URIT-8260 (R) UserManual

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Operating manual

CATALOGUE

COPYRIGHT AND DECLARATION..........................................................................................................................1

PREFACE......................................................................................................................................................................3

SAFETY GUIDELINES............................................................................................................................................... 5

USING PRECAUTION................................................................................................................................................ 8

CHAPTER 1 INSTRUMENT INTRODUCTION.................................................................................................... 12

1.1 BRIEF INTRODUCTION................................................................................................................................................12


1.2 INTENDED USE......................................................................................................................................................... 13
1.3 MAIN STRUCTURE.....................................................................................................................................................13
1.3.1 Front view.................................................................................................................................................... 13
1.3.2 Top view....................................................................................................................................................... 14
1.3.3 Rear view......................................................................................................................................................15
1.4 INSTRUMENT FUNCTION............................................................................................................................................ 16
1.5 TECHNICAL PARAMETER............................................................................................................................................. 18
1.6 INSTRUMENT MAIN STRUCTURE...................................................................................................................................19
1.6.1 Function of main part.................................................................................................................................. 19
1.6.2 Reaction system........................................................................................................................................... 20
1.6.3 Sample processing system........................................................................................................................... 21
1.6.4 Reagent processing system..........................................................................................................................24
1.6.5 Stirring system............................................................................................................................................. 26
1.6.6 Automatic cleaning mechanism.................................................................................................................. 26
1.6.7 Flow path system......................................................................................................................................... 28
1.6.8 Photo-electrical detecting system............................................................................................................... 28
1.7 OPTIONAL MODULES................................................................................................................................................ 29
1.7.1 ISE module................................................................................................................................................... 29
1.7.2 Sample barcode scanning system................................................................................................................29
1.7.3 Reagent barcode scanning system.............................................................................................................. 29
1.8 OPERATION DEPARTMENT..........................................................................................................................................30

CHAPTER 2 INSTALLATION...................................................................................................................................31

2.1 INSTRUMENT INSPECTION.......................................................................................................................................... 31


2.2 INSTALLATION REQUIREMENT......................................................................................................................................31
2.2.1 Installment environment............................................................................................................................. 31

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Operating manual

2.2.2 Power requirements.................................................................................................................................... 32


2.2.3 Location requirements.................................................................................................................................33
2.3 INSTRUMENT CONNECTION........................................................................................................................................ 33
2.3.1 Connect the power line and communication line....................................................................................... 33
2.3.2 Connect the flow path................................................................................................................................. 34
2.3.3 Connect the printer......................................................................................................................................35

CHAPTER 3 SYSTEM SETTINGS.........................................................................................................................36

3.1 SYSTEM MENU......................................................................................................................................................... 36


3.2 NORMAL ITEM PARAMETER SETTING............................................................................................................................ 37
3.2.1 Setting interface...........................................................................................................................................37
3.2.2 Reagent, Sample and Time Setup Interface................................................................................................ 40
3.2.3 Normal Value Range Interface.....................................................................................................................42
3.3 SPECIAL ITEM SETTING...............................................................................................................................................44
3.3.1 Special item parameter................................................................................................................................44
3.3.2 Calculated Item Setting................................................................................................................................45
3.3.3 Profile item setting.......................................................................................................................................47
3.4 CALIBRATION SETTING...............................................................................................................................................48
3.5 QC SETTING............................................................................................................................................................49
3.5.1 Added control solution lot number............................................................................................................. 50
3.5.2 Delete control solution lot number............................................................................................................. 50
3.6 SYSTEM PARAMETER SETTING......................................................................................................................................51
3.6.1 Communication port and hospital name setting........................................................................................ 51
3.6.2 Hospital information setting........................................................................................................................52
3.6.3 Diagram display color setting...................................................................................................................... 56
3.6.4 Lis connection setting.................................................................................................................................. 56
3.6.5 Print setting..................................................................................................................................................56

CHAPTER 4 BASIC OPERATION..........................................................................................................................57

4.1 OPERATION PROCEDURES.......................................................................................................................................... 57


4.2 CHECK BEFORE POWERING ON.................................................................................................................................... 58
4.3 STARTING UP...........................................................................................................................................................60
4.3.1 Turn on the instrument................................................................................................................................60
4.3.2 Start the operating software....................................................................................................................... 61
4.3.3 Confirm the instrument status.................................................................................................................... 63
4.3.4 Confirmation the reagent status................................................................................................................. 63

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4.4 PRE-TEST PREPARATION............................................................................................................................................. 64


4.4.1 Prepare the biochemical reagent................................................................................................................ 64
4.4.2 Prepare the detergent................................................................................................................................. 65
4.5 CALIBRATION TEST.................................................................................................................................................... 66
4.5.1 Prepare the calibration solution.................................................................................................................. 66
4.5.2 Application for the calibration test..............................................................................................................67
4.5.3 Start the calibration test.............................................................................................................................. 68
4.6 QC TEST................................................................................................................................................................. 68
4.6.1 Prepare the control solution........................................................................................................................68
4.6.2 Application for the QC test.......................................................................................................................... 69
4.6.3 Start the QC test...........................................................................................................................................69
4.7 ROUTINE SAMPLE TEST.............................................................................................................................................. 69
4.7.1 Prepare the sample......................................................................................................................................70
4.7.2 Application for the routine sample test...................................................................................................... 70
4.7.3 Start the sample analysis............................................................................................................................. 73
4.8 EMERGENCY SAMPLE TEST......................................................................................................................................... 74
4.8.1 Application for the emergency sample test................................................................................................ 75
4.8.2 Start the emergency sample test.................................................................................................................77
4.9 SPECIAL SAMPLE TEST................................................................................................................................................77
4.9.1 Sample Complementing Test....................................................................................................................... 77
4.9.2 Re-test the sample....................................................................................................................................... 78
4.9.3 Sample dilution test..................................................................................................................................... 83
4.10 TEST STATUS AND STOP............................................................................................................................................84
4.10.1 Check the test status..................................................................................................................................85
4.10.2 Pause operation......................................................................................................................................... 88
4.10.3 Exit..............................................................................................................................................................88
4.10.4 Emergency exit...........................................................................................................................................89
4.11 ROUTINE MAINTENANCE..........................................................................................................................................89
4.12 POWER OFF...........................................................................................................................................................90
4.12.1 Power off....................................................................................................................................................90
4.12.2 24 hours standby....................................................................................................................................... 91
4.12.3 Operation after Power Off......................................................................................................................... 91

CHAPTER 5 OPERATING PRINICPLE.................................................................................................................92

5.1 PRINCIPLE...............................................................................................................................................................93
5.2 TEST METHODS........................................................................................................................................................ 94

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5.2.1 Endpoint method......................................................................................................................................... 94


5.2.2 2-Point endpoint method............................................................................................................................ 96
5.2.3 Two point-speed method (fixed-time method)...........................................................................................97
5.2.4 Rate method (kinetic method).................................................................................................................... 99
5.3 CALIBRATION.........................................................................................................................................................101
5.3.1 Introduction............................................................................................................................................... 101
5.3.2 Liner calibration......................................................................................................................................... 102
5.3.3 Nonlinear calibration................................................................................................................................. 105
5.4 QUALITY CONTROL JUDGMENT METHOD.....................................................................................................................108
5.4.1 Introduction............................................................................................................................................... 108
5.4.2 Levey-jennings method..............................................................................................................................108
5.4.3Westgard method....................................................................................................................................... 108
5.4.4 Quality control judgment precautions...................................................................................................... 112

CHAPTER 6 DATA PROCESSING.......................................................................................................................114

6.1 CHECK THE CALIBRATION RESULT.............................................................................................................................. 114


6.1.1 Check the calibration curve....................................................................................................................... 114
6.1.2 Check the reaction curve........................................................................................................................... 115
6.1.3 Edit the calibration result.......................................................................................................................... 117
6.2 CHECK THE QC RESULT........................................................................................................................................... 118
6.2.1 Daily QC Data............................................................................................................................................. 118
6.2.2 Check the QC Curve................................................................................................................................... 119
6.2.3 Check the reaction curve........................................................................................................................... 120
6.2.4 Edit the QC Result...................................................................................................................................... 121
6.3 VIEW AND HANDLE THE SAMPLE RESULT.................................................................................................................... 122
6.3.1 Patient information registration................................................................................................................ 122
6.3.2 Check the reaction curve........................................................................................................................... 124
6.3.3 Result query............................................................................................................................................... 125
6.3.4 Result edit/modify..................................................................................................................................... 129
6.4 DATABASE MAINTENANCE........................................................................................................................................ 131
6.4.1 Database backup........................................................................................................................................131
6.4.2 Database restore........................................................................................................................................132
6.4.3 Automatic backup......................................................................................................................................132
6.5 PRINT TEST RESULT................................................................................................................................................. 133
6.5.1 Item print order setting............................................................................................................................. 133
6.5.2 Print QC Result........................................................................................................................................... 135

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6.5.3 Print Sample Report...................................................................................................................................137

CHAPTER 7 ADVANCED SETTINGS................................................................................................................. 141

7.1 BLANK SETTING......................................................................................................................................................141


7.1.1 Introduction............................................................................................................................................... 141
7.1.2 Blank setting...............................................................................................................................................142
7.2 SUBSTRATE EXHAUSTION JUDGMENT METHOD.............................................................................................................145
7.2.1 Introduction............................................................................................................................................... 145
7.2.2 Substrate exhaustion judgment method 1(absorbance limit)..................................................................146
7.2.3 Substrate exhaustion judgment method 2(Slope ratio)............................................................................147
7.3 LIS SETTING.......................................................................................................................................................... 149
7.3.1 Introduction............................................................................................................................................... 149
7.3.2 LIS communication parameter setting...................................................................................................... 149
7.3.3 Send test result to LIS................................................................................................................................ 152
7.3.4 Download the sample application information........................................................................................ 153
7.4 CUSTOM PRINT SETTING.......................................................................................................................................... 155
7.4.1 Introduction............................................................................................................................................... 155
7.4.2 Template management..............................................................................................................................156
7.4.3 Print ID dictionary setting..........................................................................................................................158

CHAPTER 8 QUALITY CONTROL ANALYSES AND CALIBRATION........................................................... 159

8.1 GENERAL INFORMATION..........................................................................................................................................159


8.2 QUALITY CONTROL..................................................................................................................................................159
8.2.1 Type of quality control materials...............................................................................................................159
8.2.2 Use and storage......................................................................................................................................... 159
8.2.3 Setup of target value, SD and control Limit...............................................................................................160
8.3 CALIBRATION.........................................................................................................................................................160
8.4 REASONS OF RANDOM ERROR.................................................................................................................................. 161
8.5 REASON OF SYSTEMATIC ERROR.................................................................................................................................161
8.6 HOW TO DEAL WITH OUT-OF-CONTROL......................................................................................................................162

CHAPTER 9 CARE AND MAINTENANCE......................................................................................................... 163

9.1 MAINTENANCE EQUIPMENT AND TOOLS..................................................................................................................... 164


9.2 INSTRUMENT MAINTENANCE INSTRUCTIONS................................................................................................................ 165
9.2.1 Probe and Stirrer Cleaning.........................................................................................................................165
9.2.2 Cuvette cleaning........................................................................................................................................ 166
9.2.3 Cuvette signal reading (Cuvette blank)...................................................................................................167

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9.2.4 A/D signal reading......................................................................................................................................169


9.2.5 Instrument status query............................................................................................................................ 170
9.2.6 Temperature check.................................................................................................................................... 171
9.2.7 Barcode scanning....................................................................................................................................... 172
9.3 DAILY MAINTENANCE.............................................................................................................................................. 175
9.3.1 Check the distilled water bucket............................................................................................................... 175
9.3.2 Check the Detergent Bucket...................................................................................................................... 176
9.3.3 Check the waste solution bucket...............................................................................................................177
9.3.4 Check the Detergent and Diluent solution in Sample Tray, Reagent Tray.................................................179
9.3.5 Check/Clean the Sample Adding Probe, Stirrer........................................................................................ 179
9.3.6 Check the Printer/Printing Paper...............................................................................................................180
9.4 WEEKLY MAINTENANCE.......................................................................................................................................... 180
9.4.1 Clean the Sample Add Probe..................................................................................................................... 180
9.4.2 Clean washing pool............................................................................................................................... 182
9.4.3 clean washing station................................................................................................................................ 184
9.4.4 Clean the Reagent Tray/Sample Tray.........................................................................................................185
9.4.5 Clean the Reaction Tray............................................................................................................................. 186
9.4.6 Clean the panel of instrument...................................................................................................................187
9.4.7 Deep clear the Cuvette.............................................................................................................................. 187
9.4.8 check the A/D value of cuvette................................................................................................................. 188
9.5 MONTHLY MAINTENANCE....................................................................................................................................... 190
9.5.1 Clean the Distilled Water Bucket............................................................................................................... 190
9.5.2 Clean the Detergent Bucket.......................................................................................................................191
9.5.3 Clean the Waste Solution Bucket.............................................................................................................. 193
9.5.4 Clean the Sample adding probe actuating shaft....................................................................................... 195
9.5.5 Clean the Stirrer Actuating Shaft...............................................................................................................195
9.5.6 Clean the cleaning mechanism..................................................................................................................196
9.6 NON-SCHEDULED MAINTENANCE............................................................................................................................. 197
9.6.1 Replace the cuvette................................................................................................................................... 197
9.6.2 Unclog the Sample Probe.......................................................................................................................... 199
9.6.3 Unclog the Reagent Probe......................................................................................................................... 199
9.6.4 Replace the light source lamp................................................................................................................... 206
9.7 PREVENTIVE MAINTENANCE..................................................................................................................................... 207
9.8 HANDLING FOR LONG TIME POWER OFF................................................................................................................... 207

CHAPTER 10 STORAGE AND TRANSPORTATION........................................................................................208

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10.1 STORAGE............................................................................................................................................................ 208


10.2 TRANSPORTATION.................................................................................................................................................208

CHAPTER 11 ALARM AND TROUBLESHOOTING..........................................................................................209

11.1 TROUBLESHOOTING GUIDE.................................................................................................................................... 209


11.2 OBTAINING TECHNICAL HELP..................................................................................................................................210
11.3 TROUBLESHOOTING METHOD................................................................................................................................ 210
11.4 TEST RESULT DATA ALARM......................................................................................................................................215

APPENDIX A REPLACEABLE COMPONENT...................................................................................................218

APPENDIX B BIOCHEMICAL TEST ITEMS LIST..............................................................................................219

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Operating manual

Copyright and Declaration


Copyright: URIT Medical Electronic Co., Ltd.

Thank you very much for your purchase of the URIT Automatic Chemistry Analyzer.

All contents of this manual are complied with the related laws and regulations of the People’s
Republic of China, as well as the specific conditions of the URIT Automatic Chemistry Analyzer. All
the updated information is included in this manual before printing. URIT is fully responsible for the
revision and explanation of this manual, and reserves the right to renovate the relevant contents
without separate notice. Some of the schematic pictures in this manual are for reference, if there is
any difference, please according to the real object.

All the information of this manual is protected by the Copyright Law. No part of this manual may be
reproduced, stored or transmitted in any form, or by any means without the express written
permission of URIT.

All instructions must be followed strictly during operation. In no event should URIT be responsible for
failures, errors and other liabilities resulting from user's noncompliance with the procedures and
precautions described in this manual.

Guarantee of limited quality liability: The Operating Manual of URIT Automatic Chemistry Analyzer
has been clearly shown the guarantee of quality liability between URIT and users, rights and duties in
the after sale service and starting and ending of the agreement.

If a malfunction occurred under normal use because of the material and workmanship, URIT will
provide one year’s warranty service from the date of installation to this instrument which sold by
URIT and agents. The using period of this instrument is 10 years.

Once the following situations occurred, URIT assumes no liability to the safety, reliability and
operation condition of the instrument, and all agreed right of free service is deem to be waived
permanently and unconditionally.

 Instrument under improper use or not by maintenance or has been damaged.


 Using the reagents and accessories not supplied or approval by URIT.
 Instrument damage caused by false operation or negligence because of user or others operates
the instrument not comply with this manual.
 Replace accessories not specified by URIT, maintaining, repairing by a personnel who does not
authorized by URIT.
 Components are discounted, drawing and readjusted not approved by URIT.
NOTE
URIT makes no warranties, either expresses or implied, as to product quality,
performance, and value as a commodity or applicability for any particular purpose.

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Operating manual

URIT Medical Electronic Co., Ltd.


Add: No.D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China

Tel: +86(773)2288586
Fax: +86(773)2288560
Web: www.urit.com
E-mail: [email protected]

Supplied by:
URIT Medical Electronic Co., Ltd.

Wellkang Ltd (www.CE-marking.eu)


16 Castle St, Dover, CT16 1PW, UK

Version:07/2018

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Operating manual

PREFACE

This document is the operating manual for URIT Automatic Chemistry Analyzer. It describes the
structure, operation, maintenance and troubleshooting concerning the instrument in details.

Users should read carefully the manual and get special training before operating to guarantee
instrument precision, normal operation and personal safety. All the figures provided in this manual
are for reference, if there is any difference, please according to the real object.

Please see the wooden case label for instrument production date.

Instrument service life is ten years.

Safety symbol

Following are the safety symbols which used together with character in the manual.

Marking Meaning

Operator should operate under the manual otherwise serious injury maybe
caused or even lost life. Serious injury involving go blind, trauma, burn
Warning
(excess temperature), electric shock, cataclasis, toxication and other
sequela.

System damage or incorrect result may cause if not comply with the manual
Caution
to operate.

Following the manual to avoid personal injury, physics damage and a series
of adverse impact on test results. Also point out source of infection. Personal
Note
injury involving mild burns, electric shock or drug allergy. Physical damage
involves damage to building, animal and pet.

Biohazard means the biological factor may be caused hazard to the


Biohazard
environment and organism.

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Operating manual

Sign illustration

Meaning of the signs used in Automatic Chemistry Analyzer is as following.

Caution. Refer to the


Caution. Electric shock
accompanying document

Caution. Hot surface Biohazard

Protective earthing Power on

In vitro diagnostic
Power off
medical device

Environmental protection Keep away from heat


lifetime and radioactive source

Serial number Manufacturer

May cause personal


Recovery
injury

Production date Service life

Refer to the operating


Put it up
manual

To be protected from rain Do not roll

Handle with Care Stacking layers limit

Laser radiation (for


barcode function)

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Operating manual

SAFETY GUIDELINES

Please comply with the following rules for safety and effective use. Any violation of the following
safety precautions is likely to cause personal injury or instrument damage.
Warning
If the operator does not follow the instructions given by URIT, then the protective measures
provided by this instrument may failure.

Prevent Breakage and Flammability


Please comply with the following precaution to prevent breakage.
Warning
1) Installation should be complied with installed instruction of the manual.
2) If relocation is necessary, contact your local distributor or URIT firstly.

Prevent Electric Shock


Please comply with the following precaution for preventing electric shock.
Warning
1) Users other than the servicing personal authorized by our company must not open the
rear cover and left/right cover when turn on the power.
2) If a spill occurs or liquid gets into the instrument, please contact URIT. Neglecting the
liquid may cause electric shock.

Prevent Personnel Injury


Please comply with the following precautions for preventing injury.
Warning
1) While the instrument is in motion, DO NOT touches the moving parts, such as
aspirating probe and stirrer, etc.
2) DO NOT put your finger or hand into the open part of instrument.

Eyes Protection
Please comply with the following precaution for eyes protection.
Warning
1) DO NOT directly look at the light emitting from the lamp source when the instrument is
in motion.
2) Turn off the power and wait for at least 15 minutes until the light source is cooling
before replacing light source to prevent scald.

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Operating manual

Precision and Accuracy of Data


Please attention to the following matters for getting the accurate data.
Note

1) DO NOT open the top cover, rear cover and reagent tray when the instrument is under
analyzing condition.
2) Please check the accuracy of instrument by quality-control before using.
3) Please comply with the manual to maintain, check and replace the assembly unit.
4) Please comply with the corresponding explanation to handle the reagent,
quality-control materials and reference materials.
5) Please handle the sample according to the requirements in the manual.

Chemical and Biological Safety


Please comply with the following matters for chemical and biological prevention.
Biological Hazard
Biological Hazard
If chemical adheres to the human body, contagion may occur. DO NOT touch the sample,
mixed solution and waste solution directly. Be sure to put on protective gloves, clothes, or
even goggles if necessary. If the sample splashes to the skin accidentally, please treat
immediately according to the working standards and consult a doctor.

Chemical Hazard
Warning
If chemical adheres to the human body, contagion may occur. DO NOT touch the sample,
mixed solution and waste solution directly. Be sure to put on protective gloves, clothes, or
even goggles if necessary. If the sample splashes to the skin accidentally, please treat
immediately according to the working standards and consult a doctor.

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Operating manual

The Preventive Warning of Electromagnetic Compatibility


Note
1) The instrument meets the requirements.
2) Before using the instrument, URIT suggests evaluate the electromagnetic
environment.

Note
1) Use the instrument in dry environment, especially there are artificial materials
(synthetic fabric carpet, etc.), may cause destructive electrostatic discharge, and lead
to wrong conclusions.
2) Do not use the instrument near the strong radiation sources, otherwise may interfere
with the instrument to work normally.

Waste Solution Disposal


Biological Hazard
1) Some substances contained in QC solution, standard solution and waste solution are
regulated by discharge standards and pollution control regulations, waste must be
disposed according to the relevant environmental protection regulations.
2) Be sure to put on protective gloves, clothes, or even goggles if necessary when
dispose waste solution.

System Dispose Hazards


Please comply with the following matters to dispose of the waste analyzer.
Warning
Materials of the analyzer are subject to contamination regulations. Dispose of the waste
analyzer in accordance with your local or national rule for waste disposal.

Fire and Explosion Hazards


Warning
Alcohol is flammable substance. Please exercise caution while using alcohol.

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Operating manual

Using Precaution

Please comply with the following rules for safety and effective use. Any violation of the following
precautions is likely to affect the accuracy and precision of the instrument.

Systematic Usage
Warning
1) Automatic Chemistry Analyzer is intended use for medical institution and laboratory to
analyze some specific chemical composition of human body fluid. If the instrument to
be used beyond this scope, consult URIT firstly.
2) Please consider together with the clinical symptom or other analyzing result when
make the clinical judgment.

Operator
Warning
The instrument is operated only by technicians, doctors and laboratory personnel that
trained by URIT.

Operational Environment
Caution
1) Please install the instrument according to the specified installed instruction in the
manual. Otherwise, the results may not reliable even may cause system damage.
2) Please contact URIT if system state is changed.

Caution on Electromagnetic Wave Interference


Caution
1) Keep the instrument away from strong noise source and electromagnetic wave. Turn
off mobile phones and transmitter-receiver when operating the instrument since the
electromagnetic wave may cause an adverse effect on instrument.
2) Do not use other medical instrument around the system that may generate
electromagnetic wave interfere with their operations.

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Operating manual

Indication for System Use


Caution
1) The operator must training before operating the instrument. Please follow the
instruction of manual to operate. Improper operation may cause personal injury, system
damage and improper result.
2) Please make a calibration and quality-control test before use the system for the first
time to ensure it can be used normally.
3) A quality-control test must be done when use the system. Otherwise, the reliability of
the result could not be guaranteed.
4) Do not open the sample/reagent cover while in the analyzing process.
5) The communication joint of analytical part is set to connect with the communication
joint of operational part. Please use the cables of URIT for connecting.
6) The operation part is an external computer which is installed the specified operational
software. The computer should be for the instrument exclusive use. DO NOT run any
other software when it is connected with the instrument. Inappropriate manner may
result in computer virus infection
7) DO NOT touch the keyboard, indicator and mouse when your hands is wet, also
includes the chemistry.

System Maintenance
Caution
1) Maintaining according to the instruction. Incorrect maintenance may lead to wrong
result even caused system damage and personal injury.
2) Dust may be there after long-time placement. Cleaning the surface by soft cloth or little
soap solution if necessary. Never use organic solvent such as alcohol. Wipe the
surface after cleaning.
3) Please turn off all the power supply and pull up the plug before cleaning. Take
measures to prevent water into the system, otherwise, will cause system damage or
personal injury.
4) Calibration analyses must be done when changed the light source, optical system,
sample needle, reagent needle, stirrer and any other major component.
5) Please turn off the power and wait the light is cooled down to avoid scald.

Setup of Parameters
Caution
To define such parameters as sample volume, reagent volume and wavelength, follow the
instructions in this manual and the instruction of reagents.

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Operating manual

Precaution for Handling Samples


Caution
1) Sample must not contain insoluble substances such as fibrin and dust. Coagulation and
impurity may block the aspirating probe thus causing bad effect on tests. Medicine,
anticoagulant, preservative exist in sample may influence test result, hemolytic, icterus
and chyle also will cause incorrect result. Suggest do background test.
2) Store the sample correctly. Sample structure will change and even caused incorrect
result in wrong storage.
3) DO NOT expose samples in the air for a long time because they may be contaminated
or boiled off and thus erroneous test result may occur.
4) Certain sample cannot be analyzed please contact reagent supplier for details.
5) Certain sample need to be preprocessed please contact reagent supplier or distributor.
6) Consult manual for sample volume when do the test.
7) Ensure sample positioned correctly before test, if not bad result may occur.

Handling Reagents, Calibration and Control


Caution
1) Proper reagent, calibration solution and control solution are needed for analyses.
2) Please choose correct reagent. Consult the manufacturer or distributor if uncertain
about the usage of reagent
3) For storage, handling and usage of reagent, standard solution and control serum, refer
to the Instruction for Use provided by their manufacturers. Improper storage may not
guarantee the accuracy of test result even though they are not expired.
4) Be sure to perform calibration when replacing reagent. Otherwise, inexact test result
may occur.
5) Cross-contamination among reagents may influence test results. Contact your reagent
supplier for details.

Data Back Up
Caution
Please backup the analysis data and measurement parameters regularly.

Contradication
Note
No contraindication for this product.

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Operating manual

Other Cautions
Caution
1) DO NOT touch the keyboard, indicator and mouse when your hands is wet, also
includes the chemistry.
2) Check samples for contamination (dust, or fibrinogen) and air bubble before analyses.
3) For replacements of major parts, such as light source lamp, aspirating probe, reaction
cuvette, etc., please contact URIT.
4) For settings of sample volume, reagent volume, wavelength, standard values, etc.,
please refer to the instruction in reagent kit as well as this operating manual. Checking
the quality of distilled water and detergent, check calibration results, control results,
and sample results after analyses. Make sure there is no air bubble in the flow paths.

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Operating manual

CHAPTER 1 INSTRUMENT INTRODUCTION

1.1 Brief introduction

Automatic chemistry analyzer is a clinical chemistry instrument with the characteristics of open,
full-automatic, discrete/optional, STAT priority and controlled by computer. It is intended for use in
conjunction with reagents to measure quantitatively certain chemical items in serum, urine and
cerebrospinal fluid. Please read the operating manual carefully before using since it is a high
sophisticated instrument.
Work Unit consists of optical unit, mechanical operation unit, liquid path control unit, hardware circuit
unit and operating unit.
1) Optical unit consists of 90 cuvettes, long lifetime halogen light and rear light-splitting optical
system.
2) The mechanical unit consists of sample processing system and reagent processing system,
which driven by constant current motor, to guarantee the stable operation. The sample
processing system includes sample tray, sample arm, sample syringe and sample probe
washing pool; reagent processing system includes reagent tray, reagent arm, reagent syringe
and reagent probe washing pool. The instrument also includes a unique stirring arm and
eight-step washing system.
3) The operating unit is an external computer

CPU: dual core frequency rate: 2.4 GHz or above.


Hard tray: 120G or above, recommend 500GB.
Memory: 2G or above, 4GB is recommended.
Resolution: 1024*768 or above, recommend 1440*900.
Net mouth (dual mouths is needed when connect Lis) and CD-ROM drive or USB port)
The application software should be setup under the Windows 7 or Windows XP
(Home/Professional SP3).
4) The liquid path control unit consists of vacuum pump, solenoid valve, syringe, rinse system and
pipeline system, etc. Using positive and negative pressure control system, precisely to control
the pressure, guarantee the stability of liquid path.
5) The hardware circuit unit consists of power board, main board, terminal board and transfer board,
etc.

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Operating manual

The instrument is easy to operate. The layout of the screen menu is reasonable, name is simple.
Such as testing parameter setup, patient’s information input, quality-control, reagent, data query,
standard, running test and hardware parameter. After setting, put the sample and reagent to the
instrument and begin to analyzing. Print out the result by the external printer at last.

1.2 Intended use

The instrument is applied for professional, in vitro use in hospitals, clinics and laboratories.

Caution

Some samples may not be analyzed according to the tested parameter and reagent. For
the case of these samples, please contact reagent manufacturer or distributor.

1.3 Main structure

1.3.1 Front view

Figure 1.3.1-2 Front view of Analysis Unit

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1.3.2 Top view

Washing
station

Reagent
Sample
adding
stirrer
mechanism

Reaction Reagent/Sa
tray mple tray

Reagent
stirrer Sample
adding
mechanism

Figure 1.3.2-2 Top View of Analytical Unit

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1.3.3 Rear view

Figure 1.3.3 Rear View of Analytical Unit

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1.4 Instrument function

1) System: Full-automatic, discrete/optional, STAT priority, with reset function.


2) Stand-by: 24 hours stand-by, auto-sleep and one key start-up function.
3) Rinse: Rinsing the inside and outside of aspirating probe (sample probe and reagent probe) with
constant-temperature distilled water, and omni directionally clean the stirrer; washing station of
eight-pin-ten-step rinse the cuvettes with detergent, and provides two paths detergent system,
separate rinse available among items.
4) Sample probe: With liquid level sensing, volume tracking function, has the stereo anti - collision,
automatic protection function. The automatic detection function (clot detection function) and the
air suction function .
5) Reagent probe: With liquid level sensing, volume tracking function, has the stereo anti - collision,
automatic protection function.Optional reagent needle preheating function and the automatic
detection function (clot detection function) and the air suction function .
6) Alarm: Alarm automatically when reagent, sample, distilled water or detergent is shortage and
waste solution is overfull; display reagent allowance and available tests number in real time; skip
the unqualified cuvette automatically; when the absorbance is out of range, the system will
alarm.
7) Backup reagent position: Three reagent positions available for the same item. When the first
alarm to lack of reagent occurs, aspirating probe will turn to the second reagent position to
aspirate reagent automatically, and the second alarm occurs, aspirating probe will turn to the
third reagent position to aspirate reagent.
8) Reagent capacity expansion: It’s provides the function that a reagent position can be set to test
several items.
9) Sample capacity expansion: Calibration or QC position can be opened as regular sample
position; and in the same way, regular sample position can be opened as calibration or QC
position.
10) Test method: End point, rate assay(kinetic method), 2-point end point, 2-point rate assay
(2-point kinetic method), dual-wavelength, blank method(reagent blank, sample blank and water
blank), immune turbidimetry, double reagent, electrode, colorimetric method , sample
appearance inspection (serum index, such as jaundice, hemolysis and lipid turbidity, etc.) ,
nonlinear detection, etc.
11) Calibration method: At least linearity (single point, two points, multi points) and non-linearity
calibration. Multiple calibration formula including Logit-Log4P, Logit-Log5P, exponential function,
spline, exponential 5P, parabola, Wei Bull, K factor method, etc.

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12) Calibration system: Selecting best test point according to reaction curve, not need to calibrate for
second time; Calibration time is select and result is calculated automatically. Tracking calibration
function, the change of K value is presented on a drawing. 8 calibrations in different
concentration can be used for each item.
13) QC rule: At least including westgard and levey-Jennings QC rules.
14) QC method: Real-time QC, within-day QC, between-days QC.
15) QC processing function: Predefine different controls. More than 4 controls can be tested
simultaneously and QC could be inserted randomly in the course of testing. QC diagram could
be stored, displayed and printed.
16) Colorimetric method: Colorimetric in reaction cup directly, and single-hole detection.
17) Monitor: Monitoring cuvette online, display whole reaction process in real time, skip and mark
the unqualified cuvette automatically.
18) Pre-diluents/Retest: The software could identify the sample which substrate is use up and
linearity is over range, for these samples, system could select pre-diluents test and retest
manually or automatically. The diluents time could be programmed. Max dilute multiple is up to
250.
19) Data reset: Reselect measure point against abnormal sample (Substrate use up, over range of
linearity) and recount without retest.
20) Enzyme linear verification and expanding function: Automatic verifies and searches the enzyme
linear reaction interval, and then obtains real results.
21) User mode: Hospital mode, blood station mode, physical examination center mode etc.
22) Item sequence: Item print and measuring sequence could be programmed.
23) Patient result and data storage: store and backup automatically and permanently in infinite
quantity.
24) Software management: Multilevel authority management to guarantee the security of
information.
25) Network: Data exchange between LIS and HIS automatically.
26) Barcode reader: The instrument supports the barcode scanning function. Supporting codabar,
interleaved 2of 5, code128, code39, code93, UPC/EAN and any other barcode rules.
27) Printing function: Various printing format, support Chinese/English printing. User could edit the
format of report.
28) Light source: Long-life halogen lamp, auto-sleep, cooling by wind.
29) Barcode Scanning: The instrument supports the barcode scanning function.
30) LIS/HIS: Support HL7 Protocol.
31) ISE: Support ISE Module.

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1.5 Technical parameter

1) Sample tray: 80 sample positions, they are consist of routine sample positions, standard
positions, quality control positions, probe washing position and STAT position; Various samples
can be put together, sample cups, neonate ultramicro quantity cup, primitive tube and plastic
tube is appropriate for those positions.
2) Reagent tray: 80 reagent positions (expandable), two specification bottles are available.
3) Cuvette: Holds 90 UV hardish cuvettes.
4) Optical system: Grating type rear spectrophotometry optical system with12 wavelengths (340nm,
405nm, 450nm, 480nm, 505nm, 546nm, 570nm, 605nm, 660nm, 700nm, 750nm, 800nm)
5) Absorbance range: -0.5~6.0, distinguish ability 0.0001.
6) Reagent refrigeration: 2℃~8℃.
7) Sample Volume per test: 2μL to 35μL, variable in 0.05μL.
8) Reagent Volume per test: 10μL to 300μL, variable in 0.5μL.
9) Reaction Volume: 100μL~600μL (light path is 5mm), 130μL~750μL (light path is 6mm),
150μL~900μL (light path is 7mm).
10) Reaction cup optical path: 5mm, 6mm and 7mm.
11) Light Source: 12V/20W, service life more than 2000 hours.
12) Power: 1100VA
13) Temperature Control: Solid direct heat thermostatic mode, 37℃±0.1℃.
14) Item storage: up to 1200.
15) Analyze item in the same time, for example to test 81 items, include 78 pieces of chemical item,
and 3 pieces of electrolyte item.
16) The test speed, maximum reaction time, water consumption and layout structure are shown in
the following table 1.1:
Table 1-1
Maximum
Water
Model Test speed reaction Layout structure
consumption
time
Constant speed:
Single reagent probe,
420 tests/h (pure
single sample probe,
biochemistry);
URIT-8260 9.3min ≤12 L/h double stirrers, single
Maximum speed:
reaction tray, single
600 tests/h (with
reagent sample tray
ISE,K+, Na+, Cl-)

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1.6 Instrument main structure

The analyzer is mainly consisting of analytical unit, computer and printer. The computer and printer
are optional accessories.
The analyzer is mainly used for analyze sample, measure the clinical chemical component in all
kinds of samples and generate the result data. The analyzer is mainly composed of the following
units:
1) Reaction system
2) Sample processing system
3) Reagent processing system
4) Stirring system
5) Automatic cleaning mechanism
6) Liquid path system
7) Photoelectric detection system
Computer winch has install the automatic biochemical analyzer operating software, is mainly used
for complete the test application, biochemical test, reaction process monitoring, calculate the results,
as well as the data input, storage and query, etc.
The printer is used for print the test results and other data.
The accessory kit of analyzer is contains the following related accessories: reagent bottles and liquid
pipe, etc.

1.6.1 Function of main part

1) Sample Tray: Convey sample cup to sample aspirating point and place cup.
2) Reagent Tray: Convey reagent to aspirating arm. The reagent tray with 24 hours non-stop
refrigeration function, and the temperature keep in the range of 2℃~8℃.
3) Reaction Tray: Fixed the cuvette. Sample and reagent reacted in the fixed cuvette in 37℃
thermostat meanwhile colorimetric directly.
4) Barcode scanning function (support): to identify the sample test tube and reagent bottle, and
coding for the tube and bottle.
5) ISE module (support): measuring the concentration of Na+ ion, K+ ion and Cl- ion of serum, blood
plasma and urine.
6) Sample aspirating mechanism: aspirating quantitative sample from sample cup and inject to
cuvette. The aspirating mechanism with liquid level sensing, volume tracking function,
auto-protective function to prevent from collision (optional function) and air suction
function(optional function).

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7) Reagent aspirating mechanism:aspirating quantitative volume of reagent from reagent bottle


and inject to cuvette; The aspirating mechanism with liquid level sensing, volume tracking
function, auto-protective function to prevent from collision (optional function) and air suction.
8) Stirring Mechanism: Stirs the reaction solution contained in reaction cuvettes.
9) Rinsing Mechanism: Drains out reaction solution and washes the cuvettes, Adding and drain out
the pure water. The design of eight pin and ten-step washing can clean the cuvettes adequately.
10) Stirrer Washing Pool: Omni directionally wash the stirrer.
11) Sample Probe Washing Pool: Omni directionally wash the inside and outside of sample probe by
distilled water.
12) Reagent Probe Washing Pool: Omni directionally wash the inside and outside of reagent probe
by distilled water.

1.6.2 Reaction system

Reaction system is made up of reaction tray and reaction cups. It is mainly used for loading reaction
cups, and provide appropriate and constant working environment for reaction solution of sample and
reagent; at the same time, according to the program control sequence to transfer the reaction cups to
the specified photoelectric data acquisition position to detect the signal for absorbance measurement.
Reaction cup is also a cuvette, colorimetric directly, single hole detection.
Warning
Reaction tray cover must be covered when the instrument is running. If you want to remove
or cover it, please wait after the sample adding stop moving.

1) Reaction tray
Reaction tray adopts the disc type physical design, contains 90 reaction cups. Reaction tray is doing
constant speed circular motion during the test; please add the sample, reagent or stirring when it
motionless. It is mainly used for loading reaction cups, and then transferring them to photoelectric
data acquisition position to measure the absorbance of reaction solution.

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1.6.2 Reaction tray


2) Reaction cup
Reaction cup is the place for sample and reagent undergo chemical reaction, also it used as a
cuvette. It is made by the hard material with good light-admitting quality (quartz cup is optional).
Supported reacting weight volume is 100μL~900μL. After each test, the reaction cup will be
eight-order cleaned and dried automatically, prepare for next test.

1.6.3 Sample processing system

Sample processing system is mainly used for loading samples, and then transfers each sample to
the sample absorbing position for absorb the sample, and then inject it to reaction cup where reacts
with reagent, and then measure the absorbance of reaction solution by optical detecting system.
The sample processing system includes sample tray, sample adding mechanism, sample probe
cleaning system and sample injection pump.
1) Sample tray
Warning
If you want to open the sample tray cover or adding sample, please make sure the
instrument is under standby mode or power off status, otherwise may damage the
instrument or cause personal injury.

Sample tray and reaction tray are located in the same tray, sample tray is outside, and inside is the
reagent tray. Sample tray is mainly used for loading sample cups (tubes) which contain sample,
standard solution or quality control material, and then transfer them to sample absorbing position,
and then wait for sample probe absorb the sample.

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◆ 62 Conventional sample position: 1 to 62


◆ 4 Emergency position: E1 to E4
◆ 8 Calibration position: S1 to S8
◆ 4 QC position: C1 to C6

Reagent tray
Sample tray

Figure 1.6.3-1 Reagent/sample tray


Users can put the diluted sample in any conventional sample position; sample tray allows set 20
virtual sample tray maximum, but only default one sample tray, it can edit 1320 samples at the same
time once; and support the newborn ultramicro sample cup, original blood collection tube, plastic
tube, etc.
Controlling button of sample tray
The controlling button is located on the lower right corner, which controls the tray to turn around.
When the indicator lamp of button is on, the sample tray will turn 1/3 cycle when press per time, and
now you can put or take out sample; if the indicator lamp is off, it is no avail to press the button.
 The indicator lamp is on: the system is free or in incubation state or the sample probe stop to
adding sample.
 The indicator lamp is off: the sample probe is adding sample.

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Controlling button

Figure 1.6.3-2 controlling button Figure 1.6.3-3 cover of sample tray

2)Sample adding mechanism


Sample adding mechanism has the function of absorb certain amount of sample from the sample cup
(tube), and then inject to the reaction cup. Sample adding mechanism is composed of sample probe,
sample probe rocker arm, sample probe drive shaft, sample syringe and corresponding flow path,
and it used for absorb certain amount of sample and then inject to the reaction cup, the same as
reagent adding mechanism, as shown in figure 1.6.3-2.

Figure 1.6.3-4 Reagent/sample adding mechanism

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Sample probe is mainly realize the basic function of absorb certain amount of sample and then inject
to the reaction cup, and the sample size is 2μL -35μL, increasing by 0.05μL. The sample probe also
has the following functions:
1) Liquid level sensing and volume tracking: Sample probe can automatically detect the liquid level
inside the sample cup, and according to absorb volume to determine the descending depth to
realize the volume tracking function.
2) Collision protection function: When sample probe contacts the obstacle, the anti-collision system
will be automatically started to prevent from collision, so as to protect the sample probe from
damage.
3) Probe-clog detected function(optional): Accurately test whether there has clot in sample,
whether there has clog in sample probe. If sample probe is clogged, the system warning will pop
up and continue to next sample adding operation.
Warning
Please do not put hands or other parts of the body in the path of rocker arm rotation or put
any obstacles in the rotary path when system is running, otherwise may cause personal
injury or damage to the system.

3)Sample probe cleaning system


Using constant temperature water to clean inner and outer wall, inner wall is one-way rinsing with
high pressure water flow, and outer wall is spray-type cleaning with deionized water.
4)Sample injection pump
Sample injection pump is in the analyzer host left front door’s posterior aspect. After open the left
front door, you can see two injection pumps; one is sample injection pump, the other is reagent
injection pump.

1.6.4 Reagent processing system

Reagent processing system is mainly used for loading reagents, and then transfers each reagent to
the reagent absorbing position for absorb the reagent, and then inject it to reaction cup where reacts
with sample, and then measure the applied item parameter in reaction solution by optical detecting
system. The reagent processing system includes reagent tray, reagent adding mechanism, reagent
probe cleaning system and reagent injection pump.
1) Reagent tray
Warning
If you want to open the reagent tray cover or adding reagent, please make sure the
instrument is under standby mode or power off status, otherwise may damage the
instrument or cause personal injury.

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Reaction tray adopts the disc type physical design, is mainly used for loading reagent bottles, and
then transfers each reagent bottle to the reagent absorbing position, wait for reagent probe to absorb
the reagent.
Reaction tray provides 80 reagent positions, can be placed two specifications reagent bottle.
Reaction tray is integrated, including outer ring and inner ring, and provides 40 reagent positions in
each lap, No.78 is diluent position, and No.80 is detergent position.
The reagent tray with 24 hours non-stop refrigeration function, and the temperature keep in the range
of 2℃~8℃, make sure the reagent in reagent bottle is always stored in low temperature environment,
guarantee the stability of reagent nature, reduce volatility.
Note
The power supply of reagent refrigeration system is separate from the analyze part’s, so in
the case of main power is turned on, refrigeration system will always in working state.

2)Reagent adding mechanism


Reagent adding mechanism has the function of absorb certain amount of reagent from the regent
bottle, and then inject it to the reaction cup.
Reagent adding mechanism is composed of reagent probe, reagent probe rocker arm, reagent probe
drive shaft, reagent syringe and corresponding flow path, and it used for absorb certain amount of
reagent and then inject to the reaction cup, the same as sample adding mechanism.
The reagent probe also has the following functions:
a. Liquid level sensing and volume tracking: Reagent probe can automatically detect the liquid level
inside the reagent bottle, and according to absorb volume to determine the descending depth to
realize the volume tracking function.
b. Collision protection function: When reagent probe contacts the obstacle, the anti-collision
system will be automatically started to prevent from collision, so as to protect the reagent probe
from damage.
3)Reagent probe cleaning system
Using constant temperature water to clean inner and outer wall, inner wall is one-way rinsing with
high pressure water flow, and outer wall is spray-type cleaning with deionized water.
4)Reagent injection pump
Reagent injection pump is in the analyzer host left front door’s posterior aspect. After open the left
front door, you can see two injection pumps; one is sample injection pump, the other is reagent
injection pump.

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1.6.5 Stirring system

Stirring system is composed of sample stirring mechanism and reagent stirring mechanism. Sample
stirring mechanism is used for stir the mixed solution in reaction cup after inject the sample; Reagent
stirring mechanism is used for stir the mixed solution in reaction cup after inject R2.
Stirring mechanism is mainly composed of stirrer, rocker arm and the drive shaft, as shown in figure
1.6.5.

Figure 1.6.5 Reagent/Sample stirring mechanism


The hydrophobic material in the surface of stirrer can prevent the reaction solution was carried by
stirrer, and its work mode is rotation type.
The cleaning system of stirrer is fountain rinse, rinsing the stirrer from top to bottom.

1.6.6 Automatic cleaning mechanism

System support reaction cup eight-order-ten-step automatic cleaning, after the test, drain out the
reaction finished remaining solution, inject or drain out blank use distilled water through eight group
cleaning probes.
The cleaning hand is according to the order set by program to vertical rotation to rinse the reaction
cup.
Cleaning mechanism has collision protection function, when cleaning mechanism contacts the
obstacle, it will stop downwards movement, and at the same time stop injecting or draining, so as to
prevent leakage, as shown in figure 1.6.6:

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Figure 1.6.6 Cleaning mechanism


Table 1-1 Function of cleaning probes
No Cleaning probe Function No Cleaning probe Function
Group 5- short Inject distilled
Group 1- short probe Inject detergent
probe water
1 5
Drain waste Group 5- long Drain waste
Group 1-long probe
solution probe solution
Inject distilled Group 6- short Inject distilled
Group 2- short probe
water probe water
2 6
Drain waste Group 6- long Drain waste
Group 2- long probe
solution probe solution
Inject distilled Drain waste
Group 3- short probe 7 Group 7 probe
water solution
3 Inserting block
Drain waste
Group 3- long probe 8 Group 8 probe swab-absorb
solution
distilled water
Inject distilled
Group 4- short probe
water
4
Drain waste
Group 4- long probe
solution

Automatic cleaning mechanism uses the detergent and distilled water to eight-order automatic rinse
the reaction cup, which ensure the reaction up is no cross contamination and dry in testing process.
The rinse operations of cleaning mechanism are shown below:

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Phase 1: The group 1 probes are drain waste solution from reaction cup, and inject detergent to rinse
the reaction cup;
Phase 2: The group 2 probes are drain waste solution from reaction cup, and inject distilled water to
rinse the reaction cup;
Phase 3 to 6: The group 3 to group 6 probes are drain waste solution from reaction cup, and inject
distilled water to rinse the reaction cup;
Phase 7 to 8: Absorb and swab the reaction cup.

1.6.7 Flow path system

The instrument flow path system is mainly located inside the analyzer on the left side, is composed of
vacuum pump, solenoid valve, proportioner, cleaning system and tube system, etc. Using positive
and negative pressure control system, precise control of pressure, guarantee the stability of flow
path. Flow path system use a variety of valves and pumps to control the liquid and air moving to
realize the reaction cup, sample adding probe and stirrer rinsing function.

1.6.8 Photo-electrical detecting system

Photoelectric detection system unit is an optical system with fully enclosed, static, array type, light
split after chopped wave, is one of the core unit of automatic biochemical analyzer, its performance
directly affects the accuracy and precision of instrument. Main function is to produce light source,
light source split, receive light signal, complete photoelectric conversion, etc.
Halogen lamp produces stable continuous spectrum which through battery of lenses to appropriate
focus the light, and then the light pass through the cuvette, and then into the receiving lens, and then
enter the photoelectric detection system. Photoelectric detection system is composed of optical
system and signal detection system, its main function is measure the light intensity change when
light through the interactant, adopt the method of photoelectric conversion to change the optical
signal to electrical signal, by measure the electrical signal variation to reflect the change of light
intensity.
Photoelectric detection system has the following performance:
◆ Optional wavelength are 340nm, 405nm, 450nm, 480nm, 505nm, 546nm, 570nm, 605nm,
660nm, 700nm, 750nm and 800nm.
◆ Wavelength accuracy: ±1nm.
◆ Linear range:-0.5~6.0
◆ Resolution ratio:0.0001.
◆ Light source: Halogen lamp, 12V/20W.

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1.7 Optional modules

Optional modules are the parts which not belong to the instrument manufacture defaults. If the user
needs, they can be selected according to the actual situation. System supports the following optional
modules:
1) ISE module
2) Sample barcode scanning system
3) Reagent barcode scanning system

1.7.1 ISE module

ISE (Ion-Selective Electrode, electrolyte) is the abbreviation of Ion-Selective Electrode. ISE module
is made up of sodium (Na+), potassium (K+) and chloride (Cl-) selective electrode, reference
electrode, sample injection and measurement channel, syringes and effluent disposal components,
etc. It is mainly used for measuring the concentration of Na+, K+, Cl- and other ions in serum, plasma
and diluted urine. Measuring principle is indirect ion electrode selection method.

1.7.2 Sample barcode scanning system

Fixed sample barcode scanning system is located in the right side of the sample tray, and sample
barcode scanning system consists of the following components:
1) Sample barcode scanner
2) Bar code tag
3) Barcode scanning control hardware and software
After sample loaded into the sample tray, the system will automatically scan the bar code on the tube,
and then display the obtained sample information on the screen.

1.7.3 Reagent barcode scanning system

Fixed reagent barcode scanning system is located in the right side of the reagent tray, and reagent
barcode scanning system consists of the following components:
1) Reagent barcode scanner
2) Bar code tag
3) Barcode scanning control hardware and software
After reagent loaded into the reagent tray and cover the reagent tray cover, the system will
automatically scan all reagent positions, and then display the obtained reagent information on the
screen.

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1.8 Operation department

Operation department is a computer equipped with automatic biochemical analyzer operating


software, is made up of monitor, host, keyboard and mouse.
Operating software is biochemical management software installed on the computer, through
computer instructions to control the operation of the analyzer and to display the analysis result. In
order to guarantee the normal operation of the instrument, the analyzer application software should
be installed on the qualified computer.

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CHAPTER 2 INSTALLATION

Warning
Only the URIT technician can perform the installation of instrument.

Only the URIT technician can perform the installation of instrument, users shall make preparation for
satisfying the installation requirements in accordance with this manual before installation. If
relocation is necessary, please contact your local distributor or URIT.

2.1 Instrument inspection

Please check the carton according to the following procedures:


1) Carefully unpack the package and take out the Automatic Chemistry Analyzer and the
accessories.
2) Inspect the instrument and accessories for quantity and visible signs of damage according to the
accompanying Packing List.
3) If any loss or damage exists, contact the distributor or manufacturer immediately.

2.2 Installation requirement

Note
The instrument is high sophisticated thus proper installation is very important to its
performance. User should guarantee the environment and electrical condition are comply
with the recommended conditions. Provide a distance of 50cm at least for each side for
operating and maintaining.

2.2.1 Installment environment

1)For indoor use


2)Keep away from direct sunlight
3)Dust free
4)Installed on horizontal ground
5)Ground load capacity: 500kg
6)Atmosphere Pressure: 79kPa to 106kPa
7)Installation place no corrosive and flammable substance
8)Room temperature: 15℃ to 30℃

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9)Relative Humility: 40% to 85%


The reliability of data could not be guaranteed if the fluctuation of temperature and humility exceeded
the certain range.
10)Good ventilation does not face air conditioner
11)No obvious vibration
12)Keep away from electromagnetic field and electricity interruption
13)The instrument should be near to the power.
14) When the instrument transfer from outside to inside, if the temperature difference exceeds 10
degree centigrade, please turn on the instrument after 8 hours’ layup.

2.2.2 Power requirements

The following power must be prepared; switchboard should be located within 10m.
1) Power
Voltage 220V~, 50Hz
2) Grounding
Adapt to local power needs, using three-pin power plug
3) Plug board
A 20A output plug board with more than three 5A sockets. Heavy-duty devices should not share the
plug board with the instrument, such as refrigerator, air conditioner etc.
4) 3 core power cable cat is using; the type of wire and plug is depended on voltage.
Warning
1. Make sure the instrument is grounded properly. Poor grounding may cause bad effects
on test result and even damage to the instrument.
2. Customers should prepare an uninterrupted power supply which power is 3000W or
above, to prevent power fluctuation and interrupt from other instruments or power.

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2.2.3 Location requirements

The instrument installation layout is below. Surrounding distance is the recommended maintenance
space.

Instrument Dimension: 95cm×64.3cm×111.4cm (L×W×H)


Dimension of Operating Board (Only for reference): 70cm×50cm×80cm (L×W×H)

2.3 Instrument connection

Caution
Please connect the instrument under the instruction of URIT service engineer or the
personnel authorized by URIT.

After the instrument was installed, needs to connect the power line, communication line, flow path
tubes to run properly.

2.3.1 Connect the power line and communication line

1) Take out the power line, one end insert into the power interface of instrument, the other end
connected to the power.
2) Using the communication line which provided by URIT for connection. One end connects to the
COM serial port of computer; the other end connects to the RS232 serial port of instrument. And
please tighten by the screws.
Caution
When connect the communication line, please shut down the instrument power first.

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2.3.2 Connect the flow path

Biological Hazard
1) Because the waste solution is contaminated, do not let your hands and clothes
contact with the waste solution when processing waste liquid. If your hands and
clothes contact with the waste solution, please rinse with water immediately; if your
eyes contact with the liquid, please rinse with water immediately and consult a doctor.
2) Please comply with the relevant clauses in medical waste handling regulations to
handle the waste liquid.

Please correctly connect the flow path tubes after the instrument connection has been completed.

2.3.2.1 Connect the distilled water bucket

1) Filled the bucket with distilled water;


2) Take out the distilled water tube from the accessory kit, one end connected to the distilled water
interface of the instrument, the other end connected to distilled water bucket;
3) Take out the BNC wire from the accessory kit, one end connected to the distilled water BNC
interface of the instrument, the other end connected to the BNC interface of the distilled water
bucket.

2.3.2.2 Connect the waste solution bucket

1) Take out the waste solution tube(big size) from the accessory kit, one end connected to the waste
solution interface of the instrument, the other end connected to waste solution bucket;
2) Take out the waste solution tube(small size) from the accessory kit, one end connected to the
waste solution interface of the instrument, the other end connected to waste solution bucket;
3) Take out the BNC wire from the accessory kit, one end connected to the waste solution BNC
interface of the instrument, the other end connected to the BNC interface of the waste solution
bucket.
Note
1) After complete the connection of flow path tubes, please do not start the instrument until
filled the distilled water.
2) The outlet of waste solution tube(big size) should below the instrument water outlet.

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2.3.2.3 Connect the detergent bucket

1) Filled the bucket with detergent;


2) Take out the detergent tube from the accessory kit, one end connected to the detergent interface
of the instrument, the other end connected to detergent bucket;
3) Take out the BNC wire from the accessory kit, one end connected to the detergent BNC interface
of the instrument, the other end connected to the BNC interface of the detergent bucket.

2.3.3 Connect the printer

1) Confirm the computer of operation department has installed the printer driver;
2) Connect the printer to analyzer by right data cable;
3) Place printing paper.

Note
Please install the printer type which supported by computer operating system.

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Operating manual

CHAPTER 3 SYSTEM SETTINGS

This chapter is mainly introduces the basic setup methods of the instrument, including: ordinary item
parameter setting, special item parameters setting, calibration setting, quality control setting and
system parameter setting.

3.1 System menu

Biochemical test Item parameter setting Normal item parameter setting

Combination item setting Special item parameter setting

Calculated item setting

Item display, Print order setting

Biochemical QC management QC material setting

Routine test QC result processing

Emergency test QC chart analyzing

Special test Calibration and QC test

A/D signal reading

Maintenance Probe and Stirrer Cleaning

Reaction cup rinsing

Reaction cup signal reading

Instrument parameter setting

System parameter Communication port and Hospital name setting

Hospital information setting

Hospital display color setting

Data processing Sample information registration

Test result query

Test result correction

Test curve display

Database maintenance Database backup

Help Help Database restores

About software

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Operating manual

3.2 Normal item parameter setting

Click on icon in software operating main interface, and then input password to enter
the parameter setting interface. This interface is mainly used in normal parameter setting.
If meet the following conditions, the system allows you to modify the parameters of normal item:
◆ The user has sufficient permissions.
◆ System is not in test status.

Note

1) The general project parameter software is closed by default, and the customer can only
modify some basic parameters. If you need to modify or add new project
parameters, please contact URIT Medical Electronic Co, Ltd.
2) In this chapter, the general project parameters are set up under the reagent opening.

3.2.1 Setting interface

This chapter is mainly introduces how to set up the basic parameters of the item, including item
name, test method, test wavelength, correction factor, test unit, test priority, reaction direction,
standard factor, calibration test number, standard number, standard position, standard value and
calibration rule.
In normal item parameter setting interface, select setting option to enter setting interface, as shown:

Figure 3.2.1 Setting interface

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In setting interface, the meaning of the function keys is as follows:


【ADD】: Create a new normal item
【SAVE】: Save the current interface information
【DEL】: Delete the selected normal item
【PRINT】: Print the basic information of the selected normal item

: Up move the selected normal item one position

: Down move the selected normal item one position

: Move the selected normal item to the top of the list

: Move the selected normal item to the bottom of the list


In normal item parameter setting interface, the meaning of each parameter is as follows:
1) Name:
Refers to the item name, is the only mark of the item, repeat is not allowed, allows enter the following
characters:
◆ Number
◆ Letter
◆ Underline
Input is case insensitive.
2) Byname:
Refers to the other name of the item, it can further explain the item name.
3) Decimal place:
To select the test result should keep how many places of decimal, can be set up 0~4 decimal places.
4) Test method:
Analysis method is used in calculate the test results. Options include: End point method(One end
point method), Rate method(kinetic method), Two point end method and Two point rate(Fixed-time
method). The specific meaning of each method, please refer to “chapter 5.2 test method”.
5) Blank setting:
Set up the blank reading point, there are two kinds of setting mode: Normal mode and advanced
mode. Normal mode is selects the fixed point, but advanced mode need according to the
corresponding immune reagent item’s response curve to determine the starting point and end point.
This button only appears when you select the “End point method” as the test method. For the specific
introduction, please refer to “chapter 7.1 blank setting”.

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6) Dominant wavelength:
The dominant wavelength should be selected according to the absorbed light characteristics of the
specific reaction products, is used in measure the intensity of light absorption of reactant.
7) Complementary wavelength:
When test an item, the complementary wavelength is used for eliminate the interference cause by
other interfering substances. Such as: Light flashing, drift, reaction cup scratches, etc. Options are
the same as dominant wavelength. Complementary wavelength cannot be the same as the dominant
wavelength. When complementary wavelength displays as NONE, that means is single wavelength
method.
8) Unit:
The unit of item result. Table 3-1 lists the units for some common biochemical item results.
Table 3-1 Biochemical item results units table
No. Unit English name
1 % Percent
2 g/dL Grams per deciliter
3 g/L Grams per liter
4 IU/mL International units per milliliter
5 mg/dL Milligrams per deciliter
6 mg/L Milligrams per liter
7 mmol/L Millimoles per liter
8 U/L Units per liter
9 Umol/L Micromoles per liter
9) Test priority:
When measuring multiple items of the same sample, the system will first test the item with high
priority. Options includes: PRI_1 ~ PRI_36 and the priority level is gradually reduced. PRI_1 has the
highest priority will be first tested. So like that, PRI_36 has the lowest priority will be last tested.
10) Correction factor(y=ax+b) :
It is used for item standard factor correction. Correction factors including slope and intercept, when
the QC test result of an item appears overall small amount deviation, the correction factors are the
compensation factors for system to do compensation calculating. After test, the system will
automatically use the correction factors according to the following formula for correcting test result:
y = ax + b.
x is the test result before correction;
y is the test result after correction;
a is the correction slope;

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b is the correction intercept.


11) Standard factor:
Standard factor is the K value. The system will automatically correct this standard factor after the
calibration test, the user can also according to the standard factor given by the reagent specification
to manual input. The item can be direct test after manually input the standard factor without
calibration, otherwise must be calibrated first.
Note
Standard factor setting method is only applied to one point standard item.

12) Cleaning before or after the test:


For pollution especially big item, you should use detergent to rinse the sample probe and reagent
probe before or after the test. If you want to rinse, just check this option.
13) Reaction direction:
Absorbance is increase or decrease during the reaction process. Reaction direction can only be set
under the test method of rate method, including positive reaction and side reaction.
Positive reaction: Absorbance is increasing with the extension of time.
Side reaction: Absorbance is decreasing with the extension of time.
14) Substrate exhaustion:
Substrate exhaustion is only effect on rate method.
Substrate exhaustion does not means the substrate in reaction solution has been used up, because
the enzymatic reaction is reversible, even if the reaction is achieve a balance, but according to
different equilibrium constants, there will have different proportions of substrate to retain in the
reaction solution. That is to say, when test the initial speed in enzymic catalytic reaction, the
substrate is in a state of excess. For the specific introduction, please refer to chapter 7.2 substrate
exhaustion.

3.2.2 Reagent, Sample and Time Setup Interface

In normal item parameter setting interface, select Reagent, Sample and Time Setup to enter
interface. This interface is mainly set the reagent volume, incubation time, position, sample volume
and test point.

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Figure 3.2.2 Reagent, Sample and Time Setup interface


In the interface, the meaning of each parameter is as follows:
1) Reagent volume(Volume (ul)):
Reagent volume needed for test, including the first reagent and second reagent. Please according to
the reagent specification or laboratory related documents to set in proportion.
2) Incubation time (Inc.Time(s)):
In the end point method, it is the time from sample and reagent start mixing to reaction endpoint; in
the two point method, it is the time from the first absorbance selection point starts to the second
absorbance selection point ends. Double reagent method need to set the incubation time for both
reagents. Please according to the reagent specification or laboratory related documents to set.
3) Position:
Position is for you to place the reagent in reagent tray. Position 2 and position 3 are the position for
spare reagents, so please according to the dosage of reagents in the day to use them, in order to
avoid frequent added reagents.
4) Sample volume (Sample Vol.(uL)):
The needed sample volume which is inject to reaction cup during the test.
When you input the sample volume, please notice that, the total volume of reaction solution (sample
volume + reagent volume) must be between 150uL to 900uL. If the input parameter does not meet
the requirements of reaction solution volume, the system will pop up error message. At this time,
please check the input sample volume and reagent volume.
5) Test Point:
After incubation time, the system will continue to read the change of absorbance test points of test
item.

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3.2.3 Normal Value Range Interface

This part is used to set the normal reference range of each test item according to different gender
and age. Reference range refers to the concentration range of the normal sample. If the test results
exceeding the range, that means the patient may be in bad health status. During the test, if any
results exceeding the range will be marked H (High) or L (Low). H means the results are higher than
the upper limits, while L means the results are lower than the lower limits.
In normal item parameter setting interface, select Normal Value Range to enter Interface. This
interface is mainly used for sets the normal reference range of each test item, and then compares
them with the test results.

Figure 3.2.3 Normal Value Range Interface


This interface can choose different patient attributes, including Blank, Male, Female, and Child. In the
Interface, the meaning of each parameter is as follows:
1) Linear Range:
Linear range of determination results and reaction degree R (reaction degree: Reaction solution
absorbance and the change rate of absorbance), it shows the measurable range of instrument. User
should according to the reagent specification to set, and the system will automatically mark the
results exceeding the range as non-linear.
Warning
If the linear range of test result is exceeding the range, then the accuracy of test result
cannot be guaranteed, please retest the sample through Sample retest or Pre-dilution
retest.

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2) Abs warning:
Set the alarm range of absorbance, when exceeding this range, the system will automatically start
the Abs warning function. Absorbance value set range is between -4.0 ~ 5.0.
3) Superlinear auto retest:
Select whether use Superlinear auto retest function.
After you select the Superlinear auto retest and Sample, for the item result exceeding the linear
range, then the system will automatic retest.
After you select the Superlinear auto retest and PREDILUTE, for the item result exceeding the
linear range, the system will automatic according to the set dilution ratio to retest it.
More information about Superlinear auto retest, please refer to chapter 4.9.2.2 Automatic retest
after exceeding linear range.
4) Automatic retest after substrate exhaustion:
Select whether use Automatic retest after substrate exhaustion function. This option applies only
to rate method.
After you select the Automatic retest after substrate exhaustion and Sample retest, after
substrate exhaustion, the system will automatic retest this item.
After you select the Automatic retest after substrate exhaustion and Pre-dilution retest, after
substrate exhaustion, the system will automatic according to the set dilution ratio to retest this item.
More information about Automatic retest after substrate exhaustion, please refer to chapter
4.9.2.3 Automatic retest after substrate exhaustion.
Warning
If appear the phenomenon of substrate exhaustion, you must to retest the sample, please
retest the sample through Sample retest or Pre-dilution retest.

Substrate exhaustion judgment method 2:This option applies only to rate method, please refer to
chapter 7.2.3 Substrate exhaustion judgment method 2(Slope ratio).

3.2.3.1 Added normal item

1) Click ADD button to add a new blank item;


2) Input the basic parameter, parameter range, sample volume and reagent volume;
3) Click SAVE button to save the current information.

3.2.3.2 Modify normal item

1) Select the item which needs to modify from the left side inspection item list, and then enter the
basic information interface of this item;

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2) According to the lab needs to modify the parameters;


3) Click SAVE button to save the modified information.

3.2.3.3 Delete normal item

1) Remove the not needed item reagent from the reagent tray;
2) Select the item which needs to delete from the left side inspection item list;
3) Click DEL button to delete the item.

3.3 Special item setting

This chapter is mainly introduces the setting of some special items, including the special item
parameter, calculated item and profile item.

3.3.1 Special item parameter

Special item parameter is the item which cannot be direct tested by the analyzer, but need to print
with the other items which tested by the analyzer on the same report, or use the analyzer printer to
print other instrument’s item inspection report.
Click menu Biochemical test→Item parameter setting→Other parameter to enter the interface.

Figure 3.3.1 Special item parameter interface


The data types of this interface are Float and Char.

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3.3.1.1 Added special item parameter

1) Select the data type for special item parameter;


 Float: Select the unit, decimal place, normal low value and normal high value of test result.
 Char: Indicates the test results of this item are text type input, for example: Negative and
Positive.
2) Input the test item name and byname on【Item】and 【Byname】respectively;
3) If you select Float, and then please input unit, decimal place, normal low value and normal high
value;
4) Click SAVE button to save the special item parameter setting.
Note
The results of the special item need through the 6.3.4 Result edit/modify to add to the
sample results list.

3.3.1.2 Delete special item parameter

1) Select the item which needs to delete from the item parameter list
2) Click DEL button to delete the item.

3.3.2 Calculated Item Setting

Calculated item is a kind of indirect test item, calculated by different items, and has a certain clinical
significance, such as A/G, ALT/AST, etc.
Calculated item is a special formula composed of participate items, calculation symbols and
calculating relations. Only the user who has specific authority can set, modify or delete the calculated
items. The print order of calculated items can be set; please refer to “chapter 6.5.1 Item print order
setting”.
Calculated item does not participate in sample test, so does not need to do calibration and QC test.
The result of calculated item is using the final results through calculating formula to get.
Click menu Biochemical test → Calculated Item to enter the interface. This interface is used for
change the name, reference range, unit, decimal place and calculation formula of calculated item.

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Figure 3.3.2 Calculated item setting interface

3.3.2.1 Added calculated item

1) Click ADD button;


2) Input the calculation formula in【Formula】;
By clicking on the left side item list to select the needed items and input the calculation symbols
to form the calculation formula;
3) Input the number of required decimal place for test results in【Decimal】;
4) Select the required unit for test results from the【Unit】drop-down menu;
5) Input the normal low value and normal high value of test results in【Normal L】and【Normal H】
respectively;
6) Click SAVE button to save the calculated item setting.

3.3.2.2 Delete calculated item

1) Select the item which needs to delete from the calculated item list;
2) Click DEL button to delete the item.

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3.3.3 Profile item setting

Profile item is combine related items together to form a new item which has obvious clinical
significance, such as: liver function, renal function, etc. At the same time, it is also convenient for
user rapid application.
Profile item is consists of selected biochemical items, does not include calculated item and ISE item.
Only the user who has specific authority can set, modify or delete the profile items.
Click menu Biochemical test→Profile to enter the interface.

Figure 3.3.3 Profile item setting interface

3.3.3.1 Added profile item

1) Input the name of profile item in the edit box below【Item name】;
2) Click Add Profile button to add a new profile item;
3) Select the required items from the right side item name list;
4) Click ADD button to add the selected items to the profile item list.

3.3.3.2 Delete profile item

1) Delete the single item from the profile item: Select the item which needs to delete from the profile
item list, and then click DEL button to delete it.

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2) Delete the entire profile item: Select the profile item which needs to delete from the item name
list, and then click Delete Profile button to delete it.

3.4 Calibration setting

Item calibration test application can only be allowed when you have correctly set the calibration
parameters, which including calibration number, calibration method, calibration solution
concentration and position for the corresponding item. Calibration setting only allowed when the
system is in standby mode and the user has certain permissions.

Click on icon in software operating main interface, and then input password to enter
the parameter setting interface. Calibration setting can be done in this interface.

Figure 3.4 Calibration parameter setting interface


1) Input the calibration solution repeat test number in【Tests of Calibration】. Numerical range is
between 1 to 5, the default is 1;
2) Input the calibration solution number in 【STD number】;
◆ One item can set 8 calibration solution at most
◆ The number of calibration solution and their corresponding calibration rules, shown in the table
below:
Calibration method Standard number
Single point linear N=1
Two point linear N=2
Multiple point linear 3≤N≤8
Parabola N=3
Broken line 3≤N≤8
Logistic-Log 4P 4≤N≤8
Logistic-Log 5P 5≤N≤8
Exponential 5P 5≤N≤8
Spline 3≤N≤8
Weibull 3≤N≤8

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3) In 【 STD Position and value 】 drop-down list, select the position for calibration solution in
sample tray; In 【 STD Position and value 】 , input the calibration solution concentration for
corresponding item.
4) Select the calibration rule in【Calibration rules】 drop-down list.
5) Click SAVE button to save the calibration setting.

3.5 QC setting

Item QC test application can only be allowed when you have correctly set the QC parameters, which
including control solution lot number, control solution manufacturer information, target value and SD
value. QC setting only allowed when the system is in standby mode and the user has certain
permissions.
Click Biochemical test→Biochemical QC Management→QC Setup to enter interface.

Figure 3.5 Control solution setting interface

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3.5.1 Added control solution lot number

1) Input the control solution lot number in【Lot】;


◆ Control solution lot number is not allowed to repeat
◆ Lot number can be composed of all kinds of characters and numbers
2) Click Add QC Lot button to save the control solution lot number;
3) Select the item which needs to set from the right side item list;
4) Click ADD button to add the item to the QC list;
5) Select the item which needs to set target value and SD value from the QC list;
6) Input the target value in 【Target value】;
Target value must be greater than 0.
7) Input the SD value in 【SD】;
SD value must be greater than 0.
8) Input the QC low value and QC high value in 【QC low】and【QC High】respectively; also you
can just click Evaluate button, and then the system will automatic calculate the QC low value
and QC high value according to the target value and SD value.
QC low value: The lower limit of QC reference value.
QC high value: The upper limit of QC reference value.
9) Click SAVE button to save the QC setting.

3.5.2 Delete control solution lot number

Control solution lot number can only be deleted when the system is in standby mode and the user
has certain permissions. After delete the control solution lot number, the other control solution
information, target value and SD value will be deleted too.
1) Delete the single QC item: Select the QC item which needs to delete from the QC List, and then
click DEL button to delete it.
2) Delete control solution lot number: Select the control solution lot number which needs to delete
from the QC Lot List, and then click Del QC Lot button to delete it.

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3.6 System parameter setting

System parameter is divided into six sub setting interfaces, respectively are communication port and
hospital name setting interface, hospital information setting interface, Chart display color setting
interface, Lis connection setting interface, Print setting interface and Barcode setting interface.

3.6.1 Communication port and hospital name setting

Click menu System parameter→Heading to enter the interface.

Figure 3.6.1 Hospital name setting interface


1) Input hospital name in【Hospital】;
2) Input hospital address in【Address】;
3) Click SAVE button to save setting.

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3.6.2 Hospital information setting

Click menu System parameter → Hospital to enter interface. This interface is divided into three
sub-interfaces, respectively are inspection department setting interface, clinician setting interface
and laboratory physician setting interface. And the default interface is laboratory physician setting
interface.

Figure 3.6.2 Laboratory physician setting interface

3.6.2.1 Laboratory physician setting

1) Added laboratory physician


1 Input laboratory physician name in【Operate Name】;
2 Input laboratory physician code in【Operate ID】;
3 Select the high priority for higher privilege laboratory physician;
Laboratory physician without high priority cannot modify the normal item parameter, profile
item setting and calculated item setting.
4 Click SAVE button to save the current setting;
5 Click Password button to open the laboratory physician password setting dialog box;

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Figure 3.6.2.1 Laboratory physician password setting interface


6 Input laboratory physician code in【Operator ID】;
7 Input laboratory physician password in 【New Password】;
8 Input laboratory physician password in【Confirm Password】again;
9 Click ENTER button to complete the setting.
2) Delete the laboratory physician
1 Select the laboratory physician which needs to delete from the laboratory physician code
and name list;
2 Click DEL button to delete it.

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3.6.2.2 Inspection department setting

Click Department option in Hospital information setting interface to enter the interface.

Figure 3.6.2.2 Inspection department setting interface


1) Added inspection department
a) Input inspection department name in【Department】;
b) Click SAVE button to add the inspection department.
2) Delete the inspection department
a) Select the inspection department which needs to delete from the Department List;
b) Click DEL button to delete it.

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3.6.2.3 Clinician setting

Click Doctor option in Hospital information setting interface to enter the interface.

Figure 3.6.2.3 Clinician setting interface


1) Added clinician
a) Input clinician name in【Doctor】;
b) Select the corresponding inspection department from the Department drop-down list;
c) Click SAVE button to add the clinician.
2) Delete the clinician
① Select the clinician which needs to delete from the Doctor List;
② Click DEL button to delete it.

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3.6.3 Diagram display color setting

Click menu System parameter→Chart Color Setup to enter interface. The color of diagram can be
set individuation in this interface, select the color from the drop-down list, click SAVE button to save
the setting.

Figure 3.6.3 Diagram display color setting interface

3.6.4 Lis connection setting

Click menu System parameter → Lis connection setting to enter interface. Lis host connection
parameter and test results transmission mode can be set in this interface. For more information,
please refer to chapter 7.4 Lis setting.

3.6.5 Print setting

Click menu System parameter → Print setting to enter interface. Item print order can be set in this
interface. For more information, please refer to chapter 7.5 User-defined print setting.

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CHAPTER 4 BASIC OPERATION

Following show the basic operation procedures of instrument. Suggesting perform standard analyses
every day after start-up and do control analyses.

4.1 Operation procedures

Table 4-1 Operation procedures

Related
Operation procedures Description
chapter

Check sample probe/stirrer, distilled water


1. Check before powering on bucket, waster solution bucket ,detergent 4.2
bucket and power supply

Power on, start the operating system,


2.Power on 4.3
confirm the instrument and reagents status

Biochemical reagent and detergent


3. Pre-test preparation 4.4
preparation

Calibration solution preparation, Calibration


4. Calibration test 4.5
test application, start calibration test

Control solution preparation, QC test


5. QC test 4.6
application, start QC test

Sample preparation, routine sample test


6. Routine sample test 4.7
application, start sample test

Emergency sample test application, Start


7. Emergency sample test 4.8
emergency sample test

Sample complementing test, modify


8.Special test sample test, sample retest and diluted 4.9
sample test

Check reagent tray/sample tray/reaction


9. Test status and stop tray status, Pause/exit/emergency exit 4.10
operations

Maintenance operations, such as empty


10. Routing maintenance 4.11
the waste solution

Power off, 24 hours standby and power off


11.Power off 4.12
operation

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4.2 Check before powering on

Please check the following matters before powering on, to guarantee the normal work of the system
after start.

1) Check the power supply

◆ Check the power supply to confirm it has the ability to provide correct voltage.

◆ Check whether the UPS switch is in ON status.

◆ Check whether the analyzer host, computer and print are both well connected.

2) Check the print

◆ Check whether the printer paper is enough and properly installed.

3) Check the sample adding system

Sample probe, reagent probe and stirrer are easy to get dirty or damaged, so before starting up,
please look for any dirt or bending.

◆ Check sample probe, reagent probe and stirrer are whether stained with water or dirt, whether
bend or clogged.

◆ Check each rinse tanks are whether stained with dirt or clogged.

If sample probe, reagent probe and stirrer are stained with dirt, please refer chapter 9.4.1 for
cleaning.

If sample probe and reagent probe are clogged, please refer chapter 9.6.2 and chapter 9.6.3 for
unclogging.

If sample probe, reagent probe and stirrer are bending, please contact URIT for replacing.

If rinse tanks are stained with dirt or clogged, please refer chapter 9.4.2 to operate.

4) Check the detergent and the diluent

The instrument could not continue testing when the detergent is inadequate, so please make sure
the detergent is enough.

◆ Check whether the detergent in sample tray and reagent tray are enough. If not, please timely
adding or replacing.

◆ Check whether the diluent in reagent tray is enough. If not, please timely adding.

◆ Open the front door of the analyzer host, and then check whether the detergent in detergent
bottle is enough. If not, please timely adding or replacing.

For the specific operation, please refer to chapter 9.3.2.

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Warning
1) In order to ensure the cleaning effect and instrument performance, please use the
detergent specified by URIT, otherwise may cause the instrument damage.
2) When adding detergent into detergent bucket, do not over the marked the highest line.

Biological Hazard

DO NOT touch the detergent. If it adheres to hands or clothes, wash it off with water
immediately. If it splashes into eyes, wash it off with water immediately and consult a
doctor.

5) Check the distilled water bucket and the waste solution bucket

The instrument could not continue testing when the distilled water is inadequate or waste solution
bucket is overfill, so please check the following maters before power on.

◆ Check whether the distilled water is enough. If not, please timely adding.

◆ Check whether the waster solution is too much. If yes, please empty the waste solution bucket.

◆ Check whether the flow path tubes are bending or leakage.

Note

In order to ensure the accuracy of test results, avoid flow path clogged, please use the
water machine to make water.

Biological Hazard

1) When check the connection of waster solution, be sure to put on protective gloves,
clothes, or even goggles if necessary.
2) DO NOT touch the waster solution. If it adheres to hands or clothes, wash it off with
water immediately. If it splashes into eyes, wash it off with water immediately and
consult a doctor. Please comply with the relevant clauses in the medical waste
management regulations to handle the waster solution.

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4.3 Starting up

4.3.1 Turn on the instrument

After the instrument is properly connected to a power outlet, you should according to the following
order to turn on the instrument.

1) Turn on the instrument power switch (In the right side of instrument);
2) Turn on the instrument test switch (In the right side of instrument).

Power switch

Test switch

Figure 4.3.1 Switch

Remind

For power switch and test switch, switch up is on-state, I is on, O is off.

Note

The instrument has two switches: power switch and test switch, turn on the power switch
instrument to start work outside the part of the light circuit, and open the test switch part off
the work. The instrument standby state can be turned off test switch to extend lamp life.

3) Turn on the display monitor of computer of the operation unit;


4) Turn on the computer of operation unit;
5) Turn on the printer.

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4.3.2 Start the operating software

1) After log in the Windows operating system, and then double-click the biochemical management
software desktop icon; or select Start → Program to start the biochemical management
software. Wait until pop up the login dialog, as shown in the figure below:

Figure 4.3.2 Login interface

2) Input the registered doctor’s name and the corresponding password to enter system to operate
analyzer.
3) Switch to another user: System allows different users to login by clicking Log out on the main
interface.

Figure 4.3.2-2 Self-test for instrument parameter

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4) After self-test over, the following dialogue box will pop up. Click execute to begin.

Figure 4.3.2-3 maintenance before test

Note

Be sure the cover of NO.80 reagent bottle has been take off before click execute, otherwise
will cause probe collision.

5) Switch user: user can click logoff to switch user.

Note

User authority management is applied to limit certain function for low permission user,
which is benefit for user to manage the software reasonably. There are three user groups,
user, administrator and guest.

Note

Instrument with the function of 24 hours stand-by, auto sleep and one-key setup.

Caution

In order to ensure accurate test results, please preheat 30 minutes after turn on the
instrument, and then start testing operation, to ensure that the light source and
temperature control are stable.

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4.3.3 Confirm the instrument status

After start, please check various states of instrument if necessary, such as: check the temperature of
reagent tray and reaction tray, and the status of detergent, distilled water and waste solution. Make
sure they are all right. If not, please refer to chapter 9 Care and Maintenance and chapter 11 Alarm
and troubleshooting to operate.

1) Check whether the analyzer host sends alarm sound;


◆ If yes, that’s means the instrument has something wrong. Continue to the next step;

◆ If not, the instrument status still needs to be confirmed. Continue to the next step.

2) Click menu bar Instrument maintenance → Instrument status query, this interface will display
instrument status and marked the abnormal status.

4.3.4 Confirmation the reagent status

Before the test, it is necessary to check whether the reagent is placed on the correct position in
reagent tray, whether the reagent remaining volume is enough for the tests.

1) Click the icon in main menu to enter the routine sample test application interface;
2) Select the Standard option;
3) Click the lower right corner Remaining volume button to enter the reagent information interface;
select Query Reagent option, this interface will display the reagent position in reagent tray, item
name, reagent type, reagent remaining volume and test number.

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Figure 4.3.4 Reagent remaining volume query interface

4) Check the items which need to examine the reagent remaining volume;
5) Click Query Reagent button to examine them.

4.4 Pre-test preparation

4.4.1 Prepare the biochemical reagent

After confirm the instrument status, please prepare the measurement using reagent.

Biological Hazard
1) Be careful not to spill out reagent. If reagent is spilled, wipe the area by dry fabric
immediately.
2) When replace the reagent, be sure to put on protective gloves, clothes, or even
goggles if necessary. If it adheres to hands or clothes, wash it off with water
immediately. If it splashes into eyes, wash it off with water immediately and consult a
doctor.
1) Be sure to use the certified reagents. Read through the reagent instructions and set up
parameters properly before analyses. For biochemical item parameter setup, please refer to
chapter 3.1 Normal item parameter setting.

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2) If reagent is insufficient, replace it with a whole new bottle. Place the reagent bottle in the
specified position according to the preset reagent parameters. Please according to the following
operations to place the regent:

◆ Click the icon in main menu, and then select the Standard option;

◆ Click the lower right corner Remain button to check the remaining volume and reagent position,
the user should according to the item and position in this interface to place the corresponding
reagent.

3) Reagent should be stored at temperature of 2℃~8℃. Long-time exposure in the air may
deteriorate the reagents.

Note
1) In order to avoid firing pin phenomenon, please correctly place the reagent bottle.

2) Air bubbles are not permitted in the reagent bottle.

3) Please make sure the instrument is in standby mode or turned off when open or
closed the cap of reagent bottle in reagent tray.

4.4.2 Prepare the detergent

Detergent is used for clean the reaction cup, reagent probe and sample probe. So when detergent is
insufficient, the system will pop up alert information, in order to not affect the test result, please add
detergent timely.

Dilute detergent proportionally, and then add into the detergent bottles, sample cup (tube) which on
the position for detergent of sample tray and reagent bottle which on the position for detergent of
reagent tray.

Warning

1) Don't mistake the original detergent, such as acid detergent and alkaline detergent,
when they mixed, it will produce poisonous gas.
2) When using concentrated detergent, please dilute detergent properly first.
3) Be careful not to spill out original detergent. If original detergent is spilled, wipe the
area by dry fabric immediately. Otherwise it will produce poisonous gas and damage
the instrument.
4) When adding detergent into detergent bucket, do not over the marked the highest line.

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Biological Hazard

DO NOT touch the detergent when open the original detergent bucket. If it adheres to
hands or clothes, wash it off with water immediately. If it splashes into eyes, wash it off
with water immediately and consult a doctor.

4.5 Calibration test

Test the absorbance change rate of the known concentration calibration solution, and then according
to the computational relationship between concentration and change rate (Calibration method), to
calculate the coefficient of the computational relationship (Calibration coefficient), and then
determine the specific operation expression between concentration and change rate. So the routine
sample can be tested according to the specific operation expression and the absorbance change
rate.

It is suggested to perform calibration every six months or under the following situations:

 When initially installing and running the instrument.

 Added a new item.

 When changing reagent batch number or type, unless specified by the lab that the change will
not influence the precision.

 After replacing the major components, such as lamp, sampling mechanism, probe, or cuvette
etc.

 After performing a preventive maintenance on the instrument.

 When control result shows abnormal offset, tendency, or falls out of the acceptable range and it
cannot be corrected by routine tests.

4.5.1 Prepare the calibration solution

According to the calibration specification and related laboratory requirements to prepare the
calibration solution, and then add proper volume of calibration solution into sample cup and place the
cup in the standard position to do the calibration operation.

Biological Hazard

Incorrect use of calibration solution can cause infection, do not let your hands contact with
the calibration solution. Be sure to put on protective gloves, clothes, or even goggles if
necessary. If the calibration solution splashes to the skin accidentally, please treat
immediately according to the working standards and consult a doctor.

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Caution

Do not use the expired calibration solution, otherwise may lead to inaccurate
measurements.

4.5.2 Application for the calibration test

After prepare the calibration solution, please according to the steps below to apply for calibration test.
Before apply for biochemical item calibration test, please make sure that the concentration and
position of calibration solution have been set up correctly, details please refer to chapter 3.3
calibrations setting.

1) In menu, click Special test→Standard and QC Analyses to enter the interface;

Figure 4.5.2 Calibration and QC test application interface

2) Select the item you need to calibrate, and then click ADD button to add it into the right side test
item list, and also you can see the position information of calibration item in this interface.

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4.5.3 Start the calibration test

After calibration test application and correct place the calibration solution in sample tray, now you can
starting the calibration test.

1) Click TEST button to enter the test interface;


2) Click TEST button in test interface to start the calibration test.

Caution Note

Before test, please make sure the calibration solution has been correctly selected and
placed.

4.6 QC test

Every time after perform a calibration test, replace reagent lot number, perform maintenance and
troubleshooting operations, please perform a QC test to make sure that the instrument performance
is stable.

QC test might need multiple quality control samples. In order to determine whether the instrument
test performance is stable, after establish the standard curves, please run the QC test for every test
items in everyday, quality control tests including test the control solution in high and low
concentration each three times when before test, under testing and after test.

Note

QC test results must within the allowed error range before test the actual sample.

4.6.1 Prepare the control solution

According to the control solution specification and related laboratory requirements to prepare the
control solution, and then add proper volume of control solution into sample cup and place the cup in
the QC position to do the QC operation.

Biological Hazard

Incorrect use of control solution can cause infection, do not let your hands contact with the
control solution. Be sure to put on protective gloves, clothes, or even goggles if necessary.
If the control solution splashes to the skin accidentally, please treat immediately according
to the working standards and consult a doctor.

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Caution

Do not use the expired control solution, otherwise may lead to inaccurate measurements.

4.6.2 Application for the QC test

Before apply for biochemical item QC test, please make sure you have complete the parameter
setting, such as target value and SD value. Details please refer to "Chapter 3.4 QC setting".

1) In menu, click Special test → Calibration and QC test to enter the Calibration and QC test
interface;
2) Select the wanted QC lot number from the QC lot number list, after the lot number has been
selected, then all the QC items under that lot number will be displayed in QC item list;
3) Select the QC sample position from the lower right corner drop-down list;
4) Click Apply button, then the position information will be displayed;
5) Click ADD button to add it into QC item test list. If an item in that lot number is not need to do QC
test anymore, just select that item in QC item test list, and then click DEL button to delete it.

4.6.3 Start the QC test

After QC test application and correct place the control solution in sample tray, now you can starting
the QC test.

1) Click TEST button to enter the test interface;


2) Click TEST button in test interface to start the QC test.

Note

Before test, please make sure the control solution has been correctly selected and placed.

4.7 Routine sample test

If QC test results are indicate the system is under controllable range, then you can start test patient’s
sample.

This section describes how to apply routine sample tests. You can apply for single biochemical item
test and profile item test. Before test, please make sure that the test items’ parameters have been set
up correctly, including: test method, test wavelength, sample volume and reagent volume, etc.,
details please refer to "Chapter 3.1 Normal item parameter setting".

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4.7.1 Prepare the sample

Add the sample into the specific sample cup, or directly use the test tube which meets the
requirement of instrument specification. In test interface, select the corresponding sample position to
perform the sample test.

Note
Before add the sample, please observe sample appearance and shape, such as jaundice,
hemolysis, chylemia , etc.

Caution

Do not use the expired sample, otherwise may lead to inaccurate measurements.

Biological Hazard

Incorrect use of sample can cause infection, do not let your hands contact with the sample.
Be sure to put on protective gloves, clothes, or even goggles if necessary. If the sample
splashes to the skin accidentally, please treat immediately according to the working
standards and consult a doctor.

4.7.2 Application for the routine sample test

When analyzing a normal patient’s sample, you need according to the test application form’s
information to do the sample test setting and patient information registration.

1) Click the icon in main menu to enter the interface, then select the biochemical
items and apply for routine sample test in this interface;

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Figure 4.7.2-1 Normal item test application interface

The main function keys:

【NEW】: Click this button to create a new sample application.

【ADD】: Click Add to complete the application or save the change after applying a new sample test
or modifying the test information of the sample which has been applied.

【COPY】: Copy the applied item list.

【PREDILUTE】: Pre-dilute the sample. For the specific operation, please refer to the chapter 3.9.4
diluted sample test.

【TEST】: Click Test to enter testing system after completing sample application.

2) Input the sample ID in【Sam. ID】;


 Sample ID only consists of Arabic numbers and no more than 4 digital, namely ID range is 1 to
9999.

 The default sample ID is 1. Sample ID could be added automatically by system, and also
entered manually. You cannot use the same sample ID for two different samples, otherwise the
former test results will be covered by the later one.

3) Select the size of cuvette from【Size Of Cup】pull-down list, options include sample cup, test
tube, test tube 1, the default is sample cup.
 If select QC button, that means apply for QC test.

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4) Select the sample placing position from 【Sam. Cup】pull-down list;


System default start test from the No.1 position in sample tray, the user can also select the sample
position according to needs.

Note

Please be sure to place the sample correctly in the applied sample position.

5) Select the virtual sample tray from【Dummy tray】pull-down list;


◆ Sample supports virtual sample tray setting, sample tray allows set 20 virtual sample tray
maximum, but only default one sample tray, it can edit 1320 samples at the same time once.

6) Select the test item or profile item from the item list;
◆ The selected item will be marked with green; And then click it again to return to grey to cancel
this item.

◆ The selected profile item will be marked with blue; And then click it again to return to grey to
cancel this profile item.

◆ If the item cannot be selected, that’s means the calibration is not successful, so cannot perform
the QC test or sample test. Please re-calibration and make sure the calibration is successful.

7) Click ADD button to add the applied biochemical item into the list;
8) Repeat the above operation until complete all the sample application.
If you want to batch apply routine tests, just click the COPY button, and then select the number in the
pop-up copy dialog box, checking the Same Cup to use the same reaction cup, do not click it to use
the different sample cup.

Figure 4.7.2-2 Sample copy interface

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Note

In order to improve the efficiency, the patient basic information such as name, gender, can
edit in the testing process. For the specific operation, please refer to the chapter 6.3.1
Patient information registration.

4.7.3 Start the sample analysis

After apply for routine sample test and correct place the required sample, now you can start testing.

1) Select the List option in routine test application interface;


◆ Make sure the routine sample application is correct, including sample cup position, sample cup
specification and test item.

◆ If the sample application is wrong, please select the wrong sample ID, click DEL button to delete
it.

◆ If the item application has not completes, please select the sample ID and return to routine
sample application interface to add it.

Figure 4.7.3-1 Item application list display interface

2) After confirm the list, please click the TEST button which in the lower-right corner to enter the
test system;
3) In test system, click TEST button to start test, before testing, the system will enter the sample
barcode scanning interface.

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Figure 4.7.3-2 Sample barcode scanning interface

You can scan the sample barcode in this interface, if you don’t need to scan the barcode, just click
Return button to start testing. If you want to scan the barcode, please scan the certain position
sample barcode, and then input the sample position, range is 1 to 79,or directly select the sample
position by mouse, and then the system will scan the selected position’s sample. If you want to scan
the sample barcode in all positions, please click Scan button which behind the 1 to 79.

If you need to add multiple sample positions’ sample barcode, please input the sample position
number, and the click Add button. The scanned sample barcode will display in the right side list.

Note

Before test, please make sure the sample has been correctly selected and placed.

4.8 Emergency sample test

In an emergency situation, emergency sample test is prior to routine sample test.

Biological Hazard

Incorrect use of patient sample can cause infection, do not let your hands contact with the
patient sample. Be sure to put on protective gloves, clothes, or even goggles if necessary.
If the sample splashes to the skin accidentally, please treat immediately according to the
working standards and consult a doctor.

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4.8.1 Application for the emergency sample test

Emergency sample application is suitable for the single emergency sample application, this product
does not provide batch emergency samples application.

1) Click Pause button in test system, as shown in figure 4.8.1-1; to make the instrument in a
suspended state, convenient for user to place the emergency sample.

Figure 4.8.1-1 Test interface

Biological Hazard

Sample adding probe is direct contact with the patient sample, so it is potentially
infectious. Please place the emergency sample after the instrument operation is stopped,
in order to avoid your hand scratched by sample adding probe.

2) Click Go Back button;


The main function keys:

【 Pause 】 : Click this button, and then the system will enter suspended state after complete the
current testing.

【Go Back】: Click this button to return the management program.

【TEST】: Click this button to start the sample test.

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【Emergency exit】: If you have to abort the measurement in processing, click the Emergent exit
key. In this case, measurement is cancel.

【Exit】: After complete the tests, please click this button to exit the test system.

3) Click icon in main menu to enter the emergency sample application interface;

Note

Emergency test interface is very similar to routine sample test interface; please pay
attention to identify the tip icon, so as to avoid confusion.

Figure 4.8.1-2 Emergency sample application interface

4) Input the emergency sample ID in【Sam. ID】;


◆ Sample ID only consists of Arabic numbers and no more than four digital, namely ID
range is 1 to 9999.

◆ You cannot use the same sample ID for two different samples, otherwise the former test
results will be covered by the later one.

5) Select the size of cuvette from【Size of Cup】pull-down list;


6) Select the sample placing position from 【Sam. cup】pull-down list;
Position options including all the emergency positions in sample tray: E1 to E4.

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Note

Please make sure the emergency sample has been correctly placed in the applied
emergency position.

7) Select the test item or profile item from the item list;
8) Click ADD button;
9) Repeat the above operation until complete all the emergency sample application.

4.8.2 Start the emergency sample test

1) Select the List option in emergency sample application interface;


2) After confirm the list, please click the TEST button which in the lower-right corner, and then the
system will pop up operation tip dialog box;

Figure 4.8.2 Confirm emergency operation interface

3) Place the emergency sample in the applied emergency position, and then click OK button;
4) Click Continue button, the system will give priority to emergency sample tests.

4.9 Special sample test

Except for routine sample test, during testing process usually requires sample or item
complementing, dilute sample or retest the abnormal sample.

4.9.1 Sample Complementing Test

Biological Hazard
Incorrect use of sample can cause infection, do not let your hands contact with the sample.
Be sure to put on protective gloves, clothes, or even goggles if necessary. If the sample
splashes to the skin accidentally, please treat immediately according to the working
standards and consult a doctor.

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Caution

Do not use the expired sample, otherwise may lead to inaccurate measurements.

Sample complementing test operations are the same as routine sample test.

1) Click Pause button in test system;


And then the system will enter suspended state after complete the current sample adding operation.

2) Click Go Back button in test system;


3) Please refer chapter 4.7.2 Application for the routine sample test to complete the new sample
complementing;
4) Select the List option, and confirm the sample application information;
5) Place the complementing sample in the setting position;

Biological Hazard

Sample adding probe is direct contact with the patient sample, so it is potentially
infectious. Please place the sample after the instrument operation is stopped, in order to
avoid your hand scratched by sample adding probe.

6) Click TEST button in routine sample application interface to enter the test system;
7) Click Continue button in test system to continue sample testing.

4.9.2 Re-test the sample

After complete the sample test, the system allows retest the sample automatically or manually. But
only allows retest the item which has been tested. Manually retest can be operated in test data
interface; automatic retest can be set according to exceeding linear range or substrate exhaustion.

Warning

The results of retest item will cover the original test results.

4.9.2.1 Manually retest the sample

After test, if you find any abnormal test results in test data interface, and then this sample can be
manually retested

1) Click icon in main menu to open the registration interface;

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Figure 4.9.2.1-1 Sample registration interface

The main function keys:

【Evaluate】: Edit item results or add other item’s results into the selected sample ID.

【QC Output】: Display the QC test result in text way.

【SAVE】: Save the edited sample information.

【DEL】: Delete the selected test results or sample ID.

【ReCheck】: Retest the selected sample.

【PRINT】: Print the selected sample test results.

【PrintPreview】: Preview the selected sample test results.

2) Select the sample ID which needs to retest from the sample ID list;
3) Click Recheck button which at the bottom of this interface to open the item retest dialog box;

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Figure 4.9.2.1-2 Item retest interface

The main function keys:

【PREDILUTE】: Click this button to set the item dilution ratio.

【Select】: Click this button to select the item which needs to retest.

【Undo】: Withdraw the retest or pre-dilution setting of the selected item.

【CHECK】: Click this button to start the sample retest.

【Cancel】: Cancel the current settings and return to the sample registration interface.

4) Select the item which needs to retest, and then click Select button;
The selected item will be marked with blue √; Click Undo button to cancel the item retest.

5) Select the item which needs to pre-dilution retest, and then click PREDILUTE button, and then
the system will pop up the following dialog box;
Input the dilution ratio in this dialog box, and then click ENTER button.

◆ Pre-dilution range is any integer between 2 to 250.

◆ If pre-dilution operation is not need, just skip this step and continue to perform the next
step.

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Figure 4.9.2.1-3 Pre-dilution dialog box

6) Select the sample tray which the retest sample is placed in【Dummy Tray】;
Virtual sample tray including: D1 to D20.

7) Select the size of cuvette from【Size of Cup】pull-down list;


8) Select the retest sample placing position from 【Sam.Cup】pull-down list;
9) Click CHECK button which in the lower-right corner of item retest dialog box to start retest.

4.9.2.2 Automatic retest after exceeding linear range

Through normal item parameter setting interface to set the automatic retest condition: exceeding
linear range. After the sample test, the system will judge the test results and when the results are
exceeding linear range, and then the system will automatic retest this item. The system provides two
automatic retest settings: Sample retest and Pre-dilution retest.

1) In main interface, click the icon to open the normal item parameter setting
interface;
2) Select Normal value range setting option;
3) Select the item which needs to automatic retest after exceeding linear range from the left side
item list;
4) Input the linear range in【Reagent linear range】;
Linear range of determination results and reaction degree R (reaction degree: Reaction solution
absorbance and the change rate of absorbance), it shows the measurable range of instrument. User
should according to the reagent specification to set, and the system will automatically mark the
results exceeding the range as non-linear.

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5) Check the Automatic retest after exceeding linear range check box;
◆ There will appear sample retest and pre-dilution retest options, please set according to need.

◆ If you select Sample retest, for the item result exceeding the linear range, the system will
automatic retest it.

◆ If you select Pre-dilution retest, please input the dilution ratio in【Dilution ratio】, for the item
result exceeding the linear range, the system will automatic according to the set dilution ratio to
retest it. Pre-dilution range is any integer between 2 to 250.

6) Click SAVE button to save the settings.

4.9.2.3 Automatic retest when substrate exhaustion

In rate method, the user can through the parameter item interface to set the substrate exhaustion
judgment method and automatic retest when substrate exhaustion. After the sample test, the system
will judge the test results and when the results appear substrate exhaustion, and then the system will
automatic retest this item. The system provides two automatic retest settings: Sample retest and
Pre-dilution retest.

Note

Substrate exhaustion setting is only effect on rate method.

1) In main interface, click the icon to open the normal item parameter setting
interface;
2) Select Normal value range setting option;
3) Select the item which needs to automatic retest when substrate exhaustion from the left side
item list;
4) Check the Automatic retest when substrate exhaustion check box;
◆ There will appear sample retest and pre-dilution retest options, please set according to need.

◆ If you select Sample retest, after substrate exhaustion, the system will automatic retest this
item.

◆ If you select Pre-dilution retest, please input the dilution ratio in【Dilution ratio】, after substrate
exhaustion, the system will automatic according to the set dilution ratio to retest it. Pre-dilution
range is any integer between 2 to 250.

5) Set the substrate exhaustion judgment method;


Please refer chapter 7.2 Substrate exhaustion judgment method to set the substrate exhaustion
judgment method.

6) Click SAVE button to save the settings.

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4.9.3 Sample dilution test

Due to the patient's condition difference, for some samples, the test results of individual items are
relatively high, so you can manually or automatic dilute the sample to certain degree, or for certain
item, dilute the sample to certain degree, and then start test. After the sample testing is completed, if
discover some results are exceeding the reference range or identify abnormal, then you can through
the manually retest method to dilute the sample and retest it. For more information about retest
(sample retest and pre-dilution retest), please refer to chapter 4.9.2 Sample retest.

This section is mainly introduces how to set the dilution ratio.

1) Please according to the operation steps in chapter 4.7.2 Routine sample application to apply
sample test;

2) Select the sample which needs to dilute from the list option;

3) Click PREDILUTE button to enter the dilution ratio setting interface;

Figure 4.9.3 Dilution ratio setting interface

4) Input the dilution ratio in【Ratio】;

Pre-dilution range is any integer between 2 to 250.

5) Click ENTER button to complete the pre-dilution setting;

6) Click RETURN button to return the routine sample test application interface;

7) Click Test button to enter the test system;

8) In test system, click Test button to start sample test.

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4.10 Test status and stop

During the test process, the user can through the test system to check the situation in the process of
reaction.

Figure 4.10 Test interface

Reaction tray color identification meaning is as follows:

Color Meaning

Green Adding reagent R1

Red Adding sample

Light red Adding reagent R2

Blue Test has been completed

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4.10.1 Check the test status

1) Click the Cuvette option which in the right side of test system to check the reaction cup, you can
see the reaction cup’s reagent information in this interface, including test items, incubation time,
test points, absorbance and test results, etc.

Figure 4.10.1-1 Reaction cup state interface

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2) Click the Sample option which in the right side of test system, and then select the sample ID
which you want to check, and then you can see all the reagent information under that sample ID.

Figure 4.10.1-2 Sample information interface

3) Click the Reagent option which in the right side of test system, and then select the item which
you want to check, and then you can see all the test results and normal high and low value under
that reagent.

Figure 4.10.1-3 Reagent information interface

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4) Click the Test option which in the right side of test system, to check the applied test list, and then
you can see test results of each test item and their normal high and low value.

Figure 4.10.1-4 Test item information interface

5) Click the Query Reagent option which in the right side of test system, to check the reagent
position, remaining volume and measurable number. If the remaining volume is insufficient will
be displayed in red.

6) Click button which in the right side of alarm column to enter the instrument status
surveillance.

◆ Button displays green, indicates everything is normal.

◆ Button flashes yellow, indicates instrument or test is abnormal. Please click the button to check
the alarm information.

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Figure 4.10.1-5 Alarm information display interface

The main function keys:

【Clear Info】: Click this button to clear the current alarm information.

【Close Alarm】: Click this button to close the alarm sound.

【RETURN】: Return to test system interface.

4.10.2 Pause operation

During the test, if appear the situations of reagent, detergent or distilled water is insufficient, or waste
solution is too much, please click “Pause” button in test system, and then perform the related
operations after the system stop adding sample. After that, click Continue button to continue to test.

4.10.3 Exit

After all the samples have been tested, please click Exit button in the test system to exit, test data
will be saved automatically.

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4.10.4 Emergency exit

After perform emergency exit operation during the test, the instrument will terminate all test action,
and cancel all sample application, so please perform with cautious. Unless special circumstances,
such as instrument malfunction, URIT do not recommend using this function. If necessary, you can
perform the emergency exit operation no matter what status the instrument is.

Click the Emergency exit button which in the left bottom of test system, and then click Confirm in
the pop up dialog box. And then the system will cancel all the unfinished sample tests.

Note

If you perform emergency exit operation, for the samples which have complete the test, the
system will automatically save the test results.

4.11 Routine maintenance

After complete all the tests, please according to chapter 9.3 Daily maintenance to do the instrument
maintenance.

Daily maintenance items including:

1) Check distilled water bucket

2) Check waste solution bucket

3) Check detergent bucket

4) Check reagent/sample injection pump

5) Check/Rinse sample adding probe and stirrer

6) Check print/printing paper

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4.12 Power off

After complete all the tests, please perform end operations for the biochemical analyzer, start the
instrument cleaning function, exit system and shut off the power. At the same time after power off,
you still need to do the related maintenance operations, in order to convenient for next use.

4.12.1 Power off

1) Confirm the system is in standby mode;

2) Click which in the right side of main interface, and then click Confirm button in the
pop-up dialog box to exit the biochemical management system;

Figure 4.12.1 maintenance before shutdown

3) Turn off the power supply in the following order:

a) Printer power supply

b) Computer power supply

c) Instrument test power supply (The right side of the instrument)

d) Instrument main power supply (The right side of the instrument)

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Note
1) The power supply of reagent refrigeration system is separate from the instrument test
power supply, so in the case of main power is turned on, refrigeration system will
always in working state.

2) If you don't use the instrument for a long time, please close the switchboard switch.

4.12.2 24 hours standby

If you need to keep the instrument in 24 hours standby mode, please do not turn off the main power
supply when perform the shutdown operation (Please refer to chapter 4.12.1 Power off), which
keeps the reagent tray refrigeration function. And then turn on the instrument test power supply when
you need to run the system.

4.12.3 Operation after Power Off

Biological Hazard
1) Some substances contained in reagent, QC solution, standard solution, detergent and
waste solution are regulated by discharge standards and pollution control
regulations, waste must be disposed according to the relevant environmental
protection regulations, and consult relevant reagent manufacturers or distributors.

2) Be sure to put on protective gloves, clothes, or even goggles if necessary when


dispose waste solution.

1) In reagent tray, cover the reagent bottle cap.

Note

If you turn off the instrument main power supply, then the reagent tray refrigeration
function will lose efficacy, then reagents must be stored in refrigerator.

2) Remove the calibration solution, control solution and sample from the sample tray.

3) Check the analyzer host bench whether there is a stain. If so, please wipe it clean with a clean
soft cloth.

4) Check waste solution bucket. If the waste solution is too much, please empty the waste solution
bucket.

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CHAPTER 5 OPERATING PRINICPLE

This product is a fully automatic, discrete, surname–elect style clinical biochemical analyzer, fully
controlled by computer. With the aid of all kinds of calculation method and measuring principles, it
can quickly finish various tests. System data analyzing and calculating process is shown in the
following figures:

A/D Value

Absorbance

Reaction solution absorbance and the change rate of absorbance

Calibration parameter

Test results QC results

QC judgment

First the system through photoelectric conversion, signal amplification and A/D conversion to test the
intensity of light, and then according to the intensity of the light to calculate the reaction solution
absorbance and the change rate of absorbance, and then according to the change rate of
absorbance to calculate the calibration parameters. Finally, according to QC test to calculate the QC
results, and determines whether the system is stable, and then according to the calibration
parameters to calculate the sample test results.

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5.1 Principle

The definition of absorbance:

When a bunch of collimated monochromatic light which intensity is I0 get through the cuvette(which
the concentration of absorptiometic matter is C and optical path is L), as shown in the figure below,
some of the photons are absorbed, light intensity I0 is attenuate to I, then the absorbance of this
solution A is equal to:

I
A   lg
I0

Among them:

I 0 ---Input intensity.

I ---Output light intensity.

I
---Light transmittance.
I0

Lambert’s Beer Law:

A  ε CL

The following formula can be deduced:

I
 lg = εCL
I0

Among them:

C: The concentration of solution.

L: The optical path of cuvette (Unit: cm).

ε: Light absorption coefficient.

Molar absorption coefficient: The recommended term for the absorbance for a molar concentration of
a substance with a path length of l cm determined at a specific wavelength.

Specific absorptivity: Absorbance (of light) per unit path length (usually the centimeter) and per unit
of mass concentration.

Measure I, I0, and L, and then calculate the concentration C according to the formula above.

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5.2 Test methods

Automatic biochemical analyzer is based on Lambert’s Beer Law to analyze and calculate, the basic
calculation methods including:

1) Endpoint method (One point endpoint method)

2) 2-point endpoint method (Double reagent endpoint method)

3) Two point-speed method (fixed-time method)

4) Rate method (Kinetic method)

5.2.1 Endpoint method

Endpoint method: Reaction reaches equilibrium after a period of reaction, because the equilibrium
constant of reaction is very big, then all the substrate (sample) can be thought transform into product,
and the absorbance of reaction solution is not increase (or decrease) any more, and the increase (or
decrease) of absorbance level is directly proportional to the concentration of the test sample. This
kind of method is often called "end point" method, and to be more precise should become balanced
method, which is the most ideal type of analysis.

End point method is insensitive to small change of reaction conditions (such as enzyme amount, PH,
temperature, etc.), as long as this change will not affect the reaction reaches equilibrium within a
certain amount of time.

Computing method:

Endpoint method (single reagent) reaction curve as shown in the figure below:

Figure 5.2.1 Single reagent endpoint method reaction curve

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R1: Adding the first reagent

S: Adding sample

a: Absorbance test start point

b: Absorbance test end point

1~3: Blank absorbance test point for reagent 1

The system will record the absorbance change since add R1, until the end of the longest reaction
time.

 Reagent parameter setting:

S to a: Incubating time of the first reagent

a to b: Test points

 Result calculation:

C (A1 - A0) K
Among them:

C: The concentration of reactant

K: Calculation factor

A1: The average absorbance from a to b

A0: The average absorbance of 1~3 before add S, that is the R1 blank

λ:Volume correction factor

 The calculation of volume correction factor

Volume correction factor includes λ1, calculation method as follow:

VR1
1 
VR1  VS
Among them,

VR1: Volume for the first reagent

VS: Volume for the actual added sample

Caution

Above reagent blank absorbance test point is defaulted by the system, for immune reagent
item, it can be set according to the need.

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5.2.2 2-Point endpoint method

Selecting the first absorbance (Aa) before reaction, and selecting the second one (Ab) when the
reaction is balanced or has completed, the difference between two absorbances are used for
calculating result.

Formula: CU=( Ab-Aa×λ)×K

K: Absorbance coefficient (standard factor)

Computing method:

2-point Endpoint Method is mainly used for double reagent endpoint method calculation, and the
computing method of sample blank and volume correction factor have been added, the basic
principle is the same as the endpoint method, the reaction curve is shown in figure 5.2.2:

Figure 5.2.2 Double reagent 2-point endpoint method reaction curve

R1: Adding the first reagent

S: Adding sample

R2: Adding the second reagent

a: Absorbance test start point

b: Absorbance test end point

c~d: Special blank test start point, usually take five test points, if the set time is not enough for 5
test points, then the system will automatically select blank test points according to time.

1~3: Blank absorbance test point for reagent 1

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The system will record the absorbance change since add R1, until the end of the longest reaction
time.

 Reagent parameter setting:

S to R2: Incubating time of the first reagent

R2 to a: Incubating time of the second reagent

a to b:Test points

 Result calculation:

[ A2 - A0)- ( A1  A0 )  1 ]  K
C (
C: The concentration of reactant

K: Calculation factor

K1: Volume correction factor

A1: The average absorbance from c to d, and that is the sample blank

A2: The average absorbance from a to b

A0: Reaction cup water blank, the instrument will real-time read the reaction cup water blank

VR1  VS
1 
VR1  VS  VR 2
VR1: Volume for the first reagent

VS: Volume for the actual added sample

VR2: Volume for the second reagent

5.2.3 Two point-speed method (fixed-time method)

Two point-speed methods is also known as primary kinetic method and fixed time method, is another
form of dynamic method. In a certain reaction time, reaction rate is directly proportional to the
substrate concentration in first power, that is: v=k[S]. Due to the substrate is consuming constantly,
so the reaction rate is constantly decreasing, so the absorbance change is more and more small.
This kind of reaction will take a very long time to reach equilibrium, so theoretically you can monitor it
at any time, but due to the complexity of serum components, reaction is complex in the start point, so
please wait until the reaction into stable reaction period.

C=(Ab—Aa)/(b - a)×C

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Computing method:

Two point-speed method reaction curve as shown in the figure below:

Figure 5.2.3 Two point-speed method reaction curve(single reagent and forward reaction)

R1: Adding the first reagent

S: Adding sample

a: Absorbance test start point

b: Absorbance test end point

The system will record the absorbance change since add R1, until the end of the longest reaction
time.

 Reagent parameter setting:

S to a: Incubating time of the first reagent

a to b: Test points (time)

 Result calculation:

 A  Aa 
C   b   K
 tb  t a 
C: The concentration of reactant

K: Calculation factor

Aa: The absorbance in a point

Ab: The absorbance in b point

ta: Time to a point

tb: Time to b point

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Note

Double reagent calculation is the same as the single reagent.

5.2.4 Rate method (kinetic method)

Rate method is also called the zero order dynamics method, reaction rate is directly proportional to
the substrate concentration in zero power, so that is nothing to do with the substrate concentration. In
the process of the reaction, reactant can produce a product in constant speed, and cause the
absorbance of test solution evenly decrease or increase under a certain wavelength, and the
decrease or increase speed is directly proportional to the activity or concentration of the analyze.

Rate method is also known as the continuous monitoring method, it is mainly used for the
determination of enzyme activity. Enzymes are a kind of special protein which produced by living
organisms and have catalytic effect in vivo and in vitro, and almost all of the metabolic reactions in
vivo are enzyme catalysis. Enzyme catalytic efficiency is very high and very unstable. The
concentration change of enzyme in the human body can reflect a lot of diseases. At the same time,
enzyme content is very low, so in addition to the immunological method, it cannot be tested directly,
and you can only measure the material changes within a certain time in the process of catalytic
reaction, namely enzymatic reaction rate, or enzyme activity. And you can through measuring the
concentration decrease of substrate or the concentration increase of product, to track the process of
substrate conversion into product in enzymatic reaction. Enzymatic reaction process can be divided
into several periods. Delay period: Early stage of the chemical reaction, the change of substrate and
product are not obvious, this period lasts few seconds to minutes; zero order reaction period: The
period which the change of substrate and product and time are in a straight line, and the product is
produced in constant speed; first order reaction period: The period which the reaction rate is continue
decreasing.

C=ΔA×F=ΔA×Vt/Vs×1000/ε

C: Concentration of enzyme activity, the unit is the U/L

F: Conversion factor

Ε: Mmol extinction coefficient

Vt: Total reaction volume

Vs: Sample volume

ΔA: Change of absorbance per minute

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Computing method:

Rate method reaction curve as shown in the figure below:

Figure 5.2.4 Rate method reaction curve(single reagent and negative reaction)

R1: Adding the first reagent

S: Adding sample

a: Absorbance test start point

b: Absorbance test end point

The system will record the absorbance change since add R1, until the end of the longest
reaction time.

 “Reagent parameter setting”:

S to a: Incubating time of the first reagent

a to b: Test points (time)

 Result calculation

C  Aab / min K
C: The concentration of reactant

K: Calculation factor

Aab / min
: The absorbance change rate from c to d

Note

Double reagent calculation is the same as the single reagent.

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5.3 Calibration

Test the absorbance change rate of the known concentration calibration solution, and then according
to the computational relationship between concentration and change rate (Calibration method), to
calculate the coefficient of the computational relationship (Calibration coefficient), and then
determine the specific operation expression between concentration and change rate. So the routine
sample can be tested according to the specific operation expression and the absorbance change
rate.

5.3.1 Introduction

Calibrate the test items by calibration reference materials, this is the necessary condition to provide
accuracy and reliability measurement data for clinical. Calibration is under specified conditions to test
the control solution, and then compare the test results with control solution reference range. The test
items which tested by clinical biochemical analyzer must calibrate by calibration reference materials.

Calibration process: Through a certain concentration calibration substance, and using the product of
chemical reaction to determine the light absorption of reaction solution for specific wavelength, and
then change the absorbance variation to concentration value. Usually is according to the relationship
between absorbance value and concentration (Calibration method), to determine the calculation
formula or to draw the standard curve.

Calibration method is mainly divided into two categories: linear calibration and nonlinear calibration.
The linear calibration is divided into two kinds, one kind is completely linear, the other is piecewise
linear.

1) Completely linear calibration method: A  C  K  b ,including: Single point linear calibration

method (also called factor method), two points linear calibration method (also called linear
method) and multipoint points linear calibration method (3 points and above) (also called linear
regression method)

2) Piece-wise linear calibration method: . Polygon method belongs to the

piece-wise calibration method.

3) Nonlinear calibration method: Parabola, Logistic-Log 4P, Logistic-Log 5P, Exponential 5P, Spline,
etc.

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Introductions:

1) Endpoint method, 2-point endpoint method, two point-speed method and rate method can be
corresponding to above calibration method.

2) In the calibration formula:

A: Absorbance

C: The concentration of calibration solution

K、b: Calibration parameter

Calibration solution is the standard solution, which the concentration has been accurate measured.

5.3.2 Liner calibration

1) Single point linear calibration method

Calibration formula: A  C  K

Calibration parameter: K,

Calibration curve as shown in figure 5.3.2-1:

A Mark

C Mark

Figure 5.3.2-1 Single point linear calibration

Single point linear calibration only needs to provide a standard substance. Most enzymology items
can directly input factor (input value F=1/K) instead of calibration.

A
Concentration calculation: C  or C  A  F
K
K: Calibration parameter; F: Input factor number.

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2) Two points linear calibration method

Calibration formula: A  C  K  b

Calibration parameter: K and b

A2  A1 A2  A1
K b  A1  ( )  C1
Among them, C 2  C1 , C 2  C1

Calibration curve as shown in figure 5.3.2-2:

A
K
A2

A1

C1 C2

Figure 5.3.2-2 Two points linear calibration

Two points linear calibration needs to provide two standard substances.

C1: The concentration of calibration solution 1;

C2: The concentration of calibration solution 2;

A1: The absorbance of calibration solution 1;

A2: The absorbance of calibration solution 2.

Ab
C
Concentration calculation: K , K and b are calibration parameters.

3) Multipoint points linear calibration method

Calibration formula: C  K  A  b

Calibration parameter: K and b

Multipoint points linear calibration needs to provide n(n ≥3) standard substances.

Ci: The concentration of calibration solution i;

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Ai: The absorbance of calibration solution i.

Using the linear least square method to solve K and b:

n n n

C A i i  ( C i )( Ai ) / n
K i 1
n
i 1
n
i 1

 C i  ( C i ) 2 / n
2

i 1 i 1

 n n n

n   C i Ri  (  C i )(  A i ) / n  n
b  ( Ai ) / n   i 1
n
i 1
n
i 1
 ( C i ) / n
  i 1
 
2 2
i 1
 C i  ( C i ) / n 
i 1 i 1

4) Polygon method

Calibration formula:
C x  K n  ( Ax  An )  Cn
Among them, 3≤n≤8

Calibration curve as shown in figure 5.3.2-3:

A4

A3

A2

A1

C1 C2 C3 C4 C

Figure 5.3.2-3 Polygon method

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Polygon method needs to provide n(n ≥3) standard substances, on


Ci  C x  Ci 1 interval, using
two points calibration method to calculate Ki and bi.

Concentration calculation: First according to Ax determine the interval of Cx, and then according
Ax  b
Cx 
to
K x to calculate.

5.3.3 Nonlinear calibration

1) Porabola

Calibration formula: A  aC 2  bC  c

Calibration parameter: a, b and c

Porabola method needs to provide at least three standard substances, to solve the ternary system of
linear equations.

Calibration curve as shown in figure 5.3.3-1:

C1 C2 C3 C4

Figure 5.3.3-1 Parabola

 b  b 2  4ac
Concentration calculation: C 
2a

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2) Logistic-Log 4P

1
A  A0  K
Calibration formula: 1  exp[ (a  b ln C )]

Calibration parameter: A0, a, b and c

A0: The absorbance of calibration solution which concentration is zero

(If the user does not provide zero concentration standard substance, then the A0 is 0. This method
requires at least four different concentrations of standard substances, using a third-party library
levmar for fitting to solve.)

Calibration curve as shown in figure 5.3.3-2:

C0 C1 C2 C3 C

Figure 5.3.3-2 Logistic-Log 4P

K
 a  ln( )
A  A0
Concentration calculation: C  exp( )
b
3) Logistic-Log 5P

1
A  A0  K
Calibration formula: 1  exp[(a  b ln C  cC )]

Calibration parameter: A0, K, a, b and c .

A0: The absorbance of calibration solution which concentration is zero

(If the user does not provide zero concentration standard substance, then the A0 is 0. This method
requires at least five different concentrations of standard substances, using a third-party library
levmar for fitting to solve.)

Concentration calculation: Using the dichotomy, the accuracy is one over one thousand.

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4) Exponential 5P

Calibration formula:
A  A0  K  exp[ a ln C  b(ln C ) 2  c(ln C ) 3 ]

Calibration parameter: A0, K, a, b, c

A0: The absorbance of calibration solution which concentration is zero

(If the user does not provide zero concentration standard substance, then the A0 is 0. This method
requires at least five different concentrations of standard substances, using a third-party library
levmar for fitting to solve.)

Calibration curve as shown in figure 5.3.3-3:

C1 C2 C3 C4 C5 C

Figure 5.3.3-3 Exponential 5P

Concentration calculation: Using the dichotomy, the accuracy is one over one thousand.

5) Spline

Calibration

C  C i  A0i  ai  (C  C i )  bi  (C  C i ) 2  ci  (C  C i ) 3  A
formula:

Calibration parameter: There are 4i parameters, A0i, ai, bi, and ci.

This method requires 2 to 6 different concentrations of standard substances, using a third-party


library levmar for curve fitting to solve. Because it is piecewise fitting, the fitting degree is the highest
in all of the nonlinear calibration.

Concentration calculation: Using the dichotomy to calculate

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5.4 Quality control judgment method

5.4.1 Introduction

System uses Levery Jennings and Westgard quality control method to judge the QC results for all the
test items. Since each test item may set to use one or more than one control solution, therefore, the
system uses different rules to judge different conditions.

5.4.2 Levey-jennings method

This method belongs to the first generation quality control method; the specific rules are as follows:

1-2S rule: Any quality control result exceeding mean value ±2SD, judged to be out of control.

1-3S rule: Any quality control result exceeding mean value ±3SD, judged to be out of control.

5.4.3Westgard method

The ±2SD and ±3SD control methods of Levey-Jennings have obvious differences between error
detection sensitivity and out of control error recognition specificity, but Westgard method is combine
them skillfully, and introduce other quality control rules to form multiple rules control method. Purpose
is to improve the efficiency of control, both the error detection has good sensitivity, and the
recognition of out of control error has good specificity.

◆ In multiple rules control method, Westgard suggests use two control solution, high concentration
and low concentration, to form a control range.(You can also just use one control solution, but
there are a lot of limitations)

◆ Draw seven parallel lines on the quality control chart: mean value, mean value+1S, mean value
-1S, mean value +2S, mean value -2S, mean value +3S and mean value -3S,convenient for
observation.

◆ In Westgard method, the 1-2S is only as the warning rule, not the out of control rule. Make full
use of it has good sensitivity on error detection, but also limits its weakness on error specificity is
poor.

It only points out the possible problems, but still needs through a series of sequence checking, and
then judging by other rules.

◆ After selection, the 1-3S, 2-2S, R-4S, 4-1S and 10X rules are listed as out of control rules, so it
will both sensitive to random errors and system error. So the multiple rules control method is
greatly improving the control efficiency.

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As shown in the following table:

Quality control rules Interpretation of the results

1-2S Warning

1-3S Random error

2-2S System error

R-4S Random error

4-1S System error

10x System error

Figure 5.4.3-1 Westgard multiple rules control method

1) 1-2S rule

Because the 1-2S is only as the warning rule, not the out of control rule. If the test results of this
batch are both within the range of mean value ±2S, then it indicates the test results of this batch are
both under control. If there has one QC result exceeding the range of mean value ±2S(Do not include
the results just on the mean value ±2S line), then it indicates the test results of this batch may have
problems, need to check, but is only a warning, not out of control. And then please according to the
quality control method to check whether there are the following out of control performances.

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Figure 5.4.3-2 1-2s Quality control rule

2) 1-3S rule

If there has one QC result not only exceeding the range of mean value ±2SD, but also exceeding the
range of mean value ±3SD, judged to be out of control, it belongs to the random error.

Figure 5.4.3-3 1-3s Quality control rule

3) 2-2S rule

2-2S rule:

The test results of two control solution from the same batch are exceeding the control range of mean
value ±2SD. Or the test results of same control solution from two continuous batches are both
exceeding the control range of mean value ±2SD, judged to be out of control, it belongs to the
system error.

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Figure 5.4.3-4 2-2s Quality control rule

4) R-4S rule

The test results of two control solution from the same batch are exceeding the control range of 4SD,
one is exceeding mean value +2SD, the other is exceeding mean value -2SD, judged to be out of
control, and it belongs to the random error.

Figure 5.4.3-5 R-4s Quality control rule

5) 4-1S rule

4-1S:

① Including this warning QC result, the three previous QC results of this control solution and this
QC result are both exceeding the control range of mean value ±1SD.

② Including this warning QC result, the previous QC result of this control solution is exceeding the
control range of mean value ±1SD, and the two QC results of another control solution are both
exceeding the control range of mean value ±1SD.

Judged to be out of control and it belongs to the system error.

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Figure 5.4.3-6 4-1s Quality control rule

6) 10X rule

10 consecutive QC results are fall in the same side of the mean value (higher or lower than the mean
value, for the size of the deviation does not require), judged to be out of control, and it belongs to the
system error.

Figure 5.4.3-7 10x Quality control rule

5.4.4 Quality control judgment precautions

When quality control results appear the above situation, please pay attention to the following
matters:

1) 1-2S is warning rules, not out of control rules. When test result is exceeding the control range of
mean value ±2SD, you do not need to retest it immediately, please check whether it really out of
control.

2) Even it really out of control, please do not delete the QC results which are exceeding the control
range of mean value ±2SD, because after all these points are deleted, the results range will
become small, and then the S of next month quality control chart will become small too; And then
the quality control range will become unreal, increase the difficulty of control.

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3) So when appears 1-2S, please first check whether it really out of control. And when it really out
of control, retest the control solution, and check out of control reason, and then please retest the
patient sample after correct the error.

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CHAPTER 6 DATA PROCESSING

This chapter is mainly introduces how to view, edit and print various test data and reaction curve, and
data backup.

6.1 Check the calibration result

You can check the biochemical item’s calibration parameters and calibration formula, and all the
calibration parameters and results within a period of time through the calibration result interface. You
can also check the item’s calibration curve and test curve, and edit and recalculate the calibration
parameters.

6.1.1 Check the calibration curve

The minimum concentration and the maximum concentration of calibration solution was divided into
several parts by the calibration curve, and then draw a curve according to the absorbance of each
parts, reflects the algorithm relationship between concentration and absorbance. For the linear
calibration test, calibration curve is a straight line; and for nonlinear calibration test, calibration curve
is a curve.

1) In main menu, click icon to enter the normal parameter setting interface;

2) Select the item which needs to check the calibration curve from the left side item list;

3) Select Multiple standard values setting option to enter the multi-point calibration result
interface;

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Figure 6.1.1 Check calibration curve interface

6.1.2 Check the reaction curve

Reaction curve: Draw a curve according to the absorbance of reaction solution (which mixed by
calibration solution and reagent) in each point from entire test cycle, it reflects the absorbance
relationship between dominant wavelength and complementary wavelength.

How to check the reaction curve:

1) In main menu, click Data processing→Analytical Curve icon to enter the interface;

2) Click Standard option button to display the calibration reaction curve;

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Figure 6.1.2 Test curve display interface

3) Input the test data in Test date, and then check the relevant item’s test curve.

This interface is default to display the current test curve.

4) Select the relevant button to perform the needed operation.

【Enlarge】: Magnify the precision of the y coordinate.

【Small】: Reduce the precision of the y coordinate.

【Calculate】:According to the user sets start point and end point to recalculate the test curve.

【Result】: Refresh the interface to obtain the data.

【SAVE】: Save the recalculated test curve.

【RETURN】: Return the calibration result query interface.

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6.1.3 Edit the calibration result

For linear or nonlinear calibration test, if it is found that the calibration results are higher or lower than
expected, the system allows to modify the test results, to ensure that the results are match the
expected values. When edit the calibration results, please make sure you have sufficient permissions
and the system is in standby mode.

The calibration result modification methods of linear and nonlinear are different. For linear calibration
test, direct modify the standard factor (K value); for nonlinear calibration test, you need to enter the
calibration curve interface to modify the absorbance of calibration solution.

(1)For linear calibration test:

1) In main menu, click icon to enter the normal parameter setting interface;

2) Select the item which needs to edit the calibration results from the left side item list;

3) Input the wanted results in【Standard factor】;

4) Click SAVE button.

(2)For nonlinear calibration test:

1) In main menu, click icon to enter the normal parameter setting interface;

2) Select Multiple standard values setting option to enter the multi-point calibration result
interface;

3) Modify the absorbance of relevant calibration solution;

There are two columns, from left to right respectively are calibration solution concentration and
calibration solution absorbance.

Figure 6.1.3 Modify calibration results interface

4) Click SAVE button.

System will automatically according to the revised absorbance to calculate the calibration results.

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6.2 Check the QC result

After the QC tests, quality control test results and the quality control chart can be viewed in QC data
interface. Please according to chapter 5.6 Quality control judgment method to judge the QC
results.

6.2.1 Daily QC Data

Within-day QC is to check the data measured within a day.

1) In menu bar, click Biochemical test→Biochemical QC management→Daily QC data, to enter the


interface;

Figure 6.2.1 Daily QC data interface

2) Select the QC test date from the【Date】;

Then the QC sample test results under that day will be displayed in the right side QC data list.

3) Select the following button to perform the corresponding operation:

【PRINT】:Print the test results of selected QC batch number.

【Print Preview】: Preview the selected QC results.

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6.2.2 Check the QC Curve

1) In menu bar, click Biochemical test→Biochemical QC management→QC Data Chart, to enter


the interface;

Figure 6.2.2 QC chart analysis interface

2) Select Dynamic or standard QC chart to check the dynamic quality control chart and standard
QC chart;

 Dynamic quality control chart: Software according to the daily test data automatically to calculate
the item target value (average) and SD value, and then automatic draw a QC chart.

 Standard QC chart: Software according to the set up target value (average) and SD value in
Control solution setting interface to draw a QC chart.

3) By selecting QC rules, view the related QC chart. More information about QC rules, please refer
to chapter 5.6 Quality control judgment method.

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6.2.3 Check the reaction curve

1) In main menu, click Data processing→Analytical Curve to enter the interface;

2) Click QC option button to enter the QC chart display interface;

Figure 6.2.3 QC test curve display interface

3) Input the test data in Date, and then check the relevant item’s test curve.

This interface is default to display the current test curve.

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6.2.4 Edit the QC Result

Modify the QC results:

1) In menu bar, click Biochemical test → Biochemical QC management → QC Data, to enter the
interface;

Figure 6.2.4 QC data processing interface

2) Select the item which needs to modify the QC results from the left side Item List;

3) Input the modified value to the QC Value input box;

4) Click SAVE button.

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6.3 View and handle the sample result

After the analysis, you can through registration interface to view and handle the test results of routine
sample and emergency sample. Sample registration interface displays sample test results and
provides the function of edit the patient information or results.

6.3.1 Patient information registration

You need to input the patient information during or after the sample test, including: sample ID, patient
name, gender, age, Patient No, hospital number, sample type, inspection department, clinician and
clinical impression, in order to output the complete inspection report. There are two ways for patient
information registration, one is registers the information in the process of test, the other is registers
the information after finish the test. In a massive sample testing, registers the patient information in
the process of test will help you improve the working efficiency.

You can view and edit the sample information, no matter what status the system is in.

1) Return to main interface;

◆ Registers the information in the process of test: Click return to management process button in
test system.

◆ Registers the information after finish the test: Click Exit button in test system.

2) Click icon, to enter Register interface;

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Figure 6.3.1 Sample registration interface

3) Input the sample test date behind Date which in the upper left corner;

The test results under that date will be displayed.

4) Select the sample ID which needs to register the patient information from the sample ID list;

5) Input the patient inspection report make date in【Report Date】;

6) Input the patient test barcode in【Hospital No.】;

7) Input the selected sample ID in【Sample ID】;

Note

In the process of sample registration, you must ensure that the sample ID is corresponding to
the actual sample.

8) Input the patient name in【Name】;

9) Select the patient's gender from the【Sex】pull-down list;

◆ Options include: Male, female, Null, The default is Null.

◆ If the patient is child, please check the Child option.

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10) Input the age of the patient in the first box of【Age】, and then select the unit of age from the
second box;

Age units including: years, months, days, hours and minutes, the default is years.

11) Please according to the patient actual conditions to input the Lab ID, Inpatient ID and Bed No.;

12) Select the test sample type from the【Sample type】pull-down list;

◆ Options include: serum, urine, fasting blood glucose, 2-hour post-meal blood glucose,
cerebrospinal fluid, pleural fluid, and other.

13) Select the inspection department from the【Department】pull-down list;

◆ The user can according to need to increase the inspection department. For specific operation,
please refer to chapter 3.5.2.2 Inspection department setting.

14) Select the patient's clinician from the【Doctor】pull-down list;

◆ The user can according to need to edit clinician. For specific operation, please refer to chapter
3.5.2.3 Clinician setting.

15) Input the patient's clinical impression in【Symptom】;

16) After you complete the patient registration information, please click SAVE button, and then the
system will directly into the next sample ID patient registration information interface;

6.3.2 Check the reaction curve

Sample result’s reaction curve: Draw a curve according to the absorbance of reaction solution (which
mixed by sample and reagent) in each point from entire test cycle, it reflects the absorbance
relationship between dominant wavelength and complementary wavelength.

The lab can use the reaction curve to check the test data’s test curve, and then through check the
test curve to analyze the test data.

1) Click menu bar Data processing→Analytical Curve to enter the interface;

This interface has sample, standard and QC three options; the default is normal sample test curve
display interface;

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Figure 6.3.2 Sample test curve display interface

2) Select the sample ID which you want to check the reaction curve from the sample ID list, and
then you can see all the test items under that sample ID;

3) Select the item which you want to check from the test item list, and then the reaction curve of
that item will be displayed.

6.3.3 Result query

Result query interface provides variety of query method, convenient for the user to quick query. In the
query interface, the system allows the user according to the sample test date, patient name,
laboratory physician, clinician, Patient No, hospital number and other information to quick query. No
matter what status the system is in, every time you just need to input one condition to query all the
required results. The default is test date query.

(1) Date query

1) Click icon, to enter the Query interface;

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Figure 6.3.3-1 Query interface

The main function keys:

【REVIEW】: Click this button, and then the system will base on the input query condition to display
the test results.

【PRINT】: Print the selected test result.

【DEL】: Delete the selected test result.

【Backup print】: Backup print the test results in the form of PDF.

【Output】: Output the test results to computer desktop in the form of text.

2) Select the Test Date option button from Review Index.

Figure 6.3.3-2 According to test date query interface

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3) Input the test date which you want to query sample results in【Test Date】;

4) Click REVIEW button, and then the system will base on the input query condition to display the
test results.

(2) Clinician query

1) Click icon, to enter the Query interface;

2) Select the Doctor option button from Review Index.

Figure 6.3.3-3 According to clinician query interface

3) Input the clinician’s name in【Doctor】;

4) Click REVIEW button, and then the system will base on the input query condition to display the
test results.

(3) Laboratory physician query

1) Click icon, to enter the Query interface;

2) Select the Operator option button from Review Index;

Figure 6.3.3-4 According to laboratory physician query interface

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3) Input the laboratory physician’s name in【Operator】;

4) Click REVIEW button, and then the system will base on the input query condition to display the
test results.

(4) Patient name query

1) Click icon, to enter the Query interface;

2) Select the Patient Name option button from Review Index;

Figure 6.3.3-5 According to patient name query interface

3) Input the patient name in 【Patient Name】;

4) Click REVIEW button, and then the system will base on the input query condition to display the
test results.

(5)Inpatient ID query

1) Click icon, to enter the Query interface;

2) Select the Inpatient ID option button from Review Index;

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Figure 6.3.3-6 According to Patient No query interface

3) Input the Patient No in【Inpatient ID】;

4) Click REVIEW button, and then the system will base on the input query condition to display the
test results.

(6)Lab ID query

1) Click icon, to enter the Query interface;

2) Select the Lab ID option button from Review Index;

Figure 6.3.3-7 According to Hospital number query interface

3) Input the patient’s hospital number in【Lab ID】;

4) Click REVIEW button, and then the system will base on the input query condition to display the
test results.

6.3.4 Result edit/modify

After complete the tests, if it is found that a test result, just exceeding the reference or linear range,
then the system allows you to edit or correct the result. User can modify the test result through
sample registration interface.

Note

According to objective factor (patient's condition and sample’s condition) to correct the
results, please do not blind to modify. Please combine the QC test results in recent days to
calculate the coefficient. Please modify the test results under the supervision of a doctor or
laboratory management personnel, in order to prevent fault diagnosis caused by result
change is too big.

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Remind
You need through the operations in this chapter to add the manual item’s test results to the
test report.

1) In Sample registration interface, select the sample ID which you want to modify the test results
from the sample ID list;

2) Click Result processing button which in the lower left corner, and then the “Add and modify test
result interface” will pop up, as shown in figure 6.3.4;

Figure 6.3.4 Add and modify test result interface

The main function keys:

【Evaluate】: Assign the test results to the selected item.

【DEL】: Delete the selected result.

【SAVE】: Save the current setting.

【RETURN】: Return to sample registration interface.

3) Select the item which needs to add, edit or modify from the item list;

4) Input or select the wanted result in【Result】 column;

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The drop-down list includes: Positive, Negative, Weak positive, 2 +, 3 +, 4 +, etc.

5) Click Evaluate button to assign the input result to the selected item and display it in the result
list;

6.4 Database maintenance

Backup or restore various test data to avoid data loss. System provides convenient database
maintenance function for user.

Database maintenance consists of three parts: Database backup, Database restore and Automatic
backup.

6.4.1 Database backup

1) Click menu bar Data processing → Database maintenance → Database backup, to pop up the
Database backup dialog box;

Figure 6.4.1 Database backup interface

2) Click BACKUP button, to pop up the operation hints;

3) Click Confirm button to complete the database backup.

After complete the database backup, the system will pop up Whether to delete the sample
information dialog box, click the Confirm button to delete the sample information from the database,
and click Cancel button will keep the sample information in the database.

Note

URIT suggests delete all or part of the data when backup, otherwise the database is too
large and will affect system operation.

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6.4.2 Database restore

1) Click menu bar Data processing→Database maintenance→Database recovery, to pop up the


Database restore dialog box;

Figure 6.4.2 Database restore interface

2) Click Select database to recover button, to select the database which needs to restore;

3) Click RECOVER button, to pop up the operation hints dialog box, and then click Confirm button
in the dialog box;

4) If you need to back up the current database, please click Confirm button, if not, just click Cancel
button.

6.4.3 Automatic backup

1) Click menu bar Data processing → Database maintenance → Automatic backup, to pop up the
Automatic backup setting dialog box;

2) Select Automatically Backup;

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Figure 6.4.3 Automatic backup interface

3) Select Monthly to backup or Weekly to backup button;

4) Select the automatic backup date behind Specific Date;

5) After click SAVE button, please click Return button to exit this procedure.

6.5 Print test result

All kinds of test results and the data can be printed out by the default printer and specified print
template. You can set the printer type, default printer and hospital name shown on the report, and
also you can set the print order of test items.

6.5.1 Item print order setting

1) Click menu bar Biochemical test→Item Sequence, to enter interface;

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Figure 6.5.1 Item display and print order setting interface

The main function keys:

【ADD】: Add the item from item list to the end of Sequence List

【DEL】: Delete the selected item in Sequence List

【INSERT】: Select the item from item list, and then click this button to insert it to the Sequence List
before selected item

【SAVE】: Save the current setting

【RETURN】: Return to main interface

2) Click the corresponding buttons to adjust the print order of test items;

3) Click SAVE button to save the current setting.

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6.5.2 Print QC Result

6.5.2.1 Print QC Result

1) In main menu, click Biochemical test→Biochemical QC management→Daily QC data, to enter


interface;

Figure 6.5.2.1 Daily QC data interface

2) Input the test date which needs to print QC results in QC Date;

3) Click PRINT button to print;

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6.5.2.2 Print QC Result Chart

1) In main menu, click Biochemical test→Biochemical QC management→QC Date Chart, to enter


interface;

Figure 6.5.2.2 QC chart analysis interface

2) Select the item which needs to print QC chart from the【Item List】;

3) Select the analysis date of this QC item from the【DATE】;

4) Select Dynamic QC chart or Standard QC chart;

5) Select QC rules from the【QC rules】,options include LeveyJennings and Westgard;

6) Click PRINT button;

7) Select the installed printer in the pop-up window for printing.

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6.5.3 Print Sample Report

After complete the sample tests, system allows to print the test report under sample registration
interface and result query interface.

1) Click icon, to enter the sample registration interface;

2) Select the sample ID which needs to print from the sample ID list;

3) Click Print button, then the system will according to the default printer and print template to print
the test report.

Patient report default print template is as below:

Figure 6.5.3-1 Patient report default print template interface

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Other default print templates are as below:

Figure 6.5.3-2 Item parameter report default print template

Figure 6.5.3-3 Within-day QC report default print template

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Figure 6.5.3-4 Item result report default print template

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Figure 6.5.3-5 Between-days QC report default print template

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CHAPTER 7 ADVANCED SETTINGS

In the process of biochemical test, the user sometimes needs to do some special settings. This
chapter is mainly to introduce the user to set blank, substrate exhaustion judgment method, custom
print and LIS.

7.1 Blank setting

Note

Blank setting is only effective in the endpoint method.

7.1.1 Introduction

In testing, for some special reagent, user needs according to its features to do the related blank
setting. For example: in immune reagent’s emulsion method item, there is a unique blank
interference in emulsion method reagent, and it cannot be eliminated by 2-point endpoint method.
Takes H-CRP item as an example, the item uses double reagent, after the first reagent mixed with
sample, it still the same like common reagent, but after adding the second reagent, it will produce a
absorbance jump, and then gradually reaction. And this sudden jump is due to the latex
components in the second reagent, so the smooth curve which behind that is the real reaction, so
you should select the stable range to calculate the results, as shown in figure below:

Real absorbance changes

Calculation part for current


Dotted line is jump part
2-point endpoint method

Figure 7.1.1 Immune item reaction curve

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7.1.2 Blank setting

Software blank setting provides blank calculation start point (n) setting and blank calculation end
point (m) setting, to avoid the jump part, so that the calculation results more close to the real value.

Because different reagent or item may cause different jump position, so the software provides
different setting selections, as shown in figure below:

Figure 7.1.2-1 Blank setting selection

Advanced mode setting requires you according to the corresponding immune reagent item’s reaction
curve to set the blank start point and blank end point, thus avoid the blank jump part for effective
calculation.

Generally, there are four settings in advanced mode (only discuss single reagent or double reagent),
takes adding sample point and adding R2 point as nodes, as shown in figure 7.1.2-2, blank selection
range is divided into A, B and C three parts.

Single reagent item is open blank 1 and blank 2 settings.

Double reagent item is open blank 1, blank 2, blank 3 and blank 4 settings

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Figure 7.1.2-2 Blank setting selection range

Takes double reagent item as an example, the specific method is as follows:

1) The first blank setting, takes sample(S) as node, selects Before adding sample as blank
interval, as shown in figure 7.1.2-3, S is the adding sample point, the blank absorbance is the
average absorbance from n point to the m point.

Note

1) The interval of n and m should between the interval of R1 and S.

2) Point m should be greater than or equal to point n.

Figure 7.1.2-3 Before adding sample

2) The second blank setting, takes sample(S) as node, selects After adding sample as blank
interval, as shown in figure 7.1.2-4, S is the adding sample point, the blank absorbance is the
average absorbance from n point to the m point.

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Note
1) Point m should be greater than point n.

2) M times period should be less than the first reagent’s incubation time.

Figure 7.1.2-4 After adding sample

3) The third blank setting, takes adding the second reagent(R2) as the node, selects Before
adding the second reagent as blank interval, as shown in figure 7.1.2-5, R2 is the adding the
second reagent point, the blank absorbance is the average absorbance from n point to the m
point.

Note
1) Point m should be greater than point n.

2) M times period should be less than the second reagent’s incubation time.

Figure 7.1.2-5 Before adding the second reagent

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4) The fourth blank setting, takes adding the second reagent(R2) as the node, selects After
adding the second reagent as blank interval, as shown in figure 7.1.2-6, R2 is the adding the
second reagent point, the blank absorbance is the average absorbance from n point to the m
point.

Note
1) Point m should be greater than point n.

2) M times period should be less than the second reagent’s incubation time.

Figure 7.1.2-6 Before adding the second reagent

7.2 Substrate exhaustion judgment method

7.2.1 Introduction

Note
Substrate exhaustion judgment is only effect on rate method.

In rate method test, some high concentration (active) sample will make substrate exhaustion, make
the reaction is no longer level 0 or level 1, if the instrument does not have the substrate exhaustion
judgment function or set the identification parameters incorrectly, will lead to incorrect results. So in
order to correctly reflect the determination results, it is necessary to set the substrate exhaustion limit
(a specific absorbance), this absorbance is the critical point of linear area and nonlinear area or level
1 reaction area and multistage reaction area.

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When uses continuous monitoring method to test the enzyme activity, during the monitoring periods,
if absorbance increase or decrease more than the substrate exhaustion limit, then the sample
enzyme activity is very high, the substrate will be exhausted, so the absorbance will deviate from the
linear, make the determination results is unreliable.

This analyzer provides two kinds of substrate exhaustion judgment method, and figure 7.2.1 shows
the substrate exhaustion situation in single reagent and negative reaction

Figure 7.2.1 Substrate exhaustion(Single reagent, negative reaction)

7.2.2 Substrate exhaustion judgment method 1(absorbance limit)

Relevant experiments are used to determine the absorbance value of substrate exhaustion, set the
limit, the average of last three points in positive reaction absorbance reading area is greater than the
absorbance value of substrate exhaustion limit, negative reaction is less than this value, then judged
as substrate exhaustion. Figure 7.2.2-1 is the first substrate exhaustion judgment setting area.

Figure 7.2.2-1 The first substrate exhaustion judgment setting area

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Figure 7.2.2-2 Substrate exhaustion(Single reagent, forward reaction)

7.2.3 Substrate exhaustion judgment method 2(Slope ratio)

Substrate exhaustion judgment method 2: Judgment based on reaction curve slope (absorbance
change rate), and set the related settings in reagent parameter setting interface.

Figure 7.2.3-1 The second substrate exhaustion judgment setting area

Meaning for each parameters:

1) Main slope(Main points reading area)

Test points: Normal points reading area’s slope (absorbance change rate) which set up by reagent
parameters.

2) Deputy slope(Deputy points reading area)

In the second substrate exhaustion method, set the points reading area’s slope (absorbance change
rate).

3) Start point

Deputy slope as the reading point start point, in single reagent, start counting point after adding the
sample; in double reagent, start counting point after adding the second reagent, and then start point
cannot greater than the main slope’s start reading point.

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4) End point

Deputy slope reading point end point, and the reading point of end point should be less then the last
point of main slop.

5) Slope ratio

Slope ratio: Main slope/deputy slope. When the value of the slope ratio is less than the setting value,
then it will be judged as substrate exhaustion, this method can be used in conjunction with the first
method 1, or only use the first method.

When it judged as substrate exhaustion, no matter is triggered by the first method or the second
method, as long as you check the second judgment method, the system will automatically take the
deputy slope (absorbance change rate) as the calculation slope, and then the sample result is:
deputy slope ×K.

Note
Deputy slope’s start point is restricted by main slope’s start point, so the start point cannot
be greater than the main slope’s start point, and the end point is also cannot be greater
than the main slope’s end point.

A: Deputy points reading area B: Main points reading area


Figure 7.2.3-2 The second substrate exhaustion judgment method

(Single reagent, negative reaction)

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Note
Double reagent judgment method is the same as the above method.

7.3 LIS setting

7.3.1 Introduction

LIS(Laboratory Information System) is an external host, through the fixed interface connected to the
analyzer, used for download the sample application information, and receive the sample test results
from the analyzer. The LIS system support the function of test data from multiple biochemical
analyzers uploaded to the same server, to realize data share.

Before using the LIS to download the sample application information and realize data transmission,
you need to set up the LIS communication parameters and results transmission method.

Before using LIS function, please make sure the system has equipped with the LIS. If not, please
contact URIT or local distributor.

7.3.2 LIS communication parameter setting

Before using the LIS, you need to set up the LIS communication parameters, such as: server IP, port,
communication mode and other parameters.

1) Click menu bar System parameter → Lis connect setting, to enter the LIS connection setting
interface, as shown in figure 7.3.2;

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Figure 7.3.2 LIS setting

2) Set the following parameters;

3) Click SAVE button to save the current setting;

4) Click Connect to connect the analyzer and LIS host;

5) After the connection is successful, the icon will display in the upper right corner,
and at the same time in the instrument's working state bar shows that the LIS is connected.

The meaning of main parameters:

1) Host

Input the IP address of LIS host. Through the network to connect the LIS host to the analyzer and the
connection is based on TCP/IP protocol.

2) Port

Input the LIS host communications port, that is the LIS server monitoring port number.

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3) Communication Mode

Set the communication mode between the analyzer and LIS host, options include: One way and two
way.

One way transmission: The biochemistry analyzer can only send the test results, sample information
and QC information to the LIS server, but cannot get sample application information from the LIS
server.

Two way transmission: The biochemistry analyzer can not only send the test results, sample
information and QC information to the LIS server, but also can get sample application information
from the LIS server; and at the same time, the LIS server can also send the sample application
information to the analyzer’s LIS module.

4) Send Result Real-time

If the user selects this check box, after the end of each test and obtain test results, the system will
automatically send the test results to the LIS.

5) Get sample info real-time

If the user selects this check box, the analyzer will get sample application information from the LIS
server in real time. This setting is only used for two-way transmission mode.

6) Auto Connect

If the user selects this check box, when start the software system, it will automatic connect to the LIS
server.

7) Connect timeout

Set the analyzer and the LIS server connection timeout limit, the unit is in seconds.

When the analyzer is download the sample application from the LIS, or trying to connect or send
results to the LIS, if the connection time is beyond the set timeout limit, then the system will gives
alarm and prompt connection fails.

8) Same sample barcode

When the barcode of download sample is already exists, please select the required operation in the
drop-down menu. The system provides the following options:

◆ Added: Added a new sample ID for the same sample barcode;

◆ Skip: Do not handle the existing same sample barcode’s sample information;

◆ Cover: Use the current sample to cover the existing sample (including the sample information,
test results, etc.).

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7.3.3 Send test result to LIS

After the connection is successful, the icon will display in the upper right corner, and
then double click this icon to enter the LIS task management interface, as shown in figure 7.3.3:

Figure 7.3.3 Send test result to LIS

The main function keys:

【Upload】: Upload the analyzer’s sample information to the LIS host.

【Download】: Download the sample information from the LIS server.

【 Illegal Item 】 : This biochemical item does not exist in the current biochemical management
system.

【Download History】: The analyzer downloads the related sample information from the LIS server,
including: operation time, query barcode, query start time, query end time and query status.

【Settings】: Set the basic parameters of the Lis.

【Return】: Return to the biochemical management interface.

【Send】: Send the selected sample information to the LIS server.

: Select the test date which you need to send the sample information from this
drop-down menu.

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: This drop-down menu has three options, including: All, Sent and not Unsent.

 All: Display all the sample information under that test date in the sample information list,
including the sent one and unsent one.

 Sent: The sample information list only displays the sample information which has already sent to
the LIS server.

 Unsent: The sample information list only displays the sample information which not sent to the
LIS server, and marked in green.

【Marked as sent】: Set the selected sample information (which has not sent to the LIS server) to
send state, and marked in green.

【 Marked as unsent 】 : Set the selected sample information (which has already sent to the LIS
server) to unsent state.

【Refresh】: Refresh the current interface.

Please follow the steps below to send the sample information of the analyzer to the LIS server:

1) Click icon;

2) Select or input the test date which you need to send the sample information in the dateline;

3) Click Send button, and then the system will automatic send the results to LIS server, and
marked in green.

Note
If the sending process is disconnected, please reconnect to the LIS server, and then select
the unsent data continue to send.

7.3.4 Download the sample application information

Double click icon to enter the LIS function module, and the click icon to
switch to download interface, as shown in figure 7.3.4:

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Figure 7.3.4 Download the sample application information

The main function keys:

【Download】: Download the required sample application information from the LIS server.

【Add】: Add the download sample information to the routine test list.

【Delete】: Delete the selected sample information.

【Save】: Save the current sample information.

Please follow the steps below to download the sample application information from the LIS server:

1) Select the sample information query method, and then enter the corresponding query conditions:

Download interface provides two kinds of sample information query methods:

◆ According to barcode query

After check the According to barcode query, and then input the specified sample barcode in
【Barcode】column. Then the system will download the required sample information.

◆ According to time query

After check the According to time query, and then input the specified sample application date in
【Time】column. Then the system will download the required sample information.

2) Click Download button ,then the system will download the required sample information and
display in the sample information list;

3) After complete the download, please set up the sample positions for the selected sample
information and loaded them into the test list, operation steps are as follows:

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a) Select the test type from the【Test type】pull-down menu;

Options include: routine and emergency.

b) Input the sample ID in【Sample ID】;It is recommended to use the system default sample
ID.

c) Select the sample placing position from 【Sample cup】pull-down list; It is recommended to use
the system default sample cup number.

d) Select the size of cuvette from【Size of Cup】pull-down list;

e) Select the virtual sample tray from【Dummy tray】pull-down list;

f) Options include:D1~D20

g) Click Add button to add the download sample information to the routine test list.

4) After complete the above operations, please return to the routine test interface, and then click
Test button, to actually add the sample application information to test.

Note
There may be individual items does not exist in the biochemical analyzer system from the
download sample application information, their called illegal items, such items will not be
tested, for the specific information, please check the "Illegal item” interface.

7.4 Custom print setting

7.4.1 Introduction

All kinds of test results and the data can be printed out by the default printer and specified print
template. You can set the printer type, default printer and hospital name shown on the report, and
also you can set the print order of test items.

System provides custom print setting, allows the user to adjust the report print template. Before set
custom print setting, please make sure that the current biochemical analyzer system has this
function.

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7.4.2 Template management

In menu bar, click System parameter→Print setting to enter the print setting interface. Print setting
interface is divided into two sub-interfaces, one is template edit interface, the other is print ID
dictionary setting, and the template edit interface is the default interface, as shown in figure 7.4.2-1.

Figure 7.4.2-1 Template management

The templates in current system are mainly include patient report, item parameter report, within-day
QC report, between-days QC report and item result report, each category has different conventional
print template and purpose.

 Patient report: Used for print the patient sample test results, and this report category is using
most frequently.

 Item parameter report: Used for print the test item related parameters, convenient for user to
understand this item’s parameter setting.

 Within-day QC report: Used for print the within-day quality control chart.

 Between-days QC report: Used for print the between-days quality control chart.

 Item result report: According to item to print the test results.

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Main keys:

【 Select 】 : Click this button, the system will set the selected template to default template, and
marked in Y.

【Preview Template】: Click this button to preview the selected template.

【Edit】: Click this button to edit the selected template.

Users can edit the template by the following steps:

1) Select the report type from the left side of the template management interface;

2) Select the template which needs to edit from the conventional print template list;

3) Click Edit button to enter the template editing interface;

Figure 7.4.2-2 Edit test template interface

4) According to the needs to edit and adjust the template;

5) Click File→Save, to save the edited template.

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7.4.3 Print ID dictionary setting

Print template’s each item corresponding to a print ID, system program through the print ID to identify
the print content. Print ID dictionary setting interface is mainly used for set the tag name for the
corresponding print ID.

In print setting interface, click the Print ID dictionary setting option, to enter the interface, as shown in
figure 7.4.3.

Figure 7.4.3 Print ID dictionary setting interface

Users can set the print ID display tag name by the following steps:

1) Select report type from the report type list;

2) Select the tag name which needs to edit from the print ID list;

3) Modify the tag name in the right side box;

4) Click Save button to save the current setting.

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CHAPTER 8 QUALITY CONTROL ANALYSES AND CALIBRATION

8.1 General information

The reliability of test result is determined by two aspects: One is the precision, which means test
results are stable in repeatability. Precision can be guaranteed by establishing perfect room quality
control system; the other one is accuracy, which means test results close to target value. Accuracy
can be guaranteed by proper method and calibration. It is, therefore, necessary to select certified
control sample and calibration solution, and use them strictly according to their instructions.

8.2 Quality control

8.2.1 Type of quality control materials

1) Freeze-dry control, liquid control and mixed control serum, classified according to physical
property.

2) Fixed value and non-fixed value control sample, classified according to the presence and
absence of fixed value. Different inspection body can choose more than one quality control as
quality control.

Inspection institutions should be according to their own situation to choose one or more than one
quality control materials as their indoor quality control materials.

8.2.2 Use and storage

1) Use control sample following the Instructions for Use provided by control supplier.

2) Make sure the quality of control solution redissolved from freeze-dry control sample is stable.

3) Make sure the dilution ratio is accurate and consistent each time redissovling freeze-dry control
sample.

4) DO NOT shake control sample fiercely when redissovling freeze-dry control sample.

5) Store control sample according to requirement. DO NOT use expired product.

6) Perform QC analyses under the same operating conditions as that of sample analyses.

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8.2.3 Setup of target value, SD and control Limit

QC target value and control limit are usually provided by the control samples supplier, also, you can
determine them through the following methods:

1) Setup of interim target value (mean value) and SD

Perform QC analyses at least 20 times with a new batch of control sample. Calculate the mean
value and standard deviation from the obtained QC data.

2) Setup of regular target value (mean value) and SD

Obtain the accumulated mean value of original 20 QC data as the target value while the
accumulated mean value of 3~5 month QC data as the standard deviation.

3) Setup of control limit

Control limit is the multiplier of standard deviation. Control limit of analytical item is determined
according to different QC rules.

8.3 Calibration

Calibration solution contains the known quantity object, which is used for calibrating the value of this
method; the calibration solution is concerned with the method, reagent and instrument. The function
of calibration solution is to reduce or eliminate systematic error caused by instrument and reagent. It
should be better to use human serum matrix to reduce matrix effect.

It is suggested to perform calibration every six months or under the following situations:

 When initially installing and running the instrument.

 When changing reagent batch number or type, unless specified by the lab that the change will
not influence the precision.

 After replacing the major components, such as lamp, sampling mechanism, probe, or cuvette
etc.

 After performing a preventive maintenance on the instrument.

 When control result shows abnormal offset, tendency, or falls out of the acceptable range and it
cannot be corrected by routine tests.

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8.4 Reasons of random error

Below are the possible reasons of random error.

1) Inaccurate dispensing volume (sample, reagent)

Aspirating mechanism is leakage; air bubbles in flow path; contaminated probe; deflective
injection of reagent, etc.

2) Optical system failure

Lamp is faulty.

3) Metamorphic Reagent

Metamorphic Reagent

4) Adverse quality-control samples

Use of wrong control sample;

5) Inadequate wash

Stirrer wash is inadequate.

6) Adverse mixture

The depth of stirrer to cuvette is excursion; stirrer mechanism faulty.

8.5 Reason of systematic error

1) Inaccurate standard

The dissolvent of standard solution is inappropriate

2) Metamorphic reagent

The reagent is metamorphic, and the batch number is various.

3) Temperature

The temperature control is inappropriate

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8.6 How to deal with out-of-control

According to the following procedures to deal with the Out-of-Control situations:

1) Fill in Out-of-Control report and report to your lab supervisor.

2) Simply and quickly review the operating procedure to find out the possible reasons.

3) If no evident error is found, move to the following steps for further checkup.

 Retest the out-of-control item by using the same bottle of control sample. Strictly obey the
operation flow to check if the out-of-control is due to operation incorrectly or random error. If
retest result falls outside the acceptable range, proceed to the next step.

 Retest the out-of-control item by using a new bottle of control sample (same lot). If retest result is
in control, the previous bottle of control sample may be to blame. If retest result still falls outside
the allowable range, proceed to the next step.

 Retest the out-of-control item by using a new lot of control sample. If retest result is in control,
the previous lot of control sample may be deteriorated. Then check the expiration date and
storage condition. If retest result still falls outside the allowable range, proceed to the next step.

 Perform instrument maintenance; retest the out-of-control item. Check the instrument state;
check whether the light source is changed or not; and whether the cuvette need to wash or
replaced. Furthermore, replacing reagent. If the retest result still falls outside range, proceed to
the next step.

 Re-calibration and retest out-of-control item. Perform calibration by using new calibrating
solution. Proceed to the next step if the result still falls outside range.

 Obtain technical help. If you cannot get the in-control result after performing the above five steps,
contact reagent manufacturer or URIT to get more technical support.

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CHAPTER 9 CARE AND MAINTENANCE

Routine care and regular maintenance are essential to keep the best status, precision of the analyzer
and minimize system problems, prolong the life span, please strictly follow this manual to do the
system operation and regular maintenance. Even if you are just an operator, knowing the care and
maintenance knowledge in this chapter is also very important, in-depth study will help you use the
instrument in best running status and performance.

The system provides the instrument maintenance instructions, through the maintenance instructions
to perform basic maintenance operations. Please record the time and content for each maintenance
for later viewing.

For the problems which cannot be solved or covered in this chapter, please contact URIT.

Warning

1) Please strictly follow this manual to operate, otherwise may cause the instrument
damage or personal injury.

2) Please perform the instrument maintenance after trained and authorized by URIT,
otherwise the commitment terms which in the contract are no longer valid.

3) Do not spray the liquid such as water, reagent and detergent on the system’s
mechanical or electrical parts.

4) For safety reason, please turn off the test power supply and main power supply before
maintenance.

Biological Hazard

During the maintenance, be sure to put on protective gloves, clothes, or even goggles if
necessary when dispose waste solution.

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9.1 Maintenance equipment and tools

In maintenance, you may use the following tools and strengthen detergent.

 Tools

1) A set of internal hexagonal wrench

2) Straight screwdriver(middle size)

3) Needle detector

4) Clean beaker

5) tweezers

6) Clean gauze

7) Clean cotton swab

8) Brush (used when cleaning bucket)

 Detergent

1) Alkaline detergent (concentrated detergent)

2) Acid detergent

3) Sodium hypochlorite solution which concentration is 10%~30%.

Note

1) When using concentrated detergent, please dilute detergent properly first.

2) Do not mix the acid detergent with alkaline detergent, when they mixed, it will produce
poisonous gas.

3) Please use the detergent specified by URIT, otherwise may not be able to obtain accurate
analysis results.

 Others

1) Anhydrous alcohol

2) Clean beaker

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9.2 Instrument maintenance instructions

The system provides the instrument maintenance instructions, through the maintenance instructions
to perform basic maintenance operations, including: rinse sample probe and stirrer, clean the
reaction cup, reaction cup signal reading, A/D signal reading, instrument status query, temperature
check and barcode.

9.2.1 Probe and Stirrer Cleaning

Clean the sample adding probe and stirring stick to avoid the reaction solution remains in the flow
path, specific operations are as follows:

1) In main menu, click “Instrument maintenance→Probe and Stirrer cleaning”, or directly click the

icon, to enter the interface;

Figure 9.2.1 Probe and Stirrer cleaning interface

2) Input the number of you want to clean in the Wash times, the default is 1 time, maximum up to
five times;

3) Click WASH button, and then the system start to clean the sample adding probe and stirrer.

The main function keys:

【WASH】: Clean the sample adding probe and stirrer.

【RESET】: Perform the reset operation.

【RETURN】: Return to the maintenance interface.

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Note

1) In order to keep the sample adding probe and stirrer clean, please at least perform
five times rinse operation a day when starting up.

2) Before perform rinse operation, please make sure the No.62 position of sample tray
and the No.80 position of reagent tray have enough detergent.

9.2.2 Cuvette cleaning

Clean the reaction cup to avoid the reaction solution remains in the reaction cup, specific operations
are as follows:

1) In main menu, click Instrument maintenance → Cuvette Rinsing, or directly click the

icon, to enter the interface;

Figure 9.2.2 Cuvette cleaning interface

2) If you want to clean all the reaction cups, please select from 1 to 90 and then click the WASH
button; or click the WASH button which behind the All Cuvettes. If you want to selective clean
the reaction cups, please input the reaction cup number which you want to clean, and then click
the WASH button.

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The main function keys:

【Add Water】: All the reaction cups filled with distilled water.

【DeepClean】: Clean all the reaction cups with detergent.

【STOP】: Stop the current cleaning action.

Note
1) In order to keep the reaction cup clean, please at least perform 1 time rinse operation
for all the reaction cups a day when power on and power off.

2) In order to keep the reaction cup clean, please at least perform 1 time strengthen
cleaning operation a week.

9.2.3 Cuvette signal reading (Cuvette blank)

Reaction cup after long time use, the inner surface will remain with substances such as protein or
debris which cannot be cleaned, it will affect the light transmittance of reaction cup; or if there are
scratches or cracks in the reaction cup inner wall or outer wall, and it also can affect the
transmittance or uniformity of reaction cup, so as to affect the accuracy and stability of the
absorbance test results. So you need to check the reaction cup’s working condition. You can check
all the reaction cup state and wavelength signal value through “Cuvette signal reading”. Specific
operations are as follows:

1) In main menu, click Instrument maintenance→Cuvette Signal, to enter Cuvette signal reading
interface, as shown in figure 9.2.3;

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Figure 9.2.3 Cuvette signal reading interface

2) Click Add Water button, to inject the water into the reaction cup;

3) After water injection is completed, please click Cuv. Blank Reading button;

4) Check the AD value in the list;

Through the left or right arrow to scroll the list, to check all the reaction cup AD value. All the listed AD
value should be within the range of 30000~65535 (instrument has been used for a period of time), if
not beyond this range any more, please contact URIT;

5) Click SAVE button, to save the read AD value;

6) Click Drain Water button to empty the reaction cup, then the reaction cup signal is read.

: Through check this button to switch the absorbance and the A/D signal

: Page turning, each page displays the absorbance of 15 reaction cups.

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9.2.4 A/D signal reading

A/D signal reading is used for determine whether the reaction cup with besmirch, whether the
attenuation of light source is below the threshold value, the reaction cup clean degree and the
radiation intensity of the illuminant light are directly affect the absorbance stability of the instrument.
Specific operations are as follows:

1) In software operation main interface, click icon, to enter “AD signal reading
interface, as shown in figure 9.2.4:

Figure 9.2.4 A/D signal reading interface

2) The instrument will automatically read the AD value.

The main function keys:

【TO LIGHT】: Rotate the reaction tray to optic center and reads the initial position.

【ZERO】: Absorbance returns to zero.

【RESET】: Re-clock.

【SET】: Change the Numbers on the left, and then click SET to adjust the AD value.

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9.2.5 Instrument status query

Instrument status query is mainly to check the instrument status is normal or not. Specific operations
are as follows:

1) In main menu, click Instrument maintenance→Instrument status query, to enter interface, as


shown in figure 9.2.5;

Figure 9.2.5 Instrument status query interface

2) Click Detection button to start the test;

The main function keys:

【Detection】: Click Detection button to start the test;

【Clear Error】: If the instrument has malfunctioned (such as firing pin, command receiving anomaly,
communication failure, etc.), the instrument will record the error status, and through the error flag to
prohibit instrument continues to execute the command. When the error flag is cleared, the instrument
can continue to execute the command.

Note
When there is a problem, please check the instrument status to find the reason.

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9.2.6 Temperature check

Please through the temperature check interface to check the temperature of reagent tray and
reaction tray. If the temperature is beyond the normal range, it will be displayed in red.

In main menu, click Instrument maintenance → Temperature check, or directly click


icon, to enter the Temperature check interface, as shown in figure 9.2.6:

Figure 9.2.6 Temperature check interface

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9.2.7 Barcode scanning

In main menu, click Instrument maintenance → Barcode, to enter Barcode scanning interface, as
shown in figure 9.2.7-1;In this interface, you can scan the sample and reagent barcode. The default
is sample barcode scanning interface.

Figure 9.2.7-1 Sample barcode scanning interface

1) Scan sample barcode

If only scans one sample barcode, please select the sample position which needs to scan from the
drop-down list box behind Single, selective position from 1 to 79, and then click Single button;

If you want to scan all the sample barcode, please directly click “Scan All” button.

2) Scan the reagent inner ring barcode

Select the Scan Inner in barcode scanning interface to enter the scan the reagent inner ring barcode
interface.

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Figure 9.2.7-2 Scan the reagent inner ring barcode interface

If only scans one reagent inner ring barcode, please select the reagent position which needs to scan
from the drop-down list box behind Single, selective position from 1 to 40, and then click single
button;

If you want to scan all the reagent inner ring barcode, please directly click Scan All button.

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3) Scan the reagent outer ring barcode

Select the Scan Outer in barcode scanning interface to enter the scan the reagent outer ring
barcode interface.

Figure 9.2.7-3 Scan the reagent outer ring barcode interface

If only scans one reagent outer ring barcode, please select the reagent position which needs to scan
from the drop-down list box behind Single, selective position from 41 to 80, and then click Single
button;

If you want to scan all the reagent outer ring barcode, please directly click Scan All button.

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9.3 Daily maintenance

Daily maintenance shall be performed at the end of a day or before you start test, mainly for check
the distilled water bucket, waste solution bucket, detergent bottle, syringe, sample probe, reagent
probe, stirrer and printer.

9.3.1 Check the distilled water bucket

Lack of distilled water or distilled water bucket connection abnormal, can lead to water supply
shortage or leaking, and result in the test cannot be continuous.

1) To check the remaining volume of distilled water. If it is lack of , please turn off power and add
enough distilled water.

Cover of the mouth to add


distilled water

Figure 9.3.1-1 Cover of distilled water barrel

2) To check whether the pipeline insert well or not. If leakage, do the following steps:

a. Take out pipe and check whether the pipe is damage or not.

Figure 9.3.1-2 take out distilled water pipe

b. If the pipe is damage, cut off the damage part; if not, tighten the pipe and confirm whether there
leakage or not again.

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9.3.2 Check the Detergent Bucket

Note

Please use the detergent manufactured by URIT.

Detergent insufficient will result in the test cannot be continuous. Please check the detergent
remaining volume every day before start testing, if the detergent is insufficient, you should be added
in time.

Cover of the mouth


to add detergent

Figure 9.3.2-1 cover of detergent bucket

1) Confirm the test power supply has been turned off.

2) Add the detergent to the bucket which has been make up well.

3) Screw on the cover of detergent bucket.

To check whether the connector is leakage or not. If so, do the following steps:

1) Turn off power and screw off connector.

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2) Take out pipe from the blue connector and cut off the damage part.

3) If there are no damage, tighten the pipe and confirm whether there are leakage or not again.

9.3.3 Check the waste solution bucket

Waste solution bucket connection abnormal, or not timely empty the waste solution bucket, it will
cause waste solution overflow, so as to cause environmental pollution and cross contamination, even
damage the instrument. Therefore, regularly check the waste solution bucket and its connection are
very necessary.

Biological Hazard
1) Be sure to put on protective gloves, clothes, or even goggles if necessary when
dispose waste solution.

2) Waste solution must be disposed according to the relevant environmental protection


regulations, please consult the relevant reagent manufacturer or distributor.

1) Confirm the test power supply has been turned off;

2) Take out BNC cover and components.

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Fat tube
BNC cover

Figure 9.3.3-1 Waste solution bucket diagram

Figure 9.3.3-2 screw off BNC cover 9.3.3-3 take out BNC components

Figure 9.3.3-4 take out fat tube

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3) Empty the waste solution bucket into the hospital specified waste solution processing pool;

4) Connect the waste solution tubes;

9.3.4 Check the Detergent and Diluent solution in Sample Tray, Reagent Tray

Detergent or diluent insufficient will result in the test cannot be continuous. Please check the
detergent and diluent remaining volume every day before start testing, if the detergent or diluent is
insufficient, should be added in time.

1) Check the detergent in sample tray’s No.62 sample adding probe cleaning position, if not
enough, should be added.

2) Check the detergent in reagent tray’s No.80 reagent probe cleaning position, if not enough,
should be added.

3) Check the diluent in NO.78 position of reagent tray, if not enough, should be added.

9.3.5 Check/Clean the Sample Adding Probe, Stirrer

If sample probe, reagent probe or stirrer is abnormal, then the instrument will not be able to correct
analysis. So before test, check the outer wall of sample adding probe and stirrer for any stains and
crystallization, and check whether the sample adding probe and stirrer are clogged or bend.

(1) normal state (2) abnormal state (3) abnormal state

Figure 9.3.5 Reagent probe/sample probe’s normal and abnormal flow direction

If there are any stains and crystallization, please refer to 9.6.2 and 9.6.3 to clean.

If the sample adding probe and stirrer are clogged or bend, please contact URIT for replacement.

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9.3.6 Check the Printer/Printing Paper

Please check whether the printer is work properly, and the printing paper is enough or not.

9.4 Weekly Maintenance

In order to keep the instrument best working state and safe to use, please weekly perform the
following maintenance.

9.4.1 Clean the Sample Add Probe

Caution
1) Please operate with cautious, in order to avoid your hand scratched by sample
adding probe.

2) Ethyl alcohol has flammability, when using, need to be very careful.

Biological Hazard
1) Be sure to put on protective gloves, clothes, or even goggles if necessary when
operating.

2) The used gauze must be disposed according to the relevant environmental


protection regulations.

The inner side of sample adding probe and the outward of needle tip are easy to contaminate, not
only easy to adhere serum, reagent, water, etc., but also easy to cause the clogging, so it need to
regularly checking and properly cleaning.

1) Turn off the test power supply;

2) Gently upward pull the sample adding probe rocker arm to the highest point, and then through
rotate the rocker arm to move the sample adding probe to the easy operation position;

3) Use the tweezers to pick up the gauze which dip in the anhydrous alcohol, and then wipe the
surface of probe from top to bottom, until the probe surface is clean and no sticky dirty.

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Figure 9.4.1-1 clean sample probe 9.4.1-2 clean stirrer

Caution

1) When cleaning, do not use the tweezers to direct contact with the sample adding
probe, prevent it scratches the sample adding probe; please avoid overexertion to
prevent reagent probe deformation.

2) After you complete the sample adding probe surface cleaning operation, please rotate
it to the top of rinse tank.

4) Turn on the instrument test power source;

5) In menu bar, click Maintenance→Instrument parameter setting ,and then input the password,
to enter the interface, and then click Reset button, and then the system will automatic reset the
sample adding probe and rinse it with distilled water;

6) Click Maintenance → Sample adding probe and stirrer cleaning, and then the system will
automatic rinse the sample adding probe and stirrer with distilled water (Recommend 3 to 5
times).

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Figure 9.4.1-3 Probe and stirrer clean

9.4.2 Clean washing pool

After long-time use, the waste or dirt are easy to silting-up in washing pool, so that to block pipe. It is
suggests to clean the pool per week.

Caution
Please operate with cautious, in order to avoid your hand scratched by sample adding
probe.

Biological Hazard
1) Be sure to put on protective gloves, clothes, or even goggles if necessary when
operating.

2) The used gauze must be disposed according to the relevant environmental


protection regulations.

1) Turn off test switch.

2) Pull the arm of probe and stirrer to the top point and turn round to a position where easy to
operate.

3) Add 50mL chloros solution or alcohol (the concentration is 10% to 30%) to the pool to soak for 5
minutes.

Caution
Please clean the pool after soaking for 5 minutes. No chloros and alcohol remain
in the pipe.

4) Add 100ml distilled water to clean the pool.

5) Use a gauze which dip with absolute alcohol to wipe the surface and around part until clean.

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Note
Pay attention not to leave the gauze or other impurities in the pool to avoid block
pipe.

Figure 9.4.2-1 clean washing pool

6) Turn on test switch.

7) Start software and click probe wash icon.

8) Input 3 times and click wash icon.

Figure 9.4.2-2 probe and stirrer wash

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9.4.3 clean washing station

Caution
1) Please operate with cautious, in order to avoid your hand scratched by sample
probe.

2) When clean the washing hand, the tweezers must not touch the washing station
and do not clean too much force to avoid scratch and bend probe.

3) The gauze for wipe washing station should not dip too much distilled water to avoid
the water flow into cuvette so that pollute the cuvette.

Biological Hazard
1) Be sure to put on protective gloves, clothes, or even goggles if necessary when
operating.

2) The used gauze must be disposed according to the relevant environmental


protection regulations.

It is suggests to clean the washing station per week.

1) Turn off test switch.

2) Use a tweezers to take a gauze which dip with distilled water to clean the washing station from
up to down until the surface is clean.

Figure 9.4.3 washing station

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9.4.4 Clean the Reagent Tray/Sample Tray

Biological Hazard
1) Be sure to put on protective gloves, clothes, or even goggles if necessary when
operating.

2) The used gauze must be disposed according to the relevant environmental protection
regulations.

1) Turn off the test power supply;

2) Open the cover of reagent and sample tray.

3) Use a gauze which dip with absolute alcohol to wipe the surface of reagent and sample tray until
it is clean.

Figure 9.4.4 wipe reagent and sample tray

4) Use a gauze which dip with distilled water to wipe out the mark of absolute alcohol.

5) Put on the cover well at last.

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9.4.5 Clean the Reaction Tray

Warning

Do not use alcohol or detergent to clean the reaction tray, otherwise it will lead to reaction
cup corrosion, thus cause losses shall be borne by the user.

Caution

During the cleaning operation, the distilled water should not flow into the reaction cup;
otherwise it will contaminate the reaction cup.

Biological Hazard

1) Be sure to put on protective gloves, clothes, or even goggles if necessary when


operating.

2) The used gauze must be disposed according to the relevant environmental protection
regulations.

1) Turn off the test power supply;

2) Use the tweezers to pick up the gauze which dip in the distilled water, and then wipe the surface
and surrounding of the reaction tray, until the surface is clean and no sticky dirty.

Figure 9.4.5 clean reaction tray

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9.4.6 Clean the panel of instrument

Biological Hazard

1) Be sure to put on protective gloves, clothes, or even goggles if necessary when


operating.

2) The used gauze must be disposed according to the relevant environmental protection
regulations.

Caution

During the cleaning operation, the distilled water should not flow into the panel gap.

1) Turn off the test power supply;

2) Use the gauze which dips in the distilled water to wipe the instrument panel and the cover of the
reaction tray, the sample tray and the reagent tray, until the surface are clean and no sticky dirty.

Figure 9.4.6 clean panel

9.4.7 Deep clear the Cuvette

In order to clean the reaction cup deposition stains, and prolong the service life of reaction cup, so
you need to weekly perform the reaction cup strengthen cleaning.

1) Make sure the detergent bucket has enough detergent;

2) Click cuvette rinsing to enter the interface.

3) Click Deep clear button to start the strengthen cleaning.

4) Click all cuvette to begin clean after the cuvette soak for 5 minutes.

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Figure 9.4.7 cuvette clean

9.4.8 check the A/D value of cuvette

Reaction cup after long time use, the inner surface will remain with substances such as protein or
debris which cannot be cleaned, it will affect the light transmittance of reaction cup; or if there are
scratches or cracks in the reaction cup inner wall or outer wall, and it also can affect the
transmittance or uniformity of reaction cup, so as to affect the accuracy and stability of the
absorbance test results. So you need to check the reaction cup’s working condition.

1) Turn on the instrument test power supply, and then enter the system software;

2) In main menu, click Maintenance→Cuvette Signal, to enter interface;

3) Click Add Water button, to inject the water into the reaction cup, and then after water injection is
completed, please click Cuv. Blank Reading button

4) After complete the read cup blank operation, please check the AD value in the list:

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Figure 9.4.8 Cuvette signal reading interface

5) Through the left or right arrow to scroll the list, to check all the reaction cup AD value. All the
listed AD value should be within the range of 30000 to 60000 (instrument has been used for a
period of time).

If the AD value not in this range, please contact refer to chapter 9.6.1 to check or change the
cuvette;

If the AD value in this range, click save to save the blank value and click return.

6) Click Drain Water button to empty the reaction cup.

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9.5 Monthly Maintenance

In order to keep the instrument best working state and safe to use, please monthly perform the
following maintenance.

9.5.1 Clean the Distilled Water Bucket

1) Turn off the instrument test power supply;

2) Pull out the distilled water tube;

Figure 9.5.1-1 distillation bucket

3) Empty the remaining distilled water and take out BNC components.

Figure 9.5.1-2 BNC components

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4) Use distilled water to clean the inner wall of the bucket, if necessary, use a clean brush to clean
it;

Note

If you a clean brushes to clean the inner wall of the bucket, be careful not to scratch the
liquid level sensor, drainage pipe and the filter.

5) Use a clean gauze to wipe the distilled water bucket outside part and the lid of the distilled water
bucket;

6) Insert the distilled water tube;

7) Connect the BNC signal wire;

8) Clockwise screw on the lid of the distilled water bucket.

9.5.2 Clean the Detergent Bucket

1) Confirm the test power supply has been turned off;

2) Counterclockwise to unscrew the detergent cover;

Detergent cover

BNC Cover

Figure 9.5.2 cleaning fluid barrels

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3) Counterclockwise to unscrew the lid, and then disconnect the BNC wire and flow line;

4) Empty the remaining detergent;

5) Use distilled water to clean the inner wall of the bucket, if necessary, use a clean brush to clean
it;

Note

If you a clean brushes to clean the inner wall of the bucket, be careful not to scratch the
liquid level sensor, drainage pipe and the filter.

6) Use a clean gauze to wipe the detergent bucket outside part and the lid of the detergent bucket;

7) Cover the lip, connect the BNC and flow line, and then clockwise tighten the BNC cover

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9.5.3 Clean the Waste Solution Bucket

Biological Hazard

1) Be sure to put on protective gloves, clothes, or even goggles if necessary when


operating.

2) Waste solution must be disposed according to the relevant environmental protection


regulations, please consult with the related reagent manufacturer or distributor.

3) The used gauze must be disposed according to the relevant environmental protection
regulations.

1) Turn off the instrument test power supply;

2) Counterclockwise to unscrew the BNC cover, and remove the BNC and waste solution
tube(small size) component;

3) Pull out the waste solution tube(big size);

Fat waste solution pipe


BNC cover

Figure 9.5.3-1 waste solution bucket

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Figure 9.5.3-2 take out BNC components

4) Empty the remaining waste solution and disposed according to the relevant environmental
protection regulations;

5) Use distilled water to clean the inner wall of the bucket, if necessary, use a clean brush to clean
it;

Note

If you a clean brushes to clean the inner wall of the bucket, be careful not to scratch the
liquid level sensor, drainage pipe and the filter.

6) Use a clean gauze to wipe the waste solution bucket outside part and the lid of the waste
solution bucket;

7) Insert the waste solution tube;

8) Connect the BNC signal wire;

9) Clockwise screw on the lid of the waste solution bucket.

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9.5.4 Clean the Sample adding probe actuating shaft

Please regularly clean the sample adding probe actuating shaft to reduce the actuating shaft moving
noise and wear, to ensure the service life.

1) Turn off the instrument test power supply;

2) Gently upward pull the sample adding probe arm (sample adding probe includes sample probe
and reagent probe) to the highest point;

3) Use clean gauze to wipe the sample adding probe actuating shaft.

Figure 9.5.4 clean the shaft

Note

Do not use alcohol or other corrosive detergent to clean the drive shaft, otherwise may
cause the drive shaft carton phenomenon. Please use the special lubricants to maintain the
drive shaft.

9.5.5 Clean the Stirrer Actuating Shaft

Please regularly clean the stirrer actuating shaft to reduce the actuating shaft moving noise and wear,
to ensure the service life.

1) Turn off the instrument test power supply;

2) Gently upward pull the stirrer arm to the highest point;

3) Use clean gauze to wipe the stirrer actuating shaft.

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Figure 9.5.5 clean the shaft of stirrer

Note

Do not use alcohol or other corrosive detergent to clean the drive shaft, otherwise may
cause the drive shaft carton phenomenon. Please use the special lubricants to maintain the
drive shaft.

9.5.6 Clean the cleaning mechanism

1) Click Maintenance→Cuvette cleaning;

2) Check the cuvette cleaning process, make sure the needle tip of group 1 cleaning probe to
group 6 cleaning probe are parallel and level, the needle tip of group 7 cleaning probe and the
lower end surface of group 8 ( block) are parallel and level;

3) Check the cleaning syringe needle and block for any stain, crack, etc., please clean or replace it
if necessary.

Note

Do not use alcohol to clean the cleaning probe, because the reaction cup can be
damaged by the alcohol, please use the detergent supplied by URIT.

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9.6 Non-Scheduled Maintenance

This section introduces some long-term use and delicate parts replacement method.

9.6.1 Replace the cuvette

When the cuvette is contaminated by serum or debris, or appears scratches or broken, it will affect
the accuracy of test absorbance. So it is necessary to test the reaction cup, if found it abnormal,
should be timely replaced. Replace the reaction cup only takes about half a minute.

Warning
1) When install the reaction cup, be careful not to scratch it. Do not touch middle-lower
part of the reaction cup’s light through surface, otherwise it will cause the absorbance
data is not accurate.

2) When operating, be sure to use no fiber and powder gloves, in order to make sure not
contaminate the light through surface of reaction cup.

Biological Hazard
Be sure to put on protective gloves, clothes, or even goggles if necessary when
operating.

Caution

Please use the accessories recommended by URIT, otherwise can lead to system
performance degradation.

NOTE
1) If you really hard to remove the reaction cup from the reaction tray, you can use a
tweezers to remove the reaction cup’s shrapnel, and then remove the reaction cup by
your hands.

2) If there is a large number of reaction cups need to maintain, please contact your local
distributor or URIT.

1) Click cuvette signal reading in maintenance, click execute to enter the interface.

2) Click add and then click read cuvette blank to read.

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Figure 9.6.1-1 cuvette signal reading

3) Check whether the A/D value of all cuvette in the range of 30000 to 60000.

4) If the A/D value in the range, click save and then click return.\

5) Click washing cuvette in maintenance interface, click drain water.

6) If there are some A/D value not in the range, click read cuvette blank and confirm the following
points:

a. If the values of one of the column less than or near to 30000, it is needs to replace all cuvette or
lamp bulb.

b. If the values of one of the line less than 30000, to confirm the cup NO. and take out the cuvtte to
check. If the cuvette is good, there are bulb in the cuvette when read the cuvette blank. So it is
needs to add water again and read blank again; if there are dirt in cuvette, clean the cuvette by
distilled water, or soak for minutes firstly, then washing by distilled water after.

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Figure 9.6.1 take out cuvette

7) If the valve still out of range or the cuvette is broken, please contact distributor or URIT.

9.6.2 Unclog the Sample Probe

Warning
Please operate with cautious, in order to avoid your hand scratched by sample adding
probe.

Biological Hazard
Be sure to put on protective gloves, clothes, or even goggles if necessary when
operating.

9.6.3 Unclog the Reagent Probe

Warning
Please operate with cautious, in order to avoid your hand scratched by sample adding
probe.

Biological Hazard
Be sure to put on protective gloves, clothes, or even goggles if necessary when
operating.

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The reagent probe is not easy to block. If block, do the following steps:

1) Confirm the instrument test power supply has been turned off;

2) Observe reagent probe in rinsing compartment’s position, and remember it;

3) Gently upward pull the reagent probe arm to the highest point, and then through rotate the
rocker arm to move the reagent probe to the easy operation position;

4) Remove the arm cover;

Figure 9.6.3-1 Remove the reagent needle cap


5) Disconnect the flow path tube;

Figure 9.6.3-2 Remove the reagent 2 pin connector


6) Remove the reagent probe fixed legs, and then gently lift up the reagent probe, and then remove
the reagent probe from the position hole, from bottom to top.

Caution

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When remove the reagent probe fixed legs, please don't lose the reagent probe fixed
legs and springs.

7) After remove the reagent probe, please insert the needle detector into the reagent probe, unclog
repeatedly until it unclogged;

8) Use the syringe to inject the water into the reagent probe connector, and then rinse the inner wall
of the probe until the dirt discharged.

If several attempts to unclog the reagent probe are failed, or the inner wall or outer wall of the
reagent probe has scratches phenomenon, please contact URIT for reagent probe replacement.

9) Install the reagent probe from the position hole, from top to bottom, and then fixed it with spring
fixed legs;

10) Connect the flow path tube;

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Warning

1) Pipe joint must be inserted tightly; otherwise it may burn the circuit board due to
leakage.

2) Be careful, the reagent probe cannot be hooked by the spring, otherwise it may cause
anti-collision function abnormal, the arm cover must be covered tightly, which
guarantee the gap sealed.

11) Install the arm cover;

12) Turn on the instrument test power supply;

13) Open the biochemical management software, and then in menu bar, click Maintenance option;

14) Click Sample adding probe and stirrer cleaning, and then the instrument will automatic clean the
sample adding probe and stirrer, and then reset the reagent probe;

15) Check the reagent probe in rinsing compartment’s position, it must the same as before remove;

If there is still a large deviation, please perform the above operations again, if the problem still cannot
be solved after several attempts, please contact URIT.

Please be sure the serum centrifugation effect is good to avoid block probe. If most of the result is
lower or near to zero, please confirm the probe is block or not.
1) To observe whether there are malfunction, such as lamp go out, water leakage or the probe not
aspirate sample.
2) If the above malfunction is not exist, observe whether there are fibrin in sample or not, and
observe the flow from probe, if no water flow or flow not smoothly, that mean the probe is block.

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Figure 9.6.2-1 block judgement

If the probe is block, do the following steps:

1) Confirm the instrument test power supply has been turned off;

2) Observe sample probe in rinsing compartment’s position, and remember it;

3) Gently upward pull the sample probe arm to the highest point, and then through rotate the rocker
arm to move the sample probe to the easy operation position;

4) Remove the arm cover;

Figure 9.6.2.1-1 Remove the sample probe cover

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5) Disconnect the flow path tube;

Figure 9.6.2.1-2 Remove the sample probe connector

6) Remove the sample probe fixed legs, and then gently lift up the sample probe, and then remove
the sample probe from the position hole, from bottom to top.

Caution
When remove the sample probe fixed legs, please don't lose the sample probe fixed
legs and springs.

Warning
Sample probe can only be replaced by URIT authorized personnel, if you need to
replace the sample probe, please contact URIT.

7) Please insert the needle detector into the sample probe, unclog repeatedly until it unclogged;

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8) Use the syringe to inject the water into the sample probe connector, and then rinse the inner wall
of the probe until the dirt discharged.

If several attempts to unclog the sample probe are failed, or the inner wall or outer wall of the sample
probe has scratches phenomenon, please contact URIT for sample probe replacement.

9) Install the sample probe from the position hole, from top to bottom, and then fixed it with spring
fixed legs;

10) Connect the flow path tube;

Figure 9.6.2.3

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Warning

1) Pipe joint must be inserted tightly; otherwise it may burn the circuit board due to
leakage.

2) If the front end of the pipe joint is damaged, when necessary, a small amount can be
cut.

3) Be careful, the sample probe cannot be hooked by the spring, otherwise it may cause
anti-collision function abnormal, the arm cover must be covered tightly, which
guarantee the gap sealed.

11) Install the arm cover;

12) Turn on the instrument test power supply;

13) Open the biochemical management software, and then in menu bar, click Instrument
maintenance option;

14) Click Sample adding probe and stirrer cleaning, and then the instrument will automatic clean the
sample adding probe and stirrer, and then reset the sample probe;

15) Check the sample probe in rinsing compartment’s position, it must the same as before remove;

If there is still a large deviation, please perform the above operations again, if the problem still cannot
be solved after several attempts, please contact URIT

9.6.4 Replace the light source lamp

The light source lamp’s filament position has a great impact on the optical performance of the
instrument optical path, if the light source lamp damaged or exceed the rated life (2000 hours), then
the light source lamp must be replaced.

Warning
1) Light source lamp can only be replaced by URIT authorized personnel, if you need to
replace the light source lamp, please contact URIT.

2) Before replace the optical system’s light source lamp, please disconnect the analyzer
host main power, and wait at least 15 minutes until the light source to cool. Before the
light source cooling, please do not touch, it may cause burns.

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9.7 Preventive Maintenance

Regularly check the instrument to ensure the instrument performance. So we suggest perform
preventive maintenance. Preventive maintenance is not just a simple inspection and maintenance; it
should also include the following contents:

1) Daily check and regular check

2) Regular maintain and replace the long time use and easy wear parts

3) Ensure that the spare parts are sufficient and meet the need

4) Improve instrument operating environment, such as temperature, humidity, water quality, dust,
gas, small animal, insect, foreign matter, etc.

9.8 Handling for Long Time Power Off

If the instrument will not use for a long time or more than two days (does not include two days),
before power off and power on, please perform the following steps:

1) Before power off, please empty the instrument flow path system, empty and clean the distilled
water bucket, waste solution bucket and detergent bucket;

2) Before power on, please clean the distilled water bucket and detergent bucket, and then adding
the distilled water into the distilled water bucket, and adding the detergent into the detergent
bucket;

3) In software operation main interface, click Instrument maintenance button, to rinse the flow
path system and reaction cup at least 2 times.

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CHAPTER 10 Storage And Transportation

10.1 Storage

The wrapped instrument should be stored at a ventilated room, with temperature range from -40℃ to
55℃, ambient humidity not exceeding 95%, atmosphere pressure is 75kPa to 106kPa. DO NOT
store the instrument along with any poison or corrosive.

The instrument stored for over one year may fall short of the precision of measurement. Therefore, it
is suggested to perform mechanical calibration and alignment procedure when using the instrument.

CAUTION

Please contact URIT to perform calibration for mechanism of the instrument.

10.2 Transportation

After the analyzer put into packing container, you may choose any way to transport it, but it cannot be
inverted, and during the transportation should be moisture proof, sun block and anti-collision. Do not
ship the analyzer with any poison or corrosive.

CAUTION

The transportation temperature is -40℃ to 55℃, and relative humidity is less than 95%, the
atmosphere pressure is 75kPa to 106kPa.

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CHAPTER 11 Alarm and Troubleshooting

This chapter lists the various malfunctions, along with probable causes and recommended remedies
to correct the problem quickly and easily. If the problem still exists after following the recommended
remedy, contact URIT for Technical support.

11.1 Troubleshooting Guide

To eliminate malfunction easily and correctly, users should read through the Operating Manual and
be familiar with the routine operation and maintenance of analyzer.

In general, there are three steps to handle with malfunction:

 Step 1: Confirming Malfunction

Users should not only confirm the malfunction, but also clearly know what the normal status should
be when the malfunction is eliminated.

 Step 2: Classifying Malfunction

Malfunction can be categorized into three types.

 Malfunction relating to hardware

 Malfunction relating to software

 Malfunction relating to operation and analyses.

If malfunction relates to the hardware or software, contact your local distributor or URIT. If
malfunction relates to the operation and analyses, refer to the troubleshooting table below for
solution.

 Step 3: Eliminating Malfunction

The maintenance engineer authorized by URIT takes proper measures to correct the problem.

Users can also eliminate the malfunction under the directions of maintenance engineer.

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11.2 Obtaining Technical Help

Our Customer Service Office is available to help if the problem is beyond the scope of this manual or
if you need more technical assistance from URIT. Before calling, please identity the following
information:

1) The instrument’s model;

2) The serial number of instrument;

3) The specific symptom and operating condition;

4) The data and report relating to the problem.

11.3 Troubleshooting Method

The troubleshooting table below presents the various problems and malfunctions that may occur
during operation. If the problem cannot be solved through the recommended methods, contact URIT
please.

Note
For replacing parts of the instrument, refer to Appendix A.

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Table 11.1 Troubleshooting

SN PHENOMENON POSSIBLE CAUSE REMEDY

1) Incorrect connection with Connect power cord correctly.


power cord. Check if the power receptacle is in good
condition.
2) No electricity with power
Replace fuse(8A)
receptacle.
Instrument is not Confirm select the correct connector at
1 active when 3) The safety fuse is fusing [System parameter—Communication
power is on. port and hospital name setting]]
4) Improper COM interface
is selected. Make sure the RS232 communication
cable is connected to PC correctly.
5) Communication cable
If the problem still persists, contact your
error. local distributor or URIT.

1) Select [Maintenance—Cuvette rinse],


Check if reaction cuvettes are dirty or
damage. Replace them if necessary
Cuvette blank Cuvette dirty or damage
2
error Light source aging 2) Replace light source.

3) If the problem persists, contact your


local distributor or URIT.

1) Check or replace the lamp holder


1) Bad contact of lamp holder. 2) Replace the lamp.
3 Lamp is dark
2) Lamp is burned out. 3) If the problem persists, contact your
local distributor or URIT.

Water or 1) Reconnect the tube or replace it.


detergent does 1) Flow path tube is leaky.
not come out 2) Unclog the tube.
2) Flow path tube is clogged.
4 through the 3) Replenish water or detergent.
probe washing 3) Water or detergent is used
pool or stirrer up. 4) If the problem persists, contact your
washing pool local distributor or URIT.

1) Air leaks in the flow paths.


1) Check flow path tubes. Reconnect or
Inaccurate
aspirated 2) Air bubbles are formed in replace tubes if necessary.
5 volume of meter regulator. 2) Reconnect meter regulator. Eject air
reagent or 3) Probe is clogged. bubbles.
sample.
4) Magnetic valve problem 3) Unclog or replace probe.

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4) Check magnetic valve and replace it


if necessary.

5) If the problem persists, contact your


local distributor or URIT.

1) Reconnect the tube or replace it.

1) Flow path tube is leaky. 2) Unclog the tube.


Adding or
6 draining water is 2) Flow path tube is clogged. 3) Check the vacuum pump and replace
abnormal it if necessary.
3) Vacuum pump error.
4) If the problem persists, contact your
local distributor or URIT.

1) Check the wire of light coupling or


A certain
Light coupling is short replace the light coupling.
7 movable part is
circuited or broken. 2) If the problem persists, contact your
out of control
local distributor or URIT.

1) Check the liquid level sensor board


1) Liquid level sensor board is and replace it if necessary.
defective. 2) Reconnect the liquid level sensor
Liquid level
2) Bad contact with liquid board.
8 sensor is out of
level sensor board. 3) Replace the liquid level sensor power
order
3) Liquid level sensor power cord.
cord is damage. 4) If the problem persists, contact your
local distributor or URIT.

1) Select maintenance→cuvette rinse to


1) Cuvette is dirty or check whether cuvette is dirty. Clean or
breakage. replace the cuvette.

2) Inaccurate aspirated 2) Check sample injector and tube


volume of reagent or sample. whether leakage existed.
Inaccurate test 3) Lamp is deteriorated. 3) Replace the lamp.
9 result or poor
repeatability. 4) Parameters of analytical 4) Set the parameter follows the
item are set improperly. operation manual. Make sure the
instrument is well grounded by means
5) Ground wire is absent with of the ground pole.
power supply.
5) Check if the reagent is certified.
6) Reagent problem. Perform recalibration.

6) If the problem persists, contact your

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local distributor or URIT.

1) Stirrer motor is broken. 1) Replace the stirrer motor.

2) Bad contact of stirrer 2) Reinstall the stirrer motor.


Stirrer does not
10 circuit. 3) Replace the stirrer power cord.
work.
3) Stirrer power cord is 3) If the problem persists, contact your
damage. local distributor or URIT.

1) Turn the instrument off, slowly rotate


the sample adding probe and
sample tray, check whether the
rotation is all right.
1) Communication error.
2) Open the instrument, enter
2) Mechanical parts are loose maintenance → instrument
Abnormal motor or stuck. parameter setting to adjust
11 parameter. (Only accessible to
movement 3) Light coupling joint of
professional person authorized by
motor is loose.
URIT).
4) Light coupling is defective.
3) Check the light coupling and replace
it if necessary.

4) If the problem persists, contact your


local distributor or URIT.

1) Check the flow path tube. Reconnect


or replace the tube if necessary.

1) Flow path tube is leaky. 2) Check the magnetic valve and


Water leaks replace it if necessary.
12 from nozzles of 2) Magnetic valve problem.
cuvette cleaner. 3) Check the vacuum pump and replace
3) Vacuum pump problem. it if necessary.

4) If the problem persists, contact your


local distributor or URIT.

1) Check the flow path tube. Reconnect


or replace the tube if necessary.
1) Flow path tube is leaky. 2) Check the magnetic valve and
Water drops replace it if necessary.
2) Magnetic valve problem.
13 adhere to the tip
of probe. 3) The exterior of probe is 3) Check the exterior of probe. Clean or
dirty or scathed. replace the probe if necessary.

4) If the problem persists, contact your


local distributor or URIT.

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1) Check if the reagent tray is sealed


completely.

2) Check if the heat dissipation device


works normally.
Reagent tray The cooling system is failed 3) Check if the refrigerants are used up.
14 cannot be or cooling temperature is not
cooled. low enough. 4) Check if the circulation system of the
cooling device works normally.

5) Replace the peltier.

6) If the problem persists, contact your


local distributor or URIT.

1) Waste full 1) Empty the waste solution barrel


Instrument
15 2) Inadequate distilled water 2) Add distilled water
alarm sound
3) Inadequate detergent 3) Add detergent

1) Instrument parameters 1) Enter maintenance → instrument


parameter setting to adjust parameter.
are set improperly.
(Only accessible to professional person
2) Human carelessness, authorized by URIT).
such as reagent bottle lid 2) Read through the Operating Manual
is not opened, operator and avoid human mistake.
does not proper 3) Do not put foreign objects on the
operation. operation panel.
Probe and stirrer
16
collision 4) Check if the motor is installed and
3) Put foreign objects on the
works properly.
operation panel.
5) Check the light coupling and replace
4) Motor problem. it if necessary.

5) Light coupling error. 6) Lock screw or readjust the degree


of tightness for belt.
6) Mechanism or belt is
7) If the problem persists, contact your
loose. local distributor or URIT.

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11.4 Test result data alarm

Data alarm: Mark the abnormal test results and its possible cause. And then for you make the further
judge according to the mark information. Data alarm is not necessarily malfunction, but it will affect
the test results. Therefore, we need to pay special attention to. Detailed result mark shown in the
following table:

Table 11-2 Test result data alarm

Mark Description Possible cause Solution

Alarm item’s first


Please timely replenish the first
Alarm item’s first reagent is insufficient
Lack of R1 reagent, and then retest this alarm
reagent is insufficient which cannot perform
item
the normal test

When alarm item’s


Alarm item’s result is result is beyond the
Exceed Perform the pre-dilution test for
beyond the scope of scope of reagent linear,
linear range this item again
reagent linear then the test result is
abnormal value

1) Check to make sure that the


first reagent bottle is in the same
The alarm item’s first level as other reagent bottles;
The alarm item’s first
reagent sampling reagent sampling has 2) Check whether the first reagent
R1 position abnormal,
been interfered, unable sample adding probe is too
interference
unable to normal to normal adding sensitive, check whether the
adding sample sample current environment humidity is
too big;

3) Retest the alarm item.

Please timely replenish the


Lack of Alarm item’s sample
Alarm item sample, and then retest this alarm
sample volume is insufficient
item

Alarm item’s sample


Please timely replenish the
S position Alarm item’s sample volume is insufficient
sample, and then retest this alarm
interference volume is insufficient which cannot perform
item
the normal test

Alarm item’s second Alarm item’s second Please timely replenish the
Lack of R2 reagent is insufficient reagent is insufficient second reagent, and then retest
which cannot perform
this alarm item
the normal test

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Operating manual

1) Check to make sure that the


first reagent bottle is in the same
The alarm item’s first level as other reagent bottles;
The alarm item’s first
reagent sampling reagent sampling has 2) Check whether the first reagent
R2 position abnormal,
been interfered, unable sample adding probe is too
interference
unable to normal to normal adding sensitive, check whether the
adding sample sample current environment humidity is
too big;

3) Retest the alarm item.

Alarm item’s reaction


substrates are almost
run out, absorbance
increase or decrease
exceed the absorbance
change range, which
Alarm item appears makes the monitoring
substrate Perform the pre-dilution test for
substrate exhaustion period’s absorbance
exhaustion this item again
during the test. deviate from the linear,
makes the
determination results
become unreliable, for
more information,
please refer to chapter
7.2.1

Diluent is insufficient
Lack of which affect the Diluent has not been
Please timely replenish the diluent
dilution pre-dilution timely replenished
operation

Alarm item
measurement point is
too long or incubation 1) Adjust the incubation time to
time is too long, not to advance the monitoring period
Alarm item test was
reach the monitoring
Time out not completed 2) Adjust the measurement point
period or monitoring
before cleaning to make the monitoring period
period is not over yet
before cleaning, cause become shorter
the software still
calculating

dilution Abnormal dilution Alarm item cannot 1) Check to make sure that diluent
position sample absorption, perform the normal bottle is in the same level as other
interference cannot perform dilution sampling reagent bottles;

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Operating manual

normal predilution 2) Check whether the first reagent


sample adding probe is too
sensitive, check whether the
current environment humidity is
too big;

3)Retest the alarm item.

For nonlinear
calibration item, if the
results beyond the 1) Trust this results;
Exceed Alarm item’s result is scope of calibration
calibration beyond the scope of value which cannot be 2) According to the situation
range calibration value analysis whether the sample item
guaranteed
needs to do predilution test.
(calibration problem),
so the alarm is given

Only appeared in the


One point calibration
calibration test
item needs to set the 1) Recalibration;
results, and the
calibration factor range,
Exceed result is beyond the 2) Check to see if the calibration
in order to avoid test
factor range scope of a given solution has been expired or
results abnormal which
factor, the calibration invalid.
caused by abnormal
factor may be
factor
abnormal.

217
Appendix A Replaceable component

SN Name Remark
1 Reaction Cuvette Replacing the cuvettes every 3 months or by needs
2 Reaction Cuvette bracket Replacing the cuvettes every 3 months or by needs
Replacing when it’s using time exceeded 2000 hours
3 Light Source Lamp
or system prompt to replace
4 Teflon Tube
5 PU Tube
Sample probe, reagent probe; replacing when it is
6 Probes
damaged or bend
7 Step Motor Replacing when it is failure
8 Vacuum Pump Replacing when it is failure
9 Solenoid Valve Replacing when it is failure
10 Temperature Sensor Replacing when it is failure
11 Temperature Controller Replacing when it is failure
Replacing when its working time exceeded 40,000
12 Cooling fan
hours
Main Replaceable Optional Accessories
13 K electrode (optional)
14 Li electrode (optional)
15 Na electrode (optional)
16 Cl electrode (optional)
17 Reference electrode (optional)
18 Isolation electrode (optional)

Caution
Please use accessories specified by URIT for instrument maintenance and accessories
replacement. Please maintenance or repair by a service agent approved or authorized by
URIT.
All the consequences caused by use or replace the accessories not approved by URIT,
URIT will not undertake any responsibility

Caution

Above Replaceable component list is for reference only, for specific replace the URIT has
the final explanation right.

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Operating manual

Appendix B Biochemical test items list

Provide the full name of biochemical test items for reference.

No Item English Name

1 AMY Amylase

2 ALT Alanine aminotransferase

3 UA Uric Acid

4 GGT Glutamyltransferase

5 DB Bilirubin direct

6 AST Aspartate amino transferase

7 CHE Cholinesterase

8 LDH Lactate dehydrogenase

9 ALB albumin

10 TG Triglyceride

11 ALP Alkaline phosphaatase

12 TP Total protein

13 CHOL Cholesterin

14 HBDH Hydroxybutyrate dehydrogenase

15 CRE Creatinine

16 TB Total Bilirubin

17 HDL_C High-density cholesterol

18 LDL_C Low-density cholesterol

19 APOA_1 Serum apolipoprotein A1

20 APOB Serum apolipoprotein B

21 CO2 Carbon dioxide

22 TBA Total bile acid

23 P Phosphor

24 CK Creatine Kinase

25 CK_MB Creatine kinase-MB isoenzyme

219
Operating manual

26 UREA Urea

27 GLU Glucose

28 Cr Creatinine

29 Li Lithium

30 Na Natrium

31 K Kalium

32 Cl Chlorine

220

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