2015 - 12 - 1114 - 24 - 22BriCyte - E6 - Operator's Manual - V4.0 - EN
2015 - 12 - 1114 - 24 - 22BriCyte - E6 - Operator's Manual - V4.0 - EN
Flow Cytometer
Operator‘s Manual
© 2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator‘s Manual, the issue date is 2015-05.
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
I
local requirements;and
the product is used in accordance with the instructions for use.
II
Warranty
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.
III
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Tel: 0049-40-2513175
Fax: 0049-40-255726
IV
Table of Contents
1 Using This Manual ........................................................................................... 1-1
1.1 Introduction ........................................................................................................ 1-1
1.2 Who Should Read This Manual .......................................................................... 1-2
1.3 How to Find Information ..................................................................................... 1-3
1.4 Conventions Used in This Manual ...................................................................... 1-4
1.5 Precautions, Limitations and Hazards................................................................. 1-5
1.6 Symbols........................................................................................................... 1-17
1
Table of Contents
2
Table of Contents
3
Table of Contents
4
1 Using This Manual
1.1 Introduction
This chapter explains how to use your Operator's Manual of BriCyte E6 Flow Cytometer, which
is shipped with your cytometer and contains reference information about the BriCyte E6 and
procedures for operating, troubleshooting and maintaining the cytometer. Read this manual
carefully before operating your BriCyte E6 and operate the BriCyte E6 strictly as instructed in
this manual.
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Form Meaning
[××] all capital letters enclosed in [ ] indicate a key name (either on
the pop-up keyboard or the external keyboard), such as
[ENTER].
"××" letters included in " " indicate text you can find on the user
interface
XX italic letters indicate chapter titles
All illustrations in this manual are provided as examples only. They may not necessarily reflect
your BriCyte E6 setup or data displayed.
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Symbols Meaning
read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.
All the samples, controls, wastes and areas contacted by 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 any component of the cytometer leaks, the leaked liquid is potentially
biohazardous.
All the cytometer components and surfaces are potentially infectious, so
take proper protective measures for operation and maintenance.
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WARNING
This cytometer must be operated by skilled/trained clinical professionals.
Please check the firmness of all the doors and covers before running the
cytometer.
Make sure all the safety measurements are adopted. It is prohibited to
disable any safety device or sensor.
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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.
Do not try to pull the autoloader door open forcefully when it is locked.
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CAUTION
Please use the cytometer strictly as instructed by this manual.
Running auto setup and QC analysis when there is an error may lead to
incorrect analysis results. If an error is reported in the process, remove the
error first before continuing with the auto setup or QC analysis.
Improper service may damage the cytometer. Make sure you service the
cytometer strictly as instructed by this manual.
For problems not mentioned in this manual, contact Mindray customer
service department for service advice.
Only parts supplied by the manufacturer can be used for maintenance. For
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NOTE
This manual is intended to be read by clinical laboratory professionals to:
1. perform daily operating tasks;
2. perform system maintenance and troubleshooting;
3. learn how to operate the cytometer.
The purpose of this cytometer is to identify the normal patient, with all
normal system-generated parameters, and to flag or identify patient results
that require additional studies.
When the indicator flickers in green and yellow or green and red alternately,
the software or hardware of the cytometer is abnormal. Please Contact
Mindray Customer Service Department.
Repeat the operation if failed to choose the content; check the connection
of the mouse if necessary. If the problem still exists, please contact
Mindray or your local distributor immediately.
More than one check box can be chosen at the same time in one setting
option.
Text boxes of different use require different input characters.
You don't have to enter the separators in the date box and the IP box.
The scroll bar (horizontal/vertical) will appear if the content of the text box
can not be displayed in one sight. You can scroll or use the [↑], [↓] keys on
the keyboard to view the information fully.
3D plot cannot be sent to the report.
The population name entered cannot include space or symbols like "()".
Store and use the reagents as instructed by instructions for use of the
reagents.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
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After installing a new container of reagent, keep it still for a while before use.
After installation of the MRFlow software, authorization information shall be
obtained from the cytometer; otherwise the software cannot be used as
normal.
Each cytometer may authorize installation of the MRFlow software on 3 PCs.
If you need authorization for more PCs, please Contact Mindray Customer
Service Department or your local distributor.
After getting authorization, the cytometer may not be connected for the
authorization check to run the MRFlow software.
The calibration factor entered must be within the range 50%~150%. If correct
absolute count cannot be obtained after adjusting the calibration factor,
please contact Mindray Customer Service Department or your local
distributors.
The password cannot be null and up to 12 characters can be entered.
The ”Mindray templates” and "Custom templates" are default groups which
cannot be deleted.
Maximum pixel of the logo picture allowed is 150*150.
The “HLA-B27 Lot NO.” and cutoff value must be entered correctly in the
“Reagent Setup” screen, otherwise, incorrect results may be otained when
running samples of HLA-B27-Auto Mindray template.
Modificaitons to “Auto-compensation Settings” will not be applied to
already existed samples.
Use the reagents specified by the manufacturer only. Store and use the
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Check if the reagents are properly connected before using the cytometer.
The default user ID and password for administrator are both "Admin".
The user ID and password may be consisted of 1-12 characters, and the
password cannot be null.
The system opens different functions to the user according to the access
level. The system identifies the user level based on the user ID and the
password entered when the user logs in.
Time needed for startup initialization depends on how the cytometer was
previously shut down.
You may start up the cytometer first or run the software first during the
startup procedure.
Before running the software, make sure the power cord of the PC is properly
connected with the cytometer. If the cytometer and the PC are not
connected, startup initialization will not be performed.
Only 1 login user is allowed at a time, to switch user, you need to log out the
current user by clicking the "Logout" button in the quick icon area, and then
enter user ID and password of the new user into the login dialog box and
click "OK" to log in the software system again
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Abnormal shutdown will result in loss of sample information that is not yet
saved.
Review results of Mindray panels after acquisition and adjust gates if there
are any flags about auto-algorithm or inaccurate differentiation results.
To edit Mindray templates after finishing acquisition, see 6.11 Analyzing
Results.
The templates in "Empty", “Mindray templates” and “QC templates” groups
are default panel templates, which cannot be overwritten.
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The analysis time and tube position cannot be edited after acquisition.
If the “Auto-increase Carousel ID” check box is disabled, a total of 40 tubes
can be added at most in a batch.
If "2-Way LIS/HIS" is selected in the "Setup" - "Communication Setup"
screen, all sample IDs of the batch are fixed to “#” and should be modified in
the worklist.
The exported file takes sample as the unit, an information unit includes
control panel options, sample information, panel template, report, etc.
After acquisition, the modified Mindray template cannot be saved as
Mindray template.
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The “Copy tube contents” function is not applicable to samples that use
Mindray templates, have been validated or are being transmitted.
If “Paste sample contents” is selected, the “Acquisition conditions” will not
be applied to acquired tubes.
You cannot paste sample contents to a sample with a different panel.
The “Paste/copy sample contents” function is not applicable to samples
that use Mindray templates or have already been validated.
If the sample to which the contents are to be pasted has less tubes than the
copied one, new tubes will be added automatically to make up for the
difference; if it has more tubes than the copied one, the contents will not be
copied to the extra tubes.
Use the control and reagents specified by the manufacturer only. Store and
use the control and reagents as instructed by instructions for use of the
reagents. It is recommended that run QC analysis everyday before
acquisition.
If Mindray templates are to be used in the day, auto setup will be necessary
before running samples, see 7.2 Auto Setup.
The BATCH CODE shall not be empty and up to 10 digits can be entered. You
can enter characters, numbers, letters and special characters.
Use the particles specified by the manufacturer only. Using particles other
than specified may lead to incorrect results. Do not use particles other than
specified.
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Store and use the particles as instructed by instructions for use of the
particles.
To get reliable results, make sure you prepare the particles on the day of
analysis and store it in the dark.
Store and use the control as instructed by instructions for use of the
control.
To get reliable QC analysis results, make sure you prepare the control
particle on the day of analysis and store it in the dark.
If the QC analysis fails, make sure there is no operation mistake and retry.
When the QC analysis keeps failing, contact our service department to
calibrate the cytometer if necessary.
The green line and the corresponding values of the QC points will not be
printed.
Once information of a new batch parameter QC is entered, all the following
parameter QC results will be included in the reports of the new batch
automatically, even if the old batch is selected in the QC information screen.
Avoid strong turbulence to the sheath container and collision with other
objects. Otherwise, the error report may be unreliable.
If the self-test result is abnormal, the indicator of the software flickers red,
and a dialog box pops up to tell “Self-test failed”. Try again after clicking
“OK”. If the result is still abnormal after you tried several times, please
contact Mindray Service Department or your local distributor.
This chapter is not a complete service manual and is limited to problems
that are readily diagnosed and/or corrected by the user of the cytometer.
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1.6 Symbols
You will find the following symbols in this manual:
Symbols Meaning
read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.
CAUTION
During the daily use of the cytometer, especially the cleaning process, the
operator shall ensure the intactness of the labels.
Symbols Meaning
CAUTION,RISK OF DANGER
Note: Indicates the need for the user to consult the
instructions for use for important cautionary information.
BIOLOGICAL RISKS
ALTERNATING CURRENT
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SERIAL NUMBER
BATCH CODE
CATALOGUE NUMBER
USE BY
TEMPERATURE LIMIT
DATE OF MANUFACTURE
MANUFACTURER
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SENSOR JACK
SHEATH INLET
WASTE OUTLET
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Operate caution while opening or closing the autoloader door to avoid pinching!
To avoid injury, do not put your hand around the tube access door
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1
To avoid injury, do not put your hand around the tube holder!
Take proper protective measures against possible spillage from the tube while operating
the cytometer!
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Note: laser radiation when open this cover or interlock lose efficacy.
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Note: laser radiation when open this cover. Avoid direct exposure to the laser beam
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2 Understanding Your Cytometer
2.1 Introduction
BriCyte E6 Flow Cytometer provides quantitative analysis of biochemical and biophysical
characteristics of cells and other biological particles for clinical medicine and basic scientific
research.
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2.2 Parameters
NOTE
The purpose of this cytometer is to identify the normal patient, with all
normal system-generated parameters, and to flag or identify patient results
that require additional studies.
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2.3 Hardware
2.3.1 Overview
The BriCyte E6 Flow Cytometer consists of the flow cytometer and the peripherals. The flow
cytometer consists of the optical system, fluidics system, mechanical system, and control &
signal processing system. The peripherals include PC, client software (MRFlow), reagent
carriage and assembly. The autoloader and barcode scanner are optional components.
The appearance of the product is as follows:
Components Function
① Flow cytometer Sample analysis
② PC, MRFlow software Controls the cytometer and processes data
③ Reagent carriage and Accommodates reagents and detects reagent volume
assembly
④ Barcode scanner Reads sample and control information
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Power indicator
The power indicator is located on the front cover of the cytometer, which tells you about
the status of the cytometer including ready, running, error, standby and on/off, etc.
NOTE
When the indicator flickers in green and yellow or green and red alternately,
the software or hardware of the cytometer is abnormal. Please Contact
Mindray Customer Service Department.
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Tube holder
You can use the tube holder to load one sample tube each time.
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Autoloader
The autoloader is located in the front of the cytometer. You can use it to load tubes
automatically.
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Network interface
You can use the network interface to connect the cytometer to the PC.
Power switch
You can use the power switch to start up or shut down the cytometer.
CAUTION
Do not turn on/off the switch repeatedly in a short time to avoid damaging
the cytometer.
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2.3.3 Cytometer
There are three standard configurations, which vary in optical system(See Appendix B.4
Configuration). The 2-laser, 4-color configuration can be upgraded to 2-laser, 5-color or
2-laser, 6-color configuration.
WARNING
The installation, authorization, upgrade and modification of the cytometer
and software must be performed by Mindray-authorized personnel.
Optical system
The optical system consists of lasers, mirrors, filters and optical detectors. It provides light
sources and collects scattered and emitted light from particles in sample stream.
The double temperature control systems contribute to the pointing stability of the lasers, which
ensure that the flow cytometer always show excellent performance under varied ambient
temperatures.
Filters of fluorescence channels can be replaced easily by users, without further calibration of
the optical system.
Fluidic system
The fluidic system consists of flow cell, flow sensors, ceramic pumps, valves and the tubing. It
provides steady sheath flow and sample stream and confine particles to move in single file
through the laser beams.
Mechanical system
The mechanical system provides the frame of the cytometer, constitutes structures of the
fluidic, optical and electronic systems, and realizes functions like system debug, manual
loading and autoloading (Optional, including batch and single tube mode).
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2.3.4 Peripherals
PC and client software (MRFlow)
MRFlow is the PC software dedicated to BriCyte E6 Flow Cytometer. It sends operation
commands to the cytometer, receives and processes information, and recalculates area and
height values according to the compensation matrix. It also provides data analysis tools like
graphs, statistics and gates and functions like off-line analysis, setup and log.
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Title area
Displays name of the software.
Login name
Displays name of the current user.
Tab screen
You will find the following tab screens:
Work Center, QC, Service, Setup and Log
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Client area
Displays contents of the screens.
Control panel
Displays the buttons or setup options for cytometer control.
Status area
Displays error, progress and liquid level information.
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CLICK
Move the pointer to the desired content; left click the mouse then release.
NOTE
Repeat the operation if failed to choose the content; check the connection
of the mouse if necessary. If the problem still exists, please contact Mindray
or your local distributor immediately.
Double click
Move the pointer to the desired content, left click the mouse twice rapidly then release.
NOTE
Repeat the operation if failed to choose the content; check the connection
of the mouse if necessary. If the problem still exists, please contact Mindray
or your local distributor immediately.
Right click
Move the pointer to the desired content; right click the mouse then release.
NOTE
Repeat the operation if failed to choose the content; check the connection
of the mouse if necessary. If the problem still exists, please contact Mindray
or your local distributor immediately.
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(horizontal/vertical) will appear. You can scroll the scroll bar in the following ways to check the
rest of the information. A scroll bar is shown below:
Move the pointer to the slide bar, left click the mouse and hold, then scroll the bar at will.
Click the blank area on the scroll bar.
Tab screen
Tag screen displays one page of the multipage information. For example, click the "Host
Setup", "Area Factor", "Graph Parameters" and "User Management" tabs on the "Setup"
screen; you can enter the corresponding screens to view information.
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Button
Common buttons
After clicking the button, certain function will perform. For example, the system will start data
transmission after clicking the "Comm." button as shown below.
After clicking the arrow button on the date text box, a date box will pop up.
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Choose the year: click the displayed year twice, there will be several years listed for you to
select. If the desired year is not displayed, click the year range displayed on top to go to the
year range list. Choose the desired year range and then the year.
Choose the month:
Operation 1: click the arrow button on the both sides of the date box to switch and choose the
desired month.
Operation 2: click the displayed month, then click the desired month from the list appeared as
shown below.
Radio button
Click the single choice button, a mark appears in the circle, indicating the option is chosen. For
example, click "Mid" in the figure below to select the flow rate "Mid".
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NOTE
Only one radio button can be chosen for one setting.
Check Box
Click the check box, a "√" mark appears in the frame, indicating the option is chosen.
Click the option again, the ―√‖ disappeared, it means the option is not chosen as shown below.
NOTE
More than one check box can be chosen at the same time in one setting
option.
Text box
Click the text box, and then you can start editing when the cursor appears. You can enter the
characters from the location of the cursor and the cursor moves to the right at the time. A
product ID has been entered into the text box as follows.
You can also proceed with the following operations in the text box:
Move the cursor to the left or right by using the [←], [→] keys on the keyboard.
Move the cursor to the left of the initial character or the right of the end character by
pressing the [Home], [End] keys on the keyboard.
Delete the character on the right of the cursor by using the [Delete] on the keyboard.
Delete the character on the left of the cursor by using the [Backspace] key on the
keyboard.
Switch to other text box by using the [Tab] key on the keyboard.
NOTE
Text boxes of different use require different input characters.
You don't have to enter the separators in the date box and the IP box.
The scroll bar (horizontal/vertical) will appear if the content of the text box
cannot be displayed in one sight. You can scroll or use the [↑], [↓] keys on
the keyboard to view the information fully.
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Combo box
The combo box consists of a text box and an arrow button, which is shown below:
See "Arrow button of the combo box" for details about selecting. See "Text box" for details
about editing if it is editable.
See "Arrow button of the date text box" for details to complete date selection, or see "Text box"
for details to edit date in the date text boxes.
Form/Table
The form contains several cells and check boxes (sometimes).
Click a cell, it is chosen as shown below:
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Select the cell by using the [↑], [↓], [←], and [→] keys on the keyboard.
Select the initial or end form unit of the current row by using the [Home], [End] keys on the
keyboard.
For an editable form unit, a cursor will appear in it 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. See the
following figure for the cell under editing status.
Move the cursor to the left or right in the form unit by using the [←], [→] keys on the
keyboard.
Move the cursor to the left of the initial character or the right of the end character by
pressing the [Home], [End] keys on the keyboard.
Delete the character on the right of the cursor by using the [Delete] 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.
In some forms/tables, you may perform the following operations:
Sort
Click the title of a column, the rows will be sequenced by the condition of the column in
ascending/descending order, click the title again to change to descending/ascending order.
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Dialog box
There are many types of dialog box with varied functional buttons, which are the "OK" dialog
box, the "OK/Cancel" dialog box, the "Yes/No" dialog box, the "Yes/No/Cancel" dialog box, and
other dialog boxes of special indication.
A dialog box consists of the title area, information area and function button(s). Take the
following "Yes/No/Cancel" dialog box for example:
After changing the settings, click to close the dialog box and save the change; or click "No" to
close the dialog box without saving the change.
Click the button on the right of the title area, or ―Cancel‖, or the [Esc] key on the keyboard
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2.6.1 Graphs
The graphs supported by the MRFlow are: Histogram (single parameter), Dot Plot (2
parameters), Contour Plot (2 parameters), Density Plot (2 parameters) and 3D Plot (3
parameters). The dot plot will be introduced as an example.
Create graphs
Standard create
2. Click the "Gate (default setup is All Events)", "X dimension" and "Y dimension" pull-down
list to select data source and parameters of the dimensions.
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Quick create
Double click on the target gate in the graph area (Refer to 2.6.2 GatesGat for the gating
method), a plot of the same dimensions as the original dot plot will be created in the blank area,
whose data source (GATE) is the target gate. See the following figures; double click on the
Lym gate in Plot 1.
Modify settings
Click the pull-down list of the dimensions to select parameters for axes. See the following
figure.
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Click the "GATE" pull-down list to select data source of the plot, as shown in the following
figure.
Set display ranges of channel dimensionsClick the button next to the axis name to set the
display ranges of channel dimensions, as shown in the following figures.
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Fixed at 1.00 by
Biexponential 3.00~6.02
default, cannot be set
You can apply the set minimum and maximum value settings to one of the following scopes:
Apply to dim. of current channel: the channel display range of current tube will be refreshed.
Apply to *** (channel) of the sample: for all tubes under current sample, the display range of
the very channel will be refreshed.
Apply to all dims of the sample: for all tubes under current sample, the display range of all
channels will be refreshed.
Reset
Click the ―Reset‖ button to restore default display range settings for impacted channel(s) under
the selected application rule.
Reset all:
Click the ―Reset all‖ button to restore the default display range settings for all channels of all
tubes under current sample.
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Magnification/Partial Magnification
Magnification: Click the button on the upper right of the plot to magnify the plot. The
magnified plot will be displayed in the pop-up window shown in the following figure.
Full screen magnification: Click the button on the upper right of the pop-up window to
magnify the plot to full screen.
Partial magnification: Click the button on the lower right of the window, move the pointer
to the plot, and click the start point of the part to be magnified, a drag box will be displayed in
the plot window. Drag the pointer to the end point of the target area, as shown in the following
figure.
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Repeat the above procedure to realize partial magnification if necessary; Click the
button again and again to minify the plot gradually.
Send to report
Click the check box on the upper left of the plot window, the will turn to , and the plot
will be sent to the "Report Preview" screen. If the original plot is modified, the plot in the
"Report Preview" screen will change accordingly.
Click the check box again, the will turn to , and the plot will not be sent to the report.
NOTE
3D plot cannot be sent to the report.
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Adjust layout
Select the target plot, press the mouse and drag it, the position line will appear, as the arrow in
the following figure shows.
When the position line moves to target position, release the mouse, order of the plots will
change accordingly, as the following figure shows.
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2.6.2 Gates
Gates defined by the gating buttons include quadrant gate, rectangle gate, ellipse gate,
polygon gate, autopolygon gate, interval gate and bifurcated gate.
Create gates
Click the gating buttons to create gates in the plot window. After creating gates, the
eventswithin the gates will be filled with colors automatically, and the gates will be named
according to their types and creation order.
Quadrant gate: Click the gating button , and then click on the target position in the plot area,
a quadrant gate will be created using the target position as its center.
Rectangle gate: Click the gating button , and then click on the target position in the plot
area and drag the cursor, a rectangle gate will be created using the dragging start and end
points as the ends of the diagonal.
Ellipse gate: Click the gating button , and then click on the target position in the plot area
and drag the pointer, an ellipse gate will be created in the dragging area.
Polygon gate: Click the gating button , and then click on different points in the plot area in
certain order, a polygon gate will be created using the points as the vertexes.
NOTE
The vertexes of polygonal gate must be closed.
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Interval gate: Click the gating button , and then click in the plot area and drag the pointer,
an interval gate will be created in the dragging area.
Bifurcated gate: Click the gating button , and then click in the plot area, a bifurcated gate
will be created using the position clicked as its dividing line.
Paste gate
Right click the target graph and select "Paste gate" from the pop-up menu to add paste the
copied gate to the graph, as shown in below figure.
Overwrite gate
To replace a same type gate on the target graph, right click the gate to be replaced, and select
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"Overwrite gate" from the pop-up menu. Taking example as below, right click the polygon gate
P1 (shown in the left figure) and select ―Overwrite gate‖, the polygon gate is replaced by the
copied Lym gate (as shown in the right figure below) with the same name (P1).
Different from ―Overwrite gate‖, if you right click the P1 gate but select ―Paste gate‖, the copied
gate will be ―added‖ to the target graph with the name P2; and the existing P1 gate remains, as
shown in below figures:
NOTE
Only gates with the same name, dimension, source and type can be
synchronized.
Taking example shown in below figures: plot1 under Tube 1 is an FSC-H vs. SSC-H dot plot
with its data sourced from ―All Events‖. The plot has 3 gates: namely polygon gate P1, ellipse
gate P2 and rectangle gate 3.
And there is also an FSC-H vs. SSC-H dot plot under Tube 2 with the same data source of ―All
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Events‖. Similarly, the plot 2 has a polygon gate P1, an ellipse gate P2 and a rectangle gate 3;
only the gates are in different shapes and positions from those of plot 3.
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Delete gates
You may delete gate in the following ways.
Click the gate to be deleted, and then press the [Delete] or [Backspace] key on the keyboard.
Right click the gate to be deleted, and select "Delete" from the pop-up menu.
After deleting the gate, the population and statistics defined by the gate (see 2.6.3 Statistic) will
be deleted too.
NOTE
If the gate to be deleted is the data source(GATE) of other plots, when
deleting the gate, the message "The operation may affect plots, populations,
overlays or custom parameters, continue?”. After selecting "OK", the data
source of the plots and overlays affected will change to "All Events" from
the deleted gate. The custom parameters of the deleted gate will be deleted
directly.
Drag gates
You may move the gates by dragging them, dragging the vertexes can change the border of
the gates.
2.6.3 Statistics
The statistics area has 2 columns, the left column shows population hierarchy, including
relationship between populations and basic statistics, which are generated automatically
after creating plots and gates, and change with them synchronously; the right column shows
statistics, which can be added and modified as needed.
2-34
Understanding Your Cytometer
Population hierarchy
The population hierarchy reflects the hierarchy of the populations (defined by plots and gates)
of the current tube page. Basic statistics include the following:#Events, %Parent, %Total and
events/ul (only displayed when absolute count is enabled).
• #Event—total number of events in the defined population
• %Parent—number of events in the defined population divided by the number of events in the
parent gate (next population up in the hierarchy) expressed as a percentage
• %Total—number of events in the defined population divided by the total number of events in
the tube (all events), expressed as a percentage
• events/ul—number of events in the defined population divided by the calculated volume of
patient specimen (measurement volume divided by the dilution ratio )
Delete populations
Right click the population to be deleted, and select "Delete" from the pop-up menu, the
population will be deleted, and the gate in the plot area will be deleted too.
Edit populations
Select a population in the hierarchy to rename, the population name shown in the plot area
changes accordingly.
Click the color tag by the left of the population and select proper color from the "Color" window.
2-35
Understanding Your Cytometer
NOTE
The population name entered cannot include space or symbols like "()".
Select the logic AND, OR or NOT, the corresponding text box will be activated, select
populations to be combined from the pull-down lists, and enter the name into the "Population
Name" text box, and then click "OK", the new population will be displayed in the population
hierarchy.
Statistics area
To add statistics of a population in the hierarchy, select the line of the population and move it to
the statistic area on the right according to the following 2 ways:
Method 1: Right click the population hierarchy, and select "Add to statistics" from the pop-up
menu.
Method 2: Press the mouse and drag the selected population to the statistics area on the right.
Statistics of the target population are included in the statistic area.
See the following figure:
2-36
Understanding Your Cytometer
Click the button on the upper right of the area, the following "Statistics Setting" window
will display, the options are: Mean, CV, Median, Min, Mode and Gmean.。
Select the statistic items; use the "Up", "Down", "Top" and "Bottom" buttons to adjust order of
the items, and then click "OK", the selected items will be displayed in the statistics area by the
order.
Copy statistics
Use the [Ctrl] or [Shift] on the keyboard to select the statistics to be copied, and then press [Ctrl]
+ [C] to copy the result.
The copied result can be pasted to Office software.
Send to report
Click the button on the upper left of the statistics area, the button will turn to , and the
results will be sent to report. If contents of the statistic area change, the contents of the report
screen will change accordingly.
Click the button again, it will turn back to , and the results will not be sent to report.
2-37
Understanding Your Cytometer
2.7.1 About
Click the button, and select "About" in the pull-down menu to check the version and
configuration information.
Click the button, and select "Register for other computer" in the pull-down menu to
authorize installation of the software on other PCs. Refer to 4.4.2 Non-local Register.
2-38
Understanding Your Cytometer
NOTE
Store and use the reagents as instructed by instructions for use of the
reagents.
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 Reagent
SHEATH FLUID
The SHEATH FLUID is an electric conducting solution formulated to form sheath flow in the
process of cell measurement. It‘s used on Mindray BriCyte E6 Flow Cytometer with light
scatter and fluorescent applications.
CLEANING SOLUTION
The CLEANNING SOLUTION serves as a cleaning agent on Mindray BriCyte E6 Flow
Cytometer. It is an alkaline solution composed of sodium hypochlorite. It is used to wash the
fluidic system of the cytometer.
2-39
Understanding Your Cytometer
2-40
3 Understanding the System
Principles
3.1 Introduction
The BriCyte E6 Flow Cytometer is intended for cell differentiation and characteristic analysis
as well as absolute counting.
3-1
Understanding the System Principles
3-2
Understanding the System Principles
3-3
Understanding the System Principles
3-4
Understanding the System Principles
2-Laser, 4-Color
The standard configuration of the cytometer is 2-laser, 4-color. Apart from FSC and
SSC , there are 4 fluorescence channels, which are intended for dyes such as FITC, PE and
PerCP excited by the 488nm blue laser, and APC excited by the 638nm red laser. The
fluorescences excited by the red and blue lasers are separated in space to reduce interference.
See the following figure for the optical layout.
2-Laser, 5-Color
2-laser, 5-color configuration has one more fluorescence channel for the dye of PE-Cy7
excited by the 488nm blue laser than the 2-laser, 4-color configuration. The cytometer with
2-laser, 4-color configuration can be upgraded to 2-laser, 5-color configuration easily by adding
filter, mirror and PMT assembly to the corresponding position. See the following figure for the
optical layout.
3-5
Understanding the System Principles
2-Laser, 6-Color
2-laser, 6-color configuration has two more fluorescence channels than the 2-laser, 4-color
configuration, which are intended for dyes of PE-Cy7 excited by the 488nm blue laser and
APC-Cy7 excited by the 638nm red laser. Likewise, the cytometer with 2-laser, 4-color
configuration can be upgraded to 2-laser, 6-color configuration easily by adding filters, mirrors
and PMT assemblies to the corresponding position. See the following figure for the optical
layout.
3-6
Understanding the System Principles
3-7
Understanding the System Principles
Signal identification
The intensity of optical signal determines height H of the electric pulse, and the moving
duration of the particle in the beam spot determines width W of the pulse, therefore the total
scatter or fluorescence (intensity and time) determines the area A (intensity and duration) of
the pulse, as shown in the following figure.
3-8
4 Installing Your Cytometer
4.1 Introduction
WARNING
Installation of the instrument by people not authorized or trained by the
manufacturer may lead to human injury or instrument damage. Do not install
your system without the presence of Mindray-authorized personnel.
The installation, authorization, upgrade and modification of the cytometer
and software must be performed by Mindray-authorized personnel.
The cytometer is checked and packed with care before it is shipped from the factory.
International symbols and special handling instructions tell the carrier how to treat this
cytometer. When you receive your cytometer, 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 Cytometer
the reagent containers must be placed within 1.0m above or below the cytometer;
The table (or the floor) where the cytometer is placed shall be able to withstand at least
90kg of weight.
Parameter Requirement
Power supply 100V-240V~ , 50Hz/60Hz
Voltage fluctuation range ±10%
Power 500 VA
WARNING
Make sure the instrument is properly grounded.
Before turning on the cytometer, make sure the input voltage meets the
requirements.
4-2
Installing Your Cytometer
CAUTION
Using pinboard may bring the electrical interference and the analysis results
may be unreliable. Please place the cytometer near the electrical outlet to
avoid using the pinboard.
Use the power cord provided by the manufacturer. Using the power cord
other than provided by the manufacturer may lead to instrument damage or
unqualified smear output.
The environment shall be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.
Do not place the cytometer in direct sunlight or in front of a source of heat or drafts.
4-3
Installing Your Cytometer
WARNING
Installation of the instrument by people not authorized or trained by the
manufacturer may lead to human injury or instrument damage. Do not install
your cytometer without the presence of Mindray-authorized personnel.
The instrument is supposed to be moved by several people together
because of its weight. Safety procedures should be followed and applicable
tools should be used, in order to prevent from human injury.
When the instrument is waiting for service, it is suggested that sterilize and
clean the potentially bio-hazardous parts (instrument surface, sample
probe, etc.), in order to reduce the risk of bio-hazard or other hazards while
transporting or servicing t.
After being idle for a long time,moved or transported, the performance of
the cytometer must be verified before it can be used again. Contact
authorized personnel of Mindray for installation and debug if necessary.
CAUTION
After the autoloader is installed (if configured), do not lay too much
pressure to it or transport the cytometer by holding the autoloader.
Installation of unauthorized software on the PC or using the PC for any
unintended purposes may impact stability of the system or result in
incorrect data. Please only use the external PC for sample analysis and
related purposes.
While copying files to a USB storage device, do not pull out the device
before the operation is completed; otherwise, the storage device or the PC
may be damaged.
4-4
Installing Your Cytometer
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according
to government regulations.
The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.
If 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.
4-5
Installing Your Cytometer
4-6
Installing Your Cytometer
In order to use the MRFlow software installed on the PC, it shall be registered by either of the
following 2 ways: local register (connecting to the cytometer) and non-local register
(disconnecting to the cytometer).
NOTE
After installation of the MRFlow software, authorization information shall be
obtained from the cytometer; otherwise the software cannot be used as
normal.
Each cytometer may authorize installation of the MRFlow software on 3 PCs.
If you need authorization for more PCs, please Contact Mindray Customer
Service Department or your local distributor.
After getting authorization, the cytometer may not be connected for the
authorization check to run the MRFlow software.
If network card (including virtual network card)of the PC is changed after
getting authorization, the registered information turns invalid, and software
register shall be performed again.
4-7
Installing Your Cytometer
When running the MRFlow for the first time, registration of the software will be done
automatically. If auto registration fails, the following dialog box will display.
Make sure the flow cytometer is on and properly connected to the PC and the flow cytometer is
OK (the IP address here is IP of the cytometer, which is 10.0.0.2 by default), and then click the
―Register‖ button.
NOTE
If the software register still fails, please Contact Mindray Customer Service
Department or your local distributor.
1. When running the MRFlow for the first time after the installation, the following dialog box
will display.
4-8
Installing Your Cytometer
2. Turn on another PC that is connected to the flow cytometer, click the ―About‖ button on the
screen of the MRFlow software that has been registered, and select ―Non-local Register‖
from the pull-down menu, the ―Software Register‖ dialog box will display.
3. Enter the registration license displayed in step 1 into the ―Registration license‖ dialog box,
and then click ―Register‖, the message ―Connecting the flow cytometer, please wait…‖.
4-9
Installing Your Cytometer
NOTE
Make sure the connection of the PC and flow cytometer is OK, and the
host IP address is correct; otherwise the non-local register will fail.
4. Select the save directory of the registration file from the ―choose directory‖ window, and
then click ―Save‖ to generate the registration file.
5. Find the registration file named by the ―Registration Code‖ under the specified directory,
as the following figure shows.
4-10
Installing Your Cytometer
6. Send the registration file to the PC to be registered with proper method (storage device,
network transmission), and then click the ―Service Register‖ button, the message ―Please
send the registration code to Mindray Customer Service Department, and then import the
registration file returned by our service engineer to finish software register‖ will display.
7. Click the ―Load Registration File‖ button to import the registration file (.license), and then
click ―Register‖ to finish software registration.
4-11
Installing Your Cytometer
4-12
5 Customizing the Cytometer
Software
5.1 Introduction
This flow cytometer 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.
5-1
Customizing the Cytometer Software
5.2 Setup
You may set up the following functions in the "Setup" program.
Host Setup
Graph Parameters
User Management
Communication Setup
Print Setup
Template Management
Lab info.
Reagent Setup
Preference
After modifying setting in each setup screen, you may switch the screen to save the change,
the following dialog box will display.
Click "Yes" to save the setting, close the dialog box and enter the selected screen (if selected).
Click "No" to close the dialog box and enter the selected screen (if selected) without saving the
setting.
Click "Cancel" to close the dialog box and stay in the current screen without saving the setting.
IP address
Channel
Standby
Absolute count calibration factor (%)
5-2
Customizing the Cytometer Software
IP address
Click the "IP" text box, and enter the correct IP address of the cytometer, or click ―Auto detect
cytometer IP‖.
Channel
Click the "Labels" text box to set up the names of the FL1-6 channels, the names will be used
as default channel names of sample analysis.
Click the text box to enter the autoloading view time after each tube directly, or drag the slider
the set up the time, the range is 0~-30 seconds.
Standby
Click the text box to enter the system idle time before entering standby mode directly, or drag
the slider the set up the time, the range is 5~30 minutes.
Click the text box to enter the absolute count calibration factor (%) directly, or drag the slider to
5-3
Customizing the Cytometer Software
a major component has been changed (flow cell, sample probe, flow sensor);
the absolute count results of quality control indicate there may be a problem.
To ensure accuracy of the analysis results, absolute result calibration with fresh blood shall be
done when necessary.
Before calibration, make sure the cytometer is in normal working state and its performance
(Carryover, resolution of Forward and Side scatters) meets the requirements of the
specifications (See Appendix B.9 )
3. Select ―Enable absolute count‖ on the BriCyte E6, and complete 3 lymphocyte absolute
counts using high flow rate (See 6.8 Running Samples - Manual Loading or 6.9 Running
Samples - Auto Loading). The duration of each count is 1 min, and the mean of the 3
results will be used as the ―Measured Mean‖ of the calibration.
4. Check the current absolute count calibration factor in the ―Setup‖ – ―Host Setup‖ screen,
record the factor as ―Current Calibration Factor‖, and then calculate the new calibration
factor using the following equation:
5. Exit the screen, and click ―Yes‖ in the ―Setting has been modified, save the change?‖
dialog box.
1. Prepare a normal fresh blood sample. Aspirate exactly 50μL blood sample and add it to
the bottom of a BD TruCOUNT tube (make sure the sample is not spilled on the tube
wall).
5-4
Customizing the Cytometer Software
2. Add exactly 450μL 1× LYSING SOLUTION to the same tube, and then place the tube
on a vortex mixer to rotate and mix it slightly. When the sample is well mixed, incubate
the sample for 15min at room temperature (20℃~25℃) and in a place away from light.
3. Create a custom template with correctly gated population of the TruCOUNT Beads on
the BriCyte E6 (for details, refer to 6.7 Creating Templates).
4. Select ―Enable absolute count‖ and set the dilution ratio to 1:10. Complete 3 absolute
counts using high flow rate (See 6.8 Running Samples - Manual Loading or 6.9 Running
Samples - Auto Loading). The duration of each count is 1 min, and the mean absolute
count results of TruCOUNT Beads (events/μL), of the 3 runs, will be used as the
―Measured Mean‖ of the calibration.
5. Find the Manufacturer- defined value of Beads (of this lot) on the outer packing of the
BD TruCOUNT tube, and calculate the ―Reference value‖
In the equation, 500 is the sample volume 500μL, and the unit of the Reference Beads
Concentration is events/μL.
6. Check the current absolute count calibration factor in the ―Setup‖ – ―Host Setup‖ screen,
record the factor as ―Current Calibration Factor‖, and then calculate the new calibration
factor using the following equation:
7. Exit the screen, and click ―Yes‖ in the ―Setting has been modified, save the change?‖
dialog box.
If the new calibration factor is outside the valid range indicated on the software screen, then
the calibration factor is invalid. In this case, you should find out the reason (the sample is not
well mixed or prepared, misoperation, etc.) and then perform calibration again.
NOTE
The calibration factor entered must be within the range 50%~150%. If correct
absolute count cannot be obtained after adjusting the calibration factor,
please contact Mindray Customer Service Department or your local
distributors.
5-5
Customizing the Cytometer Software
Click the check boxes to enable the mix settings for autoloading model.
Click the text box to enter the initial mix time before starting the carousel or the interim mix time
after each tube directly, or drag the slider the set up the time, the range is 3-25 seconds.
Histogram Smooth
Contour setup
Histogram Smooth
Click the check box to enable or disable display of population percentage in plots.
Background of Histogram
Click the tag of "Background of Histogram", the following "Color" dialog box will display.
5-6
Customizing the Cytometer Software
Contour setup
Click the "Contour line number" pull-down list to select contour line number.
General User
5-7
Customizing the Cytometer Software
Changing password
The current user logged in can modify his/her own password.
1. Select the current user from the table, and then click ―Change Password‖.
3. Click ―OK‖ to save the change and close the dialog box.
NOTE
The password cannot be null and up to 12 characters can be entered.
Administrator
5-8
Customizing the Cytometer Software
Changing password
The current user logged in can modify his/her own password.
1. Select the current user from the table, and then click ―Change Password‖.
3. Click ―OK‖ to save the change and close the dialog box.
NOTE
The password cannot be null and up to 12 characters can be entered.
5-9
Customizing the Cytometer Software
2. Enter the "User ID", "Name" and "Password" in the text boxes.
3. Select one of the following access levels from the ―User group‖ pull-down list:
Administrator
Operator
4. Click the ―Yes‖ radio button to display the User ID on the login screen,
or
6. Click "OK" to save the change and close the dialog box.
NOTE
The user ID cannot be null and up to 12 characters can be entered.
5-10
Customizing the Cytometer Software
2. Modify the "User ID", "Name" and /or "Note" by editing the text in the box(es) as
needed. The default administrator user ID "Admin" cannot be edited.
5. Click ―OK‖ to save the change and close the dialog box.
NOTE
The user ID cannot be null and up to 12 characters can be entered.
Reset password
Select a user and then click the ―Reset password‖ button to reset the password to be the same
as its user ID.
NOTE
An administrator can reset the password of all users at the operator and
administrator access level.
5-11
Customizing the Cytometer Software
Delete user
Select a user and then click ―Delete‖ to delete it.
NOTE
The current user logged in cannot be deleted.
Network Setup
Protocol Setup
Transmit mode
Click the check box "Terminal Software as Server" to use terminal software of the PC as server.
When this function is enabled, the terminal software of the PC is used as server; if it is not
enabled, the software is used as client end.
Network Setup
Click the "IP address" and "Port" text boxes and enter the correct settings.
When "Terminal Software as Server" is disabled, the "IP address" here will be adopted,
otherwise, it will be ignored
Protocol Setup
5-12
Customizing the Cytometer Software
Protocol type
Click the pull-down list to select communication protocol, the options are:
HL7
ASTM
Version
Click the pull-down list to select version No..
Transmit Mode
Click the check boxes to enable the "2-Way LIS/HIS" and "Auto transmit after check" functions.
Click the pull-down lists to select the panels for communication with LIS/HIS.
Panels setup for LIS/HIS will be used when LIS/HIS is enabled. Once panel information of the
current sample is obtained from LIS/HIS, MRFlow will select the panel template automatically,
according to panels setup here. They are Mindray templates by default, and can only be
changed to custom templates which should include parameters of the same abbreviations with
Mindray templates.
Print Setup
5-13
Customizing the Cytometer Software
Print Setup
Click the check boxes to enable the "Print after Validation (Printing operation is not allowed
before validation)‖ and "Autoprint after Valiation" functions.
5.2.6 Templates
In the "Templates" screen, you may set up the following information:
Delete template/group
In the "Templates" screen, Custom templates and saved Mindray templates will be displayed,
other than the default Mindray templates and QC templates.
Select the template to be edited, click in its cell to edit the template name.
All customized templates are in the "Custom templates" group if there is no custom group, as
5-14
Customizing the Cytometer Software
Adjusting position
Click and hold the target group, and then drag it horizontally to the desired position.
Delete template/group
Delete template
Select the template to be deleted, and then click the "Delete" button to delete it.
Delete group
Select the group to be deleted, and then click the "Delete" button to delete it.
NOTE
Once a group is deleted, all templates of the group will be deleted too, and
cannot be restored.
The“Mindray templates” and "Custom templates" are default groups which
cannot be deleted.
Field
LOGO
The fields and logo here will be sent to the ―Report‖ screen automatically for report design.
In the ―Report‖ screen, you can only insert and delete the fields and logo, other than modify
5-15
Customizing the Cytometer Software
them.
Field
LOGO
1. Click the " (browse)" button, the following window will display.
2. Select the source of logo picture, the supported file types are jpg, jpeg, bmp, png, tif
and tiff.
5-16
Customizing the Cytometer Software
NOTE
Maximum pixel of the logo picture allowed is 150*150.
Cutoff Value
Click the‖ HLA-B27 Lot NO.‖ text box to enter lot No. of the reagent to be used.
Click the ―Cutoff value‖ text box to enter the value directly or drag the slider of the text box to
set up the value.
The cutoff value can be obtained from the package insert of Mindray HLA-B27 reagent kit,
which is dedicated for the Lot. It will be applied to algorithm settings for HLA-B27-Auto Mindray
template.
NOTE
The “HLA-B27 Lot NO.” and cutoff value must be entered correctly in the
“Reagent Setup” screen, otherwise, incorrect results may be otained when
running samples of HLA-B27-Auto Mindray template.
Auto-compensation Settings
5-17
Customizing the Cytometer Software
signal H and W are folded; when H is selected, signal H of all channels in the plot axis
pull-down list are fully expanded, signal A and W are folded; when A&&H is selected, signal A
and H of all channels in the plot axis pull-down list are fully expanded, signal W is folded.
Click the check boxes to allow modifications to the "Technologist‖ field in "Sample"—"Sample
Info." Screen (Technologist information is auto generated by the system, and cannot be edited
by default).
Auto-compensation Settings
Click the “Sample type”radio buttons to set up sample type to Cells or Beads (Select ―Cells‖
when cells or biological samples are used for auto-compensation, or ―Beads‖ when micro
particles are used).
Click the “Dimension”radio buttons to set up channel parameters to A(area) or H(height)
(When A is selected, parameter A is displayed for all channels, and biexponential mode is
applied to all FL channels in the ―Auto_Compensation‖ panel; When H is selected, parameter
H is displayed for all channels, and log mode is applied to all FL channels in the
―Auto_Compensation‖ panel).
5-18
Customizing the Cytometer Software
Click the check boxes to include ―Unstained‖ tube in ―Auto_Compensation‖ panel and select
required FL channels.
NOTE
Modificaitons to “Auto-compensation Settings” will not be applied to
already existed samples.
5-19
Customizing the Cytometer Software
5-20
6 Operating Your Cytometer
6.1 Introduction
This chapter provides step-by-step procedures for operating your flow cytometer on a daily
basis.
A flow chart presenting the common daily operating process is shown below.
Initial Checks
Switch on the
cytometer and open
MRFlow software
Power on
Daily Quality
Control
Sample
Preparation
Run Samples
Analysis Results
6-1
Operating Your Cytometer
All the samples, controls, wastes and areas contacted by 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.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.
The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.
If 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, hairs and hands away from the moving parts to avoid
injury.
If any of the pipes or fluidic components are worn out, stop using the
cytometer and contact Mindray customer service department immediately
for inspection or replacement.
When the instrument is waiting for service, it is suggested that you sterilize
and clean the potentially bio-hazardous parts (instrument surface, sample
probe, etc.), in order to reduce the risk of bio-hazard or other hazards while
transporting or servicing t.
NOTE
Use the reagents specified by the manufacturer only. Store and use the
reagents as instructed by instructions for use of the reagents.
Check if the reagents are properly connected before using the cytometer.
6-2
Operating Your Cytometer
6-3
Operating Your Cytometer
1. Place the power switch at the back of the cytometer in the ON position (I). The power
indicator light will be on.
2. Start up the PC and turn on the monitor. After the operation system is started, double
click the " MRFlow" icon to run the supporting software installed.
4. Enter the correct user ID and password, and then click "OK" to enter the "Work Center"
screen.
6-4
Operating Your Cytometer
NOTE
The default user ID and password for administrator are both "Admin".
The user ID and password may be consisted of 1-12 letters, and the
password cannot be null.
The system opens different function for the user according to the user
level. The user level depends on the user ID and the password when
the user logs in.
5. The system performs initialization, countdown and warm-up; during the startup process,
the indicator in the "Control Panel" flickers in green.
6. The following dialog box will display after initialization and warm-up completes, and the
indicator in the "Control Panel" is in static green, the startup procedure finishes.
NOTE
Time needed for startup initialization depends on how the cytometer
was previously shut down.
You may start up the cytometer first or run the software first during the
startup procedure.
Before running the software, make sure the power cord of the PC is
properly connected with the cytometer. If the cytometer and the PC are
not connected, startup initialization will not be performed.
Only 1 login user is allowed at a time, to switch user, you need to log
out the current user by clicking the "Logout" button in the quick icon
area, and then enter user ID and password of the new user into the
login dialog box and click "OK" to log in the software system again.
When the cytometer is running, or the printing or exporting task is
ongoing, you cannot log out the current user.
6-5
Operating Your Cytometer
6-6
Operating Your Cytometer
All the samples, controls, wastes and areas contacted by 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.
WARNING
Avoid direct contact with patient samples.
CAUTION
Do not re-use disposable products..
NOTE
Be sure to use clean medical materials.
Be sure to use the Mindray-specified disposable products including 12×75
mm tubes for flow cytometer, centrifugal tubes, etc.
Follow your laboratory protocols to collect and prepare the samples, and
prevent impurity substances from getting into the samples. Otherwise, the
instrument may yield inaccurate results or malfunction.
6-7
Operating Your Cytometer
Make sure thickness of the label and the adhesive is no more than 0.36mm, and the tube with
barcode label can be taken out from and placed back to the carousel or tube holder easily.
1. Process the sample with proper method (mechanical method, enzymatic digestion,
chemical treatment, etc.), and rinse it with proper buffer solution to make it into a
single-cell suspension.
2. Filter the single-cell suspension with filter screen, to ensure the particle size of the
suspension is no more than 50μm.
NOTE
Blood samples are single-cell suspensions, thus they do not need to be
processed.
Staining
1. Stain the single-cell suspension with fluorescence dyes as instructed by the package
insert of the staining reagent.
2. Remove some interfering cells with the lyse/no-wash or lyse/wash method.
3. After being mixed thoroughly, the processed sample is ready for analysis on the flow
cytometer.
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Operating Your Cytometer
NOTE
The sample processed with the lyse/no-wash method must be diluted by the
same lysing solution, other buffer solutions are not permitted.
The sample processed with the lyse/wash method shall be mixed with
fixative and stored properly if it cannot be analyzed within 2 hours.
Be sure to mix any sample that has been prepared for a while before running
it.
6-9
Operating Your Cytometer
Click the " (Add Sample)‖ or " (Add Sample (Batch))‖ button, one or more new
sample records will be added at the bottom of the worklist, you may enter the sample
information manually or by scanning the barcode.
NOTE
The basic sample information in the worklist must be entered before sample
analysis.
The sample and patient information in the “Sample” screen may be entered
before or after sample analysis.
Abnormal shutdown will result in loss of sample information that is not yet
saved.
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Operating Your Cytometer
NOTE
25 characters are allowed for sample ID maximally (including prefix).
Click the "Panel" pull-down list to select the desired panel template. Defined number of tubes
will be included in the sample according to the panel template.
If your desired panel template is not in the pull-down list, you may edit one of the templates
available or create a new one, see 6.7 Creating Template for details.
Click the " (add tube)" button to add required number of tubes under the current sample.
Enter or edit the name of each tube in the "Tube Name" text box.
NOTE
16 tubes can be added at most.
Click the "Tube Position" cell, a graphic carousel will display, click the arrow buttons by the two
sides of the carousel ID to go to the target carousel; click a position ID. to assign the tube
position, the selected position will turn dark.
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Operating Your Cytometer
The tube position generation rule is auto increase. The new tube position ID will increase by 1
on the basis of the previous one.; if the previous tube position ID is 40, then the position ID of
the new tube is 1.
6-12
Operating Your Cytometer
Sample Information
The left column of the "Sample Info." screen lists the extended sample information, including
sample type, collection time, and receive time.
The entry time, validator, check time and Analysis info.(only available for Mindray panels)are
auto generated by the system, and cannot be edited.
‖Analysis info.‖ mainly displays errors and flags, and is only available for Mindray panels. For
more information, refer to 6.11.2Sample Analysis- Flags with Mindray panels.
Technologist information is auto generated by the system, and can only be edited when
the modification permission is enabled in ―Setup‖-―Preference Setup‖ page.
Sample type
Enter sample type in the "Sample type" text box.
Collection time
Click the pull-down list in the "Collection time" box and select the date from the date control.
Receive time
Click the pull-down list in the "Receive time" box and select the date from the date control.
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Operating Your Cytometer
NOTE
The receive date/time cannot be earlier than the collection date/time。
The collection and receive date/time cannot be earlier than current system
date/time.
Clinician
Patient Information
The right column of the "Sample Info." screen lists the patient information; you may edit patient
name, patient type, gender, date of birth, age, payer, department, hospital zone, bed No.,
clinical diagnosis and doctor in charge.
Patient type
Enter patient type in the "Patient type" text box.
Patient ID
Enter the medical record number in the "MR number" box.
Patient name
Patient gender
Enter patient gender in the "Gender" text box or select it from the pull-down list.
Date of birth
Enter patient's date of birth in the "Date of birth" box, or click the pull-down list to select the
date of birth from the date control.
Patient‘s age
The cytometer provides 4 ways for you to enter the patient‘s age – in years, in months, in days
and in hours. The first way is designed for the patients no younger than one year; the second
for the infant patients one month to one year; the third for the neonatal no older than one
month, and the fourth for the neonatal no older than 24 hours. You may choose 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
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Operating Your Cytometer
months, in days and in hours, and you may enter the patient age in the box followed by the age
unit.
NOTE
If the patient's date of birth is entered, his/her age will be calculated
automatically, and the age field will gray out and cannot be edited.
Payer
Enter payment type in the "Payer" text box.
Department name
Ward
Enter the name of the ward into the ―Ward‖ field.
Bed No.
Clinical diagnosis
Enter the clinical diagnosis result into the "Clinical diagnosis" field.
Doctor in charge
After you finish edition of the worklist, switch screen to save the information.
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Operating Your Cytometer
1. Select a sample from the worklist, and select the template "Empty" from the "Panel"
pull-down list.
2. Click the " (unfold)" button on the left of the sample ID in the worklist; you will see tube
1 under the sample.
3. Select tube 1, the following "Sample "—"Tube 1" screen will display.
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Operating Your Cytometer
4. Create new graphs (with defined gate and events) in the graph area of the screen, verify
the axes and data source(GATE) of each graph and add gates and statistics for the
graphs (see 2.6 Analysis Tools for the operations of graphs, gates and statistics).
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Operating Your Cytometer
6-18
Operating Your Cytometer
9. To enable absolute count, click ―Control Panel"—"Abs. Count" to select "Enable absolute
count" and set up the dilution ratio, within the range of 1:1~1:100.
10. Set up the stop conditions of acquisition in the "Control Panel" - "Stop Conditions" area.
The stop condition options are elapsed time (second), volume (μL) and events within the
defined gate. The combination mode of the options is "OR", which means recording will
be stopped when either of the conditions is met first.
11. Click the "Low", "Mid" or "High" radio buttons in the "Control Panel" - "Flow rate" area to
select flow rate for acquisition. You may adjust flow rate according to the events
processing speed during acquisition. (Sample flow rate: Low: about 10μL /min, Mid:
about 50μL/min, High: about 100μL/min)
12. Enter number of events in the "Control Panel" - "Events To Display" text box, or select
the number from the pull-down list to set up events to be displayed in the graphs of the
"Sample " - "Tube 1" screen.
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Operating Your Cytometer
13. After finishing setup of tube 1, click " (add tube)" button repeatedly to add as many
tubes as necessary.
14. Other tubes of the current sample inherit template of the previous tube, you may adjust
the setting by performing step 4~12.
15. After finishing all tubes of the current sample, edit report template in ―Sample‖- ―Report‖
screen. See 6.11.2 Sample Analysis - Report.
NOTE
Before finishing acquisition of samples using Mindray Templates, you may
only edit the "Abs. Count", "Stop conditions", "Events to Display" in the
“Control Panel” area, and text, parameter items & “Ref. Range” in the
“Report” Screen.
1. Select a sample from the worklist, and then select the closest Mindray template from the
" Panel" pull-down list, for example "TBNK-Auto".
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Operating Your Cytometer
2. Click the " (unfold)" button on the left of the sample ID in the worklist, you will see tube
T and tube BNK under the sample.
4. Click ―Control Panel"—"Abs. Count" to set up Dilution Ratio for absolute count. In the
"TBNK-Auto" panel, "Enable absolute count" is selected by default as the following figure
shows. Click the ―Dilution Ratio‖ text box to enter the value, within the range of
1:1~1:100. Clickin the check box to disable absolute count if necessary.
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Operating Your Cytometer
5. Set up the stop conditions of acquisition in the "Control Panel" - "Stop Conditions" area.
The stop condition options are elapsed time (second), volume (μL) and events within the
Lym gate. The combination mode of the options is "OR", which means recording will be
stopped when either of the conditions is met first..
6. Enter number of events in the "Control Panel" - "Events To Display" text box, or select
the number from the pull-down list to set up events to be displayed in the graph of the
"Sample - "T" screen.
7 Select tube BNK and adjust the settings following step 4~6.
1. Select a sample from the worklist, and then select the closest panel template from the
"Panel" pull-down list, for example a custom template named "TBNK-4C"(previously
saved by user).
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Operating Your Cytometer
2. Click the " (unfold)" button on the left of the sample ID in the worklist, you will see tube
T and tube BNK under the sample.
4. You may close, create or adjust graphs, gates and statistics of the template in the tube
"T" screen according to your needs (see 2.6 Analysis Tools for details).
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Operating Your Cytometer
6-24
Operating Your Cytometer
value, select "Manual" to enable the ―Below Zero‖ fields. The values can be adjusted
from 5 to 1048575.
9. To enable absolute count, click ―Control Panel"—"Abs. Count" to select " Enable
absolute count" and set up the Dilution Ratio, within the range of 1:1~1:100.
10. Set up the stop conditions of acquisition in the "Control Panel" - "Stop Conditions" area.
The stop condition options are elapsed time (second), volume (μL) and events within the
defined gate. The combination mode of the options is "OR", which means recording will
be stopped when either of the conditions is met first.
11. Click the "Low", "Mid" or "High" radio buttons in the "Control Panel" - "Flow rate" area to
select flow rate for acquisition. You may adjust flow rate according to the events
processing speed during acquisition. (Sample flow rate: Low: about 10μL /min, Mid:
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Operating Your Cytometer
12. Enter number of events in the "Control Panel" - "Events To Display" text box, or select
the number from the pull-down list to set up events to be displayed in the graphs of the
"Sample " - "Tube 1" screen.
13. Select tube BNK and adjust the settings following step 4~12.
14. Click the " (add tube)" button repeatedly to add as many tubes as necessary.
15. The added tubes inherit template of the previous tube and you may adjust the setting by
performing step 4~12.
16. After finishing all tubes of the current sample, edit report template in ―Sample‖- ―Report‖
screen. See 6.11.2 Sample Analysis - Report.
1. Select the sample to be saved as panel template in the worklist, Click " (save as panel
template)" in the toolbar of the "Worklist" screen, the following dialog box will display.
2. To save the template as a new custom template, verify the name of the template and then
click "OK"; the new panel template will be added to the "Custom template" group of the
"Panel" pull-down list.
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Operating Your Cytometer
3. The edited Mindray template and QC template can be saved as a custom template or
Mindray template. To save the template as Mindray template, verify the name and select
the "Save as Mindray template" check box, and then click "OK"; the new template will be
added to the ―Mindray templates‖ group of the "Panel Template" pull-down list.
4. If the name of the new template has been used already, the following dialog box will
display. Click "Yes" to overwrite the previous template with the same name; click "No" to
rename the new template.
NOTE
The templates in "Empty", "Mindray templates" and “QC templates” groups
are default panel templates, which cannot be overwritten.
6-27
Operating Your Cytometer
All the samples, controls, reagents, wastes and areas contacted by 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.
WARNING
The sample probe may contain biohazardous materials. Exercise caution to
avoid contact with the probe when working around it.
Keep your clothes, hairs and hands away from the moving parts to avoid
injury.
CAUTION
Do not reuse disposable products.
NOTE
Be sure to avoid spillage of liquid caused by excessive liquid volume in the
tube.
Be sure to prepare samples with proper reagents and procedures in
accordance with the panel selected in the worklist.
Mindray panels are designed for samples prepared with Mindray-specified
antibody reagents and Lysing solution (Refer to Mindray Flow Product
Catalogs). Non-specified reagents may cause incorrect auto-gating results
and absolute counts, and extra calibration of absolute count and adjustment
of gates will be necessary in such cases.
6-28
Operating Your Cytometer
12x75mm tube
After mixing the sample thoroughly, insert the tube vertically to the manual loading tube holder.
Make sure the tube fall to the bottom of the holder, and can be taken out and put back easily.
Centrifugal tube
1. Push the centrifugal tube adapter into the manual loading tube holder according to the
following figure.
2. After mixing the sample thoroughly, uncap the centrifugal tube; put it into the adapter as
the following figure shows.
1. Select the first tube to be run in the worklist, the default "Sample " screen of the panel
6-29
Operating Your Cytometer
displays; the following figure is the "Sample" screen of the T/B/NK-Auto panel.
2. Click the " (record)" button in the "Control Panel" area; the cytometer will start acquiring
and recording.
3. The cytometer indicator light flickers in green during acquisition, and a green arrow will
display by the left of the current tube in the worklist.
4. The acquisition status area on bottom left of the screen shows the following information in
real time: Elapsed Time, Gated/All Events, Process Rate, Abort Rate, and Aspirated
Sample Volume.
5. During the run, to stop running, click the " (stop)" button.
6. After the run, the cytometer indicator light turns into static green.
7. Repeat the steps above until data has been recorded for all tubes.
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Operating Your Cytometer
NOTE
If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
the error information area; see 9 Troubleshooting for solutions.
Before finishing acquisition of samples using Mindray Templates, you may
only edit the “Abs. Count”, “Stop conditions”, “Events to Display” in the
“Control Panel” area, and text, parameter items & “Ref. Range” in the
“Report” Screen.
If absolute count is enabled, the "High" or “Mid” flow rate shall be used, and
the duration of recording shall be more than 10 seconds, or the results may
be inaccurate.
Review results of Mindray panels after acquisition and adjust gates if there
are any flags about auto-algorithm or inaccurate differentiation results.
To edit Mindray templates after acquisition, see 6.11 Analyzing Results.
1. Select the first tube to be run in the worklist, the default "Sample " screen of the panel
displays.
2. Click the " (acquire)" button in the "Control Panel" area, the cytometer will start
acquiring sample. The cytometer indicator light flickers in green during acquisition.
3. A green arrow will display by the left of the current tube in the worklist screen.
4. The acquisition status area on bottom left of the screen shows the following information
in real time: Elapsed Time, Gated/All Events, Process Rate, Abort Rate, and Aspirated
Sample Volume.
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Operating Your Cytometer
8. Adjust voltage, threshold and compensation repeatedly, move the gate and click the
" (refresh)" button in the toolbar to position populations in the graph properly.
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Operating Your Cytometer
10. To enable absolute count, click ―Control Panel"—"Abs. Count" to select " Enable
absolute count" and set up the dilution ratio, within the range of 1:1~1:100.
11. Set up the stop conditions of acquisition in the "Control Panel" - "Stop Conditions" area.
The stop condition options are elapsed time (second), volume (μL) and events within the
defined gate. The combination mode of the options is "OR", which means recording will
be stopped when either of the conditions is met first.
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Operating Your Cytometer
12. Click the "Low", "Mid" or "High" radio buttons in the "Control Panel" - "Flow rate" area to
select flow rate for acquisition. You may adjust flow rate according to the events
processing speed during acquisition. (Sample flow rate: Low: about 10μL /min, Mid:
about 50μL/min, High: about 100μL/min.)
13. Enter number of events in the "Control Panel" - "Events To Display" text box, or select
the number from the pull-down list to set up events to be displayed in the graphs of the
"Sample " - "Tube 1" screen.
14. Click the " (record)" button in the toolbar, the cytometer starts recording; when the
stop condition is reached, recording will be stopped automatically.
15. During the process, to stop running, click the "(stop)" button in the "Control Panel" area.
16. ,After the run, the cytometer indicator light turns into static green.
17. Repeat the steps above until data has been recorded for all tubes.
NOTE
If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
the error information area; see 9 Troubleshooting for solutions.
If absolute count is enabled, the “High” or “Mid” flow rate shall be used, and
the duration of recording shall be more than 10 seconds, or the results may
be inaccurate.
To edit custom panel templates after finishing acquisition, see 6.11
Analyzing Results.
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Operating Your Cytometer
All the samples, controls, reagents, wastes and areas contacted by 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.
WARNING
The sample probe may contain biohazardous materials. Exercise caution to
avoid contact with the probe when working around it.
Keep your clothes, hairs and hands away from the moving parts to avoid
injury.
Do not try to pull the autoloader door open forcefully when it is locked.
CAUTION
Do not reuse disposable products.
NOTE
Be sure to avoid spillage of liquid caused by excessive liquid volume in the
tube.
Be sure to prepare samples with proper reagents and procedures in
accordance with the panel selected in the worklist.
Carousels are used for loading tubes in autoloading model. Before the carousels are put to use,
they must be labeled and set up in the following procedures, in order to be identified correctly
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Operating Your Cytometer
by the cytometer.
There are four ID holes in the bottom of each carousel, which determined the carousel ID by
the combination mode of their state (open or blocked). Pull out one or more plugs of the holes,
and paste the corresponding carousel ID label on the top of the central shaft.
See the following figures to learn about ID holes and carousel ID labels.
The autoloading model supports 2 modes, which are batch mode and single-tube mode. You
may switch the mode by clicking the ― (mode) ―button in the "Control Panel" area.
6-36
Operating Your Cytometer
WARNING
Each tube must be exactly in the carousel position specified in the worklist
to avoid incorrect results.
1. Click "Setup"—"Host Setup" to edit result validation time and mix settings.
2. Click ―Work Center‖ and then click ―Yes‖ in the Save dialog box to save the settings.
3. Make sure the mode displayed in the "Work Center" - "Control Panel" area is batch
mode as shown in the following figure.
4. Insert the tubes to be run vertically into the carousel position specified in the worklist as
instructed in the following figure. Make sure the tube fall to the bottom of the position,
and can be taken out and put back easily.
5. Open the autoloader door to install the carousel properly. Insert central shaft of the
autoloader in the central hole of the carousel, and turn the carousel and then fix it until its
positioning hole matches the autoloader positioning pin. See the following figure.
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Operating Your Cytometer
Running Samples
1. Select the first tube to be run in the worklist, the default "Sample " of the panel will
display; the following figure is the ―Sample‖ screen of the T/B/NK-Auto panel.
6-38
Operating Your Cytometer
2. Click the " (start autoloader)" button in the "Control Panel" area, the cytometer will
run samples from the initial position automatically.
3. The autoloader door is locked tight and the cytometer indicator light flickers in green
during the r.
4. The "Carousel Status" graph will display on the screen, and a green arrow appears by the
left of the current tube in the worklist.
5. The acquisition status area on bottom left of the screen shows the following information in
real time: Elapsed Time, Gated/All Events, Process Rate, Abort Rate, and Aspirated
Sample Volume.
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Operating Your Cytometer
6. The cytometer searches downwards for tubes to be run in the worklist; tubes that have
been previously processed will be skipped. The loading finishes when there are no more
tubes to left in the worklist.
7. During the autoloading process, to stop acquisition of the current tube, click the
" (stop)" button in the "Control Panel" area. To skip to the next tube manually, click
" (next tube)" button, acquisition of the current tube will be stopped; the carousel will
move to the next tube to be run. To manually end autoloading process of the carousel,
click the " (stop carousel)" button in the "Control Panel" area, the carousel will stop
loading and be reset.
8. When all tubes have been run, the carousel will be reset, and the cytometer indicator light
will turn to static green; by then it is safe to open the autoloader door to take out the tubes
or remove the carousel.
NOTE
If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
the error information area; see 9 Troubleshooting for solutions.
Before finishing acquisition of samples using Mindray Templates, you may
only edit the “Abs. Count”, “Stop conditions”, “Events to Display” in the
“Control Panel” area, and text, parameter items & “Ref. Range” in the
“Report” Screen.
If absolute count is enabled, the “High” or “Mid” flow rate shall be used, and
the duration of recording shall be more than 10 seconds, or the results may
be inaccurate.
Review results of Mindray panels after acquisition and adjust gates if there
are any flags about auto-algorithm or inaccurate differentiation results.
1. Select the first tube to be run in the worklist, the default "Sample " of the panel will
display.
6-40
Operating Your Cytometer
2. Click the " (start autoloader)" button in the "Control Panel" area, the cytometer will
run sample from the initial position automatically.
3. The autoloader door is locked tight and the cytometer indicator light flickers in green
during acquisition.
4. The "Carousel Status" graph will display on the screen, and a green arrow appears by
the left of the current tube in the worklist.
5. The acquisition status area on bottom left of the screen shows the following information
in real time: Elapsed Time, Gated/All Events, Process Rate, Abort Rate, and Aspirated
Sample Volume.
6. The cytometer will start recording automatically. To adjust cytometer settings, click the
" (acquire)" button and do as follows.
6-41
Operating Your Cytometer
10. Adjust voltage, threshold and compensation repeatedly, move the gate and click the
" (refresh)" button in the toolbar to position populations in the graph properly.
6-42
Operating Your Cytometer
12. To enable absolute count, click ―Control Panel"—" Abs.Count" to select " Enable
absolute count" and set up the dilution ratio, within the range of 1:1~1:100.
13. Set up the stop conditions of acquisition in the "Control Panel" - "Stop Conditions" area.
The stop condition options are elapsed time (second), volume (μL) and events within the
defined gate. The combination mode of the options is "OR", which means recording will
be stopped when either of the conditions is met first.
6-43
Operating Your Cytometer
14. Click the "Low", "Mid" or "High" radio buttons in the "Control Panel" - "Flow rate" area to
select flow rate for acquisition. You may adjust flow rate according to the events
processing speed during acquisition. (Sample flow rate: Low: about 10μL /min, Mid:
about 50μL/min, High: about 100μL/min.)
15. Enter number of events in the "Control Panel" - "Events To Display" text box, or select
the number from the pull-down list to set up events to be displayed in the graphs of the
"Sample " - "Tube 1" screen.
16. Click the " (record)" button in the toolbar, the cytometer starts recording; when the
stop condition is reached, recording and acquiring will be stopped automatically.
17. The cytometer searches downwards for tubes to be run in the worklist; tubes that have
been previously processed will be skipped. The loading finishes when there are no more
tubes to be run in the worklist.
18. During the process, to stop acquisition of the current tube, click the " (stop)" button in
the "Control Panel" area. To skip to the next tube manually, click "(next tube)" button,
acquisition of the current sample will be stopd; the carousel will move the next tube to be
run. To manually end autoloading process of the entire carousel, click the " (stop
carousel)" button in the "Control Panel" area, the carousel will stop loading and be reset.
19. When all tubes have been run, the carousel will be reset, and the cytometer indicator
light will restore to static green; by then it is safe to open the autoloader door to take out
the tubes or remove the carousel.
6-44
Operating Your Cytometer
NOTE
If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
the error information area; see 9 Troubleshooting for solutions.
If absolute count is enabled, the “High” or “Mid” flow rate shall be used, and
the duration of recording shall be more than 10 seconds, or the results may
be inaccurate.
To edit custom panel templates after acquisition, see 6.11 Analyzing Results.
1. Make sure the mode displayed in the "Work Center" - "Control Panel" area is single tube
mode as shown in the following figure.
2. Open the tube access door on top of the autoloader; insert the tube vertically into
position 20 of the carousel. Make sure the tube fall to the bottom of the position, and can
be taken out and put back easily.
6-45
Operating Your Cytometer
Running Samples
Running Samples of Mindray Panels
1. Select the first tube to be run in the worklist, the default "Sample " screen of the panel will
display; the following figure is the "Sample ― screen of the T/B/NK-Auto panel.
2. Click the " (record)" button in the "Control Panel" area; the cytometer will start acquiring
and recording.
3. The cytometer indicator light flickers in green during acquisition, and a green arrow will
display by the left of the current tube in the worklist. The current ―tube position‖ in the
worklist changes to ―0-20‖ automatically, as the following figure shows.
4. The acquisition status area on bottom left of the screen shows the following information in
real time: Elapsed Time, Gated/All Events, Process Rate, Abort Rate, and Aspirated
Sample Volume.
5. During the process, to stop running, click the " (stop)" button.
6. After the run, the autoloader will be reset, and the cytometer indicator light will turn to
static green, .
6-46
Operating Your Cytometer
NOTE
If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
the error information area; see 9 Troubleshooting for solutions.
Before finishing acquisition of samples using Mindray Templates, you may
only edit the “Abs. Count”, “Stop conditions”, “Events to Display” in the
“Control Panel” area, and text, parameter items & “Ref. Range” in the
“Report” Screen.
If absolute count is enabled, the “High” or “Mid” flow rate shall be used, and
the duration of recording shall be more than 10 seconds, or the results may
be inaccurate.
Review results of Mindray panels after acquisition and adjust gates if there
are any flags about auto-algorithm or inaccurate differentiation results.
1. Select the first tube to be run in the worklist, the default "Sample " of the panel will
display.
2. Click the " (acquire)" button in the "Control Panel" area, the cytometer will start
acquiring sample. The cytometer indicator light flickers in green during acquisition.
3. A green arrow will display by the left of the current tube in the worklist screen.
4. The acquisition status area on bottom left of the screen shows the following information
in real time: Elapsed Time, Gated/All Events, Process Rate, Abort Rate, and Aspirated
Sample Volume.
6-47
Operating Your Cytometer
Voltage.
8. Adjust voltage, threshold and compensation repeatedly, move the gate and click the
6-48
Operating Your Cytometer
" (refresh)" button in the toolbar to position populations in the graph properly.
10. To enable absolute count, click ―Control Panel"—" Abs.Count" to select " Enable
absolute count" and set up the dilution ratio, within the range of 1:1~1:100.
11. Set up the stop conditions of acquisition in the "Control Panel" - "Stop Conditions" area.
The stop condition options are elapsed time (second), volume (μL) and events within the
defined gate. The combination mode of the options is "OR", which means recording will
be stopped when either of the conditions is met first.
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Operating Your Cytometer
12. Click the "Low", "Mid" or "High" radio buttons in the "Control Panel" - "Flow rate" area to
select flow rate for acquisition. You may adjust flow rate according to the events
processing speed during acquisition. (Sample flow rate: Low: about 10μL /min, Mid:
about 50μL/min, High: about 100μL/min.)
13. Enter number of events in the "Control Panel" - "Events To Display" text box, or select
the number from the pull-down list to set up events to be displayed in the graphs of the
"Sample " - "Tube 1" screen.
14. Click the " (record)" button in the toolbar, the cytometer starts recording; when the
stop condition is reached, recording will be stopped automatically.
15. During the process, to stop running, click the " (stop)" button.
16. After the run, the autoloader will be reset, and the cytometer indicator light will turn to
static green .
NOTE
If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
the error information area; see 9 Troubleshooting for solutions.
If absolute count is enabled, the “High” or “Mid” flow rate shall be used, and
the duration of recording shall be more than 10 seconds, or the results may
be inaccurate.
To edit custom panel templates after acquisition, see 6.11 Analyzing Results.
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1.
Select the plot to be adjusted (dot plot or density plot), click the ― (Auto tools)‖ button
2. The cursor in the graph is in hand shape; press the mouse to position a population, a
small blue square will be displayed. Drag the mouse to move the blue square.
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3. Release the mouse button when the blue square reaches the target position. The software
will calculate voltage automatically and move the center of the population to the target
position. The updated voltage will be displayed in the "Work Center" - "Control Panel" -
"Voltage & Compensation" screen.
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NOTE
The auto compensation function based on plots can achieve populations
"aligned in both horizontal and vertical directions" automatically; before
using the function, be aware:
1) The function can only be used for dual- color plots,and cannot be used
during acquisition.
2) There must be double-negative cells and single-positive cells of one
fluorescence; interference of weak positive cells is not allowed.
1.
Select the plot to be adjusted (2-color dot plot or density plot), click the ― (Auto tools)‖
2. Click the "Auto" button under "PE-FITC", fluorescence compensation will be performed
automatically, and the position and shape of cell population in the original graph will
change accordingly. After auto compensation finishes, the result will be displayed in the
"Manual" text box, the centers of populations on the lower left and right of the graph are
aligned, as the following figure shows. To optimize compensation result, click the "Manual"
text box to adjust manually.
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3. Click the "Auto" button under "FITC-PE", fluorescence compensation will be performed
automatically, and the position and shape of cell population in the original graph will
change accordingly. After auto compensation finishes, the result will be displayed in the
"Manual" text box, the centers of populations on the upper and lower left of the graph are
aligned, as the following figure shows. To optimize compensation result, click the "Manual"
text box to adjust manually.
4. After auto compensation finishes, the result of "Auto compensation" will be applied and
displayed in the "Work Center" - "Control Panel" - "Compensation" screen, as shown in
the following figure.
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1. Add one sample record in the worklist and select the template "Auto_Compensation" from
the "Panel" pull-down list.
2. Click the " (unfold)" button on the left of the sample ID in the worklist; you will see the
following tubes under the sample: Unstained, FITC, PE, PerCP, APC.
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3. Acquire the unstained control tube and adjust the voltages, threshold, flow rate and the
profile /position of the gates, to put the target populations to proper positions. Record data
with proper stop conditions.
4. Other tubes of the sample inherit the settings and ―Cells‖ gate of the current tube
automatically.
5. Record data for single-stained control tubes of FTTC, PE, PerCP, and APC subsequently.
Adjust the profile /position of the gates to put the target populations to proper positions.
6. When data has been collected for all tubes, the software will automatically calculate
spectral overlap values and fill in the compensation matrix in the ―Control Panel‖ –
―Compensation‖ page.
7. To copy the compensation matrix to tubes of other sample, refer to 6.11.1 Worklist -
Functions of Right Click (Copy/Sync)
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NOTE
To perform auto compensation based on single-stained tubes, FL channel
voltages must be the same among all tubes of the sample.
In case of "Auto_Compensation" panel without an unstained tube, each
single-stained tube must contain unstained control or negative populations.
Gates in "Auto_Compensation" template cannot be deleted.
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6.11.1 Worklist
The worklist area displays samples in table mode, with the default fields including sample ID,
panel, tube name, tube position (autoloading model), NO., and status. The worklist can be set
up to show alternative fields and reorder them as needed.
Operations
Browsing
The samples are listed from top of the table downwards based on the creating time; the latest
sample is at the bottom.
Selecting
Click the desired sample/tube, the line will be highlighted, indicating it is selected. One or more
lines can be selected at a time.
Editing
After acquisition, you may edit sample ID, tube name or other information, the edited contents
will be saved instantly.
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NOTE
Tube name of the Mindray panels cannot be edited.
The analysis time and tube position cannot be edited after acquisition.
Unfold/fold
Click the ― (unfold)‖ button on the upper right of the worklist area, the area will be
Click the ― (fold)‖ button again, the worklist area will restore to its original size.
Worklist Setup
Click the ― (Worklist setup)‖ button on the upper right of the worklist area, the following
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Select the fields; use the "Up", "Down", "Top" and "Bottom" buttons to adjust order, and then
click "OK", the selected fields will be displayed in the worklist area by the order.
Functions of Buttons
Adding sample
Click the " (add sample)" button, a new sample will be added at the bottom of the table.
Click the " (add samples (Batch))" button to add a batch of samples, using one predefined
1. (For autoloading model) enter start sample ID, required number of samples, and select
the panel template and start position in the pop-up dialog box. If the total number of
tubes to be added is more than 40, enable the ―Auto-increase Carousel ID‖ check box
and set up sufficient number of carousels.
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2. (For manual loading model) enter start sample ID, required number of samples, and
select the panel template in the pop-up dialog box.
NOTE
If the “Auto-increase Carousel ID” check box is disabled, a total of 40 tubes
can be added at most in a batch.
If "2-Way LIS/HIS" is selected in the "Setup" - "Communication Setup"
screen, all sample IDs of the batch are fixed to “#” and should be modified in
the worklist.
Adding tube
Click the " (add tube)" button, a new tube will be added under the current sample.
NOTE
16 tubes can be added at most.
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1. Click the " (search)" button in the toolbar (available in the ―Sample Review‖ page
only), the following dialog box will display.
2. Enter the search condition (Name/MR Number/Sample ID/Panel) in the "Search" text
box, and select time range from the "Sample create time" text boxes.
3. Click "OK", the searched results will be displayed in the "Worklist" - "Sample Review"
page.
4. To restore to worklist of all samples, click the " (search)" button again and click
― Samples ‖ button.
Export FCS
1. Select one or more samples/tubes from the worklist table, click the " ( export FCS)"
button in the toolbar, the following dialog box will display.
2. Select directory and enter file name, then click "Save", the selected sample/tube data
will be exported in the format of FCS3.
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Import FCS
1. Select an empty tube from the sample table, click the " ( import FCS)" button in the
toolbar, the following dialog box will display.
2. Select the directory and FCS file, and then click "Open", the FCS data will be imported
to the current tube.
Export as table
All statistic data of samples/tubes can be export as table (csv format), the procedure is as
follows:
1. Select one or more samples/tubes from the worklist table, click the " (Export as
table)" button in the toolbar, the following dialog box will display.
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2. Select directory and enter file name, then click "Save", the selected sample/tube data
will be exported in CSV format.
Saving template
After editing a panel, you may save it as a panel template in the "Panel Template" pull-down
list.
1. Select the sample to be saved as panel template in the worklist, Click " (save as panel
template)" in the toolbar of the "Worklist" screen, the following dialog box will display.
2. To save the template as custom template, enter name of the template and then click
"OK"; the new panel template will be added in the "Custom template" group of the "Panel
Template".
3. If the name of the new template has been used already, the following dialog box will
display. Click "Yes" to overwrite the template with the same name; click "No" to rename
the new template.
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NOTE
The templates in "Empty", “Mindray templates” and “QC templates” groups
are default panel templates, which cannot be overwritten.
Delete
1. Select the sample or tube to be deleted, and click the " (delete)" button in the toolbar,
the following dialog box will display.
Select one or more sample records that have not been checked, and then click " (check)",
the "Status" column of the sample record will be selected.
Select one or more sample records that have been checked, and then click " (cancel
NOTE
After the records are checked, their panels cannot be modified.
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Communication
3. When the " (Comm.)" flag appears by the left of the selected sample(s), the
transmission is finishes.
NOTE
Only samples that have been checked can be transmitted.
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The upper part of the dialog box displays the tube contents that can be synchronized, including
―Acquisition conditions‖, ―Compensation‖ and ―graph Analysis‖. The default setting is ―Select
all‖.
The middle of the dialog box displays available acquisition conditions, including ―Stop
conditions‖, ―Flow rate‖, ―Channel status and volt.‖, ―Display‖, ―Threshold‖ and ―Abs. Count‖.
The default setting is ―Select all‖.
The lower part of the dialog box displays all other tubes of the same sample. All the
un-acquired tubes are selected by default.
Select the tubes and contents to be synchronized, and click ―Apply‖ to enable the tube
synchronization. The system will save the new settings automatically and display the same
settings next time you open the dialog box.
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The upper part of the dialog box displays the tube contents that can be synchronized, including
―Acquisition conditions‖, ―Compensation‖ and ―Analysis graph‖. The default setting is ―Select
all‖.
The lower part of the dialog box displays available acquisition conditions, including ―Stop
conditions‖, ―Flow rate‖, ―Channel status and volt.‖, ―Display‖, ―Threshold‖ and ―Abs. Count‖.
The default setting is ―Select all‖.
Select the content to be copied, and click ―Copy‖ to complete custom copy. The system will
save the new settings automatically and display the same settings next time you open the
dialog box.
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NOTE
If “Paste tube contents” is selected, the “Acquisition conditions” will not be
applied to acquired tubes.
The “Paste tube contents” function is not applicable to samples that use
Mindray templates, have been validated or are being transmitted.
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NOTE
If “Paste sample contents” is selected, the “Acquisition conditions” will not
be applied to acquired tubes.
You cannot paste sample contents to a sample with a different panel.
The “Paste/copy sample contents” function is not applicable to samples
that use Mindray templates or have already been validated.
If the sample to which the contents are to be pasted has less tubes than the
copied one, new tubes will be added automatically to make up for the
difference; if it has more tubes than the copied one, the contents will not be
copied to the extra tubes.
When the ― (unlock)‖ icon displays by the right of the ―Sample Info.‖ and ―Report‖ tabs,
select a sample or switch the sample in the worklist, the first tube of the corresponding sample
will be displayed in the ―Sample‖ screen by default.
When the ― (lock)‖ icon displays by the right of the ―Sample Info.‖ and ―Report‖ tabs, select
a sample or switch the sample in the worklist, the ―Sample Info.‖ or ―Report‖ page of the
corresponding sample will be displayed in the ―Sample‖ screen by default.
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Sample Information
Sample and patient information may be entered in the ―Sample info." screen before or after
acquisition; see 6.6.2 Extended Sample and Patient Information for details.
Tube
The "Tube" screen includes 2 parts, the graph area on the top and the statistics area at the
bottom.
Graph area
You may click the icons in the graphic toolbar to add one or more graphs, the graphs available
are histogram, dot plot, contour plot, density plot and 3D plot.
By clicking the icons in the gating toolbar, you may add one or more gates in the graph; the
available gates are quadrant gate, rectangle gate, ellipse gate, polygon gate, autopolygon gate,
interval gate and bifurcated gate.
Statistics area
The statistics area includes population hierarchy area and other statistics. The "gates" created
in the graph area will be organized and shown in the population hierarchy, and statistics of the
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Report
You may edit and print report, or save the report as PDF in the "Report" screen.
Save as PDF
1. Click the " (save as PDF)" button in the toolbar, the "Save as" window will display.
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3. Click the "Save" button, the report will be saved as a PDF file.
Add/delete page
Click the " (add page)" button to add a page; click the " (delete page)" button to delete
specified page.
Click the " (insert lab info.)" button in the toolbar to insert the predefined lab info. field
Edit text
1. Click the " (insert text)" button, and drag the mouse in the target area, a text box will
be generated in the area for you to enter text.
2. Click the text box and use the text format button to set up font, size, overstriking, italics,
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3. You may move the text box to target position by dragging the mouse.
4. Use the [Delete] key on the keyboard to delete the text box.
Edit lines
1. Click the " (insert line)" button, and drag the mouse in the target area to generate a
line.
2. Click the line and drag its ends to change its length and direction.
3. Use the " (line width)" and " (line color)" buttons to edit line format.
4. You may move the line to target position by dragging the mouse.
Edit graph
1. Go to the "Tube" screen, click the " (send to report)" check box above the target
graph, then the graph will be displayed in the "report‖ screen.
2. Click the graph and drag it to the target position. Drag its borders or tips to zoom the
graph.
3. Click the graph, and then press the [Delete] key in the keyboard to delete it; the "Send
to report" check box of the graph in the "Tube" screen will be deselected automatically.
4. Right click the graph, and select ―Copy Plot‖ from the pop-up menu to copy it to the
clipboard.
1. Double click a graph in the report to activate and enlarge the graph window, as shown
in below figure:
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2. You can edit the axis configuration and channel display range settings on the enlarged
graph window. For details, refer to 2.6.1Graphs.
3. You can modify and edit the gates on the enlarged graph window. For details, refer to
2.6.2 Gates.
Note: if the graphs and gates have been modified, the statistic parameters on the Report
screen will be refreshed accordingly.
Histogram overlay
1. Go to the "Tube" screen; click the " Send to report‖ check box on the upper left of
more than 1 histogram, then the histograms will be displayed in the "Report" screen.
2. Press the [Ctrl] key in the keyboard to select the target histograms one by one.
3. Click the " (overlay)" button in the toolbar, all selected histograms will be displayed
overlaid in the same graph, which is the overlay shown in the following figure.
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NOTE
An overlay allows 5 histograms at most.
The histograms in an overlay must share the same axis parameters, and the
display mode shall not be biexponential.
Edit statistics
1. Go to the "Tube" screen, click the " (send to report)" check box on the upper left of
the statistics table, then the table will be displayed in the "report ―screen.
2. Click and hold the boundary line between two columns, then drag the line to adjust the
width of the columns.
3. Click the table and drag it to target position. Drag its borders or tips to zoom it, font size
in the table will not change.
1. Click the " (insert parameter results)" button, the following dialog box will display.
The parameters displayed are determined by the panel.
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2. To add one or more parameters in the table into the report, click the "Send the report"
check box of the corresponding line; to remove a parameter added, click the "Send to
report" check box to deselect it.
3. Click the "Delete" button to delete the selected parameters in the table.
4. Click the "New" button, the "New" dialog box will display, select tube from the "Tube"
pull-down list, and then the population hierarchy of the tube will be displayed.
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5. Select a tube and basic statistics to be added from the population hierarchy, or define
statistics by combination of options from "Statistic", ‖Population‖ and ―Axis‖ pull-down
lists. Use the calculator by the right to perform calculation of available statistics to
generate new statistics, enter the full name, unit, length, abbreviation and reference
range of the new statistic (see the following figure).
6. Click "OK", the new parameter will be added into the table of "Custom Parameters".
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5. Click the "Edit" button below to open the "Edit" window to edit the defined parameters.
6. Click "OK", the defined parameter table will be sent to the "Report" screen.
Composing tools
The composing tools provided in the "Report" screen include the alignment buttons and unfold
buttons.
Alignment buttons include the align left, align right, align top, align bottom, vertical center align,
and horizontal center align buttons, as shown in the following figure.
Unfold buttons include the vertical and horizontal unfold buttons, as shown in the following
figure.
Press the [Ctrl] key in the keyboard and select the elements(text boxes, graphs, lines, tables,
etc) to be composed, and then click the make-up buttons to compose them.
All the modifications to the elements (Sample info., Report, graphs, gates, statistics, etc) can
be saved and restored, by means of creating Restore point and restoring to it.
Click the " (Creating Restore point)" button on the upper right of the ‖Sample‖ - ―Tube‖
screen, and the current ―Sample‖ elements will be saved.
NOTE
Restore points will be created automatically for samples of “Mindray
templates” and “QC templates” after acquisition.
Click the " (Creating Restore point)" button on the upper right of the ‖Sample‖ - ―Tube‖
screen, and the following dialog box will pop up.
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Click ―OK‖ to restore to the ―Sample‖ screen when the restore point was created.
If there are any flags with the samples of Mindray panels, a note will be displayed on the top
middle of the ―Sample‖ screen saying: ―Check the gating, see ""Sample Info."" for details."
Review the detail information in ―Analysis info.‖ on the ―Sample info.‖ screen.
The ―Analysis info.‖ of Mindray panels shows both flags and notes, as shown in below figure.
Mindray Panels Analysis information
Lymphocyte Subsets Flags Lymphocyte count in tube T does not meet stop
(T/B/NK-Auto) requirement
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WARNING
Be sure to back up important data regularly in case of data loss by accident.
It is recommended that you perform data backup weekly and important data as needed.
Export (backup)
Do as follows to export a file:
1. Select one or more samples in the worklist, click the " (export)" button in the toolbar,
the following dialog box will display.
2. Select directory and enter file name, then click "Save", the selected sample data will be
exported in the default format (export file).
NOTE
The exported file takes sample as the unit, an information unit includes
control panel options, sample information, panel template, report, etc.
Restoring
Do as follows to restore samples:
1. Click the " (restore)" button in the toolbar, the following dialog box will display.
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2. Select directory and file, and then click "Open", the samples in the selected file will be
added to the table of current samples; the restored samples may be edited or
reanalyzed.
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6.12 Standby
When the time set for entering standby mode is reached, the cytometer will perform standby
preparation, and the indicator light flickers in green. When the preparation is done, the
cytometer is in standby mode, and the indicator light is in static yellow.
Refer to 5.2.1 Host Setup for how to edit waiting time before entering standby mode.
NOTE
Data analysis on software is supported in standby preparation and standby
modes, but acquisition is not allowed.
To exit the standby mode, click the " (Acquire)" button in the control toolbar, the following
dialog box will display.
Click "Yes", a progress bar will display, and the cytometer performs exiting standby procedure.
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6.13 Shutdown
All the samples, controls, wastes and areas contacted by 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.
WARNING
The sample probe may contain biohazardous materials. Exercise caution to
avoid contact with the probe when working around it.
CAUTION
Do not start up the cytometer immediately after it is shut down. Wait for at
least 10 seconds.
NOTE
Be sure to shut down the cytometer strictly as instructed below.
1. Click the " (shutdown)" button in the quick icon area of the software screen, the
following dialog box will display.
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3. Place the tube with at least 3mL of diluted CLEANING SOLUTION (please dilute the
CLEANING SOLUTION with distilled water first, dilution ratio 1:10) into the manual
loading tube holder, and click "OK" to perform shutdown procedure; the dialog box will
close automatically.
NOTE
Be sure to dilute the CLEANING SOLUTION with distilled water before
performing shutdown procedure, dilution ratio 1:10.
4. After CLEANING SOLUTION maintenance finishes, the following dialog box will display.
5. Place the tube with at least 3mL of distilled water into the tube holder, and "OK" to
perform shutdown procedure, the tube holder will rise automatically.
6. When the shutdown procedure finishes, the following dialog box will display. The
cytometer indicator light turns into static yellow, and the status indicator on the software
screen turns black, you may then power off the cytometer safely.
1. Click the " (shutdown)" button in the quick icon area of the software screen, the
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3. Place a tube with at least 3mL of diluted CLEANING SOLUTION (please dilute the
CLEANING SOLUTION with distilled water first, dilution ratio 1:10) and another tube with
at least 3mL of distilled water into position 1 and 2 of the autoloader respectively, and
then click "OK" to perform shutdown procedure, the dialog box will close automatically.
NOTE
Be sure to dilute the CLEANING SOLUTION with distilled water before
performing shutdown procedure, dilution ratio 1:10.
4. When the shutdown procedure finishes, the following dialog box will display. The
cytometer indicator light turns into static yellow, and the status indicator on the software
screen turns black, you may then power off the cytometer safely.
Click the " " button on the upper right of the software screen to close the MRFlow window.
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1. Close the external computer according to the shutdown procedures of the operation
system.
NOTE
You should first exit the MRFlow software, and then shut down the external
computer according to the shutdown procedures of the operation system.
Otherwise, the records in the sample database of the MRFlow software may be
lost.
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7 Using the QC Programs
7.1 Introduction
BriCyte E6 Flow Cytometer provides auto setup and parameter QC programs.
Auto setup is used for BriCyte E6 Flow Cytometer automatic setup and daily tracking. The
applicable material is the fluorescence setup particles.
Every fluorescence setup particle contains a mixture of fluorophores, with a fluorescence
emission over all 6 fluorescence channels when excited by the blue and red lasers.. While
running auto setup, detector voltages are adjusted to place particles at defined target values,
and spectral overlap values are calculated and applied to compensate data for fluorescence
spillover. At the same time, delay time is calibrated to match the red laser signals with blue
laser signals of the same particle. The MRFlow software automatically records the settings
each time you run the fluorescence setup particles, and generates the Levey-Jennings curve,
which facilitates your long-term status tracking of the cytometer.
The parameter QC is used to monitor the multi-step process of the lymphocyte subset test
(T/B/NK, CD3/8/45/4), including antibody staining, erythrocyte lysis, cytometer performance
and settings, and data analysis. The operator can use blood controls which have assay values
for the parameter QC.
Stain and lyse the blood control in the same way of processing the blood sample, and then run
it on the Flow Cytometer. Compare the results with the reference values using statistics
method. Measures should be taken if there are obvious deviations between the results and the
reference values.
NOTE
Use the control and reagents specified by the manufacturer only. Store and
use the control and reagents as instructed by instructions for use of the
reagents. It is recommended that run QC every day before acquisition.
If Mindray templates are to be used in the day, auto setup will be necessary
before running samples, see 7.2 Auto Setup.
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Using the QC Programs
7.2.1 Information
Before running auto setup, you need to set up the information of the particles for the current
batch at the screen below:
7-2
Using the QC Programs
You can set up the information using any of the following ways:
1. Find the 2D barcode provided by the manufacture from the package of the particles (code
system: QR Code), shown in the figure below.
2. Click the "2D Code Scan" button on bottom of the "Info." screen, and the dialog box below
pops up.
3. Scan the 2D barcodes one by one using the barcode scanner. The barcodes successfully
identified are displayed in green, while those cannot be identified are displayed in red, as
shown in the figure below. To exit before finishing the scanning, press [ESC] on the
keyboard.
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Using the QC Programs
NOTE
It is forbidden to use the keyboard or switch to another window while
scanning the 2D barcode of the particles.
4. After the 3 2D barcodes are all scanned, the software automatically identifies the particles
information. When the analysis finishes, the information will be displayed on the screen.
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Using the QC Programs
1. Click the "Import" button on bottom of the "Info." screen, and the dialog box below pops
up.
2. Browse to the information file, and then click "Open". The information will be imported to
the current screen.
Manual entry
1. Enter the basic information of the particles in the "Basic info." area, including "BATCH
CODE", "Product ID", "FS threshold", and "Flow rate".
NOTE
The BATCH CODE shall not be empty and up to 10 digits can be
entered. You can enter characters, numbers, letters and special
characters.
2. In the "Channel targets" area, set up the targets of autoloading algorithm parameters in
different channels.
3. In the "Compensation matrix" area, set up the compensation values between
fluorescence channels for MR Panels.
4. The entry will be saved once it is completed.
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Using the QC Programs
1. Click the "BATCH CODE" pull-down list in the "Basic info." area, and select a preset
batch code, as shown in the figure below.
2. The information corresponding to this batch code will be displayed on the current screen.
All the samples, controls, wastes and areas contacted by 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.
WARNING
The sample probe may contain biohazardous materials. Exercise caution to
avoid contact with the probe when working around it.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
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.
Stop using the cytometer when you find any fluid tubing or part filled with
fluid is aging or wearing, and contact the service engineer or your local
distributor to replace.
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Using the QC Programs
CAUTION
Running auto setup and QC analysis when there is an error may lead to
incorrect analysis results. If an error is reported in the process, remove the
error first before continuing with the auto setup or QC analysis.
NOTE
Use the particles specified by the manufacturer only. Using particles other
than specified may lead to incorrect results. Do not use particles other than
specified.
Store and use the particles as instructed by instructions for use of the
particles.
To get reliable results, make sure you prepare the particles on the day of
analysis and store it in the dark.
After the particles information is entered, you can start auto setup.
7-7
Using the QC Programs
1. Prepare the particle solution: add 1~2 drops of the fluorescence setup particles into a
tube with 1mL sheath. Mix the solution well and place it in the tube holder (manual
loading) or assigned tube position (autoloading).
2. In the "Control Panel" area (for autoloading model only), verify the tube position for
autoloading.
3. Click "Start" to start the analysis.
4. The cytometer automatically completes the delay time calibration and voltage calibration,
as shown in the figure below.
5. After the auto setup is finished, the report will be displayed at the "QC detail" screen, as
shown in the figure below.
7-8
Using the QC Programs
NOTE
If the auto setup fails, make sure there is no operation mistake and retry.
When the auto setup keeps failing, contact our service department to
calibrate the cytometer if necessary.
1—The auto setup report of points along the green vertical line
2—The tested values of points along the green vertical line
3—The line connecting all points of the same parameter to show the trend. The points in each
graph are displayed from left to right according to the sequence from the earliest to the latest.
A black point indicates the value is within the limit; a red point indicates the value is out of the
limit.
4—The green vertical line is used to identify the points of the same analysis, all of which are
displayed on the line when you select one of them.
5—New batch of particles which is marked in different color in the graph.
7-9
Using the QC Programs
NOTE
The green line and the corresponding values of the QC points will not be
printed.
7-10
Using the QC Programs
7.3 Parameter QC
You can set up the control information using any of the following ways:
Manual entry
Manual entry
1. Enter the basic information of the control in the "Basic info." area, including "BATCH
CODE", "Product ID", and "Exp. date".
NOTE
The BATCH CODE shall not be empty and up to 10 digits can be
7-11
Using the QC Programs
2. In the "Target" area, set up the parameter targets and the allowable limits.
3. The entry will be saved once it is completed.
1. Click the "BATCH CODE" pull-down list in the "Basic info." area, and the list shows the
control batch code saved most recently, as shown in the figure below.
2. The control information corresponding to this batch code will be displayed on the current
screen.
7-12
Using the QC Programs
7.3.2 QC Analysis
All the samples, controls, wastes and areas contacted by 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.
WARNING
The sample probe may contain biohazardous materials. Exercise caution to
avoid contact with the probe when working around it.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
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.
Stop using the cytometer when you find any fluid tubing or part filled with
fluid is aging or wearing, and contact the service engineer or your local
distributor to replace.
CAUTION
Running auto setup and QC analysis when there is an error may lead to
incorrect analysis results. If an error is reported in the process, remove the
error first before continuing with the auto setup or QC analysis.
7-13
Using the QC Programs
NOTE
Store and use the control as instructed by instructions for use of the
control.
Once information of a new batch parameter QC is entered, all the following
parameter QC results will be included in the reports of the new batch
automatically, even if the old batch is selected in the QC information screen.
After the control information is entered, you can start the QC analysis.
1. Prepare and mix the control according to the instructions for use of the blood control.
2. Stain and lyse the blood control according to the instructions of the reagents for
lymphocyte subset analysis.
5. Select the corresponding QC template from the "Panel" pull-down list, e.g. “QC- T/B/NK”
6. Select manual loading or autoloading according to the configuration of the cytometer, and
then test the prepared control sample. Refer to 6.8 Running Samples - Manual Loading or
6.9 Running Samples - Auto Loading.
7. If needed, adjust compensation values and gates to obtain correct positive and negative
populations.
8. When the QC analysis is finished, the results will be included in the reports of the latest
batch.
NOTE
If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
the error information area; see 9 Troubleshooting.
7.3.3 QC Review
After QC analysis, you can review the QC results in the following ways:
QC graph review
QC table review
7-14
Using the QC Programs
QC Graph Review
Click "QC" "Parameter QC Review" to go to the "Parameter QC Review" screen.
From the "QC point" pull-down list, you can select to review "Monthly QC" or "All QC". The
figure below shows the monthly QC graph.
7-15
Using the QC Programs
NOTE
The green line and the corresponding values of the QC points will not be
printed.
QC Table Review
Click "Work Center" to switch to the "Work Center" screen.
Click the " (Search)" button in the tool bar. Then use the QC panel (QC-T/B/NK、
QC-CD3/8/45/4) as the searching filter, and specify the time. The "Search Results" screen will
show the history QC table.
You can use the buttons on the tool bar of the "WorkList" screen to export (FCS, table), archive,
delete, check or communicate. Refer to 6.11.1 Worklist for details.
7-16
8 Servicing Your Cytometer
8.1 Introduction
Preventive and corrective maintenance procedures are required to keep the cytometer in a
good operating condition. This cytometer provides multiple maintenance functions for this
purpose.
This chapter introduces how to use the provided functions to maintain and troubleshoot your
cytometer.
CAUTION
Improper service may damage the cytometer. Make sure you service the
cytometer strictly as instructed by this manual.
For problems not mentioned in this manual, contact Mindray customer
service department for service advice provided by professionals assigned
by Mindray.
Only parts supplied by Mindray can be used for maintenance. For any
questions, contact Mindray Customer Service or your local distributor.
Exercise caution to avoid contact with the sharp sample probe when
performing maintenance.
8-1
Servicing Your Cytometer
All the samples, controls, wastes and areas contacted by 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.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.
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.
Stop using the cytometer when you find any fluid tubing or part filled with
fluid is aging or wearing, and contact the service engineer or your local
distributor to replace.
When the cytometer is waiting for service, it is suggested that sterilize and
clean the potentially bio-hazardous parts (cytometer surface, sample probe,
etc.), in order to reduce the risk of bio-hazard or other hazard while
transporting or servicing the cytometer.
CAUTION
To ensure the accuracy of test results, do not mix the new container of
sheath fluid with the old one.
8-2
Servicing Your Cytometer
NOTE
Avoid strong turbulence to the sheath container and collision with other
objects. Otherwise, the error report may be unreliable.
If there is an error message of sheath fluid insufficient, running out, or expired, replace with a
new container of sheath fluid. Do as follows:
Replace with a new container of sheath fluid (see 8.6.2 How to Replace for details)
Perform sheath filter priming as instructed by 8.3.6 Priming
8-3
Servicing Your Cytometer
8.3 Maintenance
Click "Service" - "Maintenance" to go to the "Maintenance" screen.
Unclog Flow Flow cell clog is reported To remove the flow As needed
Cell cell clog error
Unclog Sample probe clog is reported To decontaminate As needed
Sampling the sample probe
Channel
8-4
Servicing Your Cytometer
Prime Sheath After installing a new container of To make the filter As needed
Filter sheath fluid because of sheath fluid fully filled with
Prime Bubble After replacing the bubble filter To make the filter As needed
Filter fully filled with
sheath fluid
8.3.3 De-gas
The operator can perform the following de-gassing operations:
De-gas Fluidics
2. After the de-gassing is finished, the progress bar disappears. Repeat the steps if needed.
8-5
Servicing Your Cytometer
2. After the de-gassing is finished, the progress bar disappears. Repeat the steps if needed.
8.3.4 Cleaning
The operator can perform the following cleaning operations:
Fluidics Initialization
2. Put the tube with 1ml of CLEANING SOLUTION to the tube holder, and then click "OK".
The holder goes upwards, and the cleaning starts, while the screen displaying the
progress bar below.
3. After the cleaning is finished, the progress bar disappears. Repeat the steps if needed.
Fluidics Initialization
Initialize the fluidics as instructed below:
1. Click the "Fluidics Initialization" button to start, and the progress bar below pops up.
2. After the initialization is finished, the progress bar disappears. Repeat the steps if
needed.
8-6
Servicing Your Cytometer
8.3.5 Unclogging
The operator can perform the following unclogging operations:
2. After the unclogging is finished, the progress bar disappears. Repeat the steps if needed.
2. After the unclogging is finished, the progress bar disappears. Repeat the steps if needed.
8.3.6 Priming
The operator can perform the following priming operations:
8-7
Servicing Your Cytometer
2. After the priming is finished, the progress bar disappears. Repeat the steps if needed.
2. After the priming is finished, the progress bar disappears. Repeat the steps if needed.
8-8
Servicing Your Cytometer
8.4 Status
At the "Status" screen, the operator can check the information displayed, but cannot edit. The
information at the "Status" screen can help operators to discover and remove errors. Status
parameters of the following items are displayed:
Fluidics
Red laser
Blue laser
Other temperatures
Circuit system
8-9
Servicing Your Cytometer
8.4.1 Fluidics
You can check the following fluidics status parameters:
Sample flow
Sheath volume
8-10
Servicing Your Cytometer
Waste volume
Temperature
Current
Power
Temperature
Current
Power
8-11
Servicing Your Cytometer
8-12
Servicing Your Cytometer
8.5 Self-Test
Click "Service" - "Self-Test" to go to the "Self-Test" screen, where the following items are
displayed:
Self-test of indicators
Valve Self-Test
2. The status bar on bottom left of the screen shows " Please check if the buzzer can
work/stop as normal, and the indicator can switch to static red, yellow, and green in turn ".
3. Check if the buzzer is beeping, indicator can switch to static red, yellow, and green in
turn.
4. After the self-test is finished, the progress bar disappears, and the indicator on bottom left
of the software screen turns back into static green, which shows the self-test is
successful.
8-13
Servicing Your Cytometer
Run the self-test of probe wipe, loading system, sheath pump, waste pump, rotating motor
(for autoloading model) as instructed below:
1. Click the button of the item you want to test, the test starts, and the progress bar below
pops up.
2. After the self-test is finished, the progress bar disappears, and the indicator on bottom left
of the software screen turns back into static green, which shows the self-test is
successful.
NOTE
If the self-test result is abnormal, the indicator of the software flickers red,
and a dialog box pops up to tell “Self-test failed”. Try again after clicking
“OK". If the result is still abnormal after you tried several times, please
contact Mindray Service Department or your local distributor.
8-14
Servicing Your Cytometer
pops up.
2. The status bar on bottom left of the screen shows "Please check if the waste pump can
open and close as normal".
3. Determine whether the waste pump is open according to the sound.
4. After the self-test is finished, the progress bar disappears, and the indicator on bottom left
of the software screen turns back into static green, which shows the self-test is
successful.
Run the self-test of the autoloading electromagnetic lock (autoloading model) as instructed
below:
1. Click the button of the item you want to test, the dialog box and progress bar below pop
up.
2. Click the "OK" button, the test starts, and the dialog box and progress bar below pop up.
3. Try to open the autoloader door. If it cannot be opened, click the "OK" button.
4. At this time, the dialog box and the progress bar below pop up.
5. Try to open the autoloader door. If it can be opened, click the "OK" button.
6. After the self-test is finished, the indicator on bottom left of the software screen turns back
into static green, which shows the self-test is successful.
8-15
Servicing Your Cytometer
In the valve self-test, the operator should confirm whether the valves make the "click" sound
properly, in order to know whether they work normally.
Click the desired valve NO. (e.g. "1"), and check if the valve make the "click" sound twice.
NOTE
If the self-test result is abnormal, the indicator of the software flickers red,
and a dialog box pops up to tell “Self-test failed”. Try again after clicking
“OK”. If the result is still abnormal after you tried several times, please
contact Mindray Service Department or your local distributor.
8-16
Servicing Your Cytometer
Run the self-test of flow sensor, flow cell pressure sensor, waste cistern pressure sensor as
instructed below:
1. Click the button of the item you want to test, the test starts, and the progress bar below
pops up.
2. After the self-test is finished, the progress bar disappears, and the indicator on bottom left
of the software screen turns back into static green, which shows the self-test is
successful. The self-test result is displayed in the field after the corresponding item.
8-17
Servicing Your Cytometer
2. Put the tube filled with no less than 1ml distilled water into the tube holder (manual
loading) or Position 20 of the carousel (autoloading), and then click "OK".
3. After the self-test is finished, the progress bar disappears, and the indicator on bottom left
of the software screen turns back into static green, which shows the self-test is
successful. The self-test result is displayed in the field after the corresponding item.
2. Seal the opening of the sample probe tip using an applicable tube, and then click "OK".
3. After the self-test is finished, the progress bar disappears, and the dialog box below pop
up.
4. Remove the tube which sealed the sample probe outlet, and then click ‖OK‖.
5. The indicator on bottom left of the software screen turns back into static green, which
8-18
Servicing Your Cytometer
shows the self-test is successful. The self-test result is displayed in the field after the
corresponding item.
NOTE
If the self-test result is abnormal, the indicator of the software flickers red,
and a dialog box pops up to tell “Self-test failed”. Try again after clicking
“OK”. If the result is still abnormal after you tried several times, please
contact Mindray Service Department or your local distributor.
8-19
Servicing Your Cytometer
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.
8-20
Servicing Your Cytometer
CAUTION
After sheath container or waste container replacement, check and make
sure all tubes connected with the cap assemblies are not bent or
disconnected.
3. Tweak the cap of the old sheath container counterclockwise, and remove the cap
assembly cautiously.
4. Insert the pickup tubes of the cap assembly into the new sheath container, and then
tweak the cap clockwise to secure it.
5. Cap the old container with the cap of the new one, and dispose of it properly.
3. Tweak the cap of the old waste container counterclockwise, and remove the cap
assembly cautiously.
4. Insert the cap assembly into the new waste container, and then tweak the cap clockwise
to secure it.
5. Cap the old container with the cap of the new one, and dispose of it properly.
8-21
Servicing Your Cytometer
2. Remove the 3 capture screws fixing the right door. Grab the bottom of the right door and
pull it out horizontally.
3. Put some tissue paper under the tubing of the filter to avoid contamination of the cytometer
by the leakage.
4. Remove the 2 capture screws fixing the filter presser, and then take off the pressure
5. Disconnect the connectors above, below and by the side of the filter (Press the metal leaf
spring; take off connectors of the tubing. The connectors above and below the filter are of
the same model.), and then take off the filter.
6. Install the new filter and the presser back. Make sure the convex of the filter under its side
connector fits right into the concave of the presser.
8-22
Servicing Your Cytometer
7. Reconnect the tubing above, below and by the side of the filter, and then take away the
tissue paper.
8. Perform ―Prime Sheath Filter‖ or ―Prime Bubble Filter‖ on the ―Service‖ – ―Maintenance‖
screen based on the filter type you replaced. Make sure the tubing is well connected, and
no leakage is found.
9. After finishing the priming procedure, install the right door of the cytometer back.
8-23
Servicing Your Cytometer
8.7 Log
The log records the key operations performed on the cytometer. It provides the operators an
access to review the operating history, and service personnel the facilitation of
troubleshooting.
The software can save logs of the past 2 years. If number of logs exceeds the upper limit, the
latest log will overwrite the oldest one. You can browse and export logs, but cannot delete
them.
Click "Log" to go to the screen shown below.
Click the following tab to display different type of logs: "All logs", "Other logs", "Parameter
modification", "Error info.", or "Sequence running".
Enter or select the starting and ending dates in the fields above the log list to define a desired
date range of logs.
Select the desired source of logs from the pull-down list, e.g. MRFlow.
8-24
Servicing Your Cytometer
2. After specifying the directory to save the exported logs, click the "Save" button, and the
selected logs will be exported to a CSV file.
8-25
Servicing Your Cytometer
8-26
9 Troubleshooting
9.1 Introduction
This chapter contains information that is helpful in locating and correcting problems that may
occur during operation of your cytometer.
NOTE
This chapter is not a complete service manual and is limited to problems
that are readily diagnosed and/or corrected by the user of the cytometer.
9-1
Troubleshooting
Removing error
Click the "Remove" button, and the software starts to remove the errors. For errors that cannot
be removed by the software, operators can try removing it as instructed by the "Help"
information.
9-2
Troubleshooting
9-3
Troubleshooting
9-4
Troubleshooting
Sheath aspiration is 2. If the error still exists, contact our Customer Service
abnormal Department.
1020101 1. Click "Remove" and then try again;
Waste discharge is 2. If the error still exists, contact our Customer Service
abnormal Department.
1. Click "Remove" and then try again;
1030101
2. If the error still exists, contact our Customer Service
Loading action is abnormal
Department.
1. Click "Remove" and then try again;
1030201
2. If the error still exists, contact our Customer Service
Loading action is abnormal
Department.
1040101 1. Click "Remove" and then try again;
Probe wipe action is 2. If the error still exists, contact our Customer Service
abnormal Department.
1040201 1. Click "Remove" and then try again;
Probe wipe action is 2. If the error still exists, contact our Customer Service
abnormal Department.
1050101 1. Click "Remove" and then try again;
Carousel action is 2. If the error still exists, contact our Customer Service
abnormal Department.
2010101 1. Click "Remove" and then try again;
Sheath aspiration is 2. If the error still exists, contact our Customer Service
abnormal Department.
2020101 1. Click "Remove" and then try again;
Waste discharge is 2. If the error still exists, contact our Customer Service
abnormal Department.
1. Click "Remove" and then try again;
2030101
2. If the error still exists, contact our Customer Service
Loading action is abnormal
Department.
2040101 1. Click "Remove" and then try again;
Probe wipe action is 2. If the error still exists, contact our Customer Service
abnormal Department.
2050101 1. Close the autoloader door, click "Remove" and then try again;
Carousel action is 2. If the error still exists, contact our Customer Service
abnormal Department.
2060101 1. Close the autoloader door, click "Remove" and then try again;
Carousel action is 2. If the error still exists, contact our Customer Service
abnormal Department.
2070101 1. Close the autoloader door, click "Remove" and then try again;
Autoloader door is not 2. If the error still exists, contact our Customer Service
closed Department.
1. Put in the carousel, close the autoloader door, click "Remove"
2080101
and then try again;
Carousel not detected
2. If the error still exists, contact our Customer Service
9-5
Troubleshooting
Department.
2080102 1. Close the autoloader door, click "Remove" and then try again;
Carousel action is 2. If the error still exists, contact our Customer Service
abnormal Department.
1. Put a tube into the assigned tube position, click "Remove"
2090101 and then try again;
Tube not detected 2. If the error still exists, contact our Customer Service
Department.
1. Close the optical box, click "Remove" and then try again;
2100101
2. If the error still exists, contact our Customer Service
Optical box is open
Department.
1. Perform "Maintenance-Prime Sheath Filter", click "Remove"
2110101
and then try again;
Waste discharge is
2. If the error still exists, contact our Customer Service
abnormal
Department.
1. Make sure the working temperature of the cytometer is within
2120101
the range 15~32℃, click "Remove" and then try again;
Red laser temperature is
2. If the error still exists, contact our Customer Service
abnormal
Department.
1. Make sure the working temperature of the cytometer is within
2130101
the range 15~32℃, click "Remove" and then try again;
Blue laser temperature is
2. If the error still exists, contact our Customer Service
abnormal
Department.
1. Click "Remove" and then try again;
2160101
2. If the error still exists, contact our Customer Service
Loading action is abnormal
Department.
2170101 1. Click "Remove" and then try again;
Probe wipe action is 2. If the error still exists, contact our Customer Service
abnormal Department.
1. Check if the sample volume is not enough or if there are too
many bubbles, analysis the sample again after solving the
problems;
3010101
2. Perform "Maintenance-Clean Flow Cell" for 1~3 times, click
Flow sensor is abnormal
"Remove" and then try again;
3. If the error still exists, contact our Customer Service
Department.
1. Check if there are particulate matters or too many bubbles in
the sample, run the sample again after solving the problems.
3010301 2. Perform "Maintenance-Unclog Sampling Channel" for 1~3
Sample probe clogged times, click "Remove" and then try again;
3. If the error still exists, contact our Customer Service
Department.
3010401 1. Check if there are particulate matters or too many bubbles in
Flow cell clogged the sample, run the sample again after solving the problems.
9-6
Troubleshooting
9-7
Troubleshooting
Department.
3080101 1. Click "Remove" and then try again;
Blue laser temperature 2. If the error still exists, contact our Customer Service
sensor is abnormal Department.
1. Make sure the working temperature of the cytometer is within
3080401
the range 15~32℃, click "Remove" and then try again;
Blue laser temperature is
2. If the error still exists, contact our Customer Service
too high
Department.
1. Make sure the working temperature of the cytometer is within
3080501
the range 15~32℃, click "Remove" and then try again;
Blue laser temperature is
2. If the error still exists, contact our Customer Service
too low
Department.
1. Make sure the working temperature of the cytometer is within
3090101
the range 15~32℃, click "Remove" and then try again;
Ambient temperature
2. If the error still exists, contact our Customer Service
sensor is abnormal
Department.
3100101 1. Click "Remove" and then try again;
Optical temperature sensor 2. If the error still exists, contact our Customer Service
is abnormal Department.
1. Close the optical box, click "Remove" and then try again;
3130401
2. If the error still exists, contact our Customer Service
Blue laser power is too high
Department.
1. Close the optical box, click "Remove" and then try again;
3130501
2. If the error still exists, contact our Customer Service
Blue laser power is too low
Department.
1. Close the optical box, click "Remove" and then try again;
3140401
2. If the error still exists, contact our Customer Service
Red laser power is too high
Department.
1. Close the optical box, click "Remove" and then try again;
3140501
2. If the error still exists, contact our Customer Service
Red laser power is too low
Department.
4010401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
4020401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
5010401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
5020401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
6010401 1. Restart the cytometer;
9-8
Troubleshooting
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
6020401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
6030401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
7010401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
7020401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
7030401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
7040401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
7050401 1. Restart the cytometer;
Drive board voltage is 2. If the error still exists, contact our Customer Service
abnormal Department.
1. Shutdown procedure not finished as normal, remove other
8010101
errors first and click "Remove";
Startup procedure not
2. If the error still exists, contact our Customer Service
completed
Department.
1. Shutdown procedure not finished as normal, remove other
8010201
errors first and click "Remove";
Startup procedure not
2. If the error still exists, contact our Customer Service
completed
Department.
1. Startup after Pack-up procedure is skipped, click "Remove"
8010301
and then try again;
Startup procedure not
2. If the error still exists, contact our Customer Service
completed
Department.
8010401 1. Restart the cytometer;
Startup procedure not 2. If the error still exists, contact our Customer Service
completed Department.
1. Shutdown procedure not finished as normal, remove other
8020101 errors first and click "Remove", then start the shutdown
Shutdown procedure not procedure again.
finished 2. If the error still exists, contact our Customer Service
Department.
8020201 1. Restart the cytometer;
9-9
Troubleshooting
Shutdown procedure not 2. If the error still exists, contact our Customer Service
finished Department.
8020301
Pack-up shutdown process was interrupted by errors, please
Pack-up and Shutdown
perform pack-up shutdown procedure again.
procedure is interrupted
1. Exiting from standby mode not finished as normal, remove
8030101
other errors first and then click "Remove";
Exiting from standby mode
2. If the error still exists, contact our Customer Service
not finished
Department.
8040101 1. Click "Remove";
The error status lasts for 2. If the error still exists, contact our Customer Service
too long Department.
1. Acquisition was interrupted, remove other errors first, click
8050101
"Remove" and then try again;
Workflow is interrupted by
2. If the error still exists, contact our Customer Service
error
Department.
1. Check if the worklist and the carousel No. are consistent, and
9010101 then click "Remove";;
Carousel ID not match 2. If the error still exists, contact our Customer Service
Department.
1. Make sure a tube with sufficient sample has been loaded,
9010301
click "Remove" and then try again;
Sample aspiration is
2. If the error still exists, contact our Customer Service
abnormal
Department.
9010401 1. Take out any tube, click "Remove" and then try again;
No idle tube position in the 2. If the error still exists, contact our Customer Service
carousel Department.
1. Check if there are other errors, if yes, remove the other errors
first, and then perform filter self-test again;
9010501 2. Perform "De-gas Fluidics " to remove the error, and perform
Filter self-testing failed self-test again;
3. If the error still exists, contact our Customer Service
Department.
1. Check if there are other errors, if yes, remove the other errors
9010601 first, and then perform self-test again;
Red laser self-testing failed 2. If the error still exists, contact our Customer Service
Department.
1. Check if there are other errors, if yes, remove the other errors
9010701 first, and then perform self-test again;
Blue laser self-testing failed 2. If the error still exists, contact our Customer Service
Department.
9010801 1. Check if there are other errors, if yes, remove the other errors
Tubing tightness first, and then perform self-test again;
self-testing failed 2. If the error still exists, contact our Customer Service
9-10
Troubleshooting
Department.
1. Check if there are other errors, if yes, remove the other errors
9010901
first, and then perform warm-up system self-test again;
Warm-up system
2. If the error still exists, contact our Customer Service
self-testing failed
Department.
9-11
Troubleshooting
9-12
Troubleshooting
Department.
Backflow into the tube Flow sensor is abnormal 1. Restart the cytometer, and then
run the "Clean Flow Cell"
procedure
2. If the error still exists, contact
our Customer Service
Department.
Unable to aspirate sheath Tubing bent, Replace tubing
fluid or discharge waste disconnected, or cracks
Valve error Contact our Customer Service
Department
Tube not detected No tube or tube Place the tube in position properly
improperly placed
Tube contaminated or Replace the tube
cracks
Sensor error Contact our Customer Service
Department
Jam between tube and Tube specification Use applicable tubes
carousel while the tube inapplicable
ascending or descending Autoloader error 1. Restart the cytometer
2. If the error still exists, contact
our Customer Service
Department.
Unable to open the Not switched to Switch to batch loading model
autoloader door batchloading model
Autoloader error 1. Restart the cytometer
2. If the error still exists, contact
our Customer Service
Department.
Auto QC delay time or Bead concentration Prepare the bead solution again
voltage calibration failed too low or expired
Optical system is Contact our Customer Service
abnormal Department
Sample processing speed is Improper flow rate Use middle or low flow rate
too high Low threshold Increase the threshold
Sample concentration Dilute the sample or centrifuge to
high or excessive debris remove debris
Excessive background noise Flow cell contaminated Run the "Clean Flow Cell"
dots procedure
Sheath fluid Replace with a new container of
contaminated or expired sheath fluid, and run "Prime
Sheath Filter" and "Prime Bubble
Filter"
Bubbles in flow cell Run "De-gas Flow Cell"
9-13
Troubleshooting
9-14
10 Appendices
A Index
A I
About, 2-38 Installation, 4-2
Analysis Tools
Gates, 2-30
M
Graphs, 2-23
Statistics, 2-34, 2-38 Mindray Panels, 2-2
Applicable Tubes
12×75 mm Tube, 6-8, B-1
O
Centrifugal tube, 6-8, B-1
Auto Setup, 7-2
Optical
Optical Detection, 3-4
C Optical Excitation, 3-4
Configuration, B-1
P
Lasers, B-2
Optical Filters, B-2
Performance
control and signal processing
Carryover, B-4
Drive and monitor unit, 3-8
Fluorescence linearity, B-3
Main control unit, 3-7
Fluorescence sensitivity, B-3
power unit, 3-8
Forward scatter sensitivity, B-3
Preamplification unit, 3-7
Instrument Stability, B-4
Controls and Calibrators, 2-40
Maximum Acquisition Rate, B-4
Cytometer
Precision, B-3
Flow Cytometer, 1-1, 2-1
Resolution of Forward and side scatter, B-4
Side scatter sensitivity, B-3
E
Q
EMC, B-6
Quality Control
F Parameter QC, 7-11
Fluidic
R
Change of Flow Rate, 3-2
Formation of Sample Flow, 3-2
Reagent
CLEANING SOLUTION, 2-39
SHEATH FLUID, 2-39
A-1
Appendices
A-2
B Specifications and Performance
B.1 Classification
According to the CE classification, the BriCyte E6 Flow Cytometer belongs to In vitro
diagnostic medical devices other than those covered by Annex II and devices for performance
evaluation.
B.2 Reagents
SHEATH FLUID Sheath fluid for flow cytometer
CLEANING SOLUTION Cleaning solution for flow cytometer
B.4 Configuration
Configuration1 Configuration2 Configuration3
Optical Signal (2-laser, (2-laser, (2-laser,
4-color) 5-color) 6-color)
Forward scatter FSC √ √ √
Side scatter SSC √ √ √
Fluorescence FL1 (FITC)
√ √ √
channel 1
Fluorescence FL 2 (PE)
√ √ √
channel 2
Fluorescence FL 3 (PerCP)
√ √ √
channel 3
Fluorescence FL 4 (APC) √ √ √
B-1
Appendices
channel 4
Fluorescence FL 5 (PE-Cy7) / √ √
channel 5
Fluorescence FL 6 (APC-Cy7) / / √
channel 6
Remark √ indicates that the optical signal of this channel is included; / indicates that
the optical signal of this channel is not included.
Note: the content inside the brackets is the applicable fluorescein.
FITC: Fluoresceinisothiocyanate;
PE: R-phycoerythrin;
PerCP: Peridinin chlorophy Iiprotein;
APC: Allophycocyanin;
PE-Cy7: the conjugate of PE and Cy7 (a cyanine dye);
APC-Cy7: the conjugate of APC and Cy7.
B.4.1 Lasers
Blue laser: 488nm, red laser: 638nm
B.5 Parameters
T Lymphocyte % T%
T Helper Lymphocyte % CD4+T%
T Suppressor Lymphocyte % CD8+T%
B Lymphocyte % B%
B-2
Appendices
NK Lymphocyte % NK%
T Lymphocyte Absolute Count T#
+
T Helper Lymphocyte Absolute Count CD4 T#
+
T Suppressor Lymphocyte Absolute CD8 T#
Count
HLA-B27 HLA-B27
B.9 Performance
Item Performance Remarks
Fluorescence sensitivity FITC≤100 MESF Use Spherotech RCP-30-5A
PE≤50 MESF
particles
As an average result of
three BriCyte E6 (using
area signals)
FITC= 94MESF
PE=34MESF
Fluorescence linearity Correlation coefficient≥0.98 Use Spherotech RCP-30-5A
particles
Forward scatter sensitivity ≤1.0 μm Use Thermo Duke 3K1000
particles
Side scatter sensitivity ≤0.2 μm Use Thermo Duke 3K-200
particles
Precision FSC≤2.0%; Use Spherotech URFP -30-2
FITC≤2.0%; particles
B-3
Appendices
PE≤2.0%;
WARNING
When the performance of the cytometer changes significantly, contact our
service department to calibrate the cytometer if necessary.
B.10 Environment
Working Environment Storage Environment
B-4
Appendices
Parameter Description
Width(mm) 500±10
Depth(mm) 500±10
Height(mm) 550±10
Weight(Kg) ≤60
B.12 PC Configuration
CPU: Intel CoreTMi3 or higher
RAM: 4 GB or above
Hard disk: 500 GB or above
Display: recommended resolution 1920×1080 or higher
2 or more network interfaces, keyboard and mouse
Operating system: Windows 7 Professional(SP1)
B.14 Contraindication
None
B-5
Appendices
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-6
C Communication
C.1 Communication Requirements
C.1.1 Overview and Definition
There are 2 types of communication between LIS and MRFlow:
1-way communication: the communication between LIS and MRFlow is unidirectional, which
means LIS only receives and processes results sent by MRFlow, but does not send any
message to MRFlow. For MRFlow, it does not receive or process any command from the
outside
2-way communication: the communication between LIS and MRFlow is bi-directional, which
means LIS can receive data from MRFlow, as well as send certain sample information to
MRFlow. In this case, MRFlow can automatically obtain the panel and patient information of
the sample, reducing the repeated work of entering sample information. For MRFlow, it can
receive and correctly process the commands from LIS, and respond accordingly.
The LIS system which support bi-directional communication is called 2-way LIS, while the one
only supports uni-directional communication is called 1-way LIS. As for MRFlow, to support the
2-way communication between the instrument and the system, it should be able to receive and
send messages from LIS or other external system.
1-Way Communication Mode
The figure below shows the routine sample analysis workflow in 1-way communication mode.
Sample
(Collected at Send to Technician
Laboratory Test Order
sample collection (Sign for receival)
center)
Check or
other
measures
Analysis
Instrument
Send results No (run the sample
to HIS on the instrument)
HIS System
Yes
Checked? LIS System
Test Report
Print
The figure below shows the routine sample analysis workflow in 2-way communication mode.
C-1
In this workflow, MRFlow can get sample information (e.g. panel, patient information, etc.) by
sending request or receiving messages.
Scenarios description:
Compared with worklist downloading mode, in request mode, the software first identify the
sample, and send a worklist request to the external system using the sample ID or other
related information.
Workflow:
Sample Arrival
Request for
Analysis
sample test panel
LIS System Instrument
Send back (Sample
response to request identification)
C-2
memory. For example, at this time, the worklists are ready in the LIS system connected to the
flow cytometer.
Exception handling:
After the sample is identified, the software sends a request to search for the panel of the
sample using the sample ID. If the request fails (sample ID unidentifiable, or no match), do as
follows:
Scenarios description:
In this scenario, the instrument does not receive any order from the external system. When a
clinician issues a sample analysis order, the order is printed and sent to the laboratory, after
which the contents in the printed order will be entered in MRFlow.
Workflow:
Enter worklist
information
Analysis Instrument manually
Send test
results to
LIS Sample
arrival
Barcode
Analysis Instrument scanning, tube
position, or
(Sample identification)
manual entry
Analysis Instrument
(Sample analysis)
Exception handling:
If the worklist information of a sample is not entered into the instrument after the instrument
identified this sample, do as follows
C-3
1) Skip this sample or stop the current operation.
9) Support previous versions of the communication protocol: both the old version and
new version are applicable after update.
2) IP address: when MRFlow servers as the client, fill in with the IP address of the LIS
server; when MRFlow serves as the server, the address will be ignored.
3) Port: when MRFlow servers as the client, fill in the LIS server port; when MRFlow
serves as the server, fill in with the listening port name of the PC.
4) Protocol type: select the protocol and code type from "HL7" and "ASTM.
5) ACK synchronous communication: if this check box is selected, MRFlow will wait for
ACK after sending a sample result message, and send the next one until it receives
the ACK or an error message; if it is not selected, MRFlow sends the next message
immediately after the previous one is sent, and ignores the ACK messages sent from
LIS.
6) ACK timeout: this setting takes effect at the same time with the ACK synchronous
communication setting. It is the maximum time MRFlow waiting for the ACK message
after sending out a result message.
7) 2-way LIS/HIS: if this check box is selected, the software will request for sample
C-4
information after saving changed worklist, or before starting a count.
8) Auto transmit after check: if this check box is selected, the sample results will be
automatically transmitted after it is checked. (only checked sample can be
transmitted)
The OBR-4 (Universal Serview ID) field of HL7 is used to identify the type of the analysis result.
See the following table.
The PID (Patient Identification) segment of HL7 contains the patient demographic information.
The PV1 (Patient Visit) segment of HL7 contains the patient visit information. See the following
tables for the definitions.
C-5
Table 3 PV1 Field Definitions
The OBR (Observation Request) segment contains the test report information.
See the following table for field definitions in use.
C-6
BLDV: venous blood
BLDC: capillary blood
Results TS 26 Result report/Status
Rpt/Status
change - Tie.
Chng -
Date/Time + Used as the time of
validation.
Diagnostic Serv ID 10 Diagnosis maker ID; HM
Sect ID value: "HM" (means
Hematology)
Result Copies XCN 150 Copy the result to.
To Used as the person
who validate the
sample results.
Principal Result CM 200 Principal result Mindray
Interpreter +
interpreter.
Used as the operator
of the sample analysis
in sample messages.
Used as the operator
of the QC count in QC
messages.
The OBX (Observation/Result) segment contains the parameter information of each test result.
See the following table for the communication data.
HL7
Type Code Encode Example of
Data Name
(OBX (ID) Sys OBX-3 field
-2)
Non-parameter Data Items
08001^Project
Panel IS 05007 Project Type 99MRC
Type^99MRC
30525 30525-0^Age^LN
Age NM Age LN
~-0
01001^Remark^99
Remarks ST 01001 Remark 99MRC
MRC
01007^Sample
Sample type IS 01007 Sample Type 99MRC
Type^99MRC
01008^Patient
Inpatient zone IS 01008 Patient Area 99MRC
Area^99MRC
Custom patient ST 01009 Custom 99MRC 01009^Custom
C-7
information 1 patient info 1 patient info
1^99MRC
01010^Custom
Custom patient Custom
ST 01010 99MRC patient info
information 2 patient info 2
2^99MRC
01011^Custom
Custom patient Custom
ST 01011 99MRC patient info
information 3 patient info 3
3^99MRC
01014^Report
Report time ST 01014 Report Time 99MRC
Time^99MRC
01015^Charger
Payer ST 01015 Charger type 99MRC
type^99MRC
01016^Patient
Patient type ST 01016 Patient type 99MRC
type^99MRC
Parameter Result Items
731~- 731-0^LYM#^LN
LYM NM LYM# LN
0
20599 20599-7^T%^LN
T_PER NM T% LN
~-7
20598 20598-9^T#^LN
T NM T# LN
~-9
20593 20593-0^B%^LN
B_PER NM B% LN
~-0
20592 20592-2^B#^LN
B NM B# LN
~-2
20620 20620-1^NK%^LN
NK_PER NM NK% LN
~-1
26561 26561-1^NK#^LN
NK NM NK# LN
~-1
32516 32516-7^CD4+T%
CD4_T_PER_PER NM CD4+T%% LN
~-7 %^LN
32515 32515-9^CD4_T%
CD4_T_PER NM CD4+T%# LN
~-9 #^LN
32518 32518-3^CD8+T%
CD8_T_PER_PER NM CD8+T%% LN
~-3 %^LN
32517 32517-5^CD8+T%
CD8_T_PER NM CD8+T%# LN
~-5 #^LN
20607 CD4+T/CD8+ 20607-8^CD4+T/C
CD4_CD8_T NM LN
~-8 T D8+T^LN
26028 26028-1^HLA-B27
HLA-B27 NM HLA-B27 LN
~-1 ^LN
15000^
MFI(shift) NM 25000 MFI(shift) 99MRC
MFI(shift)^99MRC
B27-Cutoff NM 25001 B27-Cutoff 99MRC 15001^ B27-Cutoff
C-8
^99MRC
17146 CD4+CD8+% 17146-2^
CD4+CD8+%% NM LN
-2 % CD4+CD8+%%^LN
51755 51755-7^
CD4-CD8-%% NM CD4-CD8-%% LN
-7 CD4-CD8-%%^LN
C-9
C.2 Connection Control
C.2.1 MRFlow as TCP Server
The TCP server starts monitoring after the MRFlow is started up or the communication setup is
modified. It can accept one LIS connection which sustains until message transmission fails,
the communication setup is modified or the MRFlow is closed.
C-10
characters (like ENQ, ACK, NAK, EOT, etc.). To reduce the responding time, it is suggest
disabling the "No Delay" function.
Sending Message
Before data transmission, the sender needs to send ENQ to the receiver asking for
establishing a connection. The receiver will send back ACK if it is ready to receive data;
otherwise it will send NAK. When the sender receives ACK, it will get ready to send data since
the connection is successfully established; otherwise, it will end the data transmission. Figure
5shows the complete process of message transmission from MRFlow to LIS.
After the connection between MRFlow and LIS is established successfully, the MRFlow starts
sending data frames to LIS, and LIS responds with ACK if it has received data, or with NAK if it
wants MRFlow to resend the data. The EOT control character will be sent after the
communication is finished.
For transmission from LIS to MRFlow, the roles of the sender and receiver reverse. LIS sends
ENQ asking for establishing a connection, sends data frames after receiving ACK response,
and then waits for the ACK message for successful transmission.
A transmission refers to the transmission of one message (see C.4 for message definitions).
The data frames of a message consist of middle frame(s) and end frame. The end frame refers
to the last frame of the message; while the middle frame refers to other data frame(s) except
C-11
the end frame.
The response waiting time is 4 seconds. If there is no response within 4s, the connection
establishing is regarded as failed, and the communication ends.
Resending Message
In the process of data transmission, if LIS requires a data resending since there is error in the
received data frames or for other reasons, it will respond with NAK; if the sender still receives
NAK after resending the same data frame, the transmission will be regarded as failed and it will
end.
2-Way LIS
First, the MRFlow send a request message to LIS which is the same as that in the "sending
C-12
message" process; and then it waits the LIS to respond (see C.4 for message definitions) for
4s. The LIS responding process is the same as that in the "sending message" process.
C-13
C.3 HL7 Communication Protocol
C.3.1 Overview
The LIS/HIS communication function of the MRFlow enabled the communication between the
cytometer and the PC in laboratory through Ethernet, including sending analysis results to and
receiving worklist from lab PC.
This communication protocol is defined based on the HL7 Standards. HL7 is a series of
electronic data exchange standards for healthcare industry, which is originally defined by the
US and is now adopted worldwide. This protocol is defined based on HL7 v2.3.1. For details of
HL7 standards, see HL7 Interface Standards Version 2.3.1.
See C.5
HL7 Low-Level Message Protocol
HL7 of high-level protocol is based on messages. The function of terminating the message is
not provided. In order to determine the message boundary, the MLLP low-level protocol is
used (see HL7 Interface Standards Version 2.3.1).
Communication Level
Messages are transmitted in the following format:
<SB> ddddd <EB><CR>
among which:
C-14
Duplex Communication Process
1) The MRFlow directly sends the analysis results (or QC data) to LIS, as shown in the
figure below.
ORU^R01
MRFlow LIS
ACK^R01
ORM^O01
MRFlow LIS
ORR^O02
ORU^R01 message: it is mostly used for the transmission of the analysis results
and QC data.
ORU Observational Results (Unsolicited) Description
C-15
date of birth, etc.
[PV1] Patient visit information, including patient type, department, bed No. and
payer*, etc.
{
OBR sample information, including sample No., operator and time of
analysis, etc.
{[OBX]} analysis data, including analysis results and mode of
analysis, etc.
}
}
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
MRFlow requests LIS/HIS to re-fill the order message.
ORM General Order Message Dexription
C-16
C.3.4 HL7 Segment Definitions
The tables in this section provide detailed definitions of the fields in all the message segments.
Each row provides the information of one field, and the content of each column is described as
follows:
1. No.: the HL7 message begins with the segment name of 3 characters followed by the fields
which are separated by delimiters. "No." refers to the order of the field in the HL7
message segment.
E.g.
PID |1 | |7393670^^^^MR||^Liu||19950804000000|Female
↑ ↑ ↑
Segment name Field 1 Field 3
Note: for MSH segment, the field delimiter subsequential to the segment name is considered
to be the first field, used to define the field delimiter values of the whole message.
3. Data type: the data type based on HL7 standards. See C.5 for details.
4. Recommended max length: the recommended max length based on HL7 standards. But
during the communication process, the data length may be longer than recommended, in
which case the fields shall be identified by delimiters while analyzing the message
segment.
MSH
MSH (Message Header) segment contains basic information of HL7 messages, including
delimiter value, message type and coding method etc. It is the first field of every HL7 message.
Message example:
MSH|^~\&| MRFlow |Mindray|||20130419104618||ORU^R01|1|P|2.3.1||||||UNICODE
See the following table for definition of each field in MSH segment.
C-17
2 Encoding ST 4 Includes component ^~\&
Characters delimiters, repetition
delimiters, escape
delimiters and
subcomponent delimiters.
3 Sending EI 180 Application of sending MRFlow
application terminal.
4 Sending EI 180 Device of sending terminal. Mindray
Facility Value: Mindray
7 Date/Time TS 26 Time of creating the 2013041910461
Of message (in the format of 8
Message YYYY[MM[DD[HH[MM[SS]
]]]]), using the system time
9 Message CM 7 Message type, in the ORU^R01
Type format of "message
type^event type".
10 Message ST 20 Message control ID, used 1
Control ID as the unique identifier of a
message.
11 Processing PT 3 Message processing ID. P
ID
Value:
"P": sample and worklist
request message;
"Q": QC analysis result
message;
In Ack messages, it is
consistent with the
previously received
message.
12 Version ID VID 60 HL7 version number. 2.3.1
Value: "2.3.1".
18 Character ID 10 Character set. UNICODE
Set Value: "UNICODE", which
means the message in
communication is
expressed in UTF-8
strings.
MSA
C-18
Table 7 MSA Field Definitions
C-19
207 Application internal Other unknown error of the application
error
PID
The PID (Patient Identification) segment contains the patient demographic information.
Message example:
PID|1||C1^^^^MR||^Liu||20130419104618|F
See Table 4 for field definitions in use.
PV1
The PV1 (Patient Visit) segment contains the patient visit information.
C-20
Message example:
PV1|1|Outpatient|Medicine^^BN1|||||||||||||||||MedicalInsurance
See the following table for field definitions in use.
OBR
The OBR (Observation Request) segment contains the test report information.
Message example:
OBR|1|| TestSampleID1|00001^Automated Count^99MRC||20121207080000|201212071600
00|||Li|||Influenza|20121207083000||||||||||HM||||||||Mindray
See the following table for field definitions in use.
C-21
analysis results.
See the
configuration files
and C.7 Appendix:
Message Coding
Definition for values.
6 Requested TS 26 Draw time. 20121207080000
Date/time Used as the time
when the blood
sample is drawn.
7 Observation TS 26 Time of analysis. 20121207160000
Date/Time #
10 Collector XCN 60 Analysis orderer Li
Identifier * Here indicates the
person who orders
the analysis.
13 Relevant ST 300 Relevant clinical Influenza
Clinical Info.
information.
Can be used as the
clinical diagnostic
information of
patient information.
14 Specimen TS 26 Time when the 20121207083000
Received
sample is received.
Date/Time *
Used as the time
when the analysis is
ordered.
15 Specimen CM 300 Source of the
Source *
sample.
Value definitions in
HL7:
BLDV: venous blood
BLDC: capillary
blood
22 Results TS 26 Result report/Status
Rpt/Status
change - Tie.
Chng -
Date/Time + Used as the time of
validation.
24 Diagnostic ID 10 Diagnosis maker ID; HM
Serv Sect ID value: "HM" (means
Hematology)
28 Result Copies XCN 150 Copy the result to.
To Used as the person
who validate the
sample results.
32 Principal CM 200 Principal result Mindray
Result
interpreter.
C-22
Interpreter + Used as the
operator of the
sample analysis in
sample messages.
Used as the
operator of the QC
count in QC
messages.
OBX
The OBX (Observation/Result) segment contains the parameter information of each test result.
Message example:
OBX|8|NM|6690-2^WBC^LN||2.20|10*9/L|4.00-10.00|L~A|||F
See the following table for field definitions in use.
C-23
analysis parameters,
while Name is for
description purpose
rather than
identification.
5 Observatio * 65535 Analysis result data, 2.20
n Value which can be
numeric, string,
enumeration value,
binary data, etc. See
C.7 Appendix:
Message Coding
Definition for detailed
value definitions
(Binary data like
histogram or
scattergram are
converted to codes
using the Base64
coding method. See
C.8 Appendix:
Base64 Encoding
Process for the
coding method).
6 Units CE 90 Unit of analysis items. 10*9/L
Use ISO standard
units. See C.7
Appendix: Message
Coding Definition for
units used in
communication.
7 References ST 90 Reference range of 4.00~-10.00
Range analysis results, in the
form of "lower
limit-higher limit",
"<upper limit" or
">lower limit".
8 Abnormal ID 5 Analysis result flags. L~A
Flags
Value definitions:
"N": normal
"A": abnormal
"H": higher than upp
er limit
"L": lower than lower
limit
Note: The flag for
normal or abnormal
and that for high or
low result may appear
in this field at the
same time. In this
case, the two types of
flags are connected
by a ―~‖, e.g. ―H~A‖
C-24
11 Observ ID 1 Status of the analysis F
Result result. "F": final result.
Status
13 User ST 20 User-defined. For
Defined flags of reagent
Access expiration or
Checks modification, etc. In
the form of
"Flag1~Flag2".
There are 6 types of
flags in all:
O – reagent
expiration
E – result edited flag
e – result changed
due to the manual
editing of another
parameter result
based on which it is
calculated
C – result corrected
flag
V – result beyond
linear range flag
T – temperature
alarm flag
ORC
The ORC (Common Order) segment contains the common information of order.
Message example:
ORC|RF||SampleID||IP
See Table 8 for field definitions.
C-25
2 Placer EI 22 Code for order placer.
Order In ORM message, the
Number value is null. In ORR
message, the value is
the sample ID.
3 Filler EI 22 Code for order receiver. SampleID
OrderNum In ORM message, the
value is the sample ID.
In ORR message, the
value is null.
5 Order ID 2 Order status. IP
Status In ORM message of
worklist information
searching
communication, the
value is "IP", which
means "the order is
being processed, but
has no result yet"; in
ORR message, the
value is null.
MSH|^~\&|MRFlow|Mindray|||20130424094913||ORU^R01|1|P|2.3.1||||||UNICODE
PID|1||200456^^^^MR||^smith||20120430173815|male
PV1|1|patienttype|dept^^205||||||||||||||||| chargetype
OBR|1||1|00001^Automated
Count^99MRC||20130415173815|20130420125148|||sender|||Cold|20130416173815|samplet
ype|||||||20130424094852||HM||||Admin||||Admin
OBX|1|IS|05007^Project Type^99MRC||T/B/NK-Auto||||||F
OBX|2|NM|30525-0^Age^LN||1|yr|||||F
OBX|3|NM|20598-9^T#^LN||37037.000| events /ul|||||F
OBX|4|NM|20599-7^T%^LN||100.00|%|||||F
OBX|5|NM|20592-2^B#^LN||0.000| events /ul|||||F
OBX|6|NM|20593-0^B%^LN||0.00|%|||||F
BX|7|NM|20620-1^NK%^LN||0.00|%|||||F
OBX|8|NM|32515-9^CD4+T%#^LN||37037.000|events/ul|||||F
OBX|9|NM|32516-7^CD4+T%%^LN||100.00|%|||||F
OBX|10|NM|32517-5^CD8+T%#^LN||37025.000|events/ul|||||F
OBX|11|NM|32518-3^CD8+T%%^LN||99.97|%|||||F
OBX|12|NM|20607-8^CD4+T/CD8+T^LN||1.00||||||F
Sample Response Message
C-26
message which contains two segments: MSH and MSA. To send a correct response message,
take into consideration that: the MSH-9 field should be ACK^R01 which indicates that it is a
sample response message; If the value in the MSA-2 field is the same with the MSH-10 value
of the received analysis result, it indicates that this response message is corresponding to the
sent analysis result. The MSA-2 value in the following example is 1
MSH|^~\&|LIS||||20130424095049||ACK^R01|1|P|2.3.1||||||UNICODEMSA|AA|1
A 2-way LIS/HIS request message contains a sample ID. After the LIS/HIS received the
request message, it will search for the corresponding patient and sample information to
provide a response.
A request response message contains two segments: MSH and ORC. The MSH segment is
almost the same with that of the analysis result message, except that the MSH-9 value is
ORM^O01. The ORC-3 field should be filled with the receiver code (in this case, the sample ID;
where in the following sample, it is SampleID1). Note that in the autoloading analysis, if there
is a barcode scanning error while sending a request message, the sample ID will be ―Invalid‖.
An example of the request message is shown as follows:
MSH|^~\&|MRFlow|Mindray|||20130424095111||ORM^O01|2|P|2.3.1||||||UNICODEORC|R
F||1||IP
2-Way LIS/HIS Request Response Message
When the LIS received a request message, it needs to send back a request response
message. The first two message segments of the request response message are MSH and
MSA. The MSH-9 message type field (indicating the type of the segment) is filled with
ORR^O02, while the MSA segment should be filled up as shown in the following example of
the request response message. If the LIS/HIS gets searching results for the request, there will
be PID, PV1, ORC, OBR and OBX message segments after the two heading segments to
provide the patient and sample information, in the same way as the sample data message
does. The ORC segment is indispensable for a request response message with searching
results, in which the ORC-1 value is AF, and ORC-2 is the key searching field(the sample ID).
Note that the OBR-2 field indicates the sample ID, which should be the same as in the ORC-2
field; otherwise, the message will be regarded as incorrect.
An example of the request response message with searching results is shown as follows:
MSH|^~\&|LIS|LISSimulator|||20130424095815||ORR^O02|0|P|2.3.1||||||UNICODE
MSA|AA|1||||
PID|1||20123^^^^MR||LastName^fisrtName||20120422192223|male
C-27
PV1|1|waike|dept45^^234|||||||||||||||||gongfei
ORC|AF|1
OBR|1|1||00001^Automated
Count^99MRC||20130422091323||||sender||||20130422185915||||||||||HM
OBX|1|IS|05007^Project Type^99MRC||CD348||||||F
OBX|2|NM|30525-0^Age^LN||12|d|||||F
OBX|3|ST|01001^Remark^99MRC||||||||F
An example of the request 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 request was rejected; if it is ―AE", then there is an error in the request
process.
MSH|^~\&|LIS||||20130424095815||ORR^O02|1|P|2.3.1||||||UNICODEMSA|AR|9
C-28
C.4 ASTM Communication Protocol
C.4.1 ASTM Protocol Overview
See the ASTM protocol documents for details of the protocol:
NCCLS LIS1-A (formerly ASTM 1381-02): Data Link Protocol
NCCLS LIS2-A (formerly 1394-97): Message Structure Protocol
Note: the characters used in ASTM protocol are standard ASCII characters (ISO 8859-1:
1987) unless there is a note for exception.
Message: A complete data package is called message. It is a set of information, which can be
a sample analysis result, QC result or request information. Message is the unit of a call for
communication.
Frame: the component of a message which is the unit of communication control and
communication error identification.
The ASTM communication protocol is a protocol based on TCP/IP protocol and serial port
communication control. ASTM protocol has two layers: the low-level protocol for message
transmission, and message level protocol between MRFlow and LIS.
Frame structure:
<STX> FN Text [<ETB>|<ETX>] C1 C2 <CR><LF>
C-29
STX: text transmission start control character;
FN: serial number of the frame, use numbers from 0 to 7 in turn (starting from 1) to identify
different frames;
Text: content of the message;
ETB: end character for text in the middle frame;
ETX: end character for text in the end frame;
C1: first-4-bit value of the check sum, expressed by 0-9 and A-F;
C2: last-4-bit value of the check sum, expressed by 0-9 and A-F;
CR: frame end "carriage return" control character
LF: frame end "line feed" control character;
Control Character
Middle Frame
C-30
In the frame <STX> FN text [<ETB>|<ETX>] C1 C2 <CR> <LF>, add every
character value from FN to text(note: do not add <STX>, [<ETB>|<ETX>], C1, C2, <CR> and
<LF>), divide the sum by 256, get the remainder, and convert it to 8bit where the 4 most
significant bits (first 4 bits) are C1, and the 4 least significant bits (last 4 bits) are C2. E.g.
01111010, convert it to hexadecimal, that is 7A, then C1 = "7", C2 = "A".
For example, ―<STX>1L|1|N<CR><ETB>01<CR><LF>‖, FN corresponds to the string“1”
,text
corresponds to the string “L|1|N<CR>”; If utf8 code system and hexadecimal are adopted,
the value of FN is 0x31,and the value of text is: 0x4C,0x7C,0x31,0x7C,0x4E and 0x0D.
The sum is 0x201,which is divided by 256 and the remainder is 0x01. According to ASTM
protocol, 0x01will be converted to ASCII code,thus C1=‗0‘,C2=‗1‘. Note that ‗0‘and ‗1‘are
chars and the hexadecimal values are 0x30 and 0x31.
Message
Record 00 Record 01 Record
##
Field 00 Field Field 00 Field …
## ##
Component … Component ... Component …… Component … …
00 ## 00 ##
Message: a set of records from message header record (H) to message terminator record
(T).
Record: a set of fields. It has information about a certain subject, e.g. patient information.
The first field of each record is the record type field.
Field: a set of components. The description of special property of the record, e.g. date of
birth in patient information.
Component: basic unit of message data. E.g. for patient name, it consists of two basic
units, Last Name and First Name which are separated by component delimiter.
Message Coding
C-31
Supported characters: 7, 9, 11, 12, 13, 32-126, 128-254
Unsupported characters: 0-6, 8, 10, 14-31, 127, 255
In the communication process, it is not allowed to use the following characters since they are
used as control characters:
<STX>, <EOT>, <ENQ>, <ACK>, <NAK>, <ETB>, <ETX>, <CR>, <LF>.
Considering communication between different platforms, the characters which are not in ASCII
standard character set are coded using UTF-8.
Delimiter
In a complete message, all the records shall be ended with <CR> (carriage return).
To identify different components, fields, or repeated texts in a record, different delimiters are
used between fields, components, and repeated texts.
ASTM uses the following ASCII characters:
Record end character <CR> Carriage return character (invisible)
Field delimiter |
Repetition delimiter \
Component delimiter ^
1) Transmission of delimiter:
The delimiter definition is in the second field of the message header record, normally in the
format "H | \ˆ & |", where H is the record type identifier, followed by 4 delimiter definitions, and
the last '|' is a field delimiter, indicating what follows is another field. The delimiters are in the
C-32
following order: field delimiter, repetition delimiter, component delimiter and escape delimiter.
2) Null delimiter:
For null field or component, if it is the last one, delimiter is not needed; if not, a delimiter for this
field/component is needed to separate it from the following field/component. That is to say, in a
record, the position of a field or a component matters. So even if a field/component is null, the
position shall be reserved by using a delimiter.
Note: according to the ASTM standard, the position of a null field/component shall be reserved
rather than being omitted.
Escape Character
While transmitting data, there may be protocol control characters or other characters that are
not allowed to transmit. In this case, these characters need to be converted to escape
character.
According to the escape character conversion rules in the ASTM standard, the escape
characters needed in message transmission are shown as follows:
Escape sequence Delimiter Remarks
&F& | Field delimiter
&R& \ Repetition delimiter
&S& ^ Component delimiter
&E& & Escape delimiter
Escape characters of low-level protocol control characters:
Escape sequence Delimiter Remarks
&X5& <ENQ>
&X4& <EOT>
&X2& <STX>
&X17& <ETB>
&X3& <ETX>
&XD& <CR>
&XA& <LF>
&X6& <ACK>
&X15& <NAK>
Note: in a message, the record terminator character (<CR>) is the protocol control character
which does not need to be converted.
C-33
Record Type
Special Notice
1. Time:
Format of time:
Date: YYYYMMDD
Date+Time: YYYYMMDDHHMMSS
2. Record sequence number:
In the message level protocol, all records except message header records begin with two
fields: "Record Type ID" and "Sequence Number".
Record Type ID: record type identifier. E.g. the record type ID for patient information is "P".
Sequence Number: record sequence number, numeric string, indicating the sequence number
of the record among all records of the same type. E.g.: if there are 2 "O" records, 3 "R"
records in a message, then the sequence number of the first "O" record is "1", and the second
one "2"; the sequence number of the first, second and third "R" records are "1", "2" and "3"
respectively. If there are more records of the same type, the sequence number increases
accordingly.
C-34
Message Header and terminator Records
C-35
Termination Code 3 N Termination code; value: "N"; fixed
A complete message terminator record is shown as follows:
L|1|N<CR>
Mainly includes patient ID, patient name, date of birth, age, physician, department, etc.
Used in sample analysis result message and worklist request response message.
The record of analysis sequence number, usually followed by result record. Commonly , a Test
C-36
Order Record contains sample sequence number and related information of analysis result
messages (including both sample analysis results and QC results)
C-37
Contains sample analysis result/QC result/extend information.
Since the default fields of Patient Information Record and Test Order Record cannot meet our
requirements of sample information/patient information/sample result/QC information
transmission, Result Record is used to bring extra fields for transmission. See C.4.4Message
Code for extended codes. For extended information items, only message ID and result are
needed.
Result Record is used in messages other than worklist searching messages.
C-38
Result corrected flag C C - Result corrected flag
Null if not corrected
Out of linearity range V V - out of linearity range
flag Null if within range
Complete record example:
R|14|^WBC^^6690-2|2.30|10&S&9/L|4.00^12.00|L^e^N^O^T^C^V<CR>
1) Record Structure
Record Structure:
1 Header
2 Patient
3 Order
4 Result1
5 Result2
6 Result3
......
C-39
n Message Terminator
C-40
received
16: sample type Sample type What displayed on
screen
Sample source Reserved; null
17: operator Operator What displayed on
screen
19: validater Validater What displayed on
screen
20: time of Checked at: YYYYMMDDHHMMSS;
validation what displayed on
screen
23: Report time Report time YYYYMMDDHHMMSS;
what displayed on
screen
26: report type Result F, fixed
R Inspection Item 2: ID ID See C.7 Table 16 Data
type and Coding
system
ID See C.7 Table 16 Data
type and Coding
system
4: result Panel See C.7 Table 18 HL7
and ASTM Enumeration
Definitions
5: unit Null
6: reference Null
range
7: flag Null
R Payer 4: result, value displayed on screen; value same as above
R Patient type 4: result, value displayed on screen; value same as above
R LYM: Lymphocyte 2: ID; format same as above; see data type and coding system
number in C.7 for the value
4: result Sample Analysis What displayed on
Result screen
5: unit Unit of sample What displayed on
analysis result screen
6: reference Upper limit What displayed on
range screen
Lower limit What displayed on
screen
7: flag Null
R T_PER# T Lymphocyte %: value same as above
R T T Lymphocyte Absolute Count: value same as above
C-41
R B_PER B Lymphocyte %: value same as above
R B B Lymphocyte Absolute Count: value same as above
R NK_PER NK Lymphocyte %: value same as above
R NK NK Lymphocyte Absolute Count: value same as above
R CD4_T_PER_PER T Helper Lymphocyte %: value same as above
R CD4_T_PER T Helper Lymphocyte Absolute Count: value same as above
R CD8_T_PER_PER T Suppressor Lymphocyte %: value same as above
R CD8_T_PER T Suppressor Lymphocyte Absolute Count: value same as
above
R CD4_CD8_T T Helper/ Suppressor Ratio: value same as above
R HLA-B27 #B27 negative: value same as above
1) Record Structure
Record Structure:
1 Header
2 Request
3 Message Terminator
C-42
Record Record Field Position: Component Value Value Description
Type Value Content
H Message 3: message ID Message ID Message ID, which is
Header also used in analysis
Record result messages
12: message type Worklist search See the table of OBR-4
code*
Q Request 3: Sample ID Sample ID What displayed on
information screen
7: time of request Time of request YYYYMMDDHHMMSS;
time when the message
is generated
request^00010|P|LIS2-A2|20130425092450<CR><ETX>AD<CR><LF><STX>2Q|1|1||||2013042509245
0<CR><ETX>9F<CR><LF><STX>3L|1|N<CR><ETX>03<CR><LF>
2-Way LIS Response Message
1) Record Structure
Record Structure:
1 Header
2 Patient
3 Order
4 Result1
5 Result2
6 Result3
......
n Message Terminator
C-43
8: date of birth Date of birth YYYYMMDDHHMMSS
Age
Age unit Available age units: null,
Y, M, W, D, and H,
indicating null, year,
month, week, day, and
hour respectively
9: gender Gender What displayed on
screen
25: department Department What displayed on
screen
26: location Inpatient zone What displayed on
screen
Bed No. What displayed on
screen
O Sample 3: Sample ID Sample ID ID of the requested
Information sample
8: Time of sample Time of sample YYYYMMDDHHMMSS
collection collection
11: The person The person who String in UI
who ordered the ordered the
analysis analysis
14: clinical Clinical diagnosis What displayed on
diagnosis screen
15: Date/Time Date/Time when YYYYMMDDHHMMSS;
when the the specimen is what displayed on
specimen is received screen
received
16: sample type Sample type What displayed on
screen
Sample source Reserved; null
26: report type Result of request Q – result of request is
found
Y – result of request is
not found
R Panel 2: ID ID See C.7 Table 16 Data
type and Coding system
ID See C.7 Table 16 Data
type and Coding
system
4: result Panel See C.7 Table 18 HL7
and ASTM Enumeration
Definitions
5: unit Null
C-44
6: reference range Null
7: flag Null
R Remarks 4: result, value displayed on screen; value same as above
R Payer 4: result, value displayed on screen; value same as above
R Patient type 4: result, value displayed on screen; value same as above
C-45
C.5 Appendix: HL7 Protocol Overview
C.5.1 Message Constructing Principles
Every HL7 message consists of several segments, each of which ends up with the <CR>
(0x0D).
Each segment consists of the segment name of three characters and a number of fields, and
each field consists of some components and subcomponents. For each message, the
delimiters of the fields, components and subcomponents are defined in the MSH segment.
E.g.
MSH|^~\&| MRFlow| Mindray|||20060427194802||ORU^R01|1|P|2.3.1||||||UNICODE
Among which:
The five characters following MSH define the delimiters used between fields, components and
subcomponents. Although they can be any non-text characters, HL7 standard recommends
you use the characters in the table below:
Character Meaning
| Field delimiter
^ Component delimiter
& Subcomponent delimiter
~ Repetition delimiter
\ ESC
The first two fields of MSH contain all the delimiters. Some fields behind are null because they
are optional and not used by Mindray HL7 interface. Details about field definition and selection
will be stated in the following sections.
For message of any type, the segments behind MSH appear in a fixed order. The order will be
described in the following sections and the following grammar is used to organize the
segments in proper order.
[] encloses optional segments.
{ } encloses segments which can repeat once or more.
C-46
for escape character conversion for HL7 interface are as follows:
ESC Sequence Original Character
\F\ Field delimiter
\S\ Component delimiter
\T\ Subcomponent delimiter
\R\ Repetition delimiter
\E\ Escape delimiter
\.br\ <CR>, segment end character.
Note: the "\" in the escape sequence represents the ESC delimiter, whose value is defined in
the MSH segment.
C-47
C.6 Appendix: HL7 Data Type Definition
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
Format defined by the field.
ED – Encapsulate Data
<source application(HD)> ^ <type of data(ID)> ^ <data sub type(ID)> ^ <encoding(ID)>
^ <data(ST)>
EI - Entity Identifier
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID (ST)> ^ <universal ID type (ID)>
FC – Financial Class
<financial class(IS)> ^ <effective date(TS)>
HD - Hierarchic designator
<namespace ID (IS)> ^ <universal ID (ST)> ^ <universal ID type (ID)>
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-48
NM - Numeric
A number represented as a series of ASCII numeric characters consisting of an optional
leading sign (+ or -), the digits and an optional decimal point.
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
<processing ID (ID)> ^ <processing mode (ID)>
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
C-49
C.7 Appendix: Message Coding Definition
1. In HL communication messages, the OBR-4 (Universal Serview ID) field, in the form of
―ID^Name^EncodeSys‖, is used to identify the type of the analysis result (e.g. sample analysis
result, microscopic examination result, QC result, etc.). The following table lists all the codes of
this field.
2. Each OBX segment contains information of one analysis parameter or non-parameter data
item. It consists of the following fields: OBX-2, indicating the type of the HL7 data contained;
OBX-3 (Observation Identifier), the identifier of the data in the form of ―ID^Name^EncodeSys‖;
OBX-5, containing the value of the data; OBX-6, containing the unit for the parameter, (in the
standard unit recommended by HL7).
Table 16 lists the HL7 type and code identifier of each communication data item. Table 17 lists
all the units for parameters in the communication.
HL7
Type Code Encode Example of
Data Name
(OBX (ID) Sys OBX-3 field
-2)
Non-parameter Data Items
08001^Project
Panel IS 05007 Project Type 99MRC
Type^99MRC
30525 30525-0^Age^LN
Age NM Age LN
~-0
01001^Remark^99
Remarks ST 01001 Remark 99MRC
MRC
01007^Sample
Sample type IS 01007 Sample Type 99MRC
Type^99MRC
01008^Patient
Inpatient zone IS 01008 Patient Area 99MRC
Area^99MRC
C-50
01009^Custom
Custom patient Custom
ST 01009 99MRC patient info
information 1 patient info 1
1^99MRC
01010^Custom
Custom patient Custom
ST 01010 99MRC patient info
information 2 patient info 2
2^99MRC
01011^Custom
Custom patient Custom
ST 01011 99MRC patient info
information 3 patient info 3
3^99MRC
01014^Report
Report time ST 01014 Report Time 99MRC
Time^99MRC
01015^Charger
Payer ST 01015 Charger type 99MRC
type^99MRC
01016^Patient
Patient type ST 01016 Patient type 99MRC
type^99MRC
Parameter Result Items
LYM NM 731-0 LYM# LN 731-0^LYM#^LN
20599 20599-7^T%^LN
T_PER NM T% LN
-7
20598 20598-9^T#^LN
T NM T# LN
-9
20593 20593-0^B%^LN
B_PER NM B% LN
-0
20592 20592-2^B#^LN
B NM B# LN
-2
20620 20620-1^NK%^LN
NK_PER NM NK% LN
-1
26561 26561-1^NK#^LN
NK NM NK# LN
-1
32516 32516-7^CD4+T%
CD4_T_PER_PER NM CD4+T%% LN
-7 %^LN
32515 32515-9^CD4_T%
CD4_T_PER NM CD4+T%# LN
-9 #^LN
32518 32518-3^CD8+T%
CD8_T_PER_PER NM CD8+T%% LN
-3 %^LN
32517 32517-5^CD8+T%
CD8_T_PER NM CD8+T%# LN
-5 #^LN
20607 CD4+T/CD8+ 20607-8^CD4+T/C
CD4_CD8_T NM LN
-8 T D8+T^LN
26028 26028-1^HLA-B27
HLA-B27 NM HLA-B27 LN
-1 ^LN
15000^
MFI_SHIFT NM 25000 MFI(shift) 99MRC
MFI(shift)^99MRC
B27_CUT_OFF NM 25001 B27-Cutoff 99MRC 15001^ B27-Cutoff
C-51
^99MRC
CD4_CD8_POS_P 17146 CD4+CD8+% 17146-2^
NM LN
ER -2 % CD4+CD8+%%^LN
CD4_CD8_NEG_P 51755 51755-7^
NM CD4-CD8-%% LN
ER -7 CD4-CD8-%%^LN
3. Some OBX messages use custom enumeration values. See Table 13 for the meaning of the
values.
4. Communication of patient age: the age of the patient is transmitted in an OBX segment
which contains an integer and a unit. The age could be "<1" day (same as the MRFlow
UI).
C-52
C.8 Appendix: Base64 Encoding Process
1. Select the 3 adjacent bytes (i.e. 24 bit) from the data stream to be encoded; from left to right,
divide them into 4 6-bit groups; and then, the ASCII string is obtained by mapping based on the
following table.
C-53
Data obtained after complementing 00001010 00001011 00000000
6-bit groups obtained after dividing 000010 10 0000 101100 000000
Corresponding codes 02H 20H 2CH 00H
Corresponding characters C g s =
C-54
D Accessories
Supplies in the Accessory Kit
0000-10-10807 2.5mm hex wrench
0000-10-11009 Connection Cable
047-013711-00 Label for waste container
048-002941-00 Reagent container(5L)
043-003209-00 Centrifugal tube adapter
043-002899-00 Leakage tray
105-005732-00 Cleaning Solution(EN)
105-005730-00 Sheath Fluid(EN/5L×1)
003B-20-72355-52 500mL/1000mL Bottle black cap
115-017546-00 Filter assembly
Optional Parts and Materials
0020-20-12522 Cable, power (International)
0020-20-12523 Cable, power(US)
DA8K-10-14453 U.K. power cord
009-001075-00 Brazil power cord 250V 10A 3M
023-000252-00 2D Bar Code Scanner
009-001397-00 USB cable of ASYMBOL scanner
115-017554-00 ECD/PI configuration package
115-017496-00 Carousel assembly
047-010578-00 Carousel ID label
041-007925-00 Debug stick
041-007903-00 Pole for prop
0020-20-12524 Cable, power(EU)
115-023949-00 Autoloader
115-023523-00 Optical upgrade kit(4 to 5 channel)
115-023524-00 Optical upgrade kit (4 to 6 channel)
115-023525-00 Optical upgrade kit (5 to 6 channel)
D-55
P/N: 046-006303-00(4.0)