URIT-3010 Operation Manual

URIT-3010
Automated Hematology Analyzer
Operation 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.
2
Contents
Copyright and Declaration ............................................................................................... I
Guidance.......................................................................................................................... III
Chapter 1 System Description................................................................................... 1
1.1 Overview ............................................................................................................ 1

1.1.1 Intended Use.............................................................................................. 1
1.1.2 Front Panel................................................................................................. 2
1.1.3 Rear Panel.................................................................................................. 4
1.2 Parameters ........................................................................................................ 5
1.3 Structure ............................................................................................................ 5
1.3.1 Flow System .............................................................................................. 5
1.3.2 Electrical System....................................................................................... 5
1.3.3 Display........................................................................................................ 6
1.4 Accessories....................................................................................................... 7
1.5 Sample Volume ................................................................................................. 7
1.6 Reagent Volume for Single Sample ................................................................ 7
1.7 Test speed ......................................................................................................... 7
1.8 Storage............................................................................................................... 7
1.9 Accuracy............................................................................................................ 7
1.10 Precision............................................................................................................ 8
1.11 Linearity ............................................................................................................. 8
1.12 Transport and Storage Specifications ............................................................ 8
1.13 Environment Requirement............................................................................... 8
1.14 Electrical Requirement..................................................................................... 9
1.15 Reagent.............................................................................................................. 9
1.15.1 Diluent ........................................................................................................ 9
1.15.2 Lyse ............................................................................................................ 9
1.15.3 Detergent.................................................................................................. 10
1.15.4 Probe Detergent ...................................................................................... 10
Chapter 2 Principles of Operation............................................................................11
2.1 Principles of Operation ...................................................................................11

2.1.1 Electrical Impedance Method..................................................................11
2.1.2 Colorimetric Method ............................................................................... 12
2.2 Calculation of Parameters ............................................................................. 12
Chapter 3 Installation and Specimen Analysis ...................................................... 14
3.1 Unpacking and Inspection ............................................................................. 14

3.2 Installation Requirements .............................................................................. 14
3.3 Power Supply Inspection ............................................................................... 15
3.4 Tubing Installation .......................................................................................... 15
3.4.1 LYSE Tubing Installation......................................................................... 16
I
Contents
3.4.2 DILUENT Tubing Installation .................................................................. 16

3.4.3 WASTE Tubing Installation..................................................................... 16
3.4.4 DETERGENT Tubing Installation ........................................................... 16
3.5 Printer Installation (optional) ......................................................................... 17
3.6 Keyboard and Mouse Installation ................................................................. 17
3.7 Power Connection .......................................................................................... 17
3.8 Startup.............................................................................................................. 18
3.9 Background Test............................................................................................. 18
3.10 Quality Control ................................................................................................ 19
3.11 Calibration ....................................................................................................... 19
3.12 Collection of Blood Sample ........................................................................... 19
3.12.1 Whole Blood Collection.......................................................................... 20
3.12.2 Capillary Blood Collection (Pre-diluent ) .............................................. 20
3.13 Whole Blood Mode and Pre-diluent Blood Mode ........................................ 20
3.14 Sample Counting and Analysis ..................................................................... 20
3.14.1 Information Input..................................................................................... 20
3.14.2 Counting and Analysis ........................................................................... 22
3.14.3 Special Function...................................................................................... 23
3.15 Result Analysis ............................................................................................... 24
3.16 Report Output.................................................................................................. 25
3.17 Result Modification......................................................................................... 25
3.18 Shutoff ............................................................................................................. 26
3.19 Data Review ..................................................................................................... 27
3.19.1 Data Review, Select and Print ................................................................ 28
3.19.2 Data Deletion ........................................................................................... 28
3.19.3 Workload Statistics ................................................................................. 29
Chapter 4 System Setting ........................................................................................ 31
4.1 System Maintenance ...................................................................................... 31

4.2 Transfer Setting............................................................................................... 32
4.3 Print Setting..................................................................................................... 33
4.4 Reference Value Setting................................................................................. 34
4.5 Time Setting .................................................................................................... 35
Chapter 5 Quality Control ........................................................................................ 36
5.1 Quality Control Options ................................................................................. 36

5.2 QC Operation................................................................................................... 37
5.2.1 L-J QC....................................................................................................... 37
5.2.2 X QC.......................................................................................................... 42
5.2.3 X-R QC...................................................................................................... 47
5.2.4 X-B QC...................................................................................................... 50
Chapter 6 Calibration................................................................................................ 56
6.1 Preparation for calibration ............................................................................. 58
I
Contents
6.2 Calibration Manually....................................................................................... 59

6.3 Calibration Automatically............................................................................... 60
Chapter 7 Parameter Limit ....................................................................................... 62
7.1 Limit Review .................................................................................................... 62

7.2 Limit Modification ........................................................................................... 63
7.3 Print.................................................................................................................. 64
Chapter 8 Maintenance............................................................................................. 65
8.1 Daily Maintenance........................................................................................... 65

8.2 Weekly Maintenance....................................................................................... 66
8.2.1 Surface Maintenance .............................................................................. 66
8.2.2 Monthly Maintenance.............................................................................. 66
8.3 System Maintenance ...................................................................................... 67
8.3.1 H.V Cautery .............................................................................................. 67
8.3.2 Flush......................................................................................................... 68
8.3.3 Prime ........................................................................................................ 68
8.3.4 Fill Lyse .................................................................................................... 68
8.3.5 Fill Diluent ................................................................................................ 69
8.3.6 Fill Detergent ........................................................................................... 69
8.3.7 Tubing Clean............................................................................................ 70
8.3.8 Prepare Shipping..................................................................................... 71
8.4 Maintenance before Shipping or Leave Unused for a Long Time ............. 71
Chapter 9 Troubleshooting ...................................................................................... 73
9.1 Troubleshooting Guidance ............................................................................ 73

9.2 Obtaining Technical Assistance .................................................................... 74
9.3 Troubleshooting.............................................................................................. 74
9.3.1 Faults related to reagents ...................................................................... 74
9.3.2 Fault related to Test Value ..................................................................... 75
9.3.3 Fault related to hardware ....................................................................... 77
Chapter 10 Precautions, Limitations and Hazards .................................................. 78
10.1 Limitations ....................................................................................................... 78

10.2 Location Limitations....................................................................................... 78
10.3 Safety and Infection Control.......................................................................... 79
Appendix 1: Instrument Icon and Symbols Specification ......................................... 81
II
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-3010 Automated
Hematology Analyzer, covering all the updated information before printing.
URIT Medical Electronic CO., LTD. is fully responsible for the revision and
explanation of the manual, and reserves the right to renovate the relevant
contents without separate notification. Some of the demonstration pictures are
for reference and subject to real object if any differences.
All the information included is protected by copyright. No part of this document

may be reproduced, stored or transmitted in any form or by any means unless
written authorization by URIT Medical Electronic CO., LTD.
All instructions must be followed strictly in operation. In no event should URIT

Medical Electronic CO., LTD be responsible for failures, errors and other
liabilities resulting from user's noncompliance with the procedures and
precautions outlined herein.
Limited Responsibility for Quality Warranty:

The manual for URIT-3010 Automated Hematology Analyzer, defines the
rights and obligations between the URIT and the customers about the
responsibility for quality warranty and after-sale service, also the related
agreements on commencement and termination.
URIT warrants the URIT-3010 sold by the URIT and its authorized agents to be
free from defects in workmanship and materials during normal use by the
original purchaser. This warranty shall continue for a period of one year since
the date of installation. The instrument life is ten years.
URIT assumes no liability in the following situations even during the period of
I
Copyright and Declaration
warranty:
a) Failure due to abuse the instrument or neglect the maintenance.
b) Use reagents and accessories other than manufactured or
recommended by URIT.
c) Failure due to operation not under the instructions described in the
manual.
d) Replace accessories not specified by URIT, or after maintenance or
repair by a service agent not approved or authorized by URIT.
CAUTION:
THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE
ONLY.
Technical service and troubleshooting are provided by the Service Department

of URIT. Professional technician and sale representative will be sent to offer
you timely service when necessary.
URIT Medical Electronic Co., Ltd.

No.07 D, High-Tech Area Information Industry Garden, Guilin,
Guangxi, China
Tel: +86（773）2832799 2821086
Fax: +86（773）2804668
Website: www.urit.com
E-mail: service@uritest.com
Wellkang Ltd t/a Wellkang Tech Consulting

Suite B 29 Harley Street, LONDON W1G 9QR, UK
Version : V1.00
I
Guidance
General information for the operation of the analyzer is contained in this

manual, which covers the best guidance for a new operator to master the
characteristics of the analyzer and operation methods, as well as for daily
inquiry. Do peruse before first operation.
This manual uses the following warning conventions:

WARNING: Denotes a hazard which, if not avoided, could result in
moderate to serious injury.
CAUTION: Denotes potential hazards that could result in a minor injury,
also used for conditions or activities which could interfere
with proper function of the analyzer.
NOTE: Denotes special operator/service information or standard
practices.
Do read through this manual before operation, maintenance,

displacement to the analyzer.
URIT Medical Electronic Co., Ltd. is abbreviated as URIT.
III
Chapter 1 System Description
1.1 Overview
The URIT-3010 is a multi-parameter, automated hematology analyzer

designed for in vitro diagnostic use in clinical laboratories, to analyze the
human blood cells and displays 19 parameters and 3 histograms.
1.1.1 Intended Use
The URIT-3010 generates the following 19 hematologic measurements on

EDTA-anticoagulated human blood:
Table 1-1 19 Parameters

Abbreviation Full Name Unit
9
WBC White Blood Cell Count 10 cells/L
LYM% Lymphocyte Percent %
MID% Monocyte Percent %
GRAN% Granulocyte Percent %
LYM# Lymphocyte Count 109cells/L
MID# Monocyte Count 109cells/L
GRAN# Granulocyte Count 109cells/L
RBC Red Blood Cell Count 1012cells/L
HGB Hemoglobin Concentration g/L（or g/dL）
HCT Hematocrit (relative volume of erythrocytes) %
MCV Mean Corpuscular Volume fL
MCH Mean Corpuscular Hemoglobin pg
MCHC Mean Corpuscular Hemoglobin Concentration g/L（or g/dL）
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 %
1
System Description
1.1.2 Front Panel
1 5
7
6
3
4 2
Figure 1-1 Front Panel

1. Status Indicator
The status indicator lights after power on the analyzer.
Indicator in Green: Donates that the analyzer is ready to run a sample.
Indicator in Orange: Donates that the analyzer is busy, wait for the green
indicator to process another sample.
2. Aspiration Probe
Aspirate samples.
3. RUN Key
press the RUN key to startup the count analysis only in the interfaces of
Hematology Analyzer and Quality Control. In other interface, the RUN key
is invalid.
4. Recorder
Print the test result from this inner thermal recorder.
5. Work Mode Indicator
The light indicator means whole blood mode, and dark indicator means
pre-diluent mode.
6. Display: 10.4-inch LCD with a resolution of 640 × 480. The screen is
divided into 5 areas as showing in figure 1-2:
2
System Description
System Information Mode System Time
Result Display
Menu
Figure 1-2 Screen
 System Information
Display the system information.
 Mode
Display the work mode: whole blood mode or pre-diluent mode.
 System Time
Display the system date and time.
 Result Display
Display the test result.
 Menu
Display functional menus which fall into two categories.
First category (from left to right) as the bottom line of figure 1-3:
Figure 1-3 Hematology Analyzer Interface
2
System Description
Func: Directs to second category menu.

Info: Directs to next specimen’s information-input window.
Rev: Directs to review stored specimens data.
Histo: Directs to histogram-modification window of the current specimen.
Drain: Dispels the diluent from the aspiration probe, mainly used for the
pre-dilution of capillary blood.
Trans: Transmits specimen data to the network.
Print: Print the specimen data.
Mute: Stops the alarm.
Help: Directs to system help window.
Exit: Click Exit, “Thank you, now turn off power” will appear to instruct the
operator to turn off the power switch on the rear panel.
Second category (from left to right) as figure 1-4:
Figure 1-4 Functional Menus
Back: Returns to the first category.

Maintain: Directs to Maintain window to perform operations of flush, prime,
cautery, etc.
Limit: Directs to limit-setting window to modify the limits of parameters.
Statistics: Calculate the workload of doctor or department during a certain
time.
QC: Directs to quality-control window to process QC.
Cal: Directs to calibration window to calibrate the analyzer.
Setup: Directs to setup window to reset some parameters
Service: Directs to service window to process self-check and maintenance.
Help: Directs to system help window.
License: Manage the period of validity after replacing diluent.
7. Shortcut Key
Mode: Switch between whole blood mode and pre-diluent mode.
Prime: Start the prime program to clean the measurement units.
Flush: Eliminate micro-aperture clog.
Drain: Dispel the diluent from the aspiration probe, mainly used for the
pre-dilution of capillary blood.
Print: Print the test result.
3
System Description
1.1.3 Rear Panel
4
3
13
5
9
6
12
10 7
11 8
Figure 1-5 Rear Panel
1、COM
Communication port connecting to the standard RS-232 network.
2、PRINTER 1, PRINTER2
Connect to the printers. PRINTER 1 is USB port，PRINTER2 is parallel port.
3、USB port
Connect to the USB equipment.
4、PS2 port
Connect to the keyboard and mouse.
5、Grounding Terminal
It’s used to ground the analyzer.
6、Fan
Fan cools the internal components of the analyzer.
7、Power Receptacle
Connect to the main power cord to the analyzer.
8、Power Switch
Turn the power supply on or off.
9、Waste SENSOR
Waste sensor port connects to the waste sensor.
10、DETERGENT
Detergent port connects to the detergent inlet tube.
4
System Description
11、WASTE
Waste port connects to the waste outlet tube.
12、LYSE
Lyse port connects to the lyse inlet tube.
13、DILUENT
Diluent port connects to the diluent inlet tube.
1.2 Parameters
The analyzer automatically analyses the sample data, differentiates the white
blood cells into three subpopulations and displays 19 parameters and 3
histograms of WBC, RBC and PLT. Refer to table 1-1 for details of 19
parameters.
1.3 Structure
The analyzer consists of flow system, electrical system, display, etc.
1.3.1 Flow System
The flow system is composed of solenoid valves, vacuum pump, force pump,
vacuum chamber and plastic tube.
Solenoid Valve--- These contact two-way or three-way solenoid valves control

the flow of reagent.
Vacuum Pump --- Pump the waste generated in the processing out to the
analyzer, and produce negative pressure.
Force Pump --- Provide positive pressure for reverse clean and lyse mixture.
Vacuum Chamber--- Generate negative pressure and play the role of temporary
waste reservoir.
Plastic Tube --- Reagent and waste flow in the plastic tube.
1.3.2 Electrical System
1.3.2.1 A/D and Mainboard
Mainboard is the control center of the analyzer; it controls the following

components and their movement:
 All the valves open and close, reagent aspiration, rinse and waste
discharge.
 Run force pump and vacuum pump to offer power to mix reagent, eliminate
clogs, aspirate and discharge reagents.
 Control step motors to aspirate sample and reagent.
 Control the A/D conversion of WBC, RBC/PLT and HGB; provide previous
5
System Description
service for the computer’s data processing.

 Check all the optical and electrical switch movements.
1.3.2.2 WBC Metering Assembly
WBC Metering Assembly is composed of signal collection board, electrodes,

micro-aperture sensor and flow system.
 Signal Collection Board --- It provides electrodes constant current, amplifies
and deals with the collected pulse signal for mainboard.
 Electrode --- There are two electrodes in WBC metering assembly, one
inner electrode located in WBC probe, and one outer electrode. Both
electrodes are submerged in the conductive liquid, creating an electrical
pathway through the micro-aperture.
 Micro-aperture Sensor --- Micro-aperture sensor is mounted on the front
end of WBC probe. The particles in sample pass through this aperture
which diameter is 100μm when processing a sample.
 Flow System --- The flow system uses negative pressure to aspirate diluent,
detergent and sample from each container into metering tube, and
discharge waste at the end of the processing. The step motor controlled by
mainboard runs to add specific volume lyse into WBC cup, and mix it by the
air created by force pump.
1.3.2.3 RBC/PLT Metering Assembly
RBC/PLT Metering Assembly is composed of signal collection board, electrodes,

micro-aperture sensor and flow system.
 Signal Collection Board --- It provides electrodes constant current, amplifies
and deals with the collected pulse signal for mainboard.
 Electrode --- There are two electrodes in RBC/PLT metering assembly, one
inner electrode located in RBC/PLT probe, and one outer electrode. Both
electrodes are submerged in the conductive liquid, creating an electrical
pathway through the micro-aperture.
 Micro-aperture Sensor --- Micro-aperture sensor is mounted on the front
end of RBC/PLT probe. The particles in sample pass through this aperture
which diameter is 80μm when processing a sample.
 Flow System --- The flow system uses negative pressure to aspirate diluent,
detergent and sample from each container into metering tube, and
discharge waste at the end of the processing.
1.3.3 Display
URIT-3010 uses a 10.4-inch LCD with a resolution of 640 × 480 which displays
19 parameters and 3 histograms.
6
System Description
1.4 Accessories
The accessories of the analyzer include power cord, grounding cord, printer
(optional), etc., and printer should be supplied or authorized by URIT.
1.5 Sample Volume
Whole Blood Mode: Whole Blood 10 μL

Pre-diluent Mode: Capillary Blood 20 μL
1.6 Reagent Volume for Single Sample
Diluent: 31mL
Detergent: 8mL
Lyse: 0.7mL
Reagent consuming will change with instrument version.
1.7 Test speed
URIT-3010 is able to process 60 samples per hour.
1.8 Storage
URIT-3010 contains a memorizer which can store 25,000 samples data.
1.9 Accuracy
The accuracy of analyzer should be complied with table 1-2.
Table 1-2 Accuracy

Parameter Acceptable Limits（%）
WBC ≤±2.0%
RBC ≤±1.5%
HGB ≤±1.5%
MCV ≤±0.5%
HCT ≤±2.0%
PLT ≤±4.0%
7
System Description
1.10 Precision
The precision of analyzer should be complied with table 1-3.
Table 1-3 Precision

Parameter Acceptable Limits（CV/%） Precision Range
WBC ≤2.0% 4.0×109/L ~ 15.0×109/L
RBC ≤1.5% 3.00×1012/L ~6.00×1012/L
HGB ≤1.5% 110 g/L ~180g/L
HCT ≤2.0% 35%~50%
MCV ≤0.5% 80fL ~110fL
PLT ≤4.0% 100×109/L ~500×109/L
1.11 Linearity
The linearity of analyzer should be conformed to table 1-4.
Table 1-4 Linearity

Parameter Linearity Range Acceptable Limits
9
0×10 /L~10.0×10 /L 9
≤±0.3×109/L
WBC
10.1×109/L ~99.9×109/L ≤±5%
12
0×10 /L ~1.00×10 /L 12
≤±0.05×1012/ L
RBC
1.01×1012/L ~9.99×1012/L ≤±5%
0 g/L ~70 g/L ≤±2g/L
HGB
71 g/L ~300 g/L ≤±2%
9
0×10 /L ~100×10 /L 9
≤±10×109/L
PLT
101×109/L ~999×109/L ≤±10%
1.12 Transport and Storage Specifications
a) Temperature: -10℃~55℃
b) Relative Humidity: ≤95%RH
c) Barometric: 75kPa~106kPa
1.13 Environment Requirement
a) Temperature: 18℃~35℃
b) Relative Humidity: ≤85%RH
c) Barometric: 80kPa~106kPa
8
System Description
1.14 Electrical Requirement
Power Supply: AC 100V～240V

Frequency: 50/60Hz
Power: 180 VA
Fuse: 250V/3A
1.15 Reagent
The reagent is formulated specifically for the URIT-3010 flow systems in order to
provide optimal system performance. Use of reagents other than those specified
in this manual is not recommended as analyzer performance can be affected.
Each URIT-3010 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 of the analyzer and serious
mistakes, even accidents.
Reagents must be stored at room temperature to ensure optimal performance.

All reagents should be protected form direct sunlight, extreme heat, and freezing
during storage. Temperatures below 0 ℃ may cause reagent layering that
changes the tonicity and conductivity of the reagents.
The reagent inlet tubes have a cap attached that minimizes evaporation and
contamination during use. However, reagent quality may deteriorate with time.
Therefore, use all reagents within the dating period.
1.15.1 Diluent
Diluent is a kind of reliable isotonic diluent to meet the requirements as follows:

a) Dilute WBC, RBC, PLT, HGB.
b) Keep the shape of cells during test process.
c) Offer appropriate background value.
d) Clean WBC and RBC micro-aperture and tubes.
1.15.2 Lyse
Lyse is a new reagent without NaN3 complex and cyanide and meets the
requirements as follows:
a) Dissolve RBC instantly with minimum ground substance complex.
b) Transform the membrane of the WBC to diffuse the cytoplasm, and
then WBC shrinks making membrane-bound nucleus. As a result,
WBC is present in granular shape.
c) Transform the hemoglobin to the hemo-compound which is suitable for
the measurement in the condition of 540nm wavelength.
9
System Description
d) Avoid scyanide’s serious pollution to the human body and the

environment.
1.15.3 Detergent
Detergent contains the active enzyme to clean the agglomerated protein in the
WBC, RBC probes and measurement circuit.
1.15.4 Probe Detergent
Probe detergent contains effective oxide to dredge the stubbornly-blocked

apertures on the WBC, RBC probes.
10
Chapter 2 Principles of Operation
The principles of operation of URIT-3010 automated hematology analyzer will

be discussed in this chapter. The two independent measurement methods
used in the analyzer are:
1) The electrical impedance method for determining the quantity and volume of
blood cell.
2) The colorimetric method for determining the content of hemoglobin.
2.1 Principles of Operation
The measurement is mainly on the quantity, volume of blood cells and HGB.
2.1.1 Electrical Impedance Method
The cells are counted and sized by the electrical impedance method. As Figure
2-1 shows, this method is based on the measurement of changes in electrical
current which are produced by a particle, suspended in a conductive liquid, as
it passes through an aperture of known dimensions. An electrode is
submerged in the liquid on either side of the aperture in order to create an
electrical pathway through it.
As each particle passes through the aperture, a transitory change in the

resistance between the electrodes is produced. This change produces a
measurable electrical pulse. The number of pulses generated is indicative of
the number of particles that traversed the aperture. The amplitude of each
pulse is essentially proportional to the volume of the particle that produced it.
Each pulse is amplified and compared to internal reference voltage channels.

These channels are delineated by calibrated size discriminators to accept only
pulses of certain amplitude. Thus, the pulses are sorted into various size
channels according to their amplitude.
11
Principles of Operation
Figure 2-1
The size channels are basically divided into three categories by a pre-set
classification program in the analyzer as follows:
WBC 35—450 fL
RBC 30—110 fL
PLT 2—30 fL
According to the volume, WBCs handled by lyse can be subdivided into three
Categories: Lymphocyte (LYM), Monocyte (MID) and Granulocyte (GRAN).
LYM 35—98 fL
MID 99—135 fL
GRAN 136—450 fL
2.1.2 Colorimetric Method
Lyse added into the blood sample will crack the membrane of red blood cells
promptly and transfer into a kind of compound which can absorb the
wavelength of 540 nm. Through the comparison of the absorbance between
the pure diluent and the sample, the concentration of sample hemoglobin is
calculated.
2.2 Calculation of Parameters
All the 19 parameters of blood sample are expressed in three ways:

1) parameters generated by analyzer directly: WBC，RBC，PLT，HGB ，MCV
12
Principles of Operation
2) parameters generated by histograms: LYM%，MID%，GRAN%，HCT，RDW，

MPV，PDW
3) parameters derived from certain formulas: LYM#，MID#，GRAN#，MCH，
MCHC，PCT
The formulas are as follows:
 HCT（%）= RBC×MCV/10
 MCH（pg）= HGB/RBC
 MCHC（g/L）= 100×HGB/HCT
 PCT（%）=PLT×MPV/10000
 LYM（%）= 100×AL /（AL+AM+AG）
 MID （%）= 100×AM /（AL+AM+AG）
 GRAN（%）= 100×AG/（AL+AM+AG）
WBC histogram is as figure 2-2.
Figure 2-2
AL: quantity of cells in area of LYM

AM: quantity of cells in area of MID
AG: quantity of cells in area of GRAN
The calculation formulas for absolute value of lymphocyte (LYM#),

monocyte(MID#) and granulocyte(GRAN#) are as follows:
 Lymphocyte（109L） LYM# = LYM%×WBC/100

 Monocyte（109L） MID# = MID%× WBC/100
 Granulocyte（109L） GRAN# = GRAN%×WBC /100
 RBC Distribution Width Repeat Precision（RDW-CV）is derived from
RBC histogram ， shows the volume distribution differentiation
coefficient of RBC, with the unit of %。
 RBC Distribution Width Standard Difference (RDW-SD) is derived from
RBC histogram，shows the volume distribution standard difference of
RBC, with the unit of fL.
 Platelet Distribution Width (PDW) is derived from PLT histogram，
shows the volume distribution of PLT.
13
Chapter 3 Installation and Specimen Analysis
Initial installation of analyzer must be performed by a URIT authorized

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

URIT could result in damage to the analyzer which is exclusive of the warranty.
Never attempt to install and operate the analyzer without a URIT authorized
representative.
3.1 Unpacking and Inspection
Carefully remove the analyzer and accessories from shipping carton, keep the
kit stored for further transport or storage. Check the following:
a) Quantity of accessories according to the packing list.

b) Leakage or soakage.
c) Mechanical damage.
d) Bare lead, inserts and accessories.
Do contact URIT Customer Support Center if any problem occurs.
3.2 Installation Requirements
Please refer to section 10.2 of chapter 10.

WARNING: Not for home use.
WARNING: Not for therapy.
WARNING: The Power switch is used as disconnect device, the
disconnect device shall remain readily operable. Please do not place the
instrument in the location where difficult to operate the disconnect device.
14
Installation and Specimen Analysis
CAUTION: Away from direct sunlight.

CAUTION: Avoid temperature extreme.
CAUTION: Away from centrifuge, X-ray equipment, display or copier.
CAUTION: No cell phone, wireless phone and equipments with strong
radiation which will interfere with the normal operation of the analyzer.
3.3 Power Supply Inspection
Be sure that the system is located at the desired site before attempting any
connections. See Table 3-1 for details.
Table 3-1
Optimal Voltage Voltage Range Frequency
AC220V AC（100—240）V （50—60 ）Hz
WARNING: A grounded power outlet is required to connect directly with the

grounding terminal on the rear panel. Be sure to guarantee the security of the
work site.
CAUTION: A fluctuated voltage would impair performance and reliability of the
analyzer. Proper action such as the installation of E.C manostat (not provided
by URIT) should be taken before operation.
CAUTION: Frequent power failure will seriously decrease the performance and
reliability of the analyzer. Proper action such as the installation of UPS (not
provided by URIT) should be taken before operation.
3.4 Tubing Installation
There are four tube-connectors on the rear panel: LYSE, DILUENT,

DETERGENT and WASTE, each of which is wrapped with a cap to avoid
contamination by the URIT before shipment. Uncover and set the caps aside
carefully for further use on initial installation.
15
3.4.1 LYSE Tubing Installation
Remove the lyse tube with red faucet from reagent kit and attach it to LYSE
connector on the rear panel, place the other end into the lyse container. Twist
the cap until secure. Place the container on the same level as the analyzer.
3.4.2 DILUENT Tubing Installation
Remove the diluent tube with blue faucet from reagent kit and attach it to
DILUENT connector on the rear panel. Place the other end into the diluent
container. Twist the cap until secure. Place the container on the same level as
the analyzer.
3.4.3 WASTE Tubing Installation
Remove the waste tube with black faucet from reagent kit and attach it to
WASTE connector on the rear panel, connect BNC plug with the socket
marked “SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the
waste container until secure. Place the container on the level at least 50cm
lower than the analyzer.
3.4.4 DETERGENT Tubing Installation
Remove the detergent tube with yellow faucet from reagent kit and attach it to
DETERGENT connector on the rear panel. Place the other end into the
detergent container. Twist the cap until secure. Place the container on the
same level as the analyzer.
CAUTION: keep the tube in loose condition after installation, no distortion or

folding.
CAUTION: All the tubes should be installed manually. Do NOT utilize any tool.
CAUTION: If any damage or leakage occurs in the reagent container, or the
reagents have exceeded expiry date, contacts URIT Customer Support Centre
for replacement.
16
WARNNING: The waste must be handled with biochemical or chemical

methods before disposal, or it will cause contamination to the environment.
Users have obligation to follow the local and national environmental
regulations.
3.5 Printer Installation (optional)
Take out the printer from the shipping carton. Inspect the printer carefully
according to its manual and Section 3.1 and perform the following procedures:
a) Find a suitable location adjacent to the analyzer. Location of at least 30cm
away from analyzer on its right side is recommended.
b) Assemble the printer as directed in the printer manual.
c) Connect the printer and analyzer with printer cable which plug into
PRINTER1 or PRINTER2 on rear panel of the analyzer according to the
type of printer.
d) Be sure that the printer power switch is OFF; plug one end of power cord to
power socket.
e) Install printing paper as directed in the manual.
3.6 Keyboard and Mouse Installation
Remove keyboard, mouse and mouse pad from the shipping carton, and insert
the plugs of keyboard and mouse into the two connector of the line, then
connect to the rear panel with “KEYBOARD”. It is recommended to place the
keyboard beneath the display.
3.7 Power Connection
Make sure the power switch is OFF (O) and the grounding terminal on the rear
panel is well grounded firstly, then connect the analyzer to the main power with
the power cable.
17
3.8 Startup
Turn on the power switch on the rear panel, then the status indicator on the
front panel will be in orange. The analyzer will start self-checking after loading,
and automatically aspirate the diluent and lyse reagent, then rinse the tubing.
The Hematology Analyzer interface appears after self-checking (See Figure
1-3).
3.9 Background Test
Background test should be performed after startup and before blood sample
test, the procedures are as follows:
a) Put the clean empty tube under the aspiration probe. At Hematology
Analyzer interface, click Drain to dispense the diluent into the tube.
b) At Hematology Analyzer, click Info, and then modify ID to 0, click OK
back to Hematology Analyzer.
c) Put the tube containing diluent beneath aspiration probe which
should touch the bottom of tube.
d) Press RUN key on the front panel, move away the tube after “Di”
sound. Then the analyzer starts to count and measure automatically.
e) The counting time of RBC, WBC will be displayed at the lower right
corner of screen during counting. The alarm rings when the counting
time is too long or too short. Refer to Chapter 9 for problem
correction.
f) The acceptable range of background is listed in table 3-2.
Table 3-2 Acceptable Range of Background
Parameter Acceptable Range
WBC ≤0.2x109/L
RBC ≤0.02x1012/L
HGB ≤1g/L
PLT ≤10x109/L
18
If the background result is out of acceptable range, repeat the above

procedures until reach the acceptable results.
NOTE: ID number of background test is set to be 0 by the software to

make the result not memorized in the analyzer.
NOTE: The ID number of blood sample test can NOT be set to 0.
3.10 Quality Control

Quality control should be performed before daily test or on the initial installation.
Refer to Chapter 5.
3.11 Calibration
URIT calibrates the analyzer in factory before shipment. On the initial
installation, if the background results and quality control are normal,
recalibration is not necessary. If not and there are shifts or trends in some
parameters, recalibrate the analyzer referring to Chapter 6.
3.12 Collection of Blood Sample
CAUTION: Consider all the clinical specimens, controls and calibrators etc that
contain human blood or serum as being potentially infectious, wear lab coats,
gloves and safety glasses and follow required laboratory or clinical procedures
when handling these materials.
CAUTION: Blood collection and disposal should be performed according to the
local and national environmental regulations or laboratory’s requirements.
CAUTION: Be sure the blood collection clean and contamination-free. All
specimens must be properly collected in tubes containing the
EDTA(EDTA-K2·2H2O) anticoagulant used by the laboratory.
CAUTION: Do not shake the sample tube violently.
NOTE: Venous blood can only be stored for 4 hours at room temperature.
URIT recommends the blood sample be kept at temperature between 2-8℃ for
longer storage
19
3.12.1 Whole Blood Collection
Collecting whole blood sample through vein-puncture and store in a clean

sample tube with EDTA-K2·2H2O, which can keep the configuration of WBC,
RBC and avoid platelets aggregation. Gently shake the tube 5~10 times to
make it well mixed.
3.12.2 Capillary Blood Collection (Pre-diluent )
Capillary blood is usually collected from finger tip. The volume of sample tube
is set to be 20ul.
CAUTION: Never over-press the finger avoiding collecting tissue liquid into
sample tube, tissue liquid will cause error in results.
3.13 Whole Blood Mode and Pre-diluent Blood Mode
Whole blood mode switch to pre-diluent mode: In figure 1-1, click will
switch to pre-diluent mode, the sign on screen will turn to
simultaneously.
Method of switching “pre-diluent mode” to “whole blood mode” is the same.
3.14 Sample Counting and Analysis
Sample counting and analysis is processed as following procedures.
3.14.1 Information Input
■ Input information manually

Click Info at Hematology Analyzer, the Info edit window present (shown in
figure 3-1), input or select data. Click OK to save the input data and return to
Hematology Analyzer. Click Cancel to cancel the input data and return to
Hematology Analyzer.
20
Figure 3-1
Name: Input letter or number.

Sex: Select male or female. If not selected, default as blank.
Age: Input Year, Month and Day.
Blood: Select A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-.
O Rh+, O Rh-. If not selected, default as blank.
Limit: Select Auto, Man, Woman, Child, Baby, General, User 1, User 2,
User 3. If Auto is selected, the reference values are listed as Table 3-3.
Table 3-3 Reference Value
Reference value Age (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 00000000-99999999. If no ID input, the

ID of current sample will be automatically added follow the last one.
Sample No.: Input the sample number.
Bed No.: Input bed No. of patient.
Dept.: Input department name or code of operator.
21
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 test. The blood
sample ID CAN NOT be 0.
3.14.2 Counting and Analysis
Counting and analysis should be performed within 3~5 minutes after blood
collection.
■ Pre-diluent Mode
a) Present the empty sample tube under the aspiration probe. At

Hematology Analyzer, click Drain; the diluent will be dispensed into
the tube.
b) Remove the tube, add 20ul of the blood sample to the tube, and
gently shake the tube to make them well mixed.
c) Present the well-mixed sample under the aspiration probe; make
sure the probe touches the tube bottom slightly.
d) Press RUN key on the front panel and remove the sample after
hearing Di sound.
e) The results will be available after the analysis is performed.
■ Whole Blood Mode
a) Gently shake the tube to well mix the blood sample, then present
the sample tube beneath the probe, make sure the probe touches
tube bottom slightly.
b) Press RUN key and remove the sample after hearing Di sound.
c) The results will be available after the analysis is performed.
The test results and histograms of WBC, RBC and PLT will be displayed at
Hematology Analyzer window after counting and analysis (see figure 1-1).
If Auto Rec or Auto Print is ON, the test results will be print automatically.
22
If problems like clogs or bubbles occur during the counting and analysis
procedures, the alarm rings and indication are given on the screen, the test
results are invalid. Refer to Chapter 9 for solution.
3.14.3 Special Function
3.14.3.1 Recount
If problems like bubble, clog, diluent empty, lyse empty, detergent empty occur
during counting, the system will prompt whether or not to recount. Press NO to
exit the dialog box, and the current test result will be saved automatically. If
result is not unsatisfactory, press YES to recount he sample, and current result
will not be saved.
3.14.3.2 Parameter Alarm
There are parameter alarms and histogram alarms.

Parameter Alarm:
1. ”H” or “L” present on the right side of the parameter means the result is
out of the range of reference value.
2. “***” means the result is invalid or out of display range.
3.14.3.3 Histogram Alarm
1. WBC Histogram Alarm

If the WBC Histogram is abnormal, R1, R2, R3, R4, RM will display on
the right side of the histogram.
 R1 indicates there is abnormality in the left side of LY wave peak,
which probably caused by platelet clump, giant platelet, nucleated
RBC, resistance RBC, proteinic and fat granule, or electrical noise.
 R2 indicates there is abnormality in the area between LY wave
peak and MO wave, which probably caused by pathologic
lymphocyte, plasmocyte, atypia lymphocyte, an increase in original
cell or eosinophil, basophilia.
23
 R3 indicates there is abnormality in the area between MO wave

and GR wave peak, which probably caused by immature
granulocyte, abnormal cell subpopulation, eosinophilia.
 R4 indicates there is abnormality in the right side of GR wave peak,
which probably caused by an absolute increase in granulocyte.
 RM indicates there are two or more preceding alarms.
2. PLT Histogram Alarm
PM indicates there is ill-defined boundary between PLT and RBC,
which probably caused by the present of giant platelet, platelet clump,
small RBC, cell debris or fibrin.
3.15 Result Analysis
URIT-3010 provides plenty and convenient result analysis functions.

 Click Histo to modify the test results. Refer to Section 3.18 in this chapter
for details.
 Click Trans to transmit the data to network.
 Click Print to print data report of current blood sample by inner recorder or
outer printer.
 Click Mute to mute or sound the alarm.
 Click Help to get necessary help.
 ”H” or “L” present on the right side of the parameter means the result is out
of the range of reference value. “L” means result is lower than the lower
limit while “H” means result is higher than upper limit.
 If counting time lower than system setting lower limit, the system will alarm
“WBC bubble” or “RBC bubble”, at the same time display “B” before test
result.
 If counting time higher than system setting time, the system will alarm
“WBC clog” or “RBC clog”, at the same time display “C” before test result.
NOTE: Because of large display of limit sequence, it should be set “None” in

System Setting for limit sequence firstly, then “L”, “H”, “B”, “C” will appear.
24
NOTE: The parameter value is *** means invalid data.

NOTE: If there is PLT Histogram Alarm, the PDW probably is ***.
NOTE: WBC differentiation may be incorrect if WBC is lower than 0.5 x109 /L.
Microscope examination is recommended.
3.16 Report Output
URIT-3010 offers inner thermal recorder and outer printer which are optional
according to customer needs. After blood sample analysis completed, if Auto
Rec is ON, test report will be printed automatically by inner recorder or outer
printer; if the Auto Trans is ON, test results will be transmitted to network
automatically.
The recorder, printer, transmit and test reports are set up at Settings. Refer to
Chapter 4 for details.
Click Trans to transmit data of the current sample to network.

Click Print to print test report of current sample by inner recorder or outer
printer.
3.17 Result Modification
If the auto-classification of floating limit for WBC, RBC and PLT do not reach
clinical or laboratory requirements on special samples, manual classification is
feasible.
CAUTION: Unnecessary or incorrect manual classification will cause
unreliable test results. It is recommended to microscopic exam before manual
classification.
The procedures are as follows:

a) At Hematology Analyzer, click Histo to select histogram of WBC which is
surrounded by a rectangle of red line (see figure 3-2), and click the Param
icon below to select WBC, RBC, PLT diagram parameter that needs
25
modification.
Figure 3-2
b) Once the diagram parameter needed to modify is selected, click Class to

select the desired classification, then the classified line will change from
white line to red line.
c) Click Left or Right to move the classified line, and the value of classified line
will be indicated at the lower right of the screen.
d) Click Back after modification and appear the following figure 3-3, click NO to
cancel the modification, while click YES to save the modified results.
Figure 3-3
3.18 Shutoff
Shutoff procedure is performed after daily operation and before turning the
analyzer off. Daily maintenance and tubing-rinse avoid protein aggregation
26
during non-working and keep system clean. Shutoff procedure is as follows:

a) At Hematology Analyzer, click Exit, shutoff information will appear (See
Figure 3-4).
Figure 3-4
If turn off the instrument, click Yes. After finishing the maintenance, cleaning
and shutoff procedures, “Thank you, now turn off power” will appear to instruct
the operator to turn off the power switch on the rear panel.
b) Tidy the work platform and dispose waste.
c) Click No if the operator does not want to shutoff the analyzer.
NOTE: Wrong operations on shutoff procedure will decrease reliability

and performance of the analyzer, any problems derived from that will NOT
be guaranteed free by URIT.
CAUTION: May leads to data lose if turn off the analyzer against
procedures.
3.19 Data Review

The information, parameters and histograms of test results can be reviewed,
and also can be printed out by inner recorder or outer printer.
At Hematology Analyzer, click Review to enter query interface as figure 3-5.
27
Figure 3-5 Query
3.19.1 Data Review, Select and Print
Conditional Query: Query data compliant with specific criteria in certain period.
Select a data in the list, click Detail, the parameters result and histograms of
selected data will display.
Click Today, all test datum of intraday display in list.
If selected data is too large to display in one page, the system will display the
data in more pages. Click Pgpre or Pgnex to view the other information.
Click Print to print the selected data.
Click Print All to print all the data in current list by outer printer.
Click Count to print all the data saved in list by outer printer.
Click Back return to the Hematology Analyzer window.
3.19.2 Data Deletion
After processing plenty samples, it is necessary to clean up or delete the mass

data stored in the analyzer according to the requirement of user. There are two
28
methods to delete data.

（1）Delete All
Click Delete All in figure 3-5, a dialog box as figure 3-6 will present, input
password 9999 to delete all data. Click Cancel to back to Hematology Analyzer
window. Click OK to display a confirm dialog box, select No to cancel the
deletion, select Yes to delete all data.
Figure 3-6
（2）Single Delete
In figure 3-5, select data in the list, and click Del. to display a confirm dialog
box, select No to cancel the deletion, select Yes to delete the selected data.
NOTE: Be aware that the data once they are deleted can NOT be recovered,
please operate with caution.
3.19.3 Workload Statistics
At Hematology Analyzer, click “Func”→ “Statistics” to enter Workload statistics

window (See Figure 3-7). Operation procedure is as follows:
29
Figure 3-7
a) At “Form” and “To”, select starting date and ending date in pop-up
calendar, then press “OK”.
b) Select one statistic type on left side of the Workload Statistics interface,
and then display all items in the middle list box.
c) Select statistic item (or multi-select), click “Statistics”, then the desired
data will display in list on right.
d) Choose one sender, and click Print, then all the items will be print.
e) Click Back to return to Hematology Analyze interface.
30
Chapter 4 System Setting
URIT-3010 has options to satisfy the different requirements of laboratory and

clinical diagnostics. Operators can choose different operating modes
according to actual need.
At Hematology Analyzer, click Func, and then click Setup. The Setup menu will
display as Figure 4-1:
Figure 4-1
4.1 System Maintenance

Warning: Alarm the errors in analyzer.
Auto-Clean: The analyzer will rinse automatically in set time.
Auto-Blank: Select ON in Auto-Blank and click OK, the analyzer will run a
background test automatically when startup the analyzer each time.
Auto-Sleep: The analyzer will enter dormancy status if there is no operation in
31
System Setting
set-time.
Pre-diluent: If the Pre-diluent is ON, each time when operator runs a sample,
the system will prompt that whether or not to run the sample under pre-diluent
mode.
4.2 Transfer Setting
Figure 4-2
In transfer setting as figure 4-2, operator can setup the port number, baud rate,
data bit, stop bit and parity bit of the communication port. If the auto-trans is
ON, the test results will transmit from the communication port automatically.
NOTE: Transfer setting should be under the guidance of URIT engineer.
32
System Setting
4.3 Print Setting
Figure 4-3
In Print Setting as figure 4-3, operator can select printer type, print format, auto
print, and input hospital name in “print title”.
33
System Setting
4.4 Reference Value Setting
Figure 4-4
In Reference Value Setting as figure 4-4, operator can setup the unit of WBC,
RBC, PLT, HGB and MCHC, as well as the language and order of the
reference value.
34
System Setting
4.5 Time Setting
Figure 4-5
In Time Setting as figure 4-5, there are three formats of date: YYYY-MM-DD,
MM-DD-YYYY, and DD-MM-YYYY. Y indicates Year, M indicates Month, D
indicates Day. The selected date format will display on the system interface.
NOTE: The date format is properly set at the factory prior to shipping. As a rule,
there is no need to reset. Time setting should be under the guidance of URIT
engineer if it’s necessary.
35
Chapter 5 Quality Control
In order to maintain the analyzer precision and eliminate system errors, it’s
necessary to perform quality control. URIT-3010 offers four quality control
options: L-J QC, X-B QC, X-R QC and X QC. In following conditions, perform
quality control using URIT recommended control materials.
 After daily start-up procedures completed
 The reagent lot number changed
 After calibration
 After maintenance, or component replacement
 In accordance with the laboratory or clinical QC protocol
 In suspicion of parameter value
To ensure accuracy of the results, commercial controls must be handled as

follows:
 Make sure the controls stored at low temperature and without leakage.
 Mix the controls according to the manufacturer’s recommendations.
 Never use controls which are unsealed longer than the period
recommended by the manufacturer.
 Never subject controls to extreme heat or vibration.
 Perform the high, normal and low controls of new lot, and compare the
values with last lot to verify the difference.
CAUTION: Consider all 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.
5.1 Quality Control Options
(1) L-J QC
L-J QC (Levey-Jennings graph) is a simple and visual QC method with which
36
Quality Control
operator can draw QC value directly on graph after get the Mean, SD and CV.
Mean, SD and CV are derived from following formulas:
n
X i
Mean  i 1
SD 
(X i  Mean) 2
n 1
SD
CV %   100
Mean
(2) X-R QC
In X-R QC method, X indicates mean value, R indicates range of value. X
graph is mainly used to judge that if the mean value falls in required level. R
graph is mainly used to judge that if the range of value falls in required level.
(3) X QC
X QC is the variation of X-R QC; they have the same basic principle. The
difference is that the control dot in X graph indicates the mean value of two
values other than one value. On this foundation, calculate the Mean, SD and
CV.
(4) X-B QC
X-B QC is a moving average method which is first promoted in 1970s’. It’s
based on the principle that, RBC count is varied due to the concentration of
dilution, human blood pathology and technical factor, but the hemoglobin
content in specific unit is hardly interfered by those preceding factors.
According to this characteristic, quality control the samples by surveying the
value of MCV, MCH, and MCHC.
5.2 QC Operation
5.2.1 L-J QC
Click QC in main interface, dialog box like figure 5-1 will present.
37
Quality Control
Figure 5-1
URIT-3010 offers four quality control options: L-J QC, X-B QC, X-R QC and X
QC. Select L-J QC mode and click OK to enter corresponding interface like
figure 5-2.
Figure 5-2
5.2.1.1 QC Edit
In L-J QC interface click Edit, enter QC Edit interface as figure 5-3. There are 3
different groups of control and each group has 3 (low, normal and high) levels.
38
Quality Control
Input control lot No., expiry date, assay and limit according to the control
instruction.
NOTE: The limit should not be more than 40% of assay, or the limit cannot be
saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.
Figure 5-3
5.2.1.2 QC Run
In L-J QC interface click Run, enter QC Run interface as figure 5-4.
In QC Run interface, place the control tube under aspiration probe, press RUN
key, the analyzer will start to process control sample. If the current group assay
is empty, the system will display “No QC reference data, can not perform QC
running”. At this time, operator should back to the Edit interface to input assay
and limit.
39
Quality Control
L-J QC needs control material. If run a background QC, the system will alarm
QC result is invalid.
Each time run a QC, the Run Time on the upper right corner of the Run
interface will be updated correspondingly. The lot No. and expiry date are input
in Edit interface.
Figure 5-4
5.2.1.3 L-J QC Review
There are two ways to review.

(1) QC Graph
Click Back in QC Run interface or select corresponding QC mode in QC Mode
dialog box, enter the L-J QC interface as figure 5-2 in where operator can
review 12 parameters QC results.
In L-J QC interface, there are low, normal and high graphs. If select group 1
and level low to run a control sample, the control dot will present in low 1 graph.
The other selection will present in corresponding graph.
40
Quality Control
There are function buttons at the bottom of L-J QC interface. Click Group to
change the group. Click Parameter to change current display parameter, for
instance, WBC changes to RBC. Click Level to shift the classification line in the
same group. Click Left or Right to shift the classification line in same QC graph.
Click Print to print the current data.
QC results are arranged in graphs according to storage time. The latest is on

the left side and its serial number is 1.
QC graph instruction:
1、 Graph abscissa indicates QC run times, ordinate indicates QC result.
2、 Every parameter graph may display 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 plus limit
 middle line —— assay
 lower limit —— assay subtract limit
If the control dot falls in the area between upper and lower lines of the
corresponding graph, it means the dot under control range; if it’s out of the
above area, the dot is not under control range.
(2) QC Data
In figure 5-2, click Data, operator can review 12 parameters QC data as figure
5-5.
41
Quality Control
Figure 5-5
In this interface, click Group to change group, click left or right to view next
page. Operator could review 31 items data at most. Click Delete All to delete all
the data.
The assay and limit are input and changed in QC Edit.
The QC data would be updated after running a new control.
5.2.2 X QC
5.2.2.1 X QC Edit
Select X QC mode in figure 5-1 and click OK to enter corresponding interface.

Click Edit, enter X QC Edit interface as figure 5-6.
42
Quality Control
Figure 5-6
In X QC Edit interface, click Group to switch group; click Delete to delete the
current assay and limit; click OK to save the current assay and limit; click Back
to exit X QC Edit interface.
saved in database.
NOTE: The expiry date format should be MM-DD-YYYY.
5.2.2.2 X QC Run
In X QC interface click Run, enter QC Run interface as figure 5-7.

In this interface, system displays two controls result and calculates the mean
value automatically. The assay is input in X QC Edit interface. Click Group to
switch group; click Back to exit.
43
Quality Control
Figure 5-7
In QC Run interface, place the control tube under aspiration probe, press RUN
key, the analyzer will start to process control sample. If the current group assay
is empty, the system will display “No QC reference data, can not perform QC
running”. At this time, operator should back to the Edit interface to input assay
and limit.
X QC needs control material. If run a background QC, the system will alarm
QC result is invalid.
5.2.2.3 X QC Review
There are two ways to review.

(1) QC Graph
dialog box, enter the X QC interface as figure 5-8 in where operator can review
12 parameters QC results. As a difference to L-J QC Graph, the dot on X QC
Graph indicates mean value of two QC results.
44
Quality Control
Figure 5-8
In X QC interface, there are low, normal and high graphs. If select group 1 and
level low to run a control sample, the control dot will present in low 1 graph.
The other selection will present in corresponding graph.
There are function buttons at the bottom of X QC interface. Click Group to

instance, WBC changes to RBC. Click Level to shift the classification line in the
same group. Click Left or Right to shift the classification line in same QC graph.
Click Print to print the current data.

QC graph instruction:
45
Quality Control
limit.
(2) QC Data
5-9.
the data.
The assay and limit are input and changed in QC Edit.
The QC data would be updated after running two new controls and display the
mean value.
Figure 5-9
46
Quality Control
5.2.3 X-R QC
5.2.3.1 X-R QC Run
In X-R QC interface click Run, enter QC Run interface as figure 5-10.

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

(1) QC Graph
dialog box, enter the X-R QC interface as figure 5-11 in where operator can
review 12 parameters QC results. The dot on X-R QC Graph indicates mean
value or range of two QC results. The system cannot display low, normal and
47
Quality Control
high control graphs simultaneously in one interface, please click Group to

change.
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.
There are function buttons at the bottom of X-R QC interface. Click Group to
instance, WBC changes to RBC. Click Level to shift the classification line
between the X and R graphs. Click Left or Right to shift the classification line in
X or R graph. Click Print to print the current data.
Figure 5-11

48
Quality Control
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
×R.
 upper limit —— R upper limit＝B×R
 middle line —— R
 lower limit —— R lower limit＝C×R
(3) QC Data
49
Quality Control
5-12.
the data.
X-R QC data interface can only display three controls result, and each one
contains mean and range. The first two lists on this interface are total mean
and average range（see figure 5-12）.
The QC data would be updated after running two new controls.
Figure 5-12
5.2.4 X-B QC
5.2.4.1 X-B QC Edit
X-B QC Edit is different to others, with which the system only edits three
parameters: MCV, MCH, and MCHC.
50
Quality Control
Select X-B QC in figure 5-1 and click OK to enter the X-B QC interface, then
click Edit to enter X-B QC Edit interface as figure 5-13.
On the bottom of this Edit interface, click Delete to delete current assay and
limit; click OK to save them; click Back to exit.
saved in database.
Figure 5-13
5.2.4.2 X-B QC Run
X-B QC is a moving average method, which needs no control material.
Click Run in the X-B QC interface to enter the X-B QC Run interface as figure
5-14. The “X-B QC Run” is selected to make the subsequent QC is X-B or not.
“Swatch number” is used to select the quantity of each group of samples. For
example, if the “X-B QC Run” is ON and “Swatch number” is 20, the
subsequent 20 controls count will be X-B QC counts.
51
Quality Control
Click OK to save the current selections.

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

(1) QC Graph
dialog box, enter the X-B QC interface as figure 5-15 in where operator can
review 3 parameters QC results. After the count of group samples completed,
the results of MCV, MCH, MCHC will depict a dot on the graph. For example,
the “X-B QC Run” is ON and “Swatch number” is 20, then after the subsequent
20 counts, the system will calculate a X-B QC value and a corresponding
control dot which will display on the graph.
On the X-B QC interface, there are three graphs of MCV, MCH and MCHC.
52
Quality Control
The graphs will update at the same time of QC counting.

The function buttons are basically as the same as other QCs with additional
Pgpre and Pgnex.
QC Graph instruction:
limit.
53
Quality Control
Figure 5-15
(2) QC Data
5-16. Click Left or Right to view the data on next page, operator could review
30 items data at most. Click Delete All to delete all the data. The Assay and
Limit are input and changed in QC Edit.
The QC data would be updated and added after running a new control.
54
Quality Control
Figure 5-16
55
Chapter 6 Calibration
To ensure the analyzer’s precision and obtain reliable test results, the
parameters (WBC, RBC, PLT, HGB, and MCV) should be calibrated in the
following situations:
a) Working environment changes greatly.
b) One or multiple parameters’ test results are moving.
c) Any major component that could affect the measurement is replaced.
d) Requirement of the clinic or the laboratory.
e) The reagent has been replaced.
f) The analyzer presents deviation when running quality control.
MCV, HCT are relative parameters to each other, thus one can be obtained
from given value of the other. Only MCV will be calibrated by the analyzer.
Usually the manufacturer will give the reference value for MCV, HCT at the
same time.
CAUTION: Only calibrators recommended by URIT can be used to accomplish
the calibration.
CAUTION: Follow the recommendations provided by manufacturer to store the
calibrators.
CAUTION: Check if the container is broken or cracked before using the
calibrator.
CAUTION: Make sure the calibrators are brought to room temperature and
well mixed slowly before use.
CAUTION: Make sure the calibrators are within the expiry date.
CAUTION: Make sure the analyzer has no problem before calibration.
56
Calibration
CAUTION: Never apply the test data to laboratory or clinic use unless all
parameters are accurately calibrated.
57
Calibration
6.1 Preparation for calibration
Before calibration, inspect the analyzer as following requirements:

（1） Ensure the adequate reagents are in shelf life and uncontaminated.
（2） Run a background test and make sure the results are qualified.
（3） The analyzer occurs no error.
（4） Verify the precision of the analyzer. At Hematology Analyzer, run normal
control for 11 times, query the results from second to eleventh result
precision in Query, make sure the CVs are accordance with table 1-1
precision.
（5） Carryover is determined by running high control of WBC, RBC, HGB,
HCT and PLT. The high control is run in triplicate followed by three diluent
running cycles. The percent carryover is calculated using the following formula
and result is conformed to table 6-1.
Table 6-1 Carryover

Parameter Result
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
HCT ≤0.5%
PLT ≤1.0%
NOTE: If whole blood and capillary blood are both used in daily work,
whole blood mode and pre-diluent mode should be calibrated before
processing samples.
CAUTION: If any malfunction occurs during measurement, the test results are
invalid. Repeat the measurement after troubleshooting.
58
Calibration
6.2 Calibration Manually
At Hematology Analyzer, click Calibration to enter System Calibration interface

as figure 6-1. The default mode is manual mode. Input assay and values, then
click the New Cal button, the system will calculate the new calibrated value
automatically.
Figure 6-1 System Calibration
Click OK to save the new calibration values.

Click Print to print the new calibration values.
Click Back to exit the System Cal.
The counting principle of new calibration value:

 Mean value=(value1＋value2＋value3＋value4)/ 4
 New calibration value=(assay/mean value) ×former calibration value
 If the new calibration value<70%, consider it equals to 70%; if the new
calibration value>130%, consider it equals to 130%
NOTE: The calibration coefficient is allowed in the range of 70%~130%, if
the test values exceed the limit; the maximum value in the limit range
59
Calibration
should be selected as new coefficient for calibration.

NOTE: The analyzer can calibrate a certain parameter of WBC, RBC,
HGB, MCV, MPV, RDW_CV, RDW_SD, PLT and PDW. Also it can
calibrate all the parameters.
CAUTION: If any malfunction occurs during measurement, the test results
are invalid. Repeat the measurement after troubleshooting.
6.3 Calibration Automatically
Click the Manual Mode button on the top right corner of System Cal interface,
switch the mode to interior calibration as figure 6-2.
Figure 6-2
At interior calibration, input assay, place the calibrator tube under the
aspiration probe, press RUN key, the analyzer starts to count, and display the
values in Value1 to Value4 according to the sequence of 4 counts.
The analyzer cannot count or display the test value in following conditions:
1、 Press RUN key after 4 counts, the analyzer will prompt that there is no
space to process calibration count.
2、 If the precision of the results is abnormal, the system will prompt to
60
Calibration
recount. After each counting, the analyzer will calculate the new
calibration value according to the reference value and test result, and
update it.
Click Print to print the new calibration values.
The counting principle of interior calibration is the same as the manual mode.
NOTE: Click OK after counting and the system will save the values. Click Back
without clicking OK, the value will not be saved.
61
Chapter 7 Parameter Limit
To monitor abnormal blood sample measurement, it is essential for the

operator to setup normal ranges of the parameter according to laboratory or
clinical requirement. Information or indication is given if the test values exceed
the range. The limits of 19 parameters are discussed in this chapter, any
results exceeding the range will be marked H (High) or L (Low). H means the
results are higher than the upper limits, while L means the results are lower
than the lower limits.
CAUTION: The shift in parameter limit may cause changes in abnormal
indication of hematology index. Please confirm the necessity for changing.
7.1 Limit Review
At Limit Setting interface, operator may input proper parameter limits or use
the default limits. Default limits are different depending on the patient group.
Figure 7-1 depicts the Man group limits, and figure 7-2 depicts the User1 group
limits.
Figure 7-1
62
Parameter Limit
Figure 7-2
Click Default, the system prompts the operator whether to recover all the
default limits. Select Yes to recover all groups of parameter to default limits;
select No to quit the operation.
Click OK in Limit Setting to save the current default limits which will display
when operator enter Limit Setting interface again.
7.2 Limit Modification
Operate as following procedures to modify the parameter limit:

1. At Hematology Analyzer, click Function, then click Limit to enter limit
setting interface.
2. Click Group, the screen displays the lower and upper limits of current
group of parameters.
3. Select the lower or upper limit of which parameter operator wanted to
modify, delete the former limit using the Backspace key on the
keyboard, input the new lower or upper limit.
4. Click OK, and then select Yes or No to save the modification or not.
63
Parameter Limit
7.3 Print
Click Printer, the system will print all groups of parameter limit in list format.
64
Chapter 8 Maintenance
Routine care and regular maintenance are essential to keep the best status
and precision, to minimize system problems, as well as to prolong the life span.
Procedures and instructions for preventive maintenance are discussed in this
chapter. More information is available at URIT Customer Support Centre.
Preventive maintenance should be performed daily, weekly and yearly.
Pertinent maintenance is also included in this Chapter according to actual
requirement.
WARNING: Analyzer failure will occur unless a normative maintenance
criterion is performed strictly.
WARNING: Perform individual protection before instrument maintenance, such
as wear glove, respirator, lab coat etc.
8.1 Daily Maintenance
URIT-3010 is designed with daily auto-maintenance program. In figure 8-1,

select an auto-clean time to maintain the system. And the following is
recommended:
Run time (hour) Time for auto-clean (hour)
>8 8
4< Run time<8 4
Run time< 4 2
65
Maintenance
Figure 8-1
8.2 Weekly Maintenance

8.2.1 Surface Maintenance
Clean the smudge on the surface, especially the spilt blood on the aspiration
probe and surrounding, to remove the protein buildup or debris and reduce the
possibility of a blockage. Wipe the outside of the probe and surrounding with
gauze soaked by litmusless detergent before cleaning other parts.
CAUTION: Never use corrosive acids, alkali or volatile organic solvent (such
as acetone, aether and chloroforms) to wipe the outside of the analyzer, but
only litmusless detergent.
8.2.2 Monthly Maintenance
Monthly maintenance mainly aims at mechanism maintenance, including

lubricate electricity axis, X, Y leader of sampling organ etc.
NOTE: Perform monthly maintenance under guide of URIT customer
service.
WARNING: Please insure instrument is shut off before maintenance.
66
Maintenance
8.3 System Maintenance
At Hematology Analyzer select Function, then select Maintain to enter the

interface like figure 8-2.
Figure 8-2
URIT-3010 offers eight maintenance functions as follows:

 H.V Cautery
 Flush
 Prime
 Fill Lyse
 Fill Diluent
 Fill Detergent
 Tubing Clean
 Prepare Shipping
8.3.1 H.V Cautery
H.V Cautery may prevent and eliminate blockage. Procedures as follows:

1. Select H.V Cautery in Maintain interface.
67
Maintenance
2. The analyzer starts to perform the function and display the progress
bar at the bottom of the screen.
3. The operation is completed and back to the Maintain interface.
8.3.2 Flush
Flush function may rinse the ruby aperture and prevent and eliminate blockage
associating with H.V Cautery. The procedures as follows:
1. Select Flush in Maintain interface.
8.3.3 Prime
Prime function may rinse the ruby aperture to prevent blockage if the counting
time is too long. The procedures as follows:
1. Select Prime in Maintain interface.
8.3.4 Fill Lyse
NOTE: Keep the lyse still for a certain time to ensure it stable.
NOTE: After replacement of diluent, detergent or lyse, perform background
test to make sure the background values are in acceptable range.
In the following conditions, perform this operation:
68
Maintenance
 There are bubbles in lyse tubing.

 The lyse in tubing is contaminated.
 Replace a new lyse.
The procedures as follows:
1. Select Fill Lyse in Maintain interface.
8.3.5 Fill Diluent
NOTE: Keep the diluent still for a certain time to ensure it stable.
test to make sure the background values in acceptable range.

 There are bubbles in diluent tubing.
 The diluent in tubing is contaminated.
 Replace a new diluent.
1. Select Fill Diluent in Maintain interface.
8.3.6 Fill Detergent
69
Maintenance
NOTE: Keep the detergent still for a certain time to ensure it stable.
test to make sure the background values in acceptable range.

 There are bubbles in detergent tubing.
 The detergent in tubing is contaminated.
 Replace a new detergent.
1. Select Fill Detergent in Maintain interface.
8.3.7 Tubing Clean
CAUTION: Consider the probe detergent is corrosive, operator should wear
lab coats, gloves, and follow required laboratory or clinical procedures.
Probe detergent is a kind of alkalescence detergent. Performance of Tubing

Clean is to rinse the WBC and RBC cups, and related tubing with probe
detergent. If the analyzer is non-turnoff, perform Tubing Clean every three
days. If the analyzer is turnoff the power daily, perform Tubing Clean every
week.
70
Maintenance

1. Place the probe detergent under the aspiration probe, making the
probe be able to aspirate the detergent. Select Tubing Clean in
Maintain interface.
2. Remove the detergent after the probe retracted back. The analyzer
starts to perform the function and display the progress bar at the bottom
of the screen, the progress will take about nine minutes.
3. If want to terminate the progress earlier, press ESC key on the
keyboard after 60 seconds. The screen will prompt a dialog box
concerning whether to exit the tubing clean progress.
4. Click Yes to exit the progress and back to the Maintain interface. Click
No to continue.
8.3.8 Prepare Shipping
Perform this function before shipping or leave unused for a long time. Refer to
the 8.4 section for details. The procedures as follows:
1. Select Prepare Shipping in Maintain interface.
8.4 Maintenance before Shipping or Leave Unused for a Long

Time
If the analyzer is leaved unused for three months or before shipping, maintain
the analyzer as following:
a) Take out the diluent inlet tube connecting with diluent port on the rear
panel from container, discharge the diluent remained in tube.
b) Take out the lyse inlet tube connecting with lyse port on the rear panel
from container, discharge the lyse remained in tube.
71
Maintenance
c) Take out the detergent inlet tube connecting with detergent port on
the rear panel from container, discharge the detergent remained in
tube.
d) Keep the remaining reagents in their containers and store them
according to the instructions. Operator should establish and conform
to effective storage measures to prevent reagent from deteriorated,
misusage or misdrinking.
e) Keep the diluent, lyse and detergent inlet tubes hang in the air.
f) At Hematology Analyzer, click Drain several times until the top left
corner of the screen present No Diluent, No Lyse, No Detergent. Click
Drain once again.
g) Insert diluent, lyse and detergent tubes into distilled water.
h) At Hematology Analyzer, click Function, then click Maintain, and then
click Prepare Shipping.
i) After completed, click Prepare Shipping once again.
j) At Hematology Analyzer, click Exit, “Thank you, now turn off power”
will appear to instruct the operator to turn off the power switch on the
rear panel.
k) Pull out the waste outlet tube from the rear panel, clean it with distilled
water and save it with plastic bag after dry by airing.
l) Cover the connectors of DILUENT, LYSE, DETERGENT and WASTE
on the rear panel with caps which taken out at initial installation
m) Disconnect the power cord of analyzer and save it in plastic bag.
Place the analyzer and components in plastic bags into the shipping carton.
72
Chapter 9 Troubleshooting
This Chapter gives instructions for identifying, troubleshooting, and correction

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

and resolving analyzer problems. Instructions are also given for obtaining
technical assistance immediately from 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
Step 1: Problem Identification means not only identifying what is wrong but
also what is right. The investigation should identify the problem area and
eliminate areas that are right. Once done, the trouble shooting process moves
quickly to next step.
Step 2: Problem Isolation means further classifying the problem. Analyzer
problems are generally divided into three categories:
1. Hardware component related

2. Software computer programs related
3. Measurement related to sample analysis
73
Troubleshooting
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.
Step 3: Corrective Action means taking appropriate action to correct the
problem. If the operator can correct the problem, with or without technical
assistance from manufacture, normal operation can quickly resume.
9.2 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 numbers of the reagents (lytic reagent, diluent and detergent)
5. Data and report of the problem
Familiar problems and disposals are given in this Chapter. The operator can
identify the cause according to the warning information and operate according
to Troubleshooting Guide.
9.3 Troubleshooting
Familiar problems and corrective actions are listed as follows. If the problems
can not be corrected, or technical assistance is needed, please contact with
URIT Customer Support Centre.
9.3.1 Faults related to reagents
74
Troubleshooting
Fault Probable Cause Corrective Ation
Lyse empty Lyse is run out or 1. Check that if the lyse is run out.
lyse inlet tube is 2. Perform Func → Maintain →Fill Lyse.
blocked. 3. If fault still occurs, please contact with URIT.
Diluent empty Diluent is run out. 1. Check that if the diluent is run out.
2. Perform Func → Maintain →Fill Diluent.
3. If fault still occurs, please contact with URIT.
Detergent Detergent is run 1. Check that if the detergent is run out.

empty out 2. Perform Func → Maintain →Fill Detergent.
Waste full Waste container is 1. Check that if the waste is full.

full or waste sensor 2. Check that if the sensor is wet or short circuit.
is in fault. 3. If fault still occurs, please contact with URIT.
9.3.2 Fault related to Test Value
Fault Probable Cause Corrective Action

High Diluent is 1. Check that if the diluent is overdue or
background contaminated or contaminated.
value overdue; diluent 2. Perform Tubing Clean at Maintain interface
tube or cups using probe detergent. Run a background test
contaminated. again to check if the fault disappeared.
75
Troubleshooting
HGB HGB background 1. Click Service, input password 2006 to enter

inaccuracy voltage hopping “System test” interface, check the HGB_BACK
and HGB_ZERO.
2. If the HGB_BACK and HGB_ZERO are out of
range, contact with URIT to modify the values.
WBC clog or ruby aperture 1. Perform H.V cautery in Maintain, and then run a
RBC clog clogged; WBC background test to check the counting time.
counting time 2. If fault occurs, perform Tubing Clean in Maintain.
incorrect; solenoid 3. If fault still occurs, please contact with URIT.
valve problem
WBC bubble or 1、 Diluent or 1. Check the diluent and detergent.

RBC bubble detergent run out 2. Check the reagent tubing connection, prevent
or deficient leakage.
2、 Reagent tubing 3. Perform Tubing Clean in Maintain
loose leads to 4. If fault still occurs, please contact with URIT.
leakage
76
Troubleshooting
9.3.3 Fault related to hardware
Fault Probable Cause Corrective Action
Motor sounds 1. motor connecting 1. Click Service, input password 2006 to enter
abnormally. wire loose “System test” interface, ensure the motor items
2. travel switch are in normal conditioin.
problem 2. If fault still occurs, please contact with URIT.
3. motor problem
4. motor drive circuit
problem
Counting time is 1. Ruby aperture 1. If the fault occurs after eliminate the apertture
too long or no clogged. clog, click Service, input password 2006 to enter
counting time. 2. Valve no “System test” interface, ensure the Valves are in
movement. normal conditioin.
77
Chapter 10 Precautions, Limitations and Hazards
Improper operation will never attain optimal performance; even cause damage
to the operator or others. To avoid the damage and get a successful
measurement, a criterion should be designed to perfect the service conditions.
10.1 Limitations
a) The instrument is designed for in vitro diagnostic use.

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

b) Place the analyzer on a stable, level surface. Locate the system
· Away from direct sunlight,
· Away from path of a cooled or heated air outlet with temperature
extremes
· Away from drying ovens, centrifuges, x-ray equipment, copiers or
ultrasonic cleaner.
c) Place the reagent containers on the same level as the analyzer.
d) Adequate space should be provided around the analyzer. 40cm of space
78
Precautions, Limitations and Hazards
e) from the surrounding objects is needed for proper ventilation, and 2m2
space is needed for the analyzer and the reagent. Please do not placed
the instrument in the location where difficult to operate the disconnect
device. Adequate space should be provided around the analyzer to
perform necessary maintenance procedures.
f) Before operating the analyzer for the initial measurement, verify that each
reagent tuning is connected to the appropriate inlet and reagent container.
Make sure the outlet tubing is not twisted and the waste tubing is
connected to the appropriate outlet and routed to a suitable waste
container or drain.
g) Do not disconnect any electrical connection while the power is ON. Verify
the analyzer is well connected with the ground to prevent electrical
interfere and ensure the safety.
CAUTION: Anyone without authorization of URIT should NOT remove the

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

maintenance. Wear gloves, lab clothing and safety glasses to avoid direct
contact to the samples.
b) Consider all the clinical specimens, controls and calibrators etc, that
contain human blood or serum as being potentially infectious, wear
standard laboratory clothing, gloves and safety glasses and follow
required laboratory or clinical procedures when handling these materials.
Do not smoke, eat or drink at working area. Do not suck or blow the tubing.
c) Consider the blood samples and waste have potential source of biological
and chemical hazard, the operator should handle with extreme care during
the disposal process and follow criterion of the local government when
cleaning, handling, discharging.
d) Follow the manual to store reagent, calibrators and controls. The customer
have obligation to take actions and management to prevent the reagent,
calibrators and controls from deterioration, misapplication or eating by
mistake. The reagent should be away from temperature extremes.
79
Precautions, Limitations and Hazards
CAUTION: Reagent will freeze when it is below 0℃, for which the reagent can
not be used.
CAUTION: Keep the reagents away from direct sunlight to avoid evaporation
and contamination. Seal the cap of the container. Minimize the diameter of the
hole to avoid evaporation and contamination.
80
Appendix 1: Instrument Icon and Symbols
Specification
Caution
Caution, risk of electric shock
Biohazard
Equipotentiality
Protective Grounding
Protect from heat and radioactive sources
Consult Instruction for Use
For In Vitro Diagnostic Use
Serial Number
Manufacturer
81

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URIT-3010

Automated Hematology Analyzer

URIT Medical Electronic Co., Ltd.

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

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

1.1 Overview ............................................................................................................ 1

Chapter 2 Principles of Operation............................................................................11

2.1 Principles of Operation ...................................................................................11

Chapter 3 Installation and Specimen Analysis ...................................................... 14

3.1 Unpacking and Inspection ............................................................................. 14

3.4.2 DILUENT Tubing Installation .................................................................. 16

Chapter 4 System Setting ........................................................................................ 31

4.1 System Maintenance ...................................................................................... 31

Chapter 5 Quality Control ........................................................................................ 36

5.1 Quality Control Options ................................................................................. 36

6.1 Preparation for calibration ............................................................................. 58

6.2 Calibration Manually....................................................................................... 59

Chapter 7 Parameter Limit ....................................................................................... 62

7.1 Limit Review .................................................................................................... 62

8.1 Daily Maintenance........................................................................................... 65

Chapter 9 Troubleshooting ...................................................................................... 73

9.1 Troubleshooting Guidance ............................................................................ 73

Chapter 10 Precautions, Limitations and Hazards .................................................. 78

10.1 Limitations ....................................................................................................... 78

Appendix 1: Instrument Icon and Symbols Specification ......................................... 81

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

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

Limited Responsibility for Quality Warranty:

Technical service and troubleshooting are provided by the Service Department

URIT Medical Electronic Co., Ltd.

Wellkang Ltd t/a Wellkang Tech Consulting

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

This manual uses the following warning conventions:

Do read through this manual before operation, maintenance,

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

The URIT-3010 is a multi-parameter, automated hematology analyzer

1.1.1 Intended Use

The URIT-3010 generates the following 19 hematologic measurements on

Table 1-1 19 Parameters

1.1.2 Front Panel

Figure 1-1 Front Panel

System Information Mode System Time

Figure 1-2 Screen

Figure 1-3 Hematology Analyzer Interface

Func: Directs to second category menu.

Second category (from left to right) as figure 1-4:

Figure 1-4 Functional Menus

Back: Returns to the first category.

1.1.3 Rear Panel

Figure 1-5 Rear Panel

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

1.3.1 Flow System

Solenoid Valve--- These contact two-way or three-way solenoid valves control

1.3.2 Electrical System

1.3.2.1 A/D and Mainboard

Mainboard is the control center of the analyzer; it controls the following

service for the computer’s data processing.

1.3.2.2 WBC Metering Assembly

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

1.3.2.3 RBC/PLT Metering Assembly

RBC/PLT Metering Assembly is composed of signal collection board, electrodes,

1.5 Sample Volume

Whole Blood Mode: Whole Blood 10 μL

1.6 Reagent Volume for Single Sample