DC-30 Auto Hematology Anazlyer Operational Manual-ILONGCARE

Auto Hematology Analyzer
Operation Manual
ＳＨＥＮＺＨＥＮ　ＬＯＮＧＣＡＲＥ　ＢＩＯＴＥＣＨ　ＣＯ．，　ＬＴＤ
Introduction
Introduction
We would like to sincerely thank you for choosing to purchase Longcare product.
Please read this manual carefully in order to ensure correct use of the product. After 　
carefully reading this manualplease keep it safely stored so that you can refer to it　　
when necessary.
Product Name: Auto Hematology Analyzer
Model: ＤＣ－３０
This product primarily comprises the reagent and sample
loading units and mixing systems, photoelectric

Product Composition:
colorimetric assembly, cleaning system, data acquisition
unit, control unit and data processing system
This product is applicable for detecting the parameters of
Scope of Product WBC, RBC, PLT, HGB, etc. in anti-coagulated venous whole
Application: blood or capillary blood, as well as WBC 3-part differential
analysis and WBC counting
Date of Manufacture: See the nameplate of the instrument
Manual Revision Date: Jan 01, 2023
Manual Overview
This chapter explains how to use this operation manual, which is shipped with your
auto hematology analyzer and contains reference information about the analyzer
and procedures for operating, troubleshooting and maintaining the analyzer. Read
this manual carefully before operating your analyzer and operate your analyzer
I
Introduction
strictly as instructed in this manual.
Who Should Read This Manual
This manual contains information written for clinical laboratory professionals or
trained doctors, nurses or laboratory technicians to:
1) Learn about hardware and software of the analyzer.
2) Set system parameters.
3) Perform daily operations.
4) Perform system maintenance and troubleshooting.
How to Find Information
This manual contains 11 chapters and 2 appendices. Refer to the table below to find
the information you need.
If you want to… Please refer to…

Chapter 1
Learn about safety and precautions of the
analyzer Safety and Precautions
Chapter 2
Learn about installation requirements of
the analyzer Installation
Chapter 3
Learn about the intended use, parameters,
structure, reagents, etc. of the analyzer System Description
Chapter 4
Learn about how the analyzer works
Working Principles
Learn about the process of sample

Chapter 5
collection and analysis, and how to use the
analyzer to perform your daily operating Basic Operations
tasks
II
Introduction
If you want to… Please refer to…

Chapter 6
Review sample results
Reviewing Results
Learn about the basic requirements of Chapter 7

quality control and how to use the quality
Quality Control
control programs provided by the analyzer
Learn about the basic requirements of Chapter 8

calibration and how to calibrate the
Calibration
analyzer
Chapter 9
Learn about how to set/adjust system
settings Settings
Chapter 10
Learn about how to maintain/service the
analyzer Service
Chapter 11
Learn about how to solve the problems of
the analyzer Troubleshooting
Appendix A.
Learn about the technical specifications of
the analyzer Specifications
Appendix B.
Learn about the hazardous substances that
may contain in the analyzer parts Hazardous Substances
Symbols
You will find the following symbols in this manual:
Symbols Meaning
Alerts the operator to follow the statement below

the symbol, otherwise it may take the risk of
potential biohazard.
III
Introduction
the symbol while in operation, otherwise it may

cause personal injury.

the symbol while in operation, otherwise it may lead
to analyzer damage or unreliable analysis results.

the symbol, which emphasizes the important
information or special attention to be paid while in
operation.
You may find the following symbols on the analyzer, reagent, QC or calibrator:
Symbols Meaning
Consult accompanying documents.
Biohazard
(The background color of this symbol
is yellow, the symbol itself and the
outline is black.)
Equipotential symbol
Protective earthing
USB port
Network port
Alternating current
Authorized representative in the

European Community
IV
Introduction
Symbols Meaning
The following definition of the WEEE

label applies to EU member states
only: The use of this symbol indicates
that this product should not be
treated as household waste. By
ensuring that this product is disposed
of correctly, you will help prevent
bringing potential negative
consequences to the environment and
human health. For more detailed
information with regard to returning
and recycling this product, please
consult the distributor from whom
you purchased the product.
For in vitro diagnostic use
Batch code
Expiry date
Product serial number
Date of manufacture
Be careful of the sampling probe tip
Manufacturer
Temperature limitation
Consult the operation manual
V
Introduction
Symbols Meaning
CE marking. The device is fully in

conformance with the Directive
98/79/EC on in vitro diagnostic
medical devices
This electronic product contains some
poisonous and harmful substances.
The environmental protection use
period is 20 years, after this period, it
should be put into the recycling
system.
Conventions
All illustrations provided in this manual are used for descriptive purposes or as
examples only, not intended to be used for any other purposes. They may not
necessarily reflect setup of the analyzer or data displayed.
Ｍａｎｕｆａｃｔｕｒｅｒ：　ＳＨＥＮＺＨＥＮ　ＬＯＮＧＣＡＲＥ　ＢＩＯＴＥＣＨ　ＣＯ．，ＬＴＤ．　
Ａｄｄｒｅｓｓ：　３Ｅ１００９，Ｙｕｎｚｈｉ　Ｓｃｉｅｎｃｅ　Ｐａｒｋ，　Ｓｈｕａｎｇｍｉｎｇ　Ｒｏａｄ，　Ｄｏｎｇｚｈｏｕ　
Ｃｏｍｍｕｎｉｔｙ，　Ｇｕａｎｇｍｉｎｇ　Ｓｔｒｅｅｔ，　Ｇｕａｎｇｍｉｎｇ　Ｄｉｓｔｒｉｃｔ，　Ｓｈｅｎｚｈｅｎ，　５１８１０７，　Ｃｈｉｎａ
Ｅｍａｉｌ：　ｉｎｆｏ＠ｌｏｎｇｃａｒｅｍｅｄｉｃａｌ．ｃｏｍ
ＷｈａｔｓＡｐｐ: ＋８６　１５８　１５５４　７６０６
SUNGO Europe B.V.

Address: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
Tel: +31（0）2021 11106
Email: [email protected]
VI
Contents
Introduction .................................................................................................................................. I
Manual Overview ........................................................................................................................ I
Who Should Read This Manual ............................................................................................ II
How to Find Information .........................................................................................................II
Symbols ........................................................................................................................................ III
Conventions ............................................................................................................................... VI
Chapter 1 Safety and Precautions ................................................................................................1
1.1 Safety .......................................................................................................................................1
1.2 Precautions ........................................................................................................................... 2
Chapter 2 Installation ....................................................................................................................... 1
2.1 Introduction .......................................................................................................................... 1
2.2 Installer ................................................................................................................................... 1
2.3 Checking before Installation ...........................................................................................2
2.3.1 Inspection for Damage ......................................................................................... 2
2.3.2 Packing List ............................................................................................................... 2
2.4 Installation Requirements ................................................................................................3
2.4.1 Space Requirements .............................................................................................. 3
2.4.2 Power Requirements ..............................................................................................4
2.4.3 Environmental Requirements ............................................................................. 5
2.4.4 Moving and Installation Method ...................................................................... 6
2.5 Precautions for Use ............................................................................................................6
Chapter 3 System Description ....................................................................................................... 1
3.1 Introduction .......................................................................................................................... 1
3.2 Parameters ............................................................................................................................ 1
3.3 Product Structure and Components ............................................................................3
3.3.1 Status Indicator ........................................................................................................5
3.3.2 Buzzer ..........................................................................................................................6
3.3.3 Power Switch ............................................................................................................ 7
3.3.4 Sampling Probe ....................................................................................................... 7
3.3.5 Aspirate Key .............................................................................................................. 7
3.3.6 Touch Screen ............................................................................................................ 7
3.3.7. Analysis interfaces ................................................................................................. 8
3.3.8. Thermal or External Printer (optional) ............................................................8
3.3.9. External Devices ..................................................................................................... 8
3.4 Reagents, Controls and Calibrators ............................................................................. 9
3.4.1 Reagents .................................................................................................................. 10
3.4.2 Controls and Calibrators ....................................................................................10
Chapter 4 Working Principles ........................................................................................................ 1
4.1 Introduction .......................................................................................................................... 1
4.2 Aspiration .............................................................................................................................. 1
4.3 Dilution ................................................................................................................................... 1
4.3.1 Whole Blood Mode ................................................................................................2
4.3.2 Predilute Mode ........................................................................................................ 3
4.4 HGB Measurement .............................................................................................................4
4.4.1 Colorimetric Method ............................................................................................. 4
4.4.2 HGB .............................................................................................................................. 4
4.5 RBC/WBC/PLT Measurement ..........................................................................................4
4.5.1 Electrical Impedance Method ............................................................................ 4
4.5.2 Derivation of RBC-Related Parameters ........................................................... 6
4.5.3 Derivation of WBC-Related Parameters ..........................................................6
4.5.4 Derivation of PLT-Related Parameters ............................................................ 7
Chapter 5 Basic Operations ............................................................................................................ 1
5.1 Introduction .......................................................................................................................... 1
5.2 Initial Checks ........................................................................................................................ 2
5.3 Startup and Login ...............................................................................................................3
5.4 Daily Quality Control ......................................................................................................... 5
5.5 Sample Collection and Handling .................................................................................. 5
5.5.1 Sample Preparation ................................................................................................6
Contents
5.5.2 Sample Analysis .......................................................................................................8

5.5.3 Processing Analysis Results .............................................................................. 13
5.6 Auto Sleep .......................................................................................................................... 18
5.7 Shutdown ............................................................................................................................ 19
Chapter 6 Reviewing Results ..........................................................................................................1
6.1 Introduction .......................................................................................................................... 1
6.2 Browsing in the “Review” Mode ...............................................................................1
6.2.1 Table Area ..................................................................................................................2
6.2.2 Graph Review ........................................................................................................... 2
6.2.3 Check/Cancel Check (for administrators only) ............................................ 3
6.2.4 Delete (for administrators only) ........................................................................ 3
6.2.5 Edit Information ...................................................................................................... 4
6.2.6 Edit Results （for administrators only） ........................................................5
6.2.7 Search ..........................................................................................................................5
6.2.8 Print ..............................................................................................................................6
6.2.9 Transmission ............................................................................................................. 6
Chapter 7 Quality Control ............................................................................................................... 1
7.1 Introduction .......................................................................................................................... 1
7.2 L-J QC ......................................................................................................................................3
7.2.1 Editing L-J QC Settings ......................................................................................... 3
7.2.2 Running L-J QC ........................................................................................................5
7.2.3 Reviewing L-J QC Results .....................................................................................8
7.3 X-B QC ..................................................................................................................................10
7.3.1 Introduction ............................................................................................................10
7.3.2 Editing X-B QC Settings ..................................................................................... 11
7.3.3 Running X-B QC ....................................................................................................15
7.3.4 Reviewing X-B QC Results .................................................................................16
Chapter 8 Calibration ........................................................................................................................1
8.1 Introduction .......................................................................................................................... 1
8.2 When to Calibrate .............................................................................................................. 3
8.3 How to Calibrate ................................................................................................................. 3
8.3.1 Preparing Your Analyzer ...................................................................................... 3
8.3.2 Manual Calibration .................................................................................................5
8.3.3 Calibration with Calibrator .................................................................................. 7
8.3.4 Calibration with Fresh Blood ............................................................................10
Chapter 9 Settings ............................................................................................................................. 1
9.1 Introduction .......................................................................................................................... 1
9.2 System Setup ........................................................................................................................2
9.2.1 Date & Time Setup .................................................................................................2
9.2.2 Parameter Unit Setup ............................................................................................ 2
9.2.3 Print Setup .................................................................................................................3
9.2.4 Communication ....................................................................................................... 4
9.2.5 Maintenance Setup ................................................................................................ 5
9.2.6 Version Info. ..............................................................................................................7
9.3 User Administration ...........................................................................................................7
9.4 Ref. Range Setup .............................................................................................................. 10
Chapter 10 Service .............................................................................................................................1
10.1 Introduction ........................................................................................................................1
10.2 Maintenance ...................................................................................................................... 2
10.2.1 Replace LH Lyse or Diluent ............................................................................... 3
10.2.2 Rinse Impedance Channel .................................................................................4
10.2.3 Flush Aperture ....................................................................................................... 4
10.2.4 Soak Chamber ....................................................................................................... 5
10.2.5 Pack up & Storage ............................................................................................... 6
10.3 Viewing Logs ......................................................................................................................7
Chapter 11 Troubleshooting .......................................................................................................... 1
11.1 Introduction ........................................................................................................................1
11.2 Fault Information and Handling ................................................................................. 1
Contents
Appendix A Specifications ..................................................................................... 1

A.1 Classification ............................................................................................... 1
A.2 Reagents .......................................................................................................1
A.3 Applicable Tubes ....................................................................................... 1
A.4 Parameters ...................................................................................................2
A.5 Sampling Features .................................................................................... 3
A.5.1 Sample Volumes Required for Each Analysis ......................3
A.5.2 Throughput ..................................................................................... 4
A.6 Performance Indicators ...........................................................................4
A.6.1 Display Range .................................................................................4
A.6.2 Background/Blank Count ........................................................... 4
A.6.3 Linearity Range .............................................................................. 5
A.6.4 Accuracy ........................................................................................... 5
A.6.5 Precision ........................................................................................... 6
A.6.6 Carryover ..........................................................................................6
A.7 Input/Output Device ................................................................................7
A.7.1 External Computer (Optional) .................................................. 7
A.7.2. Keyboard (Optional) ....................................................................7
A.7.3. Mouse (Optional) ......................................................................... 8
A.7.4. External Barcode Scanner (Optional) .................................... 8
A.7.5. Printer (Optional) ......................................................................... 8
A.8 Interfaces ......................................................................................................8
A.9 Power Supply ..............................................................................................8
A.10 EMC Description ..................................................................................... 8
A.11 Sound Pressure ........................................................................................9
A.12 Operating Environment ........................................................................9
A.13 Storage Environment .............................................................................9
A.14 Dimensions and Weight .................................................................... 10
A.15 Safety Classification ............................................................................ 10
Appendix B Hazardous Substances ....................................................................1
Safety and Precautions
Chapter 1 Safety and Precautions
The following are warning symbols used for the analyzers. Ignoring these symbols
may result in death or serious injury. The order in which the symbols are given is in
no way indicative of importance and all symbols are of equal importance.
1.1 Safety
Bodily Injury
1) Keep away from the sharp parts of the analyzer, such as
sampling probe tip, reagent probe tip and stirrer in case
of body injury.
2) Do not touch the moving parts, such as sampling probe,
reagent probe, stirrer and fan when the analyzer is
running.
Electric Shock
1) Front, side and back covers mustn’t be opened when
the power is on, except by authorized service personnel.
2) Do not splash liquid on the analyzer’s worktop. In case
liquid gets into the analyzer, turn off the power and
contact Longcareor its local distributors immediately.
3) Keep away from the inside of computer and printer in
case of high voltage.
Chapter 1-1
Biohazard
1) All test samples, calibrators, controls, etc., should be
considered contagious and protective gloves should be
worn when coming into contact with these objects.
2) All waste liquid should be considered contagious and
protective gloves should be worn when coming into
contact with it.
3) Parts that have contacts with samples, such as sampling
probe, reagent probe, stirrer, cuvette, waste liquid tubing
and waste liquid container should be regarded as
contagious and protective gloves should be worn when
coming into contact with these objects.
4) When the instrument reaches its service life, it should be
disposed according to the requirements of the local
environmental protection department, cannot be
disposed and discarded as common wastes.
1.2 Precautions
Intended Use
1) The analyzer is designed for in vitro quantitative determination of
clinical chemistries in serum, plasma, urine and cerebrospinal fluid 　
(CSF) samples. Please consult Longcarefirst if you want to use the
Chapter 1-2
system for other purposes.
2) To draw a clinical conclusion, please also refer to the patient’s
clinical symptoms and other test results.
Operator
The analyzer can only be operated by personnel who have trained 　
and authorized by Longcareor its local distributors.
Actions taken in case of failure
If the instrument has dangerous failure, such as fire, odor, smoke, etc.,
anyone can directly disconnect the power of the instrument or the 　
main power and contact Longcareimmediately.
Operating Environment
1) Please install and operate the analyzer in an environment
specified by this manual. Installing and operating the analyzer in
other environment may lead to unreliable results and even
analyzer damage.
2) If the operating environment of the analyzer needs to be
modified, please contact Longcareor the authorized Longcare 　
distributor for you region.
Electromagnetic Interference
1) The analyzer is susceptible to electromagnetic interference during
operation which may affect test results and lead to operational
faults. Please do not use devices that emit electromagnetic
Chapter 1-3
radiation, such as electric drills, mobile phones or interphone
while the analyzer is running
2) The analyzer will emit electromagnetic radiation during operation.
Do not install or use electromagnetically-sensitive devices near
the analyzer.
Improper Grounding
1) The power supply must be properly grounded, or there is a risk of
electric shock.
2) Ground impedance must be less than 0.1Ω. Poor grounding can
cause instability in test results and electrical leakage from the
enclosure, producing an electric shock hazard.
Liquid Leakage
1) Check the pipe joints for possible leakage before conducting
tests. Liquid leakage can cause inaccurate aspiration and
discharge volume.
2) Do not place reagents and samples on the analyzer bench to
avoid liquid spillage or leakage.
Probe Obstruction
Carefully check reagents and samples and make sure they do not
contain insoluble floating substance such as cellulose and protein
fibrin in case the probes may be blocked.
Chapter 1-4
Water Quality
Water quality should meet Class 2 national standards for laboratory
water, otherwise damage to valve and pump as well as difficulty in
cleaning can be resulted.
Device Connection
1) For a device not permanently connected, please do not place it at
a location that is hard to disconnect.
2) For all the external switches or breakers and external over-current
protection device, it is recommended to place them near the
analyzer.
3) Devices connected with the network port of the analyzer should
conform to the requirements of National Standards GB4793 of
China as well as IEC60950.
Analysis Parameters
Perform calibration for different batches of reagents. Incorrect 　
analysis parameters can lead to wrong test results. Please consult 　
Longcareor your reagent supplier for more information.
Treating Waste Analyzer
Materials of the analyzer are subject to contamination regulations.
Dispose of the waste analyzer in accordance with your local or
national guidelines for waste disposal.
Chapter 1-5
Installation
Chapter 2 Installation
2.1 Introduction
The analyzer is tested and packed with care before it is shipped from the factory.
Inspect the carton carefully when you receive your analyzer. If any sign of damage is 　
found, contact Longcarecustomer service department or your local distributor 　
immediately.
 Installation by personnel not authorized or trained by Longcaremay cause
personal injury or damage your analyzer. Do not install your analyzer without
the presence of Longcare-authorized personnel.
 The installation, authorization, upgrade and modification of the analyzer
software must be performed by Longcare-authorized personnel.
2.2 Installer
The analyzer should only be installed by Longcare personnel or
Longcare-authorized distributor. Users should provide appropriate environment
and space for the installation. When the analyzer needs to be relocated, please
　
contact Longcareor Longcare-authorized distributor. When you received your

　　
analyzer, please immediately notify Longcare or its authorized local distributor.
Chapter 2-1
Installation
2.3 Checking before Installation
2.3.1 Inspection for Damage
All the analyzers have been inspected strictly by Longcarebefore packing and 　
shipping. When you received your analyzer, before opening the packaging, perform 　
a thorough inspection and note whether there is any of the following damage:
1) Up-side-down or distortion of the package.
2) Obvious water marks on the package.
3) Obvious signs of being struck on the package.
4) Package shows signs of having been opened previously.
If you notice any of the above instances of damage, please immediately notify 　
Longcareor Longcare-authorized local distributor.
If the outer package is intact, unpack it in the presence of Longcarestaff and/or 　
authorized distributor personnel, and conduct the following inspection:
1) Check all the parts against the packing list contained inside the package.
2) Check the surface of all the parts for any crack, strike or distortion.
If you notice any shipment damage or missing part, please immediately notify 　
Longcareor Longcare-authorized local distributor.
2.3.2 Packing List
Check all the parts according to the packing list contained inside the package. If
Chapter 2-2
Installation
you notice any missing part, please immediately notify Longcareor its authorized 　
local distributor.
 Check the accessories in the supplied service pack, which is also included in the
packing list.
2.4 Installation Requirements
2.4.1 Space Requirements
Check the site for proper space allocation. In addition to the space required for the
analyzer itself, arrange for:
1) proper height to place the analyzer;
2) at least 50cm between the left and right side door of the analyzer and the walls,
which is the preferred access to perform service procedures;
3) at least 20cm behind the analyzer for cabling and ventilation.
4) enough place under the analyzer for placing the Diluent container and waste
container.
 There should be enough room on and below the worktop to accommodate the
reagents and waste containers.
 The diluent container shall be put within 1.0m under the analyzer, LH Lyse
containers are placed inside the analyzer.
Chapter 2-3
Installation
 The worktop (or the floor) where the analyzer is placed shall be able to
withstand at least 40kg of weight.
2.4.2 Power Requirements
Table 2-1 Power specification
Voltage Input power Frequency
Analyzer 100V～240V AC 120VA 50Hz/60Hz
 Make sure the analyzer is properly grounded.
 Before turning on the analyzer, make sure the input voltage meets the
requirements.
 Please use the analyzer within the conditions specified in this
manual.Exceeding the service conditions will result in abnormal operation of
the analyzer, unreliable measurement results, damage to the analyzer and even
personal injury.
 Using power strip may bring the electrical interference and the analysis results
may be unreliable. Please place the analyzer near the electrical outlet to avoid
using the power strip.
 Please connect the analyzer with the original power cable. Using other power
cable may damage the analyzer or cause unreliable analysis results.
Chapter 2-4
Installation
2.4.3 Environmental Requirements
1) Operating temperature range: 10℃~35℃
2) Relative humidity: 20%~85%
3) Atmospheric pressure: 70.0kPa~106.0kPa
 The environment shall be as free as possible from dust, mechanical vibrations,
loud noises, and electrical interference.
 It is advisable to evaluate the electromagnetic environment prior to operation
of this analyzer.
 Keep the analyzer away from strong sources of electromagnetic interference, as
these may interfere with the proper operation.
 Do not place the analyzer near brush-type motors, flickering fluorescent lights,
and electrical contacts that regularly open and close.
 Do not place the analyzer in direct sunlight or in front of a source of heat or
wind.
 The environment shall be ventilated.
 Place the analyzer on a horizontal flat surface.
 Connect only to a properly earth grounded outlet.
 Only use this analyzer indoors.
Chapter 2-5
Installation
2.4.4 Moving and Installation Method
Moving and installation of the analyzer shall be conducted by Longcare-authorized
personnel. Do not move or install your analyzer without the presence of

　
Longcare-authorized personnel or local distributor.

　
 Installation by personnel not authorized or trained by Longcaremay cause
personal injury or damage your analyzer. Do not install your analyzer without
the presence of Longcare-authorized personnel or local distributor.
 Moving analyzers should follow the appropriate local safety regulations and
use appropriate tools to avoid personal injury.
 Before the analyzer is shipped out, the sampling probe is fixed by a plastic
cable tie to avoid damaging the sampling probe during transportation.
Remove the cable tie before using the analyzer.
2.5 Precautions for Use
1) The analyzer performance may be declined if it has been placed in
environment of high dustiness.
2) The surface of the analyzer shall be cleaned and sterilized regularly with alcohol
(75%).
3) The aspirate key of the analyzer (see Figure 2-1 Front view of the analyzer) shall
Chapter 2-6
Installation
be wiped with alcohol (75%) regularly.
4) Sample collection and preparation must be done following standard
procedures.
5) If any of the pipes or fluidic components is worn out, stop using the analyzer
and contact Longcarecustomer service department immediately for inspection
or replacement.
6) Check and make sure the pipes of reagents, including diluent, LH Lyse and
waste, are not pressed or bent.
7) You must only use the Longcare-specified reagents, otherwise the analyzer
may be damaged or provide unreliable results.
8) Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
Chapter 2-7
System Description
Chapter 3 System Description
3.1 Introduction
This chapter introduces the parameters, major components, interfaces, buttons,
menus, software help system, operation information and reagent system of the
Auto Hematology Analyzer.
3.2 Parameters
The analyzer determines 21 parameters and 3 histograms of blood samples. The
parameters are listed as follows:
Table 3-1 Parameters
Parameter
Name Abbreviation
Group
White Blood Cell count WBC
Lymphocyte number LYM#

WBC group
Lymphocyte percentage LYM%

（
Middle cell number MID#

7 items
Middle cell percentage MID%

）
Granulocyte number GRAN#
Granulocyte percentage GRAN%
Chapter 3-1
System Description
Parameter
Name Abbreviation
Group
Red Blood Cell count RBC
Hemoglobin Concentration HGB
Hematocrit HCT
Mean Corpuscular Volume MCV

RBC group
Mean Corpuscular Hemoglobin MCH

（ 8 items
Mean Corpuscular Hemoglobin

MCHC
Concentration
）
Red Blood Cell Distribution

RDW-CV
Width - Coefficient of Variation
Red Blood Cell Distribution

RDW-SD
Width - Standard Deviation
Platelet count PLT
Mean Platelet Volume MPV

PLT group
Platelet Distribution Width PDW

（ 6 items
Plateletcrit PCT
）
Platelet Large Cell Ratio P_LCR
Platelet Large Cell Count P_LCC
Chapter 3-2
System Description
Table 2-2 Histograms
Name Abbreviation
Red Blood Cell Histogram RBC Histogram
Platelet Histogram PLT Histogram
White Blood Cell Histogram WBC Histogram
3.3 Product Structure and Components
The analyzer mainly consists of a host, accessories and client software. The host
comprises a display screen, aspirate key, fluidic system, optical system, circuit board,
power interface, reagent interface and signal interface.
Chapter 3-3
System Description
Figure 2-1 Front view of the analyzer
1-- Aspirate key 2-- sampling probe 3-- Probe wipe block
4-- Touch screen 5-- Indicator
Figure 2-2 Back view of the analyzer
1-- Waste outlet 2-- Diluent inlet 3-- Waste sensor
4-- Power input socket 5-- Power switch
Chapter 3-4
System Description
Figure 2-3 Left view of the analyzer (left door open)
1-- Network/USB port 2-- Thermal printer
3-- Panel module 4-- LH Lyse reagent position
3.3.1 Status Indicator
The status indicator is on the front of the analyzer. It indicates the ready, running,
failure and sleep status of the analyzer.
The indicator illuminates in 4 colors to indicate the current status of the analyzer.
See the following table:
Table 2-4 Indicator and analyzer status
Analyzer status Indicator Remark
Whole blood mode ready Green light on Sequence is allowed
Predilute mode ready Blue light on Sequence is allowed
Running Yellow light on Sequence is being performed
Chapter 3-5
System Description
Analyzer status Indicator Remark
Sleeping，can be wake up at
Whole blood mode sleep Green light shining
any time
Predilute mode sleep Blue light shining
any time
Sleep with fault Red light shining
any time
An fault has occurred and the

Stop with fault Red light on
analyzer is not running
3.3.2 Buzzer
The buzzer indicates faults of the analyzer or reminders sampling was finished.
Table 2-5 Buzzer and analyzer status
Analyzer status Buzzer Remark
“beep”long whistle Can remove the sample or

sampling was finished
for 1 time reagent from sampling place
Indicate fault, can stop the

“beep”long whistle
fault sound by touching the screen
for 5 time
or remove all the faults.
Chapter 3-6
System Description
3.3.3 Power Switch
The power switch is on the back of the analyzer. It is used to turn the analyzer on
and off.
 Do not turn on/off the switch repeatedly in a short time to avoid damaging the
analyzer.
3.3.4 Sampling Probe
The sampling probe is on the front of the analyzer. It is used to aspirate blood
samples accurately and quantitatively.
3.3.5 Aspirate Key
The aspirate key is located behind the sampling probe. Press it to start analysis,
dispense diluent or exit from standby mode.
3.3.6 Touch Screen
The touch screen is on the front of the analyzer. You can use it to perform interface
operations and complete the display of information.
Chapter 3-7
System Description
3.3.7. Analysis interfaces
1) Power interface
Used to plug in the power cable connected to the power supply.
2) Reagent/Waste outlet
Used to connect with reagents and waste container via fluidic pipes.
3) USB/Network port
The USB port and network port are on the left of the analyzer. They can be used
to connect the keyboard, printer, etc., and to transmit data.
3.3.8. Thermal or External Printer (optional)
The thermal printer is on the left of the analyzer for printing reports . The external
printer is connected to the USB port on the left of the analyzer.
The supported external printer models are: HP Laser Jet P1008,HP Laser Jet
P1007,HP Laser Jet P1006,Brother HL-2030 series,Brother HL-2040 series,Brother
HL-2140 series,BrotherHL-2240 series.
3.3.9. External Devices
1) Keyboard (optional)
The keyboard is connected to the analyzer via the interface on the back of the
analyzer.
2) Mouse (optional)
Chapter 3-8
System Description
The mouse is connected to the analyzer via the interface on the back of the
analyzer. It is used to operate the analyzer.
3.4 Reagents, Controls and Calibrators
As the analyzer, reagents (diluent, LH Lyse, probe cleaner and E-Z cleaner), controls,
and calibrators are components of a system. Performance of the system depends 　
on the combined integrity of all components. Only Longcare-specified reagents
(see Appendix A Specifications), which are formulated specifically for the fluidic
　
system of your analyzer in order to provide optimal system performance, could be

　
used. Do not use the analyzer with reagents from multiple suppliers. Otherwise, the
　
analyzer may not meet the performance specified in this manual and may provide
　
unreliable results. All references related to reagents in this manual refer to the
　
reagents specifically formulated for this analyzer.

　
Each reagent package must be examined before use. Product integrity may be 　
compromised in packages that have been damaged. Inspect the package for signs 　
of leakage or moisture. If there is evidence of leakage or improper handling, do not 　
use the reagent.
 Store and use the reagents as instructed by instructions for use of the reagents.
 When you have changed the diluent or LH Lyse, implement a background test
to see if the results meet the requirement.
Chapter 3-9
System Description
 Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
3.4.1 Reagents
1) Diluent
It is used to dilute blood samples and provide a stable environment for
counting and measure the volume of blood cell.
2) Lyse
It is used to Lyse red blood cell, count and differentiate WBC, and determine
the HGB.
3) Probe cleaner
It is used to clean the fluidic system regularly or remove the fault of analyzer.
4) E-Z cleaner
It is used to soak the fluidic system of analyzer when it is shutdown daily.
3.4.2 Controls and Calibrators
The controls and calibrators are used to verify accurate operation of and calibrate
the analyzer.
The controls are commercially prepared whole-blood products used to verify that
the analyzer is functioning properly. They are available in low, normal, and high
levels. Daily use of all levels verifies the operation of the analyzer and ensures that
Chapter 3-10
System Description
reliable results are obtained. The calibrators are commercially prepared

　
whole-blood products used to calibrate the analyzer. Store and use the controls 　
and calibrators as instructed by their instructions for use.
All references related to controls and calibrators in this manual refer to the controls 　
and calibrators specifically formulated for this analyzer by Longcare. You must buy
those controls and calibrators from Longcareor Longcare-authorized distributors.

　
Chapter 3-11
Working Principles
Chapter 4 Working Principles
4.1 Introduction
The measurement methods used in this analyzer are: the Electrical Impedance
method for determining the RBC, WBC and PLT data; the colorimetric method for
determining the HGB. Other parameter results are obtained via calculation.
4.2 Aspiration
If you are to analyze a sample under the whole blood mode, the analyzer will
aspirate 10μL of the sample.
If you are to analyze a sample under the predilute mode, you should first manually
dilute the sample (20μL of capillary sample needs to be diluted by 700μL of diluent,
dilution ratio: 1:36) and then present the predilute sample to the analyzer, which
will aspirate 300μL of the sample.
4.3 Dilution
The aspirated sample will quickly and precisely be diluted in WBC bath and then
one part of this diluted sample will be diluted in RBC bath for the second time.
After this, they are ready for analysis.
This analyzer can process two types of blood samples - whole blood samples and
Chapter 4-1
Working Principles
predilute samples.
4.3.1 Whole Blood Mode
Chapter 4-2
Working Principles
4.3.2 Predilute Mode
Chapter 4-3
Working Principles
4.4 HGB Measurement
4.4.1 Colorimetric Method
The WBC/HGB dilution is delivered to the HGB bath where it is bubble mixed with a
certain amount of LH Lyse, which converts hemoglobin to a hemoglobin complex
that is measurable at 530nm. An LED is mounted on one side of the bath and emits
a beam of monochromatic light, whose central wavelength is 530nm. The light
passes through the sample and is then measured by an optical sensor that is
mounted on the opposite side. The signal is then amplified and the voltage is
measured and compared to the blank reference reading (readings taken when there
is only diluent in the bath), and the HGB is measured and calculated in the analyzer
automatically.
4.4.2 HGB
The HGB is calculated per the following equation and expressed in g/L.
Blank Photocurrent
HGB = Constant × Ln
Sample Photocurrent
4.5 RBC/WBC/PLT Measurement
4.5.1 Electrical Impedance Method
RBC/WBC/PLT are counted and sized by the electrical impedance method. This
method is based on the measurement of changes in electrical resistance produced
Chapter 4-4
Working Principles
by a particle, which in this case is a blood cell, suspended in a conductive diluent as
it passes through an aperture of known dimensions. A pair of electrodes is
submerged in the liquid on both sides of the aperture to create an electrical
pathway. 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 represents the number of particles
that passed through the aperture. The amplitude of each pulse is proportional to
the volume of each particle.
Figure 4-2 Electrical Impedance Method
Each pulse is amplified and compared to the internal reference voltage channel,
which only accepts the pulses of certain amplitude. If the pulse generated is above
the RBC/WBC/PLT lower threshold, it is counted as a RBC/WBC/PLT. The analyzer
presents the RBC/WBC/PLT histogram, whose x-coordinate represents the cell
volume (fL) and y-coordinate represents the number of the cell.
Chapter 4-5
Working Principles
4.5.2 Derivation of RBC-Related Parameters
1) RBC
RBC (1012/L) is the number of erythrocytes measured directly by counting the
erythrocytes passing through the aperture.
2) MCV
Based on the RBC histogram, this analyzer calculates the mean cell volume
(MCV) and expresses the result in fL.
3) HCT, MCH, and MCHC
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows:
�� × ��
HCT =
10
��
MCH =
��
��
MCHC = × 100
��
Where the RBC is expressed in 1012/L, MCV in fL and HGB in g/L.
4) RDW-CV
Based on the RBC histogram, this analyzer calculates the CV (Coefficient of
Variation) of the erythrocyte distribution width, which is expressed in %.
5) RDW-SD
Based on the standard deviation of erythrocyte size distribution, this analyzer
calculates the RDW-SD, its unit is fL.
4.5.3 Derivation of WBC-Related Parameters
1) WBC
Chapter 4-6
Working Principles
WBC (109/L) is the number of leukocytes measured directly by counting the
leukocytes passing through the aperture.
2) MON, MID, GRAN
Based on the WBC histogram, this analyzer calculates the number (109/L) and
percentage (%) of different kind of white blood cell.
4.5.4 Derivation of PLT-Related Parameters
1) PLT
PLT (109/L) is measured directly by counting the platelets passing through the
aperture.
2) MPV
Based on the PLT histogram, this analyzer calculates the mean platelet volume
(MPV, fL).
3) PDW
Platelet distribution width (PDW) is the geometric standard deviation (GSD) of
the platelet size distribution. Each PDW result is derived from the platelet
histogram data and is reported as 10(GSD).
4) PCT
This analyzer calculates the PCT as follows and expresses it in %.
�� × ��
PCT =
100000
Where the PLT is expressed in 109/L and the MPV in fL.
Chapter 4-7
Basic Operations
Chapter 5 Basic Operations
5.1 Introduction
This chapter provides step-by-step procedures for operating your analyzer on a
daily basis. The operation process of sample analysis in different working modes is
described in detail.
 All samples, controls, calibrators, reagents, wastes and areas contacted them
are potentially biohazardous. Wear proper personal protective equipment (e.g.
gloves, lab coat, etc.) and follow safe laboratory procedures when handling
them and contacted areas in laboratory.
 Do not contact the patients’ sample blood directly.
 Be sure to dispose of reagents, waste, samples, consumables, etc. according to
government regulations.
 The reagents are irritating to eyes, skin and mucosa. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.
 If reagents accidentally spill on your skin or into your eyes, rinse the area with
plenty of clean water and seek medical attention immediately.
Chapter 5-1
Basic Operations
 Keep your clothes, hairs and hands away from the moving parts to avoid injury.
 The sampling probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
 Do not reuse disposable products such as collection tubes, test tubes, capillary
tubes and so on.
 When operating the touch screen, do not use sharp objects or excessive force.
 Use the reagents specified by the Longcareonly. Store and use the reagents as
instructed by instructions for use of the reagents.
 Check if the reagent tubes are properly connected before using the analyzer.
 Be sure to use clean EDTAK2 or EDTAK3 anticoagulant collection tubes, fused
silica glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary
tubes.
 Be sure to use the evacuated collection tubes recommended in the Appendix.
 Be sure to use the Longcare-specified disposable products including evacuated
blood collection tube, anticoagulant collection tubes and capillary tubes etc.
5.2 Initial Checks
Perform the following checks before turning on the analyzer:
1) Checking the waste container
Chapter 5-2
Basic Operations
Check and make sure the waste container is not full.
2) Checking reagents
Check to see if the reagents are expired or frozen. Reagents must stand for 24
hours before use.
3) Checking tubing and power connections
Check and make sure the reagents, waste and pneumatic unit tubes are
properly connected and not bent. Check and make sure the power cable of the
analyzer is properly plugged into the power outlet.
4) Checking the thermal printer or external printer (optional)
Check and make sure enough printer paper is installed. Check and make sure
the power cable of the printer is properly plugged into power outlet, and the
printer is properly connected to the analyzer.
5.3 Startup and Login
1) Start up the analyzer:Change the power switch at the backside to ON position
(“I”) will power on the instrument.
2) The indicator light turns on.
3) System initialize automatically.
4) Enter the current user name and the password respectively into the “User
Name” box and the “Password” box.
Chapter 5-3
Basic Operations
 If the software cannot be started successfully after being launched for several
times, contact Longcarecustomer service department or the authorized
distributors.
 After starting up the analyzer, check if the date/time is correct.
 The default user name are “admin”and the password is “admin”.
 The user name and password may be consisted of 1-12 letters, and the
password cannot be null.
5) Click “Login” to enter the system.
Chapter 5-4
Basic Operations
 If fault occurs during the initialization process (e.g., background check fails), the
analyzer will report the fault. See Chapter 11 Troubleshooting for the solution.
 See Appendix A Specifications for the background range of each parameter.
 The system opens different function for the user according to the user level.
The user level depends on the user name and the password when the user logs
in.
 If user switching is necessary, click the “Logout” icon on the system menu.
Enter the desired user name and the password into the pop-up dialog box and
click the “OK” button to log in.
 Running sample with the background abnormal fault present will lead to
unreliable results.
5.4 Daily Quality Control
Perform daily quality control before running any samples. See Chapter 7 Quality
Control for details.
5.5 Sample Collection and Handling
 All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
Chapter 5-5
Basic Operations
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
 The sampling probe is sharp and potentially biohazardous. Do not contact the
sampling probe during operations.
 Do not reuse disposable products such as collection tubes, test tubes, capillary
tubes and so on.
 Make sure the probe tip does not contact the sample tube to avoid potential
spillage.
5.5.1 Sample Preparation
The analyzer can run 2 types of samples: whole blood samples and predilute
samples.
Chapter 5-6
Basic Operations
 Prepare samples following the recommend procedure of the manufacturer.
 All samples shall be mixed as shown in the following figure.
 Samples placed for a period of time need to be remixed before testing.
1) Whole blood samples
a) Use clean EDTAK2 or EDTAK3 anticoagulant collection tubes to collect
venous blood samples.
b) Mix the sample according to your laboratory’s protocol.
 Be sure to collect at least 0.5mL of blood to ensure the accuracy of the results.
2) Predilute samples
a) Click the diluent dispensing icon, the following dialog box pops up.
b) Present a clean tube to the sampling probe, press the aspirate key to
dispense diluent (700μL). The dispensing progress bar will be displayed on
the interface.
c) To continue with diluent dispensing, repeat the step 1-2.
d) Add 20μL of venous blood or capillary blood to the diluent, close the tube
cap and mix it properly according to your laboratory’s protocol.
e) Click “Cancel” after preparing all the samples, the analyzer will clean the
sampling probe automatically.
Chapter 5-7
Basic Operations
 You can also use pipette to aspirate 700μL of diluent.
 Be sure to keep dust from the prepared diluent.
 After mixing the capillary sample with the diluent, be sure to wait 3 minutes
and then remix before running the sample.
 Be sure to run the predilute samples within 30 minutes after the mixing.
 Be sure to mix any sample that has been prepared for a while before running it.
Do not mix the samples with massive force using swirl mixer.
 Be sure to evaluate predilute stability based on your laboratory’s sample
population and sample collection techniques or methods.
5.5.2 Sample Analysis
Click “Analysis” to enter the sample analysis interface. Click “Sample Mode”
button to select “Whole Blood”, “Predilute” mode.
1) Entering sample information
Chapter 5-8
Basic Operations
If you want to enter sample information after analysis, you may skip this
chapter, and enter sample information at the result review interface (see
Chapter 6 Reviewing Results).
a) Entering the ID
Enter the ID in the “ID” box.
b) Entering the medical record number
Enter the medical record number in the “Patient No.” box.
c) Entering the patient name
Enter the patient name into the “Name” box.
d) Selecting patient gender
Select patient gender from the “Gender ” pull-down list. There are two
Chapter 5-9
Basic Operations
options: “Male” and “Female”.
e) Selecting blood type
Select patient gender from the “Blood type” pull-down list.
f) Entering the patient’s age
The analyzer provides four ways for you to enter the patient’ s age - in
years, in months, in days and in hours. The first way is designed for the
adult or pediatric patients no younger than one year; the second for the
infant patients one month to two years; the third for the neonatal no older
than one month, and the fourth for the neonatal no older than 48 hours.
You may choose one of the four ways to enter the patient age.
g) Entering the patient type
Select patient type from the “Patient Type” pull-down list. There are four
options: “Outpatient Clinic”,”Hospitalization”,”Medical
Examination”.
h) Entering the department name
Enter the name of the department into the “Department” box or select it
from the “Department” pull-down list (when there are previously saved
records in the list). The saved contents will be added in the pull-down list
automatically.
i) Entering the bed number
Enter the number of the patient’s bed into the “Bed No.” box.
j) Entering the sampling time
Chapter 5-10
Basic Operations
Enter the time when the sample is collected into the “Sampling Time”
box.
k) Entering the delivery time
Enter the delivery time of analysis into the “Send Time” box.
l) Entering the clinician
To enter the name of the person who sent the sample for analysis, enter
the name into the “Sender” box or select the desired name from the
“Sender” pull-down list (if there are previously saved names in the list).
The saved contents will be added in the pull-down list automatically.
m) Entering comments
Enter comments in the “Remark” box.
n) OK
When you have finished entering the work list information, click the “OK”
button to save the changes and return to the sample analysis interface.
o) Cancel
If you do not want to save the entered work list information, click the
“Cancel” button to return to the sample analysis interface without saving
the changes.
2) Selecting mode
Make sure the analyzer indicator is solid green. Select whole blood, or predilute
mode based on your needs on the mode selection interface. The selected
mode will be displayed at the bottom of the interface.
Chapter 5-11
Basic Operations
3) Aspirating sample
Present the sample to the sampling probe. Press the aspirate key to start the
analysis.
4) Removing the sample
The sampling probe will automatically aspirate sample. When you hear
the”beep” sound, you may remove the sample.
5) Auto analysis and result reporting
The analyzer will automatically run the sample. When the analysis is finished,
the results will be displayed on the interface.
Chapter 5-12
Basic Operations
 During the analysis, if faults like clog or bubble occur, the analyzer will
automatically display results of related parameters as invalid, and alarm
information will show on the fault information area. See Chapter 11
Troubleshooting for the way to remove faults.
 If the ambient temperature is out of the allowed range, thus causing the
analyzer temperature (the temperature tested by the sensor inside the analyzer)
goes out its specified range, the analyzer will alarm you for abnormal ambient
temperature and the analysis results may be unreliable. See Chapter 11
Troubleshooting for solutions.
5.5.3 Processing Analysis Results
1) Saving analysis results automatically
The analyzer automatically saves sample results. When the maximum number
of results that can be saved has been reached, the newest result will overwrite
the oldest.
2) Printing and Transmission to LIS
If “ Auto print ” function is enabled, the analyzer will print reports
automatically; and if “Auto transmission” function is enabled, the analysis
results, sample and patient information will be transmitted to LIS automatically.
3) Parameter flags
See the following section for details about parameter flags.
Chapter 5-13
Basic Operations
If the parameter is followed by a “H” or “L”, it means the analysis result has
exceeded the upper or lower limit of the reference range (See section 9.2.3 Ref.
range).
If the parameter is followed by an “R”, it means the analysis result is
questionable.
If you see “*****”in the result, it means the result is invalid or out of the
display range (See Table 5-1 Display range for details).
Table 5-1 Display range
Parameter Display Range
WBC 0.0 ～ 999.9×109/L
GRAN#、MID#、LYM# 0.0～ 999.9×109/L
GRAN%、MID%、LYM% 0.0 ～ 99.9%
RBC 0.00 ～ 18.00 ×1012/L
HGB 0 ～ 300 g/L
HCT 0.0 ～ 80.0 %
MCV 0.0 ～ 250.0 fL
MCH 0.0 ～ 999.9 pg
MCHC 0 ～ 9999 g/L
RDW-SD 0.0 ～ 999.9 fL
Chapter 5-14
Basic Operations
RDW-CV 0.0 ～ 99.9 %
PLT 0 ～ 9999 ×109/L
PDW 0.0 ～ 99.9
MPV 0.0 ～ 99.9 fL
PCT 0.0 ～ 0.9 %
P_LCR 0.0 ～ 99.9 %
P_LCC 0 ～ 9999 ×109/L
4) Histogram Flags
If the histogram of sample analysis results is abnormal, there will be histogram flags.
Flags can be divided into two categories: WBC Histogram abnormal and PLT
histogram abnormal.
 WBC Histogram abnormal
When the WBC histogram is abnormal, some words such as “R1, R2, R3, R4, Rm”
appear on the right side of the histogram. The meaning is as follows:
R1: It indicates that there are abnormalities in the left area of lymphocyte peak, and
there may be platelet clots, giant platelets, nucleated red blood cell, undissolved
red blood cell, protein and lipid particles, or electrical noise.
R2: It indicates that there are abnormalities between lymphocyte peak and
intermediate cell area, and that there may be atypical lymphocyte, plasma cell,
atypical lymphocyte, primordial cell or eosinophil increase and basophil increase.
Chapter 5-15
Basic Operations
R3: It indicates that there are abnormalities in the area between the intermediate
cell region and the neutrophil peak, and there may be immature neutrophil,
abnormal cell subsets or eosinophil increase.
R4: It indicates that there are abnormalities in the right side of the neutrophil peak,
and the absolute number of neutrophil increase.
Rm: Represents more than two “R” Flags
 PLT Histogram abnormal
When the PLT histogram is abnormal, the word "Pm" will appear on the right side of
the histogram. Its meaning is as follows:
Pm: It indicates that the boundary between platelet and erythrocyte is blurred, and
there may be large platelet, platelet clot, erythrocyte, cell debris and fibrin.
5) Flags of abnormal blood cell differential or morphology
The following table lists all flags and their indications.
Table 5-2 Flags of abnormal blood cell differential or morphology
Flag
Flag Meaning Judgment criterion
Type
WBC decrease Low WBC analysis results WBC < 2.5×109/L
WBC WBC increase High WBC analysis results WBC > 18.0×109/L
Flag
Low granulocyte analysis
GRAN decrease GRAN# < 1.0×109/L
results
Chapter 5-16
Basic Operations
Flag
Type
High granulocyte analysis

GRAN increase GRAN# > 11.0×109/L
results
Low lymphocyte analysis

LYM decrease LYM# < 0.6×109/L
results
High lymphocyte analysis

LYM increase LYM# > 4.1×109/L
results
WBC < 4.0×109/L
All decrease WBC, RBC and PLT low RBC < 3.5×1012/L
PLT < 100×109/L
Possible presence of
microcyte, macrocyte,
The distribution of RBC
RBC abnormity anisocytosis, RBC
histogram is abnormal
agglutination and
RBC
dimorphic histogram
Flag
HGB abnormal or RBC
agglutination, or MCHC > 380 g/L

HGB abnormity
interference may exist or HGB interference
(e.g., WBC high)
Chapter 5-17
Basic Operations
Flag
Type
Microcytic RBC MCV low MCV < 70fL
Macrocytic RBC MCV high MCV > 110fL
Anemia Anemia HGB < 90g/L
RBC increase RBC high RBC > 6.5×1012/L
PLT decrease PLT low PLT < 60×109/L

PLT
Flag
PLT increase PLT high PLT > 600×109/L
5.6 Auto Sleep
When the time for which the analyzer is free from fluidic operations reaches that
you have set (default setting is 10 minutes), The analyzer will enter sleep status, the
screen will switch off automatically, and the probe will be drew back automatically.
 The analyzer will only enter sleep status in the Analysis interface.
 During sleep status, the analyzer can still perform any other operations (e.g.,
printing and transmission) other than human operations.
 Refer to Section 9.2.4 Maintenance Setup for how to edit waiting time before
entering standby mode.
Chapter 5-18
Basic Operations
 Under sleep status, if there are unfinished printing or communication tasks, the
analyzer will go on processing them.
1) Aspirate key
Press the aspirate key to exit the sleep status.
2) Touch screen
Touch the screen to exit the sleep status.
 When exiting from the sleep status, the analyzer will perform different
maintenance operations based on the time consumed entering sleep status.
 If fault occurs when the analyzer is exiting from the sleep status, see Chapter 3
System Description for details.
 After exiting the sleep status, the analyzer will resume its original status. And
the analyzer indicator will also displayed in the corresponding state.see
Chapter 3 for details.
5.7 Shutdown
Perform the shutdown procedure to shut down the analyzer daily.
1) Click the shutdown button on the menu and the following shutdown dialog
box will display.
Chapter 5-19
Basic Operations
2) Click “OK”.
3) When dialog box prompting probe cleaner maintenance displays, place E-Z
cleaner to the sampling probe and press aspirate key. The probe will aspirate probe
cleaner automatically.
4) After shutting down finishes, the message “Please turn off the power of the
analyzer!” will be displayed. Press the Power switch on back of the analyzer to
power off.
 Do not start up the analyzer immediately after it is shut down. Wait for at least
10 seconds.
 To ensure stable analyzer performance and accurate analysis results, be sure to
Chapter 5-20
Basic Operations
perform the shutdown procedure to shut down the analyzer after it has been
running continuously for 24 hours.
 Do not disconnect power during the shutdown process.
 If fault that will affect shutdown occurs during the showdown process, the
analyzer will resume to its original status and report the fault. See Chapter 11
Troubleshooting for solutions.
Chapter 5-21
Reviewing Results
Chapter 6 Reviewing Results
6.1 Introduction
The analyzer automatically saves analysis results. You can review all the analysis
results and histograms either in table or graph mode.
6.2 Browsing in the “Review” Mode
Operators can review, validate, search, edit and export saved results on the
“Review” interface. Click “Review” to enter the following interface.
Chapter 6-1
Reviewing Results
6.2.1 Table Area
The table area lists all analyzed samples, including basic sample information like
sample ID, sample status and so on.
 The table area displays the latest sample results at the top.
6.2.2 Graph Review
Enter “Analysis” to view the analysis results of samples.
Chapter 6-2
Reviewing Results
6.2.3 Check/Cancel Check (for administrators only)
1) Check sample data
Select one or more sample records on the table data interface, click “Check”,
the sample status of the record will be marked with “Checked”.
2) Cancel Check
Select one or more checked sample records at the table data interface, click
“Cancel Check”, the “Checked” will disappear.
6.2.4 Delete (for administrators only)
1) Select the sample record to be deleted in the table area.
2) Click “Delete”, the following dialog box will display.
Chapter 6-3
Reviewing Results
3) Click “Yes” to delete the record, and the dialog box will be closed.
6.2.5 Edit Information
Click the desired sample result and it will be highlighted. Click the “ Edit Info ”
button and the following dialog box will display.
You may edit the sample and patient information, and click “OK ” to save the
change. The information on the table review interface will be refreshed.
Chapter 6-4
Reviewing Results
6.2.6 Edit Results （for administrators only）
Choose the sample which need to be edited and get into the“Graph Review ”
page .Click the “Edit Result”button and the following dialog box will display.“
Modify the results and click “OK” to save the changes. The information on the
graph review interface will be refreshed.
6.2.7 Search
1) Click “Query”, the following dialog box will display
Chapter 6-5
Reviewing Results
2) Enter search conditions into the edit boxes or select them from the pull-down
lists.
3) Click “OK” to start search, the results will be displayed in the table area.
6.2.8 Print
Select sample records which need to be printed, and then click “Print” to print
them. In the table data interface, a “Printed” sign will be applied to each printed
sample in the sample status sector.
 In the sample status sector, “Checked” sign is prior to “Printed” sign.
6.2.9 Transmission
Transmit selected data
1) Select samples to be transmitted at the table data interface.
2) Click “Export”, the following dialog box will display.
3) Select the “Chosen record” or “All records”.
4) Click “OK” to start transmitting specified results to the data management
software.
Chapter 6-6
Reviewing Results
Chapter 6-7
Quality Control
Chapter 7 Quality Control
7.1 Introduction
Quality Control (QC) consists of strategies and procedures that measure the 　
precision and stability of the analyzer. The results imply the reliability of the sample 　
results.
QC involves measuring materials with known, stable characteristics at frequent 　
intervals. Analysis of the results with statistical methods allows the inference that 　
sample results are reliable. Longcarerecommends you run the QC program daily 　
with normal level controls.
A new lot of controls should be analyzed in parallel with the current lot prior to 　
their expiration dates. This may be accomplished by running the new lot of controls 　
twice a day for five days using any empty QC files. The QC files calculate the mean,
standard deviation and coefficient of variation for each selected parameter. The 　
instrument-calculated means of these ten runs should be within the expected 　
ranges published by the manufacturer.
This analyzer provides 2 QC programs: L-J QC and X-B QC.
them are potentially biohazardous. Wear proper personal protective
Chapter 7-1
Quality Control
 The sample may spill from the uncapped collection tubes and cause biohazard.
Exercise caution to the uncapped collection tubes.
 If reagents accidentally spill on your skin or in your eyes, rinse the area with
 Running QC sample with fault present will lead to unreliable results. If faults are
reported during QC analysis, remove the faults first and then continue with the
analysis.
tubes and so on.
 Sample agglutination may result in inaccurate analysis results. Check the
control samples to see if there is any agglutination, if yes, process the samples
according to your laboratory’s protocols.
Chapter 7-2
Quality Control
 Use the controls and reagents specified by Longcareonly. Store and use the
controls and reagents as instructed by their instructions for use.
 Refer to the instructions for use of the control for its use and storage.
 Be sure to mix any control sample that has been prepared for a while before
running it.
7.2 L-J QC
7.2.1 Editing L-J QC Settings
Before running a new lot of controls, you must set up a QC file for each lot of
controls.
1) Click the menu option “QC” -> “L-J QC” -> “Setup”.Enter the L-J QC setup
interface.Click “New”, or select a QC file without QC results, and then click
“Edit”.
4) Enter the lot No. of the controls in the edit box manually.
Chapter 7-3
Quality Control
 The lot No. shall not be empty and up to 1~32 digits can be entered. You can
enter characters, numbers, letters and special characters.
5) Select the control level.
6) Enter the expiration date of the lot.
7) Select the control type.
8) Select the QC mode.
9) Set QC sample ID: if you are used to analyze control together with blood
samples, you can set a unique ID for the control. The analyzer will recognize the
sample as control when it reads the unique ID. After the analysis completes, the
results will be saved into the QC file of the QC sample ID.
10) Enter the target and limits in the edit boxes according to the package insert of
the lot of controls.
Chapter 7-4
Quality Control
11) Click other icons to switch interface and save the QC information.
 Setting limits
You can adjust the format of limits according to the following procedure.
1) Click “Limit Setup”.
2) Click “Absolute value” to display the limits in the form of absolute value, or
click “Percentage” to display the limits in the form of percentage.
3) Click “OK” button to save the settings.
7.2.2 Running L-J QC
You can select one of the two ways below to run controls:
1) Run controls under the “QC” interface.
2) Put controls together with normal samples, and run the controls under the
sample analysis interface.
 From Way A
After editing the QC information, you can start QC analysis by whole blood or
predilute according to the selected QC mode.
1) Click the menu option “QC” -> “L-J QC” -> “Count” to enter the QC count
Chapter 7-5
Quality Control
interface.
 Be sure that the level of the control to be run is the same with the current QC
file, and the control is not expired.
 The expiration date of expired controls is displayed in red.
2) Prepare the control as instructed by the instructions for use of the controls.
3) Run QC analysis.
4) When analysis finishes, the QC results will be displayed in the current interface
and be saved in the QC file automatically.
5) Do the above procedures to continue running QC analysis if necessary.
 The number of QC results can be saved in each QC file is no limited.
Chapter 7-6
Quality Control
 From Way B
After setting special “QC Sample ID” for a control under the QC setup interface,
you can put the control together with normal samples, and run it under the “Count”
interface.
When editing worklist or entering next sample information in the “Next Sample”
dialog box before daily analysis, enter the special“QC Sample ID”as“Sample ID”.
Based on the QC mode selected, you can choose to run QC analysis from whole
blood or predilute.
1) Prepare the control as instructed by the instructions for use of the controls.
2) Refer to section 5.5.1 Sample Preparation for sample preparation under whole
blood and predilute modes.
3) When it is ready to run a sample (i.e. the status icon and the analyzer indicator
is green), present the sample to the sampling probe, and then press the
aspirate key to start QC analysis.
4) When you hear the beep, remove the control.
5) When analysis finishes, the QC results will be displayed in the current interface
and be saved in the QC file automatically.
6) Do the above procedures to continue running QC analysis if necessary.
 The number of QC results can be saved in each QC file is no limited.
Chapter 7-7
Quality Control
7.2.3 Reviewing L-J QC Results
After QC analysis, you can review the QC results in the following ways.
1) QC Graph
2) QC Table
 L-J QC graph review
1) Click “QC Graph” button on the”Count” interface to enter the L-J QC graph
interface.
2) You can click the arrow buttons on the right of the graph to browse graphs of
the parameters. You can click the arrow buttons under the graph to browse all
the QC results.
 L-J QC table review
1) Click “QC Table” button on the “Count” interface to enter the L-J QC table
Chapter 7-8
Quality Control
interface.
2) You can click the arrow buttons on the right of the table to browse all QC
records. You can click the arrow buttons under the table to browse all the
parameter results.
3) You can click the “Print” icon in the status bar to print the QC table.
 Delete (for administrators only)
1) Click “Delete”, the following dialog box will display.
2) Click “Yes” to delete the selected records.
Chapter 7-9
Quality Control
 The operation will be recorded in the system log.
 Export
To export QC information and results of the current QC file, do as follows.
1) Insert an USB and then click “Export”.
2) The system will detect the USB and export data automatically.
3) The prompt “Export succeeded.” will display.
7.3 X-B QC
7.3.1 Introduction
The X-B analysis is a weighted moving average analysis that uses values obtained
from patient samples. It uses the 3 red cell indexes, MCV, MCH and MCHC to
indicate the hematology instrument performance.
It is recommended the X-B analysis be activated when the sample volume of your
laboratory is greater than 100 samples per day. Effective use of X-B requires
randomization of samples and a normal cross section of patients to prevent
skewing of indexes. It observes the trend of QC results in the reference range
formed by the specified target and limits.
The analyzer implements X-B QC on the 3 parameters: MCV, MCH and MCHC, each
Chapter 7-10
Quality Control
group of samples for X-B analysis consists of 20-200 sample results obtained from
normal analysis of both whole blood and predilute modes. The analyzer can save
up to 500 X-B QC results. When the saved QC results have reached the maximum
number, the newest result will overwrite the oldest.
7.3.2 Editing X-B QC Settings
1) Click the menu option “QC” -> “X-B QC” -> “Setup”.
2) Enter the X-B QC setup interface.
3) At the X-B QC setting interface, you may activate/deactivate X-B QC, set
target/limits, and configure the sample validity setup.
 Editing X-B QC settings
1) In the “Samples/Batch” edit box, you may enter the amount of samples
[within the range 20(default) to 200] to be included in calculating for an X-B QC
Chapter 7-11
Quality Control
point.
2) Activate/deactivate X-B QC. If X-B QC is activated, the samples meeting validity
requirements will be included in X-B QC.
 Setting target/limits
Before the X-B QC analysis, you shall set up the target and limit for each
parameter on the X-B QC setup interface.
 The units of target/limit of all parameters are the same as those in the
parameter unit setup interface.
1) In the“Target/Limit”area of the X-B QC setup interface, specify the targets and
limits in the “Target/Limit” table by entering manually.
 Do not leave any of the targets and limits for the QC parameters blank.
 When used for the first time, the default setting will provide the initial values
for the targets and limits of all QC parameters.
2) Click other icons to switch interface and save the settings.
 Setting sample validity
In X-B QC, sample results conforming to any of the following conditions will be
considered as invalid and cannot be used in the QC calculation.
1) Sample results exceeding the linearity range;
Chapter 7-12
Quality Control
2) Background results;
3) Sample results not conforming to the “Sample Validity Setup”;
4) QC data for QC mode other than X-B (e.g. L-J);
5) Calibration data;
6) Results generated while there are faults which could affect the accuracy of the
results (e.g. insufficient aspiration volume or clogging).
“Sample Validity Setup” is to set up the ranges of valid RBC, MCV, MCH and
MCHC results. Only when the results of all these four parameters are within the
specified ranges, the sample results can be used for X-B QC calculation. Do as
follows to set the sample validity.
1) Select “On” to activate X-B QC. On the “Sample Validity Setup” of the X-B
QC setup interface, set the upper and lower limits of the 4 parameters in the
sample validity setup area. The default validity range of each parameter is
shown in the following figure.
2) Click “Yes” to save the setup.
Chapter 7-13
Quality Control
 In the sample validity setup, the upper limit shall be no smaller than the lower
limit. Otherwise, there will be prompted message asking you to revise.
 The valid ranges of the RBC parameters are their linearity ranges; the valid
ranges of other parameters are their display ranges.
 All the entries shall be numbers with only one decimal point. The length of the
number entered cannot be longer than the length of the text box.
 Once the validity range is changed, the previous results will not be used in the
QC calculation as valid results. For example, if 20 valid samples are needed for
the X-B QC calculation, when you change the validity range after 10 groups of
valid sample results have been acquired, these 10 groups of results will be
discarded, and only valid sample results generated afterwards will be used in
the QC calculation.
 The units of lower and upper limits of all parameters are the same as those in
the parameter unit setup interface. See section 9.2.3 Setup - Parameter Unit
Setup.
 Setting limits
You can adjust the format of limits according to the following procedure:
1) Click “Limit Setup”.
2) Click “Absolute value” to display the limits in the form of absolute value, or
click “Percentage” to display the limits in the form of percentage.
Chapter 7-14
Quality Control
3) Click “OK” button to save the settings.
 Restore defaults
If you want to restore the default targets and limits of the parameter, click
“Defaults”. The default values of the target and limits of each parameter are as
follows:
Parameter Target Limits (#)
MCV 90 2.7
MCH 30 0.9
MCHC 340 10
7.3.3 Running X-B QC
After editing X-B QC settings, the system will start X-B QC run automatically.
After every 20-200 results (determined by the setting) are obtained, the system will
perform the X-B calculation once automatically. You can review the result in X-B QC
graph or X-B QC table.
Chapter 7-15
Quality Control
7.3.4 Reviewing X-B QC Results
After QC analysis, you can review the QC results in the following ways.
1) QC Graph
2) QC Table
 X-B QC graph review
1) Click the menu option “QC” -> “X-B QC” -> “QC Graph”, the following
interface will display.
2) Select QC file No., the information of the file and the QC graph will be displayed
on the interface.
3) You can click the arrow buttons under the graph to browse all the QC results.
 X-B QC table review
1) On the X-B QC graph interface, click “QC Table” button to enter the X-B QC
Chapter 7-16
Quality Control
table interface.
2) You can click the arrow buttons on the right of the graph to browse all QC
records.
3) The delete, print and export operations can all be performed same as stated in
the L-J QC table review section.
Chapter 7-17
Calibration
Chapter 8 Calibration
8.1 Introduction
Calibration is a procedure to standardize the analyzer by determining its deviation
under certain specified conditions. In order to get accurate sample analysis results,
you should calibrate the analyzer according to the procedure below when
necessary.
There are three calibration programs available on this analyzer: manual calibration,
auto calibration using calibrators and auto calibration using fresh blood samples.
All the parameters or part of the parameters of WBC, RBC, HGB, MCV, PLT etc. can
be calibrated by the calibration programs.
them are potentially bio-hazardous. Wear proper personal protective
Chapter 8-1
Calibration
tubes and so on.
 Calibration procedures can only be performed by users of the
administrator-level.
 Use the calibrators and reagents specified by Longcareonly. Store and use the
calibrators and reagents as instructed by their instructions for use.
 The analyzer identifies a sample as a calibration sample only if the analysis is
started from the “Calibration” interface.
 Calculation of reproducibility is included in the calibration procedure.
Chapter 8-2
Calibration
8.2 When to Calibrate
The analyzer is calibrated at the factory just before shipment. It is electronically
stable and does not require frequent recalibration if you operate and maintain it as
instructed by this manual. You only need to recalibrate this analyzer if.
1) you are going to use this analyzer for the first time (usually done by a
Longcare-authorized representative when installing the analyzer)
.2) an analytical component has been changed.
3) you are going to re-use the analyzer after a long-term storage.
4) the quality control results indicate there may be a problem.
5) use environment changes significantly.
 All of the measured parameters must be calibrated before readings of the
analyzer can be used as valid analysis results.
8.3 How to Calibrate
8.3.1 Preparing Your Analyzer
Do the following pre-calibration procedures before calibration. If problems are 　
detected during these checks, do not attempt to calibrate the analyzer. If necessary,
contact Longcarecustomer service department or your local distributor for 　
assistance.
Chapter 8-3
Calibration
1) Check and make sure enough reagents have been prepared for the calibration.
You need to start over the calibration if the reagents run out during the process.
2) Check the background (for calibration right after startup) or blank count results.
If the analyzer alarms for abnormal background results, see Chapter 11
Troubleshooting for solutions. (See Appendix A Specifications for the
background range.)
3) Run a vial of normal control consecutively for 10 times under Whole Blood
mode. Enter the review interface to check the reproducibility of the results and
make sure they meet the following requirements.
Param Whole Blood Predilute

Range
eter Precision (CV) Precision (CV)
WBC 3.5×109/L～15.0×109/L ≤ 2.0% ≤4.0%
RBC 3.00×1012/L ~ 6.00×1012/L ≤ 1.5% ≤3.0%
HGB 100 g/L ~ 180 g/L ≤ 1.5% ≤3.0%
MCV 70 fL～120 fL ≤ 1.0% ≤2.0%
100×109/L ~ 149×109/L ≤ 6.0% ≤10.0%

PLT
150×109/L ~ 500×109/L ≤4.0% ≤8.0%
4) It is recommended that you create a log table for your analyzer. This log table
should contain all necessary information that is pertinent to your analyzer.
Suggested items that you may want to include in the log table are: calibration
date, supplier of calibrator, lot number, expected results and limits, and result of
Chapter 8-4
Calibration
background check.
8.3.2 Manual Calibration
Click the menu option“Calibration”->“Manual”to enter the following interface.
 If you log in at the normal user access level, you can only view the calibration
factors. To perform calibration, please log out and then log in at the
administrator access level.
 The whole blood mode and predilute mode’s calibration factors is
independent. Choose the correct testing mode before calibration.
Do as follows to calibrate the analyzer.
1) At the “ Manual ” calibration interface, check the calibration factors and
calculate the new factors according to the following equation:
Chapter 8-5
Calibration
Old factor × Reference value

New factor =
caculated mean value
For example: Suppose the WBC reference value of a calibrator is 8.4, and the
current calibration factor of the whole blood mode is 98.90%.
Run the calibrator under the whole blood mode for 11 consecutive times and
take the WBC results of the 2nd to 11th runs to calculate: 8.1, 8.0, 8.1, 8.1, 8.3,
8.3, 8.2, 8.0, 8.1, 8.3. The obtained CV is 1.5% and the mean value is 8.16, which
meet the requirements.
The new calibration factor is obtained.
98.90%×8.4
New factor= = 101.81%
8.16
The calculated calibration factors shall be between 70.00% ~ 130.00%. In case
of an invalid calibration factor, try to find out the reason (e.g. calibration
material not thoroughly mixed, misoperation, etc.). Then recalibrate the
analyzer and recalculate the calibration factors.
2) Enter the new calibration factors into the factor cell of the parameter that
requires calibration，and click the “Save”button to save these factors.
3) When you switch interface after entering the new calibration factor, a prompt
will display.
a) If the entered calibration factors are valid, a dialog box will pop up asking
you to save the new factor when you are exiting the interface. And the
calibration date of the corresponding parameter changes to the current
system date.
b) If the entered calibration factors are invalid, a dialog box will pop up
Chapter 8-6
Calibration
prompting “Invalid entry” when you are switching to another interface.
The new calibration factor will not be saved, and the calibration date will
not be refreshed.
4) Export
Click “Export”button, then the current calibration factors will be saved into
the USB flash drive.
8.3.3 Calibration with Calibrator
Click the menu option “Calibration” -> “ Calibrator ” to enter the following
interface.
Chapter 8-7
Calibration
 Only Longcare-specified calibrators shall be used. Longcarewill not be
responsible for any erroneous result caused by using other calibrators.
 See the instruction for use of the calibrators for the lot No. ,expiration date and
the target.
 The out-of-range CV% does not influence the display of calibration factors.
Do as follows to calibrate the analyzer with calibrators.
1) Verify the testing mode on the analysis interface，it must be the same mode
which it’s calibration factors will be calibrated.
2) Enter the lot No. of the calibrator into the “Lot No.” box.
3) Enter the reference value into the “Ref. Value” cell which items you want to
calibrate.
4) Prepare the calibrator as instructed by instructions for use of the calibrators.
5) Press the aspirate key to start calibration.
6) After the analysis, the analyzer will have different responses to different analysis
results.
When the current running is done, if there is a parameter whose calibration
data is out of its linearity range but still within the display range, then the
calibration data will be displayed in the list and a message box will also pop up.
Click “OK” to close the message box, and the data will be deleted from the
table without saving automatically.
When the running is done, if there is a parameter whose calibration data is out
of the display range, then the non-numeric parameter values “***” will be
Chapter 8-8
Calibration
displayed in the list and a message box will pop up.
Click “OK” to close the message box, and the data will be deleted from the
table without saving automatically.
The valid results within the linearity range will be displayed directly.
Valid calibration results will be marked with “√” per the default setting, and
will be taken to calculate calibration factors.
After each testing, if some item’s “Ref. Value ”cell don’t have reference
value,a message box will pop up.Click “Yes”will close the box and save the
current testing value temporary, but those item’s calibration factor will not be
calculate and the original calibration factors remain
7) Click “Save”the new calibration factors (≥70.0% and ≤130.0%) will replace old
one, and the related item’s calibration time will change at the same time.
8) If the calibration factors have not been calculated but you switch to another
interface, then a message box will pop up.
Click “Yes” to switch to another interface while discarding the calibration
data and closing the message box. The original calibration factors remain.
9) When calibration count has been performed to a sample for n times (n≥5), the
analyzer will calculate the Mean, CV% and calibration factors of all the
calibration data marked with “√” .
You can select several data to calculate the calibration factors, but only after at
least 5 groups of the data are marked with “√” can you get the calibration
factors. The calibration factors will be refreshed whenever you select “√” or
Chapter 8-9
Calibration
deselect “√”.
When the amount of valid calibration data in the list reaches 10, a message box
“Calibrator current selection calibration data full.” will pop up. Then, if you
press the aspirate key again, the analyzer will not start analysis.
10) There may be two cases when you are switching to another interface:
If the calibration factors of any parameter is out of the range of 70%-130% or
the CV% of any parameter exceeds the reproducibility range, then the
calculated calibration factors of all parameters will not be saved and a message
box will also pop up.
Click “Yes” to close the dialog box and switch to another interface. The
calibration factors and dates of all parameters will not be changed.
11) If the calculated calibration factors of all parameter are within the range of
70%-130% and the CV% of all parameter are also within the reproducibility
range, then a message box “Save new calibration factor?” will pop up. Click
“Yes” to save the new calibration factors while closing the message box and
switching to another interface.
12) Export
Click “Export”button,the the current saved calibration factors will be saved
into the USB flash drive.
8.3.4 Calibration with Fresh Blood
Click the menu option “Calibration” -> “Fresh Blood” to enter the following
Chapter 8-10
Calibration
interface.
 Calibration with fresh blood mode will need 5 times aspirate for 5 fresh blood
sample each , make sure the sample volume is enough to support the
calibration.
 Calibration with fresh blood mode will consumes a lot of reagents, make sure
the reagent volume is enough for support the calibration.
Do as follows to calibrate the analyzer with fresh blood.
1) Prepare 5 normal fresh blood samples as instructed by 5.5.1 Sample
Preparation.
Chapter 8-11
Calibration
2) Run each of the prepared samples on the reference instrument 5 times at least.
Calculate each items’ mean values and use them as the targets. Or perform
measurement and calculation according to the reference method and take the
calculated data as the targets.
3) Verify the testing mode on the analysis interface，it must be the same mode
which it’s calibration factors will be calibrated.
4) Select the ID of current sample from the pull-down box “Sample No.”.
5) Enter the items’ targets into the “Ref. value” cell.
6) Prepare fresh blood (whole blood or predilute)sample.
7) Press the aspirate key to start calibration.
8) When calibration count has been performed to a sample for n times (n≥5), the
analyzer will calculate the Mean, SD for current sample by all the calibration
data marked with “√” automatically.
You can select several data to calculate , but only after at least 5 data are
marked with “√” can you get each items’ Mean and SD for current sample.
The Mean and SD will be refreshed whenever you select “√” or deselect
“√”.
When the amount of valid data in the list reaches 10, a message box “Fresh
blood current selection calibration data full.” will pop up. Then, if you press the
aspirate key again, the analyzer will not start analysis.
9) Select other sample No. from the “Sample No.” pull-down box and analyze
other samples according to Step 7-8 above to obtain the Mean and SD of all 5
Chapter 8-12
Calibration
samples’ items .
10) The new calibration factors will show up when all 5 samples’ Mean & SD are
calculated. Click “Save”the new calibration factors ( ≥ 70.0% and ≤ 130.0%)
will replace old one, and the related item’s calibration time will change at the
same time.
11) If the calibration factors have not been calculated, when switch to another
interface, a dialog box will pop up.
Click “Yes” to close the dialog box and discard the calibration data, then
switch to another interface. The original calibration factors and calibration date
remain the same.
12) If the calculated calibration factors are valid, when switch to another interface,
a dialog box will pop up.
Click “Yes” to close the dialog box and save the current calibration factors
and refresh the calibration time for specific items, then switch to another
interface. Click “No” to close the dialog box and switch to another interface,
the original calibration factors and calibration date remain the same.
13) Export
Click “Export”button,the the current saved calibration factors will be saved to
Chapter 8-13
Settings
Chapter 9 Settings
9.1 Introduction
The analyzer is a flexible laboratory instrument that can be tailed to your working
environment. You can use the “Setup” menu to customize the software options as
introduced in this chapter.
For the security of the settings and data, two access levels are provided to the
operator of the analyzer. The administrator access level provides the operator with
access to more functions or settings, some of which can be configured to be
accessible to operators.
See the following figure for the setup menu.
Chapter 9-1
Settings
9.2 System Setup
9.2.1 Date & Time Setup
Click “Setup” -> “System Setup” -> “Date & Time Setup” in the menu to enter
the following interface. You can set up the date, time and date format of the
analyzer on the interface.
9.2.2 Parameter Unit Setup
Click “Setup” -> “System Setup” -> “Parameter Unit ” in the menu to enter
the following interface. You can set up parameter unit on this interface.
Chapter 9-2
Settings
9.2.3 Print Setup
Click “Setup” -> “System Setup” -> “Print Setup” in the menu to enter the
following interface. You can set up the following contents: Print type,Print
format,Auto print,Print title.
1) Print type
Chapter 9-3
Settings
There are 3 types of print type: “USB Printer(A5)”,“ USB Printer(A4) ” and
“Recorder”. You can select either of them from the pull-down list.
2) Print format
You can select “record with histo. with refer.”,“record without histo. with
refer.”“record with histo.without refer.”“record without histo.without refer.”
You can select either of them from the pull-down list.
3) Auto print
Select “On” or “Off”， you can choose whether automatic print the result
after the sample analysis is finished.
4) Print title
Input the printing title as need.
9.2.4 Communication
Click “Setup” -> “System Setup” -> “Communication” in the menu to enter
the following interface. You can set up the Communication port and
Transmission setting.
Chapter 9-4
Settings
1) Communication port setup
Click the “Local IP”, “Server IP” , "Local Mask” and “Local Gateway” edit
boxes to enter the contents.
2) Transmission setting
Set the transfer options ： whether auto transmission results after sample
analysis; whether transmission results with the histogram.
9.2.5 Maintenance Setup
Click “Setup” -> “System Setup” -> “Maint.Set” in the menu to enter the
following interface. You can set up the following content.
Chapter 9-5
Settings
1) Auto Blank
Select “On” to save the setting if you need to do blank test at each startup.
2) Auto Clean
There are off, 30times, 50times, 75times, 100times, 125times and 150times to
be selected. If you select 50times, the machine will process auto clean when
test number is up to 50 samples. If the analyzer has been switch off when test
samples have not been up to 50 times( such as 45 times), it will count from last
time(46 times) after start up.
3) Diluent Reminder
If you need the reminder of counting function in predilute mode, you can select
“On”. Then a pop-up dialog will appear every time to remind you if you want
to count after setup.
4) Auto Sleep
There are off, 10min，20min, 30min, 40min, 50min，60min to be selected. If you
select 10min, then there is no operation in analysis interface during 10 time,
the machine will go to sleep automatically. You can also setup the sleeping
Chapter 9-6
Settings
time according as need.
9.2.6 Version Info.
Click“Setup”->“System Setup”->“Version”in the menu to enter the following
interface.
You may view the current version information of the analyzer.
9.3 User Administration
Click “Setup” --> “User Administration” in the menu to enter the following
interface.
Chapter 9-7
Settings
1) Modify password
You can modify your own password.
a) Select the current user, and then click “Modify Password”, the following
dialog box will display.
b) Enter the required information in the edit boxes.
c) Click “OK” to save the change and close the dialog box.
Chapter 9-8
Settings
 The password cannot be null, and 12 characters can be entered at most.
2) Create new user
a) Click “Add”, the following dialog box will display.
b) Enter the “User Name”, “Name” and “Password” information.
c) Select user group of the user.
d) Click “OK” to save the change and close the dialog box.
 The user name cannot be null, and 12 characters can be entered at most.
 The name cannot be null, and 20 characters can be entered at most.
 The password cannot be null, and 12 characters can be entered at most.
3) Delete user （for administrators only）
Select a user and then click “Delete” to delete it.
Chapter 9-9
Settings
 The current login user cannot be deleted.
 Normal user can create new normal user, but cannot deleted any user.
9.4 Ref. Range Setup
Click “Setup” -> “Ref. Range ” in the menu to enter the following interface.
9 factory reference groups and 3 customized reference groups are provided for
your choice. Each laboratory shall select a proper reference range of its own
based on its patient demographics. The reference range differs among races,
genders, ages and geographic locations.
1) Setting as current reference group
Click “Group” enter below interface, then select one of the reference group.
Click “OK”, the selected reference group can be restored to the current one.
Chapter 9-10
Settings
2) Modify reference range（for administrators only）
To modify the reference range of current reference group, enter the cell of
upper and lower limits in the table.To restore the reference ranges to default,
you can click the “Default” button.
3) Export（for administrators only）
Click “Export”button,the the current saved reference range will be saved to
 The normal user can only choose the different reference group,but can’t
modify the reference range for each item .
 The normal user can’t export the reference range.
Chapter 9-11
Service
Chapter 10 Service
10.1 Introduction
Preventive and corrective maintenance procedures are required to keep the
analyzer in a good operating condition. This analyzer provides multiple
maintenance functions for this purpose.
This chapter introduces how to use the provided functions to maintain and
troubleshoot your analyzer.
 All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
 The reagents are irritating to eyes, skin and airway. Wear proper personal
 Improper maintenance may damage the analyzer. Operators must follow the
Chapter 10-1
Service
instruction of this manual to perform maintenance operations.
 For any questions, contact Longcarecustomer service department.
 Only Longcare-supplied parts can be used for maintenance. For any questions
, contact Longcarecustomer service department.
 Avoid contact with the sharp sampling probe when performing maintenance.
The following table lists the tools that may be used in maintenance.
No. Tools
1 Cross-headed screwdriver
2 Slotted head screwdriver
3 Medical gloves
4 Alcohol
10.2 Maintenance
Click “ Service ” -> “ Maintenance ” -> in the menu to enter the following
interface.
Chapter 10-2
Service
10.2.1 Replace LH Lyse or Diluent
Click the “Replace LH Lyse” or “Replace Diluent”button can do the reagent
replacement.
You should replace the reagent as below condition:
1) There are bubbles in reagent tube.
2) Reagent was polluted.
3) Reagent was run off.
Changing reagents procedures are:
1) Click “ Replace LH Lyse”/“Replace Diluent button.
2) All the buttons become gray, when the process is going on.
Chapter 10-3
Service
3) The buttons will go normal once replacement is done.
10.2.2 Rinse Impedance Channel
Click the “Rinse Impedance channel” button can do the impedance channel rinse
procedures.
You should rinse the impedance channel under below condition:
1) Blank testing background was over the limit.
2) The impedance counting parts and pipeline was polluted.
“Rinse Impedance Channel” procedures are:
1) Click “Rinse Impedance channel” button.
2) All the buttons appear to gray,when the process is going on.
3) The buttons will go normal once rinse was done.
4) If the fault can’t be remove by do this procedures several times,you can do
the “Soak Chamber ”procedures.
10.2.3 Flush Aperture
Click the “Flush Aperture” button can do the flush aperture procedures.
You should flush aperture under below condition:
1) The aperture was clogged.
“Flush Aperture” procedures are:
Chapter 10-4
Service
1) Click “Flush Aperture” button.
3) The times of procedures execute is depend on the severity of clogging.
5) If the fault can’t be remove by do this procedures several times,you can do
the “Soak Chamber ”procedures.
10.2.4 Soak Chamber
Click the “Soak Chamber” button ,follow the instructions aspirate the probe
cleaner by press the aspirate key can do the chamber soaking procedures.
You should soak chamber under below condition:
1) “Rinse Impedance Channel”couldn’t remove the fault.
2) “Flush Aperture”couldn’t remove the fault.
3) Impedance counting parts and pipeline occurred refractory pollution.
“Soak Chamber” procedures are:
1) Click “Soak Chamber” button,follow the instructions aspirate the probe
cleaner by press the aspirate key twice;
4) If the problem can’t be remove by do this procedures several times,you
should contact our customer service department .
Chapter 10-5
Service
10.2.5 Pack up & Storage
Click the “Pack up & Storage” button ,you can do the drain procedures.
You should drain the analyzer under below condition:
1) The analyzer will not to be used for over 2 weeks or will be storage .
2) The analyzer will be shipment or moving.
“Pack up & Storage” procedures are:
1) Click “Pack up & Storage” button,then click “yes”to close the dialog box.
2) The analyzer start drain the pipeline.
5) The buttons will go normal once procedures was done.
4) Take out the pipeline from Diluent container which connecting to the
“DILUENT” joint in the rear side of the analyzer.
5) Take out the pipeline from Waste container which connecting to the “WASTE”
joint in the rear side of the analyzer.
6) Take out the pipeline from “LH LYSE” container in the left side reagent bin of
the analyzer.
7) Pack up the pipelines separately, avoid bent,dust and polluted.
8) Cover the remaining Diluent and LH Lyse with the bottle cap and screw tightly.
Store and safekeeping them in accordance with the corresponding instructions.
The user should establish and implement effective storage measures, to avoid
Chapter 10-6
Service
deterioration, misuse and accidental eating of reagent. The storage of reagents
should avoid strong cold/hot environment;
9) If the analyzer needs to be shipping or moving,take off right-side panel and fix
the sampling unit with cable tie,than put back right-side panel.
 This software can still be used after the pack up.
10.3 Viewing Logs
Click “Service” -> “System Log” in the menu to enter the following interface.
You may view the fault information, parameter modification information and
records of daily operation in the log.
Chapter 10-7
Service
The “System Log” interface records all activities of the analyzer. It contributes
significantly to searching for operation history and troubleshooting the analyzer.
 The oldest record will be overwritten automatically when number of log
records reaches the utmost.
 Records of two years can be stored at most.
 Exporting logs
1) Click “Export”, the following dialog box will display.
2) Select the range of the logs that you want to export.
3) Click “OK” to close the dialog box and export the logs.
Chapter 10-8
Troubleshooting
Chapter 11 Troubleshooting
11.1 Introduction
This chapter contains information that is helpful in locating and correcting
problems that may occur during operation of your analyzer.
 This chapter is not a complete service manual and is limited to problems that
are readily diagnosed and/or corrected by the user of the analyzer.
11.2 Fault Information and Handling
During the operation, if fault(s) is detected, the analyzer will beep and display the
corresponding fault message in the fault information area at the bottom right of
the interface. Meanwhile, the indicator will turn red.
The following figure is the fault Message dialog box.
Chapter 11-1
Troubleshooting
The name and troubleshooting method of the faults are displayed. Names of the
faults are displayed by the order of their occurrence.
You may click to select the fault, and view its troubleshooting information in the
fault help box. The troubleshooting information of the first fault is displayed by
default. Please follow the fault help to resolve the fault by sequence.
The following functions are provided:
1) Fault Clearing
Click the “Fault Clearing” button to clear all the faults that can be removed
automatically. For the faults that cannot be removed automatically, follow the
troubleshooting method to solve them.
2) Close the fault information dialog box
Click “Close” to close the dialog box, but the faults will still be displayed in
the fault information area on the interface. Click the fault information area
again, the dialog box will be displayed.
The possible fault(s) and the corresponding troubleshooting information are
listed below.
Fault Name Possible Causes Actions
 Check whether there is diluent in

Diluent ran out/
the diluent container.
Diluent empty Diluent tube was
 If there is no diluent, replace with a
clogged
new bucket of diluent. Click “Fault
Chapter 11-2
Troubleshooting
Clearing” to clear the fault
automatically.
 If the fault still exists after replacing
the diluent, contact our customer
service department.
 Check whether there is LH Lyse in
the reagent container.
 If there is no LH Lyse, replace with a
new bucket of LH Lyse. Click “Fault

LH Lyse ran out / LH
LH Lyse empty Clearing” to clear the fault
Lyse tube was clogged
automatically.
 If the fault still exists after replacing
the LH Lyse, contact our customer
service department.
 Check the waste container Is full or

Waste container full
not.
Waste full /waste sensor is
 If the fault still exists, contact our
broken
customer service department.
Chapter 11-3
Troubleshooting
 Click “Fault Clearing” to clear the
fault automatically.
 If the fault still exists, click“Service”

HGB
HGB blank voltage -> “ maintenance ” -> “ Soak
background
jump Chamber ” to aspirate the probe
abnormal
cleaner to remove the clog.
 Click “Fault Clearing” to clear the
fault automatically.
 If the fault still exists, click“Service”

WBC clogging
-> “ maintenance ” -> “ Soak
or RBC Aperture clogging
Chamber ” to aspirate the probe
clogging
cleaner to remove the clog.
If there is any other fault(s), the processing method should be based on the
software prompt.
Chapter 11-4
Specifications
Appendix A Specifications
A.1 Classification
According to the 98/79/EC, the analyzer belongs to in vitro diagnostic medical
device. It was classified into Others device, not in annex II and not for self-testing,
not for performance evaluation.
A.2 Reagents
Diluent \
LH Lyse \
Probe cleaner \
E-Z cleaner \
A.3 Applicable Tubes
The following tubes can be used:
1) Ф12~15×75mm evacuated collection tube (without cap) for whole blood
mode.
2) Ф11×40mm (1.5ml centrifugal tube) for predilute and capillary whole blood
mode.
Appendix A-1
Specifications
A.4 Parameters
Default
Parameter Name Abbreviation
Unit
White Blood Cell count WBC 109 / L
Granulocyte number GRAN# 109 /L
Granulocyte percentage GRAN% %
Lymphocyte number LYM# 109 /L
Lymphocyte percentage LYM% %
Middle cell number MID# 109 /L
Middle cell percentage MID% %
Red Blood Cell count RBC 1012/ L
Hemoglobin Concentration HGB g/L
Mean Corpuscular Volume MCV fL
Mean Corpuscular Hemoglobin MCH pg
Mean Corpuscular Hemoglobin Concentration MCHC g/L
Red Blood Cell Distribution Width - Coefficient of Variation RDW-CV %
Red Blood Cell Distribution Width - Standard Deviation RDW-SD fL
Hematocrit HCT %
Platelet count PLT 109 / L
Appendix A-2
Specifications
Default
Parameter Name Abbreviation
Unit
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW None
Plateletcrit PCT %
Platelet larger cell ratio P_LCC 109 / L
Platelet larger cell count P_LCC %
RBC
Red Blood Cell Histogram None
Histogram
PLT
Platelet Histogram None
Histogram
WBC
White Blood Cell Histogram None
Histogram
A.5 Sampling Features
A.5.1 Sample Volumes Required for Each Analysis
Refers to all terms present in the calibration curve expression with the exception of
concentration and reactivity.
Whole blood mode ≤10μL
Predilute mode ≤20μL
Appendix A-3
Specifications
A.5.2 Throughput
≥60 samples/hour
A.6 Performance Indicators
A.6.1 Display Range
WBC 0.0×109/L～999.9×109/L
RBC 0.00×1012/L～18.00×1012/L
HGB 0 g/L～300g/L
PLT 0×109/L～9999×109/L
HCT 0%~80%
A.6.2 Background/Blank Count
Parameter Background/Blank Count Requirements
WBC ≤ 0.2×109 / L
RBC ≤ 0.02×1012/ L
HGB ≤1g/L
PLT ≤ 10×109 / L
Appendix A-4
Specifications
A.6.3 Linearity Range
Param Deviation Range Linearly Dependent

Linearity Range
eter (Whole Blood) Coefficient r
0.0×109/L～10.0×109/L ≤±0.3×109/L
WBC ≥0.990
10.1×109/L～100.0×109/L ≤±5％
0.10×1012/L～1.00
≤±0.05×1012/L
×1012/L
RBC ≥0.990
12
1.01×10 /L～8.00
≤±5％
12
×10 /L
0 g/L～70 g/L ≤±2g/L

HGB ≥0.990
71 g/L～250 g/L ≤±2％
0×109/L～100×109/L ≤±10×109/L
PLT ≥0.990
9 9
101×10 /L～1000×10 /L ≤±8％
A.6.4 Accuracy
Parameter Detection Range Relative deviation/%
WBC 3.5×109 /L～9.5×109 /L ≤±5.0
RBC 3.8×1012 /L～5.8×1012 /L ≤±2.0
HGB 115 g/L～175 g/L ≤±2.0
PLT 125×109 /L～350×109 /L ≤±8.0
Appendix A-5
Specifications
HCT 35%～50% ≤±3.0
MCV 82 fL～100 fL ≤±3.0
A.6.5 Precision
Whole Blood Precision

Parameter Detection Range
(CV/absolute deviation d)
WBC 3.5×109/L～15.0×109 / L ≤2.0%
RBC 3.00×1012 / L ~ 6.00×1012 / L ≤1.5%
HGB 100 g/L ~ 180 g/L ≤1.5%
100×109 / L ~ 149×109 / L ≤6.0%

PLT
150×109 / L ~ 500×109 / L ≤4.0%
HCT 35%～50% ≤2.0%
MCV 70 fL～120 fL ≤1.0%
A.6.6 Carryover
Parameter Deviation Requirements
WBC ≤0.5％
RBC ≤0.5％
HGB ≤0.6％
PLT ≤1.0％
Appendix A-6
Specifications
A.7 Input/Output Device
 Be sure to use the specified devices only.
 If the analyzer is to be connected with LIS, the PC must be configured with dual
network cards.
A.7.1 External Computer (Optional)
Recommended PC configurations: CPU Intel® 1.6GHz and above
RAM: 1G or above
Hard disk: 160GB or above
Recommended resolution of the display: 1280*1024 (standard), 1680*1050 (wide
screen) Operating system: Microsoft Windows 7 or above, with DVD-ROM.
A.7.2. Keyboard (Optional)
101-Key alpha-numeric keyboard
Appendix A-7
Specifications
A.7.3. Mouse (Optional)
A.7.4. External Barcode Scanner (Optional)
A.7.5. Printer (Optional)
A.8 Interfaces
4 USB ports and 1 network port.
A.9 Power Supply
Voltage Input power Frequency
Analyzer 100V～240V AC 120VA 50Hz/60Hz
A.10 EMC Description
Do not use this device in close proximity to sources of strong electromagnetic
radiation (e.g. unshielded intentional RF sources), as these may interfere with the
proper operation.
This equipment complies with the emission and immunity requirements of the EN
61326-1:2013 and EN 61326-2-6:2013.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
Appendix A-8
Specifications
 It is the manufacturer’s responsibility to provide equipment electromagnetic
compatibility information to the customer or user.
 It is the user’s responsibility to ensure that a compatible electromagnetic
environment for the equipment can be maintained in order that the device will
perform as intended.
A.11 Sound Pressure
Maximal sound: 65 dBA
 Be sure to use and store the analyzer in the specified environment.
A.12 Operating Environment
Optimal operating temperature: 10℃～35℃
Optimal operating humidity: 20%～85%
Atmospheric pressure: 70kPa～106kPa
A.13 Storage Environment
Ambient temperature: -20℃～40℃
Relative humidity: 10%～90%
Atmospheric pressure: 50kPa～106kPa
Appendix A-9
Specifications
A.14 Dimensions and Weight
Width(mm) ≤ 285
Height (mm) ≤ 375 (without foot)

Dimensions
Height (mm) ≤ 390 (with foot)
Depth (mm) ≤ 390
Weight ≤ 18Kg (Net weight)
A.15 Safety Classification
Overvoltage category: II
Pollution degree: 2
Means of protection: Class I
Appendix A-10
Appendix B Hazardous Substances
Hazardous substances
Parts name
Pb Hg Cd Cr(VI) PBB PBDE
shell 〇〇〇〇〇〇
PCBA ×(1) 〇〇〇〇〇
sheet
〇〇〇〇〇〇
metal parts
machining
〇〇〇〇〇〇
part
plastic
〇〇〇〇〇〇
Host pieces
metal
〇〇〇〇〇〇
pieces
connection
〇〇〇〇〇〇
cable
fluid path
componen 〇〇〇〇〇〇
ts
Accesso Labels 〇〇〇〇〇〇
ries Closure
〇〇〇〇〇〇
assembly
Maintenan
〇〇〇〇〇〇
ce tools
Probe wipe
〇〇〇〇〇〇
block
Packaging
Package 〇〇〇〇〇〇
materials
〇: means the content of the hazardous substance in all homogeneous
materials of the part is in the limited requirement according to the
standard of SJ/T 11363-2006.
×: means the content of the hazardous substance in at least one of the
homogeneous materials of the part is beyond the limited requirement
according to the standard of SJ/T 11363-2006.
1）some parts of the circuit board used lead solder during processing.
Notice: the product marked with “×” is because there has no other
technologies or parts to be replaced at present stage, under normal use
conditions, leak and mutation will not occur in 5 years, and it will not
cause environment pollution or harm to people and property.

DC-30 Auto Hematology Anazlyer Operational Manual-ILONGCARE

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

DC-30 Auto Hematology Anazlyer Operational Manual-ILONGCARE

Uploaded by

Copyright:

Available Formats

Auto Hematology Analyzer

Product Name: Auto Hematology Analyzer

This product primarily comprises the reagent and sample

loading units and mixing systems, photoelectric

unit, control unit and data processing system

This product is applicable for detecting the parameters of

Application: blood or capillary blood, as well as WBC 3-part differential

analysis and WBC counting

Date of Manufacture: See the nameplate of the instrument

Manual Revision Date: Jan 01, 2023

strictly as instructed in this manual.

Who Should Read This Manual

This manual contains information written for clinical laboratory professionals or

trained doctors, nurses or laboratory technicians to:

1) Learn about hardware and software of the analyzer.

2) Set system parameters.

3) Perform daily operations.

4) Perform system maintenance and troubleshooting.

How to Find Information

the information you need.

If you want to… Please refer to…

Learn about the process of sample

If you want to… Please refer to…

Learn about the basic requirements of Chapter 7

Learn about the basic requirements of Chapter 8

You will find the following symbols in this manual:

Alerts the operator to follow the statement below

Alerts the operator to follow the statement below

the symbol while in operation, otherwise it may

Alerts the operator to follow the statement below

Alerts the operator to follow the statement below

Consult accompanying documents.

Authorized representative in the

The following definition of the WEEE

For in vitro diagnostic use

Product serial number

Be careful of the sampling probe tip

Consult the operation manual

CE marking. The device is fully in

SUNGO Europe B.V.

5.5.2 Sample Analysis .......................................................................................................8

Appendix A Specifications ..................................................................................... 1

Chapter 1 Safety and Precautions

no way indicative of importance and all symbols are of equal importance.

1) Keep away from the sharp parts of the analyzer, such as

sampling probe tip, reagent probe tip and stirrer in case

2) Do not touch the moving parts, such as sampling probe,

reagent probe, stirrer and fan when the analyzer is

1) Front, side and back covers mustn’t be opened when

the power is on, except by authorized service personnel.

2) Do not splash liquid on the analyzer’s worktop. In case

contact Longcareor its local distributors immediately.

3) Keep away from the inside of computer and printer in

case of high voltage.

1) All test samples, calibrators, controls, etc., should be

considered contagious and protective gloves should be

worn when coming into contact with these objects.

2) All waste liquid should be considered contagious and

protective gloves should be worn when coming into

contact with it.

3) Parts that have contacts with samples, such as sampling

probe, reagent probe, stirrer, cuvette, waste liquid tubing

and waste liquid container should be regarded as

clinical chemistries in serum, plasma, urine and cerebrospinal fluid 　

The analyzer can only be operated by personnel who have trained 　

anyone can directly disconnect the power of the instrument or the 　

modified, please contact Longcareor the authorized Longcare 　

Perform calibration for different batches of reagents. Incorrect 　

analysis parameters can lead to wrong test results. Please consult 　

found, contact Longcarecustomer service department or your local distributor 　