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LWD6500 User's Manual A0
LWD6500 User's Manual A0
©Shenzhen Landwind Industry Co., Ltd. All rights reserved. This manual and its contents
represent special and confidential information of Shenzhen Landwind Industry Co., Ltd
(Landwind Company below). Without written permission from Landwind Company, any
individual or organization cannot reprint, copy, modify or publish all or part of the information
to others or spread the content. The readers of this manual are the users. They are authorized to
use this manual as part of purchasing the equipment of Landwind Company. Unauthorized
Landwind Company doesn't guarantee this information in any way, including (and yet not
limited to) the implicit warranties of business and rationality using for special purposes.
Landwind Company has take measures to make sure that this documentation is correct.
However, Landwind Company won't be responsible for errors or omissions, and reserves the
right to improve any product so as to enhance the reliability, function or design of the product.
Trademark
TM
, and are the trademarks of Landwind Company. The product
Declaration
The version of this manual is A/1 and the releasing date is 2013-2. This manual may be made
Shenzhen Landwind Industry Co., Ltd reserves the right of the final say and explanation for this
instruction manual.
Preface
Thank you for purchasing Landwind's Five-differential Haematology Analyser. Here we express
our gratitude to you.
Please read this manual carefully so as to use the product properly. After reading it carefully,
please take care of it so you can refer to it when needed.
Model: LW D6500
Management category: The analyser belongs to the blood analysis system among the clinical
analytical instruments (6840). Its management category is II.
Production license number: Guangdong food and drug administration machine production
license No. 20020477
Registration certificate number: Guangdong food and drug administration machine (approved)
2012 No. 2400329
Product composition: Composed of a blood sample absorption tube, dilution device, cleaning
device, analysing and measuring device, microprocessor, computer and monitor.
Scope of application: Its purpose is to count blood cells, five-differential white blood cells and
measure the concentration of haemoglobin in the clinical tests.
Registered address: Room 408-413, Building E, Bijingyuan, Jingtian Road, Futian District,
Shenzhen
Honglong Hi-Tech Park, Liyuan Industrial Region (Landwind Science and Technology Park)
I
Symbols
Symbols Meanings
Labels and silk screens listed in the table below apply to this manual.
Symbols Meanings
Lot number
II
Expiry date
Serial number
Production date
Manufacturer
Storage temperature
Network interface
Figure
III
All the figures provided in this operation manual represent illustrations or examples only. Please do not use
them for other purposes.
IV
Table of Content
Table of Content
Preface ........................................................................................................................................................ I
1
Table of Content
2
Table of Content
4.3.1 Whole blood mode and micro-whole blood mode .................................................... 4-30
3
Table of Content
4
Table of Content
5
Table of Content
6
Manual Overview
1.1 Overview
This chapter introduces how to use this LW D6500 operation manual. This operation manual is provided with
the machine. It gives detailed information about the use, function and operation of LW D6500. Please read
and understand the contents in the manual carefully before use LW D6500 to ensure proper usage, maximal
performance and safety of the operators.
Chapter 5 Setting It introduces the settings of system parameters such as software date
format and parameters units
Chapter 6 Daily It introduces the collection and preparation methods of samples, as well
operations as sample analysis procedures and daily operations
1-1
Manual Overview
Review
Chapter 9 Calibration It introduces the basic requirements of calibration and the calibration
methods provided by LW D6500
"××" The contents in " " are the LW D6500 information displayed in the
software interface
All the figures provided in this manual represent examples only. Please do not use them for other purposes.
The diagrams, settings or data in the figures may not be completely consistent with those actually displayed
on the LW D6500.
Biological risk:
1-2
Manual Overview
Warnings:
Cautions:
Note:
Biological risk:
1. All items (samples, controls, calibrators, reagents, wastes, etc.) and regions
that come into contact with these items have the potential of biological
infection. Operators should observe laboratory safety operation rules and wear
personal protective devices (such as laboratory protective clothing, gloves,
mask, etc.) when touching relevant items and regions in the laboratory.
2. If the analyser leaks, the leaked liquid has a potential of spreading
biological infection.
Warnings:
1. Make sure to check all the doors/covers before starting instruments, and
make sure that they won't suddenly open or become loose while operating the
instrument.
2. Please take all the security measures provided by the instrument. Please do
not prohibit the use of any device or sensor that is for safety purpose.
3. Please respond and handle all warnings and failure in a timely manner.
1-3
Manual Overview
7. Please comply with the local provisions when discarding of the equipment.
Cautions:
1. Please strictly adhere to the instructions in this user's manual when using
this equipment.
1-4
Installation
Chapter 2. Installation
2.1 Overview
Warnings:
Note:
The sampling assemblies are fixed with plastic tie and binder clips when the instrument
was shipped from the factory to avoid the components from being damaged during
transportation. Cables and clips must be removed before using the instrument.
This analyser has been rigorously tested before it was shipped from the factory. The analyser has been
carefully packed before shipping to avoid any impact during transportation. Please carefully check the
packaging and see whether there is any physical damage when the analyser arrives. Please notify the
Landwind after-sales service department or regional agent in a timely manner should there be any damage.
2-5
Installation
Warnings:
2. Please ensure the input voltage meets requirements before switching on the analyser.
Cautions:
1. It is not recommended to install terminal software and database in the system disk.
2. Using a power strip may cause extra electrical interferences and lead to incorrect analysis
results. Please place the analyser near a power socket and avoid using a power strip.
3. Please use the supplied power cord. Using other power cords may damage the analyser or
lead to incorrect analysis results.
Contents Requirements
Site 1. The ground surface should be level and the operation platform must be steady and secured.
2-6
Installation
2. The environment should be dust-free, without mechanical vibration, sources of heat and
wind, pollution, loud noise source and electrical interference;
5. Do not put the equipment close to the source of electromagnetic interference to avoid
affecting the proper operation of the equipment.
1. The space reserved between the left and right doors of the analyser and the walls should be
≥100cm;
Space 2. The reserved space between the analyser back wall and the wall should ≥50cm;
3. Make sure that there is enough space on the operation platform and under the analyser to
place diluent and waste barrels;
Temperatu
15 ℃ - 30 ℃
re
Relative
10 % - 90 %
humidity
Atmosphe
ric 70 kPa - 110 kPa
pressure
Ventilatio There should be an exchange of air with the outside, adequate air flow and the source of
n wind should not blow directly towards the analysis part.
Power
supply AC 100V - 240V, input power ≤200 VA, 50/60HZ
The computer should meet the corresponding safety requirements with dual core CPU of
Computer 1.6G above and internal memory of 2.0G above. It should be pre-installed with Windows
XP/Win 7 operating system.
Electroma
gnetic Do not place it close to brush-type motor, flickering fluorescent light and electrical contact
wave device that will always be turned on and off.
The discharge of waste must comply with the requirements of local environmental protection
Waste
department.
2-7
Installation
2-8
Installation
Cautions:
Please ensure the lengths of the diluent tube and waste tube do not exceed 1500mm, and the
length of the diluent tube of all Lyse does not exceed 850mm.
2-9
Installation
2-10
Installation
Note:
The float sensor used in this equipment is only suitable for the waste barrels provided by
our company or that with the same model (for examples, used diluent barrel).
(1) Take a suitable waste barrel (the barrel can be an empty diluent barrel. Pull out the opening on the diluent
barrel to expose the barrel mouth), and open the lid;
2-11
Installation
(2) Install the waste float sensor assembly in the accessory kit according to Figure 2-6. Please keep the float
sensor in upright position during installation and tighten the lid on the sensor to prevent waste from
overflowing;
Complete the installation of the waste float sensor according to Figure 2-3 and the steps above.
Note: Please replace the waste barrel in a timely manner when the machine prompts that the waste is full to
avoid pollution and losses.
Please follow the steps above to replace the waste barrel. The replaced waste must be sealed and handled
properly to avoid pollution.
2-12
System Overview
3.1 Overview
LW D6500 Five-differential Haematology Analyser is a kind of in vitro diagnostic equipment and is used for
the counting of whole blood cells and WBCs with five-differential for human blood samples in clinical
laboratories.
Note:
This analyser is a clinical examination instrument used for filtering. Doctors are required to
consider the clinical examination results or other test results when making clinical
judgements based on the analysis results.
This analyser is suitable for counting whole blood cells and WBCs with five-differential for human blood
samples in the laboratory environment.
The analyser provides quantitative analysis results of 24 kinds of blood parameters and 4 kinds of research
parameters, 3 histograms, 1 scattergram, and 2 kinds of measuring modes: CBC and CBC+DIFF.
Parameter Abbreviations CBC CBC + DIFF
3-1
System Overview
Haematocrit HCT * *
Plateletcrit PCT * *
3-2
System Overview
Note:
1. "*" means provided in this measuring mode, and "/" means not provided in this
measuring mode.
2. ALY%, LIC%, ALY# and LIC# are research parameters and are only used in researches.
They cannot be used as the basis of clinical diagnosis. For more information about research
parameters, please refer to the research parameters in General Settings in 5.3.1.
Warnings:
1. Before operating the analyser, please ensure all the doors/covers/plates are in good
conditions and confirm that they will not be opened or loosen during operation.
2. This analyser is relatively heavy. It may cause bodily injuries if carried by only one
person. It is recommended to move the analyser by two people together if it needs to be
moved. The corresponding security procedures must be observed and appropriate tools are
needed.
Cautions:
If other software is installed or removable storage devices are used on the computer
installed with the analyser system, or the computer is used for other purposes (play games,
access the Internet, etc.), then the computer may be subject to computer viruses that may
lead to system damage or data errors. Please ensure the equipped computer is only used for
the sole purpose of the analyser system.
3-3
System Overview
The probe is sharp and may contain items with biological risks. Please
be extremely careful when working!
3-4
System Overview
7: Waste fitting
3-5
System Overview
Laser radiation exists when opened. Please do not look straight into the laser
beam or through optical instruments.
3-6
System Overview
5: Power switch
Please do not put your hands near the bottom plate for syringe guide groove to
avoid crushing injuries when the machine is running.
3.3.1 Analyser
The main part of this product is used for completing analysis and processing data.
3-7
System Overview
Cautions:
Do not turn the power on and off repeatedly in a short time to prevent the analyser
from being damaged.
3.3.5It is located at the back of the probe and is used to start the counting
3-8
System Overview
This interface can be divided into several sections according to functions as below:
1 – Interface title section
The title name of the current interface is displayed at the bottom of the interface. For examples, if "Daily
Check" is displayed, then it is currently showing " Daily Check " interface.
2 – Counting status icon
It displays the current counting status, and the display method is the same as the power/status state light on
the analyser.
The green light keeps on: Status of allowing to perform counting;
The green light flicker: Status of performing fluidics sequence. No counting allowed;
The yellow light keeps on: Non-failure status of not allowing to perform counting (for example: Sleeping
status);
The red light flickers: Failure status of not allowing to perform counting.
3 – Daily check
Display the start-up information.
4 – Status display section
It is located on the upper right of the interface. The statuses from left to right are:
Connection status of analyser and computer
Note:
When the minimization is performed, the software interface display can be restored by
clicking the software interface icon in the taskbar.
6 – System time
It displays the system time set in the current operating system. Please refer to Chapter 5 Settings for the
modification methods of the system date format.
7 – Input method button
It provides selection and display of input methods. Click the input method button and open the input method
language bar menu. The user can click the desired input method option and switch the current input method
to the expected type and then input contents.
8 – Fault information section
When any fault appears, a fault assistance dialogue box will pop up, and corresponding fault information will
display in this section. When there is more than one fault, the fault information in this area will display
alternatively, and the severity of the fault will be differentiated via different colours. From high level to low
level, the background colours in use are red, orange, blue and green in sequence. Please refer to Chapter 11
Troubleshooting for detailed troubleshooting methods.
9 - Operation/status information prompt area
This area shows the prompt information about the current operation of the analyser/computer, or the prompt
information about the status of the analyser/computer.
10 - Logged-in user information area
This area shows the user level and user name of the current logged-in users of the terminal software.
11 - Menu button
You can open the system menu by clicking Menu located at the upper left portion of the interface. Click a
menu item. If there is no " " mark at the end of this menu item, then the corresponding interface or
dialogue box will be opened; If there is a " " mark at the end of it, then the corresponding submenu of this
item will be opened. Click the submenu item, and the corresponding interface or dialogue box will be opened.
12 - Shortcut button area
3-10
System Overview
The upper area of the interface is the shortcut button area. If you click a shortcut button, it means that you've
selected this button, and you will enter the corresponding interface immediately, or a dialogue box will pop
up immediately.
13 - Non-full screen display functional area
Double click to make the interface size ideal.
Click the shortcut button and enter the sample analysis interface:
This interface can be divided into several sections according to functions as below:
Four coagulation tests, ESR, and blood type input area
3-11
System Overview
Enter the maximum and minimum of the reference value, and then click OK. The reference value then will be
stored at the right side of the input box.
Place the mouse pointer in the corresponding edit box based on the requirements. When a cursor appears in
the box, you can begin editing;
Click the arrow button to select when editing blood types as shown in the figure below:
Click the counting button to finish counting (you can edit information during the counting). Click
to save.
3-12
System Overview
Click and a dialogue box will pop up, as shown below. Click OK to restore the value
before modifying.
3-13
System Overview
3.5.2 Click
Move the pointer to the content that you want to select, press the left mouse button and then release.
Note:
If the content isn't selected, please repeat this operation; If needed, please check the
connection of the mouse. If the problem continues after checking, please contact the
after-sales department or the agent of the region of Landwind Company.
Note:
If the content isn't selected, please repeat this operation; If needed, please check the
connection of the mouse. If the problem continues after checking, please contact the
after-sales department or the agent of the region of Landwind Company.
Note:
If the content isn't selected, please repeat this operation; If needed, please check the
connection of the mouse. If the problem continues after checking, please contact the
after-sales department or the agent of the region of Landwind Company.
3-14
System Overview
3.5.6 Tab
The tab shows one-page contents among several pages of interface information. For example, click Setting
label in the L-J QC interface, enter the Setting tab, browse the information and set relevant information. The
"Setting" tab is shown below.
3-15
System Overview
3.5.7 Button
3.5.7.1 Common button
After clicking the common button, the software will perform the corresponding function as shown on the
respective button. For example, printing operation will be performed when click Print shown in the figure
below.
Click arrow button again to hide the drop-down list, as shown in the figure below.
When the drop-down list is open, you can use the [↑] and [↓] keys on the keyboard to shift the highlighted bar
to the item you want to select;
3-16
System Overview
When the drop-down list is open, you can hide the drop-down list by using the [Enter] key on the keyboard or
click any option directly. In this case, the currently selected option (highlighted item) will replace the original
contents in the combo box;
When the drop-down list is open, you can hide the drop-down list by using the [Esc] key on the keyboard. In
this case, the existing content in the combo box will remain the same.
Note:
Horizontal/vertical scroll bars will appear if the content in a list cannot be displayed fully
on the screen. The operator can drag the scroll bars or use the [PgUp] and [PgDn] keys on
the keyboard to browse complete information.
After clicking the arrow button on the date picker, a date selection box, as shown below, will pop up.
Select year: Click currently displayed year and the up and down arrow buttons will appear on the right. In this
case, click up/down arrow button to switch to the year you want to select.
Select month:
Method one: Click the left/right arrow buttons on two sides of the selected box directly to switch to the
month you desire.
Method two: Click currently displayed month, and click the month you want to select in the month list shown
bellow.
3-17
System Overview
Select date: Click the date you want to select. The date selection box is concealed. The original date in the
date picker will be replaced by the selected date (including year, month and day).
When the date selection box pops up, you can conceal it by using [Esc] key on the keyboard. The existing
content in the date picker will remain the same.
Note:
In the same setting, you can only select one radio button.
Click Press [Enter] key to switch among different fields again, and the "√" mark will disappear, which
indicates that this option is unselected, as shown in the following chart.
3-18
System Overview
Note:
In the same setting, you can only select one radio button.
In the edit box, you can also execute the following operations:
(1) Use [←] and [→] keys on the keyboard to shift the cursor;
(2) Use [Home] and [End] keys on the keyboard to shift the cursor to the left side of the first character or to
the right side of the last character.
(3) Use [Delete] key on the keyboard to delete the character on the right side of the cursor.
(4) Use [Backspace] key on the keyboard to delete the character on the left side of the cursor.
(5) Use [Tab] key on the keyboard to switch to other edit boxes.
Note:
1. Edit boxes with different uses have different requirements for characters that are allowed
to be inputted.
2. There is no need to input separators in the time edit box and IP address edit box.
3. Horizontal/vertical scroll bars will appear if the content in the edit box cannot be
displayed fully on the screen. The operator can drag the scroll bars or use [PgUp] and
[PgDn] keys on the keyboard to browse complete information.
3-19
System Overview
Note:
Horizontal/vertical scroll bars will appear if the content in the information box cannot be
displayed fully on the screen. You can drag the scroll bars or use [PgUp] and [PgDn] keys
on the keyboard to browse complete information.
You can select the combo box with reference to the operations described in the Arrow button of the combo
box chapter. If a combo box is editable, the operator can perform editing in it with reference to the operation
methods in the Edit box chapter.
3.5.12 Table
A table is composed of multiple cells, and sometimes it also contains combo boxes.
Click a certain cell and it will be selected, as is shown in the following chart.
3-20
System Overview
3-21
System Overview
Note:
1. If a table has check boxes, you can select records in certain rows/columns in the table
according to the operation methods of check box. If you do not exit the terminal software,
when you switch among each interface, the existing "√" mark will not clear.
2. If a table has check boxes, after clicking a check box, you will select or remove the "√"
mark of a record that is highlighted.
3. If you want to continuously select multiple records in a table, click the check box in front
of the start record to select it with a "√", then press the [Shift] key on the keyboard, and
click the check box in front of the end record to select it with a "√", so as to select all
records between the start record and the end record with "√".
4. Horizontal/vertical scroll bars will appear if the content in a table cannot be displayed
fully on the screen. You can drag the scroll bars or use the [PgUp] and [PgDn] keys on the
keyboard to browse complete information in a table.
3-22
System Overview
Enter the interface or dialogue box corresponding to a certain level menu item
Directly click the menu item you want to select.
Enter the interface or dialogue box corresponding to a certain submenu item
Click the relevant first-class menu item of the submenu item, and then click the submenu item.
Close menu
Click Menu to close the system menu.
If there is no "+" mark or "-" mark in front of the directory item, it indicates that there is no sub-directory for
this directory item. Clicking the directory item will display its related information directly;
Use [↑] and [↓] keys on the keyboard to shift the highlight line to the directory item you want to select;
Use [Home] or End] keys on the keyboard to shift the highlight line to the first directory item or to the last
directory item;
Using the [Enter] key on the keyboard can display sub-directories of a certain directory item. If the directory
item does not have sub-directories, directly display its relevant information;
If the sub-directories of a certain directory have been displayed, they can be concealed via using the [Enter]
key on the keyboard.
3-23
System Overview
Note:
Horizontal/vertical scroll bars will be present if the content in a directory tree cannot be
displayed fully on the screen. The operator can drag the scroll bars or use the [PgUp] and
[PgDn] keys on the keyboard to browse complete information.
After selecting the date you want to delete, if you click OK, the dialogue box will be closed and the relevant
deleting operation will be executed. If you click Cancel, the dialogue box will be closed without executing
any operations.
The "91/171" in the chart above indicates that there are 171 records in total and the current record is the 91th
record.
If you want to switch to the former record or to the following one of the current record, please press
or ;
3-24
System Overview
If you want to switch to the first record or to the last one, please press or ;
Click the edit box of the record switch bar, enter the relevant location number of the record you want to
browse and use the [Enter] key on the keyboard. Then the interface will switch immediately to the selected
record.
The help dialogue box displays help information of the current interface and relevant directory items
(highlighted directory items) by default.
If you want to browse other help information, please click the relevant directory item, and then you can
browse the selected help information on the right side of the interface.
You can close the help dialogue box via clicking × on its upper right corner.
3-25
System Overview
Enter the keywords you want to search, click Start or directly press the [Enter] key on the keyboard to start
searching.
3-26
System Overview
When the searching has been completed, the relevant directory item of all results that contain the keywords
will be displayed at the lower left side of the tab. The relevant help information of the highlighted directory
item will be displayed on the right side of the interface.
If you want to browse other search results, then click the corresponding directory items, so you can browse
help information on the right side of the interface.
Note:
1. For use and storage methods of a certain reagent, refer to the reagent's instructions.
2. The operator should perform background test after change diluent or Lyse, make sure that
the background value is within the normal range, and prepare for sample analysis.
3. Please ensure that reagents are used before the expiry date mentioned in the instructions.
3.7.1 Reagent
L-65D diluent
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
provide blood cells with an environment similar to that of plasma when diluting blood samples, so as to
ensure the blood cell volume be maintained during certain times and provide a conducting environment for
blood cell counts.
L-65LEO I Lyse
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
dissolve RBCs and four-part group WBCs
L-65LEO II Lyse
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
dissolve RBCs and four-part group leucocytes
L-65LH Lyse
3-27
System Overview
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product can
dissolve RBCs and measure haemoglobin.
L-65 probe cleaning fluid
Scope of application: It is applicable to Landwind Five-differential Haematology Analyser. This product is an
electrolyte solution contains sodium hypochlorite and can effectively remove protein stain. It is used for
cleaning and washing the sample injector of haematology analyser.
3-28
System Principles
4.1 Overview
This analyser applies the electrical electric impedance method to measure WBC/BASO, RBC and PLT; Use
the colorimetric method to measure HGB; Use semiconductor laser flow cytometry to determine WBC
five-differential data.
4-29
System Principles
2448μL diluent
4-30
System Principles
2460μL diluent
2440μL diluent
4-31
System Principles
2460μL diluent
Remain 2440μl
take 40μl
LEO Ⅰ:1100μL
LEO Ⅱ:90μL
About 1:307 dilution
for WBC analysis
4-32
System Principles
The blood sample is injected into the conical flow cell full of diluent through the nozzle when a certain
amount of blood cells are absorbed and treated with a specific amount of reagents. Cells are singly arranged
in line through the centre of the flow cell with the packing of diluent formed sheath liquid. When blood cells
suspended in the sheath liquid pass the laser detection area after a second acceleration, blood cells will be hit
with laser beams. The generated scattered light property is related to the cell size, cell membrane and
refractive index of internal structure of the cell. Low-angle forward scatter reflects the cell size and
high-angle forward scatter reflects the internal fine structure and particulate matter of the cell. Photodiode
receives these scattered light signals and transfers them into electrical pulses. According to these collected
electrical pulses data, you can get a two-dimensional histogram about the cell size and cell internal
information which is called scattergram as shown in Figure 4-2. The abscissa reflects the internal complexity
information of the cell and the ordinate reflects the cell volume.
4-33
System Principles
By analysing the DIFF channel scattergram, the analyser presents the Lym%, Mon%, Eos% and Neu%.
4-34
System Principles
Compare the enlarged collected electrical pulses with channel voltage threshold to which normal
WBC/BASO volume range corresponds. Figure out the number of electrical pulses in the WBC/BASO
channel where the electrical pulse amplitude is located. Therefore, all collected electrical pulses are classified
according to different channel voltage thresholds. The number of electrical pulses in the WBC/BASO channel
represents the number of WBC/BASO. The number of cells in each channel classified by the pulse voltage
amplitude determines the volume distribution of cells. This two-dimensional chart, which uses abscissa to
express cell volume and ordinate to express the relative number of cells, is the histogram, which reflects the
condition of cell colony distribution.
Derivation of WBC-related parametersThe analyser determines the lymphocytes percentage (Lym%),
neutrophils percentage (Neu%), monocytes percentage (Mon%) and eosinophils percentage (Eos%) through
analysing the DIFF channel scattergram and Lym area, Neu area, Mon area and Eos area of the diagram. And
calculate with the white blood cell count obtained by electrical electric impedance method to get the
lymphocytes number (Lym#), neutrophils number (Neu#), monocytes number (Mon#) and eosinophils
number (Eos#). The basophils number (Bas#) can be directly obtained by the electrical electric impedance
method. Units of the cells number are all 109/L.
4-35
System Principles
Lymphocytes percentage
Neutrophils percentage
Monocytes percentage
Eosinophils percentage
Lymphocytes number
L y m# W B C L y m%
Neutrophils number
N e u# W B C N e u%
Monocytes number
M o n# W B C M o n%
4-36
System Principles
Eosinophils number
E o #s W B C E o %
s
4.5.2 HGB
Haemoglobin concentration (HGB) is obtained by calculating with the following formula, and the unit is g/L.
4-37
System Principles
Compare the enlarged collected electrical pulses with channel voltage threshold to which normal RBC/PLT
volume range corresponds. Determine the number of electrical pulses in the RBC/PLT channel where the
electrical pulse amplitude is located. Therefore, all collected electrical pulses are classified according to
different channel voltage thresholds. The number of electrical pulses in the RBC/PLT channel represents the
number of RBC/PLT. The number of cells in each channel classified by the pulse voltage amplitude
determines the volume distribution of cells. This two-dimensional chart, which uses abscissa to express cell
volume and ordinate to express the relative number of cells, is the histogram, which reflects the condition of
cell colony distribution.
4.6.2 RBC
RBC
The analyser obtains the red blood cell count (RBC) through directly measuring the electric pulses to which
the RBCs correspond, and the unit is 1012/L.
Mean corpuscular volume
Calculate mean corpuscular volume (MCV) according to the red blood cell histogram, and the unit is fL.
4-38
System Principles
RBC MCV
HCT
10
HGB
MCH
RBC
HGB
MCHC 100
HCT
4.6.3 PLT
Platelet count
The analyser obtains the platelet count (PLT) by measuring the electric pulses that corresponds to RBCs, and
the unit is 109/L.
Mean platelet volume
The mean platelet volume (MPV) is calculated according to the platelet histogram, and the unit is fL.
Platelet distribution width
Platelet distribution width (PDW) is obtained from the platelet histogram, which is the geometric standard
deviation of PLT volume distribution (10 GSD).
Plateletcrit
The analyser calculates the plateletcrit (PCT) according to following formula, and the unit is %.
PLT unit is 109/L, and MPV unit is fL.
PLT MPV
PCT
10000
4.7 Cleaning
The analyser automatically cleans the components where the sample will flow through in each counting
process to ensure there is no sample left in the fluidics system.
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Chapter 5. Settings
5.1 Overview
This analyser has been initialized before shipping from the factory. The environmental parameter is system
default when the users first start up the analyser. Some parameters of the analyser can be reset to meet
different requirements in practical application.
The analyser has divided the permission levels of the operators into users and administrators (administrator
has all the permissions of users) to ensure the product settings and data security. The functions of the settings
of these two permission levels will be described below.
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5.2.1.1 Date format
The system date format can be set. The change of date format will cause the changes of all corresponding
formats of the dates displayed and printed, including sampling date, submission date, inspection date,
worklist entry date, reagent expiry date, QC date, calibration date, etc.
Enter settings
Click Date Format in General Settings to enter the Settings window.
OK Save settings Click OK to save settings of all items and close the Settings window.
Click Cancel without saving any settings and close the Settings
Cancel Cancel settings
window directly.
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Note:
New settings will not be restored or saved when switching between the Settings menu until
Apply or OK is clicked.
5.2.1.2 Auxiliary
Enter settings
Click Auxiliary in General Settings to enter the Settings window.
OK Save settings Click OK to save settings of all items and close the Settings window.
Click Cancel without saving any settings and close the Settings
Cancel Cancel settings
window directly.
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(2) Sample ID Settings
Click Auto-increment radio button to automatically increase the sample ID; Click Manual Input (barcode
scanning (not supported temporarily) or keyboard input) radio button to manually input the sample
ID."Auto-increment" is the default option of the analyser. Input the prefix of the sample ID in Prefix edit box
Note:
1. Both auto-increment and manual input support the methods of keyboard input and
barcode scanning (not supported temporarily) to enter a new number.
2. The setting of the prefix only affects the sample IDs to be tested later. The sample IDs
already tested and entered on worklist will not be affected.
3. If the prefix of the sample ID has been entered and the input mode is set as
"Auto-increment", then the prefix will automatically be displayed in the edit box of the
sample ID and allow the users to modify when the users enter/edit the information in the
future.
4. If the input mode of sample ID is set as "Manual Input (barcode scanning (not supported
temporarily) or keyboard input)", then the newly-added sample ID will be displayed as
blank by default in the worklist no matter the prefix has been set or not.
Other settings
If a new record needs to be added automatically according to the new record requirements after entering and
saving a record in the worklist, the operator can click "Automatically Jump to the Next Record after Saving
the New Record" checkbox. The selected box will be marked with "√". Selected by default in the analyser.
If jumping to the next record to be reviewed automatically after reviewing a sample result is required, the
operator can click "Automatically Jump to the Next Record after Reviewing a Sample Result" checkbox. The
selected box will be marked with "√". Selected by default in the analyser.
If switching between different information fields by pressing [Enter] is required, the operator can click
"Switch between Different Information Fields by Press [Enter]" checkbox. The selected box will be marked
with "√". It is selected by default in the analyser and support pressing [Tab] key to switch at the same time.
The dialogue box as shown below will pop up after the operator has clicked Information Field... behind this
option.
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There is a check box before each field with all the status selected by default. That means information needs to
be entered for all fields by default. The operator can cancel the "√" in checkbox when clicking one (or some)
field checkbox. It indicates that pressing [Enter] or [Tab] key will skip these fields directly when entering
information. That means the operator does not need to enter the information in these fields. But the operator
can also use the mouse cursor and reposition to these fields to enter the relevant information.
Click OK to save settings of the information field and close this dialogue box to return to the auxiliary
settings interface.
If completed records are required to be deleted automatically from the worklist every time after counting, the
operator can click Automatically Delete Completed Records in the Worklist check box. The selected box
will be marked with "√". Not selected by default in the analyser.
If the sampling date and submission date are required to be inputted automatically, the operator can click
Automatically Input Sampling Date and Submission Date check box. The selected box will be marked with
"√" and is selected by default in the analyser.
Note:
New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
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5.2.1.3 Laboratory information
When the operator logs in as a user, click Menu, select Settings, and select Laboratory Information in the
pop-up context menu to bring up a dialogue box displaying laboratory information. All the information is
shaded and only the operator can check it.
Basic operations
Click OK and then Cancel to exit "Laboratory Information" dialogue box.
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Parameter explanation
Paramete
Meanings Operations
rs
Login name Current user name In the box, enter
Login Login password of current In the box, enter
password user
Confirm In the box, enter
Confirm user password
password
Comment Indicate current user In the box, enter
information information
Basic operations
1. Input new password correctly into the Confirm and the Reconfirm edit box
3. If you want to exit from User and Password, click other buttons in the menu to switch to a
corresponding window directly.
Note:
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5.2.3 Shortcuts
When the operator logs in as a user, click Menu, select Shortcuts to bring up a dialogue box and display
short-cut code settings of department items by default.
Click on each button of the dialogue box respectively, Deliverer, Patient Type, Fee Type, Clinical
Diagnosis and Gender, to check short-cut code setting of the corresponding item.
Note:
You can check the corresponding fees of different fee types in the short-cut code setting of
Fee Type item.
Basic operations
If you want to exit Shortcuts dialogue box, click other buttons in the menu item to switch to a corresponding
window directly.
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5.3.1.1 Auxiliary
Enter settings
Click Auxiliary in General Settings to enter the Settings window.
Privilege settings
Edit the number of inspected samples.
If you want to permit users to edit and modify the number of samples with inspection result in the review
interface, the operator can click Edit the Number of Inspected Samples check box. The selected box will be
marked with "√", and it is selected by default in the analyser.
2. Edit inspection results
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If you want to permit users to edit/ restore the inspection results directly, the operator can click Edit
Inspection Results check box. It is selected when "√" is displayed in the box, and it is selected by default in
the analyser.
3. Review samples
If you want to permit users to execute operations of review and cancel review of sample results directly, the
operator can click Review Samples check box. It is selected when "√" is displayed in the box, and it is
selected by default in the analyser.
Basic operations
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings
window.
Note:
New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
Parameter explanation
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Paramet
Meanings Operations
ers
Hospital name Name of Hospital In the box, enter
Laboratory name Name of laboratory In the box, enter
Responsible Responsible person's name of In the box, enter
person hospital
Contact Phone number of hospital In the box, enter
information
Postcode Postcode of hospital In the box, enter
Instrument Model number of instrument In the box, enter
model number
Instrument name Name of instrument In the box, enter
Installing date Installing date of instrument Select installing date in date picker
After-sales After-sales contact person's In the box, enter
contact person name
After-sales Contact information of In the box, enter
contact after-sales contact person
information
Explanation and instructions In the box, enter
Comments
concerning hospital
Basic operations
1. Input needed information into the box of each parameter;
2. Click Apply to save the input information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings
window.
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Parameters in the same group display together by permutation, in which the first one is marked blue while
other parameters in the same group are shaded.
Parameter explanation
Para
Meanings Operations
meters
Unit Selection of unit Select from the dropdown list, the default unit system is
system system "China".
Automatically display In the User-defined unit system, click Take the Default Value
Read the
default units of all
default to automatically display default units of all parameters in
parameters in
value corresponding cells.
corresponding cells
Click Apply to save settings of all items without closing the
Apply Save settings
Settings window.
Basic operations
1. In the User-defined unit system, please click the parameter item of preset unit in the list and then
click the given unit option of the parameter on the right to set new parameter unit.
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
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Note:
1. Select different unit systems and the unit list under it will display different contents.
2. If you select User-defined option, you can modify the unit of each parameter.
3. If you select other options except User-defined, you can only check but cannot modify
the unit of each parameter because there is no unit option to select.
4. Units of other parameters will change as the unit of any one parameter in the same
group changes.
5. The unit of parameter MCH changes with MCHC and HGB and cannot be modified
by the operator.
6. When the parameter unit changes, the data format displayed in the list will also
experience corresponding changes.
7. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
5.3.1.4 Print
Enter settings
Click Print in General Settings to enter the Settings window.
Parameter explanation
Paramet
Meanings Operations
ers
Title Title of the printing report Input the title of the printing report in the edit box,
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Paramet
Meanings Operations
ers
which is "Blood Cell Inspection Report" by default.
Select the sheet type of Select from the drop down list, (A4, A5 and B5 paper
Sheet type
printing report supported) the default sheet type is A5.
Basic operations
1. Set the print parameter;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
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Note:
1. After the operator completes the print setting, he should preview the print renderings
of the report under the current setting and print the report after confirmation.
2. If the Flag information is displayed in the software default report template, Print Flag
check box is activated.
3. If the Flag information is not displayed in the software default template or the selected
report template is the template customized by the user, then Print Flag check box is
shaded and in the status of not-selected.
4. If the Print Reference Scope option is selected with "√" in print setting, the option
Print High and Low Alert Mark is in the status of selected and the user cannot execute
modifications on it, which means both reference scope and high and low alert mark ("↑"
or "↓") must be printed in the report.
5. If the Print Reference Scope option is selected with "√" in print setting, but the user
wishes to change the Print High and Low Alert Mark option into the status of
not-selected, which means reference scope will be printed in the report but high and low
alert marks ("↑" or "↓") will not printed, contact Landwind after-sales service
department or Landwind designated agent.
6. If the option Print Reference Scope is unselected with "√" in print setting, which
means the user chose not to print reference scope, he can arbitrarily change whether the
option Print High and Low Alert Mark is selected or not, namely, he can select
arbitrarily whether to print high and low alert marks ("↑" or "↓") or not in the print.
7. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
5.3.1.5 Communication
Enter settings
Click the Communication button in General Settings to enter Settings window.
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Parameter explanation
Parameters Meanings Operations
If you choose Not Transmit, then it will not transmit
the 3 histograms in the communication of the sample
records; If you choose Transmit in a Bitmap Way, then
Transmission way of the 3 histograms will be transmitted to the LIS/HIS
Transmission system of client terminal in the graphical format. If
histogram in the
way of
communication of sample "Transmit as Data" is chosen, then 3 histograms will
histogram
record
be transmitted to the LIS/HIS system of the client
terminal as data respectively when communication is
conducted on the sample record. The default option is
"Transmit as Bitmap".(Not supported temporarily)
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Parameters Meanings Operations
Click OK to save settings of all items and close the
OK Save Settings
Settings window.
Basic operations
1. Set communication parameters;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
Note:
1. The communication format settings in here are for data communication with the
outside (for examples, LIS system, etc.) instead of the communication between the
terminal and the instrument.
2. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
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Parameter explanation
Set a piece of Click Take as Default Value and the default reference
Take as default user-defined reference value range of the current reference group will
value group information as automatically be displayed on the form.
default value
Basic operations
1. Drag the scroll bars and click Upper Limit or Lower Limit cell of the parameters that need to be reset;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
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Note:
1. 10 groups of reference value ranges are defined for each of the 10 reference group
respectively.
2. After the reference group is selected, the upper and lower limits of the reference range
on the table will also be changed.
3. The reference value range of the 5 user-defined reference groups is the same as that of
"General Purpose" reference group.
4. After the reference value range has been changed, it will not affect the high and low
alert messages of the original counting results but only affect the high and low alert
messages of the subsequent counting results.
5. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
Set reference group
Click Set Reference Group and the following dialogue box will pop up.
Parameter explanation
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Parameters Meanings Operations
Set a piece of Click a reference group in the list to highlight it, and
user-defined reference then click Take as Default Value and name of the
Take as default group information as reference group, upper and lower age limit values, age
value
default value unit and gender of the default reference group will be
displayed in the corresponding cells respectively.
Basic operations
1. Set reference group information;
2. Click OK to save the setup information and refresh all settings values. Otherwise, click Cancel.
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Note:
1. The name and corresponding information of the 5 fixed reference groups in reference
group list cannot be modified.
2. The operator can modify the name, age range (including age and unit) and gender of
the 5 user-defined reference groups as required.
3. The reference group name input cannot be blank.
4. The reference group name input cannot be the same as the names of "General
Purpose, Male Adult, Female Adult, Child and Newborn", and names among all
user-defined reference groups cannot be duplicated as well.
Basic operations
1. Settings for each reference range are complete;
2. Click Apply to save the input information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
5.3.1.7 Research parameters
Research parameters include ALY%, LIC%, ALY#, LIC#.
Note:
1. Research parameters are only used in researches and cannot be used as the basis for
clinical diagnosis.
2. The settings of whether to display or print the research parameters, "*" flag and
declaration are effective to the display and printing of the research parameters for all
samples before and after settings.
3. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
Enter settings
Click Research Parameters in General Settings to enter Settings window.
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Parameter explanation
Print research parameters Click "Print "*" Mark” check box and the selected
and need to print "*" mark
Print "*" mark box will be marked with "√". Selected by default
in the analyser.
Print research parameters Click "Print Declaration" check box the selected
and "*" mark and also need
Print declaration box will be marked with "√". Selected by default
to display declaration ("*
indicates research in the analyser.
parameters and cannot be
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Parameters Meanings Operations
Basic operations
1. Set research parameters;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
5.3.1.8 Gain
Used for gain adjustments. Not recommended for operator to make often adjustments.
Enter settings
Click Gain in General Settings to enter the Settings window.
Parameter explanation
WBC WBC gain under whole blood Click the current cell value of "WBC" and input
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Parameters Meanings Operations
RBC gain Click the current value cell of "RBC" and input
RBC
new value of RBC gain adjustment.
WBC gain under predilution Click the current cell value of "WBC(P)" and input
WBC(P)
mode new value of WBC(P) gain adjustment.
The purpose of adjusting HGB The operator can directly input the value in "HGB
HGB channel gain is to change the Current Value" edit box or click adjustment button
background voltage of HGB. to modify HGB gain.
Click Apply to save settings of all items without
Apply Save settings
closing the Settings window.
Click OK to save settings of all items and close the
Ok Save settings
Settings window.
Click Cancel without saving any settings and close
Cancel Cancel settings
the Settings window directly.
Basic operations
1. Set gain value;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
Note:
2. New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
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Parameter explanation
Param
Meanings Operations
eters
Automatic sleep will start after Can be entered in "Waiting" edit box. The range is
Automatic the relevant operations of 15-120 minutes. The default is 15 minutes.
sleep fluidics system stop. Set the
waiting time.
Basic operations
1. Set automatic sleep time and scheduled maintenance time;
2. Click Apply to save the setup information;
3. If you want to exit from Settings, please click other buttons in the Settings menu to switch to a
corresponding window, or click OK/Cancel to save/discard the settings and close the Settings window.
Note:
New settings will not be restored or saved when switching between the Settings menu
until Apply or OK is clicked.
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5.3.2 User and password
When the operator logs in as the administrator, click Menu, select Settings and select User and Password in
the pop-up shortcut menu to bring up a dialogue box displaying the information list of all administrators and
users.
Parameter explanation
Basic operations
(1) Add new users
1. Click Add and the user basic information column in grey will become white for editing.
2. Input all the information in each edit box of new user information;
3. Click Save to save the newly-added user information and refresh the personnel list without closing the
dialogue box; All field values input in the dialogue box will be emptied and the operator can continue to
add other new users.
4. If you want to exit "User and password", click other buttons in the menu item to switch to a
corresponding window directly.
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Note:
2. Click Yes to delete the user, close the dialogue box and remove the deleted user from the personnel list;
3. If you want to exit from User and Password, click other buttons in the menu to switch to a
corresponding window directly.
Note:
(3) Modification
The current login user can modify his/her password and the modification method is the same as
that of users.
The current login user can empty his/her password and the modification method is the same as that
of users.
5.3.3 Shortcuts
You can set shortcuts for the following items:departments, Deliverer, patient type, fee type, gender and
clinical diagnosis.
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If a short-cut code has been set, then when inputting or editing information, complete information will be
displayed by inputting the short-cut code of the corresponding items above and then pressing the [Enter] key.
This replaces inputting (or selecting) the complete information. It's a short-cut operation.
Note:
5.3.3.1 Department
When the operator logs in as the administrator, click Menu, select Shortcuts to bring up a dialogue box and
display short-cut code settings of department items by default.
Basic operations
(1) Add new departments
1. Click Add and the colour of the shortcuts information column in grey will become white for editing.
2. Input all the information in each new department information edit box;
3. Click Save to save the newly added department information and refresh the personnel list without closing
the dialogue box; All field values input in the dialogue box will be emptied and the operator can continue to
add other new departments;
4. If you want to exit "Shortcuts", click other buttons in the menu item to switch to a corresponding window
directly.
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Note:
2. Click Yes to delete the department, close the dialogue box and remove the deleted department from the
department list;
3. If you want to exit "Shortcuts", click other buttons in the menu item to switch to a corresponding window
directly.
5.3.3.2 Deliverer
Click Deliverer in the "Shortcuts" dialogue box to display the short-cut code setting of the submitted items.
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Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting deliverer.
Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting patient types.
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5.3.3.4 Clinical diagnosis
Click Clinical diagnosis in the "Shortcuts" dialogue box to display the short-cut code setting of clinical
diagnosis items.
Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting clinical
diagnosis.
5.3.3.5 Gender
Click Gender in "Shortcuts" dialogue box to display the short-cut code setting of the gender items.
Basic operations
Refer to the relevant contents of "Department" for the operation of adding, editing and deleting gender.
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Chapter 6. Daily Operations
6.1 Overview
This chapter introduces the process of daily operations from the start-up to the shutdown of the analyser.
It mainly describes the operation process of sample analysis under different work modes in detail.
Note:
The sequencing of turning on the analyzer or running the software is not prescribed.
Preparation work
Daily QC
Sample
preparation
Sample analysis
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6.2 Preparation before the operation
Before turning on the analyser power, the operator must perform the following requirements to ensure
that the system is ready.
Biological risk:
All items (samples, controls, calibrators, reagents, waste, etc.), and regions that these
items have contact with potential biological infection. Operators should observe
laboratory safety operation rules and wear personal protective devices (such as
laboratory protective clothing, gloves, mask, etc.) when touching relevant items and
regions in the laboratory.
Warnings:
1. Operators have an obligation to observe the relevant provisions of the region and
country when discharging and disposing expired reagent, waste, waste samples,
consumables, etc.
2. The reagent will cause irritation to eyes, skin and mucous membranes. Operators
should observe laboratory safety operation rules and wear personal protective
equipment (such as laboratory protective clothing, gloves, surgical mask, etc.) when
touching reagent-related items in the library.
3. If the skin is flyblowed by the reagent, please wash the affected area immediately
with plenty of water and seek medical treatment if necessary. If the reagent gets to
the eyes, please wash them immediately with plenty of water and seek medical
treatment from doctor.
4. Please take a distance to keep the clothes,hair or hands from getting hurt by the
moving assemblies.
Note:
1. The operator should use the reagents specified by the company, and store and use
them in strict accordance with the manual.
2. Before using the analyser, you should make sure the reagent is correctly
connected.
3. Position the reagent to stabilise before use it.
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Make sure the pipelines of reagents and waste are not buckled and the connections are right;
Make sure the analyser’s power plug is plugged in the power socket safely.
Check the printer (optional)
Make sure there is plenty of paper for the printer and the installation is correct.
Make sure printer’s the power plug is plugged in the power socket and the printer’s cable has been
connected to the external computer.
Keyboard, mouse, network cable and the external computer
Make sure the external computer’s network cable has connected with the analyser;
Make sure the keyboard and mouse electric cables have been connected with the external computer.
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4. Input correct user name and password in the login dialogue box;
5. Click OK to start the initialization operation;
Note:
1. Make sure theexternal computer’s cable is connected with the analyser before
running the software. If not, the initialization operation will not be executed. It will
be executed until the connection between them has been detected.
2. If the software fails to run repeatedly, please contact our after-sales service
department or the agent.
3. Please confirm if the date/time on the computer of the equipment is consistent
with the actual date/time after the start-up has completed.
4. The initial user name and password of administrator are set by service engineers,
and they are "Admin" by default.
5. The input range of user name and password is 1-12 character(s). Chinese is not
allowed and the password can be blank.
6. During the initialization process, the corresponding start-up prompt information will be displayed in
the information prompt area at the bottom of the interface;
7. The whole start-up initialization process will last for approximately 4-12 minutes (depends on the
condition of last shutdown);
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8. After the initialization has completed, you can enter "Sample Analysis" interface to check the test
result of start-up background.
Note:
1. Background test is the measurement of the analyser for particle interference and
electrical interference.
2. If the first background result during fluidics initialization exceeds the normal
background, then the analyser will execute another background test (not yet achieved).
3. The corresponding sample ID of background test result is "0".
4. High, low or suspicious alerts will not be revealed in background test results.
5. If fault occurs during the initialization process (such asbackground test result exceeds
the normal background), the analyser will have an alarm message. Please refer to
Chapter 11 Failure Solution for the handling methods.
6. Please refer to Appendix A Specifications for the normal background of the
parameters.
7. The privilege of the operator as administrator or user is determined by the login user
name and password, and different functions on the interfaces will be granted according
to the user privilege.
8. If you want to switch users, please click Logout, input user name and password in the
login dialogue box and click OK to login to the software interface as a new user.
9. If test is performed while "abnormal background" failure occurs, unreliable test
results will be obtained.
10. The sequencing of turning on the analyser or running the software is not prescribed.
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6.4 Overview of worklist
Click on the shortcut button area or click Menu, and then select Worklist menu item to enter
the worklist interface.
Parameter explanation
Param
Meanings Operations
eters
Sample ID Test sample ID Enter directly in the input box
Select either "Whole Blood" or
"Predilute" blood mode and "CBC" or
Mode Sample testing mode
"CBC+DIFF" measuring mode from the two
dropdown lists respectively.
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Param
Meanings Operations
eters
Name Patient's name Enter directly in the input box
Input patient's gender in "Gender" box or select
Gender Patient’s gender
from "Gender" dropdown list.
Select the inputting method for age as
"Year", "Month", "Day" or "Hour" from "Age"
Age Patient's age
dropdown list and input the patient's age in the
input box before age unit.
Basic operations
The upper portion of the interface is the worklist while the lower portion is the information input area
including "Sample Information" and "Patient’s Information". The bottom of the interface is the functional
button area.
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Note:
The following operations can be performed in the worklist on the upper portion of the
worklist interface:
(1) Adjust the column width
Click and drag the separation line between columns to adjust the column width.
Note:
The "Sample ID" and "Mode" in the information input area cannot be edited while
the record’s "Analysis Status" is “Analysing”.
(3) Add
1. Click Add and a new record will be added at the bottom of the worklist, and this blank record will be
highlighted in the list;
2. Input sample/patient’s information in the information input area and click Save directly;
3. Click Start Counting and press Sample Absorption on instrument to start counting.
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Note:
Note:
1. Letters, numbers and all characters supported on the keyboard are allowed to be
input in sample ID (including special characters).
2. The sample ID’s allowed length range is [1-20], and it cannot be blank.
3. The ending character of sample ID must be a number, but the sample ID cannot be
all "0".
4. "CBC" measuring mode is for counting only and WBCs will not be classified. The
counting results include 14 parameters and the histograms of WBC, RBC and
PLT;"CBC+DIFF" measuring mode is for counting and the five-differential of
WBCs. The counting results have 24 parameters, differential scattergram, the
histograms of WBC/BASO, RBC and PLT, and 4 research parameters.
5. If the operator has input patient's gender and age, then the system will match the
reference group according to the corresponding relationship automatically.
6. If the matched reference group is not consistent with the reference group
previously selected by the operator (except for the 5 user-defined reference groups),
then the automatically matching reference group will be used.
7. Delivery date/time cannot be earlier than sampling date/time.
8. Sampling and delivery date/time cannot be later than the current system date/time.
9. The age will be calculated automatically according to the difference of "Current
System Date" and "Date of Birth" after entering the date of birth, and the
newly-calculated age value and unit will be displayed in the age value edit box and
unit combo box. The age edit box will be reactivated from greyed out after clearing
the "date of birth".
10. If the date of birth entered is later than the current system date, then the date of
birth will be recognized as invalid.
11. "Sample No + Mode" of the current record cannot be the same as the unblocked
records with "To be Analysed", "Analysing" or "Error" status.
(4) Insert
1. Click a record in the worklist to highlight it;
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2. Click Insert to insert a new record before the highlighted record. The inserted blank row will be
highlighted. Fields in the information input area will display in default values and are activated;
3. Input sample/patient's information in the information input area and click Save directly.
(5) Save
After the operator has edited/added/inserted the record information, click Save directly to save all the
current information.
Note:
"Sample No + Mode" of the current record cannot be the same as the unblocked
records with "To be Analysed", "Analysing" or "Error" status.
(6) Delete
1. Click Delete and the delete dialogue box will pop up;
2. Click Selected Records, All Completed Records or All Records radio button to select the records
need to be deleted."Selected Records" are records with "√" selected in the worklist;
3. Click OK and the prompt dialogue box will pop up;
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4. Click OK to perform deletion operation and refresh the worklist.
Note:
(7) Enquire
1. Click Enquire and the enquire dialogue box will pop up;
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2 Click Find Previous/Find Next to search upward/downward from the currently highlighted record.
The records will be highlighted if they meet the criteria. Click Find Previous/Find Next to continue
enquiring;
3 A round of enquiry will end when it returns to the beginning record. If there is no record that meets
the criteria, "No matching record!" prompt dialogue box will pop up on the interface; Otherwise "Finished
enquiring all records!" prompt dialogue box will pop up on the interface. Click OK to close the prompt
dialogue box;
4 If you want to enquire for other contents, please repeat steps 2-6 to continue enquiring; If you want to
stop enquiring, click Close to close the enquiry dialogue box.
Note:
If the first/last record of the worklist has been reached, it will go back to the last/first
record of the worklist and continue the next cycle of enquiry upward/downward.
(8) Copy
1. Click a record need copied in the worklist to highlight it;
2. Click Copy, a new record is added in the worklist and highlighted;
3. The sample ID will be blank or added 1 to the newly-input sample ID in the worklist. Other
information will be consistent with the copied records.
(9) Block
1. Select the corresponding check box of a sample record in the worklist;
2. Click Block to block and grey out the selected record.
Note:
1. Click Block to block all the selected records includes blocked or unblocked
ones.
(10) Unblock
1. Select the corresponding check box of a blocked sample record in the worklist;
2. Click Unblock to unblock and grey out the selected record.
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Note:
If the selected records are blocked, "Block" button will change to "Unblock" button.
6.5 Daily QC
QC analysis is required to be performed on the analyser every day before performing sample analysis to
ensure reliable analysis results. Please refer to Chapter 8 QC for the specific operation methods of QC
analysis.
Biological risk:
All items (samples, controls, calibrators, reagents, liquid, etc.) and regions that have
contact with these items have the potential biological infection. Operators should
observe laboratory safety operation rules and wear personal protective devices (such
as laboratory protective clothing, gloves, mask, etc.) when touching relevant items or
regions in the laboratory.
Warnings:
Cautions:
Note:
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2. Mix the venous blood and anticoagulant in the tube adequately and rapidly.
Cautions:
For vacuum tube of specification Ф12X75 (excluding the tube cover size), ensure
that the quantity of the whole blood sample is not less than 0.5mL.
Note:
1. Samples that are needed to perform WBC classification or PLT counting should be
kept at room temperature and should be analysed within 8 hours after collection.
2. If analysis results of PLT, MCV and WBC classification are not required, they can
be stored in the refrigerator at 2℃ - 8℃ for 24 hours. Refrigerated samples can
only be used to perform analysis after being at room temperature for at least 30
minutes.
3. Samples that have been laid for a period of time need to be mixed again before
analysis.
2. When the preparation is completed, the following dialogue box will pop up;
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3. Take a clean centrifuge tube. Insert the probe vertically to the bottom of the centrifuge tube after
opening the cover as shown in the following figure to avoid producing bubbles, suspending liquid and
spilling while adding diluent;
4. Press the sample aborption key to add diluent, the interface will pop up the progress prompt box of
adding diluent;
5. When the addition of diluent is completed the buzzer rings and the interface will pop up following
dialogue box. And the user then can move the centrifuge tube away;
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6. Collect 20μL Peripheral blood and rapidly inject it into a centrifuge tube with diluent inside, and then
put the cover on and mix them;
7. After preparation of the prediluted sample, click Cancel to exit the operation of adding diluent;
8. After the exit operation, the prompt dialogue box mentioned above will close automatically;
9. If you need to prepare more diluent, repeat steps 3 - 5.
Note:
1. Operators can also absorb 180μL diluent with a transferpettor.
2. In the preparation progress before adding diluent, the diluent absorbed are just
enough for 20 times, so after preparing 20 shares of diluent, preparation for adding
diluent will be performed again.
3. You should avoid dust while preparing diluent, otherwise analysis errors may
arise.
4. After the peripheral blood fully reacts with the diluent, it needs to be laid for 3
minutes, and then mixed again before analysis.
5. Ensure to perform analysis in 30 minutes after the sample dilutied, otherwise the
analysis result will be unreliable.
6. Samples that have been laid for a period of time need to be mixed again before
analysis.
7. Every laboratory should evaluate the stability of sample analysis results under
predilution blood mode for the number of samples, sample collecting methods and
technical levels.
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6.7 Sample analysis
Note:
Click on the shortcut button area or click Menu, and then select Worklist menu item to enter
the worklist interface.
Newly adding sample record function. Please refer to section " Worklist Overview" in this chapter for
detailed steps.
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6.7.2 Steps of sample analysis
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that have
contact with these items have the potential biological infection. Operators should
observe laboratory safety operation rules and wear personal protective devices (such as
laboratory protective clothing, gloves, mask, etc.) when touching relevant items and
regions in the laboratory.
Warnings:
The probe head is pointed and sharp. Blood samples, controls and calibrators that have
come into contact with the probe have potential biological infection risks. Avoid
touching the probe.
Cautions:
Note:
1. While the probe is absorbing sample, the probe head should keep a certain distance
with the bottom of the container; otherwise it will affect the accuracy of the absorbed
amount.
2. The test tube wall should avoid contacting with the probe head since this will cause
blood to splash downward.
3. You need to select appropriate parameter reference value scopes on the "Setting"
interface before sample analysis; otherwise you may not get the correct alarm prompt
after finishing the sample analysis.
5. If the last completed sample is under the venous whole blood mode, and the next
sample to be analysed is under predilution blood mode, the interface will display the
prompt dialogue box: "The mode of the next sample is predilution blood mode!"
automatically.
6. If the worklist is empty, perform counting directly. The default mode is the same
with the last sample. The default mode is "whole blood - CBC+DIFF" at first.
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6.7.2.1 Whole blood sample analysis
1. Click shortcut button to enter the sample analysis interface. select "vein whole blood" in the
blood mode tab.
2. Shake the whole blood sample as shown in the following figure to fully mix the sample;
3. Put the whole blood sample under the probe to allow the probe to absorb the mixed sample;
4. Press the instrument’s counting button to start the sample analysis procedure;
5. The probe absorbs the sample automatically. The operator can move the sample away when the buzzer
rings. The analyser performs sample analysis automatically. At this time, the status icon and the green light of
state lights flicker, and the content in the "Next Sample" information tab updates automatically;
6. Status icon and state lights recover to green after analysis;
7. Perform analysis for other samples according to this process.
6.7.2.2 Peripheral whole blood sample analysis
1. Take about 20μl of peripheral blood and fully mix it;
2. Click shortcut button to enter the sample analysis interface. select "peripheral whole
blood" in the blood mode tab. The method is the same with "Venous whole blood sample analysis".
6.7.2.3 Predilution sample analysis
1. Click shortcut button to enter the sample analysis interface. select "predilution blood" in the
blood mode tab.
2. Shake the predilution sample with the tube cover firmly fixed on to fully mix the sample;
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3. Open the tube cover of the predilution sample carefully and put the predilution sample under the
probe to allow the probe to absorb the mixed sample;
4. Press the counting button to start the sample analysis procedure;
Note:
The prompt dialogue box before predilution counting will not pop up after setting.
Please refer to section "General Settings" in Chapter 5 Setting for the setting
methods.
5. The probe absorbs the sample automatically. The operator can move the sample away when the buzzer
rings. The analyser performs sample analysis automatically. At this time, the status icon and the green light of
state lights flicker, and the content in the "Next Sample" information tab updates automatically;
6. Status icon and state lights recover to green after analysis;
7. Perform analysis for other samples according to this process.
Note:
1. One is allowed to perform all the operations such as adding, editing or deleting on
other samples which are to be analysed or have errors in the worklist during analysis
procedure.
3. Other related functions of fluidics system fluidics sequence are not allowed to be
performed during the analysis process.
4. If the current interface is not the graph review interface, the latest record’s
information, results and graph will be refreshed and displayed when the operator
switches to the graph review interface.
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3. Analysis results displayed as "***" indicate that the measuring results are invalid or have exceeded
the display range.
Note:
Abnormal WBC
Leucocytosis
Leucopenia
Neutrophilia
Abnormal
Neutropenia
Lymphocytosis
WBC
Lymphopenia
Monocytosis
Eosinophilia
Basophilia
Left shift?
Immature cell?
Questionable
Abn./Atypical Lym?
Erythrocytosis
RBC/HGB Abnormal
RBC distribution abn.
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Anisocytosis
Macrocytosis
Microcytosis
Dimorphologic
Anaemia
Hypochromia
Abnormal Thrombocytosis
PLT
Thrombopenia
The analyser will perform abnormality or questionable alarm for WBC, RBC and PLT according to
scattergrams and histograms. Its influence on parameter results is as shown in the following table.
Abnormal WBC × √ × ×
Left shift? × √ × ×
WBC
Immature cell? × √ × ×
Abn./Atypical Lym? × √ × ×
Leucocytosis √ √ √ √
Leucopenia √ √ √ √
Neutrophilia × √ × ×
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Neutropenia × √ × ×
Lymphocytosis × √ × ×
Lymphopenia × √ × ×
Monocytosis × √ × ×
Eosinophilia × √ × ×
Basophilia × √ × ×
Dimorphologic √ √ × ×
Haemoglobin abn./interfere? √ √ × ×
Anisocytosis √ √ × ×
Microcytosis √ √ √ √
RBC/HGB Macrocytosis √ √ √ √
Erythrocytosis √ √ √ √
Anaemia √ √ √ √
Hypochromia √ √ √ √
PLT clump? √ √ × ×
Thrombocytosis √ √ √ √
PLT
Thrombopenia √ √ √ √
Note:
Microscope is recommended when the PLT counting is less than 100 109 / L.
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6.8 Shutdown
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
have contact with these items have the potential biological infection. Operators
should observe laboratory safety operation rules and wear personal protective
devices (such as laboratory protective clothing, gloves, mask, etc.) when touching
relevant items and regions in the laboratory.
Warnings:
The probe is sharp and may be stained with biologically contaminated materials.
Please be careful when operating the analyser. Do not touch the probe.
Note:
1. To ensure the stability of the analyser and the accuracy of analysis results,
please execute the shutdown operation as required after the analyser has been
running for 24 hours.
2. Operators should perform normal shutdown procedures to shut down according
to the steps below.
Shutdown includes two sections: Shutting down the analyser and exiting the software. The procedures
for "shut down the analyser" and "exiting software system" will be introduced separately below.
Shut down the analyser
1. Click in the shortcut button area and the following figure will pop up:
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2. Click the icon or select Menu Instrument Shutdown Instrument menu item and
the following dialogue box will pop up;
3. Click Yes and the following prompt dialogue box will pop up;
4. Press the counting button to start absorbing immersion solution. The interface will prompt the
progress during the immersion solution absorption process;
5. The progress bar dialogue box will close automatically and the prompt dialogue box will pop up at the
same time;
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6. Press the counting button to start absorbing immersion solution. The interface will prompt the
progress during the immersion solution absorption process;
7. The progress bar dialogue box will close automatically and the prompt progress bar for 5 minutes of
probe cleanser soaking will pop up at the same time;
When the progress bar dialogue box closes automatically, the instrument will automatically perform
cleaning.
8. Probe immersion will be finished after 5 minutes of immersion. The corresponding shutdown prompt
information will be displayed in the information prompt area at the lower portion of the interface during the
shutdown process;
9. The following prompt dialogue box will pop up when the instrument has finished exectuting the
fluidics sequence of fluidics system shutting down;
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10. Switch the "O/I" switch on the left side of the analyser to "O" and this dialogue box will close
automatically;
11. Empty the waste in the waste barrel and handle the waste properly after shutting down.
Warnings:
Operators have an obligation to observe the relevant provisions of the region and
country when discharging and disposing of expired reagent, waste, waste samples,
consumables, etc.
Note:
1. The shutdown operation of the instrument will not be executed if the analyser
and the computer are not connected.
2. Do not shut down the instrument forcibly while counting or other fluidics system
fluidics sequence is running.
3. If failure affecting shutdown occurs during the shutdown process, the analyser
will return to the status before shutdown and prompt an alarm. Please refer to
Chapter 11 Troubleshooting for the troubleshooting methods.
4. If Restart is clicked, the analyser will start again and perform initialization.
5. The software will not exit after the analyser has shut down. Users can still
perform operations that are not related to the analyser.
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2. Click the icon to perform shutdown process. The entire software system will exit
automatically when the process has been completed.
Note:
You can only exit the software of the computer end after shutting down the
instrument of the analyser end.
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Results review
7.1 Overview
The analyser will store sample information, result data, Flag prompt information, histograms and
scattergrams in the review database automatically after each sample analysis. The sample library of the
analyser can store up to 100,000 sample records.
Operators can review sample information, result data, Flag prompt information, histograms and scattergrams
saved in the review database in the form of graph or list in graph review interface or list review interface.
Click in the shortcut button area (click the icon button to switch between graph review and list
review interfaces) or click Menu and select Review Graph Review in the pop-up menu to enter the graph
review interface as shown in the figure below.
The graph review interface is composed of 4 sections. Sample/patient's information is displayed in the upper
portion of the interface while result data, scattergram, histogram, alarmFlag, DIFF diagram, microscopy
result and blood type/RSR rate result of the sample corresponding to the sample/patient’s information are
displayed in the lower portion of the interface in the format of "Graph/Data", "DIFF", "Others" and
"Research" tabs. The functional buttons available in the interface are displayed at the bottom of the interface.
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7.2.1Sample/patient's information
Operators can browse sample records one by one by using the record switching bar on the lower right of the
interface.
Sample/patient’s information of records can be checked in the upper portion of the interface. Operators can
directly edit patient’s information except for sampling mode, blood mode, analysis mode, verification,
operator and proving time. Please refer to the relevant contents of "Enter Worklist Information" section in
Chapter 6 Daily Operations for the operations of the related information editing.
Note:
1. Normal users can edit sample IDs, in "Settings". Please refer to Chapter 5 Settings
for specific details.
2. Operators are allowed to edit sample information except for sampling mode blood
mode, analysis mode, verification, operator and proving time.
7.2.2 Tab
The corresponding information can be checked in the tab at the bottom of the interface after selecting a
sample record.
7.2.2.1 Data/Graph
Click Data/Graph tab in the interface to check data/graph information of the record.
A magnifying glass icon will appear when the mouse cursor moves over any graph in the histograms.
Operators can click this graph with a pop-up dialogue box where the operators can drag the Enlarged
Drawing dialogue box freely.
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Operators can click "╳" on the upper right of the dialogue box to close it after browsing.
Note:
You can select whether to display 4 research parameters, "*" marks and related
declarations ("*" indicates research parameters, cannot be used as basis for clinical)
in "Settings". Please refer to Chapter 5 Settings for specific details.
Basic operations
(1) Save
Click Save to save all modified information in all tabs of the current sample.
(2) Print
Click Print to print the information, result data, histograms and scattergram of the current
sample.
(3) Delete
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1. Click Delete and the delete confirmation dialogue box will pop up;
2. Click OK to delete the sample record displayed in the current graph review interface.
Note:
Delete is not visible to users and the deletion operation cannot be performed.
(4) Verification
Note:
1. Users can be authorized with verify privilege in "Settings"; otherwise, the users
will need to perform privilege authentication by entering administrator's user name
and password.
(5) Cancel
Note:
1. If the current sample has been verified, then Review will change to Cancel.
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(6) Edit results
1. Click Edit and the edit boxes of the results of measurement parameters will be activated. Operators can
modify the results directly in the edit boxes;
2. After the results have been modified, click Save to save them. The edit boxes of the results will then
disappear automatically.
Note:
1. Uses can be authorized with the privilege to edit results in "Settings"; otherwise, the
users will need to perform privilege authentication by entering administrator’s user name
and password.
2. If the result data of a measurement parameter has been modified, then the result value
of the corresponding parameter will also be changed and high/low questionable alarm
will be applied according to the modified results.
3. Only the results of measurement parameters (WBC, RBC, HGB, MCV and PLT) can
be modified.
4. If the results have been edited, then the manually modified parameter’s results will be
marked with "E" after them no matter whether the sample has been verified or not. As
some parameter’s results have been manually modified, the modified result data of the
corresponding parameter’s results will be marked with "e" ("E" or "e" marks will be
displayed between the result data and the parameter’s units).
Note:
1. If the "Edit Results" privilege is open to users in "Settings", then the "Recover"
privilege is also open to users by default. Otherwise, the users will need to perform
privilege authentication by entering administrator’s user name and password.
2. The instrument can only save the latest 100,000 original measurement results of the
modified samples.
7.2.2.2 DIFF
Click DIFF tab in the interface to check WBC classification information of each record.
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A magnifying glass icon will appear when the mouse cursor moves over any graph in the histogram.
Operators can click this graph with a pop-up dialogue box where the operators can drag the Enlarged
Drawing dialogue box freely.
Operators can click "╳" on the upper right of the dialogue box to close it after browsing.
Note:
1. DIFF tab will be greyed out and cannot be browsed if the analysis mode is CBC.
2. You can select whether to display the 4 research parameters, "*" marks and related
declarations ("*" indicates research parameters, cannot be used as basis for clinical) in
"Settings". Please refer to Chapter 5 Settings for specific details.
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Basic operations
Refer to the basic operations in the "Data/Graph" section in the chapter for specific details about editing or
recovering result data.
Parameter explanation
Click the edit box of "Microscopy Time" and enter date and time
Micro.Time Microscopy time
of microscopy.
Describe cellular Directly enter the morphological information of each cell in the
Microscopy
morphologies of
description box
WBC, RBC and PLT.
Cell The percentages of each classified cell in the edit boxes can be
Cell Classification
Classification entered after the names of the 22 categorized cells respectively.
Select the patient's blood type in "Blood type/ESR" bar. Select
"Blank", "A", "B", "O" or “AB" in the first combo box after
Blood type Patient's blood type
clicking blood type, and select "Blank", "RH+" or "RH-" by
clicking the second combo box.
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Parameters Meanings Operations
1. Click Set ref. scope, and the following dialogue box will pop
up. Enter the lower limit and the upper limit of the reference
value of RSR rate in the "Lower limit" and "Upper limit" edit
boxes:
Note:
2. The value range of cell classification entered is [0.0-100.0] and the unit is "%".
3. RSR rate information: The upper and lower limit range can be entered is [0, 999] and
only one to three digit number can be entered. The upper limit cannot be less than the
lower limit; The reference range of ESR results for each sample is only effective to that
result, and the default reference range is [0, 20].
Basic operations
Refer to the basic operations in the "Data/Graph" section in the chapter for specific details about editing or
recovering result data.
Note:
2. In the Settings, you can select whether to print Flag prompt information when printing
reports.
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7.2.2.4 Research
Click Research tab in the interface and then you can check the specific value of each parameter result.
Note:
1. Specific value for parameter results that have exceeded the display range or with no
collected data cannot be given.
2. Editing the result of "Data/Graph" tab does not affect displaying each parameter of
"Research" tab.
3. The content of this tab is for research and checking only and cannot be edited or
printed.
Click in the shortcut button area (you can switch between the graph review and list review
interfaces by clicking the icon button) or click the "Menu" button, and select "Review" "List review" in the
menu that pops up to enter the list review interface shown in the figure below.
The list review interface is composed of 3 parts. The upper area of the interface contains sample records
presented as a list while the lower area thereof contains sample results data, complete sample information and
patient information, microscopy results and blood type/RSR rate results corresponding to the current sample
record. Function buttons available in the interface are displayed on its uppermost side and lowermost side.
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7.3.1 Sample record
You can browse each sample record and its main sample/patient’s information in the list review interface.
Note:
1. For sample result with errors, the content of each information field will be
displayed in red.
2. For a printed sample, the relevant cell of the "Print" column will be displayed as
"P"; For an unprinted sample, the relevant cell of the "Print" column will be displayed
as blank.
3. For a verified sample, the relevant cell of the "Verification" column will be
displayed as "V"; For an unverified sample, the relevant cell of the "Verification"
column will be displayed as blank.
You can execute the following operations in the sample record list area:
(1) Select sample list
Click Sample list combo box and select "Samples within today", "All Samples" or "Query result". The
default option for "Sample list" is "Samples within today".
The records displayed in the review list will be different if you select different options, and the relationship
between the two is shown as follows:
Record option Record displayed in the list
All samples Display all sample records stored in the sample library
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Query result Display all sample records that meet the query conditions
7.3.2 Tab
The corresponding information can be checked in the tab at the bottom of the interface after selecting a
sample record.
Note:
You can select whether to display 4 research parameters, "*" marks and related
declarations ("*" indicates research parameters, cannot be used as basis for clinical)
in "Settings". Please refer to Chapter 5 Settings for specific details.
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Basic operations
(1) Save
Click Save to save all modified information in all tabs of the current sample.
(2) Print
Click Print to print the information, result data, histogram and scattergram of the current sample.
(3) Delete
Note:
(4) Query
Operators can search specified sample records in the current operation list. The searched
record scope is always within all sample records.
1. Click Query, and the enquire combo box shown below will pop up.
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2. Operators can confirm the query conditions according to requirements.
Parameter explanation
Click the check box in front of "Sample ID" which will then
Sample ID Query Sample ID turn into "√" state and enter the sample ID in the "Sample
ID" box.
Click the check box in front of "Name" which will then turn
Name Query patient’s name
into "√" state and enter the patient's name in the "Name" box.
Click the check box in front of "Gender" which will then turn
Query patient's
Gender into "√" state and click Male, Female or Blank radio button
gender
to select the patient's gender.
Patient ID Query patient's ID Click the check box in front of "Patient ID" which will then
turn into "√" state and enter the patient's ID in the "Patient ID
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Parameters Meanings Operations
" box.
Click the check box in front of " Bed No." which will then
Query patient's bed
Bed No. turn into "√" state and
number
enter the patient's bed number in the " Bed No." box.
Query deliver's Click the check box in front of "Deliverer" which will then
Deliverer turn into "√" state and enter the name of the person who
number
submitted the inspection request in the "Deliverer " box.
Query sample Click the check box in front of "Verification" which will then
Verification turn into "√" state and click Verified or Not verified radio
verification state
button to select the verification state.
Query sample Click the check box in front of "Printing state" which will
Printing state then turn into "√" state and click Printed or Not Printed
printing state
radio button to select printing state.
3. Click OK to execute query operation according to the query conditions and then automatically switch to
"Query Result" list in "List Review" to display all query records.
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Note:
(5) Verification
Note:
1. Users can be authorized with verify privilege in "Settings"; otherwise, the users
will need to perform privilege authentication by entering administrator's user name
and password.
Click Batch Verification and a dialogue box as shown below will pop up;
1. Click Checked Records or Specify Record to select records that require batch verification. "Checked
Records" are records selected with "√" in the review list;
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2. If "Specify record" radio button is clicked, then the specified start and end proving date that require batch
verification will be performed;
3. Click OK to execute batch verification operation.
Note:
4. You can choose whether to automatically remove the "√" marks in front of the
verified records.
(7) Cancel
Note:
1. If the current highlighted record has been verified, then Verification button will
change to Cancel.
4. You can choose whether to automatically remove the "√" marks in front of the
verified records.
1. Click Edit and the inspection data edit box corresponding to each test parameter in "Result" tab will be
activated. Operators can directly modify the results in the edit box;
2. After the results have been modified, click Save to save them.
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Note:
1. Users can be authorized with the privilege to edit results in "Settings"; otherwise,
the users will need to perform privilege authentication by entering administrator’s user
name and password.
2. If the result data of a measurement parameter has been modified, then the result
value of the corresponding parameter will also be changed and high/low questionable
alarm will be applied according to the modified results.
3. Only the results of measurement parameters (WBC, RBC, HGB, MCV and PLT)
can be modified.
4. If the results have been edited, then the manually modified parameter’s results will
be marked with "E" after them no matter whether the sample has been verified or not.
As some parameter’s results have been manually modified, the modified result data of
the corresponding parameter’ results will be marked with "e" ("E" or "e" marks will be
displayed between the result data and the parameter’s units).
2. Click OK to recover the results of each parameter to the original measured values of the analyser and
remove the marks ("E" or "e") resulted from the execution of "Edit".
Note:
1. If the "Edit" privilege is open to users in "Settings", then the "Recover" privilege is
also open to users by default. Otherwise, the users will need to perform privilege
authentication by entering administrator’s user name and password.
2. The instrument can only save the latest 100,000 original measurement results of the
modified samples.
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(10) Tendency chart
Operators can check the tendency chart of the selected sample results.
1. Operators can select the sample results with "√";
2. Click Tendency Chart. The system will automatically calculate Mean, SD, CV% and deviation limit, and
the calculated result dialogue box will pop up as shown below;
Note:
1. Operators can check the tendency chart only after selecting at least 3 sample
records.
2. The maximum number of selected records is the number of all records in the
review list.
3. There is no restriction for the sample records selected in the tendency chart as
long as they are the records in the review list.
(11) CV
Operators can check the reproducibility values of each parameter of the selected sample results.
1. Operators can select the sample records used in the reproducibility calculation with "√";
2. Click CV. The system will automatically perform repeatability calculation and the calculated result
dialogue box will pop up as shown below;
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3. Click Calc Deviation and a dialogue box will pop up as shown below. Operators can check the absolute
deviation values of the percentages of the 5 WBC classification parameters;
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4. Click Close to exit after browsing.
Note:
1. Operators can perform repeatability calculation only after selecting at least 3 sample
records.
2. The maximum number of selected records is the number of all records in the review
list.
3. There is no restriction for the sample records selected for the repeatability calculations
as long as they are the records in the review list.
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2. Click Checked Records or Specify Records radio button to select the records to be exported."Checked
Records " are records selected with "√" in the review list;
3. If Specify Records radio button is clicked, then the specified start and end proving data that are required to
be exported will be performed;
4. Click OK and a dialogue box will pop up as shown below;
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5. Select data export path, export file type and enter the export file name;
6. Click OK and a progress bar dialogue box will pop up;
Note:
1. The export file type is in .csv format by default and .txt format can also be selected.
2. The sequence of exported sample data records and each sample is consistent with the
ascending or descending order of the inspection time displayed in the list review
interface.
3. Exported data file does not support historical review for checking. Operators can edit
or delete the exported data file externally.
4. 3 histograms and 1 scattergram are exported as bmp format to "Bmp" folder under the
selected data export path.
5. You can choose whether to automatically remove the "√" marks in front of the
exported records.
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1. Click Checked Records or Specify Records to select the records that are required to be backed up."
Checked Records" are records selected with "√" in the review list;
2. If Checked Records radio button is clicked, then the specified start and end proving data that are required
to be exported will be performed;
Note:
2. It is not allowed to modify the backup sample data. It can only be checked as
historical review.
3. 3 histograms and 1 scattergram are backed up as bmp format to "Bmp" folder under
the selected data backup path.
4. You can choose whether to automatically remove the "√" marks in front of the
backed up records.
5. You can choose whether to automatically delete the records that have been backed
up.
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2. Select the file name of backup data you want to browse after selecting the directory of the backup data;
3. Click OK to display the selected backup data;
4. The data displayed in graph review and list review interfaces can only be browsed and checked.
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Please refer to the relevant contents of "Enter Work list Information" section in Chapter 6 Daily Operations
for the operations of the related information editing.
Parameter explanation
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Parameters Meanings Operations
Click the edit box of "Micro.Time" and enter date and time of
Micro.Time Microscopy time
microscopy
Describe cellular Directly enter the morphological information of each cell in the
Microscopy
morphologies of
description box
WBC, RBC and PLT.
Cell The percentages of each classified cell in the edit boxes can be
Cell classification
classification entered after the names of the 22 categorized cells respectively.
Select the patient's blood type in "B.Type" bar. Select "Blank",
"A", "B", "O" or “AB" in the first combo box after clicking
B.Type Patient's blood type
blood type, and select "Blank", "RH+" or "RH-" by clicking the
second combo box.
1. Click Set ref. Scope, and the following dialogue box will pop
up. Enter the lower limit and the upper limit of the reference
value of RSR rate in "Lower limit" and "Upper limit" edit
boxes;
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Note:
2. The value range of cell classification entered is [0.0-100.0] and the unit is "%".
3. RSR rate information: The upper and lower limit range can be entered is [0, 999] and
only one to three digit number can be entered. The upper limit cannot be less than the
lower limit; The reference range of ESR results for each sample is only effective to that
result, and the default reference range is [0, 20].
7.3.2.4 Research
Click Research tab in the interface and then you can check the specific value of each parameter result.
Note:
1. Specific value for parameter results that have exceeded the display range or with no
collected data cannot be given.
2. Editing the results in "Data/Graph" tab will not affect the display of each parameter in
"Research" tab.
3. The contents in this tab are for research and checking only and cannot be edited,
printed or communicated.
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QC
Chapter 8. QC
8.1 Overview
A certain degree of error may occur when the haematology analyser has been used for a long period of time.
Errors may cause failure or unreliable analysis results. QC procedures provide an effective method for testing
errors that may exist. Operators can effectively eliminate the effects of errors to the analysis results only
when they are familiar with the theory of QC and have mastered the actual operation methods.
To ensure the reliability of the sample analysis results, operators are recommended to use controls of low,
normal and high levels respectively to perform QC on the analyser every day. When the controls with new lot
number are required, please use them with the current controls in parallel twice daily for 5 days. The results
obtained should be within the reference range specified in its operating manual.
The analyser provides four methods of QC: L-J QC, X QC, X -R QC and X-B floating average mean
method QC.
Note:
Operators should use the controls and reagents designated by our company, and store
and use them in strict accordance with the operation manual. Controls (similar with
standard blood samples) must be used before the expiry date and thoroughly mixed
before use.
8.2 L-J QC
8.2.1 QC edit
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
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Note:
1. Only the users at an administrator level have the privilege to perform QC edit.
2. For the QC files containing QC results, the modified data will be highlighted with
yellow background and recorded in the system log if the parameter reference values
or deviation limits have been modified and saved that will lead to the changes in
reference values and deviation limits.
A QC file for each lot number of controls needs to be set before analysing a new batch of controls and the QC
information in the file can be edited through any one of the following methods.
Manual entry.
Read saved preset value.
8.2.1.1 Manual entry
(1) Enter the QC chart interface by any one of the following methods:
1. Click QC on the shortcut button area.
2. Click Menu on the interface, and select QC L-J QC in the pop-up menu.
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(2) Click Settings tab to enter the L-J QC setting interface.
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
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Note:
(4) Input the lot number of the controls by any one of the following methods.
1. Input manually
2. Input by using an external barcode scanner (not supported temporarily)
Note:
1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.
2. The lot number and QC mode of the QC file cannot be the same simultaneously.
Note:
The input range of expiry date is [the current system date, 2099-12-31]. It cannot be
null.
Note:
The lot number and QC mode of the QC file cannot be the same simultaneously.
Note:
If the preset value of the current level is stored in the system (reference values and
deviation limits), it can be read to the current QC file. Please refer to 8.2.3 QC
Results Review for the calculating and saving methods of preset values.
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(1) Basic operations
1. Enter the QC chart interface by any one of the following methods:
a. Click QC in the shortcut button area;
b. Click Menu on the interface and select QC L-J QC in the pop-up menu;
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2. Click Settings to enter the L-J QC setting interface.
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
Note:
4. Input the lot number of the controls by any one of the following methods.
a. Input manually;
b. Input by using an external barcode scanner (not supported temporarily).
Note:
1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.
2. The lot number and QC mode of the QC file cannot be the same
simultaneously.
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Note:
The input range of expiry date is [the current system date, 2099-12-31]. It cannot
be null.
Note:
The lot number and QC mode of the QC file cannot be the same simultaneously.
Note:
If preset values of some parameters to undergo QC are not provided, you will
need to input their reference values and deviation limits manually; If you don't
want to perform QC on some parameters that are provided with preset values, you
can delete their reference values and deviation limits manually after obtaining the
preset values.
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(2) Click Calculate by Absolute Value to display the deviation limit in the form of an absolute value; Click
Calculate by Percentage to display the deviation limit in the form of a percentage;
(3) If you choose to calculate by absolute value, click 2SD or 3SD, then the deviation limit will be calculated
according to 2 or 3 times of the SD; If you choose to calculate by percentage, click 2CV or 3CV, then the
deviation limit will be calculated according to 2 or 3 times of the CV;
(4) Click OK to save settings of deviation limits.
8.2.1.4 Print
Click Print to print the setting information of the current QC file.
8.2.2 QC analysis
You can select one of the following methods to perform QC analysis according to the QC mode selected after
editing the QC:
Whole blood
Predilution
8.2.2.1 QC analysis (whole blood)
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
8-8
when touching relevant items and regions in the laboratory.
Warnings:
1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.
5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.
6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.
Note:
Note:
1. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
2. If the blood mode switches from "predilution" to "whole blood", the analyser
will execute mode switching fluidics sequence automatically and display the
progress bar prompt on the interface.
(1) Enter the QC chart interface by any one of the following methods:
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3. Enter the L-J QC chart interface.
8-10
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions.
(7) Perform QC analysis:
1. Confirm that the QC mode is "whole blood" and the counting status icon and state light of the analyser are
green;
2. Shake the prepared controls as shown in the following figure to thoroughly mix it;
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3. Click Start QC Counting;
4. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
5. Press the counting button to initiate the QC analysis;
6. The buzzer rings when the absorption is completed. The user can remove the controls.
(8) After the analysis, the QC results obtained will be displayed on the current interface and will be
automatically saved in the current QC files;
Note:
(9) You may continue to perform QC analysis according to the steps above if necessary.
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QC
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.
Warnings:
1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to keep them from injury.
5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.
6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.
Note:
Note:
The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
8-13
(1) Enter the QC chart interface by any one of the following methods:
8-14
(2) Click Counting tab to enter the L-J QC counting interface;
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "predilution" and the counting status icon and state light of the analyser are
green;
2. Click Add Diluent in the shortcut button area and the following prompt box will pop up;
3. When the preparation is completed, the following dialogue box will pop up;
8-15
4. Take a clean centrifuge tube. Insert the probe vertically into the bottom of the centrifuge tube after opening
the cover as shown in the following figure to avoid producing bubbles, suspending liquid or spilling while
adding diluent;
6. The buzzer rings when the addition of diluent is completed. The user then can remove the centrifuge tube;
7. Collect 20μL of the controls and inject it into a centrifuge tube with diluent inside. Then fix the cover on
and thoroughly mix it;
8-16
8. Click Cancel to exit the diluent addition dialogue box;
11. Put the centrifuge tube under the probe after opening the cover to allow the needle to suck up the fully
mixed controls;
12. Press the counting button to initiate the QC analysis;
13. The buzzer rings after the absorption process is completed. The user can remove the centrifuge tube.
(8) After the analysis, the QC results obtained will be displayed on the current interface and will be
automatically saved in the current QC files;
Note:
2. Prevent dust from entering the prepared diluent, otherwise analysis errors may
8-17
arise.
3. After controls are fully reacted with the diluent, it needs to be laid for 3 minutes,
and then mixed again before analysis.
4. Make sure to perform the analysis within 30 minutes after the sample is diluted,
otherwise the analysis results will be unreliable.
5. Samples that have been laid for a period of time need to be mixed again before
analysis.
(9) You may continue to perform QC analysis according to the steps above if necessary.
Click or to switch the current QC result to the previous one or the next one of the current
result. Click or to switch the current QC result to the earliest saved result or the newest
Note:
1. Expired QC analysis results will be marked with the letter "O" before it.
2. The results out of the set deviation limit range are marked with "↑" or "↓" for
prompting;
3. For the QC files that store QC results, if the upper and lower limit ranges of
some parameters are changed when the reference values or deviation limits of these
parameters are modified and saved, the changed data will be highlighted in yellow.
8-18
8.2.3.1 QC chart review
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
(1) Enter the QC chart interface by any one of the following methods:
1. Click QC in the shortcut button area;
2. Click Menu in the interface and select QC L-J QC in the pop-up menu;
8-19
(2) Select the file number of the QC file you want to review, and the interface will display corresponding file
information and QC chart;
(3) Drag the scroll bar on the right of the QC chart up and down to review the param QC chart that you want
to review. Drag the scroll bar below the QC chart left and right to review all the QC results.
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1 - Average values (Mean), standard deviations (SD) and coefficients of variation (CV%) of all the QC results
of all the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The operator that performs QC analysis and obtains the QC point at which the green vertical line lies;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - When clicking a QC point in the QC chart, mark this point and the QC points of the parameters that are
saved at the same time with green vertical lines;
8 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.
Note:
1. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.
2. For the QC files that store QC results, if the upper and lower limit ranges of
some parameters are changed when the reference values or deviation limits of
these parameters are modified and saved, the changed data will be highlighted in
yellow.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
Click or to move the green vertical line to the previous or next QC point; Click or
to move the green vertical line to the first or the last QC point of the QC chart. When the location of
the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.
If the reviewed QC result is obtained from analysing the controls that are newly opened within the same
batch, the QC points of new bottles should be marked based on the following steps to differentiate the QC
analysis results of the controls in old bottles and new bottles:
(1) Move the green vertical line to the QC point of the first new bottle;
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(2) Click New Bottle, and there will be a blue vertical line at the QC point of the new bottle;
(3) Open the controls within the same new bottle batch again and save its QC analysis results. Then click
Cancel New Bottle and cancel the original mark. And then mark the QC point of the new bottle according to
Step 1 and Step 2.
If you want to compare the QC charts of the same parameter in different batches of controls, please follow
the steps below:
(1) Click Data Comparison, and the selection of QC chart is provided;
(2) Select the files numbers of QC files that you want to compare in the File Number box in turn (3 file
numbers at most). The corresponding QC chart of the selected file number is displayed below the file number,
and its batch, QC mode and level are also displayed;
(3) You can select the QC charts of different parameters in the Parameter box to compare as required.
Note:
The display form and view method of the QC chart are in accordance with the QC
chart interface. The lines connecting QC points are grey, black and orange so as to
differentiate the QC charts of different levels of controls.
(4) If you want to print the currently compared parameter QC chart, please click Print (not supported
temporarily);
(5) Click Close to exit.
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8.2.3.1.5 Display sequence
If you want to change the display sequence of different parameter QC charts, please follow the steps below:
(1) Click Display Sequence, and the display sequence of the current QC charts will be provided;
(2) Click the parameter that is desired to adjust the display order of the QC chart;
If the already existing QC parameter has three or more QC results within the upper and lower limit range,
then the preset values of QC parameters can be calculated and saved by following these steps.
(1) Click Calculate Preset Value to display two selection lines within the preset value calculation range.
(2) Click and drag each selection line separately to position at the start point and end point of the preset value
calculation range.
(3) The values of Mean, SD, and CV% on the right of the QC chart are refreshed as the calculation results of
the selected range.
(4) If you want to save the calculation result, please click Save Preset Value to save the existing calculation
results of Mean, SD and CV% as the preset values of the corresponding levels (high/normal/low). Then, the
8-23
selection lines will disappear and Mean, SD, and CV% on the right of the QC chart will restore to the
calculation values of all the QC results.
Note:
1. The preset values will be calculated and displayed for the parameters that have 3
or more results within their calculation ranges and upper and lower limit ranges;
Otherwise, the preset values are empty.
2. Three saving functions are provided according to the levels (high, normal, and
low) of controls.
3. The results of all the parameters must be within its upper and lower limit range
when calculating the preset values.
If you want to enter why the QC point is out of control, please follow the steps below:
(1) Click Out of Control after moving the green vertical line to the QC point desired to enter the reason for
loss of control. It will display the QC results, reference values and deviation limits of all parameters where
the green vertical lines lie (QC results that exceed the range of upper and lower limits will be marked in red)
and provide the function of entering the reason for loss of control;
(2) The reason for loss of control can be selected from a list of provided reasons. Or one can manually enter
the reason for Loss of Control (200 characters max.) in the edit box after clicking the Others option;
(3) Click OK to save the entered reason for loss of control and exit.
8-24
Note:
After entering the reason for loss of control for a set of QC points of which the
QC results of parameters are within the deviation limits, the whole set of QC data
will be all marked in red that correspond to this set of QC points in QC chart/QC
list. If the reason for loss of control is cancelled and saved, the corresponding
whole set of QC data will be recovered and shown as black again.
8.2.3.1.8 Delete
With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
(4) Click OK and confirm. All the selected data will be deleted.
Note:
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.
8-25
(1) Enter the QC list interface by any one of the following methods:
8-26
(2) Click the QC List tab and enter the L-J QC list interface;
(3) Select the file number of the QC files you want to review, and the interface will display corresponding file
information and QC list;
(4) Drag the scroll bar on the right of the QC list up and down to review the parameter QC result you want to
review. Drag the scroll bar below the QC list left and right to review all the QC results.
1 - Serial number of QC results saved in QC files (arranged from left to right and from old to new);
8-27
2 - QC results;
3 - QC parameter (the display order is in accordance with the QC chart interface);
4 - QC warning signs: The results out of the set deviation limit range are marked with "↑" or "↓" for
prompting;
5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.
Note:
For the QC files that store QC results, if the reference values or deviation limits of
some parameters are changed when the reference values or deviation limits of these
parameters are modified and saved, the changed data will be highlighted in yellow.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
Click or , and the previous or the next QC result will be highlighted; Click or ,
and the first or the last QC result will be highlighted in the QC list.
8.2.3.2.3 Delete
With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
(4) Click OK and confirm. All the selected data will be deleted.
8-28
Note:
If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data export to provide the function of entering the file names of the exported path and related data;
(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [L-J_QC_Data saved date_time]);
(6) The interface prompts that the exporting is finished. Click OK to exit.
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Note:
You can modify the exported data if necessary, but you cannot check it through
Historical Review function.
If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;
8-30
(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the backup data (default to: [L-J_QC_Data saved date_time]);
(5) The interface prompts that the backup is completed. Click OK to exit.
Note:
1. The backup data cannot be modified. You can check it through Historical Review
function.
2. You can click Cancel on the progress bar to cancel the backup during the backup.
If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;
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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;
(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;
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(5) Click Close to exit after reviewing.
8.3 X Mean QC
8.3.1 QC edit
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
Note:
1. Only the users at an administrator level have the privilege to perform QC edit.
2. For the QC files containing QC results, the modified data will be highlighted
with yellow background and recorded in the system log if the parameter reference
values or deviation limits have been modified and saved that will lead to the
changes in reference values and deviation limits.
A QC file for each lot number of controls needs to be set before analysing a new batch of controls and the QC
information in the file can be edited through any one of the following methods.
Manual entry.
Read saved preset value.
8.3.1.1 Manual entry
(1) Enter the QC chart interface by the following methods:
1. Click Menu on the interface, and select QC X Mean QC in the pop-up menu;
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2. Enter X Mean QC chart interface.
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
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(3) Select a QC file number of which the QC information is empty;
Note:
(4) Input the lot number of the controls in one of the following ways;
1. Input manually
2. Input by using an external barcode scanner (not supported temporarily)
Note:
1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.
2. The lot number and QC mode of the QC file cannot be the same
simultaneously.
Note:
The input range of expiry date is [the current system date, 2099-12-31]. It cannot
be null.
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(6) Select the QC mode for analysing the controls;
Note:
The lot number and QC mode of the QC file cannot be the same simultaneously.
(2) Click Calculate by Absolute Value to display the deviation limit in the form of an absolute value; Click
Calculate by Percentage to display the deviation limit in the form of a percentage;
(3) If you choose to calculate by absolute value, click 2SD or 3SD, then the deviation limit will be calculated
according to 2 or 3 times of the SD; If you choose to calculate by percentage, click 2CV or 3CV, then the
deviation limit will be calculated according to 2 or 3 times of the CV;
(4) Click OK to save settings of deviation limits.
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8.3.2 QC analysis
You can select one of the following methods to perform QC analysis according to the QC mode selected after
editing the QC:
Whole blood
Predilution
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.
Warnings:
1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.
5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.
6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.
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Cautions:
Note:
1. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
2. If the blood mode switches from "predilution" to "whole blood", the analyser
will execute mode switching fluidics sequence automatically and display the
progress bar prompt on the interface.
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(2) Click Counting tab to enter X Mean QC counting interface.
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
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1. Confirm that the QC mode is "whole blood" and the counting status icon and state light of the analyser are
green;
2. Shake the prepared controls as shown in the following figure to fully mix it;
4. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
5. Press the counting button to initiate the QC analysis;
6. The buzzer rings when the absorption process is completed. The user can then remove the controls;
7. When the analysis is finished, the interface will display the QC results of the first analysis;
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8. When the controls are mixed again, please perform the second QC analysis according to the prompts on the
interface;
Note:
You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.
9. The buzzer rings when the absorption process is completed. The user can then remove the controls.
(8) When the analysis is completed, the QC results obtained (two times of the QC counting values and
average values X ) will be displayed on the current interface and will be automatically saved in the current
QC files;
Note:
1. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.
(9) You may continue to perform QC analysis according to the steps above if necessary.
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
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protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
Warnings:
1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase the
risks of biological problems. Please be careful when operating the uncovered blood
collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood collection
tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.
5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical mask,
etc.) when touching reagent-related items in the library.
6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty of
water and seek medical treatment from a doctor.
Note:
Note:
The operator must use disposable items specified by the company, such as vacuum
blood collection tubes, centrifuge tubes, capillaries, etc.
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2. Enter X Mean QC Chart interface.
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
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(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "predilution" and the counting status icon and state light of the analyser are
green;
2. Click Add Diluent in the shortcut button area and the following prompt box will pop up;
3. When the preparation is completed, the following dialogue box will pop up;
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4. Take a clean centrifuge tube. Insert the probe vertically into the bottom of the centrifuge tube after opening
the cover as shown in the following figure to avoid producing bubbles, suspending liquid or spilling while
adding diluent;
6. The buzzer rings when the addition of diluent is completed. The user then can remove the centrifuge tube;
7. Collect 20μL of the controls and inject it into a centrifuge tube with diluent inside. Then fix the cover on
and thoroughly mix it;
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8. Click Cancel to exit the diluent addition dialogue box;
11. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
12. Press the counting button to initiate the QC analysis;
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13. The buzzer rings when the absorption is completed. The user can then remove the controls;
14. When the analysis is finished, the interface will display the QC results of the first analysis;
15. When the controls are mixed again, please perform the second QC analysis according to the prompts on
the interface;
Note:
You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.
16. The buzzer rings when the absorption process is completed. The user can then remove the centrifuge tube.
(8) When the analysis is completed, the QC results obtained (two times of the QC counting values and
average values X ) will be displayed on the current interface and will be automatically saved in the current
QC files;
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Note:
2. Prevent dust from entering the prepared diluent, otherwise analysis errors may
arise.
3. After controls are fully reacted with the diluent, it needs to be laid for 3
minutes, and then mixed again before analysis.
4. Make sure to perform the analysis within 30 minutes after the sample is
diluted, otherwise the analysis results will be unreliable.
5. Samples that have been laid for a period of time need to be mixed again before
analysis.
8. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.
(9) You may continue to perform QC analysis according to the steps above if necessary.
Click or to switch the current QC result to the previous one or the next one of the current
result. Click or to switch the current QC result to the earliest saved result or the newest saved
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Note:
1. Expired QC analysis results will be marked with the letter "O" before it.
3. For the QC files that store QC results, if the upper and lower limit ranges of
some parameters are changed when the reference values or deviation limits of
these parameters are modified and saved, the changed data will be highlighted in
yellow.
8.3.2.4 Print
Click Print and print the result on the current QC counting interface.
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
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2. Enter X Mean QC Chart interface.
(2) Select the file number of the QC file you want to review, and the interface will display corresponding file
information and QC chart;
(3) Drag the scroll bar on the right of the QC chart up and down to review the parameter QC chart that you
want to review. Drag the scroll bar below the QC chart left and right to review all the QC results.
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8.3.3.1.1 Introduction to QC Chart interface
1 - Average values (Mean), standard deviations (SD) and coefficients of variation (CV%) of all the QC results
of all the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The operator that performs QC analysis and obtains the QC point at which the green vertical line lies;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - When clicking a QC point in the QC chart, mark this point and the QC points of the parameters that are
saved at the same time with green vertical lines;
8 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.
Note:
2. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.
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3. For the QC files that store QC results, if the reference values and upper and
lower limit ranges of some parameters are changed when the reference values or
deviation limits of these parameters are modified and saved, the changed data will
be highlighted in yellow.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
Click or to move the green vertical line to the previous or next QC point; Click or
to move the green vertical line to the first or the last QC point of the QC chart. When the location of
the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.
If the reviewed QC result is obtained from analysing the controls that are newly opened within the same
batch, the QC points of new bottles should be marked based on the following steps to differentiate the QC
analysis results of the controls in old bottles and new bottles:
(1) Move the green vertical line to the QC point of the first new bottle;
(2) Click New Bottle, and there will be a blue vertical line at the QC point of the new bottle;
(3) Open the controls within the same new bottle batch again and save its QC analysis results. Then click
Cancel New Bottle and cancel the original mark. And then mark the QC point of the new bottle according to
Step 1 and Step 2;
(4) If you want to print the currently compared parameter QC chart, please click Print;
(5) Click Close to exit.
If you want to change the display sequence of different parameter QC charts, please follow the steps below:
(1) Click Display Sequence, and the display sequence of the current QC charts will be provided;
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(2) Click the parameter that is desired to adjust the display order of the QC chart;
If you want to enter why the QC point is out of control, please follow the steps below:
(1) Click Out of Control after moving the green vertical line to the QC point desired to enter the reason for
loss of control. It will display the QC results, reference values and deviation limits of all parameters where
the green vertical lines lie (QC results that exceed the range of upper and lower limits will be marked in red)
and provide the function of entering the reason for loss of control;
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(2) The reason for loss of control can be selected from a list of provided reasons. Or one can manually enter
the reason for Loss of Control (200 characters max.) in the edit box after clicking the Others option;
(3) Click OK to save the entered reason for loss of control and exit.
Note:
After entering the reason for loss of control for a set of QC points of which the QC
results of parameters are within the deviation limits, the whole set of QC data will
be all marked in red that correspond to this set of QC points in QC chart/QC list. If
the reason for loss of control is cancelled and saved, the corresponding whole set of
QC data will be recovered and shown as black again.
8.3.3.1.6 Delete
With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
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(3) Click the data you want to delete;
(4) Click OK and confirm. All the selected data will be deleted.
Note:
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
(1) Enter the QC list interface by any one of the following methods:
1. Click QC in the shortcut button area;
2. Click Menu on the interface, and select QC X Mean QC in the pop-up menu;
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3. Enter X Mean QC Chart interface.
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(3) Select the file number of the QC files you want to review, and the interface will display corresponding file
information and QC list;
(4) Drag the scroll bar on the right of the QC list up and down to review the parameter QC result you want to
review. Drag the scroll bar below the QC list left and right to review all the QC results.
1 - Serial number of QC results saved in QC files (arranged from left to right and from old to new);
2 - QC results;
3 - QC parameter (the display order is in accordance with the QC chart interface);
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4 - QC warning signs:The results (average value X ) out of the set deviation limit range are marked with "↑"
or "↓" for prompting;
5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.
Note:
1. The value of the QC points represent the average values X of the QC analysis
results for each group.
2. For the QC files that store QC results, if the upper and lower limit ranges of some
parameters are changed when the reference values or deviation limits of these
parameters are modified and saved, the changed data will be highlighted in yellow.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
Click or , and the previous or the next QC result will be highlighted; Click or ,
and the first or the last QC result will be highlighted in the QC list.
8.3.3.2.3 Delete
With the administrator privilege, you may delete the QC results by following these steps:
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
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Note:
If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Export to provide the function of entering the file names of the exported path and related
data;
(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [Xaverage value_QC_Data saved date_time]);
(4) Select the file type of the exported data.(Default to .CSV);
(5) Click OK and start exporting;
(6) The interface prompts will prompt when the exporting has completed. Click OK to exit;
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Note:
You can modify the exported data if necessary, but you cannot check it through
Historical Review function.
If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;
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(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the backup data (default to: [Xaverage value_QC_Data saved date_time]);
(4) Click OK and start backup;
(5) The interface prompts that the backup is completed. Click OK to exit.
Note:
1. The backup data cannot be modified. You can check it through Historical Review
function.
2. You can click Cancel on the progress bar to cancel the backup during the backup.
If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;
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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;
(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;
(5) Click Close to exit after reviewing.
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8.4 X-B QC
8.4.1 QC principle
X-B floating average method, a method of monitoring the performance of the analyser by monitoring the
stability of RBC parameters of MCV, MCH, MCHC, etc. It belongs to the QC method without control.
Controls and it both belong to the means of performance monitoring of the analyser. They can respectively
reflect the analysis capability of the analyser from different sides but cannot replace each other.
When the daily sample size is greater than 100, and X-B QC is recommended for use. This QC method does
not apply to samples classified under the disease category because of random sampling. It has a reference
range composed of the given reference value and upper and lower limits and observes the change trend of QC
results within the reference range.
This analyser performs X-B QC for the following three parameters of MCV, MCH, MCHC. The sample size
of each group performing X-B numerical value analysis can be set to 20 - 200. The sample comes from the
normal counting results of the analyser. It does not distinguish between whole blood mode and predilution
mode. The analyser can save 500 X-B QC results at most. When the saved QC results exceed the maximum
number, the new QC result will replace the earliest result.
8.4.2 QC edit
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that come
into contact with these items have the potential of biological infection. Operators should
observe laboratory safety operation rules and wear personal protective devices (such as
laboratory protective clothing, gloves, mask, etc.) when touching relevant items and
regions in the laboratory.
Note:
Only the user of administrator level has the privilege to perform QC editing.
The editing of QC information should be completed by any of the following ways before QC analysis.
Manual entry;
Read saved preset value.
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2. Enter the X-B QC chart interface.
Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
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(3) Enter the selected number of sample results when counting one X-B QC points in the "Number of
Samples/Group" edit box. The selecting range is 20 - 200 and 20 is recommended.
(4) Click Open of X-B QC to open X-B QC. Take the effective result that the later sample counting obtained
as the required sample result of X-B QC analysis;
(5) Enter the reference value and deviation limits of the QC parameter;
Note:
2. Initial values of the reference values and deviation limits of the three QC
parameters will be provided by default in the beginning.
3. Users are not allowed to modify the reference value or deviation limit if QC
data has already existed in QC file.
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(2) Click Calculate by Absolute Value to display the deviation limit in the form of an absolute value; Click
Calculate by Percentage to display the deviation limit in the form of a percentage;
(3) If you choose to calculate by absolute value, click 2SD or 3SD, then the deviation limit will be calculated
according to 2 or 3 times of the SD; If you choose to calculate by percentage, click 2CV or 3CV, then the
deviation limit will be calculated according to 2 or 3 times of the CV;
(4) Click OK to save settings of deviation limits.
MCH: 30.5pg
MCHC: 340g/L
MCH: 0.9 pg
MCHC: 10 g/L
Note:
Default value reset is not allowed if QC data already exists in the QC file.
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8.4.3 QC analysis
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.
The system will automatically execute the operation of X-B QC counting after QC editing is completed.
The system will automatically execute the operation of X-B QC calculation one time every 20 - 200(based on
settings) effective sample results. The obtained QC results can be reviewed in the X-B QC chart or X-B QC
list.
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
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2. Enter the X-B QC chart interface.
(2) Drag the scroll bar below the QC chart left and right to review all the QC results.
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8.4.4.1.1 Introduction to QC chart interface
1 - Average value (Mean), standard deviations (SD) and coefficients of variation of all the QC results of all
the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - When clicking a QC point in the QC chart, mark this point and other QC points of the parameters, which
share the same save time, with green vertical lines;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.
Note:
1. The value of QC point is the X-B QC analysis result of each group of sample
results.
2. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
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Click or to move the green vertical line to the previous or next QC point; Click or
to move the green vertical line to the first or the last QC point of the QC chart. When the location of
the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.
8.4.4.1.3 Delete
With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
Note:
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.
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(1) Enter the QC chart interface in the following ways:
1. Click Menu on the interface and select QC X-B QC in the pop-up menu;
(2) Click QC List tab and enter the X-B QC list interface;
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(3) Drag the scroll bar below the QC list left and right to review all the QC results.
1 - QC results;
2 - QC result serial number saved in the QC files (arranged from left to right and from old to new);
3 - QC parameter (the display order is in accordance with the QC chart interface);
4 - QC warning signs:The results out of the set deviation limit range are marked with "↑" or "↓" for
prompting;
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5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.
Note:
The value of QC result is the X-B QC analysis value of each group of sample results.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
Click or , and the previous or the next QC result will be highlighted; Click or ,
and the first or the last QC result will be highlighted in the QC list.
8.4.4.2.3 Delete
With the administrator privilege, you may delete the QC results by following these steps:
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
Note:
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8.4.4.2.4 Data export
If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Export to provide the function of entering the file names of the exported path and related
data;
(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [X-B_QC_Data saved date_time]);
(4) Select the file type of the exported data.(Default to .CSV);
(5) Click OK and start exporting;
(6) The interface prompts that the exporting is finished. Click OK to exit.
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Note:
You can modify the exported data if necessary, but you cannot check it through
Historical Review function.
If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;
(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the backup data (default to: [X-B_QC_Data saved date_time]);
(5) The interface prompts that the backup is completed. Click OK to exit.
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Note:
1. The backup data cannot be modified. You can check it through Historical Review
function.
2. You can click Cancel on the progress bar to cancel the backup during the backup.
If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;
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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;
(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;
(5) Click Close to exit after reviewing.
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8.5 X -R QC
8.5.1 QC edit
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
Note:
Only the user of administrator level has the privilege to perform QC editing.
A QC file for each lot number of controls needs to be set before analysing a new batch of controls and the QC
information in the file can be edited through any one of the following methods.
Manual Entry.
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2. Enter the X -R QC chart interface.
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Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
Note:
(4) Input the lot number of the controls in one of the following ways;
Manual Entry
Input by using an external barcode scanner (not supported temporarily)
Note:
1. The lot number cannot be null. The input range is 1-16 characters. Characters,
numbers, letters and special characters are allowed except Chinese.
2. The lot number and QC mode of the QC file cannot be the same
simultaneously.
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Note:
The input range of expiry date is [the current system date, 2099-12-31]. It cannot
be null.
Note:
The lot number and QC mode of the QC file cannot be the same simultaneously.
8.5.2 QC analysis
You can select one of the following methods to perform QC analysis according to the QC mode selected after
editing the QC:
Whole blood
Predilution
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.)
when touching relevant items and regions in the laboratory.
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Warnings:
1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase
the risks of biological problems. Please be careful when operating the uncovered
blood collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood
collection tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to keep them from injury.
5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical
mask, etc.) when touching reagent-related items in the library.
6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty
of water and seek medical treatment from a doctor.
Note:
Note:
1. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
2. If the blood mode switches from "predilution" to "whole blood", the analyser
will execute mode switching fluidics sequence automatically and display the
progress bar prompt on the interface.
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2. Enter the X -R QC chart interface.
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Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "whole blood" and the counting status icon and state light of the analyser are
green;
2. Shake the prepared controls as shown in the following figure to thoroughly mix it;
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3. Click Start QC Counting;
4. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
5. Press the counting button to initiate the QC analysis;
6. The buzzer rings when the absorption process is completed. The user can then remove the controls;
7. When the analysis is finished, the interface will display the QC results of the first analysis;
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8. When the controls are mixed again, please perform the second QC analysis according to the prompts on the
interface;
Note:
You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.
9. The buzzer rings when the absorption process is completed. The user can then remove the controls.
(8) When the analysis is over, the QC results obtained (double the QC counting values and average values X ,
range R) will be displayed on the current interface and will be automatically saved in the current QC files;
Note:
1. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.
2. Each QC file can store 300 QC results (average values X and range R) at most.
(9) You may continue to perform QC analysis according to the steps above if necessary.
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
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Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
Warnings:
1. The probe is sharp, and may be stained with materials that are at risk of
biological contamination. Please be careful when operating the analyser. Do not
touch the probe.
2. The sample may spill out of the uncovered blood collection tube and increase the
risks of biological problems. Please be careful when operating the uncovered blood
collection tube.
3. The blood collection tube may cause personal injuries and/or increase risks of
biological problems if it breaks. Please be careful when putting the blood collection
tube in or removing it from the tube support to prevent damage.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to keep them from injury.
5. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical mask,
etc.) when touching reagent-related items in the library.
6. If the reagent gets in contact with the skin, please wash the effected area
immediately with plenty of water and seek medical treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty of
water and seek medical treatment from a doctor.
Note:
Note:
The operator must use disposable items specified by the company, such as vacuum
blood collection tubes, centrifuge tubes, capillaries, etc.
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2. Enter the X -R QC chart interface.
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Note:
Refer to Chapter 5 Settings for information about setting up a login user name.
(3) Select the QC file number to perform QC analysis. The interface displays corresponding file information;
(4) Confirm that the level of the controls to be analysed corresponds with that of the current QC file;
(5) Confirm the controls to be analysed has not yet expired;
(6) Prepare the controls according to its instructions;
(7) Perform QC analysis:
1. Confirm that the QC mode is "predilution" and the counting status icon and state light of the analyser are
green;
2. Click Add Diluent in the shortcut button area and the following prompt box will pop up;
3. When the preparation is completed, the following dialogue box will pop up;
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4. Take a clean centrifuge tube. Insert the probe vertically into the bottom of the centrifuge tube after opening
the cover as shown in the following figure to avoid producing bubbles, suspending liquid or spilling while
adding diluent;
6. The buzzer rings when the addition of diluent is completed. The user then can remove the centrifuge tube;
7. Collect 20μL of the controls and inject it into a centrifuge tube with diluent inside. Then fix the cover on
and thoroughly mix it;
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8. Click Cancel to exit the diluent addition dialogue box;
11. Put the controls under the probe to allow the needle to suck up the fully mixed controls;
12. Press the counting button to initiate the QC analysis;
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13. The buzzer rings when the absorption is completed. The user can remove the controls;
14. When the analysis is finished, the interface will display the QC results of the first analysis;
15. When the controls are mixed again, please perform the second QC analysis according to the prompts on
the interface;
Note:
You can cancel the second QC analysis by clicking Cancel in the dialogue box.
And the first QC analysis results won't be saved.
16. The buzzer rings when the absorption process is completed. The user can remove the centrifuge tube.
(8) When the analysis is over, the QC results obtained (double the QC counting values and average values X ,
range R) will be displayed on the current interface and will be automatically saved in the current QC files;
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Note:
2. Prevent dust from entering the prepared diluent, otherwise analysis errors may
arise.
3. After controls are fully reacted with the diluent, it needs to be laid for 3
minutes, and then mixed again before analysis.
4. Make sure to perform the analysis within 30 minutes after the sample is
diluted, otherwise the analysis results will be unreliable.
5. Samples that have been laid for a period of time need to be mixed again before
analysis.
8. When the second QC analysis results are obtained, the histogram and
scattergram displayed on the interface will be refreshed as the corresponding
figures of the second QC analysis results.
9. Each QC file can store 300 QC results (average values X and range R) at
most.
(9) You may continue to perform QC analysis according to the steps above if necessary.
Click or to switch the current QC result to the previous one or the next one of the current
result. Click or to switch the current QC result to the earliest saved result or the newest saved
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Note:
1. Expired QC analysis results will be marked with the letter "O" before it.
8.5.2.4 Print
Click Print and print the result on the current QC counting interface.
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
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2. Enter the X -R QC chart interface.
(2) Select the file number of the QC file you want to review, and the interface will display corresponding file
information and QC chart;
(3) Drag the scroll bar on the right of the QC chart up and down to review the parameter QC chart that you
want to review. Drag the scroll bar below the QC chart left and right to review all the QC results.
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8.5.3.1.1 Introduction to QC chart interface
1 - Average values (Mean), standard deviations (SD) and coefficients of variation (CV%) of all the QC results
of all the parameters in the current QC chart;
2 - The saved date and time of the QC point at which the green vertical line lies;
3 - The operator that performs QC analysis and obtains the QC point at which the green vertical line lies;
4 - The parameter QC results corresponding to the QC point at which the green vertical line lies;
5 - The QC points in each parameter QC chart are arranged from left to right and from old to new. All the QC
points are linked with lines, which makes it easy to view the distribution trend;
6 - The QC point corresponding to each QC result. Only the values of the selected QC points can be
displayed under the parameter. If the QC point is black, it means its value is within the upper and lower limits;
If the QC point is red, it means its value is out of the upper and lower limit range;
7 - When clicking a QC point in the QC chart, mark this point and the QC points of the parameters that are
saved at the same time with green vertical lines;
8 - Relative positions of the QC point at which the green vertical line lies among all the QC points as well as
the number of QC points that are currently saved.
Note:
2. The values of QC points are the average value X and range, R, of each group
of the QC analysis result respectively.
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3. Results that are out of control won't be included in the calculation of Mean, SD
and CV%.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
Click or to move the green vertical line to the previous or next QC point; Click or
to move the green vertical line to the first or the last QC point of the QC chart. When the location of
the green vertical line is fixed, the area below each QC parameter name will display the QC result of the QC
point at which the green vertical line lies.
If the reviewed QC result is obtained from analysing the controls that are newly opened within the same
batch, the QC points of new bottles should be marked based on the following steps to differentiate the QC
analysis results of the controls in old bottles and new bottles:
(1) Move the green vertical line to the QC point of the first new bottle;
(2) Click New Bottle, and there will be a blue vertical line at the QC point of the new bottle;
(3) Open the controls within the same new bottle batch again and save its QC analysis results. Then click
Cancel New Bottle and cancel the original mark. And then mark the QC point of the new bottle according to
Step 1 and Step 2.
If you want to compare the QC charts of the same parameter in different batches of controls, please follow
the steps below:
(1) Click Data Comparison, and the selection of QC chart is provided;
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(2) Select the files numbers of QC files that you want to compare in the File Number box in turn (3 file
numbers at most). The corresponding QC chart of the selected file number is displayed below the file number,
and its batch, QC mode and level are also displayed;
(3) You can select the QC charts of different parameters in the Parameter box to compare as required.
Note:
The display form and view method of the QC chart are in accordance with the QC
chart interface. The lines connecting QC points are grey, black and orange so as to
differentiate the QC charts of different levels of controls.
(4) If you want to print the currently compared parameter QC chart, please click Print (not supported
temporarily);
(5) Click Close to exit.
If you want to change the display sequence of different parameter QC charts, please follow the steps below:
(1) Click Display Sequence, and the display sequence of the current QC charts will be provided;
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(2) Click the parameter that is desired to adjust the display order of the QC chart;
If you want to enter why the QC point is out of control, please follow the steps below:
(1) Click Out of Control after moving the green vertical line to the QC point desired to enter the reason for
loss of control. It will display the QC results, reference values and deviation limits of all parameters where
the green vertical lines lie (QC results that exceed the range of upper and lower limits will be marked in red)
and provide the function of entering the reason for loss of control;
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(2) The reason for loss of control can be selected from a list of provided reasons. Or one can manually enter
the reason for Loss of Control (200 characters max.) in the edit box after clicking the Others option;
(3) Click OK to save the entered reason for loss of control and exit.
Note:
After entering the reason for loss of control for a set of QC points of which the QC
results of parameters are within the deviation limits, the whole set of QC data will
be all marked in red that correspond to this set of QC points in QC chart/QC list. If
the reason for loss of control is cancelled and saved, the corresponding whole set of
QC data will be recovered and shown as black again.
8.5.3.1.7 Delete
With the administrator privilege, you may delete the QC results by following these steps:
(1) If you want to delete a single QC result, please move the green vertical line to the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
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(3) Click the data you want to delete;
(4) Click OK and confirm. All the selected data will be deleted.
Note:
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
(1) Enter the QC list interface by any one of the following methods:
1. Click QC in the shortcut button area;
2. Click Menu on the interface, and select QC X -R QC in the pop-up menu;
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3. Enter the X -R QC chart interface.
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(3) Select the file number of the QC files you want to review, and the interface will display corresponding file
information and QC list;
(4) Drag the scroll bar on the right of the QC list up and down to review the parameter QC result you want to
review. Drag the scroll bar below the QC list left and right to review all the QC results.
1 - Serial number of QC results saved in QC files (arranged from left to right and from old to new);
2 - QC results;
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3 - QC parameter (the display order is in accordance with the QC chart interface);
4 - QC warning signs:If you have gained 10 groups of QC analysis results (obtained after 20 QC analyses),
the results (average values X ) that are out of the set deviation limit range will be marked with an "↑" or "↓"
for prompting;
5 - The relative location of highlighted QC results among all the QC results and the number of QC results
saved currently.
Note:
1. The grand mean, average range and warning prompt of each parameter are provided
only when 10 groups of QC analysis results (obtained after 20 QC analyses) are
obtained.
2. The values of QC results are the average values X and range R of each group of the
QC analysis results.
If you want to browse the QC results saved in the current QC file, please click the arrow button at the lower
part of the interface:
Click or , and the previous or the next QC result will be highlighted; Click or ,
and the first or the last QC result will be highlighted in the QC list.
8.5.3.2.3 Delete
With the administrator privilege, you may delete the QC results by following these steps.
(1) If you want to delete a single QC result, then click the column which contains the QC result you want to
delete; If you want to delete all the data of a current QC file, please perform Step 2 directly;
(2) Click Delete to select whether to delete the current data or all data;
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Note:
If you want to export the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Export to provide the function of entering the file names of the exported path and related
data;
(2) Select the exported path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
(3) Enter the file name of the exported data (default to: [Xaverage value-R_QC_Data saved date_time]);
(4) Select the file type of the exported data.(Default to .CSV);
(5) Click OK and start exporting;
(6) The interface prompts that the exporting is finished. Click OK to exit.
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Note:
You can modify the exported data if necessary, but you cannot check it through
Historical Review function.
If you want to backup the QC information and the QC results of the current QC file, please follow the steps
below:
(1) Click Data Backup, and the function of entering the file names of backup path and data is provided;
(2) Select a backup path (saved in the folder named "QC_Data" in the installation directory of the terminal
software by default);
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(3) Enter the file name of the backup data (default to: [Xaverage value-R_QC_Data saved date_time]);
(4) Click OK and start backup;
(5) The interface prompts that the backup is completed. Click OK to exit.
Note:
1. The backup data cannot be modified. You can check it through Historical Review
function.
2. You can click Cancel on the progress bar to cancel the backup during the backup.
If you want to check the backup data, please follow the steps below:
(1) Click Historical Review and a dialogue box shown below will pop up;
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(2) Select the file name of the backup data you want to browse after selecting the directory where the backup
data exists;
(3) Click OK to display the selected backup data;
(4) The display forms of file information and result list as well as the button function are the same as the QC
list interface. If you want to view and print (not supported temporarily) the results in the list or export data,
you can refer to the operation methods in the QC list interface;
(5) Click Close to exit after reviewing.
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8.6 Repeatability
Please follow the following steps to compete the repetitive operation:
(1). Click Menu on the interface, and select QC Repeatability in the pop-up menu;
(2) Click Start and the following dialogue box will appear:
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(3) Select the blood mode that needs to undergo a repeatability test; click OK and a dialogue box will pop up.
Press the counting button on the analyser and the progress bar dialogue box will pop up.
Note:
Once the operator clicks Start and presses the counting button to start the first
counting, the Start button turns grey. After this, the operator can press the
counting button on the analyser directly and continue the repetitive counting.
(4) If the operator switches the interface before calculating new reproducibility, a prompt dialogue box will
pop up.
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Click Yes, and the existing repetitive statistics will be abandoned. Close the prompt dialogue box and switch
to another interface. The original reproducibility won't be changed.
(5) When effective repetitive counting accumulatively reach n times (n ≥ 4), the analyser will automatically
calculate average values Mean, SD and CV% of all the repetitive data selected by “√” (the calibration data for
the first counting has no “√”, so it won't be calculated);
(6) When obtaining new reproducibility, please follow the steps shown below:
8.6.1 Save
(1) Click Save and a dialogue box will pop up:
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8.6.2 Data export
(1) Click Data Export and a dialogue box will pop up:
(2) Select a path for exporting the data. Click Save and a dialogue box will pop up:
(3) Click OK and close the dialogue box.
Note:
You can modify the exported data if necessary, but you cannot check it through
Historical Review function.
8.6.3 Exit
(1) Click Exit and a prompt dialogue box will pop up:
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(2) Click Yes, save the reproducibility, and a prompt dialogue box will pop up:
(3) Click Yes, exit the current repetitive interface and switch to another interface.
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(2) Click Start and the following dialogue box will appear:
(3) Press the counting button on the analyser, and the information/status bar will show that the carryover is
being calculated;
Note:
Once the operator clicks Start and presses the counting button to start the first
counting, the Start button turns grey. After this, the operator can press the counting
button on the analyser directly and continue the carryover counting.
(4) Perform blood sample counting 3 times first, and then perform diluent counting 3 times. The analyser
will calculate the carryover automatically based on formulas;
(5) The carryover is calculated. Then judge the state according to the diluent range and carryover range:
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8-115
Calibration
Chapter 9. Calibration
9.1 Overview
Like all the other measuring instruments, LW D6500 Five-differential Haematology Analyser must be
calibrated periodically. Performing calibration is to get correct measuring results and determine the offset
correction factor of the blood sample analysis at prescribed conditions. To get correct blood sample analysis
results, the analyser should be calibrated according to the steps given in this chapter if needed.
Note:
2. The operator should use the controls and reagents specified by the company, and
store and use them in strict accordance with the manual.
Note:
The measuring data can be used effectively only after the analyser is calibrated.
9-1
Calibration
9.3.1 Preparation
Perform inspection according to the following steps before calibration. The calibration can only be performed
when the normal background, Reproducibility and carryover of the analyser are confirmed within the
manual-specified ranges. Otherwise, you must find out the reasons and then decide whether calibration needs
to be performed when the problem is solved. If the problem cannot be solved, please contact with the
after-sales service department of Landwind Company.
(1) Check the analyser and reagents, and make sure that the amount of the reagent is sufficient to complete
the whole calibration. If the reagent is used up during the calibration, you need to recalibrate.
(2) When performing the background test, if the "Abnormal background" prompt appears at the bottom of the
screen, please refer to Chapter 11 Troubleshooting for handling so as to make sure the results of the
background test meet requirements. (Refer to Appendix B Specifications for normal background).
Perform 11 times of counting in a row in the whole blood -CBC+DIFF pattern with median controls. Take the
counting results from the second to the eleventh, and view the repetitiveness of counting results from the
second to the eleventh in List Review interface to make sure that the repetitiveness are within the range
specified by the table below.
Parameters Ranges Repetitiveness Repetitiveness
of whole blood of prediluted sample
sample (CV) (CV)
(3) Count 3 times with high value controls, and count 3 times immediately with matched diluent. Then
calculate the carryover according to the formula below.
Carryover (%) = the first sample result wit h low value - the third sample result wit h low value
100%
the third sample result wit h high value - the third sample result wit h low value
Parameters Carryover
9-2
Calibration
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
HCT ≤0.5%
PLT ≤1.0%
(4) We recommend that the operator creates a log file, turns it into a log sheet and saves it. The contents of
the log sheet is recommended to include the following items:Date, calibrators source, lot number and its
reference value, as well as background test value.
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
Warnings:
1. Probe head is pointed. Blood samples, controls and calibrators on the probe have
a potential of biological infectivity. Avoid touching the probe.
2. The reagent will cause irritation to eyes, skin and mucous membranes. Operators
should observe laboratory safety operation rules and wear personal protective
equipment (such as laboratory protective clothing, gloves, surgical mask, etc.)
when touching reagent-related items in the library.
3. If the reagent touches the skin, please wash the affected area immediately with
plenty of water and seek medical treatment if necessary. If the reagent gets in
contact with the eyes, please wash them immediately with plenty of water and seek
medical treatment from a doctor.
4. Please keep a distance between the moving parts and your clothes, hair and
hands, etc. to prevent injuries.
5. Operators have an obligation to observe the relevant provisions of the region and
country when discharging and disposing of expired reagents, wastes, waste
samples, consumables, etc.
Note:
9-3
Calibration
Note:
1. The operator should use the calibrators and reagents specified by the company,
and store and use them in strict accordance with the manual.
2. The operator must use disposable items specified by the company, such as
vacuum blood collection tubes, centrifuge tubes, capillaries, etc.
Note:
The operator logged in with a common user identity can only view the calibration
factors of the current interface and cannot perform calibration. If he wants to
calibrate the analyser, he should log out, and log in again with the administrator
identity.
(2) The operator enters Calibration Factor interface to view the calibration factor and calculate new
calibration factors for each calibration factor using the following formulas.
9-4
Calibration
For example:Suppose that the WBC reference value of calibrators is 8.4, and the calibration factor of the
current whole blood mode is 98.90%.
Measure the WBC parameter of the calibrators in the whole blood mode 11 times. Take the results from the
second to the eleventh (n=10), with the results of 8.1, 8.0, 8.1, 8.1, 8.3, 8.3,8.2, 8.0, 8.1 and 8.3, and obtain
the reproducibility, CV=1.5%, Mean=8.16. The requirements are met, and the measured average value is
effective.
Calculate new calibration factor:
98.90% 8.4
New calibratio n coefficien t = =101 .81%
8.16
If the calculated calibration factor of a parameter is out of the effective range (75.00% - 125.00%), the
coefficient is ineffective. In this case, the operator should find out the reason (the sample hasn't been fully
mixed or incorrect operation, etc). Calibrate again and calculate the calibration factor.
Note:
The input calibration factor should be in the range of 75.00% - 125.00%, and
only two decimal digits are retained.
(3) After getting a new calibration factor, the operator inputs the new calibration factor in the calibration
factor cell that needs to calibrate parameters:
(4) After inputting the new calibration factor, click Save below the interface. If the new calibration factor is
effective, and the value is not the same as the original one, a prompt dialogue box will pop up.
Click OK and save the new calibration factor. Meanwhile, the calibration date of the corresponding
calibration parameter is refreshed to the current system date. Then close the prompt dialogue box above,
return to the calibration factor surface, and don't highlight any cells.
If the new calibration factor is ineffective, click Save and a prompt dialogue box will pop up.
9-5
Calibration
Click OK and close the prompt dialogue box. Highlight the cell of the first ineffective calibration factor. Edit
the data in it, but don’t empty it.
(5) If you switch the interface before clicking Save when the calibration factor is modified, a corresponding
prompt will appear when you exit.
If the new calibration factor is effective, a prompt dialogue box will pop up when you exit the interface.
Click OK and save the new calibration factor. Meanwhile, the calibration date of the corresponding
calibration parameter is refreshed to the current system date and recorded into the calibration history. Then
close the prompt dialogue box and switch to another interface.
If the input calibration factor is ineffective, a prompt dialogue box will pop up when you switch the interface.
Click OK and close the prompt dialogue box. Switch to another interface directly and don't save the modified
calibration factor and corresponding calibration date, that is, the calibration factor and date are the values
displayed when entering the calibration factor interface.
9-6
Calibration
Note:
1. The default expiry date of the analyser is the current system time.
(3) Input the lot number of the current calibrators in Lot Number edit box;
(4) Set the expiry date. The default reagent expiry date of the analyser is the current date. If you want to
modify it, please click Expiry Date edit box to reset it;
(5) Select the parameter that needs to be calibrated in the check box of the first line of the list;
9-7
Calibration
(6) Input the target value of the parameter that needs to be calibrated in the edit box corresponding to Target
Value.
Biological risk:
All items (samples, controls, calibrators, reagents, wastes, etc.) and regions that
come into contact with these items have the potential of biological infection.
Operators should observe laboratory safety operation rules and wear personal
protective devices (such as laboratory protective clothing, gloves, mask, etc.) when
touching relevant items and regions in the laboratory.
Note:
1. The operator must use the calibrators specified by the company and dedicated to
this analyser. The company won't be responsible for incorrect analysis results caused
by using other calibrators.
2. Refer to the operation manual of calibrators for its lot number, expiry date and
parameter target value.
3. The lot number cannot be null.
4. The expiry date cannot be less than the current system date.
5. The expiry date entered by the operator should be the expiry date of calibrators
opening date + date after seal of calibrators, or the expiry date specified on the
operation manual of calibrators. If these two are unequal, choose the smaller one to
make sure that the calibrators are always within the expiry date range when using.
Note:
Once the operator clicks Start Calibration Counting and presses the counting
button to start the first counting, the Start Calibration Counting button turns grey.
9-8
Calibration
After this, the operator can press the counting button on the analyser directly and
continue the calibration counting.
(9) When each calibration counting is finished, the progress bar dialogue box of calibration counting will
close automatically. The analyser will perform different processing depending on different calibration
counting results;
Among the current counting, if the calibration counting data of a parameter is out of its linearity range but
within the display range, then the calibration data will be displayed in the list and a prompt dialogue box will
pop up.
Click OK and the dialogue box closes. The calibration data displayed in the list this time will be deleted
automatically and the calibration data won’t be saved this time.
Among the current counting, if the calibration counting data of a parameter is out of its display range, it is
displayed as *** (*** is displayed based on the data format of each parameter) in the list. Meanwhile, a
prompt dialogue box will pop up.
Click OK and the dialogue box closes. The calibration data displayed in the list this time will be deleted
automatically and the calibration data won’t be saved this time.
If the calibration counting result is within the linearity range, it is recognized as effective and will be
displayed directly.
9-9
Calibration
Note:
When an effective calibration counting result is obtained, the check box before it
will turn into “√” state. It will be included in the calibration factor calculation by
default.
(10) If the operator switches the interface before calculating new calibration factor, a prompt dialogue box
will pop up;
Click Yes, and the existing calibration data will be abandoned. Close the prompt dialogue box and switch to
another interface. The original calibration factor won't be changed.
(11) When effective calibration counting accumulatively reaches n times (n ≥ 6), the analyser will
automatically calculate average values Mean, CV% and new calibration factors (the calibration data for the
first counting has no “√”, so it won't be calculated) of all the calibration data selected by “√”;
The operator can select several groups of data to calculate the calibration factor. However, the calibration
factor can only be calculated when the number of the data groups selected by “√” is above 5. When clicking
the “√” of the check box or .cancelling the data with “√”, the calibration factor will be refreshed and
displayed in time.
Note:
1. If the CV% value is over the limit, it won't affect the display of the calibration
factor.
2. When the number of the effective calibration data points in the list reaches 11,
"The calibrators calibration this time has been fully completed!" will pop up
immediately. If one alarm sound emits "Tick" after the counting button on the
analyser is pressed, the counting won't be responded.
(12) When a new calibration factor is obtained, the operator switches the interface. Several situations are
distinguished as follows:
If the calibration factor of any parameter that has been calculated and needs to be calibrated is out of the
range of 75%-125%, i.e. <75% or >125%, or the CV% value of any calibration parameter exceeds the
reproducibility of the analyser, then the coefficient values of all the parameters that need to be calibrated
won't be saved, and a prompt dialogue box will pop up.
9-10
Calibration
Click Yes, close this prompt dialogue box and switch to another interface. Meanwhile, the calibration factor
and calibration date of each calibration parameter isn't modified.
If all the calculated calibration factors are within the range of 75%-125% (i.e. >=75% and <=125%), and the
CV% values of all calibration parameters don't exceed the reproducibility of the analyser, a prompt dialogue
box will appear.
9-11
Calibration
(3) Refer to the sample preparation methods in Chapter 6 Daily operation and prepare 3 - 5 shares of normal
fresh blood samples;
(4) Take 3 - 5 shares of prepared normal fresh blood, and measure them at least 3 times on the reference
instrument respectively. Calculate the average values, and turn the average values into reference values; Or
conduct measurements and calculations based on the reference method, and consider the obtained data as
reference values;
(5) Click the two radio buttons of Whole blood and Predilution on the top of the interface, and select a
calibration mode of fresh blood calibration;
Note:
(6) Select the number of the current calibration blood samples in the drop-down list box of Current Blood
Sample ID;
(7) Select the parameter that needs to be calibrated in the check box of the first line of the list;
(8) Input the reference value of the parameter that needs to be calibrated in the edit box corresponding to the
Reference Value.
(9) Prepare the fresh blood samples of whole blood or predilution;
(10) After clicking Start Calibration Counting, press the counting button on the analyser, initiate the
calibration counting fluidics sequence, and a progress bar dialogue box will pop up;
9-12
Calibration
Note:
Once the operator clicks Start Calibration Counting and presses the counting
button to start the first counting, the Start Calibration Counting button turns grey.
After this, the operator can press the counting button on the analyser directly and
continue the calibration counting.
(11) When each calibration counting is finished, the progress bar dialogue box of calibration counting will
close automatically. The analyser will perform different processing depend on different calibration counting
results;
If the calibration counting result is out of the linearity range but within the display range, the calibration
counting result will be displayed in the list, and meanwhile, a prompt dialogue box will pop up.
Click OK and the dialogue box closes. The calibration result displayed in the list this time will be deleted
automatically and the calibration result won’t be saved this time.
If the calibration counting result is out of the display range, the calibration counting result in the list will be
displayed as *** (*** is displayed according to the data format of each parameter) and a prompt dialogue box
will pop up.
9-13
Calibration
Click OK and the dialogue box closes. The calibration result displayed in the list this time will be deleted
automatically and the calibration result won’t be saved this time.
If the calibration counting result is within the linearity range, it is recognized as effective and will be
displayed directly.
Note:
When an effective calibration counting result is obtained, the check box before it will
turn into “√” state. It will be included in the blood sample calibration factor
calculation by default.
(12) For each blood sample, when effective calibration counting accumulatively reaches n times (n ≥ 6), the
analyser will automatically calculate average values Mean, CV% and blood sample calibration factors (the
calibration data for the first counting has no “√”, so it won't be calculated) of all the calibration data selected
as indicated by “√”;
The operator can select several groups of data to calculate the blood sample calibration factor. However, the
blood sample calibration factor can only be calculated when the number of the data groups selected as
indicated by “√” is above 5. When clicking the “√” of the check box or cancelling the data with “√”, the
blood sample calibration factor will be refreshed and displayed in time.
Note:
1. If the CV% value is over the limit, it won't affect the display of the blood sample
calibration factor.
2. When the number of the effective calibration data in the list reaches 11, " The
calibrators calibration this time has been fully completed!" will pop up immediately.
If one alarm sound emits "Tick" after the counting button on the analyser is pressed,
the counting won't be responded.
(13) Select other calibration blood samples in the drop-down list box of Current Blood Sample ID,
complete the counting of other calibration blood samples referred to in Step 8 - Step 12 found above, and
obtain the calibration factor of each blood sample.
9-14
Calibration
Note:
If you have selected some parameters to calibrate, then when switching to other
blood sample, the grey parameter column will remain grey.
Click Yes, and empty the input reference values of the current blood sample, all the existing calibration data
and all the counting values, including calibration factors. Then close the prompt dialogue box, and switch to
other blood samples.
If new calibration factor of this blood sample hasn't been calculated, a prompt dialogue box will pop up.
Click Yes, and empty the input reference values and all the existing calibration data. Then close the prompt
dialogue box, and switch to other blood samples directly.
If the calibration factor of this blood sample is within the effective range, and the CV% values of all
calibration parameters don't exceed the reproducibility of the analyser, then direct switching is allowed, and
no prompt will pop up.
(15) Click Calculation in the interface to enter the fresh blood calibration calculation interface after
obtaining at least 3 calibration factors of fresh blood samples;
9-15
Calibration
Click the check box in front of each blood sample calibration factor, then select or cancel the calibration
factor of the blood sample for the calculation of average calibration factor.
When the calibration factors selected with “√” are greater than or equal to 3 groups, the CV% value among
the calibration factors will be recalculated according to the calibration factors selected with “√”.
Note:
The CV% value will not affect the display of the average calibration factor no matter
whether it is above limit or not.
When the calibration factors selected with “√” are greater than or equal to 3 groups, the average calibration
factor will be recalculated automatically according to the current calibration factors selected with “√”.
(16) If the average calibration factor has not been calculated, then a dialogue box will pop up when switching
from the fresh blood calibration interface or calibration mode.
Click Yes to abandon the existing calibration data and close the prompt dialogue box to switch to another
interface or calibration mode. The original calibration factor and date will not be changed.
9-16
Calibration
(17) If the calculated average calibration factor is within the effective range, a prompt dialogue box will pop
up when switching from the fresh blood calibration interface, or calibration mode.
Click Yes to save the current average calibration factor and the calibration factor and calibration date in the
calibration factor list in the "Calibration Factor" interface will automatically be updated at the same time. And
then switch to another interface or calibration mode; Click No so the average calibration factor and all the
calibration data will not be saved. Close the prompt dialogue box directly, switch to another interface or
calibration mode.
9-17
Services
10.1 Overview
To ensure the analyser can run accurately and effectively, operators should conduct daily maintenance on the
analyser according the requirements in this chapter. This analyser provides several maintenance functions to
help the operators complete the maintenance.
This chapter introduces the maintenance functions of the analyser and some handling measures adopted
should failures and alarms happen.
Biological risk:
The surfaces of all the analyser components are potentially infectious. Safety
protection measures should be taken during operations and maintenance.
Cautions:
3. The analyser must be maintained using the spare parts provided by Landwind
Company. Please contact the after-sales department of Landwind Company should
there be any question.
4. Please avoid touching the sharp needlepoint of the probe during maintenance.
10.2 Maintenance
Note:
1. The analyser will not enter sleep during self-testing of motor, self-testing of valve
or in status interface.
10-1
Services
2. The analyser will not enter sleep should there be any failure affecting the sleep.
Click Menu in the interface and select Instrument Instrument Sleep in the pop-up menu.
When the sleep preparation has been completed, the progress bar dialogue box in the figure above will close
automatically and the analyser will enter sleep.
10-2
Services
Note:
1. The counting status icon in the interface will stay as yellow after the analyser has
entered sleep. The state light on the analyser will also stay as red at this time.
2. Sample analysis cannot be performed when the analyser has entered sleep.
4. The analyser will not enter sleep status should there be any failure during the
sleep process and failure will be reported at the same time. Please refer to Chapter
11 Troubleshooting for troubleshooting methods.
Note:
The analyser will perform different levels of maintenance when exiting sleep
according to the duration of sleep time. Meanwhile, the maintenance time will be
different.
10-3
Services
After cancelling the sleep, the progress bar dialogue box in the figure above will close automatically, and the
analyser will exit sleep.
Counting button
Press the counting button on the analyser directly to cancel the sleep.
10-4
Services
After waking up the instrument, the progress bar dialogue box in the figure above will close automatically,
and the analyser will exit sleep.
Note:
2. The analyser will restore to the status before the sleep automatically after exiting sleep
normally. The counting status icon in the interface will stay as green at this time. The
state light on the analyser will also stay as green at the same time.
Warnings:
1. The reagent will cause irritation to the eyes, skin and mucous membranes.
Operators should observe laboratory safety operation rules and wear personal
protective equipment (such as laboratory protective clothing, gloves, surgical mask,
etc.) when touching reagent-related items in the library.
2. If the reagent has made contact with skin, please flush the affected area with
plenty of water immediately and seek a doctor’s treatment if necessary; If the
reagent gets in contact with the eyes, please wash them immediately with plenty of
water and seek medical treatment from a doctor.
Note:
10-5
Services
In the following situations, Users need to replace reagents in the following situations:
Replace new reagents;
Suspect the reagent tube has been polluted;
Reagent has been polluted or expired;
Suspect there is bubble in the tube.
Click in the shortcut button area or click Menu. Select Service Maintenance -> Reagent
Replacement in the pop-up menu and enter the interface as shown in the figure below.
10-6
Services
Note:
(2) The lot number and expiry date of the reagent to be replaced can be input after clicking Replace New
Bottle radio button:
(3) Click OK, save the input expiry date and lot number, and begin to replace the reagent:
(4) The operation/status information bar will prompt that the reagent replacement is done upon completion:
(5) You can continue to replace other reagents according to the steps above if necessary.
10.2.4 Cleaning
Users are required to clean the corresponding components in the following situations:
The WBC cuvette can be cleaned if the background results of WBC and (or) HGB exceed the normal
background;
The RBC cuvette can be cleaned if the results of RBC and (or) PLT exceed the normal background;
The DIFF cuvette can be cleaned if there are many particles in the scattergram of the background
results;
The flow cell can be cleaned if there are many particles in the scattergram of the background results or
the results of WBC classifications are not satisfying;
The probe can be cleaned if it is dirty.
10-7
Services
Click in the interface, then click Clean tab in the pop-up interface and enter the interface as shown
below.
10.2.5 Maintenance
The maintenance of the instrument includes: The rear of cuvette branch cell cleanser immersion, unclogging
apertures, zapping apertures, flushing apertures, DIFF cuvette immersion, WBC cuvette immersion, RBC
cuvette immersion, whole machine cell cleanser immersion, DIFF cuvette emptying, WBC cuvette emptying,
RBC cuvette emptying, etc.
10.2.5.1 The rear of cuvette branch cell cleanser immersion
Users can perform The rear of cuvette branch cell cleanser immersion immersion in the following situations:
10-8
Services
When the instrument has performed counting for about 1500 times;
After the clogged apertures have been solved.
Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.
(2) Click Yes and a prompt dialogue box will pop up. Please place the cell cleanser under the probe and press
the counting button;
10-9
Services
(3) After absorbing the cell cleanser as prompted, a progress bar dialogue box will pop up as shown below
and the absorption of cell cleanser will begin;
Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.
10-10
Services
Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.
10-11
Services
Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.
10-12
Services
Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.
10-13
Services
(2) Click Yes and a prompt dialogue box will pop up. Please place the cell cleanser under the probe and press
the counting button;
10-14
Services
(3) After absorbing the solution for the first time as prompted, a progress bar dialogue box will pop up as
shown below and the absorption of cell cleanser will begin;
(4) The progress bar dialogue box will close automatically and a prompt dialogue box will pop up at the same
time;
(5) The operation/status information bar will indicate that the instrument is immersing in the cell cleanser
after absorbing the cell cleanser for the second time. Please wait for a moment;
(6) The option to stop the immersion manually will pop up after 5 minutes. Click Stop Immersion or wait for
the instrument to finish the immersion automatically;
(7) The immersion will continue for 20 minutes. The operation/status information bar will then prompt that
probe immersion has successfully been completed;
10-15
Services
(8) You may continue to perform cell cleanser immersion according to the steps above if necessary.
Click in the interface, then click Maintenance tab in the pop-up interface and enter the interface as
shown below.
The steps for cell cleanser immersion of DIFF cuvette are as shown below:
(1) Click DIFF Cuvette Immersion icon and a dialogue box will pop up as below;
(2) Click Yes and a prompt dialogue box will pop up;
10-16
Services
(3) Proceed according to the prompts and a progress bar dialogue box will pop up as shown below. The cell
cleanser is being absorbed;
(4) The operation/status information bar will indicate that the instrument is immersing in the DIFF cuvette
after absorbing the cell cleanser. Please wait for a moment;
(5) The option to stop immersing will pop up. Click to stop immersion or wait for the instrument to finish
immersing automatically;
(6) The operation/status information bar will prompt that the DIFF cuvette immersion has successfully been
completed;
10-17
Services
Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.
10-18
Services
Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.
Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.
10-19
Services
(2) Remove diluent and lyse tubes and place them in an empty beaker, then click OK to perform the
emptying operation;
(3) A dialogue box will be displayed as shown below when the emptying has been completed. Users should
turn off the power of the analyser as prompted in the interface;
10-20
Services
Note:
1. This software can still be used after emptying has been completed.
2. When the dialogue box prompts to turn off the power of the instrument, the
analyser will restart if Restart is clicked.
Click in the interface, and click Whole Machine Maintenance tab in the pop-up interface to enter
the interface as shown below.
(1) Click Prepare to ship and a dialogue box will pop up as shown below;
(2) Remove diluent and lyse tubes and place them in an empty beaker, then click OK to perform the
emptying operation;
(3) The interface will continue to pop up the prompt dialogue box as shown below when the emptying has
been completed;
(4) Remove diluent and lyse tubes from the beaker and place them in a beaker filled with distilled water, then
click OK to perform priming;
(5) A prompt dialogue box will be displayed again as shown below when the prime has been completed;
(6) Remove diluent and lyse tubes from the beaker with distilled water and place them back in the original
empty beaker, then click OK to perform emptying again;
10-22
Services
(7) A prompt dialogue box will pop up as shown below when the emptying has been completed. Users should
turn off the power of the instrument on the analyser end as prompted in the interface.
Note:
1. This software can still be used after preparing to ship has been completed.
2. When the dialogue box prompts to turn off the power of the instrument, the
analyser will restart if Restart is clicked.
10.2.7 Auto-cleaning
The analyser will perform auto-cleaning and prompt in the interface when sample counting has been
accumulated to 100 times.
Note:
1. When the conditions of auto-cleaning have been met but the analyser is
running or has failure, it will perform auto-cleaning again after the current
operation or troubleshooting has been completed.
2. All the counting cumulative values of auto-cleaning will be reset to "0"
automatically after auto-cleaning, probe cleanser soaking or powering off.
3. Scheduled auto-cleaning will be performed in self-testing and status
interfaces (for more than an hour).
10-23
Services
(2) Click Yes and a prompt dialogue box will pop up. Please place the cell cleanser under the probe and press
the counting button;
(3) After absorbing the solution for the first time as prompted, a progress bar dialogue box will pop up as
shown below and the absorption of cell cleanser will begin;
(4) The progress bar dialogue box will close automatically and a prompt dialogue box will pop up at the same
time;
10-24
Services
(5) The operation/status information bar will indicate that the instrument is immersing in the cell cleanser
after absorbing the cell cleanser for the second time. Please wait for a moment;
(6) Click Stop Immersion or wait for the instrument to finish immersing automatically when immersion has
started;
(7) The immersion will continue for 15 minutes. The operation/status information bar will then prompt that
probe immersion has successfully been completed.
Note:
10-25
Services
The operation/status information bar will prompt after the analyser has entered sleep.
Note:
1. The waiting time to automatically enter sleep can be set. Please refer to
Chapter 5 Settings for details.
2. It will not enter sleep in self-testing and status interfaces.
3. When it is time for timed sleep, if the analyser is in failure status, then it will
determine whether to enter sleep after troubleshooting the failure.
4. Operations not related to the analyser, such as communications, printing, etc.,
will not be affected during timed sleep.
Note:
If the status inspection value exceeds the normal range, then it will be highlighted
with red background.
10-26
Services
Click Voltage and Current tab to enter the interface as shown below.
Users can check the voltage and current information of the instrument and also export or print the above
information.
10-27
Services
Click Temperature and Pressure tab and a prompt dialogue box will pop up
The prompt dialogue box will be closed automatically and the interface will be displayed as shown below
after the fluidics sequence has been completed.
10-28
Services
Users can check the temperature and pressure information and also export or print the above information.
A dialogue box as shown below will pop up and the analyser will perform pressure relief after the enquiry has
been completed and entered the interface other than the current temperature and pressure interface. The
analyser will not perform pressure relief when switching between the temperature and pressure interface and
failure management interface.
10-29
Services
Users can check the version and configuration information and also export or print the above information (not
supported temporarily).
10-30
Services
10.5 Self-testing
Click Syringe and Probe tab to enter the interface as shown below.
10-31
Services
10-32
Services
Note:
10-33
Services
Note:
You can try again several times after clicking OK if abnormal self-testing results
are prompted. And please contact our after-sales service department or your local
agent to resolve the issue if self-testing results are still abnormal.
You can continue to test other items according to the steps above if necessary.
10.6 Counter
Click Menu in the interface, and select Service Counter in the pop-up menu.
10-34
Services
Users can check the statistical information of above items and detailed statistical information of some of the
following items above.
Check the detailed information
Users can check the detailed information related to the number of times that sample counting, QC and
calibration occurred.
10-35
Services
Click Detailed Information behind Times of Sample Counting. The interface displays the detailed
statistical results of the number of times of sample counting.
Click Detailed Information behind Times of QC. The interface displays the detailed statistical results of the
number of times of QC.
Click Detailed Information behind Times of Calibration. The interface displays the detailed statistical
results of the number of times of calibration.
10-36
Services
10.7 Log
Note:
1. System will automatically cover the oldest record if the log is full when
adding new records.
2. Logs not more than a year can be stored.
3. No more than 100 characters can be entered in the comment section.
10-37
Services
Users can check above log information, enter comment information and execute query operations.
Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.
Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.
10-38
Services
Users can check above log information, enter comment information and execute query operations.
Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.
10-39
Services
Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.
Note:
The failure information is visible only for administrators or people who have been
granted permission to view such information.
Click Menu in the interface, and select Service Log in the pop-up menu.
10-40
Services
Users can check above log information, enter comment information and execute query operations.
Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.
Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.
Note:
The total of all log information, which is visible for users of the current level, is
displayed in All Logs tab.
Click Menu in the interface, and select Service Log in the pop-up menu.
10-41
Services
Users can check above log information, enter comment information and execute query operations.
Comments
(1) Enter the comment information in Comment bar that corresponds to log records desired;
(2) Click Save on the lower part of the interface to save.
Query
The operator can enter the query conditions on the lower part of the interface. Click Query, the Log
Information bar will display the information required.
10-42
Troubleshooting
11.1 Overview
This chapter will introduce potential failure information to the analyser and will provide
corresponding processing methods.
Note:
11-43
Troubleshooting
The failure list provides the arisen failure name and failure help information. The failure name
will be displayed in the order of the failure occurs.
The operator can select it (highlighted) by clicking the failure name in the failure list. The help
information of the selected failure can be checked in the right side of the list of "Failure
Information" and "Help Information". The operator can perform failure procedures according to
the content of failure help.
The following functions are provided in current dialogue box:
Failure elimination
Click One-key Failure Elimination, a dialogue box will be as shown below:
The software will eliminate any failures that can be automatically eliminated. For failures that
cannot be automatically eliminated, the operator can perform corresponding failure procedures
according to the failure help information.
Mute
Clicking Mute will cease the alarm sound of the analyser.
The possible failure of the analyser and corresponding help information are as shown in the table
below:
11-44
Troubleshooting
Voltage exception 1. Please power off the analyser according to the normal
procedure first, and then restart it.
Sheath flow channel blockage 1. Click One-key Failure Elimination to automatically remove
this failure.
Ambient temperature exceeds 1. Please ensure that the ambient temperature is in the normal
working temperature range range of [15, 30]℃.
11-45
Troubleshooting
Ambient temperature exceeds 1. Ambient temperature exceeds the allowable range of counting
running temperature range [10, 40] ℃.
L-65LEO I lyse has expired 1. Please check if the L-65LEO I lyse is expired first. Please
replace with a barrel of new lyse if it is expired.
L-65LEO II lyse has expired 1. Please check if the L-65LEO II lyse is expired first. Please
replace with a barrel of new lyse if it is expired.
The diluent has expired 1. Please check if the diluent is expired first. Please replace with a
barrel of new diluent if it is expired.
11-46
Troubleshooting
L-65LH lyse has expired 1. Please check if the L-65LH lyse is expired first. Please replace
with a barrel of new lyse if it is expired.
3. If the L-65LH lyse is not expired, please enter the dialogue box
of reagent settings to check if the L-65LH lyse expiry date is
correct.
No diluent 1. Please check if there is any diluent in the diluent barrel first.
No L-65D II lyse 1. Please check if there is any L-65LH lyse in the L-65LH lyse
barrel first.
No L-65LEO I lyse 1. Please check if there is any L-65LEO I lyse in the L-65LEO I
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Troubleshooting
No L-65LEO II lyse 1. Please check if there is any L-65LEO II lyse in the L-65LEO II
lyse barrel first.
Waste are full 1. Please empty the waste barrel or replace with a new waste
barrel.
The right door of the analyser 1. Please close the right door of the analyser.
is open
2. Click One-key Failure Elimination to automatically remove
this failure.
HGB testing exception 1. Please refer to the solution in Chapter 5 Settings - Gain
Settings in Operation Manual to enter the dialogue box of Gain
Settings to adjust HGB background voltage to 4.3 - 4.7 V.
Adjustment to about 4.5V is recommended.
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Troubleshooting
Voltage exception for HGB 1. Please refer to the solution in Chapter 5 Settings - Gain
background Settings in Operation Manual to enter the dialogue box of Gain
Settings to adjust HGB background voltage to 4.3 - 4.7 V.
Adjustment to about 4.5V is recommended.
The background for DIFF 1、 Please check if L-65LEO I or L-65LEO II is polluted first.
scattergram exception
2. Please click One-key Failure Elimination to remove this
failure if it is not polluted.
Appendix A Specification
A.1 Product classification
LW D6500 Classified according to China medical apparatus and instruments management:
It belongs to the blood analysis system among the clinical laboratory analytical instruments
(6840). Its management category is II.
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Troubleshooting
ALY# (research
Abnormal lymphocytes number parameters) 109 / L
Large immature cells number LIC# (research 109 / L
Neutrophils percentage parameters)
Neu% %
Lymphocytes percentage Lym% %
Monocytes percentage Mon% %
Eosinophils percentage Eos% %
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Troubleshooting
A.4.2 Throughput
Whole blood mode ≥60 Tests/h
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Troubleshooting
HCT 0 - 67% ±2% (HCT value) or ±3% ±4% (HCT value) or ±6%
(error percentage) (error percentage)
A.5.4 Reproducibility
Measure the blood sample that satisfies the requirements 11 times continuously with the analyser.
Take the results from 2 to 11 times to determine repeatability.
A.5.5 Carryover
Parameters Carryover
WBC ≤0.5 %
RBC ≤0.5 %
HGB ≤0.5 %
HCT ≤0.5 %
PLT ≤1.0 %
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Troubleshooting
Warnings:
External devices like computer, printer, etc must pass the mandatory
certification of CCC (S&E). Using external devices that do not satisfy the
requirements may cause abnormal running of the system and personal injury.
Note:
1. The external computer must satisfy the configuration requirements in A.6.1.
2. The external computer should be configured to double network cards if the
analyser needs to communicate with laboratory information system.
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Troubleshooting
Note:
Please store and use the analyser only in the specified environmental
conditions.
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Troubleshooting
Heig
ht
De
pth
Widt
h
Analyser of analyser
Width ≤410
(mm)
Height ≤550
(mm)
Depth ≤550
(mm)
Weight ≤42
(Kg)
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Troubleshooting
11-57
of analyser
Accessories Label
identificatio 〇 〇 〇 〇 〇 〇
n
Bottle cap
〇 〇 〇 〇 〇 〇
components
Maintenanc
〇 〇 〇 〇 〇 〇
e tools
Wash block 〇 〇 〇 〇 〇 〇
Packaging Packaging
〇 〇 〇 〇 〇 〇
materials
〇: indicates that the toxic or hazardous substances contained in all homogeneous materials of this
component are below the tolerated requirements of SJ/T 11363-2006.
×: indicates that the toxic or hazardous substances contained in at least one of the homogeneous
materials of this component are above the tolerated requirements of SJ/T 11363-2006.
(1) Some parts on the circuit boards contain lead as leaded solder is used during the machining
process.
(2) Hexavalent chromium is used in the machining process of the surface-coating of sheet metal
parts.