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User Manual

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Cat.-No.: 18391
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Humalyzer 2000
Table of Contents
User's Manual
I. Introduction .......................................... 2
Warnings and Precautions .................... 2 Auxiliary Menu........................................ 4 8
Intended Use ............................................ 3 Self-Check .............................................. 4 8
Environmental Conditions ...................... 3 Flags and Error Messages ................... 4 9
Description ................................................ 4 Flags ................................................. 4 9
Specifications ........................................... 5 Error Messages ............................... 4 9
Setup ......................................................... 7 III. Cleaning and Maintenance ........... 5 1
Unpacking .......................................... 7 Cleaning .................................................. 5 1
Preparation ........................................ 9 Exterior ............................................. 5 1
Checkout ................................................. 1 1 Flowcell ............................................. 5 1
Getting Started ....................................... 1 3 Waste bottle ..................................... 5 2
II. Operating Instructions ...................... 1 5 Maintenance ........................................... 5 3
Keypad Description ........................ 1 5 Calibration and Linearity ................ 5 3
Flowcell Configuration .................... 1 7 Opening the Instrument ................. 5 3
Temperature Control ...................... 1 8 Lamp replacement .......................... 5 6
Lamp Warmup and Lamp Saver .. 1 8 Flowcell Tubing Replacement ....... 5 8
Printers ............................................. 1 9 Flowcell Adjustment ........................ 5 8
Serial Port ........................................ 1 9 Valve tubing replacement .............. 6 0
Date Format ..................................... 2 0 Waste Bottle Maintenance ............ 6 1
Set Date and Time .......................... 2 0 Storage .................................................... 6 2
Units of Measurement .................... 2 1 Troubleshooting ..................................... 6 3
Rang e s ............................................. 2 2 Incorrect control readings .............. 6 3
Entering Names .............................. 2 3 Poor linearity .................................... 6 3
Controls ............................................ 2 3 Erratic readings ............................... 6 3
Reports ............................................. 2 3 Lamp failure ..................................... 6 3
Blanking ............................................ 2 5 Pump runs continuously ................ 6 3
Reading Samples ............................ 2 5 No sampling ..................................... 6 3
Bichromatic Operation (Differential ........................................................... 6 4
Filter) ................................................. 2 5 Restore Calibration Data ............... 6 4
Absorbance Mode ................................. 2 6 Restore Filter Labels ...................... 6 5
Factor Mode ........................................... 2 8 Coagulation Accessories ...................... 6 6
Standard Mode ...................................... 3 0
Multi-point Mode .................................... 3 3
Rate Mode .............................................. 3 7
Rate By Factor ................................ 3 8
Rate By Standard ............................ 4 1
Fixed Time Kinetics ........................ 4 2
Batch Rate Mode ............................ 4 2
Stored Tests ........................................... 4 3
Storing a test ................................... 4 3
Recalling a stored test ................... 4 3
Listing stored tests .......................... 4 4
Deleting a test ................................. 4 4
Editing a test .................................... 4 4
Pre-Programmed Tests ................. 4 6
Restoring a Test .............................. 4 7

Rev. D.1, June 1997


Rev. D 1
I. Introduction
Warnings and Precautions
WARNING

Some diagnostic assays utilize material which is


potentially biohazardous. Always wear protective ap-
parel 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, im-


mediately 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.

2 Rev. D
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.

Environmental Conditions
This instrument is intended for indoor use at temperatures between 15°C and 35°C 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.

Rev. D 3
Description
The instrument is a general-purpose, bichromatic photometer system with six available
wavelengths and 37°C incubation. Two additional wavelengths are optional. A
removable flowcell installs in the read well to provide extremely rapid fluid sampling with
low carryover. A built-in vacuum pump and an external autoclavable waste bottle with
level sensing are supplied standard. When the flowcell 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 37°C.

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.

4 Rev. D
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

Cuvette
Type Flow-through
Material 316 stainless, borosilicate windows
Geometry Cylindrical, 2.3 mm dia x 5 mm +/- 0.05 mm
Illuminated Volume 21 µl
Minimum Read Volume 250 µl
Aspiration/Purge Vacuum pump at 18 cm of Hg
Valve Silicone pinch type

Rev. D 5
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

6 Rev. D
Setup
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 flowcell 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

Flowcell Rectangular object with square extension, in plastic


box

Spare tubing and tool kit


Valve tubing Silicone tube
Sample tube, long Teflon tube, swaged end, for sample vol. >350µl
Sample tube, short Teflon tube, swaged end, for sample vol. ­ 350µl
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

Owner’s Manual This document.

Rev. D 7
Printer
paper
Printer roll cover
Rear dress panel

Keypads

Display

Incubation
block

Sample Exit tube


tube Sample bar READY
Flowcell
indicator
Waste Sensor
bottle wires
Exhaust
filter
Printer paper feeds Vacuum
toward front of fitting
instrument (blue)
Sensor
Waste lead
fitting
(white)
Sensor
Parallel port
jack

Power switch
Vacuum
fitting
(blue)

Waste
fitting
Bottle Fan Power Voltage
(white)
strap outlet inlet select
Serial switch
port

Figure 1. Parts and Controls

8 Rev. D
Preparation
Complete this procedure to prepare the instrument for operation.

1. 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.

2. 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.

2. 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.

3. 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 overtighten.

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

5. 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.

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

7. 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.

Rev. D 9
8. 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.

9. Install the flowcell in the read well so that the sample tube is toward the front and
the exit tube is toward the rear. Press the flowcell 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 overtighten.

10. 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.

11. 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.

12. 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.

13. Locate the bottle of flowcell 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 flowcell. Remove the bottle of cleaning solution and
replace the cap. Allow the solution to remain in the flowcell for 3 minutes.

14. 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 flowcell for 3 minutes.

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

10 Rev. D
Checkout
Follow this procedure to verify that the instrument is ready for use.

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

Visually confirm the following items:

• Waste bottle is connected to the correct fittings.


• Sensor lead is plugged in.
• Waste bottle is empty.
• Waste bottle cap is tight.
• Power cable is plugged into rear of unit and into AC outlet.
• Flowcell is fully seated in read well and Luer fitting is connected. (If flowcell 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
Flowcell 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 37°C.

Rev. D 11
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, 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.

12 Rev. D
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 instrument’s 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.

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)
Updated: 01/01/94 Name of test
01/01/94 :G 14:55 Date last updated/modified
Standard Mode Current date, software revision, time
Sample Volume=500uL Operating mode
Wavelngths=340 630nm Aspiration volume (indicates Flowcell Mode)
Standard#1= 100.0 Filter wavelengths (primary/differential)
Norms: 75.0to 115.0 Standard # 1 is equal to 100.0 units
Linear: to 700.0 The normal range is 75 to 115 units
-------------------- 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

Rev. D 13
NOTE

The instrument automatically purges with air after making


the absorbance readings. Be sure to remove the sample
container after the instrument beeps.

is below the 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, 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

• 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 Rev. D
II. Operating Instructions
Keypad Description
Refer to Figure 1., Parts and Controls and Figure 2., 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.

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
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 flowcell
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 flowcell
MENU Recall stored tests
READ Select characters from list

Rev. D 15
STND RATE FACT
YES Lamp STORE EDIT DEL TEMP
1 2 3

ABS PGM %ABS


Paper CELL VOL FILT UNITS
4 5 6

DATA AUX PLOT SelfCk TIME PRNT PURGE


Clear
7 8 9 + - : /

BLANK
NO ENTER MENU READ
0

Figure 2. Keypad Layout

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

Press CELL to configure the flowcell settings. The display shows:

Flowcell Settings
Flowcell Active Y/N

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

Flowcell 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:

Flowcell 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 µl. 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 µl or less,


you must also install the shorter sample tube (3.8 cm)
provided in the tubing kit. Refer to the section “Flowcell
tubing replacement”.

The display then shows:

Flowcell 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 flowcell. These reference values
are stored in non-volatile memory. The instrument uses the stored values whenever the
flowcell is active, until new values are read.

Rev. D 17
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 37°C by the software.
A small ‘h’ will appear after the temperature when the heating element for the particular
incubator is turned on.

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 flowcell to an
instrument that has already reached temperature equilibration (about 15 minutes from
power-on), allow at least 5 minutes for the cuvette or the flowcell to equilibrate after
insertion.

To view the temperature at any time, press TEMP. The prompt to turn cell temperature

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.

18 Rev. D
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

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 printer’s memory can hold), the instrument’s display will prompt you
to “Retry.” You may Retry to continue printing after the printer has emptied its buffer.

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 pinout.
The data format is 2400 baud, 8 bits, 1 stop bit, and no parity. Contact your distributor
to obtain a serial printer cable.

The pinout for the serial port is:

1 GND
2 TX
3 RX/DTR
4-9 NC

Rev. D 19
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, then press ENTER.


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

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.

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.

20 Rev. D
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 meq/dL
1 g/L 8 mmol/L
2 g/dL 9 mcmo/L
3 mg/dL 10 IU/mL
4 ug/L 11 ukat/L
5 ug/dL 12 umol/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.

Rev. D 21
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.

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.

22 Rev. D
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.

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”.

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

Rev. D 23
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, 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.

24 Rev. D
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 Flowcell
mode, it is relative to the stored water values. In this way the user can evaluate the
suitability of the blank before using it.

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.

Using the flowcell:


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
flowcell and drawn into the waste bottle at the rear of the instrument. When the
instrument is ready for the next sample, the READY indicator lights, and the
instrument prompts you to read the next sample.

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 use 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

Rev. D 25
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 flowcell 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.

26 Rev. D
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.

Rev. D 27
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

28 Rev. D
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 flowcell 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.

Rev. D 29
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 Beer’s 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.

30 Rev. D
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.

5. The display shows:

Standard Mode
Enter Units Code

Enter the units code (0-13) and press YES. See the section “Units of Measure-
ment” 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 flowcell 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.

Rev. D 31
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.

32 Rev. D
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 Beer’s 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.

Rev. D 33
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.

34 Rev. D
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.

9. If the instrument is in tube mode, it displays “Referencing Air” and makes an


air reference reading. In flowcell mode, the stored water values are used as
a reference.

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

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.

12. 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...

Rev. D 35
The plot shows the absorbance along the vertical axis, the concentration
along the horizontal axis, and the sample numbers along the plotted line.

13. 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.

36 Rev. D
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 37°C.

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.

Rev. D 37
Rate factors for determining units per liter (U/L) must be derived from the following standard
formula:

U/L = ÐA/min. x 1000 x TVmL x TF


MA x SVmL x LPcm
where:
U/L is units per Liter
ÐA/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”, below.

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”.

5. The display shows:

Select Primary Filter


Key 1 = 340nm

38 Rev. D
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.

Rev. D 39
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.

13. 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.

14. 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.

15. 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.

40 Rev. D
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

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 neither 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.

16. 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.

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

Rev. D 41
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.

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.

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.

42 Rev. D
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.

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.

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

Rev. D 43
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

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.

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.

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.

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.

44 Rev. D
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.

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” .

Rev. D 45
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.

1)Albumin
2)Bilirubin DCA
3)Bilirubin DCA
4)Bilirubin
5)Calcium
6)Cholesterol (S)
7)Cholesterol (F)
8)Creatinine
9)Glucose GOD-PAP
10)Glucose HK (S)
11)Glucose HK (F)
12)Glucose HK Hemol
13)Hemoglobin
14)Iron (S)
15)Iron (F)
16)Magnesium
17)Phosphorus
18)Potassium
19)Total Protein (S)
20)Total Protein (F)
21)Triglyceride (S)
22)Triglyceride (F)
23)Urea
24)Uric Acid (S)
25)Uric Acid (F)
26)Acid Phosphatase
27)Alk Phos
28)Amylase CT EPS
29)Amylase Liquid
30)CK-NAC
31)CK-MB Micro Meth
32)Gamma-GT
33)GOT
34)GPT
35)LDH
36)AA1 (APOA1)
37)AB1 (APOB)
38)LPA
39)RF
40)ASO
41)CRP
42)IGA

(S) = method with standard


(F) = method with factor
Always refer to package inserts when performing assays.

46 Rev. D
43)IGG
44) IgM
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, 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.

Rev. D 47
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.

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.

48 Rev. D
Flags and Error Messages
Flags
Flags are displayed to alert the operator when certain limits are approached. After
displaying the warning the instrument will continue to function normally.

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


greater than 2.5 when using tubes, or greater than 3.5
when using the flowcell. To obtain an accurate absor-
bance and/or concentration for this sample it is necessary
to further dilute the sample(s), or dilute the specimen(s)
and rerun the assay.

>10**7 is printed in the concentration column when the result of


the concentration is greater than 7 digits and cannot be
printed in the concentration column

—CURVE INVALID!!— is printed in the Multi-point mode when a curve cannot be


drawn between the standards that were read. An “X” will
be printed after the standard which causes the curve to be
invalid. Check to make sure the standards were in
decreasing order of absorbance in the Multi-point % Abs,
or in increasing order if in Multi-point Mode. Since this
invalidates the results, you should restart the test.
Error Messages
Error messages are displayed when the instrument fails to operate correctly. They are
intended to help the operator locate the problem.

Lamp Failure The lamp does not appear to be sufficiently illuminated.


This can be caused by either lamp failure or degraded
filters. See the section “Lamp 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.

Waste is Full!!! XX is 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.

Rev. D 49
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 been 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 flowcell 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 "Flowcell 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”.

50 Rev. D
III. Cleaning and Maintenance
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.

Flowcell
The flowcell should be cleaned when the instrument will not be used for an extended
period, e.g. overnight, end of shift, and when storing the flowcell. Proper cleaning will
help to prevent clogging of the flowcell tubing and valve tubing. Cleaning is extremely
important to obtaining accurate, repeatable results. If reagent, serum, or other
proteinaceous fluid is allowed to dry in the flowcell, it is extremely difficult to remove and
its presence can affect test results.

To clean the flowcell:

1. Purge with air for at least 5 seconds.

2. Aspirate a small amount of flowcell cleaning solution. Allow the solution to


remain in the flowcell for 3 minutes.

3. Aspirate 15 ml of distilled water then purge with air for 5 seconds.

4. Aspirate 0.1N hydrochloric acid (HCl). Allow the solution to remain in the
flowcell for 3 minutes.

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

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

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.

Rev. D 51
Maintenance
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.

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 flowcell Luer fitting.

52 Rev. D
Fan

Cover
(raised)

Main PCB
Transformer
Pump
Pump
control
PCB

Valve
Incubation
block
Lamp

Cover Photometer
screw

Figure 3. Instrument Interior

Rev. D 53
Horizontal
Lamp adjustment Luer fitting
Lamp bracket screw
Vertical
adjustment
screw
Valve tubing

(2) Lamp connector


screws
Filter wheel
motor

Figure 4-A. Lamp Removal and Adjustments

Not
centered Not
parallel

Figure 4-B. Lamp Alignment

Figure 4-C. Spot Alignment

54 Rev. D
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 “Flowcell 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.

Rev. D 55
(top view)

Bulkhead Sample
Exit tube Bulkhead
tube
(side view)

Cell body

Cell insert
screw

Cell window
Steel
Cell insert tubes

Adjustment set screw

Figure 5. Flowcell tubing removal and replacement

56 Rev. D
Flowcell Tubing Replacement
The flowcell 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 flowcell tubing.

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

2. Remove the cover screws and lift off the upper flowcell 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 µl 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 flowcell.Press the exit tube over the
steel tube.

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

1. With the instrument on, lift the flowcell 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 flowcell 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 flowcell.
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 "Flowcell Configuration".

Rev. D 57
Photometer Valve Valve tubing

Figure 6-A. Valve location

Valve body

Valve Pinch bracket


tubing

Solenoid

Figure 6-B. Valve Tubing Replacement

58 Rev. D
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.

Rev. D 59
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.

WASTE BOTTLE ASSY. (ITEM 19. 18320/05)

CAP ASSEMBLY
(W/GASKET, VOL SENSORS,
AND TUBE FITTINGS)
18320/22

VACUUM BOTTLE, 500 ML


(W/ STANDARD, UNALTERED CAP)
18320/25

FILTER,
HYDROPHOBIC
"INLET"
(18320/15)
SIDE

SENSOR CABLE ASSEMBLY


VACUUM
(CONDUCTOR CABLE WITH BOTH
LINE, WITH
END CONNECTORS)
BLUE CAP
18320/28

WASTE LINE,
WITH NATURAL
CAP

WASTE BOTTLE TUBING ASSEMBLY


(W/LUERS AND PVC TUBING,
W/O FILTER)
18320/29

Figure 7. Waste Bottle Assembly

60 Rev. D
Storage
The instrument may be stored under the following recommended environmental
conditions:

Temperature -10 to 50°C


Humidity Less than 80% relative humidity, non-condensing.

Before storing the instrument, clean the flowcell as described in "Cleaning", Store using
original packaging if possible. Perform the following steps before storing.

• Set the power switch to OFF (O) and remove the power cord.

• Disconnect tubing and the sensor lead from the rear panel. Unhook the waste
bottle strap and remove the waste bottle. Remove the waste bottle cap.

• Empty the waste bottle and autoclave, or disinfect with a 1.5% chlorine bleach
solution.

• Remove the flowcell and allow the flowcell and waste bottle to dry overnight.

• Place the instrument, flowcell, waste bottle in the original packaging material.

When returning the instrument to service from storage, it is recommended that functional
tests be performed as if setting up the instrument for the first time. It is especially important
to verify sample volume accuracy and photometric linearity before performing any clinical
assays.

Rev. D 61
Troubleshooting
Incorrect control readings
Check that the procedures and materials used were valid. Turbid or contaminated
reagents may affect absorbance readings. Reading reference dyes can be very helpful
in separating instrument problems from reagent problems. Be sure that you have
selected appropriate wavelengths for the chromophore you are reading. Tubes should
have no bubbles, condensation, scratches or smudges.

Poor linearity
If the instrument is several years old, or has been operated in very humid conditions,
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.

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

Lamp failure
The lamp is rated to read over 300,000 tubes, and the lamp saver feature 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".

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.

No sampling
If you can hear the valve cycle, but no sample is drawn up, the valve tubing may be
blocked. Press and hold PURGE several times. Disconnect the Luer fitting at the rear
of the flowcell. Press PURGE and listen for aspiration. If you hear air entering the fitting,
the valve tubing is clear, but the flowcell is blocked. Refer to the sections "Cleaning" and
"Replacing Flowcell tubing".

If the valve clicks but the pump does not run when 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).

62 Rev. D
Gently pull the tubing slightly to break the seal. See the section on “Valve Tubing
Replacement” for a diagram and more information about the valve tubing.

Restore Calibration Data


Each unit is electronically calibrated at the factory. The calibration values are entered
by the keyboard and stored in non-volatile memory. The instrument will not accept a
change greater than +/- 10% (.900-1.100) for the absorbance factor, nor will it accept
a temperature offset change greater than +/- 2.5°C. 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.
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.

Rev. D 63
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.

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.

64 Rev. D
Coagulation Accessories
COAG 2000 (P/N 18301)
The COAG 2000 Accessory is available to enable the Humalyzer 2000 to perform
coagulation assays, including Fibrinogen, PT Quick Test, and aPTT, as well as general clot
time assays. An incubator adapter is included, to allow easy modification for coagulation
tube incubation. This kit contains everything required to modify most Humalyzer 2000
instruments for coagulation assays. If your instrument has serial number 2500-1356 or
lower, you will also need the COAG 2000 Retrofit Kit (P/N 18302).

COAG 2000 Retrofit Kit (P/N 18302)


The COAG 2000 Retrofit kit is used in conjuction with the COAG 2000 Accessory for
Humalyzer 2000 instruments with serial number 2500-1356 or lower. This is required to
further adapt the incubators for use with both coagulation assays and tubes.

COAG 2000 Stir bars (P/N 18301/6)


The stir bars fo r the COAG 2000 Accessory come in packages of 100 pieces per container.

COAG 2000 Stir bar dispenser tool (P/N 18301/7)


The stir bar dispenser tool is available to assist you in dispensing the COAG 2000 stir bars
individually from the container (P/N 18301/6)

Please contact your distributor if you have any questions, or to place an order.

Rev. D 65
Human
Gesellschaft für Biochemica
und Diagnostica mbH
Max-Planck-Ring 21 ! D-65205 Wiesbaden
Germany
Telefon: +49 6122 9988 0
Telefax: +49 6122 9988 100

eMail: human@human.de
Internet: http://www.human.de

01/2004-04

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