2015 - 12 - 1114 - 24 - 22BriCyte - E6 - Operator's Manual - V4.0 - EN

BriCyte E6
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.
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called

Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
are the trademarks, registered or otherwise, of Mindray in

China and other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
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.
 This cytometer must be operated by skilled/trained clinical professionals.
 It is important for the hospital or organization that employs this cytometer to

carry out a reasonable service/maintenance plan. Neglect of this may result
in machine breakdown or injury of human health.
 Be sure to operate the cytometer under the situation specified in this
manual; otherwise, the cytometer will not work normally and the analysis
results will be unreliable, which would damage the cytometer components
and cause personal injury.
II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
 Malfunction of the instrument or part whose serial number is not legible enough.
 Others not caused by instrument or part itself.
Customer Service Department
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building,Keji 12th Road South,High-tech industrial
park,Nanshan,Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail service@mindray.com
Address:
Tel: +86 755 81888998
Fax: +86 755 26582680
III
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
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
2 Understanding Your Cytometer ....................................................................... 2-1

2.1 Introduction ........................................................................................................ 2-1
2.2 Parameters ........................................................................................................ 2-2
2.3 Hardware ........................................................................................................... 2-3
2.3.1 Overview............................................................................................... 2-3
2.3.2 Major Modules and Components ........................................................... 2-4
2.3.3 Cytometer ........................................................................................... 2-11
2.3.4 Peripherals.......................................................................................... 2-12
2.4 User Interface .................................................................................................. 2-13
2.5 Software Operation .......................................................................................... 2-15
2.6 Analysis Tools .................................................................................................. 2-23
2.6.1 Graphs ................................................................................................ 2-23
2.6.2 Gates .................................................................................................. 2-30
2.6.3 Statistics.............................................................................................. 2-34
2.7 About and Register for Other Computer ........................................................... 2-38
2.7.1 About .................................................................................................. 2-38
2.7.2 Register for other Computer ................................................................ 2-38
2.8 Reagents, Controls and Calibrators .................................................................. 2-39
2.8.1 Reagent .............................................................................................. 2-39
2.8.2 Fluorescence Setup Particles .............................................................. 2-40
3 Understanding the System Principles............................................................. 3-1

3.1 Introduction ........................................................................................................ 3-1
3.2 Fluidic Principle.................................................................................................. 3-2
3.2.1 Formation of Sample Flow..................................................................... 3-2
3.2.2 Change of Flow Rate............................................................................. 3-2
3.2.3 Flow Measurement ................................................................................ 3-3
3.3 Optical Principle ................................................................................................. 3-4
3.3.1 Optical Excitation .................................................................................. 3-4
3.3.2 Optical Detection ................................................................................... 3-4
3.4 Control and Signal Processing ........................................................................... 3-7
3.4.1 Preamplification Unit ............................................................................. 3-7
3.4.2 Main Control Unit .................................................................................. 3-7
1
Table of Contents
3.4.3 Drive and Monitor Unit ........................................................................... 3-8

3.4.4 Power Unit ............................................................................................ 3-8
4 Installing Your Cytometer ................................................................................ 4-1

4.1 Introduction ........................................................................................................ 4-1
4.2 Installation Requirements ................................................................................... 4-2
4.2.1 Space Requirements ............................................................................. 4-2
4.2.2 Power Requirements ............................................................................. 4-2
4.2.3 General Environment ............................................................................ 4-3
4.2.4 Moving and Installing the Cytometer ...................................................... 4-4
4.3 Connecting the Cytometer System ..................................................................... 4-5
4.3.1 Reagents .............................................................................................. 4-5
4.3.2 Connecting the Analysis System ............................................................ 4-5
4.4 Software Register .............................................................................................. 4-7
4.4.1 Local Register ....................................................................................... 4-8
4.4.2 Non-local Register ................................................................................. 4-8
5 Customizing the Cytometer Software ............................................................. 5-1

5.1 Introduction ........................................................................................................ 5-1
5.2 Setup ................................................................................................................. 5-2
5.2.1 Host Setup ............................................................................................ 5-2
5.2.2 Graph Parameters................................................................................. 5-6
5.2.3 User Management ................................................................................. 5-7
5.2.4 Communication Setup ......................................................................... 5-12
5.2.5 Print Setup .......................................................................................... 5-13
5.2.6 Templates ........................................................................................... 5-14
5.2.7 Lab Info. .............................................................................................. 5-15
5.2.8 Reagent Setup .................................................................................... 5-17
5.2.9 Preference Setup ................................................................................ 5-17
6 Operating Your Cytometer ............................................................................... 6-1

6.1 Introduction ........................................................................................................ 6-1
6.2 Initial Checks ..................................................................................................... 6-2
6.3 Startup and Login ............................................................................................... 6-4
6.4 Daily Quality Control .......................................................................................... 6-6
6.5 Preparing Samples ............................................................................................ 6-7
6.5.1 Applicable Tubes ................................................................................... 6-7
6.5.2 Preparing Samples................................................................................ 6-8
6.6 Entering Worklist Information ........................................................................... 6-10
6.6.1 Basic Sample Information.................................................................... 6-10
6.6.2 Extended Sample and Patient Information ........................................... 6-12
6.7 Creating Templates .......................................................................................... 6-16
6.7.1 Editing Templates ................................................................................ 6-16
6.7.2 Saving Template.................................................................................. 6-26
2
Table of Contents
6.8 Running Samples - Manual Loading ................................................................. 6-28

6.8.1 Before Running Samples..................................................................... 6-28
6.8.2 Running Samples ................................................................................ 6-29
6.9 Running Samples - Auto Loading ..................................................................... 6-35
6.9.1 Running Samples - Batch Mode .......................................................... 6-36
6.9.2 Running Samples - Single-tube Mode.................................................. 6-45
6.10 Auto Adjustment Tools...................................................................................... 6-51
6.10.1 Auto Adjustment of Voltage .......................................................... 6-51
6.10.2 Auto Adjustment of Compensation (Based on Plot) ...................... 6-52
6.10.3 Auto Compensation (Based on Single-Stained Tubes) .................. 6-55
6.11 Analyzing Results ............................................................................................ 6-58
6.11.1 Worklist........................................................................................ 6-58
6.11.2 Sample Analysis .......................................................................... 6-71
6.11.3 Backup and Restoration ............................................................... 6-83
6.12 Standby ........................................................................................................... 6-85
6.13 Shutdown......................................................................................................... 6-86
7 Using the QC Programs ................................................................................... 7-1

7.1 Introduction ........................................................................................................ 7-1
7.2 Auto Setup ......................................................................................................... 7-2
7.2.1 Information ............................................................................................ 7-2
7.2.2 Auto setup............................................................................................. 7-6
7.2.3 Auto setup L-J Graph ............................................................................ 7-9
7.3 Parameter QC.................................................................................................. 7-11
7.3.1 Control Information.............................................................................. 7-11
7.3.2 QC Analysis ........................................................................................ 7-13
7.3.3 QC Review.......................................................................................... 7-14
8 Servicing Your Cytometer................................................................................ 8-1

8.1 Introduction ........................................................................................................ 8-1
8.2 Reagent Management........................................................................................ 8-2
8.3 Maintenance ...................................................................................................... 8-4
8.3.1 When to Maintain .................................................................................. 8-4
8.3.2 Tools Required for Maintenance ............................................................ 8-5
8.3.3 De-gas .................................................................................................. 8-5
8.3.4 Cleaning................................................................................................ 8-6
8.3.5 Unclogging ............................................................................................ 8-7
8.3.6 Priming ................................................................................................. 8-7
8.4 Status ................................................................................................................ 8-9
8.4.1 Fluidics ............................................................................................... 8-10
8.4.2 Red laser ............................................................................................ 8-11
8.4.3 Blue laser ............................................................................................ 8-11
8.4.4 Other temperatures ............................................................................. 8-11
8.4.5 Circuit system ..................................................................................... 8-11
3
Table of Contents
8.4.6 Photocoupler and switch ..................................................................... 8-12

8.5 Self-Test .......................................................................................................... 8-13
8.5.1 Self-test of indicators ........................................................................... 8-13
8.5.2 Self-test of moving components ........................................................... 8-14
8.5.3 Valve Self-test ..................................................................................... 8-16
8.5.4 Self-test of optical system.................................................................... 8-16
8.5.5 Self-test of fluidics system ................................................................... 8-17
8.6 How to Replace ............................................................................................... 8-20
8.6.1 When to Replace................................................................................. 8-20
8.6.2 How to Replace ................................................................................... 8-20
8.7 Log .................................................................................................................. 8-24
8.7.1 Viewing Logs....................................................................................... 8-24
8.7.2 Exporting Logs .................................................................................... 8-25
9 Troubleshooting ............................................................................................... 9-1

9.1 Introduction ........................................................................................................ 9-1
9.2 Error Information ................................................................................................ 9-2
9.3 Other Errors ..................................................................................................... 9-12
10 Appendices ..................................................................................................... A-1
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.
1-1
Using This Manual
1.2 Who Should Read This Manual

This manual is intended to be read by clinical laboratory professionals to:
 learn about the BriCyte E6 hardware and software;
 set up system parameters;
 perform daily operating task;
 perform system maintenance and troubleshooting.
1-2
Using This Manual
1.3 How to Find Information

This operator‘s manual comprises 9 chapters and 4 appendices. Refer to the table below to
find the information you need.
If you want to … See...

Learn about the intended use and the test Chapter 2 Understanding the
parameters of the BriCyte E6; Cytometer
Lear about the components and operation interface Chapter 2 Understanding the
of the BriCyte E6 Cytometer
Know about the system principles and workflow of Chapter 3 Understanding the
the BriCyte E6 System Principles
learn about the installation requirements of the Chapter 4 Installing Your
BriCyte E6 Cytometer
Know about how to define/adjust system settings of Chapter 5 Customizing the
the BriCyte E6 software Cytometer Software
Learn about the process of sample collection, Chapter 6 Operating Your
preparation and analysis Cytometer
Completing daily operations with your BriCyte E6 Chapter 6 Operating Your
Cytometer
Learn about how to perform quality control and Chapter 7 Quality Control
calibration
learn about how to service and test the BriCyte E6 Chapter 8 Servicing Your
Cytometer
learn about how to solve the problems of the BriCyte Chapter 9 Troubleshooting
E6
learn about the technical specifications of the BriCyte Appendix B Specification
E6
learn about the communication protocol of the Appendix C Communication
BriCyte E6
1-3
Using This Manual
1.4 Conventions Used in This Manual

This manual uses certain typographical conventions to clarify meaning in the text:
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.
1-4
Using This Manual
1.5 Precautions, Limitations and Hazards

The following symbols are used to indicate danger and alert information in this manual.
Symbols Meaning
read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.

WARNING alerting you to an operating hazard that can cause
personnel injury.
CAUTION alerting you to a possibility of system damage or unreliable
analysis results.
NOTE alerting you to information that requires your attention.
 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.
1-5
Using This Manual
WARNING
 This cytometer must be operated by skilled/trained clinical professionals.
 It is important for the hospital or organization that employs this cytometer to

carry out a reasonable service/maintenance plan. Neglect of this may result
in machine breakdown or injury of human health.
 Be sure to operate the cytometer under the situation specified in this
manual; otherwise, the cytometer will not work normally and the analysis
results will be unreliable, which would damage the cytometer components
and cause personal injury.
 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.
 Please take action to any alarm and problem indication immediately.
 Do not touch the moving parts.

 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.
 Contact the manufacturer or authorized distributors in time if any damaged

part is found.
 Be careful when opening/closing and removing/installing the doors, covers
and boards of the system.
 Discard the cytometer according to government regulations.

 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 hazards while
transporting or servicing the cytometer.
 The installation, authorization, upgrade and modification of the cytometer
and software must be performed by personnel authorized by the
manufacturer.
 Make sure the cytometer is properly grounded.
 Before turning on the cytometer, make sure the input voltage meets the
requirement.
 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 cytometer is supposed to be moved by several people together because
of its weight. Safety procedures should be followed and applicable tools
1-6
Using This Manual
should be used, in order to prevent from human injury.

 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.
 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.
 Keep your clothes, hair and hands away from the moving parts to avoid
injury.
 Avoid direct contact with patient samples.
 The sample probe may contain biohazardous materials. Exercise caution to

avoid contact with the probe when working around it.
 Each tube must be exactly in the carousel position specified in the worklist
to avoid incorrect results.
 Do not try to pull the autoloader door open forcefully when it is locked.
 Be sure to back up important data regularly in case of data loss by accident.

 When replacing the waste container, take out the tube from the waste
container only when the indicator of the cytometer is static, in order to
prevent from waste blowout.
 When the performance of the cytometer changes significantly, contact our

service department to calibrate the cytometer if necessary.
1-7
Using This Manual
CAUTION
 Please use the cytometer strictly as instructed by this manual.
 Install software authorized by the manufacturer only on the PC.

 Please only install genuine software to prevent the computer from virus.
 Take proper measures to prevent the reagents from contamination.

 It is recommended that you install anti-virus software on the computer and
scan for viruses periodically.
 During the daily use of the cytometer, especially the cleaning process, the
operator shall ensure the intactness of the labels.
 Do not power on and off the cytometer repeatedly in a short time; otherwise,
the cytometer may be damaged.
 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 cytometer damage or
unqualified smear output.
 After the autoloader (if configured) is installed, 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.
 Do not re-use disposable products.
 After you shut down the cytometer, wait for at least 10 seconds before
restarting it; otherwise, the cytometer may be damaged.
 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
1-8
Using This Manual
any questions, contact our Customer Service or your local distributor.

 Exercise caution to avoid contact with the sharp sample probe when
performing maintenance.
 To ensure the accuracy of test results, do not mix the new container of
sheath fluid with the old one.
 After sheath container or waste container replacement, check and make
sure all tubes connected with the cap assemblies are not bent or
disconnected.
1-9
Using This Manual
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.
 Only one radio button can be chosen for one setting.
 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 vertexes of polygonal gate must be closed.

 Only gates with the same name, dimension, source and type can be
synchronized.
 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.
 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.
1-10
Using This Manual
 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.
 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.
 If the software register still fails, please Contact Mindray Customer Service
Department or your local distributor.
 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.
 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 user ID cannot be null and up to 12 characters can be entered.
 The note can be null and up to 30 characters can be entered.

 An administrator can reset the password of all users at the operator and
administrator access level.
 The current user logged in cannot be deleted.

 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.
 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
1-11
Using This Manual
reagents as instructed by instructions for use of the reagents.
 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
 When the cytometer is running, or the printing or exporting task is ongoing,

you cannot log out the current user.
 Hibernation mode of the PC is restricted while the software is running. Close
the MRFlow software if you want the PC to enter hibernation mode.
 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.
 Blood samples are single-cell suspensions, thus they do not need to be
processed.
 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.
 To ensure accuracy of analysis results, sample volume of the autoloading
model shall be no less than 300 μL, while sample volume of the manual
1-12
Using This Manual
loading model shall be no less than 100 μL.

6 7
 The recommended cell concentration for analysis is 10 -10 events/mL.
 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.
 25 characters are allowed for sample ID maximally (including prefix).

 If "2-Way LIS/HIS" is selected in the "Setup" - "Communication Setup"
screen, after entering sample ID, the sample and patient information will be
obtained from the LIS/HIS automatically.
 16 tubes can be added at most
 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.
 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.
 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.
 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.
 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.
 If errors like clogging, bubble and abnormal temperature occur during
acquisition, the results may be unreliable, and the errors will be displayed in
1-13
Using This Manual
the error information area; see 9 Troubleshooting for solutions.

 Before the carousels are put to use, they must be labeled and set up
following specified procedures, in order to be identified correctly by the
cytometer.
 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 templates after finishing acquisition, see 6.11 Analyzing

Results.
 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.
 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.
 Tube names of the Mindray panels cannot be edited.
 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.
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.
 After the records are checked, their panels cannot be modified.

 Only samples that have been checked can be transmitted.
 If “Paste tube contents” is selected, the “Acquisition conditions” will not be
applied to acquired tubes.
1-14
Using This Manual
 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.
 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.
 Restore points will be created automatically for samples of “Mindray

templates” and “QC templates” after acquisition.
 Data analysis on software is supported in standby preparation and standby
modes, but acquisition is not allowed.
 Be sure to shut down the cytometer strictly as instructed below.

 Be sure to dilute the CLEANING SOLUTION with distilled water before
performing shutdown procedure, dilution ratio 1:10.
 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.
 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.
 The Product ID shall not be empty and up to 8 digits can be entered.

 It is forbidden to use the keyboard or switch to another window while
scanning the 2D barcode of the control.
 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.
1-15
Using This Manual
 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.
1-16
Using This Manual
1.6 Symbols
You will find the following symbols in this manual:
Symbols Meaning
alerting you to a potentially biohazardous condition.

WARNING alerting you to an operating hazard that can cause
personnel injury.
CAUTION alerting you to a possibility of cytometer damage or
unreliable analysis results.
NOTE alerting you to information that requires your attention.
You may find the following symbols of the cytometer system:
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
WARNING, LASER BEAM
PROTECTIVE CONDUCTOR TERMINAL
ALTERNATING CURRENT
1-17
Using This Manual
SERIAL NUMBER
BATCH CODE
CATALOGUE NUMBER
USE BY
TEMPERATURE LIMIT
CONSULT INSTRUCTIONS FOR USE
IN VITRO DIAGNOSTIC MEDICAL DEVICE
DATE OF MANUFACTURE
MANUFACTURER
THE FOLLOWING DEFINITION OF THE WEEE LABEL

APPLIES TO EU MEMBER STATES ONLY: THE USE
OF THIS SYMBOL INDICATES THAT THIS PRODUCT
SHOULD NOT BE TREATED AS HOUSEHOLD
WASTE. BY ENSURING THAT THIS PRODUCT IS
DISPOSED OF CORRECTLY, YOU WILL HELP
PREVENT BRINGING POTENTIAL NEGATIVE
CONSEQUENCES TO THE ENVIRONMENT AND
HUMAN HEALTH. FOR MORE DETAILED
INFORMATION WITH REGARD TO RETURNING AND
RECYCLING THIS PRODUCT, PLEASE CONSULT
THE DISTRIBUTOR FROM WHOM YOU PURCHASED
THE PRODUCT.
THE DEVICE IS FULLY CONFORMANCE WITH THE
COUNCIL DIRECTIVE CONCERNING IN VITRO
DIAGNOSTIC MEDICAL DEVICES 98/79/EC.
1-18
Using This Manual
AUTHORIZED REPRESENTATIVE IN THE

EUROPEAN COMMUNITY
SENSOR JACK
SHEATH INLET
WASTE OUTLET
1-19
Using This Manual
Figure 1-1 Back of the Cytometer
 Make sure the cytometer is properly grounded.

 To avoid electric shock, disconnect power cord prior to any checking or servicing
operation.
1-20
Using This Manual
Figure 1-2 Front of the Cytometer (Manual Loading)
1-21
Using This Manual
Figure 1-3 Front of the Cytometer (Autoloading)
 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
1-22
Using This Manual
Figure 1-4 Left of the Cytometer (Manual Loading)
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!
1-23
Using This Manual
Figure 1-5 Front of the Cytometer (Inside)
 Note: laser radiation when open this cover or interlock lose efficacy.
1-24
Using This Manual
Figure 1-6 Top of the Cytometer (Inside, Autoloading)
 Note: laser radiation when open this cover. Avoid direct exposure to the laser beam
 Warning: laser radiation. Avoid direct exposure to the laser beam
 Warning: laser radiation. Avoid direct exposure to the laser beam
1-25
Using This Manual
1-26
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.
2-1
Understanding Your Cytometer
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.
The BriCyte E6 provides the following parameters with Mindray panels.

Parameter name Abbreviation
Lymphocyte Absolute Count Lym#
T Lymphocyte % T%
T Helper Lymphocyte % CD4+T%
T Suppressor Lymphocyte % CD8+T%
B Lymphocyte % B%
NK Lymphocyte % NK%
T Lymphocyte Absolute Count T#
+
T Helper Lymphocyte Absolute Count CD4 T#
T Suppressor Lymphocyte Absolute CD8+T#
Count
B Lymphocyte Absolute Count B#
NK Lymphocyte Absolute Count NK#

T Helper/ Suppressor Ratio CD4+T/CD8+T
HLA-B27 HLA-B27
2-2
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
⑤ Autoloader Mixes and loads samples automatically
2-3
2.3.2 Major Modules and Components
Figure 2-1 Front of the cytometer (Manual loading)
1 ---- Indicator 2 ---- Observation window
3 ---- Tube 4 ---- Tube holder
5 ---- Leakage tray
 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.
2-4
 Tube holder
You can use the tube holder to load one sample tube each time.
2-5
Figure 2-2 Front of the cytometer (Autoloading)
1 ---- Tube access door 2 ---- Autoloader
3 ---- Tube 4 ---- Carousel
 Autoloader
The autoloader is located in the front of the cytometer. You can use it to load tubes
automatically.
 Tube access door

The tube access door is located on the top cover of the autoloader. You can use it to insert
or fetch tubes in single tube mode.
2-6
Figure 2-3 Back of the cytometer
1 ---- Filter screen 2 ---- Sensor jack

3 ---- Sheath inlet 4 ---- Waste outlet
5 ---- Network cable jack 6 ---- Power switch
7 ---- Power socket
 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.
2-7
Figure 2-4 Inside front of the cytometer
1 ---- Optical system 2 ---- Flow sensor
3 ---- Sample probe 4 ---- Drive board (1)
2-8
Figure 2-5 Inside left of the cytometer
1 ---- Main control board assembly 2 ---- Power patching board
3 ---- Power source 4 ---- Pressure detection board
5 ---- Drive board (2) 6 ---- Pump &valve drive board
2-9
Figure 2-6 Inside right of the cytometer
1 ---- Waste cistern 2 ---- Waste pump assembly
3 ---- Ceramic pump (1) 4 ---- Ceramic pump (2)
5 ---- Filter(1) 6 ---- Filter(2)
2-10
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
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.
 Control and signal processing system

The control and signal processing system consists of mail control board, Apollo module, laser
control board, indicator board, drive board, pump and valve drive board, pre-amplification
board, power patching board and autoloader patching board. It mainly controls the cytometer
and processes the signals.
 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).
2-11
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.
 Reagent carriage and assembly

The reagent carriage and assembly accommodates reagent containers, and detects reagent
volume by weighing. The assembly consists of reagent carriage, tube cap assembly and
connection lines. A weight sensor is installed inside the reagent carriage so that real-time
reagent volume can be obtained; the cap assembly reaches inside the reagent container to
aspirate sheath and discharge waste; connection lines connect the reagent carriage and
assembly to the cytometer to transmit volume signals and deliver reagents.
 Barcode scanner (Optional)

The barcode scanner is connected with the PC, it reads barcodes. The supported types of
barcode are:
One dimensional barcodes: code39, code128 (including ISBT128), Cross 25 (ITF) and
UPC/EAN/JAN.
Two dimensional barcode: QR code
2-12
2.4 User Interface

Title Functional Login Quick icon
Tab screen
area button area name area
Status area Control panel Client area
 Title area
Displays name of the software.
 Login name
Displays name of the current user.
 Quick icon area
Name Icon Function

About and Register for other Click to enter the About and Register for other
computer computer screen
Logout Click to log out
Shutdown Click to shut down the cytometer
 Tab screen
You will find the following tab screens:
Work Center, QC, Service, Setup and Log
2-13
Click the title to enter the corresponding tab screen.
 Functional button area

Displays the functional buttons available.
 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.
2-14
2.5 Software Operation

Before using MRFlow, make sure you are familiar with the following operations or screen
components.
Move the pointer

Move the pointer displayed on the interface by operating the mouse.
CLICK
Move the pointer to the desired content; left click the mouse then release.
NOTE
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
Right click
Move the pointer to the desired content; right click the mouse then release.
NOTE
DRAG SCROLL BAR

On some screens, the information cannot be fully displayed in one page, then a scroll bar
2-15
(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:
 Click the "arrow button" on the scroll bar.
 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.
View indicating information

The software provides the indicating information to the content displayed (e.g. buttons, titles,
etc.). It will display automatically when the pointer is moved onto the certain area.
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.
2-16
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.
 Arrow buttons of the combo box

Click the button, a pull-down list of the combo box will appear as shown below. The options will
be displayed in the combo list.
Hide the pull-down list by click the arrow button again.
 Arrow button of the date text box

The date text box is shown below.
After clicking the arrow button on the date text box, a date box will pop up.
2-17
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.
Choose the date: click the desired date.

When the date box pops up, you can hide it by pressing the [Esc] on the keyboard.
 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".
2-18
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.
2-19
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.
Date Text box

The date text box is shown below.
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.
Digit Entering Slider Control

The digit entering slide block consists of a text box and a pair of arrows, click the text box or
the arrows, the slide block will appear as follows. Click the text box of the digit entering Slider
control, the slider and a pair of arrows will appear as follows.
Operators may set up the number by the following 3 ways.

1: Enter the number directly into the text box as instructed in the "Text box" section.
2: Drag the slider to the desired number; the number in the text box will change accordingly.
3: Keep on clicking the arrow buttons by the right of the text box until the desired number
displays in the text box.
Form/Table
The form contains several cells and check boxes (sometimes).
Click a cell, it is chosen as shown below:
2-20
Then, you can proceed with the following operations:
 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.
You can proceed with the following operations in the cell:
 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:
 Adjust the position of a column

Click and hold the title of the column, and then drag the column horizontally to the desired
position.
 Adjust the width of a column

Click and hold the boundary line between two columns, then drag the line to adjust the width of
the columns.
 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.
 Select more than one row

If you want to select some contiguous rows:
1. Select the first row.
2. Press and hold ―Shift‖ on the keyboard, and select the last row. All rows between the
2-21
first and last rows will be selected.
If you want to select some discontiguous rows:

1. Select the one row.
2. Press and hold ―Ctrl‖ on the keyboard, and select other row(s).
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
to close the dialog box without performing any operation.
2-22
2.6 Analysis Tools

The software MRFlow provides several analysis tools. The frequently used analysis tools are
graphs, gates and statistics. This section only introduces analysis tools in the "Work Center" -
"Sample " - "Tube" screen.
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
1. Click the dot plot icon in the graph toolbar.
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.
2-23
 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.
The Plot 4 whose data source (GATE) is Lym will be created.
Modify settings
Click the pull-down list of the dimensions to select parameters for axes. See the following
figure.
2-24
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.
2-25
 Allowed ranges of minimum/maximum value

Different display modes represent different allowed ranges for minimum/maximum value, as
shown in below table:
Display ranges of channel dimensions
Display modes Minimum value Maximum value

Linear 0~1048575 0~1048575
Log 1.00~6.02 3.00~6.02
Fixed at 1.00 by
Biexponential 3.00~6.02
default, cannot be set
 Set application rules
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.
Copy plot to the clipboard

Method 1: Right click the plot to be copied, and select "copy plot" from the pop-up menu.
Method 2: Select the plot to be copied, and press [Ctrl] + [C] keys on the keyboard.
2-26
The copied plot can be pasted to Office software.
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.
2-27
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.
Rotate the 3D plot

Click the target 3D plot and rotate it according to the following ways.
Method 1: Press the mouse and drag the plot, it will rotate by the dragging direction.
Method 2: Drag the horizontal rotary slider above the plot, the plot will rotate horizontally; drag
the vertical rotary slider by the right of the plot, the plot will rotate vertically, as shown in the
following figure.
2-28
Click the button to restore the 3D plot to its original state.
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.
2-29
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.
Autopolygon gate: Click the gating button , select from

the pull-down list, and then click on the target position in the plot area, an autopolygon gate will
be created around the distinct population at the target position, as shown in the following
figure.
2-30
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.
Copy gates/ Paste gates/ Overwrite gates

 Copy gate
Right click the gate to be copied and select "Copy gate" from the pop-up menu to finish copy.,
 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
2-31
"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:
Sample gates sync

With the ―Sample gates sync‖ function, you can quickly synchronize all requirement-met gates
of all tubes under the same sample.
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
2-32
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.
 Synchronization of one group of gates

Right click the gate to be used (in the example, polygonal gate P1 of Tube 1), and select
―Sample gates sync‖ from the pop-up menu. The same-named gate in the other plot (in this
case, polygonal gate P1 of Tube 2) will be adjusted to the same shape and position as its
counterpart in the first plot (in this case P1 of Tube 1), while all other gates in the plot remain
unchanged, as shown in below figures:
 Synchronization of all gates in the current group of plots

Right click the blank space in the first plot (in the example plot 1 of Tube 1), and select ―Sample
gates sync‖ from the pop-up menu. All the gates in the plot of other tube(s) (in this case, plot 1
of tube 2) will be adjusted to the same shapes and positions as their counterparts in the first
plot (in the case, plot 1 of Tube 1), as shown in below figures:
2-33
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
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
NOTE
 The population name entered cannot include space or symbols like "()".
 New logic population

Right click the population hierarchy, and select "New logic population" from the pop-up menu,
the following dialog box will display.
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
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
2.7 About and Register for Other Computer
2.7.1 About
Click the button, and select "About" in the pull-down menu to check the version and
configuration information.
2.7.2 Register for other Computer
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
2.8 Reagents, Controls and Calibrators

As the flow cytometer, reagents and controls are components of a system, performance of the
system depends on the combined integrity of all components. You must only use the
Mindray-specified reagents (see Appendix B.2 Reagents), otherwise, the cytometer may not
meet the performance specified in this manual and may provide unreliable results. All
references related to reagents in this manual refer to the reagents specifically formulated for
this flow cytometer.
Each reagent package must be examined before use. Product integrity may be compromised
in packages that have been damaged. Inspect the package for signs of leakage or moisture. If
there is evidence of leakage or improper handling, do not use the reagent.
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
2.8.2 Fluorescence Setup Particles

The fluorescence setup particles are used for auto setup and performance tracking of the
cytometer. Running particles daily monitors the status of the flow cytometer, and ensures its
stability and precision. Store and use the particles as instructed by the instructions for use.
All references related to fluorescence setup particles in this manual refer to the particles
specifically formulated for this cytometer by Mindray. You must buy those particles from
Mindray or Mindray-authorized distributors.
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.
The principles used by this cytometer for measurement are:
 flow cytometry with multi-laser excitation and fluorescent staining technology

 liquid flow measurement technology
3-1
Understanding the System Principles
3.2 Fluidic Principle

The cytometer employs the principle of hydrodynamic focusing to align cells and confine them
one-by-one through, and changes analysis speed by adjusting sample flow rate.
3.2.1 Formation of Sample Flow

Suspension of cells stained by fluorescent dyes is injected into the flow cell fast and steadily by
fluid pressure to form the sample flow. Surrounded with sheath fluid, the cells pass through the
sensing region of the flow cytometer in single file.
Constant vacuum is sustained by the outlet of the flow cell to aspirate waste from the flow cell
and then discharge it.
Figure 3-1 Flow cytometry
3.2.2 Change of Flow Rate

Sample flow rate is changed by alteration of the sampling vacuum in the flow cell, which
depends on the sheath flow rate. The higher the sheath flow rate, the lower the sample flow
rate and the better the single-row layout of cells is. Higher precision will be achieved at Low
flow rate. It is recommended that you use low flow rate for applications that require high
precision, such as DNA content and QC particles analysis.
3-2
Figure 3-2 Principle of flow rate change
3.2.3 Flow Measurement

A liquid flow sensor is connected to the sample probe to measure sample flow rate.
3-3
3.3 Optical Principle
3.3.1 Optical Excitation

The blue (488nm, 43mW Diode Laser) and red (638nm, 55mW Diode Laser) laser beams are
reflected respectively by dichroic mirrors (DM1, DM2), and then focused into an elliptical beam
spot (applicable to particles less than 50μm) on the sample stream by focus lens. See the
following figure.
Figure 3-3 Optical excitation
3.3.2 Optical Detection

The laser beams are focused and kept perpendicular to the sample stream, particles in the
sample that are illuminated produce Forward scatter (FSC), Side scatter (SSC) and other
Fluorescent (FL) signals.
Forward Scatter detection: the forward scatter is collected at angles of 1°to 10.5°to the axis of
the laser beam. the laser beam and forward scatter at angles less than 1°is blocked by the
beam stop (BS) first. After that the scatter passes through the 488/10(nm) filter, which only
allows transmission of scatter light from the 488nm laser, and is then collected by the
photodiode (PD).
Side Scatter and Fluorescence detection: the red and blue beam spot are separated, the
sample stream passes through the blue beam spot first, and then the red; side scatter and
fluorescence are collected to the vertical direction of the laser beam axis. The side scatter is
filtered by the 491(nm) Long Pass filter (LP) and 488/10(nm) Band Pass filter (BP), and then
collected by the photodiode (PD). The FL1~FL6 fluorescence signals are separated and
filtered, and then collected by the corresponding high-sensitivity photomultiple tubes (PMT).
The following section introduces optical principles of the 2-laser, 4-color, 5-color, and 6-color
configurations.
3-4
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.
Figure 3-4 Optical layout of 2-laser, 4-color
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
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.
Moreover, FL3 fluorescence channel can be modified to measure signals of ECD or PI by

replacement of 645LP with 605LP，and 670LP with 620/30BP. See the following figure for the
optical layout.
Figure 3-7 Optical layout of 2-laser, 6-color (ECD/PI)
3-6
3.4 Control and Signal Processing

The control and signal processing system consists of the preamplification unit, main control
unit, drive and monitor unit and the power unit, as shown in the following figure.
Figure 3-8 Structure of the control and signal processing system
3.4.1 Preamplification Unit

Functions of the preamplification unit are photoelectric signal conversion, signal adjustment,
and gain setup. The cytometer uses photodiodes for scatter signal conversion, and
photomultiple tubes for fluorescent signal conversion
3.4.2 Main Control Unit

Functions of the main control unit are: pulse identification and effective particle determination,
and interaction with MRFlow installed on the PC.
3-7
 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.
Figure 3-9 Generation of pulse signals
 Interaction with MRFlow

The main control unit uploads analysis results, system status and error messages to MRFlow,
receives control commands (including analysis control, maintenance, self-test, etc.) from
MRFlow, and implements the commands.
3.4.3 Drive and Monitor Unit

The drive and monitor unit drives the power components of the system (motors, pumps, valves,
etc.), and monitors pressures, flow signals, temperature signals, etc.
3.4.4 Power Unit

The power unit provides analog power, digital power and driving power source for the
electronics via AC/DC and DC/DC conversion.
3-8
4 Installing Your Cytometer
4.1 Introduction
WARNING
your system without the presence of Mindray-authorized personnel.
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
4.2 Installation Requirements

4.2.1 Space Requirements
While installing the cytometer, make sure there is enough space left for service and
maintaining operations, as well as for the cytometer to dissipate heat and for the fluidic tubing
to be properly placed without extrusion. Specific requirements are shown as follows:
 proper height to place the cytometer;
 at least l meter to the left side of the cytometer;
 at least 500mm to the right side of the cytometer;
 at least 600mm above the cytometer;
 at least 250mm behind the 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.
4.2.2 Power Requirements
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
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.
4.2.3 General Environment
Working Environment Storage Environment

Ambient 15℃～32℃ -10℃～50℃
Temperature
Relative Humidity 20%～85% 15%～85%
Atmospheric 70kPa～106kPa 50kPa～106kPa
Pressure
 The environment shall be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.
 It is advisable to evaluate the electromagnetic environment prior to operation of this

cytometer.
 Do not use this cytometer in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
 Do not place the cytometer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
 Do not place the cytometer in direct sunlight or in front of a source of heat or drafts.
 The environment shall be ventilated.
 Do not place the cytometer on a slope.
 Connect only to a properly earth grounded outlet.
 Only use this cytometer indoors.
4-3
4.2.4 Moving and Installing the Cytometer
WARNING
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.
Moving and installation of the cytometer shall be conducted by Mindray-authorized personnel.

Do not move or install your cytometer without the presence of Mindray-authorized personnel.
4-4
4.3 Connecting the Cytometer System

4.3.1 Reagents
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.
your eyes, wash them off with plenty of water and immediately go see a doctor.
Make sure the connection lines of the tubing are insulated.
Figure 4-1 Connecting the reagents
4.3.2 Connecting the Analysis System

Make sure the connections are correct and firm.
4-5
Figure 4-2 Connecting the Analysis System
4-6
4.4 Software Register
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
4.4.1 Local Register

Local register applies to the following scenarios:
1. Physical connection of the PC and flow cytometer has been built up.
2. The PC and the flow cytometer are connected via LAN.
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.
4.4.2 Non-local Register

Non-local register applies to the scenario that the PC is not connected with the flow cytometer.
1. When running the MRFlow for the first time after the installation, the following dialog box
will display.
4-8
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
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
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
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
Click "Setup" to enter the following setup screen.
After modifying setting in each setup screen, you may switch the screen to save the change,
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.
5.2.1 Host Setup

In the "Host Setup" screen, you may set up the following information:
 IP address
 Channel
 Standby
 Absolute count calibration factor (%)
5-2
 Autoloading, view time(sec) after each tube(autoloading model)

 Mix settings (autoloading model)
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.
Autoloading, view time (sec) after each tube (autoloading model)
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.
Absolute count calibration factor(%)
Click the text box to enter the absolute count calibration factor (%) directly, or drag the slider to
5-3
set up the value, the range is 50%~150%.

The absolute count of Lymphocyte Subsets auto algorithm (Mindray Panel) of this cytometer is
calibrated at the factory before shipment. You only need to recalibrate this cytometer if:
 a major component has been changed (flow cell, sample probe, flow sensor);
 you are going to re-use the cytometer after a long-term storage;
 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 )
 Calibration program based on lymphocyte concentration
1. Prepare a normal fresh blood sample with the lymphocyte concentration of

1500~3000 events/uL.
2. Use a calibrated hematology analyzer or other traceable flow cytometer as the

reference device, run the sample for 3 times in a row to get the lymphocyte
concentration (absolute result) of the sample, the mean of the 3 results will be used as
the ―Reference Mean‖.
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:
Current calibratio n factor  Reference mean

New calibratio n factor＝
Measured mean
5. Exit the screen, and click ―Yes‖ in the ―Setting has been modified, save the change?‖
dialog box.
 Calibration program based on BD TruCOUNT Beads
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
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‖
Reference Beads Concentration = Manufacturer- defined value / 500
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
Mix settings (autoloading model)
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.
5.2.2 Graph Parameters

In the "Graph Parameters" screen, you may setup the following information:
 Histogram Smooth
 Show population percentage

 Background of Histogram
 Contour setup
Histogram Smooth
Click the check box to enable or disable smooth display of histograms.
Show population percentage
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
Select a color tag and then click "OK".
Contour setup
Click the "Contour line number" pull-down list to select contour line number.
5.2.3 User Management

In the "User Management" screen, operator and administrator access levels are provided with
different functions.
General User
5-7
 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‖.
2. Enter the required information in the text boxes.
3. Click ―OK‖ to save the change and close the dialog box.
NOTE
Administrator
5-8
 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‖.
2. Enter the required information in the text boxes.
NOTE
 Add a new user
1. Click the ―New‖ button.
5-9
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
 Click ―No‖ not to display.
5. Enter ―Note‖ if needed.
6. Click "OK" to save the change and close the dialog box.
NOTE
 The name cannot be null and up to 20 characters can be entered.

 Edit user information
1. Select a user, and then click ―Edit‖.
5-10
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.
3. Reselect the ―User group‖ if needed.
4. Enable or disable ―Login screen display‖ of the User ID if needed.
NOTE
 The name cannot be null and up to 20 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
 Delete user
Select a user and then click ―Delete‖ to delete it.
NOTE
 The current user logged in cannot be deleted.
5.2.4 Communication Setup

In the "Communication Setup" screen, you may set up the following items for the
communication between the software and LIS/HIS:
 Communication Mode Setup
 Network Setup
 Protocol Setup
 Transmit mode
 Panels setup for LIS

To learn more about Communication, refer to Appendix C Communication.
Communication Mode Setup
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
 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..
 ACK Synchronous Communication

Click the check box to set up ACK synchronous communication conditions.
Transmit Mode
Click the check boxes to enable the "2-Way LIS/HIS" and "Auto transmit after check" functions.
Panels Setup for LIS/HIS
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.
5.2.5 Print Setup

In the "Print Setup" screen, you may set up the following information:
 Print Setup
5-13
 Print & Validation Setup
Print Setup
Click the ―Printer‖ pull-down list to select default printer.

Enter the copies of printed reports in the "Copies" text box (the default setting is "1").
Print & Validation 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:
 Edit template name
 Add new group
 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.
Edit template name
Select the template to be edited, click in its cell to edit the template name.
Add new group
All customized templates are in the "Custom templates" group if there is no custom group, as
5-14
shown in the following figure.
 Add new group

Click the "New group" button, the group name text box will appear at the bottom of the
table, enter the name in the text box.
 Adjusting position
Click and hold the target group, and then drag it horizontally to the desired position.
 Adjusting template group

Click and hold the target template, and then drag it horizontally to the desired group.
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.
5.2.7 Lab Info.

In the "Lab info." screen, you may set up the following information:
 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
them.
Field
Enter field information in the following text boxes.
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.
3. Click the "Open" button to complete logo Setup.
5-16
NOTE
 Maximum pixel of the logo picture allowed is 150*150.
5.2.8 Reagent Setup

In the "Reagent Setup" screen, you may setup the following information:
 HLA-B27 Lot NO.:
 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.
5.2.9 Preference Setup

In the "Preference Setup" screen, you may setup the following information:
 Frequent data type

 Technologist modification permission
 Auto-compensation Settings
Frequent Data Type
Click the radio buttons to set up frequent data type to A, H or A&&H.

When A is selected, signal A of all channels in the plot axis pull-down list are fully expanded,
5-17
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.
Technologist Modification Permission
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
Auto-compensation settings is used for ―Auto_Compensation‖ panel template in the worklist.

To learn more about Auto-compensation, refer to 6.10.3 Auto Compensation (Based on
Single-Stained Tubes).
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
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
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
Switch off the

cytometer and close
MRFlow software
Shutdown
6-1
Operating Your Cytometer
6.2 Initial Checks

Perform the following checks before turning on the cytometer..
WARNING
 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.
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
 Checking the sheath container

Make sure sheath volume is sufficient; replace the sheath container if necessary，refer to
Replacing the Sheath Container.
 Checking the waste container

Make sure the waste container is empty and sterilized before starting up the cytometer every
day.
 Checking tubing and power connections

Check and make sure the sheath and waste tubing are properly connected and not bent.
Check and make sure the power cord of the cytometer is properly plugged into the power
outlet.
 Checking barcode scanner, keyboard, mouse and PC

Check if the power cord of the PC is properly connected to the cytometer.
Check if the power cords of the barcode scanner, keyboard and mouse are properly connected
with the PC.
6-3
6.3 Startup and Login
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.
3. The following login dialog box will display.
4. Enter the correct user ID and password, and then click "OK" to enter the "Work Center"
screen.
6-4
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.
 Hibernation mode of the PC is restricted while the software is running.

Close the MRFlow software if you want the PC to enter hibernation
mode.
6-5
6.4 Daily Quality Control

Before running any samples, perform auto setup and run controls to ensure reliable results of
the cytometer. See Chapter 7 Using the QC Programs for details.
6-6
6.5 Preparing Samples
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.
6.5.1 Applicable Tubes

Specifications of applicable tubes of the flow cytometer are listed in the following table:
Type Outer diameter Length Thickness Applicable models
(mm) (mm) (mm)
12×75 mm 12±0.4 75±2 1±0.15 Autoloading/manual
Tube loading
Centrifugal tube Manual loading
(1.5ml conical 11±0.2 40±2 / (with centrifugal tube
base ) adapter)
6-7

(2.0ml round 11±0.2 40±2 / (with centrifugal tube
bottom) adapter)
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.
6.5.2 Preparing Samples

You should choose the sample processing method based on the sample type and the assay
desired. The typical sample process procedures are introduced as follows:
Preparing Single-cell Suspensions (if needed)
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.
6-8
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.
 To ensure accuracy of analysis results, sample volume of the autoloading

model shall be no less than 300μL, while sample volume of the manual
loading model shall be no less than 100μL.
 The recommended cell concentration for analysis is 106-107 events/mL.
6-9
6.6 Entering Worklist Information

Click "Work Center" - "Worklist" to enter the worklist screen.
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.
There are 2 parts of sample information:
 Basic sample information in the worklist
 Sample and patient information in the ―Sample‖ screen
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.
6.6.1 Basic Sample Information

You may enter basic sample information in the table of the "Worklist" screen.
6-10
 Entering the sample ID
Enter or edit sample ID in the "Sample ID" text box.

The sample ID generation rule is auto increase. If the previous sample ID ends with a digit, the
new sample ID will end with the digit plus 1 by default; if the previous sample ID ends with a
letter or character, the new sample ID will not change.
NOTE
 25 characters are allowed for sample ID maximally (including prefix).

screen, after entering sample ID, the sample and patient information will be
obtained from the LIS/HIS automatically.
 Selecting panel template
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.
 Editing tubes (of customized panel)
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.
 Selecting the tube position (for autoloading model)
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.
6-11
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.
 Entering the NO.
Enter or edit the tube NO. in the "NO." text box.
6.6.2 Extended Sample and Patient Information

The extended sample and patient information can be entered in the "Sample"—"Sample Info."
screen.
6-12
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.
6-13
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
Enter name of the clinician in the "Clinician" text box.
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
Enter the patient name into the ―Name‖ box.
 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
6-14
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
Enter the name of the department into the "Department" field.
 Ward
Enter the name of the ward into the ―Ward‖ field.
 Bed No.
Enter the bed No. into the ―Bed No.‖ field.
 Clinical diagnosis
Enter the clinical diagnosis result into the "Clinical diagnosis" field.
 Doctor in charge
Enter name of the doctor in charge in the "Doctor in charge" field.
After you finish edition of the worklist, switch screen to save the information.
6-15
6.7 Creating Templates

Before running samples, you must define panel templates for the samples. You may edit an
existing template and save as a new one.
6.7.1 Editing Templates

The following groups are included in the ―Panel‖ pull-down list: ―Mindray templates‖, ―QC‖,
―Custom templates‖, ―Recently used‖, ―Auto Compensation‖ and ―Empty‖.
―Mindray templates‖ and ―QC‖ groups allow the software to enable automated algorithms and
realize differentiation and enumeration of the populations.
―Custom templates‖ group include all custom templates saved by users. To edit template
names or delete templates, refer to 5.2.6 Template.
―Recently used‖ group is updated by the software. It is shown on the top of the list for easy
access to templates recently used.
―Auto Compensation‖ is the panel template for auto compensation, based on single stained
tubes. To learn more about Auto-compensation, refer to 6.10.3 Auto Compensation (Based on
Single-Stained Tubes).
Editing Empty template
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.
6-16
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).
5. Click ―Control Panel‖—‖Channels‖ to select desired fluorescence channels (FSC and

SSC are compulsory), set up display mode (linear/log, biexponential) and voltage of
each channel. If the voltage cannot be predetermined, it may be adjusted during
acquisition
6. Click "Control Panel"—"Threshold" to set up threshold channels, values and the

combination mode (OR/AND) . Threshold values can be adjusted from 500 to 1048575.
If the threshold value cannot be predetermined, it may be adjusted during acquisition.
6-17
7. Click "Control Panel"—"Compensation" to set up compensation matrix of the channels,

the input range is 0~200%; compensation values may be adjusted before, during or after
acquisition.
8. (If biexponential display is selected in ―Channels‖) Click "Control

Panel"—"Biexponential" to set up the biexponential display mode. The default setting
method is Auto, the negative range of the channels cannot be modified; to modify the
values, select "Manual" to enable the ―Below Zero‖ fields. The values can be adjusted
from 5 to 1048575.
6-18
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.
Sample Volume after Preparatio n

Dilution Ratio 
Patient Specimen Volume
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.
6-19
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.
Editing Mindray Panels
There are 4 Mindray panels: lymphocyte subsets (T/B/NK-Auto), T lymphocyte subsets

(CD3/8/45/4-Auto), BNK lymphocyte subsets (CD3/16+56/45/19-Auto) and HLA-B27
(HLA-B27-Auto), you may select the one closest to your desired template for editing.
NOTE
only edit the "Abs. Count", "Stop conditions", "Events to Display" in the
 To edit Mindray templates after finishing acquisition, see 6.11 Analyzing

Results.
1. Select a sample from the worklist, and then select the closest Mindray template from the
" Panel" pull-down list, for example "TBNK-Auto".
6-20
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.
3. Select tube T, the following "Sample "—"T" screen will display.
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.

Dilution Ratio 
6-21
Lym gate. The combination mode of the options is "OR", which means recording will be
stopped when either of the conditions is met first..
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.
Editing Custom Templates
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).
6-22
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.
3. Select tube T, the following "Sample—"T" screen will display.
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).

each channel. If the voltage cannot be predetermined, it may be adjusted during
acquisition.
6-23

combination mode (OR/AND). Threshold values can be adjusted from 500 to 1048575. If
the threshold value cannot be predetermined, it may be adjusted during acquisition.

the input range is 0~200%; compensation values may be adjusted before, during or after
acquisition..
8. (If biexponential display is selected in "Channels") Click "Control

6-24
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.

Dilution Ratio 
6-25
about 50μL/min, High: about 100μL/min.)
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.
6.7.2 Saving Template

After editing a template, you may save it or save as a new panel template in the "Panel "
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 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.
6-26
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
6-27
6.8 Running Samples - Manual Loading
 All the samples, controls, reagents, wastes and areas contacted by them are
WARNING
injury.
CAUTION
 Do not reuse disposable products.
NOTE
tube.
and absolute counts, and extra calibration of absolute count and adjustment
6.8.1 Before Running Samples

12x75mm tubes and centrifugal tubes are acceptable to manual loading model，see 6.5.1
Applicable Tubes.
6-28
 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.
6.8.2 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
6-29
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.
6-30
NOTE
 If absolute count is enabled, the "High" or “Mid” flow rate shall be used, and
be inaccurate.
 To edit Mindray templates after acquisition, see 6.11 Analyzing Results.
Running Samples of Custom Panels
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.

each channel. To realize auto adjustment of voltage, see 6.10.1 Auto Adjustment of
Voltage.
6-31

combination mode (OR/AND). Threshold values can be adjusted from 500 to 1048575.

the input range is 0~200%; compensation may be adjusted before, during or after
acquisition. To realize auto adjustment of compensation after acquisition, see 6.10.2
Auto Adjustment of Compensation.
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.
6-32

from 5~1048575.
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.

Dilution Ratio 
6-33
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
be inaccurate.
 To edit custom panel templates after finishing acquisition, see 6.11
Analyzing Results.
6-34
6.9 Running Samples - Auto Loading
 All the samples, controls, reagents, wastes and areas contacted by them are
WARNING
injury.
 Do not try to pull the autoloader door open forcefully when it is locked.
CAUTION
 Do not reuse disposable products.
NOTE
tube.

and absolute counts and extra calibration of absolute count and adjustment
 Before the carousels are put to use, they must be labeld and set up
following specified procedures, in order to be identified correctly by the
cytometer.
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
6-35
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.
6.9.1 Running Samples - Batch Mode

Under the batch mode, the cytometer starts autoloading and acquisition from the selected tube
and searches downwards for tubes to be run in the worklist. Autoloading finishes when there
are no more tubes to be run in the worklist. The tubes must be in the carousel positions
6-36
specified in the worklist.
WARNING
 Each tube must be exactly in the carousel position specified in the worklist
to avoid incorrect results.
Before Running Samples
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.
6-37
6. Close the autoloader door.
Running Samples
 Running Samples of Mindray Panels
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
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.
Sample Volume.
6-39
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
be inaccurate.
 Running Samples of Custom Panels
display.
6-40
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.
Sample Volume.
6. The cytometer will start recording automatically. To adjust cytometer settings, click the
" (acquire)" button and do as follows.

each channel. To realize auto adjustment of voltage, see 6.10.1 Auto Adjustment of
Voltage.
6-41
8. Click "Control Panel"—"Threshold" to set up threshold channels, values and of the


6-42
11. (If biexponential display is selected in " Channels") Click "Control

value, select "Manual" to enable the ―Below Zero‖ fields. range of The values can be
adjusted from 5 to 1048575.
12. To enable absolute count, click ―Control Panel"—" Abs.Count" to select " Enable

Dilution Ratio 
6-43
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
NOTE
be inaccurate.
 To edit custom panel templates after acquisition, see 6.11 Analyzing Results.
6.9.2 Running Samples - Single-tube Mode

Under the single-tube mode, the cytometer only runs the current tube. The tube must be
placed in position 20 of the carousel; the position specified in the worklist is invalid. The
autoloader door is locked; the tube must be placed in the carousel through the tube access
door.
Before Running Samples
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.
3. Close the tube access door.
6-45
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.
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
7. Repeat the procedure above to process additional tubes.
NOTE
be inaccurate.
 Running Samples of Custom Panels
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.
Sample Volume.

each channel. To realize auto adjustment of voltage, see 6.10.1Auto Adjustment of
6-47
Voltage.


6-48

from 5 to 1048575.
10. To enable absolute count, click ―Control Panel"—" Abs.Count" to select " Enable

Dilution Ratio 
6-49
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 .
17. Repeat the procedure above to process additional tubes.
NOTE
be inaccurate.
 To edit custom panel templates after acquisition, see 6.11 Analyzing Results.
6-50
6.10 Auto Adjustment Tools

The MRFlow software provides quick adjustment of voltage and compensation.
6.10.1 Auto Adjustment of Voltage

You may choose a population in the dot plot or density plot, and define the target position it
would be by dragging the cursor; the cytometer will calculate and reset the voltages
automatically; finally the plot will be refreshed to place the population to the target position.
The auto voltage adjustment function may only be available during acquisition.
The procedure of auto voltage adjustment is as follows:
1.
Select the plot to be adjusted (dot plot or density plot), click the ― (Auto tools)‖ button
below to select from the pull-down list, as the following

figure shows.
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.
6-51
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.
6.10.2 Auto Adjustment of Compensation (Based on Plot)

The software can calculate and adjust compensation values automatically based on the
selected plot, and refresh the plot to get the aligned distribution of populations. The auto
compensation adjustment function may only be available after acquisition.
6-52
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.
The procedure of auto compensation adjustment is as follows:
1.
Select the plot to be adjusted (2-color dot plot or density plot), click the ― (Auto tools)‖
button below to select from the pull-down list. The
following figure shows FITC/PE dual-color compensation.
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.
6-53
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.
6-54
6.10.3 Auto Compensation (Based on Single-Stained Tubes)

The software can provide fast and accurate spectral overlap values between FL channels, with
the Auto Compensation feature. ―Auto_Compensation‖ panel template is designed to work with
single-stained controls. These controls can consist of single-stained cells or capture beads. An
unstained control is required as well, in a separate tube or in the same tube as the
single-stained controls.
Before using ―Auto_Compensation‖ panel template, verify the setup options according to your
sample type and required FL parameters. See 5.2.9 Preference Setup - Auto-compensation
Settings.
The following example shows the protocol you choose ―Cells‖ as the sample type and ―A‖ as
the FL parameter (dimension) for a 4-color auto compensation, also with a separate unstained
tube.
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.
6-55
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)
6-56
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.
6-57
6.11 Analyzing Results

After each run, the cytometer will save the result automatically into the sample database. Up to
20,000 sample results can be stored.
In the "Work Center" - "Worklist" screen, you may click "Current Sample‖ or ―Sample Review‖
to browse current samples or all samples in table mode.
In the "Work Center" - "Sample" screen, you may edit graphs and results, and create statistics.
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.
6-58
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
extended, as shown in the following figure.
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
dialog box will pop up.
6-59
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
The following figure shows the buttons of worklist.
 Adding sample
Click the " (add sample)" button, a new sample will be added at the bottom of the table.
 Adding samples (Batch)
Click the " (add samples (Batch))" button to add a batch of samples, using one predefined
panel template in a single step.
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.
6-60
2. (For manual loading model) enter start sample ID, required number of samples, and
select the panel template in the pop-up dialog box.
3. Click "OK" to add required samples.
NOTE
 If the “Auto-increase Carousel ID” check box is disabled, a total of 40 tubes
can be added at most in a batch.
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.
6-61
 Searching for sample
Do as follows to search for a sample:
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
The export FCS procedure is as follows:
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.
6-62
 Import FCS
The import FCS procedure is as follows:
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.
6-63
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.
6-64
NOTE
 The templates in "Empty", “Mindray templates” and “QC templates” groups
 After acquisition, the modified Mindray template cannot be saved as

Mindray template.
 Delete
1. Select the sample or tube to be deleted, and click the " (delete)" button in the toolbar,
2. Click "Yes" to delete the sample or tube.
 Check/Cancel (for administrators only)
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
check)"; the "Status" column of the sample record will be deselected.
NOTE
 After the records are checked, their panels cannot be modified.
6-65
 Communication
1. Select the sample(s) to be transmitted in the worklist area.
2. Click the " (Comm.)" button.
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.
Functions of Right Click (Copy/Sync)
 Sample tubes sync

You can apply parts of or the whole contents (including the acquisition conditions,
compensation and graph analysis) of one tube to other tubes of the same sample.
Right click the tube to be used, and select ―Sample tubes sync‖ from the pop –up menu. The
―Sample tubes sync‖ dialog box will pop up, as shown below:
6-66
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.
 Copy/Paste tube contents

You may copy and paste parts of or the whole tube contents (acquisition conditions,
compensation and graph analysis) to other tubes (of the same or a different sample).
6-67
Copy tube contents

Right click the tube to be copied, and select ―Copy tube contents‖ from the pop-up menu as
shown in below figure. All the tube contents (including acquisition conditions, compensation
and graph analysis) are copied.
Customize tube contents to be copied

Right click the tube to be copied, and select ―Customize tube contents to be copied‖ from the
pop-up menu, the ―Customize tube contents to be copied‖ dialog box will display as shown
below.
6-68
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.
Paste tube contents

Select and right click the tube(s) (of the same or a different sample) you want to paste the
contents to, and select ―Paste tube contents‖ on the pop-up menu, as shown in below figure:
A note will be displayed as shown below.

The displayed note varies in accordance with the your most recent ―copy‖ action. If you have
selected ―Copy tube content‖, the note will be: About to paste the following contents;
Acquisition conditions, Compensation, Graph analysis.‖; if you have selected ―Customize tube
contents to be copied‖, the note will list your selected copy options accordingly.
Check if the contents to be pasted are right and click ―OK‖.
6-69
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.
 Copy/Paste sample contents

You can copy and paste all information of a certain sample (Tube, Report, Acquisition
conditions, Compensation and Graph analysis) to other samples.
Copy sample contents

Right click the sample to be copied, and select ―Copy sample contents‖ from the pop-up menu
(as shown below) to copy all the sample contents (including Tube, Report, Acquisition
conditions, Compensation and Graph analysis).
Paste sample contents

A note is displayed as below: Select and right click the sample(s) to which the contents will be
pasted and select ―Paste sample contents‖ from the pop-up menu (as shown
below).
A note is displayed as below:
6-70
Click ―OK‖ to confirm the pasting.
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.
6.11.2 Sample Analysis

Select a sample in the worklist, and click "Sample info.", "Tube" or "Report" tab in the "Sample"
screen to go to the corresponding pages.
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.
6-71
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
6-72
populations will be generated automatically.
See 2.6 Analysis Tools for details.
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.
6-73
2. Select directory and then enter the file name.
3. Click the "Save" button, the report will be saved as a PDF file.
 Print
Click the " (print)" button in the toolbar to print report.
 Add/delete page
Click the " (add page)" button to add a page; click the " (delete page)" button to delete
specified page.
 Insert Lab Info.
Click the " (insert lab info.)" button in the toolbar to insert the predefined lab info. field
and the Logo ("Setup" - "Lab Info.").
 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,
6-74
underline, font color, background color, etc.
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.
5. Use the [Delete] in the keyboard to delete the line.
 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.
 Activate graph window
1. Double click a graph in the report to activate and enlarge the graph window, as shown
in below figure:
6-75
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.
6-76
4. The overlay can be dragged, zoomed or deleted.
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.
 Insert parameter results
1. Click the " (insert parameter results)" button, the following dialog box will display.
The parameters displayed are determined by the panel.
6-77
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.
6-78
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".
6-79
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.
Creating Restore point
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.
 Creating Restore point
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.
 Restoring to Restore point
Click the " (Creating Restore point)" button on the upper right of the ‖Sample‖ - ―Tube‖
screen, and the following dialog box will pop up.
6-80
Click ―OK‖ to restore to the ―Sample‖ screen when the restore point was created.
Flags with Mindray panels
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
6-81
Lymphocyte count in tube BNK does not meet

stop requirement
Check tube T lymphocyte gate
Check tube BNK lymphocyte gate
Check tube T CD3/CD4 gate
Check tube T CD3/CD8 gate
Check tube BNK CD3/CD19 gate
Check tube BNK CD3/ CD16+56 gate
Notes The CD3% deviation *** between T detection and
BNK detection
The deviation *** between CD4%+CD8% and
CD3%
Sum of percentages of T, B and NK cells is ***
HLA-B27-Auto Flags Check lymphocyte gate of ISOtype control tube
Lymphocyte count in ISOtype tube does not meet
stop requirement
Lymphocyte count in B27 tube does not meet stop
requirement
Check the quadrant gate
Check the order of ISOtype tube and tube B27
Check if correct particles were used
T Lymphocyte Subsets Flags Lymphocyte count does not meet stop
（CD3/8/45/4-Auto） requirement
Check lymphocyte gate
Check CD3/CD4 gate
Check CD3/CD8 gate
Notes The deviation *** between CD4%+CD8% and
CD3%
BNK Lymphocyte Subsets Flags Lymphocyte count does not meet stop
（CD3/16+56/45/19-Auto） requirement
Check lymphocyte gate
Check CD3/CD19 gate
Check CD3/CD16+56 gate
Notes Sum of percentages of T, B and NK cells is ***
6-82
6.11.3 Backup and Restoration
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,
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.
6-83
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.
6-84
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.
6-85
6.13 Shutdown
WARNING
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.
 Shut down the cytometer (manual loading)
1. Click the " (shutdown)" button in the quick icon area of the software screen, the
following dialog box will display.
2. Click ―Yes‖, the following dialog box will display.
6-86
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
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.
7. Empty the waste container and dispose of the waste properly.
 Shut down the cytometer (autoloading)
1. Click the " (shutdown)" button in the quick icon area of the software screen, the
6-87
following dialog box will display.
2. Click ―Yes‖, the following dialog box will display.
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
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.
5. Empty the waste container and dispose of the waste properly.
 Exit the MRFlow software
Click the " " button on the upper right of the software screen to close the MRFlow window.
6-88
 Close the external computer
1. Close the external computer according to the shutdown procedures of the operation
system.
2. Turn off the display.
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.
6-89
6-90
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.
7-1
Using the QC Programs
7.2 Auto Setup

Click "QC" to go to the QC screen.
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
You can set up the information using any of the following ways:
 Scanning the 2D barcode of the particles
 Read from the information storage medium

 Manual entry
 Read preset values
Scanning the 2D barcode of the particles
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.
7-3
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.
7-4
Read from the information storage medium
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.
7-5
Read preset values
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.
7.2.2 Auto setup
WARNING
injury.
doctor.
7-6
CAUTION
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
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
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.
7.2.3 Auto setup L-J Graph

Click "QC" - "Auto setup graph" to go to the "Auto setup graph" screen.
The left of the screen shows history auto setup graphs in the form of Levey-Jennings curves,
while the right displays the auto setup report.
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.
 Viewing the Auto setup L-J graph

Drag the scroll bar on the right of the graph to browse graphs of the parameters. Drag the
scroll bar under the graph horizontally to browse all the Auto setup results.
Click a point in the L-J graph to check the corresponding Auto setup result. The green vertical
line is used to identify the points of the same analysis, all of which are displayed on the line
7-9
when you select one of them.
 Printing the Auto setup L-J graph

Click the "Print" button to print the current L-J graphs of all parameters.
NOTE
printed.
7-10
7.3 Parameter QC
7.3.1 Control Information

Before run controls, you need to set up the control information for the batch at the screen
below:
You can set up the control information using any of the following ways:
 Manual entry
 Read preset values
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
entered. You can enter characters, numbers, letters and special

characters.
2. In the "Target" area, set up the parameter targets and the allowable limits.
3. The entry will be saved once it is completed.
Read preset values
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
7.3.2 QC Analysis
WARNING
injury.
doctor.
CAUTION
7-13
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.
3. Click "Work Center" to switch to the "Work Center" screen.

4. Click the " (Add Sample)" button at the "WorkList" screen, and a new item will be
added at the end of the worklist.
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
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
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.
1—The QC report of points along the green vertical line

2—The tested values of points along the green vertical line
3—The line connecting all QC points of the same parameter to show the trend. The QC points
in each graph are displayed from left to right according to the sequence from the earliest to the
latest. A blue QC point indicates the value is within the limit; a red QC point indicates the value
is out of the limit.
4—The green vertical line is used to identify the QC points of the same analysis, all of which
are displayed on the line when you select one of them.
5—New batch of control which is marked in different color in the graph.
 Viewing the QC graph

Drag the scroll bar on the right of the graph to browse graphs of the parameters. Drag the
scroll bar under the graph horizontally to browse all the QC results.
Click a QC point in the QC graph to check the corresponding QC result. The green vertical line
is used to identify the QC points of the same analysis, all of which are displayed on the line
when you select one of them.
 Printing the QC graph

Click the "Print" button to print the current QC graphs of all QC parameters.
7-15
NOTE
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.
 All the cytometer components and surfaces are potentially infectious, so

take proper protective measures for operation and maintenance.
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
8.2 Reagent Management
WARNING
doctor.
 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
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
8.3 Maintenance
Click "Service" - "Maintenance" to go to the "Maintenance" screen.
8.3.1 When to Maintain

Procedure When Why Frequency
De-gas Flow  Abnormal population distribution To removes bubbles As needed
Cell from the flow cell
in plot
 High background noise
 Poor CVs in QC run
De-gas Fluidics  Scattered populations in plot To removes bubbles As needed

from fluidic tubing
 Poor CVs in QC run
Clean Flow Cell  Poor optical signal To decontaminate As needed

the flow cell
 Scattered populations in plot

 Running a great amount of
samples on the day
 Flow sensor abnormal is reported
Fluidics  Abnormal population distribution To clean and reset Every

Initialization in plot the whole fluidics week
 Sheath fluid running out, and lead

to bubbles in tubing
 After connecting/disconnecting
tubes or replacing related parts
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
Prime Sheath  After installing a new container of To make the filter As needed
Filter sheath fluid because of sheath fluid fully filled with
contaminated or bubbles in fluidics sheath fluid
 After replacing the sheath filter
Prime Bubble After replacing the bubble filter To make the filter As needed
Filter fully filled with
sheath fluid
8.3.2 Tools Required for Maintenance

Tools to be Prepared by User
Item Applicable Maintenance
CLEANING SOLUTION Cleaning Flow Cell
Cotton swabs Cleaning Probe wipe and Photocoupler
Clean gauze Cleaning Sample Probe and Leakage tray
8.3.3 De-gas
The operator can perform the following de-gassing operations:
 De-gas Flow Cell
 De-gas Fluidics
De-gas the flow cell as instructed below:

1. Click the "De-gas Flow Cell" button to start, and the progress bar below pops up.
2. After the de-gassing is finished, the progress bar disappears. Repeat the steps if needed.
De-gas the fluidics as instructed below:

1. Click the "De-gas Fluidics" button to start, and the progress bar below pops up.
8-5
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:
 Clean Flow Cell
 Fluidics Initialization
Clean Flow Cell

Cleaning the flow cell as instructed below:
1. Click the "Clean Flow Cell" button, and the dialog box below pops up.
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
8.3.5 Unclogging
The operator can perform the following unclogging operations:
 Unclog Flow Cell
 Unclog Sampling Channel
Unclog the flow cell as instructed below:

1. Click the "Unclog Flow Cell" button to start unclogging the flow cell, and the progress bar
below pops up.
2. After the unclogging is finished, the progress bar disappears. Repeat the steps if needed.
Unclog the sampling channel as instructed below:

1. Click the "Unclog Sampling Channel" button to start unclogging the flow cell, and the
progress bar below pops up.
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:
 Prime Sheath Filter
 Prime Bubble Filter
Prime the sheath filter as instructed below:

1. Click the "Prime Sheath Filter" button to start priming, and the progress bar below pops
up.
8-7
2. After the priming is finished, the progress bar disappears. Repeat the steps if needed.
Prime the bubble filter as instructed below:

1. Click the "Prime Bubble Filter" button to start priming, and the progress bar below pops
up.
2. After the priming is finished, the progress bar disappears. Repeat the steps if needed.
8-8
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
 Photocoupler and switch
8-9
8.4.1 Fluidics
You can check the following fluidics status parameters:
 Waste cistern pressure
 Flow cell pressure
 Sample flow
 Sheath volume
8-10
 Waste volume
8.4.2 Red laser

You can check the following red laser status parameters:
 Temperature
 Current
 Power
8.4.3 Blue laser

You can check the following blue laser status parameters:
 Temperature
 Current
 Power
8.4.4 Other temperatures

You can check the following temperature status parameters:
 Optical system temperature
 Cytometer operating temperature
8.4.5 Circuit system

You can check the following circuit system status parameters:
 Power 24V of drive board 1
 Digital 5V of drive board 1
 Power 24V of drive board 2

 Digital 5V of drive board 1
 Analog 9V of laser board
 Power 12V of laser board
 Analog 5V of laser board

 Analog 12V of main control board
 Analog -12V of main control board

 Analog 5V of main control board
 Digital 12V of main control board

 Digital 5V of main control board
8-11
8.4.6 Photocoupler and switch

You can check the following photocoupler and switch status parameter:
 Sheath ceramic pump zero photocoupler
 Waste ceramic pump zero photocoupler

 Loading motor zero photocoupler (down)
 Loading motor limit photocoupler (up)

 Probe wipe motor zero photocoupler (down)
 Probe wipe motor limit photocoupler (up)
 Waste cistern floater
 Optical cover photocoupler
 Carousel zero photocoupler

 Carousel counting photocoupler
 Carousel detecting photocoupler
 Tube detecting photocoupler

 Autoloader door switch
8-12
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
 Self-test of moving components
 Valve Self-Test
 Self-test of optical system
 Self-test of fluidics system
8.5.1 Self-test of indicators
Perform the self-test as instructed below:

1. Click the "Start self-test" button, the test starts, and the progress bar below pops up.
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
8.5.2 Self-test of moving components
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.
successful.
NOTE
“OK". If the result is still abnormal after you tried several times, please
Perform the fan self-test as instructed below:

1. Click the corresponding button to start the self-test, the test starts, and the progress bar
below pops up.
2. The status bar on bottom left of the screen shows "Please check if the fan can turn on/off
as normal".
3. Check if the fan of the laser turns on/off properly.
successful.
Run the self-test of waste pump switch P2/P3 as instructed below:

8-14
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.
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
8.5.3 Valve Self-test

The valve self-test screen is shown as below:
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.
8.5.4 Self-test of optical system
Perform the optical system self-test of as instructed below:

pops up.
successful.
NOTE
8-16
8.5.5 Self-test of fluidics system
Run the self-test of flow sensor, flow cell pressure sensor, waste cistern pressure sensor as
instructed below:
pops up.
successful. The self-test result is displayed in the field after the corresponding item.
Run the self-test of the bubble filter as instructed below:

1. Click the button of the item you want to test, the test starts, and the dialog box and
progress bar below pop up.
8-17
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".
successful. The self-test result is displayed in the field after the corresponding item.
Run the self-test of the waste cistern floater as instructed below:

1. Click the corresponding button to start the self-test, the test starts, and the progress bar
below pops up.
successful.
Run the self-test of flow cell tube tightness as instructed below:

1. Click the button of the item you want to test, the test starts, and the dialog box and
progress bar below pop up.
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
shows the self-test is successful. The self-test result is displayed in the field after the
corresponding item.
NOTE
8-19
8.6 How to Replace

8.6.1 When to Replace
Procedure When Frequency

Replacing the sheath Sheath fluid insufficient/running As needed
container out/expired/contaminated
Replacing the waste Waste container is full Everyday or as
container needed
Replacing the filters Filter service life ends Every 6 months or
Frequent alarms, and filter serf-test failure as needed
for many times
8.6.2 How to Replace
 Samples, controls, calibrators and waste are potentially infectious. Wear

proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.
WARNING
 The blood sample tainted on the sample probe is potentially bio-hazardous.

Exercise caution to avoid direct contact with the probe.
doctor.。
 When replacing the waste container, take out the tube from the waste
container only when the indicator of the cytometer is static, in order to
prevent from waste blowout.
8-20
CAUTION
 After sheath container or waste container replacement, check and make
sure all tubes connected with the cap assemblies are not bent or
disconnected.
Replacing the Sheath Container

Replace the sheath container as instructed below:
1. Take the sheath container to be replaced down from the reagent carriage, and place it
aside.
2. Place a new container of sheath in the carriage, and uncap it.
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.
Replacing the Waste Container

Replace the waste container as instructed below:
1. Take the waste container to be replaced down from the reagent carriage, and place it
aside.
2. Place an empty waste container in the carriage, and uncap it.
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.
Replacing the Filter

After the filter is used for a long time, the performance of the filter membrane may
compromise, which affect the performance of the cytometer. It is recommended to replace the
filter every 6 months or when the filter self-test fails for many times according to the following
procedure.
1. Power off the cytometer first. If the sheath filter is to be replaced, take off the sheath
container from the reagent carriage and place it lower than the cytometer to avoid sheath
backflow when disassembling the sheath filter.
8-21
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
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
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.
8.7.1 Viewing Logs

Selecting the log type
Click the following tab to display different type of logs: "All logs", "Other logs", "Parameter
modification", "Error info.", or "Sequence running".
Defining the date range
Enter or select the starting and ending dates in the fields above the log list to define a desired
date range of logs.
Selecting the source of logs
Select the desired source of logs from the pull-down list, e.g. MRFlow.
8-24
8.7.2 Exporting Logs

1. Click the "Export" button, and the dialog box below pops up.
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
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
9.2 Error Information

During the operation, if error(s) is detected, the software will display the corresponding error
message, both the indicator of the software and that of the cytometer are flickering red, the
cytometer beeps as well.
When there is an error, click the status area of the screen, the beep stops, and a dialog box
pops up, providing the error name and troubleshooting information. The errors are displayed in
order of the error occurrence time.
You can click the error name in the dialog box to select (highlight) it and check the
corresponding troubleshooting information in the ―Help‖ list under the dialog box. The
troubleshooting information of the first error will display (default). Follow the instructions in
the dialog box to remove the error(s).
The pop-up dialog box is shown below.
Figure 9-1 "System info." dialog box
The dialog box provides the following functions:
 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
 Closing the "System info." dialog box

Click the "Close" button to close the "System info." dialog box, but the status area will still
display the error message. You can click the status area again to open the "System info."
dialog box.
9-3
Troubleshooting
Error info. Help info.

1. The threshold is too low. Reset the threshold and
startacquisition again;
2. Sample concentration is too high. Dilute the sample and start
10901 acquisition again;
Sample processing speed 3. Reduce sample flow speed and start acquisition again;
is too high 4. Check if the network connection between the cytometer and
the PC is proper;
5. If the error still exists, contact our Customer Service
Department.
1. Run auto setup on the QC screen;
11001
Cytometer QC expired
Department.
1. Please re-prepare the sample (refer to the Operator's Manual
11101 for the procedure), and start acquisition again;
Cytometer QC failed 2. If the error still exists, contact our Customer Service
Department.
1. Click "Remove" and then try again;
100901 2. Restart the cytometer;
Setting FSC voltage failed 3. If the error still exists, contact our Customer Service
Department.
Communication is 2. If the error still exists, contact our Customer Service
abnormal Department.
301001
2. Restart the cytometer;
Communication is
abnormal
Department.
301101
Communication is
abnormal
Department.
302001
Communication is
abnormal
Department.
1010101 1. Click "Remove" and then try again;
9-4
Troubleshooting
Sheath aspiration is 2. If the error still exists, contact our Customer Service
Waste discharge is 2. If the error still exists, contact our Customer Service
1030101
Loading action is abnormal
Department.
1030201
Department.
Probe wipe action is 2. If the error still exists, contact our Customer Service
Carousel action is 2. If the error still exists, contact our Customer Service
Sheath aspiration is 2. If the error still exists, contact our Customer Service
Waste discharge is 2. If the error still exists, contact our Customer Service
2030101
Department.
2050101 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
9-5
Troubleshooting
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
Optical box is open
Department.
1. Perform "Maintenance-Prime Sheath Filter", click "Remove"
2110101
and then try again;
Waste discharge is
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
abnormal
Department.
2130101
Blue laser temperature is
abnormal
Department.
2160101
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;
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;
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
2. Perform "Maintenance-Unclog Flow Cell" for 1~3 times, click

Department.
Sample aspiration is 2. If the error still exists, contact our Customer Service
Waste cistern pressure is 2. If the error still exists, contact our Customer Service
Flow cell pressure is 2. If the error still exists, contact our Customer Service
1. Make sure there are no foreign matters on the reagent
3040101
carriage, click "Remove" and then try again;
Reagent carriage is
abnormal
Department.
1. Replace the sheath, click "Remove" and then try again;
3040501
Insufficient sheath
Department.
1. Make sure there are no foreign matters on the reagent
3060101
carriage, click "Remove" and then try again;
Reagent carriage is
abnormal
Department.
1. Empty the waste container, click "Remove" and then try
3060401 again;
Waste container is full 2. If the error still exists, contact our Customer Service
Department.
Red laser temperature 2. If the error still exists, contact our Customer Service
sensor is abnormal Department.
3070401
Red laser temperature is
too high
Department.
3070501 1. Make sure the working temperature of the cytometer is within
Red laser temperature is the range 15~32℃, click "Remove" and then try again;
too low 2. If the error still exists, contact our Customer Service
9-7
Troubleshooting
Department.
Blue laser temperature 2. If the error still exists, contact our Customer Service
sensor is abnormal Department.
3080401
too high
Department.
3080501
too low
Department.
3090101
Ambient temperature
sensor is abnormal
Department.
Optical temperature sensor 2. If the error still exists, contact our Customer Service
is abnormal Department.
3130401
Blue laser power is too high
Department.
3130501
Blue laser power is too low
Department.
3140401
Red laser power is too high
Department.
3140501
Red laser power is too low
Department.
Drive board voltage is 2. If the error still exists, contact our Customer Service
9-8
Troubleshooting
1. Shutdown procedure not finished as normal, remove other
8010101
errors first and click "Remove";
Startup procedure not
completed
Department.
8010201
errors first and click "Remove";
completed
Department.
1. Startup after Pack-up procedure is skipped, click "Remove"
8010301
and then try again;
completed
Department.
Startup procedure not 2. If the error still exists, contact our Customer Service
completed Department.
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.
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
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
Workflow is interrupted by
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
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;
Department.
9010601 first, and then perform self-test again;
Red laser self-testing failed 2. If the error still exists, contact our Customer Service
Department.
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.
9010901
first, and then perform warm-up system self-test again;
Warm-up system
self-testing failed
Department.
9-11
Troubleshooting
9.3 Other Errors
Error Description Possible Reason Recommended Solution

Unable to start up the Power cord not 1. Connect the power cord.
cytometer connected 2. If the error still exists, contact
our Customer Service
Department.
Unable to connect the PC to Network cable between Re-connect the network cable
the cytometer the cytometer and PC
not connected
Communication error Restart the software and the
between the PC and the cytometer
cytometer
The firewall installed by 1. Contact the network
the operator administrator to open the port
for the flow cytometer in the
firewall.
2. If the error still exists, contact
Department.
Warm-up cannot be Improper room 1. Adjust the room temperature to
completed temperature ensure it meets the working
temperature requirement of the
cytometer
Department.
Unable to read the barcode Barcode scanner window Clean the barcode scanner
not clean window
Barcode label not clear Try scanning with a qualified
or wrinkled barcode label, or enter the data
manually
Barcode symbology not Change to the symbologies
supported consistent with the barcode
Frequent clogs in sample Large granule or foreign Filter and rerun the sample
probe or flow cell body in the sample
Residue in sample probe Clean the flow cell, and unclog the
or flow cell sampling channel
Filter failure or inefficient 1. Replace the filter

9-12
Troubleshooting
Department.
Backflow into the tube Flow sensor is abnormal 1. Restart the cytometer, and then
run the "Clean Flow Cell"
procedure
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
Department.
Unable to open the Not switched to Switch to batch loading model
autoloader door batchloading model
Autoloader error 1. Restart the cytometer
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
Bubbles in tubing Run "De-gas Fluidics"

Divergent particle groups in Flow cell not clean Run the "Clean Flow Cell"
plot procedure
Abnormal distribution in plot Bubbles in flow cell Run "De-gas Flow Cell"
A great amount of bubble Run "Fluidics Initialization"
in fluidics
Unqualified CV result in QC High flow rate Reduce the flow rate to middle or
run low
Bubbles in flow cell Run "De-gas Flow Cell"
Bubbles in filter or filter Prime or replace the filter
damaged
Poor or invisible optical Improper voltage or Increase the voltage or reduce the
signals in plot threshold threshold
Optical system is Contact our Customer Service
abnormal or Department
contaminated
FL4, FL6 signal weak while Delay time incorrect Run auto QC delay time
other fluorescence signals calibration again
are normal
Software error, tube cannot Software error 1. Restart the cytometer and the
descend software
Department.
Cytometer not responding to Communication error 1. Restart the cytometer and the
software command between the software software
and the cytometer 2. If the error still exists, contact
Department.
Absolute count result Absolute count Set correct absolute count
incorrect calibration factor calibration factor
incorrect
Dilution ratio incorrect Set correct dilution ratio
Flow sensor error Contact our Customer Service
Department
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
Reagent carriage and assembly, 2-12

Register, 2-38, 4-7
T
Templates
S Creating Templates, 6-16
Template Management, 5-14
Setup, 5-2 Troubleshooting, 9-1
Shutdown, 6-86
Standby, 6-85
Startup, 6-4
U
Symbols, 1-17
User Interface, 2-13
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.3 Applicable Tubes

Type External Length (mm) Wall Thickness Applicable models
Diameter (mm)
(mm)
12×75 mm Tube 12±0.4 75±2 1±0.15 Autoloading/Manual
loading
(with centrifugal tube
(1.5mL conical 11±0.2 40±2 /
adapter)
base)
(with centrifugal tube
(2.0mL round 11±0.2 40±2 /
adapter)
bottom)
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.4.2 Optical Filters
Optical Channel Specification

Filter Type
(nm)
Forward scatter FSC Bandpass filter (BP) 488±5
Side scatter SSC Bandpass filter (BP) 488±5
Fluorescence channel 1 FL1 Bandpass filter (BP) 530±15
Fluorescence channel 3 FL3 Long pass filter (LP) 670
B.5 Parameters
Parameter name Abbreviation

Lymphocyte Absolute Count Lym#
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
B Lymphocyte Absolute Count B#

NK Lymphocyte Absolute Count NK#
T Helper/ Suppressor Ratio CD4+T/CD8+T
HLA-B27 HLA-B27
B.6 Digital Processing Ability

Digital processing ability: 20 bit
B.7 Minimum Sample Volume

Minimum sample volume: 100µL
B.8 Throughput of Autoloading

Throughput of autoloading: 90 tests/h.
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%;
Resolution of Forward Performance optimized for /

and side scatter resolving erythrocytes and
platelets in peripheral blood.
Performance optimized for
resolving lymphocytes,
monocytes, and granulocytes
of leukocytes.
Carryover ≤0.1% Use Thermo Duke 4K-10
particles
Instrument Stability When the ambient Use Spherotech URFP -30-2
temperature is kept within particles
5.0% of the set temperature,
the variation of the
fluorescence intensity and
FSC intensity is ≤10.0%
within 8 hours.
Maximum Acquisition 16,000 events/s /
Rate
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
Temperature 15℃-32℃ -10℃-50℃

Relative Humidity 20%-85% 15%-85%
Atmospheric pressure 70kPa-106kPa 50kPa-106kPa
B-4
Appendices
B.11 Dimension and Weight
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.13 Power supply

Parameter Requirement
Power supply 100V-240V～ , 50Hz/60Hz

Voltage fluctuation range ±10%
Power 500 VA
B.14 Contraindication
None
B-5
Appendices
B.15 EMC Description

 Do not use this device in close proximity to sources of strong electromagnetic
radiation (e.g. unshielded intentional RF sources), as these may interfere with the
proper operation.
 This equipment complies with the emission and immunity requirements of the EN
61326-1:2006 and EN 61326-2-6:2006.
 This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
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.16 Safety Classification

Parameter Description
Overvoltage type Category Ⅱ

Pollution degree 2
Work type Continuous
Degree of IP(Ingress Protection) Common device, IPX0(No protection against liquids)
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
Figure 1 Sample analysis workflow in 1-way communication mode
2-Way Communication Mode
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.
Sample Send to Technician Analysis Sample

(collected at Laboratory
(Sign for receival) Instrument identification
sample collection
center)
Searching
request Sample
(run on the
Send results WorkList instrument)
to HIS
HIS System
Yes Test
Checked? LIS System results
Test Report Check or other

No
Print meausres
Figure 2 Sample analysis workflow in 2-way communication mode

*Note: dotted line means the operation is optional. Similarly hereinafter
C.1.2 Key Scenarios

Scenario1: MRFlow Worklist Request (Request Mode)
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)
Send test Analysis

results to Instrument
LIS (Sample Analysis)
Figure 3 Worklist processing workflow in request mode

Scenario analysis:
Generally speaking, MRFlow needs to be able to read barcodes in this scenario, and then
send worklist request to the external system based on the barcode information. A worklist
request can also be sent based on other information, e.g. sample position information, logic
order of the sample analysis. The external system usually saves some of the worklists in buffer
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:
1） Send the request again.
2） Enter the worklist information manually.

Scenario2: Entering Worklist Information Manually in MRFlow (Manual Mode)
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:
HIS/LIS Print Paper

System Test
Order
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)
Figure 4 Worklist processing workflow in manual mode

Scenario analysis:
This scenario equals to 1-way LIS, where MRFlow completes all works about the worklist
when the external system does not send any message about the worklist to it. In this case, the
laboratory technician has to enter the worklist manually since there is no external system to
rely on.
This scenario is a 1-way communication scenario for hospital which has no LIS system or its
LIS system does not support 2-way communication.
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.
2） Wait for the operator to enter the worklist information manually.
C.1.3 Supported Functions

1） Support connecting instrument, MRFlow, and LIS through relay devices (e.g. HUB,
exchanger, etc.);
2） Support HL7 communication protocol;
3） Support ASTM communication protocol;
4） Support 1-way and 2-way LIS/HIS communication;
5） Support network communication;
6） Support connecting to LIS as either client or server;
7） Support communication after check;
8） Support auto transmit after check.
9） Support previous versions of the communication protocol: both the old version and
new version are applicable after update.
C.1.4 Communication Settings

1） Provide the option of setting MRFlow as the server. If it is not selected, MRFlow will
serve as the client.
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)
C.1.5 Definitions of Transmitted Contents

The following example descripts transmitted contents of HL7.
Analysis Result Type
The OBR-4 (Universal Serview ID) field of HL7 is used to identify the type of the analysis result.
See the following table.
Table 1 Analysis Result Types

Data Code (ID) Name EncodeSys
Analysis Result 00001 Automated Count 99MRC
Patient Information Definition
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.
Table 2 PID Field Definitions
Field/Delimiter Data Description Example

Name Type
Patient CX Used as patient ID in the sample analysis 7393670^^^^MR
Identifier List
result messages, in the form of
"MR"Number^^^^MR‖.
Used as batch No. of control in QC messages.
Patient Name XPN Patient name (consists of FirstName and Liu Jia
LastName), in the form of
"LastName^FirstName"
Date/Time of TS Used as time of birth in sample information 19950804000000
Birth
messages.
In the form of YYYY[MM[DD[HH[MM[SS]]]]].
Used as expiration date of the control in Q
C messages.
Sex IS Gender, string. Female
C-5
Table 3 PV1 Field Definitions
Field/Delimiter Name Data Type Description Example

Patient Class IS Patient type, string, content not Outpatient
defined.
Assigned Patient PL Patient location information, in the Internal
Location form of "Department^ ^ Bed No." Medicine
Financial Class FC Payer, string, content not defined. Patient
Sample Information Definition
The OBR (Observation Request) segment contains the test report information.
See the following table for field definitions in use.
Table 4 OBR Field Definitions
Field/ Delimiter Data Recommended Description Example

Name Type Max Length
Filler Order EI 22 Used as sample ID in 20121207011
Number +
sample analysis result
messages.
Used as QC file No. in
QC messages.
Requested TS 26 Draw time. 20121207080000
Date/time Used as the time
when the blood
sample is drawn.
Observation TS 26 Time of analysis. 20121207160000
Date/Time #
Collector XCN 60 Analysis orderer Mindray
Identifier * Here indicates the
person who orders the
analysis.
Relevant ST 300 Relevant clinical Influenza
Clinical Info.
information.
Can be used as the
clinical diagnostic
information of patient
information.
Specimen TS 26 Time when the sample 20121207083000
Received
is received.
Date/Time *
Used as the time
when the analysis is
ordered.
Specimen CM 300 Source of the sample.
Source *
Value definitions in
HL7:
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.
Analysis Result Definition
The OBX (Observation/Result) segment contains the parameter information of each test result.
See the following table for the communication data.
Table 5 Data type and Coding system
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 30525-0Âge^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
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%
~-3 %^LN
32517 32517-5^CD8+T%
~-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.2.2 MRFlow as TCP Client

After the MRFlow starts up or communication setup is modified, the system will try to reconnect
to LIS once. If the connection is not established in 10s, it is regarded as failed. But the
connection failing is not reported as an error on the software screen, and the system will not try
to reconnect unless the user initiate a communication call.
If the connection is not built up, the TCP client will try to reconnect when there is a
communication call. If the connection is not established in 10s, a communication error will be
reported and the communication will be canceled.
If the connection is established successfully, it will sustain until the communication setup is
modified or the MRFlow is closed.
C.2.3 HL7 Network Communication

When the MRFlow serves as TCP client or server in communication between network
interfaces, the message transmission is different from that between serial interfaces.
As for 1-way LIS communication messages like the analysis results of blood or control
samples, you can select synchronous response in HL7 protocol, which means after the
MRFlow sends a message, it will send the next message after receiving the response from LIS
or after response time-out.
While saving worklist, or run a count without worklist, the MRFlow initiates a LIS search
request, and LIS responds to the request in 10s. If the response is received successfully, the
MRFlow will save the information or run the count in the mode acquired from LIS.
C.2.4 ASTM Communication

ASTM is different from the other two protocols as it defines an independent communication
control protocol based on TCP/IP and serial interface communication. In the ASTM protocol,
the data transmission process has two levels: message and data frame. See 0. All the
messages need to be transmitted in the form of data frame, so the smallest unit of the
communication control defined in this section is frame.
Note: in communication between network interfaces, there are more one-byte control
C-10
characters (like ENQ, ACK, NAK, EOT, etc.). To reduce the responding time, it is suggest
disabling the "No Delay" function.
Sending Message
Figure 5 Sending a message from MRFlow to LIS
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
Figure 6 Resending data
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
Figure 7 2-Way LIS communication from MRFlow to 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.
C.3.2 Low-Level Transmission Protocol

The MRFlow communicates through TCP or serial port. See Connection Control for details.
C.3.3 HL7 Message Level Protocol

HL7 Protocol Overview
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:
<SB> = Start Block character (1 byte)

ASCII <VT>, i.e. <0x0B>. Do not confuse with the SOH or STX character in ASCII.
ddddd = Data (variable number of bytes)

ddddd is the effective data of HL7 message and expressed in the form of string. For
the strings used in the HL7 interface messages of the MRFlow, the UTF-8 code is used.
<EB> = End Block character (1 byte)

ASCII <FS>, i.e. <0x1C>. Do not confuse with the ETX or EOT character in ASCII.
<CR> = Carriage Return (1 byte)

ASCII carriage return character, i.e. <0x0D>.
C-14
Duplex Communication Process
1) The MRFlow directly sends the analysis results (or QC data) to LIS, as shown in the
figure below.
R01 event: MRFlow

send analysis results
to LIS initiatively.
Both analysis results
and QC data can be
sent in this way.
ORU^R01
MRFlow LIS
ACK^R01
Figure 8 Analysis results (QC data) communication process
2) Worklist information request.

Worklist belongs to the Order message. Thus, the corresponding HL7 messages: ORM
(General Order Message), ORR (General Order Response Message) can be used. The
communication process is shown in the figure below.
ORMÔ01
MRFlow LIS
ORRÔ02
Figure 9 Worklist request communication process
Mostly used messages:
ORU^R01 message: it is mostly used for the transmission of the analysis results
and QC data.
ORU Observational Results (Unsolicited) Description
MSH Message Header, mandatory, including the communication information like

message No., sending time, message delimiter and coding method, etc.
{
PID Patient demographic information, including patient name, gender, patient ID,
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.
}
}
ACK^R01 message: it confirms the receival of ORU^R01 message.

ACK Acknowledgment Description
MSH Message header

MSA message acknowledgment, describing whether it has received the
transmitted message
ORMÔ01 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
MSH Message header

{ORC} Common message of Order, including the ID information of the sample
searched
ORRÔ02 Message: acknowledgement of the ORMÔ01 message. Here, returning the

completed information of order (i.e. worklist).
ORRÔ02 General Order Response Message
Description
MSH Message header

MSA Message acknowledgment
[PID patient information
[PV1]] patient visit information
{
ORC Common message of Order, including the sample ID
[
OBR Sample information
{[OBX]} Data of other sample information, including analysis mode, etc.
]
}
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.
2. Field name: the logic sense of the field.
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.
5. Description: description to the value of the field.
6. Example: example of the fields.
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.
Table 6 MSH Field Definitions
No. Field/Deli Data Recommende Description Example

miter Type d Max Length
Name
1 Field ST 1 Includes the delimiter of |
Delimiter the first field after the
segment name; used to
determine the delimiter
values of the rest part of
the message.
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
typeêvent 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
The MSA (Message Acknowledgement) segment contains message acknowledge information.

Message example:
MSA|AA|1
C-18
Table 7 MSA Field Definitions
No. Field/Delimiter Data Recommended Description Example

1 Acknowledgment ID 2 Acknowledgement AA
Code code:―AA‖- received; ―AE‖
– error; ―AR‖- rejected.
2 Message Control ST 20 Message control ID, 1
ID consistent with the MSH-10
of the received message
6 Error Condition CE 100 Error condition (status
code), can be selected to
transmit, and contains error
condition descriptions; see
Table 8 Error Codes of
MSA-6 Field for the values.
Table 8 Error Codes of MSA-6 Field
Status Code Status Text (MSA-3) Description/Remark

(MSA-6)
Succeeded: AA
0 Message accepted Succeed
Error status code: AE
100 Segment sequence Segment sequence in the message is wrong,
error required segment missing
101 Required field Required field in a segment missing
missing
102 Data type error Segment data type error, e.g. data type is
character instead of numeric
103 Table value not found Table value not found; not used temporarily
Rejected status AR
code:
200 Unsupported Message type not supported
message type
201 Unsupported event Event code not supported
code
202 Unsupported Processing ID not supported
processing id
203 Unsupported version Version ID not supported
id
204 Unknown key Unknown key identifier, e.g. transmitting a
identifier nonexistent patient information
205 Duplicate key Repeated key words existed
identifier
206 Application record Issues cannot be executed in the application
locked saving level, e.g. database is locked
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.
Table 9 PID Field Definitions

1 Set ID - PID SI 4 Serial No., used to 1
identify different PID
segments in a
message
3 Patient CX 20 Used as patient ID in C1^^^^MR
Identifier List
the sample analysis
result messages, in the
form of
"MR"Number^^^^MR‖.
Used as batch No. of
control in QC
messages.
5 Patient Name XPN 48 Patient name (consists Liu
of FirstName and
LastName), in the form
of
"LastName^FirstName"
7 Date/Time of TS 26 Used as time of birth 20130419104618
Birth
in sample informatio
n messages.
In the form of YYYY
[MM[DD[HH[MM[S
S]]]]].
Used as expiration da
te of the control in Q
C messages.
8 Sex IS 1 Gender, string. Same F

with those on the
screen
PV1
The PV1 (Patient Visit) segment contains the patient visit information.
C-20
Message example:
PV1|1|Outpatient|Medicine^^BN1|||||||||||||||||MedicalInsurance
Table 10 PV1 Field Definitions

1 Set ID - PV1 SI 4 Serial No., used to identify 1
different PV1 segments in a
message.
2 Patient Class IS 1 Patient type, string, content Outpatient
not defined.
3 Assigned Patient PL 80 Patient location information, Internal
Location in the form of "Department^ Medicine
^ Bed No."
20 Financial Class FC 50 Payer, string, content not Patient
defined.
OBR
The OBR (Observation Request) segment contains the test report information.
Message example:
OBR|1|| TestSampleID1|00001Âutomated Count^99MRC||20121207080000|201212071600
00|||Li|||Influenza|20121207083000||||||||||HM||||||||Mindray
Table 11 OBR Field Definitions
No. Field/ Data Recommended Description Example

Delimiter Type Max Length
Name
1 Set SI 10 Serial No., used to 1
ID - OBR identify different
OBR segments in a
message
2 Placer Order EI 22 Used as sample ID
Number in the worklist
request response
messages (i.e.
ORRÔ02
messages).
3 Filler Order EI 22 Used as sample ID 20121207011
Number +
in sample analysis
result messages.
Used as QC file No.
in QC messages.
4 Universal CE 200 Universal service 00001Âutomated
Service ID ID, used to identify Count^99MRC
different types of
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
Table 12 OBX Field Definitions

Name
1 Set ID - SI 10 Serial No., used to 6
OBX identify different OBX
segments in a
message.
2 Value Type ID 3 Data type of the NM
analysis result. Value:
"ST", "NM", "ED",
"IS", etc.
3 Observatio CE 590 Analysis item identifi 6690-2^WBC^LN
n Identifier
er.
In the form of "ID^N
ameÊncodeSys", w
here ID is the identif
ier of the analysis it
em; Name is the de
scription of the item;
EncodeSys is the c
oding system of the
item.
See the configuratio
n files and C.7 App
endix: Message Codi
ng Definitionfor the
values of the codes
for different items.
Note: ID and
EncodeSys are used
to identify different
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.
Table 13 ORC Field Definitions

Name
1 Order ID 2 Order control. RF
Control
In ORM message, the
value is "RF", which
means "re-fill order
request"
In ORR message, the
value is "AF", which
means "acknowledge
order re-filling"
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.
C.3.5 Complete Message Examples

The two message examples below shows the communication process of sample data
Sample Message
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|00001Âutomated
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|30525-0Âge^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
In synchronous communication of MRFlow, each analysis result message need a response
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
2-Way LIS/HIS Request Message
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
ORMÔ01. 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||ORMÔ01|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
ORRÔ02, 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||ORRÔ02|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||00001Âutomated
Count^99MRC||20130422091323||||sender||||20130422185915||||||||||HM
OBX|1|IS|05007^Project Type^99MRC||CD348||||||F
OBX|2|NM|30525-0Âge^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||ORRÔ02|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.
C.4.2 Protocol Levels
Figure 10 Levels of the ASTM protocol
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.
C.4.3 Frame Structure

All the frame control characters are ASCII characters which shall not be contained in the text
part of the frame. As required by the protocol, the maximal data length of a frame is 64,000
bytes (including the control character).
Frame Description
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
Key Dec Hex Printable Description

(decimal) (hexadecimal)
^B 2 02 <STX> Frame start character
^C 3 03 <ETX> End frame, text end character
^J 10 0A <LF> Frame end line feed

character
^M 13 0D <CR> Frame end carriage return

character
^W 23 17 <ETB> Middle frame, text end

character
Ê 5 05 <ENQ> Connection establishing

request (transmission
preparation) character
^D 4 04 <EOT> Transmission completion

character
^F 6 06 <ACK> Successful reception

response character
Û 21 15 <NAK> Re-sent response
Middle Frame
Structure of a middle frame:

<STX> FN Text <ETB> C1 C2 <CR><LF>
End Frame
Structure of an end frame:

<STX> FN Text <ETB> C1 C2 <CR><LF>
Check and Calculation
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.
C.4.4 Message Structure

Message Description
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.
Maximal field length: no limit to the length of a field.

Maximal record length: no limit to the length of a record, only depends on the length limit for
character processing.
Message Coding
1） Character Limit and Coding

The message transmission is text transmission, so it is not allowed to use invisible characters.
For the universal ASCII characters:
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.
2） Binary Data Coding

For raw binary data, they need to be converted to strings using BASE64 (SeeC.8) for
transmission.
Since there may be big-endian and little-endian difference at the sending end and the
receiving end, in the transmission process of raw data, if the smallest unit data of the raw data
needs to be expressed by 2 bytes or more, the raw data need to be converted to network byte
order before being coded using Base64. Take the transmission of 32-bit integer digit group as
an example. The smallest unit of the raw data (integer digit group) is integer that is expressed
by 4 bytes, so before Base64 coding, the integer digit group needs to be converted to one-byte
digit group based in network byte order, and then converted to text using Base64.
Note: the characters are case sensitive.
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 ^
Escape 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
As defined in ASTM, the following record types are involved:

Record type Type identifier Remarks
Message Header Record H Message Header Record
Patient Information Record P Patient information record
Test Order Record O Test order record

Result Record R Result record
Comment Record C (Not in use)
Scientific Record S (Not in use)

Manufacturer Information M (Not in use)
Record
Request Information Record Q Request information record
(bi-directional LIS)
Message Terminator Record L Message terminator record
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.4.5 Message Records

In ASTM protocol, the unique identifiers for sample property, parameter result are coded using
Lonic, which is the same with that of HL7. See C.7 for code values. What is different from HL7
is that in ASTM, the "EncodeSys" is not transmitted), and only "ID" and "Name" are transmitted
only.
Note: in the record definition tables, the right-aligned and italic parts are components, others
are fields. The components below a field are the components of this field; if there is no
component below a field, it means it is a single-component field.
C-34
Message Header and terminator Records
1) Message Header Record

The first record of every message is called message header record,
which consists of record delimiter definition, instrument name, instrument ID, protocol version
number, message creation time, etc.
Field Name Field Value Note:
Sequence Example
Number
Record Type ID 1 H Record type field; value fixed
Delimiter Definition 2 |\^& ASTM delimiter set; value fixed
Message Control ID 3 1 Message control ID field
Sender Name or ID 5
Manufacturer Mindray Fixed
Instrument Model MRFlow Fixed
Protocol Version Reserved
Special Instructions 11 Message text type field. See C.7
Table 7 for values.
Name Automated Count "Name" item
ID 00001 "ID" item
Processing ID 12 P Current message type; fixed to be
"P" indicating sample messages.
Version Number 13 LIS2-A2 Version number of ASTM; fixed
Date and Time of 14 20100208145026 Time of message transmission;
Message use current system time; in the
format of YYYYMMDDHHMMSS
Message Control ID: the unique identifier of a message Commonly starts from 1.
Taking the communication of sample analysis result as an example, the complete message
header is shown below:
1H|\^&|1||Mindray^ BriCyte E6^||||||Automated
Count^00001|P|LIS2-A2|20100208145026<CR>
Note: "<CR>" stands for carriage return.
2) Message Terminator Record

The last record of every message is called message terminator record, which is defined as
follows:
Sequence Example
Number
Record Type ID 1 L Record type field; value fixed
Sequence Number 2 1 Sequence number of record; fixed
C-35
Termination Code 3 N Termination code; value: "N"; fixed
A complete message terminator record is shown as follows:
L|1|N<CR>
Patient Information Record
Mainly includes patient ID, patient name, date of birth, age, physician, department, etc.
Used in sample analysis result message and worklist request response message.

Sequence Example
Number
Record Type 1 P Fixed
Sequence Number 2 1 Record sequence number; see
C.4.4 for details
Patient ID Number 3 5 333 Patient ID
Patient Name 6 Patient name
First name FirstName
Last name LastName
Birthdate 8
Date of birth 20091220000000 YYYYMMDDHHMMSS
Age 2
Age unit Y Values of age unit:
Null
Y: year
M: month
W: week
D: day
H: hour
Patient Sex 9 Female Entry by the operator (string)
Admission Status 25 Emergency Department, string displayed on
screen
Location 26
Inpatient zone EA String displayed on screen
Bed No. 32~-1 String displayed on screen
Complete record example:
P|1|||333|FirstName^LastName||20091220000000^2^Y|Female||||||||||||||||Emergency|EA^32-1
<CR>.
Test Order Record
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)

Sequence Example
Number
Record Type ID 1 O Fixed
C.4.4 for details
Specimen ID 3 K11321 Sample ID
Requested Date and 7 20100613010203 Blood sample: time of analysis;
Time QC: time of QC run
Collection Date and 8 20100612153501 Time of sample collection
Time
Collector ID 11 Jones The person who ordered the
analysis
Relevant Clinical 14 Diagnosis Clinical diagnosis
Information
Date/Time Specimen 15 20100612153501 Date/Time when the specimen is
Received received
Specimen Descriptor 16
Specimen Type Sample Type Sample type
Specimen Source Reserved
Ordering Physician 17 XQRD Blood sample: operator; QC:
operator
User Field Number 1 19 Alice User-defined; used for validator
here
User Field Number 2 20 User-defined; used for time of
validation here
Date/Time Results 23 20111220153501 Report time
Reported or Last
Modified
Report Type 26 F Report types:
F – final results; not request
response; fixed to be F
Q – has result for request
Y – no result for request
O|1|K11321||||20100613010203|20100612153501|||Jones|||Diagnosis|20100612153501|Sam
ple Type^|XQRD||Alice|||20111220153501|||F<CR>
Analysis Result record
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.

Sequence Example
Number
Record Type ID 1 R Fixed
C.4.4 for details
Universal Test ID 3
Universal Test ID Universal test ID; reserved
Universal Test ID WBC Name. See C.7 Table 16 Data
Name type and Coding system
Universal Test ID ID type; reserved
Type
Manufacturer‘s or 6690~-2 ID. See C.7Table 16 Data type
Local Code and Coding system
Data or 4 2.30 Result data
Measurement Value
Units 5 10^9/L Unit of result; use the units
displayed on screen
Reference Ranges 6 Reference range
Lower limit 4.00
Upper limit 12.00
Result Abnormal 7 Result flags
Flags
High/Low flags L H – higher than upper limit
L – lower than lower limit
Result edited flag e E – result edited flag
e – result changed due to the
manual editing of another
parameter result based on which it
is calculated
Null if the result is not edited
Suspicious flag N N - normal
A - abnormal
Reagent expiration O O – reagent expired
flag Null if the reagent is not expired
Temperature flag T T - instrument overtemperature
Null if no overtemperature
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
R|14|^WBC^^6690-2|2.30|10&S&9/L|4.00^12.00|Lê^NÔ^T^C^V<CR>
Request Searching Record
Used in bi-directional LIS request (worklist request).

Sequence Example
Number
Record Type ID 1 Q Fixed
C.4.4 for details
Starting Range ID 3 K11321 Sample ID in the worklist to be
Number requested
Beginning Request 7 20111220153501 Time when the request begins;
Results data and use the current system time;
Time format: YYYYMMDDHHMMSS
Q|1|K11321||||20111220153501<CR>
C.4.6 Message for Communication

Note: the message examples contain complete frame header and terminator. Since special
characters may have problems in display, the frame header and terminator are replaced by
strings that can be displayed properly. E.g. use <STX> for frame header. The frames in the
example after conversion should be continuous, but the frames are separated by line feed
characters for better readability.
Sample Analysis Result Message
1) Record Structure
Record Structure:
1 Header
2 Patient
3 Order
4 Result1
5 Result2
6 Result3
......
C-39
n Message Terminator
2) Content of Sample Data

Content of sample analysis result message for communication:
Record Record Value Field Position: Component Value Value Description
Type Content
H Record header 12: message Sample Analysis See the table of OBR-4
type Result code*
P Patient 5: Patient ID The patient ID
Demographics displayed on
screen
6: Patient name First name First name of patient
Last Name Last name of patient
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 What displayed on
Information screen
7: time of Time of analysis YYYYMMDDHHMMSS;
analysis what displayed on
screen
8: Time of Time of sample YYYYMMDDHHMMSS;
sample collection what displayed on
collection screen
11: The person The person who String
who ordered the ordered the
analysis analysis
14: clinical Clinical What displayed on
diagnosis diagnosis screen
15: Date/Time Date/Time when YYYYMMDDHHMMSS;
when the the specimen is what displayed on
specimen is received screen
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
3) Example of Sample Analysis Result Message

<STX>1H|\^&|1||Mindray^MRFlow^||||||Automated
Count^00001|P|LIS2-A2|20130424140019<CR><ETB>8F<CR><LF><STX>2P|1|||200456|^tu
fk||20120430173815^1^yr|male||||||||||||||||dept|area^205<CR><ETB>9C<CR><LF><STX>3O|1
|1||||20130420125148|20130415173815|||sender|||gaomap|20130416173815|sampletype^|Ad
min||Admin|20130420125305||||||F<CR><ETB>CD<CR><LF><STX>4R|1|^Charge
type^^01015|chargetype|<CR><ETB>1D<CR><LF><STX>5R|2|^Patient
type^^01016|patienttype|<CR><ETB>36<CR><LF><STX>6R|3|^Project
Type^^05007|T/B/NK-Auto|<CR><ETB>BA<CR><LF><STX>7R|4|^T#^^20598-9|37037.000|
个
/ul<CR><ETB>D1<CR><LF><STX>0R|5|^T%^^20599-7|100.00|%<CR><ETB>F8<CR><LF>
<STX>1R|6|^B#^^20592-2|0.000| 个
/ul<CR><ETB>DA<CR><LF><STX>2R|7|^B%^^20593-0|0.00|%<CR><ETB>7C<CR><LF><
STX>3R|8|^NK%^^20620-1|0.00|%<CR><ETB>CD<CR><LF><STX>4R|9|^CD4+T%#^^3251
5-9|37037.000| 个
/ul<CR><ETB>D6<CR><LF><STX>5R|10|^CD4+T%%^^32516-7|100.00|%<CR><ETB>2C<
CR><LF><STX>6R|11|^CD8+T%#^^32517-5|37025.000| 个
/ul<CR><ETB>00<CR><LF><STX>7R|12|^CD8+T%%^^32518-3|99.97|%<CR><ETB>23<C
R><LF><STX>0R|13|^CD4+T/CD8+T^^20607-8|1.00|<CR><ETB>C7<CR><LF><STX>1L|1|
N<CR><ETB>01<CR><LF>
2-Way LIS Request Message
1) Record Structure
Record Structure:
1 Header
2 Request
3 Message Terminator
2) Content of Request Message
Content of bidirectional LIS request:
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
3) Example of Request Message

<STX>1H|\^&|1||Mindray^MRFlow^||||||Worksheet
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
2) Content of Request Response

Result of request response
Record Record Value Field Position: Component Value Value Description
Type Content
H Record 3: message ID Message ID Use the ID of the
header request message
12: message type Result of worklist See the table of OBR-4
request code*
P Patient 5: Patient ID The patient ID
Demographics displayed on
screen
6: Patient name First name First name of patient
Last Name Last name of patient
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
3) Example of Request Response Message

<STX>1H|\^&|1||LISSimulator^LIS||||||Worksheet
response^00011|P|LIS2-A2|20130425092451<CR><ETB>3C<CR><LF>
<STX>2P|1|||20123|fisrtName^LastName||20120422192223^12^d|male||||||||||||||||dept45|area
^234<CR><ETB>78<CR><LF>
<STX>3O|1|1|||||20130422091323|||sender||||20130422185915|||||||||||AA<CR><ETB>9B<CR
><LF>
<STX>4R|1|^Project Type^^05007|CD348<CR><ETB>0D<CR><LF>
<STX>5R|2|^Remark^^01001|<CR><ETB>A8<CR><LF>
<STX>6R|3|^Patient type^^01016|waike<CR><ETB>16<CR><LF>
<STX>7L|1|N<CR><ETB>07<CR><LF>
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:
Table 14 HL7 Delimiters
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.5.2 Principles of Escape Character Conversion

For the field data of ST, TX, FT, and CF, etc. delimiters may be used in strings like remarks,
clinical diagnosis and customized gender etc. When coding, the delimiters in the original
strings shall be converted to escape sequence; which is restored in decoding. The principles
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.
 CX - Extended composite ID with check digit

<ID (ST)> ^ <check digit (ST)> ^ <code identifying the check digit scheme employed (ID)> ^ <
assigning authority (HD)> ^ <identifier type code (IS)> ^ < assigning facility (HD)>
 ED – Encapsulate Data
<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)>
Used only as part of EI and other data types.
 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.
 IS - Coded value for user-defined tables

The value of such a field follows the formatting rules for an ST field except that it is drawn from
a site-defined (or user-defined) table of legal values. There shall be an HL7 table number
associated with IS data types.
 ID - Coded values for HL7 tables

The value of such a field follows the formatting rules for an ST field except that it is drawn from
a table of legal values. There shall be an HL7 table number associated with ID data types.
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
YYYY[MM[DD[HHMM[SS[.S[S[S[S]]]]]]]][+/-ZZZZ] ^ <degree of precision>
 XCN - Extended composite ID number and name

In Version 2.3, use instead of the CN data type. <ID number (ST)> ^ <family name (ST)> &
<last_name_prefix (ST) ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR
or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <source table (IS)> ^
<assigning authority (HD)> ^ <name type code (ID)> ^ <identifier check digit (ST)> ^ <code
identifying the check digit scheme employed (ID)> ^ <identifier type code (IS)> ^ <assigning
facility (HD)> ^ <name representation code (ID)>
 XPN - Extended person name

In Version 2.3, replaces the PN data type. <family name (ST)> ^ <given name (ST)> &
<last_name_prefix (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^
<prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^ <name type code (ID) > ^ <name
representation code (ID)>
 VID - Version identifier

<version ID (ID)> ^ <internationalization code (CE)> ^ <international version ID (CE)>
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^NameÊncodeSys‖, 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.
Table 15 OBR-4 and ASTM Message Type Codes

Code
Data Name EncodeSys Remarks
(ID)
Sample Analysis Result 00001 Automated Count 99MRC
Worksheet
Worklist search 00010 99MRC
Request
Response to worklist Worksheet
00011 99MRC
request Response
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^NameÊncodeSys‖;
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.
Table 16 Data type and Coding system
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 30525-0Âge^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
1^99MRC
01010^Custom
2^99MRC
01011^Custom
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%
-7 %^LN
32515 32515-9^CD4_T%
-9 #^LN
32518 32518-3^CD8+T%
-3 %^LN
32517 32517-5^CD8+T%
-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
Table 17 Parameter Units in Communication
Parameter Units in Parameter Units in

Software Communication (OBX-6)
10^12/L 10*12/L
10^9/L 10*9/L
10^4/L 10*4/L
10^3/L 10*3/L
10^6/uL 10*6/uL
10^4/uL 10*4/uL
10^3/uL 10*3/uL
10^2/uL 10*2/uL
% %
3. Some OBX messages use custom enumeration values. See Table 13 for the meaning of the
values.
Table 18 HL7 and ASTM Enumeration Definitions
Data Value Enumeration

Panel (Project Type) Value enumeration:
"CD348"
"TBNK"
"HLA-B27"
"BNK"
Age Unit Value enumeration:
"yr"- year
"mo"- month
"wk"- week
"d"- day
"hr"-hour
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.
Raw data： 15H A3H 4BH

Binary data 00010101 10100011 01001011
6-bit groups obtained after dividing 000101 011010 001101 001011
Corresponding codes 5H 1AH 0DH 0BH
Corresponding characters F a N L
Table 19 Base64 Mapping
Value/Code Value/Code Value/Code Value/Code

0A 17 R 34 I 51 z
1B 18 S 35 j 52 0
2C 19 T 36 k 53 1
3D 20 U 37 l 54 2
4E 21 V 38 m 55 3
5F 22 W 39 n 56 4
6G 23 X 40 o 57 5
7H 24 Y 41 p 58 6
8I 25 Z 42 q 59 7
9J 26 a 43 r 60 8
10 K 27 b 44 s 61 9
11 L 28 c 45 t 62 +
12 M 29 d 46 u 63 /
13 N 30 e 47 v
14 O 31 f 48 w (pad) =
15 P 32 g 49 x
16 Q 33 h 50 y
2. Repeat step 1 continuously till the whole data stream is encoded.

When the data left is less than 3 bytes, 0 is added to the right to complement. If the 6-bit
groups obtained is composed of the complement bit (0) only, then it is mapped to the ―=‖
character. When there is the last one byte left, there will be two ―=‖ characters in the obtained
coding string; when two bytes are left, then the obtained coding string consists of one ―=‖
character. See the two examples below:
① Raw data 0AH
00001010
Data obtained after complementing 00001010 00000000 00000000
6-bit groups obtained after dividing 000010 100000 000000 000000
Corresponding codes 02H 20H 00H 00H
Corresponding characters C g = =
② Raw data 0AH 0BH

00001010 00001011
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)

2015 - 12 - 1114 - 24 - 22BriCyte - E6 - Operator's Manual - V4.0 - EN

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

2015 - 12 - 1114 - 24 - 22BriCyte - E6 - Operator's Manual - V4.0 - EN

Uploaded by

Copyright:

Available Formats

BriCyte E6

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

are the trademarks, registered or otherwise, of Mindray in

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

 This cytometer must be operated by skilled/trained clinical professionals.

 It is important for the hospital or organization that employs this cytometer to

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

This warranty shall not extend to:

Customer Service Department

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Eiffestraβe 80, Hamburg 20537, Germany

2 Understanding Your Cytometer ....................................................................... 2-1

3 Understanding the System Principles............................................................. 3-1

3.4.3 Drive and Monitor Unit ........................................................................... 3-8

4 Installing Your Cytometer ................................................................................ 4-1

5 Customizing the Cytometer Software ............................................................. 5-1

6 Operating Your Cytometer ............................................................................... 6-1

6.8 Running Samples - Manual Loading ................................................................. 6-28

7 Using the QC Programs ................................................................................... 7-1

8 Servicing Your Cytometer................................................................................ 8-1

8.4.6 Photocoupler and switch ..................................................................... 8-12

9 Troubleshooting ............................................................................................... 9-1

10 Appendices ..................................................................................................... A-1

1.2 Who Should Read This Manual

 learn about the BriCyte E6 hardware and software;

 set up system parameters;

 perform daily operating task;

 perform system maintenance and troubleshooting.

1.3 How to Find Information

If you want to … See...

1.4 Conventions Used in This Manual

1.5 Precautions, Limitations and Hazards

read the statement below the symbol. The statement is

 It is important for the hospital or organization that employs this cytometer to

 Please take action to any alarm and problem indication immediately.

 Do not touch the moving parts.

 Contact the manufacturer or authorized distributors in time if any damaged

 Discard the cytometer according to government regulations.

should be used, in order to prevent from human injury.

 Avoid direct contact with patient samples.

 The sample probe may contain biohazardous materials. Exercise caution to

 Be sure to back up important data regularly in case of data loss by accident.

 When the performance of the cytometer changes significantly, contact our

 Install software authorized by the manufacturer only on the PC.

 Take proper measures to prevent the reagents from contamination.

any questions, contact our Customer Service or your local distributor.

 Only one radio button can be chosen for one setting.

 The vertexes of polygonal gate must be closed.

 If network card（including virtual network card）of the PC is changed after

 The password cannot be null and up to 12 characters can be entered.

 The note can be null and up to 30 characters can be entered.

 The current user logged in cannot be deleted.

reagents as instructed by instructions for use of the reagents.

 When the cytometer is running, or the printing or exporting task is ongoing,

 Be sure to use clean medical materials.

loading model shall be no less than 100 μL.

 25 characters are allowed for sample ID maximally (including prefix).

 16 tubes can be added at most

 The receive date/time cannot be earlier than the collection date/time

 Be sure to avoid spillage of liquid caused by excessive liquid volume in the