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Operator’s Manual
© 2008-2015 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2015-07.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure
of the information in this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only
if:
all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and
local requirements; and
I
It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or injury of human health.
Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.
II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Mindray or repairs by people other than Mindray authorized personnel.
Malfunction of the instrument or part whose serial number is not legible enough.
III
Company Contact
Tel: 0049-40-2513175
Fax: 0049-40-255726
IV
Table of Contents
2
Table of Contents
3
1 Using This Manual
1.1 Introduction
This chapter explains how to use your BC-5300 operator’s manual, which is shipped with your
BC-5300 AUTO HEMATOLOGY ANALYZER and contains reference information about the
BC-5300 and procedures for operating, troubleshooting and maintaining the analyzer. Read
this manual carefully before operating your analyzer and operate your analyzer strictly as
instructed in this manual.
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Using This Manual
This manual contains information written for clinical laboratory professionals to:
1-2
Using This Manual
This operator’s manual comprises 12 chapters and 3 appendices. Refer to the table below to
find the information you need.
1-3
Using This Manual
This manual uses certain typographical conventions to clarify meaning in the text:
all capital letters enclosed in [ ] indicate a key name on the external keyboard, such as
[ENTER].
bold letters included in “ “ indicate text you can find on the screen, such as “Clean”.
bold letters indicate chapter titles, such as Chapter 1 Using This Manual.
All illustrations in this manual are provided as examples only. They may not necessarily reflect
your analyzer setup or data displayed.
1-4
Using This Manual
All the samples, controls, calibrators, reagents, waste and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them in the laboratory.
If leaking happens to the analyzer, the leak is potentially biohazardous.
Please check the firmness of all the doors, covers and boards before
running the analyzer.
Make sure all the safety measurements are adopted. Do not disable any
safety device or sensor.
Please take action to any alarm and error message immediately.
Do not touch the moving parts.
Contact Mindray or Mindray-authorized distributors immediately if any
damaged part is found.
Be careful when opening/closing and removing/installing the doors, covers
and boards of the analyzer.
Discard the analyzer according to government regulations.
polluted.
It is recommended that the anti-virus software should be installed on the
computer and run regularly.
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Using This Manual
1.6 Symbols
BIOLOGICAL RISK
HIGH VOLTAGE
1-7
Using This Manual
EARTH (GROUND)
ALTERNATING CURRENT
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
MANUFACTURER
TEMPERATURE LIMITATION
IRRITATING SUBSTANCE
1-8
Using This Manual
1-9
Using This Manual
(1)
The sample probe is sharp and potentially biohazardous, please be careful when operating.
1-10
Using This Manual
(1)
To avoid electric shock, disconnect power cord prior to removing or replacing fuse.
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Using This Manual
(1)
To avoid injury, do not put your hands around the guide channel of the syringe board.
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Using This Manual
(1)
To avoid injury, do not put your hands around the guide channel of the syringe board.
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Using This Manual
(1)
Laser radiation when opening, avoid direct eye exposure.
1-14
2 Understanding Your Analyzer
2.1 Introduction
2-1
Understanding Your Analyzer
The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that
require additional studies.
The BC-5300 is a quantitative, automated hematology analyzer and 5-part differential counter
used in clinical laboratories.
It provides the following 23 basic parameters, 4 parameters for research use, 3 histograms
and 1 scattergram of blood samples. It supports 2 measurement modes: CBC and CBC+DIFF.
2-2
Understanding Your Analyzer
Hematocrit HCT * *
Platelet count PLT * *
Mean Platelet Volume MPV * *
Platelet Distribution Width PDW * *
Plateletcrit PCT * *
White Blood Cell/Basophils Histogram WBC/BASO / *
Histogram
White Blood Cell Histogram WBC Histogram * /
Red Blood Cell Histogram RBC Histogram * *
Platelet Histogram PLT Histogram * *
Differential Scattergram Diff Scattergram / *
“*” means the parameter is provided in the mode. “/” means the parameter
is not provided.
ALY%, LIC%, ALY# and LIC# are parameters for research use only, not for
diagnostic use. For more details about the RUOs, please see 5.3.1 General
(Settings) Research use only parameter (RUO parameter).
2-3
Understanding Your Analyzer
Please check the firmness of all the doors, covers and boards before
running the analyzer.
The analyzer is heavy, to move it by one person may cause injury. It is
advisable for two people move it together when transport is needed, and
make sure you follow the instructions and use the proper tools.
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Understanding Your Analyzer
2-5
Understanding Your Analyzer
2-6
Understanding Your Analyzer
2-7
Understanding Your Analyzer
2-8
Understanding Your Analyzer
To avoid damage, do not turn on/off the power of the analyzer continually in
a short time.
2-9
Understanding Your Analyzer
The interface can be divided into several areas as follows according to their functions:
2-10
Understanding Your Analyzer
It displays the information about the sample ID, analysis mode (whole blood/prediluted blood)
and measurement mode (CBC/CBC+DIFF) of the next sample.
4. Status area
The area is on the top right of the screen. There are three items from left to right, namely:
LIS/HIS status:
Print status:
5. Minimize button
You can click the button to minimize the interface to the taskbar of the operation system.
You can click the interface icon displayed on the taskbar to re-display the
interface after minimizing it.
7. System time
It displays the time of the operation system. When you move the mouse to this area, the tips
will pop up to display the current system time. See Chapter 5 Customizing the Analyzer
Software for ways to modify the time format.
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Understanding Your Analyzer
input mode button to open the input languages menu, and then you can switch to the desired
input language by clicking on the menu.
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Understanding Your Analyzer
Click the “Error Message Area” Alt + F1 Open the “Troubleshooting” message box
2-13
Understanding Your Analyzer
2.6.2 Click
Move the pointer to the desired content; left click the mouse then release.
Repeat the operation if you failed to select the content and check the
connection of the mouse if necessary. If the problem still exists, please
contact Mindray customer service department or your local distributor
immediately.
Repeat the operation if you failed to select the content and check the
connection of the mouse if necessary. If the problem still exists, please
contact Mindray customer service department or your local distributor
immediately.
Repeat the operation if you failed to select the content and check the
connection of the mouse if necessary. If the problem still exists, please
contact Mindray customer service department or your local distributor
immediately.
2-14
Understanding Your Analyzer
Move the pointer to the slide bar, left click the mouse and hold, then drag the bar at will.
2.6.7 Tab
Tab displays one page of the multipage information. E.g. you can enter the “Settings” tab of
the “L-J” screen to view and set up the information. The “Settings” tab is shown below.
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Understanding Your Analyzer
2.6.8 Buttons
Common buttons
The system will perform the function after you clicking the certain button. E.g. the system will
print after you clicking the “Print” button as shown below.
Click the button to display the pull-down list as shown below. The options will be displayed in
the pull-down list.
When a combo list is open, you can select the desired item in the list by using the [↑] and
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Understanding Your Analyzer
When a combo list is open, you can hide it by pressing the [Enter] key on the keyboard or
selecting a certain option. Then, the original content in the combo box will be replaced by
the current selected one.
When a combo list is open, you can hide it by pressing the [Esc] key on the keyboard
without changing the original content.
The scroll bar will appear if the content of the list can not be fully displayed
in one screen. You can drag the scroll bar or use the [PgUp] and [PgDn]
keys on the keyboard to view the content fully.
After clicking the arrow button on the date control, a date selection box will pop up.
Select the year: click the displayed year, then the arrow buttons will appear on its right
side, and then click the arrow button to select the desired year.
Method 1: click the arrow buttons on the both sides of the date box to switch to the desired
month.
Method 2: click the current displayed month, then click the desired month from the list
appeared as shown below.
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Understanding Your Analyzer
Select the day: click the desired day, then the date box will hide. The selected date
(including year, month and day) will replace the original date.
When the date selection box popping up, you can hide it by pressing the [Esc] on the
keyboard without changing the date.
Radio button
Click the radio button in the circle to select the option. E.g. the following figure shows that the
“Auto Increace” is selected whereas the “Manual Entry” is not selected.
Click the “Switch between different information fields by [Enter] key” again, the “√”
disappeared, it means the option is not selected as shown below:
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Understanding Your Analyzer
More than one check box can be selected at the same time for one setting
option.
You can also proceed to the following operations in the edit box:
Move the cursor to the left or right by using the [←] and [→] key on the keyboard.
Move the cursor to the left of the initial character or the right or the end character by
pressing the [Home] and [End] key on the keyboard.
Delete the character on the right of the cursor by using the [Delete] key on the keyboard.
Delete the character on the left of the cursor by using the [Backspace] key on the
keyboard.
Switch to another edit box by using the [Tab] key on the keyboard.
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Understanding Your Analyzer
The scroll bar (horizontal/vertical) will appear if the content of the edit box
can not be displayed in one screen. You can drag the scroll bar or use the
[PgUp] and [PgDn] keys on the keyboard to view the content fully.
See Arrow button of the combo box section for details to complete selecting. See Edit Box
section for details to complete editing if the combo box is editable.
2.6.13 Form
The form contains several cells and check box (sometimes).
Click the certain cell to select it:
2-20
Understanding Your Analyzer
Select the cell by using the [↑] and [↓] and [←] and [→] keys on the keyboard.
Select the initial or end cell of the current row by using the [Home] and [End] keys on the
keyboard.
Select the next cell of the current line by using the [Enter] key on the keyboard.
Select the next cell of the current row by using the [Tab] key on the keyboard (can not
switch to a new row).
Move the mouse to the boundary line between rows or lines, and then left click the mouse
and hold, drawing the boundary line to change the height/width of the row/list, but the
height/width of the whole form remains.
For an editable cell, a cursor will appear in the cell if it is double clicked. You can enter the
characters from the location of the cursor and the cursor moves to the right at the time. An
edited form is shown below:
Move the cursor to the left or right in the cell by using the [←] and [→] keys on the
keyboard.
Move the cursor to the left of the initial character or the right or the end character by
pressing the [Home] and [End] key on the keyboard.
Delete the character on the right of the cursor by using the [Delete] key on the keyboard.
Delete the character on the left of the cursor by using the [Backspace] key on the
keyboard.
Hide the cursor and quit editing by using the [Enter] key on the keyboard.
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Understanding Your Analyzer
If a check box exists in the form, see the previous “check box” section for
details to operate. The selected check boxes in the forms will not be cleared
when you switching among the screens unless you exit the software.
If a check box exists in the form, then when you click the check box, it will
be ticked and the record will also be highlighted.
If you wish to select several continuous records in a form, click the initial
record and a “√” mark appears, then click the desired ending record while
pressing and holding the [Shift] key on the keyboard, then a set of records
are selected conveniently.
If you wish to select several consecutive records, click the first record and
then hold and drag the mouse to the last one, and then release the mouse to
select them all.
The scroll bar (horizontal/vertical) will appear if the content of the edit box
can not be displayed in one screen. You can drag the scroll bar or use the
[PgUp] and [PgDn] keys on the keyboard to view the content fully.
Method 1: click the first-level menu option to open its submenu, and then click the desired
option on the submenu.
Method 2: first, move to the submenu option on the first-level menu by using the [↑] and [↓]
keys on the keyboard and open the submenu by pressing the [→]or [Enter] key, then move to
the desired option by the [↑] and [↓] keys, at last press the [Enter] key to open the screen.
2-22
Understanding Your Analyzer
A “+”mark indicates the followed menu option has a submenu. Click the menu option, its
submenu will fully display and the “+” mark changes to “-”mark; click the menu option
again, its submenu will hide and “-” changes to “+” again as shown below:
The menu option without “+” or “-” mark has no submenu. Click the menu option, the
information will display directly.
Use the [↑] and [↓] keys on the keyboard to move the highlight bar to the desired menu
option.
Use the [Home] and [End] keys on the keyboard to move the highlight bar to the initial or
ending option.
Use the [Enter] key on the keyboard to display the submenu of a menu option. If the menu
option has no submenu, the relative information will display directly.
If the submenu of a menu option has displayed, you can hide it by using the [Enter] key on
2-23
Understanding Your Analyzer
the keyboard.
The scroll bar (horizontal/vertical) will appear if the content of the edit box
can not be displayed in one screen. You can drag the scroll bar or use the
[PgUp] and [PgDn] keys on the keyboard to view the content fully.
After selecting the data you want to delete, click the “OK” button to close the message
box and complete the deletion; click the “Cancel” button to close the message box
without deleting the data.
Click the button on the right side of the title area to close the message box without
deleting the data.
The “2/79” in the above figure indicates the total number of the records is 79, and the current
record is the second one.
If you wish to switch to the previous or the next record, click or button.
If you wish to switch to the first or the last record, click or button.
Click the edit box of the record switch column, enter the desired number of the record,
and then switch to the relative screen by using the [Enter] key on the keyboard.
2-24
Understanding Your Analyzer
The message box displays the help information of the current screen and the corresponding
menu (highlighted).
If you wish to browse other help information, click the desired menu option then the help
information will display on the right.
Click the button on the top right corner to close the message box.
2-25
Understanding Your Analyzer
Then, click the “Search” tab to enter the key words into the search information box.
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Understanding Your Analyzer
After entering the key words, click the “List Topics” button or press the [Enter] key on the
keyboard to start searching.
You can stop searching by clicking the “Stop” button. Then, the obtained
result displays.
When the search is finished, all the related menu items will be displayed in the left corner and
the corresponding help information will be displayed at the right side screen.
You can click the menu item to check the corresponding help information.
2.7.3 Print
You can click the “Print” button to print the current displayed help information.
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Understanding Your Analyzer
Because the analyzer, reagents (diluent, rinse, lyses and probe cleanser), controls, and
calibrators are components of a system, performance of the system depends on the combined
integrity of all components. You should only use the Mindray-specified reagents (see
Appendix B Specifications), which are formulated specifically for the fluidic system of your
analyzer in order to provide optimal system performance. Do not use the analyzer with
reagents from multiple suppliers. In such use, the analyzer may not meet the performance
specified in this manual and may provide unreliable results. All references related to reagents
in this manual refer to the reagents specifically formulated for this analyzer.
Each reagent package must be examined before use. Inspect the package for signs of leakage
or moisture. Product integrity may be compromised in packages that have been damaged. If
there is evidence of leakage or improper handling, do not use the reagent.
Store and use the reagents as instructed by instructions for use of the
reagents.
When you have changed the diluent or lyses, run a background to see if the
results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
After installing a new container of reagent, keep it still for a while before
use.
2.8.1 Reagents
M-53D Diluent
It provides a stable environment for counting and sizing blood cells.
M-53LH Lyse
It breaks down red blood cell walls and converts hemoglobin to a hemoglobin complex to
determine the HGB. It 2-differentiates WBCs to Basophils and other WBCs, and determines
WBC amount.
2-28
Understanding Your Analyzer
2-29
3 Understanding the System
Principles
3.1 Introduction
The measurement methods used in this analyzer are: the Electrical Impedance method for
determining the WBC/BAS, RBC and PLT data; the colorimetric method for determining the
HGB; flow cytometry by laser for determining the WBC data. During each analysis cycle, the
sample is aspirated, diluted and mixed before the determination for each parameter is
performed.
3-1
Understanding the System Principles
3.2 Aspiration
The analyzer supports two types of blood samples – whole blood samples and prediluted
blood samples.
If you are to analyze a whole blood sample, the analyzer will aspirate 20μL (CBC+DIFF mode)
or 15μL (CBC mode) of the sample.
If you are to analyze a capillary blood sample, you should first manually dilute the sample
(20μL of capillary sample needs to be diluted by 180μL of diluent) and then present the
pre-diluted sample to the analyzer, which will aspirate 80μL(CBC+DIFF) or 40μL(CBC) of the
sample.
3-2
Understanding the System Principles
3.3 Dilution
Then, the sample will be divided into 2 portions and be diluted and processed by different
reagents. After this, they are ready for analysis.
This analyzer can process two types of blood samples – whole blood samples and prediluted
blood samples.
2.5 mL diluent
3.5mL
52.08μL
About 1:417.6 dilution
3-3
Understanding the System Principles
20 μL capillary blood
180 μL diluent
40μL
2.46 mL diluent
60μL
About 1:625 dilution
20 μL capillary blood
sample
180 μL diluent
40μL
1.1 mL M-53LEO(I) lyse
000111111.994ml
3-4
Understanding the System Principles
After a predetermined volume of blood is aspirated and diluted by a certain amount of reagent,
it is injected into the flow cell. Surrounded with sheath fluid (diluent), the blood cells pass
through the center of the flow cell in a single column at a faster speed. When the blood cells
suspended in the diluent pass through the flow cell, they are exposed to a laser beam. The
intensity of scatter light reflects the blood cell size and intracellular density. The low-angle
scattered light reflects cell size, and the high-angle scattered light reflects intracellular density
(nucleus size and density). The optical detector receives this scatter light and converts it into
electrical pulses. Pulse data collected can be used to draw a 2-dimensional distribution
(scattergram). As shown in Figure 3-2 , X-axis represents the intracellular density and Y-axis
the blood cell size. Various types of analysis data can then be obtained from the scattergrams.
3-5
Understanding the System Principles
By analyzing the DIFF channel scattergram, the analyzer presents the Lym%, Mon%, Eos%
and Neu%.
Each pulse is amplified and compared to the internal reference voltage channel, which only
accepts the pulses of a certain amplitude. If the pulse generated is above the WBC/BAS lower
threshold, it is counted as a WBC/BAS. The analyzer presents the WBC/BAS histogram,
whose x-coordinate represents the cell volume(fL) and y-coordinate represents the number of
the cells.
3-6
Understanding the System Principles
achieved the WBC, the analyzer proceeds to calculate Lym#, Neu#, Mon# and Eos# per the
following equations while Bas# is obtained directly by the Electrical Impedance method and
9
express them in 10 /L.
WBC is the number of leukocytes measured directly by counting the leukocytes passing
through the aperture.
Basophils number
Bas# is the number of Basophils measured directly by counting the Basophils passing
through the aperture.
Basophils percentage
Bas#
Bas% 100%
WBC
Lymphocytes percentage
Neutrophils percentage
Monocytes percentage
Eosinophils percentage
Neutrophils number
Monocytes number
Eosinophils number
3-8
Understanding the System Principles
3.5.2 HGB
The HGB is calculated per the following equation and expressed in g/L.
Blank Photocurrent
HGB(g/L) Constant Ln
Sample Photocurrent
3-9
Understanding the System Principles
Each pulse is amplified and compared to the internal reference voltage channel, which only
accepts the pulses of a certain amplitude. If the pulse generated is above the RBC/PLT lower
threshold, it is counted as a RBC/PLT. The analyzer presents the RBC/PLT histogram, whose
x-coordinate represents the cell volume(fL)and y-coordinate represents the number of the
cells.
3.6.2 RBC
RBC
12
RBC (10 /L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.
3-10
Understanding the System Principles
Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
expresses the result in fL.
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows, where the RBC is
12
expressed in 10 /L, MCV in fL and HGB in g/L.
RBC MCV
HCT
10
HGB
MCH
RBC
HGB
MCHC 100
HCT
Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation, %) of
the erythrocyte distribution width.
RDW-SD (RBC Distribution Width – Standard Deviation, fL) is obtained by calculating the
standard deviation of the red blood cell size distribution.
3.6.3 PLT
Platelet count
9
PLT (10 /L) is measured directly by counting the platelets passing through the aperture.
Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).
Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet size
distribution. Each PDW result is derived from the platelet histogram data and is reported as
10(GSD).
PCT
This analyzer calculates the PCT as follows and express it in %, where the PLT is expressed
3-11
Understanding the System Principles
9
in 10 /L and the MPV in fL.
PLT MPV
PCT
10000
3-12
Understanding the System Principles
3.7 Wash
After each analysis cycle, each element of the analyzer is washed.
3-13
4 Installing Your Analyzer
4.1 Introduction
Your analyzer is tested before it is shipped from the factory. International symbols and special
handling instructions tell the carrier how to treat this electronic instrument. When you receive
your analyzer, carefully inspect the carton. If you see any signs of mishandling or damage,
contact Mindray customer service department or your local distributor immediately.
4-1
Installing Your Analyzer
at least 100 cm on each side, which is the preferred access to perform service
procedures.
enough room on and below the countertop to accommodate the diluent and waste
containers.
The supporting table where the analyzer is placed shall be able to withstand at least 60kg
of weight.
Using plug-board may bring the electrical interference and the analysis
results may be unreliable. Please place the analyzer near the electrical outlet
to avoid using the plug-board.
Please use the original electrical wire shipped with the analyzer. Using other
electrical wire may damage the analyzer or cause unreliable analysis
results.
NOTE
Main supply voltage fluctuations up to ±10% of the nominal voltage.
4-2
Installing Your Analyzer
The environment should be as free as possible from dust, mechanical vibrations, loud
noises, pollution and electrical interference.
Do not use this analyzer in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
Do not place the analyzer in direct sunlight or in front of a source of heat or drafts.
4-3
Installing Your Analyzer
Please make sure the length of the diluent pipe and the waste pipe is not
longer than 1500mm; the length of the lyse pipe is not longer than 850mm.
4-4
5 Customizing the Analyzer Software
5.1 Introduction
The BC-5300 is a flexible laboratory instrument that can be tailed to your work environment.
You can use the “Setup” program to customize the software options as introduced in this
chapter.
The analyzer divides the operators into two levels, common user and administrator. Note that
an administrator can access all the functions open to a common user. This chanter introduces
how to customize your analyzer respectively as a common user level and as an administrator.
5-1
Customizing the Analyzer Software
Date format
Date format can be set at this screen. Note that when the date format setting is changed, all
the displayed and printed date format will be affected, including the draw date, delivery date,
run date, entry date of the work list, reagent expiration date, quality control date, calibration
date, and etc.
At the “General Setup” screen, click the “Date Format” button to enter the setup screen.
5-2
Customizing the Analyzer Software
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save all the settings and close the setup screen
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
5-3
Customizing the Analyzer Software
Reagents
Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.
You can set the expiration date of the diluent, LEO (I) lyse, LEO (II) lyse and LH lyse at the
“Reagent” screen.
At the “General Setup” screen, click the “Reagent” button to enter the reagent setup screen.
If you wish to set the expiration date for the reagents, you can click the check box “Exp. Date”
to select it. This option is selected as default.
If the “Exp. Date” check box is not selected, then the “Reagent Expired” will
not be alarmed.
5-4
Customizing the Analyzer Software
After selecting the check box of “Exp. Date”, you can click the arrow button of the edit box to
set the expiration date of each reagent by using the date control.
The range of the expiration date is from the current system date to
2099-12-31.
You can not edit the open-container expiration date for it is calculated
automatically by the software and displayed in the form of text.
If the current system date exceeds the displayed expiration date or the
open-container expiration date whichever is earlier, then the “Reagent
Expired” will be alarmed.
When the reagent is expired, you can check the expiration date and the
open-container expiration date here to determine which one led to the
expiration alarm.
When the reagent is expired, you can not run any samples.
If an external barcode scanner is connected, you can click the “Use barcode scanner” check
box to enable it. Scan the barcode with the external barcode scanner. If the scan is successful,
the expiration date of the reagent will be displayed in the corresponding box.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
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Auxiliary
At the “General Setup” screen, click the “Auxiliary” button to enter the auxiliary screen.
If you have activated the reminder and selected the predilute mode, a message box will pop up
to ask for confirmation every time you try to analyze a sample in the predilute mode.
To activate the reminder, click the “Ask for confirmation” radio button (default). To deactivate
the reminder, click the “Do not ask for confirmation” radio button.
Select “Auto Increase” (default) so that the sample ID can increase automatically; select
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“Manual entry (by keyboard or bar scanner)” if you want to enter the sample ID manually.
Even in the “Auto increase” mode, you can still change the sample ID by
re-entering the desired number through keyboard or the bar-code scanner.
The new setting of the prefix will only be applied to the later sample IDs. It
will not affect the IDs run previously and those already entered in the
worklist.
If the prefix is entered, and the sample ID entry method is set as “Auto
Increase”, then a revisable prefix will be displayed automatically in the
sample ID box every time when you entering/editing the information.
If the sample ID entry method is set as “Manual entry (by barcode scanner
or keyboard)”, then no matter the prefix is set or not, the default sample ID
of a new record in the worklist will be empty.
Other settings
If you want to add a new record automatically after the previous one is entered and saved in
the worklist, you can select “Save and jump to next record”.
If you wish to jump to the next record once the current one is validated, you can select the
check box “Validate and jump to next record”. This option is selected as default.
If you wish to switch between different information fields by [Enter] key, you can select the
check box “Switch between different information fields by [Enter] key”. The default setting
of this option is selected and also support switch by [Tab] key. Click the “Information fields”
button next to the option and the following message box will pop up.
There is a check box in front of each information field; the default setting is all selected. It
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means information entry of all demographics is requested. You can click a check box or some
boxes to cancel the selected mark “√”. It means you can jump over the unselected
demographics by pressing [Enter] or [Tab] key, leaving them in blank. However, you can also
re-locate the cursor in the information field by the mouse to re-enter the information.
Click “Ok” to save the entered information and close the message box, then back to the
“Auxiliary” screen.
If you wish to delete the completed record from the worklist after each run, you can click the
check box “Automatically delete completed records from the worklist.” selecting it by a
“√”in the box. The default setting of this option is not selected.
If you wish to apply the current system date to the “Draw Time” and “Delivery Time” for new
added sample records, you can select the check box “Automatically generate the draw date
and delivery date”. The default setting of this option is not selected.
Any change made to the option “Automatically generate draw the date and
delivery date” will only be applied to later added sample records. Records
entered previously in the worklist will not be affected.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
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When you log in as a common user, click the “Menu” button, and then select the “Setup”, then
select “User and Password” from the pop up menu to enter the information list of all the
administrators and common users.
Change password
1. Highlight the current login user in the list, and then click the “Change password” button,
the following message box will pop up.
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2. Enter the current login password in the edit box “Old password”, and then enter the new
password in the “New password” and “Confirm password” box.
3. Finish entering; click “Ok”, then a message box will pop up.
4. Click “OK” to close the message box and back to the previous screen.
Click the “Close” button to exit the “User and Password” screen.
Lab Information
When you log in as a user of common level, click the “Menu” button, and then select the
“Setup”, and then select “Lab Info.” from the pop-up menu, and then the lab information box
will pop up. You can only browse the information.
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Exit
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You can click the “Department”, “Deliverer”, “Diagnosis” and “Gender” button to check the
corresponding shortcut code.
Exit
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5.3 Administrator
Auxiliary
At the “General Setup” screen, click the “Auxiliary” button to enter the auxiliary screen.
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Authority setup
To allow common users to edit the ID of the sample run already in the review screen, you can
select the check box “Edit ID of sample run already”. The default setting of this option is not
selected.
If you wish to enable users of common level the authority of editing/restoring the sample result,
you can select the check box “Edit sample result”. This option is not selected as default.
If you wish to enable the users of common level the authority of validating the sample result,
you can click the check box “Validate sample”. This option is not selected as default.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
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Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
Para. Units
Some references/parameters used by the analyzer could in several different units; you can
select the desired unit.
At the “General Setup” screen, click the “Para. Units” button to enter the screen.
Parameters of the same group are displayed together, with the first parameter in black and the
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rest in gray.
Unit standard
Click the check box “Select unit system” to select the desired unit standard form the following
seven ones: Customized, China, International (default), USA, Canada, Netherlands and
Britain.
When selecting different unit standards, the corresponding unit list and unit
option will display accordingly.
If “Customized” is selected, then you can modify the unit of each parameter.
If other option is selected except the “Customized”, then the unit of each
parameter can only be browsed.
When “Customized” is selected, click the desired parameter, and then click the unit options
provided on the right to select a new unit for the parameter.
For parameters in a same group, if the unit of any parameter changes, the
units of the rest parameters change accordingly.
The unit of MCH changes according to MCHC and HGB, the operator can not
modify it.
If the parameters units change, the format of the data displayed in the list
will change accordingly.
Default
When “Customized” is selected, click the “Default” button to have the default units
(International) of all parameters displayed in the corresponding cell.
Click the “Print” button to print all the parameters’ units in the current screen.
If you haven’t saved the settings when clicking the “Print” button, a message box will pop up.
Click “Yes” to save the new settings and print them; click “No” to print the content of the
original settings without saving.
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Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
Ref. Range
The “Ref. Range” screen is where you view and set the upper and lower limits for your patients.
The analyzer flags any parameter value above (H) or below (L) these limits.
This analyzer divides patients into 5 demographic groups: General, Man, Woman, Child and
Neonate. You can also customize another 5 groups. The default setting is “General”. The
recommended limits are provided for your reference only. To avoid misleading parameter flags,
be sure to set the patient limits according to the characteristics of your local population.
At the “General Setup” screen, click the “Ref. Range” button to enter the screen.
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Click the “Set ref. group” button, a message box will pop up.
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You can not modify the names and corresponding information of the five
fixed reference groups in the list.
You can modify the names, age range (including age value and unit) and
gender of the five customized reference groups.
Double click the “Ref. Group” cell of the five customized reference group to modify the name
of the group.
Double click the age cell of the customized reference group to modify the age; double click the
age unit cell to open a combo box with different age units for you to choose from: Year, Month,
Day, and Hour.
Double click the “Gender” cell of the customized reference group to open a combo box with
different options for you to choose from: Not defined, Male, Female, Empty.
Click the check box of “Automatically match the customized ref. group according to age
and gender” to select it. The option is not selected as default.
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Click one of the reference groups to highlight it, and then click the “Set to be default ref.
group” button to set this group as the default group when entering the worklist.
Click one of the reference groups to highlight it, and then click the “Default” button to display
the default information including group title, age limit, age unit and gender in the corresponding
cell.
Click the “Print” button to print out the settings in accordance with the age and gender of the
reference group. If the previous settings are not saved when you click the “Print” button, a
message box will pop up.
Click “Yes” to save the new settings and print them; click “No” to print the content of the
original settings without saving.
Click the “Ok” button to save and refresh the settings and close the “Set ref. group” message
box.
1. Click the “Ref. Group” combo box, then select the desired group from the options:
General, Man, Woman, Child, Neonate and Customized 1-5.
2. Drag scroll bar; then click the “Upper limit” or “Lower limit” cell of the parameter you
want to setup.
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Default
Click the “Default” button to display the default reference range of the current reference group
in the corresponding form.
Click the “Print” button to print the reference ranges of all reference groups.
If the previous settings are not saved when you click the “Print” button, a message box will pop
up.
Click “Yes” to save the new settings and print them; click “No” to print the content of the
original settings without saving.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
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You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
At the “General Setup” screen, click the “Print” button to enter the screen.
Enter the print title in the “Title” box. The default title is “Hematology Analysis Report”.
Click the “Paper type” box to select the desired paper type from the five types: A5 (default), A4,
continuous paper, B6 and B5.
If you want multiple copies of the same patient report to be printed, you can enter the desired
number (1 - 100) into the “Copies” field. The default number is 1.
Click the “Format” combo box to display the report format options for you to select from. The
report format in the combo box differs according to the selected paper type. The default
formats for different papery types are shown in the following list:
Print Preview
After editing the print setup, you should preview the report before printing
to make sure the setup is correct.
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You can click the “Customize” button to enter the “PrintTemplate” screen, and then customize
the print template. See Chapter 12 Customizing the Print Template for details of how to
customize.
Autoprint
The analyzer can auto-print the report in the set format once the analysis result is obtained.
Click “On” to enable the autoprint function; click “Off” to disable the autoprint function. The
default setting is “Off”.
If “Autoprint” is “On”, then the “Autoprint after validation” check box will be activated.
Select the “Autoprint after validation” to autoprint the report only after the sample is
validated; otherwise, the report will be printed once the running is finished.
Print Flag
If the flag information is needed in the printed report, you should select the “Print Flag” check
box .The default setting of this option is not selected.
If the default report template that you selected displays the flag information,
then the “Print Flag” check box here will be available for you to select.
If the default report template that you selected doesn’t display the flag
information, or the selected template is a customized one, then the “Print
Flag” check box here will be unavailable for you to select.
If the suspect flags “?” are needed in the printed report, you should select the “Print suspect
flags “?”” check box. This option is selected as default.
If the reference range is needed in the printed report, you should select the “Print ref. range”
check box. This option is selected as default.
If the ref. range flags (“H” or “L”) are needed in the printed report, you should select the “Print
ref. range flags” check box. This option is selected as default.
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If “Print ref. range” is selected, then the “Print ref. range flags” option will
also be enabled and unavailable for you to edit. The ref. range and the ref.
range flags (“H” or “L”) will be printed in the report together.
If you want to de-select the “Print ref. range flags” option when “Print ref.
range” is selected (print the ref. range in the report only), please contact
Mindray customer service department or your local distributor.
If “Print ref. range” is not selected, then you can select whether to print the
ref. range flags (“H” or “L”) in the report at will.
If the result edited flags (“E” or “e”) are needed in the printed report, you should select the
“Print result edited flags” check box. This option is selected as default. For details of how to
edit result, please see Edit Result section in 7.2.3 or 7.3.3 Function of the Buttons
If the ambient temp. abnormal flags (“T”) are needed in the printed report, you should select
the “Print ambient temp. abnormal flags” check box. This option is selected as default.
If the test date of each QC point needs to be printed out when printing QC graphs, you can
select the “Print QC graph time” check box.
Click the “Default printer” check box to display the printers available to the current system,
and then you can select one type from them as the default printer to perform all the print tasks.
If you change the default printer here, then the default printer of the current
operation system will also change.
If you change the default printer in the operation system, then the printer
name in this check box will also change.
Apply
Click the “Apply” button, save all the settings without closing the setting window.
Ok
Click the “Ok” button, save all the settings and close the setting window.
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Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
Communication
At the “General Setup” screen, click the “Communication” button to enter the
“Communication” screen.
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The settings here are applied to the communication between the analyzer
and the external (i.e. LIS), but not between the analyzer and the terminal
software.
Setting IP address
Enter the IP address into the empty (default) “IP address” box.
Setting Port
Enter the port number into the empty (default) “Port” box.
Auto-communication
The function is used for automatically transmitting the sample result to the external data
management software or LIS/HIS system.
Click “On” to enable the auto-communication; click “Off” to disable the auto-communication.
The default setting is “Off”.
The function is used for automatically obtaining the sample/patient information from the
LIS/HIS system after the sample ID is entered or scanned, and automatically transmitting the
sample result to the LIS/HIS system.
Click “On” to enable the bidirectional LIS/HIS communication; click “Off” to disable it. The
default setting is “Off”.
Communication Acknowledgement
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Select “On”: when IPU software is communicating with LIS/HIS, the HL7 protocol must be
strictly followed. After receiving the ACK acknowledgement from LIS/HIS, the communication
can be deemed successful; otherwise the communication fails, a communication failure notice
will pop up.
Select “Off”: when IPU software is communicating with LIS/HIS, even if no ACK
acknowledgement from LIS/HIS is received, the communication can be deemed successful; no
failure notice will pop up. Communication flag “T” is recorded in the communication column in
Table Review screen.
Version
The version of the communication protocol, where 2 versions are available for selection (1.0
and 1.1), and the default version is 1.0.
Version 1.1 provides the transmission of flag messages including “WBC Abn.”, “DIFF Channel
Abnormal”, “RBC System Abnormal”, “Aspiration Abnormal”, “System Abnormal” and “RBC
clump?”.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save all the settings and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
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The RUO parameters are for research use only, not for diagnostic use.
At the “General Setup” screen, click the “RUO” button to enter the “RUO” screen.
Setting display
If you wish to display the RUO parameters, select the “Display RUO parameters” check box.
This option is selected as default.
If “Display RUO parameters” is selected and you also wish to display the “*” mark, you can
select the “Display “*” mark” check box. This option is selected as default.
If “Display RUO parameters” and “Display “*” mark” are selected and you also wish to
display declaration (“*” means “research use only, not for diagnostic use”), you can select the
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Setting print
If you wish to print the RUO parameters, you can select the “Print RUO parameters” check
box. This option is selected as default.
If “Print RUO parameters” is selected and you also wish to print the “*” mark, you can select
the “Print “*” mark” check box. This option is selected as default.
If “Print RUO parameters” and “Print “*” mark” are selected and you also wish to print
declaration (“*” means “research use only, not for diagnostic use”), you can select the “Print
declaration” check box. This option is selected as default.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save all the settings and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
Gain
You can adjust each digital pot at the “Gain” screen. It is not recommended to adjust gains
frequently.
At the “General Setup” screen, click the “Gain” button to enter the “Gain” screen.
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Click the current value of the “RBC” and then enter the new value.
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You can adjust the HGB blank voltage by adjusting the HGB gain.
You can enter the value directly in the edit box or click the adjusting button to adjust the HGB
gain.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
Auto Maintenance
At the “General Setup” screen, click the “Auto Maintenance” button to enter the screen
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You can set here when to start the auto-maintain procedure after the relevant fluidic operation
stops. Enter the desired time ranging from 15 to 120 minutes into the “Wait” box.
You can enter the desired time in the “Preset time” or click the adjusting button to set the
preset time for time-based maintenance ranging from [0:00(default) – 23:59].
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
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You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
Microscopic Para.
You can set the microscopic parameters for the display of the "Microscopic Exam. And
Others" tab at the "Review" screen and the printout template for reports.
At the “General Setup” screen, click the “Microscopic Para.” button to enter the
“Microscopic Para.” screen.
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2. Enter the name of the new microscopic parameter in the edit box.
3. Click “Ok” to save the information of the new parameter, refresh the para. list without
closing the message box, and the parameter name entered in the message box will be
cleared, and then you can continue to add another new microscopic parameter.
New parameter names can be neither empty nor same as existing ones.
1. Click the desired parameter, and then click the “Edit” button. A message box will pop up.
2. You can enter a new name for the microscopic parameter in the edit box.
3. Click “Ok” button to save the modified parameter name and close the message box, and
then the edited parameter will be highlighted in the list.
Modified parameter names can be neither empty nor same as existing ones.
1. Click the desired cell, and then click the “Delete” button. A message box will pop up.
2. Click “Ok” to delete the microscopic parameter and close the message box, and then the
parameter will be deleted from the list.
1. Click the “Adjust Order” button and a message box will pop up, displaying the current
order of the microscopic parameters in the para. list.
The buttons ("Top", "Up", "Down" and "Bottom") to the right of the list are
used to adjust the order of the microscopic parameters.
2. Click on a microscopic parameter to highlight it. Adjust the position of this parameter using
the buttons on the right.
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Click the "Top" button to move the highlighted microscopic parameter to the top of the list.
Click the "Up" button to move the highlighted microscopic parameter upward by one
position.
Click the "Down" button to move the highlighted microscopic parameter downward by one
position.
Click the "Bottom" button to move the highlighted microscopic parameter to the bottom of
the list.
3. Click the “Ok” button to save the adjusted order, close the message box and go back to
the setup screen. Then the order of parameters will be refreshed.
Ok
Click the “Ok” button to save all the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the “Apply” or “Ok” button.
Flag
The administrator can edit a list of flagging rules at the “Flag Rules” screen
At the “General Setup” screen, click the “Flag Rules”button to enter the “Flag Rules”screen.
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1. Click to select “Leucocytosis” from the flag rules table to display the name and rule.
2. Click the “Edit” button to the right of the rule table, and a dialog box below will pop up.
3. Enter the desired value in the text box and click “Ok”, and then click the “Apply” button
to save the change, or just click “Ok” to save the change and exit the “Flag Rules”
screen.
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The flag rule entered should be within the display range; otherwise, a dialog box
will prompt “Invalid entry.”
Two digits are allowed after the decimal point for the entered value.
4. Click the “Default” button to the right of the rule table to restore the default rules, and
then click “Apply” to save the change, or just click “Ok” to save the change and exit
the setting.
When you log in as an administrator, click the “Menu” button, and then select the “Setup”, then
select “User and Password” from the pop up menu to enter the information list of all the
administrators and common users.
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2. Enter the information in each edit box, and then click the authority combo box to select the
new user as “Common User” or “Administrator”.
3. Click “Ok” to save the information of the new user, refresh the user list without closing the
message box, and all the information fields in the message box will be cleared, and then
you can continue to add another new user.
New user names can be neither empty nor same as existing ones.
You can take the following steps to edit the information of the users:
1. Click the desired cell, then click the “Edit” button, then a message box will pop up.
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2. You can change the content of each item in the edit box or change the users’ level by
clicking the authority combo box.
3. Click the “Ok” button to save the modified users’ information and close the message box,
then the edited record will be highlighted in the users list.
Modified user names can be neither empty nor same as existing ones.
If the current login administrator changes the user level into “common
user”, the settings take effect only after logout and then re-login.
Deleting a user
1. Click the desired cell, and then click the “Delete” button; a message box will pop up.
2. Click “Ok” to delete the user and close the message box, then the user will be deleted from
the users list.
Reset password
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You can reset a new password for users who forgot the password:
1. Click the desired cell, and then click the “Reset password” button, a message box will pop
up.
2. Enter the new password in the “New password” and “Confirm password” box.
3. Click “Ok” button to save the new password and close the message box.
You can not reset the password for the current login user.
Change password
1. Highlight the current login user in the list, and then click the “Change password” button,
the following message box will pop up.
2. Enter the current login password in the edit box “Old password”, and then enter the new
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4. Click “OK” to close the message box and back to the previous screen.
Click the “Close” button to exit the message box of “User and Password”.
Lab Information
When you login as a user of administrator level, click the “Menu” button, and then select
“Setup”, and then select “Lab Info.” from the pop-up menu, and then the lab information box
will pop up. All the information fields in the box are activated for you to enter/edit.
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Enter the contact information (telephone number or E-mail) into the “Contact information”
box.
Entering postalcode
Enter the installation date into the “Installation date” box. The installation date must be
entered and it can not be later than the current system date.
Enter the contact information of service department (telephone number or E--mail) into the
“Contact information of service department” box.
Entering remark
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Ok
Click the “Ok” button to save the entered/edited information and close the lab information box.
Cancel
Click the “Cancel” button to close the box without saving the changes.
You can set the shortcut code for the following items: “Department”, “Deliverer”, “Gender”
and “Diagnosis”.
The shortcut code is used to facilitate the entry of the foregoing items. You can enter the
shortcut code and press the [Enter] key instead of entering the whole item.
Department
When you log in as a user of administrator level, click the “Menu” button, and then select the
“Shortcut Code” to enter the shortcut code screen.
Adding department
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1. Click the “New” button, and then a message box will pop up.
New added department name must be entered and it can not be the same as
existing ones.
The shortcut code of department is not necessary to be entered, but once
you set them, each of the code must be unique.
Editing department
New added department name must be entered and it can not be the same as
existing ones.
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Deleting department
2. Click “Yes” to delete the department and close the message box, and then it will also be
deleted from the list of department.
Exiting
Click the “Close” button to exit the “Shortcut Code” message box.
Deliverer
At the “Shortcut Code” message box, click the “Deliverer” button to enter its shortcut code
settings.
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Add, edit and delete the deliverer as instructed in the Department section.
Diagnosis
At the “Shortcut Code” message box, click the “Diagnosis” button to enter its shortcut code
settings.
Add, edit and delete the clinical diagnosis as instructed in the Department section.
Gender
At the “Shortcut Code” message box, click the “Gender” button to enter its shortcut code
settings.
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Add, edit and delete the Gender as instructed in the Department section.
The existed shortcut code settings for gender can not be modifired.
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6 Operating Your Analyzer
6.1 Introduction
This chapter provides step--by--step procedures for operating your analyzer on a daily basis.
A flow chart indicating the common daily operating process is presented below.
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Operating Your Analyzer
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
You should only use the Mindray-specified reagents. Store and use the
reagents as instructed by instructions for use of the reagents.
Check if the reagents are connected correctly before using the analyzer.
After installing a new container of reagent, keep it still for a while before
use.
Check and make sure the reagents and waste tubing are properly connected and not bent.
Check and make sure the power cord of the analyzer is properly plugged into the power outlet.
Check and make sure enough printer paper is installed. Check and make sure the power cord
of the printer is properly plugged into power outlet. Check and make sure the printer is properly
connected to the external computer.
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Operating Your Analyzer
Check and make sure the network cable of the external computer is connected to the analyzer
properly.
Check and make sure the keyboard and the mouse are well connected to the external
computer.
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Operating Your Analyzer
1. Place the power switch at the left side of the analyzer in the ON position (I). The power
indicator light will be on.
2. Make sure the indicator light of the analyzer is on.
3. After entering the operation system, double click the “BC-5300 Auto Hematology
Analyzer” icon to run the software.
4. After starting the software, the message box will pop up.
5. Enter the correct user name and password in the “Login” message box.
Before running the software, make sure the network cable of the external
computer is connected to the analyzer properly. The analyzer starts
initializing only when the connection is detected.
If you failed to run the software continuously, please contact Mindray
customer service department or your local distributor immediately.
After startup, please make sure the date/time of the computer is correct.
Up to 12 digits can be entered for user name and password. No Chinese
entry is allowed.
7. During the Initialization, the startup information will be displayed in the operation/status
information area at the bottom of the screen.
8. The whole process lasts 4 to 12 minutes. Time needed for initializing the system depends
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Operating Your Analyzer
9. After the initialization process, you can enter the “Graph” screen to check the background
result.
10. After initialization, if the unhidden sample records in the Worklist are detected, a message
box will pop up.
Click “Yes” to set the first unhidden record in the worklist as the next sample to be run.
Click “No” to hide all the records in the worklist.
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Operating Your Analyzer
If error happens during initialization (e.g. the background results exceed the
Ref. Range), the analyzer will alarm. See Chapter 11 Troubleshooting Your
Analyzer for solutions.
For the background Ref. Range of each parameter, please see Appendix B
Specifications.
The system opens different functions for the users according to their
authority levels. The user’s authority level depends on the user name and
the password when the user logs in the system.
You can click “Logout” button to switch to another user. Enter the new user
name and password in the Login message box, and then click “Ok” to
re-login as a new user.
Running a test when there is an “Abnormal background”, you would get an
unreliable testing result.
During the startup procedure, to start the analyzer first or to run the
software first are both acceptable.
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Operating Your Analyzer
6-7
Operating Your Analyzer
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
When using the Ф12X75 (without the cap) evacuated collection tube, be sure
the volume of the whole blood sample is not less than 0.5mL.
For the whole blood samples to be used for WBC differential or PLT count,
you should store them at room temperature and run them within 8 hours
after collection.
If you do not need the PLT, MCV and WBC differential results, you can store
the samples in a refrigerator (2℃ - 8℃) for 24 hours. You need to warm the
refrigerated samples at room temperature for at least 30 minutes before
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Operating Your Analyzer
running them.
Be sure to mix any sample that has been prepared for a while before running
it.
2. After the preparation is done, the following message box will pop up.
3. Present a clean centrifugal tube to the sample probe and make sure the probe reaches
the bottom of the tube and the keep the tube vertical, as the figure shows, to avoid spills,
hangings and bubbles.
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Operating Your Analyzer
4. Press the aspirate key to start dispensing the diluent. During the procedure, a progress
bar will display.
5. The buzzer sounds when the dispensing is finished, then you can remove the centrifugal
tube. Then, the following message box will display.
6. Add 20μL of capillary blood to the diluent, close the tube cap and shake the tube to mix
the sample.
7. After the prediluted sample is prepared, click the “Cancel” button to exit dispensing the
diluent.
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Operating Your Analyzer
You can also dispense 180μL of diluent by pipette into the tube.
The prepared diluent is only enough for 20 tubes. Therefore, after 20 tubes,
the system needs to run the preparation process again.
Be sure to keep dust from the prepared diluent.
After mixing the capillary sample with the diluent, be sure to wait 3 minutes
before running the sample.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running
it.
Be sure to evaluate predilute stability based on your laboratory’s sample
population and sample collection techniques or methods.
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Operating Your Analyzer
If the analyzer is shut down abnormally, you will lose the worklist
information of the samples that have not been saved yet.
If you want to complete the worklist information after the analysis, see
Chapter 7 Reviewing Sample Results for details.
Click the “Worklist” button on the shortcut area or click “Menu”, then select “Worklist” to enter
the “Worklist” screen.
Click the “New” button, then a new record will be added at the bottom of the worklist and this
blank record is highlighted. All the fields in the information entry area are displayed in defaults
and are activated.
Select the blood mode (“WB” or “PD”) and select the measurement mode (“CBC” or
“CBC+DIFF”) from the two pull-down lists respectively.
In the “CBC” measurement mode, the analyzer only counts the blood cells
without further differentiating the white blood cells. 13 parameters and
histograms of WBC, RBC and PLT are provided in this mode. In the
“CBC+DIFF” mode, the analyzer counts the blood cells and further
differentiates the white blood cells into 5 sub-populations. 23 basic
parameters, 4 RUO parameters, scattergrams and histograms of
WBC/BASO, RBC and PLT are provided in this mode.
Select the reference group for the sample from the “Ref. Group” pull-down list. The analyzer
will judge the test results according to the reference range of the Ref. group. When the results
exceed the reference range, the analyzer will flag.
If you have entered the gender and age of the patient, then the system will
provide a matching Ref. Group automatically.
If the auto-matching Ref. Group is different from the one that you selected
before (excluding the 5 customized Ref. Groups), then the system will adopt
the auto-matching Ref. Group.
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Operating Your Analyzer
Select the draw date from the date control; enter the draw time into the time edit box.
Select the delivery date from the date control and then enter the delivery time into the time edit
box.
The delivery date/time can not be earlier than the draw date/time.
The draw and delivery date/time can not be later than the current system
date/time.
In the Uni-directional LIS/HIS mode, after you entering the patient ID and
pressing the [Enter] key, the matched patient information (including “Last
Name”, “First Name”, “Gender”, “Age”, “Birthday”, “Department” and “Bed
No.”) will be displayed in the screen automatically if there is any. You can
also proceed to edit the information.
In the Bi-directional LIS/HIS mode, the patient information will adopt those
downloaded from the LIS/HIS as default.
Enter the patient name into the “Last Name” and “First Name” boxes.
Enter the gender of the patient into the “Gender” box or select it from the “Gender” pull-down
list.
The analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. The first way is designed for the adult or pediatric patients older than one year;
the second for the infant patients one month to one year; the third for the neonatal patients no
older than one month and the fourth for the neonatal no older than 24 hours. You can choose
only one of the four ways to enter the patient age.
The “Age” pull-down list provides four ways for you to enter the patient age– in years, in
months, in days and in hours, and you can enter the patient age into the box followed by the
age unit.
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Operating Your Analyzer
After entering the birthday, the age field will calculate automatically
according to the difference between the current system date and the
“Birthday”, and then a new result of age and its unit will be displayed in the
age edit box and the unit combo box respectively. Then, the age box will be
unavailable to edit unless the “Birthday” is cleared.
If the entered birthday is later than the current system, it is considered
invalid.
Enter the name of the department, from which the sample came, into the “Department” box or
select it from the “Department” pull-down list.
Enter the bed No. of the patient into the “Bed No.” box.
Enter the name of the deliverer into the “Deliverer” box or select it from the “Deliverer”
pull-down list (if there are previously saved deliverers’ names in the list).
Saving
When finish entering the work list information, you can click the “Save” button or the shortcut
key [F2] to save all the information.
The “Sample ID + Mode” of the current record can not be the same as the
unhidden records of the following status: “To Be Run”, “Running” and
“Error”.
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Operating Your Analyzer
2. Select the measurement mode and fill in sample ID in the dialog box.
3. Press [Enter] from keyboard or click “Ok” from the dialog box to close the dialog box and
start to count.
You can also select “Run as per the worklist” in the “Run” dialog box to
perform counting per the sample information entered in the worklist.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
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Operating Your Analyzer
The sample probe should be kept away from the tube bottom when the
probe is aspirating sample. Otherwise, the aspirated volume may be
imprecise.
The probe tip should not contact the sample tube. Otherwise, the blood may
spill.
Proper reference range shall be selected at the “Setup” screen before
analysis. Otherwise, the results may be flagged erroneously.
If the sample mode is switched from the “Predilute” to “Whole Blood”,
the analyzer will perform the switching sequence automatically and a
progress bar will be displayed on the screen.
If the previously finished sample was run in whole blood mode, but the next
sample will be run in predilute mode, then the message box “Next sample
will be run in Predilute Mode” will pop up on the screen. After you confirm,
the analyzer will perform the cleaning procedure once automatically.
When running as per the worklist, then the next sample ID will always be the
first unhide (or error) sample to be run in the worklist till there is no unhide
sample left or the worklist is empty. If you set the method of entry for the
sample ID as “Auto Increase”, the ID of the latter sample will increase by 1
automatically. If the Sample ID ends with a non-numeric letter, the sample
ID will not increase automatically.
If you directly run the sample with an empty worklist, the default analysis
mode is the same as the previous sample. The default initial analysis mode
is “WB-CBC+DIFF”.
If the Bi-directional LIS/HIS mode is selected, then after the sample ID is
entered/scanned and saved, all the corresponding information will be
obtained from the LIS/HIS, and then the analyzer starts running per the
obtained information. Once the running is finished, the result, graph and
sample/patient information will be uploaded to the LIS/HIS.
1. At the main screen, be sure that the sample mode “WB” is displayed in the “Next Sample”
information area.
2. Shake the whole blood sample as shown below to well mix it.
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Operating Your Analyzer
3. When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is
green), present the whole blood sample to the sample probe.
5. The sample probe will automatically aspirate the sample. When you hear the beep,
remove the sample tube. The analyzer will automatically run the sample and the analysis
status icon and analyzer indicator is flickering in green; the information area of the “Next
sample” will be refreshed.
6. When the analysis is finished, the analysis status icon and analyzer indicator return to
long-last green.
1. At the main screen, be sure that the sample mode “PD” is displayed in the “Next Sample”
information area.
3. When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is
green), carefully open the tube cap and present the prediluted sample to the sample
probe.
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Operating Your Analyzer
5. Press the aspirate key to close the message box and start running.
You can disable the message box before the predilute run. See General
Setup section in chapter 5 Customizing the Analyzer Software for details.
6. The sample probe will automatically aspirate the sample. When you hear the beep,
remove the sample tube. The analyzer will automatically run the sample and the analysis
status icon and analyzer indicator is flickering in green; the information area of the “Next
Sample” will be refreshed.
7. When the analysis is finished, the analysis status icon and analyzer indicator return to
lasting green.
When the analyzer is running, you can perform any operation (including
new, edit and cancel, etc.) to other “To be run” or “Error” samples in the
work list.
When the analyzer is running, you can switch to Graph/Table review screen
to perform operations including data browsing, validating, sample
information editing and printing, etc., and you can also switch to other
screens.
When the analyzer is running, all the functions related to the fluidics
sequence are not available.
If you switch to the Graph review screen from other screens, the latest
record information together with its result and graph will be refreshed and
then displayed.
This analyzer automatically saves sample results. When the maximum number has been
reached, the latest result will overwrite the oldest (already backed up). The maximum number
of automatic saving results is 40,000.
Parameter flags
If the parameter follows an “H” or “L”, it means the analysis result has exceeded the upper
or lower limit of the reference range but still within the display range.
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Operating Your Analyzer
If you see *** as opposed to the result, it means the result is either invalid or out of the
display range.
For the background test, the flags of parameter or flags of abnormal blood
cell differential or morphology are not available.
The analyzer will flag abnormal or suspect WBC, RBC and PLT according to the scattergrams
and histograms. The flag information is defined in the following table:
Left Shift?
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Operating Your Analyzer
The analyzer will flag abnormal or suspect WBC, RBC and PLT according to the scattergrams
and histograms. The following table shows how the flags affect parameter results:
Type
Whole Blood Predilute
Flag
CBC+ CBC+
CBC CBC
5DIFF 5DIFF
WBC √ √ √ √
WBC/BASO channel abnormal
× √ × √
DIFF channel abnormal
√ √ √ √
Aspiration Abnormal
√ √ √ √
System Abnormal
WBC abnormal?
× √ × ×
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Operating Your Analyzer
Left Shift? × √ × ×
Abnormal/Atypical Lymphocyte? × √ × ×
Leucocytosis √ √ √ √
Leucopenia √ √ √ √
Neutrophilia × √ × ×
Neutropenia × √ × ×
Lymphocytosis × √ × ×
Lymphopenia × √ × ×
Monocytosis × √ × ×
Eosinophilia × √ × ×
Basophilia × √ × ×
HGB Abn/Interfere? √ √ × ×
RBC clump? √ √ √ √
Dimorphologic √ √ × ×
Iron Deficiency? √ √ × ×
Anisocytosis √ √ × ×
Microcytosis √ √ √ √
Macrocytosis √ √ √ √
Erythrocytosis √ √ √ √
Anemia √ √ √ √
Hypochromia √ √ √ √
Thrombocytosis √ √ √ √
Thrombopenia √ √ √ √
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Operating Your Analyzer
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
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Operating Your Analyzer
6.7 Worklist
Click the “Worklist” button on the shortcut area or click the “Menu” button, then select
“Worklist” to enter the “Worklist” screen.
The upside of the screen is the worklist; the downside is information entry area including
Sample Info. and Patient Info. The bottom of the screen is the function button area.
In the “Worklist” screen, you can perform the following operations to the worklist.
Click and hold the title of the column then drag the column to the desired position to adjust the
display order.
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Operating Your Analyzer
Click and hold the boundary line between the two columns, then drag the line to adjust the
width of each column.
1. Right click the highlighted record; then the following shortcut menu will pop up:
2. Click “Top” to set the highlighted record as the first record in the worklist.
5. Click “Bottom” to set the highlighted record as the last record in the worklist.
If you click a record in the worklist to highlight it, the corresponding information of the record
will display in the information entry area. You can edit each information field in the information
entry area.
For records whose “Run Status” are “Running”, you can not edit their
“Sample ID” and “Mode”.
The information entry area of the records whose “Run Status” are
“Finished” will be displayed in gray and unavailable to edit and modify. You
can switch to the Graph review or Table review screen to edit and modify the
corresponding information.
When the mouse is moved just on the function buttons, the name of the button and the
corresponding shortcut key will be displayed. For example, when moving the mouse on the
“Save” button, the tips will pop up:
The function buttons at the bottom of the “Worklist” screen and their shortcut keys are shown
in the table.
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Operating Your Analyzer
Search [F5]
Copy [F6]
Hide [F7]
Print [F8]
New
You can click the “New” button to add a new sample record, see Entering Work List
Information section of this chapter for details
Insert
2. Click the “Insert” button to insert a new record before the highlighted record and then the
new added blank row will be highlighted. All the fields in the information entry area are
displayed in defaults and are activated.
3. You can enter the sample/patient information in the information entry area, see Entering
Work List Information section of this chapter for details.
Save
After performing the “New” or “Insert” operation, you can click the “Save” button to save all the
information.
The “Sample ID + Mode” of the current record can not be the same as the
unhidden records of the following status: “To Be Run”, “Running” and
“Error”.
If Bi-directional LIS/HIS is enabled, the terminal software will obtain the
information from LIS/HIS after you clicking the “Save” button, and then
display them in the corresponding field.
Delete
1. Click the” Delete” button, then the “Delete” message box will pop up.
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Operating Your Analyzer
2. Click the radio button “Selected Samples”, “All finished records” or “All records” to
select the records you want to delete.” Selected Samples” are those selected with “√”
marks in the worklist.
3. Click the “Ok” button, and then the message box will pop up.
4. Click the “OK” button to delete the record and refresh the worklist.
The records whose “Run Status” are “Running” can not be deleted.
Search
1. Click the” Search” button, then the “Search” message box will pop up.
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Operating Your Analyzer
2. Click one or more check boxes to define the desired search condition(s).
3. Enter the search content in the edit box of the desired search condition.
4. If you wish to perform the precise search, you can click the “Whole Words Only” check
box to select it; if you wish to perform the fuzzy search (means to search the related
records which contain the content that you entered), you should leave the check box in
blank.
If the first/last record is reached, then the searching cycle will start again
from the last/first record upwards/downwards.
6. A searching cycle will be completed when backing to the initial record. If there is no
matching record found, the prompt message box” No record found!” will pop up at the
screen; otherwise, the prompt message box” Search finished!” will pop up. Click the “Ok”
button to close the message box.
7. You can repeat procedure 2 to 6 to search for other content; or click the “Close” button to
finish searching and close the message box.
Copy
2. Click the “Copy” button to add a new record in worklist and highlight it. The sample ID of
this new added record is empty or will automatically increase by 1 based on the last
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Operating Your Analyzer
sample ID in the worklist; the other information remains the same as the record be copied
from.
If the Sample ID ends with a non-numeric letter, the sample ID will not
increase automatically.
Hide
2. Click the “Hide” button to hide the selected record and display it in gray.
If the selected records include both hidden and unhidden records, when you
click the “Hide” button, all of them will be hidden.
The records whose “Run Status” are “Running” or “Finished” can not be
hidden.
You can edit and delete the hidden record.
Cancel
2. Click the “Cancel” button to cancel the hide and gray display status of the record.
If the selected records are all hidden records, the “Hide” button will be
replaced by the “Cancel” button.
2. Click the “Print” button, and then a message box will pop up.
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Operating Your Analyzer
6.8 Auto-Sleep
When the time for which the analyzer is free from fluidic operations reaches the value you
have set at the "Auto Maintenance" screen, a dialog box will pop up, prompting “Preparing to
sleep, please wait...”. After the preparation, the dialog box closes automatically and the
analyzer is in the auto-sleep status. In this mode, you can still perform any other operations
which do not involve fluidic operations.
NOTE
To change the time when to start the auto-sleep, see 5.3.1 General Setup for
details.
If it is time for auto-sleep, current operations will pause. When the analyzer
is in the auto-sleep status, you can continue the operations.
To cancel the auto-sleep, press the aspirate key and a dialog box of “Canceling the sleeping
mode. Please wait...” will pop up. After the auto-sleep is canceled, the dialog box will close
automatically.
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Operating Your Analyzer
6.9 Shutdown
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
The shutdown procedure includes closing the analyzer and exiting the software. The following
content will introduce the two procedures respectively.
3. During the shutdown procedure, the shutdown information will be displayed in the
information indicating area at the bottom of the screen.
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5. Place the power switch at the left side of the analyzer in the OFF position (O). The
message box will be closed automatically.
If the analyzer disconnects with the computer, you can not perform the
shutdown procedure.
When the analyzer is running or performing other fluidics sequence, do not
shutdown the analyzer forcibly.
If error happens during shutdown procedure, the analyzer will return to the
status before the shutdown procedure is performed, and then alarm. See
Chapter 11 Troubleshooting Your Analyzer for details to remove the error.
You can click the “Restart” button to restart the analyzer and perform the
startup initialization.
You will not exit the software after the shutdown of the analyzer, and you
can still perform operations that are available without the cooperation of the
analyzer.
1. Click the shortcut button “Exit”, or select “Menu”“Exit”“Exit” option, the following
message box will pop up.
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You must shut down the analyzer before exiting the software.
1. Close the external computer according to the shutdown procedures of the operation
system.
You should exit the terminal software first and then turn off the external
computer according to standard procedures. Otherwise, the database of the
terminal software might be lost!
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7 Reviewing Sample Results
7.1 Introduction
The analyzer automatically saves analysis results. Totally 40,000 results can be saved,
including sample information, parameters, flags, scattergrams and histograms.
You can browse sample results either in the table or graph mode.
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Reviewing Sample Results
The “Graph” screen consists of three parts. The upside displays the Sample/Patient Info. The
downside displays the Results, Scattergrams, Histograms, Flags, DIFF Graphs, Microscopic
Exam Results and Blood Type/ESR results in accordance with the Sample/Patient Info. in the
form of tabs including “Data/Graph”, “DIFF”, “Microscopic Exam. and Others” and
“Research”. The bottom displays the functional buttons available in the current screen.
You can enable users of common level to edit the sample ID by setting in the
“Setup” screen, see chapter 5 Customizing the Analyzer Software for
details.
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Reviewing Sample Results
You can edit all the information of the sample except the Mode and Run
Time.
7.2.2 Tabs
After selecting a sample record, you can click the tab in the downside of the screen to see the
corresponding information.
Data/Graph
Click the “Data/Graph” tab to see the data/graph information of the record.
You can select whether to display the four RUOs, the “*” mark and the
corresponding declarations (“*” means “research use only, not for
diagnostic use”) in “Setup” screen, see Chapter 5 Customizing the Analyzer
Software for details.
When the results of Bas% and Bas# are expressed in “*”, the second
histogram discriminator will not be displayed.
For details of how to edit and restore the result, please see the following Edit Result and
Restore Result section of this chapter.
When moving the mouse to any graph of the histogram, an icon of magnifier will appear. Click
the icon, a box of enlarged graph will pop up and you can drag the box at will.
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Reviewing Sample Results
When finish browsing, you can click “╳”on the top right of the box to close it.
DIFF
You can click the “DIFF” tab to check the WBC differential information of the record.
For details of how to edit and restore the result, please see the following function introduction
of the Edit Result and Restore Result section of this chapter.
When moving the mouse to any graph of the histogram, an icon of magnifier will appear. Click
the icon, a box of enlarged graph will pop up and you can drag the box at will.
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Reviewing Sample Results
When finish browsing, you can click “╳”on the top right of the box to close it.
Click the “Microscopic Exam. and Others” tab, you can browse and enter the microscopic
exam and blood type/ESR information of the record.
Click the “Sample Type” combo box; select the sample type as “Venous blood” (default) or
“Capillary”.
Click the “Microscopic exam. time” edit box, and then enter the date and time of microscopic
exam.
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Reviewing Sample Results
The Microscopic exam. time can not exceed the current system time.
You can enter the morphology information for WBC, RBC and PLT respectively into the
multi-line edit box.
You can enter the percentage or other form of differential result of each cell differential into the
edit box next to the cell differential names respectively.
You can enter a value within the range [0.0-100.0] and the unit is “%”.
You can select the blood type of the patient in the “Blood Type/ESR” column. Click the first
combo box next to the blood type, you can select from “Blank”, “A”, “B”, “O” and “AB”; click the
second combo box, you can select from “Blank”, “RH+” and “RH-”.
You can enter the blood ESR value into the edit box follows the “ESR”. If the value exceeds the
Ref. Range, the flags “H”or “L” will appear to indicate the value exceeds the upper limit or
lower limit.
You can modify the reference range of Blood ESR by the following steps:
1. Click the “Set Reference Range” button, and then a message box will pop up. Enter the
upper limit and lower limit of the blood ESR into the edit box “Lower limit” and “Upper limit”
respectively.
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Reviewing Sample Results
2. Click the “Ok” button to save all the settings and refresh the information.
You can enter the value up to 3 numeric characters within the range [0,999].
The upper limit can not be smaller than the lower limit.
The entered reference range of the Blood ESR is only applied to the current
record, and the default range is [0, 20].
Research
Click “Research” tab on the screen, the specific value of each parameter will be displayed.
The specific values of the parameter results that are out of the display range
or without data collected cannot be provided.
Edit of the results in the “Data/Graph” tab will not affect the display of
parameters in the “Research” tab.
The content of this tab can only be viewed and used for research; it cannot
be edited or printed.
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Reviewing Sample Results
The shortcut keys of the function buttons in the graph review screen are shown in the following
table
Save F2
Validate F3
Print F4
Edit Result F5
Restore Result F6
Auto-refresh
At the graph review screen, when browsing the results, you can select to activate or deactivate
the auto-refresh function to display the latest results.
Click the button at the lower right of the graph review screen to make it raised. Later
on, the graph review screen will refresh automatically to display the latest results and graphs if
any.
When the button is raised, all the information fields and buttons at the graph review
screen will be unavailable (displayed in gray) except the records switching column.
Click the button at the lower right of the graph review screen to make it sunk. Later on,
the graph review screen will not refresh even the new results are obtained, but still display the
current sample information, results and graphs that you are now browsing. At the mean time,
the graph will be displayed in normal size as shown below.
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When the button is sunk, all the operations are available to the current displayed
records.
The default status of the button at the graph review screen is sunk.
The status of the button keeps still when you return to the graph
review screen after exiting.
When you browsing records at the graph review screen by using the
switching column, the status of the button automatically changes
into suck.
Save
Click the “Save” button to save the modified information on all tabs of the current result.
Click the “Print” button to print the information, results, histograms and scattergrams of the
current sample.
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You can set the amount of copies for the printed report in the “Setup”
screen.
At the “Setup” screen, you can select whether to print the Flag information
in the report.
Delete
1. Click the “Delete” button, and then a message box will pop up.
2. Click “OK” to delete the current displayed sample record in the “Graph” screen.
The “Delete” button and the corresponding deleting operation are not
available to users of common-level.
Validate
You can enable the users of common level to validate by setting in the
“Setup” screen. Otherwise, the user name and the password of
administrator level are required.
After validating, you can not edit the Sample/Patient Info. and result.
You can not validate the background record.
Cancel (validate)
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with “Validate” when you setting in the “Setup” screen. Otherwise, the user
name and the password of administrator level are required.
After canceling, you can edit the Sample/Patient Info. and result.
Edit Result
1. Click the “Edit Result” button, then the result of each parameter and WBC DIFF results
will be displayed in an edit box for you to edit.
2. After editing, click the “Save” button to save the change and the edit box disappears.
You can enable the users of common level to edit result by setting in the
“Setup” screen. Otherwise, the user name and the password of
administrator level are required.
If the result of one parameter is modified, then the result of other related
parameter(s) will be changed accordingly and the high or low/suspect flags
will also be refreshed.
Only the result of the measurement parameters (WBC, RBC, HGB, HCT and
PLT) and WBC DIFF results can be modified.
After editing and then saving WBC DIFF results, the absolute value of each
DIFF result will be re-calculated and then refreshed.
If the sum of the DIFF results does not equal to 100.00% after being edited,
then the message box “The sum of the DIFF results is not 100.00%!” will pop
up when you clicking the “Save” button.
No matter the sample result is validated or not, as long as it is edited, the
result of the parameter that you modified manually will be flagged with an
“E”. If any parameter result is then changed due to the one that you
modified manually, it will be flagged with an “e”. (“E” or “e” will be displayed
between the parameter result and its unit.)
You can not edit the results of the background.
Restore Result
1. Click the “Restore Result” button, and then the following message box will pop up.
2. Click “OK” to restore the result to the original measurement value and remove the result
edited flags (“E” or “e”).
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The “Table” screen consists of three parts. The upside of the screen displays the sample
records in the form of tables. The downside of the screen displays the Result, Sample/Patient
Info., Microscopic Exam Result and Blood Type/ESR Result of the current sample record in the
form of tabs. The top and bottom of the screen displays the functional buttons available in the
current screen.
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For the error sample record, the content of each information field is
displayed in red.
For the printed sample, its cell in the “Print” column displays “P”. For the
unprinted sample, its cell in the “Print” column is blank.
For the validated sample, its cell in the “Validate” column displays “V”. For
the sample not validated, its cell is blank.
For the transmitted sample, its cell in the “Transmit” column displays “T”.
For the sample not transmitted, its cell is blank.
In the sample records table area, you can perform the following operation:
Click the “Sample List” combo box, then you can select “Samples within today” (default),
“All Samples” and ”Samples found”.
The Review List will display different records according to the different options:
Samples within today Display only the sample records within today
Samples found Display all the sample records met the search requirements.
Click and hold the title of the column then drag the column to the desired position to adjust the
display order.
1. Right click the “Run Date” title, and then a shortcut menu will pop up:
2. Click “Ascending” to rank the records in ascending order of “Run Date + Time” (i.e. the
latest tested sample ranks the last in the list).
3. Click “Descending” to rank the records in descending order of “Run Date + Time” (i.e. the
latest tested sample ranks the first in the list).
The records in the graph screen will be ranked the same way as the table
screen, in ascending/descending order of “Run Date + Time”.
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Switching
Double click a record in the list; the screen will switch to the graph review screen of the record
automatically.
7.3.2 Tabs
After selecting a sample record, you can click the tab in the downside of the screen to see the
corresponding information.
Result
You can click the “Result” tab to see all the results of the highlighted record.
You can select whether to display the four RUOs, the “*” mark and the
corresponding declarations (“*” means “research use only, not for
diagnostic use”) in “Setup” screen, see Chapter 5 Customizing the Analyzer
Software for details.
For details of how to edit and restore the result, please see the following Edit Result and
Restore Result section of this chapter.
Sample/patient information
You can click the “Sample/Patient Info.” tab to see the sample information and patient
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For details to edit information, see Editing work list information section in Chapter 6
Operating Your Analyzer.
Click the “Microscopic Exam. and Others” tab, you can browse and enter the microscopic
exam and blood type/ESR information of the record.
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Click the “Sample Type” combo box, and then select the sample type as “Venous blood”
(default) or “Capillary”.
Click the “Microscopic exam. time” edit box, enter the date and time of microscopic exam.
The Microscopic Exam. Time can not exceed the current system time.
You can enter the morphology information for WBC, RBC and PLT respectively into the
multi-line edit box.
You can enter the percentage or other form of differential result of each cell differential into the
edit box next to the cell differential names respectively.
You can enter a value within the range [0.0-100.0] and the unit is “%”.
You can select the blood type of the patient in the “Blood Type/ESR” column. Click the first
combo box next to the blood type, you can select from “Blank”, “A”, “B”, “O” and “AB”; click the
second combo box, you can select from “Blank”, “RH+” and “RH-”.
Enter the blood ESR value in the edit box follows the “ESR”. If the value exceeds the Ref.
Range, the flags “H”or ”L” will appear to indicate the value exceeds the upper limit or the lower
limit.
You can modify the reference range of Blood ESR by the following steps:
1. Click “Set Reference Range” button, and then a message box will pop up. Enter the
upper limit and lower limit of the blood ESR into the edit box “Lower limit” and “Upper
limit” respectively.
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2. Click the “Ok” button to save all the settings and refresh the information.
You can enter the value up to 3 numeric characters within the range [0,999].
The upper limit can not be smaller than the lower limit.
The entered reference range of the Blood ESR is only applied to the current
record, and the default range is [0, 20].
Research
Click “Research” tab on the screen, the specific value of each parameter will be displayed.
The specific values of the parameter results that are out of the display range
or without data collected cannot be provided.
Edit of the results in the “Data/Graph” tab will not affect the display of
parameters in the “Research” tab.
The content of this tab can only be viewed and used for research; it cannot
be edited or printed.
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corresponding shortcut key will be displayed. For example, when moving the mouse on the
“Save” button, the tips will pop up:
The shortcut keys of the function buttons in the table review screen are shown in the following
table:
Save F2
Validate F3
Print F4
Edit Result F5
Restore Result F6
Batch Validate F7
Search F8
Communication F9
Deselect F10
CV F12
Save
Click the “Save” button to save the modified information on all tabs of the current result.
Search
You can search for the specified sample record from all records in the current list as default.
1. Click the “Search” button, and then a “Search” message box will pop up.
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Select the check box of “Sample ID”, and then enter the desired sample ID into the “Sample
ID” edit box.
Select the check boxes of “Last Name” and “First Name”, and then enter the desired patient
name into the boxes.
Select the check box of “Run Date”, and then select the limits of the run date.
Select the check box of “Gender”, and then click the radio button “Male”, “Female” or “Empty”
to select the patient gender.
Select the check box of “Patient No.”, and then enter the desired patient No. into the “Patient
No.” edit box.
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Select the check box of “Department”, and then enter the desired department name in the
“Department” edit box.
Select the check box of “Bed No.”, and then enter the desired bed No. into the “Bed No.” edit
box.
Select the check box of “Deliverer”, and then enter the desired deliverer into the “Deliverer”
edit box.
Select the check box of the “Validate Status”, and then click the radio button “Validated” or
“Not Validated” to select the validate status.
Select the check box of “Print Status”, and then click the radio button “Printed” or “Not
Printed” to select the print status.
Select the check box of the “Communication Status”, and then click the radio button
“Transmitted” or “Not Transmitted” to select the communication status.
Select the check box of “Whole Words Only”, and then the precise search will be performed;
otherwise, the fuzzy search (means to search the related records which contain the content
that you entered) will be preformed.
Select the check box of “Case Sensitive”, and then the capital letters and small letters in the
edit box will be distinguished when searching; otherwise, the search will be insensitive to the
form the letters (i.e. the capital letters and small letters will not be distinguished).
3. Click “Ok” to perform the search and switch to the “Samples found” list of the “Table”
screen, and the searching results will display.
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The desired record is searched from all the sample records as default.
Validate
Click the “Validate” button to validate the current highlighted record in the list.
You can enable the users of common level to validate by setting in the
“Setup” screen. Otherwise, the user name and the password of
administrator level are required.
After validating, you can not edit the sample/patient information and the
result
You can not validate the background record.
Batch Validate
1. Click the “Batch Validate” button, and then the following message box will pop up.
2. Click the radio button “Selected Samples” or “Specified Samples” to select the records
you want to validate.” Selected Samples” are those selected with “√” marks in the review
list.
3. Click the “Specified Samples” radio button to specify the starting and finishing time of the
Run Date for the record to be validated.
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Cancel (validate)
1. Click the “Print” button, and then a message box will pop up.
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2. Click the radio button “Selected Samples” or “Specified Samples” to select the record
you want to export.” Selected Samples” are those selected with “√” marks in the review
list.
3. Click the “Specified Samples” radio button to set the starting and finishing run date of the
records to be printed.
4. Click the “Report” or “List” radio button to select the print format.
5. When “List” is selected, you can continue to select one of the four print templates, the
default template selected is the “All Para.” template.
You can set the amount of copies of the printed report in the “Setup” screen.
At the “Setup” screen, you can choose whether to print the Flag prompts in
the report or not.
You can select whether automatically de-select printed records or not.
Communication
You can do as follows to transmit the sample record to the LIS/HIS system.
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1. Click “Transmit” button, the following message box will pop up.
2. Click the radio button “Selected Samples” or “Specified Samples” to select the record
you want to transmit.” Selected Samples” are those selected with “√” marks in the review
list.
3. Click the “Specified Samples” radio button to specify the starting and finishing time of the
Run Date for the record to be transmitted.
4. Click “Start” to start transmitting.
Once the transmission starts, if you click the “Transmit” button again, then
the foregoing message box will also pop up but the “Start” button will be
replaced by the “Stop” button. You can click the “Stop” button to stop
transmitting once the transmission of the current sample record is done.
You can select whether to automatically de-select the transmitted records.
You can select whether to automatically delete the transmitted records.
CV
2. Click the “CV” button to start calculating the reproducibility, and then the result message
box will pop up:
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3. Click the “Calculate deviation” button, and then a message box will pop up. You can
check the absolute deviation of the 5 WBC related parameters of percent-style.
4. When finish browsing, you can click the “Close” button to exit.
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Trend Graph
You can check the trend graph of all the parameters of the selected sample record. Do as
follows:
1. Select the desired sample record.
2. Click the “Trend Graph” button, and then a message box with the trend graph of all
parameters of the selected record will pop up.
At least 3 records or at most all records in the review list can be selected.
There is no restriction when selecting the sample records as long as they
are in the review list.
Checking data
Method 1: click the certain data group to move the green line to the place, and then you can
check the data of this group.
Method 2: click the arrow buttons on the “Pos./Total” control to move the green line and check
the data of each group.
Method 3: when the green line is located, you can press the [←] and [→] key on the keyboard
to move the green line and check the data of each group.
Method 4: when the green line is located, you can press the [Home] or [End] key on the
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keyboard to check the first or the last group of data on the graph.
Method 1: click the arrow buttons next to the range to adjust it. The trend graph will refresh
immediately once the range is changed.
Method 2: click the edit box of the range and enter the value into it. After entering, press the
[Enter] key or switch to other focus to refresh the trend graph.
Delete
The “Delete” button and the corresponding deleting operation are not
available for users of common-level.
2. Click the “Delete” button, and then a message box will pop up.
Edit Result
1. Click the “Edit Result” button, and then in the “Result” tab, you can edit the result of each
parameter and WBC DIFF results in the activated edit box.
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You can enable the users of common level to edit result by setting in the
“Setup” screen. Otherwise, the user name and the password of
administrator level are required.
If the result of one parameter is modified, then the result of other related
parameter(s) will be changed accordingly and the high or low/suspect flags
will also be refreshed.
Only the result of the measurement parameters (WBC, RBC, HGB, HCT and
PLT) and WBC DIFF results can be modified.
After editing and then saving WBC DIFF results, the absolute value of each
DIFF result will be re-calculated and then refreshed.
If the sum of the DIFF results does not equal to 100.00% after being edited,
then the message box “The sum of the DIFF results is not 100.00%!” will pop
up when you clicking the “Save” button.
No matter the sample result is validated or not, as long as it is edited, the
result of the parameter that you modified manually will be flagged with an
“E”. If any parameter result is then changed due to the one that you
modified manually, it will be flagged with an “e”. (“E” or “e” will be displayed
between the parameter result and its unit.)
The scattergram of the sample will not be changed even when the
differential result of the WBC is modified.
You can not edit the results of the background.
Restore Result
1. Click the “Restore Result” button, and then the following message box will pop up.
2. Click “OK” to restore the result to the original measurement value and remove the result
edited flags (“E” or “e”).
The users of common level are enabled the authority of “Restore Result”
together with “Edit Result” when setting in the “Setup” screen. Otherwise,
the user name and the password of administrator level are required.
Up to 1000 latest measurement results of original value can be saved by the
analyzer.
You can not restore the results of the background.
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You can back up the data of the sample base in the external computer. Do as follows:
1. At the table review screen, click the “Menu” button, then select “Review” “Data Backup”
on the pop-up menu, and then a message box will pop up.
2. Click the radio button “Selected Samples” or “Specified Samples” to select the record
you want to backup.” Selected Samples” are those selected with “√” marks in the review
list.
3. Click the “Specified Samples” radio button to specify the starting and finishing time of the
Run Date for the record to be backed up.
4. Click “Ok” button, the following dialog box will pop up.
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6. Click the “Save” button, and then a progress bar will pop up.
You can not choose the file format when backing up.
The backup sample record can not be edited and can only be reviewed in
“History”.
The histograms and scattergram will be backed up in the folder of “Bmp” at
the selected location.
You can select whether to automatically clear the "√” mark before the
backed up record.
You can select whether to automatically delete the backed up records.
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1. At the “Table” screen, click the “Menu” button, then select “Review” “Data Export” in
the pop-up menu, and then a “Export” message box will pop up.
2. Click the radio button “Selected Samples” or “Specified Samples” to select the records
you want to export.” Selected Samples” are those selected with “√” marks in the review
list.
3. Click the “Specified Samples” radio button to set the starting and finishing run date of the
record to be printed.
4. Click “Ok” button, and then a message box will pop up.
5. Select the directory and format and enter name for the exported file.
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The default format of the exported files is “.csv” and you can also choose
the “.txt” format.
The exported sample record will keep the same order as displayed in the
table review screen (run time ascending/descending).
You can not review the exported files in “History”, but you can perform the
operations including editing and deleting, etc. to the exported files on an
external computer.
The histograms and scattergram will be exported in the folder of “Bmp” at
the selected location.
You can select whether automatically de-select exported records or not.
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7.6 Auto-backup
When the terminal software connects the analyzer for 4 hours, the backup will be performed
automatically. A progress bar will pop up.
You can not perform any operation during the process of backup.
The record in the sample base will also be backed up automatically when
you exiting the application software.
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7.7 Auto-restore
If the data is damaged in the sample base, but the corresponding auto-backed up data is fine,
then a message box will pop up.
Click “Yes” to close the box and display the auto-backed up data into the sample list.
If you choose not to restore the auto-backed up data and running no new
samples, then the foregoing message box will still pop up when you run the
program again.
A progress bar will be displayed on the screen during auto-restoring.
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7.8 Compare
Click the “Menu” button, and then select “Review” “Compare” from the pop-up menu to
enter the following “Compare” screen.
The “Compare” screen consists of three parts. The top of the screen displays the search
conditions: “Patient ID”, “Last Name”, “First Name” and “Run Date”. The middle of the screen
displays the tab of the patient’s test results and the trend graphs. The available function
buttons are also displayed in the screen.
7.8.1 Tabs
Comparison Summary
Click the “Comparison Summary” tab in the screen to check the test results of the patient.
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If “Display RUO parameters” is not selected in the “Setup” screen, then the
ALY%, LIC%, ALY# and LIC# will not be displayed in the list.
A blank cell of “Result” means no measurement result.
The red flags (“?”, “H” or “L”) indicate the result is either out of limit or
suspect.
The yellow background indicates an edited result.
Result Trend
Click the “Result Trend” tab in the screen to check the trend graphs of the patient.
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You can click the “Select Parameter” combo box at top-left of the screen to select the desired
the trend graph.
If “Display RUO parameters” is not selected in the “Setup” screen, then the
ALY%, LIC%, ALY# and LIC# will not be displayed in the pull-down list of the
combo box.
The x-axis of the “Parameter Trend” shows the No. of the test and the y-axis shows the result
of each test. Up to 30 data points can be displayed in the trend graph. If the matched data are
more than 30 groups, then only the latest 30 ones will be displayed. The data points in the
trend graph are displayed from left to right in the ascending order of Run Date /Time. Thus, the
latest data point places the last.
The scale on the x-axis of the trend graph changes according to the number
of the result.
The scale on the y-axis of the trend graph changes according to the value of
the result.
The down side of the tab displays the result of the single parameter in the form of list. The
corresponding No., run date/time and result are displayed in the list.
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The data in the list corresponds with the data point in the trend graph one by
one.
The red flags (“?”, “H” or “L”) indicate the result is either out of limit or
suspect.
The yellow background indicates an edited result.
Search
You can search for the certain result of the patient by entering the search condition in the top of
the screen.
Enter the patient name into the “Last Name” and “First Name” boxes.
Use the date control to specify the range for the run date.
2. Click the “Search” button to start searching the specified record and the result will be
displayed in the two tabs. You can switch between the two tabs to check the result.
Re-fill
You can click the “Re-fill” button to clear all the entered search conditions and then re-fill.
You can use the “Adjust Parameter Order” function to adjust the following parameter order.
The display order of the parameter in the “Comparison Summary” tab and the parameter
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The display order of the parameter in the combo list of the “Result Trend” tab
1. Click the “Adjust Parameter Order” button, then the following box with the list of the
parameter order will pop up
The right of the parameter list displays the order-adjusting buttons, namely,
“Top”, “Up”, “Down” and “Bottom”.
Click the “Top” button to move the parameter to the top of the list.
Click the “Up” button to move the parameter upward by one position.
Click the “Down” button to move the parameter downward by one position.
Click the “Bottom” button to move the parameter to the bottom of the list
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When the current tab is “Comparison Summary”, you can click the “Print” button to print all
the contents of the summary.
When the current tab is “Result Trend”, you can click the “Print” button to print the displayed
result trend and the result list.
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7.9 Statistics
You can select or enter the “Statistical Condition” to realize the statistics of the workload.
The top of the screen displays the “Statistical Item”, namely, “Department”, “Deliverer”,
“Operator” and “Run Date”. Below the “Statistical Item”, it displays the corresponding
“Statistical Condition”. The corresponding records are displayed in the workload summary
together with the workload statistics. The available function buttons are also displayed in the
screen.
Workload summary
All the records that match the statistical conditions will be displayed in the Workload Summary
and be included to calculate the total workload. The records of the same category (i.e. those
with the same field in the first column) will be taken to calculate the subtotal workload. The
default information fields in the workload summary are “Department”, “Deliverer”, “Operator”,
“Run Date” and “Sample Load”.
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For several results of the same item, they will be displayed in ascending order by run date. Be
aware that not all the statistics results in the summary are displayed in ascending order by run
date.
In the workload summary, the subtotal workload will be displayed below the records of the
same category, and the total workload will be displayed in the last.
Statistics
You can select the desired statistical item and enter the statistical condition to check the
statistics of the workload of the matched record.
1. You can select the desired statistical item by clicking the check box.
2. After selecting the statistical item, the corresponding statistical condition will be activated
for you to enter.
Enter the department name into the “Department” box or select it from the “Department”
pull-down list.
Enter the name of the deliverer into the “Deliverer” box or select it from the “Deliverer”
pull-down list.
Enter the name of the operator into the “Operator” box or select it from the “Operator”
pull-down list.
Use the date control to specify the range for the run date.
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calculated.
3. Click the “Statistics” button to start calculating the workload for the matched records, and
then displays the result in the workload summary.
Re-fill
You can click the “Re-fill” button to clear all the entered statistical conditions and then re-fill.
You can use the “Adjust order” function to adjust the column order (including “Department”,
“Deliverer”, “Operator” and “Run Date”) in the workload summary. Do as follows:
1. Click the “Adjust Order” button, then the following box with the list of the column (field)
order will pop up.
The right of the list displays the order-adjusting buttons, namely, “Top”,
“Up”, “Down” and “Bottom”.
Click the “Top” button to move the field to the top of the list.
Click the “Up” button to move the field upward by one position.
Click the “Down” button to move the field downward by one position.
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Click the “Bottom” button to move the field to the bottom of the list
3. Click “Ok” to save the changes, close the box and back to the “Calculate Workload”
screen. Then, the column order in the workload summary refreshes.
The statistical result will also be refreshed together with the column order.
1. Click the “Print” button, and then a message box will pop up.
2. Click the “Print Summary” or the “Print statistics only” radio button to select the content
you want to print.
“Print Summary” means to print out all the records and statistical results in
the workload summary.
“Print statistics only” means to print out the statistical results only
(including subtotal and total).
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7.10 History
You can review the backed up sample data in “History”. Do as follows:
1. At the Table review screen, click the “Menu” button, and then select “Review” “History”,
and then a dialog box will pop up.
2. Select the desired directory and the file name, and then click “Open” to go to the "Sample
Data History" screen shown as follows.
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If you select another backed up file, then the history data displayed in the
list will be refreshed.
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8 Using the QC Programs
8.1 Introduction
Quality Control (QC) consists of strategies and procedures that measure the precision and
stability of the analyzer. The results imply the reliability of the sample results. QC involves
measuring materials with known, stable characteristics at frequent intervals.
Analysis of the results with statistical methods allows the inference that sample results are
reliable. Mindray recommends you run the QC program daily with low, normal and high level
controls. A new lot of controls should be analyzed in parallel with the current lot prior to their
expiration dates. This may be accomplished by running the new lot of controls twice a day for
five days using any empty QC file. The QC files calculate the mean, standard deviation and
coefficient of variation for each selected parameter. The instrument-calculated means of these
ten runs should be within the expected ranges published by the manufacturer.
The analyzer provides 4 QC programs: L-J QC, X mean QC, X mean R QC and X-B QC.
You should only use the Mindray-specified controls and reagents. Store and
use the controls and reagents as instructed by instructions for use of the
controls and reagents.
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All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
Before analyzing the new lot of controls, you should set a QC file for each lot of controls and
you can edit the QC settings in the QC file by one of the following ways:
Manual entry
1. You can enter the graph screen in one of the following ways:
Click the “Menu” button on the screen; then select “QC””L-J” on the pop-up menu.
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For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.
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You can select the file No. within the range [1, 60].
Different QC files can not have the same lot No. and QC mode.
5. Set QC ID: if you like to run control in the interval of running blood samples, you can set a
specific ID for the control. If such ID is recognized when the analyzer is running blood
samples, it will identify the sample as control automatically. When the running ends, the
result will be stored in the QC file of the corresponding ID.
Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
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number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.
6. Click the “Read File” button, a message box will pop up for you to select the directory.
8. Click the “Ok” button to close the message box shown above, and the following message
box will pop up.
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The QC files for selection are displayed in the form of "Lot No. (Level)".
9. Click the “Ok” button to close the message box and go back to the "Read File" box. The
selected directory is displayed in the "Read From:" edit box.
10. In the "Read File" message box, select the "Read Target/Limits" check box, and click
“Ok” to read the selected QC information to the current QC file.
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If the “Read Target/Limits” is not selected, you have to enter the target and
limits manually.
The expiration date can not be earlier than the current system date.
Different QC files can not have the same lot No. and QC mode.
Manual entry
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””L-J” on the pop-up menu.
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For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.
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You can select the file No. within the range [1, 60].
4. You can enter the lot No. of the control by one of the following ways:
Manual entry
The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters are allowed.
Different QC files can not have the same lot No. and QC mode.
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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].
Different QC files can not have the same lot No. and QC mode.
8. Set QC ID: if you like to run control in the interval of running blood samples, you can set a
specific ID for the control. If such ID is recognized when the analyzer is running blood
samples, it will identify the sample as control automatically. When the running ends, the
result will be stored in the QC file of the corresponding ID.
Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.
9. According to the target list of the corresponding lot No., enter the target and limits into the
edit boxes of the parameters to be included in the QC run.
10. Click the “Save” button to save all the settings of the QC.
If there are saved preset values (Target and Limits) for the current level, you
can read the preset values into the current QC file. For details of calculating
and saving the preset values, see Section 8.2.3 Reviewing QC Results.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””L-J” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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You can select the file No. within the range [1, 60].
4. You can enter the lot No. of the controls by one of the following ways:
Manual entry
The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.
Different QC files can not have the same lot No. and QC mode.
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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].
Different QC files can not have the same lot No. and QC mode.
8. Set QC ID: if you like to run control in the interval of running blood samples, you can set a
specific ID for the control. If such ID is recognized when the analyzer is running blood
samples, it will identify the sample as control automatically. When the running ends, the
result will be stored in the QC file of the corresponding ID.
Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.
9. Click the “Have Preset Values” button to read the saved preset target and limits
(correspond to the current level) into the current QC file.
10. Click the “Save” button to save all the settings of the QC.
Setting Limits
You can take the following steps to adjust the display format of the limits and the calculation
method of the preset limits.
1. Click the “Set Limits” button, and then the following message box will pop up.
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2. Click “By SD” to display the limits in the form of absolute value; click “By CV” to display
the limits in the form of percentage.
3. If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard
deviation to be the limits; if “By CV” is selected, click the “2CV” or “3CV” to select either
double or triple coefficient of variation to be the limits.
4. Click the “Ok” button to save all the settings for the limits.
Click the “Print” button to print the setting information of the current QC file.
Run controls in the interval of running blood samples under sample count screen
After editing the QC information, you can start one of the following QC analyses according to
the selected QC mode.
Whole Blood
Predilute
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All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””L-J” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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3. Select the QC file No. to be run; the screen displays the corresponding file information.
4. Be sure that the level of the control to be run corresponds with the current QC file.
1) Make sure the QC mode is “whole blood” and the analysis status icon and analyzer
indicator is green.
2) Shake the prepared control as shown below to well mix it.
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8. When finish running, the QC results will be displayed in the current screen and be saved
in the QC file automatically.
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All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the graph screen in one of the following ways:
Click the “Menu” button on the screen, and then select “QC””L-J” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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3. Select the QC file No. to be run; the screen displays the corresponding file information.
4. Be sure that the level of the control to be run corresponds with the current QC file.
1) Make sure the QC mode is “Predilute” and the analysis status icon and analyzer indicator is
green.
2) Click the shortcut button “Diluent”, and then a message box will pop up.
3) After the preparation is done, the following message box will pop up.
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4) Present a clean centrifugal tube to the sample probe and make sure the probe reaches the
bottom of the tube and keep the tube vertical, as the figure shows, to avoid spills, hangings
and bubbles.
6) The buzzer sounds when diluent is finished, then you can remove the centrifugal tube.
7) Add 20μL of control to the diluent, close the tube cap and shake the tube to mix the sample.
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8. When finish running, the QC results will be displayed in the current screen and be saved
in the QC file automatically.
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You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before
running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running
it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample
population and sample collection techniques or methods.
Up to 300 QC results can be saved for each QC file.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to switch to the previous or the next QC result.
You can click the button or button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark.
The flags “H” or “L” will appear in front of the result that out of the limits.
The enlarging function is available to the scattergrams and histograms of
the screen. See details for operation in Chapter 7 Reviewing Sample
Results.
For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.
Click the “Print” button to print the results of the current QC Run screen.
After setting special “QC ID” for controls under the “Settings” screen, you can run controls in
the intervals of running blood samples under sample count screen.
Before running blood samples, when you are editing worklist or entering information for the
next sample, be sure to enter the special “QC ID” as “sample ID”. (Refer to 6.6.1 Entering
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Work List Information and 6.6.2 Quick Entering of Next Sample Information for the way to enter
sample IDs)
You can start one of the following QC analyses according to the selected QC mode.
Whole Blood
Predilute
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
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2. Confirm under the main screen that the next sample ID displayed in the “Next Sample”
information area is the set QC ID and the sample mode is whole blood.
4. When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is
green), present the control to the sample probe.
7. After the analysis completes, the QC results will be automatically saved in the
corresponding QC file of the QC ID.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
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2. Confirm under the mian screen that the next sample ID displayed in the “Next Sample”
information area is the set control ID and the sample mode is predilute.
3. Click the shortcut button “Diluent”, a message box will pop up.
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5. Present a clean centrifugal tube to the sample probe and make sure the probe reaches
the bottom of the tube and keep the tube vertical, as the figure shows, to avoid spills,
hangings and bubbles.
7. The buzzer sounds when diluent is finished, then you can remove the centrifugal tube.
8. Add 20μL of control to the diluent, close the tube cap and shake the tube to mix the
sample.
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14. After the running is finished, the QC results will be saved in the QC file of the
corresponding QC ID.
You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before
running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running
it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample
population and sample collection techniques or methods.
Up to 300 QC results can be saved for each QC file.
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You can switch to the “L-J QC Run” screen and click the arrow button in the bottom of the
screen to browse the QC results saved in the corresponding QC file.
You can click the button or button to switch to the previous or the next QC result.
You can click the button or button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark.
The flags “H” or “L” will appear in front of the X mean that out of the limits.
The enlarging function is available to the scattergrams and histograms of
the screen. See details for operation in Chapter 7 Reviewing Sample
Results.
For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.
Click the “Print” button to print the results of the current QC Run screen.
Graph
Table
Graph Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””L-J” on the pop-up menu.
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2. Select the QC file No. you want to review, and then the screen will display the
corresponding information and the graph.
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3. You can drag the scroll bar on the right of the graph vertically to browse the desired graph
of the parameter. You can drag the scroll bar down to the graph horizontally to browse all
the QC results.
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1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line.
3- The operator who run the QC analysis and obtained the QC points located on the green line.
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- The QC points in each graph are displayed from left to right according to the sequence from
the earliest to the latest. The QC points are connected by a line to illustrate the distribution
trend.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
8- The relative position of the QC point located on the green line and the total QC points saved
currently.
The outliers are excluded from the calculation of Mean, SD and CV%.
For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.
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You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to move the green line to the previous or the next
QC point; you can click the button or button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the
QC results of the QC points located on the green line under each parameter.
New Vial
If the reviewed QC results are obtained by analyzing a new vial of control within the same
batch, you should mark the QC points of the new vial to distinguish the QC results from the old.
1. Move the green line to the first QC point of the new vial.
2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3. After another new vial of control (within the same batch) is run and its QC results are
saved, you can continue to mark the current QC point of the new vial according to step 1
and 2.
4. If the current QC point is marked with the blue line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button
will turn back to “New Vial”.
Data Compare
If you wish to compare the graphs of the certain parameter obtained by running controls of
different lot No., do as follows:
1. Click the “Data Compare” button to start selecting the desired graph.
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2. Select the desired QC file No. into the “File No.” box (3 files can be selected at most).
Then, the graph of the selected QC file will be displayed below together with its lot No.,
QC mode and level.
Browse the graph here the same way as instructed in the “Graph” screen.
Be aware that, for controls of different level, their graphs will be
distinguished by the color of orange, black and blue.
Display Order
You can take the following steps to adjust the display order of different graphs.
1. Click the “Display Order” button to check the current display order of the graphs.
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3. You can click the button or button to move parameter upward or downward; you
can click the button or button to move the parameter to the first or the last
position.
4. Click the “Ok” button to refresh the display order of the graphs.
If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can
take the following steps to calculate and save the preset value for each parameter:
1. Click the “Calculate Preset Values” button, and then the screen displays two lines for
you to select the range for calculating the preset values.
2. Click and drag the two lines respectively to locate them as the beginning and the ending
of the range for calculating the preset values.
3. The Mean, SD and CV% (on the right of the graph) will change into the new results
calculated within the selected range.
4. If you wish to save the new results, you can click the “Save Preset Values” button to save
the current Mean, SD and CV% as the preset values for the corresponding level
(high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV%
return to the calculated results of all QC results.
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The calculation and display of the preset values are only available to the
parameter (within the calculation range) which has 3 or more than 3 results
within the limit. Otherwise, the display of the preset values will be empty.
According to the high, normal and low level of the controls, three set of
preset values can be saved respectively.
You can take the following steps to enter the reasons for the outliers:
1. After moving the green line to the desired QC point, you can click the “Outliers” button to
display the QC results, targets and limits of all the parameters located on the green line
(the QC results exceed the limit will be displayed in red) and enter the reasons for the
outliers.
2. You can select the reason form the given ones or enter the reasons (up to 200 characters)
into the edit box manually after selecting “Others”.
3. Click the “Ok” button to save the reasons for the outliers and exit.
If you enter the reason for the group of QC points whose results are actually
within the limits, then their corresponding QC data both in the QC Graph
and QC Table will be displayed in the color of red. And the data will return to
black if you cancel the reason and then save the changes.
Delete
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1. If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.
4. Click the “Ok” button and then confirm to delete the selected data.
Click the “Print” button to print all the file information and graphs of the parameters of the
current QC file.
The green line and the corresponding values of the QC points will not be
printed.
Table Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the Table screen by one of the following ways:
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Click the “Menu” button on the screen, and then select “QC””L-J” on the pop-up menu.
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3. Select the QC file No. you want to review, and then the screen will display the
corresponding information and the table.
4. You can drag the scroll bar on the right of the table vertically to browse the desired table of
the parameter. You can drag the scroll bar down to the table horizontally to browse all the
QC results.
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1- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
2- QC Result
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: The flag “H” or “L” will be used to prompt the result that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.
For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to highlight the previous or the next QC result;
you can click the button or button to highlight the first or the last QC result in the
table.
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Delete
1. If you wish to delete a single QC result, click the column contains the desired QC result; if
you wish to delete all the data, perform step 2 directly.
4. Click the “Ok” button and then confirm to delete the selected data.
1. Click the “Print” button, and then you can select “All Data” or “Specified Data” to be
printed.
2. Click the “All Data” button and then click the “Ok” button to print all the file information
and tables of the parameters of the current QC file; after clicking the “Specified Data”
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button, you can select the starting and finishing date (the saved date of the QC results) for
printing, then click the “Ok” button to print the specified data.
Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1. Click the “Communication” button, and then you can select “All Data” or “Specified
Data” to be transmitted.
2. Click the “All Data” button and then click the “Start” button to transmit the information of
the current QC file and QC data. After clicking the “Specified Data” button, you can
specify a date range (the date when the QC result was saved), then click the “Ok” button
to transmit the specified data. The “LIS/HIS connected” icon on the status bar of the
screen will flicker during transmission.
3. While transmitting, the “Start” button in the pop-up message box will be replaced by
“Stop”. You can click the “Stop”button to stop transmitting.
Data Backup
If you wish to backup the information and the result of the current QC file, do as follows:
1. Click the “Data Backup” button, a message box will pop up.
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2. Select the backup directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the backup data (the default name is [L-J_QC_date saved_time
saved]).
5. When the backup is finished, a message box will pop up, and then click “Ok” to exit.
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The backup data can not be modified. You can review the data in “History”
screen.
You can click the “Cancel” button to cancel backup when it is in process.
Be sure to backup data regularly.
Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1. Click the “Data Export” button, and then a message box will pop up.
2. Select the export directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the export data (the default name is [L-J_QC_date saved_time
saved]).
6. When the export is finished, a message box will pop up, and then click “Ok” to exit.
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You can modify the exported data but can not review the data in the
“History” screen.
You can click the “Cancel” button to cancel export when it is in process.
History
1. Click the “History” button, and then a message box will pop up.
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4. The display format and the function button are the same as the QC table screen. Browse,
print, transmit and export the data as instructed in the section of QC Table Review.
Single parameter QC graph is the QC graph of one parameter under the L-J QC mode.
Click “Menu” “QC” ”L-J QC”, and then click the “Single Para. QC Graph” tab to enter the
following screen.
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The single para. QC graph screen consists of the file information area, QC graph area and the
comments area.
QC graph area
You can select the parameter to plot QC graph from the “Parameter” pull-down list, and select
the plotting mode from the “Plotting” pull down list: “By QC Date”, “1/Day”, “All”.
The default values of the “Mean” and “SD” boxes are calculated from all the valid QC points on
the graph of the selected parameter in the current QC file by the default plotting mode. You can
edit the values manually.
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If there are less than 3 valid QC points of the current parameter, the mean
and SD will be null.
If you select “By QC Date” or “1/Day” plotting mode, and there are more
than 1 QC point in one day, the points will all be displayed in the graph, but
only the latest one will be the connecting point of the plot.
Drag the scroll bar after setting up all the information, and the QC graph will be plotted
automatically and the analysis results and operator information will be displayed under the
graph.
Comments area
This area displays the conclusion drawn based on the preset rule of outliers, which can be
edited by operators.
Click the arrow buttons under the screen to browse all the QC points.
You can click the button or button to highlight the previous or the next QC point; you
can click the button or button to highlight the first or the last QC point in the graph.
New Vial
If the reviewed QC results are obtained by analyzing a new vial of control within the same
batch, you should mark the QC points of the new vial to distinguish the QC results from the old.
1. Move the green line to the first QC point of the new vial.
2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3. After another new vial of control (within the same batch) is run and its QC results are
saved, you can continue to mark the current QC point of the new vial according to step 1
and 2.
4. If the current QC point is marked with the blue line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button
will turn back to “New Vial”.
Calculate Target
Click the “Calculate” button, the following screen will pop up.
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After selecting the date range, the mean, SD and CV will be calculated and displayed in to the
corresponding boxes automatically.
Click “Apply” to enter the calculated target into the single para. QC graph screen, and then
click “OK” to save the target and close the dialog box. Click “Cancel” to exit the “Calculate”
screen without saving the calculated target.
If there are no data in the selected date range, a prompt will be displayed:
“Not enough data! Reselect a date range and make sure there are more than
5 groups of valid data.”
Save
Click “Save” to save the mean and SD (including the manually edited values and the values
obtained by calculating target) and display them on the bottom left of the QC graph.
Monthly QC Graph
Monthly QC graph is the QC graph of one parameter of the high, normal and low levels within
one month.
Click “Menu” “QC” ”L-J QC”, and then click the “Monthly QC Graph” tab to enter the
following screen.
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The monthly QC graph screen consists of the file information area and QC graph area.
After you set the above conditions, the matching QC files will be acquired and the Lot No., exp.
Date, X mean and SD will be displayed in the boxes of the corresponding QC levels. If no data
is acquired, the boxes will be null.
If the “X Mean” and “SD” boxes are both null, their values cannot be edited, otherwise you can
edit the values of X mean and SD, then click “Save” to save the change.
Two QC files of each QC level can be displayed in one month; if there are
more than two QC files, the latest two will be displayed.
QC graph area
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Drag the scroll bar after setting up all the information, the QC graph will be plotted
automatically and the QC point No., analysis results and operator information will be displayed
under the QC graph. If there are QC points in the graph, the Lot No., X mean, SD and CV% will
be displayed above the graph.
Each screen of the QC graph can display 31 groups of QC data. To view more QC data, drag
the horizontal scroll bar.
Click the arrow button under the screen to browse all the QC points.
You can click the button or button to highlight the previous or the next QC point; you
can click the button or button to highlight the first or the last QC point in the graph.
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All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
Before analyzing a new batch of controls, you should set a QC file for each lot of controls and
edit the QC settings in the QC file by one of the following ways:
Manual entry
1. You can enter the graph screen in one of the following ways:
Click the “Menu” button on the screen; then select “QC””X mean” on the pop-up menu.
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For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.
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You can select the file No. within the range [1, 60].
Different QC files can not have the same lot No. and QC mode.
5. Click the “Read File” button, a message box will pop up for you to select the directory.
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7. Click the “Ok” button to close the message box shown above, and the following message
box will pop up.
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The QC files for selection are displayed in the form of "Lot No. (Level)".
8. Click the “Ok” button to close the message box and go back to the "Read File" box. The
selected directory is displayed in the "Read From:" edit box.
9. In the "Read File" message box, select the "Read Target/Limits" check box, and click
“Ok” to read the selected QC information to the current QC file.
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If the “Read Target/Limits” is not selected, you have to enter the target and
limits manually.
The expiration date can not be earlier than the current system date.
Different QC files can not have the same lot No. and QC mode.
Manual entry
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””X mean” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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You can select the file No. within the range [1, 60].
4. You can enter the lot No. of the controls by one of the following ways:
Manual entry
The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.
Different QC files can not have the same lot No. and QC mode.
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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].
Different QC files can not have the same lot No. and QC mode.
8. Enter the target and limits into the edit boxes of the parameters to be included in the QC
run according to the target list of the corresponding lot No.
9. Click the “Save” button to save all the settings of the QC.
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If there are the saved preset values (Target and Limits) for the current level,
you can read the preset values into the current QC file. For details of
calculating and saving the preset values, see Section 8.3.3 Reviewing QC
results.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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You can select the file No. within the range [1, 60].
4. You can enter the lot No. of the controls by one of the following ways:
Manual entry
The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.
Different QC files can not have the same lot No. and QC mode.
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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].
Different QC files can not have the same lot No. and QC mode.
8. Click the “Have Preset Values” button to read-in the saved preset target and limits
(correspond to the current level) into the current QC file.
9. Click the “Save” button to save all the settings of the QC.
Setting Limits
You can take the following steps to adjust the display format of the limits and the calculation
method of the preset limits.
1. Click the “Set Limits” button, and then the following message box will pop up.
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2. Click “By SD” to display the limits in the form of absolute value; click “By CV” to display
the limits in the form of percentage.
3. If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard
deviation to be the limits; if “By CV” is selected, click the “2CV” or “3CV” to select either
double or triple coefficient of variation to be the limits.
4. Click the “Ok” button to save all the settings for the limits.
Click the “Print” button to print the setting information of the current QC file.
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Whole Blood
Predilute
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
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1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
3. Select the QC file No. to be run; the screen displays the corresponding file information.
4. Be sure that the level of the control to be run is the same with the current QC file.
1) Make sure the QC mode is “whole blood” and the analysis status icon and analyzer
indicator is green.
2) Shake the prepared control as shown below to well mix it.
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8) Mix the control well again, to run the control for the second time according to the prompt.
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You can click the “Cancel” button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.
8. When finish running, the QC results (values of the two QC runs and the X mean) will be
displayed in the current screen and be saved in the QC file automatically.
When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.
Up to 300 QC results (X mean) can be save for each QC file.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
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1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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3. Select the QC file No. to be run; the screen displays the corresponding file information.
4. Be sure that the level of the control to be run is the same with the current QC file.
1) Make sure the QC mode is “Predilute” and the analysis status icon and analyzer indicator is
green.
2) Click the shortcut button “Diluent”, and then a message box will pop up.
3) After the preparation is done, the following message box will pop up.
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4) Present a clean centrifugal tube to the sample probe and make sure the probe reaches the
bottom of the tube and keep the tube vertical, as the figure shows, to avoid spills, hangings
and bubbles.
6) The buzzer sounds when diluent is finished, then you can remove the centrifugal tube.
7) Add 20μL of control to the diluent, close the tube cap and shake the tube to mix the sample.
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15) Mix the control in the centrifugal tube well again, to run the control for the second time
according to the prompt.
You can click the “Cancel” button in the message boxto cancel the second
run and the results obtained in the first run will not be saved as well.
8. When finish running, the QC results (values of the two QC runs and the X mean) will be
displayed in the current screen and be saved in the QC file automatically.
You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before
running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running
it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample
population and sample collection techniques or methods.
Up to 300 QC results can be saved for each QC file.
When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.
Up to 300 QC results (X mean) can be save for each QC file.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to switch to the previous or the next QC result.
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You can click the button or button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark.
The flags “H” or “L” will appear in front of the X mean that out of the limits.
The enlarging function is available to the scattergrams and histograms of
the screen. See details for operation in Chapter 7 Reviewing Sample
Results.
For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.
Click the “Print” button to print the results of the current QC Run screen.
After running controls, you can review the QC results in the following two ways:
Graph
Table
Graph Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean” on the pop-up menu.
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2. Select the QC file No. you want to review, and then the screen will display the
corresponding information and the graph.
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3. You can drag the scroll bar on the right of the graph to browse the desired graph of the
parameter. You can drag the scroll bar down to the graph horizontally to browse all the QC
results.
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1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line.
3- The operator who run the QC analysis and obtained the QC points located on the green line.
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- The QC points in each graph are displayed from left to right according to the sequence from
the earliest to the latest. The QC points are connected by a line to illustrate the distribution
trend.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
8- The relative position of the QC point located on the green line and the total QC points saved
currently.
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You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to move the green line to the previous or the next
QC point; you can click the button or button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the
QC results of the QC points located on the green line under each parameter.
New Vial
If the reviewed QC results are obtained by analyzing a new vial of control within the same
batch, you should mark the QC points of the new vial to distinguish the QC results from the old.
1. Move the green line to the first QC point of the new vial.
2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3. After another new vial of control (within the same batch) is run and its QC results are
saved, you can continue to mark the current QC point of the new vial according to step 1
and 2.
4. If the current QC point is marked with the blue line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button
will turn back to “New Vial”.
Data Compare
If you wish to compare the graphs of the certain parameter obtained by running controls of
different lot No., do as follows:
1. Click the “Data Compare” button to start selecting the desired graph.
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2. Select the desired QC file No. into the “File No.” box (3 files can be selected at most).
Then, the graph of the selected QC file will be displayed below together with its lot No.,
QC mode and level.
Browse the graph here the same way as instructed in the “Graph” screen.
Be aware that, for controls of different level, their graphs will be
distinguished by the color of orange, black and blue.
Display Order
You can take the following steps to adjust the display order of different graphs.
1. Click the “Display Order” button to check the current display order of the graphs.
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3. You can click the button or button to move parameter upward or downward; you
can click the button or button to move the parameter to the first or the last
position.
4. Click the “Ok” button to refresh the display order of the graphs.
If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can
take the following steps to calculate and save the preset value for each parameter:
1. Click the “Calculate Preset Values” button, and then the screen displays two lines for
you to select the range for calculating the preset values.
2. Click and drag the two lines respectively to locate them at the beginning and the ending of
the range for calculating the preset values.
3. The Mean, SD and CV% (on the right of the graph) will change into the new results that
obtained by calculating within the selected range.
4. If you wish to save the new results, you can click the “Save Preset Values” button to save
the current Mean, SD and CV% as the preset values for the corresponding level
(high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV%
return to the calculated results of all QC results.
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The calculation and display of the preset values are only available to the
parameter (within the calculation range) which has 3 or more than 3 results
within the limit. Otherwise, the display of the preset values will be empty.
According to the high, normal and low level of the controls, three sets of
preset values can be saved respectively.
You can take the following steps to enter the reasons for the outliers:
1. After moving the green line to the desired QC point, you can click the “Outliers” button to
display the QC results, targets and limits of all the parameters located on the green line
(the QC results exceed the limit will be displayed in red) and enter the reasons for the
outliers.
2. You can select the reason form the given ones or enter the reasons (up to 200 characters)
into the edit box manually after selecting “Others”.
3. Click the “Ok” button to save the reasons for the outliers and exit.
If you enter the reason for the group of QC points whose results are actually
within the limits, then their corresponding QC data both in the QC Graph
and QC Table will be displayed in the color of red. And the data will return in
the color of black if you cancel the reason and then save the changes.
Delete
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1. If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.
4. Click the “Ok” button and then confirm to delete the selected data.
Click the “Print” button to print all the file information and graphs of the parameters of the
current QC file.
The green line and the corresponding values of the QC points will not be
printed.
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Table Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the Table screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean” on the pop-up menu.
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3. Select the QC file No. you want to review, and then the screen will display the
corresponding information and the table.
4. You can drag the scroll bar on the right of the table vertically to browse the desired table of
the parameter. You can drag the scroll bar down to the table horizontally to browse all the
QC results.
1- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
2- QC Result
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: The flag “H” or “L” will be used to prompt the result (X mean) that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
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current QC file.
You can click the button or button to highlight the previous or the next QC result;
you can click the button or button to highlight the first or the last QC result in the
table.
Delete
1. If you wish to delete a single QC result, click the column contains the desired QC result; if
you wish to delete all the data, perform step 2 directly.
4. Click the “Ok” button and then confirm to delete the selected data.
1. Click the “Print” button, and then you can select “All Data” or “Specified Data” to be
printed.
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2. Click the “All Data” button and then click the “Ok” button to print all the file information
and tables of the parameters of the current QC file; after clicking the “Specified Data”
button, you can select the starting and finishing date (the saved date of the QC results) for
printing, then click the “Ok” button to print the specified data.
Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1. Click the “Communication” button, and then you can select “All Data” or “Specified
Data” to be transmitted.
2. Click the “All Data” button and then click the “Start” button to transmit the information of
the current QC file and QC data. After clicking the “Specified Data” button, you can
specify a date range (the date when the QC result was saved), then click the “Ok” button
to transmit the specified data. The “LIS/HIS connected” icon on the status bar of the
screen will flicker during transmission.
3. While transmitting, the “Start” button in the pop-up message box will be replaced by
“Stop”. You can click the “Stop”button to stop transmitting.
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Data Backup
If you wish to backup the information and the result of the current QC file, do as follows:
1. Click the “Data Backup” button, a message box will pop up.
2. Select the backup directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the backup data (the default name is [X_QC_date saved_time saved]).
5. When the backup is finished, a message box will pop up, and then click “Ok” to exit.
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The backup data can not be modified. You can review the data in “History”
screen.
You can click the “Cancel” button to cancel backup when it is in process.
Be sure to backup data regularly.
Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1. Click the “Data Export” button, and then a message box will pop up.
2. Select the export directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the export data (the default name is [X_QC_date saved_time saved]).
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6. When the export is finished, a message box will pop up, and then click “Ok” to exit.
You can modify the exported data but can not review the data in the
“History” screen.
You can click the “Cancel” button to cancel export when it is in process.
History
1. Click the “History” button, and then a message box will pop up.
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4. The display format and the function button are the same as the QC table screen. Browse,
print, transmit and export the data as instructed in the section of QC Table Review.
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All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
Before analyzing the new lot of controls, you should set a QC file for each lot of controls and
you can edit the QC settings in the QC file by one of the following ways:
Manual entry
Manual entry
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””X mean R” on the pop-up
menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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You can select the file No. within the range [1, 60].
4. You can enter the lot No. of the controls by one of the following ways:
Manual entry
The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.
Different QC files can not have the same lot No. and QC mode.
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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].
Different QC files can not have the same lot No. and QC mode.
8. Click the “Save” button to save all the settings of the QC.
Click the “Print” button to print the setting information of the current QC file.
Whole Blood
Predilute
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
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1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean R” on the pop-up
menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
3. Select the QC file No. to be run; the screen displays the corresponding file information.
4. Be sure that the level of the control to be run is the same with the current QC file.
1) Make sure the QC mode is “whole blood” and the analysis status icon and analyzer
indicator is green.
2) Shake the prepared control as shown below to well mix it.
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8) Mix the control well again, to run the control for the second time according to the prompt.
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You can click the “Cancel” button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.
8. When finish running, the QC results (values of the two QC runs, X mean and range R) will
be displayed in the current screen and be saved in the QC file automatically.
When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.
Up to 300 QC results (X mean and range R) can be saved for each QC file.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
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1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””X mean R” on the pop-up
menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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3. Select the QC file No. to be run; the screen displays the corresponding file information.
4. Be sure that the level of the control to be run is the same with the current QC file.
1) Make sure the QC mode is “Predilute” and the analysis status icon and analyzer indicator is
green.
2) Click the shortcut button “Diluent”, and then a message box will pop up.
3) After the preparation is done, the following message box will pop up.
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4) Present a clean centrifugal tube to the sample probe and make sure the probe reaches the
bottom of the tube and the keep the tube vertical, as the figure shows, to avoid spills, hangings
and bubbles.
6) The buzzer sounds when diluent is finished, then you can remove the centrifugal tube.
7) Add 20μL of control to the diluent, close the tube cap and shake the tube to mix the sample.
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15) Mix the control in the centrifugal tube well again, to run the control for the second time
according to the prompt.
You can click the “Cancel” button in the message boxto cancel the second
run and the results obtained in the first run will not be saved as well.
8. When finish running, the QC results (values of the two QC runs, X mean and range R) will
be displayed in the current screen and be saved in the QC file automatically.
You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before
running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running
it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample
population and sample collection techniques or methods.
Up to 300 QC results can be saved for each QC file.
When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.
Up to 300 QC results (X mean and range R) can be saved for each QC file.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
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current QC file.
You can click the button or button to switch to the previous or the next QC result.
You can click the button or button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark.
If 10 batches of QC results (20 times of QC runs) are obtained, the flags “H”
or “L” will appear in front of the X and R that are out of the limits.
The enlarging function is available to the scattergrams and histograms of
the screen. See details for operation in Chapter 7 Reviewing Sample
Results.
Click the “Print” button to print the results of the current QC Run screen.
Graph
Table
Graph Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous.Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean R” on the pop-up
menu.
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2. Select the QC file No. you want to review, and then the screen will display the
corresponding information and the graph.
3. You can drag the scroll bar on the right of the graph to browse the desired graph of the
parameter. You can drag the scroll bar down to the graph horizontally to browse all the QC
results.
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1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line.
3- The operator who run the QC analysis and obtained the QC points located on the green line
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- The QC points in each graph are displayed from left to right according to the sequence from
the earliest to the latest. The QC points are connected by a line to illustrate the distribution
trend.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
8- The relative position of the QC point located on the green line and the total QC points saved
currently.
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results.
The outliers are excluded from the calculation of Mean, SD and CV%.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to move the green line to the previous or the next
QC point; you can click the button or button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the
QC results of the QC points located on the green line under each parameter.
New Vial
If the reviewed QC results are obtained by analyzing a new vial of control within the same
batch, you should mark the QC points of the new vial to distinguish the QC results from the old.
1. Move the green line to the first QC point of the new vial.
2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3. After another new vial of control (within the same batch) is run and its QC results are
saved, you can continue to mark the current QC points of the new vial according to step 1
and 2.
4. If the current QC point is marked with the blue line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button
will turn back to “New Vial”.
Data Compare
If you wish to compare the graphs of the certain parameter obtained by running controls of
different lot No., do as follows:
1. Click the “Data Compare” button to start selecting the desired graph.
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2. Select the desired QC file No. into the “File No.” box (3 files can be selected at most).
Then, the graph of the selected QC file will be displayed below together with its lot No.,
QC mode and level.
Browse the graph here the same way as instructed in the “Graph” screen.
Be aware that, for controls of different level, their graphs will be
distinguished by the color of orange, black and blue.
Display Order
You can take the following steps to adjust the display order of different graphs.
1. Click the “Display Order” button to check the current display order of the graphs.
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3. You can click the button or button to move parameter upward or downward; you
can click the button or button to move the parameter to the first or the last
position.
4. Click the “Ok” button to refresh the display order of the graphs.
You can take the following steps to enter the reasons for the outliers:
1. After moving the green line to the desired QC point, you can click the “Outliers” button to
display the QC results, total mean and average range of all the parameters located on the
green line (the QC results exceed the limit will be displayed in red) and enter the reasons
for the outliers.
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2. You can select the reason form the given ones or enter the reasons (up to 200 characters)
into the edit box manually after selecting “Others”.
3. Click the “Ok” button to save the reasons for the outliers and exit.
If you enter the reason for the group of QC points whose results are actually
within the limits, then their corresponding QC data both in the QC Graph
and QC Table will be displayed in the color of red. And the data will return in
the color of black if you cancel the reason and then save the changes.
Delete
1. If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.
4. Click the “Ok” button and then confirm to delete the selected data.
Click the “Print” button to print all the file information and graphs of the parameters of the
current QC file.
The green line and the corresponding values of the QC points will not be
printed.
Table Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the Table screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC”” X mean R” on the pop-up
menu.
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3. Select the QC file No. you want to review, and then the screen will display the
corresponding information and the table.
4. You can drag the scroll bar on the right of the table vertically to browse the desired table of
the parameter. You can drag the scroll bar down to the table horizontally to browse all the
QC results.
1- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
2- QC Result
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: If 10 batches of QC results (20 times of QC runs) are obtained, the flag “H” or “L”
will be used to prompt the result (X mean) that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.
The total mean, average range and flag for the parameters will be provided
only after 10 batches of QC results (20 times of QC runs) are obtained.
The values of the QC result are the X mean and the range R of each batch of
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QC results.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to highlight the previous or the next QC result;
you can click the button or button to highlight the first or the last QC result in the
table.
Delete
1. If you wish to delete a single QC result, click the column contains the desired QC result; if
you wish to delete all the data, perform step 2 directly.
4. Click the “Ok” button and then confirm to delete the selected data.
1. Click the “Print” button, and then you can select “All Data” or “Specified Data” to be
printed.
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2. Click the “All Data” button and then click the “Ok” button to print all the file information
and tables of the parameters of the current QC file; after clicking the “Specified Data”
button, you can select the starting and finishing date (the saved date of the QC results) for
printing, then click the “Ok” button to print the specified data.
Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1. Click the “Communication” button, and then you can select “All Data” or “Specified
Data” to be transmitted.
2. Click the “All Data” button and then click the “Start” button to transmit the information of
the current QC file and QC data. After clicking the “Specified Data” button, you can
specify a date range (the date when the QC result was saved), then click the “Ok” button
to transmit the specified data. The “LIS/HIS connected” icon on the status bar of the
screen will flicker during transmission.
3. While transmitting, the “Start” button in the pop-up message box will be replaced by
“Stop”. You can click the “Stop”button to stop transmitting.
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Data Backup
If you wish to backup the information and the result of the current QC file, do as follows:
1. Click the “Data Backup” button, a message box will pop up.
2. Select the backup directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the backup data (the default name is [X-R_QC_date saved_time
saved]).
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5. When the backup is finished, a message box will pop up, and then click “Ok” to exit.
The backup data can not be modified. You can review the data in “History”
screen.
You can click the “Cancel” button to cancel backup when it is in process.
Be sure to backup data regularly.
Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1. Click the “Data Export” button, and then a message box will pop up.
2. Select the export directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the export data (the default name is [X-R_QC_date saved_time
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saved]).
6. When the export is finished, a message box will pop up, and then click “Ok” to exit.
You can modify the exported data but can not review the data in the
“History” screen.
You can click the “Cancel” button to cancel export when it is in process.
History
1. Click the “History” button, and then a message box will pop up.
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4. The display format and the function button are the same as the QC table screen. Browse,
print, transmit and export the data as instructed in the section of QC Table Review.
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It is recommended the X-B analysis be activated when the sample volume of your laboratory is
greater then 100 samples per day. The analyzer can save maximum 500 X-B QC results.
When the saved QC results have reached the maximum number, the newest result will
overwrite the oldest.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
At the X-B QC setting screen, you can edit the QC information and configure the sample
validity setup.
Before the X-B analysis, you should finish editing the QC information by one of the following
ways:
Manual entry
Manual entry
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””X-B” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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3. In the “Samples/Batch” edit box, you can enter the amount of samples [within the range
20(recommended) to 200] to be included in calculating for an X-B QC point.
4. Click the “Open” button of “X-B” to open the X-B QC, and from the time on, all the valid
samples results will be included to calculate the X-B.
All the targets and limits for the QC parameters shall be entered without
empty.
When first use, the default setting will provide the Initial values for the
targets and limits of the three QC parameters.
If the QC data have existed in the QC file, you are not allowed to edit the
target and limits.
6. Click the “Save” button to save all the settings of the QC.
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If there are the saved preset values (Target and Limits) for the X-B QC, you
can read-in the preset values into the X-B QC file. For details of calculating
and saving the preset values, see Section 8.5.3 Reviewing QC results.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen then select “QC””X-B” on the pop-up menu.
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For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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3. In the “Samples/Batch” edit box, you can enter the amount of samples [within the range
20(recommended) to 200] to be included in calculating for an X-B QC point.
4. Click the “Open” button of “X-B” to open the X-B QC, and from the time on, all the
samples results will be included to calculate the X-B.
5. Click the “Have Preset Values” button to read-in the saved preset target and limits into
the X-B QC file.
All the targets and limits for the QC parameters shall be entered without
empty.
If some QC parameters have no preset values, you should enter the target
and limits for them manually.
If the QC data have existed in the QC file, you are not allowed to have the
preset values.
6. Click the “Save” button to save all the settings of the QC.
Setting Limits
You can take the following steps to adjust the display format of the limits and the calculation
method of the preset limits.
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1. Click the “Set Limits” button, and then the following message box will pop up.
2. Click “By SD” to display the limits in the form of absolute value; click “By CV” to display
the limits in the form of percentage.
3. If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard
deviation to be the limits; if “By CV” is selected, click the “2CV” or “3CV” to select either
double or triple coefficient of variation to be the limits.
4. Click the “Ok” button to save all the settings for the limits.
Restoring defaults
When editing the QC settings, if you wish to restore the target and limits to the defaults, you
can click the “Restore Default” button to read-in the defaults to the X-B QC file.
MCV: 89.5fL
MCH: 30.5pg
MCHC: 340g/L
MCV: 2.7 fL
MCH: 0.9 pg
MCHC: 10 g/L
If the QC data have existed in the QC file, you are not allowed to restore
defaults.
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In X-B QC, sample results conforming to any of the following conditions will be considered as
invalid and can not be used in the QC calculation.
2. Background results;
5. Calibration data;
6. Results generated while there are errors which could affect the accuracy of the results
(insufficient aspiration volume or clogging for example).
"Sample Validity Setup" is to set up the ranges of valid RBC, MCV, MCH and MCHC results.
Only when the results of all these four parameters are within the specified ranges, the sample
results can be used for X-B QC calculation. Do as follows to set the sample validity:
Click the “Menu” button on the screen; then select “QC””X-B” on the pop-up menu.
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For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.
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3. Set the upper and lower limits of the four parameters in the "Sample Validity Setup"
area.
5. If any value you entered is out of range or any upper limit entered is less than the
corresponding lower limit, the following message box will pop up when you click the
"Save" button.
6. Click "Ok" to go to the QC setting screen and modify the invalid values.
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50fL≤MCV≤150fL
20pg≤MCH≤40pg
240g/L≤MCHC≤440g/L
The validity entry range for RBC is its linearity range, and the validity entry
ranges for other three parameters are those of their display ranges.
All the entries should be numbers with only one decimal point, and the
entries should be restricted to the length of the edit boxes.
Once the validity range is changed, the previous results will not be used in
the QC calculation as valid results, for example, if 20 valid samples are
needed for the X-B QC calculation, when you change the validity range after
10 groups of valid sample results have been acquired, these 10 groups of
results will be discarded, and only valid sample results generated
afterwards will be used in the QC calculation.
Click the “Print” button to print the setting information of the current QC file.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
After editing the X-B settings, the system will start the X-B run automatically.
After every 20-200 results (determined by the setting) are obtained, the system will perform the
X-B calculation once automatically. You can review the result in X-B graph or X-B table.
Graph
Table
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Graph Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the graph screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””X-B” on the pop-up menu.
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2. You can drag the scroll bar down to the graph horizontally to browse all the QC results.
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1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line
3- The QC points in each graph are displayed from left to right according to the sequence from
the earliest to the latest. The QC points are connected by a line to illustrate the distribution
trend.
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- The relative position of the QC point located on the green line and the total QC points saved
currently.
The value of the outlier is the X-B result of each batch of samples.
The outliers are excluded from the calculation of Mean, SD and CV%.
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You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to move the green line to the previous or the next
QC point; you can click the button or button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the
QC results of the QC points located on the green line under each parameter.
If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can
take the following steps to calculate and save the preset value for each parameter:
1. Click the “Calculate Preset Values” button, and then the screen displays two lines for
you to select the range for calculating the preset values.
2. Click and drag the two lines respectively to locate them at the beginning and the ending of
the range for calculating the preset values.
3. The Mean, SD and CV% (on the right of the graph) will change into the new results that
obtained by calculating within the selected range.
4. If you wish to save the new results, you can click the “Save Preset Values” button to save
the current Mean, SD and CV% as the preset values for the corresponding level
(high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV%
return to the calculated results of all QC results.
The calculation and display of the preset values are only available to the
parameter (within the calculation range) which has 3 or more than 3 results
within the limit. Otherwise, the display of the preset values will be empty.
Delete
1. If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.
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4. Click the “Ok” button and then confirm to delete the selected data.
Click the “Print” button to print all the file information and graphs of the parameters of the
current QC file.
The green line and the corresponding values of the QC points will not be
printed.
Table Review
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
1. You can enter the Table screen by one of the following ways:
Click the “Menu” button on the screen, and then select “QC””X-B” on the pop-up menu.
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3. You can drag the scroll bar down to the table horizontally to browse all the QC results.
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1- QC Result
2- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: The flag “H” or “L” will be used to prompt the result that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.
The value of the QC result is the X-B result of each batch of samples.
You can click the arrow button in the bottom of the screen to browse the QC result saved in the
current QC file.
You can click the button or button to highlight the previous or the next QC result;
you can click the button or button to highlight the first or the last QC result in the
table.
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Delete
1. If you wish to delete a single QC result, click the column contains the desired QC result; if
you wish to delete all the data, perform step 2 directly.
4. Click the “Ok” button and then confirm to delete the selected data.
1. Click the “Print” button, and then you can select “All Data” or “Specified Data” to be
printed.
2. Click the “All Data” button and then click the “Ok” button to print all the file information
and tables of the parameters of the current QC file; after clicking the “Specified Data”
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button, you can select the starting and finishing date (the saved date of the QC results) for
printing, then click the “Ok” button to print the specified data.
Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1. Click the “Communication” button, and then you can select “All Data” or “Specified
Data” to be transmitted.
2. Click the “All Data” button and then click the “Start” button to transmit the information of
the current QC file and QC data. After clicking the “Specified Data” button, you can
specify a date range (the date when the QC result was saved), then click the “Ok” button
to transmit the specified data. The “LIS/HIS connected” icon on the status bar of the
screen will flicker during transmission.
3. While transmitting, the “Start” button in the pop-up message box will be replaced by
“Stop”. You can click the “Stop”button to stop transmitting.
Data Backup
If you wish to backup the information and the result of the current QC file, do as follows:
1. Click the “Data Backup” button, a message box will pop up.
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2. Select the backup directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the backup data (the default name is [X-B_QC_date saved_time
saved]).
5. When the backup is finished, a message box will pop up, and then click “Ok” to exit.
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The backup data can not be modified. You can review the data in “History”
screen.
You can click the “Cancel” button to cancel backup when it is in process.
Be sure to backup data regularly.
Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1. Click the “Data Export” button, and then a message box will pop up.
2. Select the export directory (the default directory is the folder of “QC Data” under the
installation location of the terminal software).
3. Enter the name for the export data (the default name is [X-B_QC_date saved_time
saved]).
4. Select the format for the export file. (Default format: “. CSV”)
6. When the export is finished, a message box will pop up, and then click “Ok” to exit.
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You can modify the exported data but can not review the data in the
“History” screen.
You can click the “Cancel” button to cancel export when it is in process.
History
1. Click the “History” button, and then a message box will pop up.
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4. The display format and the function button are the same as the QC table screen. Browse,
print, transmit and export the data as instructed in the section of QC Table Review.
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9 Using the Calibration Programs
9.1 Introduction
Calibration is a procedure to standardize the analyzer by determining its deviation, if any, from
calibration references and to apply any necessary correction factors.
There are three calibration programs available on this analyzer: manual calibration, auto
calibration using calibrator and auto calibration using fresh blood samples.
All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be
calibrated by the calibration procedure.
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it is the first time this analyzer has been used (usually done by a Mindray-authorized
representative when installing the analyzer).
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1. Check and make sure enough reagents have been prepared for the calibration. You need
to start over the calibration if the reagents run out during the process.
2. Do the background check. If the analyzer alarms for abnormal background results, see
Chapter 12 Troubleshooting Your Analyzer for solutions.
Run a vial of normal control in the WB-CBC+DIFF mode for 11 consecutive times. Enter the
“Table” screen to check the reproducibility of the second to eleventh runs and make sure they
meet the following requirements.
Whole Blood Predilute
Parameter Condition Reproducibility Reproducibility
(CV%) (CV%)
9
WBC (4.0-15.0)×10 /L ≤ 2.0% ≤ 4.0%
12
RBC (3.50-6.00)×10 /L ≤ 1.5% ≤3.0%
HGB (110-180)g/L ≤ 1.5% ≤3.0%
MCV (70-120)fL ≤ 1.0% ≤2.0%
9
PLT (150-500)×10 /L ≤ 4.0% ≤8.0%
3. Run a vial of high control three consecutive times and then immediately run the diluent
three consecutive times. Calculate the carryover per the following equation.
The calculated carryovers shall meet the requirements in the following table.
Parameter Carryover
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
HCT ≤0.5%
PLT ≤1.0%
4. It is recommended that you create a log table for your analyzer. This log table should
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contain all necessary information that is pertinent to your analyzer. Suggested items that
you may want to include in the log table are: calibration date, supplier of calibrator, lot
number, expected results and limits, and result of background check.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.
You should only use the Mindray-specified controls and reagents. Store and
use the controls and reagents as instructed by instructions for use of the
controls and reagents.
Be sure to use the Mindray-specified disposable products including vacuum
collection tubes, anticoagulant collection tubes and capillary tubes etc.
1. Click “Menu”; select “Calibration” to enter “Calibration Factors” screen. The calibration
factors of whole blood mode and predilute mode are displayed at the “Calibration
Factors” screen.
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The login users of common-level can not perform the calibration procedures
but only browse the calibration factors at the current screen. To perform the
calibration, please logout and then re-login as users of administrator-level.
2. Enter the “Calibration Factors” screen to check the calibration factors and calculate the
new factors per the following equation.
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3. Enter the new calibration factors into the factor cell of the parameter that requires
calibration.
4. After the entry, click the “Save” button at the bottom of the screen. If the new calibration
factors are valid and different from the originals, a message box shown below will pop up.
Click “Yes” to save the news calibration factors and the calibration date of the corresponding
parameter changes to the current system date. Then, close the message box and return to the
“Calibration Factors” screen without any cell being highlighted.
If the new calibration factors are invalid, the message box will pop up.
Click “OK” to close the message box and the cell of the first invalid calibration factors is
highlighted with the data displayed.
5. After the calibration factors are modified, a prompt will show if you switch to another
screen without clicking the “Save” button.
If the entered calibration factors are valid, the message box will pop up when you exiting the
screen.
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Click “Yes” to save the news calibration factors and the calibration date of the corresponding
parameter changes to the current system date and be recorded in the history; then, close the
message box and switch to another screen.
If the entered calibration factors are invalid, the message box will pop up when you switching
to another the screen.
Click “Yes” to close the message box and switch to another screen without saving; keep the
original calibration factors and date.
Other operations
Restore
Click the “Restore” button to restore the calibration factors to the values displayed when you
entering the “Calibration Factors” screen.
If the calibration factors have not been changed, click the” Print” button to print the current
calibration factors.
If the changed calibration factors are invalid, then a message box will pop up when you clicking
the “Print” button.
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Click “OK”, then the cell of the first invalid calibration factors will be highlighted and the data in
the cell will not be cleared.
If the changed calibration factors are valid but have not been saved, then a message box will
pop up when you clicking the “Print” button.
Click “Yes” to close the message box and save the new calibration factors and date, and then
print the new calibration factors; click “No” to close the message box without saving the
calibration factors and date, and then print the saved calibration factors before editing.
1. Click the “Menu” button, and then select “Calibration” to enter the “Calibration Factors”
screen.
2. At the “Calibration Factors” screen, click the “Calibrator” tab to enter the “Calibrator”
screen.
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Using the Calibration Programs
Only in the whole blood mode can the calibration using calibrators be
performed.
The default “Exp. Date” is the current system date.
3. Enter the lot No. of the calibrator into the “Lot No.” box.
4. Enter the expiration date. The default “Exp. Date” is the current system date. You can
click the “Exp. Date” box, and then edit the date.
5. Select the parameter to be calibrated from the check box on the first line of the list.
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.
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Using the Calibration Programs
8. Click the “Start” button, and then a message box will pop up.
Press the aspirate key to start the calibration and the message box will close automatically,
and then a progress bar will pop up.
Once you click the “Start” button and press the aspirate key to start the first
run, the “Start” button will be displayed in gray. Then, you can directly press
the aspirate key to continue the calibration.
9. After every calibration run, the progress bar will close automatically and the analyzer will
have different responses according to different analysis results.
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Using the Calibration Programs
When the current running is done, if there is a parameter whose calibration data is out of its
linear range but still within the display range, then the calibration data will be displayed in the
list and a message box will also pop up.
Click “OK” to close the message box and delete the data from the table without saving.
When the running is done, if there is a parameter whose calibration data is out of the display
rage, then the non-numeric parameter values “***” will be displayed in the list and a message
box will pop up.
Click “OK” to close the message box and delete the data from the table without saving.
The valid results within the linear range will be displayed directly.
10. If the calibration factors have not been calculated but you switch to another screen, then a
message box will pop up.
Click “Yes” to switch to another screen while aborting the calibration data and closing the
message box. The original calibration factors remain.
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Using the Calibration Programs
11. When the amount of the valid calibrtion reaches N (N ≥6), the analyzer will automatically
calculate the mean, CV% and new calibration factors with all the selected data ( the first
data is excluded).
You can also select the desired data(5 at least) to calculate the calibration factors. Every time
when you select or de-select a data by clicking the check box, the calibration factors will be
refreshed immediately.
The out-of-range CV% does not influence the display of the calibration
factors.
When the amount of the valid calibration data in the list reaches 11, a
message box of “Calibrator calibration done!” will pop up. Then, if you
press the aspirate key again, the analyzer will beep and does not response.
12. There may be two cases when you switching to another screen:
If the calculated calibration factor of any parameter is out of the range [75%-125%] or the CV%
of any parameter exceeds the reproducibility standard, then the calculated calibration factors
of all parameters will not be saved and a message box will also pop up.
Click “Yes” to close the message box and switch to another screen without changing the
original calibration factors and the calibration date.
If the calculated calibration factors of all parameter are within the range [75%-125%] and the
CV% of all parameter are also within the reproducibility standard, then a message box will pop
up.
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Using the Calibration Programs
Click “Yes” to save the new calibration factors while closing the message box and switching to
another screen.
Other operations
If the calibration factors are invalid, then a message box will pop up when you clicking the
“Print” button.
Click “OK”, then the cell of the first invalid calibration factor will be highlighted and the data in
the cell will not be cleared.
If the calibration factors are valid, then a message box will pop up when you clicking the “Print”
button.
Click “Yes” to close the message box and save the calibration results and the calibration date,
and then print the contents of the current calibration screen; click “No” to close the message
box without saving.
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Using the Calibration Programs
2. At the “Calibration Factors” screen, click the “Fresh Blood” tab to enter the “Fresh
Blood” screen.
4. Run each of the prepared samples on the reference instrument (or by the reference
method) three times at least. Average the results for your reference values
5. Click the radio button “Whole Blood” or “Predilute” on the screen to select the desired
calibration mode.
If you run the sample in the “Predilute” mode and then switch to the “Whole
Blood” mode, the analyzer will switch the sequence automatically and a
progress bar will appear on the screen.
6. Select the sample ID of the current sample from the “Current sample ID” pull-down list.
7. Select the parameter to be calibrated from the check box on the first line of the list.
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9. Prepare the whole blood or predilute fresh blood sample ready for calibration.
10. Click the “Start” button; a message box will pop up.
Press the aspirate key to start the calibration and the message box will close automatically,
then a progress bar will pop up.
After you click the “Start” button and press the aspirate key to start the first
run, the “Start” button will display in gray. Then, you can press the aspirate
key to continue the calibration.
11. After the analysis, the calibration process indication will close automatically and the
analyzer will have different responses to different analysis results.
If the results are out of the linear range but still within the display range, the message box
will pop up at the same time the results are displayed in the table.
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Using the Calibration Programs
Click “OK” to close the message box and delete the results from the table without saving.
If the results are out of the display rage, the non-numeric parameter values “***” are
obtained and the message box will pop up.
Click “OK” to close the message box and delete the results from the table without saving.
The valid results within the linear range will be displayed directly.
12. When the amount of the valid calibration reaches N (N ≥6), the analyzer will calculate the
Mean, CV% and Calibration Factors of the data selected with “√” automatically (the first
data is excluded).
You can select several data to calculate the calibration factors, but only after 5 groups of
the data are selected at least can you get the calibration factors. Every time when you
select or cancel a data by selecting its check box, the calibration factors will be refreshed
and displayed immediately.
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Using the Calibration Programs
The out-of-range CV% does not influence the display of the calibration
factors.
When the amount of the valid calibration data in the table reaches 11, a
prompt of “Fresh blood calibration done!” will pop up; if you press the
aspirate key again, the analyzer will beep and does not response.
13. Select other calibration samples from the “Current sample ID” pull-down list, run the
samples as instructed in steps 8 to 12 to obtain the calibration factors of each sample.
14. There may be several cases when switching to another blood sample:
If the calibration factors of the blood sample are invalid or the CV% of any parameter
exceeds the reproducibility standard, a message box will pop up when you switching to
another blood sample.
Click “Yes” to empty the entered target of the current sample, all the calibration data
obtained and each calculated value including calibration factors, then close the message
box and switch to another blood sample.
If the calibration factors have not been calculated, the message box will pop up.
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Using the Calibration Programs
Click “Yes” to empty the entered target of the current sample and all the calibration data
obtained, then close the message box and switch to another blood sample.
If the calibration factors of the sample are valid and the CV% of all the parameters do not
exceed the reproducibility standard, you can switch to another blood sample directly.
15. After calibration factors of at least 3 fresh blood samples are obtained, click the
“Calculate” button to enter the screen of calibration calculation.
Select or cancel the calibration factors of a blood sample to calculate for the Mean calibration
factors by selecting the relevant check box.
When the selected calibration factors reaches 3 or more than 3, the CV% will be calculated
over again according to the selected calibration factors.
The exceeded CV% does not influence the display of the calibration factors.
When the selected calibration factors reaches 3 or more than 3, the mean calibration factors
will be calculated over again according to the selected calibration factors. If the deviation of the
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Using the Calibration Programs
calibration factor involved in the mean calibration factor calculation from the previous
calibration factor equals to or is greater than 5%, this calibration factor will be considered as
invalid, and the following message box will pop up when you try to exit the fresh blood
calibration screen.
Click "Yes" to close the message box, clear current calibration data, and switch to the
corresponding screen.
Click "No" to go back to the current screen. The invalid calibration factor(s) will be marked with
"?" and highlighted in red.
When the calculated mean calibration factor is invalid, you can perform
manual calibration at the calibration factor screen.
16. If the mean calibration factors have not been calculated, when you switch to the fresh
blood screen or switch to another calibration mode, a message box will pop up.
Click “Yes” to abort the calibration data and close the message box, switching to the
corresponding screen or other calibration mode. The original calibration factors and date
remain the same.
17. If the calculated mean calibration factors are valid, when you switch to the fresh blood
screen or switch to another calibration mode, a message box will pop up.
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Using the Calibration Programs
Click “Yes” to save the current mean calibration factors and refresh the calibration factors and
date in the table at the “Calibration Factors” screen. Then, you can switch to another screen
or calibration mode. Click “No” to close the message box and switch to another screen or
calibration mode without saving the mean calibration factors and all the calibration data.
Other operations
If the mean calibration factors are invalid, then a message box will pop up when you clicking
the “Print” button.
Click “OK”, then the cell of the first invalid calibration factor will be highlighted and the data in
the cell will not be cleared.
If the mean calibration factors are valid, click the “Print” button to print the following data in the
form of list, namely, the calibration factors of the sample in the “Calculated Result” table, the
results included in calculating the calibration factors and the mean calibration factors.
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Using the Calibration Programs
The history list displays the calibration information for the latest 80 calibrations; you can view
the contents in the list, but you are not allowed to modify or delete any content.
1. If the calibration mode of the selected record is “Adjust Manually”, the new calibration
factor and the original calibration factor are displayed in grey edit box.
2. If the calibration mode of the selected record is “Calibrator”, the new calibration factor, the
original calibration factor and all medium data are displayed in grey edit box.
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Using the Calibration Programs
The calibration data marked with “√” are used for calculation of calibration
factors.
3. If the calibration mode of the selected record is “Fresh Blood”, the calibration factor, mean
calibration factor and original calibration factor of each sample are displayed in grey edit box.
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Using the Calibration Programs
The calibration factors marked with “√” are used for calculation of mean
calibration factor.
If the calibration factor of a sample is displayed, you can click the “Detail…” button to display
all medium data.
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Using the Calibration Programs
Click “Close” to close the dialog box and return to the “History” screen.
The calibration data marked with “√” are used for calculation of sample
calibration factors.
Click the “Print” button down to the screen to print all calibration history records in table
format.
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10 Maintaining Your Analyzer
10.1 Introduction
Preventive and corrective maintenance procedures are required to keep the analyzer in a good
operating condition. This analyzer provides multiple maintenance functions for this purpose.
This chapter introduces how to use the provided functions to maintain and troubleshoot your
analyzer.
All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
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Maintaining Your Analyzer
10.2 Maintenance
At the “Motor” and “Valve” tabs of the “Self-test” screen and the “Status”
screen, the analyzer can not sleep.
If any influential error happens, the analyzer can not sleep.
Click the “Menu” button on the screen, then select “Shutdown””Sleep” on the pop-up menu.
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Maintaining Your Analyzer
After the preparation of sleep is complete, the progress bar closes automatically and the
analyzer enters the sleep status.
When the analyzer is sleeping, the analysis status icon at the screen
displays in red. The indicator on the analyzer displays in red at the time.
You can not run any sample when the analyzer is sleeping.
You can perform the operations without the cooperation of the analyzer
when it is sleeping, namely, communication and print etc.
If any error happens during the process of entering the sleep status, the
analyzer will not sleep but alarm for the error. See Chapter 11
Troubleshooting Your Analyzer for solutions.
Click the “Menu” button on the screen, then select “Shutdown””Cancel” on the pop-up
menu.
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Maintaining Your Analyzer
After the exiting is complete, the progress bar closes automatically and the analyzer exits the
sleep mode.
Aspirate Key
Press the aspirate key on the analyzer to exit the sleep mode
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Maintaining Your Analyzer
After the exiting is complete, the progress bar closes automatically and the analyzer exits the
sleep mode.
If any error happens during the process of exiting the sleep mode, see
Chapter 11 Troubleshooting Your Analyzer for details to remove the error.
After exiting the sleep mode successfully, the analyzer will return to the
certain status before sleeping. The analysis status icon at the screen
displays in green. The indicator on the analyzer displays in green at the
same time.
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
After installing a new container of reagent, keep it still for a while before
use.
When you have changed the diluent or lyses, run a background to see if the
results meet the requirement.
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Maintaining Your Analyzer
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
Click the “Replace Reagent” tab to enter the “Replace Reagent” screen
Diluent
LEO(I) lyse
LEO(II) lyse
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Maintaining Your Analyzer
LH lyse
Keep the diluent container from any strong vibration or collision with other
objects. Otherwise unreliable error messages may be reported.
While replacing the diluent container, be sure to follow the following steps: 1)
install the supporting board as shown below; 2) insert the cap assembly
(shown in the figure below) into the diluent container vertically, and then
secure the cap. Otherwise unreliable error messages may be reported.
1. Double click the icon of the desired reagent, and then enter the lot No. and expiration date
of the new reagent.
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Maintaining Your Analyzer
The check box “Change New Vial” should be selected if you wish to change
a container of reagent. Then, the edit box of “Lot No.” and “Exp. Date” will
be activated for you to enter the new lot No. and expiration date. When
finishing the replacement, the analyzer will save the new lot No. and
expiration date and then automatically modify the open-container expiration
date. The “Change New Vial” check box is selected as default.
The check box “Change New Vial” should not be selected if you only replace
the reagent in the container. Then, the edit box “Lot No.” and “Exp. Date”
will be unavailable. When finishing the replacement, the analyzer will not
modify the open-container expiration date.
The expiration date can not be empty.
1 to 16 digits can be entered into the box of “Lot No.” and an empty entry is
allowed.
After the “Use barcode scanner” is selected, you can enter the expiration
date of the reagents by the barcode scanner.
2. Click the “Replace” button to save the entered expiration date and lot No. and start
replacing.
3. After the replacing is complete, the following prompt will pop up.
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Maintaining Your Analyzer
10.2.4 Cleaning
You should clean the corresponding components under the following circumstances:
When the background of WBC and (or) HGB relative parameters exceeds the Ref. Range,
you should clean the WBC bath.
When the background of RBC and (or) PLT relative parameters exceeds the Ref. Range,
you should clean the RBC bath.
When the background of the scattergram has abnormal excessive cells, you should clean
the DIFF Bath.
When the background of the scattergram has abnormal excessive cells, or bad differential
of WBC, you should clean the flow cell.
When the sample probe is dirty, you should clean the sample probe.
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
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Maintaining Your Analyzer
WBC bath
RBC bath
DIFF bath
Flow cell
Sample probe
Do as follows to clean:
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Maintaining Your Analyzer
10.2.5 Unclogging
When clogging happens, you should perform the unclogging procedure.
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
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Maintaining Your Analyzer
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
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Maintaining Your Analyzer
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Maintaining Your Analyzer
pop-up menu.
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Maintaining Your Analyzer
When the problems including the background results exceeds the Ref. Range, bad differential
of scattergram and clogging still exist after other maintenances have been adopted.
If your analyzer is to run few samples, you should perform this procedure every two weeks.
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
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Maintaining Your Analyzer
1. Double click the icon of “Probe Cleanser Soak”, and then a message box will pop up.
2. Click “Yes”, and then the following progress bar will pop up and the analyzer is preparing
to soak.
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Maintaining Your Analyzer
3. After the preparation is done, the message box will pop up.
4. Perform the first aspiration of the cleanser as instructed. Then, the first-time priming
process starts automatically after the aspiration.
5. When the first-time priming is done, the progress bar closes automatically and the
following message box will pop up.
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Maintaining Your Analyzer
6. Aspirate the cleanser for the second time as instructed. Then, the second-time priming
process starts automatically when the aspiration is done.
7. When the priming is completed, the progress bar closes and a count-down box will pop up.
The soaking process starts.
8. The soaking process will last about 20 minutes. You may click the “Stop Soaking” button
in the message box to stop it. If you stop soaking in less than 5 minutes, the following
message box will pop up.
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Maintaining Your Analyzer
10. After the cleaning is completed, a message box will pop up.
12. Do the above procedures to perform the probe cleanser soak if necessary.
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Maintaining Your Analyzer
Take the following steps to perform the probe cleanser soak (DIFF bath):
1. Double click the “DIFF Bath Soaking” icon, and then a message box will pop up.
2. Click “Yes”, and then the progress bar shown below will pop up and the analyzer is
preparing.
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Maintaining Your Analyzer
4. After aspirating the probe cleanser as instructed, the following progress bar will pop up and
the analyzer starts priming automatically.
5. When the priming is complete, the progress bar closes and a count-down box will pop up.
The soaking process starts.
6. The soaking process will last about 20 minutes. You may click the “Stop Soaking” button in
the dialog box to stop it. If you stop soaking in less than 5 minutes, the following message box
will pop up.
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Maintaining Your Analyzer
Do the above procedures to perform the probe cleanser soaking for WBC bath and RBC bath if
necessary.
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
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Maintaining Your Analyzer
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Maintaining Your Analyzer
Then, click the “Maintain the whole device” tab to enter the screen.
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Maintaining Your Analyzer
1. Double click the icon of “Fluidics initialization”, and then a message box will pop up.
2. Click the “Yes” button to start initialization and “Fluidics initializing…” will be displayed in
the information area down to the screen.
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Maintaining Your Analyzer
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
Then, click the “Maintain the whole device” tab to enter the screen.
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Maintaining Your Analyzer
1. Double click the icon of “Clean Fluidics”, and then a message box will pop up.
2. Click the “Yes” button to start cleaning and “Fluidics cleaning…” will be displayed in the
information area down to the screen.
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Maintaining Your Analyzer
Click the “Menu” button on the screen, and then select “Service””Maintenance” on the
pop-up menu.
Then, click the “Maintain the whole device” tab to enter the screen.
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Maintaining Your Analyzer
1. Double click the icon of “Prepare to Ship”, and then a message box will pop up.
2. Click the “Yes” button to perform the procedure and a message box shown below will
display.
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Maintaining Your Analyzer
3. Remove all reagent pickup tube assemblies according to the prompt, and then click the
“Ok” button to start emptying the fluidic system.
5. Place all reagent pickup tube assemblies into the distilled water, and then click the “Ok”
button to start priming.
7. Remove all reagent pickup tube assemblies from the distilled water according to the
prompt, and then click “Ok” to start emptying the fluidic system.
8. After the emptying is complete, a message box will display. You should turn off the power
switch according to the prompt displayed on the screen.
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Maintaining Your Analyzer
After the prepared to ship procedure is done, you can still use the software.
10.2.14 Auto-cleaning
When the sample count times reach or over 100, the analyzer will perform the cleaning
procedure automatically once, and a prompt will be displayed on the screen.
Click “Yes”, and then the progress bar shown below will pop up and the analyzer is preparing.
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Maintaining Your Analyzer
After aspirating the probe cleanser for the first time as instructed, the following progress bar
will pop up and the analyzer starts the first-time priming automatically.
After the first-time priming is done, the progress bar closes and a message box will pop up.
After aspirating the probe cleanser for the second time as instructed, the following progress
bar will pop up and the analyzer starts the second-time priming automatically.
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Maintaining Your Analyzer
When the second-time priming is complete, the progress bar closes and a count-down box will
pop up. The soaking process starts.
The soaking process will last about 20 minutes. You may click the “Stop Soaking” button in
the dialog box to stop it after five minutes. The cleaning process starts after the soaking
progress is done.
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Maintaining Your Analyzer
At the “Self-test” or “Status” screen, the analyzer does not ask for
confirmation to perform the probe cleanser soak.
If the procedure of probe cleanser soaking is not started when it is
auto-prompted, the confirmation prompt will pop up again after 10 minutes.
10.2.16 Auto-sleeping
When the fluidics system stop working for 60 minutes (default), then the analyzer will enter
sleeping status automatically.
When the analyzer is in sleeping status, a prompt will display on the screen.
You can set the waiting time for auto-sleeping, see chapter 5 Customizing
the Analyzer Software for details.
At the “Self-test” or “Status” screen, the analyzer can not sleep.
If it is the time to auto-sleep but the analyzer is error status, then only after
the error is removed will the auto-sleeping starts accordingly.
You can perform the operations without the cooperation of the analyzer
when it is sleeping, namely, communication and print etc.
10.2.17 Sterilization
The user shall perform daily cleaning and sterilization to the cover of the analyzer. Use the
specified materials to sterilize the equipment only. For damage or accident caused by using
other materials, Mindray will not provide any guarantee.
Mindray bears no responsibility of the validity of the listed chemicals as the infection control
solution. For the methods to control infection, please consult the Infection Prevention
Department of the hospital or the epidemic experts.
The sterilization may damage the analyzer to some extent. It is recommended to perform
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Maintaining Your Analyzer
sterilization only necessary in your hospital service plan. Clean the equipment before
sterilizing.
Recommended disinfectant: 70% ethanol, 70% isopropyl alcohol and Cidex 2% Glutaral +
Activator.
Prohibited disinfectant: 3% hydrogen peroxide, Aerodesin 2000, Cidex OPA.
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Maintaining Your Analyzer
If the results of the status testing exceed the normal range, they will be
highlighted by the red background.
Then, click the “Temperature&Pressure” tab and a message box will pop up.
When the sequence is complete, the message box closes automatically and you will enter the
following screen.
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Maintaining Your Analyzer
You can check the information about the temperature and pressure, and also export or print
the information.
Export
1. Click the “Export” button at the bottom of the screen and then select the desired
information from the pop-up message box.
2. Click the “Browse” button, and then a message box will pop up.
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Maintaining Your Analyzer
3. Select the directory and format for the exported file and enter the file name.
4. Click the “Save” button to save the selected information to the specified location.
If the exporting failed, you should click the “Ok” button and then try again or
change another exporting directory; if it does not help, please contact
Mindray customer service department or your local distributor.
The default format of the exported information is “.txt” and you can also
choose the “.csv” format.
1. Click the “Print” button at the bottom of the screen and then select the desired information
from the pop-up message box.
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Maintaining Your Analyzer
The user of common level can not see the “Analyzer Information” option in
the “Print” message box. If you wish to print the analyzer information,
please log out and then log in as user of administrator level.
Click the “Menu” button on the screen, and then select “Service””Status” on the pop-up
menu.
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Maintaining Your Analyzer
You can check the information about the voltage and current, and also export or print the
information.
Export
1. Click the “Export” button at the bottom of the screen and then select the desired
information from the pop-up message box.
2. Click the “Browse” button, and then a message box will pop up.
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Maintaining Your Analyzer
3. Select the directory and format for the exported file and enter the file name.
4. Click the “Save” button to save the selected information to the specified location.
If the exporting failed, you should click the “Ok” button and then try again or
change another exporting directory; if it does not help, please contact
Mindray customer service department or your local distributor.
The default format of the exported information is “.txt”, and you can also
choose the “.csv” format.
1. Click the “Print” button at the bottom of the screen and then select the desired information
from the pop-up message box.
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Maintaining Your Analyzer
The user of common level can not see the “Analyzer Information” option in
the “Print” message box. If you wish to print the analyzer information,
please log out and then log in as user of administrator level.
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Maintaining Your Analyzer
You can check the information about the version and configuration, and export or print them.
Export
1. Click the “Export” button, and then the following message box will pop up
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Maintaining Your Analyzer
2. Select the directory and format for the exported file and enter the file name.
3. Click the “Save” button to save the selected information to the specified location.
If the exporting failed, you should click the “Ok” button and then try again or
change another exporting directory; if it does not help, please contact
Mindray customer service department or your local distributor.
The default format of the exported information is “.txt” and you can also
choose the “.cvs” format.
Click the “Print” button at the bottom of the screen to print the information.
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Maintaining Your Analyzer
10.5 Self-test
Then, click the “Sampling Mechanism Assembly Self-test” tab to enter the following screen.
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Maintaining Your Analyzer
You can check the status of all items and print the results.
Self-test
When the self-testing is finished, a message box will pop up to inform you the normal testing
results. Then, click the “Ok” button to close the message box.
If the testing result is abnormal, you should click the “Ok” button and try
again for several times; if it does not help, please contact Mindray customer
service department or your local distributor.
Click the “Print” button at the bottom of the screen to print the latest testing results (normal/
abnormal) of all items.
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Maintaining Your Analyzer
10.5.2 Valve
Click the “Menu” button on the screen, and then select “Service””Self-test” on the pop-up
menu.
Single valve
Click the desired Valve No. (e.g. “1”), then identify whether it works well by judging its sound
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Maintaining Your Analyzer
All valves
After clicking the “All Valves” button, all valves will be tested according to their No. one by one.
A progress bar will pop up at the same time.
Whether the valve works well or not is identified by judging its sound when
opening and closing
The current status (open/close) of all valves is displayed in the “Status” box
of the screen. When testing the valves, they open first and then close.
You can click the “Cancel” button on the progress bar to stop the testing for
all valves.
10.5.3 Others
Click the “Menu” button on the screen, and then select “Service””Self-test” on the pop-up
menu.
10-48
Maintaining Your Analyzer
You can check the status of all above items and print the results.
Self-test
When the self-testing is finished, a message box will pop up to inform you the testing result.
Then, you can click the “Ok” button to close the message box.
10-49
Maintaining Your Analyzer
If the testing result is abnormal, you should click the “Ok” button and try
again for several times; if it does not help, please contact Mindray customer
service department or your local distributor.
Click the “Print” button at the button of the screen to print the latest testing results (normal/
abnormal) of the items.
10-50
Maintaining Your Analyzer
10.6 Counter
Click the “Menu” button on the screen, and then select “Service””Counter” on the pop-up
menu.
You can check the statistic information of all the above items and the detail statistic information
of some items.
10-51
Maintaining Your Analyzer
You can check the detail information for the sample count times, QC times and calibration
times.
You can click the “Detail…” button next to the “Sample Count Times” to display the detail
statistic information about the sample count times.
You can click the “Detail…” button next to the “QC Times” to display the detail statistic
information about the QC times.
You can click the “Detail…” button next to the “Calibration Times” to display the detail statistic
10-52
Maintaining Your Analyzer
Click the “Print” button at the bottom of the screen to print all the statistic information of the
current screen.
10-53
Maintaining Your Analyzer
10.7 Log
If you add a new record when the log is full, the newest record will overwrite
the oldest automatically.
Up to records of one year can be saved in the log.
Up to 100 characters can be entered for remarks.
Then, click the “Set Paras” tab to enter the following screen.
10-54
Maintaining Your Analyzer
You can check the log information, enter remark information and also export and print the
information.
Remark
1. Enter the remark information in the “Remark” box of the desired log record.
2. Click the “Save” button at the bottom of the screen to save the remarks.
Click the “Print” button at the bottom of the screen. You can select “Date Range” or “No.
Range” to determine the print range.
10-55
Maintaining Your Analyzer
1) Enter the starting date and finishing date of the records you want to print.
1) Enter the starting date and finishing No. of the log you want to print.
Detail
Click the “Detail…” button to check the details of the highlighted record.
10-56
Maintaining Your Analyzer
Then, click the “Other Logs” tab to enter the following screen.
You can check the log information, enter remark information and also export and print the
information.
Remark
1. Enter the remark information in the “Remark” box of the desired log record.
2. Click the “Save” button at the bottom of the screen to save the remark.
10-57
Maintaining Your Analyzer
Click the “Print” button at the bottom of the screen. You can select “Date Range” or “No.
Range” to determine the print range.
1) Enter the starting date and finishing date of the records you want to print.
1) Enter the starting date and finishing No. of the log you want to print.
Detail
Click the “Detail…” button to check the details of the highlighted record.
10-58
Maintaining Your Analyzer
Click the “Menu” button on the screen, and then select “Service””Log” on the pop-up menu.
Then, click the “Error Info.” tab to enter the following screen.
You can check the log information, enter remark information and also export and print the
10-59
Maintaining Your Analyzer
information.
Remark
1. Enter the remark information in the “Remark” box of the desired log record.
2. Click the “Save” button at the bottom of the screen to save the remark.
Click the “Print” button at the bottom of the screen. You can select “Date Range” or “No.
Range” to determine the print range.
1) Enter the starting date and finishing date of the records you want to print.
1) Enter the starting date and finishing No. of the log you want to print.
Detail
Click the “Detail…” button to check the details of the highlighted record.
10-60
Maintaining Your Analyzer
The “All Logs” tab displays all the available log information for the current
user.
Click the “Menu” button on the screen, and then select “Service””Log” on the pop-up menu.
Then, click the “All Logs” tab to enter the following screen.
You can check the log information, enter remark information and also export and print the
10-61
Maintaining Your Analyzer
information.
Remark
1. Enter the remark information in the “Remark” box of the desired log record.
2. Click the “Save” button at the bottom of the screen to save the remark.
Click the “Print” button at the bottom of the screen. You can select “Date Range” or “No.
Range” to determine the print range.
1) Enter the starting date and finishing date of the records you want to print.
1) Enter the starting date and finishing No. of the log you want to print.
Detail
Click the “Detail…” button to check the details of the highlighted record.
10-62
11 Troubleshooting Your Analyzer
11.1 Introduction
This chapter contains information that is helpful in locating and correcting problems that may
occur during operation of your analyzer.
11-1
Troubleshooting Your Analyzer
The red error message means that the analyzer will terminate the current action
immediately and you can not perform any operation.
The orange error message means that the analyzer will terminate the current action
immediately.
The blue error message means that the analyzer can still proceed with the current action,
but other operations related to the error(s) of this kind will be restricted.
The green error message means that the analyzer can still proceed with the current action
and other operations will not be restricted.
You can see the error name(s) and the corresponding troubleshooting information in the
pop-up message box. The error names are displayed in order.
You can click the error name in the message box to select (highlight) it and check the
corresponding troubleshooting information in the “Troubleshooting” list under the message box.
The troubleshooting information of the first error will display (default). Follow the instructions in
the message box to remove the error(s)
11-2
Troubleshooting Your Analyzer
Remove Error
Click the “Remove error” button, then the system will remove the error automatically if
possible. If the error(s) still exists, you should follow the instructions of the troubleshooting to
remove the error(s).
Silent
Click the “Close” button to close the “Error” message box, but the corresponding error
message will display in the error message area. If you click the error message again, the “Error”
message box will be re-opened.
The possible error(s) and the corresponding troubleshooting information are listed below:
11-3
Troubleshooting Your Analyzer
11-4
Troubleshooting Your Analyzer
settings screen will pop up. Set the reagent expiration date
as instructed in Chapter 5 Customizing the Analyzer
Software, and then click “Ok”.
3. Click the “Remove error” button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department.
Diluent expired 1. Check if the diluent is expired. If so, change a new
container of diluent.
2. Click the “Remove error” button, and then the “Reagent”
settings screen will pop up. Set the reagent expiration date
as instructed in Chapter 5 Customizing the Analyzer
Software, and then click “Ok”.
3. Click the “Remove error” button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department.
LH Lyse expired 1. Check if the LH Lyse is expired. If so, change a new
container of lyse.
2. Click the “Remove error” button, and then the “Reagent”
settings screen will pop up. Set the reagent expiration date
as instructed in Chapter 5 Customizing the Analyzer
Software, and then click “Ok”.
3. Click the “Remove error” button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department.
No Diluent 1. Check whether the diluent container is empty.
2. If there is no diluent, install a new container of diluent.
Then click the “Remove error” button to prime the analyzer
with the diluent.
3. Enter “Reagent” settings to modify the reagent
expiration date as instructed in Chapter 5 Customizing
the Analyzer Software.
4. If there is still plenty of diluent, or if the error still exists
after a new container of diluent is installed, contact our
customer service department.
No LH lyse 1. Check whether the LH lyse container is empty.
2. If there is no LH lyse, change a new container of LH
lyse. Then click the “Remove error” button to prime the
11-5
Troubleshooting Your Analyzer
11-6
Troubleshooting Your Analyzer
11-7
12 Customizing the Print Template
12.1 Introduction
You can modify the print template based on the default one provided by the software in order
to customize the format of the report.
After customizing and saving a template, you can select the newly customized one in the print
setup. And then, the report will be printed in the customized template.
12-1
Customizing the Print Template
1. Click the “Customize” button to enter the “PrintTemplate” screen, and the following
message box will pop up.
2. Enter the correct user name and password in the message box, and go to the print template
screen shown as follows.
12-2
Customizing the Print Template
12-3
Customizing the Print Template
Click on the "Report" tab in the "ProjectProperty" area to display all existing templates in
the current template library. Click one of the template names and the corresponding
template will be displayed in the working area.
Click "File" "Open" on the menu bar or the button on the toolbar, and then
specify the directory and select the template file. Click "Open" to open the template.
You can click the button (line control) to draw a straight line or an oblique line in the
working area.
You can click the button (title control) to add a title in the working area.
You can click the button (label control) to add the fixed text information in the working
area.
You can click the button (edit control) to add details associated with the print template
and the changeable information in the working area.
You can click the button (picture control) to arrange the location and size of the graph
in the working area.
You can click the button (table control) to add a table in the working area.
Inserting a Business
A business is a set of controls which can be inserted in the template to facilitate the editing
12-4
Customizing the Print Template
1. Click "Insert" on the menu bar and choose "Head", "Body" or "Tail". The following message
box will pop up.
2. Select the desired business name in the pull-down list. Click the "Ok" button to close the
message box and insert the selected business.
Press and hold the "Ctrl" key on the keyboard, and at the same time, click on the controls
you want to select.
Click on the template in the working area and drag the mouse to enclose the controls you
want to select in the rectangular box displayed.
Select the control(s) you want to move. Left click and hold the mouse, and then move the
control to the destination and release.
Select the control(s) you want to move. Press and hold the "Ctrl" key, and move the
control using the arrow keys on the keyboard.
12-5
Customizing the Print Template
12-6
Customizing the Print Template
1. On the menu bar, click "File" "Import", and the following message box will pop up.
2. Choose the import type and click "Ok". Then the following message box will pop up.
3. Select the template file you want to import and click "Open" to import the template into the
current library. The name of the imported template will be displayed under the "Report" tab,
shown as follows.
12-7
Customizing the Print Template
2. Double click the template you want to export to open it in the working area.
3. On the menu bar, click "File" "Export", and the following message box will pop up.
12-8
Customizing the Print Template
4. Specify the directory you want to save the template and enter the file name. Click "Save" to
save the template.
Click "File" "Preview" on the menu bar or the button on the toolbar to preview the
current template.
Click "File" "Print" on the menu bar or the button on the toolbar to print the current
template.
Click "File" "Delete" on the menu bar or the button on the toolbar to delete the
current template.
12-9
Customizing the Print Template
3. Click "Business" "Save" on the menu bar, and the following message box will pop up.
Enter the information of the business in corresponding boxes and click "Ok" to save the
business.
2. Select the right machine model and click "Ok" to load the template library for this model.
3. When the loading is completed, all the templates in the loaded library will be displayed
under the "Report" tab.
12-10
13 Appendices
A Index
analyzer network, 11-7
intended, 2-2 optical, 11-4
name, 2-1 sample, 11-3
Aspiration, 3-2 syringe, 11-3
Auto, 9-8, 9-13 voltage, 11-3
Background, 11-7 flags, 6-20
barcode, 5-5
Flow, 3-5
Bas#
Flushing, 10-13
definition, 3-7
HCT
formula, 3-7
formula, 3-11
Bas%
Help, 2-25
definition, 3-7
HGB
formula, 3-7
formula, 3-9
calibration
measurement, 3-9
conditions, 9-2
History
introduction, 9-1
L--J, 8-46
manual, 9-4
X, 8-94
calibrators, 2-29
X--B, 8-150
Carryover, B-4
X--R, 8-125
Cleaning, 10-9
Initialization, 6-4
controls, 2-29
Installation, 4-2
CV, 7-25 Laser, 1-14, 11-6
Date, 5-2 LEO, 2-28
Derivation, 3-7 LEO(I), 11-4
DIFF, 3-6, 11-4 LEO(II), 11-4
Diluent, 2-28, 11-5 LH, 2-28, 11-5
Dilution, 3-3 Lym#
Directory, 2-23 definition, 3-8
Electrical, 3-6 formula, 3-8
Eos# Lym%
definition, 3-8 definition, 3-7
formula, 3-8 formula, 3-7
Eos% Main, 2-4
definition, 3-8 Maintenance, 10-2
formula, 3-8 Manual, 10-2
error MCH
drive, 11-3 formula, 3-11
error, 11-2 MCHC
A-1
Appendices
A-2
Appendices
A-3
B Specifications
B.1 Classification
According to the CE classification, the BC-5300 belongs to In vitro diagnostic medical devices
other than those covered by Annex II and devices for performance evaluation.
B.2 Reagents
M-53 Diluent M-53D Diluent
M-53 Lyse M-53LEO(I) Lyse
M-53LEO(II) Lyse
M-53LH Lyse
Cleanser M-53P Probe Cleanser
B.3 Parameters
Parameter Abbreviation Default Unit
9
White Blood Cell count WBC 10 /L
9
Neutrophils number Neu# 10 /L
9
Lymphocytes number Lym# 10 /L
9
Monocytes number Mon# 10 /L
9
Eosinophils number Eos# 10 /L
9
Basophils number Bas# 10 /L
9
Abnormal Lymphocytes number ALY# (RUO) 10 /L
9
Large Immature Cells number LIC# (RUO) 10 /L
Neutrophils percentage Neu% %
Lymphocytes percentage Lym% %
Monocytes percentage Mon% %
Eosinophils percentage Eos% %
Basophils percentage Bas% %
Abnormal Lymphocytes percentage ALY% (RUO) %
Large Immature Cells percentage LIC% (RUO) %
12
Red Blood Cell count RBC 10 /L
Hemoglobin Concentration HGB g/L
Hematocrit HCT %
Mean Corpuscular Volume MCV fL
Mean Corpuscular Hemoglobin MCH pg
B-1
Appendices
B.4.2 Throughput
Whole Blood Mode ≥ 60 samples/ 1 hour
Predilute Mode ≥ 50 samples/ 1 hour
B-2
Appendices
9
PLT 0-2000×10 /L
HCT 0%-80%
B.5.4 Reproducibility
These reproducibility requirements apply only to the situation in which a qualified sample has
nd th
been run for 11 times and the results of the 2 to 11 runs are used to calculate the
reproducibilities.
Parameter Condition Whole Blood Predilute
Reproducibility(CV% / Reproducibility(CV% /
absolute deviation d※) absolute deviation d※)
9
WBC (4.0-15.0)×10 /L ≤2.0% ≤4.0%
Neu% 50.0%-60.0% ±4.0(absolute deviation) ±8.0(absolute deviation)
Lym% 25.0%-35.0% ±3.0(absolute deviation) ±6.0(absolute deviation)
Mon% 5.0%-10.0% ±2.0(absolute deviation) ±4.0(absolute deviation)
Eos% 2.0%-5.0% ±1.5(absolute deviation) ±2.5(absolute deviation)
Bas% 0.5%-1.5% ±0.8(absolute deviation) ±1.2(absolute deviation)
12
RBC (3.50-6.00)×10 /L ≤1.5% ≤3.0%
HGB (110-180) g/L ≤1.5% ≤3.0%
MCV (70-120) fL ≤1.0% ≤2.0%
B-3
Appendices
9
PLT (150-500)×10 /L ≤4.0% ≤8.0%
MPV / ≤4.0% ≤8.0%
※:Absolute deviation d = analysis result – average of analysis results
B.5.5 Carryover
Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 0.6 %
HCT ≤ 0.5 %
PLT ≤ 1.0 %
RAM: ≥256 MB
B-4
Appendices
B.6.2 Keyboard
101-Key alpha-numeric keyboard
B.6.3 Mouse
B.6.5 Printer
B.7 Interfaces
One LAN interface
NOTE
Main supply voltage fluctuations up to ±10% of the nominal voltage.
This equipment complies with the emission and immunity requirements of the EN
61326-1:2006 and EN 61326-2-6:2006.
B-5
Appendices
This equipment has been designed and tested to CISPR11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
NOTE
It is the manufacturer's responsibility to provide equipment electromagnetic
compatibility information to the customer or user.
It is the user's responsibility to ensure that a compatible electromagnetic
environment for the equipment can be maintained in order that the device
will perform as intended.
B.10 Sound
Maximal sound: 66.2dBA
Relative humidity: 10 % - 90 %
Relative humidity: 10 % - 90 %
B-6
Appendices
Height
Depth
Width
Analyzer
Width(mm) ≤410
Height(mm) ≤530
Depth(mm) ≤470
Weight(Kg) ≤45
B.15 Contraindications
None
B-7
C Communication
C.1 Introduction of communication protocol of the auto
hematology analyzers
Connecting
After starting up, the IPU software connects the LIS server actively according to the settings. If
the connecting is failed, it retries; if the connecting is successful, it keeps the connection to
make sure the data can be sent at any time. If the connection is found disconnected during
operating, it retries to connect.
Data transmitting
Besides batch sending the data at the List Review and QC screen, if auto-communication is
enabled, the IPU software will send the message while the new sample results are obtained.
Sending and receiving the message are synchronous both for batch communication and
auto-communication. i.e. when every message is sent, it will wait for the confirmation. If the
confirmation is received within 10s, then a complete message is sent and the next message
will be sent; if the confirmation is not received within the 10s, then it is regarded that the
sending is failed and it will skip to the sending of the next message.
The communication of QC data records is similar to that of the analysis results: send
messages at the QC screen or QC History screen. Wait for the confirmation after sending each
QC data. If the confirmation is received within 10s, then the message has been sent
successfully; if the confirmation is not received within 10s, then it is regarded that the sending
is failed and it will skip to the sending of the next message.
The bidirectional LIS inquiry communication is different from the processes mentioned above.
The IPU software will send an inquiry (including the sample ID) every time it opens the
C-1
Appendices
bidirectional LIS communication, saves worklists or before counting. The LIS will respond with
a HL7 message based on the message it received, and then IPU will fill in the worklist or
perform counting according to the response. If there is no response within 10s after the inquiry
was sent, it is regarded that the inquiry is failed.
Disconnecting
When exiting the IPU software, the connection will be closed actively. When changing the
communication settings, the connection will also be disconnected and then re-connect
according to the new settings.
MSH|^~\&|BC-5300|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
PID|1||7393670^^^^MR||Joan^JIang||19900804000000|Female
C-2
Appendices
PV1|1||nk^^001
OBR|1||20071207011|00001^Automated
Count^99MRC||20080508140600|20080508150616|||John||||20080508150000||||||||||HM||||||||
Mindray
OBX|1|IS|08001^Take Mode^99MRC||O||||||F
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC||||||F
OBX|4|IS|01002^Ref Group^99MRC||Woman||||||F
……
Every HL7 message consists of several segments and ends up with the <CR> character.
C-3
Appendices
Each segment consists of the segment name of three characters and field of changeable
characters, and each field consists of the component and subcomponent. For each message,
the separators of the field, component and subcomponent are defined in the MSH segment.
For example:
MSH|^~\&|BC-5300|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
In this message:
The five characters following MSH define the separators to distinguish each field, component
and subcomponent. Although they can be any non-text characters, HL7 standard recommends
the characters in the table below:
Character Meaning
| Field separator
^ Component separator
& Subcomponent separator
~ Repetition separator
\ ESC
The first field of MSH includes every separator. Some field behind are empty because they are
optional and not used by Mindray HL7 interface. Detailed field definition and selection will be
stated in the following contents.
For message of any type, the segments behind MSH appear in the fixed order. The order will
be described in the following contents and the grammar is used to organize the segments
order.
The segment appeared in [] is optional.
The segment appeared in {} can be repeated once or more.
C-4
Appendices
All the data information can be expressed by different types of HL7 fields. Only part of the HL7
standard is used in the communication protocol, see D4 Appendix for details.
1. The main unit directly sends the test results (or QC data) to LIS as Figure 2 shows.
C-5
Appendices
ORM^O01 message: Common order message, all the actions related to order basically use
the message of this type. For example, create a new order or cancel an order. Here, the main
unit requests LIS to re-fill the order message.
ORM General Order Message Description
MSH Message header
{ORC} Common message of Order, including the No. information of the sample searched
ORR^O02 message: affirming of the ORM^O01 message. Here, returning the completed
information of order (i.e. worklist).
ORR^O02 General Order Response Message Description
MSH Message header
MSAMessage affirm
[PIDPatient basic information
[PV1]]Patient visit information
{
ORCCommon message of Order, including the sample No.
[
OBRsample information
{[OBX]}Data of other sample information, including work mode, etc.
]
}
C-6
Appendices
MSH
The MSH(Message Header)segment contains basic information of HL7 message including
separators’ value, message type and coding method etc. It is the first field of every HL7
message.
Message used for example:
MSH|^~\&|BC-5300|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
See Table 1 for definition of each field used in MSH segment.
Table 1 MSH field definitions
No Field Dat Recommende Note Samples
. Name a d max length
type
1 Field ST 1 Includes the separator of the |
Separator first field after the segment
name; be used to determine
the separator’s value of the
rest parts of the message.
2 Encoding ST 4 Includes component ^~\&
Character separators, repetition
s separators, transferred
C-7
Appendices
separators and
subcomponent separators;
the value in the HL7 message
of auto hematology analyzers
is “^~\&”
3 Sending EI 180 Application program of BC-5300
application sending terminal. If the main
unit sends the message; the
value is “BC-5300” or
“BC-5380”.
4 Sending EI 180 Device of sending terminal. If Mindray
Facility the main unit sends the
message, the value is
“Mindray”.
7 Date/Time TS 26 Created time of message (in 2008061714394
Of the format of 3
Message YYYY[MM[DD[HH[MM[SS]]]]]
); adopts the system time.
9 Message CM 7 Message type; in the format ORU^R01
Type of “message type^event
type”. e.g. ORU^R01
10 Message ST 20 Message control ID; be used 1
Control ID to mark a message uniquely.
11 Processin PT 3 Message processing ID P
g ID values:
“P”- sample and worklist
searching information;
“D”- QC setup information;
“T” – QC results information;
In Ack messages, it is
consistent with the previously
received message.
12 Version ID VID 60 HL7 version information; the 2.3.1
value is “2.3.1”.
18 Character ID 10 Character set. UNICODE
Set The value is “UNICODE”, and
the message is expressed by
Unicode string.
C-8
Appendices
MSA
The MSA(Message Acknowledgement) segment contains message confirming information.
Message used for example:
MSA|AA|1
See Table 2 for definition of the fields used.
Table 2 MSA field definitions
No. Field Name Data Recommended Note Samples
type max length
1 Acknowledgment ID 2 Acknowledgement code: AA
Code “AA”- receive, “AE” – error,
“AR”- reject
2 Message Control ST 20 Message control ID; it’s 1
ID consistent with the MSH-10
of the received message.
6 Error Condition CE 100 Error condition (status
code); it also contains error
condition specification
information; see Table 3 for
the value.
C-9
Appendices
PID
The PID(Patient Identification) segment contains the patient basic information.
Message used for example:
PID|1||7393670^^^^MR||Joan^JIang||19900804000000|Female
See Table 4 for definition of the fields used.
C-10
Appendices
PV1
The PV1(Patient Visit) segment contains the patient visit information.
Message used for example:
PV1|1||nk^^001
See Table 5 for definition of the fields used.
OBR
The OBR(Observation Request) segment contains the test report information.
Message used for example:
OBR|1||20071207011|00001^Automated Count^99MRC||20080508140600|20080508150616
|||John||||20080508150000||||||||||HM||||||||Mindray
See Table 6 for definition of the fields used.
C-11
Appendices
searching
response, i.e.
ORC^O02
3 Filler Order EI 22 To be used as 20071207011
Number + sample ID in the
message of test
results
To be used as file
No. in the QC
message
4 Universal CE 200 Universal service 00001^Automated
Service ID ID, to identify Count^99MRC
different types of
test results. See
Appendix B for
detailed values.
6 Requested TS 26 Requested 20080508140600
Date/time Date/time
To express the
sampling date and
time.
7 Observation TS 26 Run Time 20080508150616
Date/Time #
10 Collector XCN 60 Sample collector John
Identifier * To indicate the
deliverer
13 Relevant ST 300 Relevant clinical
Clinical Info. information.
It can be used as
the clinical
diagnostic
information in the
patient info.
14 Specimen TS 26 Sample received 20080508150000
Received time
Date/Time * To express the
delivery time.
15 Specimen CM 300 Sample source
Source * Its value in HL7
message on the
C-12
Appendices
auto hematology
analyzers:
“BLDV”- Venous
blood
“BLDC”- Capillary
blood
22 Results TS 26 Results
Rpt/Status report/Status
Chng - Change -
Date/Time + Date/Time
To be used as
validating time.
24 Diagnostic ID 10 Diagnostic ID, the HM
Serv Sect ID value is “HM”,
means Hematology.
28 Result Copies XCN 60 Result copies to
To To indicate the
validater.
32 Principal CM 200 Principal result Mindray
Result interpreter
Interpreter + To be used as
tester in the sample
message
To be used as “set
by” in the QC
message
To be used as
“Operator” in the
QC run message
OBX
The OBX(Observation/Result) segment contains the parameter information of each test result.
Message used for example:
OBX|6|NM|6690-2^WBC^LN||9.81|10*9/L|4.00-10.00|N|||F||E
See Table 7 for definition of the fields used.
C-13
Appendices
C-14
Appendices
ORC
The ORC(Common Order) segment contains the common information of order.
Message used for example:
ORC|RF||SampleID||IP
See Table 8 for definition of the fields used.
C-15
Appendices
Sample message
MSH|^~\&|BC-5300|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
PID|1||7393670^^^^MR||Joan^JIang||19900804000000|Female
PV1|1||nk^^001
OBR|1||20071207011|00001^Automated
Count^99MRC||20080508140600|20080508150616|||John||||20080508150000||||||||||HM||||||||
Mindray
OBX|1|IS|08001^Take Mode^99MRC||O||||||F
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC||||||F
C-16
Appendices
OBX|4|IS|01002^Ref Group^99MRC||Woman||||||F
OBX|5|NM|30525-0^Age^LN||18|yr|||||F
OBX|6|NM|6690-2^WBC^LN||9.81|10*9/L|4.00-10.00|N|||F||E
OBX|7|NM|704-7^BAS#^LN|||10*9/L|0.00-0.10||||F
OBX|8|NM|706-2^BAS%^LN||||0.000-0.010||||F
OBX|9|NM|751-8^NEU#^LN|||10*9/L|2.00-7.00||||F
OBX|10|NM|770-8^NEU%^LN||||0.500-0.700||||F
OBX|11|NM|711-2^EOS#^LN|||10*9/L|0.02-0.50||||F
OBX|12|NM|713-8^EOS%^LN||||0.005-0.050||||F
OBX|13|NM|731-0^LYM#^LN|||10*9/L|0.80-4.00||||F
OBX|14|NM|736-9^LYM%^LN||||0.200-0.400||||F
OBX|15|NM|742-7^MON#^LN|||10*9/L|0.12-0.80||||F
OBX|16|NM|5905-5^MON%^LN||||0.030-0.080||||F
OBX|17|NM|26477-0^*ALY#^LN|||10*9/L|0.00-0.20||||F
OBX|18|NM|13046-8^*ALY%^LN||||0.000-0.020||||F
OBX|19|NM|10000^*LIC#^99MRC|||10*9/L|0.00-0.20||||F
OBX|20|NM|10001^*LIC%^99MRC||||0.000-0.025||||F
OBX|21|NM|789-8^RBC^LN||4.53|10*12/L|3.50-5.00|N|||F
OBX|22|NM|718-7^HGB^LN||65|g/L|110-150|L|||F
OBX|23|NM|787-2^MCV^LN||89.5|fL|80.0-100.0|N|||F
OBX|24|NM|785-6^MCH^LN||14.4|pg|27.0-31.0|L|||F
OBX|25|NM|786-4^MCHC^LN||160|g/L|320-360|L|||F
OBX|26|NM|788-0^RDW-CV^LN||0.133||0.115-0.145|N|||F
OBX|27|NM|21000-5^RDW-SD^LN||50.9|fL|35.0-56.0|N|||F
OBX|28|NM|4544-3^HCT^LN||0.405||0.370-0.480|N|||F
OBX|29|NM|777-3^PLT^LN||212|10*9/L|100-300|N|||F
OBX|30|NM|32623-1^MPV^LN||6.6|fL|7.0-11.0|L|||F
OBX|31|NM|32207-3^PDW^LN||15.4||15.0-17.0|N|||F
OBX|32|NM|10002^PCT^99MRC||1.40|mL/L|1.08-2.82|N|||F
OBX|33|IS|12014^Anemia^99MRC||T||||||F
OBX|34|IS|15180-3^Hypochromia^LN||T||||||F
OBX|35|NM|15001^WBC Histogram. Left Line^99MRC||7||||||F
OBX|36|NM|15002^WBC Histogram. Right Line^99MRC||65||||||F
OBX|37|NM|15003^WBC Histogram. Middle Line^99MRC||30||||||F
OBX|38|ED|15008^WBC Histogram. BMP^99MRC||^Image^BMP^Base64^„„WBC
Histogram bmp data„„||||||F
OBX|39|NM|15051^RBC Histogram. Left Line^99MRC||26||||||F
OBX|40|NM|15052^RBC Histogram. Right Line^99MRC||164||||||F
OBX|41|ED|15056^RBC Histogram. BMP^99MRC||^Image^BMP^Base64^„„RBC
Histogram bmp data„„||||||F
C-17
Appendices
MSH|^~\&|LIS||||20080617143944||ACK^R01|1|P|2.3.1||||||UNICODE
MSA|AA|1
QC message
C-18
Appendices
The content of the QC message differs from that of the sample analysis result: the MSH-11
value of the QC message is Q which indicates that it is a QC message; each QC message is
corresponding to one QC point in the IPU software which may contain several analysis results.
For example, there is one analysis result in an L-J QC message, while there are two analysis
results and one mean calculation result in an X-R QC message.
A QC messasge is composed of an MSH message head and several analysis results, each of
which contains the PID and OBR segments as the head of the sample message, as well as
several OBX segments to carry parameters and other information. The OBR-4 field of each
analysis result indicates the type of the result (X-R analysis result, X-R mean or L-J analysis
result). See Appendix: Message coding definition for details.
An example of the X-R QC message is shown as follows:
MSH|^~\&|BC-5300|Mindray|||20081120171602||ORU^R01|1|Q|2.3.1||||||UNICODE
PID|1||6666666||||20080807235959
OBR|1||6|00006^XR QCR^99MRC|||20080807142518|||||||||||||||||HM||||||||R&D Engineer
OBX|1|IS|05001^Qc Level^99MRC||M||||||F
OBX|2|IS|08001^Take Mode^99MRC||C||||||F
OBX|3|IS|08002^Blood Mode^99MRC||W||||||F
OBX|4|NM|6690-2^WBC^LN||0.00|10*9/L|||||F
OBX|5|NM|704-7^BAS#^LN||***.**|10*9/L|||||F
OBX|6|NM|706-2^BAS%^LN||**.*|%|||||F
OBX|7|NM|751-8^NEU#^LN||***.**|10*9/L|||||F
OBX|8|NM|770-8^NEU%^LN||**.*|%|||||F
OBX|9|NM|711-2^EOS#^LN||***.**|10*9/L|||||F
OBX|10|NM|713-8^EOS%^LN||**.*|%|||||F
OBX|11|NM|731-0^LYM#^LN||***.**|10*9/L|||||F
OBX|12|NM|736-9^LYM%^LN||**.*|%|||||F
OBX|13|NM|742-7^MON#^LN||***.**|10*9/L|||||F
OBX|14|NM|5905-5^MON%^LN||**.*|%|||||F
OBX|15|NM|789-8^RBC^LN||0.02|10*12/L|||||F
OBX|16|NM|718-7^HGB^LN||0|g/L|||||F
OBX|17|NM|787-2^MCV^LN||***.*|fL|||||F
OBX|18|NM|785-6^MCH^LN||***.*|pg|||||F
OBX|19|NM|786-4^MCHC^LN||****|g/L|||||F
OBX|20|NM|788-0^RDW-CV^LN||**.*|%|||||F
OBX|21|NM|21000-5^RDW-SD^LN||***.*|fL|||||F
OBX|22|NM|4544-3^HCT^LN||0.0|%|||||F
OBX|23|NM|777-3^PLT^LN||4|10*9/L|||||F
OBX|24|NM|32623-1^MPV^LN||**.*|fL|||||F
OBX|25|NM|32207-3^PDW^LN||**.*||||||F
OBX|26|NM|10002^PCT^99MRC||.***|%|||||F
OBX|27|NM|10003^GRAN-X^99MRC||6||||||F
OBX|28|NM|10004^GRAN-Y^99MRC||32||||||F
OBX|29|NM|10005^GRAN-Y(W)^99MRC||20||||||F
OBX|30|NM|10006^WBC-MCV^99MRC||83||||||F
OBX|31|NM|15001^WBC Histogram. Left Line^99MRC||10||||||F
C-19
Appendices
C-20
Appendices
QC response message
The only difference between the QC response message and the analysis result response
message is that the MSH-11 value of the QC response message is Q.
An example of the ACK X-R QC message is shown as follows:
C-21
Appendices
MSH|^~\&|LIS||||20081120171602||ACK^R01|1|Q|2.3.1||||||UNICODE
MSA|AA|1
MSH|^~\&|BC-5300|Mindray|||20081120174836||ORM^O01|4|P|2.3.1||||||UNICODE
ORC|RF||SampleID1||IP
MSH|^~\&|LIS||||20081120174836||ORR^O02|1|P|2.3.1||||||UNICODE
MSA|AA|4
PID|1||ChartNo^^^^MR||^FName||19810506|NT
PV1|1|nk^^Bn4|||||||||||||||||NewCharge
ORC|AF|SampleID1|||
OBR|1|SampleID1||||20060506||||tester|||Diagnose
content....|20060504||||||||20080821||HM||||Validator||||Operator
OBX|1|IS|08001^Take Mode^99MRC||A||||||F
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC||||||F
C-22
Appendices
OBX|4|IS|01002^Ref Group^99MRC||XXXX||||||F
OBX|5|NM|30525-0^Age^LN||1|hr|||||F
OBX|6|ST|01001^Remark^99MRC||remark content....||||||F
An example of the inquiry response message with no search result is shown as follows, in
which the MSA-2 field indicates the result of the response. In this example, the MSA-2 value is
“AR”, indicating the inquiry was rejected; if it is “AE", then there is an error in the inquiry
process.
MSH|^~\&|LIS||||20081120175238||ORR^O02|1|P|2.3.1||||||UNICODE
MSA|AR|9
CE - Code Element
<identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^
<alternate text (ST)> ^ <name of alternate coding system (ST)>
CM - Composite
<ID (ST)> ^ <check digit (ST)> ^ <code identifying the check digit scheme employed (ID)> ^ <
assigning authority (HD)> ^ <identifier type code (IS)> ^ < assigning facility (HD)>
ED – Encapsulate Data
EI - Entity Identifier
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID (ST)> ^ <universal ID type (ID)>
FC – Financial Class
HD - Hierarchic designator
FT - Formatted text
This data type is derived from the string data type by allowing the addition of embedded
formatting instructions. These instructions are limited to those that are intrinsic and
independent of the circumstances under which the field is being used.
C-23
Appendices
The value of such a field follows the formatting rules for an ST field except that it is drawn from
a site-defined (or user-defined) table of legal values. There shall be an HL7 table number
associated with IS data types.
The value of such a field follows the formatting rules for an ST field except that it is drawn from
a table of legal values. There shall be an HL7 table number associated with ID data types.
NM - Numeric
PL - Person location
<point of care (IS )> ^ <room (IS )> ^ <bed (IS)> ^ <facility (HD)> ^ < location status (IS )> ^
<person location type (IS)> ^ <building (IS )> ^ <floor (IS )> ^ <location description (ST)>
PT - Processing type
SI - Sequence ID
A non-negative integer in the form of an NM field. The uses of this data type are defined in the
chapters defining the segments and messages in which it appears.
ST – String
TS - Time stamp
In Version 2.3, use instead of the CN data type. <ID number (ST)> ^ <family name (ST)> &
<last_name_prefix (ST) ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR
or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <source table (IS)> ^
<assigning authority (HD)> ^ <name type code (ID)> ^ <identifier check digit (ST)> ^ <code
identifying the check digit scheme employed (ID)> ^ <identifier type code (IS)> ^ <assigning
facility (HD)> ^ <name representation code (ID)>
In Version 2.3, replaces the PN data type. <family name (ST)> ^ <given name (ST)> &
<last_name_prefix (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^
<prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^ <name type code (ID) > ^ <name
representation code (ID)>
C-24
Appendices
1. In the HL7 message, the OBR-4(Universal Serview ID) field is used for identifying the type
of the test results, for example, to identify the results as sample results, microscope exam
results or QC results in the form of “ID^Name^EncodeSys”. The coding values of the field are
listed in the table below.
2. Each OBX segment contains one test parameter or information of other data and consists of
the following fields: OBX-2, it indicates the HL7 type of the data contained; OBX-3, it is the
mark of the data in the form of “ID^Name^EncodeSys”; OBX-5, it contains the value of the data;
OBX-6, it contains the unit for the parameter, expressing in the ISO standard.
The HL7 types and coding marks of all the communication data are listed in Table 10. The
units of all the communication data are listed in table 11.
Table 10 HL7 types and coding marks
HL7 Type Coding OBX-3 field example
Data Name EncodeSys
(OBX-2) (ID)
Other data
08001^Take
Take Mode IS 08001 Take Mode 99MRC
Mode^99MRC
08002^Blood
Blood Mode IS 08002 Blood Mode 99MRC
Mode^99MRC
08003^Test
Test mode IS 08003 Test Mode 99MRC
Mode^99MRC
30525- 30525-0^Age^LN
Age NM Age LN
0
C-25
Appendices
01001^Remark^99M
Remark ST 01001 Remark 99MRC
RC
01002^Ref
Ref Group IS 01002 Ref Group 99MRC
Group^99MRC
05001^Qc
QC Level IS 05001 Qc Level 99MRC
Level^99MRC
Analysis results data
WBC NM 6690-2 WBC LN 6690-2^WBC^LN
BAS NM 704-7 BAS# LN 704-7^BAS#^LN
BAS_PER NM 706-2 BAS% LN 706-2^BAS%^LN
NEU NM 751-8 NEU# LN 751-8^NEU#^LN
NEU_PER NM 770-8 NEU% LN 770-8^NEU%^LN
EOS NM 711-2 EOS# LN 711-2^EOS#^LN
EOS_PER NM 713-8 EOS% LN 713-8^EOS%^LN
LYM NM 731-0 LYM# LN 731-0^LYM#^LN
LYM_PER NM 736-9 LYM% LN 736-9^LYM%^LN
MON NM 742-7 MON# LN 742-7^MON#^LN
MON_PER NM 5905-5 MON% LN 5905-5^MON%^LN
26477- 26477-0^*ALY#^LN
ALY NM *ALY# LN
0
13046- 13046-8^*ALY%^LN
ALY_PER NM *ALY% LN
8
LIC NM 10000 *LIC# 99MRC 10000^*LIC#^99MRC
10001^*LIC%^99MR
LIC_PER NM 10001 *LIC% 99MRC
C
RBC NM 789-8 RBC LN 789-8^RBC^LN
HGB NM 718-7 HGB LN 718-7^HGB^LN
MCV NM 787-2 MCV LN 787-2^MCV^LN
MCH NM 785-6 MCH LN 785-6^MCH^LN
MCHC NM 786-4 MCHC LN 786-4^MCHC^LN
RDW_CV NM 788-0 RDW-CV LN 788-0^RDW-CV^LN
21000- 21000-5^RDW-SD^L
RDW_SD NM RDW-SD LN
5 N
HCT NM 4544-3 HCT LN 4544-3^HCT^LN
PLT NM 777-3 PLT LN 777-3^PLT^LN
32623- 32623-1^MPV^LN
MPV NM MPV LN
1
32207- 32207-3^PDW^LN
PDW NM PDW LN
3
C-26
Appendices
C-27
Appendices
Manual %. Manual^LN
Abnormal 29261-5^Abnormal
29261-
AbnLymph NM Lymphs%. LN Lymphs%.
5
Manual Manual^LN
33840- Monoblasts%. 33840-0^Monoblasts
Monoblast NM LN
0 Manual %. Manual^LN
13599- Promonocytes%. 13599-6^Promonocyt
Promonocytes NM LN
6 Manual es%. Manual^LN
Monocytes%. 744-3^Monocytes%.
Monocyte NM 744-3 LN
Manual Manual^LN
18309- NRBCs%. 18309-5^NRBCs%.
NRBCS NM LN
5 Manual Manual^LN
31112- Reticulocytes%. 31112-6^Reticulocyte
Reticulocyte NM LN
6 Manual s%. Manual^LN
11000^Undefined
Undefined
UndefinedCells NM 11000 99MRC Cells%.
Cells%. Manual
Manual^99MRC
11001^Other
OtherAbnormalC Other Abnormal
NM 11001 99MRC Abnormal Cells%.
ells Cells%. Manual
Manual^99MRC
30341-
ESR NM ESR LN
2
Analysis results medium data(WBC, RBC, PLT histogram and scattergram data, etc.)
15000^WBC
WBC Histogram WBC Histogram.
ED 15000 99MRC Histogram
Binary Data Binary
Binaray^99MRC
WBC Histogram 15001^WBC
WBC Histogram.
Left NM 15001 99MRC Histogram. Left
Left Line
Discriminator Line^99MRC
WBC Histogram 15002^WBC
WBC Histogram.
Right NM 15002 99MRC Histogram. Right
Right Line
Discriminator Line^99MRC
WBC Histogram 15003^WBC
WBC Histogram.
Middle NM 15003 99MRC Histogram. Middle
Middle Line
Discriminator Line^99MRC
WBC Histogram 15004^WBC
WBC Histogram.
Original Data NM 15004 99MRC Histogram. Meta
Meta Length
Length Length^99MRC
WBC Histogram IS 15005 WBC Histogram. 99MRC 15005^WBC
C-28
Appendices
C-29
Appendices
12021^Sample
Aspiration
IS 12021 Sample Abnormal 99MRC Abnormal^LN
Abnormal
System 12064^System
IS 12064 System Error 99MRC
Abnormal Error^LN
WBC 12000^WBC
WBC Abnormal
Scattergram IS 12000 99MRC Abnormal
scattergram
Abn. scattergram^99MRC
WBC Histogram WBC Abnormal 12001^WBC
IS 12001 99MRC
Abn. histogram Abnormal
C-30
Appendices
histogram^99MRC
12002^Leucocytosis^
Leucocytosis IS 12002 Leucocytosis 99MRC
99MRC
12003^Leucopenia^9
Leucopenia IS 12003 Leucopenia 99MRC
9MRC
12004^Neutrophilia^9
Neutrophilia IS 12004 Neutrophilia 99MRC
9MRC
12005^Neutropenia^
Neutropenia IS 12005 Neutropenia 99MRC
99MRC
12006^Lymphocytosi
Lymphocytosis IS 12006 Lymphocytosis 99MRC
s^99MRC
12007^Lymphopenia^
Lymphopenia IS 12007 Lymphopenia 99MRC
99MRC
12008^Monocytosis^
Monocytosis IS 12008 Monocytosis 99MRC
99MRC
12009^Eosinophilia^9
Eosinophilia IS 12009 Eosinophilia 99MRC
9MRC
12010^Basophilia^99
Basophilia IS 12010 Basophilia 99MRC
MRC
12011^WBC
WBC abnormal IS 12011 WBC Abnormal 99MRC
Abnormal^99MRC
17790- 17790-7^WBC Left
Left Shift? IS WBC Left Shift? LN
7 Shift?^LN
Immature 34165- Imm 34165-1^Imm
IS LN
Granulocyte? 1 Granulocytes? Granulocytes?^LN
Abnormal/Atypic 15192- 15192-8^Atypical
IS Atypical Lymphs? LN
al Lymphocyte? 8 Lymphs?^LN
RBC Lyse 34525- 34525-6^rstRBC^LN
IS rstRBC LN
Resist? 6
RBC System 12049^RBC Error^LN
IS 12049 RBC Error 99MRC
Abnormal
12012^Erythrocytosis
Erythrocytosis IS 12012 Erythrocytosis 99MRC
^99MRC
12013^RBC
RBC Histogram RBC Abnormal
IS 12013 99MRC Abnormal
Abn. distribution
distribution^99MRC
15150- 15150-6^Anisocytosis
Anisocytosis IS Anisocytosis LN
6 ^LN
Macrocytosis IS 15198- Macrocytes LN 15198-5^Macrocytes
C-31
Appendices
5 ^LN
15199- 15199-3^Microcytes^
Microcytosis IS Microcytes LN
3 LN
10379- 10379-6^RBC Dual
Dimorphologic IS RBC Dual Pop LN
6 Pop^LN
12014^Anemia^99M
Anemia IS 12014 Anemia 99MRC
RC
15180- 15180-3^Hypochromi
Hypochromia IS Hypochromia LN
3 a^LN
HGB 12015^HGB
IS 12015 HGB Interfere 99MRC
Abn/Interfere? Interfere^99MRC
12022^RBC
RBC clump? IS 12022 RBC Clump 99MRC
Clump^LH
12024^Iron
Iron Deficiency? IS 12024 Iron Deficiency 99MRC
Deficiency^LH
PLT Histogram PLT Abnormal 12016^PLT Abnormal
IS 12016 99MRC
Abn. Distribution Distribution^99MRC
12017^Thrombocytos
Thrombocytosis IS 12017 Thrombocytosis 99MRC
is^99MRC
12018^Thrombopenia
Thrombopenia IS 12018 Thrombopenia 99MRC
^99MRC
7796-6^Platelet
PLT Clump? IS 7796-6 Platelet Clump? LN
Clump?^LN
C-32
Appendices
L/L L/L
mmol/L mmol/L
% %
fL fL
um^3 um3
pg pg
fmol fmol
amol amol
Year (age unit) yr
Month (age unit) mo
Day (age unit) d
Hour (age unit) hr
3. Part of the OBX messages adopt the customized enumeration values listed in the following
table.
C-33
Appendices
4. Histogram data: according to the software setup, there are several cases for the
communication of the histogram data.
(1) Do not transmit the histogram data.
(2) Transmit histogram data in the form of bitmap. In the OBX segment, the value of the data
type field is “ED”; the value of data is in the form of “^Image^BMP^Base64^……histogram data
in the form of bitmap……”, the “image” herein indicates the image data is transmitted; the
“BMP” is the customized sub-data type, it indicates the BMP bitmap is transmitted; “Base64”
indicates the coding method of the data.
(3) Transmit binary histogram data. In the OBX segment, the value of the data type field is
“ED”; the value of data is in the form of “^Application^Octet-stream^Base64^……histogram
data……”; “Application^Octer-stream” herein is the sub-data of HL7 standard, indicating the
binary data type defined by the application program; “Base64” indicates the coding method of
the data.
Note: to transmit the histogram data in the form of bitmap or binary is determined by the ID
field in the OBX segment.
5. Scattergram data: when transmitting bitmap data, in the OBX segment, the value of the data
type field is “ED”; the value of data is in the form of “^Image^BMP^Base64^……scattergram
data in the form of bitmap……”. The “Image^BMP^Base64” indicates the bitmap data is of
BMP type and coded by Base64.
6. Age communication: the age in the patient information will be transferred as an OBX
message segment composed of an integer and the age unit. If the age in the IPU software is
displayed as “<1”, then the age value in the communication is “0”.
(1) Select the 3 adjacent bytes (i.e. 24 bit) from the data stream to be coded; from left to right,
C-34
Appendices
divide them into 4 groups of 6-bit; then, ASCII string is obtained by mapping as per the Table
12.
Initial data 15H A3H 4BH
Binary data 00010101 10100011 01001011
6-bit group obtained after dividing 000101 011010 001101 001011
Corresponding coding value 5H 1AH 0DH 0BH
Corresponding character F a N L
C-35
Appendices
C-36
P/N: 046-001567-00(6.0)