URIT-2900Vet Plus Operation Manual 20161020

封面与封底使用 CDR 文件
NOTE
1) Carefully read this manual before first operation.
2) Inspect electrical requirements of analyzer before power on, and

properly connect grounding wire.
3) Turn off the power of analyzer and disconnect power cord if

analyzer is idle for a long time.
4) Do not run analyzer if it’s in an abnormal or damaged condition.
5) There is potential biohazard of reagents and samples; operator should

follow proper biosafety practices. Dispose of waste reagent and
sample in accordance with local, national regulations.
CONTENTS
CONTENTS ................................................................................................ I
Guidance .................................................................................................. V
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 ................................................................................ 1
1.1.4 Rear Panel ................................................................................. 5
1.2 Parameters.................................................................................... 6
1.3 Structure ....................................................................................... 7
1.3.1 Flow System .............................................................................. 7
1.3.2 Electrical System ....................................................................... 7
1.3.3 Display ....................................................................................... 9
1.4 Accessories ................................................................................. 10
1.5 Sample Volume ........................................................................... 10
1.6 Reagent Volume for Single Sample ............................................ 10
1.7 Test Speed .................................................................................. 10
1.8 Storage ....................................................................................... 10
1.9 Background ................................................................................. 10
1.10 Carryover ................................................................................. 10
1.11 Accuracy .................................................................................. 10
1.12 Precision .................................................................................. 11
1.13 Linearity ................................................................................... 11
1.14 Transport and Storage Specifications ...................................... 11
1.15 Environment Requirement ....................................................... 11
1.16 Electrical Requirement ............................................................. 11
1.17 Reagent ................................................................................... 12
1.17.1 Diluent................................................................................... 12
1.17.2 Lyse ...................................................................................... 12
1.17.3 Detergent .............................................................................. 13
1.17.4 Probe Detergent.................................................................... 13
1.17.5 Note of Reagent Use ............................................................ 13
1.17.6 Reagent Storage ................................................................... 13
Chapter 2 Principles of Operation.......................................................... 14
2.1 The Principles of WBC Count and Differential............................. 14
2.2 Test Principles ............................................................................. 14
2.3 WBC Test Principle and Differential............................................. 15
2.4 RBC Test Principle ...................................................................... 16
2.5 Test Principles of RBC Indexes ................................................... 16
2.6 Platelet Test Principle .................................................................. 17
CONTENTS
2.7 HGB Colorimetric Method ........................................................... 17

2.8 Reagents Function ...................................................................... 18
2.9 Calculation of Parameters ........................................................... 18
Chapter 3 Installation and Specimen Analysis ....................................... 20
3.1 Unpacking and Inspection ........................................................... 20
3.2 Installation Requirements ............................................................ 20
3.3 Power Supply Inspection ............................................................. 21
3.4 Tubing Installation ....................................................................... 21
3.4.1 LYSE Tubing Installation .......................................................... 21
3.4.2 DILUENT Tubing Installation .................................................... 21
3.4.3 WASTE Tubing Installation ...................................................... 21
3.4.4 DETERGENT Tubing Installation ............................................. 22
3.5 Printer Installation (optional)........................................................ 22
3.6 Keyboard and Mouse Installation ................................................ 22
3.7 Power Connection ....................................................................... 23
3.8 Startup ........................................................................................ 23
3.9 Background Test ......................................................................... 24
3.10 Quality Control ......................................................................... 25
3.11 Calibration ................................................................................ 25
3.12 Collection of Blood Sample ...................................................... 25
3.12.1 Whole Blood Collection ......................................................... 25
3.12.2 Capillary Blood Collection (Pre-diluent ) ............................... 25
3.13 Whole Blood Mode and Pre-diluent Blood Mode ..................... 26
3.14 Sample Counting and Analysis ................................................ 26
3.14.1 Information Input ................................................................... 26
3.14.2 Counting and Analysis .......................................................... 27
3.14.3 Special Function ................................................................... 29
3.15 Result Analysis ......................................................................... 30
3.16 Report Output .......................................................................... 30
3.17 Result Modification ................................................................... 31
3.18 Shutoff...................................................................................... 32
3.19 Data Query............................................................................... 33
3.19.1 Selection, Browse, Modification and Output of Data ............. 33
3.19.2 Data Deletion ........................................................................ 34
3.19.3 Workload Statistics ............................................................... 35
3.20 Special Function ...................................................................... 35
3.20.1 Precision Counting ................................................................ 35
3.20.2 Trend Graph .......................................................................... 37
Chapter 4 System Setting ...................................................................... 40
4.1 System Maintenance ................................................................... 40
4.2 Transfer Setting ........................................................................... 41
4.3 Print Setting................................................................................. 42
4.4 Reference Value Setting.............................................................. 43
CONTENTS
4.5 Time Setting ................................................................................ 44

4.6 System Version ........................................................................... 44
Chapter 5 Quality Control ...................................................................... 46
5.1 Quality Control Options ............................................................... 46
5.2 QC Operation .............................................................................. 47
5.2.1 QC Mode Select ....................................................................... 47
5.2.2 L-J QC...................................................................................... 48
5.2.3 X QC ........................................................................................ 52
5.2.4 X-R QC .................................................................................... 56
5.2.5 X-B QC..................................................................................... 59
Chapter 6 Calibration............................................................................. 64
6.1 Preparation for calibration ........................................................... 65
6.2 Calibration Manually.................................................................... 66
6.3 Calibration Automatically ............................................................. 68
Chapter 7 Parameter Limit .................................................................... 70
7.1 Limit Review ................................................................................ 70
7.2 Limit Modification ........................................................................ 71
7.3 Print ............................................................................................. 71
Chapter 8 Maintenance ......................................................................... 72
8.1 Daily Maintenance....................................................................... 72
8.2 Weekly Maintenance ................................................................... 73
8.2.1 Surface Maintenance ............................................................... 73
8.3 Monthly Maintenance .................................................................. 73
8.4 System Maintenance ................................................................... 75
8.4.1 Cauterize Aperture ................................................................... 76
8.4.2 Flush Aperture.......................................................................... 76
8.4.3 Drain Cups ............................................................................... 76
8.4.4 Rinse Cups .............................................................................. 76
8.4.5 Rinse Fluidics........................................................................... 77
8.4.6 Prime Lyse ............................................................................... 77
8.4.7 Prime Diluent ........................................................................... 78
8.4.8 Prime Detergent ....................................................................... 78
8.4.9 Prime Fluidics .......................................................................... 79
8.4.10 Prepare Shipping .................................................................. 79
8.5 Maintenance before Shipping...................................................... 79
Chapter 9 Service .................................................................................. 82
9.1 System Check ............................................................................. 82
9.1.1 System Status Check ............................................................... 82
9.1.2 Valve Check ............................................................................. 83
9.1.3 Motor Check............................................................................. 83
CONTENTS
9.2 System Log ................................................................................. 84

9.2.1 Date Query............................................................................... 85
9.2.2 Event Query ............................................................................. 85
9.3 System Adjust ............................................................................. 86
9.3.1 System Calibration ................................................................... 86
9.3.2 Gain Adjust............................................................................... 88
Chapter 10 Troubleshooting .................................................................. 89
10.1 Troubleshooting Guidance ....................................................... 89
10.2 Obtaining Technical Assistance ................................................ 90
10.3 Troubleshooting ....................................................................... 90
10.3.1 Faults Related to Reagents .................................................. 91
10.3.2 Faults Related to Vacuum ..................................................... 91
10.3.3 Faults Related to 5V Voltage ................................................ 92
10.3.4 Faults Related to Test Value ................................................. 92
10.3.5 Faults Related to Hardware .................................................. 93
10.3.6 Faults Related to Temperature .............................................. 94
Chapter 11 Precautions, Limitations and Hazards ................................. 95
11.1 Limitations ................................................................................ 95
11.2 Location Limitations ................................................................. 95
11.3 Safety and Infection Control ..................................................... 96
Appendix A: Instrument Specifications..................................................... 97
Appendix B: Instrument Icons and Symbols ............................................ 99
Appendix C: Toxic and Hazardous Substances or Elements ................. 100
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 China, as well as the specific condition of URIT-2900Vet Plus
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 URIT-2900Vet Plus Automated Hematology Analyzer, defines
the rights and obligations between the URIT and the customers about the
responsibility for quality warranty and after-sale service, also the related
agreements on commencement and termination.
URIT warrants the URIT-2900Vet Plus 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 life is 10 years.
V
Copyright and Declaration
URIT assumes no liability in the following situations even during the period
warranty:
a) Failure due to abuse the instrument or neglect the maintenance.
b) Use reagents and accessories other than manufactured or
recommended by URIT.
c) Failure due to operation not under the instructions described in the
manual.
d) Replace accessories not specified by URIT, or after maintenance or
repair by a service agent not approved or authorized by URIT.
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.D-07 Information Industry District, High-Tech Zone, Guilin,
Guangxi 541004, P.R.China
Tel: +86（773）2288586
Fax: +86（773）2288560
Web: www.urit.com
Email: service@uritest.com
Supplied By: URIT Medical Electronic Co., Ltd.
Wellkang Ltd t/a Wellkang Tech Consulting

Suite B 29 Harley Street, LONDON W1G 9QR, UK
Version : 12/2011-1-C1
VI
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, maintenance,

displacement to the analyzer.
URIT Medical Electronic Co., Ltd. is abbreviated as URIT.
VII
Chapter 1 System Description
1.1 Overview
The Analyzer is a multi-parameter, automated hematology analyzer designed

for in vitro diagnostic use in clinical laboratories, to analyze the human blood
cells, which provide the necessary reference to clinical diagnosis.
1.1.1 Function
The Analyzer uses Coulter electrical impedance and colorimetry methods to

test the parameters of WBC, RBC, PLT and HGB, does three differentials of
WBC and provides the histogram information.
1.1.2 Intended Use
The Analyzer is appropriate to the qualitative and quantitative analysis of the

visible components in animal blood.
1.1.3 Front Panel
Figure1-1
1
System Description
1. Status Indicators
Run Indicator (orange): Donates that analyzer is running a sample.
Standby Indicator (green): Donates that 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 when the screens of main menu and Quality Control are
displayed. At other screens, the RUN key is invalid.
4. Recorder
Print the test result.
5. Work Mode Indicators
Light indicator indicates analyzer is in Whole Blood Mode, and dark indicator
is for Pre-diluent Mode.
6. Display:
10.4-inch LCD. The screen is divided into 5 areas as showing in Figure 1-2：
Alarm Information Mode System Time
Test Result
Menu
Figure 1-2
 Alarm Information
Display the alarm 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
2
System Description
Display functional menus which fall into two categories.
First category menu is displayed across the bottom of the Main Menu Screen
as Figure 1-3:
Figure 1-3
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 the
pre-dilution of capillary blood.
Trans: Transmit specimen data to the network.
Print: Print the specimen data.
Mute: Mute the alert sound.
Animal: Select the animal type of blood sample.
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.
3
System Description
Second category menus as Figure 1-4:
Figure 1-4
Back: Return to the first category menus.
Maint: Direct to maintain screen to perform operations of flush, prime,
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
Figure1-5
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 the
pre-dilution of capillary blood.
4
System Description
1.1.4 Rear Panel
Figure 1-6
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. PS/2 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.
10. DETERGENT
Detergent port connects to the Detergent inlet tube.
5
System Description
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
The analyzer automatically anaLyses the sample data, differentiates the white
blood cells into three subpopulations 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 21 Parameters
Abbreviation Full Name Normal range Unit
WBC White Blood Cell Count 4.0-10.0 109cells/L
LYM% Lymphocyte Percent 20.0-40.0 %
MID% Monocyte Percent 1.0-15.0 %
GRAN% Granulocyte Percent 50.0-70.0 %
LYM# Lymphocyte Count 0.6-4.1 109cells/L
MID# Monocyte Count 0.1-1.8 109cells/L
GRAN# Granulocyte Count 2.0-7.8 109cells/L
RBC Red Blood Cell Count 3.50-5.50 1012cells/L
HGB Hemoglobin Concentration 110-150 g/L（or g/dL）
Hematocrit (relative volume of
HCT 36.0-48.0 %
erythrocytes)
MCV Mean Corpuscular Volume 80.0-99.0 fL
MCH Mean Corpuscular Hemoglobin 26.0-32.0 pg
Mean Corpuscular Hemoglobin
MCHC 320-360 g/L（or g/dL）
Concentration
Red Blood Cell Distribution Width
RDW_CV 11.5-14.5 %
repeat precision
Red Blood Cell Distribution Width
RDW_SD 39.0-46.0 fL
STDEV
PLT Platelet Count 100-300 109cells/L
MPV Mean Platelet Volume 7.4-10.4 fL
PDW Platelet Distribution Width 10.0-14.0 fL
PCT Plateletcrit 0.10-0.28 %
P_LCR Large Platelet Ratio 10－38 %
P_LCC Large Platelet 10－114 109cells/L
6
System Description
1.3 Structure
The analyzer consists of flow system, electrical system, display etc.
1.3.1 Flow System
The flow system is composed of solenoid valves, vacuum pump, plastic tube,
vacuum chamber, dilutor, sample cup and sampler.
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.
Plastic Tube---Reagent and waste flow in the plastic tube.
Vacuum Chamber---Generate negative pressure and play the role of
temporary waste reservoir. It can also generate positive pressure when
flushing.
Dilutor---provide the required dilution and power sources for count, cleaning
and prime.
Sample Cup---The sensor part of the count; it is the most front-end detection
component of data collection.
Sampler---Control the sample probe to complete sampling, dilution and
cleaning.
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 Driver Board
FPGA driver board is the control and conversion center of the analyzer; It will
convert the information from the ARM board into the driver order of the bottom
circuit, and send all the physical information collected by circuit to the ARM
board. It controls the following components and their movement:
 All the valves open and close, reagent aspiration, rinse and waste
discharge.
 Run rolling pump and vacuum pump to offer power to mix reagent,
7
System Description
eliminate clogs, 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 the 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
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.
8
System Description
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/RBC/PLT Metering Assembly
WBC Metering Assembly is composed of signal collection board, electrodes,

micro-aperture sensor and flow system.
 Signals Collection Board --- It provides electrodes constant current,
amplifies and deals with the collected pulse signal for mainboard.
 Electrode --- There are two electrodes in sample cup, one inner electrode
located in front chamber, and one outer electrode located in back chamber.
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
and back chamber. The particles in sample pass through this aperture
which diameter is 68μm 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. There is a Lyse adding
and mixing unit in front of the sample cup. The control board controls the
step motor. When testing the WBC, the Lyse will be added into the sample
cup, and then the vacuum pump will generate compressed gas to mix the
samples.
1.3.3 Display
Analyzer uses a 10.4-inch LCD which displays 21 parameters and 3

histograms.
9
System Description
1.4 Accessories
The accessories of the analyzer include power cord, grounding cord, printer
(optional) etc., and printer should be supplied or authorized by manufacturer.
1.5 Sample Volume
Whole Blood Mode: Whole Blood 10 μL

Pre-diluent Mode: Capillary Blood 20 μL
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
Analyzer is able to process 30 samples per hour.
1.8 Storage
Analyzer contains a memorizer which can store more than 100,000 samples
data.
1.9 Background
WBC≤0.2×109/L；RBC≤0.02×1012/L；HGB≤1g/L；PLT≤10×109/L.
1.10 Carryover
WBC≤0.5%；RBC≤0.5%；HGB≤0.5%；HCT≤0.5%；PLT≤0.5%.
1.11 Accuracy
The accuracy of analyzer should be complied with Table 1-2.

Table 1-2 Accuracy
Parameter Acceptable Limits（%）
WBC ≤±2.0%
RBC ≤±1.5%
HGB ≤±1.5%
MCV ≤±0.5%
HCT ≤±1.0%
PLT ≤±4.0%
10
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 Linearity Range Acceptable Limits
0×109/L~10.0×109/L ≤±0.3×109/L
WBC
10.1×109/L ~99.9×109/L ≤±5%
0×1012/L ~1.00×1012/L ≤±0.05×1012/ L
RBC
1.01×1012/L ~9.99×1012/L ≤±5%
0 g/L ~70 g/L ≤±2g/L
HGB 71 g/L ~300 g/L ≤±2%
0×109/L ~100×109/L ≤±10×109/L
PLT 101×109/L ~999×109/L ≤±10%
1.14 Transport and Storage Specifications
1) Temperature: -10℃~55℃
2) Relative Humidity: ≤95%RH
3) Barometric: 50kPa~106kPa
1.15 Environment Requirement
1) Temperature: 15℃~35℃
2) Relative Humidity: ≤90%RH
3) Barometric: 60kPa~106kPa
1.16 Electrical Requirement
Power Supply: AC 100V～240V

Frequency: 50/60Hz
Power: 130VA-180VA
Fuse: 250V/3A
11
System Description
1.17 Reagent
Reagent is formulated specifically for Analyzer flow systems in order to provide

optimal system performance. Use of reagents other than those specified in this
manual is not recommended as analyzer performance can be affected. Each
Analyzer is checked at factory using specified reagents and all performance
claims were generated with these reagents. Thus non-manufacturer reagents
will lead to defects in analyzer performance or serious mistakes, even
accidents.
Reagents must be stored at room temperature to ensure optimal performance.

All reagents should be protected from direct sunlight, extreme heat, and
freezing during storage. Temperatures below 0℃ may cause reagent layering
that changes the tonicity and conductivity of the reagents.
The reagent inlet tubes have a cap attached that 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 Diluent to meet the requirements as

follows:
1) Dilute WBC, RBC, PLT, HGB.
2) Keep the shape of cells during test process.
3) Offer appropriate background value.
4) Clean sample cups’ micro-apertures and tubes.
5) Ensure analyzer could obtain pulses which are corresponding to cells’ size
with proper conductivity.
1.17.2 Lyse
Lyse is a new reagent without NaN3 complex and cyanide and meets the
requirements as follows:
1) Dissolve RBC instantly with minimum ground substance complex.
2) Transform membrane of WBC to diffuse cytoplasm.WBC shrinks making
membrane-bound nucleus. As a result, WBC is present in granular shape.
3) Transform the hemoglobin to the hemo-compound which is suiTable for the
measurement in the condition of 540nm wavelength.
4) Avoid scyanide’s serious pollution to human body and environment.
12
System Description
1.17.3 Detergent
1) Detergent contains the active enzyme to clean the agglomerated protein in

sample cups and measurement circuit.
2) Promote emulsification of fat and break down protein to water-soluble
amino acid to keep the cleanness of tubes and counting chambers.
3) Help to quickly discharge the bubbles in flow system with excellent
humidification to ensure normal operation of analyzer.
4) Never color and corrode tubes.
1.17.4 Probe Detergent
Probe Detergent contains effective oxide to dredge the stubbornly-blocked

apertures on sample 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:
a) Impedance method is to get the data according to cell pulse size and
setting threshold value.
b) Cell pulse size is related to type, concentration and adding amount of
Lyse as well as hemolysis time.
c) Cell pulse size is related to osmotic pressure of Diluents, ion strength
and conductivity.
d) 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.
5) Reagent is valid for 1 year. Please refer to package or label for Model,
batch number and date of manufacture.
13
Chapter 2 Principles of Operation
Principles of operation of Analyzer automated hematology analyzer will be

discussed in this chapter. The two independent measurement methods used in
the analyzer 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 The Principles of WBC Count and Differential
The principles of electrical impedance method WBC count are based on the
non-conductive nature of the blood cells. When the blood cell particles in the
Diluent through the ruby aperture that the resistance will change, so that the
WBC count and volume can be got.
2.2 Test Principles
Analyzer blood cell analyzer uses a single channel to count, that WBC and
RBC count are completed respectively in the same sample cup. Quantitative
samples are diluted by quantitative dilution, Keep part of the blood diluted in
the sample probe. After the blood diluted in the sample cup is damaged by
Lyse, analyzer will run WBC counting.
Figure 2-1
14
Principles of Operation
The outer and inner electrode of the constant current source are located in the
front and back chamber respectively. There is a ruby aperture with 80 μm
diameter between these two chambers. The back chamber is full of some
electric liquid, and the front chamber is full of some dilution.
When a particle passes the ruby aperture, there will be a transitory electrical
pulse between the inner and outer electrodes, since the cell conductivity is
lower than that of dilution. 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. A volume
of cells will pass the ruby aperture under the negative pressure to generate a
series of pulse signals. we can obtain a certain volume of total cells number by
pulse amplification, identification, deformation, valve adjustment and A/D
conversion.
2.3 WBC Test Principle and Differential
There is a histogram which can display the average volume of specific cells
population, cells distribution and abnormal cells.
Add a certain amount of dilution and Lyse into the WBC sample cup. This Lyse
can make the RBC dissolved and WBC dehydrate to be "film covers core." So
that the processed WBC volume is between 35 fL and 45 fL. In the
measurement of WBC, analyzer divide distribution range of WBC volume
(35~450 fL) into 256 channels. Each channel is 1.64 fL. Pulse of each WBC is
saved in corresponding channel according to its volume and then being
processed by a computer to compose a smooth curve so as to get a WBC
volume distribution histogram (Figure 2-2). The ordinate indicates the relative
quantity of WBC (rel.no) and the abscissa indicates the volume of WBC (fL).
Figure 2-2
The size channels are basically divided into three categories by a pre-set
classification program in the analyzer as follows:
15
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
2.4 RBC Test Principle
RBC test principle is similar to WBC test principle. In the sample cup which is
the same as that of WBC, with the effect of negative pressure, a certain
amount of cells go through ruby aperture (80μm) and produce corresponding
pulse in size. Analyzer can work out total number and average volume of RBC
according to the size and height of pulse. Meanwhile, it can also get a RBC
volume distribution histogram (Figure2-3) according to single measured RBC
volume and the percentage of cells which have the same volume.
Figure 2-3
2.5 Test Principles of RBC Indexes
HCT can be worked out by dividing the product of MCV and RBC by 10.
According to relative algorithm, the instrument can get MCH, MCHC though
RBC, MCV and HGB. Red Cell Distribution Width (RDW) can be Figured out by
detecting RBC number and the difference of RBC size so as to reflect the
heterogeneity of RBC volume. RDW can reflect the degree of RBC size
difference and has clinical significance of anemia diagnosis.
16
2.6 Platelet Test Principle
Platelet (PLT) and RBC are being tested in the same sample cup. The
instrument will count platelet and RBC respectively according to different
threshold (Figure 2-4). Data of platelet are being saved in 64 channels in 2~30
fL interval.
 Platelet RBC
 Threshold Threshold
 Line Line
Platelet RBC
Figure 2-4
PDW can be worked out by computer though histogram. MPV is the arithmetic
mean volume of platelets which are shown by the curve in histogram. MPV of
normal people has a nonlinear negative correlation with platelet number. PCT
is got from MPV and PLT.
2.7 HGB Colorimetric Method
Analyzer adopts photoelectric colorimetry to measure and calculate HGB. Add

Lyse into the diluted sample, then RBC will dissolve and release hemoglobin.
Then the hemoglobin combines with Lyse to form cyanohemoglobin. Measure
the transmission light intensity of this compound in sample cup through the
monochromatic light of 540nm wavelength and then compare it with the result
in blank state to get the hemoglobin concentration (blank state refers to the
state that only has Diluent in sample cup). Instrument can testing automatically,
then calculate and print out the result (in g/L) .
E 
HGB  K   B  ；
 ES 
K is a constant.
EB is the luminous intensity of light pass through the background.
ES is the luminous intensity of light pass through the samples.
17
2.8 Reagents Function
In Analyzer, counting system has a high sensitivity of the cell volume. Cells
which are suspended in conducting liquid should avoid 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.
2.9 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）
WBC histogram is as Figure 2-5.
Figure 2-5 WBC Histogram
AL: quantity of cells in area of LYM

AM: quantity of cells in area of MID
AG: quantity of cells in area of GRAN
18
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.
P-LCR
LD ( 12fL ) UD
Figure 2-6
 P_LCR indicates the ratio of large platelet (≥12 fL). It is derived from
PLT histogram. See Figure 2-6. 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.
19
Chapter 3 Installation and Specimen Analysis
Initial installation of analyzer must be performed by a manufacturer authorized

engineer or representative to ensure that all system components are
functioning correct and to verify system performance. Installation procedures
must be repeated if the analyzer is moved from the original installation site.
NOTE: Installation of the analyzer by an unauthorized or untrained person by

manufacturer could result in damage to the analyzer which is exclusive of the
warranty. Never attempt to install and operate the analyzer without a
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
Please refer to section 11.2 of chapter 11.

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 difficult to operate the disconnect device.
CAUTION: Away from direct sunlight.

CAUTION: Avoid temperature extreme.
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.
20
Installation and Specimen Analysis
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 Voltage Range Frequency
AC220V AC（100—240）V 50/60Hz
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.
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
21
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.
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 one 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
22
keyboard beneath the display. Please install keyboard and mouse before
starting-up. If not, restart the instrument to make the keyboard and mouse
available.
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 and Lyse reagent, then rinse the tubing.
Main Menu Screen is displayed after self-checking (See Figure 3-1).
Figure 3-1
23
3.9 Background Test
Background test should be performed after startup and before blood sample
test, operate as follows:
Test procedures in Pre-diluent Blood Mode：
1) Put the clean empty tube under the aspiration probe. At Main Menu
Screen, click “Drain” to dispense the Diluent into the tube.
2) At Main Menu Screen, click “Info”, and then modify ID to 0, click “OK”
back to save it.
Remark: 0 is the specialized ID number for background test. In
blood sample test, the ID number cannot be 0.
3) Put the tube containing Diluent beneath aspiration probe which should
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.
Test procedures in Whole Blood Mode：
1) Perform the operations in b), then press RUN key, the analyzer starts
to count and measure automatically.
2) Counting time of RBC, WBC will be displayed at the lower right corner
of screen during counting. The analyzer will alarm and display the error
at top left corner if the counting time is too long or too short. Refer to
Chapter 10 for problem correction.
3) The acceptable range of background is listed in Table 3-2.
Table 3-2 Acceptable Range of Background

Parameter Acceptable Range
WBC ≤0.2x109/L
RBC ≤0.02x1012/L
HGB ≤1g/L
PLT ≤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.
24
3.10 Quality Control
Quality control should be performed before daily test or on the initial

installation. Refer to Chapter 5.
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 6.
3.12 Collection of Blood Sample
CAUTION: Consider all clinical specimens, controls and calibrators etc. as

potentially infectious. Wear lab coats, gloves and safety glasses and follow
required laboratorial 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
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 Whole 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 Capillary Blood Collection (Pre-diluent )
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.
25
3.13 Whole Blood Mode and Pre-diluent Blood Mode
Whole Blood Mode switch to Pre-diluent Mode: In the screen as Figure 3-1
shows, click the animal icon to switch to Pre-diluent Mode. (Animal
icon is red in Whole Blood Mode)
NOTE: Each animal has its corresponding icon which is similar to the animal
appearance.
Operation of switching Pre-diluent Mode to Whole Blood Mode is basically the

same. Click the animal icon to switch to Whole Blood Mode. (Animal
icon is yellow in Pre-diluent Mode)
Press the shortcut key “Mode” in front of the analyzer can also switch mode.
3.14 Sample Counting and Analysis
Sample counting and analysis is processed as following procedures.
3.14.1 Information Input
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

Master Name: Input alphanumeric characters.
26
Pet Name: Input alphanumeric characters.

Pet Sex: Select male or female. If not selected, default as blank.
Age: Input Year, Month and Day.
Tel.: Input owner’s telephone number.
Checker: Input checker’s name or code.
Sample No.: Input alphanumeric characters.
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.
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
Figure 3-3
Counting and analysis should be performed within 3~5 minutes after blood
collection.
1) In the screen as Figure 3-3 shows, click “Animal” on the lower right corner
to inter the screen as Figure 3-4 shows:
27
Figure 3-4
2) Choose the animal type needed and click “OK” for saving. Then click “Back”
to go back to the screen as Figure 3-3 shows. System internal parameter
value will change to meet the requirements of corresponding animal type.
3) There are 2 types of testing mode to choose from.
■ Pre-diluent Mode
1) Present the empty sample tube under the aspiration probe. At Main
Menu Screen, click “Drain”; Diluent will be drained 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) The results will be available after the analysis is performed.
■ Whole Blood Mode

1) Gently shake the tube to well mix the blood sample, then present the
sample tube beneath the probe, make sure the probe touches tube
bottom slightly.
28
2) Press RUN key and remove the sample after hearing beep sound.
3) Results will be available after the analysis is performed.
The 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 Print is ON (set in “system setting” interface), the test results will be
printed out automatically.
If problems like clogs 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.
3.14.3 Special Function
There are two kinds of alarms: parameter alarm and histogram alarm.
3.14.3.1 Parameter Alarm
1. ”H” or “L” present on the right side of the parameter means the result is
out of the range of reference value.
2. “***” 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 LY wave peak, which

probably caused by incomplete hemolysis of RBC, platelet clump, giant
platelet, plasmodium, nucleated RBC, abnormal lymphocyte, proteinic and fat
granule, or electrical noise.
R2 indicates there is abnormality in the area between LY wave peak and MO

wave, which probably caused by pathologic lymphocyte, plasmocyte, atypia
lymphocyte, an increase in original cell or eosinophil, basophilia, .
R3 indicates there is abnormality in the area between MO wave and GR wave

peak, which probably caused by immature granulocyte, abnormal cell
subpopulation, eosinophilia.
R4 indicates there is abnormality in the right side of GR 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
29
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
Analyzer provides plenty and convenient result analysis functions.

 Click “Histo” to modify the test results. Refer to Section 3.17 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.
 If counting time lower than system setting lower limit, 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: The parameter value is *** means invalid data.

NOTE: If there is PLT Histogram Alarm, the PDW probably is ***.
NOTE: WBC differentiation may be incorrect if WBC is lower than 0.5 x109 /L.
Microscope examination is recommended.
3.16 Report Output
Analyzer 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, transmit and test reports are set up at Settings. Refer to
30
Chapter 4 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.
The procedures are as follows:

1) At Main Menu Screen click “Histo”, then the interface as shown in Figure
3-5 will display. The histogram of WBC has been selected, then click
“Param” to select WBC, RBC, PLT diagram parameter that needs
modification.
Figure 3-5
2) Once the diagram parameter needed to modify is selected, click “Class” to

select the desired classification, then the classified line will change from
31
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 3-6 will
display; click “No” to cancel the modification, while click “Yes” to save the
modified results.
Figure 3-6
3.18 Shutoff
Shutoff 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.
Shutoff procedure is as follows:

1) At Main Menu Screen, click “Exit”, shutoff information will appear (see
Figure 3-7).
Figure 3-7
If turn off the instrument, click “Yes”. After finishing the maintenance,
cleaning and shutoff procedures, “Thank you, now turn off power” will
appear to instruct the operator to turn off the power switch on the rear
panel.
2) Tidy the work platform and dispose waste.
3) Click “No” if the operator does not want to shutoff the analyzer.
NOTE: Wrong operations on shutoff 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.
32
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
3-8.
Figure 3-8
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 3-8 shows.
 Condi: Query data 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 the other
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.
33
 Back: Click “Back” to go back to Main Menu Screen.
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 “Del.” and “DelAll”.
1) Delete All
Click “DelAll”, a dialog box as Figure 3-9 will present, input password 9999 to
delete all data.
Figure 3-9 Delete All Password
Figure 3-10
Click “Cancel” to back to Main Menu Screen (See Figure 3-3). Click “OK” to
display a confirm dialog box (See Figure 3-10), select “No” to cancel the
deletion, select “Yes” to delete all data.
2) Delete
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
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,
34
please operate with caution.
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
a) At “From” and “To”, select starting date and ending date in pop-up
calendar, then press “OK”.
b) Select one statistic type on left side of the Workload Statistics screen,
and then display all items in the middle list box.
c) Select statistic item (or multi-select), click “Stast”, then the desired
data will be displayed in list on right.
d) Choose one sender, and click “Print”, then all the items will be print.
e) Click “Back” to return to Main Menu Screen.
3.20 Special Function
3.20.1 Precision Counting
At Query screen, operator may check the sample precision.
35
3.20.1.1 Select Sample Results
After data review from condition query, click one result, the result will be
selected and turn blue as Figure 3-13. Click it again to deselect it.
Figure 3-13 select sample results
3.20.1.2 Check Precision
After selecting one sample result as preceding method, press F9 to enter the
CV data screen like as Figure 3-14.
“Mean” indicates the parameter average value of selected sample. “CV”
indicates the Coefficient of Variance of corresponding parameter.
NOTE: The system can only calculate CV automatically when more than one
sample result are being selected.
NOTE: If only one sample result is being selected, the “Mean” indicates the
sample result itself.
36
Figure 3-14 Check Precision
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, the result will be
selected and turn blue as Figure 3-15. Click it again to deselect it.
37
Figure 3-15 Select Sample Results
Second, review the trend graph.

After selecting one sample result as preceding method, press F8 to enter the
trend graph screen like Figure 3-16.
Figure 3-16 Trend Graph Review

Param.: Click “Param” to review another parameter trend graph;
38
Left: Click “Left”, then the chart pole will shift one grid to the left. See
Figure3-17.
Right: Click “Right”, then the chart pole will shift one grid to the right. See
Figure 3-18.
Figure 3-17 Left Shift
Figure 3-18 Right Shift
Back: Click “Back” to return to Query screen.
39
Chapter 4 System Setting
Analyzer has options to satisfy the 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 4-1:
Figure 4-1
4.1 System Maintenance
Warning: Alarm the errors in analyzer.

Auto-clean: The analyzer will rinse automatically in set time.
Auto-blank.: Select “ON” in Auto-backg. and click “OK”, the analyzer will run
background test automatically when startup the analyzer each time.
Auto-sleep: The analyzer will enter dormancy status if there is no operation in
set-time.
Pre-diluent notice: If the Pre-diluent notice 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.
40
System Setting
Pre-diluent close: If Pre-diluent Mode is left unused for a long time, operator
could choose to close Pre-diluent Mode in System Setting screen under the
Whole Blood Mode. Then system will fix on Whole Blood Mode and cannot
switch to Pre-diluent Mode.
4.2 Transfer Setting
Figure 4-2
In transfer setting as Figure 4-2, 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 cannot be transmitted.
Auto-tran: the test results will be transmitted from the communication port
automatically.
Trans. Mode: hexadecimal and HL7 is available.
NOTE: Transfer setting should be under the guidance of manufacturer

engineer.
41
System Setting
4.3 Print Setting
Figure 4-3
In Print Setting as Figure 4-3, operator can select printer type, print format,
auto print, and input hospital name in “print title” or “record title”.
Printer type: Recorder, USB port PCL printer, parallel port stylus printer.
Print format: Vertical record with histogram and without reference value,
vertical record without histogram and without reference. Operator can only
select the print format which is available in recorder. if choose external printer,
there are 2 print types to choose from: print with histogram and print without
histogram.
Auto print：if select "on", the results will be printed by the printer or recorder; if
select "off", the results will not be printed.
42
System Setting
4.4 Reference Value Setting
Figure 4-4
In Reference Value Setting as Figure 4-4, operator can setup the unit of WBC,
RBC, PLT, HGB and MCHC, as well as the language and order of the
reference value.
User can select Chinese or English in system language. After that user must
restart the instrument to change the system language.
User can select the reference language which is the language on the screen.
User can select the order for the reference value: low to high, high to low and
none.
43
System Setting
4.5 Time Setting
Figure 4-5
In Time Setting as Figure 4-5, there are three 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 change the display format of data on blood
cell analysis interface.
User can change year, month, day and time on this interface.
4.6 System Version
User can check the software version, FPGA version, kernel version and library
version. If there are problems, the user can provide this information to
manufacturer service engineers as Figure 4-6.
44
System Setting
Figure 4-6
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.
45
Chapter 5 Quality Control
In order to maintain the analyzer precision and eliminate system errors, it’s
necessary to perform quality control. Analyzer offers four quality control
options: L-J QC, X-B QC, X-R QC and X QC. In following conditions, perform
quality control using manufacturer recommended control materials.
 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 accuracy of the results, 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 the 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. as

potentially infectious. Wear lab coats, gloves and safety glasses and follow
required laboratorial or clinical procedures when handling these materials.
5.1 Quality Control Options
(1) L-J QC
L-J QC (Levey-Jennings graph) is a simple and visual QC method with which
operator can draw QC value directly on graph after get the Mean, SD and CV.
Mean, SD and CV are derived from following formulas:
n
X i
Mean  i 1
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Quality Control
SD 
( X i  Mean) 2
n 1
SD
CV %   100
Mean
(2) X-R QC
In X-R QC method, X indicates mean value, R indicates range of value. X
graph is mainly used to judge that if the mean value falls in required level. 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 one value. On this foundation, calculate the Mean, SD and
CV.
(4) X-B QC
X-B QC is a moving average method which is first 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, quality control the samples by surveying the
value of MCV, MCH, and MCHC.
5.2 QC Operation
5.2.1 QC Mode Select
Click “QC” in Main Menu Screen, dialog box like Figure 5-1 will present.
Figure 5-1 QC Mode Select
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Quality Control
Analyzer offers four quality control options: L-J QC, X-B QC, X-R QC and X
QC.
5.2.2 L-J QC
Select L-J QC Mode and click “OK” to enter corresponding screen like Figure
5-2.
Figure 5-2 L-J QC
5.2.2.1 QC Edit
In L-J QC screen click “Edit”, enter QC Edit screen as Figure 5-3. There are 3
different groups of control and each group has 3 (low, normal and high) levels.
Input control lot No., expiry date, assay and limit according to the control
instruction.
NOTE: The limit should not be more than 40% of assay, or the limit cannot be
saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.
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Quality Control
Figure 5-3 L-J QC Edit
5.2.2.2 QC Run
In L-J QC screen click “Run”, enter QC Run screen as Figure 5-4.

At 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 can not perform QC
running”. At this time, operator should back to the Edit screen to input assay
and limit.
L-J QC needs control material. If run a background QC, the system will alarm
QC result is invalid.
Each time run a QC, Run Time on upper right corner of the Run screen will be
updated correspondingly. The lot No. and expiry date are input in Edit screen.
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Quality Control
Figure 5-4 L-J QC Run
5.2.2.3 L-J QC Review
There are two ways to review.

(1) QC Graph
Click “Back” in QC Run screen or select corresponding QC Mode in QC Mode
dialog box, enter the L-J QC screen as Figure 5-2 in where operator can
review 12 parameters QC results.
In L-J QC screen, there are low, normal and high graphs. If select group 1 and
level low to run a control sample, the control dot will present in low 1 graph.
The other selection will present in corresponding graph.
There are function buttons at the bottom of L-J QC screen. Click “Group” to
change the group. Click “Param” to change current displayed parameter, for
instance, WBC changes 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.
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
QC graph instruction:
1. Graph abscissa indicates Q display 31 dots.
2. Every parameter graph’s upper transverse line means assay plus limit.
3. Every parameter graph’s lower transverse line means assay subtract
limit.
4. 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 under control range; if it’s out of the
above area, the dot is not under control range.
(2) QC Data
In Figure 5-2, click “Data”, operator can review 12 parameters QC data as
Figure 5-5.
Figure 5-5 L-J QC Data

In this screen, click “Group” to change group, click “Left” or “Right” to view next
page. Operator could review 31 items data at most. Click “DelAll” to delete all
the data.
The assay and limit are input and changed in QC Edit.
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Quality Control
The QC data would be updated after running a new control.
5.2.3 X QC
5.2.3.1 X QC Edit
Select X QC Mode in Figure 5-1 and click “OK” to enter corresponding screen.
Click “Edit”, enter X QC Edit screen as Figure 5-6.
Figure 5-6 XQC 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.
saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.
5.2.3.2 X QC Run
In X QC screen click “Run”, enter QC Run screen as Figure 5-7.

At this screen, system displays two controls result and calculates the mean
value automatically. The assay is input in X QC Edit screen. Click “Group” to
switch group; click “Back” to exit.
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Quality Control
Figure 5-7 XQC Run

In 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, can not 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.
5.2.3.3 X QC Review
There are two ways to review.

(1) 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 5-8 in where operator can review
12 parameters QC results. As a difference to L-J QC Graph, the dot on X QC
Graph indicates mean value of two QC results.
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Quality Control
Figure 5-8 XQC

In X QC screen, there are low, normal and high graphs. If select group 1 and
level low to run a control sample, the control dot will present in low 1 graph.
The other selection will present in corresponding graph.
There are function buttons at the bottom of X QC screen. Click “Group” to
instance, WBC changes 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.
QC graph instruction:
1. Graph abscissa indicates QC run times, ordinate indicates QC result.
2. Every parameter graph may display 31 dots.
limit.
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Quality Control

(2) QC Data
Figure 5-9.
In this screen, click “Group” to change group, click “Left” or “Right” to view next
page. Operator could review 31 items data at most. Click “DelAll” to delete all
the data.
The assay and limit are input and changed in QC Edit.
The QC data would be updated after running two new controls and the mean
value will be displayed.
Figure 5-9 XQC Data
55
Quality Control
5.2.4 X-R QC
5.2.4.1 X-R QC Run
On X-R QC screen click “Run”, enter QC Run screen as Figure 5-10.

At this screen, system displays two controls result and calculates the mean
value and range automatically. Click “Group” to switch group; click “Back” to
exit.
X QC needs control material. If run a background QC, the system will alarm
QC result is invalid
Figure 5-10 X-R QC Run
5.2.4.2 X-R QC Review
There are two ways to review QC result.

(1) QC Graph
Click “Back” on QC Run screen or select corresponding QC Mode in QC Mode
dialog box, enter X-R QC screen as Figure 5-11 in where operator can review
12 parameters QC results. The dot on X-R QC Graph indicates mean value or
range of two QC results. The system cannot display low, normal and high
control graphs simultaneously at one screen, please click “Group” to change.
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Quality Control
In X-R QC screen, there are X graph and R graph. X graph displays the mean
value dot while the R graph displays the range dot.
There are function buttons at the bottom of X-R QC screen. Click “Group” to
instance, WBC changes to RBC. Click “Level” to shift the classification line
between the X and R graphs. Click “Left” or “Right” to shift the classification
line in X or R graph. Click “Print” to print the current data.
Figure 5-11 X-R QC

X graph instruction:
3. Every parameter graph’s middle transverse line indicates X, mean
value of QC results.
4. Every parameter graph’s upper transverse line means X upper limit＝X
＋A×R.
5. Every parameter graph’s lower transverse line means X lower limit＝X
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Quality Control
－A×R.
 upper limit —— X upper limit＝X＋A×R
 middle line —— X
 lower limit —— X lower limit＝X－A×R
R graph instruction:
3. Every parameter graph’s middle transverse line indicates R, 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.
 upper limit —— R upper limit＝B×R
 middle line —— R
 lower limit —— R lower limit＝C×R
(2) QC Data
Figure 5-12.
On this screen, click “Group” to change group, click “Left” or “Right” to view
next page. Operator could review 31 items data at most. Click “DelAll” to delete
all the data.
X-R QC data screen can only display three controls result, and each one
contains mean and range. The first two lists on this screen are total mean and
average range. See Figure 5-12.
The QC data would be updated after running two new controls.
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Quality Control
Figure 5-12 X-R QC Data
5.2.5 X-B QC
5.2.5.1 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 in Figure 5-1 and click “OK” to enter the X-B QC screen, then
click “Edit” to enter X-B QC Edit screen as Figure 5-13.
On the bottom of this Edit screen, click “Del.” to delete current assay and limit;
click “OK” to save them; click “Back” to exit.
saved in database.
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Quality Control
Figure 5-13 X-B QC Edit
5.2.5.2 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
5-14. The “X-B QC Run” is selected to make the subsequent QC is X-B or not.
“Swatch number” is used to select the quantity of each group of samples. For
example, if the “X-B QC Run” is ON and “Swatch number” is 20, the
subsequent 20 controls count will be X-B QC counts.
Click “OK” to save the current selections.

After 20 times of count completed, back to the Run screen and click “COUNT”,
the system will calculate the results to reach a group of value and display in the
QC Graph and QC Data.
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Quality Control
Figure 5-14 X-B QC Run
5.2.5.3 X-B QC Review
The system offers two ways to review QC result.

(1) QC Graph
Click “Back” on QC Run screen or select corresponding QC Mode in QC Mode
dialog box, enter the X-B QC screen as Figure 5-15 in where operator can
review 3 parameters QC results. After the count of group samples completed,
the results of MCV, MCH, MCHC will depict a dot on the graph. For example,
the “X-B QC Run” is ON and “Swatch number” is 20, then after the subsequent
20 counts, the system will calculate a X-B QC value and a corresponding
control dot which will be displayed on the graph.
On the X-B QC screen, there are three graphs of MCV, MCH and MCHC. The
graphs will update at the same time of QC counting.
The function buttons are basically as the same as other QCs with additional
Pgpre and Pgnex.
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Quality Control
QC Graph instruction:
limit.
Figure 5-15 X-B QC

(2) QC Data
Figure 5-16. Click “Left” or “Right” to view the data on next page, operator
could review 30 items data at most. Click “DelAll” to delete all the data. The
Assay and Limit are input and changed in QC Edit.
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Quality Control
The QC data would be updated and added after running a new control.
Figure 5-16 X-B QC Data
63
Chapter 6 Calibration
To ensure the 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 the clinic or the laboratory.
5) Reagent has been replaced.
6) 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.
64
Calibration
6.1 Preparation for calibration
Before calibration, inspect the analyzer as following requirements:

1) Ensure the adequate reagents are in shelf life and uncontaminated.
2) Run a background test and make sure the results are qualified.
3) 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 result
precision in Query screen, make sure the CVs are within the prescribed
limits in Table 6-1.
Table 6-1
Parameter CV Range
WBC ≤2.0% 4.0×109/L～15.0×109/L
RBC ≤1.5% 3.00×1012/L～6.00×1012/L
HGB ≤1.5% 100 g/L～180g/L
HCT / MCV ≤1.0% / ≤0.5% 35%～50% / 76fL～110fL
PLT ≤4.0% 100×109/L～500×109/L
(1) Carryover is determined by running high control of WBC, RBC, HGB,

HCT and PLT. The high control is run in triplicate followed by three Diluent
running cycles. The percent carryover is calculated using the following
formula and result is conformed to Table 6-2.
Table 6-2 Carryover

Parameter Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
HCT ≤0.5%
PLT ≤0.5%
NOTE: If whole blood and capillary blood are both used in daily work,
Whole Blood Mode and Pre-diluent Mode should be calibrated before
processing samples.
65
Calibration
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.
6.2 Calibration Manually
At Main Menu Screen, click “Cal” to enter System Calibration screen as Figure
6-1.
Figure 6-1
Choose “manual Mode”, click “OK” to enter manual calibration interface. See
Figure 6-2.
Input assay and values, then click the New Cal button, the system will
calculate the new calibrated value automatically and the date will update
simultaneously.
66
Calibration
Figure 6-2
Click “OK” to save the new calibration values and a dialog box as Figure 6-3
shows will pop up.
Click “Print” to print the new calibration values.
Click “Back” to exit the System Cal.
Figure 6-3
 Click "NO" to save the new calibration values.
 Click "YES" to save the new calibration value and a dialog box as Figure
6-4 shows will pop up. Choose the animal group needed to be assigned
values.
67
Calibration
Figure 6-4
The counting principle of new calibration value:
 Mean value=(value1＋value2＋value3＋value4)/ 4
 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: The calibration coefficient is allowed in the range of 70%~130%, if
the test values exceed the limit; the maximum value in the limit range
should be selected as new coefficient for calibration.
NOTE: The analyzer can calibrate a certain parameter of WBC, RBC,
HGB, MCV, MPV, RDW_CV, RDW_SD, PLT and PDW. Also it can
calibrate all the parameters.
CAUTION: If any malfunction occurs during measurement, the test results
are invalid. Repeat the measurement after troubleshooting.
6.3 Calibration Automatically
At Main Menu Screen, click “Cal.” to enter System Calibration screen, Choose
“Automatic Mode”, click “OK” to enter automatic calibration interface. See
Figure 6-5.
68
Calibration
Figure 6-5 Automatic Calibration

At Automatic Mode, input assay, place the calibrator tube under the aspiration
probe, press RUN key, the analyzer starts to count, and displays the values in
Value 1 to Value 5 according to the sequence of 5 counts.
The analyzer cannot count or display the test value in this condition:
1. Press RUN key after 5 counts, the analyzer will prompt that there is no
space to process calibration count.
2. If the precision of test result is abnormal, the instrument will prompt “data is
abnormal, please re-counting”. After each counting, instrument 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.
The counting principle of Automatic Mode is the same as the Manual Mode.
NOTE: Click “OK” after counting and the system will save the values. Click
“Back” without clicking “OK”, the value will not be saved.
69
Chapter 7 Parameter Limit
To monitor abnormal blood sample measurement, it is essential for the

operator to setup normal ranges of the parameter according to laboratory or
clinical requirement. Information or indication is 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 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.
7.1 Limit Review
At Limit Setting screen, operator may input proper parameter limits or use the
default limits. Default limits are different depending on the animal group. Figure
7-1 depicts the Pig group limits. Grey input box indicates the parameter cannot
be provided by analyzer due to the particularity of blood sample.
Figure 7-1 Buffalo Group Limits
70
Parameter Limit
Click “Def.”, the system prompts the operator whether to recover all the default
limits. Select ‘Yes” to recover all groups of parameter to default limits; select
“No” to quit the operation. See Figure 7-2.
Figure 7-2 Recover to Default Limits
Click “OK” in Limit Setting to save the current default limits which will be
displayed when operator enter Limit Setting screen again.
7.2 Limit Modification
Operate as following procedures 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 current
group of parameters.
3. Select the lower or upper limit of the parameter that operator wanted to
modify, delete the former limit using the Backspace key on the
keyboard, input the new lower or upper limit.
4. Click “OK”, and then the dialog box as Figure 7-3 will display, select
“Yes” or “No” to save the modification or not.
Figure 7-3 Save the New Settings
7.3 Print
Click “Print”, then the system will print out limits of all groups in list form
automatically.
71
Chapter 8 Maintenance
Routine care and regular maintenance are essential to keep the best status
and precision, to minimize system problems, as well as to prolong the life span.
Procedures and instructions for preventive maintenance are discussed in this
chapter. More information is available at manufacturer Customer Support
Centre.
Preventive maintenance should be performed daily, weekly and monthly.
Pertinent maintenance is also included in this Chapter according to actual
requirement.
WARNING: Analyzer failure will occur unless a normative maintenance
criterion is performed strictly.
WARNING: Perform individual protection before instrument maintenance, such
as wear glove, respirator, lab coat etc.
8.1 Daily Maintenance
Analyzer is designed with daily auto-maintenance program. As in Figure 8-1,

operator can select the auto-clean time to maintain the system. Please refer to
Table 8-1 for time setting.
Table 8-1
Run time (hour) Time for auto-clean (hour)
>8 4
4< Run time<8 4
Run time< 4 2
72
Maintenance
Figure 8-1
8.2 Weekly Maintenance
8.2.1 Surface Maintenance
Clean the smudge on the surface of analyzer, especially the spilt 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.
CAUTION: Never use corrosive acids, alkali or volatile organic solvent (such
as acetone, aether and chloroforms) to wipe the outside of the analyzer, but
only litmusless Detergent.
8.3 Monthly Maintenance
Monthly maintenance mainly aims at mechanism maintenance, including

lubricate motor axis of dilution unit, X, Y leaders of sampling organ etc. The
procedures are as following:
73
Maintenance
1) Turn off the power according to the operation manual, and disconnect the
power cord.
2) Open the right side door; cover the sample cups with clean paper avoiding
contamination.
3) Clean up the greasy dirt on the X and Y leaders of the sampling organ,
leaders and motor axis of dilution unit with clean cotton or tissue.
4) Cut the grease with scissors and apply evenly appropriate amount grease
on the leaders and axis. Get rid of the redundant grease caused by grease
accumulation with cotton swab.
5) Take off the paper and close the right side door. Power on the analyzer and
run two background tests. End the maintenance procedures.
NOTE:
 Ensure the power of host is off before monthly maintenance,
 Do not try to move the sampling organ manually.
 Ensure there is no residual cotton or other foreign materials on the leaders
and motor axis.
 If there is crystal on the dilution unit or any other question, please contact
with manufacturer Customer Support Centre.
74
Maintenance
8.4 System Maintenance
At Main Menu Screen select “Func”, then select “Maint” to enter the screen like
Figure 8-2.
Figure 8-2 Maintain

Analyzer offers ten maintenance functions as follows:
 Cauterize Aperture
 Flush Aperture
 Drain Cups
 Rinse Cups
 Rinse Fluidics
 Prime Lyse
 Prime Diluent
 Prime Detergent
 Prime Fluidics
 Prepare Shipping
75
Maintenance
8.4.1 Cauterize Aperture
Cauterize Aperture may prevent and remove aperture clogs. Procedures 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. The operation is completed and back to the Maintain screen.
8.4.2 Flush Aperture
Flush Aperture may prevent and remove aperture clogs associating with
Cauterize Aperture. The procedures as follows:
1. Select “Flush Aperture” in Maintain screen.
8.4.3 Drain Cups
This operation will drain Diluent out of sample cups. The procedures as
follows:
1. Select “Drain Cups” in Maintain screen.
8.4.4 Rinse Cups
This operation may rinse the aperture to prevent blockage if the counting time
is too long. The procedures as follows:
1. Select “Rinse Cups” in Maintain screen.
76
Maintenance
8.4.5 Rinse Fluidics
CAUTION: Consider all clinical specimens, controls and calibrators etc. that
CAUTION: Consider the probe Detergent is corrosive, operator should wear
lab coats, gloves, and follow required laboratory or clinical procedures.
Probe Detergent is a kind of alkalescence Detergent. Performance of Prime
Fluidics is to rinse the WBC and RBC cups, and related tubing with probe
Detergent. If the analyzer is non-turnoff, perform Tubing Clean every three
days. If the analyzer is turnoff the power daily, perform Prime Fluidics every
week.
The procedures as follows:
1. Place the probe Detergent under the aspiration probe, making the
probe be able to aspirate the Detergent. Select “Prime Fluidics” at
Maintain screen.
2. Remove the Detergent after the probe retracted back. The analyzer
starts to perform the function and display the progress bar at the
bottom of the screen, the progress will take approximately nine
minutes.
8.4.6 Prime Lyse
NOTE: Keep the Lyse still for a certain time to ensure it stable.
NOTE: After replacement of 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 Lyse tubing.
 Replace a new Lyse.
77
Maintenance
The procedure is as follows:

1. Select “Prime Lyse” in Maintain screen.
8.4.7 Prime Diluent
NOTE: Keep the Diluent still for a certain time to ensure it stable.
test to make sure the background values in acceptable range.

 There are bubbles in Diluent tubing.
 Replace a new Diluent.
1. Select “Prime Diluent” in Maintain screen.
8.4.8 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
NOTE: Keep the Detergent still for a certain time to ensure it stable.
test to make sure the background values in acceptable range.

 There are bubbles in Detergent tubing.
78
Maintenance
 Replace a new Detergent.

1. Select “Prime Detergent” in Maintain screen.
8.4.9 Prime Fluidics
This operation may rinse the associated fluidics. The procedures as follows:
1. Select “Rinse Fluidics” in Maintain screen.
8.4.10 Prepare Shipping
Perform this function before shipping or leave unused for a long time. Refer to
the 8.5 section for details. The procedures as follows:
1. Select “Prepare Shipping” in Maintain screen.
8.5 Maintenance before Shipping
If the analyzer is leaved unused for three months or before shipping, maintain
the analyzer as following:
a) Take out the Diluent inlet tube connecting with Diluent port on the rear
panel from container, discharge the Diluent remained in tube.
b) Take out the Lyse inlet tube connecting with Lyse port on the rear
panel from container, discharge the Lyse remained in tube.
c) Take out the Detergent inlet tube connecting with Detergent port on
the rear panel from container, discharge the Detergent remained in
tube.
d) Keep the remaining reagents in their containers and store them
according to the instructions. Operator should establish and conform
79
Maintenance
to effective storage measures to prevent reagent from deteriorated,

misusage or misdrinking.
e) Keep the Diluent, Lyse and Detergent inlet tubes hang in the air.
f) At Main Menu Screen, click “Drain” several times until the top left
corner of the screen present No Diluent, No Lyse, No Detergent. Click
“Drain” once again.
g) Insert Diluent, Lyse and Detergent tubes into distilled water.
h) At Main Menu Screen, click “Func”, then click “Maint”, and then click
“Prepare Shipping”. See Figure 8-3.
Figure 8-3
i) After completed, take out the Diluent, Lyse and Detergent tubes from
distilled water and click “Prepare Shipping” again to drain the reagent
in tubes.
j) 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.
k) Pull out outlet tubes from the rear panel, clean it with distilled water
and save it with plastic bag after dry by airing.
l) Cover the connectors of DILUENT, LYSE, DETERGENT and WASTE
80
Maintenance
on the rear panel with caps which taken out at initial installation
m) Disconnect the power cord of analyzer and save it in plastic bag.
Place the analyzer and components in plastic bags into the shipping
carton.
81
Chapter 9 Service
This chapter introduces the Service function, with which operator may check
the system status, valve and motor status, etc. More information is available at
manufacturer Customer Support Centre.
CAUTION: Incorrect maintenance may lead to analyzer function impaired.
Please maintain the analyzer according to this manual.
NOTE: If there is any problems which cannot be find an answer in the manual,
please contact the manufacturer Customer Support Centre.
9.1 System Check
Click “Func” at Main Menu Screen, select “Sev”, input “2006” in the pop-up
dialog box to enter the System Check screen.
9.1.1 System Status Check
The System Status Check screen presents the current status information like
temperature, vacuum etc.. See Figure 9-1.
Figure 9-1 System Status Check
82
Service
NOTE: At System Status Check screen, operator may view the value of
temperature, vacuum, etc. but cannot modify these values.
Click “Back” to return to the Main Menu Screen.
9.1.2 Valve Check
At Valve Check screen (see Figure 9-2), the operator can check if the valves in
normal condition.
Figure 9-2 Valve Check

At Valve Check screen, click valve numbered, the corresponding results will be
displayed, and the corresponding valve sound can be heard. Click "Back" to
return to the main interface of the system.
9.1.3 Motor Check
At Motor Check screen, the operator can check if the motors in normal
condition. At the screen, click motor icon, the corresponding result will be
displayed, and the corresponding motor sound can be heard.
Click “P1” to test the vacuum pump, at the moment, the vacuum pump is
draining the waste.
Click "Back" to return to the main interface of the system. As shown in
Figure9-3.
83
Service
Figure 9-3 Motor Check
9.2 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 9-4.
Figure 9-4 System Log
84
Service
9.2.1 Date Query
Select Date on System Log screen, then click “Rev” the results will be
displayed in the list box. As shown in Figure 9-5.
Figure 9-5 Date Query
9.2.2 Event Query
On System Log screen, cancel Date option and select intended Event in
dropdown options, click “Rev”, results will be displayed in list as Figure 9-6.
Figure 9-6 Event Query
85
Service
After data and event query, the analyzer can do the following operations:
1. The total and current number of page of the system log will be
automatically displayed on the list box.
2. When there are too many queries, press “Pgprv” and “Pgnex” buttons, that
the system will automatically jump to the previous or next page and the
results will be displayed too.
3. Select a record, then press "Del.", that this record will be deleted.
4. Press "Del_All", all the records will be deleted.
5. Click ”Back" to return to the main interface of the system.
9.3 System Adjust
Click ”Func" at Main Menu Screen, select "Sev", input “1999” in the pop-up
dialog box to enter the System Adjust screen. As shown in Figure 9-7.
Figure 9-7 System Calibration
9.3.1 System Calibration
On the system calibration screen, user can adjust the parameters of the
motors and the count time of white blood and red blood cells. Each animal has
individual parameter value of blood. Animal group indicates current animal
86
Service
species. Click the motor item needed, analyzer will check its operation with the
setting value in right edit box
Set the values of the motors and the count time, then clik "OK", a dialog box as
Figure 9-8 shows will pop up.
Figure 9-8
 Click "NO" to save the setting value and exit Calibration screen.
 Click "YES", a dialog box as Figure 9-9 shows will pop up.
Figure 9-9
Operator is able to select one or more animal species that needed. Click "OK",
the values that user set will be saved in database. Analyzer will run according
to these values.
87
Service
9.3.2 Gain Adjust
Click "Gain Adjust" to enter the gain adjust screen. As shown in Figure 9-10.
Figure 9-10 Gain Adjust

On the Gain Adjust Screen, user can set the channel gains for WBC、RBC、
PLT and HGB. Click "OK" after setting, that the gains will be saved.
On the Gain Adjust Screen, users can also observe the background voltage
and Zero voltage.
NOTE : Users can not arbitrarily change the gain, or may cause abnormal data.
If needed, it must be adjusted by the manufacturer engineers or under the
guidance of manufacturer engineers.
88
Chapter 10 Troubleshooting
This Chapter gives instructions for identifying, troubleshooting, and correction

of analyzer problems. If malfunction are not solved according to guidance or
more information is needed, please contact manufacturer Customer Support
Centre.
10.1 Troubleshooting Guidance
The Troubleshooting Guidance is designed to assist the operator in identifying

and resolving analyzer problems. Instructions are also given for obtaining
technical assistance immediately from manufacturer Customer Support Centre.
The first step in the process is to understand normal analyzer operation and
preventive maintenance. Good experience of the analyzer is essential for
identifying and resolving operational problems. Logical troubleshooting may be
divided into three steps:
1. Problem Identification
2. Problem Isolation
3. Corrective Action
Step 1: Problem Identification means not only identifying what is wrong but
also what is right. The investigation should identify the problem area and
eliminate areas that are right. Once done, the trouble shooting process moves
quickly to next step.
Step 2: Problem Isolation means further classifying the problem. Analyzer
problems are generally divided into three categories:
1. Hardware component related

2. Software computer programs related
3. Measurement related to sample analysis
Hardware and software problems can only be corrected by a manufacturer

authorized engineer. The operator can correct sample measurement problems
89
Troubleshooting
with assistance from manufacturer engineers.

Step 3: Corrective Action means taking appropriate action to correct the
problem. If the operator can correct the problem, with or without technical
assistance from manufacture, normal operation can quickly resume.
10.2 Obtaining Technical Assistance
Technical Assistance is obtained by calling the manufacturer Customer

Support Centre. When assistance is needed, please be prepared to provide
the following information for Customer Support Specialists:
1. The analyzer Model
2. Serial number and version number
3. Description of the problem and surroundings, including status and
operation
4. The lot numbers of the reagents (lytic reagent, Diluent and Detergent)
5. Data and report of the problem
Familiar problems and disposals are given in this Chapter. The operator can
identify the cause according to the warning information and operate according
to Troubleshooting Guide.
10.3 Troubleshooting
Familiar problems and corrective actions are listed as follows. If the problems
can not be corrected, or technical assistance is needed, please contact with
manufacturer Customer Support Centre.
90
Troubleshooting
10.3.1 Faults Related to Reagents
Fault Probable Cause Corrective Action
1. Lyse is run out or 1. Check that if the Lyse is run out.

Lyse inlet tube is 2. Perform Func → Maintain →Prime
Lyse Lyse.
blocked.
Empty 3. If fault still occurs, please contact with
2. Lyse inlet tube manufacturer.
has bubbles.
1. Diluent is run out. 1. Check that if the Diluent is run out.

2. Diluent inlet tube 2. Perform Func → Maintain →Prime
Diluent
has bubbles. Diluent.
Empty
3. If fault still occurs, please contact with
manufacturer.
1. Detergent is run 1. Check that if the Detergent is run out.

out 2. Perform Func → Maintain →Prime
Detergent
Empty 2. Detergent inlet Detergent.
tube has bubbles. 3. If fault still occurs, please contact with
manufacturer.
1. Check that if the waste is full.
Waste container is full 2. Check that if the sensor is wet or short
Waste or waste sensor is in
circuit.
Full fault.
manufacturer.
10.3.2 Faults Related to Vacuum
1. Click “Sev”, input password 2006 to

The vacuum doesn’t enter System Check screen, ensure the
Low reach the standard
vacuum items are in normal condition.
Vacuum value.
manufacturer.
91
Troubleshooting
10.3.3 Faults Related to 5V Voltage
1. Click “Sev”, input password 2006 to enter

Power supply System Check screen, ensure the 5V
5V Voltage module
Voltage in normal condition.
Problem abnormal.
manufacturer.
10.3.4 Faults Related to Test Value
1. Check that if the Diluent is overdue or

Diluent is contaminated.
contaminated or 2. Enter Maintain screen and perform Rinse
overdue; Diluents Fluidics.
High tube or cups 3. If fault occurs, Perform Prime Fluidics at
Background contaminated. Maintain screen using probe Detergent.
Value
Run a background test again to check if
the fault disappeared.
manufacturer.
1. Click “Sev”, input password 2006 to enter

1. HGB System Check screen, check the
background HGB_BACK and HGB_ZERO.
voltage 2. If the HGB_BACK and HGB_ZERO are
HGB
hopping out of range, contact with manufacturer to
Inaccuracy
2. Sample cup is modify the values.
dirty. 3. Perform Prime Fluidics and then run a
background test to check if the
HGB_BACK issatisfactory.
92
Troubleshooting
1. Perform Cauterize Aperture or Flush

Ruby aperture Aperture in Maintain, and then run a
clogged; WBC background test to check the counting
WBC Clog counting time time.
or incorrect; solenoid 2. If fault occurs, perform Prime Fluidics in
RBC Clog
valve problem Maintain.
manufacturer.
1. Diluent or 1. Check the Diluent and Detergent.

Detergent run 2. Check the reagent tubing connection,
WBC bubble out or deficient prevent leakage.
or 2. Reagent 3. Perform Rinse Fluidics in Maintain.
RBC bubble tubing loose 4. If fault still occurs, please contact with
leads to manufacturer.
leakage
10.3.5 Faults Related to Hardware
1. motor 1. Click “Sev”, input password 2006 to

connecting wire enter System Check screen, ensure the
loose motor items are in normal condition.
Motor 2. travel switch 2. If fault still occurs, please contact with
sounds problem manufacturer.
abnormally. 3. motor problem
4. motor drive
circuit problem
1. Ruby aperture 1. If the fault occurs after eliminate the

clogged. aperture clog, click “Sev”, input
Counting
time is too 2. Valve no password 2006 to enter System Check
long or no movement. screen, ensure the Valves are in normal
counting condition.
time. 2. If fault still occurs, please contact with
manufacturer.
93
Troubleshooting
10.3.6 Faults Related to Temperature
1. Click “Sev”, input password 2006 to

Temperature enter System Check screen, check the
abnormal or temperature in System Status Check.
temperature 2. If the temperature is out the range of
Temperatur sensor problem. 15℃-30℃, please adjust the air
e abnormal
conditioner to ensure the temperature
is in the range.
manufacturer.
94
Chapter 11 Precautions, Limitations and Hazards
Improper operation will never attain optimal performance; even cause damage
to the operator or others. To avoid the damage and get a successful
measurement, a criterion should be designed to perfect the service conditions.
11.1 Limitations
1) Analyzer is designed for in vitro diagnostic use.

2) Any operation, shipment, installation or maintenance to the analyzer must
strictly follow the contents outlined in this manual, or if any problems
derived from that, manufacturer will not offer free warranty.
3) manufacturer has designed the instrument system components for optimal
performance. Substitution for reagents, controls and calibrators and
components recommended by other companies may adversely affect the
performance of the analyzer or cause incidents, thus lose the free
warranty.
4) Any repairing must be permitted and any accessory replacement must be
specified by manufacturer, if any problems derived from that, manufacturer
will not offer free warranty.
5) Follow the recommended maintenance schedules and procedures as
outlined in Chapter 8. Any incompliance will shorten the life span and
affect the test results, or cause incidents, thus lose the free warranty.
11.2 Location Limitations
1) A manufacturer authorized Engineer must perform the initial installation.

2) Place the analyzer on a stable, level surface. Locate the system
 Away from direct sunlight.
 Away from path of a cooled or heated air outlet with temperature
extremes.
 Away from drying ovens, centrifuges, x-ray equipment, copiers or
ultrasonic cleaner.
3) Place the reagent containers on the same level as the analyzer.
4) Adequate space should be provided around the analyzer. 40cm of space
95
Precautions, Limitations and Hazards
from the surrounding objects is needed for proper ventilation, and 2m 2

space is needed for the analyzer and the reagent. Please do not placed
the instrument in the location where difficult to operate the disconnect
device. Adequate space should be provided around the analyzer to
perform necessary maintenance procedures.
5) Before operating the analyzer for the initial measurement, verify that each
reagent tuning is connected to the appropriate inlet and reagent container.
Make sure the outlet tubing is not twisted and the waste tubing is
connected to the appropriate outlet and routed to a suiTable waste
container or drain.
6) Do not disconnect any electrical connection while the power is ON. Verify
the analyzer is well connected with the ground to prevent electrical
interfere and ensure the safety.
CAUTION: Anyone without authorization of manufacturer should NOT remove

the screws on the cover, or the customer must take all the responsibility.
11.3 Safety and Infection Control
1) Follow required laboratory or clinical procedures during daily operation or

maintenance. Wear gloves, lab clothing and safety glasses to avoid direct
contact to the samples.
2) Consider all clinical specimens, controls and calibrators etc. as potentially
infectious. Wear standard laboratory clothing, gloves and safety glasses
and follow required laboratorial or clinical procedures when handling these
materials. Do not smoke, eat or drink at working area. Do not suck or blow
the tubing.
3) Consider the blood samples and waste have potential source of biological
and chemical hazard, the operator should handle with extreme care during
the disposal process and follow criterion of the local government when
cleaning, handling, discharging.
4) Follow the manual to store reagent, calibrators and controls. The customer
have obligation to take actions and management to prevent the reagent,
calibrators and controls from deterioration, misapplication or eating by
mistake. The reagent should be away from temperature extremes.
96
Precautions, Limitations and Hazards
CAUTION: Reagent will freeze when it is below 0℃, for which the reagent can
not be used.
CAUTION: Keep the reagents away from direct sunlight to avoid evaporation
and contamination. Seal the cap of the container. Minimize the diameter of the
hole to avoid evaporation and contamination.
97
Appendix A: Instrument Specifications
Dimension and Weight Environmental Requirements

Dimension: Temperature: 15℃~35℃
650mm(L)×470mm(W)×600mm(H) Relative Humidity: ≤90%RH
Weight: 28Kg Barometric: 60kPa~106kPa
Transport and Storage Specifications Power Specifications

Temperature: -10℃~55℃ Power Supply: AC 100V～240V
Relative Humidity: ≤95%RH Frequency: 50/60Hz
Barometric: 50kPa~106kPa Power: 130VA-180 VA
Fuse: 250V/3A
Application Scope: Animal venous blood & peripheral blood
Appearance Specifications
Display: 10.4-inch LCD with a resolution of 640 × 480
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
Sample Volume
Whole Blood Mode: Whole Blood 10μL
Pre-diluent Mode: Capillary Blood 20μL
Reagent Volume for Single Sample

Diluent: 31mL
Detergent: 8mL
Lyse: 0.7mL
97
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
Linearity
Table A-3 Linearity Specifications

Parameter Linearity Range Acceptable Limits
0×109/L~10.0×109/L ≤±0.3×109/L
WBC
10.1×109/L ~99.9×109/L ≤±5%
0×1012/L ~1.00×1012/L ≤±0.05×1012/ L
RBC
1.01×1012/L ~9.99×1012/L ≤±5%
0 g/L ~70 g/L ≤±2g/L
HGB
71 g/L ~300 g/L ≤±2%
0×109/L ~100×109/L ≤±10×109/L
PLT 101×109/L ~999×109/L ≤±10%
98
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
Environmental Friendly Use Period
Manufacturer
Metrology Certification
99
Appendix C: Toxic and Hazardous
Substances or Elements
Toxic and Hazardous Substances or Elements

Polybromi-
Polybrominated
Parts Plumbum Mercury Cadmium Chromium nated
Diphenyl
(Pb) (Hg) (Cd) VI(Cr(VI)) Biphanyls
Ethers（PBDE）
(PBB)
Shell ○ ○ ○ ○ ○ ○
Printed
Circuit
× ○ ○ ○ ○ ○
Board
Assembly
Sheet
Metal ○ ○ ○ × ○ ○
Parts
Host Plastic
○ ○ ○ ○ ○ ○
Parts
Machining
○ ○ ○ ○ ○ ○
Parts
Hardware ○ ○ ○ ○ ○ ○
Flow
System ○ ○ ○ ○ ○ ○
Parts
Cable ○ ○ ○ ○ ○ ○
Accessories ○ ○ ○ ○ ○ ○
Packaging
○ ○ ○ ○ ○ ○
Materials
○：The content of toxic or hazardous substance in the homogeneous materials of the parts
above is in the acceptable range of SJ/T11363-2006.
× ： The content of toxic or hazardous substance is exceed the acceptable range of
SJ/T11363-2006 in at least one kind of homogeneous material of the parts above.
(The circuit board used lead solder in machining process and some parts of the board contain
plumb；And some sheetmetal parts use chromium VI for surface ）
Memo ： Printed circuit board Assembly is consist of printed circuit board, capacitance,
connector and other parts. Lithium cell is detachable and recyclable part.
100

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1) Carefully read this manual before first operation.

2) Inspect electrical requirements of analyzer before power on, and

3) Turn off the power of analyzer and disconnect power cord if

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

5) There is potential biohazard of reagents and samples; operator should

2.7 HGB Colorimetric Method ........................................................... 17

4.5 Time Setting ................................................................................ 44

9.2 System Log ................................................................................. 84

Copyright © URIT Medical Electronic Co., Ltd.

All the information included is protected by copyright. No part of this document

All instructions must be followed strictly in operation. In no event should URIT

Limited Responsibility for Quality Warranty:

Technical service and troubleshooting are provided by the Service Department

URIT Medical Electronic Co., Ltd.

Supplied By: URIT Medical Electronic Co., Ltd.

Wellkang Ltd t/a Wellkang Tech Consulting

General information for the operation of the analyzer is contained in this

This manual uses the following warning conventions:

Do read through this manual before operation, maintenance,

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

The Analyzer is a multi-parameter, automated hematology analyzer designed

The Analyzer uses Coulter electrical impedance and colorimetry methods to

1.1.2 Intended Use

The Analyzer is appropriate to the qualitative and quantitative analysis of the

1.1.3 Front Panel

Alarm Information Mode System Time

Display functional menus which fall into two categories.

Second category menus as Figure 1-4:

1.1.4 Rear Panel

1. COM1 and COM2

The analyzer consists of flow system, electrical system, display etc.

1.3.1 Flow System

1.3.2 Electrical System

1.3.2.1 ARM Board

ARM board is a hardware platform for Linux embedded system, a control

1.3.2.2 FPGA Driver Board

eliminate clogs, aspirate and discharge reagents.

1.3.2.3 LMS Board

LMS board is a volume measurement board, measuring a volume of blood

1.3.2.4 Front-end Signal Panel

It is used to collect various signals, such as count electrical pulse, light

1.3.2.5 Switch Power Supply

1.3.2.6 Front-end Power Panel

1.3.2.7 Valve and Motor Driver Board

1.3.2.8 WBC/RBC/PLT Metering Assembly

WBC Metering Assembly is composed of signal collection board, electrodes,

Analyzer uses a 10.4-inch LCD which displays 21 parameters and 3

1.5 Sample Volume

Whole Blood Mode: Whole Blood 10 μL

1.6 Reagent Volume for Single Sample

1.7 Test Speed

Analyzer is able to process 30 samples per hour.

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

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

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

1.14 Transport and Storage Specifications

1.15 Environment Requirement

1.16 Electrical Requirement

Power Supply: AC 100V～240V

Reagent is formulated specifically for Analyzer flow systems in order to provide

Reagents must be stored at room temperature to ensure optimal performance.

Diluent is a kind of reliable isotonic Diluent to meet the requirements as