DC-30 Auto Hematology Anazlyer Operational Manual-ILONGCARE
DC-30 Auto Hematology Anazlyer Operational Manual-ILONGCARE
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.
Model: DC-30
Scope of Product WBC, RBC, PLT, HGB, etc. in anti-coagulated venous whole
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
This manual contains 11 chapters and 2 appendices. Refer to the table below to find
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
II
Introduction
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
Symbols Meaning
III
Introduction
You may find the following symbols on the analyzer, reagent, QC or calibrator:
Symbols Meaning
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
IV
Introduction
Symbols Meaning
Batch code
Expiry date
Date of manufacture
Manufacturer
Temperature limitation
V
Introduction
Symbols Meaning
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
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
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
1.1 Safety
Bodily Injury
of body injury.
running.
Electric Shock
liquid gets into the analyzer, turn off the power and
Chapter 1-1
Safety and Precautions
Biohazard
1.2 Precautions
Intended Use
Chapter 1-2
Safety and Precautions
Operator
If the instrument has dangerous failure, such as fire, odor, smoke, etc.,
Operating Environment
analyzer damage.
Electromagnetic Interference
Chapter 1-3
Safety and Precautions
the analyzer.
Improper Grounding
electric shock.
Liquid Leakage
discharge volume.
Probe Obstruction
Carefully check reagents and samples and make sure they do not
Chapter 1-4
Safety and Precautions
Water Quality
Device Connection
analyzer.
Analysis Parameters
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
immediately.
personal injury or damage your analyzer. Do not install your analyzer without
2.2 Installer
and space for the installation. When the analyzer needs to be relocated, please
Chapter 2-1
Installation
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:
If you notice any of the above instances of damage, please immediately notify
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
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.
Check the site for proper space allocation. In addition to the space required for the
2) at least 50cm between the left and right side door of the analyzer and the walls,
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
The diluent container shall be put within 1.0m under the analyzer, LH Lyse
Chapter 2-3
Installation
The worktop (or the floor) where the analyzer is placed shall be able to
Before turning on the analyzer, make sure the input voltage meets the
requirements.
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
Please connect the analyzer with the original power cable. Using other power
Chapter 2-4
Installation
of this analyzer.
Do not place the analyzer near brush-type motors, flickering fluorescent lights,
wind.
Chapter 2-5
Installation
personal injury or damage your analyzer. Do not install your analyzer without
Moving analyzers should follow the appropriate local safety regulations and
Before the analyzer is shipped out, the sampling probe is fixed by a plastic
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
procedures.
5) If any of the pipes or fluidic components is worn out, stop using the analyzer
or replacement.
6) Check and make sure the pipes of reagents, including diluent, LH Lyse and
7) You must only use the Longcare-specified reagents, otherwise the analyzer
8) Pay attention to the expiration dates and open-container stability days of all
Chapter 2-7
System Description
3.1 Introduction
menus, software help system, operation information and reagent system of the
3.2 Parameters
Parameter
Name Abbreviation
Group
Chapter 3-1
System Description
Parameter
Name Abbreviation
Group
Hematocrit HCT
Plateletcrit PCT
)
Chapter 3-2
System Description
Name Abbreviation
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,
Chapter 3-3
System Description
1-- Aspirate key 2-- sampling probe 3-- Probe wipe block
Chapter 3-4
System Description
The status indicator is on the front of the analyzer. It indicates the ready, running,
The indicator illuminates in 4 colors to indicate the current status of the analyzer.
Chapter 3-5
System Description
Sleeping,can be wake up at
Whole blood mode sleep Green light shining
any time
Sleeping,can be wake up at
Predilute mode sleep Blue light shining
any time
Sleeping,can be wake up at
Sleep with fault Red light shining
any time
3.3.2 Buzzer
The buzzer indicates faults of the analyzer or reminders sampling was finished.
Chapter 3-6
System Description
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.
The sampling probe is on the front of the analyzer. It is used to aspirate blood
The aspirate key is located behind the sampling probe. Press it to start analysis,
The touch screen is on the front of the analyzer. You can use it to perform interface
Chapter 3-7
System Description
1) Power interface
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
The thermal printer is on the left of the analyzer for printing reports . The external
The supported external printer models are: HP Laser Jet P1008,HP Laser Jet
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
As the analyzer, reagents (diluent, LH Lyse, probe cleaner and E-Z cleaner), controls,
(see Appendix A Specifications), which are formulated specifically for the fluidic
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
Each reagent package must be examined before use. Product integrity may be
compromised in packages that have been damaged. Inspect the package for signs
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
Chapter 3-9
System Description
Pay attention to the expiration dates and open-container stability days of all
3.4.1 Reagents
1) Diluent
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
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
whole-blood products used to calibrate the analyzer. Store and use the controls
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
Chapter 3-11
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
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
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.
This analyzer can process two types of blood samples - whole blood samples and
Chapter 4-1
Working Principles
predilute samples.
Chapter 4-2
Working Principles
Chapter 4-3
Working Principles
The WBC/HGB dilution is delivered to the HGB bath where it is bubble mixed with a
that is measurable at 530nm. An LED is mounted on one side of the bath and emits
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
RBC/WBC/PLT are counted and sized by the electrical impedance method. This
Chapter 4-4
Working Principles
pathway. As each particle passes through the aperture, a transitory change in the
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
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
Chapter 4-5
Working Principles
1) RBC
2) MCV
Based on the RBC histogram, this analyzer calculates the mean cell volume
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows:
��� × ���
HCT =
10
���
MCH =
���
���
MCHC = × 100
���
4) RDW-CV
5) RDW-SD
1) WBC
Chapter 4-6
Working Principles
Based on the WBC histogram, this analyzer calculates the number (109/L) and
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
the platelet size distribution. Each PDW result is derived from the platelet
4) PCT
��� × ���
PCT =
100000
Chapter 4-7
Basic Operations
5.1 Introduction
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
gloves, lab coat, etc.) and follow safe laboratory procedures when handling
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
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
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
Check if the reagent tubes are properly connected before using the analyzer.
silica glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary
tubes.
blood collection tube, anticoagulant collection tubes and capillary tubes etc.
Chapter 5-2
Basic Operations
2) Checking reagents
Check to see if the reagents are expired or frozen. Reagents must stand for 24
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
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
4) Enter the current user name and the password respectively into the “User
Chapter 5-3
Basic Operations
If the software cannot be started successfully after being launched for several
distributors.
The user name and password may be consisted of 1-12 letters, and the
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.
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
Running sample with the background abnormal fault present will lead to
unreliable results.
Perform daily quality control before running any samples. See Chapter 7 Quality
All the samples, controls, calibrators, reagents, wastes and areas contacted
Chapter 5-5
Basic Operations
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
The sampling probe is sharp and potentially biohazardous. Do not contact the
Do not reuse disposable products such as collection tubes, test tubes, capillary
Make sure the probe tip does not contact the sample tube to avoid potential
spillage.
The analyzer can run 2 types of samples: whole blood samples and predilute
samples.
Chapter 5-6
Basic Operations
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
the interface.
d) Add 20μL of venous blood or capillary blood to the diluent, close the tube
e) Click “Cancel” after preparing all the samples, the analyzer will clean the
Chapter 5-7
Basic Operations
After mixing the capillary sample with the diluent, be sure to wait 3 minutes
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.
Click “Analysis” to enter the sample analysis interface. Click “Sample Mode”
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
a) Entering the ID
Select patient gender from the “Gender ” pull-down list. There are two
Chapter 5-9
Basic Operations
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.
Select patient type from the “Patient Type” pull-down list. There are four
Examination”.
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.
Enter the number of the patient’s bed into the “Bed No.” box.
Chapter 5-10
Basic Operations
Enter the time when the sample is collected into the “Sampling Time”
box.
Enter the delivery time of analysis into the “Send Time” box.
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).
m) Entering comments
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
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
Chapter 5-11
Basic Operations
3) Aspirating sample
Present the sample to the sampling probe. Press the aspirate key to start the
analysis.
The sampling probe will automatically aspirate sample. When you hear
The analyzer will automatically run the sample. When the analysis is finished,
Chapter 5-12
Basic Operations
During the analysis, if faults like clog or bubble occur, the analyzer will
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
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.
3) 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).
questionable.
If you see “*****”in the result, it means the result is invalid or out of the
Chapter 5-14
Basic Operations
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.
When the WBC histogram is abnormal, some words such as “R1, R2, R3, R4, Rm”
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
R2: It indicates that there are abnormalities between lymphocyte peak and
intermediate cell area, and that there may be atypical lymphocyte, plasma cell,
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,
R4: It indicates that there are abnormalities in the right side of the neutrophil peak,
When the PLT histogram is abnormal, the word "Pm" will appear on the right side of
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.
Flag
Flag Meaning Judgment criterion
Type
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
Flag Meaning Judgment criterion
Type
All decrease WBC, RBC and PLT low RBC < 3.5×1012/L
Possible presence of
microcyte, macrocyte,
The distribution of RBC
RBC abnormity anisocytosis, RBC
histogram is abnormal
agglutination and
RBC
dimorphic histogram
Flag
Chapter 5-17
Basic Operations
Flag
Flag Meaning Judgment criterion
Type
Flag
PLT increase PLT high PLT > 600×109/L
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.,
Refer to Section 9.2.4 Maintenance Setup for how to edit waiting time before
Chapter 5-18
Basic Operations
Under sleep status, if there are unfinished printing or communication tasks, the
1) Aspirate key
2) Touch screen
When exiting from the sleep status, the analyzer will perform different
If fault occurs when the analyzer is exiting from the sleep status, see Chapter 3
After exiting the sleep status, the analyzer will resume its original status. And
5.7 Shutdown
1) Click the shutdown button on the menu and the following shutdown dialog
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.
government regulations.
Do not start up the analyzer immediately after it is shut down. Wait for at least
10 seconds.
Chapter 5-20
Basic Operations
perform the shutdown procedure to shut down the analyzer after it has been
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
Chapter 5-21
Reviewing Results
6.1 Introduction
The analyzer automatically saves analysis results. You can review all the analysis
Operators can review, validate, search, edit and export saved results on the
Chapter 6-1
Reviewing Results
The table area lists all analyzed samples, including basic sample information like
The table area displays the latest sample results at the top.
Chapter 6-2
Reviewing Results
Select one or more sample records on the table data interface, click “Check”,
2) Cancel Check
Select one or more checked sample records at the table data interface, click
Chapter 6-3
Reviewing Results
3) Click “Yes” to delete the record, and the dialog box will be closed.
Click the desired sample result and it will be highlighted. Click the “ Edit Info ”
You may edit the sample and patient information, and click “OK ” to save the
Chapter 6-4
Reviewing Results
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
6.2.7 Search
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
6.2.9 Transmission
software.
Chapter 6-6
Reviewing Results
Chapter 6-7
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.
intervals. Analysis of the results with statistical methods allows the inference that
sample results are reliable. Longcarerecommends you run the QC program daily
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
All the samples, controls, calibrators, reagents, wastes and areas contacted
Chapter 7-1
Quality Control
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
Keep your clothes, hairs and hands away from the moving parts to avoid injury.
The sample may spill from the uncapped collection tubes and cause biohazard.
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 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.
Do not reuse disposable products such as collection tubes, test tubes, capillary
control samples to see if there is any agglutination, if yes, process the samples
Chapter 7-2
Quality Control
Use the controls and reagents specified by Longcareonly. Store and use the
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.
blood collection tube, anticoagulant collection tubes and capillary tubes etc.
7.2 L-J QC
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
“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
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
10) Enter the target and limits in the edit boxes according to the package insert of
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.
2) Click “Absolute value” to display the limits in the form of absolute value, or
You can select one of the two ways below to run controls:
2) Put controls together with normal samples, and run the controls under the
From Way A
After editing the QC information, you can start QC analysis by whole blood or
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
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
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
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
5) When analysis finishes, the QC results will be displayed in the current interface
Chapter 7-7
Quality Control
After QC analysis, you can review the QC results in the following ways.
1) QC Graph
2) QC Table
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.
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.
Chapter 7-9
Quality Control
Export
2) The system will detect the USB and export data automatically.
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
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
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
1) Click the menu option “QC” -> “X-B QC” -> “Setup”.
3) At the X-B QC setting interface, you may activate/deactivate X-B QC, set
1) In the “Samples/Batch” edit box, you may enter the amount of samples
Chapter 7-11
Quality Control
point.
Setting target/limits
Before the X-B QC analysis, you shall set up the target and limit for each
The units of target/limit of all parameters are the same as those in the
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
In X-B QC, sample results conforming to any of the following conditions will be
Chapter 7-12
Quality Control
2) Background results;
5) Calibration data;
6) Results generated while there are faults which could affect the accuracy of the
“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
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
Chapter 7-13
Quality Control
In the sample validity setup, the upper limit shall be no smaller than the lower
The valid ranges of the RBC parameters are their linearity ranges; the valid
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:
2) Click “Absolute value” to display the limits in the form of absolute value, or
Chapter 7-14
Quality Control
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:
MCV 90 2.7
MCH 30 0.9
MCHC 340 10
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
Chapter 7-15
Quality Control
After QC analysis, you can review the QC results in the following ways.
1) QC Graph
2) QC Table
1) Click the menu option “QC” -> “X-B QC” -> “QC Graph”, the following
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.
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
Chapter 7-17
Calibration
Chapter 8 Calibration
8.1 Introduction
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
All the samples, controls, calibrators, reagents, wastes and areas contacted
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
The reagents are irritating to eyes, skin and mucosa. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
Chapter 8-1
Calibration
procedures when handling them and the contacted areas in the laboratory.
If reagents accidentally spill on your skin or in your eyes, rinse the area with
Keep your clothes, hairs and hands away from the moving parts to avoid injury.
government regulations.
Do not reuse disposable products such as collection tubes, test tubes, capillary
blood collection tube, anticoagulant collection tubes and capillary tubes etc.
administrator-level.
Use the calibrators and reagents specified by Longcareonly. Store and use the
Chapter 8-2
Calibration
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
detected during these checks, do not attempt to calibrate the analyzer. If necessary,
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.
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
4) It is recommended that you create a log table for your analyzer. This log table
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.
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
Chapter 8-5
Calibration
For example: Suppose the WBC reference value of a calibrator is 8.4, and the
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
98.90%×8.4
New factor= = 101.81%
8.16
of an invalid calibration factor, try to find out the reason (e.g. calibration
2) Enter the new calibration factors into the factor cell of the parameter that
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
system date.
b) If the entered calibration factors are invalid, a dialog box will pop up
Chapter 8-6
Calibration
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
Click the menu option “Calibration” -> “ Calibrator ” to enter the following
interface.
Chapter 8-7
Calibration
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.
1) Verify the testing mode on the analysis interface,it must be the same mode
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.
6) After the analysis, the analyzer will have different responses to different analysis
results.
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
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
Click “OK” to close the message box, and the data will be deleted from the
The valid results within the linearity range will be displayed directly.
Valid calibration results will be marked with “√” per the default setting, and
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
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
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
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:
the CV% of any parameter exceeds the reproducibility range, then the
calculated calibration factors of all parameters will not be saved and a message
Click “Yes” to close the dialog box and switch to another interface. The
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
12) Export
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
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
3) Verify the testing mode on the analysis interface,it must be the same mode
4) Select the ID of current sample from the pull-down box “Sample No.”.
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
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
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
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
Click “Yes” to close the dialog box and discard the calibration data, then
switch to another interface. The original calibration factors and calibration date
12) If the calculated calibration factors are valid, when switch to another interface,
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
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
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
accessible to operators.
Chapter 9-1
Settings
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
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
Click “Setup” -> “System Setup” -> “Print Setup” in the menu to enter the
following interface. You can set up the following contents: Print type,Print
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
3) Auto print
Select “On” or “Off”, you can choose whether automatic print the result
4) Print title
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
Click the “Local IP”, “Server IP” , "Local Mask” and “Local Gateway” edit
2) Transmission setting
Set the transfer options : whether auto transmission results after sample
Click “Setup” -> “System Setup” -> “Maint.Set” in the menu to enter the
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
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
4) Auto Sleep
the machine will go to sleep automatically. You can also setup the sleeping
Chapter 9-6
Settings
interface.
Click “Setup” --> “User Administration” in the menu to enter the following
interface.
Chapter 9-7
Settings
1) Modify password
a) Select the current user, and then click “Modify Password”, the following
c) Click “OK” to save the change and close the dialog box.
Chapter 9-8
Settings
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.
Chapter 9-9
Settings
Normal user can create new normal user, but cannot deleted any user.
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,
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
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,
The normal user can only choose the different reference group,but can’t
Chapter 9-11
Service
Chapter 10 Service
10.1 Introduction
This chapter introduces how to use the provided functions to maintain and
All the analyzer components and surfaces are potentially infectious, take
The reagents are irritating to eyes, skin and airway. 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 in your eyes, rinse the area with
Improper maintenance may damage the analyzer. Operators must follow the
Chapter 10-1
Service
Only Longcare-supplied parts can be used for maintenance. For any questions
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
3 Medical gloves
4 Alcohol
10.2 Maintenance
Click “ Service ” -> “ Maintenance ” -> in the menu to enter the following
interface.
Chapter 10-2
Service
replacement.
2) All the buttons become gray, when the process is going on.
Chapter 10-3
Service
Click the “Rinse Impedance channel” button can do the impedance channel rinse
procedures.
Click the “Flush Aperture” button can do the flush aperture procedures.
Chapter 10-4
Service
Click the “Soak Chamber” button ,follow the instructions aspirate the probe
cleaner by press the aspirate key can do the chamber soaking procedures.
Chapter 10-5
Service
Click the “Pack up & Storage” button ,you can do the drain procedures.
1) The analyzer will not to be used for over 2 weeks or will be storage .
1) Click “Pack up & Storage” button,then click “yes”to close the dialog box.
4) Take out the pipeline from Diluent container which connecting to the
5) Take out the pipeline from Waste container which connecting to the “WASTE”
6) Take out the pipeline from “LH LYSE” container in the left side reagent bin of
the analyzer.
8) Cover the remaining Diluent and LH Lyse with the bottle cap and screw tightly.
The user should establish and implement effective storage measures, to avoid
Chapter 10-6
Service
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.
Click “Service” -> “System Log” in the menu to enter the following interface.
You may view the fault information, parameter modification information and
Chapter 10-7
Service
The “System Log” interface records all activities of the analyzer. It contributes
Exporting logs
3) Click “OK” to close the dialog box and export the logs.
Chapter 10-8
Troubleshooting
Chapter 11 Troubleshooting
11.1 Introduction
This chapter is not a complete service manual and is limited to problems that
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
Chapter 11-1
Troubleshooting
The name and troubleshooting method of the faults are displayed. Names of the
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.
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
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
listed below.
Chapter 11-2
Troubleshooting
automatically.
service department.
service department.
Chapter 11-3
Troubleshooting
fault automatically.
fault automatically.
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
device. It was classified into Others device, not in annex II and not for self-testing,
A.2 Reagents
Diluent \
LH Lyse \
Probe cleaner \
E-Z cleaner \
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
Hematocrit HCT %
Appendix A-2
Specifications
Default
Parameter Name Abbreviation
Unit
Plateletcrit PCT %
RBC
Red Blood Cell Histogram None
Histogram
PLT
Platelet Histogram None
Histogram
WBC
White Blood Cell Histogram None
Histogram
Refers to all terms present in the calibration curve expression with the exception of
Appendix A-3
Specifications
A.5.2 Throughput
≥60 samples/hour
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%
WBC ≤ 0.2×109 / L
RBC ≤ 0.02×1012/ L
HGB ≤1g/L
PLT ≤ 10×109 / L
Appendix A-4
Specifications
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
0×109/L~100×109/L ≤±10×109/L
PLT ≥0.990
9 9
101×10 /L~1000×10 /L ≤±8%
A.6.4 Accuracy
Appendix A-5
Specifications
A.6.5 Precision
A.6.6 Carryover
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
PLT ≤1.0%
Appendix A-6
Specifications
If the analyzer is to be connected with LIS, the PC must be configured with dual
network cards.
RAM: 1G or above
Appendix A-7
Specifications
A.8 Interfaces
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
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
Appendix A-8
Specifications
environment for the equipment can be maintained in order that the device will
perform as intended.
Appendix A-9
Specifications
Width(mm) ≤ 285
Overvoltage category: II
Pollution degree: 2
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
1)some parts of the circuit board used lead solder during processing.
Notice: the product marked with “×” is because there has no other
conditions, leak and mutation will not occur in 5 years, and it will not