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Operator’s Manual
© 2011 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
, , , , , BeneView,
WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in
China and other countries. All other trademarks that appear in this manual are
used only for informational or editorial purposes. They are the property of their
respective owners.
All information contained in this manual is believed to be correct. Mindray shall not
be liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this
product, only if:
the electrical installation of the relevant room complies with the applicable
national and local requirements; and
i
WARNING:
It is important for the hospital or organization that employs this
equipment to carry out a reasonable service/maintenance plan.
Neglect of this may result in machine breakdown or personal injury.
NOTE:
This equipment must be operated by skilled/trained clinical
professionals.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product or the
use of parts or accessories not approved by Mindray or repairs by people other than
Mindray authorized personnel.
Malfunction of the instrument or part whose serial number is not legible enough.
ii
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
iii
iv
Preface
WARNING:
The Chemistry Analyzer is to be operated only by clinical
professionals, doctors or laboratory experimenters trained and
authorized by our company or our authorized distributors.
1 System Description
2 Installation
3 Basic Operations
4 Advanced Operations
5 Maintenance
6 Troubleshooting
7 Calculation Methods
Appendix A Specifications
Appendix B Supplies
Appendix C Index
1
A screen field or value, such as Method.
Safety Symbols
This chart explains the symbols used in this manual.
Serial Number
Manufacturer
Date of Manufacture
2
Biohazard Warning: risk of potentially biohazardous infection
ON (POWER)
OFF (POWER)
Graphics
All graphics, including screens and printout, are for illustration purposes only and
must not be used for any other purpose.
3
Safety Precautions
Observe the following safety precautions when using the Chemistry Analyzer.
Ignoring any of these safety precautions may lead to personal injury or equipment
damage.
WARNING:
If the system is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
WARNING:
When the POWER is on, users must not open the rear or side cover.
Spillage of reagent or sample on the analyzer may cause equipment
failure and even electric shock. Do not place sample and reagent on
the analyzer. In case of liquid ingression, shut off the power supplies
immediately, remove the spillage and contact our Customer Service
Department or your local distributor.
WARNING:
Do not touch such moving parts as sample probe, reagent probe and
mixing bar, when the analyzer is in operation.
Do not put your finger or hand into any open part when the analyzer is
in operation.
If you want to replace the photometer lamp, first switch off the POWER
and then wait at least 15 minutes for the lamp to cool down before
touching it. Do not touch the lamp before it cools down, or you may get
burned.
Eye Protection
WARNING:
Light sent by the photometer lamp may hurt your eyes. Do not stare
into the lamp when the analyzer is in operation.
Preventing Infection
BIOHAZARD:
Inappropriately handling samples may lead to biohazardous infection.
Do not touch the sample, mixture or waste with your hands. Wear
gloves and lab coat and, if necessary, goggles.
In case your skin contacts the sample, follow standard laboratory
safety procedure and consult a doctor.
4
Handling Reagents and Wash Solution
WARNING:
Reagents and wash solution are corrosive to human skins. Exercise
caution when using the reagents. In case your skin or clothes contact
the reagents, wash them off with soap and clean water. In case the
reagents spill into your eyes, rinse them with much water and consult
an oculist.
BIOHAZARD:
Dispose of the waste in accordance with your local or national
guidelines for biohazard waste disposal and consult the manufacturer
or distributor of the reagents for details.
WARNING
Materials of the analyzer are subject to contamination regulations.
Dispose of the waste analyzer in accordance with your local or
national guidelines for waste disposal.
WARNING:
Ethanol is flammable substance around the analyzer. Please exercise
caution while using the ethanol.
5
Precautions on Use
To use the analyzer safely and effectively, pay attention to the following operation
notes.
Intended Use
WARNING:
The Chemistry Analyzer is a chemistry system that is designed for the
in vitro quantitative determination of clinical chemistries in serum,
plasma, urine, CSF and other samples. Please consult us first if you
want to use the system for other purposes.
To draw a clinical conclusion, please also refer to the patient’s clinical
symptom and other test results.
Operator
WARNING:
The system is to be operated only by clinical professionals, doctors or
laboratory experimenters trained and authorized by our company or
our authorized distributors.
Environment
CAUTION:
Please install and operate the analyzer in an environment specified by
this manual. Installing and operating the analyzer in other environment
may lead to unreliable results and even equipment damage.
To relocate the analyzer, please contact our Customer Service
Department or your local distributor.
CAUTION:
Electromagnetic noise may interfere with operation of the analyzer. Do
not install devices generating excessive electromagnetic noise around
the analyzer. Do not use such devices as mobile phones or radio
transmitters in the room housing the analyzer. Do not use other CRT
displays around the analyzer.
The analyzing unit is designed and tested to CISPR 11 Class A. In a
domestic environment it may cause radio interference, so you may
need to take measures to mitigate the interference.
Do not use other medical instruments around the analyzer that may
generate electromagnetic noise to interfere with their operations.
6
NOTE:
It is the manufacturer's responsibility to provide equipment
electromagnetic compatibility information to the customer or user.
It is the user's responsibility to ensure that a compatible
electromagnetic environment for the equipment can be maintained in
order that the device will perform as intended.
CAUTION:
Operate the system strictly as instructed by this manual. Inappropriate
use of the analyzer may lead to unreliable test results or even
equipment damage or personal injury.
Before using the system for the first time, run the calibration program
and the QC program to make sure it is in a proper state.
Be sure to run the QC program every time you use the system,
otherwise the result man be unreliable.
Do not open the sample disk or reagent disk cover when the analyzer
is operating.
The RS-232 port on the analyzing unit is to be used for connection
with the operation unit only. Do not use it for other purposes. Only use
the supplied cable for the connection.
The operation unit is a personal computer with the analyzer control
system installed. Installing other software or hardware on this
computer may interfere with the system operation. Do not run other
software when the system is working.
Do not use this computer for other purposes. Inappropriate use of this
computer may introduce computer virus, which may spread through
floppy disks, software or network, into the system.
Do not touch the display, mouse or keyboard with wet hands or hands
with chemicals on them.
Don’t place the POWER to ON again within 10 seconds since placing
it to OFF, otherwise the system may enter the protection status. If it
does so, place the POWER to OFF and place it to ON again.
7
Maintaining the System
CAUTION:
Maintain the system strictly as instructed by this manual. Inappropriate
maintenance may lead to equipment damage or personal injury.
To wipe off dust from the analyzer surface, use a soft, clean and wet
(not too wet) cloth, soaked with soap water if necessary, to clean the
surface. Do not use such organic solvents as ethanol for the cleaning.
After cleaning, wipe the surface dry with dry cloth.
Switch off all the powers and disconnect the power plug before
cleaning. Take necessary measures to prevent water ingression into
the system, otherwise it may lead to equipment damage or personal
injury.
Replacements of such major parts as the photometer, sample probe,
reagent probe, mixing bar and syringe plungers must be followed by a
calibration.
Samples
CAUTION:
Use serum samples that are completely separated from blood clots or
urine samples that are free from suspended matter. If fibrin exists in
the serum samples or suspended matter exist in the urine samples,
the sample probe may be blocked.
Medicines, anticoagulants or preservative in the samples may lead to
unreliable test results.
Hemolysis, jaundice or chylomicron in the samples may lead to
unreliable test results, so sample blanks are recommended
Store the samples properly. Improper storage may change the
compositions of the samples and lead to unreliable results.
Sample volatilization may lead to unreliable results. Do not leave the
sample open for too long.
Not all the tests the reagents claim capable of analyzing can be
analyzed on the analyzer. Consult the reagent suppliers for detailed
information.
Certain samples need to be processed before being analyzed by the
analyzer. Consult the reagent suppliers for details.
The analyzer has a specific requirement on the minimum sample
volume. Refer to this manual for the proper sample volume.
Load the sample to proper tube positions on the sample disk before
the analysis begins; otherwise you will not obtain correct results.
8
Reagents, Calibrators and Controls
CAUTION:
Use proper reagents, calibrators and controls in the analyzer.
Select appropriate reagents according to the performance
characteristics of the analyzer. Consult the reagent supplier or our
authorized distributor for details when you are not sure about your
reagent choice.
Store and use the reagents, calibrators and controls strictly as
instructed by the suppliers. Otherwise, you may not obtain reliable
results or the best performance of the analyzer.
Perform calibration after changing the reagents. Otherwise, you may
not obtain reliable results.
Contamination among reagents by carryover may lead to unreliable
test results. Consult the reagent supplier for details.
Setting up System
CAUTION:
You need to set up the analyzer strictly as instructed by this manual
before using it. To define such parameters as sample volume, reagent
volume and wavelength, consult instructions of reagents.
Backing Up Data
NOTE:
The analyzer automatically backs up the data to the built-in hard disk.
However, data loss is still possible due to mis-deletion or physical
damage of the disk. We recommend you regularly back up the data to
such medium as CDs.
NOTE:
Refer to their user’s manuals for details.
External Equipment
WARNING:
External equipment connected to the analogue and digital interfaces
must be complied with the relevant Safety and EMC standards (e.g.,
IEC 60950 Safety of Information Technology Equipment Standard and
CISPR 22 EMC of Information Technology Equipment Standard
(CLASS B)). Any person, who connects additional equipment to the
signal input or output ports and configures an IVD system, is
responsible for ensuring that the system work normally and complies
with the safety and EMC requirements. If you have any problem,
consult the technical services department of your local representative.
9
10
Contents
Intellectual Property Statement ............................................................................................... i
Responsibility on the Manufacturer Party ............................................................................... i
Warranty..................................................................................................................................ii
Preface.......................................................................................................................................... 1
Who Should Read This Manual ............................................................................................. 1
What Can You Find in This Manual........................................................................................ 1
Conventions Used in This Manual ......................................................................................... 1
Safety Precautions ................................................................................................................. 4
Precautions on Use................................................................................................................ 6
Contents ........................................................................................................................................ i
i
3.4.1 Exiting the Operating Software............................................................. 3-7
3.4.2 Shutdown.............................................................................................. 3-7
3.4.3 Checking after Shutdown ..................................................................... 3-7
ii
5.3.5 Washing Waste Tank .......................................................................... 5-16
5.3.6 Cleaning Sample Disk/Compartment ................................................. 5-17
5.3.7 Cleaning Reagent Disk/Compartment................................................ 5-18
5.3.8 Cleaning Panel of Analyzing Unit ....................................................... 5-19
5.4 Monthly Maintenance ........................................................................................ 5-19
5.4.1 Cleaning Wash Well of Sample Probe ............................................... 5-19
5.4.2 Cleaning Wash Well of Reagent Probe.............................................. 5-20
5.4.3 Cleaning Wash Well of Mixing Bar ..................................................... 5-21
5.4.4 Cleaning Sample Probe Rotor............................................................ 5-22
5.4.5 Cleaning Reagent Probe Rotor .......................................................... 5-22
5.4.6 Cleaning Mixing Bar Rotor ................................................................. 5-23
5.5 Maintenance Every Six Months ......................................................................... 5-24
5.5.1 Washing Dust Screens ....................................................................... 5-24
5.5.2 Replacing Filter Assembly .................................................................. 5-24
5.6 Irregular Maintenance........................................................................................ 5-25
5.6.1 Unclogging Sample Probe.................................................................. 5-25
5.6.2 Unclogging Reagent Probe ................................................................ 5-33
5.6.3 Replacing Sample Probe.................................................................... 5-40
5.6.4 Replacing Reagent Probe .................................................................. 5-40
5.6.5 Replacing Mixing Bar ......................................................................... 5-41
5.6.6 Replacing Plunger Assembly of Sample/Reagent Syringe ................ 5-44
5.6.7 Removing Air Bubbles ........................................................................ 5-47
5.6.8 Replacing Lamp ................................................................................. 5-48
5.6.9 Replacing Electrode (optional) ........................................................... 5-51
5.6.10 Replacing Reagent Module (optional)................................................ 5-52
5.6.11 ISE Unit Storage (optional)................................................................. 5-53
5.6.12 ISE Unit Re-activation (optional) ........................................................ 5-54
5.7 Maintenance Log ............................................................................................... 5-54
6 Troubleshooting................................................................................................................ 6-1
6.1 Classification of Error Messages ......................................................................... 6-1
6.2 Corrective Measures ........................................................................................... 6-4
6.2.1 Corrective Measures for General Errors .............................................. 6-4
iii
A.11 ISE Module (optional) ..........................................................................................A-3
iv
1 System Description
This chapter includes the following two sections:
Hardware Introduction
Software Introduction
The Chemistry Analyzer is a chemistry system that is designed for the in vitro
quantitative determination of clinical chemistries in serum, plasma, urine, CSF and
other samples.
NOTE:
Not all the parameters the reagents claim capable of testing can be
tested on the analyzer. Consult the reagent suppliers for detailed
information.
Figure 1-1 Overview of the analyzing unit and the operation unit
1-1
The analyzing unit consists of the following major parts:
Mixer assembly
Reagent dispenser
Sample dispenser
Mixer wash well
Reagent probe wash
Sample probe
well
wash well
Reagent disk Sample disk
Reaction cuvette
compartment
1-2
Figure 1-3 Front view
Upper cover
Analyzing Unit
Power
Middle door Main Power
Mounting holes
Lower door
Connect the power cord to the power plug shown in Figure 1-3.
RESET
COM
D-SENSOR WASTE
DEIONIZED W-SENSOR
WATER
1-3
DEIONIZED WATER: If you choose to feed deionized water from the back of the
analyzing unit, pull the deionized water tubing into the unit from here;
D-SENSOR: If you choose to feed deionized water from the back of the analyzing
unit, pull the cable of the deionized water level detector into the unit from here;
WASTE: If choose to discharge waste from the back of the analyzing unit, pull the
waste tubing out of the unit from here;
W-SENSOR: If you choose to discharge the waste from the back of the analyzing
unit, pull the cable of the waste level detector out of the unit from here;
COM: It is the serial port for communication with the operation unit;
RESET: You can press this button to restart the analyzing unit when it stops
responding.
WARNING:
Press the RESET button only when the analyzing unit stops
responding. Do not press this button when the unit is working normally.
Otherwise, it may lead to system failure, unreliable analysis results or
serious unexpected consequences.
Tube holder
Tube Rack
The sample disk is composed of two circles – an inner circle and an outer circle. It
provides 60 tube positions, 30 on the inner circle and 30 on the outer circle. Every
tube position has an identification number. Positions 1-45 are for samples, E1-E5 for
emergency samples, S1-S6 for calibrators, C1-C3 for controls, and W for distilled
water. All the other positions except the position W can be used for samples, too.
The sample disk can hold six types of tubes – micro sample cup, collection tube,
Φ12mm×68.5mm, Φ12mm ×99mm, Φ12.7mm×75mm and Φ12.7mm×100mm.
1-4
To install the sample disk, keep the handle at the vertical position, align the central
hole of the handwheel to the rotor, gently lower the sample disk all the way down
(rotate the disk a bit as necessary) and move the handle back to the horizontal
position to secure the disk to the rotor. When you have finished installing the disk,
grab the handwheel and lightly pull it upward. If the disk remains secured, it means it
is well installed.
To remove the sample disk, first shift the handle from the horizontal position to the
vertical position. Then grab the handle or handwheel and pull the disk upward to
remove it from the rotor.
To load sample tubes, insert the tube into the tube holder until the bottom of the tube
contacts the groove on the tube rack.
To remove sample tubes, grab the tube and pull it upward to remove it from the tube
holder.
WARNING:
Before installing/removing the sample disk, make sure the analyzing
unit is turned off and the sample disk has stopped.
Before installing/removing the sample tubes, make sure the analyzing
unit is turned off and the sample disk has stopped.
Do not use sample tubes other than the specified.
Before running the analyzing unit, make sure that the sample disk
cover is closed and the round red mark on the cover is aligned with its
counterpart on the panel. Otherwise the sample probe may be
damaged.
If samples spill in the sample compartment or on the sample disk, be
sure to wipe the spills with cloth soaked with water or disinfector after
turning off the analyzing unit.
The built-in sample bar code scanner (optional) can read the bar code labels on the
sample tubes.
The bar code labels can be applied to the following sample tubes.
Φ12mm ×99mm
Φ12.7mm×75mm
Φ12.7mm×100mm
1-5
The bar code labels applied to the sample tubes must meet the following
requirements.
The bottom of the sample tube fully contacts the tube rack of the sample disk.
There is no obstruction between the scanner and the bar code labels.
Stick the bar code label to the sample tube so that the lower end of the bar code
label is 8-10mm above the bottom of the tube.
The length of the bar code label is no more than 55mm with blank areas of 5 mm
are provided at both sides of barcode.
Tube
5mm
8-10mm
Inclination angle
Stick the entire surface of the label to the surface of the sample tube so it will not
peel.
When inserting the tube with bar code label into the sample disk, ensure the
center of the label is within the ±2mm range, as shown in the figures below.
1-6
+2mm
NOTE:
We recommend printing coding information beside barcode.
The bar code scanner can read the following bar code symbologies: Code 128 (Set A, B,
C), Code 39, Codabar, ITF (Interleaved 2 of 5), UPC/EAN, Code93
Feature size: 0.19-0.50mm
Length: 3-16
Thin bar: thick bar: 1:2.5-3
Height: 10mm or more
Printing: black print on white background; the minimum acceptable symbol grade
is Class C as defined in the ANSI MH10.8M Print Quality Specification.
NOTE:
To ensure the stability of reading Codabar, the length of it is no less
than 4.
The maximum number of digits will be determined after confirming that
the actual printed labels can be read properly.
1-7
Open the middle door of the analyzing unit and you will see the sample syringe (right)
and the reagent syringe (left). The sample syringe can aspirate/dispense 2-45μl of
sample for clinical chemistry tests and its minimum scale is 0.1μl.
Sample probe
wash well
Sample Syringe
To dispense the sample, the sample probe first moves to the sample tube to aspirate
certain amount of the sample, then to the reaction disk to dispense the aspirated
sample to a reaction cuvette and finally to the wash well for cleaning.
The sample probe can automatically detect the sample level. When the sample
probe contacts obstacles in the vertical direction, its safeguard will automatically
protect the probe from damage.
1-8
WARNING:
When the analyzing unit is running, do not place any part of your body
or any obstacle in the route the arm moves. Otherwise, it may lead to
personnel injury or equipment damage.
The reagent disk (as Figure 1-9 shows) holds the reagent bottles and rotates
(counter-clockwise only) the designated bottle to the position for the reagent probe to
aspirate.
The refrigerator keeps the reagents in a low temperature environment to keep them
stable and minimize volatilization.
Outer circle
Inner circle
Handle
Handle wheel
The reagent disk has two circles, inner circle and outer circle. There are 25 reagent
positions in each circle and the reagent disk has totally 50 reagent positions. The
reagent disk can hold the Inner-circle 50ml bottles, Outer-circle 50ml bottles, Hitachi
7060 bottles, Hitachi 7170 bottles, Hitachi 20ml bottles, Outer-circle 20ml bottles,
Inner-circle 40ml bottles, Outer-circle 40ml bottles and Outer-circle 62ml bottles.
The refrigerator can run 24 hours a day to keep the temperature at 2-10℃.
NOTE:
The refrigerator has a power supply independent of that of the
analyzing unit. It will be put into service once the POWER is turned on.
To install the reagent disk, keep the handle at the vertical position, align the central
hole of the handwheel to the rotor, gently lower the reagent disk all the way down
(rotate the disk a bit as necessary) and move the handle back to the horizontal
position to secure the disk to the rotor. When you have finished installing the disk, grab
the handwheel and lightly pull it upward. If the disk remains secured, it means it is
well installed.
1-9
To remove the reagent disk, first shift the handle from the horizontal position to the
vertical position. Then grab the handle or handwheel and pull the disk upward to
remove it from the rotor.
To load reagent bottles, insert the bottle into the bottle holder until the bottom of the
bottle contacts the groove on the bottle rack.
To remove the reagent bottle, grab the bottle and pull it upward to remove it from the
bottle holder.
WARNING:
Before installing/removing the reagent disk, make sure the analyzing
unit is turned off and the sample disk has stopped.
Before installing/removing the reagent bottles, make sure the
analyzing unit is turned off and the sample disk has stopped. When
installing the bottle, make sure the bottle bottom is in full contact with
the bottle rack.
Before running the analyzing unit, make sure that the reagent disk
cover is closed and the round red mark on the cover is aligned with its
counterpart on the panel. Otherwise the sample probe may be
damaged and cooling capacity of the refrigerator will be degraded.
If reagents spill in the reagent compartment or on the reagent disk, be
sure to wipe the spills with cloth soaked with water or disinfector after
turning off the analyzing unit.
Open the middle door of the analyzing unit and you will see the sample syringe (right)
and reagent syringe (left). The reagent syringe can aspirate/dispense 10-450μl of
reagent and its minimum scale is 1μl.
1-10
Reagent probe arm
Reagent
probe rotor
Reagent probe
Reagent syringe
To dispense the reagent, the reagent probe first moves to the reagent bottle to
aspirate certain amount of the reagent, then to the reaction disk to dispense the
aspirated reagent to a reaction cuvette and finally to the wash well for cleaning.
The reagent probe can automatically detect the reagent level. When the reagent
probe contacts obstacles in the vertical direction its safeguard will automatically
function to protect the probe from damage.
WARNING:
When the analyzing unit is running, do not place any part of your body
or any obstacle in the route the arm moves. Otherwise, it may lead to
personnel injury or equipment damage.
1-11
1.1.1.6 Mixer
The mixer is composed of a mixing bar, bar arm and rotor, as Figure 1-12 shows.
The mixing bar thoroughly stirs the reaction mixture (reagents and sample) in the
reaction cuvette.
Mixer arm
Mixer
Mixer rotor
For the single-reagent test, the mixer starts to work after the sample is dispensed
into the reaction cuvette. For the double-reagent test, the mixer starts to work after
the sample or the second reagent is dispensed into the reaction cuvette. The mixing
bar moves to a position above the reaction disk, lowers into the cuvette, and rotates
to mix the mixture in the cuvette. After that, the bar moves to the wash well for
cleaning and de-watering.
This loader loads new cuvettes to the reaction disk and dumps used cuvettes into a
bucket. The feeder is located in the cuvette compartment and transfers cuvettes to
the manipulator, which grabs the cuvettes and loads them to the reaction disk and
then unloads the used cuvettes and dumps them into the used-cuvette bucket. Open
the lower door of the analyzing unit and you will see the used-cuvette bucket in the
middle.
NOTE:
Normally, the used-cuvette bucket can hold 80 segments of reaction
cuvettes (10 cuvettes per segment). Be sure to empty the bucket in
time so that excessive cuvettes will not overflow and contaminate the
cabinet.
Disposable cuvettes are adopted as the reaction cuvettes. Ten cuvettes are bound
together as one cuvette segment. The cuvette compartment can house 30 cuvette
segments, which are sufficient for 300 continuous tests.
When all the cuvettes of a cuvette segment have been used, the reaction disk
rotates the segment to the unloading position, and then the manipulator dumps the
used segment into the used-cuvette bucket and loads the new segment. When a
1-12
segment is taken from the cuvette compartment, the cuvette feeder pushes the next
segment to the loading position.
When there are less than 10 segments in the compartment, the analyzing unit,
though keeping working, will give an alarm. Seeing the alarm, you should, if you still
have more tests to do, add more segments to the compartment.
When all the segments in the compartment are used, the analyzing unit will stop first
loading cuvette segments, and then stop dispensing samples when all the segments
on the reaction disk are used. But it will keep working until all the scheduled tests are
done.
Present the cuvette segment to the entry of the cuvette feeder as Figure 1-13 shows
and gently push it toward inside. Load all the segments one by one until they are all
loaded. When you are done, click the Load Cuvette button (refer to 4.1.4.2 Reaction
Disk tab for details) to command the cuvette feeder to press the newly added
segments forward. Be sure not to load the segments as Figure 1-14 shows.
NOTE:
When loading cuvette segments to the entry of the cuvette
compartment, be sure to keep them upright. Remove the inclined
segments immediately upon seeing them and reload them the right
way.
Be sure to load the segments to the cuvette compartment in the right
direction (Figure 1-13). Reversely loaded segments (Figure 1-14) may
jam the loader and halts the analyzing unit.
Do not click the Load Cuvette button before completing adding all the
cuvette segments to the compartment. Otherwise, the loading
operation may fail.
1-13
Figure 1-14 Loading cuvette segments the wrong way
BIOHAZARD:
Be sure to load the used-cuvette bucket to the designated position on
the bottom plate. Otherwise, the used-cuvette may not be dumped into
the bucket and the spilled reaction mixture may contaminate and
corrode the cabinet.
Be sure to wear gloves, goggles and protective clothing when loading
or removing the used-cuvette bucket.
Be sure to dispose of the used-cuvette in compliance with the local
regulations.
The reaction disk holds the reaction cuvettes, in which the sample reacts with the
reagents and colorimetric readings are taken.
The reaction disk can hold 8 cuvette segments (80 cuvettes). The cuvettes adopted
are
Disposable;
5mm×6mm×25mm (5mm optical path);
750μl (capable of holding 150-500μl of the reaction mixture).
1-14
The temperature chamber keeps the temperature at 37±0.3 ℃ with ±0.1 ℃
fluctuation.
BIOHAZARD:
Be sure to dispose of the used cuvettes in compliance with the local
regulations.
CAUTION:
The reaction cuvettes should not be re-used. Otherwise, the system
performance may be degraded.
During the analyzing process, the reaction disk rotates (counter-clock wise only) to
cuvette-loading position, sample-dispensing position, reagent-dispensing position, or
mixing position as needed. The colorimetric readings are taken when the specified
cuvette passes through the optical axis.
Specifications
9 optical paths with fixed interference filters.
Wavelengths: 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm,
700nm, 800nm (optional)
Half band-width: ≤12nm
Wavelength accuracy: ±2nm
Measurement range: 0.1-4.0 Abs
Lamp: tungsten-halogen
Movement
The measurement optical system consists of 9 optical paths. The absorbance is
taken when the reaction cuvette rotates to the correspond path. The analyzer can
measure the absorbance of 9 cuvettes simultaneously.
1-15
Figure 1-15 ISE unit (optional)
Pump module
ISE module
Reagent module to be
placed here
The ISE unit (optional) measures the concentration of Na+, K+ and Cl- in serum,
plasma and diluted urine.
The volume of the serum or plasma sample is 70µl and that of the diluted urine
sample is 140µl. The dilution ratio of the urine sample is 1:10 (1 part of urine sample
and 9 parts of urine diluent).
There are five electrodes including a spacer electrode Na+, K+, Cl- and reference
electrodes in the ISE module. Reagent module is integrated with Calibrant A,
Calibrant B, waste containers and a chip which indicates the volume of the reagents.
1-16
Shortcut buttons System status
Pull-down menu Menu area Header area Title bar area area
Display area
Header area
Displays the names of the operating software and the manufacturer.
Title bar
Displays the title of the current display area.
Menu area
Displays: [Routine], [Parameters], [Data], [System], [Help]. You can move the
mouse to any of the listed menu and click the left button of the mouse (hereinafter
referred to as click) to display its pull-down menu.
Pull-down menu
You can click the listed item of the pull-down menu to perform certain operation.
1-17
Small buttons
Click the small button to view the user guide. You can also click Help → Guide
to view the user guide. Refer to 4.5.2 Guide for details.
Click the small button to exit the operating software. You can also click Routine
→ Exit to exit the software. Refer to 4.1.8 Exit for details.
, , , , , , , , . You can
click any of the buttons to perform certain operation quickly.
Display area
Displays settings, results, graphics and so on.
Period area
Displays how many periods (every period lasts 12 seconds) of test have passed
since the beginning of the first test after the latest power-on.
Time area
Displays current date and time.
Operator area
Displays the current operator who operates the system.
Tab
See the figure below for examples of the tab. Click the tab and you can access the
screen that it indexes.
1-18
Combo box
Click “▼” and a pull-down list will display, as the figure below shows. Click the
desired item to select it.
Option button
Click the option button to select the option it represents. Note that for a given group
of option buttons, you can only select one of them.
Check box
Click the check box to select the option it represents and click it again to de-select it.
Note that for a given group of check boxes, you can choose more than one of them
at one time.
1-19
Edit box
You can enter characters from the keyboard in the edit box.
Button
Click a button and you can access the function it indexes.
Scroll bar
When the contents to be displayed are too many for one screen, you can use the
scroll bar to see the hidden contents. Move the cursor to the scroll bar, press left
button of the mouse and hold it, then you can drag the scroll bar upward or
downward to see the hidden contents. Or you can press the key such as Page Up,
Page Down,↑or↓on the keyboard to see the hidden contents.
Double-clicking
In this manual, “double-clicking” refers to moving the pointer of the mouse to the
desired item and click the left button of the mouse twice swiftly.
1-20
To select discontinuous targets:
Press and hold CTRL and click them one by one. Release CTRL when you have
selected all the targets.
1-21
1-22
2 Installation
WARNING:
The system should only be installed by our authorized personnel only.
To facilitate the installation, you should prepare a place meeting the requirements
specified in 2.2.5Space and Accessibility Requirements. If you need to move the
analyzer to another site, please contact our Customer Service Department or your
local distributor, who are the appropriate people for the moving job.
2.1 Unpacking
When you receive your analyzer, carefully inspect the package. If you see any signs
of mishandling or damage, file a claim immediately with our Customer Service
Department or your local distributor.
After opening the package, check the delivered goods against the packing list as
well as the appearance of the analyzer. If you find anything missing or damaged,
alert our Customer Service Department or your local distributor immediately.
CAUTION:
Make sure the analyzer is installed in a place meeting the following
requirements. Otherwise, it will not perform as promised.
CAUTION:
The analyzer radiates heat from its rear side when operating. A
well-ventilated environment helps keep the room temperature stable.
Use ventilation equipment if necessary. But if so, be sure not to
expose the analyzer to the direct draft that may lead to unreliable
results.
2-1
The site should be free of corrosive gas and flammable gas.
The bearing platform (or ground) should be free of vibration.
The site should not be disturbed by large noise or power supply.
The analyzer should not be placed near brush-type motors and electrical contacts
that are frequently turned on and off.
Do not use such devices as mobile phones or radio transmitters that generate
electromagnetic waves near the analyzer.
The above-sea-level height of the site should be lower than 2000 meters.
WARNING:
Make sure the power socket is grounded correctly. Improper grounding
may lead to electric shock and/or equipment damage.
Be sure to connect the analyzer to a power socket that meets the
above-mentioned requirements and has a proper fuse installed.
CAUTION:
When used in conditions other than the specified, the analyzer may
not provide reliable test results. If the temperature or relative humidity
does not meet the above-mentioned requirements, be sure to use
air-conditioning equipment.
2-2
BIOHAZARD:
Be sure to dispose of the waste according to the local regulations.
CAUTION:
The water to be used on the analyzer must meet the requirements of
the CAP Type II water. Insufficiently purified water may result in
misleading measurement.
WALL
Minimum500
Maximum2500
Operation
Unit
710
Analyzing Unit
980
F
Minimum500
R
O
N
T
Minimum500 Minimum500
Unit: mm
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below checks.
2-3
4 Connect the filter with the pickup tubes. Refer to 5.5.2 Replacing Filter
Assembly (step 2 - 3) for instructions.
Put the pickup tubes and the sensor into the deionized water tank, and
then turn the cap of the deionized water tank clockwise.
CAUTION:
Make sure that the filter sink smoothly to the tank bottom and
does not twist with the floater connecting rod.
5 Put the deionized water tank on the right of the extractable plate.
6 Push the extractable plate back in.
7 Plug the green connector to its counterpart on the analyzing unit and turn
the connector clockwise until secure.
Pickup Tube
8 Plug the red connector to its counterpart on the analyzing unit and turn the
connector clockwise until secure.
9 Plug the BNC connector to its counterpart on the analyzing unit and turn
the connector clockwise until secure.
10 Close the lower door.
NOTE
The tank should be cleaned every week. Use brush to clean the tank
walls if necessary. Check for contamination and impurity on the tank
walls and bottom, after cleaning.
If the tank will not be used for a long time, put it upside down to drain
the water and then store it in dry and clean environment. Clean it with
water before reusing.
2-4
5 Put the waste tank on the left of the extractable plate.
6 Push the extractable plate back in.
7 Keep pressing the pin on the connector and grab the waste tap and insert
it to the connector.
BNC Connector Waste Connector
Pin
Waste Tap
Waste Tube
8 Plug the BNC connector to its counterpart on the analyzing unit and turn
the connector clockwise until secure.
9 Close the lower door.
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below checks.
CAUTION:
Use the consumables recommended by our company. Other
consumables may degrade the system performance.
2-5
2.4.1 Installing Electrodes
NOTE:
The electrode storage for K is different from the other electrodes. For
there is some certain kind of solution in the lumen of the electrode, a
tape covering both ends of the lumen can be seen. So whenever
unpacking these electrodes, remove the tape first. If some of the
solution leaks outside of the electrode, it should be wiped before
installation.
Each electrode including the reference electrode has an O-ring on one
side of its lumen, so ensure the side with the O-ring towards up when
installing the electrodes. If the O-ring is missing, replace with a new
one. Extra two O-rings are supplied in the electrode boxes.
Connection Pins
O-ring
Red sphere
Insert
Place the reference electrode inside the housing by pressing down the
compression plate and push it straight against the back of the housing.
Release the compression plate and ensure the electrode cannot be easily
moved.
2-6
5 Remove the Chloride electrode from its protective packaging and place it
in the ISE module housing in the same way as the reference electrode.
6 Repeat the process for the Potassium electrode.
7 Repeat the process for the Sodium electrode.
8 Push all the electrodes simultaneously to ensure they are in correct
alignment.
All the electrodes for spacer electrode, Na, K and Cl are the same size
and shape. Connection pins at the rear of each electrode are different
which ensures that the electrodes are inserted in the correct order. So if
one of the electrodes can not be easily push into the housing, check the
electrode first then repeat the installation process.
9 Screw the screw of the ISE module cover.
10 Close the ISE unit door.
2-7
6 Enter the ISE screen and click the Replace button.
8 Enter “20” into the edit box to the right of Time(s) and click the Purge AB
button.
9 Close the ISE unit door.
2-8
3 Basic Operations
This chapter provides step-by-step procedures for operating the analyzer for basic
tasks.
3-1
3.2 Preparing for Analysis
BIOHAZARD:
Wear gloves, goggles and protective clothing when performing the
below checks.
Check the power supply and make sure it can supply proper voltage for the
analyzer.
Check the connections among the analyzing unit, operation unit and printer. Make
sure the connections are right and secure. Check the power cords of the
analyzing unit, operation unit and printer and make sure they are well connected
to power sockets.
Check and make sure sufficient printing paper is prepared for the printer.
Check the sample and reagent syringes for leakage as instructed by 5.2.1
Checking Sample/Reagent Syringes.
Check the sample and reagent probes and make sure there is no fluid hanging on
the probe tips. If there is, please contact our Customer Service Department or
your local distributor.
Check the connections of the deionized water and wastewater as instructed by
5.2.6 Checking Connection of Deionized Water and 5.2.7 Checking
Connection of Wastewater.
Check the sample probe and make sure it is neither dirty nor bent. If it is dirty,
wash it as instructed by 5.3.1 Washing Sample Probe; if it is bent, replace it as
instructed by 5.6.3 Replacing Sample Probe.
Check the reagent probe and make sure it is neither dirty nor bent. If it is dirty,
wash it as instructed by 5.3.2 Washing Reagent Probe; if it is bent, replace it as
instructed by 5.6.4 Replacing Reagent Probe.
Check the mixing bar and make sure it is neither dirty nor bent. If it is dirty, wash it
as instructed by 5.3.3 Washing Mixing Bar; if it is bent, replace it as instructed
by 5.6.5 Replacing Mixing Bar.
Check the cuvette compartment and make sure there are sufficient cuvettes in it.
If the cuvettes are not sufficient, add more cuvettes as instructed by 1.1.1.7
Reaction Cuvette Loader.
CAUTION:
You must prepare enough cuvettes for the upcoming analysis. If you
find the cuvettes are not enough, add more immediately.
Sometimes the new cuvettes are not as smooth as they should be.
Check the surface of the cuvettes for bumps and take necessary
measures to remove the found bumps before loading them to the
compartment. Otherwise, they may jam the analyzing unit.
Check and make sure there is enough deionized water in the deionized water
tank as instructed by 5.2.8 Checking Remaining Deionized Water.
3-2
CAUTION:
You must prepare enough deionized water. If you find the deionized
water is not enough, add more deionized water to the tank.
Check the waste tank and make sure it is empty. If not, empty the tank as
instructed by 5.2.9 Emptying Waste Tank.
Check the used-cuvettes bucket and make sure it is empty. If not, empty the
bucket as instructed by 5.2.10 Emptying Used-Cuvettes Bucket.
3.2.2 Power-on
Power up the analyzer in the sequence presented below:
NOTE:
Ensure the hibernation function of the display is unavailable:
After entering the display properties screen, select Never for Turn off
monitor, Turn off hard disks and System standby on the Power
Schemes tab and do not select Enable hibernation on the Hibernate
tab.
After you have logged on the WINDOWS operating system, you may
The operating software will do the initialization procedure in the sequence presented
below:
The system does the startup and warm-up procedures in the sequence presented
below and the analyzer will then enter the standby state:
3-3
Initializing database, system environment and printer; connecting to the LIS
(Laboratory Information System. If the LIS server is configured.); downloading
settings; shaking hands with the modules; running self-tests and resetting the
modules. A dialog box will then pop up to ask you to enter your username and
password.
NOTE:
You need to enter proper username and password to access the
control system. Use the initial username and password (username:
administrator; password: bs300) if this is the first time the control
system being used and then you may edit your own username and
password as instructed by 4.4.4 User.
CAUTION:
You may start the analysis once the initialization is finished. However,
we recommend you wait until the temperature and photometric system
is fully stabilized, which is when the status box displays Idle and the
analyzer has been turned on for 30 minutes.
If this is the first time the analyzer is installed, please follow the
instructions indicated in 5.5.2 Replacing Filter Assembly (step 4) to
expel air from the filter assembly.
You must complete all the following settings if this is the first time the analyzer being
used.
Before requesting the tests, you must finish the following settings:
To set the options regarding the basic parameters of the system, refer to 4.4.2
Setup.
To set the options regarding the hospital information, refer to 4.4.3 Hospital.
To set the options regarding test parameters and reference, refer to 4.2.1.1
Parameters tab and 4.2.1.2 Reference Range tab.
To set the options regarding calibrators and calibration, refer to 4.2.3.1 Calibrator
tab and 4.2.3.2 Rule tab.
3-4
To set the options regarding controls, QC rule and QC test, refer to 4.2.4.1
Control tab, 4.2.4.2 Rule tab and 4.2.4.3 Setup tab.
To set the options regarding the reagent parameters, refer to 4.2.2.1 Reagent
Disk tab.
To set the options regarding the carryover information among tests, refer to
4.2.1.5 Carryover tab.
To set the options regarding the printing parameters, refer to 4.4.7 Print.
3.3.1 Calibration
You must calibrate if this is the first time the analyzer being used.
CAUTION:
You need to run the calibration again when you change reagent lots,
test parameters, lamp or other conditions.
To view the results at the Status→Calib. Test, refer to 4.1.4.4 Calib. Test tab.
To view the results at the Status→Sample Disk, refer to 4.1.4.1 Sample Disk
tab.
To view the results at the Calibration→Result, refer to 4.2.3.3 Result tab.
3-5
If the ISE unit is connected, refer to 4.4.11.1 Calibration for detailed information
about running ISE calibration and check its results.
3.3.2 QC
To request QCs, refer to 4.1.3 QC.
After requesting QCs, you should load corresponding controls to their assigned
positions on the sample disk.
To view the results at the Status→QC Test, refer to 4.1.4.5 QC Test tab.
To view the results at the Status→Sample Disk, refer to 4.1.4.1 Sample Disk
tab.
To view the results at the QC → Real-time Result /Daily Result /Day-to-day
Result, refer to 4.2.4.4 Real-time Result tab, 4.2.4.5 Daily Result tab or 4.2.4.6
Day-to-day Result tab.
3.3.3 Samples
To request samples, refer to 4.1.1 Samples.
You can request a STAT sample run in the way similar to an ordinary run, except that
you have to tick the check box to the right of STAT, as Figure3-1 shows. The
requested STAT run will be inserted into the current work list as Waiting and has
higher priority than other tests.
After requesting, load the samples to their corresponding positions on the sample
disk.
To view the results at the Status→Sample Test, refer to 4.1.4.3 Sample Test
tab.
To view the results at the Status→Sample Disk, refer to 4.1.4.1 Sample Disk
tab.
To view the results at the Data→Result→Results, refer to 4.3.4.1 Results tab.
3-6
CAUTION:
Sample run results can only be edited by authorized personnel.
To edit one or more sample run results, refer to 4.1.4.3 Sample Test tab or 4.3.4.1
Results tab for details.
To revise one or more sample run results, refer to 4.1.4.3 Sample Test tab or 4.3.4.1
Results tab for details.
3.4.2 Shutdown
After exiting the Windows operating system, switch off the following powers in the
presented order:
NOTE:
The refrigerator still functions after the ANALYZING UNIT POWER is
placed to OFF. To shut down the refrigerator, place the POWER to
OFF.
3-7
BIOHAZARD:
Exercise with caution. Wear gloves, goggles and protective clothing.
3-8
4 Advanced Operations
The chapter presents an introduction of the operating software by menus.
The main interface of the operating software has five major menu groups:
Routine
Parameters
Data
System
Help
4.1 Routine
4.1.1 Samples
Click Routine → Sample, or press F1 to enter the Request Sample screen, as
Figure4-1 shows. You can also enter the Request Sample screen by clicking the
short-cut button .
4-1
Figure4-1 Request Sample screen
The Assays zone lists all available tests. You cannot request the assays followed by
Finished: all finished samples that are either released or not released on the
day.
If duplicate samples are downloaded, you can choose any option from Neglect,
Overwrite or Add to deal with the samples.
4-2
Parameter What it does How to set
Sample No. Defines the identification number Use the system-generated
of the sample or samples. You can ID(s) or enter the desired
enter the desired integers (1-9000) ID(s) manually.
into the edit boxes respectively as
the start (left) and end (right) IDs.
If you are entering only one
sample’s ID ensure the two IDs are
the same.
Index A system-generated number for
fast search.
Sample ID Enter it manually, or leave it
blank.
Position Defines the sample’s position on Use the system-generated
the selected sample disk. For number, click “ ▼ ” to the
STAT samples, we recommend right of Position to select
they be placed on positions E1-E5. the desired position.
For multiple samples, the
selected position represents
that of the first sample and
the analyzer will generate
positions for the rest of the
samples.
Tube Defines which type of tube holds Click “ ▼ ” to the right of
the sample. Tube and select either
Large tube or Small tube
from the pull down list.
Type Defines the sample type. Click “ ▼ ” to the right of
Type and select one of the
following four types: Serum,
Plasma, Urine and Others.
Replicates Defines for how many times the Enter the desired integer
analyzer should run this sample.
(1-10) or click the button
The default value is 1.
to the right of Replicates
until the desired integer is
reached.
STAT Defines whether the sample is a Tick the check box to the
stat sample. The analyzer will add right of STAT.
the stat sample to the current work
list.
S. Blank Applies to the tests that use Tick the check box to the
Endpoint method. right of S. Blank to enable
this function and click it
Defines whether to replace the
again to disable it.
reagents with distilled water and
take the absorbance of the mixture
before formally analyzing the
reagents-sample mixture.
This parameter is only available for
clinical chemistry tests.
4-3
Parameter What it does How to set
Dilution Defines whether to dilute the Tick the check box to the
sample before analyzing it. right of Dilution to enable
this function and click it
This parameter is only available for
again to disable it.
clinical chemistry tests.
NOTE:
If the built-in bar code scanner (optional) is not connected, the function
is unavailable.
4-4
4 If you want to download information of the scanned samples from the LIS
server, click the Download button.
NOTE:
The Download button is only available if you select
Real-time Download at the System SetupÆHost
Communication screen.
NOTE:
If there is no LIS server connected, the function is unavailable.
1 Click the Download All button and a dialog box pops up.
4-5
2 Click the Start button and the system will download all the sample
information from the LIS server.
If you want to cancel the downloading, click the Cancel button.
If there are samples that have been requested but not able to test, a
dialog box which is shown as the figure below will pop up to remind you.
You can click the Close button to exit the dialog box. Refer to the
following content To view requested but untestable samples for details.
NOTE:
If there is no LIS server connected, the function is unavailable.
1 Enter the bar code into the edit box to the right of Sample ID for the
current sample, or click the Browse button and find the sample whose
sample information you want to get from the LIS server.
4-6
2 Click the Download Single button to get sample information
corresponding to the bar code from the LIS server.
NOTE:
The system will download information only for the sample
that meets any of the following conditions:
(1) It has not been requested before;
(2) All the tests requested for it before are at Requested
status and Overwrite has been selected at the Host
Communication screen (refer to 4.4.2.4 Host
Communication tab).
To request samples
1 Set the parameters as instructed above.
2 Click the desired test to select it; click it again to de-select it. The selected
test will be followed by a green tick. You may select multiple tests for a
sample run.
You may also request a pre-defined profile or profiles and the selected
profile or profiles will also be followed by a green tick.
4-7
NOTE:
Routine sample can be requested on any virtual sample disk.
STAT sample can only be requested on the default virtual sample disk.
After the system is powered on, the sample disk 1 is the default at that
time.
If there are any sample runs in Waiting or Running status on a sample
disk, the disk is the default at that time.
If the system just finishes the runs on a sample disk, the disk is the
default at that time.
If you request a sample whose sequence number has been used on
the current day (the same No., but the different index) and you’ve set
the Sample ID and Type (sample type) for it, the system will consider
the Sample ID and Type of the former one as those of the current
sample. You can change the two parameters only at the
Demographics screen.
4-8
3 If you want to run the untestable test, you have to find the cause why it is
untestable and take some actions. For example, if the test ALB has not
been calibrated, it will become testable after being calibrated.
4 If you want to add the sample to the requested test list, tick the combo
box to the left of the sample and click the Test button. If you want to
select all the samples, tick the combo box to the left of Select All.
You can see the selected sample at the Test Status screen.
If there are untestable tests for the selected sample, the tests will be
discarded and you will not see them at the Sample Test screen.
5 Click the Close button.
NOTE:
Click to go to the previous sample run.
Click to go to the next sample run.
3 After you have finished browsing samples, click the Browse button again
to quit the browsing mode.
NOTE:
Click to go to the previous sample run.
Click to go to the next sample run.
NOTE:
You can edit routine sample information here only if the
sample is in Requested status.
You cannot edit STAT sample information here because the
STAT sample is in Waiting status after it is requested.
Sample Disk, Sample No. and Replicates can’t be edited.
You can edit Sample Type and Sample ID only at the
Demographics screen. Refer to 4.3.3 Demographics for
details.
4-9
5 If you do not want to change the assays for the sample, go directly to the
next step.
Otherwise, select tests and profiles in the Assays area or Profiles area.
If you want to add an assay or a profile, select it; if you want to delete an
assay or a profile, de-select it.
NOTE:
You can change the tests or profiles for the sample in any
status.
You can only delete a test or a profile for the sample in
Requested status.
6 Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
7 Repeat from step 2 to edit another sample run; or click the Browse button
again to quit the browsing mode.
NOTE:
Click to go to the previous sample run.
Click to go to the next sample run.
NOTE:
You can only delete the routine sample that is in Requested
status here.
You cannot delete the STAT sample here because the STAT
sample is in Waiting status after it is requested. If you want
to delete a requested STAT sample, refer to 4.1.4.1 Sample
Disk tab or 4.1.4.3 Sample Test tab for details.
4 Repeat from step 2 to delete another sample run; or click the Browse
button again to quit the browsing mode.
4-10
4.1.2 Calibration
At the Request Calibration screen, all the available tests are listed. The tests
followed by forbidden marks, such as , are those whose calibration
parameters have not been set yet or have been set up incorrectly. The yellow-framed
tests are the double-reagent tests whose reagent positions have already been set.
The gray-famed tests are the double-reagent tests whose reagent positions have not
been set yet. The selected test will be followed by a green tick.
You can select the desired sample disk (virtual disk) from the pull down list of the
Sample Disk filed. The default sample disk is Sample Disk1. The adopted
calibration rule and calibrator will be displayed in the Method and Calibrator fields
respectively.
4-11
2 Click the desired test to select it; click it again to de-select it. The select
test will be followed by a green tick. You can select multiple tests for a
calibration run.
CAUTION:
You must run the calibration if this is the first time the analyzer using
Endpoint or Fixed-time method for double-reagent tests. For the
Kinetic method, you can directly input the K Factor without running the
calibration first (see 4.2.3.2 Rule tab).
You need to run the calibration when you have changed the reagents,
reagent lots, test parameters, lamp or other analysis conditions.
Every time before recalibration, do not program samples unless
calibration has been finished.
Before calibrating a double-reagent test that uses Endpoint method,
the system will run reagent blank test for it automatically.
4.1.3 QC
Click Routine → QC, or press the F3 to enter the Request QC screen, as Figure4-3
shows. You can also enter the Request QC screen by clicking the shortcut button
4-12
Figure4-3 Request QC screen
The screen lists all available tests. The tests whose reagent positions have not been
set yet are followed by a forbidden symbol, such as , and you cannot
request to run them. The double-reagent tests, whose reagent positions have
already been set, are yellow-framed; the double-reagent tests, whose reagent
positions have not been set yet, are gray-framed. The selected test is followed by a
green tick.
When any test is selected, its corresponding control information will be displayed in
the Controls filed. The default sample disk (virtual disk) is disk 1 and you should
select the appropriate sample disk to the actual arrangement.
NOTE:
If the auto QC function is enabled (see 4.4.2.1 Routine tab for details)
and the QC interval is not 0 (see 4.2.4.3 Setup tab for details), the
analyzer will automatically insert QC runs among sample runs and you
do not have to request additional QC runs.
To request a QC run
1 Click “▼” below Sample Disk and select the desired sample disk from the
pull down list.
4-13
2 Click the desired test to select it; click it again to de-select it. The selected
test will be followed by a green tick. You may select multiple tests for one
run.
.
3 Click the Request button to request a QC run.
4 Repeat steps 1 - 3 to request another QC run, or click the Close button to
exit the Request QC screen.
4.1.4 Status
Click Routine → Status or press F4 to enter the Status screen, as Figure 4-4
shows. You can also enter the Status screen directly by clicking the
button.
Sample Disk
Reaction Disk
4-14
Sample Test
Calib. Test
QC Test
As Figure 4-5 shows the Sample Disk tab consists of three major parts, a sample
disk diagram on the left, sample information and tests on the right and operating
buttons on the bottom.
The sample disk diagram illustrates two circles. Every position consists of two
color-coded rings, the inner ring and the outer ring:
4-15
To delete a sample in Requested or Waiting status
1 Select the desired sample disk from the pull down list in the Sample Disk
field.
2 Click the desired position on the selected disk. Note that you can only
select a sample which test(s) is (are) all in Requested or Waiting status.
3 Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
4 Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel deletion.
To rerun a sample
1 Select the desired sample disk from the pull down list in the Sample Disk
field.
2 Click the desired position on the selected disk. Note that you can only
rerun a routine or STAT sample.
3 Select the test or tests need to be included in the rerun. Click the check
box to select it. Click the check box again to de-select it.
4-16
4 To rerun the selected sample without dilution, go directly to the next step.
To dilute the selected sample before the rerun, tick the Diluted field. Only
if the dilution parameters of a test have already been set, the sample will
be diluted before the rerun.
4 Click the Reaction Curve to check the reaction curve and data of the
selected blank runs.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
5 If you have no intention to view other results, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
window; or click the Close button and repeat from step 2.
6 Click the Close button to close the Reaction Curve window.
4-17
Figure 4-6 Reaction Disk tab
As Figure 4-6 shows, the Reaction Disk tab consists of three major parts, a reaction
disk diagram on the left, test information, status and results on the right and
operating buttons on the bottom.
The reaction disk illustrates 80 reaction cuvette positions, all of which are
color-coded.
4-18
NOTE:
The Push Cuvettes button is only to command the cuvette feeder to
press the cuvette segments forward.
As Figure 4-7 shows, the Sample Test tab consists of the following tabs:
Unfinished Samples
Results by Samples
Results by Tests
Unfinished Samples
The Unfinished Samples tab lists all the Requested, Waiting and Running samples
of the current day since the latest power-on.
4-19
Figure 4-8 Unfinished Samples tab
NOTE:
In the Delete Sample dialog box, you can click the Refresh button to
view current samples in Requested or Waiting status.
4-20
To view reaction curve of a finished test
1 Select a virtual sample disk in the Sample Disk field.
2 Select a sample in the Samples field.
3 Select a test in the Finished status in the Assays field.
4 Click the Reaction Curve button to pop up the Reaction Curve screen
that shows the reaction curve of the selected test.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
5 If you have no intention to view other results, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
screen; or click the Close button and repeat from step 2.
6 Click the Close button to close the Reaction Curve window.
4-21
2 Enter the number of the start sample into the first dialog box that pops up
and then click the OK button. A second dialog box will then pop up.
3 Enter the number of the end sample into the second dialog box that pops
up and click the OK button to select the two samples and those between
them.
2 Enter the number of the start sample into the dialog box that pops up and
then click the OK button. Another dialog box will then pop up.
3 Enter the number of the end sample into the second dialog box that pops
up and click the OK button to de-select the two samples and those
between them.
4-22
To print out a patient report
1 Select a virtual sample disk in the Sample Disk field.
2 Select the desired sample or samples in the Samples field. You can use
the Select button or select them one by one.
3 Click the Print Pat. Report button and a print preview window will pop up.
At the Print Preview window, you may choose Pr. Series (series printing)
for your impact printer; you may choose Pr. Current (printing current
page) or Pr. All (printing all pages) for other types of printers.
NOTE:
You can click (to the first page), (to the
previous page), (to the next page) or (to the
last page) to go to the desired page.
Pr. Current refers to printing the page currently displayed on
the screen.
Pr. All refers to printing all the pages of the selected sample
runs.
4 When the printing is done, click the Close button to exit the Print Preview
window.
NOTE:
Sample results can only be edited by authorized personnel.
6 If you want to save the new results, click the Save button; otherwise, click
the Cancel button.
4-23
NOTE:
You can only edit sample results of the current day since the latest
power-on here.
1 Click the Print Daily Summary button and a dialog box will pop up to ask
you to confirm the printing.
2 Click the OK button to confirm the printing; click the Cancel button, for any
reason, to abort the printing.
Once you click the OK button, another dialog box will pop up to ask you to
select a printer.
4 Enter the date (the default is the current date) and click the OK button to
print out the patient results; click the Cancel button, for any reason, to abort
the printing.
If there is no result of the entered date, a dialog box will pop up to alert you.
Click the OK button to close the dialog box and abort the printing.
Results by Tests
The Results by Tests tab lists all the finished sample tests of the current day since
the latest power-on. You can print the test report and revise results through this tab.
4-24
Figure 4-10 Results by Tests tab
2 Enter the number of the start test into the first dialog box that pops up and
then click the OK button. A second dialog box will then pop up.
3 Enter the number of the end test into the second dialog box that pops up
and click the OK button to select the two tests and those between them.
4-25
2 Enter the number of the start test into the dialog box that pops up and
then click the OK button. Another dialog box will then pop up.
3 Enter the number of the end test into the second dialog box that pops up
and click the OK button to de-select the two tests and those between
them.
3 Click Reaction Curve to check the reaction curve and data of the
selected test.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
4 If you have no intention to view other results on the current virtual sample
disk, go directly to the next step;
Otherwise, click the Previous or Next button at the Reaction Curve
screen; or click the Close button and repeat from step 2.
5 Click the Close button to close the Reaction Curve screen.
4-26
To revise sample results
NOTE:
Sample results can only be revised by authorized personnel.
If you are not authorized to revise the results, a dialog box will pop up
to ask you to enter the authorized user name and password.
5 If you want to revise the tests with the formula Y=aX+b (Y stands for the
new result and X stands for the old result), click the Save button;
otherwise, click the Cancel button.
After clicking the Save button, you can see the test result in the Finished
Tests field have been changed to the new ones.
NOTE:
You can only revise the sample results of the current day since the
latest power-on here.
4-27
Figure 4-11 Calib. Test tab
4-28
2 Select a calibrator from the Calibration Status zone.
3 Click the Reaction Curve and a window will pop up to display the
corresponding reaction curve.
There are two tabs in the Reaction Curve screen: the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
4 Go directly to the next step if you have no intention to check other results;
Otherwise, click the Previous or Next button to view other results (not
only the results of calibrations) or click the Close button and then repeat
from step 1.
5 Click the Close button to close the Reaction Curve window.
4-29
To view calibration curve
1 Select a Finished calibration test in the Assays field.
2 Click the Calib. Curve button to display the calibration curve and the
calibration result.
To print the displayed curve and result, click the Print button.
3 Click the Return button to exit the Calibration Curve window.
4-30
To view status of QC run
1 Select a QC run in the Assays field. You can view the parameters and the
status of the selected run and the results of the Finished runs.
4-31
3 Click the Reaction Curve and a window will pop up to display the
corresponding reaction curve.
There are two tabs in the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
4 Go directly to the next step if you have no intention to check other results;
Otherwise, click the Previous or Next button to view other results (not
only the results of QCs) or click the Close button and then repeat from
step 1.
5 Click the Close button to close the Reactive Curve window.
4-32
To exit the Status screen
1 Click the Close button to exit the Status screen.
4.1.5 Start
Start is used to run the requested tests.
If the current tests are paused, Start will change to Resume that is used to continue
the paused tests.
Start tests
1
Click Routine → Start or press F5, or click the short-cut button to
pop up the following dialog box.
2 In the Select Samples dialog box, select a virtual sample disk to the right
of Sample Disk.
NOTE:
If there are any requested STAT samples on the current
default virtual sample disk, you can only select the disk.
4-33
3 In the Select Samples dialog box, select samples to be run in the Select
sample to be run field.
If you select All Samples, go directly to the step 5; if you select Selected
Samples, go to the next step.
NOTE:
If you select All Samples, the system will run all the
Requested samples (Waiting STAT samples included),
calibrations and QC tests.
If you select Selected Samples, the system will run some
Requested samples, calibrations and QC tests. When
Selected Samples is selected, the Select Samples field is
available.
4 In the Select Samples dialog box, select tests to be run in the Select
Samples field.
If you want to run sample tests, select the check box to the left of Sample
No. and enter the sample No. in the edit boxes to the right of it. The
system will run the Requested samples whose IDs are between the two
numbers (including the two numbers).
If you want to run calibration tests, select the check box to the left of
Calibration and select tests below it.
If you want to run QC tests, select the check box to left of QC and select
tests below it.
4-34
5 If you want to continue, click the OK button; otherwise, click the Cancel
button.
When you click the OK button, a dialog box will pop up.
6 Select a virtual reagent disk in the Select Reagent Disk dialog box.
7 If you want to run the selected tests, click the OK button; otherwise, click
the Cancel button and the system will not run the selected tests.
When you click the OK button, the status of the selected tests changes to
Waiting and the system will run the tests that use the reagents on the
selected virtual disk immediately.
NOTE:
If the system finishes the tests that use the reagents on the selected
virtual reagent disk, and there are waiting tests that use reagents on
the other disk, a dialog box will pop up to remind you.
Click the OK button to exit the dialog box.
After replacing the reagent disk, click the Resume button to continue
the tests that use reagents on the other disk. Refer to the following
contents for details.
Resume tests
1 When the system is paused, click Routine → Resume or press F5, or
click the short-cut button to continue the tests. The system will
take different operations according to different conditions. Refer to the
following steps for details.
2 If there is no test in Requested status and no need to replace the reagent
disk, the system will continue the tests directly.
3 If there is no test in Requested status but you need to replace the reagent
disk, the following dialog box will pop up.
4-35
4 If there are tests in Requested status, the following dialog box will pop up.
If you want to continue the tests currently being paused, click Cancel
button;
If you want not only to continue the tests currently being paused but also
to run the tests in Requested status, select tests and click the OK button.
After that, if there is no need to replace the reagent disk, the system will
continue the tests; if you want to replace the reagent disk, a dialog box
will pop up.
Click Routine → Probe Stop, or press F6, or click the short-cut button to
stop the sample and reagent probes and the mixing bar without stopping the reaction
disk. You may use this function to add more samples or reagents without stopping
the analysis. This menu is only functional when the system is testing.
NOTE:
Do not put the probes and the bar on hold for too long. Otherwise,
certain analyses may be affected.
4-36
4.1.7 Stop
Click Routine → Stop, or press F8, or click the short-cut button to stop the
current run. This menu is only functional when the system is testing.
NOTE:
We recommend this stop function not be used unless it is necessary
(for instance the analyzer is experiencing problems). When the
analyzer is experiencing a serious problem, the analyzer will be
stopped automatically.
After the analyzer is stopped, all the remaining runs will be invalidated
and return to the Requested status, but the finished runs will be
4.1.8 Exit
When you have finished all analyses and the system is in the idle status, click
Routine → Exit, or press F10, to exit the control system. A dialog box will pop up to
ask you to confirm the exiting operation.
Click the OK button and another dialog box will pop up to ask you to load detergents.
NOTE:
Please use our recommended detergents: 0.1mol/l hydrochloric acid,
or CD80 wash solution.
Use of other detergents may lead to inaccurate results. Do not use
other detergents.
Ensure acid and alkaline detergents are loaded to positions 45 and 47 respectively
and then click the OK button and the analyzer will start the following shutdown
procedure:
4-37
2 Carry out the washing procedure: washing the sample probe, reagent probe
and mixing bar for three times respectively with the acid and alkaline
detergents.
3 Wash the analyzing unit with deionized water as defined by Times of Auto
Washing(Startup/Shutdown) at the System SetupÆRoutine screen.
4 Unloads the first cuvette segment.
When the shutdown procedure is done, a dialog box will pop up to remind you that
you can shutdown the ANALYZING UNIT POWER to OFF safely. Click the OK
button to exit the control software.
NOTE:
Use this emergency exit function only when the analyzer is
experiencing a serious problem.
4.2 Parameters
4.2.1 Assay
The Assay Parameters screen is where you set parameters regarding the tests,
calculation tests, profiles, carryover and off-system tests.
To enter the Assay Parameters screen, click Parameters →Assay, or press the
F11 key on the keyboard.
NOTE:
If you are not authorized to edit the test parameters, a dialog box will
pop up to ask you to enter the authorized user name and password.
4-38
Figure 4-13 Assay Parameters screen
At the Assay Parameters screen, shown in Figure 4-13, you can see the following
tabs:
Parameters
Reference Range
Calculation
Profile
Carryover
Off-system
4-39
The Parameters tab consists of three main parts, the upper part being the
parameters to be set for the selected test, the middle part being all the tests whose
parameters are set already, the lower part being the operating buttons.
In the middle part, yellow-framed tests are the double-reagent tests whose reagent
positions are set already; the gray-framed tests are the double-reagent tests whose
reagent positions are not set yet; the non-framed tests are the single-reagent tests.
Follow the instructions given below to set the parameters for the selected test.
4-40
Parameter What it does How to set
R2 Vol. Defines the volume Enter the desired integer (10-450)
(10-450 μl) of the into the edit box to the right of R2
second reagent to be Vol..
dispensed for the
Note the entered Sample Vol. + R1
reaction.
Vol. + R2 Vol. must be 162μl -500μl.
Lin. Limit Applies to the Kinetic Enter the desired value (1-100) into
type only. It ranges from the edit box.
1 to 100 and the default
value is 20.
The analyzer will
automatically calculate
the linearity within the
measurement time and
compare the result to
the line limit and flag the
result exceeding the
defined limit.
The formula to calculate
the linearity is as
follows:
(1)When more than 9
points are measured
Linearity = (absorbance
change of the first 6
points – absorbance
change of the last 6
points)/(absorbance
change of all the points)
× 100
(2)When the 4 ≤number
of measured points ≤8
Linearity = (absorbance
change of the first 3
points – absorbance
change of the last 3
points)/(absorbance
change of all the points)
× 100
Inc. Time Applies only to Enter the desired integer (1-60) into
double-reagent tests. the edit box to the right of Inc. Time.
Defines the interval
(counted in periods.
One period equals 12
seconds) between the
point the sample is
dispensed and the point
the second reagent is
dispensed.
4-41
Parameter What it does How to set
R. Time Defines the reaction Find the corresponding integers
time (counted in listed on the instructions of the
periods. One period reagent and enter them into the edit
equals 12 seconds). For boxes to the right of R. Time.
the Endpoint method,
Enter the start time into the first box.
the reaction time refers
For the single-reagent test to be
to the interval between
analyzed by the Endpoint method,
the start of the reaction
the start time is 0; For the
and the end of the
double-reagent test to be analyzed
reaction; for the Kinetic
by the Endpoint method, the start
or Fixed time method,
time can be negative (-incubation
the reaction time refers
time-100); For any test to be
to the interval between
analyzed by the Kinetic or Fixed time
the point when the
method, the start time must be
reaction becomes
positive.
stabilized and the point
when the reaction is no Enter the end time, which is no less
longer monitored. than 0 and no greater 100, into the
second box. The end time must be
The entered integers
greater than the start time. For any
must be no less than
test to be analyzed by the Kinetic
-40 and no greater than
method, the end time must be
100.
greater than the start time 7 at least.
The analyzer defines
the start time of the
reaction as 0. For the
single-reagent test the
start time refers to the
point when the sample
is dispensed; For the
double-reagent test, the
start time refers to the
point when the second
reagent is dispensed.
Antigen Defines whether the Click the check box to the right of
analyzer should check Antigen to enable the check; Click it
for surplus antigen. again to disable the check.
When the antibody
reacts with the antigen,
the amount of the
product is closely
related to their
proportion. Only the
appropriate proportion
can introduce the
maximum amount of the
product and when this
happens, the
transmitted light is
minimized and the
largest absorbance is
obtained. Any other
proportion will lead to a
less absorbance and
when this happens,
samples of significantly
different antigen
concentrations may
4-42
Parameter What it does How to set
have the same test
results.
The surplus antigen
threshold (Antigen)
refers to the maximum
or minimum PC when
there is no surplus
antigen.
4-43
Parameter What it does How to set
reaction, if :
the calculated threshold
of the sample (including
controls) is greater than
that of the
maximum-concentration
calibrator, and
the absorbance of the
last point of the sample
(including controls) is
less than that of the
maximum-concentration
calibrator
then there is surplus
antigen.
Substrate Defines whether the Enter the desired number (0-4).
analyzer should check When the entered number is 0, the
for surplus substrate analyzer does not check for surplus
and applies only to the substrate.
Kinetic and Fixed time
method.
Substrate limit refers to
the maximum
absorbance
corresponding to the
starting point of the
reaction, i.e. the first
measuring point when
last reaction analyte is
dispensed and then
mixed.
Response Defines allowed Find the corresponding values on
maximum (for the instructions of the reagent and
ascending reaction) or enter them respectively to the edit
minimum (for boxes to the right of L Limit and U
descending reaction) Limit in the Response field.
absorbance (for the
Enter 0s into both the edit boxes if
Endpoint method) or
there is no restriction on the
absorbance change rate
response.
(for other methods).
S. Volume Defines the volume of Enter the desired integer (2-45).
the sample to be
S. Volume and Ratio must meet the
diluted.
following requirement:
120 ≤ (SampleVol. × (Dilution + 1)) ≤ 500
Ratio Defines the dilution Enter the desired integer (2-150).
ratio.
S. Volume and Ratio must meet the
following requirement:
120 ≤ (SampleVol. × (Dilution + 1)) ≤ 500
4-44
Parameter What it does How to set
R1 Blank Defines the allowed Find the corresponding values on
absorbance range of the instructions of the reagent and
the R1 blank (R1 refers enter them into the edit boxes to the
to the reagent of a right of L Limit and U Limit in the
single-reagent test or R1 Blank field.
the first reagent of the
Entering 0s into both the edit boxes
double-reagent test).
means there is no need to check the
The analyzer will flag
R1 blank.
the blank result that is
beyond the defined
range.
Mix. R. Blank Defines the allowed Find corresponding values on the
absorbance range of instruction of the reagent and enter
the mixture (reagents + them into the edit boxes to the right
sample) of the of L Limit and U Limit in the Mix. R.
double-reagent test. Blank field.
The analyzer will flag
Entering 0s into both the edit boxes
the blank result that is
means there is no need to check the
beyond the defined
reagent blank of the mixture.
range.
Linearity Defines the range in Find the corresponding values on
which the reaction result the instructions of the reagent and
is linear with the enter them into the edit boxes to the
response (R). The right of L Limit and U Limit in the
analyzer will flag the Linearity field.
blank result that is
Entering 0s into both the edit boxes
beyond the defined
means there is no need to check the
range.
linearity.
Slope/Intercept These two fields are for Enter the slope and intercept in the
compensation of test two edit boxes.
results.
When test result of a
test is found to be
shifted a little during
quality control, it can be
compensated with the
following equation:
Y=a*X+b
Where,
X - Test result
Y - Compensated result
a - Slope
b - Intercept
Full Name Defines the full name of Enter maximum 60 letters, digits
the current test. and/or symbols into the edit box to
the right of Full Name.
Print No. Defines a printing Enter the desired integer into the
number for the current edit box to the right of Print No.
test.
4-45
NOTE:
Please define the parameters as instructed by this operation manual
and the instructions of the reagent suppliers. Improper settings may
lead to unreliable test results.
NOTE:
If there are any obligatory parameters missing, once you
click the Save button, the analyzer will automatically
red-frame the missing parameters (or pops up a dialog box
to warning you about it) and disables the Save button. You
need to set the missing parameters and try to save the
settings again.
To delete a test
1 Go to the middle part of the tab and click the desired test.
2 Click the Delete button and a dialog box will pop up to ask you to confirm the
deletion.
3 Click the OK button to delete the test; click the Cancel button, for any reason,
to ignore the deletion.
NOTE:
Once you have confirmed to delete the selected test, the
analyzer will delete all the parameters, including the reagent
parameters, calibration parameters, and QC parameters,
related to the test. Ensure the right test is selected before
confirming the deletion.
4-46
To edit a test
1 Go to the middle part of the tab and click the desired test.
A dialog box will pop up to ask you whether to delete other parameters related
to this test.
If you click the OK button, the analyzer will save the changed parameters and
clear all other unchanged ones, including the corresponding reagent
parameters, calibration parameters, and QC parameters; if you click the
Cancel button, the analyzer will save the changed parameters and keep the
other related parameters unchanged.
NOTE:
Once you have clicked the OK button, the analyzer will
delete all the parameters, including the reagent parameters,
calibration parameters, and QC parameters, related to the
test. Ensure the right test is selected before confirming the
deletion.
The system allows you to import reagent parameters from an existing parameter file.
Only users who are permitted to edit assay parameters are allowed to import reagent
parameters. Up to 80 assays can be configured on the system, which include those
that already exist in the system or are newly imported.
4-47
Reagent volume
Sample volume
Test type
Reaction direction
Wavelength
Reaction time
Incubation time
2 Click Parameter, locate the parameter file, and then click Open.
All assays contained in the parameter file are displayed in the Available
Tests list.
3 Select assays in the in the Available Tests list and then click Add->. To
import all assays, click Add All->.
The selected assays are displayed in the Import Tests list.
4 If you want to abort importing, select assays in the Import Tests list and
then click <-Delete. To cancel all assays, click <-Delete all.
5 Confirm the assays that you desire to import and then click Import.
6 Click Close to close the dialog box.
4-48
4.2.1.2 Reference Range tab
Click the Reference Range tab to edit or view the expected means of the test, as
Figure 4-15 shows.
4-49
Parameter What it does How to set
Patient Defines expected Tick the patient group sequentially
Demographics means for patients of from No.1 and enter the desired year
(Figure 4-16) different ages. and month in the Years and Months
Maximum 6 patient columns to define the upper and lower
groups can be limits of the patient ages. Enter the
defined. desired upper and lower limits for the
age groups. You must not leave the
any box blank.
The first Years box is for the lower
limit of the age and the second Years
box is for the upper limit. Both the
entered values must be 0-150 and the
upper limit must be greater than or
equal to the lower limit.
For adult or pediatric patients older
than one year, you can only enter 0s
to both the Months boxes. In case of
patients younger than one year, enter
the lower limit into the first Months
and the upper limit into the Months
limit. Both the entered values must be
0-12 and the upper limit must be
greater than or equal to the lower limit.
Default (Figure For a given test and Enter the lower limit into the first box
4-17) sample type and and the upper limit into the second.
patient gender, You can leave either of the boxes, but
defines the expected not both the boxes, empty. If you
range of the test entered values into both the boxes,
results for patients of ensure that 0 ≤ lower limit <upper
all ages. limit.
The expected range
defined for a
particular patient
group supersedes
this default range.
4-50
Figure 4-17 Setting default expected range
NOTE:
In case of inappropriate settings, a dialog box will pop up to
alert you once you have clicked the Save button.
The Calculation tab is where you set the parameters related to such calculation.
4-51
Figure 4-18 Calculation tab
As Figure 4-18 shows, the Calculation tab consists of four major parts: the
parameters on the upper left, all the available tests on the upper right, calculation
formula on the middle and operating buttons on the bottom.
4-52
To check the parameters of a calculated test
1 Select the desire test from the Assays field, or click or
until the desired test is reached.
NOTE:
Click to go to the previous test.
3 Select the tests to be involved in the calculation from the Assays field.
4-53
4 Click the Add to List button to add the selected tests to the calculation list.
NOTE:
In case you add inappropriate tests to the calculation list by
mistake, click the Clear button to clear the list and then
re-select appropriate tests to add to the list.
5 Edit the calculation formula by clicking a selected test from the calculation
list and click the Add to Formula button to add the test to the Formula
field. Clicking the digit buttons (0-9) and operator buttons (+, -, and so
forth) to associate the test with appropriated digits and operators as
needed by the desired calculation formula. Repeat this step on every
selected test until the desired calculation formula is completed.
NOTE:
To clear a mistake, click the Clear Formula button to clear
the formula and re-edit it the right way.
Example: to edit ALT-AST+TP, first select ALT from the calculation list and
then click the Add to Formula button to add the test to the Formula field.
Click the – button to associate the ALT with the minus sign. Select AST
from the calculation list and click the Add to Formula button to add the
test to the Formula field, following the minus sign. Click the + button to
associate the AST test. Select TP from the calculation list and click Add to
Formula. Thus, the desired formula is completed.
6 Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
4-54
2 Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
3 Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
NOTE:
In case you add inappropriate tests to the calculation list by
mistake, click the Clear button to clear the list and then
re-select appropriate tests to add to the list.
To clear a mistake, click the Clear Formula button to clear
the formula and re-edit it the right way.
3 Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
4-55
Figure 4-19 Profile tab
As the figure shows, the Profile tab consists of three major parts: existing profiles
(groups) on the left, available tests (tests have no assigned reagent positions are
followed by a forbidden mark) on the right and operating buttons on the bottom.
4 Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
4-56
To delete a profile
1 Select the desired group from the pull down list of the Profile Name field
or from the Profile List field.
3 Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
To edit a profile
1 Select the desired group from the pull down list of the Profile Name field
or from the Profile List field.
2 Click the Edit button.
3 Select or de-select the tests as you need. The selected tests will be
followed by a green tick. Clicking the ticked test again may de-select the
test.
4 Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes.
4-57
Figure 4-20 Carryover tab
As the figure shows, the Carryover parameters screen consists of five major parts:
current reagents listed in the current field and wash solution type on the upper, the
reagents that may be affected (contaminated) by the current reagents listed in the
contaminated field and position settings on the lower, and operating buttons on the
bottom.
Note that the yellow reagents are the first reagents of the double-reagent tests and
the blue reagents are the second reagents of the double-reagent tests.
4-58
To clear the carryover settings of a reagent
1 Click the desired reagent from the current field and the selected reagent
will be followed by a green tick. Check the contaminated field and the
tests followed by a red tick are those that may be affected by the current
reagent.
2 Click the Clear button and you will see all the red ticks have disappeared.
You can set basic information of off-system tests at the Off-system tab. Refer to
4.3.4.1 Results tab for details regarding entering the test results manually.
As the figure shows, the Off-system tab consists of mainly three parts: the
parameters on the upper left, the tests on the upper right and the operating buttons
on the bottom.
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Parameter What it does How to set
Precision Defines how many decimal Enter the desired integer or click
places (0 - 6) the test result the button until the desired
should have. number is reached.
Units Selects one of the units for Select the desired unit from the
the test. pull down list.
Lower Limit Defines the lower limit of the Enter the desired into the edit
expected range of the test box.
result.
If you enter 0s for both the lower
and upper limits, it means no
specific range defined for the
test result.
Upper Limit Defines the upper limit of the Enter the desired into the edit
expected range of the test box.
result.
If you enter 0s for both the lower
and upper limits, it means no
specific range defined for the
test result.
Print No. Defines the user-assigned Enter the desired integer into
printing order. the edit box.
Full Name Defines full name of the test. Enter maximum 60 letters into
the edit box.
Property Defines property of the test. Select Quantitative or
Qualitative from the pull down
list.
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3 Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
4.2.2 Reagent
To enter the Reagent Parameters screen, click Parameters → Reagent, or press
F12.
NOTE:
If you are not authorized to change the reagent parameters, a dialog
box will pop up to ask you to enter the authorized user name and
password.
At the Reagent screen, Figure 4-22, you can see two tabs:
Reagent Disk
Inventory
The Reagents Disk tab is where you set the parameters regarding the reagents.
The Inventory tab is where you check the remaining reagents and print the checking
results.
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4.2.2.1 Reagent Disk tab
Click the Reagent Disk tab to edit or view the reagent disk status, as Figure 4-23
shows.
As the reagent disk diagram shows, the reagent disk has 50 reagent positions, 25 on
the inner circle and marked even number and another 25 on the outer circle and
marked odd numbers.
All the reagent positions are color-coded: white for the empty positions; green for the
positions occupied by reagents for the single-reagent tests; red for the positions
occupied by reagents for the double-reagent tests; blue for the positions (49 and 50)
occupied by distilled water. Note that you cannot use the two blue positions for other
purposes.
The list to the right of the reagent disk diagram displays all the tests that have been
set.
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Parameter What it does
the remaining reagent is enough for.
R2 Inventory Uses a color bar to display how much reagent left in the R2
bottle. The color can represent maximum 100ml of the reagent.
When the remaining reagent is still more than half of the bottle,
the color bar appears green; When the remaining reagent is
between 1/4 and 1/2 of the bottle, the color bar appears yellow;
When the remaining reagent is less than 1/4 of the bottle, and
the color bar appears red.
The box to the right of the color bar displays how many tests
the remaining reagent is enough for.
R1 Bottle Defines the bottle used by reagent 1.
R2 Bottle Defines the bottle used by reagent 2. Note that this parameter
is not available for single-reagent tests.
NOTE:
When you have set (not changed) the reagent position for a
test, the analyzer will automatically take the reagent bottle
volume as the volume of the remaining reagent.
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
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To clear the reagent positions set for a test
1 Click “▼” to the right of Rgt. Disk and select the desired virtual reagent
disk from the pull down list.
2 Select the desired test from the test list.
3 Click the Clear button to clear the reagent positions set for the selected
test.
NOTE:
Once you have clicked the Clear button, the analyzer will
immediately clear all the reagent positions set for the
selected test without asking you to confirm the clearing.
Ensure the right test is selected before clicking the Clear
button.
NOTE:
If some parameters are not set correctly, after you click the
Save button, the system will remind you.
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3 If you want to set the selected disk as the default reagent disk, click the
OK button; otherwise, click the Cancel button.
After you set the default reagent disk, the Reagent Disk tab and the
Inventory tab will display its reagent information.
NOTE:
Ensure you have opened the reagent bottles before checking the
remaining reagents.
1 Click the Reagent Disk tab, and then click the “▼” to the right of Rgt.
Disk and select the desired virtual reagent disk from the pull down list.
Refer to 4.2.2.1 Reagent Disk tab for details.
2 To select one reagent, click the desired reagent;
to select multiple discontinued reagents, press and hold CTRL and click
the desired reagents one by one;
to select multiple continue reagents, click the first reagent of the desired
ones then press and hold SHIFT and click the last reagent of the desired
ones.
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3 Click the Check button to view how much reagent is left in the selected
bottle and how many tests the remaining reagent is enough for.
NOTE:
The function is available only when an external reagent bar code
scanner is used.
1 Select the reagent(s) whose information you want to clear from the
reagent list.
2 Click the Delete button.
4.2.3 Calibration
The Calibration screen is where you set the parameters regarding calibrators and
calibrations and view the calibration results and parameters.
NOTE:
If you are not authorized to edit the calibration parameters, a dialog
box will pop up to ask you to enter the authorized user name and
password.
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At the Calibration screen, Figure 4-25, you can see the following tabs:
Calibrator
Rule
Result
Calibr. Param. Search
Click the Calibrator tab to display its contents, as Figure 4-26 shows. The tab
consists of 4 zones:
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Five virtual sample disks (Sample Disk1 - Sample Disk5) are displayed in the
Positions zone and every virtual disk has 6 calibrator positions (S1 - S6). The 0
position (default) means this virtual disk has no position set for the calibrator yet. You
cannot request a calibration run for a calibrator whose corresponding calibrator
positions on all the five virtual disks are 0s.
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2 The analyzer will automatically assign a number to the new calibrator and
you can only view in the No. field without altering it;
Enter calibrator name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click “▼” to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the calibrator;
Click “▼” to the right of Exp. Date and select the appropriate as the
expiration date of the calibrator.
NOTE:
Ensure the right expiration date is set so that the analyzer
can correctly judge whether the calibrator has expired.
3 Click the OK button to save the settings; Click the Cancel button, for any
reason, to ignore the settings.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have click the OK button.
2 Click the Edit button and the Calibrator window will pop up.
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3 The analyzer will automatically assign a number to the new calibrator and
you can only view in the No. field without altering it;
Enter calibrator name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click “▼” to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the calibrator;
Click “▼” to the right of Exp. Date and select the appropriate as the
expiration date of the calibrator.
4 Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
2 Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
3 Click the OK button to confirm the deletion; Click the Cancel button, for
any reason, to abort the deletion.
NOTE:
Once you have confirmed the deletion, the analyzer will
delete all the parameters, including calibrator positions, tests
included, etc., related to the selected calibrator. Ensure the
right calibrator is selected before confirming the deletion.
You cannot delete a calibrator involved in calibrations that
are in process or have been requested.
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To set or change positions of a specific calibrator
1 Select the desired calibrator from the Calibrators zone.
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2 Click the Concentration button and a Concentrations window will pop
up.
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4 Click the desired test in the Assays zone. The selected test will be
marked a green tick and click it again to de-select it. You can choose
multiple tests and set or delete their standard concentrations altogether.
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Figure 4-28 Rule tab
Click the Rule tab to display its contents, as Figure 4-28 shows. The tab consists of
4 zones:
Operating buttons zones – lists such buttons as Save, Cancel, Clear, etc.
Assays zone – lists all the available tests. Those tests followed by forbidden
mark, such as , have no reagent positions yet and you cannot set the
calibration parameters for them. The blue-framed tests are those whose
calibration parameters have already been set.
Rule zone – defines the nine parameters regarding calibration requests.
Calibrators zone – lists the calibrators that have already been set. The selected
calibrator will be preceded by a red tick; the expired calibrator will be preceded by
a red block.
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Parameter What it does How to set
K Factor Applies to One-point linear (K-factor) Enter the desired value
only. into the edit box.
When you set calibration parameters for
a test:
If the entered value is 0, a calibrator
whose concentration is not 0 must be
selected;
If the entered value is not 0 and no
calibrator is selected, the system will
calculate the concentration of sample
with the formula C=K*R (K is the K
factor and R is the response of sample)
without calibrating;
If the entered value is not 0 and a
calibrator whose concentration is 0 is
selected, the system will calculate the
concentration of sample with the
formula C=K*(R-Rs1) (K is the K factor;
R is the response of sample; Rs1 is the
response of the 0-concentration
calibrator) after calibrating.
Rerun Defines for how many times (1-5) the Enter the desire
Error Limit calibration test should be rerun. The integer(1-5) into the
default value is 1. edit box to the right of
Rerun Error Limit or
If the entered value is 2, the analyzer
will take average of the two runs as the click button on the
final result; right of the edit box
until the desired value
If the entered value is 3, the analyzer is reached.
will first remove the one with the largest
deviation and then take average of the
remaining two runs as the final result;
If the entered value is 4 or 5, the
analyzer will first remove the largest
and the smallest results and take
average of the remaining results as the
final result.
Difference Defines the maximum difference Enter the desired value
between the largest response and the (0-2.5) into the edit box
smallest response. Once the actual to the right of
difference exceeds this value, the Difference.
system will alert the user. The entered
value should be no less than 0 and no
greater than 2.5. The default value is 0,
meaning you do not want to do this
check.
Interval Defines the interval (0-99 days) Enter the desired
between two adjacent auto calibrations. integer (0-99) into the
The default value is 0, indicating you do edit box to the right of
not need the analyzer to remind you of Interval or click on
the next calibration. the right of the edit box
until the desired value
is reached.
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Parameter What it does How to set
Blank Defines the response upper limit (0-2.5) Enter the desired value
Response for the 0-concentration calibrator. The (0-2.5) into the second
system will alert the user once the blank edit box to the right of
result exceeds this limit. The default Blank Response.
value is 0, meaning you do not want to
do this check.
Sensitivity Defines the maximum difference Enter the desired value
between the response of the into the edit box to the
largest-concentration calibrator and that right of Sensitivity.
of the smallest-concentration calibrator.
The system will alert the user once the
actual difference exceeds this limit.
The default value is 0, meaning you do
not want to do this check.
Difference Defines the difference between the Enter the desired value
Limit calibration factors (slope of the into the edit box to the
calibration curve) of current and last right of Difference
calibrations ((Current-Last)/Last). It only Limit.
applies to multi-point linear calibrations.
The default value is 0, meaning you do
not want to do this check.
Coefficient Applies only to multi-point linear or Enter the desired value
non-linear calibrations. The valid value into the edit box to the
is 0-1. The default value is 0, meaning right of Coefficient.
you do not want to do this check.
SD Applies only to non-linear calibrations. Enter the desired value
The fault value is 0, meaning you do not into the edit box to the
want to do this check. right of SD.
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2 Select the desired test to view its calibration settings.
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5 Select the calibrator or calibrators and the selected calibrator or
calibrators will be preceded by a red tick.
NOTE:
Calibrators with same concentration must not be selected for
the same assay.
You must determine the number of the calibrators to be used
according to the selected calibration rule. You can only
select calibrators whose standard concentrations have
already been set. The table bellows shows the
correspondence between calibration rule and number of
calibrators.
Calibration Number of
Rule Calibrators
One-point 1
linear
Two-point 2
linear
Multi-point 3≤n≤10
linear
Logistic-Log4P 4≤n≤10
Logistic-Log5P 5≤n≤10
Exponential5P 5≤n≤10
Polynomial5P 5≤n≤10
Parabola 3≤n≤10
Spline 2≤n≤10
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6 Click the Dilution button and the Calibrator Dilution Setup window will
pop up.
Dilution is only applied to calibration rules rather than one-point linear, and
to calibrators with non-zero concentration.
7 Enter dilution parameters in the text boxes.
Concentration: means the concentration of the diluted calibration. It
will be used for calculating calibration parameters and must not be
duplicate for the same assay.
Dilution sample volume: means the volume of the calibrator used for
diluting. It ranges from 3 to 45μl with increment of 0.5μl.
Diluent volume: means the volume of the diluent used for diluting. It
ranges from 90 to 450μl with increment of 1μl.
Sample volume: means the volume of the calibrator used for
analyzing. It ranges from 3 to 45μl with increment of 0.5μl.
The total amount of the diluted mixture should be within 180-495μl.
8 Click the Save button to save the settings; Click the Cancel button to
ignore the settings. Then click Close to exit the window.
When finishing the dilution setup, the Rule screen displays calibrator
concentrations in the format of “XX-XX-XX” as the settings. “XX” refers to
the concentration of the diluted calibrator.
9 Click the Save button to save the changes; Click the Cancel button, for
any reason, to ignore the changes.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
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To clear calibration settings of a specific test
1 Select the desired calibration rule.
2 Select the test or tests whose calibration settings you want to clear.
NOTE:
Once you have clicked the Clear button, the analyzer will
immediately clear all the calibration settings related to the
selected test without asking you to confirm the clearing.
Ensure the right test is selected before clicking the Clear
button.
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Figure 4-29 Result tab
NOTE:
If no calibration run matches the specified conditions, a
dialog box will pop up to remind you no match is found.
Under this circumstance, go directly to step 6.
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4 If you do not intend to check the calibration curve, go directly to step 6;
Otherwise, click the Calib. Curve button to enter the Calibration Curve
window to view the calibration result.
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7 Select the desired calibration rule from the pull down list to the left of
Method.
8 Click the Calculate button to start the calculation; click the Cancel button,
for any reason, to cancel the calculation.
NOTE:
You cannot select the calibration whose Default field
displays Yes.
5 Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
6 Click the OK button to confirm the deletion; click the Cancel button, for
any reason, to cancel the deletion.
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To define the default settings
1 To specify the search conditions:
Click “▼” to the right of Assay, or click or to check previous
or next test until the desired one is reached;
Click “▼” to the right of From (or To) and select the desired date to
specify the dates to be searched. The analyzer will search all the
calibration runs taking place during this specified period.
2 Click the Lock button to lock the selected search conditions.
3 Click the Search button to start the search and the matches will be
displayed in the Results area. You can’t go on unless there are matches.
4 Select the desired record from the Calibrations field.
5 Click the Default button to set the current calibration settings as the
default settings of the selected test. The Default field of the calibration will
display Yes.
NOTE:
This analyzer uses the default calibration settings to
calculate the sample concentrations.
This analyzer will automatically set the latest settings
(include the settings of calibration test, edit, calculation) as
the default.
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5 Click the Data button. The Test Data dialog box is displayed. You can
view the data of selected calibration.
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8 Click the Close button to close the Reaction Curve window.
9 Click the Close button to close the Test Data window.
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To exit the calibration screen
1 Click the Close button to exit the Calibration screen.
4.2.4 QC
The QC screen is where you set the parameters regarding controls and QC runs and
view QC results.
NOTE:
If you are not authorized to change the QC parameters, a dialog box
will pop up to ask you to enter the authorized user name and
password.
At the QC screen, Figure 4-31, you can see the following tabs:
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4.2.4.1 Control tab
The Control tab is where you set parameters for the controls.
Click the Control tab to display its contents, as Figure 4-32 shows. The tab mainly
consists of 4 zones:
Controls zone – displays such control parameters as lot number, expiration date,
etc.
Positions zone – displays the positions of the controls.
Assays zone – displays available tests that related to the selected control in
Controls zone.
Operating buttons – such buttons as Add, Edit, etc.
Five virtual sample disks (Sample Disk1 - Sample Disk5) are displayed in the
Positions zone and every virtual disk has 3 control positions (C1 - C3). The 0
position (default) means this virtual disk has no position set for the control yet. The
Other means you can set other positions for the controls on the disk.
You cannot request a QC run for a control whose corresponding control positions on
all of the five virtual disks are 0s.
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To view positions and tests of a specific control
1 Click the desired control in the Controls zone and check its positions and
tests in the Positions and Assays zones respectively.
2 The analyzer will automatically assign a number to the new control and
you can only view in the No. field without altering it;
Enter control name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click “▼” to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the control;
Click “▼” to the right of Exp. Date and select the appropriate date as the
expiration date of the control;
Click “▼” to the right of Tube Type and select Large Tube or Small Tube
for the control.
NOTE:
Ensure the right expiration date is set so that the analyzer
can correctly judge whether the control has expired.
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3 Click the Save button to save the changes; Click the Cancel button, for
any reason, to ignore the change.
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have clicked the Save
button.
2 Click the Edit button and the Control window will pop up.
3 The analyzer will automatically assign a number to the new control and
you can only view in the No. field without altering it;
Enter control name into the edit box to the right of Name;
Enter the lot number into the edit box to the right of Lot No.;
Click “▼” to the right of Conc. Level and select Low, Normal or High
from the pull down list as the concentration level of the control;
Click “▼” to the right of Exp. Date and select the appropriate date as the
expiration date of the control;
Click “▼” to the right of Tube Type and select Large Tube or Small Tube
for the control.
4 Click the Save button to save the changes; click the Cancel button, for
any reason, to ignore the changes
NOTE:
If any field is inappropriately set, the analyzer will warn you
about the wrong settings once you have click the Save
button.
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To delete a specific control
1 Select the desired control from the Controls zone.
2 Click the Delete button and a dialog box will pop up to ask you to confirm
the deletion.
3 Click the OK button to confirm the deletion; Click the Cancel button, for
any reason, to abort the deletion.
NOTE:
Once you have confirmed the deletion, the analyzer will
delete all the parameters, including control positions, tests
included, etc., related to the selected control. Ensure the
right control is selected before confirming the deletion.
You cannot delete a control involved in QC runs that are in
process or have been requested.
The control positions that appear gray are occupied by other controls.
4 Click the Save Position button to save the changes.
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To set standard concentration and SD for a specific test
1 Select the desired control from the Controls zone.
2 Click the Concentration button and a Concentration window will pop up.
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4 If you enter concentrations and SDs for ISE tests, go directly to the next
step.
Click the desired test in the Assays zone. The selected test will be
marked a green tick and click it again to de-select it. You can choose
multiple tests and set or delete their standard concentrations or SD
altogether.
NOTE:
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Figure 4-33 Rule tab
Click the Rule tab to display its contents, as Figure 4-33 shows. The tab consists of
3 zones:
Independent zone
Control-related zone
Operating buttons zone
The QC rules can be divided into two categories: independent rules, such as
Cumulative Sum Check and Westgard Multi-rule, and control-related rules (not
related to controls), such as Accumulative Error and X-R. Note that you cannot set
the parameters of the control-related rules unless you have specified the controls to
be used.
As Figure 4-34 shows, all the available tests are listed on the left and the rules,
Cumulative Sum Check and Westgard Multi-rule, are listed on the right. The
Cumulative Sum Check rule has three sub-rules and you can choose one of the
sub-rules. The Westgard Multi-rule rule has six sub-rules and you can choose one
or more sub-rules.
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Figure 4-35 Control-related zone
As Figure 4-35 shows, all the available tests are listed on the left and the QC rule
parameters are listed in the Control, Accumulative Error and X-R zones.
Note that any test whose standard concentration and SD have not been set yet will
be followed by a forbidden mark, such as .
NOTE:
If the ISE unit (optional) is connected, the ISE tests will be displayed in
the test list.
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4 Click the option to the left of the desired sub-rule.
5 Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
6 Repeat from step 2 to set the parameters for other tests, or click the check
box to the left of Independent again to de-select the field.
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4 To set the parameters: click “▼” button to the right of Control and select
the desired control from the pull down list; enter the desired E (limit of the
accumulated error) into the edit box to the right of Limit(E); enter the
desired SDR value in the edit box to the right SDR (for the X-R rule).
5 Click the Save button to save the settings; click the Cancel button, for any
reason, to ignore the settings.
6 Repeat from step 2 to set the parameters for other tests, or click the check
box to the left of Control-related again to de-select the field.
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Controls zone – lists all the available controls.
Auto QC zone – defines parameters regarding auto QC.
Operating buttons – lists such buttons as Save, Clear, etc.
The tests, whose QC parameters have already been set, are blue-framed. The tests
whose reagent positions have not been set yet are followed by a forbidden mark,
such as , and you cannot set QC parameters for the test.
All the controls that have been set are listed in the Controls zone. The selected
tests will be preceded by a red tick and the expired test will be preceded by a red
mark.
You can set the interval of the automatic QC runs by entering the desired number
into the edit box below Count or clicking on the right of the edit box until the
desired number is reached. To disable the auto QC function, enter 0 into the edit
box.
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3 Select the controls to be used.
5 Click the Save button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
NOTE:
If any parameter is inappropriately set, the analyzer will alert
you after you have clicked the Save button.
NOTE:
Once you have clicked the Clear button, the analyzer will
immediately clear the QC settings related to the selected test
without asking you to confirm the clearing. Ensure the right
test is selected before clicking the Clear button.
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4.2.4.4 Real-time Result tab
The Real-time Result tab is where you view and print the real-time QC results and
delete the real-time QC data.
NOTE:
If the ISE unit (optional) is connected, ISE tests will be displayed in the
test list.
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2 Tick the desired control or controls.
3 Click the Search button to display the information, including the results,
QC graph, statistic data and QC status, of the last 10 control runs of the
selected test using the selected control or controls.
To print the displayed data and graph, click the Print button.
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3 Click the Data button. The Delete QC Data dialog box is displayed. You
can view and delete the measurement data of selected control.
4 Select one or more QC results you want to delete from the Delete QC
Data dialog box.
5 Select Delete. The Enter User and Password dialog box pops up.
6 Enter correct user name and password and click OK. The selected results
are deleted.
Please note that the username you are entering should have the authority
to set up quality control. Otherwise you cannot delete the QC results.
7 Click the Close button to exit the Delete QC Data window.
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Figure 4-38 Daily Result tab
NOTE:
If the ISE unit (optional) is connected, ISE tests will be displayed in the
test list.
3 Select the desired test from the Assays zone. The selected test will be
followed by a green mark.
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4 Tick the desired control or controls.
5 Click the Search button to display the information, including the results,
QC graph, statistic data and QC status, of the last 10 control runs of the
selected test using the selected control or controls.
To print the displayed data and graph, click the Print button.
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3 Click the Data button. The Delete QC Data dialog box is displayed. You
can view and delete the measurement data of selected control.
4 Select one or more QC results you want to delete from the Delete QC
Data dialog box.
5 Select Delete. The Enter User and Password dialog box pops up.
6 Enter correct user name and password and click OK. The selected results
are deleted.
Please note that the username you are entering should have the authority
to set up quality control. Otherwise you cannot delete the QC results.
7 Click the Close button to exit the Delete QC Data window.
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Figure 4-39 Day-to-day Result tab
NOTE:
If the ISE unit (optional) is connected, ISE tests will be displayed in the
test list.
3 Select the desired test from the Assays zone. The selected test will be
followed by a green mark.
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4 Tick the desired control or controls.
5 Click the Search button to display the information, including the results,
QC graph, statistic data and QC status, of the last 10 control runs of the
selected test using the selected control or controls.
To print the displayed data and graph, click the Print button.
3 Click the Data button. The Delete QC Data dialog box is displayed. You
can view the measurement data of selected control.
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4 Click the Close button to exit the Delete QC Data dialog box. window.
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NOTE:
If the ISE unit (optional) is connected, ISE tests will be displayed in the
test list.
4.3 Data
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4.3.1 Export
Click Data → Export or press CTRL + F to enter the Data exported screen, as
Figure 4-41 shows.
NOTE:
This analyzer automatically backs up its settings and test results.
Exporting data refers to saving some data to a file (.SHD file)
temporarily so that the data can be transmitted or updated. It is not the
same as backing up the database.
We recommend this exporting function not be used unless it is
necessary.
As Figure 4-41 shows, the Data exported screen consists of the following fields:
Assay
Calibration
QC
Sample
Others
Assays
Separator
The item in blue font listed in the Assay, Calibration, QC and Sample fields is
test-related and you can select test in the Assays field for these items.
NOTE:
If the data to be exported includes the data of last year, we
recommend the Start date be not before November 1. Otherwise, you
may not get the complete data.
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To select all the items
1 Click the All button to select all the items.
To export data
1 Select the items to be included in the exported data as instructed below.
Tick the check box to the left of the desired item to include it.
For the items in black font, they can be included into the exported data
simply by ticking the corresponding check boxes.
For the items in blue font, ticking their corresponding check boxes means
they apply to all the available tests. If you only intend to apply them to
certain tests, first specify the corresponding fields in the Applied to field and
then select the desired tests from the Assays field. See the examples below
for details.
Example1:
Follow the steps below to select: a) calculated tests (Calculation of the
Assay field) and units (Units of the Assay field) for all the tests; b) test
parameters (Parameters of the Assay field) for AST and ALP only.
(1) Tick the check boxes to the left of Parameters, Calculation, and Units
in the Assay field respectively.
(2) Tick the check box to the left of Assay in the Applied to field.
(3) Tick the check boxes to the left of AST and ALP in the Assays field
respectively.
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Example2:
Follow the steps below to select: a) calibration parameters (Results in the
Calibration field) for all the tests; b) calibration results (Test Data in the
Calibration) for the tests analyzed on February 3, 2007 and February 4,
2007 only.
(1) Tick the check boxes to the left of Results and Test Data in the
Calibration field respectively.
(2) Select February 3, 2007 from the pull down list to the left of the From in
the Calibration field.
(3) Select February 4, 2007 from the pull down list to the left of To in the
Calibration field.
Example3:
Follow the steps below to select the UR results of the samples: a) sample
IDs are 1 - 10; b) analyzed on February 3, 2007 and February 4, 2007.
(1) Tick the check boxes to the left of Results in the Sample field
(2) Enter 1 and 10 into the edit boxes to the right of Sample No.
respectively.
(3) Select February 3, 2007 from the pull down list to the left of the From in
the Sample field.
(4) Select February 4, 2007 from the pull down list to the left of To in the
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Sample field.
(5) Tick the check box to the left of Sample in the Applied to field.
(6) Tick the check box to the left of UR in the Assays field.
2 Click the Export button and a dialog box will pop up.
3 Select the desired directory and file and click the Save button to save the
data. You may also click the Cancel button to cancel the exporting.
4.3.2 Import
Click Data → Import or press CTRL + E to enter the Import Data screen, as Figure
4-42 shows. Note that you need a user name and password of the administrator
authority to enter the screen.
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Figure 4-42 Import Data screen
NOTE:
The imported data will overwrite the corresponding data in the
analyzer’s database. Before importing data, ensure the corresponding
data is exported to another file. You can only import data from .SHD
files.
We recommend this importing function not be used unless necessary.
To import data
1 Click the File button and a dialog box will pop up.
2 Select the desired file and click the Open button to open the selected file.
3 Click the Import button to import the data into the database. A dialog box
will pop up when then importing is done. Click the OK button to close the
box.
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To exit the Import Data screen
1 Click the Close button to exit the Import Data screen.
4.3.3 Demographics
Click Data →Demographics or press CTRL + A to enter the Demographics screen,
as Figure 4-43 shows. You can set patient information and add manual samples at
the screen.
As Figure 4-43 shows, you can click (to the first patient), (to the
previous patient), (to the next patient) or (to the last patient) to
select the desired patient.
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3 Enter the patient information of the sample.
The Date and the Sample No. cannot be changed.
The Sample ID can be entered manually.
4 If you want to save the new manual sample, click the Save button;
otherwise, click the Cancel button.
NOTE:
The default setting is only available at the current screen. If you click
the Exit button to close the Demographics screen, the default setting
disappears and you need to set it again when you enter the screen the
next time.
If you edit the patient information of a sample, you can insert a step between the
step 3 and step 4 of “To edit the patient information”: click the Load Default button.
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To exit the Demographics screen
1 Click the Close button to exit the Demographics screen.
4.3.4 Result
Click Data → Result or press Ctrl + R to enter the Results & Statistics screen, as
Figure 4-44 shows.
At the Result & Statistics screen, you can see the following tabs: Results, Result
Statistics and Test Statistics.
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Figure 4-45 Results tab
NOTE:
In case of a year-to-year search, the start date must not be
earlier than November 1st of the previous year.
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3 Click the Search button to start the search and the matches will be
displayed.
NOTE:
If no sample run matches the specified conditions, a dialog
box will pop up to remind you no match is found.
4 Click the By Sample, and then select a sample to view its results.
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To view reaction curve
1 Search for the sample results. Refer to the previous section To view
sample results for details.
2 Select a sample run.
If you select By Sample, select a sample and then a run.
3
NOTE:
You will see the Reaction Curve button except that you
select LIS in the Option field.
Click the Reaction Curve button to check the reaction curve and data of
the selected blank runs.
There are two tabs at the Reaction Curve screen, the Reac. Curve tab
and the Reac. Data tab. Click the former to check the curve and the latter
to check the data.
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4 If you do not want to check the results of other runs, go directly to the next
step;
Otherwise, click the Previous or Next button to check other runs (blanks,
samples, controls, or calibrations); or click the Close button and repeat
from step 2.
5 Click the Close button to close the Reaction Curve window.
2 Click the Print Setup button to enter the Printing Setup screen. Refer to
4.4.7 Print for details.
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4 Select the sample or samples you want to print. You can select them by
clicking the Select button or ticking the check boxes directly.
NOTE:
Click the Select button, and a dialog box will pop up to ask
you to enter the start number of the sample.
1 Search for the sample results. Refer to the previous section To view
sample results for details.
2 Select By Sample.
3 Click the option button to the left of Print in the Option field.
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4 Select the sample or samples (5 is the maximum) you want to print. You
can select them by clicking the Select button or ticking the check boxes
directly.
5 Click the Combined Print button to pop up the Print Preview screen.
6 If you have intended to print out all the results, go directly to the next step;
Otherwise, click the Selected Assay button in the preview window to
select the tests to be printed out. Then after clicking the OK button, click
the Hide Assays button.
7 At the Print Preview screen, you may choose Pr. Series (series printing)
for your impact printer; you may choose Pr. Current (printing current
page) or Pr. All (printing all pages) for other types of printers.
8 When you finish printing, click the Close button to exit the Print Preview
screen.
NOTE:
Click the Select button, and a dialog box will pop up to ask
you to enter the start number of the run.
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5 Click the Print button to pop up the Print Preview screen.
At the Print Preview screen, you may choose Pr. Series (series printing)
for your impact printer; you may choose Pr. Current (printing current
page) or Pr. All (printing all pages) for other types of printers.
6 When you finish printing, click the Close button to exit the Print Preview
screen.
NOTE:
The To (end date) must be in the current year. Otherwise,
you cannot edit manual results.
2 Select By Sample.
3 Click the option button to the left of the middle Edit in the Option field.
7 If you want to save the setting, click the Save button; otherwise, click the
Cancel button.
NOTE:
Sample results can only be edited by authorized personnel.
If an unauthorized personnel wants to edit sample results, a dialog box
will pop up to ask you to enter authorized user name and password.
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1 Search for the sample results. Refer to the previous section To view
sample results for details.
NOTE:
The To (end date) must be in the current year. Otherwise, you
cannot edit sample results.
2 Select By Sample.
3 Click the option button to the left of the right Edit in the Option field.
4 Select a sample.
8 If you want to save the setting, click the Save button; otherwise, click the
Cancel button.
NOTE:
Sample results can only be revised by authorized personnel.
If an unauthorized personnel wants to revise sample results, a dialog
box will pop up to ask you to enter authorized user name and
password.
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1 Search for the sample results. Refer to To view sample results for details.
NOTE:
The End (end date) must be in the current year. Otherwise,
you cannot revise sample results.
2 Select By Test.
3 Click the option button to the left of Correct in the Option field.
7 If you want to revise the results, click the Save button; otherwise, click the
Cancel button.
NOTE:
The To (end date) must be in the current year. Otherwise, you
cannot send sample results to the LIS in batch mode.
2 Select By Sample.
3 Click the option button to the left of LIS in the Option field.
4 Select a sample or samples. You can select them by clicking the Select
button or ticking the check boxes directly.
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5 Click the Send button to send the results of the selected samples to the
LIS.
When the results are sent, a dialog box will pop up.
NOTE:
There are two modes to send information to the LIS, the real-time
mode and the batch mode.
You can send information to the LIS in batch mode at any time only
except that when you select the Real Time Send at the System
SetupÆHost Communication screen and the system is testing.
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As Figure 4-46 shows, the search conditions are listed on the upper left of the
screen, such statistic data as SD and Mean on the lower left, expected range on the
upper right and statistic graph on the middle right.
NOTE:
To specify the age range of the patients, enter the lower limit
of the range into the edit box to the right of Age Lower Limit
and the upper limit into the edit box to the right of Age
Upper Limit.
If you enter 0s into both the boxes, it means there is no
specific requirement on the ages.
2 Click the Search button and the analyzer will search for the matches and
present a statistic graph of the results found.
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4.3.4.3 Test Statistics tab
The Test Statistics tab is where you view the summary of the tests and the
reagents.
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4.4 System
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Figure 4-48 System Status screen
Status
Others
As Figure 4-49 shows, you can check the status of the major components of the
analyzer.
Note that the light intensity of the lamp is expressed in Photometer Lamp. The bar
to the right of the Photometer Lamp represents the light intensity of the lamp in
term of percentage, light intensity of a new lamp being 100%. When the light
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intensity is normal, the bar is green. When the light intensity is more than 50%, the
bar is yellow. When the lamp is to be changed, the bar is red. If the system does not
detect the light of the lamp, the bar is white.
As Figure 4-50 shows, you can not only view the dark currents of various
wavelengths, but also check the movement of the cuvette loader and wash the
sample and reagent probes and mixing bar.
The list shows the dark currents and backgrounds of the nine wavelengths and one
reference wavelength. The dark current refers to the AD output of the wavelength
when the lamp of the photometer is not switched on. The backgrounds refer to the
AD outputs generated by the lights when there are no cuvettes in the optical paths.
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To wash the sample and reagent probes and the mixing bar
1 When the analyzer is on standby, click the Enhanced Wash button and
the analyzer will use acid and alkaline detergents to wash the sample and
reagent probes and the mixing bar.
4.4.2 Setup
The System Setup screen is where you set options regarding the routine settings,
reruns, test units and LIS connection.
To enter the System Setup screen, click System → Setup, or press Ctrl + F3. A
dialog box shown as the figure below will pop up.
Click Cancel and a dialog box will then pop up to ask you to enter your user name
and password. You must have the corresponding authority to enter the System
Setup screen.
NOTE:
Only authorized personnel can enter the System Setup screen.
At the System Setup screen, shown in Figure 4-51, you can see the following tabs:
Routine
Rerun
Units
Host Communication
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4.4.2.1 Routine tab
As Figure 4-51 shows, there are several fields you can set at the Routine tab.
Follow the instructions given below to do so.
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Field What it does How to set
Manual Bar Code If it is selected, you must enter Click the check box to
Scanner the bar code information when tick this option and click
requesting a sample. it again to cancel the
selection.
NOTE:
Set a suitable value for the insufficient reagents alarm so that the
analyzer can alert you about insufficient reagents in time.
When you have finished setting the desired fields, click the Save button to save the
changes. A dialog box will then pop up to remind you the settings are saved, as
Figure 4-52 shows. Click the OK button to close the dialog box.
If you entered an improper value for any field, a dialog box will pop up to warn you
about the wrong setting after you clicked the Save button, as Figure 4-53 shows.
Seeing the dialog box, click OK button to close it and re-enter a proper value for the
field in question (insufficient reagents alarms, in case of Figure 4-53) and then save
the settings again.
When you have finished setting, you can click the Close button to exit the System
Setup screen.
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4.4.2.2 Rerun tab
Click the Rerun tab to view the 9 available fields in it, as Figure 4-54 shows. Follow
the instructions given below to set them.
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Field What it does How to set
Beyond Response Instructs the analyzer to Click the check box to the
Range re-dilute and then rerun right of Beyond Response
the sample if the result of Range to select it; re-click
the previous run is the check box to de-select
beyond the allowed it.
response range.
Substrate out Instructs the analyzer to Click the check box to the
(Kinetic and Fixed re-dilute and then rerun right of Substrate out
Time) the sample if the Kinetic and Fixed Time) to
substrate ran out during select it; re-click the check
the previous sample run. box to de-select it.
It only applies to the runs
employing Kinetic or
Fixed Time methods.
Surplus Antigen Instructs the analyzer to Click the check box to the
re-dilute and then rerun right of Surplus Antigen to
the sample if the surplus select it; re-click the check
antigen was found during box to de-select it.
the previous sample run.
No Balance Point Instructs the analyzer to Click the check box to the
(Endpoint) re-dilute and then rerun right of No Balance Point
the sample if no balance (Endpoint) to select it;
point was detected during re-click the check box to
the previous sample run. de-select it.
It only applies to the
sample runs employing
Endpoint method.
If no dilution parameters
are set for a test, the
sample run of it will not be
rerun automatically even if
no balance point is
detected.
When you have finished setting the desired fields, click the Save button to save the
changes. A dialog box will then pop up to remind you the settings are saved, as
Figure 4-55 shows. Clicks OK button to close the dialog box.
If you entered an improper value for any filed, a dialog box will pop up to warn you
about the wrong setting after you clicked the Save button. Seeing the dialog box,
click OK to close it and then re-enter a proper value for the field in question and then
save the settings again.
When you have finished settings, you can click Close to exit the System Setup
screen.
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4.4.2.3 Units tab
Click the Units tab (Figure 4-56) to set the units that will be used for the tests. Note
that all the units to be selected at other screens must be entered here.
Follow the instructions given below to add, edit or delete test units.
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NOTE:
Once you click the Delete button, the software will immediately delete
the selected unit without asking you to confirm the deletion. Ensure the
right unit is selected before clicking the Delete button.
NOTE:
If you have no LIS server, the function of the screen is unavailable.
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the LIS server manually.
If you select Apply Sample ID from LIS, the system will use the sample
ID downloaded from the LIS host rather than that in the operating
software. If the downloaded sample ID is duplicate or not consistent with
the sample bar code, you will be prompted. Please operate as instructed
by the prompt information.
2 For the same sample, if the information downloaded from the LIS server is
different from the existing, selecting Neglect means the system will ignore
the information downloaded repeatedly, selecting Overwrite means the
system will overwrite the existing information with the new, and selecting
Add means the system will add the newly-downloaded test information to
the existing ones.
3 Enter the IP address of the server on the right of IP Address in the Host
Computer field.
4 Enter the port on the right of Port in the Host Computer field.
5 Select a LIS protocol in the LIS Protocol field. The options include:
HL7
DMS-HL7
ASTM
6 Click the Save button to save the settings.
NOTE:
There are two modes to send information to the LIS, the real-time
mode and the batch mode.
You can send information to the LIS in batch mode at any time only
except that when you select the Real Time Send at the System
Setup screen and the system is testing.
NOTE:
If the system is not connected to the LIS, the Test and the Connect
buttons are available; otherwise, the Disconnect button is available.
1 If you do not want to check the connection between the system and the
LIS, go directly to the next step;
Otherwise, click the Test button to check the network connection. The
system will pop up a dialog box to tell you whether the connection is
successful.
2 If you want to connect the system to the LIS, click the Connect button;
Otherwise, click the Disconnect button.
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4.4.3 Hospital
The Hospital Information screen is where you set the options regarding the
hospital and doctors.
To enter the Hospital Information screen, click System → Hospital, or press CTRL
+ H. A dialog box will then pop up to ask you to enter your user name and password.
You must have the administrator authority to enter the Hospital Information screen.
NOTE:
You need the administrator authority to enter the Hospital
Information screen.
At the Hospital Information screen, shown in Figure 4-58, you can see three tabs:
Hospital
Doctors
All Doctors
Follow the instructions given below to set them.
As Figure 4-58 shows, you can set hospital name and departments at this tab. The
hospital name you set here will appear on the patients’ assay reports, and all the
departments to be selected at other screens must be entered here.
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To add a new department
1 Click the Add button in the Department field.
2 Enter the desired department name in the edit box to the right of
Department.
3 Click the Save button in the Department field to save the entered name;
Click the Cancel button, for any reason, to discard the entered name.
NOTE:
Once you click the Delete button, the analyzer will immediately delete
the selected department, as well as all the doctors (see the next
section) belonging to this department without asking you to confirm the
deletion. Ensure the right department is selected before clicking the
Delete button.
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4.4.3.2 Doctors tab
Click the Doctors tab to show the available fields, as Figure 4-59 shows. All the
doctors to be selected at other screens must be entered here.
There are four buttons at the middle part of the Doctors tab, as Figure 4-60 shows.
Button Function
Displays the information of the first doctor of the selected
department.
Displays the information of the previous doctor of the selected
department.
Displays the information of the next doctor of the selected
department.
Displays the information of the last doctor of the selected
department.
If there is no existing doctor information in the selected department, the arrows will
appear gray, indicating they are not usable at this moment.
Follow the instructions given below to add, edit or delete doctors to a selected
department.
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To add a new doctor
1 Click “▼” to the right of Dept. to display the pull-down list and select the
desired department.
2 Click the Add button and the analyzer will automatically assign a number
to the new doctor. Note that you cannot change this number.
3 Enter the doctor’s name in the edit box to the right of Name.
4 Enter the doctor’ s duty into the edit box to the right of Duty.
5 Click the Save button to save the change; Click the Cancel button, for
any reason, to ignore the change.
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To delete the information of an existing doctor
1 Click “▼” to the right of Dept. to display the pull-down list and select the
desired department.
2 Click the arrows to find the desired doctor information if necessary.
3 Click the Delete button to delete the information of the selected doctor.
NOTE:
Once you click the Delete button, the analyzer will immediately delete
doctor from the selected department without asking you to confirm the
deletion. Ensure the right doctor is selected before clicking the Delete
button.
Click the All Doctors tab to view all the saved doctor information, as Figure 4-61
shows.
To view the information of all the doctors, you can click “▼” to the right of Dept. and
select All departments.
To view the information of doctors of a specific department, click “▼” to the right of
Dept. and select the desired department.
You can click the Close button to exit the Hospital Information screen.
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4.4.4 User
Click System → User or press CTRL + B and a dialog box will pop up, as Figure
4-62 shows, to ask you to enter the appropriate user name and password.
Figure 4-62 A dialog box to ask you enter the appropriate user name and password
Enter a user name and a password of the administrator authority to enter the User
Management screen, as Figure 4-63 shows.
NOTE:
Only users of the administrator authority can enter the User
Management screen.
As Figure 4-63 shows, you can check the existing users or user groups at the User
Management screen.
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2 Enter the necessary user information as instructed below.
User: Enter the maximum 15 letters or digits into the edit box as the user
name.
Description: Enter additional information regarding the user’s duty, title or
the like.
Password: Enter the password to be used by the user.
Confirm: Re-enter the password here to confirm the entry.
Authority: Assign the new user to an existing user group or groups. Click
button to add the new user to all the existing user groups; click
to remove the new user from all the existing groups; click
button to add the new user to a selected group or groups; click to
remove the new user from a selected group or groups.
Department: Select the department the new user belongs to.
Operator: Select the new user’s name from the pull down list.
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3 Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
3 Click the OK button to confirm the deletion; click the Cancel button to
abort the deletion.
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To change the user name and password of the administrator
1 Click User Management → Change Admin. Password and a dialog box
will pop up to ask you to enter the user name and password of the
administrator authority.
2 Enter the user name and password as required and click the OK button
and another dialog box will pop up to ask you to enter the new user name
and password.
4 Click the OK button to save the changes; click the Cancel button, for any
reason, to ignore the changes.
4.4.5 Log
Click System → Log or press CTRL + F2 to enter the Log Management screen, as
Figure 4-64 shows.
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Figure 4-64 Log Management screen
As Figure 4-64 shows, the Log Management screen lists as many as 300 alarm
messages. Once the saved alarm messages reach 300, the analyzer will
automatically save the messages into a .log file and the file name is the saving time.
Look in:
Files of Type:
Cancel
2 Select the desired log file from the “Log” folder under the directory the
operating software is installed and click the Open button to open the
selected log file.
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2 Click the OK button to save the log and then clear it; click the Cancel
button to clear the log without saving it.
4.4.6 Maintenance
Click System → Maintenance or press CTRL + Q and a dialog box will pop up, as
Figure 4-65 shows, to ask whether you are maintenance personnel.
Figure 4-65 A dialog box to ask you whether you are maintenance personnel
Click the Cancel button and another dialog box will pop up to ask you to enter the
appropriate username and password, as Figure 4-66 shows.
Figure 4-66 A dialog box to ask you to enter username and password
Enter a username and password of the administrator authority to enter the System
Maintenance screen, as Figure 4-67 shows.
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Figure 4-67 System Maintenance screen
At the System Maintenance screen, the Sent Instructions field and the Received
Data field respectively display the instruction codes sent to the Analyzing Unit and
received by the Operation Unit.
NOTE:
Do not perform any maintenance action unless you are certain the
analyzer is on standby.
To lock data
1 If you feel the codes displayed in the Sent Instructions and Received
Data fields refresh too fast, click the Lock button, which then will become
the Unlock button, and the displayed data will stop changing. You can
click the Unlock button to resume the data refreshing.
To clear data
1 Click the Clear button to clear the Sent Instructions and Received Data
fields.
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4.4.6.1 S. Probe tab
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NOTE:
Ensure the sample disk is placed in the home position or stopped at
certain tube position before clicking Into Inner Circle or Into Outer
Circle button. Otherwise, it may lead to probe collision.
Ensure the reaction disk is placed in the home position or stopped at
certain cuvette position before clicking Into Cuvette button.
Otherwise, it may lead to probe collision.
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Button What it does
Above Reaction Disk Click this button and reagent probe will move to a
position above the dispensing hole of the reaction
disk.
Into Cuvette Click this button and the reagent probe will lower into
the reaction cuvette and stop when it contacts the
liquid surface or the reaction cuvette bottom.
NOTE:
Ensure the reagent disk is placed in the home position or stopped at
certain reagent position before clicking Into Inner Circle or Into Outer
Circle button. Otherwise, it may lead to probe collision.
Ensure the reaction disk is placed in the home position or stopped at
certain cuvette position before clicking Into Cuvette button.
Otherwise, it may lead to probe collision.
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Button What it does
Above Reaction Disk Click this button and the mixing bar will move to a
position above the mixing hole of the reaction disk.
Into Cuvette Click this button and the mixing bar will lower into the
reaction cuvette.
Mix Enter the desired integer into the edit box to the right
of Time and click the Mix button to lower the mixing
bar into the reaction cuvette and mix the specified
time (expressed in terms of units and every unit
stands for 20ms).
NOTE:
Ensure the reaction disk is placed in the home position or stopped at
certain cuvette position before clicking Into Cuvette or Mix button.
Otherwise, it may lead to bar collision.
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Button What it does
Rotate Given Circles to Enter the desired number into the edit box below
Given Position Circles to specify how many circles the reaction
disk should run. Enter the desired number (1-80)
into the edit box below Position to specify at
which cuvette position the reaction disk should
stop.
Click this button and the reaction disk will rotate
the given circles and stop at the given position.
Rotate Given Positions Enter the desired number (1-80) into the edit box
below Position to specify how many cuvette
positions the reaction disk should rotate.
Click this button and the reaction disk will rotate
the given positions.
NOTE:
Before operating the reaction disk, ensure the sample and reagent
probes and mixing bar are away from it. Otherwise, the moving disk
may bend the probes or bar.
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Button What it does
Rotate Given Circles to Enter the desired number into the edit box
Given Position below Circles to specify how many circles the
reagent disk should run. Enter the desired
number (1-50) into the edit box below Position
to specify at which position the reagent disk
should stop.
Click this button and the reagent disk will rotate
the given circles and stop at the given position.
Rotate Given Positions Enter the desired number (1-50) into the edit
box below Position to specify how many
positions the reagent disk should rotate.
Click this button and the reagent disk will rotate
the given positions.
NOTE:
Before operating the reagent disk, ensure the reagent probe is away
from it. Otherwise, the moving disk may bend the probes.
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Button What it does
Rotate Given Circles to Enter the desired number into the edit box
Given Position below Circles to specify how many circles the
sample disk should run. Enter the desired
number (1-60) into the edit box below Position
to specify at which position the sample disk
should stop.
Click this button and the sample disk will rotate
the given circles and stop at the given position.
Rotate Given Positions Enter the desired number (1-60) into the edit
box below Position to specify how many
positions the sample disk should rotate.
Click this button and the sample disk will rotate
the given positions.
NOTE:
Before operating the sample disk, ensure the sample probe is away
from it. Otherwise, the moving disk may bend the probe.
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Button What it does
Wash Sample Probe Select Inner Surface, Outer Surface or Both
Surfaces from the pull down list to the right of this
button and click it to wash the exterior or interior of
the sample probe.
Wash Reagent Probe Select Inner Surface, Outer Surface or Both
Surfaces from the pull down list to the right of this
button and click it to wash the exterior or interior of
the reagent probe.
Wash Mixing Bar Click it to wash the exterior of the mixing bar.
S. Syringe Aspirate Enter the desired number (3-45) into the edit box
below Volume(S. Syringe).
Click this button and the sample syringe aspirates
the given volume (μl).
S. Syringe Dispense Enter the desired number (3-45) into the edit box
below Volume(S. Syringe).
Click this button and the sample syringe dispenses
the given volume (μl).
Reset S. Syringe Click this button and reset the sample syringe.
R. Syringe Aspirate Enter the desired number (30-450) into the edit box
below Volume(R. Syringe).
Click this button and the reagent syringe aspirates
the given volume (μl).
R. Syringe Dispense Enter the desired number (30-450) into the edit box
below Volume(R. Syringe).
Click this button and the reagent syringe dispenses
the given volume (μl).
Reset R. Syringe Click this button and reset the reagent syringe.
NOTE:
When you have clicked the S. Syringe Dispense button, if there is no
enough liquid inside the sample syringe, the plunger will stop at the
home position.
When you have clicked the R. Syringe Dispense button, if there is no
enough liquid inside the reagent syringe, the plunger will stop at the
home position.
4-160
4.4.6.8 Cuv. Comp. tab
4-161
4.4.6.9 Lamp tab
NOTE:
If nothing is to be run for a while and you have no intention to exit the
control system, you can turn off the lamp to maximize its service life.
4-162
4.4.6.10 Autoloader tab
4-163
4.4.6.11 Others tab
4.4.7 Print
The Printing Setup screen is where you set the parameters regarding printing
reports.
To enter the Printing Setup screen, click System → Print, or press CTRL + O.
4-164
Figure 4-79 Printing Setup screen
At the Printing Setup screen, Figure 4-79, there are four tabs:
Patient Report – defines parameters regarding the format of the patient report.
Test Report – defines items to appear on the printed test report.
Others – defines printing order and printer.
Report Header – defines the report header.
4-165
As Figure 4-80 shows, the items listed in the Required field are required to appear
on the patient report; the items listed in the Optional field are selectable items and
you can select any interested items to print on the patient report.
4-166
As Figure 4-81 shows, the items listed in the Required field are required to appear
on the test report; the items listed in the Optional field are selectable items and you
can select any interested items to print on the report.
4-167
2 Select the desired sequence number from the pull down list above Set
Printing Order.
2 Click the Default Printer button to set the selected printer as the default
printer.
The system will automatically print reports of the sample runs whose
results are within or beyond reference range. A “!” symbol will be printed
next to the sample ID of abnormal sample runs.
2 Select the Flag Edited Results checkbox to flag the edited results on
patient report.
4-168
4.4.7.4 Report Header tab
NOTE:
The format of the printout may not be exactly the same as that
displayed in the print preview window.
4.4.8 Temperature
Click System→ Temperature or press CTRL + T and a dialog box will pop up, as
Figure 4-84 shows, to ask you whether you want to debug the temperature control
unit or check the temperature curve.
4-169
Figure 4-84 A dialog box to ask you whether to debug or to view curves
Click the Cancel button and another dialog box will pop up to ask you to enter
appropriate username and password, as Figure 4-85 shows.
CAUTION:
Only service engineers are authorized to debug the temperature
control unit.
Figure 4-85 A dialog box to ask you to enter username and password
As Figure 4-86 shows, you can see two tabs at the Temperature Control screen:
4-170
Preheating Temp. Curve tab - displays temperature curve of preheating the
reagents.
Reaction Temp. Curve tab - displays the temperature curve of the reaction disk.
For every temperature curve, its x-axis represents the time and y-axis the
temperature.
NOTE:
Click to check the previous curve;
To lock a curve
1 Click the Lock button to lock the currently displayed curve.
To unlock a curve
1 Click the Unlock button to unlock the currently locked curve.
4-171
4.4.9 Database
Click System → Database or press CTRL + L and a dialog box will pop up, as
Figure 4-87 shows, to ask you to enter the appropriate user name and password.
Figure 4-87 A dialog box to ask you enter the user name and password
Enter the user name and password of the administrator authority to enter the
Database Maintenance screen as Figure 4-88 shows.
NOTE:
You can only maintain the database when the analyzer is on standby.
This analyzer automatically backs up data. You only need to maintain
the database when the system alerts you that the database is
damaged.
Usually you do not need to delete the reaction curves. Deleting the
curves (only curves, not the results) only when you find insufficient
space left on the hard disk.
4-172
To repair and compress current database
1 When the analyzer warns you about database damage, click the Repair &
Compress button to repair and compress current database.
NOTE:
If the system has no built-in bar code scanner (optional), the sub menu
is gray and unavailable.
Click System→ Bar Code Scanner or press Ctrl+L and a dialog box shown as the
figure below will pop up.
Click the Cancel button and another dialog box shown as the figure below will pop
up.
4-173
Enter authorized user name and password to enter the Bar Code Scanner screen.
The screen displays the bar code symbols that can be read by the built-in scanner.
You can select the ones that you need.
NOTE:
To prevent from misreading, we recommend
you to select the check box.
3 Enter the bar code length of the selected symbology into the
corresponding edit box in the Symbol Length column. The length is
between 3 and 16.
4 Repeat from step 1 to step 3 until all the symbologies you need are set.
5 Click the Save button and a dialog box will pop up to remind you that the
setup is completed.
6 Click the OK button.
7 Click the button at the upper right corner of the Bar Code Scanner
screen to exit the screen.
4-174
4.4.11 ISE Unit
Click System→ ISE Unit or press Ctrl+D to enter the ISE screen.
Calibration
Setup
ISE Unit
4.4.11.1 Calibration
The Calibration tab displays the calibration results and limits of the ISE tests and
you can calibrate them.
NOTE:
An ISE calibration should be run in case of any of the following
accidents:
(1) More ISE tests are to be run after the system is powered on;
(2) It has been eight hours since the last ISE calibration is run after the
latest power-on;
(3) More ISE tests are to be run after the daily cleaning
procedure. But We recommend running an ISE
calibration after the daily cleaning procedure.
4-175
4.4.11.2 Setup
The Setup tab is where you can set parameters for electrodes and tubing, set
coefficients for results correction and view information of the reagent module.
4-176
Parameter What it does How to set
Total Total volume of the reagent -
Volume module.
Inventory(%) Ratio between the volume of -
remaining reagents and the total
volume.
Lot No. Lot No. of the reagent module. -
Expired Expired mode of the reagent -
Mode module.
2 Click the Save button. The system will correct the results of the tests you
have set according to the formula Y=aX+b (Y means new result and X
means original result).
NOTE:
The system will save the new results only.
4-177
Figure 4-92 ISE Unit tab
4-178
Button What it does
Save Received Click this button to save the instructions displayed in the
Received instruction window to a .txt file in the directory
where the executable file of the operating software locates.
Clear Click this button to clear the displayed in the upper two
windows.
ISE Reset If there is something wrong with the ISE unit and ISE tests
cannot proceed, click this button to reset the ISE unit.
4.5 Help
Help Version
Guide
4.5.1 Version
Click Help→ Version or press CTRL + S to enter the Software version screen.
4.5.2 Guide
Click Help→ Guide or press CTRL + F11 to view the on-line help document.
4-179
4-180
5 Maintenance
To ensure reliability, good performance and long service life of the system, regular
maintenance is required. Be sure to follow the instructions given below to maintain the
system. In case of problems beyond your ability or not covered in this chapter, be sure to
call our company or your local distributor in time.
WARNING:
Do not perform any maintenance procedures that are not described
in this chapter.
Do not touch the components other than the ones specified in this
chapter.
Performing unauthorized maintenance procedures can damage your
system, void any applicable warranty or service contract and even
cause personnel injuries.
After performing any maintenance actions or procedures, ensure
that the system runs normally.
For some maintenance actions or procedures, be sure to place the
POWER to OFF first.
Do not spill water or detergent on the mechanical or electrical
components of the system.
BIOHAZARD:
Wear gloves, goggles and protective clothing.
5.1 Preparation
The following things may facilitate your maintenance.
Tools
M1.5, M3 and/or M4 hex wrenches
Cross-headed screwdrivers (small, medium and large)
Syringe
A clean cup
Tweezers
Clean gauze
Clean cotton stick
Brush (to wash tanks)
Syringe (5-10ml)
Rubber gloves
5-1
Detergents
Acid: 0.1mol/l hydrochloric acid
Alkaline: CD80 wash solution
WARNING:
Poisonous gas will be produced if acid wash solution is mixed with
alkaline wash solution. Do not mix the acid wash solution with the
alkaline one.
CAUTION:
We have specified the following enhanced wash solutions:
Acid wash solution: 0.1mol/l hydrochloric acid;
Alkaline wash solution: CD80 wash solution.
Be sure to use the enhanced wash solution specified by our company.
Otherwise, proper result may not be obtained.
We recommend the acid and alkaline wash solutions be used
alternately. For instance, if the acid wash solution is used at current
startup, the alkaline one should be used at next startup.
Others
Ethanol
Disinfector
5-2
2 Open the middle door of the analyzing unit and you will see both of the
syringes, the sample syringe on the right and the reagent syringe on the
left.
Plunger
Guide Cap
During the washing process, check whether the flow from the interior of the sample probe is
continuous and in the direction of the probe; check the exterior of the sample probe to see
whether the flow is continuous and normal.
If the flow appears abnormal, wash the probe as instructed by 5.3.1 Washing Sample
Probe.
If the flow remains abnormal after washing, clean the probe as instructed by 5.6.1
Unclogging Sample Probe.
If the flow remains abnormal after cleaning, contact our Customer Service Department or the
distributor.
5-3
5.2.3 Checking/Washing Reagent Probe
At every startup, the system will automatically wash the interior and exterior of the reagent
probe with deionized water. At every shutdown, the system will automatically wash the
interior and exterior of the reagent probe with the acid and alkaline detergents.
During the washing process, check whether the flow from the interior of the reagent probe is
continuous and in the direction of the probe; check the exterior of the reagent probe to see
whether the flow is continuous and normal.
If the flow appears abnormal, wash the probe as instructed by 5.3.2 Washing Reagent
Probe.
If the flow remains abnormal after washing, clean the probe as instructed by 5.6.2
Unclogging Reagent Probe.
If the flow remains abnormal after cleaning, contact our Customer Service Department or the
distributor.
During the washing process, check whether the bar rotates normally. If not, contact our
Customer Service Department or the distributor.
WARNING:
Always wear gloves when checking the detergents.
1 Make sure the system is on standby status, and ensure no part of the
system will motion.
2 Remove the cover from the reagent disk.
3 Check how much detergent left in the bottle on position 45. If there is not
much left, add more detergent or install a new bottle of detergent.
4 Check how much detergent left in the bottle on position 47. If there is not
much left, add more detergent or install a new bottle of detergent.
5 Replace the cover.
Every wash consumes about 450µl detergent when the system uses detergent to clean the
probes and the mixing bar.
5-4
2 Open the lower door of the analyzing unit and you will find the deionized
water tank on the right.
Deionized
Waste Tank
Water Tank
Used-Cuvettes
Bucket
Extractable
Plate
3 Check the connections between the two deionized water connectors (green
and red) and their counterparts on the analyzer.
Pickup Tube
5-5
9 Push the extractable plate back in.
10 Close the lower door.
CAUTION:
Make sure the deionized water pickup tubes are neither blocked nor
bent.
NOTE:
If leaking remains, please contact our Customer Service Department or
the distributor.
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the following checks.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
Pin
Waste Tap
Waste Tube
5-6
6 Check the connection between the waste tube and the tank cap.
If no leaks, go directly to the next step.
If you see leaks, wipe them off with clean gauze and tighten the
connection and proceed to the next step.
7 Push the extractable plate back in.
8 Close the lower door.
CAUTION:
Ensure the waste tube is neither blocked nor bent. A blocked or bent
waste tube may lead to waste overflow that may damage the analyzing
unit.
NOTE:
If leaking remains, please contact our Customer Service Department or
the distributor.
CAUTION:
The deionized water to be used on the system must meet the CAP
Type II water requirements and the resistance rate must be no less
than 0.5MΩ·cm.
Unscrew (counter-clockwise) the tank cap and remove the cap together
with the pickup tube and the level sensor.
6 Add deionized water to the tank.
7 Screw (clockwise) the cap together with the pickup tube and the level
sensor back on to the tank until secure.
8 Push the extractable plate back in.
9 Close the lower door.
5-7
CAUTION:
Ensure the deionized water pickup tube is neither blocked nor bent.
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below checks.
Dispose of the wastewater in accordance with your local or national
guidelines for biohazard waste disposal and consult the manufacturer
or distributor of the reagents for details.
Unscrew (counter-clockwise) the tank cap and remove it together with the
waste tube and the level sensor from the tank.
5 Take out the tank and empty it.
6 Replace the tank back into the cabinet.
7 Screw (clockwise) the cap (together with the waste tube and the level
sensor) back onto the tank until secure.
8 Push the extractable plate back in.
9 Close the lower door.
CAUTION:
Ensure the waste tube is neither blocked nor bent. A blocked or bent
waste tube may lead to wastewater overflow that may damage the
analyzer.
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below checks.
Dispose of the used cuvettes in accordance with your local or national
guidelines for biohazard waste disposal.
5-8
1 Place the ANALYZING UNIT POWER to OFF.
2 Open the lower door of the analyzing unit and you will see the
used-cuvettes bucket in the middle.
3 Take out the bucket and empty it.
4 Replace the bucket back into the cabinet.
5 Close the lower door.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when washing the probe.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
5-9
3 Pull the sample probe arm to the highest point by hand. Rotate the probe
arm to a position above the sample compartment and convenient to
operate.
4
CAUTION:
The tweezers may scratch the probe. Exercise caution when
using it to wash the probe. Avoid direct contact between the
tweezers and the probe. Do not use excessive force when
washing the probe. Otherwise it may bend.
NOTE:
We recommend the acid and alkaline detergents be used
alternately for this purpose. For instance, if the acid
detergent was used for last cleaning, the alkaline detergent
would better be used for this time.
CAUTION:
After washing the probe, be sure to rotate the probe to a
position above the wash well.
5-10
7 Keep the sample disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the sample disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor.
To ensure the disk is secured, you may grab the handwheel and gently
pull it upward. If the disk does not loose, it means it is secured and you
can replace the cover; otherwise, re-install the disk.
8 Place the ANALYZING UNIT POWER to ON and the system will
automatically reset the sample probe and wash it with deionized water.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when washing the probe.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
5-11
3 Pull the reagent probe arm to the highest point by hand. Rotate the probe
arm to a position above the reagent compartment and convenient to
operate.
4
CAUTION:
The tweezers can scratch the probe. Exercise caution when
using it to wash the probe. Avoid direct contact between the
tweezers and the probe. Do not use excessive force when
washing the probe. Otherwise it may bend.
NOTE:
We recommend the acid and alkaline detergents be used
alternately for this purpose. For instance, if the acid
detergent was used for last cleaning, the alkaline detergent
would better be used for this time.
CAUTION:
After washing the probe, be sure to rotate the probe to a
position above the wash well.
5-12
7 Keep the reagent disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the reagent disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor.
To ensure the disk is secured, you may grab the handwheel and gently
pull it upward. If the disk does not loose, it means it is secured and you
can replace the cover; otherwise, re-install the disk.
8 Place the ANALYZING UNIT POWER to ON and the system will
automatically reset the reagent probe and wash it with deionized water.
BIOHAZARD:
Wear gloves, goggles and protective clothing when washing the probe.
Dispose of the used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
5-13
3
CAUTION:
The tweezers can scratch the bar. Exercise caution when
using the tweezers to wash the bar. Avoid direct contact
between the tweezers and the bar. Do not use excessive
force when washing the bar. Otherwise it may bend.
NOTE:
We recommend the acid and alkaline detergents be used
alternately for this purpose. For instance, if the acid
detergent was used for last cleaning, the alkaline detergent
would better be used for this time.
CAUTION:
After washing the bar, be sure to rotate the bar to a position
above the wash well.
CAUTION:
The mixing bar is precisely fabricated. Replace the scratched or bent
bar once finding it. Refer to 5.6.5 Replacing Mixing Bar for details. .
5-14
5.3.4 Washing Deionized Water Tank
CAUTION:
The deionized water to be used on the analyzer must meet the CAP
Type II water requirements and the resistance rate must be no less
than 0.5MΩ·cm.
CAUTION:
Ensure the deionized water pickup tube is neither blocked nor bent.
5-15
5.3.5 Washing Waste Tank
BIOHAZARD:
To prevent biohazard contamination, wear gloves, goggles and
protective clothing when washing the tank.
Exercise caution and do not spill the waste onto other people or things.
Dispose of the waste in accordance with your local or national
guidelines for biohazard waste disposal and consult the manufacturer
or distributor of the reagents for details.
Dispose of used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
Unscrew (counter-clockwise) the cap (together with the waste tube and the
level sensor).
5 Take out the waste tank.
6 Empty the waste tank.
7 Wash the tank interior with clean water. Soak the tank with disinfector if
necessary.
8 Wash the waste tube and the level sensor with clean water.
9 Wipe water off the tank exterior, waste tube and sensor cable with clean
gauze.
10 Place the deionized water tank back onto the extractable plate.
11 Screw (clockwise) the cap (together with the waste tube and level sensor)
back onto the tank until secure.
12 Push the extractable plate back in.
13 Close the lower door.
CAUTION:
Ensure the waste tube is neither blocked nor bent. A blocked or bent
waste tube will lead to waste overflow that may damage the analyzing
unit.
5-16
5.3.6 Cleaning Sample Disk/Compartment
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the
sample disk/compartment.
Dispose of used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
3 Wash the disk with clean water and wipe it dry with clean gauze.
4 Use clean gauze (water or disinfector-dipped gauze if necessary) to clean
the inside of the compartment.
5-17
5 If the bar code scanner(optional) is connected, use ethanol-dipped gauze
to clean the window of the bar code scanner.
6 Keep the sample disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the sample disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor. To ensure the disk is secured, you may grab the handwheel
and gently pull it upward. If the disk does not loose, it means it is secured
and you can replace the cover; otherwise, re-install the disk.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the
reagent disk/compartment.
Dispose of used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
3 Wash the disk with clean water and wipe it dry with clean gauze.
5-18
4 Use clean gauze (water or disinfector-dipped gauze if necessary) to clean
the inside of the compartment.
5 Keep the reagent disk handle in the vertical position. Align the central hole
of the handwheel to the rotor and lower the reagent disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk
to the rotor. To ensure the disk is secured, you may grab the handwheel
and gently pull it upward. If the disk does not loose, it means it is secured
and you can replace the cover; otherwise, re-install the disk.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the panel
of analyzing unit.
Dispose of used gauze in accordance with your local or national
guidelines for biohazard waste disposal.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
5-19
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the wash
well.
Dispose of used cotton sticks in accordance with your local or national
guidelines for biohazard waste disposal.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the wash
well.
Dispose of used cotton sticks in accordance with your local or national
guidelines for biohazard waste disposal.
5-20
3 Clean the inside of and the place around the wash well with cotton sticks.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the wash
well.
Dispose of used cotton sticks in accordance with your local or national
guidelines for biohazard waste disposal.
5-21
5.4.4 Cleaning Sample Probe Rotor
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the rotor.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the rotor.
5-22
2 Wipe the rotor with clean gauze.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when cleaning the rotor.
5-23
5.5 Maintenance Every Six Months
2 Inject water into the new filter assembly through the big adapter by using
the syringe. When water wells up from the small adapter, the injection is
completed. Purpose: increase the weight of the filter assembly to make it
sink to the bottom of the water tank.
5-24
3 Connect the new filter assembly to the tubes of the cap assembly.
5-25
5.6.1.1 Removing Sample Probe
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when removing the
probe.
3 Pull the sample probe arm to its highest point. Rotate the probe to a
position above the sample disk and convenient to operate.
5-26
4 Grab the lower part of the arm cover with two hands and pull them slightly
outwards and remove the cover upward from the arm base.
5 Hold the probe’s fluid connector of probe with one hand and the tubing
connector with the other. Rotate tubing connector counter-clockwise until it
disconnects from the probe. Remove the tubing from the probe.
NOTE:
When disconnecting the tubing connector, please exercise
caution to avoid losing the white sealing ring and prevent
water from dropping on the circuit board.
5-27
6 Press the circuit board with one hand and disconnect the probe’s circuit
connector from the board with the other hand.
If you clean the sample probe with an unclogging device, skip to section
5.6.1.2Unclogging Sample Probe.
Circuit board
Connector
CAUTION:
The probe arm is delicate. Exercise caution when
disconnecting the connector. Excessive force may damage
the connector and/or the circuit board.
7 Use a screwdriver to remove the retaining screw and take out the spring.
5-28
8
WARNING:
Save the removed probe at a safe place where it will neither
endanger people working around the area nor be damaged.
NOTE:
Exercise caution when pulling the probe away from the arm
so that the probe tip will not contact or even damage the
probe arm.
Slowly pull the probe away from the probe arm. Exercise caution so that
the gasket inside the probe will not drop out and if it does drop out, save it
at a clean place for later installation.
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.3 Replacing Sample Probe for details.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when unclogging the
probe.
Dispose of the used needle in accordance with your local or national
guidelines for biohazard waste disposal.
5-29
3 Use a single-use syringe to aspirate 3ml CD80 wash solution, remove the
needle and connect the syringe to the other end of the unclogging device.
Push the syringe plunger slowly until there comes liquid out of the sample
probe tip.
Syringe
Unclogging device
4 If no liquid comes out of the sample probe tip, insert a needle into the
sample probe tip and push the syringe plunger.
5 Leave the sample probe soaked with wash solution for about 10 minutes.
Push and pull the syringe plunger for several times until liquid comes out
of the probe tip evenly.
6 Use the syringe to aspirate deionized water and rinse the sample probe for
at least 3 times.
7 Remove the unclogging device and the syringe, and then connect the
tubing connector.
8 Remove the container.
CAUTION:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.3 Replacing Sample Probe for details.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when installing the probe.
5-30
1 Place the ANALYZING UNIT POWER to OFF.
2 If the sample probe is removed, insert the probe back into the arm.
3 Replace the spring and screw the retaining screw back onto the probe.
4 Pinch the probe by the part near the probe arm. Gently push the probe
upward and then release the probe to see if it can move freely. If so, proceed
to the next step; if not, check for errors and try again after removing the
errors.
5 Connect the probe’s circuit connector back to the circuit board.
6 Ensure the gasket is inside the probe.
7 Screw the probe’s fluid connector back to the tubing connector.
CAUTION:
Exercise caution when connecting the probe. Excessive
force may bend the probe.
8 Place the ANALYZING UNIT POWER to ON while ensuring that the sample
probe is not attaching any conducting .object, such as hands.
9 Calibrate the sample probe manually. Check if indicator D2 (yellow) is
lightened within 2 seconds when the ANALYZING UNIT POWER to ON.
Press the switch S2 on the level detection board and then release it, then
check if indicator D2 is first extinguished and then lightened. If it is, that
means the calibration succeeds.
Exercise caution to prevent the sample probe from attaching any conducting
object during the calibration.
10 Add deionized water to a clean cup. Immerse the probe tip into the water by
5-31
2-3mm and indicator D5 on the circuit board should be lighted. Take the
probe tip out of water, and the indicator should go out. If the test succeeds,
proceed to the next step; if not, please contact our Customer Service
Department or the distributor.
11 Check the marks inside the probe arm cover to see the orientation of the
cover. Install the cover back to the probe arm.
CAUTION:
The marks inside the probe arm cover are shown in the figure
below.
12 Pinch the probe by the part near the probe arm. Gently push the probe
upward and then release the probe to see if it can move freely. If so, proceed
to the next step; if not, the cover is not properly installed. Remove the cover
and re-install it and try this step again.
13 Pull the sample probe arm to its highest point. Rotate the probe to a position
above the wash well.
CAUTION:
After installing the sample probe, be sure to rotate the probe
to a position above the wash well.
5-32
14 Keep the sample disk handle in the vertical position. Align the central hole of
the handwheel to the rotor and lower the sample disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk to
the rotor. To ensure the disk is secured, you may grab the handwheel and
gently pull it upward. If the disk does not loose, it means it is secured and
you can replace the cover; otherwise, re-install the disk.
15 Place the ANALYZING UNIT POWER to ON. The system will automatically
reset the probe and wash it with deionized water.
CAUTION:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when removing the
probe.
5-33
3 Pull the reagent probe arm to its highest point. Rotate the probe to a
position above the reagent disk and convenient to operate.
4 Grab the lower part of the arm cover with two hands and pull them slightly
outwards and remove the cover upward from the arm base.
5-34
5 Hold the probe’s fluid connector with one hand and the tubing connector
with the other. Rotate tubing connector counter-clockwise until it
disconnects from the probe. Remove the tubing from the probe.
If you clean the reagent probe with an unclogging device, skip to section
5.6.2.2Unclogging Reagent Probe.
NOTE:
When disconnecting the tubing connector, please exercise
caution to avoid losing the white sealing ring and prevent
water from dropping on the circuit board.
6 Press the circuit board with one hand and disconnect the probe’s circuit
connector from the board with the other hand.
Circuit board
Connector
CAUTION:
The probe arm is delicate. Exercise caution when
disconnecting the connector. Excessive force may damage
the connector and/or the circuit board.
5-35
7 Use a screwdriver to remove the retaining screw and take out the spring.
8
WARNING:
Save the removed probe at a safe place where it will neither
endanger people working around the area nor be damaged.
NOTE:
Exercise caution when pulling the probe away from the arm
so that the probe tip will not contact or even damage the
probe arm.
Slowly pull the probe away from the probe arm. Exercise caution so that
the gasket inside the probe will not drop out and if it does drop out, save it
at a clean place for later installation.
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.4 Replacing Reagent Probe for details.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when unclogging the
probe.
Dispose of the used needle in accordance with your local or national
guidelines for biohazard waste disposal.
5-36
3 Use a single-use syringe to aspirate 3ml CD80 wash solution, remove the
needle and connect the syringe to the other end of the unclogging device.
Push the syringe plunger slowly until there comes liquid out of the reagent
probe tip.
4 If no liquid comes out of the reagent probe tip, insert a needle into the
reagent probe tip and push the syringe plunger.
5 Leave the reagent probe soaked with wash solution for about 10 minutes.
Push and pull the syringe plunger for several times until liquid comes out
of the probe tip evenly.
6 Use the syringe to aspirate deionized water and rinse the reagent probe
for at least 3 times.
7 Remove the unclogging device and the syringe, and then connect the
tubing connector.
8 Remove the container.
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.4 Replacing Reagent Probe for details.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when installing the probe.
5-37
7
CAUTION:
You must shape the tubing inside the reagent probe arm into
a ring.
10 Add deionized water to a clean cup. Immerse the probe tip into the water by
2-3mm and indicator D5 on the circuit board will be lighted. Take the probe
tip out of water, and the indicator will go out.
If the test succeeds, proceed to the next step.
If not, please contact our Customer Service Department or the distributor.
5-38
11 Check the marks inside the probe arm cover to see the orientation of the
cover. Install the cover back to the probe arm.
CAUTION:
The marks inside the probe arm cover are shown in the figure
below.
12 Pinch the probe by the part near the probe arm. Gently push the probe
upward and then release the probe to see if it can move freely.
If so, proceed to the next step.
If not, the cover is not properly installed. Remove the cover and re-install it
and try this step again.
13 Pull the reagent probe arm to its highest point. Rotate the probe to a position
above the wash well.
CAUTION:
After installing the reagent probe, be sure to rotate the probe
to a position above the wash well.
14 Keep the reagent disk handle in the vertical position. Align the central hole of
the handwheel to the rotor and lower the reagent disk all the way down.
Rotate the disk a bit as necessary during the lowering process. When the
disk is in place, shift the handle back to horizontal position to lock the disk to
the rotor. To ensure the disk is secured, you may grab the handwheel and
gently pull it upward. If the disk does not loose, it means it is secured and
you can replace the cover; otherwise, re-install the disk.
15 Place the ANALYZING UNIT POWER to ON. The system will automatically
reset the probe and wash it with deionized water.
5-39
NOTE:
The probe tip is precisely fabricated. A bent or damaged probe will lead
to unreliable test results and should be replaced immediately upon
seeing. Refer to 5.6.4 Replacing Reagent Probe for details.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
BIOHAZARD:
Wear gloves, goggles and protective clothing when replacing the
probe.
CAUTION:
Please use consumables recommended by our company. Other
consumables may degrade the system performance.
BIOHAZARD:
Dispose of the bent or damaged sample probe in accordance
with your local or national guidelines for biohazard waste
disposal.
CAUTION:
After installing the sample probe, be sure to rotate the probe
to a position above the wash well before installing the
sample disk.
WARNING:
The probe tip is sharp and can cause puncture wounds. To prevent
injury to your hands or arms, exercise caution when working around
the probe.
5-40
BIOHAZARD:
Wear gloves, goggles and protective clothing when replacing the
probe.
CAUTION:
Please use consumables recommended by our company. Other
consumables may degrade the system performance.
BIOHAZARD:
Dispose of the bent or damaged reagent probe in
accordance with your local or national guidelines for
biohazard waste disposal.
CAUTION:
You must shape the tubing inside the reagent probe arm into
a ring.
WARNING:
The sample probe tip is sharp and can cause puncture wounds. To
prevent injury to your hands or arms, exercise caution when working
around the probe.
When replacing the bar, pinch the bar only by the knurled part and do
not touch the other part of the bar. Protect the flat par of the mixing bar
from scratches.
5-41
BIOHAZARD:
Wear gloves, goggles and protective clothing when replacing the
mixing bar.
Dispose of the damaged mixing bar in accordance with your local or
national guidelines for biohazard waste disposal.
CAUTION:
Please use consumables recommended by our company. Other
consumables may degrade the system performance.
5-42
4 Pinch the bar by the knurled part with one hand and unscrew
(counter-clockwise) the retaining nut with the other until the mixing bar
looses. Pull the bar downward to remove it and remove the nut.
CAUTION:
When trying to pull out the bar, concentrate your force in the
direction of the axis on the bar arm. Biased force may
damage the bar and/or the axis.
5 Align the mixing bar to the bigger hole of the retaining nut and gently
screw it into the nut until the end of the bar is in line with the smaller hole
of the nut.
6 Pinch the mixing bar by the knurled part and align the hole of the nut to the
axis of the mixing bar and push the nut onto the bar until it reaches the
end of the bar. Tighten the nut (screw clock-wise) with the other hand.
CAUTION:
When trying to push the bar into the arm, concentrate your
force in the direction of the axis on the bar arm. Biased force
may damage the bar and/or the axis.
Ensure the bar is all the way pushed to the end.
7 After replacing the bar, visually check whether the bar is vertical to the bar
arm.
If yes, proceed to the next step.
If not, repeat step 5 to remove the bar and re-install it.
5-43
8 Pull the bar arm to its highest point and rotate it back to a position above
its wash well.
CAUTION:
After installing the mixing bar, be sure to rotate the mixing
bar to a position above its wash well before turning on the
analyzing unit.
9 Place the ANALYZING UNIT POWER to ON. The system will automatically
reset the bar and wash it with deionized water.
10 Follow the steps given below to do the position checks:
Enter the System Maintenance screen and select the Mixing Bar tab as
instructed by 4.4.6.3 Mixing Bar tab.
Click Into Wash Well and observe whether the mixing bar is aligned to the
center of the wash well. If not, please contact our Customer Service
Department or the distributor.
Set the Time to 100 and click Mix. The bar should start to rotate after
enters the reaction cuvette. Observe whether the rotation is normal and
pay attention to abnormal sound. If the rotation is not normal or the
abnormal noise is heart, please contact our Customer Service Department
or the distributor.
5-44
The old one has been used for over 100,000 tests; or
The old one is apparently damaged.
CAUTION:
Please use consumables recommended by our company. Other
consumables may degrade the system performance.
Exercise caution when installing the syringe. Excessive force may
crack the syringe.
Follow the procedure given below to replace the plunger assembly of sample or reagent
syringe.
3 Prepare a new plunger assembly (shown in the figure below) and soak the
plunger tip in deionized water to eliminate bubbles.
5-45
6
CAUTION:
There may be residual water in the syringe. Exercise caution
when removing it. Do not drop water onto the analyzing unit.
Grab the T-piece with one hand and the syringe connector with the other
hand and unscrew (counter-clockwise) the syringe. Exercise caution so that
the gasket on the syringe does not drop out and if it does, store it in a clean
place for later installation. Replace the gasket if it has been disassembled
for 2 to 3 times. Otherwise leakage may occur or sampling precision be
affected.
7
CAUTION:
There may be residual water in the syringe. Exercise caution
when pulling the plunger assembly out. Do not drop water onto
the analyzing unit.
The plunger rod of the sample syringe is slender. Exercise
caution when working on it. Excessive force may bend it.
Unscrew (counter-clockwise) the plunger guide cap and pinch the plunger
button to gently pull the plunger assembly from the syringe.
8
CAUTION:
The plunger rod of the sample syringe is slender. Exercise
caution when working on it. Excessive force may bend it.
Pinch the new plunger assembly by the plunger button and carefully insert
the plunger tip into the syringe and push it all the way to the end. Screw
(clockwise) the plunger guide cap until secure.
9 Immerse the syringe connector into deionized water. Pinch the plunger
button, pull it to aspirate half syringe of deionized water and then push it to
expel the deionized water and the air from the syringe.
10 Grab the T-piece with one hand and the syringe connector with the other
hand. Screw (clockwise) the syringe into the T-piece until secure.
11 Place the syringe on the holder.
12 Install the space bars and four upper retaining screws. Note that do not
tighten the screws now.
13 Align the plunger button to the lower retaining screw of the plunger and
screw (clockwise) the screw until secure.
5-46
14 Pinch the plunger guide cap to adjust the syringe. Our company
recommends the upper edge of the space bar reach the fourth line (the 11μl
line of the sample reagent, or the 75μl line of the reagent syringe) of the
scale on the syringe.
15 Tighten the two upper retaining screws.
16 Place the ANALYZING UNIT POWER back to ON.
17 Enter the System Maintenance screen and set the Volume (SS. Syringe)
or Volume (R. Syringe) to the maximum value(45 for the sample syringe
and 450 for the reagent syringe ). Click S. Syringe Aspirate or R. Syringe
Aspirate and the syringe should start aspirating. After the syringe finishes
the motion, click S. Syringe Dispense or R. Syringe Dispense and the
syringe should start expelling. You may repeat this action several times.
Refer to 4.4.6.7 Fluid Path tab for details. Pay attention to bubbles during
the aspiration/dispensing process.
Go to the next step if no bubble is found.
If there are bubbles observed during the process, they may be caused by
the air leak between the syringe and the T-piece. Uninstall the syringe and
re-install it. If the bubbles are found again, please contact our Customer
Service Department or the distributor.
18 Close the middle door.
BIOHAZARD
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the maintenance.
Dispose of the waste in accordance with your local or national
guidelines for biohazard waste disposal.
CAUTION:
Be sure not to push the plunger to the end tip; otherwise the
syringe may be damaged.
5-47
6 Place the syringe on the holder. Install the space bars and tighten the
upper retaining screws.
NOTE:
The upper edge of the upper space bar must reach the 7th scale
on the syringe.
When fixing the retaining screws, be sure to tighten them
alternately with equilibrium force.
CAUTION:
Please use consumables recommended by our company. Other
consumables may degrade the system performance.
NOTE:
Do not touch either the light entrance of the lamp housing or the lens in
front of the lamp. In case the entrance is dirty, clean it with
ethanol-soaked defatted cotton.
1 Place the POWER to OFF. Wait at least 5 minutes for the lamp and its housing to
cool down.
WARNING:
After working for a while, the lamp and its housing are
usually hot enough to burn you. Do not proceed with this
procedure until they have cooled down.
5-48
2 Loosen the retaining screw on the lamp replacement door with hands or a
cross-head screwdriver, and then remove the door.
5-49
3 Unscrew the retaining nut and remove the cables.
Cable
connectors
Lamp
screw
5-50
5 Grab the lamp by the seat and pull it out.
6 Install the new lamp in the reversed steps. Restore the lamp replacement door.
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below maintenance.
CAUTION:
Use the consumables recommended by us. Other consumables may
degrade system performance.
NOTE:
The maintenance is necessary to be performed when the ISE unit
(optional) is connected.
If you run no more than 100 samples requested for the ISE tests a day, replace the
electrodes according to the following recommended schedule:
If you run more than 100 samples requested for the ISE tests a day, replace the electrodes
according to the following recommended schedule:
5-51
1 Place the POWER to OFF.
2 Open the ISE unit door.
3 Unscrew the screw of the ISE module manually.
4 Take the electrode(s) out from the housing by pressing down the
compression plate(s).
NOTE:
Because the electrodes must be installed sequentially, you
have to take out the electrode to be replaced and those (or
that) over it from above to below. For example, there is no
other electrode over the spacer, so you just need to take it
out; There are four electrodes over the reference electrode,
so you have to take out all the five electrodes from above to
below.
5 Install the new electrode. Refer to the 2.4.1 Installing Electrodes for
details.
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below maintenance.
Dispose of the waste in accordance with your local or national
guidelines for biohazard waste disposal.
CAUTION:
Use the consumables recommended by us. Other consumables may
degrade system performance.
NOTE:
The maintenance is necessary to be performed when the ISE unit
(optional) is connected.
5-52
5.6.11 ISE Unit Storage (optional)
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below maintenance.
Dispose of the waste in accordance with your local or national
guidelines for biohazard waste disposal.
CAUTION:
Use the consumables recommended by us. Other consumables may
degrade system performance.
NOTE:
The maintenance is necessary to be performed when the ISE unit
(optional) is connected.
The ISE unit (optional) should be on power all the time. In some cases
that the POWER will be shut down for a long time more than half an
hour, the following steps should be performed.
5-53
17 Discard the reagent module.
BIOHAZARD:
To prevent biohazard contamination, always wear gloves, goggles and
protective clothing when doing the below maintenance.
CAUTION:
Use the consumables recommended by us. Other consumables may
degrade system performance.
After completing the following steps, ensure to calibrate the ISE tests
before testing.
NOTE:
Before reusing the ISE unit (optional) that has been stored, you must
complete the following steps.
5-54
Daily Maintenance Month:——— Year:———
Maintenance Record
Daily Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Checking Sample Syringe
2 Checking Reagent Syringe
3 Checking/Washing Sample Probe
4 Checking/Washing Reagent Probe
5 Checking/Washing Mixing Bar
6 Checking Detergents
7 Checking Connection of Deionized Water
8 Checking Connection of Wastewater
9 Checking Remaining Deionized Water
10 Emptying Waste Tank
11 Emptying Used-Cuvettes Bucket
12 Cleaning ISE Unit (optional)
13 Pump Calibration (optional)
5-55
Monthly Maintenance Month:——— Year:———
Maintenance Record
Monthly Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Cleaning Wash Well of Sample Probe
2 Cleaning Wash Well of Reagent Probe
3 Cleaning Wash Well of Mixing Bar
4 Cleaning Sample Probe Rotor
5 Cleaning Reagent Probe Rotor
6 Cleaning Mixing Bar Rotor
5-56
6 Troubleshooting
This chapter presents all error messages and recommended measures, which
should be taken in time once any error occurs.
If the recommended measures fail to solve the problems, contact our company or
your local distributor.
When an error occurs, its corresponding error message will be displayed on the
lower left side of the screen, as Figure 6-1 shows.
The log will record the time, level, code and message of every error (except for the
level-11 error) to facilitate you to troubleshoot the analyzer. Refer to 4.4.5 Log for
details about the log.
Figure 6-1 Error messages are displayed on the lower left side of the screen
6-1
Severity: Warning
Level Definition Actions taken by the analyzer
0 Negligible errors The analyzer will alert the operator without
further treatment in most circumstances
except that sometimes it will invalidate the test
and even pause.
1 Errors to be flagged The analyzer will flag the affected analysis so
that the operator knows something went
wrong during the analysis.
2 Errors to invalidate an The analyzer will invalidate the abnormal
analysis analysis and rerun the test.
20 Errors caused by The analyzer will ignore the related analyses
unavailable samples and proceed to other ones. When other
analyses are finished, the analyzer will pause
so that the operator can load the missing
samples to the sample disk.
Seeing this message, you can also press the
6-2
Level Definition Actions taken by the analyzer
5 Errors caused by the The analyzer will pause dispensing the
reagent disk reagents. All the analyses whose reagents
assembly and the (both the first and second reagents) have
reagent dispenser already been dispensed will be analyzed as
programmed. The other analyses will be
invalidated. When all the analyses are
finished, the analyzer will pause.
6 Errors caused by The analyzer will use all the remaining
cuvette loader only cuvettes and finish all the analyses on the
(reaction disk not reaction disk. When all the analyses are
affected) finished, the analyzer will pause.
7 Errors affecting the The analyzer will put all the sample and
sample disk and reagent dispensing on hold. The analyses
reagent disk only whose samples or reagents have been
(reaction disk not dispensed will be conducted as programmed
affected) and the other analyses will be invalidated.
When the analyses are finished, the analyzer
will pause.
13 Errors caused by The analyzer will pause dispensing R1 right
unavailable deionized now. All the analyses whose R1 has already
water or full waste- been dispensed will be analyzed as
tank programmed. When the analyses whose R1
has already been dispensed have finished,
the analyzer will pause so that operator can
add deionized water or empty the waste tank.
6-3
Level Definition Actions taken by the analyzer
12 / Running ISE tests is prohibited.
NOTE:
All errors except for those of level 11 will be recorded in the log. When
a level-11 error occurs, the operating system will display the error
message and exit the operating software after the error is confirmed by
the operator.
WARNING:
When troubleshooting the analyzer, first find out whether it is
necessary to switch off the POWER or ANALYZING UNIT POWER.
Wear gloves, goggles and lab coat if necessary.
6-4
Error code Error Message Level Corrective Measure
100000001 Parity error. 9 Contact our Customer Service Department or your local distributor.
100000002 Instruction too long. 9 Contact our Customer Service Department or your local distributor.
100000003 Incomplete instruction. 9 Contact our Customer Service Department or your local distributor.
100000004 Check sum error. 9 Contact our Customer Service Department or your local distributor.
100000005 Downloading parameter. Can't respond to other 9 Contact our Customer Service Department or your local distributor.
instructions.
100000006 Data at byte 00-0x7F exceed 0x7F. 9 Contact our Customer Service Department or your local distributor.
100960100 Wrong command. Illegal frame type. 9 Contact our Customer Service Department or your local distributor.
100960101 Wrong command. No this unit's command. 9 Contact our Customer Service Department or your local distributor.
100960102 Wrong command. Illegal command identity. 9 Contact our Customer Service Department or your local distributor.
100960103 Wrong command. Parameter significant bits wrong 9 Contact our Customer Service Department or your local distributor.
100960104 Wrong command. Instruction length wrong. 9 Contact our Customer Service Department or your local distributor.
100960105 Wrong command. Sample position not within 1-60 9 Contact our Customer Service Department or your local distributor.
100960106 Wrong command. Reagent position not within 1-50 9 Contact our Customer Service Department or your local distributor.
100960107 Wrong command. Other parameter error. 9 Contact our Customer Service Department or your local distributor.
100960200 MUI self-test error. 10 Contact our Customer Service Department or your local distributor.
100960300 MUI handshaking with sub-unit. Can't respond to other 9 Contact our Customer Service Department or your local distributor.
instructions.
100960500 MUI calling sub-unit to reset and self-test. Can't 9 Contact our Customer Service Department or your local distributor.
respond to other instructions.
100960900 MUI work status not supporting this command. 9 Contact our Customer Service Department or your local distributor.
Self-test.
100960901 MUI work status not supporting this command. Failed. 9 Contact our Customer Service Department or your local distributor.
100960902 MUI work status not supporting this command. 9 Contact our Customer Service Department or your local distributor.
Handshake.
6-5
Error code Error Message Level Corrective Measure
100960903 MUI work status not supporting this command. Reset. 9 Contact our Customer Service Department or your local distributor.
100960904 MUI work status not supporting this command. 9 Contact our Customer Service Department or your local distributor.
Shutdown.
100960905 MUI work status not supporting this command. Free. 9 Contact our Customer Service Department or your local distributor.
100960906 MUI work status not supporting this command. 9 Contact our Customer Service Department or your local distributor.
Mechanical reset.
100961000 MUI busy. Can't respond to current instruction. 9 Contact our Customer Service Department or your local distributor.
100961100 Disassemble instruction wrong. 9 Contact our Customer Service Department or your local distributor.
100961200 Attempted undefined system operation. 9 Contact our Customer Service Department or your local distributor.
100961400 Attempted undefined inquiry. 0 Contact our Customer Service Department or your local distributor.
100961500 Wrong parameter for inquiry. 0 Contact our Customer Service Department or your local distributor.
100961600 Attempted to configure undefined parameter. 0 Contact our Customer Service Department or your local distributor.
100961800 Attempted to configure undefined procedure. 0 Contact our Customer Service Department or your local distributor.
100961900 Wrong parameter for procedure configuration. 0 Contact our Customer Service Department or your local distributor.
100962000 E2PROM R/W wrong. Read error. 10 Contact our Customer Service Department or your local distributor.
100962001 E2PROM R/W wrong. Write error. 10 Contact our Customer Service Department or your local distributor.
100962002 E2PROM R/W wrong. Check sum error. 10 Contact our Customer Service Department or your local distributor.
100962003 E2PROM R/W wrong. Download error. 10 Contact our Customer Service Department or your local distributor.
100969000 Execution result not received within specified time. 9 Contact our Customer Service Department or your local distributor.
100969100 Command response wrong or no response 9 Contact our Customer Service Department or your local distributor.
100969200 Send Command error. 9 Contact our Customer Service Department or your local distributor.
101280100 Wrong command. Illegal frame type. 31 Contact our Customer Service Department or your local distributor.
101280101 Wrong command. Not this unit's instruction. 31 Contact our Customer Service Department or your local distributor.
101280102 Wrong command. Illegal command identity. 31 Contact our Customer Service Department or your local distributor.
6-6
Error code Error Message Level Corrective Measure
101280103 Wrong command. Instruction length wrong. 31 Contact our Customer Service Department or your local distributor.
101280104 Wrong command. Parameter significant bits wrong 31 Contact our Customer Service Department or your local distributor.
101280105 Wrong command. Other parameter wrong. 31 Contact our Customer Service Department or your local distributor.
101280200 Control unit self-test wrong 10 Contact our Customer Service Department or your local distributor.
101280300 Mechanical device reset wrong. 2 Contact our Customer Service Department or your local distributor.
101280400 Control unit not supporting this command. Self-test. 2 Contact our Customer Service Department or your local distributor.
101280401 Control unit not supporting this command. Malfunction. 4 Contact our Customer Service Department or your local distributor.
101280402 Control unit not supporting this command. Wait for 2 Contact our Customer Service Department or your local distributor.
handshake.
101280403 Control unit not supporting this command. Shutdown. 2 Contact our Customer Service Department or your local distributor.
101280404 Control unit not supporting this command. Processing 2 Contact our Customer Service Department or your local distributor.
command.
101280405 Control unit not supporting this command. Free. 2 Contact our Customer Service Department or your local distributor.
101280406 Control unit not supporting this command. Mechanical 2 Contact our Customer Service Department or your local distributor.
reset.
101280500 Control unit busy. Can't respond to current instruction. 2 Contact our Customer Service Department or your local distributor.
101280600 Attempted to configure un-defined speed. 2 Contact our Customer Service Department or your local distributor.
101280700 Speed configuration parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101280800 Attempted to configure undefined parameter. 0 Contact our Customer Service Department or your local distributor.
101280900 Parameter value beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101281000 Attempted undefined inquiry. 0 Contact our Customer Service Department or your local distributor.
101281100 Inquiry parameter beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101281200 Attempted undefined system instruction. 0 Contact our Customer Service Department or your local distributor.
6-7
Error code Error Message Level Corrective Measure
101281300 System instruction parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101281400 Attempted to commission undefined position. 0 Contact our Customer Service Department or your local distributor.
101281500 Commissioning parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101281600 System not commissioned or confirmation not 0 Contact our Customer Service Department or your local distributor.
consistent with instruction.
101281701 Tubing control failed. Rinse surface not detected during 9 Turn off the analyzing unit and then
power-on.
(1) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(2) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(3) Check the deionized water tank as instructed by 5.2.8 Checking
Remaining Deionized Water.
If the error remains, contact our Customer Service Department or your
local distributor.
101281800 Sample disk rotation failed. Can't reach initial point. 4 Ensure the sample disk rotates well as instructed by 4.4.6.6 S. Disk tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101281801 Sample disk rotation failed. Can't leave initial point. 4 Ensure the sample disk rotates well as instructed by 4.4.6.6 S. Disk tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101281802 Sample disk rotation failed. Can't detect weight disk 4 Ensure the sample disk rotates well as instructed by 4.4.6.6 S. Disk tab.
signal.
If the error remains, contact our Customer Service Department or your
local distributor.
6-8
Error code Error Message Level Corrective Measure
101281803 Sample disk rotation failed. Sample probe left in 4 Turn off the analyzing unit and check if the sample tubes are placed too
Sample disk. high on the sample disk.
If the error remains, contact our Customer Service Department or your
local distributor.
101281804 Sample disk rotation failed. Needle not at top point 4 Other errors have higher priority.
during rotation.
If the error remains, contact our Customer Service Department or your
local distributor.
101281902 Syringe A/D error. Can't reach initial point. 4 Check the sample syringe as instructed by 4.4.6.7 Fluid Path tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101281903 Syringe A/D error. Can't leave initial point. 4 Check the sample syringe as instructed by 4.4.6.7 Fluid Path tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101282000 Sample probe rotation error. Can't reach initial point. 4 (1) Turn off the analyzing unit and clean the sample disk rotor.
(2) Turn on the analyzing unit and check the sample probe as instructed
by 4.4.6.1 S. Probe tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101282001 Sample probe rotation error. Not at v-position for 4 (1) Turn off the analyzing unit and clean the sample disk rotor.
rotation.
(2) Turn on the analyzing unit and check the sample probe as instructed
by 4.4.6.1 S. Probe tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101282002 Sample probe v-move wrong. Can't reach initial 4 (1) Turn off the analyzing unit. Clean the sample disk rotor.
(Sample disk/wash) point.
(2) Turn on the analyzing unit and check the sample probe as instructed
by 4.4.6.1 S. Probe tab.
If the error remains, contact our Customer Service Department or your
local distributor.
6-9
Error code Error Message Level Corrective Measure
101282100 Sample probe v-moved wrong. Can't leave initial 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
(Sample disk/wash) point.
If the error remains, contact our Customer Service Department or your
local distributor.
101282101 Sample probe v-moved wrong. Can't leave initial 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
(Sample disk/wash) point.
If the error remains, contact our Customer Service Department or your
local distributor.
101282102 Sample probe v-move wrong. Not at initial point 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
(Sample disk/wash) for d-move start.
If the error remains, contact our Customer Service Department or your
local distributor.
101282107 Sample probe v-move wrong. Collision. 31 Turn off the analyzing unit and clear the obstacles from the path of the
vertical movement of the sample probe.
101282108 Sample probe v-move wrong. Collide with transducer 9 Turn off the analyzing unit and pinch the sample probe and push it upward
holder. to check whether the spring can move freely.
If the error remains, contact our Customer Service Department or your
local distributor.
101282110 Sample probe v-move wrong. Current position prohibits 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
v-move (Sample disk/wash).
If the error remains, contact our Customer Service Department or your
local distributor.
101282200 Attempted undefined simple operation. 0 Other errors have higher priority.
If the error remains, contact our Customer Service Department or your
local distributor.
101282300 Wrong cuvette position parameter in command. 2 Other errors have higher priority.
If the error remains, contact our Customer Service Department or your
local distributor.
6-10
Error code Error Message Level Corrective Measure
101282400 Illegal surface detection. 31 Turn off the analyzing unit.
(1) Check whether the sample tubes are placed too high on the sample
disk.
(2) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the sample probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.3 Replacing Sample Probe if
necessary.
(5) Clean the sample probe as instructed by 5.3.1 Washing Sample
Probe.
If this error occurs frequently, contact our company or your local distributor.
101282600 Syringe not initialized. 4 Contact our Customer Service Department or your local distributor.
101289000 No execution result received within specified time. 0 Contact our Customer Service Department or your local distributor.
101289100 Command response wrong or no response. 0 Contact our Customer Service Department or your local distributor.
101289200 Sending analyzed instructions failed. 9 Contact our Customer Service Department or your local distributor.
101440100 Wrong command. Illegal frame type. 31 Contact our Customer Service Department or your local distributor.
101440101 Wrong command. Not this unit's instruction. 31 Contact our Customer Service Department or your local distributor.
101440102 Wrong command. Illegal instruction identity. 31 Contact our Customer Service Department or your local distributor.
101440103 Wrong command. Instruction length wrong. 31 Contact our Customer Service Department or your local distributor.
101440104 Wrong command. Parameter significant bits wrong. 31 Contact our Customer Service Department or your local distributor.
101440105 Wrong command. Other parameter wrong. 31 Contact our Customer Service Department or your local distributor.
101440200 Control unit self-test wrong. 10 Contact our Customer Service Department or your local distributor.
101440300 Mechanical device reset wrong 0 Contact our Customer Service Department or your local distributor.
101440400 Control unit not supporting this command. Self-test. 3 Contact our Customer Service Department or your local distributor.
6-11
Error code Error Message Level Corrective Measure
101440401 Control unit not supporting this command. Malfunction. 5 Contact our Customer Service Department or your local distributor.
101440402 Control unit not supporting this command. Wait for 3 Contact our Customer Service Department or your local distributor.
handshake.
101440403 Control unit not supporting this command. Shutdown. 3 Contact our Customer Service Department or your local distributor.
101440404 Control unit not supporting this command. Processing 3 Contact our Customer Service Department or your local distributor.
instruction.
101440405 Control unit not supporting this command. Busy. 3 Contact our Customer Service Department or your local distributor.
101440406 Control unit not supporting this command. Mechanical 3 Contact our Customer Service Department or your local distributor.
reset.
101440500 Control unit busy. Can't respond to current instruction. 3 Contact our Customer Service Department or your local distributor.
101440600 Attempted to configure undefined speed. 0 Contact our Customer Service Department or your local distributor.
101440700 Speed configuration parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101440800 Attempted to configure undefined parameter. 0 Contact our Customer Service Department or your local distributor.
101440900 Parameter configuration beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101441000 Attempted undefined inquiry. 0 Contact our Customer Service Department or your local distributor.
101441100 Inquiry parameter beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101441200 Attempted undefined system instruction. 0 Contact our Customer Service Department or your local distributor.
101441300 System instruction parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101441400 Attempted to commission undefined position. 0 Contact our Customer Service Department or your local distributor.
101441500 Commissioning parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101441600 Not commissioned or confirmation not consistent with 0 Contact our Customer Service Department or your local distributor.
instruction.
6-12
Error code Error Message Level Corrective Measure
101441701 Tubing control failed. Washing solution surface not 9 Turn off the analyzing unit and
detected.
(1) Check whether the deionized water tank is empty and add more
deionized water to the tank as necessary.
(2) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
If the error remains, contact our Customer Service Department or your
local distributor.
101441800 Reagent disk rotation failed. Can't reach initial position. 5 Check the reagent disk as instructed by 4.4.6.5 Rgt. Disk tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101441801 Reagent disk rotation failed. Can't leave initial position. 5 Check the reagent disk as instructed by 4.4.6.5 Rgt. Disk tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101441802 Reagent disk rotation failed. Can't detect weight disk 5 Check the reagent disk as instructed by 4.4.6.5 Rgt. Disk tab.
signal.
If the error remains, contact our Customer Service Department or your
local distributor.
101441803 Reagent disk rotation failed. Reagent probe left in 5 Turn off the analyzing unit and check the types of the reagent bottles.
Reagent disk.
If the error remains, contact our Customer Service Department or your
local distributor.
101441804 Reagent disk rotation failed. Needle not at highest 5 Other errors have higher priority.
position for disk rotation.
If the error remains, contact our Customer Service Department or your
local distributor.
101441900 The aspiration/dispensing volume is wrong. The 31 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab. Check the
reagent volume exceeds the upper limit. reagent syringe as instructed by 4.4.6.7 Fluid Path tab.
If the error remains, contact our Customer Service Department or your
local distributor.
6-13
Error code Error Message Level Corrective Measure
101441902 Syringe A/D error. Can't reach initial position. 5 Check the reagent syringe as instructed by 4.4.6.7 Fluid Path tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101441903 Syringe A/D error. Can't leave initial position. 5 Check the reagent syringe as instructed by 4.4.6.7 Fluid Path tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101442000 Reagent probe rotation error. Can't reach initial 5 (1) Turn off the analyzing unit. Clean the sample disk rotor.
position.
(2) Turn on the analyzing unit and check the reagent probe as instructed
by 4.4.6.2 R. Probe tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101442001 Reagent probe rotation error. Can't leave initial 5 (1) Turn off the analyzing unit. Clean the sample disk rotor.
position.
(2) Turn on the analyzing unit and check the reagent probe as instructed
by 4.4.6.2 R. Probe tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101442002 Reagent probe rotation error. Not at v-position for 5 (1) Turn off the analyzing unit. Clean the reagent disk rotor and.
h-rotation.
(2) Turn on the analyzing unit and check the reagent probe as instructed
by 4.4.6.2 R. Probe tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101442100 Reagent probe v-move error. Can't reach initial 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
(Reagent disk/wash) position.
If the error remains, contact our Customer Service Department or your
local distributor.
101442101 Reagent probe v-move error. Can't leave initial 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
(Reagent disk/wash) position.
If the error remains, contact our Customer Service Department or your
local distributor.
6-14
Error code Error Message Level Corrective Measure
101442102 Reagent probe v-move error. Not at v-initial (Reagent 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
disk/wash) position.
If the error remains, contact our Customer Service Department or your
local distributor.
101442107 Reagent probe v-move error. Collision. 31 Turn off the analyzing unit and clear the obstacles in the path of the
vertical movement of the reagent probe.
101442108 Reagent probe v-move error. Collision transducer hold. 9 Turn off the analyzing unit and pinch the reagent probe and push it upward
to see whether it can move freely.
If the error remains, contact our Customer Service Department or your
local distributor.
101442110 Reagent probe v-move error. Current position prohibits 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
v-move (Reagent disk/wash).
If the error remains, contact our Customer Service Department or your
local distributor.
101442200 Attempted undefined simple operation. 0 Other errors have higher priority.
If the error remains, contact our Customer Service Department or your
local distributor.
101442300 Wrong cuvette position parameter in command. 0 Other errors have higher priority.
If the error remains, contact our Customer Service Department or your
local distributor.
6-15
Error code Error Message Level Corrective Measure
101442400 Illegal surface detection. 31 Turn off the analyzing unit and
(1) Check the types of the reagent bottles.
(2) Check the reagent syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the sample probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.4 Replacing Reagent Probe if
necessary.
(5) Clean the reagent probe as instructed by 5.3.2 Washing Reagent
Probe.
If this error occurs frequently, contact our company or your local distributor.
101442600 Syringe not initialized (unknown syringe current 5 Contact our Customer Service Department or your local distributor.
position)
101449000 Execution result not received within specified time. 0 Contact our Customer Service Department or your local distributor.
101449100 Command response wrong or no response. 0 Contact our Customer Service Department or your local distributor.
101449200 Sending analyzed instructions failed. 9 Contact our Customer Service Department or your local distributor.
101600100 Wrong command. Illegal frame type 31 Contact our Customer Service Department or your local distributor.
101600101 Wrong command. Not this unit's instruction 31 Contact our Customer Service Department or your local distributor.
101600102 Wrong command. Illegal command identity. 31 Contact our Customer Service Department or your local distributor.
101600103 Wrong command. Instruction length wrong 31 Contact our Customer Service Department or your local distributor.
101600104 Wrong command. Parameter significant bits wrong 31 Contact our Customer Service Department or your local distributor.
101600105 Wrong command. Other parameter wrong 31 Contact our Customer Service Department or your local distributor.
101600200 Control unit self-test wrong 10 Contact our Customer Service Department or your local distributor.
101600300 Mechanical device reset wrong 0 Contact our Customer Service Department or your local distributor.
101600400 Control unit not supporting this instruction. Self-test. 6 Contact our Customer Service Department or your local distributor.
6-16
Error code Error Message Level Corrective Measure
101600401 Control unit not supporting this instruction. Malfunction 6 Contact our Customer Service Department or your local distributor.
101600402 Control unit not supporting this instruction. Wait for 6 Contact our Customer Service Department or your local distributor.
handshake.
101600403 Control unit not supporting this instruction. Shutdown. 6 Contact our Customer Service Department or your local distributor.
101600404 Control unit not supporting this instruction. Processing 6 Contact our Customer Service Department or your local distributor.
instruction.
101600405 Control unit not supporting this instruction. Free. 6 Contact our Customer Service Department or your local distributor.
101600406 Control unit not supporting this instruction. Mechanical 6 Contact our Customer Service Department or your local distributor.
reset.
101600500 Control unit busy. Can't respond to current instruction. 6 Contact our Customer Service Department or your local distributor.
101600600 Attempted to configure undefined speed. 0 Contact our Customer Service Department or your local distributor.
101600700 Speed configuration parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101600800 Attempted to configure undefined parameter. 0 Contact our Customer Service Department or your local distributor.
101600900 Parameter value beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101601000 Attempted undefined inquiry. 0 Contact our Customer Service Department or your local distributor.
101601100 Inquiry parameter beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101601200 Attempted undefined system instruction. 0 Contact our Customer Service Department or your local distributor.
101601300 System instruction parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101601400 Attempted to commission undefined position. 0 Contact our Customer Service Department or your local distributor.
101601500 Commissioning parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101601600 System not commissioned or confirmation not 0 Contact our Customer Service Department or your local distributor.
consistent with instruction.
6-17
Error code Error Message Level Corrective Measure
101601700 Mixing bar v-move error. Can't reach initial (wash) 7 (1) Turn off the analyzing unit. Clean the mixing bar rotor.
position.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101601701 Mixing bar v-move error. Can't leave initial (wash) 7 (1) Turn off the analyzing unit. Clean the mixing bar rotor.
position.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab .
If the error remains, contact our Customer Service Department or your
local distributor.
101601702 Mixing bar v-move error. Not at v-initial position (wash) 7 (1) Turn off the analyzing unit. Clean the mixing bar rotor.
for d-move.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101601707 Mixing bar v-move error. Current position prohibits 7 Other errors have higher priorities.
v-move (wash).
Check the mixing bar as instructed by 4.4.6.3 Mixing Bar tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101601800 Mixing bar h-move error. Can't reach initial position. 7 (1) Turn off the analyzing unit. Clean the mixing bar rotor.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact our Customer Service Department or your
local distributor.
6-18
Error code Error Message Level Corrective Measure
101601802 Mixing bar h-move error. Not at h-initial position for 7 (1) Turn off the analyzing unit. Clean the mixing bar rotor.
h-rotation.
(2) Turn on the analyzing unit and check the mixing bar as instructed by
4.4.6.3 Mixing Bar tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101602000 Robotic arm v-move error. Can't reach initial (other) 9 Turn on the analyzing unit. Check the manipulator as instructed by
position 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101602001 Robotic arm v-move error. Can't leave initial (other) 9 Turn on the analyzing unit and check the manipulator as instructed by
position. 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101602100 Robotic arm h-move error. Can't reach initial position. 6 Turn on the analyzing unit and check the manipulator as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101602101 Robotic arm h-move error. Can't leave initial position. 6 Turn on the analyzing unit and check the manipulator as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101602200 Robotic arm hold error. Upper hand can't close when 6 Contact our Customer Service Department or your local distributor.
taking cuvette.
101602201 Robotic arm hold error. Upper hand can't open when 6 Contact our Customer Service Department or your local distributor.
placing cuvette.
101602202 Robotic arm hold error. Lower hand can't close when 6 Contact our Customer Service Department or your local distributor.
taking cuvette.
101602203 Robotic arm hold error. Lower hand can't open when 6 Contact our Customer Service Department or your local distributor.
placing cuvette.
6-19
Error code Error Message Level Corrective Measure
101602204 Robotic arm hold error. Upper hand accidentally open 6 Contact our Customer Service Department or your local distributor.
during movement.
101602205 Robotic arm hold error. Upper hand accidentally closed 6 Contact our Customer Service Department or your local distributor.
during movement.
101602206 Robotic arm hold error. Lower hand accidentally 6 Contact our Customer Service Department or your local distributor.
opened during movement.
101602207 Robotic arm hold error. Lower hand accidentally closed 6 Contact our Customer Service Department or your local distributor.
during movement.
101602208 Robotic arm hold error. No cuvette in compartment. 0 Check the remaining cuvettes and add more cuvettes as needed.
If the error remains, contact our Customer Service Department or your
local distributor.
101602209 Cuvette compartment not ready. 0 If there is no cuvette left in the cuvette compartment, add more cuvettes to
the compartment as instructed by 1.1.1.7 Reaction Cuvette Loader and
6-20
Error code Error Message Level Corrective Measure
101760100 Wrong command. Illegal frame type 31 Contact our Customer Service Department or your local distributor.
101760101 Wrong command. Not this Unit's instruction 31 Contact our Customer Service Department or your local distributor.
101760102 Wrong command. Illegal command identity. 31 Contact our Customer Service Department or your local distributor.
101760103 Wrong command. Instruction length wrong 31 Contact our Customer Service Department or your local distributor.
101760104 Wrong command. Parameter significant bits wrong 31 Contact our Customer Service Department or your local distributor.
101760105 Wrong command. Other parameter wrong 31 Contact our Customer Service Department or your local distributor.
101760200 Control unit self-test wrong 10 Contact our Customer Service Department or your local distributor.
101760400 Control unit not supporting this instruction. Self-test. 0 Contact our Customer Service Department or your local distributor.
101760401 Control unit not supporting this instruction. Malfunction 0 Contact our Customer Service Department or your local distributor.
101760402 Control unit not supporting this instruction. Wait for 0 Contact our Customer Service Department or your local distributor.
handshake.
101760403 Control unit not supporting this instruction. Shutdown. 0 Contact our Customer Service Department or your local distributor.
101760404 Control unit not supporting this instruction. Processing 0 Contact our Customer Service Department or your local distributor.
instruction.
101760405 Control unit not supporting this instruction. Free. 0 Contact our Customer Service Department or your local distributor.
101760406 Control unit not supporting this instruction. Mechanical 0 Contact our Customer Service Department or your local distributor.
reset.
101760500 Control unit busy. Can't respond to current instruction. 0 Contact our Customer Service Department or your local distributor.
101760600 Attempted undefined inquiry. 0 Contact our Customer Service Department or your local distributor.
101760700 Attempted undefined temperature parameter inquiry. 0 Contact our Customer Service Department or your local distributor.
101761100 Attempted undefined temperature inquiry. 0 Contact our Customer Service Department or your local distributor.
101761200 Attempted target temperature beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101761300 Attempted undefined system instruction. 0 Contact our Customer Service Department or your local distributor.
101769000 Execution result not received within specified time. 0 Contact our Customer Service Department or your local distributor.
6-21
Error code Error Message Level Corrective Measure
101769100 Command response wrong or no response. 0 Contact our Customer Service Department or your local distributor.
101769200 Sending analyzed instructions failed. 9 Contact our Customer Service Department or your local distributor.
101920100 Wrong command. Illegal frame type. 31 Contact our Customer Service Department or your local distributor.
101920101 Wrong command. Not this unit's instruction. 31 Contact our Customer Service Department or your local distributor.
101920102 Wrong command. Illegal command identity. 31 Contact our Customer Service Department or your local distributor.
101920103 Wrong command. Instruction length wrong. 31 Contact our Customer Service Department or your local distributor.
101920104 Wrong command. Parameter significant bits wrong. 31 Contact our Customer Service Department or your local distributor.
101920105 Wrong command. Other parameter wrong. 31 Contact our Customer Service Department or your local distributor.
101920200 Control unit self-test wrong. 10 Contact our Customer Service Department or your local distributor.
101920300 Mechanical device reset wrong. 0 Contact our Customer Service Department or your local distributor.
101920400 Control unit not supporting this instruction. Self-test. 8 Contact our Customer Service Department or your local distributor.
101920401 Control unit not supporting this instruction. Malfunction. 9 Contact our Customer Service Department or your local distributor.
101920402 Control unit not supporting this instruction. Wait for 8 Contact our Customer Service Department or your local distributor.
handshake.
101920403 Control unit not supporting this instruction. Shutdown. 8 Contact our Customer Service Department or your local distributor.
101920500 Control unit busy. Can't respond to current instruction. 8 Contact our Customer Service Department or your local distributor.
101920600 Attempted undefined speed. 0 Contact our Customer Service Department or your local distributor.
101920700 Speed configuration beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101920800 Attempted to configure undefined parameter. 0 Contact our Customer Service Department or your local distributor.
101920900 Parameter configuration beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101921000 Attempted undefined inquiry. 0 Contact our Customer Service Department or your local distributor.
101921100 Inquiry parameter beyond limit or unreasonable. 0 Contact our Customer Service Department or your local distributor.
101921200 Attempted undefined system instruction. 0 Contact our Customer Service Department or your local distributor.
6-22
Error code Error Message Level Corrective Measure
101921300 System instruction parameter beyond limit or 0 Contact our Customer Service Department or your local distributor.
unreasonable.
101921400 Re-disk rotation error. Can't reach initial position. 8 Check the reaction disk as instructed by 4.4.6.4 Reac. Disk tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101921401 Re-disk rotation error. Can't leave initial position. 8 Check the reaction disk as instructed by 4.4.6.4 Reac. Disk tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101921402 Re-disk rotation error. Can't detect weight disk signal. 8 Check the reaction disk as instructed by 4.4.6.4 Reac. Disk tab.
If the error remains, contact our Customer Service Department or your
local distributor.
101921500 Photoelectrical data overflow. 9 Other errors have higher priorities.
If the error remains, contact our Customer Service Department or your
local distributor.
101929000 Execution result not received within specified time. 0 Contact our Customer Service Department or your local distributor.
101929100 Command response wrong or no response 0 Contact our Customer Service Department or your local distributor.
101929200 Sending analyzed instructions failed. 9 Contact our Customer Service Department or your local distributor.
102249000 ISE unit: ISE test results are not received in given time 12 Enter the ISE Maintenance screen of the system software and click the
Handshake button.
If the error remains, shut down the analyzer unit and start it again. Enter
the System Maintenance screen, select Others tab and click the
Download Setting button.
If the error remains, contact our Customer Service Department or you local
distributor.
6-23
Error code Error Message Level Corrective Measure
102249100 ISE unit: Response error, or no response 12 Enter the ISE Maintenance screen of the system software and click the
Handshake button.
If the error remains, shut down the analyzer unit and start it again. Enter
the System Maintenance screen, select Others tab and click the
Download Setting button.
If the error remains, contact our Customer Service Department or you local
distributor.
102249200 ISE unit: disassembled instruction sending error 12 Enter the ISE Maintenance screen of the system software and click the
Handshake button.
If the error remains, shut down the analyzer unit and start it again. Enter
the System Maintenance screen, select Others tab and click the
Download Setting button.
If the error remains, contact our Customer Service Department or you local
distributor.
102409000 Bar code handshake failed 0 Check whether the barcode scanner failed.
111282100 Sample probe v-move error. Can't reach initial position. 9 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
(Re-disk)
If the error remains, contact our Customer Service Department or your
local distributor.
111282101 Sample probe v-move error. Can't leave initial position. 9 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
(Re-disk)
If the error remains, contact our Customer Service Department or your
local distributor.
111282102 Sample probe v-move error. Not at v-initial position for 9 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
d-move. (Re-disk)
If the error remains, contact our Customer Service Department or your
local distributor.
6-24
Error code Error Message Level Corrective Measure
111282106 Sample probe v-move error. Illegal surface detection. 2 Turn off the analyzing unit and
(Re-disk)
(1) Check whether the sample tubes are placed too high on the sample
disk.
(2) Check the sample syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the sample probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the sample probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.3 Replacing Sample Probe if
necessary.
(5) Clean the sample probe as instructed by 5.3.1 Washing Sample
Probe.
If this error occurs frequently. Contact our Customer Service Department
or your local distributor.
111282110 Sample probe v-move error. Current position prohibits 9 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
v-move. (Re-disk)
If the error remains, contact our Customer Service Department or your
local distributor.
111282400 V-position not initialized. (Re-disk) 9 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
If the error remains, contact our Customer Service Department or your
local distributor.
111442100 Reagent probe v-move error. Can't reach initial 9 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
position. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
111442101 Reagent probe v-move error. Can't leave initial 9 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
position. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
111442102 Reagent probe v-move error. Not at v-initial position for 9 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
d-move. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
6-25
Error code Error Message Level Corrective Measure
111442106 Reagent probe v-move error. Illegal surface detection. 0 Turn off the analyzing unit and
(Reagent disk)
(1) Check the types of the reagent bottles.
(2) Check the reagent syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the reagent probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the reagent probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.4 Replacing Reagent Probe if
necessary.
(5) Clean the reagent probe as instructed by 5.3.2 Washing Reagent
Probe.
If this error occurs frequently. Contact our Customer Service Department
or your local distributor.
111442110 Reagent probe v-move error. Current position prohibits 9 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
v-move. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
111442400 Illegal surface detection. (Reagent disk) 9 Turn off the analyzing unit and
(1) Check the types of the reagent bottles.
(2) Check the reagent syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the reagent probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(4) Check whether the reagent probe is bent or scratched. Replace the
damaged probe as instructed by 5.6.4 Replacing Reagent Probe if
necessary.
(5) Clean the reagent probe as instructed by 5.3.2 Washing Reagent
Probe.
If this error occurs frequently, contact our company or your local distributor.
6-26
Error code Error Message Level Corrective Measure
111601700 Mixing bar v-move error. Can't reach initial position. 9 (1). Turn off the analyzing unit. Clean the mixing bar rotor
(Re-disk)
(2) Turn on the analyzing unit. Check the mixing bar as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
111601701 Mixing bar v-move error. Can't leave initial position. 9 (1) Turn off the analyzing unit. Clean the mixing bar rotor
(Re-disk)
(2) Turn on the analyzing unit. Check the mixing bar as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
111601702 Mixing bar v-move error. Not at v-initial position for 9 (1) Turn off the analyzing unit. Clean the mixing bar rotor
d-move. (Re-disk)
(2) Turn on the analyzing unit. Check the mixing bar as instructed by
4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
111601707 Mixing bar v-move error. Current position prohibits 9 Other errors have higher priorities. Check the movement of the mixing bar
v-move. (Re-disk) at the maintenance screen.
If the error remains, contact our Customer Service Department or your
local distributor.
111602000 Robotic arm v-move error. Can't reach initial position. 9 Turn on the analyzing unit and check the manipulator as instructed by
(Re-disk) 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
111602001 Robotic arm v-move error. Can't leave initial position. 9 Turn on the analyzing unit and check the manipulator as instructed by
(Re-disk) 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
6-27
Error code Error Message Level Corrective Measure
121442100 Reagent probe v-move error. Can't reach initial 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
position. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
121442101 Reagent probe v-move error. Can't leave initial 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
position. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
121442102 Reagent probe v-move error. Not at v-initial position for 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
d-move. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
121442110 Reagent probe v-move error. Current position prohibits 5 Check the reagent probe as instructed by 4.4.6.2 R. Probe tab.
v-move. (Reagent disk)
If the error remains, contact our Customer Service Department or your
local distributor.
131282100 Sample probe v-move error. Can't reach initial position. 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
(Sample disk)
If the error remains, contact our Customer Service Department or your
local distributor.
131282101 Sample probe v-move error. Can't leave initial position. 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
(Sample disk)
If the error remains, contact our Customer Service Department or your
local distributor.
131282102 Sample probe v-move error. Not at v-initial position for 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
d-move. (Sample disk)
If the error remains, contact our Customer Service Department or your
local distributor.
131282110 Sample probe v-move error Current position prohibits 4 Check the sample probe as instructed by 4.4.6.1 S. Probe tab.
v-move. (Sample disk)
If the error remains, contact our Customer Service Department or your
local distributor.
6-28
Error code Error Message Level Corrective Measure
162240000 ISE unit error 12 Enter the ISE Maintenance screen of the system software and click the
Handshake button.
If the error remains, shut down the analyzer unit and start it again. Enter
the System Maintenance screen, select Others tab and click the
Download Setting button.
If the error remains, contact our Customer Service Department or you local
distributor.
200000001 Re-disk actual temperature exceeds top limit. 0 Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
If the error remains, contact our Customer Service Department or your
local distributor.
200000002 Reagent actual pre-heat temperature exceeds top limit. 0 Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
If the error remains, contact our Customer Service Department or your
local distributor.
200000003 Re-disk did not reach expected temperature within 0 Check whether the ambient temperature falls into the specified range.
specified time.
If the error remains, contact our Customer Service Department or your
local distributor.
200000004 Reagent preheat didn't reach set temperature within 0 Check whether the ambient temperature falls into the specified range.
specified time.
If the error remains, contact our Customer Service Department or your
local distributor.
200000005 Re-disk temperature fluctuates over given range under 0 Check whether the ambient temperature falls into the specified range.
normal operation
If the error remains, contact our Customer Service Department or your
local distributor.
200000006 Reagent preheat temperature fluctuate over given 0 Check whether the ambient temperature falls into the specified range.
range under normal operation.
If the error remains, contact our Customer Service Department or your
local distributor.
6-29
Error code Error Message Level Corrective Measure
200000007 Re-disk temperature control shutdown for overheating. 0 Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
Contact our Customer Service Department or your local distributor.
200000008 Preheat temperature shutdown for overheating. 0 Turn off the analyzing unit and check whether the ambient temperature
falls into the specified range.
Contact our Customer Service Department or your local distributor.
201280005 Sample probe syringe full. 0 If the error remains, contact our Customer Service Department or your
local distributor.
201280006 Sample probe syringe empty. 0 If the error remains, contact our Customer Service Department or your
local distributor.
201280007 Sample probe didn't detect fluid surface in Sample 20 Check the sample volumes in the sample tubes.
disk.
If the error remains, contact our Customer Service Department or your
local distributor.
201280009 Sample probe didn't detect fluid surface in Re-disk. 2 Reagent unit errors have higher priority.
If the error remains, contact our Customer Service Department or your
local distributor.
201280010 Insufficient dispensing of Sample probe. 0 Check the dispensing ability of the sample syringe as instructed by 4.4.6.7
Fluid Path tab.
If the error remains, contact our Customer Service Department or your
local distributor.
201440005 Reagent probe syringe full. 0 If the error remains, contact our Customer Service Department or your
local distributor.
201440006 Reagent probe syringe empty. 0 If the error remains, contact our Customer Service Department or your
local distributor.
201440007 Reagent probe didn't detect fluid surface in Reagent 30 Check the reagent volumes in the reagent bottles.
disk.
If the error remains, contact our Customer Service Department or your
local distributor.
6-30
Error code Error Message Level Corrective Measure
201440009 Reagent probe didn't detect fluid surface in Re-disk. 3 Turn off the analyzing unit and
(1) Check the remaining reagents in the reagent bottles.
(2) Check the reagent syringe for leakage as instructed by 5.2.1 Checking
Sample/Reagent Syringes.
(3) Check the reagent probe to see if there are drops hanging on the probe
tip. If there are, contact our company or your local distributor.
(3) Check the deionized water tank as instructed by 5.2.8 Checking
Remaining Deionized Water.
If the error remains, contact our Customer Service Department or your
local distributor.
201440010 Insufficient dispensing of Reagent probe. 0 Check the dispensing ability of the reagent syringe as instructed by 4.4.6.7
Fluid Path tab.
If the error remains, contact our Customer Service Department or your
local distributor.
201600009 Robotic arm can't release held Re-cuvette. Unloading 6 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
failed.
If the error remains, contact our Customer Service Department or your
local distributor.
201600010 Robotic arm can't grab used Re-cuvette from Re-disk. 6 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
201600011 Re-cuvette dropped from robotic arm. 0 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
201600012 Robotic arm didn't place used Re-cuvette. 0 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
6-31
Error code Error Message Level Corrective Measure
201600013 Robotic arm didn't grab new Re-cuvette from 6 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
compartment.
If the error remains, contact our Customer Service Department or your
local distributor.
201600014 Re-cuvette dropped from robotic arm. 0 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
201600015 Robotic arm didn't place new Re-cuvette. 6 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
If the error remains, contact our Customer Service Department or your
local distributor.
201600016 Collision occurred when unloading used cuvette. 6 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
Operation cancelled.
If the error remains, contact our Customer Service Department or your
local distributor.
201600017 Collision occurred when loading new cuvette. 6 Check the manipulator as instructed by 4.4.6.10 Autoloader tab.
Operation cancelled.
If the error remains, contact our Customer Service Department or your
local distributor.
201600018 Used cuvette compartment full. Storing segments may 0 Turn off the analyzing unit and empty the used-cuvette bucket as
cause problem. instructed by 5.2.10 Emptying Used-Cuvettes Bucket.
If the error remains, contact our Customer Service Department or your
local distributor.
201600019 Compartment empty. Can't load new segment. 0 Check the remaining cuvettes in the cuvette compartment and add more
cuvettes as needed.
If the error remains, contact our Customer Service Department or your
local distributor.
210000001 Waste tank full 13 Check and empty the waste tank as instructed by 5.2.9 Emptying Waste
Tank. If the error remains, contact our Customer Service Department or
your local distributor.
210000002 Deionized water tank empty. 13 Check and refill the DI water tank. If the error remains, contact our
Customer Service Department or your local distributor.
6-32
Error code Error Message Level Corrective Measure
400000001 System initialization error. Can't connect main unit. 10 (1) Turn off the POWER and check the connection between the analyzing
unit and the operation unit.
(2) Use the emergency exit function to exit the control system.
If this error remains, contact our company or your local distributor.
400000002 System initialization error. Main unit self-test abnormal. 10 Use the emergency exit function to exit the control system and then restart
it.
If this error remains, contact our company or your local distributor.
400000010 System initialization error. Serial port initialization error. 10 Use the emergency exit function to exit the control system and then restart
it.
If this error remains, Contact our Customer Service Department or your
local distributor.
400000012 System initialization error. Can't connect printer. 0 (1) Ensure the printer is well connected to the printer.
(2) Use the emergency exit function to exit the control system and then
restart it.
If this error remains, Contact our Customer Service Department or your
local distributor.
400000016 System initialization error. Main unit connection 10 (1) Turn off the POWER and check the connection between the analyzing
abnormal. unit and the operation unit.
(2) Use the emergency exit function to exit the control system and then
restart it.
If this error remains, contact our company or your local distributor.
400000100 Power-on pretreatment error. Lamp of insufficient 1 Other errors have higher priority.
illumination. Replacement needed.
If the error remains, change the lamp or contact our company or your local
distributor.
400000204 Updating database failed. 0 Contact our Customer Service Department or your local distributor.
400000209 Can't open help file. 0 Contact our Customer Service Department or your local distributor.
400000216 Wrong check sum for received data 0 Contact our Customer Service Department or your local distributor.
6-33
Error code Error Message Level Corrective Measure
400000220 Serial port error. Instruction can't be transmitted 10 Check the connection between the analyzing unit and the operation unit,
properly. or change the serial port. Then run the control system again.
If this error remains, Contact our Customer Service Department or your
local distributor.
400000221 Serial port error. Can't receive test data. 10 Check the connection between the analyzing unit and the operation unit,
or change the serial port. Then run the control system again.
If this error remains, Contact our Customer Service Department or your
local distributor.
400000225 Insufficient remaining reagent. 0 Check the remaining reagents for the test and add reagents to the bottles
as needed.
If the error remains, contact our Customer Service Department or your
local distributor.
400000251 Calibration sensitivity error. 0 Check the calibration settings and calibrators. Then recalibrate.
If this error occurs frequently. Contact our Customer Service Department
or your local distributor.
400000252 Calibration factor difference exceeds limit. 0 Check the calibration settings and calibrators. Then recalibrate.
If this error occurs frequently. Contact our Customer Service Department
or your local distributor.
400000253 Multi-point linear or non- linear correlated calibration 0 Check the calibration settings and calibrators. Then recalibrate.
factor (R2) exceeds limit.
If this error occurs frequently. Contact our Customer Service Department
or your local distributor.
400000254 Standard difference of calibration curve exceeds limit. 0 Check the calibration settings and calibrators. Then recalibrate.
If this error occurs frequently. Contact our Customer Service Department
or your local distributor.
400000255 Can't calculate calibration parameter by given method 0 Check the calculation method.
If the error remains, contact our Customer Service Department or your
local distributor.
400000276 Received data overflow. 10 Contact our Customer Service Department or your local distributor.
6-34
Error code Error Message Level Corrective Measure
400000281 Calibration zero concentration absorbency exceeds 1 Check the calibration settings and calibrators. Then recalibrate.
limit.
If this error remains, Contact our Customer Service Department or your
local distributor.
400000282 Incomplete calibration repeat data. Can't calculate. 1 Re-calibrate.
400000283 No calibrator. Can't calculate. 1 Re-edit the calibrator settings and re-calibrate.
400000284 Reagent out. 30 Check the remaining reagents of the test and add reagents as needed.
If the error remains, contact our Customer Service Department or your
local distributor.
400000286 Test cycle overtime. Can't continue. 9 Other errors have higher priority.
Exit the control system and then restart it.
If the error remains, contact our Customer Service Department or your
local distributor.
400000287 Excessive dark current. Test prohibited. 10 Other errors have higher priority.
If the error remains, contact our Customer Service Department or your
local distributor.
400000288 Reaction calculation error. 0 Re-run the sample.
If this error occurs frequently. Contact our Customer Service Department
or your local distributor.
400000289 Response exceeds calibration range. Can't calculate 0 Dilute the sample and rerun it.
result concentration.
400000290 Main unit can't recover from wrong status. 8 Contact our Customer Service Department or your local distributor.
400000291 Startup pretreatment error. Wrong blank test result. 10 Use the emergency exit function to exit the control system and then restart
it.
If this error remains, Contact our Customer Service Department or your
local distributor.
6-35
Error code Error Message Level Corrective Measure
400000292 Downloading parameter failed. 10 Other errors have higher priority.
Exit the control system and then restart it.
If the error remains, contact our Customer Service Department or your
local distributor.
400000293 Pretreatment not finished properly. 10 This error is triggered by other errors. Check the causes of the root errors
and take the recommended corrective measures. Use the emergency exit
function to exit the control system and then restart it.
If this error remains, contact our company or your local distributor.
400000294 Shutdown. Not finished properly. 10 This error is triggered by other errors. Check the causes of the root errors
and take the recommended corrective measures. Use the emergency exit
function to exit the control system and then restart it.
If this error remains, contact our company or your local distributor.
400000296 Concentration can't be calculated. 0 Rerun or recalculate
400000297 Calibration curve not monotone 0 Rerun the points that are not monotone, or recalibrate
400000298 Calibration interval of ** is out. Please re-calibrate in 0 Recalibrate.
time
500000001 LIS: Unconnected 0 Check if the LIS server is power on and can work properly.
Check if the line between the system and the LIS can work properly.
If this error remains, contact our company or your local distributor.
500000002 LIS: Sending HL7 message failed 0 Check if the LIS server is power on and can work properly.
Check if the line between the system and the LIS can work properly.
If this error remains, contact our company or your local distributor.
500000005 LIS: Something wrong with the network. Check the 0 Check if the LIS server is power on and can work properly.
network connection.
Check if the line between the system and the LIS can work properly.
If this error remains, contact our company or your local distributor.
6-36
Error code Error Message Level Corrective Measure
500000010 LIS: Segment sequence error in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000011 LIS: Required field missing in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000012 LIS: Data type error in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000013 LIS: Table value not found in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000014 LIS: Unsupported message type in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000015 LIS: Unsupported event code in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
6-37
Error code Error Message Level Corrective Measure
500000016 LIS: Unsupported processing id in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000017 LIS: Unsupported version id in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000018 LIS: Unknown key identifier in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000019 LIS: Duplicate key identifier in HL7 message 0 Downloading or sending the message again.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000020 LIS: Application record locked 0 Check the LIS server.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000021 LIS: Application internal error 0 Check the LIS server.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
6-38
Error code Error Message Level Corrective Measure
500000031 LIS: Application error 0 Check the LIS server.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000032 LIS: Application reject 0 Check the LIS server.
If the error remains, consult your LIS developer first.
If your LIS developer cannot resolve this problem, contact our company or
your local distributor.
500000040-50 LIS: Position …, no data found 0 Input the sample information manually.
0000098
500000099 LIS: No data found 0 Ensure there is no sample information of the current day in the LIS server.
If there is, check the LIS server.
500000101 bar code communication abnormal 0 Check whether the barcode scanner failed
500000102 bar code communication failed 0 Check whether the barcode scanner failed
500000103 %s already exists. Please change the sample ID and 0 Check and change the sample ID on LIS server, and retry.
try again.
500000104 Search conditions error. The LIS server cannot search 0 Consult the LIS developer, or contact our company or your local distributor.
for the samples.
500000105 A sample(s) without bar code is received 0 Check and change the sample ID on LIS server.
500000106 A sample(s) with invalid ID is received 0 Check and change the sample ID on LIS server.
500000107 A sample(s) without bar code and ID is received 0 Check and change the sample ID on LIS server.
500000108 Bar code %s already has a corresponding sample ID. 0 Check and change the sample ID on LIS server.
Using the sample ID from LIS is not permitted
500000109 A LIS message in incorrect format is received. 0 Consult the LIS developer, or contact our company or your local distributor.
500000110 A LIS message in incorrect format is received. 0 Delete some samples.
500000111 System busy. Auto downloading is rejected. 0 Retry when system is in standby status.
6-39
Error code Error Message Level Corrective Measure
600000001 ISE communication abnormal 12 Enter the ISE Maintenance screen of the system software and click the
Handshake button.
If the error remains, shut down the analyzer unit and start it again. Enter
the System Maintenance screen, select Others tab and click the
Download Setting button.
If the error remains, contact our Customer Service Department or you local
distributor.
600000002 ISE communication failed 12 Enter the ISE Maintenance screen of the system software and click the
Handshake button.
If the error remains, shut down the analyzer unit and start it again. Enter
the System Maintenance screen, select Others tab and click the
Download Setting button.
If the error remains, contact our Customer Service Department or you local
distributor.
600000003 ISE result returning exceeds time limit 0 Rerun to return the ISE result which previously exceeds time limit
600000030 Reading reagent pack error 0 Check if the reagent pack is connected to the wand correctly or there is
any problem with the Dallas chip of the pack. Otherwise contact our
Customer Service Department or you local distributor.
600000031 Writing reagent pack error 0 Check if the reagent pack is connected to the wand correctly or there is
any problem with the Dallas chip of the pack. Otherwise contact our
Customer Service Department or you local distributor.
600000032 Reagent expired 0 Replace the reagent pack
600000033 Reagent depleted 0 Replace the reagent pack
6-40
7 Calculation Methods
Endpoint
Fixed-time
Kinetic
7.1.1 Endpoint
The endpoint reaction is the most ideal. The reaction reaches equilibrium after
certain period. Because the equilibrium constant is very large, it can be considered
that all substrates have changed into products, and the absorbance of the reacting
liquid does not change any more. The absorbance change is proportional to the
amount of the product present.
t1 t2 t3 t
As shown in Figure 7-1, t1 is the time when the reagent is added, and t 2 is the
time when the sample is added. The reaction starts when they are mixed. At t 3 the
reaction reaches the equilibrium and the absorbance reading is taken. The reaction
time is t 3 − t 2 .
7.1.2 Fixed-Time
For the fixed-time reaction, the reaction velocity (v), within a specific period, is
proportional to the substrate concentration [S], namely, v=k[S]. As the substrate is
consumed continuously, the reaction velocity becomes smaller and smaller, and so
does the change rate of the absorbance. It takes much time for such a reaction to
reach the equilibrium. Theoretically, the absorbance reading can be taken at any
time. The reaction can, however, become steady only after a delay because it is
complicated at the beginning and there are miscellaneous reactions due to the
7-1
complex serum compositions. For any first order reaction, the substrate
concentration [S] at a specific time (t) during the reaction is:
[S ] = [S 0 ]× e − kt
Where,
k - velocity constant
Within the interval between t1 and t 2 , the relationship between Δ[S] (delta
substrate concentration) and [S0] is:
− Δ[ S ]
[ S 0] = − kt1 − kt 2
e −e
That is, within a fixed time interval, the delta substrate concentration is proportional
to the original substrate concentration, which is the generality of the first order
reactions. Within this interval, absorbance change is proportional to the substrate
concentration. See Figure 7-2.
t1 t2 t3 t4 t
As shown in Figure 7-2, t1 is the time when the reagent is added and t 2 is the
time when the sample is added. From t 3 the reaction becomes steady and t 4 is
the time to stop monitoring the reaction. The absorbance readings are respectively
taken at t 3 and t 4 .
Methodologically, the fixed-time method requires more than the endpoint method
does. All factors that have effects on the reaction velocity, such as pH, temperature
and enzyme concentration, must keep constant in the two-point analysis. In addition,
the timing must be precise and the calibration is necessary.
7.1.3 Kinetic
For the kinetic reaction, the reaction velocity is not related to the substrate
concentration and remains constant in the reaction process. As a result, for a given
wavelength, the absorbance of the reacting liquid changes evenly, and the change
rate (ΔA/min) is proportional to the activity or concentration of the subject, which is
usually the enzyme.
In fact, it is impossible for the substrate concentration to be large enough, and the
reaction will no longer a zeroth order reaction when the substrate is consumed to a
7-2
certain degree. Therefore, the theory only stands within certain period. In addition,
the reaction can become steady only after a certain period because the reaction is
complicated at the beginning and there are miscellaneous reactions due to the
complex serum compositions. All reagent manufacturers have strict specifications for
these two periods. See Figure 7-3.
t1 t2 t3 tn
t
As shown in Figure 7-3, t1 is the time when the reagent is added. t 2 is the time
when the sample is added. From t 3 the reaction becomes steady. t n is the time to
stop testing the reaction. t 3 − t 2 is the time delay, and t n − t 3 is the monitoring
time.
AD Value
Absorbance
Response
Calibration Parameter
QC Conclusion
7-3
7.2.1 AD Value → Absorbance
I0 It
As shown in Figure 7-4, when a parallel monochromatic light beam whose intensity
is I 0 goes through a flow cell (whose length is L ) containing a solution (whose
concentration is C ), some photons are absorbed, and the intensity is attenuated
from I 0 to I t , so the absorbance A of this solution is:
It
A = − Lg
I0
Where,
It
- transmissivity
I0
The analyzer measures the light intensity through the photo-electric conversion,
linear amplification and A/D conversion. For the light intensity signal I i of Channel i,
the AD output Di is:
Di = K pe ⋅ K a ⋅ K ad ⋅ I i
Where,
Di - data of Channel i
So,
Ii0 D
Ai = lg = lg i 0
Ii Di
Where,
Ai - absorbance of Channel i
7-4
Di 0 - background AD output
In theory, when the lights are off, the AD output of each channel will be zero. In
practice, because of the existence of dark currents, there is still a background
output Dibackground , which should be deducted. Then, the complete absorbance
formula should be:
Di 0 − Dibackground
Ai = lg
Di − Dibackground
The formula for calculating the response (R) is closely related to the reaction type
(kinetic, fixed-time, endpoint), the number of reagents (single, double), and the
number of wavelengths (single or double). They are respectively detailed in the
following sections.
t1 t2 t3 t
As shown in Figure 7-5, t1 is the time when the reagent (volume: V) is added. t2
is the time when the sample (volume: S) is added. The reaction starts when they are
mixed. At t 3 the reaction reaches the equilibrium and the absorbance reading is
taken. t 3 − t 2 is the reaction time. So,
R = Rs − RSMPB
Both of Rs and RSMPB are calculated with the formula R=At3 − K1 × At2 −1 .
Where,
7-5
RSMPB - response of sample blank. If the sample blank has not been requested,
RSMPB =0.
At 3 - absorbance at t3
t1 t2 t3 t4 t
As shown in Figure 7-6, t1 is the time when reagent 1 (volume: V1) is added. t 2 is
the time when the sample (volume: S) is added. Then, reagent 1 and the sample are
mixed. t 3 is the time when the reagent 2 (volume: V2) is added. Then, reagent 2 is
mixed into the reaction liquid. At t4 the reaction reaches equilibrium. t3 − t2 is the
incubation period, and t 4 − t 3 is the reaction time. So,
R = Rs − RRB
Where,
At4 - absorbance at t 4
7-6
An - absorbance at the start time of reaction
t1 t2 t3 t4 t
As shown in Figure 7-7, t1 is the time when the reagent (volume: V) is added and
t 2 is the time when the sample (volume: S) is added. t 3 is the time from which the
reaction becomes steady. t4 is the time the test on the reaction is stopped.
Absorbance is taken respectively at t 3 , t4 and the response R is:
At4 − At3
R=
t4 − t3
Double-wavelength
The response is:
Where,
7-7
Atλ42 - secondary wavelength absorbance at t4
t1 t2 t3 tn
t
As shown in the figure, t1 is the time when the reagent (volume: V) is added. t 2 is
the time when the sample (volume: S) is added. t 3 is the time from which the
reaction becomes steady. tn is the time when the test on the reaction is stopped.
t 3 − t 2 is the time delay, and t n − t 3 is the reaction time. The response ( R ) is
equal to the slope of the linear section between t 3 and tn .
Double-wavelength
The calculation method is similar to that for the single-wavelength reaction. The only
difference is that the absorbance at a certain point is equal to the primary
wavelength absorbance minus the secondary wavelength absorbance.
The linear calibration includes the single-point linear calibration (also called factor
method), two-point linear calibration (also called linear method), and multi-point (over
3 points) linear calibration (also called linear regression method). They are mainly
used for tests determined by colorimetry.
7-8
Calibration formula: R = KC
Where,
R - calibrator response
K - calibration parameter
R
This calibration method adopts only one calibration parameter K , and K= .
C
This calibration method requires only one calibrator. For most enzyme tests, you can
input the factor directly (input value F=1/ K ) without any calibration.
Where,
R - calibrator response
C - calibrator concentration (or activity)
K , b - calibration parameters
This calibration method adopts two calibration parameters: K and b.
R2 − R1
K=
C 2 − C1
R2 − R1
b = R1 − ( ) × C1
C 2 − C1
This calibration method requires two calibrators. C 1 and C 2 are respectively the
concentrations of calibrator 1 and calibrator 2. R 1 and R 2 are respectively the
responses of calibrator 1 and calibrator 2.
Where,
R - calibrator response
C - calibrator concentration (or activity)
K , b - calibration parameters
This calibration method adopts two calibration parameters: K and b.
7-9
n n n
∑ Ci
i =1
2
− (∑ Ci ) 2 / n
i =1
n n n
n ∑ CiRi − (∑ Ci)(∑ Ri) / n n
b = ( ∑ Ri ) / n − [ i =1 i =1 i =1
]( ∑ Ci ) / n
n n
i =1
∑ Ci 2 − (∑ Ci) 2 / n i =1
i =1 i =1
The calculation formulas for non-linear calibration rules are described below. R0, K, a,
b, c and d are calibration parameters, i refers to any calibrator.
Logistic-Log 4P
Calibration formula:
Where,
R - calibrator response
K , R 0, a , b - calibration parameter
This calibration method is applied to the calibration curve that the response becomes
smaller and smaller with the concentration increase. See Figure 7-9.
C1 C2 C3 C4 C
Logistic-Log 5P
Calibration formula:
7-10
Where,
R - calibrator response
K , R 0, a , b , c - calibration parameter
The applications of the calibration method are the same with that of Logistic-Log 4P,
but this method has a higher fitting.
Exponential 5P
Calibration formula:
Where,
R - calibrator response
K , R 0, a , b , c - calibration parameter
This calibration method is applied to the calibration curve that the response
increases sharply when the concentration reaches a specific value. See Figure 7-10.
C1 C2 C3 C4 C5
C
Polynomial 5P
Calibration formula:
Where,
7-11
R - calibrator response
R 0, a , b , c , d - calibration parameter
This calibration method is applied to the calibration curve that the response
increases sharply when the concentration reaches a specific value.
Parabola
Calibration formula:
Where,
R - calibrator response
a, b, c - calibration parameter
Spline
Calibration formula:
Where,
R - calibrator response
This calibration method requires 2-6 calibrators. Because this method adopts the
segment fitting, its fitting degree is the highest among all calibration types.
7-12
7.2.4.1 Result calculations after linear calibrations
Single-point linear calibration
R
C=
K
Where,
K - calibration parameter
Or,
C = R×F
Where,
F - input factor.
K, b - calibration parameters
K, b - calibration parameters
Logistic-Log 5P
Obtain the positive real root with the dichotomy method.
7-13
Exponential 5P
Obtain the positive real root with the dichotomy method.
Polynomial5P
R − R0 R − R0 R − R0
C = exp( a + b ( ) + c( )2 + d ( )3 )
100 100 100
Where,
Parabola
Obtain the positive real root of the following linear quadratic equation:
aC 2 + bC + c − R = 0 .
Spline
Obtain the positive real root with the dichotomy method.
7-14
QC conclusion flow:
QC Data
No
12S within control
Yes No
No No No No
22 S R4 S 41 S 10 x
13 S
out-of-control
7.2.5.2 X -R
This rule obtains the difference (R) between two tested values (X1 and X2) of a same
control, and then compares it with the input SDR. If R is larger than 2SDR or smaller
than -2SDR, the rule considers it out-of-control. The value of SDR should be obtained
in the following procedures: After pre-testing the control, test it continuously for 20
days. Test it twice before and after adding the sample everyday. Obtain the SDR of
the difference (R) between two tested values (X1 and X2).
7-15
7.2.5.4 Cumulative error
This rule calculates the difference (error, expressed with the symbol plus or minus)
between the tested value and target value of a test of a control.
When the cumulative error overruns the cumulative error limit E or –E, the system
considers it out-of-control.
7.2.5.5 Twin-plot
+3SD
+2SD
-2SD
-3SD
The QC chart, which can sensitively indicate system errors and random errors, is present to
help you make a QC conclusion.
Ex = Es + RT/nF log (µ C)
Where,
The calculation process of the concentration of the ion in the sample is as the following steps.
7-16
First, the module measures the potential of the calibrant A and calibrant B and calculates the
slope S of the electrode with the formula below.
EA − EB
S=
C
log A
CB
where,
Second, the module calculates the concentration of the ion in the sample with the formula
below.
E X −E A
C X = C A × 10 S
Where,
7-17
7-18
Appendix A Specifications
Sample volume: 2μl-45μl; for the ISE unit (optional), 70μl serum, 70μl plasma,
140μl diluted urine; precision: 0.1μl
Sample Disk: 60 sample tube positions; 5 virtual disks for maximum 300 samples
Compatible sample containers: micro-tubes, collection tubes and test tubes of the
following sizes: Φ12mm×68.5mm, Φ12mm×99mm, Φ12.7mm×75mm,
Φ12.7mm×100mm
STAT samples: can be inserted immediately for analysis with higher priority
Sample probe: with a built-in level detector; equipped with bump collision
safeguard; capable of tracking sample level
Washing function: automatically washing interiors and exteriors of sample probe
Auto rerun
Mixing bar: for single-reagent tests, it functions immediately (within the same
period) after sample dispensing; for double-reagent tests, it functions immediately
(within the same period) dispensing of the second reagent.
A-1
Measurement period: 12 seconds
Measurement range: 0.1-4.0 Abs
Lamp: tungsten-halogen;
A.3 EMC
This equipment complies with the emission and immunity requirements described in
EN 61326-1:2006 and EN 613262-6:2006.
A.7 PC
CPU: 2.5GHz or above;
Memory: 1GB or above;
Hard disk: 160 GB or above;
Monitor screen solution: 1024 x 768;
Operating software: Windows XP ( home/professional ) SP2 or above; or
Windows 7 Home Basic 32 or above;
Interface: Net, USB and RS-232C.
A-2
A.8 Input/Output Devices
PC Keyboard
PC Mouse
Printer
Display
A.9 Interface
LIS interface: HL7 interface developed by our company.
Interface between Analyzing Unit and Operation Unit: RS-232C
The bar code labels can be applied to the following sample tubes.
Φ12mm ×99mm
Φ12.7mm×75mm
Φ12.7mm×100mm
A-3
Analyte (urine) Test range limit (mmol/l)
K+ 5-200
Na+ 10-500
Cl- 15-400
A-4
Appendix B Supplies
To ensure personal safety and system performance, use only supplies manufactured
or recommended by our company. Contact our Customer Service Department or
your local distributor for details.
B-1
Description Part Number Location Remarks
Sample probe assembly BA40-30-61525 Sample Replacing part
probe arm
Replace it when
1) It serves for 1
year; or
2) It is damaged
or bent.
Sample probe gasket 0040-10-32307 Nut on the Replacing part
sample
Replace it when
probe
1) The sample
probe is
disassembled for
2 - 3 times; or
2) The sample
probe is replaced
with a new one.
Filter assembly BA31-30-41412 Deionized Replacing part
water tank
Replace it every
6 months.
Reagent probe gasket 0040-10-32307 Nut on the Replacing part
reagent
Replace it when
probe
1) The reagent
probe is
disassembled for
2 - 3 times; or
2) The reagent
probe is replaced
with a new one.
Mixing bar 801-BA20-0005 Mixing bar Replacing part
4-00 arm
Replace it when
it is damaged.
A4 copy paper 0150-10-00381 Printer Consumable
Reaction cuvette BA30-20-15179 Reaction Consumable
disk
Inner-circle bottle BA30-20-15058 Reagent Consumable
disk
Outer-circle bottle BA30-20-15059 Reagent Consumable
disk
B-2
Appendix C Index
4-70, 4-71, 4-72, 4-73, 4-74,
—A—
4-76, 4-78, 4-92
absorbance ...... 1-15, 3-4, 4-3, 4-40,
Calibrator .................................. 1-4
4-41, 4-42, 4-43, 4-44, 4-44,
4-45 carryover ................................9, 3-5
acid .................................4-37, 4-38 check box 1-19, 3-6, 4-3, 4-4, 4-16,
4-42, 4-51, 4-95, 4-96, 4-97,
Acid wash solution .................... 5-2
4-134, 4-135, 4-136, 4-137,
administrator...................3-4, 4-141 4-166, 4-167
C-1
dialog box ..... 1-18, 3-4, 4-16, 4-21, hydrochloric .............................4-37
4-22, 4-25, 4-26, 4-27, 4-37,
4-38, 4-46, 4-47, 4-51, 4-61, —I—
4-66, 4-70, 4-81, 4-87, 4-91,
4-119, 4-133, 4-135, 4-137, Incubation ....................... 3-4, 4-41
4-141, 4-166, 4-167, 4-169
inner circle ....................... 1-4, 4-62
Diluents ..................................... 1-4
Intercept ...................................4-45
dilution ratio ............................ 4-44
Door —J—
Fixed Time ............................ 4-137 middle door ............. 1-8, 1-10, 1-14
mixer ........................................1-12
—G—
mixing bar4, 8, 1-12, 3-2, 3-4, 4-38,
Gasket...................................... 5-46 4-134
—H— —O—
handle ................... 4, 1-5, 1-9, 1-10 operation unit ........ 7, 1-1, 1-4, 1-16
Handle ....................................... 1-5 optical path..................... 1-14, 1-15
handwheel................. 1-5, 1-9, 1-10 option button ................ 1-19, 4-136
Handwheel................................. 1-5 outer circle ....................... 1-4, 4-62
Help ..................................1-17, 4-1 output unit ........................ 1-1, 1-16
horizontal position .... 1-5, 1-9, 1-10
—P—
hospital name......................... 4-141
Parameters......1-17, 3-4, 4-1, 4-38,
Humidity.................................... 2-2 4-39, 4-40, 4-61, 4-66, 4-95,
4-96
C-2
password3-4, 4-27, 4-38, 4-61, 4-66, reaction disk ..1-8, 1-11, 1-12, 1-14,
4-87, 4-133, 4-141 1-15, 3-4, 4-18
tube ............................................ 1-4 reagent disk ...7, 1-9, 1-10, 3-5, 3-7,
4-62, 4-63
position for reagent 1............... 4-62
reagent dispenser......................1-10
position for reagent 2............... 4-62
reagent syringe .......... 1-8, 1-10, 3-2
Power
Refrigerator ............................... 1-9
cord.................................... 2-2, A-2
relative humidity ....................... 2-2
socket......................................... 2-2
report header ..........................4-165
POWER ..............................3-3, 3-7
Requested,.......................... 3-5, 3-6
power socket.......................2-2, 3-2
re-runs ....................................4-133
power supply .............. 1-9, 2-2, 3-2
response.......4-44, 4-45, 4-75, 4-76,
Power Supply............................. 2-2 4-137
primary wavelength ................. 4-40 response range........................4-137
printing order ..............4-165, 4-167 Routine 1-17, 4-1, 4-11, 4-12, 4-13,
4-14, 4-37, 4-133, 4-134
probe...............................5-32, 5-39
Running............................. 3-5, 3-6
probe arm..........................1-7, 1-10
C-3
sample tube.......... 1-4, 1-5, 1-7, 1-8 test report ................... 4-165, 4-167
Sampling.................................. 5-46
—U—
scroll bar .................................. 1-20
unit ... 1-1, 1-4, 1-11, 1-13, 3-2, 3-3,
second reagent ...... 1-12, 4-41, 4-42 3-7, 4-40, 4-138, 4-139
Syringe —V—
C-4
P/N:046-002585-00(1.0)