Operator’s Manual

AS-480
Auto Chemistry Analyzer

Copyright © E-LAB Biological Science & Technology Co., Ltd. All rights reserved.
Version: V1.8 Issue Date: 2023.10
Preface
Thank you for purchasing the auto chemistry analyzer manufactured by our company.
This manual introduces safety and the correct use of auto chemistry analyzer, read it carefully
before use.

Product Name: Auto Chemistry Analyzer

Type/Model: AS-480
Scope of application: Quantitative analysis of clinical chemical components in serum, plasma,
urine, cerebrospinal fluid and other samples.
Manufacturer: E-LAB Biological Science & Technology Co., Ltd.
Address: Building 9, No. 1 Kechuang Road, Yaohua Street, Qixia District, Nanjing City, Jiangsu
Province, 210046, China
Customer Service Department: E-LAB Biological Science & Technology Co., Ltd.
Tel: +86-025-83269256 Fax: +86-025-83269255

Precautions in using this manual

⚫ Before using the auto chemistry analyzer, please read this manual thoroughly and
understand it for relevant operation instructions.
⚫ Without permission, can't copy and duplicate any manual chapters.
⚫ Please keep this manual properly for convenient use.

Whom and What this manual is for

This manual is written for clinical laboratory professionals, explain how to operate auto
chemistry analyzer.
⚫ Intended User
People who received professional training will available to read this user manual to learn more
information about analyzer. It is necessary to read it carefully before using.
⚫ Purpose
Help user to understand the performance of analyzer well and operate machine well.

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 Safety symbol marks used in this manual
Ensure to understand well of below signs, it is important to you!
When you see... Then…

This sign is warning you that a wrong operation will cause

Warning serious injury.

This sign is warning you that machine system was damaged or

Caution in an unreliable situation.

This sign warning you some important information that

Note requires your Note.

This sign warning you that will cause a potentially biohazardous

Biohazard condition.

Labels used on the System

The labels attached to the panels of the system use symbols to clarify the meaning of the text.
The list below shows the symbols that are used on the analyzer.
Symbol Meaning

Serial number

Biohazard Warning: risk of potentially biohazardous infection

︱ ON (main power)

○ OFF (main power)

~ Alternating current

In vitro diagnostic medical device

Date of manufacture

Manufacturer

Use by

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 Temperature limitation

Atmospheric limitation

Humidity limitation

Separate collection of electronic and electrical appliances

Authorized representative in the European Community

Warranty
⚫ Professional use only.
⚫ 1 year warranty since purchase date, except below conditions:
◆ Damage cause of natural calamities, such like flood, fire etc.
◆ Wrong operation.
◆ Consumables and accessories.
◆ Damage cause of customer open or repair machine without authorization.
◆ Damage cause of aspirating strong corrosive materials.
◆ Wrong operation cause software crash.

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iv
Contents
Preface .............................................................................................................................. i
Precautions in using this manual.................................................................................................... i
Whom and What this manual is for ............................................................................................... i
Safety symbol marks used in this manual ......................................................................................ii
Labels used on the System .............................................................................................................ii
Warranty .......................................................................................................................................iii

Contents ............................................................................................................................ I

1. Safety cautions and installation environments .......................................................... 1

1.1. Safety cautions .................................................................................................................. 1
1.2. Installations environments ................................................................................................ 4
1.2.1. Installation environment conditions ................................................................... 4
1.2.2. Environmental requirement ................................................................................ 5
1.2.3. Power Requirements ........................................................................................... 6
1.2.4. Liquid requirements ............................................................................................ 6

2. System description .................................................................................................... 7

2.1. Outline of functions ........................................................................................................... 7
2.2. Structure of instrument..................................................................................................... 7
2.2.1. Reagent disk ........................................................................................................ 7
2.2.2. Sample disk .......................................................................................................... 7
2.2.3. Reaction table...................................................................................................... 7
2.3. Technical parameters ........................................................................................................ 8

3. Installation................................................................................................................ 9
3.1. Unpacking .......................................................................................................................... 9
3.2. Connection ........................................................................................................................ 9

4. Software installation and uninstall .......................................................................... 10

4.1. Software installation environment conditions ................................................................ 10
4.1.1. Computer configuration requirements ............................................................. 10
4.1.2. Operation system requirements ....................................................................... 10
4.2. Software installation procedure ...................................................................................... 10
4.3. Software uninstall procedure .......................................................................................... 10
4.4. Data backup ..................................................................................................................... 11

5. Basic operation ....................................................................................................... 12

5.1. General operating procedure .......................................................................................... 12

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 5.2. Preparing for analysis ...................................................................................................... 13
5.2.1. Checking before powering on ........................................................................... 13
5.2.2. Set IP address .................................................................................................... 13
5.2.3. Powering on....................................................................................................... 13
5.2.4. Starting the operation software ........................................................................ 13
5.2.5. Setting up the analyzer ...................................................................................... 14
5.2.6. Preparing the reagents ...................................................................................... 14
5.2.7. Air purge ............................................................................................................ 14
5.3. Starting analysis............................................................................................................... 15
5.3.1. Programming Calibrators .................................................................................. 15
5.3.2. Programming QC ............................................................................................... 15
5.3.3. Programming routine samples .......................................................................... 15
5.3.4. Editing test results ............................................................................................. 16
5.3.5. Print test reports ............................................................................................... 16
5.4. Finishing analysis ............................................................................................................. 16
5.4.1. Powering off ...................................................................................................... 16
5.4.2. Checking ............................................................................................................ 16

6. Advanced operation ................................................................................................ 17

6.1. Reagent............................................................................................................................ 17
6.1.1. Reagent settings ................................................................................................ 17
6.1.2. Reagent status ................................................................................................... 23
6.2. Test .................................................................................................................................. 25
6.2.1. Sample register .................................................................................................. 25
6.2.2. LIS Obtain........................................................................................................... 27
6.2.3. Sample Results................................................................................................... 29
6.2.4. Test Result ......................................................................................................... 31
6.3. Calibration ....................................................................................................................... 32
6.3.1. Calibration register ............................................................................................ 32
6.3.2. Calibration Results ............................................................................................. 33
6.4. QC .................................................................................................................................... 34
6.4.1. QC register ......................................................................................................... 34
6.4.2. Daily QC ............................................................................................................. 35
6.4.3. Day to Day QC .................................................................................................... 37
6.4.4. QC Summary ...................................................................................................... 38
6.4.5. QC Setting .......................................................................................................... 39
6.5. Maintenance.................................................................................................................... 40
6.5.1. Maintenance...................................................................................................... 40

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 6.5.2. Maintenance log ................................................................................................ 42
6.6. System setting ................................................................................................................. 43
6.6.1. Profile setting .................................................................................................... 43
6.6.2. Calculated test ................................................................................................... 44
6.6.3. Print Test ........................................................................................................... 45
6.6.4. Dictionary .......................................................................................................... 46
6.6.5. Special Wash...................................................................................................... 47
6.6.6. User Setting ....................................................................................................... 48
6.6.7. Report format .................................................................................................... 49
6.6.8. Test order .......................................................................................................... 50
6.6.9. LIS ...................................................................................................................... 51
6.7. Start condition ................................................................................................................. 52
6.8. Sample Stop and Stop ..................................................................................................... 53
6.9. Status ............................................................................................................................... 54
6.9.1. Sample status .................................................................................................... 54
6.9.2. Reagent status ................................................................................................... 56
6.9.3. Reaction status .................................................................................................. 57
6.9.4. Cell Bank Status ................................................................................................. 58
6.10. Alarm ............................................................................................................................... 59
6.11. Shut down........................................................................................................................ 60
6.12. Log off .............................................................................................................................. 60
6.13. About ............................................................................................................................... 61

7. Service and maintenance ........................................................................................ 62

7.1. Executing Air purge ......................................................................................................... 62
7.2. Checking Syringe.............................................................................................................. 62
7.3. Sample probe and reagent probe ................................................................................... 63
7.4. Reaction table.................................................................................................................. 64
7.5. The mixing bar ................................................................................................................. 64
7.6. Reagent and sample tank ................................................................................................ 65
7.7. Instrument surface .......................................................................................................... 65

8. Troubleshooting ...................................................................................................... 66
8.1. The fault phenomenon and treatment ........................................................................... 67
8.2. Component replacement ................................................................................................ 68
9. Replace lamp ..................................................................................................... 68
10. Replace probe.................................................................................................... 69
11. Replace reaction cuvette ................................................................................... 69

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9. Appendix 1 Calculation Method .............................................................................. 70
9.1. 1 point end ...................................................................................................................... 70
9.2. 2 point end (Sample Blank) ............................................................................................. 71
9.3. Fixed-time ........................................................................................................................ 72
9.4. Kinetic .............................................................................................................................. 73

10. Appendix 2 Calibration type .................................................................................... 74

10.1. 1 point linear ................................................................................................................... 74
10.2. 2 point linear ................................................................................................................... 75
10.3. Multi point linear ............................................................................................................. 76
10.4. Line graph ........................................................................................................................ 77
10.5. Logit-Log 3P ..................................................................................................................... 78
10.6. Logit-Log 4P ..................................................................................................................... 79
10.7. Logit-Log 5P ..................................................................................................................... 80
10.8. Exponential ...................................................................................................................... 81
10.9. Spline ............................................................................................................................... 82

IV
1. Safety cautions and installation environments
1.1. Safety cautions
For safety and effective use, please obey the following conditions.
◼ Prevention of Breakage and Flammability

Warning
⚫ Analyzer must be installed in right place and good conditions refer to the
manual.
⚫ Analyzer has to be installed in an unsuitable environment, please contact
technical support first.
⚫ It is forbidden that removing any screws and fasteners on the rear panel of
machine during instrument normal operation.
⚫ Before operation, please close protective barrier and do not open the
protective barrier during operation.
⚫ Tool for removing instrument protective barrier and/or enclosure guarding,
which is kept by the equipment management department.
⚫ The analyzer must be used in the condition of good grounding, and should be
independent power supply, input voltage should be in accordance with the
requirements of the instrument.
⚫ Do not use wet hands to touch power, otherwise there is a risk of electric
shock.
⚫ Don't trample, twist, pull wires and cables, and if the wires and cables break
off the fire.
⚫ Before cutting off the total power supply equipment switch, non-professional
repair personnel do not open the back cover and side cover.
⚫ If there is a liquid into the instrument internal or internal pipe leakage,
please immediately close the total power supply, and promptly contact the
company's after-sales service personnel.
⚫ When the instrument works, do not touch the sample probe, reagent probe
and mixing rod and other moving parts. Do not hand into the open parts,
otherwise damage may cause physical injury or instrument.
⚫ When changing the light source, cut off the power supply, and wait for the
light source to cool down.
⚫ Should be strictly in accordance with the User's Manual for regular
maintenance and maintenance of the instrument, otherwise it may cause the
instrument malfunction or impact the accuracy and precision of the
instrument test.
⚫ To ensure that the use of the auto chemistry analyzer under the conditions
specified in the user manual; if the condition is not used, the instrument may

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 not run properly, the measurement results will be unreliable, and may
damage the instrument components or cause damage to the body.
⚫ Do not use combustible dangerous goods around the instrument.
⚫ In order to avoid the fault caused by the moving the auto chemistry analyzer,
please contact our customer service department.
⚫ Please use the equipment in a manner specified by the manufacturer, or the
protection provided by the equipment may be impaired.
⚫ Please use mains power cord only provided by manufacturer. It is not
allowed to use mains supply cord with inadequate rating.

◼ Preventing infection

Biohazard
⚫ Inappropriately handling test solution, waste solution may lead to
biohazardous infection. Do not touch the test solution, waste solution with
your hands. Wear gloves and lab coat, and goggles if necessary.
⚫ In case your skin contacts the test solution or waste solution, follow standard
laboratory safety procedure and consult a doctor.
⚫ Discarded or faulted medical devices in accordance with local regulations
require the first disinfection, and then harmless treatment.

◼ Preventing Personal Injury Caused by Lamp house

Warning
⚫ Light sent by the lamp house may hurt your eyes. Do not stare into the lamp
when the system is in operation.
⚫ If you want to replace the lamp, first switch off the MAIN POWER and then
wait at least 15 minutes for the lamp to cool down before touching it. Do not
touch the lamp before it cools down, or you may get burned.

◼ Precautions on use
For getting best test results, please obey the following conditions.

Note
⚫ Please don’t shaking or touch machine when it is working; otherwise will
influence test result.
⚫ Quality control is necessary to use for checking machine in good work
condition or not.
⚫ Daily maintenance is very important. Unstable test results and short service

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 life most cause of carelessness.
⚫ Process calibrator, controls and reagent please refer to their instruction.
⚫ Volume of sample and reagent, corrected value of wavelength and
incubation time must accord with the instruction of reagent kits, calibrator
kits or control kits.
⚫ Any doubts of operation, please read user manual first.
⚫ The samples cannot be mixed with fibrin, impurities and other insoluble
substances.

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1.2. Installations environments

Caution
Make sure the instrument is installed in a place meeting the following
requirements. Otherwise, it will not perform as promised.
1.2.1. Installation environment conditions
⚫ The instrument is for indoor use only.
⚫ The bearing platform should be level (gradient less than 1/200).
⚫ The carrying capacity of the bearing platform should be more than 300 kg.
⚫ The bearing platform should be free of shaking.
⚫ The installation site should be well ventilated.

Caution
The instrument radiates heat while operating. A well ventilated environment helps
keep the room temperature stable. Use ventilation equipment if necessary.
⚫ The installation site should be free of dust as much as possible.
⚫ The installation site should not be in direct sun.
⚫ The site should not be near a heat or draft source.
⚫ The installation site should be free of corrosive gas and flammable gas.
⚫ The site should not be disturbed by large noise or power supply.
⚫ The instrument should not be placed near brush-type motors and electrical contacts that
are frequently turned on and off.
⚫ Do not use such devices as mobile phones or radio transmitters near the instrument.
Electromagnetic waves generated by those devices may interfere with operation of the
instrument.
⚫ The altitude height of the installation site should be lower than 2000 meters.

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 Instrument setting diagram

power power power

socket socket socket
DI

More than 50cm

Waste Waste
water
bucket bucket
bucket
LAN line
More than 50cm Waste DIwater
USB line pipe pipe
less less
than 2m than 2m

H L DI
waste waste Water

Auto Chemistry Analyzer

765mm

1100mm

Caution
The equipment connected to the analyzer interfaces, e.g. computer, must be
complied with the requirement of current edition of IEC 60950-1 or EN 60950-1.

Caution
Auto chemistry analyzer and computer, printer cannot be connected in the same
power socket.

1.2.2. Environmental requirement

Working environment requirements

⚫ Temperature limitation: 10℃~30℃.
⚫ Humidity limitation: 30%RH - 80%RH, without condensation.
⚫ Atmospheric limitation: 86KPa~106 KPa.

Caution
Operating the instrument in an environment other than the specified may lead
to unreliable test results.
If the temperature or relative humidity does not meet the above-mentioned
requirements, be sure to use air-conditioning equipment.

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 Storage and transportation environmental requirements
⚫ Temperature limitation: 0℃~40℃.
⚫ Humidity limitation: 30%RH - 80%RH, without condensation.
⚫ Atmospheric limitation: 86KPa~106 KPa.

1.2.3. Power Requirements

⚫ Power supply: AC 220V, 50Hz;
AC 110V,50/60Hz.
⚫ Power: 500VA.
⚫ The distance between the power socket and the system should be less than 2.5 meters.

Warning
To avoid the risk of electric shock, this equipment must only be connected to
supply mains with protective earth.

Warning
Mains plug or appliance coupler is intended to be used as isolation device from
the supply mains. Please always make mains plug or appliance coupler easily to
operate.

1.2.4. Liquid requirements

Distilled water: electrical conductivity less than 1us/cm.

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2. System description
2.1. Outline of functions
The instrument is auto chemistry analyzer for in vitro diagnostic use in clinical laboratories and
designed for in vitro quantitative determination of clinical chemistries in serum, plasma, urine
or cerebrospinal fluid samples.

Caution
Some samples may not be analyzed on the instrument based on parameters the
reagents claim capable of testing. Consult the reagent manufacturer or distributor
for details.

2.2. Structure of instrument

2.2.1. Reagent disk
Reagent container: outer ring 30ml, inner ring 70ml;
Reagent disk: 90 reagent position;
Reagent refrigerating system can keep cool about 8℃ when room temperature is 25℃ for 24
hours

2.2.2. Sample disk

The sample disk is divided into three circles, 40 per circles and a total of 120 sample position.

2.2.3. Reaction table

The reaction table is single circle, with a total of 90 semi-permanent plastic cuvettes, light path
6mm;
Reaction volume: 150ul~330ul;
Automatic cleaning of reaction cuvette: automatic cleaning and drying of reaction cuvette at
the end of each test for next using.
Reaction table temperature: 37±0.1℃

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2.3. Technical parameters
Machine type: Random access, open reagent & locked reagent (optional)
Test speed: Constant 400 tests/hour (mono reagent or double reagent)
Test principle: Colorimetric method, turbidimetry
Test method: 1 point end, 2 point end, Fixed-Time, Kinetics
Calibration type: Linear & nonlinear
Sample cup type: Micro cup & test tube
Sample volume: 2-30ul, step by 0.1ul
Reagent volume: 20-300ul, step by 1ul
Reaction volume: 150ul-330ul
Reaction time: 10 minutes
Temperature: Peltier pad incubation system, reaction temperature (37℃±0.1 ℃)
Cuvette washing: 2*6 steps automatic washing
Size (length*width*height): 1100mm*765mm*1150mm
Chemistry analyzer net weight: 200Kg
Sound level: ≤40dB
Absorbance accuracy: 0.5±0.025, 1.0±0.07
Absorbance stability: ≤0.01
Absorbance repeatability: ≤1.5%
Clinical batch precision: ALT≤3%, Urea≤2.5%, TP≤2%

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3. Installation
The system should be installed by our authorized personal only, and you should prepare a
proper site for installation.

3.1. Unpacking
When you receive the system, carefully inspect the package.
If you see any signs of mishandling or damage, contact our Customer Service Department or
your local distributor immediately.
After opening the package, check the delivered goods against the packing list as well as the
appearance of the system.
If you find anything missing or damaged, contact our Customer Service Department or your
local distributor immediately.

3.2. Connection
⚫ Connect power cable from analyzer right side to power socket.
⚫ Connect LAN cable from analyzer back side to operation computer LAN port.
⚫ Connect DI water tube to DI water bucket.
⚫ Connect H waste tube to waste bucket or direct to Drain Facilities.
⚫ Connect L waste tube to waste bucket or direct to Drain Facilities.
⚫ Connect DI water liquid sensor form DI water bucket to analyzer back side if necessary.
⚫ Connect Waster liquid sensor form waster bucket to analyzer back side if necessary.

Caution
⚫ To ensure that no foreign body in the joint is required before connecting line.
⚫ The waste pipe cannot be bent, otherwise it will cause poor drainage.
⚫ The water supply quality must meet the standard of μS/cm<1, and the average
flow rate is ≥20 L/H.
⚫ If water purification equipment is used, the pressure of the water supply source
must be within the range of 0~300KPa, and the length of the water inlet pipe
should be <10m.
⚫ The diameter of the discharge port is ≥50mm, the height of the discharge port is
≤100mm, and the length of the waste liquid pipe is ≤5m.

Biohazard
Waste liquid handled in accordance with the local law, cannot be directly
discharged.

Warning
Auto chemistry analyzer power supply line area shall not be less than 1 mm2

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4. Software installation and uninstall
4.1. Software installation environment conditions
4.1.1. Computer configuration requirements
CPU more than 2GHz;
Internal storage more than 4G;
Hard disk more than 500G;
Display more than 1024*768 pixels;
4.1.2. Operation system requirements
Win XP, Win 7, Win8, Win10 operation system. Please use the professional version or ultimate
version.

4.2. Software installation procedure

Insert CD with the machine into the computer CD-ROM;
Running “setup.exe”;
The installation is completed, connect console computer and analyzer with LAN line, then
running “BioAnalyzer 4AS” in desktop.

Note
Please refer to “Auto Chemistry Analyzer Software Installation Manual.doc” in the
software installation package for details.

4.3. Software uninstall procedure

Click "start" - "control panel" - "program" - right click "BioAnalyzer" - click "uninstall".
After the uninstall will display the following interface:

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 After the end of the scroll bar, uninstall successfully.

4.4. Data backup

Open the root directory of the analyzer software (default: D:/BioApp/App), copy "Bio.mdf" and
"Bio_1.ldf" database for backup. When you need to query the database data, you need to
backup the original database, and then copy the backup database to the new install root
directory of the “BioAnalyzer 4AS" software.

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5. Basic operation
5.1. General operating procedure

Checking before power on

Preparing for analysis

Powering on

Starting operation software

Setting up the analyzer

Preparing the reagents

Air purge

Programming Calibrators
Starting analysis

Programming QC

Programming routine samples

Editing test results

Print test reports

Powering off
Finishing analysis

Checking

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5.2. Preparing for analysis
5.2.1. Checking before powering on
You should do the following operations before starting the analyzer.
⚫ Check the power supply and make sure it can supply proper voltage for the analyzer.
⚫ Check the TCP/IP connections among the analyzing unit and computer. Make sure the
connections are right and secure.
⚫ Check the DI water bottle and liquid sensor connection well.
⚫ Check the waste tube and liquid sensor connection well.
⚫ Check the recycle liquid is sufficient.

5.2.2. Set IP address

You should set the console computer IP address as 192.168.2.123 before running software first
time.
⚫ Use “ip setting tool.exe” to set IP address automatically
⚫ Manually set IP address

Note
Please refer to “ip setting method of control computer.doc” in the software
installation package for details.

5.2.3. Powering on
Power on the analyzer in the sequence presented below:
⚫ Switch on the main power;
⚫ Switch on the Device power;
⚫ Switch on the Cooler power if necessary.

5.2.4. Starting the operation software

Start the Windows operating system. Then double click to start operating software
System checks the communication with the analyzer first. The connecting machine dialog box
of the operating software is displayed if communication check work is in progress. If you need
not to connect with the analyzer, you can click the Skip button.

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 ⚫ The Login dialog box of the operating software is displayed. Enter the username and
password, and then select Login.

5.2.5. Setting up the analyzer

The analyzer will not function properly unless it is properly set up.
You must complete all the following settings if this is the first time the analyzer being used.
Before requesting the tests, you must finish the following settings:
⚫ Reagent settings: Select Reagent→ Reagent settings, and enter test parameters following
the reagent package insert. Refer 6.1.1 Reagent settings for details.
⚫ Reagent status: Select Reagent→ Reagent status, and set up the reagent bottle
information. Refer 6.1.2 Reagent status for details.
⚫ QC settings: Select QC→QC Setting, and set up controls information. Refer 6.4.5 QC Setting
for details.
⚫ System settings: Select System, and set up profile, calculated test, Print Test, Dictionary,
User, Report format, Test Order and LIS. Refer 6.6 System setting for details.
5.2.6. Preparing the reagents
Load reagent bottles to their assigned positions on the reagent disk, and then open the
bottles.

5.2.7. Air purge

Execute “Air purge” in maintenance window when you do analysis first time.
Air bubbles come into dispensing tube, Execute Air purge to get rid of those air bubbles. The
flow path is filled with new water. Refer 6.5Maintenance for details.

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5.3. Starting analysis
5.3.1. Programming Calibrators
When using the system for the first time, you must run calibrations following these steps:
⚫ Select Calibration→ Calibration register and register calibration for desired tests. Refer to
6.3.1 Calibration register for details.
⚫ After registering calibrations, you should load corresponding calibrators to their assigned
positions on the sample disk.
⚫ Select the Start Cond. to start running the calibrators. Refer to 6.7 Start Cond. for details
⚫ To view calibration results. Select Calibration→ Calibration results and select a test from
the list. Refer to 6.3.2 Calibration results for details.
5.3.2. Programming QC
It is recommended to run quality controls for each test every day and check if the system is
running normally and steadily.
⚫ Select QC→QC register and register QC for desired tests. Refer to 6.4.1QC register for
details.
⚫ After registering QC, you should load corresponding QC to their assigned positions on the
sample disk.
⚫ Select the Start Cond. to start running the calibrators. Refer to 6.7StartCond.for details
⚫ To view daily QC. Select QC→Daily QC and select a test from the list. Refer to 6.4.2 Daily QC
for details.
⚫ To view day to day QC. Select QC→Day to Day QC and select a test from the list. Refer to
6.4.3 Day to Day QC for details.
⚫ To view QC summary information. Select QC→QC Summary and select a test from the list.
Refer to 6.4.4 QC Summary for details.

Warning: Rated opening and closing

Exposure to the risk of injury
The instrument must be built on the cover. If you want to open the cover,
please wait for the instrument to stop the movement.

Caution
The samples cannot be mixed with fibrin, impurities and other insoluble
substances

5.3.3. Programming routine samples

Follow this procedure to analyze routine samples:
⚫ Select Test→sample register and register samples for desired tests. Refer to
6.2.1Sample register for details.

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 ⚫ After registering sample, you should load corresponding sample to their assigned positions
on the sample disk.
⚫ Select the Start Cond. to start running the samples. Refer to 6.7 Start Cond. for details
⚫ To view sample results. Select Test → Sample results and select a sample from the list.
Refer to 6.2.2 Sample results for details.
5.3.4. Editing test results
When analysis is finished, you can edit the test results if needed
To edit results of one or more sample runs, you can select Test → Sample results. Then select
the Sample NO. which you want to edit and the Edit Sample button to edit desired test result
on the popup dialog box. Refer to 6.2.2 sample results for details.

5.3.5. Print test reports

Select Test → Sample results then select desired test results and click the Print button. Refer
to 6.2.2 sample results for details.

5.4. Finishing analysis

5.4.1. Powering off
When all analysis is finished, the system is in standby status.
After exiting the Windows operating system, switch off the Device power.
The refrigerator still functions after switching off the Device power. To shut down the
refrigerator, switch off the cooler power and main power.

5.4.2. Checking
If the MAIN POWER is placed to OFF, take the reagents from the reagent disk and put them
into an external refrigerator
Remove the calibrators, controls and samples from the sample disk.
Check the surface of the analyzing unit for stains and wipe them off with clean soft cloth, if
any.
Check the waste bucket and empty it if necessary.

16
6. Advanced operation
6.1. Reagent
6.1.1. Reagent settings

This screen allows you to set an assay code, photometric point, measuring wavelength,
sample volume and reagent volume and other chemistry parameters.
You can edit the test configuration which you have set or add a new reagent test in this
screen.
⚫ Add: Click this button to add a new reagent test.
⚫ Save: Click this button to save the configuration after adding or updating the reagent
parameters setting.
⚫ Delete: Delete the test you have set.
⚫ Test name: Input a photometric test name to be used for screen display within 7
characters.
⚫ Full name: Input full name for printout in report format. It can be void.
⚫ Wavelength: Select a primary wavelength in the left box and a secondary wavelength in
the right box.
For single-wavelength photometry, select “None” in the Secondary wavelength list box.
⚫ Assay/Point: Select an assay mode (1point end, 2point end, Fixed-time, Kinetic); then Input
photometric points. Test cycle is 9 seconds, but the data is collected once every two test
cycles, and the number of cycles is 33.

17
 For the 1 point end method, the point refers to the end of the reaction. Only the end points
need to be inputted.
For the 2 point end method, the start point refers to the R1 and sample mixture. The end
point refers to the end of the reaction.
For the Kinetic or Fixed-time method, the start and end point refers to the interval between
the points when the reaction becomes stabilized.
When entering the reaction time in period, please refer to the following reaction procedure.

Reaction
R1&S R2
finised

P1 P10 P33

3 minutes 7 minutes

For more details about assay and point setup, please refer to Test Method explanation.

⚫ Decimal Place: Select the number of decimal place of test result (0,1,2,3,4).
⚫ Unit: Select or input the test result unit.
⚫ Linearity range: Input linearity range of test result.
⚫ Correlation factor: Input instrument factors (A: gradient, B: intercept) for correcting the
result of the measurement.
⚫ Sample volume:
Sample Vol.: It refers to the sample volume to be dispended for the reaction. It ranges
from 2 to 30ul.
◼ When automatic sample dilution function is used:
Left box: Select the sample dilution ratio.
Sam. Vol for dilution: It refers to the volume of the sample to be aspirated when auto
diluting. It ranges from 2 to 30ul.
Dilu. Vol. : Input a dilution volume when dilution ratio is selected as Custom.
The total volume of liquid must be brought to 150ul or more due to stirring.
⚫ Reagent:
◼ Volume: For R1 and R2, input a reagent volume. After addition of R1, R2 is added in about
3minutes.
Input a reagent volume in a range of 20 to 300ul. Input “0” when reagent pipetting is not
desired. The minimum volume that allows absorbance measurement is 150ul.
◼ Barcode: Input the code number of the reagent bottle. For the reagent bottle without
barcode, the bottle code need not be input.
⚫ Auto Checkup Rerun

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Substrate Depleted:
○1 combox: Input the percentage of substrate depleted.
○2 combox: It refers to the dilution ratio to the dilute the sample when auto rerunning.
Sam. Vol. for dilution: It refers to the volume of the sample to be aspirated when auto
rerunning. It ranges from 2 to 30ul.
Dilu. Vol. : Input a dilution volume when dilution ratio is selected as Custom.
Unselected the check box means that the check is not performed.
The substrate depleted limit range is anywhere from 0% to 100%, and the default is 50%.

Linearity:
○1 combox: Input the percentage of Linearity.
○2 combox: It refers to the dilution ratio to the dilute the sample when auto rerunning.
Sam. Vol. for dilution: It refers to the volume of the sample to be aspirated when auto
rerunning. It ranges from 2 to 30ul.
Dilu. Vol. : Input a dilution volume when dilution ratio is selected as Custom.
Unselected the check box means that the check is not performed.
The linearity limit range is anywhere from 0% to 50%, and the default is 1%.

Out of Linearity Range:

○2 combox: It refers to the dilution ratio to the dilute the sample when auto rerunning.
Sam. Vol. for dilution: It refers to the volume of the sample to be aspirated when auto
rerunning. It ranges from 2 to 30ul.
Dilu. Vol. : Input a dilution volume when dilution ratio is selected as Custom.
Unselected the check box means that the check is not performed.

Check rules:
The curve of substrate depleted is as follows:

① Normal sample
Abs
② High sample

①
Substrate Depletion Limit（%）=Abs ((A - B)/A) * 100

A
A:Slope of the starting detection section
B:Slope of the finishing reaction section
C:Slope of the whole reaction process of the
normal sample

B
C

Detection Time(s)
Finishing point
starting point

19
 Substrate Depleted: The double reagent test is checked starting with the addition of R2,
the single reagent test is checked starting with the addition of the R1+S.
The slope of the starting check (slope of 3 first point) is defined as A and the slope of 3 last
point is defined as B. The substrate depletion limit(%) = Abs ((A - B)/A) * 100.
If the substrate depletion limits of the reaction exceed predestined limit, the test substrate
is depleted in advance. If substrate depleted is enabled, the alarm (SUBDE) is attached to
the result. If substrate depleted is enabled and the automatic rerun dilution ratio for
substrate depletion is set, the automatic rerunning is triggered at the same time that the
alarm (SUBDE) is attached to the sample result.

Linearity: 1, The absolute value of the ratio that the slope coefficient A of the starting
section minus slope coefficient B of the finishing reaction section to the slope C of the
whole reaction process, which is the linearity limit of the test. The linearity limit (%) =
Abs((A-B)/C)* 100.
If the linearity limits of the reaction exceed predestined limit, the test has exceeded
linearity limits. If linearity is enabled, the alarm (LINE) is attached to the result. If linearity is
enabled and the automatic rerun dilution ratio for linearity is set, the automatic rerunning
is triggered at the same time that the alarm (LINE) is attached to the sample result.
2, If the overall absorbance points in whole reaction process are more than 8, collecting 6
points at the beginning section and the finishing section of reaction. If the overall
absorbance points in whole reaction process are between 4 and 8, collecting 3 points at
the beginning and finishing section of reaction. N represents the number of collecting
points.
3, Slope coefficient A of the beginning reaction section = Slope of the beginning reaction
section (the N-1 point from the starting point to the starting point) *N;
Slope coefficient B of the finishing reaction section = Slope of the finishing reaction section
(the N-1 point from the finishing point to the finishing point) *N;

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⚫ Test Name: Display the test name.
⚫ Calibration Name: Input a calibration name.
⚫ Calibration type: Select a calibration type.
⚫ Points: Input the number of standard solutions to be used for calibration (1 to 8)
⚫ K value: Input K value when calibration type is 1 point linear.
⚫ Blank Type: Select a water blank or reagent blank.
⚫ Concentration: Input concentration of standard solution. When preparing multiple dilution
lines with a single standard solution, input concentration after dilution.
⚫ Position: For point 0, select water blank or reagent blank. For point 1-7, select a position of
standard solution on sample disk.
⚫ Sample volume: Input a sample volume of standard solution. When diluting the standard
solution with the sample dilution function, input a sample volume before dilution.
⚫ Automatic: Select the sample dilution ratio.
⚫ Sam. Vol for: It refers to the volume of the sample to be aspirated when auto diluting. It
ranges from 2 to 30ul.
⚫ Diluent volume: Input a diluent volume when the standard solution is diluted with the
sample dilution function.
The total volume of sample and diluent must be brought to 150ul or more due to stirring.

21
 Input the test result range, if the final result is out of the range, it will be marked L or H in the
result list and report.
Reference Ranges: Set expected ranges in 3 age blocks each for male and female. Input an
upper limit of age (baby to 200) for application of the specific range, unit of age (Years,
Months or Days) and upper and lower limits of the specific range in this order from the left.
The specific range at the 3rd stage is applied to the age exceeding the input one at the 2nd
stage.
Default Age: set the default age for sample if its age is not input in Test windows ->Sample
results->Sample edit.
Default Sex: set the default sex for sample if its sex is not input in Test windows ->Sample
results->Sample edit.

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6.1.2. Reagent status

This screen allows you to set the reagent bottle information after Reagent settings, and then
load reagent bottles to their assigned positions on the reagent disk.
⚫ Display option: Choose a display order of below reagent list;
⚫ Empty: Display how many positions are idle of reagent disk;
⚫ Reagent information list: Information on the reagent bottle loaded in the reagent disk is
displayed.
◼ Position: The reagent bottle loading reagent disk number is displayed.
◼ Test name: The test name, diluent are displayed;
◼ Reagent Type: The reagent type (R1, R2), diluent, detergent are displayed;
◼ Available Tests: The number of available tests that has been calculated from the
remaining volumes of all the reagents to be used is displayed.
◼ Remaining Volume(UL):The remaining volume of reagent is displayed.
◼ Expire Date: The expire date of reagent is displayed.
◼ Barcode: The barcode of reagent bottle is displayed.
◼ Open Date: The open date of reagent is displayed.
⚫ Reagent Load button: Click this button to open the Reagent Load window.
In this window, you can load bottle information for a reagent bottle. Refer below for
details.
⚫ Barcode Scan button: Click this button to scan the reagent bottle.
⚫ Volume Check button: Click this button to open Reagent volume check windows. In this
window, you can check the reagent volume of the specified reagent bottle.
⚫ Delete button: Click this button to open the Delete window.
In this window, you can delete manually registered reagent bottle information.

23
 ⚫ Volume Refresh: Click this button to open Refresh windows. In this window, you can
refresh the reagent volume of the specified reagent bottle.

Follow this procedure to set the reagent information

⚫ Position: Select a position;
⚫ Open Date: Select a open date of reagent bottle.
⚫ Input method: Select the method of input reagent: With Barcode, Without Barcode.
⚫ Barcode: Input barcode of the reagent.
⚫ Test Name: Select a test name;
⚫ Reagent Type: Select the reagent type (R1, R2, Diluent, Detergent).
⚫ Bottle Size: Select the reagent bottle size (L, S).
⚫ Expiry date: Select a expiry date of reagent bottle.
⚫ Check button: Click this button to check whether the barcode is valid.
⚫ Save: Click this button to save configuration of reagent.
⚫ Return button: Click this button to return Reagent status window.

24
6.2. Test
6.2.1. Sample register

This window allows you to register tests for routine and emergency samples.
⚫ Sample information:
◼ Sample No.: Input a sample number, it is also the test sequence of samples except
emergency;
◼ Position: Select a position number on sample disk (1-120);
◼ Sample type: Select a sample type;
◼ Pre-dilution: If the sample has already diluted before register, select this check box
and input dilution factor in right box, the test result will multiply this factor
automatically;
◼ Sample ID: Input a sample ID number;
◼ Sample cup: Select a sample type (Standard Cup or Micro Cup). For use of a test tube,
select Standard Cup;
◼ Stat: Select the check box if the sample is emergency, and it has highest test priority;
◼ Register Date: Select the register date of the sample, the default is current operation
system date;
◼ Sample type: Select a sample type;
◼ Page select: Select test key pages 1 and 2.
⚫ Test keys:
Use these keys for test selection.
When a test key is selected, it is highlighted in blue.
The keys on the top to the fourth row are available as test keys.

25
 The bottom (fifth)row contains profile keys for grouped tests registered in the System
setting/Profile settings window.
Reagent mask: Indicates that automatic masking has been made such a condition as
insufficient remaining volume of reagent.
Calibration mask: Indicates that automatic masking has been made such a condition as
insufficient remaining volume of standard solution.
Mask: Indicates that masking is provided in the global menu/Start Condition window.
⚫ Work list: Display the registered sample after clicking register button.
S.No.: Display the sample number of registered sample after clicking register button.
Position: Display the position on sample disk of registered sample after clicking register
button.
Status: Display the status (Registered, New) of the sample.
⚫ Register button: Click this button to save test selection information, update the work list
and increment the sample number by one so that test selection can be made for the next
sample.
⚫ Cancel button: Click this button to cancel any modification of the window.
⚫ Delete button: Click this button to open Delete samples window. In this window, you can
delete samples has already registered.
⚫ Previous button: Click this button to display test selection information on the previous
sample.
⚫ Next button: Click this button to display test selection information on the next sample.
⚫ Batch button: Clicking this button opens the Batch Test Selection window.
To register the same test, sample type, sample cup, sample volume, for two or more
samples, select a test for the first sample for collective entry and click the OK button
instead of the Register button.
⚫ Lis Obtain: Click this button to open LIS Obtain window. When you set bidirection
communication mode in “System Setting”-> “LIS” window, you can obtain the sample test
results from LIS server.

26
6.2.2. LIS Obtain

Click Lis Obtain button to open LIS Obtain window. In this window, you can obtain sample
application information from LIS server through querying or scanning the sample barcode.
⚫ Display Option: Select a display option of sample: By sampleID, By SampleNo, By Position.
⚫ Latest Today: By selecting Latest Today, you can download latest sample information of
current day from LIS.
⚫ All of Today: By selecting All of Today, you can download all sample information of current
day from LIS.
⚫ Single Sample: When selecting Singe Sample, you should enter the bar code of the sample
that you want to download. Then the sample information will be downloaded to the
analyzer.
⚫ Query button: Click this button to send code to LIS server to obtain sample application
information.
After obtaining the sample application information from LIS server, the sample application
information will be displayed on the Sample Info table and Test Info table.
⚫ Sample Scan button: Click this button to open Sample Scan window. In this window, you
can scan sample barcode of the specified sample position.
⚫ Position: Select a sample position on the sample disk.
⚫ Set button: Click this button to set the sample position.
⚫ Auto Set button: After clicking this button, the analyzer automatically set the sample
position.
⚫ Delete button: Click this button to delete the selected sample information.
⚫ Register button: Click this button to add the sample test to Work List.

27
 Scan sample barcode function:
The following steps explains usage methods of sample barcode scan.
1. Set parameters regarding LIS communication in the System Setting interface to ensure
the successful connection between the analyzer software and LIS host.
2. Place samples with barcode label in the free position of the sample disk.
3. Click Sample Scan button in the LIS Obtain interface.

4. Select the sample scan option: Selected Position and All Position. If Selected Position is
selected, input the specified sample position range.
5. Click OK button, the analyzer starts scanning the sample barcode on the sample disk, and
obtains the corresponding sample application information from LIS server.
6. Click Register button, the sample information is registered to Work List for preparing
sample testing.

28
6.2.3. Sample Results

This screen allows you to check/edit the respective measurement results of routine samples,
view the reaction process, and print out the report.
⚫ Display option: Select a condition for listing.
◼ Current date: Only the Information on all samples registered on current day is
displayed.
◼ Lasted Week: Only the information on all samples registered on lasted week is
displayed.
◼ Search: Only the information on the sample specified in the Search window is
displayed.
⚫ Sample Record Count: The number of samples registered in the selected data source is
displayed.
⚫ Search button: Click this button to open Search sample window.
In this window, you can set a search condition for the sample to be displayed in the sample
list.
⚫ Edit Sample button: Click this button to open Edit sample window.
In this window, you can edit sample information.
⚫ Edit Result button: Click this button to open Edit result window.
In this window, you can edit measurement results.
⚫ Delete result/sample button: Click this button to open delete result window.
In this window, you can delete selected sample or result.
⚫ Reaction curve button: Click this button to open reaction curve window.
In this window, you can view reaction curve of selected sample tests.

29
 ⚫ Print button: Click this button to print one or more selected samples results
⚫ Send To LIS: Send the results of selected sample to LIS system.
⚫ Export: Export the results of selected sample to file in your installation directory.
⚫ Manual Rerun: Click this button to open rerun window.
In this window, you can rerun sample test manually.
⚫ Replace Result: Click this button to open Replace result window.
In this window, you can replace the sample results with the rerun results.

30
6.2.4. Test Result

This screen allows you to view the history test count and results of the sample, and calculate
the Mean, SD, CV value of the test results.
⚫ Register Date: Select the start and terminal register date that you prepare for searching.
The first date is the beginning date and the second is terminates.
⚫ Search: Click this button to query the sample test results which meet the registered date
condition.
⚫ History Record Count: The total number of history test record is displayed.
⚫ Test Record Count: The number of test record that meet the registered date condition is
displayed.
⚫ Calculate: Select the sample test result, then click this button to calculate the Mean, SD and
CV value.

31
6.3. Calibration
6.3.1. Calibration register

This window allows you to register calibration for reagent blank and full (reagent blank and all
standard solution).
⚫ Status:
Gray: The test has no calibration.
Green: The test only does reagent blank calibration.
Yellow: The test does calibration including blank and standard solution.
⚫ Test keys:
Click the test keys to select the calibration status, a manual switchover is made by clicking
test key, if define water blank in Reagent/Reagent settings window, there is no blank status
switchover.
⚫ OK button: Click this button to save the configuration.
⚫ Cancel button: Click this button to cancel any modification.

32
6.3.2. Calibration Results

This screen allows you to view the calibration results, the reaction curve of each standard
solution, and the calibration curve.
⚫ Calibration type: Display the selected test calibration type defined in Reagent/Reagent
settings window.
⚫ Blank type: Display the selected test blank type defined in Reagent/Reagent settings
window.
⚫ S1 Abs: Display the absorbency of reagent blank, if you selected water for Blank Type in
Reagent/Reagent settings window, here displays 0.
⚫ K value: Display the K value of standard curve.
⚫ A, B, C: Display the parameters of standard curve for non-linearity calibration.
⚫ Test date: Display the latest and effective calibration test date.
⚫ Reaction Curve button: Click this button to open reaction curve window.
In this window, you can view the reaction curve of each standard solution.
⚫ Calibration Trace: Click this button to open calibration trace window.
In this window, you can view the history calibration result.
⚫ Calibration curve: Display the Calibration curve after calibration.
⚫ Standard, Concentration, Abs, Position: Display each standard concentration, absorbency
and position on sample disk.

33
6.4. QC
6.4.1. QC register

This window allows you to register QC tests for QC

⚫ QC information:
◼ Sequence No.: Input a sequence number, it is also the test sequence of QC;
◼ Position: Select a position number on sample disk;
◼ Register date: Select the register date of the sample, the default is current operation
system date;
◼ Name-lot number: Select the QC name and lot number that prepare for testing.
◼ Page selected: Select test key pages 1 and 2.
⚫ Test keys: Use these keys for test selection.
When a test key is selected, it is highlighted in blue.
⚫ Register button: Click this button to save test selection information, update the work list
and increment the sequence number by one so that test selection can be made for the next
QC.
⚫ Cancel button: Click this button to cancel any modification of the window.
⚫ Delete button: Click this button to delete samples which has already registered.
⚫ Previous button: Click this button to display test selection information on the previous QC.
⚫ Next button: Click this button to display test selection information on the previous QC.

34
6.4.2. Daily QC

This screen allows you to query daily QC results, display QC information, and QC chart.
⚫ Choose Test：
◼ Sort: Select a sort way that you prepare for viewing QC data.
◼ Test: Select a test name that you prepare for querying.
◼ Date: Select a test date for the quality control results that you prepare for searching,
the default value is current operation system date.
⚫ Choose QC：
◼ QC Rule: Select a quality control rule.
◼ QC1(Name-Lot): Select the first quality control name that you prepare for searching.
◼ QC2(Name-Lot): Select the second quality control name that you prepare for
searching.
⚫ QC Data: Select this option to show QC data on the interface.
⚫ QC Chart: Select this option to show QC chart on the interface.
Only if you select the Test name and QC(Name-Lot), you can view QC chart.
⚫ QC Data：
◼ QC Name: Display the QC name.
◼ Lot Number: Display the QC lot number.
◼ Test Name: Display the test name.
◼ Target Value: Display the target value of selected QC that defined in QC/QC setting
window;
◼ SD Value: Display the SD value of selected QC that defined in QC/QC setting window;
◼ QC Range: Display the range of selected QC that defined in QC/QC setting window;
◼ Result: Display the quality control test result.
◼ Test Date: Display the quality control test date.

35
 ◼ State: Display the quality control state.
⚫ Statistics: Click this button to open QC Cumulative Information window.

In this window, you can view QC cumulative information and compare two different lot No.
QC results.
◼ Target Value: Display the target value of selected QC that defined in QC/QC setting
window;
◼ SD Value: Display the SD value of selected QC that defined in QC/QC setting window;
◼ Count: Display the counts of selected QC test.
◼ Mean: Display QC result mean value that automatic calculated;
◼ SD: Display QC result SD value that automatic calculated;
◼ CV(%): Display QC result CV(%) value that automatic calculated;
⚫ Delete: Click this button to delete the selected QC in the QC Data list.
⚫ Send to LIS: Click this button, send the selected QC data to LIS server.
⚫ Print: Click this button to open Print window for printing the current QC chart.
In this window, you can choose Print Preview or Print directly.
⚫ Reaction Curve: Click this button to open Reaction curve for checking the reaction curve of
QC test.

36
6.4.3. Day to Day QC

This dialog allows you to query day to day QC results, display QC information, and QC chart.
⚫ Choose Test：
◼ Sort: Select a sort way that you prepare for viewing QC data.
◼ Test: Select a test name that you prepare for querying.
◼ Date: Select the start and terminal date of the quality control result that you prepare
for searching.
The first date is the beginning date and the second is terminates.
⚫ Choose QC：
◼ QC Rule: Select a quality control rule.
◼ QC1(Name-Lot): Select the first quality control name that you prepare for searching.
◼ QC2(Name-Lot): Select the second quality control name that you prepare for
searching.
⚫ QC Data: Select this option to show QC data on the interface.
⚫ QC Chart: Select this option to show QC chart on the interface.
Only if you select the Test name and QC(Name-Lot), you can view QC chart.
⚫ Statistics: Click this button to open QC Cumulative Information window.
In this window, you can view QC cumulative information.
⚫ Send to LIS: Click this button, send the selected QC data to LIS server.
⚫ Delete: Click this button to delete the selected QC in the QC Data list.
⚫ Print: Click this button to open Print window for printing the current QC chart.
In this window, you can choose Print Preview or Print directly.
⚫ Reaction Curve: Click this button to open Reaction curve for checking the reaction curve of
QC test.

37
6.4.4. QC Summary

This screen allows you to query QC result and QC summary.

⚫ Choose Test：
◼ Sort: Select a sort way that you prepare for viewing QC results.
◼ QC(Name-Lot): Select the quality control solution that you prepare for searching.
◼ Date: Select the start and terminal date of the quality control result that you prepare
for searching.
The first date is the beginning date and the second is terminates.
◼ Test Name: Select a test name that you prepare for searching.
⚫ QC Result: Select this option to show specified QC test results of the specified QC solution
on the interface.
⚫ QC Summary: Select this option to show QC summary information of the specified QC
solution on the interface.
⚫ Add button: click this button to open Add QC Result window. In this window, you can add a
new QC result.
⚫ Delete: Click this button to delete the selected QC in the QC Result list.
⚫ Print: Click this button to open Print window for printing the current displayed QC results or
QC summary information.
In this window, you can choose Print Preview or Print directly.
⚫ Reaction Curve: click this button to open Reaction Curve window for checking the reaction
curve of QC test.

38
6.4.5. QC Setting

This screen allows you to setup QC information and QC test information. Setup the target and
SD value for QC results processing.
⚫ QC list: Display the QC information.
⚫ Test list: Display the QC test information.
⚫ Add QC button: Click this button to open Add QC window.
In this window, you can add a new QC with lot number to the QC list.
⚫ Edit QC button: Click this button to open Edit QC window.
In this window, you can edit the information of selected QC in the QC list.
⚫ Delete QC button: Click this button to delete the selected QC in the QC list.
⚫ Reset Test button: Click this button to reset the selected test in the test list.
⚫ Save button: Click this button to save modification.
⚫ Delete test button: Click this button to delete the selected test in the test list.

39
6.5. Maintenance
6.5.1. Maintenance

This page allows you to execute a maintenance item such as Air purge and wash cells, and to
set and execute a maintenance pipe. For addition, updating or deletion of a maintenance pipe.
⚫ Maintenance Item: A list of maintenance items is displayed.
For execution of a maintenance item, select it from the list and click the Perform button.
⚫ Perform button: Click this button to open the Perform Maintenance Item window.
In this window, you can execute the maintenance item selected from the Maintenance Item
list.
⚫ Maintenance Pipe: A list of registered maintenance pipe names is displayed.
For execution of a maintenance pipe, select it from the Maintenance Pipe list and click the
Perform button.
⚫ The Pipe Items: A list of maintenance items registered in the maintenance pipe selected
from the Maintenance Pipe list is displayed.
⚫ Add button: Click this button to open the Add Pipe window.
In this window, you can register the name and details of a maintenance pipe.
⚫ Update button: Click this button to open the Update Pipe window.
In this window, you can update the name and details of the maintenance pipe selected
from the Maintenance Pipe list.
⚫ Delete button: Click this button to delete the name and details of the maintenance pipe
selected from the Maintenance Pipe list.

40
⚫ Perform button: Click this button to open the Perform Maintenance Pipe window.
In this window, you can execute the maintenance pipe selected from the Maintenance Pipe
list.

Replacing lamp
After replacing new lamp, select the “replacing lamp” option in the Maintenance Item and
then click “Perform” button to open Replacing Lamp windows. In this window, you can view
the usage time of lamp and replace lamp.

⚫ Last Lamp: Display the start date and duration for the last lamp.
⚫ Current: Display the start date and duration for the current lamp.
⚫ Replace: After replacing lamp, click this button and the analyzer starts recording the usage
time of lamp.
⚫ Cancel: Click this button to cancel replacing lamp.

41
6.5.2. Maintenance log

This window allows you to view the maintenance log.

⚫ Maintenance Log list:
◼ Maintenance item name: Display Maintenance item name that has already done.
◼ Operator ID: Display the operator ID that executes maintenance.
◼ Comments: Display the comments that define in Maintenance/perform window.
◼ Date: Display the execute date.
⚫ Start date: select the start date prepare for searching.
⚫ End date: select the end date prepare for searching.
⚫ Searching button: Click this button to display the maintenance log within the date range.

42
6.6. System setting
6.6.1. Profile setting

This window allows you to register a group of tests in a test key to be used for test registration.
⚫ Profile list:
◼ Add button: Click this button to open Add profile window.
In this window, you can add a profile in the profile list.
◼ Edit button: Click this button to open Edit profile window.
In this window, you can edit the name of selected profile in the profile list.
◼ Delete button: Click this button to delete selected profile in the profile list.
⚫ Test list:
◼ Add button: Click this button to open Add test button.
In this window, you can specify tests to be registered in the profile selected in the profile
list.
◼ Delete button: Click this button to delete test selected in the test list.

43
6.6.2. Calculated test

This screen allows you to set a calculation formula for calculation from the result of
measurement with the instrument.
⚫ Calculate test information:
◼ Test name: Input the name of calculate test;
◼ Full name: Input full name for printout in report format. It can be void.
◼ Decimal Place: Select the number of decimal place of test result (0,1,2,3,4).
◼ Unit: Selected or Input the result unit
◼ Formula: Display the calculated formula. After click the Formula button to open the
Formula Calculator window and input a calculation formula.
⚫ Reference range: Input the result reference range. It is optional.
⚫ Add button: Click this button to prepare adding a new calculate test.
⚫ Save button: Click this button to save the configuration after adding or updating.
⚫ Cancel button: Click this button to cancel the modification of this window.
⚫ Formula button: Click this button to open Formula window. In this window, you can setup a
calculated formula for the test.
⚫ Delete button: Click this button to delete the selected calculated test.

44
6.6.3. Print Test

This window allows you to add additional print test and print them on the test report as
needed.
⚫ Print test information:
◼ Test Name: Input the name of print test;
◼ Full Name: Input full name for printout in report format. It can be void.
◼ Result Type: Select Quantitative or Qualitative.
◼ Decimal Place: Select the number of decimal place of test result (0,1,2,3,4).
◼ Unit: Selected or Input the result unit
⚫ Reference range: Input the result reference range. It is optional.
⚫ Add button: Click this button to prepare adding a new calculate test.
⚫ Save button: Click this button to save the configuration after adding or updating.
⚫ Cancel button: Click this button to cancel the modification of this window.
⚫ Delete button: Click this button to delete the selected calculated test.

45
6.6.4. Dictionary

This window allows you to setup the data list that can be selected in some other window.
⚫ Data group: Choose a data style in this group.
⚫ Add button: Click this button to prepare adding a new element. After clicking this button,
then input a new element such as a new unit and description (it can be void), then click
save button to add in the data list.
⚫ Delete button: Click this button to delete the selected data in the data list.
⚫ Save button: Click this button to save the configuration.
⚫ Cancel button: Click this button to cancel any modification.

46
6.6.5. Special Wash

This screen allows you to set a washing program for carry-over evasion of the reagent probe
and reaction cell.
⚫ Reagent Probe:
◼ From Test: Select the test which may give influence.
◼ From Type: Select the type of reagent which may give influence.
◼ To Test: Select the test which may receive influence.
◼ To Type: Select the type of reagent which may receive influence.
◼ Wash Vol.: Input the volume of detergent to be used for washing.
◼ Add: Click this button to add a new washing program for reagent probe.
◼ Save: Click this button to save the configuration.
◼ Cancel: Click this button to cancel any modification.
◼ Delete: Click this button to delete the carry-over evasion program selected in Reagent
Probe list.
⚫ Cell:
◼ Test: Select the test which may give influence.
◼ R1 Vol.: Input the volume of detergent to be pipetted into the reaction cuvette
through the R1 probe.
◼ R2 Vol.: Input the volume of detergent to be pipetted into the reaction cuvette
through the R2 probe.
◼ Add: Click this button to add a new washing program for reaction cell.
◼ Save: Click this button to save the configuration.
◼ Cancel: Click this button to cancel any modification.
◼ Delete: Click this button to delete the carry-over evasion program selected in Cell list.

47
6.6.6. User Setting

This window allows you administrate the operator of the software.

⚫ User information: Input user information after clicking add button.
◼ Operator: Input operator name.
◼ Password: Input password.
◼ Confirm password: Input password again.
◼ Level: Select the operator authority
⚫ Add button: Click this button to prepare add a new User.
⚫ Save button: Click this button to save the user in users list after inputting user information.
⚫ Delete button: Click this button to delete selected user in users list.
⚫ Cancel button: Click this button to cancel any modification
⚫ Edit: Click this button to modify password.

48
6.6.7. Report format

This screen allows you to set conditions for printout of the measurement result in report
format.
⚫ Print order: Display the print order in report.
⚫ Report title: Input a head of report, include first and second line of the head.
⚫ Report endnotes: Input endnotes of report.
⚫ Report format: selected print report format and automatic print calculated test or not.
⚫ Save button: Click this button to save configuration.
⚫ Cancel button: Click this button to cancel any modification.

49
6.6.8. Test order

This window allows you to set the test order to prevent carryover of different reagent. This
order is also the display order on the test keys.
Click “Up” or “Down” button to reorder.

50
6.6.9. LIS

This window allows you to setup the basic parameters of LIS.

This system sends the results to LIS by LAN lines or RS232 interface, and it exchange sample
data and result data with the LIS server by HL7 protocol. You can setup transfer mode
unidirection or bidireciton by TCP/IP or RS232 interface in this window.

51
6.7. Start condition

This window allows you to set analysis start conditions. When starting analysis, check the
analysis start conditions and then click the Start button.
⚫ Cuvette temperature: Display the real-time temperature of reaction cells.
⚫ DI water: Display the DI water status, normal or insufficient.
⚫ Waste Water: Display the waste water status, normal or full.
⚫ Detergent: Display the detergent status.
⚫ Total samples: Display total samples number of registered.
⚫ Blank tests: Display the blank tests number of registered.
⚫ Calibration tests: Display calibration tests number of registered.
⚫ Control tests: Display QC tests number of registered.
⚫ Routine tests: Display routine sample tests number of registered.

52
6.8. Sample Stop and Stop

: Click this button, the analyzer will stop sampling after confirmation, continue
testing. And you can continue sampling by click start condition button.

: Click this button, the analyzer will stop doing anything immediately after
confirmation.

53
6.9. Status
6.9.1. Sample status

This window allows you to view sample disk status in any time, and release the sample
position after finishing test. Click a position to display its information on the right.

⚫ Idle: The position is idle. Nothing is to be analyzed

⚫ Registered: The position has already registered by sample, calibrator or QC.
⚫ Analyzing: The position is being analyzed by sample, calibrator or QC.
⚫ Finished: The position has already finished test by sample, calibrator or QC.
⚫ Empty: The position is blank, Nothing is placed.
⚫ Routine: The position is placed by routine sample.
⚫ Emergent: The position is placed by emergency sample.
⚫ Control: The position is placed by QC.
⚫ Calibrator: The position is placed by calibrator.
⚫ Insufficient: The liquid is insufficient in this position.
If it is sample, system will mask all tests of this sample, and alarm in Alarm window.
If it is QC, system will mask all tests of this QC, and alarm in Alarm window.
If it is calibrator, system will mask all tests of this reagent, and alarm in Alarm window.
After filling liquid, clicking Refresh button, system will do those tests again.

54
⚫ Refresh button: Click this button to refresh the liquid volume after filling, system will
continue analyzing the tests.
⚫ Release button: Click this button to release the position, otherwise, it cannot be registered
by new sample, QC or calibrator.

55
6.9.2. Reagent status

This window allows you to view reagent disk status in any time. Click a position to display its
information on the right. Reagent number is 90.
⚫ Reaction status:
◼ Idle: The position is blank.
◼ Normal: The reagent is normal.
◼ Insufficient: The reagent is insufficient, and system will mask all tests of this reagent.
After filling reagent, clicking Refresh button, system will do it again.
⚫ Position: Display the selected position number.
⚫ Test name: Display the test name of selected position.
⚫ Reagent Type: Display the reagent type, R1, R2, Diluent or Detergent.
⚫ Avaliable Tests: Display the available tests of left reagent bottle that auto calculated.
⚫ Remaining Vol.(UL): Display the remaining volume of reagent bottle that auto calculated.
⚫ Expire Date: Display the expire date of reagent bottle.
⚫ Barcode: Display the barcode of reagent bottle.
⚫ Bottle Size: Display the size of reagent bottle.
⚫ Open Date: Display the open date of reagent bottle.
⚫ Volume Refresh: Click this button to refresh the reagent volume after filling, system will
continue analyzing the tests.

56
6.9.3. Reaction status

This window allows you to view reaction table status in any time. Click a position to display its
information on the right.
⚫ Temperature: Display the real-time temperature of reaction table.
⚫ Cell blank button: Click this button to open Cell blank window.
In this window, you can view selected cell blank that latest10 times
⚫ Position: Display the selected position number.
⚫ Sample ID: Display the selected sample ID.
⚫ Test name: Display the selected reaction test name.
⚫ Reaction status:
◼ Pending: The cell is washed and unoccupied.
◼ Idle: The cell is clean, cell bank checking passed.
◼ R1: Dispensing first reagent.
◼ R1+S: Dispensing sample.
◼ R1+S+R2: Dispensing second reagent.
◼ Finished: Measurement is finished with results calculated.
◼ Mean check error: The cell is abnormal because of mean check error. System will
abandon this cell in running statue.
◼ Abs. check error: The cell is abnormal because of Abs. check error. System will
abandon this cell in running statue.

57
6.9.4. Cell Bank Status

This window allows you to view all cells blank status in any time.
You can click refresh button to refresh cells blank status.

58
6.10. Alarm

If an alarm is caused by any trouble, this window displays the detailed explanation of the alarm
(alarm level, alarm name and occurrence time) and the cause and remedy for it. Close the
window after checking the details of the alarm and taking necessary measures.
⚫ Time: Select the start time and end time for searching.
⚫ Level: Select a level of instrument alarms that you prepare for searching: warning, S.STOP
(sampling stop), STOP (stop), All.
⚫ Alarm list: The following are displayed for each alarm.
◼ Level: Instrument alarms are classified into four levels; warning, S.STOP (sampling
stop),STOP (stop)
◼ Alarm: Display alarm name.
◼ Time: Display Occurrence time of alarm
⚫ Details: For the alarm selected in the alarm list, the detailed description and remedial
measures are displayed.
⚫ Return button: Click this button to close this window.

59
6.11. Shut down

Click “Shut down” button to execute shut down machine.

⚫ Wash Cells: Click this button to exit software after washing cells.
⚫ Shut Down: Click this button to shut down machine immediately.
⚫ Cancel: Click this button to discard shut down machine and exit the current window.

6.12. Log off

Click “Log off” button to open Confirm window, click “OK” to logout the current user, or click
“Cancel” to exit log off.

60
6.13. About

Click About button to display product name, software version, IP address, manufacturer
information ect.
Click Machine Info. to open Machine Info. window. When you open the software at the first
time, you have to input authorization key to activate the machine.

61
7. Service and maintenance

Warning
⚫ Before service and maintenance, you shall pull out mains plug from mains
ocket-outlet.

The following maintenance is operated by the operator.

Warning
⚫ Do not sprinkle water, reagents, cleaning liquid and other liquid on the
instrument's mechanical or electrical parts, so as not to cause damage to the
instrument.
⚫ In the course of the operation, please do not contact with the absorption
mechanism, application of sample and reagent mechanism, mixing mechanism,
reaction cuvette cleaning mechanism, otherwise there is a risk of infection or
injury.
⚫ In the maintenance work, the operator should take preventive measures, need to
take protective gloves, wear overalls. Otherwise it may be exposed to pollution,
pollution of the liquid and the infection, or contact with corrosive liquid and
damage the skin. If there is contamination or corrosive liquid accidentally
touching the body, immediately wash water and disinfection.

7.1. Executing Air purge

Execute Air purge in maintenance window. When you do analysis first time or the analyzer is
long time in standby, Air bubbles will come into dispensing tube, Execute Air purge to get rid of
those air bubbles, the flow path is filled with new water.

7.2. Checking Syringe

You will see the syringes on the bottom of analyzer. Check whether the syringe leaks. If leaks,
tighten the screw cap. If still leaks, please contact technical support. once time a week.

62
 Screw cap

7.3. Sample probe and reagent probe

In the inside and outside of the probe has been polluted, easy attachment serum, reagent,
water droplets, and needle is easy to plug, thus affecting the results of the test instrument.
Therefore need to regularly check and timely cleaning.
(1), 3 times daily automatic infusion.
(2), Cleaning the probe tip once a week
(a) Pull off plug from socket.
(b) After unloading the sample disk and reagent disk, the probe is transferred to the
sample plate and reagent plate.
(c) A cotton swab dipped in alcohol, and wipe the outer wall of the probe.
(d) A cotton swab dipped in pure water to wipe the outer wall of the probe.
(e) Once again, click on the maintenance of the reset button, the sample needle, reagent
needle automatically restored to the initial position.

Warning: Flammable

Alcohol is easy to burn, use must be very carefully, in the vicinity of

the instrument do not place more than 20ml.

Biohazard
Wear gloves when cleaning sample and reagent probe, such as skin contact to
sample and reagent probe, need to use alcohol wash immediately, follow standard
laboratory safety procedure and consult a doctor.

63
7.4. Reaction table
If the reaction cuvette is contaminated, it may cause the test results are not accurate. In
addition, the reaction cuvette after a long time of use will occur, so should be regularly
cleaned of the reaction cuvette, and check the cell blank, when the cell blank abnormal alarm,
should be promptly replaced reaction cuvette. once time a week.
(1), Cleaning of the reaction cuvette
In the maintenance menu, click "wash cells (All)".
(2), Executive cell blank
(a) Pull off plug from socket;
(b) In the maintenance menu, click the "cell blank";
(c) After cell blank abnormal alarm, washing reaction cuvette again, and then retest cell
blank, if also abnormal alarm after washing, should replace the reaction cuvette.
(3), Replacing the reaction cuvette
(a) Pull off plug from socket;
(b) Wear good gloves, remove the screws.
(c) Rotate the reaction table with hand, remove the reaction cuvette in sequence.
(d) Replacing the new reaction cuvette, note that the cuvette wall is not scratched.
(e) Turn on the power switch of the analyzer.
(f) In the maintenance menu, click the "cell blank" twice.

Caution
If an emergency stop occurs during the testing process, the reaction cuvette
should be cleaned by hand.

Caution
Absolutely not to use organic solvents (benzene, alcohol, etc.) to scrub or soak
the reaction cuvette.

7.5. The mixing bar

If the mixing bar is contaminated, it will cause cross contamination, which will affect the
accuracy and precision of the test results. So should be cleaned regularly. In addition, if the
mixing bar is bent, it should be replaced. Once a week.
(1), Use a sponge dipped in alcohol to wipe the mixing bar;
(2), Use a sponge dipped in pure water to wipe the mixing bar

Caution
Do not bend the mixing bar in the process of wiping.

64
 Warning: Flammable

Alcohol is easy to burn, use must be very carefully, in the vicinity

of the instrument do not place more than 20ml.

Biohazard
Wear gloves when cleaning the mixing bar, such as skin contact to sample and
reagent probe, need to use alcohol wash immediately, follow standard
laboratory safety procedure and consult a doctor.

7.6. Reagent and sample tank

Reagent and sample tank will be samples, reagents and dust pollution, so should be cleaned
once a month.
(1), Remove the reagent table and wipe the inside of the reagent with gauze.
(2), Remove the sample disk and wipe the inside of the sample with gauze.

7.7. Instrument surface

After the end of the day, use gauze dipped in alcohol wipe the surface of the instrument.

Warning: Flammable

Alcohol is easy to burn, use must be very carefully, in the vicinity of

the instrument do not place more than 20ml.

65
8. Troubleshooting
This chapter describes the various types of instruments that may occur, and analyze the causes
of failure and provide the appropriate processing method.

Biohazard
⚫ Inappropriately handling test solution, waste solution may lead to
biohazardous infection. Do not touch the test solution, waste solution with
your hands. Wear gloves and lab coat, and goggles if necessary.
⚫ In case your skin contacts the test solution or waste solution, follow standard
laboratory safety procedure and consult a doctor.

Caution
⚫ The basis for troubleshooting maintenance, must turn off the power, pull off
plug from socket. Under the condition of the starting state, there is a risk of
electric shock and damage to electrical components, must be completed by
the professional staff.
⚫ The instrument must use the power supply voltage, otherwise, damage
caused by the instrument of our company is not responsible.

Note
⚫ In case of failure analysis of samples, the analysis results may be incorrect. If
there is a failure in the process of sample analysis, we must analyze the
sample after the fault is eliminated.

Warning: Touch

Hand touched rotating fan will be injured.

Instrument MAIN POWER in the ON state, do not touch the
fan, if you want to clean the fan, please be sure to instrument
MAIN POWER in OFF state.

66
8.1. The fault phenomenon and treatment
The following operation is done by the operator.
Error phenomenon Probable causes→ Correction actions
Instrument doesn't work or 1. Socket loose or contact undesirable → Reconnect and
no lighting of the power fixed socket and the power cable.
indicator 2. Power cable loose or contact undesirable→ Reconnect
and fixed power cable.
Communication error 1. NET cable loose or contact undesirable→ Reconnect and
fixed net cable.
2. Strong electromagnetic interference→Re plug the net
port on operation computer side and restart operation
software.
Dispensing probe drop 1. Air bubble come into dispensing tube→Execute Air purge
water in maintenance window
Water overflow in washing 1. Waste bottle is full→Empty the water solution.
station 2. The waste tubing is bent or clogged→Rehandle the waste
tubing and ensure it is nether bent nor clogged.
Mean check error of 1. The cell is dirty→Execute Wash Cells in maintenance
reaction cell window.
2. There are too much scratch on cell surface→ Replace a
new reaction cell.
Abs. check error of reaction 1. The cell is dirty→Execute Wash Cells in maintenance
cell window
2. There are too much scratch on cell surface→ Replace a
new reaction cell.
Dispensing probe liquid 1. The ground connection of power socket is not well→
sensor is abnormal ensure the ground connection well.

67
8.2. Component replacement
The following operation is done by the supplier service staff.

Warning
Before service and maintenance, you shall pull out mains plug from mains
ocket-outlet.

9. Replace lamp
After the confirmation of the lamp is damaged or light lamp is used for two years, it is required
to be replaced, and the following steps are as follows:
⚫ Pull off plug from socket 1 minutes later;
⚫ Open the front panel of the instrument panel and the upper panel to find the lamp power
supply adapter and disconnect;

⚫ Screw the lamp with the tool and remove the lamp;

⚫ Put the new lamp into the lamp holder, with the tools to fix the lamp;
⚫ Connect the lamp power adapter;
⚫ Install the instrument front panel and front panel.

68
 Warning: Scald

Immediately touch the lamp glass will be burned

If you need to replace the lamp, please put the instrument
MAIN POWER in the OFF state, and after the lamp cooling.

10. Replace probe

When replace the sample&reagent probe, do it like the following the steps:
⚫ First open the lid on the probe;

⚫ Plug pins off the red and black;

⚫ Unscrew the screws of the fixed pin;
⚫ Remove the hose from the probe and remove the probe,;
⚫ Put on the new probe, set up the hose;
⚫ Tighten the screws of the fixed pin;
⚫ The plug pins of the socket is inserted into the red and black.
⚫ Cover the lid.

Warning: Infected·Touch

Contact with the filling mechanism, mixing mechanism,

cleaning mechanism of the risk of infection or injury.
Maintenance checks when the body is in a state of stop. Please
wear rubber gloves. If the sample and reagent are splashed on
the skin, rinse with water immediately and disinfect. If
necessary, please call the doctor.

11. Replace reaction cuvette

Reaction cuvette due to dirt contamination or wear, in the reaction cuvette blank detection, if
the continuous secondary reaction cuvette blank absorbance alarm and after cleaning is still
not improve, it is recommended to replace the cuvette.

69
9. Appendix 1 Calculation Method
9.1. 1 point end
1 point end assay in which absorbance is measured at a designated photometric point (specific
time point when reaction reach balance) after addition of reagents. Below figure explains the
1point end assay.

Abs Double reagent

Abs Single reagent

R1＆ S R2
R1＆ S

E T E T

(a) Reagent setting screen input:

Assay/Point: input 1 Point end E
1<E≤33
(b) Calculation of absorbance:

AE + AE −1
AX =
2
(c) Calculation of concentration (Calibration type is linear):

C X = K  ( AX − B ) + C1  IFA + IFB

Cx: concentration of standby sample

C1: Concentration of standard 1 solution (reagent blank)
K: Factor
B: Absorbance of blank
IFA and IFB: Instrument constants, representing slope and intercept
(d) Analytical items
TP, ALB, etc.

70
9.2. 2 point end (Sample Blank)
2 point end assay in which measurement is made twice at different points to obtain the
difference in absorbance. One point is measured as the reaction initial, the other point is
measured when the reaction reach endpoint or balance. The difference between the
absorbance of two photometric points is used for calculation sample concentration. Below
figure explains the 2 point end assay:

Abs

R1＆ S R2

S E T

(a) Reagent setting screen input:

Assay/Point: input 2 Point end S E
1<S<10<E≤33
(b) Calculation of absorbance
The difference between the average of absorbance at measurement point E and E-1 and that
at measurement point S and S-1 is used.

AX = E
( A + AE −1 ) − k ( AS + AS −1 )
2
a
S +  Rj
j =1
k=
b
S +  Ri
i =1

a: No. of reagents at AS measurement

b: No. of reagents at AE measurement
(c) Calculation of concentration (Calibration type is linear):

C X = K  ( AX − B ) + C1  IFA + IFB

Cx: concentration of standby sample

C1: Concentration of standard 1 solution (reagent blank)
K: Factor
B: Absorbance of blank
IFA and IFB: Instrument constants, representing slope and intercept
(d) Analytical items
CRP, ASO, RF etc.

71
9.3. Fixed-time
Measurement is made twice at different measurement points (The two point are neither
measured initial nor endpoint) to determine the change in absorbance in order to calculate
sample concentration. Below figure explains the Fixed-time assay.

Abs Abs

R1＆ S R1＆ S R2

S E T S E T

(a) Reagent setting screen input:

Assay/Point: input Fixed-time S E
Single reagent:1<S<E≤33
Double reagent: 10<S<E≤33
(b) Calculation of absorbance:
The difference between the measurement point E and that at measurement point S

AX = AE − AS

(c) Calculation of concentration (Calibration type is linear):

C X = K  ( AX − B ) + C1  IFA + IFB

Cx: Concentration of standby sample

C1: Concentration of standard solution 1(reagent blank)
K: Factor
B: Absorbance of blank
IFA and IFB: Instrument constants, representing slope and intercept.
(d) Analytical items
BUN, CRE etc.

72
9.4. Kinetic
The concentration or activity level is obtained from the change in absorbance between the
specified measurement points. Below figure explains the Kinetic assay.

Abs R1＆ S Abs R1＆ S R2

S E T S E T

(a) Reagent setting screen input:

Assay/Point: input Kinetic S E
Single reagent: 1<S<E≤33
Double reagent: 10<S<E≤33
(b) Calculation of absorbance
The change in absorbance per minute between measurement point S and E is obtained by the
least squares method

AX = AS − E / min

(c) Calculation of concentration (Calibration type is linear):

C X = K  ( AX − B ) + C1  IFA + IFB

Cx: Concentration of standby sample

C1: Concentration of standard solution 1(reagent blank)
K: Factor
B: Absorbance of blank
IFA and IFB: Instrument constants, representing slope and intercept.
(d) Analytical items
AST, ALT, etc.

73
10. Appendix 2 Calibration type
Noun explanation:
⚫ Calculated value: The value that calculated automatically by machine.
⚫ Measured value: The value that measured by machine
⚫ Input value: The value that inputted by user.
⚫ Ax:
◼ For end point assay, it is the absorbance measured when using single wavelength, the
absorbance difference between primary and secondary wavelength when using double
wavelength.
◼ For kinetics assay, it is the absorbance change per minute of testing time.
◼ For fixed time assay, it is the absorbance difference between last point and first point
during testing time.
◼ For 2 point end assay, it is the absorbance difference between first step (sample) and
second step (sample blank).
For more details, please refer to appendix 1 calculation method.

10.1. 1 point linear

⚫ Calibration formula

C X = K  ( AX − B )

C x : (calculated value) the concentration of samples.

Ax : (measured value) the Ax of samples.
B : (measured value) the Ax of Reagent blank, If the blank is water, it is zero.
K : (input value) the value that inputted on Reagent setup dialog box.
⚫ Screen display
B, K will be displayed on Calibration Result screen.

74
10.2. 2 point linear

⚫ Calibration formula

C X = K  ( AX − B )

C1
K=
A1 − B
C x : (calculated value) the concentration of samples.
Ax : (measured value) the Ax of samples.
B : (measured value) the Ax of Reagent blank, If the blank is water, it is zero.
K : (calculated value) the value that calculated after calibration.
C1 : (input value) the concentration of standard 1.
A1 : (measured value) the Ax of standard 1.

⚫ Screen display
B, K will be displayed on Calibration Result screen.

75
10.3. Multi point linear

⚫ Calibration formula
X  Cr
B = A−
Y
Y
K=
X
n −1

(
X =  Cri − Cr  Ai − A
i =0
) ( )
n −1 2

(
Y =  Cri − Cr
i =0
)
 n−1 
A =   Ai  / n
 i =0 
 n−1 
Cr =   Cri  / n
 i =0 
C X = K  ( AX − B )

C x : (calculated value) the concentration of samples.

Ax : (measured value) the Ax of samples.
B : (calculated value) the parameters of calibration formula.
K : (calculated value) the parameters of calibration formula.
C ri : (input value) the concentration of standard i.
Ai : (measured value) the Ax of standard i.
n : (input value) the points of standard that inputted on Reagent setup dialog. It must be
within 3-8.

⚫ Screen display
B, K will be displayed on Calibration Result screen.

76
10.4. Line graph

⚫ Calibration formula
C X = K N  ( AX − AN ) + CN
CN +1 − CN
KN =
AN +1 − AN
N = [0, n − 2]
C x : (calculated value) the concentration of samples.
Ax : (measured value) the Ax of samples.
AN +1 : (measured value) the Ax of standard n+1.
AN : (measured value) the Ax of standard n.
C N +1 : (input value) the concentration of standard n+1.
C N : (input value) the concentration of standard n.
K N : (calculated value) the parameters of calibration formula.
n : (input value) the points of standard that inputted on Reagent setup dialog. It must be
within 3-8.

77
10.5. Logit-Log 3P

⚫ Calibration formula
K
AX = B +
1 + aCx
C x : (calculated value) the concentration of samples.
Ax : (measured value) the Ax of samples.
B : (calculated value) the parameters of calibration formula.
K : (calculated value) the parameters of calibration formula.
a : (calculated value) the parameters of calibration formula.

⚫ Screen display
B, K, a will be displayed on Calibration Result screen.

78
10.6. Logit-Log 4P

⚫ Calibration formula
K
AX = B +
1 + aCxb
C x : (calculated value) the concentration of samples.
Ax : (measured value) the Ax of samples.
B : (calculated value) the parameters of calibration formula.
K : (calculated value) the parameters of calibration formula.
a : (calculated value) the parameters of calibration formula.
b : (calculated value) the parameters of calibration formula.
⚫ Screen display
B, K, a, b will be displayed on Calibration Result screen.

79
10.7. Logit-Log 5P

⚫ Calibration formula
K
AX = B +
1 + exp ( −a − b  l n Cx − c  C x )
C x : (calculated value) the concentration of samples.
Ax : (measured value) the Ax of samples.
B : (calculated value) the parameters of calibration formula.
K : (calculated value) the parameters of calibration formula.
a : (calculated value) the parameters of calibration formula.
b : (calculated value) the parameters of calibration formula.
c : (calculated value) the parameters of calibration formula.

⚫ Screen display
B, K, a, b, c will be displayed on Calibration Result screen.

80
10.8. Exponential

⚫ Calibration formula

AX = B + K  expa  ( l n Cx ) + b  ( l n Cx ) + c  ( l n Cx )
2 3

C x : (calculated value) the concentration of samples.
Ax : (measured value) the Ax of samples.
B : (calculated value) the parameters of calibration formula.
K : (calculated value) the parameters of calibration formula.
a : (calculated value) the parameters of calibration formula.
b : (calculated value) the parameters of calibration formula.
c : (calculated value) the parameters of calibration formula.
⚫ Screen display
B, K, a, b, c will be displayed on Calibration Result screen.

81
10.9. Spline

⚫ Calibration formula

AX = a( I ) + b( I )  ( CX − C ( I ) + c(I) )  (CX − C ( I） ) + d (I)  (CX -C(I) )

3
2

I = [0, n − 2]
C x : (calculated value) the concentration of samples.
Ax : (measured value) the Ax of samples.
C ( I ) :(input value) the concentration of standard I.
K N : (calculated value) the parameters of calibration formula.
a( I ) :(calculated value) the parameters of calibration formula.
b( I ) :(calculated value) the parameters of calibration formula.
c( I ) :(calculated value) the parameters of calibration formula.
d ( I ) : (calculated value) the parameters of calibration formula.
n :(input value) the points of standard that inputted on Reagent setup dialog. It must be
within 5-8.

82
E-LAB Biological Science & Technology Co., Ltd.
Building 9, No. 1 Kechuang Road, Yaohua Street, Qixia District, Nanjing City,
Jiangsu Province, 210046, China
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