BCA-1000 用户手册英文 1041180 2019-09 C.1

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The User Manual is applicable to Automatic Blood Coagulation Analyzer (model: BCA-1000) (hereinafter
referred to as the Analyzer).
Explanation
Dear users, thanks for purchasing our Automatic Blood Coagulation Analyzer (model: BCA-1000).
Please read the manual carefully before operation as incorrect operation may affect the accuracy and precision of
test results and even cause the damages of the Analyzer or personal injury.
After reading, please reserve the manual properly for reference at any time.
Manufacturer: DIRUI INDUSTRIAL CO., LTD.
Manufacturer Address:
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95 Yunhe Street, New & High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of China
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Production Address:
3333 Yiju Road, New & High Tech. Development Zone Changchun, Jilin 130103, the People’s Republic of China
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Place of Production: Changchun, China
Tel: 400 811 6695 400 811 6605

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Website: http://www.dirui.com.cn
E-mail: dirui@dirui.com.cn
Complaints Hotline: 0431-81935326 85177245
Fax: 0431-85173354
Date of Production: See the label.
Service Life: 7 years
Compiled/Revised on: 09-2019

Caution
● The Analyzer shall be used by professional medical examination personnel or trained doctors, nurses and testers.
● As the Analyzer has biological and chemical risks, the operator shall be trained and use personal protective
apparatuses to reduce the risk.
● Only trained operators are allowed to conduct dangerous operation, such as moving parts.
● The Analyzer shall be controlled with a special software designated by the company. Installation of other software
or hardware on the computer may affect the normal operation of the Analyzer. Please do not operate other software
during the operation of the Analyzer.
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● As the Analyzer may have dust accumulated on its surface during its long-term storage, its surface shall be
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cleaned with a clean soft cloth or gauze gently and a small amount of detergent can be used if necessary. Please cut
off the power supply first before the cleaning of the Analyzer. Please close the upper cover of the Analyzer when the
Analyzer is not operated.
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● Please do not wipe the surface of the Analyzer with any organic solvent.
● For the usage and storage of relevant samples, reagent, QC solution and calibration solution, please refer to their
manuals.
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● The operator is obligated to follow national and local regulations on discharge and treatment of the reagent, waste
liquid, waste sample and consumables.
● Please treat the waste liquid and the consumables of the Analyzer according to regulations about medical waste,
infectious waste and industrial waste.
● Local printer shall be used to print the reports and charts.
● Under an environment with low transportation or storage temperature or relative humidity greater than 70%, the
Analyzer shall be turned on for testing only after it is stored in a normal working environment for 24 hours.
Warning
● The protection measures provided for the Analyzer may become invalid if the Analyzer is not used according to
the manual.
● The Analyzer shall be used under a well-grounded condition, independent power supply shall be used and the
input voltage shall meet the requirements of the Analyzer.
● Do not pull or insert the plug with wet hands as it may cause electric shock.
● Do not tread on, warp or pull the wires and cables as they may break and cause a fire.
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● Before the power supply for the Analyzer is cut off, no personnel except from the professional maintenance
personnel of the company are allowed to open the rear cover plate and side cover plate.
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● If any liquids enter the Analyzer or the internal pipeline has liquid leakage, please turn off the master power
supply for the Analyzer immediately and contact the customer service personnel of the company in a timely
manner.
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● Please do not touch the moving components such as probe and mechanical arm when the Analyzer is operating.
Please do not put your hands in an open component as it may cause personal injury or damages of the Analyzer.
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● The Analyzer shall be regularly maintained in strict accordance with the manual, or the Analyzer may have faults
or its test precision and accuracy of the Analyzer may be affected.
● Please use the Analyzer under conditions regulated in the manual. If not, the Analyzer may not operate normally,
the test results may not be reliable, the components of the Analyzer may be damaged and personal injuries may be
caused.
● Please do not use combustible goods around the Analyzer.

Statement
Dirui has the final interpretation right of the manual.
Dirui declares that it will be responsible for the safety, reliability and performances of the Automatic Blood
Coagulation Analyzer (model: BCA-1000) only if all the following requirements are met.
(1)The installation, commissioning, improvement and repair of the Analyzer are undertaken by professional
personnel of Dirui.
(2)Relevant electrical equipment complies with national standards.
(3)The Analyzer is operated according to the manual.
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No further notice will be provided in case of any changes to the software interface.
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User manual
Contents
Chapter 1 Brief introduction..........................................................................................................1-1

1.1 Overview .......................................................................................................................................................... 1-1
1.2 Major indicators ............................................................................................................................................. 1-1
1.3 Composition of the Analyzer.......................................................................................................................... 1-2
1.3.1 Appearance of the Analyzer............................................................................................................................................... 1-2
1.3.2 System composition of the Analyzer ................................................................................................................................. 1-6
1.4 Structure and functions of the Analyzer ....................................................................................................... 1-6
1.4.1 Operation Part ................................................................................................................................................................... 1-6
1.4.2 Analysis Part...................................................................................................................................................................... 1-6
1.5 Symbols .......................................................................................................................................................... 1-15
1.6 Identifications................................................................................................................................................ 1-17
1.7 Working principle of the Analyzer .............................................................................................................. 1-18
1.7.1 Analysis process .............................................................................................................................................................. 1-19
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1.7.2 Characteristics of photometry .......................................................................................................................................... 1-20
Chapter 2 Installation of the Analyzer ..........................................................................................2-1
2.1 Installation requirements ............................................................................................................................... 2-1
2.1.1 Space requirements............................................................................................................................................................ 2-1
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2.1.2 Environmental requirements.............................................................................................................................................. 2-1
2.1.3 Power requirements ........................................................................................................................................................... 2-2
2.1.4 Requirements for pure water ............................................................................................................................................. 2-2
2.2 Unpacking........................................................................................................................................................ 2-2
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2.2.1 Unpacking steps ................................................................................................................................................................ 2-2

2.2.2 Removal instructions for the outer packaging of the host.................................................................................................. 2-3
2.2.3 Analyzer internal fixing devices removal instructions ....................................................................................................... 2-4
2.2.4 Way of carrying ................................................................................................................................................................. 2-9
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2.3 Installation process ......................................................................................................................................... 2-9

2.3.1 Installation of the Analyzer ............................................................................................................................................... 2-9
2.3.2 Power connection ............................................................................................................................................................ 2-10
2.3.3 Connection of peripheral equipment ............................................................................................................................... 2-10
2.3.4 Software installation and uninstallation........................................................................................................................... 2-10
2.3.5 Commissioning of the Analyzer ...................................................................................................................................... 2-10
2.3.6 Test of performance ......................................................................................................................................................... 2-10
2.3.7 Training for medical personnel ........................................................................................................................................ 2-10
2.3.8 Fill-in of Installation Acceptance Report ......................................................................................................................... 2-10
2.4 Accessory devices .......................................................................................................................................... 2-10
2.4.1 Barcode reader................................................................................................................................................................. 2-10
Chapter 3 Operation of software ...................................................................................................3-1
3.1 Software installation and uninstallation ....................................................................................................... 3-1
3.1.1 Software install .................................................................................................................................................................. 3-1
3.1.2 Software uninstallation ...................................................................................................................................................... 3-2
3.2 System login..................................................................................................................................................... 3-4
3.3 Software interface description ....................................................................................................................... 3-6
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3.3.1 Window composition ......................................................................................................................................................... 3-6

3.3.2 Functions of keyboard ....................................................................................................................................................... 3-8
3.4 How to operate the software .......................................................................................................................... 3-8
3.4.1 Cursor movement .............................................................................................................................................................. 3-8
3.4.2 Selection of buttons ........................................................................................................................................................... 3-8
3.4.3 Window opening ............................................................................................................................................................... 3-8
3.4.4 Operation of list box and scroll bar ................................................................................................................................... 3-9
3.4.5 Radio button and check box ............................................................................................................................................ 3-10
Chapter 4 System management .....................................................................................................4-1
4.1 Information management .............................................................................................................................. 4-1
4.1.1 Hospital information.......................................................................................................................................................... 4-1
4.1.2 Patient information ............................................................................................................................................................ 4-4
4.1.3 Other information .............................................................................................................................................................. 4-5
4.2 System log ........................................................................................................................................................ 4-7
4.3 User management ........................................................................................................................................... 4-7
4.3.1 User management .............................................................................................................................................................. 4-7
4.3.2 Permission setting.............................................................................................................................................................. 4-8
4.3.3 Common function setting .................................................................................................................................................. 4-9
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Chapter 5 System Setting ...............................................................................................................5-1
5.1 Item maintenance ........................................................................................................................................... 5-1
5.2 Item parameters .............................................................................................................................................. 5-2
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5.2.1 Analysis parameters........................................................................................................................................................... 5-3
5.2.2 Calibration parameters....................................................................................................................................................... 5-7
5.2.3 Range parameters .............................................................................................................................................................. 5-8
5.3 Combination .................................................................................................................................................. 5-10
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5.4 Printing setting .............................................................................................................................................. 5-10

5.5 Communication setting ................................................................................................................................ 5-11
5.6 Other information ......................................................................................................................................... 5-13
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5.6.1 System ............................................................................................................................................................................. 5-13

5.6.2 Coagulation ..................................................................................................................................................................... 5-16
5.7 Reagent setting .............................................................................................................................................. 5-16
5.8 Software interface setting............................................................................................................................. 5-17
Chapter 6 Calibration Information ...............................................................................................6-1
6.1 Calibration registration.................................................................................................................................. 6-1
6.1.1 Manual registration of calibration solution ........................................................................................................................ 6-2
6.1.2 Modify calibration parameters........................................................................................................................................... 6-3
6.1.3 Delete calibration item ...................................................................................................................................................... 6-4
6.1.4 Calibration test .................................................................................................................................................................. 6-4
6.2 Calibration result ............................................................................................................................................ 6-4
Chapter 7 QC Management ...........................................................................................................7-1
7.1 QC rules ........................................................................................................................................................... 7-2
7.2 QC registration ............................................................................................................................................... 7-3
7.2.1 Manual registration of control material ............................................................................................................................. 7-3
7.2.2 Delete QC item .................................................................................................................................................................. 7-4
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7.2.3 QC test............................................................................................................................................................................... 7-4

7.3 Daily QC .......................................................................................................................................................... 7-5
7.3.1 Daily QC data .................................................................................................................................................................... 7-5
7.3.2 QC chart for daily QC ....................................................................................................................................................... 7-6
7.4 Monthly QC..................................................................................................................................................... 7-8
7.4.1 Monthly QC data ............................................................................................................................................................... 7-8
7.4.2 QC chart for monthly QC .................................................................................................................................................. 7-9
Chapter 8 Operation of the Analyzer ............................................................................................8-1
8.1 Operation description..................................................................................................................................... 8-1
8.2 Detailed operation........................................................................................................................................... 8-2
8.2.1 Check before test ............................................................................................................................................................... 8-2
8.2.2 Connect power cable and log in the software .................................................................................................................... 8-2
8.2.3 Confirm the state of the Analyzer ...................................................................................................................................... 8-2
8.2.4 Confirm analysis conditions .............................................................................................................................................. 8-5
8.2.5 Prepare reagent .................................................................................................................................................................. 8-6
8.2.6 Registration of calibration item and QC item .................................................................................................................. 8-10
8.2.7 Register of sample ........................................................................................................................................................... 8-10
8.2.8 Prepare test ...................................................................................................................................................................... 8-15
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8.2.9 During test ....................................................................................................................................................................... 8-16
8.2.10 Confirmation of test results ........................................................................................................................................... 8-21
8.2.11 Recheck of sample ......................................................................................................................................................... 8-31
8.2.12 Analysis ended............................................................................................................................................................... 8-34
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Chapter 9 System Help ...................................................................................................................9-1
9.1 Use of System Help ......................................................................................................................................... 9-1
Chapter 10 System Maintenance .................................................................................................10-1
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10.1 Preparation before system maintenance ................................................................................................... 10-1

10.1.1 Tools and instruments .................................................................................................................................................... 10-1
10.1.2 Pure water...................................................................................................................................................................... 10-1
10.1.3 Detergent ....................................................................................................................................................................... 10-1
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10.2 Analyzer resetting ....................................................................................................................................... 10-1

10.3 Application of “Maintenance” window ..................................................................................................... 10-1
10.3.1 Mechanical motion check .............................................................................................................................................. 10-2
10.3.2 Tubing drainage ............................................................................................................................................................. 10-3
10.3.3 Tubing exhaust .............................................................................................................................................................. 10-3
10.3.4 Vertical check for probe................................................................................................................................................. 10-4
10.3.5 Horizontal check for probe ............................................................................................................................................ 10-4
10.3.6 Check clamp position .................................................................................................................................................... 10-5
10.3.7 Check photometer.......................................................................................................................................................... 10-5
10.3.8 Probe rinse ..................................................................................................................................................................... 10-6
10.3.9 Reagent shaking check .................................................................................................................................................. 10-6
10.3.10 Tubing Automatic Rinse .............................................................................................................................................. 10-7
10.3.11 Waste Liquid Tube Rinse ............................................................................................................................................. 10-7
10.4 System maintenance position and parts.................................................................................................... 10-8
10.4.1 Clean, check and replace parts regularly ....................................................................................................................... 10-8
10.4.2 Spare parts for regular replacement and maintenance ................................................................................................... 10-9
10.5 Maintenance methods................................................................................................................................. 10-9
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10.5.1 Probe cleaning ............................................................................................................................................................... 10-9

10.5.2 Rinsing of incubation and test position........................................................................................................................ 10-10
10.5.3 Reagent chamber cleaning ........................................................................................................................................... 10-10
10.5.4 Sample chamber cleaning ............................................................................................................................................ 10-10
10.5.5 Pure water tank cleaning ............................................................................................................................................. 10-10
10.5.6 Pure water tank large hole filter cleaning .................................................................................................................... 10-11
10.5.7 Detergent II filter cleaning .......................................................................................................................................... 10-11
10.5.8 Cleaning of cooling fan and dust cover ....................................................................................................................... 10-11
10.5.9 Syringe pump .............................................................................................................................................................. 10-12
10.5.10 Overheating protection device check......................................................................................................................... 10-12
10.5.11 Liquid level protection device ................................................................................................................................... 10-12
10.5.12 Maintenance of the Analyzer before stop and storage description ............................................................................. 10-13
10.5.13 Cleaning and maintenance of the Analyzer ............................................................................................................... 10-13
10.5.14 Waste treatment ......................................................................................................................................................... 10-14
10.6 Treatment of scrapped analyzer .............................................................................................................. 10-14
Chapter 11 Alarm and Treatment of the Analyzer..................................................................... 11-1
11.1 Type of alarm message ................................................................................................................................ 11-1
11.2 Solutions for non-alarm faults ................................................................................................................... 11-1
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11.2.1 Abnormal data of non-alarm faults ................................................................................................................................ 11-1
11.2.2 Faults of the Analyzer without alarm ............................................................................................................................. 11-1
11.3 Alarm message and solutions ..................................................................................................................... 11-2
Chapter 12 Transportation and storage ......................................................................................12-1
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12.1 Transportation ............................................................................................................................................ 12-1
12.2 Storage ......................................................................................................................................................... 12-1
Appendix A Warranty .................................................................................................................... A-1
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Appendix B Product Description .................................................................................................. B-1

Appendix C Use instructions of LIS network interface (version No. V1.04) ............................ C-1
Appendix D Parts List ................................................................................................................... D-1
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Appendix E Performance Indexes ................................................................................................ E-1

Appendix F Statement on Electromagnetic Compatibility......................................................... F-1
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User manual
Chapter 1 Brief introduction
1.1 Overview
The Automatic Blood Coagulation Analyzer (model: BCA-1000) is a desk-type test instrument with an external
computer and it is used for emergency treatment with priority.
The Analyzer has functions including automatic sample dispensing, reagent dispensing, interference shielding,
mixing, preheating, reaction monitoring, rinsing and results calculation, display and printing. It fully imitates and
substitutes manual operation, which not only improves work efficiency, but also reduces test error and improves the
accuracy and precision of test results.
Scope of application: Use clotting assay, chromogenic substrate assay or immunoturbidimetric assay for clinical
determination of prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT),
fibrinogen (FIB), coagulation factor, etc.
Contraindications: None.
1.2 Major indicators

Items Indicators
Reaction temperature 37.0℃
Basic
characteristics
Control accuracy of temperature
Test items
Test methods
±1.0℃
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At most 8 items can be simultaneously tested.
Clotting assay, chromogenic substrate assay, and
immunoturbidimetric assay
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Test speed PT single-item test: 100 samples/ hour
With refrigerated reagent chamber, 20 refrigerated reagent positions
Reagent chamber, reagent
Normal-temperature reagent rack, 3 normal-temperature reagent
position
positions
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Reagent volume 20μL~175μL

Reagent system
Specifications of reagent bottle 5mL, 15mL, and 50mL
Storage temperature of reagent Refrigerated reagent ≤16.0℃
Reagent liquid level sensor Integrated with probe
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Sample chamber, sample

40 samples can be placed
position
Sample type Plasma
One built-in barcode reader (laser), automatically scanning sample,
Sample system reagent barcodes;
Barcode identification system
One external barcode reader (red light), manually scanning barcodes
(optional).
Sample volume 5μL~170μL
Sample liquid level sensor Integrated with probe
Port Network port
Data system Computer configuration Optional computer and printer

Connection with LIS/HIS
It is supported
system
Incubation and test positions Totally 16, 8 incubation positions and 8 test positions
Volume of cuvette 600 μL
Analysis system
Optical system Light-emitting diode, photodiode
Real-time QC, daily QC and inter-day QC with multi-concentration
QC
method
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Items Indicators
Weight 75kg
Complete machine
Power consumption 450VA
system
Outline dimensions 660mm×475mm×554mm(L×W×H)
Normal operating conditions of the Analyzer

(1)Supply voltage: 220/230V~
(2)Frequency: 50/60Hz
(3)Environmental temperature: 10℃~30℃
(4)Relative humidity: no more than 70%
(5)No magnetic field nearby
(6)Prevent direct strong light exposure
(7)Atmospheric pressure: 75kPa~106kPa
1.3 Composition of the Analyzer

1.3.1 Appearance of the Analyzer
1.3.1.1 Front view of the Analyzer
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
1 Upper cover 2 Stop button 3~5 Reagent chamber unit indicator lamps 6 Left front door
7~10 Sample chamber unit indicator lamps 11 Right front door 12 Feeding unit indicator lamp
13 Waste collecting unit indicator lamp 14 Feeding unit indicator lamp 15 Machine state indicator lamp
Fig. 1-3-1 Front view of the Analyzer
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1.3.1.2 View of the Analyzer after the front door is opened
1 15mL reagent bottle rack

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2 5mL reagent bottle rack 3 Sample rack
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4 Feeding box 5 Channel for cup fall-off 6 Waste box
Fig. 1-3-2 View of the Analyzer after the front door is opened
1.3.1.3 Rear view of the Analyzer
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1 2 3 4 5
1 Fan 2 Port for waste liquid level sensor 3 Waste liquid outlet 4 Pure water inlet
5 Port for pure water level sensor 6 Observation window
Fig. 1-3-3 Rear view of the Analyzer
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1.3.1.4 Top view of the Analyzer
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1 Rinsing bath 2 Mechanical arm of probe 3 Normal-temperature reagent position
4 Refrigerated reagent position 5 Sample position 6 Feeding tray
7 Optical unit 8 Channel for cup fall-off 9 Feeding tray 10 Mechanical arm
Fig. 1-3-4 Top view of the Analyzer
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1.3.1.5 Left view of the Analyzer
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1 2 3
1 Detergent Ⅱ bottle (probe outer wall detergent) 2 Detergent shielding case 3 Fan in reagent chamber
Fig. 1-3-5 Left view of the Analyzer
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1.3.1.6 Right view of the Analyzer
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1 Network port 2 Power receptacle 3 Power switch 4 Power indicator lamp

Fig. 1-3-6 Right view of the Analyzer
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1.3.2 System composition of the Analyzer
Three-dimensional
mechanical arm unit
Fluid tube
system
Normal-temperature
reagent rack
Barcode
reader
Reagent
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chamber unit
Sample Power box
chamber unit Optical assembly
Waste unit
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reclaiming unit Feeding

unit
Fig. 1-3-7 System composition
1.4 Structure and functions of the Analyzer

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The host of the Analyzer is composed of sample feeding unit, testing unit, control unit, and data processing unit.
The software system of the analyzer is installed on the computer to form the operation unit of the analyzer, and the
analyzer host is the analysis unit. The two parts are connected through a network cable.
1.4.1 Operation Part
The Operation Part is composed of the host, 19 inch LCD, keyboard, mouse and printer.
Host: Windows 7 (×64), Windows 8.1 (×64) and Windows 10 (×64) operating systems and special application
software and database are installed.
Minimum configuration of computer: Above CPU 2.6GHz dual-core, hard disk above 250G, RAM 4G or above,
integrated graphics card or discrete graphics card 500M or above (DirectX function supported), 100M/1000M
ethernet card.
Display: Display the windows, curves and test data of software of the Analyzer. Resolution 1366×768 (minimum)
or above (optimal resolution 1920×1080).
Keyboard: Control the operation of the Analyzer and input data.
Mouse: Operate software.
Printer: Print the tested data and charts.
1.4.2 Analysis Part
The Analysis Part consists of optical unit, sample chamber unit, reagent chamber unit, three-dimensional
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mechanical arm unit, waste collecting unit, feeding unit and fluid tube unit, which are described below.
1.4.2.1 Optical unit
1 Column 2 Base plate

4 Incubation and test assembly
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3 Temperature control board
5 Shielding box
Fig. 1-4-1 Optical unit
6 AD collecting board
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(1)Composition and functions
a)Composition: Column, base plate, temperature control board, incubation and test assembly, shielding box and
AD collecting board.
b)Functions:
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Thermostatic function: The temperature in incubation area and test area is controlled at (37.0±1.0) ℃.
Testing function: It can test the light intensity variation of tested sample in its reaction process when it passes the
reaction area and convert the signal to electrical signal, and then convert the electric signal to digital signal and
transmit it to the upper computer.
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(2)Specifications
8 incubation positions and 8 test positions. The test positions are provided with 3 test wavelengths. Among the test
positions, 4 are provided with 660nm wavelength, 2 are provided with 405nm wavelength and 2 are provided with
575nm wavelength.
Temperature control: Test area: (37.0±1.0) ℃; incubation area: (37.0±1.0) ℃.
(3)Disassembly
The optical unit can be taken from the host by unscrewing the anchor screws on mounting holes. During installation,
the optical unit shall be connected with the base plate of the machine by fastening the locating pins and anchor
screws between them.
1.4.2.2 Sample chamber unit
● When the Analyzer is operating and the sample chamber unit indicator lamp flashes slowly, the sample
rack indicated by the indicator lamp shall not be operated as it may damage the Analyzer.
● The sample shall be steadily fed and sample fluid spill-out is not allowed in the feeding process.
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1 Sample chamber support assembly 2 Sample chamber assembly 3 External barcode reader
Fig. 1-4-2 Sample chamber unit
(1)Structure and functions of sample chamber
information scanning.
(2)Specifications 疗
The sample chamber is mainly composed of support assembly, sample chamber assembly and external barcode
reader assembly. The sample chamber has functions including sample dispensing, positioning and sample
Test tube: Φ12mm×75mm, Φ12mm×100mm, Φ13mm×75mm, Φ13mm×100mm(±1mm), Φ16mm×75mm(±1mm),

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Φ16mm×100mm(±1mm).
Standard cup: Φ14mm×37mm(±1mm).
Barcode type: Code 128, Code 39, Code 93, Codebar, I2 of 5.
The dead volume of the 2mL standard cup is 150μL.
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(3)Motion
The sample tubes are loaded to the Analyzer manually. After the sample tubes are inserted to the sample rack with
their barcode facing outward, the sample rack will be loaded to the sample chamber through the guide rail at bottom
of the sample chamber and the barcode reader will scan the sample information and position information in the
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loading process.
(4)State description of indicator lamps
a)If the indicator lamp is off, it means the sample rack is not in the sample chamber and operation is allowed.
b)If the indicator lamp is normally on, it means the sample rack is in the sample chamber and operation is
allowed.
c)If the indicator lamp flashes slowly, it means the sample rack is in use and it is not allowed to operate the sample
rack.
d)If the indicator lamp flashes quickly, it means there is a fault and operation can only be conducted after the fault
is removed.
● The barcode reader used for the Analyzer is of Class 2 laser product. During its use, the users shall not
stare at the laser beam as instructed by the Warning and they can turn head or close eyes.
● Users shall not look at the laser beam constantly in case of damages to their eyes.
● The power supply to the Analyzer shall be disconnected before wiping the barcode reader. Please wear
protective glasses if you have to look directly at the laser source.
● If you do not use, control or adjust the device, or execute each step of operation according to the
stipulation, harmful radiant exposure may be caused.
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1.4.2.3 Reagent chamber unit
● When the reagent chamber unit indicator lamp flashes slowly, it means the reagent rack of this row is in
use. Under this condition, please do not pull the test rack of this row as it may cause personal injury or
damages of the Analyzer.
● When the reagent bottles are put in the reagent rack, the barcode on the reagent bottles shall face outward
to ensure that the barcode reader can read the barcode information.
● If too much condensed water is attached to the reagent rack bar code, the bar code reading may fail.
Please dry the condensed water attached to the bar code before use.
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1 Reagent chamber support assembly 2 Mixing assembly 3 Ventilating slot assembly
4 Reagent chamber assembly 5 Adapter 6 15mL reagent rack
Fig. 1-4-3 Reagent chamber unit
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The reagent chamber unit is composed of reagent chamber assembly, reagent chamber support assembly, ventilating
slot assembly and mixing assembly. It has functions including reagent feeding and refrigeration, reagent bottle
information scanning and automatic reagent mixing.
(2)Specifications (number of reagent bottles placed)
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Six 15mL reagent bottles can be placed in the first row of the reagent chamber and the bottles with reagent that
should be mixed are placed at the first and second position in the row. Seven 5mL reagent bottles can be placed on
each reagent bottle rack in the second and third rows, totally 20 reagent positions. The bottle specifications and
adapter use are shown below:
Table 1-4-1
Reagent bottle name Reagent bottle size Adapter
Dirui 15mL reagent bottle Not needed
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Reagent bottle name Reagent bottle size Adapter

Adapter
Dirui 5mL reagent bottle
If you place a 5mL reagent bottle in the first column of the reagent rack, you need to place an adapter. Each
analyzer is equipped with 2 adapters. The usage is as follows: hold the upper end of the adapter and placed
downwards as shown in Figure 1-4-3 in any tank of the first column of the reagent rack, and then put in a 5mL
reagent bottle, so that the barcode on the bottle is exposed at the open end of the adapter.
(3)The bar code reader equipped on the analyzer reads the information of the reagent bottle and its position
information when loading the reagent.
a)If the indicator lamp is off, it means the reagent rack is not in the reagent chamber and operation is allowed.
b)If the indicator lamp is normally on, it means the reagent rack is in the reagent chamber and operation is
allowed.
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c)If the indicator lamp flashes slowly, it means the reagent rack is in use and it is not allowed to operate the
reagent rack.
d)If the indicator lamp flashes quickly, it means there is a fault and operation can only be conducted after the fault
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is removed.
1.4.2.4 Normal temperature reagent position
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Use the original reagent bottle at the normal temperature reagent position and use it according to Figure
1-4-3. Using a non-original reagent bottle or not using it as described above can cause problems such as
probe touch and inaccurate liquid level detection. Excessively high reagent bottles or reagent bottles with
caps can cause damage to the probe.
The normal temperature reagent position is used to store the normal temperature reagents required for the analyzer
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test (such as Detergent I, diluent, etc.). There are 3 positions in the normal temperature reagent position, which
can be used to place the Dirui 50mL, 15mL, and 5mL reagent bottles (15mL and 5mL need to use the matching
adapter) as follows:
1 normal temperature reagent bottle rack 2 adapter 3 reagent bottle 15mL

4 reagent bottle 5mL 5 reagent bottle 50mL
Fig. 1-4-3(a)
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The normal temperature reagent bottle specifications and adapter use for the normal temperature reagent position
are shown in the following table:
Table 1-4-2
Reagent bottle type Reagent bottle size Adapter
Dirui 50mL reagent bottle Not needed
Normal temperature reagent position adapter
疗 Normal temperature reagent position adapter

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The adapter is used as shown in the figure below. First insert one end of the adapter into the normal temperature
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bottle rack, and the other is the opposite. It is recommended to place the 5mL reagent bottle in the middle position
for convenient operation.
Fig. 1-4-3(b)
1.4.2.5 Three-dimensional mechanical arm unit
When the Analyzer is operating, please do not open the upper cover of the Analyzer and do not touch the
three-dimensional mechanical arm as it may cause personal injury or damages of the Analyzer.
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1 Probe Y-axis motion mechanism 2 Probe 3 Mechanical arm Y-axis motion mechanism
4 Mechanical arm mechanism 5 Three-dimensional mechanical arm X-axis motion mechanism
Fig. 1-4-4 Three-dimensional mechanical arm unit
(1)Functions
The probe aspirates a certain amount of sample or reagent in the sample tube and reagent bottle and then dispenses
it to the cuvette. The probe has functions including liquid level detection, reagent heating and touch alarm. The
mechanical arm has functions including mixing the sample and reagent in sample cuvette, taking/ placing/ throwing
the cuvette, as well as alarming for cuvette taking failure.
(2)Specifications
(3)Motion
疗
The probe can aspirate 5μL ~170μL of sample or 20μL~175μL of reagent.
Connection to power supply: The probe executes the motions including rinsing, dispensing reagent to cuvette and
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dispensing sample to cuvette; the mechanical arm executes motions including cuvette adding, cuvette throwing and
mixing.
Analysis: The probe moves, descends and ascends in the sequence of Reagent bottle → cuvette → sample container
→ cuvette → probe rinsing bath. The probe will be rinsed after each sample or reagent dispensing. The motion of
probe when the analysis is started is same as its motion when power supply is connected. The inner and outer walls
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of the probe will be rinsed above the rinsing bath and the probe blockage will also be checked at the same time.
Reset: The motion of the probe is the same as its motion when power supply is connected. The mechanical arm
executes the cuvette throwing motion in test area, incubation area and on the mechanical arm.
Aspiration of sample and reagent: After the probe detects the fluid level, it will continue to lower for 2.1mm and
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then aspirate sample.

(4)Automatic rinsing
Automatic rinsing of probe: After a sample or reagent is dispensed, the probe will return back above the rinsing bath
to rinse the inner and outer walls of probe.
(5)Mechanical motion check
Click “Mechanical motion check”, input the number of check times and then click “Execute”. The Analyzer will
give an alarm in case of any abnormities.
1.4.2.6 Waste collecting unit
● Please wear latex gloves or non-latex examination gloves when discarding cuvettes to prevent biological
hazards!
● When the Analyzer is operating and the waste collecting unit indicator lamp flashes, the waste box shall
not be pulled out to prevent waste cuvette falling to the Analyzer and causing pollution.
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1 Waste box cover plate 2 Waste box 3 Bijection optocoupler 4 Reflection optocoupler
Fig. 1-4-5 Waste collecting unit
(1)Functions
When the Analyzer is operating, the waste collecting unit will alarm to dump cuvette when a used cuvette is stored
and the quantity of cuvette reaches the upper limit.
(2)Specifications
The waste box can hold more than 200 cuvettes.
(3)Motion
疗
If the waste box alarms because the quantity of cuvette reaches the upper limit when the Analyzer is operating, the
waste collecting unit indicator lamp will flash quickly. Under this condition, please take out the waste box and dump
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the cuvettes, and then install the waste box back to the Analyzer.
a)If the indicator lamp is off, it means the waste box is not in the waste collecting unit and operation is allowed.
b)If the indicator lamp is normally on, it means the waste box is in the waste collecting unit and operation is
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allowed.
c)If the indicator lamp flashes slowly, it means the Analyzer is operating and no operation is allowed.
d)If the indicator lamp flashes quickly, it means there is a fault or the waste box is full during the testing process.
Operation should be conducted after the fault is removed or the cuvettes in waste box are dumped.
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1.4.2.7 Feeding unit
● The cuvette shall be kept clean when feeding, or it may affect the test accuracy.
● When the Analyzer is operating and the feeding unit indicator lamp flashes slowly, the drawer indicated by
the indicator lamp shall not be operated as it may damage the Analyzer.
1 Drawer at left side 2 Status check optocoupler 3 Base plate

4 Channel for cuvette fall-off 5 Drawer at right side
Fig. 1-4-6 Feeding unit
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(1)Functions
It provides and stores cuvettes when the Analyzer is operating and it can load cuvette without being shut down. The
channel for cuvette fall-off is the entrance of waste collecting unit and also the channel for cuvette throwing of
mechanical arm.
(2)Specifications
It can contain two cuvette disks. One cuvette disk can contain 36 cuvettes, so the feeding unit can contain 72
cuvettes.
(3)Motion
When the Analyzer is operating and the feeding unit indicator lamp flashes quickly, pull out the drawer indicated by
the indicator lamp and take out the empty feeding box, and then put the feeding box full of cuvettes into the drawer
and close the drawer. Then, the feeding unit indicator lamp will be constantly on and it means the cuvettes’ loading
is finished.
a)If the indicator lamp is off, it means the feeding drawer is not in the feeding unit and operation is allowed.
b)If the indicator lamp is normally on, it means the feeding drawer is in the feeding unit and operation is allowed.
c)If the indicator lamp flashes slowly, it means the Analyzer is operating and no operation is allowed.
d)If the indicator lamp flashes quickly, it means there is a fault or the feeding drawer should be changed during
the testing process. Operation should be conducted after the fault is removed or the drawer is full of cuvettes.
1.4.2.8 Liquid tube unit
疗
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Fig. 1-4-7 Liquid tube unit
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Composition: The liquid tube unit is mainly composed of syringe mechanism, rinsing bath, waste pump, waste
liquid transfer tank assembly, waste liquid tank assembly and pure water tank assembly.
Functions: It can aspirate and dispense the sample and reagent, rinse the inner and outer walls of probe through
rinsing bath, provide the pure water necessary for testing and collect the waste liquid.
(2)Specifications
The syringe pump can aspirate 20μL~175μL reagent, 5μL~170μL sample. The reagent and sample volume can be
set by 1μL to the minimum.
The volume of pure water tank and waste liquid tank is 10L and they have a float for alarm.
(3)Motion
When the fluid tube system is connected to power supply, the fluid tube system will reset automatically and the
syringe pump will move upwards and downwards to exhaust the air bubbles in exhaust pipeline. After the reset, the
machine is under a standby state.
During the analysis,
a)the probe mechanism moves to the sample position and the syringe pump acts to aspirate a certain amount of
sample to the cuvette.
b)The probe moves to the rinsing bath, the syringe moves, the probe tip is cleaned first with pure water, the
probe moves to the normal temperature reagent position to absorb a quantitative amount of Detergent I, then
moves to the rinsing bath and drops to the designated position, the syringe and the syringe pump moves
疗
simultaneously to dispense diluted Detergent II into the rinsing bath to clean the outer wall of the probe, and the
syringe pump moves to dispense Detergent I into the rinsing bath to clean the inner wall of the probe. Finally,
the syringe rinse the inner and outer walls of the probe with pure water, and the waste liquid flows to the waste
liquid can, and the waste liquid pump discharges the waste liquid into the waste liquid tank.
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c)the probe mechanism aspirates a certain amount of reagent to the cuvette.
d)The probe moves to the rinsing bath, the syringe moves, the probe tip is cleaned first with pure water, the
probe moves to the normal temperature reagent position to aspirate a quantitative Detergent I, then moves to the
rinsing bath and drops to the designated position, the syringe and the syringe pump moves simultaneously to
dispense the diluted Detergent II into the rinsing bath to clean the outer wall of the probe, and the syringe pump
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moves to dispense Detergent I into the rinsing bath to clean the inner wall of the probe. Finally, the syringe
rinses the inner and outer walls of the probe with pure water, and the waste liquid flows to the waste liquid can,
and the waste liquid pump discharges the waste liquid into the waste liquid tank.
e)the Analyzer tests relevant items.
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f)if the fluid tube is blocked during testing or rinsing process, the pressure sensor will detect it and send an alarm.
(4)Disassembly
When installing the liquid level sensor and external pipeline, it shall be noted the snap disk at connector should be
pressed first before pulling out the pure water pipe and waste liquid pipe, or the connector may be damaged. When
connecting the sensor, it shall be noted the float color shall be correct to prevent connection error.
1.5 Symbols
Table 1-5-1
Symbols Meaning
BIOLOGICAL RISKS
LASER, DANGER SYMBOL
ALTERNATING CURRENT
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Symbols Meaning
IN VITRO DIAGNOSTIC MEDICAL DEVICE
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
MANUFACTURER
THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON IN VITRO DIAGNOSTIC

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

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

(1)Clotting assay analytical technique
The blood coagulation factor in plasma sample will have reaction after being added to reagent with promoter.
Finally, the sample will form stable cross-linked fibrin and make the turbidity and viscosity in sample change. Then,
the sample can be analyzed according to the start time of sample change.
(2)Chromogenic substrate assay analytical technique
The chromogenic substrate assay is mainly used to test the percent of antithrombin III activity in sample. The main
method is to add heparin and excessive amount of thrombin to sample (the heparin makes the antithrombin III
activity in sample increase and restrict blood clotting activity), and then add chromogenic substrate. After the
chromogenic substrate combines with the residual thrombin in sample, the chromogen will leave from the substrate
and make the solution be yellow. By testing the variation of light beam absorbance of special wavelength in sample,
the percent of antithrombin III activity in sample can be determined.
(3)Immunoturbidimetric assay analytical technique
The immunoturbidimetric assay is mainly used to test the content of fibrin degradation products in sample. The
main method is to add latex particles wrapped with antibody to sample and when latex particles meet fibrin
degradation products, the antigen will combine with antibody and the latex particles in sample will become greater
due to aggregation. As a result, the turbidity of sample will become greater. By testing the variation of light beam
absorbance of special wavelength in sample, the concentration of fibrin degradation products in sample can be
determined.
(1)Clotting assay
疗
The test principle is optical transmission principle. Analytical techniques above have different analytical methods.
The test principle of the clotting assay is shown in Fig. 1-7-1 and Fig. 1-7-2. After the light from the light source
passes through the sample and shines on the photoelectric sensor, the sample will have reaction and the light
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intensity received by the photoelectric sensor will decrease gradually. The time required when the light intensity
attenuates to 50% is just the clotting time of sample.
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迪
Fig. 1-7-1
Fig. 1-7-2
(2)Chromogenic substrate assay
The test principle of the chromogenic substrate assay is shown in Fig. 1-7-3 and Fig. 1-7-4. After the light from the
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light source passes through the sample and shines on the photoelectric sensor, the sample will have reaction and the
absorbance in sample will increase gradually. The antithrombin III content can be calculated according to the
variation of absorbance.
Fig. 1-7-3
疗
Fig. 1-7-4
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(3)Immunoturbidimetric assay
The test principle of the immunoturbidimetric assay is shown in Fig. 1-7-5 and Fig. 1-7-6. After the light from the
light source passes through the sample and shines on the photoelectric sensor, the sample will have action and the
absorbance in sample will increase gradually. The content of fibrin degradation products can be calculated
according to the variation of absorbance.
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迪
Fig. 1-7-5
Fig. 1-7-6
1.7.1 Analysis process

(1)The mechanical arm conducts self-check and clears the waste cuvette left at test position and incubation position.
(2)The fluid tube unit conducts self-check and rinses the inner and outer walls of probe.
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(3)The mechanical arm moves to the feeding position and takes a cuvette to the incubation position.
(4)The probe moves to the diluent position to aspirate diluent (execute this step for items needing dilution) and
moves to the sample position to aspirate sample.
(5)The probe moves to the incubation position to dispense the sample (or diluent+sample) to cuvette and then moves
to the rinsing bath to rinse the inner and outer walls of the probe.
(6)After the incubation, the probe moves to the reagent position to aspirate reagent R1, then moves to the incubation
position to dispense reagent R1 to cuvette and then moves to the rinsing bath to clean the inner and outer walls of the
probe.
(7)After the dispensing of reagent R1, the mechanism arm moves to the incubation position and takes the cuvette for
vibration mixing. After mixing, the cuvette will be put back to the incubation position (multi-reagent) or test
position (single reagent), and the mechanical arm returns back to zero position.
(8)After the incubation, the probe moves to the reagent position to aspirate reagent and moves to the incubation
position to dispense R2, R3 and R4 reagent (until all reagents are dispensed). After each dispensing, it will move to
the rinsing bath to clean the inner and outer walls of the probe.
(9)After the dispensing, the mechanical arm moves to the incubation position and takes the cuvette for vibration
mixing, and then moves to the test position and puts the cuvette at the test position.
(10)The mechanical arm throws the cuvette to waste box after the test.
When several items are tested continuously at a constant pace, it is equal to the overlay of several test processes of a
single item. To prevent conflict in scheduling, the following requirements shall be met.
a)Requirements for continuous test of several items:
疗
Waste cuvette shall not be discarded when adding a new cuvette.
When adding a new cuvette, the sample to be dispensed and the reagent to be dispensed for other item shall
not be tested at a same time.
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The mechanical arm and probe shall not operate at a same time.
When adding a new cuvette, the reagent to be dispensed shall not have cross contamination with the reagent
for last test item.
b)Reduction of test speed:
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The test speed may drop in a test of several items.

1.7.2 Characteristics of photometry
The light from light source will pass through the cuvette used for test first, and then pass through the optical filter
and become a monochromatic light. Then, the monochromatic light will be received by the photoelectric sensor and
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converted into electrical signal and then converted into digital signal after amplification by an amplifier and
analog-digital conversion, i.e. AD value.
The Analyzer has eight test channels for simultaneous testing. They are 4 channels for clotting assay, 2 channels for
chromogenic substrate assay and 2 channels for immunoturbidimetric assay. During the reaction of different items,
they will detect the transmission light intensity of reaction liquid uninterruptedly. In this period, at every 100ms, the
8 test channels will collect the AD value and update them to the upper computer. In the testing process, the cuvette
shall be kept still until the reaction time is up and then the mechanical arm will throw the cuvette to the waste box.
The upper computer will calculate the variation of clotting time or absorbance according to the variation of AD
value in the reaction time period.
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Chapter 2 Installation of the Analyzer
The Analyzer and bundled software can only be installed by Dirui or its authorized personnel.
2.1 Installation requirements
Please install the Analyzer at places meeting the following requirements, otherwise its performance may not
be guaranteed.
2.1.1 Space requirements
The installation and use of the Analyzer shall meet the following requirements.
Min.500
Analysis Part
疗 Operation Part
Min. 1000
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Unit: mm
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Min. 500 Min. 500
Fig. 2-1-1 Diagram for installation space
2.1.2 Environmental requirements

迪
(1)Normal work conditions

a)Environmental temperature: 10℃~30℃.
b)Relative humidity: no more than 70%.
c)Atmospheric pressure: 75kPa~106kPa.
d)The Analyzer shall be put in a dust-free environment with good ventilation but no mechanical vibration, source
of large noise and power interference.
e)Do not put the Analyzer near a brush motor, scintillant fluorescent lamp and electrical contact equipment often
used.
f)The Analyzer shall be prevented from direct sunlight exposure and not be placed near heat and wind sources.
g)The platform for its installation shall be flat and the surface shall be of hard materials, rather than carpet or
plastics foam. The platform shall be able to bear a weight of more than 75kg. (The Analyzer shall not be
disassembled into several independent parts and weight of major components are not shown)
● If the temperature and the humidity cannot meet the requirements above, an air conditioner shall be used.
However, the instrument may fail to meet all the safety requirements during drying.
● In an operating process, the Analyzer will generate heat and exhaust the heat at the back and side. The
working environment should be kept well ventilated, and a ventilating device should be used if necessary.
But the Analyzer should be protected from direct airflow; otherwise the test accuracy may be affected.
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(2)Safety requirements
a)Use inside room;
b)Height above sea level is not higher than 2000m;.
c)Ambient temperature 5℃~40℃.
d)When temperature is lower than 31℃, the maximum relative humidity is 80%; when temperature is 40℃, the
relative humidity linearity decreases 50%.
e)Power voltage fluctuation is no more than nominal voltage ±10%.
f)Transient overvoltage is facility type (overvoltage type) II.
g)Contamination level is level 2.
h)Waterproof level is IPX0.
i)Material level: Ⅲa.
2.1.3 Power requirements
(1)Supply voltage: 220/230V~ 50/60Hz
(2)Rated power: 450VA
Notes:
During normal operation, the Analyzer has power consumption smaller than the rated maximum power
consumption because:
疗
● the refrigeration and heating systems do not work continuously after the Analyzer becomes stable. As a
result, the power consumption will decrease.
● the power components of the Analyzer work at different time rather than work simultaneously.
(3)Fuse: F4AL250V 5mm×20mm
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(4)To ensure the reliable operation of the Analyzer, a 10A receptacle shall be used for the Analyzer and three 5A
receptacles shall be used for the display, host and printer.
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● The receptacle connected with the power cable shall be reliably grounded.
● The receptacle connected with power cable shall be placed near the Analyzer and easily disconnected.
● To ensure the reliable operation of the Analyzer, sharing the same receptacle with high-power electrical
appliances (such as air conditioner, refrigerator and oven) should be avoided.
迪
2.1.4 Requirements for pure water

The peak water consumption of the Analyzer is about 3L per hour. The pure water added to pure water tank shall
meet following requirements.
(1)The electric conductivity of the pure water shall be smaller than 1μs/cm.
(2)The temperature of the pure water shall be 15℃~30℃.
(3)The pure water shall be added to pure water tank slowly.
2.2 Unpacking
2.2.1 Unpacking steps
After the arrival of the Analyzer, please carefully check the package of the Analyzer. If the package is damaged,
please contact Dirui or our local agent. If the package is intact, please unpack the Analyzer by following the steps
below.
(1)Put the box in the direction pointed by the arrow.
(2)Open the box of accessories and check the objects in the box according to the packing list. In case of shortage,
please fill it in the Installation Acceptance Report and contact Dirui or our local agent.
(3)Open the host box with appropriate tools and then inspect the appearance of the Analyzer carefully, and then
check according to the packing list. In case of damages in carrying or shortage of parts, please fill it in the
Installation Acceptance Report and contact Dirui or our local agent.
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2.2.2 Removal instructions for the outer packaging of the host

The outer packaging box needs to remove the wrapping film, packing tape, carton board and buffer EPE.
Protective gloves should be worn during the removal of the outer packaging of the host to avoid scratching
your hands.
(1)Removal of the wrapping film
Remove the wrapping film from the outer box, and after removal the box is as shown below:
(2)Removal of carton 疗
Fig. 2-2-1 Analyzer host package box with winding film removed
Remove the four straps and carton surrounding boards, pads and cover, as shown below:
医
瑞
迪
Fig. 2-2-2 Analyzer host with outer packaging carton removed

(3)Removal of buffer in box
Remove the EPE cushion and EPE liner as shown:
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Fig. 2-2-3 Remove buffer EPE

Place the analyzer on the horizontal platform after removing the package.
2.2.3 Analyzer internal fixing devices removal instructions
Inside the analyzer, there are five fixing devices for the front door, waste strip box, panel, clamping jaw, and probe,
as shown in the figure:
疗
医
瑞
迪
Fig. 2-2-4 Analyzer internal fixing diagram

(1)Remove the front door fixing device
Remove the fiberglass tape (four rectangles in the figure) pasted to the front door of the analyzer as shown in
Figure 2-2-5. Be careful not to remove the logo together when removing the fiberglass tape.
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Fig. 2-2-5 Analyzer front door fixing diagram

(2)Remove the waste strip box fixing device
Open the right front door, remove the EPE buffer block in Figure 2-2-6, and close the right front door.
疗
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瑞
迪
Fig. 2-2-6 Analyzer waste strip box fixing diagram

(3)Remove the panel fixing device
Open the top cover of the analyzer and remove the EPE board in Figure 2-2-7.
Fig. 2-2-7 Analyzer panel fixing diagram

(4)Removing the clamp jaw Z-axis fixing device
Remove the clamping jaw Z-axis screw (be careful not to scratch the analyzer during the disassembly process) as
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shown below:
Fig. 2-2-8 Analyzer clamping jaw Z-axis fixing diagram

(5)Remove the clamping jaw Y-axis fixing device
Remove the clamping jaw Y-axis screw and take out the probe Y-axis fixing part (be careful not to scratch the
analyzer during the disassembly process) as shown in the figure:
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Fig. 2-2-9 Analyzer clamping jaw Y-axis fixing diagram

(6)Remove the probe Z-axis fixing device
迪
Remove the probe Z-axis screw (be careful not to scratch the instrument during the disassembly process) as
shown below:
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Fig. 2-2-10 Analyzer probe Z-axis fixing diagram

(7)Remove the probe Y-axis fixing device
Remove the probe Y-axis screw and take out the probe Y-axis fixing part (be careful not to scratch the analyzer
during the disassembly process) as shown below:
疗
医
瑞
迪
Fig. 2-2-11 Analyzer probe Y-axis fixing diagram

(8)Remove the probe clamping jaw X-axis fixing device
Loosen the screw in the circle shown in Figure 2-2-12 (Note: the screw here cannot be screwed down to prevent
the screw from falling inside the analyzer), and the rear cover plate is removed from the frame according to the
direction shown in the figure (i.e. wide arrow direction in Figure 2-2- 13). Then cut off the nylon tie in Figure
2-2-14 (Note: Do not damage the timing belt when cutting the nylon cable tie here.), cut off the nylon tie and
install the rear cover plate according to the reverse direction shown in Figure 2-2-13 and tighten the screw in the
circle shown in Figure 2-2-12. The disassembly and assembly work of the instrument is completed.
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Fig. 2-2-12 Screw loosening position
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迪
Fig. 2-2-13 Rear upper cover plate position
Fig. 2-2-14 Nylon tie position
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● Be careful not to scratch the analyzer when disassembling or installing the cover plate.
● Do not drop the screws inside the analyzer when loosening or tightening them.
2.2.4 Way of carrying
(1)Take out all reagent bottles, sample containers, detergent (Detergent Ⅰ, Detergent II) bottles and diluent bottles.
(2)Completely exhaust the liquid in syringe pump and other pipelines.
(3)The Z-axis fixing device of the probe should be replaced in reverse order according to Figure 2-2-10 before
handling to avoid damage to the probe.
(4)Keep the Analyzer vertical during carrying and transporting process.
(5)Avoid vibration during carrying, and check and adjust the Analyzer after carrying to make sure it is normal
before use.
As the Analyzer is stationery equipment, it shall not be carried during normal working process and no device
used for lifting and carrying is provided.
2.3 Installation process

2.3.1 Installation of the Analyzer
疗
(1)Put the Analyzer at an appropriate position and adjust the levelness of the Analyzer.
(2)Relieve the fixation of probe mechanism and mechanical arm mechanism.
(3)Cap the detergent bottle containing 500mL Detergent II (probe outer wall detergent) and put the bottle in the
Analyzer (please see Fig. 1-3-5 Left view of the Analyzer).
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(4)Open the upper cover of the Analyzer and put a detergent bottle containing 50mL Detergent I (probe inner wall
detergent) at the reagent position at the innermost side of the normal-temperature reagent rack.
(5)Installation of pure water tank
a)After adding 10L deionized water to the pure water tank, assemble the pure water tank assembly and put it at a
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corresponding installation position.

b)Connect the pure water pipe on pure water tank with the pure water inlet (4 in Fig. 1-3-3) connector on the back
plate of the Analyzer.
c)Plug the liquid level sensor connector on pure water tank into the pure water liquid level sensor port (5 in Fig.
迪
1-3-3) on back plate of the Analyzer.
The pure water pressure at pure water inlet < 100kPa.

(6)Installation of waste liquid tank
a)After ensuring the waste liquid tank has no waste liquid inside, put the waste liquid tank assembly at
corresponding installation position.
b)Connect the waste liquid pipe on waste liquid tank with the waste liquid outlet (3 in Fig. 1-3-3) connector on the
back plate of the Analyzer.
c)Plug the liquid level sensor connector on waste liquid tank into the waste liquid level sensor port (2 in Fig. 1-3-3)
on back plate of the Analyzer.
● The drainage system shall be in compliance with the local regulations with regard to sewage discharge and
treatment of medical institutions.
● The height difference between the waste liquid tank and the Analyzer shall be greater than 0.5m.
● The waste liquid may have chemical and biological hazards and the waste liquid discharge pressure shall
be ＜100kPa.
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2.3.2 Power connection
Before power connection, it shall be ensure the power switch of the Analyzer is at OFF position.
Insert one end of the power cable of the Analyzer into the power port (2 in Fig. 1-3-6) on the right rear plate of the
Analyzer and connect the other end with the wall receptacle.
2.3.3 Connection of peripheral equipment
(1)Install and connect the computer, display and printer and check
a)Whether the printer driver is installed.
b)The type of printing paper.
(2)Insert one end of the communication cable of the Analyzer into the network port (1 in Fig. 1-3-6) on the right rear
plate of the Analyzer and connect the other end with the network port of the computer host.
2.3.4 Software installation and uninstallation
See 3.1 Software install and uninstall for details.
2.3.5 Commissioning of the Analyzer
Conduct following operations on the system maintenance interface in the sequence below.
(1)Tubing exhaust
specific operation.
(2)Mechanical motion check
疗
Execute tubing exhaust, fill Detergent Ⅱ in tubing and exhaust the air in tubing. See “10.3.3 Tubing exhaust” for
Execute 20 mechanical motion checks to confirm whether each mechanism operates normally. See “10.3.1
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Mechanical motion check” for specific operation.
(3)Probe rinsing and maintenance
The probe has been rinsed before being delivered out of the factory. However, as the probe has very small inner
diameter, it may be blocked by dust during storage. If the liquid from the probe is discontinuous, not vertical, or
flows in strands, the probe shall be rinsed and maintained. See “10.5.1 Probe cleaning” for specific operation.
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2.3.6 Test of performance

(1)Calibration and QC
Edit QC and calibration parameters, carry out QC and calibration testing, and record the results in Installation
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Acceptance Report.
(2)Clinical item test
Edit chemical parameters, register reagent information, test clotting methods PT and FIB, calculate coefficient of
variation and fill the test results in Installation Acceptance Report.
2.3.7 Training for medical personnel
Conduct training on the operation and maintenance of the Analyzer for medical personnel and record the training in
Installation Acceptance Report.
2.3.8 Fill-in of Installation Acceptance Report
Fill in the Installation Acceptance Report completely and send one copy to Dirui or our local agent.
2.4 Accessory devices

2.4.1 Barcode reader
2.4.1.1 Scanning range of barcode reader
The barcode reader is used to identify the barcode on reagent bottles and reagent rack in reagent chamber as well as
the barcode on sample tubes and sample rack in sample chamber.
2.4.1.2 Requirements for sample container
(1)Specifications:
Test tube: Φ12mm×75mm, Φ12mm×100mm, Φ13mm×75mm, Φ13mm×100mm(±1 mm), Φ16mm×100mm (Not
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recommended. If used, please remove the clamping part from the sample rack assembly as shown below.)
Fig. 2-4-1
Standard cup: Φ14mm×37mm (±1 mm)
(2)The tube mouth shall be regular without extrusion deformation.
2.4.1.3 Requirements for use of barcodes
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(1)Barcode type: code 128, code 39, code 93, Ι2of 5, Codebar, UPC/EAN.
(2)Size of barcode label: The narrowest unit size of the barcode is ≥200μm, and the width of the barcode is
required to be ≥12mm. When cutting the barcode, the start blank and end blank shall not be smaller than 3mm, the
recommended size of effective length is ≤40mm, level C is recommended as barcode reflectance level, as shown
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in Fig. 2-4-1.
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Fig. 2-4-2
(3)See Table 2-4-1 for number of digits of different barcodes.
Table 2-4-1
Sample barcode Identified code digits

Identified characters
category (recommended)
Code39 4~10 Numbers 0~9, letters

Numbers 0~9, and the number of recognized
2of5 4~16
character codes must be even
Codabar 4~14 Numbers (0 to 9), letters (A, B, C, D)
2.4.1.4 Requirements for pasting barcode labels

(1)Barcode label shall be pasted in a flat manner without crumple and pollution and the print of barcode lines cannot
be incomplete as this may lead to incorrect reading.
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(2)Pasting of barcodes
The lower edge (excluding the start blank) of the barcode shall be 15mm~20mm from the tube bottom to ensure
correct reading of the barcode. When inserting the tube to the sample position on sample rack, it shall be ensured the
barcode faces the opening of the sample position. The pasting of sample barcodes is shown below.
Fig. 2-4-3 Pasting of sample barcodes
● The barcode shall not have characters such as ‘’, “ ” and ( ), or it cannot be normally identified.
● The reading window of the barcode reader shall be regularly cleaned.
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Chapter 3 Operation of software
3.1 Software installation and uninstallation
Software installation and uninstallation of Win7/Win10 operating system.

3.1.1 Software install
Put the application software installer disk of the Analyzer into the CD driver of the computer, open the installation
folder, right click the file “Setup.exe” and select “Operate (A) as an administrator” on the pop-up menu, select the
installation language and a window shown below will appear.
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Fig. 3-1-1
If you want to change the installation path, click the [Browse…] in the figure above to select the installation path. If
you use the default installation path, click [Next >] and a window confirming the installation will pop up, as shown
in the figure below.
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Fig. 3-1-2
Click [Install] to prepare to install the upper computer software program, as shown below:
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Fig. 3-1-3
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Fig. 3-1-4
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Click [Finish] to finish the software installation, and the icon of the software will be generated on the desktop
automatically.
3.1.2 Software uninstallation
The software can only be uninstalled when the Analyzer is not operating!
Method 1: If you want to delete an application software from current computer, enter the “Program and functions”
of control panel first. Then, select “Automatic Blood Coagulation Analyzer”, click [Uninstall/ change] and an
interface shown below will appear.
Fig. 3-1-5
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Click [Yes] and you will uninstall the software according to prompts.
Fig. 3-1-6
Click [Yes] to keep the database files used by the software. Click [No] to delete the files. Then the following
figures will be shown:
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Figure 3-1-7
Fig. 3-1-8
Method 2: Click “Start”, find out “Dirui Industrial Co., Ltd” in “All programs” and then click “Automatic Blood
Coagulation Analyzer” to uninstall the software of the Analyzer according to prompts.
Method 3: doucle-click “unins000.exe” in the installation path to finish uninstallation.
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3.2 System login

Connect power for the computer host, computer display, printer and the Analyzer (lower right rear part of the
Analyzer).
Double-click the icon of Analyzer application software (hereinafter referred to as software), or click
“Start”, find the software in the “Program” window and click it to enter the “Login” window, and the interface is as
shown below:
Fig. 3-2-1
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Fig. 3-2-2
Input the correct user name and password (the initial user name is admin and the initial password is 1), click [Login]
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or Enter to enter the main window of the software, and the interface is as shown below:
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Fig. 3-2-3
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After successful login, the interface displays Offline Status , showing that the software is not connected
with the Analyzer. You can browse the windows in the functions area and switch between users at this time.
On the “Login” interface, if a wrong user name and password are input, login failure will appear, and the interface is
as shown below:
Fig. 3-2-4
An interface shown below will appear if a wrong user name or password is input for consecutive three times and you
should click [Yes] to exit the program.
Fig. 3-2-5
(1)System online: Click 疗

The buttons on the main window of the software have functions below.
at the upper right part of the software main window to connect the Analyzer. It
will show “Standby” on the status bar if it is online. At this time, you can send a test command to the Analyzer.
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After software login, if the Analysis Part is not connected with power or the data cable is not connected and the icon
does not change after clicking , it means online failed. Under this condition, please conduct online again
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after connecting the data cable and power.

(2)Registration of the Analyzer: Click “BCA-1000” at the lower left corner of the software and an interface below
will appear.
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Fig. 3-2-6
(3)Exit system: On the software main window, click in the shortcut keys area to enter an “Exit system”
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confirmation window, as shown in the figure below.
Fig. 3-2-7
Click [Yes] on the “Exit system” window to exit the software system.
● When the testing doctor has a rest, it is recommended to exit the software to prevent nonusers destroying
the software or modifying data. Users are recommended to back up the database regularly to prevent
accidental data loss.
● After the initial user name and password are input and first-time login is finished, set the user name,
password, and user group in the “User Settings” of sub module “User Permission” in “System” for next
login.
3.3 Software interface description

3.3.1 Window composition
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Software interface is composed of status bar, functions area, working area and buttons area.
(1)Status bar: It is located at the lowermost part of the main window and displays the status of the Analyzer in real
time, as shown in the figure below.
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Fig. 3-3-1
Description of detailed functions:
: Display the model of the current instrument and version information.

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: Display the status information of the current instrument.
: Connection status of the printer. If the icon shows a red ×, it means the printer is not connected. If a blue √,
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it means the printer is normally connected.
: Communication status with LIS. If the icon shows a red ×, it means LIS is not turned on. If a blue √, it
means LIS has normal communication.
: Communication status with the Analyzer. If the icon shows a red ×, it means the Analyzer is offline or has
communication interruption. If a blue √, it means the Analyzer is normally online.
: Alarm icon. The icon shows a green exclamation mark in the status bar if there is no alarm message. If
there is an alarm message, the icon will flicker (red or yellow). By clicking the shortcut key F7 or the alarm icon, the
operator can check and set the alarm message and then handle the abnormity according to the prompts.
(2)Functions area: The operator can select the functions by clicking the functions, as shown in the figure below. The
navigation menu is a two-level menu, with lower part being the main menu and upper part being the submenu after
clicking the main menu.
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Fig. 3-3-2
(3)Working area: Enter the region for specific operation and click the relevant function button to enter the window
of the working area. If clicking “Samples” in the functions area and selecting “Register” in the submenu, an
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interface shown below will appear.

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Fig. 3-3-3
(4)Buttons (auxiliary buttons) area: It facilitates to the operation of users, as shown below:
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Fig. 3-3-4
: Instrument logo icon, clicking it can return back to the main interface.
: Buttons for operating the instrument.
: Display current date and time.
: Information of current user, clicking the man-like icon can switch between users.
: Help
: Minimize
: Exit
3.3.2 Functions of keyboard
(1)Num-lock key (NumLock) 疗
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It can be used to check whether the numeric keypad turned on.
(2)Caps-lock key (CapsLock)
It can be used to switch the input of capital and lower-case letters.
(3)Common shortcut key
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F1: System help
3.4 How to operate the software

The software functions can be selected by clicking through the mouse. In combination with the keyboard, values
and words are input (the input method depends on Windows system, it can be switched by pressing Shift+Ctrl).
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3.4.1 Cursor movement

The cursor will move once clicking an input area or item.
3.4.2 Selection of buttons
The buttons can be selected by clicking through the mouse.
3.4.3 Window opening
You can click the Windows button to open a window. The windows can be divided into modal window and
non-modal window.
Modal window: Other windows cannot be operated before this type of window is closed. If you want to close the
window, click [Close]. For example, the “Patient Info” window in “Register”, as shown in the figure below.
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Fig. 3-4-1
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Non-modal window: Other windows can still be operated before this type of window is not closed. For example, the
“Register” window in “Samples”, as shown in the figure below.
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Fig. 3-4-2
3.4.4 Operation of list box and scroll bar

(1)List box
The frame that displays part of multiple pieces of information is called a list box. The information required among
displayed contents can be found out and selected by using the list box, as shown in the figure below:
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(2)Scroll bar
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Fig. 3-4-3
The scroll bar is used to adjust the display range of contents in a list box. The scroll bar is generally divided into
vertical scroll bar (at the right corner of the list box) and transverse scroll bar (at the lower corner of the list box), as
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shown in figure above.
To check the contents displayed in a list box, you can click or drag .
(3)Operation of drop-down list box
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You can click the at the right side of the drop-down list box to open or close the list box. Using a drop-down list
box can display more information. Once a required item is selected, the selected item will be displayed at the
uppermost and the drop-down list box will disappear.
3.4.5 Radio button and check box
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Radio button: It means only one function will be selected among several functions. For example, after selecting
“Check Results” in the “Result Query” window, you can only select “Intraday” or “Results within three days” but
cannot select them both, as shown in the figure below.
Fig. 3-4-4
Check box: It means two (or above) functions can be selected simultaneously. The check boxes under in
the “Result Query” interface are shown in the figure below.
Fig. 3-4-5
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Chapter 4 System management
Click the “System” option in the functions area to enter the system management submenu as shown below:
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Fig. 4-1
4.1 Information management

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Add: After the completion of setting, click [Add] and relevant information will be displayed in the working area at
the right side.
Modify: Select the information to be modified in the working area at the right side, input the information at the left
side and then click [Modify].
Delete: Select the information to be deleted in the working area at the right side and then click [Delete].
After the completion of these setting, the information will be listed in the drop-down list box of “Patient Info” and
the sample info interface in the “Register” interface.
4.1.1 Hospital information
Click “Hospital Info” in the “Info Management” window to set the sending department, sending doctor, section and
ward, and the display is as shown below:
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Fig. 4-1-1
4.1.1.1 Sending department
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Click “Sending Dept.” to add, delete or modify the sending department name and mnemonic.
(1)Sending department: Input the sending department name in the input box.
(2)Mnemonic: Input the mnemonic of sending department in the input box. The mnemonic can help users input the
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information quickly. For example, the mnemonic of sending department can be set as wgk or in figures, like 001. In
the information input area, you can input wgk or 001 and then press Enter to input the information of the sending
department automatically, rather than input the name of the sending department.
4.1.1.2 Sending doctor
Click “Sending Doctor” to add, delete or modify the doctor name and the department, and the display is as shown
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below:
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Fig. 4-1-2
(1)Sending doctor: Input the sending doctor name in the input box.
(2)Sending department: Select the sending department from the pull-down menu.
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(3)Mnemonic: Input the mnemonic of the sending doctor in the input box. The mnemonic can help users input the
information quickly.
4.1.1.3 Section
Click the “Section” option to add, delete or modify a section, and the display is as shown below:
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Fig. 4-1-3
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(1)Section: Input the section name in the input box.
(2)Mnemonic: Input the mnemonic of the section in the input box. The mnemonic can help users input the
4.1.1.4 Ward
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Click the “Ward” option to add, delete or modify a ward, and the display is as shown below:
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Fig. 4-1-4
(1)Ward: Input the ward name in the input box.
(2)Mnemonic: Input the mnemonic of the ward in the input box. The mnemonic can help users input the information
quickly.
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4.1.2 Patient information

Click “Patient Info” in the “Info Management” window to set the registration type, nationality, sex, age, unit and
charges category.
4.1.2.1 Registration type
Click “Registration Type” to add, delete or modify a registration type, as shown in the figure below.
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Fig. 4-1-5
(1)Registration type: Input the registration type name in the input box.
(2)Mnemonic: Input the mnemonic of registration type in the input box. The mnemonic can help users input the
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4.1.2.2 Nationality
Click “Nationality” to add, delete or modify a nationality, and the display is as shown below:
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Fig. 4-1-6
(1)Nationality: Input the nationality name in the input box.
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(2)Mnemonic: Input the mnemonic of the nationality in the input box. The mnemonic can help users input the
4.1.2.3 Charges category
Click “Charges category” to add, delete or modify a charge category, as shown in the figure below.
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Fig. 4-1-7
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(1)Charge category: Input the charge category name in the input box.
(2)Mnemonic: Input the mnemonic of the charge category in the input box. The mnemonic can help users input the
4.1.3 Other information
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Click “Other Info” in the “Info Management” window to set the clinical diagnosis, item unit and remarks.
4.1.3.1 Clinical diagnosis
Click “Clinical Diagnosis” to add, delete or modify a clinical diagnosis, as shown in the figure below.
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Fig. 4-1-8
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(1)Clinical diagnosis: Input the clinical diagnosis name in the input box.
(2)Mnemonic: Input the mnemonic of the clinical diagnosis in the input box. The mnemonic can help users input the
4.1.3.2 Item units
Click “Item Units” to add, delete or modify an item unit, and the display is as shown below:
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Fig. 4-1-9
Item units: Input the item unit in the input box. After the information is added successfully, the information will be
listed in the drop-down list of “Analysis Parameters” in the “Item Parameters” interface.
4.1.3.3 Remarks
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Click the “Remark” option to add, delete or modify a remark to the report, and the display is as shown below:
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Fig. 4-1-10
(1)Remark: Input the remark name in the input box.
(2)Mnemonic: Input the mnemonic of the remark in the input box. The mnemonic can help users input the
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4.2 System log

Click the “System Logs” option in the “System” window, and the display is as shown below:
System log includes login logs and operation logs.

(1)Log type: select a log type from the drop-down list box.
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Fig. 4-2-1
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(2)Query date: After selecting the start and end date from the drop-down list box, the log information meeting the
conditions is displayed in the working area.
(3)Username: in the pull-down menu initialize the name info of users below the current user level, and you can
screen data.
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Click [Print] to print current log list.
4.3 User management

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Except from the administration permission, other users cannot see the “User Management” module.
Click the “User Management” option in the “System” window to browse user information, add a new user, modify
and delete user info, check a user group, conduct permission setting of a new user group and conduct common
function setting.
4.3.1 User management
Click “User Settings” in the “User Management” window to check, delete or modify user information and add a new
user, and the display is as shown below:
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Fig. 4-3-1
Input the user name, mnemonic, password, confirm password (the two passwords shall be the same and they are
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case sensitive), and select the permission of the operator from the pull-down menu of user group.
(1)Add user: after the above information is set, click [Add] to add a new user, and the user added is displayed in the
user list on the right.
(2)Modify user: click to select the added user to modify the information other than the user name, and click [Modify]
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after the information is modified to complete the modification to the info about the selected user.
(3)Delete user: to delete user information, click to select user information in the workspace on the right, and then
click [Delete].
4.3.2 Permission setting
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Click tag “Permission Setting” in the “User Management” window to view the user group and set permission, and
the display is as shown below:
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Fig. 4-3-2
The interface displays such 3 user groups as administration, operation and query:
(1)The administration permission is only allowed to modify the user group of operation and query; not allowed to
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modify the permission of the administration user group.

(2)The operation and query permission have no function of permission setting.
4.3.3 Common function setting
Click tag “Function Settings” in the “User Management” window to set common functions, and the display is as
shown below:
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Fig. 4-3-3
Click on the choice box in front of the “Title” bar, then click [Save], and the selected common functions are
displayed in the menu on the left side of the interface as shown below:
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Fig. 4-3-4
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Chapter 5 System Setting
Click the “Setup” option in the navigation area to enter in the system setting submenu as shown below:
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Fig. 5-1
There item maintenance setting, item parameter setting, combination setting, printing setting, communication
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setting, other information, reagent setting and software interface setting are available.
5.1 Item maintenance

Click tag “Item Maintenance” in the “Setup” window to enter in the item maintenance window, and the display is as
shown below:
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Fig. 5-1-1
(1)Item information:
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a)Category: select the coagulation item from the pull-down menu.
b)Item No.: item numbers are not allowed to be modified.
c)Abbr.: item abbreviations are not allowed to be modified.
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d)Barcode number: input the barcode number into the input box.
e)Full name: input the full name of the item in the input box; the full name can be empty and it can also be
repeated with existing information.
f)Printing Sequence: set the order of the items in the print report; the default printing order is the same as the item
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number, and it cannot be empty or repeated with existing information.

(2)Add a new item
After the information of a new item is input in the item information workspace, click [Add], and the new item
information is added to the workspace list.
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(3)Modify item information

Click to select an item from the workspace list, click [Modify] after the item information is modified (item numbers
and item abbreviations are not allowed to be modified), and the modified information is saved and displayed in the
item list.
(4)Delete item
Click to select an item from the workspace list and click [Delete] to delete the item.
(5)Print item information
Click [Print] to print all item information.
Users cannot directly add new items in the item maintenance interface. For new items to be added, please
contact customer service personnel or suppliers.
5.2 Item parameters

Click the “Item Parameters” option in the “Setup” window to enter in the item parameter setting window where the
item analysis parameters, calibration parameters and range parameters can be set.
After the parameters on each page are edited, the operator must click [Save] to save the parameters.
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5.2.1 Analysis parameters

5.2.1.1 Analytical methods
The analysis methods of the Analyzer include coagulation method, chromogenic substrate method and
immunoturbidimetric method. When the reagent is added into a sample, the crosslinked fibrin (coagulation method)
is generated in the sample, and the reagent releases the color material (chromogenic substrate method) or binding of
antigen-antibody promotes the aggregation of latex particles (immunoturbidimetric method). In this process, the
light passing through the sample gradually weakens. Based on the changes in the transmission light intensity, the
percentage detection method can be used to calculate the solidification time (solidification method), and the velocity
method can be used to calculate the amount of change in absorbance within a specified time (chromogenic substrate
method and immunoturbidimetric method).
(1)Percentage detection method:
This method is applicable to the testing of the coagulation time of the sample. When the starting reagent is just
added in the sample and the sample has not reacted with the reagent yet, the transmission light intensity of the
sample is maximized, and the light intensity is defined as 100%. As the sample starts to react with the reagent, the
transmission light intensity gradually decreases until the reaction ends and then the transmission light intensity no
longer changes. The transmission light intensity value at this time is defined as 0%. The time taken for the
transmission light intensity to reduce from 100% to 50% is defined as the sample coagulation time in the figure
below, and this method can be used to detect a sample with longer coagulation time or less reaction changes.
Notes:
According to specific test items, the solidification time can also be customized. For example, the time taken
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for light intensity to reduce from 100% to 70% can be defined as the sample solidification time.
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Fig. 5-2-1 Diagram of Percentage Detection Method

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Establish a calibration curve by solidification method:

Establish a calibration curve with the coagulation time and sample concentration (only applicable to the detection of
fibrinogen). Dilute the calibrated plasma into several concentrations (normally 5-6 concentration points, including
high, medium and low concentration levels) in proportion according to the requirements of reagent specifications,
measure the corresponding solidification time for calibrators in different concentrations according to the percentage
detection method, and draw the calibration curve as shown below.
Fig. 5-2-2 Diagram of Calibration Curve by Solidification Method
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The formula of calibration curve is T=f(C)

T - Coagulation time
C - Sample concentration
Calculate sample concentration based on the measured sample coagulation time.
(2)Velocity method:
a)Chromogenic substrate method
This method is applicable to the testing of the activity percentage of antithrombin III (AT-III) in the sample.
When the substrate reagent is added to the sample, the substrate reagent combines the remaining thrombin in the
sample and releases the color material and the absorbance of the sample gradually increases. During the
calculation, the absorbance difference dOD between time t1 and t2 is defined and then the activity percentage of
sample is calculated based on dOD in absorbance in accordance with the calibration curve shown in the diagram.
Formula of the calibration curve is Y=AX+B.
Y - dOD
A - Slope
X - Activity percentage of sample
B - Intercept
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Fig. 5-2-3
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Fig. 5-2-4
b)Immunoturbidimetric method
This method is applicable to the determination of the concentration of fibrin degradation products in the sample,
including the detection of FDP and D-Dimer. When the latex reagent is just added in the sample, the latex
particles in the latex reagent aggregate after being combined with the antigen in the sample. The sample turbidity
becomes larger and absorbance is gradually increased. During the calculation, the absorbance difference dOD
between time t1 and t2 is defined and then the sample concentration is calculated based on dOD in absorbance in
accordance with the calibration curve shown in the diagram. The calculation process is similar to the
chromogenic substrate method.
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Fig. 5-2-5
5.2.1.2 Set analysis parameters

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Fig. 5-2-6
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Click tag “Analysis Parameters” in the “Item Parameters” window to set analysis parameters, and the display is as
shown below:
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Fig. 5-2-7
(1)Set analysis parameters:
Click to select the item name to be set from the “Item List” in the workplace on the left.
a)Added sample volume: input the sample volume in the input box (unit: μL).
b)Test diluent: select the diluent abbreviation of diluted sample from the pull-down menu.
c)Retest diluent: select the diluent abbreviation of diluted sample from the pull-down menu during retest.
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d)First dilution: select the abbreviation of diluent for the first dilution from the pull-down menu.
e)Adding volume: volume of diluent added in the first dilution (unit: μL).
f)Re-dilution volume: drawn volume after the sample is diluted for the first time (unit: μL).
g)Second dilution: select the abbreviation of diluent for the second dilution from the pull-down menu.
h)Adding volume: volume of diluent added in the second dilution (unit: μL).
i)Test Methods: solidification method, immunoturbidimetric method or chromogenic substrate method are
available in the pull-down menu.
j)Test channel: i.e. test wavelength; 405, 575 and 660 are available.
k)Test Time: the test time required for testing the item under normal conditions.
l)Decimals: select decimal places from the pull-down menu, and the output result of the test item will be
displayed in the decimal places selected.
m)Item Units: the default unit of the item in the software system See “4.1.3.2 Item units” for the addition and
deletion of item unit.
n)User Unit: the unit displayed on the report when the report is printed.
o)Conversion factor: factor to be multiplied to convert the item unit into user unit.
(2)Process setting:
Click [Set Process] in the interface as shown in Fig. 5-2-7 and the display is as shown below:
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Fig. 5-2-8
There, a new reagent addition process can be added and the existing reagent addition process can be modified or
deleted.
(3)Calculation parameter setting:
Click [Calculate Parameters] in the interface as shown in Fig. 5-2-7 and the display is as shown below:
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Fig. 5-2-9
(4)Dilution setting:
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There, the calculation parameters can be set, modified or resumed.
Click [Dilution Plan] in the interface as shown in Fig. 5-2-7 and the display is as shown below:
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Fig. 5-2-10
There, the item dilution plan can be added, modified and deleted.
5.2.2 Calibration parameters
Click tag “Calibration Parameters” in the “Item Parameters” window to set the calibration concentration and
position assignment, calibration method, concentration conversion, light intensity conversion, times of repetition,
calibration interval, calibration check, and the display is as shown below:
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Fig. 5-2-11
the pull-down menu.

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(1)Calibration Points: select the number of calibration points from the pull-down menu, and the number is up to 10.
Input the concentration of corresponding calibration solution, and select the rack number and position number from
(2)Dilution Method: select manual dilution or automatic dilution from the pull-down menu.
a)When the manual dilution is selected, corresponding concentration needs to be manually input, and it is
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unnecessary to choose the dilution plan;
b)When automatic dilution is selected, it is required to select the dilution plan in the pull-down menu. The system
will automatically calculate the concentration according to the dilution plan.
(3)Calibration method: select logarithmic, linear, or polynomial method from the pull-down menu.
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(4)Times of Rerun: select the number of retests from the pull-down menu and its range shall be 2~10.
(5)Calibration Interval: input the calibration interval in the input box (unit: h)
(6)Calibration Check: click to check Fitting check and Deviation check and set relevant parameters.
5.2.3 Range parameters
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Click tag “Range Parameters” in the “Item Parameters” window to set reference range, linear range and critical
value range, and the display is as shown below:
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Fig. 5-2-12
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(1)Specific reference value: if the patient’s age and sex are different and reference range varies, specific reference
range shall be used. Click to choose “Specific Reference Value” and the display is as shown below:
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Fig. 5-2-13
If a specific reference value is selected, the operator must set the patient’s age and six when registering the
sample. Otherwise, the reference range of the test result will be displayed as the default reference value.
(2)Default reference value: the default reference value is used when the reference range is independent of the
patient’s age and sex. Click to choose “Default Reference Value”. For example, if the default reference range of PT
is 10s~12s, the display is as shown below:
Fig. 5-2-14
(3)Linear Range: refer to the reagent specifications to input the upper and lower limits of reagent linear range. If the
test result exceeds the range, there will be a corresponding color prompt in the “Result Query” interface.
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(4)Danger Value: if the item test result is below a certain value or above a value, endangering the lives of patients,
the user can set the critical value range. After the setting is complete, if the test result is below the lower limit of set
critical value or above the upper limit of the set critical value, a prompt in the corresponding “color” will be given in
the “Test Results” interface.
Range parameter setting requirements: linear range > danger range > reference range.
5.3 Combination
Click tag “Item Profile” in the “Setup” window to set the combination and the display is as shown below:
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Fig. 5-3-1
(1)Combination name: input the name of the combination to be set in the “Combination name” input box, and the
name can be letters, numbers, Chinese characters, characters, but it cannot be repeated, otherwise it cannot be saved.
(2)Add combination: select the items to be included in the combination (abbreviations of selected items are
displayed in red) in the workplace on the right, click [Add] to add the combination and the combination will be
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displayed in the list of combination names on the left. Click to select the combination name, and display colors of all
the items included in this combination will change.
(3)Modify combination: to modify a combination, select the combination item from the combination list on the left,
modify the combination item in the “Item List” on the right (combination name can be modified at the same time),
click [Modify] to save the modified result.
(4)Click “Auto Printing”, “Only samples with patient info are printed”, and “Only print the approved samples” to
automatically print the report after the sample test.
(5)Click [Save] to save the basic information of the report.
5.4 Printing setting

Click tag “Printing Settings” in the “Setup” window to set relevant printing and the display is as shown below:
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Fig. 5-4-1
(1)Click to select a print format in the list of “Current Print Format”, and then click [Edit template] to edit the
existing template information according to own needs.
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(2)Input relevant information in the input boxes of “Organization first name”, “Organization second name” and
“Report title”.
(3)To use the report endnote, click to select “Print report endnote” and input relevant information in the input boxes
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of “Report Endnote 1” and “Report Endnote 2”. If the endnote is not to be used, “Print report endnote” may not be
checked.
(4)Select the contents of the report by clicking in the “Print options list”. The contents include: prompt, reference
value, item abbreviation, test result, item full name and unit. means selected while means not selected.
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(5)Click “Auto Printing” and “Only samples with patient info are printed” to automatically print the report after the
sample test.
(6)Select the positive sign of the print result, which can be set as “arrow (↑; ↓)” or “high/ low value (H; L)” from the
pull-down menu.
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(7)Click [Save] to save the basic information of the report.
5.5 Communication setting
This setting must be done while the Analyzer is offline.

If the Analyzer is connected to other LIS systems, it is necessary to set the LIS communication. Standard TCP/ IP
internet access is used and the communication mode conforms to the HL7 2.3.1 protocol standard.
Click the “Communication” option in the “Setup” window, and the display is as shown below:
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Fig. 5-5-1
(1)LIS communication
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Enable LIS: select “Enable LIS”, it’s allowed to set the LIS communication interface, and connect correctly to
enable LIS communication function; otherwise, disable the LIS communication function.
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When the Analyzer LIS parameter setting is changed, the parameter setting only takes effect after the
software is restarted. Users can follow the prompts to select automatic restart of the software of the
Analyzer.
(2)Communication setting
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There are two communication modes: one is the network connection, namely, the analyzer achieves LIS
communication through IP address; the other is the serial port connection, namely, the analyzer connects with the
host through RS-232 serial port.
a)When “Network Connection” is selected during communication setting, following parameters need to be set
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and the display is as shown in Fig. 5-5-1:

IP Address: input the IP address of the Analyzer, and the user can set it according to the actual situation.
Port: host port number.
Timeout retry time (S): the time interval for communication timeout retry can be set.
b)When “Serial port” is selected during communication setting, following parameters need to be set and the
display is as shown in Fig. 5-5-1:
Serial port No.: select the communication serial port number, and serial port 1 is unavailable. The default
value is 2010, but the user can set it according to actual situation.
Baud rate: select the baud rate of serial port for communication and 9600 and 19200 are available for
selection.
Data Bit: select the communication data position. 5, 6, 7 and 8 are available for selection.
Stop Bit: select the communication stop position. 1, 1.5 and 2 are available for selection.
Parity Bit: select the communication verification position. N, M, E, O and S are available for selection.
Timeout retry time(S): the time interval for communication timeout retry can be set.
Timeout retry times: the number of communication timeout retries can be set.
The default values for the Analyzer communication protocol are 19200, 8, 1, N. Contact the distributor for
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specific LIS connection issue.

(3)Result setting
a)Setting of result transmission mode:
Real-time mode: selection of “Real-time Mode” means that when all the items of each sample are tested, the
sample is regarded as a unit for real-time transmission. If “Transmit QC results” is checked, real-time
transmission of QC result can be realized. Manual transmission is needed if “Transmission QC result” is not
checked;
Manual mode: selection of “Manual Mode” means that only manual batch transmission of results is available
after the test.
b)Setting of sending result options:
Recheck results preferred: selection of “Recheck results prioritized” means that when there are both test
results and recheck results, recheck results will be transmitted to LIS;
Test results preferred: selection of “Test results prioritized” means that when there are both test results and
recheck results, test results will be transmitted to LIS;
c)Setting of sending sample options:
Send all results: select “Send all results”; when sending LIS, all samples with test results are sent to LIS;
Only send results without error marks: Select “Only send results without error mark”; when sending LIS,
samples without error marks among all samples with test results are sent to LIS.
Only send audited samples: select “Only send audited samples”. When sending LIS, audited sample results
are sent to LIS.
(4)ID setting
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a)Instrument ID: refers to the identification to describe the analyzer during LIS transmission.
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b)LIS host ID: refers to the identification of LIS system communicating with the instrument.
5.6 Other information

Click “Other Info” in the “Setup” window to conduct relevant settings of the system and coagulation, click [Save] to
save the parameters and the display is as shown below:
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Fig. 5-6-1
5.6.1 System
Click tag “System” in “Other Info” interface to set the sample test and sample validity.
(1)Click the “Sample Test Setup” to set the sample test mode.
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a)Sample test mode

For “Register”, two registration ways are available:
Rack No.: during the registration, test rack number and location must be registered. The sample must be placed in
strict accordance with the registered rack number and position. This requires the sample tube must strictly
correspond to the rack number. Samples 1 to 10 are placed on rack 1; samples 11 to 20 are placed on rack 2 and so
on. In this way, the conventional sample rack can be arbitrarily placed in the sample chamber, and the rack
number can be reused.
Sample Barcode: in this mode, sample bar code must be used for sample to be tested, and the mode is applicable
to two-way LIS communication. It can achieve fully automatic tests, meaning any sample information not
registered in the Analyzer are applied to the Analyzer terminal from LIS terminal through sample bar code.
Select sample test mode by clicking and “ ” means selected while “ ” means not selected.
● When the sample test mode is switched, if the sample is registered on the same day, click [Save] and the
following prompt is given:
Click [Yes] to complete the switching of sample test modes.
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● When the Analyzer is used for test, if no special requirements are provided, users are recommended not to
change the sample test mode of the day.
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b)Sample automatic audit
“Audit the sample(s) whose result is normal only” or “Audit the sample(s) with patient information only” can be
checked. After the selection, the Analyzer can automatically audit all the samples meeting the requirements.
c)Sample validity setting
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Sample validity is calculated from the time when the sample is registered and once it is expired, corresponding
sample is prompted in the “Register” interface.
(2)Click tag “Operate” to execute operation like reset to defaults, online settings, buzzer settings, reagent barcode
scan settings, and backup recovery settings, and the display is as shown below:
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Fig. 5-6-2
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After the setting, click [Save] to save the parameters.

(3)Click tag “Sending limit & QC Setting” to do related settings of sending limit and QC, set QC and the display is
as shown below:
a)Sending limit
Fig. 5-6-3
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Insufficient
Sending prohibited: after “Do not send” is selected, if an alarm of insufficient residual reagent is given for a
certain item, it is forbidden to send the item for testing;
Sending allowed: after “Allow to send” is selected, if an alarm of insufficient residual reagent is given for a
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certain item, it is allowed to send the item for testing.

Expired Reagent
Sending prohibited: after “Do not send” is selected, if the reagent of a certain item is expired, it is forbidden to
send the item for testing;
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Sending allowed: after “Allow to send” is selected, if the reagent of a certain item is expired, it is allowed to
send the item for testing.
Calibration liquid expired
Sending prohibited: after “Do not send” is selected, if the calibration liquid of a certain item is expired, it is
forbidden to send the item for testing;
Sending allowed: after “Allow to send” is selected, if the calibration liquid of a certain item is expired, it is
allowed to send the item for testing.
The calibration interval is reached
Yes: after “Do not send” is selected, if the calibration interval for a certain item is reached, it is forbidden to
send the item for testing;
No: after “Allow to send” is selected, if the calibration interval for a certain item is reached, it is allowed to
send the item for testing.
b)QC setting
Check “Auto accumulation” and after QC testing, daily QC results will be automatically accumulated to
monthly QC results.
(4)Shortcut
Click the “Shortcut” tab to decide whether to enable the related settings of shortcut, as shown below:
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Fig. 5-6-4
and the shortcut corresponding to the function is enabled.

5.6.2 Coagulation
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Click to tick the “Enable” column of shortcut, the right of the screen prompts ,
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Click to select tag “Coagulation” in “Other Info” window to set residual reagent alarm and the display is as shown
below:
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Fig. 5-6-5
Input the residual amount of reagent in the input box for the alarm that the reagent is insufficient.
5.7 Reagent setting

Click the “Reagent” option in the “Setup” window, and the display is as shown below:
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Fig. 5-7-1
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Select the reagent category from the pull-down menu in the “Reagent Info” workplace, input the reagent number,
reagent abbreviation, bar code number, reagent full name and printing order in the input boxes.
Add reagent: after the information of new reagent is edited, click [Add] to add new reagent. The information of
reagent newly added is displayed in the workplace list.
Modify reagent: select the reagent in the workspace list, and click [Modify] after the reagent information is modified
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(reagent type, reagent number, and reagent abbreviation are not allowed to be modified) to save the modified
information.
Delete reagent: select the reagent in the workspace list and click [Delete] according to the prompt to delete the
reagent information.
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Print: click [Print] to print all reagent information.
5.8 Software interface setting

Click the “Software Interface” option in the “Setup” window, and the display is as shown below:
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Fig. 5-8-1
There, the font size, date format, and language used for the software interface can be set.
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Modification of date format setting becomes valid after restarting the software.
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Chapter 6 Calibration Information
Click the “Calibration” option in the navigation area to enter in the calibration management submenu as shown
below:
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Fig. 6-1
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There, the calibration information can be registered and calibration results can be checked.
6.1 Calibration registration

Click the “Calibration Registration” option in the “Calibration” window, and the display is as shown below:
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Fig. 6-1-1
6.1.1 Manual registration of calibration solution
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Click [Manual Registration] in the “Calibration Registration” interface to manually register the calibration
information and the figure below will be displayed:
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Fig. 6-1-2
After the setting, click [Save and exit] to close the current page and return to the calibration registration interface as
shown below:
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Fig. 6-1-3
“Execute” and set it as “

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Calibration item successfully registered is executed by default, i.e. “
” to send the calibration test of a certain item.

”. Click the box in the row of
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6.1.2 Modify calibration parameters
To modify the registered calibration information, select the calibration solution to be modified in the “Calibration
Registration” interface, and then click [Modify] at the lower right corner to open the calibration information
modification interface as shown below:
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Fig. 6-1-4
After the calibration information is modified, click [Save] at the lower right corner to modify calibration solution
information.
For the modification of calibration information, only the item rack and position information can be
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modified.
6.1.3 Delete calibration item
Click [Delete] at lower right corner of the “Calibration Registration” interface and the calibration deletion interface
as shown below will pop up:
Fig. 6-1-5
Select the deletion conditions and then click [OK], and the information meeting the conditions is deleted.
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The registered calibration solution items can be deleted one by one, or register again.
6.1.4 Calibration test
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After calibration registration, confirm whether the reagent is placed, whether the residual reagent is sufficient,
whether the execute box is checked, place the calibration solution on the corresponding sample rack, click
and select “Calibration” in the “Send test” window as shown below:

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Fig. 6-1-6
Click [Test] to start calibration test.
6.2 Calibration result

Click the “Calibration Results” option in the “Calibration” window, and the display is as shown below:
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Fig. 6-2-1
according to the alarm info and related prompt.

(1)Calibration result query
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If the calibration failed, check whether the input parameters and used calibrator and reagent are correct, or operate
Click [Results Query] in the calibration result interface and the calibration result query window as shown below will
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pop up:
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Fig. 6-2-2
Results can be individually searched according to the calibration time or field, or jointly searched according to the
calibration time and field. Click [OK] after the query conditions are set, and all the records meeting the conditions
will be displayed on the calibration result interface.
If the calibration fails, check if the input parameters, calibrator used and reagents are correct, or operate according to
the alarm message and relevant prompts.
(2)View calibration results
Select a calibration result record from the calibration result interface, click [Detailed Info], and a detailed calibration
information window as shown below will pop up:
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Fig. 6-2-3
Click [Reaction Curve] to view the reaction curve of the calibration results as shown below:
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Fig. 6-2-4
(3)Delete calibration results
Select a calibration result record in the calibration result interface, click [Delete], and a confirmation prompt as
shown below will pop up:
Fig. 6-2-5
Click [Yes] and the selected information is deleted.
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Chapter 7 QC Management
Laboratory quality control is designed to ensure the reliability of the measured result for each sample. The reliability
of measured results covers two aspects: one is the precision, i.e. repeatability of measured results and little change in
the results measured daily in laboratory (QC is mainly used to eliminate or reduce the impact caused by random
error); the other is accuracy, i.e. correctness of measured results and their approach to the true value (QC is mainly
used to eliminate or reduce the impact caused by system error).
Random error: the difference between the measured result and the mean of measured results obtained by infinitely
many measurements of the same measured item under repetitive conditions is called random error.
System error: under repetitive conditions, the difference between the mean of measured results obtained by
infinitely many measurements of the same measured item and the true value of measured item is called system error.
It is an error component of measured results expected not to be zero.
Accuracy: it is a combination of system error and random error of the measured results, indicating the consistent
degree between the measured results and true values.
Precision: it indicates the size random error of measured results. Precision refers to the degree of compliance
between the measured results when multiple measurements are made under certain conditions.
L-J (Levey Jennings) QC chart: QC chart is a chart with QC limits. QC limit is determined by the mean ( X ) and
standard deviation (SD) obtained by repeated measurements of the known specimen (usually control material) by
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the controlled analysis method. X  2SD is the alarm limit while X  3SD is out-of-control limit.
Click the “QC” option in the navigation area to enter into QC management submenu as shown below:
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Fig.7-1
Setting of QC rules, registration of QC items, view of daily QC data and QC chart, and view of monthly QC data and
QC chart can be realized.
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7.1 QC rules
Conduct out-of-control analysis for the measured QC results according to the multi-rule judgment benchmark of
Westgard. The figure below is the multi-rule logic diagram of Westgard:
Fig. 7-1-1 Multi-rule Logic Diagram of Westgard

Description of judgment benchmark:
1-2S: One QC result exceeds X ±2SD, only used as a warning rule, and other rules are started to test QC data.
1-2.5S: One QC result exceeds X ±2.5SD, judged to be out of control, and the rule is mainly sensitive to random
error.
1-3S: One QC result exceeds X ±3SD, judged to be out of control, and the rule is mainly sensitive to random
error.
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1-NS: One QC result exceeds X ±N×SD, where N represents an inputable sample box, and the input requires a
number greater than 0 and less than 10 and only one decimal place after the decimal point.
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(2) Multi-point rule:
2-2S: 2 consecutive QC results simultaneously exceed X +2SD or X -2SD, judged to be out of control, and the
rule is sensitive to system error.
2/3-2S: among 3 consecutive QC results 2 simultaneously exceed X +2SD or X -2SD, judged to be out of
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control.
R-4S: One QC result exceeds X +2SD, the other exceeds X -2SD, judged to be out of control, and the rule is
sensitive to random error.
3-1S: 3 consecutive QC results exceed X +1SD or X -1SD, judged to be out of control, and the rule is sensitive
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to system error.
4-1S: 4 consecutive QC results simultaneously exceed X +1SD or X -1SD, judged to be out of control, and the
rule is sensitive to system error.
7T: 7 consecutive quality control results show an upward or downward trend.
10 X : 10 consecutive quality control results fall on the same side of X , judged to be out of control, and the rule is
sensitive to system error.
12 X : 12 consecutive quality control results fall on the same side of X , judged to be out of control, and the rule is
sensitive to system error.
N X : N consecutive quality control results fall on the same side of X , where N represents an inputable sample
box and the input requires an integer greater than 0 and less than 30.
Click the “QC Rules” in the “QC” window, and the display is as shown below:
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Fig. 7-1-2
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Click the selected item (the abbreviation of selected item is shown as red) from the item list on the left. Select the
appropriate option from the pull-down menu of single-point rule and multi-point rule. Click [Save] to save the
settings.
7.2 QC registration
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Click the “QC Registration” option in the “QC” window, and the display is as shown below:
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Fig. 7-2-1
QC item manual registration, information view and QC registration deletion can be realized in the QC registration
window. QC rules shall be set before QC registration is made.
7.2.1 Manual registration of control material
Manually register the control material information to use a third party’s control material to conduct quality control,
click [Manual Registration] and the display is as shown below:
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Fig. 7-2-2
Input the name and batch number of the QC products in the input box, input or select the expiration date, select the
sample type, QC level, rack and position in the pull-down menu, select the QC item in the item list on the left, input
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corresponding target value, standard deviation, QC interval and reagent batch number of QC items, click [Save] to
save the settings. Click [Save and exit] to save settings and exit from the current interface.
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● When a third party’s QC is used, the software will no longer verify the validity of the information. Please
ensure the correctness of the input data to avoid drawing wrong QC conclusion.
● After the QC item is registered, before a certain QC item is tested, items to be applied with QC test shall be
confirmed, i.e. selecting choice box “ ” in “Execute” line (newly registered QC defaults to ticked execution
mode), such as:
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7.2.2 Delete QC item

Click [Delete] and a dialog box as shown below will pop up:
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Fig. 7-2-3
Click to select the deletion conditions, click [OK], and then the information meeting the selected conditions are
deleted; click [Cancel] to exit the interface, and the information is not deleted.
7.2.3 QC test
After QC registration, confirm whether the reagent is placed and whether the residual reagent is sufficient, whether
the execution box is ticked, place the QC solution at corresponding QC registration position, click , select
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“QC” from the “Send test” window and the display is as shown below:
Fig. 7-2-4
Click [Test] to start QC test.
7.3 Daily QC
variation coefficient and other data.

N
X
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After QC test, the Analyzer automatically calculates the measured QC target value (mean), standard deviation,
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i
X i 1
Target value: N
Standard deviation:
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Variation coefficient:
Where:
N is the number of measurements,
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Xi is the test result.

7.3.1 Daily QC data
Click the “Daily QC” in the “QC” window, select tag “Data” in the window popping up and the display is as shown
below:
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Fig. 7-3-1
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QC information displayed on the interface can be viewed in the order of QC product name, QC product batch
number, item abbreviation, sample type, target value, standard deviation and result state. QC results can be
transmitted to LIS system after LIS system is enabled.
If QC is out of control, check if the input parameters, QC products used and reagents are correct, or operate
according to the alarm message and relevant prompts.
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Click [Print] to print QC results of the day and the display is as shown below:
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Fig. 7-3-2
7.3.2 QC chart for daily QC

Select tag “QC Diagram” in the “Daily QC” window, screen and view real-time QC according to the test date and
name of QC product and the display is as shown below:
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Fig. 7-3-3
(1)Select real-time QC batch number
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After QC is screened by test date, item type and QC product name, all QC items that meet the conditions will be
displayed in the item list on the left. After items are selected, the QC test results of all QC batches of selected items
will be displayed in the list on the upper right. By default, the software can only draw the real-time QC chart for at
most 2 batch numbers (2 front most batch numbers in the line after screening by conditions) under the same QC
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name, and the QC results must be paired. If the results do not come out in pairs, a real-time QC chart will not be
independently drawn for a single QC result. To change the QC solution batch number of real-time QC chart drawn,
select “Not draw” under the “Drawing” field for unnecessary batch numbers and select a method for necessary
numbers to start drawing.
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(2)View QC points of real-time QC chart

After the QC batch number is selected, the corresponding QC chart will be displayed at the bottom of the interface.
Corresponding QC batch number and results coming out in pairs will be displayed on the right side of the QC chart.
To check the data points of the paired results, move the mouse to corresponding data point and the information of
current data point will be displayed (data point batch number 1: QC result, batch number 2: QC result).
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(3)Print QC chart
To print QC chart, click [Print] and the QC chart print preview interface as shown below will pop up:
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Fig. 7-3-4
Click in the preview interface to complete QC chart printing.
7.4 Monthly QC
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In the monthly QC module, the monthly QC data can be viewed according to the conditions and the QC data can be
added, deleted and printed; QC chart can be viewed and printed.
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7.4.1 Monthly QC data
Click “Monthly QC” in the “QC” window, and by default, the monthly QC data will be displayed as shown below:
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Fig. 7-4-1
The default display of the software is the QC data of a month as of the current system date. The user can screen the
QC data to be viewed according to the test date range and QC product name, and the records meeting the conditions
are displayed in the list.
Click [Print] to preview screened QC records and the display is as shown below:
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Fig. 7-4-2
To print a report, connect the printer and click

7.4.2 QC chart for monthly QC
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on the top left corner of the interface.
Click tag “QC Diagram” in the “Monthly QC” window, and the display is as shown below:
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Fig. 7-4-3
Click [Print] to preview the QC chart for selected QC name and batch number and the display is as shown below:
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Fig. 7-4-4
To print a report, connect the printer and click on the top left corner of the preview interface.
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Chapter 8 Operation of the Analyzer
8.1 Operation description

See Table 8-1-1 for simple operation sequence of the Analyzer and chapter “8.2 Detailed operation” for specific
operation.
Table 8-1-1 Simple Operation Sequence of the Analyzer
Reference
Operation steps: Window/ button Operation
Index
1. Pre-test check - Conduct pre-test check before power is supplied 8.2.1
2. Power-on Switch on the power supply of the Analyzer

Login software System login Input the username and password in the software 8.2.2
system login window.
3. Confirm the state of the Analyzer
(1)Confirm the alarm Alarm message Refer to “Chapter 11 Analyzer Alarm and Disposal”
(2)Confirm maintenance prompt System Execute maintenance operation according to the
8.2.3
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message maintenance prompt
(3)Confirm the temperature at Status bar Confirm if the temperature at incubation position and
incubation position and test position test position is (37.0±1.0)°C
4. Confirm the analysis condition
(1)Confirm the item analysis System setting Item maintenance and reagent settings
condition System setting Item parameters
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8.2.4
(2)Set and confirm analysis System setting Combination
parameters
(3)Set item combination
5. Preparation of reagent
(1)Register reagent Reagents Reagent registration and reagent information
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(2)Reagent recharge Reagents Recharge reagent 8.2.5

(3)Confirm the residual reagent Reagents Confirm the residual reagent volume of all items and
residual test number
6. Registration and test of calibration Calibration Confirm the name of item to be calibrated
item and QC item registration Confirm the name of item to be applied with QC test 8.2.6
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QC registration
7. Sample registration Sample registration Register individual or batch conventional sample,
register individual emergency sample, edit patient 8.2.7
information, modify and delete information
8. Start test
(1)Prepare sample, calibration Place the sample, calibration solution and control
solution and control material Test material at corresponding positions 8.2.8
(2)Send test command Execute “Test” for analysis
9. During the test

(1)Monitor system System monitoring Real-time monitoring of Analyzer test state
(2)Sample dispensing suspension Sample dispensing
and continuing/Reagent dispensing suspension and
suspension and continuing continuing/Reagent Edit samples during the test and click to start test
8.2.9
(3)Stop dispensing
(4)Sample dispensing suspension and
continuing
Stop
Sample registration
Inquire, modify, delete, review and print test results
10.Confirm test results Test results 8.2.10
Check sample reaction curve
11.Review samples Item review Set review conditions and send review test command 8.2.11
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Reference
Operation steps: Window/ button Operation
Index
12. End analysis

(1)Reconfirm results Test results Confirm, verify and print review results
(2)Cut off power supply System setting Cut off power supply of the Analyzer, computer and 8.2.12
(3)Prepare before next work water purifier
Arrange and clean the Analyzer for next time use
8.2 Detailed operation

8.2.1 Check before test
Conduct following checks before test:
(1)Check if the power supply is powered on.
(2)Check the communication line and power cable among the Analyzer, computer and printer and ensure the
connection is correct and free of looseness.
(3)Check if there are sufficient print papers and place the printer papers if they are insufficient.
(4)Check if there is water attached in front of the probe and if it is dirt or bent.
(5)Check if there is sufficient detergent (Detergent Ⅰ, Detergent II) and pure water. Refer to “10.1.3 Detergent” for
detailed introduction of detergent.
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(6)Check if the waste liquid tank is drained. If the Analyzer waste liquid device is directly connected to the drainage
system, such operation is unnecessary.
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See 10.5.14 Waste treatment for disposal of waste liquid.
(7)Check if there are foams in syringe pump (liquid leakage or foams will lead to inaccuracy of data).
Deem Detergent Ⅰ, Detergent II as a corrosive liquid. Rinse with plenty of water in case of exposure to skin
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or eyes.
8.2.2 Connect power cable and log in the software
(1)Connect the Analyzer power supply. The switch at the lower right part of analysis division is power supply and
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the switch shall be normally opened when there are reagents in reagent chamber to ensure continuous operation of
cooling system.
(2)Log in the Analyzer application software and execute online command first to carry out a test.
8.2.3 Confirm the state of the Analyzer
8.2.3.1 Confirm the alarm
(1)Text display of alarm information
In case of alarm information, click alarm prompt icon or press “F7”, confirm if there is sample dispensing
stop level or stop level alarm, refer to alarm information solution to deal with the problem. Contact the customer
service staff if the fault cannot be removed.
In case of an alarm at the Analyzer, alarm code, level, contents and time will be displayed. The interface is as shown
below:
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Fig. 8-2-1
cannot be eliminated, please contact customer service staff.

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To view details of alarm record, click the information bar through mouse, and the solution and trouble reason of the
alarm will be displayed in the text box below. The user shall refer to solutions to handle problems and if the fault
If only alarm information of the day is displayed in the alarm information window, click [Alarm History] to check
historical alarm information and the display is as shown below:
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Fig. 8-2-2
In the “Alarm History” interface, alarm information can be viewed according to alarm start date, alarm end date and
alarm level and the number of alarms can be filtered and counted according to the alarm code. Click [Close] to exit
the “Alarm History” window.
(2)Alarm setting
Click [Alarm Setting] in the “Alarm info” interface and the display is as shown below:
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Fig. 8-2-3
Input the alarm code to be searched in the input box of “Alarm No.” and click [Find]. Or find by alarm level. If you
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want to go back to the initial interface after the enable and find operation. Or click [Reset].
All alarm information in the window will be displayed by default. If a certain alarm is not expected to be displayed
in the alarm information interface, you can select not to enable; can set in the enable setting interface.
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If not enable alarm is selected in the alarm setting—enable setting interface, the alarm will not be displayed
in the alarm information interface and the alarm icon will not flicker for prompt, but the alarm information
can be checked in the “Alarm History”.
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(3)View alarm statistical information

Click [Alarm Stats] in the “Alarm info” interface and the display is as shown below:
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Fig. 8-2-4
The user can check the frequency of each alarm code in all alarms in the alarm statistics interface to duly discover
the problem, reduce unnecessary alarms and ensure the test speed.
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(4)Delete alarm information

Click [Refresh] to display the alarm information under the current state.
Click [Delete All] and all alarm records displayed in the alarm list of the “Alarm info” window are deleted. Click
alarm information to be deleted with the mouse and then click [Delete] and the currently selected record consistent
with the alarm code will be deleted. All deleted alarm information can be viewed in the alarm history.
8.2.3.2 Confirm maintenance prompt message
Click [Need Maintenance] in the “Machine Maintenance” interface of the “Maintenance” window to confirm the
maintenance information. During system maintenance, refer to relevant sections of “Chapter 10 System
maintenance” for operation steps.
The “Need maintenance” displays maintenance category, item, date and personnel of the maintenance alarm will be
displayed; if currently no maintenance prompt is given, information will not be displayed. The interface is as shown
below:
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Fig. 8-2-5
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After power on each day, tubing exhaust needs executing 2~3 times, analyzer resetting needs about 2
minutes and the temperature in the incubation area and test area is stabilized at (37.0±1.0) ℃ for about
30min. Therefore, before the Analyzer enters in the standby state after startup, browse of window
information, input of item parameters and view of alarm information can be realized and the sample test can
only be carried out after the temperature in the incubation area and test area is stabilized at (37.0±1.0) ℃.
8.2.4 Confirm analysis conditions
Before the test, add analysis item and set reagent first, and then set item parameters (include analysis parameter,
calibration parameter and range parameter).
Refer to the specification or consult relevant manufacturer or retailer for parameter setting, usage, precaution and
preservation of reagent, standard solution and control material used for analysis.
(1)Add item
Before parameters are set, add an item first and conduct item maintenance (add items which are not factory
configuration). Click “Item Maintenance” in the “Setup” window to add, modify or delete coagulation item in the
item maintenance window and see “5.1 Item maintenance” for specific operation.
(2)Set reagent
Before the parameters are set, add the reagents first (add reagents which are not factory configuration). Click
“Reagent” in the “Setup” window to add, modify or delete a reagent in the reagent setting window. See “5.7 Reagent
setting” for specific operation.
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(3)Confirm item parameters

Item parameters visible to the user are defined before delivery. Where:
a)The user can set the number of decimal places, user unit, item unit, unit conversion coefficient, sample internal
dilution, process setting, test method, test channel, test time in analysis parameters according to actual needs.
b)In calibration parameters, there is factory default for calibration method, concentration conversion, time
conversion, calibration repetition times, and calibration interval, which can be modified by the user as per
needs.
c)The user can set range parameters according to actual needs.
Refer to “5.2 Item parameters” for specific operations of item parameter setting.
(4)Set item combination
Item combination is to combine relevant items. To conduct coagulation 4 items and coagulation 7 items, click the
combination name to register several items. This helps rapid input of sample registration.
Click “Item Profile” in the “Setup” window to set the combination. Refer to “5.3 Combination” for specific
operation.
8.2.5 Prepare reagent
Please use matching reagents produced by Dirui. The Company will not be responsible for inaccurate test
results caused by failure to use matching reagents.
8.2.5.1 Reagent registration
(1)Reagent use and precautions
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a)Loading, use and storage of reagents shall be in strict accordance with the requirements of reagent specification
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to avoid foaming. As the reagent contains surface active agent, violent vibration will lead to foams. During the
test, the probe’s contact with foams is mis-deemed as contact with the reagent, which will lead to inaccurate
intake of the reagent, affecting the test results.
b)Considering the surface tension, please check whether a film of liquid exists at the mouth of or inside the
reagent bottle as you open the reagent bottle cap before loading the reagent. The film of liquid will lead to
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inaccurate analytical results. Use a micropipette tip to pierce it before use.

c)Reagents from different manufacturers, in different batches or different bottles of the same batch cannot be
mixed.
Dispensing of reagents from different manufacturers, different batches but the same manufacturer or different
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bottles of the same batch in a reagent will cause changes in reagent ingredients or stability, resulting in inaccurate
test results.
(2)Reagent recharge
Click the “Reagents” option in the Function area, as shown below:
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Fig. 8-2-6
In the “Reagents” window click the “Reagent Registration” option, and the interface is as shown below:
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Fig. 8-2-7
In the “Reagent Registration” window click [Reagent Recharge], and the interface is as shown below:
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Fig. 8-2-7(a)
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Connect the card reader to the host computer via the data cable, insert the reagent card into the card reader or
place it on the surface of the card reader. Enter the barcode, click [Recharge], and the “Recharge Record” list
displays the reagent name, batch number, bottle size, and remaining amount. Click to select any of the “Recharge
Record” list, and the detailed information is displayed in the reagent information on the right.
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If you click [Recharge] and failure is prompted, you can restart the software and recharge again.
(3)Scan reagent information for registration
When the analyzer is not using the reagent rack, open the reagent chamber door and pull out the reagent rack.
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The reagent bottle is placed on the reagent rack and the reagent rack is pushed into the reagent chamber. The
Analyzer scans the information of reagents on the reagent rack. After the scanning, the scanned reagent information
is displayed in the reagent information list.
When the bar code is scanned for registration, ensure that the Analyzer is online and under standby state.
(4)Manual registration of reagent information (in standby or offline mode)
Select or input a rack number, position, reagent name, bottle specification, residual volume, date of manufacture,
validity, open-bottle date, open-bottle life, batch number and other information in the “Manual Registration” area,
click [Save] to complete manual registration of reagent information and the display is as shown below:
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Fig. 8-2-8
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(5)Print reagent information
Click [Print] and the rack number, position, reagent name, lot number, bottle size, remaining amount, expiration
date, and open-bottle expiration date are displayed in “Reagent info table”. The interface is as shown below:
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Fig. 8-2-9
Description:
a)Expiry date is the date displayed on the reagent kit package;
b)Open-bottle life is calculated from open-bottle date and open-bottle life;
Click “ ” to print the current list and click “ ” to return to the reagent registration menu.
(6)Remaining volume scan
After placing a reagent, click [Volume Scan] in the “Reagent Registration” window; the analyzer performs scan of
remaining reagent volume. The scanned remaining reagent volume is displayed on the list of the “Reagent
Registration” interface.
Only in the standby mode can you execute “Volume Scan”.
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8.2.5.2 Reagent consumption statistics

Click “Reagent Stats” in the “Reagents” window and the display is as shown below:
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Fig. 8-2-10
Select a query date range, and click [Stats] to do statistics for total reagent consumption and daily average
consumption of all test items according to the date.
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The daily average consumption is equal to the total consumption within the statistical period divided by the
actual number of days when the reagent is consumed.
8.2.6 Registration of calibration item and QC item
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(1)Registration of calibration item

a)Calibration registration: click “Calibration Registration” in the “Calibration” window and use manual
registration to complete calibration registration and setting, and then the calibration information will be displayed
in the calibration registration list area.
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b)Click to check the item to be calibrated in the “Execute” bar, and means selected while means not
selected.
c)Delete calibration: to delete a registered calibration item, click [Delete] and select the deletion mode in the
window popping up to delete the calibration information.
Refer to “6.1 Calibration registration” for details of registration of calibration items.
After changing a reagent batch number, it’s suggested to execute calibration once.
(2)Register of QC item
Click “QC Registration” in the “QC” window and complete QC registration and setting by manual mode, then the
QC information will be displayed on the QC registration list area.
Refer to “7.2 QC registration” for details of registration of QC items.
8.2.7 Register of sample
When registering in sample barcode mode, please push the sample rack smoothly. Pushing the sample rack
too quickly may cause sample spill, contamination of the sample and failure of barcode scanning.
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For sample registration through scanning a barcode, the operator shall put samples into the sample rack, and then the
scanning device will work when the rack enters into sample chamber and feed back the barcode information to the
upper computer for registration (It is recommended that the sample rack be used from left to right. When the
sample scan fails and the sample code shows “??”, please re-confirm whether the sample barcode is dirty or
placed incorrectly, delete the sample of the sample rack, and push it smoothly). For manual registration of samples,
the operator shall fill in data of samples on the sample registration interface for sample management, select test
items, and click “Register”.
8.2.7.1 Register of single sample
Click “Register” in the “Samples” window, and the display is as shown below.
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Fig. 8-2-11
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(1)Sample number and barcode number

a)Sample No.: input sample number in the relating input box. There is only one sample number on a very day.
Sample number can be select by clicking [Previous] and [Next].
b)Barcode: the barcode on the out wall of a tube containing samples. For use of barcode scanning function, the
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related barcode will be shown in the input box of “barcode number”; if the barcode scanning function is not to be
used or when the barcode data cannot be worked out, the operator can input an effective barcode in the input box
of “barcode number”. The input box of “barcode number” with “??” means that no effective data of a barcode is
obtained during scanning the sample barcode. The barcode is ranged 1~20 bits.
(2)Test Type: select Routine or STAT from the radio buttons.
(3)Rack number and position
Select sample rack number from the pull-down menu of “Rack No.” within 1~4; and select position number from
the pull-down menu of “Position” within 1~10.
(4)Type of sample and cuvette
a)Sample Type: select the sample type for test from the pull-down menu.
b)Cup type: select the cup type for test from the pull-down menu. The available kinds of cups include standard
cup and tube.
(5)Times of Rerun: input the rerun times of the same sample in the input box. The default is 1 time, and maximum is
100 times.
(6)Selection of test items: click the selected item and the color will change as shown in the figure below.
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Fig. 8-2-12
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(7)Dilution: decide whether to have analysis after dilution of sample, manually dilute and then input a dilution ratio,
or select automatic dilution, and then the Analyzer will conduct dilution during sample test.
If to use Auto-dilute function, set the dilution scheme in “Dilution Plan” on the “Analysis Parameters” interface.
Select the sample on the “Register” interface and click “Dilution Setup” behind Auto-dilute, then the detailed item
information will pop up as shown in the figure below. Click [OK] after selecting the dilution scheme, and then the
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background color of completed items will change.
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Fig. 8-2-13
(8)Combination: click to select the completed profiles. Refer to “5.3 Combination” for details of Combination
setting.
(9)Other information
Select or input a sending department, sampling time, sending time, clinical diagnosis and remarks in the pull-down
menu.
Refer to “4.1 Information management” for the details for setting the data.
(10)Edit is over, then click [Register] to save the data. The registered information will be displayed on the browsing
area at right side. Click the information bar in the browsing area to view the data of registered samples.
(11)Notes to other buttons
a)[Previous]: during sample registration, click this button to shift the sample with its number minus by one.
b)[Next]: during sample registration, click this button to shift the sample with its number plus by one.
c)[Patient Info]: for samples with patient info, either patient information or sample information can be registered
firstly.
d)[Samples List]: the sample registration condition will be displayed right after the registration is over as in the
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figure below, and the user can print or export the information in the sheet.
Fig. 8-2-14
e)Color setting: the user can change the color of items and samples on the sample registration window randomly
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by right-clicking the “Color Settings” option on the right view area, and then the window will be displayed as the
figure below.
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Fig. 8-2-15
Select color from the pull-down menu, then click [Save] to save the setting. Click [Restore Default] to restore the
default color setting of the system. The colors of options are allowed to be repeated.
8.2.7.2 Batch sample registration
For registration of many samples to the same test items, the batch registration function can be used where the
position of samples shall postpone as per the current positions.
Barcode mode does not allow batch registration.

First set the sample numbers for batch registration (start sample number), test type, sample type, cuvette type and
test sample information (either single item or profile can be selected, and dilution information of items shall be set)
on the “Register” window, then click [Batch registration] to enter the batch registration window as shown in the
figure below.
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Fig. 8-2-16
(1)Select “Batch Registration Number”: set “Sample number” as the start sample number in the main window for
sample registration, and input number of samples to be tested in the input box.
(2)Select “End Sample Number”: set “Sample number” as the start sample number in the main window for sample
registration, and input end sample number in the input box, and the end sample number shall be greater than or equal
to the start sample number.
(3)After batch edit is over, click the [Register] button. If the samples of batch registration repeat a sample of single
registration, the Analyzer will prompts that the batch registration failed.
[Register].
8.2.7.3 Register of patient information
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(4)Click [Close] and exit the window, however, the batch registration will not be performed without clicking
Click [Patient Info] in the “Register” window and the system will shift to the patient information input interface as
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shown in the figure below.
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Fig. 8-2-17
(1)Select the sample number by clicking [Previous] and [Next].
(2)Select or input the patient name, sex, nationality, age, unit, registration type, charges category, case number,
section, ward and bed from the pull-down menus. Use mnemonic for registration, and click [Save] after inputting
information.
● Patient name is necessary for editing patient information; otherwise the registration cannot proceed.
● The default doctor is the current operator. Without sending the test sample, the test time defaults to blank;
with sending the test sample, the test time defaults to that of sending the test (Y/M/D h: m: s).
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8.2.7.4 Application of LIS data

If LIS communication function is open, click [Manual LIS Application], input sample number, and click
[Application]. If LIS communication function is closed, the tip “LIS is not connected; cannot apply!” will pop up
during sample registration.
8.2.7.5 Deletion of sample information
If to delete the registered samples, click [Delete Sample] in the “DeleteSample” window as shown in the figure
below.
Fig. 8-2-18
samples. Click [Close] to exit the window.
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Input the samples number or range of sample numbers in the input box, then click [Delete] to delete the specified
● The registered samples that have not been sent for testing are available to be modified or deleted during
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standby or test process.
● Samples under testing or in the to-be-tested status are only available to be deleted under standby mode.
The registered samples that have been audited cannot be deleted directly but can be deleted only after the
audit is cancelled on the “Result Query” interface.
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8.2.8 Prepare test

(1)Prepare detergent, calibration solution, control material and sample
Put the calibration solution, control material, routine samples and STAT samples used for analysis on the proper
position of sample rack, and place the detergent in the correct position.
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a)Place detergent
Place Detergent Ⅰ in the first position of the normal-temperature reagent rack.
Detergent II is placed in the left inner part of the Analyzer.
b)Place calibration solution
Place calibration solution in the relating position of the sample rack as per specified on the “Calibration
Parameters” window.
c)Place control material
Place control material in the relating position of the sample rack as per specified on the “QC Registration”
window.
d)Place sample
Place samples in the relating position of the sample rack as per routine or STAT sample positions specified on the
“Register” window.
The control material and calibration solution should be measured by standard cup.
(2)Start test
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Click and the figure below will be displayed.
Fig. 8-2-19
Click and tick a test type and input information, and then click [Test] to start the test.
8.2.9 During test
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During test, if upper cover of the Analyzer is open, the test process will pause. The uncompleted test items
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shall be sent for testing again after resetting.
(1)Monitor system
When the Analyzer is under operation, the sample rack, reagent chamber, reaction unit, test samples, instrument
state, and feeding mechanism are under real-time monitoring.
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Click “Sys. Monitoring” in the function area, and then the display is as shown below.
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Fig. 8-2-20
a)Click “Sample Rack” to view the real-time status of the rack as shown in the figure below.
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Fig. 8-2-21
The lower part of the window is sample rack status area, and each sample rack has 10 sample positions. If the
Analyzer tests the sample rack in the corresponding position, the sample rack number and relating sample status
will be displayed on the status area. Click the samples of the rack with the mouse, then the sample rack number,
position and sample barcode will be displayed in the above.
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Sample status: the status is shown by different colors.

White means idle.
Blues means to be tested.
Pink means under analysis.
Green means analysis completed.
Gray means unfinished.
Red means invalid barcode.
b)Click “Reagent Chamber” to view the real-time status of the chamber as shown in the figure below.
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Fig. 8-2-22
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Reagent chamber interface includes three fixed positions and three sample racks (1×3+1×6+2×7 positions in
total), and each reagent position is for different kinds of reagents.
It is available to view the temperature of reagent chamber on this interface.
Click the reagent position with the mouse, then the relating information will be displayed, including reagent
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number, reagent rack number, position, type, batch number and test times left.
Reagent status: the status is shown by different colors.
Normal: the reagent is enough for test, in green color.
Insufficient: the volume left is less than the setting volume, in yellow color.
Expired: when the reagent passed the open-vial life or shelf life, in red color.
Non-registered: no reagent is registered in this position, in white color.
Unused: reagent has been registered in this position but has not been enabled on “Reagent Registration”
interface, in blue color.
c)Click “Reaction Unit” to view the real-time status of the reaction unit.
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Fig. 8-2-23
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The reaction unit involves incubation area and test area (incubation area is on the left while test area is on the
right).
The incubation and test temperature are shown in this figure. Click the cuvette to be viewed, and relating test
information will be displayed on the right sides of the window.
The status of current cuvette will be displayed in the status box at right side by characters, and the different
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statuses of cuvette will be displayed on the monitoring diagram on the left wide through different colors at the
same time.
Has cuvette: a cuvette is placed in the reaction unit, in grayish color.
No cuvette: no cuvette is placed on the reaction unit, in white color.
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Add sample: cuvette is being added with samples, in pink color.

Add reagent: cuvette is being added with reagent, in yellow color.
d)Click “Test Sample” to view information list of tested samples. As shown in the figure below:
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Fig. 8-2-24
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e)Click “Machine Status” to view status of each system of the Analyzer. As shown in the figure below:
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Fig. 8-2-25
The instrument status can be read only when the Analyzer is online.
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f)Click “Feeding Mechanism” to view the status of the feeding mechanism of the Analyzer. As shown in the
figure below:
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Fig. 8-2-26
It is available to monitor the loading/use status of feeding box of the feeding mechanism.
(2)Test process
Sample adding sequence: add samples successively by sample numbers, from smallest to largest; and for several
items of the same sample, add samples successively in order of initial letter, from smallest to largest.
(3)Pause or continue
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If to suspend sample adding or to supplement reagent, click shortcuts or ; and if to continue the
test of adding sample or reagent, click or .

In case of reagent adding suspension or alarm that leads to sample adding stop, the probe will also stop adding
sample.
(4)Stop
During test, click , and the Analyzer will stop action immediately.
(5)Add sample
a)Add new sample
During test, the registration of other samples can be executed on the “Register” window, and after registration,
click , input the sample number of the added test in the test sending interface, and then click [Test] to
send the command for adding a test.
b)Add new items for existing sample number
Click [Add item] on the “Result Query” interface, and select the sample number range, dilution or Not, and
sample name on the “Add item” window, and then click [Add]. Click , input the sample number of
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the added test in the test sending interface, and then click [Test] to send command of adding test.
Select the sample of items to be added from sample list at the right side of the “Register” interface and also
the items to be added, then click [Register], and send the command of adding a test by clicking ,
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inputting the sample number of the added test in the test sending interface, and then clicking [Test].
It is available to add items to an existing sample number under standby mode or during test.
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8.2.10 Confirmation of test results
● The test results are affected by samples with hemolysis, lipemia and icterus.
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● The sample shall be clear and free of clots, otherwise the probe will be blocked, causing reverse
consequence to test results.
● Some substances of the samples, like medicine or aseptic, will affect the test results.
● Don’t keep the sample open for a long term, or it will volatilize and the test results will be affected.
● Incorrect parameter setting will affect the test result.
● Any violation against the user manual during “Maintenance” may pollute or damage the Analyzer and
further affect the test results.
● We do not suggest users modify or add the test results. The Company disclaims any due responsibilities.
Click “Results” in the function area, and then the display is as shown below.
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Fig. 8-2-27
Click “Result Query” to view, delete, modify, audit, print report and add items of the test results.
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(1)Intraday results
Click (default) on the “Result Query” window to view the intraday
results. All intraday sample information will be displayed on the workspace list as shown in the figure below.
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Fig. 8-2-28
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User manual
The window displays sample information on the left and item info and test results on the right.
● If cuvette has no sample or reagent, the probe cannot aspirate sample or reagent normally, and the test
result may be incorrect: “S” means no sample, “R” means no reagent, and “!” means there is neither sample
nor reagent, and the result is marked with color.
● If the item which needs calibration is not calibrated, it’s not allowed to send the test; if allowing to send
testing without calibration is set, testing can be done normally.
a)View original results
The “Result Query” interface does not display original results of items.
b)View calibration/QC results quickly
View calibration results quickly
Select one sample on the left list and the item on the right list of “Result Query” interface, then right-click
mouse and select “Display calibration result (Y)” to open the relating calibration result interface, next all
successful calibration results of the item will be displayed on the interface as shown in the figure below.
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Fig. 8-2-29
View QC results quickly
Select one sample on the left list and the item on the right list of “Result Query” interface, then right-click
mouse and select “Display QC result” to open the relating QC result interface, next all QC results of the same
date of test result are screened and displayed on the interface as shown in the figure below.
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Fig. 8-2-30
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c)Audit
If to audit samples, select the record information and click [Audit/Cancel Audit]. Select test date, and input
sample number in the input box of sample number range as per the regulations shown below.
Input single sample number for operation of single sample such as 1; and input multiple numbers for operation of
multiple samples and separate them with English character ‘,’ or ‘-’ wherein ‘,’ stands for and ‘-’ stands for to,
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for example, 1,3-5 means to operate 1#, and 3#~5#. Then click [Audit] to complete the audit as shown in the
figure below.
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Fig. 8-2-31
Click [Close] to exit the “Audit” window.
● When ticking “Only audit sample with complete patient info”, the sample must have a patient name and
all the items have test results so that they can be audited.
● The start sample number of batch validation should be less than or equal to the end sample number.
● User cannot modify or delete the validated samples but can be modify the results only after the audit is
cancelled.
d)Cancel audit
If to cancel the sample audit, click [Audit/Cancel audit], select test date, and input sample number in the input box
of sample number range as per the regulations same to that for audit.
e)Preview and printing of report
Click [Print] and the figure below will be displayed.
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Fig. 8-2-32
Click [Print] on the “Print” window.
Select “Print only audited patients” to print the audited samples instead of samples that have not been printed,
otherwise, all samples within the setting range will be printed.
Select “Skip printed samples” to skip over the printed samples before, otherwise all samples within the setting
range will be printed.
Click [Close] to exit the “Print” window.
f)Add items
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The start sample number of printing should be less than or equal to the end sample number.
For registered samples, the coagulation items can be added no matter whether there are test results. Click [Add
item] in the “Result Query” window to enter in the item adding window, and the display is as shown below.
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Fig. 8-2-33
Select test date and sample number range (as per regulations same to that for audit), then click the abbreviation of
items to be added in the list. Click [Add] to complete the process.
If to send test of added items, click , select test type, and select start sample number and send the test
by clicking [Test].
g)Modification of results
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If to modify a certain sample result, click the test result of the sample in the test results area, then the position will
become grey, next input modified result, and press “Enter” to save the modification.
For the items with modified results, there will be relating marks below the “Modification” character.
If to remove the modification mark, right click at the blank space at right side of history query interface (Fig.
8-2-28) and remove the tick of “Mark modified test results (W)”, then the “Modification” character will not
display.
The user with the administration and operation permission can modify test results within 3 days. The user
with the query permission can only view test results.
h)Deletion of results
If to delete a test item, click the results to be deleted on the “Result Query” window and select [Delete item], and
the dialog box for deleting item will be shown as in the figure below.
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Fig. 8-2-34
Select test date, sample number range and the items to be deleted, and then click [Delete] to delete the record.
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● It’s not allowed to delete all the items of a certain sample.

● The items of audited samples cannot be deleted.
i)LIS transfer
When the Analyzer starts LIS communication, click [LIS Transfer] and the figure below will be displayed.
Fig. 8-2-35
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User manual
Select a test date range from the pull-down menu of “Date Tested”. If to send the results of all test, select “All”
and click [Send], then all required test results will be transferred to LIS system. It is also allowed to send results
under custom mode. First select “User Defined”, and select routine or emergency, then determine the sample
number range and click [Send], then all required test results will be transferred to LIS system.
If LIS function is not used, the [LIS Transfer] button will not be displayed.
(2)Results within three days
Click on the “Result Query” window to view the results within three
days. The specified operations are same to “(1) Intraday results”.
(3)Historical results query
Click “Results” in the functions area, then click “History Query” to enter into the historical results query window as
shown in the figure below.
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Fig. 8-2-36
a)Historical data query
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Query conditions comprises patient name, test date, sex, sample number range, nationality, barcode, section, bed
number, sending department, sending doctor, testing doctor, audit doctor, case number, treatment type, and clinic
diagnosis. Input query conditions in the input box or select them from the pull-down menu, then click [Query] and
the specified record will be displayed in the frame of result list.
Click [Print] to print the acquired reports of historical test results.
b)Historical results comparison
Click the “Results Comparison” option in the “History Query” interface, and the display is as shown below:
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Fig. 8-2-37
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The query can be conducted through two means, i.e., case number and barcode:
Select “By case number” in “Query Conditions”, input case number of query samples, and select the test date
range of samples in the pull-down menu of “Date Tested”.
Select “By barcode” in “Query Conditions”, input barcode of query samples, and select the test time range of
samples in the pull-down menu of “Date Tested”.
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Click [Query], then a new window will pop up, select result statistics based on single or multiple items. Click
[OK], then the results will be displayed in the list box.
Next click [Print] to print the query results.
(4)Result statistics
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Click “Results” in the functions area, then click “Result Stats” to enter into sample results statistics window.
a)Repeatability stats
Click “Repeatability Stats” in the “Result Stats” window as shown in the figure below.
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Fig. 8-2-38
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User manual
If to conduct statistics on repeatability of a certain sample, click “Stats by single sample”, input or select test date
range, sample number, abbreviation and repetitive times, then click [Stats], and the results will be displayed in the
statistics column at the lower part of the window. It is available to view the maximum, minimum, range, mean,
SD and variable coefficient for the convenience of confirming the repeatability of the Analyzer.
If to print the statistics results report, click [Print].
The repeatability stats cannot be conducted if no repeatability tests of at least 3 times have been conducted
for a single sample.
If to conduct repeatability stats for multiple samples on “Repeatability Stats” window, click “Stats by multiple
samples” and the figure below will be displayed.
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Fig. 8-2-39
Select a test time range, sample number range, abbreviation, then click [Stats], and the results will be displayed in
the statistics column at the lower part of the window. It is available to view the maximum, minimum, range, mean,
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SD and variable coefficient for the convenience of confirming the repeatability of the Analyzer.
If the results number of a test item within a test date and sample number range is less than 3, when clicking
[Stats], it’s prompted that “The results number of the current selected item is less than 3; please select again”.
If to print the statistics results report, click [Print].
b)Statistics of positive rate in results
Click “Result PR Stats” in the “Result Stats” window as shown in the figure below.
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Fig. 8-2-40
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Input a test date range and sample number range in statistics condition.
Select either “Items with test results only” or “Items with reference range only” or both the two means to make
statistics to the required sample test results.
Click [Stats], and select the statistics items of the sample in the popup window, then click [OK], and the statistics
result will be displayed in the list box.
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Click [Print] to print the results.
c)Item statistics
Click “Item Stats” in the “Result Stats” window, and select a test date range from the statistics condition and click
[Stats], then the figure below will be displayed.
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Fig. 8-2-41
Click [Print] to enter into the printing preview interface, then click to print the item statistics report.
d)Workload stats
Click “Workload Stats” in the “Result Stats” window as shown in the figure below.
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Fig. 8-2-42
then click [Stats] to complete the statistics analysis.

Click [Print] to preview and print statistics statement.
8.2.11 Recheck of sample
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The workload statistics is purposed to make statistics of testing doctor, sending doctor and testing department.
User should confirm statistics category as per the demand and select test date range in the statistics condition,
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There are two registration methods for sample recheck, i.e., automatic register and manual register where the sample
number will not be changed.
(1)Register of automatic recheck
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Click “Results” in the functions area, then click “Item Recheck”, and the figure below will be displayed.
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Fig. 8-2-43
Click [Set Condition] and the figure below will be displayed.
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Fig. 8-2-44
Select the relating recheck conditions where means being selected, then click [OK]. After sample test, the
Analyzer will add the required sample information to the recheck window.
For recheck test with satisfied conditions, the sample volume is that for the initial test, and the test results will be
displayed in the recheck result row of test result interface.
(2)Register of manual recheck
a)Register of manual recheck for single sample
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If to recheck samples after initial test, select “Recheck” of the sample result column on the “Result Query”
window as displayed as the figure below.
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Fig. 8-2-45
On the “Item Recheck” window, the recheck samples will automatically be displayed in the recheck list. As
shown in the figure below:
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Fig. 8-2-46
Use recheck sample rack
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Select samples to be rechecked, set the rack number and position for recheck in “Recheck info” and decide to
dilute or not, select a dilution plan, then click [Save] and the recheck information setting is over, and changed
rack number and position of the recheck items will be displayed on the list of the recheck area.
Use original sample rack
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Select samples to be rechecked, set the original sample rack number and position in “Recheck info” and decide
to dilute or not, select a dilution plan, then click [Save] and the recheck information setting is over, and rack
number and position of the recheck items will be displayed on the list of the recheck area.
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It is recommended to use the original sample rack for a large volume of recheck to save the preparation time
of test.
b)Register of manual recheck for batched sample
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Click [Batch Registration] on the “Item Recheck” window and the figure below will be displayed.
Fig. 8-2-47
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User manual
Select the sample number range and the items to be rechecked, then click [Register] and the samples will be
added into the recheck list. Refer to “8.2.11 (2) a)-Register of manual recheck for single sample” for other
operations.
(3)Recheck test
After recheck registration, click to select “Recheck test”, and then click [Test].
Only the intraday results can be rechecked.

8.2.12 Analysis ended
(1)Reconfirm results
After test of recheck samples, right click test results on “Test Results” window, and left click “Replace selected
result”, then the recheck results will be added in the “Test Results” column.
If there are more than 1 recheck items, click “Replace all results”, then all recheck results will be added in the “Test
Results” column.
(2)Turn off power (shutdown)
Exit the Analyzer and turn off the power of printer, computer host, display and the Analyzer.
(3)Preparation for subsequent work

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When the system is sleeping, do not turn off the power of the Analyzer for preparation of subsequent work.
Check whether the reagent chamber door is closed, and remove the sample rack. Check whether the probe is
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polluted and bent. Check whether the platform of the Analyzer is contaminated or clean.
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Chapter 9 System Help
In case of any doubts to the functions and operations during use, the operator can click or press “F1” to open
system help.
9.1 Use of System Help

(1)Click the title name to be viewed in the list to view the specific operations. If the description is more than one
page, drag the scroll bar to read the content.
(2)After reading, click to end the help.
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Chapter 10 System Maintenance
10.1 Preparation before system maintenance

To guarantee the accuracy and precision of the Analyzer, operators shall strictly follow User Manual of BCA-1000
Automatic Blood Coagulation Analyzer and regularly provide maintenance for the Analyzer so as to get reliable test
results and ensure the Analyzer with planned service life.
Before maintenance of the Analyzer, please prepare the following tools:
10.1.1 Tools and instruments
Name of tools Function
Cross screwdriver Shield plate for assembly/disassembly of the Analyzer
Probe Unblocking Tool Used for cleaning probe
Nozzle cleaner Used for cleaning blockage of probe
Clean gauze Used for cleaning of all parts
Swab Used for cleaning probe
Dust collector Used for cleaning cooling fan
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Tube brush Used for cleaning the incubation bath
Forceps Clean the reagent chamber
10.1.2 Pure water

During routine operation and system maintenance, the Analyzer shall be filled with pure water with conductivity
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lower than 1μs/cm. Don’t forget to conduct regular maintenance and check the pure water unit. Refer to the
description of the pure water unit for details to contact to the manufacturer or seller.
10.1.3 Detergent
The detergent is used for cleaning all parts of the Analyzer. The detergents should be purchased from Dirui
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Company, otherwise if they are replaced by others, the probe, rinsing bath or pipelines may not be clean, which may
impact the accuracy and precision of the test results. The company will not be responsible for any inaccuracy due to
failure to use detergent as specified.
There are two kinds of detergent used for the coagulation analyzer:
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(1)Detergent I (detergent of probe inner wall): put Detergent I in position 1 of the normal temperature reagent rack
and the probe will aspirate Detergent I and move to the rinsing bath to clean the probe inner wall during
maintenance.
(2)Detergent II (detergent of probe outer wall): put Detergent II in the “Detergent II” position at left rear part of the
Analyzer, and the probe will aspirate detergent II and move to the rinsing bath to clean the probe outer wall during
maintenance.
10.2 Analyzer resetting
Click in the auxiliary buttons area, and each mechanism of the analyzer automatically returns to the
resetting point. Stop is allowed during resetting. But you cannot execute tests or other maintenance operation until
instrument standby.
The analyzer reset action should be performed when the alarm message indicates that the operator should perform
a reset, or after a stop in the middle, or when performing a probe single-step motion adjustment.
10.3 Application of “Maintenance” window

Click the “Maintenance” option in the functions area to enter into the maintenance window, and then set the daily
maintenance, weekly maintenance and monthly maintenance as per the demand.
10-1
User manual
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Fig. 10-3-1
During maintenance of the Analyzer, if to suspend the maintenance action, click in the middle of prompt
column on the software window to terminate the maintenance; however, it is not allowed to suspend some
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maintenance actions, and other actions can proceed only after the current maintenance is over. In case of any
abnormal mechanism during maintenance, an alarm prompt will be displayed on the “Alarm info” window.
10.3.1 Mechanical motion check
Click “As required” on the “Maintenance” window, and select “Mechanical Motion Check” from the list, then the
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figure below will be displayed.

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Fig. 10-3-2
Input test times in the input box of “Number of Checks” and click [Execute], then the Analyzer will reset first, and
enter into mechanical motions check process automatically in case of no errors. During mechanical motions check,
observe whether the position of mechanism is normal and the execute operation is correct. In case of abnormal
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User manual
condition, stop the mechanical motions check immediately, and conduct troubleshooting as per the alarm
information.
10.3.2 Tubing drainage
Click “As required” on the “Maintenance” window, and select “Tubing Drainage” from the “Integral Maintenance”
list, and then the figure below will be displayed.
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Fig. 10-3-3
Remove the water supply pipe, pure water float switch and large hole filter net from the pure water tank and take
the pipe out of the Detergent II bottle. Click [Execute], and the Analyzer will reset automatically, then conduct pipe
emptying check in case of no error. If there are any abnormal conditions, take troubleshooting measures as per the
alarm information.
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10.3.3 Tubing exhaust

Click “As required” on the “Maintenance” window, and select “Tubing Exhaust” from the list, and then the figure
below will be displayed.
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Fig. 10-3-4
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User manual
Click [Execute], and the Analyzer will reset automatically, then conduct pipeline exhausting check in case of no
error. If there are any abnormal conditions, take troubleshooting measures as per the alarm information.
10.3.4 Vertical check for probe
Click “As required” on the “Maintenance” window, and select “Probe Vertical Check” from the list, then the figure
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Fig. 10-3-5
Click [Execute] and the analyzer enters the single step check action flow. Click [Step 1], [Step 2] and [Step 3] to
proceed with the next action in order. Click to stop this maintenance action. Click , and the
analyzer will automatically enter the standby state.
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10.3.5 Horizontal check for probe

Click “As required” on the “Maintenance” window, and select “Probe Horizontal Check” from the list, then the
figure below will be displayed.
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Fig. 10-3-6
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User manual
Tick “Probe Horizontal Check”, click [Execute], it’s prompted that “Please execute only if the upper cover is
opened”, open the upper cover of the analyzer, click [Yes] on the prompt interface, and the analyzer enters the
single step check action flow. Click [Step 1], [Step 2] and [Step 3] to proceed with the next action in order. Click
to stop this maintenance action. Click , and the analyzer will automatically enter the standby
state.
10.3.6 Check clamp position
Click “As required” on the “Maintenance” window, and select “Clamp Position Check” from the list, then the figure
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Fig. 10-3-7
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Tick “Clamp Position Check”, click [Execute], it’s prompted that “Please execute only if the upper cover is
opened”, open the upper cover of the analyzer, click [Yes] on the prompt interface, and the analyzer automatically
performs resetting and clamp position check. During the check process, observe whether the clamp is at right
positions and the action position is correct. In case of abnormal condition, stop the check immediately, and conduct
troubleshooting as per the alarm information.
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10.3.7 Check photometer

Click “As required” on the “Maintenance” window, and select “Photometer Check” from the list, then the figure
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User manual
Fig. 10-3-8
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Click [Execute], and the Analyzer will reset automatically, then conduct photometer check and list the check results
in the list at the right side in case of no error. If there are any abnormal conditions, stop the check immediately and
take troubleshooting measures as per the alarm information.
10.3.8 Probe rinse
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On the “Maintenance” window, click the “Daily Maintenance” option, select “Probe Rinse” from the list, and the
interface is as shown below:
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Fig. 10-3-9
Click [Execute], and the analyzer is reset automatically; after correct resetting, probe rinse is performed; while the
probe is rinsed, observe whether the probe aspirates Detergent I (probe inner wall detergent), Detergent II (probe
outer wall detergent) and pure water, and whether the probe rinse operation is performed in the correct way. When
any abnormality occurs, the check is stopped. Handle according to the corresponding alarm message.
10.3.9 Reagent shaking check
On the “Maintenance” window, click the “Daily Maintenance” option, select “Reagent Shaking Check” from the
list, as shown below:
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Fig. 10-3-10
Click [Execute], and the analyzer is reset automatically. After that, carry out Reagent Shaking Check, and notice
according to the corresponding alarm message.

10.3.10 Tubing Automatic Rinse 疗
whether the reagent mixing sound can be heard twice. When any abnormality occurs, the check is stopped. Handle
On the “Maintenance” window, click the “Weekly Maintenance” option, and select “Tubing Automatic Rinse”
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from the list, as shown below:
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Fig. 10-3-11
Click [Execute], and the analyzer is reset automatically. After that, carry out Tubing Automatic Rinse. When any
abnormality occurs, the check is stopped. Handle according to the corresponding alarm message.
10.3.11 Waste Liquid Tube Rinse
On the “Maintenance” window, click the “Monthly Maintenance” option, and select “Waste Liquid Tube Rinse”
from the list, as shown below:
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Fig. 10-3-12
Click [Execute], and the analyzer is reset automatically. After that, carry out Waste Liquid Tube Rinse. When any
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abnormality occurs, the check is stopped. Handle according to the corresponding alarm message.
10.4 System maintenance position and parts

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If the Analyzer is installed with accessories which are not provided or recommended by the manufacturer or
the Analyzer is used otherwise specified by the manufacturer, the relating protection may be weakened.
10.4.1 Clean, check and replace parts regularly
Clean, check and replace parts regularly as shown in Table 10-4-1 (providing the Analyzer is used for 4 hours per
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day):
(○: Clean and check regularly ●: Replace and add regularly)
Table 10-4-1 List of Parts to be Cleaned, Checked and Replaced Regularly
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Cycle
No Items Reference
Appropriate
Daily Weekly Monthly
time
1 Incubation and test position ○ 10.5.2
2 Manual-cleaning probe ○ 10.5.1
3 Probe rinsing bath ○ 10.5.1
4 Waste box ○ ——
5 Probe syringe pump ● 10.5.9

Detergent I
6 ● ——
Detergent II
7 Reagent refrigeration chamber ○ 10.5.3
8 Normal-temperature reagent position ○ 10.5.3
9 Sample chamber ○ 10.5.4
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User manual
Cycle
No Items Reference
Appropriate
Daily Weekly Monthly
time
10 Cooling fan and dust cover ○ 10.5.8
11 Printing paper, colored tape, ink and toner
● Specifications
(Note a) cartridge
12
Pure water unit ● Specifications
(Note b)
13 Pure water tank ○ 10.5.5
Notes:
a)The Analyzer can be equipped with stylus, ink-jet or laser printer, and user can select consumables as per
the type of printer.
b)If the conductivity is pure water is more than 1μs/cm, please contact the seller of the pure water unit for
troubleshooting.
10.4.2 Spare parts for regular replacement and maintenance
Please prepare the following parts all the time for repairing the Analyzer at any time in case of faults. The parts are
shown in Table 10-4-2.
No.
1
Part name
Colored tape, ink and toner cartridge

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Table 10-4-2 List of Spare Parts
Remarks
Used for stylus, ink-jet or laser printer

Qty./year
Appropriate amount
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2 Printing paper Used for printing Appropriate amount
3 Probe Used for aspirating sample and reagent 1

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4 Probe syringe pump Used for sample-aspirating of probe 1
10.5 Maintenance methods

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● Don’t spill water, reagent detergent or other solutions on the machine or electric parts of the Analyzer in
case of any damages.
● Don’t touch probe or mechanical arm during operation of the Analyzer in case of infection or injury.
● During operation, the operators shall take preventive measures like wear protective gloves, glasses,
working suits in case of infection due to touch with polluted area or solution or skin injury due to contact
with corrosive liquid. The operator shall rinse with water and take disinfection measures after contact with
the polluted or corrosive liquid due to carelessness.
● During maintenance process, please check whether there are hazards caused by inefficiency of hoses or
parts filled with solution.
10.5.1 Probe cleaning
The inner/outer wall of the probe may have plasma, reagent or dip, or is easy to be blocked after long term of use, as
a result the test results of the Analyzer may be affected.
(1)Cleaning of probe tip surface
a)Turn off the power of the Analyzer.
b)Remove the probe to upper side of the rinsing bath.
c)Wipe the surface of the probe with swab dipped in alcohol.
d)After cleaning, no crystals are allowed on the probe surface.
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Don’t put a large amount of alcohol near the Analyzer during use providing the alcohol is inflammable.
(2)Cleaning of blocked probe
If the Analyzer has the alarm of “probe blocked” or the liquid from the probe is discontinuous or flows in strands,
the probe shall be cleared.
a)Turn off the power of the Analyzer;
b)Remove the probe by using the accompanying tools;
c)Connect the contact at the end of probe unblocking tooling with the contact on the probe, take a clean cuvette,
and inject Detergent II; then put the probe into the detergent in the cuvette and pull the piston of the syringe to
aspirate the detergent; finally expel the detergent after 5 min. If failed to unblock the probe, soak the probe in hot
water for 5 min, and pull/push the injector piston repeatedly.
d)After step c), if the probe still cannot exhaust fluid, the blockage is very serious, then use the probe unblocking
needle to penetrate the probe tip for cleaning again.
Afterwards, repeat step c) with nozzle cleaning tooling.
e)After the cleaning is completed, the probe is restored to its original state in reverse order. Turn on the
analyzer power switch, click [Machine Maintenance] in the “Maintenance” window, select “Tubing Exhaust”,
and click [Execute] to perform the pipe exhaust operation once.
(3)Cleaning of rinse tank
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a)If the rinse tank is polluted, use the tube brush dipped in Detergent II to rinse;
b)Then inject Detergent II of about 10mL into the rinse tank; and pour pure water of about 100mL in each rinse
tank for flushing.
After flushing, the dirt in the rinsing bath can be removed, and the bacteria can be inhibited to grow and breed.
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Generally, the cleaning process shall be conducted once every month. The dirt of the Analyzer discovered during
use shall be cleared promptly.
10.5.2 Rinsing of incubation and test position
The dust of incubation and test position shall be cleared timely after long term of use or those positions may become
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polluted. Specific steps are as follows:

(1)Turn off the power of the Analyzer;
(2)Wipe the holes with swab dipped in alcohol;
(3)Check whether the hole has impurities after wiping, and clear them if any to avoid impact of the accuracy of test
迪
results.
(4)Turn on the switch of the analyzer, and execute the photometer check once. For detailed operation refer to
“10.3.7 Check photometer”.
Don’t put a large amount of alcohol near the Analyzer during use providing the alcohol is inflammable.
10.5.3 Reagent chamber cleaning
(1)Refrigerating reagent chamber
After test each day, clean the refrigerating reagent chamber by wiping with gauze that is picked up by forceps.
(2)Normal-temperature reagent rack
Place Detergent Ⅰ and diluent in the normal temperature reagent rack. If some detergent and/or diluent are stuck to
the normal temperature reagent rack, wipe the position with alcohol-dipped gauze that is picked up by forceps.
10.5.4 Sample chamber cleaning
When the sample chamber is dirty, wipe it with alcohol-dipped gauze that is picked up by forceps in case that there
is difficulty or jamming during pushing sample rack into the sample channel.
10.5.5 Pure water tank cleaning
The pure water is placed outside of the instrument, and shall be connected with the Analyzer through pipeline. The
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User manual
pure water of the Analyzer shall be prepared by external pure water device and added into the pure water tank. Any
dust or foreign matters falling into the pure water tank during replacing the pure water will block the pure water
pipeline, affect normal operation of the Analyzer, and further affect the accuracy of test results. At this time the pure
water tank and pure water filter net should be cleaned in a timely manner.
10.5.6 Pure water tank large hole filter cleaning
(1)Turn off the power switch on the right side of the analyzer, unscrew the pure water tank cap counterclockwise,
and take out the pure water float switch and the large hole filter in the tank, as shown in the figure below:
Fig. 10-5-1
疗
(2)Prepare containers such as a bucket to hold water. After unplugging the large-hole filter joint, rinse the
large-hole filter repeatedly with the distilled water on the front and back sides until the surface of the large-hole
filter is cleaned.
(3)Install the large-hole filter and the pure water float switch back to the original position, and turn on the power
医
switch on the right side of the analyzer.
(4)Perform pipeline exhaust operation once: Click “Machine Maintenance” in the “System Maintenance” window,
select “Tubing Exhaust”, and click “Execute”.
10.5.7 Detergent II filter cleaning
瑞
(1)Turn off the power switch on the right side of the analyzer, open the detergent cover door on the left side of the
analyzer, take out the Detergent II bottle, unscrew the bottle cap counterclockwise, and take out the pipe and filter
in the bottle, as shown below:
迪
Fig. 10-5-2
(2)Prepare containers such as a bucket to hold water. After unplugging the large-hole filter joint, rinse the
large-hole filter repeatedly with the distilled water on the front and back sides until the surface of the large-hole
filter is cleaned.
(3)Install the filter and pipeline back into place and turn on the power switch on the right side of the analyzer.
Detergent II filter should be cleaned once a month.
10.5.8 Cleaning of cooling fan and dust cover
Providing the cooling fan and dust cover will have dust on its surface after long term of use, so they should be
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User manual
cleaned every month.

(1)Cleaning of cooling fan
a)Turn off the general power of the Analyzer.
b)Clear the dust of cooling fan with dust collector.
(2)Cleaning of dust cover
a)Remove the dust cover by using the accompanying tools.
b)Clear dust with the dust collector.
c)Clean the cover with pure water.
d)Reinstall the dust cover after wiping it clearly with cloth.
10.5.9 Syringe pump
The syringe pump has a service life about 2 million times, and should be replaced every three years in general.
Please contact consumer-service staff for replacement.
Use pure water to clean surface of syringe pump instead of alcohol or other organic solution.
10.5.10 Overheating protection device check
The incubation/testing assembly have an overheating protection device. It should be checked once a year in order
疗
to ensure normal operation of the analyzer.
Insert the temperature sensor into the incubation hole, and read the temperature 3 minutes later. If the temperature
is over high or over low, please contact the customer service personnel.
10.5.11 Liquid level protection device
医
To ensure normal operation of the analyzer, the liquid level protection device should be checked once a year. If
there is an abnormal result, please contact the customer service personnel.
(1)Unscrew the cap of the pure water tank, and take the float out, as shown below:
瑞
迪
Fig. 10-4-3 Pure water sensor

Pull the pure water sensor out of the analyzer, and use the multi-purpose gauge to measure the float on-off status.
Switch the multi-purpose gauge to the ohms shift buzzer status, use the red and black gauge probe to respectively
touch the two-core metal terminal in the sensor, and use hand to move the float ball up and down; if the buzzing
status of the buzzer changes, the pure water float status is normal.
Fig. 10-4-4 Pure water float
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User manual
(2)Unscrew the cap of the waste liquid tank, and take the float out, as shown below:
Fig. 10-4-5 Waste liquid sensor

(3)Pull the waste liquid sensor out of the analyzer, and use the multi-purpose gauge to measure the float on-off
status. Switch the multi-purpose gauge to the ohms shift buzzer status, use the red and black gauge probe to
respectively touch the two-core metal terminal in the sensor, and use hand to move the float ball up and down; if
the buzzing status of the buzzer changes, the pure water float status is normal.
疗
医
瑞
Fig. 10-4-6 Waste liquid float

(4)After testing, restore the pure water tank and waste liquid tank assembly.
(5)Cover the analyzer with the dust-proof hood, so as to keep the surface of the analyzer clean.
10.5.12 Maintenance of the Analyzer before stop and storage description
迪
Take the following measures to maintain the Analyzer before maintenance or treatment, or not used for long:
(1)Take out all reagent bottles and samples, and discharge the calibration solution and QC solution.
(2)Empty the pipeline in “Maintenance” as detailed in “10.2.6 Pipeline emptying”.
(3)Remove all the connection cables and store carefully, avoiding twisting and damaging them.
(4)Remove all the connection hoses and store carefully.
(5)Cover the analyzer with the dust-proof hood, so as to keep the surface of the analyzer clean.
10.5.13 Cleaning and maintenance of the Analyzer
Clean the surface of the analyzer regularly to keep it tidy. Wipe the surface with a wet and soft cloth or gauze,
dipped in detergent of small amount if necessary. Don’t wipe it with any organic solvent in case of damages to the
case.
The operator shall pay attention to the following matters during cleaning.
(1)Take proper disinfection measures in case of hazardous substance leaked on the surface or inside the equipment.
(2)Don’t use the detergent or sanitizer with possibility of danger due to chemical reaction with parts or materials in
equipment.
(3)In case of doubts about the compatibility between the sanitizer or detergent and parts or materials in equipment,
please consult the manufacturer or its agent.
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User manual
10.5.14 Waste treatment

(1)The Analyzer will generate two kinds of wastes during normal operating process:
a)Waste liquid: it is generated during testing process, containing plasma and various coagulation reagents.
b)Waste cuvette: the cuvette had been used for test, containing liquid after reaction.
(2)According to the national laws and regulations, the waste liquid shall be discharged only after disinfection, and
the wastes generated by the Analyzer shall be handled as per the following principles:
a)Waste liquid: the “84 disinfectant” and waste liquid can be mixed up at scale of 1:50 for disinfection before
discharging.
b)Waste cuvette: the waste cuvette, as medical waste, shall be handled as per the national laws and regulations.
● Please handle the waste liquid of the Analyzer to prevent potential biological and chemical pollution.
● The waste cuvette shall not be abandoned together with household refuses.
10.6 Treatment of scrapped analyzer

Do not abandon the Analyzer randomly after its service life but inform the manufacturer for recycle.
疗
医
瑞
迪
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Chapter 11 Alarm and Treatment of the Analyzer
11.1 Type of alarm message

The alarm message is divided into data alarm and fault alarm as per different contents. The data alarm is classified as
per its caution level, and can be divided into caution alarm, sample-stopping alarm and stop alarm. In case of
different types of alarm, the Analyzer will act as per Table 110-1-1.
Table 11-1-1 Actions of the Analyzer after Alarm
Type of alarm message Actions of the Analyzer

The objects of alarm are the tested results (caution level). The Analyzer will continue the
Data alarm
analyzing test.
It occurs both during data alarm and fault alarm, but the operation will continue. The operator shall
Caution level alarm
decide whether to continue the analysis or not as per specific conditions.
Sampling pause level The objects of alarm are the fault of the Analyzer. The adding process of new samples is stopped.
alarm The analyzing process of the samples added into the cuvette shall be continued.
The objects of alarm are the fault of the Analyzer. The Analyzer stops working immediately. The
Stop level alarm
test results are untrustworthy.
11.2 Solutions for non-alarm faults

11.2.1 Abnormal data of non-alarm faults
疗
Some problems of the test data may not lead to alarm, however, those abnormal conditions can be discovered by
measuring the control material, and rechecking and observing the status of the Analyzer.
医
The data fault and solutions without alarms are shown in Table 11-2-1.
Table 11-2-1 Data Fault and Solutions without Alarms
Faults
Main causes Solutions
瑞
Examples
1. The Analyzer is not maintained correctly and 1. Maintain the Analyzer regularly as per the User Manual.
regularly. 2. Replace reagent, and save and use the reagent correctly.
2. The reagent is going bad, having chemicals 3. Keep the conductivity of pure water at 1μs/cm.
Poor dissolved or mixing with impurities.
4. Replace the reagent.
迪
repeatability 3. The quality of pure water is poor.

5. Conduct centrifugalization for unqualified samples again.
4. The reagent has crystals.
5. The samples are unqualified (have fibrous
protein).
1. The calibration solution is concentrated or 1. The calibration solution shall be used once after being
Poor ineffective. added into the sample cuvette and saved well.
accuracy 2. The formula of reagent is not correct. 2. Replace the reagent.
3. The conditions for analysis are poor. 3. Set the parameters correctly.
The above conditions are only examples, and the data abnormities during test shall be analyzed as per the
specific causes.
11.2.2 Faults of the Analyzer without alarm
The Analyzer fault and solutions without alarms are shown in Table 11-2-2.
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User manual
Table 11-2-2 Analyzer Fault and Solutions without Alarms
Fault message Main causes Solutions
1. The probe tip is dirty.

Probe tip with 1. Wipe the probe with swab dipped in alcohol.
drips 2. The pipeline or syringe pump of the filling
2. Conduct maintenance and inspection.
mechanism has leaks.
Syringe pump has
The interface is installed incorrectly. Reinstall it after confirming there are water leaks.
leaks
1. Reinstall it after confirming the unfavorable part.
The syringe pump 1. The interface is installed incorrectly. 2. Execute exhaust process in the system; if the micro
has bubbles bubbles cannot be removed, knock the syringe pump
2. The syringe pump cannot exhaust completely.
slightly when the reagent or detergent are flowing to
eliminate the bubbles by making use of vibration.
11.3 Alarm message and solutions

Alarm code Alarm level Specific description Reference solutions
a. Please check whether the LIS connecting
state icon at the right bottom is disconnected;
b. If it is disconnected, please select the
system setting menu, go to the
疗
communication setting interface, and check
Current LIS is not connected; whether LIS is enabled;
0-1 Caution level
cannot perform sample application c. If LIS is not enabled, please select enable
LIS and test the connection;
d. If the connection test failed, please check
the connecting device or check whether LIS
医
server is on or not and whether it can work
normally.
a. Check whether LIS server has related
Sample No.{0} LIS application sample info;
0-2 Caution level
failed b. Check whether sample placement is
correct.
瑞
a. Check whether LIS server has related

Sample Barcode {0} LIS sample info;
0-3 Caution level
application failed b. Check whether sample placement is
correct.
a. Please check whether LIS server matches
0-4 Caution level Item info is invalid
迪
the host computer software item info;

a. Please check whether LIS server matches
0-5 Caution level Item info is invalid
the host computer software item info;
a. Please check the host computer software
0-6 Caution level Sending sample data to LIS failed.
and LIS communication connection status;
a. Please check the host computer software
0-7 Caution level Sending QC data to LIS failed.
and LIS communication connection status;
Rack No. {0} position {1} {2}
0-8 Caution level reagent's volume left is less than or a. Please add the reagent.
equal to {3} mL
0-9 Caution level Reagent is expired a. Please replace the reagent.
a. Please execute calibration again;
0-10 Caution level QC result exceeded 3SD b. Please check whether the reagent
placement is correct.
a. Please execute calibration again;
0-11 Caution level QC result exceeded 2SD b. Please check whether the reagent
placement is correct.
0-12 Caution level Sample rack is unavailable a. Please replace the sample rack.
a. Please check whether a barcode is pasted to
the sample cup.
0-13 Caution level Sample barcode is invalid b. Please check whether the barcode is valid;
c. Please check whether the barcode pasting
position is correct.
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User manual

Middle result is too low to be
0-14 Caution level a. Please set the computer parameters again.
calculated by formula
During calculation the
denominator is 0; cannot calculate
Test result exceeded the upper
limit of the analysable range
0-17 Caution level Calibration is expired a. Please calibrate again.
0-18 Caution level QC is expired a. Please execute QC again.
0-19 Caution level Fitting failed a. Please calibrate again.
Rack No. ｛0｝position ｛1｝reagent a. Please use correct reagent barcode;
0-20 Caution level
barcode ｛2｝analysis failed b. Please check the reagent barcode.
Rack No. ｛0｝position ｛1｝reagent a. Please use correct reagent barcode;
0-21 Caution level
barcode ｛2｝barcode is invalid b. Please check the reagent barcode.
Procedure analysis failed: a. Attempt: start software again, and test
0-22 Caution level
unknown test manner again.
Procedure analysis failed: some
procedure cannot analyze reagent a. Attempt: start software again, and test
0-23 Caution level
adding time calculation start again.
point-sample volume
Procedure analysis failed: some
procedure cannot analyze reagent
0-24
0-25
Caution level
Caution level
adding time calculation start
point-second asiprated sample
volume
疗
Procedure analysis failed: Cannot
perform analysis when sequencing
a. Attempt: start software again, and test
again.

again.
医
procedures
Procedure analysis failed: without a. Attempt: start software again, and test
0-26 Caution level
reaction reagent info again.
Procedure analysis failed: the
procedure performs the external
2nd dilution directly without a. Attempt: start software again, and test
瑞
0-27 Caution level

performing the external 1st again.
dilution; has 2nd dilution sample
volume
external 1st dilution parameters of a. Attempt: start software again, and test
0-28 Caution level
迪
the procedure do not match; has no again.

diluent volume
procedure performs the external
0-29 Caution level 2nd dilution directly without
again.
performing the external 1st
dilution; has 2nd diluent volume
external 2nd dilution parameters of
0-30 Caution level the procedure do not match; has no
again.
2nd sample volume or 2nd diluent
volume
There is an item without
0-31 Caution level corresponding procedure in the
again.
sequencing tests
The number of sequencing beats
0-32 Caution level that are applied for is so small that
again.
the sequencing failed
0-33 Caution level Not enough incubation channel
again.
0-34 Caution level Not enough Clotting test Channel
again.
0-35 Caution level Not enough Immuno test channel
again.
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User manual

Not enough chromogenic test a. Attempt: start software again, and test
0-36 Caution level
channel again.
Some test which has already
0-37 Caution level started has no corresponding test
again.
info
Procedure initialization failed; a. Attempt: start software again, and test
0-38 Caution level
cannot carry out test sequencing again.
Sample No. {1}, item {0}, test
repeat times {2}: searching a. Check the testing process, correctly
0-39 Caution level reaction start time failed configure analytical parameters, and test
(parameters setting range is over again
large, or not exceed threshold).
Sample No.{1}, item {0}, test
0-40 Caution level reaction end time failed; method 1 configure analytical parameters, and test
threshold setting is over low as again
compared to the test process
a. Check the testing process, correctly
repeat times {2}: searching
0-41 Caution level configure analytical parameters, and test
reaction end time failed; method 2
again
was used
疗
parameters are not proper or again
reaction is abnormal
医
threshold setting is over low again
compared to the test process
repeat times {2}: searching
reaction end time failed; internal
again
parameters used invalid method
瑞
Sample No.{1}, item {0}, test a. Check the testing process, correctly
0-45 Caution level repeat times {2}: time 1 step-type configure analytical parameters, and test
curve ratio check failed again
迪
curve ratio check failed again

repeat times {2}: not coagulate
again
repeat times {2}: outside range
again
0-49 Caution level repeat times {2}:transmission light configure analytical parameters, and test
intensity is low again
0-50 Caution level repeat times {2}: transmission configure analytical parameters, and test
light intensity is high again
0-51 Caution level repeat times {2}: noise configure analytical parameters, and test
interference again
0-52 Caution level repeat times {2}: prozone check configure analytical parameters, and test
error: reaction is too slow again
error: start angle 1 again
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User manual

error: start angle 2 again
error: prozone again
0-56 Caution level repeat times {2}: initial configure analytical parameters, and test
fluctuation fell again
0-57 Caution level repeat times {2}: data buffer area
again.
is empty
curve difference check failed again
0-59 Caution level repeat times {2}:time 2 step-type configure analytical parameters, and test
curve difference check failed again
0-60 Caution level repeat times {2}: coagulability is configure analytical parameters, and test
too low again
repeat times {2}: skip
疗
again
repeat times {2}: step-type curve;
there is a over smooth area, more
again
than 1s
医
0-63 Caution level repeat times {2}: FBG reliability is configure analytical parameters, and test
low again
0-64 Caution level repeat times {2}:fall dramatically, configure analytical parameters, and test
threshold error again
瑞
0-65 Caution level repeat times {2}:fall dramatically, configure analytical parameters, and test
ratio error again
Sample No. {1}, item {0}, test
repeat times {2}: step-type curve;
there is a relatively smooth area,
again
迪
but the time is less than 1s.

0-67 Caution level repeat times {2}: parameters configure analytical parameters, and test
validity check failed again
0-68 Caution level repeat times {2}: linear interval is configure analytical parameters, and test
over narrow again
intensity is high again
intensity is low again
repeat times {2}: reaction is over
violent or reaction tendency is
again
abnormal
0-72 Caution level repeat times {2}:antigen detection configure analytical parameters, and test
error 1 again
0-73 Caution level repeat times {2}:antigen detection configure analytical parameters, and test
error 2 again
11-5
User manual

repeat times {2}:parameters setting
abnormal: perhaps start time is
bigger than summary time, or
again
linear detection parameters are
over big
intensity high again
intensity low again
0-77 Caution level repeat times {2}: tendency configure analytical parameters, and test
abnormal again
repeat times {2}: over violent and
autocorrelation coefficient is lower
again
than threshold
repeat times {2}: over violent
again
疗
repeat times {2}: no linearity
again
Current communication is
0-81 Caution level abnormal; please disconnect and a.please disconnect and then connect again!
then connect again
{0}error occurred; may affect a. Check the testing process, correctly
医
0-82 Caution level testing Please contact the configure analytical parameters, and test
after-sales engineer again
The fitting degree is below the
0-83 Caution level a. Please calibrate again.
system default.
Test result exceeded the lower
瑞
limit of the analysable range

Test item {0} monotonicity check
0-85 Caution level a. Please calibrate again.
failed
Sample in the sample rack {0}
a. Check whether the sample volume in the
0-86 Caution level rack {1} position is skipped;
position is sufficient
corresponding test is removed
迪
Reagent in the reagent rack {0}

a. Check whether the reagent volume in the
0-87 Caution level rack {1} position is skipped;
position is sufficient
corresponding test is removed
The sample type {0} of the a. Check whether the sample type registration
0-88 Caution level
application is of the wrong type of the related sample of LIS server is correct.
Failed to send sample type {0} to
0-89 Caution level a.Please try again
LIS
Sample-adding Insufficient supplies, please
0-90 a.Please recharge
stop level recharge
0-91 Caution level Deviation in reaction curve a. Please restart software
Received original test data length
0-92 Caution level a.Please restart software
error
Sample barcode error, Rack a.Please check the corresponding location
0-93 Caution level
No.{0} Position{1} sample barcode information
Sample barcode repeat, Rack a.Please check the corresponding location
0-94 Caution level
No.{0} Position{1} sample barcode information
Reagent barcode repeat, Rack a.Please check the corresponding location
0-95 Caution level
No.{0} Position{1} reagent barcode information
Reagent information does not
a.Please check the reagent recharge
0-96 Caution level exist, please use after recharging,
information
Rack No.{0} Position{1}
0-97 Caution level Repeat test ID
again.
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User manual

Sample No.{1}, item a.Please check whether the remaining reagent
0-98 Caution level
{0},automatic recheck test fail is enough.
a. Call out the system maintenance window,
please execute "Reset" first, and then execute
Zeroing timeout when the probe is "Mechanical Motion Check".
2-500 Stop level
reset b. Please contact maintenance personnel if the
fault cannot be eliminated or other fault
appears.
Timeout of scanning of X-axis "Mechanical Motion Check".
2-501 Stop level
tooth fork when the probe is reset b. Please contact maintenance personnel if the
appears.
Timeout of scanning of Y-axis "Mechanical Motion Check".
2-502 Stop level
tooth fork when the probe is reset b. Please contact maintenance personnel if the
appears.
Timeout of reset of syringe pump "Mechanical Motion Check".
2-503 Stop level
疗
when the probe is reset b. Please contact maintenance personnel if the
appears.
Probe cleaning timeout when the "Mechanical Motion Check".
2-504 Stop level
医
probe is reset b. Please contact maintenance personnel if the
appears.
Probe control board, timeout of
"Mechanical Motion Check".
瑞
2-511 Stop level mechanical operation check on

b. Please contact maintenance personnel if the
sampling
appears.
迪

sample release
appears.
cleaning
appears.
Probe control board, timeout of "Mechanical Motion Check".
2-514 Stop level
sampling test b. Please contact maintenance personnel if the
appears.
2-515 Stop level
sample release test b. Please contact maintenance personnel if the
appears.
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User manual

2-516 Stop level
cleaning test b. Please contact maintenance personnel if the
appears.
and execute "Reset".
Probe control board powering-up
2-517 Stop level b. Please contact maintenance personnel if the
rinse timeout
appears.
a. Please delete or disenable the reagents not
2-518 Stop level Reagent info table outside range
to be used.
2-519 Stop level Test protocol outside range a. Please delete the redundant test items.
2-520 Caution level Abnormal probe step count
appears.
Zeroing timeout when the gripper "Mechanical Motion Check".
疗
2-550 Stop level
is reset b. Please contact maintenance personnel if the
appears.
医
Timeout of scanning of X-axis "Mechanical Motion Check".
2-551 Stop level
tooth fork when the gripper is reset b. Please contact maintenance personnel if the
appears.
瑞
Timeout of scanning of Y-axis "Mechanical Motion Check".

2-552 Stop level
tooth fork when the gripper is reset b. Please contact maintenance personnel if the
appears.
迪
Timeout of reset of reagent mixing "Mechanical Motion Check".

2-553 Stop level
mechanism b. Please contact maintenance personnel if the
appears.
Timeout of waste cuvette cleaning "Mechanical Motion Check".
2-554 Stop level
when the gripper is reset b. Please contact maintenance personnel if the
appears.
When resetting the clamping jaw, and execute "Reset".
2-555 Stop level timeout of XY axis zeroing b. Please contact maintenance personnel if the
occurred fault cannot be eliminated or other fault
appears.
Gripper control board, timeout of
Sample-adding "Mechanical Motion Check".
2-561 mechanical operation check on
stop level b. Please contact maintenance personnel if the
cuvette loading
appears.
11-8
User manual

2-562 mechanical operation check on
mixing
appears.
disposal of waste cuvette
appears.
gripper zeroing
appears.
Gripper control board, timeout of "Mechanical Motion Check".
2-565 Stop level
cuvette loading test b. Please contact maintenance personnel if the
appears.
2-566 Stop level

mixing test 疗
医
appears.
Gripper control board, timeout of "Mechanical Motion Check".
2-568 Stop level
disposal test for waste cuvette b. Please contact maintenance personnel if the
瑞
appears.
Timeout of reset of temperature "Mechanical Motion Check".
2-600 Stop level
control board b. Please contact maintenance personnel if the
迪

appears.
Timeout of water level detection
2-601 Stop level for water tank of temperature
control board
appears.
a. Fill the water tank with water.
b. Call out the system maintenance window,
Sample-adding
2-602 Water tank water level low "Mechanical Motion Check".
stop level
c. Please contact maintenance personnel if the
appears.
a. Please empty the waste liquid tank.
Sample-adding
2-603 Waste liquid tank full "Mechanical Motion Check".
stop level
appears.
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User manual

a. Please empty the Waste box.
Sample-adding
2-604 Waste box full "Mechanical Motion Check".
stop level
appears.
a. Put the Waste box in the right place.
2-605 Stop level Waste box is not in place
appears.
a. Fill the cleaning tank with cleaning fluid.
Sample-adding Insufficient cleaning fluid in
2-606 "Mechanical Motion Check".
stop level cleaning tank
appears.
Timeout of reset of data "Mechanical Motion Check".
2-650 Stop level
acquisition board b. Please contact maintenance personnel if the
appears.
2-651 Caution level Dark count error

疗 a. Call out the system maintenance window,
医
appears.
Timeout of reset of data
2-700 Stop level acquisition temperature control
board
瑞
appears.
2-751 Caution level Pipeline air exhausting timeout
迪

appears.
2-752 Stop level Pipeline cleaning timeout
appears.
2-753 Stop level Pipe emptying timeout
appears.
Timeout of cleaning of waste "Mechanical Motion Check".
2-754 Stop level
liquid pipe b. Please contact maintenance personnel if the
appears.
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User manual

2-755 Stop level Timeout of probe cleaning
appears.
Reagent remaining volume scan "Mechanical Motion Check".
2-756 Stop level
timeout b. Please contact maintenance personnel if the
appears.
2-757 Stop level Vertical check timeout
appears.
a. Check whether the barcode is damaged.
b. Draw out the reagent rack with scanning
Scanning of channel barcode of error and re-scan the barcode.
2-888 Caution level
reagent rack 1 failed c. Please contact maintenance personnel if the
appears.
2-889 Caution level

reagent rack 2 failed 疗
Scanning of channel barcode of
error and re-scan the barcode.
医
appears.
2-890 Caution level
reagent rack 3 failed c. Please contact maintenance personnel if the
瑞
appears.
2-891 Caution level
sample rack 1 failed c. Please contact maintenance personnel if the
迪

appears.
2-892 Caution level
appears.
2-893 Caution level
appears.
2-894 Caution level
appears.
Sample-adding
2-895 No cuvette in the box a. Add cuvettes
stop level
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User manual

2-999 Procedure sequencing error
appears.
Z-axis motor of probe failed to
leave zero point
appears.
Zeroing of Z-axis motor of probe
failed
appears.
X-axis motor of probe failed to
leave zero point
appears.
Zeroing of X-axis motor of probe
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failed
appears.
Y-axis motor of probe failed to
leave zero point
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appears.
Zeroing of Y-axis motor of probe
failed
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appears.
Syringe pump motor failed to
leave zero point
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appears.
Zeroing of syringe pump motor
failed
appears.
Syringe motor failed to leave zero
point
appears.
3-12 Stop level Zeroing of syringe motor failed b. Please contact maintenance personnel if the
appears.
Checking of X-axis forward code
disk of probe failed
appears.
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User manual

Checking of X-axis reverse code
appears.
Checking of Y-axis forward code
appears.
Checking of Y-axis reverse code
appears.
3-18 Stop level Probe knocked b. Please contact maintenance personnel if the
appears.
Sample-adding Positioning of X axis of probe "Mechanical Motion Check".
3-19
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stop level failed b. Please contact maintenance personnel if the
appears.
Sample-adding Positioning of Y axis of probe "Mechanical Motion Check".
3-21
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appears.
Sample-adding Opening of solenoid valve V1 "Mechanical Motion Check".
瑞
3-23
appears.
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Sample-adding Closing of solenoid valve V1 "Mechanical Motion Check".

3-24
appears.
3-25
appears.
3-26
appears.
3-27
appears.
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User manual

3-28
appears.
3-29
appears.
3-30
appears.
3-31
appears.
3-32
Sample-adding
stop level
Closing of solenoid valve V5
failed 疗 a. Call out the system maintenance window,
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appears.
3-33
瑞
appears.
3-34
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appears.
3-35 Probe plugged
appears.
Sample-adding Error in sample dispensing "Mechanical Motion Check".
3-36
stop level parameters of syringe pump b. Please contact maintenance personnel if the
appears.
Probe control board and liquid
3-38 Caution level level detection control board
communication abnormal
appears.
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User manual

3-39 Heating failure of heating probe
appears.
Sample-adding
3-40 Inner wall detergent insufficient a.Add inner wall detergent
stop level
Sample-adding
3-41 Detergent insufficient a.Add diluent
stop level
Sample-adding Probe control board FLASH a.Power up the instrument again
3-42
stop level erasure failure b.Replace the probe control board
Sample-adding Syringe pump failed to suck pure "Mechanical Motion Check".
3-43
stop level water b. Please contact maintenance personnel if the
appears.
Z-axis motor of gripper failed to
leave zero point
appears.
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Zeroing of Z-axis motor of gripper
failed
appears.
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Y-axis motor of gripper failed to
leave zero point
appears.
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Zeroing of Y-axis motor of gripper

failed
appears.
X-axis motor of gripper failed to
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leave zero point
appears.
Zeroing of X-axis motor of gripper
failed
appears.
Checking of X-axis motor forward
code disk of gripper failed
appears.
Checking of X-axis motor reverse
appears.
Checking of Y-axis motor forward
appears.
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User manual

Checking of Y-axis motor reverse
appears.
Positioning of X axis of gripper "Mechanical Motion Check".
4-50 Stop level
failed b. Please contact maintenance personnel if the
appears.
Positioning of Y axis of gripper "Mechanical Motion Check".
4-55 Stop level
failed b. Please contact maintenance personnel if the
appears.
4-60 Stop level Gripper failed to hold the cuvette
appears.
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Gripper failed to release the "Mechanical Motion Check".
4-61 Stop level
cuvette b. Please contact maintenance personnel if the
appears.
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a. Check whether the reagent mixing motor is
stuck
Reagent mixing motor's leaving please execute "Reset" first, and then execute
4-65 Caution level
zero failed "Mechanical Motion Check".
瑞

appears.
a. Check whether the reagent mixing motor is
stuck
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Reagent mixing motor zeoring please execute "Reset" first, and then execute
4-66 Caution level
failed "Mechanical Motion Check".
appears.
Clamping jaw's adding cuvette was "Mechanical Motion Check".
4-70 Caution level
skipped b. Please contact maintenance personnel if the
appears.
Sample-adding Clamping jaw control board a.Power up the instrument again
4-71
stop level FLASH erasure failed b.Replace the clamping jaw control board
Peltier cooling timeout, no
temperature drop after the test area
5-1 Caution level b. Please contact maintenance personnel if the
has been refrigerated for a period
of time.
appears.
Excessively high AD value of and execute "Reset".
5-4 Caution level temperature sensor in reagent b. Please contact maintenance personnel if the
collection chamber. fault cannot be eliminated or other fault
appears.
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User manual

Excessively low AD value of and execute "Reset".
5-5 Caution level temperature sensor in reagent b. Please contact maintenance personnel if the
collection chamber. fault cannot be eliminated or other fault
appears.
Reagent chamber cooling and execute "Reset".
5-6 Stop level abnormal, with excessive large b. Please contact maintenance personnel if the
Peltier current. fault cannot be eliminated or other fault
appears.
Reagent chamber cooling and execute "Reset".
5-7 Caution level abnormal, with excessive low b. Please contact maintenance personnel if the
Peltier current. fault cannot be eliminated or other fault
appears.
a. Ask the tester to add water to the tank after
the instrument is in standby state.
Sample-adding Insufficient water in pure water
5-8 and execute "Reset".
stop level tank.
appears.
a. Ask the tester to pour out waste liquid after
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the instrument is in standby state.
Sample-adding
5-9 Waste liquid tank filled and execute "Reset".
stop level
appears.
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Float of waste liquid tank floating
abnormally
appears.
a. Measure ambient temperature firstly.
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5-11 Caution level Too high ambient temperature
appears.
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a. Measure ambient temperature firstly.

5-12 Caution level Too low ambient temperature
appears.
High pure water temperature and
excessively high AD value.
appears.
Low pure water temperature and
excessively low AD value.
appears.
a. Ask the tester to add cleaning fluid to the
tank after the instrument is in standby state.
Sample-adding Insufficient cleaning fluid in
stop level cleaning tank.
appears.
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User manual

Pure water heating fault, the and execute "Reset".
5-17 Caution level temperature fails to rise after b. Please contact maintenance personnel if the
continuous heating for a period fault cannot be eliminated or other fault
appears.
a. Ask the tester to empty Waste box after the
instrument is in standby state..
Sample-adding The Waste box is too filled to add
stop level samples.
appears.
a. Check whether the Waste box is removed.
5-19 Stop level Waste box removed abnormally
appears.
Excessively high AD value of
environment temperature sensor
appears.
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Excessively low AD value of
environment temperature sensor
appears.
Sample-adding
5-22 Insufficient detergent on outer wall a. Add detergent on outer wall
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stop level
Receiving communication message and execute "Reset".
5-23 Caution level from liquid level detection board b. Please contact maintenance personnel if the
failed fault cannot be eliminated or other fault
appears.
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a. Close the cover.

5-28 Stop level Cover of the instrument opened
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appears.
a. Please operate it according to the
instructions.
Sample-adding Sample rack 1 drawn out during
stop level the test
appears.
instructions.
stop level the test
appears.
instructions.
stop level the test
appears.
11-18
User manual

instructions.
stop level the test
appears.
instructions.
Sample-adding Reagent rack 3 drawn out during
stop level the test
appears.
instructions.
Sample-adding Reagent rack 2 drawn out during
stop level the test
appears.
instructions.
5-35
Sample-adding
stop level the test
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Reagent rack 1 drawn out during
appears.
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instructions.
Sample-adding Feeding box 1 drawn out during
stop level the test
appears.
瑞

instructions.
Sample-adding Feeding box 2 drawn out during
stop level the test
迪

appears.
Open circuit of light source for test
channel 1
appears.
channel 2
appears.
channel 3
appears.
channel 4
appears.
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User manual

channel 5
appears.
channel 6
appears.
channel 7
appears.
channel 8
appears.
Error of dark current AD value of
photocell for test channel 1
疗
appears.
医
appears.
appears.
瑞

appears.
迪

appears.
appears.
appears.
appears.
AD value of photocell for test
channel 1 reached full range
appears.
11-20
User manual

appears.
appears.
appears.
appears.
疗
appears.
医
appears.
appears.
瑞
a. Check whether there is a foreign matter at

the test hole site.
8-25 Stop level and execute "Reset".
channel 1 beyond the normal range
迪

appears.
the test hole site.
appears.
the test hole site.
appears.
the test hole site.
appears.
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User manual

the test hole site.
appears.
the test hole site.
appears.
the test hole site.
appears.
the test hole site.
8-32 Stop level
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appears.
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Excessively high temperature of
the test area
appears.
瑞
Excessively low temperature of the

test area
appears.
Test area heating timeout, no and execute "Reset".
迪
12-4 Caution level temperature rise after the test area b. Please contact maintenance personnel if the
has been heated for some time fault cannot be eliminated or other fault
appears.
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User manual
Chapter 12 Transportation and storage
12.1 Transportation
The transportation of Analyzer is specified in the contract, during which fierce collision, rain and exposure to sun
shall be prevented; also the Analyzer shall not be placed together with corrosive materials.
(1)Ensure that the liquid in the syringe pump and other pipes is drained before transport.
(2)During all moving and transporting processes, the analyzer must be kept in an upright direction.
12.2 Storage
The packed Analyzer shall be stored in an indoor space that is clean, ventilated and free of chemicals and corrosive
gas, and with ambient temperature of -40℃~55℃ and relative humidity of no more than 93%.
(1)Avoid direct sunlight in the storage process.
(2)During storage, ensure that the liquid in the analyzer syringe pump and other pipes is drained.
(3)Ensure that the analyzer is in an upright direction during storage.
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User manual
Appendix A Warranty
Dear users,
Thanks for using Automatic Blood Coagulation Analyzer (model: BCA-1000). Our company offers the following
services:
(1)Technical consultation at any time
(2)One-year free warranty for the complete machine from the date of purchase; and free repair service for any fault
caused due to design/manufacturing defects within the warranty period
(3)Paid services in the following cases:
a)The product out of warranty
b)Product damage due to an accident or improper use
c)Product damage due to non-compliance with the User Manual
d)Product damage due to repair without permission of our company
(4)With the development of technologies, our company will also provide update service of the Analyzer.
Please contact us according to the following information:

After-Sales Service From: DIRUI INDUSTRIAL CO., LTD.
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Address: 3333 Yiju Road, New & High Tech. Development Zone Changchun, Jilin 130103, the People’s Republic
of China
International Customer Service Hotline: +86 400 808 7597
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International Customer Service E-mail: service@dirui.com.cn
Domestic Customer Service Hotline: 400 811 6695 400 811 6605
Domestic Fax: 0431-85100405
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Domestic Customer Service E-mail: service.ch@dirui.com.cn

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User manual
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User manual
Appendix B Product Description
B.1 Product classification

According to the classified catalog for medical instrument products, Automatic Blood Coagulation Analyzer (model:
BCA-1000) is a blood analyzer belonging to clinical analyzers (6840), and the management class is Class II.
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医
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User manual
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医
瑞
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User manual
Appendix C Use instructions of LIS network interface (version No. V1.04)
Forward
Please read and understand the interface manual carefully before to ensure correct user of the system.
The objects of the use instructions are the personnel who develop LIS (laboratory information system) and other
personnel who need understand the HL7 interface. The interface manual is used to guide the developer to develop
the LIS interface to realize the communication between the LIS and the Analyzer system. The developing personnel
shall master the knowledge of LIS&HL7 standards and network programming abilities. The communication
protocol for network layer is TCP/IP and for application layer is HL7, and the version is 2.3.1. It is suggested to use
Visual C++, Delphi and other development tools on Windows platform.
1. Summary of interface
HL7 is the standard health information transmission agreement, and the agreement for electronic transmission
between different medical applications. HL7 integrates the interface standard formats of the application software of
different manufacturers, and it allows the data interaction among heterogeneous systems of different mechanism
institutes. The concept is defined in America firstly, and now it is accepted in many other countries.
The data transmission format of the interface is established based on HL7 version of 2.3.1.
1.1 HL7 message structure
In the HL7 communication protocol, the Message is the basic unit for exchange between data and system, and each
疗
message, with its own type, is used to define the trigger event of message type of the message category. A message
consists of several segments and each segment is provided with a name to define it contents and function. A segment
consists of several data fields. The first segment of a message is the message head segment which shows the
program name, message type and the only message ID number for sending and reception, and the composition of the
医
following segments is determined by the message type. For example, the PID (Patient Identification Data)
comprises the name, address and social insurance number. A data segment may consist of several elements. Some
messages are further classified according to the event code.
The interface is defined based on HL7v2.3.1, with details shown in HL7 Interface Standards Version 2.3.1.
1.2 HL7 underlying protocol
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TCP/IP is a byte stream protocol which does not provide the message boundary. HL7, the upper layer protocol, is
based on the information, however, it does not provide message termination mechanism. To determine the message
boundary, we use the minimal underlying protocol (described in HL7 Interface Standards Version 2.3.1). The
message starts with a single character and ends with two characters.
迪
The message is sent by the following format:

<SB> data <EB><CR>,
Including:
<SB> = Start Block character (1 wide char), ASCII <VT>, namely, 0x0B.
data = Data (variable number of wide chars), data is the HL7 message that only includes ISO 8859-1 character
(hexadecimal value 20 - FF) and <CR>, excluding other control characters and those cannot be printed.
<EB> = End Block character (1 wide char), ASCII <FS>, namely, 0x1C.
<CR> = Carriage Return (1 wide char), ASCII CR, namely, 0x0D.
Note: the protocol uses Unicode coding, and all character strings for sending and receiving are under Unicode
format.
2. Communication format
The interface communication includes the testing result transmission and sample information application. The
testing result transmission is mainly targeted to make the Analyzer to transfer its sample information, testing results
and QC results to the external system (like LIS). The data transmission modes include the real-time transmission
during testing and bulk transmission of historical results. The sample information application refers that the
Analyzer gets sample information from LIS to local for testing.
2.1 Support HL7 message
The HL7 message of the interface includes ORU, ACK, QRY, and DSR.
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User manual
The uploading diagram of the testing results is as follows:
The process diagram to obtain sample application information from LIS server is as below:
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ORU/ACK: non-request observation report/response. ORU^R01 message is mainly used to transmit the laboratory
result in HL7. We use it to transmit sample information, testing result and QC result to LIS.
The transmission information and testing results are:
Patient information (name, sample No., etc.)
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Doctor’s advice (sample type, sending doctor, check doctor, clinical diagnosis, etc.)
Check result
It is a group of messages where each message is related to a sample message (there may exist the testing results of
many items). LIS system can select and use the message as per the demand. In the below is the specific structure:
瑞
ORU Observational Results (Unsolicited) Description

MSH Message header
PID Patient information
迪
OBR Observation report

{OBX} Test result
The transmission testing results include the following information:

Item information (item No. and name)
QC liquid information (QC times, name, and batch No., etc.)
QC date and testing result
A message will send a QC test. The sending structure of QC results is as follows:
MSH Message header
OBR QC observation report
ACK^R01: the response of message to ORU. In the below is the specific structure:

MSH Message header
MSA Message confirmation
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User manual
QRY/QCK: inquire the observation result/response. QRY^Q02 message inquires the current date to get the sample
information for LIS system. It has the following structure:
QRY Query Description
MSH Message header
QRD Query definition
QRF Query filter
DSR/ACK: response to QRY message, and the display/response to the observation result. DSR^Q03 message is
used to response the QRY message on the one hand, and on the other hand, it is used to send and display the query
results, or let the LIS send the sample information to the Analyzer. The specific structure is as below:
DSR Display Response Description
MSH Message header
MSA Message confirmation
{DSP} Display data
ACK^Q03: the response of message to DSR message. The specific structure is as below:
ACK Acknowledgment Description
2.2 Message segment

MSH
MSA
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Message header
Message confirmation
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This section introduces all domains of the message segment in detail. Among them the serial number followed by
#is the required field of HL7. We will not omit the unused fields of the message segment for the purpose of
expanding in the future.
2.2.1MSH Message Header
The first message segment, and all segments of HL7 message is started with MSH segment. The segment is used to
瑞
define the concept, origin, purpose and some grammatical details of the message.
The MSH segment of the interface includes the following domains:
S/N Field name Length Description
迪
The separator between the segment ID and the first real

1# Field Separator 1 domain, and the separator for defining the residual
domains of the message (|).
Component separator, repetition separator, escaping
2# Encoding Characters 4
separator, and sub-component separator (^~\&).
3 Sending Application 180 Application program of delivering end.
4 Sending Facility 180 Blank and remained. Equipment of delivery end.
5 Receiving Application 180 Application program of receiving end.
6 Receiving Facility 180 Blank and remained. Equipment of receiving end.
Time of current message. To call the time information of
7 Date/Time Of Message 26
the system.
8 Security 40 Blank and remained. Safety
9# Message Type 7 Message type, like ORU^R01.
Message control ID, with only one mark of a message,
10# Message Control ID 20 increasing from 1 along with the increase of number of
the messages.
11# Processing ID 3 Handling ID, generally the P (refers to the product).
12# Version ID 60 Version ID, HL7 protocol version: . 2.3.1
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S/N Field name Length Description

13 Sequence Number 15 Blank and remained. Serial number.
14 Continuation Pointer 180 Blank and remained. Continuous pointer.
15 Accept Acknowledgment Type 2 Blank and remained. Reception and responding mode.
The responding mode of application program is regarded
as the result mode for sending. 0-patient sample testing
16 Application Acknowledgment Type 2 result; 1-calibration result; 2-QC result;
Wherein, the “1-calibration result” is temporarily not
supported.
17 Country Code 2 Blank and remained. Country code.
18 Character Set 10 Character set, taken as UNICODE.
19 Principal Language Of Message 60 Blank and remained. Major language of message.
Alternate Character Set Handling Blank and remained. Handling scheme of alternative
20 20
Scheme character set.
Note: the segment will appear in all messages. For the HL7 message sent from LIS system to the Analyzer, the value
of fields 3 & 4 of the segment are specified by the LIS developer while the fields 5 & 6 are set by the users on the
Analyzer software. The fields 10 & 16 are integers, and other fields are set as character strings.
2.2.2 MSA - message acknowledgment segment
The MSH segment of the interface includes the following domains:
S/N
1#
Field name
Acknowledgment Code
Length
2 疗 Description
Confirmation code, AA means accepted, AE means error, AR
means rejected, OK means data found, and NF means no data
found. OK and NF are only effective under the mode of DSR^Q03.
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2# Message Control ID 20 The message control ID is same to the MSH-10 of the sender.
The test message is the textual description of event in case of error
3 Text Message 80
or rejection. Relative to the field 6, and used to write the error log.
4 Expected Sequence Number 15 Blank and remained. Expected serial number.
瑞
Delayed Acknowledgment
5 1 Blank and remained. Delayed confirmation mode.
Type
6 Error Condition 100 Error condition (status code).
The value of MSA-6 field is shown in the table below:

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Status code (MSA-6) Status text (MSA-3) Description/Remark

Succeeded AA
0 Message accepted Succeeded
Query succeeded OK
0 Data found, not errors Query succeeded.
No data found after
NF
inquiry
0 No data found, not errors No data found after inquiry.
Error status code AE
Sequence of middle message segment is incorrect or
100 Segment sequence error
necessary fields are missing.
101 Required field missing Necessary fields in a segment are missing.
Field data type error, like the figure is written in
102 Data type error
character.
103 Table value not found Tabular value not found, not used temporarily.
Status code rejected AR
200 Unsupported message type Message type nonsupport.
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Status code (MSA-6) Status text (MSA-3) Description/Remark

201 Unsupported event code Event code nonsupport.
202 Unsupported processing id Handling ID nonsupport.
203 Unsupported version id Version ID nonsupport.
Unclear keyword mark, like transmitting the information
204 Unknown key identifier
of a nonexistent patient.
205 Duplicate key identifier Existing repeated keyword.
Affair cannot be executed in application program storage
206 Application record locked
level, like database being locked.
207 Application internal error Other unknown internal error of application.
Note: the message segment may appear in ACK^R01, DSR^Q03 and ACK^Q03. The fields 4 & 6 are integers, and other
fields are set as character strings.
2.2.3. PID Patient Identification
PID segment is mainly used to construct the patient information. The PID segment of the interface includes the following
domains:
S/N Field Length Description

1 Set ID – PID 10 Determine the message segment of different patients.
2
3#
4
Patient ID
Patient Identifier List
Alternate Patient ID – PID
20
16
10
Case No.
Bed No. 疗
Blank and remained. Admission number of patient.
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5# Patient Name 30 Patient name.
Section and ward. The section and ward are separated by ^; the
6 Mother’s Maiden Name 61
length for section is 30, and for ward is 30.
7 Date/Time of Birth 26 Blank and remained. Date of birth
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8 Sex 1 For sex, the male is sent as M, female as F, and others as O.

9 Patient Alias 48 Blank and remained. Blood type.
10 Race 80 Blank and remained. Blank and remained. Race.
11 Patient Address 106 Blank and remained. Address of patient.
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12 County Code 4 Blank and remained. County code (post code).

13 Phone Number -Home 40 Blank and remained. Phone number.
14 Phone Number -Business 40 Blank and remained. Blank and remained. Tel-company.
15 Primary Language 60 Blank and remained. Blank and remained. Primary language.
16 Marital Status 80 Blank and remained. Blank and remained. Marital status.
17 Religion 80 Blank and remained. Blank and remained. Religion.
18 Patient Account Number 30 Patient category.
19 SSN Number -Patient 16 Blank and remained. Number of medical insurance account.
Driver’s License Number –
20 25 Blank and remained. Charge type
Patient
21 Mother’s Identifier 20 Blank and remained. Mother identifier.
22 Ethnic Group 30 Nationality
23 Birth Place 60 Blank and remained. Birthplace.
Blank and remained. Blank and remained. Multiple birth mark, Y
24 Multiple Birth Indicator 1
stands for yes, and N for no.
25 Birth Order 2 Blank and remained. Birth order, integer larger than 0.
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26 Citizenship 100 Remarks.
27 Veterans Military Status 60 Blank and remained. Veteran status
28 Nationality 80 Blank and remained. Country.
29 Patient Death Date and Time 26 Blank and remained. Time of death.
30 Patient Death Indicator 1 Blank and remained. Death mark, Y stands for yes, and N for no.
Age and age unit. The age and age unit are separated by ^. The age is
an integer with length of 3. The age unit is a character string with
31 Patient Age 5
length of 1. Y stands for year, M for month, D for day, and H for
hour.
Note: the message segment is only suitable for ORU^R01. The age field 1, 25 and 31 are integers, and other fields are set
as character strings.
2.2.4. OBR Observation Request
OBR is used to transmit the doctor’s advice on the test report. When the patient sample testing result information
(MSH-16 set as 0) is transmitted, the interface has the following domains at OBR segment:

1 Set ID – OBR 10 Determine different OBR fields.
Number of doctor’s advice of the requester, used as the sample barcode
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2 Placer Order Number 22
No.
3 Filler Order Number 5 Number of doctor’s advice of the executor, used as the sample No.
4# Universal Service ID 200 Common service identifier.
5 Priority 2 Emergency treatment or no, Y stands for yes, and N for no.
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6 Requested Date/time 26 Blank and remained. Request time/date.
7 Observation Date/Time 26 Observation date/time, used as the check date/time.
8 Observation End Date/Time 26 Blank and remained. Observation end date/time.
瑞
9 Collection Volume 3 Used as the repeated testing times, setting as 1.

Collector identifier. Used as the sample and position. The sample rack
10 Collector Identifier 8 and position unit are separated by ^. The sample rack is 4 and the
position is 3 in length.
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11 Specimen Action Code 1 Blank and remained. Sample handling code.

12 Danger Code 1 Dangerous code. Used for dilution or no, Y stands for yes, and N for no.
Relevant clinical information, used as the clinical diagnosing
13 Relevant Clinical Info. 100
information of patients.
Specimen Received
14 26 Sending date/time.
Date/Time
Sample source, used as the sample type like serum, plasma and urine.
15 Specimen Source 1 0-serum, 1-urine, 2-plasma, 3-cerebrospinal fluid, 4-gastric juice,
5-ascites, 6-others, 7-whole-blood.
16 Ordering Provider 30 Provider of doctor’s advice, used by the sending doctor.
17 Order Callback Phone Number 30 Used by the Sending Department.
Blank and remained. Sample property (icterus, hemolysis, and
18 Placer Field 1 60
lipoidemia).
19 Placer Field 2 60 Blank and remained. No. of blood bag.
20 Filler Field 1 30 Attending doctor, used by the sending doctor.
21 Filler Field 2 60 Blank and remained. Department.
Result Rpt/Status Change –
22 26 Result report date/time.
Date/Time
23 Charge to Practice 40 Blank and remained. Charges.
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24 Diagnostic Serv Sect ID 10 Blank and remained. Diagnosis ID.
25 Result Status 1 Blank and remained. Result status.
26 Parent Result 200 Blank and remained. Father doctor’s advice result.
27 Quantity/Timing 200 Blank and remained. Quantity/time.
28 Result Copies To 150 Blank and remained. Result copy.
29 Parent 150 Blank and remained. Father doctor’s advice.
30 Transportation Mode 20 Blank and remained. Transmission mode.
31 Reason for Study 300 Blank and remained. Study of cause.
32 Principal Result Interpreter 30 Key interpreter of results, used by the reviewing doctor.
33 Assistant Result Interpreter 200 Blank and remained. Assistant interpreter of results.
34 Technician 200 Blank and remained. Technician.
35 Transcriptionist 200 Blank and remained. Transcription.
36 Scheduled Date/Time 26 Blank and remained. Planned date/time.
37 Number of Sample Containers 4 Blank and remained. Number of sample vessels.
38
39
40
Transport Logistics of
Collected Sample
Collector’s Comment
Transport Arrangement
Responsibility
60
200
60
疗
Blank and remained. Transport logistics of collected samples.
Blank and remained. Note to the collector.
Blank and remained. Arrangement and responsibility of transport.

医
41 Transport Arranged 30 Blank and remained. Transport prepared or not.
42 Escort Required 1 Blank and remained. Escort required.
Planned Patient Transport
43 200 Blank and remained. Comment to the transport arrangement of patients.
Comment
瑞
44 Ordering Facility Name 60 Blank and remained. Name of requester.

45 Ordering Facility Address 106 Blank and remained. Address of requester.
Ordering Facility Phone
46 48 Blank and remained. Tel of requester.
Number
迪
47 Ordering Provider Address 106 Blank and remained. Address of requester and provider.
Note: the message segment is only suitable for ORU^R01. The sample position fields 1, 3, 9 and 10 and fields 15 & 37 are
integers, and other fields are set as character strings.
If the item QC testing results (the result is 2 for MSH-16) is delivered, the definition of its field is as follows:

1 Set ID – OBR 10 Determine different OBR fields.
Number of doctor’s advice of the requester, used as the sample
2 Placer Order Number 22
barcode No.
3 Filler Order Number 5 Number of doctor’s advice of the executor, used as the sample No.
4# Universal Service ID 200 Common service identifier.
5 Priority 2 Emergency treatment or no, Y stands for yes, and N for no.
6 Requested Date/time 26 Blank and remained. Request time/date.
7 Observation Date/Time 26 Observation date/time, used as the QC date/time.
8 Observation End Date/Time 26 Blank and remained. Observation end date/time.
9 Collection Volume 20 Blank and remained.
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User manual

Collector identifier. Used as the sample rack and position. The
10 Collector Identifier 8 sample rack and position unit are separated by ^.
The sample rack is 4 and the position is 3 in length.
11 Specimen Action Code 5 Used as QC number.
Used for marking the module and inner/outer ring. The module and
12 Danger Code 3 inner/outer ring are separated by ^. Wherein 1 stands for outer ring,
2 for inner ring, 3 for inner/outer ring.
13 Relevant Clinical Info. 20 Used as QC name.
14 Specimen Received Date/Time 26 Blank and remained.
Sample source, used as the sample type like serum, plasma and
15 Specimen Source 1 urine. 0-serum, 1-urine, 2-plasma, 3-cerebrospinal fluid, 4-gastric
juice, 5-ascites, 6-others, 7-whole-blood.
16 Ordering Provider 15 Used as QC lot No.
17 Order Callback Phone Number 10 Used as the mean value.
18 Placer Field 1 10 Used as the standard deviation.
19 Placer Field 2 10 Used as QC result.
20 Filler Field 1 12 Used as QC result unit.
Used as result mark.
21 Filler Field 2 10
疗
If the difference between the absolute values of the result and the
mean is larger than or equal to SD and less than 2SD, return to +1SD
(or -1SD);
mean is larger than or equal to 2SD and less than 3SD, return to
医
+2SD (or -2SD);
mean is larger than or equal to 3SD, return to +3SD (or -3SD).
Result Rpt/Status Change –
22 26 Blank and remained. Result report date/time.
Date/Time
Used as QC rules.
瑞
mean is larger than or equal to SD and less than 2SD, return to
blank;
23 Charge to Practice 10 If the difference between the absolute values of the result and the
mean is larger than or equal to 2SD and less than 3SD, return to
1-2s;
迪
mean is larger than or equal to 3SD, return to 1-3s.
24 Diagnostic Serv Sect ID 10 Blank and remained. Diagnosis ID.
25 Result Status 1 Blank and remained. Result status.
26 Parent Result 200 Blank and remained. Father doctor’s advice result.
27 Quantity/Timing 200 Blank and remained. Quantity/time.
28 Result Copies To 150 Blank and remained. Result copy.
29 Parent 150 Blank and remained. Father doctor’s advice.
30 Transportation Mode 20 Blank and remained. Transmission mode.
31 Reason for Study 300 Blank and remained. Study of cause.
32 Principal Result Interpreter 30 Blank and remained. Key interpreter of results.
33 Assistant Result Interpreter 200 Blank and remained. Assistant interpreter of results.
34 Technician 200 Blank and remained. Technician.
35 Transcriptionist 200 Blank and remained. Transcription.
36 Scheduled Date/Time 26 Blank and remained. Planned date/time.
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User manual

37 Number of Sample Containers 4 Blank and remained. Number of sample vessels.
Transport Logistics of Collected
38 60 Blank and remained. Transport logistics of collected samples.
Sample
39 Collector’s Comment 200 Blank and remained. Note to the collector.
Transport Arrangement
40 60 Blank and remained. Arrangement and responsibility of transport.
Responsibility
41 Transport Arranged 30 Blank and remained. Transport prepared or not.
42 Escort Required 1 Blank and remained. Escort required.
Planned Patient Transport Blank and remained. Comment to the transport arrangement of
43 200
Comment patients.
44 Ordering Facility Name 60 Blank and remained. Name of requester.
45 Ordering Facility Address 106 Blank and remained. Address of requester.
46 Ordering Facility Phone Number 48 Blank and remained. Tel of requester.
47 Ordering Provider Address 106 Blank and remained. Address of requester and provider.
Note: the message segment is only suitable for ORU^R01. The sample position fields 1 & 10, module fields and
inner/outer marking fields 11 & 12, and the field 15 are integers; the fields 17, 18 and 19 are floating numbers; and
other fields are set as character strings.
2.2.5. OBX Observation
疗
OBX is mainly used to transfer the observation information in the report message. If the sample information (the
result is 0 for MSH-16) is delivered, there may be several OBXs for one patient. The OBX segment of the interface
includes the following domains:
医
1 Set ID – OBX 10 Determine different OBX fields.
For the type of values, NM (numeric), used for marking the type of
2 Value Type 3 testing results, refers to the numerical value; and ST (string) is used
瑞
for the quantitative items.

3# Observation Identifier 5 Observation identifier, used as the item ID No.
Observation Sub-ID, used as the item name and repeated testing
4 Observation Sub-ID 16 times. The item name and repeated testing times are separated by ^,
迪
with the length of 12 and 3 respectively.

Observation value, used as the testing result value (result
5 Observation Value 16
concentration, or negative & positive).
6 Units 12 Unit, used for the testing result value.
7 References Range 30 Reference range, the normal range of the testing result value.
Abnormal mark, representing whether the testing result is normal
8 Abnormal Flags 5
(by describing) L-lower, H-higher, N-normal.
9 Probability 5 Blank and remained. Possibility.
Blank and remained. Used as result mark. F-test result, C-recheck
10 Nature of Abnormal Test 5
result.
11# Observe Result Status 1 Blank and remained. Status of observation result.
Date Last Observe Normal
12 26 Blank and remained. Date of the final normal observation value.
Values
13 User Defined Access Checks 16 User discretionary access check, used as the original check.
14 Date/Time of the Observation 28 Observation date/time, used as the detection date/time.
15 Producer’s ID 30 Result generator ID
16 Responsible Observer 30 Observer, used by the sending doctor.
17 Observation Method 60 Blank and remained. Observation method.
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User manual
Note: the message segment only appears in ORU^R01. The repeated detection fields 1, 3 and 4 are integers; the
fields 5 & 13 are floating numbers; and other fields are set as character strings.
2.2.6. QRD - query definition segment
The OBX segment of the interface includes the following domains:
1# Query Date/Time 26 The query time is subject to the system time.
Query format code and method is set as SN (refers to sample
2# Query Format Code 2
numbering method and BC (refers to sample barcode method).
3# Query Priority 1 Query priority, set as D (deferred).
Query ID, referring to different queries, increasing from 1 along with
4# Query ID 10
the query numbers.
5 Deferred Response Type 1 Blank and remained. Delayed response type.
6 Deferred Response Date/Time 26 Blank and remained. Delayed response date/time.
7# Quantity Limited Request 10 Quantity limit rules, set as RD (Records).
Inquirer filtering symbol, if QRD-2 is the SN, the field is used as the
8# Who Subject Filter 30 sample No.; if QRD-2 is the BC, the field is used as the sample
barcode.
9# What Subject Filter 60 Blank and remained. Query content filtering symbol.
疗
Used as the sample rack and position. The sample rack and position
unit are separated by ^. The sample rack is 4 and the position is 3 in
10# What Department Data Code 8 length.
The sample rack and position should be set to ensure LIS returning at
the original value in DSR^Q03.
Used for dilution or no, Y stands for yes, and N for no. Dilution or
医
11 What Data Code Value Qual. 1
not to be returned by LIS in DSR^Q03 message at the original value.
12 Query Results Level 1 Blank and remained. Query result level, set as T (Full results)
Note: the message segment only appears in QRY^Q02. The field 4 is integer, and other fields are set as character
strings.
瑞
2.2.7. QRF - query filter segment

QRF segment is used together with QRD segment to further refine the original query. The QRF segment of the
interface includes the following domains:
迪

1# Where Subject Filter 20 Querier address filtering symbol.
Record starting date/time, used for beginning of the query sample
2 When Data Start Date/Time 26
receiving time.
Record ending date/time, used for ending of the query sample
3 When Data End Date/Time 26
receiving time.
4 What User Qualifier 60 Blank and remained. User conformity mark.
5 Other QRY Subject Filter 60 Blank and remained. Other QRF reception filtering symbol.
6 Which Date/Time Qualifier 12 Target type, RCT.
Which Date/Time Status
7 12 Target status, COR.
Qualifier
8 Date/Time Selection Qualifier 12 Date/time selection limit symbol, ALL.
When Quantity/Timing
9 60 Blank and remained. Time interval segment.
Qualifier
Note: the message segment only appears in QRY^Q02. The fields 3 & 4 are to inquire the zero point of current day
and the time of occurrence respectively to set as the time section condition of query. All fields are set as character
strings.
2.2.8. DSP - display data segment
DSP segment is used to give the sample information and detection items of the query, and it is allowed to be
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User manual
repeated. DSP is repeated for 3 times; the first DSP delivers the patient information where the following domains
are used:
1 Set ID - DSP 4 Determine different DSP segments.
The detailed items are same
2 - 31 to that of PID-2 to PID-31 of See details in description of PID segment.
DSP segments.
Note: the message segment only appears in DSR^Q03. The first field is integer while others are detailed in the
description of PID-2~PID-31.
The second DSP delivers the doctor’s advice information where the following domains are used:
1 Set ID - DSP 4 Determine different DSP segments.
The detailed items are same to that of
2 - 47 See details in description of OBR segment.
OBR-2 to OBR-47 of OBR segments.
Note: the message segment only appears in DSR^Q03. The first field is integer while others are detailed in the description
of OBR-2~OBR-47.
The third DSP delivers the item information whose detailed items and sequence is shown in the table below:
S/N
1
2
Set ID - DSP
Item Count
Field Length
4
4
疗 Description
Determine different DSP segments.
Number of detection items.
Name of detection items. The detection items are separated by ^
医
3 Items 1000 like ALT^ALB^T4&5 and set as character strings. The
immunization items is expressed with a suffix of “&5”.
Note: the message segment only appears in DSR^Q03. The fields 1 & 2 are integers, and other fields are set as
character strings.
瑞
3. Communication examples
3.1 Process of sending detection data
The Analyzer sends the sample information and testing results to LIS server in the unit of sample, namely, a sample
and the detection results are set as a message for sending. LIS server will give response after judging the message.
迪
Wherein, ORU message includes the segments of MSH, PID, OBR and OBX (if a sample contains several items,
there will be several OBX segments). The MSH is the head segment of messages and shall be included in any
message.
Assuming there is a patient with the information shown in the table below:
Meaning of field Value
Patient name Jack
Case No. 002
Sex Male
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User manual

Sending date On March 21, 2011
Sending time At 10:11:12
Sample barcode 12345
Sample type Serum
Sample No. 10
ER or not Yes
Sample rack No. and position E002,3
Age Two years old
Item No. 1,2,3
Item name ALT, AST, T4
Test repeating times 1,1,1
Test result 2.3, 35, 2.1
Result unit U/L, U/L, mol/L
Reference range 0-40, 0-34, 2.82-8.2
The ORU^R01 message sent to LIS server is:
疗
医
瑞
迪
After receiving the message, LIS server will give response after judging the validity and type of the message. In the
below is the response under normal condition:
If LIS server founds error of the received ORU message, the related error code will be set in the MSA segment and
returned, and the Analyzer software will conduct error treatment. For example, the LIS server tests an error with
code of 206 and rejects the error, the ACK message for response is:
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User manual
The Analyzer sends the QC testing results to LIS server and delivered it in the unit of a QC test. LIS server will give
response after judging the message. Wherein ORU message contains MSH and OBR segments.
Assuming there is a QC test with the information shown in the table below:
Item No. 1
Item name ALT
QC name Landau low value
QC lot No. 123
QC times
Module number
Sample type 疗
1
1
Serum
医
Sample rack and position C001,2
QC mean value 40
QC standard deviation 1
Testing result value (concentration) 123.232
瑞
Detection date/time 2011.03.21 16:46:43
The ORU^R01 message sent to LIS server is:

迪
LIS server gives the response as follows:
3.2 Process of sending query request

The Analyzer sends the query request to the LIS server and obtains the corresponding information of sample, patient
and item as per the specified barcode.
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User manual
For example, if to inquire and download a sample with barcode number of 12345, sample rack of N003, position of
4, and under non-diluted condition, from LIS server, the QRY^Q02 message is:
疗
医
LIS server will response with a DSR^Q03 message after receiving the message, and the sample of response is as
follows:
瑞
迪
If LIS server does not have the samples, the return message is:
If LIS server founds error of the received QRY message, for example, the LIS server tests an error with code of 206
and rejects the error, the response message is:
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User manual
After receiving DSR message, the Analyzer will send ACK^Q03 as response confirmation, and the return message
is:
For example, if to inquire and download a sample with sample number of 5, sample rack of N003, position of 4, and
under non-diluted condition, from LIS server, the QRY^Q02 message is:
疗
医
LIS server will response with a DSR^Q03 message after receiving the message, and the sample of response is as
follows:
瑞
迪
After receiving DSR message, the Analyzer will send ACK^Q03 as response confirmation, and the return message
is:
Note: during sending the request, the Analyzer includes the sample rack, sample position, dilution information in the
QRD segment of QRY^Q02 message and sends to LIS, and LIS server needs to include the original values of the
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User manual
three segments in DSP segment and return the DSR^Q03 message.
疗
医
瑞
迪
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User manual
Appendix D Parts List
Parts List (including parts, accessories and consumables)

Replacement Replacement
Part name Location Remarks
cycle method
Please contact This part can be
Appropriate
Waste liquid pump Liquid tube unit customer service checked/replaced by the
time
staff. manufacturer/agency only.

Reagent chamber Appropriate
Peltier customer service checked/replaced by the
unit time

Appropriate
Pressure sensor Liquid tube unit customer service checked/replaced by the
time

Probe syringe Appropriate
Liquid tube unit customer service checked/replaced by the
pump time
Printing paper, See operation Accessories (contact the

colored tape, ink
and toner cartridge
Sample cup
External printer
Sample chamber
Appropriate
time
Appropriate
time 疗
instructions of the
printer
manufacturer or seller of the
printer for replacement)
医
瑞
迪
D-1
User manual
疗
医
瑞
迪
D-2
User manual
Appendix E Performance Indexes
E.1 Preheating time

Preheating time after startup should be less than 30min.
E.2 Temperature control
E.2.1 Temperature of reaction system for the test part and thermostat at preheating position is controlled to be
37.0℃±1.0℃;
E.2.2 Temperature of reagent refrigeration position is kept not over 16.0℃.
E.3 See Table E-3-1 for test items and reporting unit.
Table E-3-1 Test Items and Reporting Unit
Test items Reporting unit

Prothrombin time (PT) Seconds (s), international normalized ratio (INR)
Activated partial thromboplastin time (APTT) Seconds(s)
Fibrinogen (FIB) g/L
Thrombin time (TT) Seconds(s)
Coagulation factor activity
E.4 Carry-over rate

E.4.1 Carry-over rate of sample 疗
U/Lor percentage (%)
医
FIB carry-over rate is ≤10.0%.
E.4.2 Carry-over rate of reagent
Carry-over rate of TT to PT is ≤5.0%.
E.5 Test speed
瑞
When the instrument testes PT only, test speed is 100 times/h.

E.6 Precision
E.6.1 PT precision
Coefficient of variation (CV) of normal sample test results is ≤2.0% (sample requirement 11s~14s); and CV of
迪
abnormal sample test results is ≤4.0%.

E.6.2 APTT precision
E.6.3 Fibrinogen (FIB) precision
Coefficient of variation (CV) of normal sample test results is ≤4.0% (sample requirement 2g/L~4g/L); and CV of
E.6.4 TT precision
E.7 Accuracy
Relative deviation of FIB is not greater than ±10.0%.
E.8 Linearity
FIB linear range [0.7～6.0）g/L, and linear correlation coefficient r≥0.99; allowable deviation range should meet the
requirements in Table E-8-1.
E-1
User manual
Table E-8-1 FIB Linear Requirements
Linear range Allowable deviation range
[0.7～2.0] g/L Not exceed ±0.2g/L
（2.0～6.0）g/L Not exceed ±10.0%
E.9 Consecutive work time

After the Analyzer is in a stable working state, test PT, APTT, TT, and FIB for normal samples; the allowable
deviation between the test results of the 8th hour and those at the initial time of the stable work state are shown in
Table E-9-1.
Table E-9-1
Test items Allowable deviation range

Prothrombin time (PT) Not exceed ±10.0%
Activated partial thromboplastin time (APTT) Not exceed ±8.0%
Fibrinogen (FIB) Not exceed ±8.0%
Thrombin time (TT) Not exceed ±8.0%
疗
医
瑞
迪
E-2
User manual
Appendix F Statement on Electromagnetic Compatibility
The analyzer shall comply with the requirements of IEC 61326-1 and IEC 61326-2-6. The requirements for the
electromagnetic compatibility emission test item shall be listed in Table F-1, and the requirements for
electromagnetic compatibility immunity shall be listed in Table F-2, F-3. This product has been tested for
electromagnetic compatibility and meets the standard requirements of “IEC 61326-2-6 Electrical equipment for
measurement, control and laboratory use—EMC requirements, Part 2-6: — In vitro diagnostic (IVD) medical
equipment” and “IEC 61326-1 Electrical equipment for measurement, control and laboratory use—EMC
requirements, Part 1: General requirements”.
The following application requirements shall be strictly observed during use; otherwise it may cause
electromagnetic interference to other devices or reduce the anti-electromagnetic interference capability of the
product, or even lose the basic performance.
This equipment is designed and tested according to Group 1 Class A equipment in IEC/CISPR 11. In a home
environment, this device may cause radio interference and precautions need to be taken.
Portable and mobile RF communications equipment may affect the description of medical electrical equipment:
Portable and mobile RF communications equipment may affect the normal operation of this product, and should
ensure that portable and mobile RF communications equipment and this product to meet specific spatial distance
requirements. See Table F-4 for the requirements.
Caution 1: In addition to the transducers and cables sold by manufacturers of equipment or systems as spare parts
increased emission or reduced immunity of the equipment or system.

疗
for internal components, the use of accessories, transducers, and cables other than those specified may result in
Caution 2: The equipment or system should not be used near or stacked with other equipment. If it must be
approached or stacked, it should be observed and verified that it can operate normally under its configuration.
医
Caution 3: It is forbidden to use this device beside strong radiation sources; otherwise it may interfere with the
normal operation of the device.
Table F-1 Guidance and Manufacturer’s Declaration — Electromagnetic Emission
瑞
Guidance and Manufacturer’s Declaration — Electromagnetic Emission
The product is expected to be used in the electromagnetic environment specified below, and the purchaser or user should
ensure that it is used in this electromagnetic environment
Emission Test Compliance Electromagnetic Environment — Guide

迪
RF Emission The product uses RF energy only for its internal functions. So its
Group 1 radio frequency emission is very low, and it is very unlikely that it
IEC/CISPR 11 will interfere with electronic equipment.
RF Emission
Class A
IEC/CISPR 11
Harmonic emission The product is not for domestic use, and suitable for all facilities of
Not applicable
IEC 61000-3-2 public low-voltage power supply networks which are not
connected directly for domestic use.
Voltage fluctuation /
flicker emission Not applicable
IEC 61000-3-3
F-1
User manual
Table F-2 Guidance and Manufacturer’s Declaration — Electromagnetic Emission
Guidance and Manufacturer’s Declaration — Electromagnetic Emission
The product is expected to be used in the electromagnetic environment specified below, and the purchaser or user should
ensure that it is used in this electromagnetic environment
IEC 61326-2-6 Electromagnetic Environment

Immunity Test Compliance Level
Test Level Guide — Guide
±2kV, ±4kV ±2kV, ±4kV The floor should be wood, concrete

Electrostatic or ceramic tile. If the floor is
contact discharge contact discharge
Discharge covered with synthetic material,
±2kV, ±4kV, ±8 kV ±2kV, ±4kV, ±8 kV air the relative humidity should be at
IEC 61000-4-2
Air discharge discharge least 30%.
Electrical Fast The network power should have

Transient the quality used in a typical
±1 kV to power cord ±1kV to power cord
commercial or hospital
IEC 61000-4-4 environment.
The network power should have

Surge ±1 kVwire to wire ±1 kVwire to wire the quality used in a typical
IEC 61000-4-5 ±2 kV line to ground ±2 kV line to ground commercial or hospital
Voltage sag, short

interruption, and
0%UT, lasting 1 cycle (at Ut,
100% sag)
40%UT, last 5 cycles (at Ut,
疗
0%UT, lasting 1 cycle
40%UT, lasting 5 cycles
environment.
The network power should have

the quality used in a typical
commercial or hospital
environment. If the user of the
医
60% sag) product needs continuous
voltage change on 70%UT, lasting 25
power input wire 70%UT, lasting 25 cycles (at operation during a power
cycles interruption, it’s recommended
Ut, 30% sag)
IEC 61000-4-11 5%UT, lasting 5s that the product be powered by an
5%UT, lasting 5s(at Ut, 95%
uninterruptible power supply or
sag)
battery.
瑞
If abnormal work occurs, it is

necessary to keep the product away
Power frequency from the power frequency
magnetic field magnetic field or install magnetic
3A/m 3A/m shields at the site. The power
迪
(50/60Hz)
frequency magnetic field within the
IEC 61000-4-8 intended installation site shall be
measured to meet the requirements
of lower than compliance level.
Note: UT refers to AC grid voltage before voltage is applied
F-2
User manual
Table F-3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The product is expected to be used in the electromagnetic environment specified below, and the purchaser or user should ensure
that it is used in this electromagnetic environment.
IEC 61326-2-6 Test Compliance

Immunity Test Electromagnetic Environment — Guide
Level Level
Portable and mobile RF communications equipment
should not be used near any part of the product
including cables; they should keep the recommended
isolation distance. The calculation of this distance
should use the formula corresponding to the
transmitter frequency.
Radiofrequency 3V(valid value) 3 V(valid Recommended isolation distance
Conduction value) d=1.2
150 kHz～80 MHz
IEC 61000-4-6
d=1.2 80 MHz～800 MHz
d=2.3 800 MHz～2.0 GHz
RF radiation
IEC 61000-4-3
3 V/m
80 MHz～2.0 GHz
3 V/m
疗 Where:
P —— the maximum output power rating of the
transmitter provided by the transmitter manufacturer
in watts (W);
d——recommended isolation distance in meters (m).
医
The field strength of a fixed RF transmitter is
determined by survey a of the electromagnetic field,
and each frequency range b should be lower than the
compliance level. Interference may occur near
equipment marked with the following symbol
瑞
Note 1: The formula for higher frequency bands should be used at frequencies of 80 MHz and 800 MHz.
Note 2: These guidelines may not be suitable for all situations. Electromagnetic transmission is affected by the absorption and
reflection of buildings, objects, and human bodies.
迪
a. As for fixed transmitters, such as: wireless (cellular/cordless) telephones and ground mobile radio base stations, amateur
radio, AM FM radio broadcasts, and television broadcasts, theoretically their field strengths cannot be accurately predicted. To
assess the electromagnetic environment of a fixed RF transmitter, the survey of the electromagnetic site should be considered.
If the measured field strength of the product is higher than the above RF compliance level, the product should be observed to
verify that it can operate normally. If abnormal performance is observed, supplemental measures may be necessary, such as
reorienting or positioning the product.
b. In the entire frequency range from 150 kHz to 80 MHz, the field strength should be less than 3 V/m.
F-3
User manual
Table F-4 Recommended Isolation Distance between Portable and Mobile RF Communications Equipment and Product
Recommended Isolation Distance between Portable and Mobile RF Communications Equipment and Product
The product is expected to be used in an electromagnetic environment where RF radiation disturbances are controlled.
Depending on the maximum output power of the communications device, the purchaser or user of the product can prevent
electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications
equipment (transmitter) and the product.
Isolation distance/m corresponding to the transmitter's different frequencies

Transmitter maximum
rated output power 150 KHz～80 MHz 80 MHz～800 MHz 800 MHz～2.0 GHz
W
d=1.2 d=1.2 d=2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For the maximum rated power of transmitters not listed in the above table, the isolation distance, d, in meters (m) is
recommended and can be determined using the formula in the corresponding transmitter frequency column, where P is
maximum rated output power in watts (W) of the transmitter provided by the transmitter manufacturer.
疗
Note 1: The formula for higher frequency bands should be used at frequencies of 80 MHz and 800 MHz.
Note 2: These guidelines may not be suitable for all situations. Electromagnetic transmission is affected by the absorption and
reflection of buildings, objects, and human bodies.
医
瑞
迪
F-4
迪
瑞
医
疗

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迪

Manufacturer: DIRUI INDUSTRIAL CO., LTD.

Place of Production: Changchun, China

Tel: 400 811 6695 400 811 6605

Complaints Hotline: 0431-81935326 85177245

Date of Production: See the label.

Service Life: 7 years

Compiled/Revised on: 09-2019

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

● Please do not use combustible goods around the Analyzer.

Dirui has the final interpretation right of the manual.

(2)Relevant electrical equipment complies with national standards.

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

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

2.2.1 Unpacking steps ................................................................................................................................................................ 2-2

2.3 Installation process ......................................................................................................................................... 2-9

3.3.1 Window composition ......................................................................................................................................................... 3-6

5.4 Printing setting .............................................................................................................................................. 5-10

5.6.1 System ............................................................................................................................................................................. 5-13

7.2.3 QC test............................................................................................................................................................................... 7-4

10.1 Preparation before system maintenance ................................................................................................... 10-1

10.2 Analyzer resetting ....................................................................................................................................... 10-1

10.5.1 Probe cleaning ............................................................................................................................................................... 10-9

Appendix B Product Description .................................................................................................. B-1

Appendix E Performance Indexes ................................................................................................ E-1

Chapter 1 Brief introduction

1.2 Major indicators

Reagent volume 20μL~175μL

Sample chamber, sample

Data system Computer configuration Optional computer and printer

Normal operating conditions of the Analyzer

1.3 Composition of the Analyzer

1.3.1.2 View of the Analyzer after the front door is opened

1 15mL reagent bottle rack

1.3.1.4 Top view of the Analyzer

Fig. 1-3-5 Left view of the Analyzer

1.3.1.6 Right view of the Analyzer

1 Network port 2 Power receptacle 3 Power switch 4 Power indicator lamp

1.3.2 System composition of the Analyzer

reclaiming unit Feeding

Fig. 1-3-7 System composition

1.4 Structure and functions of the Analyzer

1 Column 2 Base plate

Test tube: Φ12mm×75mm, Φ12mm×100mm, Φ13mm×75mm, Φ13mm×100mm(±1mm), Φ16mm×75mm(±1mm),

1.4.2.3 Reagent chamber unit

Reagent bottle name Reagent bottle size Adapter

Dirui 15mL reagent bottle Not needed

Reagent bottle name Reagent bottle size Adapter

Dirui 5mL reagent bottle

1 normal temperature reagent bottle rack 2 adapter 3 reagent bottle 15mL

Reagent bottle type Reagent bottle size Adapter

Dirui 50mL reagent bottle Not needed

Normal temperature reagent position adapter

Dirui 15mL reagent bottle

疗 Normal temperature reagent position adapter

then aspirate sample.

1.4.2.7 Feeding unit

1 Drawer at left side 2 Status check optocoupler 3 Base plate

Fig. 1-4-7 Liquid tube unit

(1)Composition and functions

LASER, DANGER SYMBOL

IN VITRO DIAGNOSTIC MEDICAL DEVICE

THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE ON IN VITRO DIAGNOSTIC

BCA-1000 用户手册英文 1041180 2019-09 C.1

BCA-1000 用户手册英文 1041180 2019-09 C.1