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Operation Manual
2008 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operators Manual, the issued Date is 2008-09 (Version: 1.0).
, BeneView, WATO,
NOTE:
This equipment
professionals.
must
be
operated
by
skilled/trained
clinical
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.
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.
This warranty shall not extend to:
Return Policy
Return Procedure
In the event that it becomes necessary to return this product or part of this product to
Mindray, the following procedure should be followed:
1
Freight policy: The customer is responsible for freight charges when this
product is shipped to Mindray for service (this includes customs charges).
Return address: Please send the part(s) or equipment to the address offered
by the Customer Service department
ii
Company Contact
Manufacturer:
Address:
Tel:
Fax:
EC Representative
Name:
Address:
Phone:
0049-40-2513175
Fax:
0049-40-255726
iii
Preface
Before using the system, please read this operation manual thoroughly for relevant operation instructions.
Please keep this manual properly for convenient use.
Intended Reader
This manual is geared for clinical professionals to:
Conventions
Safety Symbols
Safety symbols alert you to potentially dangerous conditions and information that requires your attention.
These safety symbols, together with related text, apply to specific procedures and appear as needed
throughout this manual.
Then
WARNING
BIOHAZARD
NOTE
CAUTION
Labels
The labels attached to the surface of the instrument use symbols to clarify the
meaning of the text. If any of the labels peels off, contact our company customer
service department or your local distributor for replacement. The chart below
explains the symbols on the labels.
Serial number
Manufacture date
Manufacturer
Authorized Representative in the
European Community
The following definition of the WEEE label
applies to EU member states only: The use of
this symbol indicates that this product should
not be treated as household waste. By
ensuring that this product is disposed of
correctly, you will help prevent bringing
potential negative consequences to the
environment and human health. For more
detailed information with regard to returning
and recycling this product, please consult the
distributor from whom you purchased the
product.
In Vitro diagnostic equipment
Biohazard Warning: Risk
biohazardous infection
of
potentially
AC 100-240V, 50/60Hz
Power ON
Power OFF
Serial port to connect the equipment to PC
USB port, which complies with the USB 2.0
protocol.
Graphics
All graphics, including screens, are for illustration purpose only and must not be
used for any other purposes.
Safety Precautions
Observe theses safety precautions when using the system. Ignoring any of the
precautions may lead to personal injury or equipment damage.
WARNING
If the instrument is used in a manner not specified by our company, the
protection provided by the system may be impaired.
WARNING
When the instrument is turned on, users must not open the 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 spillage, switch off the power immediately,
remove the spillage and contact our company customer service
department or your local distributor.
This instrument is supplied with a slow-blow fuse (250V, 3.15A), which
must not be replaced by the user.
Power supply: 100-240V~, 50/60Hz.
The instrument is supplied with a three-wire power cord and should be
properly grounded during application.
WARNING
Do not put your finger or hand into any open part when the system is
in operation.
WARNING
Light sent by the photometer lamp may hurt your eyes. Do not stare into
the lamp when the system is in operation.
If you want to replace the photometer lamp, first switch off the Main
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.
Preventing Infection
Please observe the following instructions to protect against the biohazardous
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
procedures and consult a doctor.
BIOHAZARD
Some substances in reagent, control, enhanced wash solution and
waste are subject to regulations of contamination and disposal. Dispose
of them in accordance with your local or national guidelines for
biohazard waste disposal and consult the manufacturer or distributor of
the reagents for details.
Wear gloves and lab coat and, if necessary, goggles.
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. Please exercise caution while using
the ethanol.
Precautions on Use
To use the system safely and efficiently, please pay much attention to the following
operation notes.
Intended Use
WARNING
The system is an analyzer designed for in vitro quantitative
determination of clinical chemistries in serum, plasma, urine and CSF
samples. Please consult Mindray first if you want to use the system for
other purposes.
To draw a clinical conclusion, please also refer to the patients clinical
symptoms and other test results.
Operator
WARNING
The system is to be operated only by clinical professionals, doctors or
laboratory experimenters trained by our company or our authorized
distributors.
Environment
CAUTION
Please install and operate the system in an environment specified by
this manual. Installing and operating the system in other environment
may lead to unreliable results and even equipment damage.
To relocate the system, please contact our customer service department
or your local distributor.
NOTE
It is the manufacturer's responsibility to provide equipment
electromagnetic compatibility information to the customer or user.
NOTE
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.
Samples
CAUTION
Use samples that are completely free of insoluble substances like fibrin,
or suspended matter; otherwise the probe may be blocked.
Medicines, anticoagulants or preservative in the samples may lead to
unreliable results.
Hemolysis, icterus or lipemia in the samples may lead to unreliable test
results, so a sample blank is 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 a long period.
Some samples may not be analyzed on the system based on
parameters the reagents claim capable of testing. Consult the reagent
manufacturer or distributor for details.
Certain samples need to be processed before being analyzed by the
system. Consult the reagent manufacturer or distributor for details.
10
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.
Communication interface
CAUTION
The system is equipped with two USB ports which can be used in
connecting the keyboard, mouse, printer and other external
equipments or in system upgrading. RS232 is used in connecting the
PC with the analyzer to transfer data.
These three ports should not be used to operate the system for usage
other than those mentioned above. Otherwise, system might be
damaged.
11
Contents
Preface ............................................................................................................................... 1
Contents ............................................................................................................. I
1
1.2
1.3
1.4
2.1
Unpacking............................................................................................................. 2-1
2.2
Installation............................................................................................................. 2-1
2.3
Installation............................................................................................................. 2-3
2.3.1
2.4
2.5
3.2
Installation.............................................................................................2-1
2.2.1
2.2.2
2.2.3
2.2.4
2.2.5
Overview.................................................................................................. 1-1
Outlook .................................................................................................... 1-1
3.3
Edit........................................................................................................................ 3-6
3.4
Shutdown.............................................................................................................. 3-6
Advanced Operations...........................................................................4-1
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.3
Test .....................................................................................................................4-13
4.3.1
4.3.2
Calibration...........................................................................................................4-19
4.5
QC.......................................................................................................................4-22
4.6
Result..................................................................................................................4-23
4.7
4.8
Result.....................................................................................................4-24
Edit.........................................................................................................4-27
Setup...................................................................................................................4-30
4.7.1
4.7.2
4.7.3
4.7.4
4.7.5
Basic ......................................................................................................4-31
Dictionary ...............................................................................................4-32
Print Features ........................................................................................4-33
Carryover ...............................................................................................4-34
LIS Setup ...............................................................................................4-35
Maintenance .......................................................................................................4-36
4.8.1
4.8.2
4.8.3
4.8.4
Database................................................................................................4-36
Log .........................................................................................................4-37
Maintenance ..........................................................................................4-38
Shutdown ...............................................................................................4-39
5.2
5.3
Irregular Maintenance...........................................................................................5-2
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
Request..................................................................................................4-13
Test ........................................................................................................4-15
4.4
4.6.1
4.6.2
Routine.....................................................................................................4-2
Profile.......................................................................................................4-9
Calculation ...............................................................................................4-9
Off-system..............................................................................................4-12
6.2
6.3
Calculating Concentration.....................................................................................6-4
6.3.1
6.3.2
6.4
QC Rule ................................................................................................................6-6
6.4.1
Westgard Multi-rule..................................................................................6-6
Appendix A
Specifications ........................................................................A-1
Appendix B
II
Appendix C
Appendix D
Supplies................................................................................. D-1
III
1
1.1
System Description
Introduction
1.1.1 Overview
The system consists of the analyzer, built-in microprocessor, popup keyboard,
internal printer and LCD screen.
1.1.2 Outlook
The front view of the semi-auto chemistry analyzer is shown in figure 1-1.
1-1
The rear view of the semi-auto chemistry analyzer is shown in figure 1-2.
Figure 1-2 Rear View of the Semi-Auto Chemistry Analyzer
1-2
USB port is to connect the printer and other external equipments; serial port is to
transmit the data after connected to PC.
1.2
1.3
Parameters
Light source
Filter
Absorbance range
03.0A
Readable range
03.5A
Result resolution
0.001A
Reaction container
Reaction temperature
Weight
7kg
Dimension
420mm350mm158mmlengthwidthheight
Power supply
Input power
140VA
CAUTION
Be sure to use the supplied pen to operate the touchscreen. Do not
touch the screen with sharp-edged tools. Otherwise the screen may be
damaged.
1.3.1 Touchpen
The system is provided with a touchscreen and pen, which are used as input tools
and can be operated as follows:
Click
Click means the act of moving the pen to the desired item and then touching the
screen gently.
1-3
The click operation is used to operate all buttons, options, edit boxes and popup
keypad.
Drag
Drag means the act of keeping touching the screen with pen and moving to desired
place.
The drag operation is used to move the scroll bars.
1.4
Continuously click Ctrl for two times to switch between English and Chinese.
Select
Select
and click a letter. The letter is input in upper case, but the
following letters will be input in lower case.
Select
and
. All letters you then enter are input in upper case. Select
Printer
Before feeding printing paper, please ensure the instrument has been powered
off.
After feeding printing paper, be sure to cover the record.
1-4
CAUTION
Do not use any tools like sandpaper that may damage the thermal
components. Do not squeeze the thermal print head.
NOTE
The paper used for the thermal recorder should be 50mm20m.
WARNING
The printer must be connected to properly-grounded power socket.
NOTE
You are recommended to use printers that are compatible with the
system and listed in (not limited to) Appendix. If you have any
questions about the printers, please contact our company customer
service department or your local distributor.
Plug the data cable to the USB port on the back of the instrument.
1-5
2
2.1
Installation
Unpacking
When you receive the system, carefully inspect the package. If you see any signs of
mishandling or damage, file a claim immediately with Mindray 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 system. If you find anything missing or damaged,
immediately alert Mindray customer service department or your local distributor.
2.2
Installation
2-1
WARNING
Please make sure that the power is properly grounded. Improper
grounding may lead to electric shock and/or equipment damage. Be
sure to connect the system to a power socket that meets the
above-mentioned requirements and has a proper fuse installed.
The installation space must be larger than the dimensions (420mm 350mm
158mm, LWH) of the instrument. Please refer to Figure 2-1.
The installation platform should be level with gradient less than 1:200.
2-2
NOTE
The waste bottle should not be sealed, otherwise the peristaltic pump
can not function to aspirate.
2.3
Installation
Installation procedure:
1
After the system is delivered to your place, check the delivered goods
against the packing list
Place the system on the operating platform and ensure at least 200mm
distance between the system and the wall. Remove the package of the
system;
Connect the power cable, turn on the analyzer and the system is started.
The system will enter the main screen after self-check and tubing washing.
If cuvette mode is selected, tubing wash is not needed.
After system is stabilized, request 1-2 tests and run. Evaluate the test
results.
After confirming that the system works normally, shutdown the system
following the instruction indicated in this manual.
WARNING
The system is equipped with three-wire power cord. Make sure the
power socket is grounded correctly. Improper grounding may lead to
electric shock and/or equipment damage.
Be sure to connect the system to a power socket that meets the system
requirements and has a proper fuse installed.
2-3
CAUTION
Before connecting the power supply, make sure the system is
shutdown.
2.4
2.5
NOTE
When storing the analyzer for long period, please ensure that no liquid
in the flow cell and the tubing (for instrument with flow cell installed).
2-4
3
3.1
Basic Operations
BIOHAZARD
Wear gloves and lab coat and, if necessary, goggles when performing
the following operations.
Check the power supply and make sure it can supply proper voltage for the
analyzer.
Check and make sure sufficient printing paper is prepared for the printer. If not,
feed more printing paper.
If external printer is applied, check if the data cable has been connected to the
system. Check if the power cord of the printer is properly connected.
3-1
Check if the waster tube at the back of the system is connected to the waste bottle
or other disposal channels. Check if the waste bottle is full. If yes, empty the waste
bottle.
NOTE
Twisted tubing will make the system incapable of aspiration (for system
installed with flow cell). Please check before use, ensuring Ensure the
tubing is not blocked, bent, or twisted.
CAUTION
It will take 15 minutes or more for the lamp and temperature control
system to be stable, after the system is started.
3.2
Timing Principle
Press the power button of the printer (if internal thermal recorder is
applied, skip this procedure).
Place the power switch to On. The system starts initialization which takes
about 2 minutes. During this process, aspirate DI water as directed by the
message on the screen. After initialization and self-check, the main
screen is displayed
3-2
Click Parameter Routine. Basic. Follow the reagent instruction to enter the
test parameters concerning reaction type, primary wavelength, secondary
wavelength, delay, measuring time, result unit, result precision and reaction
temperature, whether to run reagent blank, etc. Refer to 4.2.1.1 Basic for more
information.
Click Parameter Routine Cal Details. For Kinetics, you can enter the K
factor according to the reagent instruction, or select proper calibration rule. For
Endpoint and Fixed-time analysis, select proper calibration rule and enter the
set points of the calibrators. Refer to 4.2.1.3Calibration for more information.
Click Parameter Routine Restriction. Enter the reference range. You can
determine whether it is necessary to enter linearity range, reagent blank
absorbance, absorbance limit and linearity limit, etc. Refer to 4.2.1.2
Restriction for more information.
Click Parameter Routine QC Information. Enter control lot No. mean
concentration and SD and select proper QC rule. Refer to 4.2.1.4 QC
Information for more information.
NOTE
The displayed absorbance is the result of the real absorbance
multiplied with 10000, so the absorbance you enter should also be
multiplied with 10000, but this does not affect the calculation of the
final result.
3.2.1.3 Test
For Endpoint analysis, the test workflow is slightly different from that of the
Fixed-time and Kinetics analysis. The following introduces them separately.
NOTE
The displayed absorbance is the result of the real absorbance
multiplied with 10000, but this does not affect the calculation of the final
result.
3-3
Endpoint
1
NOTE
Check the reagent instruction, or consult the
reagent manufacturer or distributor to see if mixing
of R1 and R2 are allowed prior to testing.
Incubate the tube in a water bath tank or external incubator for a while.
Click Water Blank, put the inlet tube into the distilled water, and click
Aspirate.
Click Reagent Blank, put the inlet tube into the reagent blank, and click
Aspirate.
10
Select Calibrate and select calibrator in the drop down list box of S1-S8.
Put the inlet tube into the calibrator to be tested and click Aspirate. If it is
multiple-point calibration, you can proceed to the next step only when the
calibration tests of all the calibrators are completed. Put the inlet tube
into the sample blank, and click Aspirate.
12
NOTE
You can determine whether it is necessary to run
sample blank.
Hemolysis, icterus or lipemia in the samples may
lead to unreliable test results, so a sample blank is
recommended.
13
Select Sample ID and click Sample. Put the inlet tube into the sample
and click Aspirate. Repeat this to test other samples.
14
15
After all the tests are completed, put the inlet tube into the distilled and
click Wash.
3-4
NOTE
Check the reagent instruction, or consult the reagent
manufacturer or distributor to see if mixing of R1 and
R2 are allowed prior to testing.
Click Water Blank, put the inlet tube into the distilled water, and click Aspirate.
Click Reagent Blank, put the inlet tube into the reagent blank, and click
Aspirate.
Select Calibrate and select calibrator in the drop down list box of S1-S8.
Dispense calibrator into the tube with reagent in it. Put the inlet tube into the
calibrator to be tested and click Aspirate. If it is multiple-point calibration, you
can proceed to the next step only when the calibration tests of all the
calibrators are completed. (If K factor is manually entered, skip it)
Put the inlet tube into the sample blank, and click Aspirate.
Select Sample ID and click Sample. Put the inlet tube into the container where
sample is mixed well with the reagent and click Aspirate. Repeat this to test
other samples.
After calibration is finished. Click QC and select controls from the drop-down
list box C1-C3. Put the inlet tube into the container where control is mixed
well with the reagent and click Aspirate.
10
After all the tests are completed, put the inlet tube into the distilled and click
Wash.
CAUTION
For flow cell, if the system switches to other tests or after test of high
concentration sample is run, wash the flow cell (for cuvette, washing
should be done after every test). Otherwise, the result might be
unreliable.
3-5
NOTE
Make sure the cuvette cover and the optical window is closed, during
test, otherwise the test result might not be reliable.
3.3
Edit
During test, the online printing is enabled by default and the test result of each
sample is printed in real time. Patient information and test result can be edited to
print the report.
On the main screen, click Result Sample. Select the sample to be edited and
click Edit to enter the patient information including name, gender, age, etc. Click
Print to print the patient report.
3.4
Shutdown
Click Shutdown on the main screen. Please follow the instructions displayed on the
screen to wash the tubes with distilled water and then wait for 20 seconds.
Shutdown the printer (external printer) and the analyzer. During this process, test
information, system setup, patient information and test result will be saved.
3-6
4
4.1
Advanced Operations
Powering On
Power on the analyzer and the system will go through initialization procedure as
shown in the following figure.
Figure 4-1 Initialization Screen
After passing the self-checking, the system will prompt message to aspirate distilled
water. Press Aspirate button on the instrument. After aspiration, the main screen will
be displayed.
4-1
If the system failed to pass self-checking, the initialization will be terminated and the
main screen will be displayed. Please contact Mindray customer service department
or your local distributor for troubleshooting.
NOTE
If the system failed to pass self-checking, most of the operation
including running test will be disabled, except for same inquiry. Please
refer to 4.3 Test for more information.
After initialization, the main screen will appear as shown in figure 4-2.
Figure 4-2 Main Screen
4.2
Parameter
Click Parameter to enter the parameter screen as shown in figure 4-3.The tests
include routine, profile, calculation and off-system. The left list indicates the name of
the saved tests; the right list indicates the information of the selected test.
Click Add, Delete, Save and Cancel to add, modify and delete test information.
4.2.1 Routine
The test information includes the basic information (such as calculation methods,
wavelengths, etc.), restriction information ( such as reference range) and information
about calibration and QC.
4.2.1.1 Basic
Click Add to enter the screen shown in figure 4-3. The Routine includes: Basic,
Restriction, Cal details and QC Information.
4-2
Parameter
Description
Test
The test name should be set and same test names are not allowed.
The length of the test name should not exceed 10 characters.
Otherwise, warning messages will appear.
Reac. Type
Direction
Pri.
Sec.
Delay
A period between the end of the aspiration and the start of the test.
Acceptance range is 6-999 sec. The minimum increment or
decrement is 1 sec.
4-3
Parameter
Description
NOTE
The delay is mainly to balance the reaction
temperature and eliminate the effect of small
bubbles. For Endpoint and Absorbance analysis, the
delay is usually set as 6-10 sec. For Fixed-time and
Kinetics analysis, it is mainly used to eliminate the
effect of unwanted reactions, usually set as 30-60s.
Refer to the reagent instruction for more details.
Measuring
time
NOTE
The measuring time for endpoint analysis is usually
around 5sec; for Fixed-time and Kinetics, please
refer to the reagent instruction and it is usually more
than 30sec.The reading interval is 1 sec for single
wavelength and 2sec for double wavelengths.
Unit
Unit of the result. Select from the drop-down list. The options
include g/L, mmol/L, umol/L, U/L, mg/dL, IU/L, mg/L and void. The
default is void. The units can be added and deleted in Setup.
Precision
Precision of the result. Select from the drop-down list 1, 0.1, 0.01,
0.001.The default is 1.
Asp. Vol.
Rgt. Blank
NOTE
Reagent blank must be run for endpoint analysis.
For Kinetics, Fixed-time and Absorbance analysis,
refer to the reagent instruction to decide whether to
run.
Temp.
Full name
4-4
Buttons
Function
Add
Delete
Save
Cancel
After selecting a test and setting or modifying parameters for it, click
this button to cancel the setting or modification.
Return
4.2.1.2 Restriction
Enter the test reference range, linearity range, absorbance limit and so on in
Restriction page to evaluate the result and to note the operator.
Figure 4-4 Restriction information
Description
Default
reference
Lin. Range
4-5
Parameter
Description
Reagent blank Absorbance range of the reagent blank. Once this range is
absorbance
exceeded, error message will appear.
The reagent blank absorbance should be entered from low to
high. The high and low limit should not be equal. The default is
void.
NOTE
The absorbance of reagent blank is entered in the
format of real value10000.
Absorbance
limit
NOTE
The absorbance limit is entered in the format of
real value10000.
Lin. Limit
It is only valid for Kinetics. The range is 0-1. The default is void.
0 means no check.
By Diff.
Function
Save
Cancel
After selecting a test and setting or modifying parameters for it, click
this button to cancel the setting or modification.
Return
4.2.1.3 Calibration
The Cal Details screen is where you can set the test calibration information
including calibration rule, calibrator concentration and replicates.
4-6
The following table explains the parameters on the Cal Details screen.
Parameter
Description
K factor
Rule
Calibration rule.
Replicate
It refers to the times of each calibration test. It ranges from 1-3. The
default is 1.
Set the number of calibrators and the calibrator set point. The set
point of the calibrator is arranged from lowest to highest. The void
means 0 concentration. If set points are not set according to the
above rules, error message will appear.
S1-S8
NOTE
After the information about the number of the
calibrators and the set points are modified, the
existing information about calibration parameters
and calibration curve will be deleted, so recalibration
is required.
Function
Save
Cancel
Return
4-7
4.2.1.4 QC Information
The QC Information screen is where you can set the test QC rule and control
information.
Figure 4-6 QC information
Description
Rule
Set QC rule for the selected test. One or more rules can be
selected, or none is selected.
Control
Function
Save
Cancel
After selecting a test and setting or modifying parameters for it, click
this button to cancel the setting or modification.
Return
4-8
4.2.2 Profile
Tests grouped together for certain clinical purposes (for instance liver function)
constitute a profile.
Figure 4-7 Profile
Profile name list is on the left side of the screen, all the on-board test names are
listed on the right side of the screen. Select a profile name on the left side and the
tests it includes will shown are the list on the left side.
The following table explains the parameters on the Profile screen.
The following table introduces the buttons on the page.
Buttons
Function
Add
Add a new profile. Enter the profile name in the Profile name text box,
select tests in the list below the box, and then click save.
Delete
Delete the selected profile. The tests listed on the right side of the
screen can not be deleted.
Save
Cancel
After selecting a test and setting or modifying parameters for it, click
this button to cancel the setting or modification.
Return
4.2.3 Calculation
Calculating certain tests can derive certain new tests of clinical purpose.
Calculation name list is on the left side of the screen, detailed information of the
selected calculation is shown on the right side.
4-9
Description
Test
The test name should be set and same test names are not
allowed..
The length of the test name should not exceed 10 characters.
Otherwise, warning messages will appear.
Unit
Unit of the result. Select from the drop-down list. The options
include g/L, mmol/L, umol/L, U/L, mg/dL, IU/L, mg/L and void. The
default is void. The units can be added and deleted in Setup.
Precision
Precision of the result. Select from the drop-down list 1, 0.1, 0.01,
0.001. The default is 1.
Default
reference
By Diff.
4-10
Parameter
Description
Edit
formula
Function
Add
Delete
Save
Cancel
After selecting a test and setting or modifying parameters for it, click
this button to cancel the setting or modification.
Return
2.
A/G= ALBalbumin/GLBglobin
3.
4.
5.
ApoA1/ApoB
ratio
apolipoprotein A/apolipoprotein B
4-11
4.2.4 Off-system
All the tests that are not run by the analyzer are referred to as the off-system tests.
You can manually enter the off-system test results in to the system to print out them
in the patient report. For newly added off-system test, it is printed after the routine
tests. You can readjust the printing order in Setup.
Figure 4-9 Off-system
Description
Test
The test name should be set and same test names are not allowed.
The length of the test name should not exceed 10 characters.
Otherwise, warning messages will appear.
Unit
Unit of the result. Select from the drop-down list. The options
include g/L, mmol/L, umol/L, U/L, mg/dL, IU/L, mg/L and void. The
default is void. The units can be added and deleted in Setup.
Precision
Precision of the result. Select from the drop-down list 1, 0.1, 0.01,
0.001.The default is 1.
Default
reference
By Diff.
Function
Add
Delete
Save
4-12
4.3
Buttons
Function
Cancel
After selecting a test and setting or modifying parameters for it, click
this button to cancel the setting or modification.
Return
Test
Click Test on the main screen to enter the test screen. The Test screen is divided
into three parts: Request, Test and Result. You can run test directly, or run after
requesting. The sample ID will automatically increase according to the testing order,
if requesting is used.
4.3.1 Request
Before testing, you can enter all the samples and the tests into the system. After
entering the Test screen. The tests will be marked with *. The sample ID will
automatically increase according to the testing order.
The following shows an example:
001ALTASTTPALB
002ALTASTGLU
003TPALB
004ALTGLU
The test list shows tests which have been requested but not yet run. These tests are
marked with *. If you select ALT, during test, the first sample ID is 001, the second
002 and the third sample ID will increase automatically to 004.
The requesting status of samples is shown in the list on the left side of the screen;
tests are shown in the list in the middle of the screen; profiles are shown in the list on
the right side of the screen.
In Request screen:
After selecting or entering a sample ID, select the tests in the test list. If you are to
select a profile, select it in the profile list. Click Save. The requested sample will be
shown in the list on the left side of the screen.
Select a sample ID in the left list to view the tests requested on this sample.
4-13
Description
Sample ID
Patient
Tests
Profiles
Function
Save
Delete
Cancel
4-14
Buttons
Function
View
Return
4.3.2 Test
Click Test on the main screen to enter the test screen.
Figure 4-11 Test
4-15
Description
Tests
A list of all the on-board tests. The requested test is marked with
*.
Parameter
System status
area
Instrument status and information during test is shown in this
area.
When system is normal, the area shows Standby
When sample or other solution to be tested is selected, the area
shows: Please aspirate.
When system fails, the area shows: error!
When temperature is not
Temperature stabilizing
stabilized,
the
area
shows:
4-16
Parameter
Description
Wash
Stop
Water Blank
Rgt. Blank
Sample Blank
Sample
When the system running distilled water zero, the ABS of water
blank is displayed
When the system running reagent blank, the ABS of reagent
blank is displayed.
4-17
Parameter
Description
Conc.
Realtime
ABS
During test, this area shows the real-time ABS. When test is
completed, this area shows the response of the current sample.
Function
QC
record
Click this button to view the QC result of the selected test. Please refer
to 4.5 for more details.
Cal
record
Print
curve
Curve
Data
Click this button to view the reaction curve points of all the periods.
Start
Click this button to aspirate and run test. The button can be used as a
substitute for Aspirate button.
Return
4-18
Select test
Water blank
Reagent blank
Calibrator
Sample blank
(Sample)
Yes
Control
NOTE
During test, if the cuvettes are contaminated, the test result might not
be reliable. We recommend you to wash the cuvette using ethanol
solution (the volume ratio of ethanol and water is 4:1) or wash
solutions specific for cuvette. For more details, please refer to 5.3.1.1
Low Background
Soaking the cuvettes in ethanol or other wash solutions is forbidden.
4.4
Calibration
You can view calibration curve, calibration parameters and edit the linear calibration
parameters in the Calibration screen.
4-19
Parameter
Description
Test
Date
Rule
Calibration rule.
4-20
Parameter
Description
No.
Std. Conc.
Response
Parameter
Value
Function
Edit
NOTE
The formula can only be edited when the calibration
rule is linear calibration (single-point, two-point and
multi-point).
4-21
Buttons
Function
Return
CAUTION
The replacement of certain components should be followed with
calibration. Otherwise, you may get unreliable result.
4.5
QC
You can view the QC result and QC reaction curve, and check whether the test is out
of control and print QC reaction curve in the QC screen.
Figure 4-14 QC
Description
Test
Date
Control
Lot No.
The latest 5 lot No. will be displayed. The default is the most
recent lot No..
SD
AVG
4-22
Parameter
Description
C1, C2, C3
No.
Date
Concentration
QC result
Remark
Query
Inquire the QC curve and the result of the selected test and
control within the specified time range.
4.6
Buttons
Function
Delete
Upload
Click this button to send the control result of the selected test to LIS.
Return
Result
You can inquire, edit, modify and printer the patient report.
4-23
4.6.1 Result
4.6.1.1 View Results by Sample
Figure 4-15 View Results by Sample
Select Sample to display the result by sample; select Test to display the result by
test. The result of the current day will be displayed by default. It there is no test result
for the current day. No data will be displayed.
The following table explains the parameters on the screen.
Parameter
Description
Test
Name of the test. Select a test to view all the test result of the
current day in the list on the right side of the screen.
Patient
Name of patient.
Sample ID
Unit
Test Date
Reference
Original
Original result of the test. If the result is edited, the original result is
kept for checking up.
Remark
All
4-24
Buttons
Query
Function
Click Query to pop up the following page.
Edit
Select one sample to a sample result to enter the Edit page or enter
the page directly.
The editing function will be elaborated separately in the following.
Delete
Delete all the result of the selected test, when it is displayed by test.
Delete all the result of the selected sample, when it is displayed by
sample.
Upload
Return
4-25
Function
Click Query to pop up the following page.
4-26
Buttons
Summary
Function
Click Summary to pop up the following page.
Select Test (including all the on-board tests and defined off-system
tests) and time range to search for results that meet the
requirement.
Print
Return
4.6.2 Edit
Click Edit or Add in Result window to enter the screen to edit the result report.
When you enter the screen by clicking Edit, the sample ID can not be edited; when
you enter the screen by clicking Add, the sample ID can be edited.
The screen is divided into two parts: one part is for information of the test report,
including patient information and doctor information; the other part is for test result
information, where you can add, delete or edit the test results.
4-27
Description
Test
Conc.
Test result.
Unit
Reference
Response
Original
Original result of the test. If the result is edited, the original result is
kept for checking up.
Remark
4-28
Function
Add
Select the test name (including routine test and calculation test in
the Routine drop-down list box. Enter the Quantitative and/or flag
result in the Result area.
Select test name for off-system test, enter the test result in Result
area.
Off-system tests and
Setup-Dictionary.
Edit
flags
can
be
added
or
deleted
in
After selecting a test result, click Edit to pop up the following screen.
Description
Name
Name of patient.
4-29
Parameter
Description
Sample ID
Type
The options are serum, plasma and urea, etc. You can add or delete
the types in Setup-Dictionary.
Age
Gender
MRN
Sender
Name of the doctor who sent the sample to the clinical laboratory.
You can add or delete the names in Setup-Dictionary.
Tester
Name of the doctor who tested the sample. You can add or delete the
names in Setup-Dictionary.
Test Date
Send Date
Reviewed
by
Name of the doctor who reviewed the test report. You can add or
delete the names in Setup-Dictionary.
Remark
Function
Click this button to view or edit the information of last sample.
Click this button to view or edit the information of the next sample.
4.7
Save
Cancel
Cancel all the editing and return to the status before editing.
Return
Setup
You can set hospital name, system date and time, data dictionary, touchscreen
calibration and delete history data in Setup.
4-30
4.7.1 Basic
Figure 4-19 Basic setup of the system information
Description
FPGA
Software
Hospital
Start button
sound
Pump
speed
Date
and
Time
Standby
interval
Set the time interval for the system to enter Standby status.
Colorimetri
c mode
4-31
NOTE
Sound alarming is available on the system. If the sound of pressing a
button is shut off, the sound alarming function will be disabled, then
you should observe the prompt information for any alarming.
Function
Touchscr. Cal
Save
Return
4.7.2 Dictionary
The Dictionary screen contains three parts: the list on the left side of the screen
shows the dictionary items; the list on the top right side shows the detailed
information of the selected item; the text box and the buttons below the detailed
information list are used to add, delete and save new information for the selected
dictionary item.
4-32
Description
Unit
Type
Sender
Add, delete the name of the doctor who sends the sample.
Tester
Add, delete the name of the doctor who tests the sample.
Reviewer
Add, delete the name of the doctor who reviews the sample result.
Qualitative
result
Function
Add
Delete
Cancel
Save
Return
4-33
The following table explains the parameters on the Print Features screen.
Parameter
Description
Internal
Printer
External
Printer
Select external printer to print test result. The Appendix lists the
printers the system supports.
Start
internal
online PRN
Function
Top
Up
Down
Bottom
Cancel
Return
4.7.4 Carryover
In Carryover screen, you can set some tests between which carryover may exists to
notify operators to rinse the tubes, thus the effect brought about by carryover can be
minimized.
4-34
Select contaminating test in the Contaminating test list; select contaminated test in
the Contaminated test list. Select Save to save the setting.
Enter specified information in LIS manufacture and LIS. Set the Index of Test
config., Result Setup, Unit and Type, according to the index No. provided by LIS.
The operation is as follows: Select Test config. and the list on the left side of the
screen shows all the test names on the system. Select one test and enter the index
on the LIS into the Index beside the test name.
After setting is completed, click Save to return to the main screen.
4-35
Enter the right information in LIS manufacturer and LIS text box. Set the Index for
test, quantitative result, qualitative result, unit, sample type in consistent with those
provided by LIS. The index number will be the unique symbol recognized by LIS,
facilitating the communication between the analyzer and the LIS. If the wrong index
number is set, the result can not be correctly uploaded.
The detailed operation is as follows: select Test config., the list on the right of the
screen will list the names of all the routine and calculation tests. Select one test,
enter its index number in Index column. Click save to complete the setting.
When the system is connected with data management software, In Instrument
reg.Channel No. setup, the channel No. of fields like test information, sample
type should be consistent with SystemLIS setup in BA-88A, otherwise, the
information can not be uploaded correctly.
After all the settings are complete, click Save to return to the main screen.
4.8
Maintenance
You can do maintenance on the database or the instrument; manage the system log
on Maintenance screen.
NOTE
While doing maintenance, only use the component provided by
Mindray customer service department or your local distributor.
4.8.1 Database
On Database screen, you can check the maximum capacity for storing the test
results and the remaining capacity. Deleting history data to release space can also
be done on this screen. If maximum capacity is reached, new test result will replace
the history result automatically.
Select DB backup to transfer the test information and test result on the analyzer to
USB disk.
4-36
4.8.2 Log
You can view failure records on this screen.
Figure 4-25 Log
Error list is on the left side of the Log screen. On the right side of the screen, detailed
information about the selected item is shown, including Error Info., Causes and
Corrective, which can be used as reference while troubleshooting the failures.
4-37
4.8.3 Maintenance
In this screen, you can conduct maintenance by selecting Pump cal and Gain
adjust. The Password function is only available to service personnel and authorized
distributors.
Figure 4-26 Maintenance
Pump Cal can facilitate the calibration of peristaltic pump. The detailed procedures
are as follows: Prepare 6000l distilled water, select 1st, and then click Start. The
4-38
system will start to aspirate distilled water. When all the water has been aspirated,
click Stop. Follow the procedure above to finish the 2nd and 3rd calibration.
NOTE
The error of the volume 6000 l should be as small as possible.
As soon as all the distilled water is aspirated, the Stop should be
clicked, otherwise the calibration might not be precise.
After replacing the lamp, cuvette, filter or when alarm messages like Light signal too
weak, Light signal too strong appears, the Gain adjust can be used to adjust the
light intensity to proper degree.
The detailed operation is as follows: prepare distilled water, click Start-Aspirate.
Save the new gain coefficient after adjustment.
4.8.4 Shutdown
Click Shutdown on the main screen. Please follow the instructions displayed on the
screen to wash the tubes with distilled water and then shutdown the power.
CAUTION
After powering off, do not power on immediately. Wait at least 10
seconds, if powering on is required.
4-39
Maintenance
WARNING
Do not perform any maintenance procedures that are not described
in this chapter. Otherwise, it may lead to personnel injury or
equipment damage.
Do not touch the parts other than specified.
Performing unauthorized maintenance procedures may damage
your system, void any applicable warranty or service contract and
even cause personal injury.
Do not spill water or reagent on mechanical or electrical
components of the system.
BIOHARZARD
Wear gloves and lab coat and, if necessary, goggles during
maintaining process.
Before maintenance or packaging for transportation, the used
instrument should be disinfected to ensure personal safety.
5.1
Daily Maintenance
1 Use neutral wash solution and wet cloth to remove the spillage on the
instrument.
2 Wash the tubing with distilled water or DI water before shutting down the
analyzer (for instrument installed with flow cell).
5-1
3 When the system is not in use, make sure that the tubing and the flow cell is
filled with clean distilled water (or DI water).
5.2
Weekly Maintenance
1 Wash the waste bottle interior with clean water. Soak the bottle with
disinfector if necessary.
2 If the instrument will not be in use for a long time. Detach the pump head
from the pump to elongate the service life of the pump tubing.
5.3
Irregular Maintenance
Click Wash on the software to wash the tubing. After 5 seconds, click Stop.
2)
Prepare about 5 ml ethanol solution in the tube. Put the aspiration tubing into
the tube and click Wash. After 5 seconds, click Stop. Wait for 10 seconds.
3)
Wash with ethanol solution for 5 seconds again, and then wait for 10 seconds.
Wash the tubing with DI water for 10-20 seconds. The cleaning is completed.
4)
Other recommended wash solutions include: 0.1N NaOH (KOH) solution (with
some surfactant); or, enzyme solution capable of decomposing the protein; or,
reagent used in chemistry analysis, capable of removing the protein, total
protein reagent (biuret) and etc.
5-2
WARNING
Some reagents are corrosive. Exercise caution when handling the
reagents.
In case the reagents or wash solution spill into your eyes,
rinse them with much water and consult an oculist.
NOTE
The lamp must be replaced when its light intensity attenuates to the
specified threshold. When the range of background preset by the
system can not be restored by adjusting the photoelectric gain, it might
be possible that the light intensity attenuates to the specified threshold
and the lamp should be replaced timely.
Shutdown the instrument and disconnect the power cable between the
instrument and the power supply.
5-3
Locate the position where the peristaltic pump is installed. Pull out the tubing
that goes through the backboard of the analyzer for 40-50mm until the adapter
is exposed. Pinch the two buckles on the left and right side of the pump shell
and detach the pump head carefully.
Pull
the
tubing
out
slightly
Pinch
the
buckles
to
detach
the
pump head
After detaching the pump head, unplug the tubing (yellow) whose adapters are
closer to the pump head.
Unplug the
tubing
(yellow)
whose
adapters
are closer
to the pump
head.
5-4
After unplugging the adapters, pinch the buckles on the pump head and detach
the pump shell.
Pinch
the
buckles
on
the
pump
head
and
detach
the
pump shell.
After detaching the pump shell, press the roller inside the pump to take the
used pump tubing out. Remove the red ring on the used tubing and install them
on the new tubing. Install the new pump tubing on the pump and carefully pull it
to make the tubing fit well with the inside of the pump without any twisting.
Make sure the lengths exposed at both ends are roughly the same. If
necessary, pull both ends of the tubing slightly.
5-5
After mounting the pump shell, install the pump head on the pump.
Install the pump
head on the pump,
with the motor
shaft
into
the
installation hole
Pinch
the
buckles to lock
the pump head
After installing the pump head, connect the tubing with the tubing that goes
through the backboard and the waste tubing. The pump tubing on the left
should be connected to the tubing that goes through the backboard, the pump
tubing on the right to the waste tubing.
The pump tubing on
the left should be
connected to the
tubing that goes
through
the
backboard.
After connecting the tubing, slip the tubing that goes through the backboard
into the analyzer until the adapters does not expose to the outside.
Check the installation for any errors. Connect the analyzer to the power supply
and calibrate the pump. Please refer to the relevant part of the operators
manual for calibration method.
BIOHARZARD
When replacing the pump tubing, wear gloves and lab coat and, if
necessary, goggles. In case your skin contacts the waste, follow
standard laboratory safety procedure and consult a doctor.
5-6
NOTE
The service life of the pump tubing is 18 month. Tubing should be
checked irregularly and replaced in time.
Do not use excessive force while pulling, slipping the tubing or doing
any operation that might pulling the tubing. Otherwise, the tubing
might be damaged or the inner connection might be cut off.
While connecting the tubing, insert the tubing into the adapter until the
tubing reaches the bottom of the adapter so as to ensure the reliability
of the connection.
While installing the pump tubing into the pump, avoid twisting. If
necessary, pull the tubing back and forth slightly.
Calibrate the pump after replacing the pump tubing. Otherwise, the
aspiration volume might not be correct and the test may be affected.
Open the optical window cover and press the bottom of the flow cell ( if flow
cell fastening screw is installed, you do not have to press), then carefully pull
the metal inlet tubing which is connected with the flow cell ( the slimmer one
which is closer to the front of the instrument)
Pull the
tubing
out
5-7
Connect the thicker end of the new tube to the inlet metal tube and then guide
the tube through the deflection tube.
The
thicker
end
is
connected
with the metal
tube
Aspiration
deflection
tube
BIOHAZARD
When replacing the pump tubing, wear gloves and lab coat and, if
necessary, goggles. In case your skin contacts the waste, follow
standard laboratory safety procedure and consult a doctor.
NOTE
After replacement is completed, please make sure that the flow cell is
pressed to the bottom of the installation hole (the top of the flow cell
should be on the same level with the installation surface). Otherwise
the test result might not be reliable.
NOTE
When connecting the tube, the tube should reach the root of the metal
tube to ensure reliability.
After the aspiration tubing is installed, the bending part should be
transitioned smoothly, no sharp angle, corrugation is allowed
5-8
Open the optical window cover, use cross screw driver to unscrew the screws
on the lamp replacement window cover. Remove the cover.
Unscrew
the
two
screws
and
remove
the
replacement
window cover
Unscrew the fastening screw of the lamp base (if it is difficult to dismount,
some tools like the clipper might be used). Put the screws in a proper place
outside the instrument. Pinch the lamp base directing line and then carefully
take the lamp assembly out).
Lamp
base
fastening
screw
Lamp
base
directing
line
5-9
Pull the wire out and you can see the wire joint connecting the lamp assembly,
with one end connecting to the lamp and the other end connecting to the inside
of the instrument. Pinch both ends of the joint and press the buckle to
disconnect the joint. The dismounting is completed.
Wire
joint
Connect the new lamp with the wire joint of the lamp assembly and wire joint in
the instrument. Install the lamp into the installing hole in the lamp base. Fasten
the retaining screw on the lamp base.
After installation, power on the instrument. Adjust the gain. Check the
background after the instrument is stabilized to check whether the replacement
is successful.
WARNING
If you want to replace the 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.
NOTE
When replacing the lamp assembly, do not touch the surface of the
bulb.
When dismounting the restraining screw of the lamp base, please take
extra care to avoid element falling into the inside of the instrument. If it
is difficult to dismount, some tools like the clipper might be used. The
photoelectric gain should be adjusted after the lamp is replaced. For
more details, please refer to 5.3.2 Adjusting the Photoelectric Gain.
5-10
Calculating Calibration
Parameters and QC Rule
The system provides two calibration methods: linear calibration and nonlinear
calibration. Linear calibration includes one-point linear calibration, two-point linear
calibration and multi-point linear calibration. They are mainly used for tests
determined by colorimetry. Nonlinear calibration includes Logit-Log 4P, Logit-Log 5P,
Exponential 5P, Polynomial 5P, Parabola and Spline. They are mainly used for tests
determined by turbidity.
In this section,
R - calibrator response
C - calibrator concentration (activity)
K , R 0, a , b , c - calibration parameters
6.1
6-1
R
.
C
a=
R R1
R2 R1
, b = R1 2
C1 .
C 2 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.
a=
C R
i =1
i =1
C
i =1
( C i )( Ri ) / n
2
i
i =1
( C i ) 2 / n
i =1
6.2 Calculating
Parameters
Nonlinear
Calibration
Logistic-Log 4P
Calibration formula: R = R0 + K
1
1 + exp[(a + b ln C )]
6-2
C1
C2
C3
C4
Logistic-Log 5P
Calibration formula: R = R0 + K
1
1 + exp[(a + b ln C + cC )]
Exponential 5P
Calibration formula:
R0 , K , a , b and c .
This calibration method requires at least five calibrators. The concentration (or
activity) of calibrator 1 is 0, and the corresponding R is equal to R0 0.This
calibration method is applied to the calibration curve that the response increases
sharply when the concentration reaches a specific value. See Figure 6-2.
Figure 6-2 Exponential 5p calibration curve
C1 C2
C3
C4
C5
Polynomial 5P
Calibration formula: ln C = a + b(
R R0
R R0 2
R R0 3
) + c(
) + d(
)
100
100
100
6-3
R0 , a , b , c and d .
This calibration method requires at least five calibrators. The concentration (or
activity) of calibrator 1 is 0, and the corresponding R is equal to R0 .
Parabola
Calibration formula: R = aC + bC + c
2
Spline
Calibration formula: R = R0i + a i (C C i ) + bi (C C i ) + ci (C C i )
2
ci .
6.3
Calculating Concentration
C=
R
a
Where,
a - calibration parameter
C=
Rb
a
Where,
a , b - calibration parameters
6-4
C=
Rb
a
Where,
a , b - calibration parameters
Logistic-Log 4P
a ln(
C = EXP(
K
1)
R R0
)
b
Where,
R0 , K , a , b
- calibration parameters
Logistic-Log 5P
The positive real root is obtained with the dichotomy method.
Exponential5P
The positive real root is obtained with the dichotomy method.
Polynomial5P
C = exp(a + b(
R R0
R R0 2
R R0 3
) + c(
) + d(
) )
100
100
100
Where,
R0 , a , b , c , d - calibration parameters
Parabola
The positive real root of the following linear quadratic equation is obtained:
aC 2 + bC + c R = 0
6-5
Spline
Spline defines several calculation sections based on the responses of calibration
concentrations. Each section differs in specific parameters. Therefore, the section to
which the current response belongs should be confirmed before Spline calculation.
The parameters of relevant section shall be used to obtain a positive real root with
the dichotomy method.
6.4
QC Rule
Explanation
QC
Conclusion
12S
Warning
13S
Out-of-control
(random
error,
systematic
error)
22S
Two
consecutive
control values for one
level
exceed
2
standard deviations.
Out-of-control
(systematic
error)
R4S
The
difference
between
two
consecutive control
values exceeds 4
standard deviations.
Out-of-control
(random
error)
41S
Four
consecutive
control values for one
level
exceed
1
standard deviation.
Out-of-control
(systematic
error)
10X
Ten
consecutive
control values for one
level lie on one side
of the mean.
Out-of-control
(systematic
error)
Westgard multi-rule QC conclusion flow for single control is shown in Figure 6-3.
6-6
For several controls, the conclusion logic is similar to the above condition, except for
multiple continuous QC data, which should be combined simultaneously.
6-7
Appendix A Specifications
A.1
Technical Specifications
A.2
Power Requirements
A.3
Environment Requirements
A.3.1
Working Environment
Temperature: 15C30C;
A.4
Dimension: 420mm350mm158mmWDH
Weight: 7kg
A-1
A.5
Input/Output Devices
Touchscreen
Popup keyboard
Recorder
A.6
Interface
USB port: interface between the analyzer and the mouse, keyboard or portable
storage device.
A.7
Safety Classification
Overvoltage type: II
Pollution level: 2
A-2
Code
Causes
Calibration
monotone
checking error
MON
Calculation
failed
COV
Recalibrate
010
Absorbance
exceeds
the
limit
ABS
Reagent blank
out of range
RBK
No
Interval
NLN
Out of linear
range
(non-linear)
LIN
Above Linearity
High
>
Calculated
concentration
exceeds high limit of linearity
range
Above Linearity
Low
<
Calculated
concentration
exceeds low limit of linearity
range
Calculation error
for calculation
test
CIE
Concentration
calculate error
CCE
Linear
B-1
ADL
Dark current is
too high
DRH
001
Cuvette
temperature too
high
002
Cuvette
temperature too
low
003
Cuvette
temperature
fluctuation out
of range
004
Fan
blocked
during running
005
Fan blocked or damaged
Temperature
switching
exceeds
time
limit
006
Sensor
abnormal
007
008
009
Photoelectric
collection
is
abnormal
010
B-2
011
012
Circuit error
Photoelectric
error
gain
B-3
adjusting
HP DeskJet 5652
HP DeskJet 3820
HP DeskJet 5438
HP DeskJet 3668
HP DeskJet D2368
HP Photosmart D5168
HP Business InkJet 1000
C-1
Appendix D 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.
Part Name
Part Number
Location
Description
Lamp assembly
BA89-30-86998
Lamp base
Regularly-replace
d part
Flow cell
M90-000168---
Cuvette
installation
hole inside the
optical window
Replace it when
damaged
BA89-30-87035
Internal printer
component
Replace it when
damaged
Pump tubing
M6G-020052---
Peristaltic
pump
Replace it when
damaged
Aspiration
BA89-30-87070
Above
the
Aspirate button
Replace it when
damaged
A30-000001---
Internal printer
Consumable
Internal
assembly
Thermal
paper
printer
printing
D-1
P/N: BA89-20-87038(1.0)