GS300 User Manual PDF

Auto Chemistry Analyzer
Operation Manual
Introduction
We would like to sincerely thank you for choosing to purchase this 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.
i
Manual Overview
This manual is focused on helping users to understand several aspects of the SERVICE
AGENT 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
Screen Printing and Labels
The screen printings and labels listed below are used in this manual.
Labels Meaning
Product Serial Number
Protective Conductor Terminal
Manufacturing Date
Manufacturer
The product is an in vitro diagnostic device
～ AC
Power On
Power Off
CHEMISTRY
Biochemical Analyzer
ANALYZER
ON Power On
OFF Power Off
Serial Port Communication Port
Waste Liquid Outlet Waste Liquid Outlet
Pure Water Inlet Pure Water Inlet
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.
1
Contents
Introduction .............................................................................................. i
Manual Overview ................................................................................................................... ii
Symbols .................................................................................................................................. ii
Screen Printing and Labels .................................................................................................. 1
Figures .................................................................................................................................... 1
1. Safety and Precautions .................................................................. 11

1.1. Safety ........................................................................................................................ 12
1.1.1. Glare .................................................................................................................. 12
1.1.2. Combustibles ................................................................................................... 12
1.1.3. Explosion .......................................................................................................... 12
1.1.4. High Temperature ............................................................................................ 12
1.1.5. Electric Shock .................................................................................................. 12
1.1.6. Bodily Injury ...................................................................................................... 13
1.1.7. Biological Contamination ................................................................................ 13
1.1.8. Corrosion .......................................................................................................... 13
1.2. Precautions .............................................................................................................. 14
1.2.1. Scope of Use: .................................................................................................. 14
1.2.2. Device Operator .............................................................................................. 14
1.2.3. Operating Environment................................................................................... 14
1.2.4. Electromagnetic Interference......................................................................... 14
1.2.5. Improper Grounding ........................................................................................ 14
1.2.6. Loss of Label Stickers ..................................................................................... 15
1.2.7. Liquid Leakage ................................................................................................ 15
1.2.8. Probe Obstruction ........................................................................................... 15
1.2.9. Water Quality ................................................................................................... 15
1.2.10. System Use ...................................................................................................... 15
1.2.11. System Maintenance ...................................................................................... 16
1.2.12. Samples ............................................................................................................ 17
1.2.13. Reagents, Calibrators and Control Fluids .................................................... 17
1.2.14. Cuvettes ............................................................................................................ 18
1.2.15. Analysis Parameters ....................................................................................... 18
1.2.16. Data Backup ..................................................................................................... 18
1.2.17. Disposing of the Instrument ........................................................................... 18
2. Installation .................................................................................... 19
2.1. Installation................................................................................................................. 20
2.2. Damage Inspections ............................................................................................... 20
2.3. Installation Requirements ....................................................................................... 21
2.3.1. Environmental Requirements ........................................................................ 21
2.3.1.1. Power Supply ............................................................................... 21
2.3.1.2. Site and Space ............................................................................. 21
2.3.1.3 Temperature, Humidity and Atmospheric Pressure ................ 21
2
2.3.2. Computer Requirements ................................................................................ 21
2.4. Water Supply and Drainage Requirements ......................................................... 22
2.4.1. Water Supply Requirements .......................................................................... 22
2.4.2 Drainage Requirements .................................................................................. 22
2.5. Connecting Fluid Lines ........................................................................................... 23
2.6. Installing or Removing Sample /Reagent Disk .................................................... 25
2.7. Loading and Unloading Sample Test Tubes ........................................................ 26
2.8. Loading and Unloading Reagent Bottles ............................................................. 26
2.9. Installing the System Software .............................................................................. 27
3. Structure and Functions ............................................................. 32

3.1. Composition of the Analysis Unit ........................................................................... 33
3.1.1. Overall Structure .............................................................................................. 33
3.1.2. Top Structure.................................................................................................... 34
3.1.3. Rear Structure .................................................................................................. 35
3.1.4. Structure of the Left Side of the Analysis Unit ............................................. 36
3.1.5 Structure of the Right Side of the Analysis Unit .......................................... 37
3.2. Function Module ...................................................................................................... 38
3.2.1. Sample Probe Aspiration Volume ................................................................. 38
3.2.2. Stirring Mechanism .......................................................................................... 39
3.2.3. Reaction Disk ................................................................................................... 40
3.2.4. Thermostatic Groove....................................................................................... 41
3.2.5. Reagent / Sample Disk ................................................................................... 42
3.2.6. Reagent Refrigerator....................................................................................... 43
3.2.7. Enhanced Wash Solution Position ................................................................ 44
3.2.8. Optical System ................................................................................................. 44
4. Detailed Operating Procedure .................................................... 46

4.1. Operating Software.................................................................................................. 50
4.1.1. Basic Procedure for Logging In ..................................................................... 50
4.2. Interface Layout ....................................................................................................... 51
4.2.1.
Function Menu Area ........................................................................................ 51
4.2.2.
Submenu Function Key Area ......................................................................... 52
4.2.3.
Shortcut Button Area ....................................................................................... 52
4.2.3.1. Start ................................................................................................ 52
4.2.3.2. Suspension of Pipetting .............................................................. 53
4.2.3.3. Stop ................................................................................................ 53
4.2.3.4. Shut Down ..................................................................................... 54
4.2.3.5. Emergency Shutdown ................................................................. 54
4.2.3.6. Routine Maintenance................................................................... 54
4.2.3.7. Lock System ................................................................................. 55
4.2.4. Function Display Area ..................................................................................... 55
4.2.5. Status Bar ......................................................................................................... 55
4.2.6. Message Alert Area ......................................................................................... 55
4.3. Test Request............................................................................................................. 57
4.3.1. Sample Request .............................................................................................. 57
4.3.1.1. Introduction of Basic Parameters............................................... 57
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4.3.1.2. Details ............................................................................................ 58
4.3.1.3. Introduction to Application Features.......................................... 61
4.3.1.4. Sample Program .......................................................................... 62
4.3.1.5. Repeat Test ................................................................................... 62
4.3.1.6. Sample Blank ............................................................................... 62
4.3.1.7. Dilution Test .................................................................................. 62
4.3.1.8. Auto Dilution Rerun ..................................................................... 63
4.3.2. QC Request...................................................................................................... 63
4.3.2.1. Introduction of Basic Parameters .............................................. 63
4.3.2.3. QC Request .................................................................................. 64
4.3.3. Calibration Request ........................................................................................ 65
4.3.3.3. Calibration Request ..................................................................... 66
4.4. Online Status ............................................................................................................ 67
4.4.1.
Sample Disk Status ......................................................................................... 67
4.4.1.1. Status Explanation ....................................................................... 68
4.4.2. Reagent Disk Status ....................................................................................... 70
4.4.2.4. Reagent Position Settings .......................................................... 72
4.4.2.5. Reagents Scan ............................................................................. 73
4.4.2.6. Inventory........................................................................................ 73
4.4.2.7. Reset Volume ............................................................................... 74
4.4.2.8. Release Positions ........................................................................ 75
4.4.2.9. Reagent Status ............................................................................. 75
4.4.3. Reaction Disk Status ....................................................................................... 76
4.4.4. Test List ............................................................................................................. 78
4.4.4.1. Explanation of Status and Functions......................................... 79
4.5. Query Results .......................................................................................................... 80
4.5.1. Sample Result Query...................................................................................... 80
4.5.1.2. Search Conditions ....................................................................... 81
4.5.1.3. Delete Sample .............................................................................. 81
4.5.1.4. Delete Item.................................................................................... 81
4.5.1.5. Rerun ............................................................................................. 82
4.5.1.6. Recalculate ................................................................................... 82
4.5.1.7. Preview / Print .............................................................................. 82
4.5.1.8. Send to LIS ................................................................................... 82
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4.5.1.9. Reaction Curve ............................................................................. 82
4.5.1.10. Modify Result ................................................................................ 82
4.5.1.11. View by Item.................................................................................. 82
4.5.2. Quality Control Result Query ......................................................................... 83
4.5.2.2. Introduction to Application Features .......................................... 84
4.5.2.3. Quality Control Result Query...................................................... 85
4.5.3. Calibration Result Query ................................................................................ 86
4.5.3.3. Blank Correction ........................................................................... 87
4.5.3.4. Copy Cal ........................................................................................ 87
4.5.3.5. Delete ............................................................................................. 89
4.5.3.6. Send to LIS ................................................................................... 89
4.5.3.7. Calibration Curve ......................................................................... 89
4.5.4. Reagent Blank Query...................................................................................... 90
4.5.4.1. Basic Operation: ........................................................................... 91
4.6. Para. Setup ............................................................................................................... 91
4.6.1.
Routine Chemistry ........................................................................................... 91
4.6.1.1. Basic Parameters ......................................................................... 92
4.6.1.2. Monitoring Parameters ................................................................ 97
4.6.1.3. QC Parameters............................................................................. 99
4.6.2. Special Calculations ...................................................................................... 100
4.6.2.1. Explanation of Basic Parameters............................................. 101
4.6.2.2. Basic Operations ........................................................................ 102
4.6.3. Panels.............................................................................................................. 103
4.6.4. Carryover ........................................................................................................ 104
4.6.5. Calibrator Setup ............................................................................................. 106
4.6.6. QC Setup ........................................................................................................ 107
4.6.7. ISE Setup ........................................................................................................ 109
4.6.7.1. System Setup ............................................................................. 110
4.6.7.2. ISE Parameters .......................................................................... 111
4.7. Statistical Reports .................................................................................................. 116
4.7.1. Test Statistics.................................................................................................. 116
4.7.2. Workload Statistics ........................................................................................ 117
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4.7.2.1. Explanation of Basic Parameters ............................................ 118
4.7.2.2. Basic Operations........................................................................ 118
4.7.3. Charge Statistics............................................................................................ 119
4.7.4. Result Statistics ............................................................................................. 120
4.8. Function Settings ................................................................................................... 122
4.8.1.
System Setup ................................................................................................. 122
4.8.1.1. Function Enable ......................................................................... 122
4.8.1.2. Multi-Pos. Rgt Aspirating Rules ............................................... 125
4.8.2. Hospital Setup................................................................................................ 125
4.8.2.1. Hospital Information................................................................... 126
4.8.2.2. Physician Information ................................................................ 127
4.8.3. User Management ......................................................................................... 128
4.8.3.1. Role Management ..................................................................... 128
4.8.3.2. User Setup .................................................................................. 130
4.8.4. Print Setup ...................................................................................................... 131
4.8.4.1. Template Setup .......................................................................... 132
4.8.4.2. Print Order .................................................................................. 134
4.8.4.3. Print List ...................................................................................... 135
4.8.5. Barcode Setup ............................................................................................... 136
4.9. System Maintenance ............................................................................................ 139
4.9.1. Routine Maintenance .................................................................................... 139
4.9.1.1. Routine Maintenance Commands ........................................... 139
4.9.1.2. ISE Calibration ........................................................................... 140
4.9.1.3. ISE Maintenance........................................................................ 141
4.9.2. Log Management .......................................................................................... 146
4.9.3. Temperature Curve ....................................................................................... 148
4.9.4. Enter Maintenance ........................................................................................ 149
4.9.5. Three-Probe Parameter Configuration ....................................................... 149
4.9.5.1. Sample Probe Parameter Configuration ................................ 149
4.9.5.2. Stirring Rod Parameter Configuration ..................................... 150
4.9.5.3. Sample Probe Wall Pump Parameters Configuration .......... 150
4.9.5.4. Mixer Wash Pump Parameters Configuration ....................... 151
4.9.5.5. Introduction to Parameters and Features............................... 151
5. Simplified Operating Procedures ............................................. 153

5.1. Operational Procedures for Basic Functions..................................................... 155
5.1.1. Add Item.......................................................................................................... 155
5.1.2. Change Item Parameters ............................................................................. 155
5.1.3. Delete Item ..................................................................................................... 155
6
5.1.4. Add Control Solution ..................................................................................... 156
5.1.5. Modify Control Solution................................................................................. 157
5.1.6. Delete Quality Control Solution ................................................................... 157
5.1.7. Add New Calibrator ....................................................................................... 157
5.1.8. Modify a Calibrator ........................................................................................ 157
5.1.9. Delete a Calibrator......................................................................................... 158
5.1.10.Set Reagent Positions .................................................................................. 158
5.1.11.Modify Reagent Information ......................................................................... 158
5.1.12.Release Reagent Positions .......................................................................... 159
5.1.13.Reagent Blank Test Procedure .................................................................... 159
5.1.13.1. Request ....................................................................................... 159
5.1.13.2 Testing.......................................................................................... 159
5.1.14. Calibration Test Procedure ........................................................................... 160
5.1.14.1. Request ....................................................................................... 160
5.1.14.2 Testing.......................................................................................... 160
5.1.15. Quality Control Test Procedure.................................................................... 161
5.1.15.1. Request ....................................................................................... 161
5.1.15.2 Testing.......................................................................................... 161
5.1.16 Sample Testing Procedure ........................................................................... 161
5.1.16.1. Request ....................................................................................... 161
5.1.16.2 Testing.......................................................................................... 162
5.2. Operating Procedures for Opening a New Item ................................................ 163
5.3 Routine Operational Procedures ......................................................................... 164
5.3.1. Pre-Startup Check ......................................................................................... 164
5.3.2. Powering On the System .............................................................................. 165
5.3.3. Order of Operational Procedures ................................................................ 165
5.3.4. System Setup ................................................................................................. 166
5.3.5. Item Parameter Settings ............................................................................... 166
5.3.6. Reagent Position Settings ............................................................................ 166
5.3.7. Setup ............................................................................................................... 166
5.3.8. QC Settings .................................................................................................... 166
5.3.9. Test Request .................................................................................................. 166
5.3.10. Test Preparation ............................................................................................. 167
5.3.11. Start.................................................................................................................. 167
5.3.12. Test Result Query .......................................................................................... 168
5.3.12.1. Calibration Result Query ........................................................... 168
5.3.12.2. Quality Control Result Query.................................................... 168
5.3.12.3. Sample Results Query .............................................................. 168
5.3.12.4 Reagent Blank Query Results .................................................. 169
5.3.13. Adding Tests ................................................................................................... 169
5.3.14. Shutdown ........................................................................................................ 169
5.3.15. Powering Off the System .............................................................................. 170
5.3.16 Post-Shutdown Inspection............................................................................ 170
6. Analysis Principles and Computational Methods................... 171

6.1. Analysis Principle................................................................................................... 172
7
6.2. Analysis Procedure ............................................................................................... 172
6.2.1. Actions Performed by the Device................................................................ 172
6.2.2. Operating Position ......................................................................................... 173
6.2.3. Testing Process ............................................................................................. 173
6.2.4. Optical Metering Point .................................................................................. 174
6.3. Analysis Methods and Reactivity Calculations ................................................. 175
6.3.1.
Absorbance Calculation ............................................................................... 175
6.3.2.
Endpoint Method ........................................................................................... 176
6.3.2.1. Single Reagent Endpoint Method............................................ 176
6.3.2.2. Double Reagent Endpoint Method .......................................... 179
6.3.3. Two-Point Method (Fixed-Time Method) ................................................... 181
6.3.3.1. Single Reagent Two-Point Method.......................................... 181
6.3.3.2. Double Reagent Two-Point Method ........................................ 182
6.3.4. Kinetic Method ............................................................................................... 183
6.3.4.1. Single Reagent Kinetic Method ............................................... 183
6.3.4.2 Double Reagent Kinetic Method .............................................. 184
6.4. Calibration .............................................................................................................. 186
6.4.1. Calibration Types ........................................................................................... 186
6.4.2 Calculation of Calibration Parameters ............................................................ 186
6.5. Results Calculation ............................................................................................... 187
6.6. QC............................................................................................................................ 188
6.6.1. Quality Control Rules and Determination .................................................. 188
6.6.1.1. Westgard Multi-Rule .................................................................. 188
6.6.1.2. Cumulative Sum ......................................................................... 189
6.6.1.3 Twin Plot ...................................................................................... 189
6.6.2. Quality Control Query ................................................................................... 189
6.6.3 QC Charting ................................................................................................... 189
6.7 Other Related Calculations .................................................................................. 191
6.7.1. Calibration Curve-Related Calculations ..................................................... 191
6.7.2. Substrate Depletion Determination............................................................. 193
6.7.3. Linearity Test .................................................................................................. 193
6.7.4. Prozone Check .............................................................................................. 194
6.7.5. Determination of Lamp State ....................................................................... 196
6.7.6 Examination of Cuvette Cleanliness........................................................... 196
7. Care and Maintenance ............................................................... 197

7.1. Preparation of Tools .............................................................................................. 198
7.2. Daily Maintenance ................................................................................................. 198
7.2.1.
Wiping Down the Analyzer Countertop ...................................................... 198
7.2.2.
Cleaning the Sample Probe / Stirring Rod................................................. 199
7.2.2.1. Cleaning the Sample Probe ..................................................... 199
7.2.2.2 Cleaning the Stirring Rod ......................................................... 200
7.2.3. Inspecting the Reagent / Sample Syringe ................................................. 200
7.2.4. Inspecting the Purified Water Bucket ......................................................... 202
7.2.5 Inspecting the Waste Liquid Container / Tubing ....................................... 203
7.3. Weekly Maintenance............................................................................................. 204
8
7.3.1. Cleaning the Primary Purified Water Filter ................................................ 204
7.3.2. Cleaning the Waste Liquid Container ......................................................... 205
7.3.4 Cleaning the Reagent / Sample Disk Refrigeration Unit....................... 205
7.4. Monthly Maintenance ............................................................................................ 206
7.4.1. Cleaning the Cleaning Pool.......................................................................... 206
7.4.2. Cleaning the Thermostatic Groove of the Reaction Disk ........................ 207
7.4.3. Wiping the Driving Rod ................................................................................. 208
7.4.4 Cleaning the Dust Filter ................................................................................ 208
7.5. Semi-Annual Maintenance ................................................................................... 208
7.5.1. Replacing the Primary Stage Filter ............................................................. 208
7.5.2 Replacing the Second Stage Filter ............................................................. 209
7.6. Unscheduled Maintenance ................................................................................... 209
7.6.1. Unblocking the Sample and Reagent Probes ........................................... 209
7.6.2. Replacing the Sample Probe ....................................................................... 210
7.6.3. Replacing the Stirring Rod ........................................................................... 212
7.6.4. Replacing the Lamp ...................................................................................... 213
7.7. Replaceable Device List ....................................................................................... 215
7.7.1. The following is a list of items that can be replaced by the user ......... 215
7.7.2 List of Parts that Require a Maintenance Engineer for Replacement ... 215
7.8 Maintenance Log ................................................................................................... 216
8. Alarm Information and Processing .......................................... 219

8.1. Overview ................................................................................................................. 220
8.2 Alarm Information Inquiry ..................................................................................... 220
8.2.1. Error Code Definition..................................................................................... 220
8.2.1.1. Error Level Code Definitions .................................................... 220
8.2.1.2. Host Machine Code Module Definitions ................................. 221
8.2.1.3 Slave Machine Unit Code Definitions...................................... 221
8.2.2 Instrument Runtime Error Table................................................................... 221
Appendix A .......................................................................................... 249

A.1. Common Terms ...................................................................................................... 250
A.1.1. AD Value ......................................................................................................... 250
A.1.2. Dark Current ................................................................................................... 250
A.1.3. Water Blank .................................................................................................... 250
A.1.4. Optical Metering Point................................................................................... 250
A.1.5. Absorbance .................................................................................................... 250
A.1.6. Reaction Curve .............................................................................................. 250
A.1.7. Reactivity ........................................................................................................ 251
A.1.8. Calibration ....................................................................................................... 251
A.1.9. Calibration Curve ........................................................................................... 251
A.1.10 Calibration Parameter ................................................................................... 251
A.2. Technical Parameters............................................................................................ 252
A.3. Power Requirements............................................................................................. 253
A.4. Operating Ambient Temperature and Humidity Requirements ....................... 253
A.5. Computer and Printer Configuration ................................................................... 253
A.6. Communication Interface...................................................................................... 254
9
A.7. Dimensions and Weight........................................................................................ 254
A.8. Options .................................................................................................................... 254
A.9. Other........................................................................................................................ 254
A.10. Transport and Storage Requirements ................................................................ 254
A.11. Safety Classifications ............................................................................................ 255
A.12. After-Sales Service ............................................................................................... 255
A.13. Warranty Service ................................................................................................... 255
10
1. Safety and Precautions
1.1. Safety............................................................................................ 12
1.1.1. Glare........................................................................................................ 12
1.1.2. Combustibles .......................................................................................... 12
1.1.3. Explosion ................................................................................................. 12
1.1.4. High Temperature.................................................................................... 12
1.1.5. Electric Shock ......................................................................................... 12
1.1.6. Bodily Injury............................................................................................. 13
1.1.7. Biological Contamination ........................................................................ 13
1.1.8. Corrosion ................................................................................................. 13
1.2. Precautions ......................................................................................................... 14
1.2.1. Scope of Use: ........................................................................................ 14
1.2.2. Device Operator ...................................................................................... 14
1.2.3. Operating Environment ........................................................................... 14
1.2.4. Electromagnetic Interference .................................................................. 14
1.2.5. Improper Grounding ................................................................................ 14
1.2.6. Loss of Label Stickers ............................................................................. 15
1.2.7. Liquid Leakage ........................................................................................ 15
1.2.8. probe Obstruction.................................................................................... 15
1.2.9. Water Quality........................................................................................... 15
1.2.10. System Use ............................................................................................. 15
1.2.11. System maintenance .............................................................................. 16
1.2.12. Samples .................................................................................................. 17
1.2.13. Reagents, Calibrators and Control Fluids ............................................... 17
1.2.14. Cuvettes .................................................................................................. 18
1.2.15. Analysis Parameters ............................................................................... 18
1.2.16. Data Backup ............................................................................................ 18
1.2.17. Disposing of the Instrument .................................................................... 18
11
The following are warning symbols used in conjunction with the 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 print head or metal objects around the print head
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 pressure, so please do not touch the interior of these
devices.
12
1.1.6. Bodily Injury
1) Please be careful with the sharp elements of the analyzer, such as
reagent probe tips, sample probe tips, stirring rods, 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, stirring rod,
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, stirring rods, 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.
13
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 authorized representatives.
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 authorized 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 10 mΩ; poor grounding can

cause instability in measurement results and electrical leakage from
the enclosure, producing a shock hazard.
14
1.2.6. Loss of Label Stickers
1) When stickers on the instrument become faded or fall off, please
contact service agent 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 stirring rod.
7) In order to prevent injury, do not touch the reaction disk and sample
and reagent disk while they are spinning.
15
8) Do not install any hardware or software onto the computer comprising
the operating unit other than the software and hardware specified by
SERVICE AGENT. 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 the addition of
lubricating grease should be performed regularly.
4) If use of the instrument is stopped due to malfunction and repairs or

treatment are needed, please contact authorized 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.
16
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.
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, or machine
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.
17
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.
1.2.14. Cuvettes
The analyzers employ semi-permanent rigid cuvettes (permanent glass
cuvettes may be optionally used) with a service life of three months.
Please use cuvettes designated by manufacturer and change them
regularly. Failure to do so 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 SERVICE AGENT 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.
18
2. Installation
2.1. Installation....................................................................................................... 20
2.2. Damage Inspections....................................................................................... 20
2.3. Installation Requirements ............................................................................... 21
2.3.1.Environmental Requirements .................................................................. 21
2.3.1.1. Power Supply ........................................................................ 21
2.3.1.2. Site and Space ...................................................................... 21
2.3.1.3 Temperature, Humidity and Atmospheric Pressure .............. 21
2.3.2. Computer Requirements ......................................................................... 21
2.4. Water Supply and Drainage Requirements.................................................... 22
2.4.1. Water Supply Requirements ................................................................... 22
2.4.2 Drainage Requirements .............................................................................. 22
2.5. Connecting Fluid Lines ................................................................................... 23
2.6. Loading and Unloading of the Sample / Reagent disk................................... 25
2.7. Loading and Unloading Sample Test Tubes .................................................. 26
2.8. Loading and Unloading Reagent Bottles ....................................................... 26
2.9 Installing the System Software ............................................................................ 27
19
2.1. Installation
The auto chemistry Analyzers should only be installed by an authorized agent and the
customer must provide an appropriate environment and space for the installation.
When the analyzer needs to be relocated, please contact authorized agent.
When you receive your analyzer, please immediately notify the authorized local agent in
your area.
2.2. Damage Inspections
All analyzers are subject to a strict inspection 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 the
authorized agent in your area.
If the packaging is intact, open the box while 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.
20
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 use a UPS);
2) Proper grounding; grounding resistance less than 10mΩ; If the power supply is
poorly grounded, a copper wire of impedance less than 10 mΩ should be
connected to the protective ground terminal on 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 250kg;
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:
Wall
Waste
Outlet
5000mm or 500mm or
Less 3000mm or Less More
Operating
Unit
620mm Analysis Unit
855mm
2.3.1.3 Temperature, Humidity and Atmospheric Pressure
1) Environmental Temperature: 10 °C - 30 °C.
2) Relative Humidity: 30% - 85%, non-condensing.
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, with a CPU clock speed of 2.0 GHz or greater and more than 2.0G of
memory.
21
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 back
panel of the device;
3) Connection to Wastewater Tubing: The waste liquid discharge port should not be
more than 12 cm from ground level;
Waste
Outlet
Standard Waste
Liquid Tube
Analyzer
Sewer System
Distance from the

ground should not
exceed 12cm
Ground
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.
22
2.5. Connecting Fluid Lines
Please connect fluid lines as shown in the following Figure. A description is given
below:
1) Waste Outlet discharges wastewater used to clean the device's probes and stirring
rod; output from this outlet may be directly discharged to a municipal sewer system
or waste liquid container;
2) Waste detector used to connect the corresponding detector. Concentrated waste
detector is not used.
3) Deionized Water Inlet discharges deionized purified water to wash the instrument
channel; this inlet may be directly connected to a purified water bucket.
4) Deionized water detector used to connect the corresponding detector.
23
Figure 2-1: Fluid Line Connection Diagram
24
2.6. Installing or Removing Sample /Reagent Disk
Operation
1) When loading 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) When removing the reagent / sample disk, raise the handle of the reagent / sample
disk to the vertical position and remove the disk.
Figure 2-2: 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,
stirring rod, 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.
25
2.7. 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.
2.8. 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.
26
2.9. Installing the System Software
Operation
1) Open the software CD and click on the icon inside the host folder to begin
the AuSerNeuter_x.x.xx_xxxx.xx.xx.exe installation process. The
following windows will appear.
2) After the above installation is complete the following screen will appear.
27
3) After the above installation is complete the following screen will appear.
Click "Next."
4) In the window shown in the following Figure , select the destination folder for the
installation and then click "Next."
5) If no previous installations have been performed, the Microsoft .Net Framework 4.0
will be configured d automatically and the following window will appear. This
operation may take some time, so please be patient. Click “Install” to continue.
28
6) At the end of the installation, the following window will appear. Simply click the
"Finish" button.
29
7) Once the above installation process is complete, the software is successfully
installed. Double-click the software icon on the desktop to run the software.
8) 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.
30
9) Select the desired modules and functions, click Save and follow the prompts.
Note:
1) The V.xxx shown in the AuSerNeuter_x.x.xx_xxxx.xx.xx.exe
icon indicates the software version, which is usually expressed as a
number.
2) During software installation,

AuSerNeuter_x.x.xx_xxxx.xx.xx.exe and the tools folder must
be in the same directory.
31
3. Structure and Functions
3.1. Composition of the Analysis Unit .......................................................................... 33

3.1.1. Overall Structure.............................................................................................. 33
3.1.2. Top Structure ................................................................................................... 34
3.1.3. Rear Structure .................................................................................................. 35
3.1.4. Structure of the Left Side of the Analysis Unit............................................. 36
3.1.5 Structure of the Right Side of the Analysis Unit.......................................... 37
3.2. Function Module ...................................................................................................... 38
3.2.1. Sample Probe Aspiration Volume ................................................................. 38
3.2.2. Stirring Mechanism ......................................................................................... 39
3.2.3. Reaction Disk ................................................................................................... 40
3.2.4. Thermostatic Groove ...................................................................................... 41
3.2.5. Reagent / Sample Disk ................................................................................... 42
3.2.6. Reagent Refrigerator ...................................................................................... 43
3.2.7. Enhanced Wash Solution Position................................................................ 44
3.2.8. Optical System ................................................................................................. 44
32
The auto chemistry analyzer consists of two major components: an analysis unit and an
operating unit. The analysis unit automatically completes the operational process for each
test, including 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 Enclosur 2 Front Cove 3 Cabinet
Figure 3-1: Diagram of the Overall Structure of the Analysis Unit
33
3.1.2. Top Structure
1 4
Figure 3-2: Diagram of the Top Structure of the Analysis Unit
1: Main Enclosure 2: Reagent / Sample Pipetting Mechanism

3: Stirring Mechanism 4: Reagent / Sample Disk
5: Reaction Disk
34
3.1.3. Rear Structure
Figure 3-3: Diagram of the Rear Structure of the Analysis Unit
1: Main Power Protection Switch 2: Main Power Port
3: Communication Port
35
3.1.4. Structure of the Left Side of the Analysis Unit
Figure 3-4: Diagram of the Left Side Structure of the Analysis Unit
36
3.1.5 Structure of the Right Side of the Analysis Unit
Figure 3-5: Diagram of the Right Side Structure of the Analysis Unit
1. Analysis Unit Power Switch
37
3.2. Function Module
3.2.1. Sample Probe Aspiration Volume
Figure 3-6: Sample probe Aspiration Volume
a) Function
Draws a predetermined amount of reagent/sample from a reagent/sample tube and

discharges the reagent/sample into a cuvette.
b) Specification
Reagent: 10 - 500 μL in 1 μL increments;
Sample: 2 - 50 μL in 0.1 μL increments;
c) Action
Raises and lowers in the following positions.
1 2 3
Reagent bottle Cuvette Wash pool
38
1 2 3
Sample tube Cuvette Wash pool
d) Fluid Line Diagram
3.2.2. Stirring Mechanism
Figure 3-7: Stirring Mechanism
a) Function
Stirs the reaction solution inside the cuvette.
b) Action
39
Raises, lowers and rotates in the following positions.
3.2.3. Reaction Disk
Figure 3-6: Reaction disk Structure
a) Function
Load the cuvettes and allow the sample and reagents to react at 37°C in the reaction
Compartment. Colorimetry measurements are carried out directly using the cuvette.
b) Specification
Number of Cuvettes: 81;
Cuvette Materials: Semi-permanent Ultraviolet transmission specialty plastic;
Specification 5*5*30 (mm);
Optical Path Length: 5 mm;
40
c) Action
Clockwise rotation.
3.2.4. Thermostatic Groove
Figure 3-9: 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 ± 0.2°C;
Temperature Fluctuation: ± 0.1°C.
41
3.2.5. Reagent / Sample Disk
Figure 3-7: Diagram of the Reagent / Sample disk Structure
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 points.
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 40 ml
and 20 ml for the inner and outer rings respectively. Hitachi 7170 reagent bottles are
supported.
42
Notes:
1) Sample Position No. 39 is used exclusively for ISE cleaning and

requires the use of proprietary wash solution. Use of any other wash
solution may result in a failure to obtain the desired level of
performance.
2) 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.
3.2.6. Reagent Refrigerator
Figure 3-8: 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.
43
3.2.7. Enhanced Wash Solution Position
a) Function
Insert enhanced wash solution to clean the Sample probe and stirring rod.
b) Specification
Dedicated position 60 ml in volume.
Notes:
1) We recommend using the following enhanced wash solutions: Alkaline
Wash solution WASH DILUTION;
2) Acidic Enhanced Wash solution: 0.1 mol/L hydrochloric acid;
3) Alkaline Enhanced Wash solution: Sodium hypochlorite solution with
an effective chlorine content of 0.5%.
We recommend daily use of proprietary WASH DILUTOIN alkaline cleaning

solution for cleaning, as well as weekly use of both an acid enhanced
cleaning solution and alkaline enhanced cleaning solution (one wash each).
Please use only cleaning solutions recommended by us. Failure to do so

may result in a failure to obtain expected test results.
3.2.8. Optical System

a) Function
Measure the absorbance of the reaction solution inside the cuvette during rotation of the
reaction disk.
b) Specification
Wavelengths: 340 nm - 800 nm (can select either 670nm, 700nm or 800nm); total eight
wavelengths;
44
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
45
4. Detailed Operating Procedure
4.1. Operating Software ................................................................................................. 50

4.1.1. Basic Procedure for Logging In ..................................................................... 50
4.2. Interface Layout ....................................................................................................... 51
4.2.1.
Function Menu Area ........................................................................................ 51
4.2.2.
Submenu Function Key Area ......................................................................... 52
4.2.3.
Shortcut Button Area ....................................................................................... 52
4.2.3.1. Start ................................................................................................ 52
4.2.3.2. Suspension of Pipetting .............................................................. 53
4.2.3.3. Stop ................................................................................................ 53
4.2.3.4. Shut Down .................................................................................... 54
4.2.3.5. Emergency Shutdown ................................................................. 54
4.2.3.6. Routine Maintenance .................................................................. 54
4.2.3.7. Lock System ................................................................................. 55
4.2.4. Function Display Area ..................................................................................... 55
4.2.5. Status Bar ......................................................................................................... 55
4.2.6. Message Alert Area ......................................................................................... 55
4.3. Test Request ............................................................................................................ 57
4.3.1.
Sample Request .............................................................................................. 57
4.3.1.2. Details ............................................................................................ 58
4.3.1.4. Sample Program .......................................................................... 62
4.3.1.5. Repeat Test ................................................................................... 62
4.3.1.6. Sample Blank ............................................................................... 62
4.3.1.7. Dilution Test .................................................................................. 62
4.3.1.8. Auto Dilution Rerun ..................................................................... 63
4.3.2. QC Request...................................................................................................... 63
4.3.2.3. QC Request .................................................................................. 64
4.3.3. Calibration Request ........................................................................................ 65
4.3.3.3. Calibration Request ..................................................................... 66
4.4. Online Status ............................................................................................................ 67
4.4.1. Sample Disk Status ......................................................................................... 67
4.4.2. Reagent Disk Status ....................................................................................... 70
46
4.4.2.4. Reagent Position Settings .......................................................... 72
4.4.2.5. Reagents Scan ............................................................................. 73
4.4.2.6. Inventory ........................................................................................ 73
4.4.2.7. Reset Volume ............................................................................... 74
4.4.2.8. Release Positions ........................................................................ 75
4.4.2.9. Reagent Status ............................................................................. 75
4.4.3. Reaction Disk Status ....................................................................................... 76
4.4.4. Test List ............................................................................................................. 78
4.4.4.1. Explanation of Status and Functions ......................................... 79
4.5. Query Results........................................................................................................... 80
4.5.1.
Sample Result Query ...................................................................................... 80
4.5.1.2. Search Conditions ........................................................................ 81
4.5.1.3. Delete Sample .............................................................................. 81
4.5.1.4. Delete Item .................................................................................... 81
4.5.1.5. Rerun ............................................................................................. 82
4.5.1.6. Recalculate ................................................................................... 82
4.5.1.7. Preview / Print............................................................................... 82
4.5.1.8. Send to LIS ................................................................................... 82
4.5.1.9. Reaction Curve ............................................................................. 82
4.5.1.10. Modify Result ................................................................................ 82
4.5.1.11. View by Item.................................................................................. 82
4.5.2. Quality Control Result Query ......................................................................... 83
4.5.2.3. Quality Control Result Query...................................................... 85
4.5.3. Calibration Result Query ................................................................................ 86
4.5.3.3. Blank Correction ........................................................................... 87
4.5.3.4. Copy Cal ........................................................................................ 87
4.5.3.5. Delete ............................................................................................. 89
4.5.3.6. Send to LIS ................................................................................... 89
4.5.3.7. Calibration Curve ......................................................................... 89
4.5.4. Reagent Blank Query...................................................................................... 90
4.5.4.1. Basic Operation: ........................................................................... 91
4.6. Para. Setup ............................................................................................................... 91
4.6.1. Routine Chemistry ........................................................................................... 91
4.6.1.1. Basic Parameters ......................................................................... 92
47
4.6.1.2. Monitoring Parameters ................................................................ 97
4.6.1.3. QC Parameters ............................................................................ 99
4.6.2. Special Calculations ...................................................................................... 100
4.6.3. Panels ............................................................................................................. 103
4.6.4. Carryover ........................................................................................................ 104
4.6.5. Calibrator Setup ............................................................................................. 106
4.6.6. QC Setup ........................................................................................................ 107
4.6.7. ISE Setup........................................................................................................ 109
4.6.7.1. System Setup ............................................................................. 110
4.6.7.2. ISE Parameters ...........................................................................111
4.7. Statistical Reports .................................................................................................. 116
4.7.1.
Test Statistics ................................................................................................. 116
4.7.2. Workload Statistics ........................................................................................ 117
4.7.3. Charge Statistics............................................................................................ 119
4.7.4. Result Statistics ............................................................................................. 120
4.8. Function Settings ................................................................................................... 122
4.8.1. System Setup ................................................................................................. 122
4.8.1.1. Function Enable ......................................................................... 122
4.8.1.2. Multi-Pos. Rgt Aspirating Rules ............................................... 125
4.8.2. Hospital Setup................................................................................................ 125
4.8.2.1. Hospital Information................................................................... 126
4.8.2.2. Physician Information ................................................................ 127
4.8.3. User Management ......................................................................................... 128
4.8.3.1. Role Management ..................................................................... 128
4.8.3.2. User Setup .................................................................................. 130
4.8.4. Print Setup ...................................................................................................... 131
4.8.4.1. Template Setup .......................................................................... 132
4.8.4.2. Print Order .................................................................................. 134
48
4.8.4.3. Print List ....................................................................................... 135
4.8.5. Barcode Setup ............................................................................................... 136
4.9. System Maintenance............................................................................................. 139
4.9.1. Routine Maintenance .................................................................................... 139
4.9.1.1. Routine Maintenance Commands ........................................... 139
4.9.1.2. ISE Calibration............................................................................ 140
4.9.1.3. ISE Maintenance ........................................................................ 141
4.9.2. Log Management ........................................................................................... 146
4.9.3. Temperature Curve ........................................................................................ 148
4.9.4. Enter Maintenance ........................................................................................ 149
4.9.5. Three-Probe Parameter Configuration ....................................................... 149
4.9.5.1. Sample Probe Parameter Configuration................................. 149
4.9.5.2. Stirring Rod Parameter Configuration ..................................... 150
4.9.5.3. Sample Probe Wall Pump Parameters Configuration .......... 150
4.9.5.4. Mixer Wash Pump Parameters Configuration ....................... 151
4.9.5.5. Introduction to Parameters and Features ............................... 151
49
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 open
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 boot process, change the login password and perform database backup /
restore operations.
Figure 4-2: Main interface of the operating software
50
4.2. Interface Layout
The operating interface of the auto chemistry analyzer includes a function button area,
function display area, status bar and alert message area, as shown below:
Figure 4-3: Main interface of the operating software
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 7 submenus: routine chemistry, calculation chemistry, Panels,
Carryover, ISE setup, calibrator setup and QC setup.
51
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 curves, enter maintenance 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:
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;
52
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.
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.
53
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

If you wish to perform a standard shutdown, click on the "OK" button directly;
Notes:
Select "Turn off the computer" to automatically turn off the computer after
system shutdown.
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:
54
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.
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, wash solution, waste liquid container and LIS connection
status. Lamp, temperature, wash solution and waste liquid container statuses are directly
displayed as icons and cannot be interacted with; Double click the LIS icon to open the LIS
Settings dialog box where you can setup and connect to LIS. See below:
Figure 4-6: "LIS" Setup Interface Screen
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;
55
the following function buttons are available:
"C": Clears the current message.
"A": Error log. Click to view information recorded by the system related to various errors.
"V": Check the software name and version information
: View the "previous" or "next" message
: View help information
56
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.
Sample Position Refers to the disk position number (total of 40 possible) of the
57
Parameter Meaning
selected 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
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
58
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
59
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
60
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
Request List View already-requested samples and the project; can perform
61
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.
62
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 Function Key Schematic

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
63
Parameter Meaning
vial list
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, sample position and control solution and enter the sample
number;
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.
64
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
65
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.
66
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 tests currently being carried out by
the instrument. 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, Delete, 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
67
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 Red Sample currently being tested
Finished Green All tests for the sample have been completed
Incomplete Dark Red Insufficient sample margin
Insufficient Yellow Test completed, but, due to various causes, a

Sample result cannot be computed
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
Heptagon A dilute solution is in the corresponding position
68
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, Delete, 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 on retest after to
perform a repeat test
Delete Delete all information corresponding to the selected sample
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)
69
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 Item 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
70
corresponding operations.

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 Light Gray A dilute solution is in the corresponding position
R1 Light Blue Reagent 1 is in the current position
R2 Purple Reagent 2 is in the current position
Shared Red The current reagent position is shared by reagents

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

Brown a project
In addition, the circle area in the center of a given reagent position will appear blank, yellow,
red or blue 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
71
Lot No. Lot Number Information for the The user need only enter the lot
Reagent Kit number information provided with
the reagent kit
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.

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 vial 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;
72
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.
73
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
74
message will pop up;
8) Otherwise, click the "Back" button to cancel resetting the residual volume.
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
75
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 8 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 added to a test
Dirty Dark The cuvette is not clean, or the cuvette is already occupied
cuvette Red with waste product (e.g. voided test)
Dilution Lemon Dilution is currently being performed in the current cuvette

position
R1 Green Addition of a first reagent for a given test
76
S Navy Addition of a sample for a given test
R2 Purple Addition of a second reagent for a given test
End1 Light The current test ended normally but the corresponding
Blue results have yet to be computed
End2 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

Item
cuvette
Results 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
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:
77
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.
4.4.4. Test List

You can view information for tests that are pending, in progress, waiting list or invalidated.
Figure 4-18: The "Test List" Screen
78
4.4.4.1. Explanation of Status and Functions
Includes 4 different statuses: pending, in progress, queued or invalidated. 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
Pending The items in this list have already been requested but testing
has yet to be initiated and they cannot be operated on
In Progress Already undergoing testing or the system has already allocated

a list of test information
Waiting List The test has been started and is currently waiting for the system
to arrange the test - cannot be operated on
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
79
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 number, 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;
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 query criteria, delete
sample and delete item allowing the user perform corresponding operations.
80
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
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 Item

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 Item" 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
Item" operation.
81
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. Send to LIS

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
reaction curve corresponding to the current results record.
4.5.1.10. Modify Result

The "Modify Result" function allows the user to modify a single result or modify a large batch
of results on an item by item basis. The user can select the desired mode based on his or
her specific needs.
4.5.1.11. View by Item

Click the "by Item" button to enter the View Results by Item screen which includes the
following 5 functional buttons: Search, Delete Item, Recalculate, By sample and Results
chart. The Search, Delete Item, 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.
82
Figure 4-21: The "Sample Results Query - View by Item" 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: multi-rule quality control
charting, accumulation and quality control charting and twin plot charting; Quality control data
can be displayed by either quality control liquid or item.
Figure 4-22: The "Quality Control Result Query" Screen
83
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
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
84
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
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
85
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 Date/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"
Default Signs the current default calibration results
Rgt Blk Reagent blank data used during calibration
Calibration Parameter Displays calibration parameters derived from linear
86
Parameter Meaning and Basic Operation
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.
87
Figure 4-25: The "Copy Calibration" Function Screen
88
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
89
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
90
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 Standard Item, Computation Item, Panels, Cross-Contamination, ISE Settings,
Calibration Settings and Quality Control Settings menus. Each menu can be used to invoke
corresponding functions.
4.6.1. Routine Chemistry

When including basic parameters, monitoring parameters, quality control parameters and
standard item parameter settings, setting are performed preferentially in the following order: “Basic
Parameters” → “QC Parameters” → “Monitoring Parameters”. These are described in detail
below:
91
4.6.1.1. Basic Parameters
Figure 4-28: "Standard Item" 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)
92
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: rising reaction and falling reaction
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
93
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

Alarm No. tests for a given
reagent kit
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 - 500 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 - 350 μl and can be adjusted in
test. Value is 1 μl increments
microliters
94
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
95
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
Up Changes the order in Click the "Move Up" button to move the item
which tests are ahead in the current test sequence
displayed for a given
item in the Item
Abbreviation Field
Down Changes the order in Click the "Move Down" button to move the
which tests are item back in the current test sequence
displayed for a given
item in the Item
Abbreviation Field
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.
96
4.6.1.2. Monitoring Parameters
Introduction of Basic 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
97
point data for which substrate

depletion has not occurred,
including delay times
(⊿ 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
98
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 Basic 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
99
Conclusion Indicates determination regarding No operation

sources of error for Westgard
loss-of-control rules. Should only
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. Special Calculations
Figure 4-31: "Computational Item" Parameter Settings Screen
100
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
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
101
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
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;
to delete the currently-selected computational item(s)?")and click the "Yes" button
to delete the item or click "No" to cancel deletion of the item.
102
4.6.3. Panels
Figure 4-32: "Panels" Parameter Settings Screen
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
103
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;
to delete the currently-selected panel(s)?") and click the "Yes" button to delete the
item or click "No" to cancel deletion of the item.
4.6.4. Carryover
Figure 4-33: "Carryover" Parameter Settings Screen
104
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,
click the "Save" button.
105
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
Barcode Barcode of the calibrator Enter directly in the box or click on
the "Scan" button in the sample disk
screen to display directly
106
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;
to delete the currently-selected calibrator(s)?") 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.
4.6.6. QC Setup
Figure 4-35: The "QC Setup" Screen
107
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
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
108
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;
to delete the currently-selected quality control solution(s)?")and click the "Yes"
button to delete the quality control solution or click "No" to cancel deletion of the
quality control solution.
3) When finished, click the "Close" button to exit the quality control solution
settings screen.
4.6.7. ISE Setup

Includes System Setup and ISE parameters. When setting up ISE parameters setup is
performed in the following order “System Setup” → “ISE Parameters”. These will be
described separately.
109
4.6.7.1. System Setup
Figure 4-36: The "System Setup" Screen
For explanations of different parameters and operations corresponding to the "System

Place a "☑" next to the "Include ISE Module"

Select whether to
Select ISE option to select the ISE module and place a "☑" in
include the ISE
Module front of the K, Na, Cl and Li options to select ISE
module
items that need to be supported by the instrument;
Option which
Select "Start ISE cleaning automatically when the
determines whether
system is turned on" or "Start ISE cleaning
or not an ISE
Switch automatically when the system is turned off" by
cleaning is
Setup placing a "☑" in the appropriate box to indicate that
performed when the
you would like ISE cleaning to be performed during
instrument is
system power-on or power-off respectively;
powered on or off
Automatically Enter a time into the box included in the

request a calibration "Automatically request a calibration after □ hours"
after a certain time string to force the instrument to automatically
Interval interval or perform an ISE calibration test after the specified
Setup automatically interval; Enter a number into the box included in the
perform ISE "Perform an ISE cleaning after testing □ samples"
cleaning following string to force the instrument to perform an ISE
a certain number cleaning after a certain number (corresponding to
110
of tests the number entered) of tests are complete;
Introduction to Application Features
For an explanation of the function of the buttons present in the "System Setup" screen,
see the table below:
Button Function
Save Enter appropriate basic ISE System Setup data and click on this button
to save the settings.
4.6.7.2. ISE Parameters

Includes settings for both basic information as well as QC parameters; when setting ISE
parameters, setup is performed in the following order: “basic information” → “QC
parameters”. These are described in detail below:
1) Basic Information
The Basic Information Screen found under the ISE Parameters menu is as shown below:
Figure 4-37: The "ISE Parameters - Basic Information" Screen
For explanations of different parameters and operations corresponding to the "ISE

Parameters - Basic Information" screen, see the following table:
111
Standard Number Standard serial numbers for ISE /

items supported by the instrument,
including four standard serial
numbers for K, Na, Cl and Li.
Cannot be edited;
Item Item abbreviation for ISE items /

supported by the instrument,
including four items: K, Na, Cl and
Li. Will always be consistent with
with corresponding ISE item
standard serial numbers and
cannot be edited
Chemistry ISE item shortened name. Will /

abbreviation always be consistent with with
corresponding ISE item standard
serial numbers and cannot be
edited
Chemistry full name ISE item full name 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)
Results accuracy The accuracy of ISE item results Click on the drop-down box
and select from the
following options: "0, 0.0,
0.00, 0.000" or select the
"..." button to enter the Data
Dictionary Maintenance
screen where you can freely
edit the number of decimal
places given;
Unit ISE item result units Click on the drop-down box

and select the "..." button to
enter the Data Dictionary
Maintenance screen where
you can freely edit the units
in which results are
displayed;
112
Type By selecting a particular sample Select the test sample type

type it is possible to filter the (serum / plasma or urine)
quantitative range and qualitative
results display for different sample
types used by the
currently-selected ISE item.
Measurement ISE item test range Input directly into the box
Range
Modified slope Correction is not performed by Input directly into the box
default. When a correction is
Modified intercept performed, the correction is made Input directly into the box
according to the formula Y = KC + b
using the slope and intercept
entered by the user, where K is the
correction slope, b is the correction
intercept, C is the pre-correction
result and Y is the corrected result.
Ref Range Normal reference range for ISE Right-click on the blank
item results area underneath the
"reference range lower limit"
string to add a reference
range or delete information
related to the reference
range selected by the
cursor, including
classification, gender,
sample type, age lower
limit, age upper limit and
age units;
Ref Range Lower Enter the default lower limit of the Enter a specific value in the
Limit reference range box based on the reference
range provided by the
reagent's manual or other
professional reference book
Ref Range Upper Enter the default upper limit of the Enter a specific value in the
Limit reference range box based on the reference
range provided by the
reagent's manual or other
professional reference book
113
The QC Parameters Screen found under the ISE Parameters menu is as shown below:
Figure 4-38: The "ISE Parameters - QC Parameters" Screen
2) QC Parameters
For a basic explanation of the QC Parameters screen found under the ISE Parameters
menu, see the following table:
Westgard QC Set an item's Westgard multi-rule Place a "☑" next to a rule to

rules quality control select it
Explanation of the conditions for No operation

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

QC sources of error for Westgard
determination loss-of-control rules. Should only be
used as a guide
Accumulation Set an item's cumulative sum quality Select directly from the
and QC rules control rules drop-down box
114
For an explanation of the function of the buttons present in the "ISE Setup" screen, see
the table below:
Button Function
Save Enter appropriate basic ISE system information and click on this
button to save the settings.
Cancel Click on this button to cancel information which has already been
entered and return to the default state.
Basic Operations
Set or modify ISE item parameters
1) Select a preset or modify a QC item;
2) Set or modify basic information and Westgard QC rules;
3) Select or modify cumulative sum QC rules;
4) Click the "Save" button or click "Cancel" to discard the changes.
115
4.7. Statistical Reports
Includes four subsections: test statistics, workload statistics, cost 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 4-39: 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" and "By Sample" No operation
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
116
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 4-40: The "Workload Statistics" Screen
117
For explanations of different parameters and operations corresponding to the "Workload
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.
118
4.7.3. Charge Statistics
The "Charge Statistics" menu is shown below:
Figure 4-41: 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
119
Item Name of the test item Selected from a
drop-down box

 Statistics
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 4-42: The "Result Statistics" Screen
120
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
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.
121
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 seperate
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.
4.8.1.1. Function Enable
Figure 4-43: The "Function Activation" Screen
 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
sample request screen will display
122
Suffix 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
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
123
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:
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
124
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 4-44: The "Multiple Reagent Position and Aspirating Rules" Settings Screen
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.
125
4.8.2.1. Hospital Information
Figure 4-45: 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
126
Shows the physician's number, name, rank

Doctor List None
and additional remarks
For an explanation of the function of the "Hospital Information" screen buttons and the
operation thereof, see the following table:
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. Physician Information
Figure 4-46: The "Doctor Information" Settings Screen
127
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
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:
128
Figure 4-47: 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 After adding or modifying records in the data list, click this button to
129
Button Function
save the changes.
4.8.3.2. User Setup

Used to assign appropriate roles to the user:
Figure 4-48: The "User Setup" Settings Screen
130
For explanations of different parameters and operations corresponding to the "User

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
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.
131
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 4-49: The "Template Setup" Screen

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

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
132
Report Type Detail
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,
Button Function Description
Add new Adds new printing templates

template
Edit Template Allows the user to edit template formats that already exist within the
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
133
4.8.4.2. Print Order
Figure 4-50: The "Print Order" Settings Screen
For an explanation of the function of the "Print Order" 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
Use the drop-down menu to select the desired location and move
Move to
the selected item directly to the specified location
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
Refresh Displays the item print order saved to the current database
134
4.8.4.3. 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 4-51: 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
Clear Sequence Deletes all failed print jobs currently on the print list
Delete task Deletes the selected failed print job
135
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 4-52: 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.
For example: If a sample barcode only includes the serial number and
date of the sample, then when the barcode is analyzed, the number
136
Parameter Meaning
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
and end positions respectively.
137
Parameter Meaning
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 20ml, inner 40ml. 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.
138
4.9. System Maintenance
4.9.1. Routine Maintenance

Includes daily commands, ISE calibration and ISE maintenance. Here we will discuss these
aspects in the following order: “daily commands” → “ISE calibration” → “ISE maintenance”.
4.9.1.1. Routine Maintenance Commands
Figure 4-53: The "Daily Commands" Screen
Description of Command Functions
Click send after

Machine Self-test
Self-test retest of the whole machine selecting the command
Reset
to execute
This operation can be performed when the

Click send after
instrument malfunctions so that the
Failure Recovery selecting the command
machine can recover from a malfunctioning
to execute
state to a normal one
Click send after

Mixing bar
Cleaning of the stirring rod selecting the command
Cleaning
to execute
Mixing bar Uses an alkaline cleaning solution to Click send after

Enhanced perform an intensive cleaning of the selecting the command
Cleaning stirring rod to execute
139
Click send after

Sample Probe
Ordinary cleaning of the sample probe selecting the command
Cleaning
to execute
Sample Probe Uses an alkaline cleaning solution to Click send after

Enhanced perform an intensive cleaning of the selecting the command
Cleaning sample probe to execute
Performs a cuvette blank test and replaces Click send after

Cuvette Blank
the cuvetteok,A78 blank data currently selecting the command
Test
being used to execute
4.9.1.2. ISE Calibration
Figure 4-54: The "ISE Calibration" Screen
140
For explanations of different parameters and operations corresponding to the "ISE

Calibration" screen, see the following table:
Includes both calibration results and

ISE Item calibration times. Displays the most current
ISE calibration results
This condition contains all calibration testing

Recall Results results within the search period for the
Select the calibration
current calibration
start and end times
in the search
Calibration A list of all calibration results within the
criteria and click the
Results search conditions
"Search" button
The time over which calibration results within
Cal Date
the search conditions are operated
ISE Calibration A trend chart showing calibration results

Trends Chart obtained under the current search conditions
For an explanation of the function of the "ISE Calibration" screen buttons and the
Button Function
Calibration Performs an ISE calibration operation
Query Search for all calibration results within the given search conditions
Print Image Prints out a graphic of search results trend
Print Data Prints out all ISE calibration results which match the query criteria
4.9.1.3. ISE Maintenance

Click the "ISE Maintenance" button to enter the "ISE Maintenance" screen. In this dialog box,
you can view the usage time and number of tests for each electrode in a given ISE module
as well as the usage time of various disposable supplies (reagents, calibrators) and perform
ISE maintenance commands.
141
Figure 4-55: The "ISE Maintenance" Screen
For an explanation of the function of the "ISE Maintenance" screen buttons and the
Button Function
Replacement See the "Replacement Parts" section below

Parts
Check Reagent Issues a reagent kit information query command, reads reagent kit
Kit information and refreshes the status display for the given reagent kit
Replace Click this button to have the system ask whether or not you want to
Reagent Kit replace the reagent kit. After replacing the reagent kit, click "OK" and
the system will automatically refresh the reagent kit status display.
Execute See the "Execute Command" section below

Command
Replacement Parts
In the "ISE Maintenance" screen, select a part that needs to be replaced in the ISE parts
status list, click the "Replacement Parts" button to bring up the "Replace ISE Parts"
dialog box and perform a parts replacement. Once complete, refresh the part's
replacement and repair status.
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Figure 4-56: The "Replace ISE Parts" Screen
 The meanings of parameters contained in the "Replace ISE Parts" dialog box are
shown below
Parameter Meaning
Part names Name of the component which needs to be replaced.
Recent Refers to the most recent time the specified part was replaced. This
Replacement parameter is not modifiable.
Time
Rated Test Allows the user to enter the maximum working life of each part following
Time replacement. When the maximum working life of a part has been
exceeded, the corresponding notes section will indicate to the user that
the part needs to be replaced.
Rated Test Allows the user to enter the maximum allowed number of tests for each
Times electrode. When the actual number of tests performed for a given
electrode exceeds this maximum, the corresponding notes section will
indicate to the user that the electrode needs to be replaced.
Comments Allows the user to enter notes at the time of part replacement
 For explanations of the functions of buttons contained in the "Replace ISE Parts"
dialog box, see the table below:
Button Function
OK Click this button to save parts maintenance information.
Exit Click this button to close the "Replace ISE Parts" dialog box and cancel
parts maintenance.
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Execute Command
After an ISE module has been in prolonged use, the user should carry out necessary
maintenance in order to prolong the module's life. An explanation of ISE maintenance
commands and operations is given in the following table:
ISE Command Objective Execution Steps

Maintenance
Command
Two-point Calibrates the ISE 1. Select the "Two-point Calibration" command

Calibration electrodes. and click on "Execute Command" to bring up a
confirmation dialog box;
2. Click "Continue" to begin ISE calibration.
The status box will be automatically closed after
the calibration is complete.
Cleaning Clears protein 1. Select the "Cleaning Cycle" command and

Cycle deposits on the ISE click on "Execute Command" to bring up a
electrode. confirmation dialog box;
2. Click "Continue" to begin cleaning of the ISE
electrodes. The status box will be automatically
closed after the calibration is complete.
Maintenance Used to clear Liquid A 1. Select the "Maintenance Cycle" command

Cycle from the flowline and click on "Execute Command" to bring up a
corresponding to the confirmation dialog box;
machine's electrodes.
2. Click "Continue" to start the maintenance
Useful for
cycle. The status box will be automatically
maintenance
operations such as
electrode
replacement.
Pump Performs calibration 1. Select the "Pump Calibration Cycle"

Calibration of the ISE module command and click on "Execute Command" to
Cycle peristaltic pump. bring up a confirmation dialog box;
2. Click "Continue" to begin pump calibration.
Bubble Performs calibration 1. Select the "Bubble Detector Calibration Cycle"

Detector of the bubble detector command and click on "Execute Command" to
Calibration to ensure that bring up a confirmation dialog box;
Cycle bubbles are detected
2. Click "Continue" to begin bubble detector
accurately.
calibration. The status box will be automatically
ISE When the ISE module 1. Select the "Failure Recovery" command and
Malfunction malfunctions, the user click on "Execute Command" to bring up a
144
ISE Command Objective Execution Steps
Maintenance
Command
Recovery can execute this confirmation dialog box;
command to repair
2. Click "Continue."The system will initiate
the issue.
recovery of the ISE module, and the status box
will be automatically closed after the calibration
is complete.
Purge A Cycle Uses the Solution A 1. Select the "Purge A Cycle" command and
wash reagent kit on click on "Execute Command" to bring up a
inter-ISE module confirmation dialog box;
tubing.
2. Click "Continue" to start the purge cycle. The
status box will be automatically closed after the
calibration is complete.
Purge B Cycle Uses the Solution B 1. Select the "Purge B Cycle" command and
wash reagent kit on click on "Execute Command" to bring up a
inter-ISE module confirmation dialog box;
tubing.
2. Click "Continue" to start the purge cycle. The
status box will be automatically closed after the
calibration is complete.
Purification Simultaneously uses 1. Select the "Purification Combination"

Combination the Solution A and command; in the "Command Parameters" area
Solution B wash set the number of purifications performed using
reagent kits on the Solutions A and B and click "Execute Command"
systems inter-ISE to bring up a confirmation dialog box;
module tubing. The
2. Click "Continue" to start the purification cycle.
number of times
Solution A and
Solution B are
respectively used can
be set manually.
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4.9.2. Log Management
Figure 4-57: 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
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
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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
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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.
Figure 4-58: 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 The default interval is 30s between
Monitoring Cycle for monitoring data temperature measurements; The
Test user can opt to have temperature
Temperature monitoring performed according to
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Data 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
4.9.4. Enter Maintenance

This chapter will be described in greater detail in the maintenance manual.
4.9.5. Three-Probe Parameter Configuration

Click to enter the Probes Parameters screen which includes four primary settings menus:
Sample Probe Parameters, Mixing Bar Parameters, Reaction disk Optical System
Parameter and Peristaltic Pump Parameter. The users can adjust and set sample probe,
stirring rod and reaction disk optical and electrical parameters as well as peristaltic pump
operating parameters to ensure normal operation of the instrument.
4.9.5.1. Sample Probe Parameter Configuration

See section 4.9.5.5 for a detailed description of the various parameters and function buttons
in this menu.
Figure 4-59: The "Sample Probes Parameters" Screen
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4.9.5.2. Stirring Rod Parameter Configuration
in this menu.
Figure 4-60: The "Mixing Bar Parameters" Screen

4.9.5.3. Sample Probe Wall Pump Parameters Configuration
in this menu.
Figure 4-61: The "Sample probe wall pump " Screen
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4.9.5.4. Mixer Wash Pump Parameters Configuration
in this menu.
Figure 4-62: The "Mixer Wash Pump Parameter" Screen

4.9.5.5. Introduction to Parameters and Features
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
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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 Stores modified configuration parameters on the computer

configuration
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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5. Simplified Operating Procedures
5.1. Operational Procedures for Basic Functions ..................................................... 155

5.1.1. Add Item .......................................................................................................... 155
5.1.2. Change Item Parameters ............................................................................. 155
5.1.3. Delete Item ..................................................................................................... 155
5.1.4. Add Control Solution ..................................................................................... 156
5.1.5. Modify Control Solution................................................................................. 157
5.1.6. Delete Quality Control Solution ................................................................... 157
5.1.7. Add New Calibrator ....................................................................................... 157
5.1.8. Modify a Calibrator ........................................................................................ 157
5.1.9. Delete a Calibrator......................................................................................... 158
5.1.10.Set Reagent Positions .................................................................................. 158
5.1.11.Modify Reagent Information ......................................................................... 158
5.1.12.Release Reagent Positions .......................................................................... 159
5.1.13.Reagent Blank Test Procedure .................................................................... 159
5.1.13.1. Request ....................................................................................... 159
5.1.13.2 Testing.......................................................................................... 159
5.1.14. Calibration Test Procedure ........................................................................... 160
5.1.14.1. Request ....................................................................................... 160
5.1.14.2 Testing.......................................................................................... 160
5.1.15. Quality Control Test Procedure.................................................................... 161
5.1.15.1. Request ....................................................................................... 161
5.1.15.2 Testing.......................................................................................... 161
5.1.16 Sample Testing Procedure ........................................................................... 161
5.1.16.1. Request ....................................................................................... 161
5.1.16.2 Testing.......................................................................................... 162
5.2. Operating Procedures for Opening a New Item ................................................ 163
5.3 Routine Operational Procedures ......................................................................... 164
5.3.1. Pre-Startup Check ......................................................................................... 164
5.3.2. Powering On the System .............................................................................. 165
5.3.3. Order of Operational Procedures ................................................................ 165
5.3.4. System Setup ................................................................................................. 166
5.3.5. Item Parameter Settings ............................................................................... 166
5.3.6. Reagent Position Settings ............................................................................ 166
5.3.7. Setup ............................................................................................................... 166
5.3.8. QC Settings .................................................................................................... 166
5.3.9. Test Request .................................................................................................. 166
5.3.10. Test Preparation ............................................................................................. 167
5.3.11. Start.................................................................................................................. 167
5.3.12. Test Result Query .......................................................................................... 168
5.3.12.1. Calibration Result Query ........................................................... 168
5.3.12.2. Quality Control Result Query.................................................... 168
153
5.3.12.3. Sample Results Query .............................................................. 168
5.3.12.4 Reagent Blank Query Results.................................................. 169
5.3.13. Adding Tests ................................................................................................... 169
5.3.14. Shutdown ........................................................................................................ 169
5.3.15. Powering Off the System.............................................................................. 170
5.3.16 Post-Shutdown Inspection ........................................................................... 170
154
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 size, 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:
5.1.3. Delete Item
155
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 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.
156
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;
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
157
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
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 cuvette, 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) Enter 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;
158
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
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 Entire disk" 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.
159
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;
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.
160
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;
5) Select a test item;
161
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;
162
5.2. Operating Procedures for Opening a New Item
1) For the current item add 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.
163
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 5ml of 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 (for instrument with ISE module);
6) Check that pure 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, stirring rod 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 covers;
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.
164
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;
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) Measure cuvette blank;
7) Check for dirty cuvettes.
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 bulb if necessary.
165
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.
Notes: Analysis Parameters

Incorrect analysis parameters can lead to erroneous measurement results.
Please consult 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. 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.
166
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;
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.
167
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;
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.
168
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
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 in the following order (will
require approximately 6 minutes):
1) Drain all cuvettes;
2) Fill all cuvettes with pure 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) If you choose the long holiday shutdown option then you need only
perform Steps 1 and 3 (will require approximately 2 minutes).
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.
169
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;
3) Wipe down the analyzer countertop;
4) Wipe off any contaminants or water droplets present on the apparatus probe,
stirring rod.
170
6. Analysis Principles and
Computational Methods
6.1. Analysis Principle................................................................................................... 172

6.2. Analysis Procedure ............................................................................................... 172
6.2.1. Actions Performed by the Device ................................................................ 172
6.2.2. Operating Position ......................................................................................... 173
6.2.3. Testing Process.............................................................................................. 173
6.2.4. Optical Metering Point................................................................................... 174
6.3. Analysis Methods and Reactivity Calculations .................................................. 175
6.3.1.
Absorbance Calculation ................................................................................ 175
6.3.2.
Endpoint Method ............................................................................................ 176
6.3.2.1. Single Reagent Endpoint Method ............................................ 176
6.3.2.2. Double Reagent Endpoint Method .......................................... 179
6.3.3. Two-Point Method (Fixed-Time Method) .................................................... 181
6.3.3.1. Single Reagent Two-Point Method .......................................... 181
6.3.3.2. Double Reagent Two-Point Method ........................................ 182
6.3.4. Kinetic Method ............................................................................................... 183
6.3.4.1. Single Reagent Kinetic Method................................................ 183
6.3.4.2 Double Reagent Kinetic Method .............................................. 184
6.4. Calibration ............................................................................................................... 186
6.4.1. Calibration Types ........................................................................................... 186
6.4.2 Calculation of Calibration Parameters ............................................................ 186
6.5. Results Calculation ................................................................................................ 187
6.6. QC ............................................................................................................................ 188
6.6.1. Quality Control Rules and Determination................................................... 188
6.6.1.1. Westgard Multi-Rule .................................................................. 188
6.6.1.2. Cumulative Sum ......................................................................... 189
6.6.1.3 Twin Plot ...................................................................................... 189
6.6.2. Quality Control Query ................................................................................... 189
6.6.3 QC Charting.................................................................................................... 189
6.7 Other Related Calculations .................................................................................. 191
6.7.1. Calibration Curve-Related Calculations ..................................................... 191
6.7.2. Substrate Depletion Determination ............................................................. 193
6.7.3. Linearity Test .................................................................................................. 193
6.7.4. Prozone Check............................................................................................... 194
6.7.5. Determination of Lamp State ....................................................................... 196
6.7.6 Examination of Cuvette Cleanliness ........................................................... 196
171
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

The analyzer perform the following actions in a cyclical fashion to complete all assigned
tests:
1) The reaction disk turns by 87 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 90 cuvette
positions and the system pauses. This is referred to as a single cycle;
2) From the 1st to the 81st 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;
172
6.2.2. Operating Position
6.2.3. Testing Process

The analyzer feature fixed testing procedures with each reaction including a total of 60 test
cycles. In high speed mode, each cycle lasts 15 seconds while in standard mode each cycle
lasts 22.5 seconds, as shown in the Figure below:
173
6.2.4. Optical Metering Point
For a given reaction, a single optical measurement is taken once every cycle for a total of 60
optical metering points. In high speed mode, the time interval between two adjacent optical
metering points is 15 seconds; In standard mode, the time interval between two adjacent
optical metering points is 22.5 seconds, as shown in the Figure below:
Absorbance
Add R1 Add S Add R2
60 Optical
1 9 10 18 19 Metering Point
174
6.3. Analysis Methods and Reactivity Calculations
6.3.1. Absorbance Calculation

The formula used to calculate absorbance (A) by the SERVICE AGENT 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 pure 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 SERVICE AGENT
analyzer 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 SERVICE AGENT 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.
175
 Blank Time [L] [M]: The time before a reaction for a given test is started.
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 6-1 Single Reagent Endpoint Methods A and B Reaction Curves
Endpoint Method A
Reaction time [N] [P], 10 ≤ N ≤ P ≤ 60, where P ≤ N +4;
Blank time [L] [M], 1 ≤ L ≤ M ≤ 9, where M ≤ L +4; L and M default to 9.
The formula by which reactivity (R) is calculated is as follows:
R  Ai  kAb
176
Where:
VR1
1) k is a single reagent volume correction factor and V R1 and V S
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.
A  AN 1
That is: Ai  N .
c) If P = N +2, then the2 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 ≤ 60, where P ≤ N+4;
Blank time [L] [M], 1 ≤ L ≤ M ≤ 9, where M ≤ L +4; L and M default to 9.
The formula by which reactivity (R) is calculated is as follows:
R  Ai  Ab
177
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 6-2 Single Reagent Endpoint Method C Reaction Curves
Reaction time [N] [P], 10 ≤ N ≤ 12 < P ≤60;
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.
178
6.3.2.2. Double Reagent Endpoint Method
R2
R1 S
Optical
L M N P Metering Point
Figure 6-3 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:
V R1  VS
1) k'  is a double reagent volume correction factor and V R1 , V S
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, R R 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.
179
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 6-4 Double Reagent Endpoint Method C Reaction Curve
Reaction time [N] [P], 19 ≤ N ≤ 21 < P ≤60;
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.
180
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 6-5: The Single Reagent Two-Point Method Reaction Curve
Reaction time [N] [P], 10 ≤ N < P ≤ 60;
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 A N represent the absorbance values during the Pth cycle and
Nth cycle respectively;
181
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
'
V R1
single reagent volume correction factor, K  .
V R1  VS
6.3.3.2. Double Reagent Two-Point Method
Figure 6-6: The double Reagent Two-Point Method Reaction Curve
Reaction time [N] [P], 19 ≤ N < P ≤ 60;
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
'
182
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 R R 2 is calculated in the same way as reactivity R above. The second
reagent blank corrected reactivity is expressed as R '' = R - R R 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 absorbence 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 6-7: Single Reagent Kinetic Method Reaction Curve
183
Reaction time [N] [P], 10 ≤ N ≤ P ≤ 60 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
'
V R1
volume correction factor, K  .
V R1  VS
6.3.4.2 Double Reagent Kinetic Method
A
S R2
R1
Optical
L M N P
Metering Point
Figure 6-8: The Double Reagent Rate Method Reaction Curve
Reaction time [N] [P], 19 ≤ N ≤ P ≤ 60 and P ≥N+2, so at least 3 optical metering points
are needed;
184
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 R R 2 is calculated in the same way as reactivity R above. The second
''
reagent blank corrected reactivity is expressed as R = R - R R 2 .
185
6.4. Calibration
6.4.1. Calibration Types

For SERVICE AGENT 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.
186
4) Logit-4P
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.
187
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
188
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 QCUsed to perform a quality control status analysis on 10 consecutive quality

control data points in a day;
Intraday QCUsed to perform a quality control status analysis on all quality control data
points in a given day;
Inter-Day QCUsed 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) CUSUM 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
189
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.
190
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
191
 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.
192
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
193
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 ≤60
Absorbance
P
N
Optical
Metering Point
194
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 ≤60
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;
195
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 81# - 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 81# - 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 water blank for any one of the 12 tested wavelengths
is smaller than 50% of its initial value, the user is alerted to the presence of a dirty
cuvette.Each time the water 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 water blank AD value of the cuvette at the tested wavelength to the
corresponding initial value.
196
7. Care and Maintenance
7.1. Preparation of Tools............................................................................................... 198

7.2. Daily Maintenance ................................................................................................. 198
7.2.1.
Wiping Down the Analyzer Countertop....................................................... 198
7.2.2.
Cleaning the Sample Probe / Stirring Rod ................................................. 199
7.2.2.1. Cleaning the Sample Probe...................................................... 199
7.2.2.2 Cleaning the Stirring Rod .......................................................... 200
7.2.3. Inspecting the Reagent / Sample Syringe ................................................. 200
7.2.4. Inspecting the Purified Water Bucket ......................................................... 202
7.2.5 Inspecting the Waste Liquid Container / Tubing ....................................... 203
7.3. Weekly Maintenance ............................................................................................. 204
7.3.1. Cleaning the Primary Purified Water Filter ................................................ 204
7.3.2. Cleaning the Waste Liquid Container ......................................................... 205
7.3.4 Cleaning the Reagent / Sample Disk Refrigeration Unit....................... 205
7.4. Monthly Maintenance ............................................................................................ 206
7.4.1. Cleaning the Cleaning Pool.......................................................................... 206
7.4.2. Cleaning the Thermostatic Groove of the Reaction Disk ........................ 207
7.4.3. Wiping the Driving Rod ................................................................................. 208
7.4.4 Cleaning the Dust Filter ................................................................................ 208
7.5. Semi-Annual Maintenance ................................................................................... 208
7.5.1. Replacing the Primary Stage Filter ............................................................. 208
7.5.2 Replacing the Second Stage Filter ............................................................. 209
7.6. Unscheduled Maintenance ................................................................................... 209
7.6.1. Unblocking the Sample and Reagent Probes ........................................... 209
7.6.2. Replacing the Sample Probe ....................................................................... 210
7.6.3. Replacing the Stirring Rod ........................................................................... 212
7.6.4. Replacing the Lamp ...................................................................................... 213
7.7. Replaceable Device List ....................................................................................... 215
7.7.1. The following is a list of items that can be replaced by the user ......... 215
7.7.2 List of Parts that Require a Maintenance Engineer for Replacement ... 215
7.8 Maintenance Log ................................................................................................... 216
197
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.

The countertop should be considered a source of contagion and gloves
should be worn during handling.
198
7.2.2. Cleaning the Sample Probe / Stirring Rod
When the exterior and tip of the sample probe or surface of the stirring rod 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 no
foreign matter remains on the probe.
199
7.2.2.2 Cleaning the Stirring Rod
Figure 7-2: Wiping Down the Stirring Rod
1) Move the stirring rod to the appropriate position;
2) Soak a piece of clean gauze in ethanol and gently wipe the flat part of the stirring rod
until no foreign matter 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.
Figure 7-3: The Syringe
200
Check the knob of the Finger-tight fitting, if syringe any leaks are identified,
tighten it. If not be solved, please contact SERVICE AGENT ; When finished, close
the cover on the left side of the analysis unit.
201
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.
202
7.2.5 Inspecting the Waste Liquid Container / Tubing
A waste liquid container should be present next to the pure water bucket on the left side of
the analysis unit:
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 the SERVICE AGENT company.
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.
203
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 Primary Purified Water Filter
Figure 7-6: Removing the Pure Water Sensor
Figure 7-7: Removing the Stage I Filter
204
Figure 7-6: Replacing the Stage I Filter
Notes:
When installing the stage I filter, it is important to ensure that the filter and
the pure 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 pure water bucket and remove the stage I filter,
as shown in Figure s 7-8, 7-9, and 7-10;
Check that the stage I filter to be placed in the pure water bucket is completely clean.
If it is dirty:
First rinse off the stage I filter thoroughly in tap water then rinse once again using purified
water until completely clean;
Connect the stage I filter to the connecting tubing and place it in the clean water bucket;
7.3.2. 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
205
gauze to wipe the interior dry as shown in the following Figure :
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 stirring rod from the cleaning position;
5) Use a cotton swab dipped in cleaning solution to gently wipe the interior of the
stirring rod cleaning pool until no stains are visible, then wipe the surface dry with
clean gauze;
6) Move the Sample probe and stirring rod to the tops of the corresponding cleaning
206
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:
4) Hold both sides of the reaction disk with both hands and apply a uniform upward
force to remove the reaction plate, as shown below:
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:
207
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) Remove the stirring rod 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. Then apply lubricant oil to the rod and
pull up and down on the driving rod such that the lubricant is evenly distributed
along the driving rod;
4) Use the same method to wipe the Sample probe driving rod;
5) Move the Sample probe and stirring rod to the tops of the corresponding cleaning
pools.
7.4.4 Cleaning the Dust Filter

The dust filter should be cleaned in the following order:
2) Remove the dust filter from the bottom of the instrument.
3) Use pure water to rinse out the dust filter.
4) Air dry the dust filter and reinstall the dust filter into the instrument using the
same method.
7.5. Semi-Annual Maintenance
7.5.1. Replacing the Primary Stage Filter

The method for replacing the primary stage filter is the same as the method described in
208
Section 7.3.2.
7.5.2 Replacing the Second Stage Filter

When the second stage filter is obviously dirty or the amount of clean water on the interior is
obviously reduced, the second stage 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 second stage 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:
209
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:
210
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:
211
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
7.6.3. Replacing the Stirring Rod

In the event that the stirring rod 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 stirring rod to the appropriate position;
3) Loosen the two top wire screws fixed to the stirring motor shaft, as shown below:
212
4) Remove the stirring rod.
5) Install the new stirring rod upward in the motor shaft until you meet with resistance;
6) Use two top wire screws to fix the stirring rod onto the stirring motor shaft;

The stirring rod should be considered a source of contagion and gloves
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, manually or with a flathead screwdriver, unscrew
the fixing screws on either side of the lamp base, as shown below:
213
4) After removing the lamp, unscrew the two banana terminals shown in the Figure
below and remove the lamp power cord, as shown below:
5) Remove the old lamp, as shown below:
6) Insert the new lamp, apply the fixing screws and tighten the lamp power cord to the
two banana terminals;
7) Put the reaction disk back into place and apply the fixing screws;
8) Place the cover on the reaction disk.
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.
214
7.7. Replaceable Device List
7.7.1. The following is a list of items that can be replaced

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

1) The SERVICE AGENT 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 SERVICE AGENT
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 devices.
215
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 Record
Maintenance
1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 3 3
Performed (Daily) 1 2 3 4 5 6 7 8 9
0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1
Wiping Down of
the Analyzer
Countertop
Cleaning of the
Sample probe /
Stirring Rod
Inspection of the
Reagent / Sample
Syringe
Inspection of the
Purified Water
Bucket
Inspection of the
Waste Liquid
Container / Tubing
Maintenance Maintenance Record
Performed
(Weekly)
216 SERVICE AGENT Manual

Cleaning of the
Pure Water Filter
Cleaning of the
Waste Liquid
Container
Cleaning of
the Reagent /
Sample disk
Refrigeration Unit

Performed
(Monthly)
Cleaning of the
Cleaning Pool
Cleaning of the
Reaction
Compartment
Wiping the of
Driving Rod
Cleaning of the
Dust Filter
SERVICE AGENT Manual 217


Performed
(Semi-Annually)
Cleaning of the
1
Cleaning Pool
Cleaning of the
Reaction
2
Compartment
Wiping of the
3
Driving Rod
Cleaning of the
Dust Filter
Performed
(Unscheduled)
Unblocking of
the1 Sample /
Reagent probes
Replacement of
the2 Sample /
Reagent probes
Replacement of
the3 Stirring Rod
Replacement of
the4 Lamp
Replacement of
the5 Syringe
Replacement of
the6 Stage II Filter
218 SERVICE AGENT Manual

8. Alarm Information and Processing
8.1. Overview ................................................................................................................. 220

8.2 Alarm Information Inquiry ..................................................................................... 220
8.2.1. Error Code Definition..................................................................................... 220
8.2.1.1. Error Level Code Definitions .................................................... 220
8.2.1.2. Host Machine Code Module Definitions ................................. 221
8.2.1.3 Slave Machine Unit Code Definitions...................................... 221
8.2.2 Instrument Runtime Error Table................................................................... 221
219
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 SERVICE AGENT.
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 SERVICE AGENT Auto Chemistry Analyzer runtime errors
are summarized below:
8.2.1. Error Code Definition
Error Class Code Error Code

Host Machine Module Code Slave Machine Unit 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.
220
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 Definition

Code
00 Main control unit
01 ISE unit
8.2.2 Instrument Runtime Error Table

Leve
Error Code Description Solution
l
1. Turn on the system power;
Cycle command 2. Check the cable and restart the
ERR1100001 ERR system. If the problem persists, please
response timeout
contact SERVICE AGENT's technical
support department.
Cycle command If the system receives abnormal data,
ERR1100002 ERR results frame data please contact the SERVICE AGENT
abnormal technical support department.
Temperature query If the system receives abnormal data,
ERR1100003 ERR results frame data please contact the SERVICE AGENT
abnormal technical support department.
If the system receives abnormal data,
Abnormality in pre-compiler
EXC1100004 FAT please contact the SERVICE AGENT
cycle command
technical support department.
Unit error during
EXC1100005 FAT Execute a cycle recovery command
cycle test
A unit of the recovery cycle
has malfunctioned, but Wait until the test completes, exit the
EXC1100006 FAT tests for which samples host computer and perform a restart.
have already been loaded Then, perform a power on self-test
can continue to completion
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
221
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
SERVICE AGENT 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 SERVICE AGENT'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
SERVICE AGENT'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 SERVICE
AGENT's technical support
department.
If the system receives abnormal data,
Cycle command results
ERR1101010 ERR please contact the SERVICE AGENT
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 SERVICE
AGENT technical support 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
is misplaced;
ERR1101012 ERR Sample probe collision
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 SERVICE
222
department.

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
reoccurs, please contact the
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
SERVICE AGENT'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 SERVICE AGENT's technical
insufficient support 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
contact SERVICE AGENT's
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
please contact SERVICE AGENT's
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
223
Sample probe was not in the SERVICE AGENT technical
the initial vertical position. support 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
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 SERVICE AGENT technical support
224
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
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
225

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,
department.
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
ERR1101034 ERR Turn on pump error
Turn on pump and close check the guidewire and valve and
ERR1101035 ERR
solenoid valve error reboot the machine. If the error
There were errors when
ERR1101036 ERR closing the pump and
solenoid valve
ERR1101037 ERR Turn Off error photo or electromagnetic interference,
226

ERR1101038 ERR Turn off pump error
Sample probe error when
ERR1101039 ERR opening the cleaning
valve on the inner wall
ERR1101040 ERR Syringe is out of step
1) Perform a check after shutting
down the machine and fix the
serial cable in place;
Sample probe unit 2) Eliminate strong electromagnetic
ERR1101042 ERR command reception interference, reboot the system. If
efficacy and error the problem continues to reoccur,
department.
The Sample probe has Add additional sample. If the
detected that the problem continues to reoccur,
ERR1101043 ERR
amount of sample is please contact SERVICE AGENT'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
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.
227
The syringe has moved to
ERR1101047 ERR the initial vertical position
too early
Sample syringe unable to
ERR1101048 ERR leave initial vertical
position error
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
Add S position
ERR1101053 ERR rotating to acid-base
cleaning position
ERR1101054 ERR
rotating to ISE position sensor wires are not disconnected and
During an online dilution, Add additional sample. If the
the sample probe problem continues to reoccur,
ERR1101055 ERR
detected an insufficient please contact SERVICE AGENT's
amount of sample technical support department.
228
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
Clockwise rotation error and check that the sensor plug is not
when performing a loose. If it is not loose, check that the
ERR1101057 ERR
sample probe initial sensor wires are not disconnected and
position reset restart the machine. If the error
Insufficient sample in Please contact the SERVICE
ERR1101058 ERR cuvette during online AGENT technical support
dilution department.
Reagent disk unit 2) Eliminate strong
ERR1101110 ERR command reception electromagnetic interference,
efficacy and error then reboot the system. If the
department.
Please contact the SERVICE
Vacuum pump turn off
ERR1101113 ERR AGENT technical support
error
department.
Vacuum pump turn on
error
department.
Encoding disk error when
ERR1101115 ERR reagent sample disk is
rotating
Initial position sensor and check that the sensor plug is not
ERR1101116 ERR error when reagent loose. If it is not loose, check that the
sample disk is rotating sensor wires are not disconnected and
229
230
There was an error with and check that the sensor plug is not
the reagent disk when loose. If it is not loose, check that the
ERR1101118 ERR
rotating to specified sensor wires are not disconnected and
sample position restart the machine. If the error
Reagent disk error when electromagnetic interference factors
rotating to initial position and check that the sensor plug is not
or when passing through loose. If it is not loose, check that the
ERR1101119 ERR
the initial position when sensor wires are not disconnected and
rotating to a specified restart the machine. If the error
cuvette reoccurs, please contact the SERVICE
ERR1101120 ERR Mixer vertical reset error
Mixer unable to leave
ERR1101121 ERR initial vertical position
error
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
ERR1101124 ERR Mixing motor turn off error
231
Pump turn off error photo or electromagnetic interference,
(cleaning of the outer check the guidewire and board and
ERR1101125 ERR
wall of the stirring rod reboot the machine. If the error
was stopped) reoccurs, please contact the SERVICE
Error when closing the
cleaning valve on the
ERR1101126 ERR outer wall of the mixer
and turning off the
mixing motor
Pump turn on error
ERR1101127 ERR (cleaning the outer wall of
the stirring rod)
Error when opening the
cleaning valve on the
ERR1101128 ERR outer wall of the mixer
and turning on the mixing
motor
Initial position not found and check that the sensor plug is not
error when performing a loose. If it is not loose, check that the
ERR1101129 ERR
mixer horizontal rotation sensor wires are not disconnected and
reset restart the machine. If the error
Mixer not left initial and check that the sensor plug is not
position error when loose. If it is not loose, check that the
ERR1101130 ERR
performing a horizontal sensor wires are not disconnected and
rotation reset restart the machine. If the error
Mixer error when rotating loose. If it is not loose, check that the
ERR1101131 ERR
to cleaning position sensor wires are not disconnected and
232
Mixer error when rotating and check that the sensor plug is not
to cleaning position loose. If it is not loose, check that the
ERR1101132 ERR
during deceleration sensor wires are not disconnected and
interval restart the machine. If the error
Mixer error when rotating loose. If it is not loose, check that the
ERR1101133 ERR
to reaction disk position sensor wires are not disconnected and
Mixer error when rotating and check that the sensor plug is not
to reaction disk position loose. If it is not loose, check that the
ERR1101134 ERR
during deceleration sensor wires are not disconnected and
interval restart the machine. If the error
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 stirring rod vertical
reset command, check the wiring
and connectors, and then re-execute
Mixer rotation prohibited
ERR1101137 ERR the corresponding rotate command.
alert
If the error reoccurs, please contact
the SERVICE AGENT technical
support department.
Mixer unit command 2) Eliminate strong
ERR1101143 ERR reception efficacy and electromagnetic interference,
error then reboot the system. If the
department.
233
First perform a cleaning nozzle
vertical reset command, check the
wiring and connectors, and then
Reaction disk rotation re-execute the corresponding rotate
ERR1101153 ERR
prohibited alert command. If the error reoccurs,
please contact the SERVICE
AGENT technical support
department.
Reaction disk command 2) Eliminate strong
ERR1101154 ERR reception efficacy and electromagnetic interference,
error or invalid command then reboot the system. If the
department.
Cuvette encoding disk loose. If it is not loose, check that the
ERR1101155 ERR
error sensor wires are not disconnected and
Reaction disk initial loose. If it is not loose, check that the
ERR1101156 ERR
position not found error sensor wires are not disconnected and
Cuvette encoding disk
ERR1101157 ERR error during deceleration
interval
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
the problem continues to reoccur,
Incorrect Sample channel Please enter the correct Sample
ERR1101159 ERR
no. channel number.
234
Cleaning solution valve
opening error
department.
Cleaning solution valve
closing error
department.
ERR1101162 ERR Vacuum valve opening error AGENT technical support
department.
ERR1101163 ERR Vacuum valve closing error AGENT technical support
department.
ERR1101164 ERR Waste valve opening error AGENT technical support
department.
ERR1101165 ERR Waste valve closing error AGENT technical support
department.
Initial position sensor
error or motor step loss
ERR1101166 ERR when performing a
vertical reset operation on
the cleaning head
The cleaning head and check that the sensor plug is not
reaches the initial position loose. If it is not loose, check that the
ERR1101167 ERR
while moving up 185 sensor wires are not disconnected and
steps restart the machine. If the error
Cleaning head has not left loose. If it is not loose, check that the
ERR1101168 ERR
the initial position sensor wires are not disconnected and
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
235
Perform a cleaning head vertical
reset, move the cleaning head into
the waste liquid suction position and
Cleaning head moves into
ERR1101170 ERR re-execute this operation. If the error
the initial position early
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 re-execute the operation. If the
ERR1101172 ERR
reset error problem persists, please contact the
SERVICE AGENT technical
department.
ERR1101173 ERR Pump turn on error AGENT technical support
department.
ERR1101174 ERR Pump turn off error AGENT technical support
department.
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 SERVICE AGENT'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
ERR1101214 ERR Cooling fan turn on error persists, please contact SERVICE
236
department.
Immediately contact the SERVICE

ERR1101215 ERR Cooling fan turn off error AGENT technical support
department.
Immediately contact the SERVICE
ERR1101216 ERR High temperature alarm AGENT technical support
department.
237
Temperature control unit 2) Eliminate strong
ERR1101236 ERR command reception electromagnetic interference,
department.
2) Eliminate strong
ERR1101239 ERR Incorrect channel no. electromagnetic interference,
then reboot the system. If the
department.
2) Eliminate strong
Main control unit command electromagnetic interference,
ERR1101244 ERR
department.
Perform a malfunction recovery
command. If the problem continues to
Main control unit control
ERR1101252 ERR reoccur, please contact SERVICE
error
department.
1) Turn on the system lamp
Optical data returned by 2) Please contact the SERVICE
WAR2100001 WAR
all channels is zero. AGENT 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 SERVICE
department.
The channel background each channel to within the
WAR2100003 WAR value is lower than the standard range;
alarm value
2) Replace the lamp;
238
3) Please contact the SERVICE
department.
239
each channel to within the
The channel background standard range;
WAR2100004 WAR value is lower than the 2) Replace the lamp;
warning value 3) Please contact the SERVICE
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 SERVICE
current configuration
AGENT 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}] SERVICE AGENT technical support.
Deionized water level is

WAR3200611 WAR low. disk No.: {0}, Cuvette Add deionized water
No.: {1}
1) The host machine must inject

70 uL of sample to increase the
sample size;
Air is present in the 2) The operator must put an
ISES000000 ISE
sample adequate amount of sample in
the sample cuvette;
3) If the electrode is not installed
properly, reinstall it;
240
4) Replace the tube;
241
1) The electrode is not properly
installed. Check the plate
springs, seals, etc.;
2) Ensure that all electrodes and O
rings are correctly positioned;
3) Use the <CLEN > program to
clean the module;
4) Unpack the module, clean it and
reinstall the sensor;
Air is present in
ISEA000000 ISE 5) Replace the bubble detection
Calibrator A
sensor; Replace the waste
liquid pump;
6) Replace Calibrator A, and
perform a recalibration;
7) Reconnect or replace the tubing;
8) Check the electrical connection;
Replace the pump cartridge;
9) Replace the motor; Replace
the tubing;
springs, seals, etc.;
2) Ensure that all electrodes and O
rings are correctly positioned;
Air is present in 3) Use the <CLEN > program to
ISEB000000 ISE
Calibrator B clean the module;
4) Unpack the module, clean it and
reinstall the sensor;
5) Replace the bubble detection
sensor; Replace the waste
liquid pump;
springs, seals, etc.; Ensure that
all electrodes and O rings are
correctly positioned;
2) Use the <CLEN > program to
ISEC000000 ISE Air in Wash solution clean the module; Unpack the
module, clean it and reinstall
the sensor;
3) Replace the bubble detection
sensor;
4) Replace the waste liquid pump;
Replace the reagent kit Check

ISEM000000 ISE No liquid in the flowline
the flowline
242
1) Ensure that there are no issues
with operation and add 100 ul
ISEP000000 ISE Pump calibration error saline;
2) Re-run the pump calibration;
Replace the reagent kit Check the

ISEF000000 ISE No liquid in the flowline
flowline connection
ISED000000 ISE Bubble detector error Replace the bubble detection sensor;
Failure reading the Install a reagent kit or replace the

ISER000000 ISE
reagent kit current reagent kit
Failure writing to the Install a reagent kit or replace the

ISEW000000 ISE
reagent kit current reagent kit
ISET000000 ISE Error executing command Contact the developer
1) Replace the Li electrode and

2) Check ambient conditions and
remove any sources of electrical
noise; Check whether or not the
ISE module is grounded and
Li electrode voltage ensure the ISE module is
ISE0100000 ISE
overflow error properly grounded;
3) Replace the board;
4) Remove the electrode and use
a wet paper towel to remove
any salts or liquids. Dry the
electrode and reinstall;
ISE0001000 ISE Li electrode noise error ensure the ISE module is
properly grounded;
243
1) Replace the Li electrode;
2) Perform a PurgA command, and
then recalibrate. If you have just
ISE0000010 ISE Li electrode drift error replaced the electrode with a
new one, wait 15 minutes for the
electrode to settle. After waiting
15 minutes, perform a
recalibration;
1) Remove the electrode, check
the electrode O-ring and
reinstall and recalibrate the
electrode;
2) Replace the reagent kit and
4) Move the electrode out of the
way, tap gently to remove air
Li electrode slope bubbles and reinstall and
ISE0000001 ISE
exceeds standard range recalibrate the electrode;
5) Replace the reference electrode
and perform a recalibration;
6) Replace the electrode and
7) Monitor the temperature. If the
ambient temperature is too high,
move the instrument to an area
with an ambient temperature
that satisfies the device's
temperature requirements.
1) Replace the Na electrode and
Na electrode voltage ensure the ISE module is
ISE0200000 ISE
244
ISE0002000 ISE Na electrode noise error ensure the ISE module is
properly grounded;
1) Replace the Na electrode;
2) Perform a PurgA command, and
then recalibrate. If you have just
ISE0000020 ISE Na electrode drift error replaced the electrode with a new
one, wait 15 minutes for the
electrode to settle. After waiting
15 minutes, perform a recalibration
1) Remove the electrode, check the
electrode O-ring and reinstall and
recalibrate the electrode;
bubbles and reinstall and
Na electrode slope
ISE0000002 ISE recalibrate the electrode;
exceeds standard range
1) Replace the K electrode and
K electrode voltage
ISE0400000 ISE noise; Check whether or not the
overflow error
ensure the ISE module is
properly grounded;
245
ISE0004000 ISE K electrode noise error ensure the ISE module is
properly grounded;
1) Replace the K electrode;
2) Perform a PurgA command,
and then recalibrate. If you have
ISE0000040 ISE K electrode drift error just replaced the electrode
with a new one, wait 15 minutes
for the electrode to settle.
After waiting 15 minutes,
K electrode slope
ISE0000004 ISE recalibrate the electrode;
exceeds standard range
246
1) Replace the Cl electrode and
Cl electrode voltage ensure the ISE module is
ISE0800000 ISE
1) Replace the CL electrode and
ISE0008000 ISE CL electrode noise error ensure the ISE module is
properly grounded;
1) Replace the CL electrode;
ISE0000080 ISE CL electrode drift error just replaced the electrode
3) Replace the CL electrode and
CL electrode slope 4) Move the electrode out of the
ISE0000008 ISE
exceeds standard range way, tap gently to remove air
247
and retest;
Total electrode voltage ensure the ISE module is
ISE0F00000 ISE
electrode and reinstall
and retest;
Total electrode ensure the ISE module is
ISE000F000 ISE
noise error properly grounded;
electrode and reinstall
ensure the ISE module is
properly grounded;
ISE00000F0 ISE Total electrode drift
just replaced the electrode
248
Appendix A
A.1. Common Terms ...................................................................................................... 250

A.1.1. AD Value ......................................................................................................... 250
A.1.2. Dark Current ................................................................................................... 250
A.1.3. Water Blank .................................................................................................... 250
A.1.4. Optical Metering Point................................................................................... 250
A.1.5. Absorbance .................................................................................................... 250
A.1.6. Reaction Curve .............................................................................................. 250
A.1.7. Reactivity ........................................................................................................ 251
A.1.8. Calibration ....................................................................................................... 251
A.1.9. Calibration Curve ........................................................................................... 251
A.1.10 Calibration Parameter ................................................................................... 251
A.2. Technical Parameters............................................................................................ 252
A.3. Power Requirements............................................................................................. 253
A.4. Operating Ambient Temperature and Humidity Requirements ....................... 253
A.5. Computer and Printer Configuration ................................................................... 253
A.6. Communication Interface...................................................................................... 254
A.7. Dimensions and Weight ........................................................................................ 254
A.8. Options .................................................................................................................... 254
A.9. Other ........................................................................................................................ 254
A.10. Transport and Storage Requirements ................................................................ 254
A.11. Safety Classifications ............................................................................................ 255
A.12. After-Sales Service ................................................................................................ 255
A.13. Warranty Service ................................................................................................... 255
249
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 pure 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.
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 60 optical metering points, and in high-speed mode
the time intervals between two adjacent optical metering points is 15 seconds; In standard
mode, the time interval between two adjacent optical metering points is 22.5 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 AD 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 15 seconds; In standard mode, a single cycle lasts 22.5 seconds.
250
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.
251
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 ≤0.003% (or absorbance ≥ 4.5)
Test Speed ≥ 225 tests / hour (excluding ISE); ≥ 300 tests / hour (including ISE);
Analysis Principle Can perform colorimetry, nephelometry, or ISE analyses

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
Longest Reaction
15min( single reagent); 12min (double reagents)
Time
40 sample positions, compatible with a variety of differently sized

Sample disk
miniature sample vials, original blood collection tubes, plastic tubes, etc.
Sample probe 1 probe which includes a liquid level sensor, volume tracking,
three-dimensional anti-collision protection and automatic cleaning
Sample Vol 2 ~ 50 ul in 0.1ul increments
functionality
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
Stirring Rod Independent stirring rod
Minimum reaction
150 μL
volume
252
81 semi-permanent Ultraviolet transmission rigid cuvettes, optional
Cuvettes
permanent quartz
glass cuvette,
Carryover
≤ 0.005%
6-pin 18-step self-cleaning
Contamination Rate
Solid thermostat, reaction disk temperature maintained at

Thermostat System
37 ± 0.1 °C, free routine maintenance
Light Source Halogen lamp, 12V / 20W, minimal current with high stability
8 wavelengths ranging from 340 - 800 nm (can chose either 800nm,
Wavelengths
700 nm or 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
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% RH
A.5. Computer and Printer Configuration
Computer CPU of 2.0 GHz or greater, more than 2.0 GB of RAM, preloaded
Configuration with the Windows 7 operating system;
Display Resolution;
Printer Supports laser, inkjet and dot matrix printers
253
A.6. Communication Interface
Communication Interface for Biochemical

RS-232 serial interface
Analyzer Host Machine and Computer
Interface for Computer and Printer /
USB interface
Handheld Barcode Scanner
Computer Network Interface Network port
A.7. Dimensions and Weight
Bare Dimensions (mm, length X depth

855X550X580
X height)
Bare Weight (kg) 100
A.8. Options
Pure water dispenser capable of dispensing ≥ 10L water / hour;

UPS: ≥ 30 minutes uptime;
Options
ISE module
Barcode module
A.9. Other
Overall water
< 3.5 L / h
consumption
Operating noise (dB) < 65
Total Power (VA) 350
A.10. Transport and Storage Requirements
Temperature 0°C - 40°C
Humidity Relative humidity of 30% - 90%, non-condensing.
254
A.11. Safety Classifications
Electric Shock
Class I externally-powered equipment
Prevention Class
Overvoltage Class Class II
Pollution Class Class 2
A.12. After-Sales Service
After-sales service is provided by authorized agent.
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 ;
5) Other damage caused by uncontrollable natural factors such as earthquakes, fires

or war.
255

GS300 User Manual PDF

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GS300 User Manual PDF

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Auto Chemistry Analyzer

Product Name: Auto Chemistry Analyzer.

Safety Classifications: Class Ⅱ Overvoltage, Pollution Grade 2.

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

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.

Product Serial Number

Protective Conductor Terminal

The product is an in vitro diagnostic device

OFF Power Off

Serial Port Communication Port

Waste Liquid Outlet Waste Liquid Outlet

Pure Water Inlet Pure Water Inlet

1. Safety and Precautions .................................................................. 11

3. Structure and Functions ............................................................. 32

4. Detailed Operating Procedure .................................................... 46

5. Simplified Operating Procedures ............................................. 153

6. Analysis Principles and Computational Methods................... 171

7. Care and Maintenance ............................................................... 197

8. Alarm Information and Processing .......................................... 219

Appendix A .......................................................................................... 249

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

1.1.7. 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 10 mΩ; poor grounding can

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

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

4) If use of the instrument is stopped due to malfunction and repairs or

2) Drugs, anticoagulants, preservatives, etc. which are present in a

3) Lipemia, jaundice and hemolytic samples may affect analysis results

4) Please store samples correctly. Incorrect sample storage conditions

5) In order to prevent sample evaporation, do not leave the sample open

6) There are requirements concerning sample volume when performing

7) Prior to analysis, make sure the sample is positioned correctly. Failure

1.2.13. Reagents, Calibrators and Control Fluids

3) For information concerning the use and storage of reagents,

4) If reagents, calibrators, or control liquids are improperly stored,

5) Please perform a calibration after replacing reagents. Failure to

7) Prior to analysis, make sure the sample is positioned correctly. Failure

1.2.15. Analysis Parameters

1.2.16. Data Backup

1.2.17. Disposing of the Instrument

When the analyzer needs to be relocated, please contact authorized agent.

2.2. Damage Inspections

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:

2.3.1. Environmental Requirements

Specification 5530 (mm);