HumaLyzer 3000 User PDF

HumaLyzer 3000
| User Manual
|
Cat.No. 16700/1
Revision List of the Manual
No. DATE / Rev. REVISION DESCRIPTION
1 03/2004-04 First edition
2 04/2008-09 Reformat
3 05/2008-11 Correction of small typing errors
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1 INTRODUCTION
This manual is considered as a part of the instrument; it has to be at the operators hand as well as at the
maintenance operators availability. For accurate installation, use and maintenance, please read the following
instructions carefully. In order to avoid instrument or personal damages, carefully read the GENERAL SAFETY
WARNINGS, describing the suitable operating procedures. In case of breakdowns or any troubles with the
instrument, apply to the local Technical Service.
2 USER WARRANTY
HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in
material or workmanship, provided that this warranty shall apply only to defects which become apparent within
one year from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item at no charge, except for transportation
expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in
the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in
accordance with the manufacturer's instructions, altered in any way not specified by HUMAN, not regularly
maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed.
HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty
registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported
to the freight carrier for settlement or claim.
3 INTENDED USE OF THE INSTRUMENT [IVD]

The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as described in this manual, according to the
GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators.
4 GENERAL SAFETY WARNINGS

Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in this manual.
Place the product so that it has proper ventilation.
The instrument should be installed on a stationary flat working surface, free from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to the specifications listed in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conductor of the power cord connected to
earth ground.
Use only the fuse type and rating specified by the manufacturer for this instrument, use of fuses with improper
ratings may pose electrical and fire hazards.
To avoid fire or shock hazard, observe all ratings and markings on the instrument.
Do not power the instrument in potentially explosive environment or at risk of fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may become damaged.
It is recommended always to wear protective apparel and eye protection while using this instrument.
Respective warning symbols, if appearing in this manual, should be carefully considered.
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5 DISPOSAL MANAGEMENT CONCEPT
The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to
arrange proper disposal of the individual components.
All parts which may comprise potentially infectious materials have to be disinfected by suitable validated
procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be
carefully observed.
The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to
the regulations for the disposal of electronic components.
Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed
off in accordance with applicable local regulations.
6 INSTRUMENT DISINFECTION
Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be
considered at least potentially infectious. Therefore every part and accessory of the respective instrument which
may have come into contact with such samples must equally be considered as potentially infectious.
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be
decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained
personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a
disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not
supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument
by the servicing centre, or from authoritys interventions.
7 NOTICE
Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve
products as new techniques and components become available. HUMAN GmbH therefore has to reserve the right
to change specifications if necessary in the course of such improvements.
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NOTICE
Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls
which should be considered at least potentially infectious. Therefore every part and accessory of the respective
instrument which may have come into contact with such samples must equally be considered as potentially
infectious.
BIOHAZARD
The BIOHAZARD warning label must be affixed to instrument prior to first use with biological material !
Servicing Note:
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety
precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by
the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will
be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from
authoritys interventions.
HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 65205 Wiesbaden Germany
| Tel.: +49 61 22/99 88-0 Fax: +49 61 22/99 88-100
| e-Mail: tech-support@human.de www.human.de
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Contents
1 INTRODUCTION 5
2 OPERATING PROCEDURES 14
3 CLEANING AND MAINTENANCE 38
4 TROUBLESHOOTING 44
5 CONTACT INFORMATION 46
2/2
Contents
1 INTRODUCTION 5
1.1 Applications 5
1.1.1 Intended Use 5
1.1.2 Summary of the Instrument 5
1.2 Specifications 5
1.3 Warning Markings 7
1.3.1 Safety Symbols 7
1.3.2 Safety Terms 7
1.4 Safety Precautions 7
1.5 Setup 9
1.5.1 Unpacking 9
1.5.2 Installation/Preparation 9
1.5.3 Keypad Description 11
1.6 Checkout 11
1.7 Getting Started 12
1.7.1 Set Date/Time and Laboratory Name 12
1.7.2 Printer Set Up 13
2 OPERATING PROCEDURES 14
2.1 General Selections 14
2.1.1 Flowcell Configuration 14
2.1.2 Lamp Warm-up and Lamp Saver 15
2.1.3 External Ports 15
2.1.4 Serial Port 15
2.1.5 PC Connection 16
2.1.6 Error Messages While Using the Parallel or Serial Ports 16
2.1.7 Units of Measurement 16
2.1.8 Entering Names 17
2.1.9 Ranges and Controls 17
2.1.10 Reports 20
2.1.11 Blanking 21
2.1.12 Reading Samples 21
2.1.13 Bichromatic Operation (Differential Filter) 22
2.2 Calculation Programs 22
2.2.1 Absorbance Mode 22
2.2.2 Single Standard Mode 23
2.2.3 Factor Mode 25
2.2.4 Multi-point Mode 25
2.2.5 Rate Mode 27
2.3 Stored Tests 31
2.3.1 Recalling a stored test 32
2.3.2 Listing stored tests 32
2.3.3 Deleting a test 32
2.3.4 Editing a test 32
2.3.5 Using WORKLIST 33
2.4 Special Features 33
2.4.1 Self-Check 33
2.4.2 Flags and Error Messages 34
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1 INTRODUCTION
1.1 Applications
1.1.1 Intended Use
This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well
as any other application requiring absorbance or concentration readings at or near the available wave-lengths. This
general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate
features and options for each specific clinical application.
1.1.2 Summary of the Instrument
HUMALYZER 3000 is designed for the investigation of Biochemistry Enzyme Immuno and Drug Levels from human
serum, plasma, or urine. A removable Flowcell installs in the read well to provide extremely rapid fluid sampling
with low carryover. A built-in vacuum pump and an external waste bottle with level sensing are sup-plied standard.
When the Flowcell is removed, the instrument accepts standard 12 mm round tubes as well as 1 cm square
cuvettes.
The design of the instrument includes many features to minimise operator error, such as stable factory calibration,
automatic zeroing, complete operator prompting, detailed labelling, pre-programmed calculations, visual and
audible feedback, flags and error messages, and minimal maintenance requirements. The operating modes are:
Absorbance Mode
The HUMALYZER 3000 reads monochromatic or bichromatic differential absorbances at user-selected wave-
lengths.
Standard Mode
Reports concentrations based on a single standard concentration.
Rate Mode
Reports concentrations either based on the average absorbance per minute multiplied by a user supplied factor
(Rate by Factor), or based on the absorbance per minute of a standard (Rate by Standard). A fixed-time kinetic
mode calculates based on absorbance over a specified interval. The Rate Mode includes a Batch option that
permits kinetic assays to be run simultaneously.
Factor Mode
Reports concentrations by multiplying absorbances by a specified factor.
Multi-point Mode
Reports concentrations or percent absorbances based on the point-to-point connection of up to seven user-entered
standards.
In the Factor and Standard modes, differential samples (against sample blanks) are supported. Test parameters,
and standard curves are stored in memory for later recall. The HumaLyzer 3000 stores up to 120 tests in memory to
be recalled for later use. In addition, it will store 512 Patient Results, 512 Control Results, 20 Patients on Worklist,
and 15 tests per patient.
1.2 Specifications
Specification Date 22 May 2003
Model Name HumaLyzer 3000
Spectrophotometer Type Filter photometer
Optical Configuration Single beam with continuously rotating filter wheel
Monochromatic or bichromatic reading
8 filter positions
Usable Spectral Range 330 to 670 nm
System Procedures Open and by stored menu
Calculating Modes Absorbance
Single Standard
Differential samples
Factor Mode
Differential samples
Multi Standard Mode (up to 7 standards)
Multi Standard % Abs (up to 7 standards)
Kinetic Mode (consecutively, or simultaneously (Batch))
By Factor or by Standard
5 Human HumaLyzer 3000 User Manual

Fixed Time Kinetic
By Factor or by Standard
Channels 44 Pre-Configured, 76 Open
Source of Radiation Tungsten Halogen, 10 Watt, with automatic lamp saver
Selection of Wavelength By filter
Filter Type 4-cavity interference, long-life ion beam-assisted deposition
Wavelength Accuracy +/- 3 nm
Filter Location After sample (heat absorbing filter before sample)
Filter Selection Automatic by software or via keyboard
Wavelengths 340, 405, 505, 545, 580, 630 nm supplied standard
other/additional filters optional
Half Bandwidth < 10 nm
1/100 Bandwidth 14 nm at 340 nm
False Radiant Energy Ratio < 0.001 at 340 and 405 nm
Cuvette 1 cm square, 12 cm round, flow through
Supplied Type Flow-through
Material 316 stainless, borosilicate windows
Geometry Cylindrical, 2.3 mm dia x 5 mm +/- 0.05 mm
Illuminated Volume 21 l
Minimum Read Volume 250 l
Aspiration/Purge Vacuum pump at 18 cm of Hg
Valve Silicone pinch type
Cuvette Holder Thermostatically controlled compartment at 37 C
Detector Gallium-Arsenide-Phosphide photodiode
Signal Processing and Display
Display Type 240x128 Graphic LCD w/ Backlight
Scale of Display
Absorbance -0.5 to 3.5 (flow-through mode)
-0.5 to 2.5 (tube or 1 cm cuvette)
Concentration Maximum 999,999
Kinetic Results Abs/min with resolution of 0.0002 A/min
Zero Compensation Automatic
Range -0.5 to 2.5 absorbance
Signal Outputs
Parallel Centronics/IBM-PC compatible
Serial RS-232 at 9600 baud, 8 data, 1 stop,
no parity Bi-Directional
Data Input 1) 20 Key Keypad,
2) PS2 101 Keyboard (connector available at back of instrument)
Spectrophotometric Inaccuracy
Flow-through < 0.5 % at 1 absorbance, 340/630 nm NADH solution
< 1% at 2 absorbance, 340/630 nm NADH solution
< 3 % at 3 absorbance, 340/630 nm NADH solution
< 0.5 % at 1 absorbance, 405/630 nm PNP solution
< 1 % at 2 absorbance, 405/630 nm PNP solution
< 3 % at 3 absorbance, 405/630 nm PNP solution
Stability Better than 0.003 A/hr monochromatic after warm-up
Better than 0.001 A/hr bichromatic after warm-up
Warmup Time 90 seconds photometric
15 minutes for temperature compartment
Electronics Z180 Microprocessor 18 MHz
128k eeprom
32 K bytes Nonvolatile RAM (NVRAM)
Power Auto-Switching Power Supply
Voltage source: 100 - 240 VAC Frequency: 50/60 Hz
Power consumption: 90 watts
Installation Category: CAT II
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Fuses:
PS-25-5 Power Supply:
2.5A/250V Fast 5-20 mm (glass)
LPT 45 Power Supply:
2.5A/250V Fast 5-20 mm (ceramic)
Main AC Supply:
6/10 250V Slow Blow 3AG
Dimensions and Weight 43cm (L) x 39cm (W) x 15cm (H) Lid closed, (32cm Lid opened),
7.5 kg
Space Requirements 10 cm clearance on all sides
Environmental Conditions for

Safe Operation: Indoor Use. Temperature 5C to 40C. (Although it may be safe to
operate in these conditions, it may not be suitable for the
performance of the users tests. Check with supplier.) Humidity 85%
for temperatures up to 31C decreasing linearly to 50% humidity at
40C. Mains supply voltage fluctuations not to exceed 10% of the
nominal voltage.
Recommended Operating Temperature 15-35C
Recommended Operating Humidity Between 10 and 85%, non-condensing
1.3 Warning Markings

1.3.1 Safety Symbols
Safety symbols which may appear on the product:
WARNING Protective Ground CAUTION BIOHAZARD

Risk of Shock (Earth) Terminal Refer to Manual Risk of infection
FUSE: For continued protection against the risk of fire, replace only with fuse of the specified type and current
ratings. Disconnect equipment from supply before replacing fuse.
1.3.2 Safety Terms

These terms may appear on the product:
DANGER indicates an injury immediately accessible as this marking is read.
WARNING indicates an injury hazard not immediately accessible as this marking is read.
CAUTION indicates a hazard to property including the product.
Terms which may appear in this manual:

WARNING: Warning statements identify conditions or practices that could result in injury or loss of life.
WARNING indicates an injury hazard not immediately accessible as this marking is read.
CAUTION: Caution statements identify conditions or practices that could result in damage to this product or other
property.
BIOHAZARD: Biohazards are biological agents that can cause disease in humans. Lab workers handling potentially
infectious materials must use universal precautions to reduce the risk of exposure to these agents.
1.4 Safety Precautions

To assure operator safety and prolong the life of the instrument, carefully follow all instructions outlined below.
Read Instructions
Review the following safety precautions to avoid injury and prevent damage to this instrument or any products
connected to it. To avoid potential hazards, use this instrument only as specified. For best results, become familiar

with the instrument and its capabilities before attempting any clinical diagnostic tests. Refer any questions to your
instrument service provider.
Servicing
There are no user-serviceable parts inside the instrument. Refer servicing to qualified service personnel. Use only
factory authorised parts. Failure to do so may void the warranty.
Personal Protective Equipment
Many diagnostic assays utilise materials which are potentially biohazardous. Always wear protective apparel and
eye protection while using this instrument.
Follow Operating Instructions
Do not use the instrument in a manner not specified by the manual or the protection provided by the instrument
may be impaired.
Use Proper Power Cord
Use only the power cord specified for this product and certified for the country of use.
Ground the Product
This product is grounded through the grounding conductor of the power cord. To avoid electric shock, the
grounding conductor must be connected to earth ground. An alternate method is to attach a ground strap from the
external grounding terminal on the rear panel of the instrument to a suitable ground such as to a grounded pipe or
some metal surface to earth ground.
Observe All Terminal Ratings
To avoid fire or shock hazard, observe all ratings and markings on the instrument. Consult this manual for further
ratings information before making connections to the instrument.
Install as Directed
The HumaLyzer 3000 should be installed on a stationary flat working surface capable of supporting the
instruments weight (10 kg) safely for safety and ventilation purposes. The mounting surface should be at least
61 cm deep and free of vibrations.
Provide Proper Ventilation
Refer to the installation instructions for details on installing the product so it has proper ventilation. The
instrument should be surrounded by the following clearances: 10 cm around perimeter of unit and 10 cm on top.
Do Not Operate Without Covers
Do not operate this instrument with covers and panels removed.
Use Proper Fuse
Use only the fuse type and rating specified by the manufacturer for this instrument. Use of a fuse with an improper
rating may pose a fire hazard.
Avoid Exposed Circuitry
Do not touch exposed connections and components when power is present.
Avoid Excessive Dust
Do not operate in an area with excessive dust.
Do Not Operate With Suspected Failures
If damage is suspected to this instrument, have it inspected by a qualified service person.
Do Not Operate in Wet/Damp Conditions.
Do Not Operate In An Explosive Atmosphere.
Keep Instrument Surfaces Clean and Dry
Solvents such as acetone or thinner will damage the instrument. Do not use solvents to clean the unit. Avoid
abrasive cleaners; the display overlay is liquid-resistant, but is easily scratched.
The exterior of the instrument may be cleaned with a soft cloth using plain water. If needed, a mild all-purpose or
nonabrasive cleaner may be used. A 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) or 70% isopropyl
alcohol may be used as a disinfectant. Take special care not to spill liquid inside the instrument.
Operating Precautions
Be sure to run a sufficient number of controls in each assay. If controls are not within their acceptable limits,
disregard test results.
Biohazard Precautions
BIOHAZARD
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WARNING: If the Waste bottle is overturned during operation, immediately set the power switch to OFF (0). If this
occurs, the instrument may discharge a small amount of waste material from the waste bottle via the fitting on
the bottom of the instrument. This material should be treated as potentially biohazardous. Appropriate clean up
of the material should be observed.
1.5 Setup
1.5.1 Unpacking
Carefully unpack the instrument, removing it from its plastic bag. Report any damage to your freight carrier at
once. Retain the original packing material for future use in the event that the instrument is shipped to another
location or returned for service.
The following items should be packed with the instrument. Please locate each item now before continuing.
Included items Description

Heat Block External Incubation Block
Waste bottle Plastic bottle
Cleaning solution Plastic bottle containing Flowcell cleaning solution
Bottle cap assembly Bottle cap, tubes, sensor wires
Paper rolls (2) Thermal printer paper
Power cable Heavy cord
Serial cable RS232
Flowcell T-shaped object with square extension, in plastic box
Tool Kit and Spare tubing
Valve tubing Silicone tube
Sample tube, long Teflon tube, swaged end, for sample
Exit tube Teflon tube with male Luer attached
Tube gasket Foam rectangle with round hole
Tubing gripper Rectangle of emery paper
Hex wrench 1.6 mm
Operators Manual This document
Contact your distributor if anything is missing.
1.5.2 Installation/Preparation
Complete this procedure to prepare the instrument for operation.
Instrument placement and Use - Place the instrument on a flat working surface capable of safely supporting the
weight of the instrument, approximately 10 kg (22 lbs.). A clearance of at least 10 cm (4) around the instrument is
required to assure optimal ventilation.
If there is a label indicating that the valve tubing must be placed into the valve prior to operation, open the cover of
the instrument (see the section Opening the Instrument under Cleaning and Maintenance: Maintenance).
Install the loose valve tubing into the valve. Figures 6 A & B (located in the section Valve tubing replacement)
shows a diagram of the valve tubing location. Replace the cover and continue.
Place the waste bottle on the work surface behind the instrument. Position the waste bottle so that the tubing and
sensor lead are not kinked, twisted, or strained. Do not place undue stress on the tubing connections or sensor lead
connector. Tighten the bottle cap firmly.
Connect the waste bottle tubes to the rear panel fittings. The tubing connections are colour-coded; match the male
Luer cap to the colour-coded ring on the rear panel. The vacuum line fittings are blue and the waste line fittings are
black. Turn the fittings clockwise only until finger-tight. Do not over-tighten.
Plug the sensor lead into the sensor jack on the rear panel.
Place the bottle into the harness provided for it on the rear of the unit. Pull the strap so that the bottle is held
tightly then press it together so that the Velcro seals.
Power Switch Position - When installing the power cord the unit should be turned off. Look at the rear panel of the
instrument to check that the power switch is in the OFF (O) position.
Power Cord Requirements - Connect the supplied power cable to the rear of the instrument as shown. Plug the
other end of the power cable into an AC outlet. Use only the power cord specified for this product and certified for
the country of use.
For 110-120 V units used in the US, use a UL listed cord set consisting of a minimum 18 AWG, Type SVT or SJT three
conductor cord, maximum 3 meters (10 feet) in length, rated 10 A, 125 V, with a parallel blade, grounding type
attachment plug.

For 220-240 V units used inside the US, use a UL listed cord as above, except rated 250 V, with a tandem blade, with
grounding type attachment plug. The cord set provided by the manufacturer meets these requirements.
For other locations, use the power cord certified for the country of use.
Safety Grounding - Do not alter or defeat the safety grounding methods provided. To avoid the risk of electric
shock, the third prong of the AC power plug must be connected to conductive parts internal to the equipment.
Internal fasteners to grounding points are marked by the IEC 417 symbol 5019. DO NOT loosen or remove these
fasteners or connections. An alternate method of grounding is provided by connecting the grounding terminal
located on the rear panel to a suitable ground.
To avoid electric shock, the power cord protection ground conductor must be connected to ground.
Assure Clean Power Availability - The circuit used should be substantially free of large voltage transients (Kilo-volt
amp loads) such as large pumps, large centrifuges, refrigerators and freezers, air conditioners, large auto-claves,
ovens, and dryers. The instrument may fail to operate normally if the power supply is interrupted. If this occurs,
turn the instrument off for a moment. When the instrument is turned back on, it will resume normal operation,
but data that was not stored in nonvolatile memory will be lost.
Fuse Requirements - The fuses are located inside the instrument; there is a fuse in both power supplies and one in
the Main AC Supply. Fuse failure is a very rare occurrence and should indicate malfunction of the equipment
requiring service by qualified personnel.
The power supply mounted on top requires a 2.5A/250V Fast 5-20 mm Glass Fuse. The power supply mounted to
the chassis requires a 2.0A/250V Fast 5-20 mm Ceramic Fuse. The Main AC Supply requires a 6/10 250V Slow Blow
3AG Fuse
WARNING: For continued protection against risk of fire, always use the specified fuse for replacement. Disconnect
power cord from mains supply before replacing fuses.
Inserting the Flowcell: Note: Use extreme caution as forcing the Flowcell to seat improperly may dam-age it or the
instrument. Insert the Flowcell in the read well so that the sample tube is toward the front. Press the Flowcell
gently down and towards the rear into the read well. Verify that the Flowcell is seated firmly.
Set the power switch at the right rear of the instrument to ON (1). The display shows:
Heat Block
Cell Temp. Ext. Keyboard Lamp Flowcell Vacuum Pressure
Temp.
Heating
Lab Name
(User
Specified)
Note: The External Keyboard icon will appear only after a key on the external keyboard has been pressed. The
printer will print several lines. Wait until it has stopped. (If there is no printing, the internal printer is disabled. Refer
to Printer Set-Up 1.7.2 in this manual.)
To load paper: Locate the roll of printer paper. Roll out 15 cm (6) of paper from the roll. Be sure that the leading
edge of the paper is straight. Cut the edge of the paper straight across with scissors if necessary. Feed the leading
edge of the paper into the slot inside the printer paper compartment. While feeding the paper as de-scribed, press
the PAPER key repeatedly until the paper catches and begins to feed into the printer. When the printer paper
exits at the top of the printer, stop pressing the PAPER key. The paper may be pulled through to help with
alignment. Place the paper roll into the printer well.
Using the Flowcell: To aspirate using the Flowcell, activate the Sample Sensor. The Sample Sensor is the square
hole directly below the Flowcell. This is activated by interrupting the beam with a finger, pencil, or other object.
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Clean the Flowcell: Press the TOOLS (F4) key. Select 2 in the corresponding menu to enable Flowcell. Locate the
bottle of Flowcell cleaning solution. Open the bottle and position it so that the sample tube is immersed in the
solution. Activate the Sample Sensor to aspirate cleaning solution into the Flowcell. Remove the bottle of cleaning
solution and replace the cap. Allow the solution to remain in the Flowcell for 3 minutes.
Position a container of distilled water so that the sample tube remains immersed. Activate the Sample Sensor to
aspirate water into the flow cell. (The flow cell activates using an optical sensor in the notched out are behind the
aspiration tube.) Allow the water to remain in the Flowcell for 3 minutes.
Purge: Activate the Sample Sensor and continue with the interruption of the beam until no more liquid can be seen
flowing into the waste bottle. (During sampling, the instrument will purge automatically between samples.)
Set the power switch to OFF (O) and continue to the section Checkout.
1.5.3 Keypad Description

Refer to Figure 1, Keypad Layout. The Function keys (F1 through F4) correspond to the four keys shown at the
bottom of the screen in the same order. For example, in the opening screen, F1 = Run Test, F2 = Program,
F3 = Worklist, F4 = Tools.
When applicable, the Enter key on the main keypad performs the same function as the Enter Function key shown
on the screen.
Lamp: Toggles the lamp on or off.
Line Feed: Internal Printer, feeds one line at a time; External Printer, skips one line.
Form Feed: External Printer, initiates the printer to print all data stored in its internal memory.
Figure 1. Keypad Layout
1.6 Checkout
Follow this procedure to verify that the instrument is ready for use.
In this procedure, it is assumed that the Flowcell is being used. If using the instrument with tubes or square cu-
vettes, disregard the Flowcell information.
Visually confirm the following items:
Waste bottle is connected to the correct fittings.
Sensor lead is plugged in.
Waste bottle is empty.
Waste bottle cap is tight.
Power cable is plugged into rear of unit and into AC outlet.
Flowcell is fully seated in read well and Luer fitting is connected (if Flowcell is in use.)
Heat Block is connected.
External Keyboard is connected. (If applicable)
Power switch is set to OFF (O).

The instrument is now ready for power-up. Confirm that the instrument responds as described.
Set the power switch at the right rear of the instrument to ON (1).
The display will show:
The printer will print a header containing the instrument model, software revision, laboratory name, and the date
and time. (If the Flowcell is disabled, V = #.# on the status line would read Tube.)
HumaLyzer 3000 v. A
DD/MM/YY HH:MM
The letters following v. indicate the software revision. If the date and time are incorrect, set the date and time as
described in section 1.7.1 Set Date/Time. Allow the instrument to equilibrate for at least 15 minutes. The read
well must be at 37C. See section 2.1.3.
If the instrument produces results other than those described here, set the power switch to OFF (O). Refer to the
section entitled Setup and review all steps carefully. Repeat the Checkout procedure. If the instrument still pro-
duces results other than those described here, refer to the section entitled Troubleshooting, or contact your
dealer for assistance.
1.7 Getting Started

1.7.1 Set Date/Time and Laboratory Name
Press the F4 Key (Tools). The display shows the following options:
1 = Stored Data Utilities:
This is where the User Test Data Menu, the Control Data Menu, and the Patient Result Data Menu are located.
2 = Flowcell Configuration:
Turn Flowcell Off to use Tubes or cuvettes, On if using Flowcell.
3 = Printer Setup:
This allows the user to set up either the internal or external printer.
4 = Diagnostics Menu:
This is where the Filter Voltages, Filter Wheel Speed, Absorbance Calibration, Temperature Calibration, and Current
Vac, Temp, Waste Count are found. Also a Self Check, shown below (see Sec. 2.4.1):
5 = General Configuration:
This is where the operator will set User Specific Options.
Press 5. The next screen offers four options. Set Date and Time, Enter Laboratory Name, Delete Laboratory
Name, Cell Heat Control, or Block Heat Control.
1 = Set Date and Time:

This screen will ask to choose a Date Format. Choose 0 for MM/DD/YY or 1 for DD.MM.YY (Eurodate format), and
press Enter.
Note: If using a Chinese instrument, the date is fixed YY.MM.DD
Enter the Date as month, day, and year (or day, month, year in Eurodate format) using two digits each and sepa-
rating the entries with the decimal point, then press Enter. Enter the time as hour, minute, and seconds using two
12
digits each and separating the entries with the decimal point, then press Enter. Use 13 for 1 PM, 14 for 2PM,
etc.
2 = Enter Laboratory Name:
To enter the Laboratory Name, see section 2.1.8 Entering Names in this manual.
3 = Delete Laboratory Name:
Press 3 and the Laboratory Name is deleted and the user is returned to the TOOLS menu.
4 = Cell Heat Control:
Press 0 and Enter to turn the Heat Cell Off, 1 to turn it On. The temperature of the read well is displayed at the
top of the screen continuously no matter what mode the instrument is in. The temperature of the cell is
automatically controlled to 37C by the software.
5 = Block Heat Control:
Press 0 and Enter to turn the Heat Cell Off, 1 to turn it On.
Allow at least 15 minutes for the instrument to equilibrate after enabling or disabling cell or block temperature
control. When installing a room-temperature cuvette or the flowcell to an instrument that has already reached
temperature equilibration (about 15 minutes from power-on), allow at least 5 minutes for the cuvette or the flow-
cell to equilibrate after insertion.
Note: Even with temperature control disabled, the ambient temperature of the cell is somewhat higher than room
temperature.
1.7.2 Printer Set Up

The instrument has a built-in 40 column thermal graphics printer that is used to list information and provide a
record of the samples. There are two ports, a parallel and a serial port on the rear of the instrument that commu-
nicate the same information that is sent to the internal printer. Select either, both or neither of the printers or
ports. The data is output to both printers or ports in the same format. When connecting an additional printer or an
external PC, the instrument must be switched off. After the connection is made, turn the instrument on again.
Enable the EXTERNAL Printer. This will also enable the serial port. To advance the paper or send a line feed, press
Line Feed. The line feed advances. Press F4 (Tools). At the Instrument Tools screen, select 3 Printer Setup.
Choose the Printer type. To select the HumaLyzer 3000s Internal Printer, select 1. If using an External Printer or
serial port, select 2. The third selection is 3 - Internal Printer Font Sample. This prints a list of characters in both
draft and letter in the five available contrast settings on the internal printer.
1 - Internal: The display shows:
Internal Printer Status (F1): The current status is highlighted. Press F1 (STATUS) to toggle to the desired status.
Internal Printer Contrast (F2): The current contrast setting is highlighted. To move to the desired setting, press F2
(CONTRAST). Keep in mind that the lighter settings print faster.
Internal Print Quality (F3): The current quality setting is highlighted. Letter is a higher quality print, but much
slower on print time. Press F3 (QUALITY) to toggle between the two selections. Once these selections are made,
press COMPLETE (F4) to return to the instrument tools page.

External: The display shows:
External Printer Status: Shows current status. Use F1 (STATUS) to toggle to chosen Status.
Current Maximum Lines per Page: Shows current number. To change this number, Press F2 (LINES/PG) and enter
the number. Press Complete to return to the instrument tools menu.
2 OPERATING PROCEDURES
2.1 General Selections
2.1.1 Flowcell Configuration
Flowcell Configuration offers 2 choices; read tubes and cuvettes, or activate the Flowcell with options to change
the aspirate (sample) volume, and read and store water reference values. From the Main Menu, press F4 (TOOLS).
Then press 2, Flowcell Configuration, Enter. The display shows:
Press F1 (STATUS) to change Flowcell status, in this case to On. The Flowcell immediately turns on and ON is
highlighted. To change the volume sampled, select F2 (VOLUME). The display shows:
Choose the number which corresponds with the desired volume. For instance, type 0 for the volume 750, then
Enter. The display shows the Flowcell configuration menu. The Current Sample Volume reflects the chosen volume.
14
To Calibrate the Flowcell, press F3 (CAL MENU). The display shows:
Note: These options may only be used if the Flowcell is active.
1=Read Water Reference: The instrument references water instead of air when reading with the Flowcell. These
reference values are stored in non-volatile memory and are used whenever the Flowcell is active, until new values
are read. This should be done before Flowcell Alignment.
2=Flowcell Alignment: Choosing 2 and Enter shows the Flowcell Alignment Screen. First, the Flowcell should be
active but NOT inserted into the read well. Press F3 (PRINT) to print the current reading. Insert the Flowcell into the
read well. Submerge the end of the tubing into a container of water and activate the Sample Sensor. The sample
sensor should be held until water starts to flow into the Waste Bottle. This will decrease the likelihood of air
bubbles interfering with an accurate reading. This reading should be slightly over half of the original reading. If it is
not, the Flowcell must be adjusted.
If the displayed value is less than 50% of the reading with the Flowcell removed, purge and remove the Flowcell.
Adjust the set screw with the hex wrench supplied. Turn the set screw 1/4 turn in either direction and replace the
Flowcell. Sample water again. If the value increases, turn the set screw in the same direction. If the value de-
creases, turn the setscrew in the opposite direction.
Repeat until the value is >50%. When complete, press ENTER to return to the previous prompt. New water values
must be read as described above in Read Water Reference.
2.1.2 Lamp Warm-up and Lamp Saver

The lamp must warm up before any readings can be taken. As soon as the lamp is turned on the warm-up time
begins and continues to count down. If a test is selected very quickly, the instrument will pause until the warm-up
time has elapsed. The message Lamp Warm-up:XX Secs is displayed and the time XX will count down to zero. When
the warm-up is complete the instrument will proceed.
If the instrument has not been used in approximately 15 minutes, the lamp will automatically be turned off to
extend the service life of the lamp. Select a test or mode, or press LAMP to turn the lamp on.
2.1.3 External Ports

An external printer may be connected to the parallel port on the rear of the unit. Any IBM compatible printer and
standard parallel cable may be used with the parallel port. The serial port on the HumaLyzer 3000 is Multi-
Directional (transmits and receives data). The receiving device may momentarily stop the transmission from the
instrument. It will resume automatically when the receiving device is ready. If the receiving device does not have a
large enough buffer, the HumaLyzer 3000 times out and the Ext Printer Not Ready, Retry Y/N? error message
appears on the display. This error message refers to any receiving device (printer, PC, external serial or parallel
ports).
2.1.4 Serial Port

By using a standard RS232 Cable (Null Modem Serial Cable), a computer with a serial port may be connected. The
data format is 9600 baud, 8 bits, 1 stop bit, and no parity. Contact your distributor to obtain a serial printer cable.

2.1.5 PC Connection
The serial port pinout has been reconfigured to allow direct connection to a PC. The output may be viewed on a PC
by using a program such as HyperTerminal once the communications protocol in the program has been set to the
HumaLyzer 3000 data format.
3 TD (TRANSMIT DATA output)
5 GND (SIGNAL GROUND)
8 CTS (CLEAR TO SEND input)
SEE 2.1.6 for more Info.
2.1.6 Error Messages While Using the Parallel or Serial Ports

If the external printer or PC is enabled, and the printer or PC is connected but is off-line, an error results only when
the instrument attempts to communicate when in a mode. The instrument stops and displays serial receiver not
ready until the problem is corrected.
In the event that the external printer or PC buffer becomes full (i.e. the instrument has sent as much data as the
printers memory can hold), the instruments display will prompt to Retry. Press YES to continue to output after
the printer or PC has emptied its buffer, or NO to turn off communication to external ports.
2.1.7 Units of Measurement

In all modes except Absorbance Mode, the option of selecting units of measurement is given. Units are provided to
label the calculated concentrations, but have no bearing on the actual calculation. The display shows:
Press MORE (F2) to see the rest of the choices:
Press the numeric key that corresponds to the choice and ENTER. The units for that code are displayed. To confirm
the choice press YES. To select a different unit, press NO and a different numeric key.
16
2.1.8 Entering Names
It is sometimes necessary to enter an alphanumeric name. For instance, user tests and controls can be named, and
the laboratory name shown in the header may be changed. When prompted for a name, the following display is
shown if no external keyboard is connected:
The cursor is the small triangle beneath the A on the top line. Press 4 to move the cursor to the left, 6 to move the
cursor to the right, 2 for up, or 8 for down. When the cursor is beneath the first letter of the chosen name, press
SELECT. The bottom line clears and shows the selected letter. Continue using the 2, 8, 4 and 6 keys and SELECT to
select each letter in the name. When complete, press COMPLETE. To remove a letter from the end of the name,
press F2 (Back Sp.). To cancel and return to the main prompt, press QUIT.
The HumaLyzer 3000 offers the option of using an External Keyboard. If it is plugged in before turning instrument
On, the External Keyboard is automatically activated by pressing any key. If the External Keyboard is active, each
time the instrument prompts the user to Enter Name, the External Keyboard alone will be used and the KeyPad
screen (shown in this section) will not appear. The External Keyboards key usage limitations are listed as follows:
Any letter or number key are available for data entry.
The F1 - F4 keys work the same way that the F1 thru F4 keys work on the keypad.
The Shift or CAPS LOCK keys can be used to change the case of the characters.
Windows Specific keys have no function. (i.e. Ctrl, Alt, Tab, Esc, etc.)
2.1.9 Ranges and Controls

In all modes except Absorbance Mode, the user has the option of entering ranges and / or controls. The display will
show:

Press 1 (Set Up Ranges). The display shows:
If applicable, enter the Blank Abs. Min and Max values. In this example, those values were skipped (Any value can
be skipped by simply pressing ENTER). Enter the concentration limits for the Normal Range and Linear Range.
The display will show:
The user may also change any of the values by using the CLEAR (F3) key or the ARROW (F2) Key. When the
instrument takes a reading, a word indicating the range (none, LOW, HIGH, OUT) is shown to the right of the
concentration on both the display and the printer.
None: The concentration is within the normal range.
LOW: The concentration is lower than the Minimum value of the Normal range, but within the linear range.
HIGH: The concentration is higher than the Maximum value of the Normal range, but within the linear range.
OUT: The concentration is outside the Linear range.
If finished, press ENTER when COMPLETE is highlighted.
The user is returned to the Results Parameters Setup Menu. Press 2 to Setup controls. The instrument allows the
user to enter and name up to 3 controls per test. Controls are designated samples with specified concentration
ranges that provide a reference for comparisons. The display shows:
18
Select 1, 2 or 3 and Enter to choose the desired control type. A Normal control is used in this example. Select 1. The
display shows:
From this menu, if F1 (QUIT) is chosen, the instrument returns to the Main Menu and quits the test. Press F4
(Disable) and return to the Result Parameters Setup Menu. If F3 (ENABLE) is selected, the instrument prompts to
Enter Normal Control Name. (For more information, see section 2.1.8 Entering Names.) Once completed, the user
is prompted to Enter Normal Control Lot Number. Enter this number in the same way.
Once complete, the instrument prompts to Enter Normal Control Expiration Date: Using the keypad or key-board,
enter the expiration date in the MM.YY format. For instance, if the expiration date is September 2007 the user
will enter 09.07. When finished, press F4 (ENTER). The display will prompt you to enter a Low Range Limit.
Enter the Low Range and press Enter. Then input the High Range and press Enter. The display now shows:
The user should understand that in all selections except #4, passing control data is saved. Select the number which
corresponds with the reaction that should be taken in the event of a failed control and press Enter. The display will
return to the Control Selection menu. Select another control or press 4 to return to the Result Parameters Setup
Menu.
Control results can be saved and used later to generate a Levey-Jennings report. (See section 2.1.10 Reports for
more info.)
When finished, select 3, Setup Complete.

2.1.10 Reports
The instrument provides reports to the printer, internal and / or external, showing the stored patient data and
interpretations along with logged information such as the test name, date and time, and includes space for
laboratory information. Patient data is stored and retrieved by patient name, and there is room for a total of
512 results.
To print a report:
At the end of shift or reporting period, press QUIT so that the instrument displays the main prompt. Press F4
(TOOLS). Press 1. The display shows:
1 = Stored User Test Menu: Press 1 and the display shows:
Press 1 to Print a menu of all of your stored tests.

Press 2 to Delete all of your stored tests.
Press 3 to Delete one of your stored tests.
Press 4 to Edit one of your stored tests.
Press 5 to Download your tests from a connected PC. (See section 2.4.1 for info)
Press 6 to return to Stored Data Utilities Menu.
20
2 = Stored Controls Menu: Press 2 and the display shows:
Press 1: Enable/ Disable controls in your stored tests by selecting the test number.
Press 2: Deletes all stored control results.
Press 3: Deletes stored control results by test and lot #.
Press 4: Prints controls stored in a test by a chosen test #. It prints Test #, Control Data, Lot Number, Type Name,
and Result.
Press 5: Creates a Levey-Jennings Report using a selected test and control results.
Press 6: To return to Stored Data Utilities Menu.
3 = Stored Patient Result Menu. Press 3 and the display shows:
Press 1: Print a patient report by a Patient ID you select.

Press 2: Delete all of a patients results by ID.
Press 3: Delete all results for a selected test #.
Press 4: Delete ALL stored patient results.
Press 5 to return to Stored Data Utilities Menu.
Press F1 (QUIT) to return to the main menu.
2.1.11 Blanking
The instrument prompts to Read the blank each time a mode is selected or a test is recalled (optionally). Insert a
tube containing blank material, or sample the blank material using the flow cell. (See Reading Samples below.)
The absorbance of the blank will be printed with a B in place of the sample number. Note that in Rate Mode the
value of the blank is not printed. To re-blank the instrument without re-selecting the mode, press BLANK.
The blank absorbance that is printed is relative to air when in tube mode. In Flowcell mode, it is relative to the
stored water values. In this way the user can evaluate the suitability of the blank before using it. By pressing the
BLANK key, blanking can be done anytime and as many times as the user chooses.
2.1.12 Reading Samples

Using tubes or cuvettes:
The instrument prompts to Read the blank or Read sample. Insert the tube or cuvette into the read well. The
instrument takes the reading, and displays and prints the result. After the result is displayed, the tube may be
removed. The instrument prompts to insert the next tube.

Using the Flowcell:
The READY indicator on the front of the instrument will light and the display will prompt to Read the blank or
Read sample. Hold the container with the fluid to be sampled so that the sample tube is below the fluid surface.
Do not allow the sample tube to lie against the bottom of the container. Activate the sample sensor. The instru-
ment will automatically sample the pre-set amount. Remove the sample container from the sample tube after the
instrument beeps. When the reading is complete the sample will be automatically purged from the Flowcell and
drawn into the waste bottle at the rear of the instrument. When the instrument is ready for the next sample, the
READY indicator lights, and the instrument prompts to read the next sample.
2.1.13 Bichromatic Operation (Differential Filter)

The instrument allows the user to read bichromatically with no increase in read time. Use the instrument bichro-
matically whenever possible, especially in Rate Mode. The absorbance at the differential wavelength is subtracted
from the absorbance at the primary wavelength. Whenever possible, differential (bichromatic) reading is
recommended because precision is significantly improved by removing the effect of optical imperfections and non-
uniform wall thicknesses when using disposable plastic cuvettes or glass tubes. In order to preserve sensitivity, it is
important to choose a differential wavelength for which the chromophore being assayed exhibits minimal
absorbance.
Wavelength Chromophore
340 UV
405 purple
505 blue green
545 emerald green
580 yellow
630 red
To test your chromophore, read a darkly coloured solution in the absorbance mode at the operating wavelength
with no differential filter, and again at the operating wavelength with the differential filter selection. If the two ab-
sorbance readings are within 10% of each other, then bichromatic differential reading is beneficial. If the difference
between the absorbance readings with and without a differential wavelength is greater than 25%, then the
chromophore is absorbing at or near the differential wavelength and bichromatic reading at this wavelength is
probably not desirable.
If no bichromatic wavelength is selected, exercise every measure to enhance repeatability. Choose a better quality
reading vessel and wipe fingerprints from each tube before reading. Mark each tube for uniform orientation when
multiple readings are desired. Determine the acceptability of the precision by reading the same tube several times
and observing the variation of the readings. Depending on the precision requirements of your assay,
monochromatic reading may or may not be acceptable with certain plastic tubes.
Wipe any dust, moisture, or fingerprints from the tubes before using.
Do not read tubes that contain bubbles or condensation.
Use a blank material with absorbance of less than 0.400A.
Use the same type and size of tube for the blank and samples.
2.2 Calculation Programs

2.2.1 Absorbance Mode
In Absorbance Mode, the instrument reads and prints sample absorbances at selected wavelengths. The instru-
ment prints the date and time and the mode of operation.
Press PROGRAM (F2). Select 1 and ENTER.
The Select Filter Screen will be shown. PRIMARY FILTER is Highlighted
Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected
wavelength is highlighted.
DIFFERENTIAL FILTER is then Highlighted.
Select the differential wavelength or press 0 to read monochromatically and press ENTER. The Wavelengths are
then printed.
The next two options are first to save the test and then to name the test. If yes to saving the test, the option will
then be given to name the test. When a test is saved, it will always be saved as the next available number. 1, 2, 3, 4,
etc. After naming the test and pressing COMPLETE, display shows:
Saving Test #
22
Then gives the test number, then the name the user saved it as. If it is the first saved test and is named HIV, the
display and printout will show:
Saving Test # 1 HIV
If in tube mode, the instrument now makes an air reference reading. If Flowcell is active, it uses the stored reading.
The display then shows:
Insert the blank tube or sample the blank material. See the section 2.1.11 Blanking for details. When finished
reading, remove the tube or sample the material. Re-blanking may be done at any point by pressing BLANK.
The display shows:
Remove the sample and repeat as necessary. To exit Absorbance Mode and return to the main prompt, press QUIT
(F1). The instrument prints Test Ended and returns to the main prompt.
2.2.2 Single Standard Mode

In Single Standard Mode, the instrument reads and prints absorbances, and calculates concentrations based on a
standard material of known concentration. Results are calculated according to Beers Law. The calibration factor is
printed for future use.
Press PROGRAM (F2). Select 2. The display shows:

Standard Mode
Differential Samples?
Press YES to use differential samples. This works exactly as described below, except that each sample has its own
blank, rather than using the same blank for all subsequent samples. The instrument automatically prompts for the
blank preceding each sample. If not using differential samples, press NO to continue.
The Select Filter Screen will be shown. Primary Filter is Highlighted
Press the numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected
Differential Filter is then Highlighted. Select the differential wavelength in the same way the primary wavelength
was chosen and press ENTER. The Wavelengths are then printed.

The display shows:
Enter the value of the standard and press ENTER. To clear a mistake and re-enter the factor press CLEAR. The
standard concentration is then printed.
Note: The instrument will accept a factor which is up to seven digits, and there can be up to (2) decimal places.
The instrument then prompts for a unit of measure to be entered. Enter the units code (0-13) and press ENTER. See
the section 2.1.7 Units of Measurement for details. The entire list of Units is displayed. Type in the corresponding
number and press ENTER. The display then shows the selected unit. Press YES to accept.
The Result Parameters screen is then shown prompting the user to set up Ranges and Controls. See section 2.1.9
Ranges and Controls for more on this option.
etc. After naming the test and pressing COMPLETE, Display shows:
Saving Test #
Saving Test # 1 HIV
If the instrument is in tube mode, it displays Referencing Air and makes an air reference reading. In Flowcell
mode, the stored water values are used as a reference.
Insert the blank tube or sample the blank material. See the sections 2.1.14 Blanking and 2.1.15 Reading
Samples for details.
The display shows:
Insert the standard tube or sample the standard material. See the section 2.1.15 Reading Samples for details. The
instrument will read the absorbance and determine the factor such that the concentration of the standard is the
value that was specified. The Standard Reading calculated factor will be printed. Repeat as necessary.
Re-Blanking may be done at any point by pressing BLANK. To exit Standard Mode and return to the main prompt,
press QUIT. The printer outputs Test Ended, and the instrument returns to the main prompt.
24
2.2.3 Factor Mode
In Factor Mode, the instrument reads absorbances at the selected wavelengths, and calculates concentrations by
multiplying the absorbance by the user supplied factor.
Press PROGRAM (F2). Select 3. The display shows:
Factor Mode
Differential Samples?
Press YES to use differential samples. This works exactly as described below, except that each sample has its own
blank, rather than using the same blank for all subsequent samples. The instrument automatically prompts for the
blank preceding each sample. If not using differential samples, press NO to continue.
The Select Filter Screen will be shown. Primary Filter is highlighted. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press ENTER. The selected wavelength is highlighted.
was chosen and press ENTER. The Wavelengths are then printed.
Enter the Factor when prompted and press ENTER. To clear a mistake and re-enter the factor press CLEAR. When
ENTER is pressed, the factor is shown on the printer.
Note: The instrument will not accept a factor which is more than seven digits, and there can be up to (2) decimal
places.
Enter the units code (0-13) and press ENTER. See the section Units of Measurement for details. The entire list of
Units is displayed. Type in the corresponding number and press ENTER. The display then shows the selected unit.
Press YES to accept.
Saving Test #
Then gives the test number, then the name the user saved it as. If it is the first saved test and is named Test HIV,
the display and printout will show:
Saving Test # 1 TEST HIV
Read the sample Blank. Then continue with normal sampling following the prompts given by the instrument. See
the sections 2.1.14 Blanking and 2.1.15 Reading Samples for details.
To exit the mode and return to the main prompt, press QUIT. The printer outputs Test Ended, and the instrument
returns to the main prompt.
2.2.4 Multi-point Mode

In Multi-point mode, the instrument reads and prints absorbances, and calculates the concentration based on the
concentrations of the standards. Up to seven standards can be entered. The absorbances of the standard are used
to construct a point-to-point curve which passes through all of the standards and the point (0,0). Unknown
samples are calculated as follows: First, the unknown samples absorbance is calculated and compared to the
standard absorbances. The line segment of the standard curve used to determine the concentration of the un-
known is the line connecting the pair of standards whose absorbances are closest above and below the unknown
absorbance.
An unknown sample with absorbance greater than the highest standard absorbance is calculated on the line
passing through the highest 2 standard points. An unknown sample with absorbance less than the lowest standard
absorbance is calculated on the line passing through the lowest 2 standard points.
For samples requiring flowcell aspiration volumes of 350 l or less, the shorter sample tube (provided in the tubing
kit) must be installed. Refer to the section Flowcell tubing replacement.
Press F2 (PROGRAM) then 4. The display shows two choices. Press 1 and Enter to choose Standard Multi-Point
Mode, 2 and Enter for Multi-Point % Absorbance Mode. The Multi-point % Abs mode is similar in calculation to the
Multi-Point mode, except that the percent absorbance is calculated and printed, and the standards must be in
descending order.

Note:
In Multi-point mode, the standards should be in order from lightest to darkest.
In Multi-point % Abs mode, standards must be in order from darkest to lightest.
The Select Filter Screen will be shown. Primary Filter is Highlighted. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press ENTER. The selected wavelength is highlighted.
was chosen and press ENTER. You are then prompted to enter the number of Standards you will be using. Type in
the number of standards (1-7) and press ENTER.
The instrument prompts you to enter the value of each Standard. Type in the value, in units, of the standard and
press ENTER. To clear a mistake and re-enter the standard press CLEAR once. When ENTER is pressed, the value is
shown on the printer. Repeat this step for each standard.
The Enter Unit Code screen is shown. Enter the units code (0-13) and press ENTER. See the section Units of
Measurement for details. The entire list of Units is displayed. Type in the corresponding number and press ENTER.
The display then shows the selected unit. Press YES to accept.
Saving Test #
Saving Test # 1 HIV
If the instrument is in tube mode, it displays Referencing Air and makes an air reference reading. In Flowcell
mode, the stored water values are used as a reference.
Insert the blank tube or sample the blank material when prompted. See the sections 2.1.14 Blanking and 2.1.15
Reading Samples for details. The display shows:
The instrument prompts to read each of the standards in turn. Insert the standard tube or sample the standard
material. See the section 2.1.15 Reading Samples for details.
If any of the standards is less than the previous standard (greater than if using Multi-point % Abs Mode), it will be
marked with an X and the instrument will print
CURVE INVALID!-
Since this invalidates the results, the procedure must be repeated from the beginning.
The display shows the Standard curve on the graph and displays:
Press YES to plot the standard curve.
While the plot is being generated, the display shows:

Plotting...
The plot shows the absorbance along the vertical (y) axis, the concentration along the horizontal (x) axis, and the
standard numbers along the plotted line.
26
The display then prompts the user to read sample. Insert the tube or sample the material. The concentration will be
calculated as described above. Repeat this step as desired.
The user may re-blank at any time by pressing BLANK. To exit Multi-Point Mode and return to the main prompt,
press QUIT or F1. The printer outputs Test Ended, and the instrument returns to the main prompt.
2.2.5 Rate Mode

In Rate Mode, the instrument takes periodic readings of a sample at intervals. The user supplies the Lag time and
the Read time, both in seconds. Lag time is the length of time that the instrument pauses before it takes the first
reading, and is measured from the point at which the user inserts the tube or aspirates the sample. Read time is
the total length of time over which the reaction is monitored. The read time must be a multiple of 30 seconds. The
read interval is the interval at which the intermediate readings are taken and recorded, and is fixed at 30 seconds.
The A/min. or rate of the standard will be determined by a linear regression calculation covering the read interval.
This A/min. is printed beside S1 and is used to determine the rate factor.
A/min.
Concentration of Standard = Factor
Choose from three Calculation methods in Rate Mode.
Rate by Factor Enter a FACTOR which the instrument uses to calculate the concentration of the sample
at each reading.
Rate by Standard Supply a STANDARD material which the instrument reads and uses to calculate a factor
to obtain the concentration of each sample.
Fixed Time Kinetics Enter a FACTOR or supply a STANDARD material as described above, however, results
are based on total , not A/min.
In addition, Rate by Factor and Rate by Standard tests may be performed individually (consecutively) or in batch
mode (simultaneously).
Most rate reactions are temperature dependent. Make sure that the cell temperature control is enabled as de-
scribed in the section Temperature Control. Allow a minimum of 15 minutes for the cell temperature to
equilibrate.
Note: If the instrument is left idle in Rate Mode, the lamp may be OFF. Be sure to turn the lamp on and allow the
instrument its warm-up time before starting a reaction.
Note: Bichromatic readings should be used in any Rate Mode test. Always select a differential filter. 630 nm is
suggested for readings at 340 or 405 nm. See the section Bichromatic Readings.
Note: When using round test tubes in Rate Mode, the tube gasket supplied MUST first be installed.
To install the tube gasket, open the cover as described in the section Opening the instrument. Remove the
adhesive backing on the gasket. Apply the gasket to the top side of the read well. Be sure to align the round hole in
the gasket with the square opening in the read well.
Rate factors for determining units per litre (U/L) must be derived from the following standard formula:
U/L = A/min. x 1000 x TVmL x TF

MA x SVmL x LPcm
where:
U/L is units per Litre
A/min is the mean change in absorbance per minute
TV is the total volume of the reaction mixture (in ml)
3
MA is the molar absorptivity (i.e., the MA of NADH at 340nm = 6.22 x 10 )
SV is the sample volume (in ml)
LP is the cuvette light path (in cm)
TF is the temp factor used to convert assayed activity to the desired temp.

Refer to the sections Rate by Standard and Fixed Time Kinetics, below.
Rate Mode
Press PROGRAM (F2) then press 5 and Enter. The display shows:
Rate By Standard
Rate by Standard is very similar to Rate by Factor except that the factor is determined by dividing the given con-
centration of the standard by its A/min. This factor is then used to determine the concentration of the unknown
samples. The prompts are similar to those listed above for Rate by Factor.
If the standard absorbance is greater than 2.2, the mode is cancelled and the instrument returns to the main
prompt.
Fixed Time Kinetics

Fixed Time Kinetics is similar to the other Rate Mode variations. However, instead of basing the final calculation on
the A/min. of the sample, the calculation is based on the change in absorbance over the read interval. In addition,
the Low Activity and Check Linearity conditions will not be displayed, and neither Batch Rate nor interval data
reporting is available. This is also true for Batch Rate Modes.
Batch Rate Mode

Batch Rate Mode is used in conjunction with Rate by Standard or Rate by Factor to read tests simultaneously,
rather than consecutively. Because Fixed Time cannot be performed this way, the prompt is unavailable. Also, prior
to running the blank, the instrument prompts to enter the number of samples. Note that if running Rate by
Standard, The standard must be included as one of the samples. The maximum number of samples = 12.
After the blank is read, the display shows:
Rate by (Factor or Standard)
Add Serum/ Press Enter
Add the patient samples to the pre-warmed reagent tubes. Adding them in a uniformly-timed manner will ensure
that the lag time is consistent across the batch. After all samples have been added, press ENTER to begin the lag
time countdown. After the lag time is completed, the display will prompt to read the samples. Read the samples in
the same uniformly-timed manner in which the samples were added. Assign control labelling when the display is
prompting to read that sample. (The read time will begin when the initial reading of the first sample is taken.)
Note: The choice to set up controls does not function in Batch Mode. To use a control in Batch Mode you must
treat it like a sample and count it as one of your samples.
After all samples in the batch have had their initial reading, the instrument will count down the remainder of the
read time. At the end of the read time, the user will be prompted again to read the samples. Again, read the
samples in the same uniformly-timed manner in which the samples were added. After each sample is read, its
results will be printed. The instrument will print the actual read time for each sample, and will compensate with a
corrected Abs/min result. Note that interval data and plotting are not available, because the sample does not
remain in the cuvette well during the rate reaction.
After the last sample has been read, the printer will print
*** END OF BATCH *** and the Rate Mode will discontinue.
28
Rate By Standard
Press 1 to select Rate By Standard. The display shows the Select Filter Screen. Primary Filter is Highlighted. Press the
numeric key that corresponds to the desired wavelength. To confirm the choice, press ENTER. The selected
is chosen and press ENTER. The Wavelengths are then printed. Display shows:
Enter Lag Time (10 Seconds Minimum) and press ENTER (F4). You are then prompted to enter a Read Time. Read
Time must be a Multiple of 30. Enter desired time.
The instrument prompts the user to enter the value of Standard #1. Enter the value and press Enter.
The display shows the select Units Menu. Enter the units code (0-13) and press ENTER. Press YES to accept. See the
section Units of Measurement for details.
Save and name the test, as desired.
Display shows Referencing Air. The Display then asks for the Blank to be read. Its value is printed. The user will
then be prompted to read the standard. Insert the tube or sample the material. The display shows:

The Lag Time will first count down. Then the read time will begin counting down while charting the activity on the
Bottom Right of the screen. The F4 (ACCEPT) button can be used at any time after the lag time that the user feels
there is sufficient data to report a valid result. After the instrument is finished reading a sample, there will be three
buttons at the bottom. F1 (QUIT), F2 (MORE), and F4 (BLANK). Press the F2 (MORE) key. The display shows:
There are 4 Buttons now along the bottom of the display. MODIFY (F1), PLOT (F2), DATA (F3), and RETURN (F4).
MODIFY (F1) - This button is used to change the read interval. Press F1. The display shows:
The LEFT (F1) key is used to toggle between the two lines. The far right line indicating the end of read interval and
the left line at the beginning of the read interval. Pressing this button once will change its label to RIGHT. The
ARROW keys allow the user to move the two lines in order to select a portion of the graph for purposes of
calculating A/Min. by Linear Regression. Press OK (F4) to end. The instrument then prints the new A/Min. and
Factor.
Note: After modifying starting and/or ending times, the print data function still gives the original readings. If you
want to record the changes, you must print the modified graph.
PLOT (F2) - Press this key to plot and print the graph.
While the plot is being generated, the display shows:

Plotting...
The plot shows the absorbance along the vertical axis and the time along the horizontal axis. Note that a vertical
line indicates the break between the lag phase and the read phase, and the read time label of the horizontal axis
begins at the left bar.
If ranges were entered, the range interpretation is printed to the right of the concentration.
DATA (F3) - Press this key at any time before pressing RETURN (F4) to print the interval data. The absorbance at 0
and each 30 second interval is printed along with the mean absorbance per minute for each interval.
If any of the absorbances for the sample are greater than 2.2, a message is printed stating Absorbance > 2.2 and
the display shows the same.
If the absorbance per minute for any of the intervals is less than 0.010, the printer outputs Low Activity and the
display shows Low Activity next to Sample Done.
30
The option to print the data may then be taken by pressing the DATA button. The data can be examined to de-
termine if the sample was not active, if the substrate was exhausted early, or if the reaction started later in the
read time. If the latter is the case, the lag time may need to be increased.
If the absorbance per minute for any of the intervals was more than 20% from the mean absorbance per minute,
the printer shows Check Linearity and the display shows the same next to Sample Done.
Once again, the DATA button may be pressed to examine the data.
If neither Low Activity nor Check Linearity are flagged, the interval data may still be printed by pressing the DATA
key.
MORE (F4) - Press this key to see other options.
In the MORE menu, the display shows:
PURGE (F2) - Press this key to purge Flowcell.
RETURN (F4) - Press this key to return to sampling.
Re-Blanking may be done at any point by pressing BLANK. To exit Rate Mode and return to the main prompt, press
QUIT. The printer outputs Test Ended, and the instrument returns to the main prompt.
2.3 Stored Tests

The HumaLyzer 3000 stores up to 120 complete test setups in non-volatile memory, making it easy for the user to
recall complete test configurations. Each of the test parameters, including the mode, wavelengths, standards,
units, and the ranges are all stored for reuse. Blanks and standards (including entire standard curves) that have
been read are also saved. When the test is recalled, the user has the option of using the previous curve or reading a
new one. There are 44 Pre-Configured tests stored in the instrument, listed below:
1) ALBUMIN 23) UREA

2) BILIRUBIN DCA (Factor 12.5) 24) URIC ACID (Standard Mode)
3) BILIRUBIN DCA (Factor 58) 25) URIC ACID (Factor Mode)
4) BILIRUBIN 26) ACID PHOSPHATASE
5) CALCIUM 27) ALK PHOS
6) CHOLESTEROL (Standard Mode) 28) AMYLASE CT EPS
7) CHOLESTEROL (Factor Mode) 29) AMYLASE LIQUID
8) CREATINE 30) CK - MB
9) GLUCOSE GOD-PAP 31) CK NAC
10) GLUCOSE HK (Standard Mode) 32) GAMMA GT
11) GLUCOSE HK (Factor Mode) 33) GOT
12) GLUCOSE HK Hemol 34) GPT
13) HEMOGLOBIN 35) LDH
14) IRON (Standard Mode) 36) AA1 (APOA1)
15) IRON (Factor Mode) 37) AB1 (APOB)
16) MAGNESIUM 38) LPA
17) PHOSPHORUS 39) RF
18) POTASSIUM 40) ASO
19) TOTAL PROTEIN (Standard Mode) 41) CRP
20) TOTAL PROTEIN (Factor Mode) 42) IGA
21) TRIGLYCERIDE (Factor Mode) 43) IGG
22) TRIGLYCERIDE (Standard Mode) 44) IGM
There are also 6 Utility Tests. They are as follows:

201 Restore Hard Coded test parameters (listed above)
211 Enter serial number
213 Calibration Report
215 Enter all calibration settings
248 Enter Filter Labels for positions 7 & 8
249 Reset all filter labels to default

2.3.1 Recalling a stored test
Press RUN TEST (F1). The display shows a list of all available stored tests. If there is more than one page, use the
MORE button to advance the screen to the next page. Use the numeric keys to enter the test number and press
ENTER. The user is asked whether or not to print test header. If NO is selected, Test name and Stored Data is
printed. If YES, all test parameters are printed. Updated is the date the stored blank and standard values were last
updated. If there are no stored blank and standards, then the date is when the test was originally stored or last
edited.
The blank and curve data is printed and the display shows:
Use Stored Blank?
Press YES to use the stored blank. The stored value will be used as if it had just been read. If NO, the display
prompts to read a new blank. The display then shows:
Use stored Curve?
Press YES to use the stored factor or standard curve. If NO you will be asked to read new values. If recalling a Multi-
point % Abs Mode and choosing to use the stored calibration, the user will be asked to read the first standard only.
If a stored curve is not used, the display prompts the user to read the sample. If the test is assigned to a patient in
the worklist, the display shows:
Run the current worklist?
Press YES to use the current stored Worklist. Select NO to continue. The Display shows Referencing Air and then
Read the Blank. If there was no stored blank or standard curve, or the user has chosen not to use them, the values
that are read now will be automatically saved under the recalled test. When recalling the test the next time, the
option to use the stored calibration as described above will be displayed.
2.3.2 Listing stored tests

To print the list of all the stored tests, Press TOOLS (F4). Then Press 1 and ENTER. This opens the Stored Data
Utilities. Again Select 1 and ENTER. This takes the user to the Stored User Test Menu. Select 1 and ENTER.
2.3.3 Deleting a test

If finding that a stored test is no longer needed, it may be deleted. This makes room for another stored test. Use the
Procedure from Section 2.3.3 to get to the Stored User Test Menu. Then choose between Deleting all or 1 of the
Stored Tests. If selecting 3, Delete a stored test, the instrument prompts the user for a test number. Enter the
number of the test that should be deleted and press ENTER. The display then shows Delete Test ##? Press Yes to
confirm the deletion or No to cancel.
2.3.4 Editing a test

Any of the tests can be edited, and any of the stored parameters can be changed with the exception of the mode.
To edit a test, Use the Procedure from Section 2.3.3 to get to the Stored User Test Menu. Select 4, Edit a Stored Test,
and ENTER. Enter the number of the test to be edited.
Note: Editing a test will erase any stored blank or standard values for that test, as well as any patient results and
stored results (if available).
All of the tests parameters will be recalled and printed. The display shows:
(Stored) Mode
Edit Filters Y/N
Press YES to change the filter wavelengths, or NO to continue. The instrument prompts for the primary and dif-
ferential filters to be selected.
The instrument will ask a series of questions. If choosing YES, enter the new value just as when the test was
originally stored. The questions depend on the mode of the test being edited. For example, if editing a factor mode
test, the user will be asked to change the factor. If editing a rate test you will be asked if the lag and read times will
change. Upon completing the questions, the instrument prints Edit Complete.
32
2.3.5 Using WORKLIST
Press the WORKLIST (F3) Key. The Display shows the Patient ID Menu which consists of:
1 = Add a Patient To Worklist / Use this Feature to Add a Patient. See section 2.1.8 Entering Names. Once entered,
the printer prints New Patient Job List. As tests are entered for the patient, the printer adds them to the list. 15
Tests per Patient is the Maximum allowed.
2 = Run Worklist / Runs the entire stored Worklist or test by test.
3 = Print the Current Worklist / Prints the Current Patient Worklist. Under each Stored Test # and Test Name, the
print out shows which patients are assigned to the listed test. This is done for each Stored Test.
4 = Delete a Patient from Worklist / Use the PrintOut of the Patient ID list to find the corresponding Patient ID
number that will be deleted.
5 = Delete all of Current Worklist / When this function is chosen, The display asks: Delete the entire Worklist? Press
Yes to confirm, No to continue on Patient ID Menu.
When using the Worklist, the patient name is shown when prompting for a sample to be read. All results are stored
for later recall.
When the Worklist is finished the screen clears, the Patients reports print and you are prompted: Delete entire
Worklist? Choose yes or no.
Note: If a curve is invalid the following 3 lines are displayed and printed:
--CURVE INVALID--
Worklist stopped.
Please restart the worklist.
The test then ends and the Auto-Run Worklist mode is exited.
Note: Before adding patients to a Worklist, print the current Worklist (3), delete all (5) or delete patient by patient
(4) to delete the patients no longer being used, then enter the needed additional patients (1). This will prevent you
from running out of room for patients on your Worklist.
2.4 Special Features

2.4.1 Self-Check
The instrument continuously self-checks to insure proper operation. Any error will be immediately reported. The
Self-Check feature provides additional tests. To perform the check, press TOOLS (F4), then choose 4 (Diagnostics).
Note: The Flowcell and/or tubes must be removed to use this function. In the Diagnostics menu, choose 6 Self
Check and press Enter. The display shows:
The EEPROM, NV RAM, Vacuum System, Aspiration Valve, and Photometer are all checked. Test results will be
reported on the display and printer. For more information on error messages, see section 2.4.2, Error Messages or
section 3, Troubleshooting.

2.4.2 Flags and Error Messages
Flags are displayed to alert the operator when certain limits are approached. After displaying the warning the
instrument will continue to function normally.
***** is printed in the concentration field if the absorbance is greater than 2.5 when using tubes, or greater than 3.5
when using the Flowcell. To obtain an accurate absorbance and/or concentration for this sample it is necessary to
further dilute the sample(s), or dilute the specimen(s) and rerun the assay.
>10**7 is printed in the concentration column when the result of the concentration is greater than 7 digits and
cannot be printed in the concentration column.
CURVE INVALID!! is printed in the Multi-point mode when a curve cannot be drawn between the standards
that were read. An X will be printed after the standard which causes the curve to be invalid. Check to make sure
the standards were in decreasing order of absorbance in the Multi-point % Abs, or in increasing order if in Multi-
point Mode. Since this invalidates the results, the test must be restarted.
Error Messages
Error messages are displayed when the instrument fails to operate correctly. They are intended to help the operator
locate the problem.
Lamp Failure The lamp does not appear to be sufficiently illuminated. This can be caused
by either lamp failure or degraded filters. See the section Lamp Replace-
ment. If replacing the lamp does not correct this, the instrument may
require service to replace the filters.
Printer Paper Jam The internal printer paper path is obstructed. The internal printer will be
disabled, and the user will be allowed to continue. Clear the paper path by
gently pulling the obstruction from the printer, and re-starting the
instrument.
Printer Not Ready The external printer attached to the parallel port or serial port is out of
paper or otherwise unable to print.
Waste is Full!!!
(Bottle in top right corner of screen) Displayed when the waste material has reached the level sensors. XX sam-
ples remaining until the instrument shuts down vacuum and pauses.
Empty the waste bottle and replace the cap securely.
Empty Waste-Press Enter The instrument has paused until the waste bottle is emptied and press
ENTER.
MEMORY IS FULL The instrument can not store the test because there is no available
memory. Delete unused tests.
Check Vac System The instrument detected an inability to achieve vacuum. Check the waste
bottle cap and fittings.
The following messages may indicate an electronic problem with the main PCB. If these messages appear fre-
quently, the instrument may require service.
Memory Error The checksum for a test that is being recalled is found to be invalid. The
corrupted test is automatically deleted.
Filter Wheel Err There is a mechanical problem with the instrument. Turn off the power
switch, wait 15 seconds, then turn on the power switch.
Cancelled This is displayed immediately following a filter wheel error to indicate that
the test or mode has been ended.
34
Filter Labels 7&8 Clrd! The stored filter labels have been lost or corrupted. Refer to the section
Restore Filter Labels.
Water Values Reset The Flowcell is active and no water values were found in memory. The
stored water values have been reset to 0.000. new water values must be
read to ensure correct results. Refer to Flowcell Configuration.
Do Temperature Calibration Test The stored temperature adjustment has been lost or corrupted. Refer to
the section Restore Calibration Data.
Do ABS Calibration Test The stored absorbance adjustment has been lost or corrupted. Refer to the
section Restore Calibration Data.

36
Contents
3 CLEANING AND MAINTENANCE 38

3.1 Cleaning 38
3.1.1 Exterior 38
3.1.2 Flowcell 38
3.1.3 Waste Bottle 38
3.2 Maintenance 39
3.2.1 Calibration and Linearity 39
3.2.2 Opening the Instrument 39
3.2.3 Lamp Replacement 40
3.2.4 Flowcell Tubing Replacement 41
3.2.5 Valve Tubing Replacement 43
3.3 Storage 43
4 TROUBLESHOOTING 44
5 CONTACT INFORMATION 46
3 CLEANING AND MAINTENANCE
3.1 Cleaning
3.1.1 Exterior
CAUTION: Solvents such as acetone or thinner will damage the instrument! Use only water and recommended
cleaners! Avoid abrasive cleaners. The keypad and display areas are liquid-resistant, but are easily scratched.
The exterior of the instrument may be cleaned with a soft cloth using plain water. If needed, a mild all-purpose
(nonabrasive) cleaner may be used. A 1.5% solution of chlorine bleach or 70% isopropyl alcohol may be used as a
disinfectant. Take special care not to spill any liquid into the read well.
3.1.2 Flowcell
The Flowcell should be cleaned when the instrument will not be used for an extended period, e.g. overnight, end of
shift, and when storing the Flowcell. Proper cleaning will help to prevent clogging of the Flowcell tubing and valve
tubing. Cleaning is extremely important to obtaining accurate, repeatable results. If reagent, serum, or other
proteinaceous fluid is allowed to dry in the Flowcell, it is extremely difficult to remove and its presence can affect
test results.
To clean the Flowcell:
1. Purge with air for at least 5 seconds.
2. Aspirate a small amount of FLOW CELL CLEANER ([REF] 18222). Allow the solution to remain in the Flowcell for
3 minutes.
3. Aspirate 15 ml of distilled water then purge with air for 5 seconds.
4. Aspirate 0.1N hydrochloric acid (HCl). Allow the solution to remain in the Flowcell for 3 minutes.
5. Purge with at least 15 ml of deionised water.
6. Leave the Flowcell filled with water.
7. If preparing the Flowcell for storage, follow same instructions but purge completely after cleaning.
Material required
[REF] 18222 FLOW CELL CLEANER 100 ml

Detergent 0.1%
NaOH < 0.5%
Sodium azide 0.1%
Chemicals
HCl 0.1 N
Disinfectant:
Isopropylalcohol 70% or
Sodium hypochlorite (bleach) 1.5%
Warning
The above chemicals present the following hazards and should be handled with due care:
HCl and sodium hypochlorite are corrosive and toxic solutions which cause severe burns.
Propane-2-ol (isopropyl alcohol) is highly inflammable and harmful.
3.1.3 Waste Bottle

The waste bottle may be autoclaved or it may be cleaned with a commercially available all-purpose cleaner or
disinfectant. A 1.5% chlorine bleach solution or 70% isopropyl alcohol may also be used. Always turn instrument
OFF before disconnecting the waste bottle.
38
3.2 Maintenance
3.2.1 Calibration and Linearity
Each instrument is calibrated during manufacturing using standards that are traceable to the National Institute for
Standards and Testing (NIST), and is tested to verify its linearity to 2A. This pre-set calibration is very stable.
Absolute calibration can be verified with the use of NIST filters, or by periodic comparison to a reference instru-
ment that is known to be calibrated to NIST filters. Calibration may be confirmed using Awareness Technologys
Redi-Check, a commercially available calibration check set which can be obtained from your distributor. A periodic
verification of instrument linearity is advised.
Since most lab test results are based upon standards rather than upon absolute absorbance, the linearity of the
instrument is the more critical indicator of instrument performance. A reduction in linearity with age may be in-
dicative of optical filter deterioration. In this event, filter replacement is required for continued reliable operation.
The best way to assure quality instrument performance is to include a sufficient number of controls in each as-say
to cover the entire operational range.
3.2.2 Opening the Instrument

Refer to Figure 2 - Instrument Interior. The cover is hinged at the rear panel, and can be raised to allow access to the
inside of the instrument. Disconnect the power cable, the tubing, and the sensor lead from the rear panel. Remove
the waste bottle. Move the instrument forward until the front edge overhangs the work surface. Locate and
remove the cover screw from the middle of the underside of the front lip. Gently lift the front of the cover upward,
taking care to clear the photometer. Prop the cover open with a suitable object.
Do not force the cover backwards. Damage to the cover or fittings may result.
To reinstall the cover, reverse the procedure. Carefully lower the cover until it seats on the chassis, taking care to
clear the incubation block and the Flowcell Luer fitting.
MAIN PCB
Power
Supply
Pump
Photometer
Fan
Valve
Remove screw from

underneath to remove cover
Figure 2

3.2.3 Lamp Replacement
The lamp should be replaced only if it fails to light, or several filter voltages are reported as low.
To replace the lamp, follow the procedure below. Turn Power Off and unplug instrument.
Open the instrument as described in Opening the Instrument. Locate the photometer, and the lamp at the right
side of the photometer. Refer to Figure 3, Lamp Removal and Replacement. The figure shows the right side view of
the photometer assembly.
CAUTION: Lamp is HOT. Allow the lamp to cool before handling.
Loosen but do not remove the 2 centre lamp connector screws. Remove the lamp by lifting upward.
Use a pair of pliers or tweezers to handle the new lamp. Avoid handling with bare skin. Insert the lamp leads into
the connector until they hit bottom. Refer to Figure 3, Lamp Alignment. The lamp filament must be centred on the
lens and the lamp body must be parallel with the lens bracket. While holding the lamp in alignment, tighten the
lamp connector screws.
Set the power switch to ON. Observe the projection of the light from the lamp onto the cell holder (behind the
lens). Refer to Figure 3, Spot Alignment. The spot should be small and centred on the oval hole in the cell block
(behind the lens). If the spot is not centred, use the adjustment screws to position the spot. The vertical adjustment
screw raises and lowers the lamp bracket. The lamp bracket is slotted at the horizontal adjustment screw, so that
the lamp bracket can be moved. The horizontal adjustment screw serves to lock down the lamp bracket.
Insert a borosilicate 12 mm tube filled with plain water into the read well. Do not use a soda-lime glass tube, since
it does not transmit at 340nm. Press F4 (TOOLS). Press 4 and ENTER. Press 1 and ENTER The display shows the
voltages for each filter.
Figure 3
40
3.2.4 Flowcell Tubing Replacement
The Flowcell utilises 1.2 mm I.D. Teflon tubing for the sample and exit tubes. Replacement tubing is included with
the tubing kit. Follow this procedure to replace the Flowcell tubing.
Remove the Flowcell. Gently lift the Flowcell out of the read well.
Remove the cover screws and lift off the upper Flowcell cover.
Refer to Figure 4. Disconnect the exit tube from the steel tube. Pull the exit tube out through the bulkhead. Re-
move the cell insert screws and pull the cell insert and the sample tube out. Remove the sample tube from the steel
tube.
Find the sample tube. Carefully press fit the end of the sample tube, swaged end, to the steel tube on the cell
insert, and feed the other end upward through the cell body. Hint: grasp the tubing with a small piece of #400 grit
emery paper. Do not kink the tubing. Refer to Figure 4 for the proper orientation. Do not reverse the orientation as
improper sampling will result. Install the cell body and screws.
Feed the exit tube in through the rear of the Flowcell. Press the exit tube over the steel tube.
The exit tube and fitting should be installed as shown in Figure 5. Use extreme caution not to damage the fitting.

Flowcell Handle
Sample Tube
Support
Exit Tube
Sample Tube
(2) #4-40 x 3/8 Pan Head

screws w/ Split Lock
Washers
Flowcell Handle Base
(4) #4-40 x 1/4 Screws
(2) #2-56 x 3/16 Screws
Upper Cell Body
Cell Window
Cell Insert Screw
Adjustment Set Screw
Figure 4
42
Figure 5
3.2.5 Valve Tubing Replacement

It is not recommended to replace any tubing while the instrument is performing properly. However, the short
length of silicone tubing used in the sampling valve may become clogged or worn with age. A replacement is
included in the tubing kit.
Set the power switch to OFF (O). Open the instrument as described in Opening the instrument. Refer to Figure 6.
Locate the valve beside the photometer. Pull back the pinch bracket and remove the valve tubing from the valve
body.
Figure 6
Disconnect the valve tubing from the fittings at both ends noting orientation.
Install the replacement tubing to the valve body in a similar manner.
Push the tubing over the tubing barbs until seated. Be especially careful not to kink, stretch, or tension the tubing.
Lower the cover and replace the screw.
3.3 Storage
The instrument may be stored under the following recommended environmental conditions:
Temperature -10 to 50C
Humidity Less than 80% relative humidity, non-condensing.
Before storing the instrument, clean the Flowcell as described in Cleaning, Store using original packaging if
possible. Perform the following steps before storing.
Set the power switch to OFF (O) and remove the power cord.
Disconnect tubing and the sensor lead from the rear panel. Unhook the waste bottle strap and remove the waste
bottle. Remove the waste bottle cap.
Empty the waste bottle and autoclave, or disinfect with a 1.5% chlorine bleach solution.

Remove the Flowcell and allow the Flowcell and waste bottle to dry overnight.
Place the instrument, Flowcell, waste bottle in the original packaging material.
When returning the instrument to service from storage, it is recommended that functional tests be performed as if
setting up the instrument for the first time. It is especially important to verify sample volume accuracy and pho-
tometric linearity before performing any clinical assays.
4 TROUBLESHOOTING
Incorrect Control Readings
Check that the procedures and materials used were valid. Turbid or contaminated reagents may affect absorbance
readings. Reading reference dyes can be very helpful in separating instrument problems from reagent problems. Be
sure that the appropriate wavelengths were selected for the chromophore being read. Tubes should have no
bubbles, condensation, scratches or smudges.
Poor Linearity
If the instrument is several years old, or has been operated in very humid conditions, new optical filters may be
needed. The instrument incorporates interference filters of an advanced technology, and will provide extended life
in humid environments when compared to standard soft interference filters. However, excessive humidity should
be avoided. The instrument will require service to replace the filters.
Erratic Readings
One possible source of erratic readings (excessive dither) is trapped air in the Flowcell. This can be caused by
improper installation of the Flowcell tubing. Refer to the section Flowcell Tubing Replacement. Check the in-
sertion depth of the Flowcell tubes. Ensure that a leak-free seal is made.
Lamp failure
The lamp is rated to read over 300,000 tubes, and the lamp saver feature minimises lamp idle time. Lamp re-
placement is only indicated when the lamp fails to light, or when the message Lamp output low! is displayed.
Press LAMP to turn the lamp on or off. If the lamp fails to light, refer to the section Lamp replacement.
No sampling
If you can hear the valve cycle, but no sample is drawn up, the valve tubing may be blocked. Press and hold PURGE
several times. Disconnect the Luer fitting at the rear of the Flowcell. Press PURGE and listen for aspiration. If air is
heard entering the fitting, the valve tubing is clear, but the Flowcell is blocked. Refer to the sections Cleaning and
Replacing Flowcell tubing.
If the valve clicks but the pump does not run when pressing the PURGE key, the valve tubing may be stuck closed. If
this happens, remove the front cover screw and lift open the cover. Pull the pinch bracket against the spring
tension (to open the valve manually). Gently pull the tubing slightly to break the seal. See the section on Valve
Tubing Replacement for a diagram and more information about the valve tubing.
Restore Calibration Data

Each unit is electronically calibrated at the factory. The calibration values are entered by the keyboard and stored in
non-volatile memory. The instrument will not accept a change greater than +/- 10% (.900-1.100) for the
absorbance factor, nor will it accept a temperature offset change greater than +/- 2.5C. Only minimal calibration
adjustments are accepted from the keyboard.
Do Temperature Calibration Test
Do ABS Calibration Test
If either of these messages are printed or displayed, it indicates that the calibration values have been lost. These
messages will be printed each time that the instrument is turned on, a mode is selected, or a test is recalled. The
instrument will continue to operate, but the calibration must be restored to ensure the accuracy of the instrument.
WARNING: DO NOT ALTER ANY POTENTIOMETER SETTINGS !
Changing these settings will make the factory calibration data invalid.
In the unlikely event the calibration data is lost or corrupted, the absorbance factor is set to 1.000 and the
temperature offset adjustments for the cell are set to 0.0.
Do not enter values other than those recorded on the calibration label unless absolutely necessary.
44
Follow these steps to restore the electronic calibration:
1. Shut off the instrument. Remove any tubes or cuvettes from the read well. Carefully lift up the instrument and
locate the Calibration Data label on the underside of the unit. There are (2) values recorded there: Absorbance
and Cell Temp. Write down these numbers.
2. Set the power switch to ON(1).
3. If the date and time have been reset or are incorrect, enter the correct date and time. See the section Set Date
and Time
4. Press TOOLS (F4). Press 4 and Enter. The Diagnostics Menu is shown. Choose 3 for Absorbance Calibration and
Enter. Enter the Number.
5. Choose 4 for Temp Calibration and Enter. Enter the Number.
6. Press Run Test (F1), type in 213, and press ENTER to get a report of the calibration data. The cell temperature
adjustment will be printed along with the absorbance adjustment. Make sure that these values are the same as
those recorded on the calibration label.
Restore Filter Labels

Like the calibration data, the wavelengths for the two optional filters are stored in non-volatile memory. In the
event this data is lost or corrupted, the following message will be displayed and printed.
Filter Labels 7&8 Clrd!
Filter labels need to be re-entered for two of the filters. Open the instrument and locate the filter label on the side
of the photometer cover.
Key 7 is xxx
Key 8 is xxx
where xxx is a three-digit wavelength value. If there are no 7th or 8th filters, they will be listed as BLOCKED. Press
RUN TEST (F1), type in 248, and press ENTER. The display prompts:
Key 7 = ??? nm
Type in the wavelength for Key 7 that is printed on the label and press ENTER. Repeat for Key 8. use 000 for
unused filter positions. Press QUIT to return to the main prompt. Note that, if values for Key 7 and Key 8 are
entered when there are no filters present, the filters will be flagged as low when Self Check is run.
For Key 8. use 000 for unused filter positions. Press QUIT to return to the main prompt. Note that, if values for Key
7 and Key 8 are entered when there are no filters present, the filters will be flagged as low when Self Check is run.
Other Tests:
Vacuum count
The last 4 readings are averaged together and compared to 200
Greater than 203 shuts the vacuum off
Less than 197 turns it on.
Cell and block temp use the same cut-off numbers.

The last 4 readings are averaged together and compared to 462
Greater than 466 turns the heat off.
Less than 458 turns the heat on.
The Block heat temperature is not displayed if the count is less than 250
Waste count
A count of less than 150 is considered a full bottle condition.
The "Filter Wheel Speed" menu selection provides the user with the current wheel speed. The speed is set to
300 +/- 10

5 CONTACT INFORMATION
In the unlikely event that a problem is experienced with the instrument, please consult your dealer first.
Dealer:
If the dealer is unable to resolve the problem, our support staff at Human GmbH is happy to assist, and can be
reached in Germany by:
Fax: (49) 6122 9988 - 100

E-mail: tech-support@human.de
Mail: Human GmbH
Max-Planck-Ring 21
D-65205 Wiesbaden
Germany
When contacting Human GmbH, please provide the following:

The serial number of the instrument
A description of the problem with as much detail as possible
Printouts, which can be submitted by mail, fax or e-mail
46
HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 65205 Wiesbaden Germany
| Tel.: +49 61 22/99 88-0 Fax: +49 61 22/99 88-100
| e-Mail: human@human.de www.human.de

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HumaLyzer 3000

3 INTENDED USE OF THE INSTRUMENT [IVD]

4 GENERAL SAFETY WARNINGS

5 Human HumaLyzer 3000 User Manual

Environmental Conditions for

1.3 Warning Markings

WARNING Protective Ground CAUTION BIOHAZARD

1.3.2 Safety Terms

Terms which may appear in this manual:

1.4 Safety Precautions

7 Human HumaLyzer 3000 User Manual

Included items Description

Contact your distributor if anything is missing.

9 Human HumaLyzer 3000 User Manual

1.5.3 Keypad Description

Figure 1. Keypad Layout

11 Human HumaLyzer 3000 User Manual

1.7 Getting Started

1 = Set Date and Time:

Note: If using a Chinese instrument, the date is fixed YY.MM.DD

1.7.2 Printer Set Up

13 Human HumaLyzer 3000 User Manual

Note: These options may only be used if the Flowcell is active.

2.1.2 Lamp Warm-up and Lamp Saver

2.1.3 External Ports

2.1.4 Serial Port

15 Human HumaLyzer 3000 User Manual

2.1.6 Error Messages While Using the Parallel or Serial Ports

2.1.7 Units of Measurement

Press MORE (F2) to see the rest of the choices:

2.1.9 Ranges and Controls

17 Human HumaLyzer 3000 User Manual

19 Human HumaLyzer 3000 User Manual

1 = Stored User Test Menu: Press 1 and the display shows:

Press 1 to Print a menu of all of your stored tests.

3 = Stored Patient Result Menu. Press 3 and the display shows:

Press 1: Print a patient report by a Patient ID you select.

2.1.12 Reading Samples

21 Human HumaLyzer 3000 User Manual

2.1.13 Bichromatic Operation (Differential Filter)

2.2 Calculation Programs

The display shows:

2.2.2 Single Standard Mode

Press PROGRAM (F2). Select 2. The display shows:

23 Human HumaLyzer 3000 User Manual

2.2.4 Multi-point Mode

25 Human HumaLyzer 3000 User Manual

While the plot is being generated, the display shows:

2.2.5 Rate Mode

U/L = A/min. x 1000 x TVmL x TF

27 Human HumaLyzer 3000 User Manual

Fixed Time Kinetics

Batch Rate Mode

29 Human HumaLyzer 3000 User Manual

While the plot is being generated, the display shows:

2.3 Stored Tests

1) ALBUMIN 23) UREA

There are also 6 Utility Tests. They are as follows:

31 Human HumaLyzer 3000 User Manual

2.3.2 Listing stored tests

2.3.3 Deleting a test

2.3.4 Editing a test