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 idle
for 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; operator
should follow proper biosafety practices. Dispose waste reagents and
samples in accordance with local, national regulations.
CONTENTS
Copyright and Declaration....................................................................................................... I
Guidance..................................................................................................................................III
Chapter 1 System Description............................................................................................... 1
1.1 Overview..................................................................................................................... 1
1.1.1 Function........................................................................................................... 1
1.1.2 Intended Use...................................................................................................1
1.1.3 Front Panel......................................................................................................2
1.1.4 Rear Panel...................................................................................................... 6
1.2 Parameters................................................................................................................. 7
1.3 Structure......................................................................................................................8
1.3.1 Flow System....................................................................................................8
1.3.2 Electrical System............................................................................................8
1.3.3 Display............................................................................................................11
1.4 Accessory..................................................................................................................11
1.5 Sample Volume........................................................................................................ 11
1.6 Reagent Volume for Single Sample..................................................................... 12
1.7 Test Speed................................................................................................................ 12
1.8 Storage...................................................................................................................... 12
1.9 Background Test...................................................................................................... 12
1.10 Carryover................................................................................................................ 12
1.11 Accuracy..................................................................................................................12
1.12 Precision................................................................................................................. 13
1.13 Linearity...................................................................................................................13
1.14 Transport and Storage Specifications................................................................13
1.15 Environment Requirement................................................................................... 14
1.16 Electrical Requirement......................................................................................... 14
1.17 Reagent...................................................................................................................14
1.17.1 Diluent..........................................................................................................14
1.17.2 Lyse.............................................................................................................. 15
1.17.3 Detergent.....................................................................................................15
1.17.4 Probe Detergent.........................................................................................15
1.17.5 Note of Reagent Use.................................................................................15
1.17.6 Reagent Storage.................................................................................... 16
Chapter 2 Principles of Operation....................................................................................... 17
2.1 Principles of Measuring.......................................................................................... 17
2.1.1 Electrical Impedance Method.....................................................................17
2.1.2 HGB Colorimetric Method...........................................................................18
2.2 Reagents Function.................................................................................................. 19
2.3 Calculation of Parameters......................................................................................19
Chapter 3 Installation and Specimen Analysis..................................................................22
I
Contents
3.1 Unpacking and Inspection......................................................................................22
3.2 Installation Requirements.......................................................................................22
3.3 Power Supply Inspection........................................................................................23
3.4 Tubing Installation....................................................................................................23
3.4.1 LYSE Tubing Installation............................................................................. 23
3.4.2 DILUENT Tubing Installation......................................................................24
3.4.3 WASTE Tubing Installation.........................................................................24
3.4.4 DETERGENT Tubing Installation.............................................................. 24
3.5 Printer Installation (optional)..................................................................................25
3.6 Keyboard and Mouse Installation......................................................................... 25
3.7 Power Connection................................................................................................... 25
3.8 Startup....................................................................................................................... 25
3.9 Background Test...................................................................................................... 26
3.10 Quality Control....................................................................................................... 27
3.11 Calibration...............................................................................................................27
3.12 Collection of Blood Sample................................................................................. 27
3.12.1 Venous Blood Collection...........................................................................28
3.12.2 Peripheral Blood Collection......................................................................28
3.13 Mode Switch...........................................................................................................28
3.14 Sample Counting and Analysis........................................................................... 28
3.14.1 Information Input........................................................................................ 29
3.14.2 Counting and Analysis.............................................................................. 30
3.14.3 Special Function.........................................................................................31
3.15 Result Analysis...................................................................................................... 32
3.16 Report Output.........................................................................................................33
3.17 Result Modification................................................................................................33
3.18 Shutdown................................................................................................................35
3.19 Data Query............................................................................................................. 35
3.19.1 Selection, Browse, Modification and Output of Data........................... 37
3.19.2 Data Deletion.............................................................................................. 38
3.19.3 Workload Statistics................................................................................ 39
3.20 Special Function.................................................................................................... 39
3.20.1 Precision Counting.....................................................................................39
3.20.1.1 Select Sample Results.......................................................................... 40
3.20.1.2 Check Precision......................................................................................40
3.20.2 Trend Graph................................................................................................41
Chapter 4 Soft Keyboard...................................................................................................... 45
4.1 Soft Keyboard Introduction.................................................................................... 45
4.2 Function.....................................................................................................................46
4.2.1 Data Edit........................................................................................................ 46
4.2.2 Condition Query............................................................................................47
4.2.3 Parameter Limit Setting.............................................................................. 48
4.2.4 L-J QC Edit....................................................................................................49
4.2.5 X-B QC Edit...................................................................................................50
II
Contents
4.2.6 X QC Edit.......................................................................................................51
4.2.7 Manual Calibration....................................................................................... 52
4.2.8 Automatic Calibration...................................................................................53
4.2.9 System Setting..............................................................................................54
4.2.10 Service......................................................................................................... 55
Chapter 5 System Setting.....................................................................................................57
5.1 System Maintenance.............................................................................................. 57
5.2 Transfer Setting........................................................................................................58
5.3 Print Setting.............................................................................................................. 59
5.4 Parameter Setting....................................................................................................60
5.5 Date/Time Setting.................................................................................................... 61
5.6 System Version........................................................................................................ 62
Chapter 6 Quality Control..................................................................................................... 63
6.1 Quality Control Options.......................................................................................... 63
6.2 QC Operation........................................................................................................... 64
6.2.1 QC Mode Select........................................................................................... 64
6.2.2 L-J QC............................................................................................................65
6.2.3 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..................................................................................... 84
7.2 Manual Calibration.................................................................................................. 85
7.3 Auto Calibration........................................................................................................86
Chapter 8 Parameter Limit....................................................................................................88
8.1 Limit Review............................................................................................................. 88
8.2 Limit Modification.....................................................................................................90
8.3 Print............................................................................................................................90
Chapter 9 Maintenance......................................................................................................... 91
9.1 Daily Maintenance................................................................................................... 91
9.2 Weekly Maintenance...............................................................................................92
9.2.1 Surface Maintenance...................................................................................92
9.3 Monthly Maintenance..............................................................................................93
9.4 System Maintenance.............................................................................................. 93
9.4.1 Cauterize Aperture....................................................................................... 94
9.4.2 Flush Aperture.............................................................................................. 94
9.4.3 Drain Cups.................................................................................................... 94
9.4.4 Rinse Cups....................................................................................................95
9.4.5 Rinse Fluidics................................................................................................95
9.4.6 Prime Lyse.....................................................................................................96
9.4.7 Prime Diluent................................................................................................ 97
III
Contents
9.4.8 Prime Detergent........................................................................................... 97
9.4.9 Prime Fluidics............................................................................................... 98
9.4.10 Prepare Shipping....................................................................................... 98
9.5 Maintenance before Shipping................................................................................99
Chapter 10 Service.............................................................................................................. 101
10.1 System Check......................................................................................................101
10.1.1 System Status Check..............................................................................101
10.1.2 Valve Check.............................................................................................. 102
10.1.3 Motor Check..............................................................................................104
10.2 System Log...........................................................................................................105
10.2.1 System Log Query Mode........................................................................106
Chapter 11 Troubleshooting................................................................................................110
11.1 Troubleshooting Guidance................................................................................. 110
11.2 Obtaining Technical Assistance.........................................................................111
11.3 Troubleshooting....................................................................................................111
11.3.1 Faults Relate to Reagents...................................................................... 112
11.3.2 Faults Relate to Vacuum.........................................................................112
11.3.3 Faults Relate to 5V Voltage.................................................................... 113
11.3.4 Faults Relate to Test Results................................................................. 113
11.3.5 Faults Relate to Hardware...................................................................... 114
11.3.6 Faults Relate to Temperature.................................................................115
Chapter 12 Precautions, Limitations and Hazards......................................................... 116
12.1 Limitations.............................................................................................................116
12.2 Location Limitations............................................................................................ 116
12.3 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.................................. 123
1.2 Data Link Layer Frame Format........................................................................... 123
1.2.1 Frame Format..................................................................................................... 123
1.2.2 Meaning of Fields or Control Fields................................................................ 123
1.2.3 Convention.................................................................................................. 124
1.3 Message Field Structure...................................................................................... 124
2. ASCII Format Communication...............................................................................125
2.1 Message Transfer Format............................................................................125
2.2 Massage Grammar....................................................................................... 125
2.3 Data Type........................................................................................................125
2.4 Message Type................................................................................................126
3 Communication Operations.....................................................................................131
IV
Copyright and Declaration
Copyright © URIT Medical Electronic Co.,Ltd.
Declaration:
All contents in this manual were strictly compiled according to related laws and
regulations in local, as well as the specific condition of Spincell3 Automated
Hematology Analyzer, covering all the updated information before printing.
URIT Medical Electronic Co.,Ltd. is fully responsible for the revision and
explanation of the manual, and reserves the right to renovate the relevant
contents without separate notification. Some of the demonstration pictures are
for reference and subject to real object if any differences.
All the information included is protected by copyright. No part of this document
may be reproduced, stored or transmitted in any form or by any means unless
written authorization by URIT Medical Electronic Co.,Ltd..
All instructions must be followed strictly in operation. In no event should URIT
Medical Electronic Co.,Ltd. be responsible for failures, errors and other
liabilities resulting from user's noncompliance with the procedures and
precautions outlined herein.
Limited Responsibility for Quality Warranty:
The manual for Spincell3 Automated Hematology Analyzer, defines the rights
and obligations between the manufacturer and the customers about the
responsibility for quality warranty and after-sales service, also the related
agreements on commencement and termination.
URIT warrants the Spincell3 sold by the URIT and its authorized agents to be
free from defects in workmanship and materials during normal use by the
original purchaser. This warranty shall continue for a period of one year since
the date of installation. The instrument service life is 10 years.
I
Copyright and Declaration
URIT assumes no liability in the following situations even during the period
warranty:
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 by
URIT.
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 Department
of URIT. Professional technician and sale representative will be sent to offer
you timely service when necessary.
URIT Medical Electronic Co.,Ltd.
No.4 East Alley, Jiuhua Road, Guilin, Guangxi 541001, PR China
Tel: +86（773）2288586
Fax: +86（773）2288560
Web: www.urit.com
Email: service@uritest.com
Wellkang Ltd t/a Wellkang Tech Consulting
Suite B 29 Harley Street, LONDON W1G 9QR, UK
Version : 07/2015
II
Guidance
General information for the operation of the analyzer is contained in this
manual, which covers the best guidance for a new operator to master the
characteristics of the analyzer and operation methods, as well as for daily
inquiry. 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 proper
function of the analyzer.
NOTE: Denotes special operator/service information or standard practices.
Do
read
through
this
manual
before
operation,
displacement to the analyzer.
URIT Medical Electronic Co.,Ltd. is abbreviated as URIT
III
maintenance,
Chapter 1 System Description
1.1 Overview
Spincell3 is a multi-parameters, automated hematology analyzer designed for
in vitro diagnostic use. It gives accurate test data of human blood cells as the
necessary reference of clinical diagnosis.
1.1.1 Function
Spincell3 adopts Coulter electrical impedance and colorimetry methods to
obtain test data of WBC, RBC, PLT, HGB and other parameters. Meanwhile
analyzer 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 the
visible components in human beings blood.
1
System Description
1.1.3 Front Panel
6
5
1
7
6
3
4
2
Figure 1-1 Front Panel
1. Status Indicator
Run Indicator: Indicates that the analyzer is running a sample.
Standby Indicator: Indicates that the analyzer is ready to run a sample.
2. Aspiration Probe
Aspirate samples.
3. RUN Key
Press the RUN key to startup the aspiration probe and then analyze specimen
only in the screens of main menu or Quality Control. At other screens, the RUN
key is invalid.
4. Recorder
Print the test result.
5. Work Mode Indicator
The light indicator means whole blood mode, and dark indicator means
pre-diluent mode.
6. Touch Screen
10.4 inch LCD . The screen is divided into 5 areas as shown in Figure 1-2.
2
System Description
Prompt Information
Mode
System Time
Test Result
Menu
Figure 1-2 Screen

Prompt Information
Display the prompt information.

Mode
Display the work mode: whole blood mode or pre-diluent mode.

System Time
Display the system date and time.

Test Result
Display the test result.

Menu
Display functional menus which fall into two categories.
First category menu is displayed across the bottom of the main menu screen
as shown in Figure 1-3.
3
System Description
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,
4
System Description
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 parameters
Sev.:
Direct to service window to process self-check and maintenance.
Help: Direct to system help window.
7. Shortcut Key
Figure 1-5 Shortcut Key
Print: 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.
5
System Description
1.1.4 Rear Panel
4
3
1
2
5
13
6
9
11
12
7
10
Figure 1-6 Rear Panel
1. COM1 and COM2
Connect to the standard RS-232 network.
2. PRINTER
Connect to the printers.
3. USB Port
Connect to USB equipment.
4. PS2 port
Connect to the keyboard and mouse.
5. Grounding Terminal
It’s used to ground the analyzer.
6. Fan
It is for the heat dissipation of power supply.
7. Power Receptacle
Connect to the main power cord to the analyzer.
8. Power Switch
Turn the power supply on or off.
9. SENSOR
Connect to the waste sensor.
6
8
System Description
10. DETERGENT
Detergent port connects to the detergent inlet tube.
11. WASTE
Waste port connects to the waste outlet tube.
12. LYSE
Lyse port connects to the lyse inlet tube.
13. DILUENT
Diluent port connects to the diluent inlet tube.
1.2 Parameters
Analyzer can automatically analyze the sample data, differentiates WBCs into
3 differentials and displays 21 parameters and 3 histograms of WBC, RBC and
PLT. Refer to Table 1-1 for details of 21 parameters.
Table 1-1
Abbreviation
21 Parameters
Full Name
Unit
109cells/L
WBC
White Blood Cell Count
LYM%
Lymphocyte Percent
%
MID%
Monocyte Percent
%
Granulocyte Percent
%
GRAN%
LYM#
Lymphocyte Count
109cells/L
MID#
Monocyte Count
109cells/L
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
Mean Corpuscular Hemoglobin Concentration
g/L
GRAN#
MCHC
RDW_CV
RDW_SD
Red Blood Cell Distribution Width Repeat
Precision
Red Blood Cell Distribution Width STDEV
%
fL
109cells/L
PLT
Platelet Count
MPV
Mean Platelet Volume
fL
PDW
Platelet Distribution Width
fL
7
System Description
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). A
host mainly includes FPGA board, WBC metering assembly, RBC/PLT
metering assembly, flow system and a touch screen etc.. Accesories include
power cord and grounding cord.
1.3.1 Flow System
The flow system is composed of solenoid valves, a vacuum pump, a force
pump, a vacuum chamber and plastic tubes.
Solenoid Valve ---These contact two-way or three-way solenoid valves control
the flow of reagent.
Vacuum Pump --- Pump the waste generated in the processing out to the
analyzer, and produce negative pressure.
Force Pump --- Provide positive pressure for reverse clean and lyse mixture.
Vacuum Chamber --- Generate negative pressure and play the role of
temporary 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 control
center of the analyzer. It is used to receive the information from mouse and
keyboard to control the operation of the instrument, to output the information
and 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
8
System Description
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 electrical
switch movements.
1.3.2.3 LMS Board
LMS board is a volume measurement board, measuring a volume of blood
samples to control the test time.
A certain amount of diluted samples are counted after flowing through the ruby
aperture. The liquid is measured by a system composed of a detector and
measuring tube. When the liquid flows through the start detector, there will be
an electrical signal that count is initiated. When the liquid flows through the
stop 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 abnormal
movements in the flow system, the instrument will alarm. Troubleshooting
please refer to the relevant content.
Figure1-7
9
System Description
1.3.2.4 Front-end Signal Panel
It is used to collect various signals, such as count electrical pulse, light
intensity, pressure, temperature, etc., please transfer them to the FPGA board
after 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 pump
to 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 are
submerged in the conductive liquid, creating an electrical pathway through
the micro-aperture.
 Micro-aperture Sensor --- Micro-aperture sensor is mounted on the front
end of WBC cup. Particles pass through the aperture whose diameter is
100μm when processing a sample.
 Flow System --- The flow system uses negative pressure to aspirate
diluent, detergent and sample from each container into metering tube, and
discharge waste at the end of the processing. The step motor controlled
by mainboard runs to add specific volume lyse into WBC cup, then mix it
by the air created by force pump.
10
System Description
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. Both
electrodes are submerged in the conductive liquid, creating an electrical
pathway through the micro-aperture.
 Micro-aperture Sensor --- Micro-aperture sensor is mounted on the front
end of RBC/PLT cup. Particles pass through the aperture whose diameter
is 68 μm when processing a sample.
 Flow System --- The flow system uses negative pressure to aspirate
diluent, detergent and sample from each container into metering tube, and
discharge waste at the end of the processing.
1.3.3 Display
Spincell3 uses a 10.4-inch LCD which can display 21 parameters and 3
histograms.
1.4 Accessory
The accessories of the analyzer include power cord, grounding cord, external
printer (optional), etc.. And the printer should be supplied or authorized by
manufacturer.
1.5 Sample Volume
Whole Blood Mode for Venous Blood:
Venous Blood
10 μL
Pre-diluent Mode for Peripheral Blood:
Capillary Blood
20 μL
Whole Blood Mode for Peripheral Blood:
Capillary Blood
10 μL
11
System Description
1.6 Reagent Volume for Single Sample
Diluent:
31mL
Detergent:
8mL
Lyse:
0.7mL
NOTE: 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 100,000
samples 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
Acceptable Limits（%）
Parameter
WBC
≤±2.0%
RBC
≤±1.5%
HGB
≤±1.5%
MCV
≤±0.5%
HCT
≤±1.0%
PLT
≤±4.0%
12
System Description
1.12 Precision
The precision of analyzer should be complied with Table 1-3.
Table 1-3 Precision
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
≤1.0%
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
WBC
Linearity Range
Acceptable Limits
0×109/L~10.0×109/L
10.1×109/L ~99.9×109/L
0×1012/L ~1.00×1012/L
RBC
HGB
≤±5%
≤±0.05×1012/ L
1.01×1012/L ~9.99×1012/L
≤±5%
0 g/L ~70 g/L
≤±2g/L
71 g/L ~300 g/L
≤±2%
0×109/L ~100×109/L
PLT
≤±0.3×109/L
101×109/L ~999×109/L
1.14 Transport and Storage Specifications
1) Temperature:
-10℃~55℃
2) Relative Humidity:
≤95%RH
3) Barometric Presssure: 50kPa~106kPa
13
≤±10×109/L
≤±10%
System Description
1.15 Environment Requirement
1) Temperature:
15℃~35℃
2) Relative Humidity:
≤90%RH
3) Barometric Pressure:
60kPa~106kPa
1.16 Electrical Requirement
1) Power Supply:
AC 100V～240V
2) Frequency:
50/60Hz
3) Power:
100VA-180VA
4) Fuse:
250V/3A
1.17 Reagent
Reagent is configured specifically for the Spincell3 in order to provide optimal
system performance. Delivery inspection of reagents has been done strictly
according to product standards. Spincell3 indices are derived in the condition
of using specified reagents. Thus using non- manufacturer reagents may lead
to 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 freeze
during storage. Temperatures below 0℃ may cause reagent layering so that
changes its chemical properties and conductivity.
Reagent inlet tubes have a cap attached which can minimizes evaporation and
contamination 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 requirements
as follows:
1) Dilute WBC, RBC, PLT, HGB.
14
System Description
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 can
meets 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 in
granular shape.
3) Transform the hemoglobin to form hemo-compound which is suitable for
the 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 agglomerated
protein in the WBC, RBC cups and measurement circuit.
1.17.4 Probe Detergent
Probe detergent contains effective oxide to dredge the stubbornly-blocked
apertures on the WBC, RBC cups.
1.17.5 Note of Reagent Use
1) Using supporting reagents
Appropriate reagent is necessary for normal operation, daily maintenance and
accurate results. The reagent used must match with analyzer model. The
reasons 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
15
System Description
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.
16
Chapter 2 Principles of Operation
Principles of operation of Spincell3 automated hematology analyzer will be
discussed 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 Figure
2-1 shows, this method is based on the measurement of changes in electrical
current which are produced by a particle, suspended in a conductive liquid, as
it passes through an aperture of known dimensions. An electrode is
submerged in the liquid on either side of the aperture in order to create an
electrical pathway through it.
As each particle passes through the aperture, a transitory change in the
resistance between the electrodes is produced. This change produces a
measurable electrical pulse. The number of pulses generated is indicative of
the number of particles that traversed the aperture. The amplitude of each
pulse 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 only
pulses of a certain amplitude. Thus, the pulses are sorted into various size
channels according to their amplitude.
17
Principles of Operation
Figure 2-1 Electrical Impedance Method
The size channels are basically divided into three categories by a pre-set
classification program in the analyzer as follows:
WBC
35—450
fL
RBC
30—110
fL
PLT
2—30
fL
According to the volume, WBCs handled by lyse can be subdivided into three
Categories: Lymphocyte (LYM), Monocyte (MID) and Granulocyte (GRAN).
LYM
35—98
fL
MID
99—135
fL
GRAN
136—450
fL
2.1.2 HGB Colorimetric Method
Lyse added into the blood sample will crack the membrane of red blood cells
promptly and transfer into a kind of compound which can absorb the
wavelength of 540 nm. Through the comparison of the absorbance between
the pure diluent and the sample, the concentration of sample hemoglobin is
calculated.
18
Principles of Operation
2.2 Reagents Function
In Spincell3, counting system has a high sensitivity of the cell volume. Cells
which are suspended in conducting liquid should be protected from physical
condense and adhesion. Control the osmotic pressure of conducting liquid
(mainly diluent) and keep the structure of cells so as to minimize the volume
change. Lyse can dissolve the RBC membrane fleetly and keep the structure
of 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，PCT
The 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）
19
Principles of Operation
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
differentiation
coefficient of RBC, with the unit of %。
 RBC Distribution Width Standard Difference (RDW-SD) is derived from
RBC histogram，shows the volume distribution standard difference of
RBC, 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 distribution
histogram, its unit is fL.
20
Principles of Operation
P-LCR
LD
( 12fL )
UD
Figure 2-3 P-LCR

P-LCR indicates the ratio of large platelet (≥12 fL). It is derived from
PLT histogram. See Figure 2-3. LD,UD is the differentiating line of 2~6
fL and 12~30 fL. These two lines are decided by analyzer
automatically. P-LCR is the ratio of particles between 12 fL line and UD
to particles between LD and UD.

P_LCC: Large platelet，it is the particles between 12 fL line and UD.
21
Chapter 3 Installation and Specimen Analysis
Initial installation must be performed by an manufacturer authorized engineer
to ensure optimal performance of analyzer. Installation procedures must be
repeated conform to this chapter if the analyzer is moved from the original
installation site.
NOTE: Install analyzer by an unauthorized or untrained person by
manufacturer could result in damage to analyzer which is exclusive of the
warranty. Never attempt to install and operate the analyzer without an
manufacturer authorized representative.
3.1 Unpacking and Inspection
Carefully remove the analyzer and accessories from shipping carton, keep the
kit 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 disconnect
device shall remain readily operable. Please do not place the instrument in the
location where is difficult to operate the disconnect device.
CAUTION: Away from direct sunlight.
CAUTION: Avoid temperature extreme.
22
Installation and Specimen Analysis
CAUTION: Away from centrifuge, X-ray equipment, display or copier.
CAUTION: No cell phone, wireless phone and equipments with strong
radiation 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 any
connections. See Table 3-1 for details.
Table 3-1 Power Supply Inspection
Optimal Voltage
AC220V
Voltage Range
AC（100—240）V
Frequency
（50/60）Hz
WARNING: A grounded power outlet is required to connect directly with the
grounding terminal on the rear panel. Be sure to guarantee the security of the
work site.
CAUTION: A fluctuated voltage would impair performance and reliability of the
analyzer. Proper action such as the installation of E.C manostat (not provided
by manufacturer) should be taken before operation.
CAUTION: Frequent power failure will seriously decrease the performance
and reliability of the analyzer. Proper action such as the installation of UPS (not
provided 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 avoid
contamination by the manufacturer before shipment. Uncover and set the caps
aside 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 LYSE
connector on the rear panel, place the other end into the lyse container. Twist
the cap until secure. Place the container on the same level as the analyzer.
23
Installation and Specimen Analysis
3.4.2 DILUENT Tubing Installation
Remove diluent tube with blue faucet from reagent kit and attach it to DILUENT
connector on rear panel. Place the other end into diluent container. Twist cap
until 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 to
WASTE connector on the rear panel, connect BNC plug with the socket
marked “SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the
waste container until secure. Place the container on the level at least 50cm
lower than the analyzer.
3.4.4 DETERGENT Tubing Installation
Remove the detergent tube with yellow faucet from reagent kit and attach it to
DETERGENT connector on the rear panel. Place the other end into the
detergent container. Twist the cap until secure. Place the container on the
same level as the analyzer.
CAUTION: keep the tube in loose condition after installation, no distortion or
folding.
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 the
reagents have exceeded expiry date, contacts manufacturer Customer Support
Centre for replacement.
WARNNING: The waste must be handled with biochemical or chemical
methods before disposal, or it will cause contamination to the environment.
Users have obligation to follow the local and national environmental
regulations.
24
Installation and Specimen Analysis
3.5 Printer Installation (optional)
Take out the printer from the shipping carton. Inspect the printer carefully
according 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 of
printer.
4) Be sure that the printer power switch is OFF; plug the end of power cord to
power 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 insert
the plugs of keyboard and mouse into the two connector of the line, then
connect to the rear panel with “PS/2” port. It is recommended to place the
keyboard beneath the display.
3.7 Power Connection
Make sure the power switch is OFF (O) and the grounding terminal on the rear
panel is well grounded firstly, then connect the analyzer to the main power with
the power cable.
3.8 Startup
Turn on the power switch on the rear panel, then the status indicator on the
front panel will be orange. The analyzer will start self-checking after loading,
and automatically aspirate the diluent ， detergent and lyse, then rinse the
tubing.
The main menu screen is displayed after self-checking (See Figure 3-1).
25
Installation and Specimen Analysis
Figure 3-1 Main Menu Screen
3.9 Background Test
Background test should be performed after startup and before blood sample
test, 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 be
switched to
“Pre-diluent” mode, then click “Drain” to discharge the
diluent into the tube.
2) At main menu screen, click “Info”, and then modify ID to 0, click “OK” back
to save it.
3) Click
"Pre-diluent" to switch to
“Whole Blood” mode, put the
tube containing diluent beneath aspiration probe and ensure the probe
touch the bottom of tube.
4) Press RUN key on the front panel, move away the tube after the beep
sounds. Then the analyzer starts to count and measure automatically.
5) Counting time of RBC, WBC will be displayed at the lower right corner of
screen during counting. Analyzer will alarm and display the error at top left
corner if the counting time is too long or too short. Refer to Chapter 11 for
26
Installation and Specimen Analysis
problem correction.
6) The acceptable range of background is listed in Table 3-2.
Table 3-2 Acceptable Range of Background
Parameter
WBC
RBC
HGB
PLT
Acceptable Range
≤0.2x109/L
≤0.02x1012/L
≤1g/L
≤10x109/L
If the background result is out of acceptable range, repeat the above
procedures until reach the acceptable results.
NOTE: ID number of background test is set to be 0 by the software to
make 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 initial
installation. Refer to Chapter 6.
3.11 Calibration
manufacturer calibrates the analyzer in factory before shipment. On the initial
installation, if the background results and quality control are normal,
recalibration is not necessary. If not and there are shifts or trends in some
parameters, recalibrate the analyzer referring to Chapter 7.
3.12 Collection of Blood Sample
CAUTION: Consider all the clinical specimens, controls and calibrators etc
that contain human blood or serum as being potentially infectious, wear lab
coats, gloves and safety glasses and follow required laboratory or clinical
procedures when handling these materials.
CAUTION: Blood collection and disposal should be performed according to
the local and national environmental regulations or laboratory’s requirements.
CAUTION: Be sure the blood collection clean and contamination-free. All
27
Installation and Specimen Analysis
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 between
2-8℃ for longer storage.
3.12.1 Venous Blood Collection
Collecting whole blood sample through vein-puncture and store in a clean
sample tube with EDTA-K2•2H2O, which can keep the configuration of WBC,
RBC and avoid platelets aggregation. Gently shake the tube 5~10 times to
make it well mixed.
3.12.2 Peripheral Blood Collection
Capillary blood is usually collected from finger tip. The volume of sample tube
is set to be 20μl.
CAUTION: Never over-press the finger avoiding collecting tissue liquid into
sample 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 to
switch among
Whole Blood Mode for Venous Blood,
Mode for Peripheral Blood and
Pre-diluent
Whole Blood Mode for Peripheral Blood.
Corresponding sign on screen will indicate current operating mode. Press the
shortcut key “Mode” in front of the analyzer can also switch between whole
blood mode and pre-diluent mode.
3.14 Sample Counting and Analysis
Sample counting and analysis is processed as following procedures.
28
Installation and Specimen Analysis
3.14.1 Information Input

Input information manually
Click “Info” at main menu screen, the Info edit window present (shown in
Figure 3-2), input or select data. Click “OK” to save the input data and return to
the main menu. Click “Cancel” to cancel the input data and return to the main
menu.
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-. O
Rh+, 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
Sex
General
No input
Blank, M, F
General
≥16-year
Blank
Man
≥16-year
M
Woman
≥16-year
F
Child
≥1-year and <16-year
Blank, M, F
Infant
≥1-month and < 1-year
Blank, M, F
Neonate
<1-month
Blank, M, F
29
Installation and Specimen Analysis
ID: The ID number is in range from 00000000-99999999. If no ID input, the ID
of 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 blood
sample ID CAN NOT be 0.
3.14.2 Counting and Analysis
Counting and analysis should be performed within 3~5 minutes after blood
collection.

Pre-diluent Mode for Peripheral Blood
1) 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 Blood
1) 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.
30
Installation and Specimen Analysis

Whole Blood Mode for Peripheral Blood
1) 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 main
menu screen after counting and analysis (see Figure 3-1).
If Auto Rec or Auto Print is ON (set in “system setting” screen), the test results
will be printed out automatically.
If problems like clog or bubbles occur during the counting and analysis
procedures, the analyzer will alarm and give indication at the top left corner of
the 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 results
will be printed out automatically.
If problems like clog or bubbles occur during the counting and analysis
procedures, the analyzer will alarm and give indication at the top left corner of
the 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 of
the 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 on
the right side of the histogram.
R1 indicates there is abnormality in the left side of LYM wave peak, which
probably caused by incomplete hemolysis of RBC, platelet clump, giant
31
Installation and Specimen Analysis
platelet, plasmodium, nucleated RBC, abnormal lymphocyte, proteinic or fat
granule.
R2 indicates there is abnormality in the area between LYM wave peak and MID
wave, which probably caused by pathologic lymphocyte, plasmocyte, atypia
lymphocyte, original cell or an increase in eosinophil and basophilia,
R3 indicates there is abnormality in the area between MID wave and GRAN
wave peak, which probably caused by immature granulocyte, abnormal cell
subpopulation, eosinophilia.
R4 indicates there is abnormality in the right side of GRAN wave peak, which
probably 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 the
right side.
PM indicates there is ill-defined boundary between PLT and RBC, which
probably 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 lower
limit while “H” means result is higher than upper limit.
32
Installation and Specimen Analysis

If counting time lower than system setting time, the system will alarm
“WBC bubble” or “RBC bubble”, at the same time display “B” before test
result.

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” in
System 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 customer
needs. After blood sample analysis completed, if Auto Print is ON, test report
will be printed automatically by recorder or printer; if the Auto Trans is ON, test
results will be transmitted to network automatically.
The recorder, printer and transmit are set up at Settings window. Refer to
Chapter 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 reach
clinical or laboratory requirements on special samples, manual classification is
feasible.
CAUTION: Unnecessary or incorrect manual classification will cause
unreliable test results. It is recommended to microscopic exam before clinical
use.
33
Installation and Specimen Analysis
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 surrounded
by a rectangle of red line, then click “Param” to select WBC, RBC, PLT
diagram 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 from
white line to red line.
3) Click “Left” or “Right” to move the classified line, and the value of classified
line will be indicated at the lower right of the screen.
4) Click “Back” after modification, the dialog box as shown in Figure 3-4 will
display; click “NO” to cancel the modification, while click “YES” to save the
modified results.
Figure 3-4 Save Dialog Box
34
Installation and Specimen Analysis
3.18 Shutdown
Shutdown procedure is performed after daily operation and before turning the
analyzer off. Daily maintenance and tubing-clean avoid protein aggregation
during 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, cleaning
and shutdown procedures, “Thank you, and now turn off power” will
appear 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 and
performance of the analyzer, any problems derived from that will NOT be
guaranteed 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 reviewed
and printed out by recorder or printer.
At main menu screen, click “Rev” to enter query screen as shown in Figure
3-6.
Click “Condi” at query screen, then condition query screen will appear as
shown 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.
35
Installation and Specimen Analysis
Figure 3-6 Query
Figure 3-7 Condition Query
36
Installation and Specimen Analysis
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 detail
inquiry 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 and
histograms of selected data will be displayed.
Pgprv/Pgnex: If the data is too much to display in one page, the system will
display the data in more pages. Click “Pgpre” or “Pgnex” to view more
information.
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 to
counterfoil format.
Back: Click “Back” to go back to main menu screen.
37
Installation and Specimen Analysis
3.19.2 Data Deletion
If the sample quantity reaches a certain amount and takes up a large save
space, operator can delete the data termly if necessary. Data deletion is
divided into “Delete” and “Delete All”.
(1) Delete All
Click “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 Figure
3-10, 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 Single
In the interface as shown in Figure 3-8, select the data and then click “Del”, the
dialog 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.
38
Installation and Specimen Analysis
3.19.3 Workload Statistics
At main menu screen, click “Func”→ “Stast” to enter Workload statistics
window. See Figure 3-12. Operation procedure is as follows:
Figure 3-12 Workload Statistics
1) 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.
39
Installation and Specimen Analysis
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 red
letters 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” if
using 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 one
sample results are selected.
NOTE: If only one sample result is selected, the “Mean” indicates the sample
result itself.
40
Installation and Specimen Analysis
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 red
letters like Figure 3-15.
41
Installation and Specimen Analysis
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
42
Installation and Specimen Analysis
. 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 Figure
3-17.
Right: Click “Right”, then the chart pole will shift one grid to the right. See
Figure 3-18.
43
Installation and Specimen Analysis
Figure 3-17 Left Shift Chart Pole
Figure 3-18 Right Shift Chart Pole
Back: Click “Back” to return to Query screen.
44
Chapter 4 Soft Keyboard
Spincell3 adopts t-touch interactive mode. System provides soft keyboard
input mode to facilitate the data input and other input operations. Soft
keyboard is as Figure 4-1 shown.
Figure 4-1 Keyboard
The default soft keyboard is in English lowercase mode, click "CAP" key to
switch to English uppercase mode, as shown in Figure 4-2.
Figure 4-2 Uppercase Mode
4.1 Soft Keyboard Introduction
1. Layout
There 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.
45
Soft Keyboard
2. English Character Input
First 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 from
gray to blue. Click “EH” to switch to English characters input mode. User can
switch between English uppercase or lowercase by clicking “CAP” and then
click the keyboard to input.
NOTE: If current input mode is Chinese, clicking "CAP" to switch to English
uppercase input mode directly. In English uppercase input mode, Chinese
character can not be input.
3. Delete Character
First 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, condition
query, parameters limit setting, control edit, system calibration, system setting
and 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.
46
Soft Keyboard
Figure 4-3 Data Edit
4.2.2 Condition Query
Click “Condi” at query screen, condition query and soft keyboard will pop up at
the 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” to
cancel and exit query. See Figure 4-4.
47
Soft Keyboard
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.
48
Soft Keyboard
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, 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 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, the
soft keyboard will pop up;
4) When the focus is on L-J QC edit screen, click “OK” to save, click “Back” to
cancel and exit. See Figure 4-6.
49
Soft Keyboard
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, 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 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, the
soft 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.
50
Soft Keyboard
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, 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 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, the
soft keyboard will pop up;
4) When the focus is on X QC edit screen, click “OK” to save, click “Back” to
cancel and exit. See Figure 4-8.
51
Soft Keyboard
Figure 4-8 X QC Edit
4.2.7 Manual Calibration
Enter manual calibration 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 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.
52
Soft Keyboard
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.
53
Soft Keyboard
Figure 4-10 Automatic Calibration
4.2.9 System Setting
Enter system setting screen, click "Keyboard", soft keyboard will pop up. If
click "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.
54
Soft Keyboard
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 soft
keyboard will pop up.
4) When the focus is on service screen, click “OK” to save, click “Back” to
cancel and exit. See Figure 4-12.
55
Soft Keyboard
Figure 4-12 Service
56
Chapter 5 System Setting
Spincell3 has 4 options to satisfy different requirements of laboratory and
clinical diagnostics. Operator can choose different operating modes according
to actual need.
At main menu screen, click “Func”. And then click “Setup”. The Setup menu
will 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 a
background test automatically when startup the analyzer each time.
Auto sleep: The analyzer will enter dormancy status if there is no operation for
a period of time
57
System Setting
Pre-diluent notice: If the Pre-diluent is ON, each time when operator runs a
sample, the system will prompt that whether or not to run the sample under
pre-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 communication
parameters are set before delivery. User should not modify them; otherwise
the data can not be transmitted.
Auto trans: the test results will be transmitted from the communication port
automatically.
Encoded: hexadecimal and ASCII.
NOTE: Transfer setting should be under the guidance of manufacturer
engineer.
Figure 5-2 Transfer Setting
58
System Setting
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
59
System Setting
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
60
System Setting
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, D
indicates Day. The selected date format will be displayed.
The resetting of the data format will affect the display format of data on blood
cell analysis screen.
Figure 5-5 Time Setting
61
System Setting
5.6 System Version
User can check the software version, printer software version, printer template
version, FPGA version, kernel version and library version. If there are
problems, the user can provide this information to manufacturer service
engineers as Figure 5-6.
Figure5-6 System Version
NOTE: Above system settings have been set up before delivery. User does not
need to reset them generally. If needed, all the operations should under the
guidance of manufacturer engineer.
62
Chapter 6 Quality Control
Quality control is needed for maintaining the analyzer precision and eliminating
system errors. Spincell3 offers four quality control options: L-J QC,
X
X
QC,
-R QC and X-B QC. In following conditions, perform quality control with
control 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 as
follows:

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. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
6.1 Quality Control Options
(1) L-J QC
L-J QC (Levey-Jennings graph) is a simple and visual QC method. Operator
can draw QC value directly on graph after getting the Mean, SD and CV which
derived from following formulas:
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Quality Control
n
Mean 
SD 
(X
CV % 
(2)
X
-R QC
In
X
-R QC method,
X
X
i 1
i
n
i
 Mean) 2
n 1
SD
 100
Mean
indicates mean value, R indicates range of value.
X
graph is mainly used to judge that if the mean value falls in required level. R
graph is mainly used to judge that if the range of value falls in required level.
(3)
X
QC
X
QC is the variation of
X
-R QC; they have the same basic principle. The
difference is that the control dot in
X
graph indicates the mean value of two
values other than a single value. On this foundation, analyzer calculates the
Mean, SD and CV.
(4) X-B QC
X-B QC is a moving average method promoted in 1970s. It’s based on the
principle that RBC count is varied due to the concentration of dilution, human
blood pathology and technical factor, but the hemoglobin content in specific
unit is hardly interfered by those preceding factors. According to this
characteristic, X-B QC is done by detecting the value of MCV, MCH, and
MCHC.
6.2 QC Operation
6.2.1 QC Mode Select
In main menu screen, click “Func” and then select ”QC”, dialog box as Figure
6-1 will pop up.
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Quality Control
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 Figure
6-2.
Figure 6-2 L-J QC
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Quality Control
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 3
different groups and each group has 3 (low, normal and high) levels. Input
control 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. Limit
indicates the allowable biased range. but the limit should not be more than
40% 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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Quality Control
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 RUN
key, the analyzer will start to process control sample. L-J QC needs control
material. 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 screen
will be updated correspondingly. Lot No. and expiry date can be input in Edit
screen.
Figure 6-4 L-J QC Run
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Quality Control
6.2.2.3 L-J QC Review
Spincell3 offers 2 ways to review: QC Graph and QC Data.
(1) L-J QC Graph
Click “Back” in QC Run screen or select corresponding QC mode in QC Mode
dialog 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 and
low level to run QC, the control dot will present in low 1 graph. It is also true for
other types of QC.
There are function buttons at the bottom of L-J QC screen. Click “Group” to
change the group. Click “Paramr” to change current displayed parameter, for
instance, change from WBC to RBC. Click “Level” to shift the classification line
in the same group. Click “Left” or “Right” to shift the classification line in same
QC graph. Click “Print” to print the current data.
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Quality Control
QC results are arranged in graphs according to storage time. The latest is on
the 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 subtract
limit.
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 the
corresponding graph, it means the dot is in the control range; if not, the dot is
not in the control range.
(2) L-J QC Data
In L-J QC graph screen (see Figure 6-5), click “Data”, operator can review QC
data with 12 parameters as Figure 6-6 shows.
Figure 6-6 L-J QC Data
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Quality Control
In this screen, click “Group” to change group, click “Left” or “Right” to switch
page. 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
Select
X
X
QC Edit
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 Figure
6-7.
Figure 6-7 X QC Edit
In
X
QC Edit screen, click “Group” to switch group; click “Del” to delete the
current 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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Quality Control
NOTE: The expiry date format should be MM-DD-YYYY.
6.2.3.2
In
X
X
QC Run
QC screen click “Run”, enter QC Run screen as Figure 6-8.
At this screen, system displays two control results and calculates the mean
value automatically. The assay is input in
X
QC Edit screen. Click “Group” to
switch group; click “Back” to exit.
Figure 6-8 X QC Run
In
X
QC Run screen, place the control tube under aspiration probe, press
RUN key, the analyzer will start to process control sample. If the current group
assay is empty, the system will display “No QC reference data, cannot perform
QC running”. At this time, operator should back to the Edit screen to input
assay and limit.
X
QC needs control material. If run a background QC, the system will alarm
QC result is invalid.
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Quality Control
6.2.3.3
X
QC Review
Spincell3 offers 2 ways to review: QC Graph and QC Data.
(1)
X
QC Graph
Click “Back” in QC Run screen or select corresponding QC mode in QC Mode
dialog box, enter the
X
QC screen as Figure 6-9 shows. Operator can review
12 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 and
low level to run QC, the control dot will present in low 1 graph. It is also true for
other types of QC.
There are function buttons at the bottom of
X
QC screen. Click “Group” to
change the group. Click “Param” to change current displayed parameter, for
instance, change from WBC to RBC. Click “Level” to shift the classification line
in the same group. Click “Left” or “Right” to shift the classification line in same
QC graph. Click “Print” to print the current data.
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Quality Control
QC results are arranged in graphs according to storage time. The latest is on
the left side and its serial number is 1.
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 the
corresponding graph, it means the dot is in the control range; if not, it is not in
the control range.
(2)
X
QC Data
In L-J QC graph screen (see Figure 6-9), click “Data”, operator can review QC
data with 12 parameters as Figure 6-10 shows.
In this screen, click “Group” to change group, click “Left” or “Right” to switch
page. Operator could review 31 items data at most. Click “DelAll” to delete all
the 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, the
mean value will be displayed.
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Quality Control
Figure 6- 10 X QC Data
6.2.4 X -R QC
6.2.4.1
On
X
X
-R QC Run
-R QC screen click “Run”, enter QC Run screen as Figure 6-11.
At this screen, system displays two control results and calculates the mean
value and range automatically. Click “Group” to switch group; click “Back” to
exit.
X
-R QC needs control material. If run a background QC, the system will alarm
QC result is invalid
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Quality Control
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 Graph
Click “Back” on QC Run screen or select corresponding QC mode in QC Mode
dialog box, enter the
X
-R QC screen as Figure 6-12 shows. Operator can
review QC results with 12 parameters. The dot on
X
-R QC Graph indicates
mean value or range of 2 QC results. The system cannot display low, normal
and high control graphs simultaneously in one screen, please click “Group” to
switch.
X
-R QC graph is divided into 2 parts:
X
graph and R graph.
X
graph
displays mean value dots while the R graph displays range dots.
There are function buttons at the bottom of
X
-R QC screen. Click “Group” to
change the group. Click “Param” to change current displayed parameter, for
instance, change from WBC to RBC. Click “Level” to shift the classification line
between
in
X
X
and R graphs. Click “Left” or “Right” to shift the classification line
or R graph. Click “Print” to print the current data.
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Quality Control
Figure 6-12 X -R QC Graph
QC results are arranged in graphs according to storage time. The latest is on
the left side and its serial number is 1.
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
－A×R.
6. The 3 values on the left side of parameter graph mean:

upper limit ——
X

middle line ——
X

lower limit ——
X
upper limit＝ X ＋A×R
lower limit＝ X －A×R
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X
lower limit＝
Quality Control
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 the
corresponding graph, it means the dot is in the control range; if not, the dot is
not in the control range.
(2)
In
X
X
-R QC Data
-R QC Graph screen (See Figure 6-12), click “Data”, operator can review
QC data with 12 parameters as Figure 6-13 shows.
On this screen, click “Group” to change group, click “Left” or “Right” to switch
page. Operator could review 31 items at most. Click “DelAll” to delete all the
data.
X
-R QC data screen can only display three control results, and each one
contains mean and range. The first two lists on this screen are total mean and
average range. See Figure 6-13.
The QC data would be updated after running new controls twice.
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Quality Control
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 three
parameters: MCV, MCH, and MCHC.
Select X-B QC mode in the dialog box as Figure 6-1 shows. click “OK” to enter
the X-B QC screen, then click “Edit” to enter X-B QC Edit screen. See Figure
6-14.
At Edit screen, click “Del” to delete current assay and limit; click “OK” to save
them; click “Back” to exit.
NOTE: Assay is a standard value which is the reference of quality control. Limit
indicates the allowable biased range. but the limit should not be more than
40% of assay, or it cannot be saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.
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Quality Control
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 Figure
6-15. “X-BQC Run” is for selecting to run X-B QC or not. “Sample num” is for
selecting 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 QC
Data.
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Quality Control
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 Graph
Click “Back” on QC Run screen or select corresponding QC mode in QC Mode
dialog box to enter the X-B QC screen as Figure 6-16. Operator can review QC
results with 3 parameters. After the count of group samples completed, the
results of MCV, MCH, MCHC will be depicted as dots on the graph. For
example, the “X-BQC Run” is ON and “Sample num” is 20, then after 20
counts, the system will calculate a X-B QC value and display a corresponding
control dot on the graph.
X-B QC screen can display graphs of MCV, MCH and MCHC. And the graphs
will 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 on
the left side and its serial number is 1.
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Quality Control
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 the
corresponding graph, it means the dot is under control range; if not, it is not
under control range. See Figure 6-16.
Figure 6-16 X-B QC Graph
(2) X-B QC Data
In the screen as Figure 6-16, click “Data”, operator can review 3 parameters
QC data as Figure 6-17 shows. Click “Left” or “Right” to switch page, operator
could review 31 items at most. Click “DelAll” to delete all the data. The Assay
and Limit can be input and changed in QC Edit screen.
81
Quality Control
The QC data would be updated after running a new control.
Figure 6-17 X-B QC Data
82
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 following
situations:
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 obtained
from 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 the
same time.
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling these materials.
CAUTION: Only calibrators recommended by manufacturer can be used to
accomplish the calibration.
CAUTION: Follow the recommendations provided by manufacturer to store the
calibrators.
CAUTION: Check if the container is broken or cracked before using the
calibrator.
CAUTION: Make sure the calibrators are brought to room temperature and
well 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 all
parameters are accurately calibrated.
83
Calibration
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 Query
screen, 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/
≤1.0%
35% ~ 50%
MCV
≤0.5%
76fL ~ 110fL
PLT
≤4.0%
100×109/L ~ 500×109/L
5) Running with high control in triplicate, then using diluent instead of high
control to test 3 times continuously. Carryover(%) is calculated from the
following 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%
84
Calibration
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 same
mode.
NOTE: If any malfunction occurs during measurement, the test results are
invalid. 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 calculate
the new calibrated value automatically and the date will be updated
simultaneously. 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.
85
Calibration
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 test
value exceed the limit, this critical value will be selected as the new coefficient
for 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
86
Calibration
At Auto Calibration Mode, input assay then place the calibrator tube under the
aspiration probe, press RUN key, the analyzer starts to count and then
displays the results in Value 1 to Value 4 according to the sequence of 4
counts.
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 calibration
date.
Click “Print” to print the new calibration values.
Counting principle of new calibration value:
n
X
i

Mean of the new calibration value： Mean=

New calibration value=(assay/mean value) ×former calibration value

If the new calibration value<70%, consider it equals to 70%; if the new
i=1
n
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.
87
Chapter 8 Parameter Limit
To monitor abnormal blood sample measurement, it is essential for the
operator to setup normal ranges of the parameter according to laboratorial or
clinical requirement. Prompt or indication will be given if the test values exceed
the range. The limits of 21 parameters are discussed in this chapter, any
results exceeding the range will be marked with H (High) or L (Low). H means
the results are higher than the upper limits, while L means the results are lower
than the lower limits.
CAUTION: The shift in parameter limit may cause changes in abnormal
indication of hematology index. Please confirm the necessity for changing.
8.1 Limit Review
At Limit Setting screen, operator can input proper parameter limits or use
default limits. Default limits are different depending on patient group. Figure
8-1 depicts General group limits. Figure 8-2 depicts User 1 group limits
Figure 8-1 General Group
88
Parameter Limit
Figure 8-2 User 1 Group
Click “Def”, the system prompts the operator to decide whether to recover all
the default limits. Select “Yes” to recover parameters of all groups to default
limits; 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 operator
enter Limit Setting screen again.
89
Parameter Limit
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 input
the 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 form
automatically.
90
Chapter 9 Maintenance
Routine care and regular maintenance are essential to keep optimal
performance, minimize system problems and prolong the life span. Procedures
and instructions of preventive maintenance are discussed in this chapter. More
information is available at manufacturer Customer Support Centre.
Preventive
maintenance
should
be
performed
periodically.
Pertinent
maintenance is also included in this Chapter according to actual requirement.
WARNING: A normative maintenance criterion should be performed strictly to
avoid analyzer failure.
WARNING: Perform individual protection before instrument maintenance, such
as wear glove, respirator and lab coat etc.
9.1 Daily Maintenance
Spincell3 is designed with daily auto-maintenance program. As shown in
Figure 9-1, operator can select the auto-clean time to maintain the system.
Please refer to Table 9-1 for time setting.
91
Maintenance
Figure 9-1 System Maintenance Setting
Table 9-1 Time Setting
9.2
Run time (hour)
Time for auto-clean (hour)
>8
4
4< Run time<8
4
Run time< 4
2
Time for auto-clean should be reduced by each year.
Weekly Maintenance
9.2.1 Surface Maintenance
Clean the smudge on the surface of analyzer, especially the spilled blood on
the aspiration probe and surrounding, to remove the protein buildup or debris
and reduce the possibility of a blockage. Wipe the outside of the probe and
surrounding with gauze soaked by litmusless detergent before cleaning other
parts.
92
Maintenance
CAUTION: Never use corrosive acids, alkali or volatile organic solvent (such
as 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, including
lubricant 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 as
Figure 9-2.
Figure 9-2 System Maintenance
93
Maintenance
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 as
follows:
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 with
Cauterize 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
bar at the bottom of the screen.
3. After completing, system will back to the Maintain screen.
9.4.3 Drain Cups
Perform this operation to drain diluent out of WBC and RBC cups.
94
Maintenance
9.4.4 Rinse Cups
Perform this operation to rinse the aperture to prevent blockage when counting
time 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
bar at the bottom of the screen.
3. After completing, system will back to the Maintain screen.
9.4.5 Rinse Fluidics
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling 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 rinse
WBC and RBC cups as well as related tubings with probe detergent. If the
analyzer keeps on working day by day, perform Prime Fluidics every 3 days; If
not, 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 9-3
will pop up, select “Yes” to aspirate the detergent, select “No” to back to
Maintain screen.
Figure 9-3 Prime Fluidics Dialogue Box
2) Remove the detergent after the probe retracting back. Analyzer starts to
perform the function and display progress bar at the bottom of the screen.
95
Maintenance
3) After several seconds, the dialogue box as Figure 9-4 will pop up, put the
probe 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. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling 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 to
make 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.
96
Maintenance
9.4.7 Prime Diluent
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
contain human blood or serum as potentially infectious. Wear lab coats, gloves
and safety glasses and follow required laboratorial or clinical procedures when
handling 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 to
make 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 contain
human blood or serum as potentially infectious. Wear lab coats, gloves and
safety glasses and follow required laboratorial or clinical procedures when
handling 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 to
make 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.
97
Maintenance
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
the bottom of the screen.
3) After completing, system will back to the Maintain screen.
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 as
follows:
1) Select “Rinse Fluidics” 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.
9.4.10 Prepare Shipping
Perform this function before shipping or leave the analyzer unused for a long
time. 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” to
back to Maintain screen.
Figure 9-5 Drain Dialogue Box
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.
98
Maintenance
9.5 Maintenance before Shipping
If the analyzer is left unused for more than 3 months or being shipped, please
perform 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 in
tube.
4) Store the remaining reagents according to instructions and avoid
supercooling and overheating. Operator should establish and conform to
effective 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.
99
Maintenance
Figure 9-6 Select Prepare Shipping
1) After completed, take out the diluent, lyse and detergent tubes from
distilled water and click “Prepare Shipping” again to drain the reagent in
tubes.
2) At main menu screen, click “Exit”, “Thank you, now turn off power” will
appear to instruct the operator to turn off the power switch on the rear
panel.
3) Pull out outlet tube from the rear panel, clean it with distilled water and
save it with plastic bag after dry by airing.
4) Cover the connectors of DILUENT, LYSE, DETERGENT and WASTE on
the 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 the
analyzer and components in plastic bags into the shipping box.
100
Chapter 10 Service
Routine care and regular maintenance are essential to keep optimal
performance, minimize system problems and prolong the life span.
This chapter introduces the Service function, with which operator may monitor
the system status, valve and motor status etc.. More information is available at
manufacturer Customer Support Centre.
CAUTION: Incorrect maintenance may lead to impairment of analyzer. Please
maintain the analyzer according to this manual.
NOTE: If there is any problem which is not discussed in the manual, please
contact the manufacturer Customer Support Centre.
10.1 System Check
Click “Func” at main menu screen, select “Sev”, input “2006” in the pop-up
dialog box to enter the System Check screen.
10.1.1 System Status Check
The System Status Check screen presents the current status information for
example temperature, constant-current source voltage, 5V voltage, HGB zero
voltage, HGB background voltage, WBC stenopaic voltage, RBC stenopaic
etc.. See Figure 10-1.
101
Service
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 are
in normal condition.
102
Service
Figure 10-2 Valve Check
At Valve Check screen, click valve buttons, the corresponding results will be
displayed in result list. See Figure 10-3.
103
Service
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 normal
condition. At the screen, click motor buttons, the corresponding result will be
displayed in result list. See Figure 10-4.
104
Service
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-up
dialog box to enter the System Log screen as Figure 10-5 shows:
105
Service
Figure 10-5 System Log
10.2.1 System Log Query Mode
Data Query
Choose 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.
106
Service
Figure 10-6 Date Query
Event Query
On System Log screen, cancel Date option in check box in top left corner, then
check 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.
107
Service
Figure 10-7 Event Query
Figure 10-8 Event Query
108
Service
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 next
page.
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.
109
Chapter 11 Troubleshooting
This Chapter gives instructions for identifying, troubleshooting and correcting
faults. If malfunction cannot be solved according to this chapter or more
information is needed, please contact manufacturer Customer Support Centre.
11.1 Troubleshooting Guidance
The Troubleshooting Guidance is designed to assist the operator to identify
and resolve analyzer faults. It also gives instructions on obtaining technical
assistance from manufacturer Customer Support Centre. The first step is to
understand the normal operation and preventive maintenance of analyzer.
Rich experience is essential for troubleshooting. Logical troubleshooting can
be divided into 3 steps:
Step 1 Fault Identification:
Operator should have the ability to identify fault cause and understand proper
operation well. Accurate fault identification is essential for troubleshooting.
Step 2 Fault Isolation:
Fault Isolation means further classifying the problem. Analyzer faults are
generally divided into three categories:
a) Faults relate to hardware
b) Faults relate to software
c) Test faults relate to sample analysis
Hardware and software faults can only be corrected by a manufacturer
authorized engineer. While the test faults relate to sample analysis can be
corrected by operator with assistance from manufacturer engineers.
Step 3 Corrective Action:
Corrective Action means taking appropriate action to correct the fault. If
operator is able to correct faults with or without technical assistance from
manufacturer engineer, time spent can be reduced greatly.
110
Troubleshooting
11.2 Obtaining Technical Assistance
If technical assistance is needed, please contact manufacturer Customer
Support Centre. Refer to Copyright and Declaration for Tel. number and fax
number
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 report
Familiar faults and corrective actions are also given in this Chapter. Operator
can identify the fault cause according to warning information and correct the
fault follow Troubleshooting Guide.
11.3 Troubleshooting
Familiar faults and corrective actions are listed as follows. If faults still cannot
be corrected according to this chapter, or more technical assistance is needed,
please contact with manufacturer Customer Support Centre.
111
Troubleshooting
11.3.1 Faults Relate to Reagents
Fault
Lyse Empty
Probable Cause
Corrective Action
Lyse has been
1. Check that if the lyse has been used up;
used up or lyse
2. Perform “Func” → “Maintain” →”Prime Lyse”;
inlet tube is
3. If
blocked.
fault
still
occurs,
please
contact
with
manufacturer.
1. Check that if the diluent has been used up;
Diluent Empty
Diluent has been
2. Perform “Func” → “Maintain” →”Prime Diluent”;
used up.
3. If
fault
still
occurs,
please
contact
with
manufacturer.
1. Check that if the detergent has been used up;
Detergent
Detergent has
2. Perform “Func” → “Maintain” →”Prime Detergent”;
Empty
been used up;
3. If
fault
still
occurs,
please
contact
with
manufacturer.
Waste container is
Waste Full
full or waste sensor
is 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
Fault
Probable Cause
Pressure of
Low Vacuum
Corrective Action
1. Click “Sev”, input password “2006” to enter
vacuum chamber
System Check screen, ensure the vacuum items
did not reach
are in normal condition.
standard value in
time.
2. If
fault
still
manufacturer.
112
occurs,
please
contact
with
Troubleshooting
11.3.3 Faults Relate to 5V Voltage
Fault
Probable Cause
Corrective Action
1. Click “Sev”, input password “2006” to enter
5V Voltage
Problem
Power supply
System Check screen, ensure the 5V Voltage is
module is
in normal condition.
abnormal.
2. If
fault
still
occurs,
please
contact
with
manufacturer.
11.3.4 Faults Relate to Test Results
Fault
Probable Cause
Corrective Action
1. Check
that
if
the
diluent
is
overdue
or
contaminated；
2. Enter
Diluent is
Maintain
screen
and
perform
“Rinse
Fluidics”；
High
contaminated or
Background
overdue; diluents
Maintain screen with probe detergent. Run a
Value
tube or cups are
background test again to check if the fault had
contaminated.
been cleaned;
3. If fault sill occurs, Perform Prime Fluidics at
4. If
fault
still
occurs,
please
contact
with
manufacturer.
1. Click “Sev”, input password “2006” to enter
System Check screen, check “HGB_BACK” and
HGB
Inaccuracy
HGB background
voltage jump
“HGB_ZERO”;
2. If “HGB_BACK” and “HGB_ZERO” are out of
range, contact with manufacturer. Readjust the
voltage with professional assistance.
113
Troubleshooting
1. Perform “Cauterize Aperture” or “Flush Aperture”
Ruby aperture is
in Maintain screen, and then run a background
WBC Clog
clogged; WBC
test to check the counting time;.
or
counting time is
RBC Clog
abnormal; solenoid
valve problem
2. If fault still occurs, perform Prime Fluidics in
Maintain screen;
3. If
fault
still
occurs,
please
contact
with
manufacturer.
1. Diluent or
detergent has
WBC bubble
or
RBC bubble
been used up;
2. Loose reagent
tubing connection
leads 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
Fault
Probable Cause
1. Motor connecting
wire is loose;
Motor
sounds is
abnormal.
2. Travel switch
problem;
3. Motor problem;
Corrective Action
1. Click “Sev”, input password “2006” to enter
System Check screen, ensure the motor items are
in a normal condition;
2. If fault still occurs, please contact with
manufacturer.
4. Motor drive circuit
problem
Counting
time is too
long or no
counting
time.
1. Ruby aperture is
1. If the fault still occurs after eliminating aperture
clogged;
clog, click “Sev”, input password “2006” to enter
2. Valve is not
System Check screen, ensure all valves are in a
working..
normal condition.
2. If
fault
still
manufacturer.
114
occurs,
please
contact
with
Troubleshooting
11.3.6 Faults Relate to Temperature
Fault
Probable Cause
Corrective Action
1. Click “Sev”, input password “2006” to enter
System Check screen, verify the temperature in
Temperature is
System Status Check.
2. If working temperature is out the acceptable
Temperature
abnormal or
is abnormal
temperature sensor
range:
has problems.
environment to meet the requirement;
3. If
fault
15 ℃ -30 ℃ ,
still
manufacturer.
115
occurs,
improve
please
working
contact
with
Chapter 12 Precautions, Limitations and Hazards
Improper operation will lead to errors; even damage to operator or other
people. Therefore, a criterion should be designed to perfect the service
conditions 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 the
right of free service.
3) Using reagents, controls and calibrators which is not specified by
manufacturer may lead to faults even accident. User cannot get free
service from manufacturer in this condition.
4) Repairs can only be done with the permission of manufacturer. Please
using components specified by manufacturer for replacement. For the
problems derived from illegal operation, manufacturer will not offer free
service.
5) Please follow the recommended maintenance schedules and procedures
outlined in Chapter 9. Fail to comply with the requirement will shorten the
life span and affect the test results even cause accident. manufacturer will
not offer free service in this condition.
12.2 Location Limitations
1) Initial installation should be done by a qualified engineer authorized by
manufacturer.
2) Place the analyzer on a stable and level operating platform. Please pay
attention 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
116
Precautions, Limitations and Hazards
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 the
analyzer is grounded well to prevent electrical interference and ensure
safety.
CAUTION:
Serviceman who is not authorized by manufacturer or unqualified
is not allowed to remove the screws on the shell. manufacturer is not liable for
the serious consequences caused by illegal operation.
12.3 Personal Protection and Infection Control
1) Follow required laboratorial or clinical procedures during daily operation or
maintenance. Wear gloves, lab clothing and safety glasses to avoid direct
contact with the samples.
2) Consider all clinical specimens, controls and calibrators etc. that contain
human blood or serum as potentially infectious. Wear standard laboratorial
clothing, gloves and safety glasses and follow required laboratorial or
clinical procedures when handling these materials. Do not smoke, eat or
drink 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 to
clean, dispose and discharge the waste.
4) Follow directions to store reagent, calibrators and controls. Reagents
should be kept away from temperature extremes. Customer should set up
and execute effective safekeeping measurement to prevent expired use,
deterioration, misapplication or ingestion.
117
Precautions, Limitations and Hazards
CAUTION: Reagent will freeze if being stored below 0℃. Disuse the reagent if
is frozen.
CAUTION: Keep away from direct sunlight. Seal the cap of the container and
minimize the pore size to avoid evaporation and contamination.
118
Appendix A: Instrument Specifications
Dimension and Weight
Environmental Requirements
Dimension:
Temperature: 15℃~35℃
530mm(L)×330mm(W)×460mm(H)
Relative Humidity: ≤90%RH
Weight: 23kg
Barometric Pressure:
60kPa~106kPa
Transport and Storage Specifications
Power Specifications
Temperature: -10℃~55℃
Power Supply: AC 100V～240V
Relative Humidity: ≤95%RH
Frequency: 50/60Hz
Barometric Pressure: 50kPa~106kPa
Power: 100VA-180 VA
Fuse: 250V/3A
Scope of Application
Venous blood, peripheral blood of human being
Appearance Specifications
Display: 10.4-inch LCD
Language: English/Simplified Chinese
Parameter: 21 parameters and 3 histograms
Indicator: Status Indicators/Work Mode Indicators
System Alert: Alert message/Alert beep
Ports: Power Receptacle
Printer Ports
RS-232 Port
PS/2 Port
USB Ports
Recorder Specifications
Recorder Width: 48mm
Paper width: 57.5mm
Paper Roll Diameter: 53mm
Print Speed: 25mm/s
119
Appendix A
Sample Volume
Whole Blood Mode for Venous Blood:
Venous Blood
10 μL
Pre-diluent Mode for Peripheral Blood:
Capillary Blood
20 μL
Whole Blood Mode for Peripheral Blood:
Capillary Blood
10 μL
NOTICE: Sample dosages can be different according to analyzer version.
Reagent Volume for Single Sample
Diluent:
31mL
Detergent:
8mL
Lyse:
0.7mL
NOTICE: Sample dosages can be different according to analyzer version.
Background Results
WBC≤0.2×109/L；RBC≤0.02×1012/L；HGB≤1g/L；PLT≤10×109/L
Carryover
WBC≤0.5%；RBC≤0.5%；HGB≤0.5%；HCT≤0.5%；PLT≤0.5%
Accuracy
Table 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%
Precision
Table 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/
≤1.0%
35%~50%
MCV
≤0.5%
76fL ~110fL
PLT
≤4.0%
100×109/L ~500×109/L
120
Appendix A
Linearity
Table A-3 Linearity Specifications
Parameter
WBC
Linearity Range
0×109/L~10.0×109/L
10.1×109/L ~99.9×109/L
0×1012/L ~1.00×1012/L
RBC
HGB
≤±0.3×109/L
≤±5%
≤±0.05×1012/ L
1.01×1012/L ~9.99×1012/L
≤±5%
0 g/L ~70 g/L
≤±2g/L
71 g/L ~300 g/L
≤±2%
0×109/L ~100×109/L
PLT
Acceptable Limits
101×109/L ~999×109/L
121
≤±10×109/L
≤±10%
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
122
Appendix C: Communication
The system transfers sample data and analyzer information to outer computer
through RS-232 COM. Communication can be done automatically after
analysis or manually when the analyzer is in idle mode. This appendix explains
the settings of communication parameters and data communication formatter
for easy operation.
Before communication, please ensure the analyzer has connected with outer
computer 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: None
Data 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
LENGTH
Length (2 bytes)
LRC
Checksum
Determine by Message content.
Determine by Message length
Determine by the content among
STX and ETX, exclude STX.
123
Appendix C
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
DATA Type（1Byte）
DATA Content（depends on specific DATA type）
TYPE Value of DATA Field:
DATA Type
Value
Definition
Receive
CON_TRANS
0x01
Request online status
Yes
TRANS_CON
0x02
Transmit online status
Transmit
Yes
DATA Field Content:
If TYPE value of DATA field is TRANS_CON and the opposite party can
receive 0x01 message which sent by us, it means online is normal.
124
Appendix C
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 different
message, namely 0x0D;
ddddd is the actual transfer content. It includes several fields, each field will
end 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 digit
CE
code element
CM
composite
CQ
composite quantity with units
DR
datetime range
DT
data
DLN
driver’s license number
EI
entity identifier
HD
hierarchic designator
FN
family name
FT
formatter text
125
Appendix C
IS
coded value for user-defined tables
ID
coded values for HL7 tables
JCC
job code
NM
numeric
PT
processing type
PL
person location
ST
string
SI
sequence ID
TS
time stamp
TQ
timing quantity
TX
text data
XAD
extended address
XCN
extended composite ID number and name
XON
extended composite name and ID number for organizations
XPN
extended person name
XTN
extended telecommunications number
VIDversion identifier
2.4 Message Type
The structure of message is as follows：
MSH
//Message Header
{
[PID]
//Patient Data
{
OBR
// Medical Advice
[OBX]
//Inspection Result
}
}
126
Appendix C
Definition of MSH (Message Header):
Number
Field
Type
Length
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
Remark
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
127
Appendix C
Definition of PID(Patient Data) Field:
Number
Field
Type
Length
Remark
Confirm different fields,
1
Set ID PID
SI
4
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
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
…
generally set 1
Set null
Basically, the Latter
parts do not need to fill
Example: PID|1|1010051|A1123145|15|Jame||19811011|M
128
Appendix C
OBR Field:
Number
Field
Type
Length
Remark
Confirm different fields,
1
Set ID OBR
SI
4
2
Placer Order Number
EI
22
3
Assigned Patient Location
EI
22
4
Universal Service ID
CE
200
5
Priority
ID
2
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
300
14
SPE Received DateTime
TS
26
15
SPE Source
CM
300
16
Ordering Provider
XCN
120
XTN
40
17
OrderCallback Phone
Number
generally set 1 or null
Set null
Clinical information,
diagnosis or remark etc.
Blood, urine or others
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
129
Appendix C
OBX Field:
Number
1
2
3
Field
Type
Set ID OBX
Value Type
Observation
Length
SI
4
ID
3
CE
590
Identifier
Remark
Confirm
different
generally use 1 or null
NM indicates number type,
ST indicates value type
Observation
Identifier or item ID
4
Observation SubID
ST
20
5
Observation value
ST
65535
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
ID
2
Test
11
Observe Status
ID
12
Date Last Observe
TS
13
User Defined
ST
1
26
20
Access Checks
14
DateTime
15
Producer ID
16
Responsible
TS
28
fields,
Test result
Set null
Observe results and take F
as final result
Set null
Original result, such as
absorbance
Use for biochemical result
Observer
17
Observation
CE
60
Method
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
130
Appendix C
ampleTime]|[StartTime]||||||[Symptom]||[SanpleType]|[SendDOCName]||[Send
DP]<CR>
OBX|[ResultType]|[ValueType]|[ItemID]|[ItemName]|[TestResult]|[Unit]|[Co
nsultValue]|[Flag]|||F||||[DocDP]|[DOCName]|<CR>
OBX|1|NM|[ItemID]^LeftLine||[TestResult]||||||F||||[DocDP]|[DOCName]|<C
R>
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 in
hexadecimal format. Likewise, choose ASCII, the system will send data in
ASCII format.
If automatic transmission is on, then after finishing each analysis, the system
will transmit data through COM automatically. If you do not need, please
choose off in setting interface. Users can press “Trans.” in main menu screen
to transmit data.
131