spincell3 - cromakit.es · note 1) carefullyreadthismanualbeforefirstoperation. 2)...

Spincell3

Automated Hematology Analyzer

Operation Manual

URIT Medical Electronic Co.,Ltd.

NOTE

1) Carefully read this manual before first operation.

2) Inspect the electrical requirements of the analyzer before power on,and properly connect the grounding wire.

3) Turn off the power and disconnect the power cord if the analyzer is idlefor a long time.

4) Do not run the analyzer if it’s in an abnormal or damaged condition.

5) There is potential biohazard of the reagents and samples; operatorshould follow proper biosafety practices. Dispose waste reagents andsamples in accordance with local, national regulations.

I

CONTENTSCopyright and Declaration....................................................................................................... I

Guidance..................................................................................................................................III

Chapter 1 System Description............................................................................................... 1

1.1 Overview..................................................................................................................... 11.1.1 Function........................................................................................................... 11.1.2 Intended Use...................................................................................................11.1.3 Front Panel......................................................................................................21.1.4 Rear Panel...................................................................................................... 6

1.2 Parameters................................................................................................................. 71.3 Structure......................................................................................................................8

1.3.1 Flow System....................................................................................................81.3.2 Electrical System............................................................................................81.3.3 Display............................................................................................................11

1.4 Accessory..................................................................................................................111.5 Sample Volume........................................................................................................111.6 Reagent Volume for Single Sample..................................................................... 121.7 Test Speed................................................................................................................ 121.8 Storage...................................................................................................................... 121.9 Background Test...................................................................................................... 121.10 Carryover................................................................................................................ 121.11 Accuracy..................................................................................................................121.12 Precision................................................................................................................. 131.13 Linearity...................................................................................................................131.14 Transport and Storage Specifications................................................................131.15 Environment Requirement...................................................................................141.16 Electrical Requirement......................................................................................... 141.17 Reagent...................................................................................................................14

1.17.1 Diluent..........................................................................................................141.17.2 Lyse.............................................................................................................. 151.17.3 Detergent.....................................................................................................151.17.4 Probe Detergent.........................................................................................151.17.5 Note of Reagent Use.................................................................................151.17.6 Reagent Storage.................................................................................... 16

Chapter 2 Principles of Operation....................................................................................... 17

2.1 Principles of Measuring.......................................................................................... 172.1.1 Electrical Impedance Method.....................................................................172.1.2 HGB Colorimetric Method...........................................................................18

2.2 Reagents Function.................................................................................................. 192.3 Calculation of Parameters......................................................................................19

Chapter 3 Installation and Specimen Analysis..................................................................22

Contents

II

3.1 Unpacking and Inspection......................................................................................223.2 Installation Requirements.......................................................................................223.3 Power Supply Inspection........................................................................................233.4 Tubing Installation....................................................................................................23

3.4.1 LYSE Tubing Installation............................................................................. 233.4.2 DILUENT Tubing Installation......................................................................243.4.3 WASTE Tubing Installation.........................................................................243.4.4 DETERGENT Tubing Installation.............................................................. 24

3.5 Printer Installation (optional)..................................................................................253.6 Keyboard and Mouse Installation......................................................................... 253.7 Power Connection................................................................................................... 253.8 Startup....................................................................................................................... 253.9 Background Test...................................................................................................... 263.10 Quality Control....................................................................................................... 273.11 Calibration...............................................................................................................273.12 Collection of Blood Sample................................................................................. 27

3.12.1 Venous Blood Collection...........................................................................283.12.2 Peripheral Blood Collection......................................................................28

3.13 Mode Switch...........................................................................................................283.14 Sample Counting and Analysis........................................................................... 28

3.14.1 Information Input........................................................................................ 293.14.2 Counting and Analysis.............................................................................. 303.14.3 Special Function.........................................................................................31

3.15 Result Analysis...................................................................................................... 323.16 Report Output.........................................................................................................333.17 Result Modification................................................................................................333.18 Shutdown................................................................................................................353.19 Data Query............................................................................................................. 35

3.19.1 Selection, Browse, Modification and Output of Data........................... 373.19.2 Data Deletion.............................................................................................. 383.19.3 Workload Statistics................................................................................ 39

3.20 Special Function.................................................................................................... 393.20.1 Precision Counting.....................................................................................393.20.1.1 Select Sample Results.......................................................................... 403.20.1.2 Check Precision......................................................................................403.20.2 Trend Graph................................................................................................41

Chapter 4 Soft Keyboard...................................................................................................... 45

4.1 Soft Keyboard Introduction.................................................................................... 454.2 Function.....................................................................................................................46

4.2.1 Data Edit........................................................................................................ 464.2.2 Condition Query............................................................................................474.2.3 Parameter Limit Setting.............................................................................. 484.2.4 L-J QC Edit....................................................................................................494.2.5 X-B QC Edit...................................................................................................50

Contents

III

4.2.6 X QC Edit.......................................................................................................514.2.7 Manual Calibration....................................................................................... 524.2.8 Automatic Calibration...................................................................................534.2.9 System Setting..............................................................................................544.2.10 Service......................................................................................................... 55

Chapter 5 System Setting.....................................................................................................57

5.1 System Maintenance.............................................................................................. 575.2 Transfer Setting........................................................................................................585.3 Print Setting.............................................................................................................. 595.4 Parameter Setting....................................................................................................605.5 Date/Time Setting....................................................................................................615.6 System Version........................................................................................................ 62

Chapter 6 Quality Control..................................................................................................... 63

6.1 Quality Control Options.......................................................................................... 636.2 QC Operation........................................................................................................... 64

6.2.1 QC Mode Select........................................................................................... 646.2.2 L-J QC............................................................................................................656.2.3 X QC...........................................................................................................70

6.2.4 X -R QC.......................................................................................................74

6.2.5 X-B QC...........................................................................................................78

Chapter 7 Calibration.............................................................................................................83

7.1 Preparation for Calibration..................................................................................... 847.2 Manual Calibration.................................................................................................. 857.3 Auto Calibration........................................................................................................86

Chapter 8 Parameter Limit....................................................................................................88

8.1 Limit Review............................................................................................................. 888.2 Limit Modification.....................................................................................................908.3 Print............................................................................................................................90

Chapter 9 Maintenance.........................................................................................................91

9.1 Daily Maintenance...................................................................................................919.2 Weekly Maintenance...............................................................................................92

9.2.1 Surface Maintenance...................................................................................929.3 Monthly Maintenance..............................................................................................939.4 System Maintenance.............................................................................................. 93

9.4.1 Cauterize Aperture....................................................................................... 949.4.2 Flush Aperture.............................................................................................. 949.4.3 Drain Cups.................................................................................................... 949.4.4 Rinse Cups....................................................................................................959.4.5 Rinse Fluidics................................................................................................959.4.6 Prime Lyse.....................................................................................................969.4.7 Prime Diluent................................................................................................ 97

Contents

IV

9.4.8 Prime Detergent........................................................................................... 979.4.9 Prime Fluidics............................................................................................... 989.4.10 Prepare Shipping....................................................................................... 98

9.5 Maintenance before Shipping................................................................................99

Chapter 10 Service.............................................................................................................. 101

10.1 System Check......................................................................................................10110.1.1 System Status Check..............................................................................10110.1.2 Valve Check.............................................................................................. 10210.1.3 Motor Check..............................................................................................104

10.2 System Log...........................................................................................................10510.2.1 System Log Query Mode........................................................................106

Chapter 11 Troubleshooting................................................................................................110

11.1 Troubleshooting Guidance................................................................................. 11011.2 Obtaining Technical Assistance.........................................................................11111.3 Troubleshooting....................................................................................................111

11.3.1 Faults Relate to Reagents...................................................................... 11211.3.2 Faults Relate to Vacuum.........................................................................11211.3.3 Faults Relate to 5V Voltage....................................................................11311.3.4 Faults Relate to Test Results................................................................. 11311.3.5 Faults Relate to Hardware...................................................................... 11411.3.6 Faults Relate to Temperature.................................................................115

Chapter 12 Precautions, Limitations and Hazards......................................................... 116

12.1 Limitations.............................................................................................................11612.2 Location Limitations............................................................................................ 11612.3 Personal Protection and Infection Control...................................................... 117

Appendix A: Instrument Specifications............................................................................. 119

Appendix B: Instrument Icons and Symbols....................................................................122

Appendix C: Communication..............................................................................................123

1. Hexadecimal Format Communication..........................................................................123

1.1 Data Link MAC Sublayer Parameters Convention.................................. 1231.2 Data Link Layer Frame Format........................................................................... 1231.2.1 Frame Format..................................................................................................... 1231.2.2 Meaning of Fields or Control Fields................................................................ 123

1.2.3 Convention.................................................................................................. 1241.3 Message Field Structure...................................................................................... 1242. ASCII Format Communication...............................................................................125

2.1 Message Transfer Format............................................................................1252.2 Massage Grammar....................................................................................... 1252.3 Data Type........................................................................................................1252.4 Message Type................................................................................................126

3 Communication Operations.....................................................................................131

I

Copyright and Declaration

Copyright © URIT Medical Electronic Co.,Ltd.

Declaration:All contents in this manual were strictly compiled according to related laws andregulations in local, as well as the specific condition of Spincell3 AutomatedHematology Analyzer, covering all the updated information before printing.URIT Medical Electronic Co.,Ltd. is fully responsible for the revision andexplanation of the manual, and reserves the right to renovate the relevantcontents without separate notification. Some of the demonstration pictures arefor reference and subject to real object if any differences.

All the information included is protected by copyright. No part of this documentmay be reproduced, stored or transmitted in any form or by any means unlesswritten authorization by URIT Medical Electronic Co.,Ltd..

All instructions must be followed strictly in operation. In no event should URITMedical Electronic Co.,Ltd. be responsible for failures, errors and otherliabilities resulting from user's noncompliance with the procedures andprecautions outlined herein.

Limited Responsibility for Quality Warranty:The manual for Spincell3 Automated Hematology Analyzer, defines the rightsand obligations between the manufacturer and the customers about theresponsibility for quality warranty and after-sales service, also the relatedagreements on commencement and termination.

URIT warrants the Spincell3 sold by the URIT and its authorized agents to befree from defects in workmanship and materials during normal use by theoriginal purchaser. This warranty shall continue for a period of one year sincethe date of installation. The instrument service life is 10 years.

Copyright and Declaration

II

URIT assumes no liability in the following situations even during the periodwarranty:1) Failure due to abuse the instrument or neglect the maintenance.2) Use reagents and accessories other than manufactured or recommended

by URIT.3) Failure due to the operation which is not under the instructions described

in the manual.4) Replace accessories which are not specified by URIT. Maintain or repair

the analyzer by a service agent who is not approved or authorized byURIT.

5) Components have been dismounted, stretched or readjusted.

CAUTION:THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE ONLY.

Technical service and troubleshooting are provided by the Service Departmentof URIT. Professional technician and sale representative will be sent to offeryou timely service when necessary.

URIT Medical Electronic Co.,Ltd.

No.4 East Alley, Jiuhua Road, Guilin, Guangxi 541001, PR ChinaTel: +86（773）2288586Fax: +86（773）2288560Web: www.urit.comEmail: [email protected]

Wellkang Ltd t/a Wellkang Tech ConsultingSuite B 29 Harley Street, LONDON W1G 9QR, UK

Version : 07/2015

http://www.urit.com

mailto:[email protected]

III

Guidance

General information for the operation of the analyzer is contained in thismanual, which covers the best guidance for a new operator to master thecharacteristics of the analyzer and operation methods, as well as for dailyinquiry. Do peruse before first operation.

This manual uses the following warning conventions:WARNING: Denotes a hazard which, if not avoided, could result in moderate

to serious injury.CAUTION: Denotes potential hazards that could result in a minor injury, also

used for conditions or activities which could interfere with properfunction of the analyzer.

NOTE: Denotes special operator/service information or standard practices.

Do read through this manual before operation, maintenance,displacement to the analyzer.

URIT Medical Electronic Co.,Ltd. is abbreviated as URIT

1

Chapter 1 System Description

1.1 Overview

Spincell3 is a multi-parameters, automated hematology analyzer designed forin vitro diagnostic use. It gives accurate test data of human blood cells as thenecessary reference of clinical diagnosis.

1.1.1 Function

Spincell3 adopts Coulter electrical impedance and colorimetry methods toobtain test data of WBC, RBC, PLT, HGB and other parameters. Meanwhileanalyzer gives 3 differentials of WBC and provides histogram informations.

1.1.2 Intended Use

The Spincell3 is appropriate to the qualitative and quantitative analysis of thevisible components in human beings blood.

System Description

2

1.1.3 Front Panel

1. Status IndicatorRun Indicator: Indicates that the analyzer is running a sample.Standby Indicator: Indicates that the analyzer is ready to run a sample.2. Aspiration ProbeAspirate samples.3. RUN KeyPress the RUN key to startup the aspiration probe and then analyze specimenonly in the screens of main menu or Quality Control. At other screens, the RUNkey is invalid.4. RecorderPrint the test result.5. Work Mode IndicatorThe light indicator means whole blood mode, and dark indicator meanspre-diluent mode.6. Touch Screen10.4 inch LCD . The screen is divided into 5 areas as shown in Figure 1-2.

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Figure 1-1 Front Panel

System Description

3

Prompt Information Mode System Time

Test Result

Menu

Figure 1-2 Screen

Prompt InformationDisplay the prompt information. ModeDisplay the work mode: whole blood mode or pre-diluent mode. System TimeDisplay the system date and time. Test ResultDisplay the test result. MenuDisplay functional menus which fall into two categories.First category menu is displayed across the bottom of the main menu screenas shown in Figure 1-3.

System Description

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Figure 1-3 Main Menu Screen

Func: Direct to second category menus.Info: Direct to next specimen’s information-input window.Rev: Direct to query stored specimens data.Histo: Direct to histogram-modification window of the current specimen.Drain: Dispel the diluent from the aspiration probe, mainly used for

pre-diluent mode.Trans: Transmit specimen data to the network.Print: Print the specimen data.Mute: Mute the alert sound.Help: Direct to system help window.Exit: Click “Exit , “Thank you, now turn off power” will appear to instruct

the operator to turn off the power switch on the rear panel.

Second category menu is shown in Figure 1-4:

Figure 1-4 Function Menu

Back: Return to the first category menus.Maint.: Direct to maintain screen to perform operations of flush, prime,

System Description

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cautery, etc.Limit: Direct to limit-setting screen to modify the limits of parameters.Stast.: Calculate the workload during a certain time.QC: Direct to quality-control window to process QC.Cal.: Direct to calibration window to calibrate the analyzer.Setup: Direct to setup window to reset parametersSev.: Direct to service window to process self-check and maintenance.Help: Direct to system help window.

7. Shortcut Key

Figure 1-5 Shortcut KeyPrint: Print the test result.Flush: Flush the WBC and RBC apertures to remove clog.Mode: Switch between whole blood mode and pre-diluent mode.Prime: Start the prime cycle to rinse the flow system.Drain: Dispel the diluent from the aspiration probe, mainly used for

pre-diluent mode.

System Description

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1.1.4 Rear Panel

Figure 1-6 Rear Panel

1. COM1 and COM2Connect to the standard RS-232 network.2. PRINTERConnect to the printers.3. USB PortConnect to USB equipment.4. PS2 portConnect to the keyboard and mouse.5. Grounding TerminalIt’s used to ground the analyzer.6. FanIt is for the heat dissipation of power supply.7. Power ReceptacleConnect to the main power cord to the analyzer.8. Power SwitchTurn the power supply on or off.9. SENSORConnect to the waste sensor.

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1011

System Description

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10. DETERGENTDetergent port connects to the detergent inlet tube.11. WASTEWaste port connects to the waste outlet tube.12. LYSELyse port connects to the lyse inlet tube.13. DILUENTDiluent port connects to the diluent inlet tube.

1.2 Parameters

Analyzer can automatically analyze the sample data, differentiates WBCs into3 differentials and displays 21 parameters and 3 histograms of WBC, RBC andPLT. Refer to Table 1-1 for details of 21 parameters.

Table 1-1 21 Parameters

Abbreviation Full Name Unit

WBC White Blood Cell Count 109cells/L

LYM% Lymphocyte Percent %

MID% Monocyte Percent %

GRAN% Granulocyte Percent %

LYM# Lymphocyte Count 109cells/L

MID# Monocyte Count 109cells/L

GRAN# Granulocyte Count 109cells/L

RBC Red Blood Cell Count 1012cells/L

HGB Hemoglobin Concentration g/L

HCT Hematocrit (relative volume of erythrocytes) %

MCV Mean Corpuscular Volume fL

MCH Mean Corpuscular Hemoglobin pg

MCHC Mean Corpuscular Hemoglobin Concentration g/L

RDW_CVRed Blood Cell Distribution Width Repeat

Precision%

RDW_SD Red Blood Cell Distribution Width STDEV fL

PLT Platelet Count 109cells/L

MPV Mean Platelet Volume fL

PDW Platelet Distribution Width fL

System Description

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PCT Plateletcrit %

P_LCR Large Platelet Ratio %

P_LCC Large Platelet 109cells/L

1.3 Structure

Spincell3 consists of a host, accesories and an external printer (optional). Ahost mainly includes FPGA board, WBC metering assembly, RBC/PLTmetering assembly, flow system and a touch screen etc.. Accesories includepower cord and grounding cord.

1.3.1 Flow System

The flow system is composed of solenoid valves, a vacuum pump, a forcepump, a vacuum chamber and plastic tubes.

Solenoid Valve ---These contact two-way or three-way solenoid valves controlthe flow of reagent.Vacuum Pump --- Pump the waste generated in the processing out to theanalyzer, and produce negative pressure.Force Pump --- Provide positive pressure for reverse clean and lyse mixture.Vacuum Chamber --- Generate negative pressure and play the role oftemporary waste reservoir.Plastic Tube --- Reagent and waste flow in the plastic tube.

1.3.2 Electrical System

1.3.2.1 ARM Board

ARM board is a hardware platform for Linux embedded system, a controlcenter of the analyzer. It is used to receive the information from mouse andkeyboard to control the operation of the instrument, to output the informationand display it on the LCD screen and print the test report as required.

1.3.2.2 FPGA Board

FPGA board is the control center of the analyzer; it controls the following

System Description

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components and their movement: All the valves open and close, reagent aspiration, rinse and waste

discharge. Run force pump and vacuum pump to offer power to mix reagent,

eliminate clog, aspirate and discharge reagents. Control step motors to aspirate sample and reagent. Control the A/D conversion of WBC, RBC/PLT and HGB; provide previous

service for the computer’s data processing; check all optical and electricalswitch movements.

1.3.2.3 LMS Board

LMS board is a volume measurement board, measuring a volume of bloodsamples to control the test time.A certain amount of diluted samples are counted after flowing through the rubyaperture. The liquid is measured by a system composed of a detector andmeasuring tube. When the liquid flows through the start detector, there will bean electrical signal that count is initiated. When the liquid flows through thestop detector, there will be an electrical signal again, that count is completed,as shown in Figure 1-7. In the process, if there are bubbles or other abnormalmovements in the flow system, the instrument will alarm. Troubleshootingplease refer to the relevant content.

Figure1-7

System Description

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1.3.2.4 Front-end Signal Panel

It is used to collect various signals, such as count electrical pulse, lightintensity, pressure, temperature, etc., please transfer them to the FPGA boardafter adjustment.

1.3.2.5 Switch Power Supply

It mainly provides DC12V, DC5V voltage to the ARM board, FPGA driver board,and operating voltage to motor, pump, valve, and recorder.

1.3.2.6 Front-end Power Panel

To provide the analog voltage and DC high voltage to front-end signal panel.

1.3.2.7 Valve and Motor Driver Board

Transform the signals from FPGA board, then drive the valve, motor and pumpto work.

1.3.2.8 WBC Metering Assembly

WBC metering assembly is composed of a signal collection board, electrodes,a micro-aperture sensor and flow system etc.. Signal Collection Board --- It provides constant current for electrodes.

Then amplifies and deals with the collected pulse signals for mainboard. Electrode --- There are two electrodes in WBC metering assembly. One is

located within WBC cup, and the other one is outer. Both electrodes aresubmerged in the conductive liquid, creating an electrical pathway throughthe micro-aperture.

Micro-aperture Sensor --- Micro-aperture sensor is mounted on the frontend of WBC cup. Particles pass through the aperture whose diameter is100μm when processing a sample.

Flow System --- The flow system uses negative pressure to aspiratediluent, detergent and sample from each container into metering tube, anddischarge waste at the end of the processing. The step motor controlledby mainboard runs to add specific volume lyse into WBC cup, then mix itby the air created by force pump.

System Description

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1.3.2.9 RBC/PLT Metering Assembly

RBC/PLT Metering Assembly is composed of a signal collection board,electrodes, a micro-aperture sensor and flow system etc.. Signal Collection Board --- It provides constant current for electrodes.

Then amplifies and deals with the collected pulse signals for mainboard. Electrode --- There are two electrodes in RBC/PLT metering assembly.

One is located within RBC/PLT cup, and the other one is outer. Bothelectrodes are submerged in the conductive liquid, creating an electricalpathway through the micro-aperture.

Micro-aperture Sensor --- Micro-aperture sensor is mounted on the frontend of RBC/PLT cup. Particles pass through the aperture whose diameteris 68 μm when processing a sample.

Flow System --- The flow system uses negative pressure to aspiratediluent, detergent and sample from each container into metering tube, anddischarge waste at the end of the processing.

1.3.3 Display

Spincell3 uses a 10.4-inch LCD which can display 21 parameters and 3histograms.

1.4 Accessory

The accessories of the analyzer include power cord, grounding cord, externalprinter (optional), etc.. And the printer should be supplied or authorized bymanufacturer.

1.5 Sample Volume

Whole Blood Mode for Venous Blood: Venous Blood 10 μLPre-diluent Mode for Peripheral Blood: Capillary Blood 20 μLWhole Blood Mode for Peripheral Blood: Capillary Blood 10 μL

System Description

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1.6 Reagent Volume for Single Sample

Diluent: 31mLDetergent: 8mLLyse: 0.7mLNOTE: Reagent consumption is various according to the software version.

1.7 Test Speed

Spincell3 is able to process at least 60 samples per hour.

1.8 Storage

Spincell3 equipped with a memorizer which can store at least 100,000samples data.

1.9 Background Test

WBC≤0.2×109/L；RBC≤0.02×1012/L；HGB≤1g/L；PLT≤10×109/L

1.10 Carryover

WBC≤0.5%；RBC≤0.5%；HGB≤0.5%；HCT≤0.5%；PLT≤0.5%

1.11 Accuracy

The accuracy of analyzer should be complied with Table 1-2.Table 1-2 Accuracy

Parameter Acceptable Limits（%）

WBC ≤±2.0%

RBC ≤±1.5%

HGB ≤±1.5%

MCV ≤±0.5%

HCT ≤±1.0%

PLT ≤±4.0%

System Description

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1.12 Precision

The precision of analyzer should be complied with Table 1-3.Table 1-3 Precision

ParameterAcceptable Limits

（CV/%）Precision Range

WBC ≤2.0% 4.0×109/L ~ 15.0×109/L

RBC ≤1.5% 3.00×1012/L ~6.00×1012/L

HGB/

HCT

≤1.5%

≤1.0%

100 g/L ~180g/L

35%~50%

MCV ≤0.5% 76fL ~110fL

PLT ≤4.0% 100×109/L ~500×109/L

1.13 Linearity

The linearity of analyzer should be conformed to Table 1-4.Table 1-4 Linearity

Parameter Linearity Range Acceptable Limits

WBC0×109/L~10.0×109/L ≤±0.3×109/L

10.1×109/L ~99.9×109/L ≤±5%

RBC0×1012/L ~1.00×1012/L ≤±0.05×1012/ L

1.01×1012/L ~9.99×1012/L ≤±5%

HGB0 g/L ~70 g/L ≤±2g/L

71 g/L ~300 g/L ≤±2%

PLT0×109/L ~100×109/L ≤±10×109/L

101×109/L ~999×109/L ≤±10%

1.14 Transport and Storage Specifications

1) Temperature: -10℃~55℃2) Relative Humidity: ≤95%RH3) Barometric Presssure: 50kPa~106kPa

System Description

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1.15 Environment Requirement

1) Temperature: 15℃~35℃2) Relative Humidity: ≤90%RH3) Barometric Pressure: 60kPa~106kPa

1.16 Electrical Requirement

1) Power Supply: AC 100V～240V2) Frequency: 50/60Hz3) Power: 100VA-180VA4) Fuse: 250V/3A

1.17 Reagent

Reagent is configured specifically for the Spincell3 in order to provide optimalsystem performance. Delivery inspection of reagents has been done strictlyaccording to product standards. Spincell3 indices are derived in the conditionof using specified reagents. Thus using non- manufacturer reagents may leadto measurement errors even malfunctions.

Reagents must be stored at room temperature to ensure optimal performance.All reagents should be protected from direct sunlight, extreme heat, and freezeduring storage. Temperatures below 0℃ may cause reagent layering so thatchanges its chemical properties and conductivity.

Reagent inlet tubes have a cap attached which can minimizes evaporation andcontamination during use. However, reagent quality may deteriorate with time.Therefore, use all reagents within the dating period.

1.17.1 Diluent

Diluent is a kind of reliable isotonic diluents which can meet the requirementsas follows:1) Dilute WBC, RBC, PLT, HGB.

System Description

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2) Keep the shape of cells during test process.3) Offer appropriate background value.4) Clean WBC and RBC micro-aperture and tubes.

1.17.2 Lyse

Lyse is a new-type reagent without NaN3 complex and cyanide which canmeets the requirements as follows:1) Dissolve RBC instantly with minimum ground substance complex.2) Transform the membrane of WBC to diffuse cytoplasm, and then WBC

shrinks to form membrane-bound nuclei. As a result, WBC present ingranular shape.

3) Transform the hemoglobin to form hemo-compound which is suitable forthe measurement in the condition of 540nm wavelength.

4) Avoid the pollution caused by cyanide.

1.17.3 Detergent

Detergent contains the active enzyme which can dissolve the agglomeratedprotein in the WBC, RBC cups and measurement circuit.

1.17.4 Probe Detergent

Probe detergent contains effective oxide to dredge the stubbornly-blockedapertures on the WBC, RBC cups.

1.17.5 Note of Reagent Use

1) Using supporting reagentsAppropriate reagent is necessary for normal operation, daily maintenance andaccurate results. The reagent used must match with analyzer model. Thereasons are as follows: Impedance method is to get the data according to cell pulse size and

setting threshold value. Cell pulse size is related to type, concentration and adding amount of lyse

as well as hemolysis time. Cell pulse size is related to osmotic pressure of diluents, ion strength and

System Description

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conductivity. Cell pulse size is related to valve voltage, mesh current and pulse gain.2) Please operate under professional ‘s instruction.3) Avoid contacting with skin and eyes. If does, rinse with water and seek

medical advice immediately.4) Avoid inhaling reagent gas.

1.17.6 Reagent Storage

1) Please store in a cool place.2) Seal the cap of the container to avoid evaporation and contamination.3) Avoid freeze.4) Reagent should be use within 60days after open, if not, dispose as waste.

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Chapter 2 Principles of Operation

Principles of operation of Spincell3 automated hematology analyzer will bediscussed in this chapter. The two independent measurement methods are:1) The electrical impedance method for determining the quantity and volume

of blood cell.2) The colorimetric method for determining the content of hemoglobin.

2.1 Principles of Measuring

The measurement is mainly on the quantity, volume of blood cells and HGB.

2.1.1 Electrical Impedance Method

The cells are counted and sized by the electrical impedance method. As Figure2-1 shows, this method is based on the measurement of changes in electricalcurrent which are produced by a particle, suspended in a conductive liquid, asit passes through an aperture of known dimensions. An electrode issubmerged in the liquid on either side of the aperture in order to create anelectrical pathway through it.

As each particle passes through the aperture, a transitory change in theresistance between the electrodes is produced. This change produces ameasurable electrical pulse. The number of pulses generated is indicative ofthe number of particles that traversed the aperture. The amplitude of eachpulse is essentially proportional to the volume of the particle that produced it.

Each pulse is amplified and compared to internal reference voltage channels.These channels are delineated by calibrated size discriminators to accept onlypulses of a certain amplitude. Thus, the pulses are sorted into various sizechannels according to their amplitude.

Principles of Operation

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Figure 2-1 Electrical Impedance Method

The size channels are basically divided into three categories by a pre-setclassification program in the analyzer as follows:

WBC 35—450 fLRBC 30—110 fLPLT 2—30 fL

According to the volume, WBCs handled by lyse can be subdivided into threeCategories: Lymphocyte (LYM), Monocyte (MID) and Granulocyte (GRAN).

LYM 35—98 fLMID 99—135 fLGRAN 136—450 fL

2.1.2 HGB Colorimetric Method

Lyse added into the blood sample will crack the membrane of red blood cellspromptly and transfer into a kind of compound which can absorb thewavelength of 540 nm. Through the comparison of the absorbance betweenthe pure diluent and the sample, the concentration of sample hemoglobin iscalculated.


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2.2 Reagents Function

In Spincell3, counting system has a high sensitivity of the cell volume. Cellswhich are suspended in conducting liquid should be protected from physicalcondense and adhesion. Control the osmotic pressure of conducting liquid(mainly diluent) and keep the structure of cells so as to minimize the volumechange. Lyse can dissolve the RBC membrane fleetly and keep the structureof WBC so that the instrument can count and classify cells.

2.3 Calculation of Parameters

All parameters of blood sample are expressed in three ways:1) parameters generated by analyzer directly: WBC，RBC，PLT，HGB ，MCV.2) parameters generated by histograms: LYM%，MID%，GRAN%，HCT，

RDW_CV, RDW_SD, MPV, PDW, P_LCR, P_LCC,.3) parameters derived from certain formulas: LYM#，MID#，GRAN#，MCH，

MCHC，PCTThe formulas are as follows:

HCT（%）= RBC×MCV/10 MCH（pg）= HGB/RBC MCHC（g/L）= 100×HGB/HCT PCT（%）=PLT×MPV/10000 LYM（%）= 100×AL /（AL+AM+AG） MID （%）= 100×AM /（AL+AM+AG） GRAN（%）= 100×AG/（AL+AM+AG）

app:ds:cell

app:ds:membrane


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WBC histogram is as Figure 2-2:

Figure 2-2 WBC Histogram

AL: quantity of cells in LYM area.AM: quantity of cells in MID area.AG: quantity of cells in GRAN area.

The calculation formulas for absolute value of lymphocyte (LYM#), monocyte(MID#) and granulocyte (GRAN#) are as follows:

Lymphocyte（109L） LYM# = LYM%×WBC/100 Monocyte（109L） MID# = MID%× WBC/100 Granulocyte（109L） GRAN# = GRAN%×WBC /100 RBC Distribution Width Repeat Precision（RDW-CV）is derived from

RBC histogram, shows the volume distribution differentiationcoefficient of RBC, with the unit of %。

RBC Distribution Width Standard Difference (RDW-SD) is derived fromRBC histogram，shows the volume distribution standard difference ofRBC, with the unit of fL.

Platelet Distribution Width (PDW) is derived from PLT histogram，shows the volume distribution of PLT.

Mean Platelet Volume (MPV) is derived from PLT distributionhistogram, its unit is fL.


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LD UD( )12fL

P-LCR

Figure 2-3 P-LCR

P-LCR indicates the ratio of large platelet (≥12 fL). It is derived fromPLT histogram. See Figure 2-3. LD,UD is the differentiating line of 2~6fL and 12~30 fL. These two lines are decided by analyzerautomatically. P-LCR is the ratio of particles between 12 fL line and UDto particles between LD and UD.

P_LCC: Large platelet，it is the particles between 12 fL line and UD.

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Chapter 3 Installation and Specimen Analysis

Initial installation must be performed by an manufacturer authorized engineerto ensure optimal performance of analyzer. Installation procedures must berepeated conform to this chapter if the analyzer is moved from the originalinstallation site.NOTE: Install analyzer by an unauthorized or untrained person bymanufacturer could result in damage to analyzer which is exclusive of thewarranty. Never attempt to install and operate the analyzer without anmanufacturer authorized representative.

3.1 Unpacking and Inspection

Carefully remove the analyzer and accessories from shipping carton, keep thekit stored for further transport or storage. Check the following:1) Quantity of accessories according to the packing list.2) Leakage or soakage.3) Mechanical damage.4) Bare lead, inserts and accessories.

Do contact manufacturer Customer Support Center if any problem occurs.

3.2 Installation Requirements

Details please refer to chapter 12 Precautions, Limitations and Hazards

WARNING: Not for home use.WARNING: Not for therapy.WARNING: The Power switch is used as disconnect device, the disconnectdevice shall remain readily operable. Please do not place the instrument in thelocation where is difficult to operate the disconnect device.

CAUTION: Away from direct sunlight.CAUTION: Avoid temperature extreme.

Installation and Specimen Analysis

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CAUTION: Away from centrifuge, X-ray equipment, display or copier.CAUTION: No cell phone, wireless phone and equipments with strongradiation which will interfere with the normal operation of the analyzer.

3.3 Power Supply Inspection

Be sure that the system is located at the desired site before attempting anyconnections. See Table 3-1 for details.

Table 3-1 Power Supply InspectionOptimal Voltage Voltage Range FrequencyAC220V AC（100—240）V （50/60）Hz

WARNING: A grounded power outlet is required to connect directly with thegrounding terminal on the rear panel. Be sure to guarantee the security of thework site.CAUTION: A fluctuated voltage would impair performance and reliability of theanalyzer. Proper action such as the installation of E.C manostat (not providedby manufacturer) should be taken before operation.CAUTION: Frequent power failure will seriously decrease the performanceand reliability of the analyzer. Proper action such as the installation of UPS (notprovided by manufacturer) should be taken before operation.

3.4 Tubing Installation

There are four tube-connectors on the rear panel: LYSE, DILUENT,DETERGENT and WASTE, each of which is wrapped with a cap to avoidcontamination by the manufacturer before shipment. Uncover and set the capsaside carefully for further use on initial installation.

3.4.1 LYSE Tubing Installation

Remove the lyse tube with red faucet from reagent kit and attach it to LYSEconnector on the rear panel, place the other end into the lyse container. Twistthe cap until secure. Place the container on the same level as the analyzer.


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3.4.2 DILUENT Tubing Installation

Remove diluent tube with blue faucet from reagent kit and attach it to DILUENTconnector on rear panel. Place the other end into diluent container. Twist capuntil secure. Place the container on the same level as the analyzer.

3.4.3 WASTE Tubing Installation

Remove the waste tube with black faucet from reagent kit and attach it toWASTE connector on the rear panel, connect BNC plug with the socketmarked “SENSOR” on the rear panel. Twist the tube’s cap clockwise onto thewaste container until secure. Place the container on the level at least 50cmlower than the analyzer.

3.4.4 DETERGENT Tubing Installation

Remove the detergent tube with yellow faucet from reagent kit and attach it toDETERGENT connector on the rear panel. Place the other end into thedetergent container. Twist the cap until secure. Place the container on thesame level as the analyzer.CAUTION: keep the tube in loose condition after installation, no distortion orfolding.CAUTION: All the tubes should be installed manually. Do NOT utilize any tool.CAUTION: If any damage or leakage occurs in the reagent container, or thereagents have exceeded expiry date, contacts manufacturer Customer SupportCentre for replacement.

WARNNING: The waste must be handled with biochemical or chemicalmethods before disposal, or it will cause contamination to the environment.Users have obligation to follow the local and national environmentalregulations.


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3.5 Printer Installation (optional)

Take out the printer from the shipping carton. Inspect the printer carefullyaccording to its manual and Section 3.1 and perform the following procedures:1) Find a suitable location adjacent to the analyzer. Location of at least 30cm

away from analyzer on its right side is recommended.2) Assemble the printer as directed in the printer manual.3) Connect the printer and analyzer with printer cable which plug into

PRINTER or USB on rear panel of the analyzer according to the type ofprinter.

4) Be sure that the printer power switch is OFF; plug the end of power cord topower socket.

5) Install printing paper as directed in the manual.

3.6 Keyboard and Mouse Installation

Remove keyboard, mouse and mouse pad from the shipping carton, and insertthe plugs of keyboard and mouse into the two connector of the line, thenconnect to the rear panel with “PS/2” port. It is recommended to place thekeyboard beneath the display.

3.7 Power Connection

Make sure the power switch is OFF (O) and the grounding terminal on the rearpanel is well grounded firstly, then connect the analyzer to the main power withthe power cable.

3.8 Startup

Turn on the power switch on the rear panel, then the status indicator on thefront panel will be orange. The analyzer will start self-checking after loading,and automatically aspirate the diluent， detergent and lyse, then rinse thetubing.The main menu screen is displayed after self-checking (See Figure 3-1).


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Figure 3-1 Main Menu Screen

3.9 Background Test

Background test should be performed after startup and before blood sampletest, operate as follows:1) Put the clean empty tube under the aspiration probe. At main menu screen,

click the mode switch button on the top of the screen, current mode will beswitched to “Pre-diluent” mode, then click “Drain” to discharge thediluent into the tube.

2) At main menu screen, click “Info”, and then modify ID to 0, click “OK” backto save it.

3) Click "Pre-diluent" to switch to “Whole Blood” mode, put thetube containing diluent beneath aspiration probe and ensure the probetouch the bottom of tube.

4) Press RUN key on the front panel, move away the tube after the beepsounds. Then the analyzer starts to count and measure automatically.

5) Counting time of RBC, WBC will be displayed at the lower right corner ofscreen during counting. Analyzer will alarm and display the error at top leftcorner if the counting time is too long or too short. Refer to Chapter 11 for


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problem correction.6) The acceptable range of background is listed in Table 3-2.

Table 3-2 Acceptable Range of BackgroundParameter Acceptable RangeWBC ≤0.2x109/LRBC ≤0.02x1012/LHGB ≤1g/LPLT ≤10x109/L

If the background result is out of acceptable range, repeat the aboveprocedures until reach the acceptable results.NOTE: ID number of background test is set to be 0 by the software tomake the result not memorized in the analyzer.NOTE: The ID number of blood sample test can NOT be set to 0.

3.10 Quality Control

Quality control should be performed before daily test or on the initialinstallation. Refer to Chapter 6.

3.11 Calibration

manufacturer calibrates the analyzer in factory before shipment. On the initialinstallation, if the background results and quality control are normal,recalibration is not necessary. If not and there are shifts or trends in someparameters, recalibrate the analyzer referring to Chapter 7.

3.12 Collection of Blood Sample

CAUTION: Consider all the clinical specimens, controls and calibrators etcthat contain human blood or serum as being potentially infectious, wear labcoats, gloves and safety glasses and follow required laboratory or clinicalprocedures when handling these materials.CAUTION: Blood collection and disposal should be performed according tothe local and national environmental regulations or laboratory’s requirements.CAUTION: Be sure the blood collection clean and contamination-free. All


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specimens must be properly collected in tubes containing the EDTA(EDTA-K2•2H2O) anticoagulant used by the laboratory.CAUTION: Do not shake the sample tube violently.NOTE: Venous blood can only be stored for 4 hours at room temperature.manufacturer recommends the blood sample be kept at temperature between2-8℃ for longer storage.

3.12.1 Venous Blood Collection

Collecting whole blood sample through vein-puncture and store in a cleansample tube with EDTA-K2•2H2O, which can keep the configuration of WBC,RBC and avoid platelets aggregation. Gently shake the tube 5~10 times tomake it well mixed.

3.12.2 Peripheral Blood Collection

Capillary blood is usually collected from finger tip. The volume of sample tubeis set to be 20μl.CAUTION: Never over-press the finger avoiding collecting tissue liquid intosample tube, tissue liquid will cause error in results.

3.13 Mode Switch

In the screen as Figure 3-1 shows, click the mode switch button on the top toswitch among Whole Blood Mode for Venous Blood, Pre-diluentMode for Peripheral Blood and Whole Blood Mode for Peripheral Blood.Corresponding sign on screen will indicate current operating mode. Press theshortcut key “Mode” in front of the analyzer can also switch between wholeblood mode and pre-diluent mode.

3.14 Sample Counting and Analysis

Sample counting and analysis is processed as following procedures.


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3.14.1 Information Input

Input information manuallyClick “Info” at main menu screen, the Info edit window present (shown inFigure 3-2), input or select data. Click “OK” to save the input data and return tothe main menu. Click “Cancel” to cancel the input data and return to the mainmenu.

Figure 3-2 Info Edit Window

Name: Input alphanumeric characters.Sex: Select male or female. If not selected, default as blank.Age: Input Year, Month and Day.Blood : Select A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-. ORh+, O Rh-. If not selected, default as blank.Limit: Select Auto, Man, Woman, Child, Infant, Neonate, General, User 1,User 2, User 3. If Auto is selected, the reference values are listed as Table 3-3.

Table 3-3 Reference Value

Reference value Age SexGeneral No input Blank, M, F

General ≥16-year Blank

Man ≥16-year MWoman ≥16-year F

Child ≥1-year and <16-year Blank, M, F

Infant ≥1-month and < 1-year Blank, M, FNeonate <1-month Blank, M, F


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ID: The ID number is in range from 00000000-99999999. If no ID input, the IDof current sample will be automatically added follow the last one.Sample No.: Input the sample barcode number.Bed No.: Input bed No. of patient.Sender: Input sender’s name or code.Dept.: Input department name or code of operator.Checker: Input checker’s name or code.Assessor: Input assessor’s name or code.

NOTE: The ID number is set to 0 only under background test. The bloodsample ID CAN NOT be 0.

3.14.2 Counting and Analysis

Counting and analysis should be performed within 3~5 minutes after bloodcollection. Pre-diluent Mode for Peripheral Blood1) Present the empty sample tube under the aspiration probe. At main menu

screen, click “Drain”; the diluent will be dispensed into the tube.2) Remove the tube, add 20μl of the blood sample to the tube, and gently

shake the tube to make them well mixed.3) Present the well-mixed sample under the aspiration probe; make sure the

probe touches the tube bottom slightly.4) Press RUN key on the front panel and remove the sample after hearing

beep sound.5) Process of analysis will take some time, please wait a moment.

Whole Blood Mode for Venous Blood1) Gently shake the tube to well mix the blood sample, then place the sample

tube beneath the probe, make sure the probe touches tube bottom slightly.2) Press RUN key and remove the sample after hearing beep sound.3) Process of analysis will take some time, please wait a moment.


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Whole Blood Mode for Peripheral Blood1) Gently shake the tube to well mix the blood sample, then place the sample

tube beneath the probe,2) Press RUN key and remove the sample tube after hearing beep sound.3) Process of analysis will take some time, please wait a moment.

Test results and histograms of WBC, RBC and PLT will be displayed at mainmenu screen after counting and analysis (see Figure 3-1).If Auto Rec or Auto Print is ON (set in “system setting” screen), the test resultswill be printed out automatically.If problems like clog or bubbles occur during the counting and analysisprocedures, the analyzer will alarm and give indication at the top left corner ofthe screen. The test results are invalid. Refer to Chapter 10 for solution.If Auto Rec or Auto Print is ON (set in “system setting” screen), the test resultswill be printed out automatically.If problems like clog or bubbles occur during the counting and analysisprocedures, the analyzer will alarm and give indication at the top left corner ofthe screen. The test results are invalid. Refer to Chapter 11 for solution.

3.14.3 Special Function

There are 2 kinds of alarms: parameter alarm and histogram alarm.

3.14.3.1 Parameter Alarm

”H” or “L” present on the right side of the parameter means the result is out ofthe range of reference value.“***” means the result is invalid or out of display range.

3.14.3.2 Histogram Alarm

If the WBC Histogram is abnormal, R1, R2, R3, R4, RM will be displayed onthe right side of the histogram.

R1 indicates there is abnormality in the left side of LYM wave peak, whichprobably caused by incomplete hemolysis of RBC, platelet clump, giant

app:ds:hemolysis


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platelet, plasmodium, nucleated RBC, abnormal lymphocyte, proteinic or fatgranule.

R2 indicates there is abnormality in the area between LYM wave peak and MIDwave, which probably caused by pathologic lymphocyte, plasmocyte, atypialymphocyte, original cell or an increase in eosinophil and basophilia,

R3 indicates there is abnormality in the area between MID wave and GRANwave peak, which probably caused by immature granulocyte, abnormal cellsubpopulation, eosinophilia.

R4 indicates there is abnormality in the right side of GRAN wave peak, whichprobably caused by an absolute increase in granulocyte.

RM indicates there are two or more preceding alarms.

When the histogram of PLT has abnormalities, PM alarm will be shown in theright side.

PM indicates there is ill-defined boundary between PLT and RBC, whichprobably caused by the present of giant platelet, platelet clump, small RBC,cell debris or fibrin.

3.15 Result Analysis

Spincell3 provides plenty and convenient result analysis functions. Click “Histo” to modify the test results. Refer to Section 3.18 in this chapter

for details. Click “Trans” to transmit the data to network. Click “Print” to print data report of current blood sample by recorder or

printer. Click “Mute” to mute or sound the alarm. Click “Help” to get necessary help. ”H” or “L” present on the right side of the parameter means the result is out

of the range of reference value. “L” means result is lower than the lowerlimit while “H” means result is higher than upper limit.

app:ds:plasmodium

app:ds:lymphocyte


33

If counting time lower than system setting time, the system will alarm“WBC bubble” or “RBC bubble”, at the same time display “B” before testresult.

If counting time higher than system setting time, the system will alarm“WBC clog” or “RBC clog”, at the same time display “C” before test result.

Because of large display of limit sequence, it should be set “None” inSystem Setting for limit sequence firstly, then “L”, “H”, “B”, “C” will appear.

NOTE: If Parameter value is ***, it indicates invalid data.

NOTE: If there is a PM alarm of PLT histogram , PDW probably will be ***.

NOTE: WBC differential may be incorrect if WBC is lower than 0.5 x109 /L.Microscope examination is recommended.

3.16 Report Output

Spincell3 offers recorder and printer which are optional according to customerneeds. After blood sample analysis completed, if Auto Print is ON, test reportwill be printed automatically by recorder or printer; if the Auto Trans is ON, testresults will be transmitted to network automatically.

The recorder, printer and transmit are set up at Settings window. Refer toChapter 5 for details.

Click “Trans” to transmit data of the current sample to network.

Click “Print” to print test report of current sample by recorder or printer.

3.17 Result Modification

If the auto-classification of floating limit for WBC, RBC and PLT do not reachclinical or laboratory requirements on special samples, manual classification isfeasible.

CAUTION: Unnecessary or incorrect manual classification will causeunreliable test results. It is recommended to microscopic exam before clinicaluse.


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The procedures are as follows:1) At main menu screen click “Histo”, then the interface as shown in Figure

3-3 will display. The histogram of WBC has been selected and surroundedby a rectangle of red line, then click “Param” to select WBC, RBC, PLTdiagram parameters that needs modification.

Figure 3-3 Classification

2) Once the diagram parameter need to be modified is selected, click “Class”to select the desired classification, then the classified line will change fromwhite line to red line.

3) Click “Left” or “Right” to move the classified line, and the value of classifiedline will be indicated at the lower right of the screen.

4) Click “Back” after modification, the dialog box as shown in Figure 3-4 willdisplay; click “NO” to cancel the modification, while click “YES” to save themodified results.

Figure 3-4 Save Dialog Box


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3.18 Shutdown

Shutdown procedure is performed after daily operation and before turning theanalyzer off. Daily maintenance and tubing-clean avoid protein aggregationduring non-working and keep system clean. Shutdown procedure is as follows:1) At main menu screen, click “Exit”, shutdown information will appear (see

Figure 3-5).

Figure 3-5

If turn off the instrument, click “Yes”. After finishing maintenance, cleaningand shutdown procedures, “Thank you, and now turn off power” willappear to instruct operator to turn off the power switch on rear panel.

2) Tidy the work platform and dispose waste.3) Click “No” if operator does not want to shutdown analyzer temporarily.

NOTE: Wrong operations on shutdown procedure will decrease reliability andperformance of the analyzer, any problems derived from that will NOT beguaranteed free by manufacturer.CAUTION: May lead to data loses if turn off the analyzer against procedures.

3.19 Data Query

The information, parameters and histograms of test results can be reviewedand printed out by recorder or printer.At main menu screen, click “Rev” to enter query screen as shown in Figure3-6.Click “Condi” at query screen, then condition query screen will appear asshown in Figure 3-7. Operator can query the results according to Date, Name,Barcode，Dept, Sender and Checker. In Figure 3-7, enter the time interval, click“OK”, and then the samples in this time interval will be shown in the query list.As shown in Figure 3-8.


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Figure 3-6 Query

Figure 3-7 Condition Query


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Figure 3-8 Data Query

3.19.1 Selection, Browse, Modification and Output of Data

At main menu screen, click “Func”，and then click “Rev” to enter query screen.Data of today will be displayed in the list box as Figure 3-6.Select data in the list, and then click “Detail”, that the analyzer enters into detailinquiry window.Condi: Query data that are compliant with specific criteria in certain period.Detail: Select a data in the list, click “Detail”, the parameters result andhistograms of selected data will be displayed.Pgprv/Pgnex: If the data is too much to display in one page, the system willdisplay the data in more pages. Click “Pgpre” or “Pgnex” to view moreinformation.Print: Click “Print” to print the selected data.P_All: Click “P_ All” to print all the data in current list by printer.Count: Click “Count” to print all the data saved in list by printer according tocounterfoil format.Back: Click “Back” to go back to main menu screen.


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3.19.2 Data Deletion

If the sample quantity reaches a certain amount and takes up a large savespace, operator can delete the data termly if necessary. Data deletion isdivided into “Delete” and “Delete All”.(1) Delete AllClick “DelAll”, a dialog box as Figure 3-9 will present, input password 9999,then the system will prompt to ask whether you want to delete all, see Figure3-10, if click “Yes”, then the system will perform all delete operations.

Figure 3-9 Password

Figure 3-10 Delete All Query Dialog Box

(2) Delete SingleIn the interface as shown in Figure 3-8, select the data and then click “Del”, thedialog box as Figure 3-11 will display.

Figure 3-11 Delete Query Dialog Box

Select Yes to delete the data. Select No to cancel the deletion.

NOTE: Be aware that the data once being deleted, it can NOT be recovered,please operate with caution.


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3.19.3Workload Statistics

At main menu screen, click “Func”→ “Stast” to enter Workload statisticswindow. See Figure 3-12. Operation procedure is as follows:

Figure 3-12 Workload Statistics1) At “From” and “To”, select starting date and ending date in pop-up calendar,

then press “OK”.2) Select one statistic type on left side of the Workload Statistics screen and

then all items will be displayed in the middle list box.3) Select item needed (multi-select is allowed), click “Stast”, and then the

desired data will be displayed in list on right.4) Click “Back” to return to main menu screen.5) Choose one sender, and click “Print”, then all the items will be print.

3.20 Special Function

3.20.1 Precision Counting

At Query screen, operator may check the sample precision.


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3.20.1.1 Select Sample Results

After data review from condition query, click one result, then press space bar(click “Select” if using touch screen), the result will be selected and in redletters as Figure 3-13.

Figure 3-13 Select Samples

3.20.1.2 Check Precision

After selecting one sample result as preceding method, press F9 (click “CV” ifusing touch screen) to enter the CV data screen like as Figure 3-14.“Mean” indicates the parameter average value of selected samples. “CV”indicates the Coefficient of Variance of corresponding parameter.NOTE: The system can only calculate CV automatically when more than onesample results are selected.NOTE: If only one sample result is selected, the “Mean” indicates the sampleresult itself.


41

Figure 3-14 CV Count

3.20.2 Trend Graph

At Query screen, operator may review the sample trend graph.First, select one sample result.After data review from condition query, click one result, and press space bar(click “Select” if using touch screen), the result will be selected to be in redletters like Figure 3-15.


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Figure 3-15 Select Samples

Second, review the trend graph.After selecting one sample result as preceding method, press F8 (click “Trans”if using touch screen) to enter the trend graph screen like Figure 3-16


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. Figure 3-16 Trend Graph

Param.: Click “Param” to review another parameter trend graph;Left: Click “Left”, then the chart pole will shift one grid to the left. See Figure3-17.Right: Click “Right”, then the chart pole will shift one grid to the right. SeeFigure 3-18.


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Figure 3-17 Left Shift Chart Pole

Figure 3-18 Right Shift Chart Pole

Back: Click “Back” to return to Query screen.

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Chapter 4 Soft Keyboard

Spincell3 adopts t-touch interactive mode. System provides soft keyboardinput mode to facilitate the data input and other input operations. Softkeyboard is as Figure 4-1 shown.

Figure 4-1 Keyboard

The default soft keyboard is in English lowercase mode, click "CAP" key toswitch to English uppercase mode, as shown in Figure 4-2.

Figure 4-2 Uppercase Mode

4.1 Soft Keyboard Introduction

1. LayoutThere are 43 keys in soft keyboard: 10 number keys, 26 alphabet keys,backspace key, slash key, space key, CAP key, CH key and EN key.

“<--”: Backspace key, delete the character before cursor;“/”: Slash key, enter a slash;“Spc”: Space key，enter a space;“CAP”: Switch between lowercase and uppercase;“CH”: Chinese input method.“EN”: English input method.

Soft Keyboard

46

2. English Character InputFirst click the target edit box, at this time the top of the target interface is blue,then click soft keyboard, right now the top of the soft keyboard changes fromgray to blue. Click “EH” to switch to English characters input mode. User canswitch between English uppercase or lowercase by clicking “CAP” and thenclick the keyboard to input.

NOTE: If current input mode is Chinese, clicking "CAP" to switch to Englishuppercase input mode directly. In English uppercase input mode, Chinesecharacter can not be input.

3. Delete CharacterFirst move the cursor behind the character that needs to be deleted, click "<--"to delete the character before the cursor.

4.2 Function

The soft keyboard is displayed in the following screens: data edit, conditionquery, parameters limit setting, control edit, system calibration, system settingand service.

4.2.1 Data Edit

The procedure of inputting information in edit box is as follows:1) Click target edit box, move the cursor on the edit box;2) Click the soft keyboard, then user can input data through soft keyboard;3) After data input, click data edit screen to move the cursor to it. Click “OK”

to save the operations, click “No” to cancel and exit the data edit screen.See Figure 4-3.

Soft Keyboard

47

Figure 4-3 Data Edit

4.2.2 Condition Query

Click “Condi” at query screen, condition query and soft keyboard will pop up atthe same time, and soft keyboard is warded off by condition query screen.The procedure of inputting information in edit box is as follows:1) Click target edit box, move the cursor on the edit box;2) Click the soft keyboard, this moment soft keyboard is warded off by

condition query screen, click soft keyboard to input data;3) After data input, click condition query screen to move the cursor on this

screen, click “OK” to query according to input conditions, click “No” tocancel and exit query. See Figure 4-4.

Soft Keyboard

48

Figure 4-4 Condition Query

4.2.3 Parameter Limit Setting

Enter the parameter setting screen, click "Keyboard", soft keyboard will pop up,if click "Keyboard" again, soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box, move the cursor on edit box;2) Click soft keyboard, user can input data through soft keyboard;3) After data input, click parameter limit setting screen to move the cursor on

this screen. This moment soft keyboard will be hidden. If click "Keyboard"again, the soft keyboard will pop up;

4) When the focus is on parameter limit setting screen, click “OK” to save,click “Back” to cancel and exit. See Figure 4-5.

Soft Keyboard

49

Figure 4-5 Parameter Limit Setting

4.2.4 L-J QC Edit

Enter L-J QC Edit screen, click "Keyboard", then soft keyboard will pop up, ifclick "Keyboard" again, soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box first, move the cursor on the edit box;2) Click soft keyboard, user can input data through soft keyboard;3) After data input, click L-J QC edit screen to move the cursor on this screen.

This moment soft keyboard will be hidden. If click "Keyboard" again, thesoft keyboard will pop up;

4) When the focus is on L-J QC edit screen, click “OK” to save, click “Back” tocancel and exit. See Figure 4-6.

Soft Keyboard

50

Figure 4-6 L-J QC Edit

4.2.5 X-B QC Edit

Enter X-B QC Edit screen, click "Keyboard", then soft keyboard will pop up, ifclick "Keyboard" again, soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box first, move the cursor on edit box;2) Click soft keyboard, then user can input data through soft keyboard;3) After data input, click X-B QC edit screen to move the cursor on this screen,

this moment the soft keyboard will be hidden. If click "Keyboard" again, thesoft keyboard will pop up;

4) When the focus is on X-B QC edit screen, click “OK” to save, click “Back”to cancel and exit. See Figure 4-7.

Soft Keyboard

51

Figure 4-7 X-B QC Edit

4.2.6 X QC Edit

Enter X QC Edit screen, click "Keyboard", then the soft keyboard will pop up, ifclick "Keyboard" again, soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box first, move the cursor on the edit box;2) Click soft keyboard, then user can input data through soft keyboard;3) After data input, click X QC edit screen to move the cursor on this screen,

this moment soft keyboard will be hidden. If click "Keyboard" again, thesoft keyboard will pop up;

4) When the focus is on X QC edit screen, click “OK” to save, click “Back” tocancel and exit. See Figure 4-8.

Soft Keyboard

52

Figure 4-8 X QC Edit

4.2.7 Manual Calibration

Enter manual calibration screen, click "Keyboard", then soft keyboard will popup, if click "Keyboard" again, soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box, move the cursor on the edit box;2) Click soft keyboard, then user can input data through soft keyboard;3) After data input, click manual calibration screen to move the cursor on this

screen, this moment soft keyboard will be hidden. If click "Keyboard" again,soft keyboard will pop up;

4) When the focus is on manual calibration screen, click “OK” to save, click“Back” to cancel and exit. See Figure 4-9.

Soft Keyboard

53

Figure 4-9 Manual Calibration

4.2.8 Automatic Calibration

Enter automatic calibration screen, click "Keyboard", soft keyboard will pop up.If click "Keyboard" again, soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box, move the cursor on the edit box;2) Click soft keyboard, then user can input data through soft keyboard;3) After data input, click automatic calibration screen to move the cursor on

this screen, this moment soft keyboard will be hidden. If click "Keyboard"again, soft keyboard will pop up;

4) When the focus is on automatic calibration screen, click “OK” to save, click“Back” to cancel and exit. See Figure 4-10.

Soft Keyboard

54

Figure 4-10 Automatic Calibration

4.2.9 System Setting

Enter system setting screen, click "Keyboard", soft keyboard will pop up. Ifclick "Keyboard" again, the soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box, move the cursor on the edit box;2) Click soft keyboard, then user can input data through soft keyboard;3) After data input, click system setting screen to move the cursor on this

screen, this moment soft keyboard will be hidden. If click "Keyboard" again,the soft keyboard will pop up;

4) When the focus is on system setting screen, click “OK” to save, click “Back”to cancel and exit. See Figure 4-11.

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55

Figure 4-11 System Setting

4.2.10 Service

Enter service screen, click "Keyboard", then soft keyboard will pop up, if click"Keyboard" again, soft keyboard will be hidden.The procedure of inputting information in edit box is as follows:1) Click target edit box, move the cursor on edit box;2) Click soft keyboard, then user can input data through soft keyboard.3) After data input, click service screen to move the cursor on this screen, this

moment the soft keyboard will be hidden. If click "Keyboard" again, the softkeyboard will pop up.

4) When the focus is on service screen, click “OK” to save, click “Back” tocancel and exit. See Figure 4-12.

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56

Figure 4-12 Service

57

Chapter 5 System Setting

Spincell3 has 4 options to satisfy different requirements of laboratory andclinical diagnostics. Operator can choose different operating modes accordingto actual need.At main menu screen, click “Func”. And then click “Setup”. The Setup menuwill be displayed as Figure 5-1:

Figure 5-1 System Setting

5.1 System Maintenance

Warning: Alarm the errors in analyzer.Auto clean: The analyzer will rinse automatically for each set interval.Auto blank: Select ON in Auto-Blank and click “OK”, the analyzer will run abackground test automatically when startup the analyzer each time.Auto sleep: The analyzer will enter dormancy status if there is no operation fora period of time

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58

Pre-diluent notice: If the Pre-diluent is ON, each time when operator runs asample, the system will prompt that whether or not to run the sample underpre-diluent mode.

5.2 Transfer Setting

In transfer setting as Figure 5-2, operator can setup the port number, baud rate,data bit, stop bit and parity bit of the communication port. The communicationparameters are set before delivery. User should not modify them; otherwisethe data can not be transmitted.Auto trans: the test results will be transmitted from the communication portautomatically.Encoded: hexadecimal and ASCII.NOTE: Transfer setting should be under the guidance of manufacturerengineer.

Figure 5-2 Transfer Setting

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5.3 Print Setting

In Print Setting as Figure 5-3, operator can select printer type, print format,auto print, and input hospital name in “print title”.

Figure 5-3 Print Setting

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60

5.4 Parameter Setting

In Parameter Setting as Figure 5-4, operator can setup the unit of WBC, RBC,PLT, HGB and MCHC, as well as the language and order of parameters.

Figure 5-4 Reference Value Setting

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61

5.5 Date/Time Setting

In Date/Time Setting as Figure 5-5, there are 3 formats of date: YYYY-MM-DD,MM-DD-YYYY, and DD-MM-YYYY. Y indicates Year, M indicates Month, Dindicates Day. The selected date format will be displayed.The resetting of the data format will affect the display format of data on bloodcell analysis screen.

Figure 5-5 Time Setting

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5.6 System Version

User can check the software version, printer software version, printer templateversion, FPGA version, kernel version and library version. If there areproblems, the user can provide this information to manufacturer serviceengineers as Figure 5-6.

Figure5-6 System Version

NOTE: Above system settings have been set up before delivery. User does notneed to reset them generally. If needed, all the operations should under theguidance of manufacturer engineer.

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Chapter 6 Quality Control

Quality control is needed for maintaining the analyzer precision and eliminatingsystem errors. Spincell3 offers four quality control options: L-J QC, X QC,

X -R QC and X-B QC. In following conditions, perform quality control withcontrol materials recommended by manufacturer. After daily start-up procedures completed The reagent lot number changed After calibration After maintenance, or component replacement In accordance with the laboratory or clinical QC protocol In suspicion of parameter value

To ensure the accuracy of result, commercial controls must be handled asfollows: Make sure the controls stored at low temperature and without leakage. Mix the controls according to the manufacturer’s recommendations. Never use controls which are unsealed longer than the period

recommended by manufacturer. Never subject controls to extreme heat or vibration. Perform the high, normal and low controls of new lot, and compare the

values with last lot to verify the difference.

CAUTION: Consider all clinical specimens, controls and calibrators etc. thatcontain human blood or serum as potentially infectious. Wear lab coats, glovesand safety glasses and follow required laboratorial or clinical procedures whenhandling these materials.

6.1 Quality Control Options

(1) L-J QCL-J QC (Levey-Jennings graph) is a simple and visual QC method. Operatorcan draw QC value directly on graph after getting the Mean, SD and CV whichderived from following formulas:

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64

n

XMean

n

ii

1

1)( 2

nMeanX

SD i

100% MeanSDCV

(2) X -R QCIn X -R QC method, X indicates mean value, R indicates range of value. X

graph is mainly used to judge that if the mean value falls in required level. Rgraph is mainly used to judge that if the range of value falls in required level.(3) X QCX QC is the variation of X -R QC; they have the same basic principle. Thedifference is that the control dot in X graph indicates the mean value of twovalues other than a single value. On this foundation, analyzer calculates theMean, SD and CV.(4) X-B QCX-B QC is a moving average method promoted in 1970s. It’s based on theprinciple that RBC count is varied due to the concentration of dilution, humanblood pathology and technical factor, but the hemoglobin content in specificunit is hardly interfered by those preceding factors. According to thischaracteristic, X-B QC is done by detecting the value of MCV, MCH, andMCHC.

6.2 QC Operation

6.2.1 QC Mode Select

In main menu screen, click “Func” and then select ”QC”, dialog box as Figure6-1 will pop up.

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Figure 6-1 QC Mode Select

Spincell3 offers 4 quality control options: L-J QC, X-B QC, X -R QC and X

QC. Select QC mode and click “:OK” to enter corresponding QC interface.

6.2.2 L-J QC

Select L-J QC mode and click “OK” to enter corresponding screen as Figure6-2.

Figure 6-2 L-J QC

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6.2.2.1 L-J QC Edit

In L-J QC screen click “Edit”, enter QC Edit screen as Figure 6-3. There are 3different groups and each group has 3 (low, normal and high) levels. Inputcontrol lot No., expiry date, assay and limit according to the control description.

NOTE: Assay is a standard value which is the reference of quality control. Limitindicates the allowable biased range. but the limit should not be more than40% of assay, or it cannot be saved in database.NOTE: The expiry date format should be MM-DD-YYYY.

Figure 6-3 L-J QC Edit

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6.2.2.2 L-J QC Run

In L-J QC screen click “Run”, enter QC Run screen as Figure 6-4.At QC Run screen, place the control tube under aspiration probe, press RUNkey, the analyzer will start to process control sample. L-J QC needs controlmaterial. If run a background QC, the system will alarm QC result is invalid.Each time runs the L-J QC, “Run Time” on upper right corner of the Run screenwill be updated correspondingly. Lot No. and expiry date can be input in Editscreen.

Figure 6-4 L-J QC Run

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6.2.2.3 L-J QC Review

Spincell3 offers 2 ways to review: QC Graph and QC Data.

(1) L-J QC GraphClick “Back” in QC Run screen or select corresponding QC mode in QC Modedialog box, enter the L-J QC screen to review 12 parameters of QC results.See Figure 6-5.

Figure 6- 5 L-J QC Graph

In L-J QC screen, there are low, normal and high graphs. If select group 1 andlow level to run QC, the control dot will present in low 1 graph. It is also true forother types of QC.

There are function buttons at the bottom of L-J QC screen. Click “Group” tochange the group. Click “Paramr” to change current displayed parameter, forinstance, change from WBC to RBC. Click “Level” to shift the classification linein the same group. Click “Left” or “Right” to shift the classification line in sameQC graph. Click “Print” to print the current data.

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QC results are arranged in graphs according to storage time. The latest is onthe left side and its serial number is 1.

QC graph instruction:1. Graph abscissa indicates QC times, ordinate indicates QC results.2. QC graph can display 31 dots for each parameter.3. Every parameter graph’s upper transverse line means assay plus limit.4. Every parameter graph’s lower transverse line means assay subtractlimit.

5. The 3 values on the left side of each parameter’s graph mean: upper limit —— assay plus limit middle line —— assay lower limit —— assay subtract limit

If the control dot falls in the area between upper and lower lines of thecorresponding graph, it means the dot is in the control range; if not, the dot isnot in the control range.

(2) L-J QC DataIn L-J QC graph screen (see Figure 6-5), click “Data”, operator can review QCdata with 12 parameters as Figure 6-6 shows.

Figure 6-6 L-J QC Data

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In this screen, click “Group” to change group, click “Left” or “Right” to switchpage. Operator could review 31 items at most. Click “Del All” to delete all data.The assay and limit can be input and changed in QC Edit screen.The QC data would be updated after running a new control.

6.2.3 X QC

6.2.3.1 X QC Edit

Select X QC mode in the dialog box as Figure 6-1 shows and then click “OK”to enter corresponding screen. Click “Edit”, enter X QC Edit screen as Figure6-7.

Figure 6-7 X QC Edit

In X QC Edit screen, click “Group” to switch group; click “Del” to delete thecurrent assay and limit; click “OK” to save the current assay and limit; click“Back” to exit X QC Edit screen.

NOTE: The same as L-J QC, the limit should not be more than 40% of assay,or it cannot be saved in database.

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NOTE: The expiry date format should be MM-DD-YYYY.

6.2.3.2 X QC Run

In X QC screen click “Run”, enter QC Run screen as Figure 6-8.At this screen, system displays two control results and calculates the meanvalue automatically. The assay is input in X QC Edit screen. Click “Group” toswitch group; click “Back” to exit.

Figure 6-8 X QC Run

In X QC Run screen, place the control tube under aspiration probe, pressRUN key, the analyzer will start to process control sample. If the current groupassay is empty, the system will display “No QC reference data, cannot performQC running”. At this time, operator should back to the Edit screen to inputassay and limit.

X QC needs control material. If run a background QC, the system will alarmQC result is invalid.

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6.2.3.3 X QC Review

Spincell3 offers 2 ways to review: QC Graph and QC Data.

(1) X QC GraphClick “Back” in QC Run screen or select corresponding QC mode in QC Modedialog box, enter the X QC screen as Figure 6-9 shows. Operator can review12 parameters of QC results. As a difference to L-J QC Graph, the dot on X

QC Graph indicates the mean value of 2 QC results.

Figure 6-9 X QC Graph

In X QC screen, there are low, normal and high graphs. If select group 1 andlow level to run QC, the control dot will present in low 1 graph. It is also true forother types of QC.

There are function buttons at the bottom of X QC screen. Click “Group” tochange the group. Click “Param” to change current displayed parameter, forinstance, change from WBC to RBC. Click “Level” to shift the classification linein the same group. Click “Left” or “Right” to shift the classification line in sameQC graph. Click “Print” to print the current data.

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QC graph instruction:1. Graph abscissa indicates QC run times, ordinate indicates QC results.2. QC graph can display 31 dots for each parameter.3. Every parameter graph’s upper transverse line means assay plus limit.4. Every parameter graph’s lower transverse line means assay subtractlimit.

5. The 3 values on the left side of parameter graph mean: upper limit —— assay plus limit middle line —— assay lower limit —— assay subtract limit

If the control dot falls in the area between upper and lower lines of thecorresponding graph, it means the dot is in the control range; if not, it is not inthe control range.

(2) X QC DataIn L-J QC graph screen (see Figure 6-9), click “Data”, operator can review QCdata with 12 parameters as Figure 6-10 shows.In this screen, click “Group” to change group, click “Left” or “Right” to switchpage. Operator could review 31 items data at most. Click “DelAll” to delete allthe data.The assay and limit can be input and changed in QC Edit screen.The QC data will be updated after running QC twice. At the same time, themean value will be displayed.

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Figure 6- 10 X QC Data

6.2.4 X -R QC

6.2.4.1 X -R QC Run

On X -R QC screen click “Run”, enter QC Run screen as Figure 6-11.At this screen, system displays two control results and calculates the meanvalue and range automatically. Click “Group” to switch group; click “Back” toexit.

X -R QC needs control material. If run a background QC, the system will alarmQC result is invalid

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Figure 6-11 X -R QC Run

6.2.4.2 X -R QC Review

Spincell3 offers two ways to review: QC Graph and QC Data.(1) X -R QC GraphClick “Back” on QC Run screen or select corresponding QC mode in QC Modedialog box, enter the X -R QC screen as Figure 6-12 shows. Operator canreview QC results with 12 parameters. The dot on X -R QC Graph indicatesmean value or range of 2 QC results. The system cannot display low, normaland high control graphs simultaneously in one screen, please click “Group” toswitch.

X -R QC graph is divided into 2 parts: X graph and R graph. X graphdisplays mean value dots while the R graph displays range dots.There are function buttons at the bottom of X -R QC screen. Click “Group” tochange the group. Click “Param” to change current displayed parameter, forinstance, change from WBC to RBC. Click “Level” to shift the classification linebetween X and R graphs. Click “Left” or “Right” to shift the classification linein X or R graph. Click “Print” to print the current data.

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Figure 6-12 X -R QC Graph


X graph instruction:1. Graph abscissa indicates QC run times, ordinate indicates QC results.2. QC graph can display 31 dots for each parameter.3. Every parameter graph’s middle transverse line indicates X —the

mean value of QC results.4. Every parameter graph’s upper transverse line means X upper limit＝ X ＋A×R.

5. Every parameter graph’s lower transverse line means X lower limit＝

X －A×R.6. The 3 values on the left side of parameter graph mean:

upper limit —— X upper limit＝ X ＋A×R middle line —— X

lower limit —— X lower limit＝ X －A×R

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R graph instruction:1. Graph abscissa indicates QC run times, ordinate indicates QC result.2. QC graph can display 31 dots for each parameter.3. Every parameter graph’s middle transverse line indicates R—the mean

value of QC result range.4. Every parameter graph’s upper transverse line means R upper limit＝

B×R.5. Every parameter graph’s lower transverse line means R lower limit＝

C×R.6. The 3 values on the left side of parameter graph mean:

upper limit —— R upper limit＝B×R middle line —— R lower limit —— R lower limit＝C×R

If the control dot falls in the area between upper and lower lines of thecorresponding graph, it means the dot is in the control range; if not, the dot isnot in the control range.

(2) X -R QC DataIn X -R QC Graph screen (See Figure 6-12), click “Data”, operator can reviewQC data with 12 parameters as Figure 6-13 shows.On this screen, click “Group” to change group, click “Left” or “Right” to switchpage. Operator could review 31 items at most. Click “DelAll” to delete all thedata.

X -R QC data screen can only display three control results, and each onecontains mean and range. The first two lists on this screen are total mean andaverage range. See Figure 6-13.The QC data would be updated after running new controls twice.

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Figure 6-13 X -R QC Data

6.2.5 X-B QC

6.2.5.1 X-B QC Edit

X-B QC Edit is different to others, with which the system only edits threeparameters: MCV, MCH, and MCHC.

Select X-B QC mode in the dialog box as Figure 6-1 shows. click “OK” to enterthe X-B QC screen, then click “Edit” to enter X-B QC Edit screen. See Figure6-14.

At Edit screen, click “Del” to delete current assay and limit; click “OK” to savethem; click “Back” to exit.

NOTE: Assay is a standard value which is the reference of quality control. Limitindicates the allowable biased range. but the limit should not be more than40% of assay, or it cannot be saved in database.NOTE: The expiry date format should be MM-DD-YYYY.

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Figure 6-14 X-B QC Edit

6.2.5.2 X-B QC Run

X-B QC is a moving average method, which needs no control material.Click “Run” on the X-B QC screen to enter the X-B QC Run screen as Figure6-15. “X-BQC Run” is for selecting to run X-B QC or not. “Sample num” is forselecting the quantity of samples for each group. For example, if “X-BQC Run”is ON and “Sample num” is 20, the subsequent 20 counts will be X-B QC.Click “OK” to save the current selections.After 20 times of count completed, back to the Run screen and click “COUNT”,system will calculate the QC results and display them in QC Graph and QCData.

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Figure 6-15 X-B QC Run

6.2.5.3 X-B QC Review

Spincell3 offers two ways to review QC result: QC graph and QC data.

(1) X-B QC GraphClick “Back” on QC Run screen or select corresponding QC mode in QC Modedialog box to enter the X-B QC screen as Figure 6-16. Operator can review QCresults with 3 parameters. After the count of group samples completed, theresults of MCV, MCH, MCHC will be depicted as dots on the graph. Forexample, the “X-BQC Run” is ON and “Sample num” is 20, then after 20counts, the system will calculate a X-B QC value and display a correspondingcontrol dot on the graph.X-B QC screen can display graphs of MCV, MCH and MCHC. And the graphswill be updated after each QC counting.The function buttons are basically as the same as other QCs with additional“Pgpre” and “Pgnex”.QC results are arranged in graphs according to storage time. The latest is onthe left side and its serial number is 1.

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81

X-B QC Graph instruction:1. Graph abscissa indicates QC run times, ordinate indicates QC results.2. QC graph can display 31 dots for each parameter..3. Every parameter graph’s upper transverse line means assay plus limit.4. Every parameter graph’s lower transverse line means assay subtract

limit.5. The 3 values on the left side of parameter graph mean:

upper limit —— assay plus limit middle line —— assay lower limit —— assay subtract limit

If the control dot falls in the area between upper and lower lines of thecorresponding graph, it means the dot is under control range; if not, it is notunder control range. See Figure 6-16.

Figure 6-16 X-B QC Graph

(2) X-B QC DataIn the screen as Figure 6-16, click “Data”, operator can review 3 parametersQC data as Figure 6-17 shows. Click “Left” or “Right” to switch page, operatorcould review 31 items at most. Click “DelAll” to delete all the data. The Assayand Limit can be input and changed in QC Edit screen.

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The QC data would be updated after running a new control.

Figure 6-17 X-B QC Data

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Chapter 7 Calibration

To ensure analyzer’s precision and obtain reliable test results, the parameters(WBC, RBC, PLT, HGB, and MCV) should be calibrated in the followingsituations:1) Working environment changes greatly.2) One or multiple parameters’ test results are moving.3) Any major component that could affect the measurement is replaced.4) Requirement of clinic or laboratory.5) The reagent has been replaced.6) The analyzer presents deviation when running quality control.

MCV, HCT are relative parameters to each other, thus one can be obtainedfrom given value of the other. Only MCV will be calibrated by the analyzer.Usually the manufacturer will give the reference value for MCV, HCT at thesame time.

CAUTION: Consider all clinical specimens, controls and calibrators etc. thatcontain human blood or serum as potentially infectious. Wear lab coats, glovesand safety glasses and follow required laboratorial or clinical procedures whenhandling these materials.CAUTION: Only calibrators recommended by manufacturer can be used toaccomplish the calibration.CAUTION: Follow the recommendations provided by manufacturer to store thecalibrators.CAUTION: Check if the container is broken or cracked before using thecalibrator.CAUTION: Make sure the calibrators are brought to room temperature andwell mixed slowly before use.CAUTION: Make sure the calibrators are within the expiry date.CAUTION: Make sure the analyzer has no problem before calibration.CAUTION: Never apply the test data to laboratory or clinic use unless allparameters are accurately calibrated.

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84

7.1 Preparation for Calibration

Before calibration, inspect the analyzer as follow:1) Ensure the adequate reagents are in shelf life and uncontaminated.2) Run a background test and make sure the results are qualified.3) The analyzer is fault –free.4) Verify the precision of the analyzer. At main menu screen, run normal

control 11 times, query the results from second to eleventh in Queryscreen, make sure the CVs are within the prescribed limits in Table 7-1.

Table 7-1 Precision

Parameter CV Range

WBC ≤2.0% 4.0×109/L ~ 15.0×109/L

RBC ≤1.5% 3.00×1012/L ~ 6.00×1012/L

HGB ≤1.5% 100 g/L ~ 180g/L

HCT/

MCV

≤1.0%

≤0.5%

35% ~ 50%

76fL ~ 110fL

PLT ≤4.0% 100×109/L ~ 500×109/L

5) Running with high control in triplicate, then using diluent instead of highcontrol to test 3 times continuously. Carryover(%) is calculated from thefollowing formula. Results must conform to Table 7-2.

Table 7-2 Carryover

Parameter Result

WBC ≤0.5%

RBC ≤0.5%

HGB ≤0.5%

HCT ≤0.5%

PLT ≤0.5%

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85

NOTE: If whole blood and capillary blood are both used in daily work,calibration should be done after confirming the sampling mode.NOTE: After confirming the mode, all test should be done in the samemode.NOTE: If any malfunction occurs during measurement, the test results areinvalid. Repeat the measurement after troubleshooting.

7.2 Manual Calibration

At main menu screen, click “Cal” to enter System Calibration screen. Choose“manual Cal”, click “OK” to enter manual calibration interface.Input assay and values, then click “New Cal” button, the system will calculatethe new calibrated value automatically and the date will be updatedsimultaneously. See Figure 7-1:

Figure 7-1 Manual Calibration

Click “OK” to save the new calibration values.Click “Print” to print the new calibration values.Click “Back” to exit the System Cal.

app:ds:simultaneously

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86

Counting principle of new calibration value: New calibration value=(assay/mean value) ×former calibration value If the new calibration value<70%, consider it equals to 70%; if the new

calibration value>130%, consider it equals to 130%.

NOTE: Calibration coefficient is allowed in the range of 70%~130%, if the testvalue exceed the limit, this critical value will be selected as the new coefficientfor calibration.NOTE: Analyzer can calibrate a certain parameter or all parameters of WBC,RBC, HGB, MCV, MPV, RDW_CV, RDW_SD, PLT and PDW.CAUTION: Data will be lost if exit without pressing “OK” to save.

7.3 Auto Calibration

At main menu screen, click “Cal” to enter System Calibration screen, Choose“Auto Cal”, click “OK” to enter auto calibration interface. See Figure 7-2.

Figure 7-2 Automatic Calibration

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87

At Auto Calibration Mode, input assay then place the calibrator tube under theaspiration probe, press RUN key, the analyzer starts to count and thendisplays the results in Value 1 to Value 4 according to the sequence of 4counts.Analyzer cannot count or display the test value in following conditions:1) After counting for 5 times, press RUN key, analyzer will prompt that there is

no space to process calibration count.2) If the precision of test result is abnormal, analyzer will prompt “data is

abnormal, please re-counting”.3) After each counting, analyzer will calculate a new calibration value

according to reference value and test result and update the calibrationdate.

Click “Print” to print the new calibration values.

Counting principle of new calibration value:

Mean of the new calibration value：

n

ii=1X

Mean=n

New calibration value=(assay/mean value) ×former calibration value If the new calibration value<70%, consider it equals to 70%; if the new

calibration value>130%, consider it equals to 130%.

NOTE: Click “OK” after counting and then system will save the values. Click“Back” without clicking “OK”, the value will not be saved.

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Chapter 8 Parameter Limit

To monitor abnormal blood sample measurement, it is essential for theoperator to setup normal ranges of the parameter according to laboratorial orclinical requirement. Prompt or indication will be given if the test values exceedthe range. The limits of 21 parameters are discussed in this chapter, anyresults exceeding the range will be marked with H (High) or L (Low). H meansthe results are higher than the upper limits, while L means the results are lowerthan the lower limits.CAUTION: The shift in parameter limit may cause changes in abnormalindication of hematology index. Please confirm the necessity for changing.

8.1 Limit Review

At Limit Setting screen, operator can input proper parameter limits or usedefault limits. Default limits are different depending on patient group. Figure8-1 depicts General group limits. Figure 8-2 depicts User 1 group limits

Figure 8-1 General Group

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89

Figure 8-2 User 1 Group

Click “Def”, the system prompts the operator to decide whether to recover allthe default limits. Select “Yes” to recover parameters of all groups to defaultlimits; select “No” to exit. See Figure 8-3.

Figure 8-3 Recover to Default Limit

Click “OK” to save current default limits which will be displayed when operatorenter Limit Setting screen again.

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90

8.2 Limit Modification

Operate as follows to modify the parameter limit:1) At main menu screen, click “Func”, then click “Limit” to enter limit setting

screen.2) Click “Group”, the screen displays the lower and upper limits of parameters

in current group.3) Select the lower or upper limit of the parameter that operator wanted to

modify, delete the former limit by Backspace key on keyboard, then inputthe new lower or upper limit.

4) Click “OK”, and then the dialog box as Figure 8-4 shows will pop up, select“Yes” or “No” to save the modification or not.

Figure 8- 4 Save the New Setup

8.3 Print

Click “Print”, then system will print out limits of all groups in list formautomatically.

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Chapter 9 Maintenance

Routine care and regular maintenance are essential to keep optimalperformance, minimize system problems and prolong the life span. Proceduresand instructions of preventive maintenance are discussed in this chapter. Moreinformation is available at manufacturer Customer Support Centre.Preventive maintenance should be performed periodically. Pertinentmaintenance is also included in this Chapter according to actual requirement.

WARNING: A normative maintenance criterion should be performed strictly toavoid analyzer failure.WARNING: Perform individual protection before instrument maintenance, suchas wear glove, respirator and lab coat etc.

9.1 Daily Maintenance

Spincell3 is designed with daily auto-maintenance program. As shown inFigure 9-1, operator can select the auto-clean time to maintain the system.Please refer to Table 9-1 for time setting.

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Figure 9-1 System Maintenance Setting

Table 9-1 Time Setting

9.2

Weekly Maintenance

9.2.1 Surface Maintenance

Clean the smudge on the surface of analyzer, especially the spilled blood onthe aspiration probe and surrounding, to remove the protein buildup or debrisand reduce the possibility of a blockage. Wipe the outside of the probe andsurrounding with gauze soaked by litmusless detergent before cleaning otherparts.

Run time (hour) Time for auto-clean (hour)> 8 4

4< Run time<8 4

Run time< 4 2Time for auto-clean should be reduced by each year.

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93

CAUTION: Never use corrosive acids, alkali or volatile organic solvent (suchas acetone, aether and chloroforms etc.) to clean the outside of the analyzer.Only litmusless detergent is allowed.

9.3 Monthly Maintenance

Monthly maintenance mainly aims at mechanism maintenance, includinglubricant motor shaft, X, Y leaders of sampling organ etc..

NOTE: Ensure the power of host is off before monthly maintenance.

9.4 System Maintenance

At main menu screen select “Func”, then select “Maint” to enter the screen asFigure 9-2.

Figure 9-2 System Maintenance

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94

Spincell3 offers 10 maintenance functions as follows: Cauterize Aperture Flush Aperture Drain Cups Rinse Cups Rinse Fluidics Prime Lyse Prime Diluent Prime Detergent Prime Fluidics Prepare Shipping

9.4.1 Cauterize Aperture

Cauterize Aperture helps to prevent and remove aperture clog. Procedure is asfollows:

1. Select “Cauterize Aperture” at Maintain screen.2. The analyzer starts to perform the function and display the progress

bar at the bottom of the screen.3. After completing, system will back to the Maintain screen.

9.4.2 Flush Aperture

Flush Aperture helps to prevent and remove aperture clog associating withCauterize Aperture. The procedure is as follows:

1. Select “Flush Aperture” in Maintain screen.2. The analyzer starts to perform the function and display the progress


9.4.3 Drain Cups

Perform this operation to drain diluent out of WBC and RBC cups.

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95

9.4.4 Rinse Cups

Perform this operation to rinse the aperture to prevent blockage when countingtime is too long. The procedure is as follows:

1. Select “Rinse Cups” in Maintain screen.2. The analyzer starts to perform the function and display the progress


9.4.5 Rinse Fluidics

CAUTION: Consider all clinical specimens, controls and calibrators etc. thatcontain human blood or serum as potentially infectious. Wear lab coats, glovesand safety glasses and follow required laboratorial or clinical procedures whenhandling these materials.CAUTION: As probe detergent is corrosive, operator should wear lab coats,gloves and follow required laboratory operation procedures.

Probe detergent is a kind of alkalescence detergent. Prime Fluidics is to rinseWBC and RBC cups as well as related tubings with probe detergent. If theanalyzer keeps on working day by day, perform Prime Fluidics every 3 days; Ifnot, perform this operation every week.The procedure is as follows:1) Place the probe detergent container under the aspiration probe. Select

“Prime Fluidics” at Maintain screen, then the dialogue box as Figure 9-3will pop up, select “Yes” to aspirate the detergent, select “No” to back toMaintain screen.

Figure 9-3 Prime Fluidics Dialogue Box

2) Remove the detergent after the probe retracting back. Analyzer starts toperform the function and display progress bar at the bottom of the screen.

Maintenance

96

3) After several seconds, the dialogue box as Figure 9-4 will pop up, put theprobe detergent container under the aspiration probe again then click“OK”.

Figure 9-4 Aspirate Detergent Dialogue Box

4) After completing, system will back to the Maintain screen.

9.4.6 Prime Lyse

CAUTION: Consider all clinical specimens, controls and calibrators etc. thatcontain human blood or serum as potentially infectious. Wear lab coats, glovesand safety glasses and follow required laboratorial or clinical procedures whenhandling these materials.NOTE: Keep the lyse still for a certain time to ensure it stable.NOTE: After replacing diluent, detergent or lyse, perform background test tomake sure the background values are in a acceptable range.

Perform this operation in the following conditions, There are bubbles in lyse tubing. Lyse have been contaminated. Replace lyse.The procedure is as follows:1) Select “Prime Lyse” in Maintain screen.2) Analyzer starts to perform the function and display the progress bar at the

bottom of the screen.3) After completing, system will back to the Maintain screen.

Maintenance

97

9.4.7 Prime Diluent

CAUTION: Consider all clinical specimens, controls and calibrators etc. thatcontain human blood or serum as potentially infectious. Wear lab coats, glovesand safety glasses and follow required laboratorial or clinical procedures whenhandling these materials.NOTE: Keep the diluent still for a certain time to ensure it stable.NOTE: After replacing diluent, detergent or lyse, perform background test tomake sure the background values are in a acceptable range.

Perform this operation in the following conditions, There are bubbles in diluent tubing. Diluent have been contaminated. Replace diluent.The procedure is as follows:1) Select “Prime Diluent” in Maintain screen.2) The analyzer starts to perform the function and display the progress bar at

the bottom of the screen.3) After completing, system will back to the Maintain screen.

9.4.8 Prime Detergent

CAUTION: Consider all specimens, controls and calibrators etc. that containhuman blood or serum as potentially infectious. Wear lab coats, gloves andsafety glasses and follow required laboratorial or clinical procedures whenhandling these materials.NOTE: Keep the detergent still for a certain time to ensure it stable.NOTE: After replacing diluent, detergent or lyse, perform background test tomake sure the background values are in acceptable range.

In the following conditions, perform this operation: There are bubbles in detergent tubing. Detergent have been contaminated. Replace a new detergent.

Maintenance

98

The procedure is as follows:1) Select “Prime Detergent” in Maintain screen.2) The analyzer starts to perform the function and display the progress bar at


9.4.9 Prime Fluidics

If background test results are abnormal or clog, bubbles faults are prompted,perform this operation to rinse the apertures and cups. The procedure is asfollows:1) Select “Rinse Fluidics” in Maintain screen.2) The analyzer starts to perform the function and display the progress bar at


9.4.10 Prepare Shipping

Perform this function before shipping or leave the analyzer unused for a longtime. Please refer to section 9.5 for details. The procedure is as follows:1) Select “Prepare Shipping” in Maintain screen, then the dialogue box as

Figure 9-5 will pop up, select “Yes” to perform this operation, select “No” toback to Maintain screen.

Figure 9-5 Drain Dialogue Box

2) The analyzer starts to perform the function and display the progress bar atthe bottom of the screen.

3) After completing, system will back to the Maintain screen.

Maintenance

99

9.5 Maintenance before Shipping

If the analyzer is left unused for more than 3 months or being shipped, pleaseperform following operations for maintenance:1) Take out the diluent inlet tube which is connecting with diluent port on the

rear panel from waste container, discharge the remaining diluient in tube.2) Take out the lyse inlet tube which is connecting with lyse port on the rear

panel from waste container, discharge the remaining lyse in tube.3) Take out the detergent inlet tube which is connecting with detergent port on

the rear panel from waste container, discharge the remaining detergent intube.

4) Store the remaining reagents according to instructions and avoidsupercooling and overheating. Operator should establish and conform toeffective storage measures to prevent reagent from degeneration,misusage or misdrinking.

5) Keep the diluent, lyse and detergent inlet tubes hanging in the air.6) At main menu screen, click “Prime” several times until the top left corner of

the screen present “No Diluent”, “No Lyse”, “No Detergent”, then Click“Prime” once again.

7) Insert diluent, lyse and detergent tubes into distilled water.8) At main menu screen, click “Func”→“Maint”→”Prepare Shipping” to inter

the screen as Figure 9-6 shows.

Maintenance

100

Figure 9-6 Select Prepare Shipping

1) After completed, take out the diluent, lyse and detergent tubes fromdistilled water and click “Prepare Shipping” again to drain the reagent intubes.

2) At main menu screen, click “Exit”, “Thank you, now turn off power” willappear to instruct the operator to turn off the power switch on the rearpanel.

3) Pull out outlet tube from the rear panel, clean it with distilled water andsave it with plastic bag after dry by airing.

4) Cover the connectors of DILUENT, LYSE, DETERGENT and WASTE onthe rear panel with caps which are taken out at initial installation.

5) Disconnect the power cord of analyzer and save it in plastic bag. Place theanalyzer and components in plastic bags into the shipping box.

101

Chapter 10 Service

Routine care and regular maintenance are essential to keep optimalperformance, minimize system problems and prolong the life span.This chapter introduces the Service function, with which operator may monitorthe system status, valve and motor status etc.. More information is available atmanufacturer Customer Support Centre.

CAUTION: Incorrect maintenance may lead to impairment of analyzer. Pleasemaintain the analyzer according to this manual.NOTE: If there is any problem which is not discussed in the manual, pleasecontact the manufacturer Customer Support Centre.

10.1 System Check

Click “Func” at main menu screen, select “Sev”, input “2006” in the pop-updialog box to enter the System Check screen.

10.1.1 System Status Check

The System Status Check screen presents the current status information forexample temperature, constant-current source voltage, 5V voltage, HGB zerovoltage, HGB background voltage, WBC stenopaic voltage, RBC stenopaicetc.. See Figure 10-1.

Service

102

Figure 10-1 System Status Check

NOTE: At System Status Check screen, operator can view the temperature,vacuum etc. that mention above, but cannot modify.

Click “Back” to return to the main menu screen.

10.1.2 Valve Check

At Valve Check screen (see Figure 10-2), operator can check if the valves arein normal condition.

Service

103

Figure 10-2 Valve Check

At Valve Check screen, click valve buttons, the corresponding results will bedisplayed in result list. See Figure 10-3.

Service

104

Figure 10-3 Valve Check Result

Click "Back" to return to the main interface of the system.

10.1.3 Motor Check

At Motor Check screen, operator can check if the motors are in normalcondition. At the screen, click motor buttons, the corresponding result will bedisplayed in result list. See Figure 10-4.

Service

105

Figure 10-4 Motor Check

Click "Back" to return to the main interface of the system.

10.2 System Log

Click “Func” at main menu screen, select “Sev”, input “6666” in the pop-updialog box to enter the System Log screen as Figure 10-5 shows:

Service

106

Figure 10-5 System Log

10.2.1 System Log Query Mode

Data QueryChoose the begin date and end date on System Log screen, then click “Rev”,the query results will be displayed in the list box. As shown in Figure 10-6.

Service

107

Figure 10-6 Date Query

Event QueryOn System Log screen, cancel Date option in check box in top left corner, thencheck Event query mode, select intended event in dropdown options. Click“Rev”, results will be displayed in list as Figure 10-7 and Figure 10-8.

Service

108

Figure 10-7 Event Query

Figure 10-8 Event Query

Service

109

After getting the query results, operator can perform following operations:1) The number of total pages and current page number will be automatically

displayed on the list box.2) If query logs are in a large quantity and cannot be displayed in one page,

press Pgprv and Pgnex buttons to view the results in previous or nextpage.

3) Select a record, click "Del.", then it will be deleted.4) Press "DelAll", all the records will be deleted.5) Click "Back" to return to the main screen.

110

Chapter 11 Troubleshooting

This Chapter gives instructions for identifying, troubleshooting and correctingfaults. If malfunction cannot be solved according to this chapter or moreinformation is needed, please contact manufacturer Customer Support Centre.

11.1 Troubleshooting Guidance

The Troubleshooting Guidance is designed to assist the operator to identifyand resolve analyzer faults. It also gives instructions on obtaining technicalassistance from manufacturer Customer Support Centre. The first step is tounderstand the normal operation and preventive maintenance of analyzer.Rich experience is essential for troubleshooting. Logical troubleshooting canbe divided into 3 steps:

Step 1 Fault Identification:Operator should have the ability to identify fault cause and understand properoperation well. Accurate fault identification is essential for troubleshooting.

Step 2 Fault Isolation:Fault Isolation means further classifying the problem. Analyzer faults aregenerally divided into three categories:

a) Faults relate to hardwareb) Faults relate to softwarec) Test faults relate to sample analysis

Hardware and software faults can only be corrected by a manufacturerauthorized engineer. While the test faults relate to sample analysis can becorrected by operator with assistance from manufacturer engineers.

Step 3 Corrective Action:Corrective Action means taking appropriate action to correct the fault. Ifoperator is able to correct faults with or without technical assistance frommanufacturer engineer, time spent can be reduced greatly.

Troubleshooting

111

11.2 Obtaining Technical Assistance

If technical assistance is needed, please contact manufacturer CustomerSupport Centre. Refer to Copyright and Declaration for Tel. number and faxnumber User should provide detailed and clear faults description.Requirements are as follows:a) Model;b) Serial number and version number;c) Description of fault and operating environment (for example, the fault

happened in which screen and status);d) Lot numbers of reagents (lyse, diluent and detergent etc.);e) Related data and reportFamiliar faults and corrective actions are also given in this Chapter. Operatorcan identify the fault cause according to warning information and correct thefault follow Troubleshooting Guide.

11.3 Troubleshooting

Familiar faults and corrective actions are listed as follows. If faults still cannotbe corrected according to this chapter, or more technical assistance is needed,please contact with manufacturer Customer Support Centre.

Troubleshooting

112

11.3.1 Faults Relate to Reagents

Fault Probable Cause Corrective Action

Lyse Empty

Lyse has beenused up or lyseinlet tube isblocked.

1. Check that if the lyse has been used up;2. Perform “Func” → “Maintain” →”Prime Lyse”;3. If fault still occurs, please contact with

manufacturer.

Diluent EmptyDiluent has beenused up.

1. Check that if the diluent has been used up;2. Perform “Func” → “Maintain” →”Prime Diluent”;3. If fault still occurs, please contact with

manufacturer.

DetergentEmpty

Detergent hasbeen used up;

1. Check that if the detergent has been used up;2. Perform “Func” → “Maintain” →”Prime Detergent”;3. If fault still occurs, please contact with

manufacturer.

Waste FullWaste container isfull or waste sensoris in fault.

1. Check that if the waste is full;2. Check that if the sensor is short circuit;3. If fault still occurs, please contact with

manufacturer.

11.3.2 Faults Relate to Vacuum


Low Vacuum

Pressure ofvacuum chamberdid not reachstandard value intime.

1. Click “Sev”, input password “2006” to enterSystem Check screen, ensure the vacuum itemsare in normal condition.

2. If fault still occurs, please contact withmanufacturer.

Troubleshooting

113

11.3.3 Faults Relate to 5V Voltage


5V VoltageProblem

Power supplymodule isabnormal.

1. Click “Sev”, input password “2006” to enterSystem Check screen, ensure the 5V Voltage isin normal condition.


11.3.4 Faults Relate to Test Results


HighBackgroundValue

Diluent iscontaminated oroverdue; diluentstube or cups arecontaminated.

1. Check that if the diluent is overdue orcontaminated；

2. Enter Maintain screen and perform “RinseFluidics”；

3. If fault sill occurs, Perform Prime Fluidics atMaintain screen with probe detergent. Run abackground test again to check if the fault hadbeen cleaned;


HGBInaccuracy

HGB backgroundvoltage jump

1. Click “Sev”, input password “2006” to enterSystem Check screen, check “HGB_BACK” and“HGB_ZERO”;

2. If “HGB_BACK” and “HGB_ZERO” are out ofrange, contact with manufacturer. Readjust thevoltage with professional assistance.

Troubleshooting

114

WBC Clogor

RBC Clog

Ruby aperture isclogged; WBCcounting time isabnormal; solenoidvalve problem

1. Perform “Cauterize Aperture” or “Flush Aperture”in Maintain screen, and then run a backgroundtest to check the counting time;.

2. If fault still occurs, perform Prime Fluidics inMaintain screen;


WBC bubbleor

RBC bubble

1. Diluent ordetergent hasbeen used up;

2. Loose reagenttubing connectionleads to leakage.

1. Check if diluent or detergent has been used up;2. Check the reagent tubing connection, prevent

leakage;3. Perform Rinse Fluidics in Maintain;4. If fault still occurs, please contact with

manufacturer.

11.3.5 Faults Relate to Hardware


Motorsounds isabnormal.

1. Motor connectingwire is loose;

2. Travel switchproblem;

3. Motor problem;4. Motor drive circuitproblem

1. Click “Sev”, input password “2006” to enterSystem Check screen, ensure the motor items arein a normal condition;


Countingtime is toolong or nocountingtime.

1. Ruby aperture isclogged;

2. Valve is notworking..

1. If the fault still occurs after eliminating apertureclog, click “Sev”, input password “2006” to enterSystem Check screen, ensure all valves are in anormal condition.


Troubleshooting

115

11.3.6 Faults Relate to Temperature


Temperatureis abnormal

Temperature isabnormal ortemperature sensorhas problems.

1. Click “Sev”, input password “2006” to enterSystem Check screen, verify the temperature inSystem Status Check.

2. If working temperature is out the acceptablerange: 15 ℃ -30 ℃ , improve workingenvironment to meet the requirement;


116

Chapter 12 Precautions, Limitations and Hazards

Improper operation will lead to errors; even damage to operator or otherpeople. Therefore, a criterion should be designed to perfect the serviceconditions to reach the optimal performance.

12.1 Limitations

1) The instrument is designed for in vitro diagnostic use.2) All the relevant personnel for operation, shipment, installation or

maintenance etc. should strictly follow the requirements in this manual,otherwise non-standard operation may lead to fault and user will lose theright of free service.

3) Using reagents, controls and calibrators which is not specified bymanufacturer may lead to faults even accident. User cannot get freeservice from manufacturer in this condition.

4) Repairs can only be done with the permission of manufacturer. Pleaseusing components specified by manufacturer for replacement. For theproblems derived from illegal operation, manufacturer will not offer freeservice.

5) Please follow the recommended maintenance schedules and proceduresoutlined in Chapter 9. Fail to comply with the requirement will shorten thelife span and affect the test results even cause accident. manufacturer willnot offer free service in this condition.

12.2 Location Limitations

1) Initial installation should be done by a qualified engineer authorized bymanufacturer.

2) Place the analyzer on a stable and level operating platform. Please payattention to the following: Away from direct sunlight. Away from the air outlet to avoid temperature extremes. Away from drying oven, centrifuge, x-ray equipment, copiers or

Precautions, Limitations and Hazards

117

ultrasonic cleaner.3) Place the reagent containers at the same level of the analyzer.4) The installation area of analyzer and reagents is 2m2. Please keeping at

least 40cm distance from surrounding objects to ensure ventilation.Adequate space should be left for maintenance and service.

5) Please perform following operations prior to initial use: Ensure liquid connection is proper and stable. Ensure tubes are not bending. Ensure reagents are flowing fluently. Ensure wastes are being drained into a suitable waste container.

6) Do not disconnect any electrical connection while power is ON. Ensure theanalyzer is grounded well to prevent electrical interference and ensuresafety.

CAUTION: Serviceman who is not authorized by manufacturer or unqualifiedis not allowed to remove the screws on the shell. manufacturer is not liable forthe serious consequences caused by illegal operation.

12.3 Personal Protection and Infection Control

1) Follow required laboratorial or clinical procedures during daily operation ormaintenance. Wear gloves, lab clothing and safety glasses to avoid directcontact with the samples.

2) Consider all clinical specimens, controls and calibrators etc. that containhuman blood or serum as potentially infectious. Wear standard laboratorialclothing, gloves and safety glasses and follow required laboratorial orclinical procedures when handling these materials. Do not smoke, eat ordrink in working area. Do not suck or blow the tubing.

3) Blood samples and waste have potential biological and chemical hazard,thus operator should handle with care. Follow relevant local regulations toclean, dispose and discharge the waste.

4) Follow directions to store reagent, calibrators and controls. Reagentsshould be kept away from temperature extremes. Customer should set upand execute effective safekeeping measurement to prevent expired use,deterioration, misapplication or ingestion.

Precautions, Limitations and Hazards

118

CAUTION: Reagent will freeze if being stored below 0℃. Disuse the reagent ifis frozen.CAUTION: Keep away from direct sunlight. Seal the cap of the container andminimize the pore size to avoid evaporation and contamination.

119

Appendix A: Instrument Specifications

Dimension and WeightDimension:530mm(L)×330mm(W)×460mm(H)Weight: 23kg

Transport and Storage SpecificationsTemperature: -10℃~55℃Relative Humidity: ≤95%RHBarometric Pressure: 50kPa~106kPa

Environmental RequirementsTemperature: 15℃~35℃Relative Humidity: ≤90%RHBarometric Pressure:60kPa~106kPa

Power SpecificationsPower Supply: AC 100V～240VFrequency: 50/60HzPower: 100VA-180 VAFuse: 250V/3A

Scope of ApplicationVenous blood, peripheral blood of human being

Appearance SpecificationsDisplay: 10.4-inch LCDLanguage: English/Simplified ChineseParameter: 21 parameters and 3 histogramsIndicator: Status Indicators/Work Mode IndicatorsSystem Alert: Alert message/Alert beepPorts: Power Receptacle

Printer PortsRS-232 PortPS/2 PortUSB Ports

Recorder SpecificationsRecorder Width: 48mmPaper width: 57.5mmPaper Roll Diameter: 53mmPrint Speed: 25mm/s

Appendix A

120

Sample VolumeWhole Blood Mode for Venous Blood: Venous Blood 10 μLPre-diluent Mode for Peripheral Blood: Capillary Blood 20 μLWhole Blood Mode for Peripheral Blood: Capillary Blood 10 μLNOTICE: Sample dosages can be different according to analyzer version.

Reagent Volume for Single SampleDiluent: 31mLDetergent: 8mLLyse: 0.7mLNOTICE: Sample dosages can be different according to analyzer version.

Background ResultsWBC≤0.2×109/L；RBC≤0.02×1012/L；HGB≤1g/L；PLT≤10×109/L

CarryoverWBC≤0.5%；RBC≤0.5%；HGB≤0.5%；HCT≤0.5%；PLT≤0.5%

AccuracyTable A-1 Accuracy Specifications

Parameter Acceptable Limits（%）

WBC ≤±2.0%

RBC ≤±1.5%

HGB ≤±1.5%

MCV ≤±0.5%

HCT ≤±1.0%

PLT ≤±4.0%

PrecisionTable A-2 Precision Specifications

Parameter Acceptable Limits（CV/%） Precision Range

WBC ≤2.0% 4.0×109/L ~ 15.0×109/L

RBC ≤1.5% 3.00×1012/L ~6.00×1012/L

HGB ≤1.5% 100 g/L ~180g/L

HCT/

MCV

≤1.0%

≤0.5%

35%~50%

76fL ~110fL

PLT ≤4.0% 100×109/L ~500×109/L

Appendix A

121

LinearityTable A-3 Linearity Specifications

Parameter Linearity Range Acceptable Limits

WBC0×109/L~10.0×109/L ≤±0.3×109/L

10.1×109/L ~99.9×109/L ≤±5%

RBC0×1012/L ~1.00×1012/L ≤±0.05×1012/ L

1.01×1012/L ~9.99×1012/L ≤±5%

HGB0 g/L ~70 g/L ≤±2g/L

71 g/L ~300 g/L ≤±2%

PLT0×109/L ~100×109/L ≤±10×109/L

101×109/L ~999×109/L ≤±10%

122

Appendix B: Instrument Icons and Symbols

Caution

Caution, risk of electric shock

Biohazard

Equipotentiality

Protective Grounding

Protect from heat and radioactive sources

Consult Instruction for Use

For In Vitro Diagnostic Use

Serial Number

Manufacturer

123

Appendix C: Communication

The system transfers sample data and analyzer information to outer computerthrough RS-232 COM. Communication can be done automatically afteranalysis or manually when the analyzer is in idle mode. This appendix explainsthe settings of communication parameters and data communication formatterfor easy operation.Before communication, please ensure the analyzer has connected with outercomputer through appropriate COM.Communication can be done in hexadecimal format or ASCII format.

1. Hexadecimal Format Communication

1.1 Data Link MAC Sublayer Parameters Convention

Baud Rate: 115200 Parity Digit: NoneData Bit: 8 bits Stop Bit: 1 bit

1.2 Data Link Layer Frame Format

1.2.1 Frame Format

STX LENGTH Message ETX LRC

1.2.2 Meaning of Fields or Control Fields

Name Meaning Value

STX Start of Text 0x02

ETX End of Text 0x03

Message Sending Message Determine by Message content.

LENGTH Length (2 bytes) Determine by Message length

LRC ChecksumDetermine by the content among

STX and ETX, exclude STX.

app:ds:%20%20hexadecimal%20format

app:ds:parity

app:ds:digit

Appendix C

124

1.2.3 Convention

Comply with Big-Enddian format, high byte is prior when transferring.

1.3 Message Field Structure

1.3.1 Message Structure

TYPE DATA

Field Definition:

Field Length

1 TYPE 1

2 DATA xx

TYPE Value:

Type Value

TRANS_CONDITION 0x42

1.3.2 DATA Field Definition

DATAType（1Byte） DATAContent（depends on specific DATA type）

TYPE Value of DATA Field:

DATA Type Value Definition Receive Transmit

CON_TRANS 0x01 Request online status Yes

TRANS_CON 0x02 Transmit online status Yes

DATA Field Content:

If TYPE value of DATA field is TRANS_CON and the opposite party canreceive 0x01 message which sent by us, it means online is normal.

Appendix C

125

2. ASCII Format Communication

2.1 Message Transfer Format

Message transfer formats are <SB> ddddd <EB><CR>.<SB> means the start of massage and its corresponding ASCII sign is <VT>,namely 0x0B;<EB> means the end of message and its corresponding ASCII sigh is <FS>,namely 0x1C;<CR> means the confirmation of termination and the field mark of differentmessage, namely 0x0D;ddddd is the actual transfer content. It includes several fields, each field willend with <CR>, namely 0x0D.

2.2 Massage Grammar

| Field mark^ Component mark& Child component mark~ Repeat mark\ Escape character

2.3 Data Type

CX extended composite id which checks digitCE code elementCM compositeCQ composite quantity with unitsDR datetime rangeDT dataDLN driver’s license numberEI entity identifierHD hierarchic designatorFN family nameFT formatter text

Appendix C

126

IS coded value for user-defined tablesID coded values for HL7 tablesJCC job codeNM numericPT processing typePL person locationST stringSI sequence IDTS time stampTQ timing quantityTX text dataXAD extended addressXCN extended composite ID number and nameXON extended composite name and ID number for organizationsXPN extended person nameXTN extended telecommunications numberVIDversion identifier

2.4 Message Type

The structure of message is as follows：MSH //Message Header{

[PID] //Patient Data{

OBR // Medical Advice[OBX] //Inspection Result

}}

Appendix C

127

Definition of MSH (Message Header):

Number Field Type Length Remark

1 Field mark ST 1

2 Encoding chars ST 4

3 Sending Application EI 180

4 Sending Facility EI 180

5 Receiving Application EI 180

6 Receiving Facility EI 180

7 DateTime Message TS 26

8 Security ST 40

9 MessageType CM 7

10 Message Control ID ST 20

11 Processing ID PT 3

12 VersinID VID 60

13 Keep

14 Keep

15 Keep

16 Keep

17 Keep

18 Encoder ST Encoding (with UNICODE)

Example:MSH|^~\&|manufacturer|UT-3020|LIS|PC|20100930100436||ORU^R01|m

anufacturer-BLD|P|2.3.1||||||UNICODE

Appendix C

128

Definition of PID(Patient Data) Field:Number Field Type Length Remark

1 Set ID PID SI 4Confirm different fields,

generally set 1

2 Patient ID EI 20

3 Patient Identifier List CX 20

4 Alternate Patient ID CX 20

5 PatientName XPN 48

6 Mother Maiden Name XPN 48 Set null

7 Date/Time of Birth TS 26

8 Sex IS 1 M or F

9 Patient Alias XPN 48 Keep

10 Race CE 80 Keep

11 Patient Address XAD 106 Keep

12 County Code IS 4 Keep

13 Phone Number XTN 40 Keep

13 Phone Number Bus XTN 40 Keep

14 Primary Language CE 60 Keep

15 Marital Status CE 80 Keep

16 Religion CE 80 Keep

…Basically, the Latter

parts do not need to fill

Example: PID|1|1010051|A1123145|15|Jame||19811011|M

Appendix C

129

OBR Field:Number Field Type Length Remark

1 Set ID OBR SI 4Confirm different fields,

generally set 1 or null

2 Placer Order Number EI 22

3 Assigned Patient Location EI 22

4 Universal Service ID CE 200

5 Priority ID 2 Set null

6 Requested DateTime TS 26

7 ObservationDatetime TS 26

8 Observation DateTime end TS 26 Set null

9 Collection Volume CQ 20 Set null

10 Collector Identifier XCN 60 Set null

11 SPE ActionCode ID 1 Set null

12 Danger Code CE 60

13 Relevant Clinical Info ST 300Clinical information,

diagnosis or remark etc.

14 SPE Received DateTime TS 26

15 SPE Source CM 300 Blood, urine or others

16 Ordering Provider XCN 120

17OrderCallback Phone

NumberXTN 40

Set null

18 Placer Field1 ST 60 Inspection applicant

19 Placer Field2 ST 60 Set null

20 Filler Field1 ST 60 Set null

… Do not need to fill basically Set null

Example:OBR|1|1010051|000001|manufacturer^UT-3020||20101010093020|20101

010093500|||||| Jaundice||BLD|Tom||011

Appendix C

130

OBX Field:Number Field Type Length Remark

1 Set ID OBX SI4

Confirm different fields,

generally use 1 or null

2 Value Type ID3

NM indicates number type,

ST indicates value type

3 Observation

Identifier

CE590

Observation

Identifier or item ID

4 Observation SubID ST 20

5 Observation value ST 65535 Test result

6 Units CE 90

7 References Range ST 90

8 Abnormal Flags ID 5 Value mark: L H N

9 Probability ID 5 Set null

10 Nature of Abnormal

Test

ID2

Set null

11 Observe Status ID1

Observe results and take F

as final result

12 Date Last Observe TS 26 Set null

13 User Defined

Access Checks

ST20

Original result, such as

absorbance

14 DateTime TS 28 Use for biochemical result

15 Producer ID

16 Responsible

Observer

17 Observation

Method

CE60

Use for biochemical

analyzer

A complete ASCII data example:<SB>MSH|^~\&|[CompanyName]|[InstrName]|LIS|PC|[ResultTime]||ORU^R01|[

InstrType]|P|2.3.1||||||UNICODE<CR>PID|[PatType]|[PatID]|[PatBarCode]|[PatBedCode]|[PatName]||[PatBirth]|[

PatSex]<CR>OBR|[SampleType]|[REQID]|[SampleID]|[CompanyName]^[InstrName]||[S

app:ds:absorbance

Appendix C

131

ampleTime]|[StartTime]||||||[Symptom]||[SanpleType]|[SendDOCName]||[SendDP]<CR>

OBX|[ResultType]|[ValueType]|[ItemID]|[ItemName]|[TestResult]|[Unit]|[ConsultValue]|[Flag]|||F||||[DocDP]|[DOCName]|<CR>

OBX|1|NM|[ItemID]^LeftLine||[TestResult]||||||F||||[DocDP]|[DOCName]|<CR>

OBX|1|NM|[ItemID]^RightLine||[TestResult]||||||F||||[DOCDP]|[DOCName]|<CR>

OBX|1|ED|[ ItemID]||[InstrID]^Histogram^32Byte^HEX^[TestResult]||||||F||||[DOCDP]|[DOCName]|<CR>

<EB><CR>

3 Communication Operations

If choose hexadecimal as transmission mode, the system will send data inhexadecimal format. Likewise, choose ASCII, the system will send data inASCII format.If automatic transmission is on, then after finishing each analysis, the systemwill transmit data through COM automatically. If you do not need, pleasechoose off in setting interface. Users can press “Trans.” in main menu screento transmit data.



app:ds:automatic

app:ds:transmission

spincell3 - cromakit.es · note 1) carefullyreadthismanualbeforefirstoperation. 2)...

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