URIT 5500 Opeation Manual (V2 0 2012 12 20

Five-Part-Diff Auto Hematology Analyzer
URIT-5500
Operator’s Manual
URIT Medical Electronic Co., Ltd.

NOTE:
1) Carefully read this manual before first operating the analyzer.

2) Inspect the electrical requirements of the analyzer before power on,
and properly connect the grounding wire.
3) Turn off the power to the analyzer and disconnect the power cord if the
analyzer is idle for a long time.
4) Do not run the analyzer if it’s in an abnormal or damaged condition.
5) There is potential biohazard of the reagents and samples; operator
should follow proper biosafety practices. Dispose of waste reagent and
sample in accordance with local, national regulations.
I
Contents
Chapter 1Introduction .......................................................................................................... 1
1.1 Overview ................................................................................................................. 1
1.2 Hazard Sign ............................................................................................................ 1
1.3 Guidance ................................................................................................................ 3
1.4 Parameters ............................................................................................................. 4
Chapter 2 Safety Information for Operation ........................................................................ 6
2.1 Overview ................................................................................................................. 6
2.2 Special Requirements ............................................................................................ 6
2.3 General Requirements ........................................................................................... 6
2.4 Electromagnetism Security..................................................................................... 7
2.5 Installation............................................................................................................... 7
2.6 Antipollution ............................................................................................................ 8
2.7 Reagent .................................................................................................................. 8
2.8 Maintenance ........................................................................................................... 9
2.9 Laser ....................................................................................................................... 9
2.10 Consumables...................................................................................................... 10
2.11 Security Sign ....................................................................................................... 10
2.12 Operators............................................................................................................ 11
2.13 Computer Virus................................................................................................... 12
Chapter 3 System and Function ........................................................................................ 13
3.1 Overview ............................................................................................................... 13
3.2 Parameter ............................................................................................................. 13
3.3 Structure ............................................................................................................... 15
3.4 Counting Operation Screen .................................................................................. 23
3.5 Reagent, Control and Calibrator .......................................................................... 24
3.5.1Diluent................................................................................................................. 25
3.5.2 Sheath ............................................................................................................... 25
3.5.3 Lyse ................................................................................................................... 26
3.5.4 Detergent ........................................................................................................... 26
3.5.5 Probe Detergent ................................................................................................ 26
3.5.6 Control and Calibrator ....................................................................................... 27
Chapter 4 Installation ......................................................................................................... 28
4.1 Overview ............................................................................................................... 28
4.2 Unpacking and Inspection .................................................................................... 28
4.3 Space Requirements ............................................................................................ 29
4.4 Power Supply Requirements ................................................................................ 29
4.5 Environment Requirements .................................................................................. 29
4.6 Waste Requirements ............................................................................................ 30
4.7 System Installation ............................................................................................... 30
4.7.1 Computer Installation ........................................................................................ 30
4.7.2 Tubing Installation.............................................................................................. 31
4.7.3 Printer Installation .............................................................................................. 32
I
4.8Transport and Storage Requirement ..................................................................... 32
Chapter 5 Principles of Operation ..................................................................................... 33
5.1 Overview ............................................................................................................... 33
5.2 Sample Aspiration................................................................................................. 33
5.3 Sample Dilution .................................................................................................... 33
5.3.1 Whole Blood Automated (Batch) Sampling Mode ............................................. 34
5.3.2 Whole Blood Single (Emergency) Sampling Mode. .......................................... 35
5.4 WBC Test Principle ............................................................................................... 36
5.4.1Four-Angle Laser Light Scatter Technology ....................................................... 36
5.4.2 White Blood Cell Differential.............................................................................. 39
5.5 Hemoglobin Concentration Test Principle ............................................................ 40
5.5.1 Colorimetry Principle ......................................................................................... 40
5.5.2 HGB Parameter ................................................................................................. 41
5.6 Red Blood Cell /Platelet Test Principle ................................................................. 41
5.6.1 Electrical Impedance Principle .......................................................................... 41
5.6.2 Volumetric Metering........................................................................................... 42
5.6.3 Red Blood Cell Parameters ............................................................................... 43
5.6.4 Platelet Parameters ........................................................................................... 44
Chapter 6 Settingss ........................................................................................................... 45
6.1 Overview ............................................................................................................... 45
6.2 Time Setting.......................................................................................................... 45
6.3 System Maintenance ............................................................................................ 46
6.4 Dictionary Maintenance ........................................................................................ 50
6.5 Barcode Information ............................................................................................. 52
6.6 Sampler ................................................................................................................ 53
6.7 Display Setting...................................................................................................... 54
6.8Print Setting ........................................................................................................... 56
6.9 Transfer Setting .................................................................................................... 56
6.10 Group Parameters .............................................................................................. 58
6.10.1 Limit Review .................................................................................................... 58
6.10.2 Limit Modification ............................................................................................. 60
6.11 User Management .............................................................................................. 60
6.12 Permission .......................................................................................................... 62
Chapter7 Daily Operation .................................................................................................. 64
7.1 Overview ............................................................................................................... 64
7.2 Preparations ......................................................................................................... 64
7.3. Startup ................................................................................................................. 65
7.4 Quality Control ...................................................................................................... 67
7.5 Collection of Blood Samples ................................................................................ 67
7.5.1 Whole blood collection ...................................................................................... 67
7.5.2 Sample stability ................................................................................................. 68
7.6 Information Input................................................................................................... 68
7.7 Sample Counting .................................................................................................. 70
7.7.1 Mode .................................................................................................................. 70
II
7.7.2 Counting and Analysis ....................................................................................... 71
7.8 Data Query and Output ........................................................................................ 71
7.8.1 Data Query ........................................................................................................ 71
7.8.2 Data Selection ................................................................................................... 73
7.8.3 Data Deletion ..................................................................................................... 75
7.8.4 Precision ............................................................................................................ 75
7.8.5 Trend Graph ...................................................................................................... 76
7.9 Reticulocyte Analysis ............................................................................................ 77
7.9.1 Principles of Operation ...................................................................................... 78
7.9.2 Reticulocyte Sample Preparation ...................................................................... 80
7.9.3 Reticulocyte Test ............................................................................................... 80
7.10 Statistic ............................................................................................................... 82
7.11 Shutoff................................................................................................................. 83
Chapter 8 Quality Control .................................................................................................. 84
8.1 Overview ............................................................................................................... 84
8.2 Quality Control Options ........................................................................................ 85
8.3 QC Operation ....................................................................................................... 86
8.4 L-J QC .................................................................................................................. 87
8.4.1 L-J QC Edit ........................................................................................................ 87
8.4.2 L-J QC Run........................................................................................................ 88
8.4.3 L-J QC Graph Analysis ...................................................................................... 89
8.4.4 L-J QC Data Query ............................................................................................ 89
8.5 X-B QC ................................................................................................................. 90
8.5.1 X-B QC Edit ....................................................................................................... 91
8.5.2 X-B QC Run....................................................................................................... 91
8.5.3 X-B QC Graph Analysis ..................................................................................... 92
8.5.4 X-B QC Data Query ........................................................................................... 93
8.6 X-R QC ................................................................................................................. 94
8.6.1 X-R QC Edit ....................................................................................................... 94
8.6.2 X-R QC Run ...................................................................................................... 95
8.6.3 X-R QC Graph Analysis..................................................................................... 95
8.6.4 X-R QC Data Query .......................................................................................... 97
8.7 X QC ..................................................................................................................... 98
8.7.1 X QC Edit........................................................................................................... 98
8.7.2 X QC Run .......................................................................................................... 99
8.7.3 X QC Graph Analysis ...................................................................................... 100
8.7.4 X QC Data Query ............................................................................................ 101
Chapter 9 Calibration ....................................................................................................... 103
9.1 Overview ............................................................................................................. 103
9.2 Calculate Frequency .......................................................................................... 104
9.3 Preparation for Calibration ................................................................................. 105
9.4 Calibration Mode ................................................................................................ 106
9.4.1 Calibrated Calibration ...................................................................................... 106
9.4.2 Whole Blood Calibration .................................................................................. 108
III
9.4.3 Manual Calibration .......................................................................................... 110
Chapter 10 Maintenance ................................................................................................. 114
10.1 Overview ........................................................................................................... 114
10.2 Routine Maintenance ....................................................................................... 114
10.2.1 Daily Maintenance ......................................................................................... 114
10.2.2 Weekly Maintenance ..................................................................................... 115
10.2.3 Monthly Maintenance .................................................................................... 116
10.3 Maintenance procedure.................................................................................... 117
10.3.1 Prime All ........................................................................................................ 118
10.3.2 Prime Lyse ..................................................................................................... 119
10.3.3 Prime Diluent ................................................................................................. 120
10.3.4 Prime Detergent ............................................................................................ 120
10.3.5 Prime Sheath ................................................................................................. 120
10.3.6 Cauterize Aperture ........................................................................................ 121
10.3.7 Flush Aperture ............................................................................................... 121
10.3.8 Clean Transducers ........................................................................................ 122
10.3.9 Prepare Shipping ........................................................................................... 122
10.3.10 Other Maintenances .................................................................................... 123
Chapter11 Troubleshooting.............................................................................................. 125
11.1 Overview ........................................................................................................... 125
11.2 Troubleshooting Guidance................................................................................ 125
11.3 Obtaining Technical Assistance ........................................................................ 126
11.4 Troubleshooting ................................................................................................ 126
11.4.1 Faults Related to Reagents ........................................................................... 127
11.4.2 Faults Related to Test Value .......................................................................... 128
11.4.3 Fault Related to Hard Ware ........................................................................... 129
Appendix A Specifications ................................................................................................ 130
A.1 Technical Specifications ..................................................................................... 130
A.1.1 Parameters...................................................................................................... 130
A.1.2 Test Speed ...................................................................................................... 131
A.1.3 QC Mode ......................................................................................................... 131
A.1.4 Reagents of Product ....................................................................................... 131
A.1.5 Calibration Mode ............................................................................................. 131
A.1.6 Parameters Measurement and Calculation .................................................... 131
A.1.7 Input/Output Devices ...................................................................................... 131
A.2 Physical Specifications....................................................................................... 132
A.2.1 Power Requirement ........................................................................................ 132
A.2.2 Environment Requirement .............................................................................. 132
A.2.3 Storage Environment ...................................................................................... 132
A.2.4 Size and Weight .............................................................................................. 132
A.2.5 Waste Disposal ............................................................................................... 132
A.2.6 Minimum Sample Volume ............................................................................... 133
A.2.7 Dilution Ratio ................................................................................................... 133
A.2.8 Counting Aperture ........................................................................................... 133
IV
A.2.9 HGB measurement ......................................................................................... 133
A.3 Performance Index ............................................................................................. 133
A.3.1 Precision ......................................................................................................... 133
A.3.2 Linearity ........................................................................................................... 134
A.3.3 Accuracy of WBC five part differential ............................................................ 134
A.3.4 Carryover ........................................................................................................ 134
A.3.5 Background Counting ..................................................................................... 134
A.3.6 Accuracy.......................................................................................................... 135
A.3.7 Display Range of Main Parameter .................................................................. 135
A.4 Reagent Specifications ...................................................................................... 135
A.5 Reagent Consumption ....................................................................................... 136
A.6 Parameters Alert Messages ............................................................................... 136
Appendix B Toxic and Hazardous Substances or Elements ........................................... 137
Appendix C Daily Operation Procedure .......................................................................... 138
V
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-5500 Auto
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-5500 Auto 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-5500 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 analyzer life is ten years.
URIT assumes no liability in the following situations even during the period of
warranty:
a) Failure due to abuse the analyzer 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.
VI
CAUTION:
THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE
ONLY.
Technical service and troubleshooting are provided by URIT Customer Support
Center. Professional technician and sale representative will be sent to offer
you timely service when necessary.
URIT Medical Electronic Co., Ltd.

No.4 East Alley, Jiuhua Road, Guilin, Guangxi 541001, PR China
Tel: +86（773）2288586
Fax: +86（773）2288560
Web: www.urit.com
Email: service@uritest.com
Supplyed by URIT Medical Electronic Co., Ltd.
Wellkang Ltd t/a Wellkang Tech Consulting

Suite B 29 Harley Street, LONDON W1G 9QR, UK
Version : 01/2011
VII
Chapter 1 Introduction
1.1 Overview
URIT-5500 Five-Part-Diff Auto Hematology Analyzer is an in vitro diagnostic

medical device. It can analyze and output 30 parameters of the a specimen
(including 6 graphics). The Optical detection section uses He-Ne laser to
analyze the five part differential of white blood cells, Coulter theory for the
amount of red blood cells and platelet, and colorimetry for hemoglobin
concentration.
NOTE
 Read this instruction carefully before operating, especially the safety
information. Please keep this manual properly for future reference.
 If the user does not operate the instrument according to operation manual,
misemployment will lead to inaccurate measurement and cause
misdiagnosing, delaying patient’s treatment or doing harm to the operator
himself, even damaging the instrument.
 Any attempt to brief, optimize, improve or elide expected activities which
listed in operation manual will be likely to cause some negative impact on
the precision of instrument.
 User must follow the instruction strictly when they he operating the medical
instrument.
1.2 Hazard Sign
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 the operator should follow the instruction under this symbol, or it may
have a personal injury.
1
Introduction
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.
WARNING
Denotes potential bio-hazard.
WARNING
Denotes a laser hazard which, if non-compliance with procedures or
engineering controls, may result laser damage to eyes.
NOTE
Denotes special operator/service information or standard practices.
Do read through this manual before operation, maintenance,
displacement to the analyzer.
2
Introduction
1.3 Guidance
This manual contains general information, which is the best guidance for new
operators. Please read this manual thoroughly at the first use. You can use
contents to quickly find the required information in daily use. All related
personnel should read this manual.
This manual includes 11 chapters and 3 appendices. Operator can find the
information needed according to the table.
Information Reference
Parameters Chapter 1 Introduction
Notices for Operation Chapter 2 Safety Information for
Operation
Structure and Use Chapter 3 System and Function
Installation Chapter 4 Installation
Measurement Principle and Procedure Chapter 5 Principles of Operation
System Parameter Setting Chapter 6 Settings
Daily Operations Chapter 7 Daily Operation
Requirement and Method of QC Chapter 8 Quality Control
Requirement and Method of Calibration Chapter 9 Calibration
Maintenance Chapter 10 Maintenance
Troubleshooting Chapter 11 Troubleshooting
Detailed Specification Appendix A Specifications

Daily Operations Procedure Appendix B Manufacturing
Measuring Apparatus License
3
Introduction
1.4 Parameters
Item Content Explanation

Test Pa rameter 34 parameters (wi th g raphics) Scatte r diagram , histogram ,
three -dimensional plot
Opera tion Closed sampling. Special intelligent Avoid directly contact with samples
recognition test tube rack allows and ensure safety.
sampling continuously. A batch of 120
samples can be handled at a time, and
the emergency sample can be inserted
at any time.
Language English Software suppo rts on line and U
disk upgrade.
Display Setting Equipped wi th brand compute rs Data management and networking are
and LCD monitors. convenient.
Data Storage ≥ 200 000 test results (with graphics )
Speed Single (emergency) s ampling 100 / h
Continuous (ba tch) s ampling 110 / h
Outpu t Mode External p rinte r, Choose to Reference range can be prin ted
print the histogram. Different out in a English report format.
w a r n i n g s i g n s p r o mp t p r o b a b l e
abnormalities of specimen.
Blood Volume Whole blood (batch) automated Anticoagulation wi th
sampling mode 160 µL±put5％ EDTA-K2/EDTA -K3.
Whole blood single (emergency)
sampling mode 160 µL±5％

Reagent Diluent, de tergen t, lyse (non-toxic environment-friendly reagents), sheath
Sample Use the automati c washing Avoid samples c ross

Aspiration device to flush the inside and contamination and o perato rs
Probe Rinsing outside wall of sample aspira tion contacting the samples.
probe.
Blood Rotate shea r valve High precision, wea r -re sistant .
Separation Tak e the middle blood and
exhaust the in terference from
bubbles and ca rryo ve r.
Unit Selection With two units selection for WBC, RBC, Meet the parame ters unit
HGB, PLT and other items.。 requests fo r differen t coun tries
and places.
4
Introduction
HGB Tes t Cyanide-free qua te rn ary Environmental reg ents can

ammonium salt hemoglobin . avoid the e ffects of o pera tors'
LED light source , 5 40nm health, and be good for
wa velength colorimetry. environmental pro tection. If u se
the toxic reagents , you need to
purchase specialist processing
equipment, which wi ll increase
costs.
Control and With calibrator, fresh blood and manual calibration; With LJ, X, XR, XB control
Calibration mode etc.
C oeff icient of W BC ≤1.5% Linearity W BC： 0.0×109 /L -99 .9×109 /L
Variation RBC ≤1.0% RBC： 0.1×1012 /L -7 .0 0×1012 /L
HGB ≤1.5% HGB： 0 g /L-300g /L
MCV ≤1.0% PLT： 0×109 /L -999×109 /L
HCT ≤2.0%
PLT ≤4.0%
Adopt separately removable Enhance accurac y a nd maintain easily
syringe structure.
Structu re
W ith automatic Improve the lifetime of equipment, and

m o n i to ri n g f u n c ti o n to maintain the bes t wo rk ing conditions
prompt the opera tor
Maintenance to perform automatic
m a i n te n a n c e o r t r o u b l e
shooting proc edures .
With 9 different groups normal Can be adjusted according to different

Reference range parameter setting geographical groups; and the instrument will
Range function. automatically identify and match the best
reference.
Flush High-voltage cautery. Removable ruby aperture plate is easy to clean. Positive
and negative pressure recoil and intelligent automatic cleaning.
Security Have a good electrical security with the flow electricity isolation system.
Host Size 760MM×684MM×676.5MM( length × width × height )
Power ≤600VA
Fuse 250V/2.5A
weight About 91 .5k g
5
Chapter 2 Safety Information for Operation
2.1 Overview
In addition to the safety use information, the general matters of operators in

terms of security are also shown in this chapter. Please read this chapter
carefully before operation.
2.2 Special Requirements
 URIT-5500 five-Part-Diff Automated Hematology Analyzer is for blood cell

count, WBC five part differential and hemoglobin concentration
measurement in clinical laboratory.
 Only allow to use the reagents and detergents mentioned in this manual.
Operating requirements also include regular cleaning and maintenance.
2.3 General Requirements
 Read the operation manual before using. Understand all the important
signs. Please keep manual for future reference.
 Following the manual instructions to start the analyzer, otherwise the
functions of the analyzer will lose due to accidental mechanical damage
and undesirable environment.
 The instrument must be operated in accordance with the methods
mentioned in this manual strictly.
 Keep long hair, fingers and clothes away from rotating parts with a certain
distance.
 Turn off the power switch and unplug the power cord immediately if the
instrument gives off odor or smoke, otherwise it will cause fire, electric
shock or injury. If this happens, please contact the after-sale service
department.
 Do not spill the samples or reagent and do not let other things fall into the
instrument, otherwise it will cause short circuit. If this happens, turn off the
power switch and unplug the power cord immediately, then contact the
after-sale service department.
 Do not touch the circuit, especially a wet hand, which will cause electric
6
Safety Information for Operation
shock.
electric shock.
 The analyzer must be connected to a receptacle with correct voltage, and
grounding at the same time.
 Avoid damaging the power cord. Do not put any device upon the power
cord. Do not pull the power cord.
 Turn off the power before connecting other devices (host computer,
printer).
 The instrument is connected with AC power. There is a hazardous voltage
symbol in the interface. using power adapters of other brands may cause
wrong test results due to the substandard technique data.
2.4 Electromagnetism Security
 The motor is inside the instrument, it will produce alternative electric field
and magnetic field.
 The instrument may not function properly due to the strong
electromagnetic interference.
 It may cause data conversion errors and incorrect results due to strong
electromagnetic interference and poor grounding.
2.5 Installation
 The analyzer must be installed in dry and dust-free place. Avoid placing in
the place where is wet and with poor ventilation or in the dirty air with salt
and sulfur. Since the shell material is ABS + PC, it will be corrupted if being
placed in a high pH environment.
 Avoid splashing water on the analyzer.
 Do not expose the instrument to the place with large temperature
difference and direct sunlight.
 Avoid vibration. The instrument should be put into the box with foam to
prevent damage during storage and transport. Improper package may lead
to abnormal operation of the instrument.
 Installation site must be well ventilated.
 This instrument does not produce ionizing radiation, but we should take
other equipments that generate strong ionizing radiation into consideration,
such as X-ray, γ-ray which may cause test results errors.
7
 The equipment should not be installed in the place where stores chemicals
and generates gas.
 The frequency and voltage required should be consistent with those in the
instruction and have the ability to allow current. The instrument should be
equipped with precision power supply or UPS.
 The equipment is about 90kg, falling may cause injury during carrying.
 Wrong reagent or incorrect operation may cause wrong results.
2.6 Antipollution
 All the components and surface of the instrument have the potential
infectivity. The sample probe should keep an appropriate distance from the
surrounding objects in order to facilitate running.
 Wear protective clothing and rubber gloves during operation, maintenance,
service or repair. Wash hands with disinfectant after work.
 Do not contact the waste and its components with free hands.
 Instrument uses blood as samples. Blood may contains microbial
pathogens which can cause infection easily. Therefore, operation must be
done carefully, if necessary, wear protective gloves to prevent the operator
himself and people around being infected by pathogenic microorganisms.
Even the control and calibrator can be infectious, we should wear
protective clothing and rubber gloves during calibration.
2.7 Reagent
 Check marks on the package.

 Avoid direct contacting with reagents, since the reagents may irritate eyes,
skin and mucous membranes.
 If skin contacts with the reagent, rinse it with plenty of water immediately.
 If eye contacts with the reagent, rinse it with plenty of water and seek
medical advice immediately.
 Establish a set of emergency measures in laboratory is very necessary.
 Protect the reagents from being polluted by dust, dirt and germs.
 Reagents must be used within the validity period.
 Handle the reagents properly to prevent bubble. Do not shake! The
reagent can not be used immediately after transport.
8
 Do not let the reagents spilt. If it happens, wipe away with a cloth.
 If you swallow reagents accidentally, please seek the medical attention
immediately.
 Diluent is a kind of good conductor, if being spilt next to the wire or device,
it may cause electric shock. Please turn off the power, unplug the plug and
clean the diluent.
 The probe cleaning solution or detergent is strongly alkaline cleaner. Do
not let it contact the skin or clothes. If that happens, rinse the skin and
clothes with plenty of water immediately.
 Probe cleaning solution contains sodium hypochlorite. If it contacts the
instrument surface, wipe up with a cloth immediately, otherwise it will
corrode the surface.
 Ensure that the reagents keep the same level with the instrument or lower.
Do not put reagents on the top of the instrument.
2.8 Maintenance
 As a precision electro-optical instrument, maintenance is necessary for

normal operation. The test data may have small deviations without regular
cleaning. In rare cases, operator might being infected due to poor cleaning.
 To prevent infection, electric shock and burn, operator must wear rubber
gloves in maintenance work. Wash hands with disinfectant after work.
 Use special tools for maintenance.
 All the cleaning and maintenance procedures must be in accordance with
the manual operation.
 Do the daily, weekly, monthly maintenance in accordance with the manual
operation.
 If the instrument is not used for a long time, empty the rinsing flow
according to the procedure before disuse. Ensure the instrument is in a
good working condition before reuse.
 reinstallation can only be done when replacing standby parts.
2.9 Laser
CAUTION: The instrument uses He-Ne laser, the laser is protected by a shield.
If remove the shield, the laser may burn eyes and cause harmful radiation.
9
Only the service technician assigned by URIT can open the lid.
2.10 Consumables
The disposal of residual reagents, cleaning agent and all waste must comply
with local laws and regulations. Used samples and reagents should be
separated from ordinary waste, or they may cause environmental pollution.
Pollutants may also make the equipment unable to work.
2.11 Security Sign
Be ware of electric shock
Protect from heat and radioactive

sources
Equipotentiality
Alternating current
In vitro diagnostic medical device
Lot number
Serial number
Use by
Metering License
10
Production Date
Manufacturer
2.12 Operators
 This medical instrument must be operated by well-trained personnel

exclusively. If being operated incorrectly by non-skilled staff,
misemployment will lead to inaccurate measurement and cause
misdiagnosing, delaying patient’s treatment or doing harm to the operator
himself, even damaging the instrument.
 Falling to operate in accordance with instruction will lead to incorrect
operation, such as test parameter setting error. It may damage the
instrument and result in wrong diagnosis results.
 Maintenance should be carried out by professional technicians. It will
cause test errors result from unauthorized technicians and nonstandard
maintenance.
 Invalid hardware / software will affect the accuracy of test results. The
operator needs to contact the after-sale service personnel as soon as
possible.
11
2.13 Computer Virus
CAUTION
Although our software has been checked to make sure there is no computer
virus, some measures must be considered in the daily operation. Here are
some checking procedures, but not completed. Depending on your working
conditions to choose appropriate measures:
1. Use a virus checker program for regularly checking.
2. Do not install other application program except virus checker program.
3. Do not open unknown email attachments.
4. Do not download any file which has nothing to do with the software program.
5. Check files in the folder for anti-virus.
6. Do not use U disk or other storage media on the computer to prevent
bringing virus to the computer.
12
Chapter 3 System and Function
3.1 Overview
URIT-5500 Five-Part-Diff Auto Hematology Analyzer is an vitro diagnostic

medical device. It is used for blood cell count, WBC five part differential and
hemoglobin concentration measurement in clinical tests. This instrument can
provide the accurate test data of human venous blood, which provide the
necessary reference for clinical diagnosis.
The instrument provides a fast count, all operations (including sampling,
measurement and results output) are fully automated. You only need to put the
whole blood samples on the test tube rack. The instrument will automatically
start counting when detecting the samples. About 30 seconds,
three-dimensional graphics data and results can be displayed in the LCD
screen. The results can be printed or transmitted to the LIS system.
The biggest feature of the instrument is that it can automatically sampling and
rinse the residual blood on the sample aspiration probe, which can avoid
operators contacting the samples directly to ensure the security.
3.2 Parameter
NOTE
 The instrument is suitable for screening instrument clinically, the operator
should integrate medical cases to review results to do the clinical
judgments, if necessary, microscopy for specimens should be done.
 The physicians need the subsidiary information of patients which includes
age, sex, genetic factors for further examination.
The instrument can analyze and arrange the samples data automatically and
shows the blood cell and white blood cell 5 part differential count respectively.
13
System and Function
Also, it will give the three-dimensional plot and scatter diagram of white blood
cells and histogram of red blood cells and platelet.
The URIT-5500 generates the following 34 test parameters in table
3-1(including two histograms, two three-dimensional plots and two scatter
diagrams).
Figure3-1 Parameters
Abbreviation Full Name Unit
WBC White Blood Cell Count 109cells/L
LYM% Lymphocyte Percent %
MON% Monocyte Percent %
NEU% Neutrophile Percent %
EOS% Eosinophile Percent %
BAS% Basophil Percent %
LYM# Lymphocyte Count 109cells/L
MON# Monocyte Count 109cells/L
NEU# Neutrophile Granulocyte Count 109cells/L
EOS# Eosinophile Granulocyte Count 109cells/L
BAS# Basophil Granulocyte Count 109cells/L
RBC Red Blood Cell Count 1012cells/L
HGB Hemoglobin g/L
HCT Hematocrit (relative volume of erythrocytes) %
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
MCHC Mean Corpuscular Hemoglobin Concentration g/L
RDW_CV Red Blood Cell Distribution Width repeat %
precision
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 109cells/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL
PCT Plateletcrit %
P_LCC Large Platelet Count 109cells/L
P_LCR Large Platelet Percent %
RETIC Reticulocyte %
RETIC_ABS Reticulocyte absolute number 109/ul
IIRF Immature Reticulocyte Fraction %
Remark: PCT and PDW are the inferred parameters. They are provided for
laboratory use only.
14
System and Function
3.3 Structure
CAUTION
 The instrument needs several people work together to move since it is

relatively large. Please use proper tools and follow relevant safety code
when moving.
 Take out the instrument and then check whether the appearance is intact.
Ensure there is no damage during transport.
The analyzer is consisted of host, computer and an external printer (optional).
1
2
Figure 3-1A Front View

1---Standby Status Indicator 2---Working Status Indicator
3---Fault Status Indicator
15
3
1
4
Figure 3-1B Front View (Remove the front cover)
1---WBC/HGB Counting Chamber 2----LMS Counting Board

3----RBC Counting Chamber 4---- Peristaltic Pump
5--- Sample Aspiration Probe
16
2
8 10
9
Figure 3-2 A Left Side View
1--- Left Side Door Holder 2--- Detergent Reservoir

3--- Diluent Container 4--- Sheath Container
5--- Sheath Flow Connector 6---- Diluent Flow Connector
7--- Waste Flow Connector 8---Lyse Flow Connector
9---Detergent Flow Connector 10---- Waste Sensor Connector
17
Figure 3-2 B Left Side view (Remove the left side door)
18
1
Figure 3-3 A Right Side view 2
1--- Right Side Door Holder 2--- Power Switch
19
Figure 3-3 B Right Side View (Remove the right side door)
20
5
2
1 3
4
6
Figure 3-4 Rear View
1--- Grounding Terminal 2---- COM Port

3--- Power Receptacle 4--- Power Input Stopwatch
5--- Cooling Fan 6---- USB Port
21
Figure 3-5 Vertical View（Optical Bench）
 The He-Ne laser is above the instrument. Do not open the upper cover for
your safety, only the personnel authorized by UNIT can open it.
22
System and Function
3.4 Counting Operation Screen
After startup, the instrument will enter into the count screen automatically.
Figure 3-6 Counting Interface
This interface can be divided into the following areas by functions:

1. Main Menu Area
By clicking the button, operator can enter into corresponding interface to achieve
the functions. Please refer to the following table to select the appropriate button.
23
System and Function
Table 3-2 Main Menu Button

Button Function
Data Query the test results
QC Run quality control operation
Setup Set system parameters
Maintenance Replacement of reagents, maintenance of equipment
Service Maintain and test the equipment
Limitation Limitation setting
Help Operation help
Exit Turn off the equipment
2. Data Edit Area

Display name, age, sex, blood type and other details of samples. The operator
can switch input methods to input sample information by pressing "Ctrl + Shift".
3. Shortcut Key Area
Table 3-2 Shortcut Key Button
Shortcut Key Function
Run Do the background test
Clean Pour the diluent, detergent, sheath and lyse into
relevant tubes
Flush Special flush procedure
Transfer Transmit the test data to other computer systems
manually, such as the LIS system
Print Print the test result
3D View the three-dimensional map of WBC differential.
Today Display today’s data
Input Sampling automatically and input the data
Reticulocyte Reticulocyte test interface
4. System Time
Display current date and time.
5. Counting Results Display Area
Display test results, parameter units, reference range, alarms, scatter plot, 3D
map and other results information.
3.5 Reagent, Control and Calibrator
The reagent is configured specifically for the URIT-5500 flow systems in order to
provide optimal system performance.Each URIT-5500 is checked at the factory
using the specified reagents and all performance claims were generated using
these reagents. Thus non-URIT reagents will lead to defects in the performance
24
System and Function
of the analyzer and serious mistakes, even accidents.

NOTE
 Reagents must be stored at room temperature to ensure optimal
performance. All reagents should be protected from direct sunlight,
undercooling and overheating during storage.
 The background test should be done after the replacement of diluent, lyse,
sheath and detergent to ensure it is within the normal range.
 The reagent inlet tubes have a cap attached that minimizes evaporation and
contamination during use. The pipe can only insert reagent through the cap.
Please close the cap tightly.
 Ensure all reagents to be used in validity period.
3.5.1Diluent
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) Clean WBC and RBC micro-aperture and tubes.
(4) Provide a conductive environment for counting
Storage and service life after opening: Keep the diluent under 5-35 ℃, after
opened, it can be used to the validity period on the label. Once opened
(connected to the instrument), the product shelf life is only 60 days.
3.5.2 Sheath
Sheath is used to keep the original ecology of blood cells and bleach RBC to
eliminate the scattering of laser. WBC maintains the closest cell structure to its
original state. Basophil structure occurs minor changes for the water-soluble
property of basophilic granule. RBC osmotic pressure is higher than sheath, so
RBC is changed by sheath. The hemoglobin of RBC diffuses from the cells, and
moisture content of sheath diffuses into cells. Although the cell membrane
remains good, but the RBC and sheath have the same refractive index, and it
showed under the laser virtually.
Storage and service life after opening: Keep the sheath under 5-35 ℃, after
25
System and Function
3.5.3 Lyse
Lyse is a new reagent without azide and cyanide and meets the requirements as
follows:
(1) Dissolve RBC instantly with minimum ground substance complex.
(2) Transform the membrane of the WBC to diffuse the cytoplasm. At the same
time, the membrane will shrink centre on 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 the serious pollution to human body and environment that caused by
cyanide.
Storage and service life after opening: Keep the lyse under 5-35 ℃, after
3.5.4 Detergent
Detergent contains the active enzyme to clean the agglomerated protein in the
WBC, RBC probes and measurement circuit.
Storage and service life after opening: Please store it in a cool dry place under
5-35℃. Away from direct sunlight, or ingredients of detergent will be invalid as
the exposure time goes on. Once opened (connected to the instrument), the
product shelf life is only 60 days.
3.5.5 Probe Detergent
Probe detergent contains effective oxide to clean the stubbornly-blocked

apertures on the WBC, RBC probes.
CAUTION
 Detergent and probe detergent is alkali cleaning agent

(1) Prevent skin and eyes from contacting the reagent.
(2) Once contact with skin, rinse with water.
(3) Once contact with eyes, rinse with water and seek medical treatment
immediately.
26
System and Function
(4) If ingested, induce vomiting and seek medical treatment immediately.
3.5.6 Control and Calibrator
Control and calibrator are for quality testing and calibration.

Control is an industrial production of whole blood. It is a hematology reference
control used in monitoring determinations of blood cell values on hematology
analyzers. It is with low, normal and high value. Three controls must be run
every day to ensure the reliability of the results. Calibrator is also an industrial
production of whole blood. It is used for calibration. Please refer to the
instruction of control and calibrator for use and storage methods.
The "control" and "calibrator" mentioned in this manual refer to the special
control and calibrator assigned by URIT. Users can purchase from URIT or
agents designated by URIT.
27
Chapter 4 Installation
4.1 Overview
CAUTION
 Environment Requirements: Temperature: 15 ℃ ~ 35 ℃ ; Relative

humidity: ≤ 85%;
 Place the instrument on a smooth and big enough platform which is easy
to operate. Away from direct sunlight.
 Try to use a separate AC receptacle, and install stabilized voltage supply or
UPS. Do not share an AC receptacle with centrifuges, room temperature
shower (thermostat), refrigerators, air conditioners or ultrasonic cleaning
equipment or other equipment which will interfere the instrument
CAUTION
Installation of the analyzer by an unauthorized or untrained person could result

in personal injury which is exclusive of the warranty. Never attempt to install
and operate the analyzer without a URIT authorized representative.
This instrument has been tested strictly before delivery. It should be carefully
packed before transport in order to avoid being hit. Check the package
carefully to see whether there is a physical damage when arrive. If damaged,
please immediately contact the after-sale service department of URIT or local
agent.
4.2 Unpacking and Inspection
Take out the analyzer and accessories from shipping carton carefully, keep the
packing material for further transport or storage. Check as 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 URIT Customer Support Center if any problem occurs.
28
Installation
4.3 Space Requirements
In order to ensure the proper space for operation, maintenance and

replacement of reagents, the host installation needs to meet the following
requirements:
(1) Choose a place near the power supply.
(2) Eight inches of space behind the analyzer must be left for air flow.
(3) There should be 100 cm of space above to either side of the analyzer for
service access.
(4) Sufficient space is required beneath for reagents, waste containers.
4.4 Power Supply Requirements
Be sure that the system is located at the desired site before attempting any
connections. See Table 4-1 for details.
Table 4-1 Power Supply Requirement
Optimal Voltage Voltage Range Frequency
AC220V AC220V±22V 50/60 Hz
WARNING:
 Analyzer should be used in the condition of well ground connection for
ensuring accuracy of instrument and safety of operator.
 A fluctuated voltage would impair performance and reliability of the
analyzer. Proper action such as the installation of E.C manostat (not
provided by URIT) should be taken before operation.
 Frequent power failure will seriously decrease the performance and
reliability of the analyzer. Proper action such as the installation of UPS (not
provided by URIT) should be taken before operation.
4.5 Environment Requirements
(1) Temperature: 15～35℃(Optimum temperature is 25 ℃)

(2) Relative humidity: ≤ 85%
(3) Recommend to install heating and cooling air conditioning
(4) Avoid using the instrument at extremely high or low temperature.
(5) Away from direct sunlight.
(6) Choose a well-ventilated place.
(7) Away from communication equipment which may interfere the instrument
by producing altofrequency electric wave.
29
Installation
WARNING:
The instrument takes full account of the electromagnetic compatibility
problems. The electromagnetic interference generated by instrument will not
disturb itself and devices nearby. If the test result has a large deviation, please
check whether the instrument is being placed near a electromagnetic field or a
short wave radioactive source (radar, X ray, centrifuge, scanner, cell phone
etc.).
4.6 Waste Requirements
WARNING:
To prevent environmental pollution, the waste is prohibited to pour into the
sewer directly. The waste must be processed by biological or chemical
methods before pouring into the sewer. Hospitals and laboratories have the
obligation to comply with the relevant provisions of environmental protection
department of local government.
For every 20L waste, it is recommended to add the following chemicals into
waste containers:
(1) 50ml of sodium hydroxide solution (200g / L) to prevent gas forming.
(2) 250ml of sodium hypochlorite solution (12% chlorine) to handle the waste
biological risk.
4.7 System Installation
4.7.1 Computer Installation
CAUTION
Please ensure that the computer equipped is only for controlling the operation.
If install other software, use removable storage devices such as U disk, or play
games, surf the Internet on the computer, etc., it will easily being infected by
virus and cause system damage or other errors.
30
Installation
4.7.2 Tubing Installation
There are five tube-connectors on the left panel: LYSE, DILUENT,

DETERGENT, SHEATH and WASTE, each of which is wrapped with a cap to
avoid contamination by the URIT before shipment. Uncover and set the caps
aside carefully for further use on initial installation.
NOTE
 After installation, all tubes should be in a nature relaxed state and without
distortion.
 Using tools for tubing installation is prohibitive. Only installing by hand is
allowed.
 The reagent bottle can not be used if there is damage, leakage, expiration
and other anomalies. Please contact with local suppliers or after-sale
service department of URIT directly.
 To ensure safety and take optimal system performance into account,
manufacturers recommend that all reagents should be placed on the same
base or lower position.
1. LYSE Tubing Installation

Remove the lyse tube with red faucet from reagent kit and attach it to LYSE
connector on the left panel, place the other end into the lyse container. Twist
the cap until secure.
2. DILUENT Tubing Installation

Remove the diluent tube with blue faucet from reagent kit and attach it to
DILUENT connector on the left panel. Place the other end into the diluent
container. Twist the cap until secure.
3. DETERGENT Tubing Installation

Remove the detergent tube with yellow faucet from reagent kit and attach it to
DETERGENT connector on the left panel. Place the other end into the
detergent container. Twist the cap until secure.
4. SHEATH Tubing Installation

Remove the sheath tube with black faucet from reagent kit and attach it to
SHEATH connector on the left panel. Place the other end into the sheath
container. Twist the cap until secure.
5. WASTE Tubing Installation

Remove the waste tube with black faucet from reagent kit and attach it to
WASTE connector on the left panel, connect BNC plug with the socket marked
“SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the waste
31
Installation
container until secure. Place the container on the level at least 50cm lower
than the analyzer.
4.7.3 Printer Installation
Following these steps to install the printer:

1. Place the printer in an appropriate location adjacent to the instrument so as
to operate easily;
2. Take out the printer from transport package.
3. Check the printer, if being damaged, please contact supplier;
4. Check the printer power;
5. Assembly the printer according to printer manual;
6.Connect the power cord to the printer, and then insert the wire into the
grounding plug;
7. Confirm that the printer and computer are properly connected;
8. Install the ink cartridges and paper according to the instructions; ensure
the printer is adjusted to the correct receiver size;
9. Connect the power cord to a grounded outlet and turn the power on.
4.8Transport and Storage Requirement
When the instrument is without using for a long time or before transportation,
please run the "Prepare Shipping" procedure. please refer to Chapter 11
"Maintenance" for details. Proceed as follows:
1. Select "Non-use Packing" on the "Maintenance" interface;

2. Follow the prompts to unplug the relevant tubing connectors and keep the
waste interface;
3. Instrument starts emptying operation, and the progress bar is on the bottom
of the screen.
4. After emptying, back to maintenance interface.
NOTE
 Storage temperature: -20 ℃ ~ 55 ℃;.
 Relative Humidity: ≤ 95%;.
 Atmospheric pressure: 50kPa-106kPa
 Before delivery, external disinfection is needed.
32
Chapter 5 Principles of Operation
5.1 Overview
URIT-5500 uses electrical impedance method (also known as Coulter principle)

to detect the amount and volume distribution of white blood cells, red blood
cells and platelets. The colorimetric method is for determining the content of
hemoglobin. The 4-angle laser scattered method is for the five part differential
of white blood cells. Three separated channels are used for getting the blood
cells counting results respectively.
(1) WBC and five part differential data are detected with laser in WOC flow cell.
(2) WBC and HGB are detected by electrical impedance and colorimetric
methods in WBC counting chamber.
(3) The data of RBC and PLT are detected by electrical impedance methods in
RBC counting chamber.
In each counting process, the instrument will aspirate, dilute and mix the
samples and then test each parameter.
5.2 Sample Aspiration
URIT-5500 supports two modes of cell blood counting analysis, these two
models are closed sampling.
(1) Whole blood automated (batch) sampling mode;
(2) Whole blood single (emergency) sampling mode.
The aspiration volumes are:

Whole blood automated (batch) sampling mode 160 µL±5％
Whole blood single (emergency) sampling mode 160 µL±5％
The whole blood sample is aspirated into the analyzer by the aspiration
peristaltic pump and distributed into different test channels by shear valve.
5.3 Sample Dilution
The sample is divided into trisection after being aspirated. These triplet
samples will inflood into the WBC counting chamber, RBC counting chamber
and sheath pre-mixing cup respectively and then react with different reagents
to get the results of white blood cell counting / hemoglobin measurement, red
blood cell / platelet counting and WBC five differential.
According to the different needs of the operators, the instrument provides two
33
Principles of Operation
operating modes: whole blood automated (batch) sampling mode and whole
blood single (emergency) sampling mode.
5.3.1 Whole Blood Automated (Batch) Sampling Mode
1. WBC / HGB Dilution Process
Whole Blood Sample 20ul
Add 8ml Diluent
Add 1ml Lyse
Dilution ratio is 1:400
2. RBC / PLT Dilution Process

Whole Blood Sample 0.64ul
Add 8ml Diluent
34
3. WBC Differential Dilution Process
Whole Blood Sample 28ul
Add 1.5ml Sheath
5.3.2 Whole Blood Single (Emergency) Sampling Mode.
The counting process is the same as whole blood automated sampling mode.
It mainly used for inserting emergency test during the batch test process
35
5.4 WBC Test Principle
5.4.1Four-Angle Laser Light Scatter Technology
Figure 5-1 WOC Flow Cell
The whole blood samples are diluted with an appropriate proportion with
sheath; white blood cell remains its original state approximately. Using flow
cytometry to make the cells in a single arrangement. The scattering density
can be tested through the laser beam detection zone.
(1) 00: Forward angle light scatter (10～30), which can be used to measure cell
size;
(2) 100: Narrow-Angle Light Scatter (700 ～ 1100), which can be used to
measure cell complexity and structure.
(3) 900D: Ninety-degree depolarized light scatter (7000～11000), which can be
used to isolate the eosinophil from neutrophile.
(4) 900: Vertical light scattering (700～1100), which is mainly used to measure
the inside particles and components of the cells.
36
Figure 5-2 Multi-Angle Laser Scatter Optical Bench

Light source is a vertical direction He-Ne laser with wavelength of 632.8nm
and frequency of 5nw. Laser beam goes through a cylindrical lens which can
change the shape of beam spot from circle to oval. Then the beam goes
through a 125um cutting slice which can prevent low light passing and forming
a homogeneous diffraction fringe. Finally, it is shaped into a spot with a
diameter of 80um through an imaging lens and focus on the cell in the quartz
sheath flow pool.
The laser beam is small in the horizontal direction, so the cells do not scatter
laser much. If the remaining horizontal light reaches the 0° detector, light
diaphragm can block it to prevent electronics saturation. The horizontal
forward angle light directly scatter to the punch hole through the convergent
lens. The light of 0 degree pass through the hole to the silicon photodiode
detective unit of 0 degree.10 degrees scattering light reaches to the 10
degrees silicon photodiode detection unit by reflector.
Vertical scattered light is collected by the condenser lens group, and then go
through a 700um cutting opening (filter stray light and improve accuracy). After
the scattered light which contains cell information passing through the
condenser lens group, the vertical scattered light will be divided into two parts
by a beam splitter mirror. A part of light directly scatters to the 90 degrees
photomultiplier tube. The remaining scattered light will go through the line
polarizer, and only the depolarizing scattered light can reach 90 degrees
depolarizing photomultiplier tube.
37
Figure 5-2 Optical Detection System
1— System Work Platform 2— Laser Bracket

3— Laser Plate 4— HE-NE Laser
5— Reflector Plate 6— Support Copper Cylinder
7— Cylindrical Mirror Bracket 8— 125 Microns Slit and Bracket
9— Imaging Lens Group and Bracket
10—WOC Flow Cell Fine-tuning Mechanism
11—WOC Flow Cell
12—Side Condenser Group and Fine-tuning Mechanism
13—Forward Condenser Group and Bracket
14—700 Microns Slit and Bracket
15—Spectroscope and polarizer Bracket
16—PMT Shield
17—PMT
18—PMT Position Adjusting Mechanism
38
Figure 5-3 Scatter Plot Principle
The gray area on left scatter plot is the ghost cells. It reflects that RBC dissolve
into pieces on the scatter plot; green is for lymphocyte group; pink is for
monocyte group; blue is for neutrophil; white is for basophil group; red is for
eosinophil group.
Figure 5-4 Three-dimensional Plot
Figure 5-4 is a three-dimensional plot of WBC (3D). It can be magnified to view

WBC differential and change S0, S10, S90 relative positions according to
clinical experience.
5.4.2 White Blood Cell Differential
URIT-5500 does the four-angle scatter analysis for the cells which go through
the WOC flow cell. White blood cells are being divided into 5 parts: basophil,
eosinophil, monocyte, neutrophil and lymphocyte. The default unit of cells
number is 109/L.
 White Blood Cell Number

Get the value of WOC and WIC simultaneously by laser and electrical
impedance methods and finally get the total number of white blood cells
through the system.
39
 Lymphocyte Number (Lym#)

 Lymphocyte Percent
Lym% = Lym#/WBC
 Monocyte Number (Mon#)
 Monocyte Percent
Mon% = Mon# /WBC
 Neutrophil Number (Neu#)
 Neutrophil Percent
Neu%=Neu#/WBC
 Eosinophil Number (Eos#)
 Eosinophil Percent
Eos%=Eos#/WBC
 Basophil Number( Bas#)
 Basophil Percent
Bas%=Bas#/WBC
5.5 Hemoglobin Concentration Test Principle
5.5.1 Colorimetry Principle
Add lyse into the diluted sample in WBC counting chamber. Red blood cells
will dissolve and release hemoglobin. Then the hemoglobin combines with lyse
to form hemoglobin mixture. Use LED light-emitting diode to illuminate the
hemoglobin mixture by the monochromatic light of 540nm wavelength at one
end of the WBC counting chamber. At the other end, using optical tube to
receive the transmitted light and then amplify the light intensity signal to
voltage signal. Compare it with the voltage generated by the transmission light
intensity before adding the sample into the colorimetry chamber (only with
diluent) to get the value of hemoglobin concentration. Hemoglobin
concentration is proportional to the absorbance of samples of 540nm
wavelength. The process of measurement and calculation is done
automatically by the analyzer, and the results will be displayed in the analysis
results area.
40
5.5.2 HGB Parameter
Hemoglobin concentration (HGB) is calculated by the following formula:

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.
5.6 Red Blood Cell /Platelet Test Principle
5.6.1 Electrical Impedance Principle
The analyzer uses the traditional electrical impedance for the blood cells
testing and counting. See Figure 5-5, conductive liquid (mainly diluent)
provides constant current source for electrode to help the circuit form a stable
impedance loop. When the cell pass through the pores, the conductive liquid is
substituted by cells, and the resistance of loop changes to produce electrical
pulses. When different volumes of cells pass through the pore, there will have
different electrical pulses amplitude. So that we can determine the number and
size of cells according to the number and amplitude of electrical pulses.
Figure 5-5 Electrical Impedance
41
As the number of pulses corresponds to the number of cells pass through the
pores, the pulse amplitude corresponds to the volume of the cells, so the
analyzer can count and classify the cells according to size of the cells. The
analyzer automatically divides the cells into red blood cells, white blood cells,
platelets and other groups in accordance with pre-set volume classification
procedure.
5.6.2 Volumetric Metering
Figure 5-6 Volumetric Metering

The analyzer controls the quantity of samples that pass through the pore
during counting by volumetric metering unit to obtain the exact counting results
of blood cells in quantitative samples. The volumetric metering unit includes
volumetric metering tube and two photodetectors. As shown in Figure 5-6,
empty the volumetric metering tube before counting. When the sample flows
through the pore, the liquid level of volumetric metering tube will decline slowly.
When the liquid level passes through the start detector, it will produce an
electrical signal and then the analyzer starts counting; when the liquid level
reaches the stop detector, it also will generate an electrical signal and then
finish counting. If there are bubbles or other abnormal flowage in the flow
system during the process, "bubble" or "clog" alarm will be shown. Please refer
to chapter 11 Troubleshooting for handling.
42
5.6.3 Red Blood Cell Parameters
 RBC Number
The instrument gets the number of red blood cell count (RBC) by measuring
the corresponding electrical pulse numbers of RBC directly. The unit is 1012/L.
RBC = n ×1012 / L
 MCV
The mean corpuscular volume (MCV) is the average volume of individual red
blood cells. The MCV is derived from the RBC size distribution data. The unit is
fL.
 HCT
The hematocrit (HCT) is the ratio of red blood cells to plasma. It is expressed
as a percentage of the whole blood volume. The HCT is calculated from the
RBC count and the MCV as follows:
 MCH
The mean corpuscular hemoglobin (MCH) is the average amount of
hemoglobin in the red blood cell and being expressed in picograms. The MCH
is calculated from the RBC and the HGB as follows:
 MCHC
The mean corpuscular hemoglobin concentration (MCHC) is the ratio of the
weight of hemoglobin to the volume of the average red blood cell. It is
expressed in percent and calculated from the HGB and the HCT as follows:
 RDW-CV
The RDW-CV is derived from the RBC histogram and being expressed in
percent.
 RDW-SD
The RDW-SD is the width of 20% peak value of red blood cell distribution
43
histogram .The unit is fL.
 RDW
The RDW is derived from the RBC histogram. It is the volume distribution
geometric standard deviation of RBC.
5.6.4 Platelet Parameters
 PLT Number
The instrument gets the number of platelet (PLT) by measuring the
corresponding electrical pulses of RBC directly. The unit is 109/L.
PLT = n ×109 / L
 MPV
The mean platelet volume (MPV) is derived from the PLT histogram after the
PLT count has been determined. The unit is fL.
 PDW
The platelet distribution width (PDW) is a measure of the heterogeneity of the
PLT population. It is expressed as the geometric standard deviation(10 GSD).
 PCT
The PLT is calculated as follows:
Remark: The unit of PLT is 109/L. The unit of MPV is fL
44
Chapter 6 Settings
6.1 Overview
Initialization setting of URIT-5500 has been done before delivery. Setting of the
interface at the first boot is default. To meet the different needs, some
parameters can be re-set.
6.2 Time Setting
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. If time
setting is changed, the time on screen and printed output will also change.
1. Entering into Setting
Click "Time" button on the "Setup" interface , and then enter into the interface
as Figure 6-1.
Figure 6-1 Time Setting
45
Settings
2. Select Format
There are three formats of date: YYYY-MM-DD, MM-DD-YYYY, and
DD-MM-YYYY. Click the button to select the format needed.
3. Modification
Determine the correct date and time, then direct input "year / month / day, hour
/ minute / second".
4. Save and Exit
Modify the date and time, then click the "OK" bottom in the right corner of the
interface shown in Figure 6-2. Click “Yes" to save the results; click "No" to exit.
6.3 System Maintenance
Cleaning time, sleep status and counting time can be set in the interface
shown in Figure 6-3.
Figure 6-3 System Setting

46
Settings
1. Auto Clean Setting

Enter into the "Setup" interface, and then click "System Maintenance", select
"Times" in "Auto Clean”. It is recommended that the flow system should be
cleaned once for each one hundred counting. See Figure 6-4.
Figure 6-4 Auto Clean Setting
2. Auto Sleep Setting

Enter into the "Setup" interface, and then click "System Maintenance", select
"Times" in "Auto Sleep”. It is recommended to set the time according to the
frequency in order to save energy. See Figure 6-5:
47
Settings
Figure 6-5 Auto Sleep Setting

3. Auto Blank Setting
Enter into the "Setup" interface and then click "System Maintenance". It is
recommended to select "on" in "Auto Blank” so that after each boot, the
instrument can automatically enter into counting interface and run background
tests to check whether the instrument is normal.
48
Settings
Figure 6-6 Auto Blank Setting
4. Counting Time Setting

Enter into the "Setup" interface and then click "System Maintenance”. Set the
upper and lower limits of WBC and RBC counting time warning as shown in
Figure 6-7.The upper limit of WBC is 14 seconds. If the counting time is more
than this value, "Clog" will be alarmed. The lower limit of WBC is 9 seconds. If
the counting time is more than this value, "Bubble" will be alarmed. The upper
and lower limits of RBC are similar to those of WBC.
Note: The upper and lower limits are set before delivery. Generally, they should
not be modified so as to avoid false alarm.
49
Settings
Figure 6-7 Counting Time Setting
6.4 Dictionary Maintenance
If the name of the same department or doctor needs to be inputted repeatedly

in the "Counting" and "Query" interface, the operator can set up a simple code.
When editing patient’s information, the operator only needs to input the code
and press "Enter" button, then the corresponding department or doctor’s name
will be displayed.
1. Entering into Dictionary Maintenance

Enter into "Setup" interface and click "Dictionary Maintenance", then the
default interface will be displayed as Figure 6-8.
2. Department Code Setting
Click "Add", input the name of department in name box, such as "internal
medicine" and then input “1" in code column. If the operator wants to input
"internal medicine" next time, he only needs to input "1" then press "Enter".
Click "Del" button to delete the code item established.
Click "Mod" button to modify the code item established.
50
Settings
Figure6-8 Department Setting
3. Doctor Code Setting

Click "Doctor" menu. Operator can establish a relationship between the code
and doctors' name to save input time.
Click "Add", input doctor's name in name box, such as "LiQiang" and “002" in
code column. Once the operator wants to input "LiQiang" next time, he only
needs to input "002" then press "Enter". See Figure 6-9.
Click "Del" button to delete the code item established.
Click "Mod" button to modify the code item established.
51
Settings
Figure 6-9 Doctor Setting
6.5 Barcode Information
The user can select the encoded mode of built-in barcode scanner supported
by the analyzer in "Bar Code Info" interface. See Figure 6-10.
52
Settings
Figure 6-10 Bar Code Information Setting
6.6 Sampler
Function of auto sampling can be set in "Sampler" interface. The analyzer can
stop sample counting by selecting "Auto Sampler Pause Condition" if there is
something wrong with the instrument.
The sample numbering rule in the mode of auto sampling can be set in the
interface “Vacant test tube rack, next sample NO.”. If choose "Keep", even the
analyzer find a vacancy in the test tube rack, the sample number of the next
one will not change; If choose "Auto-increment", the next sample number will
be added "1".
In "Scan Mode of Auto-sampler" interface, if select "Auto Scan", the test tubes
number will be scanned by the built-in scanner; if select "No Scan", the test
tubes number will not be scanned.
In "Batch Input Data" interface, if you choose "Read by ID", the data can only
be read when the test tube number scanned is in accordance with input
number; if you select "Read by order", the system will match the patients'
information before batch test according to the data results detected. If you do
not want to input patients' information, please select "Unread". See Figure
6-11.
53
Settings
Figure 6-11 Sampler Setting
6.7 Display Setting
Select the languages of parameters according to the unit of some parameters

which need to be modified.
1. Entering into Display Setting
Click "Display" after entering into "Setting" interface as shown in Figure 6-12.
54
Settings
Figure 6-12 Display Modification Interface
2. Display Modification Setting

The operator can select different parameters units, Chinese and English
parameter language and reference value order etc. Click the "triangle" button
to select the desired display settings, the results on screen and those printed
out will also change.
3. Save and Exit
Click SAVE, the save dialog box will display (see figure 6-13). Select YES to
save the modification of display settings and back to the corresponding
interface, and NO is contrary.
Figure 6-13 Save Dialog Dox
55
Settings
6.8Print Setting
1. Entering into Print Setting

Click “Print” in the Setup interface and enter the Print Setting interface.(see
figure 6-14)
Figure 6-14 Print Setting

2. Setting Print Options
In Print Setting, operator can select printer type, print format, auto print and
input hospital name in “print title”.
3. Save and Exit
save the print settings and back to the corresponding interface, and NO is
contrary.
6.9 Transfer Setting
In Transfer Setting, operator can set the port number, baud rate, data bit, stop
bit and parity bit of the external communication port.
1. Entering into Transfer Setting
Select Transfer in the Setup interface, then enter the Transfer Setting interface
(see figure 6-16)
56
Settings
Figure 6-16 Transfer Setting Interface
2. Modify Transport protocols

Operator can modify the port number, baud rate, data bit, stop bit and parity bit
of the communication port. If the auto-trans is ON, the test results will transmit
from the communication port automatically.
CAUTION
 Transfer setting is already set before delivery. As a rule, there is no need to
reset, or the data transmission will be affected. Necessary modification
should be done under the guidance of URIT engineer.
57
Settings
3. Save and Exit

save the modification of transfer settings and back to the corresponding
interface, and NO is contrary.
Figure 6-17 Save Setting
NOTE
 Click SAVE and select YES to save the settings after modification,
otherwise it will lose.
6.10 Group Parameters
To monitor abnormal test parameters of blood samples, it is essential for the

operator to set normal ranges of the parameters according to laboratorial or
clinical requirement. Information or indication will be given if the test values
exceed the range. The analyzer provides the limit of 24 parameters, 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.
6.10.1 Limit Review
At Limit setting interface, operator can input proper parameter limits or use the
default limits. Default limits are different depending on the patient group. Figure
6-18 depicts the General group limits, and figure 6-19 depicts the User1 group
limits.
58
Settings
Figure 6-18 Limit Setting
Figure 6-19 Limit Setting
59
Settings
6.10.2 Limit Modification
Operate as follows to modify the parameter limit:

1. Click the triangle on the right side of Group to select the group that needs
to be modified.
2. Select the lower or upper limit of parameters need modification. Move the
cursor into edit box, press “Backspace” on the keyboard to delete raw data
and input the new lower or upper limit.
3. Click SAVE, the save dialog box will display (see figure 6-20). Select NO to
cancel and go back to browsing status of parameters Select YES to save
the modification and back to the corresponding interface.
6.11 User Management
Operator should login the system with identity to operate the routine check.
Only the administrator can modify user setting, so message erection of the
operator is necessary.
1. Entering User Management Setting
Click User in the Setup interface, then enter user management interface(see
figure 6-21)
60
Settings
Figure 6-21 User Management
2. Add User
Input the user’s name, select Permission, set password (default password is
null) and click Add to add the new user.(see figure 6-22)
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Settings
Figure 6-22 Add User
3. Modify User
Double click the user to modify the User name, group and password.
4. Delete User
Select and click Del. to delete the user. Then select YES or NO to confirm
whether to delete the user or not.(see figure 6-23)
Figure 6-23 Delete user
6.12 Permission
In order to guarantee the proper use, it is necessary for the administrator to

only give partial permission to operators, such as only allow operators to query
and count data, but can not delete.
Select one permission in the left box, click Add, it will display in the right box
62
Settings
after clicking Add. Click Del. to delete the selected permission in the right
box.(see figure 6-24)
Figure 6-24 Permission Setting
63
Chapter7 Daily Operation
7.1 Overview
This chapter describes the whole procedures of daily operation from startup to
shutoff, and explains the process of different modes of sample analysis in
detail.
Daily Operation Flow Chart as follows:
Preparations
Startup
Quality Control
Specimen Preparation
Data Input
Sample Count
Result Query And Output
Statistic
Shutoff
CAUTION
 The analyzer must be operated by medical inspection professionals or
trained doctors, technicians.
7.2 Preparations
Check the analyzer as the following steps before startup to ensure the system
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Daily Operation
is ready.
1. Check the Waste Container
The waste should be processed properly and cleaned up before startup every
day.
2. Check the Reagents, Tubes and Powers
Ensure diluent, lyse, detergent and sheath meet the test.
Ensure the tubes of reagents and waste connected well and without bending.
Ensure the power plugs of instrument, computer and outlet connection is
reliable.
3. Check the Printer
Ensure printing paper is sufficient and the installation is proper.
Ensure the power is on and the cable has been connected with the analyzer
and the computer properly.
4. Check the Mouse and the Keyboard

Ensure the mouse and the keyboard has been connected with the computer.
CAUTION
All clinical specimens, controls, calibrators and waste with potentially infectious
hazard. The operator should comply with the safe operation provisions in
laboratory and wear personal protective equipment (lab coats, gloves etc.)
when handling these materials.
7.3. Startup
Turn on the power switch on the right panel, then the status indicator on the
front panel will be orange. The analyzer will automatically detect the operation
of the components when self-checking and initialization after loading, and then
rinse the flow system. It takes about 3 minutes before entering the Blood Cell
Count interface (See Figure 7-1) after initialization.
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Daily Operation
Figure 7-1 Blood Cell Count
After startup, background counting should be performed before blood sample

test. Analyzer can be set to run background counting automatically after
startup. Consult Chapter 6 for the instrument settings.
The range of background is listed in Table 7-1.
Table 7-1 Range of background

Parameter Acceptable range
WBC ≤0.20x109/L
RBC ≤0.02x1012/L
HGB ≤1g/L
PLT ≤10.0x109/L
If the background result is out of this range, repeat the above procedures until
it is in this range. If the results are still out of this range after repeat five times,
please refer to please refer to 11.4.2 for Troubleshooting for help.
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Daily Operation
7.4 Quality Control
Quality Control should be performed before daily test to ensure accuracy of the
results. Please refer to Chapter 8 Quality Control.
7.5 Collection of Blood Samples
CAUTION
 Considering all the clinical specimens, controls and calibrators etc that
contain human blood or serum as being potentially infectious, wear lab
coats, gloves and safety glasses and follow required laboratory or clinical
procedures when handling these materials.
 Do not directly contact blood samples, controls and calibrators, and follow
required procedures when disposing.
CAUTION
 Blood collection and disposal should be performed according to the local
and national environmental regulations or laboratory’s requirements.
 Ensure the whole procedure of blood collection is clean and
contamination-free. All specimens must be properly collected in tubes
containing the EDTA (EDTA-K2·2H2O) anticoagulant.
 Do not shake the sample tube violently.
 Venous blood can only be stored for 4 hours at room temperature. URIT
recommends the blood sample be kept at the temperature between 2-8℃
for longer storage.
7.5.1 Whole blood collection
Collect whole blood sample through vein-puncture and store it 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 and
ensure mix well.
The following anticoagulants are commonly used in whole blood collection:
1. Heparin:
Lead to cell aggregation and change the cytoplasm’s color of
Romanowsky staining. The concentration of high heparin > 7.5UL/
capillary will lead to increased in HCT and MCV.
2. Sodium citrate:
Since sodium citrate is liquid, it may be diluted to 10/11 of the original in
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Daily Operation
the tube filled with whole blood. This anticoagulant is used for agglutination
when a suspect EDTA causes spurious thrombocytopenia.
3. ACD and CPDA:
Most widely used in cell Concentration (especially platelet concentrates),
usually not used for cell counts.
4. EDTA:
In the salt of EDTA, use EDTA K2（United States and Japan）and EDTA K3
（United States and Europe）,sometimes NA2EDTA. And EDTA K2,
EDTA K3 which recommend by ISCH in1993 are most widely used in the
blood test of the world. But other EDTA salts can also be used. EDTA
could lead to Pseudo-thrombocytopenia through Platelet aggregation.
(Incidence is about 1/800)
5. Fluoride:
Use before EDTA. Without side effects according to the survey
7.5.2 Sample stability
Better to use fresh whole blood. ICSH (International Committee for

Standardization of Hematology) defined fresh blood as: samples processed
within 4 hours after collecting. When whole blood samples are thoroughly
mixed, placed in EDTA-tubes, and tested within 8 hours after collecting, the
accuracy of each parameter will be highest. Test samples within 5 to
20minutes or over 8 hours, the WBC volume distribution will offset.
7.6 Information Input
Click Data in the interface to input the detail information about the sample, and
Urit recommends operator to input the detail information before sample
analysis. (see figure 7-2)
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Daily Operation
Figure7-2 Data Input
Click “Ctrl+Shift” on the keyboard to select Input Method.

Name: Input letters or numbers.
Sex: Select male or female. If not selected, default as blank.
Age: Select Year, Month and Day.
Blood Type: Select A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-.
O Rh+, O Rh-. If not selected, default as blank.
Group: Select Auto, Man, Woman, Child, New-born, General, Custom 1,
Custom 2, Custom3.
If Auto is selected, the reference values are listed as Table 7-2.
Table 7-2 Reference Value

Reference Value Age(Year) Sex
General NO input Blank, M,F
General ≥16 Blank
Man ≥16 M
Woman ≥16 F
Child >1 and ＜16 Blank, M,F
Baby <1 Blank, M,F
ID: The ID number is in range from 00000000 to 99999999. If no ID input, the

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Daily Operation
ID of current sample will be automatically added follow the last one.

Case ID: Input the sample number.
Bed No.: Input bed No. of patient.
Department: Input department name or code of operator.
Checker: Input checker’s name or code.
Sender: Input sender’s name or code.
Assessor: Input assessor’s name or code.
NOTE: The ID number is set to 0 only under Background Count. The blood
sample ID CAN NOT be 0.
CAUTION: Each sample has a corresponding identification number. Do not
confuse.
7.7 Sample Counting
7.7.1 Mode
Click on the main interface, the dialog box as figure 7-3 will be displayed.
Select the mode, then press Yes, that the mode will switch to corresponding
mode. At the same time, the icon on the screen will change. means single
sampling whole blood mode , means single sampling pre-dilution mode,
means multiple sampling whole blood mode.
Figure 7-3 Mode Switch
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Daily Operation
NOTE:
 User can choose CBC if he wants whole blood and pre-dilution modes.
CBC mode is only available for counting and without differentials. The
counting result includes 18 parameters and the diagrams of RBC and PLT.
 “CBC+5Diff+RRBC"--- For counting after dissolving the indissolvable red
blood cells. It is suggested that when RRBC? alarm, switch counting mode
to CBC+5Diff+RRBC, and then run counting again so as to eliminate the
interference of white blood cell coning from the indissolvable red blood
cells. If WBC total number is far less than that of the first counting, it shows
that this specimen contains indissolvable red blood cells
7.7.2 Counting and Analysis
WARNING
The sharp sample needle contains residues of clinical specimens, controls or
calibrators probably have potential infectivity. Do not directly contact the
sample probe.
NOTE
 Do not reuse disposables.
 Ensure the inputted ID number correspond with the sample.
CAUTION
Do not open the front panel after start counting.
7.8 Data Query and Output
After each counting, the results are automatically saved in a database that
could store at least 200,000 results include 34 parameters (2 scatter diagrams,
2 histograms, 2 Three-dimensional plots).Operator could review all of the
results, scatter diagrams and histograms that store in the database through
query and statistic.
7.8.1 Data Query
Click “Data”-“Query” at the main interface, and then enter the

query interface. (See figure 7 -4)
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Daily Operation
Figure 7-4 Data Query
The operator can quickly query the results of specimens according to the query
condition such as date, ID, name, sex, age, blood type etc. (Combined Query
is available).Take ID as an example, to query the results between ID 45 and ID
50, click the box in the left of ID and input 45 to 50, click Query, the needed
results will be displayed. (See Figure 7-5)
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Daily Operation
Figure 7-5 Number Query
7.8.2 Data Selection
Click the result needed, the row of result will be highlighted to identify being
selected. Figure 7-6 is the sample record of number 44.
Figure 7-6 Select Single Result
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Daily Operation
Select single data (such as No.44), click “Data” (or double-click directly), then
the detail information of the datum will be displayed.
Figure 7-7 Query Detail Information
Click All, all data in the Query Interface will be displayed in red to identify being
selected. (See figure 7-8)
Figure 7-8 Select All
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Daily Operation
7.8.3 Data Deletion
After processing plenty of samples, it is necessary to clean up or delete the

mass data stored in the analyzer according to the requirement of the operator.
There are two methods to delete data—D_All and Del. .
NOTE
Be aware that once the data are deleted, they can NOT be recovered. Please
operate with caution.
7.8.4 Precision
Check the precision of each parameter of selected sample result, including

Mean, SD, CV%. The calculation formulas are as follows:
N is the number of samples selected, Xi is the results of i times for the

specified parameters.
Selected the results that need to be calculated CV, click Prec. into the interface
as figure 7-9, and check the precision.
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Daily Operation
Figure7-9 Precision
NOTE
 Calculate the precisions of 3~30 samples results .
 “***”means invalid. If some parameters of selected sample are invalid, the
precision is invalid too.
Click Exit and back to the Query interface.
7.8.5 Trend Graph
Operator could see trend graphs of 6 parameters (WBC、RBC、PLT、HGB、

MCV、RDW-CV)of selected sample.
Choose the sample result, and click Trend Graph into Trend Graph interface.
(see figure 7-10)
Figure 7-10 Trend Graph
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Daily Operation
NOTE
 Check trend graphs of 3~500 sample results.
 “***”means invalid. If some parameters of selected sample are invalid, the
Mean, SD, CV% are invalid too. The lower, target value and upper of left
trend graph are set to the range of reference of the general automatically.
Please refer to Chapter 6 Trend graph setting.
The trend graph instruction as follows:
 Every dot corresponds with a single sample result.
 Abscissa indicates the quantity of the selected samples, ordinate indicates
the parameters results.
 The 3 data on the left side of trend graph correspond with 3 lines, means
lower, target value and upper from bottom to top.
Upper: Mean＋Limit(Average×10%);
Target value: Mean;
Lower: Mean－Limit(Average×10%);
 The 3 data on the right side of trend graph mean:
Mean--Average;
SD--Standard Deviation;
CV%--Coefficient of Variation;
N is the number of samples selected, Xi is the results of i times for the

specified parameters.
7.9 Reticulocyte Analysis
The reticulocyte package software enables the operator of the URIT-5500

system to analyze a whole blood specimen for reticulocytes. The reticulocyte
specimen is prepared by using reticulocyte reagent to produce a diluted,
stained sample.
Press Retc to start reticulocyte analysis. The analysis screen is shown below.
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Daily Operation
Figure 7-11 Reticulocyte Analysis
The prepared specimen run with the reticulocyte package on the URIT-5500
system will measure results as a reticulocyte percentage. The reticulocyte
absolute number is automatically calculated when the RBC value is made
available from the Standard Hematology Data Log or entered by the operator.
The Immature Reticulocyte Fraction (IRF) is calculated from the
Reticulocyte % and displayed below the Reticulocyte absolute number.
7.9.1 Principles of Operation
Reticulocytes are defined by the National Committee for Clinical Laboratory

Standards (NCCLS) as transitional red cells, between nucleated red cells and
the so-called mature erythrocytes. In contrast to mature RBCs, reticulocytes
contain ribosomal RNA. This RNA can be seen with certain supravital, cationic
dyes that simultaneously stain and precipitate the polyanion to form a network
or reticulum. The URIT-5500 system reticulocyte method uses the thiazine dye
New Methylene Blue N. The reticulocyte assay is performed in the WOC
channel of the instrument. Sample preparation is performed manually by
diluting 20 μl of blood into a tube of URIT Reticulocyte Reagent. At room
temperature, staining of reticulum is complete within approximately 15 minutes.
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Daily Operation
The stained sample is aspirated in the Open Mode. After the stained sample is
aspirated, it is diluted approximately 50-fold with Sheath Reagent. Once
diluted with Sheath, the RBCs sphere due to the influence of the nonionic
detergent incorporated into the staining solution. Sphering is necessary to
eliminate optical orientational noise that would otherwise be introduced into the
scatter measurements. The usual lytic action of the Sheath is prevented by
electrolytes contained in the staining solution and the lack of the usual
incubation period used in this channel during WBC analysis. In addition, the
high New Methylene Blue concentration in the staining reagent exerts a
stabilizing effect on RBCs.
During data acquisition, 10 degree and 90 degree scatter are collected for up
to 30,000 events. The 0 degree threshold is set high enough to exclude most
platelets. Histogram data are used to differentiate reticulocytes, mature RBCs,
platelet clumps, and nucleated cells. Reticulocytes have 10 degree scatter that
are similar to the scatter for mature RBCs, but differ from them by exhibiting
greater 90 degree scatter. Reticulocytes are reported in percent. The
instrument will automatically calculate the reticulocyte Absolute value if an
RBC count is entered. The RBC value may be obtained from the Standard
Hematology Data Log, or it may be entered by the operator directly on screen.
Immature reticulocytes contain more RNA and absorb more stain than mature
reticulocytes; therefore, they exhibit greater 90 degree scatter. On the
URIT5500, immature reticulocytes are classified as the population of
reticulocytes that exceed a predetermined scatter threshold. Consequently, it
is possible to determine the Immature Reticulocyte Fraction (IRF) from the
scatter measurements.
The IRF was initially designated as the Reticulocyte Maturation Index (RMI),
and defined by NCCLS H44-A1 as a quantitative expression of the relative
maturation of the reticulocytes in the observed reticulum in New Methylene
blue-stained preparations. However, these quantitative visual measurements
of reticulocyte maturation have been little used due to the subjectivity and
imprecision of the manual analysis. Since automated reticulocyte methods
allow the enumeration of immature reticulocytes as a subfraction of the total
reticulocyte population, the preferred nomenclature is Immature Reticulocyte
Fraction (IRF). The immature reticulocytes are then reported as a fraction (or
percent) of the reticulocytes.
The clinical utility2of the IRF is widely recognized as follows:

 Monitor hemopoietic regeneration after bone marrow transplant,
hemopoietic stem cell transplantation, or intesive chemotherapy
 Monitor bone marrow toxic insults from drugs (for example, AZT)
 Monitor erythropoietin therapy in renal failure, AIDS, infants,
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Daily Operation
myelodysplastic syndromes, and blood donations

 Classify anemia
 Monitor efficacy of anemia therapy (Fe, B12, Folate)
7.9.2 Reticulocyte Sample Preparation
NOTICE
1. Add 20uL blood samples to be tested to reticulocyte dye test tube (3.7mL),
and place it at about 30 ° C ~ 35 ° C for 15 to 30 minutes after mixing.
2. The accuracy of the results will be affected more than 2 hours.
NOTE
Avoid contacting with skin and clothing when using the reticulocyte reagent,
since it contains new methylene blue which will contaminate skin, clothing and
many other surfaces.
7.9.3 Reticulocyte Test
Place the prepared reticulocyte samples into the single sampler, then the
dialog shown in Figure 7-12 will pop up. Operator inputs the serial number and
RBC value, then click Run, that the reticulocyte test begins, as shown in Figure
7-13
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Daily Operation
Figure7-12 Reticulocyte Test Screen
Figure 7-13 Process of Reticulocyte Test
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Daily Operation
7.10 Statistic
On Blood Cell Count Interface, click “Data”→ “Stat.” to enter statistics interface
(See Figure 7-14). Operation procedure is as follows:
Figure 7-14 Statistics
1. In the box of statistic date, click to select Start Date and End Date, then
click OK.(see figure 7-15)
Figure 7-15 Data
2. Select types such as Department and Sender in the Statistics Type box,
and then all items selected will be displayed in the middle list box.
3. Select statistic item (or multi-select), click “Cal”, then the desired data will
be displayed in the right list.
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Daily Operation
4. Click Back to return Blood Cell Count Interface.

5. Click Print to print the statistics.
7.11 Shutoff
Shutoff procedure should be performed after finishing all the tests and before
turning off the power. Clean the counting chambers and related tubes. If
continuously use the analyzer or finishing today’s test, shutoff procedure
should be performed at least once every 24 hours.
The procedure of Shutoff as follows:
1. Click “Exit” on the main interface;
2. Pop-up close confirmation dialog;
3. Check whether the procedure of shutoff is finished, the close dialog box is
shown or not.
4. Turn off the power of the instrument and the computer.
CAUTION
May lead to data loss and abnormal boot If the shutoff procedure is not
performed.
83
Chapter 8 Quality Control
8.1 Overview
It’ probably leads to unreliable results for a long time use. In order to maintain
the analyzer precision and eliminate system errors, it’s necessary to perform
quality control.
It’s better to use low, normal and high controls to perform quality control
everyday or using normal control at least. When using control of new lot,
please combine it with the existing controls for 5 days, twice per day, and the
results should be within the range of parameters of the control instruction.
In the following conditions, perform quality control with controls recommended
by URIT:
 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 abnormal parameter value
CAUTION
 Considering all the clinical specimens, controls and calibrators etc. that
coats, gloves and safety glasses and follow required laboratorial or clinical
84
Quality Control
NOTE
 Ensure to perform the following procedure before using the control
removed from the refrigerator:
1. Leave it for 15 minutes to reach room temperature (18-35°C).
2. Rub the vial for 10 to 15 times;
3. And gently invert the vial 1for 0 to 15 times;
4. Ensure that the contents of vial are completely suspended by
inverting the vial and viewing the bottom. Repeat step 2 and 3 for 8
times, or for 2 minutes, until completely suspended.
8.2 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:
(2) X-R QC
In X-R QC method, X indicates mean value, R indicates range of value. X
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Quality Control
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, it calculates 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 of the samples is being done by
surveying the value of MCV, MCH, and MCHC.
8.3 QC Operation
Click QC in main interface, pop up interface as figure 8-1:
Figure 8-1 QC Mode Select

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Quality Control
System offers four quality control options: L-J QC, X-B QC, X-R QC and X QC.
Select the mode and click to enter corresponding interface.
8.4 L-J QC
In L-J QC, the operator could perform QC with 20 test parameters at most.
Considering the different needs, selecting partial parameters for QC is
available. 3 QC documents of high, normal and low are provided for saving.
8.4.1 L-J QC Edit
In different interfaces, click QC Edit enter corresponding edit interface. In L-J

QC interface, click L-J QC to enter edit interface. Input control lot NO., expiry
data and level, then input desired assay and limit according to the control
instruction.(see figure 8-2)
Figure 8-2 L-J QC Edit
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Quality Control
NOTE
The limit should not be more than 40% of assay, or the limit cannot be saved in
database.
Click OK after editing, the dialog box about whether to save the edit result will
display.(see figure 8-3)
8.4.2 L-J QC Run
In L-J QC interface click QC Run, enter the interface as figure 8-4.
Figure 8-4 L-J QC Run
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Quality Control
8.4.3 L-J QC Graph Analysis
In L-J QC interface click QC Analysis, enter graph analysis interface as figure

8-5:
Figure 8-5 L-J QC Graph Analysis
8.4.4 L-J QC Data Query
In the L-J QC interface, click QC Query, enter data query interface as figure
8-6:
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Quality Control
Figure 8-6 L-J QC Query
8.5 X-B QC
X-B QC is different to others, with which the systems can only edit three
parameters: MCV, MCH, and MCHC. It is a QC without controls and a means
of monitoring instrument like controls, but they can’t substitute each other.
NOTE
 Recommend using X-B QC, when the quantity of samples is more than
100.
 X-B QC is for the use of random sample, not for classification samples.
 Observed the trend of QC result in reference range which made up by
reference, low and high limit.
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Quality Control
8.5.1 X-B QC Edit
Before QC analysis, operator should finish the QC edit as follow:

1. In the main interface, click QC, and then click X-B to enter X-B QC
interface.(see figure 8-7)
Figure 8-7 X-B QC
2. Input the assay and limit of parameters that require for quality control.
3. Input the number of required samples when calculate a dot of X-B QC. The
range of selection is 20 to 200, URIT recommend the number is 20.
4. In the X-B QC interface, click On in the X-B Edit to open the X-B mode.
8.5.2 X-B QC Run
When finish QC edit, click Count to operate quality control. The system will
automatically operate a QC calculation after analyzing, and get a dot that
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Quality Control
correspond with each reference of X-B QC and save it in X-B QC graph and
X-B QC list.
8.5.3 X-B QC Graph Analysis
Operator can review QC results of three parameters through graphs. 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 ” is ON and “Bacth No.” is 20,
then after the subsequent 20 counts, the system will calculate a X-B QC value
and a corresponding control dot which will display on the graph.
There are three graphs of MCV, MCH and MCHC. The graphs will update at
once after each QC counting. QC results are arranged in graphs according to
storage time. The latest is on the left side and its serial number is 1.
QC Graph instruction:
1、 Graph abscissa indicates QC run times, ordinate indicates QC result.
2、 Every parameter graph can display at most 31 dots.
3、 Every parameter graph’s upper transverse line means assay plus limit.
4、 Every parameter graph’s lower transverse line means assay subtract
limit.
5、 The 3 values on the left side of parameter graph mean:
 upper limit —— assay limit;
 middle line —— assay;
 lower limit —— assay － limit.
If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot is under control range; If not, the dot is
not under control range.(see figure 8-8)
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Quality Control
Figure 8-8 X-B QC Graph
8.5.4 X-B QC Data Query
Operator can review QC results of three parameters through QC Query as the

figure 8-9 show.
Figure 8-9 X-B QC Data

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Quality Control
8.6 X-R QC
X-R QC needs controls. If run a background QC, the system will alarm QC
result is invalid.
8.6.1 X-R QC Edit
Before QC analysis, operator should finish QC Edit as follows:

1. At main interface, click QC, then click X-R QC, enter X-R QC Edit/Run
interface.(See figure 8-10).
Figure 8-10 QC edit/run
2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal

3; High 1, High 2, High 3.
3. Input lot NO., and select expiry date according to control instruction.
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Quality Control
8.6.2 X-R QC Run
When finish QC Edit, place the prepared control in Emerge place, the analyzer
will automatically aspirate the controls to start analysis.
In QC interface, system displays two control results, and calculates the mean
and range automatically after finishing the second QC count.
8.6.3 X-R QC Graph Analysis
X-R QC is similar to X QC; operator can review QC results of 24 parameters

through QC graphs. At X-R QC interface, click QC Analysis, enter graph
analysis interface.(see figure 8-11)
Figure 8-11 X-R QC Graph
X-R QC is different from X QC is, 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 in one interface, please select Level to
change.
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Quality Control
In X-R QC interface, there are X graph and R graph. X graph displays the
mean value dot while the R graph displays the range dot.
If operator selects group 1 of low level to perform QC twice, the dot correspond
with mean will be within X graph which correspond with low value 1. It also fits
for the dots of other groups — the dot correspond with range is within
corresponding R graph.
QC results are arranged in QC graph according to storage time, the latest is on

the left side and its serial number is 1.
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
－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
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Quality Control
×R.
 upper limit —— R upper limit＝B×R
 middle line —— R
 lower limit —— R lower limit＝C×R
not under control range.
8.6.4 X-R QC Data Query
When finish QC count, operator can review QC result of 24 parameters

through QC Query. Click QC Query to enter the interface as figure 8-12:
Figure 8-12 X-R QC Query
Click Pgprv or Pgnex to review the data. Operator could review 31 items data
at most. Click D_All to delete all data.
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Quality Control
The difference to X and L-J QC Query is: each page in the X-R QC Query
interface display three QC results that include mean value and range. But the
first page of the first two columns is total mean and average range in the X-R
QC Query.
The QC data would update after running two new controls.
8.7 X QC
In X QC, analyzer should aspirate control to operate QC. The operator could
perform QC with 20 test parameters. Considering the different needs, selecting
partial parameters for QC is available. 3 QC documents of high, normal and
low are provided for saving.
8.7.1 X QC Edit
Before QC analysis, operator should finish QC Edit as the follows:

1. In the main interface, click QC, then click X QC, enter X QC Edit
interface.(see figure 8-13)
Figure 8-13 X QC Edit
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Quality Control
2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal

3; High 1, High 2, High 3.
3. Input lot NO., and select expiry date according to control instruction.
4. Input assay and limit value according to control instruction.
After QC Edit, click Save, the dialog box that whether to save the result or not
will display.(see figure 8-14).
Figure 8-14 Save Settings
8.7.2 X QC Run
In X QC interface, click QC Run, enter the interface as figure 8-15:
Figure 8-15 X QC Run
Select the level, lot No. and expiry date that X QC Edit selected.
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Quality Control
In QC interface, system displays two control results, and calculates the mean
value automatically after finishing the second QC count. The column of mean
value show the mean value, the column of reference range show reference
range that user input in the QC Edit.
In the QC Run interface, place the prepared control in Emerge place; the
analyzer will automatically aspirate the controls to start analysis. If the
reference value of current group is empty, the system will alarm and can not
run the QC count. Back to QC edit interface, then input QC reference value
and limit of deviation for running QC count. If run a background QC, the system
will alarm QC result is invalid.
8.7.3 X QC Graph Analysis
After QC Run, operator can review QC results of 20 parameters through QC

Graph. In X QC interface, click QC Analysis, then enter the interface as figure
8-16:
Figure 8-16 X QC Analysis

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Quality Control
The dot on the X QC Graph indicates mean value of two QC results. there are
low, normal and high graphs. If select group 1 and low level to run a control
sample, the control dot will present in low 1 graph. Other selections will present
in corresponding graph.
QC results are arranged in graphs according to storage time. The latest is on
the left side and its serial number is 1.
QC graph instruction:
3、 Every parameter graph’s upper transverse line means assay plus limit.
4、 Every parameter graph’s lower transverse line means assay subtract
limit.
 upper limit —— assay plus limit
 middle line —— assay
 lower limit —— assay subtract limit
not under control range.
8.7.4 X QC Data Query
In X QC interface, click QC Query, enter QC Data Query interface, operator

can review the QC results of 20 parameters.(see figure 8-17)
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Quality Control
Figure 8-17 X QC Query
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Chapter 9 Calibration
9.1 Overview
Analyzer is detected and calibrated at the factory just prior to shipment. For
some reasons the result may be a little out of the range. Calibration is to insure
the accuracy of results. Calibration is a process to standardize the analyzer by
its deviation of value and parameter, calibration factor.
The instrument provides three calibration modes: Calibrator Calibration, Whole
Blood Calibration, and Manual Calibration.
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Calibration
CAUTION
 Only calibrators recommended by URIT can be used to accomplish the

calibration.
 Follow the use instruction to store and use calibrator.
 Check if the container is broken or cracked before using the calibrator.
 Make sure the calibrators are brought to room temperature and well mixed
slowly before use.
 Make sure the calibrators are within the expiry date.
 Make sure the analyzer without problem and precision meet the
requirement before calibration.
 Never apply to the laboratory or clinic use unless all the parameters are
accurately calibrated.
CAUTION
 Slowly remove a vial of blood calibrator from refrigerator, and warm to
room temperature by rubbing.
 Ensure the contents of a veil are completely suspended by inverting the
veil 30 times at least.
9.2 Calculate Frequency
To ensure analyzer’s precision and obtain reliable test results, the

parameters(WBC，RBC，PLT，HGB and MCV) should be calibrated in the following
situations:
(1) Working environment changes greatly;
(2) One or multiple parameters’ test results are moving;
(3) Any major component that affect the measurement is replaced;
(4) For long time no use;
(5) Requirement of the laboratory or the clinic;
(6) The reagent has been replaced;
(7) The analyzer presents deviation when running quality control.
MCV and HCT are relative parameters to each other, thus one can be obtained
from given value of the other. Only MCV can be calibrated by the analyzer.
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Calibration
Usually the manufacturer will give the value for MCV, HCT at the same time.
CAUTION
Considering all the clinic specimens, controls and calibrators ect that contain
human blood or serum as being potentially infectious, wear lab coats, gloves
and safety glasses, and follow require laboratory or clinic procedures when
handling these materials.
9.3 Preparation for Calibration
Before calibration, inspect the analyzer as the following requirements:

(1)Ensure the adequate reagents are in the shelf life and uncontaminated.
(2)Run a background test and make sure the results are accordance with table
9-1 background range;
Table 9-1 background range
Parameter Range
WBC ≤0.20x109/L
RBC ≤0.02x1012/L
HGB ≤1g/L
PLT ≤10.0x109/L
(3)The analyzer no errors;
(4)Verify the precision of the analyzer. At Hematology Analyzer, run a normal
control for 11 times, query the results from second to eleventh result precision
in Query. Make sure the CVs are accordance with table 9-2 precision;
Table 9-2 Precision

Parameter Precision（CV/%） Range
WBC ≤1.5% 4.0×109/L ~ 15.0×109/L
RBC ≤1.0% 3.00×1012/L ~ 6.00×1012/L
HGB ≤1.5% 100 g/L ~ 180g/L
HCT ≤2.0% 35% ~ 50%
MCV ≤1.0% 70fL ~ 120fL
PLT ≤4.0% 100×109/L ~ 500×109/L
(5)Carryover is determined by running high and low controls of WBC, RBC,

HGB, PLT. The high control is run in triplicate follow by three low control
running cycles. The carryover is calculated by the following formula and result
is confirmed to table 9-3:
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Calibration
Table 9-3 Carryover

Parameter Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤0.5%
9.4 Calibration Mode
9.4.1 Calibrated Calibration
In main interface, click Cal, then click Sta Cal into the interface as figure 9-1.
And calibrate as follows：
1. Input lot NO. and expiry date according to the calibrator instruction;
2. Select the parameter needed. Default select all;
3. Input the reference value according to the calibrator instruction and the
reference value of parameters do not need to be calibrated is blank.
4. Place the prepared calibrators in Emerge place; the analyzer will
automatically aspirate the calibrators to start analysis. The analyzer could
automatically calculate the mean value of 11 tests at most. URIT
recommend testing 3 to 5 times at least.
5. The new calibration coefficient is calculated according to the reference
value of calibrators and mean. Click Save to save the new calibration
coefficient that calculated by system automatically.
6. Click Print to print the new calibration coefficient; and click Back to exit
system calibration.
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Calibration
Figure 9-1 Calibration Mode
Note
 WBC Impedance Count (WIC) is the result of WBC that obtains through
electrical impedance method. And WBC Optical Count (WOC) is the result
of WBC that obtains through optical method.
 The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，
HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.
 Click Save to save the data before exiting system or the data will be lost.
7. Validation of Calibrated coefficient
After calibration, Urit recommend to follow the steps below to validate the
calibrated coefficients:
(1) Test the calibrators three times at least, and check whether the results are
within the allowed range.
(2) Analyze high, normal and low controls, and each control should be tested
for three times at least and check whether the results are within the
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Calibration
allowed range.
(3) Analyze three normal fresh blood samples, three times for each at least.
And check whether the results are within the allowed range.
The principles of new calibration value:
 Mean value=(value1+value2+value3+value4)/4
 New calibration value=(reference/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%
For example: the reference value of PLT of the calibrator is 220, current
calibration value is 103% and mean value is 230, thus the new calibration
value is;
New calibration value =103%×220/230
=98.52%
NOTE
 The calibration coefficient is allowed in the range of 70%~130%, if the
test values exceed the limit; the critical value in the limit range should
be selected as the new coefficient for calibration. And in that case,
operator should find out reasons and calibrate again.
9.4.2 Whole Blood Calibration
In main interface, click Cal, then select Blo Cal, enter the interface as the
figure 9-2.
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Calibration
Figure 9-2 Whole Blood Calibration

Calibrate the analyzer as follows:
(1) Select the desired parameters and sample No..
(2) Prepare 3 to 5 normal whole blood samples according to the collection
of blood sample in Chapter 7.
(3) Use 3~5 prepared samples and test each of them for three times at least to
get the mean. Consider the mean or the data that obtained through the
reference method as reference value.
(4) Place the prepared calibrators in Emerge place, the analyzer will
automatically aspirate the calibrators to start analysis, the analyzer could
automatically calculate the mean value of 11 tests at most. URIT
recommend testing 3 to 5 times at least)
(5)Repeat steps 4 until obtain more than three calibration coefficients. The
system will automatically calculate the mean value of each calibration
coefficient.
(6) Click Save to save the new calibration coefficient.
(7)Click Print to print the new calibration coefficient; Click Back to exit the
system calibration.
Note: WBC Impedance Count (WIC) is the result of WBC that obtain through
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Calibration
electrical impedance method. And WBC Optical Count (WOC) is the result of
WBC that obtains through optical method.
for three times at least and check whether the results are within the
allowed range.
9.4.3 Manual Calibration
Following the steps below to operate manual calibration:

1. Operator chooses whole blood single sampling mode in the main interface,
and uses calibrator to test more than three times to obtain mean.
2. Click Cal in the main interface ,enter calibration interface, and click Man
Cal into the interface as figure 9-3 show:
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Calibration
Figure 9-3 Manual Calibration
Note
 WBC Impedance Count (WIC) is the result of WBC that obtain through
electrical impedance method. And WBC Optical Count (WOC) is the result
of WBC that obtains through optics method.
 The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，
HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.
 Click Save to save the data before exit system calibration or the data will
be loss.
3. Input the assay and values of desired parameters of calibrator, and click Cal,
the system will automatically calculate the new calibration coefficient.(See
figure 9-4)
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Calibration
Figure 9-4 Calculate Coefficient
4. Click Save to save the new setting.

for three times at least and check whether the results are within the allowed
range.
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Calibration
113
Chapter 10 Maintenance
10.1 Overview
Routine care and regular maintenance are essential to keep the best status,
precision of the analyzer and minimize system problems, prolong the life span.
Procedures and instruction for preventive maintenance are discussed in this
chapter. More information is available at URIT Customer Support Centre.
Preventive maintenance should be performed daily, weekly and monthly.
Pertinent maintenance is also included in this Chapter according to actual
requirement.
CAUTION
 Considering all components’ surface may be potentially infectious, safety
protective measures should be taken to avoid infection, electric shock or
burn. Wear gloves when some cleaning do or maintenance works. Clean
hands with disinfectant after work.
10.2 Routine Maintenance
10.2.1 Daily Maintenance
1. Time Set
The analyzer is designed with auto-maintenance program. Instrument should
be set to automatically perform cleaning after continuously working on more
than 100 specimens. And background test should be set to perform
automatically after startup.
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Maintenance
Figure 10-1 Setup

2. Shutoff
To get correct results, it’s necessary to clean counting chambers and rinse the
flow system to prevent measurement errors caused by residues. Shutoff
program should be performed when the analyzer tests more than 500
specimens or finish today’s work. If continuously use the instrument, shutdown
program should be performed once at least every 24 hours. For detail
instructions, please refer to chapter 7 Daily Operation of Shutoff.
10.2.2 Weekly Maintenance
1. Surface Maintenance
Clear the smudge on the surface, especially the blood on the aspiration probe
and its surrounding, to remove the protein aggregation or debris to reduce the
possibility of the 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.
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Maintenance
2. Clean Shave Valve
Figure 10-2 Maintain

In the main interface select Maint, enter the interface as figure 10-2, and select
Clean Shear Valve to clean shear valve.
Regular cleaning of the shear valve ensures the accuracy and precision of
performance, prevent leak caused by reagent and blood residue. The shear
valve will be dirty after a long time use, so remove it and clean the rotary valve
with distilled water are necessary. Shear valve must be cleaned with detergent
firstly and then with distilled water again. For detailed instruction of removal,
please refer to Maintenance Manual or contact with URIT Customer Support
Centre.
10.2.3 Monthly Maintenance
1. Check and Clean Reagent Syringes

The Reagent Syringes need to be cleaned on a regular basis to prevent
reagent residue buildup, which may cause leakage or improper functioning.
Syringes should be cleaned one at a time to ensure that each syringe is
being placed in the correct position. Replace each syringe after it is cleaned
and then remove the next one to be cleaned.
Materials Required:
1. A large container filled with approximately 500 mL of deionized water;
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Maintenance
2. Clean and soft cloth;

3. Deionized water;
4. Small container of appropriate reagent to refill the clean syringes;
5. Appropriate personal protective equipment.
Clean Procedure:
1. Empty the flow system;
2. Remove the front covers to gain access to the Syringe Assembly.
3. Lift the syringe out of the snap-in bracket.
4. Aspirate the deionized water into the syringe until it is full. Continue to pull
on the plunger until it is removed from the barrel.
5. Rinse the plunger and barrel thoroughly with deinoized water. If the seal
ring has been worn to be replaced with new.
6. Carefully reinsert the plunger into the wet barrel.
7. When the syringe has been reinstalled, run several background counts
and observe the action of each syringe during the cycle. The plunger
should move smoothly up and down and the syringe should not leak.
CAUTION
 Do not push or pull on the plunger when the syringe is dry, as it may
damage the plunger. Avoid touching the plunger because oil from the
fingers may cause it to move erratically.
2. Maintenance of mechanical parts

It mainly aims at mechanism maintenance, including lubricate electricity axis, X,
Y leader of sampling organ etc.
3. Check and Replace Sample Aspiration peristaltic Pump Tube

The tube on the peristaltic pump needs to be replaced on a regular basis to
ensure proper fluid movement through the instrument. However, the frequency
of replacement depends on instrument use in each laboratory. Urit
recommends checking the soakage of peristaltic pump whether sufficiency at
least once monthly.
10.3 Maintenance procedure
In main interface, click Maint into the interface as figure 10-3:
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Maintenance
Figure 10-3 Maintenance
The analyzer offers the following three maintenance operations on flow

system:
 Prime: Aspirate all or depart of reagents to the corresponding tube to
replace the reagent.
 Clean: Clean count chamber, aspiration probe, shear valve ect.
 Empty: Empty count chamber, waste chamber, vacuum accumulator or all
tube.
10.3.1 Prime All
In the following conditions, perform this operation:

 Use the analyzer first time;
 Replace all reagents;
 Make sure the analyzer has problem.
Operate as the following steps:
1. Select Prime All in the Maintain interface;
2. The analyzer starts to replace diluent, detergent, sheath and lyse, and
display the progress bar at the bottom of screen.
3. The operation is completed and back to the Maintain interface.(see figure
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Maintenance
10-4)
CAUTION
 Considering all the specimens, controls, calibrators and waste etc. that
NOTE
 Keep the reagent still for a certain time to ensure it stable.
 After replace the diluent, detergent, sheath or lyse, perform background
count to ensure the background values are in the acceptable range.
Figure 10-4 Prime All
10.3.2 Prime Lyse
In the following three conditions, perform this operation:

 There are bubbles in the lyse tubing;
 The lyse in tubing is contaminated;
 Replace a new lyse.
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Maintenance
The procedures as follows:

1. Select Prime Lyse in MAINT interface;
2. The analyzer start to perform the function and display the process bar at
the bottom of screen;
3. The operation is completed and back to the MAINT interface.
10.3.3 Prime Diluent

 There are bubbles in the diluent tubing;
 The diluent in tubing is contaminated;
 Replace a new diluent.

1. Select Prime Diluent in MAINT interface;
10.3.4 Prime Detergent

 There are bubbles in the detergent tubing;
 The detergent in tubing is contaminated;
 Replace a new detergent.

1. Select Prime Detergent in MAINT interface;
10.3.5 Prime Sheath

 Three are bubbles in the WOC Flow Cell;
 The sheath in tubing is contaminated;
 Replace a new sheath.
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Maintenance

1. Select Prime Sheath in MAINT interface;
10.3.6 Cauterize Aperture
Cauterize both sides of the ruby aperture with a high voltage to clear protein,
dust etc that adhere or block on the aperture, to prevent and eliminate
blockage associating. The procedures as follows:
1. Select Cauterize Aperture in the MAINT interface;
the bottom of the screen;
3. The operation is completed and back to the MAINT interface.(see figure
10-5)
Figure 10-5 Cauterize Aperture
10.3.7 Flush Aperture
Flush aperture may rinse the ruby aperture and prevent and eliminate
blockage associating with Cauterize Aperture. The procedures as the follows:
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Maintenance
1. Select Flush Aperture in the MAINT interface;

10.3.8 Clean Transducers
CAUTION
 Considering all the specimens, controls, calibrators and waste etc. that
Clean Transducers function is to rinse transducers with diluent and scour it

with play bubbles. The procedures as the follows:
1. Select Clean Transducers in the MAINT interface;
If blockage is severe, select Empty WBC Cup or Empty RBC Cup, the analyzer
will automatically empty the liquid in both sides of the aperture. And remove
the ruby aperture, brush it with probe detergent or enzyme, then wash it with
distilled water. If the ruby aperture has been reinstalled, run several times of
background counts to check whether it is blockage.
CAUTION
 Consider the probe detergent is corrosive; operator should wear lab coats,
gloves, and follow required laboratory or clinical procedures.
10.3.9 Prepare Shipping
Perform this function before shipping or leave unused for a long time, the
procedures as the follows:
(1) Take out the diluent inlet tube connecting with the diluent port on the rear
panel from container, discharge the diluent remained in tube;
(2) Take out the lyse inlet tube connecting with the lyse port on the rear panel
from container, discharge the diluent remained in tube;
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Maintenance
(3) Take out the detergent inlet tube connecting with the detergent port on the
rear panel from the container, discharge the detergent remained in tube;
(4) Take out the sheath inlet tube connecting with the sheath port on the rear
panel from container, discharge the sheath remained in tube;
(5) Keep the remaining reagents in their containers and store them according
to instructions. Operator should establish and confirm to the effective
storage measures to prevent reagent from deteriorated, misusage or
misdrinking. The reagent should be away from temperature extremes.
(6) Select Prepare Shipping in the MAINT interface;
(7) The analyzer start to perform the function and display the process bar at
(8) The operation is completed and back to the MAINT interface. (see the
figure 10-7)
Figure 10-7 Prepare Shipping
10.3.10 Other Maintenances
Clean Aspiration Probe--------scour the inside of aspiration probe with diluent.

Clean Shear Valve--------rinse the shear vale with diluent.
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Maintenance
Clean sheath channel--------clean Pre-mixing chamber and WOC Flow Cell.

Clean Impedance Channels-------clean WBC/RBC counting chamber and
volumetric metering tube.
Open Press Control Module------provide pressure for press chamber and
negative press for negative press chamber.
Close Press Control Module--------close the pressure on the press chamber
and negative press chamber.
Empty Waste Chamber 1/2----------discharge the waste remained in waste
chamber 1 or chamber 2 to the outside of analyzer.
Empty WBC/RBC Cup---------------empty the diluent remained in the WBC/RBC
cup.
Empty Shear Valve---------empty the liquid stored in the shear valve.
124
Chapter11 Troubleshooting
11.1 Overview
This chapter gives instructions for identifying, troubleshooting and correction of

analyzer problems. If the malfunction is not solved according to the guidance or more
detail information is needed, please contact URIT Customer Support Centre.
NOTE: This manual is not a maintenance manual, but provides the measurements
when the analyzer malfunction alarm only.
Considering the analyzer handling the materials that contain human blood or serum
as being potentially infectious, please follow the established bio-safety procedure
when maintain or troubleshoot the analyzer.
11.2 Troubleshooting Guidance
Troubleshooting Guidance is designed to assist operator in identifying and resolving

analyzer problems. Instruction is also given for obtaining technical assistance
immediately from URIT 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
Step1: 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 troubleshooting process moves quickly to next step.
Step2: Problem Isolation means further classifying the problem. Analyzer problems
are generally divided into three categories:
(1) Hardware component related;
(2) Software computer programs related;
125
Troubleshooting
(3) Measurement related to sample analysis.

Hardware and software problems can only be corrected by a URIT authorized
engineer. The operator can correct sample measurement problems with assistance
from URIT engineers.
Step3: Corrective Action

Corrective Action means operator taking appropriate action to correct the problem. If
operator can correct the problem, with or without technical assistance from the
manufacture, normal operation can quickly resume.
11.3 Obtaining Technical Assistance
Technical assistance is obtained by calling the URIT 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 number of the reagents (lyse, diluent, detergent etc. )
(5) Related 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 Guidance.
11.4 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 URIT Customer
Support Centre.
126
Troubleshooting
11.4.1 Faults Related to Reagents
Fault Probable Cause Corrective Action

Lyse empty Lyse is run out 1.Check that if the lyse is run out.
or lyse inlet tube 2.Perform Maint→Prime Lyse.
is blocked. 3.If fault still occurs, please contact with URIT.
Diluent empty Diluent is run 1.Check that if diulent is run out.
out。 2.Perform Maint→Prime Diluent.
3.If fault still occurs, please contact with URIT.
Detergent Detergent is 1.Check that if the detergent is run out.
empty run out. 2.Perform Maint→Prime Detergent.
3.If the fault still occurs, please contact with
URIT.
Sheath empty Sheath is run 1.Check that if the sheath is run out.
out 2.Perform Maint→Prime Sheath.
3.If the fault still occurs, please contact with
URIT.
Waste full Waste 1.Check that if the waste container is full.
container is full 2.Check that if the sensor is wet or short circuit.
or waste 3.If the fault still occurs, please contact with
sensor is in fault. URIT.
127
Troubleshooting
11.4.2 Faults Related to Test Value
Fault Probable Cause Correction Action

High Reagents are 1.Check that if the reagents are contaminated or
background contaminated or overdue.
value overdue; 2.Perform Maint→Prime All to rinse the flow
Reagent tube system.
contaminated 3.If the fault still occurs, perform Maint→Clean
。 Transducers. Run a background test again to
check if the fault disappeared.
4.If the fault still occurs, please contact with URIT.
HGB HGB 1.Select Service to enter the system test interface,

inaccuracy background and check the HGB_AMP_SET.
voltage hopping 2.If the HGB_AMP_SET is out of range, contact
with the URIT to modify the value.
WBC clog ruby aperture 1.Perform Cauterize Aperture or Flush Aperture in

or RBC clog clogged; WBC the MAINT interface. Then run a background
counting time counting to check the count time.
incorrect; 2.If fault still occurs, inject probe detergent with the
solenoid valve syring into WBC/RBC cup to soak the ruby
problem aperture.
3.If fault still occurs, please contact with URIT.
WBC bubble Diluent or 1.Check that the diluent or detergent if run out.
or RBC detergent run 2.Check the reagent tubing connection, prevent
bubble out or deficient leakage.
Reagent tubing 3.Perform Tubing Clean in MAINT interface.
loose leads to 4.If the fault still occurs, please contact with URIT.
leakage
128
Troubleshooting
11.4.3 Fault Related to Hard Ware
Fault Probable Cause Correction Action

No 1.The power wire is 1.Check the power wire connection.
response not connection well 2.Check whether the fuse has burned out.
when with the power 3.If the fault still occurs, turn off the power, and contact
startup socket. with URIT.
2.The fuse may be
burnout.
Moto 1.Moto connecting 1.Turn off the power, and contact with URIT.
sounds wire loose.
abnormally 2.Travel Optocoupler
problem.
3.Moto problem;
4.Moto drive circuit
problem.
Counting 1.Ruby aperture 1.Perform Empty WBC/RBC Cup to empty the liquid
time is so clogged. both sides of the ruby aperture. And move the ruby
long or no 2.Valve no movement. aperture and brush it with probe detergent or
counting enzyme, then wash it with distilled water. When the
time ruby aperture has been reinstalled, run several
background counts to check whether it is block
aging.
Printer no 1.Connecting wire 1.Check the power wire and connecting wire of the
response problem. printer. If the printer still doesn’t work, please re-plug
2.Printer problem wires and restart the computer and printer.
2.If the fault still occurs, connect the printer to another
normal computer separately and install the driver to
test the printer if it is normal.
129
Appendix A Specifications
A.1 Technical Specifications
A.1.1 Parameters
Abbreviation Full Name Unit

WBC White Blood Cell Count 109cells/L
LYM% Lymphocyte Percent %
MON% Monocyte Percent %
NEU% Neutrophile Percent %
EOS% Eosinophile Percent %
BAS% Basophil Percent %
LYM# Lymphocyte Count 109cells/L
MON# Monocyte Count 109cells/L
NEU# Neutrophile Granulocyte Count 109cells/L
EOS# Eosinophile Granulocyte Count 109cells/L
BAS# Basophil Granulocyte Count 109cells/L
RBC Red Blood Cell Count 1012cells/L
HGB Hemoglobin g/L
HCT Hematocrit (relative volume of erythrocytes) %
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
MCHC Mean Corpuscular Hemoglobin Concentration g/L
RDW_CV Red Blood Cell Distribution Width repeat %
precision
RDW_SD Red Blood Cell Distribution Width STDEV fL
PLT Platelet Count 109cells/L
MPV Mean Platelet Volume fL
PDW Platelet Distribution Width fL
PCT Plateletcrit %
P_LCC Large Platelet Count 109cells/L
P_LCR Large Platelet Percent %
RETIC Reticulocyte %
RETIC_ABS Reticulocyte absolute number 109/ul
IIRF Immature Reticulocyte Fraction %
130
A.1.2 Test Speed
The test speed of Whole Blood Automated Sampling Mode is no less than 100
samples per hour, and the Whole Blood Single Sampling Mode too.
A.1.3 QC Mode
There are four QC modes, L-J QC, X-B QC, X-R QC and X QC.
A.1.4 Reagents of Product
The reagents used in analyzer: diluent, lyse, detergent and sheath. The detail
information about them is in A.4 Reagent Specification.
A.1.5 Calibration Mode
The modes of calibration are Calibrator Calibration, Whole Blood Calibration,

and Manual Calibration.
A.1.6 Parameters Measurement and Calculation
(1) The laser light method for determining the quantity and Five-Part-Diff of
WBC.
(2) Electrical impedance method for determining the quantity of RBC and PLT.
(3) The colorimetric method for determining the content of HGB.
(4) MCV，HCT，RDW，MPV，PDW，MCH，MCHC，PCT are obtained directly
by calculating the stored data.
A.1.7 Input/Output Devices
(1) Outer computer;

(2) Outer printer (optional);
131
CAUTION
 Computer, printer and other external devices must be passed CCC(C&E)
Compulsory Certification. It may cause the system work improper system
work and personal injury by using substandard external devices.
A.2 Physical Specifications
A.2.1 Power Requirement
Optimum work Voltage Work Voltage range Frequency

AC220V AC220V±22V 50/60 Hz
A.2.2 Environment Requirement
(1) Temperature: 15°C~35°C;

(2) Relative Humidity: ≤85％;
(3) Barometric Pressure: 60kPa~106kPa;
A.2.3 Storage Environment
(1) Temperature: -20°C~55°C;

(2) Relative Humidity: ≤95%;
(3) Barometric Pressure: 50kPa~106kPa;
A.2.4 Size and Weight
(1) Height: about 676.5mm（26.6 inch）;

(2) Length: about 760mm（29.9 inch） ;
(3) Width: about 684mm（26.9 inch）;
(4) Weight: about 91.5Kg;
A.2.5 Waste Disposal
According to the standard of local or nation dispose the waste.
132
A.2.6 Minimum Sample Volume
(1) Minimum required blood sample: 1ml;

(2) Analyzer aspirate required sample: 160μl;
A.2.7 Dilution Ratio
(1) WBC: about 1:400

(2) RBC/PLT about 1:12500
A.2.8 Counting Aperture
(1) WBC: 100μm;

(2) RBC/PLT: 68μm;
A.2.9 HGB measurement
(1) Measure HGB in WBC/HGB cup;

(2) The illuminant is led, and the wavelength is 540nm.
A.3 Performance Index
A.3.1 Precision
Parameter Precision Range Acceptable Limits

（CV%）
WBC 4.0 x109 /L ~15.0x109 /L ≤1.5%
RBC 3.00 x1012 /L ~6.00x1012 ≤1.0%
/L
HGB 100 g/L ~180 g/L ≤1.5%
PLT 100 x109 /L ~500x109 /L ≤4.0%
HCT / 35%~50% ≤2.0%
MCV 70 fL ~120 fL ≤1.0%
133
A.3.2 Linearity
Parameter Linearity Range Acceptable Limits

0 x109 /L ~10.0x109 /L ≦±0.3 x109 /L
WBC 10.1 x109 /L ~99.9x109 ≦±5%
/L
0.10 x1012 /L ≦±0.05 x1012 /L
~1.00x1012 /L
RBC
1.01 x1012 /L ≦±5%
~7.00x1012 /L
0 g/L ~70 g/L ≦±2 g/L
HGB
71 g/L ~300 g/L ≦±2%
0x109 /L ~100x109 /L ≦±10 x109 /L
PLT
101 x109 /L ~999x109 /L ≦±10%
A.3.3 Accuracy of WBC five part differential
The measurement values of NEU, LYM, MON, EOS and BAS are in the
acceptable range. (99% of the confidence interval)
A.3.4 Carryover
Parameter Measurement Result

WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤0.5%
A.3.5 Background Counting
Parameter Measured Value Range

WBC ≤0.20x109 /L
RBC ≤0.02x1012 /L
HGB ≤1g /L
PLT ≤10.0x109 /L
134
A.3.6 Accuracy
Parameter Acceptable Range (%)

WBC ≦±4.0%
RBC ≦±2.0%
HGB ≦±2.0%
HCT / MCV ≦±2.5%
PLT ≦±7.0%
A.3.7 Display Range of Main Parameter
Parameter Display Range

WBC 0～99.00 x 109/L
RBC 0～99.00 x 1012/L
HGB 0～300g/L
HCT 0%～99%
PLT 0～2000 x 109/L
A.4 Reagent Specifications
Name Model Specification

Diluent URIT-5500 20L
Detergent URIT-5500 5L/10L
Sheath URIT-5500 20L
Lyse URIT-5500 500mL/1L
CAUTION: Do not pour the remaining reagent in it when replace a new

reagent, or it will lead to cross contamination of the reagents.
135
A.5 Reagent Consumption
Operation Diluent Detergent Sheath Lyse Probe

Detergent
Startup 35ml 44ml 32ml 3ml 0ml
Counting 40ml 20ml 12ml 0.7ml 0ml
Prime 35ml 40ml 30ml 3ml 0ml
(Clean)
Shutoff 30ml 30ml 28ml 0ml 0ml
A.6 Parameters Alert Messages
Suspect Suspect
Paramet Interpretive
Data Alerts Parameter Population
er Messages
Flags Flags
WBC If the result below WBC NWBC Leukopenia
lower limit, it displays in FWBC Leukocytosis
blue and marked L; NRBC
If the result above RRBC When RRBC?
upper limit, it displays alarm,switch to
in red and marked H; RRBC mode for
counting again.
Differenti Same as WBC DFLT BAND Neutropenia
al (NLMEB) IG Neutrophilia
NEU BLAST Lymphopenia
LYM VARLYM Lymphocytosis
MON Monocytosis
EOS Eosinophilia
BAS Basophilia
PLT Same as WBC LRI MPV Thrombocytopenia
MPV URI Suppressed Thrombocytosis
LURI (not Microcytic PLT
PLTR displayed or Macrocytic PLT
printed )
136
Appendix B Toxic and Hazardous
Substances or Elements
Toxic and Hazardous Substances or Elements

Polybromi-
Polybrominate-
Parts Plumbum Mercur Cadmiu Chromium nated
d Diphenyl
（Pb） y（Hg） m（Cd） VI（Cr(VI)） Biphanyls(
Ethers（PBDE）
PBB)
Shell ○ ○ ○ ○ ○ ○
Printed
circuit
× ○ ○ ○ ○ ○
board
Assembly
Sheet
metal ○ ○ ○ × ○ ○
Parts
Hos Plastic
t ○ ○ ○ ○ ○ ○
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 sonme 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.
137
Appendix C Daily Operation Procedure
1. Startup and Run

(1) Make sure the power wire is properly connected; None reagent tubes is
bending or detached; Check if the waste container is full.
(2) Turn on the power of computer and analyzer;
(3) The analyzer starts to performing initialized self-checking program
automatically and rinse the flow system, then goes to main Interface. It’s
takes about 5 to 8 minutes.
(4) Perform a background count and QC control to ensure the analyzer
operates normally.
(5) Whole Blood Automated Sampling mode for analyzing a group of
specimens and Whole Blood Single Sampling mode for an emergency
specimen.
(6) Query, output and print the data.
(7) Necessary maintenance should be operated according to the situation.
2. Shutoff Procedures
(1) Click Exit in the main interface to shutoff;
(2) The analyzer automatically rinse the flow system;
(3) Turn off the power switches off the analyzer and computer when display
“Thank you for using, please turn off the power” display on the screen.
3. Daily Maintenance (perform it before shutoff)

(1) The analyzer will automatically perform daily maintenance with the time set
according to the quantity of the test samples.
(2) If ruby aperture is clogged, perform “Cauterize Aperture”, “Flush Aperture”
and “Clean Transducers” procedures in the MAINT interface.
(3) When continuously use the analyzer, shutoff procedure should be
performed at least once every 24 hours.
4. Weekly Maintenance
(1) The surface maintenance of the analyzer.
(2) Remove and disassemble the shear valve, brush them with enzyme, and
clean it with distilled water before install.
(3) Clean the slot of the auto-sample loader and tube racks.
5. Monthly Maintenance
(1) Check and clean the reagent syringes.
(2) Mechanical parts maintenance.
(3) Check or replace the sample aspiration peristaltic pump tubing.
138
6. Other Maintenances
If the ruby aperture is block aging severely, select Empty WBC Cup or Empty
RBC Cup, the analyzer will automatically empty the liquid in both sides of the
aperture. And remove the ruby aperture, brush it with probe detergent or
enzyme, then wash it with distilled water. When the ruby aperture has been
reinstalled, run several times of background counts to check whether it is
blockage.
139
Appendix D HL7 One-way Communication Protocol
A. Communication Protocol
Information is transferred by the following methods.
<SB>information<EB><CR>
<SB> is Start Block Character needs 1byte corresponds to ASCII <VT>
hexadecimal 0x0B
<EB> is End Block Character needs 1byte corresponds to ASCII <FS>
Hexadecimal 0x1C
<CR> is Carriage Return needs 1byte corresponds to ASCII <CR>
hexadecimal 0x0D
Information is the data that we want to transfer. Please refer to the following for
details.
B. Information Grammar
1. Delimiter
| --- Fields Delimiter
^ --- Component Delimiter
& --- Subcomponent Delimiter
~ --- Repeat Delimiter
\ --- Escape Character
2. Data Type
CX extended composite id whith check digit
CE code element
CM composite
CQ composite quantity with units
DR datetime range
DT data
DLN driver’s license number
EI entity identifier
HD hierarchic designator
FN family name
FT formatter text
IS coded value for user-defined tables
ID coded values for HL7 tables
JCC job code
NM numeric
PT processing type
PL person location
ST string
SI sequence ID
TS time stamp
140
TQ timing quantity
TX text data
XAD extended address
XCN extended composite ID number and name
XON extended composite name and ID number for organizations
XPN extended person name
XTN extended telecommunications number
VID version identifier
3. Field Meaning
3.1. There is a message header at the beginning of each message. It is MSH
field.
The meaning of MSH is shown as below
No. Field Data Type Length Explanation
1 Field mark ST 1 Separatora
2 Encoding chars ST 4 Separator listing
3 Sending Application EI 180 Sending end applications
4 Sending Facility EI 180 Sending end facility
5 Receiving Application EI 180 Receiving end applications
6 Receiving Facility EI 180 Receiving end facility
7 DateTime Message TS 26 Current message event,
system time
8 Security ST 40 Security
9 MessageType CM 7 Message Type
10 Message Control ID ST 20 Message control ID is used to
distinguish different
messages. See the table
below.
11 Processing ID PT 3 Dispose of ID P Product
12 VersinID VID 60 HL7 version is 2.3.1
13 Application IS 1 Set null
Acknowledgment
Type
14 Retain
15 Retain
16 Retain
17 Retain
18 Encoder ST Encoding is UNICODE
MSH-10 Description
0001 Instrument transmits results automatically.
1001 Lis responses, instrument transmits results automatically.
141
Example:
MSH|^~\&|URIT|UT-5200|LIS|PC|20100930100436||ORU^R01|0001|P|2.3.1|1|||||UNICO
DE
3.2. PID--- Definition of patients' data field

1 Set ID PID SI 4 Identify different fields, fill
with 1 generally.
2 Patient ID EI 20 Patient ID., hospital No.,
set null
3 Patient Identifier List CX 20 Indicate batch number
when QC
4 Alternate Patient ID CX 20 Bed No.
5 PatientName XPN 48 Name
6 Mother’s Maiden Name XPN 48 Mother’s Maiden Name,
set null
7 Date/Time of Birth TS 26 Birthday；
Indicate validity when QC
8 Sex IS 1 Male or female
9 Patient Alias XPN 48 Retain patient alias
10 Race CE 80 Retain race
11 Patient Address XAD 106 Retain patient address
12 County Code IS 4 Retain county code
13 Phone Number XTN 40 Retain phone No.
13 Phone Number Bus XTN 40 Retain office phone No.
14 Primary Language CE 60 Retain mother tongue
15 Marital Status CE 80 Retain Marital Status
16 Religion CE 80 Retain religion
… The rest part is not
needed to be filled.
Example: PID|1|1010051|A1123145|15|Mary||19811011|M
3.3. PV1---Definition of patient visiting record field

1 Set ID PV1 SI 4 Identify different fields, fill
with 1 generally.
2 Patient Class IS 1 Patient category
3 Assigned Patient PL 80 Be used to indicate
Location patient department
142
Example: PV1|1Clinic| Surgery |
3.4. OBR--- Definition of Doctor's Advice
No Field Data Length Explanation
Type
1 Set ID OBR SI 4 Identify different fields, fill
with 1 generally.
2 Placer Order Number EI 22 Serial number
3 Assigned Patient EI 22 Sample number
Location
4 Universal Service ID CE 200 Universal service ID
5 Priority ID 2 Priority set null
6 Requested DateTime TS 26 Application time
7 ObservationDatetime TS 26 Inspection starting time, set
null
8 Observation DateTime TS 26 Inspection end time
end
9 Collection Volume CQ 20 Specimen collection
capacity, set null
10 Collector Identifier XCN 60 Sender name
11 SPE ActionCode ID 1 Sample handling code, set
null
12 Danger Code CE 60 Danger code alarm
13 Relecant Clinical Info ST 200 "Diagnosis" ^ "Remark",
each length should not be
more than 100 bytes
14 SPE Received DateTime TS 26 Sample receiving time
15 SPE Source CM 300 Sample classification, blood,
urine etc.
16 Ordering Provider XCN 120 Inspector name
17 OrderCallback Phone XTN 40 Callback phone, set null
Number
18 Placer Field1 ST 60 Sender field 1, Inspection
department
19 Placer Field2 ST 60 Set null
20 Filler Field1 ST 60 Operator field 1, set null
… The rest part is not Set null
needed to be filled.
28 Result Copies to XCN 60 Verifier
Example：
OBR|1|1010051|000001|URITÛT-5200||20101010093000||20101010093500||sender|||
diagnosis^remark||BLD|Inspector||||||||||||verifier|
143
3.5. OBX
Type
1 Set ID OBX SI 4 Identify different fields, fill with
1 generally.
2 Value Type ID 3 NM means figure type, ST
means value type
3 Observation Identifier CE 590 Observe identifier name
4 Observation SubID ST 20 Observe sub-id project name
5 Observation value ST 65535 Check result
6 Units CE 90 Unit
7 References Range ST 90 Reference range is from small
to big; QC means reference
value and deviation.
8 Abnormal Flags ID 5 H,L and N indicate high, low
and normal value respectively.
9 Probability ID 5 Probability, set null
10 Nature of Abnormal Test ID 2 C indicates WBC and RBC
clog; B indicates bubble,
when normal, set null
11 Observe Status ID 1 Observe results, take F for
final result.
12 Date Last Observe TS 26 The time for observing normal
value, set null
13 User Defined Access ST 20 Original results
Checks
Example: OBX|1|NM|WBC||8.21|10^9/L|4.00-10.00|L|||F||
3.6. MSA
No Field Data Type Length Explanation
1 Acknowledgment Code ID 2 Confirmation code: AA is
for receiving, AE for error
and AR for refusing.
2 Message Control ID ST 20
3 Text Message ST 80 Message

4 Expected Sequence NM 15
Number
5 Delayed ID 1
Acknowledgment Type
6 Error Condition CE 100 Error condition
144
MMSA-6 is used to indicate different errors, see the table below.
MSA-1 MSA-6 MSA-3 False Description
AA 0 Message accepted Receive successfully
AE 101 Segment sequence error The fields order in message is
not correct, or the necessary
fields are lost.
102 Required field missing Necessary fields of a
paragraph are lost.
103 Data type error Data type of fields is false. For
example, digital is changed
into character.
104 Key not found Key identifier is not found
105 Resend Resend data
AR 201 Unsupported message Unsupported message type

type
202 Unsupported event code Unsupported event code
203 Unsupported processing Unsupported processing ID
id
204 Unsupported version id Unsupported version ID
205 Unknown key identifier Unknown key identifier，For
example, transmit an
inexistent patient information.
206 Duplicate key identifier Duplicate key identifier
207 Application record locked Affairs in application storage
level can't be carried out. For
example, database is locked
208 Application internal error Other errors in unknown
application.
209 Application unready Application is not ready
3.7. ERR
1 Error Code and Location CM 80 Code and position error
ERR-1
Assembly 1 Assembly 2 Assembly 3 Explanation
001 Record already Test tube No. The test tube record has already
exist existed.
002 Lis Recieved Test tube No. Lis receiving error, resending data
Faild is required.
003 Read REQ error Test tube No. Fail to read request form.
004 Read BarCode Test tube rack No. Instrument fails to read test tube
145
Errer number.
3.8. QRD
Type
1 Query Date/Time TS 26 Query time
2 Query Format Code ID 1 D （display format）
3 Query Priority ID 1 I（Immediate）
4 Query ID ST 10 Distinguish different
queries ,accumulate with query
times. The initial value is 1.
5 Deferred Response Type ID 1 Set null
6 Deferred Response TS 26 Set null
Date/Time
7 Quantity Limited CQ 10 RD（Records）
Request
8 Who Subject Filter XCN 60 Take as a test tube code \
sample number.
9 What Subject Filter CE 60 OTH
10 What Department Data CE 60 Set null
Code
11 What Data Code Value CM 20 Set null
Qual.
12 Query Results Level ID 1
3.9. QRF
1 Where Subject Filter ST 20 Take UT-5200
2 When Data Start TS 26 Application time
Date/Time
3 When Data End TS 26 Deadline
Date/Time
4 What User Qualifier ST 60 Set null
5 Other QRY Subject Filter ST 60 Set null
6 Which Date/Time ID 12 RCT(Specimen receipt
Qualifier date/time, receipt of
specimen in filling
ancillary (Lab))
7 Which Date/Time Status ID 12 ANY(Any status)
Qualifier
8 Date/Time Selection ID 12 ALL(All values within the
Qualifier range)
9 When Quantity/Timing TQ 60 Set null
146
Qualifier
3.10. QSP
1 Set ID - DSP 4 SI
2 Display Level SI 4
3 Data Line TX 300 Content queried
4 Logical Break Point ST 4
5 Result ID TX 20
Use QSP-1 to distinguish different queried information in QSP fields.

Set ID – DSP Message
1 Test Tube Number
2 Serial Number
3 Name
4 Sex
5 Birthday
6 Blood Type
7 Group
8 Patient Number
9 Bed Number
10 Patient Type
11 Department
12 Sender
13 Inspector
14 Verifier
15 BLDV is for venous blood, BLDC is for peripheral blood.
16 Clinical diagnosis
17 Remark
18 Sampling time, sending time
19 inspection time
Example
DSP|1||Mary||<CR>
147
4. Communication process
4.1. Instrument transmits test results to lis server
UT-5200 Lis
ORU^R01 server
<SB>
MSH
PID
PV1
OBR
OBX
OBX
……
<EB><CR>
OBX fields can be repeated. Transmitted test results include patient information, 24
parameters, 2 histograms and 2 scatter plots. The 2 histograms and 2 scatter plots are
BMP format and transmitted with base64 code;
For example：
Instrument transmits test results to lis server
<SB>
MSH|^~\&|URIT|UT-5200|LIS|PC|20110627144458||ORU^R01|0001|P|2.3.1||||||UNICOD
E<CR>
PID|1||||||||<CR>
PV1|1|||<CR>
OBR|1||BAR101010101|URITÛT-5200||||01110621143134|||||^||||||||||||||||<CR>
OBX|1|NM|WBC||110.0|10^9/L|40.0-100.0|H|||F|||||||<CR>
OBX|2|NM|LYM||35.57|%|20.00-40.00||||F|||||||<CR>
OBX|3|NM|MON||5.84|%|3.00-8.00||||F|||||||<CR>
OBX|4|NM|NEU||57.37|%|50.00-70.00||||F|||||||<CR>
OBX|5|NM|EOS||1.14|%|0.50-5.00||||F|||||||<CR>
OBX|6|NM|BASO||0.08|%|0.00-1.00||||F|||||||<CR>
OBX|7|NM|LYM#||284.5|10^9/L|80.0-400.0||||F|||||||<CR>
OBX|8|NM|MON#||46.7|10^9/L|10.0-80.0||||F|||||||<CR>
OBX|9|NM|NEU#||458.9|10^9/L|200.0-700.0||||F|||||||<CR>
OBX|10|NM|EOS#||9.1|10^9/L|0.0-50.0||||F|||||||<CR>
OBX|11|NM|BASO#||0.6|10^9/L|0.0-10.0||||F|||||||<CR>
148
OBX|12|NM|RBC||4.49|10^12/L|3.50-5.50||||F|||||||<CR>
OBX|13|NM|HGB||0|g/L|0-1079738368|L|||F|||||||<CR>
OBX|14|NM|HCT||26.4|%|37.0-50.0|L|||F|||||||<CR>
OBX|15|NM|MCV||59.0|fL|80.0-100.0|L|||F|||||||<CR>
OBX|16|NM|MCH||24.0|pg|27.0-31.0|L|||F|||||||<CR>
OBX|17|NM|MCHC||0|g/L|0-1081344000|H|||F|||||||<CR>
OBX|18|NM|RDW_CV||16.1|%|11.5-14.5|H|||F||||||<CR>
OBX|19|NM|RDW_SD||45.0|fL|35.0-56.0||||F||||||<CR>
OBX|20|NM|PLT||0|10^9/L|0-1079574528|H|||F|||||||<CR>
OBX|21|NM|MPV||12.3|fL|7.0-11.0|H|||F|||||||<CR>
OBX|22|NM|PDW||14.7|fL|15.0-17.0|L|||F|||||||<CR>
OBX|23|NM|PCT||0.41|%|0.10-0.28|H|||F|||||||<CR>
OBX|24|NM|P_LCR||1.37|%|0.50-1.80||||F|||||||<CR>
OBX|25NM|RBCHistogram^LeftLine||1||||||F||||||<CR>
OBX|26|NM|RBCHistogram^RightLine||118||||||F||||||<CR>
OBX|27|ED|RBCHistogram||UT5200^Histogram^512Byte^HEX^00000000000000000000
000000000000000000000102030406080a0d010101020203040405060708090a0b0c0c0
d0d0c0c0c0b0a0a09080807070606060505050404040403030303020202020101010101
010f0d0c0a0908070706050505040404030303020202020101010101000000000000000
00000000000000000000000000000000000000000000000000000000000000000000000
00000000000000000000000000000000000000000000000000000000000000000000000
00000000000000000000000000000000000000000000000000000000000000000000000
000000000000000000000000000000000000000000000000000000000000000000||||||F||
||||<CR>
OBX|28|NM|PLTHistogram^LeftLine||8||||||F||||||<CR>
OBX|29|NM|PLTHistogram^RightLine||127||||||F||||||<CR>
OBX|30|ED|PLTHistogram||UT5200^Histogram^256Byte^HEX^00000000050506010102
03040505060708090a0b0b0b0b0b0b0a0a0a0b0b0b0b0c0c0b0b0a0a090807060605050
50506060606060505050404030303030202020202020202020202020202020202020202
01010101010101020202020203030303020202020101010101010202020202020202020
20202020203030303030303||||||F||||||<CR>
OBX|31|ED|S0_S10DIFFScattergram||UT5200Îmage^BMP^Base64^Qk32lgMAAA……<
CR>
OBX|32|ED|S90_S90DDIFFScattergram||UT5200Îmage^BMP^Base64^Qk32lgMAAA…
…<CR>
<EB><CR>
149

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URIT 5500 Opeation Manual (V2 0 2012 12 20

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Five-Part-Diff Auto Hematology Analyzer

URIT Medical Electronic Co., Ltd.

1) Carefully read this manual before first operating the analyzer.

URIT Medical Electronic Co., Ltd.

Supplyed by URIT Medical Electronic Co., Ltd.

Wellkang Ltd t/a Wellkang Tech Consulting

URIT-5500 Five-Part-Diff Auto Hematology Analyzer is an in vitro diagnostic

1.2 Hazard Sign

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

This manual uses the following warning conventions:

Detailed Specification Appendix A Specifications

Item Content Explanation

Whole blood single (emergency)

sampling mode 160 µL±5％

Sample Use the automati c washing Avoid samples c ross

HGB Tes t Cyanide-free qua te rn ary Environmental reg ents can

W ith automatic Improve the lifetime of equipment, and

With 9 different groups normal Can be adjusted according to different

In addition to the safety use information, the general matters of operators in

2.2 Special Requirements

 URIT-5500 five-Part-Diff Automated Hematology Analyzer is for blood cell

2.3 General Requirements

2.4 Electromagnetism Security

 Check marks on the package.

 As a precision electro-optical instrument, maintenance is necessary for

2.11 Security Sign

Be ware of electric shock

Protect from heat and radioactive

In vitro diagnostic medical device

 This medical instrument must be operated by well-trained personnel

2.13 Computer Virus

URIT-5500 Five-Part-Diff Auto Hematology Analyzer is an vitro diagnostic

 The instrument needs several people work together to move since it is

The analyzer is consisted of host, computer and an external printer (optional).

Figure 3-1A Front View

Figure 3-1B Front View (Remove the front cover)

1---WBC/HGB Counting Chamber 2----LMS Counting Board

Figure 3-2 A Left Side View

1--- Left Side Door Holder 2--- Detergent Reservoir

Figure 3-3 A Right Side view 2

1--- Right Side Door Holder 2--- Power Switch

Figure 3-4 Rear View

1--- Grounding Terminal 2---- COM Port

3.4 Counting Operation Screen

Figure 3-6 Counting Interface

This interface can be divided into the following areas by functions:

Table 3-2 Main Menu Button

2. Data Edit Area

3.5 Reagent, Control and Calibrator

of the analyzer and serious mistakes, even accidents.

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

3.5.5 Probe Detergent

Probe detergent contains effective oxide to clean the stubbornly-blocked

 Detergent and probe detergent is alkali cleaning agent

(4) If ingested, induce vomiting and seek medical treatment immediately.

3.5.6 Control and Calibrator

Control and calibrator are for quality testing and calibration.

 Environment Requirements: Temperature: 15 ℃ ~ 35 ℃ ; Relative

Installation of the analyzer by an unauthorized or untrained person could result

4.2 Unpacking and Inspection

(1) Quantity of accessories according to the packing list.

Do contact URIT Customer Support Center if any problem occurs.

4.3 Space Requirements