HumaLyzer 2000

| User Manual

|
Cat.No. 18391
 Revision List of the Manual
No. Rev. / Date REVISION DESCRIPTION
1 03/2004-04 First edition
2 04/2008-09 Reformat
3 05/2008-11 Correction of small typing errors
4 02/2009-20 Adaption of maintenance chapter

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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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 TABLE OF CONTENTS

1. Introduction....................................................................................................................................................................................................................... 1

1.1 Application .............................................................................................................................................................................................................................. 1

1.1.1 Intended Use ................................................................................................................................................................................................................ 1
1.2 Specifications .......................................................................................................................................................................................................................... 1
1.3 Warnings and Precautions................................................................................................................................................................................................. 3
1.3.1 Environmental Conditions ...................................................................................................................................................................................... 4
1.3.2 Description.................................................................................................................................................................................................................... 4
1.4 Setup.......................................................................................................................................................................................................................................... 5
1.4.1 Unpacking ..................................................................................................................................................................................................................... 5
1.4.2 Parts and Controls...................................................................................................................................................................................................... 6
1.4.3 Preparation ................................................................................................................................................................................................................... 9
1.4.4 Checkout ......................................................................................................................................................................................................................11
1.4.5 Self-Check....................................................................................................................................................................................................................12
1.4.6 Getting Started..........................................................................................................................................................................................................12

2. Operating Instructions .................................................................................................................................................................................................15

2.1 General Selections...............................................................................................................................................................................................................15

2.1.1 Keypad Description..................................................................................................................................................................................................15
2.1.2 Flow Cell Configuration..........................................................................................................................................................................................17
2.1.3 Temperature Control ..............................................................................................................................................................................................17
2.1.4 Lamp Warmup and Lamp Saver..........................................................................................................................................................................18
2.1.5 Printers .........................................................................................................................................................................................................................18
2.1.6 Serial Port ....................................................................................................................................................................................................................19
2.1.7 Date Format................................................................................................................................................................................................................19
2.1.7.1 Set Date and Time ................................................................................................................................................................................................19
2.1.8 Units of Measurement ...........................................................................................................................................................................................20
2.1.9 Ranges...........................................................................................................................................................................................................................20
2.1.10 Entering Names......................................................................................................................................................................................................21
2.1.11 Controls .....................................................................................................................................................................................................................21
2.1.12 Reports .......................................................................................................................................................................................................................22
2.1.13 Blanking.....................................................................................................................................................................................................................22
2.1.14 Reading Samples....................................................................................................................................................................................................22
2.1.15 Bichromatic Operation (Differential Filter)..................................................................................................................................................23
2.2 Calculation Programs ........................................................................................................................................................................................................24
2.2.1 Absorbance Mode.....................................................................................................................................................................................................24
2.2.2 Factor Mode................................................................................................................................................................................................................25
2.2.3 Standard Mode..........................................................................................................................................................................................................27
2.2.4 Multi-point Mode.....................................................................................................................................................................................................29
2.2.5 Rate Mode ...................................................................................................................................................................................................................32
2.2.6 Rate by Factor.............................................................................................................................................................................................................34
2.2.7 Rate by Standard.......................................................................................................................................................................................................37
2.2.8 Fixed Time Kinetics ..................................................................................................................................................................................................37
2.2.9 Batch Rate Mode.......................................................................................................................................................................................................38
 2.3 Stored Tests ...........................................................................................................................................................................................................................39
2.3.1 Storing a Test .............................................................................................................................................................................................................39
2.3.2 Recalling a Stored Test............................................................................................................................................................................................39
2.3.3 Listing Stored Tests..................................................................................................................................................................................................40
2.3.4 Deleting a Test...........................................................................................................................................................................................................40
2.3.5 Editing a test ..............................................................................................................................................................................................................40
2.3.6 Pre-Programmed Tests...........................................................................................................................................................................................42
2.3.7 Restoring a Test.........................................................................................................................................................................................................43
2.4 Auxiliary Menu.....................................................................................................................................................................................................................44

3.0 Cleaning and Maintenance.......................................................................................................................................................................................45

3.1 Cleaning .................................................................................................................................................................................................................................45

3.1.1 Exterior .........................................................................................................................................................................................................................45
3.1.2 Flow Cell.......................................................................................................................................................................................................................45
3.1.3 Waste bottle...............................................................................................................................................................................................................45
3.2 Maintenance...................................................................................................................................................................................................................... 466
3.2.1 Calibration and Linearity .................................................................................................................................................................................... 466
3.2.2 Opening the Instrument........................................................................................................................................................................................47
3.2.3 Lamp replacement ...................................................................................................................................................................................................49
3.2.4 Flow Cell Tubing Replacement ............................................................................................................................................................................51
3.2.5 Flow Cell Adjustment..............................................................................................................................................................................................51
3.2.6 Valve tubing replacement.....................................................................................................................................................................................53
3.2.7 Waste Bottle Maintenance...................................................................................................................................................................................54
3.2.8 Storage .........................................................................................................................................................................................................................55

4. Troubleshooting .............................................................................................................................................................................................................56

4.1 Flags and Error Messages .................................................................................................................................................................................................56

4.1.1 Flags...............................................................................................................................................................................................................................56
4.1.2 Error Messages ..........................................................................................................................................................................................................56
4.1.3 Incorrect control readings .....................................................................................................................................................................................57
4.1.4 Poor linearity ..............................................................................................................................................................................................................58
4.1.5 Erratic readings .........................................................................................................................................................................................................58
4.1.6 Lamp failure................................................................................................................................................................................................................58
4.1.7 Pump runs continuously........................................................................................................................................................................................58
4.1.8 No sampling ...............................................................................................................................................................................................................58
4.2 Restore Calibration Data ..................................................................................................................................................................................................59
4.2.1 Restore Electronic Calibration .............................................................................................................................................................................59
4.2.2 Restore Filter Labels.................................................................................................................................................................................................60
1. INTRODUCTION

1.1 Application

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 wavelengths. 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.

1.2 Specifications

Specification Date .............................................. 24 January, 1997

Model Name ......................................................... Humalyzer 2000, Cat. No. 18-300
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 700 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
................................................................................... Fixed Time Kinetic
................................................................................... By Factor or by Standard
Channels ................................................................ 44 fixed, 15 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 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

1 Human HumaLyzer 2000 User Manual

Specifications (Continued)

Cuvette ...................................................................
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
Other Vessels .............................................. 12 mm test tubes
................................................................................... 1 cm square cuvettes
Cuvette Holder..................................................... Thermostatically controlled compartment at 37 C
Detector.................................................................. Gallium-Arsenide-Phosphide photodiode
Signal Processing and Display
Display Type ................................................ 2 line x 24 character super twist LCD
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 2.0 absorbance
Signal Outputs
Parallel .......................................................... Centronics/IBM-PC compatible
Serial............................................................... RS-232 at 2400 baud, 8 data, 1 stop, no parity
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 warmup
................................................................................... Better than 0.001 A/hr bichromatic after warmup
Warmup Time...................................................... 90 seconds photometric
................................................................................... 15 minutes for temperature compartment
Electronics ............................................................. Z80 microprocessor
................................................................................... 8 K bytes Static RAM (SRAM)
................................................................................... 8 K bytes Non-volatile RAM (NVRAM)
Power Supply........................................................ 115/230 VAC, 50/60 Hz, +/- 10%, 60 VA
Dimensions and Weight ................................. 35 x 40 x 15 cm, 10 kg
Space Requirements.......................................... 10 cm clearance on all sides

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1.3 Warnings and Precautions

WARNING

Some diagnostic assays utilize material which is potentially biohazardous. Always wear
protective apparel and eye protection while using this instrument. Always operate the
instrument with safety equipment and fixtures in place.

If the waste bottle is overturned during operation, immediately set the power switch to OFF
(O). If this occurs, the instrument may discharge a small amount of waste material from the
waste bottle via a fitting on the bottom of the unit. This material should be treated as
potentially biohazardous.

CAUTION

The voltage select switch setting must match the local AC line voltage or permanent
damage to the instrument may occur.

The instrument must be operated will all covers and dress panels in place. Do not block the
fan outlet at the rear of the instrument or block the air inlets on the underside of the
chassis. Observe clearances around the instrument.

Solvents such as acetone or thinner will damage the instrument. Do not use solvents to
clean the unit. Avoid abrasive cleaners. The cover, keypad and display are liquid-resistant,
but are easily scratched.

Please take time to read this manual carefully before using the instrument. For best results,
familiarize yourself with the instrument and its capabilities before attempting any clinical
diagnostic tests. Refer any questions to your instrument dealer.

Retain the original packing material for future use in the event that the instrument is placed
in storage, shipped to another location, or returned for service.

3 Human HumaLyzer 2000 User Manual

1.3.1 Environmental Conditions
This instrument is intended for indoor use at temperatures between 15C and 35C and at between 10% and 85%
relative humidity, non-condensing. The instrument must be placed on a stationary flat working surface at least 61 cm
deep. The instrument must have at least 10 cm clearance at the sides and rear.

1.3.2 Description
The instrument is a general-purpose, bichromatic photometer system with six available wavelengths and 37C
incubation. Two additional wavelengths are optional. A removable Flow Cell installs in the read well to provide
extremely rapid fluid sampling with low carryover. A built-in vacuum pump and an external autoclavable waste bottle
with level sensing are supplied standard. When the Flow Cell is removed, the instrument accepts standard 12 mm
round tubes as well as 1 cm square cuvettes. The instrument also contains an incubation block with 12 round tube
stations. Both the incubation block and the read well are temperature controlled to 37C.

The design of the instrument includes many features to minimize operator error, such as stable factory calibration,
automatic zeroing, complete operator prompting, detailed labeling, pre-programmed calculations, visual and audible
feedback, flags and error messages, and minimal maintenance requirements.

The operating modes are:

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 change in 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.

Absorbance Mode reads monochromatic or bichromatic differential absorbances at user-selected wavelengths.

Multi-point Mode reports concentrations or percent absorbances based on the point-to-point connection of up
to seven user-supplied standards.

In the Factor and Standard modes, differential samples (against sample blanks) are supported.

Tests, parameters, and standard curves are stored in memory for later recall. The first 44 tests are pre-programmed for
use with assays available from Human GmbH. You can customize the parameters and standards of these tests as
needed to meet your assays specific requirements. In addition to the pre-programmed tests, you can program an
additional 15 user tests for later recall.

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1.4 Setup

1.4.1 Unpacking
Carefully unpack the instrument. Report any visible damage to your freight carrier at once.

NOTE: Retain the original packing material for future use in the event
that the instrument is placed in storage, shipped to another location or
returned for service.

You should find the following items packed with the instrument. Please locate each item now before you continue.
Remove all packing material and retain.

Included items Description

Waste bottle Glass bottle ,vinyl-clad

Cleaning solution Plastic bottle containing Flow Cell cleaning solution

Bottle cap assembly Bottle caps, tubes, sensor wires

Paper rolls (2) Thermal printer paper

Paper roll cover Smoked plastic

Power cable Heavy cord

Flow Cell Rectangular object with square extension, in plastic box

Spare tubing and tool kit Description

Valve Silicone tube

tubing

Sample tube, long Teflon tube, swaged end, for sample vol. >350l

Sample tube, short Teflon tube, swaged end, for sample vol. - 350l

Exit tube Teflon tube w/ male Luer attached

Tube gasket Foam rectangle with round hole

Tubing gripper Rectangle of emery paper

Hex wrench 1.6 mm

Owners Manual This document

Contact your distributor if anything is missing.

5 Human HumaLyzer 2000 User Manual

1.4.2 Parts and Controls

C B

A E

D K

F J
I

Parts and Controls (Front of instrument)

A Rear dress panel

B Printer

C Printer paper roll

D Display

E Keypad

F Incubation block

G Sample tube

H Sample bar

I READY indicator

J Flow Cell

K Flow Cell exit tube

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 Parts and Controls (Continued)

7 Human HumaLyzer 2000 User Manual

Parts and Controls (Continued)

I
B

C J

E F H

Parts and Controls (Rear of Instrument)

A Parallel port

B Sensor jack

C Vacuum fitting blue

D Waste fitting (white)

E Bottle strap

F Fan outlet

G Serial port

H Power inlet

I Power switch

J Voltage select switch

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 1.4.3 Preparation

1. Complete this procedure to prepare the instrument for operation.

2. Place the instrument on a flat working surface capable of safely supporting the weight of the instrument,
approximately 10 kg. A clearance of at least 10 cm around the instrument is required to assure optimal
ventilation.

3. 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. Figure 6 (located immediately before the section
Valve tubing replacement shows a diagram of the valve tubing location. Replace the cover and continue.

4. Refer to Figure 1 for the remainder of this procedure. 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.

5. Connect the waste bottle tubes to the rear panel fittings. The tubing connections are color-coded; match the
male Luer cap to the color coding ring on the rear panel. The vacuum line fittings are blue and the waste line
fittings are white. Turn the fittings clockwise only until finger-tight. Do not over tighten.

6. Plug the sensor lead into the sensor jack on the rear panel.

7. 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.

8. Locate the power switch on the rear panel. Check that the power switch is in the OFF (O) position.

9. Locate the voltage select switch on the rear panel. This switch configures the instrument to accept either 230
V or 115 V input. Do not connect the instrument to the AC supply before checking the voltage select switch.
Ensure that the voltage select switch is set to the correct voltage. To change the voltage select switch, insert a
straight screwdriver blade into the slot on the switch, and slide it firmly into the other position.

WARNING: The voltage select switch setting must match the local AC line voltage or permanent damage to the
instrument may occur.

10. 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. For use at 110-120 V in the United States, you must use a UL listed cord set with a
minimum 18 AWG, Type SVT or SJT 3 conductor cord, maximum 15 feet (4.5 m) in length, rated 10A, 125V,
with a parallel blade, grounding type attachment plug. For use at 220-240 V in the United States, use a UL
listed cord as above, rated 250V, with a tandem blade, grounding type attachment plug. For use elsewhere,
refer to local regulations.

11. Install the Flow Cell in the read well so that the sample tube is toward the front and the exit tube is toward
the rear. Press the Flow Cell gently down into the read well. Connect the fitting on the exit tube to the fitting
on the instrument. Turn the fitting clockwise only until finger-tight. Do not over tighten.

9 Human HumaLyzer 2000 User Manual

12. Set the power switch at the left rear of the instrument to ON (1). The display shows

Humalyzer 2000 G

The printer will print several lines. Wait until it has stopped.

13. Locate the roll of printer paper. Roll out 15 cm of paper from the roll. Be sure that the leading edge of the
paper is straight. Cut it straight across with scissors if needed. Feed the leading edge of the paper into the slot
inside the opening in the rear dress panel. Figure 1 shows the direction of the paper feed. While feeding the
paper as described, press the PAPER key repeatedly until the paper "catches" and begins to feed into the
printer. When you see the printer paper exit at the top of the printer, stop pressing the PAPER key.

14. Locate the paper roll cover. Install to the opening in the rear dress panel, by pressing inward on the tabs on
each side of the printer roll cover.

15. Locate the bottle of Flow Cell cleaning solution. Open the bottle and position it so that the sample tube is
immersed in the solution. Press PURGE to aspirate cleaning solution into the Flow Cell. Remove the bottle of
cleaning solution and replace the cap. Allow the solution to remain in the Flow Cell for 3 minutes.

16. Position a container of distilled water so that the sample tube is immersed. Press PURGE to aspirate water
into the flow cell. Allow the water to remain in the Flow Cell for 3 minutes.

17. Press and hold the PURGE key until no more water can be seen flowing into the waste bottle.

18. Set the power switch to OFF (O) and continue to the section Checkout.

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 1.4.4 Checkout
Follow this procedure to verify that the instrument is ready for use.

In this procedure, it is assumed that the Flow Cell is being used. If you are using the instrument with tubes or
square cuvettes, disregard the Flow Cell 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.

Flow Cell is fully seated in read well and Luer fitting is connected. (If Flow Cell in use.)

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 left rear of the instrument to ON (1)

The display will show:

Humalyzer 2000 G

The printer will print a header containing the instrument model, software revision, laboratory name, and the date
and time.

Humalyzer 2000 G
Lab: LABNAME
01/01/94 08:30
Flow Cell Active

The letter following the colon is the software revision. If the date and time are incorrect, set the date and time as
described in the section entitled Set Date/Time.

Allow the instrument to equilibrate for at least 15 minutes. The incubation block and the read well must be at 37C.

11 Human HumaLyzer 2000 User Manual

 When the instrument is ready for use, the display will show the main prompt:

Ready: Select a Test

Block: 37.0 Cell: 37.0

Press and hold the PURGE key. The valve will open and you will hear the internal pump running to restore
the vacuum. Release the PURGE key. The valve will close and the pump will continue to run for about 15
seconds, and then shut off. The pump may run intermittently as the vacuum stabilizes.

If the instrument produces results other than those described here, set the power switch to OFF (O). Go to the
section entitled Setup and review all steps carefully. Repeat the Checkout procedure. If the instrument still
produces results other than those described here, refer to the section entitled Troubleshooting, or contact your
dealer for assistance.

1.4.5 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 the SELF CK key. The display shows messages such
as this when performing the tests:

System Diagnostics:
SRAM OK

Any test failures will be reported on the display and printer.

1.4.6 Getting Started

There are 44 pre-programmed tests available for use with Human assays. All of the test parameters, including the
mode, wavelengths, standards, units, and ranges are stored for reuse. Blanks and standards (including entire
standard curves) that have been read are also saved.

To recall a test, press MENU. The instrument prompts you to enter the number of the test you wish to run. Use the
numeric keys to enter the test number and press ENTER. The test is recalled and the test parameters are printed. To
print a list of all of the tests, press MENU, type in 99, and press ENTER. The listing is included at the end of this
section. For a closer look at the instruments capabilities, refer to the other sections of the manual. This section
gives you brief step-by-step instructions to use the instrument with the Human GLUCOSE liquiUV Hexokinase
method test, in standard mode.

Before continuing, be sure the instrument is prepared for use by completing the procedures in the sections entitled
Setup and Checkout.

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 You may cancel any operation at any time and revert to the main prompt by pressing CLEAR twice.

Press MENU. Type 10 and press ENTER. The display shows:

Standard Mode

The printer outputs a header showing information about the stored test:

10)Glucose HK (S) Name of test

Updated: 01/01/94 Date last updated/modified
01/01/94 :G 14:55 Current date, software revision, time
Standard Mode Operating mode
Sample Volume=500uL Aspiration volume (indicates Flow Cell Mode)
Wavelngths=340 630nm Filter wavelengths (primary/differential)
Standard#1= 100.0 Standard #1 is equal to 100.0 units
Norms: 75.0to 115.0 The normal range is 75 to 115 units
Linear: to 700.0 The test is linear up to 700.0 units
--------------------
S# Abs mg/dL I Sample#, Absorbance, Units, Index
--------------------

If the lamp has not completed its 90 second lamp warmup, the display shows:

Standard Mode
Lamp Warmup: XX Secs

The lamp warmup time shown is the number of seconds remaining until the lamp has reached operating
temperature.

When the lamp warmup is complete, the display shows:

10)Glucose HK (S)
Read the blank

Position the container of blank reagent under the sample tube so that the tube is below the

NOTE: The instrument automatically purges with air after making the
absorbance readings. Be sure to remove the sample container after the
instrument beeps.

Fluid surface. When the green READY light on the front of the instrument is on, press and release the
sample bar. The instrument will beep, and then aspirate the sample. Remove the blank material from the
sample tube after the sample is aspirated. The instrument purges with air automatically after the
absorbance is read. The sample tube must not be immersed when this occurs.

The display shows:

10)Glucose HK (S)
Sampling
10)Glucose HK (S)
Reading

The printer outputs the absorbance and concentration for the blank and the display briefly shows it as
well:

B 0.227 0.0

13 Human HumaLyzer 2000 User Manual

 The display then shows:

10)Glucose HK (S)
Read Standard

Aspirate the standard fluid as described above for the blank. Remove the container when you hear the
beep. The printer outputs the absorbance, concentration, and factor for the standard:

S1 1.105 100.0
Factor= 90.5

The display then shows:

10)Glucose HK (S)
Read Sample

Aspirate the sample fluid as described above for the blank. Remove the container after you hear the beep
and the sample is aspirated. The printer outputs the sample number, absorbance and concentration for
the sample and the display shows it as well. Note that the letter to the right indicates a low value (out of
normal range).

1 0.551 49.8L

You may continue to read samples, or you may cancel and return to the main prompt at any time by pressing CLEAR
twice in succession. You may re-blank at any time by pressing BLANK and repeating the steps listed above for
blanking. A listing of pre-programmed tests can be found under Pre-programmed tests in the section Operating
Instructions: Stored Tests.

14
2. OPERATING INSTRUCTIONS

2.1 General Selections

2.1.1 Keypad Description

Refer to Parts and Controls and Figure 2.1.1-1, Keypad Layout. Many keys have multiple features, some of which are
active only in certain modes. In general, the left-hand keypad is used for mode selection and numeric data entry,
whereas the right-hand keypad is used for selecting options, programming and configuration. Below is a brief
description of each key. Keys with multiple features are listed as separate keys.

Figure 2.1.1-1 Keypad Layout

Left-hand keypad

0-9 Numeric input

STND Selects Standard Mode

RATE Select Rate Mode

FACT Select Factor Mode

ABS Select Absorbance Mode

PGM Selects Multi-point (programmable) mode & Multi-point % abs mode

%ABS Has no function

DATA Prints Rate-by-factor interval data

AUX Access Auxiliary menu

15 Human HumaLyzer 2000 User Manual

Left-hand keypad (Continued)

PLOT Plot curves or Rate reactions

BLANK Read blank

LAMP Turn lamp on/off

PAPER Feed paper on internal printer

CLEAR Clear input or revert to previous/main prompt

ENTER Accept input

Right-hand keypad

STORE Save test

EDIT Modify test data

DEL Delete currently selected test

TEMP Display current block/cell temperature

CELL Configure Flow Cell

VOL Set sample volume

FILT Print menu of available wavelengths

UNITS Print menu of available units of measurement

SELF CK Perform internal self-check

TIME Display or edit date/time

PRNT Select printers

PURGE Purge Flow Cell

MENU Recall stored tests

READ Select characters from list

16
 2.1.2 Flow Cell Configuration
The Flow Cell configuration allows you to select tube mode or make the Flow Cell active, change the aspirate
(sample) volume, and read and store water reference values. When installing the Flow Cell to an instrument that
has already reached temperature equilibration (about 15 minutes from power-on), allow at least 5 minutes for the
Flow Cell to equilibrate after insertion. For optimal performance of the Flow Cell, be sure that the instrument is
placed on a level surface.

Press CELL to configure the Flow Cell settings. The display shows:

Flow Cell Settings

Flow Cell Active Y/N

Press NO to use tubes or cuvettes, or press YES to use the Flow Cell. If you select NO, remove the Flow Cell before
continuing. If you selected YES for Flow Cell active, install the Flow Cell before continuing.

Flow Cell Settings

Change Aspirate Vol Y/N

Press NO to continue or press YES to change the aspirate volume. If you press YES, the display shows:

Flow Cell Settings

Sample Volume 750uL Y/N.

Press YES again to select the volume shown or press NO to show other available volumes. The available sample
volumes are 250, 300, 350, 400, 450, 500, 600, and 750 l. Press YES to select the displayed volume. The printer
outputs the volume that you select. Note that the VOL key performs this function directly.

NOTE: If you select a sample volume which is 350 l or less, you must also
install the shorter sample tube (3.8 cm) provided in the tubing kit. Refer
to the section Flow Cell tubing replacement.

The display then shows:

Flow Cell Settings

Read Water Y/N

Press YES to read a new water reference, or press NO to continue. The instrument references water instead of air
when reading with the Flow Cell. These reference values are stored in non-volatile memory. The instrument uses
the stored values whenever the Flow Cell is active, until new values are read.

2.1.3 Temperature Control

When no software mode is selected (press CLEAR twice), the temperatures of the read well and incubation block are
displayed continuously. The display shows (for example):

Ready. Select a Test

Block: 37.0 Cell: 36.8h

The temperature of the cell and block is automatically controlled to 37C by the software. A small h will appear
after the temperature when the heating element for the particular incubator is turned on.

17 Human HumaLyzer 2000 User Manual

 The cell temperature control can be disabled for use at ambient temperature. To enable or disable cell temperature
control, press TEMP. The display shows:

Ready: Select a Test

Cell T.Cntrl 1=ON 0=OFF

Press 0 to disable cell temperature control, or 1 to enable. If cell temperature control is disabled, the message Cell
Temp Ctrl Off! is printed. Selecting any of the Rate Modes will automatically enable cell temperature control. Note
that even with temperature control disabled, the ambient temperature of the cell is somewhat higher than room
temperature.

Allow at least 15 minutes for the instrument to equilibrate after enabling or disabling cell temperature control.
When installing a room-temperature cuvette or the Flow Cell 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.

To view the temperature at any time, press TEMP. The prompt to turn cell temperature control on or off clears after
a moment and the temperature is displayed for several seconds.

2.1.4 Lamp Warmup and Lamp Saver

The lamp must warm up for 90 seconds before any readings can be taken. As soon as the lamp is turned on the
warmup time begins and continues to count down. If you select a test very quickly, the instrument will pause until
the warmup time has elapsed. The message Lamp Warmup:XX Secs is displayed and the time XX will count down to
zero. When the warmup 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. The display shows Lamp Saver. Select a test or mode, or press LAMP to turn the
lamp on.

2.1.5 Printers
The instrument has a built-in 20 column thermal graphics printer that is used to list information and provides a
record of the samples.

An external printer may be connected to the parallel or serial port on the rear of the unit. Any Epson compatible
printer and standard parallel cable may be used with the parallel port. Contact your distributor for a special cable
for use with a serial printer.

When connecting an additional printer or an external PC, the instrument must be switched off. After terminating
the connection, you may put the instrument into operation again.

To advance the paper, press PAPER. The paper continues to advance as long as you hold down the key.

To select printers, press PRNT. The display shows:

Ready: Select a Test

Internal Printer ON Y/N

Press YES to enable the internal printer, or press NO to disable. The display then shows:

Ready: Select a Test

External Printer ON Y/N

18
 Press YES to enable external printer or press NO to disable. You may select either, both, or neither of the printers.
The data is output to both printers in the same format.

If the external printer is enabled, and the printer is connected but is off-line, an error results when the instrument
attempts to print. The instrument stops and displays PRINTER NOT READY until the problem is corrected.

In the event that the external printer buffer becomes full (i.e., the instrument has sent as much data as the printers
memory can hold), the instruments display will prompt you to Retry. You may retry to continue printing after the
printer has emptied its buffer.

2.1.6 Serial Port

By using a special cable, a serial printer or computer with a serial port may be connected. This is a male 9-pin DB-
style connector using RS-232 signals in a non-standard pin out. The data format is 2400 baud, 8 bits, 1 stop bit, and
no parity. Contact your distributor to obtain a serial printer cable.

The pin out for the serial port is:

1 GND

2 TX

3 RX/DTR

4-9 NC

2.1.7 Date Format

The date can either be displayed as DD.MM.YY (day, month, year) or as MM/DD/YY (month, day, year). To change
the date format, press MENU, enter 100, and press ENTER again. The display will show:

Ready: Select a Test

0=MM/DD 1=DD.MM

Press 0 for MM/DD/YY or press 1 for DD.MM.YY, and then press ENTER.

Press TIME to check the date and time. The current date and time are displayed for approximately two seconds, and
then cleared. The date and time are printed automatically when you start the instrument, and when you select a
software mode.

2.1.7.1 Set Date and Time

To change the time and date, press TIME, then press EDIT. After about one second, the display will show:

Ready: Select a Test

Enter Date as DD.MM.YY

or

Ready: Select a Test

Enter Date as MM/DD/YY

depending on the date format currently selected.

19 Human HumaLyzer 2000 User Manual

 Using the numeric key pad, type in the day, month, and year; or the month, day and year, depending on the date
format. Each must be two digits. You may separate each number with either a slash or a decimal point. In the first
example, to set the date to 15 May, 1997, type in 15.05.97 and press ENTER. You may leave the date unchanged by
simply pressing ENTER.

After you have entered the date, you are prompted to enter the time as HH.MM.SS. Enter the hours, minutes, and
seconds (24 hour format) in the same way that you entered the date.

2.1.8 Units of Measurement

In all modes except Absorbance Mode, you have the option of selecting units of measurement. Units are provided
to label the calculated concentrations, but have no bearing on the actual calculation. The display shows:

(Mode Name) Mode

Enter Units Code

There are fourteen unit codes. To list the codes and the units, press UNITS and the complete list will be printed:

Unit Menu by Key

0 Conc 7 meg/dL
1 g/L 8 mmol/L
2 g/dL 9 mcmo/L
3 mg/dL 10 IU/mL
4 g/L 11 kat/L
5 g/dL 12 mol/L
6 U/L 13 mol/L

When prompted to select units, press the numeric key that corresponds to your choice. The units for that code are
displayed. To confirm your choice press ENTER. To select a different unit, press a different numeric key.

2.1.9 Ranges
In all modes except Absorbance Mode you have the option of entering ranges. The ranges are saved when a test is
saved.

When the display shows something similar to:

Standard Mode
Set Ranges Y/N

press YES to set ranges. If you press NO, the instrument will continue normally.

Standard Mode
Enter Low Normal

Enter the concentration that is the lowest value of the normal range. The instrument then prompts you to enter the
high normal. Enter the highest value in the normal range.

You then have the option to enter the low and high value of the linear range. Enter the values as for the normal
range.

20
 Any value can be skipped by simply pressing ENTER.

For example, if you enter 20, 50, 10, 100 for the four values, the ranges will be printed as

Norms: 20.0 to 50.0

Linear: 10.0 to 100.0

When the instrument takes a reading, a letter indicating the range (none, L, H, R) is shown to the right of the
concentration on both the display and the printer.

Standard Mode
3 0.785 60.5H

The possible range letters are:

None The concentration fell inside both the normal and linear ranges.

L The concentration is lower than the Low Normal, but is inside the linear
range.

H The concentration is higher than the High Normal, but is inside the linear
range.

R The concentration is outside the linear range.

2.1.10 Entering Names

It is sometimes necessary to enter an alphanumeric name. For instance, you can name user tests and controls, and
you can change the laboratory name shown in the header. When you are prompted for a name, the following
display is shown:

ABCDEFGHIJKLMNOPQRSTUVWX

<4 6> READ=Let ENT=Done

The cursor is the small underline beneath the A on the top line. Press 4 to move the cursor to the left or press 6 to
move the cursor to the right. When the cursor is beneath the first letter of the name you wish to enter, press READ.
The bottom line clears and shows the letter that you selected. Continue using the 4 and 6 keys and READ to select
each letter in the name. You can hold down 4 or 6 to move the cursor quickly. When you complete the name, press
ENTER. If you wish to remove a letter from the end of the name, press CLEAR. To cancel and return to the main
prompt, press CLEAR twice.

2.1.11 Controls
The instrument allows you to enter and name up to 4 controls. Controls are designated samples which provide an
expected result, providing a reference for comparisons. The controls can be given names up to 15-characters in
length. When the display shows "Read Sample", you can designate the next sample as a control by pressing AUX.
The display then shows

Label as Control Y/N

Press YES to view the control names. The display will show each of the control names in order. Press NO to view the
different control names, or press YES to select the displayed control name and designate the next sample as a
control.

For information on naming the controls, see the section Auxiliary Menu.

21 Human HumaLyzer 2000 User Manual

2.1.12 Reports
The instrument provides full-page reports to the external printer, showing the stored patient data and
interpretations along with logged information such as the test name, date and time, controls used, and includes
spaces for laboratory and technician information. Patient data is stored and retrieved by test number, and there is
room for a total of 255 samples.

To print a report:

1. At the end of shift or reporting period, press CLEAR twice so that the instrument is at the main prompt. Press
DATA. The display shows:

Printing Data Report

Select a Test

2. Type in the desired test number and press ENTER. The display shows:

Setup External Printer

Then Press Enter

3. Load the external printer with paper and set it to top of form. Make sure the printer is on line, and then press
ENTER to print the report. The display shows:

Printing Data Report

4. When the report is complete, the display shows:

Report printed
Clear Samples Y/N

5. Press YES to clear the samples for the test you selected. None of the other samples will be affected. Press NO
to return to the main prompt without clearing the samples.

You can repeat this procedure as needed for any or all tests.

2.1.13 Blanking
The instrument prompts you 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 Flow Cell mode, it is relative to the
stored water values. In this way the user can evaluate the suitability of the blank before using it.

2.1.14 Reading Samples

Using tubes or cuvettes:

The instrument prompts you 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, you may
remove the tube. The instrument prompts you to insert the next tube.

22
 Using the Flow Cell:

The READY indicator on the front of the instrument will light and the display will prompt you 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. Quickly press and
release the sample bar. The instrument will automatically sample the preset amount. Remove the sample
container from the sample tube after you hear the instrument beep. When the reading is complete the sample
will be automatically purged from the Flow Cell and drawn into the waste bottle at the rear of the instrument.
When the instrument is ready for the next sample, the READY indicator illuminates, and the instrument
prompts you to read the next sample.

2.1.15 Bichromatic Operation (Differential Filter)

The instrument allows you to read bichromatically with no increase in read time. Use the instrument
bichromatically whenever possible, especially in Rate Mode. Typically, you would us 630 or 580 as the differential
filter for 340 or 405 nm primary wavelengths. In general, select the differential filter whose color is the same as the
chromophore you are reading.

Wavelength Chromophore

340 UV

405 purple

505 blue green

545 emerald green

580 yellow

630 red

23 Human HumaLyzer 2000 User Manual

2.2 Calculation Programs

2.2.1 Absorbance Mode

In Absorbance Mode, the instrument reads and prints sample absorbances at selected wavelengths. The instrument
prints the date and time and the mode of operation. A typical printout is shown below.

1. Press ABS. The display shows:

Select Primary Filter

Key 1 = 340nm

2. The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

3. The display shows:

Select Differential Filt

Key 1 = 340nm

Select the differential wavelength in the same way you chose the primary wavelength and press ENTER. The
absorbance at the differential wavelength will be subtracted from the absorbance at the primary wavelength.
In this way, the repeatability of the reader is improved since any differences such as tube imperfections are
referenced out. Press 0 to read monochromatically. It is recommended that you use the instrument in
bichromatic mode whenever possible.

4. If the instrument is in tube mode, it displays Referencing Air and makes an air reference reading. Do not
attempt to insert a tube or press a key while the reader is referencing air. In Flow Cell mode, the stored water
values are used as a reference.

5. The display then shows:

Absorbance Mode
Read the blank

Insert the blank tube or sample the blank material. See the section Blanking for details.

6. The display shows:

Absorbance Mode
Read sample

Insert the tube or sample the material. See the section Reading samples for details. Repeat this step as
required. You may re-blank at any point by pressing BLANK.

To exit Absorbance Mode and return to the main prompt, press CLEAR twice quickly. The instrument prints
Test Ended and returns to the main prompt.

24
 2.2.2 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. A typical printout for Factor Mode is shown below.

1. Press FACT to select Factor Mode. The display shows:

Ready: Select a Test

Differential Samples Y/N

2. 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 you do not wish to use differential samples, press NO to
continue.

3. The display shows:

Select Primary Filter

Key 1 = 340nm

The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

4. The display shows:

Select Differential Filt

Key 1 = 340nm

Select the differential filter. Select the differential wavelength in the same way you chose the primary
wavelength and press ENTER.

5. The display shows:

Factor Mode
Enter Factor

25 Human HumaLyzer 2000 User Manual

 Type in the factor using the numeric keypad and press ENTER. To clear a mistake and re-enter the factor press
CLEAR once. When you press ENTER, 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 only one decimal place.

6. The display shows:

Factor Mode
Enter Units Code

Enter the units code (0-13) and press YES. See the section Units of Measurement for details. Press UNITS for a
printed menu of units. In the example printout shown above, 0 was selected which printed Conc in the
heading.

7. The display shows:

Factor Mode
Set Ranges Y/N

Press YES to specify a normal and/or linear range, or press NO to continue. If you press YES, enter the values as
described in the section Ranges. The range interpretation will be printed in the far right column.

8. If the instrument is in tube mode, it displays Referencing Air and makes an air reference reading. In Flow Cell
mode, the stored water values are used as a reference.

9. The display then shows:

Factor Mode
Read the blank

Insert the blank tube or sample the blank material. See the sections Blanking and Reading samples for
details.

10. The display shows:

Factor Mode
Read sample

Insert the tube or sample the material. Repeat this step as desired. To exit the mode and return to the main
prompt, press CLEAR twice quickly. The printer outputs Test Ended, and the instrument returns to the main
prompt. You may re-blank at any point by pressing BLANK.

26
 2.2.3 Standard Mode
In 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. A typical printout for standard mode is shown below.

1. Press STND to select Standard Mode. The display shows:

Ready: Select a Test

Differential Samples Y/N

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 you do not wish to use differential samples, press NO to
continue.

2. The display shows:

Select Primary Filter

Key 1 = 340nm

The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

3. The display shows:

Select Differential Filt

Key 1 = 340nm

Select the differential wavelength in the same way you chose the primary wavelength and press ENTER.

4. The display shows:

Standard Mode
Enter Factor

Enter the value of the standard. Type in the value using the numeric keypad on the left, and press ENTER when
you are done. To clear a mistake and re-enter the factor press CLEAR. The standard concentration is then
printed. Note: The instrument will not accept a factor which is more than seven digits, and there can be only
one decimal place.

27 Human HumaLyzer 2000 User Manual

 5. The display shows:

Standard Mode
Enter Units Code

Enter the units code (0-13) and press YES. See the section Units of Measurement for details. Press UNITS for a
printed menu of units. In the example printout shown above, 8 was selected which printed mmol/L in the
heading.

6. The display shows:

Standard Mode
Set Ranges Y/N

Press YES to specify a normal and/or linear range, or press NO to continue. If you press YES, enter the values as
described in the section Ranges. The range interpretation will be printed in the far right column.

7. If the instrument is in tube mode, it displays Referencing Air and makes an air reference reading. In Flow Cell
mode, the stored water values are used as a reference.

8. The display shows:

Standard Mode
Read the blank

Insert the blank tube or sample the blank material. See the sections Blanking and Reading samples for
details.

9. The display shows:

Standard Mode
Read standard

Insert the standard tube or sample the standard material. See the section 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 you specified. The calculated factor will be printed.

10. The display shows:

Standard Mode
Read sample

Insert the tube or sample the material. The concentration will be calculated by multiplying the absorbance by
the factor calculated from the standard. Repeat this step as desired.

To exit Standard Mode and return to the main prompt, press CLEAR twice quickly. The printer outputs Test
Ended, and the instrument returns to the main prompt. You may re-blank at any point by pressing BLANK.

28
 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 by finding the two standard points whose absorbances are the closest above and below the
unknown. The concentration for the unknown sample is then calculated using Beers Law.

A typical printout of Multi-point mode, with an internal graph plot, is shown below:

1. Press PGM to select Multi-point Mode. The display shows:

Ready: Select a Test

Multi % Abs Y/N

2. Press NO to choose between the Multi-Point % Abs Mode and normal Multi-Point Mode. The Multi-point %Abs
mode is identical in calculation to the Multi-Point mode, except that the percent absorbance is calculated and
printed, and the standards must be in descending order. Also, Multi-point % Absorbance does not support
graphing or test reporting. Press YES to select the displayed mode and continue.

29 Human HumaLyzer 2000 User Manual

 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.

3. The display shows:

Select Primary Filter

Key 1 = 340nm

The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

4. The display shows:

Select Differential Filt

Key 1 = 340nm

Select the differential wavelength in the same way you chose the primary wavelength and press ENTER.

5. The display shows:

Multi-Point Mode
Enter Number of Stndrds

Type in the number of standards (1-7) and press ENTER.

6. The display shows:

Multi-Point Mode
Enter Value Stndrd# 1

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 you press ENTER, the value is shown on the printer. Repeat this step for each standard.

7. The display shows:

Multi-Point Mode
Enter Units

Enter the units code (0-13) and press YES. See the section Units of Measurement for details. Press UNITS for a
printed menu of units. In the example printout shown above, 2 was selected which gives g/dL in the
heading.

8. The display shows:

Multi-Point Mode
Set Ranges Y/N

Press YES to specify a normal and/or linear range, or press NO to continue. If you press YES, enter the values as
described in the section Ranges. The range interpretation will be printed in the far right column.

30
 9. If the instrument is in tube mode, it displays Referencing Air and makes an air reference reading. In Flow Cell
mode, the stored water values are used as a reference.

10. The display shows:

Multi-Point Mode
Read the blank

Insert the blank tube or sample the blank material. See the sections Blanking and Reading samples for
details.

11. The display shows:

Multi-Point Mode
Read standard# 1

12. The instrument prompts you to read each of the standards in turn. Insert the standard tube or sample the
standard material. See the section 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, you must repeat the procedure from the beginning.

13. The display shows:

Plot the curve Y/N

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 axis, the concentration along the horizontal axis, and the
sample numbers along the plotted line.

14. The display shows:

Multi-Point Mode
Read sample

Insert the tube or sample the material. The concentration will be calculated as described above. Repeat this
step as desired.

To exit Multi-Point Mode and return to the main prompt, press CLEAR twice quickly. The printer outputs Test
Ended, and the instrument returns to the main prompt. You may re-blank at any time by pressing BLANK.

31 Human HumaLyzer 2000 User Manual

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 you insert the tube or aspirate 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.

You can choose from three variations of the Rate Mode.

Rate by Factor you supply a factor which the instrument uses to calculate the concentration of the
sample at each reading.

Rate by Standard you supply a standard material which the instrument reads and uses to
calculate a factor to obtain the concentration of each sample.

Fixed Time Kinetics you supply either a factor or a standard material as described above, however, readings
are taken only at the beginning and the end of the Read time.

In addition, Rate by Factor and Rate by Standard tests may be performed singly (consecutively) or in batch mode
(simultaneously).

Most rate reactions are temperature dependent. Make sure that the cell temperature control is enabled as
described in the section Temperature Control. You should allow a minimum of 15 minutes for the cell and block to
equilibrate. You should also allow more than 90 seconds for the lamp to warm up, to make sure the photometer
system is as stable as possible. When placing cold or room temperature samples into the incubation block, allow an
additional 5 minutes for the samples to reach 37C.

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, you must first install
the tube gasket supplied.

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.

32
 Rate factors for determining units per liter (U/L) must be derived from the following standard formula:

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

MA x SVmL x LPcm

where:

U/L is units per Liter

A/min is the mean change in absorbance per minute

TV is the total volume of the reaction mixture (in ml)

MA is the molar absorptivity

(the MA of NADH at 340nm, for example, is 6.22 X 10 3)

SV is the sample volume (in ml)

LP is the cuvette light path (in cm)

TF is the temperature factor used to convert the assayed activity to the desired temperature.

A typical Rate Mode printout is shown below. Although the example shows Rate by Factor, the Rate by Standard
and Fixed Time Kinetics are similar. Refer to the sections Rate by Standard and Fixed Time Kinetics.

33 Human HumaLyzer 2000 User Manual

2.2.6 Rate by Factor

1. Press RATE to select Rate Mode. The display shows:

Ready: Select a Test

Batch Mode Y/N

2. Press YES to select Batch Mode, NO to run assays consecutively. The display shows (if not in batch mode; see
the discussion below for batch mode specifics):

Ready: Select a Test

Fixed Time Kinetic Y/N

3. Press NO to continue. Press YES to run Fixed Time Kinetic. See the section below, Fixed Time Kinetics.

4. The display shows:

Ready: Select a Test

Rate Standard or Factor

Press FACT to select Rate by Factor. Press STND to select Rate by Standard. See the section below, Rate by
Standard.

34
 5. The display shows:

Select Primary Filter

Key 1 = 340nm

The bottom line briefly shows each of the possible wavelengths. Press the numeric key that corresponds to the
desired wavelength. To confirm the choice, press ENTER. The selected wavelength is displayed and printed.

6. The display shows:

Select Differential Filt

Key 1 = 340nm

Select the differential wavelength in the same way you chose the primary wavelength and press ENTER.

7. The display shows:

Rate by Factor
Enter Lag Time (Secs)

Enter the lag time in seconds and press ENTER.

8. The display shows:

Rate by Factor
Enter Read Time (Secs)

Enter the read time in seconds and press ENTER. You must enter a read time which is a multiple of 30 seconds.

9. The display shows:

Rate by Factor
Enter Factor

Enter the factor and press ENTER. To clear a mistake and re-enter the factor press CLEAR once. When you press
ENTER, 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 only one decimal place.

10. The display shows:

Rate by Factor
Enter Units

Enter the units code (0-13) and press YES. See the section Units of Measurement for details. Press UNITS for a
printed menu of units.

11. The display shows:

Rate by Factor
Set Ranges Y/N

Press NO to continue. Press YES to enter range values. Refer to the section Ranges for details.

35 Human HumaLyzer 2000 User Manual

12. The display shows (if not in batch mode; see the discussion below for batch mode specifics):

Rate by Factor
Read the blank

Read the blank. Its value is printed.

13. The display shows:

Rate by Factor
Read sample

Insert the tube or sample the material. Also, at any time the display shows Read Sample after you have read a
sample, you can press the PLOT key (9) to plot the reaction curve.

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 0.

14. The display shows:

Rate by Factor
Lag 60 Abs 0.430

The lag time starts at the value you supplied and counts down. The absorbance is continuously displayed.

15. When the lag time has elapsed, the display shows:

Rate by Factor
Read 60 Abs 0.430

The read time starts at the value you supplied and counts down. The instrument beeps as it takes each reading.

16. The final answer is calculated by taking the mean absorbance per minute from all of the intervals. This answer
is printed to the right of the sample as shown in the example printout. If you entered ranges, the range
interpretation is printed to the right of the concentration. Press DATA at any time before reading the next
sample if you wish to print the interval data. The absorbance at 0, 30, and 60 seconds is printed along with the
mean absorbance per minute for each interval (0-30 and 30-60). Using this data, it is possible to gauge the
linearity of the reaction.

If any of the absorbances for the sample are greater than 2.2, a message is printed stating this.

If the absorbance per minute for any of the intervals is less than 0.010, the printer outputs Low Activity and
the display shows:

Rate by Factor
Print Interval Data Y/N

36
 Press YES to print the data. You can examine the data to determine if the sample was not active, or if the
reaction started later in the read time. If the latter is the case you may need to increase the lag time.

If the absorbance per minute for any of the intervals was more than 20% from the mean absorbance per
minute, the display shows:

Rate by Factor
Check Linearity Y/N

Press YES to print the interval data as described above and as shown in Sample #4. Otherwise, press NO.

If either Low Activity or Check Linearity are flagged, you may still print the interval data by pressing the DATA
(7) key.

Refer to the example printout.

In Sample #1 the reaction proceeded normally and the answer was printed.

In Sample #2 a sample with low activity was read.

In Sample #3 the reaction ran to completion and began slowing down. Check Linearity was not selected, so
no interval data was printed.

In Sample #4 the interval data was printed.

17. Go to step 12 for additional samples. To exit Rate Mode and return to the main prompt, press CLEAR twice. The
printer outputs Test Ended, and the instrument returns to the main prompt. You may re-blank at any point by
pressing BLANK.

2.2.7 Rate by Standard

Rate by Standard is very similar to Rate by Factor except that the factor is determined by dividing the given
concentration of the standard by its absorbance. 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 canceled and the instrument returns to the main
prompt.

2.2.8 Fixed Time Kinetics

Fixed Time Kinetics is similar to the other Rate Mode variations. However, instead of basing the final calculation on
the mean absorbance per minute of the sample, the calculation is performed with 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.

37 Human HumaLyzer 2000 User Manual

2.2.9 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, you will be prompted to enter the number of samples. Note that if you are running Rate by
Standard, you must include your standard as one of your samples. The maximum number of samples = 12.

After you read the blank, 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 your 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 you to read your tubes. Read your tubes in
the same uniformly-timed manner in which the samples were added. Assign control labeling when the display is
prompting you to read that sample.

After all samples in the batch have had their initial reading, the display will show the remainder of the read time
countdown. Note that the read time will begin when the initial reading of the first sample is taken. At the end of
the read time, you will be prompted again to read your samples. Again, read your tubes in the same uniformly-
timed manner in which the samples were added. After each tube 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 answer. Note that
interval data and plotting are not available, because the sample does not remain in the cuvette well for the length
of the rate reaction.

After the last sample has been read, the printer will print *** END OF BATCH*** and the Rate Mode will
discontinue.

38
2.3 Stored Tests

The instrument has the capability to store complete test setups in non-volatile memory. This makes 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 you are given the option of reusing the old standard or
reading a new one. There is room for approximately 59 tests, 44 of which have been pre-programmed with tests
compatible with Human assays.

2.3.1 Storing a Test

To save a new test, select a mode and answer all of the configuration questions. When the instrument is ready to
make readings, press STORE. The instrument finds an available test number and saves the setup. The display shows:

Standard Mode
Name the Test Y/N

If you wish to enter a name for the test, press YES. The purpose of the name is simply to help you keep track of the
tests that you have stored. The name is shown on the display while you are running the test, and it is printed when
you print a list of all stored tests. If you choose NO the test will simply be labeled User Test.

If you save the test and then read the blank and/or standards, those values will also be saved along with the test.

After the test has been saved, the instrument continues with normal operation using your selected features.

2.3.2 Recalling a Stored Test

Press MENU. The instrument prompts you to enter the number of the test you wish to run. Use the numeric keys to
enter the test number and press ENTER. The test is recalled and the parameters printed just as if you had selected
the mode and entered all of values manually.

The test name is printed along with the date of the last modification. The modification date is the date the stored
blank and standard values were updated. If there are no stored blank and standards, then the date is when the test
was originally stored.

The blank and curve data is printed and the display shows (for example):

Standard Mode
Use Stored Blank Y/N

Press YES to use the stored blank. The stored value will be used as if it had just been read. If you answer NO, you will
be asked to read a new blank. The display then shows:

Standard Mode
Use last Calibrat. Y/N

39 Human HumaLyzer 2000 User Manual

 Press YES to use the stored factor or standard curve. If you press NO you will be asked to read new values. If you are
recalling a Multi-point % Abs Mode and you choose to use the stored calibration you will be asked to read the first
standard only.

If a stored curve is not used, and there are stored samples in memory, the display shows:

Sample History Will Be

Cleared Continue Y/N

Press NO to abort the test, or press YES to clear the stored samples and continue.

If there was no stored blank or standard curve, or you have chosen not to use them, the values that you read now
will be automatically saved under the recalled test. When you recall the test the next time you will be given the
option to use the stored calibration as described above.

2.3.3 Listing Stored Tests

To print out a list of all of the pre-programmed tests and user tests, press MENU, type in 99, and press ENTER. The
numbers and names of all stored tests are printed.

2.3.4 Deleting a Test

If you find that you no longer need one of the stored tests you may delete it. This makes room for another stored
test. From the main prompt, press DEL. The instrument prompts you for a test number. Type in the number of the
test that you wish to delete and press ENTER. Press YES to confirm the deletion of the test or NO to cancel.

You may also delete any of the pre-programmed tests; however no user tests can be stored in those locations.

2.3.5 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, press EDIT while the instrument is at the main prompt. You will be asked to enter the number of the test
that you wish to edit. Using the numeric keypad, type in the test number and press ENTER.

NOTE: Editing a test will erase any stored blank or standard values for
that test, as well as any stored samples.

All of the test's parameters will be recalled and printed. The display shows:

Standard Mode
Edit Filters Y/N

Press YES to change the filter wavelengths, or NO to continue. The instrument prompts you to select the primary
and differential filters.

40
 The instrument will ask a series of questions. If you press YES, you will be asked to enter the new value just as you
were when the test was originally stored. The questions depend on the mode of the test that you are editing. For
example, if you are editing a factor mode test, you will be asked if you would like to change the factor. If you are
editing a rate test you will be asked if you would like the change the lag and read times.

When you complete the questions, the instrument prints Edit Complete.

NOTE: It is possible to change any of the parameters of a pre-

programmed test. You may need to do this if the assay manufacturer
were to change a required factor, for example. The original pre-
programmed test parameters can always be restored. Refer to the section
Restoring Pre-programmed tests.

41 Human HumaLyzer 2000 User Manual

2.3.6 Pre-Programmed Tests
There are 44 pre-programmed tests for use with Human assays. They are stored in permanent memory. These tests
contain the parameters to run the named assays. Pre-programmed tests are recalled as described above.

A listing of these tests is shown below. Always refer to package inserts when performing assays.

(S) = method with standard (F) = method with factor

42
 2.3.7 Restoring a Test
Because it is possible to edit pre-programmed test parameters, the instrument also provides a means of recalling
the original pre-programmed test. This is called restoring a test. Any changes that you make affect only the
restored copy of the pre-programmed test. The instrument is supplied with all of the pre-programmed tests already
restored.

NOTE: If you restore a pre-programmed test, all blank and standard

values for that test will be deleted, as well as all stored samples for that
test.

To restore a test, press MENU, type 101, and then press ENTER. The display shows:

Ready: Select a Test

Restore A Menu Test Y/N

Press YES to copy just one pre-programmed test. The instrument then prompts you for the test number. Type in the
number of the pre-programmed test that you wish to restore and press ENTER. You will be asked to confirm that
you wish to restore this test. Press YES to restore the test, or press NO to cancel. When you recall the test the
instrument will require that you read new blank and standard values.

If you answer NO to the Restore a Menu Test prompt the display shows:

Ready: Select a Test

Restore Entire Menu Y/N

NOTE: If you restore the entire menu of pre-programmed tests, ALL of the
user tests and ALL of the stored samples will be erased!

If you press YES, all of the pre-programmed tests will be copied to working memory from permanent memory. This
will erase any of the changes you have made to the pre-programmed tests and will delete all of the stored blank
and standard values, as well as all of the user tests and any stored samples.

43 Human HumaLyzer 2000 User Manual

2.4 Auxiliary Menu

Several features are accessed with the Auxiliary menu. The Auxiliary menu is only available when the instrument is at
the main prompt.

Press AUX. The display shows:

Auxiliary Functions
Enter Lab. Name Y/N

The laboratory name is printed at startup, and on reports, to help identify the printed records. Press NO to select the
next feature, or press YES to enter your laboratory name. If you press YES, enter a name as described in the section
Entering Names.

Auxiliary Functions
Label Controls Used Y/N

Press NO to select the next feature, or press YES to enter names for controls 1-4. If you press YES, the display shows:

Enter Control 1 Y/N

Press YES to enter the name for control 1, or press NO to select a different control. Control names are entered as
described in the section Entering Names.

Auxiliary Functions
Print Control Names Y/N

Press NO to return to the main prompt, or press YES to print the control names.

44
3.0 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 Flow Cell

The Flow Cell should be cleaned when the instrument will not be used for an extended period, e.g. overnight, end of
shift, and when storing the Flow Cell. Proper cleaning will help to prevent clogging of the Flow Cell 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 Flow Cell, it is extremely difficult to remove and its presence can affect
test results.

To clean the Flow Cell:

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 Flow Cell 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 Flow Cell for 3 minutes.

5. Purge with at least 15 ml of deionized water.

6. If the Flow Cell is to be removed for storage, purge with air until no more fluid can be seen flowing into the
waste bottle. Otherwise, leave the Flow Cell filled with water.

Material required

[REF] 18222 Flow Cell Cleaner 100 ml

Detergent 0.1%
NaOH < 0.5%
Sodium azid 0.1%

Chemicals
HCl 0.1 N

Disinfectant:
Isopropylalcohol 70% or
Sodium hypochlorite (bleach) 1.5%
7.

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.

45 Human HumaLyzer 2000 User Manual

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 preset calibration is very stable. Absolute
calibration can be verified with the use of NIST filters, or by periodic comparison to a reference instrument that is
known to be calibrated to NIST filters. Calibration may be confirmed using 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 absorbances, the linearity of the
instrument is the more critical indicator of instrument performance. A reduction in linearity with age may be
indicative 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 assay
to cover the entire operational range.

46
 3.2.2 Opening the Instrument
Refer to Figure 3, 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. Move
the instrument forward until the front edge overhangs the work surface. Locate and remove the cover screw from
the underside of the front edge. Gently lift the front of the cover upward, taking care to clear the incubation block
and 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 Flow Cell Luer fitting.

Cover
(raised)

Transformer Main PCB

Pump control
PCB Pump

Incubation
block
Valve

Lamp

Cover screw Photometer

Figure 3 - Instrument Interior

47 Human HumaLyzer 2000 User Manual

48
 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.

1. Place the instrument in tube mode as described in Flow Cell Configuration.

2. 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 4-A, 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.

3. Loosen but do not remove the 2 center lamp connector screws. Remove the lamp by lifting upward.

4. 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 4-B, Lamp Alignment. The lamp filament must be
centered 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.

5. 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 4-C, Spot Alignment. The spot should be small and centered on the oval hole in the cell
block (behind the lens). If the spot is not centered, 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.

6. 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 MENU. Type 186 and press ENTER. The instrument will print the
detected voltage for each filter position. All voltages should be between 2.00 volts and 11.00 volts. If all the
voltages report low, repeat steps 5 and 6.

49 Human HumaLyzer 2000 User Manual

Figure 5 - Flow Cell tubing removal and replacement

50
 3.2.4 Flow Cell Tubing Replacement
The Flow Cell utilizes 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 Flow Cell tubing.

1. Remove the Flow Cell. Unscrew the Luer and lift the Flow Cell out of the read well.

2. Remove the cover screws and lift off the upper Flow Cell cover.

3. Refer to Figure 5. Disconnect the exit tube from the steel tube. Pull the exit tube out through the bulkhead.
Remove the cell insert screws and pull the cell insert and the sample tube out. Remove the sample tube from
the steel tube.

4. Select the long or the short sample tube. The short sample tube must be used when the sample volume is set
to 350 l or less. Carefully press fit the end of the sample tube with the red dot (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 5 for the proper orientation. Do not
reverse the orientation as improper sampling will result. Install the cell body and screws.

5. Feed the exit tube in through the rear of the Flow Cell. Press the exit tube over the steel tube.

3.2.5 Flow Cell Adjustment

The Flow Cell must be adjusted after replacing the Flow Cell tubing, or any time the cell insert is removed or the
adjustment set screw is disturbed.

1. With the instrument on, lift the Flow Cell out of the read well. Do not unscrew the fitting.

2. Press MENU. Type 189 and press ENTER. The instrument will continuously report the detector voltage at 405
nm. Record this value for reference below.

3. Sample deionized water. Visually confirm there are no air bubbles in the cell window.

4. Insert the Flow Cell into the read well until it bottoms out. Note the value displayed. If the displayed value is at
least 1/2 of the value you recorded in step 2, no adjustment is needed.

5. If the displayed value is less than 1/2 of the value in step 2, remove the Flow Cell. Adjust the set screw with the
hex wrench supplied. Turn the set screw 1/4 turn in either direction and go to step 4. If the value in step 4
increases, turn the set screw in the same direction. If it decreases, turn the setscrew in the opposite direction.

6. Repeat steps 4 and 5 until the displayed value is at a maximum. When complete, press CLEAR twice to return to
the main prompt. You must read new water values as described in "Flow Cell Configuration".

51 Human HumaLyzer 2000 User Manual

52
 3.2.6 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.

1. Set the power switch to OFF (O). Open the instrument as described in Opening the instrument. Refer to
Figure 6-A. Locate the valve behind and to the right of the photometer.

2. Refer to Figure 6-B. Pull back the pinch bracket and remove the valve tubing from the valve body.

3. Disconnect the valve tubing from the fittings at both ends.

4. 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.

5. Lower the cover and replace the screw.

53 Human HumaLyzer 2000 User Manual

3.2.7 Waste Bottle Maintenance
The following drawing of the waste bottle is to assist the user in noting any required replacement parts. Part
numbers and descriptions are shown.

Figure 7- Waste Bottle Assembly

54
 3.2.8 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 Flow Cell as described in "Cleaning". Store the instrument using the
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 Flow Cell and allow the Flow Cell and waste bottle to dry overnight.

Place the instrument, Flow Cell, 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
photometric linearity before performing any clinical assays.

55 Human HumaLyzer 2000 User Manual

4. TROUBLESHOOTING

4.1 Flags and Error Messages

4.1.1 Flags
Flags are displayed to alert the operator when certain limits are approached. After displaying the warning the
instrument will continue to function normally.

Flags

***** printed in the concentration field if the absorbance is greater than

2.5 when using tubes, or greater than 3.5 when using the Flow Cell.
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 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!! 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, you should restart the test.

4.1.2 Error Messages

Error messages are displayed when the instrument fails to operate correctly. They are intended to help the operator
locate the problem.

Error Messages

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 Replacement. 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 you will be allowed to continue. Clear the paper
path by gently pulling the obstruction from the printer, and
restarting 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.

56
 Error Messages (Continued)

Waste is Full!!! XX Displayed when the waste material has reached the level sensors.
You have XX samples 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 you empty the waste bottle and
press ENTER.

Sample Area Full! Up to 255 samples are saved for reports. If there is no memory left
for storing samples, this message is displayed. Subsequent samples
are not stored. A message is printed on the report indicating data
may have been lost.

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 frequently, 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.

Canceled Displayed immediately following a filter wheel error to indicate that

the test or mode has ended.

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 Flow Cell is active and no water values were found in memory.
The stored water values have been reset to 0.000. You must read
new water values to ensure correct results. Refer to "Flow Cell
Configuration".

Do Temp Test 210! The stored temperature adjustment has been lost or corrupted. Refer
to the section Restore Calibration Data.

Do ABS Test 212! The stored absorbance adjustment has been lost or corrupted. Refer
to the section Restore Calibration Data.

4.1.3 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 you have selected appropriate wavelengths for the chromophore you are reading. Tubes should have no

57 Human HumaLyzer 2000 User Manual

 bubbles, condensation, scratches or smudges.

4.1.4 Poor linearity

If the instrument is several years old, or has been operated in very humid conditions, you may need new optical
filters. 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.

4.1.5 Erratic readings

One possible source of erratic readings (excessive dither) is trapped air in the Flow Cell. This can be caused by
improper installation of the Flow Cell tubing. Refer to the section "Flow Cell Tubing Replacement". Check the
insertion depth of the Flow Cell tubes. Ensure that a leak-free seal is made.

4.1.6 Lamp failure

The lamp is rated to read over 300,000 tubes, and the lamp saver feature minimizes lamp idle time. Lamp
replacement 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".

4.1.7 Pump runs continuously

Ensure that the waste bottle cap is tight. Ensure that the tubing connections to the instrument rear panel are
secure. Turn only until finger-tight. Do not over-tighten the plastic fittings. If the pump is taking longer to achieve
full vacuum (runs much longer than usual), the exhaust filter is likely clogged and should be replaced. In the event
that the filter gets wet due to a waste bottle spill, the filter must be replaced before continued operation. Contact
your dealer for a replacement filter.

4.1.8 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 Flow Cell. Press PURGE and listen for aspiration. If you
hear air entering the fitting, the valve tubing is clear, but the Flow Cell is blocked. Refer to the sections "Cleaning"
and "Replacing Flow Cell tubing".

If the valve clicks but the pump does not run when you press 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.

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4.2 Restore Calibration Data

4.2.1 Restore Electronic Calibration

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 ABS Set Test 212!

Do Temp Set Test 210!

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 you turn on the instrument, select a mode, or recall a test. 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 block and cell are set to 0.0. Do not enter values other than
those recorded on the calibration label unless absolutely necessary.

Follow these steps to restore the electronic calibration:

1. Shut off the instrument. Remove any tubes or cuvettes from the incubation block and read well. Carefully lift
up the instrument and locate the Calibration Data label on the underside of the unit. There are three values
recorded there: Absorbance, Block Temp, 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 MENU, type in 210, and press ENTER. When the display shows "Block=", type the number that is recorded
under the Block Temp heading on the calibration label, then press ENTER.

5. The display will prompt Cell=. Enter the data from the Cell Temp line of the calibration label.

6. Press MENU, type in 212, and press ENTER. When the display shows

Abs Factor=

Enter the number from the Absorbance line of the calibration label. If the message Adjust out of
Range is displayed, check the values and repeat this step.

7. Press MENU, type in 213, and press ENTER to get a report of the calibration data. The block and 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.

59 Human HumaLyzer 2000 User Manual

4.2.2 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!

You will need to re-enter the filter labels 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
MENU, type in 248, and press ENTER. You will be prompted:

Change Filter Names

Key 7 = ??? nm

Type in the wavelength for Key 7 that is printed on the label and press ENTER. Repeat for Key 8. You may use 000
for unused filter positions. Press CLEAR twice to return to the main prompt. Note that, if you enter values for Key 7
and Key 8 when there are no filters present, the filters will be flagged as low when Self Check is run.

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