ATC 5diff Manual

COULTER ACT 5diff Autoloader Hematology Analyzer
Operators Training Guide
PN 177196BB (August 2012) Manufactured for Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 U.S.A.
WARNINGS AND PRECAUTIONS

READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURERS RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE. HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows: WARNING - Can cause injury. CAUTION - Can cause damage to the instrument. IMPORTANT - Can cause misleading results. BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. WARNING Risk of operator injury if: r All doors, covers and panels are not closed and secured in place prior to and during instrument operation. r The integrity of safety interlocks and sensors is compromised. r Instrument alarms and error messages are not acknowledged and acted upon. r You contact moving parts. r You mishandle broken parts. r Doors, covers and panels are not opened, closed, removed and/or replaced with care. r Improper tools are used for troubleshooting. To avoid injury: r Keep doors, covers and panels closed and secured in place while the instrument is in use. r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors. r Acknowledge and act upon instrument alarms and error messages. r Keep away from moving parts. r Report any broken parts to your Beckman Coulter Representative. r Open/remove and close/replace doors, covers and panels with care. r Use the proper tools when troubleshooting. CAUTION System integrity might be compromised and operational failures might occur if: r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your systems computer with software authorized by Beckman Coulter. r You install software that is not an original copyrighted version. Only use software that is an original copyrighted version to prevent virus contamination. IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.
REVISION STATUS
Issue A, 10/02 Software version 1.00 Issue B, 4/03 Software version 1.10 Issue BA, 5/10 Software Version 1.10. Updates were made to the company corporate address. Issue BB, 08/12 Software Version 1.2.4. Changes were made to: r r r r Section 1.5, ANALYZER > D Topic Notes and Tasks, step 3a2 Removed step 5c under SHUTDOWN PROCEDURE > D Topic Notes and Tasks Carryover Check Refer to the Hematology Tube List on the BCI website
Note: Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page.
This document applies to the latest software listed and higher versions. When a subsequent software version changes the information in this document, a new issue will be released to the Beckman Coulter website. For labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for your instrument.
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REVISION STATUS
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CONTENTS
WARNINGS AND PRECAUTIONS, ii REVISION STATUS, iii CONTENTS, v INTRODUCTION, ix PURPOSE OF THIS DOCUMENT, ix TRAINING RESPONSIBILITIES, ix INSTRUMENT DOCUMENTATION, ix ABOUT THIS TRAINING GUIDE, x CONVENTIONS, xi SAFETY SYMBOLS, xii 1 GETTING TO KNOW YOUR INSTRUMENT, 1-1 1.1 1.2 1.3 1.4 1.5 1.6 2 WORKSTATION HARDWARE, 1-1 WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM, 1-4 PRINTER, 1-9 BAR-CODE SCANNER (OPTIONAL), 1-10 ANALYZER, 1-11 REAGENTS AND INSTRUMENT WASTE, 1-17
STARTUP / SHUTDOWN, 2-1 2.1 2.2 2.3 2.4 2.5 2.6 STARTUP PROCEDURE, 2-1 MINI-CLEAN CYCLE, 2-4 AUTO-CLEAN CYCLE, 2-5 SHUTDOWN PROCEDURE, 2-6 SYSTEM POWER DOWN PROCEDURE, 2-7 SYSTEM POWER UP PROCEDURE, 2-8
SETUP OPTIONS, 3-1 3.1 3.2 3.3 MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, 3-1 QUALITY ASSURANCE SETUP OPTIONS, 3-5 AUTO FUNCTIONS SETUP OPTIONS, 3-7
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CONTENTS
3.4 3.5 3.6 3.7 4
SYSTEM SETUP OPTIONS, 3-9 CONFIGURATION SAVE AND RESTORE SETUP OPTIONS, 3-13 OPERATORS SETUP OPTIONS, 3-14 FLAGGING SETS SETUP OPTIONS, 3-16
QUALITY ASSURANCE, 4-1 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 SETTING UP OR MODIFYING CELL CONTROL FILES, 4-1 ANALYZING CELL CONTROLS, 4-3 INTERPRETING AND USING CELL CONTROL DATA, 4-9 CONTROL DATA MANAGEMENT, 4-13 INTERLABORATORY QUALITY ASSURANCE (IQAP), 4-14 REPRODUCIBILITY AND CARRYOVER CHECKS, 4-15 SETTING UP XB/XM, 4-17 INTERPRETING AND USING THE XB/XM DATA, 4-20
CALIBRATION, 5-1 5.1 5.2 5.3 5.4 CALIBRATION OVERVIEW, 5-1 PRELIMINARY CALIBRATION CHECKS/PROCEDURES, 5-2 AUTO-CALIBRATION, 5-3 MANUAL CALIBRATION, 5-7
SAMPLE ANALYSIS, 6-1 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 SPECIMEN HANDLING, 6-1 SAMPLE IDENTIFICATION, 6-3 PATIENT/SAMPLE INFORMATION, 6-6 WORKFLOW OPTIONS, 6-12 SAMPLE ANALYSIS IN THE AUTOLOADER MODE, 6-14 SAMPLE ANALYSIS IN THE MANUAL MODE, 6-16 RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS, 6-18 AUTOMATIC AND MANUAL SPECIMEN RERUNS, 6-23 MANUAL MATCHES, 6-24
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DATA MANAGEMENT AND REVIEW, 7-1 7.1 7.2 7.3 7.4 7.5 7.6 DATA MANAGEMENT, 7-1 DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS, 7-3 DATA ANALYSIS - MEASUREMENT PRINCIPLES, 7-9 DATA ANALYSIS REVIEW - WBC PARAMETERS, 7-15 DATA ANALYSIS REVIEW - RBC PARAMETERS, 7-21 DATA ANALYSIS REVIEW - PLATELET PARAMETERS, 7-27
SYSTEM DIAGNOSTICS AND MAINTENANCE, 8-1 8.1 8.2 8.3 8.4 8.5 ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS, 8-1 RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION, 8-7 BASIC TROUBLESHOOTING TECHNIQUES, 8-16 SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS, 8-19 PREVENTIVE MAINTENANCE, 8-22
SUMMARY AND QUICK REFERENCE MASTERS, 9-1 9.1 9.2 9.3 SUMMARY PAGES, 9-1 QUICK REFERENCES PAGES, 9-1 CONTENTS, 9-1
TRAINING CHECKLIST, 1 ACCOUNT INFORMATION, 1 PURPOSE, 1 INSTRUCTIONS, 1 CHECKLIST, 1 TRADEMARKS, 1
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CONTENTS
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INTRODUCTION
PURPOSE OF THIS DOCUMENT
This document provides an authorized trainer with corporately accepted training materials for instructing a new Operator in the correct use and operation of a COULTER ACT 5diff Autoloader (AL) hematology analyzer.
TRAINING RESPONSIBILITIES
Beckman Coulters Responsibility
Beckman Coulter is responsible for instructing a Key Operator in the correct use and operation of the ACT 5diff AL hematology analyzer. Our goal is to provide your laboratory with high quality training that best fits your laboratorys needs. This means the emphasis given to each topic in this Training Guide may differ, with some topics needing to be covered more thoroughly than others.
Key Operators Responsibility

It is the Key Operators responsibility to train all other Operators in the laboratory. Once trained by an authorized Beckman Coulter trainer, the Key Operator is authorized to use and make copies of any of the material in this Training Guide as needed for training other laboratory personnel.
INSTRUMENT DOCUMENTATION
The Training Guide is part of a document set provided with your instrument. The Training Guide references the following documents whenever appropriate, to help the trainee become familiar with their contents and to use them as needed. r Instructions for Use, PN 4277367, provides information about the function of the ACT 5diff AL instrument and describes how to: t t t t t t t t Get started using the instrument. Operate the instrument safely. Run controls and samples. Review results. Do special maintenance procedures, such as cleaning, replacing, or adjusting an instrument component. Troubleshoot problems. Power down and power up the instrument. Customize the instruments setup.
The Instructions for Use is accessed using the ACT 5diff AL Online Help system. The printed version is by order. Contact your Beckman Coulter Representative if you want to order a printed copy of this manual.
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INTRODUCTION ABOUT THIS TRAINING GUIDE
Host Transmission Specification, PN 4277065, defines the information needed to program the transmission interface between the ACT 5diff AL hematology analyzer and your laboratorys host computer. The printed version is available by order. Contact your Beckman Coulter Representative if you want to order a printed copy of this manual.
ABOUT THIS TRAINING GUIDE

Scope
This training guide is designed to support ACT 5diff AL hematology analyzer training. It provides the trainer with the opportunity to customize the training experience to best fit the individual trainee and laboratory. Since trainee experience levels and laboratory needs differ, this training outline is designed with flexibility in mind.
Topics
The materials in this guide support the training of eight main topics: r r r r r r r r Topic 1 Getting to Know Your Instrument Topic 2 Startup/Shutdown Topic 3 Set Up Options Topic 4 Quality Assurance Topic 5 Calibration Topic 6 Sample Analysis Topic 7 Data Management and Review Topic 8 System Diagnostics and Maintenance
Each main topic is further divided into several related topics (subjects) that may be included, as needed, in your training. Each of these smaller topics includes four elements:
A Objectives. Lists the objectives the trainee is expected to meet at the completion of the topic. B References. Lists the sections in the customer documentation where the topic is covered. These references can be used by the trainer to prepare for teaching the topic and could be assigned to the trainee as prerequisite or review reading. C Special Instructions. Lists the instrument conditions that must be met, supplies needed
(when applicable), and other tips to the trainer for completing the topic.
D Topic Notes and Tasks. Lists the key facts that should be covered and suggests tasks to
promote or reinforce learning the topic material.
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INTRODUCTION CONVENTIONS
Organization
The eight main topics contained in the Operators Training Guide are part of a larger organization that includes four basic types of information.
Introduction. Describes the format of the Training Guide and how it is meant to be used. Topics (Chapters 1 - 8). This is the heart of the document. It provides the trainer with document references, key facts about the topic, and suggested tasks to help them teach the trainee how to operate the instrument correctly. It can also be used as a review by the trained Operator. It is not, however, designed to be used as a self-study by an untrained Operator. Summary and Quick Reference Pages. Contains master copies of Summary pages and Quick Reference pages for use by the Key Operator in the laboratory after training is completed. Training Checklist. Provides a method for documenting the specific training an Operator
receives.
Summary Pages
Routine operational tasks detailed in the Instructions for Use manual are abbreviated and included in the Training Guide as summary pages. Each summary page is an individual, stand-alone document that is designed for use in the laboratory both as a training aid and as a reference tool for the trained Operator.
Training Checklist
The Training Checklist provides the trainer with an official method to document the completion of training on the ACT 5diff AL hematology analyzer. When the training process is completed, we recommend that both the trainer and trainee sign the Training Checklist to show agreement that the trainee is sufficiently trained on the topic or tasks covered.
CONVENTIONS
This training guide uses the following conventions: r r r Instructions assume Operator is using the mouse for navigation. Click means use the left button on the mouse to select a screen item.
Bold font indicates a software option, such as Startup.
tt between menu items indicates the software path to a specific function or screen, such as Click tt to access the Miscellaneous Setup screen.
r r r
Italics font indicates screen text displayed on the instrument, such as Insert Tube. Information that is to be typed is in Courier font such as type the password 123. indicates a key on the keyboard such as . t t Press indicates the Operator needs to press and release the key. Press + indicates the Operator needs to press and hold the first key listed, then press the next key.
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INTRODUCTION SAFETY SYMBOLS
r r
A Note: (in bold font) prefaces supplemental information. An ATTENTION (in bold font) prefaces information that is important to remember or helpful when doing a procedure. indicates a suggested task for the trainer or the trainee. Instrument or system is sometimes used to refer to the ACT 5diff Autoloader hematology analyzer (meaning both Analyzer and Workstation). AL refers to autoloader. Main card refers to the main circuit board (card) in the instrument. RBC bath is sometimes referred to as RBC/Plt bath. The terms screen and window are used interchangeably. ACT 5diff Rinse reagent is sometimes referred to as Rinse. ACT 5diff Fix reagent is sometimes referred to as Fix. ACT 5diff Hgb Lyse reagent is sometimes referred to as Hgb Lyse. ACT 5diff WBC Lyse reagent is sometimes referred to as WBC Lyse. ACT 5diff Diluent reagent is sometimes referred to as Diluent.
r r r r r r r r r r r
SAFETY SYMBOLS
Safety symbols alert you to potentially dangerous conditions. These symbols, together with text, apply to specific procedures and appear as needed in the Summary pages and before applicable topic task throughout this training guide.
Symbol Warning Condition Biohazard. Consider all materials (specimens, reagents, controls, and calibrators, and so forth) and areas these materials come into contact with as being potentially infectious. Probe hazard. The probe is sharp and may contain biohazardous materials, such as controls and calibrators.
Action
Wear standard laboratory attire and follow safe laboratory procedures when handling any material in the laboratory.
Avoid any unnecessary contact with the probe and probe area. Before continuing, unplug the Analyzer from the electrical outlet. Pay close attention to the information provided when you see this symbol.
Electrical shock hazard. Possibility of electrical shock when instrument is plugged into the power source.
Conditional hazard. Possibility of a hazard based on specific conditions.
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1GETTING TO KNOW YOUR INSTRUMENT 1

1.1 WORKSTATION HARDWARE
A Objectives
When you have completed this topic, you will be able to: B Locate and name the four major components of the computer system. B Locate and explain the function of specific keys on the keyboard. B Explain how to use the mouse to navigate through the software.
B References
1. 2. In the Online Help System or the Instructions for Use manual, refer to Heading 11.10 COMPONENT LOCATIONS. Refer to the Users manual for the monitor for any monitor adjustments.
C Special Instructions
1. 2. The instrument must be powered up. Any screen except the log-in screen can be displayed.
D Topic Notes and Tasks

1. The Workstation is one of four main components in the ACT 5diff AL system. Point out the Analyzer, Workstation, Printer, and the optional Bar-Code Scanner if you have not already done so. 2. The function of the Workstation is to: a. b. c. d. e. 3. 4. 5. Control and monitor instrument operation. Display, store, output, and allow recall of sample results. Store and graph control results for the Quality Assurance program. Automatically calculate new calibration factors. Allow bidirectional communication with a host computer.
You must not use the instruments Workstation as a personal computer. The Workstation hardware refers to the physical components of the computer. Identify the following Workstation hardware: a. b. c. d. Computer Monitor Keyboard Mouse
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GETTING TO KNOW YOUR INSTRUMENT WORKSTATION HARDWARE
6.
The computer houses the software program and communicates with the Analyzer. a. b. c. Point out the power ON/OFF switch and the indicator that lights when power is on. Identify the three drives: the hard drive indicator and symbol, the CD-ROM drive, and the diskette (floppy) drive. Identify the connections on the back of the computer. Note: The computer configuration used in this laboratory may not match the one shown in the Instructions for Use manual.
7.
The computer uses the monitor to display information. a. b. Point out the power ON/OFF switch and the indicator that lights when power is on. Point out the screen adjustment controls. Refer to the Users manual supplied with the computer system to make any adjustments. Determine if the trainee is already familiar with computer keyboards. 1) 2) If the trainee is familiar with computer keyboards, just point out that the keyboard on this instrument is standard. If the trainee is not familiar with computer keyboards: a) b) b. Review the keyboard layout and keys information below. Emphasize hands-on experience on the keyboard during the rest of the training.
8.
The keyboard is the interface between the Operator and the computer. a.
The keyboard shipped with the instrument has a standard layout and keys. 1) Alphanumeric keys: a) b) 2) 3) Are configured in a standard typewriter keyboard layout. Consist of all standard alphanumeric keys plus a handful of special computer keys and symbols.
can a be used to move from field to field on some windows. works like the Shift Lock key on a typewriter. a) b) When it is on, pressing any alphabet key on the keyboard produces an uppercase letter. It only shifts the letter keys; all other keys on the keyboard remain the same. Contains the numbers 0 through 9, plus the period, an key, and various mathematical symbols. Can expedite manual entry of patient ID numbers and certain quality control entries. Locate light that lights when Num Lock is on. When Num Lock is on, the numeric keypad produces numbers. Workstation keyboard is designed to be used with the Num Lock on. When Num Lock is off, the numeric keypad doubles as a cursor keypad.
4)
Numeric keypad: a) b)
5)
controls operation of the numeric keypad a) b) c) d)
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GETTING TO KNOW YOUR INSTRUMENT WORKSTATION HARDWARE
6)
Cursor control keys move the cursor. a) b) c) Arrow keys, , move the cursor bidirectionally, a line at a time. and move the cursor up or down by a full page. and move the cursor to the beginning or the end of a file.
7) 8)
places a space in a line of characters. a) b) Key is used mainly to select a highlighted menu option. Keyboard has two keys; both work identically.
9)
and are modifier keys that have no action by themselves but can be used in conjunction with other keys to initiate special operations.
10) allows you to print whatever is currently displayed on the screen. 9. The mouse is the principle navigation tool on the instrument. a. Determine if the trainee is already familiar with using a mouse. 1) 2) If the trainee is familiar with using a mouse, just point out that with the ACT 5diff AL software, the Operator only uses the left mouse button. If the trainee is not familiar with using a mouse: a) b) b. Using the information below, explain/demonstrate how a mouse works. Emphasize hands-on experience using the mouse during the rest of the training.
When using a mouse for navigation: 1) 2) Moving the mouse on the table top moves the mouse pointer on the screen. Pressing and releasing the left button on the mouse selects whatever is under the pointer, or if in a field on the screen, anchors the cursor in the field. a) b) 3) Pressing and releasing the left button is referred to as clicking. If you are directed to click ( ) an item it means you should move the mouse cursor over that item and press and release the left mouse button.
Placing the cursor on a slider and then pressing and holding the left mouse button allows you to move the slider for as long as you hold down the button.
c.
To see the function name of a specific icon, move the mouse cursor over the icon without clicking the mouse button until the text appears.
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GETTING TO KNOW YOUR INSTRUMENT WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM
1.2
WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM

A Objectives
When you have completed this topic, you will be able to: B B B B B Log out from the Workstation. Log into the Workstation correctly. Locate the Generic toolbar and identify each icon. Locate the Contextual toolbar and identify each icon. Use the mouse to navigate from the Main Menu screen to sub menus.
B Use the tabs, buttons, fields, check-boxes, drop-down menus, scrollable lists, and scroll bars in the Workstation software as needed. B Access and use the Online Help system as needed. B Access and use the Instructions for Use manual.
B References
1. In the Online Help System or the Instructions for Use manual, refer to: r
r Heading 5.5 LOGGING ON (IF SYSTEM IS ALREADY POWERED UP) Heading 5.11 SOFTWARE SCREENS Heading 5.12 MENU PATH Heading 5.13 WORKING WITH THE SOFTWARE Heading 5.10 USING YOUR ACT 5diff AL HEMATOLOGY ANALYZER OPERATOR MANUALS CD-ROM
r
r r
2.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the: r r
SOFTWARE ICONS AND MENUS PATHS QUICK REFERENCE. ONLINE HELP SYSTEM.

1. The Workstation software refers to the sequence of detailed instructions (called a program) that directs the computer to perform certain actions. a. b. The Workstation software is based on the Microsoft Windows-NT operating system. Familiarity with Windows conventions and use is beneficial but not required.
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2.
A login name is required for all users to access the Workstation software program; a password is required for some. a. When the software is first installed, the system is set up with default user names for the three access groups. 1) The Operator group default user name is Opr1. a) The Operator group has the most limited access to the software. They do not have access to setup screens, calibration, or certain service diagnostics. b) Someone in the Operator group does not require a password unless their Supervisor sets the instrument up that way. The Supervisor group default user name is Supervisor. The Supervisor group has access to everything except certain service diagnostics. b) Someone in the Supervisor group must use a password. c) The default password is 123. The Service group default user name is Service. a) b) c) Service has full software access. Someone in the Service group must use a password. The Service group is reserved for Beckman Coulter Representatives and anyone who has completed the Beckman Coulter authorized service training on this instrument. a)
2)
3)
b.
A unique login name for each user is recommended so that instrument events can be traced back to the Operator. 1) Adding users names to the system is part of the instrument setup. 2) If it is not done yet, have the trainee use the default user name and password for the Supervisor group now and set up new users later.
c.
Walk the trainee through logging out and then logging back in using their user name and password. (DO NOT power down at this time.) 1) If any screen other than the Main Menu is displayed, click Menu screen is displayed. until the Main
2) 3)
From the Main Menu screen, click to exit the ACT 5diff AL software. When the message, Do you want to quit the AcT 5diff AL software? appears, click . The existing user is logged off and the Login screen appears.
4)
Point out the Login screen elements. a) b) The Login Name drop-down menu and the Password field for logging in. The Disable Autoloader check box that allows you to disable the Autoloader mode in case of a malfunction and operate in the Manual mode only. The three icons. On this screen, system. exits the Windows NT operating
c) d)
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The ACT 5diff AL software restrictions and the version currently in use. 1-5
3.
Log into the system and click . The Main Menu screen is displayed and the instrument goes through a hardware reset. Note the message at the bottom of the screen. Describe the Workstation screen elements. a. The header at the top of the screen supplies the name of the screen. 1) 2) b. Currently it says AcT 5diff AL because the main software screen is displayed. This screen is commonly referred to as as the Main Menu screen.
5)
The status bar at the bottom of the screen supplies the date, time, software version, and Operators name. 1) 2) If the instrument is engaged in an activity other than processing samples, the status bar displays the name of the activity. For Startup, Shutdown, manual Prime, and Calibration, the status bar also displays a progress indicator.
c.
Two toolbars (groups of icons that launch functions or screens) are present on every screen, the Generic toolbar and the Contextual toolbar. 1) The Generic toolbar is located on the right side of every screen. a) b) c) d) This toolbar contains the most frequently used functions and the main cycle launch functions. Have the trainee pass the mouse pointer over each icon on the Generic toolbar and read its name. Briefly describe the function of that icon. Reassure the trainee that they will learn the icons functions as they use them and they do not have to memorize them.
Icon Function Stops the Analyzer at a time you specify (immediately, after a cycle is completed, or after cassette analysis is completed). Flashes when a problem is detected and opens the Alarm screen when you click the flashing icon. Launches the Worklist screen and closes all others. The number of samples to be processed is shown below the icon. Starts analyzing the samples in the loaded cassette. Flashes after you run a manual (stat) sample while the Autoloader mode is in progress. Allows you to run a manual (stat) sample. Displays the Results screen; flashes when results have been placed on the Match screen. The number of results in the list is shown under the Results icon. Displays the Archive screen.
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2)
The Contextual toolbar is located across the bottom of every screen. a) b) c) d) This toolbar allows you to manage the screen information, display the help information, and exit the screen. Have the trainee pass the mouse pointer over each icon on the Contextual toolbar and read its name. Briefly describe the function of that icon. Reassure the trainee that they will learn the icons functions as they use them and they do not have to memorize them.
Icon Function Opens the Online Help.
Prints data to a Printer or transmits data to the Host computer.
Displays details.
Allows you to add information.
Deletes data.
Allows editing.
Saves information or validates an action.
Cancels unsaved changes or actions.
Exits from the Main Menu screen to the Login screen. Note: On all other screens, this location is occupied by a return icon. You will see it on the next screen discussed in this topic.
3) d.
If an icon on the Generic toolbar or the Contextual toolbar is grayed out, it means that that function is unavailable on that particular screen.
The central part of the screen is where the software menu or information screens are displayed. 1) The Main Menu screen is the hub of the software. Most of the other software screens are accessed through the options on this screen. a) b) 2) Have the trainee pass the mouse pointer over each icon on the Generic toolbar and read its name. Briefly describe the function of that icon.
If an icon on the Main Menu screen is greyed out, it means that that function is not available to the user group currently logged in.
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Icon
Function Initiates the Startup cycle. The Startup procedure is covered under Heading 2.1, STARTUP PROCEDURE, in this Training Guide. Opens the Run-in-Progress screen which allows you to view the results for the last sample analyzed. Opens the Setup screen which allows you to define system settings. The Setup options are covered in Chapter 3 of this Training Guide. Opens the Reagents screen which allows you to view the existing reagent levels and to change reagents. Reagents are covered under Heading 1.6, REAGENTS AND INSTRUMENT WASTE, in this Training Guide. Opens the Logs screen which allows you to view log entries made by the system. Each Log screen is covered with its relevant topic in this Training guide. For example, the Reagent Log is covered under Heading 1.6, REAGENTS AND INSTRUMENT WASTE. Opens the Diagnostics screen which allows you to perform diagnostic functions. Diagnostic options are covered in Chapter 8 of this Training Guide. Opens the Quality Assurance screen which allows you to run various QA functions. The Quality Assurance options are covered in Chapter 4 of this Training Guide. Initiates the Shutdown cycle. The Shutdown procedure is covered under Heading 2.4, SHUTDOWN PROCEDURE, in this Training Guide.
3)
Have the trainee click to access the Quality Assurance menu. a) Note the pale gray icon in the upper left corner of the screen. This shows the icon selected to display this screen. b) The return icon, , returns you to the previous screen.
4)
While still on the Quality Assurance screen, have the trainee click to access the Online Help system, and explain/show the various ways of accessing information in the Online Help. a) Note that the Help information is for the screen currently displayed. b) c) d) The Online Help System is an electronic book with pages marked to open at the appropriate place for each screen. A navigation bar under the book text allows you to move forward and backward through the text. Tabs on the left side of the screen allow access to several navigation tools: an expandable table of contents, an index, a search feature that highlights its hits, and a place to list favorites topics. on the Navigation bar allows you to access the Help-on-Help topic which fully describes how to use the Online Help System.
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GETTING TO KNOW YOUR INSTRUMENT PRINTER
e.
Give the trainee a copy of the SOFTWARE ICONS AND MENUS PATHS QUICK REFERENCE page from this Training Guide. 1) 2) 3) The front side of this page shows the most common icons used, including those just covered on the Generic and Contextual toolbars and on the Main Menu. The back side of this page has a software menu tree with the options on the Main Menu screen listed on the top. Encourage the trainee to use the software menu tree to explore the software options, accessing Online Help as desired.
f.
Have the trainee find Heading 5.13 WORKING WITH THE SOFTWARE, in the Online Help. This short topic both reviews some of the information just covered and introduces software components that will be used in routine instrument setup and operation.
4.
Give the trainee a copy of the ONLINE HELP SYSTEM from this Training Guide and review the procedures.
1.3
PRINTER
A Objectives
When you have completed this topic, you will be able to: B Locate the Power ON/OFF switch on the Printer. B Locate and explain the use of the ONLINE/OFFLINE button on the Printer. B Change the ink cartridge. B Load paper in the Printer and verify the Printer is ready to print.
B References
Refer to the Printer Users manual to install an ink cartridge and to load paper.
1. 2. If possible, do this topic at a time when an ink cartridge needs to be installed. Remove the paper from the Printer.

Printer 1. The Printer is one of four main components in the ACT 5diff AL system. Point out the Analyzer, Workstation, Printer, and the optional Bar-Code Scanner if you have not already done so. 2. The function of the Printer is to print either a copy of the screen displayed on the monitor or of data stored in the computers database. a. Use the Printer supplied or approved by Beckman Coulter as their drivers have been checked for compatibility with the Workstation software. 1) If you want to add a Windows NT-compatible Printer to your system, contact a Beckman Coulter Representative before doing so to verify the latest
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1-9
GETTING TO KNOW YOUR INSTRUMENT BAR-CODE SCANNER (OPTIONAL)
configurations available and, if needed, to obtain help installing an approved Printer driver not resident in the software. 2) b. 3. The procedure for selecting the default Printer is covered under Heading 3.4, SYSTEM SETUP OPTIONS in this Training Guide.
Check the Printer routinely as part of the Start-Up procedure to ensure it has sufficient paper and is ready to print. Power ON/OFF switch. This switch internally connects and disconnects the power source to the Printer. ONLINE/OFFLINE button. This switch internally connects (on-line) and disconnects (off-line) the data source to the Printer.
Identify the following Printer components. a. b.
4. 5.
In the Printers Users manual, locate the procedure for installing an ink cartridge and help the trainee do it. In the Printers Users manual, locate the procedure for loading paper, and help the trainee do it.
1.4
BAR-CODE SCANNER (OPTIONAL)

A Objectives
When you have completed this topic, you will be able to: B State the function of the optional Barcode Scanner.
B References
In the Online Help System or the Instructions for Use manual, refer to: r r
Heading 5.6 WORKING WITH BAR-CODE LABELS Appendix B BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND
The system must be powered up only if you want to demonstrate using the Barcode Scanner.

1. The Barcode Scanner is an optional component for the ACT 5diff AL system. Point out the Analyzer, Workstation, Printer, and the optional Bar-Code Scanner if you have not already done so. 2. The function of the Barcode Scanner is to read barcode labels on specimen tubes and control vials and to transmit that information to the Workstation. a. The types of bar-code labels the Analyzer can accept is covered under Appendix B, BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND, in the Online Help System or the Instructions for Use manual. Your Beckman Coulter Representative will ensure your Barcode Scanner is set up correctly to read your laboratorys bar-code labels.
b.
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GETTING TO KNOW YOUR INSTRUMENT ANALYZER
3. 4.
The instructions for using the Barcode Scanner correctly are under Heading 5.6, WORKING WITH BAR-CODE LABELS, in the Online Help System or the Instructions for Use manual. If your laboratory has a Barcode Scanner, using it correctly will be emphasized under Heading 6.2, SAMPLE IDENTIFICATION, in this Training Guide.
1.5
ANALYZER
A Objectives
When you have completed this topic, you will be able to: B Locate and name the hardware controls and indicators on the Analyzer. B Name the two modes for processing specimen tubes. B Locate the Cap-Pierce module. B Explain how to select the correct tube holder and sample position. B Demonstrate how to interchange the tube holders. B Locate the list of collection devices and vials approved for use in the tube holders. B Explain when and how you would run open-vial specimens. B Locate the cassette input tray and the cassette output tray in the Autoloader module. B Describe the cassette labeling. B Load and unload a cassette correctly. B Locate the list of collection devices and vials approved for use in the cassettes. B Briefly describe the path of a specimen tube processed in the AL mode. B Explain why the ACT 5diff AL analyzer is referred to as a single point of aspiration system.
B References
1. In the Online Help System or the Instructions for Use manual, refer to:
r r r r r ACT 5diff AL Analyzer under Heading 1.4 DESCRIPTIONS Heading 5.8 WORKING WITH THE TUBE HOLDER Heading D.3 TUBES FOR USE IN THE TUBE HOLDER (FOR MANUAL MODE) Heading 5.7 WORKING WITH THE CASSETTES Heading D.4 TUBES FOR USE IN THE CASSETTES (FOR AUTOLOADER MODE) Heading 2.4 CASSETTE TRANSFER CYCLE
r 2.
TUBE HOLDERS QUICK REFERENCE page. CASSETTES QUICK REFERENCE page.
1. The instrument must be powered up.
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1-11
2. 3.
Any screen on which the Generic toolbar icons displayed.
and
are active can be
To demonstrate the Manual and Autoloader modes, the trainer will need a few specimen tubes with pierceable caps. Either specimen tubes with blood samples or specimen tubes that are clean and empty can be used.

1. The Analyzer is one of four main components in the ACT 5diff AL system. Point out the Analyzer, Workstation, Printer, and the optional Bar-Code Scanner if you have not already done so. 2. The function of the Analyzer is to: a. b. c. d. e. f. g. 3. a. Transport the specimen tube. Identify and mix the specimen. Pierce the cap of the specimen tube. Aspirate a blood sample from the tube. Aliquot and dilute the blood sample. Analyze the sample. Transmit the results to the Workstation. Power switch on the right side of the Analyzer. 1) 2) This switch turns the Analyzer power on and off. To maintain correct communication between the Analyzer and the Workstation, only use this switch when specified in the System Power Down sequence; DO NOT simply turn off the Analyzer. 3) The correct power down sequence is covered under Heading 5.3 POWERING UP AND LOGGING ON/POWERING DOWN AND LOGGING OFF , in the Online Help System or the Instructions for Use manual. Red and green LEDs (light emitting diodes) 1) 2) 3) 4) c. Used to quickly identify instrument status. If either light is lit, the Analyzer power is ON; if neither light is lit, the Analyzer power is OFF When green LED is lit, the instrument is ready for operation When red LED is lit or flashing, the instrument is busy.
Locate the following components on the Analyzer.
b.
Cap-Pierce module 1) The Analyzer can process samples in either of two modes: the Manual mode and the Autoloader mode. 2) The Cap-Pierce module is used to analyze samples in the Manual mode. a) b) In the Manual mode, specimens are loaded into the tube holder and processed one at a time. The Manual mode is used to analyze STAT specimens and any specimen in a non-pierceable collection device.
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3) 4)
If the tube holder door is closed, click
to open it.
Two tube holders, each with slots of four different sizes, accommodate various sized specimen tubes, micro collection devices, and control vials. a) b) Tube holder #1 has one dot in its center; tube holder #2 has two dots. Sample positions within the tube holder are notched to correlate with the number assigned to that position; for example, sample position 3 has three notches next to its tube slot. Slot numbering sequence is counterclockwise. Indentations on the side of the tube holders are sensed by switches in the Cap-Pierce module to determine which tube holder is inserted and the size of the tube slot located in the piercing position. Software settings for each slot determine how far the sampling probe moves down into the specimen. Refer to Appendix D.3 TUBES FOR USE IN THE TUBE HOLDER (FOR MANUAL MODE), for the list of whole-blood collection devices and control vials compatible with the Cap-Pierce module. Beckman Coulter does not guarantee the performance of any tube in the Cap-Pierce module other than those listed.
c) d)
e) 5)
Each type tube/vial has an assigned slot in a tube holder. a)
b) c)
6)
The list is not a recommendation for using one tube in preference to another nor does it guarantee the acceptability of the specimen tube to produce quality results. The tube holders are interchangeable. a) b) c) To remove a tube holder, lower the tube holder door and pull the holder off the metal shaft. To install a tube holder, slide the desired holder over the metal shaft then rotate the tube holder until the correct slot is at the piercing position. Leave a tube holder installed.
7)
The correct piercing position is with the tube slot at 12 oclock. The tube holder can be rotated manually in either direction to bring the tube slot to the correct position. b) The specimen collection device must be in the slot at the 12 oclock piercing position for a sample to be aspirated. c) Either an open vial or a closed vial with a pierceable cap can be placed in the piercing position. For evacuated collection tubes, micro-collection devices, and calibrator vials without pierceable stoppers or caps: a) The stopper/cap must be removed prior to open-vial sampling. b) Open-vial sampling increases the Operators exposure to the whole-blood specimen which is considered a biohazardous material. The tube-holder door has three positions: open, closed, and sampling. An open door allows you to load a specimen in the tube holder. A closed door is normal for all operations except using the Manual mode. 1-13 a)
8)
9)
a) b)
PN 177196BB
c)
Pushing the door in past the closed position to the sampling position aligns the specimen for aspiration and initiates the cycle.
Note: The door can only be pushed into the sampling position when has been selected and a sample ID entered. 10) When the Manual mode is initiated, the piercing needle and sampling probe are lowered to the assigned depth in the specimen tube. a) b) If the tube has a pierceable cap, the piercing needle pierces the cap. When the sampling probe tip is at the correct depth, a blood sample is aspirated for processing.
11) For demonstration purposes, use a blood specimen from the laboratory or a clean empty specimen tube. a) b) c) d) e) a) b) c) At the Workstation, click . The tube holder door opens.
Ensure the correct tube holder for the specimen tube is installed. Ensure the correct tube holder slot is in the piercing position. Enter a sample ID and click .
When the prompt When tube holder opens, insert sample ID XXX for analysis appears, load the tube, bottom first, into the tube holder. Push the tube holder door into the sampling position. The red and green LEDs alternately flash approximately six seconds then the red LED glows steadily for the remainder of the cycle. The door opens automatically and the green LED lights when aspiration is completed.
d.
12) This information about the Manual mode is covered under Heading 5.8 WORKING WITH THE TUBE HOLDER, in the Online Help System or the Instructions for Use manual. 13) Give the trainee a copy of the TUBE HOLDERS QUICK REFERENCE page and remind them that detailed information is available in the Hematology Tube List. Refer to the Hematology Tube List available on the BCI website at www.beckmancoulter.com. Autoloader module 1) 2) The Analyzer can process samples in either of two modes: the Manual mode and the Autoloader mode. The Autoloader module is used to analyze samples in the Autoloader mode. a) In the Autoloader mode specimen tubes are loaded into cassettes, up to 10 tubes per cassette, and the cassettes are loaded into the Autoloader module, up to 10 cassettes at a time. The Autoloader module can only process closed-vial specimen tubes, so a specimen tube or vial must have a pierceable cap.
b)
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PN 177196BB
3)
All 10 cassette styles are physically identical but it is possible to instruct the instrument to sample differently from cassette to cassette to accommodate different tubes. a) b) c) d) e) The bar-code label on the front of the cassette identifies the number of the cassette (1 through 10) and the style (A or B). The number of each cassette is labeled on the back of the cassette. The letter of each cassette is labeled on the front of the cassette. The letter identifies the cassette style, which defines the tube type/size that can be used in it.
4)
Software settings for each cassette style determine the sampling conditions for each (the assigned depth the piercing needle and sampling probe are lowered into the specimen tubes). f) For the list of whole-blood collection devices compatible with the Autoloader module, refer to the Hematology Tube List available on the BCI website at www.beckmancoulter.com. The ten tube positions within a cassette are numbered on top of the cassette. a) b) c) This number is referred to as the position number. When you see Cass./Position, the number assigned to the cassette is listed first, followed by the number assigned to the position within the cassette. When you load the cassette into the instrument, the tube in position 1 is the first one processed.
5)
While the Analyzer is idle, lower the left and right front doors and point out the main components along a cassettes path through the Autoloader. You can elect to identify more. a) b) c) The filled cassette is placed on the CASSETTE INPUT TRAY. The Autoloader module moves the cassette to the front of the cassette input tray and then along a track at the front of the Analyzer. When the cassette reaches the MIXER ARM, the grabbers on the mixer arm removes up to two specimen tubes from the cassette and rotates the tubes to mix them. The mixer arm returns the tubes to the cassette and the cassette is moved to the BAR-CODE READER which reads the bar-code label on the cassette, and the specimen tube if one is present, to identify the specimen. The cassette is then moved back to the mixer arm. During the processing, each specimen tube is mixed twice. The cassette is then moved into the piercing position where the tube is aligned with the bar-code reader and the piercing needle/sampling probe. Before the tube is pierced, the bar-code reader rereads the bar-code labels. Next the PIERCING NEEDLE AND SAMPLING PROBE are lowered to the assigned depth in the specimen tube and a sample is aspirated. Note: You cannot see the piercing needle and sampling probe as they are normally raised.
d)
e) f) g) h)
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1-15
i)
After all the specimens in the cassette are analyzed, the Autoloader module moves the cassette to the right end of the track and then pushes the cassette onto the CASSETTE OUTPUT TRAY. The Operator removes the cassette and unloads the specimen tubes.
j)
6)
For demonstration purposes, run a cassette with several specimen tubes. a) b) Obtain blood specimens from the laboratory or use clean empty tubes. Load a cassette by inserting the tubes, bottom first, into the cassette, then pushing the tube top into the holder until the tube snaps into place.
7)
Close the left and right front doors. These doors have interlocks that inhibit operation while they are open. Note: Service trainers have the option of logging in as themselves and leaving these doors open during the demonstration. If you do this however, be sure the trainee is aware of both the mechanical and biological hazards.
8)
Initiate the Autoloader cycle: a) Place the loaded cassette in the cassette input tray, noting that the back of the cassette faces the front of the Analyzer. At the Workstation, click . The cassette loading pushers move the cassette to the front of the track and the cassette is pulled onto the track. The red LED starts flashing and continues to do so until the cassette is completed and unloaded onto the cassette output tray.
b) c) 9)
This information about the Autoloader mode is covered under Heading 2.4 CASSETTE TRANSFER CYCLE, and Heading 5.7 WORKING WITH THE CASSETTES, in the
4.
Online Help System or the Instructions for Use manual. 10) Give the trainee a copy of the CASSETTES QUICK REFERENCE page and remind them that detailed information is available in the Hematology Tube List. Refer to the Hematology Tube List available on the BCI website at www.beckmancoulter.com. This instrument is referred to as a single point of aspiration system because all samples whether analyzed in the Manual mode (open-vial or closed-vial) or in the Autoloader mode, are aspirated into the system at the same location with the same hardware. The Analyzer can analyze a blood sample for 10 CBC parameters, 10 diff parameters, and an additional six RUO (research use only) parameters. a. Two test panels are available: CBC and CBC/DIFF . 1) 2) 3) b. CBC consists of WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, and MPV. CBC/DIFF consists of WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, and BA#. For the complete list, refer to Heading 1.4 PARAMETERS, in the Online Help System or the Instructions for Use manual. The default test panel is used unless the Operator selects otherwise.
5.
The Operator can set either test panel, CBC or CBC/DIFF , as default. 1)
1-16
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GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE
2) 3) c. 1)
The default test panel is always used if the laboratory runs without a Worklist. If the laboratory uses a Worklist, a test panel can be selected for each specimen. These options are covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide. To view the current settings, from the Main Menu screen click General tab. tt tt
Selecting the default test panel and the RUO parameters are setup options.
2)
1.6
REAGENTS AND INSTRUMENT WASTE

A Objectives
When you have completed this topic, you will be able to: B Locate the reagent compartment. B Name the reagents used on the ACT 5diff AL hematology analyzer. B State if the reagent is used for CBC analysis, DIFF analysis, or both. B State the open container stability of each reagent used on an ACT 5diff instrument. B Explain/demonstrate how to change reagents. B Access the Reagent Log and explain how to add comments. B Prime reagents manually. B Explain/demonstrate how to handle and replace a waste container, if applicable.
B References
r Heading 1.8, REAGENTS. Replacing Reagents under Heading 11.11, REPLACEMENT PROCEDURES. Handling Expired Reagents under Heading 11.4 WASTE HANDLING PROCEDURES. Replacing the Waste Container under Heading 11.11, REPLACEMENT PROCEDURES. Neutralizing the Waste and Treating for Biohazards under Heading 11.4 WASTE HANDLING PROCEDURES.
r r
r
r 2.
REAGENT REPLACEMENT SUMMARY. WASTE CONTAINER REPLACEMENT.
1. 2. 3. The instrument must be powered up for entering reagent information and priming. If possible, do this topic when a reagent container needs to be installed. If possible, do this topic when a waste container (if used) needs to be installed/replaced.
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1-17

Reagents 1. ACT 5diff AL hematology analyzer uses four reagents to dilute and prepare the blood samples for analysis and one to clean the Analyzer. a. Four of these reagents are housed in the reagent compartment. b. Open the reagent compartment door, identify each of the reagents, and review the information for that reagent listed below. Note: Service trainers may want to identify and review the function of each reagent as they install it. The fifth reagent is a 20 L container of Diluent. 1) 2) d. The Diluent generally sits on the floor below the instrument. Locate the Diluent container and review its function as listed below.
c.
To obtain the optimum performance characteristics stated in the Instructions for Use manual, use the following reagents on your ACT 5diff AL hematology analyzer.
Label Color Purple Function r Isotonic solution that dilutes the sample r Stabilizes cell membranes r Conducts aperture current r Provides the sheath medium for focused flow through the flow cell r Rinses Analyzer components after analysis r Contains less than 0.1% sodium azide which may cause an explosion if not properly flushed down the drain with large volumes of water r Disrupts erythrocytes (lysis) r Frees hemoglobin r Reduces cellular debris r Converts hemoglobin to a stable cyanidecontaining pigment r Contains potassium cyanide, a quarternary ammonium salt; special instructions are provided for proper disposal r Dilutes the sample for the total WBC count r Specifically differentiates between the basophils and other white blood cells for the basophil percentage analysis r Lyses red blood cells r Reduces cellular debris CBC c Open Container DIFF Stability c Same as shelf life (date printed on the container)*
Reagent ACT 5diff Diluent
ACT 5diff Hgb Lyse
Orange
90 Days
ACT 5diff WBC Lyse Yellow
Same as shelf life (date printed on the container)*
1-18
PN 177196BB
Reagent ACT 5diff Fix
Label Color Green
Function r Lyses red blood cells r Preserves the white blood cells in their native state r Stains the granules of eosinophils, neutrophils, and monocytes r Provides the dilution used to differentiate the white blood cell subpopulations using the absorbance cytochemistry technology r Cleans and rinses the diluter parts r Prevents protein buildup
CBC
Open Container DIFF Stability c Same as shelf life (date printed on the container)*
ACT 5diff Rinse
Blue
r Eliminates routine aperture bleaching * This open container stability claim applies only if the reagent is properly connected to the Analyzer with an approved reagent pickup and cap.
Same as shelf life (date printed on the container)*
2.
Always handle the reagents as instructed in the Instructions for Use manual. a. When a reagent arrives, inspect the containers for any indication the reagent has been frozen. Discard any reagent that you know or suspect has been frozen. Note: If a reagent is frozen during transport or storage, active components may separate (layer) which can cause inconsistency of components and affect parameter results. Gently mix the reagent containers by inversion before storing them. Note: Allow sufficent time for microbubbles to dissapate before using the reagents as microbubbles can increase background counts and affect parameter results. c. Store all reagents at an ambient temperature of 18C to 25C. Do not pool reagents; pouring reagents from one container to another may contaminate the new reagent container which will cause unacceptable background results, especially for PLT. Make sure the lot number on the new container is the next one in ascending chronological and container order. Make sure the label on the stopper assembly tubing correlates with the reagent name on the new container. When transferring the stopper assembly from the old container to the new, do not touch the pickup tubes or lay the assembly on an uncovered tabletop or the floor. 1) 2) 3) If the pickup tube portion of a stopper assembly is contaminated during transfer, bacterial and/or fungal growth may occur inside the reagent container. Contamination may cause unacceptable background results especially for PLT.
b.
3.
When changing a reagent: a.
b. c. d.
e. 4.
PN 177196BB
If a pickup tube touches you or anything outside the container, flood the pickup tube with distilled water then wipe it with a lint-free tissue before inserting it in the new reagent container. Always dispose of reagents and containers according to your laboratorys protocol. and review the Reagent Status screen. 1-19
From the Main Menu screen, click
Note: Service trainers may want to demonstrate updating Reagent information as they install the reagents. a. The Reagent Status screen shows the percent of each reagent left, based on the number of cycles done since the reagent counter was reset. 1) 2) Double-clicking a reagent level displays the Reagent screen for that reagent. If you enter or change information on this screen, the system automatically updates the reagent information, primes the reagent, and updates the level indicator.
b.
The Reagent Status screen also indicates if sufficient reagent is available for the estimated Daily Workload. 1) The Daily Workload estimation is one of the setup options covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current entries, from the Main Menu screen click
Cycle Options tab.
2) c. 5.
tt
tt
Based on the percent reagent left and what is needed for the Daily Workload, determine which, if any reagent, needs to be changed.
Help the trainee find Replacing Reagents under Heading 11.11, REPLACEMENT PROCEDURES, in the Online Help System or the Instructions for Use manual.
a. b. 6. 7.
Have the trainee use the appropriate procedure in this section to replace any reagent that needs to be replaced. Walk the trainee through any reagent replacement procedure not used.
Give the trainee a copy of the REAGENT REPLACEMENT SUMMARY from this Training Guide and review the procedures. When you change a reagent, the event is automatically entered in the Reagent Log. a. From the Main Menu screen, click 1) 2) 3) 4) b. c. tt to access the Reagent log.
The most recent reagent changed is displayed on the top of the log screen. The log entry includes the date and time of the event, the name of the Operator logged in, and the name of the reagent changed and its expiration date. The Reagent log saves entries for up to five years. Prior entries to the log are deleted on a first in, first out basis as the capacity is exceeded.
To add comments to an entry (up to 50 alphanumeric characters), click on the entry and then on the Add Comments button. You can also elect to have the system display a comments field automatically whenever you change reagents. 1) The Logs (comments) options are part of the setup options covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide.
1-20
PN 177196BB
2) 8. a.
To view the selection, from the Main Menu click
tt
tt General tab.
Reagents can be primed manually. Manual priming needs to be done if automatic priming does not completely fill the lines with reagent (such as during the initial installation of the instrument) or if an instrument problem introduces air into the reagent lines. To prime a reagent manually: 1) 2) From the Main Menu screen, click tt tt tt Prime Reagents tab.
b.
Click the desired reagent prime option. The name and progress of the Prime cycle is displayed in the Status bar. When the Analyzer has completed the prime function, click return to the Main Menu screen. as needed to
3) c.
Information about manually priming reagents is covered in Diluter Systems, Prime Reagents, under Heading 11.6, DIAGNOSTICS USER SCREEN, in the Online Help System or the Instructions for Use manual. Note: The reagent prime function does not reset the reagent volume. Only the change reagent function updates (resets) the level indicator.
Waste 1. Point out the waste output line and the waste sensor line on the back of the Analyzer. The waste can be connected directly to a drain line or collected in a container.
WARNING Risk of explosion. The Diluent contains sodium azide as a preservative. Sodium azide can form explosive compounds in a metal drain if it is not properly flushed down the drain with large volumes of water. When disposing of waste down the drain, ensure the drain line is flushed with large volumes of water. (See the National Institute for Occupational Safety and Health Bulletin: Explosive Azide Hazards [8/16/76].)
2.
If the waste is hooked up to a drain line: a. b. c. Care must be taken to secure the line to avoid leakage of biohazardous material. A waste sensor line is not connected; the connector is bypassed. The drain line must have a full water flow as the Diluent contains sodium azide. The container is usually placed near the Diluent container. A pickup tube with a level sensor is used to monitor the level of waste. The waste sensor is connected to the back of the Analyzer. At the beginning of each day, the waste container level is checked to determine if it needs to be replaced. The contents are biohazardous and must be disinfected before disposal.
3.
If the waste is hooked up to a container: a. b. c. d. e.
4.
If the laboratory plans to use a waste container, help the trainee find Replacing the Waste Container under Heading 11.11, REPLACEMENT PROCEDURES, in the Online Help System or the Instructions for Use manual.
PN 177196BB
1-21
a. b.
If the waste container is ready for replacement, have the trainee use this procedure to replace the container. Make sure the trainee continues the procedure to the end, which includes doing the Neutralizing the Waste and Treating for Biohazards procedure under Heading 11.4, WASTE
HANDLING PROCEDURES.
c. 5.
Walk the trainee through the waste procedure if the waste does not need to be changed.
If the laboratory plans to use a waste container, give the trainee a copy of the WASTE CONTAINER REPLACEMENT page from this Training Guide and review the procedure.
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PN 177196BB
2STARTUP / SHUTDOWN 2
2.1 STARTUP PROCEDURE
A Objectives
When you have completed this topic you will be able to: B Explain the difference between a Startup procedure and a Startup cycle. B Start up the instrument following the recommended Startup procedure. B Recognize out-of-limit Startup results. B Access the Startup Log. B Add a comment to the Startup Log. B Explain how to handle an unacceptable background result.
B References
1. In the Online Help System or the Instructions for Use manual, refer to
r r r Heading 6.1 WASTE CONTAINER LEVEL CHECK Heading 6.2 PRINTER CHECK Heading 6.3 STARTUP
2.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the STARTUP SUMMARY.
1. 2. The instrument must be powered up. Have the Main Menu screen displayed.

1. The Startup procedure prepares the instrument for analyzing patient samples. a. b. 2. The Startup procedure includes the Startup cycle, but also includes checking the waste level, ensuring the Printer is ready to print, and running controls. The Startup cycle is one of four automated cycles that draw and dispense reagent to prime, rinse, or clean the system: Startup, Mini-Clean, Auto-Clean, and Shutdown. Primes the Diluent, Hgb Lyse, WBC Lyse, and Fix reagents lines and pumps. Replaces the Rinse reagent left in the Analyzer after the Shutdown routine with Diluent reagent. Includes a software routine that: 1) 2) Displays a progress indicator in the Status bar at the bottom of the screen to show how close the Startup cycle is to completion. Does a background count at the end of the Startup cycles. a) b) A background count is an analysis of the reagents without a blood sample. If the Startup cycle fails, the system automatically does up to two more cycles.
The Startup cycle is a sequence of Analyzer cycles that: a. b. c.
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2-1
STARTUP / SHUTDOWN STARTUP PROCEDURE
c) 3)
The Startup results are reported as Passed (which indicates that all checks passed the limits) or Failed.
When run at the beginning of a New Workday, checks for sufficient reagent volume to complete the Daily Workload. a) b) The reagent volumes needed for the Daily workload is based on the typical CBC/DIFF and CBC workload entered into the software as part of setup. The procedure for entering the estimated Daily Workload is covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current entries, from the Main Menu screen click tt Cycle Options tab. tt
c)
3.
A Startup cycle can be initiated in two ways: automatically and on demand (manually). a. If automatic startup is selected (enabled), when the system is powered up from a powered down state it automatically does a Startup cycle. 1) 2) 3) Enabled (ON) is the recommended setting. Disabled (OFF) is the default setting. The procedure for enabling or disabling the automatic startup option is covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current setting, from the Main Menu screen click
Cycle Options tab.
4)
tt
tt
b.
On the Main Menu screen, click 1) 2) 3)
to manually initiate a Startup cycle.
Watch the progress indicator to determine the progress of the cycle. If the Startup cycle fails, the system automatically does up to two more cycles. If Autoprint is enabled, a Background report automatically prints when the routine is finished. a) b) c) The printout includes the parameter results and the Startup status, Passed or Failed, printed on the top right side of the Background Report. Printing the Startup results automatically is a system setup option. This option is covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current setting, from the Main Menu screen click tt Printer. tt
d)
4.
The Startup results can be viewed on the Run-in-Progress screen and in the Startup Log. a. On the Main Menu screen, click 1) to display the Run-in-Progress screen.
The parameter results for the background count (the last sample analyzed) are displayed.
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2-2
STARTUP / SHUTDOWN STARTUP PROCEDURE
2) 3)
The Startup status is not displayed. If during the cycle the system detected the reagent is expired, Reagent expired appears in the Miscellaneous Messages in the tree view and flashes.
b.
On the Main Menu screen, click 1) 2) 3) 4) 5) 6)
tt
to display the Startup Log screen.
The Startup Log displays the most recent results on the top of the log screen. The log entry includes the date and time of the event, the name of the Operator logged in, and the background count results and Startup status. The entry line is green if Startup passed, red if Startup failed or if the background counts are out of limits. To add comments to an entry, you click on the entry and then on the Add Comments button. The Startup Log saves entries for one year. Prior entries to the log are deleted on a first in, first out basis as the capacity is exceeded.
5.
Messages are generated if a Startup cycle fails. a. Failed printed on the Background Report indicates that one or more of the checks failed the limits. 1) Background limits are fixed and cannot be changed. Acceptable limits are: WBC 0.3 x 103 cells/L RBC 0.03 x 106 cells/L Hgb 0.3 g/dL Plt 7.0 x 103 cells/L Flowcell WBC 0.3 x 103 cells/L If all parameter values are within limits, the Hgb Blank and Read check failed.
2) b. c. 6.
Startup Failed printed on a patient sample printout means the patient sample was analyzed after Startup failed. Startup Not Effective printed on a patient sample printout means the Startup was not completed while at the Service access level. If one or more parameter results failed: 1) 2) On the Main Menu screen, click to repeat the Startup cycle.
If a Startup cycle fails, check the background count results. a.
If Startup continues to fail, contact your Beckman Coulter Representative.
b.
If all the parameter results passed but the Startup status failed: 1) 2) On the Main Menu screen, click Errors Log screen. tt to display the Alarms and
Check the latest entry in the Alarms and Errors Log and verify the date and time correlate with this incident.
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STARTUP / SHUTDOWN MINI-CLEAN CYCLE
3) 4) 5) 7. a. b. 8.
Locate Heading 11.4 SYSTEM ERRORS, in the Online Help System or the Instructions for Use manual and look up the message in the Error table. Complete the suggested action. For more assistance, contact your Beckman Coulter Representative.
Always do a Startup cycle: Anytime Rinse reagent has replaced Diluent in the aperture baths (such as after a Shutdown cycle). Whenever four or more hour have elapsed since the Analyzer was last cycled.
After doing a Startup cycle, it is recommended that quality control checks be done before running patient specimens according to your laboratory protocol.
9.
Help the trainee find and do the three procedures in the Online Help System or the Instructions for Use manual that make up the Startup procedure: Heading 6.1, WASTE CONTAINER LEVEL CHECK, Heading 6.2 PRINTER CHECK, and Heading 6.3 STARTUP.
10. Give the trainee a copy of the STARTUP SUMMARY from this Training Guide and review the procedure.
2.2
MINI-CLEAN CYCLE
A Objectives
When you have completed this topic, you will be able to: B Initiate a Mini-Clean cycle. B State the difference between a Startup cycle and a Mini-Clean cycle. B Identify when to do a Startup cycle versus when to do a Mini-Clean cycle.
B References
In the Online Help System or the Instructions for Use manual, refer to Mini-Clean (Running) under Heading 11.5 DIAGNOSTICS MENU SCREEN.

1. 2. The Mini-Clean cycle is one of four automated cycles that draw and dispense reagent to prime, rinse, or clean the system: Startup, Mini-Clean, Auto-Clean, and Shutdown. The Mini-Clean cycle: a. b. Primes the Diluent, Hgb Lyse, WBC Lyse, and Fix reagents lines. Does not do a background count
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STARTUP / SHUTDOWN AUTO-CLEAN CYCLE
3. 4. 5.
From the Main Menu screen, click
tt
to initiate the Mini-Clean cycle.
The Mini-Clean (Running) procedure is located under Heading 11.5 DIAGNOSTICS MENU SCREEN, in the Online Help System or the Instructions for Use manual. Whether you need to do a Startup cycle or a Mini-Clean cycle is determined by the state of the instrument at the time you are ready to process patient samples or controls. a. b. A Startup cycle must be done before running patient samples or controls after a Shutdown cycle. A Mini-Clean cycle must be done before running patient samples or controls: 1) 2) Anytime the Analyzer has set idle (uncycled) more than two hours. Anytime the Analyzer is powered down, then powered back up again. Note: If your laboratory has selected the automatic Startup option, a Startup cycle is automatically done when you power up and a Mini-Clean cycle is not needed. c. The software is programmed to initiate a Mini-Clean before analyzing a patient sample if two or more hours has elapsed since the last sample was analyzed.
2.3
AUTO-CLEAN CYCLE
A Objectives
When you have completed this topic, you will be able to: B Explain the purpose of the Auto-Clean cycle. B Initiate an Auto-Clean cycle
B References
In the Online Help System or the Instructions for Use manual, refer to Auto-Clean (Running) under Heading 11.5 DIAGNOSTICS MENU SCREEN.

1. 2. 3. The Auto-Clean cycle is one of four automated cycles that draw and dispense reagent to prime, rinse, or clean the system: Startup, Mini-Clean, Auto-Clean, and Shutdown. The Auto-Clean cycle delivers Rinse reagent to the baths assembly to clean the baths and apertures, and then flushes the baths with Diluent. An Auto-Clean cycle can be initiated in two ways: automatically and on demand (manually). a. The software is programmed to automatically run an Auto-Clean cycle after a certain number of samples have been processed. 1) The default setting is 100 samples.
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STARTUP / SHUTDOWN SHUTDOWN PROCEDURE
2)
The procedure for setting the frequency of the automatic Auto-Clean cycle is covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current setting, from the Main Menu screen click
Cycle Options tab.
3)
tt
tt
b.
From the Main Menu screen, click Auto-Clean cycle. 1) 2)
tt
to manually initiate the
During the Auto-Clean cycle the progress indicator provides a visual display of how close the routine is to completion. The Auto-Clean (Running) procedure is located under Heading 11.5 DIAGNOSTICS MENU SCREEN, in the Online Help System or the Instructions for Use manual.
2.4
SHUTDOWN PROCEDURE
A Objectives
When you have completed this topic, you will be able to: B Initiate a Shutdown cycle. B State how often a Shutdown cycle must be done. B State the minimum time the Rinse reagent should remain in the instrument during Shutdown.
B References
1. 2. In the Online Help System or the Instructions for Use manual, refer to Heading 6.4
SHUTDOWN.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the SHUTDOWN SUMMARY.
1. 2. The instrument must be powered up. Have the Main Menu displayed.

1. 2. The Shutdown cycle is one of four automated cycles that draw and dispense reagent to prime, rinse, or clean the system: Startup, Mini-Clean, Auto-Clean, and Shutdown. The Shutdown cycle is a sequence of Analyzer cycles that: a. b. 3. Pull and dispense Rinse reagent into the Analyzer, displacing the Diluent, to clean the Analyzer and minimize protein buildup. Includes a software routine that logs you out of the ACT 5diff software and gives you the option of exiting or restarting Windows.
A Shutdown cycle can be initiated in two ways: automatic and on demand (manually).
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STARTUP / SHUTDOWN SYSTEM POWER DOWN PROCEDURE
a.
If automatic shutdown is selected (enabled), the system is shutdown at the time designated in the software. 1) 2) Enabled (ON) is the recommended and the default setting. The procedure for enabling or disabling the automatic shutdown option is covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current setting, from the Main Menu screen click
Cycle Options tab.
3)
tt
tt
b.
On the Main Menu screen, click 1) 2) 3)
to manually initiate a Shutdown cycle.
Watch the progess indicator to determine the progress of the cycle. At the end of the cycle select Restart Windows. Log in when the Login screen appears.
4. 5.
Help the trainee find and do the Manual Shutdown Procedure under Heading 6.4 SHUTDOWN, in the Online Help System or the Instructions for Use manual. Point out that Beckman Coulter recommends that the laboratory: a. b. Do a Shutdown once every 24 hours that the instrument is in use. Allow the Rinse reagent to remain in the instrument a minimum of 30 minutes to minimize protein buildup in the instrument.
6. 7.
Give the trainee a copy of the SHUTDOWN SUMMARY from this Training Guide and review the procedure. A Startup cycle must be completed prior to running patient specimens or controls.
2.5
SYSTEM POWER DOWN PROCEDURE

A Objectives
When you have completed this topic, you will be able to: B Power down the ACT 5diff AL system correctly.
B References
1. In the Online Help System or the Instructions for Use manual, refer to Powering Down the System and Logging Off under Heading 5.3 POWERING UP AND LOGGING ON/POWERING DOWN AND LOGGING OFF . In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the SYSTEM POWER DOWN SUMMARY.
2.
1. 2.
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The instrument must be powered up. Have the Main Menu screen displayed. 2-7
STARTUP / SHUTDOWN SYSTEM POWER UP PROCEDURE

1. 2. 3. 4. The System Power Down procedure turns off the Workstation and the Analyzer in a specific sequence to avoid damage to the instrument. You must power down the system when opening certain doors and panels on the instrument to prevent personal injury from electric shock. Some laboratories choose to power down their system as part of Shutdown. If New Workday conditions are met while the Login screen is displayed, you must power down the system to update the Login screen with the New Workday options. New Workday options are discussed under Heading 5.4, NEW WORKDAY, in the Online Help System or the Instructions for Use manual. 5. It is recommended that you power down the system at least monthly to trigger the Windows NT automated system maintenance procedure. Refer to Heading 11.8, SHUTTING DOWN WINDOWS-NT (RECOMMENDED), in the Online Help System or the Instructions for Use manual. 6. Help the trainee find and print copies of the Powering Down the System and Logging Off procedure and the Powering Up the System and Logging On procedure under Heading 5.3 POWERING UP AND LOGGING ON/POWERING DOWN AND LOGGING OFF in the Online Help System or the Instructions for Use manual. Note: If the trainee is using a laptop computer to view the Instructions for Use manual and the laptop can be located near the instrument for easy reference, it is not necessary to print these procedures. 7. 8. Have the trainee power down the instrument completely using the Powering Down the System and Logging Off procedure. Give the trainee a copy of the SYSTEM POWER DOWN SUMMARY from this Training Guide and review the procedure. If the laboratory plans to power down as part of Shutdown, point out that they can use this summary instead of the SHUTDOWN SUMMARY.
2.6
SYSTEM POWER UP PROCEDURE

A Objectives
When you have completed this topic, you will be able to: B Power up a system that has been shutdown and then powered down. B Power up a system that has been powered down without being shutdown.
B References
1. In the Online Help System or the Instructions for Use manual, refer to Powering Up the System and Logging On under Heading 5.3 POWERING UP AND LOGGING ON/POWERING DOWN
AND LOGGING OFF.
2.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the SYSTEM POWER UP SUMMARY.
1. 2-8 The instrument must be powered down.
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2.
Since the instrument is powered down, the trainee will need either a printed copy of the Powering Up the System and Logging On procedure or a computer near the instrument displaying that procedure. The procedure is located under Heading 5.3 POWERING UP AND LOGGING ON/POWERING DOWN AND LOGGING OFF, in the Instructions for Use manual.

1. The System Power Up procedure turns on the Workstation and the Analyzer in a specific sequence to avoid damage to the instrument and maintain good communications between the Workstation and the Analyzer. Have the trainee power up the instrument using the Powering Up the System and Logging On procedure. Give the trainee a copy of the SYSTEM POWER UP SUMMARY from this Training Guide and review the procedure. If the laboratory plans to power down as part of Shutdown, point out that they can use this summary for Startup instead of the STARTUP SUMMARY.
2. 3.
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3SETUP OPTIONS 3
3.1 MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS
A Objectives
When you have completed this topic, you will be able to: B Describe the setup options available on the Miscellaneous screens. B Set up the eight instrument operations on the General screen: Auto-Numbering, Default Panel, Worklist Match Options, Logs (comment prompts), RUO Parameters, Manual Match, Auto-Stop for QA Messages, and Auto-Stop for Consecutive Results. B Set up and edit patient locations and physicians in the database. B Select the appropriate reporting format for the numeric results.
B References
Setup Menu Options under Heading 5.12 MENU PATHS. Heading A.4 OPERATIONAL SETUP.
1. 2. The instrument must be powered up. Either an Supervisor or Service must be logged in to access the Setup options.

1. Access the Miscellaneous setup options screens. From the Main menu, click 2. 3. tt .
Point out the three tabs, General, Location/Physician, and Units, clicking on each if desired, but return to the General screen. The General screen allows you to set eight instrument operations. Explain each, having the trainee change settings if needed. Note: To change settings, (1) click accept the changes. a. Auto-Numbering 1) An auto-number is automatically assigned as the Sample ID if: a) b) You are using bar-code labels and the label is missing or cannot be read. A Sample ID is not entered or received (from the host) for a specimen. Note: That means that if you use Cass./Position as positive ID, the tubes are not bar-coded, and you do not create a Worklist (a list of orders on which you can assign Sample IDs), all samples are assigned an AUTO_SID. , (2) edit the setting, then (3) click to
2) 3)
An auto-numbered Sample ID is preceded by AUTO_SID. The AUTO_SID automatically increments by one from the previously assigned number.
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SETUP OPTIONS MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS
4)
For auto-numbering to restart on the initial number set on this field, you must select Erase Worklist (to erase the previous days Worklist) and Reset Autonumbering on the Login screen at the beginning of a New Workday. Auto-numbering is always on; you cannot disable it. You can, however, use the AUTO_SID field to change the starting number. a) b) The number can have up to 8 digits. Leading zeros are automatically deleted.
5) 6)
7) b.
For the new starting number to become effective you must select Reset Autonumbering on the Login screen at the beginning of a New Workday. You can choose which test panel, CBC or CBC/DIFF , is default. The default test panel is run automatically unless the panel selection is changed when the sample information is entered or received. A Worklist is used to assign a Sample ID, test panel, flagging set, and demographic information if desired, to a sample. The link between the information on the Worklist and the sample results is referred to as the positive ID. Using the internal bar-code reader, the instrument can use one of two positive ID methods. a) b) It can read a bar-code label on the specimen tube, identifying the sample by the Sample ID encoded in the label. This is the recommended method. It can read the bar-code label on the cassette, identifying the sample by the cassette number and its position in the cassette. This method relies on the Operators accuracy in placing the tube in the correct cassette and position. Note: Even if you use this method, if the specimen tube has a bar-code label that label is read. It is just not used as the primary ID.
Default Panel 1) 2)
c.
Worklist Match Options 1) 2) 3)
4)
If you plan to use a Worklist, the Worklist Match Options allows you to select which positive ID method, Barcode or Cass./Position, to use as the primary ID. a) b) c) d) If all or most of your specimen tubes have bar-code labels, select Barcode. If your specimen tubes do not have bar-code labels, select Cass./Position. Whichever you select, the controls will be processed the same way.
Barcode is the default setting.
d.
Logs 1) If you select Calibration Log, after you have completed calibration a Comments window is automatically displayed for entering comments into the Calibration log. If you select Reagents Log, after you have replaced a reagent a Comments window is automatically displayed for entering comments into the Reagents log.
2)
3-2
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e.
RUO Parameters 1) The RUO (research use only) parameters on this instrument are PCT (plateletcrit), PDW (platelet distribution width), ATL (atypical lymphocytes) and IMM (immature cells). Disabled is the default setting. When Disabled is selected, PCT, PDW, ATL and IMM are inhibited; they are not displayed, printed, or transmitted. If you select Enabled - USA: a) b) c) 5) You must print and fill out an RUO form and send the completed form to Beckman Coulter as instructed. The @ label precedes the PCT, PDW, ATL and IMM parameters when they are displayed, printed, or transmitted The following message, For Research Use Only. Not for use in diagnostic procedures (RUO), is also displayed, printed, or transmitted.
2) 3) 4)
In the USA, you must either disable the RUO parameters or enable them for research use only. When you are using a Worklist, the instrument uses the positive ID (barcode or cassette/position number) to match the Worklist order with the appropriate sample results and automatically sends the results to the Results List. If the instrument cannot match the results and Manual Match is ON (enabled), the instrument: a) b) Sends the results to the Match screen for you to match. Flashes the Results icon, , to alert you.
f.
Manual Match 1)
2)
3)
If the instrument cannot match results and Manual Match is OFF (disabled): a) b) The instrument reports the sample as it is analyzed. If the Sample ID is unknown it assigns an AUTO_SID number.
4) 5)
Manual Match OFF is the default setting.
6)
7) g.
If you are using a Worklist, it is recommended that you enable the Manual Match option to ensure samples are reported with all the information on the Worklist order. If you are not using a Worklist, you may want to disable the Manual Match option to prevent the instrument from trying to match sample results with a non-existent Worklist order and sending all the results to the Match screen. The recommended scenario for running patient samples is to use bar-code labels on the tubes as the positive ID and to enable Manual Match ON. Whenever a QC Failed message (alarm) is triggered, you can elect to: a) Stop analysis of patient samples (Stop instrument on QC Failed message). b) Have the instrument post a QC Failed message in the tree view for the control that exceeded its limits and for any patient sample that is ran following that control sample (Display and Print QC Failed message).
Auto-Stop for QA Messages 1)
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2) h.
Whenever a XB/XM Failed message (alarm) is triggered, you can elect to stop analysis of patient samples (Stop instrument on XB/XM Failed message). The Auto-Stop for Consecutive Results feature allows you to select the number of consecutive results with certain characteristics that, if they occur, automatically stop the instrument. You can select from one to five consecutive results for one or more of the following characteristics: r r r r r r r MCHC >38 WBC Voteout RBC Voteout HGB Voteout HCT Voteout PLT Voteout DIFF+/DIFFr r r r WBC = 0 RBC = 0 HCT = 0 PLT = 0
Auto-Stop for Consecutive Results 1)
2)
3) 4)
A voteout indicates that when the two values derived for the analysis were compared, the difference exceeded a predetermined limit. A DIFF+/DIFF- indicates that when the WBC count derived in the flow cell was compared to the WBC count derived in the WBC/BASO bath, the difference exceeded a predetermined limit.
4.
Click the Locations/Physicians tab. a. b. The Locations/Physicians screen allows you to add patient locations and physicians names to the database, to edit them, and to delete them from the database. Point out the four fields on the left side of the screen. 1) 2) 3) c. 1) 2) 3) d. The Location field allows you to enter a new location or edit a current location. The next two fields are filled in automatically by the instrument. The box on the bottom displays the locations currently in the database. The Physician field allows you to enter a new location or edit a current physicians name. The next two fields are filled in automatically by the instrument. The box on the bottom displays the physician names currently in the database.
Point out the four fields on the right side of the screen.
Help the trainee find the procedure, Adding/Editing Physician and/or Location, in Appendix A.4 of the Online Help System or the Instructions for Use manual, and let them use the procedure to add locations and physicians names to the database. The Units screen allows you to select the format for reporting the numeric results.
US is the default setting.
5.
Click the Units tab. a. b. c.
The formats of each of the available Reporting Unit is shown in Table A.3 in the Online Help System or the Instructions for Use manual.
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SETUP OPTIONS QUALITY ASSURANCE SETUP OPTIONS
3.2
QUALITY ASSURANCE SETUP OPTIONS

A Objectives
When you have completed this topic, you will be able to: B Describe the options available from the Quality Assurance Options screen. B Explain the advantage of using multiple shifts. B Set up shifts for the laboratory if desired. B Modify the default CV limits for controls.
B References
In the Online Help System or the Instructions for Use manual, refer to: r
r Setup Menu Options under Heading 5.12 MENU PATHS Heading A.5 QUALITY ASSURANCE SETUP
1. 2. The instrument must be powered up. Either a Supervisor or Service must be logged in to access Setup options.

1. Access the Quality Assurance setup options screen. From the Main Menu, click 2. 3. tt .
Point out the two tabs, Shifts and QA Settings. Click the Shifts tab to display the Shifts screen. a. b. c. d. e. The Shifts screen allows you to define times for up to three shifts, Shift 1, Shift 2, and
Shift 3. Shift 0 is a 24-hour shift. When it is selected, no additional shift settings are needed. Shift 0 is the default setting.
Control results can be filtered and displayed by shift. If this laboratory wants to use multiple shifts, help the trainee find the procedure,
Selecting Shifts, in Appendix A.5 of the Online Help System or the Instructions for
Use manual, and use the procedure to define the laboratorys shifts. 4. Click the QA Settings tab to display the QA Settings screen and review the options available on this screen. a. As you review the options on the QA Settings screen, determine if the laboratory already has the information needed. r r If they do, have the trainee make the changes using the appropriate procedure in Appendix A.5 of the Online Help System or the Instructions for Use manual. If they do not, leave the settings at default and make sure the trainee knows where the procedures are for making the changes.
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SETUP OPTIONS QUALITY ASSURANCE SETUP OPTIONS
b.
XB/XM Options 1) 2) 3) 4) Allow you to enable or disable the XB or XM quality control options.
OFF is the default setting.
Information about the XB/XM method of monitoring instrument performance is available in the Topic, XB/XM, in Chapter 4. To change the selection see the procedure, XB/XM Options (Enabling/Disabling), in Appendix A.5. Allows you to enter the minimum number of runs the laboratory will accept. The number 5 is the default. Information about calibration is available in the Topic, Calibration, in Chapter 5. To change the setting see the procedure, Minimum Runs Required for Auto-Calibration (Defining), in Appendix A.5. Allows laboratories participating in the IQAP program to enter or change the IQAP ID received with their enrollment confirmation information. Information about the IQAP method of monitoring instrument performance is available in under Heading 4.5, INTERLABORATORY QUALITY ASSURANCE (IQAP) in this Training guide. To enter or change the setting see the procedure, IQAP ID (Entering/Editing), in Appendix A.5. Calibration results are compared to the CV limits listed for calibration. To ensure the instrument is performing to specifications, it is strongly recommended that you leave the Calibration CV limits set to the default values. The values in the cell control files are compared to the CV limits listed for QC. To change the CV limits for controls, see the procedure, CV Limits for Calibration, QC, and Reproducibility, in Appendix A.5. Reproducibility results are compared to the CV limits listed for Reproducibility. To ensure the instrument is performing to specifications, it is strongly recommended that you leave the Reproducibility CV limits set to the default values.
c.
Minimum Runs for Automatic Calibration 1) 2) 3) 4)
d.
IQAP ID 1) 2)
3) e.
CV Limits (Calibration, QC, Reproducibility) 1) 2) 3) 4) 5) 6)
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SETUP OPTIONS AUTO FUNCTIONS SETUP OPTIONS
3.3
AUTO FUNCTIONS SETUP OPTIONS

A Objectives
When you have completed this topic, you will be able to: B Describe the options available from the Auto Functions screen. B Set up the instrument to automatically rerun selected specimens. B Set up the instrument to automatically print selected patient results. B Set up the instrument to automatically transmit selected patient results.
B References
r Setup Menu Options under Heading 5.12 MENU PATHS Heading A.7 AUTO-FUNCTIONS SETUP

1. Access the Auto Functions setup screens. From the Main Menu, click 2. tt .
Point out the three tabs, Rerun, Auto-Print, and Auto-Transmit, clicking on each if desired, but return to the Rerun screen. a. b. The Rerun screen allows you to mark a specimen for an automatic rerun. When a sample meets the defined criteria for an automatic rerun, a new Worklist order is created, and the instrument automatically reruns the specimen. 1) 2) c. 1) 2) d. Both the original and the rerun results are available for viewing. On the printed patient report for the rerun, Yes appears by Rerun. Flags are symbols, sets of symbols, letters, or text generated by the instrument to signal a parameter may need additional review. The parameter flags for a rerun are listed on the left side of the screen. Be prepared to explain these flags if asked.
A rerun can be based on the parameter flags generated.
A rerun can be based on parameter characteristics such as voteouts, exceeding patient limits (H or L), or exceeding action limits (HH or LL). 1) 2) Patient limits and action limits are defined by the laboratory to signal a parameter may need additional review. Parameter characteristics that can be selected are listed on the right side of the screen.
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SETUP OPTIONS AUTO FUNCTIONS SETUP OPTIONS
e.
The rerun criteria can be applied to one or all flagging sets. 1) 2) A flagging set is a set of patient limits and action limits selected by the laboratory for a specific group of patients, such as neonates. The flagging sets available are listed in the Flagging Set drop-down menu.
3.
Click the Auto-Print tab. a. b. The settings selected on the Auto-Print screen define which patient results are automatically printed after analysis. You can elect to turn the Auto-Print option OFF and not print any samples automatically, to print All sample results, to print Normals only, or to print Selected Abnormals. When you select Selected Abnormals, the list of abnormal results to choose from becomes active. You can select one or more of the abnormal criteria. 1) 2) 3) 4) 5) d.
No Parameter Value. Prints all patient results without a value. With Parameter Flags. Prints all patient results with a parameter flag. With Histo & DiffPlot Flags. Prints all patient results with a histogram flag and a
c.
DiffPlot flag.
Outside Patient Limits. Prints all patient results outside patient limits (flagged
with H or L).
Outside Action Limits. Prints all patient results outside action limits (flagged with
HH or LL). Determine if the laboratory wants to use the Auto-Print function. If they do, have the trainee find the procedure, Setting the Auto-Print Options for Patient Results, in Appendix A.5 of the Online Help System or the Instructions for Use manual, and use the procedure to select the Auto-Print functions. The settings selected on the Auto-Transmit screen define which patient results are automatically transmitted (sent) to the host computer after analysis. You can elect to turn the Auto-Transmit option OFF and not transmit any samples automatically, to transmit All sample results, to transmit Normals Only, or to transmit Normals and Selected Abnormals. When you select Normals and Selected Abnormals, the list of abnormal results to choose from becomes active. You can select one or more of the abnormal criteria. 1) 2) 3) 4) 5) d.
No Parameter Value. Transmits all patient results without a value. With Parameter Flags. Transmits all patient results with a parameter flag. With Histo & DiffPlot Flags. Transmits all patient results with a histogram flag and
4.
Click the Auto-Transmit tab. a. b.
c.
a DiffPlot flag.
Outside Patient Limits. Transmits all patient results outside patient limits (flagged
with H or L).
Outside Action Limits. Transmits all patient results outside action limits (flagged
with HH or LL). Determine if the laboratory wants to use the Auto-Transmit function. If they do, have the trainee find the procedure, Setting the Auto-Transmit Options for Patient Results, in Appendix A.5 of the Online Help System or the Instructions for Use manual, and use the procedure to select the Auto-Transmit functions.
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SETUP OPTIONS SYSTEM SETUP OPTIONS
3.4
SYSTEM SETUP OPTIONS

A Objectives
When you have completed this topic, you will be able to: B B B B B B B Describe the options available from the System screens. Set the date and time displayed at the Workstation. Locate the procedures for changing the Workstation for non-English speaking locations. Set up the instrument to automatically print non-patient results. Customize your laboratorys printed patient report form. Set up the instrument to automatically do Auto-Clean, Startup, and Shutdown cycles. Define a New Workday and explain its significance.
B References
r Setup Menu Options under Heading 5.12 MENU PATHS Heading A.8 SYSTEM SETUP

1. Access the System setup screens. From the Main Menu, click 2. 3. tt .
Point out the four tabs, Local Settings, Host, Printer, and Cycle Options, clicking on each if desired, but return to the Local Settings screen. The Local Settings screen allows you to set up the instrument for the time, date, and language of the instruments current location. a. b. The Current Date/Time fields allow you to set the current date and time at installation and to adjust the time for changes, such as daylight savings time. The Date/Time Format fields allow you to select the date and time display format. 1) 2) c.
MM/dd/yyyy (month/day/year) is the default date format. HH:mm:ss (hours:minutes:seconds) is the default time format.
d.
Help the trainee find the procedure, Changing the Current Date/Time and Date/Time Format, in Appendix A.8 of the Online Help System or the Instructions for Use manual, and use the procedure to adjust the date and time as needed. The Language box allows you to select the language displayed by the Workstations software. 1) The language selections are English, French, German, Italian, and Spanish. 2) English is the default setting.
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3)
The procedure for changing the software language immediately follows the procedure for changing the date and time in Appendix A.8 of the Online Help System or the Instructions for Use manual.
4.
Click the Host tab. a. b. The LIS/HIS communication settings on the Host screens configure the ACT 5diff instrument for communications with (to and from) the laboratorys host computer. Typically, the laboratory decides what information needs to be transmitted and then a qualified technician uses the information in the Host Transmission Specification manual to define the correct settings for the laboratorys system. The Printer screen allows you to define four print options: 1) 2) 3) 4) b. 1) The Printer in use The non-patient results that automatically print The contents of the printed patient report header The information included on the printed patient report. Allow you to add or delete a Printer from the available Printer list. a) b) 2) 3) 4) 5) Use Printers available in the Printer list because those Printers and their drivers have been validated for use with the ACT 5diff AL system. Do not delete a Printer unless instructed to do so.
5.
Click the Printer tab. a.
The options in the Printer box on the left side of the screen:
Allow you to access the Windows-NT Printer Properties window and change the paper size, print quality, and number of copies. Allow you to select the default Printer. Are set by Service at installation. Can be changed using the Add Printer, Printer Properties, Set Default Printer, or Delete Printer procedures in Appendix A.8 of the Online Help System or the Instructions for Use manual. Allows you to choose to automatically print any of the following at the completion of analysis: Quality Control Results, Reproducibility Results, Calibration Results, and Startup results. If the laboratory wants to print any of these results automatically, have the trainee find and use the procedure, Auto-Print (Non-Patient Results), in Appendix A.8 of the Online Help System or the Instructions for Use manual. Six header fields, 20 characters each, are available for adding header information. If the laboratory plans to use a customized report header, have the trainee find the procedure, Report Header (Entering/Editing), in Appendix A.8 of the Online Help System or the Instructions for Use manual, and type in the header.
c.
The Autoprint box in the middle of the screen: 1)
2)
d.
The Report Header fields allow you to customize the header on the patient report. 1) 2)
e.
The remaining boxes on the Printer screen allow you to select the information that will be printed on the full patient report.
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1)
The Enable box allows you to include any of the following: Note: With the exception of Raw Data, all selections are enabled by default. a) b)
Ranges. Normal ranges for each parameter reported. Raw Data. The raw values collected during analysis.
c) d)
e) 2)
Note: This data can be useful as a troubleshooting tool, but do not enable this option unless instructed by your Beckman Coulter Representative. Microscopic Examination Area. A labeled area where results of the microscopic examination can be added. Messages. Interpretive messages, such as Anemia when the Hgb < Hgb LL. For more information, refer to Interpretive Messages under Heading 9.8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT, in the Online Help System or the Instructions for Use manual. Histogram and DiffPlot. The histograms and DiffPlots generated as part of the sample analysis.
The Display and Print Detailed Flags option allows you to choose between printing (and displaying) detailed flags or suspect flags for a parameter. a) b) c)
Detailed Flags enabled is the default.
As a general rule the detailed flag is more parameter specific, the suspect flag more generic. To see the differences, refer to Suspect Flag Format under Heading 9.8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT, in the Online Help System or the Instructions for Use manual.
3) 4)
The Hematology Parameters Printed box allows you to select the whole blood parameters to include on the report. Have the trainee find the procedure, Patient Report Setup, in Appendix A.8 of the Online Help System or the Instructions for Use manual, and make the relevant selections for their laboratory.
6.
Click the Cycle Options tab. a. The Cycle Options screen allows you to define five cycle options. Explain each, having the trainee change settings if needed. Note: To change settings, (1) click accept the changes. b. Auto-Clean 1) 2) 3) 4) c. 1) The Auto-Clean field allows you to enter the number of analyses between automatic Auto-Clean cycles. In the Auto-Clean cycle, Rinse reagent is dispensed to the bath assemblies to clean the bath assemblies and the apertures, and then flushed out with Diluent. You can select an interval from 1 to 120 analyses between Auto-Clean cycles. The default number is 100. The Daily Workload fields allow you to enter the number of CBC and CBC/DIFF samples typically ran in a day. , (2) edit the setting, then (3) click to
Daily Workload
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2) 3) 4) 5) d. 1) 2) 3) 4)
The system uses these numbers at the end of Startup to determine if the reagent volume available is sufficient for the workday. If the system determines the reagent volume is insufficient it generates the message, Reagent(s) Low. Insufficient Reagent to Complete Daily Workload. The Daily Workload can be set from 1 to 500 cycles. The default values are: CBC/DIFF Runs per Day, 40; CBC Runs per Day, 10. Allows you to define the beginning of a new 24-hour workday. A Shutdown must be done before a New Workday becomes effective. For the system to check for a New Workday, you must quit (click ) the system software. If the system determines that the conditions for a New Workday are met, it displays the following options on the Login screen: Erase Worklist. Erases the Worklist. Reset Autonumbering. Resets the Auto-Numbering to the starting number defined on the Miscellaneous Setup, General screen. Archive Results. Archives any results on the Results list. Archive Unmatched Results and Delete Worklist. This option only appears if unmatched results are present on the Match screen. Places all unmatched results from the Match screen into the archive and deletes the current Worklist. Unmatched appears in the Miscellaneous Messages section of the Flags and Messages area of the report for the unmatched results. Database Maintenance. Deletes patient records that do not have corresponding results, compacts the database, stores the last 1,000 raw results, and backs up the database. If the system determines that the conditions for a New Workday are met, regardless of the options selected on the Login screen, it automatically: a) b) c) Deletes as many old records as necessary until the database totals 9,500. This happens only if the database exceeded 10,000 records at Startup. Checks all reagent volumes at the end of the first Startup cycle to ensure there is enough reagent to process the days work. Saves a backup of the database in a different directory.
New Workday
5)
e.
Startup 1) 2) 3) Allows you to enable or disable an automatic Startup cycle. When Automatic is selected (enabled), a Startup cycle is done automatically whenever the system is powered up. It is recommended that you keep the Automatic Startup option enabled. Allows you to enable or disable an automatic Shutdown cycle. When Automatic is selected (enabled), a Shutdown cycle is done automatically at the time entered in the field.
f.
Shutdown 1) 2)
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SETUP OPTIONS CONFIGURATION SAVE AND RESTORE SETUP OPTIONS
3.5
CONFIGURATION SAVE AND RESTORE SETUP OPTIONS

A Objectives
When you have completed this topic, you will be able to: B Describe the options available from the Config. Save/Restore screen. B Locate the procedures for saving and restoring the Analyzer and Workstation configurations in the Online Help System or the Instructions for Use manual. B Locate the procedure for deleting all or part of a patient database.
B References
r Setup Menu Options under Heading 5.12 MENU PATHS Heading E.2 CONFIGURATION: ANALYZER AND WORKSTATION
1. 2. The instrument must be powered up. Either a Supervisor or Service must be logged in to access the setup options.

1. Access the Config. Save/Restore screens. From the Main Menu, click 2. 3. tt .
Point out the two tabs, Configuration and Delete Database. Click the Configuration tab to display the Configuration screen. a. The options in the Analyzer Configuration box allow you to save (and to restore if necessary) the Analyzer Configuration settings. 1) 2) 3) It is recommended that you save the information to a floppy disk. Service saves the Analyzer configuration to a floppy disk at installation. To save or restore the Analyzer configuration, refer to the procedures, Analyzer Configuration: Save to Hard Disk/Save to Floppy Disk, and Analyzer Configuration: Restore from Hard Disk/Restore from Floppy Disk, in Appendix E.8 of the Online Help System or the Instructions for Use manual.
b.
The options in the Workstation Configuration box allow you to save (and to restore if necessary) the Workstation Configuration settings. 1) 2) 3) It is recommended that you save the information to a floppy disk. Service saves the Workstation configuration to a floppy disk at installation. To save or restore the Workstation configuration, refer to the procedures, Workstation Configuration: Save to Hard Disk/Save to Floppy Disk, and Workstation Configuration: Restore from Hard Disk/Restore from Floppy Disk, in Appendix E.8 of the Online Help System or the Instructions for Use manual.
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SETUP OPTIONS OPERATORS SETUP OPTIONS
4.
Click the Delete Database tab to display the Delete Database screen. a. The Delete Database screen allows you to delete all or part of the patient database. 1) Deletion is based on a date selected by the Operator. a) b) 2) 3) 4) b. c. The calendar on the left allows you to select the run date up to and including which all patient data will be deleted. To delete the entire database, select the last date sample results were archived.
The Delete Data On/Prior to Selected Date button deletes the data. A deleted database cannot be restored. The rest of the Delete Database screen displays the history of the last deletion and of the current deletion.
To delete all or part of a patient database, refer to Procedure to Delete Existing Database, in Appendix E.8 of the Online Help System or the Instructions for Use manual. To delete individual results or patients from the database, refer to Heading 9.6 DELETING ARCHIVED PATIENT RESULTS, in the Online Help System or the Instructions for Use manual.
3.6
OPERATORS SETUP OPTIONS

A Objectives
When you have completed this topic, you will be able to: B Use the Operators screen to set up users for the system.
B References
r Setup Menu Options under Heading 5.12 MENU PATHS Heading A.9 OPERATOR (USERS) SETUP
1. 2. The instrument must be powered up. Either a Supervisor or Service must be logged in to access Setup screens.

1. Access the Operators setup screen. From the Main Menu, click 2. a. b. tt .
The left side of the Operators screen displays the current users in the system. The ACT 5diff system has three levels of users: Service, Supervisor, and Operator. Each level of user has different access rights to the system. 1) Service has full access to the system.
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SETUP OPTIONS OPERATORS SETUP OPTIONS
2) 3) 3.
Supervisors do not have access to Service function screens. Operators do not have access to Service function screens, Setup screens, or the Calibration screen.
The right side of the Operators screen gives the details for the user selected in the Users List and allows Service or a Supervisor to edit, add, or delete users. a. b. Service can edit, add, and delete both Supervisors and Operators. Supervisors can edit, add, and delete Operators; edit, add, and delete other Supervisors; and edit themselves but they cannot delete themselves. A Login Name is required for all users. 1) 2) When a user is in the system, the users Login Name is on the Login Name drop-down menu on the Login screen. The Login Name is used for traceability. When the user logs into the system, the users Login Name appears at the bottom of the screen and is attached to all system events until the user logs out. The Login Name can be up 10 alphanumeric characters. An Operator must also use a password if one is entered for them in the Password field. The Password can be up to eight alphanumeric characters.
4.
When adding a user to the Users List: a.
3) b. 1) 2) c. d.
A Password is required for Service and Supervisors only.
The Group drop-down menu lists the user access levels available for selection:
Operator, Supervisor, or Service.
A three-character Operator code is required for all users. 1) 2) 3) This code can be the users initials, a code assigned by you, or any other three-character combination that will distinguish this user from other users. This code is used in the software to identify the Operator who was logged on when the task or cycle was performed. This code is required for certain transmit to host formats.
5.
When editing a user on the Users List: a. b. c. You can only edit the Users Login Name, the Password, and the Operator code. The Group drop-down menu is not active in the Edit mode. To change a users group (Operator, Supervisor, or Service) you must delete the user and then add them again with the new user designation.
6.
Have the trainee find the procedure, Operators (Users): Adding/Editing/Deleting, in Appendix A.9 of the Online Help System or the Instructions for Use manual, and add the laboratorys users to the User List.
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SETUP OPTIONS FLAGGING SETS SETUP OPTIONS
3.7
FLAGGING SETS SETUP OPTIONS

A Objectives
When you have completed this topic, you will be able to: B Describe the options available from the Flagging Sets screen. B Locate the procedure for editing pre-defined flagging sets. B Locate the procedure for creating a new flagging set.
B References
r Setup Menu Options under Heading 5.12 MENU PATHS Heading A.10 FLAGGING SETS SETUP
1. 2. The instrument must be powered up. Either a Supervisor or Service must be logged in to access Setup menus.

1. Access the Flagging Sets setup screen. From the Main Menu, click 2. tt .
The left side of the Flagging Sets setup screen displays the flagging sets available and the flagging set selected as default. a. A flagging set is a set of patient limits and action limits selected by the laboratory for a specific group of patients. 1) 2) The groups can be based on age or gender. Eight of the flagging sets are pre-defined and installed: Standard Range, Man,
Woman, Child 1, Child 2, Child 3, Child 4, and Child 5.
a) b) 3)
All of the pre-defined ranges except the Standard range can be edited to best fit your laboratorys needs. All of the pre-defined ranges can be copied and applied to other flagging sets. When you create a new flagging set, the Standard Range patient and action limits are applied. You can edit these patient and action limits, or you can copy the patient and action limits from another flagging set and apply them.
You can create up to 12 additional flagging sets for a total of twenty. a) b)
b. c. 3. 3-16
The flagging set to use for a specimen is entered on the Worklist. This is discussed under Flagging Sets in Chapter 5, Sample Analysis. The default flagging set is used when a flagging set is not selected for a specimen.
Point out the two tabs, Flags and Messages and Flag Sensitivity and Thresholds.
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a.
Click the two tabs alternately, noting that only the data on the right of the screen changes, switching from patient and action limits to flag sensitivity and thresholds settings. The data displayed on the right is always for the flagging set selected on the left.
b.
IMPORTANT Do not make any adjustments to the flag sensitivities or the thresholds without first consulting your Beckman Coulter Representative. Otherwise, your system may not perform to specifications. Any change to thresholds or sensitivity affect overall system performance.
c. d. e. f. 4. a.
The options in the Flag Sensitivity and Thresholds box are for Service use only. The options in the Flags and Messages box allow you to check, and edit if desired, the patient limits and action limits for the flagging set selected. In the Flagging Sets box on the left side of the screen, click on one of the Child flagging sets. Note that now a third tab, Age Ranges, is displayed. The Age Ranges box allows you to edit the patient age defined for Child 1, Child 2, Child 3, Child 4, and Child 5.
Click on the Age Ranges tab.
IMPORTANT Due to the systems calculation methods for determining the age from the date of birth, the precision of the age calculation is limited to 1 day. When the age is close to the limit of a flagging range, the adjoining flagging range may be selected.
b.
You cannot type an age into the age field. 1) 2) You use the slider to change the age. You press or to adjust the age by one day.
c. 5.
You cannot make the next flagging set younger than the former. For example, Child 2 cannot be younger than Child 1.
In the Flagging Sets box, have the trainee select each flagging set and check the patient limits, the action limits, and the defined age where it applies, for that flagging set. a. If any of the flagging sets need to be changed, or more flagging sets need to be added, help the trainee find and use the appropriate procedures under A.10, FLAGGING SETS SETUP , in the Online Help System or the Instructions for Use manual, to make the changes. If the flagging sets meet the laboratorys current needs, just make sure the trainee knows where to find the procedures for setting up and editing the flagging sets. Help them find A.10, FLAGGING SETS SETUP, in the Online Help System or the Instructions for Use manual.
b.
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4QUALITY ASSURANCE 4
4.1 SETTING UP OR MODIFYING CELL CONTROL FILES
A Objectives
When you have completed this topic, you will be able to: B Set up a new cell control file. B Locate the procedure for modifying an existing control file.
B References
1. 2. In the Online Help System or the Instructions for Use manual, refer to Heading A.6
SETTING UP A CONTROL FILE.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the CONTROL FILE SETUP AND MODIFICATION SUMMARY.
1. 2. The instrument must be powered up. Control material with assay values (either printed or on disk) must be available.

1. The Analyzer can analyze control material, determine if its results are within specified limits from its assay values, maintain running means of the results, calculate the 2SDs and CVs, and plot the data points on Levey Jennings graphs for each parameter. a. b. To do this a control file must be set up for each control that will be processed. Files can be set up for up to 24 control lots. 1) 2) c. 2. 1 through 12 are reserved for CBC controls. 13 through 24 are reserved for CBC/DIFF controls.
Beckman Coulter recommends running all three levels (Low, Normal, and High) of the ACT 5diff Control Plus to monitor the CBC and DIFF parameters.
Unlike the rest of the instrument setup options, the control file setup screen is not accessed through the setup menu. a. b. Click tt to access the control file screen.
The screen used to access and setup new control files is the same screen used to modify the control file setup, and to review and manage control file data. 1) 2) 3) Note the right side of the screen displays the Levey-Jennings graphs. Click and the right side of the screen displays the control data in tables.
Click tt Target tab and the right side of the screen displays the area for entering the assay values for the control.
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QUALITY ASSURANCE SETTING UP OR MODIFYING CELL CONTROL FILES
3.
Help the trainee find Heading A.6 SETTING UP A CONTROL FILE, in the Online Help System or the Instructions for Use manual, and set up their control files. a. If the instrument has the optional Barcode Scanner and the control vials have a bar-code label, demonstrate how to use the Barcode Scanner correctly. The instructions for using the Barcode Scanner are under Heading 5.6, WORKING WITH BAR-CODE LABELS, in the Online Help System or the Instructions for Use manual. b. Emphasize the importance of selecting the Reserved option, reserving the control lot number as the Sample ID for that control. 1) 2) Reserved is the default setting. If the control lot number is reserved as the Sample ID, the system recognizes the Sample ID as being a control and places the control results in the correct control file. If the control lot number is not reserved as the Sample ID, the system does not recognize the Sample ID as being a control and places the results in with the patient sample results. The screen that happens to be displayed when running a control has no affect on the placement of the control results.
3)
4) c. 4.
If your laboratory establishes its own running means and expected ranges for the control results, you can modify this setup accordingly.
If you modify the control file setup after data is in the file, that event is logged in the Quality Control Log. a. From the Main Menu screen, click 1) 2) 3) 4) b. tt to access the Quality Control Log.
The most recent entry is displayed on the top of the log screen. The log entry includes the date and time of the event, the name of the Operator logged in, and the lot number and expiration date of the control and the event. The Quality Control Log saves entries for up to one year. Prior entries to the log are deleted on a first in, first out basis as the capacity is exceeded.
To add comments to an entry (up to 50 alphanumeric characters), click on the entry and then on the Add Comments button.
5.
Give the trainee a copy of the CONTROL FILE SETUP AND MODIFICATION SUMMARY from this Training Guide. This summary has two procedures; review the procedure for setting up a control file and then go over the procedure for modifying a control file.
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QUALITY ASSURANCE ANALYZING CELL CONTROLS
4.2
ANALYZING CELL CONTROLS

A Objectives
When you have completed this topic, you will be able to: B Explain the storage and handling requirements. B State the open-vial stability. B Define an event. B State indications of instability or deterioration. B Prepare and run ACT 5diff Control Plus in both the Autoloader and the Manual mode. B Recognize an out-of-limit result on the Quality Control screen.
B References
r r r Heading 7.2 QUALITY CONTROL (QC) Heading 7.3 RUNNING CELL CONTROLS Heading 7.5 DELETING QC RUNS/FILES
2. 3.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the CONTROL ANALYSIS SUMMARY. Obtain a copy of the package insert for the cell controls.
1. 2. The instrument must be powered up and the Startup procedure completed. Control material with control files already set up in the system are needed.

1. Cell controls are used to monitor instrument performance. a. b. c. d. 2. By comparing the control results against the assay (known) value, you can determine your instruments accuracy. By running more than one level of control you can verify the instruments linearity over a range of values. Accurate control results depend not only on the instrument condition but also on the stability of the control material itself and how it is stored and handled. Beckman Coulter recommends COULTER ACT 5diff CONTROL PLUS (low, normal, and high) as a stable reference control for use with this instrument.
Determine if this is the first time the trainee is using the recommended ACT 5diff CONTROL PLUS cell controls. If the answer is yes: a. Review the storage, handling, and mixing procedures documented on the package insert, emphasizing the correct mixing procedure.
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b.
Make sure the trainee is aware of the following: 1) Open-vial stability is listed according to days or events. An event has occurred anytime an Operator completes the following sequence: a) b) c) d) e) 2) a) b) 3) Removes a control vial from the refrigerator Allows the control vial to stand at room temperature 15 minutes Mixes the control vial gently by hand using the 8 x 8 x 8 method two times Aspirates sample Returns the control vial to the refrigerator within 30 minutes Inability to obtain expected values in the absence of known instrument problems Gross hemolysis (darkly colored supernatant) Note: This condition is documented on the assay sheet. A slight pink color to the supernatant is normal. Note: This condition is documented on the assay sheet. The RBC and PLT parameters may trend over the controls expiration dating. In the Autoloader mode, you must run the control with the cap on. In the Manual mode, it is recommended that you run the control with the cap on to prevent spillage and reduce biohazard exposure.
The conditions that indicate deterioration:
The conditions that do not indicate deterioration. a) b)
4)
The control is designed with a pierceable cap so you can run it with the cap on. a) b)
5) 3.
Although control levels may be run in any order, Low, Normal, then High provides the best statistical results.
To print a full report of a controls results, including the parameter results with expected ranges and parameter histograms, Auto-Print for controls should be enabled. a. The screen display from which you can manually print a full report is only available until the next control is analyzed; so if Auto-Print is not enabled it is likely that you will miss printing a full printout on some of your controls. Determine if the laboratory needs or wants a full report of the controls results. Selecting the Auto-Print options for non-patient results is covered under Heading 3.4, SYSTEM SETUP OPTIONS, in this Training Guide. To view the current Auto-Print setting, from the Main Menu click Printer tab. tt tt
b. c.
d. 4.
Help the trainee locate Heading 7.3 RUNNING CELL CONTROLS, in the Online Help System or the Instructions for Use manual. a. This section covers three procedures for running cell controls: 1) 2) 3) Running Cell Controls: Autoloader Mode With Barcode ID Running Cell Controls: Autoloader Mode Without Barcode ID Running Cell Controls: Manual (Stat) Mode.
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b.
Cell controls are run in the Autoloader mode using the same positive ID as the patient samples. 1) 2) From the Main menu, click tt tt General tab to determine which positive ID method, Barcode or Cass./Position, the laboratory is setup to use. If the laboratory has Barcode selected, the trainee should use the Running Cell Controls: Autoloader Mode With Barcode ID procedure. Note: Do not be concerned if your laboratory is using barcode as the positive ID but the control vials do not have bar-code labels. The results will go on the Match screen where you can manually match the control results to the control Sample ID. 3) If the laboratory has Cass./Position selected, the trainee should use the Running Cell Controls: Autoloader Mode Without Barcode ID procedure. Note: Do not be concerned if your laboratory is using cassette number and position as the positive ID but the control vials have bar-code labels. The Analyzer will read the labels but will not use them as the primary ID.
ATTENTION: You need data in the control files to discuss the elements of the control file screens. If new control files have just been set up, use this next step to enter information into the new files.
5.
Have the trainee run controls in the Autoloader mode, using the appropriate procedure. a. b. If the instrument is set up to automatically print control results, a report is printed. Results of the last control sample ran can be viewed in two places, the Run in Progress screen and the QC Graphics screen.
c.
On the Main Menu screen, click 1) 2)
to display the Run in Progress screen.
The Run in Progress screen shows the last sample analyzed, whether it is a background count, a control, or a blood sample. This screen displays the control results like a patient sample, with parameter results and histograms. tt tt to display the QC
d.
From the Main Menu screen, click Graphics screen. 1) 2)
The QC Graphics screen shows the last control sample analyzed. This screen displays the control results for each parameter and the histograms. a) b) If a result exceeds the low limit of the expected range, an L is displayed next to the result and the result and flag are backlit red. If a result exceeds the upper limit of the expected range, an H is displayed next to the result and the result and flag are backlit red.
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3)
For a detailed description of the QC Graphics screen, refer to Understanding the QC Graphics Screen, under Heading 7.3 RUNNING CELL CONTROLS In the Online Help System or the Instructions for Use manual. to display the QC screen and explain the
6.
From the Main Menu, click tt screen elements of the QC screens. a. b.
The file selected in the Control Name or the Lot Number box on the left side of the screen determines which controls data is displayed on the right side. When the QC screen is first displayed, Levey-Jennings graphs are displayed on the right side of the screen. 1) Three Levey-Jennings graphs are displayed at a time. a) b) 2) a) b) 3) The tabs above the graphs (four for CBC controls and seven for CBC/DIFF controls) allow access to the remaining parameter graphs for that control. Click each of the tabs in turn, noting the graphs that appear for each. The last data point included in the graph is located on the far right. Data points are not displayed for control runs that are excluded from the control file. A central line representing the actual mean value for that parameter A line above mean value (central line) represents the upper limit and a line below the mean value represents the lower limit boundaries Area showing dashes is the out-of-limit area.
Selecting a data point on a graph displays the results for that data point.
Each graph contains three areas. a) b) c)
c.
For a detailed description of the Levey-Jennings Graphs screen, refer to

Understanding the QC Levey-Jennings Graph Screen, under Heading 7.3 RUNNING CELL CONTROLS In the Online Help System or the Instructions for Use manual.
d.
In the Contextual toolbar at the bottom of the QC Graphics screen, click display the QC Data Grid screen.
to
Note: Clicking alternates the control data presentation on the right side of the QC Data screen between graphs and tables. e. On the QC Grid screen, control data is displayed in tables. 1) Control file storage is unlimited. a) b) 2) The most recent control results are displayed as the last set. You can scroll to see older data.
The control results are compared to the target values and expected ranges entered into the system when you set up the control file. a) b) When a result exceeds the low limit, an L is displayed next to the result and the result and flag are backlit red. When a result exceeds the upper limit, an H is displayed next to the result and the result and flag are backlit red.
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c) 3)
An R, V, or S against a red background indicates two flags were generated, the R, V, or S shown and an H or L not shown but indicated by the red.
If the instrument determines a control run had an analytical error, the control run is rejected. a) b) c) A rejected analysis is stored and a notification is sent to the Quality Control Log with an automatic comment of Analytical Error. Samples with analytical errors are deselected by default and not included in the statistical calculations.
4)
If a result with a non-numerical parameter result is manually selected for inclusion in the statistics, the values replaced by the non-numeric flag are included in the statistical calculations even though the parameter is shown as a non-numerical flag on the table. An exception to the fact that the instrument rejects (deselects) a control run with an analytical error is the analytical error generated when the ACT 5diff Control Plus cell control is analyzed for BA% and BA#. a) Due to the technology used and the nature of the control material, the basophil analysis generates a BASO+ analytical alarm and causes the BA% and the BA# to be inhibited on the Run-in-Progress screen, just as a patient sample with the same results would be inhibited. To permit assessment of the BA parameter performance, the BA% and the BA# results are not deselected for the control results. The BA% and the BA# results are, however, posted to the control file with an S next to the results to indicate the results would have been suppressed for a patient sample. The S-flag prints on the QC report when printed from the QC Data Grid screen.
b) c)
a) 5)
The control results are also analyzed with the control data already accumulated in the file to determine the mean, 2SD, and %CV of the file data. a) b) The mean of the selected control results are displayed in red if greater than the high targets, and displayed in yellow if lower than the low targets. When a % CV exceeds the QC CV limit for that parameter, the parameter field containing the out-of-limit %CV value is backlit red.
6)
The laboratory can establish their own CV limits for controls and enter them on the Quality Assurance setup options screen. a) Entering customized QC CV limits is covered under Heading 3.2, QUALITY ASSURANCE SETUP OPTIONS, in this Training Guide. To view the current values entered, from the Main Menu click tt QA Settings tab. tt
b)
7) 7.
For a detailed description of the QC Data Grid Graphs screen, refer to Understanding the QC Data Grid Screen, under Heading 7.3 RUNNING CELL CONTROLS.
Have the trainee review the results of each control just analyzed and determine if all the results are within the expected range.
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8.
If any of the control results are outside the expected range, it could be a control problem, a statistical outlier, or an instrument problem. a. b. Review the logic outlined under Heading 4.3, INTERPRETING AND USING CELL CONTROL DATA in this Training Guide to correct the problem. This information is also covered in Reviewing Control Results under Heading 7.3 RUNNING CELL CONTROLS, in the Online Help System or the Instructions for Use manual.
9.
When the control is out of range, the QC alarm is triggered. a. b. When the QC alarm is triggered, the Alarm screen. flashes and a QC Failed message is posted on
You can elect to have the instrument stop analyzing patient samples when a QC alarm is triggered. 1) Selecting Auto-Stop for a QC Failed message is covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide. Click tt tt General tab to see the current setting for this option.
2) c.
You can elect to have the instrument display (and print) a QC Failed message in the tree view for the control that exceeded its limits and for any patient sample ran following that control. 1) Selecting the display of a QC Failed message in the tree view (Display and Print QC Failed message) is covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide. 2) 3) Click tt tt General tab to see the current setting for this option.
Once triggered, the QC Failed message is displayed in the tree view of all patient samples until one of the following occurs: a) b) A QC analysis of the same control lot is ran and is within limits. All the QC data for the control lot that triggered the message is deleted.
10. The Operator may decide to exclude an analysis. a. b. Control results should only be excluded immediately if you can trace the unacceptable results to an Operator error. Excluding too many runs can cover up an instrument problem and bias results.
11. Have the trainee run controls in the Manual mode, using the Running Cell Controls: Manual (Stat) Mode procedure under Heading 7.3 RUNNING CELL CONTROLS, in the Online Help System or the Instructions for Use manual. 12. Give the trainee a copy of the CONTROL ANALYSIS SUMMARY from this Training Guide and review the procedures.
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PN 177196BB
QUALITY ASSURANCE INTERPRETING AND USING CELL CONTROL DATA
4.3
INTERPRETING AND USING CELL CONTROL DATA

A Objectives
When you have completed this topic, you will be able to: B Explain the statistics associated with the control files and graphs. B Review numeric and graphic control data for errors and make appropriate corrections. B Establish running means and expected ranges for parameters without assay values or for which you want to use your own values and ranges.
B References
1. 2. In the Online Help System or the Instructions for Use manual, refer to Reviewing Control
Results under Heading 7.3 RUNNING CELL CONTROLS.
Basic Concepts of Quality Control, PN 4235526
This material can be covered in front of the instrument, particularly if you are helping the trainee interpret their control data, but it can also be covered in a classroom setting.

1. 2. Interpreting cell control data can be divided into two activities: checking the results of one control run and checking the results of many control runs collected over time. When you are running controls before running patient samples, your first concern is to address why the results of the immediate run did not fall within the expected range. Refer to WHAT TO DO WHEN A CBC/DIFF CONTROL IS OUTSIDE ITS EXPECTED RANGES in this section. 3. As data in your control file accumulates, you can also: a. b. c. 4. Check for a change (shift or trend) developing over time, or for results spread too widely (increased 2 SD and CV). Use the data to refine your controls target values and ranges. Use the data to define a target value and ranges for any parameters without assigned assay values.
Graphing control data facilitates monitoring instrument performance and aids in troubleshooting. a. It allows you to easily view 1) 2) 3) b. c. Trends, shifts, and outliers. In control and out of control results. Subtle developing problems.
Different types of changes on the graphs suggest different sources for error. Refer to USE GRAPHS TO DETECT PROBLEMS AND POINT TO SOLUTIONS in this section.
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5.
When troubleshooting a problem with control results, keep the following factors in mind:
Affect on Results Generally affects only one parameter (and any associated parameters) on one vial of control. Generally affects only one level or vial of control. Concerns The frequency of outlier occurrences should be carefully monitored. A high frequency of outliers could indicate an underlying problem with the instrument, control material, or Operator technique. Any change in the control material can cause the control to be out. Controls must be handled carefully as instructed on the package insert. If control material is treated roughly, stored improperly, or used beyond the expiration date, results may be outside the limits. Any change to the instrument regarding the test system may cause controls to be out.
Problem Statistical Outlier
Control
Instrument
Generally affects more than one level or vial of control.
6.
The package insert for the COULTER ACT 5diff CONTROL PLUS states that your instrument is considered well maintained and operating correctly if before the current cell control lots expire, the laboratory does one of the following on the new lots of cell control: a. b. Confirms recovered mean values are within the assay limits. Establishes its own mean values and acceptable ranges and periodically re-evaluates those means.
7.
Performance specifications for your instrument are located under Heading 3.2 PERFORMANCE SPECIFICATIONS, in the Online Help System or the Instructions for Use manual. If the trainee needs more basic information on quality assurance, suggest Basic Concepts of Quality Control, PN 4235526, as a reference. a. b. Contact your Beckman Coulter Representative to order a printed copy. This book is designed for someone with little or no quality assurance experience. The following information and a self-evaluation is included: 1) 2) 3) 4) 5) 6) 7) 8) 9) Fundamental components of a quality assurance program Definitions of common terminology How to read a package insert Difference between a control and a calibrator Why calibration is necessary How to determine if a control is in or out What to do if a control is in What to do if a control is out Outliers
8.
10) Trends 11) Shifts 12) Interlaboratory Quality Assurance Program (IQAP) 13) A glossary 4-10
PN 177196BB
WHAT TO DO WHEN A CBC/DIFF CONTROL IS OUTSIDE ITS EXPECTED RANGES

1
Check for a control problem. a. Unless you have established your own running mean and/or expected ranges, ensure the values/expected ranges assigned on the Setup screen match the values on the controls package insert. If they do not, change the control setup information to match the package insert. The instrument recalculates the results based on the new values/ranges. b. Ensure the control material was properly mixed. If it was not: 1) 2) 3) Mix a new vial according to package direction. Run the new vial. If the control results are now in a) b) c) c. Delete the out of limit results and keep the new results. Enter a comment explaining your action in the Quality Control Log per your laboratorys protocol. Discard the incorrectly mixed vial of control.
If neither of the above apply, proceed to the next check. If the results are now in control, the out of limits result was probably a statistical outlier; keep both sets of data in the control file. If the rerun reflects the same parameters as still being out-of-control, proceed to the next check. Run another vial or another level of control, being careful to follow the instructions on the package insert for proper handling. If the control results are now in 1) 2) Delete the out of limit results and keep the new results. Discard the contaminated vial of control.
Rerun the control to determine if the out-of-limit result is a statistical outlier. a. b.
Ensure the control material was not contaminated. a. b.
c.
If the results are still out, proceed to the next step. Do the Extended Cleaning procedure under Heading 11.6 DIAGNOSTICS USER SCREEN, in the Online Help System or the Instructions for Use manual. Rerun the control. 1) If the results are acceptable: a) b) c) 2) Delete the out of limit results and keep the new results. Run other control levels that need to be processed. Resume normal operation. You are ready to analyze patient samples.
Clean and check the instrument. a. b.
If the results are still out, call your Beckman Coulter Representative to help you troubleshoot.
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USE GRAPHS TO DETECT PROBLEMS AND POINT TO SOLUTIONS

Trend r A trend is a gradual change in five or more consecutive results, all going upward or all going downward. r Systematic drift or trend in control values suggests that a problem is progressively developing. r Generally due to the deterioration of a reagent or control material.
Shift r A shift is a sudden or abrupt change in five or more consecutive results all above or all below the mean. r This type of systematic error may be associated with a change in instrument performance or a malfunction of the instrument.
Outlier r An outlier is a single result that falls outside the upper or lower limit. r Chance probability for a value to be outside the limit is about one time out of every 20 times control is run. r In this example, run #6 (from the right) is an outlier; notice the plot point is inside the upper double line. t With computerized graphing, small double-lined area typically serves as a limit for the plot point. t Since the plot point for an outlier cannot extend beyond this set boundary, the Operator must look at the numeric results to determine if the result is slightly outside the limit or greatly exceeds the limit. t If the numeric result for the outlier is only slightly beyond the limit, it may be a statistical outlier (control value is out by chance). r To confirm a statistical outlier, the Operator must run the control one more time. t If the result of the rerun is now in-control, the analytic run is accepted and both runs (the statistical outlier and the acceptable rerun) are to be included in the control data. t If rerun of control reflects the same parameters as still being out-of-control, there may be a control or system problem.
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PN 177196BB
QUALITY ASSURANCE CONTROL DATA MANAGEMENT
4.4
CONTROL DATA MANAGEMENT

A Objectives
When you have completed this topic, you will be able to: B Print control file data. B Exclude individual control runs. B Delete a control file.
B References
r Printing/Transmitting Saved Cell Control Results under Heading 7.3 RUNNING CELL CONTROLS. Heading 7.5 DELETING QC RUNS/FILES.
2.
Locate and make a copy of the CONTROL DATA MANAGEMENT SUMMARY.
1. 2. The instrument must be powered up. A control file with results from at least one sample is needed, but a control file with results accumulated for several days is better.

1. Control file management has to do with accessing control results in a control file and manipulating the data. Data manipulation can include: a. b. c. d. Deleting a sample from a control file. Deleting a control file. Printing or transmitting one or more results from a control file. Downloading control files to IQAP. Note: IQAP is covered under Heading 4.5, INTERLABORATORY QUALITY ASSURANCE (IQAP), in this section of the Training Guide. 2. Have the trainee locate the Printing/Transmitting Saved Cell Control Results procedure under Heading 7.3 RUNNING CELL CONTROLS in the Online Help System or the Instructions for Use manual, and print a control summary for one of the controls files in use on their instrument. Have the trainee locate Heading 7.5 DELETING QC RUNS/FILES, in the Online Help System or the Instructions for Use manual and, unless it is it is time for a control file to be deleted, just review the procedure with the trainee. Give the trainee a copy of the CONTROL DATA MANAGEMENT SUMMARY and review the file management procedures.
3.
4.
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QUALITY ASSURANCE INTERLABORATORY QUALITY ASSURANCE (IQAP)
4.5
INTERLABORATORY QUALITY ASSURANCE (IQAP)

A Objectives
When you have completed this topic, you will be able to: B Explain the purpose of the Interlaboratory Quality Assurance Program (IQAP).
B References
1. In the Online Help System or the Instructions for Use manual, refer to: r r 2.
IQAP ID (Entering/Editing) under Appendix A.5 QUALITY ASSURANCE SETUP. Heading 7.7 DOWNLOADING CELL CONTROL RESULTS FOR IQAP
IQAP manual, PN 4206266
The instrument needs to be powered up if you want to access the IQAP screens.

1. Coulter Interlaboratory Quality Assurance Program (IQAP) allows all regular users of ACT 5diff Control Plus cell controls to have their control data compared to control data from other laboratories using the same lot number on the same type of instrument. a. b. c. 2. Coulter Interlaboratory Quality Assurance Program (IQAP) is a service offered to all regular users of ACT 5diff Control Plus cell controls. IQAP complements a laboratorys in-house quality control program by providing peer group comparisons for your control results. The assessment is completely independent of assay values supplied with the control.
Two software screens are associated with IQAP: the screen for entering your IQAP ID number and the screen for downloading your IQAP data. a. To use the Quality Assurance Setup screen to enter or change an IQAP ID, refer to the procedure, IQAP ID (Entering/Editing), under Appendix A.5, in the Online Help System or the Instructions for Use manual. To use the IQAP screen to download control data, refer to Heading 7.7 DOWNLOADING CELL CONTROL RESULTS FOR IQAP, in the Online Help System or the Instructions for Use manual.
b.
3. 4.
The IQAP manual, PN 4206266, provides information on enrollment, data submission, interpreting the IQAP report, and troubleshooting IQAP problems. When using IQAP , it is recommended that you keep the submitted control data in its control file (as opposed to deleting it). If you need to collect data for the same lot number of control for another month, you can do one of two things. a. b. Continue using the same control file but deselect all the data you submitted for IQAP so that it is not included in the next months statistics. Set up a new control file with the same Sample ID. Enable Reserved for the new control file and disable Reserved for the old control file, so that control results are routed to the go into the new file.
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PN 177196BB
QUALITY ASSURANCE REPRODUCIBILITY AND CARRYOVER CHECKS
4.6
REPRODUCIBILITY AND CARRYOVER CHECKS

A Objectives
When you have completed this topic, you will be able to: B Explain the purpose of a reproducibility check. B Locate the procedure for running a reproducibility study in the Manual mode. B Locate the procedure for running a reproducibility study in the Automatic mode. B Explain the purpose of a carryover check.
B References
In the Online Help System or the Instructions for Use manual, refer to Heading 11.8
REPRODUCIBILITY CHECK.
1. 2. 3. The instrument must be powered up. If you plan to do either of these checks as part of the training, make sure you have the blood samples needed. An ideal time to teach the reproducibility check is right before a scheduled instrument calibration.

Reproducibility Check 1. The Reproducibility Check measures how close several results from the same specimen are to each other; in other words, this check measures repeatability or precision. a. b. Reproducibility does not measure accuracy, but true accuracy is not possible unless the instrument is precise. Doing a reproducibility check before doing a calibration could catch imprecision problems that might affect the calibration process. tt to access the Reproducibility screen. . The
2.
From the Main menu, click a. b.
To access the procedure when on the Reproducibility Check screen, click book is automatically opened to Heading 11.8 REPRODUCIBILITY CHECK. This section includes two procedures for checking reproducibility: one for the Manual mode and one for the Autoloader mode.
3.
Review the procedure for checking the reproducibility in the Autoloader mode with the trainee. Note: If Service is the trainer, a good time to review this procedure with the Key Operator is when you are doing it as part of the Installation procedure. a. b. The reproducibility check can be done using CBC or CBC/DIFF panel. For best results, a fresh, normal whole-blood specimen must be used.
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QUALITY ASSURANCE REPRODUCIBILITY AND CARRYOVER CHECKS
c. 4.
Three tubes of the same normal, fresh whole-blood specimen, each cycled at least seven times, are needed to meet the 20 sample requirement.
When using the software to do a reproducibility check, the instrument calculates the mean and CV for each parameter. a. CV or Coefficient of Variation is a percentage of deviation from the mean SD - 100 CV% = ------------Mean b. Results that exceed the limits appear against a red background.
5.
The instruments performance specifications for reproducibility are listed under

Heading 3.2, PERFORMANCE SPECIFICATIONS, in the Online Help System or the Instructions
for Use manual. Carryover Check 1. 2. Carryover is the interaction of the previous sample with the current sample. A high to low carryover check verifies the high results of one sample do not affect the low results of the next sample. a. b. This instrument does not have an automated procedure for checking carryover. The carryover check is done by analyzing a whole-blood specimen with high values followed by a whole-blood specimen with low values; each specimen is run consecutively in triplicate Carryover is calculated as follows: Low 1 Low 3 - 100 Carryover = ---------------------------------------High 3 Low 3
c.
3.
The instruments performance specifications for carryover are listed under Heading 3.7 PERFORMANCE SPECIFICATIONS, in the Online Help System or the Instructions for Use manual.
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PN 177196BB
QUALITY ASSURANCE SETTING UP XB/XM
4.7
SETTING UP XB/XM
A Objectives
When you have completed this topic, you will be able to: B Explain the purpose of XM analysis. B Explain why the use of RBC indices is so effective in the XM analysis. B Locate the procedures for Setting up the XB/XM Quality Assurance option.
B References
XB/XM Options (Enabling/Disabling), under Appendix A.5. Setting XB/XM Limits, under Appendix A.5.
Bull BS, and Elashodd RM, et al. A study of various estimators for the derivation of quality control procedures from patient erythrocyte indices. AM J Clin Path, 1974; 61(4): 473-481.
The instrument must be powered up.

Defining the XB/XM Quality Assurance Method 1. XM analysis is a quality assurance method that allows a laboratory to use their patients results to continuously monitor the performance of their automated hematology system and thus control the quality of their reported results by monitoring their patient results Since this quality assurance tool is based on patient results, The more patient samples processed per day, the more frequent the system monitoring. a. b. c. Proper monitoring is best accomplished if the laboratory runs more than 100 patient samples per day. Running less than 100 patient samples per day means the system is not checked frequently enough for XB/XM to be considered a viable form of quality assurance. If your laboratory processes less than 100 samples per day but you still like to consider using this form of control, checking with your regulatory agencies may help you make a final decision. The material must be stable. The material must be similar in content to the patient samples that will be analyzed. XM analysis meets these requirements: 1) 2) 4. Uses the patient samples as the material so the similarity requirement is met. Uses the RBC indices (MCV, MCH, MCHC) so the stability requirement is met.
2.
3.
Any method used for quality control must use a material that meets two requirements: a. b. c.
No additional cost to the laboratory because this method uses patient samples.
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4-17
5.
Concept of this analysis is based on XB Analysis developed by Dr. Brian Bull but is modified so you can elect to use additional parameters. a. The traditional three parameter analysis focuses on the stable RBC indices: MCV, MCH, and MCHC. 1) The MCV, MCH, and MCHC are very tightly controlled by the body because the red cells function best within a very narrow range of size and hemoglobin content. Are typically stable for an individual patient from day to day Are stable for a patient population over time. Note: Many hospitalized patients have been investigated and it has been found that in medium to large general hospitals there is no significant day-to-day or week-to-week variability in the mean of their indices. b. The nine parameter analysis includes WBC, RBC, HGB, HCT, RDW, PLT as well as the MCV, MCH, and MCHC. Parameters other than the RBC indices, such as the white blood cells and platelets that are included in the 9-parameter XM analysis, tend to have a wider physiological range than the RBC indices and are, therefore, not as predictable.
2) 3)
6.
To use the XB/XM option, you must: a. b. c. Enable the XB/XM, choosing the three or the nine parameter option. Establish XB/XM mean values and limits for the chosen parameters. Enter the established mean values and limits into the software.
Setting Up the Instrument for XB/XM Analysis 1. The XB/XM analysis option is enabled on the Quality Assurance setup options screen. a. The procedure for changing this is setting, XB/XM Options (Enabling/Disabling), is covered under Appendix A.5 in the Online Help System or the Instructions for Use manual. Click tt tt QA Settings tab to see the current setting.
b. c. 2.
Change the setting if desired by the laboratory.
Each laboratory must establish their own target values and limits. Suggestions for beginning are covered below under Establishing Target Values and Ranges for the XB/XM Analysis. The XB/XM analysis target values and ranges are entered on the Modify Values screen. a. b. Click tt tt tt Target tab to display the Modify Values screen.
3.
If this laboratory plans to use XB/XM, help the trainee find the procedure, Setting XB/XM Limits, under Appendix A.5 in the Online Help System or the Instructions for Use manual. 1) 2) If the laboratory already has target values and limits to enter, have them enter them now using this procedure. If the laboratory does not have the target values and limits yet, walk them through the procedure.
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4-18
4.
When using XB/XM, you can elect to have the instrument stop analyzing patient samples when a XB/XM Failed message (alarm) is generated. a. Selecting Auto-Stop for a XB/XM Failed message is covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide. Click tt tt General tab to see the current setting for this option.
b.
Establishing Target Values and Ranges for the XB/XM Analysis 1. 2. Once an XM/XB option is enabled, the laboratory must establish their own mean values (XB/XM limits). The XB/XM mean values should reflect the entire patient population of the laboratory: a. b. 3. Patient population of a general hospital usually includes samples from all patient age groups, disease states and many hematologically normal samples. A patient population that includes only one age group or only one disease state will yield different target values than a patient population that includes all groups. You may want to start with the following target values and the 5% limit range suggested by Dr. Brian Bull for his XB Analysis. r r r b. MCV = 89.5 MCH = 30.5 MCHC = 34.0
For the Three-Parameter XB/XM analysis (MCV, MCH, and MCHC): a.
To calculate the range, multiply the target value by the percentage variation. For example: 1) 2) If for MCV you use Dr. Bulls suggested mean of 89.5 and a 5% limit. XM mean value x percentage = value (89.5 x 0.05 = 4.5) You would enter the 89.5 as the mean value and 4.5 as the limit. The Workstation calculates the upper and lower limits and displays them as a whole number. In this case, the upper limit would be 94 and the lower limit, 85. The upper and lower limits are displayed in whole numbers.
3) c.
If you begin with Dr. Bulls values, your laboratory must then evaluate and adjust the values for your own patient population. 1) 2) Collect results from at least 250, but ideally 1000 blood samples to find your laboratorys XM mean values. Include all types of patients (oncology, presurgical, OB, dialysis, out patients, and so forth).
d. e.
As long as the patient population remains constant, the XM mean values of each index also remain constant. If the patient population changes, the mean of an index may also change and need to be reevaluated.
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QUALITY ASSURANCE INTERPRETING AND USING THE XB/XM DATA
4.
For the remaining six of the Nine-Parameter XM Analysis a. Your laboratory must evaluate the results of your population and decide what represents an acceptable mean value for each parameter to begin establishing the XM mean values for your patient population Due to the wide physiological range for the other six parameter, you may wish to use a higher percent limit than you use for the MCV, MCH, and MCHC parameters.
b.
4.8
INTERPRETING AND USING THE XB/XM DATA

A Objectives
When you have completed this topic, you will be able to: B State the minimum number of samples collected for an XB/XM batch. B Describe the three areas of the XM graph. B Define the terms mean values and limits as they apply to the XB/XM analysis. B Identify the problem parameter (or parameters) causing an XM batch to be out-of-control.
B References
In the Online Help System or the Instructions for Use manual, refer to Heading 7.6 XB
ANALYSIS.
1. 2. The instrument must be powered up. Data needs to be collected for at least one XB/XM batch if you want to refer to XB/XM data and graph displays.

Interpreting the XB/XM Data 1. When XB/XM option is turned on, the Workstation: a. Stores the results of patient samples (including repeat samples) as they are cycled. 1) It excludes a patient sample result from the XB/XM analysis if one of the parameters used in the analysis is: a) b) c) 2) a) b) c) d) Incomplete (....) Above the linear range (++++) Flagged with an SCL, MIC, or SCH Samples processed in the reproducibility mode Samples processed in the calibration mode Controls with reserved lot numbers Blank (background) samples
It excludes results from the XB/XM analysis for the following sample types:
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PN 177196BB
b.
Does an XB/XM analysis at regular intervals on sets (batches) of 20 patient results, determining the batch mean of each parameter. 1) 2) The calculation is done automatically. This batch mean is not a simple average value of the patients parameter results, but a type of weighted moving average that statistically allows the small batch of 20 patient samples to appear as if it were a larger set of about 100. If the batch means are inside the expected XB/XM limits, the batch is IN and the instrument is considered to be functioning properly. If a batch mean is outside the expected XB/XM limits, the batch is OUT and must be investigated.
c.
Compares each batch mean to its expected XB/XM mean value. 1) 2)
d. 2.
Displays the batch data in graphs and tables. tt to display the XB/XM screen.
From the Main Menu screen, click a.
The main XB/XM screen displays graphs of the XB/XM results, and is the software path to the XB/XM data in tables, the screen for reviewing and deleting data in a particular XB/XM batch, and the screen for entering/editing the target values and limits for the XB/XM analysis. Note the right side of the screen displays the XB/XM graphs for the parameters included in the analysis. 1) Each graph contains three areas. a) b) c) 2) a) b) 3) The central line represents the actual XM mean value for that parameter. A line above XM mean value (central line) represents the upper limit and a line below the XM mean value represents the lower limit boundaries The areas showing dashes are the out-of-limit areas. Each data point represents 20 samples. Up to 60 data points (batches) can be displayed and printed.
b.
The data points are displayed in reference to the XB/XM limits.
Graphs are good for identifying trends and shifts. and the right side of the screen displays the XB/XM data in tables. alternates the display between graphs and data tables.
c.
Click
Note: Clicking 1)
The table on the top of this screen displays the parameter means for up to 60 batches. a) b) c) The most recent batch is located at the bottom of this table. After the first 60 batches are completed, this option always displays the last 60 completed batches. After the 60th batch is completed, the table begins to rollover, deleting the oldest batch results to make space for the last completed batch results.
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4-21
d) e) f) g) 2)
This data can be used to identify affected parameters and to determine the direction and amount of the change. If batch means are below the acceptable limits they are displayed in yellow. If batch means are above the acceptable limits they are displayed in red. Individual samples can be deleted but not individual batches.
The statistics table on the bottom of this screen displays the means and coefficients of variations of each parameter for the last 60 batches. and the Batch Details screen is displayed.
d.
Click 1)
This screen displays the results of each sample in the batch (data point) that was selected either on the graph or the batch data table. a) b) If a parameter is below the acceptable limits it is displayed in yellow and flagged with an L. If a parameter is above the acceptable limits it is displayed in red and flagged with an H.
2) e.
You can delete up to five samples from the batch results. tt Target tab and the Modify Values screen for entering the XB/XM limits
Click appears.
The procedure for entering XB/XM values and limits is covered under Heading 4.7, SETTING UP XB/XM, in this Training Guide. 3. The procedure, Reviewing XB/XM Analysis Information, is under Heading 7.6 XB ANALYSIS, in the Online Help System or the Instructions for Use manual. This section includes directions for excluding samples from a batch.
Using the XB/XM Data If the XB/XM is out, refer to WHAT TO DO IF AN XB/XM BATCH IS OUT, on the next page.
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PN 177196BB
WHAT TO DO IF AN XB/XM BATCH IS OUT

1
Assess the situation. a. b. c. d. Review the XM graphs and XM batch means to identify the out-of-limit parameter and note the direction of the change (increased or decreased). The physiological range of some parameters, like WBCs and Plts, makes it difficult to assess if a problem really exists or the diversity of the values has cause the problem. Generally more than one parameter may show a change. It is also important to note any parameter that may still be inside the limit but shows a significant change. A change in the patient population. A change in the system: the instruments components, calibration, or reagents. Look for a change in the overall patient population. 1) 2) 3) b. 1) 2) c. One or more new patient types were added to the population. One or more patient types are no longer part of the population. Possible seasonal change of the patient population (hospitals or clinics in resort areas) Future XM batch results will also be outside the limits. New XM mean values based on the current population must be established and used.
Consider the two situations that can cause an out-of-limits batch: a. b.
Check for changes in the patient population. a.
If a change in the overall patient population is probable:
If a change in the overall patient population is not probable, is it possible the population appears to have changed because the batch of 20 patients does not truly represent the total population. (Remember that up to five samples can be deleted if necessary.) Look for: 1) 2) 3) A very abnormal patient specimen. A number of the same type of patient, such as dialysis patients, in the same batch instead of random sampling. Non-reportable results where a batch of results was biased by short samples or erroneous data accumulated before a reagent/instrument problem was identified and solved.
d.
If a change in the patient population is doubtful, all the results in the current XM batch are physiologically possible, and random sampling is verified, consider an instrument problem. Can be a gradual change caused by a calibration drift or a component going bad over time. Can be a sudden change caused by a component failure. After the instrument problem is corrected, the XB/XM results should come back within limits.
Check for an instrument problem if the XM batch results go out and stay out. a. b. c.
Call your Beckman Coulter Representative for assistance if necessary.
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PN 177196BB
5CALIBRATION 5
5.1 CALIBRATION OVERVIEW
A Objectives
When you have completed this topic, you will be able to: B Explain the purpose of calibration. B Explain when one needs to calibrate the instrument. B Explain when one needs to verify calibration.
B References
In the Online Help System or the Instructions for Use manual, refer to Heading 10.1 GENERAL.
None

1. Calibration is used to standardize the instrument by determining its deviation from known reference values and applying any necessary correction factors. a. b. Calibration is done to ensure accurate instrument measurements for WBC, RBC, Plt, Hct, and Hgb. The calibration material used must either be a substance that is traceable to reference methods for the preparation of the material or normal whole bloods assayed by reference methods. Beckman Coulter recommends using ACT 5diff Cal Calibrator, which is traceable to reference methods and materials, as an alternative to the whole-blood reference method of calibration. At installation, before you begin analyzing samples After a major analytical component, such as the sampling syringe or an aperture, is replaced. If your Beckman Coulter Representative suggests you calibrate. If, in the normal process of tracking data for an extended period of time, your laboratory makes a specific decision to recalibrate a given parameter. This data can include cell control files, XB/XM batch files, and IQAP reports.
c.
2.
Calibration needs to be done: a. b. c. d.
3. 4. 5.
Never use calibration to adjust for an instrument problem. Never adjust to a specific value based on an individual sample result. Calibration needs to be verified: a. b. c. As dictated by your laboratory procedures, local, or national regulations. When controls show evidence of unusual trends. When controls exceed the manufacturers defined acceptable limits.
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CALIBRATION PRELIMINARY CALIBRATION CHECKS/PROCEDURES
5.2
PRELIMINARY CALIBRATION CHECKS/PROCEDURES

A Objectives
When you have completed this topic, you will be able to: B Do the preliminary calibration checks and procedures.
B References
In the Online Help System or the Instructions for Use manual, refer to Heading 10.2
PRE-CALIBRATION CHECKS.
1. 2. The instrument must be powered up. If possible, do this topic when calibration is needed.

1. 2. The preliminary calibration checks and procedures are designed to ensure the instrument is clean and operating optimally. As a matter of precaution it is a good idea to thoroughly review the data stored in current control files, the XB/XM files, if applicable, and the IQAP data. a. b. 3. a. Make sure that none of the data points to an instrument problem as opposed to a calibration problem. Note any possible biases that might require a change in a calibration factor. Verify the ambient room temperature is typical for the laboratory and within the instruments operating range (16 to 34C; 61 to 93F). The temperature specifications are listed under Heading 3.1, INSTRUMENT SPECIFICATIONS, in the Online Help System or the Instructions for Use manual. b. c. d. Ensure all reagent levels are adequate for calibration. Ensure the waste container has sufficient space for waste collected during calibration. If the instrument is not routinely shut down with Rinse reagent for at least 30 minutes every 24 hours the instrument is in use, do the Extended Cleaning procedure to ensure the Analyzer, particularly the apertures and baths, are clean. Do a Startup procedure. Run a commercial cell control.
Before beginning the calibration procedure you should:
e. f. 4.
Have the trainee locate Heading 10.2, PRE-CALIBRATION CHECKS, in the Online Help System or the Instructions for Use manual, and have them do the checks if calibration is scheduled.
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CALIBRATION AUTO-CALIBRATION
5.3
AUTO-CALIBRATION
A Objectives
When you have completed this topic, you will be able to: B Calibrate the instrument using the Auto-Calibration procedure outlined in the Online Help System or the Instructions for Use manual. B Demonstrate how to access the Calibration Log.
B References
In the Online Help System or the Instructions for Use manual, refer to:
r r r Heading 10.1 GENERAL Heading 10.3 CALIBRATOR SETUP Heading 10.4 AUTO-CALIBRATION
1. 2. 3. 4. The instrument must be powered up. Either an Supervisor or Service must be logged in to access the Calibration screen. If possible, do this topic when calibration is needed. If doing the calibration: a. b. All the precalibration checks must have been completed. An in-date calibrator with assay values (either printed or on disk) must be available.

Calibration Procedure Note: In the following training format, the Calibration screen and important calibration considerations are reviewed first and then the trainee is asked to do the calibration procedure. If working one-on-one with a trainee, it might be equally effective to have the trainee do the procedure and you point out the screen elements and other important facts as you go. 1. Auto-calibration must be done with the Calibration screen open. a. b. Click tt to access the Calibration screen.
The calibrator information (lot number, assay values and so forth) is listed on the left side of the screen. 1) 2) The calibrator information is entered on the Calibration Setup screen. Click to display the Calibration Setup screen. Note that assay values can be entered manually or downloaded from a disk. Click to return to the Calibration screen.
3)
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c.
The right side of the Calibration screen displays the calibration data in tables. 1) 2) The upper table displays the results of the calibration runs. The lower table displays the calibration statistics.
d.
As you review the Calibration screen elements, ensure the trainee understands the following terms:
N= 1. Number of calibrator runs included in the statistics for the parameter 2. 3. next to a set of results in the accumulated results table indicates that set of results is included in the statistics. next to a set of results in the accumulated results table indicates that set of results is not included in the statistics; therefore, N may be less than the number of results displayed on the table.
Mean
1. Average of the calibrator runs 2. Calculation should include at least 5 runs, but cannot include more than 11 runs 3. The minimum runs required can be selected on the Quality Assurance setup options screen. The default setting is 5. 4. To view the current Minimum Runs for Automatic Calibration setting, from the Main Menu click tt tt QA Settings tab.
New Cal Factor
1. Calibration Factor needed to recover the calibrator Target Value 2. Calculated and displayed whether or not you need to change it
arg et Value Old Cal Factor New Cal Factor = T ---------------------------------------------------------------------------Calibrator Mean Value
Old Cal Factor 1. The current Calibration Factor in use by the Analyzer 2. Remains the current calibration factor until a new factor is saved % CV 1. Indicates the reproducibility of the calibrator run 2. Checked to ensure valid data is used as you are deciding whether or not to recalibrate 3. Compared to the preset calibration CV limits displayed on the Quality Assurance setup options screen 4. To view the current CV limits, from the Main Menu click tt QA Settings tab. Target Values 1. The assigned value for each parameter 2. Assigned value obtained from the calibrator package insert tt
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PN 177196BB
3.
For good results, the calibrator must be stored, mixed, and handled according to the instructins on the package insert provided with the calibrator material. If the laboratory plans to use the recommended COULTER ACT 5diff Cal Calibrator and the trainee has not used it before, review the instructions on the package insert.
4.
Calibration can be done in the Autoloader mode or the Manual mode. a. b. If the calibrator vial has a pierceable cap, you can run it in the Autoloader mode or you can run it closed-vial in the Manual mode. If the calibrator vial has a non-pierceable cap, you must run it open-vial in the Manual mode. Before aspirating a sample, make sure the calibrator is well mixed according to the instructions on the package insert. Always remix the calibrator between cycles. If the cap is non-pierceable: 1) Remove the cap from the calibrator vial before placing the vial in the tube holder. Note: Cycling a vial with the non-pierceable cap still on will damage the sampling probe, requiring its replacement. 2) 3) Carefully close the cap-pierce door to prevent spillage from the open vial. Clean the cap threads with a lint-free tissue each time the cap is removed to prevent contamination from flakes of dried calibrator.
5.
If running the calibrator in the Manual mode: a. b. c.
6.
Once the calibration run is completed, the instrument automatically does the necessary calculations and checks the results. a. It compares the CVs of all the directly measured parameters to preset calibration CV limits and highlights in red any results that are out of limits. b. It compares the new calibration factors to the old calibration factors and highlights in red any calibration factors with a greater than 20% difference between the two. The Operator can exclude results from the calibration calculations. 1) 2) 3) 4) b. c. Sample results should only be excluded if you can trace an Operator error to the unacceptable results. Excluding too many runs can cover up an instrument problem and bias calibration. The minimum results needed is based on the Minimum Runs for Automatic Calibration setting on the Quality Assurance setup options screen. Beckman Coulter recommends calibration factors based on a minimum of five acceptable results.
7.
Calibration is done on the results accumulated for the runs selected. a.
The Operator can elect to force calibration, that is to calibrate even if results are outside limits. The Operator can elect to calibrate one or more CBC parameters.
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8.
If Auto-Print for Calibration Results is selected on the System setup screens, the calibration results are automatically printed. To view/change the current Autoprint setting for calibration, from the Main Menu click tt tt Printer tab.
9.
Calibration results are not transmitted to the Host computer.
10. Have the trainee locate Heading 10.3, CALIBRATOR SETUP, in the Online Help System or the Instructions for Use manual. a. If calibration is scheduled, have the trainee do the Calibrator Setup and the Auto-Calibration procedure (it follows the Calibrator Setup procedure). Note: A Service trainer can assist the trainee with calibration but cannot do it. b. If calibration is not scheduled, walk the trainee through the two procedures.
Calibration Log 1. When you calibrate an instrument, the event is automatically entered in the Calibration Log. a. From the Main Menu screen, click 1) 2) 3) 4) b. c. tt to access the Calibration Log.
The most recent reagent changed is displayed on the top of the log screen. The log entry includes the date and time of the event, the name of the Operator logged in, the expiration date of the calibrator, and the event. The Calibration Log saves entries for up to five years. Prior entries to the log are deleted on a first in, first out basis as the capacity is exceeded.
To add comments (up to 50 alphanumeric characters) to an entry, click on the entry and then on the Add Comments button. You can also elect to have the system display a comments field automatically whenever you calibrate. 1) The Logs (comments) options are part of the setup options covered under Heading 3.1 MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide. To view the selection, from the Main Menu click tt tt General tab.
2) 2. a. b. c. d.
Other events automatically entered on the Calibration Log include: Target value is changed Calibration analysis is rejected Calibration is forced Analysis is started and the calibrator is expired.
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CALIBRATION MANUAL CALIBRATION
5.4
MANUAL CALIBRATION
A Objectives
When you have completed this topic, you will be able to: B Locate the Manual Calibration procedure in the Online Help System or the Instructions for Use manual. B Name a reason for doing a manual calibration. B Locate the software screen for manually entering calibration factors.
B References
Appendix C MANUAL CALIBRATION. Edit/Accept Calibration Factors in Others (Diagnostic Functions) under Heading 11.6 DIAGNOSTICS USER SCREEN.
1. 2. The instrument must be powered up. All Operators can view the calibration factors, but if you plan to change a calibration factor as part of covering this topic, either a Supervisor or Service must be logged in.

1. If your ACT 5diff AL system is being used as a backup instrument to another COULTER hematology analyzer, you may want to fine-tune the calibration of the ACT 5diff AL system to ensure its results match the main (reference) instrument in the laboratory. Have the trainee locate Appendix C, MANUAL CALIBRATION, in the Online Help System or the Instructions for Use manual and review it. a. Since this is a calibration procedure, the same concerns about having the instrument clean and performing optimally that applied to auto-calibration apply to manual calibration. If you are trying to match a reference instrument, your calibrator material will probably be whole bloods run/assayed on the reference instrument.
2.
b. 3.
Once you have the calculated new calibration factors for the parameters desired, you need to enter them into the system. a. From the Main Menu screen, click tt tt to display the users Others screen. The Calibration Factors are displayed in the fields on the right side of the screen. If either a Supervisor or Service is logged in, is active and new calibration factors can be entered into the Calibration Factors fields. Note: Users logged in as Operator can view the factors but cannot change them.
b.
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CALIBRATION MANUAL CALIBRATION
c.
The procedure for entering manual calibration factors, Edit/Accept Calibration Factors, is under Heading 11.6 DIAGNOSTICS USER SCREEN, Others (Diagnostic Functions), in the Online Help System or the Instructions for Use manual.
4.
The Operator should contact their Beckman Coulter Representative if there are questions.
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6SAMPLE ANALYSIS 6
6.1 SPECIMEN HANDLING
A Objectives
When you have completed this topic, you will be able to: B Locate the approved tube list. B State the recommended anticoagulant to use for specimens processed on an ACT 5diff AL hematology analyzer. B State the minimum volume of blood needed for processing a specimen. B State the maximum storage time allowed prior to analyzing samples in the CBC versus the CBC/DIFF test panel. B State the correct storage temperature for whole blood stability.
B References
1. 2. Refer to the Hematology Tube list available on the BCI website at www.beckmancoulter.com. In the Online Help System or the Instructions for Use manual, refer to: r 3.
Recommended Anticoagulant and Sample Stability under Heading 3.1 INSTRUMENT SPECIFICATIONS.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the TUBE HOLDERS QUICK REFERENCE page.
For this topic the trainee must access the approved tube list.

1. 2. A wide variety of specimen tubes, micro-collection devices, and control vials are approved for use on the ACT 5diff AL hematology analyzer. Help the trainee locate the approved tube list. a. b. The tubes in the lists are known to be compatible with the cap-pierce mechanism. Being on the approved list is not a recommendation for using one tube in preference to another, nor does it guarantee the acceptability of the specimen tube to produce quality results. Have the trainee check the tube list for the Manual mode to determine which tube holders and positions to use for the tubes/micro-collection devices used in their laboratory. Give the trainee a copy of the TUBE HOLDERS QUICK REFERENCE.
c.
d.
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SAMPLE ANALYSIS SPECIMEN HANDLING
3.
The type of cap (pierceable or not) on the specimen tube/micro-collection device dictates whether a sample can be run closed-vial or must be run open-vial. a. Closed-vial sampling is recommended for evacuated collection tubes and control vials with pierceable stoppers or caps. 1) 2) b. Samples can be run in either the Autoloader or the Manual mode. Closed-vial sampling decreases the operators exposure to the whole-blood specimen which is considered a biohazardous material.
Open-vial sampling is required for evacuated collection tubes, micro-collection devices, and calibrator vials without pierceable stoppers or caps. 1) 2) 3) Samples must be run in the Manual mode. The stopper or cap must be removed prior to sampling. Open-vial sampling increases the operators exposure to the whole-blood specimen which is considered a biohazardous material.
4.
The size of the specimen tube/micro-collection device dictates whether a sample can be run in the Autoloader mode or must be run in the Manual-mode. Note that micro containers are only approved for the Manual mode. When collecting blood specimens in evacuated tubes: a. Collect venous blood specimens in K3EDTA or K2EDTA. 1) 2) 3) b. A correct proportion of whole blood to anticoagulant is critical. Collect venous blood according to the tube manufacturers requirements. K3EDTA is the preferred anticoagulant.
5.
At collection and before analysis, mix each blood specimen gently and thoroughly according to the tube manufacturers recommendations and your laboratorys protocol. Correct collection is critical to avoid micro-clots or debris. Review and follow the collection and mixing instructions in the package insert provided by the manufacturer. Make sure the manufacturers minimum fill volume is achieved. Anticoagulated capillary specimens collected in a micro-collection device can be aspirated as an open-vial specimen.
6.
When collecting blood specimens in micro-collection devices: a. b. c. d.
7.
To ensure that a full sample of whole blood can be drawn into the sampling probe, the minimum volume of blood that must be in the collection device is: a. b. 1 mL for collection devices having a fill volume >1 mL Three-quarters of the fill volume for collection devices having a fill volume 1 mL. 48 hours after collection for CBC parameters. 24 hours after collection for DIFF parameters.
8.
Specimens stored at room temperature can be analyzed for up to: a. b.
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SAMPLE ANALYSIS SAMPLE IDENTIFICATION
6.2
SAMPLE IDENTIFICATION
A Objectives
When you have completed this topic, you will be able to: B State three options for entering/assigning a Sample ID in the Manual mode. B State four options for entering/assigning a Sample ID in the Autoloader mode. B Explain the auto-numbering feature and state when it is used.
B References
In the Online Help System or the Instructions for Use manual, refer to: r r r
r Sample Identification under Heading 3.1 INSTRUMENT SPECIFICATIONS. Sample ID (Entering/Selecting) under Heading 8.7 ENTERING SAMPLE/PATIENT INFORMATION. Auto-Numbering (Setting the AUTO_SID Starting Number) under Heading A.4 OPERATIONAL SETUP. Heading 5.6 WORKING WITH BARCODE LABELS (if the laboratory plans to use bar-code labels).
1. 2. The instrument must be powered up. Either a Supervisor or Service must be logged in to view Setup options, but this is optional and is not required for covering the essential information in this topic.

Assigning Sample IDs 1. 2. A Sample ID is required to process a sample on the ACT 5diff AL hematology analyzer. Sample IDs can be assigned to a sample in one of five ways; it can be: a. b. c. d. e. 3. Entered manually. Scanned in by a hand-held barcode reader (optional). Downloaded by a Host computer. Read by an internal bar-code reader (Autoloader mode only). Assigned automatically by the instrument (Autoloader mode only).
In the Manual (STAT) mode, the operator can enter a Sample ID on the Manual Mode screen in one of three ways: a. b. c. Manually type it in. Scan in the barcode on the specimen tube label with the optional Barcode Scanner. Use the search function on the Manual Mode screen to search for the Sample ID on the Worklist if it has already been entered.
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6-3
4.
In the Manual mode a Sample ID must be assigned before you can initiate the cycle. a. b. You can enter a Sample ID in the Sample ID field on the Manual Mode screen. You can leave the Sample ID field blank and let the instrument assign an AUTO_SID. In either case, as soon as you click specimen tube with that Sample ID. the instrument prompts you to enter the
c. d.
An easy way to demonstrate the fact that you must have a Sample ID to initiate the Manual Mode cycle is as follows: 1) Click to select the Manual mode. The tube holder door opens and the Manual Mode screen is displayed. a) b) 2) Try to close the tube holder door to the sampling position to initiate the cycle. Note that you can close the door to the closed position but not to the sampling position. Place the cursor in the Sample ID field. Type in the Sample ID (up to 16 alphanumeric characters). Click . to accept the entry.
Manually enter a Sample ID: a) b) c)
3)
Click a) a)
The tube holder door opens and a message is displayed prompting you to insert the tube into the holder. At this point you could close the door to the sampling position and initiate a Manual mode cycle. to delete your request.
4) 5. a.
Since this is only a demonstration, click
In the Autoloader mode, the Operator can enter a Sample ID in one of five ways: Manually type it onto a Worklist. Note: A worklist is a list of samples with preassigned identification and demographic information that are pending analysis. Details about using the Worklist are covered later, under Heading 6.4, WORKFLOW OPTIONS. b. c. d. e. Scan in the barcode on the specimen tube label into a Worklist with the optional Barcode Scanner. Set up a Host Computer to download the Sample ID (and other specimen information) onto a Worklist. Let the instrument read a bar-code label on the specimen tube (using the internal bar-code reader) and assign the Sample ID to the sample. Let the instrument read the bar-code label on the front of the cassette (using the internal bar-code reader), determine the position of the specimen tube within the cassette, and assign an auto-numbered Sample ID to the sample.
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6.
In the Autoloader mode, because you have an internal bar-code reader to identify the sample (if it has a barcode label) and the cassette, you can initiate a cycle without entering a Sample ID. If a Sample ID is not preassigned to a sample via a Worklist, or if the instrument cannot find or read the bar-code label on the specimen tube, the instrument automatically assigns an auto-numbered Sample ID to that specimen. a. b. c. d. The auto-numbered Sample ID is preceded by AUTO_SID; for example, an auto-numbered Sample ID of 101 appears as AUTO_SID101. The AUTO_SID automatically increments by 1 from the previously assigned number each time a sample without a Sample ID is analyzed. Auto-numbering is always on and cannot be disabled. You can, however, set the starting number where auto-numbering begins. 1) Setting the initial auto-number is covered under Heading 3.1, MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS, in this Training Guide. The procedure for changing this setting, Auto-Numbering (Setting the AUTO_SID Starting Number), is under Heading A.4 OPERATIONAL SETUP , in the Online Help System or the Instructions for Use manual. To view the current setting entered, from the Main Menu click General tab. tt tt
7.
2)
3) 4) 5)
For auto-numbering to restart on this initial number, the Worklist from the previous Workday must be erased. If you reset this number, the new number becomes effective when Reset Autonumbering is selected on the Login screen at the beginning of a New Workday.
e.
Only the instrument can assign an AUTO_SID number. The Workstation will not accept a Sample ID entered by the Operator or downloaded from a Host computer with an AUTO_SID prefix.
8. 9.
A Sample ID can only appear once on the Worklist. After a Sample ID is entered on the Worklist it can be deleted but it cannot be edited.
10. The instrument uses Sample IDs to distinguish between control sample results and patient sample results. a. b. c. When a control file is set up its lot number is reserved as its Sample ID. Since the software knows which Sample IDs are controls, it can post the results of a sample with a controls Sample ID in the appropriate control file. Therefore it is not necessary to run either a control sample or a patient sample with a particular screen open.
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SAMPLE ANALYSIS PATIENT/SAMPLE INFORMATION
Using Bar-Code Labels for Identification 1. If the laboratory plans to use barcode labels to identify specimen tubes: a. b. 2. Help the trainee find Heading 5.6 WORKING WITH BARCODE LABELS, in the Online Help System or the Instructions for Use manual. The placement and conditions of the barcode labels on a specimen tube are critical for a good reading. Review the information under Placing Labels on Tubes.
If the laboratory also plans to use the optional hand-held barcode reader to scan in the barcode labels on specimen tubes and control vials: a. Review Scanning Barcode Labels with the Optional Barcode Wand, under Heading 5.6 WORKING WITH BARCODE LABELS, in the Online Help System or the Instructions for Use manual. 1) 2) 3) 4) b. Risk of sample misidentification if the entire barcode is not captured with the barcode reader, especially with the interleaved 2-of-5 bar-code format. Position the reader over the entire barcode to capture the entire Sample ID. A beep indicates the barcode was read successfully. Verify each bar-code reading is correct to ensure correct sample identification.
The installation procedure for the Barcode Scanner and the specifications for setting it up to read your laboratorys barcode labels are in Appendix B, BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND, of the Online Help System or the Instructions for Use manual. The Barcode Scanner is installed and set up by your Beckman Coulter Representative.
c.
6.3
PATIENT/SAMPLE INFORMATION
A Objectives
When you have completed this topic, you will be able to: B State the three pieces of sample information required for every sample processed. B Display two screens where the required sample information can be entered. B Explain the purpose of a flagging set. B Contrast patient ranges and action ranges and explain the flagging for each. B Cite the flagging set that would be applied to the patient results for different scenarios presented by the trainer.
B References
r Flagging Sets under Heading 3.1 INSTRUMENT SPECIFICATIONS. Panel (Selecting CBC or CBC/DIFF) under Heading 8.7 ENTERING SAMPLE/PATIENT INFORMATION. Default Panel (Selecting CBC or CBC/DIFF) under Heading A.4 OPERATIONAL SETUP. Heading 5.15 UNDERSTANDING HOW FLAGGING SETS ARE APPLIED. Flagging Set (Selecting) under Heading 8.7 ENTERING SAMPLE/PATIENT INFORMATION.
r r
r
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r r
Heading A.10 FLAGGING SETS SETUP. Heading 8.8 UNDERSTANDING THE WORKLIST SCREENS

Required Patient/Sample Information 1. Three pieces of information must be associated with every sample processed on the ACT 5diff Autoloader hematology analyzer: a. b. c. 2. a. The Sample ID. This is covered under Heading 6.2, SAMPLE IDENTIFICATION, in this section of the Training Guide. The test panel needed. The flagging set to use. If the CBC panel is selected, typically 10 parameters are reported. 1) 2) b. WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, and MPV If RUO (Research Use Only) parameters are enabled, Pct and PDW are also reported. CBC parameters: WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV DIFF parameters: NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA# If RUO (Research Use Only) parameters are enabled, Pct, PDW, IMM%, IMM#, ATL%, and ATL# are also reported.
Two test panels, CBC or CBC/DIFF , are available.
If the CBC/DIFF panel is selected, typically 20 parameters are reported. 1) 2) 3)
3.
The test panel can be preselected for a specific specimen on the Worklist screen. a. b. Click to display the Worklist screen. alternates the test panel
When making entries on this screen, clicking between CBC and CBC/DIFF.
Note: If your laboratory plans to use a Worklist you will have the opportunity to make entries on this screen when you setup and analyze samples. c. 4. Click to exit the Worklist screen.
The test panel can also be preselected for a specific specimen on the Manual Mode screen. a. Click to display the Manual Mode screen.
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6-7
b.
When making entries on this screen, clicking between CBC and CBC/DIFF. Click to exit the Manual Mode screen.
alternates the test panel
c. 5. a.
If a test panel is not preselected for a sample, the instrument uses the default setting. The procedure for changing this setting, Default Panel (Selecting CBC or CBC/DIFF), is , in the Online Help System or the Instructions under Heading A.4 OPERATIONAL SETUP for Use manual. To view the default setting, from the Main menu, click tt tt General.
b. 6. a. b.
A flagging set is a set of patient and action limits defined for a specific group of patients. The instrument comes with 8 predefined flagging sets and the capacity for the laboratory to add 12 more. The predefined flagging sets are based on age and gender as follows:
.
FLAGGING SET NAME Standard Range Man Woman Child 1 Child 2 Child 3 Child 4 Child 5
GENDER
AGE RANGE
LIMITS EDITABLE
Not defined Male Female Not defined Not defined Not defined Not defined Not defined
Not defined > 14 years > 14 years Editable Editable Editable Editable Editable
No Yes Yes Yes Yes Yes Yes Yes
c.
Patient and action limits can be edited for all flagging sets except Standard Range. 1) Typically the laboratory: a) b) 2) Sets patient limits to flag a parameter that has exceeded the normal range established for the patients sex or age. Sets action limits to flag a parameter that has exceeded limits established by the laboratory as requiring further action to verify the results.
Defining the flagging sets is covered in detail in Heading 3.7, FLAGGING SETS SETUP OPTIONS, in this Training Guide. The flags for parameters outside the patient limits of a flagging are: a) b) c) L-flag appears to the right of the result that is below the lower limit. H flag appears to the right of the result that is above the upper limit. A yellow background accompanies the flag. LL flag appears to the right of the result that is below the lower limit.
d.
If a parameter result is outside the designated range, the result is flagged. 1)
2)
The flags for parameters outside the action limits of a flagging set are: a)
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PN 177196BB
b) c) d) e.
HH flag appears to the right of the result that is above the upper limit. A red background accompanies the flag. May also generate an interpretive message
Flagging set limits can also be used as a criteria for the instrument to do an automatic rerun. This will be discussed further under Heading 6.8, AUTOMATIC AND MANUAL SPECIMEN RERUNS, in this section of the Training Guide.
7.
The flagging set can be preselected for a specific specimen on the Worklist screen. a. b. Click to display the Worklist screen.
When making entries on this screen, you can select the flagging set from the Flagging Set drop-down menu. Note: If your laboratory plans to use a Worklist you will have the opportunity to make entries on this screen later in this section when you set up and run samples.
c. 8.
Click
to exit the Worklist screen.
The flagging set can also be preselected for a specific specimen on the Manual Mode screen. a. b. Click to display the Manual Mode screen. When making entries on this screen, you can select the flagging set from the Flagging Set drop-down menu. Click to exit the Manual Mode screen.
c. 9.
If a flagging set is not preselected for a sample and a Worklist is used, the instrument selects the appropriate flagging set based on the age (or date of birth) and sex information entered on the Worklist. a. How the flagging set is selected is covered under Heading 5.15 UNDERSTANDING HOW FLAGGING SETS ARE APPLIED, in the Online Help System or the Instructions for Use manual. b. If the laboratory plans to use a worklist to add demographic information, make sure the trainee understands how the flagging set is determined by the software.
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FLAGGING SET HIERARCHY

Start
No
Current Flagging set= Default Flagging Set?
Yes
No
Current Flagging set based on Age or Gender ?
Yes
No
Age 14yr ?
Yes
No
Gender available ?
Yes Select child range
Flagging set remains as selected
Man
Woman
5
7367518B
10. If a flagging set is not selected for a sample and either a Worklist is not used or a Worklist is used but the patients age (or date of birth) and sex were not entered on it, the instrument uses the Default Flagging Set as shown above. a. The procedure for changing this setting, Setting a Default Flagging Set, is under Heading A.10 FLAGGING SETS SETUP , in the Online Help System or the Instructions for Use manual. To view the default setting, from the Main menu click tt .
b.
Optional Patient/Sample Information (Entered via a Worklist) 1. If a Worklist is used, additional information can be associated with a sample. a. b. A Worklist contains sample and patient identification information for specimens that are pending analysis. Before the sample is analyzed, you can enter or edit patient demographics on the Worklist.
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1) 2) c.
Demographics include patient name, age, date of birth, gender, clinic location, physician, and comments. The demographics are saved with the sample and printed or transmitted as part of the full patient report.
If the Host transmission protocol is established, demographics are automatically downloaded from the Host computer. You cannot edit information downloaded from the Host computer. to display the Worklist screen.
2.
Click a. b.
The fields on the right of the screen allow you to enter sample/patient information. The optional information that can be entered includes: 1) 2) 3) 4) Collect Date/Time Location Select from the drop-down menu or type it in. Physician Select from the drop-down menu or type it in. Comments allows you to enter sample comments; comments (up to 50 alphanumeric characters). 5) Patient ID If you enter demographic information and do not enter a Patient ID, the system automatically assigns a Patient ID when the order is saved on the Worklist. 6) Last Name If the patients demographics are already in the system, you can search on the last name to find and display the rest of the information. 7) 8) 9) First Name Date of Birth Used to calculate age for the Age field. Can be used to determine flagging set. Age If a date of birth was entered, the patients age is automatically entered. When entering manually, enter Y for years, M for months, W for weeks, D for days. Can be used to determine flagging set. 10) Gender Select from the drop-down menu. Can be used to determine flagging set. allows you to enter patient
c.
Click
to exit the Worklist screen.
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SAMPLE ANALYSIS WORKFLOW OPTIONS
6.4
WORKFLOW OPTIONS
A Objectives
When you have completed this topic, you will be able to: B State the preferred method for identifying a sample in the Autoloader mode. B Define a Worklist and state two reasons why your laboratory may want to use one. B Explain the reason for using the Manual Match option with a Worklist.
B References
r Heading 2.8 WORKFLOW AND WORKLISTS. Worklist Match and Manual Match Options under Heading A.4 OPERATIONAL SETUP .
The instrument must be powered up and either a Supervisor or Service must be logged in to view Setup options, but this is optional and is not required for covering the essential information in this topic.

1. 2. Work flow is the sequence of tasks used to analyze samples and generate patient reports. Work-flow patterns on the ACT 5diff AL hematology analyzer evolve around two factors. Does the laboratory plan to use: a. b. 3. Barcode labels on the specimen tubes for identification. A Worklist to enter the work order and other information for the specimen.
Using the internal bar-code reader, the instrument can use one of two methods to identify each sample as it is processed in the Autoloader mode. a. It can read a bar-code label on the specimen tube, identifying the sample by the Sample ID encoded in the label. 1) 2) 3) b. This is the recommended method of sample identification. The identification is attached directly to the specimen tube. This is the easiest method to use because the Operator can load the specimen tubes into the cassette in any order.
It can read the bar-code label on the cassette, identifying the sample by the cassette number and its position in the cassette. 1) 2) This is not the recommended method of sample identification. This method relies on the Operators accuracy in placing the specimen tubes in their correct cassette positions to match results to the correct specimen. Note: If you use this method and the specimen tube has a bar-code label, the label is still read. It is just not used as the primary ID.
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SAMPLE ANALYSIS WORKFLOW OPTIONS
4.
The laboratory chooses which positive ID, Barcode or Cass./Position, to use and the instrument is set up for that at installation. a. b. The default setting is Barcode. The procedure for selecting the positive ID, Worklist Match and Manual Match Options, is , in the Online Help System or the Instructions under Heading A.4 OPERATIONAL SETUP for Use manual. To view the positive ID setting, from the Main menu click tt tt General.
c. 5. a.
A Worklist is a list of work to be done on the instrument. A Worklist provides two functions that may be important to your laboratory. 1) It provides a way to enter patient demographics, such as patient ID, name, gender, date of birth, age, physicians name, clinic location, and comments, so that this information can be linked with the final results. It allows you to choose the test panel and flagging set for each specimen.
2) b. c. d. 6.
Host transmission protocol can be established so that demographics are automatically downloaded from the Host computer to the Worklist. Identifiers and demographic information must be entered before running the patient specimen. After the specimen is processed, all entered information is printed on the final report, stored in the archive, and transmitted to a host computer, if applicable. If the instrument cannot read the barcode on a tube, or if the instrument cannot find a Sample ID for results on the Worklist, it cannot match (link) the information. A Manual Match option allows the Operator to make the match when the instrument cannot. 1) 2) 3) If the Manual Match option is ON, the unmatched results are placed on the Match screen instead of the Results List screen. If the Manual Match option is OFF , the results are reported as analyzed.
The positive ID is the link between the sample results and information on the Worklist. a. b.
7.
The Manual Match option is covered under Heading 6.9, MANUAL MATCHES, in this section of the Training guide. If using a Worklist, this is the workflow scenario: a. b. c. d. e. f. g. h. An order is placed on the Worklist (by manual entry or by Host download). The order appears on the Worklist. The sample is analyzed for that order in the Autoloader mode or the Manual mode. The sample results are matched to the information on the Worklist and posted to the Results List screen for verification. If the results cannot be matched and the Manual Match option is ON, the results are posted to the Match screen for Operator intervention. The order is removed from the Worklist once results are matched to a Sample ID. The results are archived at the start of a New Workday or when the Operator chooses to move them from the Results List screen to the archives. Archived results can be located by Patient ID or run date. Searching for archived results is coverd under Heading 7.1, DATA MANAGEMENT, in this Training Guide. 6-13
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SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE AUTOLOADER MODE
6.5
SAMPLE ANALYSIS IN THE AUTOLOADER MODE

A Objectives
When you have completed this topic, you will be able to: B Demonstrate the correct way to load and unload cassettes with specimen tubes, and load and unload the Autoloader with cassettes. B State why using barcode labels and a Worklist is the preferred method of analysis. B Run patient samples using your laboratorys selected method.
B References
1. In the Online Help System or the Instructions for Use manual, refer to: r r r 2.
Heading 5.7 WORKING WITH THE CASSETTES Heading 8.5 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE. Heading 8.8 UNDERSTANDING THE WORKLIST SCREENS
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the appropriate summary page. Four are available: r r r r
SAMPLE ANALYSIS IN AL MODE: BARCODE POSITIVE ID WITH WORKLIST SUMMARY SAMPLE ANALYSIS IN AL MODE: BARCODE POSITIVE ID WITHOUT WORKLIST SUMMARY SAMPLE ANALYSIS IN AL MODE: CASS/POS POSITIVE ID WITH WORKLIST SUMMARY SAMPLE ANALYSIS IN AL MODE: CASS/POS POSITIVE ID WITHOUT WORKLIST SUMMARY.
1. 2. The instrument must be ready to analyze patient samples. If necessary, do a Startup procedure or a Mini-Clean cycle and analyze controls to ensure the instrument is ready. You will need at least ten whole blood specimens collected in the specimen tubes with pierceable tops that will be used by the laboratory, barcode labeled if applicable.

1. In the Autoloader mode, up to 100 closed-vial specimens can be loaded into the instrument for analysis at a time. a. b. Specimen tubes are loaded into cassettes (up to 10 per cassette) and the cassettes are loaded onto the cassette input tray for processing (up to 10 cassettes at a time). If necessary, review/demonstrate the correct technique for loading specimen tubes into a cassette, loading the cassette onto the cassette input tray, unloading the cassette from the cassette output tray, and unloading the tubes from the cassette. Note: Emphasize that cassettes must be unloaded and never used as storage racks.
2.
This information is covered under Heading 5.7 WORKING WITH THE CASSETTES, in the Online Help System or the Instructions for Use manual. Four methods for analyzing patient samples in the Autoloader mode are covered under Heading 8.5 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE, in the Online Help System or the Instructions for Use manual.
c.
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SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE AUTOLOADER MODE
a.
Worklist: Barcode Positive ID, Manual Match ON 1) 2) This is the preferred method as it provides the strongest and most reliable link between the sample results and the specimen. The specimen is identified by a label attached directly to it, the work order is entered using the identification from that label, the instrument reads that label when it analyzes the sample, and then the instrument matches the sample results with the information entered for the specimen with that label. Using the Manual Match option allows the Operator to intervene when the instrument cannot match the results with an order on the Worklist.
3) b. c. d.
No Worklist: Barcode Positive ID, Manual Match OFF Worklist: Cass./Position Positive ID, Manual Match ON No Worklist: Cass./Position Positive ID, Manual Match OFF 1) 2) 3) This method is not recommended as it provides the weakest link between the sample results and the specimen. The positive link betweeen the auto-numbered sample results and the specimen tube is the position of the specimen tube in a specific cassette. As soon as the Operator unloads the cassettes, that link is broken.
3.
Determine which method the laboratory plans to use. a. If the laboratory plans to use a Worklist, you may want to review the Worklist screen now or wait and do it as the trainee makes entries on the Worklist. 1) The two Worklist screens, Worklist Grid and Worklist Cassette, are described under Heading 8.8 UNDERSTANDING THE WORKLIST SCREENS, in the Online Help System or the Instructions for Use manual. The Worklist Grid screen is the screen you see when you click .
2) 3)
The Worklist Cassette screen is available from the the Worklist Grid screen when Cass./Position is used as the positive identifier.
b.
Help the trainee find the appropriate procedure for running samples under Heading 8.5 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE, in the Online Help System or the Instructions for Use manual, and use it to setup and analyze 10 whole-blood specimens.
4.
As samples are analyzed, you may want to review results on the Run-in-Progress screen. a. b. From the Main Menu screen, click 1) 2) c. to display the Run-in-Progress screen.
The Run-in-Progress screen displays results of the last sample ran. Fields on the left side display information about the sample. Fields on the right side display the results: numeric data, histograms, and flags.
The Run-in-Progress screen is covered under Heading 6.7, RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS, in this section of the Training Guide.
5.
Give the trainee a copy of the appropriate summary page to use for analyzing samples in the Autoloader mode and review the procedure as needed. 6-15
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SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE MANUAL MODE
6.6
SAMPLE ANALYSIS IN THE MANUAL MODE

A Objectives
When you have completed this topic, you will be able to: B State three circumstances under which you would use the Manual mode for processing a sample instead of the Autoloader mode. B Demonstrate the correct way to interchange tube holders. B Demonstrate the correct way to insert a tube into the tube holder and close the tube-holder door. B Run patient samples in the Manual mode using your laboratorys selected method.
B References
r Heading 5.8 WORKING WITH THE TUBE HOLDER Heading 8.4 RUNNING MANUAL (STAT) SAMPLES.
2.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the SAMPLE ANALYSIS IN MANUAL MODE SUMMARY.
1. 2. The instrument must be ready to analyze patient samples. If necessary, do a Startup procedure or a Mini-Clean cycle and analyze controls to ensure the instrument is ready. You will need several specimens collected in the specimen tubes typically used by the laboratory. If micro collection devices are used, it would be a good idea to include a few of those as well.

1. The Manual mode is also referred to as the STAT mode as you can use it to interrupt an Autoloader run and analyze a STAT sample. a. If you are processing a cassette in the Autoloader mode, when you click to initiate the Manual mode the instrument completes the cycle in process and moves the cassette out of the piercing area. After the STAT sample is processed in the Manual mode, flashes, indicating the instrument is ready to resume operating in the Autoloader mode. In small micro-collection devices. Refer to the Hematology Tube List available on the BCI website at www.beckmancoulter.com, to review the collection devices that can be used. In vials with non-pierceable caps that must be analyzed in the open-vial mode.
b. 2.
The Manual mode offers the versatility of being able to analyze samples: a.
b. 3.
In the Manual mode, only one specimen tube at a time can be loaded into the instrument for analysis.
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SAMPLE ANALYSIS SAMPLE ANALYSIS IN THE MANUAL MODE
a.
After a Sample ID is entered for the specimen tube, the specimen tube is loaded into the correct tube holder for the specimen tube or micro collection device and the tube holder is placed into the correct position for sampling. If necessary, review/demonstrate the correct technique for loading a specimen tube into the tube holder and positioning the tube holder for sampling. This information is covered under Heading 5.8 WORKING WITH THE TUBE HOLDER, in the Online Help System or the Instructions for Use manual. If more than one STAT specimen comes in at the same time, you must follow the same procedure successively for each specimen.
b. c. d. 4.
Two methods for analyzing patient samples in the Manual mode are covered under Heading 8.4 RUNNING MANUAL (STAT) SAMPLES, in the Online Help System or the Instructions for Use manual.
a.
If the laboratory plans to use a Worklist, help the trainee find and use both the procedures. 1)
2) Procedure for Running Manual (Stat) Samples: Order On Worklist or Not Using Worklist. Procedure for Running Manual (Stat) Samples: No Order on Worklist and You Want to Assign Demographics.
b. c. 5.
If the laboratory does not plan to use a Worklist, help the trainee find and use the Procedure for Running Manual (Stat) Samples: Order On Worklist or Not Using Worklist. If the laboratory uses both specimen tubes and micro-collection devices, make sure they know how to run both in the Manual mode.
As a sample is analyzed, you may want to review results on the Run-in-Progress screen. a. b. From the Main Menu screen, click 1) 2) c. to display the Run-in-Progress screen.
The Run-in-Progress screen displays the results of the last sample ran. Fields on the left side display information about the sample. Fields on the right side display the results: numeric data, histograms, and flags.
The Run-in-Progress screen is covered under Heading 6.7, RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS, in this section of the Training Guide.
6.
Give the trainee a copy of the SAMPLE ANALYSIS IN MANUAL MODE SUMMARY, reviewing the procedures as necessary and noting that: a. b. c. Both procedures in the Instructions for Use manual are on the same summary page. The Procedure for Running Manual (Stat) Samples: Order On Worklist or Not Using Worklist has been divided into two procedures. The only real difference between the procedures is how the Sample ID is entered.
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6-17
SAMPLE ANALYSIS RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS
6.7
RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS

A Objectives
When you have completed this topic, you will be able to: B Display both a Run-in-Progress screen and a Results screen. B State the types of information found on both the Run-in-Progress and Results screens. B State four features that are available on the Results screen but that are not available on the Run-in-Progress screen. B Locate the section that explains the instruments flags and messages in the Online Help System or the Instructions for Use manual. B Locate a sample result on the Results List screen. B Explain how to print or transmit results from the Results List screen.
B References
r r Heading 9.1 LOCATING THE SAMPLE RESULTS. Heading 9.2 AFTER LOCATING THE SAMPLE RESULTS. Heading 9.4 PRINTING SAMPLE RESULTS. Heading 9.5, ARCHIVING PATIENT RESULTS. Heading 9.7 REVIEWING RESULTS. Heading 9.8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT.
r r r 2.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the SAMPLE RESULTS MANAGEMENT BEFORE ARCHIVING SUMMARY.
1. 2. The instrument must be powered up. During this topic you will be reviewing information on the Run-in-Progress screen and comparing it to information on the Results screen. It is ideal if the last sample analyzed: a. b. c. Is a patient sample. Is run in the CBC/DIFF test panel. Appears on the Results List screen without manual matching.

Run-in-Progress Screen 1. 2. From the Main Menu screen, click to display the Run-in-Progress screen.
The Run-inProgress screen displays the results of the last sample ran, whether that sample was a background, a control, or a patient sample.
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PN 177196BB
3.
The fields on the left side of the Run-in-Progress screen give you sample information. a. The following fields are always filled: 1) 2) 3) 4) 5) 6) b. Sample ID Cassette and Position Number (Test) Panel Flagging Set Run Date and Time Gender (displayed as Unknown if a specific gender is not entered on a Worklist).
The remaining sample information fields are only filled if the information was supplied on a Worklist. The WBC parameter results include WBC count and WBC/BASO histogram. The RBC parameter results include RBC count, HGB, HCT, MCV, MCH, MCHC, RDW, and RBC histogram. The platelet parameter results include PLT count, MPV, and PLT histogram. Note: If the RUO parameters are enabled, the Plt parameters include PCT and PDW flagged with @.
4.
The fields in the middle of the Run-in-Progress screen give you the sample results. a. b. c.
d.
If a CBC/DIFF panel was analyzed, the percentage and absolute number for each differential parameter and the DiffPlot are also displayed. Note: If the RUO parameters are enabled, the differential parameters include ATL and IMM, flagged with @. 1) The diffPlot displays the four major white blood cell groups: a) b) c) d) 2) Lymphocytes Monocytes Neutrophils Eosinophils.
Basophil percentage is determined from the WBC/BASO histogram.
e.
Parameter results can be replaced by codes, such as ++++ and ...., or marked by flags next to the results, such as L or H, to alert you to a condition requiring further investigation. 1) 2) If any of the parameter codes or flags are displayed, this is a good time to review or introduce the information, whichever is applicable. The parameter codes and flags are covered in Parameter Flags under Heading 9.8, FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT, in the Online Help System or the Instructions for Use manual. 3) 4) The Patient and Action Range flags are covered under Heading 6.3, PATIENT/SAMPLE INFORMATION in this section of the Training Guide. Many of the other parameter codes are discussed under Heading 7.4, DATA ANALYSIS REVIEW - WBC PARAMETERS, Heading 7.5, DATA ANALYSIS REVIEW - RBC PARAMETERS, and Heading 7.6, DATA ANALYSIS REVIEW PLATELET PARAMETERS, in this Training Guide.
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6-19
5.
The Flags and Messages area on the far right of the Run-in-Progress screen displays messages generated by the instrument to help you evaluate the sample results. a. b. The Flags and Messages area can display flags and messages for QC, calibration, and reproducibility samples in addition to patient samples. The display is referred to as a tree view, which can be collapsed to show only the message categories or expanded to show the flags and messages for a category. 1) 2) c. 1) Clicking expands the list, clicking - collapses the list. Expand the tree view for a category as you discuss it. DiffPlot and Histogram Flags When the sample data exceeds preset regions on the DiffPlot or a histogram, a flag is generated and is posted under DiffPlot and Histogram Flags. 2) Analyzer Messages When the instrument detects a condition in the analytical process that could have affected the results generated, it posts an Analyzer Message. 3) Interpretive Messages Results that exceed predetermined abnormal limits trigger messages that are posted under Interpretive Messages to alert you to a possible pathological disorder that may require confirmation by suitable reference methods. 4) QA Messages When a sample is run after a control that has expired or failed, a message is posted under QA Messages until the problem is corrected. 5) Miscellaneous Messages Activities that could affect the results, such as matching the results manually or modifying the patient demographics, trigger messages that are posted as Miscellaneous Messages. 6) PLT Concentrate When a sample meets the criteria for a Plt concentrate (the PLT Concentrate Mode is active, the Hgb <2.0 g/dL, and the Plt >15.0 x 103/L), the instrument posts this message and flags the Plt results with a C to indicate extended linear and reportable range limits were used for the Plt results. Note: Enabling the PLT Concentrate Mode is a Service function. d. If any flags or messages are displayed in the expanded tree view, this is a good time to review or introduce this information, whichever is applicable. 1) The flags and messages that are posted in the Flags and Messages area are covered in Tree View Flags and Messages under Heading 9.8, FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT, in the Online Help System or the Instructions for Use manual. Many of the DiffPlot and Histogram messages are discussed under Heading 7.4, DATA ANALYSIS REVIEW - WBC PARAMETERS, Heading 7.5, DATA ANALYSIS REVIEW - RBC PARAMETERS, and Heading 7.6, DATA ANALYSIS REVIEW - PLATELET PARAMETERS, in this Training Guide. The QA Messages are discussed under Heading 4.2, ANALYZING CELL CONTROLS, in this Training Guide.
PN 177196BB
The categories displayed for patient runs are:
2)
3)
6-20
Results List Screen 1. After a sample is analyzed and its results are matched with its order, the results and any other sample information is posted to the Results List screen. Click a. b. c. to display the Results List screen.
2.
The Results List screen lists the results of all the samples that are either ready to be reported or that have been reported, but that have not been archived. The last sample analyzed and posted to this screen is at the top of the list (screen). Sort and filter options help you locate and manage the sample results on the Results List screen. 1) 2) You can sort the information in the Sample ID, Patient ID, or Run Date/Time columns in ascending or descending order. You can filter the results using any combination of the following criteria: a) b) c) d) e) f) 3) AF (lists all sample results with an analytical message) DH (lists all sample results with a DiffPlot/Histogram flag) PL (lists all sample results with a patient limits flag) AL (lists all sample results with an action limits flag) P (lists all sample results not printed) T (lists all sample results not transmitted).
Help the trainee find the procedure, Locating Results on the Results List Screen, under Heading 9.1, LOCATING SAMPLE RESULTS, in the Online Help System or the Instructions for Use manual, and encourage the trainee to use the sorting and filtering options.
d.
You can combine the filtering options with the print or transmit options on the Results List screen to selectively print or transmit sample results. 1) Click tt Print tab, review the print options available, then click cancel the request. Click to
2)
tt Transmit tab, review the transmit options available, then click to cancel the request.
3)
The procedures for printing and for transmitting sample results from the Results List screen is covered under Heading 9.4, PRINTING SAMPLE RESULTS, in the Online Help System or the Instructions for Use manual.
e.
You can archive results from the Results List screen. 1) 2) Click , review the archiving option available, then click the request. to cancel
The procedure for archiving sample results from the Results List screen is covered under Heading 9.5, ARCHIVING PATIENT RESULTS, in the Online Help System or the Instructions for Use manual.
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6-21
f.
You can access the Match screen from the Results List screen. 1) 2) Click to display the Match screen, then click to exit the screen.
Manual matching is discussed under Heading 6.9, MANUAL MATCHES, in this section of the Training Guide.
3.
Give the trainee a copy of the SAMPLE RESULTS MANAGEMENT BEFORE ARCHIVING SUMMARY, and review the procedures.
Results Screen 1. 2. 3. Selecting a sample on the Results List screen displays the Results screen for that sample. Have the trainee locate the sample results on the Results List screen that corresponds to the sample currently displayed on the Run-in-Progress screen and click on the results. Note that the Results screen looks very similar to the Run-in-Progress screen. a. b. c. 4. The fields on the left side of the screen give you sample information. The fields in the middle of the screen give you the sample results. The Flags and Messages area on the far right of the screen displays tree-view messages.
While the sample information and layout is the same for the two screens, the Results screen has four features that are not on the Run-in-Progress screen. Point out the following: a. Navigation arrows near the top allow you to scroll through the samples on the Results List screen, looking at the full patient reports without returning to the Results List screen. A rerun icon, , allows you to manually request a rerun of the specimen. Reruns are discussed under Heading 6.8, AUTOMATIC AND MANUAL SPECIMEN RERUNS in this section of the Training Guide. The Results field tells you how many samples (one or two) were ran for this Sample ID, and which sample is currently displayed. Note: 1 / 1 indicates only one sample from the specimen tube was ran, 1 / 2 indicates two samples from the same specimen tube were ran and these are the results of the first run, 2 / 2 indicates two samples from the same specimen tube were ran and these are the results of the second run. A comments icon,
, allows you to add comments about the results.
b.
c.
d.
Note: Remember that allows you to enter sample comments; to enter patient comments. 5. Obtain a printout of the sample results displayed on the Results screen. a.
allows you
If the instrument is set up to automatically printout patient reports, a printout should be available. If a printout is not available, click to print out the full patient report.
b. 6.
Compare the information on the printout to the information on the Results screen, pointing out the similarities and the differences.
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SAMPLE ANALYSIS AUTOMATIC AND MANUAL SPECIMEN RERUNS
6.8
AUTOMATIC AND MANUAL SPECIMEN RERUNS

A Objectives
When you have completed this topic, you will be able to: B Locate the procedure for rerunning samples in the Online Help System or the Instructions for Use manual.
B References
r Heading 8.6 RE-RUNNING SAMPLES Defining Automatic Rerun Criteria (By Flags and/or by Parameters) under Heading A.7 AUTO-FUNCTIONS SETUP.

1. 2. Two methods are available for rerunning specimens: automatic and manual. The automatic rerun is initiated by the instrument based on criteria chosen by the laboratory as part of the instrument setup. a. b. Selecting the criteria for doing an automatic rerun is covered under Heading 3.3, AUTO FUNCTIONS SETUP OPTIONS, in this Training Guide. To determine if the instrument is setup to mark specimens for rerun, from the Main Menu click 3. a. b. 4. tt tt Rerun tab.
The manual rerun is initiated by the Operator from the Results screen. Help the trainee find the procedure, Manual Reruns, under Heading 8.6 RE-RUNNING SAMPLES, in the Online Help System or the Instructions for Use manual. Have the trainee rerun a specimen or walk them through the procedure.
For both the automatic and the manual methods of initiating a rerun, the instrument automatically puts an order on the Worklist for that Sample ID. Note: The exception to this is if you use Cass./Position as the primary identifier and the sample was assigned an AUTO_SID. In that case, to rerun the specimen you must manually re-enter the specimen on the Worklist. To make sure you can distinguish between the results from the first run and the rerun: a. b. On the Results screen, the Results field displays 1 / 2 (one of two) for the first sample run and 2 / 2 (two of two) for the rerun. On the printout of the rerun, Yes appears next to Rerun on the report.
5.
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6-23
SAMPLE ANALYSIS MANUAL MATCHES
6.9
MANUAL MATCHES
A Objectives
When you have completed this topic, you will be able to: B List three circumstances under which the instrument may not be able to match sample results to the order. B State why the Manual Match option should be used when you are using a Worklist. B State why the Manual Match option should not be used if you are not using a Worklist. B Locate the procedure for manually matching result in the Online Help System or the Instructions for Use manual.
B References
Heading 9.3 MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS. Manual Match (Turning ON or Off) under Heading A.4 OPERATIONAL SETUP.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the SAMPLE RESULTS MANUAL MATCHING SUMMARY.
1. 2. 3. The instrument must be powered up. Either a Supervisor or Service must be logged in to view Setup options, but this is optional and is not required for covering the essential information in this topic. The ideal situation is to cover this topic when sample results are on the Match screen.

1. When you are using a Worklist, the instrument uses the positive ID (barcode or cassette/position number) to match the Worklist order with the appropriate sample results and automatically sends the results to the Results List. Under certain circumstances the instrument cannot match the results to the Worklist. a. If the barcode label is the positive ID and: 1) 2) b. 1) 2) 3. The Sample ID was not entered on the Worklist. The instrument could not read the barcode label and assigned an AUTO_SID. The cassette and position number was not entered on the Worklist. The cassette and position was entered on the Worklist, but the Sample ID that was read at that location was inconsistent.
2.
If cassette and position number is the positive ID and:
If the instrument cannot match the results and Manual Match is ON, the instrument: a. b. Sends the results to the Match screen for you to match. Flashes the Results icon, , to alert you.
4. 6-24
If the instrument cannot match the results and Manual Match is OFF:
PN 177196BB
a. b. 5.
The instrument reports the sample as it is analyzed. If the Sample ID is unknown it assigns an AUTO_SID number.
Even if Manual Match is OFF (disabled), the sample results are posted to the Match screen if the positive ID is set to Barcode (so a barcode Sample ID is expected) and the instrument does not obtain a barcode reading from the specimen tube. If you are using a Worklist, it is recommended that you enable the Manual Match option to ensure samples are reported with all the information on the Worklist order. If you are not using a Worklist, it is recommended that you disable Manual Match, as no result will have a match and all will be posted to the Match screen. The Manual Match option is enabled (or disabled) as part of the instrument setup. a. b.
Manual Match OFF is the default setting.
6. 7. 8.
The procedure for enabling this option, Manual Match (Turning ON or Off), is under Heading A.4 OPERATIONAL SETUP , in the Online Help System or the Instructions for Use manual. To view the current selection, from the Main menu click tt tt General.
c. 9.
If the laboratory plans to use a Worklist with Manual Match ON, help the trainee locate the Manual Match Procedure under 9.3 MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS in the Online Help System or the Instructions for Use manual. a. b. c. Click tt to display the Match screen.
If the Match screen has sample results that need to be matched, have the trainee use the procedure to make the matches. If the Match screen is empty, either walk the trainee through the procedure or create a situation that forces unmatched results and let the trainee match the results. Note: When Manual Match is ON, you can easily create an unmatched situation by running a specimen tube without first entering it on the Worklist. This creates a scenario where the trainee must first add the specimen order to the Worklist and then make the match.
10. After a samples results are manually matched: a. If the order that the results are matched with has a flagging set different from the one the sample was processed with, the results are recalculated using the orders flagging set and the results are marked with the Recalculated message. The results are moved from the the Match screen to the Results List screen. Note: Because reruns are requested from the Results List screen, results must be matched before they can be rerun. c. d. A Manual Match message (and a Recalculated message if applicable) is added under the Miscellaneous Message category in the Flags and Messages area of the report. The Run-in-Progress screen still displays Unmatched, but its printout is updated.
b.
11. Give the trainee a copy of the SAMPLE RESULTS MANUAL MATCHING SUMMARY, and review the procedure.
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7DATA MANAGEMENT AND REVIEW 7

7.1 DATA MANAGEMENT
A Objectives
When you have completed this topic, you will be able to: B B B B B Describe what type of results are stored in the database and how many results it hold. State the data management options offered at the beginning of a New Workday. Demonstrate how to search for the results of a specific sample. Demonstrate how to view and print the detailed results for a specific sample. Locate the procedures for tagging and batch printing, and/or batch transmitting, a group archived of results in the Online Help System or the Instructions for Use manual.
B References
r r Heading 5.4, NEW WORKDAY. Appendix E.1 DATABASE MANAGEMENT. Locating Archived Results procedure under Heading 9.1 LOCATING SAMPLE RESULTS.
r 2.
In Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide, locate and make a copy of the SAMPLE RESULTS MANAGEMENT AFTER ARCHIVING SUMMARY.
1. 2. The instrument must be powered up. You need to have some patient results stored in the archives.

Managing the Database 1. 2. All the instrument results, patient samples, blanks, reproducibility, control, and calibrator results, are stored in one large database. Patient sample results are not archived in the database until you select to archive them at the beginning of a New Workday or from the Results List screen. a. b. Click to display the Results List screen.
If any results are currently on the Results list screen and ready for archiving, click
3.
4.
and then to archive the results. Help the trainee locate Heading 5.4, NEW WORKDAY, in the Online Help System or the Instructions for Use manual, and review the New Workday concept and the Data Management options offered on a New Workday. To optimize performance, the system compacts the database at each login. The database compacting process begins when you log out and log in again.
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DATA MANAGEMENT AND REVIEW DATA MANAGEMENT
5.
The database can store 10,000 results. a. b. After 10,000 results have been stored, the system automatically deletes the oldest results having the oldest activity by Sample ID, leaving a maximum of 9,500 results. After the results are deleted, the system compacts the database to allow additional results to be stored.
Managing the Patient Data in the Archives 1. 2. An Operator can retrieve, review, print, or transmit data stored in the database. Click a. 1) 2) 3) b. to display the Archives screen. By the date of the run. By the patients Sample ID number By the patients last name.
Results can be retrieved from the archives in three ways:
The two icons on the upper right side of the screen, and , allow you to select between the screen for searching by run date versus the screen for searching by the patients ID (name or sample number). The screen that appears first by default is the screen for searching by run date. Have the trainee click click to view the screen for searching by patient ID and then
c. d.
to return to the screen for searching by run date. at this point takes you out of the Archives screens altogether.
Note: Selecting 3. a. b. c. d. 4.
Walk the trainee through retrieving a sample by run date. On the Run Date field, select the desired run date. From the list of patient results, click on a result to display. When the complete patient report is displayed, click Click to return to the Archives screen. to print the report.
Have the trainee click to display the information about the Archives screen and the procedures for retrieving sample results from the archives, and have the trainee use the procedure for retrieving results by patient ID, if applicable.
IMPORTANT Risk of compromising system functionality if you batch print and/or batch transmit while receiving a Worklist download from a host and/or while analyzing samples with Auto-Transmit and Auto-Print functions turned on. Always allow sample analysis and/or the host download to finish before batch printing and/or batch transmitting.
5.
Give the trainee a copy of the SAMPLE RESULTS MANAGEMENT AFTER ARCHIVING SUMMARY from this Training Guide and review the procedures.
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DATA MANAGEMENT AND REVIEW DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS
7.2
DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS

A Objectives
When you have completed this topic, you will be able to: B State the parameters derived from the dilutions made in each bath. B Briefly explain the sequential dilution system (SDS)
B References
1. 2. Bulletin 9151: AcV Differential Technology and Case Studies. In the Online Help System or the Instructions for Use manual, refer to: r Heading 2.5 SAMPLE ANALYSIS OVERVIEW. r Heading 2.6 SAMPLE ANALYSIS.
The information in this topic is versatile and could be used as a lead in or a review for several different topics, so just follow any special instructions for the topic you decide to use it with.

Preparing the Dilutions for Sample Analysis 1. During aspiration, whole blood is pulled into the sampling probe. a. b. c. 30 L of whole-blood is aspirated for a CBC panel. 53 L of whole-blood is aspirated for a CBC/DIFF panel.
2.
The volume of sample aspirated from the specimen tube into the sampling probe is sufficient to make all the dilutions needed to develop the parameter results for the selected test panel. The sample is partitioned as it is distributed to the baths in the baths assembly.
a.
3.
Use the illustrations on the next page as needed to explain the partitioning of the sample and the sequential dilution system (SDS). b. This information is covered under Heading 2.8, SAMPLE ANALYSIS OVERVIEW, in the Online Help System or the Instructions for Use manual. Dilutions are made in three of the baths for a CBC panel analysis: a. b. c. DIL1/HGB bath RBC bath WBC/BASO bath
4.
Dilutions are made in four of the baths for a CBC/DIFF panel analysis: a. DIL1/HGB bath b. DIFF bath c. RBC bath d. WBC/BASO bath Steps required to make these dilutions are detailed under Heading 8.2, RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION, in this Training Guide.
5.
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CBC Panel Sample Partitions inside Probe
CBC/DIFF Panel Sample Partitions inside Probe
Diluent
Diluent
Air bubble
Air bubble
Not used DIFF dilution
Not used WBC/BASO dilution RBC/PLT/HGB first dilution Not used

7616056A 7616056A 7616001A
WBC/BASO dilution RBC/PLT/HGB first dilution Not used

7616001A
Baths Assembly
WBC/ BASO RBC DIFF DIL1/HGB RINSE
Blood Segments are Dispensed Serially 1. The RBC/PLT/HGB segment is delivered to the DIL1/HGB bath. 2. The WBC/BASO segment is delivered to the WBC/BASO bath. 3. The DIFF segment is delivered to the DIFF bath.
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Dilution Used to Determine RBC and PLT Results 1. 2. The dilution made in the RBC bath is used to analyze red blood cells and platelets. The RBC bath dilution is prepared in two stages: a. b. 3. 4. Primary dilution: 10 L whole-blood is diluted with 1.7 mL of Diluent in the DIL1/HGB bath to form a 1:170 dilution (commonly referred to as first dilution) Secondary dilution: 42.5 L of this first dilution is transferred to the RBC bath where it is further diluted with 2.5 mL of Diluent to form final 1:10,000 dilution.
The cells in the final 1:10,000 dilution in the RBC bath are counted and sized using the Coulter principle. The final 1:10,000 dilution in the RBC bath is used to: a. b. c. d. Determine the RBC count. Develop the RBC histogram which is needed to obtain the Hct, MCV, and RDW parameter results. Determine the Plt count. Develop Plt histogram which is needed to obtain MPV, Pct, and PDW parameter results.
5.
Table 7.2-1 summarizes the dilutions made and the measurement method used to obtain the RBC and platelet data. This same information is covered in Table 2.3-2, Technical Characteristics for Obtaining RBC and Platelet Counts, in the Online Help System or the Instructions for Use manual.
Table 7.2-1 Technical Characteristics for Obtaining RBC and Platelet Counts Dilution Characteristics Primary Dilution for RBC and Plt: Initial volume of whole-blood Volume Diluent Primary dilution ratio Secondary Dilution for RBC and Plt: Volume of primary dilution Volume Diluent Secondary dilution ratio Final dilution for RBC and Plt results Reaction temperature Measurement Characteristics Method of analysis Aperture diameter Count vacuum Count period 42.5 L 2500 L 1:58.8 1:170 x 1:58.8 = 1:10,000 35C (95F) Coulter Principle 50 m 200 mb (5.9 in. Hg) 2 x 5 seconds 10 L 1700 L 1:170
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Dilution Used to Determine the Hemoglobin Result 1. 2. The final dilution made in the DIL1/HGB bath is used to determine the hemoglobin parameter result. The final dilution in the DIL1/HGB bath is prepared in three stages: a. b. Primary dilution: 10 L whole-blood is diluted with 1.7 mL of Diluent in the DIL1/HGB bath to form a 1:170 dilution (commonly referred to as the first dilution) Secondary dilution: 1) 2) 3. 4. 42.5 L of this first dilution is removed and 0.40 mL of Diluent is added. 0.4 mL of Hgb Lyse reagent is added to form the final 1:250 dilution.
Hemoglobin released by lysis of the red blood cells combines with potassium cyanide to form a cyanmethemoglobin compound. Hemoglobin concentration is determined based on transmittance of light through the optical part of the DIL1/HGB bath using a spectrophotometric technique at a wavelength of 550 nm. a. b. c. Transmittance of the sample dilution is compared to transmittance of a reagent blank. The Analyzer calculates Hgb using the blank and sample readings. The right-side panel of the Analyzer prevents ambient light from interfering with the Hgb measurements.
5.
Table 7.2-2 summarizes the dilutions made and the measurement method used to obtain the hemoglobin data. This same information is covered in Table 2.3-3, Technical Characteristics for the Measurement of the Hemoglobin, in the Online Help System or the Instructions for Use manual.
.
Table 7.2-2 Technical Characteristics for Obtaining Hemoglobin Results Dilution Characteristics Primary Dilution for Hgb: Volume of whole-blood Volume of Diluent Primary dilution ratio Secondary Dilution for Hgb: Volume of primary dilution removed Volume of additional Diluent Volume of Hgb Lyse Final dilution for Hgb determination Reaction temperature Measurement Characteristics Method of analysis Wavelength 42.5 L 400 L 400 L 1:250 35C (95F) Spectrophotometry 550 nm 10 L 1700 L 1:170
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Dilution Used to Determine the Reference WBC Count and the BASO Count 1. Two dilutions are required to obtain WBC count and differential parameter results: a. b. 2. 3. WBC/BASO dilution DIFF dilution
The final dilution in the WBC/BASO bath is used to determine the reference WBC count and the BASO count. The final dilution in the WBC/BASO is prepared by simultaneously delivering 10 L of whole-blood and 2.0 mL of WBC Lyse reagent into the WBC/BASO bath to form a 1:200 dilution. The Analyzer maintains the reagents and reaction at a regulated 35C (95F). The cells in the final 1:200 dilution in the WBC/BASO bath are counted and sized using the Coulter principle. The final 1:200 dilution inside the WBC/BASO bath is used to: a. b. Determine the WBC count Develop the WBC/BASO histogram, which is needed to obtain the BASO count.
4. 5. 6.
7. 8.
The WBC count and BASO count are determined simultaneously. When a CBC/DIFF panel is selected the WBC count is determined twice using two different methodologies. a. b. c. The count obtained in the WBC/BASO bath is the reference WBC count. The second WBC count is determined in the flow cell during acquisition of the DiffPlot. The dilution analyzed in the flow cell is prepared in the DIFF bath. WBC count results from the two methodologies are compared and if the results exceed predefined limits, the WBC count result is flagged.
9.
Table 7.2-3 summarizes the dilutions made and the measurement method used to obtain the WBC and basophil data. This same information is covered in Table 2.3-4, Characteristics Required to Obtain WBC/BASO Results, in the Online Help System or the Instructions for Use manual.
Table 7.2-3 Technical Characteristics for Obtaining WBC and BASO Results Dilution Characteristics Volume of whole-blood Volume WBC Lyse Dilution ratio Reaction temperature Measurement Characteristics Method of analysis Aperture diameter Count vacuum Count period 10 L 2,000 L 1:200 35C (95F) Coulter Principle 80 m 200 mb (5.9 in. Hg) 2 x 6 seconds
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Dilution Used to Determine LYMPH, MONO, NEUT, and EO Counts and a Secondary WBC Count 1. Two dilutions are required to obtain differential parameter results: a. b. 2. 3. WBC/BASO dilution DIFF dilution
The final dilution in the DIFF bath is used to determine lymphocytes, monocytes, neutrophils, and eosinophils counts and a secondary WBC count. The final dilution inside the DIFF bath is prepared in two stages. a. First stage: 25 L of whole-blood is delivered to DIFF bath in a flow of Fix reagent. 1) Dilution is incubated for 12 seconds, allowing the Fix reagent to lyse RBCs, stabilize WBCs in their native forms, and differentially stain lymphs, monos, neutrophils, and eos, with eosinophils staining most intensely. The Analyzer maintains the reagents and reaction at a regulated 35C (95F).
2) b. 4. 5.
Second stage: 1.0 mL of Diluent is added to the DIFF bath to stop the cytochemical reaction and form the final 1:80 dilution.
The final 1:80 dilution is transferred to the flow cell where each cell is measured for its impedance (volume) and absorbance (optical detection of cytochemistry changes). The final 1:80 dilution is analyzed in the flow cell to: a. Develop the DiffPlot from which four of the five WBC populations are determined: lymphocytes, monocytes, neutrophils, and eosinophils. Note: In a typical whole-blood sample, the basophil population (determined in the WBC/BASO bath) is very small compared to the other four WBC populations. b. Determine a secondary WBC count that is compared with the reference WBC count determined in the WBC/BASO bath; if WBC count results from the two methodologies exceed predefined limits, the WBC count result is flagged.
6.
Table 7.2-4 summarizes the dilutions made and the measurement methods used to obtain the DiffPlot data. This same information is covered in Table 2.3-5, Technical Characteristics for Acquisition of the DiffPlot, in the Online Help System or the Instructions for Use manual.
Table 7.2-4 Technical Characteristics for Obtaining the DiffPlot Dilution Characteristics Volume of whole-blood Volume of Fix Volume of Diluent Final dilution ratio Reaction temperature Incubation duration Methods of analysis 25 L 1000 L 1000 L 1:80 35C (95F) 12 seconds Coulter Principle and Optical Transmission with hydrofocusing 60 m 42 m 72 L 15 seconds 12 seconds
Measurement Characteristics
Aperture diameter Diameter of the flow Volume injected Injection duration Data accumulation
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DATA MANAGEMENT AND REVIEW DATA ANALYSIS - MEASUREMENT PRINCIPLES
7.3
DATA ANALYSIS - MEASUREMENT PRINCIPLES

A Objectives
When you have completed this topic, you will be able to: B B B B B State the Coulter Principle. State the relationship of resistance, cell volume, and pulse height. Define threshold, count periods, and voting. Explain the concept of channelization. Explain how pulses are used to develop a histogram.
B Briefly explain the ACV Technology.
B References
1. 2. Bulletin 9151: AcV Differential Technology and Case Studies. In the Online Help System or the Instructions for Use manual, refer to: r r r r
Heading 2.1 OVERVIEW. Heading 2.2 MEASUREMENT PRINCIPLES. Heading 2.3 AcV TECHNOLOGY. Heading 2.4 WBC/BASO TECHNOLOGY.
This topic is best covered in a classroom setting. Having a computer available to show where this information is located in the Instructions for Use Manual is desirable.

The Coulter Principle 1. The Coulter Principle is an electronic method of counting and sizing particles based on the fact that cells, which are poor conductors of a weak current, interrupt current flow. a. Cells, suspended in a conductive Diluent, are pulled through the aperture by a low vacuum; this creates a momentary increase in resistance to the electronic flow. 1) 2) b. Resistance creates a pulse that is sensed and counted by the instrument as a particle. The amount of resistance (the amplitude or height of each pulse) is directly related to the size (volume) of the particle that produced it.
2.
Impedance variation generated by the passage of nonconductive cells through a small, calibrated aperture is used to determine the count (number of particles) and size (volume) of the particles passing through the aperture within a given time period. This aperture sensing system is used to analyze the final dilutions in the RBC and WBC/BASO baths. a. The RBC bath aperture sensor system determines the cell count and size of RBCs and platelets.
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b.
The WBC/BASO bath aperture sensor system determines the cell count and size of WBCs. The WBC Lyse specific lytic action on the WBCs in this bath allows the system to further differentiate, by size, the basophils from the rest of the WBCs.
Aperture Sensor System
Solution to be analyzed Vacuum constant
Bath electrode (internal electrode)
Current constant Volts Electrodes Analyzing electronic circuit
Counting head (external electrode)
Pulse
Time
7650331A
Aperture
7196002B
3.
To sense particles using the Coulter Principle, a current flow is established through an aperture so that changes in that flow can be monitored. a. In this sensing system, an electrode is placed on each side of a calibrated aperture. 1) 2) 3) The most visible electrode (referred to as counting head) is the conductive metallic housing attached to the front of the RBC and WBC/BASO baths. The second electrode (referred to as the bath electrode) is not as conspicuous; this electrode is located inside the bath. The aperture is located between the counting head and the bath electrode. a) b) b. c. d. An 80 m aperture is used in the WBC/BASO bath. A 50 m aperture is used in the RBC bath.
When the count circuit is activated and an electronically conductive reagent is in the bath, an electric current continuously passes through the aperture. When cells are suspended in the conductive reagent and the cells are pulled through the aperture, the electrical resistance between the two electrodes increases. The count syringe supplies a constant low vacuum to the RBC bath and the WBC/BASO bath to pull the diluted sample through the aperture. The pulse is sensed and counted as a particle. The amplitude (height) of the pulse (the amount of resistance) is directly related to the size of the particle that produced it.
4.
The resistance created by a cell in the aperture generates an electrical pulse. a. b.
5.
Generated pulses have a very low voltage which an amplification circuit increases so that the electronic system can better analyze the pulses and eliminate the background noise.
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6.
Thresholds are used to exclude pulses from unwanted particles, such as debris, from analysis. a. b. A threshold is an electronically set size limit. Particles equal to or above the threshold are analyzed and particles below the threshold are excluded.
Histogram Development 1. A succession of thresholds are used to sort particles by size and produce a size distribution curve or histogram. a. b. The lowest threshold (T1) is sometimes referred to as the Base Threshold. The area between two adjacent thresholds is called a Channel. 1) 2) 3) 4) c. Channel 1 (C1) is between T1 and T2. Channel 2 (C2) is between T2 and T3, and so forth. Each threshold represents a size. For a particle to be counted in a particular channel, it must be larger than or equal to the lower threshold but smaller than the upper threshold.
To produce a particle size distribution curve or histogram, the number of particles is plotted on the Y-axis as Relative Number of particles and the particle size (or volume) on the X-axis as Femtoliters (fL). Histogram information can be used to determine the mean (average) size of the particles, the dispersion of particles around the mean size, and subpopulations within a main population. ACT 5diff AL instruments develop three histograms: WBC/BASO, RBC, and PLT.
d.
e.
7 6 T5 T4 T3 T2 T1 40 fl 35 fl 30 fl 25 fl 20 fl Channel 4 Channel 3 Channel 2 Channel 1

Number
5 4 3 2 1 0 5 10 15 20 25 30 35 40 45 50 C1 C2 C3 C4 Femtoliters
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ACV Differential Technology 1. In the AcV Technology, cells are cytochemically treated to preserves WBCs at their original size while differentially staining lymphocytes, monocytes, neutrophils, and eosinophils. The AcV Technology uses both the Coulter principle (to determine the cell volumes of the WBCs) and absorbance readings (to detect the difference in staining characteristics of the WBCs) to obtain data for developing the DiffPlot. Sequential analyses for cell volume (impedance) and light absorbance are performed in the flow cell. a. b. c. d. 4. A total of 72 L of sample from the DIFF bath is injected through the flow cell for 15 seconds. Data for developing the DiffPlot is accumulated in 12 seconds. Flow cell incorporates a 60 m aperture for cellular volume analysis and about a 40 m measurement area for light absorbance Flow cell lamp is a 20 watt incandescent tungsten-halogen lamp.
2.
3.
Each stained cell is individually focused and transported through the flow cell by sample pressure and Diluent sheath flow. a. The Dual Focused Flow (DFF) uses sheath fluid to surround and force cells suspended in Diluent to pass one at a time through the center of the flow cell (hydrodynamic focusing process). 1) 2) b. The first sheath flow focuses sample through the impedance aperture. The second sheath flow maintains the focused flow of cells as they exit the aperture into the optical flow cell.
Hydrodynamic focusing in the flow cell enables accurate and rapid cell-by-cell measurements on a large number of individual cells.
Dual Focused Flow (DFF)
5.
The Coulter Principle is used to measure the resistance of the WBCs in the impedance aperture. The change in electrical resistance is directly proportional to the cell volume.
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6.
Absorbance readings are taken on the cytochemically treated WBCs in the optical window of the flow cell. a. b. c. As a cell passes through the optical portion of the flow cell, light is scattered in all directions. Sensor detects only forward scattered light. Optical measurement is derived as a function of the amount of light lost due to diffraction and absorbance, as compared to full transmission when no cell is present.
Cell Measurement Components in Flow Cell
7.
Collected signals are converted into voltage pulses and are processed. a. a. Signals from the flow cell aperture and from the optical measurement are correlated by a window of time. The optical pulse must be detected within 100 to 300 microseconds of the impedance pulse; otherwise, the signal is rejected.
8.
Output signals from the focused flow impedance and the light absorbance measurements are combined to define the WBC differential population clusters: lymphocytes, monocytes, neutrophils, and eosinophils, and their precursors. a. b. The magnitude of the voltage pulses are proportional to the physical and chemical characteristics of the cells being analyzed. The light absorbance is related to cellular contents (granularity, nuclear content, and so forth) after cytochemical staining.
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Typical Absorbance Signals
9.
The DiffPlot is developed with optical transmission (absorbance) on the X-axis and volume on the Y-axis a. DiffPlot used to determine four of five leukocyte (white blood cell) populations: lymphocytes (LY), monocytes (MO), neutrophils (NE), and eosinophils (EO).
Combining Volume and Absorbance Data to Create a DiffPlot
b.
Changes in the morphology of a population are expressed on the DiffPlot by a shifting of the corresponding population. 1) 2) Volume and absorbance thresholds are used to detect shifting populations. Most of the population partition thresholds are fixed and give the limits of the morphological normality of leukocytes
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DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - WBC PARAMETERS
7.4
DATA ANALYSIS REVIEW - WBC PARAMETERS

A Objectives
When you have completed this topic, you will be able to: B List the individual parameters that comprise the WBC Profile. B Identify which parameters in the WBC Profile are directly measured, derived from the WBC/BASO histogram, derived from the DiffPlot, or computed. B Identify the flags that occur when the WBC count results do not agree. B Demonstrate how to locate details concerning flags, interpretive messages, or analytical alarms in the Online Help System or the Instructions for Use manual.
B References
1. 2. Bulletin 9151: AcV Differential Technology and Case Studies. In the Online Help System or the Instructions for Use manual, refer to:
r Heading 2.7 PARAMETER DEVELOPMENT. Heading 9.7 REVIEWING RESULTS. Heading 9.8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT.
r r

WBC Counts 1. 2. The reference WBC count is determined from the 1:200 dilution made in the WBC/BASO bath. The WBC Lyse reagent in the dilution: a. b. 3. Lyses the RBCs. Specifically differentiates between basophils and other WBCs by volume.
To obtain a WBC count, the Analyzer compares and votes on data from two 6-second count periods. a. If the two counts agree, the reference WBC counts reported. WBC count = Number of cells per volume x calibration factor WBC count displayed and printed as: WBC = N x 103 cells /L b. If the two counts differ more than predefined limit, WBC result is flagged with a voteout V-flag and the DIFF absolute numbers are also flagged with a V.
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4.
When the CBC/DIFF test panel is selected, a second WBC count is analyzed on the DIFF dilution in the flow cell during the acquisition of the DiffPlot. a. b. This WBC count is sometimes referred to as the secondary WBC count. This WBC count is compared to the WBC count from the WBC BASO bath and if the difference exceeds a preset limit, the WBC results are flagged. 1) 2) 3) If the WBC count from the flow cell exceeds the WBC count from the WBC/BASO bath by more than a predefined amount, DIFF+ is displayed. If the WBC count from the flow cell is less than the WBC count from the WBC/BASO bath by more than a predefined amount, DIFF- is displayed When a DIFF- or a DIFF+ flag occurs, the WBC count and all DIFF# parameters are flagged with an * (asterisk).
BASO Count 1. The basophils are determined simultaneously with the WBC count from the final 1:200 dilution in the WBC/BASO bath. a. b. 2. Raw data for developing the WBC/BASO histogram is collected through the two consecutive time periods of 6-seconds each (for a total of 12 seconds). Differentiation between the basophils and the other WBC is accomplished by means of the WBC Lyse-specific lytic action. One hundred percent (100%) of the leukocytes is represented by the total number of nucleated particles plus the basophils within area between thresholds labeled b and d. Basophils are located in the area between thresholds labeled c and d. Basophil percentage is calculated from number of particles existing in the area between thresholds labeled c and d
All the WBCs (including the basophils) are included on the WBC/BASO histogram. a.
b. c.
WBC
basophils
d.
BASO count = Number of cells per volume x calibration factor in a percentage relative to the number of counted cells (basophils plus other WBC nuclei) BASO% - WBC count BASO count = --------------------WBC%
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DiffPlot Development 1. The DiffPlot is developed from analysis of the DIFF dilution made in the DIFF bath. a. The Fix reagent in the final dilution lyses the RBCs, stabilizes the WBCs, and differentially stains the lymphocytes, monocytes, neutrophils, and eosinophils, with the eosinophils staining most intensely The dilution from the DIFF bath is injected through the flow cell for 15 seconds; for 12 of these 15 seconds, data for developing the DiffPlot is accumulated. Dual Focused Flow (DFF) fluid dynamics, which is a process by which individual cells are focused in a stream of Diluent (hydrodynamic focusing) Volume measurement (Coulter Principle) Measurement of transmitted light with zero degree (0) angle, which permits a response proportional to the internal structure of each cell and its absorbance.
b. 2.
DiffPlot analysis on an ACT 5diff AL analyzer is based on three essential principles: a. b. c.
3. 4.
From the measurements made in the flow cell, a DiffPlot is developed with optical transmission (absorbance) on the X-axis and volume (resistance) on the Y-axis. From the DiffPlot, neutrophil %, lymphocyte %, monocyte %, and eosinophil % are determined.
VOLUME
Monocytes Eosinophils
Neutrophils
Lymphs
ABSORBANCE
DiffPlot Regions 1. 2. 3. A study of the DiffPlot permits clear differentiation of four out of five WBC populations. In typical whole-blood sample, the basophil population is very small when compared with the other four white cell populations. Table 7.5 lists some of the characteristics of the normal WBC differential parameters and of immature WBCs. The illustration following the table shows the typical locations of immature WBC populations on the DiffPlot.
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Table 7.5 WBC Differential Parameter Characteristics NORMAL PARAMETERS Neutrophils PARAMETER CHARACTERISTICS r Neutrophils, with their cytoplasmic granules and segmented nuclei, scatter light according to their morphological complexity r Hypersegmented neutrophil gives an increased optical response when compared to a young neutrophil population r Higher the complexity of the cell, the further to the right they appear in the DiffPlot Lymphocytes r Lymphocytes, typically being small with regular shape are smaller in volume and lower in absorbance than the other cells, and are positioned in the lower region of the DiffPlot r Normal lymphocyte populations typically have a homogeneous volume with a Gaussian (bell-shaped) distribution r Large lymphocytes, reactive lymphoid forms, stimulated lymphocytes and plasma cells are found in the upper portion of the lymphocyte region r Lower area of the lymphocyte zone is normally empty; however, when small lymphocytes are present, a population may exist in this area r Presence of platelet aggregates is indicated by a distribution pattern that moves from the DiffPlot origin into the lymphocyte region r NRBC cytoplasmic membranes lyse like those of mature erythrocytes; small nuclei that remain appear in the debris and small lymphocyte regions Monocytes r Monocytes are typically large cells with a kidney-shaped nucleus and agranular (granule-free) cytoplasm r Cells neither scatter nor absorb large amounts of light and, therefore, are positioned in the lower end of the absorbance axis r Due to their size, monocytes are clearly positioned high on the volume axis r Very large monocytes may be found in the IMM (immature cell) region Eosinophils r With reagent action, eosinophils are the most intensely stained cells for optical separation r Due to the staining and their size, eosinophils show higher absorbance than neutrophils, but will be of similar volume Debris ABNORMAL PARAMETERS Immature Granulocytes r Platelets and debris from erythrocyte lysis represent the background debris population located in the lower region of the DiffPlot PARAMETER CHARACTERISTICS r Immature granulocytes are detected by their larger volume and by presence of granules that increase the intensity of scattered light r Due to their increased volume and similar absorbance, promyelocytes, myelocytes, and metamyelocytes are located above the neutrophil population and are typically counted as IMM cells; IMM cells are included in the reported neutrophil value Band Cells r Band cells are typically larger or of similar size to the neutrophils; however, due to their low level of cellular complexity, they absorb less light r Band cells tend to appear in the region between the neutrophils and the monocytes Blast Cells r Blast cells are generally larger than monocytes and have similar absorbance r When blast cells are present, generally located above the monocytes, which means they will be included in the IMM cell count r Small blasts will be located between the normal lymphocyte and monocyte populations
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Immature White Blood Cells on the DiffPlot

Blasts, Promyelocytes
VOLUME
Myelocytes, Metamyelocytes, Immature Neutrophils Immature Eosinophils Agranular Eosinophils Atypical Neutrophils Eosinophils
Monocytes Atypical Lymphs, Blasts Bands Lymphs Neutrophils
Abnormal Lymphs
ABSORBANCE
Debris, NRBCs, Lyse Resistant RBCs, Plt Aggregates
DiffPlot Thresholds
1. Volume and absorbance thresholds are used to detect shifting populations. a. b. 2. Most of the population partition thresholds are fixed and give the limits of the morphological normality of leukocytes. Changes in the morphology of a population are expressed on the DiffPlot by a shifting of the corresponding population. A review R-flag occurs on the DIFF parameter related to that region. Either DiffPlot and Histogram flags or Analytical Alarms occur to indicate the area within the DiffPlot that is affected. If an R-flag occurs on a DIFF parameter, further investigate the result.
When populations in DiffPlot exceed limits set for that region: a. b. c.
3.
Ten different flags may occur related to the position of the populations within the DiffPlot: r r r r r SL (small lymphocytes) SL1 (small lymphocytes 1) NL (neutrophil/lymphocyte) MN (monocyte/neutrophil) UM (upper monocyte) r r r r r LN (lower neutrophil) UN (upper neutrophil) NE (neutrophil/eosinophil) ATL (atypical lymphocytes) IMM (immature cells)
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Summary 1. 2. Table 7.6 summarizes the WBC parameters generated by the ACT 5diff instrument and how each is derived. For details on the methodologies used, review Heading 2.2 MEASUREMENT PRINCIPLES and Heading 2.7 PARAMETER DEVELOPMENT, in the Online Help System or the Instructions for Use manual. For details on the flags and interpretive messages for that can be generated, review Heading 9.8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT, in the Online Help System or the Instructions for Use manual.
3.
Table 7.6 WBC Parameter Summary Category Directly Measured Derived from the DiffPlot Parameter WBC (White Blood Count) BA % (Basophil Percentage) NE % (Neutrophil Percentage) LY % (Lymphocyte Percentage) MO % (Monocyte Percentage) EO % (Eosinophil Percentage) Computed NE # (Neutrophil Absolute Number) LY # (Lymphocyte Absolute Number) MO # (Monocyte Absolute Number) EO # (Eosinophil Absolute Number) BA # (Basophil Absolute Number) Source of Data Differential lysis plus Coulter Principle Differential lysis plus Coulter Principle ACV Technology ACV Technology ACV Technology ACV Technology Neut% WBC ---------------------------------100 Lymph% WBC --------------------------------------100 Mono% WBC ------------------------------------100 Eos% WBC -------------------------------100 Baso% WBC ----------------------------------100
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DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - RBC PARAMETERS
7.5
DATA ANALYSIS REVIEW - RBC PARAMETERS

A Objectives
When you have completed this topic, you will be able to: B List the individual parameters that comprise the RBC Profile. B Identify which parameters in the RBC Profile are directly measured, derived from the RBC histogram, or computed. B Compute MCV, MCH, and MCHC results. B Explain the process of building an RBC histogram. B Describe a typical RBC histogram. B Identify the flags that occur when the RBC count results do not agree. B Demonstrate how to locate details concerning flags, interpretive messages, or analytical alarms in the Online Help System or the Instructions for Use manual.
B References
r r

RBC Count 1. The RBC count is obtained from the RBC/PLT dilution in the RBC bath. a. b. Final 1:10,000 dilution in RBC bath that is often referred to as RBC/PLT dilution. RBC dilution contains red blood cells, white blood cells, and platelets. 1) 2) 2. Thresholds are used to separate platelet pulses, which are much smaller, from the red and white blood cell pulses. Since white blood cells fall in red blood cell size range, they are counted and sized as RBCs.
To obtain an RBC count result, the Analyzer compares and votes on data collected for two 6-second count periods. a. If the two counts agree, the RBC count is reported. RBC count = Number of cells counted per volume unit x calibration factor RBC count displayed and printed as: RBC = N x 106 cells /L
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b.
If the two counts differ by more than a predefined limit: 1) 2) RBC result is flagged with a voteout V-flag. MCV, MCH, MCHC, and RDW parameters are replaced with ( . . . .) code.
3.
Since WBCs fall in the red blood cell size range, they are counted and sized as RBCs when this 1:10,000 dilution is analyzed. Note: The WBCs are not gated out of the count because any interference is usually insignificant; there are normally very few WBCs (thousands) in comparison to the number of RBCs (millions). Only when the white count is markedly elevated is the red cell count or histogram influenced.
Hematocrit Measurement 1. The Hematocrit measurement is obtained from the RBC/PLT dilution in the RBC bath. a. b. 2. The height of the pulse generated by the passage of a cell through the aperture is directly proportional to the volume of the analyzed RBC. The hematocrit (Hct) is the sum of all the digitized pulses.
To obtain a hematocrit measurement, the Analyzer compares and votes on data collected for two 6-second count periods. a. If the two values agree, the Hct result is reported. Hct = Sum of digitized pulses x calibration factor Hct displayed and printed as a percentage (%) b. If the two values differ by more than a predefined limit: 1) 2) Hct result is flagged with a voteout V-flag. MCV and MCHC parameters are replaced with (. . . . ) code.
RBC Histogram 1. In addition to being counted, RBCs are categorized according to size (from 30 fL to 300 fL) by a 256-channel pulse-height analyzer. a. b. 2. Pulse-height analyzer uses a number of thresholds to sort the particles into several size (volume) categories and to develop a size distribution curve of the particles. Raw data for developing the RBC histogram is collected through two consecutive time periods of 6-seconds each (for a total of 12 seconds).
The RBC distribution curve reflects the native size of the red blood cells and any other particle in red blood cell size range. a. b. The RBC histogram provides the information for determining a helpful descriptor of the red cell population, RDW (Red cell Distribution Width). The RBC histogram is also used to determine if a red blood cell population is typical; if not, descriptive flagging is generated.
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c.
The following is an example of an RBC histogram with a normal RBC size distribution.
.
30
300
7616036A
RDW Determination 1. RDW (Red cell Distribution Width) is an index of the variation or spread in the size of the red blood cells. a. Study of RBC distribution detects erythrocyte anomalies linked to anisocytosis and enables clinician to follow evolution of the width of the curve relative to the cell number and average volume: 1) 2) b. Generally, as the red cell variation increases, width of the distribution curve broadens and visible asymmetry of the distribution curve is more likely. Width of the distribution curve, however, does not always indicate a true increase in size variation.
RDW index more accurately detects red cell variation than a visual inspection of the histogram (unless two distinct populations of cells are present). Note: A primarily microcytic population of red cells (decreased MCV) tends to have a tighter distribution (lower SD) than a normocytic population. A primarily macrocytic population of red cells (increased MCV) tends to have a wider distribution (higher SD) than a normocytic population.
2.
RDW is calculated using the standard deviation (SD) of the RBC population and the MCV and is displayed and printed as a percentage.
K SD -------------- = RDW (%) MCV
where: K = System constant SD = Calculated standard deviation based on the red cell distribution MCV = Mean Cell Volume of the red cells
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RBC Distribution Flags 1. Once an RBC distribution curve is developed, two positions on the distribution curve are located, RBC1 and RBC2.
RBC1 RBC2
30
300
7616057A
a. b. 2.
Thresholds RBC1 and RBC2 define the MICRO and MACRO regions and are calculated based on standard deviation (SD) of the RBC population. RBC1 threshold (monitoring area for microcytes) and RBC2 threshold (monitoring area for macrocytes) identify the points on the curve that are 2 SD from the mean. A MICRO flag is generated when the percentage of cells in the microcytic region compared to the total number of RBCs exceeds the preset default limit of 5%. A MACRO flag is generated when the percentage of cells in the macrocytic region compared to the total number of RBCs exceeds the preset default limit of 7.5%.
When too many RBCs fall within the MICRO or MACRO regions, a flag is generated. a. b.
Note: The MICRO and MACRO flags are independent of the Microcytosis and Macrocytosis flags that are generated from the Low and High patient limits 3. The laboratory may establish its own limits to replace the preset default values..
Hgb Determination 1. The Hgb determination is made on the final 1:250 dilution in the DIL1/HGB bath. a. The CBC lytic reagent in the dilution disrupts the RBCs to free the hemoglobin which combines with the potassium cyanide to form a stable cyanmethemoglobin compound. The converted hemoglobin is directly measured through the optical part of the DIL1/HGB bath using a spectrophotometric technique at a wavelength of 550 nm; the photometric technique is based on Beers Law. For each Hgb sample read value, the Analyzer takes three readings.
b.
c. 2.
Transmittance of the sample dilution is compared with the transmittance of a reagent blank. a. b. c. The Hgb blank value measured during the first patient cycle after a Startup cycle is stored as a reference blank; blank must be greater than 2.5 Vdc. During each analysis cycle, the Analyzer checks the measured Hgb blank against the stored Hgb blank reference value. If the new Hgb blank reference value is within 3% of the old reference value, the Hgb blank reference value is changed to this new value.
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3.
The system calculates the Hgb using both the blank and sample readings: Hgb result in g/dL represents: absorbance value obtained x calibration factor Hgb displayed and printed as: Hgb = N g/dL
4.
If the Hgb blank or Hgb read do not meet certain predefined limits, the following flags are generated: a. b. c. d. If the Hgb blank value is less than 2.5 Vdc, a reject R-flag occurs on the Hgb value. If the difference between the new Hgb blank reference value and the original Hgb blank reference value is greater than 3%, review R-flag is generated If three consecutive review R-flags occur on the Hgb blank reference value, (. . . .) code replaces the Hgb, MCH, and MCHC results. If the difference between the three reading taken on the Hgb sample exceeds the predefined limits, a voteout V-flag is generated.
5.
If the Hgb to Hct ratio is <0.8 or >1.2, the RBC, Hgb, MCV, Hct, MCH, MCHC, Plt, MPV, Pct, and PDW are flagged with *, indicating a possible error in the analytical process. The calculation for the Hgb to Hct ratio is:
Hgb g/dL 3 ------------------------------Hct %
MCV Calculation 1. 2. 3. MCV (Mean Cell Volume) is calculated using the Hct and the RBC count. Displayed and printed in femtoliters (fL) Note: 1 fL = 1 L3 Calculation for MCV is:
Hct ----------- 10 = MCV (fL) RBC
MCH Calculation 1. 2. 3. MCH (Mean Cell Hemoglobin) is calculated from the Hgb value and the RBC count and describes the average weight of hemoglobin in a red blood cell. Displayed and printed in picograms (pg) Calculation for MCH is:
Hgb ----------- 10 = MCH (pg) RBC
MCHC Calculation 1. 2. 3. MCHC (Mean Cell Hemoglobin Concentration) is calculated using the Hgb and Hct values and describes the average concentration of hemoglobin in the red blood cells. Displayed and printed in grams per deciliter Calculation for MCHC is:
Hgb --------- 100 = MCHC (g/dL) Hct
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Summary 1. 2. Table 7.7 summarizes the RBC parameters generated by the ACT 5diff instrument and how each is derived. For details on the methodologies used, review Heading 2.2 MEASUREMENT PRINCIPLES and Heading 2.7 PARAMETER DEVELOPMENT, in the Online Help System or the Instructions for Use manual. For details on the flags and interpretive messages for that can be generated, review Heading 9.8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT, in the Online Help System or the Instructions for Use manual.
3.
Table 7.7 RBC Parameter Summary Category Directly Measured Parameter RBC (Red Blood Count) Hgb (Hemoglobin Concentration) Hct (Hematocrit) Derived from the RBC Histogram Computed RDW (Red Cell Distribution Width) MCV (Mean Cell Volume) MCH (Mean Corpuscular Hemoglobin) MCHC (Mean Corpuscular Hemoglobin Concentration) Source of Data Coulter Principle Photometric Measurement Coulter Principle Histogram developed using Coulter Principle Hct 10 -------------------RBC Hgb 10 ---------------------RBC Hgb 100 ------------------------Hct
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DATA MANAGEMENT AND REVIEW DATA ANALYSIS REVIEW - PLATELET PARAMETERS
7.6
DATA ANALYSIS REVIEW - PLATELET PARAMETERS

A Objectives
When you have completed this topic, you will be able to: B List the individual parameters that comprise the PLT Profile. B Identify which parameters in the PLT Profile are directly measured, derived from the Plt histogram, or computed. B Explain the purpose the of rinse flow system. B Explain the process of building a PLT histogram. B Explain the area of a typical PLT histogram used to determine the MPV parameter result. B Explain the area of a typical PLT histogram used to determine the PDW parameter result. B Describe a typical PLT histogram. B Identify the flag that occurs when the PLT count results dont agree. B State the condition that generates an SCL flag. B When the MIC flag is generated, explain how you can determine if the platelet count and associated parameters are reliable. B Demonstrate how to locate details concerning flags, interpretive messages, or analytical alarms in the Online Help System or the Instructions for Use manual.
B References
r r

Plt Count 1. Plt parameters are obtained from the RBC/PLT dilution in RBC bath. a. b. c. d. Final 1:10,000 dilution in RBC bath that is often referred to as RBC/PLT dilution. RBC dilution contains red blood cells, white blood cells, and platelets. Thresholds are used to separate platelet pulses, which are much smaller, from the red and white blood cell pulses. Rinse flow is used to keep particles from re-entering the sensing zone.
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2.
Rinse flow is a steady stream of Diluent reagent that flows behind the RBC aperture during sensing periods. a. Without rinse flow (Figure A), there is a characteristic swirling of the dilution at the outlet of the aperture so that red (or white) cells caught up in these eddies behind the aperture may reenter the sensing zone and produce small pulses that could be counted as platelets. With rinse flow (Figure B), the steady stream of Diluent prevents the formation of these eddies.
b.
To waste
Cell Sensing zone
Cell
Swirling effect
Sensing zone
No rinse flow
Rinse flow
3.
To obtain a Plt count result, the Analyzer compares and votes on the data from the two 5-second count periods. a. If two counts agree, Plt count reported. Plt count = Number of cells counted per volume unit x calibration factor Plt count displayed and printed as: Plt = N x 103 cells /L b. If two counts differ more than the predefined limit, Plt result is flagged with a V.
PLT Histogram 1. Platelets are categorized according to size by a 256-channel pulse-height analyzer. a. Pulse-height analyzer uses a number of thresholds to sort the particles into several size (volume) categories and to develop a size distribution curve of the particles between 2 fL and 30 fL. Platelet histogram reflects the native size of the platelets and any other particle in the platelet size range.
b.
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c.
This illustration shows a PLT histogram with a typical platelet size distribution.
25fL
30
2.
The PLT histogram provides the information for determining a helpful descriptor of the platelet population: a. b. MPV (Mean Platelet Volume) PDW (Platelet Distribution Width)
3.
PLT histogram is also used to determine if a platelet population is typical; if not, descriptive flagging is generated.
MPV Measurement 1. 2. MPV (Mean Platelet Volume) is measured directly from analysis of the platelet distribution curve. MPV is displayed and printed in femtoliters (fL). Note: 1 fL = 1 L3 PDW Determination 1. PDW (Platelet Distribution Width) is determined from the PLT histogram as the width of the curve between S1 and S2. a. The illustration that follows shows the area of the PLT histogram that is used to determine the PDW parameter result.
15% S1
15%
PDW
S2
7615002A
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b.
In this example, S1 and S2 are placed so that: 1) 2) 15% of the platelets occur between 2 fL and S1. 15% of the platelets occur between S2 and the variable upper threshold. Note: This threshold is explained under the Detecting Abnormal Platelet Distributions that follows.
2. 3. 4.
PDW result is determined on the platelets between S1 and S2. PDW parameter result is displayed and printed as a percentage (%). PDW is not an FDA approved parameter; therefore, this parameter label and result are not routinely displayed in the United States, but may be routinely displayed in other countries.
Detecting Abnormal Platelet Distributions 1. The Analyzer evaluates each platelet distribution. a. b. c. d. When platelet histogram is being evaluated, a mobile threshold can move from its starting position at 25 fL to 18 fL. The computer searches for a valley between the platelet and red cell populations. If no valley is detected between 18 fL and 25 fL, the threshold remains at 25 fL and no flag is generated. In the typical platelet distribution that follows, no valley is detected between 18 fL and 25 fL, the threshold remains at 25 fL and no flag is generated.
25
30
2.
Particles of approximately platelet size can interfere with platelet histogram and count. a. Small particles, such as microbubbles or dust, can overlap the low end of the histogram. 1) If the number of pulses in the 2 to 3 fL region is higher than the predefined limits: a)
An SCL flag appears next to any Plt count >5.0 x 103/L to alert the Operator that a significant number of small cells or interference, such as microbubbles, are present. Note: If Plt <5.0 x 103/L, the SCL flag is not reported.
b) c) 2)
MPV, Pct, and PDW are reported as . . . .. In this scenario, rerun the specimen and verify the results.
In the Plt distribution that follows, small cells are present in the 2 fL and 3 fL regions.
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2 3
b.
Microcytic red cells can intrude at the upper end of the histogram. 1) If specimen contains microcytes, the Analyzer may be able to successfully eliminate the influence of this interference by repositioning the variable threshold (25 fL threshold) and excluding the microcytes. Three possible scenarios showing intrusion on the upper end of the platelet distribution are on the following page.
2)
Pct Calculation 1. Pct (plateletcrit or thrombocrit) is calculated according to the formula:

Plt ( 10 /L ) MPV (fL) -------------------------------------------------------------- = Pct% 10, 000
3
2. 3. 4.
Pct parameter result is displayed and printed as a percentage (%). No clinical significance has been identified for Pct parameter. Pct (and PDW) are not FDA approved parameters; therefore, these parameter labels and results are not routinely displayed in the United States, but may be routinely displayed in other countries.
Summary 1. 2. Table 7.8 summarizes the RBC parameters generated by the ACT 5diff instrument and how each is derived. For details on the methodologies used, review Heading 2.2 MEASUREMENT PRINCIPLES and Heading 2.7 PARAMETER DEVELOPMENT, in the Online Help System or the Instructions for Use manual. For details on the flags and interpretive messages for that can be generated, review Heading 9.8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT, in the Online Help System or the Instructions for Use manual.
3.
Table 7.8 Platelet Parameter Summary Category Directly Measured Derived from the PLT Histogram Computed Parameter Plt (Platelet Count) MPV (Mean Platelet Volume) PDW (Platelet Distribution Width) Pct (Plateletcrit) Source of Data Coulter Principle Histogram developed using Coulter Principle Histogram developed using Coulter Principle Plt count M P V ---------------------------------------10
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THREE HISTOGRAMS WITH INTRUSION ON UPPER END OF PLT DISTRIBUTION

Microcytic Interference with a Distinct Valley between 18 fL and 25 fL 1. If intrusion of microcytes creates a valley between the 25 fL and the 18 fL thresholds, the 25 fL threshold is repositioned at the valley to minimize interference to platelet parameter results. 2. When this occurs, reported platelet result is acceptable; however, MIC (microcytes) flag appears to alert Operator that microcytes are present.
18
25fL
30
Microcytic Interference with a Valley below 18 fL 1. If microcytes are extremely small so that the valley between the platelet population and the microcyte population falls below the 18 fL limit, the threshold is placed at the 18 fL limit. 2. When this occurs, MIC flag appears and the platelet count is flagged to alert the Operator that the extremely small microcytes present in this sample could not be eliminated. 3. Platelet count and associated parameters are not reliable and should be verified by an alternative method.
3 18 25fL 30
Interference with No Distinct Valley 1. Interference present in the upper area of the platelet distribution curve blending with the platelet population so that there is no clear distinction between the platelets and the interference suggests the presence of schistocytes (fragmented red cells) or platelet aggregates (platelet clumps). 2. If threshold cannot be positioned in the 25 fL to 18 fL region, threshold defaults to 18 fL position. 3. SCH (schistocytes) flag appears and the platelet count is flagged to alert the Operator that the interference (which is most likely either schistocytes or platelet clumps) could not be eliminated. 4. PLT count and associated parameters are not reliable and must be verified by an alternative method.
18
25fL
30
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8SYSTEM DIAGNOSTICS AND MAINTENANCE 8

8.1 ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS
A Objectives
When you have completed this topic, you will be able to: B Access and identify the main components in the ACT 5diff AL system.
B References
Heading 11.3 REMOVING PANELS/COVERS. Heading 11.8 COMPONENT LOCATIONS.
Copies of the SYSTEM POWER DOWN SUMMARY and SYSTEM POWER UP SUMMARY pages from Chapter 9, SUMMARY AND QUICK REFERENCE MASTERS, of this Training Guide.
1. 2. If you already have the system powered down and instrument covers off, you can use the illustrations in this topic to identify components for the trainee. If, in addition to identifying components, you want to use this topic to reinforce the power down/power up procedure or to teach the panel and cover removal procedures, you should start with the system powered up and all doors, covers, and panels in place. Note: The following training format assumes you are starting with the instrument powered up and all doors, covers, and panels in place.

1. Most of the mechanical components are covered by panels or covers for your protection during normal operation of the instrument. a. b. Three of these covers, the right and left front doors and the right-side panel also have interlocks that inhibit operation if the door/panel is not in place. For your safety during troubleshooting, you must power down the instrument before removing covers that access moving mechanical components or electrical components. Always follow the cover/panel removal directions in the Online Help System or the Instructions for Use manual, carefully and completely.
c. 2.
Help the trainee find and print copies of the procedures for removing panels and covers under Heading 11.3, REMOVING PANELS/COVERS, in the Online Help System or the Instructions for Use manual. Note: If the trainee is using a laptop computer to view the Instructions for Use manual and the laptop can be located near the instrument for easy reference, it is not necessary to print these procedures.
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SYSTEM DIAGNOSTICS AND MAINTENANCE ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS
3.
The Power Down/Power Up procedures are covered under Heading 2.5, SYSTEM POWER DOWN PROCEDURE, and Heading 2.6, SYSTEM POWER UP PROCEDURE, in this Training Guide. a. b. If you have not covered the Power Down/Power Up procedures with the trainee yet, it would be a good idea to do that now. If you have already covered the Power Down/Power Up procedures with the trainee, have the trainee use the SYSTEM POWER DOWN SUMMARY to power down the instrument.
4.
Help the trainee use the cover removal procedures under Heading 11.3, REMOVING PANELS/COVERS, in the Online Help System or the Instructions for Use manual to: a. b. c. d. Lower the left and right front doors. Remove the right-side panel. Remove the left-side panel. Remove the top cover.
Note: The Service trainer can, at their discretion, also remove the right cover (over the Main card) and the front cover to identify the components in those locations. Procedures are not provided in the Online Help System or the Instructions for Use manual, for removing those covers as the Operator would not normally need to access those areas. 5. Once the panels and covers are off: a. b. 6. Use the illustrations in this section to identify the mechanical components. Use the alphabetized list of component functions that follows the illustrations as desired to introduce/review the component functions. If you plan to cover the sample flow next, leave the system powered down and the covers and panels off and go to Heading 8.2, RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION, in this Training Guide. Otherwise, have the trainee reinstall panels and covers, close doors, and power up the system.
When you have completed this topic: a.
b.
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PN 177196BB
Upper Compartment/Front Cover
LEDs Power switch Needle position switches
Tube holder Piercing mechanism motor
7616266D
Tube height switch
Tube detect switch
Traverse home sensor
Lower Front Compartment

Cassette transfer mechanism Cassette position left switch Tube holder detection switches Cassette position right switch Front cover interlock
Cassette input stop-right switch
Tube mixer Bar-code arm reader
Cassette input stop-left switch
Front cover interlock
Cassette input mechanism motor
Motor Transfer Cassette card home transfer sensor mechanism motor
Tube holder assembly position switches
Cassette ejection pushers
Cassette output position switch

7616278D
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8-3
Right Side and Main Card Compartments

Traverse card Main card Probe home sensor Horizontal traverse assembly LV20 to LV23 Vertical traverse assembly Sampling syringe Output area full switch Power supply DIFF DIL1/HGB bath RINSE bath bath RBC WBC/BASO bath bath
Waste syringe 1 LV24 to LV30 Diluent reservoir Bath shield
Counting heads Hgb photometer Drain/debubble baths
Baths assembly LV31 to LV35 Bath enclosure door interlock
7616275D
Left Side and Motor Card Compartments

Fan Flow-cell lamp assembly Optical Preamplifier card
Optical bench
Waste syringe 2
LV1 to LV12
Count syringe assembly LV13 to LV19

7616129D
DIFF syringe assembly
Reagent syringes assembly
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Table 8.1 Fluidic and Mechanical Modules/Components Component/Module Bar-code reader (internal) Bath enclosure area interlock Bath enclosure heater Baths assembly Functions Reads the cassette and specimen tube bar-code labels. Prevents the Analyzer from cycling when the right-side panel is removed. Maintains the temperature in the bath enclosure area. A collection of baths which, with the exception of the RINSE bath, hold the sample dilutions in a temperature controlled area for mixing and analysis. The RINSE bath collects waste from the sampling probe. Pushes the cassettes onto the cassette output tray for retrieval by the Operator. Operates the cassette loading pushers. Stops the cassette input mechanism motor. Stops the cassette input mechanism motor and signals that a cassette is present. Push the cassettes from the cassette input tray onto the transport track for pickup by the cassette transfer mechanism. Stops the cassette transfer mechanism motor when the cassette reaches the position for ejection onto the cassette output tray. Works in conjunction with the cassette position-right switch to keep track of the position of the cassette, telling the computer which tube will be pierced next. Works in conjunction with the cassette position-left switch to keep track of the position of the cassette, telling the computer which tube will be pierced next. Moves the cassette transfer mechanism left and right along the transfer track. Note: Because the motor can run in reverse, a cassette can be moved back to the sampling area to rerun a specimen. Cassette transfer mechanism Picks up a cassette from the cassette input tray, moves the cassette along the transfer track for mixing, identification by the bar-code reader, and sample aspiration, then deposits the cassette in front of the cassette output tray and activates the cassette ejection pushers. Provides the vacuum needed for: r Counting WBCs and BASOs. r Counting RBCs and PLTs. r Draining the WBC bath via isolator 3. Counting heads DIFF (flow cell) lamp DIFF syringe assembly The external electrodes used for applying the Coulter Principle to the cells in the RBC and WBC/BASO baths. Provides the light for determining the absorbance readings on the stained WBC in the flow cell. Contains three syringes, from left to right - the inner sheath, the outer sheath, and the sample injector. This assembly: r Dispenses a measured amount of Diluent in the DIFF bath to stop the cytochemical reaction. r Injects the sample into the flow cell. r Dispenses the inner and outer sheath Diluent to the flow cell. Diluent reservoir r Holds the Diluent needed for an analysis cycle. r Eliminates risk of Diluent degassing as it is aspirated by syringes.
Cassette ejection pushers Cassette input mechanism motor Cassette input stop-left switch Cassette input stop-right switch Cassette loading pushers Cassette output position switch Cassette position-left switch Cassette position-right switch Cassette transfer mechanism motor
Count syringe
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Table 8.1 Fluidic and Mechanical Modules/Components (Continued) Component/Module Drain/debubble baths Flow cell Front door interlocks Hgb photometer Horizontal traverse assembly Needle position switches Functions Prevents any contamination from going back into the baths when mixing bubbles are dispensed into the baths. Houses and provides path through apertures for DC gain and absorbance measurements. (Not shown. Inside optical bench) Prevent the Analyzer from cycling when the left or the right front door are open. Measures light transmittance through the optical part of the DIL 1/HGB bath for Hgb determination. Supports the vertical traverse assembly and moves it horizontally over the baths for distribution of the sample. Update the computer with the position of the piercing needle and identify the Analyzer as not an OV instrument. Troubleshooting Tip: If these switches are misadjusted, the software may identify the Analyzer as an OV instrument. Optical bench assembly Output area full switch Piercing mechanism motor Power switch Probe home sensor Reagent heating coil assembly Reagent syringes assembly Houses the flow cell, the DIFF lamp, and the Optical Preamplifier card, and provides adjustments for these components. Tells the system that the cassette output tray is full (ten cassettes) and stops Analyzer until Operator removes cassettes. Drives the gear mechanism that moves the needle for piercing the cap of the specimen tube. Turns power to Analyzer off and on. Detects when the sampling probe is in its home position. Preheats the reagent used to make the dilutions. Contains five syringes that draw a measured quantity of reagent and dispense it to the appropriate bath to make the dilutions. From left to right, the syringes draw: r Lysing agent for the Hgb (Hgb Lyse). r Cleaning agent (Rinse). r Lysing agent for the DIFF (Fix). r Diluent (Diluent) for all the dilutions except the Diluent used to stop the cytochemical reaction for the DIFF parameters. r Lysing agent for the WBC/BASO (WBC Lyse). Sampling probe Sampling syringe Pathway for sample aspiration and dispensing. r Aspirates a sample from the specimen tube and distributes portions of that sample to the DIL 1/HGB, DIFF, and WBC/BASO baths for dilution. r Removes a sample from the first dilution (made in the DIL 1/HGB bath) and dispenses it into the RBC bath. Solenoid valve assemblies Transfer home sensor Traverse home sensor Tube detect switch Tube height switch LV1 to LV12, LV13 to LV19, LV20 to LV23, LV24 to LV30 , LV31 to LV35 Detects when the cassette transfer mechanism is at its home position. Detects when the horizontal traverse assembly is at its home position. Detects if a tube is in a cassette position. Mechanically pushes a high tube down and if it cannot do that, stops the Analyzer with an alarm.
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PN 177196BB
SYSTEM DIAGNOSTICS AND MAINTENANCE RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION
Table 8.1 Fluidic and Mechanical Modules/Components (Continued) Component/Module Tube holder Tube holder detection switches Tube holder assembly position switches Tube mixer arm Vertical traverse assembly Functions Holds the tube in the correct position for piercing. Detects the position of the tube holder, identifying which hole is in the piercing position. Detects the three positions of the tube holder assembly: open, closed, and sampling (initiates a cycle). Removes the specimen tubes from the cassette, one or two at a time, mixes them and returns them to the cassette. r Supports the sampling syringe r Moves the piercing needle down for piercing the specimen tube r Moves the probe down into the specimen tubes and the baths, so that samples can be aspirated and dispensed. Waste syringe 1 r Provides the vacuum that drains the RBC, DIL 1/ Hgb, and RINSE baths to isolator 2. r Provides the pressure for mixing bubbles in the RBC and DIL 1/ Hgb baths. Waste syringe 2 r Provides the vacuum that drains the DIFF bath via isolator 1, that pulls DIFF sample from the DIFF bath toward the sample injector syringe, that fills the diluent reservoir, and that suctions the end of the probe. r Provides pressure for mixing bubbles in the DIFF bath.
8.2
RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE DESCRIPTION

A Objectives
When you have completed this topic, you will be able to: B B B B B B B B B B Identify and describe the functions of the main components used in sample flow. Identify the start conditions prior to initiating a cycle. Identify the pierce position. Explain how the final RBC/Plt dilution is made, including reagents used in the process. Explain how the WBC/BASO dilution is made, including reagents used in the process. Explain how the DIFF dilution is made, including reagents used in the process. Explain how the final Hgb dilution is made, including reagents used in the process. Explain what portions of the cycle are eliminated by selecting the CBC panel. Explain how the tangential flow of reagent mixes the sample and reagent. Explain the purpose of the mixing bubbles entering the DIL1/HGB bath.
B References
The cycle description is not covered as a separate topic in the Online Help System or the Instructions for Use manual. To review sample dilution preparation or sample analysis characteristics, refer to:
r r Heading 2.5 SAMPLE ANALYSIS OVERVIEW Heading 2.6 SAMPLE ANALYSIS
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8-7
The instrument must be powered down and the left- and right-side panels and the top cover must be removed.

1. 2. One important tool for troubleshooting an instrument is being familiar with what the instrument does when it is operating normally. This topic walks you through the normal flow of a sample in the instrument as it is aspirated, diluted, and analyzed. a. b. The emphasis in this topic is on how the sample is prepared for analysis and where the analysis takes place. When you have completed this topic, you may want to follow it with a review of the measurement principles and characteristics covered under Heading 7.2, DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS, and Heading 7.3, DATA ANALYSIS - MEASUREMENT PRINCIPLES, in this Training Guide.
3.
The interlocks will prevent you from cycling this instrument with the doors open and covers and panels. a. If the Key Operator is the trainer, this topic must be done as a walk-through with the power off. The illustrations in this section are provided to help the trainee visualize the cycle flow. If a Service Representative is the trainer, this topic can be done as a walk-through or the Service trainer can power up, log in as Service, and cycle blood while explaining the cycle flow.
b.
4. 5.
Whether you do this as a walk-through or as a wet demonstration, you are exposing yourself to mechanical and biological hazards and must take appropriate precautions. The following explanation assumes the CBC/DIFF test panel is selected. If the CBC test panel were used, the dilution made in the DIFF bath would be skipped.
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PN 177196BB
Pre-Cycle Instrument Conditions 1. 2. 3. 4. The green LED is glowing indicating the Analyzer is ready. The RINSE bath is empty. The DIL 1/HGB, DIFF , and RBC baths contain clean Diluent. The WBC/BASO bath contains a mixture of Diluent and Rinse reagent.
RINSE
DIL 1 HGB
DIFF
RBC
BASO WBC
7616225D
Initiating an Instrument Cycle 1. To initiate a cycle in the Manual mode: a. At the Workstation, select the Manual mode and click b. .
7616226D
2.
When the tube holder door opens, place a tube of a well-mixed whole-blood specimen in the tube holder and push the door to the sampling position. Note: When the door is in the sampling position, the probe pierces the tube occupying the home (12 oclock) position in the tube holder. For different tubes, you rotate the tube holder to bring the desired tube to the home position. To initiate a cycle in the Autoloader mode: Load a cassette with specimen tubes and place the cassette in the cassette input tray. At the Workstation, select the Autoloader mode.
a. b.
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Preparing for Sample Processing 1. After the cycle is initiated: a. b. The sampling probe moves to the pierce position. The sampling probe move down to the vial, the needle pierces the cap, and the sampling probe moves to the correct level in the vial to aspirate a sample of blood. 1) 2)
RINSE DIL 1 HGB DIFF RBC BASO WBC
7616225D
53 L in the CBC/DIFF mode. 30 L in the CBC mode.
2.
All the baths drain.
Rinsing the Probe Exterior After Aspiration 1. 2. The horizontal traverse assembly positions the sampling probe over the RINSE bath. The 3 L sample aliquot at the tip of the sampling probe is discarded into the RINSE bath as the exterior of the sampling probe is rinsed. Discarding this aliquot helps ensure sample integrity. Dispensing an aliquot of the sample into the RINSE bath begins the sample partitioning for the sequential dilution system. a.
3.
At this point you may want to refer to Heading 7.2, DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND MEASUREMENTS, in this Training Guide and review the information under Preparing the Dilutions for Sample Analysis. If you are letting the instrument cycle as you explain the flow, you may want to have the trainee focus on the sampling probe for one cycle as it dispenses sample.
b.
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PN 177196BB
1.
Probe
Each aliquotted sample is delivered to its appropriate bath using a tangential flow of reagent which mixes the diluted sample and minimizes viscosity problems. To create this tangential flow: a. The reagent delivery port is positioned so that reagent is delivered tangentially to the wall of the bath, that is the reagent flows along the walls of the bath. The tip of the sampling probe is aligned with this delivery port on the bath.
2.
Reagent input
b.
Tangential flow
3.
Bath
7616002A
Simultaneous delivery of sample and reagent at a single point on the curved wall of the bath: a. b. Sets up a flow that produces a thoroughly mixed dilution. Sets up a consistent (counterclockwise) swirling motion that ensures reproducible sample delivery from the probe.
4. 5.
Point out the angled reagent delivery port on each dilution bath. If you are letting the instrument cycle as you explain the flow, you may want to have the trainee focus on sample/reagent delivery into each bath. The horizontal traverse assembly positions the sampling probe over the DIL 1/HGB bath. The vertical traverse assembly moves the probe downward into the bath. The probe tip is positioned so that a tangential flow can occur as blood and reagent are delivered to the bath. 10 L of the whole-blood sample partitioned for making the first dilution and 1.7 mL of Diluent are simultaneously dispensed into the DIL 1/HGB bath. Mixing bubbles enter the bath to make a uniform suspension of cells. This 1:170 dilution is commonly referred to as the first dilution.
Making the First Dilution 1. 2.
3.
4.
5.
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8-11
Making the WBC/BASO Dilution 1. 2. The horizontal traverse assembly positions the sampling probe over the WBC/BASO bath. The vertical traverse assembly moves the probe downward into the bath. The tip of the probe is positioned so that a tangential flow can occur. 10 L of the whole-blood sample and 2.0 mL of WBC Lyse are simultaneously dispensed into the bath, making a final dilution of 1:200. Mixing bubbles enter the bath to make a uniform suspension of cells. The WBC Lyse destroys the RBCs and the specific lytic action on the WBCs differentiates the basophils from other WBCs. 5. This dilution is used to: a. b. Making the DIFF Dilution 1. 2. The horizontal traverse assembly moves the sampling probe over the DIFF bath. The vertical traverse assembly moves the probe downward into the bath. The tip of the probe is positioned so that a tangential flow can occur. 25 L of the whole-blood sample and 1.0 mL of Fix reagent are simultaneously dispensed into the bath. Mixing bubbles enter the bath to make a uniform suspension of cells. The Fix reagent lyses the red blood cells, stabilizes the WBCs in their native form, and differentially stains the lymphocytes, monocytes, neutrophils, and eosinophils, with the eosinophils staining most intensely. 5. After 12 seconds of incubation, the staining process inside the DIFF bath is stabilized by adding another 1.0 mL of Diluent which stops the cytochemical reaction and makes a final dilution of 1:80. This dilution is used to: a. b. Count WBCs for a secondary WBC count. Develop the DiffPlot for detemining the percent of lymphs, monos, neuts and eos. Determine the WBC count Develop the WBC/BASO histogram from which the BASO count is obtained.
3.
4.
RINSE
DIL 1 HGB
DIFF
RBC
BASO WBC
3.
4.
RINSE
DIL 1 HGB
DIFF
RBC
BASO WBC
6.
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PN 177196BB
Double Rinsing the Sampling Probe 1. 2. The horizontal traverse assembly moves the sampling probe over the RINSE bath. A double rinsing (interior and exterior) of the probe removes residual whole-blood sample from inside the probe. a. b. In the CBC/DIFF mode, 5 L is discarded in the RINSE bath. In the CBC mode, 7 L is discarded in the RINSE bath.
RINSE
DIL 1 HGB
DIFF
RBC
BASO WBC
Aspirating from the First Dilution 1. 2. 3. The horizontal traverse assembly moves the sampling probe over the DIL 1/HGB bath. The vertical traverse assembly moves the probe downward into the bath. 42.5 L of the 1:170 first dilution is aspirated into the sampling probe.
RINSE
DIL 1 HGB
DIFF
RBC
BASO WBC
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8-13
Making the Hgb Dilution 1. 2. The vertical traverse assembly moves the probe up, out of the dilution in the bath. While the probe is still inside the DIL 1/HGB bath, an additional 0.4 mL of Diluent is added to the bath through the reagent port. 0.4 mL of Hgb Lyse is added to the bath, making a final dilution of 1:250. The Hgb Lyse reagent rapidly destroys the red blood cells and converts a substantial proportion of the hemoglobin to a stable pigment so a hemoglobin value can be determined. 4.
3.
Mixing bubbles enter the bath to ensure a uniform dilution. This dilution is used to measure the hemoglobin. The sampling probe is returned over the RINSE bath. The piercing needle is rinsed, drop retraction takes place and both the probe and the needle are air dried.
5. 6.
Making the RBC/Plt Dilution 1. 2. The horizontal traverse assembly moves the sampling probe over the RBC bath. The vertical traverse assembly moves the probe downward into the bath. The tip of the probe is positioned so that a tangential flow of reagent can occur. 42.5 L of the 1:170 dilution obtained from the DIL 1/HGB bath and 2.0 mL of Diluent are simultaneously dispensed into the RBC bath. An additional 0.5 mL of Diluent is dispensed through the sampling probe at the end of the second dilution, making a final dilution of 1:10,000. Mixing bubbles enter the bath to ensure a uniform dilution. This dilution is used to: a. b. c. Count the RBCs. Develop an RBC histogram. Develop a PLT histogram.
3.
4.
RINSE
DIL 1 HGB
DIFF
RBC
BASO WBC
5. 6.
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PN 177196BB
Rinsing the Baths 1. After analysis of the dilution in the WBC/BASO bath, the horizontal traverse assembly moves to the WBC/BASO bath and the WBC/BASO bath is drained. The sampling probe is rinsed with Diluent and Rinse reagent (cleaning agent) is delivered into the WBC/BASO bath. Note: This mixture of Diluent and Rinse reagent is pulled through the aperture in the WBC/BASO bath, cleaning that aperture and providing a restricted flow of reagent for the sweep flow behind the RBC/Plt aperture.
RINSE
2.
DIL 1 HGB
DIFF
RBC
BASO WBC
3.
After analysis of the dilutions in the DIL 1/HGB, DIFF , and RBC baths, the baths are drained and clean Diluent is added. The hemolgobin blank is read on the clean Diluent in the DIL 1/HGB bath. The horizontal traverse assembly returns to the sampling position. The sampling syringe moves down creating the air gap for the next cycle.
4. Preparing for the Next Sample 1. 2.
Dilution Summary
Bath DIL1/HGB Dilution Components 1. 10 L whole-blood sample + 1.7 mL Diluent 2. 42.5 L of the first dilution is removed 0.40 mL of Diluent added while probe is still in bath 3. 0.4 mL Hgb Lyse reagent added DIFF 1. 25 L whole-blood sample + 1.0 mL Fix reagent 2. 12 second incubation 3. 1.0 mL of Diluent added RBC 1. 42.5 L of the first 1:170 dilution 2. 2.5 mL of Diluent added WBC/BASO 10 L whole-blood sample + 2.0 mL WBC Lyse reagent 1:200 1:10,000 1:80 DiffPlot development and secondary WBC count RBC count and RBC and PLT histograms development WBC count and WBC/BASO histogram development Final Dilution Ratio 1:250 Final Dilution Function Hgb measurement
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SYSTEM DIAGNOSTICS AND MAINTENANCE BASIC TROUBLESHOOTING TECHNIQUES
8.3
BASIC TROUBLESHOOTING TECHNIQUES

A Objectives
When you have completed this topic, you will be able to: B Recognize an instrument problem based on abnormal sample results. B Recognize an instrument problem based on abnormal Startup results. B Recognize an instrument problem based on abnormal control results. B Recognize an instrument problem based error messages. B Explain how knowing a normal cycle flow and how the parameters are derived can help locate a problem.
B References
1. In the Online Help System or the Instructions for Use manual, refer to: r r r 2.
Viewing Startup Results under Heading 5.3 POWERING UP AND LOGGING ON/POWERING DOWN AND LOGGING OFF . Reviewing Control Results under Heading 7.3 RUNNING CELL CONTROLS. Heading 11.11 REPLACEMENT PROCEDURES.
In this Training Guide, under Heading 4.3, INTERPRETING AND USING CELL CONTROL DATA, refer to: r r r WHAT TO DO WHEN A CBC/DIFF CONTROL IS OUTSIDE ITS EXPECTED RANGES. USE GRAPHS TO DETECT PROBLEMS AND POINT TO SOLUTIONS. WHAT TO DO IF AN XB/XM BATCH IS OUT.
This topic is best covered in a classroom setting. Most of this topic refers to material that was presented as part of learning the normal operation of the instrument. Show where this information is located in the Instructions for Use manual, or to review it, is desirable.

How to Recognize an Instrument Problem 1. The instrument provides at least one of three clues whenever a problem exists. a. The data generated is not as expected. This data can include: 1) 2) 3) 4) 5) b. c. Startup cycle results Commercial cell controls XM analysis Patient samples IQAP
The instrument does not sound or look right when it is operating. The instrument generates an error message.
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PN 177196BB
2.
Once you recognize a problem, you need to locate and correct the problem. The Three Steps to More Efficient Troubleshooting that follows provides a good guide.
Three Steps to More Efficient Troubleshooting

1
Be completely familiar with normal operation. a. b. Start Up, Sample Analysis, Shut Down Normal Sample Flow 1) 2) Know what should be happening during each part of the cycle. Become familiar with the normal sounds of operation
Use a logical approach to obtain a clear symptom and isolate the components involved a. b. c. Use the error message information as a starting point Use your knowledge of sample flow Use your knowledge of each subsystem
Acquire the knowledge and skills necessary to locate and correct problems. a. b. c. Use the instrument Read the manuals and become familiar with the kind of information they contain Call your Beckman Coulter Representative
Troubleshooting through Cycle Observation 1. To successfully troubleshoot this instrument, you must: a. b. c. 2. 3. 4. Become completely familiar with normal sample flow. Know what should be happening during each part of the cycle. Be familiar with the normal sounds of operation.
This type of knowledge is gained mostly through experience. To increase your familiarity and your comfort level with the normal sample flow of this instrument, periodically review the Cycle Description in this Training Guide. The Key Operator should know normal sample flow well enough to verbally describe the normal operation sequence without the aid of a document.
Troubleshooting by Instrument Subsystems 1. You can divide the instrument into three instrument subsystems: a. b. c. Electronic Reagent Fluidic 1) 2) 2. Pneumatics (pressures and vacuums) Hydraulics (liquids)
As you try to logically determine the source of a problem, consider the following hints about each subsystem. Many of these hints refer to knowledge you have already gained from other topics but may not have considered its application to problem solving.
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3.
Electronic Subsystem a. If there is no power: 1) 2) 3) b. Check to see if one of the indicator lights is on. Check power switches. Check plug connections.
If the flow cell lamp is burned out, replace it. Refer to Heading 11.11 REPLACEMENT PROCEDURES, in the Online Help System or the Instructions for Use manual. Level Sensing 1) 2) A float-level sensor is used to monitor the waste container level. Cycle counters monitor the reagent levels.
4.
Reagent Subsystem a.
b.
Replacement procedures. To replace a reagent or waste container, refer to Heading 11.11 REPLACEMENT PROCEDURES, in the Online Help System or the Instructions for Use manual. Reagent related problems 1) 2) 3) 4) May be contaminated May be expired May have been frozen causing the ingredients to separate May be the source of electrical interference due to electrolytic characteristics
c.
5.
Fluidic Subsystem a. Key Components 1) 2) 3) 4) b. 1) Tubing Valves Syringes Solenoids Check tubing connections and routing: a) b) c) 2) c. 1) At the reagent container. At all associated syringe assemblies. Throughout the Analyzer.
Hydraulics
Check associated syringes, valves, and solenoids. Low vacuum a) b) c) d) Generated by the count syringe Equivalent to 5.9 inches of mercury Also called aperture vacuum Pulls the dilutions through the RBC and WBC apertures and sweep-flow Diluent behind the RBC aperture.
Pneumatics
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PN 177196BB
SYSTEM DIAGNOSTICS AND MAINTENANCE SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS
2)
Pressure. Used for dispensing reagents from pumps, opening pinch valves, and moving air cylinder shafts.
Troubleshooting Using System Messages, Special Procedures, and System Diagnostics This information is covered as a separate topic, Heading 8.4, SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS, next in this section of the Training Guide.
8.4
SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS

A Objectives
When you have completed this topic, you will be able to: B Demonstrate how to access the Alarms and Errors log. B Demonstrate that you can locate the System Message table in the Online Help System or the Instructions for Use manual. B Use the User Diagnostics Tests to check hardware components. B State at least one situation when performing a reproducibility check would be beneficial. B Demonstrate that you can locate the Troubleshooting Guide in the Online Help System or the Instructions for Use manual.
B References
r r Heading 11.14 SYSTEM ERRORS Heading 11.5 DIAGNOSTICS MENU SCREEN
r r
Heading 11.8 REPRODUCIBILITY CHECK

Heading 11.15 TROUBLESHOOTING GUIDES.
The instrument must be powered up so you can access the software screens.

Error Messages and Error Message Tables 1. When the instrument generates an error message, it posts the error in the Alarms and Errors log and a. b. 2. flashes. Clicking on the flashing icon:
Acknowledges the error. Opens the Alarms and Errors log.
You can also open the Alarms and Errors message from the Main Menu screen. a. From the Main Menu screen, click Errors log. 1) tt to access the Alarms and
The most recent entry is displayed on the top of the log screen.
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2) 3) 4)
The log entry includes the date and time of the event, the name of the Operator logged in, and the name of the error message posted. The Alarms and Errors log saves entries for up to one year.
b. 3.
Prior entries to the log are deleted on a first in, first out basis as the capacity is exceeded. To add comments to an entry, click on the entry and then on the Add Comments button.
Help the trainee locate the error message tables under Heading 11.14 SYSTEM ERRORS in the Online Help System or the Instructions for Use manual. a. b. The message table is an alphabetized list of the error and system messages generated by the instrument. The table includes the probable cause of each message and the action to take.
Troubleshooting Using Special Procedures 1. The reproducibility check shows how close several results (from the same specimen) are to each other; in other words, this check measures repeatability or precision. a. b. 2. 3. Reproducibility does not measure accuracy, but true accuracy is not possible unless the instrument is precise. Doing a reproducibility check before doing a calibration procedure might catch imprecision problems that could affect the calibration process.
Carryover is the interaction of the previous sample with the current sample. If either reproducibility or carryover are out of specification limits, it could adversely affect the data. a. b. These procedures are discussed under Heading 4.6, REPRODUCIBILITY AND CARRYOVER CHECKS, in this Training Guide. The procedures for checking reproducibility in either the Manual mode or the Autoloader mode, are covered under Heading 11.8 REPRODUCIBILITY CHECK, in the Online Help System or the Instructions for Use manual.
Troubleshooting Using Instrument Diagnostics 1. The instrument has several diagnostic functions that allow you to check the Analyzers hardware. From the Main Menu screen, click tt Diagnostics) Hardware Systems screen. a. This screen has five tabs. 1) 2) 3) 4) 5) b. 8-20
Hardware Reset Motors Valves Sensors Autoloader Test
2.
tt
to access the (Users
The options accessed by these five tabs allow you to check the instrument hardware.
PN 177196BB
3.
Click Hardware Reset tt Run. a. b. c. You can hear the instrument as it resets components to a home position. The status bar at the bottom of the screen displays Hardware Reset while the reset is in progress. You should do a Hardware Reset: 1) 2) 3) 4) If the instrument halts due to error. After an emergency stop of the instrument. When the instrument reports a faulty operation. When prompted by the instrument.
4.
Click the Motors tab. a. b. The Motors screen allows you to energize any motor individually to see if it is working correctly. Click the Cassette Input Mechanism button, and notice the cassette pushers in the cassette input tray are moved as their motor is energized. Click to return to the Hardware Systems screen.
c. 5. a. b.
Click the Valves tab. The Valves screen allows you to energize banks of solenoids. Click the Valves 1 to 12 button and listen to the cadence as each solenoid is fired (energized). Click to return to the Hardware Systems screen.
c. 6.
Click the Sensors tab to view the state, de-activated or activated, of each of the instruments sensors. a. b. A sensor is displayed as green when it is de-activated, red when it is activated. Close the cassette input -right or cassette input - left switch and notice the color changes to red. Click to return to the Hardware Systems screen.
c. 7. a.
Click the Autoloader Test tab. This screen allows you to test the Autoloader function to ensure that the system detects the tubes in the correct position and with the correct barcode, if applicable. If you want to see how to do this test, click and select the link to the Autoloader Test. Close the Online Help System. to open the Online Help System
b. c.
Troubleshooting Using the Troubleshooting Guides 1. 2.

PN 177196BB
Have the trainee locate Heading 11.15 TROUBLESHOOTING GUIDES, in the Online Help System or the Instructions for Use manual. Review the problems and actions covered in that section. 8-21
SYSTEM DIAGNOSTICS AND MAINTENANCE PREVENTIVE MAINTENANCE
8.5
PREVENTIVE MAINTENANCE
A Objectives
When you have completed this topic, you will be able to: B Name the maintenance procedures required and state how often they must be done. B Demonstrate how to access the Maintenance log. B Locate the procedure for making an entry in the Maintenance log.
B References
r Heading 11.2 MAINTENANCE SCHEDULE Heading 11.16 LOGS
The instrument must be powered up for accessing the Maintenance log.

1. 2. 3. Proper maintenance of your ACT 5diff AL hematology analyzer is the best way to ensure good performance. Failure to do the maintenance procedures correctly and on a timely basis may compromise instrument performance. Maintenance procedures you must do are based either on a time schedule or on an as needed basis. a. b. c. d. 4. Startup and Shutdown are daily maintenance procedures Calibration is as needed or when required by your laboratory or regulatory agency Replacing reagents or the rinse drain filter are as needed procedures Extended cleaning is an as needed procedure
Maintenance done by your Beckman Service Representative is based on the number of cycles; therefore, how often the maintenance procedure needs to be done is driven by your laboratorys workload. From the Main Menu screen, click a. b. c. d. tt to access the Maintenance log.
5.
The most recent log entry is displayed on the top of the log screen. The Maintenance log saves entries for up to five years. Prior entries in the log are deleted on a first in, first out basis as the capacity is exceeded. The system does not automatically make entries into the Maintenance log; when you do a maintenance operation, you must enter the information in the log.
6.
Have the trainee locate the procedure, Adding Entries to the Maintenance Log, under Heading 11.16 LOGS, In the Online Help System or the Instructions for Use manual.
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PN 177196BB
9SUMMARY AND QUICK REFERENCE MASTERS 9

9.1 SUMMARY PAGES
What Are Summary Pages?
A summary page contains an abbreviated version of essential operating instructions detailed in the On-Line Help system and the Instructions for Use manual.
Purpose
Each summary page in this section is an individual, stand-alone document that can be copied for use in the laboratory as a training aid for new Operators and as a quick reference tool for trained Operators while operating the instrument.
Design
These summary pages are designed for ease of use by newly trained Operators as well as experienced Operators. As you examine these summary pages, notice that most summaries consist of two levels of detail. The first level states the actual task (in bold) and the second level supplies abbreviated instructions for completing the task. Newly trained Operators may need to use all the information provided on a summary page. As their skills develop however, they will have progressively less need for the abbreviated instructions to complete each task. Experienced Operators may use a summary page more as a quick reference to make sure they have completed all the required steps in the proper sequence. Summary pages are not designed to replace the detailed operating instructions provided by the On-Line Help system and the Instructions for Use manual and should not be used by untrained Operators.
9.2
QUICK REFERENCES PAGES

What Are Quick Reference Pages?
A quick reference page supplies detailed information needed frequently in the daily operation of the instrument, such as the software menu paths.
Purpose
Like the summary pages, each quick reference page in this section is an individual, stand-alone document that can be copied for use in the laboratory as a training aid for new Operators and as a quick reference tool for trained Operators while operating the instrument.
9.3
CONTENTS
Since summary and quick reference pages are designed to be used as stand-alone documents, consecutive page numbering is not used on these pages. Instead the footer shows the total number of pages for example, 2 of 2 appears on page 2 of a 2-page summary or quick reference and 1 of 1 appears on a single page summary or quick reference. To assist you in locating a summary page (since the page numbering is not sequential), the summary page master are inserted first, arranged in alphabetical order, followed by the quick reference page masters.
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9-1
SUMMARY AND QUICK REFERENCE MASTERS CONTENTS
In an electronic Training Guide you can use the following links to access the .pdf file of a summary page or a quick reference page master. r Summary Page Masters t t t t t t t t t t t t t t t t t t r t t t
CONTROL ANALYSIS SUMMARY CONTROL DATA MANAGEMENT SUMMARY CONTROL FILE SETUP AND MODIFICATION SUMMARY ONLINE HELP SYSTEM REAGENT REPLACEMENT SUMMARY SAMPLE ANALYSIS IN AL MODE: BARCODE POSITIVE ID WITH WORKLIST SUMMARY SAMPLE ANALYSIS IN AL MODE: BARCODE POSITIVE ID WITHOUT WORKLIST SUMMARY SAMPLE ANALYSIS IN AL MODE: CASS/POS POSITIVE ID WITH WORKLIST SUMMARY SAMPLE ANALYSIS IN AL MODE: CASS/POS POSITIVE ID WITHOUT WORKLIST SUMMARY SAMPLE ANALYSIS IN MANUAL MODE SUMMARY SAMPLE RESULTS MANAGEMENT AFTER ARCHIVING SUMMARY SAMPLE RESULTS MANAGEMENT BEFORE ARCHIVING SUMMARY SAMPLE RESULTS MANUAL MATCHING SUMMARY SHUTDOWN SUMMARY STARTUP SUMMARY SYSTEM POWER DOWN SUMMARY SYSTEM POWER UP SUMMARY WASTE CONTAINER REPLACEMENT SUMMARY CASSETTES QUICK REFERENCE SOFTWARE ICONS AND MENU PATHS QUICK REFERENCE TUBE HOLDERS QUICK REFERENCE
Quick Reference Page Masters
9-2
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TRAINING CHECKLIST
OFFICIAL TRAINING DOCUMENTATION (for COULTER ACT 5diff AL Hematology Analyzer Training)
ACCOUNT INFORMATION
Laboratory Address
Phone ACT 5diff AL Analyzer Serial Number Key Operator/Trainee Installation Date Training Dates Beckman Coulter Representative/Authorized Trainer
PURPOSE
This Training Checklist provides a comprehensive list of tasks and topics that should be completed by a Beckman Coulter Representative as part of installing the COULTER ACT 5diff AL Hematology Analyzer and training the Key Operator. The Key Operator can in turn use this Training Checklist when training other operators to document which topics were covered.
INSTRUCTIONS
1. 2. Make a copy of this Training Checklist for each trainee. At the completion of the training, the trainer and the trainee should review the Training Checklist together and place a check mark ( ) in the box next to any task or topic that both agree was completed. If a task or topic does not apply to the trainee, note the reason in the comments section. Both the trainer and the trainee should sign the Training Checklist.
3. 4.
CHECKLIST
INSTALLATION
B Verify that the instrument was installed by a Beckman Coulter Representative according to the instructions in the Service manual. B Verify that the instrument is accessible to the Service Representative. B Verify that the ventilation requirement is met. Comments: _____________________________________________________________________________ _____________________________________________________________________________
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TRAINING CHECKLIST CHECKLIST
GENERAL
B Describe the intended use of the instrument, including the parameters reported. B Demonstrate how to access and use Online Help. B Demonstrate how to view the video procedures. B Demonstrate how to view and print the Instructions for Use, Host Transmission Specification, and this Training Guide from the Online Help System. B Describe how to order the optional printed version of the Instructions for Use if desired. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
INSTRUMENT COMPONENTS
Identify and locate the following instrument components: B Analyzer power switch B Red and green system indicator lights (LEDs) B Reagent compartment B Cassette input and output trays B Cassettes B Tube holder door B Manual-mode tube holders (two) B Traverse assembly with sampling probe and sampling syringe B Baths assembly (RINSE, DIL1/HGB, DIFF , RBC, and WBC/BASO baths) B Diluent reservoir B Waste syringe 1 B Waste syringe 2 B Counting syringe B Diff syringe assembly B Reagent syringes assembly B Optical bench B Computer B Monitor B Keyboard and mouse B Printer Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
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REAGENTS
Identify and locate each reagent. B ACT 5diff Diluent B ACT 5diff WBC Lyse B ACT 5diff Hgb Lyse B ACT 5diff Fix B ACT 5diff Rinse Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
GETTING STARTED
B Discuss and do the Power Up procedure. B Discuss and do the Power Down procedure. B Review the log in and log out procedures. B Review the use of barcodes, Autoloader-mode cassettes, and Manual-mode tube holders. B Review the Main Menu screen elements. B Review the Generic and Contextual toolbars available on every screen. B Review the software screens available from the Main Menu screen. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
DAILY ROUTINE
B Discuss and do the Startup procedure. B Discuss and do the Shutdown procedure. B Discuss and do a Mini-Clean cycle. B Explain the Beginning of Workday. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
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CALIBRATION
B Review recommendations and frequency. B Review the package insert. B Do the precalibration checks. B Demonstrate the Diskette download. B Explain the calibration procedure and guide the trainee through it. B Review the manual method of obtaining and entering calibration factors. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
QUALITY ASSURANCE
B Demonstrate how to set up control files. B Discuss importance of quality control. B Review the control assay sheet. B Discuss and demonstrate control handling techniques. B Discuss control stability. B Run controls. B Review control results. B Review control files. B Review the XB/XM method of Quality Assurance. B Explain the IQAP program and procedure for submitting control data. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
SAMPLE HANDLING
B Review the requirements for specimen collection, sample handling, storage, and mixing for venous and micro collection samples. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
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SAMPLE ANALYSIS
B Discuss worklist options. B Discuss the workflow options available and do the workflow setup (refer to scenarios). B Run patient samples in the Autoloader mode. B Run patient samples in the Manual mode. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
DATA REVIEW
B Demonstrate how to locate samples on the Run-in-Progress screen. B Demonstrate how to locate samples on the Results List screen. B Demonstrate how to display the Results screen for a sample. B Review the screen elements of the Results screen. B Demonstrate how to locate samples in the archives. B Discuss how to delete samples and patient files from the archives. B Discuss sample association. B Discuss the role of the Manual Match option in sample association. B Demonstrate printing. B Review normal sample results. B Discuss each type of parameter flag or code that can be used on sample results, including the DataPlot and Histogram flags. B Discuss the instrument generated interpretive messages. B Discuss the instrument generated analytical messages. B Discuss the instrument generated quality assurance messages. B Discuss the instrument generated miscellaneous messages. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
SPECIAL PROCEDURES/DIAGNOSTICS
Discuss the following, demonstrating a procedure or locating it in the Instructions for Use manual whenever appropriate: B Maintenance schedule B Instrument logs B System errors B Hardware reset B System diagnostics
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B Cleaning procedures B Reagent container replacement B Waste container replacement B Lamp replacement B Rinse drain filter replacement Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
MAINTAINING AND SERVICING THE INSTRUMENT

B Discuss the importance of general maintenance. B Discuss telephone troubleshooting availability and its importance for minimizing downtime. B Discuss service procedures and expectations. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
INSTRUMENT SETUP/CUSTOMIZATION
Miscellaneous B Auto-Numbering B Default (test) Panel B Worklist - Positive Identifier B Worklist - Manual Match B Logs Comments B RUO Parameters B Auto-Stop for QA Messages B Auto-Stop for Consecutive Results (sample characteristics) B Location (patient) B Physician (name) B Units (format for numeric results) Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
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Quality Assurance Setup B Shifts B Quality Assurance Settings Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Auto Functions Setup B Rerun B Auto-Print (patient samples results) B Auto-Transmit (patient samples results) Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ System Setup B Local Settings (time, date, and language) B Host Communications B Printer Characteristics (driver, paper-size, and print quality) B Auto-Print (quality control, reproducibility, calibration, or startup results) B Printed Report (customized header and content) B Auto-Clean Frequency B Daily Workload B New Workday B Automatic Startup B Automatic Shutdown Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Operator Setup B Password setup/hierarchy. B Users list Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
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Flagging Sets Setup B Default B Edited/Created Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
USING THE ONLINE HELP/INSTRUCTIONS FOR USE MANUAL

Locate and review the following procedures or sections in the documentation: B Power Up B Power Down B Startup B Shutdown B Running Cell Controls B Running Manual (STAT) Mode Samples B Running Autoloader Mode Samples B Calibration B Maintenance B Setup
PAPERWORK
B Review the installation report with the customer and ensure it includes a copy of the control results. B Discuss the purpose and importance of documenting daily procedures, controls, reagents, and maintenance. B Complete this Training Checklist. Place the original in the Laboratory Log book. The Beckman Coulter Representative should Fax a copy of the signed training checklist to: Miami Education Center (305) 380-5022. B Complete a Training Checklist for each operator trained on the instrument. B Ensure the customer service telephone number is clearly noted. B Attach a copy of the Setup Report to this checklist. Comments: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
________________________________________ Trainee Signature
________________________________________ Trainer Signature
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TRADEMARKS
Beckman Coulter, the stylized logo, and COULTER are trademarks of Beckman Coulter, Inc. and are registered with the USPTO.
All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders. Find us on the World Wide Web at: www.beckmancoulter.com Made in USA
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Documentation COULTER AC T 5diff AL Hematology Analyzer Documentation

s Instructions for Use PN 624026 Use and Function Operation Principles Specifications/Characteristics Precautions/Hazards Running Samples Reviewing Results Calibration Diagnostics Instrument Setup Barcode Specifications Log Sheets Manual Calibration Workstation Management Printout Formats Worklist Scenarios References Glossary Abbreviations Index Requirements for interfacing the system with a host computer. Training information for using the AL system. Tube List information
s s s
Host Transmission Specification PN 4277065 Training Guide PN 177196 Hematology Tube List PN A70017
Come visit us at www.beckmancoulter.com
Printed on Recycled Paper Copyright Beckman Coulter, Inc. 2002 - 2012 All Rights Reserved

ATC 5diff Manual

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COULTER ACT 5diff Autoloader Hematology Analyzer

Operators Training Guide

WARNINGS AND PRECAUTIONS

3.4 3.5 3.6 3.7 4

TRAINING CHECKLIST, 1 ACCOUNT INFORMATION, 1 PURPOSE, 1 INSTRUCTIONS, 1 CHECKLIST, 1 TRADEMARKS, 1

Key Operators Responsibility

INTRODUCTION ABOUT THIS TRAINING GUIDE

ABOUT THIS TRAINING GUIDE

promote or reinforce learning the topic material.

INTRODUCTION SAFETY SYMBOLS

Conditional hazard. Possibility of a hazard based on specific conditions.

1GETTING TO KNOW YOUR INSTRUMENT 1

D Topic Notes and Tasks

GETTING TO KNOW YOUR INSTRUMENT WORKSTATION HARDWARE

controls operation of the numeric keypad a) b) c) d)

GETTING TO KNOW YOUR INSTRUMENT WORKSTATION HARDWARE

WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM

D Topic Notes and Tasks

Prints data to a Printer or transmits data to the Host computer.

Allows you to add information.

Saves information or validates an action.

Cancels unsaved changes or actions.

GETTING TO KNOW YOUR INSTRUMENT PRINTER

D Topic Notes and Tasks

GETTING TO KNOW YOUR INSTRUMENT BAR-CODE SCANNER (OPTIONAL)

Identify the following Printer components. a. b.

BAR-CODE SCANNER (OPTIONAL)

D Topic Notes and Tasks

GETTING TO KNOW YOUR INSTRUMENT ANALYZER

GETTING TO KNOW YOUR INSTRUMENT ANALYZER

Any screen on which the Generic toolbar icons displayed.

are active can be

D Topic Notes and Tasks

Locate the following components on the Analyzer.

GETTING TO KNOW YOUR INSTRUMENT ANALYZER

If the tube holder door is closed, click

Each type tube/vial has an assigned slot in a tube holder. a)

GETTING TO KNOW YOUR INSTRUMENT ANALYZER

GETTING TO KNOW YOUR INSTRUMENT ANALYZER

GETTING TO KNOW YOUR INSTRUMENT ANALYZER

GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE

REAGENTS AND INSTRUMENT WASTE

GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE

D Topic Notes and Tasks

Reagent ACT 5diff Diluent

ACT 5diff Hgb Lyse

ACT 5diff WBC Lyse Yellow

Same as shelf life (date printed on the container)*

GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE

Reagent ACT 5diff Fix

Label Color Green

ACT 5diff Rinse

Same as shelf life (date printed on the container)*

When changing a reagent: a.

From the Main Menu screen, click

GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE

GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE

To view the selection, from the Main Menu click

If the waste is hooked up to a container: a. b. c. d. e.

GETTING TO KNOW YOUR INSTRUMENT REAGENTS AND INSTRUMENT WASTE

D Topic Notes and Tasks

The Startup cycle is a sequence of Analyzer cycles that: a. b. c.

STARTUP / SHUTDOWN STARTUP PROCEDURE