Auto Chemistry Analyzer: Operation Manual

Auto Chemistry Analyzer
Operation Manual
Declaration
The current version number of this manual is A/2, released in 2019-6-19, applicable for the
auto chemistry analyzer whose testing speed is 150tests/hour.This manual may be modified
as needed without prior notice.
For product safety, reliability and performance provided , the following requirements are met:
1) Installation, use, operation, maintenance and repair are performed by personnel

authorized by Manufacturer;
2) Any associated electrical equipment complies with national standards;
3) Use and operation of the instrument are performed in strict accordance with
this manual.
Manufacturer shall have the right of final interpretation for this manual.
Introduction
Introduction
We would like to sincerely thank you for choosing to purchase our auto chemistry analyzer.
Please read this manual carefully in order to ensure correct use of the apparatus.
After carefully reading this manual, please keep it safely stored so that you can refer to it
when necessary.
Product Name: Auto Chemistry Analyzer
Safety Classifications: Class II Overvoltage, Pollution Grade 2.
Management Classification: This device is classified as a Biochemical Analysis System

under the Clinical Testing Apparatus (6840) class; management classification: Class II.
Product Composition: The product primarily comprises an analysis unit, operating unit and
results output unit as well as various accessories, and supplies.
Scope of Product Application: This product is suitable for use in the quantitative analysis of
different samples using liquid reagents.
Contraindication：None
Manufacturing Date: see the label on the back of device
Life Span : 5 years
Revising Date of this manual: June 19th, 2019
i
Introduction
Manual Overview
This manual is focused on helping users to understand several aspects of this auto
chemistry analyzers, including safety, installation, structure and function, analysis principles,
operating procedures, maintenance and repair, alarms and treatment. Please operate the
apparatus in strict accordance with this manual in order to ensure proper use.
Symbols
The following is a list of symbols used in this manual.
Symbols Meaning
Warning! May cause damage to the analyzer or affect

test results.
May result in biological contamination.
May result in electric shock.
May cause corrosive damage.
High temperatures which may cause injury.
Glare which may cause eye injury.
May result in bodily injury.
Flammable substance which may result in a fire.
ii
Introduction
Screen Printing and Labels
The screen printings and labels listed below are used in this manual.
Labels Meaning
Device Serial Number
Protective Conductor Terminal
Manufacturing Date
Manufacturer
The product is an in vitro diagnostic device
The manufacturer’s catalogue number to

identify the medical device
Authorized representative in the European

Community.
～ AC
Power On
Power Off
CE Mark （CE certificated）
ON Power On
OFF Power Off
Serial Port Communication Port
Waste Liquid Outlet Waste Liquid Outlet
Purified Water Inlet Purified Water Inlet
Upward
iii
Introduction
Fragile , handle with care
Keep away from sunlight
Do not roll
Temperature limit
No Stacking
Humidity limitation
Keep dry
Atmospheric pressure range for safely

exposure
The analyzer, after being scrapped, should not

be disposed with other household garbage,
instead, it should be collected and recycled
following the WEEE regulations for scrapped
electronic and electrical equipment
Recyclable
Figures
All pictures included in this manual are used for descriptive purposes or as examples
only, and are not intended to be used for any other purposes.
iv
Contents
Contents
Introduction .............................................................................................. i
Manual Overview ................................................................................................................... ii
Symbols ................................................................................................................................... ii
Screen Printing and Labels ................................................................................................. iii
Figures .................................................................................................................................... iv
Contents .................................................................................................. 1
1. Safety and Precautions .................................................................. 7

1.1. Safety .......................................................................................................................... 7
1.1.1. Glare .................................................................................................................... 7
1.1.2. Combustibles...................................................................................................... 7
1.1.3. Explosion ............................................................................................................ 7
1.1.4. High Temperature .............................................................................................. 7
1.1.5. Electric Shock..................................................................................................... 7
1.1.6. Bodily Injury ........................................................................................................ 8
1.1.7. Biological Contamination .................................................................................. 8
1.1.8. Corrosion ............................................................................................................ 8
1.2. Precautions ................................................................................................................. 9
1.2.1. Scope of Use: ..................................................................................................... 9
1.2.2. Device Operator ................................................................................................. 9
1.2.3. Operating Environment ..................................................................................... 9
1.2.4. Electromagnetic Interference ........................................................................... 9
1.2.5. Improper Grounding .......................................................................................... 9
1.2.6. Loss of Label Stickers ..................................................................................... 10
1.2.7. Liquid Leakage ................................................................................................. 10
1.2.8. Probe Obstruction ............................................................................................ 10
1.2.9. Water Quality .................................................................................................... 10
1.2.10. System Use ...................................................................................................... 10
1.2.11. System Maintenance....................................................................................... 11
1.2.12. Samples ............................................................................................................ 11
1.2.13. Reagents, Calibrators and Control Fluids .................................................... 12
1.2.14. Cuvettes ............................................................................................................ 13
1.2.15. Analysis Parameters ....................................................................................... 13
1.2.16. Data Backup ..................................................................................................... 13
1.2.17. Disposing of the Instrument ........................................................................... 13
2. Installation ................................................................................... 14
2.1. Installation ................................................................................................................. 14
2.2. Damage Inspections................................................................................................ 14
2.3. Installation Requirements......................................................................................... 14
1
Contents
2.3.1. Environmental Requirements ........................................................................ 14

2.3.2. Computer Requirements ................................................................................ 15
2.4. Water Supply and Drainage Requirements ......................................................... 16
2.4.1. Water Supply Requirements .......................................................................... 16
2.4.2. Drainage Requirements ................................................................................. 16
2.5. Connecting Fluid Lines ........................................................................................... 17
2.6. Connect External Submersible Pump .................................................................. 20
2.7. Installing or Removing Sample /Reagent Disk.................................................... 22
2.8. Loading and Unloading Sample Test Tubes ........................................................ 23
2.9. Loading and Unloading Reagent Bottles ............................................................. 23
2.10. Installing the System Software .............................................................................. 24
3. Structure and Functions ............................................................. 29

3.1. Composition of the Analysis Unit .......................................................................... 29
3.1.1. Overall Structure.............................................................................................. 29
3.1.2. Top Structure ................................................................................................... 30
3.1.3. Rear Structure .................................................................................................. 30
3.1.4. Structure of the Left Side of the Analysis Unit ............................................ 31
3.1.5. Structure of the Right Side of the Analysis Unit.......................................... 32
3.2. Function Module ...................................................................................................... 32
3.2.1. Concentrated Wash Solution ......................................................................... 32
3.2.2. Diluent Wash Solution .................................................................................... 33
3.2.3. Sample Probe Mechanism ............................................................................. 34
3.2.4. Stirring Mechanism ......................................................................................... 35
3.2.5. Automatic Cleaning Mechanism ................................................................... 36
3.2.6. Reaction Disk ................................................................................................... 37
3.2.7. Thermostatic Groove ...................................................................................... 38
3.2.8. Reagent / Sample Disk ................................................................................... 39
3.2.9. Reagent Refrigerator ...................................................................................... 40
3.2.10. Optical System ................................................................................................. 40
4. Detailed Operating Procedure .................................................... 42

4.1. Operating Software ...................................................................................................... 42
4.1.1. Basic Procedure for Logging In ........................................................................ 42
4.2. Interface Layout ....................................................................................................... 43
4.2.1. Function Menu Area ........................................................................................ 44
4.2.2. Submenu Function Key Area ......................................................................... 44
4.2.3. Shortcut Button Area ....................................................................................... 44
4.2.4. Function Display Area ..................................................................................... 48
4.2.5. Status Bar ......................................................................................................... 48
4.2.6. Message Alert Area ......................................................................................... 49
4.3. Test Request ............................................................................................................ 50
4.3.1. Sample Request .............................................................................................. 50
4.3.2. QC Request...................................................................................................... 56
4.3.3. Calibration Request ........................................................................................ 58
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Contents
4.4. Online Status ............................................................................................................ 60

4.4.1. Sample Disk Status ......................................................................................... 60
4.4.2. Reagent Disk Status ........................................................................................ 63
4.4.3. Reaction Disk Status ....................................................................................... 69
4.4.4. Test List ............................................................................................................. 71
4.5. Query Results........................................................................................................... 72
4.5.1. Sample Result Query ...................................................................................... 72
4.5.2. Quality Control Result Query ......................................................................... 75
4.5.3. Calibration Result Query ................................................................................ 78
4.5.4. Reagent Blank Query ...................................................................................... 81
4.6. Para. Setup ............................................................................................................... 82
4.6.1. Routine Chemistry ........................................................................................... 82
4.6.2. Calculation Chemistry ..................................................................................... 91
4.6.3. Panels................................................................................................................ 93
4.6.4. Carryover .......................................................................................................... 95
4.6.5. Calibrator Setup ............................................................................................... 96
4.6.6. QC Setup .......................................................................................................... 98
4.7. Statistical Reports .................................................................................................. 100
4.7.1. Test Statistics .................................................................................................. 100
4.7.2. Workload Statistics ........................................................................................ 101
4.7.3. Charge Statistics ............................................................................................ 102
4.7.4. Result Statistics .............................................................................................. 104
4.8. Function Settings ................................................................................................... 105
4.8.1. System Setup ................................................................................................. 105
4.8.2. Hospital Setup ................................................................................................ 109
4.8.3. User Management ......................................................................................... 112
4.8.4. Print Setup ...................................................................................................... 115
4.8.5. Barcode Setup ............................................................................................... 118
4.9. System Maintenance ............................................................................................. 120
4.9.1. Routine Maintenance .................................................................................... 120
4.9.2. Log Management ........................................................................................... 122
4.9.3. Temperature Curve ........................................................................................ 123
4.9.4. AD Curve ........................................................................................................ 125
4.9.5. Probe Parameter Configuration ................................................................... 125
5. Simplified Operating Procedures .................................................. 131

5.1. Operational Procedures for Basic Functions ..................................................... 131
5.1.1. Add Item .......................................................................................................... 131
5.1.2. Change Item Parameters ............................................................................. 131
5.1.3. Delete Item ..................................................................................................... 132
5.1.4. Add Control Solution ..................................................................................... 132
5.1.5. Modify Control Solution................................................................................. 132
5.1.6. Delete Quality Control Solution ................................................................... 133
5.1.7. Add New Calibrator ....................................................................................... 133
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Contents
5.1.8. Modify a Calibrator ........................................................................................ 133

5.1.9. Delete a Calibrator ........................................................................................ 133
5.1.10. Set Reagent Positions .................................................................................. 134
5.1.11. Modify Reagent Information......................................................................... 134
5.1.12. Release Reagent Positions ......................................................................... 134
5.1.13. Reagent Blank Test Procedure.................................................................... 135
5.1.14. Calibration Test Procedure ........................................................................... 135
5.1.15. Quality Control Test Procedure ................................................................... 136
5.1.16. Sample Testing Procedure ........................................................................... 136
5.2. Operating Procedures for Opening a New Item ............................................... 137
5.3. Routine Operational Procedures ......................................................................... 138
5.3.1. Pre-Startup Check ......................................................................................... 138
5.3.2. Powering On the System ............................................................................. 138
5.3.3. Order of Operational Procedures ................................................................ 139
5.3.4. System Setup ................................................................................................. 139
5.3.5. Item Parameter Settings............................................................................... 139
5.3.6. Reagent Position Settings ............................................................................ 140
5.3.7. Calibrator Setup ............................................................................................. 140
5.3.8. QC Settings .................................................................................................... 140
5.3.9. Test Request .................................................................................................. 140
5.3.10. Test Preparation............................................................................................. 140
5.3.11. Start ................................................................................................................. 141
5.3.12. Test Result Query .......................................................................................... 141
5.3.13. Adding Tests ................................................................................................... 142
5.3.14. Shutdown ........................................................................................................ 143
5.3.15. Powering Off the System.............................................................................. 143
5.3.16. Post-Shutdown Inspection ........................................................................... 143
6. Analysis Principles and Computational Methods ...................... 145

6.1. Analysis Principle .................................................................................................. 145
6.2. Analysis Procedure ............................................................................................... 145
6.2.1. Actions Performed by the Device................................................................ 145
6.2.2. Operating Position ......................................................................................... 146
6.2.3. Testing Process ............................................................................................. 146
6.2.4. Optical Metering Point .................................................................................. 146
6.3. Analysis Methods and Reactivity Calculations ................................................. 148
6.3.1. Absorbance Calculation ............................................................................... 148
6.3.2. Endpoint Method ........................................................................................... 149
6.3.3. Two-Point Method (Fixed-Time Method) ................................................... 154
6.3.4. Kinetic Method ............................................................................................... 156
6.4. Calibration .............................................................................................................. 159
6.4.1. Calibration Types ........................................................................................... 159
6.4.2. Calculation of Calibration Parameters ........................................................... 159
6.5. Results Calculation ............................................................................................... 160
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Contents
6.6. QC ............................................................................................................................ 161

6.6.1. Quality Control Rules and Determination................................................... 161
6.6.2. Quality Control Query ................................................................................... 162
6.6.3. QC Charting.................................................................................................... 162
6.7. Other Related Calculations .................................................................................. 164
6.7.1. Calibration Curve-Related Calculations ..................................................... 164
6.7.2. Substrate Depletion Determination ............................................................. 166
6.7.3. Linearity Test .................................................................................................. 166
6.7.4. Prozone Check............................................................................................... 167
6.7.5. Determination of Lamp State ....................................................................... 169
6.7.6. Examination of Cuvette Cleanliness ........................................................... 169
7. Care and Maintenance .............................................................. 170

7.1. Preparation of Tools............................................................................................... 170
7.2. Daily Maintenance ................................................................................................. 170
7.2.1. Wiping Down the Analyzer Countertop ...................................................... 170
7.2.2. Cleaning the Sample Probe / Mixer ............................................................ 171
7.2.3. Inspecting the Reagent / Sample Syringe ................................................. 172
7.2.4. Inspecting the Purified Water Bucket.......................................................... 173
7.2.5. Inspecting the Waste Liquid Container / Tubing ....................................... 173
7.3. Weekly Maintenance ............................................................................................. 174
7.3.1. Cleaning the Cuvette Cleaning Probes ...................................................... 174
7.3.2. Cleaning the Primary Purified Water Filter ................................................ 175
7.3.3. Cleaning the Waste Liquid Container ......................................................... 176
7.3.4. Cleaning the Reagent / Sample Disk Refrigeration Unit.......................... 176
7.4. Monthly Maintenance ............................................................................................ 177
7.4.1. Cleaning the Cleaning Pool ......................................................................... 177
7.4.2. Cleaning the Thermostatic Groove of the Reaction Disk ........................ 177
7.4.3. Wiping the Driving Rod ................................................................................. 179
7.4.4. Check and Replace Cooling Water ............................................................. 179
7.4.5. Clean the Dust Filter ..................................................................................... 179
7.5. Semi-Annual Maintenance ................................................................................... 179
7.5.1. Replacing the Primary Filter......................................................................... 179
7.5.2. Replacing the 45 Micron Filter ..................................................................... 180
7.6. Unscheduled Maintenance ................................................................................... 180
7.6.1. Unblocking the Sample and Reagent Probes ........................................... 180
7.6.2. Replacing the Sample Probe ....................................................................... 181
7.6.3. Replacing the Mixer....................................................................................... 183
7.6.4. Replacing the Lamp ...................................................................................... 184
7.7. Replaceable Part List ............................................................................................ 185
7.7.1. The following is a list of items that can be replaced by the user ......... 185
7.7.2. List of Parts that Require a Maintenance Engineer for Replacement ... 186
7.8. Maintenance Log ................................................................................................... 187
8. Alarm Information and Processing .......................................... 190
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Contents
8.1. Overview ................................................................................................................. 190

8.2. Alarm Information Inquiry ..................................................................................... 190
8.2.1. Error Code Definition .................................................................................... 190
8.2.2. Instrument Runtime Error Table .................................................................. 191
Appendix A .......................................................................................... 213

A.1. Common Terms...................................................................................................... 213
A.1.1. AD Value ......................................................................................................... 213
A.1.2. Dark Current ................................................................................................... 213
A.1.3. Water Blank .................................................................................................... 213
A.1.4. Optical Metering Point .................................................................................. 213
A.1.5. Absorbance .................................................................................................... 213
A.1.6. Reaction Curve .............................................................................................. 213
A.1.7. Reactivity ........................................................................................................ 214
A.1.8. Calibration ...................................................................................................... 214
A.1.9. Calibration Curve ........................................................................................... 214
A.1.10. Calibration Parameter ................................................................................... 214
A.2. Technical Parameters ........................................................................................... 215
A.3. Power Requirements ............................................................................................ 216
A.4. Operating Ambient Temperature and Humidity Requirements ....................... 216
A.5. Computer and Printer Configuration ................................................................... 216
A.6. Communication Interface ..................................................................................... 217
A.7. Dimensions and Weight........................................................................................ 217
A.8. Options .................................................................................................................... 217
A.9. Other........................................................................................................................ 217
A.10. Transport and Storage Requirements ................................................................ 217
A.11. Safety Classifications ............................................................................................ 217
A.12. After-Sales Service ............................................................................................... 218
A.13. Warranty Service ................................................................................................... 218
A.14. EMC Description................................................................................................... 218
A.15. Removal of equipment from use for repair or disposal ................................... 220
A.16. Toxic or Hazardous Substances and Elements ............................................... 221
6
Safety and Precautions
1. Safety and Precautions

The following are warning symbols used in conjunction with this auto chemistry analyzers.
Ignoring these symbols may result in death or serious injury. The order in which the symbols
are given is in no way indicative of importance and all symbols are of equal importance.
1.1. Safety
1.1.1. Glare
Do not look directly into any beams of light, including those produced
by light sources and barcode scanners, as these beams can harm
your eyes.
1.1.2. Combustibles
Do not use any dangerous flammable substances, such as alcohol,
ether, etc. near the analyzer.
1.1.3. Explosion
Do not use any potentially explosive dangerous articles near the
analyzer.
1.1.4. High Temperature

1) Before replacing any lamps, turn off the power switch of the
apparatus, and wait at least 30 minutes until the lamp has cooled
down;
2) Contact with the heater or metal objects around the heater may
cause burns.
1.1.5. Electric Shock

1) Non-authorized service personnel should not open the analyzer's
paneling or side and back covers while the device's power is turned on;
2) Spillage of liquid on the device's countertop should be avoided and in

the event that a spill does occur, please power off the device
immediately and contact service promptly;
3) The internal parts of computers, printers and other components are

under high voltage, so please do not touch the interior of these
devices.
7
1.1.6. Bodily Injury

1) Please be careful with the sharp elements of the analyzer, such as
reagent probe tips, sample probe tips, mixers, and the steel piping of
the device's self-cleaning mechanism, as a failure to do so can result in
injury;
2) When the analyzer is running, do not touch any of its moving parts,
including the sample probe tips, reagent probe tips, mixer, automatic
cleaning mechanism or fans.
1.1.7. Biological Contamination

1) All test samples, calibrators, controls, etc., should be considered
contagious and protective gloves should be worn when coming into
contact with these objects; additionally, work clothes should be worn
to avoid infection and eyewear should be worn if necessary;
2) All waste liquid should be considered contagious and protective

gloves should be worn when coming into contact with it; additionally,
work clothes should be worn to avoid infection and eyewear should
be worn if necessary;
3) All device components that have been in contact with test samples,
such as reagent probes, sample probes, mixers, cleaning
mechanisms, waste liquid tubing, waste liquid containers and
reaction cuvettes should be regarded as contagious, and protective
gloves should be worn when coming into contact with these objects;
additionally, work clothes should be worn to avoid infection and
eyewear should be worn if necessary.
1.1.8. Corrosion
1) Wash solution and some reagents are strongly acidic or alkaline, and
protective gloves should be worn when coming into contact with
these substances; additionally, work clothes should be worn to avoid
infection and eyewear should be worn if necessary; Measures should
be taken to prevent contact between the user's hands and clothing; In
case of contact, immediately wash the affected area with plenty of
soap and rinse thoroughly with water;
2) In the event that any of the aforementioned fluids enter the user's
eye, rinse the affected eye immediately with plenty of water and
consult an ophthalmologist.
8
1.2. Precautions
1.2.1. Scope of Use:

1) This product is suitable for use in the quantitative analysis of different
samples (including serum, plasma, urine, cerebrospinal fluid, etc.)
using liquid reagents.
2) When making a clinical diagnosis using test results, a comprehensive

determination should be made that also incorporates the patient's
clinical symptoms, as well as the results of other clinical examinations
and tests.
1.2.2. Device Operator

1) This device may only be operated and used by authorized personnel
who have undergone training provided by Manufacturer or authorized
representatives of Manufacturer.
1.2.3. Operating Environment

1) Please install the device properly in an environment that conforms to
the specifications outlined in this manual. The installation or use of the
device under conditions other than those specified may result in
reduced reliability as well as harm to the analyzer;
2) If the operating environment of the analyzer needs to be modified,

please contact Manufacturer or the authorized Manufacturer agent for
your region.
1.2.4. Electromagnetic Interference

1) The analyzer is susceptible to electromagnetic interference during
operation which may affect measurement results and lead to
operational errors. Please do not use devices that emit
electromagnetic radiation, such as electric drills, mobile phones or
walkie-talkies while the analyzer is running;
2) The analyzer will emit electromagnetic radiation during operation.

Do not install or use electromagnetically-sensitive devices near
the analyzer.
1.2.5. Improper Grounding

1) The power supply unit must be properly grounded. Failure to ground
the power supply presents a risk of electric shock;
2) Ground impedance must be less than 0.1Ω; poor grounding can

cause instability in measurement results and electrical leakage from
the enclosure, producing a shock hazard.
9
1.2.6. Loss of Label Stickers

1) When stickers on the instrument become faded or fall off, please
contact Manufacturer for a replacement.
1.2.7. Liquid Leakage

1) Fittings for all tubing should be carefully checked before each test to
check for any leaks. Liquid leakage can cause inaccurate suction and
emission;
2) To avoid liquid spills and leaks, do not put reagents and samples on
the analyzer table.
1.2.8. Probe Obstruction

1) Carefully check reagents and samples to ensure that no insoluble
compounds, such as cellulose or fibrin, are present. Failure to do so
may result in obstruction of the reagent or sample probes.
1.2.9. Water Quality

1) Water quality should meet Class 2 national standards for laboratory
water. Use of lower-grade water can easily lead to valve or pump
damage as well as difficulty cleaning the apparatus.
1.2.10. System Use

1) Follow the instructions contained in the manual when using the system.
Incorrect use may result in incorrect measurement results, and
furthermore may even result in system damage or personal injury.
2) Before using the system for the first time, please first perform a
system calibration followed by the relevant quality control procedures
in order to verify that the system is working properly.
3) When using the system on a regular basis, it is recommended that

quality control procedures are used to ensure the reliability of
measurement results.
4) During analysis, do not open the reaction disk cover.
5) Before performing an analysis, close the reaction disk cover and

reagent / sample disk cover.
6) During the analysis process, make sure there are no obstructions in

the probe or in the path of the mixer.
7) In order to prevent injury, do not touch the reaction disk and sample
and reagent disk while they are spinning.
10
8) Do not install any hardware or software onto the computer comprising

the operating unit other than the software and hardware specified by
Manufacturer. The installation of non-specified hardware or software
may interfere with the normal operation of the system. Do not run
other software while the system is working.
9) Do not use the computer comprising the operating unit for any other
purposes. Improper use may result in viral infection of the computer.
Computer viruses can be propagated via USB thumb drives,
programs and networks, as well as via other means.
1.2.11. System Maintenance

1) Please follow the instructions in this manual when performing system
maintenance. Incorrect maintenance procedures may result in
incorrect measurement results, and furthermore may even result in
system damage or personal injury.
2) After replacing major system components, such as the light

photometer, pipetting probe or syringe piston assembly, a calibration
should be performed.
3) When using the instrument in South Asian countries which feature

high temperatures, low humidity, and extremely dry conditions
(including India, Pakistan, Bangladesh, Sri Lanka, etc.). As these do
not fall within the range of normal operating conditions for the
instrument, maintenance such as dust removal and add coolant into
coolant pump should be performed regularly.
4) If use of the instrument is stopped due to malfunction and repairs or

treatment are needed, please contact Manufacturer or the authorized
Manufacturer agent for your region and concurrently take the
following measures:
Use other devices or methods to complete unfinished tests in order to
avoid delays.
5) Please remove reagents from the instrument and store them according
to the reagent instructions after the testing, such as returning one or
more reagents to a refrigerator for cold storage, in order to prevent
reagent deterioration.
1.2.12. Samples
1) Please use completely separated serum samples and urine samples
which do not include any suspended solids. If a serum sample
contains fibrin or a urine sample contains suspended solids, the
Sample probe may become obstructed, affecting the accuracy of
analysis results.
11
2) Drugs, anticoagulants, preservatives, etc. which are present in a

sample may interfere with some analysis results.
3) Lipemia, jaundice and hemolytic samples may affect analysis results

so it is recommended that a blank sample analysis be performed.
4) Please store samples correctly. Incorrect sample storage conditions

may alter the composition of samples, thus affecting the accuracy of
analysis results.
5) In order to prevent sample evaporation, do not leave the sample open

for an extended period of time. Failure to do so may affect the
accuracy of analysis results.
6) There are requirements concerning sample volume when performing

an analysis with the system. When taking a sample, make sure
that the sample size is appropriate based on the instructions given in
this manual.
7) Prior to analysis, make sure the sample is positioned correctly. Failure

to do so will make it impossible to obtain accurate results.
1.2.13. Reagents, Calibrators and Control Fluids

1) When using the system to perform an analysis, please use the
appropriate reagents, calibrators and control fluids.
2) Please select and use reagents that are suited to the system. In the
event that the suitability of a reagent cannot be determined, please
contact the Manufacturer or distributor of the reagents, Manufacturer
or one of Manufacturer's distributors.
3) For information concerning the use and storage of reagents,

calibrators and control fluids, refer to the Manufacturer or distributor's
instructions.
4) If reagents, calibrators, or control liquids are improperly stored,

correct test results may not be obtained, even prior to the
corresponding expiration date.
5) Please perform a calibration after replacing reagents. Failure to

perform calibration and a quality control analysis may result in
inaccurate test results.
6) The presence of reagent cross contamination during analysis

may affect test results. For more information concerning reagent
cross-contamination, please consult the reagent Manufacturer
or distributor.
7) Prior to analysis, make sure the sample is positioned correctly. Failure

to do so will make it impossible to obtain accurate results.
12
1.2.14. Cuvettes
This analyzer employ semi-permanent rigid cuvettes. Please use cuvettes
designated by Manufacturer and discard it after use (for the device with
automatic cleaning mechanism, the wash mechanism could clean the
cuvettes to make it reusable with a service life of 3 months), or it may
result in a failure to obtain the desired level of performance.
1.2.15. Analysis Parameters

Incorrect analysis parameters can lead to erroneous measurement results.
Please consult Manufacturer or your reagent supplier for more information.
1.2.16. Data Backup

The system performs automatic backups which are stored on the
computer's hard drive. If data on the computer's hard disk are deleted or
the hard drive is otherwise damaged, data loss will result. Please
periodically backup analysis data and analysis parameters to other mobile
storage devices.
1.2.17. Disposing of the Instrument

Some substances contained in the analyzer are subject to anti-pollution
regulations during disposal. Please adhere to local waste disposal
standards when disposing of the analyzer.
13
Installation
2. Installation
2.1. Installation
This auto chemistry analyzers should only be installed by Manufacturer or an authorized

Manufacturer agent and the customer must provide an appropriate environment and space
for the installation. When the analyzer needs to be relocated, please contact Manufacturer
or an authorized Manufacturer agent. When you receive your analyzer, please immediately
notify Manufacturer and the authorized local Manufacturer agent in your area.
2.2. Damage Inspections
All analyzers are subject to a strict inspection by Manufacturer before packing and shipping.
After you have received your analyzer, before opening the packaging, perform a thorough
inspection and note whether any of the following damage is present:
1) Packaging is inverted or misshapen;
2) Packaging has obvious signs of water damage;
3) Packaging has obvious signs of being hit;
4) Packaging shows signs of having been previously opened:
If you notice any of the above instances of damage, please immediately notify Manufacturer
and the authorized local Manufacturer agent in your area.
If the packaging is intact, open the box while Manufacturer staff and/or authorized agent
personnel are present, and perform the following checks once the packaging has been
opened:
1) Verify that all equipment parts are present using the packing list contained inside the
box;
2) Carefully check the appearance of all equipment, noting any cracks, impacts or
deformation.
2.3. Installation Requirements
2.3.1. Environmental Requirements

2.3.1.1 Power Supply
1) 100-240V, 50/60Hz±1 Hz(recommended that the customer should use a UPS);
14
Installation
2) Proper grounding; grounding resistance less than 10mΩ; If the power supply is
poorly grounded, a copper wire of impedance less than 0.1Ω should be connected
to the rear of the device's analysis unit and buried directly in the ground.
2.3.1.2 Site and Space

1) The ground on which the device is placed should be level with an incline gradient
of less than 1/200 and sufficient strength to withstand a weight of 75kg;
2) The environment should be free of dust as well as corrosive and flammable gases,
heat and air sources, and mechanical vibration;
3) Avoid exposure to direct sunlight;
4) Air exchange with the outside with smooth circulation should be present; the
ventilation source should not blow directly onto the analysis unit of the device;
5) The device should not be positioned close to brush-type motors and electrical
contact equipment that is regularly switched on and off;
6) Space Requirements:
2.3.1.3 Temperature, Humidity and Atmospheric Pressure

1) Environmental Temperature: 10 °C - 30 °C.
2) Relative Humidity: 30% - 85%.
3) Atmospheric Pressure: 86.0 kPa - 106.0kPa.
2.3.2. Computer Requirements

The computer must meet the relevant safety requirements and be preloaded with
Windows 7/10, with a CPU clock speed of 2.0 GHz or greater and more than 4.0GB of
RAM. More than 40G hard space disk space.
Operation system : Win7 / Win 10
15
Installation
2.4. Water Supply and Drainage Requirements
2.4.1. Water Supply Requirements

1) The quality of water supplied to the device should comply with CAP Class 2 water
standards;
2) Water Supply Volume: No less than 10 L/h;
3) If using water purification equipment, the water supply must be gravity-based;
4) The distance between the water supply device and biochemical analyzer inlet
should not exceed 10 meters.
Notes:
The quality of water supplied to the device should comply with CAP Class 2
water standards.
2.4.2. Drainage Requirements

1) Please follow local environmental regulations when discharging waste liquid;
2) Connection to Waste Collection Container: The waste collection container can be

on a horizontal surface below the instrument; it is important to ensure that the waste
collection container be positioned lower than the waste liquid outlet on the left door
of the device;
3) Connection to sewer system: The waste liquid discharge port should not be more
than 12 cm from ground level;
4) Waste liquid tube length should not exceed 5 meters.
Biological Contamination:
During operation, be sure to wear protective gloves and clothing to prevent
contamination.
Please process waste discharged by the biochemical analyzer according to
your local waste emission standards.
16
Installation
2.5. Connecting Fluid Lines
For analyzer using internal cooling pump, please connect fluid lines as shown in the
following Figure. A description is given below:
1) Connect the waste outlet tubes with the waste outlet connectors in the back side of
analyzer, connect the other ends of tubes into waste container (please leave proper
length and cut the waste tube before connecting). Waste Outlet discharges
wastewater used to clean the device's probe, mixer and cuvettes; output from this
outlet may be directly discharged to a municipal sewer system or waste liquid
container;
2) Connect waste detector line with the waste detector connector, put the waste
detector into waste container.
3) Connect the deionized water inlet tube with the water inlet connector in the left side
of analyzer, put the end of the tube together with a filter which is connected with the
tube into the water container. Deionized Water Inlet provides the analyzer with
deionized purified water to wash the probe and mixer; this inlet may be directly
connected to a purified water bucket.
4) Connect deionized water detector line with the deionized water detector connector,
put the detector into water container.
5) The concentrated waste (for the device with automatic cleaning mechanism only）
combined by waste reagent and sample needs to be discharged into concentrated
waste bucket. The ―waste‖ from another port which is the liquid from wash well
can be discharged to sewer or waste bucket.
Notice:
Both DI water container and waste container should be set down to a lower place than the
analyzer.
The DI water container opening should not be higher than the analyzer DI water inlet port,
17
Installation
their distance should be within 1 meter.
The waste container opening should be lower than the analyzer waste outlet port.
18
Installation
Notice:
For analyzer without auto wash function, there is no CON.WASTE OUT.
For analyzer using external submersible pump, please follow the instruction in Section 2.6.
19
Installation
2.6. Connect External Submersible Pump
For analyzer using external submersible pump only:
20
Installation
External tanks connection is shown as below:
Notice:
For analyzer without auto washing function, there is no CON.WASTE OUT.
21
Installation
2.7. Installing or Removing Sample /Reagent Disk
Operation
1) To load the reagent / sample disk, hold the handle in the middle of the reagent /
sample disk firmly with your hand and align the alignment hole underneath the
handle with the alignment pin in the middle of the reagent / sample refrigeration unit
and place it down gently.
2) To remove the reagent / sample disk, pull to loosen the two lockers, raise the
handle of the reagent / sample disk to the vertical position and remove the disk.
Figure 2-1: Diagram of the Reagent / Sample disk
Warning:
When inserting or removing the reagent / sample disk, first verify that
all operating parts of the instrument, such as the Sample probe,
mixer, cleaning mechanism, reaction disk and reagent / sample disk,
have ceased operating.
During operation, be sure to wear protective gloves and clothing to
prevent contamination.
Notes:
1) When using the instrument, ensure that the reagent / sample disk
cover is closed. Failure to do so may adversely affect the cooling
system's functionality and result in damage to the sample probe.
2) The reagent / sample disk and refrigeration unit may be

contaminated by samples during use. When a sample or reagent
splashes onto the reagent / sample disk or refrigeration unit, wipe
the affected area with a cloth or towel soaked in water or
disinfectant after turning off the power supply of the analysis unit.
22
Installation
2.8. Loading and Unloading Sample Test Tubes
Operation
1) When loading vials, place the vials containing the desired samples in the sample
apertures of the sample disk until they are fully inserted in their respective sample
apertures.
2) When loading sample test tubes, place test tubes containing the desired samples
in the sample apertures of the sample disk until they are fully inserted in their
respective sample apertures.
3) When removing vials or sample test tubes, pinch the vial or sample test tube with
your hand, raise it to the vertical position and remove.
Warning:
Before inserting or removing a sample tube, you should verify that the
sample probe and sample disk of the analyzer have both ceased operating.
Please do not use sample test tubes other than those within the specified
size range.
During operation, be sure to wear protective gloves and clothing to
prevent contamination.
2.9. Loading and Unloading Reagent Bottles
Operation
1) When loading a reagent bottle, place the reagent bottle containing the desired
reagent in the reagent bottle slot of the reagent disk until the bottom of the reagent
bottle makes contact with the bottom of the reagent bottle slot.
2) When removing a reagent bottle, pinch the opening of the reagent bottle, raise it to
the vertical position and remove.
Warning:
Before inserting or removing a reagent tube, you should verify that the reagent
probe and reagent disk of the analyzer have both ceased operating.
During operation, be sure to wear protective gloves and clothing to prevent
contamination.
23
Installation
2.10. Installing the System Software
Operation
1) Turn off windows firewall and exit all antivirus program. Open the software CD and
click on the exe file to begin the software program installation process. The
following windows will appear.
2) The following screen appears, select a language and click "OK" to continue. Select
―English‖ first, later in the program you can change to other display language.
3) Choose the correct version according to whether the analyzer has auto wash
function or not, click ―Next‖ button.
24
Installation
4) Click "Next‖ after choosing a folder to install the program. Default folder is
recommended. .
5) Click "Next" to continue.
25
Installation
6) Click ―Install‖.
7) For the first time installation, it will automatically install .net framework 4.5 which may
take a while for installation. Please wait.
8) At the end of the installation, the following window will appear. Simply click the
"Finish" button.
26
Installation
9) Once the above installation process is complete, the software is successfully

installed. Double-click the software icon on the desktop to run the software.
10) If you need to adjust optional modules or the display language, run the software
and at the login screen, move the mouse to the area which is to the right side of the
username box, and double click.
Use an account with rights to change the module configuration to log in.
27
Installation
11) Select the desired modules and functions, click ―Save‖. Peristaltic Pump must be
selected for analyzer with auto wash function
Note:
1) The files in the disk is recommended to be copied to local disk. During
software installation, the installation ―AutoClient.exe‖ program and the
“Dependencies‖ folder must be in the same directory.
2) For the analyzer which is configured with ISE module, Barcode

scanner or Touch Screen Module, please tick to choose the
corresponding modules in above step 10), otherwise the module will
not be active after logging in.
28
Structure and Functions
3. Structure and Functions

This auto chemistry analyzer consists of two major components: one is the analysis unit
and the other is the operating unit. The analysis unit automatically completes the
operational process for each test, including washing reaction cuvettes, loading of the first
reagent, sample loading, sample stirring, loading of the second reagent, stirring of the
second reagent and absorbance measurements performed during the reaction process.
The operating unit drives and controls the analysis unit during the completion of all
analysis procedures.
3.1. Composition of the Analysis Unit
3.1.1. Overall Structure
1 Main Enclosure 2 Front Cover 3. Tray
29
3.1.2. Top Structure
1: Main Enclosure 2: Automatic Cleaning Mechanism

3: Mixer 4: Reaction Disk
5: Reagent/Sample Probe 6: Reagent/Sample tray
3.1.3. Rear Structure

For analyzer with internal cooling pump:
30
For analyzer with external submersible pump:
1: Main Power Switch 2: Main Power Port 3: Communication Port (RS232)
3.1.4. Structure of the Left Side of the Analysis Unit
31
3.1.5. Structure of the Right Side of the Analysis Unit
1. Analysis Unit Power Switch
3.2. Function Module
3.2.1. Concentrated Wash Solution

For analyzer with auto wash function only:
Concentrated Wash Solution Bottle
32
a) Function
Used for cleaning the reaction cuvette, cleaning the reaction cuvette after prepared
according to an automatic online dilution of concentrated wash solution : washing water
= 1: 9 by volume.
Insert the tube left on the panel into ―wash concentrate‖ wash solution bottle to use it
directly.
b) Specification
1000 ml
3.2.2. Diluent Wash Solution
Wash solution Slot
c) Function
Used to clean sample probe and the mixer.
Fill the bottle with ―Wash Dilution‖ cleaning solution and put it in this slot.
d) Specification
60 ml (the bottle under the slot)
33
Notes:
We recommend a daily cleaning with the ―WASH DILUTION‖ cleaning

solution (provided by Manufacturer) as well as a weekly cleaning with both
an acidic cleaning solution and alkaline cleaning solution (one wash each)
according to the concentration advised as below:
1) Acidic Cleaning Solution: 0.1 mol/L hydrochloric acid;
2) Alkaline Cleaning Solution: Sodium hypochlorite solution with an
effective chlorine content of 0.5%.
Please only use cleaning solutions recommended as above by

Manufacturer. Failure to do so may result in a failure to obtain expected test
results.
3.2.3. Sample Probe Mechanism
Sample probe mechanism
a) Function
Aspirates a predetermined amount of reagent/sample from a reagent/sample tube and

dispenses the reagent/sample into a cuvette.
b) Specification
Reagent: 10 - 450 μL in 1 μL increment
Sample: 2 - 50 μL in 0.1 μL increment
34
c) Action
Raises and lowers in the following positions.
1 2 3
Reagent bottle Cuvette Wash pool
1 2 3
Sample tube Cuvette Wash pool
d) Fluid Line Diagram
3.2.4. Stirring Mechanism
Stirring Mechanism
a) Function
35
Stirs the reaction solution inside the cuvette.
b) Action
Raises, lowers and rotates in the following positions.
3.2.5. Automatic Cleaning Mechanism

For analyzer with auto washing function only:
Automatic Cleaning Mechanism
a) Function
automatically cleans cuvettes.
b) Action
Moves up and down in the reaction cuvette, drawing up the reaction solution completely
and filling the cuvette with deionized water and concentrated wash solution.
36
3.2.6. Reaction Disk
Reaction disk
a) Function
Load the cuvette and allow the sample and reagents to react at 37°C in the reaction
Compartment. Colorimetric measurements are carried out directly using the cuvette.
b) Specification
Number of Cuvettes: 50;
Cuvette Materials: Semi-permanent Ultraviolet transmission specialty plastic;
Specification 5*5*30 (mm);
Optical Path Length: 5 mm;
c) Action
Clockwise rotation.
37
3.2.7. Thermostatic Groove
Reaction Compartment Structure
a) Function
Maintains a temperature of 37°C for the reaction solution contained in the cuvette.
b) Specification
Rated Temperature: 37°C;
Temperature Accuracy: 37°C ± 0.3°C;
Temperature Fluctuation: ± 0.2°C.
38
3.2.8. Reagent / Sample Disk
Reagent / Sample disk
a) Function
Various reagent bottle / sample tube carriers can be used to move reagent bottles /
sample tubes over to the Sample probe Sample location via rotation.
b) Specification
Disc with three concentric circles for a total of 40 reagent / 40 sample positions.
The sample disk is compatible with the following sample containers:
Miniature Sample Vials: Φ12×37mm, Φ14×25mm;
Traditional Blood Collection Tubes: Φ12×68.5 mm, Φ12×99 mm, Φ12.7×75 mm,
Φ12.7×100 mm, Φ13 × 75 mm, Φ13 × 95 mm, Φ13 × 100 mm;
Plastic Test Tubes: Φ12×68.5 mm, Φ12×99 mm, Φ12.7×75 mm, Φ12.7×100 mm,
Φ13 × 75 mm, Φ13 × 95 mm, Φ13 × 100 mm.
The sizes of reagent bottles which can be used with the reagent disk are 30 ml
and 15 ml for the inner and outer rings respectively.
39
Notes:
1) Sample Position No. 40 is used exclusively for reagent blank samples.

Please only insert sample tubes containing de-ionized water or saline
solution to provide a blank sample for use during reagent blank testing.
c) Action
Clockwise and counterclockwise rotation.
3.2.9. Reagent Refrigerator
Reagent Refrigerator
a) Function
Insert the reagent and sample disks to refrigerate reagents.
b) Specification
Refrigeration of all reagents at a temperature of 4 - 12°C.
3.2.10. Optical System

a) Function
Measure the absorbance of the reaction solution inside the cuvette during rotation of the
reaction disk.
b) Specification
40
Wavelengths: 340, 405, 450, 510, 546, 578, 630 and 670 nm; total 8 wavelengths;
Number of simultaneously detectable wavelengths: One or two wavelengths can be
simultaneously measured;
Wavelength Accuracy: ± 2nm;
Half-Wave Width: Less than 12nm;
Inspection Element: Photodiode array;
Source: Tungsten halogen lamp, 12V 20W;
c) Diagram
41
Detailed Operating Procedures
4. Detailed Operating Procedure

All pictures in this section show examples only; please perform operations according to the
actual interface displayed.
4.1. Operating Software
4.1.1. Basic Procedure for Logging In

The basic procedure is as follows:
1) Find the shortcut for the operating software as shown below and double-click it to start
the software:
Figure 4-1: The shortcut icon of the operating software
2) In the software login screen that pops up (see Figure 4-2), enter an appropriate
username and password to log into the software. In the login screen, you can also
select the startup procedures, change the login password and perform database
backup / restore operations.
Figure 4-2: Main interface of the operating software
Note: The first time log in this program, in the ―Startup Procedure‖, please choose all
procedures then click ―Login‖ button.
42
Startup Initializtion Reset Process: To reset all mechanism parts, must be selected
everytime log in the program.
Wash All Reaction Cuvettes: For analyzer with auto washing function only. To wash all
50 cuvettes after all mechanism parts reset.
Water Blank Test: For analyzer with auto washing function only. To perform a water
blank test after washing all cuvettes.
4.2. Interface Layout
The operating interface of this auto chemistry analyzer includes a function menu area,
function display area, status bar and alert message area, as shown below:
Figure 4-3: Main interface of the operating software
43
4.2.1. Function Menu Area

There are seven major menus within the operating system and each major menu includes
submenus organized by function for changing corresponding settings and performing
corresponding operations. A detailed description is provided below:
1) Test Request Include 4 submenus: sample request, QC request, calibration request
and reagent blank request. Also supports functions such as the input of patient
information as well as the release of sample position and sample ID.
2) Online Status Include 4 submenus: sample disk, reagent disk, reaction disk and test list.
3) Result Include 4 submenus: sample, QC, calibration and reagent blank.
4) Statistics Include 4 submenus: test statistics, workload statistics, charge statistics and
result statistics.
5) Parameter Include 6 submenus: routine chemistry, calculation chemistry, Panels,
Carryover, calibrator setup and QC setup.
6) Function Setup Include 5 submenus: system setup, hospital setup, user manage, print
setup, and barcode setup.
7) System Maintenance Include 5 submenus: routine maintenance, log management,
temperature curve, AD curve and probes parameters.
4.2.2. Submenu Function Key Area

Each submenu is assigned different function keys according to their different functions.
The specific features of each submenu will be discussed in detail in each submenu's section
in this manual.
4.2.3. Shortcut Button Area

4.2.3.1. Start
Button:
Description of Function: Initiates tests that need to be started.

Basic operational steps:
1) Click on the Start button in the Shortcut Button Area to bring up the test start
dialog box as shown below:
44
Figure 4-4: "Start Test" Screen

2) Select the required test modes, sample disk, reagent disk, and the date of the
application;
3) Select the type of test;
4) Enter the test sample number range needed to start the test or directly enter a sample
number; in the event that no input is given, the software will start all tests by default
(including calibration, quality control and sample tests for which an application was made);
5) Click the "Start" button to confirm that you want to start the test or click the "Cancel"
button to cancel starting the test.
4.2.3.2. Suspension of Pipetting
Button:
Description of Function:
Suspends all ongoing tests for which R1 has not yet been added. Tests for which R1 has
already been added will continue with the addition of S (sample) and R2 to complete the test.
When pipetting is suspended, the reaction disk will continue to run; The sample disk and
sample probe stop, after which operations such as the addition of reagent can be
performed.
Basic Operational Steps:
Click on the "Pause" button in the right shortcut button area; Click "Yes" in the dialog box
that pops up; The instrument will perform a pipetting suspension operation; After pipetting is
suspended, click the "Start" button on the right side of the screen to resume testing.
45
4.2.3.3. Stop
Button:
The system will stop all ongoing testing and unfinished tests will be voided.
Basic Operation:
Click on the "Stop" button in the right shortcut button area and click the "OK" button in the
dialog box that pops up. The analyzer will stop immediately; If you do not want to stop
current testing, click the "Cancel" button.
Notes:
After performing a stop operation, tests for which test results have not
been calculated will be voided.
4.2.3.4. Shut Down
Button:
Description of Function: Performs a system shutdown
Click on the "shutdown" button in the right shortcut button area to bring up the following
dialog box and select a shutdown mode as needed:
Figure 4-5: The shutdown screen

For analyzer with auto wash function:
If you wish to perform a standard routine shutdown, click on the "OK" button directly;
If you anticipate that the machine will not be turned on for a long period of time (several
days), first click on the "Long holiday shutdown" radio button and then click the "OK" button.
46
Notes:
1） When a standard ―routine shutdown‖ is performed, the system cuvette
will be filled with purified water; When a "Long holiday shutdown" is
performed, all water in the system cuvette will be drawn out.
2） Select "Turn off computer" to automatically turn off the computer after
system shutdown. (For analyzer without auto wash function, only ―Turn Off
Computer‖ option is displayed)
4.2.3.5. Emergency Shutdown
Button:
This operation should only be performed when the analyzer malfunctions during operation
or there is an error which requires an emergency stop of the instrument. During an
emergency shutdown, the analyzer does not perform any shutdown process before exiting -
the instrument stops running and all incomplete tests will be voided.
Click the "Emergency Shutdown" button and click the "Yes" button in the dialog box that
pops up to immediately exit the software; If you do not want to perform an emergency
shutdown, click the "No" button.
4.2.3.6. Routine Maintenance
Button:
Using the routine maintenance shortcut, you can quickly enter the routine maintenance
interface and perform routine maintenance operations on the instrument.
Click "Routine Maintenance" and, after entering the "Routine Maintenance" menu, select the
maintenance operations that need to be performed in order to execute them.
4.2.3.7. Lock System
Button:
While the system is running, the user can lock the system or switch the user operating the
machine.
Click the button to enter the "Lock system" screen and the system will be locked; If you need
to unlock the machine or switch users, enter the appropriate username and password.
47
4.2.4. Function Display Area

Displays information such as various data for corresponding menus when you click on a
function menu or submenu.
4.2.5. Status Bar

Displays the lamp, temperature, purified water container, waste liquid container and LIS
connection status. Purified water container and waste liquid container statuses are directly
displayed as icons and cannot be interacted with;
Lis icon : Double click the LIS icon to open the LIS Settings dialog box where you can setup
and connect to LIS.
Figure 4-6: "LIS" Setup Interface Screen
Temperature icon : Double click temperature icon to set target temperature of reaction disk.
Lamp icon : Double click the lamp icon to open AD curve detection screen.
DI water icon : The sensor will detect signal after DI water used out, and it will show
48
exclamation mark in the DI water icon.
Waste icon : The sensor will detect the signal after waste tank is full, and it will show
exclamation mark in the waste icon.
4.2.6. Message Alert Area

When using certain functions such as requesting tests, etc. or if the system malfunctions or
experiences an error, the information bar will display corresponding information or warnings;
the following function buttons are available:
"C": Clear the current message.
"A": Alarm/Error. Click to view information recorded by the system related to various
errors.
"V": Version. Check the software name and version information
: View the "previous" or "next" message
: View help information
49
4.3. Test Request
Requests for sample, quality control, calibration and reagent blank testing can be made via the
Test Request menu. The menu also supports various functions such as the entry of patient
information, selection of sample numbers, batch requests, retesting, dilution testing, etc.
4.3.1. Sample Request

In the Sample Request menu, the user can request sample tests and can specify
emergency or batch sample requests based on the actual requirements of the user. At the
same time, special functions such as sample blank testing, repeat testing and repeated
dilution and automatic dilution testing can also be requested; The history of requested items
can be checked or cleared in the Request List Menu.
Figure 4-7: The "Sample Request" Screen
4.3.1.1. Introduction of Basic Parameters

For an explanation of the meanings of various "Sample Request" screen parameters,
consult the following table:
Parameter Meaning
Disk Set to 5 by Default. Selection is made via a drop-down menu.
Refers to the disk position number (total of 40 possible) of the

selected sample. The number can be entered directly or you can
Sample Position
click on the right of the screen to select a number from the
sample disk empty vial list
50
Parameter Meaning
Refers to the number of the test sample. This parameter can be

entered directly into the corresponding box and once the request
Sample ID
is successful it increases in ascending order; can enter a prefix
and suffix
Allows the user to select the sample type; selection is made via a
Type
drop-down menu
When checked, the currently requested sample is designated as
STAT
an emergency sample and given priority during testing
Enter the batch number directly into the corresponding box to
Batch
simultaneously request multiple samples
Click to enter the detailed information input interface and enter
Detail
detailed information regarding a specific sample
Show all items and directly select specific requests based on
Chemistry List
your testing needs
Show panels and directly select specific requests based on your
Panels List
testing needs
Prev Click to look at the item list on the previous page
Next Click to look at the item list on the next page
4.3.1.2. Details
Detailed information on the sample and patient corresponding to the sample.
Figure 4-8: "Details" Screen
51
For explanations of different parameters and operations corresponding to the "Details"

screen, see the following table:
Parameter Meaning Operation
Name Current patient information Input directly into the box
Gender Gender of the current patient Selected from the drop-down box
Data is directly entered into the

first box and a selection from a
Age Age of the current patient
drop-down menu is made for the
second box
Species Current sample source type Selected from a drop-down box
Number of the blood bag

Blood Bag corresponding to the current Input directly into the box
sample
Sample Outward appearance of

Selected from the drop-down box
Character the sample
Blood type of the current

Blood Type Selected from the drop-down box
patient
Outpatient number of the

Register ID Input directly into the box
current patient
Inpatient number of the

Admission ID Input directly into the box
current patient
Bed number of the current

Bed No. Input directly into the box
patient
Clinical diagnosis of the Can select from the drop-down

Diagnosis
current patient box or enter data directly
Current patient's attending Can select from the drop-down

Doctor
physician box or enter data directly
Department where the current Can select from the drop-down

Send From
patient resides box or enter data directly
Physician who requested the Can select from the drop-down

Sender
current sample box or enter data directly
52
Can enter data directly or select

Test Time Time of sample testing
by clicking
Time of sample submission Can enter data directly or select

Send Time
by clicking
Physician responsible for Can select from the drop-down

Tester
testing the patient's sample box or enter data directly
Person making an audit and Can select from the drop-down

Reviewer
inspection report box or enter data directly
Indicates special Input directly

circumstances concerning the
Comments
present sample or other
related information
Click to save the patient's

OK Saves patient information
information
Cancels the registration of Click to return to the previous

Cancel
patient information screen
53
4.3.1.3. Introduction to Application Features

The Sample Request screen features a number of function buttons including sample blank
and repeated testing as well as dilution testing. The user can request each sample
independently based on their specific requirements; The user can also set default conditions
in order to perform default requests for all samples. After a corresponding default function is
checked, it becomes valid for all items, but can be modified manually.
Figure 4-9: "Sample Application" Screen Function Key Schematic
Each function button and a corresponding explanation is given below:
Button Explanation and Operation of Function
Sample Blank When checked, a sample blank test is requested by default
Indicates the number of times a test is repeated; can enter the

Repeat
desired number of repetitions after checking
Sample dilution test; can set the dilution parameters according to

Dilution
specific requirements
When checked, the system will automatically determine whether

Auto Dilution
or not the test results necessitate a dilution retest based on the
Rerun
automatic dilution rerun conditions specified.
Request Sample Test Request
54
Request List View already-requested samples and the project; can perform
delete operations
4.3.1.4. Sample Program

1) Enter the "Test Request - Sample Request" menu;
2) Select the sample disk number, sample position and sample type;
3) Enter the sample ID;
4) Choose whether or not the sample corresponds to an emergency or is a batch

sample and input detailed information according to actual clinical conditions;
5) Click the item that needs to be measured in the in the Chemistry List. Click once to
select and click again to cancel the selection. Or, click the specified combination in
the Panels Selection Screen. Click once to select and click again to cancel the
selection.
6) Click the "Request" button to open up a pop-up box;
7) View or delete application records in the request list.
4.3.1.5. Repeat Test

When requesting a sample, enter the number of times a given test is to be repeated into the
"Repeat" function selection for the relevant project. Takes effect once the request is successful.
4.3.1.6. Sample Blank

When requesting a sample, select whether or not to test a "Sample Blank" for the relevant
project. Takes effect once the request is successful.
4.3.1.7. Dilution Test

Dilution functionality is divided into automatic dilution and manual dilution. "Multiple" refers
to the factor by which the dilution is performed (also called the post-dilution factor). Must be
set to equal to or greater than 2; When performing an automatic dilution, the "Original
Sample Volume" which refers to the amount of original sample drawn by the Sample probe
during dilution, needs to be set. It is recommended when performing an automatic dilution
that the product of the dilution factor and the dilution amount falls between 200 - 400 ul, in
order to achieve the best dilution results; When performing a manual dilution, the user
should first dilute the sample, select manual dilution and enter the dilution factor. An
already-diluted sample is used to perform testing.
55
4.3.1.8. Auto Dilution Rerun

After selecting automatic dilution rerun functionality for a given project, the software will
evaluate the results according to the automatic dilution retest parameters specified in the
project parameters to ensure that an automatic dilution retest needs to be performed. Takes
effect after a request is successful.
4.3.2. QC Request
In the QC Request menu, the user can request quality control testing. Any of the preset
quality control items can be selected to request a test based on the user's specific
requirements. Both repeat testing and dilution testing functions can be tested; Quality
control application records can be viewed and deleted in the Request List menu.
Figure 4-10: "QC Request" Screen

For an explanation of the meanings of various "QC Request" screen parameters, consult the
following table:
Parameter Meaning
Selects the number of the sample disk for quality control testing (there
Disk
are 5 by default) via a drop-down box
Refers to the disk position number (total of 40 possible) of the selected
QC Position sample. The number can be entered directly or you can click on
the right of the screen to select a number from the sample disk empty
vial list
56
Parameter Meaning
QC ID Number of the QC sample; entered directly in ascending order
Refers to the quality control liquid which was been set; selected from a
Control
drop-down box

For an overview and explanation of the meanings of the "QC Request" screen functional
buttons, consult the following table:
Number of project test repetitions; enter the number of repetitions for a

Repeat
repeat test
QC dilution test; click Dilution and then select a dilution method and
Dilution
input the corresponding dilution parameters
Request Request QC Test
Setup Sets QC parameters; click to enter the QC setup interface
Request List List of quality control tests already requested; click to enter the list
viewer screen
4.3.2.3. QC Request
The basic QC request procedure is as follows:
1) Enter the "Test Request - QC Request" menu;
2) Select a disk number, QC position and control solution and enter the QC ID;
3) Click the item that needs to be measured. Click once to select and click again to
cancel the selection. Or, click the specified combination in the Panels Selection
Screen. Click once to select and click again to cancel the selection.
4) Choose whether or not to perform repeat testing and dilution testing based on the
actual requirements of the project;
5) Click the "Request" button after which the software should indicate that the request
was successful. View or delete application records in the request list.
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4.3.3. Calibration Request

A calibration test can be requested on the calibration request screen where the user can
also check the list of requests as well as set up the calibration.
Figure 4-11: The "Calibration Request" Screen

For an explanation of the meanings of various "Calibration Request" screen parameters,
consult the following table:
Button Meaning
Disk Sample disk number where the calibrator resides
Chemistry List Shows all items
Prev View the previous item list
Next View the next item list
Details Setup Detailed settings concerning the number of repetitions,

reagent blanks and calibrators for the calibration test; effective for
a single project
58

See the following table for explanations concerning the function of the various "Calibration
Request" buttons and the operation thereof:
Repeat Default number of calibration test repetitions; valid for all requests
Rgt Blk Default selection for reagent blank testing; valid for all projects
Setup Calibration Parameter Settings
Request Calibration Test Request
Request List List of calibration tests already requested; click to enter the list
viewer screen
4.3.3.3. Calibration Request

The basic calibration request procedure is as follows:
1) Enter the "Test Request - Calibration Request" menu;
2) Click the item that needs to be calibrated. Click once to select and click again to
cancel the selection.
3) Select the calibrator that needs to be tested in the detailed settings box on the right
hand side of the screen;
4) Set the number of calibration repetitions and the reagent blank in the detailed settings
box on the right hand side of the screen according to the needs of the project;
5) Click the "Request" button until the request is shown as successful;
6) View or delete application records in the request list.
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4.4. Online Status
The "Status" menu primarily shows information such as the current state of the sample disk,
reagent disk and reaction disk as well as tests currently being performed; The menu also
includes a test list submenu which shows the status of the invalid tests. These are described
in detail below.
4.4.1. Sample Disk Status

In the "Sample Disk" menu, you can view the test status and sample information of test
samples that have already been requested, as well as a list of requested items; additionally,
basic operations can be performed using this menu.
Different shapes and colors for a sample position on the disk on the left side of the Function
Display Area indicate different types of samples and different test statuses; The Sample
Information display box is shown in the upper right of the Function Display Area; shows
basic information regarding selected samples; A list of tests for the selected samples is
shown in the area below; The Estimated Time Remaining box shows the time required to
complete testing of the current sample batch.
The function key area includes Barcode Scan, Rerun, Release Positions, Release All, Add
and Reaction Curve function keys, allowing the user to select an appropriate action.
Figure 4-12: The "Sample Disk" Screen
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4.4.1.1. Status Explanation

For information concerning the meaning of various sample colors shown in the "Sample
Disk" screen, see the following table:
Status Color Meaning
Idle Blank Unoccupied position; can request a sample
To be tested Blue A sample has been requested but the test has not
been started
In Progress Pink Sample currently being tested
Finished Green All tests for the sample have been completed
Incomplete Yellow Test completed, but, due to various causes, a

result cannot be computed
Insufficient Red Insufficient sample margin

Sample
For the meanings of different sample position shapes in the Sample disk Status Screen
Function Display Area, see the table below:
Sample Position Meaning

Shape
Circle The sample is a standard sample
Triangle The sample is an emergency sample
Square The sample is a control solution
Pentagon The sample is a calibrator
Hexagon Deionized water is in the corresponding position
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For an explanation of the meanings of various "Sample disk Status" parameters, consult the
following table:
Parameter Meaning
Disk Current sample disk number
Information concerning the sample in the current sample position,

Sample
including sample position, number, test type, patient name, sample
Information
type and bar code information
Displays a list of tests, results and additional notes for the currently
Test List
selected sample

The "Sample disk" status screen includes Barcode Scan, Rerun, Release Positions,
Release All, Add and Reaction Curve function buttons (total of 7 buttons);
for a description of the function and basic operation of each button, see the table below:
Button Explanation of Basic Operation and Functions
Barcode Scan Click to enter the bar code scanning interface, select the location
you want to scan and the desired scan mode and, after verifying the
input, start scanning the sample
Rerun Select samples and items requiring a retest; click rerun button to
perform a repeat test
Release Release the location of the selected sample

Positions
Release All Release all samples on the current disk
Add Click after selecting a sample to enter the Sample Request screen
and add additional test items to already-requested samples
Reaction Curve After selecting a sample and test(s), click to view the corresponding
reaction curve(s)
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Notes:
1) The retest function can only be used for chemistries where testing has
already been completed;
2) Samples that are currently being tested cannot be deleted and

released;
3) Release of the entire disk can only be performed when the instrument
is stopped.
4.4.2. Reagent Disk Status

The status of all reagents can be viewed in the "Reagent Disk" screen, and operations such
as setting the reagent position and monitoring residual volume can be performed.
Figure 4-13: The "Reagent Disk" Screen
Detailed information corresponding to all reagent positions is shown in the left side of the
Function Display Area. Different colors indicate different reagent types and statuses as well
as other information; The Chemistry List Area on the right-hand side shows abbreviations for
all items and the user can page through the list using the Next and Previous buttons; The
two boxes on the lower right part of the screen show the position of the currently selected
reagent or detailed reagent classification, positioning and residual volume information
corresponding to the item currently selected; The different colored circles in the middle of
each reagent position indicate different reagent statuses: normal, insufficient reagent,
reagent depleted and expired.
The Function Key Area contains 6 major function keys: Barcode Scan, Inventory, Reset,
Release Positions, Release All and Reagent Status, which can be used to perform
corresponding operations.
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The meaning of various statuses and parameters which appear on the "Reagent Disk"
screen are as shown below:
Empty Blank The current reagent position is empty
Diluent Blue A dilute solution is in the corresponding position
R1 Light Green Reagent 1 is in the current position
R2 Orange Reagent 2 is in the current position
Shared Pink The current reagent position is shared by reagents

across multiple projects
Unrelated Yellow The current reagent position is not associated with

a project
In addition, the circle area in the center of a given reagent position will appear blank, yellow,
red or gray to indicate whether the reagent is normal, insufficient, completely depleted or
expired (4 possible states) respectively.

For the meanings of various parameters and operations associated with the "Reagent disk
Status" screen, refer to the following table:
Chemistry List List of abbreviations for all Move the mouse or click to make
items. Move the mouse or click a selection
to make a selection
Reagent Name Chem. Abbreviation Select an item in the item list
Exp Date Expiration date of the reagent Default is 1 year. Use the
drop-down box to select a date
Uncap Time The number of days remaining No action required. The software
until the reagent expires automatically calculates the
remaining number of days based
on the reagent's expiration date
Lot No. Lot Number Information for the The user need only enter the lot
Reagent Kit number information provided with
the reagent kit
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Volume Reagent bottle specification Inner Ring: Including two sizes:

40ml and 20ml, with 40 ml the
default size; the user can select
the corresponding size in the
drop-down box based on the
specification of the reagent used.
Outer Ring: Size is fixed at 20ml
and cannot be selected.
Remaining Refers to the number of days Blank by default; the user can set
until the reagent expires after a value as needed; The
the reagent bottle is opened. cumulative number of days
The number of days after the following opening of the reagent
reagent bottle is opened is bottle will be cleared after a
calculated from the time the refresh or residual volume
reagent position is set. detection operation is performed,
and the calculation of the number
of days following opening of the
reagent bottle is restarted.
Diluent Set this position as diluent First click one position, and then
position tick the check box and input
related information, save.

It is possible to perform 7 major functions in the Reagent disk Status Screen: reagent
position setup, barcode scan, residual volume detection, residual volume reset, release
position, release of the entire disk and reagent status view.
4.4.2.4. Reagent Position Settings

1) Left-click to select a reagent bottle position;
2) Move the mouse to the item that needs to be set in the item list area;
3) In the dialog box that pops up, select the reagent category that you wish to set:
R1 or R2;
4) Reagent Information Settings Name is displayed by default by the system based

on the project and reagent type selected. Specifications, expiration date, time to
expiration after opening, residual volume and number of days remaining are set to
their default values when set up for the first time and any of these parameters can
be adjusted manually according to the needs of the user;
65
Figure 4-14: The "Reagent State disk - Reagent Information" Screen
5) Click on the Save button in the reagent information box to save the corresponding
reagent information;
Notes:
1) The two reagent items R1 and R2 must be set to the same reagent
disk;
2) When a change in reagent location is necessary, the user need only

release the reagent position (for specific operating instructions, see
"Release Position").
4.4.2.5. Reagents Scan

1) Click the "Barcode Scan" button;
2) In the pop-up dialog box, select the position you want to scan and click on the "OK"
button or click "Cancel" to exit.
4.4.2.6. Inventory
1) Select the reagent disk;
2) Click the " Inventory " button to open up the residual volume detection interface;
3) Choose the reagent for which residual volume detection needs to be performed;
4) Click the "OK" button to start residual volume detection or click the "Cancel" button
to cancel residual volume detection.
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Notes:
Reagent residual volume monitoring can only be performed in standby mode.
4.4.2.7. Reset Volume

1) Select the reagent position that needs to be reset in the Reagent disk Screen on
the left;
2) Click the "Reset " button to reset the reagent residual volume and expiration date;
3) If you need to reset residual volumes for all reagents or residual volumes for
multiple reagents;
4) First, left-click on the chemistry list area;
5) Click the "Reset " button to bring up the following screen:
Figure 4-15: The "Reset" Screen
6) Select items that need to be reset. If all items need to be refreshed, click "Select All"
7) Click the "Reset" button to reset the residual volume and expiration date of the
reagent corresponding to the selected item. Once the reset is successful, a status
message will pop up;
8) Otherwise, click the "Back" button to cancel resetting the residual volume.
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Notes:
When an item is missing a reagent, a residual volume reset must be
performed after adding the required reagent before the testing with the
reagent can be performed.
4.4.2.8. Release Positions

1) Select the reagent disk number;
2) Click on a reagent in the reagent disk that requires a position change and click
"release position" to release the reagent position;
3) Click Whole disk Release to release all positions on the reagent disk.
Notes:
The release of a reagent position is not permitted for items still undergoing
testing and the instrument does not allow a whole disk release to be
performed when in testing mode.
4.4.2.9. Reagent Status

Click the "Reagent Status" button to open the Reagent Status screen and see detailed
information regarding all reagents on the reagent disk, including their positions, lot numbers,
residual volumes, number of viable tests, expiration dates, reagent specifications, and
calibration status for corresponding items; it is possible to perform residual volume detection
and reset operations on this screen. Enter the appropriate conditions in the filter conditions
box and the system will automatically filter for reagents which meet the conditions specified,
allowing for easy examination and operation of reagents.
Figure 4-16: The "Reagent Status" Screen
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4.4.3. Reaction Disk Status

Enter the "Reaction Disk" screen from "Online Status" to view the overall condition of the
reaction disk as well as the status of reaction cuvettes. Colors are used to display in
real-time the current status of each reaction cuvette, including the cleaning status and
sample loading status of each reaction cuvette as well as observe the reaction curve of valid
tests (samples, calibration, quality control, sample blank and reagent blank); Clicking on a
reaction cuvette will display testing information for the location indicated on the right-hand
side of the screen.
Figure 4-17: The "Reaction Disk" Screen

There are a total of 10 different reaction cuvette statuses which may be displayed in the
"Reaction Disk" screen, different colors are used to display the current status of each
reaction cuvette in real time and status information displayed in the center of the virtual
reaction disk schematic includes the following:
Idle Blank Clean cuvette - can be used for a new test
To be Dark For analyzer with auto wash function only. Indicates

cleaned Gray cuvettes that have not been cleaned or reserved
immediately following startup of the device; a cleaning
operation may be performed on cuvettes of this type
69
Cleaning Brown For analyzer with auto wash function only. The cuvette is
currently undergoing cleaning and once cleaning is
completed a cuvette blank test can be used to determine
whether the cuvette is clean or dirty
Dirty Dark The cuvette is not clean, or the cuvette is already occupied
cuvette Red with waste product (e.g. voided test)
Dilution Blue Dilution is currently being performed in the current cuvette

position
R1 Light Addition of a first reagent for a given test

Green
S Dark Addition of a sample for a given test

Blue
R2 Orange Addition of a second reagent for a given test
End Yellow The current test ended normally and the corresponding
results have been computed

For an explanation of the meanings of various "Reaction Disk" parameters, consult the
following table:
Parameter Meaning
ID Cuvette number
Test Type Automatically displays the type of test corresponding to the

selected cuvette, including calibration, quality control,
sample tests, sample blank, reagent blank and dilution
(total of 6 classes)
Sample Pos. Position of the sample corresponding to the current test
Abbreviation for the test being carried out in the reaction

Chem
cuvette
Conc Results of the test being carried out in the reaction cuvette
Indicates whether or not the current test is a retest; if so,

Rerun
a mark is displayed in the box
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Parameter Meaning
The time to completion for tests carried out in the selected

Finish Time
reaction cuvettes
Shows error information related to testing performed in the

Comments
selected cuvette

For an explanation of the functions and basic operation of buttons on the "Reaction disk
Status" screen, see the following table:
Button Explanation of Basic Operation and Functions
Reaction Curve Select a reaction cuvette on the reaction disk which

is currently undergoing testing during a cyclical test and
click on it
This button will call up a "Reaction Curve" screen which

shows the reaction curve for tests performed in the
reaction cuvette
Notes: When the selected reaction cuvette contains a

diluted sample or is empty, this button is disabled.
Replace Cuvette For analyzer without auto wash function only. After
replacing new cuvettes, click this button so that the system
will detect and refresh the cuvette status.
4.4.4. Test List

You can view information for tests that are invalidated.
71
Figure 4-18: The "Test List" Screen
4.4.4.1. Explanation of Status and Functions

When a test is listed as invalid, a retest can be performed. Details regarding each status are
given in the table below:
Status Description of Status and Functions
Invalidated An item for which the corresponding test was rendered invalid
due to an error such as malfunction or lack of samples /
reagents; the user can select the corresponding item and initiate
a retest as needed
4.5. Query Results
The Query Results screen allows the user to query sample, calibration, quality control and
reagent blank results. These will be described in the following section.
4.5.1. Sample Result Query

The left side of the Function Display Area on the Sample Result Query Screen shows
sample records which meet the current query criteria (samples for the current day are
displayed by default) including request time, sample ID, sample position, patient name and
barcode; Detailed information corresponding to the sample is shown in the upper right
section of the screen. The contents of this information are identical to the "Test Request -
Sample Request" screen and can be edited and saved for later; A list of tests for the
selected samples is shown in the lower right section of the screen;
72
Figure 4-19: The "Sample Result Query" Screen

Queried sample results can be arranged based on sample or based on corresponding item.
The sample-based view includes multiple function buttons, including search, delete sample
and delete chem allowing the user perform corresponding operations.
4.5.1.2. Search Conditions

By default, the Sample Results Query interface displays a record of tests performed on the
current day. If you need to check older results, click the "Search" button to bring up the
"Sample Query" dialog box and, after entering your query criteria, a corresponding sample
record should be displayed; Click "Close" to end the query.
Figure 4-20: The "Sample Query Criteria" Screen
73
4.5.1.3. Delete Sample

Select the sample you want to delete, click the "Delete Sample" button to bring up the
confirm deletion prompt and confirm the deletion.
Notes:
Samples that are currently being tested cannot be subject to a "Delete
Sample" operation.
4.5.1.4. Delete Chem

Select the sample that needs to be deleted and select the items you want to delete from the
Item List Area. Then, click the "Delete Chem" button to bring up the confirm deletion prompt
and confirm the deletion.
Notes:
Samples that are currently being tested cannot be subject to a "Delete
Chem" operation.
4.5.1.5. Rerun
Select the item requiring a retest to bring up the retest confirmation prompt and click "Yes" to
start a retest or click "No" to cancel.
Notes:
Only unreleased items for which testing has been completed may be
subject to a retest; unreleased samples include "samples requested on the
same day as well as samples requested on a previous day but which were
saved and not released from the sample disk as a result of not exiting the
software for an extended period of time."
4.5.1.6. Recalculate
"Recalculate" allows you to recalculate results and you can recalculate test results under
various conditions depending on your needs.
4.5.1.7. Preview / Print

After selecting a sample, click on "Preview" to display the results of the current sample and
print a preview image; Click Print to print the results directly.
4.5.1.8. LIS Send

After selecting a sample, click on LIS Send to directly send the selected sample results to an
LIS system.
4.5.1.9. Reaction Curve

After selecting a sample and test item, click the "Reaction Curve" button to bring up the
74
reaction curve corresponding to the current results record.
4.5.1.10. By Chem
Click the "By Chem" button to enter the View Results by Item screen which includes the
following 5 functional buttons: Search, Delete Chem, Recalculate, By sample and Results
chart. The Search, Delete Chem, Recalculate and Results chart are functionally equivalent
to corresponding features of the View By Sample screen and the View By Sample screen
allows the user to switch to viewing the results by sample.
Figure 4-21: The "Sample Results Query - View by Chem" Screen
4.5.2. Quality Control Result Query

The Quality Control Results Query function provides three quality control modes: real-time QC,
Daily QC, and Day-to-day QC. A detailed explanation of quality control modes is given in
Section 6.6.2; Provides three different quality control chart types: Westgard, Cum-sum-check
and Twin Plot; Quality control data can be displayed by either quality control or item.
75
Figure 4-22: The "Quality Control Result Query" Screen

For explanations of different parameters and operations corresponding to the "QC Result
Query" screen, see the following table:
Parameter Explanation and Operation of Parameters
Select Provides three quality control modes: real-time QC, Daily QC,
and Day-to-day QC; can be selected directly
Date Date on which quality control data needs to be examined;

can be selected directly
Chemistry List of abbreviations for quality control items; can directly

select the desired item; when nothing is selected, defaults to
showing quality control data for all items
Control List of control solutions; can be selected and viewed directly
Westgard Click to view a quality control chart created based on quality

control data for the selected project and within the selected
time period based on preset Westgard quality control rules.
Cum-sum-check Click to view a quality control chart created based on quality

control data for the selected project and within the selected time
period based on pre-set cumulative sum quality control rules.
Twin Plot Click to view a twin plot chart created based on quality
control data for the selected project and within the selected
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Parameter Explanation and Operation of Parameters
time period.
QC Data Click to display quality control data filtered based on specific

quality control conditions.

For explanations regarding the function of buttons on the "QC Result Query" screen as well
as the operation thereof, see the following table:
Search Click directly to query corresponding quality control data

based on the conditions selected
Default Quality control data is selected by default - the system

automatically treats the last successful result for a given day
and a given item as the default result. When there are
multiple successful results for a given day, the default result
can be selected manually
Preview Click to initiate a print preview of quality control data and

corresponding quality control charts
Print Click to print quality control data and corresponding quality

control charts
Save Graph Saves the quality control chart
Delete Delete quality control data. Click after selecting the data you
would like to delete. By default, quality control data cannot
be deleted
LIS Send Send quality control data to a LIS system
Reaction Curve Click to view reaction curves corresponding to the selected

quality control test results
4.5.2.3. Quality Control Result Query

1) Select the type of quality control you want to view on the left-hand side and select
the start and end dates you wish to query;
2) Select the desired item and control solution name and the system will automatically
77
bring up the corresponding quality control data;
3) Select the "Quality Control Data" menu to show all test results for the current item
for the selected time period;
4) Select the "Westgard", "Cum-sum-check" or "Twin Plot" menu to view the

corresponding chart for the given item and time period
4.5.3. Calibration Result Query

After selecting an item in the Calibration Results Query menu, enter the appropriate date
and the system will automatically find calibration records for all items. Furthermore,
functions such as blank correction and calibration copying can be invoked as needed.
Figure 4-23: The "Calibration Result Query" Screen

For explanations of different parameters and operations corresponding to the "Calibration
Result Query" screen, see the following table:
Parameter Meaning and Basic Operation
Routine Chemistry List Shows all standard items directly. Directly select the item
you wish to view
Cal Date The date of the calibration data you wish to view.
Directly selected
Cal Time Time at which the calibration test was requested
Method Calibration method for the current item
Status The recorded status of each calibration. Can be either

"test complete" or "request pending"
78
Parameter Meaning and Basic Operation
Default Signs the current default calibration results
Rgt Blk Reagent blank data used during calibration
Calibration Parameter Displays calibration parameters derived from linear

calibration results

Using the Calibration Results Query screen, you can view the calibration results for each
item. Five buttons - blank correction, calibration copy, Send to LIS, delete and calibration
curves - are available on this screen for performing corresponding functions.
4.5.3.3. Blank Correction

Click "Blank Correction" to bring up a dialog box and, after selecting the appropriate date,
check the reagent blank results. Select the reagent blank that needs to be used for the
correction and click "Correction" to start the correction process; Click "Close" to exit.
Figure 4-24: The "Blank Correction" Function Screen
4.5.3.4. Copy Cal

Select the calibration results that need to be replicated, click on the "Copy Cal" button to
bring up the "Copy Calibration Data" dialog box, select the target item to which you want to
copy the calibration parameters, click "reset" and make another selection, click "Copy" to
start the copying process and click "Close" to exit.
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Figure 4-25: The "Copy Calibration" Function Screen
4.5.3.5. Delete
Directly delete the selected calibration results; default results cannot be deleted.
4.5.3.6. Send to LIS

Users can use this function when an LIS connection is present. Click to send data to a
connected LIS system.
4.5.3.7. Calibration Curve

Select record corresponding to a single instance of successful calibration, click on
"Calibration Curve" to view the calibration curve corresponding to the selected result as
shown in the Figure below:
Figure 4-26: The "Calibration Curve" Screen
80
Using the Calibration Curve interface, you can take advantage of functions such as modify
calibration parameters, recalculate, save parameter, print graphic, save graphic and view
reaction curve view. See the following table for explanations concerning the function of the
various buttons:
Recalculate Using existing calibration data, you can choose different calibration
methods to recalculate calibration parameters. Click directly to use.
Notes: The use of different calibration methods to

recalculate calibration parameters is predicated on existing
calibration data meeting the computational conditions of the
method used to recalculate the calibration.
Save parameters Saves new calibration parameters after calibration curve
parameters have been modified or a recalculation has been
performed
Print Image Prints a calibration curve
Save Image Saves a calibration curve
Reaction Curve Click to view reaction curves corresponding to the selected
calibration test results
Close Closes the current screen. Click directly to close
4.5.4. Reagent Blank Query

While querying a reagent blank, it is possible to view reagent blank results and a reagent
blank trend graph on an item-by-item basis.
Figure 4-27: The "Reagent Blank" Screen
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4.5.4.1. Basic Operation:

1) In the chemistry list box, select the chemistries you wish to query;
2) Choose the start and end dates of the reagent blank you wish to query;
3) The system will automatically find corresponding reagent blank data and produce a
trend graph.

For explanations regarding the function of buttons on the "Reagent Blank Query" screen as
well as the operation thereof, see the following table:
Print Data Prints reagent blank data found under the current query.
Click to use
Save Graph Saves the reagent blank trend graph. Click to use
Print Graph Prints the reagent blank trend graph. Click to use
Delete Deletes reagent blank data. Select the data you wish to delete
and click to delete
Notes: Default reagent blank data cannot be deleted
Reaction Curve View a reaction curve corresponding to the selected reagent

blank results. Click to view
4.6. Para. Setup

Includes the Routine Chemistry, Calculation Chemistry, Panels, Carryover, ISE Settings,
Calibrator Setup and QC Setup menus. Each menu can be used to invoke corresponding
functions.
4.6.1. Routine Chemistry

When including basic parameters, monitoring parameters, QC parameters and standard item
parameter settings, setting are performed preferentially in the following order: ―Basic Parameters‖
→ ―Monitoring Parameters‖ → ―QC Parameters‖. These are described in detail below:
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4.6.1.1. Basic Parameters
Figure 4-28: Parameter Settings Screen #1
Introduction of Basic Parameters

For explanations of different parameters and operations corresponding to the "Basic
Parameters" screen, see the following table:
Chemistry Item abbreviations Data can be entered directly into the input box.
Supports entry of up to 20 English characters
or 20 Chinese characters (supports the input
of any characters, including special characters
such as punctuation and Greek letters)
Full name The full name of Data can be entered directly into the input box.
the item Supports entry of up to 20 English characters
or 20 Chinese characters (supports the input
of any characters, including special characters
such as punctuation and Greek letters)
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Decimal Number of decimal Can select one of five settings from the drop
places with which down box: 0, 0.0, 0.00, 0.000 and ...
results are saved
Select the ... button to enter the "Data Dictionary
Maintenance" menu and click on the "Add"
button. You can specify any number of decimal
places with which results will be retained. Click
the "Save" button once you have finished editing
your selection to save or click "Cancel" if you do
not need to save your selection
Test Method Sets the measurement Select from the drop-down box. The following
method for a given item five options are available: end-point method A,
end-point method B, end-point method C,
two-point method and kinetic method
Direction The direction of any Select from the drop-down box. There are two
change in absorbance options: increase and decrease
which occurs during
the reaction
Unit Units of the test results Selected from a drop-down box
Select the ... button to enter the "Data

Dictionary Maintenance" menu and click on
the "Add" button. You can specify any number
of decimal places. Click the "Save" button
once you have finished editing your selection
to save or click "Cancel" if you do not need to
save your selection
Pri Wave Main wavelength of the Select from the drop-down box. Eight
measurement wavelengths are available: 340, 405, 450,
510, 546, 578, 630 and 670 nm
Sec Wave Secondary wavelength Select from the drop-down box. Eight
of the measurement wavelengths are available: 340, 405, 450, 510,
546, 578, 630 and 670 nm
Linearity Linear range of the Directly enter the upper and lower concentration
Range reagent kit limits for the reagent's linear range as indicated
in the reagent kit instructions
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Calibration Set the calibration Select from the drop-down box. There are ten
Method method for a given item options available: K-factor method, linear
scaling, Logistic-Log4P, Logistic-Log5P,
Exponential-5P, Polynomial-3P, Polynomial-4P,
Polynomial-5P, spline and Com4P
If you choose the K-factor method, you will
also have to enter specific corresponding
K-factor values in the corresponding box
Click on the "Details" button to edit specific
calibration parameters, including the repeated
measurements differential limit, blank solution
reaction range, calibration sensitivity, calibration
curve standard deviation and calibration curve
correlation coefficient. If you need to save your
changes after editing is complete click on the
"OK" button or click "Cancel" if you do not wish
to save your changes
Reagent Number of remaining Input directly into the box. During test once the
Alarm No. tests for a given remaining reagent is less than the number
reagent kit input, an alarm will come up.
Sample The amount of sample Enter values directly into the box. Entries can
Volume loaded for a normal range from 2 - 50 μl and can be adjusted in
test. Value is 0.1 μl increments
expressed in units of
microliters
R1 The amount of Reagent Enter values directly into the box. Entries can
1 loaded for a normal range from 150 - 450 μl and can be adjusted in
test. Value is 1 μl increments
microliters
R2 The amount of Reagent Enter values directly into the box. Entries can
2 loaded for a normal range from 10 - 300 μl and can be adjusted in
test. Value is 1 μl increments
microliters
85
Blank Cycle / The blank cycle time. Input directly into the box
Time (s) For a single reagent,
this refers to the cycle
time before the sample
is loaded while for two
reagents this refers to
the cycle time after the
sample is loaded prior
to the loading of R2
Reaction Used for computed Input directly into the box

Cycle / Time (s) optical metering start
and end points
Cost Cost of the item Input directly into the box
Price Item price Input directly into the box
Modified Uses the formula y = Enter directly into the box, 1 by default
Slope ax + b to correct
measurement results,
where x is the actual
measured result, y is
the corrected result, a
is the slope of the
correction formula and
b is the intercept of the
correction formula
Offset Enter directly into the box, 0 by default
Ref Lower Enter the default Enter a number in the box based on the
Limit lower limit of the reference range provided by the reagent's
reference range manual or other professional reference book
Ref Upper Enter the default Enter a number in the box based on the
reference range provided by the reagent's
Limit upper limit of the
manual or other professional reference book
reference range
Click "+" to set the upper and lower limits of
the reference range; Click "-" to delete all
content related to the reference range;
Click " " to add additional conditions for a
reference range, including classification,
gender, sample type, age lower limit, age
upper limit, and age units
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Import Imports item-related Click the "Import" button, select item-related

parameters from an parameters you want to import and initiate the
external source import operation
Export all Exports all current Click the "Export All" button to export all
item-related item-related parameters to an external
parameters storage device
Selectively Select a subset of Click the "Selectively Export" button to export

export available item-related a subset of available item-related parameters
parameters for export to an external storage device
Enable Disable the selected Select the disabled item that you want to
item active. Click the "Enable" button to activate the
item.
Disable Enable the selected Select the item that you want to diable. Click
item the "Disable" button to diable the item.
Basic Operations
Add Item Parameters

1) Click the "Add" button;
2) Enter parameter data directly into the corresponding item parameter box or make a
selection from the drop-down box;
3) If you need to save the data after completing the above, click the "Save" button,
or click the "Cancel" button if you do not wish to save your data.
Change Item Parameters
1) Select the item you wish to modify in the list of standard items;
2) Click the " Modify " button to modify parameter data for the current project;
Delete Item Parameters
1) Select the item you wish to delete from the list of standard items;
2) Click the "Delete" button to open up a warning dialog box ("Are you sure you want
to delete the currently-selected standard project(s)?")and click the "Yes" button to
delete the item or click "No" to cancel deletion of the item.
Note: have tested data items not allowed to delete.
87
4.6.1.2. Monitoring Parameters
Introduction of Monitoring Parameters
For explanations of different parameters and operations corresponding to the "Standard

Item Settings" screen, see the following table:
Linearity Limit (%) Determines the linearity of Enter an integer value between
the reaction curve. Only 0 - 100
used for the kinetic method
Substrate Depletion The limit set to determine Enter an integer value between
Limit substrate depletion during -40000 - 40000
the reaction process. Must
be an absorbance value
multiplied by 10000. Only
used for the kinetic method
and two-point method
Enzyme Linear When the optical metering Place a √ in the selection box or
Extension point in a zero-order kinetics click the √ to cancel your selection
interval is n ≤ 2, enzyme
linear range expansion
functionality can be activated
to calculate the reaction rate
based on all optical metering
point data for which substrate
depletion has not occurred,
including delay times
88
(⊿ Amax) as an indicator of
the sample's reactivity
Prozone Check Prozone check limit Enter an integer value between

PC value 0 and 100
Reaction time optical
LMNP metering point Enter a corresponding optical
metering point in accordance with
the instructions contained in the
section on the specific prozone
check PC value algorithm
R1 Abs Range Enter the lower / upper limits Enter specific values between
of the first reagent's -40000 and 40000 directly into the
absorbance. Values must be box without exceeding the upper
absorbance values absorbance limit for the first reagent
multiplied by 10000.
Working Solution Enter the lower / upper limits Enter specific values between
Abs Range of the working solution's -40000 and 40000 directly into the
absorbance. Values must be box without exceeding the upper
absorbance values absorbance limit for the working
multiplied by 10000. solution
Response Range Reaction amplitudes In the box, enter a specific value

corresponding to the upper between -40000 and 40000
and lower limits of the linear
range. Values must be
absorbance values
multiplied by 10000.
Auto Dilution Rerun Includes Above Linearity Place a √ in the selection box or
Conditions Upper Limit, Above Linearity click the √ to cancel your selection
Limit, Above Substrate
Depletion Limit and Above
Prozone Check Limit
Auto Dilution Rerun Includes dilution factor and Enter specific values in the box
Setup stock liquid dosage
Calibration Validity The valid period of Input the defined number and select
calibration a unit
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Basic Operations
Set or Modify Monitoring Parameters
1) Select the item you wish to set or modify in the list of standard items;
2) Enter corresponding data into each monitoring parameter input box;
3) If you need to save the data after completing the above, click the "Save" button, or
click the "Cancel" button if you do not wish to save your data.
4.6.1.3. QC Parameters
Explanation of QC Parameters
For explanations of different parameters and operations corresponding to the "QC

Parameters" screen, see the following table:
Westgard QC rules Set an item's Westgard multi-rule Select a rule by checking it.
quality control
Description Explanation of the conditions for No operation

determining whether or not a loss
of control has occurred under the
Westgard rules
Conclusion Indicates determination regarding No operation

sources of error for Westgard
loss-of-control rules. Should only
90
be used as a guide
Cumulative Sum Set an item's cumulative sum Select directly from the
Check quality control rules drop-down box
Basic Operations
Set or Modify Quality Control Parameters
1) Select the item you wish to set or modify in the list of standard items;
2) Select or modify Westgard multi-rule quality control rules;
3) Select or modify cumulative sum quality control rules;
4.6.2. Calculation Chemistry
Figure 4-31: "Calculation Chemistry" Parameter Settings Screen
4.6.2.1. Explanation of Basic Parameters

For parameter meanings and basic operations associated with the Computational Item
menu, see the following table:
Chemistry Item abbreviations Data can be entered directly into the input
box. Supports entry of up to 20 English
91

characters or 20 Chinese characters
(supports the input of any characters,
including special characters such as
punctuation and Greek letters)
Full name The full name of the item Data can be entered directly into the input
box. Supports entry of up to 20 English
characters or 20 Chinese characters
(supports the input of any characters,
including special characters such as
Unit Units of the test results Select the ... button from the drop-down
menu to enter the "Data Dictionary
Maintenance" menu and click on the "Add"
button. You can specify any kind of result
units as desired. Click the "Save" button
once you have finished editing your selection
to save or click "Cancel" if you do not need to
save your selection
Ref Range Enter the default Enter a specific value in the box based on
reference range the reference range provided by the
reagent's manual or other professional
reference book
Decimal Number of decimal places Users can select one of five settings from the
with which results are drop down box: 0, 0.0, 0.00, 0.000 and ...
saved
Select the ... button to enter the "Data
Dictionary Maintenance" menu and click on
the "Add" button. You can specify any
number of decimal places with which results
will be retained. Click the "Save" button once
you have finished editing your selection to
save or click "Cancel" if you do not need to
save your selection
Cost Cost of the item Input directly into the box
Price Item price Input directly into the box
Formula Use the Formula Editor Input directly into the box
area buttons and
calculation formula criteria
to complete formula
editing operations.
4.6.2.2. Basic Operations

Add Computational Item
92
2) Enter or select parameter data corresponding to the current computational and

use the Formula Editor area buttons and calculation formula criteria to complete
the expression
Modify Computational Item
1) Select the item you wish to modify in the list of computational items;
2) Click the "Modify" button to modify corresponding parameter data for the current
item;
Delete Computational Item
1) Select the item you wish to delete from the list of computational items;
2) Click the "Delete" button to open up a warning dialog box ("Delete current
calculation chemistry?") and click the "Yes" button to delete the item or click "No" to
cancel deletion of the item.
4.6.3. Panels
Figure 4-32: "Panels" Parameter Settings Screen
93
Chemistry Panel Data can be entered directly into the input box.
abbreviations Supports entry of up to 20 English characters or 20
Chinese characters (supports the input of any
characters, including special characters such as
Full name Panel full names Data can be entered directly into the input box.
Supports entry of up to 20 English characters or 20
Chinese characters (supports the input of any
characters, including special characters such as

Add Panel
2) Select the desired panel from the standard item and computational item lists;
Modify Panel
1) Select the panel you wish to modify in the list of panels;
2) Click the " Modify " button to modify items corresponding to the current panel;
Delete Panel
1) Select the panel you wish to delete from the list of panels;
2) Click the "Delete" button to open up a warning dialog box ("Delete current panel?")
and click the "Yes" button to delete the item or click "No" to cancel deletion of the
item.
94
4.6.4. Carryover
Figure 4-33: "Carryover" Parameter Settings Screen
4.6.4.1. Explanation of Basic Operations

For explanations of different parameters and operations corresponding to the "Carryover "
Contaminator Contamination source item Input directly into the box

abbreviations
Contaminated Contaminated item Input directly into the box

abbreviations

Carryover Settings
1) Select a contaminator from the contamination source item list and enter the item
abbreviation in the box to quickly find the item;
2) Select a contaminated item from the contaminated item list and enter the item
abbreviation in the box to quickly find the item; once a selection has been made
place a √ in the box next to the reagent class. If there is contamination of the
reaction cuvette, place a √ in the box next to "Contaminated Cuvette". Once
complete, click the "Save" button;
3) If you need to modify or delete a cross-contamination pair that has already been
set, select a contaminator from the contamination source item list, remove the √ in
the box next to the reagent class for the contaminated item and, once complete,
95
click the "Save" button.
4.6.5. Calibrator Setup
Figure 4-34: "Calibrator Setup" Screen

For explanations of different parameters and operations corresponding to the "Calibrator
Setup" screen, see the following table:
Name Name of the calibrator Input directly into the box
Sample Position The position of the calibrator Select the ... button to enter the
on the sample disk sample tray status and select a
sample position in which to place to
the selected calibrator
Lot No. Lot number of the calibrator Input directly into the box
Decap Date Date on which the calibrator Select by clicking on the calendar
was opened and a solution icon to the right of the box
was prepared
Expired Date Calibrator expiration date Select by clicking on the calendar
icon to the right of the box
96

Barcode Barcode of the calibrator Enter directly in the box or click on
the "Scan" button in the sample disk
screen to display directly

Add calibrator, Set project calibrator concentration, Set project calibrator
dilution factor
1) Click "+" to set the dilution factor and dosage for the item corresponding to the
current calibrator; Click "-" to delete the dilution factor and dosage for the item
corresponding to the current calibrator;
3) When finished, click the "Close" button to exit the calibrator setup screen.
Modify a Calibrator
1) Select the calibrator that you want to modify from the calibrator name list;
2) Click the "Modify" button to modify information corresponding to the current
calibrator;
4) When finished, click the "Close" button to exit the calibrator settings screen.
Delete a Calibrator
1) Select the calibrator that you want to delete from the calibrator name list;
2) Click the "Delete" button to open up a warning dialog box ("Delete selected
calibrator?") and click the "Yes" button to delete the calibrator or click "No" to
cancel deletion of the calibrator.
3) When finished, click the "Close" button to exit the calibrator setup screen.
97
4.6.6. QC Setup
Figure 4-35: The "QC Setup" Screen

For explanations of different parameters and operations corresponding to the "QC Setup"
Name of the quality

Control Input directly into the box
control solution
Type Type of quality control Selected from a drop-down box

solution, including serum,
plasma, urine and
cerebrospinal fluid
Lot No. Lot number of the quality Input directly into the box
control solution
Exp Date Expiration date of the QC Select by clicking on the calendar icon to
solution the right of the box
Days Left The number of remaining Enter the expiration date of the QC
days until QC solution solution and the system will automatically
expires display the number of days remaining until
expiration
98
Barcode QC solution lot number Enter directly in the box or click on the
"Scan" button in the sample disk screen
to display directly
Target Target value for item Input directly into the box
corresponding to a given
calibrator
SD Standard deviation Input directly into the box

value for item
corresponding to a
given calibrator

Add a quality control solution or set the quality control solution concentration for a
given item
2) Set parameter information corresponding to a control solution;
3) Enter a target value and standard deviation value in the target value and standard
deviation fields which follow the same of the item corresponding to the current
quality control solution;
5) When finished, click the "Close" button to exit the QC Setup screen.
Modify a Calibrator
1) Select the QC solution that you want to modify from the QC solution list;
2) Click the "Modify" button to modify information corresponding to the current quality
control solution;
4) When finished, click the "Close" button to exit the QC Setup screen.
Delete a Calibrator
1) Select the quality control solution that you want to delete from the quality control
solution list;
2) Click the "Delete" button to open up a warning dialog box ("Delete selected
control?") and click the "Yes" button to delete the quality control solution or click
99
"No" to cancel deletion of the quality control solution.
3) When finished, click the "Close" button to exit the quality control solution
settings screen.
4.7. Statistical Reports
Includes four subsections: test statistics, workload statistics, charge statistics and result
statistics. These will be described in detail in corresponding chapters.
4.7.1. Test Statistics

The "Test Statistics" menu is as shown below:
Figure 4-36: The "Test Statistics" Screen

For explanations of different parameters and operations corresponding to the "Test
Statistics" screen, see the following table:
Select Includes "By Chemistry", "By Sample", "By No operation

QC", "By Calibration"
By Generates statistics concerning the amount of Click the circle next to

Chemistry tests performed, number of tests completed, R1 the item statistics option
consumption and R2 consumption for each item until it turns blue
over a requested period of time as well as totals
for tests performed, number of tests completed,
R1 consumption and R2 consumption across all
items
100
By Sample Generates statistics concerning the amount of Click the circle next to
samples processed, number of items processed, the item statistics option
number of tests completed, statistical items, until it turns blue
manual items and ISE items for each day over a
requested period of time as totals for tests
performed, number of tests completed, R1
consumption and R2 consumption across all days
Request Generates statistics concerning a requested date Select by clicking on the

Date range with the range set to the current day only calendar icon to the
by default. Enter the start date in the first box and right of the box
the end date in the second box. The start date
cannot be later than the end date.

Statistics
Allows the user to check data for test statistics according to the statistical criteria entered.
Print
Prints a test statistics information table.
4.7.2. Workload Statistics

"Workload Statistics" are used to evaluate the user's workload with respect to a specific
physician or department.
Figure 4-37: The "Workload Statistics" Screen

For explanations of different parameters and operations corresponding to the "Workload
101
Select Includes "By Tester" and "By Sender" No operation
By Tester Selects Examining Physician Statistics. If nothing Click the circle next
is entered into the boxes corresponding to the to the item statistics
examining department and the examining option until it turns
physician, then the total workload of all examining blue
physicians in the examining department will be
computed; When an examining physician is
entered into the box corresponding to the
examining physician, then only the workload of
the physician in question is computed
By Sender Selects Submitting Physician Statistics. If Click the circle

nothing is entered into the boxes corresponding next to the item
to the submitting department and the submitting statistics option until
physician, then the total workload of all it turns blue
submitting physicians not in the examining
department will be computed; If a department is
entered into the box corresponding to the
submitting department, then the total workload
of all submitting physicians in the indicated
department will be computed; If both a
submitting department and submitting physician
are entered into the corresponding boxes, then
the total workload of the indicated physician in
the indicated department will be computed;
Request Date Generates statistics concerning a requested Select by clicking on

date range with the range set to the current day the calendar icon to
only by default. Enter the start date in the first the right of the box
box and the end date in the second box. The
start date cannot be later than the end date.

 Statistics
Allows the user to check data related to workload statistics according to the statistical
criteria entered.
 Print
Prints a workload statistics information table.
4.7.3. Charge Statistics

The "Charge Statistics" menu is shown below:
102
Figure 4-38: The "Charge Statistics" Screen

An explanation of basic parameters found in the "Charge Statistics" menu is provided in the
following table:

Select Includes "patient cost statistics" and "cost No operation
accounting statistics." Cost statistics include the
number of items, number of items completed,
total costs, total receipts, and total revenue
By Price Selects the patient cost statistics. A range of Click the circle next to
sample serial numbers to be incorporated in the item statistics
patient cost statistics needs to be set. option until it turns blue
By Cost Selects cost accounting statistics. The user must Click the circle next to
set items included in cost account statistics the item statistics
option until it turns blue
Request Date Generates statistics concerning a requested Select by clicking on
date range with the range set to the current the calendar icon to the
day only by default. Enter the starting day in right of the box
the first box and the ending day in the second
box. The starting date cannot be later than the
ending date.
Sample ID Test sample serial number range. Input directly into
the box
Item Name of the test item Selected from a
drop-down box

 Statistics
103
Allows the user to check data for charge statistics according to the statistical condition
entered.
 Print
Prints a costs statistics information table.
4.7.4. Result Statistics

The "Result Statistics" menu is shown below:
Figure 4-39: The "Result Statistics" Screen

For explanations of different parameters and operations corresponding to the "Result
Request Generates statistics concerning a requested Select by clicking on

Date date range with the range set to the current day the calendar icon to the
only by default. Enter the start date in the first right of the box
box and the end date in the second box. The
start date cannot be later than the end date.
Item Name of the test item Selected from a

drop-down box
Sample Sample type of the result statistics. Selected from a

Type drop-down box
Gender Patient gender of the results statistics. Selected from a

drop-down box
104
Age Patients age range and units of the result The patient age range
statistics. is entered directly into
the corresponding box
and age units are
selected from a
drop-down box
Total Tests The total number of tests that have been No operation
completed and produced results under the given
statistical condition
Ave Conc The average concentration of all test results No operation

under the given statistical criteria
SD The average standard deviation of all test No operation

results under the given statistical criteria
Ref Range Statistical item reference range No operation

 Statistics
Allows the user to check data for result statistics according to the statistical criteria
entered.
 Print
Print a result statistics information table.
4.8. Function Settings
In the operating software main interface, click the "Function Setup" button to bring up a
drop-down menu which includes the following 5 options: system Setup, hospital Setup, user
manage, print Setup, and barcode Setup. These options will be introduced in separate
sections to follow.
4.8.1. System Setup

Click the "Function Setup" button to pull up a drop-down menu, click on the "System Setup"
button and enter the system setup screen. This screen is used primarily for function
activation settings and settings concerning the sharing of reagent positions and rules
concerning the removal of reagents.
105
4.8.1.1. Function Enable
Figure 4-40: The "Function Enable" Screen
Explanation of Basic Parameters
 For explanations of different parameters and operations corresponding to

"Sample Request" parameters, see the following table:
Display No. When this option is selected, the Click save after checking
Prefix sample request screen will display
sample numerical prefixes
Suffix sample request screen will display
sample numerical suffixes
Display Barcode When this option is selected, after a Click save after checking
sample's barcode has been scanned
in and the sample is selected on the
sample request screen, the sample's
barcode will be displayed
Display When this option is selected, a box Click save after checking this
Replicates showing the number of repeated option and use the input box
requests will be displayed on the on the right side to set the
sample request screen default number of replicates
Display Dilution When this option is selected, the Click save after checking this
Information sample request screen will display option and use the input box
sample dilution information on the right side to set the
default dilution factor and
sample dilution amount
106
Enable Details Method for showing detailed settings: Click save after checking this
Setup option and select the detailed
1. Select "mouse over" to have the
settings display mode on the
sample application interface display
right side of the screen
detailed settings information when
the mouse cursor is placed over a
standard item;
2. Select "right click" to have the
the user right clicks an item;
 For an basic explanation of "QC Request" parameters, see the following table:
Prefix sample request screen will display
numerical prefixes for QC samples
Suffix sample request screen will display
numerical suffixes for QC samples
Display When this option is selected, a box Click save after checking
Replicates showing the number of repeated
requests will be displayed in the QC
sample request screen
Display Dilution When this option is selected, the QC Click save after checking
Information sample request screen will display
sample dilution information
Enable Details Method for showing detailed settings: Click save after checking
Setup
quality sample application interface
display detailed settings information
when the mouse cursor is placed
over a standard item;
2. Select "right click" to have the
the user right clicks an item;
 For an basic explanation of "Calibration Request" parameters, see the

following table:
107
Display When this option is selected, a box Click save after checking this
Replicates showing the number of repeated option and use the input box
requests will be displayed in the on the right side to set the
calibration request screen default number of replicates
Enable Details Method for showing detailed settings: Click save after checking this
Setup option and select the detailed
settings display mode on the
calibrator application interface
right side of the screen
display detailed settings information
when the mouse cursor is placed
over a standard item;
2. Select "right click" to display
the user right clicks an item; 3 Select
"fixed" to have the calibration request
interface display detailed information
on the selected item on the
right-hand side of the screen
4.8.1.2. Multi-Pos. Rgt Aspirating Rules

When a reagent has been assigned multiple reagent positions, you can use this screen to
set a Sample sequence for multiple reagent positions.
Figure 4-41: The "Multiple Reagent Position and Aspirating Rules" Settings Screen
108
4.8.1.3. Order Setup
Figure 4-42: The "Order Setup" Settings Screen
You can setup test order, print order and display order by click related tabs.
Function Description
For an explanation of the function of the "Order Setup" screen buttons and the
operation thereof, see the following table:
Top Move the selected item directly to the top
Up Move the position order of the selected item up by one
Down Move the position order of the selected item down by one
Bottom Move the selected item directly to the bottom
Save Save the modified order list
Cancel Cancel the modified order list
4.8.2. Hospital Setup

Click the "Function Setup" button to bring up a drop-down menu, click on the "Hospital
Setup" button to enter the Hospital Setup screen which is used to set hospital-related
information.
109
4.8.2.1. Hospital Information
Figure 4-43: The "Hospital Information" Settings Screen
For explanations of different parameters and operations corresponding to the "Hospital

Information" screen, see the following table:
Hospital
Name of the hospital Input directly into the box
Name
Contact
Names of the hospital personnel in charge Input directly into the box
Person
Telephone Hospital phone number Input directly into the box
Address Hospital address Input directly into the box
Home Page Hospital website Input directly into the box
Comment Explanation and description of the hospital Input directly into the box
Shows the department number, department

name, telephone number, whether the Click to add a new
Dept List
department is the examining department department
and additional remarks
Shows the physician's number, name, rank

Doctor List None
and additional remarks
110
Introduction to Application Features
For an explanation of the function of the "Hospital Information" screen buttons and the
Click this button to add an additional input box to the department list.
Add Department
The user can then enter corresponding departmental information
Choose a department and click on this button to delete the selected

Delete
department
Click this button to have the screen display department and physician
Refresh
information saved in the system database
After adding or modifying records in the data list, click this button to
Save
save the changes.
4.8.2.2. Doctor Information
Figure 4-44: The "Doctor Information" Settings Screen

For a basic explanation of the parameters of the "Doctor Information" screen, see the
following table:
Shows the physician's number, name, Click to add a new

Doctor List
position and additional comments physician
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Shows the department number, department

name, telephone number, whether the
Dept List None
department is the examining department and
additional remarks

For an explanation of the meaning of the function buttons found on the "Doctor
Information" screen, see the following table:
Button Function Description
Click this button to add an additional input box to the physician list.
Add Physician
The user can then enter corresponding physician information
Select a physician and click on this button to delete the selected

Delete
physician
Click this button to have the screen display department and physician
Refresh
information saved in the system database
Related Select a physician and select a department from the department list on
Departments the right to associate the physician with the selected department
Save
save the changes.
4.8.3. User Management

Click the "Function Setup" button to bring up a drop-down menu, click on the "User Manage"
button to enter the User Management screen which includes role management and user
management. These are described separately below:
4.8.3.1. Role Management

The "Role Management" interface is used to set appropriate permissions for a given role:
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Figure 4-45: The "Role Management" Settings Screen

For explanations of different parameters and operations corresponding to the "Role
Management" screen, see the following table:

Click to add and enter information
Name Name of set role
into the corresponding box
Detailed description of Click to add and input into the
Description
the set role corresponding box
Disable Disables the current role Check the corresponding box
For an explanation of the function of the "Role Management" screen buttons and the
Button Function
Add Adds a new role
Modify Modifies permissions for the selected role
Delete Deletes the selected role
Cancel Cancels the current operation
Save
save the changes.
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4.8.3.2. User Setup

Used to assign appropriate roles to the user:
Figure 4-46: The "User Setup" Settings Screen
For explanations of different parameters and operations corresponding to the "User

Setup" screen, see the following table:
Username used to log into the Click to add and input into the
Name
software corresponding box
Detailed description of the Click to add and input into the

Description
selected account corresponding box
The password of the selected Click to add and input into the
Password
account corresponding box
Associated Name of the physician using Click to add and input into the
Doctor the selected account corresponding box
Disables use of the selected

Disable Check the corresponding box
account
For an explanation of the function of the "Role Management" Screen buttons and the
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Button Function Explanation
Add Adds a new user
Modify Modify the role assigned to the selected user
Delete Deletes the user currently selected
Cancel Cancels the current operation
Save
save the changes.
4.8.4. Print Setup

Click the "Function Setup" button to bring up a drop down menu, click on the "Print Setup"
button to enter the Print Setup interface which includes Template Setup, Print Order and the
Print List. See below for more details.
4.8.4.1. Template Setup

In the Template Setup menu, the user can set corresponding print formats and templates for
different printing categories based on their specific needs.
Figure 4-47: The "Template Setup" Screen

For a detailed explanation of the various "Report Type" in the "Template Setup" screen,
see the table below:
Report Type Detail
Test Report Individual patient's inspection report, including a summary of patient
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Report Type Detail

information, sample information, test results and diagnostic
information
Chemistry Summarizes test results obtained over a given period by item,

Summary including a summary of the item's information and test results
QC Statistics Print interday quality control curves and quality control data for a
given item
Daily QC Print real time quality control curves and quality control data for a
given item
Rgt Blk Statistics Provides summary information for reagent blanks, including the
blank's absorbance, reactivity and blank limit
Workload Prints statistics for the total testing workload of tester within a given
Statistics period of time, including sample amounts and number of tests
Charge Statistics Prints information regarding test fees for some or all samples within a
given period of time
Cost Statistics Print the statistics concerning the total cost, receipts and profits of all
test items within a given period of time
Test Statistics - Print information concerning the total number of tests and level of
by Chemistry reagent use for all items within a given period of time
Test Statistics - Print the number of samples requested, the corresponding number of
by Sample tests, test information and serum information for a single day
(within 1 Day)
Test Statistics - Print the number of samples requested, the corresponding number of
by Sample tests, test information and serum information for a given period of
(Day-to-day) time (multiple days)
Result Statistics Print out a test results distribution trend chart and trend information
for a given item for a given period of time
ISE Calibration Prints out ISE calibration results for a given period of time
Data
Function Description
For an explanation of the function of the buttons present in the "Template Setup" screen,
see the table below:
Add new Adds new printing templates

template
Edit Template Allows the user to edit template formats that already exist within the
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system
Delete Deletes templates that already exist within the system. Default templates
Template cannot be deleted
Preview View a preview for the selected template
Save Saves the selected information after adjustments to template information

are made
Refresh There is no need to save after editing template information. Use the
refresh option to restore the template to its pre-edited state
4.8.4.2. Print List

Used to display the sample currently printing (automatic printing only) as well as display the
reasons for, and number of, print failures for a given sample.
Figure 4-42: The "Print List" Settings Screen
For an explanation of the function of the "Print List" screen buttons and the operation
thereof, see the following table:
Button Explanation of Functions and Operation
Clears the number of failed attempts for all failed print jobs shown in
Reset all
the print list so that failed jobs can be re-attempted
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Button Explanation of Functions and Operation
Clear Sequence Deletes all failed print jobs currently on the print list
Delete task Deletes the selected failed print job
4.8.5. Barcode Setup

Click the "Function Setup" button to bring up a drop-down menu, click on the "Barcode
Setup" button to enter the barcode setup interface. This interface is mainly used to set up
working modes for the sample and reagent barcode scanning systems, barcode symbology
and encoding rules.
Figure 4-43: The "Barcode Setup" Screen

Sample Barcode
For an explanation of the function and operation of the "Barcode Setup - Sample
Barcode" screen, see the table below:
Parameter Meaning
Sample Barcode Select this option to indicate that sample barcodes can be used within
the operating system. All buttons associated with sample barcode
functions are active. If, on the other hand, this option is not selected,
the corresponding buttons are inactive.
Extract Request This option can only be selected when the link to the LIS host has
Information from been terminated. If this option is selected, when the system scans a
Barcode barcode, sample information will be automatically obtained according
to the associated constituent fields rather than from the LIS system.
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Parameter Meaning
For example: If a sample barcode only includes the serial number and
date of the sample, then when the barcode is analyzed, the number
and date contained in the barcode will be automatically parsed and
added to the sample information.
The appearance of any invalid composition information during the
parsing process will without exception result in the sample
corresponding to the barcode being declared invalid. In particular,
care should be taken with panel serial numbers as the serial number
must conform to the operating software's predefined composition
serial number.
Total The total number of digits in a sample barcode. Can be changed by

the system automatically but may not be modified manually.
The "S" and "E" read-only fields indicate the sample barcode's start
and end positions respectively.
STAT or Not Routine and emergency. Can be set to 0 or 1 bit.
Date Year - Month - Day; this option defaults to 8 bits.
Sample ID Sets the number of digits in a sample serial number.
Sample Type The sample type (serum, etc.) defined in the data dictionary.
Panel No. Panel serial number. If the user is unable to obtain request
information for an LIS host but does not wish to enter request
information manually, information for the requested item can be
included in the barcode; Thus, the group contains a definition of
panels for which a request is possible.
Reagent Barcode
For explanations of the meanings of different parameters and operations corresponding

to the "Barcode Setup - Reagent Barcode" screen, see the following table:
Parameter Meaning
Enable Reagent Select this option to indicate that reagent barcodes can be used
Barcode within the operating system. All buttons associated with reagent
barcode functions are active. If, on the other hand, this option is not
selected, the corresponding buttons will be inactive.
Bar Code Includes Code128, Code39, Codabar, ITF, UPC / EAN and Code93.
Symbology CODE128 is selected by default.
Total The total number of digits in a reagent barcode. Can be changed by

the system automatically but may not be modified manually.
The "S" and "E" read-only fields indicate the reagent barcode's start
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Parameter Meaning
and end positions respectively.
Chemistry No. Serial number of the test item
Rgt Type R1 / R2. This option is 1 bit.
Bottle No. Reagent bottle serial number.
Bottle Type Outer 15ml, inner 30ml. This option is 1 - 3 bits.
Lot No. Reagent production batch.
Expire Date Year - Month or Year - Month - Day; this option defaults to 8 bits.
Bar Code Conversion
Barcode data conversion. The user can convert sample types, combination serial numbers,
item serial numbers, reagent types and bottle sizes to corresponding barcode values.
4.9. System Maintenance
4.9.1. Routine Maintenance

4.9.1.1. Routine Maintenance Commands
Figure 4-44: The "Daily Commands" Screen
Description of Command Functions
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Click send after

Instrument
Self-test retest of the whole machine selecting the command
Self-test Reset
to execute
Click send after

Mixing Bar
Cleaning of the mixer selecting the command
Cleaning
to execute
Mixing Bar Uses wash dilution cleaning solution to Click send after
Enhanced perform an intensive cleaning of the selecting the command
Cleaning mixer to execute
Click send after

Sample Probe
Ordinary cleaning of the sample probe selecting the command
Cleaning
to execute
Sample Probe Uses an wash dilution cleaning solution to Click send after
Enhanced perform an intensive cleaning of the selecting the command
Cleaning sample probe to execute
Wash All Click send after

Reaction Clean All Reaction Cuvettes selecting the command
Cuvettes to execute
Click send after

Performs a water blank test and replaces
Water Blank Test selecting the command
the water blank data currently being used
to execute
Click send after

Needle Block Check water coming out from probe is
selecting the command
Test normal or not
to execute
Click send after

Temperature
Reaction disk heater is turned on selecting the command
Control On
to execute
Click send after

Temperature
Reaction disk heater is turned off selecting the command
Control Off
to execute
Click send after

Liquid Perfusion All the tubes will be filled with liquid selecting the command
to execute
Click send after

Make Fluid Path
All the tubes will be empty selecting the command
Empty
to execute
Click send after

Syringe ready for Syringe pulls down and probe interior pump
selecting the command
removing bubble is turned on
to execute
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Click send after

Close the
Pump is turned off and valve is close selecting the command
pump/valve
to execute
Barcode Scanner Click send after

Barcode scanner beam on and reagent
Beam selecting the command
disk rotate to barcode scanning position
Adjustment to execute
4.9.2. Log Management
Figure 4-45: The "Log Management" Screen

For explanations of different parameters and operations corresponding to the "Log
Management" screen, see the following table:
Date Select the time range of The date range can be selected from the
the log you would like to drop-down box to the left of the "Date" field:
export
daily, three days, five days, ten days and one
month for a total of five options; Alternatively,
you can click on " " to the right of the

"Date" field to select a date range yourself;
Save to Select the directory to Enter the file storage directory in the box to
which you want to the right of the "Export File" text or click on
export the specified log
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contents
the " " icon to selecting a storage path
Pack Allows the user to Click the "Export" button to execute the export
export a file to the operation
export directory in the
form of a zip file
Select Select the files you Select a given file for export by placing a "☑"
would like to export by in the box on the same line as the name of
inserting a "☑" in the the file you would like to export
appropriate boxes in the
lower part of the screen
Folder name Name of the folder /

corresponding to files
designated for export
Content Type Refers to the type of /

data contained in files
designated for export,
including raw data,
configuration files,
and logs
Folder Path The path of the directory /

in which exported files
are stored
Size The size of the data /

contained in files
designated for export
4.9.3. Temperature Curve

Click the "Temperature Curve" button to enter the Temperature Status screen where you can
check and monitor the temperature of the reaction disk.
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Figure 4-46: The "Temperature Curve" Screen

For explanations of different parameters and operations corresponding to the "Temperature
Curve" screen, see the following table:
No. Indicates the serial number of /

monitoring data
Time The time at which monitoring /

data was created
Temperature Indicates the temperature of /

monitoring data
Temperature A trend chart showing /

Trends Chart temperature monitoring data
Interval Time / Select the interval mode for The default interval is 30s
Monitoring Cycle monitoring data between temperature
Test measurements; The user can opt
Temperature to have temperature monitoring
Data performed according to cyclical
testing, by placing a "☑" in the
box next to "Monitoring Cycle Test
Temperature Data."
Start Start monitoring of Click "Start Monitoring" and the

temperature data software will monitor the reaction
disk temperature according
to the selected data monitoring
interval method
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4.9.4. AD Curve
Click to enter the lamp AD value monitoring screen.
Input collection interval time and cuvette number, click ―Start‖ button, the system will rotate
reaction disk and that cuvette will stop at light detecting position. The upper area will display
the real time AD values of each channel of this cuvette. Click ―Stop‖ button to stop
monitoring.
To clear the display values, click ―Clear Data‖ button.
To adjust the lamp AD value, you need take out one cuvette and rotate to the position, click
―AD Adjust‖ button to start photometer adjustment tool.
Figure 4-47: The "AD Curve" Screen
No Wavelength sequence /
Collection Time gap between collecting

/
intervals optical data
Collection Time gap between collecting

Input directly
intervals optical data
Cuvette position that rotates to the

Cuvette No. Input directly
light path
4.9.5. Probe Parameter Configuration

Click to enter the Probes Parameters screen which includes: Sample Probe Parameters,
125
Mixing Bar Parameters, Reaction disk Optical System Parameter and Peristaltic Pump/
Sample probe wash pump/ Mixing bar wash pump/ Cuvette wash pump Parameter. Users
can adjust and set sample probe, mixer and reaction disk optical and electrical parameters
as well as pump operating parameters to ensure normal operation of the instrument.
4.9.5.1. Sample Probe Parameter Configuration

See section 4.9.5.8 for a detailed description of the various parameters and function buttons
in this menu.
Figure 4-48: The "Sample Probes Parameters" Screen
4.9.5.2. Mixing Bar Parameter Configuration

in this menu.
126
Figure 4-55: The "Mixing Bar Parameters" Screen
4.9.5.3. Reaction Disk Optical System Parameters Configuration

in this menu.
Figure 4-56: The "Reaction disk Optical System Parameter" Screen
4.9.5.4. Peristaltic Pump Parameters Configuration

For analyzer with auto wash function only. See section 4.9.5.8 for a detailed description of
the various parameters and function buttons in this menu.
127
Figure 4-57: The "Peristaltic Pump Parameter" Screen
4.9.5.5. Sample Probe Wash Pump Parameters Configuration

in this menu.
Figure 4-58: The "Sample Probe Wash Pump Parameter" Screen
4.9.5.6. Mixer Bar Wash Pump Parameters Configuration

in this menu.
128
Figure 4-59: The "Mixing Bar Wash Pump Parameter" Screen
4.9.5.7. Cuvette Wash Pump Parameters Configuration

For analyzer with auto wash function only. See section 4.9.5.8 for a detailed description of
the various parameters and function buttons in this menu.
Figure 4-60: The "Cuvette Wash Pump Parameter" Screen
4.9.5.8. Introduction to Parameters and Features

129
Detailed description of parameter

Description /
settings names
Range Adjustable parameter range /
The software's default

Default /
configuration parameter value
The set parameter value. The

Enter a modified value into the set
value must be within the
Default value box corresponding to the
adjustable range for the
selected "Description"
parameter
Comment Input directly
Alignment List of commands for debugging

/
Commands the instrument
Names of parameters required for

Para. Name /
debug commands
Specific values corresponding to

Can be input directly into the
Value parameters required for debug
blank space below
commands
Button Function
Effectuate Send modified configuration parameters to a slave machine. The

Configuration configuration parameters will be used in subsequent operations by
the instrument
Save configuration Stores modified configuration parameters on the computer
Execute Select the desired command from the available debug commands,
Command click "Execute Command" and the instrument will carry out the
corresponding action
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Simplified Operating Procedures
5. Simplified Operating Procedures
5.1. Operational Procedures for Basic Functions
5.1.1. Add Item
1) Left click the Parameter button on the Main Screen;
2) Choose Routine Chemistry to enter the item parameter editing screen;
3) Click the "Add" button, and enter the desired parameters for each item in the Basic
Parameters, Monitoring Parameters and QC Parameters interfaces according to
the significance of each item and applicable reagent manuals;
4) Click the "Save" button to save the new item's parameters.
5.1.2. Change Item Parameters
3) Select the item you wish to modify in the item list on the left hand side of the screen;
4) Click the "Modify" button to edit the parameters of items you wish to modify,
according to the significance of each item and applicable reagent manuals;
5) After editing, click the "Save" button.
Notes:
1) A recalibration analysis needs to be performed after modifying the
following parameters; failure to do so may prevent you from obtaining
accurate results: measurement method, reaction direction, main
wavelength, sub-wavelength, sample volume, R1, R2, blank time and
reaction time.
2) Do not modify an item's parameters during the testing process. Failure to
adhere to this rule may prevent you from obtaining accurate results:
131
5.1.3. Delete Item
3) Select the item you wish to delete from the item list on the left hand side of the screen;
4) Click the "Delete" button;
5) In the dialog box that appears, select the "Yes" button to confirm the deletion, or
click the "No" button to cancel.
Notes:
1) Once an item is deleted, all the information contained in the item will be
deleted, including test results and other information.
2) The deletion of item parameters is prohibited during the testing process.
5.1.4. Add Control Solution
2) Select QC Setup to enter the quality control solution editing screen;
3) Click the "Add" button to add a new row to the left screen, left click a blank input box
to activate input of the control solution name, batch number and expiration date
information and then enter the corresponding information;
4) Enter target value and standard deviation information for each item in the right
screen;
5) Click the "Save" button to save information pertaining to the newly-added control
solution.
5.1.5. Modify Control Solution
3) Select the quality control solution you wish to modify from the control solution display
area on the left hand side of the screen;
4) Click the "Modify" button to edit the information you wish to modify;
132
5) Click the "Save" button to save the modified information.
5.1.6. Delete Quality Control Solution
3) Select the quality control solution you wish to delete from the control solution display
area on the left-hand side of the screen;
5.1.7. Add New Calibrator
2) Select Calibrator Setup to enter the Calibrator editing screen;
3) Click the "Add" button and, at the top of the screen, left click a blank input box to
activate input of the calibrator name and sample position and then enter the
corresponding information;
4) Enter the corresponding concentrations and activity values for the current calibrator
for each item in the Concentration Input field;
5) Click the "Save" button to save information pertaining to the newly-added calibrator.
5.1.8. Modify a Calibrator
3) Select the calibrator solution you wish to modify from the calibrator solution display
4) Click the "Modify" button to edit the information you wish to modify;
5.1.9. Delete a Calibrator
133
3) Select the calibrator solution you wish to delete from the calibrator solution display
5.1.10. Set Reagent Positions
1) Left click on the Online Status button on the Main Screen;
2) Select the Reagent disk interface;
3) Select an empty reagent position, move the mouse over the item in the "Chemistry
List" for which you want to set the position, and select either R1 or R2;
4) Input reagent information in the "Reagent Information" display area in the lower
right of the screen, including the reagent name, size, expiration date, batch number
and other information;
5) Click the "Save" button to save the edited information.
5.1.11. Modify Reagent Information
3) click on the reagent position you wish to modify on the reagent disk on the right of
the screen;
4) Modify the reagent information in the "Reagent Information" display area in the
right of the screen, including the reagent name, size, expiration date, batch number
and other information;
5.1.12. Release Reagent Positions
134
3) Click on the reagent position you wish to release on the reagent disk on the right of
the screen;
4) Click the "Release Position" button;
5) Click the "Yes" button on the screen that pops up to confirm release of the position or
click "No" to cancel the release of the position.
Notes:
To release all locations, simply click the "Release All" button.
5.1.13. Reagent Blank Test Procedure

5.1.13.1. Request
1) Left click the Test Request button on the Main Screen;
2) Click " Reagent Blank Request " to enter the Reagent Blank Request interface;
3) Select an item for which you want to perform a reagent blank test;
4) Click the "Request" button to complete the request process.
5.1.13.2. Testing
1) Place a reagent blank sample (typically deionized water or saline) in Sample
Position 40;
2) Click on the Start button in the shortcut button area on the right side of the main
interface;
3) Select the sample disk and reagent disk where the current test will be performed;
4) Click "OK" to start the test.
5.1.14. Calibration Test Procedure

5.1.14.1. Request
2) Click " Calibration Request " to enter the Calibration Request screen;
3) Select the item for which the calibration test needs to be performed as well as the
number of repetitions and the corresponding calibrator;
5.1.14.2. Testing
1) Place all calibrators in their corresponding sample positions;
135
2) Click on the start button in the shortcut button area on the right side of the main
interface;
Notes:
When performing a calibration for a new chemistry, make sure a reagent
blank is tested.
5.1.15. Quality Control Test Procedure

5.1.15.1. Request
2) Click " QC Request " to enter the QC Request screen;
3) Select a sample disk and sample position;
4) Enter the quality control sample number and select a quality control solution;
5) Select a quality control test item;
5.1.15.2. Testing
1) Place all quality control solutions in their corresponding sample positions;
2) Click on the Start button in the shortcut button area on the right side of the main
interface;
5.1.16. Sample Testing Procedure

5.1.16.1. Request
2) Click " Sample Request " to enter the Sample Request screen;
3) Choose whether or not the sample is an emergency room sample and select a
sample disk and sample position;
4) Enter the sample serial number and other information;
136
5) Select a test item;
5.1.16.2. Testing
1) Place all test samples in their corresponding sample positions;
2) Click on the start button in the shortcut button area on the right side of the main
interface;
4) Select the range of samples to be tested. If you only want to test some of the
samples, enter a corresponding sample range;
5.2. Operating Procedures for Opening a New Item
1) Add new in item parameters;
2) Set the item's reagent position;
3) Add calibrators for the current item or add a concentration for the current project in
addition to an existing calibrator;
4) Add quality control solutions for the current item or add a target value and standard
deviation for the current project in addition to an existing quality control solution;
5) Submit a Calibration Request for the current item (select a reagent blank);
6) Start the calibration test;
7) After calibration is successful, perform a quality control request and start the
quality control test;
8) Once the integrity of the quality control has been confirmed, a standard sample test
can be carried out.
Notes:
When performing a calibration for a new item, make sure to test a

reagent blank.
137
5.3. Routine Operational Procedures
5.3.1. Pre-Startup Check

1) Check that sufficient printer paper is available and, if not, add printer paper;
2) Check that there are no issues with the power supply and that the connection
is stable;
3) Check that the connection of the communications cables between the printer and
the computer as well as the connection between the computer and the analysis
unit are stable;
4) Place a tube with deionized or distilled water or saline in Sample Position 40 on the
sample disk;
5) Place a sufficient amount of ISE wash solution, deionized water or other wash
solution in Reagent Position 39 (Please ignore this if no ISE module);
6) Check that purified water is available and, if not, supplement immediately; If a

water supply machine is being used, please make sure the water supply machine
is switched on and running;
7) Check that enough wash solution is present and supplement if necessary;
8) Check that the system probes, mixer are free of bending, dirt and excess water;
9) Check that there are no bubbles or leaks in the instrument's syringe;
10) Open the reagent bottle caps;
11) Check that the reaction disk cover, reagent disk cover and sample disk cover are
closed.
Notes: Biological Contamination

1) All waste should be considered a source of contagion and gloves
should be worn during handling;
2) All parts of the apparatus are subject to potential biological

contamination, and protective gloves should be worn during
operation.
5.3.2. Powering On the System

Turn on each power supply in the following order:
1) Flip the main power switch on the left-hand side of the back of the analysis unit to
the ON position;
138
2) Press the power switch on the right-hand side of the analysis unit (an indicator light
should come on after pressing the switch);
3) Power on the monitor;
4) Turn on the computer;
5) Turn on the printer.
5.3.3. Order of Operational Procedures

Double-click the software shortcut icon on the desktop to log into the system and start up the
system using the following operational procedures. After approximately 2 minutes the
system will show the Main Screen for operating the software:
1) Reset all operating parts;
2) Open the thermostat and heat up the reaction disk;
3) Turn on the system lamp;
4) Prime the system fluid lines;
5) Check the lamp status;
6) Wash all cuvettes and do water blank test. (For analyzer with auto wash function: If
these 2 options are selected, it takes 15 minutes more)
Notes: Alarms and Dirty Cuvettes
1) If an alarm is issued during system startup, click the alarm to view

detailed information and solutions;
2) The system will automatically monitor the status of the system lamp
during startup and if the system indicates that the luminous intensity
of the lamp is insufficient, investigate the reason immediately and
replace the lamp if necessary.
5.3.4. System Setup

1) Set hospital, department and physician-related information;
2) Set a username, preliminary password and operating privileges;
3) Set patient-related information and select or edit the print format for different reports.
5.3.5. Item Parameter Settings

Enter analysis parameters for each item based on the significance of each parameter as
well as the instructions included with your reagent kit.
139
Notes: Analysis Parameters

Incorrect analysis parameters can lead to erroneous measurement results.
Please consult Manufacturer or your reagent supplier for more information.
5.3.6. Reagent Position Settings

Set the position of each item in the reagent disk.
Notes:
For two-reagent items, R1 and R2 must be set to the same reagent disk;
5.3.7. Calibrator Setup

1) Add New Calibrator;
2) Set the position of the calibrator on the sample disk;
3) Set the concentration for each item corresponding to a given calibrator.
5.3.8. QC Settings
1) Add Control Solution
2) Set the target value and standard deviation for each item corresponding to a given
control solution;
3) Set quality control rules for each item.
5.3.9. Test Request

1) Reagent blank request;
2) Calibration request;
3) QC request;
4) Sample test request.
5.3.10. Test Preparation

1) Place reagents on the reagent disk according to the set reagent positions and
supplement immediately if reagent levels are low;
2) Place the calibrator on the sample disk according to the set calibrator position;
3) Place the quality control solution on the sample disk according to the requested
quality control solution position;
4) Place the test sample on the sample disk according to the requested sample
position;
5) Check the clean cuvette is enough or not, if not, place new cuvettes into reaction
disk and click ―Replace Cuvette‖ button(For analyzer without auto wash function).
140
Notes:
1) Carefully check the reagents and samples to ensure that no
insoluble compounds, such as cellulose or fibrin, are suspended in
solution. Failure to do so may result in obstruction of the reagent or
sample probes.
2) If the sample contains suspended insoluble matter, the supernatant

should be aspirated off and transferred to a clean sample tube.
5.3.11. Start
1) Click the "Start" shortcut;
2) Select the reagent disk and sample disk with which you want to start the test (No. 1
by default);
3) Enter the sample range for the test you wish to start;
4) Click the "Confirm" button.
Notes:
You can also start a reagent blank test, calibration test, quality control
test or standard test at the same time, in accordance with the following
priority levels.
1) Reagent Blank Test;
2) Calibration Test;
3) Quality Control Test;
4) Standard Test.
Note:
1) An unstable reaction disk or light source may adversely impact
the test results. Do not perform any tests until the reaction disk or
light source are stable;
2) Always ensure that the reaction disk cover is closed during the
testing process. Failure to do so may result in poor
thermoregulation of the reaction disk, abnormal noises and
damage to the apparatus probes.
3) Always ensure that the reagent disk cover is closed during the
testing process. Failure to do so may result in poor refrigeration of
the reagent disk, abnormal noises and damage to the apparatus
probes.
5.3.12. Test Result Query

5.3.12.1. Calibration Result Query
1) Left click the Results button on the Main Screen;
2) Click "Calibration" to enter the calibration results query page;
3) Select an item and calibration time period to perform a query;
141
4) Click "Calibration Curve" after selecting a particular calibration record to enter the
detailed calibration screen corresponding to the calibration record.
5.3.12.2. Quality Control Result Query
2) Click "QC" to enter the quality control results query page;
3) Select the quality control query type, project, time, and quality control solution
conditions to perform a query;
4) On the right side page you can view the quality control status, quality control results
and quality control graphics for a given item.
5.3.12.3. Sample Results Query
2) Click "Sample" to enter the sample results query page;
3) Click the "Query Conditions" button to select search criteria for performing
your query.
5.3.12.4. Reagent Blank Query Results

2) Click "Reagent Blank" to enter the reagent blank query results page;
3) Select an item and start and end time period to view your results;
4) Reagent blank reactivity and a trend graph for a given item can be viewed on the
reagent blank page on the right side of the screen.
5.3.13. Adding Tests

1) Add standard sample tests;
2) Add emergency sample tests;
3) Add quality control tests;
Notes:
1) During a test, an unlimited number of samples and quality control
tests can be added;
2) During the test process, do not add calibration tests for items for
which calibration parameters are already available and for which
testing is currently in progress, as this may result in some samples
142
being calculated according to previously set calibration

parameters while other samples are calculated according to newly
set calibration parameters.
5.3.14. Shutdown
Click on the "Shutdown" shortcut button on the right side of the main screen and select
routine shutdown in the menu that pops up to perform a shutdown. For analyzer without
wash mechanism, it will reset all units and then exit software. For analyzer with auto wash
mechanism, it will do in the following order:
1) Dry all cuvettes;
2) Fill up the cuvettes with purified water;
3) Exit the operating software.
Notes:
1) If a test stops abnormally, then all cuvettes must be washed once
before draining (will require approximately 16 minutes).
2) For analyzer with auto wash function, if you choose the long
holiday shutdown option, then system will dry all the cuvettes and
then exit the software.
3) If you need to turn off the computer, simply select Shutdown
Computer and the computer will shut down automatically after you
close the software.
5.3.15. Powering Off the System

Turn off each power supply in the following order:
1) Analysis unit power supply;
2) Computer power supply;
3) Monitor power supply;
4) Printer power supply.
Notes:
1) The main power supply is located on the back of the analysis unit.
If reagents need to be refrigerated, then do not turn off the main
power supply; you need only turn off the analysis unit;
2) If you need to turn off the main power supply, switch the main
power switch from ON to OFF.
5.3.16. Post-Shutdown Inspection

1) Remove all samples, calibrators and quality control solutions from the sample disk;
2) Cap all reagent bottles; If the analyzer main power is off, reagents in the reagent
disk should be stored in a refrigerator;
143
3) Wipe down the analyzer countertop;
4) Wipe off any contaminants or water droplets present on the apparatus probe, mixer,
or cleaning mechanism nozzles.
144
6. Analysis Principles and Computational Methods
6. Analysis Principles and

Computational Methods
6.1. Analysis Principle
The instrument operates by establishing a formal relationship between absorbance and

concentration or activity using the law of absorbance for solutions exposed to a light source
(the Beer–Lambert law), or the law governing the opacity of suspensions to a light source;
The biochemical analyzer's optical system can be used to monitor the absorbance of a
specific item throughout the reaction process and, based on changes to absorbance
following the reaction or the rate of change of absorbance throughout the reaction process,
in conjunction with corresponding calibration parameters and computational factors, the
software is able to compute the concentration and activity of the substance examined.
6.2. Analysis Procedure
The procedure will be described in terms of the machine's actions, the position where each
action occurs, the testing process and the system's optical metering point.
6.2.1. Actions Performed by the Device
For analyzer with auto wash function, the system performs the following actions in a test
cycle to complete all assigned tests:
1) A cuvette is placed below the first washing and automatic cleaning is performed. The
reaction disk turns by 51 cuvette positions (absorbance measurements are carried out
during the rotation) and the system pauses; The disk rotates to the cuvette position currently
being used for R1 and the system pauses; The disk rotates by 51 cuvette positions and the
system pauses. This is referred to as a single cycle;
2) From the 1st to the 40th cycle, addition of the first reagent, sample and second reagent
as well as reaction monitoring are carried out and absorbance is measured once during
each cycle; With each cycle, the position of the reaction cuvette is moved forward by one
position;
145
For analyzer without auto wash function, the system performs the following actions in a test
cycle to complete all assigned tests:
1) The reaction disk turns by 51 cuvette positions (absorbance measurements are carried
out during the rotation) and the system pauses; The disk rotates to the cuvette position
currently being used for R1 and the system pauses; The disk rotates by 51 cuvette positions
and the system pauses. This is referred to as a single cycle;
2) From the 1st to the 40th cycle, addition of the first reagent, sample and second reagent
as well as reaction monitoring are carried out and absorbance is measured once during
each cycle; With each cycle, the position of the reaction cuvette is moved forward by one
position;
6.2.2. Operating Position
6.2.3. Testing Process

This system feature fixed testing procedures with each reaction including a total of 40 test
cycles. In high speed mode, each cycle lasts 24 seconds while in standard mode each cycle
lasts 36 seconds.
6.2.4. Optical Metering Point

For a given reaction, a single optical measurement is taken once every cycle for a total of 40
optical metering points. In high speed mode, the time interval between two adjacent optical
metering points is 24 seconds; In standard mode, the time interval between two adjacent
146
optical metering points is 36 seconds, as shown in the Figure below:
147
6.3. Analysis Methods and Reactivity Calculations
6.3.1. Absorbance Calculation

The formula used to calculate absorbance (A) by the analyzer is as follows:
Where:
1) "Log" refers to a common logarithm of base 10;
2) "AD" indicates the value of the intensity of the transmitted light following
photoelectric conversion and digital to analog conversion;
3) " " refers to the AD value when the system lamp is not on, " " refers to
the AD value of Purified water in the cuvette and " " indicates the AD value
of the test solution in the cuvette;
4) The absorbance data shown in reaction curves generated by the system is amplified
by a factor of 20,000.
Description:
Reaction classification is performed based on the characteristics of a particular reaction's

speed during the reaction process. The analyzer divides all reactions into three categories:
end-point method, two-point method (fixed time method) and kinetic method. These are
described in detail separately below:
 Test Methods, Test methods include the end-point method, two-point method (fixed time
method) and kinetic method.
 Reaction time [N] [P]: The period of time from when a reaction is started to the time
when monitoring of the reaction ends.
1) For single reagent items, the reaction time refers to the time which elapses after the
addition of the sample S;
2) For double reagent items, the reaction time refers to the time which elapses after the
addition of R2;
3) This section includes two input boxes into which the reaction monitoring start time
and reaction monitoring end time are entered. These quantities are represented by
N and P.
 Blank Time [L] [M]: The time before a reaction for a given test is started.
148
1) For single reagent items, blank time refers to the time interval from the time R1 is
added to the time the sample S is added;
2) For double reagent items, blank time refers to the time interval from the time the
sample S is added to the time R2 is added;
3) This section also includes two input boxes into which the blank monitoring start
time and blank monitoring end time are entered. These quantities are represented
by L and M.
 For dual-wavelength items, absorbance A is the difference in absorbance at the main

and sub-wavelengths; For single wavelength items, A is the absorbance at the primary
wavelength.
6.3.2. Endpoint Method

The endpoint method, also known as the "equilibrium method" is a method in which, once
the reaction in question has reached an equilibrium and there are no longer any changes to
be observed absorbance values after a certain period of time and the increase (or decrease)
in absorbance precipitated by the reaction is proportional to the concentration of the
substance being measured.
6.3.2.1. Single Reagent Endpoint Method
S
R1
Optical
L M N P Metering Point
Figure 0-1 Single Reagent Endpoint Methods A and B Reaction Curves
Endpoint Method A
Reaction time [N] [P], 10 ≤ N ≤ P ≤ 40, where P ≤ N +4;
Blank time [L] [M], 1 ≤ L ≤ M ≤ 9, where M ≤ L +4; L and M default to 7-9.
The formula by which reactivity (R) is calculated is as follows:
R  Ai  kAb
149
Where:
VR1
1) k is a single reagent volume correction factor and VR1 and VS
VR1  VS
represent the volumes of the first reagent and sample.
2) The second term in the equation, kAb , represents the reagent blank correction
value. Real-time deduction of the reagent blank is possible while deduction of the
sample blank is not possible. If you need to perform a sample blank correction, you
must request separately a sample blank test and the formula for computing the
sample blank reactivity, RSb , is the same as the above formula used to calculate R -
that is, Rsb  Ai  kAb . Reactivity following sample blank correction is computed as
R '  R  RSb .
3) Ai indicates absorbance at the reaction endpoint, calculated as follows:
a) If N = P, then the corresponding input is [P] [P] and only one point is used. That
is: Ai  AP  AN .
b) If P = N +1, then the corresponding input is [N] [N+1] and two points are used.
AN  A N  1
That is: Ai  .
2
c) If P = N +2, then the corresponding input is [N] [N+2] and three points are used.
Thus, Ai is the average of the two absorbance data points remaining after the
largest outlier is removed.
d) If P = N +3, then the corresponding input is [N] [N+3] and four points are used.
Thus, Ai is the average of the two absorbance data points remaining after the
largest and smallest outliers are removed.
e) If P = N +4, then the corresponding input is [N] [N+4] and five points are used.
Thus, Ai is the average of the three absorbance data points remaining after
the largest and smallest outliers are removed.
4) Ab refers to the absorbance during blanking and this value is calculated using the
same method as that used for absorbance Ai .
Endpoint Method B
Endpoint Method B is also sometimes called the non-volume-corrected two-point blank

endpoint method and the method is primarily intended to eliminate the effects of R1 blank
absorbance or S blank absorbance on concentration for certain clinical samples. The only
difference between this method and Endpoint Method A is that in this method there is no
need to multiply by a volume correction factor when calculating reactivity. All other
requirements are identical to Endpoint Method A.
Reaction time [N] [P], 10 ≤ N ≤ P ≤ 40, where P ≤ N+4;
Blank time [L] [M], 1 ≤ L ≤ M ≤ 9, where M ≤ L +4; L and M default to 7-9.
The formula by which reactivity (R) is calculated is as follows:
150
R  Ai  Ab
In the above formula, the calculation of Ai and Ab are exactly the same as with
Endpoint Method A.
Endpoint Method C
Endpoint Method C is also sometimes called the "post-reaction two-point endpoint method"
and does not include a blank time setting. It is primarily intended to eliminate the effects of S
or R2 blank absorbance on concentration for certain clinical samples. It differs from
Endpoint Method A in that:
1) There is no need to multiply by a volume correction factor when calculating reactivity;
2) At the same time, there is no need to set a blank time. Only a reaction time needs to
be set;
3) The requirements of the two methods in terms of start and end points of the reaction
time interval are different;
All other requirements are fully consistent with Endpoint Method A.
S
R1
Optical
N P Metering Point
Figure 0-2 Single Reagent Endpoint Method C Reaction Curves
Reaction time [N] [P], 10 ≤ N ≤ 12 < P ≤ 40;
Blank time [L] [M], empty by default, input is prohibited.
Reactivity Calculation:
R  AP  AN
AP represents the absorbance of the Pth cycle and AN represents the absorbance value
of the Nth cycle. There is no need to perform a sample blank correction.
151
6.3.2.2. Double Reagent Endpoint Method
R2
R1 S
Optical
L M N P Metering Point
Figure 0-3 Double Reagent Endpoint Methods A and B Reaction Curves
Endpoint Method A
Blank time [L] [M], 10 ≤ L ≤ M ≤ 18, where M ≤ L +4; L defaults to 16 while M defaults
to 18.
The calculation of reactivity (R) is performed as follows:
R  Ai  k ' Ab
Where:
VR1  VS
1) k'  is a double reagent volume correction factor and VR1 , VS
VR1  VS  VR 2
and VR 2 represent the volumes of the first reagent, sample and second reagent.
2) The second term in the equation, k ' Ab , indicates the mixed blank correction value
for reagent R1 and sample S. The mixed blank of the first reagent R1 and the
sample S, can be deducted in real time but the R2 (second reagent) blank cannot be
deducted. If you need to perform a correction for R2, you must request separately a
reagent blank test and the formula for computing the R2 blank reactivity, RR 2 , is the
same as the above formula used to calculate R - that is, reactivity following sample
blank correction is calculated as R  R  RR 2 .
'
3) Calculation of Ai : Equivalent to the method for calculating Ai using the single

reagent endpoint method as described in 6.3.2.1.
4) Calculation of Ab : Equivalent to the method for calculating Ai using the single

reagent endpoint method as described in 6.3.2.1.
152
Endpoint Method B
Blank time [L] [M], 10 ≤ L ≤ M ≤ 18, where M ≤ L +4; L defaults to 16 while M defaults
to 18.
R  Ai  Ab
The second term in the equation for R above, Ab indicates the mixed blank correction
value for the sample and the first reagent without a volume correction. The mixed blank
of the first reagent and the sample, can be deducted in real time but the R2 (second
reagent) blank cannot be deducted. If you need to perform a correction for R2, you must
request separately a reagent blank test and the formula for computing the R2 blank
reactivity, RR 2 , is the same as the above formula used to calculate R - that is,
RR 2  Ai  Ab . Thus reactivity following sample blank correction is calculated as
R '  R  RR 2 .
Endpoint Method C
R2
R1 S
Optical
N P Metering Point
Figure 0-4 Double Reagent Endpoint Method C Reaction Curve
Reaction time [N] [P], 19 ≤ N ≤ 21 < P ≤ 40;
Blank time [L] [M], empty by default, input is prohibited.
R  AP  AN
AP represents the absorbance of the Pth cycle and AN represents the absorbance value
of the Nth cycle. There is no need to perform a sample blank correction.
153
6.3.3. Two-Point Method (Fixed-Time Method)

The Two-Point Method, also known as the first-order kinetic method, two-point rate method
and fixed-time method, refers to a first order correlation between reaction rate and substrate
concentration over a defined period of time, expressed formally as v = k[S]. Since the
substrate is constantly being consumed during the reaction, the overall reaction speed is
constantly decreasing and this is manifested as a reduction in the rate of increase (or
decrease) in absorbance. Within the specified reaction time, the reaction solution
absorbance increase (or decrease) (△ A / min) is proportional to the concentration and the
measured substance.
Two-point methods are divided into single interval and double interval two-point methods
depending on whether or not deduction of a sample blank is necessary. For double interval
two-point methods, real time deduction of the sample blank is possible. That is, the rate of
change in absorbance between the two points within the sample blank period is taken as the
sample blank deduction.
Two-point method allows the user to check for substrate depletion and in the event that
substrate depletion has occurred, corresponding markings will be provided in the results.
6.3.3.1. Single Reagent Two-Point Method
Figure 0-5: The Single Reagent Two-Point Method Reaction Curve
Reaction time [N] [P], 10 ≤ N < P ≤ 40;
Blank time [L] [M], 1 ≤ L ≤ M ≤ 9, where L and M are empty by default; a blank correction
is not performed.
AP  AN
R ( R must be converted to a per-minute reaction rate)
tP  tN
Where:
1) Ap and AN represent the absorbance values during the Pth cycle and
Nth cycle respectively;
154
2) t p and t N represent the cycle times of the Pth cycle and Nth cycle
respectively;
AM  AL
3) Blank Reactivity Rb : Rb  ( Rb must be converted to Rb in
tM  tL
per-minute units)
AM and AL represent the absorbance values during the Mth cycle and Lth
cycle respectively;
t M and t L represent the cycle times of the Mth cycle and Lth cycle
respectively;
Note:
If a blank time has been set, a blank correction must be performed and the
blank-corrected reactivity is calculated as R = R - K  Rb where K is the
'
VR1
single reagent volume correction factor, K  .
VR1  VS
6.3.3.2. Double Reagent Two-Point Method
Figure 0-6: The double Reagent Two-Point Method Reaction Curve
Reaction time [N] [P], 19 ≤ N < P ≤ 40;
Blank time [L] [M], 10 ≤ L < M ≤ 18, where L and M are empty by default; a blank
correction is not performed.
1) Response R: computation is identical to the single reagent method discussed

in 6.3.3.1.
2) Blank Reactivity Rb : calculation is identical to the single reagent method

discussed in 6.3.3.1.
blank-corrected reactivity is calculated as R = R - K  Rb where K is the double
' ' '
155
VR1  VS
reagent volume correction factor, K '  .Using the blank time settings, the
VR1  VS  VR 2
instrument can only automatically deduct the first reagent and sample mixed blank and
cannot deduct the second reagent blank. If you need to deduct the second reagent blank,
you will need to separately request a reagent blank test. The reactivity of the second
reagent blank RR 2 is calculated in the same way as reactivity R above. The second
''
reagent blank corrected reactivity is expressed as R = R - RR 2 .
6.3.4. Kinetic Method

Also known as the zero-order rate method, rate method, or continuous monitoring method,
the Kinetic Method implies a zero-order correlation between the reaction rate and substrate
concentration; that is, there is no relationship to substrate concentration. Thus, during the
entire reaction process, the reactant can uniformly (at constant speed) generate a product,
causing the absorbance of the testing solution to uniformly decrease or increase under a
given wavelength. The rate of decrease or increase (△A/min) and the testing substance’s
(catalytic substance) activity or concentration are directly correlated. This method is mainly
used for enzyme activity measurement.
In practice, because the substrate concentration cannot be infinitely large, as the reaction
proceeds, after the substrate has been consumed to a certain degree, the reaction will no
longer be zero order. Thus, the zero-order rate law is applicable for specific time periods and
one must choose zero-order reaction time periods over which to conduct monitoring in order
to ensure the accuracy of the test results.
Kinetic methods are divided into single interval and double interval kinetic methods
depending on whether or not deduction of a sample blank is necessary. For double interval
kinetic methods, real time deduction of the sample blank is possible. That is, the rate of
change in absorbance between the two points within the sample blank period is taken as the
sample blank deduction.
The kinetic method allows the user to check for substrate depletion and, in the event that
substrate depletion has occurred, corresponding markings will be provided in the results.
The kinetic method allows the user to check for linear limits and if the linear limit has been
exceeded, corresponding markings will be provided in the results.
6.3.4.1. Single Reagent Kinetic Method

R1 S
L M N P Optical
Metering Point
Figure 0-7: Single Reagent Kinetic Method Reaction Curve
156
Reaction time [N] [P], 10 ≤ N ≤ P ≤ 40 and P ≥N+2, so at least 3 optical metering points
are needed;
Blank time [L] [M], 1 ≤ L ≤ M ≤ 9, where M ≥ L +2, so at least 3 optical metering points are
needed; L and M are blank by default, and no blank correction is performed.
1) Reactivity R : R = ANP ,  represents using a least square calculation to

obtain the rate of change in absorbance per minute between the optical
metering points (N, P).
Least Square Formula:

P
 (t i  t )  ( Ai  A)
R iN
P
 (t
i N
i  t)2
Where N is the start point of the zero-order kinetics reaction interval, P is the end point of
the zero order kinetics reaction interval, Ai is point i’s absorbance, A is the average
absorbance between N and P, ti is time at point i, and t is the average time from N to P.
2) Blank Reactivity Rb : The calculation is the same as that described for R above,
R= ALM
blank-corrected reactivity is calculated as R = R - K  Rb where K is the single reagent
'
VR1
volume correction factor, K  .
VR1  VS
6.3.4.2. Double Reagent Kinetic Method
A
S R2
R1
Optical
L M N P
Metering Point
Figure 0-8: The Double Reagent Rate Method Reaction Curve
Reaction time [N] [P], 19 ≤ N ≤ P ≤ 40 and P ≥N+2, so at least 3 optical metering points
are needed;
157
Blank time [L] [M], 10 ≤ L ≤ M ≤ 18, where M ≥ L +2, so at least 3 optical metering points
are needed; L and M are blank by default, and no blank correction is performed.
1) Reactivity R : The calculation is identical to the single reagent kinetic method

discussed in 6.3.4.1.
2) Blank Reactivity Rb : The calculation is identical to the single reagent kinetic
method discussed in 6.3.4.1.
blank-corrected reactivity is calculated as R = R - K  Rb where K is the double
' ' '
VR1  VS
reagent volume correction factor, K '  .Using the blank time settings, the
VR1  VS  VR 2
instrument can only automatically deduct the first reagent and sample mixed blank and
cannot deduct the second reagent blank. If you need to deduct the second reagent blank,
you will need to separately request a reagent blank test. The reactivity of the second
reagent blank RR 2 is calculated in the same way as reactivity R above. The second
''
reagent blank corrected reactivity is expressed as R = R - RR 2 .
158
6.4. Calibration
6.4.1. Calibration Types

For this analyzer, calibration is either classified as linear or non-linear. Linear calibration also
includes single point, dual point, and multi-point linear scales which are principally used
when the reaction takes place in a solution; Non-Linear calibration mainly includes Logit-4P,
Logit-5P, Exponential-P, Polynomial-5P and Spline methods which are principally used when
the reaction solution is a suspension, such as for turbidimetric immunoassays.
6.4.2. Calculation of Calibration Parameters

There are different calibration parameter numbers and calculation methods for different
calibration types, as described separately below.
1) Single-Point Linear Calibration
The formula R = KC includes one calibration parameter, K.
RStandard
K
C Standard
Where: The C term is the concentration of the standard and the R term is the standard’s
reaction amplitude.
Notes:
A single-point linear calibration must be simultaneously performed with a

reagent blank test.
2) Dual-Point Linear Calibration
The formula R = KC + b includes two calibration parameters, K and b.
R 2 R 1
K
C 2  C1
C1 ( R2  R1 )
b  R1 
C 2  C1
Where: C1 and C2 represent the concentrations of the standards 1 and 2 and R1 and R2
represent the reaction amplitudes of standards 1 and 2.
3) Multi-Point Linear Calibration
The formula R = KC + b includes two calibration parameters, K and b.
Calculates calibration parameters using a multi-point linear regression.
4) Logit-4P
159
The calibration formula R = R0 + K / [1 + e - (a + blnC)] features 4 parameters, R0, K, a

and b. Use of this formula requires the provision of 4 standards. The first standard’s
concentration (activity) is zero and its corresponding R is R0. All other parameters can
be obtained using an iterative method.
5) Logit-5P
The calibration formula R = R0 + K / [1 + e - (a + blnC + c*C)] features 5 parameters, R0,

K, a, b and c. Use of this formula requires the provision of 5 standards. The first
standard’s concentration (activity) is zero and its corresponding R is R0. All other
parameters can be obtained using an iterative method.
6) Exponential-5P
The calibration formula R = R0 + Ke [alnC + b(lnC)2 + c(lnC)3] features 5 parameters,

R0, K, a, b and c. Use of this formula requires the provision of 5 standards. The first
standard’s concentration (activity) is zero and its corresponding R is R0. All other
parameters can be obtained using an iterative method.
7) Polynomial-5P
The calibration formula LnC = a + b(R - R0) + c(R - R0)2 + d(R - R0)3 features 5
parameters, R0, a, b, c and d. Use of this formula requires the provision of 5 standards.
The first standard’s concentration (activity) is zero and its corresponding R is R0. All
other parameters can be obtained using an iterative method.
8) Spline
The calibration formula C - Ci = R0i + ai(C - Ci) + bi(C - Ci) 2 + ci(C - Ci)3 - R features 4 i
parameters, R0i, ai, bi and ci. Use of this formula requires the provision of 2 standards.
With parameters for all intervals obtained using an iterative method.
6.5. Results Calculation
1) Calculation Factor: When using the calculation factor to calculate results, you can
directly enter calculation factor F without performing a calibration.
Results can be calculated using the following calculation formula:
FR
C
10000
Where: F is the calculation factor entered and R is the reaction amplitude of the test
sample.
Notes:
When using the calculation factor to calculate results, the chemistry in
question needs to have at least one effective reagent blank result, meaning
that the project must have at least one successful reagent blank test.
2) When using other calibration types, calibration parameters and reaction amplitude R can
be used to calculate the results.
160
6.6. QC
6.6.1. Quality Control Rules and Determination

The system supports the Westgard multi-rule standard (L-J), cumulative sum quality control
and Twin Plot quality control rules. The default quality control rule is the Westgard multi-rule
standard and the user can choose one or more rules with which to perform a quality control
status determination for different items as appropriate.
6.6.1.1. Westgard Multi-Rule

Westgard multi-rule quality control rules include 6 sub-rules; the definition of each sub-rule
is given below:
Rule Explanation QC determination
1-2S 1 point falls beyond mean +2 SD or -2 SD Warnings
1-3S 1 point falls beyond mean +3 SD or -3 SD Outliers (random error,

system error)
2-2S 2 consecutive points fall beyond mean +2 Outliers (system error)

SD or -2 SD
R4S The difference between two values within Outliers (random error)
the same batch exceeds 4SD
4-1S 4 consecutive points fall beyond mean +1 Outliers (system error)

SD or -1 SD
10X 10 consecutive points fall on the same Outliers (system error)

side of mean
A flow chart for determining the aforementioned sub-rules is as follows:
QC Data
No
12S Under Control
Yes No No No No No
22s R4S 41S 10x
13s
Yes Yes Yes Yes Yes

Out of Control
161
6.6.1.2. Cumulative Sum
6.6.1.3. Twin Plot
6.6.2. Quality Control Query

There are a total of three quality control search modes: real-time QC, intraday QC and
inter-day QC. An analysis of quality control status is performed using preset QC rules.
Real-time QC Used to perform a quality control status analysis on 10 consecutive quality

control data points in a day;
Daily QC Used to perform a quality control status analysis on all quality control data
points in a given day;
Day to Day QC Used to perform a quality control status analysis on all quality control
data points across different days;
6.6.3. QC Charting
There are three types of quality control charts: L-J (Westgard Multi-Rule), cumulative sum,
and Twin-Plot QC charts.
1) LJ Quality Control Chart
Using the quality control data value measured as the vertical axis, a horizontal line is
drawn from the quality control target value and 6 parallel lines are drawn to the mean
line at the upper +1SD (Standard deviation, abbreviated as SD), +2SD, +3SD and at the
lower -1SD, -2SD, -3SD. Furthermore, ±1SD、±2SD and ±3 SD are marked clearly and
each quality control product test result is marked on the quality control chart. Adjacent
points are connected with a thin line.
2) CUMSUM Control Chart
In calculating the cumulative sum of a control solution, the cumulative sum value is
taken as the vertical axis, and the number of tests as the horizontal axis. A horizontal
line is drawn from 0 and at the upper and lower cumulative sum’s control limit point h
(this limit is automatically calculated according to the quality control rules that the user
has entered in the QC setup), two parallel lines are drawn to the horizontal, each
cumulative sum point is labeled on the chart and the adjacent points are connected via
a thin line to yield a cumulative sum quality control chart. Any points that are outside the
upper and lower parallel lines are regarded as outliers.
3) Twin-Plot QC chart
When simultaneously analyzing control solutions of two concentrations under a single

item, the Twin-Plot QC chart can be displayed. According to each quality control
solution’s target value and standard deviation SD (entered by the user in the QC set up)
and taking one of the quality control solution’s test values as the horizontal axis (usually
the lower-concentration quality control solution), the other quality control solution’s test
162
values as the horizontal and vertical axes (usually the higher-concentration quality
control solution), and the mean value as the center line, ±1SD、±2SD and ±3SD lines
are labeled and one point is established using the test results of the two quality control
solutions corresponding to the same test. The point lies on the coordinates as shown in
the Figure below:
3SD
2SD
1SD
-1SD
-2SD
-3SD
-3SD -2SD -1SD 1SD 2SD 3SD
This chart can sensitively reflect systematic and random errors. Data that falls within the
blue circle (±2SD) is regarded as nominal; Data that falls within the first or third quadrant
between the red and blue circles is regarded as affected by systematic error; Data that falls
within the second or fourth quadrants between the red and blue circles is regarded as
arising from random errors and data that falls outside the red circle is also regarded as
indicative of random errors.
163
6.7. Other Related Calculations
6.7.1. Calibration Curve-Related Calculations

1) Calibration Sensitivity
Refers to the difference in reactive amplitude between the maximum concentration

calibration liquid and the minimum concentration calibration liquid during the calibration
process. If this value is smaller than the value set by the user, it will be regarded as invalid.
2) Blank Solution Reaction Amplitude
Refers to the reaction amplitude of a calibration solution with concentration zero. If this
value is greater than the value set by the user it will be regarded as invalid.
3) Calibration Reproducibility
If the difference between the minimum and maximum tested reaction amplitude for a
single calibrator tested multiple times exceeds a set value, the calibration will be
regarded as invalid.
4) Standard Deviation of the Calibration Curve

Applies only to multi-point linear and nonlinear calibration curves. Refers to the sum of
squares of the difference in the calibrator reaction amplitude (R) and the amplitude
'
calculated based on the corresponding calibration curve ( Ri ) divided by the number of
degrees of freedom, which is then squared again. The specific formula for the
calculation is as follows:
 Multi-Point Linear Calibration
 Rij  Ri 
N n
' 2
i 1 j 1
SD= Nn  2
Where: Rij is the reaction amplitude for calibrator i during a particular test
'
(valid test), Ri is the reaction amplitude of calibrator i calculated based on
the corresponding calibration curve, N is the number of calibrators and n is the
effective number of repeated measurements made.
 Logit-4P
 Rij  Ri 
N n
' 2
i 1 j 1
SD= Nn  4
Where: Rij is the reaction amplitude for calibrator i during a particular test (valid
'
test), Ri is the reaction amplitude of calibrator i calculated based on the
corresponding calibration curve, N is the number of calibrators and n is the
164
 Logit-5P
 Rij  Ri 
N n
' 2
i 1 j 1
SD= Nn  5
'
 Exponential-5P and Polynomial-5P
 Rij  Ri 
N n
' 2
i 1 j 1
SD= Nn  5
'
 Spline
 Rij  Ri 
N n
' 2
i 1 j 1
SD= Nn  4
Where: Rij is the reaction amplitude for calibrator i during a particular test
'
(valid test), Ri is the reaction amplitude of calibrator i calculated based on
the corresponding calibration curve, N is the number of calibrators and n is
the effective number of repeated measurements made.
5) Calibration Curve Correlation Coefficient

Applies only to multi-point linear and nonlinear calibration curves. The formula for
calculating the coefficient is given below:
 Cij  C  Rij  R 
N n
2 2
i 1 j 1
R2 
  Cij  C   Rij  R 
N n N
2 2
i 1 j 1 i 1
Where: C is the concentration of calibrator, R is the reaction amplitude,

N is the number of calibrators and n is the effective number of repeated
measurements made.
165
6.7.2. Substrate Depletion Determination

Only applied for the kinetic method and two-point method. Some high concentration (activity)
samples quickly deplete their substrate such that the reaction rate is not what is desired
(zero-order or single-order). In order to correctly reflect the measurement results obtained,
there is a need to determine a substrate depletion threshold. The specific method for making
this determination is described below:
1) Upward Reaction
When the absorbance of one or more points within the established time range is greater
than a set value, a determination of substrate depletion is made.
2) Downward Reaction
When the absorbance of one or more points within the established time range is less
than a set value, a determination of substrate depletion is made.
6.7.3. Linearity Test

Only applies to the kinetic method. Whether or not the linearity of the reaction curve
examined satisfies a pre-set value within the established time range is determined using
data derived from all optical metering points. The specific calculation is performed as
follows:
1) Assuming the number of optical metering points within the established time range is
greater than 9:
Linear limit = (the rate of change in absorbance for the first six points - the rate of change
in absorbance for the last six points) / the rate of change in absorbance for all points
2) Assuming that the number of optical metering points within the established time range
is greater than or equal to 4 and less than or equal to 8:
Linear limit = (the rate of change in absorbance for the first three points - the rate of
change in absorbance for the last three points) / the rate of change in absorbance for
all points
3) Linearity is not calculated under the following conditions:

 Number of optical metering points ≤ 3
 The rate of change in absorbance is less than 0.006 / min or the differential of the
rate of change in absorbance is less than 0.006 / min
 Reagent blank testing, sample blank testing and zero concentration calibrator testing
166
6.7.4. Prozone Check

In an antigen-antibody reaction, the amount of resulting insoluble antigen-antibody complex
is closely associated with the antigen-antibody ratio. If an appropriate ratio is maintained,
the amount of insoluble antigen-antibody complex generated is maximized and when this
happens the amount of transmitted light is minimized and (necessarily) absorbance is
maximized; When this ideal ratio is exceeded or not met, the resulting amount of insoluble
antigen-antibody complex produced will be reduced and transmitted light increases so
absorbance decreases as shown in the Figure below. If a prozone check is not performed
beforehand, two samples which differ greatly in concentration can produce equal amounts
of insoluble antigen-antibody complexes and the measurement result will be the same.
Ag / Ab
Complex
Ab Excess Equivalence Ag Excess
Zone Zone Zone
Ag
A prozone check is performed according to the following method:

1) Double Reagent End-Point Method
As shown in the Figure below, L is the starting point of the reaction, M is the beginning
of the reaction time interval, N and P are the prozone check points. L, M, N and P must
satisfy the following relationship:
19 ≤ L＜N＜P＜M ≤40
Absorbance
P
N
Optical
Metering Point
167
The prozone check (PC) value is equal to:
AM  A P
PC  M  P  100%
AN  AL
NL
If PC > the set prozone check value limit, then the existence of a prozone effect is affirmed;
2) Single Reagent End-Point Method

As shown in the Figure below, L is the starting point of the reaction, M is the beginning
of the reaction time interval, N and P are the prozone check points. L, M, N and P must
satisfy the following relationship:
10 ≤ L＜N＜P＜M ≤40
M
Absorbance
P
N
Optical
Metering Point
The prozone check (PC) value is equal to:
AM  A P
PC  M  P  100%
AN  AL
NL
If PC > the set prozone check value limit, then the existence of a prozone effect
is affirmed;
168
6.7.5. Determination of Lamp State

After each startup, before starting a test, the reaction disk is rotated such that the reaction
cuvette stays in between positions 50# - 1#. When this happens, photoelectric collection is
performed for each wavelength and a total of 10 data points are collected for each wavelength.
The maximum and minimum values for each wavelength are excluded and the average of the
remaining 8 data points is taken as the current photoelectric value for each wavelength as a
basis for determining the light intensity of the system lamp. When a photoelectric value for any
given wavelength is less than 25,000, the system will alert the user that "Light source intensity
is low; please replace the lamp." The user will then be permitted to continue the current test
but before each subsequent test a warning will appear which states "Insufficient light intensity
may affect results. Continue test?" and the user can make a decision regarding whether or not
to proceed with the test; When the photoelectric value for any given wavelength decreases
below 15,000 an alarm will be issued to the user stating "Light source intensity is very low;
please replace the lamp immediately" and the user will be prohibited from continuing the test.
The user will be required to replace the light source bulb and carry out a light source intensity
test as required before testing can be continued.
6.7.6. Examination of Cuvette Cleanliness

After starting up the machine and before starting a test, the reaction disk is rotated such that
the reaction cuvette stays in between positions 50# - 1#. When this happens, photoelectric
collection is performed for each wavelength and a total of 10 data points are collected for
each wavelength. The maximum and minimum values for each wavelength are excluded
and the average of the remaining 8 data points is taken as the current photoelectric value for
each wavelength as a basis for determining the cleanliness of the system's reaction
cuvettes.
During the test, if the AD of the cuvette blank for any one of the 8 tested wavelengths is
smaller than 50% of its initial value, the user is alerted to the presence of a dirty cuvette.
Each time the blank of a cuvette is tested, the apparatus will attempt to determine whether
or not the cuvette is dirty. The determination of dirtiness is based on the ratio of the blank AD
value of the cuvette at the tested wavelength to the corresponding initial value.
169
Care and Maintenance
7. Care and Maintenance

To maximize the performance of the analyzer, ensure its reliability and extend its life,
maintenance should be performed in strict accordance with the requirements outlined in
this section.
7.1. Preparation of Tools
1) M1.5, M2.0, M2.5, M3.0 hex wrenches;
2) Phillips screwdriver (large, medium and small);
3) Stainless steel wire (of 0.3 mm and 0.5 mm diameters);
4) Plastic syringe (approx. 10ml, without probe);
5) Clean gauze;
6) Clean cotton swabs;
7) Brush (used to clean containers);
8) Non-ionic surfactant cleaner;
9) Anhydrous ethanol;
10) 84 Disinfectant;
11) Medical latex gloves;
12) Lubricating grease.
7.2. Daily Maintenance
7.2.1. Wiping Down the Analyzer Countertop

The analyzer countertop can easily become dirty due to spilling of reagents, reaction
solution and serum, and should be cleaned promptly. The instrument should be cleaned
every day after shutdown, in accordance with the following steps:
1) Wet a towel with cleaning solution and wipe the analyzer countertop until all visible dirt
is wiped clean;
2) Wet a towel with disinfectant and wipe down the analyzer countertop;
3) After fifteen minutes, wring out a wet towel and wipe down the countertop to remove
any residual disinfectant.
Notes: Corrosion
Wash solution is chemically corrosive and protective gloves should be worn
during use.
170

The countertop should be considered a source of contagion and gloves
should be worn during handling.
7.2.2. Cleaning the Sample Probe / Mixer

When the exterior and tip of the sample probe or surface of the mixer are dirty, they may
contain serum, reagent or cleaning water and should be checked daily after system
shutdown. If any of the above issues are observed, cleaning should be carried out promptly.
Notes: Combustibles
Ethanol is flammable. When cleaning with ethanol, ensure that the
analyzer has been shut down and the amount of ethanol within proximity
to the analyzer should be kept to within 10ml or less.

All analyzer parts should be considered a source of contagion and gloves
7.2.2.1. Cleaning the Sample Probe
Figure 7-1: Wiping Down the Sample probe
1) Move the Sample probe to the appropriate position;

2) Soak a piece of clean gauze in ethanol and gently wipe the sample probe tip until
nothing remains on the probe tip.
171
7.2.2.2. Cleaning the Mixer
Figure 7-2: Wiping Down the Mixer
1) Move the mixer to the appropriate position;
2) Soak a piece of clean gauze in ethanol and gently wipe the flat part of the mixer until
nothing remains on the rod.
7.2.3. Inspecting the Reagent / Sample Syringe

Open the cover on the left side of the analysis unit. The syringe should be visible on the
right.
Syringe
Figure 7-3: The Syringe
172
Check the knob of the Finger-tight fitting, if syringe any leaks are identified,
tighten it. If bubbles inside, please remove all bubbles. If not be solved, please
contact Manufacturer; When finished, close the cover on the left side of the
analysis unit.
7.2.4. Inspecting the Purified Water Bucket
A purified water bucket should be present on the left side of the analysis unit:
Figure 7-4: The Purified Water Bucket
Check the clean water bucket in accordance with the following procedure:
1) Check whether or not the bottom of the bucket is clean;
2) If the bottom of the bucket is dirty, clean the bucket thoroughly before continuing use.
7.2.5. Inspecting the Waste Liquid Container / Tubing

A waste liquid container should be present next to the purified water bucket on the left side
of the analysis unit:
173
Figure 7-5: Waste Liquid Container / Tubing
Check the waste liquid container in accordance with the following procedure:
1) Check whether or not there is any fluid leakage at the joints connecting the analyzer to
the system's waste liquid tubing.
2) If a leak is identified, wipe off any liquid on the connector with gauze and unscrew the
connector in the counterclockwise direction. Check whether or not the waste liquid
tubing is blocked and, after removing any blockage, screw the connector back on. If the
leak persists, contact Manufacturer for service.
3) Check whether or not the system's waste liquid tubing is bent. If there are any kinks,
straighten them out.

1) All waste liquid should be considered a source of contagion and gloves
2) The disposal of any liquid waste should comply with the requirements of
your local regulatory agency for environmental protection.
7.3. Weekly Maintenance
Note: Combustibles
Ethanol is flammable. When handling ethanol, ensure that the analyzer has
been shut down and that the amount of ethanol within proximity to the
analyzer is kept to within 10ml or less.
Note: Biological Contamination

7.3.1. Cleaning the Cuvette Cleaning Probes

For analyzer with auto wash function, when the cuvette cleaning mechanism probe is dirty, it
may contain reaction solution or excess water and should be checked daily after system
shutdown. If any of the above issues are observed, cleaning should be carried out promptly.
1) Soak a piece of clean gauze in ethanol and gently wipe the drainage probe and tip until
no foreign matter remains on the probe.
174
Figure 7-6: Wiping Clean the Cuvette Cleaning Mechanism Nozzle
2) Soak a piece of clean gauze in ethanol and gently wipe all four sides and the top and
bottom of the nozzle until no foreign matter remains on the rod.
Notes:
When cleaning, it is important to note that there is a risk that cotton swab
fibers may become stuck between the drainage and suction probes.
If found, these should be promptly removed.
7.3.2. Cleaning the Primary Purified Water Filter
Figure 7-7: Removing the Filter
175
Figure 7-8: Replacing the Filter
Notes:
When installing the filter, it is important to ensure that the filter and the
purified water detector have sunk to the bottom of the container. Failure to
do so may result in inaccurate results!
Remove the tubing connected to the purified water bucket and remove the filter,
as shown in Figures 7-7 and 7-8;
Check that the filter to be placed in the purified water bucket is completely clean.
If it is dirty:
First rinse off the filter thoroughly in tap water then rinse once again using purified water until
completely clean;
Connect the filter to the connecting tubing and place it in the clean water bucket;
7.3.3. Cleaning the Waste Liquid Container

If waste liquid is discharged directly into a sewer system, this maintenance step may be
omitted. Otherwise, cleaning should be performed in the following order:
1) Open the waste liquid container lid and remove the waste liquid tubing;
2) Clean the tubing thoroughly with a brush and place it back in the container.

All waste liquid should be considered a source of contagion and gloves
7.3.4. Cleaning the Reagent / Sample Disk Refrigeration Unit

1) Turn off the analysis unit's power supply;
2) Remove the reagent / sample disk lid and remove the reagent / sample disk. Use a
piece of clean gauze dipped in wash solution to clean the internal walls of the
refrigeration unit until there are no visible stains present. Next, use a clean piece of
gauze to wipe the interior dry as shown in the following Figure :
176
Figure 7-9: Clean and dry reagent tray
3) Reinstall the reagent / sample disk
4) Place the cover back on the reagent / sample disk

All stains encountered should be considered a source of contagion and
gloves should be worn during handling;
7.4. Monthly Maintenance

7.4.1. Cleaning the Cleaning Pool

The cleaning pool should be cleaned in the following order:
2) Remove the reagent probe / sample probe from the cleaning position;
3) Use a cotton swab dipped in cleaning solution to gently wipe the interior of the
reagent probe / sample probe cleaning pool until no stains are visible, then wipe
the surface dry with clean gauze;
4) Remove the mixer from the cleaning position;
5) Use a cotton swab dipped in cleaning solution to gently wipe the interior of the
mixer cleaning pool until no stains are visible, then wipe the surface dry with
clean gauze;
6) Move the Sample probe and mixer to the tops of the corresponding cleaning pools.
7.4.2. Cleaning the Thermostatic Groove of the Reaction Disk

The thermostatic groove of the reaction disk should be cleaned in the following order:
2) Remove the reaction disk cover;
3) Loosen the screws that fix the reaction disk in place, as shown below:
177
Figure 7-10: Loosen screws
4) Take out the reaction disk, as shown below:
Figure 7-11: Take out reaction disk
5) With a clean gauze dipped in wash solution, clean each part of the inner wall of the
reaction Compartment until no stains are visible. Then, wipe the inner wall dry
with clean gauze, as shown below:
Figure 7-12: Clean and dry
178
6) Reinstall the reaction disk and fix in place with the corresponding fastening screws;
7) Place the cover on the reaction disk;
7.4.3. Wiping the Driving Rod

Wipe the driving rod in the following order:
2) Move the mixer such that the driving rod is at an angle suitable for wiping;
3) Gently use a piece of clean gauze to wipe the driving rod up and down in the
vertical direction until no stains are visible.
4) Use the same method to wipe the Sample probe driving rod;
5) Move the Sample probe and mixer to the tops of the corresponding cleaning pools.
7.4.4. Check and Replace Cooling Water

For analyzer with external submersible pump: the cooling water inside the external water
cooling tank should be checked:
2) Disconnect the power cable of submersible pump, take out the water cooling in
tube with the submersible pump from the external water cooling tank.
3) Take out the water cooling out tube from the tank.
4) Clean the external water cooling tank and make sure no dust left inside.
5) Put back the water cooling in tube with submersible pump into the tank.
6) Put back the water cooling out tube into the tank.
7) Refill the tank with purified water.
8) Connect the power cable for submersible pump to the DC12V port.
7.4.5. Clean the Dust Filter

2) Remove the dust filter from the backside of the analyzer and wash it by using
purified water;
3) Put the dust filter back when it is dry.
7.5. Semi-Annual Maintenance
7.5.1. Replacing the Primary Filter

The method for replacing the primary stage filter is the same as the method described in
179
Section 7.3.1.
7.5.2. Replacing the 45 Micron Filter

When the 45 micron filter is obviously dirty or the amount of clean water on the interior is
obviously reduced, the filter needs to be replaced. The replacement should be performed
according to the following sequence:
2) Open the left door of the analysis unit and locate the 45 micron filter. Release the
clips on either side of the second stage filter and simply remove the old filter as
shown in the Figure below:
3) Install a new filter and reinstall the clips on either side of the filter.
4) Close the left door of the analysis unit.
7.6. Unscheduled Maintenance
7.6.1. Unblocking the Sample and Reagent Probes

When clogging of a probe occurs, it should be cleared immediately in the following
sequence:
2) Remove the reagent disk vertically;
3) Manually pull the sample probe's rocker arm to its uppermost position and then
rotate it towards the interior of the reagent disk;
4) Use the space available in the reagent disk to insert a standard acupuncture probe
into the Sample probe to unblock it as shown in the Figure below:
180
5) Rotate the reagent probe or Sample probe into the space above the cleaning pool
and install the reagent disk.

The reagent probe and Sample probe should be considered a source of
contagion and gloves should be worn during handling.
7.6.2. Replacing the Sample Probe

In the event that the probe becomes irreversibly clogged, broken or bent, you will need to
replace it immediately in accordance with the following sequence:
2) Rotate the Sample probe to an appropriate location and open the Sample probe
rocker arm cover, as shown below:
181
3) Loosen the compression spring, as shown below:
4) Loosen the Teflon tube connected to the Sample probe, as shown below:
5) Unplug the connection to the liquid level detection plate, as shown below:
182
6) Remove the reagent probe or Sample probe in the upward direction as shown in
the Figure below:
7) Install the new probe on the rocker arm, reapply the spring, connect the
Teflon tube, plug in the liquid level detection sensor leads and close the rocker
arm cover;
8) Move the Sample probe to the space above the cleaning pool.

The Sample probe should be considered a source of contagion and gloves
should be worn during handling.
7.6.3. Replacing the Mixer

In the event that the mixer probe becomes broken or bent or frequently holds onto liquids,
you will need to replace it immediately in accordance with the following sequence:
2) Move the mixer to the appropriate position;
3) Loosen the two top wire screws fixed to the stirring motor shaft, as shown below:
183
4) Remove the mixer.
5) Install the new mixer upward in the motor shaft until you meet with resistance;
6) Use two top wire screws to fix the mixer onto the stirring motor shaft;

The mixer should be considered a source of contagion and gloves should
be worn during handling.
7.6.4. Replacing the Lamp

When the lamp has been in use for more than six months or the analyzer prompts you to
replace the lamp, the lamp should be replaced immediately according to the following
sequence:
1) Turn off the analysis unit's power supply and perform the subsequent steps after
waiting for 30 minutes;
2) Remove the reaction disk cover and remove the reaction disk using steps 2 to 4 of
Section 7.4.2;
3) After removing the reaction disk, unscrew the 2 screws on either side of the lamp
base, as shown below:
184
4) After removing the lamp, disconnect the lamp power cord, as shown below:
5) Insert the new lamp, apply the fixing screws and tighten the lamp power cord to
power connector;
6) Put the reaction disk back into place and apply the fixing screws;
7) Place the cover on the reaction disk.
8) Adjust the AD again to keep it in the range 57000 ~ 59000
Notes: High temperature. Take care to avoid burns

Before replacing the lamps, turn off the power switch of the apparatus, and
wait at least 30 minutes until the lamp has cooled down.
Notes: Glare
Before replacing the lamp, make sure the analysis unit is turned off, as
light beams emitted by the bulb can damage your eyes.
Note: Dropping of Screws

When loosening and tightening the screws that secure the lamp, take care
to avoid dropping the screws.
7.7. Replaceable Part List
7.7.1. The following is a list of items that can be replaced

by the user
1) Sample probe and mixer;
2) Lamp;
3) The second stage filter.
Replacing the Fuse

1) The fuse that is integrated into the main power switch is an overcurrent
release fuse and does not need to be replaced by the user;
2) If you need to replace the fuse, please notify a Manufacturer
185
maintenance engineer.
7.7.2. List of Parts that Require a Maintenance Engineer for

Replacement
1) Main power supply switch;
2) Analysis unit power supply switch;
3) Other parts.
186
7.8. Maintenance Log
The following table lists components that need maintenance and provides a recommended maintenance schedule. Please make a copy of these tables
monthly and record when maintenance is performed using the corresponding column of the maintenance log.
————Year——Month
Maintenance Maintenance Record

Performed (Daily) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Wiping Down of the

Analyzer Countertop
Cleaning of the
Sample probe /
Mixer
Inspection of the
Reagent / Sample
Syringe
Inspection of the
Purified Water
Bucket
Inspection of the
Waste Liquid
Container / Tubing
187
Maintenance Record
Maintenance
Performed (Weekly) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Cleaning of the
Cleaning Head
Mechanism
Cleaning of the
Purified Water Filter
Cleaning of the
Waste Liquid
Container
Cleaning of
the Reagent /
Sample disk
Refrigeration Unit
Maintenance Record
Maintenance
Performed (Monthly) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Cleaning of the
Wash well
Cleaning of the
Reaction
Compartment
Wiping the of Driving
Rod
Check and Replace
Cooling Water
Clean Dust Filter
188
Maintenance
Performed Maintenance Record
(Semi-Annually) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Cleaning of the
Wash1 well
Cleaning of the
Reaction
2
Compartment
Wiping of the
3
Driving Rod
Maintenance Maintenance Record

Performed
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
(Unscheduled)
Unblocking of
the Sample
1 /
Reagent probes
Replacement of the
Sample
2 /
Reagent probes
Replacement of the
Mixer3
Replacement of the
Lamp4
Replacement of the
5
Syringe
Replacement of the
6
45 micron Filter
189
Alarm Information and Processing
8. Alarm Information and Processing
8.1. Overview
This chapter lists all system fault alarm information and corresponding troubleshooting
measures. Please implement corresponding troubleshooting measures as soon as possible
based on the measures provided here. In the event that the alarm status cannot be resolved
after performing the required steps, please contact Manufacturer.
8.2. Alarm Information Inquiry
When the system gives a warning message, click on the lower right corner of the error log
view button to find the message and to view the corresponding message code which can be
used to find corresponding appropriate user actions using the table below. Detailed
information concerning potential runtime errors are summarized below:
8.2.1. Error Code Definition
Error Level Code Error Code

Slave Machine Code
Host Machine Code
8.2.1.1. Error Level Code Definitions
Level Code Error Class Class Definitions
Reminder: The malfunction will not affect the

INF 1 operation of the instrument or the calculation of test
results, but the user should be aware of the error.
Warning: The malfunction will not affect the

operation of the instrument or the calculation of
WAR 2 test results, but the user should take responsive
measures as appropriate, as failure to do so may
affect subsequent tests.
Error: The current malfunction may affect the

ERR 3
current testing process or corresponding results.
Fatal: The system may not be able to continue

FAT 4 operation due to the issue in question or may turn
off automatically.
190
8.2.1.2. Host Machine Code Module Definitions
Host Machine Code Definition

Code
11 Cycle test module
21 Machine task logic module
8.2.1.3 Slave Machine Unit Code Definitions
Slave Machine Code Code Definition

00 Main control unit
01 ISE unit
8.2.2. Instrument Runtime Error Table
Error Code Level Description Solution
Restart the system. If the problem

Failed to obtain dilution
ERR1100001 ERR persists, please contact Manufacturer's
cuvette number
technical support department.
Check the communication cable and
Communication restart the system. If the problem
ERR1100002 ERR
abnormal persists, please contact Manufacturer's
1. Turn on the system power;
Cycle command 2. Check the cable and restart the
ERR1100003 ERR system. If the problem persists, please
response timeout
contact Manufacturer's technical
support department.
Processing cycle If the system receives abnormal data,
ERR1100004 FAT command results frame please contact the Manufacturer
data abnormal technical support department.
If the system receives abnormal data,
Cycle command results
ERR1100005 FAT please contact the Manufacturer
frame data abnormal
Restart the system. If the problem
Precompiled cycle
ERR1100006 FAT persists, please contact Manufacturer's
command abnormal
A unit of the recovery
cycle has malfunctioned Exit the host computer and restart.
ERR1101001 ERR
and the test will be Perform a power on self-test
immediately terminated
191
Check the wiring and connectors. First

perform a sample probe vertical reset
command and then re-execute the
Sample probe rotation
ERR1101002 ERR corresponding rotate command. If the
prohibited alert
error reoccurs, please contact the
Manufacturer technical support
department.
The sample probe has Add acid-base cleaning solution. If the
detected that the problem continues to reoccur, please
ERR1101003 ERR
acid-base cleaning contact Manufacturer's technical
solution is low support department.
1) Add acid-base cleaning solution;
2) Check all applicable wires and
Insufficient acid-base sensors. If the problem continues
ERR1101008 ERR
cleaning solution error to reoccur, please contact
Manufacturer's technical support
department.
1) Turn on the system power;
2) Check all connected cables and
Cycle command restart the system. If the problem
ERR1101009 ERR
response timeout persists, please contact
department.
If the system receives abnormal data,
Cycle command results
ERR1101010 ERR please contact the Manufacturer
frame data abnormal
Eliminate strong photo or
electromagnetic interference factors
and check that the sensor plug is not
The sample probe is loose. If it is not loose, check that the
ERR1101011 ERR unable to detect the sensor wires are not disconnected and
initial vertical position restart the machine. If the error
reoccurs, please contact the
department.
1) Check whether or not the reagent
bottle is open and whether or not
the reagent
is misplaced;
2) Check whether or not the sample
tube lid is open and whether or not
the sample
ERR1101012 ERR Sample probe collision is misplaced;
3) Place the reagent / sample disk cover
and reaction disk cover in the correct
positions;
4) Remove possible
electromagnetic interference
factors. If the problem persists,
please contact Manufacturer's
192

The sample probe is loose. If it is not loose, check that the
ERR1101013 ERR unable to leave the initial sensor wires are not disconnected
vertical position and restart the machine. If the error
department.
1) Check the water level in the
cleaning solution container.
If there is insufficient water in
the container, add more
immediately;
2) Check the tip of the sample
probe. If it is dirty, wipe gently
Sample probe detects the
ERR1101014 ERR with cotton wool dipped in
reagent level incorrectly
ethanol;
3) Remove possible source of
electromagnetic interference.
If the problem continues to
reoccur, please contact
Manufacturer's technical
support department.
The sample probe has Add reagent. If the problem
detected that the continues to reoccur, please contact
ERR1101015 ERR
amount of reagent is Manufacturer's technical support
insufficient department.
1) Check the placement of the
reagent;
2) Add reagent,
The Sample probe has
ERR1101016 ERR detected a complete 3) Check all applicable wires
lack of reagent and sensors. If the problem
continues to reoccur, please
support department.
1. Execute a Sample probe vertical
reset command, then execute the
Sample probe unable to
relevant descend command. If the
ERR1101017 ERR descend to specified
problem continues to reoccur,
position error
Although there was no First, execute a Sample probe vertical
sample drawn during the reset command and eliminate strong
ERR1101018 ERR current cycle, when sources of photo or electromagnetic
moving down toward the interference, then restart the machine.
reaction cuvette, the If the error reoccurs, please contact
193
Sample probe was not in the Manufacturer technical support

the initial vertical position. department.
First, execute a Sample probe

Although there was a
vertical reset command, and
sample drawn during the
eliminate strong sources of photo or
current cycle, when
electromagnetic interference then
ERR1101019 ERR moving down toward the
restart the machine. If the error
reaction cuvette, the
Sample probe was not in
the initial vertical position.
department.
Although a sample was
drawn, when cleaning of
vertical reset command and
the Sample probe was
started, it was discovered
electromagnetic interference, then
ERR1101020 ERR that the Sample probe
was not in the initial
position, so it cannot be
lowered and cleaning
department.
cannot be completed.
not drawn, when starting
cleaning of the Sample
probe, it was discovered
ERR1101021 ERR that the Sample probe
position, so it cannot be
lowered and cleaning
department.
cannot be completed.
The Sample probe is not
in the initial position and
cannot be lowered to the
ERR1101022 ERR specified position in order
to complete the enhanced
Sample probe cleaning
process.
department.
drawn, the Sample probe
position and the Sample
ERR1101023 ERR probe could not be
completely lowered into
the cleaning pool solution
and the cleaning operation
department.
could not be completed.
Although no sample was First, execute a Sample probe
drawn, the Sample probe vertical reset command and
was not in the initial eliminate strong sources of photo or
ERR1101024 ERR position and the Sample electromagnetic interference, then
probe could not be restart the machine. If the error
completely lowered into reoccurs, please contact the
the cleaning pool solution Manufacturer technical support
194
and the cleaning department.

operation could not be
completed.

The initial position sensor and check that the sensor plug is not
was not detected when loose. If it is not loose, check that the
ERR1101025 ERR the sample probe was sensor wires are not disconnected
horizontally rotated into and restart the machine. If the error
the initial position reoccurs, please contact the
department.
The sample probe is
unable to leave the
loose. If it is not loose, check that the
initial position when
ERR1101026 ERR sensor wires are not disconnected
performing a rotation
and restart the machine. If the error
reset in the initial
position
department.
Sample probe error when loose. If it is not loose, check that the
ERR1101027 ERR rotating to cleaning sensor wires are not disconnected
position and restart the machine. If the error
department.
The sample probe
experienced an error
when rotating to specified
reagent position
department.
The sample probe
experienced an error
when rotating to specified
sample position
department.
Execute a sample probe rotation
Sample probe horizontal reset command, then execute the
ERR1101030 ERR relevant rotation command. If the
position unknown error
195

ERR1101031 ERR rotating to reaction disk sensor wires are not disconnected
position and restart the machine. If the error
department.
1) Check the water level in the
cleaning solution container. If
there is insufficient water in the
container, add more immediately;
2) Check the tip of the sample probe.
Sample probe detection
If it is dirty, wipe gently with cotton
ERR1101032 ERR error: sample liquid level
wool dipped in ethanol;
detected incorrectly
3) Remove possible source of
electromagnetic interference. If
the problem continues to reoccur,
After eliminating strong sources of
photo or electromagnetic interference,
check the guidewire and valve and
ERR1101033 ERR Turn On error reboot the machine. If the error
department.
ERR1101034 ERR Turn on pump error reboot the machine. If the error
department.
Turn on pump and close
ERR1101035 ERR reboot the machine. If the error
solenoid valve error
department.
There were errors when check the guidewire and valve and
ERR1101036 ERR closing the pump and reboot the machine. If the error
solenoid valve reoccurs, please contact the
department.
196

ERR1101037 ERR Turn Off error reboot the machine. If the error
department.
ERR1101038 ERR Turn off pump error reboot the machine. If the error
department.
Sample probe error when check the guidewire and valve and
ERR1101039 ERR opening the cleaning reboot the machine. If the error
valve on the inner wall reoccurs, please contact the
department.
ERR1101040 ERR Syringe is out of step sensor wires are not disconnected and
department.
1) Perform a check after shutting
down the machine and fix the
serial cable in place;
Sample probe unit
ERR1101042 ERR command reception 2) Eliminate strong electromagnetic
efficacy and error interference, reboot the system. If
The Sample probe has Add additional sample. If the
detected that the problem continues to reoccur,
ERR1101043 ERR
amount of sample is please contact Manufacturer's
insufficient technical support department.
sample;
2) Add sample;
The Sample probe has
ERR1101044 ERR detected a complete 3) Check all applicable wires and
lack of sample sensors. If the problem
continues to reoccur, please
support department.
197
The reagent cuvette number is out of

Incorrect reagent cuvette
ERR1101045 ERR range. Please issue a cuvette
position
number from 1 - 40.
Sample probe moves to Check for light interference;
ERR1101046 ERR the initial vertical position otherwise contact the Manufacturer
early error and handle accordingly.
198

The syringe has moved to loose. If it is not loose, check that the
ERR1101047 ERR the initial vertical position sensor wires are not disconnected and
too early restart the machine. If the error
department.
Sample syringe unable to loose. If it is not loose, check that the
ERR1101048 ERR leave initial vertical sensor wires are not disconnected and
position error restart the machine. If the error
department.
The sample cuvette number is out of

Incorrect sample cuvette
ERR1101049 ERR range. Please issue a cuvette
position
number from 1 - 40.
Sample probe unit invalid Please issue a correct unit

ERR1101051 ERR
command command.

ERR1101052 ERR rotating to reaction disk sensor wires are not disconnected and
Add S position restart the machine. If the error
department.
ERR1101053 ERR rotating to acid-base sensor wires are not disconnected and
cleaning position restart the machine. If the error
department.
Sample probe error when
ERR1101054 ERR sensor wires are not disconnected and
rotating to ISE position
department.
199
During an online dilution, Add additional sample. If the

the sample probe problem continues to reoccur,
ERR1101055 ERR
detected an insufficient please contact Manufacturer's
amount of sample technical support department.
200

sample;
During an online dilution, 2) Add sample;
the sample probe 3) Check all applicable wires and
ERR1101056 ERR
detected a complete lack sensors. If the problem
of sample continues to reoccur, please
support department.

Clockwise rotation error
when performing a
sample probe initial
position reset
department.
Insufficient sample in
Please contact the Manufacturer
ERR1101058 ERR cuvette during online
dilution

Reagent disk unit 2) Eliminate strong
ERR1101110 ERR command reception electromagnetic interference,
efficacy and error then reboot the system. If the
Vacuum pump turn off Please contact the Manufacturer

ERR1101113 ERR
error technical support department.
Vacuum pump turn on Please contact the Manufacturer

ERR1101114 ERR
error technical support department.

Encoding disk error when loose. If it is not loose, check that the
ERR1101115 ERR reagent sample disk is sensor wires are not disconnected and
rotating restart the machine. If the error
department.
201

Initial position sensor loose. If it is not loose, check that the
ERR1101116 ERR error when reagent sensor wires are not disconnected and
sample disk is rotating restart the machine. If the error
department.
202

There was an error with
the reagent disk when
rotating to specified
sample position
department.
Reagent disk error when
rotating to initial position
or when passing through
the initial position when
rotating to a specified
cuvette
department.
ERR1101120 ERR Mixer vertical reset error sensor wires are not disconnected and
department.
Mixer unable to leave loose. If it is not loose, check that the
ERR1101121 ERR initial vertical position sensor wires are not disconnected and
error restart the machine. If the error
department.
Check the wiring or plug. Execute a
mixer vertical reset command. If the
Mixer unable to descend
ERR1101122 ERR problem continues to reoccur,
to specified position error
check the guidewire and board and
ERR1101123 ERR Mixing motor turn on error reboot the machine. If the error
department.
ERR1101124 ERR Mixing motor turn off error photo or electromagnetic interference,
reboot the machine. If the error
203

department.

Pump turn off error
(cleaning of the outer
ERR1101125 ERR reboot the machine. If the error
wall of the mixer
was stopped)
department.
Error when closing the photo or electromagnetic interference,
cleaning valve on the check the guidewire and board and
ERR1101126 ERR outer wall of the mixer reboot the machine. If the error
and turning off the reoccurs, please contact the
mixing motor Manufacturer technical support
department.
Pump turn on error check the guidewire and board and
ERR1101127 ERR (cleaning the outer wall of reboot the machine. If the error
the mixer) reoccurs, please contact the
department.
Error when opening the photo or electromagnetic interference,
cleaning valve on the check the guidewire and board and
ERR1101128 ERR outer wall of the mixer reboot the machine. If the error
and turning on the mixing reoccurs, please contact the
motor Manufacturer technical support
department.
Initial position not found
error when performing a
mixer horizontal rotation
reset
department.
Mixer not left initial
position error when
performing a horizontal
rotation reset
department.
204

Mixer error when rotating
to cleaning position
department.
to cleaning position
during deceleration
interval
department.
to reaction disk position
department.
to reaction disk position
during deceleration
interval
department.
To complete this operation, please
Mixer horizontal position issue a mixer horizontal rotation
ERR1101135 ERR
unknown error reset command and then carry out
this operation.
Mixer moves to the Check for light interference;
ERR1101136 ERR initial vertical position otherwise contact the Manufacturer
early error and handle accordingly.
First perform a mixer vertical reset
command, check the wiring and
connectors, and then re-execute the
Mixer rotation prohibited
ERR1101137 ERR corresponding rotate command. If
alert
the error reoccurs, please contact
the Manufacturer technical support
department.
205

Mixer unit command 2) Eliminate strong
ERR1101143 ERR reception efficacy and electromagnetic interference,
error then reboot the system. If the
206
First perform a cleaning nozzle

vertical reset command, check the
wiring and connectors, and then
Reaction disk rotation
ERR1101153 ERR re-execute the corresponding rotate
prohibited alert
command. If the error reoccurs,
please contact the Manufacturer
Reaction disk command 2) Eliminate strong
ERR1101154 ERR reception efficacy and electromagnetic interference,
error or invalid command then reboot the system. If the
Cuvette encoding disk
error
department.
Reaction disk initial
position not found error
department.
Cuvette encoding disk loose. If it is not loose, check that the
ERR1101157 ERR error during deceleration sensor wires are not disconnected and
interval restart the machine. If the error
department.
Perform a reaction disk rotation reset
operation. Once the reset operation
has been completed normally,
Unconfirmed reaction disk
ERR1101158 ERR re-execute the current operation. If
stop position error
Incorrect Sample channel Please enter the correct Sample
ERR1101159 ERR
no. channel number.
207
Cleaning solution valve Please contact the Manufacturer

ERR1101160 ERR
opening error technical support department.
Cleaning solution valve Please contact the Manufacturer
ERR1101161 ERR
closing error technical support department.
ERR1101162 ERR Vacuum valve opening error
ERR1101163 ERR Vacuum valve closing error
ERR1101164 ERR Waste valve opening error
ERR1101165 ERR Waste valve closing error
Initial position sensor and check that the sensor plug is not
error or motor step loss loose. If it is not loose, check that the
ERR1101166 ERR when performing a sensor wires are not disconnected and
vertical reset operation on restart the machine. If the error
the cleaning head reoccurs, please contact the
department.
The cleaning head
reaches the initial position
while moving up 185
steps
department.
Cleaning head has not left
the initial position
department.
First, execute a cleaning head
The cleaning head is not vertical reset then execute other
ERR1101169 ERR in the initial position prior cleaning head operations. If the
to moving issue persists, please contact the
Perform a cleaning head vertical
reset, move the cleaning head into
Cleaning head moves into
ERR1101170 ERR the waste liquid suction position and
the initial position early
re-execute this operation. If the error
208

department.
Peristaltic pump waiting

ERR1101171 ERR times exceed the Reset peristaltic pump waiting times
permissible range
Check the cleaning head sensor,
connector and wiring then
Cleaning head vertical
ERR1101172 ERR re-execute the operation. If the
reset error
problem persists, please contact the
Manufacturer technical department.
ERR1101173 ERR Pump turn on error
ERR1101174 ERR Pump turn off error
Eliminate strong electromagnetic
interference. Check wiring. If the
ERR1101208 ERR High temperature alarm problem continues to reoccur,
First abnormal interference. Check wiring. If the
ERR1101209 ERR temperature alarm after problem continues to reoccur,
establishing temperature please contact Manufacturer's
Abnormal temperature
alarm
Continuously high
temperature alarm
Unable to change Stop analyzer and put into

ERR1101212 ERR
execution parameters standby mode.
Target temperature value

ERR1101213 ERR Reset the target temperature value
is too high
Check the guide wire; If the problem
persists, please contact
ERR1101214 ERR Cooling fan turn on error
department.
Immediately contact the
ERR1101215 ERR Cooling fan turn off error Manufacturer technical support
department.
209
Immediately contact the

ERR1101216 ERR High temperature alarm Manufacturer technical support
department.
210

Temperature control unit 2) Eliminate strong
ERR1101236 ERR command reception electromagnetic interference,
efficacy and error then reboot the system. If the
2) Eliminate strong
ERR1101239 ERR Incorrect channel no. electromagnetic interference,
then reboot the system. If the
Main control unit command 2) Eliminate strong
ERR1101244 ERR electromagnetic interference,
efficacy and error
then reboot the system. If the
Perform a malfunction recovery
Main control unit control command. If the problem continues to
ERR1101252 ERR
error reoccur, please contact Manufacturer's
1) Turn on the system lamp
Optical data returned by 2) Please contact the
WAR2100001 WAR
all channels is zero. Manufacturer technical support
department.
1) Adjust the AD value of
each channel to within the
The channel background standard range;
WAR2100002 WAR value is equal to the set 2) Replace the lamp;
maximum 3) Please contact the
department.
WAR2100003 WAR value is lower than the 2) Replace the lamp;
alarm value 3) Please contact the
department.
211

WAR2100004 WAR value is lower than the 2) Replace the lamp;
warning value 3) Please contact the
department.
The remaining reagent
volume of Item [{0}] is {1}
WAR3200602 WAR Add reagent.
insufficient. disk
No.: {2}, Cuvette No.: {3}
The remaining
measurements [{1}] of
chemistry [[0}] are less
WAR3200603 WAR Add reagent.
than warning limits
[{2}].disk No.: {3}, Cuvette
No.: {4}
Retest after diluting the sample;

Prozone check point P of
WAR3200606 WAR Check whether or not the limit
chemistry [{0}] is abnormal
settings are suitable.
The light source

WAR3200607 WAR Replace the lamp.
intensity is very low
The the light source

WAR3200608 WAR Replace the lamp.
intensity is low
There was an error in the

Channel {0} configuration
photoelectric module configuration
WAR3200609 WAR is not found in dark
file. Please contact Manufacturer
current configuration
technical support.
Dark current value [{1}] of There was a malfunction in the

WAR3200610 WAR channel {0} exceeds photoelectric module. Please contact
alarm value [{2}] Manufacturer technical support.
Deionized water level is

WAR3200611 WAR low. disk No.: {0}, Cuvette Add deionized water
No.: {1}
212
Appendix A
Appendix A
A.1. Common Terms
A.1.1. AD Value
The photocurrent generated by light reaching the sensor. The current passes through a fixed
resistor and, after amplification, is converted into a photoelectric voltage (analog signal).
This voltage is then subject to an AD conversion (digital-analog conversion) to create a
value of corresponding size (the size is correlated with the bit value of the selected AD). This
value is the AD value.
A.1.2. Dark Current

The value output by the electrical circuit when the light source is not on (i.e., when there is no
signal light). Expressed as an AD value. Dark current is effectively equivalent to the background
current of the circuit and this value must be deducted when calculating absorbance.
A.1.3. Water Blank

The absorbance when purified water is loaded into the cuvette being examined. Since
absorbance values are relative - that is, they are based on an arbitrary absorbance base
value - the absorbance of a water blank is defined as 0. That is, all other absorbance values
must have the absorbance value of the reaction cuvette containing a water blank subtracted
from their initial values. In analyzers which has not the auto wash station, the water blank
value is the cuvette blank value (The absorbance value of an empty cuvette).
A.1.4. Optical Metering Point

This value is typically shown as a specific cyclical value when performing a photoelectric
test on a reaction solution. There are strict and fixed relationships between each optical
metering point; Each reaction features 40 optical metering points, and in high-speed mode
the time intervals between two adjacent optical metering points is 24 seconds; In standard
mode, the time interval between two adjacent optical metering points is 36 seconds.
A.1.5. Absorbance
The value obtained by taking the negative common logarithm (base 10) of the transmitted
light intensity divided by the incident light intensity. The incident light intensity is the AD
value of a reaction cuvette filled with distilled water. The absorbance value shown is the
computed absorbance × 20000.
A.1.6. Reaction Curve

The series of points plotted on a plane where optical metering points are plotted on the
horizontal axis and absorbance is plotted on the vertical axis. In high-speed mode, a single
cycle lasts 24 seconds; In standard mode, a single cycle lasts 36 seconds.
213
Appendix A
Absorbance
Add S Add R2
Add R1
1 9 10 18 19 Optical
Metering Point
A.1.7. Reactivity
The change or rate of change following the reaction or during the course of the reaction.
A.1.8. Calibration
Also referred to as alignment. The reaction amplitude of one or more calibrators with known
concentration (or activity) is measured and, based on the calibration method selected by the
user (linear or nonlinear), a best-fit curve is fit to the data set (concentration, reactivity) and a
mathematical expression for this curve is computed. By using this curve and determining the
reactivity of a sample of unknown concentration (or activity), it is possible to calculate the
concentration (or activity) of the sample.
A.1.9. Calibration Curve

Points are arranged on a coordinate plane with concentration (or activity) displayed on the
horizontal axis and reactivity displayed on the vertical axis. A fit for the curve is then
computed using an optimal mathematical formula.
A.1.10. Calibration Parameter

Refers to all terms present in the relational expression governing calibration with the
exception of concentration and reactivity.
214
Appendix A
A.2. Technical Parameters
Para. Name Parameter Values

Random optional discrete type, emergency insertion,
Instrument Type
all reagents permitted
Central Wavelength
±2nm
Deviation
Half-Wave Width ≤12nm
Stray Light ≥ 4.5 (in absorbance)

Test Speed 150 tests/hour (high speed mode); 100 tests/hour (standard mode);
Analysis Principle colorimetry, turbidimetry
Endpoint method, two-point method, kinetic method, support for
Test Method single and double reagents, turbidimetric immunoassay method and
linear and nonlinear calibration methods
Linear (single-point, two- and multi-point), logit-log4p, logit-log5p,
Cal Method
spline, exponential functions, etc., ≥ 6 types
Number of Items for
40 single reagents or 20 double reagents; reagents unrestricted,
which Simultaneous
supports domestic and imported reagents
Analysis is Possible
Maximum Reaction
18.6 min for single reagent test, 13.2min for dual reagent test
Time
40 sample positions, compatible with variety of differently sized
Sample Disk
miniature sample vials, original blood collection tubes, plastic tubes, etc.
1 probe which includes a liquid level sensor, volume tracking,
Sample Probe three-dimensional anti-collision protection and automatic cleaning
functionality
Sample Vol 2 ~ 50 ul in 0.1ul increments
1 disk containing 40 reagent positions, 20 on the inner ring and 20 on
R.Crsl
the outer ring
probe is shared with the Sample probe which includes a liquid level
Reagent Probe sensor, volume tracking, three-dimensional anti-collision protection
and automatic cleaning functionality
Reagent Volume R1：150~450μL，R2:10~300μL，1μL in 1μL increments
Reagent
4 - 12 ℃, 24-hour continuous refrigeration
Refrigeration
Mixer Independent mixer
Minimum reaction
160 μL
volume
215
Appendix A
Cuvettes 50 semi-permanent Ultraviolet transmission rigid cuvettes
Cuvette wash 6-step auto cuvette washing (For analyzer with auto wash function)
Carryover
≤ 0.005%
Contamination Rate
Solid thermostat, reaction disk temperature maintained at

Thermostat System
37 ± 0.3 °C, free routine maintenance
Light Source Halogen lamp, 12V / 20W, minimal current with high stability
Wavelengths 8 wavelengths: 340, 405, 450, 510, 546, 578, 630 and 670 nm
Spectrophotometry
Post-sample splitting, maintenance-free
Method
Detector Fully enclosed photodiode array, maintenance-free for life

Linear range of
0～3.5A
absorbance
Resolution 0.0001Abs
A.3. Power Requirements
Power Supply
AC 100 - 240V, 50/60Hz ± 1 Hz
Requirements
Input Power (VA) 350
A.4. Operating Ambient Temperature and Humidity

Requirements
Environmental Temperature: 10 - 30 °C;

Work Environment
Relative Humidity Range: 30% - 85%
A.5. Computer and Printer Configuration
CPU of 2.0 GHz or greater, more than 4.0 GB of RAM, Hard disk
Computer
more than 40G free space, preloaded with the Windows 7 , win 10
Configuration
operating system; Display resolution should be above 1280*768
Display Resolution;
Printer Supports laser, inkjet and dot matrix printers
216
Appendix A
A.6. Communication Interface
Communication Interface for Biochemical

RS-232 serial interface
Analyzer Host Machine and Computer
A.7. Dimensions and Weight
Bare Dimensions (mm, length*depth*height) 750*470*580
Net Weight (kg) （without auto wash function ） 45
Net Weight (kg) （with auto wash function ） 50
A.8. Options
Options Barcode module, touch screen module.
A.9. Other
Overall water consumption <2L/h
Operating noise (dB) < 65
A.10. Transport and Storage Requirements
Temperature 0°C - 40°C
Humidity Relative humidity of 30% - 90%.
A.11. Safety Classifications
Electric Shock Prevention Class Class I externally-powered equipment
Overvoltage Class Class II
Pollution Class Class 2
217
Appendix A
A.12. After-Sales Service
After-sales service is provided by manufacturer.
A.13. Warranty Service
The entire machine is covered by a comprehensive warranty for a full year from the date of
installation. However, damage occurring under the following conditions shall not be covered
by this warranty:
1) Environment in which the machine is used does not meet the requirements
indicated in the manual;
2) Damage caused by use of an unspecified power supply or any other abnormality in

the power supply;
3) Artificial damage;
4) Damage caused as a result of maintenance performed by personnel not authorized

by Manufacturer;
5) Other damage caused by uncontrollable natural factors such as earthquakes, fires

or war;
In the event you have any inquiries or questions while using the instrument, you can always
call our customer support call center.
A.14. EMC Description
Attention :
 This equipment complies with the emission and immunity requirements of the IEC
61326-2-6:2005
 Users have responsibility to guarantee the EMC environment so that machine can
work normally
 It’s recommend to evaluate the EMC environment before use machine
Cautions :
 The analyzer is designed and tested according to IEC/CISPR 11:2010. The device
may cause radio interference in home environment , in which case , you may need to
take measures to mitigate the interference.
 It’s forbidden to use machine near strong radiation source which may disturb
the use of machine
218
Appendix A
Table 1：
EMC emission
Applied test Performance Criteria
IEC/CISPR 11:2010
Conducted Emission
1Mode-Class A
IEC/CISPR 11:2010
Radiated Emission
IEC 61000-3-2: 2009

n.a.
Harmonic Currents Emission
IEC 61000-33: 2005

n.a.
Voltage Fluctuations/Flicker Emission
Table 2：
EMC immunity
Test Performance
Test item Test Requirment
Standard Criteria
Contact discharge：±2kV、±4kV
IEC
ESD Immunity 61000-4-2: B
Air discharge：±2kV、±4kV、
2008
±8kV
Radiated IEC
3V/m，80MHz～2.0GHz，
Electromagnetic 61000-4-3: A
80%AM
Filed Immunity 2010
IEC
EFT Immunity 61000-4-4: Power cable：±1kV(5/50ns,5kHz) B
2012
219
Appendix A
IEC L-PE , N-PE：±2kV

Surge 61000-4-5: B
2005 L-N：±1kV
IEC
Power cable：3V，150kHz～
Conducted Immunity 61000-4-6: A
80MHz，80%AM
2013
IEC
Power Frequency
61000-4-8: 3A/m，50/60Hz A
magnetic field
2001
1 cycle , 0%； B
Voltage Dips and IEC 5/6 cycle, 40%； C

interruptions 61000-4-11:
Immunity 2004 25/30 cycle , 70%； C
250/300 cycle, 5% C
Definition：
A. The performance is normal in the limit during test
B. The performance or function decline or lose but it can automatically recover during test.
C. The performance or function decline or lose that operator need to intervene or system reset
during test
A.15. Removal of equipment from use for repair or

disposal
1) All test samples, such as calibrator and control, are infectious . Please use cotton dipped
in 75% alcohol to clean if there are sample spilled on the instrument surface , otherwise it
may cause biohazard like infection by touching. If there is plenty of liquid spilled and enter
the internal machine, please stop using and disconnect the power cable. Contact with
manufacturer or distributor.
2) The instrument surface should be disinfected completely to minimize the biohazard
when the instrument is carried , being changing location , delivery , maintenance , etc.
Please stop using machine when there is collision , falling on instrument no matter there is
obvious damage on the surface or inside . And please contact with manufacturer or
220
Appendix A
distributor.
3) Please contact with manufacturer or distributor when there is problem of machine.
4) It’s suggested to stop using machine or use it after manufacturer’s full inspection and
maintenance of instrument when it reaches its life (5 years )
5) This device may only be operated and used by authorized personnel who have
undergone training provided by manufacturer or authorized representatives of manufacturer.
A.16. Toxic or Hazardous Substances and Elements
Toxic or Hazardous Substances and Elements

Item
Pb Hg Cd Cr(VI) PBB PBDE
Host shell ○ ○ ○ ○ ○ ○
Host PCBA ×(1 ○ ○ ○ ○ ○

)
Host sheet metal ○ ○ ○ ○ ○ ○
parts
Host machine
○ ○ ○ ○ ○ ○
Host processing part
Host plastic parts ○ ○ ○ ○ ○ ○
Host hardware ○ ○ ○ ○ ○ ○
Host connecting
○ ○ ○ ○ ○ ○
cable
Host hydraulic ○ ○ ○ ○ ○ ○
parts
Label ○ ○ ○ ○ ○ ○
Cable ○ ○ ○ ○ ○ ○
Accessory Maintenance tool ○ ○ ○ ○ ○ ○
Inlet/Outlet tube ○ ○ ○ ○ ○ ○
Tank ○ ○ ○ ○ ○ ○
Packaging Packing material ○ ○ ○ ○ ○ ○
○：Indicates that this toxic or hazardous substance contained in all the homogeneous
materials for this part is below the limit requirement in Rohs 2.0.
×：Indicates that this toxic or hazardous substance contained in at least one homogeneous
materials for this part is above the limit requirement in Rohs 2.0.
(1)：Some part of circuit board involves Pb. During process , Leaded soldered is used.
221
Appendix A
Note：The place which marked ―×‖ is because currently there is no replaceable technology or
unit. There is no leak or mutation in 5 years for normal use of machine. It also won’t cause
pollution to the environment or harm to people and property.
P/N: CA15.10.10000012 A.0 Version: A/2
222

Auto Chemistry Analyzer: Operation Manual

Uploaded by

Auto Chemistry Analyzer: Operation Manual

Uploaded by

Auto Chemistry Analyzer

1) Installation, use, operation, maintenance and repair are performed by personnel

2) Any associated electrical equipment complies with national standards;

Product Name: Auto Chemistry Analyzer

Safety Classifications: Class II Overvoltage, Pollution Grade 2.

Management Classification: This device is classified as a Biochemical Analysis System

Manufacturing Date: see the label on the back of device

Life Span : 5 years

Revising Date of this manual: June 19th, 2019

The following is a list of symbols used in this manual.

Warning! May cause damage to the analyzer or affect

May result in biological contamination.

May result in electric shock.

May cause corrosive damage.

High temperatures which may cause injury.

Glare which may cause eye injury.

May result in bodily injury.

Flammable substance which may result in a fire.

Screen Printing and Labels

Device Serial Number

Protective Conductor Terminal

The product is an in vitro diagnostic device

The manufacturer’s catalogue number to

Authorized representative in the European

CE Mark （CE certificated）

OFF Power Off

Serial Port Communication Port

Waste Liquid Outlet Waste Liquid Outlet

Purified Water Inlet Purified Water Inlet

Fragile , handle with care

Keep away from sunlight

Atmospheric pressure range for safely

The analyzer, after being scrapped, should not

1. Safety and Precautions .................................................................. 7

2.3.1. Environmental Requirements ........................................................................ 14

3. Structure and Functions ............................................................. 29

4. Detailed Operating Procedure .................................................... 42

4.4. Online Status ............................................................................................................ 60

5. Simplified Operating Procedures .................................................. 131

5.1.8. Modify a Calibrator ........................................................................................ 133

6. Analysis Principles and Computational Methods ...................... 145

6.6. QC ............................................................................................................................ 161

7. Care and Maintenance .............................................................. 170

8. Alarm Information and Processing .......................................... 190

8.1. Overview ................................................................................................................. 190

Appendix A .......................................................................................... 213

1. Safety and Precautions

1.1.4. High Temperature

1.1.5. Electric Shock

2) Spillage of liquid on the device's countertop should be avoided and in

3) The internal parts of computers, printers and other components are

1.1.6. Bodily Injury

1.1.7. Biological Contamination

2) All waste liquid should be considered contagious and protective

1.2.1. Scope of Use:

2) When making a clinical diagnosis using test results, a comprehensive

1.2.2. Device Operator

1.2.3. Operating Environment

2) If the operating environment of the analyzer needs to be modified,

1.2.4. Electromagnetic Interference

2) The analyzer will emit electromagnetic radiation during operation.

1.2.5. Improper Grounding

2) Ground impedance must be less than 0.1Ω; poor grounding can

1.2.6. Loss of Label Stickers

1.2.7. Liquid Leakage

1.2.8. Probe Obstruction

1.2.9. Water Quality

1.2.10. System Use

3) When using the system on a regular basis, it is recommended that

4) During analysis, do not open the reaction disk cover.

5) Before performing an analysis, close the reaction disk cover and

6) During the analysis process, make sure there are no obstructions in

8) Do not install any hardware or software onto the computer comprising

1.2.11. System Maintenance

2) After replacing major system components, such as the light

3) When using the instrument in South Asian countries which feature