CXL PRO 240 Test-Hr User Manual - Compressed

AUTO-CHEMISTRY ANALYZER
The User Manual is applicable to Auto-Chemistry Analyzer (model: MISPA CXL PRO) (hereinafter referred
to as the Analyzer).
Explanation
Dear customers, thanks for purchasing our Auto-Chemistry Analyzer (model: MISPA CXL PRO).
Please read the manual carefully before operation as incorrect operation may affect the accuracy and precision of
test results and even cause the damages of the Analyzer or personal injury.
After reading, please reserve the manual properly for reference at any time.
Manufacturer: AGAPPE
Global Access Point:-
Agappe Diagnostics Switzerland GmbH,

Knonauerstrasse 54 – 6330,
Cham, Switzerland
Tel:- +41 41 780 60 10 | Fax:- +41 41 780 60 11
Corporate Office (Asia Pacific Office):-
Agappe Diagnostics Ltd,

Agappe Hills, Kochi, Kerala 683562, India
Tel:- +91 484 287 7000 | Fax:- +91 484 286 7222
Website: www.agappeswiss.com
Mail: info@agappeswiss.com | marketing@agappeswiss.com | service@agappeswiss.com
Date of Production: See the label.
Service Life: 7 years
Date of Compilation/ Revision: 04-2018.

Attentions
● The Analyzer shall be used by professional medical examination personnel or trained doctors, nurses and testers.
● As the Analyzer has biological and chemical risks, the operator shall be trained and use personal protective
appliance to reduce the risk.
● Only trained operators are allowed to conduct dangerous operations, such as moving parts.
● The Analyzer shall be controlled with a special software designated by the company. Installation of other software
or hardware on the computer may affect the normal operation of the Analyzer. Please do not operate other software
during the operation of the Analyzer.
● As the Analyzer may have dust accumulated on its surface during its long-term storage, its surface shall be cleaned
with a clean soft cloth or gauze gently and a small amount of detergent can be used if necessary. Please cut off the
power supply first before the cleaning of the Analyzer. Please close the upper cover of the Analyzer when the Analyzer
is not operated.
● Please do not wipe the surface of the Analyzer with any organic solvent.
● For the usage and storage of relevant samples, reagent, QC solution and standard solution, please refer to their
manuals.
● The operator is obligated to follow national and local regulations on discharge and treatment of expired reagent,
waste liquid, waste sample and consumables. Please treat the waste liquid and the consumables of the Analyzer
according to regulations about medical waste, infectious waste and industrial waste.
● Local printer shall be used to print the reports and charts.
● In introduction about the application software of the Analyzer in the user manual, many chemical parameters are
taken as example but of no actual test meaning. Please refer to the reagent instructions for chemical parameters.
● Under an environment with low transportation or storage temperature or relative humidity greater than 85%, the
Analyzer shall be turned on for testing only after it is stored in a normal working environment for 24 hours.
Warning
● The protection measures provided for the Analyzer may become invalid if the Analyzer is not used according to
the manual.
● The Analyzer shall be used under a well-grounded condition, independent power supply shall be used and the
input voltage shall meet the requirements of the Analyzer.
● Do not pull or insert the plug with wet hands as it may cause electric shock.
● Do not tread on, warp or pull the wires and cables as they may break and cause a fire.
● Before the master power supply for the Analyzer is cut off, no personnel except from the professional
maintenance personnel of the company are allowed to open the rear cover plate and side cover plate.
● If any liquids enter the Analyzer or the internal pipeline has liquid leakage, please turn off the master power
supply for the Analyzer immediately and contact the customer service personnel of the company in a timely manner.
● Please do not touch the moving components such as probe and mixing bar when the Analyzer is operating. Please
do not put your hands in an open component as it may cause personal injury or damages of the Analyzer.
● When changing the light source lamp, the power supply for the Analyzer shall be cut off first and then wait for the
cooling of light source lamp. Do not touch the light source lamp before the lamp is cooled to prevent burn.
● The Analyzer shall be regularly maintained in strict accordance with the manual, or the Analyzer may have faults
or its test precision and accuracy of the Analyzer may be affected.
● Please use the Analyzer under conditions regulated in the manual. If not, the Analyzer may not operate normally,
the test results may not be reliable, the components of the Analyzer may be damaged and personal injuries may be
caused.
● Please do not use combustible goods around the Analyzer.

Statement
AGAPPE Company has the final interpretation right of the manual.
AGAPPE Company declares that it will be responsible for the safety, reliability and performances of the Analyzer
only if all following requirements are met.
(1) The installation, commissioning and repair of the Analyzer are undertaken by professional personnel of the
company.
(2) Relevant electrical equipment complies with national standards.
(3) The Analyzer is operated according to the manual.
No further notice will be provided in case of any changes to the software interface.
User Manual
Contents
Chapter 1 Brief introduction ......................................................................................................... 1-1

1.1 Overview ......................................................................................................................................................... 1-1
1.2 Major indicators ............................................................................................................................................. 1-1
1.3 Composition of the Analyzer ......................................................................................................................... 1-3
1.3.1 Appearance of the Analyzer .............................................................................................................................................. 1-3
1.3.2 System composition of the Analyzer ................................................................................................................................. 1-6
1.4 Structure and functions of the Analyzer ...................................................................................................... 1-6

1.4.1 Operation unit ................................................................................................................................................................... 1-6
1.4.2 Analyzing module ............................................................................................................................................................. 1-6
1.5 Symbols.......................................................................................................................................................... 1-13

1.6 Signs ............................................................................................................................................................... 1-14
1.7 Working principle of the Analyzer ............................................................................................................. 1-15
1.7.1 Operating positions of mechanisms ................................................................................................................................. 1-15
1.7.2 Analysis flow chart ..........................................................................................................................................................1-16
1.7.3 Photometric characteristics...............................................................................................................................................1-16
Chapter 2 Installation of the Analyzer.......................................................................................... 2-1

2.1 Installation requirements............................................................................................................................... 2-1
2.1.1 Space requirements ........................................................................................................................................................... 2-1
2.1.2 Environmental requirements ............................................................................................................................................. 2-1
2.1.3 Power requirements ........................................................................................................................................................... 2-2
2.1.4 Requirements for pure water ............................................................................................................................................. 2-2
2.2 Unpacking. ...................................................................................................................................................... 2-2

2.2.1 Unpacking steps ................................................................................................................................................................ 2-2
2.2.2 Way of carrying ................................................................................................................................................................ 2-2
2.3 Installation process ......................................................................................................................................... 2-3

2.3.1 Installation of the Analyzer ............................................................................................................................................... 2-3
2.3.2 Power connection .............................................................................................................................................................. 2-7
2.3.3 Connection of peripheral equipment ................................................................................................................................. 2-7
2.3.4 Software installation and uninstallation............................................................................................................................. 2-7
2.3.5 Pure water filling ............................................................................................................................................................. 2-11
2.3.6 Discharge of waste liquid .................................................................................................................................................2-12
2.3.7 System login .....................................................................................................................................................................2-12
2.3.8 Commissioning of the Analyzer ...................................................................................................................................... 2-15
2.3.9 Test of clinical items ........................................................................................................................................................2-15
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2.3.10 Training for medical personnel ..................................................................................................................................... 2-15
2.3.11 Fill-in of installation acceptance report ......................................................................................................................... 2-15
2.4 Barcode reader of the sample reagent disk ................................................................................................ 2-15

2.4.1 Scanning range of barcode reader ................................................................................................................................... 2-15
2.4.2 Requirements for sample container ................................................................................................................................. 2-15
2.4.3 Requirements of reagent bottle........................................................................................................................................ 2-16
2.4.4 Requirements for sample barcodes use ........................................................................................................................... 2-16
2.4.5 Requirements for reagent barcodes use ........................................................................................................................... 2-16
2.4.6 Requirements for pasting barcode labels ......................................................................................................................... 2-16
2.4.7 Use of barcode reader ......................................................................................................................................................2-17
2.4.8 Rule of reagent barcodes ..................................................................................................................................................2-17
Chapter 3 Software operation ....................................................................................................... 3-1

3.1 Software interface description ....................................................................................................................... 3-1
3.1.1 Window composition ........................................................................................................................................................ 3-1
3.1.2 Keyboard function............................................................................................................................................................. 3-3
3.1.3 List of software function keys ........................................................................................................................................... 3-3
3.2 How to operate software ................................................................................................................................ 3-4

3.2.1 Cursor movement .............................................................................................................................................................. 3-4
3.2.2 Key selection ..................................................................................................................................................................... 3-4
3.2.3 Window opening ............................................................................................................................................................... 3-5
3.2.4 Operation of list box and scroll bar ................................................................................................................................... 3-6
3.2.5 Operation of pull-down menu. .......................................................................................................................................... 3-6
3.2.6 Option button and check box............................................................................................................................................. 3-6
3.2.7 Grid table width adjustment .............................................................................................................................................. 3-7
Chapter 4 System management ..................................................................................................... 4-1

4.1 Information management .............................................................................................................................. 4-1
4.1.1 User information ............................................................................................................................................................... 4-1
4.1.2 Hospital information ......................................................................................................................................................... 4-2
4.1.3 Other information .............................................................................................................................................................. 4-4
4.2 System log........................................................................................................................................................ 4-7
Chapter 5 System setting ................................................................................................................ 5-1

5.1 Item maintenance ........................................................................................................................................... 5-1
5.1.1 Addition of colorimetric item ............................................................................................................................................ 5-2
5.1.2 Modification of serum index ............................................................................................................................................. 5-2
5.1.3 Modification of ion item ................................................................................................................................................... 5-2
5.1.4 Addition of manual item ................................................................................................................................................... 5-3
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5.1.5 Print sequence ................................................................................................................................................................... 5-3
5.2 Item parameters ............................................................................................................................................. 5-3

5.2.1 Analysis parameters of colorimetric item.......................................................................................................................... 5-3
5.2.2 Calibration parameters of colorimetric item .................................................................................................................... 5-15
5.2.3 Range parameters of colorimetric item............................................................................................................................ 5-27
5.2.4 Manual item parameters ...................................................................................................................................................5-28
5.2.5 Parameters of ionic item ...................................................................................................................................................5-29
5.3 Serum information ....................................................................................................................................... 5-30

5.4 Item combination .......................................................................................................................................... 5-32
5.5 Calculation and compensation item ............................................................................................................ 5-33
5.5.1 Calculation item ...............................................................................................................................................................5-33
5.5.2 Compensation item...........................................................................................................................................................5-34
5.6 Cross contamination..................................................................................................................................... 5-34

5.6.1 Cross contamination of probe.......................................................................................................................................... 5-35
5.6.2 Cuvette cross contamination ............................................................................................................................................5-36
5.7 Report format ............................................................................................................................................... 5-37

5.8 Other information ........................................................................................................................................ 5-38
5.9 LIS communication ...................................................................................................................................... 5-39
Chapter 6 Calibration Information............................................................................................... 6-1

6.1 Colorimetric calibration................................................................................................................................. 6-1
6.1.1 Register colorimetric item calibration ............................................................................................................................... 6-1
6.1.2 Calibration result of colorimetric item .............................................................................................................................. 6-2
6.2 ISE calibration ................................................................................................................................................ 6-7

6.2.1 Register ISE item calibration ............................................................................................................................................ 6-7
6.2.2 Calibration result of ISE item ............................................................................................................................................ 6-8
6.2.3 Measurement principle of electrolyte ................................................................................................................................ 6-8
Chapter 7 QC Management ........................................................................................................... 7-1

7.1 QC registration ............................................................................................................................................... 7-1
7.1.1 Set QC rules ...................................................................................................................................................................... 7-2
7.1.2 Add QC parameter ............................................................................................................................................................ 7-3
7.1.3 Modify QC parameter ....................................................................................................................................................... 7-4
7.1.4 Delete QC item.................................................................................................................................................................. 7-4
7.1.5 Set QC position ................................................................................................................................................................. 7-4
7.1.6 QC test 7-4
7.2 Daily QC data ................................................................................................................................................. 7-5

7.3 Monthly QC .................................................................................................................................................... 7-7
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Chapter 8 Operation of the Analyzer ........................................................................................... 8-1

8.1 Operation overview ........................................................................................................................................ 8-1
8.2 Detailed operation .......................................................................................................................................... 8-2
8.2.1 Check before test ............................................................................................................................................................... 8-2
8.2.2 Connect power cable and log in the software .................................................................................................................... 8-2
8.2.3 Confirm the state of the Analyzer ..................................................................................................................................... 8-2
8.2.4 Confirm analysis conditions .............................................................................................................................................. 8-5
8.2.5 Prepare reagent (reagent information) ............................................................................................................................... 8-7
8.2.6 Registration of calibration item and QC item ...................................................................................................................8-16
8.2.7 Sample registration...........................................................................................................................................................8-16
8.2.8 Prepare test .......................................................................................................................................................................8-21
8.2.9 During test ........................................................................................................................................................................8-22
8.2.10 Confirm test results ........................................................................................................................................................8-27
8.2.11 Recheck of sample .........................................................................................................................................................8-45
8.2.12 Analysis ended ...............................................................................................................................................................8-48
Chapter 9 System Help ................................................................................................................... 9-1

9.1 Use of system help........................................................................................................................................... 9-1
Chapter 10 System Maintenance ................................................................................................. 10-1

10.1 Preparation before system maintenance .................................................................................................. 10-1
10.1.1 Tools and instruments ....................................................................................................................................................10-1
10.1.2 Pure water ......................................................................................................................................................................10-1
10.1.3 Detergent ........................................................................................................................................................................10-1
10.2 Application of "System Maintenance" window ....................................................................................... 10-1

10.2.1 Reset analyzer ................................................................................................................................................................10-2
10.2.2 Check cuvette blank and light intensity ..........................................................................................................................10-3
10.2.3 Exhaust air......................................................................................................................................................................10-4
10.2.4 Rinsing ...........................................................................................................................................................................10-5
10.2.4 Mechanism check ...........................................................................................................................................................10-7
10.2.5 Water quality check......................................................................................................................................................10-11
10.2.6 Barcode ......................................................................................................................................................... 10-11
10.2.8 ISE................................................................................................................................................................................10-12
10.3 System maintenance position and parts ................................................................................................. 10-16

10.3.1 Clean, check and replace parts regularly ..................................................................................................................... 10-16
10.3.2 Spare parts for regular replacement and maintenance ................................................................................................. 10-17
10.4 Maintenance methods .............................................................................................................................. 10-18

10.4.1 Probe ........................................................................................................................................................................... 10-18
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10.4.2 Reaction disk ............................................................................................................................................................... 10-23
10.4.3 Light source lamp ........................................................................................................................................................ 10-27
10.4.4 Nozzles of rinsing mechanism .....................................................................................................................................10-28
10.4.5 Mixing bar ................................................................................................................................................................... 10-29
10.4.6 Cleaning refrigeration chamber ....................................................................................................................................10-31
10.4.7 Syringe pump .............................................................................................................................................................. 10-32
10.4.8 Maintenance of the Analyzer before stop .................................................................................................................... 10-32
10.4.9 Cleaning and maintenance of the Analyzer ..................................................................................................................10-32
10.4.10 Waste liquid treatment ...............................................................................................................................................10-33
10.4.11 Cleaning of pure water tank and filter ....................................................................................................................... 10-33
10.4.12 Replacement of thermostatic degassing system .........................................................................................................10-34
10.5 Maintenance of electrolyte device ........................................................................................................... 10-35

10.5.1 Clean, check and replace parts regularly ..................................................................................................................... 10-35
10.5.2 Rinsing of ISE matching cuvette ..................................................................................................................................10-35
10.5.3 Rinsing of ISE reagent tubing ......................................................................................................................................10-35
10.5.4 Replacement of electrode .............................................................................................................................................10-36
10.5.5 Replacement of tube for pinch valve ........................................................................................................................... 10-38
10.5.6 Rinse flow cell ............................................................................................................................................................ 10-38
10.5.7 Maintenance of Cl electrode.........................................................................................................................................10-38
10.5.8 Rinsing of ISE waste liquid part...................................................................................................................................10-39
10.6 Scrapped analyzer .................................................................................................................................... 10-40
Chapter 11 Alarm and Treatment of the Analyzer ................................................................... 11-1

11.1 Type of alarm message ............................................................................................................................... 11-1
11.2 Solutions for faults without alarm ............................................................................................................ 11-1
11.2.1 Abnormality of data without alarm ................................................................................................................................ 11-1
11.2.2 Faults of the Analyzer without alarm ............................................................................................................................. 11-2
11.3 Alarm message and solutions..................................................................................................................... 11-3
Chapter 12 Transport and storage .............................................................................................. 12-1

12.1 Transport .................................................................................................................................................... 12-1
12.2 Storage ......................................................................................................................................................... 12-1
Appendix A Letter of guarantee ...................................................................................................A-1
Appendix B Product description .................................................................................................. B-1
Appendix C Parameters of common biochemical reagents of AGAPPE .................................C-1
Appendix D Cross contamination reference table ......................................................................D-1
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Appendix E Reference of abnormal result marks....................................................................... E-1
Appendix F LIS Network Interface Instruction V1.01............................................................... F-1
Appendix G Reference for consumption of detergent and ISE reagent .................................. G-1
Appendix H Performance indexes ............................................................................................... H-1
Appendix I Parts list ....................................................................................................................... I-1
Appendix J Statement on electromagnetic compatibility............................................................J-1
Appendix K Processing method for software sleep.................................................................... K-1
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User Manual
Chapter 1 Brief introduction
1.1 Overview
The Auto-Chemistry Analyzer (model: MISPA CXL PRO) is a discrete type modular analyzer with an external
computer and it is used for emergency treatment with priority.
The Analyzer has functions including automatic reagent dispensing, preheating, sample dispensing, interference
shielding, mixing, reaction test, rinsing and results calculation, display and printing. It fully imitates and substitutes
manual operation, which not only improves work efficiency, but also reduces test error and improves the accuracy
and precision of test results.
Scope of application: Quantitative analysis of clinical chemical components such as serum, plasma, urine and
cerebrospinal fluid.
1.2 Major indicators

Items Contents
Flat field grating type beam-splitting system, simultaneous photometric data
Wavelength collection and processing of 12 wavelengths; The specific wavelengths are 340nm,
coverage 380nm, 405nm, 450nm, 480nm, 505nm, 546nm, 570nm, 600nm, 660nm, 700nm,
800nm.
Reaction
37℃
temperature
Basic Control accuracy of

±0.1℃
characteristics temperature
Test items 80 colorimetric items
Test method 1-point endpoint assay, 2-point endpoint assay, 2-point rate assay, rate A assay
Colorimetric items: Constant-speed 240 tests/ hour,

Test speed
Reagent disk,
Maximum 80 reagent positions, with refrigeration
reagent position
Reagent volume 10μL~300μL, step 0.1μL

Volume of reagent
20mL,35mL,70mL
bottle
Sample and reagent
2℃～12℃
storage temperature
Sample/reagent Sample and reagent
system bar code recognition 1 built-in bar code reader (optional)
system
Probe liquid level
Integrated with probe
sensor
Sample loading
Maximum 80 sample positions, with refrigeration
capacity at one time
Sample type Serum, plasma, urine, ascites, cerebrospinal fluid
Sample volume 2μL~35μL, step 0.1μL
Interface RJ45 network interface
Computer
Data system Optional computer and printer
configuration
Connected system Can be connected to LIS/HIS
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Items Contents
Cuvette type Discrete type

Optical path of
5mm
cuvette
Reaction position of
8 sets, 7 for each set, totally 56 positions
the Analyzer
Reaction time 13min

Total volume of
100μL～360μL
reaction solution
Light source 20W/12V quartz-halogen lamp with a long service life
Analysis
system
Absorbance range 0~5.7Abs
Absorbance linear
0~3.5Abs
Range
Real-time QC, daily QC, inter-day QC and analysis on losing control with
QC
double-concentration method
Automatic rinsing Automatic rinsing of cuvette
Mixing system Independent mixing after reagent dispensing
Temperature control
Thermostat air bath
system
Weight 100kg
Complete
Boundary
machine 744×703×530(L×W×H)
dimension (mm)
system
Rated power 600VA
*
● If the total volume of reaction solution is 100μL, the accuracy of test results may be affected by partial
items.
● Due to different testing conditions, the handling capacity of MISPA CXL PRO Analyzer may be lower
than 180
240 tests/ hour.
Testing conditions Handling capacity (estimated)
Testing after sample pre-dilution 90 tests/ hour (all under pre-dilution condition)
≤240 tests/ hour (when there are few cross-contamination items, the
Cross-contamination avoidance function
system will automatically arrange not to slow down)
Normal operating conditions of the Analyzer:

(1)Power voltage: 100V-240V~ 50/60Hz
(2)Environmental temperature: 15℃~32℃
(3)Relative humidity: not greater than 75%
(4)No magnetic field nearby
(5)Prevent direct strong light exposure
(6)Atmospheric pressure: 75kPa~106kPa
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1.3 Composition of the Analyzer

1.3.1 Appearance of the Analyzer
1.3.1.1 Front View of Analyzer
1 Status indicator lamp

Fig. 1-3-1
Note:
Status indicator lamp description:
(1)Green constant light means the Analyzer is working normally.

(2)Blue constant light means sampling pause or standby.
(3)Green flicker means the Analyzer cannot work normally.
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1.3.1.2 Rear view of the Analyzer
1 Network interface 2 Pure water sensor port 3 Waste liquid sensor port
4 Concentrated waste liquid drainage port 5 Diluted waste liquid drainage port 6 Pure water dispensing port
7 Reference Solution 8 Internal Standard Solution 9 Diluent
Fig. 1-3-2
1.3.1.3 Left view of the Analyzer
1 Halogen lamp replacement window 2 Alkaline detergent replacement window

Fig. 1-3-3
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User Manual
1.3.1.4 Right view of the Analyzer
1 Power socket 2 Fuse holder 3 Master power switch 4 Refrigeration indicating lamp (green)
5 Analysis indicating lamp (red) 6 Power switch of analysis module 7 Electrode replacement window
Fig. 1-3-4
1.3.1.5 Top view of the Analyzer
1 Reaction disk 2 Rinsing mechanism 3 Mixing mechanism 4 Syringe pump observation window
5 Probe rinsing bath 6 Mixing bar rinsing bath 7 Probe mechanism 8 Sample and reagent disk
Fig. 1-3-5
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1.3.2 System composition of the Analyzer
Fig. 1-3-6 System composition
1.4 Structure and functions of the Analyzer

(1) The host of the Analyzer is composed of optical system, mechanical motion system, fluid circuit system,
electronic control system and software system.
(2) The optical system, mechanical motion system, fluid circuit system and electronic control system compose the
Analyzing module of the Analyzer and the software system of the Analyzer composes the Operation unit of the
Analyzer. The two parts are connected through a reticle.
1.4.1 Operation unit
The Operation Part is composed of the host, display, keyboard, mouse and printer.
Host: Installed with Win7 32-bit Chinese family version or Win7 32-bit English professional version, special
application software and database.
Basic configuration: CPU main frequency ≥2.8GHz, hard disk 500G, memory ≥4G, independent graphics card
memory≥1G, with RS-232 serial port, network port and USB port.
Display: 20'' LCD display displays the windows, curves and test data of software of the Analyzer, with resolution
≥1920×1080.
Keyboard: Control the operation of the Analyzer and input data.
Mouse: Operate software.
Printer: Print the tested data and charts.
1.4.2 Analyzing module
The analyzing module of the Analyzer consists of a probe mechanism, sample/reagent disk, reaction disk, mixing
mechanism, rinsing mechanism and optical system. They are introduced below.
1.4.2.1 Probe mechanism
When the Analyzer is operating, please do not touch the probe mechanism as it may cause personal injury or
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damages of the Analyzer.
1 2 3 4
1 Probe rinsing bath 2 Probe lifting mechanism 3 Swing arm of probe 4 Probe
Fig. 1-4-1
(1)Functions
It is used to aspirate sample of set volume from the sample container and then dispense it to the cuvette. Meanwhile,
it has liquid level detection function. It will alarm if the probe collides with something.
(2)Specifications
The probe mechanism can aspirate sample of 2μL~35μL, and can increase by 0.1μL progressively; ISE sample
volume is fixed at 45μL. It can aspirate reagent of 10μL~300μL and the reagent volume can increase by 1μL
progressively.
(3)Motion
After the power is connected, the probe will swing to above the rinsing bath first, and then to above the cuvette and
then return to above ISE, finally to above the rinsing bath.
During the analysis, the probe moves, rises and lowers in the sequence of sample container (reagent bottle) →
cuvette → probe rinsing bath. The probe will be rinsed after each sample or reagent dispensing. The action when the
analysis is started and the action when the power is connected are the same. The inner and outer walls of the probe
will be rinsed above the rinsing bath.
During resetting, the action is the same as the action when the power is connected.
To aspirate sample/reagent, the probe will lower to about 3mm below the liquid surface and then start sample
aspirating.
(4) Automatic rinsing
Automatic rinsing of probe: After a sample/reagent is dispensed, the probe will return back to above the rinsing bath
to rinse the inner and outer walls of the probe.
(5) Motion check
Select "Mechanical Action Check" on "Mechanism check" of the "System maintenance" window, and then input
the number of checks and click " ". The Analyzer will give an alert to alarm in case of any
abnormities.
1.4.2.2 Sample disk/reagent disk
When the Analyzer is operating, please close the cover of sample/reagent disk and do not touch the cover of
sample/reagent disk as it may cause personal injury or damages of the Analyzer.
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1 2 3 4 5
1 Sample/reagent disk cover 2 Disk cover handle 3 Reagent bottle
4 Sample/reagent disk lock knob 5Sample/reagent disk handle
Fig. 1-4-2
(1)Functions
The sample/reagent disk is used to place standard cup, test tube and reagent bottle and transport the sample, reagent
and CXL Pro anti-bacterial phosphor-free detergent to the aspirating position of probe mechanism. The cooling
system can be used to cool the sample/reagent disk to hold reagent with temperature requirements. The refrigeration
bin is provided with a window for barcode reader that can be used scan the barcodes on test tubes and reagent bottles.
(2) Specifications
It is used to place test tubes, standard cups, reagent 1, reagent 2 and CXL Pro anti-bacterial phosphor-free detergent,
with totally 120 positions.
Volume of reagent bottle: 70mL, 35mL, 20mL.
Specifications of test tube: Φ12mm×75mm, Φ12mm×100mm, Φ13mm×75mm, Φ13×100mm.
Standard cup, original blood collection tube.
(3) Motion
When the power is connected, it will rotate in anticlockwise direction to transport the #1 position of sample/reagent
disk to the sample/reagent aspirating position of probe mechanism.
During analysis, the action in early stage is the same as the action when the power is connected. It will move to a
close position to transport next reagent.
(4) Disassembly
The 2 sample/reagent disk lock knobs in central disk are used to fix sample/reagent disk. To disassemble the disk,
the lock knobs shall be loosened first. During installation, please align the positioning hole of sample/reagent disk to
the guiding pin bolt and fix with lock knobs.
Unless for the replacement of the sample/reagent disks or sample or reagent, the sample/reagent disk cover shall be
always closed to maintain the temperature in the refrigeration bin. Besides, please do not take off the sample/reagent
disk cover when the Analyzing is operating as the probe also moves in this process.
(5) Motion check
abnormities.
(6) Position description
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Fig. 1-4-3
The sample reagent disk consists of three circles:
Place the sample tube or standard cup at the outer ring position 1~40, corresponding to the position number 01~40
of the "Sample Registration" interface (see Section 8.2.7 Sample Registration); the position number corresponds to
that on the sample reagent disk outer circle position indicator disk.
Reagent bottle (excluding position 1 of middle circle) is placed in middle circle position 1~40/inner circle position
1~40, if only a 70mL reagent bottle is placed, it corresponds to the "reagent registration" interface’s outer 02~ outer
40; if a 20mL reagent bottle is placed in the middle circle, it corresponds to the "reagent registration" interface’s
outer 02 ~ outer 40, and a 35mL reagent bottle can be placed in the inner circle at the same time, it corresponds to
the "reagent registration" interface’s inner 01 ~ inner 40 (see 8.2.5 reagent preparation); The position number
corresponds to that on the sample reagent disk middle circle/inner circle position indicator disk.
1.4.2.3 Reaction disk
When the Analyzer is operating, please close the cover of reaction disk and do not touch the cover of reaction
disk as it may cause personal injury or damages of the Analyzer.
1 2 3 4 5 6
1 Reaction disk cover 2 Cuvette installation disk 3 Cuvette installation disk knob
4 Cuvette installation disk pin 5 Cuvette 6 Cuvette fixing screw
Fig. 1-4-4
(1)Functions
After the cuvette is fixed on the reaction disk with fixing screws, the reaction solution will have reaction in the 37℃
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incubation bath and then absorbance measurement will be carried out in the rotating process.
(2)Specifications
Number of cuvettes: 7 pcs./set ×8 sets, totally 56 cuvettes.
Optical path: 5mm.
Material of cuvette: optical plastics
(3)Motion
It rotates in anticlockwise direction normally.
When the power is connected, it will rotate and stop at the initial position. At this time, #1 cuvette is below the
rinsing nozzle.
During analysis, the action is the same as the action when the power is connected. It will reach the dispensing
position after one rotation, reach the mixing position after another one rotation and then finish the action in a cycle
after two times of rotation. The reaction disk will take 20 seconds to have a rotation cycle.
(4)Rinsing of cuvette
Execute Rinse cuvette on the System maintenance window to rinse all cuvettes. However, as the Analyzer rinses the
cuvettes with the CXL PRO alkaline detergent in reagent bottle ahead automatically, it is unnecessary to maintain
the cuvettes every day.
(5) Motion check
abnormities.
(6) Disassembly
Cuvette: remove the cover of the reaction disk, remove cuvette fixing screws and hold the handle of cuvette to lift it
to remove the cuvette from the reaction disk.
Reaction disk: Take the rinsing mechanism from the reaction disk cover first, and then remove the reaction disk
cover and take off the three screws fixing the cuvette mounting disk. And then rotate the cuvette mounting disk
handle to a certain height in anticlockwise direction to lift the cuvette mounting disk. At this time, remove the fixing
screws of cuvette and lift the handle of cuvette to take the cuvette from the reaction disk. During installation, align
the guiding hole of cuvette mounting disk to the guide pin bolt on reaction disk holder first, and then fix the three
screws on cuvette mounting disk and fasten the cuvette mounting disk handle in anticlockwise direction. It shall be
ensured the cuvette mounting disk is reliably installed.
During the disassembly, please do not touch the photometric surface of cuvette with hands. The cuvette taken
down shall be soaked in pure water. In addition, take off the cuvette to soak it in 2% CXL Pro anti-bacterial
phosphor-free detergent if the Analyzer will not be used for more than 3 days.
1.4.2.4 Incubation bath
● The incubation bath shall be kept clean and no fragments or filaments are allowed inside to prevent
affecting the test accuracy.
● The incubation bath shall be regularly cleaned (every month). When cleaning the incubation bath, use
moistened gauze to wipe clean the inside of the incubation bath.
(1)Functions
It can keep a constant temperature of the reaction solution in cuvette.
(2)Motion
When the power is connected, the incubation bath will enter a preheating status automatically.
During analysis, the air in incubation bath is circulated and the Analyzer will alarm in case of abnormities.
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1.4.2.5 Mixing mechanism
Please do not touch the mixing mechanism when it is operating as it may cause personal injury or damages of
the Analyzer.
(1)Functions
It is used to mix the reaction solution in cuvette.
(2)Motion
When power is connected, the mixing bar will swing to above the rinsing bath first, and then to the side of cuvette,
above the mixing and rinsing bath again and then stop.
During analysis, the mixing bar will swing in the sequence of Mixing and rinsing bath → cuvette. At the two
positions, it will have actions including lowering, rotating, lifting and then stop rotating.
(3)Automatic rinsing
Automatic rinsing of mixing bar: After the mixing bar lowers to the mixing bar rinsing bath, it will be rinsed with
pure water in rotation automatically.
Completion of dispensing: The mixing bar will be rinsed in the process that the bar mixes in the cuvette with
detergent.
(4)Motions check
abnormities.
1.4.2.6 Rinsing mechanism
● Please do not touch the rinsing mechanism when it is operating as it may cause personal injury or damages
of the Analyzer.
● Prevent the liquid from the nozzle of rinsing mechanism touching body directly as it may cause infection or
skin injury. Please take protection measures. If the liquid touches skin or eyes, please flush with water and
conduct disinfection immediately.
(1)Functions
It can be used to pump the reaction solution after the completion of reaction, rinse the cuvette and dispense or pump
the pure water for testing cuvette blank.
(2)Composition of rinsing nozzle
Fig. 1-4-5
It can be seen from Fig. 1-4-5 that the cuvette will be rinsed by a set of rinsing mechanism and the rinsing has 8 steps
(3 times of cuvette blank test are added in the rinsing process). Therefore, the rinsing of a cuvette has 11 steps.
Step 1 and 2: Nozzle 1B aspirates reaction mixture and then 1A dispenses pure water to the cuvette; Then Nozzle
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1B aspirates reaction mixture and then 1B dispenses alkaline detergent to the cuvette.
Step 3 and 4: Nozzle 2D aspirates the diluted alkaline detergent in cuvette and then 2C dispenses pure water to the
cuvette; Then Nozzle 2D aspirates pure water and then 2C dispenses pure water.
Step 5 and 6: Conduct 2 cuvette blank tests.
Step 7 and 8: Nozzle 3E aspirates the pure water in cuvette and then 3F dispenses pure water to the cuvette; execute
for two times.
Step 9: Conduct 1 cuvette blank tests.
Step 10 and 11: Nozzle 4G aspirates the pure water in cuvette and wipes the cuvette; execute for two times.
(3)Motion
When the power is connected, it will lower for about 5mm first and then rise.
During analysis, it will rinse the cuvette in the rotating direction of cuvette shown in Fig. 1-4-5 and conduct a
cuvette blank test.
(4)Motions check
abnormities.
(5)Disassembly
The rinsing system can be taken from the host by unscrewing the fixing screws. During installation, the rinsing
mechanism shall be connected with mechanism base by fastening the locating pins and fixing screws between them.
1.4.2.7 Refrigeration system
(1)Composition and functions
The refrigeration system applies Peltier air cooling and it refrigerates sample and reagent, QC solution and standard
solution.
(2)Specifications
Refrigeration temperature: 2℃~12℃.
● The refrigeration system will be under working status even though the power switch of the Analyzing
module is turned off. The refrigeration system will stop working only after the master power switch of the
Analyzer is turned off.
● The use, storage and handling of reagent shall strictly follow the instructions of the reagent.
● Please clean the refrigeration bin regularly.
1.4.2.8 Optical system
(1)Functions
It is used to measure the absorbance of pure water and reaction solution in cuvette when the reaction disk is rotating,
as shown below.
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Fig. 1-4-6 Diagram of photometer

(2)Specifications
Use 12 wavelengths (340nm, 380nm, 405nm, 450nm, 480nm, 505nm, 546nm, 570nm, 600nm, 660nm, 700nm,
800nm) to have photometry based on double wavelengths or single wavelength.
Wavelength accuracy: ±2nm.
Absorbance linear Range: 0Abs ~3.5Abs.
Detector: Silicon photodiode.
Light source: 20W/12V quartz halogen lamp with a long service life.
1.5 Symbols
Table 1-5-1
Symbol Meaning
BIOLOGICAL RISKS
LASER, DANGER SYMBOL
ALTERNATING CURRENT
IN VITRO DIAGNOSTIC MEDICAL DEVICE
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
MANUFACTURER
THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON IN VITRO DIAGNOSTIC

MEDICAL DEVICES
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Symbol Meaning
AUTHOR
D REPRESENTATIVE IN THE EUROPEAN COMMUNITY
The symbol of the crossed out wheeled bin indicates that the product (electrical and electronic
equipment) should not be placed in municipal waste. Please check local regulations for disposal of
electronic products.
CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK DETAILED WARNING

OR MATTERS NEEDING ATTENTION
CATALOGUE NUMBER
"ON" (POWER)
"OFF" (POWER)
PROTECTIVE EARTH
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Caution, hot surface
The symbols above may be found on the Analyzer, reagent, QC object and calibration object.
1.6 Signs
(1)
(2)
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(3)
(4)
(5)
(6)
1.7 Working principle of the Analyzer

1.7.1 Operating positions of mechanisms
The relative position of cuvette and probes on reaction disk is shown in the figure below:
R1&S and R2&S mixing position
Sample and R1/R2

dispensing position
Rinsing position
Fig. 1-7-1 Operating positions of mechanisms
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1.7.2 Analysis flow chart

The test flow is shown in the figure below:
Pump and aspirate water

Conduct 3 cuvette blank
Dispense R1 reagent
Dispense R2 reagent
Test reagent blank
Test of 1# cuvette
Dispense sample
Rinse cuvettes
Movement stops
Rinse cuvette
Start test
(standby)
finished
Reset
tests
Mix
Mix
Fig. 1-7-2 Analysis flow chart
Note:
Taking reaction time as 13.5min as an example.

1.7.3 Photometric characteristics
The Analyzer applies the whole-process photometry method. That is, the absorbance of reaction solution is
continuously measured in the 13.5min reaction time. The absorbance of 56 cuvettes will be measured one by one
when they pass the optical axis of photometer. The absorbance of each cuvette will be measured for 40 times (40 test
points) in the 13.5min reaction time. The white light from the light source will be focused by the lens and then pass
the cuvette used for photometry. The wavelength after light split will be absorbed simultaneously by 12 fixed
photoelectric sensors and amplified by 12 amplifiers respectively. Then, the absorbance or absorbance change rate
will be calculated. When dual-wavelength test is applied, as the difference of the absorbance or the difference of
absorbance change rate of main wavelength and sub-wavelength is used to calculate the concentration, dual-
wavelength test not only makes compensation to the sample test of lipemia, hemolysis and icterus but also
compensates the effects caused by voltage variation, making the test values more accurate and stable.
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Chapter 2 Installation of the Analyzer
The Analyzer and bundled software can only be installed by AGAPPE or its authorized personnel.
2.1 Installation requirements
Please install the Analyzer at places meeting following requirements, or its performance may not be
guaranteed.
2.1.1 Space requirements
The installation and use of the Analyzer shall meet following requirements.
Operation
Analytic Part Part
At least At least
500 Unit: mm 500
Fig. 2-1-1 Top view of installation space
Do not put the Analyzer at a place where the disconnecting device is hard to be operated.
2.1.2 Environmental requirements
(1)Environmental temperature: 15℃~32℃.
(2)Relative humidity: not greater than 75%.
(3)Atmospheric pressure: 75kPa~106kPa.
(4) The Analyzer shall be put in a dust-free environment with good ventilation but no mechanical vibration, no
source of large noise or power interference.
(5) Do not put the Analyzer near brush motor, scintillant fluorescent lamp and electrical contact equipment often
used.
(6) The Analyzer shall be prevented from direct sunlight exposure and not be placed near heat and wind sources.
(7)The maximum volume of the area 1m away from the Analyzer shall be at 70dB.
(8)The worktable shall be flat and able to bear a weight of greater than 150kg. (The Analyzer shall not be
disassembled into several independent parts and weight of major components are not shown)
● If the temperature and the humidity cannot meet requirements above, air conditioner shall be used.
● In the operating process, the Analyzer will generate heat and exhaust the heat at the back. The working
environment should be kept well ventilated, and ventilating device should be used if necessary. But the
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Analyzer should be protected from the direct airflow, otherwise, the test accuracy may be affected.
2.1.3 Power requirements
(1)Power voltage: 100V-240V~ 50/60Hz.
(2)Power consumption: 600VA.
Notes:
During normal operation, the Analyzer has power consumption smaller than the rated maximum power
consumption because:
● the refrigeration and heating systems do not work continuously after the Analyzer becomes stable. Thus
the power consumption will decrease.
● the power components of the Analyzer work at a different time rather than work simultaneously.
(3) Fuse: F6.3AL250V 5mm×20mm.
(4) To ensure the reliable operation of the Analyzer, a 20A switchboard shall be used for the Analyzer and three 5A
receptacles shall be used for the display, and printer; the equipment with a heavy load such as air conditioners and
refrigerators shall not be plugged into the same socket.
● The power source shall be properly grounded, otherwise, operators may get an electric shock and the
system may get damaged.
● The receptacle connected with power cable shall be placed near the Analyzer and easily disconnected.
● Input voltage of the Analyzer shall meet the requirement. It is recommended that the hospital prepares a
3kVA or 6kVA online UPS power source.
2.1.4 Requirements for pure water
The peak water consumption of the Analyzer is about 3L per hour. Pure water and pure water tank shall meet the
following conditions:
(1)The electric conductivity of the pure water shall be smaller than 1μs/cm.
(2)Pure water temperature is 15℃~30℃.
(3) The pure water tank provided with the Analyzer shall be placed on the ground and the tubing connected with the
Analyzer shall be within 1.5m.
(4) The water supply capacity of the pure water tank shall be above 5L/h.
2.2 Unpacking
2.2.1 Unpacking steps
After the arrival of the Analyzer, please carefully check the package of the Analyzer. If it is damaged, please contact
AGAPPE or the local distributor. If the package is intact, please unpack the Analyzer by following the steps below.
(1) Put the box in the direction pointed by the arrow.
(2) Open the box of accessories and check objects in the box according to the packing list. In case of items missing,
please fill it in the Installation Acceptance Report and contact AGAPPE or the local distributor.
(3) Open the Analyzer with appropriate tools in the accessory box, inspect the appearance of the Analyzer carefully,
and then check according to the packing list. In case of damages in carrying or shortage of parts, please fill it in the
Installation Acceptance Report and contact AGAPPE or the local distributor.
2.2.2 Way of carrying
(1) Push directly during a stable transportation in short distance.
(2) The Analyzer should be maintained upright when handling and transporting.
(3)Try to avoid vibration when handling.
As the Analyzer is stationary equipment, it shall not be moved in a normal working process and no supporting
device for lifting and carrying is provided.
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2.3 Installation process

2.3.1 Installation of the Analyzer
(1)Put the Analyzer at an appropriate position and adjust the levelness of the Analyzer.
(2)Install a probe and check whether the probe mechanism is able to move flexibly.
(3)Install the cuvette.
(4) Dispense 1000mL alkaline detergent to the alkaline detergent bottle, open the alkaline detergent replacement
window at the left side of the Analyzer, put the alkaline detergent bottle inside the Analyzer and install the tubing
and float.
(5) Connection of pure water tubes
Dispense 10L pure water with conductivity less than 1μs/cm in pure water tank, use the pure water supply tube
(within 1.5m) to connect the outlet connector of the pure water tank with the pure water dispensing port (1 in Fig.
2-3-1) on the rear cover of the Analyzer, and then use the pure water float switch to connect the pure water tank with
the pure water liquid level switch (5 in Fig. 2-3-1) on the rear cover of the Analyzer.
Fig. 2-3-1
(6) Connection of waste liquid tubes
a) High-concentration waste liquid outlet tubing: connect one end of waste liquid connecting tube with the
connector of "high-concentration waste liquid outlet" (3 in Fig. 2-3-1) on the rear cover of the Analyzer (with
another end inserted on the connector of the waste liquid tank).
b) Low-concentration waste liquid outlet tubing: connect the other end of waste liquid connecting tube with the
connector of "low-concentration waste liquid outlet" (2 in Fig. 2-3-1) on the rear cover of the Analyzer (with
another end inserted on the connector of the waste liquid tank or the drainage system.
c) Liquid level sensor connection: insert one end of the waste liquid level sensor to the "Waste liquid level sensor
port" (6 in Fig. 2-3-1) on the rear cover of the Analyzer and install the other end in two waste liquid tanks. SW4 is
a high-concentration waste liquid level sensor and SW7 is a low-concentration waste liquid level sensor.
● Low-concentration waste liquid tube outlet shall not be immersed below the liquid level.
● The low-concentration waste liquid tubing must not be bent or swung. It should be flat like a parabola.
● The waste liquid tank should be 0.8m~1m lower than the host.
● Don't combine high and low concentration waste liquid tubing.
● The discharge of the high-concentration waste liquid shall observe the local medical waste treatment
regulations.
● The drainage system shall be in compliance with the local regulations with regard to sewage discharge and
treatment of medical institutions.
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(7) Install ISE electrode (optional)
Make sure that the storage temperature of the electrode is at 1℃~51℃.

a) Open ISE maintenance window on the right cover:
Fig. 2-3-2
b) Screw off the flow cell set screws on electrode assembly to lift up electrode assembly as shown in the figure
above.
c) Screw off nuts K, Cl, Na and NaREF on the flow cell (as shown in Fig. 2-3-3), take off the matching seal plugs
and seal rings; nuts K, Cl, Na and NaREF are kept for installing electrodes Cl, K, Na and NaREF, and the
matching seal rings are for no other uses and can be handled by users themselves. (See Fig. 2-3-4 for removed seal
plugs and matching seal rings):
If the seal ring on the seal plug falls into flow cell by accident, please take it out with a cotton swab (do not use
the hard material to take it out directly).
1 5
1 K-nut, K-seal plug, seal ring 2 Cl-nut, Cl-seal plug, seal ring 3 Flow cell
4 Na-nut, Na-seal plug, seal ring 5 NaREF-nut, NaREF-seal plug, seal ring
Fig. 2-3-3
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1 2 3
1 Seal ring 2 Seal plug 3 Nut

Fig. 2-3-4
d) The packages of electrodes Cl, K, Na and NaREF are as shown in the figure below. The electrodes shall be
installed in accordance with the instruction on the package box of each electrode to prevent any installation faults.
1 The packaging of Na electrode (NaREF electrode) 2 The packaging of CI electrode

3 The packaging of K electrode tip 4 The packaging of K electrode
Fig. 2-3-5
e) Install electrodes Cl, K, Na and NaREF (same as electrode Na) on the flow cell according to following steps:
Place O-seal ring properly during the installation (#4 in Fig. 2-3-6) to prevent the loss.
 Unpack the package of K electrode tip and K electrode wire, and take out the electrode and related accessories
in the package.
 Install O-seal ring (#4 in Fig. 2-3-7) on the K electrode wire smoothly, wring K electrode tip (#10 in Fig. 2-
3-7) on K electrode wire, and then install the seal ring of the electrode (#9 in Fig. 2-3-7) on the K electrode tip
smoothly to compose electrode K (the installation method as shown in Fig. 2-3-7).
 Wipe the liquid in electrode holes on the flow cell clean with a cotton swab; wipe the electrode clean with a
cotton swab as well.
 Put the electrode K through nuts (as shown in Fig. 2-3-7), ensure that the seal ring of the electrode is installed
on the K electrode tip smoothly, and wring the installed electrode assembly on the flow cell.
Lock nuts by hands with moderate strength during electrode installation.
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1 11 4 10 9 8 7
2 3 5 6
Fig. 2-3-6
1 11 4 10 9
Fig. 2-3-7
1 K nut 2 Cl nut 3 Cl electrode 4 O-seal ring 5 Na electrode 6 Na nut
7 Na nut 8 Na electrode seal 9 the electrode seal ring 10 K electrode tip 11 K electrode wire
 Install electrodes Cl, Na and NaREF on flow cell at the corresponding positions as per the method above.
f) Connect the other end of the flow cell with electrodes Cl, K, Na and NaREF installed on one end and the
preamplifier board connector as shown in the figure below:
Note:
1 NaREF electrode connector 2 Cl electrode connector

3 K electrode connector 4 Na electrode connector
Fig. 2-3-8
Differences between the electrodes are as follows:
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● K electrode tip is removable;

● The surface of electrode Na is made of glass;
● The surface of electrode CI is made of metal.
g) Push the electrode assembly back to original position and install it with the set screws.
h) Install the ISE electrode on the platform and replace the cover plate and set screw.
2.3.2 Power connection
Before power connection, ensure the main power switch (circuit breaker) of the Analyzer is at OFF position.
The Analyzer is accompanied with three-core power cable, wherein the red one is the live cable, the blue one is the
neutral cable and the yellowish green is the ground cable, and the rated temperature of the three-core power cable is
70℃.
2.3.3 Connection of peripheral equipment
(1) Install and connect the computer, display and printer and check:
a)Whether the printer driver is installed.
b)Specification of printing papers used in the printer.
(2) One end of the cable that is carried along with the computer is plugged onto the network interface of the Analyzer
and the other end is plugged onto the network interface of the host computer.
2.3.4 Software installation and uninstallation
2.3.4.1 Software installation
Put the Analyzer installation disk in computer CD driver, and run the setup.exe file, and the interface is as shown
below:
Fig. 2-3-9
Select the installation program language, then click "OK" and the display is as shown below:
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Fig. 2-3-10
Click "Next", and the display is as shown below:
Fig. 2-3-11
To change the installation path, click "Browse" in the figure above to select the installation path; click "Next" to use
the default installation path and the display is as shown below:
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Fig. 2-3-12
Click "Finish" to finish the software installation, and the icon of the application software will be generated on the
desktop automatically.
2.3.4.2 Software uninstallation
Method I: select "Automatic test analyzer" in "Programs and Features" on computer control panel, click to select
" ", and the figure below pops up:
Fig. 2-3-13
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Fig. 2-3-14
Click "Next", and the display is as shown below:
Fig. 2-3-15
Click "Yes", and the display is as shown below:
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Fig. 2-3-16
Click "Finish" to finish uninstalling the Analyzer software.
Method II: click "Start", find out "Auto-Chemistry Analyzer" in "Programs" and then click "Uninstall MISPA CXL
PRO Auto-Chemistry Analyzer", and an uninstallation confirmation window appears. The uninstallation process is
the same as Method I.
2.3.5 Pure water filling
1
1
3 2
Fig. 2-3-17
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If it is necessary to use the pure water tank to take away the pure water for filling, from the pure water tank take out
the pure water float switch (#3 as shown in Fig. 2-3-17), remove the water tube (#2 as shown in Fig. 2-3-17) and
tank cover (#4 as shown in Fig. 2-3-17) and place them on somewhere clean to use the pure water tank (#5 as shown
in Fig. 2-3-17) to take away the pure water for filling and install the parts above successively on the pure water tank
after the filling; if it is unnecessary to use the pure water tank to take away the pure water for filling, remove the tank
cover (#4 as shown in Fig. 2-3-17) directly and place the tank on somewhere clean to fill pure water in the pure
water tank.
● Every month as pure water is filled, when removing the water pipe (Fig. 2-3-17, No. 2), observe whether
there is any hair, wire, and other debris in the filter of the end of observation part 2. If there is, the filter
should be removed and rinsed (refer to section 10.4.11). If it cannot be rinsed clean, replace the new filter.
● The removed immersed tube shall not be thrown with force to prevent a large volume of air from entering
in the tube or the thrown liquid from injuring personal safety.
2.3.6 Discharge of waste liquid
See "2.3.1 Analyzer installation" and "10.4.10 Waste liquid treatment" for specific discharge of waste liquid in
waste liquid tank.
● Low-concentration waste liquid tube outlet shall not be immersed in liquid level.
● The low-concentration waste liquid pipeline must not be bent or swung. It should be flat like a parabola.
● Don't combine high and low concentration waste liquid tubing.
● The discharge of the high-concentration waste liquid shall observe the local medical waste treatment
regulations.
● The drainage system shall be in compliance with the local regulations with regard to sewage discharge and
treatment of medical institutions.
2.3.7 System login
Connect the power sources of the water purifier, computer host, computer display and printer and analyzing module
(at the front right side) of the Analyzer as well as the main power source of the Analyzer (at the rear right lower side
of the Analyzer).
Double click the icon " " of Analyzer application software (hereinafter referred to as software); or click "Start",
find the Analyzer software on "Program" window and click it to enter the "System login" window, and the display is
as shown below:
Fig. 2-3-18
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Fig. 2-3-19
Input correct user name and password (the initial user name of the Analyzer software is 1 and the initial password is
1), click "Login" or Enter key on the keyboard to enter the main window of the software, and the display is as shown
below:
Fig. 2-3-20
After the software is logged in successfully, the offline status is displayed. Then you can browse the function
window, check the alarm information, and execute logout and exit.
On the interface as shown in Fig. 2-3-19, if the wrong user name and password are input, a login failure prompt will
be given on the screen and the display is as shown below:
Fig. 2-3-21
If wrong user name or password is input for three continuous times, a prompt of "Login failure for 3 times and the
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program will be terminated" will be given. Exit the program after the confirmation.
The function keys in the interface as shown in Fig. 2-3-20 are as follows:
(1) Online: click " " and after successful network connection, " " will be
displayed on the status bar at the upper left corner. Now all the operations are available.
If after software login, power source of the analyzing module of the Analyzer is disconnected or the analyzing
module is not correctly connected with the operation unit, click "Online", "Connecting" is displayed on the status
bar and "Online failure" (on the lower left corner of the screen) is displayed a few seconds later.
If above prompt is given, connect the analyzing module and operation unit of the Analyzer correctly, connect power
source of the analyzing module and then connect the network.
(2) Exit the system: click " " in the shortcut keys area to enter the window of "Exit the system" as shown in the
figure below:
Fig. 2-3-22
Click " " to exit the software system.
The exit can only be carried out under the offline status, and if the Analyzer is online, click " " first to go offline
and then exit the system.
(3) Switch the user: click " " to switch users and the display is as shown below:
Fig. 2-3-23
● When the testing doctor is having a rest, it is recommended to exit the software to prevent nonusers from
destroying the software or modifying data. Users are recommended to back up the database regularly to
prevent accidental data loss.
● After the initial user name and password are input for the first-time login, set the user name, password and
access right in the "User information" of "System management" for the next login.
The Analyzer will be under the standby status 40 minutes after the power source connection (waiting for the
temperature and the light source to be stabilized).
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2.3.8 Commissioning of the Analyzer

Conduct following operations on the System maintenance interface in the sequence below.
(1)ISE syringe pump exhaust
Execute ISE syringe pump exhausts to exhaust the air in the tubing. See "10.2.3 Air exhaust" for specific operation
method.
(2) Probe horizontal check
Confirm that the probe is at the correct position above the cuvette, rinsing bath, sample reagent disk outer circle,
sample reagent disk middle circle, sample reagent disk inner circle, ISE adding position (with ISE module). See
"10.2.5 Mechanism check" for specific operation method.
(3) Mixing bar horizontal check
Confirm that the mixing bar is at the upper position of the cuvette and the rinsing bath by the mixing bar horizontal
check. See "10.2.5 Mechanism check" for specific operation method.
(4) Mechanical motions check
Execute 20 mechanical motions checks to confirm if the wiping block on the nozzle of the rinsing mechanism
abrades the cuvette and if each mechanism operates normally. See "10.2.5 Mechanism check" for specific operation
method.
(5) Rinsing cuvettes and ISE
Rinse cuvettes via the window of "System maintenance" and see "10.2.4 Rinsing" for specific operation method. To
configure ISE device, carry out rinsing ISE tubing and rinsing ISE cuvette maintenance operations on ISE
maintenance interface and see "10.2.7 ISE" for specific operation method.
(6) Light intensity check
Execute the light intensity check and attach the result in the acceptance report. The light check value shall be less
than or equal to 18000. See "10.2.2 Cuvette blank and light intensity check" for specific operation method.
(7) Cuvette blank test
Execute the cuvette blank test, and the cuvette blank test value of Cuvette 1 shall be in the range of 8000-18000, and
the difference between other cuvettes and Cuvette 1 in blank shall be in the range of -1500~1500. See "10.2.2
Cuvette blank and light intensity check" for specific operation method.
(8) ISE check
Execute 50 ISE checks on the "System Maintenance" window. The difference between two adjacent values of the
test results shall not be more than 0.2 mV. See "10.2.7 ISE" for specific operation method.
2.3.9 Test of clinical items
Edit chemical parameters, register reagent information, test rate assay ALT and endpoint assay TP and two-point
rate assay UREA, calculate coefficient of variation and fill the test results in Installation Acceptance Report.
2.3.10 Training for medical personnel
Conduct training on the operation and maintenance of the Analyzer for medical personnel and record the training in
Installation Acceptance Report.
2.3.11 Fill-in of installation acceptance report
Fill in the Installation Acceptance Report completely and send one copy to AGAPPE or the local distributor.
2.4 Barcode reader of the sample reagent disk

2.4.1 Scanning range of barcode reader
The internal barcode reader (optional) can simultaneously scan the outer circle and inner circle of the sample reagent
disk. When scanning the inner circle, the inner circle reagent disk or tube needs to be removed.
2.4.2 Requirements for sample container
(1)Specifications:
Test tube: Φ12mm×75mm, Φ12mm×100mm, Φ13mm×75mm, Φ13mm×100mm(±1 mm)
Standard cup: Φ14mm×37mm(±1 mm)
(2) The tube mouth shall be regular without extrusion or deformation.
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2.4.3 Requirements of reagent bottle

Specification: 70mL, 35mL and 20mL.
2.4.4 Requirements for sample barcodes use
(1)Barcode type: Code 128, Code 39, Code 93, Codebar, I2 of 5.
(2)Size of barcode label:
It is required the width of the barcode should be 8mm~12mm and its effective length should not be greater than
40mm. During the cutting, the start blank and end blank of the barcode shall not be smaller than 3mm as shown in
the figure below:
Barcode width
Effective length of
Start blank barcode End blank
Fig. 2-4-1
(3) See Table 2-4-1 for number of digits of different barcodes.
Table 2-4-1
Type of sample barcodes Number of identification digits
Code39 3~18
Code93 3~18
Code128 3~18
I2of5 3~18
Codebar 3~18
2.4.5 Requirements for reagent barcodes use

(1) Barcode type: code 128 (17 bit).
(2) Size of barcode label: it is required the width of the barcode should be 12mm~25mm and its effective length
should not be greater than 40mm (as shown in Fig. 2-4-1).
(3) During the cutting, the start blank and end blank of the barcode shall not be smaller than 3mm (as shown in Fig.
2-4-1).
● Codebar must be prefixed and suffixed with A, B, C or D and the barcode shall not have characters such as
' ', " " and ( ), or it cannot be normally identified.
● The length of barcode suffixed with NR shall not be less than 5.
2.4.6 Requirements for pasting barcode labels
(1) Barcode label shall be pasted in a flat manner without crumple and pollution and the print of barcode lines cannot
be incomplete as this may lead to incorrect reading.
(2) Pasting of barcodes
The lower edge of the barcode shall be 15mm~20mm from the tube bottom to ensure correct reading of the barcode.
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When the test tube is inserted in the sample, reagent disk test tube rack, it shall be ensured the barcode faces the
opening of the sample position. The pasting method of sample barcodes is shown in the figure below:
Fig. 2-4-2 Pasting of sample barcodes
The ID number on the screen after the scanning or on the report shall be added with "+" before the
corresponding capital letters if the barcodes are small in Code 39.
2.4.7 Use of barcode reader
If "Sample barcode number" is selected under sample test mode on "Other information" interface of the "System
Setting" window before the analysis, the sample, reagent disk will stop rotating at the position of the barcode reader
after the test is started and the barcode reader will read the barcode according to the set sample position. The reader
will scan for three times if the barcode cannot be read during the scanning. Sample tests cannot be conducted during
barcode scanning and the tests can only be conducted after the scanning. The sample, reagent disk will turn to the
reading position of the barcode reader to conduct barcode scanning after the probe finishes dispensing samples.
After scanning barcodes, the sample, reagent disk will return to the dispensing position to continue the sample
dispensing. The scanned information will display on the windows of "Sample registration" and "Test result".
During the sample reagent disk barcode reader check on the "System maintenance" window, the barcode reader
identifies barcode information of samples at reagent disk position 1, outer 1, and inner 2, and a prompt of success or
failure is then given after the scanning.
Only after the barcode is pasted at the opening of the sample, reagent disk for the test tube to be pasted with barcode
can the barcode be identified.
2.4.8 Rule of reagent barcodes
Users may prepare the barcode numbers as the case may be. The rule is as shown in Table 2-4-2:
Table 2-4-2
Barcode Barcode Scope of barcode
Detailed explanations of barcodes Note
digit information value
Item code of biochemical reagent
0~94 (representing different item names)
95 ISE Internal Standard Solution
96 ISE Diluent
1~2 Item name
97 ISE Reference Solution
CXL Pro anti-bacterial phosphor-free
98 detergent
99 CXL PROalkaline detergent
1 20mL
2 70mL
3 100mL
4 500mL
Bottle
3
specification 5 2000mL
6 5000mL
7 150mL
40mL(CXL PRO)
8 35mL(MISPA CXL PRO)
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Barcode Barcode Scope of barcode

Detailed explanations of barcodes Note
digit information value
1 R1
2 R2
3 R3
4 Reagent types
4 R4
The reagent type must be 5 if
5 None the item code is ISE reagent or
CXL Pro detergent.
0~9 Year
Date of
5~9 manufacturer 01~12 Month
(Lot No.)
01~31 Day
1 2 weeks
2 1 month
3 3 months
4 6 months
10 Validity 5 12 months
6 18 months
7 2 years
8 3 years
9 5 years
11~14 Bottle code 0001~9999 Bottle No. (bottle XXXXX)
Number or letters
15~17 Check bit (automatically
generated)
The reagent barcode information is read by the barcode reader, and coupled with parameters of all analysis items
already saved by the Analyzer. This process is called reagent automatic registration. That is to say, the relevant
reagent information can be determined by barcode scanning.
The information which has already been read will display on "Reagent information" window in forms of "Disk No.",
"Position", "Reagent name" and "Type".
Reagent name: the chemical names of analysis items.
Reagent position: there are outer 01~40 positions on sample reagent disk middle circle (when executing system
maintenance, outer position 01 defaults to CXL PRO anti-bacterial phosphor-free detergent; when executing cross-
contamination avoidance, it’s required to register the detergent position in the “Reagent Registration” window ) to
place reagent for automatic barcode scanning. There are 01~40 positions on the inner circle. Automatic barcode
scanning is not available for reagents on sample reagent disk inner circle under the condition that the middle circle is
filled with reagent and the reagent information can only be manually registered.
The reading window of the barcode readers of sample and reagent disks shall be regularly cleaned.
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Chapter 3 Software operation
3.1 Software interface description

3.1.1 Window composition
Software interface is composed of status bar, functions area, working area, prompt bar and shortcut keys area.
(1) Status bar: it displays the status of the Analyzer in real time at the uppermost part of the main window. The
information displayed on the status bar is real-time displayed information as shown in Fig. 3-1-1:
Fig. 3-1-1
Function description:
: display operating temperature and status in real time. The status includes
standby, testing, emergency stop, sample dispensing suspension, various maintenance actions and system sleep, etc.
: LIS status. If it is displayed, it means LIS is enabled and if it is not displayed, it means LIS is disabled.
: communication monitoring mark. It means normal connection if there is a ball and it means connection failure
if there is no ball.
: Analyzer alarm prompt icon. The icon does not appear on status bar if there is no alarm message given at the
Analyzer. Only when an alarm is given can the icon appear on the status bar. By clicking the shortcut key F8 (alarm
message) or the alarm prompt icon, the operator can check the alarm message and then handle the abnormality
according to the prompts.
: display ID information of current login user. The information can be set, changed or deleted on tag
"User information" of "Information management" under the window of "System management".
: display computer system time ((time) (accurate to seconds) on (date) day of the
week).
(2) Functions area: click to select function key and the color of the frame of the clicked key changes and the display
is as shown in the figure below. Click " " and change the window color and style.
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Fig. 3-1-2
(3) Working area: click corresponding function key to go to working area window for specific operation and the
color of the frame of the clicked key changes. Click "Setting" in the Function Guide area and the display is as shown
below:
Fig. 3-1-3
(4) Prompt bar: the prompt bar is located at the lower left part of the interface, which provides users with
corresponding prompts for most operations to help users to quickly understand and master the use of the software.
For example, the prompt of input range and method or operation error given as shown in the figure below:
Fig. 3-1-4
(5) Shortcut key (auxiliary key) area: several common function keys are placed in the shortcut key area of the
software to facilitate the user to operate the software as shown below:
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Fig. 3-1-5
You can use the mouse to click corresponding key, and you can also directly press key "F2" ~ "F8" on the keyboard.
"F1" by default is the software help key.
Click the space in front of the "Instrument status" and the software version information is displayed.
3.1.2 Keyboard function
(1)Num-lock key (Num Lock)
It can be used to check whether the numeric keypad turned on.
(2)Caps-lock key (Caps Lock)
It can be used to switch the input of capital and lower-case letters.
(3)Common shortcut key
F1: system help shortcut key
F2: send test shortcut key
F3: sample dispensing suspension (continuing) shortcut key
F5: emergency stop shortcut key
F6: online/offline shortcut key
F7: exit system shortcut key
F8: alarm information shortcut key
3.1.3 List of software function keys
Table 3-1-1
Sample Edit sample information, patient information, test item information, sample summary table and manual
registration application for LIS
Result query Modify results, add items and reaction curve, send data to LIS, audit, print
Query history Data query and results comparison

Test result
Result statistics Repeatability statistics, result positive statistics, item statistics and workload statistics
Item review Recheck condition setting and recheck batch registration
Reagent Reagent information setting, reagent information printing, reagent residual volume scanning
Reagent registration and reagent barcode scanning
information Reagent
Reagent information condition monitoring and printing
browse
Calibration Type and item of registration calibration, calibration information deletion and setting of
registration standard solution concentration and position
Calibration Calibration Calibration curve, calibration tracing, reaction process, calibration data, historical
information results calibration results
ISE calibration parameters setting, ISE calibration results view, ISE calibration results
ISE calibration
printing and historical calibration results
QC registration QC rule editing, QC item registration, QC position setting and QC dilution setting
QC
Daily QC Reaction curve, QC chart, QC deletion, monthly QC accumulation, historical QC results
management
Monthly QC QC icon, QC results printing, QC deletion and results edition
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Item
Item information registration, addition, modification, deletion and printing
maintenance
Item parameter Analysis parameters, calibration parameters and range of parameters
Serum
Serum information setting
information
Portfolio Portfolio editing
Calculation
System
and Item calculation and setting of compensation item
setting
compensation
Cross
Setting of probe, cuvette to avoid cross contamination
contamination
Report sheet
Report sheet information and printing format setting
format
Other
Sample test mode, ISE setting, reagent alarm setting, sample probe rinsing alarm setting
Information
LIS
LIS communication setting
communication
Information
User information, hospital information and other information setting
System management
management
System log Login log, operation log, maintenance log and alarm log view
Instrument
Probe mechanisms return to zero position
reset
Cuvette blank
and quantity of Cuvette blank maintenance and test, light intensity check
light
Air exhaust Syringe pump exhaust
system
maintenance Rinsing Cuvette and probe
Mechanism
Probe, mixing mechanism and mechanical action
inspection
Barcode Barcode check
Sleep Sleep status setting

Sample
disk/reagent Sample disk/reagent disk status
disk
Reaction disk Reaction disk status
System
monitoring LIS status LIS communication status
Test pattern Sample test list

Instrument
Status of system mechanisms
status
3.2 How to operate software

Click on the mouse to select software function keys and input values and words along with the keyboard (the input
method depends on Windows system and it can be switched by pressing Shift+Ctrl).
3.2.1 Cursor movement
The cursor will move once an input area or item is clicked.
3.2.2 Key selection
Click on the mouse to select the key needed.
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3.2.3 Window opening

Click the Windows key to open a window. The windows can be divided into modal window and non-modal window.
Modal window: other windows cannot be operated before this type of window is closed. Click "
" to close the window. For example, the "Patient Info" window in "Sample registration", as
shown in the figure below:
Fig. 3-2-1
Non-modal window: after the window is opened, other windows can still be operated without exiting the window,
such as "Analysis parameters" window of "Item parameters" under "System Setting" and the display is as shown
below:
Fig. 3-2-2
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3.2.4 Operation of list box and scroll bar

(1) List box
The frame that displays a part of the information is called list box. The information required among displayed
contents can be found out and selected by using the list box, as shown in the figure below:
Fig. 3-2-3
(2) Scroll bar
The scroll bar is used to adjust the display range of contents in list box. The scroll bar is generally divided into
vertical scroll bar (at the right corner of the list box) and transverse scroll bar (at the lower corner of the list box), as
shown in Fig. 3-2-3.
To check the contents displayed in list box, you can click " " or drag " ".
3.2.5 Operation of pull-down menu
Click the " " at the right side of the pull-down menu to open or close the pull-down menu. Pull-down menu can be
used to display more information. Once a required item is selected, the selected item will be displayed at the
uppermost bar and the pull-down menu will disappear.
3.2.6 Option button and check box
Option button: it means only one function will be selected among several functions. For example, for the selection
of "Sample volume" on the "Sample registration" window, you can only select "Normal", "Increment" or
"Decrement" but cannot select them all, as shown in the figure below:
Fig. 3-2-4
Check box: it means two or more functions can be selected simultaneously. For example, on the "Portfolio"
interface, several items can be selected simultaneously, and the display is as shown in the figure below:
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Fig. 3-2-5
3.2.7 Grid table width adjustment
The width of most tables in the software can be adjusted according to the requirements. Go to the interface after the
change is made and the original table width will be recovered.
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Chapter 4 System management
4.1 Information management

Only the user with administrator permission can add, delete or modify the user information.
Click " " in the functions area to enter the system management window and the display is as
shown below:
Fig. 4-1
4.1.1 User information
Click " " on the "System management" window and go to tag " " and the display is as shown
below:
Fig. 4-1-1
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(1) User: input the user name in the input box.

(2) Password: input the corresponding password of the user name in the input box.
(3) Confirm password: input the password consistent with that set in "Password" setting area and ensure the two
passwords input must be consistent.
(4) Permission: select the applicable permission of the user from the "Permission" pull-down menu:
a) Query permission: select "Query" from the pull-down menu and the user can only view certain function window
and is not allowed to set and test the functions or conduct online operation.
b) Operation permission: select "Operation" from the pull-down menu, and the user can only set and check all the
functions except the user information and system setting and the user can register, modify or delete own test
sample records.
c) Administration permission: select "Administration" from the pull-down menu, and the user can set, delete and
view all functions and conduct tests.
(5) Mnemonic: the mnemonic can help users input the information quickly. For example, the mnemonic of user can
be set as JXL or in figures, like 001. Input mnemonic to log in at the login area.
Input relevant information in the figure and click " " and the user information is successfully set
and the edit information is displayed in the working area; to delete the user information, click on the mouse to select
the user information in the working area and then click " ". Click " " to exit
"User information" window.
4.1.2 Hospital information
Click tag " " to set sending department, sending doctor, inpatient and ward, and the display is as
shown below:
Fig. 4-1-2
Input relevant information in the figure and click " " and the information is successfully set and
the edit information is displayed in the working area; to delete the information, click on the mouse to select the
information in the working area and then click " ". Click " " to exit the
window.
These items will be listed in corresponding pull-down menu of "Patient information" after they are successfully set.
4.1.2.1 Sending department
Click " " to set the sending department name and mnemonic.
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(1) Sending department: input the sending department name in the input box.
(2) Mnemonic: input the mnemonic of sending department in the input box. The mnemonic can help users input the
information quickly. For example, the mnemonic of sending department can be set as WGK or in figures, like 001.
4.1.2.2 Sending doctor
Click tag " " to set sending doctor name, sending department and mnemonic, and the display is as
shown below:
Fig. 4-1-3
(1) Sending doctor: input the sending doctor name in the input box.
(2) Sending department: select the sending department from the pull-down menu.
(3) Mnemonic: input the mnemonic of sending doctor in the input box. The mnemonic can help users input the
information quickly.
4.1.2.3 Inpatient area
Click the " " to add or delete an inpatient area, and the display is as shown below:
Fig. 4-1-4
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(1) Inpatient area: input the inpatient area name in the input box.
(2) Mnemonic: input the mnemonic of section in the input box. The mnemonic can help users input the information
quickly.
4.1.2.4 Ward
Click the " " to add or delete a ward, and the display is as shown below:
Fig. 4-1-5
(1) Ward: input the ward name in the input box.
(2) Mnemonic: input the mnemonic of ward name in the input box. The mnemonic can help users input the
4.1.3 Other information
Click " " to set the patient type, clinical diagnosis, remarks, item unit and nationality.
Input relevant information in the figure and click " " and the information is successfully set and
the edit information is displayed in the working area; to delete the information, click on the mouse to select the
information in the working area and then click " ". Click " " to exit the
window.
These items will be listed in corresponding pull-down menu of "Patient information" after they are successfully set
(item unit will be listed in corresponding setting interface).
4.1.3.1 Registration type
Click the " " to set the patient type and mnemonic, and the display is as shown below:
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Fig. 4-1-6
(1) Patient type: input the patient type in the input box.
(2) Mnemonic: input the mnemonic of registration type in the input box. The mnemonic can help users input the
4.1.3.2 Clinical diagnosis
Click the " " to set the clinical diagnosis and mnemonic, and the display is as shown below:
Fig. 4-1-7
(1) Clinical diagnosis: input the clinical diagnosis information in the input box.
(2) Mnemonic: input the mnemonic of clinical diagnosis in the input box. The mnemonic can help users input the
4.1.3.3 Remarks
Click " " to set the report remarks and mnemonic, and the display is as shown below:
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Fig. 4-1-8
(1) Remark: input the remark of relevant information in the input box.
(2) Mnemonic: input the mnemonic of remarks in the input box. The mnemonic can help users input the information
quickly.
4.1.3.4 Item unit
Click the " " to set the item unit, and the display is as shown below:
Fig. 4-1-9
Item unit: input the relevant letters of item unit in the input box. After the information is added, it can be selected
from the pull-down menu of the relevant information input area.
4.1.3.5 Nationality
Click " " to set the nationality information and mnemonic, and the display is as shown below:
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Fig. 4-1-10
(1) Nationality: input the nationality name in the input box.
(2) Mnemonic: input the mnemonic of nationality name in the input box. The mnemonic can help users input the
4.2 System log
Click the " " on the "System management" window, and the display is as shown below:
Fig. 4-2-1
System log includes login log, operation log, maintenance log and alarm log.
Select a log type from "Log type" pull-down menu and select the start date and end date from "Query date" pull-
down menu, and the log information meeting the requirements will be displayed in the working area.
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Select a certain log from the log list box and click " " to delete the log content.
Click " " to delete all the log information displayed in current log list.
Click " " to print current log list.
Click " " to exit the current window
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Chapter 5 System setting
Click " " in the functions area to go to system setting window and the "System Setting" window
includes item maintenance, item parameters, serum information, item combination, calculation and compensation,
cross-contamination, report format, other information and LIS communication and the display is as shown below:
Fig. 5-1 System Setting Interface
5.1 Item maintenance
Click " " on the "System Setting" window to enter the item maintenance window, select tab
and the display is as shown below:
Fig. 5-1-1
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The addition of a new item can be set in the working area of "Item information".
: print all information in item maintenance;
: the information of new item clicked is added in the working area list;
: click on the mouse to select an item, and then click the button to delete the item;
: click on the mouse to select an item, modify the item information and then click the button,
and the modified information is saved and displayed in the item list;
: click the button to exit the window.

5.1.1 Addition of colorimetric item
(1) Item type: select "colorimetric item" from the pull-down menu and the display is as shown below:
Fig. 5-1-2
(2) Item number: input the number of new item in the input box, such as 25; the number of colorimetric item cannot
be empty or repeated with existing information.
(3) Item abbreviation: input the short name or abbreviation of the new item in the input box, such as ALT; the
abbreviation of colorimetric item cannot be empty or repeated with existing information.
(4) Barcode number: during the automatic registration of reagent information, namely when the reagent barcode
registration method is used, barcode number is the item number used to identify item name and 01~99 respectively
represents different item names; the barcode number of colorimetric item may not be input but it cannot be repeated
with existing information.
(5) Full name of the item: input the full name of the item in the input box, such as alanine aminotransferase, full
name of ALT; the full name of colorimetric item may not be input but it can be repeated with existing information.
(6) Printing order: set the order of the items in the print report; the default printing order of colorimetric items is the
same as the item number, and it cannot be empty but it can be repeated with existing information.
5.1.2 Modification of serum index
(1) Item type: select the "Serum index" from the pull-down menu.
(2) Item number: the item number of serum index is fixed and it cannot be changed.
(3) Item abbreviation: the item abbreviation of serum index is fixed and it cannot be changed.
(4)Barcode number: the barcode number of serum index is fixed and it cannot be changed.
(5) Full name of the item: input the full name of the item in the input box; the full name of serum index may not be
input but it can be repeated with existing information.
(6) Printing order: set the order of the items in the print report; the default printing order of serum indexes is the same
as the item number, and it cannot be empty but it can be repeated with existing information.
5.1.3 Modification of ion item
(1) Item type: select the "Ion item" from the pull-down menu.
(2) Item number: the item number of ion item is fixed and it cannot be changed.
(3) Item abbreviation: the item abbreviation of ion item is fixed and it cannot be changed.
(4)Barcode number: the barcode number of ion item is fixed and it cannot be changed.
(5) Full name of the item: input the full name of the item in the input box; the full name of ion item may not be input
but it can be repeated with existing information.
(6) Printing order: set the order of the items in the print report; the default printing order of ion items is the same as
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the item number, and it cannot be empty but it can be repeated with existing information.
5.1.4 Addition of manual item
(1) Item type: select the "Manual item" from the pull-down menu.
(2) Item number: input the number of new item in the input box, such as 25; the number of manual item cannot be
empty or repeated with existing information.
(3) Item abbreviation: input the short name or abbreviation of the new item in the input box; the abbreviation of
manual item cannot be empty or repeated with existing information.
(4) Barcode number: the barcode number of manual item is not available.
(5) Full name of the item: input the full name of the item in the input box; the full name of manual item may not be
input but it can be repeated with existing information.
(6) Printing order: set the order of the items in the print report; the default printing order of manual items is the same
as the item number, and it cannot be empty but it can be repeated with existing information.
5.1.5 Print sequence
Click tab " " as shown below:
Fig. 5-1-3
Select an item from the list, and adjust the print sequence of the items by clicking the buttons on the right of the
interface.
5.2 Item parameters
Click the " " icon on the "System Setting" window to enter the item parameter setting window where the
item analysis parameters, calibration parameters and range parameters can be set.
After the parameters on each page are edited, the operator must click " " to save the
parameters.
5.2.1 Analysis parameters of colorimetric item
Set the wavelength, reagent volume, sample volume, analysis method, metering points, decimals, item unit and
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other parameters on the "analysis parameter" interface.

5.2.1.1 Setting of analysis parameters
Click " " to set the analysis parameters of colorimetric item, and the display is as shown below:
Fig. 5-2-1
Select the item name whose parameters are about to be set from the "Item list" on the left side of the working space
and set relevant analysis parameters on the right item by item:
(1) Decimal place: select the test result decimals from the pull-down menu and the results printed and displayed will
remain as per the set decimals.
(2) Item unit: select chemical item unit from the pull-down menu and see "4.1.3.4 Item unit" for the unit addition and
deletion.
(3) Reagent blank: click to select reagent blank " ". During testing, reagent blank test will be
executed.
(4) Test method: select a method meeting the reagent test requirements from the pull-down menu and see "5.2.1.3
Analysis method type" for specific introduction of 1-point endpoint assay, 2-point endpoint assay, rate A assay and
2-point rate assay.
(5) Point: the Analyzer records the absorbance value approximately every 20 seconds, namely 1 metering point
corresponds to 20 seconds. Input proper metering points according to the reagent instruction, and effective metering
point shall be input within 2~40 (0 represents no input). The measured absorbance value at each metering point can
be checked in sample reaction curve.
(6) Main/sub-wavelength: the pull-down menu lists 12 wavelengths for selection: 340 nm, 380 nm, 405 nm, 450 nm,
480 nm, 505 nm, 546 nm, 570 nm, 600 nm, 660 nm, 700 nm, 800 nm. Select the main wavelength and sub-
wavelength according to the reagent instruction requirements. If double wavelength test is conducted, when the
Analyzer calculates the results, the absorbance difference of main wavelength and sub-wavelength or difference of
absorbance change rate is used to calculate the results. When the single wavelength is tested, sub-wavelength is
selected as "0".
(7) Device factor (Y = aX + b): this is used for relationship calibration to validate that the test results of the Analyzer
are consistent with those of other analyzers. For the inspection of some items, the test results of the Analyzer can be
above or below the expected results or acquired results of other analyzers. To ensure the test results are consistent
with the expected results or results of the other analyzers, the correction relationship is added in the result
calculation. The relationship equation is:
Y  aX  b
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Where: Y is the corrected result

X is the actual result obtained from the Analyzer
a is the slope value (multiplication correction factor)
b is intercept value (compensation correction factor)
When the test results of the Analyzer are the same as the expected results or the results obtained from two analyzers
are consistent, ensure a=1, b=0.
When the results obtained from two analyzers are inconsistent, correction can be made through slope value and
intercept value to obtain consistent results. Slope value "a" is a positive number smaller than 100000000 and the
intercept value "b" is a real number smaller than 100000000.
(8) Sample volume
a) Sample type: click to select the sample type to be used.
b) Sample volume: sample volume includes normal volume, decrement and increment. The display is as shown in
the figure below:
Fig. 5-2-2
Normal volume:
Normal volume is set to define the normal volume of the sample. The input contents include 3 input boxes which
respectively are sample volume for analysis, sample volume for dilution and diluent volume.
[Normal volume/ sample volume for analysis]: this is the sample volume obtained from the sample container
(standard cup or tube) and the input values are between 2μL~35μL. The total volume of sample and reagent shall
be greater than or equal to 100μL and smaller than or equal to 360μL.
[Normal volume/ sample volume for dilution]: if the sample needs to be diluted, this parameter is used to set the
sample volume for dilution taken from the sample container and injected in the cuvette (standard cup or test tube),
and the input values are between 2μL~35μL. When the sample does not need to be diluted, input "0" here.
[Normal volume/diluent volume]: if the sample needs to be diluted, the parameter is used to set the volume of
diluent diluting the sample. The input values are between 35μL~300μL. When the sample does not need to be
diluted, input "0" here.
Decrement (sample volume reduced):
Decrement is set to define the sample volume needed (below normal volume) when the sample concentration
exceeds the upper limit of the reagent linear range and this part includes 3 input boxes which respectively are
sample volume for analysis, sample volume for dilution and diluent volume. After the test, the Analyzer
automatically converts the test result of the decrement into normal volume and displays it in the result information.
[Decrement/ sample volume for analysis]: this is the sample volume obtained from the sample container (standard
cup or tube) and a volume less than the normal volume and between 2μL~35μL is selected. The total volume of
sample and reagent shall be greater than or equal to 100μL and smaller than or equal to 360μL.
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[Decrement/ sample volume for dilution]: if the sample needs to be diluted, this parameter is used to set the
sample volume for dilution taken from the sample container and injected in the cuvette (standard cup or test tube),
and the input values are between 2μL~35μL. When the sample does not need to be diluted, input "0" here.
[Decrement/diluent volume]: if the sample needs to be diluted, the parameter is used to set the volume of diluent
diluting the sample and the input values are between 35μL~300μL. When the sample does not need to be diluted,
input "0" here.
Increment (sample volume increased):
Increment is set to define the sample volume needed (above the normal volume) when the sample concentration is
less than the lower limit of the reagent linear range and this part includes 3 input boxes which respectively are
sample volume for analysis, sample volume for dilution and diluent volume. After the test, the Analyzer
automatically converts the test result of the increment into normal volume and displays it in the result information.
[Increment/ sample volume for analysis]: this is the sample volume obtained from the sample container (standard
cup or tube) and a volume greater than the normal volume and between 2μL~35μL is selected. The total volume
of sample and reagent shall be greater than or equal to 100μL and smaller than or equal to 360μL.
[Increment/ sample volume for dilution]: if the sample needs to be diluted, this parameter is used to set the sample
volume for dilution taken from the sample container and injected in the cuvette (standard cup or test tube), and the
input values are between 2μL~35μL. When the sample does not need to be diluted, input "0" here.
[Increment/ diluent volume]: if the sample needs to be diluted, the parameter is used to set the volume of diluent
diluting the sample and the input values are between 35μL~300μL. When the sample does not need to be diluted,
input "0" here.
The sum of sample volume for dilution and diluent volume must be greater than the sample volume for
testing. When sample volume for dilution, 2μL≤S<35μL, the sum of sample volume for dilution and diluent
volume must be ≥100μL; when sample volume for dilution, S=35μL, the sum of sample volume for dilution
and diluent volume must be ≥70μL.
(9) Absorbance limit: please input absorbance check range in the input box and select positive reaction or negative
reaction from the pull-down menu.
For analysis item by rate-A assay and 2-point rate assay, when the concentration is beyond the set quantitative range,
correct data cannot be obtained. Therefore, set the upper limit or lower limit of the absorbance for check and give
alarm prompt. Input the check value in the input box of "Absorbance limit" on the window of "Analysis parameter"
and if check is not to be conducted, input 0 (negative reaction) or 3.3 (positive reaction).
When 4 or more measured absorbance values do not meet the set values of absorbance limit, an alarm is given and
the display is as shown below:
Fig. 5-2-3
(10) Prozone check: please input prozone check range values in the input box and select upper limit or lower limit
from the pull-down menu.
In the immune response, when the antigen concentration in the samples is beyond the quantitative range, reaching
the abnormally high value, the standard curve will tent to decline instead. We call this phenomenon as cellula
phenomenon. The Analyzer can check whether the tested concentration is in the field where absorbance declines.
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Method for prozone check can be divided into antigen re-dispensing and reaction speed ratio. Described respectively
in Fig. 5-2-4(a) and Fig. 5-2-4(b).
a) Antigen re-dispensing
It is applicable to 1-point assay. Start analysis after dispensing reagent n-1, and dispense a small quantity of (about
50μL) sample with antigen like diluted serum, and compare the absorbance difference between reagent n-1 and
reagent n (PC value) with the input value (LIMIT), n=2.
Fig. 5-2-4(a) Prozone Check (take antigen re-dispensing as example)

Wherein: AL: absorbance at the light measuring point L.
 Input the range, upper limit and lower limit of prozone check in parameter analysis interface: if the value of
prozone check is higher than the upper limit or lower than the lower limit, a data alarm will be given.
 Method of prozone check
 Compare prozone check value (PC) with the limit value:
Am  A m1 A  A L1
PC  k L
2 2
 wherein: m and L refer to light measuring point, and k refers to calibration coefficient. But, when 1≤L, m≤5
or 6≤L, m≤16 or 17≤L, m≤33, 34≤L, k=1.
b) Reaction speed ratio
It is applicable to 2-point endpoint assay. Compare the ratio (PC) of the reaction speed rate after dispensing
reagent n to the overall response speed rate from dispensing reagent n to the absorbance measuring point with the
input value (LIMIT). N=2.
Fig. 5-2-4(b) Prozone Check (take reaction speed ratio as example)
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Wherein: ΔAn·p and ΔAn·m respectively refer to the average reaction speed between light measuring point n and p,
and between the point n and m.
 Input the range, upper and lower limit of prozone check on the parameter analysis interface.
 Method of prozone check
 Compare prozone check value (PC) with the LIMIT value:
Am  An
PC  m  n 100
Ap  An
pn
 Description: do not conduct prozone check for calibration.

When prozone check is not to be implemented, please input"-3.3 lower limit" in check value.
(11) Diluent type: refers to the diluent type used for diluting sample, which can be selected between water and diluent
from the pull-down menu. Water refers to the pure water discharged from the inner wall of probe; diluent refers to
the type selected by users, such as normal saline and buffer, which is placed in sample reagent disk and whose
position can be set in reagent information. When sample dilution test, multi-point linearity calibration or non-
linearity calibration is conducted, the probe will automatically aspirate diluent in the sample reagent disk.
(12) Always dilution: select " ", and all samples of the item will be diluted during test.
(13)Reagent: reagent includes R1 and R2 as shown below:
Fig. 5-2-5
a) Reagent volume: refers to the volume of reagent dispensed during test, and the unit is μL. A probe can aspirate
10μL~300μL of reagent with the stepping of 0.1μL. "0" refers to not dispense reagent.
b) Diluent volume: if concentrated reagent is used, the diluent volume for diluting the concentrated reagent can be
input in "Diluent volume" input box. The volume shall be not larger than 250μL, and the total volume of reagent
and diluent shall be not larger than 360μL.
(14) Open-bottle life ( /d): input the open-bottle life (unit: /d) in the input box within 0-999. After the setting of open-
bottle life, it starts to count from the current date, and the expiry date is shown on "Expiry date" list on "Reagent
registration" window of "Reagent information". If the open-bottle life of the reagent expires, an alarm prompt will
be given each login of the software.
(15) Dilution plan: click " " below "Parameter analysis" interface as shown below:
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Fig. 5-2-6
a) Input the name of dilution plan in the "Dilution Plan" input box.
b) Select item to be diluted form the "Item Abbr." pull-down menu.
c) Select the sample type for the dilution item from the "Sample Type" pull-down menu.
d) Select sample volume type in "Sample Volume".
e) Input sample volume used for dilution in "Sample Volume for Dilution" within 2μL~35μL.
f) Input diluent volume in the "Diluent Volume" input box within 35μL~300μL.
Multiple dilution plans can be set for the same item. Select " " on the sample registration interface, then
select "Item abbreviation" and a dilution plan already set of the item will automatically pop up.
(16) Hemolysis inside machine
When testing HbA1c, if you do not choose "hemolysis inside", you need to manually pretreat the whole blood
sample. The processed sample can be placed in the sample reagent disk for testing.
When testing HbA1c, if you select "hemolysis inside" and select the applicable Lyse type from the drop-down menu
of Lyse type and also register the Lyse information on the "Reagent Information" interface, place the Lyse in the
corresponding position of the sample reagent disk before testing. When testing HbA1c, the analyzer automatically
performs sample pretreatment and then tests.
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Fig. 5-2-7
(17) Linearity check: In the reaction of Rate A method, the change in absorbance should be linear with the time.
Therefore, the linearity needs to be checked. When the limit is exceeded, an alarm is issued. Set as shown in
Figure 5-2-1, " " indicates selection, and enter the limit check value in the corresponding text box:
Fig. 5-2-8
" " means unchecked. Even if you enter a value in the corresponding text box, the analyzer will not perform a linear
check of the reaction.
a) When the range of the photometric point is above 9 (N≥9)
The principle of the linear check is to use the least squares method. When N≥9, the linearity check is performed
by dividing the difference between the absorbance changes at each part of the first 6 points and the last 6 points
by the average value of all the absorbance change rates. If the value obtained exceeds the linear check value, an
alarm is issued. Figure 5-2-9 shows the schematic diagram of linear check when N≥9.
Fig. 5-2-9 Linear check N≥9

b) When the range of the photometric point is 4 to 8 (4≤N≤8)
When 4≤N≤8, the linearity check is performed by dividing the difference between the absorbance changes of the
first 3 points and the last 3 points by the average value of all the absorbance change rates. If the value obtained
exceeds the linear check value, an alarm will occur. Fig. 5-2-10 is a schematic diagram of linear check
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when 4≤N≤8.
Fig. 5-2-10 Linear check 4≤N≤8

In case of the following conditions, do not perform a linear check:
 The number of photometric points within the reaction limit absorbance is within 3 points (N≤3).
 ΔA/ΔA′≤0.006 or∣Δaf-Δab∣≤0.006.
5.2.1.2 Detection principle
Analysis method based on the selective absorption of light, i.e. Beer-Lambert Law, is built for the Analyzer.
Its detection principle is: when monochromatic light with specific wavelength passes though the cuvette with
sample solution, the absorption intensity of the monochromatic light (absorbance) is in direct proportion to the
concentration of sample solution as well as the distance of light passing through the solution (optical path). Namely:
1 I 
A  lg  lg o  bc
T  
I
   t 
Including:
A- the absorbance of light absorbed by the solution when passing through
T- ratio of transmission intensity to incident intensity, i.e. light transmittance It/Io
I0- incident intensity
lt- transmission intensity
ε- molar absorption coefficient of solution (mL×mmol-1×cm-1)
c- molar concentration of solution (mmol/mL)
b- solution thickness (cm)
Solution thickness (b), i.e. optical path is fixed by the Analyzer and is known. Molar absorption coefficient of
solution (ε) is the coefficient related to wavelength, solution and solution temperature, when stable solution
temperature can be ensured, under its single wavelength, the solution concentration and the absorbance of the
solution are in linear relation (ε will be given in the reagent box by the manufacturer).
When the sample to be tested is a kind of solution distributed evenly, it will only absorb incident monochromatic
light rather than producing fluorescence, scattering or photochemical phenomenon, and during the absorbing,
matters in the solution with absorbency additivity will not interact. As a result, this condition totally conforms to
Beer-Lambert Law.
5.2.1.3 Types of analysis method
Please refer to reagent specifications for setting chemical parameter. Taking the reaction time of 10min as an
example as shown in the table below:
Analysis Analysis Light Formula for absorbance
Cuvette blank Note
methods item measuring point calculation
1-point L–0–0–0 B1  B 2  B 3 AL  AL1
ALB
endpoint assay 1＜L≤40 3 2
2-point
GLU
L–M–0–0 B1  B2  B3 AM  AM1  kAL  AL1
endpoint assay 1＜L＜M≤40 3 2
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Analysis Analysis Light Formula for absorbance

Cuvette blank Note
methods item measuring point calculation
L–M–0–0 AM  AM1 AL  AL1 t: time (min) between
2-point rate B1  B2  B3 
UREA 2 2 light measuring point
assay 1＜L＜M≤40 3
t L and M
L–M–0-0
1＜L＜M≤40 B1  B 2  B 3
Rate-A assay ALT OA(M-L)
3
L+2＜M
L, M, N, P, Q, R: light measuring point

Rn: volume of reagent n, n=1-4
B1, B2, B3: pass cuvette blank
(B1+B2+B3)/3: the mean of passing cuvette blank
AX: the absorbance at light measuring point X
OA(M-L): absorbance change per minute between light measuring point L and M
K: correction factor of liquid volume
a
S  R j
k j1
b
S   Ri
i 1
S: sample volume
Rj, Ri: reagent volume, a refers to the uncorrected reagent quantity, and b refers to the corrected quantity
● During light measurement of the Analyzer, the volume of reaction solution shall be not less than 100μL and
not more than 360μL.
●Please input "0" when light measuring point is not used.
(1)1-point endpoint assay
1- point endpoint assay is to, after dispensing sample and reagent, measure absorbance at 1 specific light measuring
point (the time when reaction is balanced) to calculate sample concentration. Reaction curve is shown in the figure:
Fig. 5-2-11 Reaction Curve of 1-point Endpoint Assay

a) Light measuring point: [L]- [0]- [0]- [0] (wherein: 1<L≤40)
b) Absorbance calculation: use the average absorbance of light measuring point L and L-1 for calculation, and the
formula is as shown below:
AL  AL1
Ax
2
c) Concentration calculation
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CX  K   AX  B  C1  IFA  IFB
B1~B3 refer to the pass of cuvette blank, and R1~R2 are the dispensing position of reagent. CX refers to the
concentration of sample to be tested. C1 is the concentration of standard solution 1 (reagent blank), and K is K
factor. B represents the absorbance of reagent blank, and IFA and IFBare constants of the Analyzer representing
the slope and intercept.
d) Analysis item: such as total protein (TP) and albumin (ALB).
(2)2-point endpoint assay
When the reaction of tested object does not start, select the first absorbance, and when its reaction approaches the
end or is balanced, select the second one, the absorbance difference between the two light measuring points is used
for calculating sample concentration. The assay is called 2-point endpoint assay, and its reaction curve is shown in
the figure:
Fig. 5-2-12 2-point Endpoint Assay

a)Light measuring point: [L]- [M]- [0]- [0] (wherein: 1＜L＜M≤40)
b)Absorbance calculation
Use the average absorbance of light measuring point L and L-1 for calculation, and the formula is as shown
below:
A X
AM  AM1  k  A L  AL1
2
Including:
a
S  R j
k j1
b
S   Ri
i 1
a: measure reagent quantity when at AL

b: measure reagent quantity when at AM
c)Concentration calculation
CX  K   AX  B  C1  IFA  IFB
B1~B3 refer to the pass of cuvette blank, and R1~R2 are the dispensing position of reagent. AX is the absorbance
difference between light measuring point L and M, and CX refers to the concentration of sample to be tested. C1 is
the concentration of standard solution 1 (reagent blank), and K is K factor. B represents the absorbance of standard
solution 1 (reagent blank), and IFA and IFB are the coefficient of the Analyzer representing the slope and
intercept.
d)Analysis item: such as creatinine of enzymic method (CRE).
(3)2-point rate assay
Select 2 light measuring points which are not initial reaction absorbance or the ending absorbance, and calculate the
absorbance difference between the 2 points in unit time for the later calculation of sample concentration. The assay
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is called 2-point rate assay and the reaction curve is as shown in the figure:
Fig. 5-2-13 2-point Rate Assay
a)Light measuring point: [L]- [M]- [0]- [0] (wherein: 1<L<M≤40)

The absorbance is worked out through dividing the difference between the average absorbance of light measuring
point L and that of L-1 by time, and the formula is as shown below:
 A M  A M 1    A L  A L1 
X A 2 2
t
Including:
t: time interval (minute) between light measuring point L and M
CX  K   AX  B  C1  IFA  IFB
B1~B3 refer to the pass of cuvette blank, and R1~R2 are the dispensing position of reagent. AX is the average
change of absorbance per minute of light measuring point L and M, and CX refers to the concentration of sample
to be tested. C1 is the concentration of standard solution 1 (reagent blank), and K is K factor. B represents the
absorbance of reagent blank, and IFA and IFB are constants of the Analyzer to show the slope and intercept.
d)Analysis item: such as urea (UREA), creatinine of jaffe method.
(4)Rate-A Assay
Rate-A assay is a measurement method to calculate concentration or activity value by the change rate of absorbance
per minute between two light measuring points, and the reaction curve is shown in the figure:
Fig. 5-2-14 Rate-A
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a)Light measuring point: [L]- [M]- [0]- [0] (wherein: 1<L<M≤40, L+2<M)
Work out the change rate of absorbance per minute between light measuring point L and M by least square
method.
AX  AM L
c) Concentration calculation 
CX  K   AX  B  C1  IFA  IFB
B1~B3 refer to the pass of cuvette blank, and R1~R2 are the dispensing position of reagent. OA(M-L) is the average
absorbance change per minute between light measuring point L and M, and CX refers to the concentration of
sample to be tested. C1 is the concentration of standard solution 1 (reagent blank), and K is K factor. B represents
the absorbance change of standard solution 1 (reagent blank), and IFA and IFB are constants of the Analyzer
representing the slope and intercept.
d) Analysis item: alanine aminotransferase (ALT), aspartic transaminase (AST), etc.
5.2.2 Calibration parameters of colorimetric item
5.2.2.1 Set calibration parameters
Click " ", and the display is as shown below:
Fig. 5-2-15
Click colorimetric item to be set on "Item list" on the left of working area (the item color will change after the
selection), and set relevant parameters in calibration parameters on the right one by one:
(1) Calibration method: select a calibration method from the pull-down menu of reagent specifications, and the
methods includes: 1-point linearity, 2-point linearity, multi-point linearity, Logit-Log3P, Logit-Log4P, Logit-
Log5P, exponential function, spline, broken line.
(2) Calibration point: input the quantity of standard solution in the input box (the input range is 1-10).
(3) Span point: input corresponding span point in the input box (the input range is 2-10, and 0 means invalid span
calibration).
(4) Standard solution: input the concentration of standard solution, sample volume for analysis, sample volume for
dilution, and diluent volume in standard solution setting.
(5) Calibration check: when checking offset degree, discreteness, sensitivity and conducting blank horizontal check
during calibration check, please input appropriate check value. Above checks will not be conducted for newly added
items by default.
(6) Timeout calibration alarm: if the prompt for timeout calibration is needed, input timeout period of calibration
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with hour as unit at this position. If the Analyzer is still under the standby status when the set time of calibration is
reached, an alarming message will be given. If the timeout calibration alarm function is not needed, please input "0"
in the input box.
After parameters are confirmed to be correct, click " " to save the parameters.
5.2.2.2 Calibration method
(1) 1-point linearity method (K factor method)
Working curve is made through measuring the absorbance of standard solution 1 (reagent blank) and inputting K
factor, and the calibration curve is as shown below:
Fig. 5-2-16 1-point Linearity Calibration Curve (K Factor Method)

a) Input "Calibration parameter"
Calibration type: [1-point linearity]
Calibration point: [1] (quantity of standard solution)
Span point: [0]
b) Confirm K factor
Input K factor on "Calibration result" window.
c)Calculate parameters of working curve
B (S1ABS): the absorbance of standard solution 1 (reagent blank) or the change rate of absorbance per minute.
K: refers to input value.
C1: the concentration of standard solution 1 (reagent blank), it refers to the input value.
d)Concentration calculation
CX  K   AX  B  C1  IFA  IFB
CX here refers to the concentration of sample to be tested, AX is sample absorbance or absorbance change per
minute, and IFA and IFB are constants of the Analyzer representing the slope and intercept.
e) Applicable analysis method
1-point endpoint assay, 2-point rate assay, 2-point endpoint assay, rate-A assay.
(2)2-point linearity method
Linear working curve is made through measuring standard solution 1 (reagent blank) and standard solution 2, and
the calibration curve is as shown below:
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Absorbance
Fig. 5-2-17 2-point Linear Calibration Curve

Calibration type: [2-point linearity]
Calibration Point: [2] (quantity of standard solution)
Span point: [2-10]
b) Calculate parameters of working curve
B (S1ABS): measure absorbance of standard solution 1 (reagent blank) or the absorbance change per minute
K: refers to the ratio constant of linear working curve. It is worked out by the measured value and input value of
standard solution 1 (reagent blank) and standard solution 2
C1: input the concentration of standard solution 1 (reagent blank)
C2: input the concentration of standard solution 2
A2: the absorbance of standard solution 2 or the change rate of absorbance per minute of standard solution 2
C2  C1
K
A2  B
K:
CX  K   AX  B  C1  IFA  IFB
Cx here refers to the concentration of sample to be tested, Ax is sample absorbance or absorbance change per
d) Applicable analysis method
(3)Multi-point linearity method
Linear working curve is made by linear regression for measuring blank (or standard solution 1) and standard
solution (standard solution 2 and 10), and calibration curve is as shown below:
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Fig. 5-2-18 Multi-point Linearity Calibration Curve (Linearity)

Calibration type: [multi-point linearity]
Calibration Point: [3-10] (quantity of standard solution)
Span point: [2-10]
b) Calculate parameters of working curve
B (S1ABS): the absorbance of standard solution 1 (reagent blank) or the change rate of absorbance per minute
representing the intercept of linear regression equation.
K: the reciprocal of working curve of linear regression
B (S1ABS) and K can be calculated by the following formulas
X  Cr
BS1ABS  A 
Y
Y
K
X

n

X :  Cri  Cr  A i  A
i 1
 
n 2
Y :   C ri  C r 
i 1
A
i 1
i
A:
n
n
C ri
Cr : i 1
n
A1 and A2 are the two measured values of standard solution (1), n refers to the quantity of standard solution N x 2,
and Cri refers to the concentration of standard solution (i).
CX  K   AX  B  C1  IFA  IFB
CX here refers to the concentration of sample to be tested, AX is sample absorbance or absorbance change per
d) Applicable analysis method
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(4) Logit-Log3P (non-linearity method)

It is applicable to convergent working curve due to absorbance increasing with the concentration, and Logit-Log3P
(non-linearity method) calibration curve is as shown below:
Fig. 5-2-19 Logit-Log3P Calibration Curve (Non-linearity Method)

Calibration type: [Logit - Log3P]
Span point: [0] invalid span calibration
b)Calculate parameters of working curve
B: the absorbance or approximate value of absorbance change per minute when Cx approaches ∞
K: the difference between the absorbance or approximate value of absorbance change per minute of blank
(standard solution 1) and B
a: refers to the approximate constant which can be worked out automatically
S1ABS, K and a are respectively displayed on "Calibration result" window.
CX  C  C1   IFA  IFB
K
AX  B 
1  aC
1  K   A X  B  

C  a  
 A X  B 
CX here refers to the concentration of sample to be tested, C1 is the blank concentration, and AX is sample
absorbance or absorbance change per minute. When CX approaches ∞, AX is closer to B, and if K<0, AX≤B+B, or
K>0, AX≥B+K, C=C1. IFA and IFB are constants of the Analyzer representing the slope and intercept.
d) SD value calculation
 A  A  
SD 
2N  3
(N=3-10, j=1 or 2)
The (Aij-Ai′) here refers to the difference between the absorbance Ai′ and measured value Aij or A12 worked out
by fitting equation. Every standard solution is tested for twice, thus the maximum quantity measured of Aij is 12.
e) Applicable method
(5)Logit-Log4P (non-linearity method)
It is applicable to convergent working curve due to absorbance increasing with the concentration, and Logit-Log4P
(non-linearity method) calibration curve is as shown below:
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a)Input "Calibration parameter"
K: the difference between the absorbance or approximate value of absorbance change per minute of blank
(standard solution 1) and B
a, b: refer to approximate constants which can be worked out automatically
S1ABS, K, a and b are respectively displayed on "Calibration result" window.
CX  C  C1   IFA  IFB
K
AX  B 
1  aCb
C  b 

 
 X  

 
absorbance or absorbance change per minute. K is approximate constant. When CX approaches ∞, AX is closer to
B, and if K<0, AX≤B+K, or K>0, AX≥B+K, C1=0. IFA and IFB are constants of the Analyzer representing the
slope and intercept.
 A  A  
SD 
 2N  4
(N=4-10, j=1 or 2)
(6)Logit-Log5P (non-linearity method)
As it has the same features as Logit-Log4P and the method can calculate one more parameter, in some cases, the
result is more precious, and the calibration curve is as shown below:
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K, a, b, c: refer to approximate constants which can be worked out automatically
S1ABS, K, a, b and c are respectively displayed on "Calibration result" window.
 
a  b  ln C  c  C  ln  AX  B 0

 K   A  B 
X
Work out C by Newton approximation method:
CX  C  C1   IFA  IFB

K
AX  B 
1  exp  a  b  ln C  c  C
absorbance or absorbance change per minute. K is approximate constant. When CX approaches ∞, AX is close to
B.
If K<0, AX≤B, or K>0, AX≥B, C=0. IFA and IFB are constants of the Analyzer representing the slope and
intercept.
 A  A  
SD 
2N  5
(N=5-10, j=1 or 2)
(7)Exponential function method (non-linearity method)
Working curve appears the tendency of dispersion as the absorbance increases with the concentration, and the
calibration curve is as shown below:
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Fig. 5-2-22 Exponential Function Calibration Curve (Non-linearity)

Calibration type: [exponential function]
B: the absorbance or approximate value of absorbance change per minute of blank (standard solution 1).
K, a, b, c: refer to approximate constants which can be worked out automatically
S1ABS, K, a, b and c are respectively displayed on "Calibration result" window.

AX  B  K  exp a   ln C   b   ln C   c   ln C 
2 3

A B
a   ln C   b   ln C   c   ln C   ln X
2 3
0
 K 
 
Work out C by Newton approximation method

CX  C  C1   IFA  IFB
CX here refers to the concentration of sample to be tested, C1 and C2-CN are the concentration of blank and
standard solution, and AX is sample absorbance or absorbance change per minute.
if K>0, AX≤B, or K<0, AX≥B, C=0. IFA and IFB are constants of the Analyzer representing the slope and
intercept.
 A  A  
SD 
2N  5
(N=5-10, j=1 or 2)
by fitting equation, and every standard solution is tested for twice, thus the maximum quantity measured of Aij is
12.
(8)Spline functions method (non-linearity method)
By this means, measured values of each standard solution (point to point) are connected to form a complete curve.
At this time, as errors can be fitted in the curve, thus the curve fitting is superior to broken line, and the calibration
curve is as shown below:
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Fig. 5-2-23 Spline Function Method Calibration Curve (Non-linearity)

Calibration type: [spline function]
a (l), b(l), c (l), d(l): approximate constants, l=1-N
S1ABS is shown as a(l) on "Calibration result" (axis intercept of absorbance).
X  a(I)  b(I)  (CX-C(I)  c(I))  (C X-C(I) )  d(I)  (C -C(I))
2 3
A X
f  (CX -C(I))  a  (I)  b  (I)  (CX -C(I))  d  (I)  (CX -C(I))2  d(I)  (CX-C(I))3 -A X
Work out C by Newton approximation method

CX  (C  C1)  IFA  IFB
CX here refers to the concentration of sample to be tested, C1-CN are the concentration of blank and standard
solution, and AX and A2-AN are sample absorbance or absorbance change per minute of standard solution.
IFA and IFB are constants of the Analyzer representing the slope and intercept.
d)SD value calculation
 A  A  
SD 
2N  4
(N=5-10, j=1 or 2)
e)Applicable method
(9) Broken line method (non-linearity method)
Draw working curve through measuring standard solution (1) to (5) or (10). The working curve is drawn by
connecting absorbance value of standard solution at points with multiple lines, and the calibration curve is as shown
below:
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Fig. 5-2-24 Broken Line Method Calibration Curve (Non-linearity Method)

Calibration type: [broken line]
S1ABS is the mean of the two measured values of standard solution 1 (absorbance or the change rate of
absorbance per minute)
C2 -C1
K
A2 -B
B: the absorbance or the absorbance change per minute of standard solution (1)
A2: the absorbance or the change rate of absorbance of standard solution (2)
C1: the concentration of standard solution (1) (input value)
C2: the concentration of standard solution (2) (input value)
Calculate K2, K3, K4, and K5 as the same way as standard solution (1)- standard solution (10).
CX  K N   AX  AN   CN   IFA  IFB
d)Applicable method
5.2.2.3 Calibration type
There are four different calibration methods based on various quantity of standard solution. Only conduct blank
calibration for standard solution 1 (reagent blank), and only conduct span calibration for one standard solution
(except for reagent blank solution). Conduct two-point calibration for reagent blank solution and one standard
solution, and use all set standard solution for full-point calibration. Make choice based on different demands.
Set calibration method on "Calibration parameter" window.
(1)Blank calibration
Only calibrate standard solution 1 (reagent blank). Calculation methods for various calibration types are listed in
Table 5-2-1.
a) Calculate absorbance of reagent blank (S1ABS)
Table 5-2-1 S1ABS Calibration
Calibration type Calculate absorbance of reagent blank (S1ABS)
1-point linearity (A11+ A12)/2
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Calibration type Calculate absorbance of reagent blank (S1ABS)
2-point linearity (A11+ A12)/2
Multi-point linearity {(AU+ A12)/2-(AU′+ A12′)/2}+S1ABS′
Logit-Log3P {(A11+ A12)/2-(A11′+ A12′)/2}+S1ABS′
Logit-Log4P {(A11+ A12)/2-(A11′+ A12′)/2}+S1ABS′
Logit-Log5P (A11+ A12)/2
Exponential function (A11+ A12)/2
Spline function {(A11+ A12)/2- S1ABS′}+a(I)
Broken line (A11+ A12)/2
A11: the first absorbance of standard solution (1) measured this time
A12: the second absorbance of standard solution (1) measured this time
A11': the first absorbance of standard solution (1) measured of the previous test
A12': the second absorbance of standard solution (1) measured of the previous test
S1ABS': the previous S1ABS value
a(l): l=1-N, N is the quantity of standard solution to show the coefficient of curve (please refer to Logit-Log5P)
When input "1" as the quantity of standard solution (K factor method), only calibrate reagent blank.
b) Applicable calibration method
1- point linearity, 2-point linearity, multi-point linearity, Logit-Log3P, Logit-Log4P, Logit-Log5P, exponential
function, spline function, broken line.
(2) Span calibration
It is a method of 1-point standard solution except for the calibration of reagent blank solution to measure
corresponding standard solution at the span point set on "Calibration parameter" window, and see Table 5-2-2 for
calculation method:
a) Calculate K factor and S1ABS
Table 5-2-2 Calculate S1ABS and K Value
Calibration type Calculate K factor S1ABS
2-point linearity (C2-C1)/(A2-S1ABS) Previous value
Multi-point linearity (CN-C1)/(AN-S1ABS) Previous value
C2: the concentration of standard solution (2)

CN: the concentration of standard solution (N) (N refers to span point)
A2: the mean of measured absorbance of standard solution (2)
AN: the mean of measured absorbance of standard solution (N)
b)Applicable calibration method
2- point linearity, multi-point linearity.
(3)2-point calibration
It is a calibration method for calibrating reagent blank solution and another standard solution. Measure
corresponding standard solution at the span point input on "Calibration parameter" window, and see Table 5-2-3 for
calculation method:
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a) Calculate K factor and S1ABS

Table 5-2-3 Calculate S1ABS and K Value
Calibration type Calculate S1ABS Calculate K value
2-point linearity (A11+ A12)/2 (C2-C1)/(A2-S1ABS)
Multi-point linearity (AU+ A12)/2 (CN-C1)/(AN-S1ABS)
A11, A12: the first and second absorbance of standard solution (1) measured this time
CN: the concentration of standard solution (N) (N refers to span point)
A2: the mean of measured absorbance of standard solution (2)
AN: the mean of measured absorbance of standard solution (N)
b) Applicable calibration method
2-point linearity, multi-point linearity.
(4) Multi-point calibration
Calibrate all standard solution set on "Calibration parameter" window (including reagent blank solution), and the
calibration result will be renewed after calibration.
a) Calculation formula
It varies based on different calibration methods.
b)Applicable calibration method
Multi-point linearity, Logit-Log3P, Logit-Log4P, Logit-Log5P, exponential function, spline, broken line.
5.2.2.4 Check during calibration
During calibration analysis, calibrated items can be checked by various methods, such as blank horizontal check,
discreteness check, sensitivity check, K factor check and offset degree check.
(1) Blank horizontal check
During calibration, when the average absorbance of standard solution 1 (reagent blank)measured for twice exceeds
the stipulated range of blank level check, an alarm (attention level) of exceeding reagent blank level check will be
given, and meanwhile calibration result will fail to be displayed on the list.
If an alarm is given for an analysis item, its calibration reaction curve will renewed but K value will not. If the check
is not to be executed, please input "-3.3 - 3.3".
(2) Check discreteness
During calibration, measure each standard solution (including reagent blank, i.e. standard solution 1) twice and use
its mean. If the difference of absorbance measured twice is larger than the stipulated value of discreteness check, an
alarm of exceeding discreteness check value (attention level) will be given, and meanwhile, the calibration result
will fail to be displayed on the list.
is not to be executed, please input "3.3".
Conduct discreteness check with the usage of following formulas:
|A standard solution (N) the first time - A standard solution (N) the second time|≤ the absorbance of discreteness check (ABS)
(3) Sensitivity check
During calibration, if the difference between the absorbance of standard solution 1 (the mean of absorbance
measured twice) and the absorbance of standard solution with maximum concentration (the mean of absorbance
measured twice under non-linearity and multi-point linearity conditions) is larger than the stipulated value of
sensitivity check, an alarm of exceeding sensitivity check value will be given, and meanwhile calibration result will
fail to be displayed on the list.
is not to be executed, please input "0".
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Check sensitivity with the usage of following formulas:

sensitivity check value (ABS)
(4) K factor check
If the difference between previous K factor and the current one after calibration exceeds 20% of the mean between
the previous value and current value (the fixed value), an attention-level alarm of abnormal K factor check will be
given, and working curve and K factor will be renewed but calibration status will not. Therefore, test at that day can
be executed, but users are recommended to test samples after figuring out the reason of the alarm.
Check K factor with the usage of following formulas:
Kthis  Klast
100%  20%
(Klast  Kthis )
2
(5) Offset degree check
In the case of non-linearity working curve and multi-point linearity working curve, the difference between the
absorbance of all concentrations and measured absorbance is worked out through approximate formula, and if the
stipulated value of offset degree check is exceeded, an alarm of exceeding offset degree check (attention level) will
be given, and meanwhile, calibration result will fail to be displayed on the list. The working curve and K factor will
be renewed but calibration status will not. Therefore, test at that day can be executed, but users are recommended to
test samples after figuring out the reason of the alarm.
If the check is not to be executed, please input "3.3".
5.2.3 Range parameters of colorimetric item
Click " " to enter options and to set specific reference value, default value, linear range and
emergency value. After setting, click " " to save parameters. The interface is as shown below:
Fig. 5-2-25 Range parameter

(1) Specific reference value: if the patient's age and sex are different and reference range varies, specific reference
range shall be used.
a) Click " ", and the "reference range setting" window will pop up as shown below:
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Fig. 5-2-26
Age, month, day and hour are available for selection as age unit. Input the relevant setting value in the input box,
click " " to finish the setting of the reference range, then click " " to exit the
window of reference range setting.
If this item is selected, operator needs to set the age and sex of patients before the Analyzer works out the
result, otherwise the test result will be displayed as the default reference range.
b) Select the specific reference value range from the list, and click " " to modify the added content
related to the specific reference value.
c) Select the specific reference value range from the list, and click " " to delete the added specific
reference value.
(2) Default reference value: the "Default reference value" range is used when the reference range is the same for the
patient of different ages and sexes.
For instance: the default reference value range of urine amylase is 0U/L - 640U/L. The interface is as shown below:
Fig. 5-2-27
(3) Linear range: please refer to the reagent specifications to input the upper and lower limits of reagent linear range.
If the test result exceeds the range, an alarm will be given.
(4) Emergency value range: please refer to clinic condition and using condition to input the range, upper and lower
limit of emergency value. When the test result exceeds the range, an alarm will be given, and meanwhile "E" will be
displayed in detection result prompt box.
5.2.4 Manual item parameters
Select item to be set from the "Manual item" list of "Item list" to set item parameters, and then click "
" as shown below:
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Fig. 5-2-28
(1)Item unit: select the item unit of manual item from the pull-down menu.
(2)Reference range: input the parameter range of manual item in the input box.
5.2.5 Parameters of ionic item
Select item to be set from "Ion item" list of "Item list" to set item parameters, and then click " " as
shown below:
Fig. 5-2-29
(1)Item abbreviation: select the item abbreviation from the pull-down menu.
(2)Item unit: select the item unit from the pull-down menu.
(3) Decimal place: Select the number of decimal places from the pull-down menu.
(4) Factor (Y=aX+b): input the value of a and b in the input box. See "5.2.1.1 (8)" for details.
(5)Sample type: select the sample type from the pull-down menu.
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(6) Specific reference value: if the patient's age and sex are different and reference range varies, specific reference
range shall be used. See "5.2.3 (1)" for details.
If this item is selected, operator needs to set the age and sex of patients before the Analyzer works out the
result, otherwise the test result will be displayed as the default reference range.
(7) Default reference value: the "default reference value" range is used when the reference range is the same for the
patient of different ages and sexes.
(8) Emergency value range: please refer to the clinic condition and using condition to input the range, upper and
lower limit of emergency value. When the test result exceeds the range, an alarm will be given, and meanwhile "E"
will be displayed in detection result prompt box.
(9) ISE reagent volume setting: input reagent volume in the input box, and set corresponding reagent volume alarm
of reference solution, diluent and internal standard solution, and then click " " to save the parameter.
In introduction about the application software of the Analyzer in the user manual, most parameters taken as
example are of no actual test meaning. Please refer to relevant specifications for reagent parameters.
5.3 Serum information
Click " " on the "System Setting" window to enter the window of serum information setting, and the display
is as shown below:
Fig. 5-3-1
Serum information refers to figure out the function of serum information index through measuring the content of
lipoidemia (L), hemolysis (H), icterus (I) in serum.
L: abbreviation of lipemia.
H: abbreviation of hemolysis.
I: abbreviation of icterus.
Compensation calculation can be made for the analysis result by the using of serum information, or qualitative result
can be obtained by measured value. Different analysis methods may result in the increase of hemolysis, lipemia and
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bilirubin, or may affect the measured result die to the function of dose and its metabolite.
The detection of serum information can show the content of lipemia, hemolysis and icterus in serum. The reagent
used is colorless and clear, such as ALT, AST and LDH item, and the non-analysis time belt of rate-A is adopted for
analysis (light measuring point 5 ≤L<m≤31), thus serum information and item will be measured respectively.
(1) Measured wavelength of serum information
Lipemia: the main wave should be measured at 660nm, and the sub-wave at 700nm to be free from the effect of
hemolysis and icterus.
Hemolysis: the main wave should be measured at 570nm, and the sub-wave at 600nm to be free from the effect of
lipemia and icterus.
Icterus: the main wave should be measured at 480nm, and the sub-wave at 505nm to be free from the effect of
lipemia and hemolysis.
(2) Measured value and light measuring point
Measure serum exponential to use each measured absorbance value to minus reagent blank absorbance value.
4 λMain / λsub = 480nm / 505nm)
Icterus: ΔE I = ΔE 4 - ΔE B（
Hemolysis: ΔE H = ΔE 4 - ΔE B（
4 λ Main / λ sub = 570nm / 600nm)
Lipemia: ΔEL = ΔE4 - ΔEB4 (λMain / λsub = 660nm / 700nm)

Including:
ΔE represents the absorbance value of the main wave of icterus, hemolysis and lipemia at the light measuring
point 4 subtracted by sub-wave.
ΔEB4 represents to the reagent blank value measured at the light measuring point 4.
(3)Calculation formula of L, H and I exponential and A-F coefficient setting
1
L  E
L
C
1
H  (E -B E )
H L
A
1
I  (E -E  E -F E )
I H L
D
Including:
L, H and I refer respectively to the exponential of lipemia, hemolysis and icterus.
C,A and D are coefficients that turn the absorbance into serum information.
B, E and F are coefficients for calibration of lipemia, hemolysis and icterus gained from absorption spectrum.
Set A-F coefficients as following data by default in serum information setting, and user can modify them manually
based on actual clinic demands.
Input as 5th power of 10 times of B, E and F.
B=121000
E=15000
F=170000
Input as 10 times of C, A and D. C=320
A=1271
D=4350
The Analyzer regards C, A and D value as coefficients when guessed sample volume is 10μL and R1 reagent volume
is 200μL.When sample volume and R1 reagent volume need to be changed, C, A and D value need to be modified
to be C', A' and D':
C  C K
A  A K
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D  D K
Input "Coefficient A-F" in the system following the methods above. As tested items and coefficients are common
for L, H and I, input any one of them is valid for other serum information.
If to execute qualitative determination, select "Qualitative determination" and then input determination standard.
Determination is divided into 6 grades, and the range of result value input on the left must be increasing gradient.
Input "+", "-" on the right.
After inputting, click "Save" to save the parameters.
5.4 Item combination
Click " " on the "System Setting" window to set combination, and the display is as shown below:
Fig. 5-4-1
(1) Number: input the combination number in the input box within the range of 0-99, and the number cannot be
repeated, otherwise, it cannot be saved.
(2) Combination name: input the name of the combination to be set in the input box, and the name can be letters,
numbers, Chinese characters, but it cannot be repeated, otherwise it cannot be saved.
(3) Item list: select items included in the combination from "Item list", and click " "at the front end of item name to
select; then again click the check box, and " " represents not selected.
Manual item added can be displayed in the item list.
(4) Click " ", and combination number and name will be displayed on the "Item Combination
List" on the right. Click combination number or name in the working area, and all items included will be displayed
on "Item of the combination list".
(5) Click combination number or name on "Item Combination List", and again select items included in the
combination on "Item Combination List", then click " " to save modified items.
(6) If to delete an item combination, select the combination number or name to be deleted and click "
".
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5.5 Calculation and compensation item

Calculation and compensation item is to edit another new item of clinic meaning through specific calculation by
using the test result of two or more items, such as A/G, AST/ALT.
Click " " to enter the setting window of calculation and compensation item and the display is as shown
below:
Fig. 5-5-1
5.5.1 Calculation item
Click " " on the "Calculation & Compensation" window as shown in Fig. 5-5-1:
(1)Item Abbreviation: input the item abbreviation of calculation item in the input box.
(2) Item Full Name: input the full name of calculation item in the input box.
(3) Unit: Select the unit of new calculation item from the pull-down menu, if the item has no unit, selection will not
be made.
(4) Decimal Place: select the number of decimal places of the calculation item from the pull-down menu.
(5) Reference range: input the upper and lower limit of reference range of the calculation item in the input box.
(6) Calculation formula: select item name involved in calculation from the "Select item" pull-down menu, and select
numbers, symbol in numeric character area, then the formula edited will be displayed the in "Calculation Formula"
input box.
After editing, click " ", and all information of the calculation formula will be displayed on the
list in the working area,then the setting of calculation formula is successfully finished. Click " " and
all content in the "Calculation Formula" input box will be empty.
If to modify the content of calculation formula, click item to be modified in the working area, and reset in the
"Calculation Formula" input box then click " " to save.
If to delete calculation item, click item to be deleted in the working area, and then click " ".
Editing method of calculation formula (take A/G as example):
Set Item abbreviation, full name, unit, decimals and reference range of items following steps above. Select [ALB]
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from the "Select Item" pull-down menu, and click symbol [/], then select [TP] from the "Select Item" pull-down
menu and click symbol [-], next, select [ALB] from the "Select Item" pull-down menu. Every editing of the formula
will be displayed in the "Calculation Formula" input box as shown in " ".
If numbers exist in the formula, click 0, 1, 2, 3, 4, 5, 6, 7, 8, and 9. After inputting, click " " and
the calculation formula will be displayed in the working area as shown in Fig. 5-5-2:
Fig. 5-5-2 Calculation Formula
If input a wrong content, click " " on the right of "Calculation Formula" to empty all the content in the
input box.
5.5.2 Compensation item
Click tab "Compensation Item" on the "Calculation & Compensation" window and the display is as shown below:
Fig. 5-5-3
Relevant content and editing method of compensation item are the same as that of calculation item, and see "5.5.1
Calculation item" for details.
5.6 Cross contamination

To avoid cross contamination is a function used to reduce or avoid cross contamination among analysis items.
As cross contamination between items varies due to reagent formulas, users are required to separate items with cross
contamination by those without cross contamination when presetting to eliminate cross contamination between
items. If all items cannot be separated, contaminated items can be avoided by setting cross contamination to reduce
the cross contamination between items to the greatest extent.
The application of cross contamination may lower the test speed of the Analyzer.
Cross contamination includes the cross contamination between probes, and between cuvettes.
Click " " on the "System Setting" window to enter "Cross contamination" setting window.
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5.6.1 Cross contamination of probe

Set to avoid cross contamination of probe on the "Probe" window and the display is as shown below:
Fig. 5-6-1
(1) Add single item:
a) From reagent: select the item causing cross contamination from "Item abbreviation" pull-down menu, and
select the reagent type from "Type" pull-down menu.
b) To reagent: select the item affected by cross contamination from "Item abbreviation" pull-down menu, and
select the reagent type from "Type" pull-down menu.
Detergent position is not fixed, which needs registering on the reagent disk. If detergent is used up, water is
used for cleaning.
c) After editing, click " " and information set will be displayed in the working area. Setting to
avoid cross contamination of reagent is successful.
(2) Batch dispensing
Click " "to enter the "Batch Addition" interface, and "From reagent" is displayed on the left,
while "To reagent" is on the right, and the display is as shown below:
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Fig. 5-6-2
a) Select the type of "from reagent" from the pull-down menu, and click to select the reagent item abbreviation;
b) Select the type of "to reagent" from the pull-down menu, and click to select the reagent item abbreviation;
c) Input the detergent volume in the input box;
d) Click " " to finish batch adding of cross contamination of probe.
(3)If to delete set information, select set information and click " ".
Item set for cross contamination of probe must be the one registered in reagent information.
5.6.2 Cuvette cross contamination
Click to set "Cuvette" on the "Cross-contamination" window to avoid cuvette cross contamination as shown below:
Fig. 5-6-3
(1)From Item: from the pull-down menu select a name.
(2)To Item: from the pull-down menu select a name.
(3)Input the detergent volume in the input box.
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Detergent position is fixed at position 45 of reagent disk 1 or reagent disk 2.
After editing, click " " and information set will be displayed in the working area. Setting to
avoid cross contamination of reagent probe is successful.
If to delete set information, select set information and click " ".
5.7 Report format
Click " " on the "System Setting" window to set relevant print information and the display is as shown
below:
Fig. 5-7-1
(1) Current print format: select a print format on "Current print format" and click " " to finish the
setting.
(2) The first name of unit: input the unit name in the input box.
(3)The second name of unit: input the unit name in the input box.
(4)Report title: input the report title in the input box.
(5) Print report endnote: if to use report endnote, click to select " " and respectively input
relevant information in the input box of "Report endnote 1" and "Report endnote 2". If not to use,
" " cannot be selected.
(6) List of printing options: if to add content to be printed in printing sequence list, click to select the option box, and
" " represents selected while " " represents not selected. The optional contents include: prompt, item
abbreviation, test result, item full name, unit and reference value.
(7) Auto print: click to confirm whether "Auto Print" is selected based on actual demands, only by selecting "Auto
Print" (" " means selected and " " means not selected) can "Print only a sample of patient information" can be
selected.
(8) Result positive mark: select the positive mark of the print result, which can be set as "arrow (↑; ↓)" or "high/ low
value (H; L)" from the pull-down menu.
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After setting, click " " to save the basic information of the report.
5.8 Other information
Click " " on the "System Setting" window to set functions such as sample test mode, reagent alarm setting,
database automatic backup setting, ISE setting, alarm setting of rinsing sample probe, ISE reagent alarm setting,
QC accumulation, auto sleep setting, timed wake-up setting, and the display is as shown below:
Fig. 5-8-1
(1) Sample test mode: for "Sample registration", and two registration methods are available.
a) Order sample number: place the samples to be tested on a sample reagent disk based on the sequence of
sample number registered.
b) Sample barcode number: when the function is selected, the Analyzer will register the sample barcode number
scanned.
Sample test mode cannot be changed when there is untested sample in set modes in sample registration.
(2) Reagent alarm setting: from the bottle specification pull-down menu, select 20mL, 35mL or 70mL. Input the
alarm volume in the alarm volume input box, unit mL. When the Analyzer detects that the reagent volume is less
than the set value, an alarm will occur.
(3) Database automatic backup setting
Click to select " ", and input the interval days of automatic backup in the
"interval time" input box, and then the software will back up the database automatically according to the setting;
when the database is damaged, it can be restored to the one backed up previously. Then input range of interval days
is 1~180.
(4) ISE setting: when ISE module is used, if any setting or test about ISE is needed, select the item, " " means selected
and " " means not-selected.
The function can only be selected under ISE standby status; the item will be displayed in gray when ISE is
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not online.
(5) ISE reagent alarm setting: input alarming reagent left in the input box of reference solution, diluent and internal
standard solution, and an alarm will be given in alarm information when ISE reagent left detected by the Analyzer
is less than the stipulated value.
(6) Alarm setting of rinsing sample probe: input numbers in "Numbers of test items", and an alarm will be given in
alarm information when the number is reached.
(7) QC accumulation: Click " ", and the last test result that day of all QC items
will automatically accumulate to monthly QC.
(8) Reagent position setting: click " " to set reagent position and sample position in sample reagent
disk, and the display is as shown below:
Fig. 5-8-2
(9) Auto sleep setting: input in or select from the "Sleep time" box, and the analyzer will automatically enter sleep
mode when arriving at the set time.
(10) Timed wake-up setting: input in or select from the "Wake-up time" box, and the sleeping analyzer will wake up
at the set time. You can also click the "Wake-up" key to manually cancel the timed wake-up setting.
Click " " to save the set information. Click " " to exit the window.
5.9 LIS communication
This setting must be done under offline status.

If the Analyzer and other LIS systems are online, it is required to realize LIS communication setting on the window
of system setting. The communication mode applies standard TCP/ IP network interface communication and
conforms to the HLT 2.3.1 protocol standard, and the display will be as shown below:
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Fig. 5-9-1
(1) Enable LIS: select the item to enable LIS communication function; otherwise, disable the LIS communication
function.
When the LIS communication status of the Analyzer is to be changed, the software of the Analyzer must be
logged in again.
(2) Bidirectional communication: select to realize two-way communication with LIS.
(3) Basic modes: Divided into two types: one is serial port mode, in which the Analyzer and LIS host are connected
through RS-232 serial port, and the other is network mode, in which the Analyzer achieves LIS communication
through IP address.
(4) Result transmission mode: there are two modes, one is real-time mode, namely, when all the items of each sample
are tested, the sample is regarded as the unit for real-time transmission, the other is manual mode, namely, results
can only be transmitted manually after test.
When the basic mode of "LIS communication of the Analyzer" is set to "network mode", relevant parameters will
be set as shown below:
(5) Instrument ID: identification used to describe the analyzer under communication during LIS transmission.
(6)LIS Host ID: Identification of the LIS system under communications with the Analyzer.
(7)LIS Host IP: input the IP address of the Analyzer, and user can set it according to the actual situation.
(8)Host port: host port number.
(9)Timeout retry time: the time interval for communication timeout retry can be set.
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Chapter 6 Calibration Information
Click " " in the functions area to register calibration information and check calibration result.
The interface is as shown below:
Figure 6-1
6.1 Colorimetric calibration
6.1.1 Register colorimetric item calibration
Click " " on the "Calibration Info" window and the display is as shown below:
Fig. 6-1-1
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(1) If to register colorimetric item calibration, firstly select a proper calibration type which can be divided into four
kinds, including blank calibration, span calibration, two-point calibration, and full-point calibration, see Table 6-1-
1:
Table 6-1-1
Calibration Quantity of standard

Calibration result Calibration method Application examples
type solution
When testing by K factor
Blank Only renew blank All calibration
Only blank solution method and the omissions
calibration value of reagent methods
of standard solution
Range One point other than Only renew K 2-point linearity, Recheck standard solution
calibration blank solution value multi-point linearity 1 point
Make standard curve by
Renew reagent 2-point linearity
Two-point Blank solution and span 2-point linearity,
blank value and Use multi-point method
calibration point multi-point linearity
K value while omit the quantity of
standard solution
Renew standard
Full-point All standard solution Multi-point linearity, Multi-point standard
curve by all
calibration registered non-linearity curve
points
Click calibration type button, for example, click "2-point calibration" to conduct the two-point calibration of UREA
item, and the display will be as shown in Fig. 6-1-2:
Fig. 6-1-2
Click to select "UREA" (its color will change after the selection), and after inputting the calibration name and
calibration lot number click " ", then items registered will be displayed in the working area of
calibration registration, and click " " to close the selection window of calibration registration.
(2) Click to select the registration information and then click " " to delete single calibration item,
and click " " to delete all items of calibration registration.
(3) After the registration of calibration items, set the concentration value in the input box based on parameters of
standard solution, and select the position to place standard solution from the pull-down menu (the input range is
0~40, and 0 refers to not set), and then click " " to finish the setting.
6.1.2 Calibration result of colorimetric item
(1) Calibration result
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Click " " on the "Calibration Info" window to confirm calibration results like constant A, B and C
approximate to functions such as reagent blank (i.e. S1ABS), K factor and multi-point calibration curve, and the
display is as shown below:
Fig. 6-1-3
If to modify calibration result under the standby status, move cursor to the input box to be modified, and input
calibration result modified, then click "Enter" on the keyboard to confirm to save.
Screen from the pull-down menu following "Item Name" to view the calibration result of a certain item, and the
display is as shown below:
Fig. 6-1-4
If the calibration fails, check whether the input parameters, calibrator used and reagents are correct, or operate
according to the alarm message and relevant prompts.
(2) Calibration tracing
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The Analyzer will automatically save the absorbance value of standard solution of each calibration. Whether the
absorbance change is stable can be confirmed through tracing diagram on calibration tracing window to confirm the
accuracy of calibration.
Click " " on the interface of Calibration Result in Fig. 6-1-4, and the display is as shown below:
Fig. 6-1-5
Select the item name and standard solution from the pull-down menu, then the absorbance value of recent 50 times
will be displayed on the diagram. Meanwhile, the calibration method and time of the item will be displayed on the
window.
Click " " to set the absorbance range displayed.
Click " " to print the calibration tracing curve diagram.
Click " " to display the reaction curve of the calibration item, the x-axis is calibration times and
the y-axis is the absorbance of standard solution.
Click " " to close the window.

(3)Calibration curve
Click " " on the interface of Calibration Result in Fig. 6-1-4, and the display will be as shown
below:
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Fig. 6-1-6
Select the item name and standard solution to be viewed from the pull-down menu of "Test Item" and "Std.". S1Abs
value, K value, A value, B value and C value of the item, absorbance, test and calibration method that time, current
setting calibration method and calibration time will be displayed on the window.
a) Click " " to set the absorbance range displayed.
b) Click " " to print the calibration curve diagram.
c) Click " " to display the reaction curve of the calibration item, the x-axis is the concentration of
standard solution and the y-axis is the absorbance of standard solution.
d) Select standard solution to be viewed (standard solution 1-10) from "Standard solution" pull-down menu to
view every absorbance value of standard solution which will be displayed on the calibration curve window.
e) When the non-linearity calibration method is set as current calibration method, absorbance and calibration
method are editable. After the item calibration by non-linearity calibration method is successful, select calibration
method from "Cal. method current" pull-down menu on the interface of calibration curve, and modify the
absorbance value on the right, then click "Fit Again" to form new calibration curve on the interface; if proceed to
click "Save", the current absorbance value, calibration method and calibration curve will be saved, and
"Calibration method" in "Item parameter" will be renewed to the modified one.
"Cal. method current" can only be modified from the method of more calibration points to that of fewer
points rather than reversely.

(4)Reaction process
The absorbance change at all time points of items can be viewed on the "Reaction Process" window, and can be
confirmed on the reaction curve diagram to see whether the reaction status and the measured value of absorbance
are stable.
Click " " on the interface of Calibration Result in Fig. 6-1-4, and the display is as shown below:
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Fig. 6-1-7
Select the item abbreviation from "Test Item" pull-down menu; select the number of standard solution from
"Standard Solution" pull-down menu; select the test times of standard solution from "Calibration Times" pull-down
menu (each standard solution is test for twice); select "Main - Sub", "Main wavelength" or "Sub-wavelength", and
the reaction curve diagram of the item's standard solution will be shown with its x-axis is light measuring point and
y-axis is absorbance.
a) Main-Sub: display the reaction curve of the absorbance difference between main wavelength and sub-
wavelength.
b) Main wavelength: display the reaction curve of main wavelength absorbance.
c)Sub-wavelength: display the reaction curve of sub-wavelength absorbance.
If to carefully view the absorbance value of a certain light measuring point, select the point to be viewed from the
"Point" pull-down menu, and the value of the point will be displayed following "Absorbance:".
Click " " to set the absorbance range displayed.
Click " " to print the reaction curve.
Click " " to display the reaction process curve of the calibration item, the x-axis is light measuring
point and the y-axis is the absorbance of standard solution.
After a new item is added, the item should be calibrated first and inaccurate calibration result may have
impact on the test result.
(5) Print result
Click " " on the interface of Calibration Result in Fig. 6-1-4 to preview the calibration result of
colorimetric item. If to print the calibration result, click the print button at the top of preview screen.
(6) History calibration results
On Figure 6-1-4 (the calibration results interface) click the " " button, and the interface is as
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shown below:
Fig. 6-1-8
Select the abbreviation of the item from the "Item Name" pull-down menu, and then the historical calibration
results corresponding to the item will be displayed on the list.
User Manual
Chapter 7 QC Management
Laboratory QC is designed to ensure the reliability of the measured result for each sample. The reliability of
measured results covers two aspects: one is the precision, i.e. repeatability of measured results and little change in
the results measured daily in laboratory (QC is mainly used to eliminate or reduce the impact caused by random
error); the other is accuracy, i.e. correctness of measured results and their approach to the true value (QC is mainly
used to eliminate or reduce the impact caused by system error).
Random error: the difference between the measured result and the mean of measured results obtained by infinitely
many measurements of the same measured item under repetitive conditions is called random error.
System error: under repetitive conditions, the difference between the mean of measured results obtained by infinitely
many measurements of the same measured item and the true value of measured item is called system error. It is an
error component of measured results expected not to be zero.
Accuracy: it is a combination of system error and random error of the measured results, indicating the consistent
degree between the measured results and true values.
Precision: it indicates the size random error of measured results. Precision refers to the degree of compliance
between the measured results when multiple measurements are made under certain conditions.
L-J (Levey Jennings) QC chart: QC chart is a chart with QC limits. QC limit is determined by the mean ( X ) and
standard deviation (SD) obtained by repeated measurements of the known specimen (usually QC solution) by the
controlled analysis method. X  2SD is the alarm limit while X  3SD is out-of-control limit.
Click " " in the functions area and the display is as shown in Fig. 7-1:
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Fig.7-1
7.1 QC registration
Click " " in the working area, and the QC registration window will pop up as shown below:
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Fig. 7-1-1
Add or delete QC item or set QC position and QC rules on the QC registration window. At most 8 QC solutions can
be used at the same time for QC.
7.1.1 Set QC rules
Click " " on "QC registration" and Westgard QC rules will be as shown below:
Fig. 7-1-2
Operator can click to select proper QC rule based on test demands, then click " " to save QC rules.
Click " " to return to the QC registration window and conduct out-of-control analysis of QC data
following the set rules on "Monthly QC" window.
Conduct out-of-control analysis for the measured QC results according to the multi-rule judgment benchmark of
Westgard. The figure below is the multi-rule logic diagram of Westgard:
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Fig. 7-1-3 Multi-rule Logic Diagram of Westgard

Description of judgment benchmark:
12S: if a QC result is beyond the mean ±2SD, it is only applicable to be alarm rule and other rules are enabled to
inspect QC data.
13S: if a QC result is beyond the mean±3SD, it is determined to be out-of-control and this rule is mainly sensitive to
random error.
22S: if two continuous QC results are simultaneously beyond the mean +2SD/ -2SD, it is decided as out of control
and this rule is sensitive to system error.
R4S: if a QC result exceeds the mean +2SD and the other QC result is below the mean -2SD, it is determined to be
out-of-control and this rule is sensitive to random error.
41S: if four continuous QC results are simultaneously beyond the mean +1SD/ -1SD, it is determined to be out-of-
control and this rule is sensitive to system error.
10
X
: if 10 continuous QC results fall at one side of the mean (above or below the mean without requirements for
deviation size), it is decided as out of control and this rule is sensitive to system error.
7.1.2 Add QC parameter
Set the information of QC items on the right of the "QC Registration" window:
(1) Input the name of QC solution in the "QC Name" input box.
(2) From the "QC Level" pull-down menu select high value or low value.
(3) From the "QC Effective Date" pull-down menu select the expiry date of the control liquid.
(4) Input the lot number of QC solution in the "QC Lot No." input box.
(5) Select QC test items from the "QC Item" pull-down menu.
(6)Select sample type from the "Sample type" pull-down menu.
(7) Input the target value and SD of QC item in the input box of "Target Value" and "Std. Deviation ".
(8)Click the box in front of dilution to select whether to dilute QC solution (" " means selected, and " " means
not selected).
After the selection of "Dilution", sample volume and diluent volume for dilution must be correctly set in
analysis parameters to execute QC test.
Click " " to save the parameters, and QC parameters will be displayed in the working area on
the left.
After the QC item is registered and before a certain QC item is tested, items to be applied with QC test shall
be confirmed, i.e. selecting " " on "Execute" list, such as:
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7.1.3 Modify QC parameter

If to modify lot number, type, item, target value, SD, click item to be modified in the working area on the left, and
then the color of the item will change. Display the QC target value and SD of the item in the working area on the left.
Input modified parameters of the item to be modified and click " " to save.
7.1.4 Delete QC item
Select item to be deleted in the working area on the left, and the color of the information will change after clicking.
Click " " to delete all information of the item.
7.1.5 Set QC position
Click " " on the "QC registration" window, and the editing window of QC position will pop up
as shown below:
Fig: 7-1-4
Click the QC information to register the position, then the color of the information will change. Select the QC
position number from "Disk No.", "Position" pull-down menu on the right of the window, and click "
" to successfully register QC position, then click " " to exit the window.
Same item of different QC name should not be applied to one test at the same QC position.
7.1.6 QC test
After QC registration, confirm whether reagent is placed correctly. Execute reagent horizontal scan, place QC
product at the corresponding position of the sample reagent disk, then click "Send test" and select " "
on "Start Test" window, and the display is as shown below:
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Fig. 7-1-5
Click " " to start QC test.

If QC is out of control, check whether the input parameters, QC products used and reagents are correct, or operate
according to the alarm message and relevant prompts.
7.2 Daily QC data

After QC test, the Analyzer automatically calculates the measured QC target value (mean), standard deviation,
variation coefficient and other data.
N
X
i 1
i
(X) :
Target value: N
(X  MV)
Standard deviation (SD): N1
SD
100%
Variation coefficient (CV%): mv
Deviation: Xi- (mean)
Deviation
100%
% error: mv
Including:
N is the test number
Xi is test result
Click " " on the "QC Management" window and the display is as shown below:
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Fig. 7-2-1
Intraday QC result will be displayed on QC list.
(1) Click " " to print the intraday QC test.
(2) Click " " to view the reaction process of QC test.
(3) Click " " to switch between "QC data" window and "QC diagram" window.
In case of "QC Diagram" status, click " " to print intraday QC report.
(4)Monthly QC accumulation:
a) Manual accumulation: Click " " and the display is as shown below:
Fig. 7-2-2
After selecting QC information, click " " to accumulate QC information into monthly QC
statistics. After the accumulation of QC information, select whether to delete the daily QC result.
b) Automatic accumulation: if to automatically accumulate monthly QC result of all QC item, select
" " on "Other information" window of "System Setting". The last result of daily
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QC test will automatically accumulate into monthly QC.

If neither of the 2 accumulation methods is selected, the intraday QC result will not be accumulated into monthly
QC.
(5)Click " " to send QC result displayed on the list to LIS system.
(6)Click " " and the display is as shown below:
Fig. 7-2-3
Select the QC date, QC name and QC lot number from the pull-down menu, and all qualified QC data information
will be displayed on the list on the right.
7.3 Monthly QC
Click " " on the "QC Management" window and the display is as shown below:
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Fig. 7-3-1
Monthly QC information and result will be displayed on the QC list.
(1)Click " " to print the monthly QC test.

(2)Click " " to switch between "QC data" window and "QC diagram" window. The interface is
as shown below:
Fig. 7-3-2
Select from the pull-down menu of "QC month", "QC name" and "Item name", then select QC lot number from "
", and QC result will be displayed as "point" on "QC Diagram". X-axis is test date, and y-axis is
concentration.
Click " " and the display is as shown below:
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Fig. 7-3-3
Click " " to print the monthly QC report.
Fig. 7-3-4
Conduct out-of-control analysis for the QC data according to the multi-rule judgment benchmark of Westgard and
display analysis content.
After inputting, modifying, deleting or editing the content in the box on the right of out-of-control analysis, click
"Print", and then the content edited will be displayed below the QC diagram and will not be saved when exiting the
window of out-of-control analysis.
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Fig. 7-3-5
Select the corresponding "Data", "Name", "Lot number" and "Item" of QC result from the pull-down menu, and
input QC result in the "Result" input box, then click " " to add QC result.
Select the "Data", "Name", "Lot number" and "Item" of QC result to be modified from the pull-down menu, then
input the QC result in the "Result" input box, and click " " to modify QC result.
Select the QC result from the list, and click " " to delete the QC result.
Click " " to exit "Edit QC Result" window.
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Chapter 8 Operation of the Analyzer
8.1 Operation overview

See Table 8-1-1 for simple operation sequence of the Analyzer and chapter "8.2 Detailed operation" for specific
operation.
Procedures Window/ key Operation Cross index
1. Check before test —— Conduct pre-test check before power is supplied 8.2.1
2. Power on pure water supply Open faucet to power on pure water device and the
device and the Analyzer Analyzer
8.2.2
Software login System Input the user name and password on the window of
login software system login
3 Confirm the status of the
Analyzer Warning Refer to "Chapter 11 Analyzer Alarm and Disposal"
(1) Confirm the alarm message Confirm whether the temperature of incubation bath is 8.2.3
(2) Confirm the temperature of Status within (37.0±0.1)℃
the incubation bath column
4 Confirm the analysis item
parameters System Add the analysis item
(1) Add item setting Set and confirm the item parameters
(2) Setting and confirmation of System Confirm the calibration curve and K factor 8.2.4
item parameters setting
(3) Confirm K value Calibration
information
5 Preparation of reagent
(reagent information) Reagent Confirm the residual reagent volume of all items and
(1) Confirm the residual information residual test number
reagent Reagent Place reagent needed for test at corresponding position 8.2.5
(2) Preparation of colorimetric information
analysis items and electrolyte
item reagents
6 Setting of calibration item Calibration Confirm the name of item to be calibrated and analyzed
and QC item information Confirm the name of item to be applied with QC test
8.2.6
Quality
control
7 Registration and test of QC QC Confirm the name of item and QC solution level to be
management applied with QC test 8.2.7
Sending test Send QC test
8 Stat test
(1) Prepare sample, standard Place the sample, standard solution and QC solution at
8.2.8
solution and QC solution the sample reagent disk
(2) Send test command Start Test Execute "Start test" to analyze
9 During the test
(1) Monitor system System Real-time monitoring of Analyzer test state
(2) Sample dispensing monitoring
suspension and continuing Sample
(3) Emergency stop dispensing Edit samples during the test and click to start test
(4) Sample dispensing suspension
8.2.9
and
continuing
Emergency
stop
Sample
registration
10 Confirm test results Test result Inquire, modify, delete, review and print test results
8.2.10
Check sample reaction curve
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Procedures Window/ key Operation Cross index

11 Test recheck sample Test result Confirm the condition of recheck item, click "Start
8.2.11
test" to send recheck instruction
12 End analysis
(1) Reconfirm results Test result Confirm, verify and print review results
(2) Database backup System Regular database backup is suggested to be done once
(3) System sleep management a month under normal conditions
8.2.12
(4) Cut off power supply The Analyzer will automatically wake at set time
(5) Prepare before next work Cut off power supply of the Analyzer, computer and
water purifier
Arrange and clean the Analyzer for next time use
8.2 Detailed operation

8.2.1 Check before test
Conduct following checks before test:
(1) Check if the power source is available.
(2) Check the communication cable and power cable among the Analyzer, computer and printer, and ensure the
connection is correct and free of looseness.
(3) Check if there are sufficient print papers and install the printer papers if they are insufficient.
(4) Check if there are water drops, silts and dirt, and twists of the probe, mixing bar, and nozzle of the rinsing
mechanism.
(5) Check if the detergent is sufficient, if it needs exhaust air or execute maintenance action of rinsing the probe,
CXL PROanti-bacterial phosphor-free detergent shall be place in outer 01 position of the sample reagent disk. Refer
to "10.1.3 Detergent" for detailed introduction of detergent.
(6) Check if the pure water in the tank is sufficient; if no, please add pure water according to "2.3.5 Pure water
filling" chapter.
(7) Check if the waste liquid tank is drained. If it needs to drain the waste liquid, please refer to "2.3.6 Waste liquid
drainage" chapter. If the waste liquid device of the Analyzer is connected to the water drainage system directly, such
operation is unnecessary.
See 10.4.10 Waste liquid treatment for disposal of waste liquid.

(8) Check whether there are foams in the sample-dispensing syringe pump (liquid leakage or foams will lead to
inaccuracy of data).
Deem the detergent as a corrosive liquid. Once skin or eye contact occurs, flush the area well with water.
8.2.2 Connect power cable and log in the software
(1) Connect the Analyzer power source. The switch at lower right part of the Analyzer with power socket is general
power supply switch and the switch shall be normally opened when there are reagents in sample reagent disk to
ensure continuous operation of refrigeration system. The switch at lower right part of the Analyzer without power
socket is the switch of analysis division.
(2) Log in the Analyzer application software and execute online command first to carry out test.
8.2.3 Confirm the state of the Analyzer
8.2.3.1 Confirm the alarm
(1) View alarm information and alarm prompt
When the Analyzer gives an alarm, the alarm icon " " will flash. If view of alarm information is needed, click
alarm information icon to enter alarm information window; if view of history alarm information is needed, it can be
done in "System log" on "System management" window.
(2) Text display of alarm information
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In case of an alarm at the Analyzer, alarm code, level, brief description of alarm information and time will be
displayed. The interface is as shown below:
Fig. 8-2-1
If to view details of alarm record, click the information bar through mouse, and the detailed description as well as
solution of the alarm will be displayed in the text box below. The interface is as shown below:
Fig. 8-2-2
User shall refer to solutions to handle problems. If the fault cannot be eliminated, please contact customer service
staff.
(3) Delete alarm information
Click " " to display the alarm information under current status.
Click " " and all alarm records displayed on "Alarm information" window are deleted; click
alarm information to be deleted, and then click " ", and the alarm information will be deleted.
(4)Set alarm information
Click " ", the following dialog box will pop up:
Fig. 8-2-3
After the alarm information is ticked, even if the selected alarm information is triggered when re-sending the test,
the content will not be displayed on the alarm information interface.
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The " " button is only displayed when the administrator with permission logins, or it will
be hidden to others.
(5)Click " " to exit the current window.

8.2.3.2 Check light intensity
Click " " icon on the "System maintenance" window to check the light intensity. Select "
" from "Cuvette blank and light intensity" window, and the display is shown as below:
Fig. 8-2-4
Click " " button, and the Analyzer will automatically execute the check of light source energy,
and display the check value of this time and before, and the difference value automatically calculated can be printed
as needed.
Halogen lamp will go aging in the using process, and the check value will gradually increase. The light intensity
value of the wavelengths shall be checked less or equal to 18,000, and 340nm for the biggest under normal condition.
If the light intensity value is checked not conform to requirements, please replace the light source lamp, refer to
"10.4.3 Light source lamp" chapter for details.
8.2.3.3 Confirm cuvette blank
Click " " on the "System maintenance" window to execute test of cuvette blank. Select "
" from "Cuvette blank and light intensity" window, and the display is shown as below:
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Fig. 8-2-5
Click the " " button, then the Analyzer will automatically execute cuvette blank test of 56
cuvettes and display the test results on the cuvette blank test window.
Click the " " button to preview and print the cuvette blank value if needed.
The cuvette blank test value of Cuvette 1 shall be inside 8000-18000, and the cuvette blank difference between other
cuvettes and the first cuvette shall be between -1500~1500. Replace the light source lamp if it fails to meet the
requirements. Refer to "10.4.3 Light source lamp" chapter for details.
New cuvette shall be soaked in 2% CXL Pro anti-bacterial phosphor-free detergent for over 8 hours before using,
and be rinsed with tap water repeatedly, and then installed on reaction disk after rinsing with pure water to execute
the cuvette blank test, and the test can only be executed until cuvette blank is checked to be qualified.
8.2.3.4 Confirm the temperature of incubation bath
Observe the temperature display in status bar at the left top of screen. Confirm whether the temperature inside
incubation bath is within (37±0.1)℃. If the temperature exceeds (37±0.5)℃, an alarm at caution level will be given
while the Analyzer will continue to analyze. If the temperature of incubation bath exceeds 40℃ under the standby
status, an alarm at caution level will be given by the Analyzer.
Once powered on, the temperature of incubation bath will stay stable at (37±0.1)℃ for about 25min, and the
light source requires several minutes to stay stable. Therefore, before the Analyzer enters in standby status
after startup, browse of window information, input of item parameters and view of alarm information can be
realized, and the sample test can only be carried out after standby is displayed in status bar.
8.2.4 Confirm analysis conditions
Before the test, maintain the item, and then set analysis parameter, calibration parameter and range parameter.
Refer to the specification or consult relevant manufacturer or distributor for parameter setting, usage, precaution and
preservation of reagent, standard solution and QC solution used for analysis.
8.2.4.1 Confirm the colorimetric item analysis conditions
(1) Maintain item (add and delete item)
Before parameters are set, maintain the item first, namely, add an item. Click " " in the functions
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area, and then click " ", and add, revise and delete colorimetric item, manual item, serum information and
ion item on the item maintenance window. Refer to "5.1 Item maintenance" chapter for details.
The item names and numbers cannot be repeatedly used, if adding the same item from different factories is needed,
please distinguish them with alphabets or numbers. The same sample shall be tested according the item numbers
from the smallest to the largest.
(2) Confirm item parameters
Set or confirm the reagent item parameters according to the reagent instructions. Some parameters must be provided
for test conditions, such as: name of the test item, analysis methods, test time, metering point, main wavelength/sub-
wavelength, sample volume, reagent volume, reagent position, calibration type, calibration point, position and
concentration of standard solution. Although some parameters do not affect the test results, they have important
significance to measure the reliability of test results, such as linear range and absorbance boundary. It is suggested
that operators input the correct parameters in sequence before carrying out the test.
Click " " in the functions area, and then click " ", and set the item analysis parameters,
calibration parameters and range parameters according to the reagent instructions. Refer to "5.2.1 Colorimetric item
analysis parameters" chapter for details.
(3) Set item combination
Item combination is to combine relevant items. To conduct complete liver function set and kidney function set, click
combination name to register several items.
Click " " in the functions area, and then click " " to set the item combination. Refer to
"5.4 Item combination" chapter for details.
(4) Set calculation and compensation item
Calculation item is a function that the test result of another new item calculated by making use of the test results of
Item A and Item B, or more items. Compensation item is a function that the test result of an item is calculated
through compensation calculation with numbers or test results of other items.
Click " " in the functions area, and then click " " to set the calculation and compensation
item. Refer to "5.5 Calculation and compensation item" chapter for details.
(5) Set cross contamination
Cross contamination is a function used to reduce or avoid cross contamination among analysis items. Including
cross contamination among probes, and cuvettes.
The reagent formula among some items may affect the analysis results of other items in the analysis process.
Pollution levels vary depending on the reagent. Refer to consultation of reagent manufactures and
distributors for more details. It is suggested that the operator can set the reagents with cross contamination
separately, if they cannot be completely separated, set cross contamination to reduce cross contamination
among items.
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Click " " in the functions area and then click " " to set the cross contamination. Refer to
"5.6 Cross contamination" chapter for details.
(6) Confirm calibration K factor
If 1-point linearity method is used in the test, click "Calibration information" in the functions area, and then click
"Calibration result", and the display is shown in the following figure:
Fig. 8-2-6
Input a factor in the "K" field, click the "Enter" button on the keyboard to save the modified value.
8.2.5 Prepare reagent (reagent information)
Please select the matching reagent produced by AGAPPE Company (See Appendix C) or reagent tested by
AGAPPE Company. The Company will not be responsible for inaccurate test results caused by failure to use
matching reagent.
8.2.5.1 Prepare colorimetric items
(1) Reagent use and precautions
a) Preparation, use and storage of reagent shall be in strict accordance with the requirements of reagent
specification to avoid foaming. As the reagent contains surface active agent, violent vibration will lead to foams.
During the test, the probe's liquid level sensor's contact with foams is mis-deemed as contact with the reagent,
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which will lead to inaccurate intake of reagent and further affecting the test results.
b)Reagents from different manufacturers, of different lot numbers cannot be mixed.
Dispensing of reagents from different manufacturers or different lots from the same manufacturer will cause
changes in reagent ingredients, resulting in inaccurate test results.
c)Turn the sample reagent disk cover in anticlockwise direction, and open the cover, then put the reagent bottle in
the corresponding position on the disk. If there is a barcode on the reagent bottle, confirm if there is pollution or
falling of the barcode.
Reset first before the Analyzer selects the barcode, and as the probe mechanism and mixing mechanism etc.
will start, the cover of reagent disk shall be closed. Please do not put your hands in the movement sphere of
the Analyzer as it may cause personal injury.
(2) Manually register reagent
Click " " in the functions area and the display is as shown below:
Fig. 8-2-7
Click " " in the "Reagent Info" window, and the display is as shown below:
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Fig. 8-2-8
a) Select the reagent position from the "pos." pull-down list, outer position 01~40 in the central circle can be
selected, and inner position 01~40 in the inner circle can be selected.
b) If manual registration with the item names is needed, click to select "reagent name", and then select the item
name from the "reagent name" pull-down menu, reagent type from the "type" pull-down menu, and reagent bottle
specification from the "bottle specification" pull-down menu. After inputting is completed, click "
", and the reagent information will be displayed in the reagent registration list area.
When executing reagent registration, ensure that the Analyzer is online and under the standby status. It is
not allowed to delete reagent information by the Analyzer during the test.
(3) Scan barcode
a) Register through manually inputting barcode
If the reagent information of reagent bottle cannot be scanned out due to the barcode pollution or falling, it can be
registered by manually input the barcode. Click to select "Barcode", and input 17 valid reagent barcode numbers,
and then click " ", and the reagent name, type, reagent bottle specification etc. will be
automatically registered.
The reagent can be supplemented during the test: select the reagent disk number and position to be supplemented
in "Reagent Registration", and select "Barcode" to input the barcode number of the supplementary reagent, and
then click " " to complete the supplement.
b) Register through automatically scanning barcode (mainly used under closed mode of reagent bottle)
If the barcode on the reagent bottle is clear and completed, the reagent information can be automatically registered
using "Reagent Barcode Scanning".
Before scanning the barcode, set the barcode item first. Select the "Item Maintenance" interface from "System
Setting" in the functions area, and input item numbers for recognizing the names of different items in "Barcode
Number" input field, and No. 01~99 respectively represent the names of different items.
Under closed mode of the reagent channel, the regent bottle with reagent barcode can be placed in any position of
the sample reagent disk, however, it shall be put in the correct sample reagent disk according to reagent type.
Select correct reagent position on the "Reagent Registration" window, and execute " "
button to start automatic scanning the barcode by the Analyzer, and the barcode information will be automatically
registered in the Reagent Registration list area. If the Analyzer fails to scan the barcode, it shall automatically
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conduct scanning of the same position three times, if it still fails, the failure will be displayed in the alarm
information.
(4) Scan residual regent volume
The residual reagent volume shall be scanned after the reagent information registration is completed. Click the
corresponding items in the "Scanning" column, namely: " ", select the
items to be scanned, and then click " " to start the residual reagent volume scanning in the
reagent positions selected by the Analyzer. If scanning of all the positions registered is needed, click to select "
", and if " " is selected, the Analyzer will scan the residual reagent volume of
all the positions (including positions not registered). Click " " to cancel all the items selected.
(5) Display residual reagent
Click the " " icon on the "Reagent Info" window to enter the reagent browse window, and the display is as
shown below:
Fig. 8-2-9
Select the item name from the "Name" pull-down list below the window, and the selected items can be browsed. If
printing of the browse interface is needed, click " ", and the display is as shown below:
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Fig. 8-2-10
Click " " to print the current list, and click " " to return to the reagent registration
menu.
(6) Print reagent information
If printing of the reagent information is needed, click the " " button, the disk No., position,
reagent name, reagent type, bottle specification, residual volume, remaining test times, proportion of residual
volume, expiry date, bottle No., barcode, etc. will be displayed in "Reagent Info Summary". The interface is as
shown:
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Fig. 8-2-11
Click " " to print the current list, and click " " to return to the reagent registration
window.
● Reagent information shall be deleted under the standby status.

● If registration through scanning the barcode fails, the reagent information shall be manually registered.
● After the reagent information is registered, please execute horizontal inspection of reagent to confirm
residual reagent and remaining test times.
(7) Delete reagent information
If deleting of the registered reagent information is needed, select the reagent information, and then click the
" " button.
It is not allowed to delete reagent information by the Analyzer during the test.
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8.2.5.2 Reagent-dispensing pause function
Fig. 8-2-12
If the reagent is insufficient during the test, reagent dispensing can be conducted in the test, detailed operation is as
shown below:
(1) Click the " " button, and the Analyzer prepares to enter the reagent-dispensing pause
status, and " " is displayed;
(2) When the status turns into " ", reagent dispensing can be executed,
and as well as subsequent operations after reagent dispensing is completed, such as residual volume scanning and
barcode scanning of the reagent.
(3) After reagent dispensing is completed, click " " to continue the test.
8.2.5.3 Reagent charging function
Under closed mode of the reagent, login the system with super user, select "Enable item charging function" on the
"Other Info." interface, and then click " " in the functions area to enter the " " window,
and the display is as shown below:
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Fig. 8-2-13
(1) Reagent charging of colorimetric items
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Fig. 8-2-14
Input the reagent barcode information into the input box, and then click " " to complete the setting
of reagent charging.
8.2.6 Registration of calibration item and QC item
(1) Register calibration item
Click the "Calibration Info." button in the functions area, and click the "Calibration Registration" button on the
calibration information interface, and then click the "Register" button. The calibration information will be displayed
in the calibration registration list area after successfully registered, and then click to select the calibration
information, and set the concentration and position of the standard solution of the calibration item on the right side
of the list. Refer to "Chapter 6 Calibration information" for specified operations.
Execution status shall be selected for the calibration item.
(2) Register QC item

Click "QC Management" in the functions area, and click the "QC Registration" button to enter the window so as to
register the QC name, QC lot number, QC item, sample type etc., and set target value and standard deviation of QC.
Refer to "7.1 QC Registration" chapter for details.
8.2.7 Sample registration
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Click " " in the functions area, and then click " ", and the display is as shown below:
Fig. 8-2-17
Click the " " button to close the window as needed.

(1)Registration of a single sample
a)Select test type: routine, emergency
If regular sample registration is needed, select test type " "; if emergency sample registration is
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needed, select test type " ".

b)Input sample ID and barcode ID No.
Sample ID: input sample No. in the "Sample ID" input box, or click the " " button and "
" button to select the sample No.. The routine sample No. is 1~9000, and the emergency sample
No. is 9001~9999. There is only one sample number on a very day.
Barcode ID No.: the barcode on the out wall of the tube. For use of barcode scanning function, the related barcode
value will be shown in the input box of "Barcode No."; if the barcode scanning function is not to be used or when
the barcode information cannot be worked out, the operator can input effective sample barcode in the input box of
"Barcode No.". If the input box of "Barcode ID No." displays "??", it indicates that the valid barcode information
is not scanned by the Analyzer.
c) Input disk No. and position
Select the test sample disk No. from 1~9 in the "Disk No." pull-down list (front). Select the sample position No.
from 01~40, outer 01 from the "Position No." pull-down list.
After the emergency sample is registered, click "Send Test" directly, then select "Emergency Test" and input
initial sample No. to start emergency test.
If the disk No. changes during the test, the Analyzer will automatically enter the sample-dispensing pause status,
but the analysis continues. Click "Continue to dispense samples", and the probe will continue to dispense samples.
d) Select sample and cuvette type
Select the sample and cuvette type for test from the pull-down box. means setting as default.
e)Input times of retests
The retest times of the same sample defaults to once, and 100 times for maximum.
f)Name of sample test item
Select the item name of sample for the test in the working area (color of the test item changes after selected).
g)Select sample volume: Normal, Decrement and Increment
h) Select whether the sample is diluted
If sample dilution is needed (such as hemolysis, lipemia and icterus), select " " on the "Analysis
Parameter" interface in "Item Parameters" of the "System Setting" window, and all the test items of the sample in
the test process shall be diluted; if only some of the items need to be diluted, select "Dilution" on the "Sample
Registration" interface first, namely, " ", and then select the item name to be tested, and then Select
Dilution Scheme interface will pop up, and click the dilution scheme as needed, and then click the "OK" button,
the display is shown in the following figure:
Fig. 8-2-18
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Click the " " button, and select the items which need to be diluted, and the button color changes.
Valid sample volume for analysis, sample volume for dilution and dilution solution volume shall be set on the
"Analysis Parameters" interface for the dilution function.
When registering, select dilution ( ) first, and then select the item.
i) For item selection, a single item or combination items can be registered as needed, the button color will change
after selected. Refer to "5.4 Item Combination" chapter for details of its setting.
If there is no parameters set on the "Analysis Parameter" interface in "Item Parameters" of the "System
Setting" window, the item name in the item information of "Sample Registration" will be shown in gray, and
the item cannot be selected.
j) After sample information is edited, click the " " button, and the information registered will be
displayed in the browsing area on the right side. Click information bar in the browsing area to view the registered
information.
(2) Registration of batched regular samples
For registration of many samples to the same test items, the registration by lots can be used.
a) Select test type according to a) in "(1) Registration of a single sample"; b) input sample No. and barcode ID
No. (the sample No. is the initial sample No. for batched registration); c) select sample disk No. and position; d)
select sample and cuvette type; e) select item name for the sample test; f) select sample volume; g) select whether
the sample is diluted. Register the initial information of batched regular samples.
b) Click the " " button on the "Sample Registration" window, and the display is as shown below:
Fig. 8-2-19
Input the end sample No. in the "End Sample No." input box, and the ending sample No. shall be bigger than the
starting sample No..
Or input in "Batch Sample No.": input the number of batched samples in the input box after the batched sample
number.
c) Click the " " button to complete registering the batched samples.
If the samples of batched registration contain samples of single registration, the Analyzer will prompts that the
batched registration is failed, and the display is as shown below:
Fig. 8-2-20
Register the batched samples again.
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d) Click " " to exit the current window.
When registering the regular samples with batches, register sample information first, and then register the
patient information.
(3) Editing of patient information
Click the " " button on the "Sample Registration" window and the system will shift to the patient
information input status as shown below:
Fig. 8-2-21
a) Input sample No. in the "Sample No." input box, or select it by clicking the " " and
" " button.
b) Select or input the case No, name, sex, age, clinic type, test department, sending doctor, nationality, inspector,
section, ward, bed No., sampling date, sampling time, sending date, sending time, clinical diagnosis, remark,
auditor, etc.. Mnemonic can be used when registering, press "Enter" key to confirm.
When editing the patient information, input the patient's name, or the registration cannot be permitted.
c) After the editing is completed, click the " " button to save the information, and the patient
name will be automatically displayed in the browsing area.
d) "Patient Info." of the last sample or the next sample can be edited through clicking the " " or
" " button.
e) Press the " " button, and the display is as shown below:
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Fig. 8-2-22
Input numbers in the editing order input box to set the order for displaying the patient information editing.
f)Click " " to close the "Patient Info." window as needed.
Under the condition of not inputting the patient information, the defaulted normal reference value range can
be displayed in the test results.
(4) Manual application for LIS
" " can be used when LIS communication function has started.
(5)Modification and deletion of sample information
If modifying sample information is needed, click the information bar in the browsing area, or click the "
" and " " button to directly input sample No. to be modified the in "Sample
No." input box. If deleting sample is needed, click the " " button on the "Sample Registration" window,
and a deleting confirmation window will pop up as shown below:
Fig. 8-2-23
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Input starting sample No. to be deleted in the "Starting Sample No." input box, and input ending sample No. in the
"Ending Sample No." input box. If to delete one piece of sample information, input the same sample No. in both
starting and ending input boxes, and the starting sample No. shall be smaller or equal to ending sample No.
● The registered samples without sending test can realize modifying and deleting under the standby status or
during the test. The registered samples that have been sent for test are only available to be deleted under
standby mode.
● Record with registered sample information but without patient information will be displayed as blue in
sample registration browsing area; record with registered patient information but without sample
information will be displayed as red in sample registration browsing area; record with both registered sample
information and patient information will be displayed as black in sample registration browsing area.
● For registering the samples, the sample positions of different samples can not be used at the same time, if to
use the same position, delete the original sample on this position first.
(6)Sample summary report
Click the button, and the sample registration condition will be displayed in the summary sheet when
the registered samples are ready to be tested, and test results after the test will be displayed in the report as shown
below:
Fig. 8-2-24
8.2.8 Prepare test
(1) Prepare detergent, standard solution, QC solution and sample

Put the regular samples, emergency samples, standard solution, QC solution, and detergent used for analysis on the
corresponding positions of sample reagent disk.
a) Place detergent
Before the test, if to execute air exhausting of the syringe pump and maintenance action of rinsing the probe,
please register CXL PRO anti-bacterial phosphor detergent position on the Reagent Registration interface, and
place the alkaline detergent diluted 1:5 with distilled water in the corresponding position of the sample reagent
disk.
b) Place standard solution
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Place standard solution in the corresponding position of the sample reagent disk according to the standard
solution position set on the "Calibration Registration" window.
c) Place QC solution
Place QC solution in the corresponding position of the sample reagent disk according to the QC solution position
set on the "QC Registration" window.
d) Place sample
Place samples in corresponding positions of the sample reagent disk according to the sample position set on the
"Sample Registration" window.
QC solution and standard solution shall be placed in standard cup or trace cuvette for the test.
(2) Start test
After sample registration is completed, click " " in the shortcut keys area to send the test command as shown
below:
Fig. 8-2-25
Click to select the test type, and click " " to start test of the Analyzer.
8.2.9 During test
(1) Monitor system
When the Analyzer is under operation, the sample reagent disk, reaction disk, LIS status, test samples, are under
real-time monitoring for the convenience of reviewing by the user.
Click " " in the functions area, and the display is as shown below:
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Fig. 8-2-26
Click " " to view the current status of the reagent and sample disk as shown below:
Fig. 8-2-27
a) Sample status
The left side of the window is sample reagent disk status area, and the "01 02 03 …10…40" is the sequence
number of Sample ID. If the Analyzer tests the sample at the corresponding position, the sample number and
current sample status will be displayed in the status area. Click a sample with mouse, then the sample position
number will be displayed on the right side.
Status legend:
 Free: no sample is registered in this position, in white color.
 Testing: the registered sample is under analysis status before test results come out, staring from sample
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dispensing, in pink color.

 Completed: results of all the test items of the sample in this position has been calculated out, in bright green
color.
b) Reagent status
Click reagent position to be viewed, and corresponding reagent information will be displayed on the right side of
the window.
Remaining times: the software shall automatically calculate the remaining test times of the residual reagent
according to the residual reagent volume and setting of sample-dispensing volume of reagent in analysis
parameters.
Residual volume: the current residual reagent volume is displayed in numbers, and the unit is mL.
Status description: the reagent status is displayed in different colors.
 Normal: the reagent is enough for the test, in light blue color.
 Insufficient: when the residual reagent is less than the volume set in "Reagent Alarm Setting" of "Other
Info." under the "System Setting" window, it indicates that the reagent is insufficient, in dark pink color.
 Loss: when the reagent volume in reagent bottle is 0mL, in red color.
 Not used: no reagent is registered in this position, in white color.
 Reagent closed: the reagent in this position must be an appointed brand, in shadow.
c)Click the " " icon to view the current status of the reaction disk as shown below:
Fig. 8-2-28
Click the reaction disk position to be viewed, and the corresponding information will be displayed on the right
side of the window.
Status: the status of current cuvette will be displayed in the display box, and meanwhile, the different statuses of
cuvette will display on the monitoring diagram of cuvette in different colors.
Status description:
 Free: no cuvette is used in current test, in white color.
 Testing: the solution in the cuvette is under testing, in light bule.
 Cuvette stained: the blank difference between the cuvette and benchmark cuvette for the test exceeds ±1500,
in red color.
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Sample No.: the sample No. in the cuvette under test. 0 is for QC test or calibration test.
Test item: the name of analysis item in the cuvette under test.
d) Click the " " icon to view the LIS communication status as shown below:
Fig. 8-2-29
This window displays the current connection status of the LIS system.
 Sample data
Click " ", and select the "Test Date" range on the window.
Select the "Test Date" range: select the detection time " ", and adjust the time through
clicking " ".
Click " " to refresh sample information.
Click " ", and all the sample data list displayed on the window will be deleted.
Unable to recover once the data is cleared!

 QC data
Click " ", and select the "Test Date" range on the window.
Select the "Test Date" range: select the test time " ", and adjust the time through clicking "
".
Click " " to refresh sample information.
Click " ", and all the sample data list displayed on the window will be deleted.
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 Communication log
Click " ", and select "Date" on the window.
Click " " to refresh log information.
Click " ", and all the log information displayed on the window will be deleted.
e) Click the " " icon to view statistics of tested samples. The interface is as shown:
Fig. 8-2-30
Click " " to refresh the sample test information list.
f) Click " " icon to view the current status of the each system of the Analyzer. The interface is as shown:
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Fig. 8-2-31
User can make real-time monitoring on the Analyzer status on the window.
Status can be read under the standby status only.

(2) Sample dispensing pause and continuing
Sample dispensing pause can only be executed during the test, and click "Sample dispensing continuing" to continue
the test as needed.
If the disk No. changes during the test, the Analyzer will enter sample-dispensing pause status, and click "Sample
dispensing continuing" to continue sample dispensing after the sample reagent disk is replaced.
When alarm of stop level of sample dispensing occurs, the probe will stop dispensing samples.
(3)Emergency stop
Click " " during the test, and the Analyzer will immediately stop current operation.
(4)Sample dispensing
a) Add new sample
During the test, the registration of other samples can be executed on the "Sample Registration" window, and after
registration, click " " to send the command for adding test.
b)Add new items for existing sample number
Click " " below "History Query" on the "Test Result" window, and select sample No. range,
sample volume, item name, whether to be diluted in the "Analysis Item" option box, and then click the
" " button. Send the "adding test" command through clicking " ".
It is available to add items of existing sample number under standby mode or during test.
8.2.10 Confirm test results
● The test results are affected by samples with hemolysis, lipemia and icterus.
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● The sample shall be ensured to be clear and free of clots, otherwise the probe will be blocked resulting in
severe consequence on test results.
● Some substances of samples, like medicine, anticoagulant or aseptic, will affect the test results.
● Do not keep the sample open for a long term, or it will volatilize and the test results will be affected.
● Incorrect parameter setting will affect the test result.
● Any violation against the User Manual during "System Maintenance" may pollute or damage the
Analyzer and further affect the test results.
● We do not suggest users modify or add the test results. The Company disclaims any due responsibilities.
Click " " in the functions area, and the display is shown as below:
Fig. 8-2-32
8.2.10.1 Result query
Click " " to view, delete, modify and audit the test results, to preview and print the report, and to recheck
and view the reaction curve, which is shown in Fig. 8-2-33.
(1) Intraday results
Select "Intraday Result" option button (default) on the "History Query" window to view intraday results, namely,
" ". All the intraday sample information will
be displayed on the "Test Result" window working workspace as shown below:
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Fig. 8-2-33
The window displays sample information on the left and test results on the right.
If there is no sample or reagent, the probe cannot aspirate sample or reagent normally, and the test result
may be incorrect. "S" means no sample, "R" means no reagent, and "!" means there is neither sample nor
reagent, and the result is marked with color. If test items are not calibrated, the results will by empty, and
alarm will be sent.
a) Modify result
If to modify a certain sample result, one is to click the test result of the sample in the test results area, then the
position will become gray, next input modified result, and press "Enter" to save the modification.
Select a certain item and right click as shown below:
Fig. 8-2-34
If "Mark modified test result (Y)" is selected, the modified test result will be displayed as"﹡" in "Modify"
column. If not, there is no modifying mark.
Another method is to click " ", and the display is as shown below:
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Fig. 8-2-35
When modifying analysis item result, select " " and the sample No. range from the pull-down
box, and then select items to be modified, then input revision value in "
".
Click " " to save the modification result.
When modifying manual item result, select " " and the sample No. range from the pull-down box,
and then select manual items to be modified, then input modified value in " ", and the display is as
shown below:
Fig. 8-2-36
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When modifying serum information item result, select " " and the sample No. range from the
pull-down box, and then select serum information to be modified, then input modified value in "
".and the display is as shown below:
Fig. 8-2-37

b)Dispense items
For registered samples, the analysis item and manual item can be dispensed no matter whether there are test
results. Click " " on the "History Query" window to enter item adding window, and then
select " " to dispense analysis item as shown below:
Fig. 8-2-38
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Select starting No. and ending No. of the analysis item sample to be added in the "Sample No. Range" pull-down
list;
Select sample volume type to be dispensed from the "Sample Volume" pull-down list, and confirm whether the
sample needs to be diluted, and " " means being selected; select the analysis item abbr. to be dispensed in
the Analysis Item Abbr. list; click " " to complete item adding.
If to send test of dispensed analysis items, click "Send Test", and select " " and starting sample
No., and then click " ".
Click " " on the "Add Item" window to dispense manual items. Select the starting No. and
ending No. of manual items to be added from "Sample No. Range" pull-down list, and then input the manual item
result in the " " column as shown below:
Fig. 8-2-39
Click " " to complete item adding. It can also be done through directly clicking
" " without inputting the manual item in the result column after the items are selected, and
then inputting modified result in test result zone of dispensed manual items on the history query window as shown
below:
Fig. 8-2-40
Press the "Enter" key to save the modified result.
The manual item information shall be registered on the "Item Maintenance" window first for adding manual
item result (including item No., item Abbr., and printing order), and then the manual item result can be added
in test results.
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c) Delete items
If to delete a test item, click the results to be deleted on the "History Query" window, and then click "
", and the dialog box for confirming deletion will pop up as shown as below:
Fig. 8-2-41
Select the starting sample No. and ending sample No. in the pull-down box, and select analysis item, and then
click " " to delete the record. If to delete all the items, click " " as needed.
The sample will be deleted if all of its items are deleted.

d) Reaction curve
If to view the reaction curve of a certain item, click " ". After entering the window, select
detection date, sample No., test item, repetitive times, curve type(regular or recheck), light measuring point to
view absorbance reaction curve of items that conform with the conditions as shown below:
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Fig. 8-2-42
If to view the absorbance value of each light measuring point, select light measuring points to be viewed from the
"Light Measuring Point" pull-down box, and the absorbance will be displayed.
e) Send data to LIS
When the Analyzer starts LIS communication, click " " as shown below:
Fig. 8-2-43
Select sample detection date from the "Test Date" pull-down box, and select "Routine" sample or "Emergency"
sample, and then select the starting number and ending number of the sample, then click " ",
and the test result will be sent to LIS system. If LIS function is not used, the function box will not be displayed.
f)Audit
For sample result audit, click " ", and select the starting sample No. and ending sample No.
from the "Sample No. Range" pull-down list. For a single sample audit, the starting sample No. is the same as the
ending sample No.; for batched samples audit, select the starting sample No. and ending sample No., and click "
" as shown below:
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Fig. 8-2-44
Click " " to exit the "Audit Sample" window.
● The sample information are to be audited only with results and names.
● The starting No. of the sample to be audited shall be smaller or equal to the ending No.
● User with view permission and operator permission cannot modify and delete the audited sample, and user
with administrator permission can modify the audited sample after canceling the audit.
● User with administrator permission can modify the intraday or previous test results, and user with
operator permission can only modify the intraday test result of his own.
g)Cancel audit
If to cancel the audited sample, click " " and input the starting No. and ending No. of the
audited sample to be canceled in the sample number range as shown below:
Fig. 8-2-45
Click " " to cancel the audited sample.
Click " " to exit the "Cancel Audit Sample" window.

h)Print report
Click " " and select test date, sample number range and whether to print the audited patient
report as shown below:
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Fig. 8-2-46
Fig. 8-2-47
If to print the report, click " " in the figure.
If not to preview, click " " on the "Print Sample" window to print the report.
If " " is selected, only the audited samples will be printed, while the
unaudited samples will not be printed; or both will be printed.
Click " " to exit "Print Sample" window.
The start sample number of batch printing should be less than or equal to the end sample number.
(2) Results within three days
Select "Results within three days" option button on the "History Query" window to view results within three days,
namely : " ". Refer to "8.2.10.1(1) Intraday result"
chapter for specified operations.
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(3) Results within a week

Select "Results within a week" option button on the "History Query" window to view results within a week, namely:
" ". Refer to "8.2.10.1(1) Intraday result"
chapter for specified operations.
8.2.10.2 History Query
Click the " " icon on the "Test Result" window to enter the history query window. The interface is as
shown:
Fig. 8-2-48
(1)Historical data query
Historical data can be queried according to the single or combination conditions. Query conditions comprise: date,
sample No., barcode, Case No., clinic type, patient name, sex, nationality, sending department, sending doctor,
testing doctor, auditing doctor, section, ward, bed No. and clinical diagnosis.
Input query conditions in the input box or select them in the pull-down list, then click " ", and the
specified record will be displayed in the result list.
Fig. 8-2-49
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Fig. 8-2-50
If to print the report, click " " in the figure.
If not to preview, click " " on the "Print Sample" window to print the report.
If " " is selected, only the audited samples will be printed, while the unaudited
samples will not be printed; or both will be printed.
Click " " to exit the "Print Sample" window.
"History Query" is mode window and must be closed by clicking " " after the query is finished.
(2)Historical results comparison
Click "Historical Results Comparison" on the "Historical Query" interface, and the display is as shown below:
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Fig. 8-2-51
The query can be conducted through case No. and barcode.
Select " " from "Query Condition", input the case No. of query samples, and input the test time range
of the query samples in the "Test Date" input box.
Select " " from "Query Condition", input the barcode of query samples, and input the test time range
of the query samples in the "Test Date" input box.
Fig. 8-2-52
It is available to click and select some certain items of the sample to query (five items for maximum), or click "Select
All", the Analyzer will automatically select the first five items of the sample. Click " " and the
result will be displayed in the list box.
Click " " to print the query result as needed.
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8.2.10.3 Result statistics
Click the " " icon on the "Test Result" window to enter result statistics window as shown below:
Fig. 8-2-53
(1) Repeatability statistics
a) Make statistics as per single sample
If to conduct statistics on repeatability of a certain sample on the "Repeatability Statistics" window, click
" ", and set the statistics conditions: test time, sample No., test item and repetitive times, then
click " ", and the results will be displayed in the statistics column on the right side of the
window. It is available to view the maximum, minimum, range, mean, SD and variable coefficient of the statistics
results for the convenience of confirming the repeatability of the Analyzer.
If to print the statistics results report, click " " as shown below:
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Fig. 8-2-54
Click " " to print the report according to the prompt.
The repeatability statistics cannot be conducted if no repeatability tests have been conduct for a single
sample.
b) Make statistics as per several samples
If to conduct repeatability statistics for multiple samples on the "Repeatability Statistics" window, click
" " as shown below:
Fig. 8-2-55
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Set statistics conditions: test date, sample No. range and test item, click " ", and the results
will be displayed in the statistics column on the right side of the window. It is available to view the maximum,
minimum, range, mean, SD and variable coefficient of the statistics results for the convenience of confirming the
repeatability of the Analyzer.
Fig. 8-2-56
Click " " to print the report according to the prompt.

(2)Statistics of positive rate in results
Click to enter the "result positive rate statistics" window as shown below:
Fig. 8-2-57
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Input the test date range and sample number range in the statistics condition.
Select either " " or " " or both the two means to make
statistics to the required sample test results.
Fig. 8-2-58
It is available to select statistics through clicking "Select all", the Analyzer will automatically select all the test items,
and then click " ", and the statistics results will be displayed in the list box.
Fig. 8-2-59
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Click " " to print the statistics report.

(3)Item statistics
Click to enter the "Item Statistics" window, set the statistics condition: test date range, and click
" " as shown below:
Fig. 8-2-60
Fig. 8-2-61
Click " " to print the item statistics report.
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(4)Workload statistics
Click to enter the "Workload Statistics" window as shown below:
Fig. 8-2-62
The workload statistics is purposed to make statistics of testing doctor, sending doctor and sending department. User
can select the test date range from "Statistics Condition" as needed, and click " " to complete
statistics analysis. Click " " to preview and print statistics report if needed.
8.2.11 Recheck of sample
There are two registration methods for sample recheck, i.e., automatic registration and manual registration where
the sample number will not be changed.
(1) Automatic registration
Click the " " icon on "Test Result" as shown below:
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Fig. 8-2-63
Click " " to set recheck conditions as shown below:
Fig. 8-2-64
Select " " of corresponding items, and click " ", and the Analyzer will automatically add the
sample information that meet the recheck conditions to recheck window according to the set recheck conditions.
(2) Manual registration
a) Manual registration of a single sample
If to recheck samples after initial test, select "Recheck" of the sample result column on the "History Query"
window to enter "Item Recheck", and the recheck sample will be automatically displayed in item recheck list. The
interface is as shown:
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Fig. 8-2-65
Set sample No., sample type, recheck item, disk No., position and whether to be diluted in "Recheck Info."
column, and click " ". If the setting is over, the modified disk No. and position of the recheck
item will be displayed in item recheck area.
Operator can manually modify sample type (normal, increment and decrement), and set sample dilution, and the
relation between item type and sample volume is shown below:
Automatic recheck conditions Sample volume type
Exceed technical lower limit Increment
Exceed technical upper limit Decrement
Reaction absorbance beyond the range Decrement
Prozone check value beyond the range Decrement
The absorbance of reaction solution exceeds 3.3ABS Decrement
● When the test meet automatic recheck conditions, and the item parameters of dilution, increment and
decrement have been set in the item analysis parameters, and the Analyzer will automatically carry out a
second test. The recheck results will be displayed in recheck result list of "History Query" after the test.
● When carrying out a recheck test, the sample shall be place in the set recheck disk No. and position first.
b) Manual registration of batched samples
Click " " on the "Item Recheck" window as shown below:
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Fig. 8-2-66
Select the sample number range to be dispensed from "Sample number range" pull-down menu. If a single sample
is to be rechecked, input same starting and ending sample number.
Select items to be rechecked, or click "Select All", and the Analyzer will automatically select all the items, then
click " ", and the sample will be added in the recheck list.
Set the sample No., sample type, recheck item, disk No., position and whether to be diluted in the "Recheck Info."
column on the right side, and click to save, and the sample information to be rechecked will be added in recheck
window.
Operator can manually modify sample volume (normal, increment and decrement), and set the sample dilution.
Before setting the sample volume, set content of "Sample Volume" in "Analysis Parameter" of "Item
Parameters" under the "System Setting" window first.
(3) Recheck test
After recheck registration is completed, click " " in the shortcut key area, and select test type " ",
and then click " " to start the test.
Only the intraday results can be rechecked.

8.2.12 Analysis ended
(1) Reconfirm results
After test of recheck samples, left click test results on the "Test Results" window, and right click "Replace the
selected results (V)", then the recheck results will be added in the "Test Results" column as shown below:
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Fig. 8-2-67
If there are more than 1 recheck items, click "Replace all results (W)", then all recheck results will be added in "Test
Results" column.
The recheck results will cover the initial test results after passing audit.
(2) Database backup
Database backup and recovery must be done under offline status.
Right click " " on the desktop under not login status, select Property, and then click "Search target (F)..." as
shown below:
Fig. 8-2-68
Double click " " on the interface as shown below:
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Fig. 8-2-69
Click to select " " to complete database backup according to the prompt.
(3)Database recovery
Refer to (2) Database backup for specified operations, click database document name to be recovered in "Database
Backup List" in Fig. 8-2-73, and then click " " to recover the database according to the prompt.
(4)System sleep
Sleep refers that the Analyzer is under half-stop status, and only refrigeration system and power of main control
board are under operating status, and the Analyzer will automatically enter the standby status through waking it.
Click to enter the "Other Info." window in "System Setting" under the standby status, and set the waking time of the
Analyzer, and then click "Sleep" as shown below:
Fig. 8-2-70
Click "Sleep" and the interface is as shown below:
Fig. 8-2-71
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Click " " to enter the sleep status of the Analyzer, and it will shut down all the power source except
refrigeration system and main control board, and the status column will prompt "Machine in sleep mode". The
Analyzer will automatically start up at the set waking time. Please log on again after startup.
The Analyzer software will automatically shift into offline status after sleep, if making it online, the status
column will prompt "Machine in sleep mode".
If to release from sleep status before the set waking time, click " ", and the status column will prompt
"Instrument in waking mode". Execute resetting operation after the Analyzer is waked up, and start the test under
the standby status prompted by the status column.
(5) Cut off power supply (shutdown)
Exit the software, cut off the power source of printer, computer host, display, analysis module of the Analyzer as
well as the main power source of the Analyzer (if there is reagent needing to be refrigerated, do not cut off the main
power source).
If the Analyzer has been executed system sleep, there is no need to cut off the main power source of the
analysis module as well as the Analyzer.
(6) Preparation for subsequent work
Check if the cover of the sample reagent disk covers up, take away the tubes or cuvettes with standard solution, QC
solution and samples in the sample reagent disk. Pour out the waste liquid in waste liquid tank, and check if there is
contamination and twists of the probes and mixing bar. Check if the worktable of the analysis module and operation
module of the Analyzer is contaminated, or clean them up.
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Chapter 9 System Help
In case of any doubts to the functions and operations during use, the operator can click " " or press "F1" to open
system help as shown in Fig 9-1 below:
Fig. 9-1
9.1 Use of system help
(1) Click the title name to be viewed in the list to view the specific operations. If the descriptions are not displayed
completely, drag the scroll bar to view the contents.
(2) After reading, click "Close" to end the help.
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Chapter 10 System Maintenance
10.1 Preparation before system maintenance

To guarantee the accuracy and precision of the Analyzer, operators shall strictly follow User Manual of Auto-
Chemistry Analyzer (Type: MISPA CXL PRO) and regularly provide maintenance for the Analyzer so as to get
reliable test results and ensure the Analyzer with planned service life.
Before maintenance of the Analyzer, please prepare the following tools:
10.1.1 Tools and instruments
(1) Accessory (accompanying)
Tool Name Use

Cross screwdriver To remove and install cover
Probe unblocking needle To clean probe
Probe unblocking tool To clean when probe blocked
Fixing block To adjust the height of mixing bar
(2) Objects prepared by users
Tool Name Use

Clean gauze To clean all parts
Cotton swab To clean probe

Dust collector To clean the cooling fan
Water tanks (two) To drain waste liquid
Brush of test tube To clean rinsing bath
10.1.2 Pure water

During routine operation and system maintenance, the Analyzer shall be filled with pure water with conductivity
lower than 1μs/cm. Don't forget to maintain and check the pure water unit regularly during using pure water unit.
Refer to the User Manual of the pure water unit for details to contact with the manufacturer or seller.
10.1.3 Detergent
Various detergents, used for rinsing all parts of the Analyzer, shall be purchased from AGAPPE Company. If the
detergents are replaced with any other detergent, cuvette, probe, mixing bar and tubing may be not rinsed fully,
leading to the impact on the accuracy and precision of testing result. The Company will not be responsible for any
inaccuracy due to failure to use detergent specified.
There is only one kind of CXL Pro detergent in total:
(1) alkaline detergent: place CXL PRO alkaline detergent in the detergent bottle in front of the Analyzer for rinsing
cuvette
(2) Diluted alkaline detergent: Put CXL PRO alkaline detergent in the specified position according to the prompt
at 1:5 dilution with distilled water. 1% of CXL alkaline detergent shall be adopted for scrubbing parts of the
Analyzer or soaking cuvette.
10.2 of "System Maintenance" window
Click " " in the functions area to enter maintenance window, and then set the daily maintenance
as per the demand. The interface is as shown:
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User Manual
Fig. 10-2-1
During the maintenance operation of the Analyzer, click " " in the window to stop maintenance
operation that can be stopped halfway, or execute other operation until maintenance operation is finished when some
maintenance operation cannot be stopped halfway. The Analyzer will reset first before executing any maintenance
item. In case of any abnormal mechanism during maintenance, an alarm prompt will be displayed in the "Alarm
Information" window.
Click " " to exit some maintenance window.

10.2.1 Reset analyzer
Click the icon on "System Maintenance" as shown below:
Fig. 10-2-2
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Click " ", and the mechanism of the Analyzer will automatically return to the reset point. It is not
allowed to suddenly suspend the reset process. Other operations are allowable only under standby mode.
Please execute reset if the alarm information gives prompts, or the Analyzer is suddenly suspended, or single-step
adjustment of probe, or mixing mechanism is executed.
10.2.2 Check cuvette blank and light intensity
Click the " " icon on the "System Maintenance" window to execute test of cuvette blank and light
intensity.
(1) Cuvette blank test
Select " " on the "Cuvette Blank and Light Intensity" window, and click
" ", then the Analyzer will execute cuvette blank test of 160 cuvettes and display the test results
on the cuvette blank test window as shown below:
Fig. 10-2-3
Click the " " button to preview and print the cuvette blank value if needed. During the check of
cuvette blank, click the " " button to end cuvette blank test.
Normally, the user is suggested to execute cuvette blank test once a week. User shall execute cuvette blank test after
replacing cuvette only if the value is qualified. Operator is not suggested to continue sample test if the cuvette blank
value is abnormal, otherwise, it may affect the accuracy of test result.
a) "cuvette No." column: display the number of 1~56 cuvettes.
b) "340~380" column: separately display the cuvette blank test of 56 cuvettes of different cuvette No.
corresponding to wavelength of 340nm, 380nm, 405nm, 450nm, 480nm, 505nm, 546nm, 570nm, 600nm, 660nm,
700nm, 750nm, or 800nm.
c) "1" (cuvette) line: display the cuvette blank value of No. 1 cuvette under 12wavelengths, which is qualified if
the value is in the range of 8000~18000.
d) "2~56" (cuvette) line: display the difference between cuvettes of No. 2~56, which is the difference between
cuvette blank of No. 1 cuvette and cuvette blank of No. 2~56 cuvette, and the difference is only qualified within
the range of -1500~1500.
(2) Check quantity of light
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Select " " on "Cuvette Blank and Light Intensity" window, and the display is shown as
below:
Fig. 10-2-4
Click the " " button, and the Analyzer will automatically execute the check of light source
energy, and display the check value of this time and before, and the difference value automatically calculated can be
printed as needed. The check value of quantity of light shall be less than or equal to 18000. Click the "
" button to end the check of light intensity.
Normally, users are suggested to check quantity of light once a month. Check light intensity first after replacing
halogen lamp, and only when the value of light intensity is qualified can the test be carried out.
10.2.3 Exhaust air
Click the " " icon on the "System Maintenance" window to execute air exhaust of syringe pump as shown
below:
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Fig. 10-2-5
Select " " on the "Air Exhaust" window, and select " " or "
" as needed. If to select "Detergent aspirating", place CXL PROanti-bacterial phosphor-free
detergent in position outer 1 on the sample reagent disk. Click " ", the syringe pump piston will
twitch up and down repeatedly to exhaust the air in syringe pump or tubing. Emergency stops are not allowed during
this function operation, and any other operation shall be carried out under the standby status.
Exhaust air from syringe pump for several times when replacing syringe pump or its tubing or firstly install the
Analyzer.
10.2.4 Rinsing
Click the " " icon on the "System Maintenance" window to rinse cuvette, and drain the whole machine, as
shown below:
(1) Rinse cuvette
Click " " on the "Rinsing" window as shown below:
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Fig. 10-2-6
Click" ", and the Analyzer will automatically rinse 56 cuvettes. During rinsing cuvette, click
" " to end the operation.
In case that the cuvette blank value is abnormal, execute "Rinse cuvette" first; the user is suggested to rinse cuvette
once a week to protect the test result from being affected by polluted cuvette.
(2) Drain whole machine
Click " " on the "Rinsing" window as shown below:
Fig. 10-2-7
Click the " " button, operate according to the prompt, and wait for standby before executing
other operation.
When executing "complete machine dewatering", the pure water in the water feeding tubing of the rinsing
mechanism, the probe inner wall, the probe outer wall, the rinsing bath, and the degassing tank will be drained, and
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the detergent in the alkaline detergent tubing will be drained. Detergent will be discharged from the inlet. Before
executing the function, prepare a container to hold the discharged detergent. Pure water will be discharged directly
to the low-concentration waste liquid tube.
(3) Probe rinsing
In the "rinsing" window, select " ", and the interface is as shown below:
Fig. 10-2-7(a)
Click the " " button. Operate according to the prompt. Wait for standby before executing other
operation.
It’s suggested that the user execute probe rinsing once a week.
10.2.5 Mechanism check
Click " " in the "System maintenance" window to execute the vertical check and horizontal check of probe
and check mixing mechanism, mechanical action and rinsing mechanism. Please execute corresponding
maintenance action to check or adjust the mechanism.
(1) Vertical check of probe
Select " " on the "Mechanism check" window as shown in the figure:
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Fig. 10-2-8
Click the " " button, and the Analyzer starts the single-step vertical action of lifting mechanism
of probe, then click the " " button to execute the next action, and click " "
button to stop the maintenance action.
Vertical check of "5mL", "50mL", "Empty Bottle", "Check out" or "Return to Zero" can be selected.
Please refer to "10.4.1 (4) Adjustment and confirmation of the position of probe" for the action of vertical check of
probe.
(2) Horizontal check of probe
Fig. 10-2-9
Click the " " button, and the Analyzer starts the single-step horizontal action of lifting
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mechanism of probe, then click the " " button to execute the next action, and click the "
" button to stop the maintenance action.
Please refer to "10.4.1 (4) Adjustment and confirmation of the position of probe" for the detailed specification of
horizontal check of probe.
Please execute the action when adjusting or checking the position of probe.
(3)Check of mixing mechanism
Fig. 10-2-10
Click the " " button, and the Analyzer starts the single-step action check of mixing mechanism,
then click the " " button to execute the next action, and click the " " button
to stop the maintenance action.
Execute when adjusting the position of mixing mechanism (at cuvette side and above the rinsing bath).
(4)Mechanical motions check
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Fig. 10-2-11
Input the number of check within the range of 1~65535, and click the " " button to execute
action check of all mechanisms. Click the " " button to stop the maintenance action.
(5)Mechanical motions check
Fig. 10-2-12
Click the " " button and the Analyzer executes the reset automatically, then the rinsing
mechanism goes off (failing distance: upon the rinsing probe enters into the cuvette); click "Next", the rinsing
mechanism goes up to zero; then click "Next", the rinsing mechanism goes down. Click the " "
button to stop the maintenance action.
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10.2.6 Water quality check
On the "System Maintenance" window click the " " icon to check the water quality, and the interface is as
shown below:
Fig. 10-2-13
Select "cal." and click the " " button, and according to the prompt put a 20mL reagent bottle
holding 20mL normal saline in position outer 1.
After calibration, put a 20mL reagent bottle holding 20mL water to be tested in position outer 1 accoding to the
prompt. After testing, the test result will be displayed on the software interface.
10.2.7 Barcode
Click the " " button on the "System maintenance" window to check the barcode of sample and reagent.
Select " " on the "Barcode" window as shown in the figure:
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Fig. 10-2-14
Click the " " button, the Analyzer will scan the barcode at position 1, outer 1 and inner 2 of the
sample reagent disk, and display the check result.
Before testing, put a test tube with barcode respectively at position 1 and outer 1 of the sample reagent disk;
after the scanning, put a test tube with barcode at position 1, and a 20mL reagent bottle with barcode at
position outer 1; and after scanning, put a test tube with barcode at position 1, and a 35mL reagent bottle
with barcode at position inner 2 for scanning.
10.3 System maintenance position and parts
If the Analyzer is installed with accessories which are not provided or recommended by the manufacturer or
the Analyzer is used otherwise specified by the manufacturer, the relating protection may be weakened.
10.3.1 Clean, check and replace parts regularly
Maintain, check and replace parts regularly as shown in Table 10-3-1 (providing the Analyzer is used for 5 hours per
day):
(○: Clean and check regularly ●: Replace and add regularly)
Table 10-3-1 List of Parts to be Cleaned, Checked and Replaced Regularly
Periodic
Necessary
Annual
No. Items amount for Appro Reference
consumption
1 time Daily priate Weekly Monthly Yearly
time
1 Standard cup ● ——
2 Manual-rinsing probe ○ 10.4.1

Probe rinsing tank
3 ○ 10.4.1
Rinsing bath of mixing bar
4
Cuvette (7/set) 8 groups 32 sets ● ○ 10.4.2
(Note a)
5 Incubation bath and axial fan ○ 10.4.2
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Periodic
Necessary
Annual
No. Items amount for Appro Reference
consumption
1 time Daily priate Weekly Monthly Yearly
time
6 Halogen lamp (light source
1 2 ● 10.4.3
(Note b) lamp)
7 Rinse nozzles of mechanism ○ 10.4.4
8 Mixing bar ○ 10.4.5

Rinsing of syringe pump
9 Sample dispensing in syringe ● 10.4.7
pump
Water supply filter and
10 ○ 10.4.11
detergent filter
CXL Pro anti-bacterial
11 phosphor-free detergent ● 10.1.3
CXL PROalkaline
detergent
12 Vacuum bottle body ○ ——
13 Refrigeration chamber ○ 10.4.6
14 Cooling Fans ○ ——
15 Confirmation of cuvette
○ 10.2.2
(Note c) blank
16 Drainage of waste liquid ○ ——
17 Detergent bottle ○ 10.4.2
Note:
a) Statistic about the maximum consumption is made in the list, if the cuvette blank value is qualified, it can
be used continually. Replace with a new cuvette if the cuvette blank value is still abnormal after rinsing
cuvette.
b) Halogen lamp, whose average service time is 2000 hours, needs to be replaced when the value of quantity of
light is tested with 340nm wavelength to be larger than 18000 hours, and to ensure the accuracy and precision
of test result, halogen lamp with service time of 750 hours are recommended for the replacement.
c) Execute cuvette blank test once a week, otherwise, warning of abnormal cuvette blank value may occur.
d) The Analyzer can be equipped with stylus, ink-jet or laser printer, and user can select consumables as per
the type of printer.
10.3.2 Spare parts for regular replacement and maintenance
Please prepare the following parts all the time for repairing the Analyzer at any time in case of faults. The parts are
shown in Table 10-3-2:
Table 10-3-2 List of Spare Parts
No. Part name Note Suggested qty./year
1 Halogen lamp 12V20W 2
2 Cuvette (7/set×8 sets) 32 sets
3 Axial fan F251RF05LC5V 3
4 LMT55 ethylene tube 1/4×3/8 (unit: inch)
5 LMT55 ethylene tube 1/8 inch×1/4 inch 5m
6 LMT55 ethylene tube 1/16 inch×1/8 inch 5m
7 Teflon FEP hard pipe 1mm×2mm 5m
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No. Part name Note Suggested qty./year
8 Teflon FEP hard pipe 1.5mm×2.5mm 5m
9 Teflon FEP hard pipe 2.1mm×3.2mm 3m
10 Silicone tube 8mm×14mm 3m
11 Water supply filter and detergent filter For tubing 1 piece for each
12 Probe For sample-aspirating 1
13 Mixing bar For mixing 2

Wiping white block of rinsing
14 For rinsing cuvette Two for each spec.
mechanism
15 Rinsing of syringe pump For water supply during rinsing 1
16 Sample dispensing in syringe pump For dispensing sample and reagent 1
10.4 Maintenance methods
● Don't spill water, reagent detergent or other solutions on the machine or electric parts of the Analyzer in
case of any damages.
● Do not touch probe mechanism, mixing mechanism or cuvette-rinsing mechanism during operation of the
Analyzer in case of infection or injury.
● During operation, the operators shall take preventive measures like wear protective gloves, glasses,
working suits in case of infection due to touch with polluted area or solution or skin injury due to contacting
with corrosive liquid. The operator shall rinse with water and take disinfection measures after contacting the
polluted or corrosive liquid due to carelessness.
● During maintenance process, please check whether there are hazards caused by inefficiency of hoses or
parts filled with solution.
10.4.1 Probe
The inner/outer wall of the probe may have serum, reagent or drops attached, or is easy to be blocked if being
polluted, as a result the test results of the Analyzer may be affected. Therefore, regular check and rinsing or cleaning
are needed.
(1) Daily automatic rinsing of the Analyzer
Place a reagent bottle (70mL bottle) with CXL PROanti-bacterial phosphor-free detergent at position outer 1 of the
sample reagent disk, as shown in the figure:
Fig. 10-4-1
When the filling finishes, the probe will automatically aspirate CXL PRO anti-bacterial phosphor-free detergent or
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CXL PRO alkaline detergent for rinsing.
Place detergent at stipulated position to avoid cross contamination of cuvette and probe during rinsing.
(2) Cleaning of probe tip surface
a) Turn off the power of the Analyzer.
b) Remove the cover of reagent disk, and move rotary arm of probe on the disk by hands, as shown in the figure:
Fig. 10-4-2
c) Wipe the surface of the probe with cotton swab dipped in alcohol, as shown in the figure:
Fig. 10-4-3
Don't put a large amount of alcohol near the Analyzer during use providing the alcohol is inflammable.
d) After powering-on again, the probe will automatically swing to resetting position.
(3)Cleaning of blocked probe and serious cross contamination
b) Hold the cope shell of the probe with fingers and then pick up to take it off as shown in the figure:
Fig. 10-4-4
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Unscrew tubing connector as shown in the figure:
c) Remove the probe.
Fig. 10-4-5
d) Connect the connector at the end of the probe unblocking tool with the that on the probe, as shown in the figure:
Take a clean cuvette and inject sodium hypochlorite detergent; then put the probe into the detergent in the cuvette
and pull the piston of the syringe to absorb the detergent; finally eject the detergent after 5 min.
Fig. 10-4-6
If failed to unblock the probe, soak the probe in hot water for 5 min, and pull/push the syringe piston repeatedly.
e) After step d), if the probe still cannot discharge liquid, the blockage is very serious, then the needle shall be
penetrated from the probe tip for cleaning again, as shown in the figure:
Fig. 10-4-7
Afterwards, repeat step d) with probe unblocking needle.
f) Ensure that the probe is properly installed and then turn on the Analyzer power switch to reset the entire
unit. After the Analyzer enters the standby state, if the test is performed, the power of the Analyzer needs to
be turned off again, and the power switch is turned on again after 10 seconds to prevent the liquid level
detection function from malfunctioning.
(4) Adjustment and confirmation of probe position
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a) Turn on the power source of the Analyzer.

b) Click the "Maintain" button in the functions area.
c) Select "horizontal check of probe" and "mixing mechanism" on the "Mechanism check" list, then click the
" " button and the " " button to move on the next action.
d) Conduct "horizontal check of probe", and when probe stops above the cuvette, check whether the point of probe
is at the center of cuvette, as shown in Fig. 10-4-8. If not, contact the maintenance personnel.
Fig. 10-4-8
e) Execute "mixing mechanism check", when mixing bar stops above the cuvette, check whether the point of
mixing bar is at the center of cuvette. If not, contact the maintenance personnel.
Overlook the position of probe and mixing bar relative to cuvette, as shown in the figure:
Fig. 10-4-9
Click the " " button to end the maintenance process.

Horizontal check process of lifting mechanism of probe:
Probe reset→upper part of cuvette→rinsing bath (with a pause)→sample reagent disk outer 1 reagent bottle
position (going downward)→rinsing bath above the cuvette (with a pause)→sample reagent disk position inner 2
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reagent bottle (going downward)→rinsing bath (with a pause)→repeat above steps.

Check process of mixing mechanism:
Mixing bar reset→above the cuvette→rinsing bath→above the cuvette→repeat the action process.
f)Vertical check of probe
Select "vertical check of sample probe" from "Mechanism check" on the "System maintenance" window, and
click the " " button, the probe will descend until its point touches the bottom of standard cup.
g)Vertical check of probe
During the vertical check of reagent probe, take three 70mL reagent bottles and fill 5mL and 50mL normal saline
into the 1st and 2nd bottle respectively, then place the reagent bottle with 5mL of normal saline in position outer
1 of the sample reagent disk, select corresponding reagent volume on the window, and click the "
" button. During test, the Analyzer will remember the height as the benchmark value for
calculating reagent left.
The normal saline must be used for the vertical check of probe, if the volume of liquid is not correct, alarm
prompt "wrong placing of reagent bottle for vertical check" will be sent.
(5) Cleaning of rinsing bath
a) If rinsing bath is polluted, use the tube brush or cotton swab dipped in 2% CXL Pro anti-bacterial phosphor-
free detergent for cleaning as shown in the figure:
Fig. 10-4-10
b) Fill about 10mL of 2% CXL Pro anti-bacterial phosphor-free detergent in the rinsing bath as shown in the
figure:
Fig. 10-4-11
c) Fill about 100mL of water in rinsing for washing.
After flushing, the dirt in the rinsing tank can be removed, and the bacteria can be inhibited to grow and breed.
Generally, the cleaning process shall be conducted once every month. The dirt of the Analyzer discovered during
use shall be cleared promptly.
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10.4.2 Reaction disk

Polluted cuvette or incubation bath may lead to inaccurate test result. In addition, clean the cuvette regularly and
check the cuvette blank value as it is going aging after long time of using; when warning of abnormal cuvette blank
value is given, clean cuvette in time.
(1) Dirt confirmation of cuvette
a) Turn on the power source of the Analyzer.
b) Execute cuvette blank test in "Cuvette blank and quantity of light" on the "System maintenance" window.
c) The cuvette blank value of Cuvette 1 shall be in the range of 8000-18000, and the test value of Cuvette 2~56
shall be within the range of -1500～1500, which is the difference with cuvette blank value of No.1 cuvette.
d) If the cuvette blank value is not qualified, execute the test after rinsing cuvette, if cuvette blank value still
exceeds the standard, the cuvette shall be replaced.
The cuvette blank value can be displayed and printed. But the Analyzer will not store cuvette blank value
tested.
(2) Rinsing of cuvette
The difference between cuvettes out of the range of -1500～1500 may be caused by polluted cuvette, and in this
condition the cuvette shall be rinsed. However, if cuvette cannot meet the demands after rinsing, it shall be replaced
in time.
a) Rinse cuvette through selecting "Rinse" from the "System maintenance" window.
b) After rinsing, execute cuvette blank test again. If the difference between cuvettes remains out of range of-
1500~1500, replace them with new ones.
To avoid being polluted after long time of using, soak cuvettes in 2% CXL Pro anti-bacterial phosphor-free
detergent for 8 hours every month, then wash the residual detergent on cuvette surface with clean water, and
wash the water with pure water . After the outer surface of the cuvettes is dry, install them on the reaction
disk. Test can only be executed until cuvette blank is checked to be qualified.
(3) Clean outer wall of cuvette
It is recommended to clean the outer wall of the cuvettes with glasses cloth once a week. Care should be taken not
to leave scratches on the outer wall of the cuvettes during cleaning.
(4) Replace cuvette
Please replace with new cuvette if cuvette blank value is unqualified after rinsing.
New cuvette shall be soaked in 2% CXL Pro anti-bacterial phosphor-free detergent for over 8 hours before
using, and installed on reaction disk after rinsing, and the test can only be executed until cuvette blank is
checked to be qualified.
b) Wear the protective gloves, take down the rinsing tip, then hold the reaction disk cover handle and lift it up
forcibly (do not shake it to left and right in a large range in case of damaging the pin), next take down the reaction
disk cover and put it at a clean place as shown in the figure:
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Fig. 10-4-12
c) Remove the fixing screw as shown in the figure:
Cuvette installation
disk fixing screw
Screw of cuvette
Fixing screw installation disk
handle
Fig. 10-4-13
d) Remove the cuvette as shown in the figure:
Fig. 10-4-14
e) Remove other cuvettes, then installed the new soaked cuvettes on the reaction disk. The 8 sets of cuvettes shall
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be replaced at the same time.

f) Turn on the power source of the Analyzer.
g) Execute cuvette blank test in "Cuvette blank and quantity of light" on the "System Maintenance" window.
Cuvette blank test must be executed after replacement of cuvette every time. The test can only be executed when
cuvette blank value is qualified.
● There will be contaminants on the cuvette wall if the used cuvette is exposed in the air for a long time.Thus
the cuvette shall be immersed in the pure water. In addition, take off the cuvette to soak it in pure water if
the Analyzer has not been used for more than 3 days in a row. If there is the emergency stop during testing,
rinse the unrinsed cuvette with pure water to prevent the reaction solution remaining on the cuvette for a
long time.
● Do not wipe the cuvette with or soak it in organic solvents (benzenes or ethanol).
(5) Cleaning of incubation bath, dust screen and axial fan
As the test result may be inaccurate if the incubation batch and axial fan are seriously polluted by downy or silky
dust, cleaning shall be executed every month.
a) Follow the "Replace cuvette" process of the above section, remove the reaction disk cover, then loosen the
fixing screw of cuvette installation disk, rotate the screw of cuvette installation disk handle in anti-clockwise
direction to a limited height, and lift and take down the cuvette installation disk and put it at a clean position.
b) Loosen the fan fixing screw, then take out the fan fixing rack and the fan, and clear the dust in the incubation
batch, dust screen and fan blade with brush and wet gauze as shown in the figure below:
Fig. 10-4-15
Prevent the water on the inner wall of the cuvette from dripping into the Analyzer. Otherwise, it may cause
faults of the Analyzer.
c) Wipe the metering window of incubation bath with clean and wet gauze, as shown in the figure:
Fig. 10-4-16
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Do not scratch or let sundries attached on metering window.

d) After cleaning, reinstall the fan, dust screen, cuvette installation disk and reaction disk cover.
e)Reinstall the rinsing head of the Analyzer on the original position and fix it.
f)Execute cuvette blank test in "Cuvette blank and quantity of light" of the "System maintenance" window, and
the test can only be executed when the cuvette blank value is qualified.
Screw the fixed knob of reaction disk tightly when installing reaction disk to ensure a reliable installation
and no loosening.
(6) Cleaning of detergent bottle
As CXL PROalkaline detergent is added at proper time into detergent bottle to maintain the daily usage, cleaning is
suggested to be executed every month because dust or crystal may exist after long time of using.
a) Turn off the Analyzer main power or perform this maintenance in standby mode.
b) Push the detergent replacing window forward slightly and stop once hearing the sound, then the window is
available to be opened as shown in Fig. 10-4-17: first turn on the detergent float switch, then tilt the detergent
bottle in the direction of the arrow and take it out and open the cover of detergent bottle. Please clear the bottle
when there is a little detergent.
Detergent float Detergent connector
Detergent replacing
window
Detergent bottle
Fig. 10-4-17
c) Clean the detergent bottle cover with a rag.
d) Take down the detergent bottle, and rinse the inner/outer wall of the box with detergent, wash it with tap water,
then clear it with pure water.
e) Pull out the filter assembly on the top of the detergent pipeline, use a cotton swab to push part 9 out from the
hole of installation part 6, use tap water to rinse the front and back of part 9 until there is no debris on it, and then
put it back in the original position after rinsing.
f) Wipe the water drips on the bottle surface with dry cloth, then fill the detergent bottle with 1LCXL PROalkaline
detergent and reinstall it.
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The detergent tubing shall be free of right-angle bending after the detergent bottle is installed or it will cause
blocking.
g) Connect the float switch again, and close the detergent replacing window.
h) Execute "Filling and flushing detergent tubing exhaust" in "Exhaust" menu on the "System maintenance"
window.
10.4.3 Light source lamp
The precision of the Analyzer will decline as the light power will be weaker due to the aging light source lamp.
Check quantity of light, if the check value is larger than 18000, replace halogen lamp in time.
(1) Check quantity of light
Execute "Check quantity of light" in "Cuvette blank and quantity of light" of the "System maintenance" window to
test the light source power of the Analyzer. The test results will be displayed as AD value or can be printed.
Generally, the value will reach its highest point at 340nm.
(2) Replacement of light source lamp
Method 1:
a) Prepare a new halogen lamp as shown in the figure:
Fig. 10-4-18
Do not touch the surface of the halogen lamp, otherwise, the light intensity value may be affected. If there are
stains such as fingerprints on the surface, wipe it with a piece of gauze dipped with ethanol.
b) Turn off the main power of the Analyzer and wait for a while until the lamp house is completely cooled down
(about 30 minutes), so as to prevent burns.
c) Screw off the fixing screw of halogen lamp replacing window at the left cover of the Analyzer and open the
window.
d) Screw off the two fixing screw of the halogen lamp leads and take down the leads as shown in the figure:
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Halogen lamp Halogen lamp

replacing window
Window fixing screw

Fixing screw
Light source holder

fixing screw
Fig. 10-4-19
e) Screw off the two fixing screws of light source holder and take down the halogen lamp.
f) Replace with a new halogen lamp according to the reverse steps of above and ensure that screws are screwed
down and leads are not loosen or up warping.
g) Fix the halogen lamp replacing window again and turn on the main power of Analyzer. After the standby,
execute the light amount test, if acceptable, replace the halogen lamp and conduct the testing.
10.4.4 Nozzles of rinsing mechanism
Unable to rinse cuvette or water overflow out of the cuvette due to the blocked nozzle of the Analyzer may lead to
the failure of the Analyzer or inaccurate test data.
(1) Anticlockwise screw out fixing screws on the rinsing mechanism to remove the cuvette rinsing mechanism.
(2) Wipe the outer wall of the nozzle with swab dipped in 2% CXL Pro anti-bacterial phosphor-free detergent, as
shown in the figure:
Fixing screw of
rinsing mechanism
Rinse nozzles of
mechanism
Wiping block of
rinsing mechanism
Fig. 10-4-20
Do not bend the nozzle, or replace with severely polluted or worn swabbing block during operation.
(3) Slightly rotate the swabbing block to pull it out. Install the swabbing block as shown in the figure: do not install
at wrong direction, and the bottom of swabbing block shall be parallel to the cuvette.
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Fig. 10-4-21
(4) Install the rinsing mechanism on its original position.
(5) Execute "Mechanical action check" for 10 times in "Mechanism check" of the "System maintenance" window.
The swabbing block shall not touch the cuvette. The rinsing water shall be near to the cuvette rim and not spill out of
the cuvette.
10.4.5 Mixing bar
Cross contamination caused by polluted mixing bar may affect the accuracy and precision of test result. Thus,
regular cleaning is necessary. In addition, replace mixing bar if it is bent.
(1) Cleaning of mixing bar
Wipe mixing bar with gauze dipped in ethanol, then wipe out the liquid on its surface with that dipped in pure water,
as shown in the figure: do not bend mixing bar during wiping.
Fig. 10-4-22
(2) Replacement of mixing bar
b) Loosen 2 fixed screws for about 1 circle, as shown in the figure: pull out mixing bar from the bottom.
Fig. 10-4-23
c) Prepare a new mixing bar, and wipe the front of the new mixing bar with a piece of gauze dipped in ethanol.
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d) When installing the new mixing bar, insert the mixing bar at the heel of the motor and fix it with M2 screws as
shown in the figure:
Fig. 10-4-24
e) Put the adjusting block of the mixing bar on the bracket of the cuvette and move the cuvette above the adjusting
block as shown in the figure:
Stirring mechanism
Height adjusting
screw
Put the adjusting block

here
Cuvette
bracket
Adjusting block
Fig. 10-4-25
f) Screw off M2 screw, and adjust the mixing bar until its point touches the upper surface of adjusting block as
shown in the figure: fasten M2 screw.
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Mixing bar
Upper end of
adjusting block
Cuvette bracket
Fig. 10-4-26
g) Select "Mixing mechanism check" from "Mechanism check" of the "System maintenance" window, and click
" " and " " to confirm whether the position of mixing bar is correct, if
not, please contact the customer service.
h) Execute "Mechanical action check" for 10 times in "Mechanism check" of the "System maintenance" window
and confirm whether or not the mechanical action is normal.
10.4.6 Cleaning refrigeration chamber
As the refrigeration chamber may be polluted by sample, reagent or dust, cleaning shall be executed once a month.
(1)Take out the sample disk, and wipe the part inside the refrigeration chamber with gauze:
Fig. 10-4-27
(2)Wipe the reader window of barcode reader with lens paper, as shown in the figure:
Fig. 10-4-28
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As laser barcode reader is adopted for the Analyzer, do not directly look at the reader window of barcode
reader under non-shutdown status.
10.4.7 Syringe pump
(1) Syringe pump includes detergent syringe pump and dispensing syringe pump, and also ISE dilution syringe pump
if it is connected with ISE device. Syringe pump can be generally used for about 1 million times, and needs to be
replaced after the 15 months of using. Please contact consumer-service staff for replacement.
(2) Check the syringe pump observation in front of the Analyzer and whether the dispensing syringe pump has
bubbles, if so, conduct exhausting and maintenance according to 10.2.3, as shown in the figure:
Sample dispensing
Rinsing syringe syringe pump
pump
ISE dilution
syringe pump
Observation window
of syringe pump
Fig. 10-4-29
Use pure water to clean surface of syringe pump instead of alcohol or other organic solution.
10.4.8 Maintenance of the Analyzer before stop
Take the following measures to maintain the Analyzer before maintenance or treatment:
(1) Take out all reagent bottles, and sample tubes and standard cups containing sample, calibrator and QC solution
from the sample reagent disk.
(2) Remove the tubing and cables connected with the pure water tank and the waste liquid tank by the method
detailed in "10.4.11 Cleaning of tanks and filters".
(3) Completely exhaust the liquid in the syringe pump and other tubes.
(4)Push directly during a stable transport in short distance.
(5) Keep the Analyzer vertical during carrying and transport process.
(6) Avoid vibration during carrying, and check and adjust the Analyzer after carrying to make sure it is normal
before use.
10.4.9 Cleaning and maintenance of the Analyzer
Clean the surface of analyzer regularly to keep it tidy. Wipe the surface with a wet and soft cloth or gauze, or those
dipped in pure water of small amount if necessary. But don't wipe it with any organic solvent in case of damages to
the shell.
The operator shall pay attention to the following matters during cleaning:
(1) Take proper disinfection measures in case of hazardous substance leaked on the surface or inside the equipment.
(Carry out disinfection through wiping with 84 disinfectant that is diluted with the ratio of 1:200).
(2) Don't use the detergent or sanitizer with possibility of danger due to chemical reaction with parts or materials in
equipment.
(3) In case of doubts about the compatibility between sanitizer or detergent and parts or materials in equipment,
please consult the manufacturer or its agencies.
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10.4.10 Waste liquid treatment

Two kinds of waste liquid will be produced during the normal operation of the Analyzer:
(1) High-concentration waste liquid: generated during the test, and the waste liquid contains serum and various
biochemistry reagent.
(2) Low-concentration waste liquid: composed of pure water for rinsing the cuvette of the Analyzer, that for rinsing
all probe mechanism, overflowing water and condensate water.
According to the national laws and regulations, the waste liquid shall be discharged only after disinfection, and the
waste liquid generated from the Analyzer shall be disposed as per the following principles:
(1) High-concentration waste liquid: drain the waste liquid after mixing with "84 disinfectant" as the proportion of 1:
50.
(2) Low-concentration waste liquid: it can be directly discharged only if the PH concentration is in compliance with
the Level-one standard of maximum discharging concentration.
● Please handle the waste fluid of the Analyzer to prevent potential biological and chemical pollution.
● High-concentration waste liquid cannot be discharged after mixing with low-concentration waste liquid.
10.4.11 Cleaning of pure water tank and filter
In case of operation duration of the Analyzer over 1 month under normal status, the pure water tank may have
impurities which will affect the measurement accuracy and instrument stability, so the regular cleaning shall be
conducted to the pure water tank and the filter:
1
1
3 2
Fig. 10-4-30
(1) Take out pure water float switch from the pure water tank (No. 3 of Fig. 10-4-30), remove the inlet tube (No. 2 of
Fig. 10-4-30) and put it at a clean position, then separate Tube 2 from Part 6, and push out the Part 6 from the
mounting part 6 with a swab, next wash the Part 9 with tap water at its front and back faces, and finally reinstall the
part.
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(2) Rinse the pure water tank with clean water at least for 3 times till there are no visible impurities on the inner wall.
(3)Assemble the parts of the pure water tank and connect it with the Analyzer correctly.
(4)Enter the "Exhaust" window under the "System Maintenance" interface, select "Not suck detergent", click the "
" button to carry out syringe pump exhaust to avoid bubbles in the tubing.
10.4.12 Replacement of thermostatic degassing system
(1) Turn off the power on the lower right of the analyzer, remove the rear cover plate of the analyzer, and disconnect
the XR78-80 tube (Tube 2) between V1 solenoid valve and the thermostatic degassing system.
(2) After 1min, disconnect the XR78-500 inlet tube (Tube 1) and the XR78-200 degassing tube (Tube 28) at the
bottom of the thermostatic degassing tank; disconnect the three wire plugs on the thermostatic degassing tank, as the
figure shows:
XR78-80(Tube 2)
Wire plug
Fig. 10-4-31
Fig. 10-4-32
(3) Loosen the two fixing screws of the thermostatic temperature degassing tank, take the thermostatic temperature
degassing tank out of the analyzer, and place it on a clean table.
(4) Replace the new thermostatic degassing tank in its original position, and connect the tubing and the wire plug one
by one to ensure accuracy.
Note:
● When replacing the thermostatic degassing tank, remove Tube No.1, No.2, No.28 tubes, and wire
plugs and then replace the components.
● During the replacement process, there will be overflow at the outlet of Tube No. 1. Prepare a water
holding device or use a nylon tie, plug, etc. to seal before removing the tube.
(5) Turn on the power switch on the lower right side of the Analyzer. During the power-on reset of the Analyzer,
the rinsing probe dispensation detection will be performed. After replacing the degassing tank, the tubing
becomes empty and the water in the tubing cannot be supplemented in time, thus the instrument will stop due
to the alarm "3-11-2 rinsing mechanism’s rinsing probe water dispensation is abnormal". After multiple resets,
the tubing is filled with water, and it enters standby mode. If the alarm still occurs after
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multiple resets, check the tubing.
The probe rinsing bath may have water spray when air bubbles are present in the tubing, and it
should be promptly cleaned.
(6) Execute the "syringe pump air exhausting" operation to ensure no air bubbles in the sample syringe pump
(500 μL) or the water supply syringe pump (10 mL).
10.5 Scrapped analyzer
Do not abandon the Analyzer randomly after its service life but inform of the manufacturer for recycle.
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Chapter 11 Alarm and Treatment of the Analyzer
11.1 Type of alarm message

The alarm message is divided into data alarm and fault alarm as per different contents. The data alarm is classified as
per its caution level, and can be divided into caution alarm, sample-stopping alarm and stop alarm. In case of
different types of alarm, the Analyzer will act as per Table 11-1:
Table 11-1 Actions of the Analyzer after Alarm
Type of alarm message Actions of the Analyzer

The objects of alarm are the tested results (caution level). The Analyzer will continue the
Data alarm
analyzing test.
It occurs both during data alarm and fault alarm. But the operation will continue as usual. The
Caution level alarm
operator shall decide whether to continue the analysis or not as per specific conditions.
Sample-stopping level The objects of alarm are the faults of the Analyzer. The adding process of new samples is
alarm stopped. The analyzing process of the samples added into the cuvette shall be continued.
The objects of alarm are the faults of the Analyzer. The Analyzer stops working immediately.
Stop level alarm
The test results are untrustworthy.
11.2 Solutions for faults without alarm

11.2.1 Abnormality of data without alarm
Some problems of the test data may not lead to an alarm, however, those abnormal conditions can be discovered by
measuring the QC solution, and rechecking and observing the state of the Analyzer.
The data faults and solutions without alarms are shown in Table 11-2-1:
Table 11-2-1 Data Faults and Solutions without Alarms
Fault
Main causes Solutions
example
1. Maintain the Analyzer regularly as per the User
1. The Analyzer is not maintained correctly and
Manual.
regularly.
2. Replace reagent, and save and use the reagent
2. The reagent goes bad with insoluble matter
correctly.
dissolved or mixed with impurities.
3. Keep the conductivity of pure water used below
3. The quality of pure water is poor.
1μs/cm.
4. CXL Pro anti-bacterial phosphor-free
4. Add detergent and conduct cuvette rinsing program in
detergent and CXL Pro alkaline detergent are
Poor system maintenance.
insufficient and incompletely rinsed.
repeatability 5. Use special reagents of AGAPPE Biochemical
5. The reagent crystallizes in the cold bin (poor
Analyzer.
low value reproducibility).
6. Place the reagents possibly with cross contamination
6. There are cross contaminations among
at intervals or use a cross contamination procedure for
analysis items.
avoiding.
7. Conduct separated pretreatment for unacceptable
7. Sample is acceptable as it has fibrous protein.
samples or recollect samples.
8. There is dirt or liquid on the surface of probe
8. Wipe the surface of probe with a cotton swab dipped
with alcohol
1. The standard solution is concentrated or 1. The standard solution shall be used once after being
Poor ineffective. added into the standard cup and saved well.
accuracy 2. The formula of reagent is not correct. 2. Replace the reagent.
3. The conditions for analysis are poor. 3. Set the parameters correctly.
The above conditions are only examples, and the data abnormities during test shall be analyzed as per the
specific causes.
11-1
User Manual
11.2.2 Faults of the Analyzer without alarm

The Analyzer fault and solutions without alarms are shown in Table 11-2-2:
Table 11-2-2 Analyzer Fault and Solutions without Alarms
Fault message Main causes Solutions

1. Probe tip is dirty.
After rinse, probe
2. Air leakage is found at tubing or filling 1. Wipe the probe with swab dipped in alcohol.
outer wall has water
injector of the sample dispensing 2. Conduct maintenance and inspection.
drops
mechanism.
1. Add detergent.
1. Alkaline detergent used to rinse the
2. Check the connecting part.
Water drops from cuvette is used up.
3. Conduct maintenance of the rinsing
rinsing mechanism 2. Air leaks at tubes of rinsing mechanism.
mechanism, please contact the customer service if
3. Nozzle and tubes are blocked.
to replace the hose.
Conduct maintenance of the rinsing mechanism,
No water flows from
Nozzle and tubes are blocked. please contact the customer service if to replace
the rinsing nozzle
the hose.
No water flows from Rinse the discharge outlet, please contact the
Discharge outlet and tubes are blocked.
the rinsing bath customer service if to replace the hose.
Thermostatic water
filled in the cuvette Conduct maintenance of the rinsing mechanism,
by rinsing Nozzle and tubes are blocked. please contact the customer service if to replace
mechanism the hose.
overflows
Water leaks at
dispensing The interface is installed incorrectly. Reinstall it after confirming there are water leaks.
mechanism
1. Reinstall the equipment after confirming that
the air is in.
There are bubbles in 1. The interface is installed incorrectly. 2. Execute exhaust process in the system; if the
the dispensing 2. Air in filling charger is insufficiently micro bubbles cannot be removed, knock the
mechanism exhausted. syringe pump slightly when the reagent or
detergent are flowing to eliminate the bubbles by
making use of vibration.
11-2
User Manual
11.3 Alarm message and solutions

Alarm
Alarm
Warning Brief description Specific description Reference solutions
code
Grade
When calibrating
When calibrating standard
standard solution 1, Confirm whether the standard
0-2 Warning solution 1, exceeded the
exceeded the allowable solution and reagent are normal.
allowable absorbance
absorbance
Difference between K factor (1)Confirm if K factor is correct.
calibrated last time and K factor (2)Confirm if standard solution
K factor inspection
0-4 Warning obtained in current calibration deteriorates.
beyond the range
exceeds 20% of the average of (3)Confirm if the reagent
last value and current value. deteriorates.
Concentration beyond The test result exceeds the (1) Measure after diluting the sample.
0-5 Warning linearity range linearity range of the item. (2) Confirm the linear range set value.
(1) Check whether there is foreign
The calculated difference value matter in the sample.
Linear abnormality between light measuring points (2) Check whether there is foreign
0-6 Warning
found in the specified light measuring matter and bubble in the reagent.
range exceeds the linear limit. (3)Test after diluting the sample.
(4)Check the mixing mechanism.
(1)Confirm whether the set value of
In calibration of linear (point sensitivity test is correct.
2-6) and nonlinear items, the (2)Confirm whether the reagent
difference value between the deteriorates.
Abnormity in
0-7 Warning average absorbance of (3) Confirm whether the input
sensitivity inspection
calibrator 1 and calibrator N is concentration value of standard
lower than the sensitivity limit solution is correct.
(input value). (4) Confirm whether the calibration
solution has gone bad.
(1)Measure after diluting the sample.
During the antigen re-addition (2)Confirm whether the preparation
Prozone test beyond method and reaction rate ratio and placement position of reagent are
0-8 Warning
the range method, the prozone test value correct.
exceeds the set limit. (3)Confirm whether the set value of
prozone test is correct.
(1)Measure after diluting the sample.
In rate A method or 2-point rate (2)Confirm whether the preparation
Reaction boundary
method, the absorbance and placement position of reagent are
0-9 Warning absorbance beyond the
boundary check value exceeds correct.
range
the set value. (3)Confirm whether the set value of
absorbance boundary is correct.
(1) Confirm whether the formula is
rational.
(1)The denominator is 0 during
(2) Check whether the setting of
the calculation.
concentration of calibration solution
(2)Superthreshold in Log or
during multi-point calibration is
Exp calculation.
0-10 Warning Unable to calculate correct.
(3)The calculated absorbance of
(3) Check the absorbance value of
the test item is smaller than the
light measuring point of the test item.
absorbance of calibration
(4)Check whether reagents and
solution 1 of the item.
samples are sufficient and whether
the position is correct.
(1)Please check whether the position
of calibration solution is correct.
The absorbance of calibrator
(2)Please check whether the
does not increase with the
0-11 Warning Unable to calculate absorbance of calibration solution of
increase of concentration
different concentrations increases
during all-point calibration.
progressively.
(3)Please calibrate again.
Please check whether ISE reagent
The denominator is 0 during the
0-12 Warning ISE calculation failed and sample are sufficient and
calculation.
whether the position is correct.
11-3
User Manual
Alarm
Alarm
code Grade
Item timeout The timeout time in item
calibration time up, calibration parameter setting is
0-13 Warning
please perform the up, please perform the
calibration calibration.
The concentrated Please execute concentrated waste
The concentrated waste fluid
0-14 Warning waste fluid pipeline fluid pipeline rinsing in system
pipeline needs to be rinsed.
needs to be rinsed maintenance window.
0-15 Warning Unable to calculate The test item is not calibrated. Please calibrate the item first.
During the calibration of
(1) Confirm whether the set value of
nonlinear standard curve and
calibration item offset degree is
linearity (multi-point), the
correct.
difference of absorbance at
Offset degree check (2) Confirm whether the reagent
0-16 Warning different concentrations got
beyond the range deteriorates.
with the fitting formula and
(3) Confirm whether the input
measured absorbance is greater
concentration value of standard
than the allowable deviation of
solution is correct.
absorbance.
ISE calibration should be
Please execute ISE executed as ISE maintenance
0-17 Warning Please execute ISE calibration.
calibration (ISE matching cuvette rinsing)
is executed.
Calibration test cannot be
completed as the sample
Failure to complete cuvette of standard solution is Please send for calibration again in
0-18 Warning
calibration test not placed or the sample standby mode after check.
volume in standard solution
sample cuvette is insufficient.
Quality control test cannot be
completed as the sample
cuvette of quality control
Failure to complete Please send for quality control again
0-19 Warning solution is not placed or the
quality control test in standby mode after check.
sample volume in quality
control solution sample cuvette
is insufficient.
The reagent bar code is found (1) Please check the bar code pasting
Sample and reagent
to have been used when the bar information.
0-20 Warning disk reagent bar code
code is registered at sample and (2) Rescan the reagent bar code after
has been used
reagent disk. the check.
(1) Please check the bar code pasting
Reagent type R2 or R3 Reagent type R1 or R2 found in information.
0-21 Warning
found in R1 disk sample and reagent disk (2) Rescan the reagent bar code after
the check.
(1) Bar code is voided when
reagent residual volume is less (1) Please check the bar code pasting
Sample and reagent
than the set reagent residual information.
0-23 Warning disk bar code has been
volume. (2) Rescan the reagent bar code after
voided
(2) Reuse the bar code after it is the check.
voided.
(1) Verification of bar code
failed
information.
(2) Bar code reagent name not
Sample and reagent (2) Rescan the reagent bar code after
0-24 Warning added in "bar code item
disk bar code is void. the check.
settings"
(3) Add corresponding items in bar
(3) Bar code reagent type
code item settings.
verification error
Sample and reagent
R2 disk reagent bar code has information.
0-25 Warning disk reagent bar code
been used (2) Rescan the reagent bar code after
has been used.
the check.
Reagent of type R1 or
Reagent of type R1 or R2 found information.
0-26 Warning R2 found in sample
in sample and reagent disk (2) Rescan the reagent bar code after
and reagent disk
the check.
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User Manual
Alarm
Alarm
code Grade
(1) Bar code is voided when
reagent residual volume is less (1) Please check the bar code pasting
Sample and reagent
than the set reagent residual information.
0-28 Warning disk bar code has been
volume. (2) Rescan the reagent bar code after
voided
(2) Reuse the bar code after it is the check.
voided.
(1) Verification of bar code
failed
(2) Bar code reagent name not
Sample and reagent information.
0-29 Warning added in "bar code item
disk bar code is void. (2) Rescan the reagent bar code after
settings"
the check.
(3) Bar code reagent type
verification error
(1) Call out reagent information form
and confirm whether there is reagent
Insufficient residual The residual volume of reagent
below the set value of residual
0-40 Warning reagent at sample and is lower than the set value on
reagent volume.
reagent disk system setting interface.
(2) Confirm if the set value of reagent
residual volume is reasonably set.
(1) Call out reagent information form
and confirm whether there is reagent
Insufficient residual The residual volume of reagent
below the set value of residual
0-41 Warning reagent at sample and is lower than the set value on
reagent volume.
reagent disk system setting interface.
(2) Confirm if the set value of reagent
Residual volume of R1 (1)Call out reagent information
Residual volume of
anti-bacterial window and confirm if the
0-42 Warning anti-bacterial phosphor-free
phosphor-free anti-bacterial phosphor-free detergent
detergent is less than 5mL.
detergent is low is sufficient.
Residual volume of R2 (1)Call out reagent information
Residual volume of
anti-bacterial window and confirm if the
0-44 Warning anti-bacterial phosphor-free
phosphor-free anti-bacterial phosphor-free detergent
detergent is less than 5mL.
detergent is low is sufficient.
Sample and reagent
Volume of R1 reagent in
disk reagent Please check if the analysis
0-46 Warning analysis parameters is less than
information setting parameters are correctly set.
or equal to 0.
error
Sample and reagent
Volume of R2 reagent in
disk reagent Please check if the analysis
0-47 Warning analysis parameters is less than
information setting parameters are correctly set.
or equal to 0.
error
During automatic recheck,
Invalid setting of Please check if the setting of sample
sample size parameter for
sample volume size parameter for recheck item
0-48 Warning recheck item meeting certain
parameter for meets automatic recheck
requirement is not set or is
automatic recheck requirements.
invalidly set.
(1) Please check whether the bar code
No sample to be tested No sample to be tested found is correctly pasted.
0-58 Warning
found from LIS port from LIS port. (2) Please check whether there is
sample information in LIS system.
rational.
(2) Check the absorbance value of
Overflow of calculated Overflow of calculated result in
0-60 Warning light measuring points of test item.
result correlation formula.
(3)Check whether reagents and
Expression in The calculation formula or
calculation formula or compensation formula is an (1)Confirm whether the calculation
0-61 Warning
compensation formula illegal mathematical formula is correct.
has error. expression.
11-5
User Manual
Alarm
Alarm
code Grade
(1) Please confirm whether the
The test result in calculation decimal separator in the current
Abnormal item test
formula or compensation operating system is consistent with
results in calculation
0-62 Warning formula fails to be translated the decimal separator used by
formula or
into effective floating-point software.
compensation formula
number. (2) Confirm whether the formula is
correct.
rational.
No test results of item
There are items without test (2) Check the absorbance value of
in calculation formula
0-63 Warning results in calculation formula or light measuring points of test item.
or compensation
compensation formula. (3)Check whether reagents and
formula
Absent test item in There are absent test items in
(1)Confirm whether the formula is
0-64 Warning calculation formula or calculation formula or
rational.
compensation formula compensation formula.
Please execute the
The number of tested items has
operation of sample Please execute the operation of
0-70 Warning exceeded the number of setup
probe rinsing in sample probe rinsing
items of sample probe rinsing.
standby mode
(1)Confirm whether the cooling fan
of instrument rotates normally.
Water temperature in Water temperature in (2)Confirm whether the dust cover of
incubation bath is incubation bath is higher than cooling fan of refrigeration system is
0-71 Warning
blocked by dust.
higher than 45℃ 45℃.
(3)If unable to revert to normal,
please contact with the maintenance
personnel in time.
(1) Confirm whether the room
temperature is in the range of
15-32℃.
(2) Confirm whether the cooling fan
Water temperature in of instrument rotates normally.
Water temperature in (3)Confirm whether the dust cover of
incubation bath is
0-72 Warning incubation bath is beyond the cooling fan of refrigeration system is
beyond the range
range (37±0.5) ℃. blocked by dust.
(37±0.5) ℃
(4) Confirm whether water in
incubation bath circulates.
(5) If unable to revert to normal,
please contact with the maintenance
personnel in time.
The residual alkaline detergent Please recharge the reagent through
Alkaline detergent
0-81 Warning used for recharging is 0, please the Reagent recharging in System
needs recharging
recharge. setting.
Anti-bacterial The residual anti-bacterial
Please recharge the reagent through
phosphor-free phosphor-free detergent used
0-82 Warning the Reagent recharging in System
detergent needs for recharging is 0, please
setting.
recharging recharge.
The potential of reference
ISE-Na+LEVEL out of
0-85 Warning solution measuring point is out
the range
of range.
ISE-K+LEVEL out of
the range
of range.
ISE-Cl-LEVEL out of
the range
of range.
ISE-Ca+LEVEL out of
the range
of range.
11-6
User Manual
Alarm
Alarm
code Grade
(1) Confirm whether the calculation is
reasonable.
(1) During calculation, the
(2) Check whether the calibrator
denominator is 0.
concentration setting is correct in
(2) When calculating Log or
multi-point calibration.
Exp, above-threshold occurred.
0-90 Warning Cannot calculate (3) Check the absorbance value of the
(3)The calculation absorbance
calculation metering point of the test
of the test item is less than
item.
calibrator 1 absorbance of the
(4) Check whether the reagent,
item.
sample are enough; whether the
position is correct.
(1)Call out the system maintenance
window, and execute "ISE check".
(1)The SLOPE of calibration (2)If it is determined that it is not a
0-91 Warning ISE SLOPE exception result is in the following range. single fault, please contact with the
Na: SLOPE＜35mV. maintenance personnel.
(3)Please conduct ISE calibration
again.
K: SLOPE＜25mV. maintenance personnel.
again.
Cl: SLOPE＞-25mV. maintenance personnel.
again.
Ca: SLOPE＞-25mV maintenance personnel.
again.
(1)The reference solution window, and execute "ISE check".
ISE reference solution concentration (C(IS)) is in the (2)If it is determined that it is not a
0-95 Warning concentration following range. Na: C(IS)＜ single fault, please contact with the
exception 150.0mmol/l or 300.0mmol/l＜ maintenance personnel.
C(IS) (3)Please conduct ISE calibration
again.
(1)The reference solution
ISE reference solution (2)If it is determined that it is not a
concentration (C(IS)) is in the
0-96 Warning concentration single fault, please contact with the
following range. K:C (IS) <
exception maintenance personnel.
4mmol/l or 10mmol/l < C (IS)
again.
0-97 Warning concentration following range. Cl:C (IS) < single fault, please contact with the
exception 100mmol/l or 200mmol/l < C maintenance personnel.
(IS) (3)Please conduct ISE calibration
again.
11-7
User Manual
Alarm
Alarm
code Grade
0-98 Warning concentration following range. Ca:C (IS) < single fault, please contact with the
exception 80mmol/l or 120mmol/l < maintenance personnel.
C(IS) (3)Please conduct ISE calibration
again.
Please check whether the sample and
ISE is beyond the ISE quality control solution is
reagent volume of quality control
0-101 Warning lower limit of beyond the lower limit of
solution is sufficient and whether the
measuring range measuring range
ISE is beyond the ISE quality control solution is
reagent volume of quality control
0-102 Warning upper limit of beyond the upper limit of
solution is sufficient and whether the
measuring range measuring range
ISE reference solution The residual ISE reference Please recharge the reagent through
0-103 Warning reagent needs to be solution used for recharging is the Reagent recharging in System
recharged 0, please recharge. setting.
The residual ISE diluent used Please recharge the reagent through
ISE diluent reagent
0-104 Warning for recharging is 0, please the Reagent recharging in System
needs to be recharged
recharge. setting.
(1)Confirm if there is reagent with
Residual volume of The residual volume of reagent residual volume less than the set
0-105 Warning ISE reference solution is lower than the set value on value of reagent residual volume.
reagent is insufficient. system setting interface. (2)Confirm if the set value of reagent
(1) Confirm if there is reagent with
Residual volume of The residual volume of reagent residual volume less than the set
0-106 Warning ISE dilution reagent is is lower than the set value on value of reagent residual volume.
insufficient system setting interface. (2) Confirm if the set value of reagent
ISE compensation
ISE compensation value reagent volume of standard solution
0-107 Warning value exceeds the
exceeds the measuring range. is sufficient and whether the position
measuring range
is correct.
ISE slope value exceeds the Please check whether the sample and
ISE slope value
measuring range, calibration reagent volume of standard solution
0-108 Warning exceeds the measuring
fails, and calibration result is is sufficient and whether the position
range
not updated. is correct.
ISE internal standard The residual ISE internal Please recharge the reagent through
0-109 Warning solution reagent needs solution used for recharging is the Reagent recharging in System
to be recharged 0, please recharge. setting.
(1) Confirm if there is reagent with
Residual volume of
The residual volume of reagent residual volume less than the set
ISE internal standard
0-110 Warning is lower than the set value on value of reagent residual volume.
solution reagent is
system setting interface. (2) Confirm if the set value of reagent
insufficient.
(1) Please check whether network
LIS server connection is normal.
0-149 Warning LIS server communication fault
communication fault (2) Please check whether LIS server
works normally.
Abnormal measured Check the absorbance in test (1)Please contact maintenance
0-150 Warning absorbance process personnel.
Receiving data timeout caused
(1)Please contact maintenance
0-250 Warning Receiving data timeout by reception of error data
personnel.
header
Sending or receiving data failed (1) Please check if network
Network card is
because network card is connection is normal.
0-251 Warning prohibited or network
prohibited or network cable is (2) Please check if the network card
cable is pulled out
pulled out works normally
11-8
User Manual
Alarm
Alarm
code Grade
(1)Please check if network
connection is normal.
personnel.
(3)Error code meaning:
10050-a dead network encountered
for socket operation
Instrument data Sending or receiving data failed 10053-an established connection was
0-252 Warning sending or receiving due to because network fails or abandoned by the software of your
failed sever is stopped. host.
10054-an existing connection was
forcibly closed by the remote host.
10055-an operation on a socket could
not be performed because the system
lacked sufficient buffer space or
because a queue was full.
10064-?
Receiving confirmation
Sending data to (2) Please check if the instrument
0-253 Warning command not received from the
instrument timeout works normally
instrument in set time interval
(3) Please contact maintenance
personnel.
Status data not received from
Receiving instrument (2) Please check if the instrument
0-254 Warning the instrument in set time
state data timeout works normally
interval
personnel.
Communication Communication data not
(2) Please check if the instrument
0-255 Warning connection fault with received from the instrument in
works normally
instrument set time interval
personnel.
(1) Call out system maintenance
Temperature in incubation bath window, and execute "reset".
Incubation bath
1-1-1 Stop does not reach constant 37°C in (2) If unable to revert to normal, or
pre-heating timeout
regulated time during resetting. other errors occur, please contact
maintenance personnel in time.
can heartbeat response timeout window, and execute "reset".
Abnormal can bus of
1-1-2 Stop of reaction disk control board (2) If unable to revert to normal, or
reaction disk
and abnormal can bus other errors occur, please contact
Abnormal can bus of
1-1-3 Stop of probe control board and (2) If unable to revert to normal, or
probe
abnormal can bus other errors occur, please contact
Abnormal can bus of
1-1-4 Stop of AC control board and (2) If unable to revert to normal, or
AC board
abnormal can bus other errors occur, please contact
window, execute "reset" and send
Data receiving of data Data has not been received
test again
1-1-6 Stop collection board from data collection board in 20
(2) If unable to revert to normal, or
timeout seconds during test
other errors occur, please contact
11-9
User Manual
Alarm
Alarm
code Grade
(1)After having dispensed samples
tested, call out system maintenance
The Finish command is not window, execute "reset" and send
Sampling Sample dispensing of
1-1-7 replied in regulated time after test again under standby mode.
Stop probe timeout
probe dispenses sample. (2)If unable to revert to normal, or
Sampling R1 dispensing of probe
Stop timeout
probe dispenses R1. (2)If unable to revert to normal, or
Sampling R2 dispensing of probe
Stop timeout
probe dispenses R2. (2)If unable to revert to normal, or
Sampling ISE dispensing of
Stop probe timeout
probe dispenses ISE. (2)If unable to revert to normal, or
Abnormal window, and execute "reset".
No response of data collection
1-1-13 Stop communication of data (2) If unable to revert to normal, or
board during resetting
collection board other errors occur, please contact
Communication and data window, and execute "reset".
Communication and
1-1-15 Stop collection is not finished in (2) If unable to revert to normal, or
data collection timeout
regulated time other errors occur, please contact
Execute probe maintenance (1) Call out system maintenance
Probe maintenance
action: no maintenance window, and execute "reset".
action: vertical
1-1-16 Stop completion command received (2) If unable to revert to normal, or
inspection of reaction
when it comes to vertical other errors occur, please contact
disk timeout
inspection of reaction disk maintenance personnel in time.
Probe maintenance
action: no maintenance window, and execute "reset".
action: vertical
1-1-17 Stop completion command received (2) If unable to revert to normal, or
inspection of reagent
when it comes to vertical other errors occur, please contact
disk timeout
inspection of reagent disk maintenance personnel in time.
Maintenance action: action: no maintenance window, and execute "reset".
1-1-18 Stop horizontal inspection completion command received (2) If unable to revert to normal, or
of probe timeout when it comes to horizontal other errors occur, please contact
inspection of probe maintenance personnel in time.
No maintenance completion
Maintenance action: window, and execute "reset".
command received when
1-1-19 Stop syringe pump air (2) If unable to revert to normal, or
executing air exhausting action
exhausting timeout other errors occur, please contact
of syringe pump
1-1-20 Stop rinsing mechanism (2) If unable to revert to normal, or
executing inspection action of
inspection timeout other errors occur, please contact
rinsing mechanism
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User Manual
Alarm
Alarm
code Grade
1-1-21 Stop mixing mechanism (2) If unable to revert to normal, or
executing inspection action of
inspection timeout other errors occur, please contact
rinsing mechanism
Residual reagent Residual reagent volume
window, and execute "reset".
volume scanning scanning not finished in
1-1-22 Stop (2) If unable to revert to normal, or
timeout under standby regulated time under standby
mode mode
Bar code scanning Bar code scanning not finished window, and execute "reset".
1-1-23 Stop timeout under standby in regulated time under standby (2) If unable to revert to normal, or
mode mode other errors occur, please contact
Execute maintenance action: no (1) Call out system maintenance
maintenance completion window, and execute "reset".
Maintenance action:
1-1-24 Stop command received in regulated (2) If unable to revert to normal, or
water drainage timeout
time during water drainage of other errors occur, please contact
machine maintenance personnel in time.
Maintenance action: maintenance completion window, and execute "reset".
1-1-25 Stop bar code position command received in regulated (2) If unable to revert to normal, or
inspection timeout time during bar code position other errors occur, please contact
inspection maintenance personnel in time.
Execute maintenance action: no
Maintenance action: maintenance completion
1-1-26 Stop (2) If unable to revert to normal, or
ISE inspection timeout command received in regulated
time during ISE inspection
1-1-27 Stop ISE internal standard command received in regulated (2) If unable to revert to normal, or
tubing rinsing timeout time during ISE internal other errors occur, please contact
standard tubing rinsing maintenance personnel in time.
1-1-28 Stop ISE reference tubing command received in regulated (2) If unable to revert to normal, or
rinsing timeout time during ISE reference other errors occur, please contact
tubing rinsing maintenance personnel in time.
1-1-29 Stop ISE dilution tubing command received in regulated (2) If unable to revert to normal, or
rinsing timeout time during ISE dilution tubing other errors occur, please contact
rinsing maintenance personnel in time.
1-1-30 Stop ISE all tubing rinsing command received in regulated (2) If unable to revert to normal, or
timeout time during ISE all tubing other errors occur, please contact
1-1-31 Stop ISE dilution pump air command received in regulated (2) If unable to revert to normal, or
exhausting timeout time during ISE dilution pump other errors occur, please contact
air exhausting maintenance personnel in time.
1-1-32 Stop ISE flow cell rinsing command received in regulated (2) If unable to revert to normal, or
timeout time during ISE flow cell other errors occur, please contact
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User Manual
Alarm
Alarm
code Grade
1-1-33 Stop ISE proportioning cup command received in regulated (2) If unable to revert to normal, or
rinsing timeout time during ISE proportioning other errors occur, please contact
cup rinsing maintenance personnel in time.
(1)Click Suspend dispensing and
after the dispensing stops, replace
Skip all tests of the sample if
with new sample and conduct test
1-1-34 Warning Sample skip the sample volume is
(2)If unable to revert to normal, or
insufficient.
(1) Click Suspend dispensing and
after the dispensing stops, dispense
Skip all tests with this reagent if
reagent and conduct test
1-1-35 Warning R1 reagent skip the R1 reagent volume is
insufficient.
Skip all tests with this reagent if
1-1-36 Warning R2 reagent skip the R2 reagent volume is
insufficient.
(1) Click Maintenance to rinse the
cuvette and then conduct the test
Sampling Cuvettes stained 5 continuously stained cuvettes again
1-1-37
Stop continuously in test (2) If unable to revert to normal, or
(1) Click Maintenance to rinse the
cuvette and then conduct the test
Cuvette blank value exceeds the again
1-1-38 Warning Cuvettes stained
set upper and lower limit in test (2) If unable to revert to normal, or
(1)Try to have resetting again.
Reaction disk resetting failed
Reaction disk control (2)If unable to revert to normal, or
1-1-39 Stop when executing resetting action
board resetting failed other errors occur, please contact
of the machine
Probe resetting failed when
Probe control board (2)If unable to revert to normal, or
1-1-40 Stop executing resetting action of the
resetting failed other errors occur, please contact
machine
AC control board resetting
AC control board (2)If unable to revert to normal, or
1-1-41 Stop failed when executing resetting
action of the machine
ISE resetting failed when
ISE control board (2)If unable to revert to normal, or
1-1-42 Stop executing resetting action of the
machine
(1) Execute communication and data
Little white block rinsing failed collection
Little white block
1-1-43 Stop after executing resetting action (2) If unable to revert to normal, or
rinsing failed
of the machine other errors occur, please contact
Residual reagent volume in R1
1-1-44 Warning Reagent is used up or R2 bottle is less than
minimum residual volume
11-12
User Manual
Alarm
Alarm
code Grade
(1)Try to conduct resetting and
Waiting for sample
Under the sample dispensing sending test again and click Continue
dispensing timeout
suspension state, sample sample dispensing in regulated time
1-1-45 Stop under sample
dispensing is not continued in (2)If unable to revert to normal, or
dispensing suspension
regulated time other errors occur, please contact
state
The cuvette blank of the cuvette window, and execute "reset".
Basic value gaining
1-1-46 Stop for first test exceeds the range (2) If unable to revert to normal, or
failed
8000-18000 other errors occur, please contact
Membrane or bubbles are found window, and execute "reset".
1-1-47 Warning Probe detects bubbles at bottle mouth when the probe (2) If unable to revert to normal, or
aspirates sample or reagent other errors occur, please contact
The probe fails to descend more (1) Call out system maintenance
Liquid surface
as the liquid detection signal is window, and execute "reset".
detection failure. The
1-1-48 Warning disturbed above the bottle (2) If unable to revert to normal, or
probe fails to descend
mouth when the probe aspirates other errors occur, please contact
more.
sample or reagent maintenance personnel in time.
1-1-49 Stop water quality command received in regulated (2) If unable to revert to normal, or
inspection timeout time during ISE all tubing other errors occur, please contact
Maintenance action: action: no maintenance window, and execute "reset".
1-1-50 Stop vertical inspection of completion command received (2) If unable to revert to normal, or
probe timeout when it comes to vertical other errors occur, please contact
inspection of probe maintenance personnel in time.
window, execute "reset" and conduct
Reaction disk
Reaction disk received is not test again
1-1-51 Warning triggering sequence
the first one triggered 10 start (2) If unable to revert to normal, or
error
Reaction disk
the first one triggered 10 stop (2) If unable to revert to normal, or
error
Reaction disk
the one triggered 30 start (2) If unable to revert to normal, or
error
Reaction disk
the one triggered 30 stop (2) If unable to revert to normal, or
error
Reaction disk Reaction disk received is not
test again
1-1-55 Warning triggering sequence the second one triggered 10
error start
11-13
User Manual
Alarm
Alarm
code Grade
Reaction disk Reaction disk received is not
test again
1-1-56 Warning triggering sequence the second one triggered 10
error start
Reaction disk
the one triggered 35 start (2) If unable to revert to normal, or
error
Reaction disk
the one triggered 35 stop (2) If unable to revert to normal, or
error
(1) Click disconnect, connect again,
Test software Disconnect is not clicked on the and check whether there is an alarm.
1-1-59 Stop disconnected test software, but the network is (2) Please contact the maintenance
abnormally disconnected abnormally personnel if it cannot return to
normality or other failure occurs.
(1) Go to the system maintenance
window, execute "Reset", and test
Water quality check When checking water quality, again.
1-1-60 Stop
failure the structure is abnormal (2) Please contact the maintenance
personnel if it cannot return to
Sampling Reagent sample disk During testing, reagent sample again.
1-1-61
Stop resetting failure disk resetting failed. (2) Please contact the maintenance
Reagent sample disk After testing, zeroing reagent again.
1-1-62 Stop
zeroing failure sample disk failed. (2) Please contact the maintenance
When reading the instrument window, execute "Reset", and test
Instrument status status, the instrument status is again.
1-1-63 Stop
reading timeout not returned in the specified (2) Please contact the maintenance
time. personnel if it cannot return to
During testing, reagent Failure occurred when scanning
Sampling again.
1-1-64 remaining volume scan the remaining volume of
Stop (2) Please contact the maintenance
failure reagent during testing.
When scanning the remaining window, execute "Reset", and test
During testing, reagent
Sampling volume of reagent during again.
1-1-65 remaining volume scan
Stop testing, it is not completed in (2) Please contact the maintenance
timeout
specified time. personnel if it cannot return to
When the test is about to end, (1)After the instrument stands by,
When reaction disk is and the reaction disk is about to send the added test again.
1-1-66 Warning about to stop, adding a stop, if a test is added, the (2)Please contact the maintenance
test is abnormal instrument will not hanlde it, personnel if it cannot return to
and the alarm is prompted. normality or other failure occurs.
11-14
User Manual
Alarm
Alarm
code Grade
(1)Go to the system maintenance
When resetting, no probe window, and execute "Reset".
Probe control board
1-1-67 Warning control board reply is received (2)If it cannot return to normal or
resetting timeout
within specified time other failure occurs, please contact
the maintenance personnel.
When resetting, no reaction window, and execute "Reset".
Reaction disk control
1-1-68 Warning disk control board reply is (2)If it cannot return to normal or
board resetting timeout
received within specified time other failure occurs, please contact
When resetting, no reaction window, and execute "Reset".
AC control board
1-1-69 Warning disk control board reply is (2)If it cannot return to normal or
resetting timeout
When resetting, no ISE control window, and execute "Reset".
ISE control board
1-1-70 Warning board reply is received within (2)If it cannot return to normal or
resetting timeout
specified time other failure occurs, please contact
When resetting, no small white window, and execute "Reset".
Small white block
1-1-71 Warning block rinsing finish reply is (2)If it cannot return to normal or
rinsing timeout
Sampling (1)Please contact maintenance
3-11-1 Process failure Process failure
Stop personnel.
Abnormal (1) Call out system maintenance
Abnormal communication of
communication of window, and execute "reset".
Sampling probe control board and liquid
3-21-7 probe control board (2) If unable to revert to normal, or
Stop level detection board during
and liquid level other errors occur, please contact
resetting
detection board maintenance personnel in time.
(1) After having dispensed samples
Probe does not reach Probe does not reach the
window and execute "reset" under
Sampling the maximum point maximum point when
3-21-8 standby mode.
Stop when sample/reagent sample/reagent disk is to be
disk is to be started. started.
Probe control board waiting for
Sampling ISE triggering probe ISE control board triggering
Stop dispensing timeout ISE sample dispensing timeout
during ISE test
The probe control board
informs the abnormal
Probe board has failure communication between probe
Sampling when controlling the control board and reaction disk
3-21-10 personnel if it fails to recover to
Stop rotation of reaction or failure of reaction disk
normal after re-electrification.
disk mechanism mechanism when controlling
the rotation of reaction disk
mechanism
(1) Check if the sample/reagent is
used up, if the residual volume is
sufficient, after having dispensed
Touch occurs when the
Touch occurs when the probe samples tested, call out system
probe detects No.1
3-32-1 Warning detects No.1 position of maintenance window and execute
position of
sample/reagent disk "reset" under standby mode.
sample/reagent disk
11-15
User Manual
Alarm
Alarm
code Grade
probe detects No.2
position of
sample/reagent disk
probe detects No.3
position of
sample/reagent disk
probe detects No.4
position of
sample/reagent disk
probe detects No.5
position of
sample/reagent disk
probe detects No.6
position of
sample/reagent disk
probe detects No.7
position of
sample/reagent disk
probe detects No.8
position of
sample/reagent disk
11-16
User Manual
Alarm
Alarm
code Grade
probe detects No.9
position of
sample/reagent disk
probe detects No.10
position of
sample/reagent disk
probe detects No.11
position of
sample/reagent disk
probe detects No.12
position of
sample/reagent disk
probe detects No.13
position of
sample/reagent disk
probe detects No.14
position of
sample/reagent disk
probe detects No.15
position of
sample/reagent disk
11-17
User Manual
Alarm
Alarm
code Grade
probe detects No.16
position of
sample/reagent disk
probe detects No.17
position of
sample/reagent disk
probe detects No.18
position of
sample/reagent disk
probe detects No.19
position of
sample/reagent disk
probe detects No.20
position of
sample/reagent disk
probe detects No.21
position of
sample/reagent disk
probe detects No.22
position of
sample/reagent disk
11-18
User Manual
Alarm
Alarm
code Grade
probe detects No.23
position of
sample/reagent disk
probe detects No.24
position of
sample/reagent disk
probe detects No.25
position of
sample/reagent disk
probe detects No.26
position of
sample/reagent disk
probe detects No.27
position of
sample/reagent disk
probe detects No.28
position of
sample/reagent disk
probe detects No.29
position of
sample/reagent disk
11-19
User Manual
Alarm
Alarm
code Grade
probe detects No.30
position of
sample/reagent disk
probe detects No.31
position of
sample/reagent disk
probe detects No.32
position of
sample/reagent disk
probe detects No.33
position of
sample/reagent disk
probe detects No.34
position of
sample/reagent disk
probe detects No.35
position of
sample/reagent disk
probe detects No.36
position of
sample/reagent disk
11-20
User Manual
Alarm
Alarm
code Grade
probe detects No.37
position of
sample/reagent disk
probe detects No.38
position of
sample/reagent disk
probe detects No.39
position of
sample/reagent disk
probe detects No.40
position of
sample/reagent disk
probe detects outer
3-32-41 Warning detects outer No.1 position of maintenance window and execute
No.1 position of
sample/reagent disk
probe detects outer
No.2 position of
sample/reagent disk
probe detects outer
No.3 position of
sample/reagent disk
11-21
User Manual
Alarm
Alarm
code Grade
probe detects outer
No.4 position of
sample/reagent disk
probe detects outer
No.5 position of
sample/reagent disk
probe detects outer
No.6 position of
sample/reagent disk
probe detects outer
No.7 position of
sample/reagent disk
probe detects outer
No.8 position of
sample/reagent disk
probe detects outer
No.9 position of
sample/reagent disk
probe detects outer
No.10 position of
sample/reagent disk
11-22
User Manual
Alarm
Alarm
code Grade
probe detects outer
No.11 position of
sample/reagent disk
probe detects outer
No.12 position of
sample/reagent disk
probe detects outer
No.13 position of
sample/reagent disk
probe detects outer
No.14 position of
sample/reagent disk
probe detects outer
No.15 position of
sample/reagent disk
probe detects outer
No.16 position of
sample/reagent disk
probe detects outer
No.17 position of
sample/reagent disk
11-23
User Manual
Alarm
Alarm
code Grade
probe detects outer
No.18 position of
sample/reagent disk
probe detects outer
No.19 position of
sample/reagent disk
probe detects outer
No.20 position of
sample/reagent disk
probe detects outer
No.21 position of
sample/reagent disk
probe detects outer
No.22 position of
sample/reagent disk
probe detects outer
No.23 position of
sample/reagent disk
probe detects outer
No.24 position of
sample/reagent disk
11-24
User Manual
Alarm
Alarm
code Grade
probe detects outer
No.25 position of
sample/reagent disk
probe detects outer
No.26 position of
sample/reagent disk
probe detects outer
No.27 position of
sample/reagent disk
probe detects outer
No.28 position of
sample/reagent disk
probe detects outer
No.29 position of
sample/reagent disk
probe detects outer
No.30 position of
sample/reagent disk
probe detects outer
No.31 position of
sample/reagent disk
11-25
User Manual
Alarm
Alarm
code Grade
probe detects outer
No.32 position of
sample/reagent disk
probe detects outer
No.33 position of
sample/reagent disk
probe detects outer
No.34 position of
sample/reagent disk
probe detects outer
No.35 position of
sample/reagent disk
probe detects outer
No.36 position of
sample/reagent disk
probe detects outer
No.37 position of
sample/reagent disk
probe detects outer
No.38 position of
sample/reagent disk
11-26
User Manual
Alarm
Alarm
code Grade
probe detects outer
No.39 position of
sample/reagent disk
probe detects outer
No.40 position of
sample/reagent disk
probe detects inner
3-32-81 Warning detects inner No.2 position of maintenance window and execute
No.2 position of
sample/reagent disk
probe detects inner
No.3 position of
sample/reagent disk
probe detects inner
No.4 position of
sample/reagent disk
probe detects inner
No.5 position of
sample/reagent disk
probe detects inner
No.6 position of
sample/reagent disk
11-27
User Manual
Alarm
Alarm
code Grade
probe detects inner
No.7 position of
sample/reagent disk
probe detects inner
No.8 position of
sample/reagent disk
probe detects inner
No.9 position of
sample/reagent disk
probe detects inner
No.10 position of
sample/reagent disk
probe detects inner
No.11 position of
sample/reagent disk
probe detects inner
No.12 position of
sample/reagent disk
probe detects inner
No.13 position of
sample/reagent disk
11-28
User Manual
Alarm
Alarm
code Grade
probe detects inner
No.14 position of
sample/reagent disk
probe detects inner
No.15 position of
sample/reagent disk
probe detects inner
No.16 position of
sample/reagent disk
probe detects inner
No.17 position of
sample/reagent disk
probe detects inner
No.18 position of
sample/reagent disk
probe detects inner
No.19 position of
sample/reagent disk
probe detects inner
No.20 position of
sample/reagent disk
11-29
User Manual
Alarm
Alarm
code Grade
probe detects inner
No.21 position of
sample/reagent disk
probe detects inner
No.22 position of
sample/reagent disk
probe detects inner
No.23 position of
sample/reagent disk
probe detects inner
No.24 position of
sample/reagent disk
probe detects inner
No.25 position of
sample/reagent disk
probe detects inner
No.26 position of
sample/reagent disk
probe detects inner
No.27 position of
sample/reagent disk
11-30
User Manual
Alarm
Alarm
code Grade
probe detects inner
No.28 position of
sample/reagent disk
probe detects inner
No.29 position of
sample/reagent disk
probe detects inner
No.30 position of
sample/reagent disk
probe detects inner
No.31 position of
sample/reagent disk
probe detects inner
No.32 position of
sample/reagent disk
probe detects inner
No.33 position of
sample/reagent disk
probe detects inner
No.34 position of
sample/reagent disk
11-31
User Manual
Alarm
Alarm
code Grade
probe detects inner
No.35 position of
sample/reagent disk
probe detects inner
No.36 position of
sample/reagent disk
probe detects inner
No.37 position of
sample/reagent disk
probe detects inner
No.38 position of
sample/reagent disk
probe detects inner
No.39 position of
sample/reagent disk
probe detects inner
No.40 position of
sample/reagent disk
probe detects inner
No.1 position of
sample/reagent disk
11-32
User Manual
Alarm
Alarm
code Grade
Alarm caused by failure of (1) Call out system maintenance
Touch still occurs after lifting and zeroing optocoupler window, and execute "reset".
Sampling
3-32-200 the probe rises to at zeroing position by default (2) If unable to revert to normal, or
Stop
zeroing position. when the probe rises to zeroing other errors occur, please contact
position maintenance personnel in time.
The probe does not
The probe does not detect
detect sample at No.1 (1) If sample is placed at this position,
sample at No.1 position of
position of skip the rest test items.
3-33-1 Warning sample/reagent disk after
sample/reagent disk (2) Place sufficient samples at other
descending to the maximum
after descending to the positions to test the rest test items.
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-33
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not
3-33-11 position of skip the rest test items.
Warning sample/reagent disk after
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-34
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-35
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-36
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not (1) If sample is placed at this position,
detect sample or The probe does not detect skip the rest test items and place
reagent at outer No.1 sample or reagent at outer No.1 sufficient samples at other positions
3-33-41 Warning position of position of sample/reagent disk to test the rest test items.
sample/reagent disk after descending to the (2) If reagent is placed at this
after descending to the maximum distance position, skip the test item and click
maximum distance Dispense to dispense reagent.
11-37
User Manual
Alarm
Alarm
code Grade
detect sample or skip the rest test items and place
sample or reagent at outer
reagent at outer No.10 sufficient samples at other positions
No.10 position of
3-33-50 Warning position of to test the rest test items.
sample/reagent disk after
sample/reagent disk (2) If reagent is placed at this
after descending to the position, skip the test item and click
distance
No.11 position of
distance
No.12 position of
distance
No.13 position of
distance
No.14 position of
distance
No.15 position of
distance
No.16 position of
distance
No.17 position of
distance
11-38
User Manual
Alarm
Alarm
code Grade
No.18 position of
distance
No.19 position of
distance
No.20 position of
distance
No.21 position of
distance
No.22 position of
distance
No.23 position of
distance
No.24 position of
distance
No.25 position of
distance
No.26 position of
distance
11-39
User Manual
Alarm
Alarm
code Grade
No.27 position of
distance
No.28 position of
distance
No.29 position of
distance
No.30 position of
distance
No.31 position of
distance
No.32 position of
distance
No.33 position of
distance
No.34 position of
distance
No.35 position of
distance
11-40
User Manual
Alarm
Alarm
code Grade
No.36 position of
distance
No.37 position of
distance
No.38 position of
distance
No.39 position of
distance
No.40 position of
distance
The probe does not
detect reagent at inner
reagent at inner No.2 position
No.2 position of (1)Skip the test item and click
3-33-81 Warning of sample/reagent disk after
sample/reagent disk Dispense to dispense reagent.
after descending to the
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-41
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
No.9 position of (1) Skip the test item and click
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
No.11 position of (1) Skip the test item and click
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-42
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-43
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
11-44
User Manual
Alarm
Alarm
code Grade
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
The probe does not
distance
maximum distance
Water volume in
Water volume in rinsing pump tested and making the machine under
3-34-1 Warning rinsing pump reaches
reaches the upper limit. standby mode, contact maintenance
the upper limit.
personnel.
Insufficient water
Insufficient water volume in tested and making the machine under
3-34-2 Warning volume in rinsing
rinsing pump. standby mode, contact maintenance
pump.
personnel.
During testing, when
zeroing the rinsing During testing, when zeroing
(1)Wait for the test of added sample
pump, the remaining the rinsing pump, the remaining
Sampling to finish and the instrument to stand
3-34-3 volume is more than volume is more than the
Stop by. Contact the maintenance
the maximum maximum remaining volume
personnel.
remaining volume allowed by zeroing
allowed by zeroing
Receiving R1 reagent volume (1)After having dispensed samples
Receiving R1 reagent
Sampling dispensing information error. tested and making the machine under
3-81-1 volume dispensing
Stop Dispensing action converts to standby mode, contact maintenance
information error
probe rinsing action. personnel.
Receiving R2 reagent volume (1) After having dispensed samples
Receiving R2 reagent
information error
11-45
User Manual
Alarm
Alarm
code Grade
Receiving colorimetric sample
Receiving colorimetric (1)After having dispensed samples
volume dispensing information
Sampling sample volume tested and making the machine under
3-81-3 error. Dispensing action
Stop dispensing information standby mode, contact maintenance
converts to probe rinsing
error personnel.
action.
Receiving ISE sample volume (1)After having dispensed samples
Receiving ISE sample
information error
Invalid receiving of dispensing (1)After having dispensed samples
Invalid receiving of
Sampling position information. tested and making the machine under
3-81-5 dispensing position
information
Asynchronous validity of
Asynchronous validity
received dispensing position (1)After having dispensed samples
of received dispensing
Sampling information and dispensing tested and making the machine under
3-81-6 position information
Stop volume information. standby mode, contact maintenance
and dispensing volume
Dispensing action converts to personnel.
information
probe rinsing action.
Driver of probe Driver of probe mechanism (1)After having dispensed samples
Sampling mechanism swinging swinging motor has tested and making the machine under
3-101-6
Stop motor has configuration failure. Reading standby mode, contact maintenance
configuration failure. driver information failed. personnel.
Driver of probe Driver of probe mechanism (1)After having dispensed samples
Sampling mechanism lifting lifting motor has configuration tested and making the machine under
3-101-7
Stop motor has failure. Reading driver standby mode, contact maintenance
configuration failure. information failed. personnel.
Probe mechanism
Sampling Probe mechanism swinging tested and making the machine under
3-102-6 swinging motor has
Stop motor has short circuit. standby mode, contact maintenance
short circuit.
personnel.
Probe mechanism
Sampling Probe mechanism lifting motor tested and making the machine under
3-102-7 lifting motor has short
Stop has short circuit. standby mode, contact maintenance
circuit.
personnel.
Probe mechanism
Sampling Probe mechanism swinging tested and making the machine under
3-103-6 swinging motor has
Stop motor has open circuit. standby mode, contact maintenance
open circuit.
personnel.
Probe mechanism
Sampling Probe mechanism lifting motor tested and making the machine under
3-103-7 lifting motor has open
Stop has open circuit. standby mode, contact maintenance
circuit.
personnel.
Swinging and zeroing of probe
Swinging and zeroing fail to reach the zero point.
Sampling tested and making the machine under
3-104-6 of probe fail to reach Optocoupler is in abnormal
Stop standby mode, contact maintenance
the zero point. status after motor stops
personnel.
operating.
Lifting and zeroing of probe
Lifting and zeroing of fail to reach the zero point.
3-104-7 probe fail to reach the Optocoupler is in abnormal
zero point. status after motor stops
personnel.
operating.
Zeroing of syringe pump fails
Zeroing of syringe to reach the zero point.
3-104-8 pump fails to reach the Optocoupler is in abnormal
personnel.
operating.
Zeroing of rinsing pump fails to
Zeroing of rinsing reach the zero point.
3-104-9 pump fails to reach the Optocoupler is in abnormal
personnel.
operating.
11-46
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Alarm
Alarm
code Grade
Zeroing of reagent disk fails to
Zeroing of reagent disk reach the zero point.
3-104-10 fails to reach the zero Optocoupler is in abnormal
point. status after motor stops
personnel.
operating.
Swinging and positioning of tested, call out system maintenance
Swinging and
probe fail to reach the preset window and execute "reset" under
Sampling positioning of probe
3-105-6 position. Optocoupler is in standby mode.
Stop fail to reach the preset
abnormal status after motor (2) If unable to revert to normal, or
position.
stops operating. other errors occur, please contact
Positioning of reagent disk fails tested, call out system maintenance
Positioning of reagent to reach the preset position. window and execute "reset" under
Sampling
3-105-10 disk fails to reach the Optocoupler is in abnormal standby mode.
Stop
preset position. status after motor stops (2) If unable to revert to normal, or
operating. other errors occur, please contact
Abnormal initial position of tested, call out system maintenance
Abnormal initial
swinging and positioning of window and execute "reset" under
Sampling position of swinging
3-106-6 probe. Optocoupler is in standby mode.
Stop and positioning of
abnormal status before motor (2) If unable to revert to normal, or
probe.
starts operating. other errors occur, please contact
Positioning of reagent disk fails tested, call out system maintenance
Abnormal initial to reach the preset position. window and execute "reset" under
Sampling
3-106-10 position of positioning Optocoupler is in abnormal standby mode.
Stop
of probe. status before motor starts (2) If unable to revert to normal, or
operating. other errors occur, please contact
Swinging and zeroing failure of window and execute "reset" under
Sampling Swinging and zeroing
3-107-6 probe. Motor operating timeout standby mode.
Stop failure of probe.
or out of step. (2) If unable to revert to normal, or
Lifting and zeroing failure of window and execute "reset" under
Sampling Lifting and zeroing
3-107-7 probe. Motor operating timeout standby mode.
Stop failure of probe.
Zeroing failure of syringe window and execute "reset" under
Sampling Zeroing failure of
3-107-8 pump. Motor operating timeout standby mode.
Stop syringe pump.
Zeroing failure of rinsing window and execute "reset" under
3-107-9 pump. Motor operating timeout standby mode.
Stop rinsing pump.
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Alarm
code Grade
Zeroing failure of reagent disk. window and execute "reset" under
3-107-10 Motor operating timeout or out standby mode.
Stop reagent disk.
of step. (2) If unable to revert to normal, or
Swinging of probe window, and execute "reset".
Sampling Swinging of probe fails to leave
3-108-6 fails to leave the zero (2) If unable to revert to normal, or
Stop the zero point.
point. other errors occur, please contact
Descending of probe window, and execute "reset".
Sampling Descending of probe fails to
3-108-7 fails to leave the zero (2) If unable to revert to normal, or
Stop leave the zero point.
Sampling Syringe pump fails to Syringe pump fails to leave the
3-108-8 (2) If unable to revert to normal, or
Stop leave the zero point. zero point.
Sampling Rinsing pump fails to Rinsing pump fails to leave the
Sampling Reagent disk fails to Reagent disk fails to leave the
Swinging and Swinging and positioning window and execute "reset" under
Sampling
3-109-6 positioning failure of failure of probe. Motor standby mode.
Stop
probe. operating timeout or out of step. (2) If unable to revert to normal, or
Positioning failure of reagent window and execute "reset" under
Sampling Positioning failure of
3-109-10 disk. Motor operating timeout standby mode.
Stop reagent disk.
Sampling Fixed-angle swinging Probe swinging for fixed steps
Stop failure of probe. timeout.
Sampling Fixed-distance lifting Probe lifting for fixed steps
Stop failure of probe. timeout.
Quantitative aspirating window, and execute "reset".
Sampling Syringe pump operating for
3-110-8 and dispensing failure (2) If unable to revert to normal, or
Stop fixed steps timeout.
of syringe pump. other errors occur, please contact
11-48
User Manual
Alarm
Alarm
code Grade
Quantitative aspirating window, and execute "reset".
Sampling Rinsing pump operating for
3-110-9 and dispensing failure (2) If unable to revert to normal, or
Stop fixed steps timeout.
of rinsing pump. other errors occur, please contact
Sampling Fixed-angle rotation Reagent disk operating for
Stop failure of reagent disk. fixed steps timeout.
Probe swinging and coded disc
Swinging and coded window, and execute "reset".
Sampling scanning timeout or out of steps
3-111-6 disc scanning failure of (2) If unable to revert to normal, or
Stop or exceeding the number of
probe. other errors occur, please contact
scanning
Reagent disk coded disc
Sampling Coded disc scanning scanning timeout or out of steps
Stop failure of reagent disk or exceeding the number of
scanning
Bar code scanning and Bar code scanning and reagent window, and execute "reset".
Sampling
3-112-10 reagent disk operating disk operating timeout or out of (2) If unable to revert to normal, or
Stop
failure. steps. other errors occur, please contact
Abnormal swinging Abnormal swinging and window and execute "reset" under
Sampling
3-113-6 and positioning positioning verification of standby mode.
Stop
verification of probe. probe. (2) If unable to revert to normal, or
Abnormal swinging window and execute "reset" under
Sampling Abnormal swinging and coded
3-114-6 and coded disc standby mode.
Stop disc verification of probe.
verification of probe. (2) If unable to revert to normal, or
Abnormal coded disc window and execute "reset" under
Sampling Abnormal coded disc
3-114-10 verification of reagent standby mode.
Stop verification of reagent disk.
disk. (2) If unable to revert to normal, or
Abnormal swinging
Abnormal swinging and window and execute "reset" under
Sampling and positioning
3-115-6 positioning information standby mode.
Stop information calculation
calculation of probe. (2) If unable to revert to normal, or
of probe.
Sampling Probe does not swing Probe does not swing at the
Stop at the highest point. highest point.
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Alarm
Alarm
code Grade
Aspirating and
Aspirating and dispensing window and execute "reset" under
Sampling dispensing volume of
3-117-8 volume of syringe pump out of standby mode.
Stop syringe pump out of
limit. (2) If unable to revert to normal, or
limit.
Aspirating and
Aspirating and dispensing window and execute "reset" under
Sampling dispensing volume of
3-117-9 volume of rinsing pump out of standby mode.
Stop rinsing pump out of
limit. (2) If unable to revert to normal, or
limit.
Abnormal lifting and window and execute "reset" under
Abnormal lifting and zeroing
3-118-7 Warning zeroing verification of standby mode.
verification of probe.
probe. (2) If unable to revert to normal, or
Abnormal zeroing verification
of syringe pump. Motor
Abnormal zeroing window and execute "reset" under
operating steps from zero point
3-118-8 Warning verification of syringe standby mode.
to one point and the motor
pump. (2) If unable to revert to normal, or
operating steps from the
position to zero point.
Abnormal zeroing window and execute "reset" under
Abnormal zeroing verification
3-118-9 Warning verification of rinsing standby mode.
of syringe pump.
pump. (2) If unable to revert to normal, or
Positioning window, and execute "reset".
Sampling Positioning optocoupler failure
3-120-10 optocoupler failure of (2) If unable to revert to normal, or
Stop of reagent disk during resetting.
reagent disk. other errors occur, please contact
Positioning (1) Call out system maintenance
optocoupler is not at Positioning optocoupler is not window, and execute "reset".
Sampling
3-121-10 the present position at the present position after (2) If unable to revert to normal, or
Stop
after zeroing of reagent zeroing of reagent disk. other errors occur, please contact
disk. maintenance personnel in time.
Sampling Failure of water supply Failure of water supply valve
Stop valve V1 V1
Sampling Failure of inner wall
3-131-2 Failure of inner wall valve V2 standby mode.
Stop valve V2
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Alarm
code Grade
Sampling Failure of outer wall
3-131-8 Failure of outer wall valve V8 standby mode.
Stop valve V8
Sampling Open circuit of water Open circuit of water supply
Stop supply valve V1 valve V1
Sampling Open circuit of inner Open circuit of inner wall valve
Stop wall valve V2 V2
Sampling Open circuit of outer Open circuit of outer wall valve
Stop wall valve V8 V8
Mutually exclusive
Mutually exclusive solenoid window and execute "reset" under
solenoid valves are
3-133-11 3 valves are opened standby mode.
opened
simultaneously. (2) If unable to revert to normal, or
simultaneously.
Driver configuration window and execute "reset" under
Driver configuration failure of
3-134-1 2 failure of water supply standby mode.
water supply valve V1
valve V1 (2) If unable to revert to normal, or
3-134-2 2 failure of inner wall standby mode.
inner wall valve V2
3-134-8 2 failure of outer wall standby mode.
outer wall valve V8
Probe has collision in
Probe has collision in window and execute "reset" under
proportioning cup
3-141-1 2 proportioning cup when standby mode.
when dispensing ISE
dispensing ISE sample (2) If unable to revert to normal, or
sample
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Alarm
Alarm
code Grade
Probe does not detect tested, call out system maintenance
the liquid surface in Probe does not detect the liquid window and execute "reset" under
3-141-2 4 proportioning cup surface in proportioning cup standby mode.
when dispensing ISE when dispensing ISE sample (2) If unable to revert to normal, or
sample other errors occur, please contact
Probe does not detect
Probe does not detect the liquid window and execute "reset" under
the liquid surface when
3-141-3 4 surface when aspirating sample standby mode.
aspirating sample in
in cuvette (2) If unable to revert to normal, or
cuvette
Touch occurs when the Touch occurs when the probe window and execute "reset" under
3-141-4 2 probe aspirates diluted aspirates diluted sample in standby mode.
sample in cuvette cuvette (2) If unable to revert to normal, or
Probe tip detects the
Probe tip detects the liquid window and execute "reset" under
liquid surface when
3-141-6 4 surface when dispensing standby mode.
dispensing sample or
sample or reagent in cuvette (2) If unable to revert to normal, or
reagent in cuvette
Detection distance out
(1)Check liquid volume;
of limit in vertical Detection distance out of limit
(2)If errors occur in another
3-141-7 2 inspection and in vertical inspection and
execution, please contact
detection of 5mL detection of 5mL liquid surface
liquid surface
Detection distance out of limit (1)Check liquid volume;
of limit in vertical
in vertical inspection and (2)If errors occur in another
3-141-8 2 inspection and
detection of 50mL liquid execution, please contact
detection of 50mL
surface maintenance personnel in time.
liquid surface
Detection distance out of limit
of limit in vertical (1)Check liquid volume;
in vertical inspection and
inspection and (2)If errors occur in another
3-141-9 2 detection of 100uL liquid
detection of 100uL execution, please contact
surface at the side of reaction
liquid surface at the maintenance personnel in time.
disk
side of reaction disk
Detection distance out of limit
of limit in vertical (1)Check liquid volume;
in vertical inspection and
inspection and (2)If errors occur in another
3-141-10 2 detection of 300uL liquid
detection of 300uL execution, please contact
surface at the side of reaction
liquid surface at the maintenance personnel in time.
disk
side of reaction disk
Abnormal sensitivity window, and execute "reset".
Abnormal sensitivity of liquid
3-141-11 2 of liquid surface (2) If unable to revert to normal, or
surface detection board.
detection board. other errors occur, please contact
(1) Check if the empty bottle has
liquid inside and if the position is
of limit in vertical Detection distance out of limit
normal.
3-141-12 2 inspection and in vertical inspection and
(2) If errors occur in another
detection of 70mL detection of 70mL empty bottle
execution, please contact
empty bottle
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Alarm
code Grade
(1)Check whether the position of the
probe tip to the cuvette is correct;
Collision occurred
Collision occurred when the (2)Please contact the maintenance
when the probe
3-141-13 2 probe descends into the cuvette personnel.
descends into the
to dispense. (3)Please contact the maintenance
cuvette to dispense.
In vertical check of window, execute "Reset", and after
In vertical check of empty
empty bottle, detection the action, execute "Vertical Check".
3-141-14 2 bottle, detection automatic
automatic adjusment (2)Please contact the maintenance
adjusment failed.
failed. personnel if it cannot return to
3-161-1 1 Bar code setting failure Bar code setting failure (2) If unable to revert to normal, or
window and execute "bar code
Bar code reading
3-161-2 1 Bar code reading failure check" under standby mode.
failure
4-11-1 3 Process failure Process failure personnel.
(1) Resetting is required for
several times for first-time
Abnormal water water filling;
dispensing of rinsing (2) Check the liquid circuit if it (1)Please contact maintenance
4-11-2 3
probe of rinsing still fails after several times of personnel.
mechanism resetting;
personnel in time.
(1) Resetting is required for
several times for first-time
Abnormal water water filling;
aspirating of rinsing (2) Check the liquid circuit if it (1)Please contact maintenance
4-11-3 3
probe of rinsing still fails after several times of personnel.
mechanism resetting;
personnel in time.
Abnormal water
Abnormal water intaking of (1)No other alarms, please contact
4-11-5 3 intaking of rinsing
rinsing pump maintenance personnel.
pump
(1) If failure of probe mechanism is
caused by human factors, call out
Sample probe system maintenance window and
Sample probe unlocking
4-21-1 3 unlocking reaction execute "reset".
reaction disk timeout
disk timeout (2) Please contact maintenance
personnel for failures caused by
non-human factors.
Reagent probe R1 system maintenance window and
Reagent probe R1 unlocking
non-human factors.
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Alarm
Alarm
code Grade
Reagent probe R2 system maintenance window and
Reagent probe R2 unlocking
non-human factors.
Mixing mechanism
Mixing mechanism waiting
waiting stop of (1)Please contact maintenance
4-21-4 2 stop of reaction disk
reaction disk personnel.
mechanism timeout
mechanism timeout
Rinsing or mixing (1) Call out system maintenance
Rinsing or mixing mechanism
mechanism is not at window, and execute "reset".
is not at the highest position
4-21-5 3 the highest position (2) If unable to revert to normal, or
when the reaction disk is to
when the reaction disk other errors occur, please contact
rotate.
is to rotate. maintenance personnel in time.
Driver configuration
Driver configuration failure of window and execute "reset" under
failure of mixing
4-101-1 2 mixing mechanism swinging standby mode.
mechanism swinging
motor. (2) If unable to revert to normal, or
motor.
failure of mixing
4-101-2 2 mixing mechanism lifting standby mode.
mechanism lifting
motor. (2) If unable to revert to normal, or
motor.
Driver configuration window, and execute "reset".
4-101-3 3 failure of rinsing (2) If unable to revert to normal, or
rinsing mechanism motor.
mechanism motor. other errors occur, please contact
Driver configuration failure of window, and execute "reset".
failure of reaction disk
4-101-4 3 reaction disk mechanism lifting (2) If unable to revert to normal, or
mechanism lifting
motor. other errors occur, please contact
motor.
Mixing mechanism window and execute "reset" under
Mixing mechanism swinging
4-102-1 2 swinging motor has standby mode.
motor has short circuit.
short circuit. (2) If unable to revert to normal, or
Mixing mechanism lifting
4-102-2 2 lifting motor has short standby mode.
motor has short circuit.
circuit. (2) If unable to revert to normal, or
Rinsing mechanism Rinsing mechanism motor has
4-102-3 3 (2) If unable to revert to normal, or
motor has short circuit. short circuit.
Reaction disk window, and execute "reset".
Reaction disk mechanism
4-102-4 3 mechanism lifting (2) If unable to revert to normal, or
lifting motor has short circuit.
motor has short circuit. other errors occur, please contact
11-54
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Alarm
Alarm
code Grade
Mixing mechanism swinging
4-103-1 2 swinging motor has standby mode.
motor has open circuit.
open circuit. (2) If unable to revert to normal, or
Mixing mechanism lifting
4-103-2 2 lifting motor has open standby mode.
motor has open circuit.
circuit. (2) If unable to revert to normal, or
Rinsing mechanism Rinsing mechanism motor has
motor has open circuit. open circuit.
Reaction disk mechanism
4-103-4 3 mechanism lifting (2) If unable to revert to normal, or
lifting motor has open circuit.
motor has open circuit. other errors occur, please contact
Swinging and zeroing
Swinging and zeroing of window, and execute "reset".
of mixing mechanism
4-104-1 2 mixing mechanism fail to reach (2) If unable to revert to normal, or
fail to reach the zero
the zero point. other errors occur, please contact
point.
Lifting and zeroing of Lifting and zeroing of mixing window and execute "reset" under
4-104-2 2 mixing mechanism fail mechanism fail to reach the standby mode.
to reach the zero point. zero point. (2) If unable to revert to normal, or
Lifting and zeroing of Lifting and zeroing of rinsing window, and execute "reset".
4-104-3 3 rinsing pump fail to pump fail to reach the zero (2) If unable to revert to normal, or
reach the zero point. point. other errors occur, please contact
Zeroing of reaction window, and execute "reset".
Zeroing of reaction disk fails to
4-104-4 3 disk fails to reach the (2) If unable to revert to normal, or
reach the zero point.
zero point. other errors occur, please contact
Swinging and tested, call out system maintenance
positioning of mixing Swinging and positioning of window and execute "reset" under
4-105-1 2 mechanism fail to mixing mechanism fail to reach standby mode.
reach the preset the preset position. (2) If unable to revert to normal, or
position. other errors occur, please contact
Positioning of reaction Positioning of reaction disk window, and execute "reset".
4-105-4 3 disk fails to reach the fails to reach the preset (2) If unable to revert to normal, or
preset position. position. other errors occur, please contact
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Alarm
Alarm
code Grade
Abnormal initial
Abnormal initial position of window and execute "reset" under
position of swinging
4-106-1 2 swinging and positioning of standby mode.
and positioning of
mixing mechanism. (2) If unable to revert to normal, or
mixing mechanism.
Abnormal initial window, and execute "reset".
Abnormal initial position of
4-106-4 3 position of positioning (2) If unable to revert to normal, or
positioning of reaction disk.
of reaction disk. other errors occur, please contact
Swinging and zeroing window, and execute "reset".
Swinging and zeroing failure of
4-107-1 2 failure of mixing (2) If unable to revert to normal, or
mixing mechanism.
mechanism. other errors occur, please contact
Lifting and zeroing window and execute "reset" under
Lifting and zeroing failure of
4-107-2 2 failure of mixing standby mode.
mixing mechanism.
mechanism. (2) If unable to revert to normal, or
Lifting and zeroing window, and execute "reset".
Lifting and zeroing failure of
4-107-3 3 failure of rinsing (2) If unable to revert to normal, or
rinsing mechanism.
Zeroing failure of window, and execute "reset".
Zeroing failure of reaction disk
4-107-4 3 reaction disk (2) If unable to revert to normal, or
mechanism
mechanism other errors occur, please contact
Swinging of mixing window, and execute "reset".
Swinging of mixing mechanism
4-108-1 2 mechanism fails to (2) If unable to revert to normal, or
fails to leave the zero point.
leave the zero point. other errors occur, please contact
Lifting of mixing window, and execute "reset".
Lifting of mixing mechanism
fails to leave the zero point.
Rinsing mechanism window, and execute "reset".
Rinsing mechanism fails to
4-108-3 3 fails to leave the zero (2) If unable to revert to normal, or
leave the zero point.
Reaction disk mechanism fails
to leave the zero point.
Swinging and window and execute "reset" under
Swinging and positioning
4-109-1 2 positioning failure of standby mode.
failure of mixing mechanism.
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Alarm
Alarm
code Grade
Positioning failure of Positioning failure of reaction
reaction disk disk
Fixed-angle swinging window, and execute "reset".
Fixed-angle swinging failure of
4-110-1 2 failure of mixing (2) If unable to revert to normal, or
mixing mechanism.
Fixed-distance lifting Fixed-distance lifting or window, and execute "reset".
4-110-2 2 or descending failure descending failure of mixing (2) If unable to revert to normal, or
of mixing mechanism. mechanism. other errors occur, please contact
Fixed-distance lifting Fixed-distance lifting or window, and execute "reset".
4-110-3 3 or descending failure descending failure of rinsing (2) If unable to revert to normal, or
of rinsing mechanism. mechanism. other errors occur, please contact
Fixed-angle rotation window, and execute "reset".
Fixed-angle rotation failure of
4-110-4 3 failure of reaction disk (2) If unable to revert to normal, or
reaction disk mechanism
Swinging and coded Swinging and coded disc window, and execute "reset".
4-111-1 2 disc scanning failure of scanning failure of mixing (2) If unable to revert to normal, or
mixing mechanism. mechanism. other errors occur, please contact
Coded disc scanning window, and execute "reset".
Coded disc scanning failure of
4-111-4 3 failure of reaction disk (2) If unable to revert to normal, or
reaction disk mechanism
Abnormal swinging
Abnormal swinging and window and execute "reset" under
and positioning
4-113-1 2 positioning verification of standby mode.
verification of mixing
mechanism.
Abnormal swinging
Abnormal swinging and coded window, and execute "reset".
and coded disc
4-114-1 2 disc verification of mixing (2) If unable to revert to normal, or
verification of mixing
mechanism.
Abnormal coded disc Abnormal coded disc window, and execute "reset".
4-114-4 3 verification of reaction verification of reaction disk (2) If unable to revert to normal, or
disk mechanism. mechanism. other errors occur, please contact
Abnormal swinging Abnormal swinging and
and positioning positioning information
4-115-1 2 standby mode.
information calculation calculation of mixing
of mixing mechanism. mechanism.
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Alarm
Alarm
code Grade
Probe does not swing window, and execute "reset".
Probe does not swing at the
4-116-1 2 at the highest point (2) If unable to revert to normal, or
highest point during swinging.
during swinging. other errors occur, please contact
Abnormal lifting and Abnormal lifting and zeroing window and execute "reset" under
4-118-2 2 zeroing verification of verification of mixing standby mode.
mixing mechanism. mechanism. (2) If unable to revert to normal, or
Abnormal lifting and Abnormal lifting and zeroing window and execute "reset" under
4-118-3 3 zeroing verification of verification of rinsing standby mode.
rinsing mechanism. mechanism. (2) If unable to revert to normal, or
Rinsing mechanism is (1) Call out system maintenance
not at the highest point Rinsing mechanism is not at the window, and execute "reset".
4-119-4 3 and reaction disk highest point and reaction disk (2) If unable to revert to normal, or
mechanism does not mechanism does not rotate. other errors occur, please contact
rotate. maintenance personnel in time.
Positioning window, and execute "reset".
Positioning optocoupler failure
4-120-4 3 optocoupler failure of (2) If unable to revert to normal, or
of reaction disk.
reaction disk. other errors occur, please contact
Positioning (1) Call out system maintenance
optocoupler is not at Positioning optocoupler is not window, and execute "reset".
4-121-4 3 the present position at the present position after (2) If unable to revert to normal, or
after zeroing of zeroing of reaction disk. other errors occur, please contact
reaction disk. maintenance personnel in time.
4-131-7 tested, call out system maintenance
Open circuit of V7 at window and execute "reset" under
Open circuit of V7 at rinsing
2 rinsing bath of mixing standby mode.
bath of mixing mechanism
mechanism (2) If unable to revert to normal, or
Open circuit of rinsing Open circuit of rinsing window, and execute "reset".
4-131-6 3 mechanism No. 1 mechanism No. 1 probe valve (2) If unable to revert to normal, or
probe valve V6 V6 other errors occur, please contact
Open circuit of Open circuit of vacuum valve
vacuum valve V10 V10
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Alarm
Alarm
code Grade
Open circuit of Open circuit of detergent valve
detergent valve V9 V9
failure of V7 at rinsing
4-134-7 2 V7 at rinsing bath of mixing standby mode.
bath of mixing
mechanism (2) If unable to revert to normal, or
mechanism
failure of No. 1 probe
4-134-6 3 No. 1 probe valve V6 rinsing (2) If unable to revert to normal, or
valve V6 rinsing
mechanism
4-134-5 3 No. 2 probe valve V5 of rinsing (2) If unable to revert to normal, or
valve V5 of rinsing
mechanism
4-134-4 3 No. 3 probe valve V4 of rinsing (2) If unable to revert to normal, or
valve V4 of rinsing
mechanism
4-134-10 3 failure of vacuum (2) If unable to revert to normal, or
vacuum valve V10
valve V10 other errors occur, please contact
4-134-9 3 failure of detergent (2) If unable to revert to normal, or
detergent valve V9
valve V9 other errors occur, please contact
Abnormal ambient Short-circuit alarm of ambient
temperature sensor temperature sensor
Abnormal ambient Open-circuit alarm of ambient
Abnormal ambient Overhigh ambient temperature
temperature alarm
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Alarm
Alarm
code Grade
Abnormal ambient Too low ambient temperature
temperature alarm
Abnormal optical Short-circuit alarm of optical
Abnormal optical Open-circuit alarm of optical
Optical light source Optical light source is used for
use timeout alarm over 2000 hours
Abnormal incubation Incubation bath temperature window and execute "reset" under
5-4-2 1 bath temperature sensor is short or open standby mode.
sensor circuited. (2) If unable to revert to normal, or
After the incubation bath is (1) After having dispensed samples
continuously heated for 180s, tested, call out system maintenance
the temperature rise is less than window and execute "reset" under
Incubation bath
5-4-3 3 1℃. Heating band of standby mode.
heating overtime alarm
incubation bath or its (2) If unable to revert to normal, or
connecting line may be other errors occur, please contact
damaged. maintenance personnel in time.
Incubation bath fan Circulating fan of incubation
alarm bath stops working
Incubation bath Incubation bath temperature window and execute "reset" under
5-4-5 3 temperature control exceeds the lower limit during standby mode.
alarm PID control process (2) If unable to revert to normal, or
Incubation bath Incubation bath temperature window and execute "reset" under
5-4-6 3 temperature control exceeds the upper limit during standby mode.
alarm PID control process (2) If unable to revert to normal, or
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Alarm
code Grade
Abnormal pressure window and execute "reset" under
Open circuit alarm of pressure
5-10-1 3 sensor of diaphragm standby mode.
sensor of diaphragm pump
pump (2) If unable to revert to normal, or
Abnormal pressure
Communication error alarm of window and execute "reset" under
sensor of vacuum
5-10-2 3 pressure sensor of vacuum standby mode.
negative pressure
negative pressure pump (2) If unable to revert to normal, or
pump
Alarm of atmospheric tested, call out system maintenance
Alarm of atmospheric pressure
pressure beyond limit window and execute "reset" under
beyond limit read by pressure
5-10-3 3 read by pressure sensor standby mode.
sensor of vacuum negative
of vacuum negative (2) If unable to revert to normal, or
pressure pump
pressure pump other errors occur, please contact
Insufficient negative pressure
Abnormal vacuum window and execute "reset" under
alarm of vacuum negative
5-10-4 3 negative pressure standby mode.
pressure pump in resetting for
pump alarm (2) If unable to revert to normal, or
self inspection
Insufficient negative pressure
Abnormal vacuum window and execute "reset" under
alarm under test status before
5-10-5 3 negative pressure standby mode.
use of vacuum negative
pump alarm (2) If unable to revert to normal, or
pressure pump
When resetting, the vacuum
Vacuum negative window, and execute "Reset".
exhaust finish command of the
5-10-6 3 pressure resetting (2)If it cannot return to normal or
reaction disk control board is
abnormal other failure occurs, please contact
not received.
Abnormal reagent disk Short-circuit alarm of reagent
temperature sensor disk temperature sensor
Abnormal reagent disk Open-circuit alarm of reagent
temperature sensor disk temperature sensor
Alarm of temperature
Reagent disk exceeding upper refrigeration
refrigeration timeout limit after refrigeration of
reagent disk for 6h
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Alarm
Alarm
code Grade
Abnormal reagent disk Alarm of abnormal Peltier
Peltier current of reagent disk
Reagent disk Peltier reversely window and execute "reset" under
Too high reagent disk
5-11-5 1 connected or reverse wiring standby mode.
Peltier
sequence (2) If unable to revert to normal, or
Alarm of Peltier current of window and execute "reset" under
Abnormal Peltier
5-11-6 1 reagent disk out of normal standby mode.
current of reagent disk
range under test status (2) If unable to revert to normal, or
Abnormal temperature Short-circuit alarm of
sensor of temperature sensor of
constant-temperature constant-temperature degassing
degassing assembly assembly
Abnormal temperature Open-circuit alarm of
sensor of temperature sensor of
constant-temperature constant-temperature degassing
degassing assembly assembly
After the constant-temperature tested, call out system maintenance
Constant-temperature degassing assembly is window and execute "reset" under
5-13-3 1 degassing assembly continuously heated for 5min, standby mode.
heating timeout alarm the temperature rise is less than (2) If unable to revert to normal, or
1℃. other errors occur, please contact
(1) 10 minutes after testing stop, go to
Thermostatic degassing the system maintenance window, and
Thermostatic
assembly temperature is over execute "Reset".
5-13-4 3 degassing assembly
(2) Please contact the maintenance
temperature over high 50℃
(1) From the high-cocentration waste
liquid tank pull out the
high-concentration waste liquid float
out, empty the waste liquid tank, and
In the resetting status, the
High-concentration then insert the high-concentration
high-concentration waste liquid
5-15-1 3 waste liquid float waste liquid float.
in the waste liquid tank is over
floated up (2) Go to the system maintenance
much.
window, and execute "Reset".
(3)Please contact the maintenance
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Alarm
Alarm
code Grade
(1) Take out waste liquid float 1 from
waste liquid tank, empty the waste
liquid tank and then insert the waste
Waste liquid float 1 Alarm of too much waste liquid
5-15-2 1 liquid float again.
floating up alarm in waste liquid tank 1
(1) Take out waste liquid float 2 from
waste liquid tank, empty the waste
liquid tank and then insert the waste
Waste liquid float 2 Alarm of too much waste liquid
5-15-3 1 liquid float again.
floating up alarm in waste liquid tank 2
(1) From the low-cocentration waste
liquid tank pull out the
low-concentration waste liquid float
out, empty the waste liquid tank, and
then insert the low-concentration
In the resetting status, the waste liquid float.
Low-concentration
light-concentration waste liquid (2) Go to the system maintenance
5-15-4 3 waste liquid float
in the waste liquid tank is over window, and execute "Reset".
floated up
much. (3)Please contact the maintenance
(4) Please contact the maintenance
(1)Add pure water to tank
Alarm of insufficient pure
Pure water float falling window and execute "reset" under
5-19-1 3 water in pure water tank under
down alarm standby mode.
resetting status
(1)Add pure water to tank
Under the test status, the
Pure water float falling window and execute "reset" under
5-19-2 2 insufficient pure water in pure
down alarm standby mode.
water tank lasts for 3min
(1) Add pure water to tank
Alarm of insufficient pure
Pure water float falling (2) If unable to revert to normal, or
5-19-3 1 water in pure water tank under
down alarm other errors occur, please contact
test status
(1) Add alkaline detergent to alkaline
detergent bottle
Detergent float falling Alarm of insufficient alkaline
down alarm detergent
Dilution pump fails to reach the window and execute "reset" under
Zeroing of dilution
17-1-1 2 zero point when executing standby mode.
pump failed
zeroing action (2) If unable to revert to normal, or
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Alarm
Alarm
code Grade
Dilution pump fails in Dilution pump fails to leave the
leaving the zero point zero point when having action
Dilution pump is not at window and execute "reset" under
Dilution pump is not at the zero
17-1-3 2 the zero point during standby mode.
point during ISE test
ISE test (2) If unable to revert to normal, or
Abnormal pressure of Abnormal vacuum pump or
vacuum pump vacuum tubing
Abnormal pressure relief is window and execute "reset" under
Abnormal pressure
17-1-5 2 caused by blockage of vacuum standby mode.
relief of vacuum pump
pump tubing or solenoid valve (2) If unable to revert to normal, or
Sample mechanism fails to
Waiting for sample finish sample dispensing in
timeout regulated time period during
ISE test
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Chapter 12 Transport and storage
12.1 Transport
The transport of Analyzer is specified in the contract, during which fierce collision, rain and exposure to sun shall be
prevented, also the Analyzer shall not be placed together with corrosive materials.
12.2 Storage
The packed Analyzer shall be stored in an indoor space that is clean, ventilated and free of chemicals and corrosive
gas, and with ambient temperature of -40℃~55℃ and relative humidity of no more than 93%.
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Appendix A Letter of guarantee

Dear user,
Thanks for purchasing Auto-Chemistry Analyzer (model: MISPA CXL PRO). Our company offers the
following services: (1)Technical consultation at any time.
(2) One-year free warranty for the complete machine from the date of purchase; and Free repair service for any fault
caused due to design/ manufacturing defects within the warranty period.
(3)Paid services in the following cases:
a)The product out of warranty.
b) Product damage due to an accident or improper use.
c) Product damage due to non-compliance with the Instructions.
d) Product damage due to repair without permission of our company
(4) With the development of technologies, our company will also provide update service of the Analyzer.
For technical support, contact us through the following address and telephone:
Global Access Point:-
Agappe Diagnostics Switzerland GmbH,

Knonauerstrasse 54 – 6330,
Cham, Switzerland
Tel:- +41 41 780 60 10 | Fax:- +41 41 780 60 11
Corporate Office (Asia Pacific Office):-
Agappe Diagnostics Ltd,

Agappe Hills, Kochi, Kerala 683562, India
Tel:- +91 484 287 7000 | Fax:- +91 484 286 7222
Website: www.agappeswiss.com
Mail: info@agappeswiss.com | marketing@agappeswiss.com | service@agappeswiss.com
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Appendix B Product description
B.1 Product classification

According to the classified catalog for medical instrument products, Auto-Chemistry Analyzer is a biochemistry
analyzer belonging to clinical analyzers (6840), and the management class is Class II.
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Appendix D Cross contamination reference table
Item name Principle of the method Polluted items Principle of the method
TG Oxidase method → TBA Cycling enzyme method
TC Enzyme method → TBA Cycling enzyme method
CHE Substrate hydrolysis → TG Oxidase method
LDL-C Direct determination → GLU(OX) Oxidase method
HDL-C Direct determination → GLU(OX) Oxidase method
CK IFCC recommended method → Mg Methylene blue
FMN NBT restoration method → CHE Substrate hydrolysis
The above cross contamination is only suitable for the reagent of AGAPPE Company on the Analyzer, and the
changes of the reagent will impact the cross contamination condition, so the above condition is only the reference for
testing, and the actual condition shall prevail in case of matters not covered.
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Appendix E Reference of abnormal result marks
Mark Meaning Color

H or ↑ Result exceeds upper limit Settable
L or ↓ Result exceeds lower limit Settable
Sample testing without sample
S QC testing without QC liquid Settable
R Never added reagent Settable

! Add neither sample not reagent Settable
> Concentration beyond upper limit of reagent linearity range Settable
< Concentration beyond lower limit of reagent linearity range Settable
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Appendix F LIS Network Interface Instruction V1.01

1. Interface Overview
HL7 is standardized health information transmitting protocol which is used for electronic transmission among
different applications in medical field. HL7 collects standard formats used by different manufactures to design
interfaces among different application software and allows data communication among different systems. It is
defined firstly by American and is widely used by many countries until now.
The transmission format in this interface is created according to HL7 version 2.3.1.
1.1 HL7 Message Structure
In HL7 communication protocol, message is basic unit of data transmitted among systems. Each message has its
own message type, which is used for defining message purpose and contains trigger events. One message is
composed of many segments. Each segment has its own name, which is used for defining its content or function.
One segment is composed of many Data Field. The first segment of a message is always message head segment,it
indicates sending and receiving program name, message type, and the only message ID, etc. the following segments
are decided by message type. E.g. PID segment (Patient Identification Data) includes name, address, social insurance
No. etc. One data segment can be composed of many parts and some messages may subdivided by event code.
This interface is defined upon HL7 v2.3.1, refer to HL7 Interface Standards Version 2.3.1 for detail.
1.2 HL7 Underlying Protocol
TCP/IP is a byte stream protocol, and it does not provide message boundaries. As upper layer protocol, HL7 is based
upon message, but it does not provide message end facility. In order to confirm message boundary, we adopts the
minimum underlying protocol(it is also described in HL7 Interface Standards Version 2.3.1.).The beginning of a
message is single byte, the ending of a message is double byte.
Message will be transmitted in the following formats:
<SB> data <EB><CR>,
<SB> = Start Block character (1 wide char), ASCII <VT>,which is 0x0B.
data = Data (variable number of wide chars), data is HL7 message, only includes ISO 8859-1 character (hex
decimal value 20 - FF) and <CR>, excludes other control and can not be printed characters.
<EB> = End Block character (1 wide char), ASCII <FS>, which is 0x1C.
<CR> = Carriage Return (1 wide char), ASCII Carriage Return, which is 0x0D.
Remark: This protocol adopts Unicode code, all send, received character strings are Unicode.
2. Communication Format
This communication interface includes test result transmission and sample information application. Test result
transmission is to transmit sample information, test result and QC result of analyzer to outer system, such as LIS.
The transmission method includes real time transmission during test and history result batch transmission. Sample
information application is to obtain the required sample information from LIS.
2.1 Support HL7 Message
All HL7 messages used in this interface are ORU, ACK, QRY and DSR.
The general view of test result transmission is as follow:
The general view of sample result application is as follow:
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ORU/ACK: Non-request observe report /response. The main function of ORU^R01 message is transmitting lab
results(sample information, test result, QC result ) in HL7.
The transmitted information and test results include:
Patient information(patient name, sample No. etc.)
Doctor’s advice information(sample type, send doctor, test doctor, clinical diagnosis, etc.)
Test result
It is a group of messages, one message corresponds to one sample information(one sample information may includes
many item results) . LIS system can use these content according to requirements. The specific structure is as follow:
ORU Observational Results (Unsolicited) Description
MSH Message head
PID Patient information
OBR Observe report
{OBX} Test result
The transmitted test result includes the following

information:
Item information(item No., item name)
Control related information(QC times, QC name, QC lot No., etc.)
QC date, test result
One message will send one QC test. The send structure of QC result is as follow:
MSH Message head
OBR QC observe report
ACK^R01: Message is used for responding ORU message. The specific structure is as follow:
MSH Message head
MSA Message acknowledge
QRY/QCK: Query observe result /response. QRY^Q02 message query current data, used for query required sample
information from LIS system. The specific structure is as follow:
QRY Query Description
MSH Message head
QRD Query definition
QRF Query screen
DSR/ACK: Response to QRY message, display/response of observe result. One function of DSR^Q03 message is
to respond QRY message, the other function is send display of query result, which is sending sample information
of LIS to analyzer. The specific structure is as follow:
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DSR Display Response Description

MSH Message head
{DSP} Display data
ACK^Q03 message is used for responding DSR message. The specific structure is as follow:
ACK Acknowledgment Description
MSH Message head
2.2 Message Segment

All fields used in message segments will be introduced in detail, in which, # behind No. is required segment
specified by HL7. The unused segments will not be omitted for future expansion.
1. MSH Message Header
MSH is the head of HL7 message, which is in the front of message and all messages are started with MSH. MSH
is used for defining message purpose, origin and grammar.
MSH of this interface uses the following fields:
No. Segment Name Length Explanation
Includes the separator between segment ID and
1# Field Separator 1 the first real field, the left field separator (|).
Includes assembly separator, repeat separator,
2# Encoding Characters 4 transfer separator and subassembly
separator(^~\&).
3 Sending Application 180 Application program of send end.
4 Sending Facility 180 Empty, keep. Facility of send end.
5 Receiving Application 180 Application program of receive end.
6 Receiving Facility 180 Empty, keep. Facility of receive end.
Time of current message. Adopt the time of the
7 Date/Time Of Message 26 system.
8 Security 40 Empty, keep. Security
9# Message Type 7 Message type, e.g.: ORU^R01.
Message control ID, unique marking one
10# Message Control ID 20 message, increase from 1 as message No.
increases.
11# Processing ID 3 Process ID, P(product).
12# Version ID 60 Version ID,HL7 Protocol Version: 2.3.1.
13 Sequence Number 15 Empty, keep. Sequence No.
14 Continuation Pointer 180 Empty, keep. Continuation Pointer
15 Accept Acknowledgment Type 2 Empty, keep. Accept Acknowledgment Type
Application Acknowledgment Type, as send
result type. 0-patient sample test result;
16 Application Acknowledgment Type 2
1-calibration result；2-QC result；
In which, "1-calibration result" is not supported.
17 Country Code 2 Empty, keep. Country Code
18 Character Set 10 Character Set, take UNICODE.
19 Principal Language Of Message 60 Empty, keep. Principal Language Of Message
Alternate Character Set Handling Empty, keep. Alternate Character Set Handling
20 Scheme 20 Scheme
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Remark: This segment presents in all messages. In HL7 message send from LIS system to analyzer, the 3rd, 4th
segment value will be decided by LIS manufacture, the 5th ,6th segment will be set by user in software. The 10th ,
16th segment will use integer. Other segment will use character string type.
2. MSA - message acknowledgment segment
MSA of this interface use the following fields:
No. Segment Name Length Explanation
Acknowledgment Code, AA indicates accept; AE
indicates error; AR indicates refuse, OK indicates data is
1# Acknowledgment Code 2
queried. NF indicates data is not found. OK and NF are
available in DSR^Q03.
2# Message Control ID 20 Message Control ID, same as MSH-10 of sender.
Text message, text description of a event in case of error
3 Text Message 80 or refuse. Corresponds with the 6th segment, and can be
used to write wrong log.
Expected Sequence
4 Number 15 Empty, keep. Intended sequence No.
Delayed Acknowledgment
5 Type 1 Empty, keep. Delayed Acknowledgment Type
6 Error Condition 100 Error Condition(Status Code).
MSA-6 segment value is as follow:

Status Code(MSA-6) Status Text(MSA-3) Description/Remark
Succeed AA
0 Message accepted Succeed
Query Succeed OK
0 Data found, not errors Query Succeed
Data is not found in query. NF
0 No data found, not errors Data is not found in query.
Wrong status code AE
Sequence of segments in message is incorrect,
100 Segment sequence error or necessary segment is lost.
101
Required field missing Necessary segment is lost.
Data type of segment is incorrect, such as
102 Data type error character instead of number.
103 Table value not found Table value is not found.
Refuse status code AR
200 Unsupported message type Unsupported message type
201 Unsupported event code Unsupported event code
202 Unsupported processing id Unsupported processing ID
203 Unsupported version id Unsupported version ID
Unknown key identifier, such as non-exist
204 Unknown key identifier patient information is transmitted.
205 Duplicate key identifier Duplicate key identifier exists.
Event can not be carried out in application
206 Application record locked program storage level, such as database is
locked.
207 Application internal error Unclear internal error.
Remark: This message segment may present in ACK^R01, DSR^Q03, ACK^Q03. The 4th, 6th segment use
integer, and other segments use character string type.
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3. PID Patient Identification

PID mainly used for structure patient information. PID of this interface adopts the following fields:
No. Segment Length Explanation
1 Set ID – PID 10 Acknowledge different patient message segment.
2 Patient ID 20 Empty, keep. Patient No. in hospital.
3# Patient Identifier List 16 Case No.
4 Alternate Patient ID – PID 10 Bed No.
5# Patient Name 30 Patient Name
Inpatient Area and Ward. Area and ward are separated
6 Mother’s Maiden Name 61 by ^.The inpatient area length is 30, ward length is 30.
7 Date/Time of Birth 26 Empty, keep. Patient date of birth.
8 Sex 1 Send M for male; F for female; O for other.
9 Patient Alias 48 Empty, keep. Blood type.
10 Race 80 Empty, keep. Empty, keep. Race
11 Patient Address 106 Empty, keep. Patient Address
12 County Code 4 Empty, keep. County Code
13 Phone Number -Home 40 Empty, keep. Phone Number
14 Phone Number -Business 40 Empty, keep. Empty, keep. Phone Number -Business
15 Primary Language 60 Empty, keep. Empty, keep. Primary Language
16 Marital Status 80 Empty, keep. Empty, keep. Marital Status
17 Religion 80 Empty, keep. Empty, keep. Religion
18 Patient Account Number 30 Patient type
19 SSN Number -Patient 16 Empty, keep. SSN Number -Patient
Driver's License Number –
20 Patient 25 Empty, keep. Charge type.
21 Mother's Identifier 20 Empty, keep. Mother's Identifier

22 Ethnic Group 30 Ethnic Group
23 Birth Place 60 Empty, keep. Birth Place
Empty, keep. Empty, keep. Multiple Birth Indicator. Y
24 Multiple Birth Indicator 1 indicates Yes, N indicates No.
Empty, keep. Birth Order, which is whole number(larger
25 Birth Order 2 than 0) .
26 Citizenship 100 Remark
27 Veterans Military Status 60 Empty, keep. Veteran status
28 Nationality 80 Empty, keep. Nationality
Patient Death Date and
29 Time 26 Empty, keep. Patient Death Date and Time
Empty, keep. Patient Death Indicator. Y indicates Yes,
30 Patient Death Indicator 1 N indicates No.
Age and age unit. Age and age unit are separated by ^.
Age is whole number, length is 3. Age unit is character
31 Patient Age 5
string, length is 1. Send Y for age, M for month, D for
day, H for hour.
Remark: This message segment is only used in ORU^R01. The age segment of 1st ,25th ,31st segment use
integer data type. Other segment use character string data type.
4. OBR Observation Request
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OBR segment is used for transmitting doctor’s advice related to test report. When transmitting test results of
patient’s sample,
(MSH-16 take 0), OBR of this interface uses the following fields:
1 Set ID – OBR 10 Confirm different OBR segment.
2 Placer Order Number 22 Placer Order Number, used for sample barcode.
3 Filler Order Number 5 Filler Order Number, used for sample No.
4# Universal Service ID 200 Universal Service identifier.
5 Priority 2 Priority or not ? Y indicates yes, N indicates No.
6 Requested Date/time 26 Empty, keep. Requested Date/time
7 Observation Date/Time 26 Observation Date/Time, used for test Date/Time.
8 Observation End Date/Time 26 Empty, keep. Observation End Date/Time
9 Collection Volume 3 Used for repeat test times, take 1.
Collector Identifier. Used for sample and position.
Sample rack and position shall be separated by ^.
10 Collector Identifier 8 Sample rack length is 4, position length is 3.If the
analyzer is CXL PRO1300 or CXL PRO1600, then
this segment indicates sample disk No. and sample
position.
11 Specimen Action Code 1 Empty, keep. Specimen Action Code
Danger Code. Used for dilute or not. Y indicates yes, N
12 Danger Code 1 indicates No.
Related clinical information, used for patient clinical
13 Relevant Clinical Info. 100 diagnosis information.
Specimen Received
14 Date/Time 26 Send date/time.
Specimen Source, used for sample type, such as serum,
15 Specimen Source 1 plasma, urine, etc. 0-Serum, 1-Urine, 2-Plasma, 3- CSF,
4- Gastric juice, 5-Ascites, 6-Other.
16 Ordering Provider 30 Ordering Provider, used for send doctor.
Order Callback Phone
17 Number 30 Used for send dept.
Empty, keep. Sample character(jaundice, hemolysis,
18 Placer Field 1 60 lipohemia).
19 Placer Field 2 60 Empty, keep. Blood bag No.
20 Filler Field 1 30 Physician-in-charge, used for test doctor.
21 Filler Field 2 60 Empty, keep. Treatment dept.
Result Rpt/Status Change –
22 Date/Time 26 Result report date/time.
23 Charge to Practice 40 Empty, keep. Charge to Practice

24 Diagnostic Serv Sect ID 10 Empty, keep. Diagnosis ID.
25 Result Status 1 Empty, keep. Result Status
26 Parent Result 200 Empty, keep. Parent Result
27 Quantity/Timing 200 Empty, keep. Quantity/Timing
28 Result Copies To 150 Empty, keep. Result Copies To
29 Parent 150 Empty, keep. Parent
30 Transportation Mode 20 Empty, keep. Transportation Mode
31 Reason for Study 300 Empty, keep. Reason for Study
32 Principal Result Interpreter 30 Principal Result Interpreter, used for checker.
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33 Assistant Result Interpreter 200 Empty, keep. Assistant Result Interpreter
34 Technician 200 Empty, keep. Technician
35 Transcriptionist 200 Empty, keep. Transcriptionist
36 Scheduled Date/Time 26 Empty, keep. Scheduled Date/Time
Number of Sample
37 Containers 4 Empty, keep. Number of Sample Containers
Transport Logistics of
38 Collected Sample 60 Empty, keep. Transport Logistics of Collected Sample
39 Collector’s Comment 200 Empty, keep. Collector’s Comment

Transport Arrangement
40 Responsibility 60 Empty, keep. Transport Arrangement Responsibility
41 Transport Arranged 30 Empty, keep. Transport Arranged

42 Escort Required 1 Empty, keep. Escort Required
Planned Patient Transport
43 Comment 200 Empty, keep. Planned Patient Transport Comment
44 Ordering Facility Name 60 Empty, keep. Ordering Facility Name

45 Ordering Facility Address 106 Empty, keep. Ordering Facility Address
Ordering Facility Phone
46 Number 48 Empty, keep. Ordering Facility Phone Number
47 Ordering Provider Address 106 Empty, keep. Ordering Provider Address
Remark: This message is only used in ORU^R01. Sample position segment of the 1st, 3rd, 9th, 10th segment. 15th,
37th segment use integer data type. Other segments use character string data type.
When transmitting QC results(MSH-16 is 2). Its segment definition is as follow:
1 Set ID – OBR 10 Confirm different OBR segment.
2 Placer Order Number 22 Placer Order Number, used for sample barcode.
3 Filler Order Number 5 Filler Order Number, used for sample No.
4# Universal Service ID 200 Universal Service ID
5 Priority 2 Priority or not, Y indicates yes, N indicates No.
6 Requested Date/time 26 Empty, keep. Requested Date/time
7 Observation Date/Time 26 Observation Date/Time, used for QC date/time.
8 Observation End Date/Time 26 Empty, keep. Observation End Date/Time
9 Collection Volume 20 Empty, keep.
Collector Identifier. Used for sample rack and position.
Sample rack and position shall be separated by ^.
10 Collector Identifier 8 Sample rack length is 4, position length is 3.If the
analyzer is CXL PRO1300 or CXL PRO1600, then
this segment indicates sample disk No. and sample
position.
11 Specimen Action Code 5 Used for QC times.
Used for module and inner&outer circle mark. Module
and inner&outer circle are separated by ^. 1 indicates
12 Danger Code 3
outer circle. 2 indicates inner circle. 3 indicates inner &
outer circle.
13 Relevant Clinical Info. 20 Used for QC name.
Specimen Received
14 Date/Time 26 Empty, keep.
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Specimen Source, used for sample type, such as serum,
15 Specimen Source 1 plasma, urine, etc. 0-Serum, 1-Urine, 2-Plasma, 3- CSF,
4- Gastric juice, 5-Ascites, 6-Other.
16 Ordering Provider 15 Used for QC lot No.
Order Callback Phone
17 Number 10 Used for mean.
18 Placer Field 1 10 Used for standard deviation.

19 Placer Field 2 10 Used for QC result.
20 Filler Field 1 12 Used for result unit.
Used for result mark.
If the absolute difference between result and mean is not
smaller than SD, and smaller than 2SD, return +1SD(or
-1SD);
21 Filler Field 2 10 If the absolute difference between result and mean is not
smaller than 2SD, and smaller than 3SD, return +2SD(or
-2SD);
smaller than 3SD, return +3SD(or -3SD).
Result Rpt/Status Change –
22 Date/Time 26 Empty, keep. Result report date /time.
Used for QC rule
smaller than SD, and smaller than 2SD, return blank;
23 Charge to Practice 10 If the absolute difference between result and mean is not
smaller than 2SD, and smaller than 3SD, return 1-2s;
smaller than 3SD, return 1-3s.
24 Diagnostic Serv Sect ID 10 Empty, keep. Diagnosis part ID.
25 Result Status 1 Empty, keep. Result status.
26 Parent Result 200 Empty, keep. Parent Result
27 Quantity/Timing 200 Empty, keep. Quantity/Timing
28 Result Copies To 150 Empty, keep. Result Copies To
29 Parent 150 Empty, keep. Parent
30 Transportation Mode 20 Empty, keep. Transportation Mode
31 Reason for Study 300 Empty, keep. Reason for Study
32 Principal Result Interpreter 30 Empty, keep. Principal Result Interpreter
33 Assistant Result Interpreter 200 Empty, keep. Assistant Result Interpreter
34 Technician 200 Empty, keep. Technician
35 Transcriptionist 200 Empty, keep. Transcriptionist
36 Scheduled Date/Time 26 Empty, keep. Scheduled Date/Time
Number of Sample
37 Containers 4 Empty, keep. Number of Sample Containers
Transport Logistics of
38 Collected Sample 60 Empty, keep. Transport Logistics of Collected Sample
39 Collector’s Comment 200 Empty, keep. Collector’s Comment

Transport Arrangement
40 Responsibility 60 Empty, keep. Transport Arrangement Responsibility
41 Transport Arranged 30 Empty, keep. Transport Arranged

42 Escort Required 1 Empty, keep. Escort Required
Planned Patient Transport
43 Comment 200 Empty, keep. Planned Patient Transport Comment
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44 Ordering Facility Name 60 Empty, keep. Ordering Facility Name
45 Ordering Facility Address 106 Empty, keep. Ordering Facility Address
Ordering Facility Phone
46 Number 48 Empty, keep. Ordering Facility Phone Number
47 Ordering Provider Address 106 Empty, keep. Ordering Provider Address
Remark: This message is only used in ORU^R01. Sample position segment of the 1st, 10th segment. Module
segment and inner&outer circle mark segment of 11st, 12th segment. The 15th segment uses integer data type. 17
th
,18 th,19 th segment use floating number. Other segments use character string data type.
5. OBX Observation
OBX mainly used for transmitting observed information in report message. If the transmitted data are sample
information(MSH-16 is 0), one patient may with many OBX. The OBX segment of this interface use the following
field:
1 Set ID – OBX 10 Confirm different OBX segment.
Value Type, used for mark test result type. NM
(numeric) indicates numeric value, used for quantify
2 Value Type 3
item ST (string) indicates character string value, used for
qualitative item.
3# Observation Identifier 5 Observe identifier, used for item ID number.
Observe, Sub-ID, used for item name and repeat test
4 Observation Sub-ID 16 times. Item name and repeat test times will be separated
by ^, item name length 12, repeat test times length 3.
Observe value, used for test result value(result
5 Observation Value 16 concentration or negative, positive, etc.)
6 Units 12 Unit, used as the unit of test result.
7 References Range 30 Reference range, test result normal range.
Abnormal mark, whether test result is
8 Abnormal Flags 5 normal(description)L-low H-high N-normal.
9 Probability 5 Empty, keep. Possibility
Empty, keep. Used as result mark. F-test result,
10 Nature of Abnormal Test 5 C-recheck result.
11# Observe Result Status 1 Empty, keep. Observe result status.
Date Last Observe Normal
12 Values 26 Empty, keep. Observe normal value date at last.
User Defined Access
13 Checks 16 User-define access check, used for original result.
Date/Time of the
14 Observation 28 Observe date/time, used for test date/time.
15 Producer's ID 30 Result producer’s ID.

16 Responsible Observer 30 Responsible observer, used for test doctor.
17 Observation Method 60 Empty, keep. Observe method.
Remark: This message segment presents only in ORU^R01 message. The repeat test segment of 1st, 3rd, 4th
segments use integer data type. The 5th, 13rd segment use floating point data type. Other segments use character
string data type.
6. QRD - query definition segment
The ORD segment of this interface use the following fields:
1# Query Date/Time 26 Time of this query, the system time.
F-9
User Manual

Query format code, query method, take SN(indicates
2# Query Format Code 2 sample No. method)and BC(indicates sample barcode
method)
3# Query Priority 1 Query priority, take D(deferred),.
Query ID, represents different queries, it increase 1 as
4# Query ID 10 the query number increases.
5 Deferred Response Type 1 Empty, keep. Delay response type.
Deferred Response
6 Date/Time 26 Empty, keep. Delay response date/time.
7# Quantity Limited Request 10 Quantity Limited Request, take RD(Records).

Who Subject Filter, if QRD-2 is SN, this segment is
8# Who Subject Filter 30 used as sample No., if QRD-2 is BC, this segment is
used as sample barcode.
9# What Subject Filter 60 Empty, keep. What Subject Filter
Used as sample rack and position. Sample rack and
position will be separated by ^, sample rack length is 4,
sample position length is 3.
What Department Data
10# 8 Sample rack and position require LIS to return original
Code
value in DSR^Q03.If analyzer is CXL PRO1300 or
CXL PRO1600,
this segment represents sample disk No. and sample
position.
Used for dilution, Y indicates conduct dilution, N
What Data Code Value
11 1 indicates not conduct dilution. Whether to dilute require
Qual.
LIS to return original value in DSR^Q03.
12 Query Results Level 1 Empty, keep. Query result level, take T(Full results)
Remark: This message segment presents in QRY^Q02. The 4th segment is integer data type. Other segments use
character string data type.
7. QRF - query filter segment
QRF segment and QRD segment shall be used together to further refine original query content. The QRF segment
of this interface uses the following fields:
1# Where Subject Filter 20 Querier place filter.

Record start date/time, used for start time of receiving
2 When Data Start Date/Time 26 sample in query.
Record end date/time, used for end time of receiving sample
3 When Data End Date/Time 26 in query.
4 What User Qualifier 60 Empty, keep. User mark of conformity.
5 Other QRY Subject Filter 60 Empty, keep. Other QRF receive filter.
6 Which Date/Time Qualifier 12 Target type, take RCT.

Which Date/Time Status
7 Qualifier 12 Target status, take COR.
8 Date/Time Selection Qualifier 12 Date/Time Selection Qualifier, take ALL.

When Quantity/Timing
9 Qualifier 60 Empty, keep. Time interval segment.
Remark: This message segment presents in QRY^Q02. The 3rd and 4th segments are query zero point of the day
and query occurance time, which are used for querying time interval condition. All segments use character string
type.
8. DSP - display data segment
DSP segment used for displaying the queried sample information and test item, which can be duplicated. DSP shall
repeat 3 times, the 1st DSP segment is patient information, DSP uses the following fields at this time:
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User Manual

1 Set ID - DSP 4 Confirm different DSP segments.
The specific items are same as PID-2 to
2 - 31 PID-31 of PID segment Refer to PID explanation.
Remark: This segment only presents in DSR^Q03. The first segment uses integer data type. Other fields refer to
PID-2 to PID-31 explanation.
The second DSP segment is doctor’s advice information. DSP will use the following fields at this time:
1 Set ID - DSP 4 Confirm different DSP segments
The specific items are same as OBR-2and
2 - 47 OBR-47of OBR segment Refer to OBR explanation.
Remark: This segment only presents in DSR^Q03. The first segment uses integer data type. Other segments refer
to OBR-2 to OBR-47 explanation.
The third DSP is item information, refer to the following table for items and sequence:
1 Set ID - DSP 4 Confirm different DSP segment.
2 Item Count 4 Test item No.
Test item name. The items are separated by ^, such as
3 Items 1000 ALT^ALB^BUN, character string type.
Remark: This message segment presents in DSR^Q03. The 1st, 2nd segments use integer data type. Other
segments’ type are character string.
3. Communication Demonstration
3.1 Test Data Sending Procedure
Auto-chemistry analyzer transmits sample information and test results to LIS server in the unit of sample, namely
one sample information and its test results are transmitted together as one message. LIS server will give
corresponding response upon this message.
ORU message contains MSH, PID, OBR, OBX(There are many OBX segments if one sample contains many
items.).MSH is message head, which presents in all messages.
e.g. The following information of one patient:
Meaning Value
Patient Name Jack
Case No. 002
Gender Male
Send Date March 21st, 2011
Send Time 10:11:12(H/M/S)
Sample Barcode 12345
Sample Type Serum
Sample No. 10
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User Manual
Meaning Value
Emergency or not Yes
Sample Rack No., Position E002, 3
Age 2
Item No. 1,2,3
Item Name ALT,AST,BUN
Repeat Test Times 1,1,1
Test Result 2.3,35 ,2.1
Result Unit U/L,U/L,mol/L
Reference Range 0-40,0-34,2.82-8.2
The ORU^R01 message send to LIS is as follow:
LIS server will judge the validity and type and give corresponding response upon receiving the message. The
following is normal response:
If ORU message received by LIS server is incorrect, set corresponding code in MSA to back, analyzer software will
conduct corresponding processing. Such as, LIS server found 206 refuse error, its response ACK message is as
follow:
F-12
User Manual
Auto-chemistry analyzer transmits QC results to LIS server in the unit of one QC test. LIS server will give
corresponding response upon this message.
ORU message includes MSH, OBR.
The following information is of one QC test:
Meaning Value
Item No. 1
Item Name ALT
QC Name Randox Low Level
QC Lot No. 123
QC Times 1
Module No. 1
Sample Type Serum
Sample Rack, Position C001, 2
QC Mean 40
QC Standard Deviation 1
Tested Result(concentration) 123.232
Test Date/Time 2011.03.21 16:46:43
The ORU^R01 message send to LIS is as follow:
LIS server give corresponding response:
3.2 Send Query Request Procedure

Analyzer send query request to LIS server. And obtain corresponding sample information, patient information,
item information according to specified barcode.
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User Manual
Such as, download a sample with barcode 12345 from LIS server. Sample rack N003, position 4, no dilution, the
send QRY^Q02 message is as follow:
LIS server will return DSR^Q03 as response upon receiving this message. If there is corresponding sample, the
message is as follow:
If there is no corresponding sample, the return message is as follow:
If the QRY message received by LIS server is wrong, such as 206 refuse error presents, the return message is as
follow:
Analyzer will send ACK^Q03 as response upon receiving DSR message, the return message is as follow:
F-14
User Manual
Such as, download a sample with No.5 from LIS, sample rack N003, position 4, no dilution, the QRY^Q02 message
is as follow:
LIS return DSR^Q03 message as response upon receiving this message, the message for response is as follow:
Analyzer will send ACK^Q03 as response upon receiving DSR, the return message is as follow:
Remark: During query request sending, analyzer send sample rack, sample position, dilution information at QRD
of QRY^Q02 to LIS server. LIS server shall return the three segments according to original value from DSP of
DSR^Q03.
H-1
User Manual
Appendix H Performance indexes

H.1 stray light
Absorbance not less than 2.3.
H.2 Absorbance linear range
The max. absorbance shall not be less than 3.5 when the relative deviation is ±5.0%.
H.3 Absorbance accuracy (refer to Table H-3-1)
Table H-3-1 Absorbance Accuracy
Absorbance value Allowable error

0.5 ±0.025
1.0 ±0.07
H. 4 Absorbance stability
The change of absorbance shall not exceed 0.01.
H.5 Absorbance repeatability
It is expressed by coefficient of variation, and shall not exceed 1.5%.
H.6 Temperature accuracy and fluctuation
The temperature is within ±0.3℃ of the setting value, with a fluctuation not more than ±0. 1℃.
H.7 Sample carry-over rate
The sample carry-over rate shall not exceed 0. 05%.
H.8 Dispensing accuracy and repeatability
Test the dispensing volume of 2μL, 5μL and 300μL, the dispensing accuracy shall not exceed ±5.0%, and the
coefficient of variation (CV) shall not exceed 2.0%.
H.9 Within-run precision of clinical items
The coefficient of variation (CV) shall meet the requirements of Table H-9-1:
Table H-9-1 Requirements of Within-run Precision of Clinical Items
Item name Concentration range Variation coefficient

ALT (Alanine aminotransferase ) 30U/L～50 U/L ≤5.0%
UREA 7.0mmol/L～11.0mmol/L ≤2.5%
TP (total protein) 50.0g/L～70.0g/L ≤2.5%
H.10 Requirements on ISE performance (refer to Table H-10-1)

Table H-10-1 Requirements on ISE Performance Index
Linearity
Carry-over
Parameters Accuracy Precision Correlation Stability
Range Error rate
coefficient (r)
K+ ≤3.0% ≤1.5% 1.50-7.50 ≤3.0% ≤2.0% ≤1.5%
Na+ ≤3.0% ≤1.5% 100.0-180.0 ≤3.0% ≥0.995 ≤2.0% ≤1.5%
Cl- ≤3.0% ≤1.5% 80.0-160.0 ≤3.0% ≤2.0% ≤1.5%
H.11 Appearance and mechanical structure requirements

(1) The graphic symbols and words on the panel of the Analyzer should be accurate, clear, even and without
scratches;
(2) Connection of fastening parts should be reliable, without looseness;
(3) The moving parts should be stable, should not be stuck, should not jump or significantly empty, and the
H-2
User Manual
rebound of the key group should be flexible.

H.12 Environmental Test Requirements
The analyzer shall be tested in accordance with the requirements of Group I divided in terms of climate conditions,
the requirements of Group I divided in terms of mechanical environmental conditions, and the stipulations in Table
H-12-1.
Table H-12-1Environmental test requirements
Test Requirement Test Item

Test Item Test Recovery Power-on Test Middle
Duration Initial Test Final Test
Setting Time Status Condition Test
Rated work
Power on
low Whole Precision in
10℃ 1h － when －－
temperature performance H.5, H.10
testing
test
Low Power on
Precision in
temperature -40℃ 4h 24h after Benchmark －－
H.5, H.10
test testing
Rated work
Power on
high Precision in
30℃ 1h － when －－－
temperature H.5, H.10
testing
test
Power on
Operation Precision in
30℃ 4h － when －－－
test H.5, H.10
testing
High Power on
Precision in
temperature 55℃ 4h 6h after Benchmark －－
H.5, H.10
storage test testing
Rated work Power on
30℃, Precision in
humid heat 4h － when －－－
70%RH H.5, H.10
test testing
Power on
humid heat 40℃, Precision in
48h 24h after Benchmark －－
storage test 93%RH H.5, H.10
testing
Power on
Vibration One direction, normal work Precision in
after Benchmark －－
test position H.5, H.10
testing
Power on
Transport Whole
Normal package status after Benchmark －－
test performance
testing
H.13 Safety requirements

H.13.1 Electric safety should conform to IEC 61010-1:2010, IEC 61010-2-051:2015, IEC 61010-2-010:2014, IEC
61010-2-081:2015 and IEC 61010-2-101:2015 requirements.
H.13.2 Laser safety should conform to IEC 60825:2014 requirements.
H.14 Electromagnetic compatibility requirements: refer to Appendix J Statement on electromagnetic compatibility
H-3
User Manual
Appendix I Parts list

Parts List (including parts, accessories and consumables)
Replacement
Part name Position Replacing method Note
period
Halogen lamp Optical unit 2000 hours 10.4.3
ISE pinch valve tube Flow cell
(ISV3) assembly 3 months 10.5.5
ISE pinch valve tube Flow cell
3 months 10.5.5
(ISV4) assembly
6 months or
Flow cell
K electrode head 15000 10.5.4
assembly times
6 months or
Na electrode/reference Flow cell
15000 10.5.4
electrode assembly times
6 months or
Flow cell
CI electrode 15000 10.5.4
assembly times
This part can be
Peristaltic Please contact
ISE peristaltic pump tube 6 months checked/replaced by the
pump assembly customer service.
manufacturer/agency only.
Reaction disk It is regarded being used for 5
Cuvette mechanism 3 months 10.4.2 hours per day
Probe Appropriate
Probe assembly mechanism time 10.4.1
Stirring Appropriate
Mixing bar 10.4.5
mechanism time
This part can be
Refrigeration Appropriate Please contact
Peltier checked/replaced by the
unit time customer service.
Rinsing Appropriate
Rinsing probe 1 mechanism time 10.4.4
Rinsing Appropriate
Rinsing Appropriate
Rinsing Appropriate
This part can be
Syringe pump Appropriate Please contact
Rinsing of syringe pump checked/replaced by the
unit time customer service.
This part can be
Sample dispensing in Syringe pump Appropriate Please contact
checked/replaced by the
syringe pump unit time customer service.
This part can be
ISE dilution syringe Syringe pump Appropriate Please contact
checked/replaced by the
pump unit time customer service.
Flow cell Appropriate
ISE electrode seal ring assembly time 10.5.4
Rinsing Appropriate
Wiping block 10.4.4
mechanism time
Sample reagent Appropriate
Sample cuvette disk time
Probe unblocking tooling Appropriate
(optional) —— time —— Accompanying accessories
20mLreagent bottle —— Accompanying accessories
disk time
35mLreagent bottle disk time —— Accompanying accessories
70mLreagent bottle disk time —— Accompanying accessories
I-1
User Manual
Replacement
Part name Position Replacing method Note
period
MISPA CXL PRO Tube —— —— —— Accompanying accessories
38
MISPA CXL PRO Tube37 —— —— —— Accompanying accessories
MISPA CXL PRO Tube27 —— —— —— Accompanying accessories
Appropriate
Fuse —— time —— Accompanying accessories
Appropriate
Needle —— —— Accompanying accessories
time
Universal/10A/220V\soft Appropriate
power cord —— time —— Accompanying accessories
S6500-GY\UTP network Appropriate
—— —— Accompanying accessories
cable\5M\network cable time
I-2
User Manual
Appendix J Statement on electromagnetic compatibility

Requirements of electromagnetic compatibility: It shall comply with IEC 61326-1 and IEC 61326-2-6. See Table J-
1 for requirements on electromagnetic compatibility immunity and Table J-2 for requirements on emission test
items.
Table J-1 Requirements of Electromagnetic Compatibility and Immunity Test
Standard requirements
EMC basic Applicable Performance

Port Test item Test value
standard or not criterion
Electrostatic
Air discharge: 2kV, 4kV, 8kV
Discharges IEC 61000-4-2 Applicable B
Contact discharge: 2kV, 4kV
(ESD)
Radiated
3V/m,80MHz~2.0GHz
Case electromagnetic IEC 61000-4-3 Applicable A
80% AM
field
Rated
power-frequency IEC 61000-4-8 3A/m ,50Hz/60Hz Applicable A
magnetic field
0% for 1 cycle; B
Voltage sag IEC 61000-4-11 40% for 5/6 cycles; Applicable B
70% for 25/30 cycles C
Voltage 5%, duration:
IEC 61000-4-11 Applicable C
interruption 250/300 cycles
AC
Power Pulse train IEC 61000-4-4 1kV(5/50ns,5kHz) Applicable B
supply
Line-to-ground: 2kV
Surge IEC 61000-4-5 Applicable B
Line-to-ground: 1kV
Radio-frequency 3V,150kHz~80MHz
IEC 61000-4-6 Applicable A
conduction 80% AM
Not
Pulse train IEC 61000-4-4 1kV(5/50ns,5kHz) --
applicable
DC
Line-to-ground: 2kV Not
Power Surge IEC 61000-4-5 --
Line-to-ground: 1kV applicable
supply
Radio-frequency 3V,150kHz~80MHz Not
IEC 61000-4-6 --
conduction 80% AM applicable
Not
Pulse train IEC 61000-4-4 0.5kV(5/50ns,5kHz) --
applicable
I/O Not
Surge IEC 61000-4-5 None --
Signal applicable
Radio-frequency 3V,150kHz~80MHz
IEC 61000-4-6 Applicable A
conduction 80% AM
Not
Pulse train IEC 61000-4-4 1kV(5/50ns,5kHz) --
applicable
I/O signal
Not
to main Surge IEC 61000-4-5 None --
applicable
power
Radio-frequency 3V,150kHz~80MHz Not
IEC 61000-4-6 --
conduction 80% AM applicable
J-1
User Manual
Table J-2 Emission Test Items & Requirements
EMC basic Applicable

Test Items Test value
standard (Yes/ No)
Pst value is not greater than 1.0; Plt value is not greater than
Voltage 0.65; duration for d(t) value exceeding 3.3% in voltage change
fluctuation and IEC 61000-3-3 period is no longer than 500ms; change of relative steady-state No
flicker voltage (dc) does not exceed 3.3%; and relative maximum
voltage change (dmax) does not exceed 6%.
Harmonic
It is 1.5 times of the limit value specified in Table 1 of IEC
current IEC 61000-3-2 No
61000-3-2.
emission
Electromagnetic It meets the requirements on limit value of Class A and Group I
IEC/CISPR 11 Yes
disturbance equipment in IEC/CISPR 11.
Statement on electromagnetic compatibility:

● The manufacturer is responsible for providing the consumer/user with the information of electromagnetic
compatibility of the equipment.
● The user is responsible for guaranteeing the environment for electromagnetic compatibility of the
equipment so that it can work normally.
● The equipment meets the specified requirements on emission and immunity in IEC 61326.
● The equipment is designed and tested according to Class A equipment in IEC/CISPR 11. In home
environment, the equipment may cause radio interference, thus preventive measures should be taken.
● It is recommended to evaluate electromagnetic environment before using the equipment.
● It is forbidden to use the equipment beside any source of intense radiation, or it may interfere with normal
operation of the equipment.
J-2
User Manual
Appendix K Processing method for software sleep

The Analyzer is driven by the upper computer through the serial port, and it may have blue screen under standby or
sleep state. To avoid this phenomenon, the standby and sleep functions are prohibited. The specific operating
procedure is as below:
Right click the desktop, and select "Personalize" from the pop-up dialog box as shown in the figure.
Fig. K-1
Enter the "Personalization" interface as shown in the figure.
Fig. K-2
Select "Screen Saver" in Fig. K-2 and enter the relating interface as shown in the figure.
K-1
User Manual
Fig. K-3
Click "Change power settings" and enter the power options interface as shown in the figure.
Fig. K-4
Click "Balanced (recommended) " and then "Change plan settings" as shown in the figure.
K-2
User Manual
Fig.K-5
Set "Turn off the display" to "Never". As shown below:
Fig. K-6
Click "Change advanced power settings" and enter the power advanced settings interface, then set the hard disk
time to "Never" as shown in the figure.
K-3
User Manual
Fig. K-7
Click [OK] and return to plan management setup interface or Fig. K-6, and click [Save changes], then the setting is
finished.
K-4
Statement
AGAPPE DIAGNOSTICS LTD. has the final explanation right.
AGAPPE DIAGNOSTICS LTD.is responsible for security, reliability and capability of MISPA CCXL.
Automated Clinical Chemistry Analyzer under following circumstance.
1) Installation, adjustment, improvement and repair are proceeded by AGAPPE company professionals
or professionals (Engineers of Business partners) trained by AGAPPE Team
2) Relevant electric equipment is qualified according to state norms.
3) User Manual should be obeyed when operating instrument.
No extra announcement if interface changed.
Any question, please contact agappe@agappe.in
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AUTO-CHEMISTRY ANALYZER

Global Access Point:-

Agappe Diagnostics Switzerland GmbH,

Corporate Office (Asia Pacific Office):-

Agappe Diagnostics Ltd,

Mail: info@agappeswiss.com | marketing@agappeswiss.com | service@agappeswiss.com

Date of Production: See the label.

Service Life: 7 years

Date of Compilation/ Revision: 04-2018.

● Local printer shall be used to print the reports and charts.

● Please do not use combustible goods around the Analyzer.

AGAPPE Company has the final interpretation right of the manual.

(2) Relevant electrical equipment complies with national standards.

(3) The Analyzer is operated according to the manual.

Chapter 1 Brief introduction ......................................................................................................... 1-1

1.3.2 System composition of the Analyzer ................................................................................................................................. 1-6

1.4 Structure and functions of the Analyzer ...................................................................................................... 1-6

1.4.2 Analyzing module ............................................................................................................................................................. 1-6

1.5 Symbols.......................................................................................................................................................... 1-13

1.7.2 Analysis flow chart ..........................................................................................................................................................1-16

1.7.3 Photometric characteristics...............................................................................................................................................1-16

Chapter 2 Installation of the Analyzer.......................................................................................... 2-1

2.1.2 Environmental requirements ............................................................................................................................................. 2-1

2.1.3 Power requirements ........................................................................................................................................................... 2-2

2.1.4 Requirements for pure water ............................................................................................................................................. 2-2

2.2 Unpacking. ...................................................................................................................................................... 2-2

2.2.2 Way of carrying ................................................................................................................................................................ 2-2

2.3 Installation process ......................................................................................................................................... 2-3

2.3.2 Power connection .............................................................................................................................................................. 2-7

2.3.3 Connection of peripheral equipment ................................................................................................................................. 2-7

2.3.4 Software installation and uninstallation............................................................................................................................. 2-7

2.3.5 Pure water filling ............................................................................................................................................................. 2-11

2.3.6 Discharge of waste liquid .................................................................................................................................................2-12

2.3.7 System login .....................................................................................................................................................................2-12

2.3.8 Commissioning of the Analyzer ...................................................................................................................................... 2-15

2.3.9 Test of clinical items ........................................................................................................................................................2-15

2.3.10 Training for medical personnel ..................................................................................................................................... 2-15

2.3.11 Fill-in of installation acceptance report ......................................................................................................................... 2-15

2.4 Barcode reader of the sample reagent disk ................................................................................................ 2-15

2.4.2 Requirements for sample container ................................................................................................................................. 2-15

2.4.3 Requirements of reagent bottle........................................................................................................................................ 2-16

2.4.4 Requirements for sample barcodes use ........................................................................................................................... 2-16

2.4.5 Requirements for reagent barcodes use ........................................................................................................................... 2-16

2.4.6 Requirements for pasting barcode labels ......................................................................................................................... 2-16

2.4.7 Use of barcode reader ......................................................................................................................................................2-17

2.4.8 Rule of reagent barcodes ..................................................................................................................................................2-17

Chapter 3 Software operation ....................................................................................................... 3-1

3.1.2 Keyboard function............................................................................................................................................................. 3-3

3.1.3 List of software function keys ........................................................................................................................................... 3-3

3.2 How to operate software ................................................................................................................................ 3-4

3.2.2 Key selection ..................................................................................................................................................................... 3-4

3.2.3 Window opening ............................................................................................................................................................... 3-5

3.2.4 Operation of list box and scroll bar ................................................................................................................................... 3-6

3.2.5 Operation of pull-down menu. .......................................................................................................................................... 3-6

3.2.6 Option button and check box............................................................................................................................................. 3-6

3.2.7 Grid table width adjustment .............................................................................................................................................. 3-7

Chapter 4 System management ..................................................................................................... 4-1

4.1.2 Hospital information ......................................................................................................................................................... 4-2

4.1.3 Other information .............................................................................................................................................................. 4-4

4.2 System log........................................................................................................................................................ 4-7

Chapter 5 System setting ................................................................................................................ 5-1

5.1.2 Modification of serum index ............................................................................................................................................. 5-2