CD Ruby Operator Manual 08H5602

Operators Manual
List Number 08H56-02
9239517B.indd i
12/9/2008 10:39:50 AM
Revision Status
Document Control
Numbers
LN08H56-01A/
LN08H56-02
9212934A (TEXT)
9159955A (CD ROM)
Revision
Date
May 2006
Section(s)
Revised
9140559A
Revision and Status Log
Pages Revised,
Added or Deleted
Initial release; all sections
new.
9140540AForeword
9140541A
Master Table of Contents
9140542A
List of Figures
9140543AList of Tables
9140544ASystem
Documentation
9140545A
Use or Function
9140546A
Installation Procedures and
Special Requirements
9140547A
Principles of Operation
9140548A
Performance Characteristics
and Specifications
9140549A
Operating Instructions
9140550A
Calibration Procedures
9140551A
Operational Precautions and
Limitations
9140552A
Hazards
9140553A
Service and Maintenance
CELL-DYN Ruby System Operators Manual
9140559ESeptember 2013
Document Control
Numbers
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
9140554A
Troubleshooting and
Diagnostics
9140555A
Quality Control
9140556A
Reticulocyte Package
9140561AAppendices
9140562AIndex
LN08H56-03A/
LN08H56-02B
9212934B (TEXT)
9159955B (CD ROM)
August
2006
9140559B
9140540BForeword
9140541B
9140542B
List of Figures
9140545B
Use or Function
9140549B
9140552B
Hazards
9140553B
9140561BAppendices
LN08H56-03B/
LN08H56-02C
9212934C (TEXT)
9159955C (CD ROM)
July 2008
9140559C
9140540CForeword
9140541C
9140542C
List of Figures
9140543BList of Tables
ii
Document Control
Numbers
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
9140544BSystem
Documentation
9140545C
Use or Function
9140546B
9140547B
9140548B
and Specifications
9140549C
9140550B
9140551B
Limitations
9140552C
Hazards
9140553C
9140554B
Troubleshooting and
Diagnostics
9140555B
Quality Control
9140556B
9140561CAppendices
9140562BIndex
iii
Document Control
Numbers
LN08H56-03D/
LN08H56-02E
9212934D (TEXT)
9159955F (CD ROM)
Revision
Date
December
2008
Section(s)
Revised
Pages Revised,
Added or Deleted
9140559D
9140540DForeword
9140541D
9140542D
List of Figures
9140543CList of Tables
9140545D
Use or Function
9140546C
9140547C
9140548C
and Specifications
9140549D
9140550C
9140551C
Limitations
9140552D
Hazards
9140553D
9140554C
Troubleshooting and
Diagnostics
9140555C
Quality Control
9140556C
iv
Document Control
Numbers
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
9140561DAppendices
9140562CIndex
LN08H56-03F/
LN08H56-02F
9212934E (TEXT)
9159955G (CD ROM)
September
2013
9140559E
ALL
9140540EForeword
ALL
9140541E
ALL
9140542E
List of Figures
ALL
9140543DList of Tables
ALL
9140544CSystem
Documentation
ALL
9140545E
Use or Function
ALL
9140546D
ALL
9140547D
ALL
9140548D
and Specifications
ALL
9140549E
ALL
9140550D
ALL
9140551D
Limitations
ALL
9140552E
Hazards
ALL
9140553E
ALL
9140554D
Troubleshooting and
Diagnostics
ALL
Document Control
Numbers
vi
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
9140555D
Quality Control
ALL
9140556D
ALL
9140561EAppendices
ALL
9140562DIndex
ALL
Revision Log
Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have
been added to your paper manual.
1. Record the document control number of the revised section in the first column. You will find the number in
the footer. Make an entry for each chapter you receive and place the revised section(s) in the manual.
2. Record the revision date, also found in the footer, in the second column.
3. Record the current CELL-DYN Ruby software version in the third column.
4. Write your initials or signature in the fourth column to verify that you have placed the revised page(s) in the
manual.
5. Record the date that you added the revised section to the manual in the fifth column.
Document
Control
Number
Revision
Date
Software
Version
Revision
Incorporated
by
Date
Incorporated
vii
NOTES
viii
Foreword
Congratulations on becoming the operator of a CELL-DYN Ruby. Your System,
which includes state-of-the-art technology, is designed to function consistently and
dependably from day to day.
The CELL-DYN Ruby is backed by dedicated professionals who excel in
engineering, medical technology, training, and service. As part of the customer
training program, we will teach you to operate, maintain, and troubleshoot your
System.
Abbott Laboratories is dedicated to manufacturing the highest quality, most
reliable instrumentation available. We look forward to serving your needs in any
way possible.
Customer Service
If you need information or help in diagnosing a problem, technical assistance is
available by telephone. In the USA, this service is available by calling Abbott
Diagnostics Customer Service 24 hours a day, seven days a week.
United States: 1-877-4ABBOTT (1-877-422-2688)
Canada: 1-800-387-8378
Outside of USA and Canada: Contact your Country Service and Support
Representative.
For correspondence, the address in the USA is:
Abbott Diagnostics Division
Customer Service
200 Abbott Park Road
Abbott Park, IL 60064, USA
Proprietary Statement
The CELL-DYN Ruby software programs and system documentation are protected
by copyright (2008 and 2013). All rights are reserved.
The software and manual were developed solely for use with the CELL-DYN Ruby
and for in vitro diagnostic applications as specified in the operating instructions.
The information and related graphics published herein (the Information) are the
sole property of Abbott Laboratories. Permission to use the Information is granted,
provided that:
the copyright notice appears on all copies;

use of the Information is for operation of Abbott products by Abbott trained
personnel or informational use only;
the information is not modified in any way; and
no graphics are used separate from accompanying text.
Each person assumes full responsibility and all risks arising from use of the
Information. The Information is presented as is and may include technical
inaccuracies or typographical errors. Abbott Laboratories reserves the right to
make additions, deletions, or modifications to the Information at any time without
any prior notification.
Patent Statement
The CELL-DYN Ruby is covered by one or more of the following USA Patents:
5,017,497; 5,378,633; 5,510,267; 5,733,784. Additional patents may be pending.
Disclaimers
All samples (printouts, graphics, displays, screens, etc.) are for information and
illustration purposes only and shall not be used for clinical or maintenance
evaluations. Data shown in sample printouts and screens do not reflect actual
patient names or test results. Labels depicted in the manual may appear different
from actual product labels.
Abbott Laboratories makes no representations or warranties about the accuracy and
reliability of the information contained in or printed from the CELL-DYN Ruby
Operators Manual CD-ROM.
The information was developed to be used by Abbott Laboratories trained
personnel, by other persons knowledgeable or experienced with the operation and
service of the product identified, or under the direct supervision and with
cooperation from Abbott Laboratories technical sales or service representatives.
In no event shall Abbott Laboratories or its affiliates be liable for any damages or
losses incurred in connection with or arising from the use of the information on this
media by persons not fully trained by Abbott Laboratories. This limitation shall not
apply to those persons knowledgeable or experienced with the operation and
service of the product identified, or under the direct supervision and with
cooperation from Abbott Laboratories technical sales or service representatives.
No confidential relationship shall be established in the event that any user of the
Information should make any oral, written or electronic response to Abbott
Laboratories (such as feedback, questions, comments, suggestions, ideas, etc.).
Such response and any information submitted therewith shall be considered nonconfidential, and Abbott shall be free to reproduce, publish, or otherwise use such
information for any purposes whatsoever including, without limitation, the
research, development, manufacture, service, use, or sale of products incorporating
such information. The sender of any information to Abbott is fully responsible for
its content, including its truthfulness and accuracy and its non-infringement of any
other persons proprietary rights.
Abbott Laboratories is not engaged in rendering medical advice or services.
Updates to the information may be provided in either paper or electronic format.
Always refer to the latest documents for the most current information.
ii
List numbers are unique identifiers that are used when ordering products. The list
number and quantity provided in Appendix A: Parts and Accessories are intended
for guidance only and are subject to change. Contact your Abbott representative for
the most current information regarding list numbers.
All operating instructions must be followed. In no event shall Abbott be
responsible for failures, errors, or other liabilities resulting from customers noncompliance with the procedures and precautions outlined herein.
The CELL-DYN Ruby is a Class I Laser Product per IEC 60825-1 (2007). Use of
controls or adjustments or performances of procedures other than those specified
may result in hazardous radiation exposure.
iii
Warranty Statement for USA Customers Only

Abbott Laboratories warrants the CELL-DYN Ruby Analyzer, sold by Abbott
Sales Representatives, to be free of defects in workmanship and materials during
normal use by the original purchaser. This warranty shall continue for a period of
one (1) year, commencing twenty-one (21) days from the date of shipment to the
original purchaser or until title is transferred from the original purchaser,
whichever occurs first (the Warranty Period).
If any defects occur during the Warranty Period, contact your Abbott Customer
Support Center immediately and be prepared to furnish pertinent details
concerning the defect, the model number, and the serial number.
Abbotts Warranty coverage limits are as follows:
1. Abbott Customer Service: 24 hours per day, 7 days per week phone support
in the United States.
2. Field Service Representative support: 8:30 A.M. to 5:00 P.M. Monday
through Friday (excluding all Abbott-observed holidays).
3. Any on-site service performed at other times and all service required to
correct defects or malfunctions not covered by this Warranty (as noted in the
paragraph below) will be billed at Abbotts labor rates then in effect.
This Warranty does not cover defects or malfunctions which:
1. Are not reported to Abbott during the Warranty Period and within one week
of occurrence.
2. Result from chemical decomposition or corrosion.
3. Are caused primarily by customer or third party abuse, misuse, or negligence,
or by failure to comply with any requirement or instruction contained in the
applicable Abbott Operations Manual.
4. Result from maintenance, repair, or modification performed without Abbotts
authorization.
Abbotts liability for all matters arising from the supply, installation, use, repair,
and maintenance of the Instrument, whether arising under this Warranty or
otherwise, shall be limited solely to the repair or (at Abbotts sole discretion)
replacement of the Instrument or of components thereof. In no event shall Abbott
be liable for injuries sustained by third parties, incidental or consequential
damages, or lost profits. Replaced parts shall become the property of Abbott
Laboratories.
THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT
LABORATORIES REGARDING THE INSTRUMENT; AND ABBOTT
SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR
PURPOSE.
The CELL-DYN Ruby is manufactured by Abbott Diagnostics Division, Abbott
Laboratories, Abbott Park, IL 60064, USA. Please direct all inquiries concerning
information in this manual to the foregoing address.
iv
Regulatory and Safety Agency Approvals

In Vitro Diagnostic Directive
98/79/EC
Legal Manufacturer
Abbott Laboratories
Abbott Park, IL 60064, USA
Authorized Representative
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
Trademark Statements
CELL-DYN Sapphire, CELL-DYN Ruby, eQC, MAPSS, CELL-DYN and
CELL-DYN HemCal are trademarks of Abbott Laboratories in various
jurisdictions.
All other trademarks are the property of their respective owners.
All Abbott Laboratories product names and trademarks are owned by or licensed
to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott
trademark, trade name, trade dress, or product name may be made without the prior
written authorization of Abbott Laboratories, except to identify the product or
services of Abbott Laboratories. All other trademarks, brands, product names, and
trade names are the property of their respective companies. All rights reserved.
Except as permitted above, no license or right, express or implied, is granted to any
person under any patent, trademark, or other proprietary right of Abbott
Laboratories.
Symbols
The symbols listed below are used in labeling for the CELL-DYN Ruby, including that on the instrument,
reagents, calibrator, controls, and in this manual.
Instrument/Power related
Symbol
Symbol
Definition/Use
Alternating Current
Input
PRESS 1
Pressure 1
Application Software
PRESS 2
Pressure 2
BUSY
Busy
PRESS 3
Pressure 3
FAULT
Fault
READY
AC INPUT
APPLICATION SOFTWARE
FILTER 1/2
Filter 1 or 2
FREQUENCY
Frequency
HGB
FLOW CELL
HGB Flow Cell
LINE VOLTAGE
Line Voltage
MAX POWER
Maximum Power
MIXING
CHAMBER
Mixing Chamber
MODEL
OPERATING SYSTEM
PERISTALTIC PUMP
POWER
vi
Definition/Use
Model Number
RESERVOIR
Reservoir
REV
Revision
SET-UP DISK
Set-Up Disk
SHEAR VALVE
Shear Valve
Stand By
Trap
TRAP
VAC 1/2
ON
VENT
Peristaltic Pump
Serial Number
SN
OFF
Operating System
Ready
Vacuum 1 or 2
Vent
Waste
WASTE
WASTE SENSOR
Waste Sensor
Power
Reagent related
CN-FREE HGB/NOC LYSE
DILUENT
DILUENT/SHEATH
ENZYMATIC CLEANER CONCENTRATE
Cyanide-Free Hemoglobin/Nuclear Optical Count Lyse Reagent

Diluent Reagent
Diluent/Sheath Reagent
Enzymatic Cleaner Concentrate
Use by
Hemoglobin
HGB
HGB LYSE
Hemoglobin Lyse
LOT
Batch Code
RBC
Red Blood Cell
SHEATH
Sheath Reagent
WBC
WBC LYSE
Temperature Limitation
(Example shows Store at 28C)
White Blood Cell

WBC Lyse Reagent
vii
Calibrator/Control related
ASSAY VALUE
CAL
Calibrator
CALIBRATOR
Calibrator
CONTROL
Control
CONTROL ASSAY FILES
Control Assay Files
CONTROL I/II/III or L/N/H
Control, Level I, II, or III or Level L, N, or H
CONTROL L|N|H
DANGER: SENSITIZER
Control, Tri-Level
Danger: Respiratory Sensitizer
MEAN RANGE
Mean Range
MEAN VALUE
Mean Value
PARAMETER
Parameter
REF
RETIC CONTROL
SYSTEM
viii
Assay Value
Catalogue number
Reticulocyte Control
System
Miscellaneous
EC REP
Authorized Representative in the European Community

Biological risks
Caution, consult accompanying documents
(Note: for Instrument reagents)
Caution, risk of danger / Caution, consult accompanying documents
(Note: for Instruments)
CE-mark
Consult Instructions for Use
Date of Manufacture
IVD
In Vitro Diagnostic Medical Device
REF
Catalogue Number
Separate collection for electrical and electronic equipment waste per
Directive 2002/96/EC in the European Union
Separate Collection of spent batteries per Directive 2006/66/EC in the
European Union.
Manufacturer
ix
Instrument Labeling
The following labels are affixed to the CELL-DYN Ruby.
Analyzer Rear Panel

CLASS 1 LASER PRODUCT/
Lasergert der Klasse 1/
Produit laser de classe 1/Lser de
clase 1/Prodotto laser di classe 1/
Produto laser da classe 1/Klasse 1laserprodukt/Klass 1 laserprodukt/
1 PN 9230702C
Figure 1:
Class 1 Laser Product Label
The following U.S. Patents are relevant to the CELL-DYN Ruby or its
components. There are other such patents and patent applications in the
United States and worldwide.
5,017,497 5,378,633 5,510,267 5,733,784
PN: 9231334A
Figure
2:
9221334A.indd
CELL-DYN Ruby US Patent Label
6/24/2005 9:16:12 AM
ABBOTT LABORATORIES
Abbott Park, IL 60064 USA
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
Figure 3:
PN 9230751
CE Mark and Legal Manufacturer
ABBOTT LABORATORIES
Diagnostics Division
Abbott
Diagnostics Division
EC REP
Figure 4:
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
PN 9231514A
CE Label
9221514A.indd 1
1/16/2008 12:16:45 PM
Figure 5:
ETL Certification Label
Analyzer Right Flow Panel
ABBOTT DIAGNOSTICS DIVISION

Abbott Laboratories
Abbott Park IL, 60064, USA
THIS PRODUCT COMPLIES WITH FDA

PERFORMANCE STANDARDS FOR LASER
PRODUCTS EXCEPT FOR DEVIATIONS
PURSUANT TO LASER NOTICE NO. 50,
DATED JULY 26, 2001.
Manufactured for Abbott Laboratories

Product of Singapore
PRODUCT COMPLIES WITH FDA PERFORMANCE
STANDARDS FOR LASER PRODUCTS EXCEPT
FOR DEVIATIONS PURSUANT TO LASER NOTICE
NO. 50, DATED JULY 26, 2001.
DATE OF MANUFACTURE
MODEL
MODEL
REF
SN
REF
REV
SN
PN 9230308 REV J
Figure 6:
REV
PN 9230308 REV K
Analyzer Serial Number Labels
xi
Analyzer Left Flow Panel
Figure 7:
CELL-DYN Ruby Service Technical Service Bulletin Record Label
CAUTION Class 3B laser light when open. Avoid

exposure to beam.
VORSICHT Bei offener Abdeckung Laserstrahlung der
Klasse 3B. Nicht direkt in den Laserstrahl blicken.
ATTENTION Rayon laser de classe 3B si ouvert. Eviter
toute exposition au faisceau laser.
PRECAUCIN: Haz de lser de clase 3B. Evite la
exposicin al lser cuando el analizador est abierto.
ATTENZIONE: fascio laser di classe 3B se aperto. Evitare
lesposizione al raggio.
ATENO Quando aberto, emite luz laser da classe
3B. Evitar a exposio ao raio laser.
VIGTIGT: Klasse 3B-laserlys ved bning. Undg
eksponering for strlen.
VIKTIGT: Klass 3B laserljus nr luckan r ppen. Undvik
exponering f r strlen.
3
.
.
UPOZORNN: Po oteven krytu nebezpe ozen
laserem tdy 3B. Vyvarujte se kontaktu s paprskem.
PN 9230701F
Figure 8:
Laser Warning Label
Analyzer Front and Rear
PN 9231477A
Figure 9:
xii
Biohazard

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Patent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Warranty Statement for USA Customers Only. . . . . . . . . . . . . . . . . . iv
Regulatory and Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . v
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Analyzer Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Analyzer Right Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Analyzer Left Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Analyzer Front and Rear. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Organization of the online HTML Operators Manual. . . . . . . . . . . . . 2
Conventions for the online HTML Operators Manual . . . . . . . . . . . . 5
Access to the online HTML Operators Manual from
the system software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Printed documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Access to the PDF Operators Manual from
a stand-alone computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Specimen Processing Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Specimen Loading and Presentation. . . . . . . . . . . . . . . . . . . . . . 1-5
Specimen Identification and Test Selection . . . . . . . . . . . . . . . . . . . 1-5
Test Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Analyzer Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Analyzer Right Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Analyzer Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Analyzer Sample Processing Area . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Master Table of Contents-1
Analyzer Flow Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analyzer Internal Assemblies. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analyzer Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data Module Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Flat Panel Display with Touch Screen . . . . . . . . . . . . . . . . . . . . . .
Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mouse Input Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hand-Held Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analyzer Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data Station Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Title Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Tool Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Status Bar and System Messages Region . . . . . . . . . . . . . . . . .
NOTE Region (Next Open Tube Entry) . . . . . . . . . . . . . . . . . .
Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CELL-DYN Ruby Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CELL-DYN Diluent/Sheath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CELL-DYN CN-Free HGB/NOC Lyse . . . . . . . . . . . . . . . . . . . . .
CELL-DYN WBC Lyse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CELL-DYN Reticulocyte Reagent . . . . . . . . . . . . . . . . . . . . . . . . .
Controls, Calibrator, and Standard Reference Particles . . . . . . . . . . . . . . .
Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calibrators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standard Reference Particles . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-14
1-17
1-19
1-22
1-24
1-25
1-27
1-28
1-29
1-31
1-31
1-31
1-32
1-32
1-33
1-33
1-35
1-38
1-40
1-42
1-43
1-43
1-43
1-44
1-44
1-45
1-45
1-45
1-45
Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Site Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . .
Unpacking and Inspection Guidelines . . . . . . . . . . . . . . . . . . . . . . .
System Connection and Start Up Guidelines . . . . . . . . . . . . . . . . . .
System Relocation and Shipping Guidelines . . . . . . . . . . . . . . . . . .
System Customization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-1
2-3
2-3
2-3
2-3
2-4
2-4
2-5
2-5
2-7
Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Patient Sample Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Patient Sample Setup, Limits Tab View. . . . . . . . . . . . . . . . . . 2-10
Demographics Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Customize Limit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Demographic Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Unit Sets Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Unit Format Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Customize Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Customize Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
Datalog, QC View, and Groups View . . . . . . . . . . . . . . . . . . . 2-30
Customize Moving Average View . . . . . . . . . . . . . . . . . . . . . . . 2-32
Customize Printed Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Customize Report Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
Auto Print Chartable Page Report . . . . . . . . . . . . . . . . . . . . . . 2-35
Other Printed Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
QCID Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Moving Average Acceptance Setup... . . . . . . . . . . . . . . . . . . . . . . 2-37
Administrative Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Operators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
User Interface Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Tool Tip Display Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51
QCID Daily Cleanup Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51
Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Instrument ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54
Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-56
Orders Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58
Automatic Order Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58
No Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59
LIS Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
LIS Configuration Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
LIS Tests Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
QC Download ID File Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Flag Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Logs Auto Backup Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67
Rule Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Instrument Flushed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Introduction to Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Detection with the Optical Bench. . . . . . . . . . . . . . . . . . . . . . . . 3-8
Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WBC Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
WBC Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
WBC Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Mononuclear-Polymorphonuclear Separation . . . . . . . . . . . . . 3-12
Neutrophil-Eosinophil Separation . . . . . . . . . . . . . . . . . . . . . . 3-13
Mononuclear Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Other Scatterplots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Nuclear Optical Count (NOC) . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Resistant RBC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
NWBC-LYM-MONO Histogram. . . . . . . . . . . . . . . . . . . . . . . 3-17
MONO-POLY Histogram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
NOC Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
WBC Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
RBC Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
HCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCHC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Platelet Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLT Count. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MPV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HGB Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HGB Flagging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Instrument Fault and Status Conditions . . . . . . . . . . . . . . . . . . . . .
Cell Populations and Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fragile WBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lyse-Resistant RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dispersional Data Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WBC Descriptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3-21
3-21
3-22
3-22
3-22
3-22
3-23
3-23
3-23
3-23
3-23
3-24
3-27
3-27
3-27
3-28
3-28
3-28
3-29
3-32
3-32
3-32
3-33
3-39
3-41
Performance Characteristics and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating Environment Requirements . . . . . . . . . . . . . . . . . . . .
Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating Noise Level and Heat Output. . . . . . . . . . . . . . . . . . .
Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maximum Throughput (Closed Mode). . . . . . . . . . . . . . . . . . . .
Maximum Throughput (Open Mode) . . . . . . . . . . . . . . . . . . . . .
Complete Cycle Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4-1
4-3
4-3
4-3
4-4
4-4
4-4
4-4
4-4
4-4
4-5
4-5
4-5
4-5
Nominal Aspiration Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Recommended Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Specimen Tube Dimensions (Closed Mode) . . . . . . . . . . . . . . . 4-5
Recommended Specimen Collection Tubes (Closed Mode) . . . 4-6
Recommended Volume Requirements in Specimen
Collection Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Specification for Bar Code Symbols, Bar Code Labels,
and their Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
CBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Imprecision (Reproducibility). . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Analytical Measurement Range (AMR) . . . . . . . . . . . . . . . . . . 4-14
Comparability (Correlation) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
System Priming, Interruption, and Standby . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
System Priming, Interruption, and Standby . . . . . . . . . . . . . . . . . . . 5-3
Power On and Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
System Priming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Interruption Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Procedural Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
The To Standby Task Button . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Specimen Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Specimen Analysis Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Preparing to Run Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Preparing to Run Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Signing On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Running Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Preparing and Handling Specimens . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Specimen Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Specimen Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Specimen Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Specimen Identification Methods . . . . . . . . . . . . . . . . . . . . . . .
Introduction to the Orders View . . . . . . . . . . . . . . . . . . . . . . . . . . .
Default Patient Test Selection Processing Conditions . . . . . . .
Pending Orders (Match Specimen ID or Match Rxx Tyy) . . . .
Pending Order Entries from the LIS . . . . . . . . . . . . . . . . . . . . .
Processing with the Orders View . . . . . . . . . . . . . . . . . . . . . . .
Create Manual Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Printing a Pending Orders Log . . . . . . . . . . . . . . . . . . . . . . . . .
Orders Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Post-Analysis Processing Datalog View . . . . . . . . . . . . . . . . . . . . . . . . .
Alerts and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
System Messages and Fault Conditions . . . . . . . . . . . . . . . . . .
Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Datalog View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Backing up and Restoring System Data . . . . . . . . . . . . . . . . . .
Creating an Electronic Monthly Archive on the
CELL-DYN Ruby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advanced Data Management Groups View . . . . . . . . . . . . . . . . . . . . . .
Creating Orders From the Group View . . . . . . . . . . . . . . . . . . . . .
Deleting Records From the Group View . . . . . . . . . . . . . . . . . . . .
Advanced Data Management Rules Based Annotations . . . . . . . . . . . . .
Creating Rules and Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . .
Creating Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Creating Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedure: Creating Annotations . . . . . . . . . . . . . . . . . . . . . . .
Enabling/Disabling Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rule Validation (within software) . . . . . . . . . . . . . . . . . . . . . . . . .
Evaluating Rules During Run Time . . . . . . . . . . . . . . . . . . . . . . . .
Displaying Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Printing the Rules Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Printing a Group of Specimens with Annotations . . . . . . . . . .
Importing /Exporting Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5-17
5-18
5-18
5-20
5-21
5-22
5-22
5-22
5-25
5-27
5-28
5-30
5-31
5-33
5-33
5-33
5-33
5-34
5-35
5-35
5-36
5-36
5-40
5-43
5-47
5-48
5-48
5-51
5-53
5-53
5-53
5-59
5-60
5-66
5-70
5-71
5-74
5-75
5-76
Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Bias Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Calibrating with Commercial Calibrator . . . . . . . . . . . . . . . . . . 6-6
Calibrating with Assayed Whole Blood . . . . . . . . . . . . . . . . . . . 6-6
Recommendations and Requirements for
Whole Blood Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Recommendations for Reference Methodologies. . . . . . . . . . . . 6-7
Requirements for Obtaining Whole Blood Reference Values . . 6-8
Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Pre-Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Pre-Calibration Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
CELL-DYN Ruby Pre-Calibration Procedures Checklist . . . . . . . 6-13
Calibration Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Last Auto-Calibration Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Quick Precision Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Calibration Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Auto-Calibration Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Auto-Calibration Wizard - Open . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Using Commercial Calibrator. . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Running the Open/Closed Mode Bias Check . . . . . . . . . . . . . . . . . 6-42
Whole Blood Auto-Calibration Wizard - Open Mode . . . . . . . . . . 6-45
Using Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45
Running the Open/Closed Mode Bias Check . . . . . . . . . . . . . . . . . 6-61
Running the Calibration Bias Wizard. . . . . . . . . . . . . . . . . . . . . . . 6-65
Manual Calibration Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-72
Manual Calibration Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . 6-72
Manual Calibration Primary Mode - Open . . . . . . . . . . . . . . . . 6-73
Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Backing Up Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Concepts and Guidelines. . . . . . . . . . . . . . . . . . . . . . .
Backup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manual Calibration Worksheets . . . . . . . . . . . . . . . . . . . . . . . . . . .
Worksheet 1 Open Mode Calibration - New Factors . . . . .
Worksheet 2 Open Mode Factor % Difference . . . . . . . . . .
Worksheet 3 Open Mode Calibration Range Criteria . . . . .
Worksheet 4 Calibration Verification . . . . . . . . . . . . . . . . .
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6-77
6-77
6-77
6-77
6-80
6-81
6-82
6-83
6-84
6-85
Operational Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Precautions and Requirements for System Operation . . . . . . . . . . .
Precautions Before Operation . . . . . . . . . . . . . . . . . . . . . . . . . . .
Precautions During Operation . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements for Handling Specimens . . . . . . . . . . . . . . . . . . . . . .
Interfering Substances and Conditions . . . . . . . . . . . . . . . . . . . . . . .
Limitations of Result Interpretation . . . . . . . . . . . . . . . . . . . . . . . . .
Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7-1
7-2
7-3
7-3
7-4
7-6
7-8
7-8
7-9
Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Laser Caution Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Hazard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Biological and Chemical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Spill Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Waste Handling and Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Disposing of Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Decontamination Procedure Requirements . . . . . . . . . . . . . . . . 8-8
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Physical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Service and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Recommended Service and Maintenance Schedule . . . . . . . . . . . . . . . . . . . 9-3
Service and Maintenance Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Maintenance View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Scheduled Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
As-Needed Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Special Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
System View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Calibration Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Set Point Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Reagents View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Current Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Reagent Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Scheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . 9-15
As-Needed Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-32
Special Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51
Nonscheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . 9-65
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-65
Printer Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-66
Reagent Container Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-66
Replace Tubing in Normally Closed (NC) Valves . . . . . . . . . . 9-67
Unclogging Open Mode Probe . . . . . . . . . . . . . . . . . . . . . . . . . 9-71
Vacuum Accumulator 1 and 2 Rinsing Procedure . . . . . . . . . . 9-74
CELL DYN Ruby Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . 9-75
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-77
Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Introduction to Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Problem Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Observable Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Troubleshooting Tips and Techniques . . . . . . . . . . . . . . . . . . . 10-5
List of System Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
System Information Message (SIM) Tables . . . . . . . . . . . . . . . . . 10-17
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
When to Run QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
QC Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Quality Control Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Guidelines for Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Control Material Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Assay Verification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Establishing the Mean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
QC View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Program Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
QCID Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Quality Control Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13
Using QC View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Main QC View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Scrolling Through the QC View. . . . . . . . . . . . . . . . . . . . . . . 11-15
View QC Spec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
QCID L-J Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-22
QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23
Download QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27
View QC Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-28
Moving Average View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-34
Moving Average Levey Jennings View. . . . . . . . . . . . . . . . . . . 11-36
Quality Control Software Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 11-39
QCID File Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-39
QC Download ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-59
Moving Average Acceptance Setup . . . . . . . . . . . . . . . . . . . . 11-60
Performing a QC Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-64
Rejecting/Accepting Specimens . . . . . . . . . . . . . . . . . . . . . . . 11-64
Edit QC Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-65
Moving QCID Specimen Runs from One QCID File to Another 11-67
Evaluating and Investigating Commercial and Patient Control Results. . 11-69
Analyzing QCID File Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-71
Levey-Jennings Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-71
Westgard Rule Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-72
Westgard Rules for the CELL-DYN Ruby. . . . . . . . . . . . . . . . . . 11-72
Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-73
Moving Average Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-75
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-75
How Moving Average Programs Work . . . . . . . . . . . . . . . . . . . . 11-75

Principles of Moving Average Analysis. . . . . . . . . . . . . . . . . . . . 11-76
Guidelines for Setting Up X-B Moving Average
Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-76
Establishing the Target Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-77
Guidelines for Interpreting X-B Moving Average
Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-78
Guidelines for Setting Up and Interpreting Other Moving Average
Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-79
Moving Average Program Operation . . . . . . . . . . . . . . . . . . . . . . 11-81
Data Collection Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-81
Investigating Moving Average Data Problems. . . . . . . . . . . . . . . 11-82
Investigating One Batch Out. . . . . . . . . . . . . . . . . . . . . . . . . . 11-82
Investigating Two Batches Out. . . . . . . . . . . . . . . . . . . . . . . . 11-82
Printing Moving Average Programs Information. . . . . . . . . . . . . 11-82
Customizing Moving Average Programs . . . . . . . . . . . . . . . . . . . 11-83
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-85
Reticulocyte Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
RETIC Test Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
Enabling Reticulocyte Processing . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Disable Reticulocyte Processing. . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Routine Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
Specimen Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
Specimen Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-21
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-22
Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-23
Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-25
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-25
General Guidelines for Reticulocyte Troubleshooting . . . . . . 12-25
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . 12-26
Dispersional Data Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-29
Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix B Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
NOTES
List of Figures
List of Figures
Foreword
Figure 1:
Figure 2:
Figure 3:
Figure 4:
Figure 5:
Figure 6:
Figure 7:
Figure 8:
Figure 9:
Class 1 Laser Product Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

CELL-DYN Ruby US Patent Label . . . . . . . . . . . . . . . . . . . . . . . . . . . x
CE Mark and Legal Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
CE Label for New Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
ETL Certification Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Analyzer Serial Number Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
CELL-DYN Ruby Service Technical Service Bulletin
Record Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Laser Warning Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Biohazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Use or Function
Figure 1.1
Figure 1.2
Figure 1.3
Figure 1.4
Figure 1.5
Figure 1.6
Figure 1.7
Figure 1.8
Figure 1.9
Figure 1.10
Figure 1.11
Figure 1.12
Figure 1.13
Figure 1.14
Figure 1.15
Figure 1.16
Figure 1.17
Figure 1.18
Figure 1.19
Figure 1.20
Figure 1.21
Figure 1.22
Figure 1.23
Figure 1.24
CELL-DYN Ruby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Analyzer Right Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Analyzer Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Sample Loader Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Flow Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Analyzer Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Hardware Component Cable and Connection Overview Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Data Module Computer Component Connections - Rear View . . . 1-23
Flat Panel Display (Right Side) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Flat Panel Display (Back Side) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Example of Standard English Keyboard. . . . . . . . . . . . . . . . . . . . . 1-25
Using the Mouse Input Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Hand-Held Bar Code Reader Connection. . . . . . . . . . . . . . . . . . . . 1-28
Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32
Title Bar Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Menu Bar Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Tool Bar Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38
System Messages Region Example . . . . . . . . . . . . . . . . . . . . . . . . 1-39
NOTE Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
NOTE Detailed (More Spec Info Window) . . . . . . . . . . . . . . . . . . 1-41
QCID Lookup Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
Function Key Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
List of Figures-1
List of Figures
Installation Procedures and Special Requirements

Figure 2.1
User Interface Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Figure 3.1
Figure 3.2
Figure 3.3
Figure 3.4
Figure 3.5
Figure 3.6
Figure 3.7
Figure 3.8
Figure 3.9
Figure 3.10
Figure 3.11
Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Mononuclear-Polymorphonuclear Scatter . . . . . . . . . . . . . . . . . . . 3-12
Neutrophil-Eosinophil Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
RBC Data and Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
PLT Data and Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Performance Characteristics and Specifications

Figure 4.1
Figure 4.2
Figure 4.3
Bar Code Symbol Dimensions & Label Requirements . . . . . . . . . . 4-7

Bar Code Label Placement Requirements . . . . . . . . . . . . . . . . . . . . 4-9
Tube with Correctly Positioned Bar Code Label in a
Sample Loader Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Figure 5.1
Figure 5.2
Figure 5.3
Figure 5.4
Figure 5.5
Figure 5.6
Power Switch Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Datalog Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Rule Setup Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Add new Rule dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Single Record View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Printed Specimen Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-72
Figure 8.1
Figure 8.2
Figure 8.3
Class 1 Laser Product Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Laser Warning Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
CELL-DYN Ruby System Laser Caution Labeling . . . . . . . . . . . . . 8-4
Hazards
List of Figures-2
List of Tables
List of Tables
Use or Function
Table 1.1
Table 1.2
Table 1.3
Table 1.4
Table 1.5
Table 1.6
Table 1.7
Table 1.8
Table 1.9
Status Indicator LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Reagent Inlet Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Keyboard Keys and Their Functions on the CELL-DYN Ruby. . . 1-26
Mouse Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Printing Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Menu Bar Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Tool Bar Button Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Status Bar Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Tab Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42

Table 2.1
Table 2.2
Table 2.3
Table 2.4
Table 2.5
Table 2.6
Table 2.7
Table 2.8
Table 2.9
Table 2.10
Table 2.11
Table 2.12
Table 2.13
Table 2.14
Table 2.15
Table 2.16
Table 2.17
Table 2.18
Table 2.19
Table 2.20
Table 2.21
Table 2.22
Table 2.23
Table 2.24
Customizable Menu Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Limit Set Default Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
To Change the User Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
To Select the Default Patient Test Selection . . . . . . . . . . . . . . . . . 2-22
Procedure to Change the Unit Sets Selection . . . . . . . . . . . . . . . . . 2-23
Procedure to Customize Parameter Set - Chartable Page . . . . . . . . 2-25
Customize the Run View - Lab Page . . . . . . . . . . . . . . . . . . . . . . . 2-27
Procedure to Customize the Run View - Graphs Page . . . . . . . . . . 2-29
Procedure to Customize Tab Titles and Column Headings
in Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Procedure to Add/Delete Tab Pages in Data View. . . . . . . . . . . . . 2-32
To Customize the Printed Report Header . . . . . . . . . . . . . . . . . . . . 2-34
Procedure to Auto Print Chartable Page Report . . . . . . . . . . . . . . . 2-35
Procedure to Print Using Other Printed Report Options. . . . . . . . . 2-36
Operator ID and Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
Procedure to Add an Operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40
Add Operator Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Procedure to Remove an Operator . . . . . . . . . . . . . . . . . . . . . . . . . 2-42
Procedure to Edit Operator Information . . . . . . . . . . . . . . . . . . . . . 2-43
Edit Operator Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44
Procedure for Editing Permission Access Rights for Laboratory
Levels I and II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Procedure for Setting Up Second Sign Ons . . . . . . . . . . . . . . . . . . 2-48
Changing the Tool Tip Display Time . . . . . . . . . . . . . . . . . . . . . . . 2-51
Procedure to Set Up Bar Code Including Symbology Setups . . . . 2-56
Procedure to Change Automatic Order Cleanup . . . . . . . . . . . . . . 2-59
9140543DSeptember 2013
List of Tables-1
List of Tables
Table 2.25
Table 2.26
Table 2.27
Table 2.28
Procedure to Change Use Rack and Tube Matching . . . . . . . . . . .

Setting Up Auto-Transmission and Manual Transmission. . . . . . .
Flag Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Logs Auto Backup Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2-60
2-62
2-66
2-67
5-Part Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5-Part Differential Plus Additional Parameters . . . . . . . . . . . . . . .
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Parameters Marked With an Asterisk (*) . . . . . . . . . . . . . . . . . . . .
Parameters with Suppressed Results. . . . . . . . . . . . . . . . . . . . . . . .
Patient Specimen Type + CBC Test Selection . . . . . . . . . . . . . . . .
Patient Specimen Type + CBC+RRBC Test Selection . . . . . . . . .
Patient Specimen Type + CBC+NOC Test Selection. . . . . . . . . . .
3-25
3-25
3-29
3-30
3-31
3-34
3-37
3-38
Table 3.1
Table 3.2
Table 3.3
Table 3.4
Table 3.5
Table 3.6
Table 3.7
Table 3.8

Table 4.1
Table 4.2
Table 4.3
Table 4.4
Table 4.5
Table 4.6
Table 4.7
Table 4.8
Table 4.9
Table 4.10
Table 4.11
Table 4.12
Table 4.13
Table 4.14
Table 4.15
CELL-DYN Ruby Physical Specifications. . . . . . . . . . . . . . . . . . . . 4-3

CELL-DYN Ruby Power Specifications . . . . . . . . . . . . . . . . . . . . . 4-3
CELL-DYN Ruby Fuse Specifications. . . . . . . . . . . . . . . . . . . . . . . 4-3
Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Clearance Requirements for Service Access . . . . . . . . . . . . . . . . . . 4-4
Recommended Collection Tube Dimensions for use in Closed mode. 4-5
Recommended Specimen Collection Tubes for use in Closed Mode 4-6
Characteristics of the Bar Code Symbologies Supported by the
CELL-DYN Ruby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Background Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Reticulocyte Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Fresh Blood Imprecision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Analytical Measurement Range . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Comparability (Correlation) of CBC and Differential to
CELL-DYN Sapphire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Comparability (Correlation) of WBC Differential to Microscopy . 4-16
Table 5.1
Table 5.2
Table 5.3
List of Tables-2
Procedure to Power-up the Instrument When the System Main Power

Switch is in ON Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Procedure to Power-up the Instrument When the System Main Power
Switch is in OFF Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Procedure to Power Off and Reboot the System . . . . . . . . . . . . . . . 5-6
List of Tables
Table 5.4
Table 5.5
Table 5.6
Table 5.7
Table 5.8
Table 5.9
Table 5.10
Table 5.11
Table 5.12
Table 5.13
Table 5.14
Table 5.15
Table 5.16
Table 5.17
Table 5.18
Procedure to Power-Down the Instrument and Power Off the System

Main Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Sample Loader Interruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Procedure to Manually Place the System in Standby State . . . . . . 5-10
Specimen Analysis Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Required Procedures for Specimen Analysis . . . . . . . . . . . . . . . . . 5-14
Processing With Default Patient Test Selection . . . . . . . . . . . . . . . 5-21
Procedure to Edit Pending Orders . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Procedure to Delete Pending Order Entries . . . . . . . . . . . . . . . . . . 5-29
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Datalog Specimen Type Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Datalog Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
Fields Rule Setup Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Buttons Rule Setup Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Procedure: Creating Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54
Table 6.1
Table 6.2
Table 6.3
Table 6.4
Table 6.5
Table 6.6
Table 6.7
Table 6.8
Table 6.9
Table 6.10
Table 6.11
Table 6.12
Table 6.13
Table 6.14
Table 6.15
Table 6.16
Table 6.17
Table 6.18
Table 6.19
Table 6.20
Auto-Calibration Wizard Reference Value and Assay Value

Entry Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Buttons Last Auto-Calibration Data... . . . . . . . . . . . . . . . . . . . . 6-18
Fields Quick Precision Check... Dialog Box . . . . . . . . . . . . . . . 6-19
Buttons Quick Precision Check... Dialog Box. . . . . . . . . . . . . 6-19
Fields Calibration Log View . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Buttons Calibration Log Dialog View . . . . . . . . . . . . . . . . . . . . 6-21
Fields Manual Calibration... Dialog Box. . . . . . . . . . . . . . . . . . 6-23
Buttons Manual Calibration... Dialog Box . . . . . . . . . . . . . . . . 6-23
Buttons Welcome to the CELL-DYN Auto Calibration Wizard 6-27
Buttons Pre-Calibration Maintenance Check Status Dialog Box6-27
Buttons Pre-Calibration Reagent/Waste Dialog Box. . . . . . . . . 6-28
Buttons Pre-Calibration Precision Check Status Dialog Box . . 6-29
Buttons Pre-Calibration Background Check Status Dialog Box 6-32
Buttons Calibration Setup Dialog Box . . . . . . . . . . . . . . . . . . . 6-33
Fields Calibration Setup - Reference Values for Calibration . . 6-35
Buttons Calibration Setup - Reference Values for Calibration
Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
Buttons Auto-Calibration Data View Dialog Box. . . . . . . . . . . 6-38
Fields Post-Calibration New Factors Dialog Box . . . . . . . . . . . 6-39
Buttons Post-Calibration New Factors Dialog Box . . . . . . . . . . 6-39
When to Select Apply New Factor for Acceptance . . . . . . . . . . . . 6-40
List of Tables-3
List of Tables
Table 6.21
Table 6.22
Table 6.23
Table 6.24
Table 6.25
Table 6.26
Table 6.27
Table 6.28
Table 6.29
Table 6.30
Table 6.31
Buttons Welcome to the CELL-DYN Auto-Calibration Wizard

Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46
Buttons Pre-Calibration Maintenance Check Status Dialog Box6-47
Buttons Pre-Calibration Reagent/Waste Dialog Box. . . . . . . . . 6-48
Buttons Pre-Calibration Precision Check Status Dialog Box . . 6-49
Buttons Pre-Calibration Background Check Status Dialog Box 6-52
Buttons Calibration Setup Dialog Box . . . . . . . . . . . . . . . . . . . 6-53
Buttons Calibration Setup - Reference Values for Whole Blood
Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54
Buttons Auto-Calibration Data View Dialog Box. . . . . . . . . . . 6-56
Fields Post-Calibration New Factors Dialog Box . . . . . . . . . . . 6-58
Buttons Post-Calibration New Factors Dialog Box. . . . . . . . . . 6-58
When to Select Apply New Factor for Acceptance . . . . . . . . . . . . 6-59
Operational Precautions and Limitations

Table 7.1
Recommended Collection Tube Dimensions for Use in Closed Mode 7-6
Table 8.1
Table 8.2
Safety Icons and Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Hazard Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Hazards

Table 9.1
Table 9.2
Table 9.3
Table 9.4
Scheduled Service and Maintenance Procedures . . . . . . . . . . . . . . .

As-Needed Service and Maintenance Procedures . . . . . . . . . . . . . .
Nonscheduled Service and Maintenance Procedures . . . . . . . . . . . .
Special Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9-4
9-4
9-4
9-7
Quality Control
Table 11.1
Table 11.2
Table 11.3
Table 11.4
Table 11.5
Table 11.6
Table 11.7
Table 11.8
Table 11.9
Table 11.10
Table 11.11
Table 11.12
Table 11.13
List of Tables-4
Screen Navigation Bar and Buttons . . . . . . . . . . . . . . . . . . . . . . .

QC View Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Function Keys View QC Spec . . . . . . . . . . . . . . . . . . . . . . . . .
Function Keys QCID File Levey-Jennings View . . . . . . . . . .
Function Keys QCID Data Dialog Box . . . . . . . . . . . . . . . . . .
Field QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . . . .
Buttons QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . .
Fields QCID Setup: View, Control Data Dialog Box . . . . . . .
Fields QCID Setup: View, QC Limits Dialog Box . . . . . . . . .
Fields QCID Setup: View, Westgard Dialog Box . . . . . . . . . .
Buttons QCID Setup: View, Control Data Dialog Box . . . . . .
Function Keys QC Moving Average View . . . . . . . . . . . . . . .
Function Keys-Levey Jennings View . . . . . . . . . . . . . . . . . . . . . .
11-16
11-17
11-20
11-22
11-24
11-28
11-28
11-30
11-30
11-31
11-31
11-35
11-36
List of Tables
Table 11.14
Table 11.15
Table 11.16
Table 11.17
Table 11.18
Table 11.19
Table 11.20
Table 11.21
Table 11.22
Table 11.23
Table 11.24
Table 11.25
Table 11.26
Table 11.27
Table 11.28
Table 11.29
Table 11.30
Table 11.31
Table 11.32
Table 11.33
Table 11.34
Table 11.35
Table 11.36
Table 11.37
Table 11.38
Table 11.39
Table 11.40
Table 11.41
Table 11.42
Table 11.43
Table 11.44
Function Keys-Selected Batch Data View . . . . . . . . . . . . . . . . . .

Field QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . . . .
Buttons QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . .
Field QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . . . .
Buttons QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . .
Field QCID Setup: Create New, Control Data Dialog Box . . .
Buttons QCID Setup: Create New, Control Data Dialog Box.
Field QCID Setup: Create New, QC Limits Dialog Box. . . . .
Buttons QCID Setup: Create New, QC Limits Dialog Box . .
Field Means and Limits [+/-] Update Details Dialog Box. . . .
Buttons Update Details Dialog Box. . . . . . . . . . . . . . . . . . . . .
Field QCID Setup: Create New, Westgard Dialog Box . . . . .
Buttons QCID Setup: Create New, Westgard Dialog Box . . .
Field QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . . . .
Buttons QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . .
Field QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . . . .
Buttons QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . .
Field Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Field QCID Setup: Create New, QC Limits Dialog Box. . . . .
Field Means and Limits [+/-] Update Details Dialog Box. . . .
Buttons Update Details Dialog Box. . . . . . . . . . . . . . . . . . . . .
Field QCID Setup: Create New, Westgard Dialog Box . . . . .
Buttons QCID Setup: Create New, Westgard Dialog Box . . .
Field QC Download ID File Setup Dialog Box. . . . . . . . . . . .
Buttons QC Download ID File Setup Dialog Box. . . . . . . . . .
Field Moving Average Acceptance Setup Dialog Box . . . . . .
Buttons Moving Average Acceptance Setup Dialog Box . . . .
Field Customized Moving Average View Dialog Box . . . . . .
Buttons Customize Moving Average View Dialog Box . . . . .
Troubleshooting X-B RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
X-B WBC ValuesDefault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11-37
11-40
11-40
11-40
11-41
11-42
11-43
11-44
11-45
11-46
11-46
11-49
11-50
11-51
11-51
11-51
11-52
11-53
11-54
11-54
11-55
11-56
11-56
11-59
11-60
11-61
11-61
11-62
11-63
11-78
11-80
Table 12.1
Table 12.2
Table 12.3
Known or Potential Interferences . . . . . . . . . . . . . . . . . . . . . . . . . 12-14

Instrument Alert Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26
Data Invalidating Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-27
List of Tables-5
List of Tables
Parts and Accessories

Table A.1
Table A.2
Table A.3
Table A.4
Table A.5
Table A.6
CELL-DYN Ruby Hardware List Numbers . . . . . . . . . . . . . . . . . . . A-1

CELL-DYN Ruby Accessories Kit (List Number 09H04-01) . . . . . A-2
CELL-DYN Ruby Optional Accessories . . . . . . . . . . . . . . . . . . . . . A-3
CELL-DYN Ruby Support Documentation List Numbers. . . . . . . . A-4
CELL-DYN Calibrator and Controls for use on CELL-DYN Ruby A-4
CELL-DYN Reagents for use on CELL-DYN Ruby . . . . . . . . . . . . A-5
Potential Causes of Spurious Results

Table B.1
List of Tables-6
Potential Causes of Spurious Results with Automated

Cell Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
System Documentation
Introduction
Documentation for the CELL-DYN Ruby consists of the CELL-DYN Ruby
Operators Manual, available in both online HTML version and printed versions.
Also available on the install CD in Portable Document Format (PDF).
The Operators Manual contains instructions for using and maintaining the
CELL-DYN Ruby. It provides information that ranges from step-by-step operating
instructions to a list of parts and accessories.
The online HTML Operators Manual is designed to be the fastest, easiest, and
most user-friendly resource for your informational needs. The online HTML
Operators Manual (CELL-DYN Ruby Operators Manual) contains the same
content as the printed operators manual, which includes complete instructions for
using and maintaining the CELL-DYN Ruby. You can access the online HTML
Operators Manual from the software on the CELL-DYN Ruby data station.
The first and most important step toward learning to use this manual is to become
familiar with its organization. To assist you, System Documentation topics include:
Online HTML documentation
Printed documentation
Online PDF documentation
Online HTML documentation

Online HTML documentation topics include:
Organization of the online HTML Operators Manual
Conventions for the online HTML Operators Manual
Access to the online HTML Operators Manual from the system software
Access to the online PDF Operators Manual for a stand-alone computer
9140544CSeptember 2013

NOTE: Due to inconsistent nature of printing in HTML documents, we
recommend that you use the PDF version of the manual for printing.
The online HTML CELL-DYN Ruby Operators Manual is organized as follows:
Table 1: Online Operators Manual Organization
Revision Status and

Log
Refer to this section for the Revision Status and History of the
CELL-DYN Ruby Operators Manual.
Foreword
Refer to this section for important information such as:

Customer Service Contact Information
Proprietary and Patent Statements
Disclaimers
Warranty details
Trademark statements
Key to symbols and instrument labeling
Master Table of
Contents
Refer to the Table of Contents for a list of all:

Sections
Subsections
List of Figures
List of Tables
System
Documentation
Refer to this section for:

Information on content organization
Section 1 Use or
Function
Refer to this section for a brief description of the CELL-DYN Ruby, such as:
Intended use
Specimen processing sequence
Main hardware components
Basic features of the system software
Reagents, Controls, Calibrator, and Standard Reference Particles
Section 2 Installation
Procedures and

Information on site requirements for installation
System installation and start-up guidelines
System software customization and procedural guidelines
System relocation and shipping guidelines
Table 1: Online Operators Manual Organization (Continued)
Section 3 Principles
of Operation
Refer to this section for an explanation of:

Scientific and technical principles
Types of system measurements
Data analysis and parameter reporting conventions
System Initiated Messages (SIMs) and Data Flags
Section 4
Performance
Characteristics and
Specifications
Refer to this section for details such as:

Dimensions of the instrument
Power requirements
Environmental specifications
Operational specifications
Bar Code specifications
Performance specifications and performance characteristics
Section 5 Operating
Instructions
Use this section to learn how to perform:

Various tasks related to routine system operation
System customization
Background counts
Basic and advanced patient data management including reviewing,
printing, and transmitting to Laboratory Information Systems
Section 6 Calibration
Procedures
Use this section to learn:

When to calibrate
Pre-Calibration procedures
Calibration procedures
Post-Calibration procedures
Section 7 Operational
Precautions and
Limitations
Refer to this section to understand the precautions, limitations, and

requirements associated with:
System operation
Handling consumables
Handling specimens
Identifying substances and conditions
Interpreting results
Section 8 Hazards
Refer to this section for important hazard and safety information, such as:
Safety icons, laser caution labels, and hazard symbols
Biological, chemical, electrical, mechanical, and physical hazards
Section 9 Service and

Maintenance

Descriptions of all maintenance procedures
Recommended schedules for service and maintenance
Instructions for performing scheduled and as-needed maintenance
procedures
Step-by-step instructions for replacing components
Section 10
Troubleshooting and
Diagnostics

Troubleshooting basics and procedures
Information on probable causes and corrective actions for observed
problems, System Initiated Messages (SIMs), and Data-Related problems
Section 11 Quality
Control

Internal and external quality control programs
Principles and procedures for running quality control using commercial
control material and whole blood patient controls
Procedures to customize system quality control files
Quality control data management
Section 12
This section is a self-contained module that describes how the Reticulocyte

Package software enables the operator of the CELL-DYN Ruby System to
analyze a whole blood specimen for reticulocytes.
Appendix A
Refer to this section for information that may be helpful when ordering
products:
List Numbers
Unique Identifiers
Appendix B
Refer to this section for information on potential causes of spurious results.
Index
Use this alphabetical listing of subject matter to link to specific information in

the operators manual about the system.

Conventions are a set of defined standards and are used to convey meaning in an
expected manner. The conventions used in the online HTML Operators Manual
are intended to facilitate finding, reading, understanding, and using the available
information.
Table 2: Online HTML Operators Manual Text Conventions
Description
Use
Examples
Blue, boldface, italic, underlined
Indicates hyper-text links to

related information
Section 7: Operational Precautions and Limitations
Courier font
Text entries
type admin
Sans serif font, boldface, all capital

letters
Window name
DATA LOG window
Sans serif font, boldface, initial capital

letters
Window area, Menus and

menu items
Data Set Fields area Setup

menu

letters, enclosed in brackets
Screen message or other

screen display
[Waste Full] text

letters, enclosed in angle brackets
Data entry field
<Operator ID> field
Sans serif font, initial capital letters
Status or state
Standby status
Initialized status
Ready state
Serif font, boldface, all capital letters,

followed by colon and tab before text
Note, Caution, Warning
NOTE: text
Serif font, boldface, initial capital letters
Screen buttons
Data Log button
Serif font, all capital letters
ON, OFF
set to ON
set to OFF
Serif font, initial capital letters only when

appropriate
Keyboard keys
Function keys (F1) key

arrow keys
arrow key
Enter key
ESC key
Page Up key
pound (#) key
asterisk (*) key
Table 3: Online HTML Operators Manual Graphic Conventions
Description
Use
Examples
Signal words
Highlight information that is relevant to the

current subject matter.
NOTE:
CAUTION:
WARNING:
Numerical references on illustrations,

photographs and reports
Indicate the area described in the table

that follows or in a sidebar embedded in
the Figure.
Access to the online HTML Operators Manual from the system

software
From the Menu Bar, select the Help menu. From the Help menu, select Operators
Manual. If the manual has not yet been installed you will see a message box with
the message: Operators manual has not been installed.
Table 4: Online HTML Operators Manual Search Navigation
Actions
Steps
Reference
Using the
table of
contents
1. Select the Contents tab on the

navigation pane to provide a visual table
of contents of the operators manual
(See graphic to the right).
2. Select the box icons and page icons to

view subsections.
NOTE: The box icons expand and

collapse corresponding
subsections as they are selected.
3. Click on the desired topic to select that
topic. The topic page displays in the
topic pane (right side of window).
Scrolling
through the
content

navigation pane (see graphic to the
right), and then select a topic title. The
topic content displays in the topic pane.
11
2. Drag the scroll bar on the right side of

the topical pane to display subsequent
content within the section.
1A
3. Repeat step 2 as often as desired.
Paging
between
sections

navigation pane and select a topic title.
The desired topic then displays in the
topic pane.
2. Select a left or right section arrow

(located in the upper right-hand corner of
the topic pane) to move between
sections of the manual (see graphic to
the right).
NOTE: Section arrows are also
visible at the bottom of the topic
pane when viewing the end of a
section.
Table 4: Online HTML Operators Manual Search Navigation (Continued)
Actions
Steps
Using the
index
1. Select the Index tab on the navigation

pane (see graphic to the right).
Reference
1
2. Type in a keyword to find all references

to the keyword within the manual. Or,
click on any topic in the Index.
The topic content displays in the topic pane.
Using the
Search
button
1. Select the Search button (see graphic to

the right).
2. Type a keyword (or phrase) in the field
indicated and select List Topics
1
2
3. Review the topics displayed in the

results pane and double-click on a topic
for further review. This topic is then
displayed in the topic pane.
4. To search for new content, type another
keyword (or phrase) in the field indicated
and select List Topics.
Printed documentation
The printed version of the CELL-DYN Ruby Operators Manual contains complete
instructions for using and maintaining the CELL-DYN Ruby system. You will find
it a valuable aid and an essential reference as you learn to use the system.
Printed documentation topics include:
Organization of the printed operators manual
Conventions for the printed documentation
Organization of the printed operators manual
The printed CELL-DYN Ruby Operators Manual provides the following tools to
help you access desired information:
Tabs
Primary tabs mark the start of each section. Subtabs mark the start of subsections
within certain sections.
Tables of Contents
The Master Table of Contents at the beginning of the manual lists each section and
its subsections. Section tables of contents are located immediately behind primary
tabs in all major sections.
The printed CELL-DYN Ruby Operators Manual is organized as follows:
Table 5: Online Operators Manual Organization
Revision Status and

Log
Refer to this section for the Revision Status and History of the
CELL-DYN Ruby Operators Manual.
Foreword
Refer to this section for important information such as:

Customer Service Contact Information
Proprietary and Patent Statements
Disclaimers
Warranty details
Trademark statements
Key to symbols and instrument labeling
Master Table of
Contents
Refer to the Table of Contents for a list of all:

Sections
Subsections
List of Figures
List of Tables
System
Documentation

Information on content organization
Section 1 Use or
Function
Refer to this section for a brief description of the CELL-DYN Ruby, such as:
Intended use
Specimen processing sequence
Main hardware components
Basic features of the system software
Section 2 Installation
Procedures and

Information on site requirements for installation
System installation and start-up guidelines
System software customization and procedural guidelines
System relocation and shipping guidelines
Section 3 Principles
of Operation
Refer to this section for an explanation of:

Scientific and technical principles
Types of system measurements
Data analysis and parameter reporting conventions
System Initiated Messages (SIMs) and Data Flags
Section 4
Performance
Characteristics and
Specifications
Refer to this section for details such as:

Dimensions of the instrument
Power requirements
Environmental specifications
Operational specifications
Bar Code specifications
Performance specifications and performance characteristics
Section 5 Operating
Instructions
Use this section to learn how to perform:

Various tasks related to routine system operation
System customization
Background counts
Basic and advanced patient data management including reviewing,
printing, and transmitting to Laboratory Information Systems
Section 6 Calibration
Procedures
Use this section to learn:

When to calibrate
Pre-Calibration procedures
Calibration procedures
Post-Calibration procedures
10
Section 7 Operational
Precautions and
Limitations
Refer to this section to understand the precautions, limitations, and

requirements associated with:
System operation
Handling consumables
Handling specimens
Identifying substances and conditions
Interpreting results
Section 8 Hazards
Refer to this section for important hazard and safety information, such as:
Safety icons, laser caution labels, and hazard symbols
Biological, chemical, electrical, mechanical, and physical hazards
Section 9 Service and

Maintenance

Descriptions of all maintenance procedures
Recommended schedules for service and maintenance
Instructions for performing scheduled and as-needed maintenance
procedures
Step-by-step instructions for replacing components
Section 10
Troubleshooting and
Diagnostics

Troubleshooting basics and procedures
Information on probable causes and corrective actions for observed
problems, System Initiated Messages (SIMs), and Data-Related problems
Section 11 Quality
Control

Internal and external quality control programs
Principles and procedures for running quality control using commercial
control material and whole blood patient controls
Procedures to customize system quality control files
Quality control data management
Section 12
This section is a self-contained module that describes how the Reticulocyte

Package software enables the operator of the CELL-DYN Ruby System to
analyze a whole blood specimen for reticulocytes.
Appendix A
Refer to this section for information that may be helpful when ordering
products:
List Numbers
Unique Identifiers
Appendix B
Refer to this section for information on potential causes of spurious results.
Index
Use this alphabetical listing of subject matter to link to specific information in

the operators manual about the system.
11
Conventions for the printed operators manual

Conventions are a set of defined standards and are used to convey meaning in an
expected manner. The conventions used in the printed operators manual are
intended to facilitate finding, reading, understanding, and using the available
information.
Table 6: Printed Operators Manual Text Conventions
Description
Use
Examples
Boldface, italic
Indicates related reference

section that provides information
to the topic or procedure
Section 7: Operational Precautions and Limitations
Courier font
Text entries
type admin
Sans serif font, boldface, all

capital letters
Window name
DATA LOG window
Sans serif font, boldface, initial

capital letters
Window area, Menus and menu

items
Data Set Fields area Setup

menu

capital letters, enclosed in
brackets
Screen message or other screen

display
[Waste Full] text

capital letters, enclosed in angle
brackets
Data entry field
<Operator ID> field
Sans serif font, initial capital

letters
Status or state
Standby status
Initialized status
Ready state
Serif font, boldface, all capital

letters, followed by colon and tab
before text
Note, Caution, Warning
NOTE: text
Serif font, boldface, initial capital

letters
Screen buttons
Data Log button
Serif font, all capital letters
ON, OFF
set to ON set to OFF
Serif font, initial capital letters only

when appropriate
Keyboard keys
Function keys (F1) key

arrow keys
arrow key
Enter key
ESC key
Page Up key
pound (#) key
asterisk (*) key
12
Table 6: Printed Operators Manual Text Conventions (Continued)
Description
Use
Examples
Signal words
Highlight information that is

relevant to the current subject
matter.
NOTE:
CAUTION:
WARNING:
Numerical references on
illustrations, photographs and
reports
Indicate the area described in the

table that follows or in a sidebar
embedded in the Figure.
13
Access to the PDF Operators Manual from a stand-alone computer

NOTE: Due to inconsistent nature of printing in HTML documents, we
recommend that you use the PDF version of the manual for printing.
To access the PDF operators manual from a stand-alone computer:
NOTE: Adobe Acrobat Reader must be installed in order to open the PDF
operators manual on a stand-alone computer.
1. Insert the CELL-DYN Ruby Operators Manual CD-ROM into the CD-ROM
drive of a stand-alone computer.
2. Click Start, select Run..., type D: (where D: represents the location of your
systems CD-ROM drive), select the OK button and wait for the drive
window contents to display.
NOTE: If you are unable to access the CD-ROM drive, contact your
laboratory computer specialist to troubleshoot your stand-alone computer.
3. Double click on the CELL-DYN.txt file to verify the compatibility between
the CELL-DYN Ruby Online PDF Operators Manual CD-ROM contents
and your laboratorys current CELL-DYN Ruby System software version in
use.
4. Double click on the CDROM_List_Number_Page folder to access and
review the media disclaimer.
5. Double click on the Operators_Manual_Full folder to access the
CELL-DYN Ruby Online PDF Operators Manual complete text.
NOTE: The Operators_Manual_Update folder may either be empty or
contain the individual section(s) that had been updated in the
Operators_Manual_Full folder. This update folder can be used to print the
updated pages and add them to your existing printed version operators
manual.
6. Use any of the optional Acrobat Reader search features to navigate through
the PDF operators manual. See Table 5 below for navigation options.
7. Upon completion, remove the CD-ROM from the CD-ROM drive.
14
Table 7: PDF Operators Manual Search Navigation
Actions
Steps
Reference
Using the
table of
contents
1. Select the Bookmarks tab on the

navigation pane to provide a visual table
of contents of the operators manual
(See the graphic to the right).
2. Select the + symbols next to the book
icons to view subsections.
2
3
NOTE: You can select the

symbol to collapse the list.
3. Use the scroll bar to the right of the
navigation pane to view additional content.
4. Click on the icon to the left of the topic to

select that topic.
The topic page displays in the topic
pane (right side of window).
Paging
through
the content

navigation pane (see graphic to the
right), and then select a topic title.
4 2
The topic content displays in the

topic pane.
2. Select the Next Page button on the
toolbar to display the next page of the
manual.
3. Repeat step 2 as often as desired.
4 2
4. Select the Previous Page button to

display the previous page of the manual
(optional).
NOTE: You can also use the scroll
bar to the right of the topic pane to
page through the content.
Using the
index
1. Select the Table of Contents or Index tab

on the navigation pane (see graphic to
the right).
2. Click on any topic in the Master Table of
Contents or Index.
1
2
The topic content displays in the

topic pane.
Using the
Find
button
1. Select the Find button (see graphic to

the right).
15
Table 7: PDF Operators Manual Search Navigation (Continued)

2. Type a word or phrase in the Find What:
field and select Find (see graphic to the
right).
The topic content is highlighted
and displays in the topic pane. The
Text Not Found window will display
if no occurrences were found.
NOTE: You can refine your
searches by checking the Match
Whole Word Only, Match Case and
Find Backwards selections. Type
any combination of letters (a-z) and
numbers (0-9).
3. Select the Find Again button (see
graphic to the right) to find the next
occurrence of the word or phrase in the
manual.
NOTE: The Find Again button will
continue to search to the end of the
manual and display a warning
message. Choose OK to continue
searching from the beginning of the
manual or select the Cancel to end
the search.
4. Select the Cancel button to cancel the
search (optional).
5. Type another word or phrase in the Find
What field and select Find (optional).
Using the
Glossary

navigation pane, and then select the
Glossary title (see graphic to the right).
The alphabetized list of terms and
definitions displays in the topic
pane.
2. Use the scroll bar to the right of the topic
pane, as required, to display the desired
word and definition.
16
Section 1 Use or
Function
Section 1
Use or Function
Overview
The CELL-DYN Ruby System is a multi-parameter automated hematology
analyzer designed for in vitro diagnostic use in clinical laboratories. The
instruments utilization of the MAPSS (Multi-Angle Polarized Scatter Separation)
technology, laser flow cytometry, coupled with state of the art software, provides
you with the latest in automation available from Abbott Hematology.
Other features on the CELL-DYN Ruby include a Microsoft Windows Operating
System, USB connectivity on the data module to allow the interface of a wide
variety of printer types, and a standard hand-held bar code reader to help expedite
patient specimen identification.
.
Figure 1.1
CELL-DYN Ruby
Section 1: Use or Function presents a brief description of the CELL-DYN Ruby.

This description includes the following:
Intended Use
Specimen Processing Sequence
Main Hardware Components
Basic Features of the System Software
The scientific basis of the CELL-DYN Ruby methodology is presented in
Section 3: Principles of Operation.
1-1
Use or Function
Overview
Section 1
Intended Use
The CELL-DYN Ruby System is a multi-parameter, automated hematology
analyzer intended for in vitro diagnostic use in the clinical laboratories.
1-2
Section 1
Use or Function
Indications for Use

The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood
and report the following hematological parameters:
White Blood Cell Parameters
WBC: White Blood Cell concentration
NEU: Neutrophil absolute concentration
%N: Neutrophil percentage of WBC
LYM: Lymphocyte absolute concentration
%L: Lymphocyte percentage of WBC
MONO: Monocyte absolute concentration
%M: Monocyte percentage of WBC
EOS: Eosinophil absolute concentration
%E: Eosinophil percentage of WBC
BASO: Basophil absolute concentration
%B: Basophil percentage of WBC
Platelet Parameters
PLTPlatelet concentration
MPVMean Platelet Volume
Red Blood Cell Parameters
RBCRed Blood Cell concentration
HCTHematocrit
MCVMean Cell Volume
RDWRed Cell Distribution Width
%RReticulocyte Percent
RETCReticulocyte absolute concentration
Hemoglobin Parameters
HGBHemoglobin concentration
MCHMean Cell Hemoglobin
MCHCMean Cell Hemoglobin Concentration
1-3
Use or Function
Section 1
Overview
NOTES
1-4
Section 1
Use or Function

This subsection describes how the hardware, reagents, and software components of
the CELL-DYN Ruby interact to create the Specimen Processing Sequence. This
sequence is as follows:
Specimen Loading and Presentation
Specimen Identification and Test Selection
Specimen Loading and Presentation

The CELL-DYN Ruby provides two ways to introduce a specimen to the Analyzer.
Closed Mode
Sampling is performed by using the sample loader module which is attached to the
front of the analyzer. The sample loader module enables the operator to load up to
50 closed-tube samples at one setting, minimizing contact with patient specimens.
Sample loader components read the rack number and tube position bar codes, mix
the blood, and move the tubes through the Sample Processing area. These
components are described later in this section.
Sample loader barcode also reads the tube specimen barcode ID, if present.
Open Tube Mode
The Analyzer aspirates the specimen from an open collection tube presented by the
Operator. Open Tube Mode sampling supports the Reticulocyte parameters. See
Section 12: Reticulocyte Package for details.
Specimen Identification and Test Selection

Each specimen is identified by a unique time- and date-stamped sequence number
and can be identified by a specimen identification number. The test selections can
be made automatically or manually. Detailed information about specimen
identification and test selection is included in Section 5: Operating Instructions,
Subsection: Specimen Identification Methods.
In the Closed Mode, test selections created electronically from a Laboratory
Information System (LIS), or entered manually using the Create Order function
key in the Orders view, along with the bar code label, identify the specimen. The
CELL-DYN Ruby software uses the bar code labels and the Pending Orders log in
the Orders view to identify the specimen and tests requested. If there is no order in
the Pending Orders log, the system runs a default test selection which was
configured in Setup from the menu bar.
1-5
Use or Function
Section 1
In the Open Tube Mode, a specimen ID is manually entered, or the bar code label
is scanned in to the Next Open Tube Entry (NOTE) region. The
CELL-DYN Ruby software searches for a matching specimen ID in the Pending
Orders log of the Orders view. When a match is found, the software updates the
test selection in the NOTE region. See Section 5: Operating Instructions for
details about the Orders view and Pending Orders log.
NOTE: The system alerts the operator if a RETIC test selection is found when it
is not in the RETIC test mode. The system also alerts the operator if a
non-RETIC test selection is found and the system is in the RETIC
processing mode.
In Open Tube Mode, the Hand-Held Bar Code Reader can be used to identify the
specimen; or, the operator can visually identify the specimen, enter the patient
information, and select the test in the Next Open Tube Entry (NOTE) region. If
the Specimen ID entered into the Specimen ID field in the NOTE region exists in
the Pending Orders log, the specimen demographics will be placed into the
NOTE (detailed) view.
Specimen identification, patient information, and test selection results appear in
several places:
Datalog
Run View
After sample aspiration, the patient information can be edited in the Datalog view
by selecting the sample record in the Datalog and the F4Edit function key. The
function keys opens the Edit Demographic Information dialog box. Edits are
automatically recorded to the System Event Log.
See also Section 5: Operating Instructions, Subsection: Post-Analysis
Processing Datalog View and Section 9: Service and Maintenance,
Subsection: Event Log.
Test Selections
The CELL-DYN Ruby test selections are described in the following table:
Test Selection Printed
or Displayed
1-6
Test Selection Description
CBC
Complete Blood Count
CBC + NOC
Complete Blood Count with Nuclear Optical Count
CBC + RRBC
Complete Blood Count with Resistant RBC
RETIC
Reticulocyte
Section 1
Use or Function
System Components
The CELL-DYN Ruby System consists of these major modules: the Analyzer, the
Data Module (computer), and the flat panel Display. The Analyzer and the Data
Module are housed in a single chassis. The Display is a standalone module.
The Analyzer contains the hardware to mix, present, aspirate, dilute, and analyze
each specimen.
The Data Module contains the components for analyzing, storing, and reporting
specimen results.
The flat panel Display includes touch screen capability to enhance user interface
interaction.
Analyzer
The Analyzer does the following:
Identifies specimen
Mixes and presents each specimen for aspiration
Aspirates and dilutes the blood sample
Transports and analyzes the sample dilutions
Rinses fluidic components in preparation for the next sample dilutions
The following are key parts of the Analyzer:
Analyzer Front
Covers
Status Indicator Lights
Open Tube Mode Touch Plate
Open Tube Mode Aspiration Probe (Open Mode Probe)
Analyzer Right Side
CD-ROM or DVD Drive
Floppy Disk Drive
Data Station Power Button
Intake Fan and Filter
Analyzer Left Side
Intake Fan and Filter
1-7
Use or Function
Section 1
System Components
Analyzer Sample Processing

Sample Loader
Mixing Assembly
Sample Processing Area
Analyzer Flow Panels
Left Flow Panel
Right Flow Panel
Analyzer Internal Assemblies
Optical Bench Assembly
Analyzer Rear
Main Power Switch
Main Power Connector
Exhaust Fans
Reagent Inlet Connectors
Waste Sensor Jack
Waste Outlet Connector
Data Module (Computer) Cable and Port Connectors
Analyzer Front
Covers
A set of front covers encloses and protects the Analyzer mechanisms and flow
panel. These covers are designed to be opened for inspection and maintenance
procedures. The covers should always be in place during System operation. The
covers for the Analyzer are as follows:
Left Flow Panel Cover
Right Flow Panel Cover
Processor Cover
Left Flow Panel Cover
The Left Flow Panel Cover on the front of the Analyzer provides access to the Left
Flow Panel. The cover is held in place by hinges (located on the inside left edge of
the cover) and magnetic fasteners (located on the inside top edge of the cover). The
cover opens from the center with finger grips located at the lower right of the cover.
1-8
Section 1
Use or Function
Right Flow Panel Cover

The Right Flow Panel Cover on the front of the Analyzer provides access to the
Right Flow Panel. The cover is held in place by hinges (located on the inside right
edge of the cover) and magnetic fasteners (located on the inside top edge of the
cover). The cover opens from the center with finger grips located at the lower left
of the cover.
Processor Cover
The Processor Cover is located in the middle of the front of the Analyzer and fits
over the Sample Processing Module, Mixing Assembly, and Shear Valve
Assembly. The Processor Cover is not intended to be removed by the operator
during routine operation. The Processor Cover is used to restrict access to the
Sample Processing Module on the sample loader during operation. A sensor detects
if the cover is removed during operation and will stop the loader and generate a
fault message. The operator must re-install the cover and clear the fault in order to
resume operation. The cover must be in place during initialization or else a fault
message is generated.
Status Indicator Light
Status Indicator Light Emitting Diodes (LEDs) are located on the front of the
Analyzer. The LEDs inform the operator of the current operating status of the
CELL-DYN Ruby. The following table lists the LEDs, their color, and an
explanation of their status indications.
Table 1.1
LED
Status Indicator LEDs

Color
Status Indication
READY
Green
The Analyzer is ready to run specimens.
BUSY
Yellow
The Analyzer is busy.
FAULT
Amber
The Analyzer is not ready to run specimens.

The Open Tube Mode Touch Plate is a spring-loaded touch plate located in the
center frame of the Sample Loader. The Touch Plate is used to start the run cycle
for the Open Tube mode only. Pressing the Touch Plate starts the aspiration for the
selected run cycle.
Open Tube Mode Aspiration Probe (Open Mode Probe)
The Open Tube Mode Aspiration Probe is used to aspirate the specimen from an
opened collection tube. During open sampling, the wash block moves down to the
end of the probe and returns to its up position at the conclusion of the specimen run.
When Select Closed is selected, the Wash Block moves down to the end of the
probe and remains down until the Select Open is again selected.
1-9
Use or Function
Section 1
System Components
Analyzer Right Side

1 CD-ROM or DVD
Drive
2 Floppy Drive
3 Data Station Power
Button
4 Main Power Switch
(Rear Panel)
5 Intake Fan
Figure 1.2
4
5
3
2
Analyzer Right Side
CD-ROM or DVD Drive

The CD-ROM or DVD Drive allows the installation of software and the online
operators manual, provides backup and restoration of laboratory setup data, and
database record storage to CD-R media.
Floppy Disk Drive
The Floppy Disk Drive accepts high-density (1.44 megabyte), 3-inch diskettes to
transfer quality control assay information to the Analyzer and download quality
control numerical result files for participants in the CELL-DYN eQC Program.
Data Station Power Button
The System Data Station Power Button turns on both the Data Module (computer)
and Analyzer Systems.
Intake Fan
The Intake Fan provides air flow through the Analyzer chassis.
1-10
Section 1
Use or Function
Analyzer Left Side

Intake Fan
The Intake Fan provides air flow through the Analyzer chassis.
1 Intake Fan
Figure 1.3
Analyzer Left Side
Analyzer Sample Processing Area

Sample Loader Components
The major components of the Sample Loader are depicted in the following figure.
1 Open Tube Mode
Aspiration Probe (with
Wash Block)
2 Open Tube Mode
Touch Plate
3 Y-Valve Assembly
4 Mixhead Assembly
5 Tube Sensor
Assembly
6 Bar Code Reader
7 Tube Spinner
Assembly
8 Closed Mode Needle
(with Wash Block)
9 Specimen Rack(s)
10 Sample Loader Load
Side
11 Sample Loader
Unload Side
Figure 1.4
1
8
10
7
11
6
5
4
Sample Loader Components
1-11
Use or Function
System Components
Section 1
Open Tube Mode Aspiration Probe (with Wash block)

The Open Tube Mode Aspiration Probe (Open Mode Probe) is utilized to aspirate
the patient specimen while in the open sampling mode. Vacuum is applied to the
aspiration probe to draw in the sample for analysis. A Wash Block is used to clean
the outside of the probe by moving up/down and rinsing with Diluent/Sheath
Reagent. The wash block covers the probe tip throughout the run cycle to rinse the
probe and sample line and retracts prior to the instrument returning to Ready
status. Waste is removed through the use of a vacuum source and is deposited into
a waste chamber.
The Touch Plate is utilized during open tube sampling and is pressed to activate an
open mode run cycle.
Y-Valve Assembly
The Y-Valve Assembly has a three-way valve with motor that switches between the
Open Mode Probe and the Closed Mode Needle for aspirating patient specimens.
Mixhead Assembly
The Mixhead Assembly consists of a double-tube holder directly attached to a
stepper motor. As the rack advances, the tube holder descends and grabs the tube.
The tube holder rotates at least 10 times in an inward motion of approximately 135
degrees. The double-tube configuration of the tube holder allows each tube to be
held and mixed twice in succession before it passes to the tube spinner assembly.
An air cylinder controls the up/down movement of the Mixhead Assembly.
Tube Sensor Assembly
The Tube Sensor Assembly senses the presence of a specimen tube at each
Mixhead Assembly mixing station.
Bar Code Reader
The Bar Code Reader is an LED type that can accommodate Code 39, Code 128,
CODABAR, Interleaved 2 of 5, and ISBT formats. The Bar Code Reader is located
on the center frame section of the Sample Loader. It reads the bar code on the tube
when the tube is at the aspiration station. The Bar Code Reader is also utilized to
read the bar code labels on sample racks to ensure proper rack movement and for
positive patient identification.
Tube Spinner Assembly
The Tube Spinner Assembly consists of a tube holder, motor, and belt. These
components are attached to the Closed Mode Needle drive mechanism, and they
move up and down in tandem with the needle. As the Tube Spinner Assembly and
needle descend together, the spinning tube holder centers and rotates the specimen
tube, allowing the Bar Code Reader to read the bar code on the sample tube. After
the bar code is read, the needle penetrates the rubber stopper and aspirates the
sample.
1-12
Section 1
Use or Function
Closed Mode Needle (Vent Needle with Wash Block)

The Closed Mode Needle is used to aspirate the patient specimen from a closed
collection tube and is used while in the Closed Mode. The needle consists of two
ports; one port for sample aspiration and the other for closed tube venting. During
operation, the needle pierces the collection tube stopper, vents the tube, aspirates
patient specimen and retracts for rinsing at the end of each cycle. Needle rinsing is
performed by the wash block that utilizes Diluent/Sheath Reagent. Waste is
removed through the use of a vacuum source and is deposited into a waste chamber.
Specimen Rack(s)
Each Sample Loader Specimen Rack is able to accommodate up to 10 tubes.
Specimen racks are labeled with rack number and tube position, using a 2-digit bar
code label.
Sample Loader Load Side
The Load Side accommodates from one to five racks with specimen tubes for
sample processing through the Sample Loader. Once all specimen racks have been
processed, a message alerts the user that the load side is empty.
Sample Loader Unload Side
The Unload Side receives one to five racks with specimen tubes after they have
been processed. When five racks enter the unload side, a message alerts the user
that the unload side is full.
Sample Processing Module
The Sample Processing Module is attached to the Sample Loader and contains
components used for Closed Mode tube sampling. The Processor Cover previously
described is used to restrict user access to the Sample Processing Module area
during operation.
The Sample Processing Module consists of the following components:
Closed Mode Needle (Aspiration/Vent)
Wash Block
Mixhead Assembly
Y-Valve Assembly
1-13
Use or Function
Section 1
System Components
Analyzer Flow Panels

Right and Left Flow Panels
The major components of the Right and Left Flow Panels are depicted in
Figure 1.5. A brief description of Flow Panel components follows.
1 Vent Chamber
2 Sample Transfer
Peristaltic Pump
3 Waste Chambers
4 WBC Mixing
Chamber/WOC
Heater
5 RBC/PLT Mixing
Chamber
6 HGB Flow Cell/Mixing
Assembly
7 Shear Valve Assembly
8 Normally Closed
Valves
9 Diluent Reservoir
10 Sheath Reservoir
11 Normally Closed
Valves
12 Diluent/Sheath Filter
13 Sample Injection
Syringe
14 HGB Lyse Syringe
15 WBC Lyse Syringe
16 Diluent/Sheath
Syringe
17 Waste Chambers
18 WBC Lyse Reservoir
19 HGB Heater Assembly
20 Solenoid Valves
(example)
Figure 1.5
11
10

exposure to beam.
3
.
.
19
PN 9230701F
20
8
2
4
18
1
12
3
13 14 15 16
17
Flow Panel Components
Vent Chamber
The Vent Chamber allows various components such as the WBC, RBC and HGB
Mixing Chambers to equalize to atmospheric pressure for effective function.
1-14
Section 1
Use or Function
Sample Transfer Peristaltic Pump

The Sample Transfer Peristaltic Pump is composed of a rotor and a pump tube
holder. It is used to transfer the WBC dilution, RBC/PLT dilution, and HGB/NOC
dilution to the Optical Flow Cell from their respective mixing chambers.
Waste Chambers
The Waste Chambers collect the liquid waste from the Analyzer flow panel.
WBC Mixing Chamber/WOC Heater
The combination of a WOC heater and mixing chamber allows the WBC Lyse
Reagent to be controlled at room temperature prior to being delivered to the mixing
chamber. Pressurized air (bubble mix) is use to mix the sample and reagent being
delivered to the mixing chamber. The dilution is then delivered to the Optical Flow
Cell for processing.
RBC/PLT Mixing Chamber
The RBC/PLT Mixing Chamber utilizes pressurized air (bubble mix) to mix the
sample and reagent being delivered to the mixing chamber. The dilution is then
delivered to the Optical Flow Cell for processing.
HGB Flow Cell and Mixing Chamber
The HGB Flow Cell Assembly is integrated with a mixing chamber and contains
the following components:
A fully enclosed (light-tight) mixing chamber with optical windows and
electronics
An LED Light Source
A Photodetector for measuring the light transmitted
HGB Heater Assembly
The HGB Heater Assembly pre-heats the diluent for HGB and HGB/NOC Lyse
prior to dispensing into the HGB Mixing Chamber. The reagent is heated above
room temperature to ensure a consistent reaction temperature for HGB.
Shear Valve Assembly
The three-piece ceramic Shear Valve isolates a precise volume of sample by means
of a shearing action as the front and rear sections of the valve rotate. The aspirated
sample is isolated in three separate volume segments one for the WBC dilution,
one for the HGB dilution and one for the RBC/PLT dilution. Sensors located before
and after the shear valve control sample being aspirated into the probe and being
transferred into the shear valve. In both Open and Closed modes an ultrasonic
sensor checks the segment movement as it is being aspirated. Additionally, in the
Closed mode, an additional optical sensor checks the segment as it exits the shear
valve.
1-15
Use or Function
System Components
Section 1
Normally Closed Valves

The Normally Closed Valves remain closed even after the power to the instrument
is turned off to prevent the backflow of reagents into critical areas.
Diluent Reservoir
The Diluent Reservoir maintains a Diluent/Sheath Reagent supply for cleaning
and sample dilution.
Sheath Reservoir
The Sheath Reservoir maintains a Diluent/Sheath Reagent supply, separate from
that of the Diluent Reservoir, for hydrodynamic focusing of the sample cell stream
through the Flow Cell.
Diluent/Sheath Filter
The Diluent/Sheath Filter is placed in-line between the Sheath Reservoir and
Optical Flow Cell, as well as the Sample Injection Syringe, to eliminate micro
bubbles.
Syringe Assembly
There are two syringe driver assemblies, each containing two syringes. Each
syringe is operated by its own stepper motor. The function of each syringe is
described below:
Sample Injection Syringe injects a specific volume of the diluted sample
into the Optical Flow Cell for RBC/PLT, WBC (WOC), and WBC (NOC)
measurements.
HGB Lyse Syringe delivers a specific volume of HGB Lyse to the HGB
Mixing Chamber/Flow Cell to further dilute the HGB segment prior to
measurement.
WBC Lyse Syringe delivers a specific volume of WBC Lyse to transport
the WBC segment from the Shear Valve to the WBC Mixing Chamber,
dilutes the segment prior to measurement and a specific volume of WBC
Lyse is delivered to rinse the WBC Mixing Chamber.
NOTE: The WBC Lyse Syringe does not deliver the rinsing solution. The
rinsing solution is delivered by pressure from the WBC Lyse
reservoir.
Diluent/Sheath Syringe (1) delivers a specific volume of Diluent/Sheath
to transport the RBC segment from the Shear Valve to the RBC/PLT Mixing
Chamber and to dilute the segment prior to measurement, and (2) delivers a
specific volume of diluent to transport the HGB segment from the Shear
Valve to the HGB Mixing Chamber and to dilute the segment prior to
measurement.
1-16
Section 1
Use or Function
Solenoid Valves
The Solenoid Valves are used throughout the entire instrument, but particularly on
the Front Flow Panel. They are used to control air and liquid movement during
instrument operation.
WBC Lyse Reservoir
The WBC Lyse Reservoir maintains a WBC Lyse Reagent supply that is used to
dilute the sample that is presented to the Optical Flow Cell Assembly. The reagent
is also used to flush and clean the WBC Mixing Chamber prior to the next run
cycle.
Analyzer Internal Assemblies

Optical Bench Assembly
Description and illustrations of the Optical Bench Assembly are provided for
information purposes only. Access to this area is restricted to authorized Abbott
Service and Support Personnel only.
Laser Optics Assembly
The laser tube, a Helium-Neon gas laser, projects a beam that is shaped and
focused onto the Optical Flow Cell Assembly for detection and measurement
of blood cells.
A series of optical mirrors and lenses are used to shape and focus the beam
onto the Optical Flow Cell Assembly.
The Forward Angle Light Scatter Detectors are used to capture scattered light
in the 0 and 10 forward angles for count and measurement purposes.
The Orthogonal Light Scatter Detectors are used to capture scattered light in
the 90 and 90 Depolarized angles for measurement purposes. Compiled
orthogonal and forward light scattered data is used to generate WBC count/
differential, RBC/PLT counts including MCV, NOC counts and Reticulocyte
results.
1-17
Use or Function
Section 1
System Components
1 Optical Flow Cell

Assembly
2 Laser Tube
3 Laser Beam Shaping
Components (e.g.
Mirrors, Lenses and
Slits)
4 Forward Angle
(0 and 10) Light
Scatter Detectors
5 Orthogonal
(90 and 90D) Light
Scatter Detectors
4
3
Figure 1.6
Optical Bench
Optical Flow Cell Assembly

The Optical Flow Cell Assembly contains the fluidics and hardware needed
to hydrodynamically focus the RBC/PLT, WBC, and NOC sample streams in
the path of the laser beam for analysis. The primary components of this
assembly are:
Sample Feed Nozzle a specially designed tube used to deliver the diluted
sample into the sheath stream
Sample Flow Cell an optically clear quartz chamber with a central square
opening of a specific size, which flares out into a cone at the bottom of the
flow cell
1-18
Section 1
Use or Function
Analyzer Rear
1 Main Power Switch
2 Main Power
Connector
3 Exhaust Fans
4 WBC Lyse Reagent
Inlet Connector
5 Diluent/Sheath
Reagent Inlet
Connector
6 HGB Lyse Reagent
Inlet Connector
7 Waste Outlet
Connector
8 Waste Sensor Jack
9 Data Module
(Computer)
10 CPU Exhaust Fan
Figure 1.7
10
7 6 5 4
9
3
Analyzer Rear
Main Power Switch

The Main Power Switch is labeled POWER . Refer to the previous figure for
location.
Main Power Connector
The Main Power Connector connects the Analyzer to an external power source.
Exhaust Fans
The Exhaust Fans provide air flow through the analyzer chassis.
These connectors attach the tubing from the reagent containers to the Analyzer.
The container end of each piece of tubing has a cap, sinker, and label. The
following color-coded connectors are located on the Analyzer:
WBC Lyse Reagent Inlet Connector
Diluent/Sheath Reagent Inlet Connector
Hemoglobin Reagent Inlet Connector
1-19
Use or Function
Section 1
System Components
Table 1.2
Label Reference
WBC LYSE
DILUENT/SHEATH
HGB
Reagent Inlet Connector
Connector Color
WBC Lyse Reagent

Inlet Connector
Purple
Diluent/Sheath Reagent
Inlet Connector
Red
Hemoglobin Reagent Inlet

Connector
Blue
WBC Lyse Reagent Inlet Connector

The WBC Lyse Reagent Inlet Connector (color-coded purple) attaches the WBC
Lyse Reagent inlet tubing to the Analyzer.
Diluent/Sheath Reagent Inlet Connector
The Diluent/Sheath Reagent Inlet Connector (color-coded red) attaches the
Diluent/Sheath Reagent inlet tubing to the Analyzer.
Hemoglobin Reagent Inlet Connector
The Hemoglobin Reagent Inlet Connector (color-coded blue) attaches the
Hemoglobin Reagent inlet tubing to the Analyzer.
Ground Connector
See Waste Sensor Jack.
Waste Outlet Connector
The Analyzer Waste Outlet Connector, labeled WASTE OUTLET , attaches the
Analyzer waste tubing to the Analyzer. The Analyzer waste tubing evacuates the
liquid waste from the Analyzer to an external waste container or drain. See
previous figure.
1-20
Section 1
Use or Function
Waste Sensor Jack

The Waste Sensor Jack, labeled WASTE SENSOR , accepts the Waste Sensor Plug
that connects the Waste Sensor Electrodes to the electrical Waste Sensor in the
Analyzer. A disconnected Waste Sensor Plug will be interpreted by the System as
an external Waste Full message and the Ready state is inhibited until the situation
is corrected. The ground shield on the cable should be attached to the Ground
Connector on the rear panel. If waste is routed directly to a drain rather than to a
waste container, a dummy plug (supplied in the Accessory Kit) must be inserted
into the Waste Sensor Jack.
Data Module (Computer) - Cable and Port Connectors
See the following Subsection: Data Module Components for a description of the
components of the Data Module and associated cable and port connections used
with the CELL-DYN Ruby.
1-21
Use or Function
Section 1
System Components
Data Module Components

The major hardware component cable and port connections are depicted within this
section. A description of each component's function follows.
1
7
3
1
3
2 4
1 Printer
2 Mouse
3 Hand-Held Bar Code Reader
or Keyboard
Figure 1.8
4 Flat Panel Display

5 Touch Screen Interface to Data
Module
6 Analyzer Power Cord

7 Printer Power Cord
8 Monitor Power Cord
Hardware Component Cable and Connection Overview - Rear View
Data Module Computer

High-speed Microprocessor 2.0GHz or faster
RAM: 512MB or larger
Hard Disk 5.1GB or larger
1 parallel port
1 serial port
4 USB Ports
Video and Sound card
1-22
Section 1
Use or Function
1 HSSL (2)
2 Printer LPT1 (Parallel
Port Not Used)
3 LIS (Serial Port
COM1)
4 Flat Panel Display
5 Keyboard/Hand-Held
Bar Code Reader
6 USB (2) Touch Screen
& Printer
7 RJ-45 Network
(Reserved)
8 USB (2) Mouse and
Spare
9 Line Out (For Display
Speaker)
10 Line In (Not Used)
11 MIC (Microphone
Not Used)
Figure 1.9
1
2
8
3
9 10 11
4 5 6
Data Module Computer Component Connections - Rear View
HSSL (High Speed Serial Link) Connectors

The High Speed Serial Link transfers data between the Analyzer and the Data
Module. The HSSL Connector on the Data Module connects to the HSSL
Connector on the back panel of the Analyzer rear panel.
Graphics Printer (Parallel) Connector (Not Used)
This connector allows printers with parallel connections to interface to the system.
LIS (Laboratory Information System) Connector
LIS serial port is used to connect the Laboratory Information System to the Data
Module.
Flat Panel Display Connector
The Flat Panel Display Connector allows connection of the Flat Panel Display to
the Data Module Computer.
PC Keyboard/Hand-Held Bar Code Reader Connector
This port allows connection of a standard PC Keyboard. It can also accommodate
the hand-held bar code reader by using a specialized connector (included with the
unit) to attach to the PC Keyboard connection.
Universal Serial Bus (USB) Port(s)
These ports allow connection of the mouse, touch screen and USB compatible
printers.
1-23
Use or Function
Section 1
System Components
RJ-45 Network Connector

This port allows System Interface to Laboratory Network Systems.
Line Out Connector
This connector allows connection of the Flat Panel Display speakers to the Data
Module Computer.
Flat Panel Display with Touch Screen

The Flat Panel Display provides a high-resolution graphical interface with an additional feature of touch screen capability for navigation through the
CELL-DYN Ruby application software. The Display switches automatically
between 100 and 240 volts.
The following are on the right hand side of the Flat Panel Display (see attached figure):
User Controls
Figure 1.10 Flat Panel Display (Right Side)
Adjustment Buttons control the Display

ON/OFF Switch powers up and powers down the Display
The following are on the rear of the Flat Panel Display (see attached figure):
Connections on Underside
CONNECTIONS ON UNDERSIDE
POWER
Power
Cable
Display
Cable
USB
Touchscreen
Cable
Figure 1.11 Flat Panel Display (Back Side)
Power Cable connects the Display to an external power source

NOTE: Use a cable that is approved for this application.
1-24
Section 1
Use or Function
Display Cable connects the Display to the Data Module Computer

USB Touch Screen Cable connects the Display to the Data Module
Computer
Keyboard
The standard computer keyboard provides complete input functionality. It contains
a complete set of alphanumeric keys that can be used for data entry. The keyboard
connects to the rear panel of the computer. Certain keys have special uses
dependent on the area or dialog screen that is active. The following figure depicts
an example of an abbreviated standard keyboard used with the CELL-DYN Ruby.
The following table lists these keys and their functions.
Figure 1.12 Example of Standard English Keyboard
1-25
Use or Function
Section 1
System Components
Table 1.3
Keyboard Keys and Their Functions on the CELL-DYN Ruby

Press:
To:
Numeric keys (above

keyboard letter keys)
Enter data in fields.
Numeric keypad keys

(calculator arrangement
of keys at right of
keyboard)
Enter data in fields.
Enter
Accept data typed in a specific field and move cursor to next field (windows with
text entry fields).
[~]
Tilde character associated with Quality Control bar code IDs.
Tab
Move cursor to beginning of next field (left to right, top to bottom).
Shift + Tab
Move cursor to previous field (right to left, bottom to top).
Shift + Left Mouse Click
Highlight a range of selected records in a log view.
Ctrl + Left Mouse Click
Highlight selected individual records in a log view.
Insert
Toggle between inserting and overwriting text.
Backspace
Remove characters to left of cursor.
Delete
Remove characters to right of cursor.
Print Scrn
Print the displayed screen view.
Num Lock
Activate the numeric keypad area on the keyboard used to type numbers.
Esc
Reset unresponsive mouse actions when attempting to select buttons or text.
Ctrl + Alt + Delete
Display the Windows Task Manager dialog.
Alt + Tab
Display a dialog that allows the Operator to tab between the open applications,
making the tabbed-to application the active window.
1-26
Section 1
Use or Function
Mouse Input Device

A mouse input device is provided with the CELL-DYN Ruby System. The mouse
can move the cursor to select buttons and text, and turn options ON and OFF. The
following table describes how to use the mouse.
Mouse
Figure 1.13 Using the Mouse Input Device

Table 1.4
Mouse Actions
Task
Mouse Action
Move cursor
Move mouse on flat surface to change cursor

position on screen.
Select buttons or text
1. Position cursor on button or text.

2. Click (quickly press and release) left mouse
button.
Open drop down menu in

a view
1. Position cursor in a view.

2. Click (quickly press and release) right mouse
button.
NOTE: When dialog boxes used for text entry are opened, the mouse can be used
to move the text cursor to the left most area of the desired field by clicking
in it before attempting to type any characters.
1-27
Use or Function
Section 1
System Components
Hand-Held Bar Code Reader

The Hand-Held Bar Code Reader uses an LED light and can read and interpret any
bar code that meets the specifications described in Section 4: Performance
Characteristics and Specifications, Subsection: Bar Code Specifications.
The hand-held reader can be used to rapidly input the Quality Control specimen bar
code identification number into the NEXT OPEN TUBE ENTRY (NOTE) region
and enter reagent lot numbers and expiration dates into the New Reagent Entry
dialog box.
The Hand-Held Bar Code Reader must also be set up to indicate whether a check
character is used with the different supported bar code symbologies. This
customization is done within the unit itself, not from the CELL-DYN Ruby
software. For complete instructions, see the Hand-Held Bar Code Reader Users
Guide.
NOTE: The Hand-Held Bar Code Reader is connected in series to the keyboard
(see the following figure) and must be properly installed and programmed
before being used with the CELL-DYN Ruby. See the Hand-Held Bar
Code Reader Users Guide for complete information.
NOTE: Do not leave the Caps Lock key on the keyboard when using the
Hand-Held Bar Code Reader.
1 Keyboard
2 Hand-Held Bar Code
Reader
Figure 1.14 Hand-Held Bar Code Reader Connection.
1-28
Section 1
Use or Function
Printers
Printers available for use with the CELL-DYN Ruby include a standard color
printer (parallel or USB connector) or an optional color laser printer (USB
connector).
Results can be automatically printed at the completion of each run cycle or can be
printed on demand by the operator. Graphics reports are printed in color.
Complete information about printer capabilities and requirements can be found in
the printer manufacturers printer manuals. Descriptions of printer components,
safety precautions, running self-test printouts, types of replacement toner and
cartridges, and instructions on changing cartridges and loading paper are included
in the printer manual. Do not use printer cables longer than 10 feet (three meters).
Instructions for customizing the printout format and report headings are included
in Section 2: Installation Procedures and Special Requirements, Subsection:
Customize Printed Report.
CAUTION: Use of a non-Abbott-recommended printer must be validated
by your laboratory for use as it may lead to erroneous printer functionality.
Contact your Country Service and Support Center for information on printer
compatibility. Refer to Appendix A: Parts and Accessories for component
List Numbers.
The CELL-DYN Ruby software automatically controls and adjusts most print
conditions, including page width and color. It is recommended to select File, Print
Preview from the menu bar prior to selecting the F1 Print from the views. The
System will notify the operator if the layout of the view displayed spreads over one
page.
NOTE: Based on the printer manufacturer's color mapping software, you may
experience variations within the spectrum of color specified to print by
the CELL-DYN Ruby software.
Table 1.5
Printing Options
Graphics Printing
Printer Port
Connection Type
USB
Parallel
Report Forms
Single copy
Single copy
Paper Feed
Single sheet
Single sheet
Paper Size
US letter, A4
US letter, A4
Ink
Color
Color
Header
Up to four lines
Up to four lines
1-29
Use or Function
Section 1
System Components
NOTES
1-30
Section 1
Use or Function
System Software
The CELL-DYN Ruby contains the following sets of software:
Analyzer Operating Software
Data Station Operating Software
Analyzer Operating Software

The Analyzer Operating Software (AOS) controls the fluidic and mechanical
operation of the Analyzer, monitors System functioning, and provides the
framework for the flow sequences. The AOS is downloaded from the Data Module
to the Analyzer each time the System Computer is initialized.
Data Station Operating Software

The Data Station Operating Software (DSOS) supports the operator interface,
communicates with the AOS to initiate tasks and obtain measurement results, and
manages the processing, storage, and output of measurement results.
CELL-DYN Ruby software performs a confirmation of numerical entries in data
entry fields. This confirmation is performed as the operator enters text in fields or
when the OK button is selected in the active dialog box. The software matches the
entered date and time with established format, and checks that integers and
decimals entered are within specified ranges and that there are no invalid
characters. A message bulletin line of text will display at the bottom of the dialog
box indicating the field or fields where the invalid entry occurred. Examples
include:
Specimen ID name must include between 3 and 20 non-space characters
Westgard Rules are disabled until limits represent 2 or 3 standard deviations
No records found by the specified match criteria
1-31
Use or Function
Section 1
System Software
Screen Navigation
Screen Layout
These are the main sections as shown in Figure 1.15.
SYSTEM
MESSAGES
REGION
REGION
Figure 1.15 Screen Layout
The main sections are:

Title Bar
Menu Bar
Tool Bar
Status Bar and System Messages Region
NOTE Region
View
Function Keys
1-32
Section 1
Use or Function
Title Bar
Figure 1.16 Title Bar Example
The purpose of the Title bar is to identify the main view being displayed. The Title
bar also displays the CELL-DYN Rubys last run datalog sequence number and the
current date and time.
Menu Bar
Figure 1.17 Menu Bar Example
The Menu bar contains the menu command items available in CELL-DYN Ruby
software. To display the CELL-DYN Ruby menu commands, open each menu item
on the Menu bar using a single mouse click. Scroll down the menu list using the
mouse cursor and single click on the command item to open the menu command
dialog box.
NOTE: Options may be greyed out (inactive) based on user access level or
analyzer status.
Table 1.6
Menu Bar Commands
Menu Bar Item
Menu Commands
File
1-33
Use or Function
Section 1
System Software
Table 1.6
Menu Bar Commands (Continued)
Setup
Calibration
Diagnostics
Help
Sign Off
1-34
Section 1
Use or Function
Tool Bar
Figure 1.18 Tool Bar Buttons
The Tool Bar Buttons control the display of the Main View and the associated
Function Keys. To change the Main View, single mouse click on each tool bar
button. The identity of the main view is displayed in the Title bar of the screen
layout. Refer to Figure 1.15 Screen Layout.
Table 1.7
Tool Bar Button Navigation
Tool Bar Buttons

and Icons
Display Change and

Associated Function
Keys
Main View Description
Displayed Function Keys
Run View Displays

Specimen view of last run
sequence number
F1-Print
None
Orders Displays
Pending Orders
F1-Print
None
F3-Find/Filter
F4-Edit
F6-Create Order
Datalog Displays
System Data Log
F1-Print
None
F2-Transmit
F3-Find/Filter
F4-Edit
F7-View Specimen
F6-Create Order
F7-Previous Specimen
F8-Next Specimen
1-35
Use or Function
Section 1
System Software
Table 1.7
Tool Bar Button Navigation (Continued)

QC View Displays
QC Log
F1-Print
None
F2-Transmit
F3-Find/Filter
F4-Edit
F5-Moving Average
F6-Selected Batch Data

F7-Current Batch Data
F8-Levey Jennings
F7-View QC Spec
F8-Next Specimen
F8-QCID L-J Plot
F5-Download QCID
Data
F6-View QC Setup
F8-QCID Data
F5-Reject/Accept
F6-View QC Setup
F7-View QC Spec
F6-QCID Data
F7-Previous
Specimen
F8-Next
Specimen
1-36
Section 1
Table 1.7
Use or Function
Tool Bar Button Navigation (Continued)

Groups Displays
FWBC Group
NRBC/RRBC Group
Exceptions
Not Transmitted Group
F1-Print
None
F2-Transmit
F3-Find/Filter
F4-Edit
F5-Delete All
F6-Create Order
F7-View Specimen
F8-Next Specimen
Reagents Displays
Current Reagent Status,
Reagent Log
F1-Print
None
F3-Find/Filter
F4-Edit
F6-New Entry
Maintenance Displays
Scheduled, As-Needed,
Special Protocols,
Maintenance Log
F1-Print
None
F3-Find/Filter
F4-Edit
System Displays Event

Log, Calibration Log, Set
Point Log
F1-Print
None
F3-Find/Filter
1-37
Use or Function
Section 1
System Software
Status Bar and System Messages Region

The Status bar consists of four function keys and three distinct regions:
Analyzer Status
QC Status
System Messages
Status Bar Function Keys
Figure 1.19 Status Bar
1-38
Section 1
Use or Function
Analyzer Status Region

Provides the System status for:
Analyzer Operating States
Standby, Initialized, Priming, Ready, Maintenance
System Sampling Mode
Open or Closed
System Status Bulletin Messaging
Aspirating
Remove Specimen
Dispensing
Counting
Rinsing
QC Status Region
Provides on-line Quality Control monitoring status for:
Westgard Rule Alert IN/OUT Status
Moving Average Program IN/OUT Status
System Messages
Displays up to seven system messages at a time, generated from System events
such as warnings, conditions, and failures. When the mouse pointer is paused over
any System message containing an ellipsis () in the System Messages region, a
pop-up tool tip display appears containing the complete system message text
description. See also Section 10: Troubleshooting and Diagnostics,
Subsection: System Messages. See also Section 2: Installation Procedures and
Special Requirements, Subsection: User Interface Preferences for more
information on increasing or decreasing the display delay time for the pop-up tool
tips.
Figure 1.20 System Messages Region Example
1-39
Use or Function
Section 1
System Software

Table 1.8
Displayed Function Key
Provides Access to:
F9 Printer Status
Open the Printer Status window
F10 LIS
Open the LIS Setup window
F11 Mode Status
Select Open or Closed
F12 Loader Control
Select Start or Stop Loader
NOTE: If Status Bar Function Keys become unresponsive, use mouse or touch
screen to access the respective functions via the Status Bar (see
Figure 1.19).
NOTE Region (Next Open Tube Entry)

The Next Open Tube Entry region displays the operator entered Specimen ID or
(QCID), Specimen Type, and Test Selection for the next specimen to be sampled
in the Open Tube Mode. Next Open Tube Entry demographic details can be added
for patient specimens by selecting the More Spec Info button. For Backgrounds,
QC and SRP specimen types, comments can be added by selecting the More Spec
Info button. Select the QCID icon to open the QCID Lookup window which
displays the list of QCID files.
NOTE: When using this icon, the list of QCID files associated with the
reticulocyte parameters can only be displayed when the System is ready
to run the Open Mode Reticulocyte Method, RETIC test selection.
Figure 1.21 NOTE Region
1-40
Section 1
Use or Function
Figure 1.22 NOTE Detailed (More Spec Info Window)
Figure 1.23 QCID Lookup Window
View
Depending on the view, the navigation possibilities will change. When there is
more than one page of information that can be displayed within a view, the operator
can touch or click on the tab to bring that page into the main view. See also
Section 2: Installation Procedures and Special Requirements,
Subsection: System Customization for details on customizing views.
1-41
Use or Function
Section 1
System Software
Table 1.9
Tab Descriptions
Tool Bar Buttons

and Icons
Main View
Description
Tab Descriptions
Run View Displays

Specimen view of last
run sequence number
Orders Displays
Pending Orders
Datalog Displays
System Data Log
QC View Displays
QC Log
Groups Displays
FWBC Group,
NRBC/RRBC Group,
Not Transmitted
Group
Reagents Displays
Current Reagent
Status, Reagent Log
Maintenance
Displays Scheduled,
As-Needed, Special
Protocols,
Maintenance Log
System Displays
Event Log, Calibration
Log, Set Point Log
Function Keys
Figure 1.24 Function Key Examples
The function keys can be selected by either touching the screen function key
button, pressing the associated F1 thru F12 function keys on the keyboard, or
clicking on each function key button. Available function keys appear, disappear,
and can change functions depending on the view displayed.
1-42
Section 1
Use or Function
CELL-DYN Ruby Reagents

CELL-DYN Ruby reagents are formulated for use on the CELL-DYN Ruby in
order to provide optimal system performance. Use of reagents other than those
specified in this manual is not recommended as system performance can be
affected. Each CELL-DYN Ruby is tested at the factory using the specified
reagents and all performance claims are generated using these reagents.
The reagents used with the CELL-DYN Ruby are:
CELL-DYN Diluent/Sheath Reagent
CELL-DYN CN-Free HGB/NOC Lyse Reagent
CELL-DYN WBC Lyse Reagent
CELL-DYN Reticulocyte Reagent
Reagents must be stored at room temperature to ensure optimal performance. All
reagents should be protected from direct sunlight, extreme heat, and freezing
during shipment and storage. Temperatures below 32 F (0C) may cause reagent
layering that changes the tonicity and conductivity of the reagents.
CAUTION: If any reagent has been frozen, it must not be used.
The reagent inlet tubes have a cap attached that minimizes evaporation and
contamination during use. However, reagent quality may deteriorate with time.
Therefore, use all reagents within the dating period indicated on the label. For list
numbers of reagents, refer to Appendix A: Parts and Accessories, Table A.6.
CELL-DYN Diluent/Sheath
CELL-DYN Diluent/Sheath has the following major functions:
Maintain the stable diluted cell volume of each red cell and platelet during
the count and sizing portion of the measurement cycle
Serve as a sheath fluid for the hydrodynamic focusing process
Serve as a rinsing agent for the fluidics system
CELL-DYN CN-Free HGB/NOC Lyse

CELL-DYN CN-Free HGB/NOC Lyse is cyanide-free and has the following major
functions:
Rapidly lyse the red blood cells and minimize the resultant cellular debris
Strip the white cell cytoplasm leaving the nuclear membrane intact so the
white cell nuclei can be enumerated
1-43
Use or Function
Section 1
CELL-DYN Ruby Reagents
Convert hemoglobin to a stable chromagen complex that is measurable at

555 nm.
CELL-DYN WBC Lyse

CELL-DYN WBC Lyse has the following major functions:
Act as the diluent for the WBC
Osmotically lyse the red cells
Maintain the right scattering properties of the WBC for the duration of the
measurement period
Provide sufficient wetting action to prevent accumulation of air bubbles in
the WBC flow system
Serve as a rinsing agent for the WBC Mixing Chamber
Act as a diluent for Reticulocytes
CELL-DYN Reticulocyte Reagent

CELL-DYN Reticulocyte Reagent is formulated specifically to provide optimal
system performance for the CELL-DYN Ruby Reticulocyte procedure. Use of
reagents other than those specified in this manual is not recommended because
instrument performance can be affected. Each CELL-DYN Ruby System is
checked at the factory using the specified reagents and all performance claims were
generated using these reagents.
Reagent must be stored in the dark at room temperature. All reagents should be
protected from direct sunlight, extreme heat, and freezing during storage.
CAUTION: If any reagent has been frozen, it must not be used.
Reagent tubes have been capped to minimize evaporation. However, reagent

quality may deteriorate with time. Therefore, use all reagents within the dating
period indicated on the label.
See Section 12: Reticulocyte Package for Reticulocyte procedure details.
1-44
Section 1
Use or Function
Controls, Calibrator, and Standard Reference

Particles
Controls, Calibrator, and Standard Reference Particles (SRPs) are reference
materials used to test, set, and monitor CELL-DYN Ruby performance.
Controls
Day-to-day verification of System calibration is performed using CELL-DYN
Control products. The frequency of quality control runs should be determined by
each laboratory. This may be specified by the regulatory agencies governing the
laboratory. Quality Control is discussed in detail in Section 11: Quality Control.
For list numbers of control products, refer to Appendix A: Parts and Accessories.
Calibrators
Calibration of the directly measured parameters can be performed using
CELL-DYN calibrator products. Calibration is discussed in detail in
Section 6: Calibration Procedures.
For list numbers of calibrator products, see Appendix A: Parts and Accessories.
Standard Reference Particles

Standard Reference Particles (SRPs) are standardized materials intended for use by
field service and support representatives to verify and/or set electronic gain and
optical alignment. These reference materials are not intended for use by operators.
1-45
Use or Function
Controls, Calibrator, and Standard Reference Particles
Section 1
NOTES
1-46
Section 2 Installation Procedures and Special Requirements
Section 2
Overview
This section provides information about installation and customization of the
CELL-DYN Ruby. The beginning of this section provides the following
requirements and guidelines for installing the System:
Site requirements
Guidelines for unpacking and inspection, connection and start-up, and
relocation
NOTE: An authorized Abbott representative should install the
CELL-DYN Ruby. Installation of the CELL-DYN Ruby by an
unauthorized or untrained person could result in damage to the
System. Do not attempt to install the System without an authorized
Abbott representative present or the warranty could be voided.
The remainder of this section provides the procedures for customizing various
functions and features. These customization options include the following:
Setting up the operating conditions (for example, units displayed and the
default patient test selection)
Configuring data view displays and customizing printed reports
NOTE: Basic setup for Quality Control ID (QCID) Files is covered in
Section 11: Quality Control.
2-1

Section 2
Overview
NOTES
2-2
Section 2
Installation
This subsection provides the following requirements and guidelines for
installation:
Site Requirements
Unpacking and Inspection Guidelines
System Connection and Start-Up Guidelines
System Relocation and Shipping Guidelines
Site Requirements
Site requirements for installation cover the following topics:
Clearance Requirements
Power Requirements
Waste Disposal Requirements
Refer to Section 4: Performance Characteristics and Specifications for site
requirement details on physical, power, and environmental specifications.
Refer to Section 7: Operational Precautions and Limitations for general
requirements and precautions for System operation.
To ensure proper service access and ventilation, provide the CELL-DYN Ruby
with the Clearance Requirements specified in Section 4: Performance
Characteristics and Specifications, Table 4.4 and Table 4.5.
CAUTION: Do not position the CELL-DYN Ruby so that it is difficult to
operate the main power switch, located on the rear right of the Analyzer.
Power Requirements
The following are the power requirements:
A constant, non-fluctuating power source. Use of an AC line with dimmer
switches can cause electrical current fluctuations that could affect proper
functioning of the System, and therefore is not recommended.
Three outlets grounded to the same grounding wire. Separate grounding can
result in voltage differences that can create internal interference in the
system.
NOTE: For complete power specifications, refer to
Section 4: Performance Characteristics and Specifications.
2-3

Section 2
Installation

WARNING: Potential Biohazard. Observe all biosafety and chemical
hazard precautions for waste disposal. For a detailed description of the
hazards associated with the CELL-DYN Ruby, refer to Section 8: Hazards.
Observe the following requirements for waste routing and disposal:
Users are responsible for disposing of waste according to local, state, and
federal regulations.
If a waste container is used, it must be labeled as biohazardous waste.
If a waste container is used, verify that the Waste Sensor Plug (attached to the
Waste Container Caps electrode wires) is properly inserted into the
connector labeled Waste Sensor on the rear panel of the Analyzer.
If a drain is used, it must be suitable for waste that could present a biological
or chemical hazard.
WARNING: Potential Biohazard. The waste is under pressure. Be sure
that the Waste Outlet Tube is placed securely in the drain. To prevent a
possible hazard, ensure that all System components are located away from
potential waste overflow.
If a drain is used, insert the Dummy Plug provided in the Accessory Kit into
the Waste Sensor connector. Otherwise, the System will generate an incorrect
System Information Message, indicating Waste Full, and the System will
halt.
Unpacking and Inspection Guidelines

An Abbott representative uncrates, inspects, and moves the CELL-DYN Ruby to
the designated location in the laboratory.
The following reagents are required for installation:
CELL-DYN Diluent/Sheath Reagent
CELL-DYN WBC Lyse Reagent
CELL-DYN CN-Free HGB/NOC Lyse Reagent
Refer to Appendix A: Parts and Accessories for the list of calibrators and controls
available for installation.
All materials must be inspected upon receipt, and refrigerated if indicated. Refer to
the material manufacturers specific documentation (such as package insert and
labels) that are associated with these materials. If any reagents, calibrators, or
controls are missing, leaking, or damaged, contact your Country Service and
Support Center.
2-4
Section 2
System Connection and Start Up Guidelines

An authorized Abbott representative will perform all System setup, including
installation of the Analyzer, flat panel display, printer, and reagents, and ensure that
the System is operating within the manufacturers specifications. This person or
another Abbott representative will assist the customer in customizing the System.
If the CELL-DYN Ruby is ever moved, or if power, tubing, or cables are ever
disconnected for any reason, verify that the Analyzer, flat panel display, printer,
and all tubing and cables are properly reconnected. For illustrations of connectors
and cable locations for each module, refer to Section 1: Use or Function,
Figure 1.8 and Figure 1.9.
System Relocation and Shipping Guidelines

If the CELL-DYN Ruby must be relocated or shipped, contact your Country
Service and Support Center for directions for repackaging. The instrument must be
properly decontaminated before it is shipped, relocated, or serviced. For
procedures to decontaminate the System and prepare it for shipping, refer to
Section 9: Service and Maintenance, Subsection: Decontamination Procedures.
2-5

Section 2
Installation
NOTES
2-6
Section 2
System Customization
The CELL-DYN Ruby provides a high degree of flexibility in customization. This
subsection covers the various operating conditions and features that can be
customized, and provides procedures for customization. Once customization is
completed, frequent changes in settings should not be necessary.
System Customization is carried out through the Setup menu bar item.
Procedures for backing up and restoring the System customization and database is
also described in this section.
Customization and setup of Quality Control ID (QCID) Files is detailed in
Setup Menu
The Setup menu provides various menu options for customizing System operating
conditions.
The following table lists the Setup menu selections and summarizes the associated
features that are customizable.
Table 2.1
Customizable Menu Items

Setup Selection
Features That Can Be Customized
Patient Sample Setup...
Unit Sets Selection
Unit format selections

Unit format reset to factory defaults
Customize Run View
Chartable Page (up to 8 different parameter sets):

Parameter Set Name
Graphs and Parameters
Lab Page:
Graphs Page:
Graphs
All Run Views reset to factory defaults
Limit Set Name

Lower and upper limits for each parameter
Limits reset to factory defaults
Demographics label for User Field 1 and User Field 2
Default Patient Test Selection
2-7

Section 2
Table 2.1
Customizable Menu Items (Continued)
Customize Data View
Datalog, QC View, and Groups View:

Tab Title
Tab view column headings (Add/Remove)
Add Tab Page and Delete Tab Page
All Data Views reset to factory defaults
NOTE: Customization setup done in Datalog view will be
applied to the Groups view.
Customize Moving Average View
Moving Average View:

Tab view column heading (add/remove)
Tab view reset to factory defaults
See Section 11: Quality Control, Subsection:
Customize Moving Average View.
Customize Printed Report
Customize Report Header

Auto Print Chartable Page Report
Other Printed Report Options:
Graphs
Manual Differential Grids
Interpretive Report
Limits Report
QCID Setup
Control Data for Commercial and Whole Blood

QC Limits:
Update Means and Limits
Standard Deviations
Retrieve from file
Westgard Rule Setup
See Section 11: Quality Control, Subsection: QCID
File Setup.
Moving Average Acceptance Setup
Monitor Moving Average On/Off

Moving Average Groups:
Lower and Upper Limits
Target Values
Action Limits
Number of Batches to display in view
See Section 11: Quality Control, Subsection: Moving
Average Acceptance Setup.
2-8
Section 2
Table 2.1
Customizable Menu Items (Continued)
Administrative
Setup
Operators
Operator Accounts
Add, Remove, Edit
Operator ID, Password, Access level
Permission Access Rights for:
Laboratory I and II Levels
Second Sign On for all access levels
User Interface
Preferences
Instrument ID Setup
Analyzer Name
Bar Code Setup
Check digit setup for all symbologies enable/disable
Orders Setup
Automatic Orders Cleanup

Use rack and tube matching enable/disable
LIS Setup
QC Download ID File Setup
See Section 11: Quality Control, Subsection: QC

Download ID Setup.
Flag Setting
ATYPDEP: Off, Medium, High
Logs Auto Backup Setup...
Set time for automatic backup of database
Rule Setup...
Tool Tip Display Time

QCID Daily Cleanup
Date Format
Time Format
Set Date/Time and Time Zone
Auto Transmission
Manual Transmission
LIS Configuration
LIS Tests
Set up system to point and view text annotation based

on lab rules.
Patient Sample Setup...

Patient Sample Setup dialog box makes it possible to:
Customize Limit Sets
Change the demographic label for User Field 1 and User Field 2
Setup the Default Patient Test Selection
2-9

Section 2
Patient Sample Setup, Limits Tab View

Setup > Patient Sample Setup >
Limits tab
Limit Set: numbers 1 through
3; additional numbers created
Limit Set Name: Default,
Universal Male, Universal
Female, etc.
Default button returns ALL

Limit Sets to factory-set default
Cancel button
Print button print __________
<<Prev button - returns to previous page
OK button confirms changes
Next>> button: Bold white text indicates button is active
2-10
Section 2
Demographics Tab View
Customize Limit Sets

Patient Limit Sets contain specified
numerical lower and upper limits for each
parameter. The Limits tab view is used to
enter upper and lower flagging limits for
groups of patient samples. (For example,
limits may be entered for adult males,
adult females, neonates, etc.) The System
uses the selected Limit Set to determine
whether a result is in violation. Results
displayed in yellow-orange are below the
limit, results displayed in purple are above
the limit, and the flagged result is
underlined on the printed report.
Limit Set 1, 2, and 3 contain upper and
lower limits pre-set at the factory. The
Limit Set Name for 1, 2, and 3 can be
edited. If these Limit sets are changed, the
operator can return to the factory-set limits selecting the Default button.
NOTE: If the Limit Set Names are edited, Limit Set 2 will still be designated sex
as Male and Limit Set 3 will still be designated sex as Female.
The limit of available Limit Sets beyond Limit Set 3 are based on your laboratorys
setup using the following Subsection: Automatic Patient Limit Set Creation.
NOTE: Selecting the Default button deletes all Limits Sets created or customized
to the factory defaults.
2-11

Section 2
Table 2.2
Limit Set Default Descriptions
Limit Set
Number
Description
Comment
No age
No sex
(Default)
Assigned to any Patient without both an

age and a sex designation or whose age
and sex (if input) cannot be assigned by
the system to a specific Limit Set.
Universal Male
Assigned to any Patient with a designated

sex as male without an age or whose age
(if input) cannot be assigned by the system
to a specific Limit Set.
Universal Female
Assigned to any Patient with a designated

sex as female without an age or whose age
(if input) cannot be assigned by the system
to a specific Limit Set.
Dispersional Data Alerts

It is suggested that one Patient Limit Set be used to enter instrument-specific
laboratory action limits. If the Print Interpretive Report option is enabled in Setup,
Customize Printed Report, the Interpretive messages, such as leukocytosis,
anemia, thrombocytopenia, etc., will be displayed when a result falls outside the
appropriate limit. A result that falls outside a laboratory action limit can also
indicate the need for the operator to follow a laboratory protocol, such as repeating
the specimen, notifying the physician or performing a smear review. In cases where
a cellular abnormality is present that alters cellular morphology to the point that the
cells do not fit the criteria used by the instrument to generate a flag, dispersional
data alerts may be the only flag(s) that will alert the operator to a potentially
erroneous result.
2-12
Section 2
Automatic Patient Limit Set Creation

1. Select Setup from the menu bar, and Patient Sample Setup... from the pulldown menu. The Patient Sample Setup dialog box opens.
2. Select the Next>> button until a message box opens and displays the
message: No Auto Limit Sets; Create new one?
2-13

Section 2
3. Select Yes to create a new Limit Sets. (Selecting No closes the message box.)
The Patient Sample Setup dialog box now displays:
Field
Entry
Description
Limit Set:
The first three Limit Sets are default

settings, #4 is the first Limit Set that
can be customized
Limit Set
Name:
M(0,0-199,0)
Default name uses M=male and

F=female. Default age range is 0-199
years for easy identification
Sex:
Male
Automatic defaults as the sex to

customize first
Age Range:
From 0,0 To
199,0
X,X = years, weeks therefore

M(0,0-199,0) is 0 years, 0 weeks to
199 years, 0 weeks
the next available Limit Set Male with settings of age 0 to 199 years.
Newly created Limit Set #4

Limit Set Name is a descriptive name
Sex selection is automatic for first
created
Age Range fields
used to enter age
parameters
Once a Male limit set with an upper age range of 199 years has been created,
selecting the NEXT >> button automatically creates a Female limit set with
age range 0.0 to 199.0.
As the Male or Female related age ranges are updated, the system software
automatically calculates and creates the next Male or Female limit set age
range to 199 years.
2-14
Section 2
Additionally, when Limit Sets are altered, the software notifies the operator
that executing the change updates the Limit Set field in Pending Order entries
to AUTO. This causes the system to search for the appropriate Limit Set
based on sex and age range.
2-15

Section 2
Example of Limit Set Customization and Procedures

The following steps describe the default settings and how to create new Limit
Sets.
1. Select Setup from the menu bar, and Patient Sample Setup... from the pulldown menu. The Patient Sample Setup dialog box opens.
Field
Description
Limit
Set
1 (Use the pull-down

menu to view the
other Limit Sets
and their
respective data.)
Limit
Set
Name
Default
NOTE: Sex not
defined, no
field listed in
dialog box
The default age range is from 0

to 199 years and the sex is not
defined.
Default
199 years
0 days
2. Click the Next>> button to view the next Limit Sets and the respective data.
Field
Description
Limit
Set
Limit
Set
Name
Universal Male
Sex
Male; New field, Sex,

added to dialog box
Universal Male
0 days
2-16
199 years
Section 2
3. Click the Next>> button to view the next Limit Sets and the respective data.
Field
Description
Limit
Set
Limit
Set
Name
Universal Female
Sex
Female
Universal Female
199 years
0 days
4. Click Next>> and the Create New dialog box opens.
5. Select Yes and then the M(0,0 -199,0) Limit Set Name opens.
Field
Description
Limit
Set
Limit
Set
Name
M(0,0 -199,0) (A male

from age 0 to 199
years.)
Sex
Male
Age
Range:
From (0 Years) (0
Weeks) To (199
Years) (0 Weeks)
M(0,0-199,0)
0 days
199 years
2-17

Section 2
6. Setup a New Limit Set for a neonate male from age 0 week to 1 week by
entering the following data.
Field
Enter this data:
Limit
Set
4 automatically
entered
Limit
Set
Name
M(0,0 -0,1) (A male

from 0 weeks to 1
week)
Sex
Male
Age
Range:
From (0 Years) (0
Weeks) To (0 Years)
(1 Weeks)
and the System

automatically calculates the
Limit Set Name Field
M(0,0-0,1)
0 days - 1 week
Enter the age range here...
199 years
NOTE: The system automatically

creates the next limit set
using this age range and
naming it in the Limit Set
Name field.
M(0,1-199,0)
1 week
2-18
199 years
Section 2

7. Select the Next >> button and the next limit set is automatically calculated to
display the following data.
Field
Description:
Limit
Set
5 System
automatically
calculates and enters
the new Limit Set.
Limit
Set
Name
M(0,1 -199,0) (A male

from age 1 week to
199 years.)
Sex
Male
Age
Range:
From (0 Years) (1
Weeks) To (199
Years) (0 Weeks)
M(0,1-199,0)
1 week
199 years
8. Select the Next >> button and the Patient Sample Setup displays the
following information.
Field
Description
Limit
Set
6 automatically
entered
Limit
Set
Name
F(0,0 -199,0) (A
female from age 0 to
199 years.)
Sex
Female
Age
Range:
From (0 Years) (0
Weeks) To (199
Years) (0 Weeks)
F (0,0-199,0)
0 days
199 years
2-19

Section 2
9. Enter the following information to create a Limit Set for a neonate female
from age 0 week to 1 week old.
Field
Enter this data:
Limit
Set
6 automatically
entered
Limit
Set
Name
From (0 Years) (0
Weeks) To (0 Years)
(1 Weeks)
Sex
Female
Age
Range:
F(0,0 -0,1) (A female

from 0 weeks to 1
week)
F (0,0-0,1)
Enter the age range here...
and the System

automatically calculates the
Limit Set Name field
199 years
0 days - 1 week
NOTE: The system auto

creates the next limit
set with this age range.
F(0,1-199,0)
1 week
2-20
199 years
Section 2
10. Select the Next >> button and next limit set is automatically calculated to
display:
Field
Description
Limit
Set
7 automatically
entered
Limit
Set
Name
F(0,1 -199,0) (A
female from age 1
week to 199 years.)
Sex
Female
Age
Range:
From (0 Years) (1
Weeks) To (199
Years) (0 Weeks)
F (0,1-199,0)
1 week
199 years
11. Select the OK button to save the customization.

12. Using the Print button, print out each Limit Set, verify the lower and upper
limits entered, and review that the customization of sex and age range meets
the laboratorys expectations.
Demographic Tab View

To Change Demographic the User Field 1 & 2 Label
2-21

Section 2
Table 2.3
To Change the User Field

Task
Change User Field

Label
Step
Result/Comment
1. Select Setup from the menu bar, and

Patient Sample Setup from the
pull-down menu to open the Patient
Sample Setup dialog box.
2. Click on Demographics tab.
3. Type the text to update the label
name.
4. Select the OK button to save the
changes.
NOTE: The Custom Labels for User
Field 1 and User Field 2 must be
unique.
Default Patient Test Selection

Refer to Section 5: Operating Instructions, Subsection: Default Patient Test
Selection Processing Conditions for details of this setting.
Table 2.4
To Select the Default Patient Test Selection

Task
Step
Choose Default
Patient Test Selection
1. Select Setup from the menu bar, and

Patient Sample Setup from the
pull-down menu to open the Patient
Sample Setup dialog box.
2. Click on Demographics tab.
3. From the drop down list, select the
default processing test selection.
4. Select the OK button to save the
changes.
2-22
Result/Comment
Section 2
Unit Sets Selection

The units selected are displayed and printed along with the numerical results in
various views. You can select one reporting system to apply to all parameters, or,
you can mix and match the type of units for individual parameters.
NOTE: The CELL-DYN Ruby software transmits all numerical results in USA
units of measure. Refer to the document CELL-DYN Ruby Laboratory
Information System Interface Specification, an orderable item listed in
Appendix A: Parts and Accessories.
Unit Format Selections

Table 2.5
Procedure to Change the Unit Sets Selection

Tasks
Steps
Accessing the Unit

Sets Selection dialog
box
1. Select Setup and Unit Sets

Selection from the menu bar. The
Unit Sets Selection dialog box
opens.
Select one reporting

unit
1. Select the parameter units using one

of the following methods:
Choose a category USA, SI, SI
Mod, Set 1 or Set 2 by selecting
the button at the top of the column.
Choose a parameter unit one
per row by clicking the radio
button directly to the left of the unit.
2. Select OK which saves any changes
and closes the dialog box.
Result/Comments
Cancel button closes the dialog box

without retaining any changes.
Reset to factory
defaults
1. Select the Default which resets the

report units to the USA default
settings
2. Select OK.
2-23

Section 2
Customize Run View
Customize Run Data

Chartable Page
Graphs tab
Parameters tab
Customize Run Data
Lab Page
Graphs tab
Parameters tab
Customize Run Data

Graphs Page
Graphs tab
Using the
2-24
button resets all the Run View Parameter Set settings to the factory defaults.
Section 2
Sections:
Chartable Page
Lab Page
Graphs Page
NOTE: The Default button resets all the Run View parameter set setting to
factory defaults no matter which view you are in.
Chartable Page
Parameter Set Name
There are eight customizable parameter set views.
Table 2.6
Procedure to Customize Parameter Set - Chartable Page

Task
Steps
Access the
Customize Run View
Chartable Page View
1. Select Run View from the tool bar.

2. Select Setup and Customize Run
View from the menu bar. The
Customize Run View dialog box
opens.
3. Select the Chartable page from the
Select Page pull-down menu and the
Chartable page opens. The other
pages are Lab or Graphs.
4. Select the Parameter Set using the
pull-down menu in the Parameter Set
field.
5. Enter a Parameter Set Name in the
Parameter Set Name field.
Result/Comment
2-25

Section 2
Table 2.6
Procedure to Customize Parameter Set - Chartable Page (Continued)

Task
Customize Graphs
and Parameters for
the Parameter Set
2-26
Steps
Result/Comment
1. Select the Graphs tab view.

2. In the Available Graphs area, select
the Measurement Type from the pulldown menu: RBC, WBC, NOC.
3. To change which plots or histograms
are visible in the Run View:
a. To add plots or histograms to the
Selected Graphs column:
1. Select the item from the
Available Graphs.
2. Select the arrow pointing right
and the selected item moves to
the Selected Graphs column
and will display in the Run
View.
b. To remove items from the
Selected Graphs column so they
do not display in the Run View:
1. Select the item in the Selected
Graphs column.
2. Select the arrow point to the left
and the selected items returns
to the appropriate field.
4. The Graphs Layout region depicts
how the selected graphs will display in
the Run View.
5. Select the Parameters tab and the
Parameters view opens.
6. Select the checkbox of parameters to
display on the Run View.
7. Click OK to confirm all the changes.
NOTE: Clicking OK at an earlier stage
confirms the changes to that
point and closes the dialog box.
Only Click OK when all changes
are completed.
Section 2
Lab Page
This page is for laboratory use only.
Table 2.7
Customize the Run View - Lab Page

Task
Steps
Customize Run View

Lab Page View

opens.
3. Select the Lab page from the Select
Page pull-down menu and the Lab
page opens.
4. In the Available Graphs area, select
the Measurement Type from the pulldown menu: RBC, WBC, NOC.
Available Graphs.
View.
b. To remove items from the selected
Graphs column so they do not
display in the Run View:
Graphs column.
how the selected graphs will be
displayed in the Run View.
Result/Comment
2-27

Section 2
Table 2.7
Customize the Run View - Lab Page (Continued)

Task
Steps
Result/Comment
7. Select the Parameters tab and the

Parameters view opens.
8. Select the checkbox of parameters to
display on the Run View.
are completed.
2-28
Section 2
Graphs Page
Graphs
Table 2.8
Procedure to Customize the Run View - Graphs Page

Task
Steps
Access the
Customize Run View
Graphs Page View

opens.
3. Select the Graphs page from the
Select Page pull-down menu and the
Graphs page opens.
4. In the Available Graphs, select the
Measurement Type from the pulldown menu: RBC, WBC, NOC.
Available Graphs region.
View.
b. To remove items from the
Selected Graphs column so they
do not display in the Run View:
Graphs column.
how the selected graphs will be
displayed in the Run View.
are completed.
Result/Comment
2-29

Section 2
Customize Data View

Datalog, QC View, and Groups View
Allows customization of:
Tab Page Titles
Tab page column headings (Add/Remove)
Add Tab Page and Delete Tab Page
All Data Views reset to factory defaults
Customize Data View:
Is only active when the screen is in Datalog view or QC View.
Customization made in the Datalog view is applied to the Groups view.
Customize one data view tab page at a time.
NOTE: Using the Default button resets the tab page in the view to factory
default, thereby eliminating any customizations to the individual
tab pages.
2-30
Section 2
Table 2.9
Procedure to Customize Tab Titles and Column Headings in Data View

Task
Steps
Access the
Customize Data View
dialog box
1. Select Datalog or QC View from the

tool bar menu.
2. Select Setup and Customize Data
Customize Data View dialog box
opens.
3. To change the name of the Tab Page:
a. From the page field, select the tab
page name from the pull-down
menu.
b. Type in the new name
c. Select the OK button to accept the
changes.
4. To change the tab page column
headings:
a. From the page field, select the tab
page name from the pull-down
menu.
b. To remove a parameter from
Selected Columns:
1. Select the heading in the
column entitled Selected
Columns.
2. Select the arrow pointing to the
left and the item moves to the
left into the column entitled
Available Columns.
c. To add a heading to Selected
Columns:
1. Highlight the item being added
to the tab page from Available
Columns.
2. Select the arrow pointing to the
right and the item moves to the
right into the column entitled
Selected Columns.
d. Select OK. The changes are
implemented and the dialog box
closes.
Result/Comment
2-31

Section 2
Table 2.10
Procedure to Add/Delete Tab Pages in Data View
Task
Steps
Access the
Customize Data View
dialog box
1. Select Datalog or QC View from the

tool bar menu.
2. Select Setup and Customize Data
Customize Data View dialog box
opens.
3. To add or delete a tab page:
a. To remove a tab page from the
view:
1. Select the tab page name from
the pull-down menu at the Page
field.
2. Select the Del Page button and
the tab page is deleted from the
view.
3. Select OK. The changes are
implemented and the dialog
box closes.
b. To add a new tab page to the view:
1. Click on Add Page and an
entry entitled New Page is
added to the items listed in the
pull-down menu.
2. Name the new tab page and
add the column heading to the
selected columns.
3. Select OK. The changes are
implemented and the dialog
box closes.
Result/Comment

Moving Average View:
Tab view column heading (add/remove)
See Section 11: Quality Control, Subsection: Customize Moving Average View.
2-32
Section 2

Other Printed Report Options:
Graphs
Manual Differential Grids
Interpretive Report
Limits Report
2-33

Section 2

Table 2.11
To Customize the Printed Report Header
Tasks
Access the
Customize Printed
Report dialog box
Steps
Result/Comments
1. Select Setup and Customize

Printed Reports from the menu bar.
The Customize Printed Report
dialog box opens.
2. Select the Include Software

Version, Current Date/Time, and
Analyzer Name/Serial No.
checkbox.
3. Type in a four line Report Header or
any other information to appear in the
Report Header area.
4. Select OK the settings are
preserved and the dialog box closes.
2-34
Section 2

Table 2.12
Procedure to Auto Print Chartable Page Report
Task
Step
Accessing the
Customize Printed
Report dialog box
1. Select Customize Printed Report...

from Setup on the menu bar and the
Customize Printed Report dialog
box opens.
Selecting Auto Print

Options
1. Select one of the following options

from the Auto Print Chartable Page
Report:
None
All Specimens
Alerted Specimens only
2. Select one of the following buttons:
Click OK to accept the selections
and close the dialog box
Click Cancel to close the dialog
box without saving any of the
selections
Comment/Result
2-35

Section 2
Other Printed Report Options

Table 2.13
Procedure to Print Using Other Printed Report Options
Task
Step
Accessing the
Customize Printed
Report dialog box
1. Select Customize Printed Report...

from Setup on the menu bar and the
Customize Printed Report dialog
box opens.
Selecting Other
Printed Report
Options
2. Select one of the following options for

each of the items Graphs, Manual
Differential Grid, Interpretive Report,
and Limits Report from the Other
Printed Report Options:
None
All Specimens
Alerted Specimens Only
Saving and/or
Closing the
Selections
3. Select one of the following buttons:

Click OK to accept the selections
and close the dialog box
Click Cancel to close the dialog
box without saving any of the
selections
2-36
Comment/Result
Section 2
QCID Setup
Control Data for Commercial and Whole Blood
QC Limits:
Update Means and Limits
Standard Deviations
Retrieve from file
Westgard Rule Setup
See Section 11: Quality Control, Subsection: QCID File Setup.
Moving Average Acceptance Setup...

Moving Average Groups:
Lower and Upper Limits
Target Values
Action Limits
Number of Batches to display in view
See Section 11: Quality Control, Subsection: Moving Average Acceptance
Setup.
Administrative Setup
2-37

Section 2
Operators
Operators
The purpose of the security feature on the CELL-DYN Ruby is to allow laboratory
management to restrict write access to certain functions to specific laboratory
personnel, and to require the use of an operator ID where it is desired.
The following Operator access/permission levels are available in the software.
NOTE: Read access is to view only, and write access is to be able to make/save
changes, or perform functions.
Administrator read/write
Service read/write
Laboratory I customizable
Laboratory II customizable
Guest read only access
NOTE: Only Laboratory I and Laboratory II access/permissions may be changed.
The software can be configured to require password authorization and/or operator
sign-on for the following:
to change key configuration settings
to edit demographics
for calibration
These are the CELL-DYN Ruby software default Operator ID and associated
Access Levels:
Table 2.14
Operator ID and Access Levels
Operator ID
Access Level
Admin
Administrator
Guest
Guest
CSC
Service
FSE
Service
NOTE: CSC and FSE logins are for use only by Abbott personnel.
2-38
Section 2
An Administrator-level operator can perform the following functions:

Create new Operator accounts having any of the supported access levels,
except for Service level.
Remove Operator accounts, except for Guest, CSC, and FSE Operator IDs.
Require passwords (secure sign-on) for Operator accounts.
Select which functions may be assigned to the Laboratory I and
Laboratory II access levels.
Access a list of all Operator accounts and their Operator IDs (all those to
whom access has been granted).
Select a group of functions for which a second sign-on is required at the time
of performing the function.
An Administrator-level operator is able to set the following write access/
permissions with Operator accounts having the Laboratory I and
Laboratory II access level, as well as require a second sign-on in order to gain
access to the following:
Patient Sample Setup
Unit Sets Selection
Edit Specimens demographics (after data is acquired)
Bar Code Setup
Instrument ID Setup
LIS Setup
User Interface Preferences
Calibration
QC Setup/Deletion
Moving Average Setup
Diagnostics
2-39

Section 2
Operator Accounts
Table 2.15
Procedure to Add an Operator
Task
Step
Access the Operators

dialog box
1. Select Setup, Administrative Setup

and Operators... on the pull-down
menu. The Operators dialog box
opens.
2-40
Result/Comment
Section 2
Table 2.15
Procedure to Add an Operator (Continued)
Task
Add
Step
2. Click the Add button and the Add
Operator dialog box opens.
3. Enter the information in the fields:
Table 2.16
Add Operator Dialog Box
Operator ID
Limited to 6
alphanumeric
characters
Full name
Users name, 30
characters
maximum
Description
Optional, 50
characters
maximum
Secure sign
on
Select or deselect
to require operator
password
Password
15 character
maximum
Confirm
Password
Must be an exact
match
Access level
Select level to
determines
privileges
Save
4. Select the Create button and the

information is saved and the fields in
the dialog box are cleared for entry of
another Operator.
Exit
5. When all entries are completed,

select Close and the dialog box
closes.
Result/Comment
2-41

Section 2
Table 2.17
Procedure to Remove an Operator
Task
Step

dialog box

opens.
Remove
2. Highlight the operator ID to remove it

and click the Remove button. The
name is removed from the listing.
NOTE: Operator ID accounts for
Guest, FSE, and CSC cannot
be removed.
Exit
3. When all entries are completed,

select Close and the dialog box
closes.
2-42
Result/Comment
Section 2
Table 2.18
Procedure to Edit Operator Information
Task
Step

dialog box

opens.
Edit/View
2. Highlight the Operator ID and click

the Edit/View button and the View
Operator dialog box opens.
Result/Comment
2-43

Section 2
Table 2.18
Procedure to Edit Operator Information (Continued)
Task
Step
Result/Comment
3. Edit the following fields:

Table 2.19
Edit Operator Dialog Box
Full name
Users name, 30
characters
maximum
Description
Optional, 50
characters
maximum
Secure sign
on
Select or deselect
to require operator
password
Password
15 character
maximum
Confirm
Password
Must be an exact
match
Access level
Select level to
determines
privileges
4. Select the Modify button to save the

changes and the box closes.
5. Select Close to close the Operators
dialog box.
2-44
Section 2
Permission Access Rights for Laboratory I and II Levels

Laboratory management can utilize this feature to customize the access/
permissions for Laboratory I (e.g. general lab staff) and Laboratory II (e.g. lab
section managers).
2-45

Section 2
Table 2.20
Procedure for Editing Permission Access Rights for Laboratory Levels I and II
Task
Step
Access the
Operators dialog box

opens.
Edit permission
access rights
2. Click the Options button and the

Options dialog box opens.
2-46
Comment/Result
Section 2
Table 2.20
Procedure for Editing Permission Access Rights for Laboratory Levels I and II (Continued)
Task
Step
Comment/Result
3. Select the Laboratory I or

Laboratory II from the drop down
menu and access rights are
displayed.
4. Select the checkboxes as they apply
to your laboratorys setup.
Save
5. Select the Apply button to apply the

settings.
6. Select the OK button to close the
Options dialog box.
Exit
7. Select the Close button to close the

Operators dialog box.
2-47

Section 2
Second Sign On for All Access Levels

This customization can be set up to automatically display a message dialog box
prompting the Operator to re-enter their password when proceeding into the
following software functions:
Patient Sample Setup
Unit Sets Selection
Edit Specimens
Bar Code Setup
Instrument ID Setup
LIS Setup
Calibration
QC Setup / Deletion
Moving Average Setup
Diagnostics
Table 2.21
Procedure for Setting Up Second Sign Ons
Task
Step
Access the
Operators dialog box

opens.
2-48
Comment/Result
Section 2
Table 2.21
Procedure for Setting Up Second Sign Ons (Continued)
Task
Step
Open Second Sign

On dialog box.
2. Select the Options button and the

Options dialog box opens.
Setup second sign on
3. Select the Second Sign On tab and

the Second Sign On page opens.
4. Select or deselect the checkboxes as
they apply to your laboratorys set up.
Save
5. Select the Apply button to apply the

settings.
6. Select the OK button to close the
Options dialog box.
Exit
7. Select the Close button to close the

Operators dialog box.
Comment/Result
2-49

Section 2

QCID Daily Clean-up
Date Format
Set Date/Time and Time Zone
Figure 2.1
2-50
Section 2

The operator can use the mouse to point and roll over (for example: System
Messages, dialog box fields, and buttons) to display additional text descriptions
(tool tips) if available. Customization of this setting can be used to increase or
decrease the amount of time the tool tip will display.
Table 2.22
Changing the Tool Tip Display Time
Task
Changing the Tool
Tip Display Time
Step
Result/Comment
1. Using the mouse, click, hold, and

slide the bar to increase or decrease
the display time.
2. Select OK to save the setting.
QCID Daily Cleanup Time

The QCID Daily Cleanup time can be
set for the system to automatically
search for and delete aged QCID files.
See also Section 11: Quality Control,
Subsection: Program Operation,
QCID Files. To set the time for the
QCID Daily Cleanup to run, select the
time using the up and down arrows as
in the QCID Daily Cleanup area of the
User Interface Preferences dialog
box.
NOTE: While the QCID Daily
Cleanup is in process, the
Analyzer is not available to
run samples.
2-51

Section 2
Date/Time
To Set the Date, Time, and Zone
1. Select Setup, Administrative Setup, and User Interface Preferences...
from the menu bar. The User Interface Preferences... dialog box opens.
2. Select the alarm clock or Set Date/Time and the Date - Time Properties
dialog box opens.
2-52
Section 2
3. In the Date field, select the month using the pull-down menu, click on the day
in the calendar, and select the year.
4. In the Time field, select the current time by clicking on the clock or using the
up and down arrows, or typing in the correct time.
5. Select Time Zone tab and select the appropriate time zone.
6. The default for the daylight savings time (DST) feature is set as disabled.
To enable the DST feature, check Automatically adjust clock for daylight
savings changes box.
7. Click Apply and OK and the date and time are set.
8. Click OK and the User Interface Preferences dialog box closes.
Choosing a Delimiter
1. Select Setup, Administrative Setup, and User Interface Preferences...
from the menu bar. The User Interface Preferences... dialog box opens.
2. In the Date Format field of the dialog box, select one of the radio buttons.
3. In the Date Format field of the dialog box, select the type of delimiter [/]
or a dot from the drop down menu.
4. In the Time Format field of the dialog box, select one of the radio buttons.
5. Click OK and the User Interface Preferences dialog box closes and the new
formats are applied.
2-53

Section 2
Instrument ID Setup
The Instrument ID Setup contains the Analyzer serial number and makes it possible
to name the Analyzer. Naming the Analyzer is optional.
To complete the Instrument ID Setup:
1. Select Setup from the menu bar and Administrative Setup from the pulldown menu.
2. Select Instrument ID Setup... and the Instrument ID Setup dialog box

opens. The serial number, installed at the factory, is listed below the field for
the Analyzer name.
123456789
3. Fill in the Analyzer name.

4. Click OK and the Instrument ID Setup dialog box closes.
2-54
Section 2
5. Select Help and Instrument Information and the Instrument Information

dialog box opens and displays the Analyzer name.
2-55

Section 2
Bar Code Setup
Table 2.23
Procedure to Set Up Bar Code Including Symbology Setups
Tasks
Accessing the Bar
Code Setup dialog
box
2-56
Steps
Result/Comments

and Bar Code Setup... from the
menu bar. The Bar Code Setup
dialog box opens.
Section 2
Table 2.23
Procedure to Set Up Bar Code Including Symbology Setups (Continued)
Tasks
Steps
Activating the Check

Digit function
2. Select Include Check Digit for all

symbologies. The Set Analyzer
button is activated.
Updating Bar Code

Settings
3. Select Set Analyzer and the

message bar at the bottom of the
dialog box displays a message:
Barcode settings have been
updated.
4. Select the Close button and the Bar
Code Setup dialog box closes.
Result/Comments
2-57

Section 2
Orders Setup
Automatic Order Cleanup

The Automatic Order Cleanup can be set to automatically delete aged Pending
Orders in the Orders view. This can be set to delete approximately twelve (12) to
forty eight (48) hours after it was created and saved, or downloaded from the
Laboratory Information System (LIS). See also Section 5: Operating Instructions,
Subsection: Introduction to the Orders View.
2-58
Section 2
Table 2.24
Procedure to Change Automatic Order Cleanup
Task
Step
Comment/Result
1. Select Setup from the menu bar,

Administrative Setup from the pulldown menu, and Orders Setup....
The Orders Setup dialog box opens.
2. To change the default setting for
Automatic Order Cleanup, which is
48 hours, enter the new hours in the
field.
3. Select either OK to confirm the
changes or Cancel to keep Orders
Setup without any changes.
No Bar Code Setup

This option is not recommended. If you set up the System to identify pending
orders using rack and tube position matching, specimens run in the Closed Mode
without bar code labels must be carefully monitored to avoid specimen misidentification. See also Section 5: Operating Instructions, Subsection:
Introduction to the Orders View.
NOTE: This customization is only available when the Pending Orders log is
empty.
1. Select Setup, Administrative Setup and Orders Setup from the pulldown menu to open the Orders Setup dialog box.
2. Select the checkbox to use Rack and Tube matching or deselect the checkbox
to turn off Rack and Tube matching.
3. Select OK to save the setting.
2-59

Section 2
Table 2.25
Procedure to Change Use Rack and Tube Matching
Task
Step
Comment/Result

Administrative Setup from the pulldown menu, and Orders Setup....
The Orders Setup dialog box opens.
2. Select or deselect the Use Rack and
Tube Matching checkbox.
IMPORTANT: Selecting the checkbox
disables the use of the
bar code option.
changes or Cancel to keep Orders
Setup without any changes.
2-60
Section 2
LIS Setup
2-61

Section 2
The LIS Setup dialog box provides access to:

Enable LIS connection
Enable Auto-Transmission of specimen results and graphs for specimen
types: Patient and QC
Enable Manual Transmission of specimen results and graphs for specimen
types: Patient, QC, and Other Specimen Types
LIS Configuration Settings
LIS Tests
To enable the connection to a host computer, select the Enable LIS check box at
the top of the window. To disable the connection, uncheck the box.
Table 2.26
Setting Up Auto-Transmission and Manual Transmission
Task
Accessing the LIS
Setup dialog box
2-62
Step
Result/Comment

Administrative Setup from the pulldown menu, and LIS Setup... from
the extended menu.
OR
Select the F10LIS function key.
AND
The LIS Setup dialog box opens.
Section 2
Table 2.26
Setting Up Auto-Transmission and Manual Transmission (Continued)
Task
Auto Transmission
and Manual
Transmission tab
views
Step
Result/Comment
2. Make any changes.
3. Select Apply to apply the changes.
4. Select OK and dialog box and asking

whether to close.
5. Select Yes and the dialog boxes
close.
2-63

Section 2
LIS Configuration Tab View
Query All
The Query All function directs the CELL-DYN Ruby to periodically send a
message to the host computer requesting download of all outstanding orders. The
frequency of the Query All message can be configured from 1 to 120 minutes.
Selecting the Enable Query All checkbox in the LIS Configuration tab view
enables the function.
Host Query
The Host Query function allows the CELL-DYN Ruby to query the host computer
for order(s) for a specific Specimen ID. The function is enabled by selecting the
Enable Host Query checkbox in the LIS Configuration tab view. The period of
time (in seconds) that the analyzer will wait for a response from the host computer
can be specified in the Host Query Timeout field.
For more information on the use of the Host Query function, refer to Section 5:
Operating Instructions, Subsection: Specimen Analysis.
Strict Specimen ID Validation
The LIS Configuration tab view in the LIS Setup dialog box contains a checkbox
to enable/disable Strict Specimen ID Validation.
When Strict Specimen ID Validation is enabled (checked), only samples with a
valid Specimen ID will be transmitted to the host computer. If auto transmission of
results is enabled, samples without a valid specimen ID will be placed in the Not
Transmitted group. The Specimen ID must be edited before transmission of the
samples to the host computer will occur.
If Strict Specimen ID Validation is disabled (unchecked) and auto transmission is
enabled, all samples will be transmitted to the host computer.
2-64
Section 2
An invalid Specimen ID displays as Invalid_ID. For definition of requirements

for a valid Specimen ID, refer to Section 5: Operating Instructions, Subsection:
Specimen Analysis, Specimen ID Requirements.
If no entry is made in the Specimen ID field (blank), the Specimen ID will display
as No_ID and will not be transmitted to the host computer.
IMPORTANT: It is recommended that Strict Specimen ID Validation be enabled
when the host computer is a commercial LIS.
If you are not certain of the correct communication setup between the
CELL-DYN Ruby and the LIS, refer to the document CELL-DYN Ruby
Laboratory Information System Interface Specification, an orderable item listed in
Appendix A: Parts and Accessories, or consult your laboratorys computer staff.
For additional assistance, contact your Country Service and Support Center.
NOTE: Select 3-digit or 4-digit to display LIS results.
LIS Tests Tab View

The LIS Tests tab view provides access to tests used in troubleshooting the
CELL-DYN Ruby LIS connection.
QC Download ID File Setup

The QC Download ID File Setup information is used to enter Laboratory
Identification information for QC. This information is necessary for participants in
the CELL-DYN Interlaboratory QC Program. Laboratory Identification must be
entered before QC data can be transferred to the floppy disk. See Section 11:
Quality Control, Subsection: QC Download ID Setup.
2-65

Section 2
Flag Setting
This customization is used to enable ATYPDEP flagging sensitivity or disable the
ATYPDEP flag. See Section 3: Principles of Operation, Subsection: Data
Flagging.
Table 2.27
Flag Setting
Task
Steps
Accessing the Flag

Setting dialog box
Select Setup from the menu bar,

Administrative Setup from the pulldown menu, and Flag Setting... from
the extended menu.
The Flag Setting dialog box opens.
ATYPDEP
1. Turn on ATYPDEP flagging sensitivity

by selecting either Medium or High
radio button.
2. Turn off the ATYPDEP flagging by
selecting the Off radio button.
selections or Cancel to disregard the
changes.
2-66
Result/Comment
ATYPDEP:
O for Off
M for Medium
H for High
This setting is displayed and printed in
the demographics region on the Lab
Page view and is for lab use only.
Section 2
Logs Auto Backup Setup...

Logs Auto Backup Setup allows the user to set the time for an automatic daily
backup of the database.
Table 2.28
Logs Auto Backup Setup

Task
Steps
Result/Comment
Set up Time for Auto backup of

database
1. Select Setup from the menu

bar, Administrative Setup from
the pulldown menu, and Logs
Auto Backup Setup from the
extended menu. The Logs
Auto Backup Setup dialog box
opens.
System automatically backs up the

database daily at the set time. In
addition, the System automatically
backs up the database every hour
from the set time.
NOTE: The Default daily backup
time is midnight.
2. Set time for the daily backup of

the database.
NOTE: The CELL-DYN Ruby Software prevents exit from the application and
manual backup of system data during the time that automatic backup is in
process.
2-67

Section 2
Rule Setup...
Rule Setup is used to create rules and annotations for the Rules Based
Annotations feature. See Section 5: Operating Instructions, Subsection:
Advanced Data Management Rules Based Annotations.
2-68
Section 3 Principles of Operation
Section 3
Overview
The principles the CELL-DYN Ruby uses to measure, count and calculate the
hematological parameters are discussed in Sample Analysis Cycle Overview and
Introduction to Flow Cytometry within this section. Subsequent sections discuss
the measurement process for WBC, RBC, PLT, and HGB. The last subsection,
Operational Messages and Data Flagging, discusses the flags generated by the
instrument due to measured parameters outside predefined limits, sample
abnormality, interference in the measurement process, or detection of an abnormal
subpopulation. Quality Control methodology is discussed in Section 11: Quality
Control. Reticulocytes and Reticulocyte flagging are discussed in Section 12:
Reticulocyte Package.
The two independent measurement channels used in the CELL-DYN Ruby are:
The Optical channel for determining the WBC, NOC, and RBC/PLT data
The Hemoglobin channel for determining the HGB
During each instrument cycle, the sample is aspirated, diluted, and mixed before
each parameter is measured.
Sample Aspiration
There are two modes of sample aspiration on the CELL-DYN Ruby:
The Open Mode is used to aspirate the sample from a collection tube that has
been opened and is held under the open mode probe.
The Closed Mode is used to mix and then aspirate the blood directly from a
closed collection tube by piercing the tube stopper.
Refer to Section 4: Performance Characteristics and Specifications,
Subsection: Operational Specifications for Open and Closed mode aspiration
volumes.
Once the mode of aspiration is selected, the whole blood sample is aspirated to the
Shear Valve by vacuum/pressure action. An ultrasonic sensor, located upstream of
the Shear Valve, checks the integrity of the sample stream before it enters the Shear
Valve. An ultrasonic sensor and LED sensor, located downstream of the Shear
Valve, checks the sample stream to ensure the proper amount of sample has been
transferred through the Shear Valve.
3-1
Section 3
Overview
NOTES
3-2
Section 3
Sample Analysis Cycle Overview

NOTE: Sample and reagent volumes given in this section are stated as the
nominal values. Slight differences between instruments may cause these
volumes to vary. These differences are compensated for by factory-set
internal dilution factors.
Sample Aspiration
A sample is aspirated either in Open Mode or Closed Mode and transferred to the
Shear Valve.
Sample Segments
The Shear Valve rotates in order to separate three volumes of the aspirated sample.
The three volumes are:
20 L for the WBC dilution
1.67 L for the RBC/PLT dilution
12 L for the HGB dilution
RBC/PLT Analysis
1. The Diluent/Sheath Syringe dispenses 2.79 mL of diluent through the Shear
Valve where the 1.67 L RBC/PLT volume is transferred to the RBC Mixing
Chamber.
2. The segment and diluent are then routed to the RBC/PLT Mixing Chamber
where the dilution is mixed. The final dilution is 1:1675.
3. The Sample Transfer Pump transfers the RBC/PLT dilution from the RBC/
PLT Mixing Chamber to the Optical Flow Cell Sample Feed Nozzle.
4. Diluent/Sheath reagent, under constant pressure in the Sheath Reservoir, is
directed into the Optical Flow Cell.
5. Sequentially, the Sample Metering Syringe injects 24 L of the RBC/PLT
dilution into the flow cell at a pressure (and speed) lower than that of the
diluent/sheath reagent.
6. The higher speed of the sheath, which surrounds the RBC/PLT dilution, and
the special geometry of the flow cell combine to focus the RBC/PLT dilution
stream so that individual cells can be counted.
7. A laser beam is focused on the flow cell. As the sample stream intersects the
laser beam, the light scattered is measured at 0, 10, and 90 for red blood
cells, and at 0 and 10 for platelets.
3-3
Section 3
Hemoglobin Analysis
1. The Diluent/Sheath Syringe injects 1.7 mL of diluent through the Shear
Valve where the 12 L HGB volume is transferred to the HGB Flow Cell.
2. The HGB Lyse Syringe dispenses 0.9 mL of HGB Lyse into the line after the
diluent has transferred the HGB volume to the HGB Flow Cell. The entry
point for the HGB Lyse is between the Shear Valve and the HGB Flow Cell.
3. The segment, lyse, and diluent are routed to the HGB Flow Cell where the
dilution is mixed. The final dilution is 1:218.
4. A low-energy LED attached to the HGB Flow Cell measures the absorbance
of light at 555 nm. The absorbance is proportional to the HGB concentration
of the sample.
WBC Analysis
WBC are analyzed optically as follows:
1. The WBC Lyse Syringe dispenses 0.973 mL of WBC Lyse reagent through
the shear valve where the 20 L WBC volume is transferred to the WBC
Mixing Chamber/WOC Heater.
2. The segment and reagent are then routed to the WBC Mixing Chamber/WOC
Heater where the dilution is mixed. The final dilution is 1:50. The diluted
sample remains in the mixing chamber for 14 seconds for the lysing of the
red blood cells.
3. The Sample Transfer Pump transfers the WBC dilution from the WBC
Mixing Chamber/WOC Heater to the Optical Flow Cell Sample Feed Nozzle.
5. Sequentially, the Sample Metering Syringe injects 46.5 L of the WBC
dilution into the flow cell at a pressure (and speed) lower than that of the
diluent/sheath reagent.
6. The higher speed of the sheath, which surrounds the WBC dilution, and the
special geometry of the flow cell combine to focus the WBC dilution stream
so that individual cells can be counted.
laser beam, the light scattered by the cells is measured at four different
detectors located in the forward (0 and 10) and side (90 and 90D) angles.
3-4
Section 3
Fragile WBC and Resistant RBC

When running patient samples in the CBC test selection, the operator may suspect
the presence of fragile WBC when the FWBC flag is displayed or may suspect the
presence of resistant RBC when the RRBC and NRBC flags are displayed.
In the case of samples containing fragile WBC or resistant RBC, alternate test
selections are used to measure white blood cells. The results of these test selections
are referred to as the Nuclear Optical Count (NOC). The NOC measurement is
derived from the HGB dilution as described below. Refer to Subsection: Nuclear
Optical Count (NOC) and Resistant RBC later in this section for additional
information.
The CBC+NOC test selection is available for fragile WBC and the CBC+RRBC
test selection is available for resistant RBC. Refer to Section 5: Operating
Instructions, Subsection: General Concepts for Reorder Entries from the
Datalog and Group Views.
When the CBC+NOC test is selected, both NOC and WOC are reported in the
Datalog. The NOC value is reported as WBC in the Datalog and on the Run View.
When the CBC+RRBC test is selected, both NOC and WOC are reported in the
Datalog. Either NOC or WOC is reported as WBC (based on algorithmic decisionmaking) in the Datalog and on the Run View.
NOTE: When a Quality Control ID (QCID) is run using the CBC+NOC test
section both NOC and WOC are reported in the Datalog. Either NOC or
WOC is reported as WBC (based on algorithmic decision-making) on the
Run View.
The analysis for CBC+NOC and CBC+RRBC is performed as follows:
1. After the HGB sample is measured (refer to Subsection: Hemoglobin
Analysis earlier in this section), the Sample Transfer Pump transfers the
diluted solution from the HGB Flow Cell to the Optical Flow Cell Sample
Feed Nozzle.
3. Sequentially, the Sample Metering Syringe injects 140 L of the HGB
dilution into the flow cell.
4. The higher speed of the sheath which surrounds the HGB dilution, and the
special geometry of the flow cell, focus the HGB dilution stream so that
individual cells can be counted.
laser beam, the light scattered by the cells is measured by the 0 degree
detector. The nuclei of the lysed cells are counted as the NOC result.
6. The WBC Analysis in the CBC+NOC test selection occurs as described in
Subsection: WBC Analysis earlier in this section.
7. The WBC Analysis in the CBC+RRBC test selection occurs as described in
WBC Analysis above except that the diluted WBC segment is lysed in the
WBC Mixing Chamber/WOC Heater for an additional 15 seconds.
3-5
Section 3
Results Displayed
All data is transmitted to the Data Module Computer for analysis. Results are
computed for all parameters and are displayed on the Run View. Results are also
stored in a log format called the Datalog.
Instrument Flushed
1. The remaining sample segment from the aspiration process is flushed to
Waste Chamber #2.
2. The remaining segments in the WBC and RBC/PLT Mixing Chambers are
flushed to Waste Chamber #3.
3. The segments sent to the Optical Flow Cell are flushed to Waste Chamber #1.
Instrument Rinsed
1. The Open Mode Probe is rinsed internally and externally with Diluent/
Sheath.
2. The Closed Mode needle is rinsed internally and externally with Diluent/
Sheath.
3. The WBC Mixing Chamber/WOC Heater is rinsed with WBC Lyse.
4. The RBC/PLT Mixing Chamber is rinsed with Diluent/Sheath.
5. The Optical Flow Cell and Sample Line tubing are rinsed with Diluent/
Sheath.
6. The HGB Flow Cell is rinsed with Diluent/Sheath.
3-6
Section 3
Flow Cytometry
Introduction to Flow Cytometry
The CELL-DYN Ruby uses flow cytometric techniques to analyze the RBC/PLT,
WBC, and NOC populations. This section gives a brief introduction to the
principles of flow cytometry.1
Flow cytometry is a process in which individual cells or other biological particles
in a single file produced by a fluid stream are passed through a beam of light. A
sensor or sensors measure, by the loss or scattering of light, the physical or
chemical characteristics of the cells or particles.2
Flow cytometry enables the rapid screening of large numbers of cells and provides
quantitative cell analysis at the single-cell level. The basic components of a flow
cytometer include:
A sample collector and transporter
A flow system to focus the sample flow stream
A light source and focusing optics
Light collectors, signal detectors, and polarizers
Data collection and storage
Data display and analysis
1 Orthogonal (90 and
90D) Scatter Light
Detectors
2 Laser Tube
3 Forward Angle (0 and
10) Light Detectors
4 Optical Flow Cell
5 Laser Cover
3
5
Figure 3.1
Optical Bench
3-7
Section 3
Flow Cytometry
Detection with the Optical Bench

The optical bench assembly contains the components that make up the flow
cytometer. It is depicted in the previous figure. The main purpose of the optical
bench is to detect the light scattered by the cells as they pass through the flow cell.
The detection process is discussed in this section.
The light source is a vertically polarized 10 mW helium-neon laser with a
wavelength of 632.8 nm. The laser beam passes through a cylindrical lens which
changes the shape from a circle to an ellipse. The beam is then directed through a
125 m slit which blocks the weaker outer edges. This process yields a uniformly
intense beam approximately 80 m wide that allows the cell stream to wander
slightly in the flow cell and still be exposed to the same light intensity. An imaging
lens centers the focused laser beam onto the quartz flow cell.
The Sample Transfer Syringe injects different sample dilutions into the sheath
stream in the Optical Flow Cell. The sample is hydrodynamically focused into a
small stream approximately 30 m in diameter. This focused stream aligns the
diluted cells in single file as they pass through the light beam, which allows them
to be detected one at a time in the sensing region of the detectors.
Since the average diameter of the cells are smaller than the focused laser beam, the
cells do not scatter much laser light. If the remaining unscattered light were
allowed to reach the 0 and 10 (forward) detectors, it would saturate the
electronics. Therefore, an obscuration bar blocks 0 1 of the forward unscattered
light beam. The forward angles of scatter are directed to a perforated mirror. The
0 (1 3) light scatter passes through the mirror to the 0 silicon photodiode
detector. The 10 (7 10 or narrow angle) light scatter is deflected off the mirror
to the 10 silicon photodiode detector.
The orthogonal scatter is directed through a 700 m slit which blocks the scatter
from the walls of the flow cell. A beam splitter then separates the orthogonal light
scatter into two portions. One portion of the light is directed to the 90 Photo
Multiplier Tube (PMT). The remaining light is directed through a horizontal
polarizer. Only light that has changed polarization (depolarized) can pass through
the polarizer to the 90D PMT. (PMTs are used because relatively little light is
scattered at this angle.)
The light signals collected by each detector are converted into electrical signals or
pulses. The pulses are digitized based on intensity and sorted into 256 channels for
each angle of light measured.
If a pulse falls above the hardware threshold in the 0 and 10 detectors, the cell
counter counts the pulse and stores it for further evaluation. Pulses that fall below
this threshold are not included in the count.
The information from each detector is collected in list mode. This format stores the
channel information from each of the four dimensions. The data is then used to
determine the WOC differential and RBC, PLT, and NOC counts.
3-8
Section 3
1
2
3
4
5
Sample Feed Nozzle

Sheath Stream
Sample Stream
Focused Laser Beam
Various Angles of
Scattered Light
4
3
2
1
Figure 3.2
Optical Flow Cell
Optical Flow Cell

In a flow cytometer, the cell suspension is transferred from the mixing chamber
through a sample tube into a special flow chamber with a small opening at the tip. The
suspension is then injected into a stream of fast-moving, cell-free liquid (sheath
fluid). Since the two liquids travel at different rates of speed, they do not
intermingle. The special geometry of the flow cell and the flow rate of the sheath
fluid forces the cells into single file. This process is known as hydrodynamic
focusing. (Refer to Figure 3.2 for a drawing of the Optical Flow Cell.)
As the cells enter the view volume (specific viewing area), they intersect with the
laser beam. The different types of cells scatter the laser light at different angles,
yielding information about cell size, internal structure, granularity and surface
morphology. The optical signals the cells generate are detected and converted to
electrical impulses which are then stored and analyzed by the computer.
Flow cytometers generally measure two angles of scatter. Forward angle light
scatter is a measure of cell size. Side angle (orthogonal) light scatter is a measure
of cell surface and internal structure but is primarily a measurement of internal
granularity. Combining the information from the two scatter measurements
provides more accurate discrimination between cell populations than either single
measurement. (See Figure 3.3 for an example of the light scatter measured by the
CELL-DYN Ruby.)
3-9
Section 3
Flow Cytometry
WBC Measurement
Overview
The Optical Channel is used for the determination of WBC data. During sample
aspiration, 20 L of sample is segmented in the Shear Valve for WBC
measurement. The WBC Syringe dispenses 0.973 mL of WBC lyse to the Shear
Valve. The sample and lyse are then transferred to the WBC Mixing Chamber/
WOC Heater where the dilution is mixed, resulting in a 1:50 dilution ratio.
The Sample Transfer Pump transfers the WBC dilution from the mixing chamber
to the sample feed nozzle in the Optical Flow Cell. At the same time, sheath
reagent, under constant pressure in the Sheath Reservoir, is transferred to the sheath
feed nozzle in the Optical Flow Cell and injected into the cell. At the same time,
the Sample Metering Syringe injects 46.5 L of the WBC dilution into a sheath
stream. The sample stream is then hydrodynamically focused to align the cells in
single file as they pass through the Optical Flow Cell, which is an optically clear
quartz chamber. A vertically polarized Helium Neon Laser is the light source.
The instrument measures:
Both types of forward angle light scatter (1 to 3, referred to as 0, and 7 to
11, referred to as 10 or narrow angle)
Both types of orthogonal (side) light scatter (70 to 110, referred to as 90,
and 70 to 110 depolarized, referred to as 90D).
This is referred to as MAPSS (for Multi-Angle Polarized Scatter Separation)
technology. Various combinations of these four measurements are used to classify
the WBC subpopulations and provide morphological flagging.
1
2
3
4
5
Focused Laser Beam

0 Scatter
10 Scatter
90 Scatter
90D Scatter
Figure 3.3
3-10
1
2
WBC Light Scatter
Section 3
The previous figure illustrates the measurement of light scattered during the WBC
optical measurement process.
The WBC count is determined by enumerating the number of occurrences above a
hardware threshold in the 0 channel. The information from all four measurements
is used to differentiate the WBC into five subpopulations:
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils
The WBC data is presented graphically as scatterplots or histograms.
WBC Reagent
The WBC reagent used with the CELL-DYN Ruby instrument is the CELL-DYN
WBC Lyse. It is an integral part of the WBC analysis. White blood cells diluted in
the reagent maintain cellular integrity close to their native state. The structure of
the basophils changes slightly due to the hygroscopic nature of the basophilic
granules.
The RBC are also altered by the reagent. The osmotic pressure of the RBC is higher
than that of the reagent. Therefore, the hemoglobin in the RBC diffuses out of the
cell and water from the reagent diffuses into the cell. The cell membrane remains
intact but the RBC now has the same refractive index as the sheath, thereby
rendering it invisible to the laser.
WBC Differential
The light scatter information is graphically presented in the form of scatterplots.
(The data can also be presented in histograms.) Each cell analyzed is represented
by a dot on the scatterplot. The dots are plotted at a point determined by the
intersection of the channel information designated on the X and Y axes. For
example, if a cell falls in channel 50 on the X axis and channel 50 on the Y axis, it
is plotted at the intersecting point of the two channels.
The scatter information may be plotted in various combinations to yield different
information. The CELL-DYN Ruby uses the scatterplots to differentiate the WBC
into five subpopulations:
Neutrophils
Eosinophils
Lymphocytes
Basophils
Monocytes
3-11
Section 3
Flow Cytometry
Mononuclear Polymorphonuclear
Identification
90 Lobularity
90 Lobularity
Mononuclear Polymorphonuclear
Separation
10 Complexity
Figure 3.4
10 Complexity
Mononuclear-Polymorphonuclear Scatter
Mononuclear-Polymorphonuclear Separation
The scatter information is plotted with the 90 scatter on the Y axis and the 10
scatter on the X axis. (The 90/10 scatterplot is shown in the previous figure.) Two
populations of cells are clearly seen on the display. The mononuclear cells fall in
the cluster in the lower left corner of the scatterplot and the polymorphonuclear
cells fall in the cluster above and to the right of them.
The instrument uses a dynamic threshold to determine the best separation between
the two populations. Each cell is then identified as a MONO or a POLY. Once each
cell is identified, it retains this classification no matter where it appears on other
scatterplots.
3-12
Section 3
90 Lobularity
Figure 3.5
Neutrophil Eosinophil
Identification
90 Depolarized Granularity
90 Depolarized Granularity
Neutrophil Eosinophil
Separation
90 Lobularity
Neutrophil-Eosinophil Scatter
Neutrophil-Eosinophil Separation
The scatter information is plotted with the 90D scatter on the Y axis and the 90
scatter on the X axis. (The 90D/90 scatterplot is shown in the previous figure.)
Only the polymorphonuclear cells are plotted on this scatterplot. The mononuclear
cells have been identified and therefore do not interfere in the further classification
of the polymorphonuclear cells.
Two populations of polymorphonuclear cells are clearly seen on the display. The
neutrophils fall in the lower of the two clusters. The eosinophils fall in the upper
cluster. The instrument uses a dynamic threshold to determine the best separation
between the two populations. Each cell is then classified as a NEUT or an EOS.
All cells scatter a certain amount of 90D light. The eosinophils scatter more 90D
light than any of the other cells because of the unique nature of granules they
contain. This property of the eosinophils is used to positively identify them and
thus clearly differentiate them from the neutrophil population.
3-13
Section 3
Flow Cytometry
10 Complexity
Figure 3.6
Mononuclear
Identification
0 Size
0 Size
Mononuclear
Separation
10 Complexity
Mononuclear Scatter
Mononuclear Separation
scatter on the X axis. (The 0/10 scatterplot is shown in the previous figure.) The
mononuclear cells are plotted on this scatterplot. The algorithm also uses the
orientation of the neutrophil cluster to aid in classifying the mononuclears. Three
populations of mononuclear cells are clearly seen on the display.
There are three populations of mononuclears because basophils are included in the
mononuclear cluster. Typically, basophils are granulated cells and therefore more
complex than the mononuclear cells. However, the basophilic granules are water
soluble and dissolve in the WBC Lyse reagent. Consequently, the degranulated
basophils becomes a less complex cell that falls into the mononuclear cluster.
The lymphocytes fall in the lowest large cluster. (The small population of cells
below the lymphocytes contains particles that are unlikely to be WBC.) The
basophils fall in the cluster above and slightly to the right of the lymphocytes. The
monocytes fall in the cluster above the lymphocytes and basophils. The instrument
uses dynamic thresholds to determine the best separation between the three main
populations. Each cell is then classified as a LYMPH, a MONO or a BASO.
3-14
Section 3
Finally, the instrument evaluates the area below the lymphocyte cluster but above
the hardware threshold (channel 23). Any particles that fall in this area are
separated from the lymphocytes by a dynamic threshold. The following cell types
may be present in this region:
NRBC
Unlysed RBC
Giant PLT
PLT clumps
All particles in this region are excluded from the WBC count and the Differential.
Other Scatterplots
90/0
scatter on the X axis.
90D/0
90D/10
All scatterplots may be displayed and printed at operator request.
Nuclear Optical Count (NOC)

Samples containing fragile WBC are difficult to measure accurately because of the
rapid breakdown of cells during the measurement process. To obtain an accurate
WBC count, an alternate method using the HGB segment (instead of the WBC
segment) is used to measure samples containing fragile WBC.
The HGB sample segment, after being measured in the HGB Flow Cell, is
transferred to the Optical Flow Cell instead of being sent to a waste chamber as in
the CBC test selection. While in the HGB Flow Cell, the HGB reagent lyses the
cytoplasmic membrane of the white blood cells but allows the nuclear membrane
to remain intact. This results in a greater stability of the white cells in the sample.
The HGB segment is lysed for approximately 15 seconds before it is sent to the
Optical Flow Cell.
As the HGB segment passes through the Optical Flow Cell, the nuclei of the cells
are counted. The results of this measurement are stored in the Datalog as NOC.
3-15
Flow Cytometry
Section 3
Resistant RBC
When a specimen containing resistant RBC is run in the CBC test selection, the
lytic agent in the WBC lyse reagent may be insufficient to lyse the resistant cells
in the time allotted for the WBC count. Consequently, unlysed RBC can be
erroneously included in the WBC count resulting in a falsely elevated value. When
this occurs, a significant amount of cellular debris will be present in the region
below the WBC dynamic threshold on the 0/10 scatterplot.
When these types of specimens are rerun in the CBC+RRBC test selection, the
diluted WBC sample is held in the mixing chamber 15 seconds longer than in the
routine patient mode. This additional lysing time is used to break down (lyse) the
resistant RBC cells and prevent them from interfering with the WBC count and
differential.
NOTE: A higher incidence of false positive band flags may be evident on
specimens run under the Resistant RBC test selection.
3-16
Section 3
WBC Histograms
Figure 3.7
WBC Histograms
The CELL-DYN Ruby can present the WBC scatter information as two
histograms: NWBC-LYM-MONO (N-L-M) and Mono-Poly (M-P). The NOC
(Nuclear Optical Count) data can also be presented as a histogram. (Refer to the
previous figure.) These histograms may be displayed and printed at the operators
request.
NWBC-LYM-MONO Histogram
The scatter information is plotted in a histogram format with the relative number
of cells on the Y axis and the NWBC, Lymphocyte and Monocyte size distribution
data on the X axis.
MONO-POLY Histogram
The scatter information is plotted in a histogram format with the relative number
of cells on the Y axis and the mononuclear and polymorphonuclear size
distribution data on the X axis.
NOC Histogram
The NOC data is plotted in a histogram format with the relative number of nuclei
on the Y axis and the size distribution data on the X axis.
3-17
Section 3
Flow Cytometry
WBC Parameters
Figure 3.8
WBC Data and Scatterplots
The WBC data is generally displayed as depicted in Figure 3.8. All numeric and
graphic data are automatically displayed in the Run View Chartable, Lab, and
Graphics tabs in the format selected in Customizing Run View. See
Subsection: Customize Run View. After the WBC scatter information has been
plotted and the cells have been classified into the five subpopulations, the
algorithms then determine the WBC and the percent of cells in each subpopulation.
Once the WBC count is determined, the absolute number of cells in each
subpopulation is calculated by multiplying that WBC count by the percentage. The
results are expressed as follows:
WBC
NEU
LYM
MONO
EOS
BASO
# x 10e3/L
# x 10e3/L and %
# x 10e3/L and %
# x 10e3/L and %
# x 10e3/L and %
# x 10e3/L and %
The decimal point moves to display up to three decimal places for the absolute
number and percent.
3-18
Section 3
The WBC subpopulations are further identified by the following colors:

Neutrophils yellow
Lymphocytes blue
Monocytes
purple
Eosinophils green
Basophils
white
NOTE: The basophils are displayed as white dots but appear as black dots on
color printouts.
The WBC scatter information is usually displayed in two scatterplots as shown in
the previous figure.
SIZE/COMPLEXITY
The size (0 scatter) information is plotted on the

Y axis and the complexity (10 scatter) information
is plotted on the X axis.
GRANLRTY/LOBULARITY The granularity (90D scatter) information is plotted

on the Y axis and the lobularity (90 scatter)
information is plotted on the X axis.
WBC Flagging
Refer to the Operational Messages and Data Flagging subsection of this section
for WBC flagging information.
RBC/PLT Measurement
Overview
The Optical Channel is used for the determination of RBC and PLT data. During
sample aspiration, 1.67 L of sample is segmented in the Shear Valve for RBC/PLT
measurement.
The Diluent/Sheath Syringe dispenses 2.79 mL of diluent to the Shear Valve. The
sample and diluent are then transferred to the RBC/PLT Mixing Chamber where
the dilution is mixed, resulting in a 1:1675 dilution ratio.
The Sample Transfer Pump transfers the RBC/PLT dilution from the mixing
chamber to the sheath feed nozzle in the Optical Flow Cell. The Sample Metering
Syringe injects 24 L of RBC/PLT dilution into the sheath stream. The sample
stream is then hydrodynamically focused to align the cells in single file as they pass
through the Optical Flow Cell, which is an optically clear quartz chamber. A
vertically polarized Helium Neon Laser is the light source.
There are 256 size channels for each of the parameters, each RBC size channel
being equivalent to 1 fL and each PLT size channel being equivalent to 0.137 fL.
The RBC parameters are calculated using 0, 10, and 90 sensor data, while the
PLT parameters are calculated using 0 and 10 sensor data.
3-19
Section 3
Flow Cytometry
RBC Parameters
Figure 3.9
RBC Data and Histogram
All numeric and frequency size distribution data are automatically displayed on the
Run View in the format selected. The size distribution data for the red cells is
displayed graphically as a histogram using 0 data. The size distribution data is
plotted on the X axis. The relative number of cells is normalized and plotted on the
Y axis. The RBC data are shown in the previous figure.
RBC Count
The Red Blood Cell Count is directly measured, and is expressed as follows:
RBC = # x 10e6/L
Counts below 1.0 x 10e6/L are displayed to three decimal places. The RBC count
is corrected for coincidence and WBC interference.
MCV
The Mean Cell Volume is the average volume of the individual red blood cells.
The MCV is derived from the RBC size distribution data on the 0, 10, and 90
histograms, and is expressed in femtoliters.
3-20
Section 3
HCT
The Hematocrit is the ratio of red blood cells to plasma and is expressed as a
percentage of the whole blood volume. The HCT is calculated from the red blood
cell count and the mean cell volume as follows:
HCT = (RBC x MCV)/10
MCH
The Mean Corpuscular Hemoglobin is the average amount of hemoglobin
contained in the red blood cell expressed in picograms. The MCH is calculated
from the RBC and the HGB as follows:
MCH = (HGB/RBC) x 10
MCHC
The Mean Corpuscular Hemoglobin Concentration is the ratio of the weight of
hemoglobin to the volume of the average red blood cell expressed in grams per
deciliter. MCHC is calculated from the HGB and the HCT as follows:
MCHC = (HGB/HCT) x 100
RDW
Red Cell Distribution Width is a measure of the heterogeneity of the RBC
population. The CELL-DYN Ruby reports a relative RDW equivalent to a CV in
grams per deciliter. The RDW is derived from the RBC histogram using the 20th
and 80th percentiles.
RBC Flagging
Refer to Subsection: Operational Messages and Data Flagging for RBC Flagging
information.
Platelet Parameters
Events counted in the RBC/PLT dilution between floating thresholds are included
in the platelet (PLT) data, which is collected using the 0 and 10 sensors. The
lower threshold floats between 1 and 3 fL and the upper threshold floats between
15 and 35 fL. If there are not enough data to determine the PLT count, the lower
and upper thresholds are set at 2 and 35 fL respectively. Once the thresholds have
been determined, the PLT count is derived from the 10 data.
Data can be displayed in two formats. Data can be displayed as a scatterplot (0/
10) including the RBC. Data can also be displayed as one of the following three
histograms:
PLT only using 10 data
PLT and RBC using 0 data
PLT and RBC using 10 data
PLT data are shown as a histogram of the 10 data in the following figure.
3-21
Section 3
Flow Cytometry
Events counted in the region below the lower threshold are usually either optical
noise or small particulate matter. Events counted in the region above the upper
threshold are counted as RBC. If interference with either threshold region exceeds
a predetermined limit, the PLT parameters are flagged accordingly. The flags are
discussed in the last section of this section.
PLT Count
The PLT count is expressed as thousands per microliter (10e3/L).
Figure 3.10 PLT Data and Histogram
MPV
The Mean Platelet Volume is derived from the PLT histogram after the PLT count
has been determined. The MPV is expressed in femtoliters.
PCT
The Plateletcrit is the product of PLT and MPV and is analogous to the hematocrit.
It is expressed in percent and is calculated as follows:
PCT = (PLT x MPV)/10
PDW
Platelet Distribution Width is a measure of the heterogeneity of the PLT
population. It is expressed as the geometric standard deviation.
NOTE: Clinical significance has not been established for PCT and PDW.
Therefore, they are not reportable in the US.
3-22
Section 3
Platelet Flagging
Refer to Subsection: Operational Messages and Data Flagging for PLT flagging
information.
Hemoglobin Measurement
Overview
The HGB channel is used for the colorimetric determination of hemoglobin.
During sample aspiration, 12 L of sample is segmented in the Shear Valve for
HGB measurement.
The Diluent/Sheath Syringe dispenses 1.7 mL of Diluent/Sheath to the Shear
Valve, transferring the HGB segment to the HGB Mixing Chamber. The HGB Lyse
Syringe then dispenses 0.9 mL of HGB Lyse into the mixing chamber. The mixture
is mixed, resulting in a 1:218 dilution ratio. The HGB lyse reagent lyses the red
blood cells, converting the hemoglobin that is released by a cyanide-free chemical
process. When the lysing action is completed, a low-energy LED in the HGB Flow
Cell, attached to the mixing chamber, measures the amount of absorbance which is
proportional to the HGB concentration. Five separate HGB readings are made on
the sample. The lowest and highest are eliminated and the remaining three are
averaged to give the final HGB sample reading. After the hemoglobin readings
have been made, the HGB Flow Cell is rinsed with diluent/sheath.
A reference value is then obtained using the diluent/sheath in the HGB Flow Cell.
A zero or blank reading is obtained on the diluent to provide a reference to which
the sample signal is compared. Five separate blank readings are made on the
diluent. The lowest and highest are eliminated and the remaining three are
averaged to give the final HGB reference reading.
A LED with a wavelength of 555 nm is the light source. A photodetector measures
the light that is transmitted.
The sample and reference readings are compared to determine the HGB
concentration of the sample. The HGB result is expressed in grams of hemoglobin
per deciliter of whole blood. Up to two decimal places may be displayed for
hemoglobin results less than 10.0 g/dL.
HGB Parameters
The Hemoglobin is directly measured and is expressed in grams of hemoglobin per
deciliter of whole blood.
HGB Flagging
Refer to Subsection: Operational Messages and Data Flagging for HGB flagging
information.
3-23
Section 3
Flow Cytometry
Lab Page
The Run View Lab Page is provided to assist the laboratory staff in data review and
validation (refer to the following figure). This screen is for laboratory use only. The
lab page displays the 5-Part Differential plus additional parameters. The Run View
Chartable Page displays only the 5-Part Differential (refer to the figure in the WBC
Scatterplots subsection). The difference between the two formats is shown in the
following tables.
NOTE: The parameters MON and LYM have an e after the label, indicating that
the values are estimated. MONe represents monos minus blasts. LYMe
represents reported lymphs minus variant lymphs.
Figure 3.11 Lab Page
All numeric and graphic data are automatically displayed in the Run View Lab tab
in the format selection in Customize Run View. See Section 2: Installation
Procedures and Special Requirements, Subsection: Customize Run View.
The 5-Part Differential separates WBC into 5 components: Neutrophils,
Lymphocytes, Monocytes, Eosinophils, and Basophils. The additional parameters
further separate the Neutrophils, Lymphocytes, and Monocytes into their
constituent components. Eosinophils and Basophils are the same in both tables.
3-24
Section 3
Table 3.1
5-Part Differential
Parameter
Results (10e3/L)
WBC
7.23
NEU
4.65
LYM
1.67
MONO
.639
EOS
.228
BASO
.045
Table 3.2
5-Part Differential Plus Additional

Parameters
Parameter
Results (10e3/L)
WBC
7.23
NEU
1a
SEG
4.40
1b
BAND
.208
1c
IG
.038
MONO
3a
BLST
.001
3b
MONe
.638
EOS
.228
BASO
.045
LYM
2a
LYMe
1.64
2b
VARL
.030
3-25
Section 3
Flow Cytometry
NOTES
3-26
Section 3
Operational Messages and Data Flagging

Introduction
Operational messages and data flags appear on the Run View, screen, on printed
reports and can be transmitted to a laboratory computer system. The
CELL-DYN Ruby monitors instrument conditions and data criteria that may affect
the displayed results and these messages and flags are used to alert the operator.
Instructions for interpreting all flags, and numeric, scatter and histogram data
should be incorporated into the laboratorys procedure and used to determine the
need for further action and/or review of results. Messages are divided into the
following categories:
System Messages:
Fault Conditions
Status Conditions
Parameter Flagging Messages:
Suspect Parameter Flags
Suspect Population Flags
Interpretive Messages
Detailed descriptions of the messages in each of the categories are given in this
section.
Instrument Fault and Status Conditions

The Instrument Fault and Status conditions are discussed in Section 10:
Troubleshooting and Diagnostics, Subsection: System Messages. These
messages are displayed when the instrument detects an inappropriate condition
during specimen processing. When necessary, data is suppressed. When any of
these messages are displayed, refer to the System Messages for assistance. Follow
the instructions given and take the appropriate corrective action. When the problem
is corrected, repeat the specimen.
3-27
Section 3
Cell Populations and Flagging

Fragile WBC
Typically, fragile WBC are abnormal lymphocytes that are present in chronic
lymphocytic leukemia (CLL) and are the smudge cells that appear when the
blood smear is made.
When processing samples in the CBC test selection, if fragile WBC are present the
WBC (WOC) count may be abnormally low due to the gradual destruction of the
cytoplasmic membrane of these fragile cells by the lysing agents during the run
cycle.
When the FWBC flag displays, repeat the specimen using the CBC+NOC test
selection. This selection uses the HGB sample dilution containing intact WBC
nuclei. This Nuclear Optical Count (NOC) provides a more accurate WBC count
when fragile WBC are present.
Lyse-Resistant RBC
Lyse-resistant RBC are red blood cells which contain abnormalities or whose
membranes have been altered, making them more resistant to the lysing process.
When running samples in the CBC test selection, the hypo-osmotic lysing ability
of the WBC Lyse reagent is usually insufficient to lyse any lyse-resistant RBC, if
present, in the time allotted for the WBC count. Consequently, the unlysed RBC
may be erroneously included in the WBC count, resulting in a falsely elevated
count.
In normal patient samples, lyse-resistant RBC are either absent or their number is
negligible. In patient samples with a significant number of lyse-resistant RBC,
usually there is also a significant amount of cellular debris interference present in
the region below the dynamic WOC threshold on the 0 / 10 scatterplot.
When cellular debris interference is suspected and other conditions are met, the
RRBC/NRBC (Resistant RBC/Nucleated RBC) flag is displayed, alerting the user
to run the specimen in the CBC+RRBC test selection. The WBC lyse time is
extended, allowing for a complete lysing of the lyse-resistant RBC to obtain an
accurate WBC count.
For samples suspected of containing NRBC or resistant RBC, or those whose
smear review indicates the presence of NRBC (e.g., sickle cells or target cells may
indicate that NRBC are also present), run the sample(s) in the CBC+RRBC test
selection to verify the WBC count.
3-28
Section 3
Parameter Flagging Messages

Table 3.3 summarizes all of the parameter flagging messages by parameter and
category.
Table 3.3
Parameter Flagging Messages
Parameter

Result displays in yellow if
below lower limit
Suspect
Parameter Flags
Interpretive
Messages
WBC
NWBC
FWBC
NRBC
RRBC
Leukopenia
Leukocytosis
DFLT (NLMEB)
DFLT (NE)
DFLT (LM)
DFLT (B)
DFLT (LB)
BAND
IG
BLAST
VAR LYM
Neutropenia
Neutrophilia
Lymphopenia
Lymphocytosis
Monocytosis
Eosinophilia
Basophilia
RBC MORPH
Anemia
Polycythemia
Microcytic RBC
Macrocytic RBC
Hypochromic
Hyperchromic
Anisocytosis
Result displays in purple if

above upper limit
WBC
Suspect
Population Flags
Result underlined on graphics

printout when limits exceeded
Result marked with asterisk (*)
if further result validation is
required. (See Table 3.4)
Differential
NEU
LYM
MONO
EOS
BASO
RBC
HGB
MCV
RDW
PLT
MPV
Same as WBC
Same as WBC
Same as WBC
LRI
URI
LURI
Thrombocytopenia
The MPV value
may be suppressed Thrombocytosis
(not displayed
Microcytic PLT
or printed).
Macrocytic PLT
3-29
Section 3
The following summarizes all of the parameters marked with an asterisk (*)
requiring further result validation.
NOTE: This applies to Patient, Quality Control ID (QCID) whole blood, and
Calibrator whole blood Specimen Types.
Table 3.4
Parameters Marked With an Asterisk (*)
Suspect
Parameter Flag
Parameters marked with an asterisk (*)

on Chartable Page
Parameters marked with an

asterisk (*) on Lab Page
WBC
WBC, NEU, MONO, EOS, BASO, LYM
WBC, SEG, BAND, IG, BLST, MONe,

EOS, BASO, LYMe, VARL
DFLT (NLMEB)
NEU, MONO, EOS, BASO, LYM, %N,

%M, %E,%B, %L
SEG, BAND, IG, BLST, MONe, EOS,

BASO, LYMe, VARL, %S, %BD, %IG,
%BLST, %Me, %E, %B, %Le, %VL
DFLT (NE)
NEU, EOS, %N, %E
SEG, BAND, IG, EOS, %S, %BD, %IG,

%E
DFLT (LM)
MONO, LYM, %M, %L
BLST, MONe, LYMe, VARL, %BLST,

%Me, %Le, %VL
DFLT (B)
BASO, %B
BASO, %B
DFLT (LB)
BASO, LYM, %B, %L
BASO, LYMe, VARL, %B, %Le, %VL
MCHC
RBC, HGB, HCT, MCV, MCH, MCHC,

RDW, PLT, MPV
RBC, HGB, HCT, MCV, MCH, MCHC,

RDW, PLT, MPV, PDW, PCT
LRI
PLT, MPV
PLT, MPV, PCT, PDW
URI
PLT, MPV
PLT, MPV, PCT, PDW
LURI
PLT, MPV
PLT, MPV, PCT, PDW
3-30
CBC + NOC or CBC +RRBC Test Selection invalidates additional parameters with an MCHC Suspect
Parameter Flag.
Section 3
Table 3.4
Parameters Marked With an Asterisk (*) (Continued)
Instrument and
Data Invalidating
Alerts

on Chartable Page

Sampling error
Incomplete
Aspiration
All Parameters
All Parameters
WOC Heater Error
WBC (If WOC is chosen), NEU, MONO,

EOS, BASO, LYM, %N, %M, %E, %B, %L,
%R, RETC
NOTE: WBC and WOC are asterisked for
all cases except for runs with a
Specimen Type of Patient and the
CBC + NOC Test Selection, where
the WBC value always comes
from the NOC.
WBC (If WOC is chosen) SEG, BAND,

IG, BLST, MONe, EOS, BASO, LYMe,
VARL, %Se, %BD, %IG, %BL, %Me,
%E, %B, %Le, %VL, %R, RETC
NOTE: WBC and WOC are asterisked
for all cases except for runs with
a Specimen Type of Patient and
the CBC + NOC Test Selection,
where the WBC value always
comes from the NOC.
HGB Heater Error
HGB, MCH, MCHC
HGB, MCH, MCHC
Reticulocyte
Instrument and
Data Invalidating
Alerts

on Chartable Page

Fragile RBC
%R, RETC
%R, RETC
Too Few Events
%R, RETC
%R, RETC
ERL
%R, RETC
%R, RETC
Flow Error
%R, RETC
%R, RETC
Table 3.5
Parameters with Suppressed Results

Parameters with suppressed results on
Chartable Page
Parameters with suppressed results

on Lab Page
WOC Flow Error
WBC (If WOC is chosen), NEU, MONO,

EOS, BASO, LYM, %N, %M, %E, %B, %L
WBC (If WOC is chosen), SEG, BAND,

IG, BLST, MONe, EOS BASO, LYMe,
%E, %B, %Le, %VL
RBC Flow Error
RBC, MCH, HCT, MCHC, PLT, MPV, MCV,

RDW
RBC, MCH, HCT, MCHC, PLT, MPV,

PCT, PDW, MCV, RDW
NOC Flow Error
WBC (If NOC is chosen), NEU, MONO,

EOS, BASO, LYM, %N, %M, %E, %B, %L
WBC (If NOC is chosen), SEG, BAND,

IG, BLST, MONe, EOS, BASO, LYMe,
%E, %B, %Le, %VL
System Errors
3-31
Section 3

These alerts are triggered by the numeric limits entered into the Patient Sample
Setup Limit Sets (see Section 2: Installation Procedures and Special
Requirements, Subsection: Patient Sample Setup...) or taken from the
instruments preset linearity limits. If results for a parameter exceed these limits,
they are flagged on the screen and on the report. Dispersional alerts are displayed
or printed as follows:
Screen display:
Result below lower limit shown in yellow

Result above upper limit shown in purple
Linearity Exceeded: Result displayed as >>>>
NOTE: When the WBC result exceeds the linearity (>>>>) the HGB result is
displayed as <<<< to indicate possible interference with the HGB due to
the elevated WBC result.
Graphic Report:
Results outside limits are underlined
Specimens with results that exceed the linearity should be diluted with Diluent/
Sheath according to the laboratorys procedure and repeated. (Be sure to correct the
results for the dilution factor used.)
NOTE: MCV, MCH, MCHC and MPV are unaffected by dilution and do not
require correction.
Suspect Parameter Flags

These flags are generated after the instrument evaluates the measured data for a
particular parameter or group of parameters. The result may be suspect due to
interfering substances or the inability of the instrument to measure a particular
parameter due to a sample abnormality.
A higher incidence of false positive morphological flags may be evident on
specimens run at higher ambient temperatures within the operating range, 15C
30C (59F 86F). The numerical reportable results are not affected.
Introduction to WBC Flagging
These are the WBC parameter flags: WBC, DFLT (NLMEB), DFLT (NE), DFLT
(LM), DFLT (B), and DFLT (LB). The following WBC population flags may be
displayed: NWBC, FWBC, NRBC, RRBC, BAND, IG, BLAST, VAR LYM. If any
of the WBC population or parameter flags is displayed, the message SUSPECT is
displayed to the right of the Limits field on the Run View. This message also
appears on printouts.
WBC Descriptors
The WBC Descriptors (WOC and NOC) are included on the display screen and
printout to provide additional information about the reported WBC value. If there
is a clinically significant difference between the two results in the CBC+RRBC test
selection, the instrument will select the appropriate result and display a descriptor
in parentheses next to the WBC value.
NOTE: In the CBC+NOC test selection, the NOC value is always selected.
3-32
Section 3
Data Flagging
This section presents the different data descriptors/flagging that can be displayed
when patient specimens are run in the:
CBC test selection
CBC+RRBC test selection
CBC+NOC test selection
3-33
Section 3
Table 3.6
Patient Specimen Type + CBC Test Selection

Descriptor/
Flag
Cause
Suggested Action
NWBC
When cellular debris interference is high

and there is no declining WOC kinetic rate.
A. Review smear for platelet clumps, giant

platelets or low levels of NRBC and follow your
laboratorys review criteria.
B. If no other suspect parameter flags are present,
the WBC and differential may be reported.
WBC
NRBC/RRBC
Cellular debris interference is high and a

declining WOC kinetic rate is detected.
A. Repeat in CBC+RRBC test selection.

B. If flag persists, review a smear for presence of
NRBC and verify Lymph value. Confirm WBC
count by alternate method.
WBC
VAR LYMPH
FWBC
DFLT (NLMEB)
1. Cellular debris interference is low but a

declining WOC kinetic rate is detected.
2. Cellular debris interference is low and
there is no declining WOC kinetic rate, but
WOC>4.1 x 10e3/L and LYM%>80%.
A. Repeat in CBC+NOC test selection. NOC

result will be reported as WBC result.
B. Review smear to confirm lymph count and
presence of fragile WBC.
DFLT(NLMEB)*
One or more of the following conditions are

true:
1. Fragile cells may be present. (When the
FWBC flag is triggered, DFLT (NLMEB) flag
is always set.)
2. An abnormally low number of cells
available to calculate differential.
3. The mono-poly cut has too much
interference.
NOTE: These are the different DFLT flags:
(NLMEB), (NE), (LM), (B), and
(LB).
(N=Neutrophils, L=Lymphocytes,
M=Monocytes, E=Eosinophils,
B=Basophils)
A. If the DFLT (NLMEB) flag is accompanied with

the FWBC flag, repeat in CBC+NOC test
selection.
B. Review scatterplot for clear separation of cell
cluster.
C. Review a stained smear to verify the
differential values.
DFLT (NE)*
or DFLT (LM)*
or DFLT (B)*
or DFLT (LB)*
The letters in parentheses indicate which

WBC subpopulation or group of
subpopulations is suspect. The DFLT flag
may be due to the presence of abnormal cell
clusters so the instrument cannot reliably
discriminate among WBC subpopulations.
Thus, a default threshold is selected.
A. Review scatterplot for clear separation of cell

cluster.
B. Review a stained smear to verify the
differential values.
MCHC
MCHC <24 g/dL or 40 >g/dL
Verify that the specimen was properly mixed by

following your laboratorys protocol for flagged
RBC indices.
* These flags are also triggered in the CBC+NOC and CBC+RRBC test selections when there is no significant
difference between WOC and NOC.
3-34
Section 3
Table 3.6
Patient Specimen Type + CBC Test Selection (Continued)

Descriptor/
Flag
Cause
Suggested Action
BAND*
The BAND flag is triggered if any of the

following conditions are met:
1. The CV of the neutrophil cluster on the
0 axis exceeds expected criteria.
2. %BAND > 12.5% of the total WBC
count.
3. The ratio of suspected bands to mature
neutrophils is >50%.
Review a stained smear for the presence of

bands and follow your laboratorys review
criteria.
NOTE: When bands are present, they are
included in the total neutrophil count.
IG*
The IG flag is triggered if the following

condition is met:
%IG 3% of the total WBC count

immature granulocytes and follow your
laboratorys review criteria.
NOTE: When IGs are present, they are included
in the total neutrophil count.
BLAST*
The BLAST flag is triggered if any of the

following conditions are met:
1. %Blast > 1% of the total WBC count

blasts and follow your laboratorys review criteria.
NOTE: When blasts are present, they are
included in the monocyte count.
VAR LYM*
1. When the FWBC flag is triggered,

VAR LYM flag is always set.
2. Any of the following attributes fail to meet
expected criteria:
a. Position of the lymphocyte cluster on the
scatter plot.
b. Ratio between lymphocytes and other
WBC subpopulations
c. Lymphocyte count (absolute or %)

variant lymphocytes and follow your laboratorys
review criteria.
NOTE: When variant lymphocytes are present,
they are included in the lymphocyte
count.
NOTE: This flag may be displayed singly or in
combination with the blast flag. If the flag
is displayed with the blast flag, it is
displayed as VLYM/BLAST.
RBC MORPH*
One or more of the following parameters

exceeds expected limits:
MCH < 25pg or >34pg
MCHC < 29g/dL or >37g/dL
RDW >18.5%
1. Review a stained smear for abnormal RBC or

PLT morphology and follow your laboratory's
review criteria.
2. If NRBC or RRBCs are suspected to be
present, run the specimen in the CBC+RRBC test
selection.
* These flags are also triggered in the CBC+NOC and CBC+RRBC test selections when there is no significant
3-35
Section 3
Table 3.6
Patient Specimen Type + CBC Test Selection (Continued)

Descriptor/
Flag
Cause
Suggested Action
LRI*
1. Interference in the lower threshold region

(2fL3fL) > 25% of PLT count.
2. Too much interference between noise
region and PLT population.
3. Too much noise in the 0-low threshold
region.
NOTE: LRI may be caused by:
Debris
Contaminated reagent
Microbubbles
Dirty Diluent/Sheath filter
A. Repeat the specimen. If the flag persists,

review a smear and verify the platelet count.
B. If the flag persists on subsequent samples,
check the platelet background count. If the
background count exceeds the specification,
troubleshoot accordingly.
URI*
1. Interference in the upper threshold region

(1535fL) > 25% of PLT peak.
2. PLT aggregate count (PLT clumps)
> 15% of PLT count.
NOTE: URI may be caused by:
Microcytic RBC
Schistocytes
Giant Platelets
Sickle Cells
Platelet Clumps
A. Review MCV, platelet histogram and

scatterplot.
B. If the scatterplot shows overlap in the RBC or
platelet populations or a population is present
above the platelet scatter, review a smear to
determine the cause and confirm the platelet
count.
LURI*
Interference is present in both the upper

and lower regions of the PLT histogram.
Same actions as for LRI and URI
NO MPV*
MPV < 3.5 fL

PLT has an abnormal distribution
Repeat the specimen. If the MPV data is

suppressed, review the smear for abnormal
platelet morphology and platelet aggregates and
follow your laboratorys review criteria. Verify the
platelet count.
ATYPDEP*
Atypical depolarization events detected in

the lobularity (90), granularity (90
depolarizing) scatter data with cross check
done using size (0) and complexity (10)
scatter data.
Review a stained blood film to detect a possible

morphologic correlate (situation), and follow your
laboratory's review criteria.
See also Section 2: Installation Procedures
and Special Requirements, Subsection: Flag
Setting.
* These flags are also triggered in the CBC+NOC and CBC+RRBC test selection when there is no significant
3-36
Section 3
Table 3.7
Patient Specimen Type + CBC+RRBC Test Selection

Patient Specimen Type + CBC+RRBC Test Selection
Descriptor/Flag
Cause
Suggested Action
(NOC)
WBC
RRBC/NRBC
DFLT (NLMEB)
WOC > NOC in the Resistant RBC cycle

(NOC is selected as WBC count.)
NOTE: Higher WOC is due to unlysed
RRBCs, such as target cells and
sickle cells. Lymphocyte count is
corrected by adding the
difference between WOC and
NOC to the lymphocyte count.
A. Review a stained smear to determine the

cause of the interference such as (NRBC) and
confirm the lymphocyte result.
B. If NRBCs are present, quantify them
according to your laboratorys procedure. If
correction of the WBC is required, correct the
NOC value and use the resultant number to
confirm the WOC result. If no other Suspect
Parameter flags are present, the corrected
NOC (or confirmed WOC) value is reportable.
C. If lytic-resistant RBCs are present, follow
your laboratorys procedure for reporting the
results.
(WOC)
WBC
RRBC/NRBC
NOC > WOC and high stroma

interference in the Resistant RBC cycle
(WOC is selected as WBC count.)
A. Review a stained smear to determine the

cause of the interference (NRBC and/or
unlysed RRBCs).
(WOC)
WBC
NRBC
NOC >WOC, low stroma interference,

A. Review a stained smear for the presence of
and %L<60% in the Resistant RBC cycle NRBCs.
(WOC is selected as WBC count.)
(NOC)
WBC
FWBC
VAR LYM
DFLT (NLMEB)
NOC>WOC, low stroma interference,

and %L>60% in the Resistant RBC
cycle.
(NOC is selected as WBC count.)
NOTE: Lymphocyte count is corrected
by adding the difference
between WOC and NOC to the
lymphocyte count.
Review a stained smear and follow your

laboratorys procedure to confirm the
lymphocyte count, the reported WBC and the
presence of fragile WBCs.
NOTE: See Table 3.6 for additional flags that may trigger with this test selection when there is no significant
3-37
Section 3
Table 3.8
Patient Specimen Type + CBC+NOC Test Selection

Patient Specimen Type + CBC+NOC Test Selection
Descriptor/Flag
(NOC)
FWBC
DFLT (NLMEB)
VAR LYM
Cause
In the CBC+NOC test selection, the
FWBC and VAR LYM flags are always
displayed along with the DFLT (NLMEB)
flag.
(NOC is selected as WBC Count.)
Suggested Action
Review smear to confirm Lymph count and
presence of fragile WBC.
NOTE: See Table 3.6 for additional flags that may trigger with this test selection when there is no significant
NOTE: When processing samples in the CBC+RRBC or CBC+NOC test selections, a correction to the
Lymphocyte count may be performed. If during this correction the differential does not meet software
criteria the differential will be suppressed.
3-38
Section 3
Interpretive Messages
Interpretive messages appear only on the graphics report and are generated when the
numeric limits entered in the Patient Limit Sets are exceeded. See
Subsection: Patient Sample Setup.... These messages are printed only when the
Interpretive Report option is selected on the Setup, Customize Printed Report dialog
box. The Interpretive messages are summarized below.
WBC Messages
Message
Cause
Leukopenia
result exceeds the lower limit for WBC
Leukocytosis
result exceeds the upper limit for WBC
Neutropenia
result exceeds the lower limit for Neutrophil absolute

number
Neutrophilia
result exceeds the upper limit for Neutrophil absolute

number
Lymphopenia
result exceeds the lower limit for Lymphocyte

absolute number
Lymphocytosis
result exceeds the upper limit for Lymphocyte

absolute number
Monocytosis
result exceeds the upper limit for Monocyte absolute

number
Eosinophilia
result exceeds the upper limit for Eosinophil absolute

number
Basophilia
result exceeds the upper limit for Basophil absolute number
RBC Messages
Message
Anemia
result exceeds the lower limit for RBC
Polycythemia
result exceeds the upper limit for RBC
Microcytic RBC
result exceeds the lower limit for MCV
Macrocytic RBC
result exceeds the upper limit for MCV
Hypochromic
result exceeds the lower limit for MCHC
Hyperchromic
result exceeds the upper limit for MCHC
Anisocytosis
result exceeds the upper limit for RDW
Cause
3-39
Section 3
PLT Messages
Message
3-40
Cause
Thrombocytopenia
result exceeds the lower limit for PLT
Thrombocytosis
result exceeds the upper limit for PLT
Microcytic PLT
result exceeds the lower limit for MPV
Macrocytic PLT
result exceeds the upper limit for MPV
Section 3
References
1. Clinical Applications of Flow Cytometry, ASCP National Meeting, Spring
1990.
2. Shapiro, Howard, Practical Flow Cytometry, 1984.
3-41
Section 3
References
NOTES
3-42
Section 4 Performance Characteristics and Specifications
Section 4
Overview
This section presents the various specifications and performance characteristics of
the CELL-DYN Ruby. In particular, the following are discussed:
Specifications
Physical Specifications
Power Specifications
Environmental Specifications
Operational Specifications
Bar Code Specifications
Performance Specifications
This section does not describe the limitations of the System. For this information,
refer to Section 7: Operational Precautions and Limitations.
4-1

Section 4
Overview
NOTES
4-2
Section 4
Specifications
Physical Specifications
Physical specifications for the CELL-DYN Ruby are provided in the following
table.
Table 4.1
CELL-DYN Ruby Physical Specifications

Module
Analyzer
Printers
Height
Width
Depth
Weight
49.9 cm
(19.25 in.)
86.4 cm
(34.0 in.)
76.8 cm
(30.25 in.)
105.2 kg
(232.0 lbs.)
Refer to the printer manufacturers specifications.
Power Specifications
The power specifications for the CELL-DYN Ruby are described in the following
tables. Refer to the power specifications applicable in your country.
Table 4.2
CELL-DYN Ruby Power Specifications
Module
Voltage
Frequency
Max Current
BTU/Hr
Analyzer
100 - 240 VAC
50/60 Hz
5.0 - 2.2 amps
550 watts
Display
100 - 240 VAC
50/60 Hz
1.5 amps
50 watts
Printer
For power specifications for printers, refer to the operators manual for your printer or
other documentation received with your printer.
Table 4.3
CELL-DYN Ruby Fuse Specifications

Module
Analyzer
Fuse Rating
Internal fuses only. Not operator replaceable.
4-3

Section 4
Specifications
Environmental Specifications
Environmental specifications include the operating environment required by the
CELL-DYN Ruby, the clearance and waste disposal requirements, and the noise
level and heat output that can be expected during normal operation.
Operating Environment Requirements

Temperature:
15C30C (59F86F)
Relative Humidity:
(non-condensing)
Indoor Use
< 80%
To ensure proper service access and ventilation, provide the CELL-DYN Ruby
with the clearances shown in the following table.
Table 4.4
Unit
Analyzer
Table 4.5
Above
Behind
Left
Right
15.2 cm
(6 in.)
15.2 cm
(6 in.)
15.2 cm
(6 in.)
15.2 cm
(6 in.)
Clearance Requirements for Service Access

Unit
Analyzer
Above
Behind
Left
Right
30.5 cm
(12 in.)
15.2 cm
(6 in.)
40.6 cm
(16 in.)
40.6 cm
(16 in.)

All waste produced by the CELL-DYN Ruby must be disposed of according to
local, state, and federal regulations governing the treatment and disposal of
medical waste. Label all waste containers as biohazardous waste.
Operating Noise Level and Heat Output

The CELL-DYN Ruby produces a certain amount of noise and heat as a normal
part of operation. The following levels of noise and heat can be expected:
Noise Level:
Idle Mode
< 60 db
Running Mode < 65 db
Heat Output:
0.6 kW maximum (2000 BTU)
Transport and Storage

There are no specific environmental conditions for transport or storage.
4-4
Section 4
Operational Specifications
Maximum Throughput (Closed Mode)
CBC:
84 specimens/hr
Maximum Throughput (Open Mode)

CBC:
76 specimens/hr
Complete Cycle Times

Auto-start up (from standby)
7-13 minutes
Run, Open Mode (CBC)
< 52 seconds
Run, Sample Loader (CBC)
< 45 seconds
Nominal Aspiration Volume

Closed Mode:
< 230 L
Open Mode:
< 150 L
Recommended Anticoagulants
All performance claims given in this manual were generated using specimens
collected in K2EDTA. Results may be affected by the use of other anticoagulants.
Specimen Tube Dimensions (Closed Mode)

Table 4.6
Recommended Collection Tube Dimensions for use in Closed mode

Collection Tube Dimensions
11.5-13 mm diameter x 65-75 mm long
Rack
Refer to Appendix A: Parts and
Accessories for rack information.
When all specimens are run with this test selection.
4-5

Section 4
Specifications
Recommended Specimen Collection Tubes (Closed Mode)

CAUTION: The tubes listed in the following table are only listed to
address physical compatibility and are not recommended based on analytic
performance.
Table 4.7
Recommended Specimen Collection Tubes for use in Closed Mode
Brand
Specified Tube
Dimensions
Maximum Tube
Draw Volume
Specified Tube
Closure
Specified Tube
Type
Becton Dickinson
Vacutainer
13 mm diameter x
75 mm long
5.0 mL
Conventional or
Hemogard
Glass
or
Plastic
Greiner
Vacuette
13 mm diameter x
75 mm long
4.0 mL
None
Plastic
Sarstedt
S-Monovette
13 mm diameter x
65 mm long
or
11.5 mm diameter x
66 mm long
2.6 mL
None
Plastic
13 mm diameter x
75 mm long
5.0 mL
None
Glass or Plastic or
PET
Terumo
Venoject
Venosafe
2.7 mL
Recommended Volume Requirements in Specimen Collection Tube

Closed Mode:
Minimum Specimen Volume > 1.2 mL
NOTE: Follow the collection tube manufacturers recommendation for minimum
volume in specimen tubes.
Open Mode:
Minimum Specimen Volume > 0.5 mL (500L)
NOTE: 0.18 mL (180 L) - In Micro-Specimen Collection Tubes
(Non-vacuum)
NOTE: Follow the collection tube manufacturers recommendation for minimum
volume in specimen tubes.
4-6
Section 4
Bar Code Specifications

Specification for Bar Code Symbols, Bar Code Labels, and their Placement
Bar code symbols, labels, and their placement must meet the following
specifications to be used with the CELL-DYN Ruby System.
Symbology:
Code 39
Interleaved 2 of 5
Codabar
Code 128
All CELL-DYN Ruby-compatible symbologies have Character SelfChecking.
Symbol Dimensions:
Length of the Bar Code Symbol (see the following figure):
Maximum Bar Code Symbol Length: 41mm (1.6 in.)
Minimum length of Quiet Zone at each end: 5mm (0.2 in.)
NOTE: A maximum Bar Code Label length of 51mm (2.0 in.) includes
the required minimum Quiet Zone of 5mm (0.2 in.) at each end
of the symbol.
Height of the Bar Code Symbol (see the following figure):
Minimum Bar Code Symbol Height: 12.7mm (0.5 in.)
Figure 4.1
Bar Code Symbol Dimensions & Label Requirements
4-7

Section 4
Specifications
Bar Code Label:

Label Orientation: Place the label with the bars perpendicular to the axis of
the tube. See Figure 4.2.
Label Size:
Maximum label length: 51mm (2.0 in.)
Maximum label width: 31.8mm (1.25 in.)
Print Quality of Measurement:
Minimum printer resolution: 200dpi (dots per inch)
Reflective contrast between bars and label background: >70%
Density: Low or Medium
Symbol Grade: Minimum of C as defined by ANSI X3. 182-1990
Module Dimension (Narrow Element Dimension):
The width of the narrowest element in a bar code: 0.25mm (0.01 in.)
Data Content:
Bar Code Symbology Characters
CAUTION: DO NOT use the following characters for Specimen
Identification: | , \ , ^ , and &. These characters will cause the Specimen ID
to be truncated at the point where the character is located within the ID. This
action will result in an erroneous Specimen ID for the downloaded Pending
Order entry or for the record received by the LIS, without any error
notification.
Table 4.8
Characteristics of the Bar Code Symbologies Supported by the CELL-DYN Ruby
Bar Code Symbology Name
Elements per Character
Characters*
Code 39
Each character has 9 elements:

5 bars and 4 spaces
Alphanumeric characters:
A-Z, 0-9, <space>, $ - . / + %
Interleaved 2 of 5
Each character (2 digits) has 10

elements: 5 bars and 5 spaces
Numeric characters:
0-9
Codabar

4 bars and 3 spaces
Numeric characters:
0-9 , and $ - . / + :
Code 128

3 bars and 3 spaces
All 128 ASCII characters and all 128

extended ASCII characters
* Do
4-8
not use these character for specimen identification: | , \ , ^ , and &.
Section 4
Bar Code Label Placement:

A Bar Code Symbol including Quiet Zone should be placed at least 8mm
(0.31 in.) from the bottom of the tube and within the following label
placement zone on a specimen tube to be sensed by the tube sensor(s) and to
be read by the Bar Code Reader in the Closed Mode, see the following two
figures.
Figure 4.2
Bar Code Label Placement Requirements
59
Figure 4.3
Tube with Correctly Positioned Bar Code Label in a Sample Loader

Rack
4-9

Specifications
Section 4
CAUTION: To prevent potential bar code reading errors or a sample

identification that can be mistaken for another Sample ID:
Use the bar code symbology Code 128 specified by the Clinical and
Laboratory Standards Institute CLSI.1
Verify that laboratory generated bar code labels and label placement follow
the specifications listed in this section.
Good Laboratory practice mandates that each specimen is labeled with
information traceable to one patient only. Therefore, it is recommended that
only one bar code label is used on each tube for correct specimen
identification.
4-10
Section 4
Performance Specifications
The following performance specifications apply to systems that have been installed
and maintained according to the guidelines in this manual and are operated with the
recommended reagents and supplies. Specifications listed apply to all modes and
test selections. System performance is expected to meet or exceed the
specifications listed.
Background
Background concentrations represent apparent sample-related constituents that
actually originate from blood-free reagents and/or electronic noise. The
background concentrations are used to confirm the Systems baseline performance,
where no actual sample is aspirated. The following table lists acceptable
background concentration limits that must be met before using the instrument.
Table 4.9
Background Limits
Parameter
Background Concentration Limits
WBC (WOC and NOC)
<0.10 x 103/L
RBC
<0.02 x 106/L
HGB
<0.10 g/dL
PLT
<5.00 x 103/L
RETC
<100 counts
Results are expressed in traditional US Units.
Carryover
Carryover is defined by CLSI EP10-A22 as the discrete amount of analyte carried
by the measuring system from one sample reaction into subsequent sample
reactions, thereby erroneously affecting the apparent amounts in subsequent
samples. It is expressed as either a percent or an absolute effect of one sample
upon succeeding analysis. For hematology instruments, carryover generally causes
a positive bias on the results for the succeeding sample.
4-11

Section 4
Specifications
CBC Parameters
The specific parameters tested for carryover were WBC (WOC and NOC), RBC,
HGB and PLT. Whole blood specimens with high target values were processed in
triplicate, followed by three aspirations of whole blood specimens with low target
values. Carryover is calculated and expressed as a percentage using the following
formula per the ICSH3:
% Carryover =
Table 4.10
Low Target Value - Low Target Value

X 100
( High
Target Value - Low Target Value )
1
Carryover
Parameter
Target Values
(USA)
% Carryover
Low Value
High Value
WBC
(WOC and NOC)
0.05 x 103/L
128 x 103/L
<1%
RBC
0.00 x 106/L
7.34 x 106/L
<1.2%
HGB
0.01 x g/dL
24g/dL
<1%
PLT
0.00 x 103/L
2976 x 103/L
<1.7%
Manipulation of fresh whole blood was needed to generate the pathologically elevated
or depressed concentrations shown in this Table. Results are expressed in traditional
USA units.
As a matter of convenience, many laboratories compare a normal value specimen

followed by an aspiration of air to calculate background.
Reticulocyte % measurement carryover, as shown in Table 4.11 is calculated using
actual Listmode counts, rather than using the Reticulocyte percent. It is calculated
using the following formula:
Background1 - Background3
X 100
Retic Listmode3 - Background Count3
Reticulocyte carryover is determined on fresh blood samples with RBC in the
range of 4.0-6.0 M/L. Retic Background count is reported on the Retic Run
Results Screen, while Retic Listmode can be found in DIAGNOSTICS---> RETIC
RAW DATA.
% Carryover =
Table 4.11
4-12
Reticulocyte Carryover
Parameter
Specimen Range
% Carryover
RETIC %
0.9 - 1.6%
<1%
Section 4
Imprecision (Reproducibility)
Imprecision is the standard deviation (SD) or coefficient of variation (%CV) of
analytic results in a set of replicate measurements. Fresh whole blood specimens
used to verify imprecision specifications should have mean values that fall within
the range tested in the following table and should not display any Suspect
Parameter flags for the measurand (parameter) studied.
The following data were derived from multiple fresh normal blood imprecision
runs (n=31 replicates/run) performed on 3 analyzers in various test selections and
modes during the Abbott Hematology medical-clinical validation study.
Table 4.12
Fresh Blood Imprecision

Upper Confidence LimitsC
Parameter
Ranges TestedA
Observed % CV
RangeB
95 %
97.5 %
99 %
WBC (WOC)
4.4 9.5 X 103/L
1.2 2.7
2.4
2.5
2.7
WBC (NOC)
4.4 9.4 X 103/L
1.2 - 3.1
2.8
3.0
3.3
RBC
4.52 5.72 X 106/L
0.6 1.8
1.8
1.9
2.1
HGB
13.4 16.9 g/dL
0.3 1.8
1.4
1.5
1.7
HCT
40.1 - 51.6 %
0.6 1.9
1.8
1.9
2.1
MCV
82.5 97.3 fL
0.2 0.8
0.8
0.8
0.9
RDW
10.6 13.2 %
0.8 1.6
1.5
1.6
1.7
PLT
168 371 X 103/L
1.7 3.9
3.8
4.0
4.3
MPV
5.4 9.9 fL
2.4 7.1
6.2
6.6
7.1
RETC
1.2 1.8 %
8.1 12.3
13.9D
15.0D
16.5D
NEU
46.1 69.1 %
0.7 1.7
1.8
1.9
2.0
LYM
22.3 42.6 %
1.7 3.4
3.3
3.5
3.7
MONO
4.5 9.4 %
4.3 12.0
11.0D
11.9D
13.1D
EOS
0.6 7.0 %
5.0 20.1
21.2D
23.2D
25.8D
BAS0
0.5 1.6 %
10.1 23.1
23.3D
24.8D
26.7D
Expected Failure Frequency For Statistical Reasons Alone:
1 in 20
1 in 40
1 in 100
A
B
C
D
Results are expressed in traditional US units. These ranges do not represent globally applicable reference intervals, but reflect normal ambulatory adults in the validation study. Each laboratory should establish/verify its own reference intervals.
These are the minimum and maximum imprecision values observed for up to 39 imprecision runs with n=31 replicates.
Each column represents the maximum imprecision (%CV) expected for this entire data set. The frequency statements at the
bottom of each column represent how often a higher %CV is expected for statistical reasons alone.
Higher values than the other measurands are expected because of lower numbers of reticulocytes, monocytes, eosinophils,
and basophils in normal blood. This table format is used to simplify comparisons of achieved %CV for all measurands on
an analyzer undergoing evaluation.
4-13

Section 4
Specifications
Laboratories should confirm this imprecision performance, using fresh whole blood
specimens within the ranges shown above. Specimens with values outside these
ranges may have higher or lower %CV, in part based on binomial distributions and
Poisson statistics that govern particle counting. If a laboratory uses a different
number of replicates than n=31, a statistical comparability test must be performed for
different sample sizes, such as the chi-squared method described in CLSI EP5-A2.
Analytical Measurement Range (AMR)

This represents the range over which the system will yield accurate results. The
analytical measurement range (AMR) specifications in the following table were
determined by analyzing dilutions and concentrations of fresh human whole blood,
supplemented with commercial material. Only samples without invalidating or suspect
flags for the parameter studied were used. The stated limits were determined by
regression analysis using a statistical process method evaluation based on CLSI EP6-A.
Table 4.13
Analytical Measurement Range
Parameter
Display Range
AMR
UnitsA
WBC
0.00 246
0.02 246.8
X 103/L
RBC
0.00 7.50
0.00 7.50
X 106/L
HGB
0.00 25.0
0.0 25.0
g/dL
HCT
0.00 99.5
8.3 79.8
MCV
0.00 139
58 139
fL
RDW
0.00 29.8
10.0 29.8
PLT
0.00 3000
0.00 3000
X 103/L
MPV
0.00 17.2
4.3 17.2
fL
RETC
0.00 23.0
0.2 22.9
Results are expressed in traditional U.S. units
In order to extend the MCV lower limit beyond that encountered in the Abbott
medical-clinical studies, various animal bloods were compared to a reference
MCV derived from a centrifugal microhematocrit and a CELL-DYN Sapphire
reference RBC concentration, with the following expanded range:
MCV: 38.3 63.5 fL
Patient specimen values beyond the upper limit of the AMR should be established
by dilution and re-assay, while specimen values beyond the lower limit of the AMR
(as applicable) should be established by alternate methods in accordance with
laboratory policy.
4-14
Section 4
Comparability (Correlation)
Results from five CELL-DYN Ruby systems were compared with five
CELL-DYN Sapphire hematology analyzers for principal comparability purposes.
Additional comparisons of the WBC differential were made to microscopy. These
results represent typical performance achieved during Abbotts medical-clinical
validation studies. The results in individual laboratories may vary from these data.
Table 4.14
Comparability (Correlation) of CBC and Differential to CELL-DYN Sapphire
Parameter
Range TestedA
Replicates
r-valueB
Slope
Y - Intercept
WBC
0.02 212 X 103/L
2,635
0.998
1.03
-0.05
RBC
1.47 7.84 X 106/L
2,668
0.995
0.99
+0.04
HGB
4.5 23.8 g/dL
2,735
0.997
1.01
-0.10
HCT
29.6 60.0 %
2,306
0.988
1.00
+0.40
MCV
71 118 fL
2,665
0.965
0.96
+4.74
RDW
10 30 %
2,688
0.942
0.97
+0.46
PLT
23 1993 X 103/L
2,453
0.996
0.98
+6.39
MPV
4 17 fL
2,441
0.823
1.28
-2.01
RETC
0.2 4.9 %
605
0.822
0.69
+0.37
NEU
18 97 %
2,273
0.995
0.99
+1.01
LYM
1 75 %
2,273
0.992
0.98
-0.12
MONO
0 30 %
2,273
0.930
0.93
+0.66
EOS
0 12 %
2,273
0.969
1.02
-0.18
BASO
05%
2,273
0.624
0.81
+0.46
A
B
Results are expressed in traditional US units. These values do not represent the analytical measurement range, which is
provided in another table.
Correlation coefficient, established by Passing-Bablok regression analysis, except for BASO, which was analyzed by
orthogonal regression analysis.
4-15

Section 4
Specifications
Table 4.15
Comparability (Correlation) of WBC Differential to Microscopy
Parameter
Range TestedA
Replicates
r-valueB
Slope
Y - Intercept
NEU
7 95%
113
0.983
0.97
-1.98
LYM
1 72%
113
0.921
0.95
+0.94
MONO
3 69%
113
0.711
1.10
+1.93
EOS
0 20%
113
0.952
1.04
+0.01
BASO
0 10%
113
0.146
0.18
+1.22
A
B
4-16
Results are expressed in traditional US units. These values do not represent the analytical measurement range, which is
provided in another table.
Correlation coefficient, established by Passing-Bablok regression analysis, except for BASO, which was analyzed by
orthogonal regression analysis.
Section 4
References
1. Clinical and Laboratory Standards Institute/NCCLS. Evaluation of the Linearity
of Quantitative Measurement Procedures; a Statistical Approach; Approved
Guideline. CLSI/NCCLS document EP6-A [ISBN 1-56238-498-8] Clinical and
Laboratory Standards Institute/NCCLS, 940 West Valley Road, Suite 1400,
Wayne, PA, 2003.
2. Clinical and Laboratory Standards Institute/NCCLS. Evaluation of Precision
Performance of Quantitative Measurement Methods; Approved Guideline
Second Edition. CLSI/NCCLS document EP5-A2 [ISBN 1-56238-542-9]
Clinical and Laboratory Standards Institute/NCCLS, 940 West Valley Road,
Suite 1400, Wayne, PA, 2004.
4-17

Section 4
References
NOTES
4-18
Section 5 Operating Instructions
Section 5
Overview
The CELL-DYN Ruby System accommodates many laboratory environments and
workflow. Before attempting to operate the system, you should be familiar with the
hardware components of your system and the fundamental principles of the
software user interface. See Section 1: Use or Function.
This section presents the information necessary to perform the day-to-day
operation of the CELL-DYN Ruby. Operating instructions topics include:
System Priming, Interruption, and Standby
Describes how to prime, interrupt, standby, power on, and power off the
system.
Setup Guidelines
Tasks to configure your system.
Specimen Analysis
Provides descriptions of specimen analysis tasks, Orders Management for
specimen processing, and how to initiate processing runs in the Open and
Closed Modes.
Post Analysis Processing
Provides descriptions of the stored results and instructions on how to find,
view, transmit, and print results.
Advanced Data Management
Describes working in the Groups View.
Quality Control ID (QCID) File Setup, control material processing in the
Open Mode, control results analysis and file data management, Westgard
rules, Levey-Jennings graphs, and QC views are described in detail in
5-1
Section 5
Overview
NOTES
5-2
Section 5

Power On and Power Off
1 CD-ROM or DVD
Drive
2 Floppy Drive
3 Data Station Power
Button
4 Main Power Switch
(Rear Panel)
5 Intake Fan
Figure 5.1
4
5
3
2
Power Switch Locations
Power ON Procedure
Leave the System main power switch, located on the back of the Analyzer, ON at
all times. The instrument is designed to maintain itself when it is idle. If the
instrument is idle for four hours, an automatic To Standby cycle is initiated. The
instrument is placed in the Analyzer Status, Standby state at the end of the
automatic cycle.
With the System main power switch in the ON position, the Data Module Power
button (spring-loaded momentary type) is used to power the Analyzer and Display
ON.
The Application Programs shutdown menu option should be used to turn the
Analyzer OFF.
The Display and Printer have their own power switches and should be left ON as
long as the main power switch to the System is ON. Power to the Display and
printer should be turned OFF when the System main power switch is turned OFF,
when a malfunction is suspected, or requested to by an authorized Abbott
representative.
Refer to the printer manufacturers operating instructions for complete instructions
on printer operation.
CAUTION: If the power has been OFF more than five minutes, let the
laser warm up for 15 minutes once the power is turned back ON. Do not
process samples during this warm-up period.
5-3
Section 5
Power On with Main Power Switch in ON Position

Table 5.1
Procedure to Power-up the Instrument When the System Main Power Switch is in ON Position
Task
Power-up
5-4
Step
1. Press and hold (4 seconds), then
release the Data Module power
switch (right side).
2. When the Analyzer Status indicates
Initialized state, press F12 Prime
to prime the system and run an Auto
Background.
NOTE: Verify background count results
are within acceptable limits prior
to running controls or patient
specimens.
Result/Comment
CAUTION: If the power has been
OFF more than five minutes, the
laser must be allowed to warm up
for 15 minutes once the power is
turned back ON. Do not process
samples during this warm-up
period.
Section 5
Power On with Main Power Switch in OFF Position

:
Table 5.2
Procedure to Power-up the Instrument When the System Main Power Switch is in OFF Position
Task
Step
Pre-Power Up Tasks
1. Verify that:
a. All components are properly
installed (syringes, tubing in the
normally closed valves, Shear
Valve, etc.).
b. All reagents are properly installed.
c. All necessary cables and power
cords are properly connected.
d. The Analyzer covers are properly
installed, including the Processor
Cover.
e. If a problem caused the main
power switch to be turned OFF,
verify that the problem has been
corrected.
Turn on the System

and peripherals
2. Turn the System main power switch

(rear panel) to the ON position
followed by:
a. Display
b. Printer
c. Data Module power switch (right
side), press and hold for 4
seconds, then release the Data
Module power switch (right side).
Prime and check

background counts

Initialized state, press F12 Prime
to prime the system and run an Auto
Background.
are within acceptable limits prior
to running controls or patient
specimens.
Result/Comment
CAUTION: If the power has been
OFF more than five minutes, the
laser must be allowed to warm up
for 15 minutes once the power is
turned back ON. Do not process
samples during this warm-up
period.
5-5
Section 5
Power OFF Procedure

It is not necessary to turn the System main power switch OFF under normal
operating conditions. The System main power switch (rear panel) should be turned
OFF when a malfunction is suspected, when instructed or requested to do so by an
Abbott representative, when the system will be moved, or when the system will be
inactive for an extended period of time (greater than 2 weeks). If the system will
be inactive for a longer period of time see the special protocol Section 9: Service
and Maintenance, Subsection: 7009 Prepare for Shipping protocol.
NOTE: In the event of an emergency, turn the System main power switch OFF as
quickly as possible.
Table 5.3
Task
Power off
and reboot
5-6
Procedure to Power Off and Reboot the System

Step
1. With the System main power
switch ON, select File, then
Shutdownfrom the menu bar.
2. Select OK to initiate shutdown.
3. Wait 5-10 seconds after the
display turns black, press and
hold (4 seconds), then release
the Data Module power button
(right side) to reboot the system.
4. When the Analyzer Status
indicates Initialized state, press
F12 Prime to prime the system
and run an Auto Background.
NOTE: Verify background count
results are within
acceptable limits prior to
running controls or patient
specimens.
Result/Comment
1 If analyzer state is READY, shutdown will put
analyzer in standby mode before turning it OFF,
otherwise, analyzer will be turned off without
standby.
2 Analyzer and Data Module are OFF.
Section 5
Power Down and Power Off Main Power Switch

Table 5.4
Procedure to Power-Down the Instrument and Power Off the System Main Power Switch
Task
Power off the main

power switch
Step
Result/Comment
1. With the System main power switch

ON, perform Auto-Clean procedure.
2. When the Auto-Clean cycle is
finished, select To Standby from the
Maintenance, Special Protocols
view.
Standby state, select System
Shutdown from the Maintenance,
Special Protocols view.
4. Wait 5-10 seconds after the display
turns black, then turn the System
main power switch OFF (rear panel)
followed by:
a. Display
b. Printer
Refer to Section 9: Service and

Maintenance, Subsection: Scheduled
Maintenance Procedures.
5-7
Section 5
System Priming
The Analyzer must be primed for specimen analysis. If the CELL-DYN Ruby
Analyzer Status indicates Standby state, the System can be primed in two ways:
F12 Prime
Select the F12 Prime function key to activate prime cycle
and run an AutoBackground.
NOTE: Verify background count results are within
acceptable limits prior to running controls or patient specimens.
Prime task button
Select Prime task button
from the Maintenance,
Special Protocols tab
view to activate prime
cycle and run an AutoBackground.
NOTE: Verify background count results are within acceptable limits prior
to running controls or patient specimens
5-8
Section 5
Interruption Procedures
Sample Loader processing can be interrupted using the following procedures in the
following table. If the Sample Loader halts automatically in response to a System
Information Message, refer to Section 10: Troubleshooting and Diagnostics,
Subsection: System Messages.
Procedural Guidelines
Starting, interrupting and re-starting the loader without changing to Open mode
generates the Sample Loader Resume or Reset dialog box that provides the option
to resume rack processing if the rack was not moved, or to reset the rack to the load
position and begin again.
Starting, interrupting, changing to Open mode and then back to Closed mode, and
re-starting the loader generates the Sample Loader Reset dialog box that prompts
the operator to reset the rack to the load position and begin again.
Table 5.5
Sample Loader Interruption
Task
Step
Interrupt loader and

restart loader
1. Select F12 Stop Loader function key.

2. Select F12 Start Loader function key.
3. If rack under the Processor Cover is not being
removed, select the Resume Loader button in
the Sample Loader Resume or Reset dialog
box to resume loader processing.
If rack under the Processor Cover is being
removed, remove any completed tubes from
the racks, reset the rack to the load position,
select the Reset Loader button in the Sample
Loader Resume or Reset dialog box to
restart loader processing.
Interrupt loader,
change modes, and
then re-start loader
1. Select F12 Stop Loader function key.

2. Select F11 Select Open function key to
change modes and process as necessary.
3. Select F11 Select Closed function key to
change modes.
4. Press the F12-Start Loader function key.
5. Select the Reset Loader button in the Sample
Loader Reset dialog box to begin loader
processing.
5-9
Section 5
Standby
The To Standby Task Button
The System enters the Standby state automatically or on demand. When the
System goes into the Standby state, the following events are automatically
performed:
Fluidics are rinsed and drained
Pinch valves are opened
Laser power is reduced as needed
Vacuum and pressure are vented
Internal timer is set
After four hours of inactivity, the System automatically goes into Standby state.
Once in Standby, the System exercises pinch valves every four hours to unpinch
tubing.
Table 5.6
Procedure to Manually Place the System in Standby State

Task
To Standby
Step
Result/Comment
1. From the Maintenance view select

the Special Protocols tab view.
2. Select the To Standby task button.
The System enters Standby and
records the activity in the System Event
Log with date, time, and operator ID.
5-10
Section 5
Setup Guidelines
Setup Guidelines
The following table summarizes the tasks involved to configure your System to
your laboratorys requirements. See Section 2: Installation Procedures and
Special Requirements, Subsection: System Customization for more details.
Task
Date/Time
Section 2: Installation Procedures and Special

Requirements, Subsection: User Interface
Preferences.
Unit Selection

Requirements, Subsection: Unit Sets Selection.
Bar Code Setup

Requirements, Subsection: Bar Code Setup.
Orders Setup

Requirements, Subsection: Orders Setup.
LIS Setup

Requirements, Subsection: LIS Setup.
Patient Limits

Requirements, Subsection: Patient Sample Setup....
Default Patient Test

Selection

Requirements, Subsection: Patient Sample Setup....
Reagents
Section 9: Service and Maintenance, Subsection:

Reagents View.
QCID Setup
Section 11: Quality Control, Subsection: QCID File

Setup.
Customize Run View

Requirements, Subsection: Customize Run View.
Customize Data View

Requirements, Subsection: Customize Data View.
Customize Printed
Report

Requirements, Subsection: Customize Printed
Report.
For Information, See:
5-11
Section 5
Setup Guidelines
NOTES
5-12
Section 5
Specimen Analysis
The CELL-DYN Ruby offers highly automated specimen analysis. The following
list highlights important features of the specimen analysis process:
Specimens in closed tubes can be processed in the Closed mode, or can be
uncapped and processed in Open Tube mode.
The System obtains specimen processing instructions from the default patient
test selection setup in Patient Sample Setup, Demographics dialog box or,
if there are Pending Orders in the Orders view.
The System obtains instructions from matched entry fields based on
matching orders by bar code ID or not using a bar code ID (match by rack
and tube position).
Processing and Demographics data for each Pending Order entry can be
added manually or downloaded from a Laboratory Information System
(LIS).
Specimen Analysis Tasks

The following table summarizes the tasks involved in specimen analysis and
provides references to other subsections for detailed information.
NOTE: Review the procedures described in Subsection: Preparing to Run
Specimens within this section before analyzing specimens.
Table 5.7
Specimen Analysis Tasks

Task
Verify or Change Default Patient

Test Selection Processing Condition
Subsection: Default Patient Test

Selection Processing Conditions
within this section.
Create Pending Orders
Subsection: Create Manual Orders

Enter Specimen Demographics

Information
Subsection: Create Manual Orders

Routine System Startup
Subsection: Preparing to Run

Specimens within this section.
Run Specimen in Open or Closed

Mode
Subsection: Running Specimens

Review Results
Subsection: Post-Analysis
Processing Datalog View within this
section.
5-13
Section 5
Specimen Analysis
Table 5.7
Specimen Analysis Tasks (Continued)

Task
Reorder Tests

Subsection: Advanced Data
Management Groups View within this
section.
Preparing to Run Specimens

Preparing to Run Specimens
This subsection describes the procedures that are completed in preparation for
specimen analysis. The procedure for running background counts is also described.
Because the exact steps followed can vary depending on the organization of a
laboratory, always follow your laboratorys procedures along with these general
guidelines.
Routine System Startup
The following table provides references to other sections and subsections for use if
detailed information is needed.
Table 5.8
Required Procedures for Specimen Analysis

Task
Comment
Prime the Analyzer.
See Subsection: System Priming, Interruption, and Standby

NOTE: Ensure that background counts are within acceptable limits
before running controls and patient specimens.
Enter, check, or change operator ID.
See Subsection: Operator ID within this section.
Check waste container level, if

applicable.
Empty waste (as needed).
Check reagent levels in Reagents

view.
Replace reagent(s) as needed. See Section 9: Service and

Maintenance, Subsection: Reagents View and Reagent
Container Replacement.
Check for any maintenance due in

Maintenance view.
Perform any required maintenance indicated. See Section 9:

Service and Maintenance, Subsection: Maintenance View.
Check QC Status region.
Review specific QCID Files and moving average programs as

needed. See Section 11: Quality Control, Subsection:
Evaluating and Investigating Commercial and Patient Control
Results.
Verify Background Counts.
See Subsection: Running Background Counts within this

section.
5-14
Specimen Analysis
Section 5
Table 5.8
Required Procedures for Specimen Analysis (Continued)
Prepare, run, and verify controls.
Handle controls as directed on the manufacturers assay sheet. See

Section 11: Quality Control, Subsection: Performing a QC Run.
Verify specimen acceptability for

processing (ID, volume, temperature).
See Subsection: Preparing and Handling Specimens within this

section.
Prepare and run Specimens.
See Subsection: Running Specimens within this section.
Operator ID
Signing On and Off
The operator should perform Operator Sign On to update the Operator ID (OPID)
before running specimens.
The Operator ID is displayed on all screens and printed on the graphics report. It is
also retained in the Datalog, QC View, Reagent Log, Maintenance Log, Calibration
Log and the System Event Log. The operator sign on and sign off area is located in
the upper right-hand area of the view. The Operator ID is selected from the dropdown Menu.
Running Background Counts

Background counts, which are reported in the Datalog, QC View, and the Run
View, are results obtained by performing a QCID Background (normal CBC).
Background counts can be used to confirm that the Systems baseline performance
meets stated performance criteria. For more information on performance criteria,
refer to Section 4: Performance Characteristics and Specifications.
The QCID RETC_Background counts are not part of the QCID Background count
and must be performed separately. AutoBackground counts are performed
automatically by the System after certain routine functions such as Prime and are
reported in the Datalog and Run View.
5-15
Section 5
Specimen Analysis
See Section 10: Troubleshooting and Diagnostics, Subsection: Troubleshooting

Tips and Techniques for information on troubleshooting background counts.
Although the System automatically runs a background count at the end of Prime,
additional Background counts and RETC_Background counts can be run on
demand as follows:
1. In the Next Open Tube Entry region, select the Background from the
Specimen ID or QCID drop down menu.
NOTE: To check the RETC_Background count, verify the Analyzer Status
indicates Ready state, select Retic from the Test Selection menu
to change to Reticulocyte mode. Select RETC_Background from
the Specimen ID or QCID drop down menu.
2. Press the Touch Plate to start the background counting cycle.
3. Ensure that background counts are within acceptable limits before running
controls and patient specimens.
Background counts may be run in Closed mode according to operator preferences.
1. Place a Background QCID barcode label on an empty Vacutainer tube.
2. Put the tube in a Sample Loader rack and place the rack in the load side of the
Sample Loader.
3. Select F12 Start Loader.
4. When processing is complete, verify that background counts are within
acceptable limits before running controls and patient specimens.
NOTE: Background QCID bar code labels are available as an optional accessory.
Refer to Appendix A: Parts and Accessories.
Preparing and Handling Specimens

WARNING: Potential Biohazard. Consider all specimens, reagents,
controls, calibrators, etc., that contain human blood or serum as potentially
infectious. Wear lab coats, protective eye wear, and gloves, and follow
biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Anticoagulant
See Section 4: Performance Characteristics and Specifications, Subsection:
Operational Specifications for information on recommended anticoagulants.
5-16
Specimen Analysis
Section 5
Specimen Stability
Any refrigerated specimens should be brought to room temperature before
processing. If specimens are to be run within eight hours after collection, storage
at room temperature is recommended. If specimens are to be run more than eight
hours after collection, storage at temperatures between 2 and 8 C is
recommended.
Stability studies show that, when specimens are stored at room temperature before
mixing and processing, results for the WBC, RBC, HGB, MCV and PLT are stable
(5.4%) for up to 24 hours after collection. An increase in false-positive Suspect
Population Flags may be seen on samples processed more than 4 hours after
collection time.
The stability of capillary samples may vary depending on the collection device
manufacturer. Refer to the collection tube manufacturers package insert for
stability claims.
Specimen Collection
All specimens should be collected using proper technique and following the tube
manufacturers recommendation.
NOTE: For additional information on collecting venous and capillary samples,
refer to CLSI Standards, H3-A51 and H4-A52.
See Section 4: Performance Characteristics and Specifications, Subsection:
Operational Specifications for information on recommended volume
requirements in specimen collection tubes.
Interfering Substances
It is important to note that there are commonly occurring interfering substances that
can affect the results reported by hematology analyzers. See Section 7:
Operational Precautions and Limitations, Subsection: Interfering Substances
and Conditions.
Specimen Mixing
Proper mixing of specimens prior to sample aspiration is essential for obtaining
accurate results on the CELL-DYN Ruby System. For control or calibrator mixing
instructions, refer to the manufacturers product insert. Specimens stored at
refrigerator temperatures must be brought to room temperature prior to mixing.
Specimens to be run in the Open Mode must be well mixed on a mechanical mixer
or hand mixed by inversion per your laboratorys protocol. Immediately prior to
sample aspiration, mix again by inverting the tube a minimum of 10 times.
For specimens collected in micro-collection devices, refer to the collection tube
manufacturers insert for proper mixing and handling.
The Sample Loader automatically mixes the specimen before aspiration.
5-17
Section 5
Specimen Analysis
Running Specimens
Specimens may be analyzed whenever the Analyzer Status indicates Ready state.
For Open Mode only, when specimens have not been run for one hour or more, a
background should be run immediately prior to running a patient specimen.
Refer to Subsection: Specimen Mixing for proper mixing of specimens prior to
sample aspiration.
NOTE: The Quick Precision Check dialog box should not be opened when
running patient samples. The Quick Precision Check takes precedence
over patient specimen processing conditions and will result in samples
being labeled and processed as calibration samples. For more
information, refer to Subsection: Processing with the Orders View.
Specimen Identification Methods

The System supports the use of a bar-coded Specimen ID on the specimen tube to
provide positive specimen identification. Positive specimen identification ensures
that results reported for a specimen tube are associated with the patient from which
the specimen was drawn. In Closed mode, the bar code on the tube is read by a bar
code reader in the Analyzer at the point of aspiration. In Open Tube mode, the bar
code on the tube is read by the Hand-Held Bar Code Reader. In both cases, the
Specimen ID from the tube is contained in the results record and is displayed next
to the results in the Datalog.
WARNING: DO NOT use any Specimen ID for a hematology specimen
that contains any of the following characters: |, \, ^, and &. These
characters will create an error message.
NOTE: Ensure that CAPS Lock on the keyboard is OFF when using the
Hand-Held Barcode Reader.
In Closed mode, specimens can also be identified by rack and tube position
numbers. If bar code labels are not used on specimen tubes, specimen identification
is by rack and tube position numbers only, offering a physical location for the tube,
which must subsequently be positively identified and verified by the laboratory
before reporting specimen results.
In addition to positively identifying specimen results, using bar code labels on
specimen tubes ensures that the processing requested for the specimen via
Specimen ID-based Orders is actually performed on the specimen. Pending Order
entries can also be based on the rack and tube position numbers, again offering a
physical location for the tube, which must subsequently be positively identified and
verified by the laboratory before reporting results. When running controls in
Closed mode, Abbott Q Label bar codes on control tubes use processing directions
from and direct results to specific Quality Control ID (QCID) files.
5-18
Specimen Analysis
Section 5
Specimen ID Requirements
The specimen identification number, or the text entered in the Specimen ID field, is
used to identify the specimens run on the Analyzer. It is validated and:
must contain at least three and not more than twenty characters.
must not contain blanks.
must not contain LIS message delimiters, which will cause the Specimen ID
to be truncated at the point where the character is located within the ID.
must not contain the text Invalid_ID or No_ID.
CAUTION: In the event that the specimen is aspirated in the Open Tube
Mode and the Specimen ID is not entered in the Next Open Tube Entry
region, the record in the Datalog view displays as No_ID and is not
transmitted to the laboratory information system until it is edited using F4
Edit. If the record is printed, the Specimen ID field prints as No_ID until
it is edited in the Edit Demographic Information dialog box.
5-19
Section 5
Specimen Analysis
Introduction to the Orders View

The Orders view is operationally involved in Sample Processing in both the Open
and Closed Tube Modes. Processing and Specimen Demographic orders are
manually added to the CELL-DYN Ruby as Pending Orders, or automatically
added via the Laboratory Information System (LIS). The System matches either the
bar code label specimen ID, with entries contained in the Orders view, for
processing instructions. The system will not download orders when the system has
Rack and Tube matching ON.
The Orders button is selected from the tool bar to display the Pending Orders. The
Orders view displays the Pending Orders in a log format as a tabular list. Scroll bars
are provided to allow the display of additional records. The Orders view can store
up to 3,000 entries and will alert the operator when an attempt is made to save
additional entries into a full Orders view. The CELL-DYN Ruby software is
configured to automatically remove a Pending Order entry that was never used for
specimen processing from the Orders view approximately twelve (12) to forty
eight (48) hours after it was created and saved, or downloaded from the Laboratory
Information System (LIS).
F1 - Print function key can be used to print the summary report of Pending Orders.
WARNING: It is recommended that your laboratory set up a laboratory
procedure to require any unprocessed Pending Orders be viewed and
cleared at the end of each shift or day. Use of this procedure will maintain
an up-to-date Orders view and reduce the opportunity for any unprocessed
Specimen IDs, left in the Orders view for an extended time, to be matched
with a different patient with the same Specimen ID.
Orders view customization consists of:
Setting up the Default Patient Test Selection
Setting up a default match criteria (matching by bar code ID or rack and tube
position) when Pending Orders are manually created.
NOTE: The software only allows the operator to elect to change the default
match criteria that appears in the Create New Order Entry dialog
box when the Pending Orders view is empty.
For information on Orders Setup, refer to Section 2: Installation Procedures and
Special Requirements, Subsection: Patient Sample Setup... and Orders Setup.
5-20
Specimen Analysis
Section 5
Default Patient Test Selection Processing Conditions

The CELL-DYN Ruby System is set up to automatically process and analyze
specimens in the Closed mode according to a Default Patient Test Selection if there
is no Pending Order and the bar code ID is not a QCID. The laboratory can
customize a Default Patient Test Selection to perform either one of the following
test selections CBC, CBC+NOC, CBC+RRBC, when the following occurs:
The System is matching by bar code ID and detects a readable bar code label
for the specimen ID for the tube being processed in the Closed mode, and no
matching order is found, the default test selection is performed and the
Specimen ID in the Datalog will be the tube bar code ID.
The System is matching by bar code ID and is unable to detect a readable bar
code label for the specimen ID for the tube being processed in the Closed
mode, the default test selection is performed and the Specimen ID in the
Datalog will be documented as Invalid_ID or No_ID based on tube bar code
validation.
The System is matching by rack and tube and detects a readable bar code
label for the specimen ID which is not a QCID label for the tube being
processed in the Closed mode, the default test selection is performed and the
Specimen ID in the Datalog will be documented as Rxx Tyy position based
on tube bar code validation.
The System is matching by rack and tube and is unable to find a matching
order for the rack and tube being processed in the Closed Mode, the
Specimen ID in the Datalog will be documented as Rxx Tyy position based
on tube bar code validation.
Table 5.9
Processing With Default Patient Test Selection

Task
Steps
Result/Comment
Identify specimens
Label tubes with bar code labels.
Refer to Section 4: Performance

Characteristics and Specifications,
Subsection: Bar Code Specifications.
Check or change
Default Patient Test
Selection
Check Patient Sample Setup

Demographics dialog box
Refer to Section 2: Installation

Procedures and Special
Requirements, Subsection: Patient
Sample Setup... Default Patient Test
Selection
Load tubes
Place tubes in racks.
Loading order is important if using Rack

and Tube matching.
Analyze specimens
Select F11- Select Closed, F12 Start

Loader.
Begins specimen processing.
5-21
Section 5
Specimen Analysis
Pending Orders (Match Specimen ID or Match Rxx Tyy)

Processing and Specimen Demographics are added to the CELL-DYN Ruby as
Pending Orders manually, or automatically, via the Laboratory Information System
(LIS).
Pending Orders originating from the LIS are created to match the bar code label
specimen ID with the pending order specimen ID as the match field. These entries
contain a non-blank Specimen ID value, do not contain a rack and tube position
value, and cannot be QCIDs.
Manually entered Pending Orders must match the Orders Setup and either match:
the bar code label specimen ID with the pending order specimen ID
the rack and tube (Rxx Tyy) position with the Rack ID and Tube ID fields in
the New Order Entry dialog box
If the match field is match by bar code label specimen ID, the operator must verify
or enter the Specimen ID field in the New Order Entry dialog box and is not
allowed to enter a Rack ID or Tube ID value in the New Order Entry dialog box.
If the match field is match by rack and tube (Rxx Tyy) position, the operator must
enter a Rack ID and Tube ID value and also enter a Specimen ID in the New Order
Entry dialog box. These entries contain a non-blank specimen ID value and cannot
be a Quality Control ID (QCID).
See also Section 2: Installation Procedures and Special Requirements,
Subsection: Orders Setup, to customize by rack and tube matching.
Pending Order Entries from the LIS

The CELL-DYN Ruby allows Pending Orders to be downloaded from an
interfaced Laboratory Information System (LIS). A special program must be
written using the CELL-DYN Ruby LIS Interface Specification as a guide. This
document is an optional information accessory with the System. For ordering
information, refer to Appendix A: Parts and Accessories.
NOTE: The information from the LIS must contain specimen ID numbers
corresponding to the bar code labels on the tubes. The System will not
accept Pending Orders from an LIS to match by rack and tube position.
Processing with the Orders View

The Orders view is used to display the Pending Orders log and also to access F6 Create Order that opens the New Order Entry dialog box. To display Pending
Orders, select Orders from the tool bar.
Manual Pending Order entries for control and calibrator specimens are not
required. When control specimens with QCID bar code labels, or Q-labels, are run
in the Closed mode and match a QCID setup, the System recognizes the QCID and
processes the specimen according to the QCID setup, which takes precedence over
processing using Pending Orders. When calibrator specimens are run using
software wizards such as the Auto-Calibration Wizard or Quick Precision Check,
the specimens are processed according to the wizard taking precedence over
processing using the Pending Orders.
5-22
Specimen Analysis
Section 5
Pending Orders in Closed Mode

In the Closed mode, the System attempts to match the specimen ID or the rack and
tube (Rxx Tyy) position with a Pending Order Entry for processing instructions.
The CELL-DYN Ruby software is shipped with default settings to match, based on
the specimen ID. When a match is found, the System uses the processing
instructions defined from the Pending Order entry. Once a specimen with a
matched Pending Order entry is processed, the entry is automatically deleted from
the Orders view and results are placed in the Datalog. Specimen tubes with
readable bar code labels will cause the System to search the Pending Orders for an
entry with a match field of match Specimen ID. Specimen tubes without a bar code
label will cause the System to use the default patient test selection and the specimen
ID in the Datalog will indicate No_ID.
If Orders Setup is set to use rack and tube matching, Specimen tubes with or
without a bar code label causes the System to search Pending Orders for an entry
using a match field of match Rxx Tyy. Specimen tubes with a bar code label will
have an additional validation against the specimen ID in the pending order. If the
rack and tube position matches the order, but the tube bar code read does not match
the Specimen ID in the order, the specimen is processed using the Default Patient
Test Selection, and the rack and tube position will be used in the Specimen ID field
in the Datalog; however, a system message will be generated indicating there was
a specimen ID mismatch.
5-23
Section 5
Specimen Analysis
Pending Orders in Open Mode

In the Next Open Tube Entry (NOTE) region, as the operator enters the specimen
ID in the Specimen ID field, the System attempts to match the Specimen ID with a
Pending Orders Entry for processing and specimen demographics. Once a
specimen with a matched Pending Order entry is processed, the entry is
automatically deleted from the Orders view and results are placed in the Datalog.
Because the Open mode does not use rack and tube position processing, there is no
search of the Pending Orders if the Orders Setup is set to match by rack and tube
there will be no matches found when entering the specimen ID in the NOTE region.
NOTE: The Reticulocyte test selection can only be run in the Open Mode. A
system message will alert the operator when it has identified a specimen
ID match within the Pending Orders but the test selection for the
Specimen ID in the Pending Orders does not match the current test
selection in the NOTE region. For example, the test selection is CBC but
the pending order is for a Retic test selection. The Pending Order
specimen demographics will also be used to fill in the NOTE detailed
dialog box. See also Section 12: Reticulocyte Package.
Host Query
If no match for a Specimen ID is found in the current Orders list, the Host Query
function allows an operator to query the host computer for an order for that
Specimen ID.
Closed Mode
After the tube barcode is read, the Orders list is searched for a match. If no match
is found, and Host Query is enabled, the Ruby will automatically query the host
computer for an order for that Specimen ID. If a new order is found, the processing
instructions in the order will be used for the specimen. If no new order is found with
Host Query, the specimen is processed using the default Patient Test Selection.
Open Mode
When a tube barcode is scanned or entered in the NOTE region, the Orders list is
searched for a match. If no match is found and Host Query is enabled, the Host
Query Button will be active in the NOTE region. Selecting the button will query
the host computer for an order for that Specimen ID. If a new order is found, the
processing instructions in the order will be used for the specimen. If no new order
is found with Host Query, the specimen is processed using the default Patient Test
Selection.
NOTE: If a match for the Specimen ID is found in the Order list, the Matched
indicator replaces the Host Query button.
5-24
Specimen Analysis
Section 5
For information on enabling Host Query, refer to Section 2: Installation

Procedures and Special Requirements, Subsection: System Customization, LIS
Setup.
Create Manual Orders

The Pending Orders log will not accept a mixture of processing orders to match by
both specimen ID and match by rack and tube. Matching by rack and tube
(Rxx Tyy) is customized in the Orders Setup dialog box and can only be enabled/
disabled if the Pending Orders log is empty. Rack and tube orders are only created
manually.
NOTE: If matching by rack and tube is selected, RETIC is not available as a test
selection for New Order Entry since Retic can only be run in the Open
Mode.
New Order Entry Dialog Box
The Orders View and F6 - Create Order button are used to create Pending Order
entries.
5-25
Section 5
Specimen Analysis
General Concepts for New Order Entry Creation

Select the Orders view from the tool bar.
Use F6 - Create Order to open the New Order Entry dialog box.
Enter the demographic information.
Select OK to save the entry.
Select the F6 - Create Order to continue making entries.
Once the entry is created and saved, it is displayed in log format in the
Orders view.
General Concepts for Reorder Entries from the Datalog and Group
Views
The System allows the operator to create orders for patient records from the
Datalog or Group views.
Datalog View
Select the Datalog view from the tool bar.

Highlight the Datalog record and select F7 View Specimen.
The F6 - Create Order function key is only available for patient specimen
types.
Select F6 - Create Order to open the Reorder Entry dialog box. The Test
Selection field will default to display the Datalog record test selection.
NOTE: Matching by rack and tube is available if it is customized in the
Orders Setup dialog box.
Verify specimen demographic information.
Select OK to save the entry.
Once the entry is created and saved, it is displayed in log format in the
Orders view.
5-26
Specimen Analysis
Section 5
Groups View
Select the Groups view from the tool bar.

Select the FWBC or NRBC/RRBC or exceptions tab view.
Use the mouse do one of the following:
Mouse click to highlight a record
Ctrl key + mouse to point and click to select various records to create
reorders
Shift key + mouse to point and click to select a range of records to create
reorders
Select F6 - Create Order to open the Reorder Entry dialog box. The Test
Selection field will default to display the recommended reorder test selection
based on the Group tab view.
Once a sample is ordered or deleted from either FWBC, NRBC/RRBC or
Exceptions, it is removed from all three groups.
FWBC: recommended reorder test selection is CBC+NOC
NRBC/RRBC: recommended reorder test selection is CBC+RRBC
NOTE: The F6 Create Order function key is not available in the Groups
view if matching by rack and tube is enabled in the Orders Setup
dialog box.
For one reorder at a time, select OK to save the entry.
For a selection or range of reorders at one time, select the Yes button to
proceed with creating reorders for the selected specimens with the
recommended reorder test selection.
NOTE: Duplicate specimen orders are not accepted into the Orders view.
Printing a Pending Orders Log

To print a report of all the records in the Pending Orders log, select the Orders view
and select F1 Print. The report shows the number of records in the Orders view
and includes the displayed column header information for: Record number (Rec#),
Specimen ID (Spec ID), Rack and Tube position (RRTT), Test Selection, Patient
ID (Pat ID), Patient Name (Pat Name), Sex, DOB, Doctor, Parameter Set (Param),
Limit Set (Limits), Entry Date and Time (Entry D/T), and Draw Date and Time
(Draw D/T).
NOTE: The following displayed column header information: User Field 1, User
Field 2, and Comment demographic fields do not print on the Pending
Orders report.
5-27
Section 5
Specimen Analysis
Orders Management
Entries in the current Orders view can be edited or deleted before the specimens are
processed. The CELL-DYN Ruby software can be customized to automatically
remove a Pending Order that was never used for specimen processing from the
Orders view approximately twelve (12) to forty eight (48) hours after it was created
and saved or downloaded from the Laboratory Information System (LIS). Use the
following procedures. See Section 2: Installation Procedures and Special
Requirements, Subsection: Orders Setup to customize automatic selection.
WARNING: It is recommended that your laboratory set up a laboratory
procedure to require any unprocessed Pending Orders be viewed and
cleared at the end of each shift or day. Use of this procedure will maintain
an up-to-date Orders view and reduce the opportunity for any unprocessed
Specimen IDs, left in the Pending Orders for an extended time, to be
matched with a different patient with the same Specimen ID.
Table 5.10
Procedure to Edit Pending Orders
Task
Step
Comment
Open Orders View
Select Orders from the tool bar.
Displays Pending Orders tab view.
Specify record to edit
1. Scroll through Pending Orders to

bring entry into view.
2. Highlight entry from Pending Orders
Log.
Highlights record to be edited.
Open Edit Order

Entry dialog box
Select F4 - Edit.
Displays Edit Order Entry dialog box in a

form for editing.
Change processing
information
Use buttons and resulting menus to

change processing selection.
Changes processing selection.
Change
demographics
1. Select field.
2. Type new information.
3. Repeat step 1-2 for additional fields.
Edits processing or demographic

information.
NOTE: The Hand-Held Bar Code
Reader is an optional means of
entering the specimen ID.
NOTE: Future Draw Date or future Date
of Birth (DOB) will automatically
default to the current date.
Save edited
information
Select OK button.
Saves the edited Pending Order.
View and edit

additional records
Repeat procedure, starting from Task:

Specify record to edit, above.
Selects additional Pending Order for

editing.
5-28
Specimen Analysis
Section 5
Table 5.11
Procedure to Delete Pending Order Entries
Task
Steps
Result/Comment
Open Orders View
Select Orders from the tool bar.
Displays Pending Orders tab view.
Delete Selection
1. Highlight the selection or selections.

2. Using the mouse, keep the cursor
over one of the highlighted
selections, right click and the drop
down menu opens.
3. Select Delete Selection from the
menu item.
4. Select Yes button in the Message
dialog box to confirm deletion.
Deletes the highlighted entry.
Delete All
1. Using the mouse, right click

anywhere in the view, and the drop
down menu opens.
2. Select Delete All from the menu
items.
3. Select Yes button in Message dialog
box to confirm deletion.
Deletes all entries in the Pending Orders

log.
5-29
Section 5
Specimen Analysis
Open Mode Analysis

Table 5.12
Open Mode Analysis

Task
Step
Result/Comment
Preparation
Verify the Analyzer Status indicates

the Ready state and is in the Open
mode.
Select F11 Select Open to

switch from Closed mode.
Enter Specimen ID in the Next

Open Tube Entry (NOTE)
region
1. Wand or enter the specimen ID in

the Specimen ID or QCID field.
2. Select the test selection from the
drop down menu.
3. Select More Spec Info button to
verify, add, or change specimen
demographic information in the
Next Open Tube Entry (Detailed)
dialog box.
If the specimen is a quality

control specimen the specimen
type and test selection will be
automatically selected based
on the QCID setup.
If the specimen has a
Mix Specimen Tube
With the stopper still in the tube,

gently mix the sample.
Gently rock or invert the tube a

minimum of 5 times to thoroughly
mix the sample.
Aspirate Specimen
1. Open the sample tube and place it

under the Open Mode Probe.
Raise the tube until the end of the
probe is deeply immersed in the
sample.
2. Press the Touch Plate to activate
aspiration.
3. Remove the tube when the beep
sounds and replace the cap.
NOTE: Do not let the probe touch

the bottom of the tube. It
may affect aspiration and
produce erroneous
results.
The wash block moves down the
probe and cleans it. When the
cycle is finished the wash block
moves back up the probe.
Review Results
When the cycle is finished, the results

post to the Datalog and are displayed
in the Run View.
Analyzer Status indicates Ready

state.
5-30
matching pending order, the

test selection will be
automatically selected
based on the order.
Specimen Analysis
Section 5
Closed Mode Analysis

:
Table 5.13
Closed Mode Analysis

Task
Step
Result/Comment
Preparation
Verify the Analyzer Status indicates

Ready state and is in the Closed
mode.
Select F11 Select Closed to switch

from Open mode.
Mix Specimens and Load

Racks
Mix the specimens and place them

in the Sample Loader racks.
Refer to Subsection: Specimen

Mixing.
Place Racks in the Loader
Place the racks in the Sample

Loader to the right of the Processor
Cover with the rack bar code labels
facing the Operator.
The Sample Loader does not operate

if the Processor Cover is not in place.
Start Loader
Select F12 Start Loader.
The Sample Loader automatically

processes all the specimens
according to QCID setup, Pending
Orders, or Default Patient Test
Selection.
Processing stops when either of the
following occurs:
The F12 Stop Loader function
key is selected
The last rack has moved
completely to the unload side of the
Sample Loader.
Review Results
The results are posted to the

Datalog and are displayed in the
Run View.
The Run View refreshes as each new

sample result is available.
5-31
Section 5
Specimen Analysis
NOTES
5-32
Section 5
Post-Analysis Processing Datalog View

After the System processes specimens, the CELL-DYN Ruby software
automatically stores the run result data (along with any entered ID and
demographics) in the Datalog for review and validation. This section describes the
Datalog and how to search and find, view, transmit, and print results.
Alerts and Indicators
Run View
Datalog View
Refer to Subsection: Advanced Data Management Groups View for flagging
indications and the Groups View.
Alerts and Indicators

This subsection describes information displayed on the screen as the samples are
analyzed and/or when reports are printed. This subsection does not discuss how to
interpret parameter flags, which are displayed after the sample is run. Refer to
Section 3: Principles of Operation, Subsection: Operational Messages and Data
Flagging.
Out of Range
Results that fall outside the range of the selected limit set are displayed in color.
Yellow indicates that the result exceeded the lower limit and purple indicates
that the result exceeded the upper limit. These results are underlined on the
graphic printouts.
Results that exceed a parameters linear range are indicated by >>>> in place
of the result.
Results that have been determined to require laboratory validation are
indicated by an asterisk [*] next to the result.
Results that do not have sufficient data to calculate values are represented
by -------.
System Messages and Fault Conditions

System Information Message dialog boxes appear in the view when a fault
condition is detected that requires Operator intervention. See Section 10:
Troubleshooting and Diagnostics, Subsection: System Messages for details on
System Messages and System Information Messages.
Flow Errors
If an RBC Flow Error occurs, results are suppressed for the RBC/PLT parameters
and the RBC flow error message is displayed in the System Message region.
Scatterplots are not suppressed. They are not analyzed.
5-33
Section 5
If a WOC Flow Error occurs, results are suppressed for the WBC and Differential
and the WOC flow error message is displayed in the System Message region.
Scatterplots are not suppressed. The list mode data is not analyzed.
If a NOC Flow Error occurs, results are suppressed for the WBC and Differential
and the NOC flow error message is displayed in the System Message region. The
Loader will halt for three consecutive Flow errors at the end of the cycle in process.
Sampling Errors
The message Sampling error incomplete aspiration is displayed in the System
Message region if insufficient sample was detected during aspiration. SAMPLING
ERR is printed on the graphics report to the right of the PLT.
3 Consecutive Short Samples
If the Sample Loader is being used and the Instrument detects three consecutive
incomplete aspirations, the Sample Loader halts at the end of the cycle in process
and 3 Consecutive Short Samples is displayed in the System Message region.
Heater Errors
If a WOC Heater Error occurs, results invalidated for the WBC and Differential
parameters are marked with an asterisk (*). The WOC heater error message is
displayed in the System Message region.
If a HGB Heater Error occurs, results invalidated for the HGB, MCH, and MCHC
parameters are marked with an asterisk (*). The HGB heater error message is
displayed in the System Message region. The Loader will halt for three consecutive
Heater Errors at the end of the cycle in process.
NOTE: WBC and WOC are asterisked for all cases except for runs with a
Specimen Type of Patient and the CBC + NOC Test Selection, where the
WBC value always comes from the NOC.
Run View
For customization of the Run view see Section 2: Installation Procedures and
Special Requirements, Subsection: Customize Run View.
5-34
Section 5
Chartable Page
Lab Page
5-35
Section 5
Graphs Page
Datalog View
5-36
Section 5
The Datalog stores all data and demographic information in a log format for the last
10,000 cycles run on the CELL-DYN Ruby. The record information is stored
chronologically by sequence number. Scattergrams and histograms are stored for
all 10,000 records.
NOTE: When the log is full, subsequent entries cause the oldest entry to be
deleted and the remaining entries to move up one line, so that the current
records are added to the bottom of the list.
NOTE: After a QCID has been deleted (either QC Whole Blood or QC
Commercial) the data log will show:
Specimen ID: Deleted_QCID

Original Specimen ID: <blank>
Draw Date: <blank>
Draw Time: <blank>
Lot Number: <blank>
Expiration Date: <blank>
Parameter set: 1
Data in fields other than those noted are unaffected by the QCID deletion.
See Section 2: Installation Procedures and Special Requirements, Subsection:
Customize Data View and Customize Printed Report for details on
customizing the display and printouts of the datalog.
Figure 5.2
Datalog Function Keys
Table 5.14
Datalog Specimen Type Icons

Specimen Type
Icons
Patient
QC-Commercial
QC-Wholeblood
QC-Background
Auto-Background
SRP-LATEX
AutoCalibration - Calibrator
AutoCalibration-WholeBlood
5-37
Section 5
Table 5.15
Datalog Function Keys
Function key ...
What it does ...
Comments
F1Print
Prints the selected record or a range

of records
Print Summary View or print Single

Specimen View report for each record in
selected range.
F2Transmit
F3Find/Filter
Transmit Data
Opens the Find/Filter dialog box
which has two tabs Find/Filter
and Advanced Find/Filter. Both are
used to locate a particular record by
entering information.
Find locates the earliest matching
entry, displays the number of
matches, and adds a Find Next key
to move to the next matching entry.
Filter closes the dialog box and
displays a new screen with all the
matching entries; exit the filtered
entries by selecting the Unfilter
function key.
NOTE: When searching for a name
that contains an apostrophe
(), enter two apostrophes in
the Namefield to return
search results.
NOTE: Before searching by
Specimen Sub Type in
Advanced Find/Filter,
Specimen Type must be
selected first. QC is the only
Specimen Type that has a
Specimen Sub Type.
Opens the Edit Demographic
Information dialog box
Any change made to the Specimen ID,

and saved by selecting OK and closing
the Edit Demographic Information
dialog box changes the format of the
listing from black to red.
F4Edit
A red sequence number indicates a
flagged item.
NOTE: If changes do not match
existing patient limits, a
checkbox displays asking the
operator to verify the request.
5-38
Section 5
Table 5.15
Datalog Function Keys (Continued)
Function key ...
What it does ...
Comments
Opens the Reorder Entry dialog box
Completing the Reorder Entry

information and selecting OK sends the
Reorder Entry information to the
Pending Orders queue in Orders.
F6Create Order
NOTE: Becomes
available after F7View
Specimen in the Datalog
view is selected.
F7View Specimen
Opens the Chartable, Lab, and

Graphs tabs, and:
Expands the existing Datalog
function keys:
F1Print
F2Transmit
F3Find/Filter
F4Edit
By adding three function keys:
F6Create Order
F7Previous Specimen
F8Next Specimen
F7Previous
Specimen
NOTE: Becomes
view is selected.
Changes the current view to reflect

the data in the previous entry in the
Datalog list.
Appears as a function key when F7

View Specimen in the Datalog view
has been selected.
F8Next Specimen
NOTE: Becomes
view is selected.
Changes the current view to reflect

the data in the next entry in the
Datalog list.
Appears as a function key when F7

View Specimen in the Datalog view
has been selected.
5-39
Section 5
Backing up and Restoring System Data

A user may wish to back up the system data on a regular basis in order to be able
to restore if there is a hard disk failure. It is not necessary to restore on a regular
basis. Once the Datalog is full (10,000 runs) the backup process will take up to 30
minutes and will require two 700MB CDs. The restore process will take about 12
minutes for the full datalog case. Only an operator with Admin rights can perform
backup and restore procedures.
The System provides the following backup features:
Automatically backs up data once every 24 hours. Automatic backup allows
the Operator access to data in the event of an unexpected shutdown.
Displays a message if there is a problem during the backup
Allows the Operator to configure the daily backup start time (the default is
midnight)
Displays a message that the Operator cannot exit the System during the
automatic backup
Automatically performs a full backup if the Operator restores the System
from a CD or diskette
NOTE: The restore process will shut down the Analyzer as well as the Data
Station.
NOTE: Software backup to CD cannot be performed during the time when auto
backup of database is in process.
PROCEDURE: BACKUP OF SYSTEM DATA
NOTE: A user with admin rights must be logged on to perform this procedure.
1. Verify the Analyzer is in the Ready state.
2. From the menu bar, select File, Backup . The Backup dialog box opens.
5-40
Section 5
3.
4.
5.
6.
7.
In the Backup to CD field, select both checkboxes.

Insert a CD in the CD/DVD ROM drive.
Wait until the green light on the CD/DVD ROM drive no longer flashes.
In the Backup to CD field, select the Start Backup button.
The dialog box will flash messages telling you of the progress. A progress bar
will fill up the indented rectangle.
8. Once the first CD is written, a message will appear:
Label the disk Disk 1. Please insert a Blank CD media in the CD drive and
press OK.
Remove the first CD (Disk 1), insert a second CD and select OK.
9. Once the second CD is written to, the dialog will close and the CD/DVD
ROM Drive will eject the CD. Label the second CD Disk 2.
PROCEDURE: RESTORING SYSTEM DATA
2. Put Disk 1 in the CD/DVD ROM drive.
5-41
Section 5
3. From the menu bar, select File, Restore. The Restore dialog box opens.
The flashing red text will identify the source of the install disk.
4. In the Restore from CD field, select all the setups you want to restore. If the
selected setups did not exist in the backup, you will be notified by a message
box identifying the setup. Select OK if this is expected.
5. In the Restore from CD field, select the Start Restore button.
6. After the first disk is uncompressed, the system will ask you for a second
disk. Put Disk 2 in the CD/DVD ROM drive and continue.
7. After all files are uncompressed a message box appears:
The application will now be restarted, allowing the restore process to
complete. This may take several minutes. Please ensure that the CD or floppy
diskette has been removed, and then select OK.
5-42
Section 5
8. Select OK. The application will close and the Disk will eject. The system will
reboot and restart. While restarting you will see the message: Please WaitRestore in progress.
NOTE: For the procedure to backup calibration factors following calibration,
refer to Section 6: Calibration Procedures, Subsection: PostCalibration Procedures.
IMPORTANT: The RESTORE procedure will restore the settings (e.g., patient
limit sets) that were in effect at the time of the last backup. If any
changes to settings were made subsequent to the last backup,
settings should be verified and adjusted if necessary.
Creating an Electronic Monthly Archive on the CELL-DYN Ruby

An electronic monthly archive may be created as an alternative to printing out the
Datalog monthly. The process for creating an electronic archive involves 3 steps:
1. Create a page in the Datalog View containing all the parameters you want to
save.
2. Select the media you wish to use for saving (floppy disk or USB memory
stick).
3. Use the Save Records function to save the monthly data.
PROCEDURE: CREATING A PAGE IN THE
PARAMETERS YOU WANT TO SAVE.
DATALOG VIEW CONTAINING ALL THE
1. Go to the Datalog View and put your cursor on any tab. Then right click and
select Customize Data View.
2. Select Add Page, and name the page Monthly Archive.
3. Add all the parameters that you want included in your archive, and select OK
when finished.
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Section 5
PROCEDURE: SELECTING THE MEDIA YOU WISH TO USE FOR SAVING (FLOPPY
DISK OR USB MEMORY STICK)
1. Insert an empty 3 inch floppy disk into the floppy drive.
2. If you dont have a floppy drive on the PC you are using to archive, you may
use a Windows compatible USB memory stick. Insert the USB memory stick
into the USB port (located at the back of the analyzer). Or you can use an
appropriate USB 2.0 Type A/B Extension Cable with a USB memory stick.
PROCEDURE: USING THE SAVE RECORDS FUNCTION TO SAVE THE MONTHLY
DATA.
1. In the Datalog View, select the Monthly Archive tab.
2. Highlight the sequence numbers of the records that you want to save.
3. Using the mouse, right click on the view. You will see the menu below:
4. Choose Save Records. The Save As dialog box displays.
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Section 5
5. From the Save in pull down menu select the A: drive if you are using a
floppy disk, or the appropriate drive for a USB memory stick.
6. Select the range of records you want to save, entering the numbers in the
Start SEQ# and End SEQ# fields.
7. Name the file whatever you desire.
8. Press Save.
9. When the save is complete, remove the floppy disk from the disk drive or the
USB memory stick.
NOTE: Save Records procedure as shown in steps 2-9 above may be
used to save records from other logs (for example: Event,
Maintenance and Reagents).
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Section 5
Viewing Archived Data

Once records are saved, you will have a csv file that can be viewed using Microsoft
Excel or Notepad on a Windows PC.
PROCEDURE: VIEWING THE CSV FILE
1. Insert the floppy disk into the floppy drive of a Windows PC (or insert USB
memory stick into the USB port).
2. Right click on the Windows Start button, and select Explore.
3. Click on the floppy drive or USB drive.
4. Select the Monthly Archive file or other log file.
5-46
Section 5
Advanced Data Management Groups View
The purpose of Groups view is to allow users to have filtered views of the Datalog
to support reflex test orders and transmission of records to the LIS.
Three groups of Datalog records found in the Groups view are formed based on the
following criteria:
FWBC Group: all records with specimen type Patient and CBC test selection
with the FWBC Suspect Population flag and the WBC Suspect Parameter
flag.
NRBC/RRBC Group: all records with specimen type Patient and CBC test
selection with the NRBC and/or RRBC Suspect Population flags and the
WBC Suspect Parameter flag.
Exceptions Group: all records with Specimen Type Patient that contain
alerted (Suspect Population, Suspect Parameter, Limit Violation or System
Flags) sample results.
Not Transmitted Group: all records that were selected for transmission to
the host computer, but were not transmitted.
NOTE: 1. If LIS transmission is set up to automatically transmit ALTERED
specimens, flagged specimens will not be added to the NRBC/RRBC,
FWBC, or Exceptions groups.
2. If Strict Specimen ID Validation is enabled in LIS setup, any
specimen without a valid Specimen ID will not be transmitted and will
appear in the Not Transmitted group.
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Section 5
Creating Orders From the Group View

When an order is requested for a single record in the FWBC Group, the test
selection that is initially displayed is CBC+NOC. If multiple records are selected
for order creation from the FWBC tab view, a message is generated to confirm that
the test selection to be used is as follows: -FWBC group: CBC + NOC.
When an order is requested for a single record in the NRBC/RRBC Group, the test
selection that is initially displayed is CBC+RRBC. If multiple records are selected
for order creation from the NRBC/RRBC tab view, a software message is generated
to confirm that the test selection to be used is as follows: -NRBC/RRBC group:
CBC + RRBC.
When an order is requested for a record in the Exceptions Group, the original test
selection is displayed.
NOTE: If the Orders Setup is configured to match on rack and tube position,
orders cannot be created from the FWBC, NRBC/RRBC, or Exceptions
Group.
Once an order from the Groups view is created from a record or group of records,
the record(s) for the sample(s) is removed from the Group view and is placed in the
Orders view.
Once a record in the Not Transmitted tab view is transmitted, the record for that
sample is removed from the group.
Deleting Records From the Group View
5-48
Section 5
Records can be manually deleted from the Groups view using the following
procedures.
To delete a record or several records:
1. Using the mouse, select the tab view and highlight the record(s) you want to
delete.
2. Using the mouse, right click in the Groups view and select Delete Selection
from the drop down menu.
3. Select the Yes button to confirm.
To delete all records:
1. Select F5 - Delete All
2. Select the Yes button to confirm.
5-49
Section 5
NOTES
5-50
Section 5
Advanced Data Management Rules Based Annotations

The Rules Based Annotation feature allows a user to specify text annotations that
will appear on the Single Record View and printout. Annotations display based on
evaluation of user-created rules, which use specimen result and/or demographic
criteria. The Rules Based Annotation feature is provided as an option to assist in
laboratory workflow.
IMPORTANT: Any invalid specimen result must be verified according to the
laboratorys protocol before being reported. Use of rules based
annotations does not eliminate the requirement for confirmation of
invalid results.
Up to 100 rules and 48 annotations may be created. Rules may be created by
a user with admin access level.
Individual rules can be enabled or disabled, and there is also the ability to
enable/disable the entire set of rules.
The software provides the ability for the user to verify that any single rule
performs as expected, and also that all enabled rules perform as expected.
NOTE: Each laboratory is responsible for validating rules before use.
The process for creating rules and annotations, and the other functions of the Rules
Based Annotation feature are discussed in the sections that follow.
Rule Setup Dialog Box
Rules related functions are managed from the Rule Setup dialog box (Figure 5.3).
Figure 5.3
Rule Setup Dialog Box
5-51
Section 5
Table 5.16
Fields Rule Setup Dialog Box

Fields
Rule
Rule Expression
Annotation
Table 5.17
Description
Lists the current Rules set and indicates enabled/disabled status
Displays the specific expression for the selected rule
Displays the annotation(s) associated with the selected rule
Buttons Rule Setup Dialog Box

Buttons
Create Rule
Edit Rule
Delete Rule
Delete All Rules
Description
Opens the Add New Rule dialog box
Opens the Edit Rule dialog box for the selected rule
Deletes the selected rule
Deletes all rules
Validate Selected Rule
Opens the Rule Validation dialog box, displays value fields for selected rule
Validate Enabled Rules
Opens the Rule Validation dialog box, displays value fields for all enabled
rules
Import
Allows transfer of rule setup from another analyzer on portable media
Export
Allows transfer of rule setup to another analyzer on portable media
Print
Annotation Setup
Close
5-52
Prints setup information for all rules

Opens the Annotation Setup dialog box
Exits the Rule Setup dialog box
Section 5
Creating Rules and Annotations

Creating Rules
Rules are created using numerical results, flags, demographics, or a combination
of these elements. Rules are logical expressions using operators (e.g., >, <, =) and
may be compound expressions with multiple elements connected by AND or
OR.
Selecting the Create Rule button in Rule Setup opens the Add New Rule dialog
box (Figure 5.4). The new rule is named, and then the rule is built by either typing
expressions, or dragging from the data elements list, operators list, and values list
into the rule expression box. A rule expression can contain a maximum of 256
characters.
Creating Annotations
Selecting the Annotation Setup button from either the Rule Setup or Add New
Rule dialog box (Figure 5.4) will open the Annotation Setup dialog box. The
maximum number of annotations is 48. Each annotation may contain a maximum
of 54 characters. Up to 15 annotations may be associated with a rule.
Figure 5.4
Add new Rule dialog box
5-53
Section 5
General concepts for rule creation

Expressions using alphanumeric text are case sensitive.
If the equals sign operator (=) is used for alphanumeric text, an exact
match is required, and the text in the rule must be in quotes (Example: Doctor
= John Doe).
The currently selected unit set is used for entered numeric values.
Expressions to check for the presence or absence of a flag use the =
operator and SET (flag is present) or NOT_SET (flag is absent) designations.
These designations are case sensitive.
A rule expression may contain an asterisk (*), but may not contain both a
numeric value for a parameter and an asterisk (*).
Example: (WBC = *) is a valid rule expression
(WBC >12.0) OR (WBC = *) is not a valid rule expression
To create a rule for the DFLT flag, all subparts (N, L, M, E, B) must be used
separately in a compound rule expression to create the desired combinations,
e.g., DFLT(NLMEB), DFLT(LM).
A rule for DFLT(LM) would be written as:
DFLT(L)_F=SET AND DFLT(M)_F=SET
During rule creation, the bulletin line at the bottom of the dialog box will display a
prompt for the next expected/required element in the rule expression, and error
information if a rule expression or value is entered incorrectly.
Table 5.18
Procedure: Creating Rules
Task
Open the
Rule Setup
dialog box
5-54
Steps
Result
1. Select Setup from the

menu bar, then select
Administrative Setup.
Section 5
Table 5.18
Procedure: Creating Rules (Continued)

2. Select Rule Setup. The
Rule Setup dialog box
opens.
Open the Add

New Rule
dialog box
3. Select the Create Rule

button.
The Add New Rule dialog box opens:
5-55
Table 5.18
Enter a Rule
Name
4. In Step 1 of the Add New

Rule dialog box, enter a
Rule Name in the Rule
Name field.
NOTE: The Rule Name may
contain a maximum of
40 characters.
Create the
Rule
expression
5. In the Data Elements field,

select a category and the
available data elements will
appear below it.
5-56
Section 5
Section 5
Table 5.18
Create the
Rule
expression,
cont.
6. Enter a data element into

the IF field by either typing
the data element or
dragging from the data
elements list.
7. Choose an operator and
data value from the lists on
the left side of the dialog
box. Type or drag the
selection into the IF field.
For numeric expressions,
type in the desired numeric
value.
NOTE: When a data element
is selected, the Data
Values and Operators
fields are
automatically
populated with the
options available for
the selected data
element.
5-57
Table 5.18
Section 5
Create the
Rule
expression,
cont.
Select the
Rule
Annotation
8. Continue building the rule

expression by entering
data elements, operators
and data values as desired.
Compound expressions may
be entered by using the
operators AND and OR. If
AND is used, both parts of the
rule expression must be true
for the entire rule to be
evaluated as true. If OR is
used, the rule is true if either of
the parts of the rule
expression is true. (This is
discussed further in the
section on Example Rules)
Note: Annotation creation is discussed in the next

procedure
9. Select the annotation(s) to

associate with the newly
created rule.
Move the annotation to the
THEN field using the left
facing arrow
. Annotations
can be removed from the
THEN field by using the right
facing arrow. Up to 15
annotations may be added to
a rule.
Validate the
New Rule
10. You may validate the new

rule now, or at a later time.
If you wish to validate the
rule now, select the
Validate Rule button.
NOTE: Rule validation is
discussed in a later
procedure.
Add the New

Rule
11. Select the OK button to

add the new rule.
5-58
The Add New Rule dialog box closes. The new rule is
displayed in the list in the Rule Setup dialog box.
Section 5
Procedure: Creating Annotations

Task
Steps
Result
Open the
Annotation
Setup dialog
box
1. From either the

Rule Setup or
Add New Rule
dialog box,
select the
Annotation
Setup button.
The Annotation Setup dialog box displays:
Open the Add

New
Annotation
dialog box
2. Select the Add

button.
The Add New Annotation dialog box displays:
Add new
annotation
3. Type in the
annotation and
click OK.
The new annotation is added to the annotation list and the Add New
Annotation dialog box closes.
Rules and annotations may be moved up and down in their respective lists by
dragging and dropping the rule or annotation in the desired location.
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Section 5
Enabling/Disabling Rules
Individual rules are enabled/disabled by checking or unchecking the box next to the
rule in the rule list.
Checking the Check this box to enable rules box at the top of the Rule Setup
dialog box enables the entire set of rules. This checkbox is unchecked during rule
creation.
NOTE: If the unit set is changed from the current configuration, the rules status is
automatically set to disabled. Rules containing numeric values may be
affected by a change to the unit set.
A message indicating that the change in units may impact rules is
displayed.
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Section 5
Example Rules
The following example rules are provided for illustration purposes only. The user
should develop and validate rules appropriate for their laboratory.
For each example, the Rule Expression is entered in the IF field in the Add New
Rule dialog box. The annotation is entered in the THEN field in the dialog box.
Example Rule 1: Single data element
The laboratory wishes to have the annotation Review Slide appear on records for
specimens with a WBC count greater than 15.0.
Rule Expression: WBC >15.0
Annotation: Review Slide
Example Rule 2: Compound rule expression
Dr. Jones requests that all PLT results less than 100 for his patients be phoned to
him.
Rule Expression: (PLT <100.0) AND (Doctor = Jones)
Annotation: Phone Results to doctor
Note the use of the operator AND in the rule expression. This will cause the
annotation to appear only for those samples with both PLT counts below 100,000
and Dr. Jones in the doctor demographic field.
If the operator OR was used, the annotation would appear on all records where
the PLT count was less than 100,000 (regardless of the doctors name), and would
also appear on all records for Dr. Jones patients (regardless of the PLT count).
Compound rules are evaluated from left to right.
Example Rule 3: Using a flag as a data element
The laboratory wants to review the scatterplot for every specimen with a BAND
flag.
Rule Expression: BAND_F=SET
Annotation: Review Scatterplot
Rules based on appearance of flags are created using the flag name, the equals
(=) operator, and SET for the presence of the flag and NOT_SET for the absence
of the flag.
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Section 5
Editing Rules and Annotations

Rules and annotations may be edited after they are created.
To edit a rule, open the Rule Setup dialog box, highlight the rule you wish to edit,
and select the Edit Rule button. The Edit Rule dialog box appears:
NOTE: Rules that have been edited should be re-validated to verify that the rule
evaluates as expected after the change.
To edit an annotation, select the Annotation Setup button from the Rule Setup,
Add New Rule, or Edit Rule dialog box. The Annotation Setup dialog box
opens:
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Section 5
Highlight the annotation to be edited, and select the Edit button. If the highlighted
annotation is currently assigned to a rule or rules, the following message appears:
Select Yes to continue editing the annotation, or No to cancel the edit and return to
the Annotation Setup dialog box.
Deleting Rules and Annotations
To delete a rule, open the Rule Setup dialog box, highlight the rule you wish to
delete, and select the Delete Rule button. A message will appear asking you to
confirm the deletion. Select Yes to delete the rule.
To delete all rules, select the Delete All Rules button. A message will appear
asking you to confirm the deletion. Select Yes to delete all rules.
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Section 5
To delete an annotation, open the Rule Setup dialog box and select the Annotation
Setup button. The Annotation Setup dialog box opens:
5-64
Section 5
Highlight the annotation to be deleted and select the Delete button. If the
annotation is used in one or more rules, a message will appear in the bulletin line:
The annotation must first be removed from any rule in which it is used before it can
be deleted. Use the Edit Rule function to remove the annotation, then return to
Annotation Setup. Highlight the annotation and select the Delete button. A
confirmation window appears:
Select Yes to delete the annotation.
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Section 5
To delete all annotations, select the Delete All button. If any of the annotations are
associated with current rules, the annotation(s) must be removed from the rules as
described above before they can be deleted.
Rule Validation (within software)

Rule validation is performed to verify that the rule(s) evaluate as expected.
The laboratory is responsible for validating rules before use. Each laboratory
should determine their own requirements for rule validation, including the need to
validate both true and false conditions.
The software offers the capability for rule validation within Rule Setup without
running patient samples. Rule validation may be done at the time of rule creation
or at a later time.
Rules may be validated individually, or all enabled rules may be validated at the
same time.
Validating a Single Rule
Open the Rule Setup dialog box and highlight the rule to be validated. Select the
Validate Selected Rule button. The Rule Validation dialog box opens:
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Section 5
PROCEDURE: TEST THE TRUE CONDITION

1. Enter a value for each rule expression element in the Value field in Step 1 of
the Validate Rule dialog box. The chosen value(s) should cause the rule to
be true.
For example: if the rule is WBC >15.0, enter any numeric value larger than
15.0, such as 17.3.
For compound rule expressions, enter values for each part of the rule
expression, again choosing values that will cause each part of the rule
expression to be true.
2. After all values are entered, select the Validate Rule button in Step 2 of the
Validate Rule dialog box.
The Rule Evaluation Results displays in the field below the Validate Rule
button.
3. Review the results. The Rule Evaluation Results displays the values entered
in Step 1, and displays the annotation returned. Check that the returned
annotation matches the annotation in the rule setup. Comments may be
entered in the Validation Comments field.
NOTE: The test may be re-run by repeating Steps 1 and 2.
PROCEDURE: TEST THE FALSE CONDITION
1. To test the false condition, repeat the steps above, but enter value(s) that do
not satisfy the rule.
For example: If the rule is WBC >15.0, enter some value less than 15.0, such
as 12.6.
NOTE: When testing the false condition for a compound rule that uses the
AND operator, choosing a value that does not satisfy one part of the
expression should result in a false condition for the entire rule.
2. The results for the false condition test should show that no annotation is
displayed.
3. When testing is complete, select the appropriate radio button (Passed or
Failed) in the Set Validation Status field.
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Section 5
PROCEDURE: PRINTING THE VALIDATION REPORT

1. To print the validation report for the rule, select the Print Report button. The
single rule report will contain the same information displayed in the Rule
Validation dialog box following rule validation.
2. When finished, select OK to close the Validate Rule dialog box.
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Section 5
Validate All Enabled Rules

1. To validate all enabled rules, select the Validate Enabled Rules button from
the Rule Setup dialog box. The Rule Validation dialog box displays:
2. The Rule Validation dialog box displays the rule expression elements for
each enabled rule. Enter appropriate values in the value field next to each
element, and select the Validate Rule button. Each rule is evaluated, and the
Rule Evaluation Results display.
3. Verify the evaluation results and repeat testing if needed.
NOTE: When validating all enabled rules, the Validation Comments and
Validation Status fields are active only when all rules have the same
status, i.e., all rules passed or all rules failed. If the status is not the same
for all rules, these fields are inactive.
4. Select the Print Report button to print the validation report. The validation
report for all enabled rules will contain the same information displayed in the
Rule Validation dialog box, plus all the information in the rules report.
(Refer to Printing the Rules Set later in this section).
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Section 5
Evaluating Rules During Run Time

Enabled rules are evaluated during sample runs after all required data is available
and acceptable for use.
The possible outcomes of rule evaluation are:
The rule is true; the annotation(s) are added
The rule is false; no annotation(s) are added
There is insufficient data to evaluate the rule; no annotation(s) are added
If the data required by the rule expression is not available or acceptable, the rule
will not be evaluated.
For example:
If a rule uses patient age as part of the expression and no date of birth is
provided, the rule will not be evaluated. Similarly, if a rule uses specimen age
and no draw date/time is specified, the rule will not be evaluated.
If a numerical result is used in a rule expression and the result from the
specimen run displays an asterisk (*) on the numerical result, the rule is not
evaluated. Example: if the rule is (WBC >15.0) and the actual specimen
result is 16.5*, the rule will not be evaluated.
Rules that reference a RETIC numerical result are not evaluated if the
specimen is run in a CBC type test selection, and vice versa.
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Section 5
Displaying Annotations
Annotations are displayed in the Run View and Single Specimen View on the
Laboratory Page, and appear as one line per annotation in the lower right region of
the display and printout. If an annotation appears for a specimen record, graphs 5
and 6 will not be shown.
Up to 15 annotations can appear on the display and printout. If rule evaluation
results in more than 15 annotations for a given record, only the first 15 annotations
will be displayed.
Figure 5.5
Single Record View
5-71
Figure 5.6
5-72
Section 5
Printed Specimen Report
Section 5
Order of annotation display

The order in which annotations are displayed following rule evaluation is based in
part on annotation sets. An annotation set is the group of annotations associated
with a rule.
For example:
If annotations 1 and 4 are associated with Rule 1, then the annotation set for
Rule 1 is A1, A4.
If annotation 3 is associated with Rule 2, then the annotation set for Rule 2 is
A3.
During the evaluation process, if more than one rule is found to be true and these
rules have the same annotation set, redundant annotation sets are removed.
Example:
Rule 1 annotation set = A1, A4
Rule 2 annotation set = A3
If all four rules are true, the displayed order of annotations will be:
A1, A4
A3
A3, A5
The annotation set for Rule 4 is removed because it is the same as Rule 1
(redundant). The annotation for Rule 2 is not removed because it is not the same
as Rule 3; the set A3 does not equal the set A3, A5.
After redundant annotations are removed, the remaining annotations are displayed
based on the order of rules in the rules list, except that a set containing the first entry
in the master annotation list (A1) is displayed first.
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Section 5
Printing the Rules Set

The set of rules may be printed from the Rule Setup dialog box by selecting the
Print button.
The printout contains the following information for each rule:
Rule Name
Rule expression
Annotation(s) associated with each rule
Enabled/disabled status
Last modified date/time
Validation status
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Section 5
Printing a Group of Specimens with Annotations

Steps to print all records in a specific time range that have Annotations.
1. Go to the Datalog View, press the F3 function key, Find/Filter, and select the
Advanced Find/Filter tab.
2. Enter the selection in the dialog below, using the Run Date/Time that limits
that you are interested in.
3. Select Filter. This will result in a filtered view of the datalog.

4. Right-click in the Datalog View to bring up the menu shown below.
NOTE: You can also open the Print dialog box by pressing the F1 function
key, Print.
5. Select Print
6. When the Print dialog appears, select All, Print as Single Specimen View
and Lab.
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Section 5
Importing /Exporting Rules

Rules setup may be transferred to another Ruby analyzer on diskette or USB flash
drive by using the Import/Export functions.
NOTE: Rules may not be transferred on CD-ROM.
PROCEDURE: EXPORTING RULES FROM PRIMARY ANALYZER
1. Insert the transfer media (diskette, USB flash drive) in the appropriate
location on the primary Ruby analyzer.
2. Open the Rules Setup dialog box, and select the Export button. The Insert
disk dialog appears. Click Cancel. A Browse for Folder window appears.
3. Select the target location (floppy drive, USB drive) and click OK. The
bulletin line displays a message when export has completed successfully.
4. When Export is complete, remove the transfer media.
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Section 5
PROCEDURE: IMPORTING RULES TO A SECOND RUBY ANALYZER

1. Insert the transfer media (diskette, USB drive) in the appropriate location on
the second Ruby analyzer.
2. Open the Rules Setup dialog box, and select the Import button. The Insert
disk dialog appears. Click Cancel. The Browse for Folder window appears.
3. Select the target location (floppy drive, USB drive) and click OK. The
bulletin line displays a message when import has completed successfully.
4. When Import is complete, remove the transfer media.
5-77
Section 5
NOTES
5-78
Section 6 Calibration Procedures
Section 6
Overview
Calibration is a procedure that confirms the accuracy of the CELL-DYN Ruby.
Calibration also assists in conforming to guidelines established by the regulatory
agencies that govern your laboratory.
The CELL-DYN Ruby is calibrated at the factory before shipment. During System
installation, an Abbott representative assists the operator in verifying factory
calibration.
The CELL-DYN Ruby is designed to remain stable, without frequent calibration,
when it is operated and maintained according to the recommendations in this
manual.
The following parameters reported by the CELL-DYN Ruby can be calibrated:
WOC, NOC, RBC, HGB, MCV, PLT, and MPV.
Calibration can be performed using either commercial calibrator or assayed whole
blood.
This discussion of calibration distinguishes between specimens and samples. They
are defined as:
Specimen
a tube of commercial calibrator material or assayed whole

blood that is presented to the Analyzer for sampling
Sample
the material that is aspirated from the specimen tube,

diluted, and analyzed
This section provides information about the following topics:

When to Calibrate
Calibration Guidelines
Pre-Calibration Procedures
Calibration Menu
Post-Calibration Procedures
6-1
Section 6
Overview
NOTES
6-2
Section 6
When to Calibrate
Scheduled calibration of the CELL-DYN Ruby must conform to the guidelines
established by regulatory accreditation agencies.
Confirm calibration on a regular basis according to your laboratorys standards and
protocols for maintaining good laboratory practice. Built-in Quality Control
programs on the CELL-DYN Ruby are designed to provide continual monitoring
and confirmation of instrument calibration. The laboratory should make the
decision to recalibrate based on the performance of the CELL-DYN Ruby System
in these Quality Control programs. For details on Quality Control programs, refer
to Section 11: Quality Control.
Calibration of the CELL-DYN Ruby may need to be verified in the following
instances:
When there is a complete change of reagents, i.e., change in type of reagent
from same vendor, or change to a different vendor.
When indicated by quality control data.
After major maintenance and service procedures.
At least every six months.
As directed by the regulatory agencies governing your laboratory.
One common method of calibration verification involves processing a commercial
calibrator and comparing instrument results to those published by the
manufacturer. When calibration verification criteria are exceeded, the instrument
must be recalibrated.
Always consider calibration as the last step in a troubleshooting sequence.
Frequent unnecessary calibration can mask an underlying problem with instrument
performance.
NOTE: If there are any questions about when to calibrate, contact your Country
Service and Support Center.
6-3
Section 6
When to Calibrate
NOTES
6-4
Section 6
General Information
The CELL-DYN Ruby System has two modes of operation:
Open
Closed
The System software applies the mode and parameter-specific calibration factor to
the data obtained when the specimens are run.
Two methods of calibration are available on the CELL-DYN Ruby System:
Auto-Calibration Wizard
Manual Calibration
The Auto-Calibration Wizard simplifies the generation of new calibration factors by:
Qualifying specimen results run in the primary mode of operation
Calculating the new calibration factors for activation by the operator
Copying these new calibration factors for activation from one mode to the other.
NOTE: The primary mode of operation (e.g., Open) should be calibrated
using the Auto-Calibration Wizard followed by an Open/Closed
Mode Bias Check using normal, fresh whole blood specimens.
Calibration Bias Wizard

The Calibration Bias Wizard allows users to quickly run calibration checks on
samples in Open/Closed modes. This process is useful when the user does not want
to run a full calibration, using the Auto-Calibration Wizard, which takes more time.
Users can ensure that results in open and closed modes meet manufacturer
specifications.
The Ruby Software provides automatic calibration of the open/closed mode bias,
using a guided step-by-step Calibration Bias Wizard. Tasks include:
Pre-calibration check
Bias check setup
Bias check results
Results for display or print
Manual Calibration
The Manual Calibration process is available for the operator to manually calculate
and enter new calibration factors.
6-5
Section 6
Calibration Materials
The CELL-DYN Ruby System requires commercial calibrator material or assayed
whole blood for calibration.
Calibrating with Commercial Calibrator

Commercial calibrator is a blood-based material with assayed reference values.
The values must be traceable to a national or international reference preparation or
method for hematology.
When using a calibrator, follow the instructions provided on the calibrator package
insert, for proper storage, handling, and mixing.
Abbott calibrator is for use in Open Mode only.
Abbott recommends cycling the calibrator a minimum of 6 and a maximum of 10
runs when using the Auto-Calibration Wizard.
For the Manual Calibration method, cycle the calibrator for a minimum of 6 runs.
Additional samples and/or repetitions of the specimens may be used to achieve
calibration accuracy beyond Clinical and Laboratory Standards Institute (CLSI)
recommendations.
For list numbers of calibrators refer to Appendix A: Parts and Accessories.
Calibrating with Assayed Whole Blood

Assayed whole blood is blood that has been analyzed and assigned values using a
reliably calibrated instrument or reference methodology.
Calibration using assayed whole blood is an alternative to calibration using
commercial calibrator. Whole blood specimens must meet certain requirements to
be suitable for use in calibration.
Abbott recommends cycling each of five whole blood specimens twice for a
total of at least 10 runs, when using the Auto-Calibration Wizard in either Open or
Closed Mode.
For the Manual Calibration method, cycle each of five whole blood specimens
twice for a total of at least ten runs. Use additional specimens and/or repetitions
of the specimens to achieve calibration accuracy beyond CLSI recommendations.
This subsection includes the following:
Recommendations and Requirements for Whole Blood Specimens
Recommendations for Reference Methodologies
Requirements for Obtaining Whole Blood Reference Values
CAUTION: Use commercial calibrator to calibrate the MPV parameter.
Do not use assayed whole blood.
6-6
Section 6
Recommendations and Requirements for Whole Blood Specimens

The following are recommendations and requirements for whole blood specimens
used in calibration.
The ICSH recommends that specimens used for calibration be less than four
hours old following venous sampling.1
The determination of reference values for whole blood and the analysis of
whole blood specimens of the CELL-DYN Ruby must be completed within
two hours of each other.
All specimen reference results must be within your laboratorys normal
range.
All cellular morphology must be normal. Specimens with interfering
substances or conditions must also be excluded. Refer to Section 7:
Operational Precautions and Limitations for a list of interfering substances
and conditions.
All specimens must be properly collected in tubes containing EDTA
anticoagulant. Follow tube manufacturers recommendations for fill volume
specifications.
Recommendations for Reference Methodologies

Reference methodologies used in assaying whole blood for calibration must
conform to the following ICSH recommendation for the parameters listed:
WBC, RBC, and PLT
HGB
MCV
WBC, RBC, and PLT
Determine reference values for white blood cells, red blood cells, and platelets
using:
Multiple counts from a certified hemocytometer, a counter that meters a
fixed, calibrated, sample volume.
Reliably calibrated hematology analyzer.
HGB
Determine reference values for hemoglobin using either:
The reference cyanmethemoglobin method.
A reliably calibrated hemoglobinometer or hematology analyzer.
Do not attempt to calibrate the CELL-DYN Ruby directly with a hemoglobin
standard designed for the calibration of specific reference cyanmethemoglobin
methods. The CELL-DYN Ruby uses a cyanide-free method that is not designed
to analyze these standards.
6-7
Section 6
MCV
Determine reference values for the mean cell volume by:
Calculation from reference microhematocrit and RBC measurements.
Multiple analyses on a reliably calibrated hematology analyzer.
Determine reference microhematocrit values by multiple analyses using the CLSI
method for Packed Cell Volume (PCV).2 Use only plain (non-anticoagulated)
capillary tubes for use with EDTA anticoagulated whole blood. Be certain to verify
the proper operation of the microhematocrit centrifuge and the timer as
recommended by CLSI.
Requirements for Obtaining Whole Blood Reference Values

The following table provides the numerical range of values that can be entered in
the Reference Value or Assay Value field in the Auto-Calibration Wizard
Setup. Reference values should be entered based on your laboratorys patient units
setup. Reference values outside these limits cannot be entered. You must use
Manual Calibration to calibrate any parameter with an assigned value that exceeds
the Auto-Calibration Wizard reference value or assay value entry range.
For more information on units setup, see Section 2: Installation Procedures and
Special Requirements, Subsection: Unit Sets Selection.
Table 6.1
Auto-Calibration Wizard Reference Value and Assay Value Entry Range
Parameter
Auto-Calibration Reference Value or Assay Value

Entry Range
SI
USA
WBC
> 1.99 < 25.0 x 109/L
> 1.99 < 25.0 x 103/L
RBC
> 2.00 < 6.50 x 1012/L
> 2.00 < 6.50 x 103/L
HGB
> 70.0 < 150.0 g/L
> 7.00 g/L <15.0 g/dL
MCV
> 70.0 < 130.0 fL
> 70.0 < 130.0 fL
PLT
> 50.0 < 600 x 109/L
> 50.0 < 600 x 103/L
MPV
> 4.99 < 15.0 fL
> 4.99 < 15.0 fL
CAUTION: Use commercial calibrator to calibrate the MPV parameter.

Do not use assayed whole blood.
6-8
Section 6
Obtaining Whole Blood Reference Values from a Reference Analyzer

Follow the procedures below to determine the reference values that will be used to
calibrate the instrument using whole blood.
1. Go to a reference hematology instrument (or use appropriate hematology
methods) with 5 specimens of normal, whole blood. Run each specimen at
least twice for a minimum of 10 replicates on the reference instrument.
NOTE: Because the same specimens will be used to first obtain reference
values on a reference instrument, then to calibrate the primary and
check bias on the secondary mode, it is important to begin with a
sufficient amount of each sample.
2. If a mean value for each parameter based on at least 10 runs is not
automatically calculated by the reference hematology instrument or
hematology methods, use a calculator to determine the cumulative Reference
Value Mean for each parameter.
For example:
The cumulative Reference WOC Mean is 7.15 when the WOC results from
each run are as follows:
Sample 1 = 9.2, 9.1
Sample 2 = 4.5, 4.6
Sample 3 = 6.1, 5.9
Sample 4 = 7.0, 7.3
Sample 5 = 8.9, 8.9
The cumulative mean of 7.15 equals the sum of the values (71.5) divided by
the 10 runs.
You may use the following worksheet to record the values obtained from
running samples on a reference instrument. Make copies of the blank
worksheet as necessary.
NOTE: Enter the WBC mean as the reference value for both the WOC and
NOC.
6-9
Section 6
Whole Blood Calibration Reference Values Worksheet

Date: _____________
Specimen ID
Operator:_____________
Run #
WBC
(WOC)
WBC
(NOC)
Reference Instrument: __________________
RBC
HGB
MCV
PLT
1
2
1
2
1
2
1
2
1
2
Sum of Values
Cumulative Mean
NOTE: The WBC value obtained on the Reference Instrument should be used for calibrating both the WOC
and NOC parameters on the CELL-DYN Ruby System.
6-10
Section 6
Overview
The Pre-Calibration Procedures in this subsection verify proper instrument
performance to ensure a successful calibration.
The Auto-Calibration Wizard prompts the operator to verify:
Pre-Calibration Maintenance Check Status
Pre-Calibration Reagent and Waste Check
Pre-Calibration Precision Check Status
NOTE: Verify that both the primary and secondary mode Quick Precision
Checks were completed and passed within 24 hours of beginning
the Auto-Calibration Wizard.
Pre-Calibration Background Check Status
For Manual Calibration, complete the steps in this section just prior to beginning
the calibration procedure. A pre-calibration checklist is available for the operator
to complete. See Subsection: Pre-Calibration Checklist.
If problems are detected during these checks, DO NOT ATTEMPT TO
CALIBRATE THE INSTRUMENT. If necessary, call your local Country Service
and Support Center for assistance. After the problems have been resolved, repeat
the Pre-Calibration Procedures to verify proper performance.
NOTE: Complete instrument calibration, including the pre-calibration
procedures, without interruption.
Pre-Calibration Guidelines
Perform the scheduled maintenance as directed in Section 9: Service and
Maintenance before calibrating the instrument. Instrument cleanliness is
essential for accurate calibration. Perform additional maintenance according
to laboratory requirements.
Use only recommended CELL-DYN reagents.
Verify the precision for the Open and Closed Modes using the Calibration,
Quick Precision Check menu bar item, prior to calibration as directed in
Subsection: Pre-Calibration Checklist.
Select and process all whole blood specimens according to the requirements
in Subsection: Recommendations and Requirements for Whole Blood
Specimens.
6-11
Section 6
The whole blood specimen volume should be at least 15 mL to accomplish

the following:
Obtain reference values on a reference instrument prior to calibration.
Run precision checks prior to calibration.
Calibrate the primary mode of operation.
NOTE: If one whole blood specimen is used in the Auto-Calibration
Wizard, it is important that a representative specimen be selected to
calibrate the instrument. A specimen containing abnormalities may
adversely affect calibration. If sufficient sample is not available,
use a different sample for precision check.
Be certain that all specimens used are brought to room temperature and
mixed well before aspiration.
Be certain that the operator performing the calibration has read and
understands the information contained in the package insert for the calibrator.
Be certain that the operator performing the calibration has read and
understands the calibration procedure(s) and the appropriate overviews
described in this manual.
Confirm that reagent containers are at least one third full. Replace them as
necessary. See Section 9: Service and Maintenance, Subsection: Reagent
Container Replacement.
Confirm that the waste container is no more than half full. If necessary,
empty it as described in Section 8: Hazards, Subsection: Waste Handling
and Disposal.
Confirm that background counts are within limits. A background count
should be run immediately prior to running any calibration specimens.
Confirm your Operator ID sign on.
Pre-Calibration Checklist
Follow the procedures outlined in the Pre-Calibration Procedures Checklist to
ensure the instrument is ready for calibration. Use the Calibration Notes to note any
problems encountered. Make copies of both lists as needed.
NOTE: For Manual Calibration, always complete the Pre-Calibration procedures
before beginning any calibration. For the Auto-Calibration Wizard, use
this checklist as a guide.
6-12
Section 6
CELL-DYN Ruby Pre-Calibration Procedures Checklist

Instrument Serial Number & Software Version: ____________
Date: _________________________
Operator: ______________________
1. _______ Perform all required maintenance.
2. _______ Verify that all reagent containers are at least 1/3 full and the waste container is less than 1/2 full.
3. _______ Verify that the reagents have not reached the expiration date.
Diluent/Sheath:
Lot #____________
Exp. date _______
HGB Lyse:
Lot #____________
Exp. date _______
WBC Lyse:
Lot #____________
Exp. date _______
4. _______ If applicable, verify that the calibrator has not reached the expiration date.
Lot #____________ Exp. date _______
5. _______ After the maintenance has been completed, verify that the background counts are within the
acceptable limits. Record the background counts below or attach a printout to this document.
WOC < 0.10 ________
NOC < 0.10
________
RBC < 0.02
________
HGB < 0.10
________
PLT < 5.0
________
6. _______ Verify the Analyzer Status is Ready State and in the Open Mode. Verify the Open Mode
precision as follows:
Obtain a normal whole blood specimen.
Select Calibration, Quick Precision Check from the menu bar, ensure the <Sampler
Mode> field indicates Open in the dialog box, and select New Precision Check button.
Enter the Specimen ID in the dialog box and run the specimen 10 times.
When the runs have been completed, select the Print button and write the %CV in the
appropriate spaces below and attach a file printout to this document.
PARAMETER
WOC
NOC
RBC
HGB
MCV
PLT
%CVLIMIT
< 2.4%
< 2.8%
< 1.8%
< 1.4%
< 0.8%
< 3.8%
%CV
________
________
________
________
________
________
7. _______ If the %CV for all parameters pass and fall within the limits, go to step 8 to verify Closed Mode
precision. If a parameters %CV exceeds the limit, select New Precision Check... button and
repeat step 6. If the over-limit condition persists, see Section 10: Troubleshooting and
Diagnostics, Subsection: Troubleshooting Imprecise or Inaccurate Data.
6-13
Section 6
8. _______ Verify the Analyzer Status is Ready State and in the Closed Mode. Verify the Closed Mode
precision as follows using the same specimen as in the Open Mode.
Aliquot the specimen into 10 5-mL empty specimen tubes containing no anticoagulant
(each tube requires a minimum volume of 1.5 mL of sample).
Select Calibration, Quick Precision Check from the menu bar, ensure the <Sampler
Mode> field indicates Closed in the dialog box, and select New Precision Check button.
Place the tubes in a rack, place the rack in the loading position, and select F12 - Start
Loader.
When the runs have been completed, select the Print button and write the %CV in the
appropriate spaces below and attach a file printout to this document.
PARAMETER
WOC
NOC
RBC
HGB
MCV
PLT
%CV LIMIT
< 2.4%
< 2.8%
< 1.8%
< 1.4%
< 0.8%
< 3.8%
%CV
________
________
________
________
________
________
9. _______ If the %CV for all parameters pass and fall within the limits, go to step 10. If a parameters %CV
exceeds the limit, select New Precision Check... button and repeat step 8. If the over-limit
condition persists, see Section 10: Troubleshooting and Diagnostics, Subsection:
Troubleshooting Imprecise or Inaccurate Data.
10. _______ If any problems are detected during the procedures outlined above, document them on the
following form. Make copies of this form as necessary.
11. _______ Continue with Subsection: Calibration Procedures.
6-14
Section 6
Calibration Notes
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
6-15
Section 6
NOTES
6-16
Section 6
Calibration Menu
Overview
This subsection gives an overview of Calibration menu items:
Access the Calibration menu from the pull-down Menu Bar by dragging down on
Calibration. The Calibration menu displays the selections.
Last Auto-Calibration Data

Select Calibration and Last Auto-Calibration Data... on the pull-down menu
and the Last Calibration: Sample Runs Summary dialog box opens, displaying
data from the last calibration. Select either Sample Mode, Open or Closed, to view
the data, which includes the run date, the run time, and the method.
This area is
blank if there
is no previous
data
6-17
Section 6
Calibration Menu
Table 6.2
Buttons Last Auto-Calibration Data...

Field
Close
Description
Closes the dialog box
Quick Precision Check

Verify the Analyzer is in the READY state.
Select Calibration and Quick Precision Check... on the pull-down menu and the
Quick Precision Check... dialog box opens in the mode displayed in the Analyzer
Status region, or, if there is historical data available, it is displayed indicating date,
time, and the sampler mode it was run in.
Sampler Mode: Open or Closed
Run results
Data analysis
of run results
6-18
Section 6
Table 6.3
Fields Quick Precision Check... Dialog Box

Field
A precision check was

performed on
Sampler Mode
Specimen ID
Table 6.4
Description
Date and time of last performed check.
Open or Closed
NOTE: This field is automatically filled with the
current Analyzer Status mode when
Calibration, Quick Precision Check... is
selected from the menu bar or historical
information based on last performed
precision check.
Enter the Specimen ID for the Specimen being run
Buttons Quick Precision Check... Dialog Box
Buttons
Print
New Precision Check
Done
Cancel
Description
Prints the Quick Precision Check... data
Clears the data to begin a new precision check
Saves the precision check data only if 10 samples
were run
Exits the wizard
NOTE: The Quick Precision Check will be cancelled by the software if any of the
following System Events occur:
Fault requiring initialization of software.
Reagent related operator correctable faults (except Waste Full).
Processor Tower Cover Open operator correctable fault (Open Mode).
Sample Loader related operator correctable faults.
NOTE: A run will not be accepted into the Quick Precision Check if it has a
Sampling Error fault.
6-19
Section 6
Calibration Menu
NOTE: Parameter status may display as FAILED in the Quick Precision Check
dialog box if any of the following occur:
The %CV for the parameter exceeds the %CV Ref
The run result for a parameter
is suppressed
displays as >>>>>
is flagged as invalid (marked with an asterisk)
Calibration Log
The Calibration Log is accessed either through the Calibration pull-down menu
on the menu bar or by selecting System from the tool bar.
The log displays up to 32 line entries in the view up to 3000 records. Once 3000
records have been reached, the oldest record is deleted each time a new record is
added. Additional log entries are accessed by using the arrows on the right-hand
side of the view.
Navigation
arrows
Horizontal scroll bar
6-20
Section 6
The Calibration Log has 17 columns. All columns may not be visible on the screen
at the same time. Use the horizontal scroll bar located at the bottom of the view to
access the unseen portion of the view. The Calibration Log displays the mode and
parameter-specific calibration factors for the CELL-DYN Ruby System
calibratable parameters. The Calibration Log also has the following columns:
Table 6.5
Fields Calibration Log View
Field
Rec#
Record number
DATE
Date the calibration occurred
Time
Time the calibration occurred
Mode: Open or Closed
Maint
Maintenance: Incomplete or Done
Prec
Precision Check: Incomplete, Fail or Pass
Bkgd
Background Count: Fail or Pass
OPID
ID of operator performing calibration
Method
Comment
Table 6.6
Description
Method of calibration factory, calibrator, whole blood, or

manual
Operator-entered comments at calibration
Buttons Calibration Log Dialog View
Buttons
Description
F1 Print
Displays the Print dialog box while in the Calibration

Log view, providing the following print options:
Record range:
All
Selection
Start Rec# End#
Number of copies
NOTE: Select File and Print Preview to verify
Landscape orientation is selected.
F3 Find/Filter
Opens the Advanced Find/Filter Dialog box. Used to

locate a particular record by entering information.
6-21
Section 6
Calibration Menu
The Auto-Calibration Wizard program provides a calibration wizard that prepares
the CELL-DYN Ruby System for calibration, calculates new calibration factors,
and copies those new calibration factors from one mode to the other.
The Auto-Calibration Wizard... is accessed from Calibration on the menu bar
and Auto-Calibration Wizard... on the pull-down menu.
When specimens are run, the Auto-Calibration Wizard:
Accepts up to ten specimen runs for calibrator.
For whole blood specimens the number of allowed specimens, runs per
specimen and total number of specimens allowed is as follows:
1) A minimum of 2 and a maximum of 5 different whole blood specimens
is required.
2) The number of runs per specimen must be a minimum of 2 and a
maximum of 5 so that the number of total runs is between 6 and 20.
Compares sample results against internal precision and reference checks,
highlighting results that fail.
Calculates the new calibration factors (Mean Factors) and Factor % Diff
values.
Compares the Factor % Diff values to ranges in an internal table to determine
which parameters require calibration.
Highlights Factor % Diff values for parameters which require calibration or
which are over-limit.
Manual Calibration
Select Calibration from the menu bar and Manual Calibration... on the pulldown menu and the Manual Calibration... dialog box opens.
6-22
Section 6
NOTE: This example of the Dilution Factor page

visible, is only available to users with administrative
privileges.
There are two tabs:

Calibration Factor
Dilution Factor
The Calibration Factor displays the current mode and parameter specific
calibration factors. See also Subsection: Manual Calibration Method.
The Dilution Factor displays the current mode and parameter specific Dilution
Factors, and is for use only by Abbott personnel. Users with administrative level
access are able to view the Dilution Factor page.
.
Table 6.7
Fields Manual Calibration... Dialog Box

Field
Comment
Table 6.8
OK
Cancel
Operator entered comment or remarks
Buttons Manual Calibration... Dialog Box
Buttons
Description
Description
Saves any changes or comments
Cancels the dialog box
6-23
Section 6
Calibration Menu
Four worksheets are provided to assist in manual calculation and determination of

new calibration factors for the CELL-DYN Ruby System. Three worksheets are
designed for the Open Mode procedure and one for confirmation. Refer to
Subsection: Manual Calibration Worksheets.
Worksheet 1 Open Mode Calibration New Factors
Worksheet 2 Open Mode Factor % Difference
Worksheet 3 Open Mode Calibration Range Criteria
Worksheet 4 Calibration Verification
6-24
Section 6
Overview
Before initiating calibration, complete the Pre-Calibration Procedures described
previously in this section.
The CELL-DYN Ruby System software applies the mode and parameter specific
calibration factor to the data obtained when the specimens are run. The
CELL-DYN Ruby provides the operator the option to initiate the Auto-Calibration
Wizard and Manual Calibration using Commercial Calibrator material or Assayed
Whole Blood specimens.
The Auto-Calibration Wizard method simplifies the generation of new calibration
factors for Commercial Calibrator or Assayed Whole Blood specimens. The
Manual Calibration method allows the operator to manually calculate and enter
new calibration factors generated from Commercial Calibrators or Assayed Whole
Blood Specimens.
NOTE: If a System Initiated Message (SIM) displays during the Auto-Calibration
Wizard or Manual Calibration method, refer to Section 10:
Troubleshooting and Diagnostics for the corrective action to perform
before running the next sample.
Auto-Calibration Method
Auto-Calibration is a multi-step process that involves:
Selecting Open or Closed mode for calibration
NOTE: Commercial Calibrator is for Open Mode use only.
Pre-Calibration Maintenance Check Status
Pre-Calibration Reagent and Waste Check
Pre-Calibration Precision Check Status
NOTE: It is recommended that the operator verify that both the primary
and secondary mode Quick Precision Checks have been completed
before beginning the Auto-Calibration Wizard.
Pre-Calibration Background Check Status
Selecting Calibration Setup Specimen Type
Entering Reference Values or Assay Values for Calibrator
Auto-Calibration Data View: Running calibrator specimens
Accepting or Rejecting calibrator runs
Reviewing and Activating Post Calibration New Factors
Auto-Calibration Wizard Open/Closed Mode Bias Check
6-25
Section 6
Running Mode to Mode Specimens in Primary Mode

Running Mode to Mode Specimens in Secondary Mode
Accepting or Rejecting Bias Check Runs
Reviewing and Activating Post Mode Check Factors (if required)
Printing Auto-Calibration Summary report
Run Controls to confirm calibration
Auto-Calibration Wizard - Open

Using Commercial Calibrator
When using a calibrator, follow the instructions provided on the calibrator package
insert for proper storage, handling, and mixing.
Abbott recommends cycling the calibrator a minimum of 6 and a maximum of 10
runs when using the Auto-Calibration Wizard in Open Mode.
Beginning Auto-Calibration
1. Verify the System is in Open Mode. If the System is in Closed Mode select
the F11Select Open function key to change from Closed to Open Mode.
2. Select Calibration and Auto-Calibration Wizard... from the pull-down
menu. The Auto-Calibration Wizard... dialog box opens.
6-26
Section 6
NOTE: The Sample Mode field displays the current Analyzer Status
mode when the dialog box opens.
Table 6.9
Buttons Welcome to the CELL-DYN Auto Calibration Wizard
Buttons
Description
Next>
Advances to the next dialog box
Cancel
Opens dialog box:

Cancel Auto-Calibration Wizard?
No, returns to the wizard
Yes, cancels the wizard
3. Select Next> and the Pre-Calibration Maintenance Check Status dialog

box opens. Read the information in the dialog box and follow the directions.
Table 6.10
Buttons Pre-Calibration Maintenance Check Status Dialog Box
Buttons
Perform
Maintenance
Description
Cancels the Wizard and displays the Maintenance,
Scheduled tab view
<Back
Returns to the previous screen
Next>
Advances to the next screen if maintenance is current

NOTE: When Maintenance Procedures are incomplete, the
information bar immediately above the Perform
Maintenance button displays a message:
Incomplete maintenance performed. Please enter a
comment to continue calibration.
6-27
Section 6
Table 6.10
Buttons Pre-Calibration Maintenance Check Status Dialog Box (Continued)
Buttons
Cancel
Description
Opens dialog box:
4. Click Next> and the Pre-Calibration Reagent/Waste dialog box opens.

Read the information in the dialog box and follow the directions.
Table 6.11
6-28
Buttons Pre-Calibration Reagent/Waste Dialog Box
Buttons
Description
Change Reagent
Cancels the wizard and displays the Reagents, Current

Reagents tabs view
<Back
Next>
Advances to the next screen
Cancel
Opens dialog box:

Finish
Completes an operation
Section 6
5. Click Next> and the Pre-Calibration Precision Check Status dialog box
opens. Review the information in the dialog box.
The date, time, and results of the most recent Quick Precision Check are
displayed, if available, in the Pre-Calibration Precision Check Status
dialog box.
Example: The last precision check was performed on the date listed
Table 6.12
Buttons
Description
New Precision Check
Opens a dialog box to exit the wizard and opens the

Quick Precision Check... dialog box
Buttons Pre-Calibration Precision Check Status Dialog Box
<Back
Next>
Advances to the next screen if a precision check was

performed within the last 24 hours and the status of
each parameter is PASS
NOTE: When Precision Check fails, the information
bar immediately above the New Precision
Check button displays a message:
Failed Precision Check. Please enter a
Cancel
Opens dialog box:

Finish
6-29
Section 6
Verify that the results of the last precision check are not greater than 24 hours
old and the Status column lists PASS, before advancing to the next screen.
See the dialog box below.
NOTE: If any of the following occurred, select the New Precision Check
button to exit the wizard and open the Quick Precision Check...
dialog box.
The A precision check was performed on field is blank,
indicating no precision check was performed
Any parameter status results indicate FAILED
The precision check is more than 24 hours old
Example: Field is empty - no date listed, no precision check performed
6. Click Next> and the Pre-Calibration Background Check Status dialog box
opens and starts the Auto Background cycle.
6-30
Section 6
A flashing blue/black message appears in the view: Pre-Calibration

Running Auto Background... and the message bar displays a message in
yellow: Wait.
In the Analyzer Status section, the State field turns yellow and the names of
the processes scroll across the bottom of the status bar area as each occurs:
Color
State
AutoBkg
AutoBkg
AutoBkg
AutoBkg
AutoBkg
AutoBkg
Ready
Scroll Bar
Aspirating
Removing Specimen
Dispensing
Counting
Rinsing
Rinsing
message scrolling area
The green light and the word Ready appear in the State field when the PreCalibration Background Check is completed.
The Pre-Calibration Background Check Status dialog box reveals a new
view.
6-31
Section 6
a. Read the information in the dialog box.

b. Verify that the Result column indicates PASS background counts are
within parameters before advancing to the next screen.
NOTE: If any parameter has a FAILED result, select Rerun
Background before advancing to the next step.
Table 6.13
6-32
Buttons Pre-Calibration Background Check Status Dialog Box
Buttons
Description
Rerun Background
Returns to the Pre-Calibration Background Check

Status dialog box and flashes message:
Pre-Calibration - Running Auto Background...
<Back
Next>
Advances to the next screen if all parameter results list

PASS
Cancel
Opens dialog box:

Finish
Section 6
7. Click Next> and the Calibration Setup dialog box opens. Read the
information in the dialog box and follow the directions. Verify that the
Calibrator radio button is selected.
Table 6.14
Buttons Calibration Setup Dialog Box
Buttons
Description
<Back
Next>
Cancel
Opens dialog box:

Finish
Inputting Calibrator Information

1. Click Next> and the Calibration Setup - Reference Values for Calibrator
dialog box opens. Read the information in the dialog box and follow the
directions.
6-33
Section 6
2. Using the calibrator assay sheet, input the information:

a. Find a parameter.
b. Select the same parameter on the screen.
c. Enter that parameters value on the screen. When entering assay values:
Check the parameter to make sure the parameter listed for the
Calibrator on the assay sheet matches the CELL-DYN Ruby.
Carefully check the assay values as the order in which they are listed
on the assay sheet may be different from the order on the screen.
NOTE: Use the Manual Calibration method to calibrate any parameter
with an assigned value that exceeds the assay value entry range.
Select a box in the Parameter column. The cursor positions itself in
the corresponding Value column.
NOTE: Scrolling over a check
box in the Parameter
column displays the
numerical range limit
for each parameter.
Assay Values:
After entering the last value, press the Enter key to save the entered
values.
Use the calibrator's vial label to enter the information shown in the
following table.
6-34
Section 6
Table 6.15
Fields Calibration Setup - Reference Values for Calibration

Fields
Specimen ID
(Calibrator ID)
Enter the Calibrator Lot Number
Lot Number
Enter the Calibrator Lot Number
Expiration Date
Enter the expiration date
Number of Runs for

Calibration
Enter the number of runs

NOTE: When using commercial calibrator, Abbott
recommends a minimum of 6 runs in
Open Mode.
Table 6.16
Buttons Calibration Setup - Reference Values for Calibration Dialog

Box
Buttons
Description
Description
<Back
Next >
Cancel
Opens dialog box:

Finish
6-35
Section 6
3. Click Next> and the Auto-Calibration Data View dialog box opens. The
Run# field displays the number of runs made over the number of runs
selected in the Calibration Setup - Reference Values for Calibrator
screen:
Accepted Run # X/x the accepted runs which increase each time a run
is completed.
Number of runs, Run # x/X set in the previous screen, Calibration
Setup - Reference Values for Calibrator.
6-36
Section 6
Running the Calibrator

1. Read and follow the directions in the Auto-Calibration Data View dialog
box before running the specimens.
a. Follow the instructions provided in the calibrator package insert for

proper handling and mixing procedure of the specimens.
b. Remove the cap from the vial.
c. Position the vial around the Open Mode probe keeping the tip of the
Open Mode probe from resting on the bottom of the tube.
d. Press the touch plate to activate aspiration of the specimen.
e. Remove the vial at the sound of the beep, before the wash block moves
down the Open Mode probe.
In the Analyzer Status section, the State field turns yellow and the
names of the processes scroll across the bottom of the status bar area as
each occurs:
.
Color
State
Ready
Counting
Counting
Counting
Counting
Counting
Cleaning
Ready
Scroll Bar
Aspirating
Removing Specimen
Dispensing
Counting
Rinsing
Rinsing
The data appears in the dialog box during the Counting-Rinsing process.
The green light and the word Ready appear in the State field when the
run is completed.
6-37
Section 6
When the run is ended, the Auto-Calibration Data View reflects the
information.
f.
Continue running specimens until the total number of runs are complete.
This is an example of Auto-Calibration Data View when the accepted
number of runs match the number of runs selected in the Calibration
Setup - Reference Values for Calibrator dialog box.
2. Review the calibrator run data. If the number of accepted runs equals the
number of selected runs, the Next> button is available. Select the Next>
button to advance to the next dialog box.
To reject a run:
a. Deselect or clear a check box. The Run# x/x reflects each change made.
In the previous example, if two boxes were deselected, then the runs
would be listed as 4/6. Two new specimens would need to be run to
replace the two deselected runs.
b. Run the missing number of specimens and review the calibrator run data.
Table 6.17
Buttons Auto-Calibration Data View Dialog Box
Buttons
6-38
Description
<Back
Next>
Advances to the next screen when the number of accepted runs

equals the number of selected runs.
Cancel
Opens dialog box:

Finish
Section 6
Review New Factors to Apply

1. Click Next> and the Post-Calibration New Factors dialog box opens.
Review the information in the dialog box.
Table 6.18
Fields Post-Calibration New Factors Dialog Box

Field
Cal. Recommended
Apply New Factor
Table 6.19
Description
Displays Yes or No
Applies the new factor to the next screen
Buttons Post-Calibration New Factors Dialog Box
Buttons
Description
<Back
Next>
Applies new factors and advances to the next screen
Cancel
Opens dialog box:

Finish
The dialog box provides an explanation of the information in the Cal

Recommended column.
Refer to Table 6.20 for guidance on when to select Apply New Factor for
acceptance.
6-39
Section 6
Table 6.20
When to Select Apply New Factor for Acceptance

And the parameter(s)
... the check

box <Apply
New Factor>
display/status
is:
Operator Action:
Selectable
Apply New Factor by selecting the check

box.
Continue with wizard.
YES
(green)
% Diff is within the

calibration range:
WOC >1.5% but <10%
NOC >1.5% but <10%
RBC >1.0% but <10%
HGB >1.0% but <10%
MCV >1.0% but <10%
MPV >1.0% but <10%
PLT >3.0% but <15%
Selectable
Apply New Factor ONLY if the reason for

the large % Diff is understood.
YES
(blue)
% Diff is greater than the

calibration range:
WOC >10%
NOC >10%
RBC >10%
HGB >10%
MCV >10%
MPV >10%
PLT >15%
% Diff is less than the
calibration range:
WOC <1.5%
NOC <1.5%
RBC <1.0%
HGB <1.0%
MCV <1.0%
MPV <1.0%
PLT <3.0%
Selectable
The parameter current Cal Factor is OK as

is. It is not required to select the Apply
New Factor check box.
If <Cal
Recommended>
message is:
NO
(green)
6-40
Section 6
Table 6.20
When to Select Apply New Factor for Acceptance (Continued)
NO
(red)
Calibration factor value

exceeds allowable range:
WOC 0.7001.300
NOC 0.7001.300
RBC 0.8001.200
HGB 0.7001.300
MCV 0.7001.300
PLT
0.7001.300
Not
selectable
DO NOT CALIBRATE.
If the parameter New Factor falls
outside the software allowable factor
range:
Select the < Back button twice.
Verify the Reference Values or Assay
Values entered are acceptable.
If the entered values are OK, select the
Cancel button to exit the wizard.
Rerun auto-calibration with new calibrator
specimen(s).
If the entered values are Not OK
Correct the value or values.
Select the Next > button twice.
Review the updated <Cal
Recommended> message.
2. To complete Auto-Calibration with the currently Calculated Factors, select

Finish>
or
To continue with Open/Closed Mode Bias Check, select Next>
The following dialog box opens:
Select <YES> to continue. The Open/Closed Mode Bias Start dialog box opens.
6-41
Section 6
Running the Open/Closed Mode Bias Check

You will need 6-10 fresh, normal whole blood specimens to perform the Open/
Closed Mode Bias Check.
1. Review the information in the Open/Closed Mode Bias Start dialog box.
The Primary mode is based upon the initial sampling mode for AutoCalibration.
Buttons
Description
<Back
Goes to previous page
Next >
Cancel
Opens dialog box:

No: returns to Wizard
Yes: cancels the Wizard
Finish
Returns to selected view
2. Select Next >. The Open/Closed Mode Bias Runs dialog box opens.
a. Read the information in the dialog box and follow the directions before
running the bias check specimens.
NOTE: Enter the specimen ID for Open Mode samples in the NOTE
region.
6-42
Section 6
3. Run the Bias Check specimens:

a. Run 6 10 normal whole blood specimens in the Open Mode.
b. Select F11 to change to the Closed Mode.
c. Run the same whole blood specimens in the Closed Mode.
d. To reject a run, deselect or clear the checkbox next to the run to be
rejected.
4. Select Next > to continue. The Open/Closed Mode Bias Results dialog box
opens.
6-43
Section 6
5. Review the Open/Closed Mode Bias results.

a. If the Open/Closed bias for a parameter is within tolerance range, the
parameter row will be shaded, and the Cal Rec and Apply columns will
be blank.
b. If the Open/Closed bias for a parameter exceeds the tolerance range, the
Cal Rec column will display Yes or No, and the Apply column will
contain a checkbox.
The dialog box provides an explanation of the information in the Cal Rec
column.
6. Select the checkbox(es) in the Apply column apply the New Factor(s).
7. Select Finish > to accept the new secondary mode factors. The AutoCalibration dialog box opens and indicates Auto-Calibration completed
Successfully!
6-44
Section 6
8. Click Print to print out and review the calibration summary report.
9. Click Close and the Auto Calibration Wizard closes.

10. Continue with Subsection: Post-Calibration Procedures.
Whole Blood Auto-Calibration Wizard - Open Mode

Using Whole Blood
When using whole blood, it is important to mix the specimen well by inverting the
tube at least ten times just prior to aspiration. Do not shake the specimen.
Abbott recommends cycling each of five whole blood specimens twice for a
total of at least ten times when using the Auto-Calibration Wizard in Open Mode.
See Subsection: Obtaining Whole Blood Reference Values from a Reference
Analyzer before beginning the procedure to auto-calibrate using whole blood.
Beginning Auto-Calibration Using Whole Blood
6-45
Section 6
2. Select Calibration and Auto-Calibration Wizard... from the pull-down

menu. The Auto-Calibration Wizard... dialog box opens.
NOTE: The Sample Mode field displays the current Analyzer

Status mode when the dialog box opens.
Table 6.21
Buttons Welcome to the CELL-DYN Auto-Calibration Wizard Dialog

Box
Buttons
6-46
Description
Next>
Advances to the next dialog box
Cancel
Opens dialog box:

Section 6
3. Select Next> and the Pre-Calibration Maintenance Check Status dialog

box opens. Read the information in the dialog box and follow the directions.
Table 6.22
Buttons Pre-Calibration Maintenance Check Status Dialog Box
Buttons
Perform
Maintenance
Description
Cancels the Wizard and displays the Maintenance,
Scheduled tab view
<Back
Next>
Advances to the next screen if maintenance is current

NOTE: When Maintenance Procedures are incomplete,
the information bar immediately above the
Perform Maintenance button displays a
message:
Incomplete maintenance performed. Please enter
a comment to continue calibration.
Cancel
Opens dialog box:

6-47
Section 6
4. Click Next> and the Pre-Calibration Reagent/Waste dialog box opens.

Read the information in the dialog box and follow the directions.
Table 6.23
6-48
Buttons Pre-Calibration Reagent/Waste Dialog Box
Buttons
Description
Change Reagent
Cancels the wizard and displays the Reagents, Current

Reagents tabs view
<Back
Next>
Cancel
Opens dialog box:

Finish
Section 6
5. Click Next> and the Pre-Calibration Precision Check Status dialog box
opens. Review the information in the dialog box.
dialog box.
Example: The last precision check was performed on the date listed
Table 6.24
Buttons
Description
New Precision Check
Opens a dialog box to exit the wizard and opens the

Quick Precision Check... dialog box
Buttons Pre-Calibration Precision Check Status Dialog Box
<Back
Next>
Advances to the next screen if a precision check was

performed within the last 24 hours and the status of
each parameter is PASS
NOTE: When Precision Check fails, the information
bar immediately above the New Precision
Check button displays a message:
Failed Precision Check. Please enter a
Cancel
Opens dialog box:

Finish
6-49
Section 6
Verify that the results of the last precision check are not greater than 24 hours
old and the Status column lists PASS, indicating parameters are calibrated,
before advancing to the next screen.
NOTE: If any of the following occurred, select the New Precision Check...
button to exit the wizard and open the Quick Precision Check
dialog box.
The A precision check was performed on field is blank,
indicating no precision check was performed
Example: Field is empty - no date listed, no precision check performed
6-50
Section 6
6. Click Next> and the Pre-Calibration Background Check Status dialog box

Running Auto Background... and the message bar displays a message in
yellow: Wait.
In the Analyzer Status section, the State field turns yellow and the names of
the processes scroll across the bottom of the status bar area as each occurs:
1
Color
State
AutoBkg
AutoBkg
AutoBkg
AutoBkg
AutoBkg
AutoBkg
Ready
Scroll Bar
Aspirating
Removing Specimen
Dispensing
Counting
Rinsing
Rinsing
message scrolling area
The green light and the word Ready appear in the State field when the PreCalibration Background Check is completed.
6-51
Section 6
The Pre-Calibration Background Check Status dialog box reveals a new

view.

b. Verify that the Result column indicates PASS background counts are
within parameters before advancing to the next screen.
NOTE: If any parameter has a FAILED result, select Rerun
Background before advancing to the next step.
Table 6.25
6-52
Buttons Pre-Calibration Background Check Status Dialog Box
Buttons
Description
Rerun Background
Returns to the Pre-Calibration Background Check

Status dialog box and flashes message:
Pre-Calibration - Running Auto Background...
<Back
Next>
Advances to the next screen if all parameter results

list PASS
Cancel
Opens dialog box:

Finish
Section 6
7. Click Next> and the Calibration Setup dialog box opens. Read the
information in the dialog box and follow the directions. Verify that the Whole
Blood radio button is selected.
Table 6.26
Buttons Calibration Setup Dialog Box
Buttons
Description
<Back
Next>
Cancel
Opens dialog box:

Finish
Inputting Whole Blood Information

1. Select Next> and Calibration Setup - Reference Values for Whole Blood
dialog box opens. Read the information in the dialog box and this step and
follow the directions.
6-53
Section 6
Table 6.27
Buttons Calibration Setup - Reference Values for Whole Blood

Dialog Box
Buttons
Description
<Back
Next>
Advances to next screen
Cancel
Opens dialog box:

Finish
2. Using the Whole Blood Calibration Reference Values Worksheet, input the
information:
a. Enter Reference Values
1) Find a parameter, cumulative mean value on the worksheet.
2) Select the same parameter on the screen.
3) Enter that parameters value on the screen. When entering reference
values:
Select a box in the Parameter column. The cursor positions
itself in the corresponding Value column.
After entering the last value, press the Enter key to save the
entered values.
6-54
Section 6
NOTE: Scrolling over a check box in

the Parameter column displays
the numerical range limit for
each parameter.
Assay Values:
b. Enter Specimens Used for Reference and Calibration

1) Enter the Specimen ID in the field just above the Add button.
Specimen ID entered here . . .

Click Add . . .
Specimen ID appears in the Specimen ID field
2)
Click Add and the information is entered into the Specimen ID

field. Repeat steps 1 and 2 for each Specimen ID being run.
c. Using the Whole Blood Calibration Reference Values Worksheet, verify
the number of runs per specimen for calibration.
d. Enter source of Reference Values

1) Enter the Reference Instrument from the worksheet.
6-55
Section 6
Running the Whole Blood Specimens

1. Click Next> and Auto-Calibration Data View dialog box opens.
Number of runs completed / total number of runs to be made
Reference
Values entered
in the
Calibration
Setup dialog
box
Table 6.28
Buttons Auto-Calibration Data View Dialog Box
Buttons
Description
<Back
Next>
Button isnt operative when counts are running but is after

a count is through running
Cancel
Opens dialog box:

Finish
The reference values entered in the prior step appear in the Auto-Calibration
Data View.
The Run# field displays the number of:
Run# X/xCompleted and/or selected runs
Number of runs Run# x/X set in the previous screen, Calibration
Setup - Reference Values for Whole Blood.
Read and follow the directions in the Auto Calibration Data View dialog
box to run the specimens.
6-56
Section 6
2. Using the Whole Blood Calibration Reference Values Worksheet as a guide:

a. Go to the NOTE region.
b. At the Specimen ID or QCID field pull-down
menu, select the Specimen ID to be run.
c. Verify the specimen ID on the tube label
matches the specimen ID field in the NOTE
region.
3. Aspirate the specimen:
a. Properly mix and remove the cap from the
tube.
b. Position the vial around the Open Mode probe keeping the tip of the
Open Mode probe from resting on the bottom of the tube.
c. Press the touch plate to activate aspiration of the specimen.
d. Remove the vial, at the sound of the beep, before the wash block moves
down the Open Mode probe.
Each sample goes through the following process:
In the Analyzer Status section, the State field turns yellow and the
names of the processes scroll across the bottom of the status bar area as
each occurs:
.
Color
State
Ready
Counting
Counting
Counting
Counting
Counting
Cleaning
Ready
Scroll Bar
Aspirating
Removing Specimen
Dispensing
Counting
Rinsing
Rinsing
The data appears in the chart during the Counting-Rinsing process.

The green light and Ready appear in the State field when each run is
completed.
e. Run the specimen the assigned number of runs. When all calibration
specimens have been run, select the Next> button to advance to the next
dialog box.
6-57
Section 6
Review New Factors to Apply

1. Click Next> and the Post-Calibration New Factors dialog box opens.
Review the information in the dialog box.
The dialog box provides an explanation of the information in the Cal

Recommended column. Refer to Table 6.31 for guidance on when to select Apply
New Factor for acceptance.
Table 6.29
Fields Post-Calibration New Factors Dialog Box

Field
Cal. Recommended
Apply New Factor
.
Table 6.30
Displays Yes or No
Applies the new factor to the next screen
Buttons Post-Calibration New Factors Dialog Box
Buttons
6-58
Description
Description
<Back
Next>
Applies new factors and advances to the next

screen
Cancel
Opens dialog box:

Finish
Completes Auto-Calibration without BIAS check
Section 6
Table 6.31
When to Select Apply New Factor for Acceptance

And the parameter(s)
... the check

box <Apply
New Factor>
display/status
is:
Operator Action:
Selectable
Apply New Factor by selecting the check

box.
YES
(green)
% Diff is within the

calibration range:
WOC >1.5% but <10%
NOC >1.5% but <10%
RBC >1.0% but <10%
HGB >1.0% but <10%
MCV >1.0% but <10%
PLT >3.0% but <15%
Selectable
Apply New Factor ONLY if the reason for

the large % Diff is understood.
Continue with Wizard.
YES
(blue)
% Diff is greater than the

calibration range:
WOC >10%
NOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
% Diff is less than the
calibration range:
WOC <1.5%
NOC <1.5%
RBC <1.0%
HGB <1.0%
MCV <1.0%
PLT <3.0%
Selectable
The parameter current Cal Factor is OK as

is, it is not required to select the Apply New
Factor check box Continue with wizard.
If <Cal
Recommended>
message is:
NO
(green)
6-59
Section 6
Table 6.31
When to Select Apply New Factor for Acceptance (Continued)
NO
(red)
6-60
Calibration factor value

exceeds allowable range:
WOC 0.7001.300
NOC 0.7001.300
RBC 0.8001.200
HGB 0.7001.300
MCV 0.7001.300
PLT
0.7001.300
Not
selectable
DO NOT CALIBRATE.
If the parameter New Factor falls
outside the software allowable factor
range:
Select the < Back button twice.
Verify the Reference Values or Assay
Values entered are acceptable.
If the entered values are OK, select the
Cancel button to exit the wizard.
Rerun auto-calibration with new calibrator
specimen(s).
If the entered values are Not OK:
Correct the value or values.
Select the Next > button twice.
Review the updated <Cal
Recommended> message.
Section 6
Running the Open/Closed Mode Bias Check

You will need 6-10 fresh, normal whole blood specimens to perform the Open/
Closed Mode Bias Check.
1. Review the information in the Open/Closed Mode Bias Start dialog box.
The Primary mode is based upon the initial sampling mode for AutoCalibration.
Buttons
Description
<Back
Goes to previous page
Next >
Cancel
Opens dialog box:

No: returns to Wizard
Yes: cancels the Wizard
Finish
Returns to selected view
2. Select Next >. The Open/Closed Mode Bias Runs dialog box opens.
a. Read the information in the dialog box and follow the directions before
running the bias check specimens.
NOTE: Enter the specimen ID for Open Mode samples in the NOTE
region.
6-61
Section 6
3. Run the Bias Check specimens:

a. Run 6 10 normal whole blood specimens in the Open Mode
b. Select F11 to change to the Closed Mode.
c. Run the same whole blood specimens in the Closed Mode.
d. To reject a run, deselect or clear the checkbox next to the run to be
rejected.
4. Select Next > to continue. The Open/Closed Mode Bias Results dialog box
opens.
6-62
Section 6
5. Review the Open/Closed Mode Bias results.

be blank.
contain a checkbox.
The dialog box provides an explanation of the information in the Cal Rec
column.
6. Select the checkbox(es) in the Apply column apply the New Factor(s).
7. Select Finish> to accept the new secondary mode factors. The AutoCalibration dialog box opens and indicates Auto-Calibration completed
Successfully!
6-63
Section 6
8. Click Print to print out and review the calibration summary report.
9. Click Close and the Auto Calibration Wizard closes.

10. Continue with Subsection: Post-Calibration Procedures.
6-64
Section 6
Running the Calibration Bias Wizard
You will need 6 to 10 fresh, normal whole blood specimens to perform the Open/
Closed Mode Bias Check, using the Calibration Bias Wizard.
1. Select Calibration Bias Wizard from the pull-down Calibration menu.
The Calibration Bias Wizard dialog box opens, showing the Welcome
screen. Select the Primary Sample Mode.
2. Select Next and the Pre-Calibration Maintenance Check Status screen

displays. Read the information and follow the directions.
3. Click Next and the Pre-Calibration Reagent/Waste screen displays. Read

the information and follow the directions.
6-65
Section 6
4. Click Next and the Pre-Calibration Precision Check Status screen

displays.
dialog box.
Verify that the results of the last precision check are not greater than 24 hours old
and the Status column lists PASS before advancing to the next screen. See the
dialog box below.
NOTE: if any of the following occurred, select the New Precision Check button
to exit the wizard and open the Quick Precision Check dialog box.
The A precision check was performed on field is blank, indicating no
precision check was performed.
6-66
Section 6
5. Click Next and the Pre-Calibration Background Check Status screen

Running Auto Background and the message bar displays a message in
yellow: Wait.
6. When the Auto Background is complete, the Pre-Calibration Background

Check Status dialog reveals a new view.
6-67
Section 6

b. Verify that the Result column indicates PASSbackground counts are
within parametersbefore advancing to the next screen.
NOTE: If any parameter has a FAILED result, select Rerun Background before
advancing to the next step.
7. Select Next. The Open/Closed Mode Bias Start dialog box displays.
6-68
Section 6
8. Select Next. The Open/Closed Mode Bias Runs dialog box opens.
a.
b.
c.
NOTE:
Run 6 to 10 normal whole blood specimens in the Closed Mode.

Select F11 to change to the Open Mode.
Run the same whole blood specimens in the Open Mode.
Enter the Specimen ID for Open Mode samples in the NOTE region.
NOTE: To reject a run, deselect or clear the checkbox next to the run to be
rejected.
9. If you do not use 6 (minimum) closed specimens and you select Next, an
error message displays in the bulletin line at the bottom of the dialog box.
6-69
Section 6
NOTE: An equal number of Open and Closed Specimens must be processed in

order to proceed with the Calibration Bias Wizard.
10. Select Next to display the Open/Closed Mode Bias Results screen.
6-70
Section 6
11. Review the Open/Closed Mode Bias Results.

be blank.
contain a checkbox.
12. If required, select the checkbox(es) in the Apply column to apply the New
Factor(s).
13. Select Finish to accept the new secondary mode factors. The AutoCalibration dialog box opens and indicates Calibration Bias completed
Successfully!
14. Click Print to print out and review the calibration summary report, or click
Finish to exit the Calibration Bias Wizard.
6-71
Section 6
Manual Calibration Method

The Manual Calibration method can be used to enter a predetermined factor to
adjust calibration when a consistent bias exists between the CELL-DYN Ruby
System and a comparison analyzer. Either Commercial Calibrator or Assayed
Whole Blood can be used for calibration.
When using Assayed Whole Blood begin with a sufficient amount of sample
15 mL each is recommended the same sample is used to obtain reference values
on a reference instrument and to calibrate in the Open and verify the Closed Modes.
A set of worksheets is provided in Manual Calibration Worksheets at the end of
this section to assist in the manual calibration process.
NOTE: Always complete Pre-Calibration procedures before beginning any
calibration.
Manual Calibration Dialog Box

When Manual Calibration is selected from the Calibration menu bar, the
Manual Calibration... dialog box is displayed with two tab views: Calibration
Factor and Dilution Factor. New calibration factors can be manually entered on the
Calibration Factor tab view.
NOTE: This example of the Dilution Factor page
visible, is only available to users with administrative
privileges.
6-72
Section 6
Manual Calibration Primary Mode - Open

Using Commercial Calibrator or Whole Blood
Use the following procedures to manually calibrate the instrument in the Open
Mode:
Determining New Calibration Factors
Determining Which Parameters Need Calibration
Entering New Calibration Factors
Determining New Calibration Factors
2. Select Calibration from the menu bar and Manual Calibration from the
pull-down menu to open the Manual Calibration dialog box. The
Calibration Factor tab, which is the default tab, opens and displays the
current calibration factors.
3. Select the Print Scrn key on the keyboard to obtain a printout of the factors.
4. Select Calibration from the menu bar and Quick Precision Check from
the pull-down menu and the Quick Precision Check dialog box opens.
5. Use commercial calibrator or assayed whole blood, following directions set
forth in this step.
Commercial Calibrator
a. Follow the mixing instructions found in the package insert.
b. Enter the Calibrator Lot Number in the <Specimen ID> field and run the
calibrator a minimum of 6 times.
c. Select the Print button to obtain a printout of the mean values to be used
with Worksheet 1 Open Mode Calibration - New Factors.
Assayed Whole Blood
a. Obtain the same five specimens used to obtain the reference values.
b. Mix well by gently inverting the tube a minimum of ten times. Do not
shake the specimen.
c. Run each specimen twice, entering the Specimen ID in the Specimen ID
field as each is being run.
d. Select the Print button to obtain a printout of the mean values to be used
with Worksheet 1 Open Mode Calibration - New Factors.
6. Using Worksheet 1 Open Mode Calibration - New Factors, provided in
Manual Calibration Worksheets, determine the New Calibration Factor for
each parameter using either commercial calibrator or assayed whole blood.
6-73
Section 6
For Commercial Calibrator

Using the values on the assay sheet and the CELL-DYN mean values
determined in step 5 above, enter the information in columns 1 and 2
respectively of Worksheet 1 Open Mode Calibration - New Factors,
Open Mode Calibration New Factors, provided in Manual Calibration
Worksheets at the end of this section.
For Assayed Whole Blood
Using the Reference Mean Values determined in Obtaining Whole Blood
Reference Values from a Reference Analyzer described earlier (refer to the
Whole Blood Calibration Reference Values Worksheet) and the CELL-DYN
mean values determined in step 4 above, enter the information in columns 1
and 2 respectively of Worksheet 1, Open Mode Calibration New Factors,
provided in Manual Calibration Worksheets at the end of this section.
7. Using the printout obtained in Step 3 above, enter the Open Calibration
Factors to column 3 of Worksheet 1.
Follow the instructions on Worksheet 1 to calculate the new Open Mode
Calibration Factor for each parameter and enter the information in column
4 of the worksheet.
The method for determining the new factors is:
a. Calibrator Calibration
Assay Value
--------------------------------------------- Current Open Mode = New Open Mode
Calibration Factor
Calibration Factor
CELL-DYN Mean
b. Whole Blood Calibration

Reference Mean
--------------------------------------------- Current Open Mode = New Open Mode
Calibration Factor
Calibration Factor
CELL-DYN Mean
For example, if the Reference Mean Value for WOC is 6.6, the CELL-DYN
Mean for WOC is 7.1, and the current Open Mode Calibration Factor for
WOC is 0.98, then:
(6.6 / 7.1) 0.981 = 0.912
and 0.912 is your New Open Mode Calibration Factor for WOC.
6-74
Section 6
Determining Which Parameters Need Calibration

To determine which parameters require calibration in the Open Mode, follow the
procedure below using Worksheet 2 Open Mode Factor % Difference and
Worksheet 3 Open Mode Calibration Range Criteria provided in Manual
Calibration Worksheets at the end of this section.
1. Transfer the values from column 4 of Worksheet 1 to the New Open Mode
Factor column 1 of Worksheet 2, Open Mode Factor % Difference.
2. Transfer the values for the Current Open Mode Cal factor from column 3 of
Worksheet 1 and enter these values in columns 2 and 3 of Worksheet 2.
3. Follow the instructions on this worksheet to determine the Factor % Diff for
each parameter.
4. Transfer the Factor % Diff values from column 5 (calculated in Worksheet 2)
to column 1 of Worksheet 3, Open Mode Calibration Range Criteria.
5. For each parameter, if the Factor % Diff is equal to or less than the value in
the Lower Limit column, then CALIBRATION IS NOT REQUIRED for that
parameter because the value is within range.
6. For each parameter, if the Factor % Diff falls between the upper and lower
calibration range, shown in the Calibration Range column, then
CALIBRATION IS REQUIRED.
7. For each parameter, if the Factor % Diff is greater than the value in the
Upper Limit column, there may be a computation error or an instrument
problem. In this case, do the following:
a. Recheck all numbers and calculations on Worksheets 1 and 2.
b. Determine if any component on the instrument was changed. This could
affect calibration. Such components include the Shear Valve, Optical
Flow Cell, Hemoglobin Flow Cell, or one of the syringes.
c. If a component was changed, then treat the result as if it fell within the
calibration range (even though it is greater than the upper limit).
CALIBRATION IS REQUIRED for that parameter.
d. If no component was changed and your calculations are correct, DO
NOT CALIBRATE. Confirm that all Pre-Calibration procedures were
completed and contact your local Country Service representative for
assistance.
6-75
Section 6
Entering New Calibration Factors

Based on the results from Worksheet 3 column 5 and using Worksheet 2 column 1:
For parameter(s) that calibration is required:
1. Select Calibration, Manual Calibration from the menu bar to display the
2. Using Worksheet 2 column 1, enter the New Open Mode Factor(s) for the
associated parameter(s) that calibration is required (Worksheet 3 column 5)
in the Open Factor column, Manual Calibration, Calibration Factor tab view.
3. For the parameter(s) updated, copy the Open Factor to the Closed Factor
column to match the Open Factor column, then select the OK button.
4. Select the System view, Calibration Log tab, and use the F1 Print to
obtain a copy of the Calibration Log.
5. Proceed to Subsection: Post-Calibration Procedures.
If none of the parameters requires calibration:
1. Select Calibration, Manual Calibration from the menu bar to display the
2. Enter text in the Comment field, Manual Calibration, Calibration Factor tab
view, indicating no factors require change, then select the OK button.
3. Select the System view, Calibration Log tab, and use the F1 Print to
obtain a copy of the Calibration Log.
4. Proceed to Subsection: Post-Calibration Procedures.
6-76
Section 6
Confirm calibration by running at least two levels of controls. CELL-DYN Ruby
results should now be within your laboratorys established acceptance range.
(Refer to Section 11: Quality Control for instructions on running controls.) If
control results are not within the acceptable range, troubleshoot accordingly. If
necessary, contact your local Country Service and Support Center for assistance.
Refer to Section 11: Quality Control, Subsection: Guidelines for Running
Controls for information on day-to-day verification of System calibration.
Backing Up Calibration Factors

It is recommended that the calibration factors be printed and saved on backup
media whenever calibration is changed. Each laboratory should establish its own
procedures for determining when to restore the information.
General Concepts and Guidelines

NOTE: Each backup process requires new media to copy the current
information to. See Section 1: Use or Function, Subsection:
System Components, Analyzer Right Side for details on the type
of backup media to use.
Properly label the media and store it in a safe location.
All setup information, including the calibration factors, is backed up from the
hard drive to the media. Individual settings or categories of information
cannot be backed up selectively.
Backup Procedure
The following is the procedure for backing up calibration factors and analyzer
setpoints.
NOTE: Before beginning the backup procedure, printing hard copies of the
Manual Calibration, calibration factors and the Calibration Log is
recommended.
PROCEDURE: BACKING UP CALIBRATION FACTORS
2. From the menu bar, select File, Backup . The Backup dialog box opens.
6-77
Section 6
3. Place a labeled floppy disk (at least one megabyte) in the disk drive.
4. In the Backup to floppy field, select the Start Backup button. The dialog
box will indicate the status.
NOTE: If there is not enough space on the disk the message: Not enough space
for backup on the floppy disk displays.
5. When backup is complete, the message: Backup Completed successfully
displays.
6. Remove the floppy disk from the disk drive and store it in a safe location.
PROCEDURE: RESTORING CALIBRATION FACTORS
2. Insert the floppy disk containing calibration factors into the floppy drive.
3. From the menu bar, select File, Restore . The Restore dialog box opens.
6-78
Section 6
4. In the Restore from floppy field, select the Start Restore button.
5. After all files are restored a message box appears:
Application will close to complete the restore. Restart the application to
continue.
6. Remove the floppy and select Yes. The application will close. The system
will reboot and restart.
NOTE: For the procedure to backup/restore System Data including the Data Log,
refer to Section 5: Operating Instructions, Subsection: Post-Analysis
Processing Datalog View.
6-79
Section 6
Manual Calibration Worksheets

Four worksheets are provided to assist in the calculation of calibration factors for
the CELL-DYN Ruby System. Three worksheets are designed for the Open Mode
procedure and one worksheet for calibration verification.
Worksheet 1 Open Mode Calibration New Factors
Make copies of these worksheets as necessary.
6-80
Section 6
Worksheet 1 Open Mode Calibration - New Factors

Instrument:________________________
Date: ________________
Operator:____________
Calculate All Factors To Three Decimal Places

(1)
Assay Value
or
Ref Mean
(2)
Open Mode
Mean
(3)
Current
Open Mode
Cal Factor
(4)
New
Open Mode
Cal Factor
(5)
Range
WOC
0.7001.300
NOC
0.7001.300
RBC
0.8001.200
HGB
0.7001.300
MCV
0.7001.300
PLT
0.7001.300
1. In column 1, enter the calibrator assay values or the whole blood reference means that were used in the
calibration process. Use the same WBC Reference Value for WOC and NOC.
2. In column 2, enter the mean values calculated in the Quick Precision Check... dialog.
3. In column 3, enter the current Open Factor calibration factors from the Manual Calibration... dialog print
screen.
4. For each parameter, divide the value in column 1 by the value in column 2 and multiply the result by the
value in column 3.
5. The value calculated in step 4 is the new calibration factor. Write this value in column 4.
6. Compare the new calibration factor in column 4 with the range shown in column 5. If the new factor falls
within the range, go to Worksheet 2. If the new factor falls outside the range, check all calculations. If
necessary, run the samples again into a new Quick Precision Check dialog and perform new calculations.
6-81
Section 6

Instrument:________________________
Date: ________________
Operator:____________
Calculate All Factors To Three Decimal Places

(1)
New Open
Mode Factor
(2)
Current Open
Mode Factor
(4)
(3)
Current Open
Mode Factor
x 100 =
WOC
x 100 =
NOC
x 100 =
RBC
x 100 =
HGB
x 100 =
MCV
x 100 =
PLT
x 100 =
(5)
Factor
% Diff
1. In column 1, enter the new factor calculated in column 4 of Worksheet 1.

2. In columns 2 and 3, enter the current Open Factor calibration factors from the Manual Calibration...
dialog print screen.
3. Subtract the current factor in column 2 from the new factor in column 1, divide the result by the current
factor in column 3, multiply the result by 100 and enter the result in column 5.
6-82
Section 6
Instrument:________________________
(1)
Factor
% Diff
Date: ________________
Operator:____________
(2)
Lower Limit
Cal Not Required
(3)
Calibration Range
Cal Required
(4)
Upper Limit
Do Not Cal
WOC
<1.5%
>1.5% but <10%
>10%
NOC
<1.5%
>1.5% but <10%
>10%
RBC
<1.0%
>1.0% but <10%
>10%
HGB
<1.0%
>1.0% but <10%
>10%
MCV
<1.0%
>1.0% but <10%
>10%
PLT
<3.0%
>3.0% but <15%
>15%
(5)
Cal? Y/N
1. In column 1, enter the new Factor % Diff from column 5 of Worksheet 2 (disregard the sign).
2. If the new Factor % Diff exceeds the limit in column 4, DO NOT CALIBRATE. Confirm that all PreCalibration procedures were completed, review Determining Which Parameters Need Calibration and
contact your local Country Service and Support Center for assistance.
6-83
Section 6

Instrument Serial Number Software Version:____________Date: ________________Operator ID ______________
Part 1 Primary Mode:

Using:
Whole Blood
Sample #
Sampling Mode:
WOC
Open Mode
Closed Mode
NOC
Results within tolerance:
RBC
HGB
MCV
Pass
Fail
PLT
Mean Value of Runs

Reference or Assay Value
Difference (absolute value)
Tolerance Limits *
* For Calibrator, use the pre-established tolerance limits found on the Calibrator Assay sheet. The Calibration value is for Open Mode use only. For Whole
Blood, each laboratory should establish tolerance limits according to its protocol.
Part 2 Secondary Mode:

Using:
Whole Blood
Sample #
Sampling Mode:
WOC
Open Mode
Closed Mode
NOC
RBC
Results within tolerance:

HGB
MCV
Pass
Fail
PLT
Mean Value of Runs

Reference or Assay Value
Difference (absolute value)
Tolerance Limits *
* For Calibrator, use the pre-established tolerance limits found on the Calibrator Assay sheet. The Calibration value is for Open Mode use only. For Whole
Blood, each laboratory should establish tolerance limits according to its protocol.
1. Enter the mean value from the Quick Precision Check... for commercial calibrator or whole blood runs.
2. Enter the reference values or assay values used to calibrate those parameters.
3. Calculate and enter the Difference (absolute value) between the Mean and Reference or Assay Value.
4. Enter the Tolerance Limits and compare the Difference with the Tolerance Limits.
5. If the Difference is within the limit, continue to complete calibration verification by running at least two
levels of Quality Control specimens and verify to be within acceptable limits prior to reporting patient
results.
6. If the Difference is outside the limits, recheck all numbers and calculations and contact your local Country
Service and Support Center for assistance.
6-84
Section 6
References
1. International Committee for Standardization in Haematology (ICSH).
Protocol for Evaluation of Automated Blood Cell Counters. Clinical and
Laboratory Hematology 1984; 6:69-84.
2. Clinical and Laboratory Standards Institute (CLSI). Procedure for
Determining Packed Cell Volume by the Microhematocrit Method; Approved
Standard - Third Edition. CLSI Document H7-A3
[ISBN 1-56238-413-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2000.
6-85
Section 6
References
NOTES
6-86
Section 7 Operational Precautions and Limitations
Section 7
Overview
The CELL-DYN Ruby is designed for in vitro diagnostic use only.
This section addresses operational requirements, precautions, and limitations to
ensure operator safety and accurate test results. Failure to follow these
requirements or take these precautions may cause damage to the system, impact
system performance or adversely affect results, or present a hazard to the operator.
Operational precautions and limitations topics include:
General requirements
Lists the requirements for system environment, maintenance, and
troubleshooting to ensure proper system performance.
Precautions and requirements for system operation.
Lists the precautions you should take and the requirements you should follow
before and during system operation.
Requirements for handling consumables.
Lists the requirements for storing and using consumables such as reagents,
calibrators, and controls.
Requirements for handling specimens.
Lists the requirements for collecting, preparing, and storing specimens.
Interfering Substances and Conditions.
Limitations of result interpretation.
Discusses the other factors you should consider when interpreting patient test
results.
7-1

Section 7
Overview
General Requirements
You MUST follow these general CELL-DYN Ruby System requirements to help
ensure proper system performance:
Contact your Abbott representative to install your CELL-DYN Ruby System.
The CELL-DYN Ruby instrument employs a Microsoft Windows Operating
System. Any software added to the system other than specified by Abbott
Laboratories may interfere with the correct function of the analyzer and is not
recommended.
Do not save any files to the Data Station hard drive, as it may affect
instrument performance.
Ensure the system is out of direct sunlight, heat and drafts, and away from
any heat-generating device. Exposure to heat and drafts can interfere with the
ability of the system to maintain an operating temperature that is within the
acceptable range.
Place the CELL-DYN Ruby Analyzer on a hard, level surface. Maintain the
required space on all sides of the system. For more information about space
requirements, see Section 4: Performance Characteristics and
Specifications, Subsection: Clearance Requirements. This clearance is
essential for:
Adequate ventilation and cooling of electrical components
Easy access for maintenance
Easy access for disconnecting the power cord when required
Place the CELL-DYN Ruby Analyzer away from centrifuges, x-ray
equipment, and copiers.
NOTE: The CELL-DYN Ruby has been evaluated to EN 55011 and
EN 61000 for electromagnetic emissions and immunity,
respectively.
CAUTION: Do not use mobile telephones, wireless telephones, mobile
radios, or any other radio-frequency (RF) transmitting devices in the same
room as the instrument.
Leave the system power on continuously unless instructed otherwise in a
maintenance or troubleshooting procedure, or unless an emergency situation
occurs.
Ensure Analyzer waste line is connected to the appropriate Analyzer outlet
and is routed to a suitable waste container or drain.
If an external waste container is used, ensure that the top of the external waste
container is placed below the bottom of the Analyzer.
7-2
Section 7
WARNING: Potential Biohazard. If the System is allowed to go into

Standby after performing the Auto-Clean procedure and the instrument is
connected to an external waste container, verify that the waste container is
at least two-thirds empty prior to running the Auto-Clean procedure.
If a drain is used for waste, ensure that the Waste Outlet Tube is secured in
the drain hole. Ensure that System components are located away from
potential waste overflow.
Perform maintenance procedures as recommended in Section 9: Service and
Maintenance.
Do not attempt any maintenance or repairs that are not specified in
documentation provided by Abbott Laboratories. An Abbott-authorized
representative must perform all major service work or the warranty could be
voided.
CELL-DYN Ruby components are designed specifically for use with the
CELL-DYN Ruby. Substitution of unauthorized components may adversely
affect the performance of the system.
Precautions and Requirements for System Operation

You MUST take these precautions and follow these requirements when operating
the CELL-DYN Ruby System. Failure to do so may cause damage to the system
and may adversely affect test results.
Precautions Before Operation

Before you begin operating the system, you should:
Read this manual thoroughly to understand the full functionality of the
system and associated hazards.
Read the sections of the reagent manufacturers documentation (such as a
package insert) specific to:
Warnings and precautions
Safety precautions
Handling precautions
Requirements Before Operation
Before you begin operating the system:
DO NOT run open tubes in the Closed Mode.
Ensure that Auto Background and background counts are within acceptable
limits before running controls and patient specimens.
7-3

Section 7
Overview
Specimens run in the Open Mode must be premixed according to your

laboratorys procedure. Specimens collected in micro-collection tubes should
be premixed according to the collection device manufacturers
recommendations.
WARNING: DO NOT use any Specimen ID for a hematology specimen
that contains any of the following characters: |, \, ^, and &. These
characters will cause the Specimen ID to be truncated at the point where the
character is located within the ID. This action will result in an erroneous
Specimen ID for the downloaded Pending Orders entry or for the record
received by the LIS, without any error notification.
Precautions During Operation

While operating the system, take the following precautions:
Keep all instrument covers in place unless instructed otherwise in a
maintenance or troubleshooting procedure.
Do not disconnect any electrical connection while the power is on.
Respond to system initiated messages relating to waste levels during
processing. Dispose of all liquid waste according to local, state, and federal
regulations.
WARNING: Potential Biohazard. If the System is allowed to go into
Standby after performing the Auto-Clean procedure and the instrument is
connected to an external waste container, verify that the waste container is
at least two-thirds empty prior to running the Auto-Clean procedure to
prevent an overflow of waste.
Do not select any menu bar options unless specifically requested to do so in
this manual or by an authorized Abbott representative.
Do not select any Diagnostic menu bar options unless specifically requested
to do so in this manual or by an authorized Abbott representative.
Requirements for Handling Consumables

You MUST follow these requirements when handling consumables to help ensure
your safety and accurate assay results. See the reagent (such as a package insert,
product label, or Material Safety Data Sheet (MSDS) for detailed information. For
a description of the hazard symbols, see Section 8: Hazards.
Requirements for Storage
Follow these requirements for storing reagents, calibrators, and controls:
Store reagents, calibrators, and controls according to directions in the
manufacturers documentation (such as a package insert or label
recommendation).
7-4
Section 7
Protect reagents from extreme heat and freezing during storage.

Temperatures below 0C (32F) can cause layering, which changes the
tonicity and conductivity of the reagent. Do not use reagents that have been
frozen.
Contact your Abbott Country Service and Support Center if you receive
reagents, calibrators, or controls that are in a condition contrary to the
products documentation (such as a package insert or label recommendation),
or that are damaged.
Requirements for Use
Follow these requirements for using reagents, calibrators, and controls:
Do not substitute. Substitution of materials may affect CELL-DYN Ruby
System performance, results, safety, and equipment life.
Keep the tops of the reagent containers lower than the bottom of the
Analyzer.
Keep reagents away from direct sunlight and protect them from evaporation.
Use the reagent container cap attached to each inlet tube. The cap will
minimize evaporation and contamination.
Use caution when handling reagents, calibrators, and controls to prevent
contamination and operator exposure.
Refer to the manufacturers documentation for reagent, calibrator, and
control temperature requirements and handing instructions prior to using the
product on the CELL-DYN Ruby.
Wear clean gloves to avoid contamination and operator exposure when
removing and replacing the reagent inlet lines in uncapped reagent
containers.
Never add reagent from one container to that in another.
Do not smoke, eat, drink, apply cosmetics, or handle contact lenses in areas
where specimens, reagents, calibrators, and controls are handled.
Do not use reagents, calibrators, and controls beyond their expiration dates.
Do not mix reagents, calibrators, and controls within a lot or between lots.
Verify the lot number and expiration date of the Reticulocyte Reagent
according to the manufacturers documentation (such as package insert)
before Open Mode use on the CELL-DYN Ruby.
7-5

Section 7
Overview
Requirements for Handling Specimens

Consider all clinical specimens, reagents, calibrators, and controls that contain
human-sourced materials as potentially infectious. Consider all system surfaces or
components that have come in contact with human-sourced materials as potentially
infectious. Refer to Section 8: Hazards, for additional information.
WARNING: Potential Biohazard. Identifies an activity or area where
you may be exposed to potentially infectious material.
Collect all specimens according to your laboratorys procedures, following the

recommendations of the collection tube manufacturer. Follow all usual precautions
while collecting blood by venipuncture or capillary puncture to avoid clotting
and/or specimen hemolysis.
Requirements for Preparation and Storage
Follow these requirements for preparing and storing specimens:
The following specimen collection tube dimensions are recommended for
use in the Closed mode:
Table 7.1
Recommended Collection Tube Dimensions for Use in Closed Mode

Collection Tube Dimensions
11.5-13 mm diameter x 65-75 mm long
Rack
Refer to Appendix A:
for rack information.
NOTE: To ensure satisfactory operation, no other specimen tube dimensions are

recommended for use in the Closed Mode. All other dimensions should
be run in the Open Mode. Refer to Section 4: Performance
Characteristics and Specifications, Subsection: Recommended
Specimen Collection Tubes (Closed Mode).
All performance claims given in this manual were generated using specimens
collected in K2EDTA. Results may be affected by the use of other
anticoagulants. Each laboratory should develop protocols for handling
specimens collected in anticoagulants other than K2EDTA.
In the Closed mode, ensure that the specimen volume is at least 1.2 mL in
standard collection tubes. Refer to Section 4: Performance Characteristics
and Specifications, Subsection: Recommended Specimen Collection Tubes
(Closed Mode).
In the Open mode, ensure that the specimen volume is at least 0.5 mL (500L)
in standard collection tubes, and 0.18 mL (180L) in micro-collection tubes.
Refer to Section 4: Performance Characteristics and Specifications,
Subsection: Recommended Volume Requirements in Specimen Collection
Tube.
7-6
Section 7
Use fresh, whole blood specimens to achieve the most reliable result data.
The International Committee for Standardization in Haematology (ICSH)
defines a fresh blood specimen as one processed within four hours after
collection.1
A higher incidence of false positive morphological flags may occur for
specimens analyzed at higher ambient temperatures within the operating
range of 15C to 30C (59F to 86F). The reported numerical results are not
affected.
Specimen stability after collection of venous whole blood:
Specimens run within eight hours of collection:
Room Temperature storage is recommended
Specimens run more than eight hours after collection:
Refrigerated (28C) storage is recommended
Any refrigerator-stored specimens should be brought to room temperature
before mixing and processing.
Stability studies show that when specimens stored at room temperature
before mixing and processing, average results for the WBC, RBC, HGB,
MCV and PLT are stable (5.4%) for up to 24 hours after collection. An
increase in false-positive Suspect Population Flags may be seen on
samples processed more than 4 hours after collection time.
For information on specimen stability for specimens collected using
micro-collection devices, refer to the collection tube manufacturers
package insert.
7-7

Section 7
Overview
Interfering Substances and Conditions

It is important to note that there are commonly occurring interfering substances that
can affect the results reported by hematology analyzers. While the
CELL-DYN Ruby has been designed to detect and flag many of these substances,
it may not always be possible to do so. The following indicates some of the
substances that may interfere with each of the listed parameters.
WBC: Fragile WBC, neutrophil aggregates, lytic-resistant RBC, NRBC, PLT
clumps, cryofibrinogen, cryoglobulin, paraproteins
RBC: Elevated WBC count, increased numbers of giant PLT, autoagglutination, in
vitro hemolysis
HGB: Elevated WBC count, increased plasma substances (triglycerides, bilirubin,
in vivo hemolysis), lytic-resistant RBC
MCV: Elevated WBC count, hyperglycemia, in vitro hemolysis, increased
numbers of giant PLT
PLT: WBC fragments, in vitro hemolysis, microcytic RBC, cryofibrinogen,
cryoglobulins, PLT clumping, increased numbers of giant PLT
NOTE: This list is neither all-inclusive or non-exclusive. All potential interferents
have not been formally tested by Abbott. It is important to note that there
are commonly-occurring interfering substances that can affect the results
reported by hematology analyzers. See Appendix B: Potential Causes of
Spurious Results for a list of potential causes of spurious results with
automated hematology analyzers.
For a detailed description of the flags that are generated, refer to Section 3:
Principles of Operation, Subsection: Operational Messages and Data Flagging.
Limitations of Result Interpretation

The CELL-DYN Ruby has been validated for its intended use. However, error can
occur due to potential operator errors and CELL-DYN Ruby System technology
limitations. Results obtained on the CELL-DYN Ruby MUST be used with other
clinical data, for example, symptoms, other test results, patient history, clinical
impressions, information available from clinical evaluation, and other diagnostic
procedures. All data MUST be considered for patient care management. If the
results are inconsistent with clinical evidence, additional testing is suggested to
confirm the result.
7-8
Section 7
Reference
1. International Committee for Standardization in Haematology (ICSH).
Protocol for Evaluation of Automated Blood Cell Counters. Clinical and
Laboratory Hematology 1984; 6:69-84.
7-9

Section 7
Reference
NOTES
7-10
Section 8 Hazards
Section 8
Hazards
Overview
This section provides information on potential hazards to personnel and potential
damage to the laboratory environment.
Hazard and safety topics include:
Safety icons
Provides an illustration of each safety icon and sample text associated with
the icon.
Laser caution labels
Provides an illustration of the caution labels found on the system.
Hazard symbols
Provides an illustration of each hazard symbol and a description along with
its standard abbreviation.
Biological and chemical hazards
Provides an overview of the biological and chemical hazards you may be
exposed to and the precautions you should take to minimize exposure to these
hazards.
Electrical hazards
Provides an overview of precautions you should take to avoid personal injury
or damage to the system from its electrical components.
Mechanical hazards
Provides an overview of the precautions you should take to avoid personal
injury or damage to the system from its mechanical components.
Physical hazards
Provides an overview of the precautions you should take to avoid physical
injury when operating or moving the system.
8-1
Hazards
Section 8
Overview
Operator Responsibility
You are responsible for using the CELL-DYN Ruby System only as designed.
Operators must be trained before being allowed to operate the system. Failure to
follow safe-use instructions could cause personal injury, damage to the system, or
could adversely affect results. See also Section 7: Operational Precautions and
Limitations.
Safety Icons
Safety icons in this manual and on the CELL-DYN Ruby identify potentially
dangerous conditions. You MUST recognize the icons and understand the type and
degree of potential hazard they represent.
The following icons may be used with text or in lieu of text. If text accompanies
the icons, it describes the nature of the hazard and is labeled with WARNING or
CAUTION.
WARNING: is defined as a physical, mechanical, or procedural condition that
could result in moderate to serious personal injury.
CAUTION: is defined as a condition that could result in minor injury or interfere
with proper functioning of the system.
Table 8.1
Icon
8-2
Safety Icons and Descriptions
Hazard
Description
WARNING: Potential Biohazard
Identifies an activity or area where operators may be

exposed to potentially infectious material.
WARNING: Electrical Shock

Hazard
Indicates the possibility of electrical shock if

procedural or engineering controls are not observed.
CAUTION: Class 3B laser light

when open. Avoid exposure to beam.
Warns against direct viewing of the beam or

reflections from the beam.
CAUTION:
Identifies an activity that may present a safety related

hazard, and advises you to consult the associated
caution or warning instructions provided.
Section 8
Hazards
Laser Caution Labels

Laser caution labels must not be removed and are to be kept legible. If label(s)
become illegible, notify your Country Service and Support Representative. The
following labels shown consist of black lettering against a yellow background and
are affixed to the CELL-DYN Ruby. See Figure 8.3 for an illustration depicting
laser label placement.
CLASS 1 LASER PRODUCT/
Lasergert der Klasse 1/
Produit laser de classe 1/Lser de
clase 1/Prodotto laser di classe 1/
Produto laser da classe 1/Klasse 1laserprodukt/Klass 1 laserprodukt/
1 PN 9230702C
Figure 8.1
Class 1 Laser Product Label
The label is affixed on the rear panel of the instrument.

exposure to beam.
3
.
.
PN 9230701F
Figure 8.2
Laser Warning Label
The label is affixed to the upper left front flow panel and inside the Analyzer on top
of the optics protective cover of the optics bench assembly.
8-3
Hazards
Section 8
Overview

exposure to beam.
3
.
.
PN 9230701F
Figure 8.3
8-4
CELL-DYN Ruby System Laser Caution Labeling
Section 8
Hazards
Hazard Symbols
CELL-DYN Ruby product labeling may include the following hazard symbol. The
symbol conveys properties of the chemical or chemical mixture, and notifies you
that you should take precautions when working with the material.
Table 8.2
Hazard Symbol
Hazard Symbol
Description (with Standard Abbreviation)

This symbol indicates that some of the component(s) in the product has Harmful (Xn) or
Irritant (Xi) properties.
Biological and Chemical Hazards

You may be exposed to biological materials and hazardous chemicals while using
the CELL-DYN Ruby. The following information is presented to help you
minimize the likelihood and degree of impact of any such exposure.
Biological and chemical hazard topics include:
Biological hazards
Chemical hazards
Spill clean-up
Waste handling and disposal
Decontamination procedure requirements
Biological Hazards
The following activities may involve the presence of biological materials:
Handling patient specimens, reagents, calibrators, and controls
Cleaning spills
Handling and disposing of waste
Moving the system
Performing maintenance procedures
Performing decontamination procedures
Performing component replacement procedures
WARNING: Potential Biohazard. Identifies an activity or area where
you may be exposed to potentially infectious material.
8-5
Hazards
Section 8
Overview
Precautions
You should consider all clinical samples, reagents, calibrators, and controls that
contain human-sourced material as potentially infectious. You should consider all
system surfaces or components that have come in contact with human-sourced
material potentially infectious. No known test method can offer complete
assurance that products derived from human-sourced material will not transmit
infection. Therefore, all products derived from human-sourced materials and
system components exposed to human-sourced materials should be considered
potentially infectious.
It is recommended that you handle all potentially infectious materials in
accordance with the Standard on Bloodborne Pathogens.1 You should use
Biosafety Level 22 or appropriate biosafety practices3,4 for materials that contain or
are suspected of containing infectious agents. Precautions include, but are not
limited to, the following:
Wear gloves, lab coats, and protective eye wear when handling humansourced material or contaminated system components.
Do not pipette by mouth.
Do not eat, drink, smoke, apply cosmetics, or handle contact lenses when
handling human-sourced material or contaminated system components.
Clean spills of potentially infectious materials and contaminated system
components with an appropriate disinfectant, such as 0.5% sodium
hypochlorite, refer to Section 9: Service and Maintenance, Subsection:
Decontamination Procedures.
Decontaminate and dispose of all specimens, reagents, calibrators, controls,
and other potentially contaminated materials in accordance with local, state,
and federal regulations.
If you are exposed to biohazardous or potentially infectious materials, you should
seek medical attention immediately and take steps to cleanse the affected area.
8-6
Section 8
Hazards
Chemical Hazards
You may be exposed to hazardous chemicals when handling reagents, calibrators,
and controls.
Your exposure to hazardous chemicals is minimized by following instructions
provided in the manufacturers documentation (such as the product insert), on
product labels, and on product-specific Material Safety Data Sheets (MSDS).
Precautions
In general, observe the following precautions when handling chemicals:
Consult MSDS for safe-use instructions and precautions.
Avoid contact with skin and eyes. If contact with material is anticipated, wear
impervious gloves, protective eye wear and clothing.
Maintain good housekeeping. Do not eat, drink, or store food and beverages
in areas where chemicals are used.
Seek medical attention if irritation or signs of toxicity occur after exposure.
Hazard symbols that appear on CELL-DYN Ruby product labeling are
accompanied by risk (R) and safety (S) numbers and represent risk and safety
phrases defined by European Community Directives. The risk and safety phrases
describe precautions you should use when working with a particular chemical or
chemical mixture.
For information related to Article 33 of the EU REACH regulation
(EC No.1907/2006), please refer to http://pmis.abbott.com/pmis/home.html.
WARNING: This product contains chemicals known to the State of
California to cause cancer and/or birth defects or other reproductive harm.
Spill Clean-Up
Clean spills in accordance with established biosafety practices. In general, use
these safe work practices for cleaning spills:
1.
2.
3.
4.
Wear appropriate personal protective equipment.

Absorb the spill with absorbent material.
Wipe the spill area with detergent cleaning solution.
Wipe the area clean with an appropriate disinfectant such as 0.5% sodium
hypochlorite, refer to Section 9: Service and Maintenance, Subsection:
Decontamination Procedures. Allow at least 10 minutes of contact time
before wiping the area.
5. Dispose of spilled and contaminated material in accordance with local, state,
and federal regulations.
8-7
Hazards
Section 8
Overview
Waste Handling and Disposal

Dispose of all waste materials in accordance with local, state, and federal
regulations.
It is the responsibility of each facility to label all waste containers and to
characterize its waste stream to ensure the waste is disposed in accordance with the
appropriate waste disposal regulations.
Disposing of Batteries
The European Battery Directive requires separate collection of spent batteries,
aiming to facilitate recycling and to protect the environment.
This device contains batteries that are not intended to be serviced or removed by
the user. The batteries in this product should be removed at the end of the life of the
device by an Abbott Service technician or a qualified individual, and disposed in
accordance with local regulations for separate collection of spent batteries.
Your local Abbott product support office may be contacted for additional
information.
Decontamination Procedure Requirements

The CELL-DYN Ruby must be decontaminated before shipment or relocation.
Always wear appropriate personal protective equipment while performing
decontamination activities. Refer to Section 9: Service and Maintenance,
Subsection: Decontamination Procedures for procedures that describe
preparation for shipment and decontamination.
Electrical Hazards
The CELL-DYN Ruby does not pose uncommon electrical hazards to operators if
it is installed and operated without alteration, and is connected to a power source
that meets required specifications. See Section 4: Performance Characteristics
and Specifications, Subsection: Power Specifications.
The electrical circuit spacing of the CELL-DYN Ruby is based on pollution degree
(2) and altitude [up to 2000 M (6500 ft)] as per IEC 61010-1.5 Pollution degree 2
is defined as an environment where normally only non-conductive pollution
occurs. Occasionally, however, a temporary conductivity caused by condensation
must be expected.
Electrical Safety
WARNING: Indicates the possibility of electrical shock if procedural or
engineering controls are not observed.
Basic electrical hazard awareness is essential to the safe operation of any system.
Only qualified personnel should perform electrical servicing. If the instrument is
used or modified in a manner not specified by the manufacturer, the protection
provided by the instrument may be impaired.
8-8
Section 8
Hazards
Elements of electrical safety include, but are not limited to, the following:
Inspect electrical cabling into and on the CELL-DYN Ruby for signs of wear
and damage.
Use only approved power cords and electrical accessories, such as those
supplied with the system, to protect against electric shock.
Use a properly grounded electrical outlet of correct voltage- and currenthandling capability.
Do not disconnect any electrical connection or service any electrical or
internal components while the power is on.
Keep liquids away from all electrical or communication component
connectors.
Do not touch with wet hands any switches or outlets.
Keep the floor under and around the CELL-DYN Ruby dry and clean.
Clean spilled fluids immediately.
8-9
Hazards
Overview
Section 8
Mechanical Hazards
The CELL-DYN Ruby is an automated system that operates under computer
control. As with most automated equipment, there is potential for injury and bodily
harm from moving mechanical components whenever the system is in operation.
The CELL-DYN Ruby minimizes mechanical hazards by providing protective
covers, protection guards, and encoding the software with safety features to protect
against accidental contact with mechanical and moving components.
The CELL-DYN Ruby requires accurate placement of all samples, reagents,
calibrators, and controls on the system. It is very important that reagent tubes,
patient specimens, calibrators, and controls are accurately placed in the sample
loader racks or presented to the system, as described in Physical Hazards, before
initiating any operation. It is NEVER acceptable to attempt to reach into the
processing area when the system is in operating mode. Should operator
intervention be necessary during a run, interrupt the run according to instructions
defined in Section 5: Operating Instructions, Subsection: Interruption
Procedures.
8-10
Section 8
Hazards
During operation of the CELL-DYN Ruby, the operator is potentially exposed to the following:
Moving Mechanical Components:
Sample Loader
Wash Block Open Mode Probe
Syringe Drive Assemblies
Peristaltic Transfer Pumps
Shear Valve Assembly
Y-Valve Assembly
Fan
Mechanical Components:
Wash Block - Closed Mode Needle
Mixhead Assembly
Basic elements of mechanical safety include:
Never bypass or override a safety device.
Keep all protective covers in place.
Never allow any part of the body to enter the region of movement of any
mechanical component when the system is operating.
Never perform manual tasks on the surface of the system.
Open or remove covers only as directed during scheduled and as-needed
maintenance, and component troubleshooting and consumable removal and
replacement procedures described in Section 9: Service and Maintenance
and Section 10: Troubleshooting and Diagnostics. If covers are opened
when access is not indicated, the mechanical components do not stop
moving.
Wear powder-free gloves when operating the instrument and when
performing maintenance or service procedures.
Use caution when loading racks on to the sample loader. Do not run open
tubes in the Closed Mode.
Use caution when performing maintenance, cleaning, or consumable
removal and replacement procedures, always using protective equipment
when specified.
Do not wear long hair loose or articles of clothing or accessories that could
catch on the system.
Keep pockets free of items that could fall into the system.
In the event of a system malfunction or an unexpected sequence of
movements, operator reflex actions could occur and cause injury.
8-11
Hazards
Overview
Section 8
Physical Hazards
Safe practices should be observed to avoid physical injury in the following
situations:
Aspiration Probes (Open Mode Probes) and
Vent Needles (Closed Mode Needles)
WARNING: Potential Biohazard. Aspiration probes and vent needles
are potentially contaminated with infectious material. Vent needle tips are
sharp; avoid contact with needle tips. Avoid contact with the tips of probes.
Dispose of aspiration probes and vent needles in an appropriately labeled,
puncture-resistant, and leakproof container before treatment and disposal.
Exposure to Laser Light
The CELL-DYN Ruby is a Class 1 (Class l) Laser Product per IEC 60825-16;
however, it contains a Class 3 B laser.
CAUTION: Class 3 B Laser Light when open. Avoid exposure to beam.
CAUTION: Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous laser light
exposure.
During normal operation, the Optics bench assembly resides inside an inner
protective cover. The inner protective cover is to remain in place to prevent laser
light exposure from the Optics bench. The inner protective cover is to be removed
only during servicing by a qualified Abbott Service Representative. The
Helium-Neon laser power up to 10 mW continuous wave at 632.8 nm is a beam
with a 1 mR divergence, could be accessible in the interior of the optics bench. Do
not look directly into the laser beam or any reflections of the beam from a mirrorlike surface. This amount of energy, with insignificant attenuation over distance, is
sufficient to cause eye damage.
Heavy Objects
CAUTION: Identifies an activity where you may be required to lift or
move a heavy object. Use proper lifting techniques.
The CELL-DYN Ruby Reagent containers are heavy when full. Use proper lifting
techniques to reduce the risk of injury when handling the containers.
The CELL-DYN Ruby is heavy. Ensure that you have adequate help before
attempting to move the system.
Tripping Hazard
The CELL-DYN Ruby is equipped with power cords and various computer
connectors. To avoid a tripping hazard, ensure that cords in high traffic areas are
properly stowed.
8-12
Section 8
Hazards
References
1. US Department of Labor, Occupational Safety and Health Administration, 29
CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological
and Biomedical Laboratories, Fourth Edition. Washington, DC: US
Government Printing Office, May 1999.
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World
Health Organization, 1993.
4. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
Second Edition. CLSI document M29-A2 (ISBN 1-56238-453-8). CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2001.
5. IEC 61010-1, International Electrotechnical Commission World
Standards for Electrical and Electronic Engineering, 61010: Safety
Requirements for Electrical Equipment for Measurement, Control, and
Laboratory Use, 61010-1 (2001) Part 1: General Requirements.
6. IEC 60825-1, International Electrotechnical Commission World
Standards for Electrical and Electronic Engineering, 60825: Safety of
Laser Products, 60825-1 (1993) Part 1: Equipment Classification,
Requirements, and Users Guide.
7. Directive 2006/66/EC of the European Parliament and of the Council of 6
September 2006 on batteries and accumulators and waste batteries and
accumulators and repealing Directive 91/157/EEC.
8-13
Hazards
Section 8
References
NOTES
8-14
Section 9 Service and Maintenance
Section 9
Overview
The CELL-DYN Ruby is designed to require minimal routine maintenance.
However, it is important to regularly perform the recommended maintenance
procedures to ensure instrument precision, accuracy, and reliability. Performing
these maintenance procedures will do the following:
Maximize data reliability
Minimize downtime
Aid in problem prevention and troubleshooting
Preventive maintenance of equipment under warranty will be performed by a
trained Abbott representative. Customers with questions concerning maintenance
can call the local Country Service and Support Center.
This section of the manual provides:
A schedule of recommended service and maintenance procedures
A description of the service and maintenance software windows
Step-by-step instructions for performing service and maintenance procedures
For information on parts and accessories, refer to Appendix A: Parts and
Accessories. Refer to Section 1: Use or Function for additional illustrations of
instrument components.
9-1

Section 9
Overview
NOTES
9-2
Section 9
Recommended Service and Maintenance Schedule

Perform the scheduled procedures at the intervals recommended in the following
tables; perform the as-needed procedures as indicated by laboratory needs. For
instructions on performing the procedures, refer to Subsection: Scheduled
Maintenance Procedures, As-Needed Maintenance Procedures within this
section.
WARNING: Potential Biohazard. Consider all specimens, reagents,
calibrators and controls or other materials that contain or contacted humansourced material as potentially infectious. Wear lab coats, protective
eyewear and gloves. Follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent
biosafety practices.
NOTE: After performing most service and maintenance procedures, it is
important to verify instrument performance by running and verifying
control recovery.
9-3

Recommended Service and Maintenance Schedule
Table 9.1
Section 9
Scheduled Service and Maintenance Procedures

Daily Procedure
6001 Auto-Clean
Weekly Procedure
6002 Clean Loader
Components
Monthly Procedures
6003 Inspect Syringes
6005 Replace Transfer Pump
Tubing
6006 Clean Shear Valve
6007 Replace Dil/Sheath Filter
6008 Extended Auto-Clean
It is recommended that this scheduled maintenance activity be performed on a weekly basis if your laboratory is running the Reticulocyte
assay.
Table 9.2
As-Needed Service and Maintenance Procedures
As-Needed Procedures
6055 Clean Fan Filter
6051 Clean Bar Code Reader
Window
6052 Clean or Replace Open
Mode Probe
6053 Clean or Replace Closed
Mode Needle
6054 Clean or Replace
Syringe
Table 9.3
Nonscheduled Service and Maintenance Procedures
Nonscheduled Procedures
Decontamination Procedures
Printer Cleaning
Reagent Container
Replacement
Replace Tubing in Normally
Closed (NC) Valves
Unclogging Open Mode Probe
Vacuum Accumulator 1 and 2
Rinsing Procedure
NOTE: The list of Nonscheduled maintenance tasks that the operator may perform are not based on time,
cycles, or scheduled intervals managed by the System software. See also Subsection: Nonscheduled
9-4
Section 9
Service and Maintenance Software

The following views for performing and recording service and maintenance
procedures are available on the CELL-DYN Ruby:
Maintenance view
Scheduled
As-Needed
Special Protocols
Maintenance Log
System view
Calibration Log
Event Log
Set-Point Log
Reagents view
Current Reagents
Reagent Log
9-5

Section 9
Maintenance View
The CELL-DYN Ruby System software provides a user-friendly interface for
performing and tracking your maintenance activities. The Maintenance view
provides access to procedure tasks that are scheduled to be performed based on a
time interval or cycle count criteria or as-needed. Once you select a task button and
initiate a procedure, dialog box instructions will guide you through its completion
including an on-line Help button that links specifically to the detailed procedure
instructions contained in this operators manual. Some procedures have a video
button that links to a video clip that demonstrates the procedure. Each dialog box
instruction also contains an <Enter Comment> field for the operator to document
any remarks during the activity. Performance and comments entered for a
scheduled or as-needed procedure are tracked in the Maintenance log.
NOTE: Refer to previous Table 9.3 for the list of Nonscheduled maintenance
tasks that the operator may perform that are not based on time, cycles, or
scheduled intervals managed by the System software. See also
Subsection: Nonscheduled Maintenance Procedures.
The Maintenance view provides access to tabs:
Scheduled maintenance tasks
As-Needed maintenance tasks
Special Protocols
Maintenance Log
Scheduled Maintenance Tasks

The Scheduled tab of the Maintenance view displays the scheduled maintenance
task buttons and also shows the:
Current Cycle Count: the cumulative total of instrument processing runs for
which a Datalog entry was created.
Setup Interval: time and cycle interval the task is scheduled to be
performed.
NOTE: The Setup Interval may be customized for Scheduled Maintenance
tasks with a default time frequency of weekly or monthly. To
change the Setup Interval, click on the arrow next to the time and
select the desired frequency from the display choices. A scheduled
maintenance task may be set to occur more frequently than the
default, but cannot be changed to occur less frequently.
Last Performed: date, cycle count, and operator ID when the task was last
completed.
Maintenance Due: date and cycles left before the maintenance procedure is
past due. Maintenance Due tasks will be highlighted in orange when the date
and cycles left are past due.
Refer to previous Table 9.1 for the list of Scheduled maintenance tasks.
9-6
Section 9
As-Needed Maintenance Tasks

The As-Needed tab of the Maintenance view displays the as-needed maintenance
task buttons and also shows the:
Current Cycle Count: the cumulative total of instrument processing runs for
which a Datalog entry was created.
Last Performed: date, cycle count, and operator ID when the task was last
completed.
Refer to previous Table 9.2 for the list of As-Needed maintenance tasks.
Special Protocols
The Special Protocols tab of the Maintenance view allows the operator to activate
important activities including Initialize Analyzer, Prime, and To Standby. Once you
select a Special Protocol task button and initiate a procedure, dialog box
instructions will guide you through its completion, including an on-line Help
button that links specifically to the detailed procedure instructions contained in this
operators manual. Each dialog box instruction also contains an <Enter
Comment> field for the operator to document any remarks during the activity.
Performance and comments entered for a Special Protocol activity are tracked in
the System Event log. The following table lists the Special Protocols that can be
activated in this view:
Table 9.4
Special Protocols
Button
Result
7000 To Standby
Analyzer is placed in Standby State. When standby is complete, System

Shutdown can be executed.
7001 Initialize Analyzer
Analyzer is placed in Initialized State. When initialization is complete, the

Analyzer can then be Primed.
NOTE: This activity can be performed only in the Open Mode.
7002 Disable/Enable
Analyzer
Analyzer is placed in Maintenance State and returned to the current state

prior to disabling.
7003 Prime
Activates System prime, runs Auto Background, and brings

Analyzer to Ready State.
NOTE: During Analyzer power on, this same activity can be activated by
selecting the F12 Prime button. Ensure that background counts
are within acceptable limits before running controls and patient
specimens.
7004 Empty/Fill Optical

Flow Cell
Activates the draining and filling of diluent/sheath reagent in the Optical

Flow Cell.
9-7

Section 9
Table 9.4
Special Protocols (Continued)
7005 System Shutdown
Powers off the data module and instrument without first entering Standby.
NOTE: This same activity can also be activated by selecting File, then
Shutdown from the menu bar.
7006 Drain Accumulator
Activates draining of the internal vacuum accumulators and places the

Analyzer in Uninitialized State. When the protocol is complete the system
must be Initialized and Primed.
NOTE: Ensure that background counts are within acceptable limits before
running controls and patient specimens.
7007 Empty/Fill Reagent

Reservoir
Activates the drain and filling of either the WBC Lyse reservoir, HGB Lyse
line tubing, or the Diluent/Sheath reservoirs, and places the Analyzer in
Ready State.
7008 Flush Closed Needle
Activates automatic flushing of the closed mode needle.

NOTE: This activity can be performed only in the Closed Mode.
7009 Prepare for Shipping
Prepares Analyzer for shipment, prolonged periods of non-use, and powers

off the System, or can be executed if instrument contamination is
suspected.
Maintenance Log
The Maintenance Log tab of the Maintenance view displays a record of all
scheduled and as-needed maintenance activities performed on the instrument, up
to 10,000 entries. Once 10,000 entries have been reached, the oldest record is
deleted when a new record is added.
The Maintenance Log displays:
Rec #: maintenance log record number
Maintenance Task: name of the scheduled or as-needed maintenance task
Type: Scheduled (Daily, weekly, Monthly) or As-Needed
Date Completed: date maintenance activity was performed
Cycle Count: instrument cycle count when the task was completed
OPID: operator ID when the task was completed
Comments: operator entered comment remarks when the activity was
performed
NOTE: The comment field is not editable and is for print and display purposes
only.
9-8
Section 9
F1 Print
F1 Print can be selected to display the Print dialog box while in the
Maintenance Log view.
These print options can be selected:
Record range: (1) All (2) Selection and (3) Start Rec# End#
Number of copies.
NOTE: When the F1 Print button is selected, if the layout of this view exceeds
the printer page orientation setup (Portrait) under File, Print Setup, the
system software will notify you to adjust the layout before the system can
print. If the printer page orientation setup is already set to Landscape and
the software still notifies you to adjust the layout, unless the log you are
trying to print is customizable, you can only utilize the Print Scrn button
from the keyboard to obtain a printout of what is displayed.
F3 Find/Filter
F3 Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log. Refer to Section 5:
Operating Instructions, Table 5.15 for more details on its use.
System View
The System view contains a set of logs that automatically store a chronological
history of system processes or functions that can be used to track the systems
performance.
The System view provides access to tabs:
Calibration Log
Event Log
Set Point Log
Calibration Log
The Calibration Log tab of the System view is a data repository containing the
chronological history of the changes made to the Calibration Factors. This
Calibration Log also contains the history of changes made to the Dilution Factors,
which are intended for use by Abbott field service and support representatives and
are not directly intended for use by the operator.
Refer to Section 6: Calibration Procedures for a description of the Calibration
Log.
F1 Print
F1 Print can be selected to display the Print dialog box while in the Calibration
Log view.
9-9

Section 9

Record range: (1) All (2) Selection and (3) Start Rec# End#
Number of copies
F3 Find/Filter
Event Log
The Event Log tab in the System view is a data repository containing the history
of the system's processes, functions, and faults in chronological order, along with
the date and time of each occurrence, up to 10,000 records. Once 10,000 records
have been reached, the oldest record is deleted when a new record is added. Each
Event Log record can be selected (by double-clicking) to display the Event
Properties dialog box that allows the operator to add or edit remarks in the
<Comment> field and to view the before and after details of Edit/Change event
types.
The Event Log displays:
Rec#: event log record number.
Event Type:
Event Type
Icons
Information
Warning
OCF (Operator Correctable Fault)
SL Fault (Sample Loader)
Fatal Fault
Edit/Change
Date_Time: date and time the event occurred on the system.

SIM#: system initiated message number.
NOTE: For the complete list of SIM numbers see Section 10:
Troubleshooting and Diagnostics, Subsection: List of System
Messages.
Message: text string associated with the system event that occurred.
OPID: operator ID when the system event occurred.
Comment: operator entered comment remarks.
9-10
Section 9
F1 Print
F1 Print can be selected to display the Print dialog box while in the Event Log
view.
Record range: (1) All (2) Selection and (3) Start Rec# End#.
Number of copies.
F3 Find/Filter
you to search and sort the information contained in the log.
Refer to Section 5: Operating Instructions, Table 5.15 for more details on its use.
Set Point Log

The Set Point Log tab in the System view is a data repository containing the
chronological history of changes to many of the instrument diagnostics settings
(e.g. gain settings, thresholds, pressure/vacuum settings) and related
configurations. The Set Point Log is intended for use by Abbott field service and
support representatives and is not directly intended for use by operators.
F1 Print
NOTE: The Set Point Log can only be printed using the Print Scrn button from
the keyboard to obtain a printout of what is displayed. While F1 Print
can be selected in the Set Point Log view, the software will continue to
notify you to adjust the layout before the system can print this log because
the number of columns exceeds the printer page orientation of both
Portrait and Landscape printing.
F3 Find/Filter
9-11

Section 9
Reagents View
The CELL-DYN Ruby System software provides a user-friendly interface for
viewing System reagent volume status, creating a new reagent entry, and tracking
the history of reagent usage on the instrument.
The Reagents view provides access to tabs:
Current Reagents
Reagent Log
Current Reagents
The Current Reagents tab of the Reagents view displays a graphical
representation of the percentage of reagent remaining for each reagent installed on
the system. Whenever the System or operator performs any function that uses
reagent, such as maintenance, calibration, and specimen processing, the amount of
reagent used will be mathematically subtracted from percentage of reagent
remaining and will update the graphical display. The System software provides an
early warning message based on this calculation when each reagent used on the
system has less than ten percent left.
NOTE: This calculation is only an approximation.
NOTE: If replacing reagents on the System before a reagent empty message is
generated, it is important for the operator to create an associated New
Reagent Entry for the reagent replaced to maintain an up to date Current
Reagents view volume status.
After replacing the reagent, select Maintenance View, Special Protocols, Prime,
to move the new reagent into the system.
The Current Reagents view also displays for each reagent used on the System:
Lot Number: lot number of the reagent container.
List Number: reagent product number.
Package Size: reagent container configuration volume.
Expiration Date: reagent expiration date (YYYY/MM/DD).
Open Date: date the container was placed on the System.
Comment: operator entered comment remarks.
F1 Print
NOTE: The Current Reagents view can only be printed using the Print Scrn
button from the keyboard to obtain a printout of what is displayed. While
F1 Print can be selected to display the Print dialog box while in the
Current Reagents view, when the OK button is selected, no printout will
be generated.
F6 New Entry
F6 New Entry can be selected to display the New Reagent Entry dialog box that
allows you to document new reagent replacement.
Refer to Subsection: Nonscheduled Maintenance Procedures, Reagent
Container Replacement for more details on its use.
9-12
Section 9
Reagent Log
The Reagent Log tab of the Reagents view is used by the operator to track the
history of reagent usage by the instrument.
The Reagent Log displays:
Rec #: reagent log record number.
Reagent: name of the reagent.
% Left: calculated percentage of reagent available in the current container.
Size: reagent container configuration volume.
List Number: reagent product number.
Exp Date: reagent expiration date. (YYYY/MM/DD)
Open Date: date the container was placed on the System.
OPID: operator ID when the new reagent entry was created.
Comment: operator entered comment remarks when the new reagent entry
was created.
NOTE: The comment field can be edited by either double-clicking on the record
or selecting F4 Edit to display the Edit Reagent Entry dialog box.
The Reagent Log can store up to 10,000 records. After 10,000 records have been
reached, the oldest record is deleted when a new record is added.
F1 Print
F1 Print can be selected to display the Print dialog box while in the Reagent
Log view.
Record range: (1) All (2) Selection and (3) Start Rec# End#.
Number of copies.
F3 Find/Filter
you to search and sort the information contained in the log.
Refer to Section 5: Operating Instructions, Table 5.15 for more details on its use.
F4 Edit
F4 Edit can be selected to display the Edit Reagent Entry dialog box for the
record selected and allows you to make changes to:
Expiration Date: reagent expiration date.
9-13

Section 9
Open Date: date the container was placed on the System

% Remaining: calculated percentage of reagent available in the current
container
Comment: operator entered comment remarks
NOTE: Edits or changes made using the Edit Reagent Entry dialog box
are not included in the System Event Type Edit/Change and
therefore are not saved to the System Event Log. It is important for
the operator to verify that the record selected or highlighted to edit
in the Edit Reagent Entry dialog box is the current reagent on the
System.
F6 New Entry
F6 New Entry can be selected to display the New Reagent Entry dialog box that
allows you to document reagent replacement.
Refer to Subsection: Nonscheduled Maintenance Procedures, Reagent
Container Replacement for more details on its use.
Users can delete reagent log(s) by selecting the log(s), and then using the right
mouse click to display a menu. The menu displays the following actions:
Save Records
Copy Selection
Copy All
Print
Print Preview
Delete Selection
Select Delete Selection. A confirmation dialog box displays, asking Delete
Selected Reagent Entry/s? Select Yes or No.
If you select Yes, a second confirmation dialog box displays, asking Confirm to
delete selected Active Reagent Entry/s? Select Yes or No. If you select Yes, the
selected reagent log(s) is deleted.
9-14
Section 9
Scheduled Maintenance Procedures

The following list of scheduled maintenance procedures are described in this
subsection:
6001 Auto-Clean
6002 Clean Loader Components
6005 Replace Transfer Pump Tubing
WARNING: Potential Biohazard. Wear lab coats, protective eyewear,
and gloves and follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR 1910.1030) or other equivalent
biosafety procedures.
6001 Auto-Clean
Perform this scheduled daily maintenance procedure to:
Clean the Shear Valve and associated fluidic system.
CAUTION: This activity presents a chemical-related hazard. Refer to
Section 8: Hazards, Subsection: Chemical Hazards.
The Auto-Clean Cycle is a fully automated cycle designed to clean the Shear
Valve, RBC/PLT Mixing Chamber, the WBC Mixing Chamber, the Optical Flow
Cell, the HGB Flow Cell, Open Mode Probe, the Closed Mode Needle, and all the
associated fluidics. The forward and reverse action of the peristaltic pump is used
during this cycle to gently scrub and remove any fibrin or debris within the system.
NOTE: The Auto-Clean cycle should be run prior to performing any maintenance
procedure. This ensures that all waste is purged from the fluid pathways.
Prerequisite
The Analyzer Status must be in the Ready State and in the Open Mode.
Maintenance view, Scheduled tab.
Estimated time required
15 Minutes
Tools/materials required
CELL-DYN Enzymatic Cleaner

Empty Tube
Replacement parts
NA
9-15

Section 9
Action
Steps
Reference
Preparation in 6001 - Auto-Clean

dialog box.
1. Select Auto-Clean task button.

2. Aliquot 2 mL Enzymatic
Cleaner into empty tube.
NOTE: Selecting the Cancel

button in this dialog box
will not log the task.
Aspirate Enzymatic Cleaner and

Begin Auto-Clean cycle
1. Hold the tube up until the tip of

the open probe touches the
bottom of the tube and select
the Start Auto-Clean button.
NOTE: Do not remove the tube
until you hear an audible
beep. Aspiration will take
90 seconds.
2. (Optional) Enter comments in
the <Enter Comment:> field.
NOTE: Comments are
automatically saved to the
Maintenance log view
when Auto-Clean cycle is
complete.
When Auto-Clean cycle is

complete, three background
counts are automatically run, logs
the activity to the Maintenance
Log and closes the 6001 - AutoClean dialog box.
Verify Background Results
1. Ensure background results are

within acceptable limits before
specimens.
See Section 4: Performance

Characteristics and Specifications, Subsection: Performance
Specifications.
6002 Clean Loader Components

Perform this scheduled weekly maintenance procedure to manually:
Clean the Sample Loader Tray
Clean the Sample Loader Racks
Clean the Tube Grippers
Clean the Tube Spinner
WARNING: Potential Biohazard. The loader track and racks may have
contacted potentially infectious materials. This is an activity or area where
you may be exposed to potentially infectious material. Refer to Section 8:
Hazards, Subsection: Biological Hazards.
CAUTION: This activity presents a chemical-related hazard. Refer to
Blood spills in the Sample Loader track or racks should be cleaned up immediately
to allow proper movement of the racks. Weekly cleaning is recommended when the
Sample Loader is used, but more frequent cleaning may be indicated by the
laboratory workload.
9-16
Section 9
Prerequisite
Replacement parts
Action
The Analyzer Status must be in the Ready State and in the Open or
Closed Mode. Maintenance view, Scheduled tab.
Lint-free pads or absorbent towel

Cotton swabs
Cleaning Solution (0.5% sodium hypochlorite)
DI Water
NA
Steps
Reference
Preparation in 6002 - Clean

Loader Components dialog box
1. Select Clean Loader

Components task button.
2. Select Disable Analyzer
button.
3. When Analyzer Status
indicates Maintenance State
remove the Processor Cover.

Disables Analyzer for cleaning.
Clean Sample Loader Tray
1. Wipe off Sample Loader tray

surfaces with cleaning solution.
NOTE: See Decontamination

Procedures for the
formula used to prepare
this solution.
Clean Sample Loader Racks
1. Wipe or rinse racks using

cleaning solution followed by
DI water rinse. Dry racks.
NOTE: Do not soak racks.

Soaking may impact rack
bar code label adhesion
and fade the bar code
imprint over time.
Clean Tube Grippers and Tube

Spinner - Procedure 1
1. With the Mixhead in the home

position, wipe out the gripper
surfaces using the DI water
and cotton swabs.
2. Wipe the tube spinner surfaces
using the cleaning solution and
cotton swabs.
3. Replace the processor cover.
4. Proceed to Action:
Maintenance Activity
Completion
NOTE: This procedure can be

used for routine cleaning.
If more extensive
cleaning of the Tube
Grippers is needed, follow
Procedure 2.
9-17

Section 9
Action
Steps
Clean Tube Grippers and Tube

Spinner - Procedure 2
NOTE: This procedure can be
used instead of
Procedure 1 if more
extensive cleaning of the
Tube Grippers is needed.
1. Loosen Mixhead thumbscrew

counter clockwise to unlock
and release the Mixhead Cam.
2. Lift and rotate the Mixhead 90
towards you.
3. Wipe out gripper surfaces
using the DI water and cotton
swabs.
4. Rotate the Mixhead 90 back
down to home position.
5. Prepare to lock the Mixhead
Cam by re-aligning it with the
thumbscrew.
6. Turn the thumbscrew
clockwise to lock the Mixhead
Cam in place.
NOTE: Verify that the Mixhead
cannot rotate towards
you. If it does, repeat
steps 5 6.
7. Wipe the tube spinner surfaces
using the cleaning solution and
cotton swabs.
8. Replace the Processor Cover.
Maintenance Activity Completion
1. Select Enable Analyzer

button.
3. Select Log Task Complete
button to indicate the task has
been performed.
9-18
Reference
Enables the Analyzer to Ready

State, logs the activity to the
Maintenance Log and closes the
6002 - Clean Loader
Components dialog box.
Section 9

Perform this scheduled monthly maintenance procedure to manually:
Inspect the four syringes.
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.
CAUTION: This activity presents a chemical-related hazard. See
Prerequisite
Closed Mode. Maintenance view, Scheduled tab.
NA
Replacement parts
NA
Action
Steps
Reference
Preparation in 6003 Inspect

Syringes dialog box.
1. Select Inspect Syringes task

button.
2. Open the Right Front Cover.

button in this dialog box will not log
the task.
Inspect Syringes
1. Visually inspect syringes.

NOTE: For any syringe requiring
cleaning or replacement,
complete this inspection
activity first and then
proceed to Maintenance
view, As-Needed tab and
select the Clean or
Replace Syringe task.
2. Close the Right Front Cover.

been performed.

6003 Inspect Syringes dialog
box.
9-19

Section 9
6005 Replace Transfer Pump Tubing

Replace the Transfer Pump Tubing
Constant pressure on the tubing under the Peristaltic Pump Wheel tends to flatten
the tubing, thereby inhibiting the flow of liquid past the pump. Use this procedure
to replace the Transfer Pump Tubing.
Prerequisite
Replacement parts
Lint-free pads or absorbent towel.
Transfer pump tubing set.
Action
Steps
Preparation in 6005
Replace
Transfer Pump
Tubing dialog box
1. Select Replace
Transfer Pump Tubing
task button.
2. Select Disable
Analyzer button.
3. Open the Left Front
Cover.
Remove Transfer
Peristaltic Pump
Tubing

indicates Maintenance
State, remove the tubing
completely out from
under the pump wheel
by holding the Pump
Shoe away from the
pump wheel and
removing the tubing
from under the wheel by
lifting the collars out of
the metal brackets.
2. Disconnect the tubing at
the plastic connectors
over a lint-free pad.
9-20
Reference
NOTE: Selecting the Cancel button in this dialog box
Disables Analyzer for tubing replacement.
1
2
3
4
5
Tubing
Collar
Pump Shoe
Pump Wheel
Pump Rollers
2
4
1
5
2
Section 9
Action
Replace Transfer
Peristaltic Pump
Tubing
Maintenance
Activity Completion
Reference
Steps
1. Connect the new tubing
to the plastic
connectors.
2. Place the collars on the
ends of the pump tubing
into the metal brackets.
3. Place the tubing under
the pump wheel by
holding the Pump Shoe
open, guiding the tubing
back under the pump
rollers.
NOTE: Ensure the tubing
is positioned in the
center of the
rollers.
4. Release the Pump Shoe
when the tubing is
centered under the
pump rollers.
5. Close the Left Front
Cover.
1. Select Enable
Analyzer button.
2. (Optional) Enter
comments in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.
1
2
3
4
5
Tubing
Collar
Pump Shoe
Pump Wheel
Pump
Rollers
2
4
1
5
2
Enables the Analyzer to Ready State, logs the activity to

the Maintenance Log and closes the 6005 Replace
Transfer Pump Tubing dialog box.
9-21

Section 9
Action
Verification
9-22
Steps
Reference
1. Select the Datalog

view.
2. Run at least three
background counts to
rinse the system.
3. Verify that the
background counts are
within acceptable limits
before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
Cover and verify the
component replaced is
not leaking.
Cover.
Section 9

Clean the Shear Valve
Cleaning of the Shear Valve ensures optimum performance. Any reagent or blood
residue may cause the valve to leak or function improperly.
NOTE: The center section is not connected by tubing and must be handled
carefully, as it will break if it is dropped. Care should be taken to avoid
chipping, scratching or otherwise damaging any of the sections. Do not
disconnect any of the tubing connected to the front and rear sections.
Prerequisite
Replacement parts
Action
Preparation in
6006 Clean
Shear Valve
window.
100 mL plastic container of DI Water
NA
Steps
Reference
1. Select the Clean Shear Valve

task button.
2. Select Clean Shear Valve
button.
3. Remove the Processor Cover.

Disables Analyzer and unlocks the shear

valve for cleaning.
9-23

Section 9
Action
Steps
Remove the
Shear Valve for
cleaning

indicates Maintenance State,
place a lint-free pad on the
shelf under the Shear Valve.
2. Turn the Shear Valve
Retaining Screw
counterclockwise until it can
be removed.
3. Pull the front section forward
until it is free of the mounting
arm and place on the lint-free
pad.
NOTE: Keep tubing attached.
4. Pull the ceramic center
section forward until it is free
of the mounting arm and place
into container of DI water for
the remainder of the cleaning
procedure.
CAUTION: Do not use
bleach. Use of Bleach will
damage the ceramic
center section.
5. Pull the rear section forward
until it is free from the
mounting arm and wipe the
inner surface using a lint-free
pad dampened with DI water.
Do Not Dry.
6. Wipe the mounting arm using
a lint-free pad dampened with
DI Water followed by a dry lintfree pad.
NOTE: Hold the rear section by
the edges to avoid
fingerprints on the inner
surface.
9-24
Reference
1 Back Section
2 Center
Section
3 Front Section
4 Retaining
Screw
5 Rim Notch
6 Lock Notch
7 Mounting Arm
1
2
5
6
Section 9
Action
Steps
Replace Shear
Valve
1. Align the lock notch of the rear

section with the mounting
guide and slide the section
back onto the mounting arm
as far as it will go.
NOTE: Be careful not to crimp
any of the attached
tubing.
2. Remove the ceramic center
section from the container of
DI Water and verify that it is
clean and free of lint and
fingerprints. Do Not Dry.
3. With the rim notch facing
down, align the lock notch of
the center section with the
mounting guide and gently
slide the section back flush
against the rear section on the
mounting arm.
CAUTION: Results
may be affected if the
center section is installed
backwards. Be certain the
rim notch faces down.
4. Wipe the inner surface of the
front section using a lint-free
pad dampened with DI water.
Do Not Dry.
5. Align the lock notch of the
front section with the
mounting guide and slide the
section back flush against
center section on the
mounting arm.
6. Hold the three sections
together and replace the
Shear Valve Retaining Screw,
turning the screw clockwise
until it stops.
7. Using a lint-free pad
dampened with DI Water,
wipe off the shelf below the
shear valve and remove any
pads that may have been left
on the instrument.
Reference
1 Back Section
2 Center
Section
3 Front Section
4 Retaining
Screw
5 Rim Notch
6 Lock Notch
7 Mounting Arm
1
2
5
6
9-25

Section 9
Action
Steps
Reference
Maintenance
Activity
Completion
1. Select Restore Shear Valve

button.
been performed.
Enables the Analyzer to Ready State, logs the activity

to the Maintenance Log and closes the 6006 Clean
Shear Valve dialog box.
Verification
1. Select the Datalog view.

2. Run at least five background
counts to rinse the system.
3. Verify that the background
counts are within acceptable
limits before running controls
unacceptable,
troubleshoot accordingly
(refer to Section 10:
Troubleshooting and
Diagnostics,
Subsection:
Troubleshooting Tips
and Techniques.)
4. Remove the Processor Cover
and verify that the component
cleaned is not leaking.
9-26
Section 9

Replace the Diluent/Sheath Filter
The Diluent/Sheath Filter is located on the left front flow panel to the left of waste
chamber #3. Replace the filter once a month, or whenever contamination is
suspected. A sign of contamination is usually manifested by high platelet
background, poorly defined PLT-RBC (0/10) scatterplot, excessive WBC
flagging, or erroneous 5-part differential results. Refer to Section 10:
Troubleshooting and Diagnostics, Subsection: Troubleshooting Tips and
Techniques for more details.
Prerequisite
Replacement parts
Diluent/Sheath Filter
Action
Preparation in 6007
Replace Dil/Sheath
Filter dialog box.
Steps
1. Select Replace Dil/
Sheath Filter task
button.
2. Select Close Filter
Valve button.
Cover.
Reference
NOTE: Selecting the Cancel button in this dialog
box will not log the task. Disables Analyzer
for Diluent/Sheath Filter replacement.
9-27

Section 9
Action
Steps
Remove Diluent/Sheath
Filter and replace with
new filter

State, locate the
Diluent/Sheath Filter on
the front left flow panel.
2. Disconnect the luer slip
inlet from the Diluent/
Sheath Filter over the
lint-free pad.
3. Connect the luer slip
inlet to the top of the
new Diluent/Sheath
Filter and remove the
old filter from its spring
clip.
4. Disconnect the silicon
tubing from the bottom
of the used Diluent/
Sheath Filter and
connect it to the bottom
of the new Diluent/
Sheath Filter.
5. Insert the new Diluent/
Sheath Filter into the
spring clip.
Cover.
Completion
1. Select Open Filter

Valve button.
2. (Optional) Enter
Comment:> field.
3. Select Log Task
Complete button to
been performed.
NOTE: Selecting the
Cancel button in
not log the task.
9-28
Reference
Enables the Analyzer to Ready State, logs the

activity to the Maintenance Log and closes the
6007 Replace Dil/Sheath Filter dialog box.
Section 9
Action
Verification
Steps
view.
2. Run at least five to ten
rinse the system.
3. Verify that the
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
Cover and verify that
the component replaced
is not leaking.
Cover.
Reference
9-29

Section 9

Perform this scheduled monthly maintenance procedure to:
Clean the Shear Valve and associated fluidic system.
CELL-DYN Ruby Systems running the Reticulocyte test should increase the
scheduled frequency from monthly to weekly.
NOTE: This activity takes approximately 2.5 hours to complete. During this time,
the instrument is not available to process specimens. The system is
automatically placed in Standby State when completed.
Extended Auto-Clean can be interrupted by selecting the Cancel button.
The system requests confirmation. If the request is confirmed, the system
continues the process to cancel the operation. The system logs the
cancellation in the event log. The system will go into Ready state within
approximately 20 minutes.
Prerequisite
Estimated time required
Replacement parts
Action
Preparation in 6008 Extended
Auto-Clean dialog box.
9-30
2.5 hours
CELL-DYN
Empty
Enzymatic Cleaner
Tube
NA
Steps
Reference
1. Select Extended Auto-Clean

task button.
2. Aliquot 2 mL Enzymatic
Cleaner into empty tube.

will prompt for
confirmation of request. If
the request is confirmed,
the system continues the
process to cancel the
operation. The system
logs the cancellation in
the event log.
Section 9
Aspirate Enzymatic Cleaner and

Begin Auto-Clean cycle.
1. Hold the tube up until the tip of

the open probe touches the
bottom of the tube and select
the Start Extended AutoClean button.
NOTE: Do not remove the tube
until you hear an audible
beep. Aspiration will take
90 seconds.
NOTE: Comments are
automatically saved to the
Maintenance log view
when Extended AutoClean cycle is complete.
When Auto-Clean cycle is

complete, the system goes into
Standby State.
NOTE: See Subsection: 7003
Prime for the procedure
to start the system from
the Standby State.
9-31

Section 9
As-Needed Maintenance Procedures

As-Needed maintenance procedures are performed to prevent or eliminate a
problem. These procedures can also be performed in the course of troubleshooting
(See Section 10: Troubleshooting and Diagnostics) or in response to direction
from your Country Service and Support Center.
The following As-Needed Maintenance Procedures are in this subsection:
6051 Clean Bar Code Reader Window
6052 Clean or Replace Open Mode Probe
6053 Clean or Replace Closed Mode Needle
6054 Clean or Replace Syringe
Bloodborne Pathogen Rule (29 CFR 1910.1030) or equivalent biosafety
procedures.
6051 Clean Bar Code Reader Window
Perform this as-needed maintenance procedure to manually:
Clean the Bar Code Reader Window
Prerequisite
Closed Mode. Maintenance view, As-Needed tab.
3
Replacement parts
9-32
- Applicator swabs (non-sterile)

lens tissue
Cleaning Solution: Isopropyl Alcohol, lens cleaner, or DI Water
Microscope
NA
Section 9
Action
Steps
Preparation in 6051 Clean Bar

Code Reader Window dialog box
1. Select Clean Bar Code

Reader Window task button.
button.
Clean Bar Code Reader Window

indicates Maintenance State,
wrap a lens tissue around each
swab.
2. Moisten one of the wrapped
swabs in cleaning solution.
3. Locate the Bar Code Reader
Window and wipe the window.
4. Using one of the dry wrapped
swabs, wipe the window dry.
NOTE: Use the second dry swab
if necessary.
Verification
1. Visually inspect the window to

ensure that blood, debris and
smudges have been removed.

button.
been performed.
Reference
Disables Analyzer for
cleaning.

6051 Clean Bar Code Reader
Window dialog box.
9-33

Section 9
6052 Clean or Replace Open Mode Probe

Remove and replace the Open Mode Probe
Prerequisite
Maintenance view, As-Needed tab.
Lint-free
Replacement parts
Action
pads or absorbent toweling

Allen wrench or Allen driver
Small needle-nose pliers or similar tool
3/32
See Appendix A: Parts and Accessories for list number.

Steps
Preparation in 6052
Clean or Replace Open
Mode Probe dialog box
1. Select Clean or Replace

Open Mode Probe task
button.
button.
Remove Open Mode Probe

State, remove the
Processor Cover and
locate the tubing attached
to the top of the Open
Mode Probe.
2. Place absorbent towel
under the Open Mode
Probe.
3. Hold the probe firmly and
use the pliers to carefully
work the tubing up and off
the top of the probe.
4. Using the Allen wrench,
remove the two hex nuts
holding the Probe Bracket
Arm to the Bracket
Support Arm on the Probe
Assembly Frame.
5. Pull the probe up and out
of the Wash Block.
9-34
Reference
NOTE: Selecting the Cancel button in this
dialog box will not log the task.
Disables Analyzer for Open Mode
Probe replacement.
1 Retainer
2 Probe
Bracket Arm
3 Bracket
Support Arm
4 Wash Block
Section 9
Action
Steps
Replace Open Mode Probe
1. Insert the new probe into

the Wash Block.
2. Place the Probe Bracket
Arm on top of the Bracket
Support Arm. Align the
holes in the bracket arm to
the holes in the Probe
Assembly Frame. Insert
and tighten the two hex
nuts using the Allen
wrench.
3. Hold the probe firmly and
reattach the Open Mode
tubing using pliers to
carefully work the tubing
back onto the top of the
probe.
NOTE: Wetting the top
portion of the probe
will allow the tubing
to slide more easily.
4. Verify that the Open Mode
tubing is firmly seated on
the probe, remove the
absorbent towel, and
replace the Processor
Cover.
Completion

button.
2. (Optional) Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has been
performed.
button in this dialog
box will not log the
task.
Reference
1 Retainer
2 Probe
Bracket Arm
3 Bracket
Support Arm
4 Wash Block

activity to the Maintenance Log and closes
the 6052 Clean or Replace Open Mode
Probe dialog box.
9-35

Section 9
Action
Verification
9-36
Steps
Reference

rinse the system.
3. Verify that the background
counts are within
acceptable limits before
specimens.
unacceptable,
troubleshoot
accordingly (refer to
Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Remove the Processor
Cover and verify that the
component cleaned or
replaced is not leaking.
5. Replace the Processor
Cover.
Section 9

Clean or replace the Closed Mode Needle
WARNING: Potential Biohazard. The closed mode vent needle is sharp
and potentially contaminated with infectious materials. Exercise caution
when handling the needle and performing this procedure. See
Section 8: Hazards, Subsection: Biological Hazards.
If the Closed Mode Needle becomes bent or becomes clogged (and performing the
special protocol Flush Closed Needle does not remove the blockage), the needle
should be replaced.
NOTE: The needle consists of two separate needles joined together, one for
venting and one for aspiration.
Prerequisite
Replacement parts

needle-nose pliers or similar tool
Steps
Reference
1. Select Clean or Replace

Closed Mode Needle
task button.
button.
Cover.
NOTE: Selecting the Cancel button in this dialog

box will not log the task. Disables
Analyzer for Closed Mode Needle
replacement.
Small
See Appendix A: Parts and Accessories for list number.
Action
Preparation in 6053
Clean or Replace
Closed Mode Needle
dialog box
Lint-free
9-37

Section 9
Action
Remove Closed Mode
Needle
9-38
Steps
State, locate the Closed
Mode Needle.
NOTE: The vent needle is
the shorter side of
the closed mode
needle and faces
the instrument. The
tubing attached to
the opening at the
top of the vent
needle leads to a
vent chamber,
while the tubing
attached to the
opening at the top
of the aspiration
needle leads to the
Y valve located
between the Shear
Valve and the Open
Mode Probe.
2. Hold the needle firmly
and use the pliers to
carefully work the tubing
up and off both ends of
the needle.
3. Loosen the Thumb
Screw at the top of the
Needle Mounting
Assembly and remove
the clip holding the
needle to the assembly.
4. Carefully pull the top of
the needle forward until
the flange clears the slot
in the bracket. Lift the
needle up and out of the
Wash Block.
Reference
1 Holding Clip
2 Aspiration
Tubing
3 Vent Tubing
4 Needle Top
5 Vent Needle
(shorter)
6 Aspiration
Needle
(longer)
7 Wash Block
8 Needle
Mounting
Assembly
9 Thumb Screw
(with spring)
2
3
6
7
Section 9
Action
Replace Closed Mode
Needle
Completion
Steps
1. Place the new needle
into the Wash Block,
making sure the vent
needle (shorter side)
faces the instrument,
and place the flange into
its slot in the top bracket.
2. Reinstall the clip over the
top of the needle and
tighten the Thumb
Screw.
3. Hold the needle firmly
and attach the vent
tubing to the vent side
and the aspiration tubing
to the aspiration side.
portion of the probe
will allow the tubing
to slide more easily.
4. Verify that the tubing is
attached correctly and
replace the Processor
Cover.
button.
2. (Optional) Enter
Comment:> field.
3. Select Log Task
Complete button to
been performed.
NOTE: Selecting the
Cancel button in
not log the task.
Reference
1 Holding Clip
2 Aspiration
Tubing
3 Vent Tubing
4 Needle Top
5 Vent Needle
(shorter)
6 Aspiration
Needle
(longer)
7 Wash Block
8 Needle
Mounting
Assembly
9 Thumb Screw
(with spring)
2
3
6
7

activity to the Maintenance Log and closes the
dialog box.
9-39

Section 9
Action
Verification
9-40
Steps
Reference

rinse the system.
3. Verify that the
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
Cover and verify that the
component cleaned or
replaced is not leaking.
Cover.
Section 9
6054 Clean or Replace Syringe

Perform this as-needed maintenance procedure to manually clean, remove, and/or
replace the:
Sample Injection Syringe
HGB Lyse Syringe
WBC Lyse Syringe
Diluent/Sheath Syringe
CAUTION: This activity presents a chemical-related hazard. Section 8:
Hazards, Subsection: Chemical Hazards.
Syringes on the CELL-DYN Ruby System should be cleaned only as necessary one
at a time to ensure that each syringe is replaced in the correct position. Replace
each syringe after it is cleaned and then remove the next one to be cleaned.
NOTE: Only remove and replace one syringe at a time.
Prerequisite
Lint-free
Replacement parts

500mL container
DI Water
Small container of each reagent to refill the clean syringe(s)
Allen wrench (7/64") or Allen driver
Sample Injection Syringe
HGB Lyse and WBC Lyse Syringe
Action
Steps
Reference
Preparation in 6054
Clean or Replace
Syringe dialog box
1. Select Clean or
Replace Syringe task
button.
2. Select Disable
Analyzer button.
3. Open the Right Front
Cover, lift and remove
the Right Front Railing.

will not log the task. Disables Analyzer for
Syringe replacement.
9-41

Section 9
Action
Remove and Clean
Syringe:
Diluent/Sheath
Syringe
9-42
Steps
State, locate the
on the front right flow
panel and note that the
plastic barrel of this
syringe has four
vertical edges, two of
which fit into vertical
grooves on the syringe
mounting bracket, and
a horizontal circular
plastic flange which
also fits into a
horizontal groove on
the syringe mounting
bracket.
2. Grasp the syringe
barrel below the Luer
Lock with one hand.
With the other hand,
grasp the syringe
plunger below the
metal band. Gently and
carefully, pull and twist
one side of the syringe
to release it from the
snap-in mounting
bracket.
3. Carefully turn the Luer
Lock on the syringe
clockwise to release
the fitting, using an
absorbent towel to
catch any excess
reagent.
4. Note the liquid level of
reagent in the syringe
so that it can be refilled
after cleaning to the
same approximate
level.
Reference
1
2
3
4
Tube Fitting
Luer Lock
Holding Block
Diluent/Sheath
Syringe
5 Double Collar
1
2
3
4
Section 9
Steps
Action
(Continued from
previous page)
5. Slowly dispense the
reagent into
appropriate waste
container or sink.
NOTE: Do not pull the
plunger out of the
barrel. Do not
push or pull on
the plunger when
the syringe is dry,
as it may damage
the plunger.
6. Immerse the tip of the
syringe in the container
of DI Water and
aspirate the water into
the syringe until it is
full. Dispense the water
into appropriate waste
container or sink.
Repeat this step 5
times.
7. Refill the syringe with
Diluent/Sheath reagent
to the level noted in
Step 4.
Reference
WARNING: Point the tip of the syringe away

from eyes.
9-43

Section 9
Action
Replace Syringe:
Diluent/Sheath
Syringe
9-44
Steps
1. Place the fitting back
into the Luer Lock on
the top of the syringe
and turn the lock
counterclockwise until
the fitting is finger tight.
2. Insert the double collar
on the plunger into the
syringe drive fork and
line up the horizontal
circular flange on the
barrel with the slot on
bracket.
3. Insert one of the
vertical edges on the
barrel into a vertical
side groove on the
syringe mounting
bracket and carefully
twist the barrel until the
other side snaps into
place.
4. Verify that the syringe
is firmly in place.
Reference
1
2
3
4
Tube Fitting
Luer Lock
Holding Block
Diluent/Sheath
Syringe
5 Double Collar
1
2
3
4
Section 9
Action
Steps
Remove and Clean

Syringe:
Sample Injection
Syringe, or HGB Lyse
Syringe, or WBC Lyse
Syringe
1. Verify Analyzer Status

State, locate the
Sample Injection
Syringe on the front
right flow panel.
NOTE: Only remove and
replace one
syringe at a time.
2. Place one finger
behind the upper
portion of the barrel
and one finger behind
the lower portion of the
plunger. Gently pull
forward until the
syringe barrel snaps
free from the syringe
mounting bracket and
the double collar
attached to the bottom
of the plunger clears
the syringe drive fork
on the syringe drive
assembly.
NOTE: The flattened
edges of the glass
flange at the
bottom of the
syringe barrel
align with the
bottom edge of
the syringe
mounting bracket.
3. Using one hand to
grasp the fitting at the
top of the syringe and
an absorbent towel to
catch any excess
reagent, carefully turn
the syringe
counterclockwise to
release it from the
fitting.
Reference
These three syringes snap into their mounting
brackets.
1 Sample Injection
Syringe
2 HGB Lyse Syringe
3 WBC Lyse Syringe
4 Diluent/Sheath
Syringe
5 Mounting Brackets
1 2 3 4
1 Flattened Edge
2 Tube Fitting
3 Sample Injection
Syringe
4 Double Collar
5 Base
2
3
4
1
5
9-45

Section 9
Action
Steps
(Continued from
previous page)
4. Note the liquid level of
reagent in the syringe
so that it can be refilled
after cleaning to the
same approximate
level.
5. Slowly dispense the
reagent into
appropriate waste
container or sink.
NOTE: Do not pull the
plunger out of the
barrel. Do not
push or pull on
the plunger when
the syringe is dry,
as it may damage
the plunger.
6. If replacing the syringe
with a new syringe,
remove the collar from
the old syringe using a
7/64" allen wrench and
attach to the new
syringe plunger,
tightening with the
7/64" allen wrench.
7. Immerse the tip of the
syringe in the container
of DI Water and
aspirate the water into
the syringe until it is
full. Dispense the water
into appropriate waste
container or sink.
Repeat this step 5
times.
8. Refill the syringe with
appropriate reagent to
the level noted in
Step 4.
NOTE: Sample Injection
Syringe is filled
with Diluent/
Sheath reagent.
9-46
Reference
WARNING: Point tip away from eyes.
Section 9
Action
Steps
Replace Syringe:
Sample Injection
Syringe
1. Place the fitting into the

top of the syringe and
turn the syringe
clockwise until the
fitting is finger tight.
2. Insert the double collar
on the plunger into the
syringe drive fork and
line up the flattened
edges of the glass
flange at the bottom of
the syringe barrel with
the bottom edge of the
syringe mounting
bracket.
3. Snap the syringe into
bracket.
4. Verify that the syringe
is vertical and firmly in
place.
5. Replace the Right
Front Railing and close
the Right Front Cover.
Completion
1. Select Enable
Analyzer button.
2. (Optional) Enter
comments (e.g.
indicate each syringe)
in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
been performed.
NOTE: Selecting the
Cancel button in
not log the task.
Reference
1 Sample Injection
Syringe
2 HGB Lyse Syringe
3 WBC Lyse Syringe
4 Diluent/Sheath
Syringe
5 Mounting Brackets
1 2 3 4

to the Maintenance Log and closes the 6054 Clean
or Replace Syringe dialog box.
9-47

Section 9
Action
Verification
9-48
Steps
Reference

view.
rinse the system.
3. Verify that the
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Open the Right Front
Cover and visually
inspect that the
syringes are not
leaking.
5. Close the Right Front
Cover.
Section 9

Clean the Fan Filters on side panels.
The air filters are located on the side panels of the Analyzer. The filters require
periodic removal and cleaning to maintain a constant, unrestricted air flow.
NOTE: More frequent cleaning may be required whenever the instrument is
located in a particularly dusty or warm area.
The Analyzer Status can be in the Standby or Ready State and in either
the Open or Closed Mode. Maintenance view, As-Needed tab.
Prerequisite
Replacement parts
Action
Lint-free pads or absorbent toweling

Running Water
Fan Filter
Steps
Reference
Preparation in 6055
Clean Fan Filter
dialog box.
1. Select Clean Fan

Filter task button.
2. Select Disable
Analyzer button.
NOTE: Selecting the Cancel button in this dialog box will

not log the task. Disables Analyzer for cleaning.
Remove Fan Filter

Frame and Clean
Fan Filter
1. When Analyzer
Status indicates
Maintenance State,
snap off the plastic
Fan Filter Frame
from the left or right
side panel.
2. Remove the Fan
Filter from the Fan
Filter Frame and
rinse under running
water.
3. Blot the Fan Filter
dry.
4. Reinsert the Fan
Filter into the Fan
Filter Frame and
snap the frame back
in place on the side
panel.
(Optional) The Fan Filter may be cleaned using a vacuum

cleaner once it is removed from the fan filter frame.
1 Intake Fan - Right

side
1 Intake Fan - Left

side
9-49

Section 9
Action
Steps
Reference
Maintenance
Activity Completion
1. Select Enable
Analyzer button.
2. (Optional) Enter
comments in the
<Enter Comment:>
field.
3. Select Log Task
Complete button to
been performed.
NOTE: Selecting the
Cancel button
in this dialog
box will not log
the task.
Enables the Analyzer to Ready State, logs the activity to

the Maintenance Log and closes the 6055 Clean Fan
Filter dialog box.
9-50
Section 9
Special Protocols
The following Special Protocol procedures are in this subsection:
7000 To Standby
7002 Disable/Enable Analyzer
7003 Prime
7004 Empty/Fill Optical Flow Cell
7007 Empty/Fill Reagent Reservoir
7000 To Standby
This automated special protocol is available for the operator to place the Analyzer
in the Standby State prior to executing System Shutdown that powers off the
system.
NOTE: When the instrument has been idle for four hours, it will automatically
enter the Standby State.
NOTE: The Analyzer goes from STANDBY to READY state in 7 to 13 minutes.
This protocol rinses and drains fluidics, reduces laser power, and opens pinch
valves. The solenoid valves are automatically opened periodically to prevent the
tubing from becoming pinched if the Analyzer is left in this state. When the
protocol is complete, the operator may proceed to System Shutdown special
protocol to power off the System.
Action
Steps
Place Analyzer in
Standby State
1. Select Maintenance view.

2. Select Special Protocols tab.
3. Select To Standby task button to open
the To Standby dialog box.
4. (Optional) Enter comments in the
<Enter Comment:> field.
5. Select To Standby button.
Reference
NOTE: Selecting the Cancel button in
this dialog box will not log the
task.
Enables the Analyzer to Standby State,
logs the activity to the Event Log and
closes the 7000 To Standby dialog box.
9-51

Section 9
Action
Steps
Bring the Analyzer

out of Standby
State
1. Select F12 Prime.

3. Verify that the background results are
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)
Reference
Enables the Analyzer to Ready State.

This automated special protocol is utilized to bring the Analyzer from an
Uninitialized State to an Initialized State during certain maintenance tasks and
corrective action for various Analyzer fault conditions.
The execution of this special protocol establishes communication between the
Analyzer and Data Module. When initialization is complete, the Analyzer can then
be primed.
Action
Initialize the
Analyzer to the
Ready State
9-52
Steps
3. Select Initialize Analyzer task button to
open the Initialize Analyzer dialog box.
4. (Optional) Enter comments in the <Enter
Comment:> field.
5. Select Initialize Analyzer button.
Section 10: Troubleshooting and
Diagnostics, Subsection:
Techniques.)
Reference
task.
Enables the Analyzer to Initialized State,

closes the 7001 Initialize Analyzer
dialog box.
Section 9
Action
(Optional)
Prime the
Analyzer to the
Ready State
using the
function key
Steps
Reference

Section 10: Troubleshooting and
Diagnostics, Subsection:
Techniques.)
7002 Disable/Enable Analyzer

This automated special protocol is utilized to prevent the Analyzer from cycling
while nonscheduled maintenance procedures are performed.
Action
Disable Analyzer
Enable Analyzer
Steps
Reference
task.

3. Select Disable/Enable Analyzer task
button to open the Disable/Enable
Analyzer dialog box.
4. Select Disable Analyzer button.
Places Analyzer in Maintenance State

for maintenance task.
1. Select Enable Analyzer button.

2. Enter comments (e.g. Flushed Open
Probe) in the <Enter Comment:> field.
3. Select Log Task Complete button to
indicate the task has been performed.
Enables the Analyzer to the current state,

closes the 7002 Disable/Enable
9-53

Section 9
7003 Prime
This automated special protocol is available for the operator to activate a System
prime, execute an auto background, and place the Analyzer in Ready State during
Analyzer power on, certain maintenance tasks, and corrective action for various
Analyzer fault conditions.
NOTE: During Analyzer power on, this same activity can be activated by
selecting the F12 Prime button.
Action
Prime the
Analyzer
(Optional) Prime
the Analyzer using
the function key
9-54
Steps
3. Select Prime button to open the Prime
dialog box.
5. Select Prime button.
Techniques.)
Techniques.)
Reference
task.
Enables the Analyzer to Ready State,

closes the 7003 Prime dialog box.
NOTE: The F12 Prime function key will

only display when available.
Section 9
7004 Empty/Fill Optical Flow Cell

This automated special protocol is available for the operator to activate during
NOTE: The System must be in the Open Mode to execute this activity.
Action
Steps
Preparation
Analyzer Status must be in Open Mode.
Empty Optical
Flow Cell

3. Select Empty/Fill Optical Flow Cell
task button to open the Empty/Fill
Optical Flow Cell dialog box.
4. Select Empty Flow Cell button.
Fill Optical Flow

Cell
1. Select Fill Flow Cell button.

2. Enter comments (e.g. Empty/Fill Flow
Cell") in the <Enter Comment:> field.
4. Run a whole blood before QC or Patient
testing.
Reference

task.
Analyzer Status indicates Maintenance
State.
Enables the Analyzer to current state,

closes the 7004 Empty/Fill Optical
Flow Cell dialog box.
9-55

Section 9

This automated special protocol is utilized to effectively power off the data module
and instrument and is also executed during certain maintenance tasks and
NOTE: System Shutdown cannot be performed during the autobackup of
database.
NOTE: Selecting File, then Shutdown from the menu bar can also access this
same activity.
Action
Steps
System Shutdown

3. Select System Shutdown button to
open the System Shutdown dialog
box.
5. Select System Shutdown button.
NOTE: The application and operating
system software will shutdown, the
display will turn to black, and
instrument power will turn off.
System Shutdown
using the menu
bar.
9-56
1. Select File from the menu bar.

2. Select Shutdown
NOTE: The application and operating
system software will shutdown, the
display will turn to black, and
instrument power will turn off.
Reference
task.
Opens dialog box to OK or Cancel

initiation of shutdown.
Logs the activity to the Event Log and

closes the 7005 System Shutdown
dialog box.
Opens dialog box to OK or Cancel

initiation of shutdown.
Section 9

This automated special protocol is available for the operator to activate and drain
the internal vacuum accumulators during corrective action for various Analyzer
fault conditions and place the Analyzer in an Uninitialized State.
NOTE: If the fault condition corrective action requests this protocol to be
executed multiple times, the Drain Accumulator task button can be
selected when the Analyzer Status indicates Initialized.
Action
Steps
Drain Accumulator

3. Select Drain Accumulator task button
to open the Drain Accumulator dialog
box.
5. Select Drain Accumulator button.
Bring Analyzer to
Ready State using
the function key
1. (Optional) Repeat action Drain

Accumulator.
Techniques.)
Reference
task.
Analyzer Status indicates Uninitialized

State, logs the activity to the Event Log
and closes the 7006 Drain
Accumulator dialog box.
NOTE: The system will automatically
initialize.
9-57

Section 9
7007 Empty/Fill Reagent Reservoir

This automated special protocol is available for the operator to activate the draining
and filling of either the WBC Lyse reservoir, HGB Lyse line tubing, or the Diluent/
Sheath reservoirs during corrective action for various Analyzer fault conditions,
and place the Analyzer in the Ready State.
NOTE 1: This protocol must be repeated three times in order to empty and fill the
WBC Lyse reservoir, HGB Lyse line tubing, and the Diluent/Sheath
reservoirs.
NOTE 2: The analyzer must be in the READY state and in the Open Mode.
Action
Empty Reagent
Reservoir/Line
Fill Reagent
Reservoir/Line
9-58
Steps
1. Remove reagent lines from reagent
containers.
4. Select Empty/Fill Reagent Reservoir
task button to open the Empty/Fill
Reagent Reservoir dialog box.
5. Select either:
Empty WBC Lyse button
Empty HGB Lyse button
Empty Dil/Sheath button
1. Place reagent line back to reagent box
or to new reagent container.
2. Depending on which button was
selected to empty, select Fill <WBC
Lyse, HGB Lyse, or Dil/Sheath>
button.
testing.
Reference
task.
Analyzer Status indicates Maintenance

State.

closes the 7007 Empty/Fill Reagent
Reservoir dialog box.
Section 9

This automated special protocol is available for the operator to activate when a
blockage is suspected.
NOTE: The System must be in the Closed Mode to execute this activity.
Action
Steps
Preparation
Analyzer Status must be in Ready State,

Closed Mode.
Flush Closed
Needle

3. Select Flush Closed Needle task
button to open the Flush Closed
Needle dialog box.
5. Select Flush Closed Needle button.
testing.
Reference

this dialog box will not log the task.

closes the 7008 Flush Closed Needle
dialog box.
9-59

Section 9

This automated special protocol is available to the operator for preparing the
Analyzer for shipment, prolonged periods of non-use including power off, or if
instrument contamination is suspected.
WARNING: Potential Biohazard. Consider all materials that have
contacted human sourced material as potentially infectious.
NOTE: The complete activity requires this automated protocol to be executed

three times: first using 0.5% sodium hypocholorite, second using DI
water, and third using air. The first and second time, this cycle drains and
rinses the fluidics system, releases vacuum and pressure, and places
Analyzer in Uninitialized State. When the cycle is finished the third time,
the Data Module and Analyzer will power off. It is important to review
the entire procedure before executing this special protocol.
NOTE: When starting the system after 2 weeks or more of inactivity, or if
instrument contamination is suspected, it is necessary to perform 6007
Replace Dil/Sheath Filter before priming the System.
Action
Preparation
9-60
Steps
3 Large beakers or
containers.
Cleaning solution
(0.5% sodium
hypochlorite) 600 mL.
DI water 300 mL.
200 mL of nonabrasive
detergent solution.
Four Plastic Bags.
Shear valve dummy
center section.
Reference
NOTE: See Decontamination Procedures for the formula
used to prepare this solution.
Section 9
Action
Prepare for
Shipping with
0.5% sodium
hypochlorite
Prepare for
Shipping with
DI water
Steps
Reference
1. Remove the WBC

Lyse, HGB Lyse, and
Diluent/Sheath reagent
lines from their reagent
containers and place
the lines in the
container with 300 mL
of cleaning solution.
2. Select Maintenance
view.
3. Select Special
Protocols tab.
4. Select Prepare for
Shipping task button
to open the Prepare
for Shipping dialog
box.
5. Select Prepare For
Shipping button.
6. Continue with next
action.
NOTE: Selecting the Cancel button in this dialog box will not
log the task.
1. When the Analyzer

Status indicates
Initialized State, place
the lines in the
container with 300 mL
of DI water.
view.
3. Select Special
Protocols tab.
to open the Prepare
for Shipping dialog
box.
Shipping button.
6. Continue with next
action.
Analyzer Status indicates Maintenance State.
9-61

Section 9
Action
Steps
Prepare for
Shipping with
Air and Power
Off
1. When the Analyzer

Status indicates
Initialized State, place
the lines in a clean
empty container.
view.
3. Select Special
Protocols tab.
to open the Prepare
for Shipping dialog
box.
Shipping And Power
Off button.
NOTE: At the end of this
cycle, the
application and
operating system
software will
shutdown, the
display will turn to
black, and
instrument power
will turn off.
6. If this special protocol
is being executed for
preparing for shipment
or prolonged periods of
non-use, skip this step
and proceed to the
next action.
7. If this special protocol
is being executed
because of suspected
contamination, install
new reagent line tubing
and place into new
reagent containers,
install a new dil/sheath
filter, and then proceed
to power ON the data
station. STOP here, do
not continue to next
action.
9-62
Reference
Section 9
Action
Steps
Remove
Tubing From
Rear Panel
1. Turn the Main power

switch to OFF on the
Rear Panel.
2. Remove all reagent
lines, Waste Tubing
line, and the Waste
Sensor line from the
Rear Panel.
3. Empty the Waste
Tubing line and rinse
with disinfectant.
4. Place each length of
tubing in a separate
plastic bag and close
the bag. (Keep the
Waste line and Waste
Sensor line together.)
5. Place in Accessory Kit.
Remove
Power Cord
1. Remove the Analyzer

power cord from the
outlet receptacle and
remove its connector
on the rear of the
Analyzer.
2. Place in Accessory Kit.
Disconnect
Data Module
Cable
Connections
1. Disconnect all the

cable connections on
the rear of the Data
Module.
2. Place the HSSL cable
in the Accessory Kit.
Wipe down of
instrument
exterior.
1. Wipe down instrument

surfaces with nonabrasive detergent
solution.
2. Then, wipe down
instrument with 0.5%
sodium hypochlorite
solution.
3. Then, wipe down
instrument with tap
water.
Reference
9-63

Section 9
Action
Steps
Remove
Tubing from
NC Valves and
Transfer Pump
1. Open the Left and

Right Front Covers and
locate the six Normally
Closed Valves.
2. Carefully remove the
tubing from all the NC
Valves.
NOTE: Do not detach the
tubing.
3. Carefully remove the
tubing from the
Transfer Pump.
NOTE: Do not detach the
tubing.
4. Close the Left and
Right Front Covers.
Prepare Shear
Valve
9-64

Cover.
2. Remove and perform
6006 Clean Shear
Valve.
3. Blot ceramics dry.
Wrap the ceramic
center section carefully
for protection and
place in the Accessory
kit.
4. Obtain the Shear Valve
Dummy Center section
from the Accessory Kit
and reassemble the
Shear Valve on the
instrument using the
dummy center section.
Cover.
Reference
Transfer Pump
1 Back Section
2 Center
Section
3 Front Section
4 Retaining
Screw
5 Rim Notch
6 Lock Notch
7 Mounting Arm
1
2
5
6
Section 9
Nonscheduled Maintenance Procedures

The following list of nonscheduled maintenance procedures described in this
subsection are tasks that the operator may perform that are not based on time,
cycles, or scheduled intervals managed by the System software.
Printer Cleaning
Reagent Container Replacement
Replace Tubing in Normally Closed (NC) Valves
Vacuum Accumulator 1 and 2 Rinsing Procedure
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) requires
decontamination of laboratory equipment prior to servicing or shipment:
Flush the instrument by performing the 6001 Auto-Clean cycle. This cycle
flushes all of the fluid pathways with reagents to purge any waste from the fluid
pathways. The Open Mode Probe and the Closed Needle are automatically
rinsed after every cycle. The surfaces of the instrument should be wiped with a
nonabrasive detergent solution to remove any soiling, then wiped with a
tuberculocidal disinfectant, such as a 0.5% sodium hypochlorite solution.
If the instrument is to be shipped, it must be decontaminated prior to
shipment by performing the 7009 Prepare for Shipping special protocol.
To calculate the percent (%) sodium hypochlorite concentration desired see the
following formula:
A = Percent (%) of sodium hypochlorite solution desired
B = Percent (%) of sodium hypochlorite stock solution (as purchased)
X = Parts of water to be mixed with one part of the sodium hypochlorite stock solution
X=
B-A
A
Example:
If you need a 0.5% solution of sodium hypochlorite for a cleaning procedure, and
the label on the bottle of bleach states that it is 5.25% sodium hypochlorite, then:
X=
5.25 -.5
.5
X = 9.5
9-65

Section 9
Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium
hypochlorite solution, or 9.5 mL of deionized water to 1.0 mL of bleach (5.25%
sodium hypochlorite) to obtain 10.5 mL of a 0.5% solution of sodium hypochlorite.
Printer Cleaning
Printers must be turned off before cleaning. Do not dust inside the printer with
paper towels or tissues. Do not use solvents or strong detergents on the cabinets.
Printers should be cleaned as necessary to maintain good operating condition (at
least every six months or approximately every 300 hours of operation). For more
detailed maintenance instructions, refer to the printer manufacturers manual.

The CELL-DYN Ruby System utilizes liquid level sensing hardware to detect
when a reagent container is empty and requires replacement, as indicated by a
WBC Lyse Empty, HGB Lyse Empty, or Dil/Sheath Empty System Initiated
Message. See also Section 10: Troubleshooting and Diagnostics;
Subsection: List of System Messages.
The operator must first install a new container of reagent before selecting the Clear
Fault button in the SIM dialog box. A New Reagent Entry dialog box will open
that allows the operator to select which reagent is being replaced and record the
following:
Lot Number
Expiration Date
Open Date
% Remaining
Comment
It is recommended to run at least five background counts to rinse the system and
verify that the background counts are within acceptable limits before running
NOTE: If the counts are unacceptable, troubleshoot accordingly (refer to
Section 10: Troubleshooting and Diagnostics, Subsection:
Troubleshooting Tips and Techniques.)
CAUTION: Do not pour the remaining contents of the old reagent
container into the new reagent container. This mixing could contaminate the
new reagent.
NOTE: The operator must enter the correct % Remaining or incorrect reagent
warning messages may occur.
9-66
Section 9
NOTE: If replacing a reagent on the System before a reagent empty message is

generated, after installing the new reagent select Maintenance View,
Special Protocols, Prime, to move the new reagent into the system.
Reagent contamination could be suspected if a group of parameters measured using
the same reagent are consistently errant. If reagent replacement is required as a
result of data-related troubleshooting, select F6 - New Entry in the Reagents view
to open the New Reagent Entry dialog box. Select which reagent is being replaced
and complete the remaining dialog fields. Run at least five background counts to
rinse the system and verify that the background counts are within acceptable limits
before running controls or patient specimens.
NOTE: If the counts are unacceptable, troubleshoot accordingly (refer to
Section 10: Troubleshooting and Diagnostics, Subsection:
Troubleshooting Tips and Techniques.)
Replace Tubing in Normally Closed (NC) Valves

Perform this nonscheduled maintenance procedure to manually:
Replace tubing in Normally Closed Valves.
This activity presents a chemical-related hazard. See Section 8: Hazards,
Subsection: Chemical Hazards.
Tubing in the Normally Closed Valves should be replaced when it shows signs of
indentation or flattening and is impeding the flow of fluid through the tubing.
The Analyzer must be Shutdown. Status must be in the Ready State and
in the Open Mode. Maintenance view, Special Protocols tab.
Prerequisite
Replacement parts
Valve
Tubing (12)
Hemostats (2)
NA
Action
Steps
Reference
Preparation in
7005
System
Shutdown
dialog box.
1. Select System
Shutdown task button.
2. Select System
Shutdown button, the
select OK.
NOTE: Selecting the Cancel button in this dialog box will not
log the task. Prepares the Data Module for shutdown
and powers off the System.
9-67

Section 9
Action
Replace
Tubing in
Normally
Closed (NC)
Valves
9-68
Steps
1. When display is black,
remove the Processor
Cover, open the Left
and Right Front Covers
and locate all six NC
valves.
2. Use hemostats to
clamp the tubing above
and below the normally
closed valve tubing
connectors to prevent
leakage when the
normally closed valve
tubing is replaced.
NOTE: Remove and
replace NC valve
tubing one valve
at a time.
3. Pull the tubing from the
connectors on either
side and then insert the
new tubing into both
connectors making
sure the tubing is
pushed all the way into
the connectors.
4. Reinsert the tubing into
the slot on the valve,
working the tubing
back and forth until it is
completely inserted
into the valve and
resting on the bottom
of the slot.
5. Remove the
hemostats.
6. When all valve tubing
has been replaced,
close the Left and
Right Front Covers,
and replace the
Processor Cover.
Reference
1
2
3
4
Tubing
Slot
Valve
Connectors
3
1
Section 9
Action
Power ON
Steps
1. Press and hold the
Data Station power
button for 4 seconds to
restart the System.
indicates Initialized
State, select F12
Prime.
Reference
1 CD-ROM or DVD
Drive
2 Floppy Drive
3 Data Station
Power Button
4 Main Power
Switch (Rear
Panel)
5 Intake Fan
2
1
3
4

Log
Maintenance
Activity
Completion
1. Select System view,

Event Log tab.
2. Using the mouse,
highlight and doubleclick on the record #
associated with the
System Shutdown
event. Enter text (e.g.
Replaced NC
tubings.) in the
<Comment:> field and
select the OK button.
Opens the Event Properties dialog box.
Logs the comment to the Event Log record and closes the
Event Properties dialog box.
9-69

Section 9
Action
Verification
9-70
Steps
Reference

view.
rinse the system.
3. Verify that the
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and
Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
Cover, open the Left
and Right Front Covers
and verify the
components are not
leaking.
Cover and close the
Left and Right Front
Covers.
Section 9

Flush the interior of the Open Mode Probe
The Open Sample Aspiration Probe is thoroughly cleaned whenever the AutoClean cycle is performed. The probe may be cleaned manually using this procedure
if a blockage is suspected.
Maintenance view, Special Protocols tab.
Prerequisite
Lint-free

(10 cc or larger) with at least 3 of 1/32 (internal diameter)
silicone tubing attached to the tip
Small needle-nose pliers or similar tool
Small beaker or container
DI Water
Cleaning solution (0.5% sodium hypochlorite)
Syringe
Replacement parts
NA
Action
Steps
Reference
Preparation in 7002
Disable/Enable
Analyzer dialog
box.
1. Select Disable/Enable
Analyzer task button.
2. Select Disable
Analyzer button.
3. Fill the syringe with
Cleaning Solution.

will not log the task. Disables Analyzer for
cleaning.
NOTE: See Decontamination Procedures for the

formula used to prepare this solution.
9-71

Section 9
Action
Flush Open Mode
Probe
Steps
State remove the
Processor Cover and
locate the tubing
attached to the top of
the Open Mode Probe.
2. Place small beaker
under the probe to
catch the rinse liquid.
3. Hold the probe firmly
and use the pliers to
carefully work the
tubing up and off the top
of the probe.
4. Attach the tubing
connected to the
syringe with Cleaning
Solution onto the top of
the probe and gently
inject the solution to
flush the probe.
5. Fill the same syringe
with DI water and flush
again from the top of
the probe. Repeat this
step three times.
NOTE: Empty the small
beaker as
necessary.
Reference
1 Probe Tubing
2 Probe Top
3 Wash Block
6. Hold the probe firmly

and reattach the Open
Mode tubing using
pliers to carefully work
the tubing back onto the
top of the probe.
portion of the
probe will allow
the tubing to slide
more easily.
7. Verify that the Open
Mode tubing is firmly
seated on the probe,
remove the small
beaker, and replace the
Processor Cover.
9-72
Section 9
Action
Steps
Maintenance
Activity Completion
1. Select Enable
Analyzer button.
2. Enter comments (e.g.
Flushed Open Probe)
in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
been performed.
NOTE: Selecting the
Cancel button in
not log the task.
Verification
Reference

to the Event Log, closes the 7002 Disable/Enable

view.
rinse the system.
3. Verify that the
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
Cover and verify the
component is not
leaking.
Cover.
9-73

Section 9
Vacuum Accumulator 1 and 2 Rinsing Procedure

Action
Rinse Vacuum Accumulators 1 and 2 with DI Water.

Steps
Prerequisite
1. Be sure that instrument is in the

Initialized or Ready state.
Materials Required
Clean 500 mL Beaker or Container

DI Water
12 inches of S3 Silicon Tubing
Preparation
1. Open Left Access (Front) Cover.
Reference
2. Remove the Left Panel from the

rear rail of the Autoloader.
Induce DI Water into
Vacuum Accumulators 1
and 2
1. Locate VAC 1 and VAC 2

accumulator drain lines. [1]
2. Measure and add 250 mL of DI
Water into a clean 500 mL beaker
or container.
CAUTION: Do not place more than
stated amount of DI water in
container.
1. Remove silicon portion of VAC1
drain line (along with plug) and
attach the 12 inch portion of S3
silicon tubing. [2]
2. Insert the end of the S3 silicon
tubing into the DI Water container
and allow the vacuum to aspirate
all of the liquid.
3. Remove the 12 inch piece of
silicon tubing and re-install the
original tubing along with plug.
4. Repeat Step 1 through Step 5 for
the VAC 2 drain line.
Drain Rinse Liquid with

Drain Accumulator
Protocol
9-74
1. From the Maintenance view,

Select
Special Protocols
Drain Accumulator
Drain Accumulator (from pop
up window).
Month
______
Clean WBC Lyse Syringe
Clean Sample Injection Syringe
Clean Closed Mode Needle
Clean Open Mode Probe
Clean Bar Code Reader Window
Clean Fan Filter
Extended Auto-Clean
Replace Transfer Pump Tubing
Replace Dil/Sheath Filter
Clean Shear Valve
Inspect Syringes
Clean Loader Components
Run Auto-Clean
______
9-75
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Day of the Month
It is recommended that this scheduled maintenance activity be performed on a weekly basis if your laboratory is running the Reticulocyte assay.
Calibration
NonReplace Tubing in Normally

Scheduled
Closed (NC) Valves
Procedures
Printer Cleaning
Replace Diluent/Sheath Syringe
Replace HGB Lyse Syringe
Replace Sample Injection Syringe
Replace Closed Mode Needle
Replace WBC Lyse Syringe
As-Needed Clean HGB Lyse Syringe

Procedures Replace Open Mode Probe
Monthly
Weekly
Daily
Year
CELL DYN Ruby

Maintenance Log
Section 9

Section 9
NOTES
9-76
Section 9
References
1. US Department of Labor, Occupational Safety and Health Administration, 29
CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens.
3. Clinical and Laboratory Standards Institute. Protection of Laboratory
Second Edition. CLSI document M29-A2 (ISBN 1-56238-453-8). CLSI, 940
9-77

Section 9
References
NOTES
9-78
Section 10 Troubleshooting and Diagnostics
Section 10
Troubleshooting and Diagnostics
Overview
This section provides the CELL-DYN Ruby operator with instructions for
identifying, troubleshooting and correcting instrument problems. The
Troubleshooting Guide is intended as a referral guide for customer troubleshooting
and optimal instrument operation and contains the following:
Introduction to Troubleshooting
Problem Categories
Troubleshooting Procedures
List of System Messages
System Information Message Tables
The CELL-DYN Ruby continuously monitors the status of the system and displays
pertinent information in the Analyzer Status region. If a problem is detected, a
system message will display in the System Messages region.
NOTE: Generally, conditions that are instrument- or reagent-related will occur on
all samples, including controls. Therefore, if a problem is detected or
suspected, it is important to confirm instrument performance by rerunning controls.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service or troubleshooting procedures.
Refer to Section 8: Hazards for additional information
If assistance is needed for any technical or operational problems, call your local
Country Service and Support Center.
When calling for assistance, be ready to provide the following information:
Instrument model and serial number
Software version
Problem description
Lot numbers and expiration dates of reagents, calibrator and controls
currently in use
Maintenance procedures recently performed
Troubleshooting steps taken
Any data gathered in the course of troubleshooting
10-1

Section 10
Overview
Introduction to Troubleshooting
Understanding normal instrument operation is essential for identifying and
resolving operational problems. Effective troubleshooting requires a logical, stepby-step approach to problem solving. Logical troubleshooting can be divided into
three steps as follows:
1. Problem Identificationrequires the Operator to investigate not only what
is wrong but also to note what is right. The investigation should identify the
problem area and eliminate areas that are working correctly. Once this step is
done, move to the next step.
2. Problem Isolationfurther classifies an instrument problem. These
problems are generally divided into three categories:
Measurement related to sample analysis
Software related
Hardware component related
Typically, hardware and software problems are Operator-correctable with
technical assistance. Measurement problems are generally Operatorcorrectable and are further subdivided into problems related to sample
handling, maintenance, or calibration.
3. Corrective Actioninvolves taking appropriate steps to correct the
problem. If the Operator can correct the problem, with or without technical
assistance, normal operation can quickly resume.
Problem Categories
Problems encountered when running the CELL-DYN Ruby can be classified into
three categories:
Observable problems
Problems that generate System Messages:
System Event Types
System Information Messages (SIMs)
Data-related problems
Observable Problems
Observable problems are easily noticed by the operator during routine operation or
maintenance. Examples of observable problems are salt deposits on the syringe
plunger or a flickering display.
10-2
Section 10
System Messages
Problems or system events that generate System Messages are detected by the
System and lead to the display of message text in the System Messages region. The
System software determines which System Messages will be historically
documented to the System Event Log. Refer to Subsection: List of System
Messages for the complete list of System Messages and SIM numbers. See also
Section 9: Service and Maintenance, Subsection: Event Log.
The System Messages region will display up to seven messages at one time, with
the most recent appearing at the top of the region. When a system message appears
in the System Messages region, the operator can point and roll the mouse cursor
over the message line to display the full system message description information:
Date and Time that the event occurred
Sequence Number that the event occurred
Type of system event:
Information
Warning
Operator-Correctable Fault
Sample Loader Fault
Fatal Fault
Description of the event
System Event Types
The following table contains the categories of event types that can display in the
System Messages region.
Event Type
ICON
Message Example
Information
Samples completed
Warning
QC Rule alert
WBC Lyse Empty
SL Fault (Sample Loader)
Rack bar code read failure
Fatal Fault
Analyzer failed to prime
10-3

Overview
Section 10
Information and Warning messages displayed in the System Messages region are
provided for informational purposes only and, based on their level of importance
for troubleshooting purposes, are documented to the System Event Log. They do
not have a System Information Message (SIM) dialog box associated with them.
Operator Correctable Fault (OCF), SL Fault, and Fatal Fault messages have an
associated SIM dialog box. Refer to Subsection: List of System Messages for the
complete list of System Messages and SIM numbers. See also Section 9: Service
and Maintenance, Subsection: Event Log.
System Information Messages (SIMs)
The System Information Message (SIM) dialog box will display when the System
detects certain conditions that are inconsistent with normal functioning. The SIM
dialog box indicates: a brief description of the event, an error code and the most
likely or least time consuming corrective action for the problem. If this corrective
action does not resolve the problem, refer to the Subsection: System Information
Message (SIM) Tables for additional instructions.
A SIM dialog box will have either one or a combination of two buttons (Clear
Fault or Save). The Clear Fault button will remove the SIM dialog box from the
view and the System Messages region. The Save button will remove the SIM
dialog box from the view but save the message in the System Messages region. The
operator can point and roll the mouse cursor over the message line to display the
full system message description information or point and click on the message line
to re-open the SIM dialog box. Saving messages that contain a Clear Fault button
causes the System to remain in an OCF or SL Fault State until the situation is
actually corrected and the SIM is cleared.
If a System action is required in order to clear a fault condition, then a Clear Fault
button is displayed in the SIM dialog box. The operator must select the Clear Fault
button to initiate the System action. In some cases, the operator is required to take
action (for example, emptying waste) before selecting the Clear Fault button. In
such cases, the operator action will be displayed in the corrective action field of the
SIM dialog box.
NOTE: If the System must perform an action to resolve the problem, the Analyzer
Status will indicate a current state when the action has been completed. If
the Analyzer Status indicates Ready State, sample processing can be
resumed. If the System or operator action does not clear the fault, samples
cannot be processed. Refer to Subsection: System Information Message
(SIM) Tables for additional instructions and if further action does not
clear the fault, you must contact your Country Service and Support Center
to resolve the problem.
10-4
Section 10
If the Analyzer Status indicates Fatal Fault State, only the Save button is available
in SIM dialog box. It is important for the operator to review the recommended
corrective action described in the SIM dialog box before selecting the Save button
to remove the SIM dialog box from the view but save the message in the System
Messages region. The operator can point and roll the mouse cursor over the
message line to display the full system message description information or point
and click on the message line to re-open the SIM dialog box. Saving messages that
only contain a Save button causes the System to remain in a Fatal Fault State until
the situation is actually corrected.
Data-Related Problems
Data-related problems are noticed by the operator during review and analysis of
result data. This category includes problems that cause elevated backgrounds,
imprecision, or trends or shifts in control data.
NOTE: If the controls are out of range or if the instrument appears to be
inaccurate, follow your laboratorys protocols to determine whether
calibration is required. If necessary, refer to Section 6: Calibration
Procedures for details.
Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes only. A specific
procedure should be performed under one of the following conditions:
1. To correct a problem described in this section.
2. At the request of an Abbott Customer Service Specialist.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service or troubleshooting procedures.
Refer to Section 8: Hazards for additional information.
Troubleshooting Tips and Techniques

Effective troubleshooting is possible only when the problem is clearly recognized
and the probable cause is isolated. This is always facilitated by obtaining sufficient
information and data pertaining to the specific problem. Carefully observe the
situation. Document the steps that have been taken and record all results. The
following section is designed to guide the operator through a logical series of steps
to obtain information regarding the nature of the problem. If it is necessary to call
for technical assistance, this information should be made available to the Country
Troubleshooting the Background Count
1. Determine which parameter(s) exceed the background count specifications:
WBC, RBC, PLT, HGB, NOC.*
* Background counts for NOC are available on the Datalog and QC View,
Diff tab.
10-5

Section 10
Overview
2. Check the Datalog to determine when the problem first occurred.

3. Check the Reagent Log, Maintenance Log and, if applicable, service reports
to see if the problem occurred immediately after a specific action. For
example, did the problem occur immediately after the reagent was changed?
4. Check the Background count in the open and closed modes to see if the
problem is common to both modes. Refer to Section 5: Operating
Instructions, Subsection: Running Background Counts.
5. Note the lot number of the reagent. Is it a new lot?
6. Configure the Run View to display the appropriate graphic for the
parameter(s) for which the background exceeds the specifications:
Parameter
Appropriate Graphic
WBC
WBC Histogram/Scatterplots
RBC
RBC and PLT Histograms/Scatterplots
PLT
RBC and PLT Histograms/Scatterplots
HGB
WBC, RBC and PLT Histograms
NOC
NOC Histogram
Obtain several printouts of this information by running multiple background

cycles.
NOTE: Instructions for customizing the Run View, see Section 2:
Installation Procedures and Special Requirements, Subsection:
System Customization.
7. Configure the Datalog to display values for WBC, RBC, PLT, HGB, and
NOC. Obtain printouts of the Data Log, including the sequence numbers of
the background cycles.
NOTE: Instructions for customizing the Datalog, see Section 2:
Troubleshooting Reagent Problems
If a reagent (or reagents) is suspected as the cause of a particular problem, replace
it. However, the Analyzer has reservoirs that contain a small amount of reagent to
maintain the supply within the system. This supply must be depleted before
installing the new reagent.
NOTE: There is no reservoir for the HGB Lyse reagent. The amount of HGB Lyse
contained in the lyse supply tubing is sufficient to maintain the systems
supply. The HGB Lyse tubing is drained and filled by pressing the
appropriate reagent key displayed on the Special Protocol Empty/Fill
Reagent Reservoir dialog box described below.
10-6
Section 10
To ensure that the new reagent is actually in the system, proceed as follows:
1. From Maintenance view, Special Protocols tab, select the Empty/Fill
Reagent Reservoir task button.
2. From the Empty/Fill Reagent Reservoir dialog box, select button for the
desired reagent and follow the instructions given on the screen.
3. Wipe the reagent line with a lint-free wipe before placing it in the new
container. Place the line in the container and secure the cap.
4. Select the button to refill the reservoir.
5. Run five Background counts before assessing the results.
NOTE: Verify background count results are within acceptable limits prior
to running controls or patient specimens.
Troubleshooting the Sampling error-incomplete aspiration
Message
1. Check to see if the problem occurs in both the Open and Closed Modes of
operation. If the problem is confined to one mode only, the other may be
eliminated as the cause of the problem.
2. Determine whether the problem is a true incomplete aspiration. Run a sample
and verify that blood is visible in the sample tubing above the appropriate
probe or needle.
3. Verify that blood is pulled through the Shear Valve. Blood should be visible
in the lines (approximately one inch) on both sides of the Shear Valve before
it rotates.
Troubleshooting a Flow Error Message
1. The flow error messages indicate a problem with the kinetic rate of the WBC,
RBC/PLT, or NOC measurements. The kinetic information is available
immediately after the run cycle is finished in the Count Rate Summary file.
2. Select Run View, then select Diagnostics, Diagnostics Views from the menu
bar to add the Diagnostics Views tab to the Run View.
3. Using the mouse, click open the Count Rate Summary file to access the
count rate data and graph views for WOC, RBC/PLT, or NOC.
4. Click on the view you wish to print and select F1 Print.
5. Configure the Run View to display the WBC Size/Complexity scatter and the
WBC N-L-M histogram. Obtain several printouts. This information can help
to determine if the flow is erratic or just momentarily interrupted.
10-7

Section 10
Overview
Troubleshooting Imprecise or Inaccurate Data

1. Obtain a normal blood sample. Select Calibration, Quick Precision Check
from the menu bar to open the Quick Precision Check dialog box.
2. Enter the Specimen ID and run a minimum of ten Open Mode runs, then press
the Print button.
3. Select the New Precision Check button to clear the dialog box and run a
minimum of ten closed mode runs, then press the Print button.
4. Review the information to determine if the problem is mode or measurement
related.
5. Obtain printouts of related data as indicated in the following steps.
6. WBC:
Configure the Run View to display the following and select F1 Print. (This
requires two printouts per sample.)
Printout 1:
WBC: Size-Cmp (010)
WBC: Grn-Lob (90D90)
WBC: 900 deg Scatter
WBC: N-L-M histogram
WBC: M-P histogram
RBC: 9010 deg Scatter
Printout 2:
NOC: NOC histogram
Obtain printouts of the Count Rate Summary view, WOC Count Rate
Data, and WOC Count Rate Graphs view for several samples. See
previous procedure: Troubleshooting a Flow Error Message.
Select the Raw Data Summary view, then select F1 Print immediately
after the problem sample is run from the Diagnostics View tab.
If there is a flagging problem or a problem with an abnormal sample, obtain
a printout of a normal sample for comparison.
Configure the Datalog to display and print WBC and NOC values. Print the
results for the last 100 cycles.
10-8
Section 10
7. RBC, HGB, MCV and PLT:

Configure the Run View to display the following and select F1 Print of
problem samples.
RBC 010 deg Scatter
RBC 9010 deg Scatter
RBC RBC Volume
RBC RBC/PLT 0 Histogram
RBC RBC/PLT 10 Histogram
RBC PLT Histogram
Select the Raw Data Summary view, then select F1 Print immediately
after the problem sample is run from the Diagnostics View tab.
Select QC View, F5 - Moving Average, F1 Print to obtain a printout of
the X-B tab view. Select the RBC tab view and scroll to view the Hemoglobin
Sample Mean HbS Mn and the Hemoglobin Reference Mean HbR Mn
columns, press the Print Scrn key on the keyboard to obtain a printout.
Check the Hemoglobin Reference and verify that its values are within 2050
250.
Check the hemoglobin Flow Cell if the reference value is <1800.
If the Hemoglobin Reference Value is >2300, call your local Country Service
and Support Center.
8. NOC:
Obtain the same information given in step 6.
Obtain printouts of the Count Rate Summary view, NOC Count Rate
Data, and NOC Count Rate Graphs view for several samples. See previous
procedure: Troubleshooting a Flow Error Message.
10-9

Section 10
Overview
Troubleshooting Imprecise or Inaccurate Data

Probable Cause
Corrective Action
1. Improper Sample Mixing
1. Verify all samples are well-mixed prior to analysis.

(Refer to Section 5: Operating Instructions,
Subsection: Routine System Startup.)
2. Dirty Syringe(s)
1. Inspect/Clean syringe as directed is

Section 9: Service and Maintenance,
Subsection: Scheduled Maintenance
Procedures.
3. Leaking Syringe(s)
1. Inspect syringe for evidence of leaks.

2. Verify syringe connectors are secure.
3. Remove/Clean/Replace syringe as directed in
Procedures.
4. Dirty Shear Valve
1. Clean shear valve as directed in

Procedures.
5. Worn Sample Transfer Pump Tubing
1. Inspect/Replace sample transfer pump tubing as

directed in Section 9: Service and
Maintenance, Subsection: Scheduled
10-10
Section 10
List of System Messages

The following table lists the System Messages and SIMs that can be displayed in
the System Messages Region on the CELL-DYN Ruby.
SIM ID Numbers
Message Text
Event Type
Saved to Event Log
N/A
Initialization succeeded
Information
Yes (not displayed in

System Messages region)
N/A
Initialization Start: sw ver

xxxx
Information

N/A
Prime finished auto bkg

to follow
Information

N/A
Starting Auto Background
Information

N/A
Admin password was

reset
Information

N/A
Cant change to/from retic

in current state
Warning
No
N/A
Specimen ID name must

include between 3 and 20
non-space characters
Warning
No
0102
3 Consecutive Flow Errors
Warning
Yes
0103
Sampling error
incomplete aspiration
Warning
Yes
0104
Processor Tower cover

open
SL Fault
Yes
0118
RETIC Test Selection, but

not in RETIC mode
Warning
No
0119
Non-RETIC Test Selection,

but in RETIC mode
Warning
No
0120
QC Rule Alert in QCID

XXXXX for Seq YYYY
Warning
Yes
0121
No tube present
SL Fault
Yes
0122
Samples completed
Information
Yes
10-11

Section 10
Overview
SIM ID Numbers
Message Text
Event Type
Saved to Event Log
0123
3 Consecutive Short
Samples
Warning
Yes
0124
WOC flow error
Warning
No
0125
NOC flow error
Warning
No
0126
RBC flow error
Warning
No
0127
Retic flow error
Warning
No
0128
Retic bar code read in

closed mode
Warning
Yes
0129
Bar code xx mismatch for

order Rxx Tyy
Warning
Yes
0130
Rxx Tyy order and QCID

mismatch
Warning
Yes
0131
Processor Tower Cover

Open
Operator Correctable
Fault
Yes
0643
WBC Lyse Empty
OCF
Yes
0644
HGB Lyse Empty
OCF
Yes
0645
Dil/Sheath Empty
OCF
Yes
0646
Waste Full
OCF
Yes
0647
WBC Lyse reagent left <

10% (x%)
Warning
Yes
0648
HGB Lyse reagent left <

10% (x%)
Warning
Yes
0649
Dil/Sheath reagent left <

10% (x%)
Warning
Yes
0840
Vacuum Accumulator #1
Wet
Fatal Fault
Yes
0841
Vacuum Accumulator #2
Wet
Fatal Fault
Yes
0842
Shear valve position fault
Fatal Fault
Yes
10-12
Section 10
SIM ID Numbers
Message Text
Event Type
Saved to Event Log
0843
RBC diluent syringe

overpressure
Fatal Fault
Yes
1093
Mix head failed to

complete downward
rotation
SL Fault
Yes
1094
Mix head failed to

complete upward rotation
SL Fault
Yes
1095
Mix head not at top

position
SL Fault
Yes
1096
Mix head stuck at top

position
SL Fault
Yes
1097
Tube stuck in position 3
SL Fault
Yes
1098
SL Fault
Yes
1099
Invalid tube height
SL Fault
Yes
1100
Tube dropped during

mixing
SL Fault
Yes
1101
Mix zone rack position

error
SL Fault
Yes
1102
Unexpected tube in
position 4 after rack
advance
SL Fault
Yes
1103
Tube lost moving from

position 3 to position 4
SL Fault
Yes
1104
Mix zone must be cleared

for reset
SL Fault
Yes
1105
Excessive cycling
SL Fault
Yes
1106
Unload area full
Information
Yes
1107
Unload area hardware

malfunction
SL Fault
Yes
1108
Closed mode needle stuck

at home position
SL Fault
Yes
10-13

Section 10
Overview
SIM ID Numbers
Message Text
Event Type
Saved to Event Log
1109
Closed mode needle

unable to reach home
position
SL Fault
Yes
1111
Load zone empty
Information
Yes
1257
Shear valve position

sensor fault
Fatal Fault
Yes
1631
WOC heater temperature

out of range
Warning
Yes
1632
HGB heater temperature

out of range
Warning
Yes
1633
Three consecutive WOC

heater errors
Warning
Yes
1634
Three consecutive HGB

heater errors
Warning
Yes
1851
Database Auto-Backup
failure
Warning
Yes
1852
Database Transaction Log

Auto-backup failure
Warning
Yes
2072
Analyzer initialization
failed
Fatal Fault
Yes
2073
Error opening A32MAIN.S
Fatal Fault
Yes
2074
Error opening Fsq <name

of Fsq>
Fatal Fault
Yes
2075
Unable to open HSSL

driver
Fatal Fault
Yes
2076
HSSL Error
Fatal Fault
Yes
2077
Flow script timeout <name

of fsq>
Fatal Fault
Yes
2078
Invalid Parameter in Fsq

<name of fsq>
Fatal Fault
Yes
2079
Invalid Macro in Fsq

<name of fsq>
Fatal Fault
Yes
10-14
Section 10
SIM ID Numbers
Message Text
Event Type
Saved to Event Log
2080
HSSL bad command or

command sent at
inappropriate time
Fatal Fault
Yes
2081
HSSL bad command or

command sent at
inappropriate time
Warning
Yes
2082
Message ack timeout on

Analyzer
Fatal Fault
Yes
2083
Analyzer monitor (bios)

received illegal command
Fatal Fault
Yes
2084
Runtime error in Analyzer

Module
Fatal Fault
Yes
2085
DMA controller error during

list mode acquisition
Fatal Fault
Yes
2086
DMA controller setup error
Fatal Fault
Yes
2088
Bad checksum in nonvolatile RAM
Fatal Fault
Yes
2089
Incorrect FSQ command

on Analyzer
Fatal Fault
Yes
2090
Sample handler command

negatively acknowledged
Fatal Fault
Yes
2091
Flow sequence timeout on

Analyzer
Fatal Fault
Yes
2092
Retransmission error on
Analyzer
Fatal Fault
Yes
2093
<Tower or Loader>
transmission failure
Fatal Fault
Yes
2094
<Tower or Loader>
communication failure
Fatal Fault
Yes
2095
<Tower or Loader> direct

command parameter error
Fatal Fault
Yes
2096
<Tower or Loader> motor

command timing error
SL Fault
Yes
10-15

Section 10
Overview
SIM ID Numbers
Message Text
Event Type
Saved to Event Log
2097
<Tower or Loader> invalid

direct command
Fatal Fault
Yes
2098
<Tower or Loader> invalid

processing command
Fatal Fault
Yes
2099
Fatal Fault
Yes
2100
HSSL timeout
Fatal Fault
Yes
2237
SL Fault
Yes
2238
Tube position bar code

read failure
SL Fault
Yes
2442
Unable to open
communication
Warning
Yes
2443
LIS transmit Err:

invalid specid
Warning
Yes
2444
LIS transmit Err:

already on LIS queue
Warning
Yes
10-16
Section 10
System Information Message (SIM) Tables

The following tables give the number, message, probable cause(s), and corrective
action(s) for System Information Messages (SIMs).
0102
3 Consecutive Flow Errors
Event Type:
Warning
The Analyzer Status region indicates Ready.

NOTE: The Loader halts at the end of the cycle in process.
Probable Cause(s)
Corrective Action(s)
Three consecutive flow error messages (of the 1. Three consecutive flow errors of the same type
same type) occurred during Loader operation.
will cause the Loader to halt. Refer to
Subsection: Troubleshooting a Flow Error
Message.
2. If unable to resolve this problem, contact
Abbott Customer Service.
0103
Sampling error incomplete aspiration
Event Type:
Warning
The Analyzer Status region indicates current state.

NOTE: This message does not halt the Loader.
SAMPLING ERROR is displayed to the right of the PLT result in the Run View.
SAMPLING ERROR is printed on all reports. Results may look like background counts.
Probable Cause(s)
The sensor system did not detect a sufficient

amount of sample at the expected time
following aspiration.
1. Check the specimen tube to be sure it contains a

sufficient quantity of sample. Verify that the
specimen contains no clots.
2. Clean the Open Mode Probe or the Closed
Mode Needle as directed in Section 9: Service
and Maintenance, Subsection: 6052 Clean
or Replace Open Mode Probe or 6053 Clean
or Replace Closed Mode Needle to remove any
obstructions.
3. Clean the Shear Valve as directed in Section 9:
Service and Maintenance, Subsection: 6006
Clean Shear Valve.
10-17

Section 10
Overview
0104
Processor Tower cover open
Event Type:
SL Fault
The Analyzer Status region indicates Loader Fault.

NOTE: The Loader halts.
The circuit formed when the Processor cover in place has been broken.
Probable Cause(s)
The System in Closed Mode and the

1. Reinstall or reset the Processor cover. Make
Processor Tower Cover has been removed or
sure the cover is held in position by the magnets
is not seated properly.
on the instrument frame.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
A failure of the sensor or related electronics
has occurred.
0118
If unable to resolve this problem, contact Abbott

Customer Service.
RETIC Test Selection, but not in RETIC Mode
Event Type:
Warning

The software has identified a Specimen ID match within the Pending Orders during Specimen ID entry in the
Next Open Tube Entry region; however, the test selection for the Specimen ID in the Pending Orders does not
match the current test selection in the Next Open Tube Entry region.
Probable Cause(s)
Specimen ID in the Pending Orders does not 1. Update the Test Selection in the Next Open
match the current test selection in the Next
Tube Entry region to match the test selection in
Open Tube Entry region.
the Pending Orders and process the specimen.
NOTE: When this action is complete, the
matched Pending Order will be removed.
2. (Optional) Process the specimen but do not
update the Test Selection in the Next Open
Entry region to match the test selection in the
Pending Orders.
demographic information for the Specimen ID
is transferred to the Next Open Tube Entry
(Detailed) window; however, the Specimen ID
record remains in Pending Orders.
10-18
Section 10
0119
Non-RETIC Test Selection, but in RETIC mode
Event Type:
Warning

The software has identified a Specimen ID match within the Pending Orders during Specimen ID entry in the
Next Open Tube Entry region; however, the test selection for the Specimen ID in the Pending Orders does not
match the current test selection in the Next Open Tube Entry region.
Probable Cause(s)
Specimen ID in the Pending Orders does not 1. Update the Test Selection in the Next Open
Tube Entry region to match the test selection in
match the current test selection in the Next
the Pending Orders and process the specimen.
Open Tube Entry region.
matched Pending Order will be removed.
2. (Optional) Process the specimen but Do Not
update the Test Selection in the Next Open
Entry region to match the test selection in the
Pending Orders.
demographic information for the Specimen ID
is transferred to the Next Open Tube Entry
(Detailed) window; however, the Specimen ID
record remains in Pending Orders.
0120
QC Rule Alert in QCID XXXXX for Seq YYYY
Event Type:
Warning

The QC Status region Rule Alert: indicates Yes.
One or more of the Westgard Rules has been violated.
Probable Cause(s)
The data in the QCID file has violated one or Review the data in the QCID file and take
more of the enabled Westgard Rules selected appropriate action.
during set up of the QCID file.
10-19

Section 10
Overview
0121
No tube present
Event Type:
SL Fault

Probable Cause(s)
The tube being processed is not tall enough.

has occurred.
0122
1. Verify recommended collection tube

dimensions for use in closed mode. See
Section 7: Operational Precautions and
Limitations for recommended collection tube
dimensions for use in Loader Mode.
2. Reset the Racks.
3. Reset the Loader by pressing the following keys
in order; Clear Fault, Start Loader, Reset Loader.
If unable to resolve this problem, contact Abbott
Customer Service.
Samples completed
Event Type:
Information

The last rack in the load zone has been processed. No corrective action is necessary. When you wish to run
additional samples in the Loader, load racks and press the Start Loader key.
0123
3 Consecutive Short Samples
Event Type:
Warning
The Analyzer Status region indicates READY.

Probable Cause(s)
Three consecutive 0103 Sampling error

incomplete aspiration messages occurred
during Loader operation.
1. Three consecutive 0103 Sampling error

incomplete aspiration messages will cause the
Loader to halt. Refer to Subsection:
Troubleshooting the Sampling errorincomplete aspiration Message.
10-20
Section 10
0124
WOC flow error
Event Type:
Warning

WOC FLOW ERROR is displayed to the right of the EOS result in the Run View.
WOC FLOW ERROR is printed on all reports. The invalid numerical results for WBC and Differential are
marked with an asterisk [*]. Review all results marked with an asterisk. Follow your laboratorys procedures.
Probable Cause(s)
An increasing WOC count rate was detected

in the optical flow cell during the WOC
measurement.
Rerun the specimen.
Optical flow cell is dirty or contains bubbles. 1. Select Maintenance, Special Protocols tab.
a. Perform Empty/Fill Optical Flow Cell.
2. Select Scheduled tab.
a. Perform Auto-Clean and/or Extended
Auto-Clean.
Sample dilution delivery problem.
1. Select Maintenance, Scheduled tab.

a. Perform Replace Transfer Pump Tubing.
2. Clean Sample Injection Syringe, check for
leakage, and replace as necessary.
Dil/Sheath flow (partially) obstructed.

a. Perform Replace Dil/Sheath Filter.
10-21

Section 10
Overview
0125
NOC flow error
Event Type:
Warning

NOC FLOW ERROR is displayed under the BASO result in the Run view.
NOC FLOW ERROR is printed on all reports. The invalid numerical results for WBC and Differential are
Probable Cause(s)
An increasing NOC count rate was detected

in the optical flow cell during the NOC
measurement.
Rerun the specimen.
Auto-Clean.


10-22
Section 10
0126
RBC flow error
Event Type:
Warning

RBC FLOW ERROR is displayed to the right of the RDW result in the Run view.
RBC FLOW ERROR is printed on all reports. The invalid numerical results for RBC, PLT, and related
parameters are marked with an asterisk [*]. Review all results marked with an asterisk. Follow your
laboratorys procedures.
Probable Cause(s)
An increasing RBC count rate was detected in Rerun the specimen.

the optical flow cell during the RBC
measurement.
Auto-Clean.


10-23

Section 10
Overview
0127
Retic Flow error
Event Type:
Warning

FLOW ERROR is displayed under ALERTS in the Run view.
FLOW ERROR is printed on all reports. The invalid numerical results for %R and RETC parameters are
Probable Cause(s)
An increasing Retic Count rate was detected

in the optical flow cell during the Retic
measurement.
Rerun the Reticulocyte specimen.
An air bubble.
Run a background count to cycle air through the

system and rerun the Reticulocyte specimen.
If problem occurs repeatedly, refer to Subsection:
Troubleshooting a Flow Error Message
0128
Retic bar code read in closed mode
Event Type:
Warning

When this message appears, the System has detected a tube labeled with a reticulocyte QCID or a reticulocyte
Specimen ID bar code label during Closed Mode processing. The System will run the default patient test
selection and the <Spec ID> field will be replaced with the <Rxx Tyy> (rack and tube) position.
NOTE: The CELL-DYN Ruby Reticulocyte assay is run in the Open Mode only. See Section 12: Reticulocyte
Package for more information on running reticulocyte specimens.
Probable Cause(s)
A reticulocyte QCID or a reticulocyte

Specimen ID bar code label was read during
Closed Mode processing.
No corrective action is necessary.

Rerun the specimen in the Open Mode using the
RETIC test selection.
See also Section 12: Reticulocyte Package.
10-24
Section 10
0129 Bar code xx mismatch for order Rxx Tyy

Event Type:
Warning

When this message appears, the Orders Setup dialog box has been configured to use rack and tube matching
and the System has detected that the bar code label specimen ID on the tube is different from the specimen ID
in the rack and tube order. The System will process the specimen using the Default Patient Test Selection and
the Spec ID field in the Datalog will be replaced with the specimen rack and tube position information.
0130 Rxx Tyy order and QCID mismatch

Event Type:
Warning

When this message appears, the Orders Setup dialog box has been configured to use rack and tube matching
and the System has detected that the bar code label specimen ID on the tube matches a QCID file and does not
match the specimen ID in the rack and tube order. The System will run the QCID test selection with results
placed into the QCID file. The rack and tube order from the Pending Orders log is not deleted.
0131 Processor Tower Cover Open

Event Type: Operator Correctable Fault
The Analyzer Status region indicates OCF.
NOTE: After the current sample completes, no more samples can be run.
Probable Cause(s)
1. The operator requests system

initialization and the processor
cover has been removed or is not
seated properly.
1. Reinstall or reset the processor cover.

2. Press Clear Fault to close the SIM dialog box.
2. The system is processing an open

mode aspiration and the processor
cover has been removed or is not
seated properly.
10-25

Section 10
Overview
0643
WBC Lyse Empty
Event Type:
The Analyzer Status region indicates Op Correc. Fault.

Probable Cause(s)
Container is empty.
1. Install a new container of reagent.

2. Press Clear Fault.
NOTE: Do not pour any remaining reagent
into the new container.
3. Enter new reagent information.
4. Run 5 or more background counts and review
results. Background results must be within
acceptable limits before running controls or
patient specimens.
5. Run a whole blood before QC or Patient testing.
Reagent inlet tubing is crimped or

obstructed.
Inspect the whole length of the inlet tubing to ensure

it is not crimped and/or remove any obstruction.
Reagent line is not on the bottom of the

container.
Ensure that the line is properly inserted in the

container and the sinker is on the bottom of the
container.
An incorrect reagent or a nonconductive

liquid is connected to the inlet tube.
1. Check the label on the reagent container to be

sure the correct reagent is installed.
2. Trace the line to the inlet connector and ensure
that it is connected to the correct one.
3. Check the connection to be sure it is secure and
then press Clear Fault.
Appropriate syringe not mounted properly.
Check proper mounting of syringes.
The Luer fitting connection on the top of the

appropriate syringe is loose.
Verify the Luer connection on the top of syringes is

secure.
The tubing in solenoid valve is pinched or not 1. Check tubing in N/C valve 23 (WBC Lyse) is
fully inserted.
not pinched or obstructed; replace as necessary.
2. Verify tubings are fully inserted in solenoids 23,
25 (WBC Lyse).
Circuitry malfunction.
10-26
Contact Abbott Customer Service.
Section 10
0644
HGB Lyse Empty
Event Type:

Probable Cause(s)
Container is empty.

patient specimens.

obstructed.


container.

container.


The Luer fitting connection on the top of

the appropriate syringe is loose.

secure.
The tubing in solenoid valve is pinched or

not fully inserted.
1. Check tubing in N/C valve 28 (HGB Lyse) is

not pinched or obstructed; replace as necessary.
2. Verify tubings are fully inserted in solenoids 28,
24 (HGB Lyse).
10-27

Section 10
Overview
0645
Dil/Sheath Empty
Event Type:

Probable Cause(s)
Container is empty.

patient specimens.

obstructed.


container.

container.


10-28
The Luer fitting connection on the top of

the appropriate syringe is loose.

secure.
Section 10
0646
Waste Full
Event Type:

Probable Cause(s)
External waste container full.
WARNING: Potential Biohazard.

Identifies an activity or area where you may
be exposed to potentially infectious material.
Empty the waste container and/or replace it. Press
Clear Fault to resume operation.
NOTE: Make sure the Analyzer rinse process has
been completed before removing the waste
tube.
0647
Waste sensor connector is loose or

disconnected.
Reconnect the waste sensor connector and then

press Clear Fault.
Shorted wire(s) or electrode(s) on the waste

cap.
Visually inspect wires and electrodes and call for

technical assistance.
If the message appears repeatedly, contact Abbott

Customer Service.
WBC Lyse reagent left < 10% (x%)
Event Type:
Warning

The amount of WBC Lyse reagent in the container is less than 10%. The message displays the actual percentage
of reagent left in the parentheses (x%). No corrective action is necessary. SIM 0643 WBC Lyse Empty message
will alert the operator when reagent container replacement is required.
0648
HGB Lyse reagent left < 10% (x%)
Event Type:
Warning

The amount of HGB Lyse reagent in the container is less than 10%. The message displays the actual percentage
of reagent left in the parentheses (x%). No corrective action is necessary. SIM 0644 HGB Lyse Empty message
will alert the operator when reagent container replacement is required.
10-29

Section 10
Overview
0649
Dil/Sheath reagent left < 10% (x%)
Event Type:
Warning

The amount of Diluent/Sheath reagent in the container is less than 10%. The message displays the actual
percentage of reagent left in the parentheses (x%). No corrective action is necessary. SIM 0645 Dil/Sheath
Empty message will alert the operator when reagent container replacement is required.
0840
Vacuum Accumulator #1 Wet
Event Type:
Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s)
Liquid is detected in Vacuum Accumulator

#1.
1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. Select Maintenance, Special Protocols tab.
a. Perform Drain Accumulators procedure.
b. Perform Initialize Analyzer.
c. Perform Vacuum Accumulator 1 and 2
Rinsing Procedure. Refer to Section 9:
Service and Maintenance, Subsection:
Nonscheduled Maintenance Procedures.
d. Perform Prime.
are within acceptable limits prior to running
10-30
Section 10
0841
Vacuum Accumulator #2 Wet
Event Type:
Fatal Fault

Probable Cause(s)
Liquid is detected in Vacuum Accumulator

#2.

action.
box.
3. Select Maintenance then Special Protocols
tab.
a. Perform Drain Accumulators procedure
two times.
b. Perform Initialize Analyzer.
c. Perform Vacuum Accumulator 1 and 2
Rinsing Procedure. Refer to Section 9:
Nonscheduled Maintenance Procedures.
d. Perform Prime.
10-31

Section 10
Overview
0842
Shear valve position fault
Event Type:
Fatal Fault

Probable Cause(s)
The Shear Valve did not rotate properly or in 1. Review the following recommended corrective
the allotted time.
action.
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance then Scheduled tab.
a. Perform Clean Shear Valve.
a. Perform Initialize Analyzer.
b. Perform Prime.
6. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
Sensor or cable malfunction.
10-32
If the problem occurs repeatedly, contact Abbott

Customer Service.
Section 10
0843
RBC diluent syringe overpressure
Event Type:
Fatal Fault

Diluent/Sheath syringe attempted to move up and pressure exceeding the allowed limit was detected in the
Diluent/Sheath line.
Probable Cause(s)
action.
the allotted time and a blockage obstructs the
Diluent/Sheath reagent distribution through 2. Press the Save button to close the SIM dialog
the flow system.
box.
4. Reboot the system.
Power Off.
b. Perform Prime.

Customer Service.
10-33

Section 10
Overview
1093
Mix head failed to complete downward rotation
Event Type:
SL Fault

The Mix Head failed to return to its vertical position.
Probable Cause(s)
A mechanical problem is preventing the Mix 1. Remove the Processor Cover.

Head from rotating downward.
2. Check for an obstruction that is preventing the
Mix Head from rotating downward. If an
obstruction is found, remove it.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the optical sensor or related
electronics has occurred.
1094

Customer Service.
Mix head failed to complete upward rotation
Event Type:
SL Fault

The Mix Head failed to move from its vertical position.
Probable Cause(s)
A mechanical problem is preventing the Mix 1. Remove the Processor Cover.

Head from rotating upward.
Mix Head from rotating upward and, if one is
found, remove it.
Reset Loader.
10-34

Customer Service.
Section 10
1095
Mix head not at top position
Event Type:
SL Fault

The Mix/Lift Assembly failed to reach its top position.
Probable Cause(s)
A mechanical problem is preventing Mix/Lift 1. Remove the Processor Cover.

Assembly is from moving upward.
Mix/Lift Assembly from moving upward and, if
one is found, remove it.
Reset Loader.
1096

Customer Service.
Mix head stuck at top position
Event Type:
SL Fault

The Mix/Lift Assembly failed to move from its top position.
Probable Cause(s)
A mechanical problem is preventing the Mix/ 1. Remove the Processor Cover.

Lift Assembly from moving downward.
Mix/Lift Assembly from moving downward
and, if one is found, remove it.
Reset Loader.

Customer Service.
10-35

Section 10
Overview
1097
Event Type:
SL Fault

The sensor for tube position 3 in the mixing zone is sensing the presence of a tube when the tube should be
lifted clear of the rack by the Mix Head.
Probable Cause(s)
The tube in position 3 has liquid on it.

2. Dry the tube in position 3 and verify that it is not
leaking.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The tube in position 3 either has a loose bar

code label or too many bar code labels.
1. If the bar code label is loose, secure it in place.

If multiple bar code labels are on the tube,
remove them and carefully apply a single bar
code label.
NOTE: For information concerning proper
application of bar code labels, refer to
Section 4: Performance Characteristics and
Specifications, Subsection: Bar Code Label
Placement:.
2. Reset the racks, and reset the Loader by
pressing the following keys in order: Clear
Fault, Start Loader, Reset Loader.
10-36
Section 10
1097
Tube stuck in position 3 (Continued)
Event Type:
SL Fault

The sensor for tube position 3 in the mixing zone is sensing the presence of a tube when the tube should be
lifted clear of the rack by the Mix Head.
Probable Cause(s)
The Mix Head Tube Grippers are dirty.

2. Using a lint-free wipe moistened with a 0.5%
sodium hypochlorite solution, clean the Mix
Head Tube Grippers. Refer to Section 9:
Clean Loader Components. (See the formula
for mixing this solution under Section 9:
Decontamination Procedures.)
3. Repeat Step 2 with deionized water. Dry the
Mix Head thoroughly.
Reset Loader.

has occurred.

Customer Service.
10-37

Section 10
Overview
1098
Event Type:
SL Fault

The sensor for tube position 4 in the mix zone is sensing the presence of a tube when the tube should be lifted
clear of the rack.
Probable Cause(s)
The tube in position 4 has liquid on it.

2. Dry the tube in position 4 and verify that it is not
leaking.
3. Reinstall the Processor Cover. Reset the racks.
Loader.
The tube in position 4 either has a loose bar

code label or too many bar code labels.
1. If the bar code label is loose, secure it in place.

If multiple bar code labels are on the tube,
remove them and carefully apply a single bar
code label.
NOTE: For information concerning proper
application of bar codes, refer to Section 4:
Performance Characteristics and
Specifications, Subsection: Bar Code Label
Placement:
2. Reset the racks, and reset the Loader by
pressing the following keys in order: Clear
Fault, Start Loader, Reset Loader.
The Mix Head Tube Grippers are dirty.

Reset Loader.
10-38
Section 10
1098
Tube stuck in position 4 (Continued)

Probable Cause(s)
The tube position sensor is dirty.

2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors (the tube position 4 sensor is on the
left). Dry the sensors thoroughly.
Components.
Reset Loader.

has occurred.

Customer Service.
10-39

Section 10
Overview
1099
Invalid tube height
Event Type:
SL Fault

The tube height sensor system indicates that the tube at the Aspiration Station exceeds height specification.
Probable Cause(s)
The instrument cannot accommodate the

height of the tube.
1. Verify recommended collection tube

dimensions for use in Closed Mode. Section 7:
Operational Precautions and Limitations,
Subsection: Requirements for Handling
Specimens for recommended collection tube
dimensions for use in Loader Mode.

has occurred.

The tube height sensor flag on the aspiration

tower is not moving into position properly
because the Guide Shafts are obstructed or
dirty.
The Guide Shafts are the three vertical bars on the

aspiration tower.
tube spinning assembly with tube height sensor
flag from moving up and down properly and, if
one is found, remove it.
3. Using a lint-free wipe moistened with isopropyl
alcohol, clean the Guide Shafts.
4. Reinstall the Processor cover. Reset the racks.
Loader.
The tube height sensor flag is bent or the

tower sensors, motor, or related electronics
are defective.
10-40
Section 10
1100
Tube dropped during mixing
Event Type:
SL Fault

A tube was sensed as missing from tube position 3 or 4 after the mixing cycle.
Probable Cause(s)
The tube in position 3 or 4 has liquid on it.

2. Dry the tubes in position 3 and 4, and verify that
they are not leaking.
Loader.
The Mix Head Tube Gripper is dirty.

Loader.
A failure of the sensor system or related


sensors. Dry the sensors thoroughly.
Components.
Loader.
10-41

Section 10
Overview
1100
Tube dropped during mixing (Continued)
Event Type:
SL Fault

A tube was sensed as missing from tube position 3 or 4 after the mixing cycle.
A failure of the bladder or bladder pressure
system has occurred.
1101
Mix zone rack position error
Event Type:
SL Fault

The rack tube position bar code number read was not the number expected.
Probable Cause(s)
The rack did not advance.

rack from advancing and, if one is found,
remove it.
The rack and/or Loader Tray are dirty.
1. Select Clear Fault.

2. Reset the racks before proceeding to the next
step.
a. Perform Clean Loader Components.
in order: Start Loader, Reset Loader.
A failure of the Air Cylinder or a failure in the Contact Abbott Customer Service.
Air Cylinder pressure system has occurred.
10-42
Section 10
1102
Unexpected tube in position 4 after rack advance
Event Type:
SL Fault

A tube was not sensed in tube position 3 before a rack advance, but a tube was sensed in tube position 4 after
a rack advance.
Probable Cause(s)

remove it.

step.
A failure of the Air Cylinder or the Air

Cylinder pressure system has occurred.
Tube sensor in position 3 is dirty.

Components.
Reset Loader.

10-43

Section 10
Overview
1103
Tube lost moving from position 3 to position 4
Event Type:
SL Fault

A tube was sensed in tube position 3 before the rack advance, but a tube was not sensed in tube position 4 after
the rack advance.
Probable Cause(s)

remove it.

step.
A failure of the Air Cylinder or the Air

Cylinder pressure system has occurred.

Components.
Reset Loader.

10-44
Section 10
1104
Mix zone must be cleared for reset
Event Type:
SL Fault

The sensor system indicates that a tube is present in tube position 4 immediately after the Loader was reset, but
a rack has not yet been pushed into the mix zone.
Probable Cause(s)
A rack remains in the mix zone when the

Loader is reset.
1. Remove the rack from the mix zone.

There is an obstruction at tube position 4 that 1. Remove the Processor Cover.

is activating the sensor.
2. Check for an obstruction at tube position 4 that
is activating the sensor and, if one is found,
remove it.
Loader.

Components.
Reset Loader.

10-45

Section 10
Overview
1105
Excessive cycling
Event Type:
SL Fault

Twenty rack advances have occurred without a tube being sensed in the mix zone or twenty-five rack advances
have occurred after the last tube was processed.
Probable Cause(s)
The System is functioning as intended.
No corrective action is necessary. When you wish to

run additional samples in the Loader, load tubes in
racks and press the keys in the following order:
Clear Fault, Start Loader, Resume Loader.
The rack advance mechanism is not making

contact with the racks.

rack arms from extending and holding the racks
against the loader wall so the racks can engage
with the rack advance mechanism. If an
obstruction is found, remove it.
2. Reset the racks and reset the Loader by pressing
Loader, Resume Loader.
Both tube sensors are dirty.

Components.
Resume Loader.
A failure of the sensor or related electronics,

or loader mechanisms, has occurred.
10-46
Section 10
1106
Unload area full
Event Type:
Information

The unload area contains 5 racks. No corrective action is necessary. When you wish to run additional samples
in the Loader, remove the racks from the unload area and press the Start Loader key.
1107
Unload area hardware malfunction
Event Type:
SL Fault

The sensor system is indicating that the loader rack arms did not fully retract in the unload area.
Probable Cause(s)
One or more racks did not move properly in

the unload area.
1. Check for an obstruction that is preventing rack

movement in the unload area and, if one is
found, remove it.


Customer Service.
10-47

Section 10
Overview
1108
Closed mode needle stuck at home position
Event Type:
SL Fault

The home position for the probe is the uppermost position. The sensor indicates that the needle is in the home
position when the System does not expect the probe to be homed.
Probable Cause(s)
A mechanical problem has prevented the

closed mode needle from leaving the home
position on the aspiration tower.

2. Check for an obstruction with the aspiration
tower that is preventing the closed mode needle
from leaving the home position and, if one is
found, remove it.
Loader.
10-48

has occurred.

Customer Service.
The tower, motor, or related electronics is

defective.
Section 10
1109
Closed mode needle unable to reach home position
Event Type:
SL Fault

The home position for the probe is the uppermost position. The sensor system indicates that the needle is not
in the home position when the system expects the probe to be homed.
Probable Cause(s)
A mechanical problem has prevented the

closed mode needle from leaving the home
position on the aspiration tower.

2. Check for an obstruction with the aspiration
tower that is preventing the closed mode needle
from leaving the home position and, if one is
found, remove it.
Loader.
1111

has occurred.

Customer Service.
The tower, motor, or related electronics is

defective.
Load zone empty
Event Type:
Information

The load zone empty condition is raised when no rack is detected by the barcode reader after a given number
of index cycles.
No corrective action is necessary. When you wish to run samples in the Loader, load tubes in racks and press
the Start Loader key.
10-49

Section 10
Overview
1257
Shear valve position sensor fault
Event Type:
Fatal Fault

Probable Cause(s)
the allotted time.
action.
box.
b. Perform Prime.
Power Off.
10-50

Customer Service.
Section 10
1631
WOC heater temperature out of range
Event Type:
Warning

System detected reagent heater temperature out of specification range.
WOC HEATER ERROR is displayed to the right of the platelet parameter result region in the Run View.
WOC HEATER ERROR is printed on all reports. The invalid numerical results for WBC and Differential are
NOTE: WBC and WOC are astrisked for all cases except for runs with a Specimen Type of Patient and the
CBC + NOC Test Selection, where the WBC value always comes from the NOC.
Probable Cause(s)
WOC heater temperature is sensed as being 1. If using the Loader, reset the racks before
outside of the manufacturers specified range
due to:
1. Ambient temperature below or above
manufacturers specified range.
2. Heater temperature sensor failure.
3. Heater is stuck OFF (low temperature
failure) or ON (high temperature failure).
Power Off.
3. If the message appears repeatedly, contact
10-51

Section 10
Overview
1632
HGB heater temperature out of range
Event Type:
Warning
The Analyzer Status region indicates current status.

System detected reagent heater temperature out of specification range.
HGB HEATER ERROR is displayed to the right of the platelet parameter result region in the Run View.
HGB HEATER ERROR is printed on all reports. The invalid numerical results for WBC (if NOC is chosen),
Differential, HGB, MCH, and MCHC are marked with an asterisk [*]. Review all results marked with an
asterisk. Follow your laboratorys procedures.
Probable Cause(s)

HGB heater temperature is sensed as being
outside of the manufacturers specified range
due to:
2. Run a background count and review results.
1. Heater temperature sensor failure.
Background results must be within acceptable
limits before running controls or Patient
2. Heater is stuck OFF (low temperature
Specimens.
failure) or ON (high temperature failure).
NOTE: Section 5: Operating
Power Off.
10-52
Section 10
1633
Three consecutive WOC Heater Errors
Event Type:
Warning
The Analyzer Status region indicates the current state.

1634
Probable Cause(s)
Three consecutive WOC Heater Error

messages occurred during loader operation.
1. Troubleshoot the WOC heater.
Three consecutive HGB Heater Errors
Event Type:
Warning

1851
Probable Cause(s)
Three consecutive HGB Heater Errors

occurred during loader operation.
1. Troubleshoot the HGB heater.
Database Auto-Backup failure
Event Type:
Warning
The Analyzer Status region indicates the current state. The System halts the automatic backup of database.
1852
Probable Cause(s)
Hard drive Subsystem failure out of hard

drive space.
Database Transaction Log Auto-Backup Failure
Event Type:
Warning
The Analyzer Status region indicates the current state. The System halts the automatic backup of the database
transaction log.
Probable Cause(s)
Hard drive Subsystem failure out of hard

drive space.
10-53

Section 10
Overview
2072
Analyzer initialization failed
Event Type:
Fatal Fault

Probable Cause(s)
The instrument software was unable to

initialize.

action.
box.
b. Perform Prime.
a. If using the Loader, reset the racks before
b. Select File, then Shutdown
c. Select OK to initiate Shutdown.
d. Wait 5-10 seconds after the display turns
Power Off.
10-54
Section 10
2073
Error opening A32MAIN.S
Event Type:
Fatal Fault
NOTE: The Analyzer Status region indicates Fatal Fault.

Probable Cause(s)
The A32MAIN.S software file is missing

after software installation or upgrade.

action.
box.
b. Perform Prime.
Power Off.
A failure in the Analyzer hardware, possibly

related to the HSSL cable, card, or memory,
has occurred.
10-55

Section 10
Overview
2074
Error opening Fsq <name of Fsq>
Event Type:
Fatal Fault

Probable Cause(s)
The allotted time for the flow sequence (Fsq) 1. Review the following recommended corrective
downloading was exceeded.
action.
box.
b. Perform Prime.
Power Off.
Computer hardware component failure or
malfunction.
10-56
Section 10
2075
Unable to open HSSL driver
Event Type:
Fatal Fault

Probable Cause(s)
Unable to open High Speed Serial Link

(HSSL) driver

action.
2. Press the Save button, to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
Power Off.

malfunction.
10-57

Section 10
Overview
2076
HSSL Error
Event Type:
Fatal Fault

Probable Cause(s)
Communication between Analyzer and Data

Module failed.

action.
box.
Power Off.

malfunction.
10-58
Section 10
2077
Flow script timeout <name of fsq>
Event Type:
Fatal Fault

Probable Cause(s)
Flow script did not execute in expected time. 1. Review the following recommended corrective
action.
box.
b. Perform Prime.
6. See Section 5: Operating Instructions,
Subsection: Power On and Power Off.
10-59

Section 10
Overview
2078
Invalid Parameter in Fsq <name of fsq>
Event Type:
Fatal Fault

Size or structure of parameter (e.g., gain) is invalid.
Probable Cause(s)
A software error has occurred.

action.
box.
b. Perform Prime.
Power Off.
10-60
Section 10
2079
Invalid Macro in Fsq <name of fsq>
Event Type:
Fatal Fault

Probable Cause(s)

action.
box.
b. Perform Prime.
Power Off.
10-61

Section 10
Overview
2080
HSSL bad command or command sent at inappropriate time
Event Type:
Fatal Fault

Probable Cause(s)
Data Module and Analyzer did not

communicate properly.

action.
box.
b. Perform Prime.
Power Off.
2081
HSSL bad command or command sent at inappropriate time
Event Type:
Warning

This is a warning that a bad command or a command was sent to the Analyzer at an unexpected time. No
corrective action is necessary.
10-62
Section 10
2082
Message ack timeout on Analyzer
Event Type:
Fatal Fault

Probable Cause(s)
Communication between the Analyzer and

the Data Module did not occur when
expected.

action.
box.
refer to Section 5: Operating Instructions,
Subsection: Power On and Power Off.
Power Off.
10-63

Section 10
Overview
2083
Analyzer monitor (bios) received illegal command
Event Type:
Fatal Fault

This message pertains to a software execution monitor on the Analyzer, not the display screen (LCD).
Probable Cause(s)
During the initialization process, the Data

Module and Analyzer did not communicate
properly.

action.
box.
b. Perform Prime.
Power Off.
10-64
Section 10
2084
Runtime error in Analyzer Module
Event Type:
Fatal Fault

Probable Cause(s)
An illegal software operation was requested

by the Analyzer.

action.
box.
b. Perform Prime.
Power Off.
10-65

Section 10
Overview
2085
DMA controller error during list mode acquisition
Event Type:
Fatal Fault

A direct memory access (DMA) control problem occurred during data acquisition.
Probable Cause(s)
A failure in the Analyzer hardware has

occurred.

action.
box.
b. Perform Prime.
Power Off.
10-66
Section 10
2086
DMA controller setup error
Event Type:
Fatal Fault

A problem occurred during setup of the direct memory access (DMA) controller.
Probable Cause(s)
A failure in the Analyzer hardware has

occurred.

action.
box.
b. Perform Prime.
Power Off.
10-67

Section 10
Overview
2088
Bad checksum in non-volatile RAM
Event Type:
Fatal Fault

Probable Cause(s)
When the system was powered ON, the

Analyzer did not transmit the correct message
action.
to the Data Module.
box.
Power Off.
10-68
Section 10
2089
Incorrect FSQ command on Analyzer
Event Type:
Fatal Fault

Probable Cause(s)

action.
box.
Power Off.
10-69

Section 10
Overview
2090
Sample handler command negatively acknowledged
Event Type:
Fatal Fault

Probable Cause(s)

action.
box.
Power Off.
10-70
Section 10
2091
Flow sequence timeout on Analyzer
Event Type:
Fatal Fault

Probable Cause(s)

action.
box.
Power Off.
10-71

Section 10
Overview
2092
Retransmission error on Analyzer
Event Type:
Fatal Fault

Communication from the Data Module to the Analyzer failed.
Probable Cause(s)
A hardware failure or system error has

occurred.

action.
box.
3. Check the Hssl cable connections.
NOTE: For the location of the Hssl ports,
b. Perform Prime.
Power Off.
10-72
Section 10
2093
<Tower or Loader> transmission failure
Event Type:
Fatal Fault

A transmission acknowledgment failure occurred between the Analyzer and the module that controls the tower
and loader.
Probable Cause(s)
A failure of the electronics or communication 1. Review the following recommended corrective

hardware has occurred.
action.
box.
Power Off.
NOTE: If the message appears
repeatedly, contact Abbott Customer
Service.
10-73

Section 10
Overview
2094
<Tower or Loader> communication failure
Event Type:
Fatal Fault

A communication failure occurred between the Analyzer and the module that controls the tower and loader.
Probable Cause(s)
A communication timing or handshake error

has occurred.

action.
box.
Power Off.
10-74
Section 10
2095
<Tower or Loader> direct command parameter error
Event Type:
Fatal Fault

The Analyzer command given to the module that controls the tower and loader is invalid.
Probable Cause(s)

action.
box.
Power Off.
10-75

Section 10
Overview
2096
<Tower or Loader> motor command timing error
Event Type:
SL Fault

A motor in the Loader was busy (e.g., in motion) when a command was received and could not respond.
Probable Cause(s)
A mechanical problem in the aspiration tower 1. Remove the Processor Cover.

or Loader has occurred.
2. Check for an obstruction in the aspiration tower
or Loader and remove it.
keys in order: Clear Fault, Start Loader, Reset
Loader.
2097
<Tower or Loader> invalid direct command
Event Type:
Fatal Fault

Probable Cause(s)

action.
box.
Power Off.
10-76
Section 10
2098
<Tower or Loader> invalid process command
Event Type:
Fatal Fault

Probable Cause(s)

action.
box.
Power Off.
10-77

Section 10
Overview
2099
Event Type:
Fatal Fault

Probable Cause(s)

action.
box.
b. Perform Prime.
Power Off.
10-78
Section 10
2100
HSSL timeout
Event Type:
Fatal Fault

Probable Cause(s)
Communication timed out between Analyzer 1. Review the following recommended corrective
and Data Module.
action.
box.
Power Off.
10-79

Section 10
Overview
2237
Event Type:
SL Fault

The rack bar code label (the first label on the rack) could not be read. This label has a two-digit rack number.
Probable Cause(s)
The window on the Bar Code Reader is dirty. 1. Review the following recommended corrective
action.
step.
3. Press Clear Fault to close the SIM dialog box.
4. Select Maintenance then As-Needed tab.
a. Perform Clean Bar Code Reader.
b. Reset the Loader by pressing the following
keys in order: Start Loader, Reset Loader.
The tube position bar code label is scuffed or 1. Clean or replace the tube position bar code
dirty.
label.
The rack from the mix zone was not removed Reset the racks, then reset the Loader by pressing
and reset before the Reset Loader key was
pressed.
The Bar Code Reader cable has been
disconnected, or the Bar Code Reader or
related electronics has failed.
10-80

Customer Service.
Section 10
2238
Tube position bar code read failure
Event Type:
SL Fault

A tube position bar code label could not be read.
Probable Cause(s)
The window on the Bar Code Reader is dirty. 1. Review the following recommended corrective
action.
step.
4. Select Maintenance then As-Needed tab.
a. Perform Clean Bar Code Reader
Window.
b. Reset the Loader by pressing the following
keys in order: Start Loader, Reset Loader.
The tube position bar code label is scuffed or 1. Clean or replace the tube position bar code
dirty.
label.
The Bar Code Reader cable has been
disconnected, or the Bar Code Reader or
related electronics has failed.

Customer Service.
10-81

Section 10
Overview
2442
Unable to Open Communication
Event Type:
Warning
2443
Probable Cause(s)
Serial port hardware failure.
1. Check cabling. Check configuration of comm

port.
LIS Transmit Err: Invalid specid
Event Type:
Warning
2444
Probable Cause(s)
Invalid specimen ID in a record for which a

manual transmit was initiated.
1. Ensure that specimen ID is valid. See section on

Valid Specimen ID.
LIS Transmit Err: Already on LIS queue
Event Type:
Warning
10-82
Probable Cause(s)
A record for which a manual transmit was

initiated is already queued for transmission.
1. Only one instance of a specimen ID is allowed

on the queue at a time. Check the cause for two
orders with the same specimen ID.
Section 11 Quality Control
Section 11
Quality Control
Overview
Quality control on the CELL-DYN Ruby involves monitoring control results,
whole blood patient data, and operator initiated background count data. Quality
Control ID (QCID) files and programs designed especially for the
CELL-DYN Ruby facilitate this monitoring. The System can automatically
evaluate results and display messages for the operator to review data and confirm
results. The quality control programs on the CELL-DYN Ruby help assess
precision and accuracy, identify shifts and trends, and determine the nature and
cause of errors.
The following programs are available for monitoring daily quality control using
commercial and whole blood patient controls:
QCID File Data and Statistics
Westgard Rules
Levey-Jennings Graphs
The following program is available for System performance monitoring during
routine analysis of patient specimens:
Moving Average Programs (including X-B) and associated Levey-Jennings
Graphs
The CELL-DYN Ruby software programs listed above are referred to as internal
quality control programs because they involve instruments and materials within a
laboratory. The System is shipped with default settings for these programs to
enable a laboratory to use them immediately.
Abbott recommends that internal quality control programs be left on and run
initially with the default settings until your laboratory has had a chance to establish
means and ranges based on your facilitys population. Programs can then be
optimized and customized over the next few months. Suggestions for optimization
and customization are provided with the descriptions and procedures for each
program.
External quality control programs use resources available outside a laboratory to
assess System performance. These programs assist in the peer review process that
allows a laboratory to compare its performance with that of other laboratories. For
example, in Germany and the USA, laboratories are required to participate in
proficiency testing. Proficiency testing provides independent validation of a
laboratorys internal QC program.
For more information about external quality control programs, contact your
Country Service and Support Center.
11-1
Quality Control
Section 11
Overview
When to Run QC
The frequency of quality control runs should be determined by each laboratory.
This may be specified by the regulatory agencies governing the laboratory. Quality
Control specimens should be run and results confirmed to be within acceptable
limits prior to reporting patient results. Controls should also be run:
After a reagent lot number change
After maintenance, component replacement, or a field service action
After a software change
Following calibration
According to your laboratorys quality control program
According to regulatory requirements
11-2
Section 11
Quality Control
QC Methods
The following programs are for monitoring daily quality control using commercial
and whole blood patient controls:
QCID File Data and Statistics
Westgard Rules
The following program is available for System performance monitoring during
routine analysis of patient specimens:
Moving Average Programs (including X-B) and associated Levey-Jennings
Graphs
Control Material
Commercial controls contain fixed cells and are assayed by the manufacturer to
determine target ranges. Refer to Appendix A: Parts and Accessories for the list
of available commercial control material that can be used for monitoring the CBC
(including differential) and reticulocyte parameters. MCHC Flag will not trigger
on QC-Commercial Control type.
NOTE: Flags may occur with control materials and should be disregarded.
Whole Blood patient controls are fresh specimens selected from normal patients
and tested by the laboratory to establish target ranges. They are an accurate and
cost-effective means of evaluating the performance of the CELL-DYN Ruby.
11-3
Quality Control
Section 11
QC Methods
NOTES
11-4
Section 11
Quality Control
Quality Control Procedures

Guidelines for Running Controls
Day-to-day verification of System calibration is performed using
CELL-DYN Control products, unless the laboratory has an alternative
approach, such as the equivalent quality control system recognized by the US
Centers for Medicare and Medicaid Services. In such cases, Abbott does not
require daily stabilized controls.
Prior to running patient specimens, run controls according to the laboratorys
procedures.
Run controls for each measured parameter in the same manner as patient
specimens.
Verify that control results are within the laboratorys acceptable limits and
review the data for shifts or trends.
If QC results fall outside the laboratorys acceptable limits, see Section 10:
Troubleshooting and Diagnostics or try another tube from the same lot of
control material. If the problem persists, contact your Country Service and
Support Center.
Do not report patient results if QC results fall outside the laboratorys
acceptable limits.
Verify the control file being used is the correct file in which means and limits
are updated.
Print and/or archive the information in each QCID File at intervals specified
in your laboratorys procedures.
For efficiency in running controls in the Closed Mode, Q Label Bar Codes
can be used on the tubes to identify them as controls and direct the results to
the appropriate QCID File. Q Labels are available as optional accessories.
For more information, refer to Appendix A: Parts and Accessories.
Control Material Guidelines

Use the following guidelines for proper handling of control material:
Check the condition of incoming control material. Be sure the tubes are at the
proper temperature and are not leaking. Check for gross hemolysis.
Check the shelf-life and open-tube stability dating. Do not use products
longer than recommended by the manufacturer, or the results may be
compromised.
Always mix and handle commercial control materials according to the
directions given on the package insert. Proper mixing is essential for accurate
results.
11-5
Quality Control
Section 11
Never subject controls to excessive cold, heat, or agitation. Store controls at

recommended temperatures; if storing controls inside a refrigerator, place in
a central location. Do not store control or calibrator material in the
refrigerator door.
Assay Verification Procedure

New control material lots should be analyzed in parallel with current lots prior to
their expiration dates. To accomplish the transition to a new lot of control material,
follow your laboratorys protocol or proceed as follows:
1. Create Low, Normal, and High QCID files for the new lot. Refer to
Subsection: QCID File Setup.
2. Verify the new control lot by running each level of control three times in its
respective file to ensure that the mean of all three runs is within the range
shown on the assay sheet.
3. Run the new controls twice a day for five days.
4. Use the mean of the 10 runs to verify that the new lot yields expected results.
5. Compare the mean to the range specified on the assay sheet. The mean should
fall within the range specified by the manufacturer in the package insert.
6. If the calculated mean falls within the range specified on the assay sheet, use
it in place of the manufacturers stated mean. (For details on updating means,
refer to Subsection: QCID File Setup.)
7. When results for any parameter(s) are flagged (outside of laboratory-defined
limits or reportable range), follow your laboratorys procedure for out-ofrange results.
11-6
Section 11
Quality Control
Establishing the Mean

Three QCID files should be set up for the new lot number for each level of control:
Low, Normal, and High. If desired, the QCID files can then be used to run the
controls for the remainder of the dating period. It is not necessary to create another
file.
The expected ranges published by manufacturers are generally too broad for
effective Quality Control1. Each office or laboratory must establish its own ranges.
These ranges may be determined by evaluating data from a three to six month
period (data from the interlaboratory CELL-DYN eQC Program can be used) for a
particular level of control.
Individual SD (standard deviation) values can be averaged as follows:
Average SD =
(N1 x SD12) + (N2 x SD22) + ... (Ni x SDi2)

(N1 + N2 + ...Ni) - 1
number of values in a group
SD
Standard Deviation of the values in that group
the last group of values
The resulting long-term instrument standard deviation and the laboratoryestablished mean for each lot number can be used to monitor overall instrument
performance.
11-7
Quality Control
Section 11
NOTES
11-8
Section 11
Quality Control
Quality Control
QC View
This section discusses the QC View, which is selected from the tool bar. The QC
View stores all Quality Control ID (QCID) result data and the control
demographic information in a log format on the CELL-DYN Ruby. Their Datalog
view sequence number displays the QC run results chronologically when results
are available for each QCID specimen run. The QC run view that contains the
scatterplot and histogram details can be viewed either by using the mouse to
highlight and double click on the record or by selecting the F7 View QC Spec.
See also Subsection: View QC Spec.
The options used to set up the QCID files are available from Setup, QCID Setup
menu bar where the Operator can edit the lot number and expiration date for the
selected QCID files, enter means and range values for each parameter specified on
screen, and select which Westgard Rules will be applied to Quality Control results.
When reviewing QCID L-J Plots or QCID Data, using F6 View QC Setup can
also access the QCID Setup information dialog box. Parameter results for any
control run that fall outside the entered limits are displayed in color (purple for outof- range high and yellow for out-of-range low) and underlined on the printout to
alert the Operator. See also Subsection: QCID File Setup.
11-9
Quality Control
Section 11
Quality Control
Program Operation
QCID Files
QC result data and statistics are stored in QCID Files. Three QCID subtypes
available on the CELL-DYN Ruby are:
Commercial
Whole Blood
Background and RETC_Background
NOTE: QC limits and control data information are not customizable for
QCID subtype Background and RETC_Background.
A QCID File is assigned to each level of
commercial control and each whole blood patient
control. There is a maximum of 500 QCID files
that can be set up and created on the System. The
QCID Lookup icon
, located in the Next
Open Tube Entry (NOTE) region can be
selected to display the current listing of QC
Specimen IDs (QCID) files set up on the System.
NOTE: When using this icon, the list of QCID files associated with the
reticulocyte parameters can only be displayed when the System is ready
to run the Open Mode Reticulocyte Method, RETIC test selection.
QCID specimen records can be moved from one QCID file to another, allowing
users to clear records from the initial QCID file. At the end-of-the month, this
allows users to compare current month results with prior month results. This
feature also allows users to use a QCID file for different short-term collections of
records, as well as re-use a QCID file for one-time collection of records.
A QCID file (for QC Whole Blood or QC Commercial) can be manually deleted.
Refer to Subsection: QCID File Deletion. QCIDs can also be deleted from the QC
View and QCID View. Refer to Subsection: Scrolling Through the QC View and
Subsection: QCID Data respectively.
QCID files are automatically deleted when:
There are no sample records for the QCID in the QC View or in the Datalog
view and that QCID setup is more than 1 month old.
The last sample run into the file for a QCID subtype of Commercial control
in the QC View or in the Datalog view is greater than 180 days old.
The last sample run into the file for a QCID subtype of Whole Blood control
in the QC View or in the Datalog view is greater than 90 days old.
The last sample run into the file for a QCID subtype of Background and
RETC_Background in the QC View or in the Datalog view is greater than 90
days old.
11-10
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Quality Control
QCID file data can also be downloaded to a floppy diskette for use with the
interlaboratory QC monitoring CELL-DYN eQC program that compares
instrument performance between different labs, allowing you to determine the
reliability of your laboratory testing. Refer to Subsection: Download QCID Data.
QCID file summary data currently stored in each file can be displayed and printed.
Each time a QC specimen is run, the number of specimens, mean, coefficient of
variation, and standard deviation for each parameter displayed are calculated and
updated automatically in each file. The Operator can, at any time, elect to reject any
run with flagged (outside entered limits) data from this calculation or move any
specimen run from one QCID file to another QCID file. Refer to Subsection:
Rejecting/Accepting Specimens and Subsection: Edit QC Specimens.
Westgard Rules status can be applied to the analysis of QCID specimen results with
Westgard Rule warnings viewable in the QCID file summary data on screen and
printed on reports. The Levey-Jennings graphs for QCID file results can be printed.
Refer to Subsection: Analyzing QCID File Results later in this section.
11-11
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Quality Control
NOTES
11-12
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Quality Control
Quality Control Software

The QC View allows the Operator to perform the following functions:
Display the parameter-specific result data for each QCID specimen record in
the QC View log
Display the QC information data for each QCID specimen record in the QC
View log
Display the run view for each QCID specimen record in the QC View log
Select a QCID specimen record and view the QCID file Levey-Jennings
graphs and data
View the QCID file means and limits
Accept and reject QCID specimen results from the QCID file
Move QCID specimens from one QCID file to another
Display and print Levey-Jennings graphs
Upload or download QCID file data from or to floppy diskette
Open the QCID Setup dialog box
View and print the Moving Average Programs Levey-Jennings graphs and
closed batch data
Delete QCID files and QCID specimen records
Locate (find) record Run View
A brief description of each view and its function follows.
11-13
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Section 11
Using QC View
Main QC View
Tab Views
The QC View consists of the following 7 tab views:
CBC
DIFF
RBC
PLT
RETC
DIFF ABS
QC Info
The following column headings are
common to all 7 tab views:
Seq# - Datalog sequence
number
Spec ID QCID Specimen ID number
M - Mode: O = Open Mode or C = Closed Mode
Date Run date
11-14
Section 11
Quality Control
Time Run time

OPID - Operator ID at the time the QCID specimen was run
For details on customizing the tab view while in the QC View, see Section 2:
Installation Procedures and Special Requirements, Subsection: Customize Data
View.
The QC Info tab view contains additional column headings:
Spec Type - QC-Commercial, QC-Whole Blood, QC Background, or QC
RETC_Background
Lot Number QCID File commercial control lot number
Exp Date QCID File commercial control expiration date
Org Spec ID QCID File whole blood original specimen ID number
Comment
The text
entered in the
QCID Setup
Control Data
Comments field.
Scrolling Through the QC View

Each screen display (page) contains up to 34 specimens.
Use the screen navigation keys to scroll (horizontally or vertically) through the
complete list of parameter tab views for all specimens displayed or use the mouse
and click on the tab to display a different parameter view.
11-15
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Section 11
Table 11.1
Screen Navigation Bar and Buttons

Navigation
Bar
Buttons
Description
Scrolls to desired page; lists current page
and total number of pages
Moves to the view of the previously

displayed specimen
Moves to the page previously viewed
Moves to the beginning of the log view
Moves to the view of the next specimen

in the display view
Moves to the next page in the display
view
Moves to the end of the log view
Function Keys
When QC View is selected from the tool bar the following function keys are
displayed for all tab views:
F1
Print
F2
F3
Transmit Find/Filter
F4
Edit
F5
Moving Average
F7
View
QC Spec
F8
QCID
L-J Plots
F1Print
F2Transmit
11-16
Section 11
Quality Control
F3Find/Filter
F4Edit
F5Moving Average
F7View QC Spec
F8QC L-J Plots
Table 11.2
QC View Function Keys
Function key ...
F1Print
F2Transmit
F3Find/Filter
F4Edit
F5Moving
Average
What it does ...

Prints all records or the
selected records in the QC
View.
Comments
Print Summary View or Print
Single Specimen View
report for each record in
selected range.
This feature is currently not

available.
Opens the Find/Filter dialog
box which has two tabs
Find/Filter
Advanced Find/Filter
Both are used to locate a
record by entering
information in the dialog box
fields. Selecting the Find
button displays the QC View
screen. If the record is not
found in the QC View, the
Bulletin line displays the
message: NO ENTRY
FOUND.
When Find/Filter is used on

a changed demographic
(Lot #, Exp date, Org Spec
ID, Draw or Test) only the
records created under the
changed demographic will
be found. However, when
using Find/Filter on the
original demographic the
operator will see the records
for the original demographic
in the Find/Filter results
Dialog box but the display
and/or print records will only
be the changed
demographic records.
Opens the QCID Edit dialog

box to change the
highlighted QCID records
QCID file specimen ID
number
Displays the System Moving
Average Programs
Tabs and Function keys will

change in this view. See
also Subsection: Moving
Average Programs.
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Section 11
Table 11.2
QC View Function Keys (Continued)
F7View QC
Spec
F8QCID L-J
Plots
Displays the Run View for

the highlighted QCID record

also Subsection: Moving
Average Programs.
Displays the QCID file

Levey-Jennings view for the
highlighted QCID record.

also Subsection: QCID L-J
Plots.
QCID Deletion
QCID Deletion can be used to delete QC Whole Blood or QC Commercial QCIDs.
Deletion can be done from the QC View screen.
PROCEDURE: TO DELETE QC WHOLE BLOOD OR QC COMMERCIAL QCIDS
1. Select the QCID to delete.
2. Right click and select deletion action. For example, select Delete QCID and
QC Log records (the one high-lighted and all other records for that QCID
plus QCID Setup data)
A confirmation message displays. Select Yes.
Or you can select Delete QC log records for QCID (the one high-lighted and all
other records for that QCID.
11-18
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Quality Control
After a QCID has been deleted (either QC Whole Blood or QC Commercial), the
data log displays:
Draw Date: <blank>
Draw Time: <blank>
Lot Number: <blank>
Parameter set: 1
11-19
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Section 11
View QC Spec
Chartable tab
Lab tab
Graphs tab
Selecting the F7View QC Spec function key from the QC View displays three
tabs Chartable, Lab, Graphs which reveal the specimen information for the
selected record. The following function keys are displayed.
Table 11.3
Function Keys View QC Spec
Function key ...

F1Print
F3Find/Filter
11-20
What it does ...
Comments
Prints the Run View for the tab

selected.
used to locate a particular record
Run view by entering information.
When the Find button is selected,
and the software finds a match, the
QC View updates and displays the
Run view with the record it found. If
the record is not found in the QC
View, the Bulletin line displays the
message: NO ENTRY FOUND in the
Find/Filter dialog box.
Section 11
Quality Control
Table 11.3
Function Keys View QC Spec (Continued)
Function key ...
What it does ...
F4Edit
Opens the QCID Edit dialog box to

change the highlighted QCID
records QCID file specimen ID
number
F7Previous
Specimen
Displays the Run View results for the

sequence number preceding the one
currently displayed without returning
to the main QC View
F8Next
Specimen
Comments
Displays the Run View results for

the next specimen in the QCID file
without returning to the main QC
View
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Section 11
QCID L-J Plots

The Levey-Jennings View allows the user to do the following tasks:
Print the L-J plots
Vertically scroll through the Levey-Jennings View to access all L-J plots
View L-J Plot data that includes the batch number and data value
When F8QC L-J Plots is selected from QC View to display the QCID file LeveyJennings view for the highlighted QCID record, the following function keys are
displayed in all tab views.
Table 11.4
Function Keys QCID File Levey-Jennings View
Function key ...
What it does ...
F1Print
Prints the Levey-Jennings Plot for

the QCID file tab view selected.
F5Download
QCID Data
F6View QC
Setup
F8QCID Data
11-22
Comments
Opens the Download QCID Data

dialog box save QCID file data to
media.
See also
Subsection:
Download QCID
Data
Displays the QCID Setup: View

dialog box.
See also
Subsection: QCID
File Setup
Displays the QCID file data view

for the highlighted QCID record.
Function keys change

in this view.
Section 11
Quality Control
QCID Data
When F8QCID Data is selected from QCID L-J Plot view to display the QCID
View (QCID file data) for the highlighted QCID record, the following function
keys are displayed for all tab views.
11-23
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Section 11
Table 11.5
Function Keys QCID Data Dialog Box
Function key ...
What it does ...
F1Print
Prints all records or the selected

records in the QCID File Data view.
F2Transmit
This feature is currently not

available.
F3Find/Filter

used to locate a particular record
Run view by entering information.
When the FIND button is selected,
and the software finds a match, the
QC View updates and displays the
Run view with the record it found.
If the record is not found in the QCID
File Data view, the Bulletin line
displays the message: No records
found for the specified match
criteria in the Find/Filter dialog
box.
F4Edit
Opens the QCID Edit dialog box to

change the highlighted QCID
records QCID file specimen ID
number.
F5
Reject/Accept
Rejects or Accepts the highlighted

data; when Reject is selected for an
item, the F5 function key appears as
F5Accept
F6View QC
Setup
F7View QC
Spec
F8QCID L-J
Plots
11-24
Comments
Displays the QCID Setup: View

dialog box.
See also
Subsection: QCID
File Setup
Displays the Run View for the

highlighted QCID record.
Tabs and Function

keys will change in
this view.
Displays the QCID file LeveyJennings view for the highlighted

QCID record.
Tabs and Function

keys will change in
this view.
Section 11
Quality Control
QCID Deletion
QCID Deletion can be used to delete QC Whole Blood or QC Commercial QCIDs.
PROCEDURE: TO DELETE QC WHOLE BLOOD OR QC COMMERCIAL QCIDS
1. From the QCID L-J Plot view, select F8-QCID Data. The QCID file data is
displayed for the highlighted record.
2. Select the QCID to delete.
3. Right click and select deletion action. For example, select Delete QCID and
QC Log records (for the high-lighted QCID and all other records for that
QCID plus QCID Setup data).
NOTE: If this option is selected, the screen will refresh and return to the QC View
after the deletion.
Or you can select Delete QC Log records for QCID (the one high-lighted and all
other records for that QCID).
11-25
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Section 11
data log displays:
Draw Date: <blank>
Draw Time: <blank>
Lot Number: <blank>
Parameter set: 1
11-26
Section 11
Quality Control
Download QCID Data
F5Download QCID Data can be selected from either the QCID L-J Plot or the
QCID Data view to display the Download QCID Data dialog box.
11-27
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Section 11
Table 11.6
Field QC Download Dialog Box
Field
QCID Details
+
Table 11.7
Description
Lists details of data being downloaded
Instructions for downloading data
Buttons QC Download Dialog Box
Buttons
Description
OK
Advances to the next step in the downloading process
Cancel
View QC Setup
Control Data page
QC Limits page
Westgard page
11-28
Section 11
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F6View QC Setup can be selected from either the QCID L-J Plot or the QCID
Data view to display the QCID Setup: View dialog box. The QCID Setup: View
has three tabs:
Control Data
QC Limits
Westgard
Each dialog box and the qualities specific to the dialog box are explained in each
section. The buttons which are common to each dialog box are explained in QC
Setup Buttons.
Control Data
Control Data page, Control Type: Background
Control Data page,

Control Type: Whole Blood
Control Data page,

Control Type:
Commercial
The Control Data information which is displayed is based on the control type for
the selected QCID file.
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Quality Control
Section 11
Table 11.8
Fields QCID Setup: View, Control Data Dialog Box
Field
QCID
Description
Select the name using the pull-down menu
Control Data
Information
Indicates the type of control: Commercial, Whole Blood,

Background
Comments
Optional operator entered comments in QCID file Setup
QC Limits
QC Limits are established by the
laboratory and used to monitor the
system according to laboratory
requirements.
Table 11.9
QC Limits page
Fields QCID Setup: View, QC Limits Dialog Box

Field
QCID
Standard Deviations
Limits [+/-]
Description
Assigned name
Select QC Limit setting to: N/A, 2SD, or 3SD. 2SD or
3SD must be selected to enable Westgard Rules.
Displays the parameter specific means, limits, and units
set up for the selected QCID file
Westgard
A multi-rule system applied to the data in each of the QC Files to detect drift and
imprecision and to detect systematic or random error.
11-30
Section 11
Quality Control
Table 11.10 Fields QCID Setup: View, Westgard Dialog Box

Field
QCID
Description
Quality Control ID
Rule
Westgard
Term
Description
1 sub 2S
Value outside 2SD
1 sub 3S
Value outside 3SD
2 sub 2S
Two consecutive values outside the same 2SD
R sub 4S
The range between two consecutive values is greater

than 4SD
2 of 3 sub 2S Two of three consecutive values outside the same 2SD
4 sub 1S
Four consecutive values outside the same 1SD
10x
Ten consecutive values on the same side of the mean
QC Setup Buttons
Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box
Buttons
Description
Update
Mean/Limits [+/-]
Opens the Update Details dialog box when editing or

creating a QCID file
Print
Prints the control data information, QC Limit, and

Westgard Rules for the selected QCID file
Opens the QCID Setup: Basics dialog box to edit a
QCID file
Edit
11-31
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Section 11
Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box (Continued)
Buttons
Description
Select the Continue button to open the QCID Setup:
Edit dialog box to edit Control Data, QC Limits, and
Westgard Rules
Control Data page, Control Type: Whole Blood
Control Data page,

Control Type:
Commercial
Edit
11-32
Section 11
Quality Control
Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box (Continued)
Buttons
Description
NOTE: Background and RETC_Background QC Limits
cannot be edited
QC Limits page, QCID: RETC_Background
QC Limits page,
QCID:
Background
Create
Opens the QCID Setup: Basics dialog box to create a

new QCID file. See Subsection: QCID File Setup
Delete
Opens the Delete QCID and/or QC Log records

dialog box.
Close
Closes the dialog box.
11-33
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Section 11
Moving Average View

.
Moving Average View, X-B page
Moving Average
View, X-B page
displaying LeveyJennings graphs
11-34
Section 11
Quality Control
When F5Moving Average is selected from QC View to display the Moving

Average Programs: X-B, WBC, RBC/PLT, and RETC, the following function
keys are available for all tab views.
Table 11.12 Function Keys QC Moving Average View
Function Key
What it does
F1-Print
Prints records in the Moving

Average view: all or selected
records.
F6-Selected Batch
Data
Displays batch data for each run

in a selected batch.
F7-Current Batch
Data
Displays the batch data for each

run in the current batch before
and after closing the batch.
F8-Closed
Batches
Displays closed batch data.
Comments
It is suggested to
customize and
remove headings in
the WBC and RBC
tab view in order for
the print feature to
apply. See
Subsection:
Printing Moving
Average Programs
Information
NOTE: A Batch consists of 20 runs.The current Moving Average displays the

most recent 120 batches.
11-35
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Section 11
Moving Average Levey Jennings View

From Moving Average View, select the F8-Levey Jennings function key.
When F8-Levey Jennings is selected from the Moving Average View, the
following function keys are available from all tabs.
Table 11.13 Function Keys-Levey Jennings View
Function Key
11-36
What it does
Comments
F1-Print
Prints all records in the Levey

Jennings View.
F6-Selected Batch
Data
Displays batch data for each run

in a selected batch.
F7-Current Batch
Data

F8-Closed
Batches
Displays the closed batch data in

a selected batch.
Section 11
Quality Control
When F6-Selected Batch Data is selected from the Levey Jennings View, the
following function keys are available from all tabs.
Table 11.14 Function Keys-Selected Batch Data View
Function Key
What it does
F1-Print
Prints all records in the selected

view.
F7-Current Batch
Data

F8-Closed
Batches
Displays the closed batch data in

a selected batch.
Comments
From the Selected Batch Data View, users can select and view:
Current Batch Data
Closed Batches
11-37
Quality Control
11-38
Section 11
Section 11
Quality Control
Quality Control Software Setup

QCID File Setup
Control
QC Limits
Westgard
Commercial
PROCEDURE: CREATING A COMMERCIAL QUALITY CONTROL ID (QCID)
1. Select Setup from the menu bar and QCID Setup from the pull-down menu.
The QCID Status: View dialog box opens (default view displays QCID:
Background).
11-39
Quality Control
Section 11
Table 11.15 Field QCID Setup: View Dialog Box

Field
QCID
Control Type
Test Selection
Description
Quality Control ID
Type of control used: Commercial, Whole Blood,
Background
CBC, CBC+NOC, etc.
Param Set
Select 1 through 8 from the pull-down menu
Comments
Optional operator-entered comment
Table 11.16 Buttons QCID Setup: View Dialog Box

Buttons
Description
Edit
Opens the QCID Setup: Basics dialog box
Create
Delete

dialog box.
Close
2. Select Create and the QCID Setup: Basics dialog box opens.
Table 11.17 Field QCID Setup: Basics Dialog Box

Field
New QCID
Control Type
11-40
Description
New QCID
Select from the pull-down menu: Commercial
Section 11
Quality Control
Table 11.18 Buttons QCID Setup: Basics Dialog Box

Buttons
Continue
Cancel
Description
Opens the QCID Setup: Create New dialog box
3. Enter the new Quality Control ID or scan the bar code (if one is present) in
the New QCID field.
NOTE: If entering the QCID using a keyboard, ensure that the first
character is a tilda, ~.
NOTE: Ensure that CAPS Lock on the keyboard is OFF when using the
Hand-Held Bar Code Reader.
4. Select the control type from the pull-down menu in the control field.
5. To access the QC assay values, go to the www.abbottdiagnostics.com.
Contact your Country Service and Support Center for detail.
A. To upload control assay values from website:
a. From lab computer, format the USB flash memory by clicking on Start
(lower left of computer screen), and selecting Programs, Accessories,
Windows Explorer, Computer, then right click on the drive containing
the USB flash memory and select Format. The screen will appear as
below. Make sure the format settings for File system are selected as
identified below.
NOTE: FAT is equivalent to FAT16
b. Click on the Start button to format USB flash memory.

c. Right click on the interested Assay lot number to download and select
Save Target As or similar to save to formatted USB flash memory.
11-41
Quality Control
Section 11
d. Insert USB flash memory to Ruby.

e. Click the Browse button and Cancel to message Place a disk into drive
A; to go to the Ruby Data Station desktop.
f. Select My Computer and locate Removable Disk drive to open.
g. Select the file- Low, Normal, or High.
h. Select Open or OK to close Browser
i. Proceed to the next step.
B. To upload control assay values from the disk:
a. Confirm that the control name, lot number and expiration date on the disk
label are correct for the assay values to be loaded.
b. Insert the floppy disk into the drive.
c. Click the Browse button and navigate to the floppy disk drive.
d. Select the file - Low, Normal, or High.
e. Select Open or OK to close the Browser.
f. Proceed to the next step.
IMPORTANT: The values on the control disk are manufacturers limits
and are not intended to be used as 2SD or 3SD ranges for your laboratory.
NOTE: To create a QCID without using an assay disk, deselect the
checkbox Upload from commercial assay disk and proceed to
step 5.
3. Click Continue and the QCID Setup: Create New dialog box opens with
the Control Data tab as the default.
Bulletin message displays

until the QC Limits Standard
Deviation is set at 2SD or
3SD
11-42
Section 11
Quality Control
Table 11.19 Field QCID Setup: Create New, Control Data Dialog Box
Field
Description
QCID
Assigned QCID
Control Type
Indicates the type of control selected in the Basics dialog

box: Commercial
Lot number
Enter lot number from the assay sheet
Expiration Date
Enter a valid expiration date from the tube
Test Section
Type of test selected from pull-down menu: CBC + NOC

or RETIC
Param Set
Set from 1 through 8, from pull-down menu
Control Brand
Select from the pull-down menu, N/A or select a product
Level
Select from the pull-down menu, one of the following: I, II,

III, Low, High, Normal
Comments:
Optional operator-entered comments
Table 11.20 Buttons QCID Setup: Create New, Control Data Dialog Box
Buttons
Description
Reset All
If the Reset All button is selected (before the Finish button

is selected), any changes made to the information in the
QCID setup will reset all three pages back to their original
content when the dialog box was first opened to edit.
Finish
Selecting before all the info is entered gives a message

Becomes active once all the text is entered
Once all text is entered, selecting Finish ends the
Create New process and changes are made through
Edit
Cancel
Returns to QCID Setup: View without saving any

information entered
4. Select the QC Limits tab and the QC Limits page opens.

5. Enter or confirm assay values:
11-43
Quality Control
Section 11
a. If assay values were uploaded from a disk use the control assay sheet to
confirm the values displayed on the screen are correct for the appropriate
level.
Remove the disk and store it in a safe location. Discard the disk when the
lot has expired.
b. If an assay disk was not used, enter the control assay values using the
control assay sheet.
NOTE: If a mean/limit combination is entered that causes the lower limit to be
less than zero, the lower limit will be automatically set to zero in the QC
limits tab and the QC data view.
The QCID L-J Plots will display the actual range entered.
.
Table 11.21 Field QCID Setup: Create New, QC Limits Dialog Box
Field
QCID
Standard
Deviation N/A
Limits [+/-]
11-44
Description
Quality Control ID
N/A, not applying a standard deviation.
NOTE: 2SD or 3SD must be selected to enable the
Westgard rules.
Displays the parameter-specific means, limits, and units
set up for the QCID file.
Section 11
Quality Control
Table 11.22 Buttons QCID Setup: Create New, QC Limits Dialog Box
Buttons
Description
Update Means/
Limits (+/-)
Opens the Update Details dialog box to update means,

limits, or both means and limits from existing QCID
specimens, QCID file, or retrieve from file.
Print
Reset All
Not available during create or edit. Only available in

QCID Setup: View.
If the Reset All button is selected (before the Finish
button is selected), any changes made to the information
in the QCID setup will reset all three pages back to their
original content when the dialog box was first opened to
edit.
Finish
Accepts the data and any changes and returns to the

QCID Setup: View dialog box.
Cancel
Returns to the QCID Setup: View dialog box.
c. To update existing means and/or limits, select Update Mean/Limits

(+/-) and the Update Details dialog box opens.
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Quality Control
Section 11
Table 11.23 Field Means and Limits [+/-] Update Details Dialog Box
Field
Description
What to update
Select Means, Limits [+/-], or both Means and Limits

[+/-] radio button.
Standard Deviation
Select N/A, not applying a standard deviation, or

2SD, or 3SD.
1.
2.
Source
3.
Select updates using existing QCID specimens

Update by copying from an existing QCID.
Select from the pull-down menu.
Update by uploading user created limits to the
QCID file. See the following procedure:
Retrieving From User Created Limits File.
Table 11.24 Buttons Update Details Dialog Box

Buttons
OK
Cancel
11-46
Description
Updates from selected source
Section 11
Quality Control
PROCEDURE: RETRIEVING FROM USER CREATED LIMITS FILE

NOTE: User created limits files must be in the following format to upload to a
QCID:
Low level:
userlow.dat
Normal level: usernormal.dat
High level:
userhigh.dat
a. Select Retrieve from User Created Limits File and the Update Details
dialog box opens a Browse field. Select Browse. The Insert Disk dialog
box appears.
b. Insert the floppy disk into the drive. If not using a floppy disk select
Cancel.
c. The Browse for Folder window appears. Select the target location and
click Open.
d. Select the file to upload.
e. Select Open to close the Browser.
f. Proceed to the next step.
11-47
Quality Control
Section 11
6. Click OK and the QC Limits dialog tab opens.
NOTE: At the bottom of the dialog box: ! Means and/or limits (+/-) have
been updated.
7. Confirm that the assay values displayed on screen are correct for the
appropriate level.
8. Remove media and store it in a safe place in case it is needed to reload data
for this control lot.
11-48
Section 11
Quality Control
Table 11.25 Field QCID Setup: Create New, Westgard Dialog Box
Field
QCID
Westgard Rules
Description
Quality Control ID
Rule
Westgard
Term
Description
1 sub 2S
Value outside 2SD
1 sub 3S
Value outside 3SD
2 sub 2S
Two consecutive values outside the same

2SD
R sub 4S
The range between two consecutive values

is greater than 4SD
2 of 3 sub 2S
Two of three consecutive values outside the

same 2SD
4 sub 1S
Four consecutive values outside the same

1SD
10x
Ten consecutive values on the same side of

the mean
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Quality Control
Section 11
Table 11.26 Buttons QCID Setup: Create New, Westgard Dialog Box
Buttons
Description
Reset All

button is selected), any changes made to the
information in the QCID Setup will reset all three
pages back to their original content when the dialog
box was first opened to edit.
Finish
Accepts the data and any changes and returns to

QCID Setup: View dialog box
Cancel
Returns to QCID Setup: View dialog box
9. Select the Rule or Rules, if any, and click OK. The QCID Setup: View
dialog box opens, reflecting the newly created QCID information.
Whole Blood
PROCEDURE: CREATING A WHOLE BLOOD QUALITY CONTROL (QCID)
1. Select Setup from the menu bar and QCID Setup from the pull-down menu.
The QCID Setup: View dialog box opens.
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Table 11.27 Field QCID Setup: View Dialog Box

Field
Description
QCID Field
Quality Control ID selected from the pull-down menu
Control Type
Select from the pull-down menu: Commercial, Whole

Blood, Background
Test Selection
Type of test to be run, selected from the pull-down menu
Param Set
Select from the pull-down menu from 1 through 8
Comments
Table 11.28 Buttons QCID Setup: View Dialog Box

Buttons
Description
Edit
Create
Delete

dialog box
Close
2. Select Create and the QCID Setup: Basics dialog box opens.
Table 11.29 Field QCID Setup: Basics Dialog Box

Field
New QCID
Control Type
Description
Quality Control ID for new QCID file
Select from the pull-down menu: Whole Blood
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Table 11.30 Buttons QCID Setup: Basics Dialog Box

Buttons
Continue
Cancel
Description
Advances to the QCID Setup: Create New dialog box
3. Enter a name, or scan the bar code, if one is present, in the New QCID field
and select Whole Blood from the pull-down menu in the Control Type field.
4. Select Continue and the QCID Setup: Create New dialog box appears.
NOTE: The new QCID and Control Type are listed.
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Table 11.31 Field Dialog Box

Field
Description
Original Spec
Enter the whole blood original specimen ID number
Draw Date/Time
Enter the date and time of the blood draw. Select the
check box to activate the field and enter the
information. To set the dates and time do one of the
following:
Type the information in
Use the pull-down menu to set the information
Test Selection
Select the type of test from the pull-down menu:

CBC,CBC+NOC, etc.
Param Set
Select from pull-down menu, from 1 through 8
Comments
5. Select the QC Limits tab and the QC Limits tab opens.
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Table 11.32 Field QCID Setup: Create New, QC Limits Dialog Box
Field
QCID
Standard
Deviation N/A
Limits [+/-]
Description
Quality Control ID
N/A, not applying a standard deviation
NOTE: 2SD or 3SD must be selected to enable the
Westgard Rules
Displays the parameter-specific means, limits, and units
set up for the QCID file
6. Select Update Mean/Limits (+/-) and the Update Details dialog box opens.
Table 11.33 Field Means and Limits [+/-] Update Details Dialog Box
Field
Description
What to update
Select Means, Limits [+/-], or both Means and Limits

[+/-] radio button.
Standard Deviation
Select N/A, not applying a standard deviation, or

2SD, or 3SD.
1.
2.
Source
3.
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Select updates using existing QCID

specimens.
Update by copying from an existing QCID.
Select from the pull-down menu.
Update by uploading user created limits to the
QCID file. See the following procedure:
Retrieving From User Created Limits File.
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Table 11.34 Buttons Update Details Dialog Box

Buttons
OK
Cancel
Description
Confirms the change
Returns to the QCID Setup: View dialog box
7. Click OK and the QC Limits dialog tab opens.

NOTE: At the bottom of the dialog box: ! Means and/or limits (+/-) have
been updated.
8. Select the Westgard tab and Westgard dialog tab opens.
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Table 11.35 Field QCID Setup: Create New, Westgard Dialog Box
Field
QCID
Westgard Rules
Description
Quality Control ID
Rule
Westgard
Term
Description
1 sub 2S
Value outside 2SD
1 sub 3S
Value outside 3SD
2 sub 2S
Two consecutive values outside the same

2SD
R sub 4S
The range between two consecutive values

is greater than 4SD
2 of 3 sub 2S
Two of three consecutive values outside the

same 2SD
4 sub 1S
Four consecutive values outside the same

1SD
10x
Ten consecutive values on the same side of

the mean
Table 11.36 Buttons QCID Setup: Create New, Westgard Dialog Box
Buttons
Description
Reset All

button is selected), any changes made to the
information in the QCID Setup will reset all three
pages back to their original content when the dialog
box was first opened to edit.
Finish
Accepts the data and any changes and returns to

QCID Setup: View dialog box
Cancel
Returns to QCID Setup: View dialog box
9. Select the Rule or Rules, if any, and click OK. The QCID Setup: View
dialog box opens, reflecting the newly created QCID information.
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QCID File Deletion

PROCEDURE: TO DELETE A QCID FILE
1. From the Setup menu, select QCID Setup.
2. From the QCID pulldown menu, select the QCID to delete.
3. Select Delete.
4. A confirmation message displays. Select Yes.
5. The deleted QCID no longer displays in the QCID dropdown list.
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data log displays:
Draw Date: <blank>
Draw Time: <blank>
Lot Number: <blank>
Parameter set: 1
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QC Download ID Setup
The QC Download ID File Setup information is used to enter Laboratory
Identification information for the QCID file. This information is necessary for
participants in the CELL-DYN eQC Program. Laboratory Identification must be
entered before QC data can be transferred to the floppy disk.
PROCEDURE: QC DOWNLOAD ID SETUP
1. Select Setup from the menu bar and Administrative Setup from the pulldown menu.
2. Select QC Download ID File Setup and the QC Download ID File Setup
dialog box opens.
Table 11.37 Field QC Download ID File Setup Dialog Box

Field
Serial Number
Name
Set at the factory

Select a name
Address 1
Laboratory address
Address 2
Laboratory address
Town/City
Town or city in which laboratory is located
State
Description
State in which laboratory is located
Zip Code
Zip code
Country
Country
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Table 11.37 Field QC Download ID File Setup Dialog Box (Continued)

Field
Attention
Phone
Description
Name of contact person
Phone number of contact person
Table 11.38 Buttons QC Download ID File Setup Dialog Box

Buttons
OK
Cancel
Description
Accepts the information and closes the dialog box
Closes dialog box without saving information
3. Click OK and the QC Download ID File Setup dialog box closes.
Moving Average Acceptance Setup

Once enabled, the Moving Average Programs operate automatically and require
minimal direct operator action. The QC Status region provides information about
which programs are active and whether batches are in or out.
Turning Moving Average Programs On and Off
Moving Average Program monitoring can be turned on or off as desired. Abbott
recommends that the Moving Average Programs be used initially with the default
settings for acceptance limits and action limits until a laboratory can establish its
own values.
PROCEDURE: TURNING MOVING AVERAGE PROGRAMS ON AND OFF
1. Select Moving Average Acceptance Setup... from the pull down menu
under Setup on the menu bar. The Moving Average Acceptance Setup
dialog box opens.
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Table 11.39 Field Moving Average Acceptance Setup Dialog Box

Field
Description
Groups
X-B, WBC, RBC, RETC
Monitor Moving Average

On/Off
Select or deselect to monitor, or not monitor,

moving averages for the view selected
Table 11.40 Buttons Moving Average Acceptance Setup Dialog Box

Buttons
Default
OK
Cancel
Description
Resets the parameter lower/upper limits, target
values, and action limits to factory settings for the
selected view
Accepts changes and closes dialog box
Closes dialog box without saving information
2. Select or deselect the Monitor Moving Average On/Off checkbox for each
tab view.
3. Select OK to save the changes, and the dialog box closes.
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PROCEDURE: CUSTOMIZE MOVING AVERAGE VIEW
1. Select Setup from the menu bar and Customize Moving Average View...
from the pull-down menu. The Customize Moving Average View dialog
box opens.
.
IMPORTANT: Selecting the

button returns ALL settings on
EACH tab page of the dialog box to the default settings.
Table 11.41 Field Customized Moving Average View Dialog Box
Field
Groups
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Description
X-B, WBC, RBC/PLT, RETC:
Each is a separate page view
Available Columns
Determined for each page using the arrows
Selected Columns
Determined for each page using the arrows
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Table 11.41 Field Customized Moving Average View Dialog Box (Continued)
Field
Description
Add Heading
Remove Heading
Move column heading to the left

Move column heading to the right
2. Select the page to customize X-B, WBC, RBC, or RETC.

3. Remove or add a column to the selected page:
PROCEDURE: TO ADD A COLUMN TO A PAGE
a. Select the column header from Available Columns field.
b. Select the right arrow and the column header moves to the Selected
Columns field.
PROCEDURE: TO REMOVE A COLUMN FROM A PAGE
a. Select the column header from the Selected Columns field.
b. Select the left arrow and the column header moves to the Available
Columns field.
PROCEDURE: TO CHANGE THE ORDER OF THE COLUMNS
a. Select the column header in the Selected Columns field.
b. Select an arrow use the up arrow to move the column to the left in the
display view, or the down arrow to move the column to the right in the
display view.
4. Select one of the buttons.
Table 11.42 Buttons Customize Moving Average View Dialog Box
Buttons
Default
OK
Cancel
Description
Resets the column configuration to factory settings
for the view selected
Accepts the changes and closes the dialog box
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Performing a QC Run
Always mix and handle commercial control materials according to the directions
given on the package insert. Proper mixing is essential for accurate results.
PROCEDURE: TO PERFORM A QC RUN IN OPEN MODE
1. From the Next Open Tube Entry (NOTE) region using the mouse, click on
the QCID icon to display the QCID Lookup list of QCID files and select the
QCID Specimen ID you would like to run. The QCID Specimen ID selected
will automatically fill the NOTE region fields with the QCID, Specimen
Type, and Test Selection.
2. Remove the cap from a well-mixed control specimen tube and place the open
tube under the Open Mode Probe. Raise the tube so that the end of the probe
is deeply immersed in the specimen.
3. Press the Touch Plate to activate aspiration.
4. When you hear the audible beep, the well-mixed control has been aspirated
from the tube. Remove the specimen tube and replace the cap while the Wash
Block moves down to rinse the probe.
NOTE: Review any messages that may appear in the System Messages
region during the run cycle. Refer to Section 10: Troubleshooting
and Diagnostics and repeat the run if necessary.
5. Verify that control results are within your laboratorys acceptable limits.
6. If the control results fall within acceptable limits, review the data for shifts or
trends and then begin to process patient specimens.
NOTE: If one or more result falls outside the laboratorys acceptable limits,
review Section 10: Troubleshooting and Diagnostics. If the
problem persists, contact your Country Service and Support
Center. Do not process patient specimens.
Rejecting/Accepting Specimens
Specimens can be rejected or accepted as needed. For example, one or more runs
can contain results that you do not wish to use in determining the QCID file mean.
1.
2.
3.
4.
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To reject a QC specimen, proceed as follows:

From the QC View, highlight the specimen record from the log.
Select F8 QCID L-J Plots, then select F8 QCID Data.
From the QCID data view, highlight the specimen record and select F5
Reject to reject the specimen record from the QCID file data statistics. The
checkmark next to the rejected record will be removed. Rejecting a specimen
record does not remove the record from QCID file.
NOTE: Selecting F5 Accept will include the specimen record in the
QCID file data statistics.
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Edit QC Specimens
QC specimen runs can be edited to move from one QCID file to another. (For
example, if the Operator ran the incorrect level of control for the QC Specimen ID
selected in the Open Mode.) The QC specimen run can be moved to the correct
QCID file.
When moving one QCID file to another, the QCID file records must have the same
test selection and be of the same QCID type (i.e., Whole Blood, Commercial).
PROCEDURE: TO EDIT A QC SPECIMEN RUN

1. From the QC View, highlight the specimen record from the log.
2. Select F8 QCID L-J Plots and the Levey-Jennings format is displayed for
the selected specimen.
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3. Select F8 QCID Data and the QCID Data View opens.
4. From the QCID data view, highlight the specimen record and select F4 Edit
to open the QCID Edit dialog box.
5. Select the new QCID from the drop down list, enter an (optional) comment
in the Comment field, and select the OK button to close the dialog box.
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Moving QCID Specimen Runs from One QCID File to Another

To move QCID specimen run(s) from one QCID file to another, the user selects a
run or runs, and then changes the QCID file. When the user changes the QCID file,
the runs continue to display on the QC QCID View dialog box, but the Spec ID
column shows the new QCID number.
PROCEDURE: MOVING QCID SPECIMEN RUNS FROM ONE FILE TO ANOTHER
1. From the QC QCID View dialog box, highlight the row(s) to change the
QCID number (in the Spec Id column), and select the Edit function key.
2. The QCID Edit dialog box displays. From the Change to QCID dropdown
list, select the new QCID, and then click OK.
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3. The QC - QCID View dialog box displays. The highlighted row(s) display
with their QCID number (in the Spec Id column).
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Evaluating and Investigating Commercial

and Patient Control Results
The QC Status region and the System Messages region show the general status of
quality control programs and can provide an early indication of potential problems.
If one or more of the Westgard Rules has been violated, a warning message is
displayed in the System Messages region and the Rule Alert field in the QC
Status region will indicate Yes. Moving Average Program monitoring can be
turned on or off as desired. If one or more of the closed batch data sets for each
Moving Average Program is out-of-limit, the Moving Average Program will
indicate OUT next to the program parameter title in the QC Status region. The
Operator should investigate to determine whether any intervention or corrective
action is needed.
If there is a problem, the operator should attempt to attribute the cause to the
control material, procedural error, reagents, or System operation. The operator can
do the following:
Review all information in the QCID File(s) involved
Open the QCID Setup dialog box for the QCID File(s) and check that the
means and limits are within acceptable limits according to the package insert
or the laboratorys historical ranges
Review the Reagent, Maintenance, and System Logs to see if reagent
changes, maintenance procedures, or other events could be the cause or could
have contributed to the problem
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Section 11
Review the Moving Average Programs and Datalog to see if the patient
samples exhibit a similar shift or trend
Review the Calibration Log for records of recent calibration and any specific
comments and remarks
Examine the System setup settings to ensure that the operating conditions and
setups are correct
For additional guidance in isolating problems with data, refer to Section 10:
Troubleshooting and Diagnostics.
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Analyzing QCID File Results

Levey-Jennings graphs are a visual method of viewing quality control result data
for all parameters over time. These graphs allow the Operator to examine the
relationship of control result values to the established means and acceptable limits,
and to look for shifts and trends in results. All specimens in the QCID file will be
graphed. There are six customizable parameter tabs on the Levey-Jennings view.
The graph label will include the parameter being graphed and Westgard Rule
warnings for that parameter. Scale values on the left side of the graph indicate:
Solid black line is the mean
Dotted orange line is the 2SD
upper and lower limits
Solid red line is the 3SD upper
and lower limits
CAUTION: QC limits are assumed to be at 2SD for Westgard Rule
analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QCID Setup, QC Limits tab represents 2SD for
the laboratory for each parameter before interpreting Levey-Jennings
graphs and Westgard Rules.
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Values in the QCID file which are outside of the graph range will appear above the
solid red line.
NOTE: Results from rejected specimens will not appear on the graph.
Westgard Rule Analysis

To allow for analysis of CELL-DYN Ruby System quality control results, a rule
exists to test control results against control limits to determine whether the
instrument shows acceptable accuracy and precision. The limits are derived from
the mean and standard deviation of control measurements when instrument
performance is stable and acceptable. The most common rule used in hematology
quality control is the mean 2SD. Ninety-five percent of control results should fall
within 2SD.
Quality control results detect random or systematic error. Random error may be
defined as an increase in the SD (loss of precision). Systematic error may be
defined as a shift in the mean value (loss of accuracy). A multi-rule quality control
procedure combines several control rules to improve the detection of both types of
error.
Westgard recommended a multi-rule approach to evaluating quality control
results.2 This approach has long been used in the chemistry laboratory.3 A set of
modified Westgard Rules can be selected to monitor quality control results on the
CELL-DYN Ruby System.
Westgard Rules for the CELL-DYN Ruby

The modified Westgard Rules (Westgards nomenclature is given in parentheses)
available on the CELL-DYN Ruby are:
Rule 1 (1 sub 2S) Value outside 2SD.
Rule 2 (1 sub 3S) Value outside 3SD.
Rule 3 (2 sub 2S) Two consecutive values outside the same 2SD.
Rule 4 (R sub 4S) The range between two consecutive values is greater than 4SD.
Rule 5 (2 of 3 sub 2S) Two of three consecutive values outside the same 2SD.
Rule 6 (4 sub 1S) Four consecutive values outside same 1SD.
Rule 7 (10x) Ten consecutive values on the same side of the mean.
The rules may be used singly or in combination, depending on Operator preference,
and are configurable for each QCID.
Selections are made in the QCID Setup, Westgard tab. See also
Subsection: QCID File Setup.
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When a rule is selected (turned ON), a plus sign is displayed to the right of the
parameter. A minus sign is displayed if a rule is not selected (turned OFF). Rule
violations for a parameter are recorded above the Levey-Jennings graph for that
parameter. Whenever a rule is violated, the number of the rule will be displayed to
the right of the parameter in place of the plus sign.
CAUTION: QC limits are assumed to be at 2SD for Westgard Rule
analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QCID Setup, QC Limits tab view represents the
laboratorys 2SD range for each parameter before interpreting LeveyJennings graphs and Westgard Rules.
The rule violations listed above the graphs represent the modified Westgard Rule
status of the most recent control sample processed.
CAUTION: Do not use the values for mean range provided on the control
assay sheet in conjunction with Westgard Rules. Before using Westgard
Rule with commercial controls, establish the SD for each parameter on your
instrument and update QC limits based on these SDs.
Rule Violations
Only the directly measured parameters need to be monitored with multiple rules.4
In Laboratory Quality Management, Cembrowski and Carey suggest a protocol for
using the Westgard Rules in hematology. The following is a synopsis of that
protocol.
Because all three levels of control are typically used to monitor a hematology
analyzer, it is reasonable to consider all three at the same time. In other words,
check for rule violations across the three levels, not just within a particular level. If
the same rule is violated for more than one level, determine whether the violation
indicates a loss of precision or a loss of accuracy and troubleshoot accordingly.
Cembrowski suggests that the results for all three levels first be checked to see if
they are within their 2SD limits. If all three levels meet this criterion, the
instrument is in control.
If any control result exceeds the 2SD limits, check to see if it exceeds the 3SD
limits. If a result exceeds 3SD, there are two possibilities. There is either an
instrument problem or a problem with one particular level of control. Therefore, if
a result exceeds 3SD, run another vial of that control. If the problem persists, then
additional investigation is required.
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Check to see if the 2 of 3 sub 2S or R sub 4S rules have been violated for any level
or across levels. If the problem is confined to one level of control, check for a 2 sub
2S rule violation for that level. Again, if the violations are confined to one level of
control, use another vial and possibly another lot. Verify and follow all storage,
mixing, and handling instructions provided in the control package insert. Check
expiration dates and data entry. Check to be sure that the control is run into the
correct file, and the means and limits have been entered correctly for the particular
lot number in use.
If a combination of rules has been violated across three levels, determine whether
the violations indicate a loss of precision or a loss of accuracy, and troubleshoot
accordingly. Do not process patient specimens. If necessary, contact your Country
When the problem has been resolved, Cembrowski suggests that all levels be run
again in duplicate to confirm that the problem has in fact been corrected.
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Moving Average Programs

Overview
The Moving Average programs on the CELL-DYN Ruby automatically and
continuously monitor instrument performance. This allows identification of
potential problems and more efficient troubleshooting. The programs track the
results of various parameters in the patient population analyzed on the System. On
the CELL-DYN Ruby, the Moving Average Programs and their associated
parameters and measurements include the following:
X-B Program: MCV, MCH, MCHC
WBC Program: WBC, %N, %L, %M, %E, %B and population statistics
(mean) for neutrophils and lymphocytes
RBC/PLT Program: RBC, RDW, HGB, HCT, MCH, MCHC, MCV, PLT, and
population statistics (mean) for linear RBC, PLT, and RBC
RETC Program: %R and population statistics (mean) for RETC
Any combination of Moving Average Programs can be active. The settings for each
Moving Average Program can be controlled independently of the other Moving
Average Programs.
Population statistics are also used by Abbott field personnel to evaluate fluidics or
other system problems, and are explained in Subsection: Principles of Moving
Average Analysis within this section.
How Moving Average Programs Work

On the CELL-DYN Ruby, Moving Average Programs calculate means for each
parameter in batches of 20 samples. Each program can be customized to display
from 20 to 120 batches and allows a wide acceptance range for data results. The
software includes a moving average statistical formula that smooths and trims data
to minimize the weight of outliers and calculates a mean for each parameter. The
calculated mean for each new batch is compared to the target value and its action
limits. If the mean for a batch falls outside the action limits, the QC Status region
is updated to indicate that the batch is OUT1. If the means for the last two
calculated batches of data for an individual Moving Average Program fall outside
the acceptance limits, the QC Status region is updated to indicate that the batch is
OUT2. For guidance, refer to Subsection: Investigating Moving Average Data
Problems within this section.
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Principles of Moving Average Analysis

Moving average analysis for hematology originated with X-B analysis, an
automated means of monitoring performance by using the known stability of the
red cell indices (MCV, MCH, MCHC). X-B stands for XB, which is the symbol for
the mean and used in calculating moving averages of the RBC indices with an
algorithm developed by Dr. Brian Bull. The CELL-DYN X-B Program uses similar
algorithms to monitor System performance by tracking the red cell indices from
patient data analyzed on the System.
On the CELL-DYN Ruby, this approach is extended by applying algorithms
similar to those of Dr. Bull for Moving Average Program analysis of other RBC/
PLT parameters (RBC, RDW, HGB, HCT, PLT), WBC, and %R parameters. This
approach is also extended to certain measured values called population statistics,
which consist of means of channel data for optical measurements.
Results for other RBC/PLT parameters, WBC, and %R parameters have a wide
range of absolute and percentage values. However, despite significant variation in
these parameters, the optical measurement population statistics for WBC, PLT, and
%R remain relatively constant from specimen to specimen. The population
statistics are therefore sensitive to changes in the Systems optical measurement
process and can be used in Moving Average Program analysis.
Moving Average Programs on the CELL-DYN Ruby use the following three
categories of numerical settings:
Upper and lower acceptance limits that determine which patient results are
used in a batch. These limits are set widely to exclude only grossly abnormal
specimens.
The target value, which is the expected mean of the parameter results, is
analogous to the assay value for a commercial control. Target values are
derived from the patient population analyzed on the System.
The action limit, which is the acceptable limit of variation around the target
value of the mean for a batch, expressed as a percentage.
NOTE: Abbott recommends that the Moving Average Programs be used
initially with the default settings for acceptance limits and action
limits until a laboratory can establish its own values. Target values
and action limits can be adjusted according to the guidelines
described in the following subsections.
Guidelines for Setting Up X-B Moving Average Program Analysis

It is recommended that the CELL-DYN Ruby be operated with the X-B program
turned on.
The default acceptance limits have been set so that at least 95% of patient results
are used in the X-B Program calculation. In the event that a laboratory has a highly
specialized patient population, the limits can be adjusted. For details about
adjusting acceptance limits, refer to Subsection: Moving Average Acceptance
Setup.
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A study5 by Dr. Bull collected data from 1767 patients and yielded the following
mean values for the red cell indices:
MCV = 89.9 fL
MCH = 30.5 pg
MCHC = 33.9 g/dL
These values confirmed other data that Dr. Bull published in an earlier study6 and
are used in the CELL-DYN Ruby as the default target values for beginning X-B
analysis.
The default action limit for the red cell indices is set at 3%.
Each laboratory should confirm the default values and, if necessary, establish its
own target values for the RBC indices. The action limits can be set to 5% during
the study period and tightened to 3% when the target values are confirmed. Refer
to Subsection: Establishing the Target Value immediately following.
A suggested protocol and guidelines for interpreting data based on X-B analysis
can be found in Chapter 1 of Laboratory Hematology, An Account of Laboratory
Techniques, edited by I. Chanarin.7
Establishing the Target Value

1. Calibrate the System.
2. Ensure that the calibration is stable and control results are acceptable during
data collection.
3. Collect data from at least 20 batches of 20 specimens each for a minimum
total of 400 specimens. Specimens should represent your laboratorys typical
population.
4. To understand how to use CELL-DYN Ruby software to view Moving
Average Program data, review Moving Average Program Operation later in
this section. Using the F8 - Closed Batch Data view in the QC Moving
Average view, examine the batch means. View the Levey-Jennings graphs of
the batches and determine whether the results are acceptable for MCV, MCH,
and MCHC.
5. When the results are determined to be acceptable, manually average the mean
values for 20 batches, enter these averages as the target values, and set the
action limits to 3% for all parameters. For instructions on how to change the
target values and action limits, refer to Subsection: Moving Average
Acceptance Setup.
6. Evaluate data from a minimum of 400 additional specimens to ensure that
entered target values are appropriate.
Laboratories seeing specialized patient populations, e.g. pediatric hospitals or
tumor centers, may need to verify these values due to abnormal patient
populations. Target values may be verified by evaluating approximately 400
samples and comparing the X-B means for those samples to the entered target
values. This can be done as follows:
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1. Collect data from at least 400 patients. (The 1.5% is one-half the allowable +
3% action limit.) If the CVs are greater than 1.5%, an additional 400 samples
should be evaluated.
2. If the CVs calculated in step 1 are less than 1.5%, enter the mean as the
Confirmed Target Value.
Guidelines for Interpreting X-B Moving Average Program Analysis

When X-B results are out of control, data should be reviewed for shifts and trends
in the results.
Shifts in results are usually caused by a non-random batch of 20 specimens such as
those from dialysis or pediatric units. Multiple repeats of the same abnormal
specimen within a given batch of 20 may also cause a non-random population in
that batch. Shifts caused by non-random data will usually be corrected in the next
batch of 20 as long as those data are random.
Shifts may also be caused by a change in reagent container or a lot number change.
If containers or lot numbers recently changed, try another container and see if the
problem persists.
Calibration changes may also cause a shift in results. If a shift cannot be explained
as described above, run commercial controls or run a patient selected from a
previous batch when X-B results were in control. If values are within acceptable
limits, a calibration shift is not the cause of the problem.
Trends in X-B results are usually caused by instrument problems. A recent
component change may also cause a trend in results. Use the following table to
determine the directly measured parameter(s) involved, and troubleshoot
accordingly. If a problem is not readily identified, perform routine maintenance
and repeat the commercial and patient controls to see if results are acceptable.
Since two of the RBC indices are calculated parameters, their inter-relationships
can be used to assist in troubleshooting. The following table uses the mathematical
relationships between the indices to aid in determining which directly measured
parameter(s) are involved when X-B is out of control. When the directly measured
parameter(s) are identified, refer to Section 10: Troubleshooting and Diagnostics
for troubleshooting assistance with these parameters.
Table 11.43 Troubleshooting X-B RBC
If the MCV
11-78
If the RBC
If the HGB
X-B
Pattern
is
increased
is
decreased
is
increased
is
decreased
is
increased
is
decreased
Index
Derivation
MCV
will be
High
Low
N/A
N/A
N/A
N/A
MCV
MCH
will be
N/A
N/A
Low
High
High
Low
HGB/RBC
MCHC
will be
Low
High
Low
High
High
Low
HGB/HCT
Section 11
Quality Control
Guidelines for Setting Up and Interpreting Other Moving Average

Programs
Use the default acceptance limits for parameters in the other Moving Average
Programs (WBC, RBC/PLT, and RETC). Adjust the limits only after longterm monitoring indicates that this is warranted.
Use the preceding steps to establish the target values for the other Moving
Average Programs. If necessary, action limits can be widened from default
settings during the study period. Using the default action limits for the
neutrophil and lymphocyte optical populations is strongly recommended.
It is recommended that these additional moving average programs be turned
on during routine operation, allowing data to be collected for use in
troubleshooting.
Because the WBC Differential parameters have a wide dynamic range, it is difficult
to use a moving average algorithm to control these results. Therefore, the
CELL-DYN Ruby System uses data obtained from the MAPSS technology used
for the WBC Differential measurement.
Five main subpopulations of WBC, which can vary widely in absolute number and
percentage values, are identified by the CELL-DYN Ruby System. Even though
these parameters have varying dynamic ranges, they maintain a relatively constant
modal position on each axis of the scatterplots. It is expected that these optical
characteristics of the WBC Differential subpopulations will remain stable over
time without impact from the wide dynamic ranges of the individual parameters.
This constant modal position, which is sensitive to changes in the instruments
optical measurement process, can be monitored by the instrument and used to
monitor the WBC Differential parameters in much the same way that the RBC
indices are used to monitor the RBC parameters.
The CELL-DYN Ruby System monitors the modal positions of the lymphocyte
and neutrophil clusters on each axis of the 0/10 scatterplot. It also monitors the
modal positions of the neutrophil cluster on each axis and the angle of the
neutrophil/eosinophil separation on the 90/90 depolarized scatterplot. These
seven measurements are then averaged for each batch of 20 patients using a moving
average calculation similar to that developed by Dr. Bull for the RBC indices. For
convenience, this process is called X-B WBC.
Each laboratory should establish its own target value for the X-B WBC parameters.
It is suggested that the process be started by using the default (preset) values
displayed in the following table. The action limits in the table may be used or
widened during the initial analysis. Reenter the default action limits shown in the
following table when the Target Values are confirmed. The values for the action
limits may be widened depending on the specimen population analyzed by the
laboratory. The values for the Lower/Upper Acceptance Limits may also be used
or widened depending on the specimen population analyzed by the laboratory.
11-79
Quality Control
Section 11
Collect data from 20 batches of 20 specimens each for a total of 400 specimens.
Data collection should be from specimens which represent the typical specimen
population that is processed through the instrument. When all 20 batches are
complete, print the Moving Average Program WBC tab view. Refer to
Subsection: Printing Moving Average Programs Information. Calculate the
mean, standard deviation (SD), and coefficient of variation (CV) for each
parameter. The CV for LYM 0, LYM 10, NEU 0, and NEU 10 should be
<2.5%. The CV for NEU 90, NEU 90 depolarized, and NEU-EOS should be
<5%. If the CV for each index meets these criteria, enter the calculated mean value
as the target value and set the action limits to 5% for LYM 0, LYM 10 NEU 0,
and NEU 10, and to 10% for NEU 90, NEU 90 depolarized, and NEU-EOS.
NOTE: Laboratories analyzing specialized patient populations (as described
above) may need to widen the action limits slightly to accommodate
results from these abnormal patients.
If the CV for each index is more than the limits described above, evaluate another
400 specimens and repeat the calculations.
When an acceptable target value has been entered, evaluate data from an additional
400 specimens to confirm the entered values.
Default (Preset) X-B WBC Values
Table 11.44 X-B WBC ValuesDefault
Parameter
Acceptance
Limits
Target Value
Action Limit
LYM 0
20100
64
20%
LYM 10
20130
63
20%
NEU 0
100210
168
20%
NEU 10
90210
156
20%
NEU 90
40160
127
20%
NEU 90 DEP
070
20
20%
NEU-EOS
040
21
30%
Interpreting X-B WBC Results

A suggested protocol and guidelines for interpreting X-B data can be found in
Chapter 1 of Laboratory Hematology, An Account of Laboratory Techniques,
edited by I. Chanarin.7
11-80
Section 11
Quality Control
Moving Average Program Operation

Once enabled, the Moving Average Programs operate automatically and require
minimal, if any, direct operator action. The QC Status region provides information
about which programs are active and whether batches are in or out.
One Batch Out
A single batch out is indicated as OUT1 (in orange). This occurs when only the
most recent closed batch is out and the current batch is still not calculated (fewer
than 20 specimens processed), or when the previous closed batch is in and the
current calculated batch (20 specimens processed) is out.
Two Batches Out
If a second batch goes out, this is indicated as OUT2 (in red). This occurs when the
previous closed batch is out and the current calculated batch (20 specimens
processed) is also out. For information on investigating Moving Average data
problems, refer to Subsection: Investigating Moving Average Data Problems
Data Collection Process

Data for Moving Average Programs are automatically collected. If the monitoring
Moving Average Programs are selected to OFF, the QC Status region will display
dashes next to the parameter titles. When the monitoring Moving Average
Programs are selected to ON, the data is managed as follows:
As each specimen is processed, the System checks to see which Moving Average
Programs are on, and whether the specimen meets the acceptance criteria. For
example, specimens that triggered System Faults are not accepted into the X-B
Moving Average program files. Results for accepted samples become part of the
current batch for active Moving Average Programs.
20 specimens are used to calculate statistics for the closed batch.
NOTE: The number of specimens in the current batch displays in the QC Status
region; however, the Moving Average Program view only displays closed
batch statistics. The status of the last closed batch displays in the QC
Status region. If the batch status has been OUT2, it remains OUT2 until
the next closed batch results are calculated.
Each Moving Average Program has a number of parameter column headings for
viewing numerical data and information for basic data management functions.
Each parameter column heading is also displayed in the form of Levey-Jennings
graphs.
11-81
Quality Control
Section 11
Investigating Moving Average Data Problems

Use the following guidelines to determine the causes for Moving Average Program
batch data being out, and to take preliminary action.
Investigating One Batch Out

1. A high proportion of non-randomized specimens can be considered a cause
of the closed batch going out. If results for closed batches are abnormal in the
same direction, all high results or all low results, the samples can be
considered the cause of the batch going out.
2. If such specimens are present, document the situation and continue to process
specimens.
3. If there are no such specimens, consider the batch out event as a warning.
Check controls, monitor results, and follow your laboratorys procedures.
Investigating Two Batches Out

Follow your laboratorys procedures. If your laboratory has no specific procedures,
try the following:
1. Run both commercial and patient controls. Select one or more patient
controls with results obtained during a time when the Moving Average
Program batch was in. If control results fall within acceptance limits but have
shifted, follow your laboratorys procedures.
2. If you suspect that there are no specimen-related reasons for the closed batch
to be out, check the control results, and check the Reagent, Maintenance,
Calibration, and System Logs for events that could have led to closed batch
results falling outside the action limits.
For information about how to view these logs, refer to Section 9: Service and
Maintenance, Subsection: Service and Maintenance Software.
If the control results also fall outside the limits, begin troubleshooting,
document the source of the problem, and take corrective action. For further
information, refer to Section 10: Troubleshooting and Diagnostics.
Printing Moving Average Programs Information

Moving Average Program reports can be printed for closed batches for each
Moving Average Program, along with Levey-Jennings graphs. The printout
contains the last closed batch Moving Average Acceptance Setup information and
may not match the current Moving Average Acceptance Setup dialog box if the
setup was changed since the last batch closed.
NOTE: For the WBC and RBC/PLT moving average program printing, use File,
Print Setup to change paper orientation to Landscape and File, Print
Preview to make sure the printout meets your labs expectations before
selecting F1 Print. Use Setup, Customize Moving Average View to
customize the parameter column headings you want to print.
11-82
Section 11
Quality Control
Customizing Moving Average Programs

Moving Average Programs on the CELL-DYN Ruby have been carefully designed
to meet the needs of most laboratories and should require minimal customization.
However, each program can be customized independently if necessary. Abbott
recommends using the factory settings for the initial 25 batches. For an explanation
of the factory settings and for information about adjusting the means, refer to
Subsection: Principles of Moving Average Analysis within this section. For
complete customization procedures, refer to Subsection: Moving Average
Acceptance Setup.
11-83
Quality Control
Section 11
NOTES
11-84
Section 11
Quality Control
References
1. Cembrowski GS, Carey RN. Laboratory quality management, p. 189.
2. Westgard JO et al. A multi-rule Shewhart chart for quality control in clinical
chemistry. Clin Chem 1981; 27:3:493501.
3. Cembrowski GS, et al. Use of a multirule control chart for the quality control
of PT and APTT analyses. Lab Med June 1989; 418421.
4. Cembrowski GS, Carey RN. Laboratory quality management. P. 190.
5. Bull BS, Jones AR, Gibson M, Twedt D. A method for the independent
assessment of the accuracy of hematology whole blood calibrators. AJCP
(accepted for publication), 1992.
6. Bull BS, Korpman RA. Intralaboratory quality control using patients data.
In: Cavill I, ed. Quality Control. Edinburgh: Churchill Livingstone 1982,
121150.
7. Chanarin I, ed. Laboratory hematology, an account of laboratory techniques.
Edinburgh: Churchill Livingstone, 1989:37.
11-85
Quality Control
Section 11
References
NOTES
11-86
Section 12 Reticulocyte Package
Section 12
Overview
The Reticulocyte Package software enables the operator of the CELL-DYN Ruby
System to analyze a whole blood specimen for reticulocytes. The Reticulocyte
specimen is prepared by the operator using reticulocyte reagent to produce a
diluted, stained sample. Reticulocyte specimens can be run as batches, or they can
be run on a STAT basis.
The Reticulocyte Package is enabled by selecting the Retic test selection in the
Next Open Tube Entry (NOTE) region and acknowledging the message to run the
reticulocyte method startup script. Reticulocyte processing and specimen
demographic orders can be added to the CELL-DYN Ruby manually or
automatically via the Laboratory Information System (LIS). See Section 5:
Operating Instructions, Subsection: Pending Orders in Open Mode. The
Reticulocyte Package is disabled by selecting either of the test selections: CBC,
CBC + NOC, CBC + RRBC in the Next Open Tube Entry (NOTE) region and
acknowledging the message to run the reticulocyte method cleanup script.
NOTE: The cleanup script takes approximately three minutes to return the
Analyzer Status to Ready state.
When the prepared reticulocyte specimen is run on the CELL-DYN Ruby, results
are measured as reticulocyte percent (%R). The reticulocyte absolute value
(RETC) is automatically calculated when the RBC concentration is entered using
the F12 RBC Source function key.
Reticulocyte results are stored chronologically in the Datalog view. Reticulocyte
Quality Control ID (QCID) File Setup, control material processing in the Open
Mode, control results analysis and file data management, Westgard rules, LeveyJennings graphs, and Moving Average Programs can all be displayed in QC View.
For more information on the Datalog view and QC View see Section 5: Operating
Instructions, Post-Analysis Processing Datalog View and Section 11: Quality
Control.
This section contains the following subsections:
Setup Guidelines
Retic Test Selection
Enabling Reticulocyte Processing
Disabling Reticulocyte Processing
Routine Operation
Reticulocyte Specimens
Quality Control
Maintenance and Troubleshooting
12-1
Section 12
Overview
NOTES
12-2
Section 12
The Reticulocyte Package software is designed to configure the instrument to
process stained, diluted specimens. When the System is enabled to run the RETIC
test selection, the instrument automatically selects the appropriate configuration
file and adjusts the instrument settings to the values in this file. This configuration
is retained until the System is disabled by selecting a non-reticulocyte test selection
and executing the reticulocyte method cleanup script.
Reticulocytes are defined by the Clinical Laboratory and Standards Institute
(CLSI) as transitional red cells, between nucleated red cells and the so-called
mature erythrocytes.1 In contrast to mature RBC, reticulocytes contain ribosomal
RNA. This RNA can be seen with certain supra vital, cationic dyes that
simultaneously stain and precipitate the polyanion to form a network or reticulum.
The CELL-DYN Ruby System reticulocyte method uses the thiazine dye New
Methylene Blue N. The reticulocyte assay is performed in the WOC channel of the
instrument. Sample preparation is performed manually by dispensing 20 L of
blood into a tube of CELL-DYN Reticulocyte Reagent. At room temperature,
staining of reticulum is complete within approximately 15 minutes. The stained
sample is aspirated in the Open Mode. After the stained sample is aspirated, it is
diluted approximately 50-fold with WBC Lyse Reagent. Once diluted with WBC
Lyse, the RBC sphere due to the influence of the nonionic detergent incorporated
into the staining solution. Sphering is necessary to eliminate optical orientational
noise that would otherwise be introduced into the scatter measurements. The usual
lytic action of the WBC Lyse is prevented by electrolytes contained in the staining
solution and the lack of the usual incubation period used in this channel during
WBC analysis. In addition, the high New Methylene Blue concentration in the
staining reagent exerts a stabilizing effect on RBC.
During data acquisition, 0 degree, 10 degree, and 90 degree scatter are collected for
up to 30,000 events. The 0 degree threshold is set high enough to exclude most
platelets. Histogram data are used to differentiate reticulocytes from mature RBC,
platelet clumps, and nucleated cells. Reticulocytes have 10 degree scatter that are
similar to the scatter for mature RBC, but differ from them by exhibiting greater 90
degree scatter. Reticulocytes are reported in percent (%R). The instrument will
automatically calculate the Reticulocyte Absolute value if an RBC concentration is
entered using the F12 RBC Source function key.
RUN VIEW
When the reticulocyte results fall outside patient limit sets, the result is displayed
in color on the screen to alert the operator. Results displayed in yellow are below
the limit, results displayed in purple are above the limit, and these flagged results
are underlined on the printed report. Patient results that exceed the linearity
specifications will be suppressed and (>>>>) will be displayed and printed.
12-3
Section 12
Patient Run View Chartable Page
12-4
Section 12
Patient Run View Graphs Page
12-5
Section 12
Datalog RETC Tab View
12-6
Section 12
Setup Guidelines
The CELL-DYN Ruby System software is configured to automatically analyze the
prepared reticulocyte specimen in the Open Mode when the Analyzer Status
indicates Ready state and RETIC is displayed in the <Test Selection> field of the
Open Tube Next Entry (NOTE) region. Datalog and QC View are customizable
for the display of the reticulocyte results.
NOTE: The single specimen run views (parameter sets) for reticulocyte results are
not customizable; however, the customized printed report can be
configured to include printing the graphs or not.
To customize units and patient limit sets for %R and RETC parameters, see Section
2: Installation Procedures and Special Requirements,
Subsection: System Customization. Refer to Section 5: Operating Instructions,
Subsection: Setup Guidelines for the tasks involved to configure the
CELL-DYN Ruby to your laboratorys requirements.
12-7
Section 12
Setup Guidelines
NOTES
12-8
Section 12
RETIC Test Selection

Specimen analysis is performed in the Open Mode.
NOTE: To ensure optimal flagging, the CBC must have been run within 8 hours
prior to the Retic run on the same analyzer using the same specimen.
NOTE: Specimen IDs must match exactly and are case sensitive.
Retic Test Selection
12-9
Section 12
RETIC Test Selection
Enabling Reticulocyte Processing

PROCEDURE: SELECTING RETIC TEST SELECTION TO ENABLE RETICULOCYTE
METHOD
1. Verify the Analyzer Status indicates Ready state and Open mode, select the
RETIC test selection in the NOTE region to open the message dialog box.
2. Select OK to run the Reticulocyte Method Startup Script and enable

reticulocyte processing.
The software to analyze reticulocytes is now enabled on the
Disable Reticulocyte Processing

PROCEDURE: SELECTING A NON-RETIC TEST SELECTION TO DISABLE
RETICULOCYTE METHOD
1. Verify the Analyzer Status indicates Ready state and Open mode, select the
CBC test selection in the NOTE region to open the message dialog box.
2. Select OK to run the Reticulocyte Method Cleanup Script and disable

reticulocyte processing.
When the Reticulocyte method is disabled, the instrument automatically runs a
wash cycle and returns the Analyzer Status to the Ready state.
CAUTION: If the instrument has been idle for four hours in the RETIC
test selection, it enters the STANDBY state without running a cleaning
cycle. If this happens, perform an Auto-Clean cycle before using the
instrument again.
12-10
Section 12
Routine Operation
Overview
This section contains information and procedures that are recommended for the
routine operation of the Reticulocyte Package for the CELL-DYN Ruby System.
This section contains the following subsections:
Specimen Requirements
Running Specimens
RETC_Background Counts
Quality Control
Specimen Preparation
Patient Specimens
This subsection discusses routine operation of the Reticulocyte Package.
Guidelines and procedures are provided for running RETC_Background counts,
quality control, and patient specimens. Proper start-up procedures should be
performed prior to processing patient specimens. The Reticulocyte Package is only
available for use in the Open Mode.
For RETC_Background counts a tube of reticulocyte reagent is run without an
aliquot of whole blood to check for particulate material in the reagent and system.
RETC_Background counts should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratorys protocol
and with each new lot of reagent.
Always mix and handle commercial control materials according to the directions
given on the package insert. Proper mixing is essential for accurate results. Patient
reticulocyte controls should be run and handled according to the laboratorys
protocol. Quality control checks should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratorys protocol.
The operator enters the reticulocyte specimen ID to be run (Patient, QCID, or
RETC_Background) into the Specimen ID QCID field of the Next Open Tube
Entry (NOTE) region. If the specimen ID is matched to a record in the Orders
view, the System will display there is a match and the specimen demographics from
the pending order will be used in the Next Open Tube Entry (Detailed) dialog
box. See the following graphic example. When the reticulocyte sample is
completed and the Analyzer Status indicates Ready, the operator can then enter a
new specimen ID for the next specimen to run. Specific instructions for each
specimen type are given later in this section.
12-11
Section 12
Routine Operation
RETIC Test Selection Pending Orders Match View
Specimen Requirements
A fresh non-hemolyzed, whole blood specimen collection in K2EDTA is the
specimen of choice for Reticulocyte analysis on the CELL-DYN Ruby System.
Specimens may be run up to 8 hours after collection time when stored at room
temperature.
NOTE: Studies have shown that reticulocytes continue to mature at room
temperature. Increased flagging can occur when using specimens more
than 8 hours old.
If a delay in analysis is anticipated, specimens may be processed up to 72 hours if
stored at refrigerated temperature.
Refrigerated samples must be brought to room temperature before mixing; this
avoids damaging any fragile cells.
For the Absolute Reticulocyte calculation, it is recommended that the RBC
concentration used must be selected from the same specimen that will be used for
the Reticulocyte count and preferably run on the same analyzer.
12-12
Section 12
F11 RBC Source
When the F11 - RBC Source key is used to locate the RBC count, the system alerts
the operator when a valid result is not found. If a specimen is more than 8 hours old
and the CBC was processed more than 8 hours prior to performing the Reticulocyte
analysis, manual entry of the RBC value is an option. The System will alert the
Operator if the manual entry of the RBC value exceeds the software limit. See the
following two graphic examples. If the RBC value is not entered, only the %R
value will be obtained.
12-13
Section 12
Routine Operation
The CELL-DYN Ruby Reticulocyte method is a nucleic acid staining method.
Therefore, other substances that contain nucleic acids could potentially be
enumerated by the instrument as reticulocytes. If these interfering substances are
present in sufficient numbers, they may interfere with the dynamic thresholds used
to obtain the CELL-DYN Ruby reticulocyte count. Consequently, these specimens
should be flagged by the instrument. Refer to Subsection: Maintenance and
Troubleshooting, Operational Messages and Data Flagging within this chapter
for a complete description of the Reticulocyte flags.
The information in the following table, based on CLSI Document H44-A21,
indicates substances that are known or potential interference. The
CELL-DYN Ruby Reticulocyte procedure is designed to minimize some common
interference, including high WBC counts and NRBC.
Table 12.1
Known or Potential Interferences
Cellular Elements
Platelet clumps
Basophilic stippling
Giant platelets
Leukocytes and
leukocyte fragments
Nucleated erythrocytes
12-14
Cellular Inclusions
Miscellaneous
Howell-Jolly bodies
Heinz bodies
Pappenheimer bodies
Parasites (malaria,
babesia)
Abnormal red cells

Paraproteins
Cold agglutinins
Platelet/erythrocyte
coincidence
Hemolysis
Section 12
Specimen Preparation
CAUTION: When using the reticulocyte reagent, avoid contact with skin
and clothing. This reagent contains New Methylene Blue, which will stain
skin, clothing, and many other surfaces.
WARNING: Potential Biohazard. Consider all clinical specimens,
calibrators, and controls that contain human blood or serum as potentially
infectious. Wear gloves, labcoats, and safety glasses and follow other
biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
PROCEDURE: SPECIMEN PREPARATION
1. The Reticulocyte Package is available for use only in the Open Mode.
2. Use reticulocyte reagent and verify the expiration date. Store the stock
reagent in the dark at room temperature.
3. Label a tube of reticulocyte reagent for each patient.
4. Verify that the whole blood specimen is warmed to room temperature and
well mixed prior to sampling.
5. Pipette 20 L of the whole blood specimen into each labeled tube of
reticulocyte reagent.
6. Incubate the stained Reticulocyte specimens on a rotator or in a rack, after
fully inverting the stained specimens 5 times. Incubation must be performed
according to the reagent package insert.
NOTE: The stained Reticulocyte specimens must incubate for at least 15
minutes but no more than 2 hours prior to processing on the
This timing will allow the Reticulocyte specimens to be processed for STAT
requests. Reticulocyte specimens can also be grouped and run in batches, provided
that the 2-hour maximum incubation time limit is not exceeded.
Running Specimens
RETC_Background Counts
The reticulocyte background (RETC_Background) count should be included in the
daily start-up procedures to check for particulate matter in the reticulocyte reagent
and the CELL-DYN Ruby System. The RETC_Background count is determined
from the total counts that occur in the reticulocyte scatter area on the 10/90
scatterplot.
NOTE: Confirm that the RETC_Backgound count is within acceptable limits
before running controls or patient specimens.
12-15
Routine Operation
Section 12
PROCEDURE: RETC_BACKGROUND COUNT

1. Select a tube from the current lot of reticulocyte reagent that will be used for
the days testing.
2. Label the tube RETC_Background and record the current date on the tube.
3. Select the RETIC test selection in the Next Open Tube Entry (NOTE)
region, then select the Ok button to run the Reticulocyte Method Startup
script.
4. Verify that the Analyzer Status indicates Ready state, and select
RETC_Background from Specimen ID QCID drop down menu in the Next
Open Tube Entry (NOTE) region.
5. Open the tube labeled RETC_Background and immerse the Open Sample
Aspiration Probe in the reagent.
6. Press the Touch Plate located behind the probe to start the cycle. The BUSY
indicator light will be illuminated in yellow on the Analyzer Status Indicator
Panel. The Analyzer Status region will display messages indicating the
various stages of the cycle.
12-16
Section 12
7. Remove the tube when the beep sounds. The Wash Block will move down the
probe and clean it.
8. When the cycle is complete, the Wash Block moves back to the top of the
probe and the Ready state will display in the Analyzer Status region.
9. The Run View and Datalog, RETC tab view displays the
RETC_Background (RBGD) count results.
10. Verify that the RETC_Background count is within the acceptable limit of less
than or equal to 100 counts.
NOTE: Results that are outside the acceptable range are displayed in
purple.
11. If the RETC_Background count is unacceptable, repeat it. If the repeated
count is still unacceptable, follow the directions for troubleshooting
RETC_Background count problems given in Subsection: Maintenance and
Troubleshooting later in this section.
Quality Control
Quality control checks should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratorys
protocol. Always mix and handle commercial control materials according to the
directions given in the package insert. Proper mixing is essential for accurate
results. Patient reticulocyte controls should be run and handled according to the
laboratorys protocol. See Section 11: Quality Control, Subsection: QCID File
Setup, for details on customizing the Quality Control ID (QCID) files.
PROCEDURE: QUALITY CONTROL
1. Always mix and handle commercial control materials according to the
directions given on the package insert. See Subsection: Quality Control
Guide, Mixing and Handling, later in this section.
2. Verify that the reticulocyte reagent vial is not expired before use. Store the
stock reagent in the dark at room temperature.
3. Label one tube of reticulocyte reagent for each level of control material.
4. Pipette 20 L of the control material into each labeled tube of reticulocyte
reagent.
5. Incubate the prepared control specimens for 15 minutes, on the rotator or in
a rack, after fully inverting the stained specimens 5 times. Incubation is
performed at room temperature according to the reagent package insert.
NOTE: The stained control specimens may incubate for up to 30 minutes
maximum prior to processing on the CELL-DYN Ruby System.
6. Verify that the RETIC test selection is displayed in the Next Open Tube
Entry (NOTE) region. For instructions on enabling the Reticulocyte
Package, refer to Subsection: Enabling Reticulocyte Processing.
7. Enter the reticulocyte QCID in the Specimen ID QCID field of the NOTE
region or select the QCID Lookup icon to display the list of available
reticulocyte QCID files to choose from.
12-17
Routine Operation
Section 12
8. Open the well-mixed, prepared control specimen tube and immerse the Open
Probe in the sample.
indicator light on the Analyzer Status Indicator Panel will be illuminated in
yellow. The Analyzer Status region will display messages indicating the
10. Remove the tube when the beep sounds. The Wash Block moves down the
probe and cleans it.
11. When the cycle is completed, the Wash Block moves back to the top of the
probe. Wait for the Ready state to display in the Analyzer Status region.
12. Repeat steps 7 through 11 for all prepared control specimens.
13. Verify that the control results are acceptable.
NOTE: Out-of-range results are displayed in color. Data invalidating alerts,
such as Fragile RBC, are not valid when running commercial
controls.
14. If the results are unacceptable, repeat the run. If the results are still
unacceptable, run the other levels of the control material. If the results are
still unacceptable, prepare another stained dilution of that level of the control
material. If the results on all levels are unacceptable, troubleshoot
accordingly. See Subsection: Maintenance and Troubleshooting.
15. When the control results are acceptable, patient samples may be analyzed.
Patient Specimens
A fresh non-hemolyzed, whole blood specimen collection in K2EDTA is the
specimen of choice for Reticulocyte analysis on the CELL-DYN Ruby System.
Specimens may be run up to 8 hours after collection time when stored at room
temperature.
PROCEDURE: RUNNING PATIENT SPECIMENS
1. The prepared dilution(s) of the patient reticulocyte sample(s) can be run after
the control and RETC_Background count results have met the laboratorys
criteria.
2. Wand or enter the Specimen ID in the Specimen ID QCID field of the
region. If a specimen ID match is found in the Pending Orders, the specimen
demographics from the order are sent to the Next Open Tube Entry
(Detailed) dialog box. If there is no match found, the operator can select the
More Spec Info button to enter specimen demographics.
3. The patient demographic data can be added or edited in this dialog box before
the specimen is run, or using F4 Edit from the Datalog after the reticulocyte
run is complete.
4. Select F12 RBC Source to open the RBC Source Selection for
Reticulocyte Absolute dialog box.
12-18
Section 12
5. Choose the RBC source and select the OK button.

If the Specimen ID displayed is more than 8 hours old or none is found, the
RBC value can be entered by the operator.
6. Open the well-mixed, prepared reticulocyte specimen tube and immerse the
Open Probe in the sample.
indicator light on the Analyzer Status Indicator Panel will be illuminated in
yellow. The Analyzer Status region will display messages indicating the
8. Remove the specimen tube when the beep sounds. The Wash Block moves
down the probe and cleans it.
9. When the rinse cycle is complete, the Wash Block moves up the probe. Wait
for the Ready state to display in the Analyzer Status region.
10. The results of the reticulocyte run are displayed on the Run View and
Datalog, RETC tab views.
11. If automatic report printing has been specified, a report is printed according
to the graphs and limits report options selected in the Customize Printed
Report dialog box. If automatic report printing has not been specified, a
report may be printed by pressing F1 Print. Repeat this procedure for each
subsequent reticulocyte specimen.
12-19
Section 12
Routine Operation
NOTES
12-20
Section 12
Quality Control Guide

The CELL-DYN Ruby System offers several quality control options to monitor
and validate instrument performance while running the Reticulocyte Package. The
options are:
QCID Files
Quality Control ID (QCID) file statistical and

graphical analysis of the data in each file to
calculate the mean, standard deviation, and
coefficient of variation
Westgard Rules
A multi-rule system applied to the data in

each of the QC files
Monitors population statistics to detect

changes in the Systems optical measurement
process
Each of these options is discussed in detail in Section 11: Quality Control.

All QC data should be reviewed according to your laboratorys protocol.
12-21
Section 12
Whole Blood Quality Control Run View Chartable Page
Control Material
See Appendix A: Parts and Accessories for the list of available controls for use
on the CELL-DYN Ruby. These controls should be run:
After daily start-up procedures are completed
After a reagent lot number change
After maintenance, component replacement, or a field service action
After a software change
Following calibration
According to your laboratorys quality control program
According to regulatory requirements
NOTE: Data invalidating alerts, such as Fragile RBC or ERL, are not valid
when running commercial controls.
12-22
Section 12
Mixing and Handling

CAUTION: When using the reticulocyte reagent, avoid contact with skin
and clothing. This reagent contains New Methylene Blue, which will stain
skin, clothing, and many other surfaces.
Reagent
Use Reticulocyte Reagent manufactured only by Abbott Laboratories. Verify
the expiration date.
Store the Reticulocyte Reagent in the dark at room temperature.
Use one Reticulocyte Reagent tube for each CELL-DYN control or patient
specimen.
Quality Control Specimens

Always mix and handle commercial control material according to the directions
given in the package insert. Pay particular attention to the following:
Store the CELL-DYN controls in the refrigerator at 2 8 C. Store in a
suitable location in the refrigerator, away from the door if it is opened
frequently.
Carefully warm the CELL-DYN controls prior to mixing, according to the
directions given in the package insert. Proper mixing is essential for accurate
results.
Mix the CELL-DYN control vials gently by hand to thoroughly resuspend
the control material. Do not use automatic mixers to resuspend the control
material.
Check the open-vial stability dating given on the package insert and do not
use the products longer than is recommended or results may be
compromised.
12-23
Section 12
NOTES
12-24
Section 12

Overview
This section provides instructions for identifying, troubleshooting, and correcting
instrument system information messages and conditions in the Reticulocyte
Package. These instrument conditions may be found in Section 10:
Troubleshooting and Diagnostics.
This section is divided into the following subsections:
Maintenance
General Guidelines for Reticulocyte Troubleshooting
Instrument Alert Messages
Instrument Alert Messages with Suppressed Reticulocyte Results
Data Invalidating Alerts
High RETC_Background Counts
NOTE: For a list of interfering substances, refer to Subsection: Interfering
Substances.
Maintenance
A list of scheduled and nonscheduled maintenance procedures can be found in
Section 9: Service and Maintenance, Subsection: Recommended Service
and Maintenance Schedule.
It is recommended that the scheduled maintenance activity 6008 Extended AutoClean be performed on a weekly basis when a laboratory is running the
Reticulocyte Assay.
General Guidelines for Reticulocyte Troubleshooting

Reticulocyte troubleshooting should include an initial check of the following
items:
Reagent storage conditions and expiration. (Refer to the Reticulocyte
Reagent package insert for details).
Sample preparation technique including pipetting, mixing, and incubation.
(Refer to Subsection: Specimen Preparation.)
12-25
Section 12

The result of each run (patient, control, or RETC_Background) is reviewed within
the appropriate limits as entered by the operator or taken from the instruments
preset limits. If a result for a parameter exceeds these limits, they are flagged on
the screen and on the printed report. Dispersional Data Alerts are displayed or
printed as follows:
Screen Display:
Result(s) below lower limits shown in yellow
Result(s) above upper limits shown in purple
Analytical Measurement Range Exceeded: Result displayed as >>>> (See
Table 4.13)
Printed Report:
Result(s) outside limits underlined

when printed

Instrument System Information Messages are displayed when the instrument
detects an inappropriate condition during specimen processing. When necessary,
data is suppressed. When these messages occur, follow the instructions given and
take the appropriate corrective action. When the problem is corrected, repeat the
specimen.
Instrument Alert Messages with Suppressed Reticulocyte Results
Suppression of Reticulocyte results occurs when the sample run data acquisition
process exceeds normal parameters. When the Reticulocyte results are suppressed,
one of the following three alerts will be displayed in the lower left-hand quadrant
of the Run View and on the graphics printout under the heading ALERTS.
Table 12.2

Alert
Probable Cause
Flow Error
Alert occurs when the
average count rate rapidly
increases during the
Reticulocyte count cycle.
Air bubble
Hardware malfunction
1 Run a RETC_Background count to cycle air

through the system.
2 Rerun the Reticulocyte specimen.
3 If alert still occurs, refer to Section 10:
Troubleshooting and Diagnostics,
Subsection: Troubleshooting Tips and
Techniques.
>>>>
The Reticulocyte
percentage exceeds
the analytical
measurement linear
range.
Verify Reticulocyte results by an alternate

method.
12-26
Corrective Action
Section 12

The Reticulocyte results are not suppressed for the Data Invalidating Alerts. The
alert message appears in the lower left-hand quadrant of the Run View and on the
graphics printout under the heading ALERTS.
Table 12.3

Alert
Probable Cause
Corrective Action
Air bubble
Staining a fragile RBC
specimen too long in the
reticulocyte reagent
Fragile RBC
1 Run a RETC_Background count to cycle

the system. Rerun the Reticulocyte
specimen.
2 Prepare another dilution verifying proper
specimen preparation as discussed in
Subsection: Specimen Preparation.
Run the dilution after adequate incubation
as indicated in the Reagent package
insert.
3 Verify Reticulocyte results by an alternate
method.
Excessive RBC Loss (ERL)
Specimen staining time

too long in the
reticulocyte reagent
Rapid degeneration of
RBC
High concentration of
platelets, platelet
aggregates, or other
interfering substances
Microcytic RBC
Improper instrument
settings
1 Prepare another dilution verifying proper

Subsection: Specimen Preparation,
and run after adequate incubation as
indicated in the Reagent package insert.
2 Rerun the specimen.
3 If the flag persists, verify the reticulocyte
results by an alternative method.
Too Few Events

Alert occurs when fewer than
3000 events are counted
during the Reticulocyte count
cycle.
Inadequate whole blood

sample mixing
Improper pipetting
Blood not stained
Cold Agglutinin
Prepare another dilution verifying proper

Subsection: Specimen Preparation within
this chapter.
Verify Reticulocyte results by an alternate
method.
Fragile RBC
NOTE: Alert occurs when

the average count
rate rapidly
decreases during
the Reticulocyte
count cycle.
12-27
Section 12
High RETC_Background Counts

NOTE: The RETC_Background count should be less than or equal to 100 counts.
1. If the RETC_Background count is high, repeat the run.
2. If the results are still unacceptable, open a new tube of reticulocyte reagent
and repeat the RETC_Background count.
3. If the RETC_Background count is still unacceptable, run a tube from a new
lot of reticulocyte reagent if available.
4. If the results are still unacceptable, press the Touch Plate to cycle air through
the system.
5. If the results are still unacceptable, exit the Reticulocyte Package and
perform a routine background check. If these results are acceptable, repeat
the RETC_Background count and if the RETC_Background count is still
high, perform Extended Auto-Clean procedure (see Section 9: Service and
Maintenance, Subsection: 6008 Extended Auto-Clean.)
6. If the routine background count is unacceptable, see Section 10:
Troubleshooting and Diagnostics, Subsection: Troubleshooting Tips and
Techniques.
12-28
Section 12
References
1. NCCLS. Methods for Reticulocyte Counting (Automated Blood Cell
Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline.
NCCLS document H44-A2 (ISBN 1-56238-527-5). NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, 2004.
2. NCCLS. Method Comparison and Bias Estimation Using Patient Samples;
Approved Guideline. NCCLS document EP9-A (ISBN 1-56238-472-4)
NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2002.
3. NCCLS. Evaluation of the Linearity of Quantitative Analytical Measurement
Procedures: A Statistical Approach; Approved Guideline. NCCLS document
EP6-A (ISBN 1-56238-498-8) NCCLS, 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898, 2003.
4. International Committee for Standardization in Haematology (ICSH). The
Assignment of Values to Fresh Blood Used for Calibrating Automated Cell
Counters. Clinical and Laboratory Hematology 1988; 10:203-212.
5. Clinical Applications of Flow Cytometry. ASCP National Meeting. Spring
1990.
6. Shapiro, Howard. Practical Flow Cytometry. New York: LISS. 1985.
7. US Department of Labor, Occupational Safety and Health Administration,
29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens.
9. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory
Third Edition. CLSI document M29-A3 (ISBN 1-56238-567-4). CLSI, 940
12-29
Section 12
References
NOTES
12-30
Appendix A Parts and Accessories
Appendix A
Appendix A - CELL-DYN Ruby Parts

and Accessories
List numbers are unique identifiers that are used when ordering products. The list
number and quantity provided in Appendix: A Parts and Accessories are intended
for guidance only and are subject to change. Contact your Abbott representative for
the most current information regarding list numbers.
Table A.1
CELL-DYN Ruby Hardware List Numbers
List Number
Includes
Name
Comments
08H67-01
CELL-DYN Ruby Analyzer
07H40-02
Bar Code Reader, Hand-Held,

Trigger Activated
Includes Hand-Held Bar Code

Reader Users Guide
05H00-02
Display, Flat Panel
17 inch
08H14-01
Keyboard
Standard - (Flex style),

English
07H96-01
Keyboard
Standard, English
09H41-01
Mouse
Pointing Device
08H07-01
Printer, Graphics (color laser with

USB port connector)
110 VAC
08H07-02
Printer, Graphics (color laser with

USB port connector)
220 VAC (Sourced locally)
08H78-15
Printer, Graphics (Color deskjet

with USB port connector)
100-240 VAC
08H78-16
Printer, Graphics (Color deskjet)

100-240 VAC with USB port
connector
100-240 VAC
08H60-04
OKI B4600 110V Printer
Mono Laser Printer (110V)
08H60-05
OKI B4600 220V Printer
Mono Laser Printer (220V, Sourced

locally)
Item included in Accessories kit.
A-1

Appendix A
Table A.2
CELL-DYN Ruby Accessories Kit (List Number 09H04-01)
Part/List
Number
Quantity
Name
Description
5406753
Allen Wr, Hex, Short L, 3/32
For maintenance
8952087701*
Cable, Data Station (HSSL)
For communication between Data

Module Computer and Analyzer
09H00-01
Cable, (printer), 10'
USB A/B
8240051601*
Cable, Power, 6'7"
For Analyzer
06H92-01
1 pkg
Diluent/Sheath Filter (Pkg of 6)
Millipore filter for Diluent/Sheath

pathway
N/A
Mixing and Handling Inserts
09H06-01
Needle, SL
03B96-02
Paper (printer)
21704-01
Plug, Dummy Waste
For disabling waster sensor when

waste is routed to external drain
03H96-01
1 pkg
Ring, Pull Solenoids
Ring for Pulling Solenoid Valves
92532-01
Serial Loop-Back Device (RS232)
For testing the Laboratory

Information System (LIS)
3106545*
Tubing (120" roll)
Tygon Tubing (1/4" ID, 3/8" OD)
09H38-02
Tubing, Reagent WBC Lyse
Includes reagent container cap,

and sinker (4.0 L container)
92376-01
1 pkg
Tubing set, Transfer Pump
Package of one Transfer Pump

Tubing Assembly
09H41-01
Mouse, Digital USB
Optical Mouse
07H40-02
Bar Code Reader, Handheld,

Trigger Activated
08H43-01
Tubing, Diluent/Sheath
Includes reagent container cap, and

sinker (20L container)
08H41-01
Tubing, HB Lyse
Includes reagent container cap, and

sinker (4L container)
02H96-01
Tubing, Waste Outlet
Includes reagent container cap and

sensor
Closed Mode Needle, for use with

CELL-DYN Ruby
* Orderable by Abbott Personnel only.
A-2
Appendix A
Table A.3
CELL-DYN Ruby Optional Accessories
Part/List
Number
Quantity
Name
Description
07H67-02
Cap (large), Reagent line tubing
For the 3.8 and 20L containers
99650-01
Labels, Tube ID Bar Code, 1 roll
Tube ID Bar Code Labels (1000

labels per roll)
99652-01
Labels, Bar Code, Q-Labels
QC Bar Code Labels (numbered 120), in Code 39 (without check digit)
09H31-02
Labels, Bar Code, Background
Background Bar Code Labels
06H62-01
Labels, CELL-DYN Rack Bar

Code, set of 100
Bar Code Labels for Sample Loader

Racks (#s 0-99)
06H64-01
CELL-DYN Shear Valve Center

Section
Ceramic Center Section for

CELL-DYN Blood Shear Valve
04H34-01
Syringe, 10 mL
For dispensing Diluent/Sheath

reagent
28561-01
Syringe, 2.5 mL
For dispensing WBC Lyse or HGB

Lyse reagent
04H40-01
Syringe Kit, 2.5 mL
For dispensing WBC Lyse or HGB

Lyse reagent. Contains syringe with
collar, mounting bracket, and
mounting screws.
28560-01
Syringe, 500 L
For injecting diluted sample into

optical flow cell
99644-01
Enzymatic Cleaner
03B96-02
500/pkg
08H06-01
8 1/2 x 11
Printer Paper
1 Kit
Rack, Autoloader
Set of 10, Standard Autoloader

Racks
09H32-01
Open Mode Probe
Probe for Open Mode
91485-01
1pkg
Tubing Set, Transfer Pump
Package of four (4) Transfer Pump

Tubing Assemblies
A-3

Appendix A
Table A.4
CELL-DYN Ruby Support Documentation List Numbers
List Number
Quantity
Name
Description
08H56-03
Manual, Online Operators,

CELL-DYN Ruby
CD-ROM
08H56-02
Manual, Operators,
CELL-DYN Ruby
Printed version
09H05-01
Specification, Laboratory Interface,

CELL-DYN Ruby
Specification for communications

between the CELL-DYN Ruby and a
Laboratory Interface System (LIS)
Table A.5
CELL-DYN Calibrator and Controls for use on CELL-DYN Ruby
List Number
Quantity
Name
Description
08H57-01
1 kit
Calibrator, CELL-DYN HemCal

Plus
2, 3-mL tubes with pierceable cap,

insert, and assay sheets
08H58-01
1 kit
Control, CELL-DYN 29 Plus (with

Retic), full-pack (tri-level)
12, 3-mL tubes (4 tubes each of low,

normal, and high control) with
pierceable caps, insert, and assay
sheets
08H58-02
1 kit
Control, CELL-DYN 29 Plus

(with Retic), half-pack (tri-level)
6, 3-mL tubes (2 tubes each of low,

normal, and high control) with
sheets
08H59-01
1 kit
CELL-DYN 26 Plus Tri-Level

Control
12, 2.5 mL tubes, insert, and assay

sheet
08H59-02
1 kit
CELL-DYN 26 Plus HALF-PACK

Tri-Level Control
6, 2.5 mL tubes, insert, and assay

sheet
08H62-01
1 kit
Control, Retic Plus
3.0-mL tubes, levels I and II,

sheet
A-4
Appendix A
Table A.6
CELL-DYN Reagents for use on CELL-DYN Ruby
List Number
Quantity
Name
Single Container Size
Case Weight
QTY/ Case
08H52-01
Reagent, WBC Lyse
3.8 L cubitainer
4.03 .01 kg
1/case
01H73-01
Reagent, Diluent/Sheath
20-L cubitainer
21.9 0.5 kg
1/case
03H80-02
Reagent, CN free HGB/

NOC Lyse
3.8 L cubitainer
4.03 .01 kg
1/case
03H40-01
Reagent, Reticulocyte
5.0 mL tubes, each

tube containing 3.7 mL
of reagent
Kit of 100
A-5

Appendix A
NOTES
A-6
ppendix B Potential Causes of Spurious Results
Appendix B
Appendix B Reference
This table provides a detailed list of potential causes of spurious results
with automated hematology analyzers.
NOTE: Some of the causes listed may not interfere with the
CELL-DYN Ruby parameters. Refer to Section 7: Operational
Precautions and Limitations, Subsection: Interfering Substances
and Conditions , for the list substances and conditions that can affect
the CELL-DYN Ruby parameters.
Table B.1
Potential Causes of Spurious Results with Automated Cell Counters
Parameter
Causes of Spurious Increase
Causes of Spurious Decrease
White Cell Count

(WBC)
Cryoglobulin, cryofibrinogen
Heparin
Monoclonal proteins
Nucleated red cells
Platelet clumping
Unlysed red cells
Clotting
Smudge cells
Uremia plus immunosuppressants
Red Cell Count

(RBC)
Giant platelets
Elevated white cell count
(> 30,000/L)
Cold agglutinins
Clotted specimen (microclot)
Hemolysis (in vitro)
Polycythemia (increased RBC coincidence)
Microcytic red cells
Hemoglobin (HGB)
Carboxyhemoglobin (> 10%)

Hemolysis (in vivo)
Elevated white cell count
(> 30,000/L)
Hyperbilirubinemia, severe Lipemia
Abnormal plasma proteins
Clotted specimen (microclot)
Hematocrit (Packed
Cell Volume - Manual
Method)
Hyponatremia
Plasma trapping
Excess EDTA
Hypernatremia
Mean Cell Volume
Autoagglutination
High white cell count (> 50,000/L)
Hyperglycemia
Reduced red cell deformability
Swollen red cells
Giant platelets
B-1

Appendix B
Appendix B Reference
Table B.1
Potential Causes of Spurious Results with Automated Cell Counters (Continued)
Parameter
Causes of Spurious Increase
Causes of Spurious Decrease
Mean Cell
Hemoglobin

Spuriously high hemoglobin
Spuriously low red cell count
Spuriously low hemoglobin

Spuriously high red cell count
Mean Cell
Hemoglobin
Concentration
Autoagglutination
Clotting
Hemolysis (in vivo and in vitro)
Spuriously high hemoglobin
Spuriously low hematocrit

Spuriously low hemoglobin
Spuriously high red cell count
Platelets (PLT)
Hemolysis (in vivo and in vitro)
Red cell inclusions
White cell fragments
Clotting
Giant platelets
Heparin
Platelet clumping
Platelet satellitosis
SOURCE:
Cornbleet, J. Spurious Results from Automated Hematology Cell Counters. Laboratory Medicine, 1983.
August 14: 509-514.
B-2
Index
Index
A
Access Rights 2-9, 2-45, 2-46, 2-47

Analysis
Closed Mode 5-31
Enzymatic Cleaner 9-30
Open Mode 5-30
Specimen Analysis Tasks 5-13
Task 5-11
Analyzer 1-7
Analyzer failed to prime 10-16, 10-78
Anticoagulants 4-5, 7-6
Recommended 4-5
As-Needed Service and Maintenance 9-4
Aspiration 1-15, 8-12
Bar Code 5-17
cleaning 9-34, 9-37, 9-59, 9-71
Closed 3-1, 5-13
disposal 8-12
Enzymatic Cleaner 9-16, 9-30
Incomplete 5-34, 10-7, 10-11, 10-17
Normal Volume 4-5
Open 3-1, 5-13
Open Tube Mode Aspiration Probe
(Open Mode Probe) 1-9
(with Wash Block) 1-12, 8-12
Sample 3-1, 6-1
Sampling error 5-34, 10-7
Tower 10-40, 10-48, 10-49, 10-77
Vent needles 8-12
Aspiration Volume Specification 4-5
Assistance, Telephone i, 10-1
ATYPDEP 2-9, 2-66, 3-36
Auto Background counts 5-8, 5-15, 7-3, 9-16,
10-5
Auto-Calibration Wizard 5-22, 6-22
Autoloader
Specimen tube dimensions 7-6, 10-20
Automatic Backup 5-40
Background
Counts, on demand 5-16
High Retic 12-28
RETC_Background 12-15
Troubleshooting 10-5
Backup
Configure 5-40
Media 5-40
Bar Code
characters 4-8
codes: Code 39, Code 128, CODABAR,
Interleaved 2 of 5, and ISBT
formats 1-12
ID 5-15, 5-22
match 5-22
match by bar code label specimen ID 5-19
part numbers A-3
Pending Orders 5-20
placement 5-18, 5-31, 9-17
reader 1-6, 1-12, 1-22, 1-23, 1-28
setup 2-9, 2-42, 2-57
Specimen Identification 1-5, 4-8, 5-18
Bar Code Labels See also Bar Codes
Placement 4-9
Bar Code Reader Window 9-32
cleaning 9-32
dialog box 6051 9-33
Bar Code Symbol Dimensions & Label
Requirements 4-7
Bar Codes See also Bar Code Labels
Symbologies
Codabar 4-7
Code 128 4-7
Code 39 4-7
Interleaved 2 of 5 4-7
Bar Codes See also Bar Code Labels
Symbologies
Codabar 4-8
Code 128 4-8
Code 39 4-8
Index-1
Index
Interleaved 2 of 5 4-8
C
Calibration Bias Wizard 6-65
Calibration Overview 6-1
Calibration overview 6-1
Overview 6-1
Change Demographics 5-28
Clearance Requirements 4-4
Closed Mode Analysis 5-31
Code 128 1-12, 4-7
Collection Tubes
Dimensions (Closed Mode) 4-5
Handling 7-6
Minimum Volume 4-6, 7-6
Recommended Anticoagulants 4-5
Components 1-7
Computer 1-22
Creating Annotations 5-53
Creating Rules 5-53
Customer Service i
D
Data Flagging 3-1, 3-19, 3-23, 3-33, 12-26
HGB 3-23
Patient Specimen type 3-33
Platelet 3-21
RBC 3-21
Reticulocyte 12-26
WBC 3-19
Data Invalidating Alerts 3-31, 12-18, 12-22,
12-27
Datalog View 1-35, 2-8, 2-30, 5-20, 5-26,
5-33, 5-36, 5-39
CBC+NOC test 3-5
Customize data view 2-31
Operator ID 5-14
operator ID 5-15
Results 3-6, 3-15
tests 3-5
Datalog View Displays 5-19
Decontamination 8-8, 9-65
Spill Clean-Up 8-7
Index-2
Demographics 5-13
Change 5-28
Edit 5-38
NOTE 1-41, 12-17
Pending Order 5-18, 5-22
Storing data 5-28
Diluent/Sheath 1-16, 1-43
Filter 9-27
Syringe 1-14, 1-16
Dilution Ratios 3-3, 3-4
Dilution ratios 3-4
Dimensions
Physical Specifications 4-3
Disclaimer
Instrument ii
Result Interpretation 7-8
Dispersional Data Alerts 12-26
E
Edit 11-31
Electronic Monthly Archive 5-43
Enzymatic Cleaner 9-16
Event Log 9-10
F
F10LIS Function Key
F10 2-62
Fault Condition
Analyzer 9-54
Fault Conditions 3-27
Analyzer 9-55, 9-56, 9-57, 9-58
System Messages 10-3
Flagging
Interfering Substances 7-8
Flagging Messages 3-27, 10-3
Flags - Suspect Parameter 3-32
Fragile WBCs and Resistant RBCs 3-5
Instrument generated 3-1
Messages 3-29
Floppy Disk Drive 1-10
Flow Cell Assembly 1-18
Flow Error 3-31, 5-33, 12-26
Index
Formats, Bar Codes, See Symbologies, Bar

Codes 4-7
Fragile WBCs 3-5
Front Panel 1-8, 1-10
Function keys
F1 5-20
F12 5-8
F9 1-40
G
Groups View 1-37, 2-8, 5-27, 5-47, 5-48
Customizing view 2-8
Delete 5-49
F6 - Create Order 5-25
Manually deleting records 5-48
Reorder 5-26, 5-39
Guidelines for Specimen Collection 4-6, 7-6
H
Hazards
Biological 8-5
Chemical 8-7
Electrical 8-8
Icons, Safety 8-2
Mechanical 8-10
Physical 8-12
Safety Icons 8-2
HCT calculation 3-21
Heat Output Specifications 4-4
Heaters, Reagent HGB 1-15
Heaters, Reagent WOC 1-15
Helium 3-8
helium 3-8
Helium Neon Laser 3-10, 3-19
Help, Telephone i
Hemoglobin 1-44
Hemoglobin Analysis 3-6
HGB Flow Cell 1-15
High Background Counts 10-5
High Retic Background 12-25, 12-28
Histograms - WBC 3-17
Host Query 2-64
HSSL Connector 1-23
Humidity Specification 4-4
hydrodynamic focusing 3-9
I
Icon, Safety 8-2
Identification
Bar code reader 1-28
QC Download ID File Setup 11-59
Specimen 5-18
Bar Code Specifications 4-7
Incomplete aspiration 5-34, 10-7, 10-11, 10-17
Incubate 12-15
Incubation time limit 12-15
Installation 2-3
Site Requirements 2-1, 2-3
Instrument and Data Invalidating Alerts 3-31
Instrument Disclaimer ii
Intended Use 1-2
Interfering Substances 3-20, 5-17, 7-8, 12-14,
12-25, B-1
Reticulocytes 12-11, 12-14
Spurious B-1
Suspect population flags 3-32
Interfering Substances and Conditions 7-8,
12-14
Interruption
Procedure, Sample loader 5-9
L
Labels
Instrument x
Laser Caution 8-3
Levey Jennings View 11-36
Levey-Jennings View 11-22
Light scatter 1-44
Limits
Action 2-8
Background counts 5-4, 6-12, 12-15
Customize 2-11
Lower and Upper 2-8
Means 2-8
Patient Sample Setup 2-7, 2-10, 3-32
QC 2-8, 2-39, 11-30
Reports 2-8, 2-35, 2-39
LIS
pending order entries 5-22
LIS Setup 2-9, 2-62
Index-3
Index
Accessing the LIS Setup dialog box 2-62
Logs
Calibration 9-9
Event 9-10
Maintenance 9-8
Reagent Log 9-13
Set Point 9-11
Logs Auto Backup Setup 2-67
M
Main Power Cord 1-14
Main Power Switch 1-19
Maintenance
Maintenance log 1-37
non-scheduled 9-75
Scheduled 1-42, 9-4
Maintenance Log 1-42, 9-8
Maintenance View 9-6
MCH calculation 3-21
MCHC calculation 3-21
MCV calculation 3-20
Media
external 5-40
Minimum Volume 4-6
Mixing Station 1-12, 5-17
Moving Average 1-36, 2-8, 11-34
Acceptance Setup 11-60
Levey-Jennings View 11-36
MPV calculation 3-22
N
New Methylene Blue N 12-3
Noise Level Specifications 4-4
Nominal Aspiration Volume 4-5
Normally Closed Valves 1-14, 1-16, 5-5, 9-64
Tubing 9-67
NOTE Region 1-40, 5-24
Nuclear Optical Count 3-5
Index-4
O
Online PDF Documentation
Access
Stand Alone Computer 14
Open 5-13
Open Mode analysis 5-30
(Open Mode Probe) 1-9
(with Wash block) 1-12
Open Tube Mode Aspiration Tube Probe 1-11
Operating Environment Requirements 4-4
Operational Messages 3-27
Interfering Substances and Conditions 3-16,
5-17, 7-8, 12-14, 12-27
Operational Specifications 4-5
Operator ID
running background counts 5-15
signing on and off 5-15
Operators 2-9, 2-38
Access levels 2-38
Adding 2-41
Edit operator info 2-44
Editing permission rights 2-45
Factory set limits 2-11
Removing 2-42
Second Sign On 2-48
Set permissions 2-45
Optical Bench Assembly 3-8
Optical Flow Cell 3-9
Orders 1-35
Orders Setup 2-9, 2-59, 2-60, 5-22, 5-23, 5-25
Bar code mismatch 10-25
QCID mismatch 10-25
Orders View 1-5, 1-35, 5-20, 5-22, 5-23, 5-24,
5-48
Closed 3-1
Pending Orders 5-20
Orders View Customization
default match criteria 5-20
Default Patient Test Selection 5-20
Index
Parameter Set 2-7, 2-25, 2-26

Parts and Accessories A-1, B-1
Patent Statement ii
Patient Test Selection 5-21
Pending Orders
Closed Mode 5-18
Open Mode 5-24
originating from 5-22
Performance Specifications 4-11
Peristaltic Pump vi, 1-14, 9-15
Sample transfer 1-14, 8-11
Tubing 9-20, 9-21
Wheel 9-20
Permission 2-9, 2-45
Editing rights 2-46
Laboratory I and II 2-38, 2-39
PLT 1-15, 1-16
PLT calculation 3-22
PLT Messages 3-40
Power
Off 5-6
On 5-3, 9-69
Specifications 4-3
Preparation for Shipment 8-8, 9-60
Preparing and Handling Controls 7-4
Preparing and Handling Specimens 7-6
Preparing to run specimens 5-14
Prime 9-7
Prime finished 10-11
Priming 5-3, 5-8, 9-60
2099 Analyzer failed to prime 10-78
analyzer 9-54, 10-3, 10-16
fatal fault 10-3
Prime finished - auto bkg to follow 10-11
Printing
Summary report of Pending Orders 5-20
Procedure
Background Count 12-16
Quality Control 12-17
QC Limits 2-8, 11-30

edit 11-31
Setup 11-29
tab 11-43
QC View 1-36, 2-8, 11-10, 11-13, 11-22,
11-23, 11-64
Bar and Buttons 11-16
column headings 11-14
Customize 2-30
customize 12-7
Editing a QC specimen run 11-65
Function keys 11-16, 11-20, 11-22, 11-35
Main 11-14
Moving average 11-35, 12-1
Operator ID 5-15
QC Data 11-59
QC Info tab 11-15
QCID L-J Plots 11-22
Tab views 11-14
View QC Spec 11-17
QC Views 11-9
QCID 11-18, 11-25
QCID Files
Deleting 11-18, 11-25
Moving QCID Specimen Runs 11-67
Quality Control Guide 12-21
Quality Control Methods 11-3, 12-21
Quality Control Specimens 11-3, 12-23
Quick Precision Check 6-18
R
Rack and Tube position 5-27
Rack and Tube Setup 2-9, 2-59, 2-60, 5-18,
5-22, 5-23, 5-24, 5-26, 5-27, 10-25
RBC 1-15
RBC Count 3-20
RBC Messages 3-39
RBC/PLT Analysis 3-6
RDW calculation 3-21
Reagent 7-4, 8-7
Reagent Heaters
HGB 1-15
WOC 1-15, 3-4
Index-5
Index
Reagent Log 1-37, 5-15, 9-13
Reagent System 1-43
Reagents Heaters HGB 1-15
Reagents Heaters WOC 1-15
Reagents View 9-13
Current Reagents Tab 9-12
Reagents Log tab 9-13
Reagents View function keys 9-13
Reagents, CELL-DYN Ruby
Hazards 8-7
Storage and Handling 7-4
Recommended Anticoagulants 4-5
Refrigerated
specimen stability 5-17
Refrigerator
stored items 5-17
Relocation of System 2-5, 8-8
Relocation 8-8
Report Header 2-8, 2-33, 2-34
Requirements
Waste Disposal 4-4, 8-7
Resistant RBCs 3-5
RETIC Test Selection 12-9
Reticulocyte Package 12-3
Reticulocyte Reagent 12-15, 12-23
Reticulocytes 12-3
Retrieve from file 2-8, 11-47
Run Specimen
required procedures 5-14
Run Specimens 12-15
preparing to 5-14
Run View 5-11, 5-34
Background Counts 5-15
Chartable Page 5-35
Review results 5-30, 5-31
S
Safety
Icons 8-2
Sample
Volume See Aspiration Volume 4-5
Sample Analysis Cycle 3-3
Sample Aspiration 3-1
sample aspiration modes 3-1
Sample Feed Nozzle 1-18
Index-6
Sample Loader 1-5

Bar Code Reader 1-12
Components 1-11
interruption procedures 5-9
mixing 5-18
Specimen Rack 1-13
Specimen Tube Dimensions 4-6, 7-6
Tray 9-16
Sample Loader Components 1-11
Sample Loader Rack 1-13, 5-31
Sample Metering Syringe 3-10
Sample Segments 3-3
Sample Transfer Pump 3-10
SBar Codes See also Bar Code Labels
Symbology 4-7
Schedule, Service and Maintenance 9-3
Screen Navigation 1-32, 11-15
SD (Standard Deviation) 11-7
Second Sign On 2-48
As-Needed 9-4
Nonscheduled 9-4
Scheduled 9-4
Service and Maintenance Schedule 9-3
Setup Demographics 5-13
Setup Guidelines 5-11, 12-7
Sheath Reservoir 1-16, 3-10
Site Requirements 4-4, 7-2
Special Protocols 9-7, 9-51, 9-53
prime the analyzer 9-54
Specifications
Aspiration Volume 4-5
Clearance Requirements 4-4
Collection Tubes Dimensions (Closed
Mode) 4-5
Environmental 4-4
Heat Output 4-4
Humidity 4-4
Noise Level 4-4
Operational 4-5
Performance 4-11
Physical 4-3
Power 4-3
Temperature 4-4
Throughput 4-5
Waste Disposal Requirements 4-4, 7-2
Index
Specimen
Handling 7-6
Specimen ID Validation 2-64
Specimen Identification 7-4
Invalid 4-8, 5-18, 5-19
No ID 5-19
Specimen Preparation 12-15, 12-18
Specimen Requirements 12-11, 12-12
Specimen tube dimensions 7-6
Specimen Tube, Minimum Volume in 4-6
Specimens, preparing and handling 7-6
Analysis 5-1, 5-8, 5-13
collection 5-17
handling 5-14, 7-6
mixing 5-18
preparing 7-6
preparing to run 5-14, 12-11
requirements 5-16
task 5-13
Specimens, running
ID methods 5-19
rack and tube 2-59
Spill Clean-Up 8-7
Spinner Assembly 1-12
Standby procedure
manually 9-7
Status conditions 3-27
Suspect Parameter Flags 3-32
Population 3-32
Symbologies, Bar Code 4-7, 4-8
Syringes - HGB Lyse 1-16
Syringes - Sample Metering 1-16
Syringes - WBC Lyse 1-16
System
Backup features 5-40
System Connection and Start Up Guidelines 2-5
System Information Messages, SIMS 10-4,
10-17
System Messages 10-3, 10-11
System Priming 5-8
System Relocation and Shipping Guidelines 8-8
System View
Calibration Log 9-9
Event Log 9-10
Set Point Log 9-11
T
Technical Assistance i
Telephone Support i
Temperature Specification 4-4
Throughput Specifications 4-5
Trademark Statements v
Transfer Pump 9-64
Tubing 9-20
tube dimensions 10-20
Tube
Tube Racks and Related Components 4-6
Tubes
Sample Loader 1-5
Tube Dimensions 4-5
Tube Racks and Related Components 7-6
Tubes Dimensions 7-6
troubleshooting 10-40
Tubes Sensor Assembly 1-12
U
Ultrasonic Sensor 3-1
Unpacking and Inspection Guidelines 2-4
V
Viewing Archived Data 5-46
Views
Datalog 1-35, 1-42, 2-8, 2-30
Maintenance 9-6
Orders 5-20
QC View 1-36, 1-42, 2-8, 11-9, 11-13
Reagents 9-12
Run 5-31
System 9-9
Volumes
Minimum Volume in Specimen Tube 4-6
Nominal Aspiration Volume 4-5
Index-7
Index
W
Warranty Statement for USA Customers Only iv
Waste 1-15
Waste Disposal Requirements 2-4, 4-4, 8-7
Waste disposal requirements 4-4
WBC 1-44
WBC Analysis 3-4
WBC Lyse 1-44
Index-8
WBC Messages 3-39

WBC Mixing Chamber 1-14, 1-15, 1-16, 1-44,
3-4, 3-10
Westgard Rules 1-39, 2-8, 2-37, 5-1, 10-19,
11-1, 11-3, 11-9, 11-11, 11-29, 11-30,
11-31, 11-44, 11-49, 11-50, 11-54, 11-56,
11-69, 11-72, 11-73, 12-1, 12-21

CD Ruby Operator Manual 08H5602

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Operators Manual

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CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

the copyright notice appears on all copies;

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

CELL-DYN Ruby System Operators Manual

Warranty Statement for USA Customers Only

CELL-DYN Ruby System Operators Manual

Regulatory and Safety Agency Approvals

CELL-DYN Ruby System Operators Manual

HGB Flow Cell

CELL-DYN Ruby System Operators Manual

Cyanide-Free Hemoglobin/Nuclear Optical Count Lyse Reagent

Red Blood Cell

CELL-DYN Ruby System Operators Manual

(Example shows Store at 28C)

White Blood Cell

CONTROL ASSAY FILES

Control Assay Files

CONTROL I/II/III or L/N/H

Control, Level I, II, or III or Level L, N, or H

CELL-DYN Ruby System Operators Manual

Authorized Representative in the European Community

Consult Instructions for Use

In Vitro Diagnostic Medical Device

CELL-DYN Ruby System Operators Manual

Analyzer Rear Panel

Class 1 Laser Product Label

CELL-DYN Ruby US Patent Label

CE Mark and Legal Manufacturer

CELL-DYN Ruby System Operators Manual

ETL Certification Label

Analyzer Right Flow Panel

ABBOTT DIAGNOSTICS DIVISION

THIS PRODUCT COMPLIES WITH FDA

Manufactured for Abbott Laboratories

CELL-DYN Ruby System Operators Manual

Analyzer Serial Number Labels

Analyzer Left Flow Panel

CELL-DYN Ruby Service Technical Service Bulletin Record Label

CAUTION Class 3B laser light when open. Avoid

Laser Warning Label

Analyzer Front and Rear

CELL-DYN Ruby System Operators Manual

Master Table of Contents

Master Table of Contents

Master Table of Contents-1

Master Table of Contents

Analyzer Flow Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Master Table of Contents-2

CELL-DYN Ruby System Operators Manual

Master Table of Contents

Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

CELL-DYN Ruby System Operators Manual

Master Table of Contents-3