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Manual de Usuario - Ingles PDF
Manual de Usuario - Ingles PDF
Operator’s Manual
© 2009-2012 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2012-01.
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.
derivative work of this manual in any manner whatsoever without the written permission of
informational or editorial purposes. They are the property of their respective owners.
All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only
if:
all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and
local requirements; and
I
WARNING
It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or personal injury.
Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.
NOTE
This equipment must be operated by skilled/trained clinical professionals.
II
Warranty
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the
improper use or application of the product or the use of parts or accessories not approved by
Mindray or repairs by people other than Mindray authorized personnel.
Malfunction of the instrument or part whose serial number is not legible enough.
III
Company Contact
Tel: 0049-40-2513175
Fax: 0049-40-255726
IV
Table of Contents
1
Table of Contents
12 Appendices ..............................................................................................A-1
A Index ......................................................................................................A-1
B Specifications .........................................................................................B-1
C Precautions, Limitations and Hazards ...................................................C-1
D Communication ......................................................................................D-1
2
1 Using This Manual
1.1 Introduction
This chapter explains how to use your BC-5800 operator's manual, which is shipped with your
BC-5800 AUTO HEMATOLOGY ANALYZER and contains reference information about the
BC-5800 and procedures for operating, troubleshooting and maintaining the analyzer. Read
this manual carefully before operating your analyzer and operate your analyzer strictly as
instructed in this manual.
NOTE
Be sure to operate your analyzer strictly as instructed in this manual.
1-1
Using This Manual
This manual contains information written for clinical laboratory professionals to:
1-2
Using This Manual
This operation manual comprises 11 chapters and 4 appendices. Refer to the table below to
find the information you need.
learn about the intended use and parameters of the BC-5800 Chapter 2 Understanding
Your Analyzer
learn about the hardware and software of the BC-5800 Chapter 2 Understanding
Your Analyzer
learn about how the BC-5800 works Chapter 3 Understanding the
System Principles
learn about the installation requirements of the BC-5800 Chapter 4 Installing Your
Analyzer
learn about how to define/adjust system settings Chapter 5 Customizing the
Analyzer Software
learn about how to use the BC-5800 to perform your daily Chapter 6 Operating Your
operating tasks Analyzer
learn about how to review the saved analysis results Chapter 7 Reviewing Sample
Results
learn about how to use the quality control programs Chapter 8 Using the QC
Programs
learn about how to calibrate the BC-5800 Chapter 9 Using the
Calibration Programs
learn about how to maintain/service the BC-5800 Chapter 10 Maintaining Your
Analyzer
learn about the meanings of the error messages and how to Chapter 11 Troubleshooting
correct the problems Your Analyzer
learn about the technical specifications of the BC-5800 Appendix B Specifications
see the summary of all safety messages included in this Appendix C Precautions,
manual Limitations and Hazards
learn about the communication protocol of the BC-5800 Appendix D Communication
1-3
Using This Manual
This manual uses certain typographical conventions to clarify meaning in the text:
all capital letters enclosed in [ ] indicate a key name (either on the pop-up keyboard or the
external keyboard), such as [ENTER].
all capital, bold and italic letters indicate a special operation defined in the following
section, such as CLICK.
bold letters included in “ “ indicate text you can find on the screen, such as “Clean”.
bold letters indicate chapter titles, such as Chapter 1 Using This Manual.
All illustrations in this manual are provided as examples only. They may not necessarily reflect
your analyzer setup or data displayed.
1-4
Using This Manual
to press the desired item on the screen lightly with your finger;
CLICK or
to CLICK the desired edit box and use the external keyboard or
the pop-up keyboard to enter the desired characters or digits;
ENTER
or
to move the cursor to the character or digit to the left of the one
you want to delete and press [DEL] on the external keyboard;
or
DELETE to move the cursor to the character or digit to the right of the
one you want to delete and press [BackSpace] on the external
keyboard (or the [←] key at the upper right corner of the
pop-up keyboard).
1-5
Using This Manual
1.6 Symbols
You may find the following symbols on the analyzer, reagents, controls or calibrators.
BIOLOGICAL RISK
HIGH VOLTAGE
1-6
Using This Manual
EARTH (GROUND)
ALTERNATING CURRENT
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
MANUFACTURER
TEMPERATURE LIMITATION
IRRITATING SUBSTANCE
1-7
Using This Manual
1-8
Using This Manual
(1)
To avoid electric shock, disconnect power cord prior to removing or replacing fuse.
1-9
Using This Manual
(1)
To avoid personal injury, after you lift the cover, be sure to fix it with the stop bar exactly as the
above figure shows.
(2)
Mechanical risk may exist if the protective cover is removed.
1-10
Using This Manual
Figure 1-3 Stop Bar Position (Top Cover and Left Door Removed)
(1)
To avoid personal injury, after you lift support plate of the circuit boards, be sure to fix it with the
stop bar exactly as the figure shows.
1-11
Using This Manual
Figure 1-4 Protective cover (Top Cover, Left Door, Right Door and Back Panel Removed)
(1)
Mechanical risk may exist if the protective cover is removed.
(2)
CAUTION: LASER RADIATION WHEN OPEN, AVOID DIRECT EYE EXPOSURE.
1-12
Using This Manual
(1)
To avoid personal injury, do not put your hand into the analyzer.
1-13
Using This Manual
(1)
To avoid damaging the pneumatic unit, do not block the vent at its back.
(2)
To avoid electric shock, disconnect power cord prior to removing or replacing fuse.
To avoid the compressor being damaged, wait at least 1 minute before restarting the
pneumatic unit.
(3)
To avoid damaging the pneumatic unit, do not block the vent at its back.
1-14
Using This Manual
(1)
To avoid personal injury, do not put hand into the fan.
(2)
To avoid personal injury, do not put hand into the fan.
(3)
WARNING: HIGH TEMPERATURE.
1-15
Using This Manual
(1)
Risk of electric shock. Do not touch. Cut off the power before maintenance.
(2)
Risk of electric shock. Do not touch. Cut off the power before maintenance.
(3)
Risk of electric shock. Do not touch. Cut off the power before maintenance.
1-16
2 Understanding Your Analyzer
2.1 Introduction
2-1
Understanding Your Analyzer
The BC-5800 Auto Hematology Analyzer is a quantitative, automated hematology analyzer for
In Vitro Diagnostic Use in clinical laboratories providing functions of blood cells counting, WBC
5-part differential and HGB concentration determination, etc.
NOTE
The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that
require additional studies.
The analyzer must be used in clinical laboratories with professional management competence.
This analyzer can not be used as portable device, and must be operated by skilled/trained
clinical professionals.
The analyzer is used for the quantitative determination of the following 25 basic parameters, 4
parameters for research use, 2 histograms and 2 scattergrams of blood samples.
2-2
Understanding Your Analyzer
2-3
Understanding Your Analyzer
BC-5800 AUTO HEMATOLOGY ANALYZER consists of the main unit (analyzer), pneumatic
unit and accessories.
2-4
Understanding Your Analyzer
2-5
Understanding Your Analyzer
2-6
Understanding Your Analyzer
1 --- RBC & HGB detecting unit 2 --- WBC detecting unit
3 --- RBC diluent unit 4 --- Open vial sampling & SRV (Sample
Rotator Valve) unit
5 --- Syringes
2-7
Understanding Your Analyzer
Figure 2-5 Inside front of the Analyzer(Front Cover Removed, Autoloader Configured)
2-8
Understanding Your Analyzer
2-9
Understanding Your Analyzer
2-10
Understanding Your Analyzer
2-11
Understanding Your Analyzer
2-12
Understanding Your Analyzer
CAUTION
To avoid damage, do not turn on/off the power of the analyzer continually in
a short time.
An external keyboard can be connected to a USB interface on the back of the analyzer. You
can use it to operate your analyzer.
Mouse (Optional)
A mouse can be connected to a USB interface on the back of the analyzer. You can use it to
operate your analyzer.
Printer (Optional)
An external printer can be connected to a USB interface on the back of the analyzer. You can
use it to print out a detailed report and other interested information displayed on the screen.
Scanner (Optional)
A bar-code scanner can be connected to a USB interface on the back of the analyzer. You can
use it to scan the bar-coded information into the analyzer.
Pneumatic Unit
The pneumatic unit provides pressure and vacuum for the analyzer.
2-13
Understanding Your Analyzer
NOTE
Do not adjust the pneumatic relief valve. Contact Mindray customer service
department or your local distributor if necessary.
2-14
Understanding Your Analyzer
After the starting procedure, you will enter the main screen shown in Figure 2-10. CLICK any
icon to enter the desired function screen as instructed below.
2-15
Understanding Your Analyzer
CLICK the “Count” icon at the main screen to enter the “Count” screen shown in Figure 2-11.
Title area
The Title area displays the title of the current screen, which, in case of Figure 2-11, is “Count”.
CLICK this area and the help information of the “Count” screen will appear.
2-16
Understanding Your Analyzer
Status area
From left to right, they are:
1. Analysis status
The Analysis status area shows three statuses in different icons: red icon for waiting, green
icon for ready and flickering green icon for running.
NOTE
If a STAT sample is to be run, the yellow icon represents ready and the
flickering yellow icon represents running instead.
Waiting: it means the analyzer is not ready for the next run yet.
Ready: it means this analyzer is ready and you can proceed to analyze the next sample.
2. Print status
3. Transmission status
Gray icon: The communication device is not connected to the analyzer yet.
Icons are used to display the on/off status of the X-B analysis, gray icon for off and color icon
for on.
Icon is used to display the current input language of the pop-up keyboard and you can switch
to other language by clicking it.
2-17
Understanding Your Analyzer
EN English-US CN Chinese-CN
FR French DE German
IT Italian ES Spanish
RU Russian PT Portuguese
TR Turkish CZ Czech
PL Polish RO Romanian
GR Greek
NOTE
Please select the desired input language properly. Improper input language
may lead to confused screen display.
6. System time
2-18
Understanding Your Analyzer
Supposed you are to use key combination; for example, the [Ctrl+Shift], do as follows:
1. CLICK the [Ctrl] key.
2. CLICK the [Shift] key.
2-19
Understanding Your Analyzer
2.6.2 Form
You may find forms at screens like the "Review" screen (as shown in Figure 2-13). CLICK the
buttons on the right or at the bottom to view the information in the form. These buttons are:
2-20
Understanding Your Analyzer
The figure bellow shows a combo box. Click to display the pull-down list. When the
pull-down list is open, you can select the desired item by tapping it or using the [PageUp],
[PageDown], [↑], [↓] keys on the keyboard.
2-21
Understanding Your Analyzer
Because the analyzer, reagents, controls, and calibrators are components of a system,
performance of the system depends on the combined integrity of all components. You should
only use the Mindray-specified reagents (see Appendix B Specifications), which are
formulated specifically for the fluidic system of your analyzer in order to provide optimal system
performance. Do not use the analyzer with reagents from multiple suppliers. In such use, the
analyzer may not meet the performance specified in this manual and may provide unreliable
results. All references related to reagents in this manual refer to the reagents specifically
formulated for this analyzer.
Each reagent package must be examined before use. Inspect the package for signs of leakage
or moisture. Product integrity may be compromised in packages that have been damaged. If
there is evidence of leakage or improper handling, do not use the reagent.
NOTE
Store and use the reagents as instructed by instructions for use of the
reagents.
When you have changed the diluent or lyses, run a background to see if the
results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
After installing a new container of reagent, keep it still for a while before use.
2.7.1 Reagents
M-58D DILUENT
It is used to provide a stable environment for counting and sizing blood cells.
M-58LEO(I) LYSE
M-58LEO(II) LYSE
M-58LH LYSE
2-22
Understanding Your Analyzer
M-58LBA LYSE
It is used to lyse red blood cells and count WBCs and basophils.
PROBE CLEANSER
The controls are commercially prepared whole-blood products used to verify that the analyzer
is functioning properly. They are available in low, normal, and high levels. Daily use of all
levels verifies the operation of the analyzer and ensures reliable results are obtained. The
calibrators are commercially prepared whole-blood products used to calibrate the analyzer.
Read and follow the instructions for use to use the controls and calibrators. All references
related to controls and calibrators in this manual refer to the controls and calibrators reagents
specifically formulated for this analyzer. You should buy those controls and calibrators from
Mindray or Mindray-authorized distributors.
2-23
3 Understanding the System
Principles
3.1 Introduction
the Electrical Impedance method for determining the RBC and PLT data.
During each analysis cycle, the sample is aspirated, diluted and mixed before the
determination for each parameter is performed.
3-1
Understanding the System Principles
3.2 Aspiration
The analyzer offers an open vial sampling mode and autoloading mode (if configured). In the
open vial sampling mode, the analyzer can process two types of blood samples – whole blood
samples and prediluted blood samples. While in the autoloading mode, the analyzer can
process only whole blood samples.
If you are to analyze a whole blood sample in the autoloading mode, the analyzer will aspirate
180μL of the sample.
If you are to analyze a whole blood sample in the open vial sampling mode, the analyzer will
aspirate 120μL of the sample.
If you are to analyze a capillary blood sample in the open vial sampling mode, you should first
manually dilute the sample (40μL of capillary sample needs to be diluted by 120μL of diluent)
and then present the pre-diluted sample to the analyzer, which will aspirate 120μL of the
sample.
3-2
Understanding the System Principles
3.3 Dilution
In the sampling valve, the aspirated sample is quickly and precisely segmented into 4 portions.
The 4 portions are then diluted and processed by different reagents. After this, they are ready
for analysis.
This analyzer can process two types of blood samples – whole blood samples and prediluted
blood samples.
2.594mL of diluent
62.6μL
1.994mL of diluent
3-3
Understanding the System Principles
3-4
Understanding the System Principles
120μL of diluent
1:4 dilution
6μL
2.594mL of diluent
62.6μL
2.537mL of diluent
120μL of diluent
1:4 dilution
6μL
1.994mL of diluent
3-5
Understanding the System Principles
120μL of diluent
1:4 dilution
20μL
120μL of diluent
1:4 dilution
20μL
3-6
Understanding the System Principles
After a predetermined volume of blood is aspirated and diluted by a certain amount of reagent,
it is injected into the flow cell. Surrounded with sheath fluid (diluent), the blood cells pass
through the center of the flow cell in a single column at a faster speed. When the blood cells
suspended in the diluent pass through the flow cell, they are exposed to a laser beam. The
intensity of scatter light reflects the blood cell size and intracellular density. The low-angle
scattered light reflects cell size, and the high-angle scattered light reflects intracellular density
(nucleus size and density). The optical detector receives this scatter light and converts it into
electrical pulses. Pulse data collected can be used to draw a 2-dimensional distribution
(scattergram). As shown in Figure 3-2 and Figure 3-3, X-axis represents the intracellular
density and Y-axis the blood cell size. Various types of analysis data can then be obtained from
the scattergrams.
3-7
Understanding the System Principles
By analyzing the DIFF channel scattergram, the analyzer presents the Lym%, Mon%, Eos%
and Neu%.
By analyzing the BASO channel scattergram, the analyzer presents the WBC, Bas#, LIC#
(RUO) and Bas%.
3-8
Understanding the System Principles
WBC
WBC Sum of all particles in BAS channel except those in Ghost region
Basophilic leucocyte
Bas#
Bas% 100%
WBC
Lymphocyte percentage
Lymphocyte
Neutrophilic leucocyte
3-9
Understanding the System Principles
Mononuclear leucocyte
Eosinophilic leucocyte
3-10
Understanding the System Principles
Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L)
3.5.2 HGB
The HGB is calculated per the following equation and expressed in g/L.
Blank Photocurrent
HGB(g/L) Constant Ln
Sample Photocurrent
3-11
Understanding the System Principles
RBCs/PLTs are measured by the Electrical Impedance method. When blood cells in a certain
amount of sample pass through the aperture, they cause electrical resistance changes
between two electrodes. Electrodes are at sides of the aperture. The analyzer processes the
data of changes and then the RBC, PLT, MCV and MPV are presented.
Each pulse is amplified and compared to the internal reference voltage channel, which only
accepts the pulses of a certain amplitude. If the pulse generated is above the RBC/PLT lower
threshold, it is counted as a RBC/PLT. The analyzer presents the RBC/PLT histogram, whose
x-coordinate represents the cell volume(fL)and y-coordinate represents the number of the
cells.
3-12
Understanding the System Principles
The metering unit controlling the RBC/PLT count cycle consists of a metering tube with two
optical sensors mounted on it. This tube ensures that a precise amount of diluted sample is
measured during each count cycle. The exact amount is determined by the distance between
the two optical sensors. The diluent is used to create a meniscus in the metering tube. The
count cycle starts when the meniscus reaches the lower sensor and stops when the meniscus
reaches the upper sensor. The amount of time required for the meniscus to travel from the
lower sensor to the upper sensor is called the RBC Count Time and is measured in seconds.
At the end of the count cycle, the measured count time is compared to the pre-defined
reference count time. If the former is less than or greater than the latter by 2 seconds or more,
the analyzer will report a RBC bubble or RBC Clog error. Seeing the error message, refer to
Chapter 11 Troubleshooting Your Analyzer for solutions.
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes
3-13
Understanding the System Principles
RBC n 1012 / L
MCV
Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
expresses the result in fL.
This analyzer calculates the HCT (%), MCH (pg) and MCHC(g/L) as follows:
RBC MCV
HCT
10
HGB
MCH
RBC
HGB
MCHC 100
HCT
where the RBC is expressed in 1012/L, MCV in fL and HGB in g/L.
RDW-CV
Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation) of the
erythrocyte distribution width.
RDW-SD
RDW-SD (RBC Distribution Width – Standard Deviation, fL) is set on the 20% frequency level
with the peak taken as 100%, as Figure 3-6 shows.
Figure 3-6
PLT (109/L) is measured directly by counting the platelets passing through the aperture.
MPV
3-14
Understanding the System Principles
Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).
PDW
Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet size
distribution. Each PDW result is derived from the platelet histogram data and is reported as
10(GSD).
PCT
PLT MPV
PCT
10000
P-LCR
Platelet larger cell ratio (P-LCR) is the ratio of the larger platelet (volume larger than 12fL)
count to the total PLT count. This analyzer calculates the P-LCR based on the PLT histogram
and expresses the result in %. In Figure 3-7, S2 represents the number of larger platelet cells,
and S1+S2 represents the total PLT count.
Figure 3-7
P-LCC
This analyzer calculates the platelet large cell count (P-LCC) and expresses the result in 109/L.
P-LCC=PLT P-LCR
3-15
Understanding the System Principles
3.7 Wash
3-16
4 Installing Your Analyzer
4.1 Introduction
CAUTION
Installation by personnel not authorized or trained by Mindray may damage
your analyzer. Do not install your analyzer without the presence of
Mindray-authorized personnel.
Your analyzer is tested before it is shipped from the factory. International symbols and special
handling instructions tell the carrier how to treat this electronic instrument. When you receive
your analyzer, carefully inspect the carton. If you see any signs of mishandling or damage,
contact Mindray customer service department or your local distributor immediately.
4-1
Installing Your Analyzer
Before installation, you should ensure that the following space, power and environmental
requirements are met.
at least 100 cm on each side, which is the preferred access to perform service
procedures.
enough room on and below the countertop to accommodate the diluent, lyses, pneumatic
unit and waste containers.
WARNING
Make sure the analyzer is properly grounded.
Before turning on the analyzer, make sure the input voltage meets the
requirements.
4-2
Installing Your Analyzer
Running temperature: 10 ℃ - 40 ℃
The environment should be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.
Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
Do not use this analyzer in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper
operation.
Do not place the analyzer in direct sunlight or in front of a source of heat or drafts.
WARNING
Do not place the analyzer in a flammable or explosive environment.
CAUTION
Avoid the spillage of any reagent or liquid which may get into the analyzer
and cause damage.
NOTE
If the ambient temperature is outside the specified operating range, the
analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting Your Analyzer for
solutions.
4-3
Installing Your Analyzer
4-4
Installing Your Analyzer
4.3.2 Reagents
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according
to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not place reagents on or above the analyzer.
Do not remove the reagent cap assemblies while the analyzer is operating.
Connect the reagent lines as shown in Figure 4-2. Place lyses on the countertop, and the
diluent and waste container below the countertop. Be sure to keep all reagent lines isolated
from anything electrical.
4-5
Installing Your Analyzer
CAUTION
Do not connect or disconnect the printer, bar-code scanner, keyboard or
mouse when the analyzer is on.
Connect the optional equipment to the analyzer as shown in Figure 4-3 and Figure 4-4. The
operator shall make sure they are connected properly.
4-6
5 Customizing the Analyzer Software
5.1 Introduction
The BC-5800 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.
For the safety of the setting and data, the analyzer divides the operators to be the common
user and the administrator. The administrator authority includes all authorities of the common
user. This manual will explain how to customize your analyzer in the common user level and
the administrator level respectively.
5-1
Customizing the Analyzer Software
When you log in as a common user, CLICK the “Setup” button to enter the “Setup” screen of
the common user level shown in Figure 5-1.
5-2
Customizing the Analyzer Software
5.2.1 Settings
Date/Time
You can customize the date, time and the date format of the analyzer. The date and time at the
screen and the printout will change if the settings are changed.
The “Date/Time” screen is the default screen after you CLICK the “Setup” button. If the
current screen is not the “Date/Time” screen, CLICK the “Date/Time” button to enter the
“Date/Time” screen shown in Figure 5-2.
If the year you entered is out of the range of 2000 – 2036, a dialog box shown in Figure 5-3 will
pop up when you exit the date/time setup screen.
5-3
Customizing the Analyzer Software
CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” button
to reenter the valid date.
To exit the “Date/Time” screen, CLICK any other button at the left of the screen or any button
at the bottom. A dialog box shown in Figure 5-4 will pop up.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Assistance
Entering the “Assistant” screen
CLICK the “Assistant” button at the “Setup” screen to enter the “Assistant” screen shown in
Figure 5-5.
5-4
Customizing the Analyzer Software
If you have activated the reminder and selected the predilute mode, a dialog box will pop up
when the sample will be analyzed in the predilute mode. CLICK the “Ok” button to proceed
with the analysis or CLICK the “Cancel” button to exit.
To activate the reminder, CLICK the “Prompt” radio button. To deactivate the reminder, CLICK
the “No prompt” radio button. The default setting is “Prompt”.
To use the pop-up keyboard, CLICK the “Open” radio button so that you can enter information
by the pop-up keyboard. If not, CLICK the “Close” button and you can only enter information
5-5
Customizing the Analyzer Software
Two ID setup methods for new samples are provided for the open-vial sampling mode.
If “Auto increment” is selected, when there is a new sample to be run, the next ID increases
by 1 based on the current ID (if the current sample ID ends with a character, and “Auto
increment” is selected, the next ID will stay the same); if “Manual entry” is selected, when
there is a new sample to be run, the default next ID is empty.
The default setting of the analyzer disables this funtction, ID of invalid samples is set as
“Invalid”; click the “Open” radio button, the ID of invalid samples will turn to “Invalid
number @tube No.–rack No.”(the number can be 1 to 99).
When you use a waste container to collect the waste, CLICK “Open”, and the waste sensor
will be enabled to report before the waste container is full; when you drain the waste directly
without using a waste container, CLICK “Close”, and the waste sensor will be disabled. The
default setting is “Open”.
To enable the blood sensor, CLICK “Open”, and to disable the blood sensor, CLICK “Close”.
Once enabled, the blood sensor will detect whether sufficient blood is aspirated and warn
operators about insufficient aspiration. The default setting is “Close”.
NOTE
For bi-directional LIS mode, the “Entry of next sample ID” is set to “Manual
entry” and cannot be changed.
Disable the blood sensor when running samples with extreme low
concentrations, for example, samples of dialysis patients.
To exit the “Assistant” screen, CLICK any other button at the left of the screen or any button at
the bottom. A dialog box shown in Figure 5-7 will pop up.
5-6
Customizing the Analyzer Software
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Reagents
NOTE
Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.
You can set the expiration date of the diluent, LEO (I) lyse, LEO (II) lyse, LBA lyse and LH lyse
at the “Reagent” screen.
At the “Setup” screen, CLICK the “Reagent” button to enter the screen shown in Figure 5-8.
5-7
Customizing the Analyzer Software
CLICK the box of the desired reagent and enter the expiration date.
If the expiration date you entered is out of the range of 2000 – 2036, a dialog box shown in
Figure 5-9 will pop up when you close the date setting dialog box. CLICK “Yes” to abort the
changes and switch to the corresponding screen. CLICK “No” button to reenter the valid date.
If an external barcode scanner is connected, you can CLICK the “Barcode scanner” check
box shown in Figure 5-10 to use it. Scan the barcode with the external barcode scanner. If you
hear a beep, it means the entry is finished. The expiration date of reagents will appear in the
corresponding boxes.
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Customizing the Analyzer Software
NOTE
For any reagent, the entered expiration date should be either the expiration
date printed on the labeling or the open-container expiration date,
whichever is earlier. The open-container expiration date is calculated as
follows: the date that container is opened + the open-container stability
days.
To exit the “Reagent” screen, CLICK any other button at the left of the screen or any button at
the bottom. If the setting is valid, a dialog box shown in Figure 5-11 will pop up when you exit
the screen.
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Customizing the Analyzer Software
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen. If the expiration date is set before
the current system date, when you exit the screen, a prompt of reagent expiry will pop up and
you need to change a new container of reagent.
You can view and change only your own information at this screen.
Changing information
CLICK the “Modify” button and the “Modify information” screen shown in Figure 5-13 will
pop up.
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Customizing the Analyzer Software
Enter the log-in password of the current user in the “Old password” box and CLICK “Ok”. If
the password entered does not consist with the password of the current user, a dialog box
shown in Figure 5-14 will pop up, prompting “Invalid password!”. CLICK “Ok” to close the
dialog box and reenter the password.
If the password entered is correct, the screen will be shown as Figure 5-15.
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Customizing the Analyzer Software
Enter the new information (the identity or position of the operator or nothing here ), user name
and password of the current operator, CLICK the “Ok” button to save the changes and return
to the “User” screen. CLICK the “Cancel” button to abort the changes and return to the “User”
screen.
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Customizing the Analyzer Software
5.3 Administrator
When you log in as an administrator, the “Setup” screen will be shown as Figure 5-16.
5.3.1 Settings
Ref. range
The “Ref. Range” screen is where you view and set the high and low limits for your patients.
The analyzer flags any parameter value above (H) or below (L) these limits.
This analyzer divides patients into 5 demographic groups: General, Man, Woman, Child and
Neonate. You can also customize another 5 groups. The default setting is “General”. The
recommended limits are provided for your reference only. To avoid misleading parameter flags,
be sure to set the patient limits according to the characteristics of your local population.
At the “Setup” screen, CLICK the “Ref. Range” button to enter the screen shown in Figure
5-17.
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Customizing the Analyzer Software
The default expected results of each parameter are displayed on the screen. You can use the
arrow buttons to browse. At the right side of the screen, there are General, Man, Woman, Child,
Neonate groups and 5 customized groups.
1. At the “Ref. Range” screen, CLICK the corresponding radio button of the “General”,
“Man”, “Woman”, “Child”, “Neonate” or the customized group to select the desired group.
4. If you want to resume the factory default after the changing, see Heading 10.6 Using the
“Initialization” Program (in the Administrator Level) for details.
To exit the “Ref. Range” screen, CLICK any other button at the left of the screen or any button
at the bottom. If the data entered is invalid, a dialog box shown in Figure 5-18 will pop up,
prompting “Invalid input, exit?”.
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Customizing the Analyzer Software
CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” button
to reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-19 will pop up when you exit the
screen.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Ref. units
See Table 5-1 for the available units for every parameter groups. You can choose the desired
unit.
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Customizing the Analyzer Software
**.** /pL /
HGB *** g/L Default
**.* g/dL /
**.* mmol/L /
At the “Setup” screen, CLICK the “Ref. unit” button to enter the screen shown in Figure 5-20.
5-16
Customizing the Analyzer Software
At the screen, parameters sharing the same unit are in one group, with the first parameter
black and the others gray. Units available for the current group are shown at the right side of
the screen.
Note: Since the unit of MCH varies with the unit of MCHC and HGB, you cannot change the
unit of MCH.
1. At the “Ref. unit” screen, CLICK the ref. unit you want to set.
2. CLICK the radio button of the desired unit at the right side of the screen to select a new
unit.
To exit the “Ref. unit” screen, CLICK any other button at the left of the screen or any button at
the bottom. A dialog box shown in Figure 5-21 will pop up.
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Customizing the Analyzer Software
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Print
This analyzer supports laser printers (HP), jet printers (color/black and white, HP) and impact
printers (EPSON). You can select the print format and set the print title at the “Print” screen.
NOTE
If the impact printer is connected when the analyzer is on, you need to
restart the analyzer to use the printer.
At the “Setup” screen, CLICK the “Print” button to enter the screen shown in Figure 5-22.
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Customizing the Analyzer Software
The analyzer provides four print formats in the pull-down list: all paras with graphs, full page;
all paras without graphs, half page; all paras compact, half page; CBC with histograms, half
page. The default format is "All paras with graphs, full page".
CLICK the “Custom Format” button to enter the "Custom Print Format" dialog box shown in
Figure 5-23. In this dialog box, you can import or delete custom print formats.
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Customizing the Analyzer Software
1. New
You can import the print formats stored in a USB drive to the analyzer.
CLICK the “New” button, and the dialog box shown in Figure 5-24 will pop up.
All the format files stored in the USB drive are listed in the dialog box. Select the file you want
to import, and enter the name for this format in the "Format Name" box. Then CLICK “Ok”. If
the format name you entered is valid, the selected format file will be imported and displayed in
the pull-down list of the "Print Format" box. If the import failed, a dialog box of "File import
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Customizing the Analyzer Software
2. Delete
You can delete a selected custom print format using the "Delete" button.
3. Rename
Select the custom print format you want to rename, and CLICK the “Rename” button. A dialog
box shown in Figure 5-25 will pop up. Enter a new name in the "Format Name" box and
CLICK “Ok”.
NOTE
Be sure to check the printout if the print format is changed or a new printing
title is entered.
You can select the desired paper size in the pull-down list.
If you want multiple copies of the patient report to be printed, you can enter the desired number
(1 - 9) into the “Copies” field. The default number is 1.
NOTE
This option applies to patient reports only.
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Customizing the Analyzer Software
You can select the desired identification method for the printer from the “Printer” pull-dwon list.
Select “Auto Identification” to identify the printer automatically; select “PCL6” to drive the
printer based on PCL6 protocol.
Print flags
You can select whether to print out the flags in the report.
Activate this function to print reports with flags.
Deactivate this function to print reports without flags.
CLICK the “Print flags” check box to activate it. CLICK the check box again to deactivate it.
You can select whether to print out the suspect flags in the report.
Activate this function to print reports with suspect flags. (“R”)
Deactivate this function to print reports without suspect flags. (“R”)
CLICK the “Print suspect flags” check box to activate it. CLICK the check box again to
deactivate it.
You can select whether to print out the flags for edited results in the report.
Activate this function to print reports with flags for edited results. (“E” or "e")
Deactivate this function to print reports without flags for edited results. (“E” or "e")
CLICK the “Print Flags for Edited Results” check box to activate it. CLICK the check box
again to deactivate it.
You can select whether to print out the ref. range flags in the report.
Activate this function to print reports with ref. range flags (“H” or “L”).
Deactivate this function to print reports without ref. range flags (“H” or “L”).
CLICK the “Print ref. range flags” check box to activate it. CLICK the check box again to
deactivate it.
Auto Print
If the auto-print function is activated, the analyzer can automatically print the analysis results
when the results are shown at the “Count” screen.
CLICK the “Auto Print” check box to activate the auto-print function. CLICK the check box
again to deactivate it.
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Customizing the Analyzer Software
You can select whether to print out the ref. range in the report.
Activate this function to print reports with ref. ranges.
Deactivate this function to print reports without ref. ranges.
CLICK the “Print ref. range” check box to activate it. CLICK the check box again to deactivate
it.
You can select whether to print out the time in the QC graph.
Activate this function to print QC graphs with time information.
Deactivate this function to print QC graphs with time information.
CLICK the “Print QC Graph Time” check box to activate it. CLICK the check box again to
deactivate it.
NOTE
If “Print ref. range” is selected, then the “Print ref. range flags” will be
selected by default and unavailable for you to edit. The ref. range and ref.
range flags (“H” or “L”) will be printed in the report together.
If you want to deselect “Print ref. range flags” when “Print ref. range” is
selected (i.e. print the report with ref. ranges but without ref. range flags),
please contact Mindray customer service department or your local
distributor.
If “Print ref. range” is not selected (i.e. print the report without ref. ranges),
then you can select whether to print the ref. range flags (“H” or “L”) in the
report at will.
To exit the “Print” screen, CLICK any other button at the left of the screen or any button at the
bottom. A dialog box shown in Figure 5-26 will pop up.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
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Customizing the Analyzer Software
Transmission
You can set the IP address and DNS address at the “Com.” screen.
At the “Setup” screen, CLICK the “Com.” button to enter the screen shown in Figure 5-27.
Enter the legal addresses in the “IP address(I)”, “Subnet mask(U)” and “Default gateway(D)”
boxes respectively.
Auto-communication
If the auto-communication function is on, the analyzer can automatically communicate the
analysis results when the results are shown at the “Count” screen.
CLICK “On” to activate the auto communication function; CLICK “Off” to deactivate it.
MAC address
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Customizing the Analyzer Software
blood mode should be selected by the operator on the analyzer; Click the “Bi-directional LIS”,
then the measurement mode, as well as the sampling and blood mode will be obtained by
inquiring the LIS system.
NOTE
Be sure that the 10Mbps full duplex mode or auto-detecting function is
supported by the computer used for the LIS communication.
To exit the “Com.” screen, CLICK any other button at the left of the screen or any button at the
bottom. If the setting is invalid, a dialog box as follows will pop up.
CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.
If the setting is valid, a dialog box shown in Figure 5-29 will pop up.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Code
To facilitate the operation, you can set some simple codes for frequently used names of
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Customizing the Analyzer Software
departments or senders. In this case, when editing sample information at the “Count” and
“Review” screen, you can simply enter the corresponding code for the department or sender.
At the “Setup” screen, CLICK the “Code” button to enter the screen shown in Figure 5-30.
The created code and the name of the department or sender will be displayed at the screen,
10 codes a screen. If more than 10 codes are created, use the arrow buttons to view the rest
codes.
CLICK the “Dept.” or “Sender” radio button. If you have selected the “Dept”, CLICK the “New”
button and a dialog box will pop up, as shown in Figure 5-31. Enter the desired information in
the “Code” and “Name” box.
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Customizing the Analyzer Software
If you have selected the “Sender”, CLICK the “New” button and a dialog box will pop up, as
shown in Figure 5-32. Enter the desired information in the “Code” and “Name” box.
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Customizing the Analyzer Software
CLICK the “Ok” button to save the changes and return to the “Setup” screen. CLICK the
“Cancel” button to abort the changes and switch to the “Setup” screen.
CLICK the “Dept.” or “Sender” radio button. CLICK the code you want to change and CLICK
the “Edit” button. A dialog box shown in Figure 5-33 will pop up.
Enter the new information in the corresponding box. CLICK the “Ok” button to save the
change and close the dialog box. CLICK the “Cancel” button to abort the change and close
the dialog box.
CLICK the “Dept.” or “Sender” radio button. CLICK the code you want to delete and CLICK
the “Delete” button. A dialog box shown in Figure 5-34 will pop up.
CLICK “Ok” to confirm the deletion and close the dialog box. CLICK “Cancel” to abort the
deletion and close the dialog box.
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Customizing the Analyzer Software
NOTE
You can delete only one piece of the code information each time.
Auto-protect
Entering the “Auto-protect” screen
At the “Setup” screen, CLICK the “Auto-protect” button to enter the screen shown in Figure
5-35.
You can set here when to start the auto-protect procedure after the relevant fluidic operation
stops. Enter the desired time ranging from 2 to 30 minutes into the “Standby interval” box.
“Start at”: enter the time when you want the fluidics probe cleanser maintenance to start (valid
input range: [0:00,23:59]). The analyzer will prompt the operator to perform the fluidics probe
cleanser maintenance at the configured time when it has been running for more than 24 hours.
“Total runs”: the number of runs performed since it is cleared last time.
“Runs threshold”: when the threshold is reached, the analyzer will automatically perform
special cleaning in the shutdown process and clear the "Total runs".
5-29
Customizing the Analyzer Software
To exit the “Auto-protect” screen, CLICK any other button at the left of the screen or any
button at the bottom. If the data entered are out of the valid range, a dialog box shown in
Figure 5-36 will pop up.
CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-37 will pop up when you exit the
screen.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Autoloader (optional)
Entering the “Autoloader” screen
At the “Setup” screen, CLICK the “Autoloader” button to enter the screen shown in Figure
5-38.
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Customizing the Analyzer Software
You can set conditions to stop the autoloader at the “Autoloader” screen.
NOTE
To avoid personal injury and analyzer damage, setting the autoloader stop
conditions is recommended.
5-31
Customizing the Analyzer Software
If this condition is activated, the analyzer will stop autoloading once the measurement mode
can not be obtained by inquiring the LIS system.
In the autoloading mode without using the built-in barcode scanner, you can select the desired
ID setup mode for the empty tube position detected.
If you CLICK “keeps the same”, in case of empty tube position detected, the next sample ID
keeps the same.
If you CLICK “increases automatically”, in case of empty tube position detected, the next
sample ID increases automatically.
When running samples in autoloading mode without the built-in barcode scanner, you can
match the sample results with the worklist with uncontinuous sample IDs by setting here.
Click “Yes” to activate the function that the sample results will be matched with the worklist per
tube position.
Click ”No” to deactivate the function.
You can select whether the summary is prompted after autoloading is finished.
CLICK “On” to prompt the summary every time the autoloading is finished.
To exit the “Autoloader” screen, CLICK any other button at the left of the screen or any button
at the bottom. A dialog box shown in Figure 5-39 will pop up.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
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Customizing the Analyzer Software
Barcode (optional)
You can set the barcode symbologies at the “Barcode” screen.
This analyzer accepts 6 barcode symbologies: CODE 39, CODE 93, CODEBAR, CODE 128,
UPC/EAN and ITF (cross 25 code).
At the “Setup” screen, CLICK the “Barcode” button to enter the screen shown in Figure 5-40.
CLICK the check box of the desired symbology and enter the number of digits in the “digits”
box. The length of the first 4 symbologies can be 1 to 15 while the length of the ITF can set to
be any even numbers from 2 to 14. You cannot set the character length of the UPC/EAN
symbology, since it has a fixed length of 8 or 13 characters.
If “Unlimited number of digits” is selected, the “Digits” box of corresponding symbology
cannot be edited (which supports any length ranging from 1 to 15 digits).
NOTE
Be sure that the symbology and the character length set match the actual
bar-code in use, and it is suggested not select the symbology not used on
site, which may cause misreading of barcodes.
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Customizing the Analyzer Software
It is suggested not select more than one symbology and the “Unlimited
number of digits” box at the same time, which may cause misreading of
barcodes.
To exit the “Barcode” screen, CLICK any other button at the left of the screen or any button at
the bottom. If the data entered are out of the valid range, a dialog box shown in Figure 5-41 will
pop up.
CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-42 will pop up when you exit the
screen.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
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Customizing the Analyzer Software
At the “Setup” screen, CLICK the “RBC count time” button to enter the screen shown in
Figure 5-43.
To exit the “RBC count time” screen, CLICK any other button at the left of the screen or any
button at the bottom. If the data entered are out of the valid range, a dialog box shown in
Figure 5-44 will pop up, prompting “Invalid input, exit?”.
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Customizing the Analyzer Software
CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” button
to reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-45 will pop up when you exit the
screen.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Gain
You can adjust each digital pot at the “Gain” screen. It is not recommended to adjust gains
frequently.
At the “Setup” screen, CLICK the “Gain” button to enter the screen shown in Figure 5-46.
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Customizing the Analyzer Software
You can adjust the HGB blank voltage by adjusting the HGB gain. Normally the HGB blank
voltage should be within 2.0 – 2.4V (2.28V is recommended). Follow the instruction below to
adjust it.
At the “Gain” screen, CLICK the current value of the “HGB” and enter the new value so that
the HGB blank voltage falls between 2.0 – 2.4V.
To exit the “Gain” screen, CLICK any other button at the left of the screen or any button at the
bottom. If the data entered are out of the valid range, a dialog box shown in Figure 5-47 will
pop up, prompting “Invalid input, exit?”.
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Customizing the Analyzer Software
CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-48 will pop up when you exit the
screen.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Input options
Entering the “Input options” screen
At the “Setup” screen, CLICK the “Input options” button to enter the screen shown in Figure
5-49.
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Customizing the Analyzer Software
You can set the input language for the pop-up keyboard at the “Input options” screen.
CLICK the desired language from the “All keyboard layouts” box, and then CLICK the “Add”
button to add the selected language to the “Available keyboard layouts”.
CLICK the language from the “Available keyboard layouts” box, and then CLICK the
“Delete” button to delete the selected language from the “Available keyboard layouts”.
To exit the “Input options” screen, CLICK any other button at the left of the screen or any
button at the bottom to switch to the corresponding screen.
Reexam rules
Entering the “Reexam Rules” screen
At the “Setup” screen, CLICK the “Reexam Rules” button to enter the screen shown in Figure
5-50.
The "Use Default Rules" option is selected by default, and all the default rules (shown in Table
5-2) are listed at the screen. CLICK the check box in the "Apply" column to select the
corresponding rule and CLICK again to deselect it. All the rules are not selected by default. If
you changed the settings at the screen, a dialog box of whether you want to save the changes
will pop up when you exit the screen.
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Customizing the Analyzer Software
No. Rule Name Rule Description Gender Age (L) Age (H)
1 Rule 1 ([WBC]=*) OR ([RBC]=*) OR
([HGB]=*) OR ([PLT]=*)
2 Rule 2 ([WBC]<3.0) OR ([WBC]>30)
3 Rule 3 [RBC]>8.2
4 Rule 4 ([PLT] <80) OR ([PLT]>1000)
5 Rule 5 ([HGB]<70) OR ([HGB]>180)
6 Rule 6 [MCV]<75
7 Rule 7 [MCV]>105 12 999
8 Rule 8 [MCHC]>380
9 Rule 9 ([MCHC]<300) AND ([MCV]>80)
10 Rule 10 [RDW-CV]>22
11 Rule 11 ([Neu#]=*) OR ([Lym#]=*) OR
([Mon#]=*) OR ([Eos#]=*) OR
([Bas#]=*)
12 Rule 12 ([Neu#]<1.0) OR ([Neu#]>20.0
13 Rule 13 [Lym#]>5.0 12 999
14 Rule 14 [Lym#]>7.0 0 12
15 Rule 15 [Mon#]>1.5 12 999
16 Rule 16 [Mon#]>3.0 0 12
17 Rule 17 [Eos#]>2.0
18 Rule 18 [Bas#]>0.5
19 Rule 19 [WBC Abn Scattergram]
20 Rule 20 [Immature Cell?]
21 Rule 21 [Left Shift?]
22 Rule 22 [Abn./Atypical Lym?]
23 Rule 23 [RBC Lyse Resist?]
24 Rule 24 [WBC Abn.?]
25 Rule 25 [RBC Abn. Distribution]
26 Rule 26 [Anisocytosis]
27 Rule 27 [Diamorphologic]
28 Rule 28 [RBC or HGB Abn.?]
29 Rule 29 [HGB Abn./Interfere?]
30 Rule 30 [PLT Abn Distribution]
31 Rule 31 [PLT Clump?]
You can import custom reexam rules stored in a USB drive to the analyzer.
Select "Use Custom Rules". Then CLICK the "Import" button, and the dialog box shown in
Figure 5-51 will pop up.
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Customizing the Analyzer Software
In the dialog box, select the reexame rule file you want to import, and then CLICK "Ok".
If the selected file is imported successfully, the current custom rules will be deleted, and the
newly imported rules will be saved as the custom rules all of which will be selected; if the
import failed, a dialog box will pop up, prompting "Import error!"
To exit the “Reexam Rules” screen, CLICK any other button at the left of the screen or any
button at the bottom. A dialog box shown in Figure 5-52 will pop up.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
Flag Rules
Entering the “Flag Rules” screen
At the “Setup” screen, CLICK the “Flag Rules” button to enter the screen shown in the
following figure.
5-41
Customizing the Analyzer Software
You can set up the flag rules of WBC, RBC and PLT parameters. See the following list for the
flag rules:
5-42
Customizing the Analyzer Software
Select the flag message to be edited; an edit box will appear at the bottom of the screen, enter
the number to be set up and click the “Modify” button, the new rule will be displayed in the list
of flag messages.
NOTE
When setting flag rules, the lower limit of the flag message indicating the
increase of cells (e.g. Leucocytosis, Neutrophilia, Lymphocytosis and
Thrombocytosis) shall not be lower than the upper limit of the flag message
indicating the decrease of cells (e.g. Leucopenia, Neutropenia,
Lymphopenia, and Thrombocytopenia).
To exit the “Flag Rules” screen, CLICK any other button at the left of the screen or any button
at the bottom. A dialog box shown in Figure 5-52 will pop up.
CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.
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Customizing the Analyzer Software
This screen shows the information of all administrators and common users. The default user is
the current user. At the “User” screen, the operator can not only change his/her own
information, but also can create, delete and change information of other users.
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Customizing the Analyzer Software
CLICK the “User” or “Administrator” radio button to add the desired user.
Enter the desired information in each box. CLICK the “Ok” button to save the changes and
close the dialog box. The new user information will be displayed at the “User” screen. CLICK
the “Cancel” button to close the dialog box without saving the changes.
NOTE
Do not repeat any name when you create users.
Deleting a user
CLICK the user you want to delete, and then CLICK the “Delete” button at the bottom of the
screen. A dialog box shown in Figure 5-57 will pop up.
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Customizing the Analyzer Software
CLICK “Yes” to confirm the deletion and close the dialog box. CLICK “No” to abort the deletion
and close the dialog box.
NOTE
You can delete only one piece of user information each time.
Changing information
CLICK the user you want to change, and then CLICK the “Modify” button. The “Modify
information” screen shown in Figure 5-58 will pop up.
Enter the log-in password of the current user in the “Old password” box and CLICK “Ok”. If
the password entered does not consist with the password of the current user, a dialog box
shown in Figure 5-59 will pop up, prompting “Invalid password!”. CLICK “Ok” to close the
dialog box and reenter the password.
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Customizing the Analyzer Software
If the password entered is correct, the screen will be shown as Figure 5-60.
Enter the new information (you can enter the identity or position of the operator or nothing
here), user name and password of the current operator, CLICK the “Ok“ button to save the
changes and close the dialog box. CLICK the “Cancel” button to abort the changes and close
the dialog box. Note that when changing the information of other users, you can only change
the operators’ name and information, the user names and passwords cannot be changed.
5-47
6 Operating Your Analyzer
6.1 Introduction
This chapter provides step-by-step procedures for operating your analyzer on a daily basis. A
flow chart presenting the common daily operating process is shown below.
Initial Checks
Power on
Daily Quality
Control
Sample
Collection and
Handling
Run Samples
Shutdown
6-1
Operating Your Analyzer
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
NOTE
You should only use the Mindray-specified reagents. Store and use the
reagents as instructed by instructions for use of the reagents.
Check and make sure the reagents, waste and pneumatic unit tubes are properly connected
and not bent.
Check and make sure the power cords of the analyzer and the pneumatic unit are properly
plugged into the power outlet.
6-2
Operating Your Analyzer
Check and make sure the power cord of the printer is properly plugged into power outlet.
Check and make sure the printer is properly connected to the analyzer.
Check and make sure the scanner, keyboard or mouse is properly connected to the analyzer.
6-3
Operating Your Analyzer
6.3 Power-on
Place the power switch at the back of the pneumatic unit in the ON position (I), and then place
the power switch at the left side of the analyzer in the ON position (I). The power indicator light
will be on. Press the power button to turn on the analyzer. The power indicator light will turn
from orange to green. The analyzer will sequentially do the self-test and initialize the systems
and the whole process lasts 4 to 12 minutes. Time needed for initializing the fluidic systems
depends on how the analyzer was previously shut down. After the initialization process, the
system will enter the “Main” screen and the login dialog box, shown in Figure 6-1 will pop up.
NOTE
The bottom right of the Login dialog box is the button displaying the current
input language (default: English) of the pop-up keyboard. You can CLICK it
to switch to other language.
Enter the current user name and the password respectively into the “User Name” box and the
“Password” box. CLICK the “Ok” button and the user level prompt will pop up. CLICK the
“Ok” button to enter the “Main” screen shown in Figure 6-2.
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Operating Your Analyzer
NOTE
Since the pneumatic unit is controlled by the analyzer, the power switch of
the pneumatic unit can be kept in the ON position (I).
The system opens different function for the user according to the user level.
The user level depends on the user name and the password when the user
logs in.
6-5
Operating Your Analyzer
Before running any samples, run the controls. See Chapter 8 Using the QC Programs for
details.
6-6
Operating Your Analyzer
At the “Main” screen, CLICK the “Count” icon to enter the “Count” screen shown in Figure
6-3.
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
According to different functions, the “Count” screen can be divided into several areas as
follows.
Title area
The Title area displays the title of the current screen, which, in case of Figure 6-3, is “Count”.
6-7
Operating Your Analyzer
CLICK it and the help information of the “Count” screen will appear.
When error(s) is reported, the Error message area displays error messages one by one,
alternating every two seconds. The severity levels are discriminated from high to low by 5
background colors: red, orange, yellow, green and blue. CLICK it to display the
troubleshooting information.
Status area
1. Analysis status
The Analysis status area shows three statuses in different icons: red icon for waiting, green
icon for ready and flickering green icon for running.
NOTE
If a STAT sample is to be run, yellow icon represents ready and flickering
yellow icon represents running instead.
In the open-vial mode, the flickering yellow icon indicates that the analyzer
is ready to aspirate the next sample.
Waiting: it means the analyzer is not ready for the next run yet.
Ready: it means this analyzer is ready and you can proceed to analyze the next sample.
Running: it means this analyzer is analyzing a sample.
2. Print status
3. Transmission status
Icons are used to display the on/off status of the X-B analysis, gray icon for off and color icon
6-8
Operating Your Analyzer
for on.
Icon is used to display the current input language of the pop-up keyboard and you can switch
to other language by clicking it.
EN English-US CN Chinese-CN
FR French DE German
IT Italian ES Spanish
RU Russian PT Portuguese
TR Turkish CZ Czech
PL Polish RO Romanian
GR Greek
NOTE
Please select the desired input language properly. Improper input language
may lead to confused screen display.
6. System time
It displays the analysis result of the current sample (including histograms and scattergrams,
etc.).
Button area
CLICK buttons here and the corresponding screens or dialog boxes will pop up, or the
corresponding functions will be carried out. CLICK the “>>>“ or “<<<“ button to scroll buttons.
It displays the sample information of the current sample and the next sample. In the “Next
sample” area, different colors are used to discriminate 3 operating modes: blue for AL-WB,
green for OV-WB and yellow for OV-PD.
During the startup, the analyzer will automatically do the background check and display the
result in Analysis result area of the “Count” screen. A “Background Abnormal” error will
6-9
Operating Your Analyzer
appear if the result exceeds the normal background. Refer to Appendix B Specifications for
normal background of parameters.
NOTE
Background count indicates the measure of the particle and electrical
interference.
Running sample with the background abnormal error present will lead to
unreliable results.
If any error occurs during the startup, the analyzer will display the error messages in the Error
message area of the screen. You should remove all the errors before running any sample. See
Chapter 11 Troubleshooting Your Analyzer for solutions.
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Operating Your Analyzer
WARNING
Avoid direct contact with blood samples.
CAUTION
Do not re-use disposable products.
NOTE
Be sure to use clean K2EDTA anticoagulant collection tubes, fused silica
glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary
tubes.
CAUTION
Be sure to collect at least 1mL of whole blood sample when running sample
in the open vial sampling mode; at least 2mL of whole blood sample in the
autoloading mode.
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Operating Your Analyzer
NOTE
For the whole blood samples to be used for WBC differential, you shall store
them at the room temperature and run them within 8 hours after collection.
Be sure to mix any sample that has been prepared for a while before running
it.
1. At the “Count” screen, CLICK the “Mode” button and the “Work mode” dialog box shown
in Figure 6-4 will pop up.
2. In the “Work mode” dialog box, CLICK the “OV-PD” radio button.
3. CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.
4. ENTER the sample ID in the “ID” box. If you have the bar-code scanner installed, you can
simply scan the sample ID into the analyzer.
5. CLICK the “Ok” button to save the change and return to the “Count” screen.
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Operating Your Analyzer
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
The default ID of the sample to be run in the “OV” mode is determined by the
setup of the Entry of next sample ID. See Section 5.2.1 Settings for the setup
method.
In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 15 parameters, 2 histograms
and 1 scattergram. In the “CBC+5DIFF” mode, the analyzer counts blood
cells and 5-part differentiates WBCs; the results include 25 parameters, 2
histograms, 2 scattergrams and 4 RUO parameters.
WBC differential results obtained in the predilute mode are for reference
only.
6. CLICK the “Diluent” button at the “Count” screen, and a dialog box will pop up to prompt
that the analyzer is preparing for adding diluent. After the preparation, the dialog box will
close automatically and the other dialog box shown in Figure 6-5 will pop up.
7. Present a clean centrifugal tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 6-6 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 120μL of diluent (the dispensing volume is controlled by the analyzer) into
the tube. The dispensing progress will be displayed on the screen.
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Operating Your Analyzer
8. When you hear the beep, it means the dispensing is finished. Remove the centrifugal tube.
9. Add 40μL of capillary blood to the diluent, close the tube cap and shake the tube to mix the
sample.
10. After the prediluted sample is prepared, CLICK the “Ok” button to clean the sample probe.
The cleaning progress will be displayed on the screen. After the cleaning is finished, the
dialog box closes automatically.
NOTE
You can also aspirate 120μL of diluent by pipette into the tube.
After mixing the capillary sample with the diluent, be sure to wait 3 minutes
before running the sample.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running
it.
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Operating Your Analyzer
1. CLICK the “OV-WB” or the “OV-PD” radio button in the “Work mode” dialog box to select
the desired work mode.
2. CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.
3. ENTER the sample ID of the next sample into the “ID” box.
4. CLICK the “Ok” button to save the changes and return to the “Count” screen.
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Operating Your Analyzer
NOTE
For bi-directional LIS mode, the measurement mode, as well as the sampling
and blood mode will be obtained by inquiring the LIS system (the
measurement mode must be obtained by inquiring the LIS system, while the
sampling and blood mode can be absent in the LIS system), so you don’t
need to set the “CBC” or “CBC+5DIFF” mode. You can set the sampling and
blood mode, however, if the mode obtained from LIS is different from the
current mode, a dialog box of “Error! Keep LIS and analyzer in the same
mode!” will prompt when you run the sample.
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
The default ID of the sample to be run in the “OV” mode is determined by the
setup of the Entry of next sample ID. See Section 5.2.1 Settings for the setup
method.
In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 15 parameters, 2 histograms
and 1 scattergram. In the “CBC+5DIFF” mode, the analyzer counts blood
cells and 5-part differentiates WBCs; the results include 25 parameters, 2
histograms, 2 scattergrams and 4 RUO parameters.
NOTE
If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.
If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.
At the “Count” screen, CLICK the “Work list” button and the dialog box shown in Figure 6-8
will pop up. Enter the work list information in the box for the next sample.
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Operating Your Analyzer
NOTE
For bi-directional LIS mode, only the sampling mode and blood mode will be
displayed in the “Current” field, and you don’t need to set the “CBC” or
“CBC+5DIFF” measurement mode.
You can edit the “Checker” box at the review screen only after the analysis
is finished.
The predefined operating mode and sample ID are default values in the
“Work list”. Modify them as instructed if necessary.
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
The default ID of the sample to be run in the “OV” mode is determined by the
setup of the Entry of next sample ID. See Section 5.2.1 Settings for the setup
method.
6-17
Operating Your Analyzer
CLICK the “WB” or “PD” radio button. CLICK the “CBC” or “CBC+5DIFF” radio button to
select the work mode.
Entering sample ID
Enter the sample ID in the “ID” box. If you have the bar-code scanner installed, you can simply
scan the sample ID into the analyzer.
SELECT the ref. range from the “ref. range” pull-down list for the next sample. Different sets
of ref. range are provided. The analyzer will judge and flag the results out of range according to
the corresponding reference range. See Chapter 5 Customizing the Analyzer Software for
how to set the reference range.
This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. The first way is designed for the adult or pediatric patients no younger than one
year; the second for the infant patients one month to one year; the third for the neonatal
patients no older than 28 days and the fourth for the neonatal no older than 24 hours. You can
choose only one of the four ways to enter the patient age.
SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. Enter the patient
age after “Age”.
Enter the number of the patient’s medical record into the “Chart No.” box.
You can either directly Enter the name of the department/area, from which the sample came,
into the “Dept.” box or SELECT the desired department from the “Dept.” pull-down list (if
there are previously saved departments in the list).
Enter the number of the patient’s bed into the “Bed No.” box.
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Operating Your Analyzer
Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time).
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list).
Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time).
Entering comments
Copy
CLICK the “Copy” button to copy the information of the last sample to the current work list,
except the information of “Current”, “Tester” and “ID”. (“Current” remains unchanged,
“Tester” appears to be the current login user and “ID” increases automatically by 1.)
“Ok” button
When you have finished entering the work list information, CLICK the “Ok” button to save the
changes and return to the “Count” screen. “Switching mode to pre-dilute, please wait...”
will pop up when you switch from other modes to the “OV-PD” mode.
“Cancel” button
If you do not want to save the entered work list information, CLICK the “Cancel” button to
return to the “Count” screen without saving the changes.
For bi-directional LIS mode, the patient information will be obtained by inquiring the LIS system.
If the information received is invalid, the dialog box shown in Figure 6-9 will pop up after the
current count is finished.
6-19
Operating Your Analyzer
WARNING
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
CAUTION
Do not re-use disposable products.
6-20
Operating Your Analyzer
NOTE
Do not open the front cover after the analysis starts.
The sample probe should be kept away from the tube bottom, when the
probe is aspirating sample. Otherwise, the aspirated volume may be
imprecisely.
The probe tip should not contact the sample tube. Otherwise, the blood may
spill.
The default ref. range is “General” if you run a sample immediately after the
operating mode setting. After the analysis, the analyzer will flag, if any,
according to the reference range of “General”.
At the “Count” screen shown in Figure 6-10, do as follows to run whole blood samples.
1. Be sure the “Mode” of the “Next sample” is “OV-WB” and the analysis status icon is
green.
6-21
Operating Your Analyzer
4. The sample probe will automatically aspirate 120μL of sample. When you hear the beep,
remove the sample tube. The analyzer will automatically run the sample.
5. When the analysis is finished, the results will be displayed on the screen. The analyzer will
be ready for the next analysis.
To improve the work efficiency, you can start aspirating the next sample when you hear a beep
and the status icon is flickering yellow during the analysis of the current sample. See the steps
above for how to aspirate samples.
NOTE
During the analysis, CLICK the “Work list” button to enter the information
for the next sample.
If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.
If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.
CLICK the “>>>“ button to scroll to the "RUO Screen" button. CLICK it for
RUO parameters.
After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1, stay the same or be cleared according to the
setup. See Section 5.2.1 Settings for the setup method.
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Operating Your Analyzer
At the “Count” screen shown in Figure 6-11, do as follows to run prediluted samples.
1. Be sure the “Mode” of the “Next sample” is “OV-PD” and the analysis status icon is green.
4. The sample probe will automatically aspirate 120μL of sample. When you hear the beep,
remove the sample tube. The analyzer will automatically run the sample.
5. When the analysis is finished, the result will be displayed on the screen. The analyzer will
be ready for the next analysis.
6-23
Operating Your Analyzer
NOTE
During the analysis, CLICK the “Mode” button or the “Work list” button to
select the operating mode for the next sample.
If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.
If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.
CLICK the “>>>“ button to scroll to the "RUO Screen" button. CLICK it for
RUO parameters.
After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1, stay the same or be cleared according to the
setup. See Section 5.2.1 Settings for the setup method.
Print
CLICK the “Print” button at the bottom of the screen to print the analysis results for the current
sample.
Parameter flags
If parameter is followed by an “H” or “L”, it means the analysis result has exceeded the
upper or lower limit of the reference range, but still within the display range.
If you see *** as opposed to the result, it means the result is either invalid or out of the
display range. If the WBC result of the sample is less than 0.5 109/L or greater than 250
109/L, this analyzer will not perform the differential analysis and all the related
parameter values will be non-numeric (***).
6-24
Operating Your Analyzer
NOTE
The result of the background check will not be flagged on parameters,
abnormal blood cell differential or morphology.
WBC Flag
Abnormal
Flag Meaning Judgment criterion
Leucocytosis High WBC analysis results WBC > 18.0×109/L
Leucopenia Low WBC analysis results WBC < 2.5×109/L
Neutrophilia High neutrophils analysis NEUT# > 11.0×109/L
results
Neutropenia Low neutrophils analysis NEUT# < 1.0×109/L
results
Lymphocytosis High lymphocytes analysis LYMPH# > 4.0×109/L
results
Lymphopenia Low lymphocytes analysis LYMPH# < 0.8×109/L
results
Monocytosis High monocytes analysis MONO# > 1.5×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L
results
Basophilia High basophils analysis BASO# > 0.2×109/L
results
Suspect
Flag Meaning Judgment criterion
Asp. Abn./Abn. Sample? The aspiration may be Results of primary
abnormal, or the sample itself parameters are severely low
may be abnormal simultaneously
WBC Abn. ? WBC numbers of BASO and WBC numbers of BASO and
DIFF channels are DIFF channels are
inconsistent. The sample inconsistent.
may be abnormal, or the
6-25
Operating Your Analyzer
RBC/HGB Flag
Abnormal
Flag Meaning Judgment criterion
RBC Abn. Distribution Abnormal RBC scattergram RBC scattergram is
abnormal.
Anisocytosis Sizes of RBCs are dissimilar RDW-SD>64 or RDW-CV>22
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Erythrocytosis Increased RBCs RBC# > 6.50×1012/L
Anemia Anemia HGB < 90g/L
Hypochromia Hypochromia MCHC < 29.0g/dL
Diamorphologic RBC diamorphologic Two or more peaks in the
distribution RBC histogram.
Suspect
Flag Meaning Judgment criterion
RBC or HGB Abn.? Results of RBC or HGB may Analyzing and comparing
be inaccurate results of HGB and RBC
HGB Abn./Interfere? HGB results may be Calculating and comparing
6-26
Operating Your Analyzer
PLT Flag
Abnormal
Flag Meaning Judgment criterion
Thrombocytosis PLTs increase PLT > 600×109/L
Thrombocytopenia PLTs decrease PLT < 60×109/L
PLT Abn Distribution PLT histogram distribution is PLT histogram is abnormal.
abnormal.
Suspect
Flag Meaning Judgment criterion
PLT Clump? PLT clump may exist. Calculating and comparing
special analysis parameters
Table 6-2 How the flags of Abnormal Blood Cell Differential or Morphology affect
parameter results
OV-WB Prediluted
Cell Differential Flag
CBC CBC+5DIFF CBC CBC+5DIFF
WBC Abn × √ × √
Left Shift? × √ × ×
Immature Cell? × √ × ×
Abn./Atypical Lym? × √ × ×
Leucocytosis √ √ √ √
Leucopenia √ √ √ √
Neutrophilia × √ × ×
Neutropenia × √ × ×
Lymphocytosis × √ × ×
Lymphopenia × √ × ×
6-27
Operating Your Analyzer
Monocytosis × √ × ×
Eosinophilia × √ × ×
Basophilia × √ × ×
HGB Abn./Interfere? √ √ × ×
Anisocytosis √ √ × ×
Microcytosis √ √ √ √
RBC/HGB
Macrocytosis √ √ √ √
Erythrocytosis √ √ √ √
Anemia √ √ √ √
Hypochromia √ √ √ √
Diamorphologic √ √ × ×
PLT Clump? √ √ × ×
Thrombocytosis √ √ √ √
PLT
Thrombocytopenia √ √ √ √
Small PLT √ √ × ×
Parameters Affected
Flag Abnormal Sub-populations
Neu Lym Mon Eos Bas
WBC Abn NEU,LYM *.** *.**
Scattergram
NEU,MON *.** *.**
6-28
Operating Your Analyzer
NOTE
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
Recount
If you want to recount a sample, do as follows:
1. At the “Count” screen, CLICK the “Work list” button and a dialog box shown in Figure
6-12 will pop up.
6-29
Operating Your Analyzer
2. CLICK the “Copy” button to copy the information of the last sample to the current work list,
except the information of “Current”, “Tester” and “ID”. (“Current” remains unchanged,
“Tester” appears to be the current login user and “ID” increases automatically by 1.)
3. CLICK the “Ok” button to rerun the sample as usually as instructed in Section 6.7.3
Running the samples.
Reexam prompt
While analyzing the sample, the analyzer check the sample results against the reexam rule
you set at the "Reexam Rule" to see if the sample needs to be reexamed. If the sample needs
to be reexamed, a prompt of "Reexam" will be displayed at the "Count" screen, as shown in
Figure 6-13.
CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.
6-30
Operating Your Analyzer
NOTE
An autoloader is required in the autoloading analysis.
1. CLICK the “AL-WB” radio button in the “Work mode” dialog box.
2. CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.
3. You can manually enter the ID for the next sample into the “ID” box; or just CLICK the
“Automatically scan sample ID” check box and the ID for the next sample will be entered
automatically. When this check box is selected, the “ID” box will be grayed out.
4. Enter the rack No. and tube No. for the first sample. The rack No. ranges from 1 to 20 and
the tube No. from 1 to 10. If the "Automatically Scan Rack No." is selected, the rack No. box
will be grayed out.
5. CLICK the “Ok” button to save the change and return to the “Count” screen.
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Operating Your Analyzer
NOTE
You can not perform the autoloading analysis if the “Bi-directional LIS”
mode is selected but no barcode scanner is configured.
For bi-directional LIS mode, the measurement mode, as well as the sampling
and blood mode will be obtained by inquiring the LIS system (the
measurement mode must be obtained by inquiring the LIS system, while the
sampling and blood mode can be absent in the LIS system), so you don’t
need to set the “CBC” or “CBC+5DIFF” mode. You can set the sampling and
blood mode, however, if the mode obtained from LIS is different from the
current mode, this sample will be included in “Samples in wrong mode in
LIS” in the “Summary” dialog box popping up after counting (for more about
the “Summary” dialog box, see 6.9.3 Running the samples).
In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 15 parameters, 2 histograms
and 1 scattergram. In the “CBC+5DIFF” mode, the analyzer counts blood
cells and 5-part differentiates WBCs; the results include 25 parameters, 2
histograms, 2 scattergrams and 4 RUO parameters.
The default first rack number is the number of the first detected sample
carrier after the analysis is started.
NOTE
If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.
If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.
6-32
Operating Your Analyzer
At the “Count” screen, CLICK the “Work list” button and a dialog box shown in Figure 6-15
will pop up.
CLICK the “New” button and a dialog box shown in Figure 6-16 will pop up. You can enter the
work list information of the sample to be run into the dialog box.
6-33
Operating Your Analyzer
NOTE
For bi-directional LIS mode, the measurement mode will be obtained by
inquiring the LIS system, so you don’t need to set the “CBC” or
“CBC+5DIFF” mode.
You can edit the “Checker” box at the review screen only after the analysis
is finished.
The “CBC” or “CBC+5DIFF” mode is selected by the operator at the "Work mode" dialog box
and can not be edited in the work list.
Enter the sample ID, rack No. and tube No. of the sample to be run into the “ID”, “Rack” and
“Tube” boxes respectively. The rack No. ranges from 1 to 20 and the tube No. from 1 to 10.
The default “ID” and “Rack - Tube” will automatically increase by 1 when you CLICK the
“New” button.
Example 1: Suppose the current sample “ID” is “1009” and the “Rack - Tube” is “1-9”, save the
entered information and CLICK the “New” button to enter the work list information, you can
see the default “ID” is “1010” and the default “Rack - Tube” is “1-10”.
Example 2: Suppose the current sample “ID” is “1010” and the “Rack - Tube” is “1-10”, save
the entered information and CLICK the “New” button to enter the work list information, you can
see the default “ID” is “1011” and the default “Rack - Tube” is “2-1”.
NOTE
The system sequences the “Rack - Tube” in ascending order. If the “New” or
“Edit” operation is performed, the system will again sequence the No. in the
work list.
Do not enter repeated sample ID, rack No., tube No and measuring mode
simultaneously.
SELECT the ref. range from the “ref. range” pull-down list for the next sample. Different sets
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Operating Your Analyzer
of ref. range are provided. The analyzer will judge and flag the results out of range according to
the corresponding reference range. See Chapter 5 Customizing the Analyzer Software for
how to set the reference range.
This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. The first way is designed for the adult or pediatric patients no younger than one
year; the second for the infant patients one month to one year; the third for the neonatal
patients no older than 28 days and the fourth for the neonatal no older than 24 hours. You can
choose only one of the four ways to enter the patient age.
SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. enter the patient age
after “Age”.
Enter the number of the patient’s medical record into the “Chart No.” box.
You can either directly enter the name of the department/area, from which the sample came,
into the “Dept.” box or SELECT the desired department from the “Dept.” pull-down list (if
there are previously saved departments in the list).
Enter the number of the patient’s bed into the “Bed No.” box.
Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time).
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list).
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Operating Your Analyzer
Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time).
Entering comments
“Ok” button
When you have finished entering the work list information, CLICK the “Ok” button to save the
changes and return to the “Work list” dialog box.
“Cancel” button
If you do not want to save the entered work list information, CLICK the “Cancel” button to
return to the “Work list” dialog box without saving the changes.
You may perform the following functions in the “Work list” screen if necessary.
Edit
You can modify the work list information in the “Ready” or “Error” status. At the “Work list”
screen, CLICK the desired line, and then CLICK the “Edit” button to enter the dialog box to
modify. See the instruction of entering work list information for how to edit.
When you are editing the work list information of a sample in "Ready" status, the status may
change during your editing; if the status is no longer "Ready" (changed into "Analysing",
"Error" or this work list is deleted since the sample analysis has finished) when you CLICK the
“Ok” button, you changes to the work list will not be saved (if the sample analysis has finished,
the work list will be deleted) and a dialog box will pop up, prompting "Editing invalid!"
If the work list currently highlighted is in the "Analysing" status, the “Edit” button will be grayed
out to disable the this function.
NOTE
After the sample information is changed, the status of “Error” will become
“Ready”. You can rerun the corresponding sample.
Copy
If there is saved work list information in the work list, you can enter a great lot of work list
information by copy once. At the “Work list” screen, CLICK the desired line, and then CLICK
the “Copy” button and the copy dialog box shown in Figure 6-17 will pop up. As up to 200
samples can be analyzed at the same batch, the dialog box will prompt you the maximum
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Operating Your Analyzer
Enter the number of record you desire copying in the “Copy record piece No.” box, CLICK
the “Ok” button to confirm the copy and close the dialog box. The copied work list information
will sequentially appear in the work list.
After the copy, the sample ID will automatically increase by 1 from that of the current selected
sample (if the current selected sample ID ends with a character, the sample ID after the copy
will stay the same). The “Rack - Tube” will automatically increase by 1 from that of the last
sample in the work list (the maximum No. of sample carrier is 20 and tube No. 10. When they
have reached the maximum No., the “Rack - Tube” will begin with 1-1.). The measurement
mode, ref. range, age and sex will not change. You can CLICK the “Edit” button to modify the
sample information.
Delete
You can delete the work list information in the “Ready” or “Error” status in the work list. At the
“Work list” screen, CLICK the “Delete” button and the delete dialog box shown in Figure 6-18
will pop up.
CLICK the desired radio button and then CLICK the “Ok” button to confirm the deletion.
If the record of the sample in the "Analysing" mode is included in the records you want to
delete, a dialog box will pop up when the deleting process is finished, prompting "Unable to
delete the record while the sample is being analyzed!".
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Operating Your Analyzer
Print
CLICK the “Print” button at the “Work list” screen to print the information for the current work
list.
Return
CLICK the “Return” button at the “Work list” screen to close the “Work list” dialog box and
return to the “Count” screen.
NOTE
In the autoloading mode, if the bi-directional LIS function is not enabled,
you can only create, copy, delete or edit records, but not allowed to edit the
sample ID, tube No, rack No. or modes of the records that exist before you
start counting in the autoloading mode.
WARNING
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
CAUTION
Do not re-use disposable products.
Be sure the sample ID, rack No., tube No, and measuring mode entered are
completely the same with the information of the sample to be analyzed.
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Operating Your Analyzer
NOTE
Do not open the front cover after the analysis starts.
The default ref. range is “General” if you run a sample immediately after the
operating mode setting. After the analysis, the analyzer will flag, if any,
according to the reference range of “General”.
The measuring modes of the same batch samples are the same.
If neither "Automatically scan sample ID" nor "Automatically Scan Rack No." is selected,
run the sample instructed as follows.
1. Be sure the “Mode” of the “Next sample” is “AL-WB”, neither "Automatically scan
sample ID" nor "Automatically Scan Rack No." is selected, and the analysis status icon
is green.
2. Mark the prepared tubes according to the sample ID, rack No. and tube No. entered. Place
the tubes into the corresponding tube positions.
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Operating Your Analyzer
3. Place racks loading tubes in ascending order on the level of the right tray of the autoloader,
with the back of “MINDRAY” mark on the carrier facing the analyzer.
4. CLICK the “Start Count” button at the “Count” screen. The analyzer will start the analysis
automatically.
5. After every analysis cycle, the results will be displayed on the analysis result area and
saved to the sample database. The record of this sample will disappear from the “Work
list” screen.
6. Every time the autoloading is finished, a dialog box shown in Figure 6-21 will pop up.
If you have selected "Bi-directional LIS" at the communication setup screen, there will be
items related to the LIS communication in the summary, as shown in Figure 6-21.
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Operating Your Analyzer
6-41
Operating Your Analyzer
7. After all samples are analyzed, all the racks come to the left tray of the autoloader.
Remove them safely.
If "Automatically scan sample ID" and/or "Automatically Scan Rack No." is selected, run
the sample instructed as follows.
1. Be sure the “Mode” of the “Next sample” is “AL-WB”, the built-in barcode scanner is
selected and the analysis status icon is green.
2. If "Automatically scan sample ID" and/or "Automatically Scan Rack No." is selected,
place labels on the tubes as instructed in Section 6.9.6 Barcode Labels. Place the tubes
into the corresponding tube positions as shown in Figure 6-23.
3. Load racks sequentially on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the carrier facing the analyzer.
4. CLICK the “Start Count” button at the “Count” screen. The analyzer will start the analysis
automatically.
5. After every analysis cycle, the results will be displayed on the analysis result area and
saved to the sample database. The record of this sample will disappear from the “Work
list” screen.
6. Every time the autoloading is finished, a dialog box shown in Figure 6-23 will pop up.
CLICK “Detail…” buttons to display corresponding details, as shown in Figure 6-24.
7. After all samples are analyzed, all the racks come to the left tray of the autoloader.
Remove them safely.
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Operating Your Analyzer
NOTE
The built-in barcode scanner is requested for autoloading analysis in
“Bi-directional LIS” mode. Therefore, if you select the "AL-WB" mode, the
"Automatically scan sample ID" check box will be selected by default and
cannot be deselected.
During the autoloading process, if the entry rule of next sample ID is set as
“Auto-increment” and the starting sample ID ends with a character, all
sample IDs in the autoloading cycle will stay the same.
You can reedit or delete the information of the sample erroneously analyzed.
If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.
If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.
If the racks for the samples to be run of the same batch exceed the capacity
of the autoloader, you need to timely add the rest racks to the right tray of
the autoloader and take away the racks on the left tray of the autoloader.
If abnormal power failure occurs after the analysis starts, remove the rack(s)
manually, open the front cover to check for fallen test tube and take it out, if
any.
Pause
During the analysis, to make a pause for the current analysis, CLICK the “Pause” button at the
“Count” screen. The system stops the analysis and the “Pause” button turns to the “Continue”
button after the previously analyzing cycle is finished. To continue the analysis, CLICK the
“Continue” button to resume the analysis.
If the analysis pauses for errors, remove the errors first before continuing the analysis. See
Chapter 11 Troubleshooting Your Analyzer for how to remove errors. After the errors are
removed, to continue the analysis, CLICK the “Continue” button and the dialog box shown in
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Operating Your Analyzer
CLICK “Ok” to run samples in the autoloading mode from the current tube position and close
the dialog box. CLICK “Cancel” to close the dialog box and stay in the pause status.
Stop
During the analysis or in the status of the pause, to stop the analysis and eject the current
sample rack, CLICK the “Stop Count” button. After the previously analyzing cycle is finished,
the system stops the analysis and the current sample carrier comes to the left tray of the
autoloader.
STAT
If there is STAT sample requires running first during the analysis, CLICK the “STAT” button at
the “Count” screen and CLICK the “Ok” button on the prompt dialog box. After the previously
analyzing cycle is finished, the analysis stops and the system switches the autoloading mode
to the open vial sampling mode. When the analysis status icon turns to yellow, you can run the
STAT sample in the open vial sampling mode. See 6.7 Open Vial Sampling Analysis for
details. After the analysis is finished, CLICK the “Exit STAT” button at the “Count” screen to
resume the autoloading mode for the rest samples. The sample ID resumes the next sample
ID before the STAT.
Print
CLICK the “Print” button at the “Count” screen to print out the results of the current sample.
CLICK the “Print” button at the “Work list” screen to print out the information of the current
work list.
Parameter flags
If parameter is followed by an “H” or “L”, it means the analysis result has exceeded the
upper or lower limit of the reference range, but still within the display range..
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Operating Your Analyzer
If you see *** as opposed to the result, it means the result is either invalid or out of the
display range. If the WBC result of the sample is less than 0.5 109/L or greater than 250
109/L, this analyzer will not perform the differential analysis and all the related
parameter values will be non-numeric (***).
NOTE
The result of the background check will not be flagged on parameters,
abnormal blood cell differential or morphology.
WBC Flag
Abnormal
Flag Meaning Judgment criterion
Leucocytosis High WBC analysis results WBC > 18.0×109/L
Leucopenia Low WBC analysis results WBC < 2.5×109/L
Neutrophilia High neutrophils analysis NEUT# > 11.0×109/L
results
Neutropenia Low neutrophils analysis NEUT# < 1.0×109/L
results
Lymphocytosis High lymphocytes analysis LYMPH# > 4.0×109/L
results
Lymphopenia Low lymphocytes analysis LYMPH# < 0.8×109/L
results
Monocytosis High monocytes analysis MONO# > 1.5×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L
results
Basophilia High basophils analysis BASO# > 0.2×109/L
results
Suspect
Flag Meaning Judgment criterion
Asp. Abn./Abn. Sample? The aspiration may be Results of primary
abnormal, or the sample itself parameters are severely low
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Operating Your Analyzer
RBC/HGB Flag
Abnormal
Flag Meaning Judgment criterion
RBC Abn. Distribution Abnormal RBC scattergram RBC scattergram is
abnormal.
Anisocytosis Sizes of RBCs are dissimilar RDW-SD>64 or RDW-CV>22
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Erythrocytosis Increased RBCs RBC# > 6.50×1012/L
Anemia Anemia HGB < 90g/L
Hypochromia Hypochromia MCHC < 29.0g/dL
Diamorphologic RBC diamorphologic Two or more peaks in the
distribution RBC histogram.
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Operating Your Analyzer
Suspect
Flag Meaning Judgment criterion
RBC or HGB Abn.? Results of RBC or HGB may Analyzing and comparing
be inaccurate results of HGB and RBC
HGB Abn./Interfere? HGB results may be Calculating and comparing
abnormal, or interference special analysis parameters
may exist
PLT Flag
Abnormal
Flag Meaning Judgment criterion
Thrombocytosis PLTs increase PLT > 600×109/L
Thrombocytopenia PLTs decrease PLT < 60×109/L
PLT Abn Distribution PLT histogram distribution is PLT histogram is abnormal.
abnormal.
Suspect
Flag Meaning Judgment criterion
PLT Clump? PLT clump may exist. Calculating and comparing
special analysis parameters
Table 6-4 How the flags of Abnormal Blood Cell Differential or Morphology
AL-WB
Cell Differential Flag
CBC CBC+5DIFF
WBC Abn × √
Left Shift? × √
Immature Cell? × √
Abn./Atypical Lym? × √
Leucocytosis √ √
Leucopenia √ √
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Operating Your Analyzer
Neutrophilia × √
Neutropenia × √
Lymphocytosis × √
Lymphopenia × √
Monocytosis × √
Eosinophilia × √
Basophilia × √
HGB Abn./Interfere? √ √
Anisocytosis √ √
Microcytosis √ √
RBC/HGB
Macrocytosis √ √
Erythrocytosis √ √
Anemia √ √
Hypochromia √ √
Diamorphologic √ √
PLT Clump? √ √
Thrombocytosis √ √
PLT
Thrombocytopenia √ √
Small PLT √ √
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Operating Your Analyzer
Parameter affected
Flag Abnormal Sub-populations
Neu Lym Mon Eos Bas
NEU,LYM *.** *.**
NEU,MON *.** *.**
NEU,EOS *.** *.**
NEU,BASO *.** *.**
WBC Abn
LYM,MON *.** *.**
Scattergram
LYM,EOS *.** *.**
NEU,MON,EOS *.** *.** *.**
BASO not differentiated *.** *.**
DIFF not differentiated *.** *.** *.** *.** *.**
Remark “*.**” indicates an invalid result
NOTE
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
Reexam prompt
While analyzing the sample, the analyzer check the sample results against the reexam rule
you set at the "Reexam Rule" screen to see whether the sample needs to be reexamed. If the
sample needs to be reexamed, a prompt of "Reexam" will be displayed at the "Count" screen,
as shown in Figure 6-25.
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Operating Your Analyzer
CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.
In the autoloading mode, the system provides a work list shown in Figure 6-26, to assign the
information such as patient name and age. The work list also presents the current analysis
status.
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Operating Your Analyzer
At the “Count” screen, CLICK the “Work list” button to enter the “Work list” screen. Up to 200
sample records can be displayed in the list at this screen. You can find the records added for
samples to be analysed, records automatically generated for the samples being analyzed and
the records of samples with analysis errors. You can use the arrow buttons to review the
sample records.
You can check the current measurement mode and sample information in the “Work list”
screen.
In the "Cur. mode" section, you can see the current measurement modes and whether an
internal barcode scanner is used.
In the "Sample Info" section, you can see the sample ID, patient name, measurement mode,
rack number, tube number, reference range and analysis state, where the "Name" cell can be
blank, the default "Ref. range" is "General", and the "State" can be "Ready”, “Analysing” or
“Error”.
If the sample being analyzed matches a record in the work list, this record will disappear from
the work list after the analysis is completed successfully.
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Operating Your Analyzer
NOTE
For bi-directional LIS mode, the measurement mode will be obtained by
inquiring the LIS system, so you don’t need to set the “CBC” or
“CBC+5DIFF” mode.
When no record in the work list completely meets the detected sample ID,
rack No., tube No. and measuring mode of the sample, the actually detected
information will be written into the work list as the information of the
sample.
At the “Work list” screen, you can perform the following functions:
Return: close the “Work list” screen and return to the “Count” screen.
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Operating Your Analyzer
CAUTION
The following errors may cause misreading of barcodes:
To ensure the correct barcode can be read, you must place labels right on the region as shown
in Figure 6-27, and place the label correctly as shown in Figure 6-28.
NOTE
If several labels are stuck to one tube, or the label is misplaced, peeled or
wrinkled, it may cause autoloading error. To avoid such error, the notes
below shall be followed:
Do not use barcode label which is easily peeled to prevent the label from
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Operating Your Analyzer
peeling.
Ensure that the tube with barcode label can be taken out from and placed
back to the rack easily.
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Operating Your Analyzer
6.9 Auto-Sleep
When the time for which the analyzer is free from fluidic operations reaches that you have set
at the "Auto-protect" screen, a dialog box will pop up, prompting “Preparing to sleep, please
wait...”. After the preparation, the dialog box closes automatically and the analyzer is in the
auto-sleep status. During this condition, you can still perform any other operations other than
relevant fluidic operations.
NOTE
To change the time when to start the auto-sleep, see Heading 5.3.1 Settings
for details.
If it is time for auto-sleep, current operations will pause. When the analyzer
is in the auto-sleep status, you can continue the operations.
To cancel the auto-sleep, press the aspirate key and a dialog box of “Restoring from sleeping,
please wait…” will pop up. After the auto-sleep is canceled, the dialog box will close
automatically.
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Operating Your Analyzer
6.10 Shutdown
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.
NOTE
To ensure stable analyzer performance and accurate analysis results, be
sure to perform the “Shutdown” procedure, maintaining for no less than 2
hours, to shut down the analyzer after it has been running continuously for
24 hours.
CLICK the shutdown button at the “Main” screen and the shutdown dialog box shown in Figure
6-30 will pop up.
CLICK “Yes” to shutdown the analyzer. After the shutdown is finished, the screen will
automatically close.
Place the power switch at the left side of the analyzer to OFF (O) to turn off the analyzer.
Empty the waste container and dispose of the waste properly.
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7 Reviewing Sample Results
7.1 Introduction
The analyzer automatically saves analysis results. Totally 40,000 results can be saved, each of
which including 25 parameters, 4 RUO (Research Use Only) parameters, scattergrams and
histograms.
You can browse sample results either in the table or graph mode.
7-1
Reviewing Sample Results
CLICK the “Review” icon button at the “Main” screen to enter the “Table review” screen of the
sample database, as shown in Figure 7-1.
To browse sample results, SELECT the “Sample database”, “Search database” or “Selected
database” from the “Current” pull-down list. Sample results that have been found or selected
will be saved respectively to the “Search database” or “Selected database”. See Section
7.2.2 Selecting/Deselecting sample results and Section 7.2.3 Search for a particular
sample result(s) for details.
You can review sample results in three databases in the same way. Take “Sample database”
for example, you can review sample results in the table review mode as instructed below.
7-2
Reviewing Sample Results
NOTE
You can select up to 500 samples at a time. If the selected results are more
than 500, the first 500 results selected will be taken.
CLICK at the head of the column of the desired sample result. The selected sample results will
be highlighted and marked with a "*" in the first row, as the sample “4” shown in Figure 7-3.
7-3
Reviewing Sample Results
Once the sample result is deselected, the highlight and mark will be canceled, as the sample
“4” shown in Figure 7-4.
7-4
Reviewing Sample Results
Example 1: To select sample results of positions 1 – 5 in the sample database, follow the
procedure below to do so.
1. At the “Table Review” screen of the sample database, CLICK the “Select” button and a
dialog box shown in Figure 7-5 will pop up.
2. ENTER “1” in the “From” box and “5” in the “To” box.
3. CLICK the “Select” button to save the selected sample results to the selected database,
and enter the “Table Review” screen of the selected database shown in Figure 7-6 to view
the selected results.
7-5
Reviewing Sample Results
You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database. The selected sample results will be
highlighted.
Example 2: To select all sample results in the sample database, follow the procedure below to
do so.
1. At the “Table Review” screen of the sample database, CLICK the “Select” button and a
dialog box shown in Figure 7-7 will pop up.
2. CLICK the “All” button to save all sample results to the selected database, and enter the
7-6
Reviewing Sample Results
“Table Review” screen of the selected database shown in Figure 7-8 to view the selected
results.
3. You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database. All selected sample results will be
highlighted.
1. At the “Table Review” screen of the sample database, CLICK the “Select” button and a
dialog box shown in Figure 7-9 will pop up.
7-7
Reviewing Sample Results
2. ENTER “1” in the “From” box and “5” in the “To” box.
3. CLICK the “Deselect” button to deselect the sample results of positions 1 – 5 in the
sample database, and enter the “Table Review” screen of the selected database. The
selected sample results from 1 to 5 will be cleared, as shown in Figure 7-10.
4. You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database. The deselected sample results will not be
highlighted any longer.
7-8
Reviewing Sample Results
NOTE
In the “Select” dialog box, without entering any number in the “From” box
and the “To” box, you can CLICK the “Deselect” button directly to deselect
all sample results.
After exiting the “Table Review” screen, the sample results of the selected
database will be cleared and the sample results of the sample database will
not be highlighted any longer.
CLICK the check box before the desired “keyword” to select this item; CLICK the check box
again to deselect it.
7-9
Reviewing Sample Results
NOTE
Up to 500 samples can be displayed as searching results at a time. If the
results found are more than 500, the first 500 results found will be taken.
Entering sample ID
CLICK the “ID” button and enter the sample ID in the “ID” box.
CLICK the “Sex” check box, and then CLICK “Male”, “Female” or “Unknown” radio button to
select the patient sex.
CLICK the “Name” check box and enter the patient name in the “Name” box.
CLICK the “Date” check box. You can search sample results in two ways, as shown below.
Example 1: Search for sample results saved during the last 2 days.
CLICK the “Last” button, and SELECT “2” from the “Last” pull-down list.
Example 2: Search sample results saved between Jun. 1st, 2008 and Jul. 1st, 2008.
CLICK the “From” button and CLICK the box behind it, and then enter the starting and ending
date for your search.
CLICK the “Dept.” check box and SELECT the desired department from the “Dept.”
pull-down list.
CLICK the “Bed No.” check box and enter the patient bed number in the “Bed No.” box.
CLICK the “Chart No.” check box and enter the patient chart number in the “Chart No.” box.
Reexam?
CLICK the “Reexam?” check box and select from the "On" and "Off" radio buttons.
7-10
Reviewing Sample Results
CLICK the “Exact” or “Contain” button from the “Matching Type” to search the proper sample
results.
After selecting search conditions, CLICK the “Search” button. The screen will automatically
display the search results, as shown in Figure 7-12.
CLICK the “Ok” button to enter the “Table Review” screen of the search database shown in
Figure 7-13 to view the found sample results.
You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database.
7-11
Reviewing Sample Results
NOTE
Once you leave the “Table Review” screen, the sample results saved in the
search database will be cleared.
Enter the sample result position into the “Go to” box and CLICK the “Ok” button to go to the
desired sample result.
NOTE
To correct erroneous entries, DELETE and ENTER the desired information.
CLICK the “Edit Info.” button and a dialog box shown in Figure 7-15 will pop up.
7-12
Reviewing Sample Results
NOTE
Up to 15 characters may be entered into the ID box as a sample ID. The
sample ID can end with a numeric or a character. Sample ID consisting of
only “0”s will be considered invalid.
Entering Sample ID
Enter the sample ID in the “ID” box. If you have the bar-code scanner installed, you can simply
scan the sample ID into the analyzer.
This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. The first way is designed for the adult or pediatric patients no younger than one
7-13
Reviewing Sample Results
year; the second for the infant patients one month to one year; the third for the neonatal
patients no older than one month and the fourth for the neonatal no older than 24 hours. You
can choose only one of the four ways to enter the patient age.
SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. enter the patient age
per the selected unit.
Enter the number of the patient’s medical record into the “Chart No.” box.
You can either directly enter the name of the department/area, from which the sample came,
into the “Dept.” box or SELECT the desired department from the “Dept.” pull-down list (if
there are previously saved departments in the list).
Enter the number of the patient’s bed into the “Bed No.“ box.
Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time)
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list).
Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time)
SELECT the desired name from the “Checker” pull-down list (if there are previously saved
names in the list). If the name of the checker is unavailable in the list, CLICK the “Sign” button
to the right of the “Checker” box. The login dialog box shown in Figure 7-16 will pop up.
7-14
Reviewing Sample Results
Enter the name and password (administrator level) of the checker respectively into the “User
name” and “Password” boxes. CLICK the “Ok” button to return to the Editing work list
information dialog box. The checker’s name will automatically appear in the “Checker” box.
Entering comments
“Ok” button
When you have finished entering the work list information, CLICK the “Ok” button to save the
changes and return to the “Table Review” screen.
“Cancel” button
If you do not want to save the entered work list information, CLICK the “Cancel” button to
return to the “Table Review” screen without saving the changes.
x i
Mean= i1
n
X Mean
2
SD
i
n 1
SD
CV% 100
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis.
7-15
Reviewing Sample Results
To check the reproducibility of the selected sample results, CLICK the “CV” button to enter the
“Calculate CV” screen shown in Figure 7-17.
NOTE
Samples 3 to 30 can be selected to calculate the reproducibility.
If any selected result contains invalid parameter value (s), the Mean, SD and
CV% of that parameter(s) will also be non-numeric (***).
After browsing, CLICK the “Return” button to close the dialog box and return to the “Table
Review” screen.
After selecting the sample results, CLICK the “Trend” button to enter the “Trend” screen.
Check the trend graph of the selected sample results, as shown in Figure 7-18.
7-16
Reviewing Sample Results
NOTE
Trend graphs of 3 to 500 sample results can be viewed.
If any selected result contains invalid parameter value (s), the Mean, SD and
CV% of that parameter(s) will also be non-numeric (***). The system will
automatically adopt the lower limit, mean value and the upper limit of the
“General” reference range as those in the trend graph. See Chapter 5
Customizing the Analyzer Software for how to set the reference range.
The x-axis represents the number of the sample results selected; the y-axis represents the
analyses results of every parameter.
For every parameter, the three numbers to the left of the graph indicate respectively the
three discriminators, upper limit, mean value and lower limit from top to bottom.
7-17
Reviewing Sample Results
For every parameter,the three numbers to the right of the trend graph are defined and
calculated as follows:
x i
Mean= i1
n
X Mean
2
SD
i
n 1
SD
CV% 100
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis.
Browsing data
As trend graphs and Mean, SD, CV% values of the parameters can not be displayed on the
screens at the same time, you can use the arrow keys to the right of the graphs browse. In
each trend graph, the saved results are sequentially displayed, the latest on the utmost left. If
information cannot be displayed in one screen, use the arrow keys below the graphs to
browse.
If you want to view certain parameters of a sample result, CLICK the corresponding “■” in any
trend graph to connect the “■” in 6 trend graphs. The 6 corresponding parameter results will
be displayed below the corresponding parameter. The position of the current sample result and
the total number of sample results at the “Trend” screen are displayed in the “Pos./Total” box.
The analysis time is displayed in the “Time” box.
1. CLICK the “Edit” button at the “Trend” screen and a dialog box shown in Figure 7-19 will
pop up.
7-18
Reviewing Sample Results
4. CLICK the “Ok” button to confirm the change. You can see the adjusted trend graph and
limits of the desired parameter.
Exit
CLICK the “Return” button to exit the “Trend” screen and return to the “Table Review” screen.
1. CLICK the “Print” button and a dialog box shown in Figure 7-20 will pop up.
2. CLICK the “Table Print” or “Graph Print” radio button to select the print mode.
3. CLICK the “Current Record”, “Selected Record” or “All Records” radio button to select
7-19
Reviewing Sample Results
4. CLICK the “Print” button and a dialog box shown in Figure 7-21 will pop up.
5. CLICK “Yes” to perform the print and close the print dialog box.
7.2.9 Transmission
You can transmit sample results to an external computer (a host) as instructed below.
1. CLICK the “Com.“ button and a dialog box shown in Figure 7-22 will pop up.
2. CLICK the “Selected records” or “All records” button to select the desired sample
results. CLICK the “Start” key and a dialog box will pop up.
7-20
Reviewing Sample Results
To cancel the transmission, CLICK the “Com.” button again and the “Com.” dialog box will
pop up.
4. CLICK the “Stop” button and the transmission will stop after the current transmission is
completed.
NOTE
You can only export data when you log in as an administrator.
7-21
Reviewing Sample Results
If you CLICK the “Reexam(%)” button without selecting any records, the dialog box shown in
Figure 7-26 will pop up.
NOTE
You can only calculate the percentage of samples with reexam prompts
when you log in as an administrator.
To switch to the “Main” screen or the “Count” screen, CLICK the “Main” or “Count” button.
7-22
Reviewing Sample Results
CLICK the “Review” icon at the “Main” screen and then CLICK the “Graph Review” button to
enter the “Graph Review” screen shown in Figure 7-27.
SELECT “Sample database”, “Search database” or “Selected database” from the “Current”
pull-down list to browse desired sample results. Sample results that have been found or
selected will be saved respectively to the “Search database” or “Selected database”. See
Heading 7.2.2 Selecting/Deselecting sample results and Heading 7.2.3 Search for a particular
sample result(s) for details.
You can review sample results in three databases in the same way. Take reviewing “Sample
database” for example, you can review sample results in the graph mode as instructed below.
7-23
Reviewing Sample Results
NOTE
CLICK the "RUO Screen" button to browse the analysis results of RUO
parameters.
7-24
Reviewing Sample Results
NOTE
Up to 15 characters may be entered into the ID box as a sample ID. The
sample ID can end with a numeric or a character. Sample ID consisting of
only “0”s will be considered invalid.
Entering Sample ID
Enter the sample ID in the “ID” box. If you have the bar-code scanner installed, you can simply
scan the sample ID into the analyzer.
This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. The first way is designed for the adult or pediatric patients no younger than one
7-25
Reviewing Sample Results
year; the second for the infant patients one month to one year; the third for the neonatal
patients no older than one month and the fourth for the neonatal no older than 24 hours. You
can choose only one of the four ways to enter the patient age.
SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. enter the patient age
per the selected unit.
Enter the number of the patient’s medical record into the “Chart No.” box.
You can either directly enter the name of the department/area, from which the sample came,
into the “Dept.” box or SELECT the desired department from the “Dept.” pull-down list (if
there are previously saved departments in the list).
Enter the number of the patient’s bed into the “Bed No.” box.
Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time)
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list).
Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time)
SELECT the desired name from the “Checker” pull-down list (if there are previously saved
names in the list). If the name of the checker is unavailable in the list, CLICK the “Sign” button
to the right of the “Checker” box. The login dialog box shown in Figure 7-30 will pop up.
7-26
Reviewing Sample Results
Enter the name and password (administrator level) of the checker respectively into the “User
name” and “Password” boxes. CLICK the “Ok” button to return to the editing work list
information dialog box. The checker’s name will automatically appear in the “checker” box.
Entering comments
“Ok” button
When you have finished entering the work list information, CLICK the “Ok” button to save the
changes and return to the “Graph Review” screen.
“Cancel” button
If you do not want to save the entered work list information, CLICK the “Cancel” button to
return to the “Graph Review” screen without saving the changes.
7-27
Reviewing Sample Results
7-28
Reviewing Sample Results
The analysis results of different parameters are displayed in the edit boxes where you can edit
directly. When you finish your editing, CLICK “Ok” to save your changes and close the dialog
box; or CLICK “Cancel” to close the dialog box without saving the changes.
Use [Tab] or [Shift]+[Tab] to switch to the previous or next edit box.
NOTE
You can only edit the analysis results when you log in as an administrator.
If you edit the result of a parameter, all other related parameters will change
accordingly. The system will display the ref. range flags and suspect flags
based on the edited results.
For samples analyzed in the CBC mode, you can edit the WBC, RBC, HGB,
HCT and PLT results; for samples analyzed in the CBC+5DIFF mode, you
can edit the WBC, Neu%, Lym%, Mon%, Eos%, RBC, HGB, HCT and PLT
results, and you should calculate manually to ensure that the sum of the
differential percentages is 100%.
Once a result is edited, even if it has been checked, the edited result will be
flagged with an "E" after it, and each related result that changed accordingly
will be flagged with an "e".
You can not edit background results. When you click the "Edit Result"
button at the "Graph Review" screen of background results, a dialog box
will pop up, prompting that background results can not be edited.
7-29
Reviewing Sample Results
CLICK “Ok” to restore the results of this sample to the original analysis results and remove the
flags for edited results ("E" and "e"); or CLICK “Cancel” to close the dialog box without
restoring results to original.
For unedited sample results or samples with no original analysis result stored in the analyzer,
when you go to the “Graph Review” screen of the sample, the "Restore" button will be grayed
out and the restoration function is disabled. The edited results will remain flagged if they can
not be restored to the original.
NOTE
You can only restore analysis results when you log in as an administrator.
The analyzer stores the original analysis results of the previous 1000 edited
samples.
To switch to the “Main” screen or the “Count” screen, CLICK the “Main” or “Count” button.
7-30
8 Using the QC Programs
8.1 Introduction
Quality Control (QC) consists of strategies and procedures that measure the precision and
stability of the analyzer. The results imply the reliability of the sample results. QC involves
measuring materials with known, stable characteristics at frequent intervals.
Analysis of the results with statistical methods allows the inference that sample results are
reliable. Mindray recommends you run the QC program daily with low, normal and high level
controls. A new lot of controls should be analyzed in parallel with the current lot prior to their
expiration dates. This may be accomplished by running the new lot of controls twice a day for
five days using any empty QC file. The QC files calculate the mean, standard deviation and
coefficient of variation for each selected parameter. The instrument-calculated means of these
ten runs should be within the expected ranges published by the manufacturer.
NOTE
You should only use the Mindray-specified controls and reagents. Store and
use the controls and reagents as instructed by instructions for use of the
controls and reagents.
8-1
Using the QC Programs
Using the “L-J QC” program, you can provide quality control for up to 25 parameters and other
5 parameters (GRAN-X, GRAN-Y, GRAN-Y(W), WBC/BA-X and WBC/BA-Y) which are
available in the QC program only. The analyzer provides 20 QC files for you to save QC
settings and results. Every QC file can save up to 3 lot numbers, for high, normal and low
controls respectively. The QC file of every lot can save results of up to 310 QC runs. When the
saved QC results have reached 310, the subsequent results will overwrite the oldest.
1. At the “Main” screen, CLICK the “QC” button to enter the screen shown in Figure 8-1.
2. CLICK the “Setting” button in the upper left corner of the screen to enter the screen
shown in Figure 8-2.
8-2
Using the QC Programs
3. Editing QC files
SELECT the desired number from the “File No.” pull-down list, ranging from 1 to 12.
Every QC file can save results of up to 3 lot numbers, for high, normal and low controls
respectively. Enter the lot number of the control to be used into the “Lot No.” box, or SELECT
the desired number from the “Lot No.” pull-down list (if there are previously saved lot No. in
the list).
NOTE
Up to 16 digits can be entered into the “Lot No.” box of controls.
8-3
Using the QC Programs
NOTE
If a built-in barcode scanner is equipped and the “AL-WB” mode is selected,
check boxes of “Automatically scan sample ID” and “Automatically Scan
Rack No.” will appear available on the screen. CLICK the check box(s) to
select if necessary.
CLICK the “Exp. date” box and select the desired date from the calendar.
Set QC ID
If you like to run controls together with blood samples at the "Count" screen, you can set a
specific ID for the controls. If the sample ID is recognized as a QC ID when the analyzer is
running blood samples, the sample will be identified as a control sample automatically. When
the run ends, the result will be stored in the corresponding QC file of this ID.
Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.
NOTE
Refer to the instructions for use of the control for information on the lot
number, expiration date, open vial stability days, expected results and limits.
The entered expiration date should be either the expiration date printed on
the labeling or the open vial expiration date, whichever is earlier. The open
vial expiration date is calculated as follows: the date that vial is opened +
the open vial stability days.
The expected results entered should be within the display range; the limits
should be less than the expected results and neither of them should be “0”.
Otherwise, the entry is invalid.
8-4
Using the QC Programs
In case that the expected result and limit for a certain parameter are not
predefined, you can enter them after you get the analysis result
(administrator level).
After one or more groups of L-J analysis results are obtained, the
administrator can modify or delete the expected results and limits of
parameters, or get preset values (see 8.2.1 Editing L-J settings for details). If
the expected result and limit of a certain parameter are changed, they will be
highlighted in yellow.
To clear the expected results (mean) and limits (range) in the current QC file, do the following
steps.
1. CLICK the “Del. Ref. Value” button and a dialog box shown in Figure 8-3 will pop up.
2. CLICK the “Ok” button to clear all the expected results and limits in the current QC file.
Choose preset-value
If the analyzer has preset expected results and limits (see Heading 8.2.3 Reviewing L-J
analysis results for how to set the preset-value), you can set them to be preset-values for the
current QC file as instructed below.
1. CLICK the “Have preset” button and a dialog box shown in Figure 8-4 will pop up.
8-5
Using the QC Programs
If you CLICK the “Calculate by %”, the limit will be displayed in the table by percentage (%).
CLICK the “2 CV” or “3 CV” to select either double or triple coefficient of variation to be the
limit.
3. CLICK the “Ok” button to save the changes and return to the “QC setup” screen.
Print settings
CLICK the “Print” button to print out the settings of the current screen.
Import file
While editing the L-J settings, you can import the control information including lot No., level,
Exp. Date, mean and range values using a USB drive as instructed below.
1. At the “Main” screen, CLICK the “QC” button to enter the screen shown in Figure 8-5.
8-6
Using the QC Programs
2. CLICK the “Setting” button in the upper left corner of the screen to enter the screen
shown in Figure 8-6.
8-7
Using the QC Programs
3. Connect the USB drive with the QC file (under the root directory of the USB drive) to the
main unit, and then CLICK the “Import File” button. A dialog box shown in Figure 8-7 will
pop up to list all the available QC files.
4. Choose the QC file you want to import. Deselect the “Import Mean/Limit” box if you don’t
want to import the mean/limit values. CLICK the “Ok” button to start importing.
NOTE
If there are analysis results corresponding to the current file No. and lot No.,
the “Import File” button will be grayed out to disable the import function.
Switch screens
CLICK the “Main”, “Count” or “X-B QC” button at the bottom of the screen to switch to the
“Main” screen, “Count” screen or “X-B QC” screen.
A dialog box shown in Figure 8-8 will pop up when you want to switch screens.
8-8
Using the QC Programs
CLICK the “Ok” button to save the changes and switch to the corresponding screen. CLICK
the “Cancel” button to abort the changes and switch to the corresponding screen.
NOTE
The settings can be saved only when both the expected result and limit are
valid.
8-9
Using the QC Programs
WARNING
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
CAUTION
Be sure to prepare at least 1mL of control when running control in the open
vial sampling mode; at least 2mL of control in the autoloading mode.
The analysis results may be unreliable if the QC program is run with error(s)
reported. Be sure to troubleshoot your analyzer before moving on.
8-10
Using the QC Programs
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
Be sure to use the Mindray-specified controls. Using controls other than the
specified will lead to misleading results.
Refer to the instructions for use of the controls for how to store and use
them.
After mixing the control with the diluent, be sure to wait 3 minutes before
running the control.
Be sure to run the prediluted control within 30 minutes after the mixing.
Be sure to mix any control that has been prepared for a while before running
it.
NOTE
Do not open the front cover after the analysis starts.
Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be imprecise.
When the aspiration is done, remove the control vial/sample tube only when
the sample probe is out of the tube.
a) Be sure the mode is “OV-WB” and the analysis status icon is green.
b) Present the prepared control to the sample probe.
c) Press the aspirate key to start the analysis.
d) The sample probe will automatically aspirate 120μL of sample. When you hear the beep,
remove the control. The analyzer will automatically run the sample.
a) Be sure the mode is “OV-PD” and the analysis status icon is green.
8-11
Using the QC Programs
b) CLICK the “Diluent” button at the lower left corner of the screen, and a dialog box will pop
up to prompt that the analyzer is preparing for adding diluent. After the preparation, the dialog
box will close automatically and the other dialog box shown in Figure 8-10 will pop up.
c) Present a clean centrifugal tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 8-11 shows, to avoid spills and bubbles.
d)Press the aspirate key to dispense 120μL of diluent (the dispensing volume is controlled by
the analyzer) into the tube. When you hear the beep, it means the dispensing is finished.
Remove the centrifugal tube.
e)Add 40μL of control to the diluent, close the tube cap and shake the tube to mix the sample.
f)After the prediluted sample is prepared, CLICK the “Ok” button to close the dialog box. The
analyzer will start to clean the sample probe.
g)After the cleaning is finished, present the prepared control to the sample probe.
h)Press the aspirate key to start the L-J analysis. When you hear the beep, remove the
centrifugal tube.
4. When the analysis is finished, the result will be displayed on the screen. The analyzer will
be ready for the next analysis.
8-12
Using the QC Programs
NOTE
You can also aspirate 120μL of diluent by pipette into the tube.
Autoloading mode
NOTE
Do not open the front cover after the analysis starts.
If abnormal power failure occurs after the analysis starts, remove the rack(s)
manually, open the front cover to check for fallen test tube and take it out, if
any.
a) Be sure the mode is “AL-WB” and the analysis status icon is green.
b) Place the prepared control into the first tube position of the sample carrier.
c) Load sample carrier on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the carrier facing the analyzer.
d) CLICK the “Count” button at the “QC count” screen. The analyzer will start the analysis
automatically.
NOTE
When the built-in barcode scanner is not used, you can run only one control
each time.
a) Be sure the mode is “AL-WB” and the analysis status icon is green.
b) Place the prepared controls into the tube position.
c) Load racks sequentially on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the carrier facing the analyzer.
d) CLICK the “Count” button at the “QC count” screen. The analyzer will start the analysis
8-13
Using the QC Programs
automatically. The analyzer will switch the current screen to the corresponding QC file
according to the lot number scanned.
NOTE
The QC file No. of the same batch of controls must be the same.
4. After the analysis, racks come to the left tray of the autoloader. Remove them safely. The
analyzer will display the results on the current QC file and be ready for the next analysis.
NOTE
If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.
If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.
CLICK the “↑” or “↓” button below the “Pos./Total” to browse sample results saved in the
current QC file.
If a parameter is followed by an “H” or “L”, it means the analysis result has exceeded the upper
or lower limit of the reference range previously set at the “QC setup” screen.
If you see “***” as opposed to the result, it means the result is either invalid or out of the display
range. If the WBC result of the whole blood control is less than 0.5 109/L or the WBC result of
the prediluted control is less than 5 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).
CLICK the “Print” button to print the analysis results for the current control.
Switch screens
CLICK the “Main”, “Count” or “X-B QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “X-B QC” screen.
8-14
Using the QC Programs
Before running controls at the "Count" screen, when you are editing worklist or entering
information for the next sample, be sure to enter the special “QC ID” as “sample ID”. (Refer to
6.7.2 Entering work list information and 6.8.2 Entering work list information for how to enter
sample IDs)
WARNING
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
CAUTION
Be sure to prepare at least 1mL of control when running control in the open
vial sampling mode; at least 2mL of control in the autoloading mode.
The analysis results may be unreliable if the QC program is run with error(s)
reported. Be sure to troubleshoot your analyzer before moving on.
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
Be sure to use the Mindray-specified controls. Using controls other than the
specified will lead to misleading results.
Refer to the instructions for use of the controls for how to store and use
them.
8-15
Using the QC Programs
After mixing the control with the diluent, be sure to wait 3 minutes before
running the control.
Be sure to run the prediluted control within 30 minutes after the mixing.
Be sure to mix any control that has been prepared for a while before running
it.
NOTE
Do not open the front cover after the analysis starts.
Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be imprecise.
When the aspiration is done, remove the control vial/sample tube only when
the sample probe is out of the tube.
a) Be sure the “Mode” of the “Next sample” is “OV-WB” and the analysis status icon is green.
b) Present the prepared control to the sample probe.
c) Press the aspirate key to start the analysis.
d) The sample probe will automatically aspirate 120μL of sample. When you hear the beep,
remove the control. The analyzer will automatically run the sample.
a) Be sure the “Mode” of the “Next sample” is “OV-PD” and the analysis status icon is green.
b) CLICK the “Diluent” button, and a dialog box will pop up to prompt that the analyzer is
preparing for adding diluent. After the preparation, the dialog box will close automatically and
the other dialog box shown in Figure 8-10 will pop up.
8-16
Using the QC Programs
c) Present a clean centrifugal tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 8-11 shows, to avoid spills and bubbles.
d)Press the aspirate key to dispense 120μL of diluent (the dispensing volume is controlled by
the analyzer) into the tube. When you hear the beep, it means the dispensing is finished.
Remove the centrifugal tube.
e)Add 40μL of control to the diluent, close the tube cap and shake the tube to mix the sample.
f)After the prediluted sample is prepared, CLICK the “Ok” button to close the dialog box. The
analyzer will start to clean the sample probe.
g)After the cleaning is finished, present the prepared control to the sample probe.
h)Press the aspirate key to start the control analysis. When you hear the beep, remove the
centrifugal tube.
3. When the analysis is finished, the analyzer will store the results in the corresponding QC
file and get ready for the next analysis.
NOTE
You can also aspirate 120μL of diluent by pipette into the tube.
Autoloading mode
NOTE
Do not open the front cover after the analysis starts.
If abnormal power failure occurs after the analysis starts, remove the rack(s)
manually, open the front cover to check for fallen test tube and take it out, if
any.
8-17
Using the QC Programs
a) Be sure the “Mode” of the “Next sample” is “AL-WB” and the analysis status icon is green.
b) Place the prepared control into the first tube position of the sample carrier.
c) Load the tube rack on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the rack facing the analyzer.
d) CLICK the “Start” button. The analyzer will start the analysis automatically.
NOTE
When the built-in barcode scanner is not used, you can run only one control
each time.
a) Be sure the “Mode” of the “Next sample” is “AL-WB” and the analysis status icon is green.
b) Place the prepared controls into the tube positions.
c) Load racks sequentially on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the carrier facing the analyzer.
d) CLICK the "Start” button. The analyzer will start the analysis automatically.
NOTE
The QC file No. of the same batch of controls must be the same.
3. After the analysis, racks come to the left tray of the autoloader. Remove them safely. The
analyzer will store the results in the corresponding QC file and get ready for the next
analysis.
8-18
Using the QC Programs
NOTE
If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.
If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.
8-19
Using the QC Programs
SELECT desired numbers from the “File No.” and “Lot No.” pull-down lists to switch to the
corresponding “L-J QC Graph” screen.
NOTE
If less than 3 within-control results of L-J QC graph are saved, the “Mean”,
“SD” and “CV%” of every parameter are all empty.
The x-axis represents the number of the L-J analyses performed; the y-axis represents
the results of the L-J analysis.
Points linked by a green line represent results from a same L-J analysis.
8-20
Using the QC Programs
For every parameter, the upper dash line represents the expected result + limit.
For every parameter, the lower dash line represents the expected result – limit.
For every parameter (e.g. WBC), the three numbers to the left of the graph are:
For every parameter,the three numbers to the right of the L-J graph are defined and
calculated as follows:
x i
Mean= i1
n
X Mean
2
SD
i
n 1
SD
CV% 100
Mean
where, n represents how many L-J analyses are run and Xi is the result of the ith L-J analysis.
Every “■” in the graph represents a control result. They are connected by dark lines.
Black “■”: the point falls within the upper and lower limits.
Red “■”: The point falls outside the upper and lower limits, meaning either errors occurred
during the running or the value is outside the display range.
If you see any points fallen outside the control range, do the following steps until the problem is
solved. If all the steps have failed, contact Mindray customer service department or your local
distributor for assistance.
1. Check the screen for error messages and refer to Chapter 11 Troubleshooting Your
Analyzer for solutions.
8-21
Using the QC Programs
The L-J analysis results are sequentially displayed on the graph, the latest on the utmost right
of the graph. Use the arrow buttons to review the preceding or following screen.
CLICK the “←” or “→” button at the left side of the screen to review the preceding or following
result. The parameter value of each point is displayed below the parameter. The location of the
current point and the total number of the saved sample results are displayed below the
“Pos./Total”. The time when the result was obtained is displayed above the L-J graphs.
You can select results from the L-J graph to calculate the Mean, SD and CV%, and set the
calculated results to be preset-value when editing the settings. In QC files, you can set a set of
preset-values calculated for 3 lots of controls respectively. Do as instructed below.
NOTE
The preset-value can only be calculated by selecting within-control results
of at least 3 QC runs.
1. CLICK the “Calculate” button and a dialog box shown in Figure 8-15 will pop up.
2. Enter the desired data range into the “From” and “To” boxes.
3. CLICK the “Ok” button to close the dialog box, return to the “L-J QC Graph” screen and
display on the right of the screen the Mean, SD and CV% calculated from the selected
data (if you return to the “L-J QC Graph” screen after screen switching, the Mean, SD and
8-22
Using the QC Programs
CV% calculated from all within-control data will be redisplayed on the right of the QC
graph).
NOTE
If you want to recalculate the preset-value, repeat step 1 to 3 of setting the
preset-value.
4. CLICK the “Save” button and a dialog box shown in Figure 8-16 will pop up.
5. CLICK “Yes” to save the preset-value and return to the “L-J QC Graph” screen.
If out of control data appears, you can give the reasons as per the following instructions.
Move the green vertical line in the graph to the out of control point, click the “OOC” (out of
control) button, and a dialog box will pop up as follows.
8-23
Using the QC Programs
The dialog box will list all out of control data of the out of control point on the green line, all L-J
QC parameters, their expected results and limits.
Reasons of out of control points on the green line are provided in the dialog box, you can click
to select the desired ones. You can also enter reasons in the “Others” box manually, up to 100
characters.
After the edit, click the “Ok” button to save the out of control reason, close the dialog box and
return to the “L-J QC Graph” screen. Click the “Cancel” button to abort the changes, close the
dialog box and return to the “L-J QC Graph” screen.
CLICK the “Print” button to print out the current L-J graph.
Switch screens
CLICK the “Main”, “Count” or “X-B QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “X-B QC” screen.
8-24
Using the QC Programs
SELECT desired numbers from the “File No.” and “Lot No.” pull-down lists to switch to the
corresponding “L-J QC table” screen.
The L-J analysis results are sequentially displayed on the table, the latest on the utmost
bottom of the table. Use the arrow buttons to review the preceding or following screen.
If an “H” or “L” appears to the left of the result, it means the analysis result has exceeded the
upper or lower limit of the reference range previously set at the “Setting” screen.
If you see “***” as opposed to the result, it means the result is either invalid or out of the display
range. If the result of WBC whole blood control is less than 0.5 109/L or the result of WBC
prediluted control is less than 5 109/L, this analyzer will not perform the differential analysis
and all the related parameter values will be non-numeric (***).
You can delete any one or all of the L-J analysis results saved in the current QC file.
8-25
Using the QC Programs
NOTE
After every deletion, the following results will sequentially move forward
and their No. will be refreshed.
You can transmit all the L-J analysis results to an external computer (a host).
CLICK the “Com.” button and a dialog box shown in Figure 8-21 will pop up.
8-26
Using the QC Programs
To transmit all the L-J analysis results, CLICK “Yes”. Otherwise, CLICK “No”.
Data export
CLICK the “Export” Button at the L-J table screen to export the data in the current QC table to
the USB drive.
CLICK the “Print” button to printout the L-J table of the current screen.
Switch screens
CLICK the “Main”, “Count” or “X-B QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “X-B QC” screen.
NOTE
You can only export data at the L-J table screen when you log in as an
administrator.
8-27
Using the QC Programs
The X-B analysis is a weighted moving average analysis that uses values obtained from
patient samples. It uses the 3 red cell indices, MCV, MCH and MCHC to indicate the
hematology instrument performance. Effective use of X-B requires randomization of samples
and a normal cross section of patients to prevent skewing of indices.
It is recommended the X-B analysis be activated when the sample volume of your laboratory is
greater then 100 samples per day. The analyzer can save up to 500 X-B QC results. When the
saved QC results have reached the maximum number, the newest result will overwrite the
oldest.
8-28
Using the QC Programs
2. ENTER means and ranges for the parameters to be included in the X-B analysis into their
respective boxes.
NOTE
Be sure to calibrate your analyzer before trying to establish the expected
results by calculating the averages of random patient samples.
The expected results vary with areas. It is recommended they are obtained
by calculating the averages of at least 500 random patient samples.
The “Del. Ref. Value” button appears gray when there are saved expected
results and limits at the “Setting” screen. You need to delete all the X-B
analysis results before editing. See Heading 8.3.3 Reviewing X-B analysis
results for how to delete the results.
The expected results entered should be within the display range; the limits
should be less than the expected results and neither of them should be “0”.
Otherwise, the entry is invalid.
3. ENTER the desired number, 20 to 200 (20 is recommended), in the “N of S /group” box.
4. CLICK the “Open” radio button of “X-B QC” to activate the X-B analysis.
NOTE
Random samples are required for the X-B analysis. In case of known
samples of a particular type (oncology, neonatal and so forth) that will
seriously interfere with the X-B results, deactivate the X-B analysis.
CLICK the “Close” radio button of “X-B QC” to deactivate the X-B analysis.
The default setting is “Close”.
8-29
Using the QC Programs
5. Calibration data;
6. Results generated while there are errors which could affect the accuracy of the results
(insufficient aspiration volume or clogging for example).
"Sample Validity Setup" is to set up the ranges of valid RBC, MCV, MCH and MCHC results.
Only when the results of all these four parameters are within the specified ranges, the sample
results can be used for X-B QC calculation. Do as follows to set the sample validity:
CLICK the “H limit” or “L limit” of the parameter you want to customize, and then Enter the
desired numbers within the ranges shown in the table below for the four parameters.
8-30
Using the QC Programs
1.0×1012/L≤RBC≤8.0×1012/L 50fL≤MCV≤150fL
20pg≤MCH≤40pg 240g/L≤MCHC≤440g/L
All the entries should be numbers with only one decimal point.
Once the validity range is changed, the previous results will not be used in
the QC calculation as valid results, for example, if 20 valid samples are
needed for the X-B QC calculation, when you change the validity range after
10 groups of valid sample results have been acquired, these 10 groups of
results will be discarded, and only valid sample results generated
afterwards will be used in the QC calculation.
Other Functions
At the “X-B QC setting” screen, you can:
To clear the expected results (mean) and limits (range) at the current screen, do the following
steps.
1. CLICK the “Del. Ref. Value” button and a dialog box shown in Figure 8-24 will pop up.
2. CLICK “Yes” to clear all the expected results (mean) and limits (range) at the current
screen.
Switch screens
CLICK the “Main”, “Count” or “L-J QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “L-J QC” screen.
A dialog box shown in Figure 8-25 will pop up when you want to switch screens.
8-31
Using the QC Programs
CLICK the “Ok” button to save the changes and switch to the corresponding screen. CLICK
the “Cancel” button to abort the changes and switch to the corresponding screen.
NOTE
The settings can be saved only when both the expected result/limit and L/H
limits of sample validity setup are valid.
WARNING
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
CAUTION
Be sure to prepare at least 1mL of control when running control in the open
vial sampling mode; at least 2mL of control in the autoloading mode.
The analysis results may be unreliable if the QC program is run with error(s)
reported. Be sure to troubleshoot your analyzer before moving on.
8-32
Using the QC Programs
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
Be sure to use the Mindray-specified controls. Using controls other than the
specified will lead to misleading results.
Refer to the instructions for use of the controls for how to store and use
them.
After mixing the control with the diluent, be sure to wait 3 minutes before
running the control.
Be sure to run the prediluted control within 30 minutes after the mixing.
Be sure to mix any control that has been prepared for a while before running
it.
After the editing, CLICK the “Count” button to enter the screen shown in Figure 8-26.
The X-B analysis will be performed on batches of patient samples of the defined number (20 -
200). The analysis results will be displayed on the X-B graph as well as the X-B table.
8-33
Using the QC Programs
The x-axis represents the number of the X-B analyses performed; the y-axis represents
the results of the X-B analyses.
Points linked by a green line represent results from a same L-J analysis.
For every parameter, its X-B graph can display up to 500 points, 31 points per screen.
For every parameter, the upper dash line represents the expected result + limit.
For every parameter, the lower dash line represents the expected result – limit.
For every parameter (e.g. MCV), the three numbers to the left of the X-B Figure are
defined as follows:
8-34
Using the QC Programs
For every parameter,the three numbers to the right of the X-B graph are defined and
calculated as follows:
x i
Mean= i1
n
X Mean
2
SD
i
n 1
SD
CV% 100
Mean
where, n represents how many sample results are included in an X-B analysis and Xi is the ith
sample result in any X-B analysis.
Every “■” in the graph represents a control result. They are linked by dark lines.
Black “■”: the point falls within the upper and lower limits.
Red “■”: The point falls outside the upper and lower limits.
If you see any points fallen outside the control range, do the following steps until the problem is
solved. If all the steps have failed, contact Mindray customer service department or your local
distributor for assistance.
1. Check the screen for error messages. Refer to Chapter 11 Troubleshooting Your
Analyzer for solutions to any displayed error messages.
4. Run a control.
The X-B analysis results are sequentially displayed on the graph, the latest on the utmost right
8-35
Using the QC Programs
of the graph. If the results cannot be view all at once, use the arrow buttons to review the
preceding or following screen.
CLICK the “←”or “→” button at the left side of the screen to review the preceding or following
result. The parameter value of each point is displayed below the parameter. The location of the
current point and the total number of the saved sample results are displayed below the
“Pos./Total”. The saving time of result is displayed above the X-B graphs.
Switch screens
CLICK the “Main”, “Count” or “L-J QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “L-J QC” screen.
Use the arrow buttons to review the X-B analysis results of the three parameters. The X-B
analysis results are sequentially displayed on the table, the latest on the utmost bottom of the
table.
8-36
Using the QC Programs
If an “H” or “L” appears to the left of the result, it means the analysis result has exceeded the
upper or lower limit of the reference range previously set at the “X-B QC setup” screen.
CLICK the “Delete” button and a dialog box shown in Figure 8-29 will pop up.
Data export
CLICK the “Export” Button at the L-J table screen to export the data in the current QC table to
the USB drive.
Switch screens
CLICK the “Main”, “Count” or “L-J QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “L-J QC” screen.
NOTE
You can only export data at the L-J table screen when you log in as an
administrator.
8-37
9 Using the Calibration Programs
9.1 Introduction
Calibration is a procedure to standardize the analyzer by determining its deviation, if any, from
calibration references and to apply any necessary correction factors.
manual calibration.
NOTE
Calibration procedures can only be performed by users of the
administrator-level.
9-1
Using the Calibration Programs
you are going to use this analyzer for the first time (usually done by a Mindray-authorized
representative when installing the analyzer).
NOTE
All of the measured parameters must be calibrated before readings of this
analyzer can be used as valid analysis results.
9-2
Using the Calibration Programs
1. Check and make sure enough reagents have been prepared for the calibration. You need
to start over the calibration if the reagents run out during the process.
2. Do the background check. If the analyzer alarms for abnormal background results, see
Chapter 11 Troubleshooting Your Analyzer for solutions.
Enter the “Count” screen and run a vial of normal control in the OV-WB mode for 11
consecutive times. Enter the “Review” screen to check the reproducibility of the second to
eleventh runs and make sure they meet the following requirements.
3. At the “Count” screen, run a vial of high control three consecutive times and then
immediately run the diluent three consecutive times, calculate the carryover per the
following equation. The calculated carryovers shall meet the requirements in Table 9-2.
9-3
Using the Calibration Programs
Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 1.0 %
HCT ≤ 0.5 %
PLT ≤ 1.0 %
4. It is recommended that you create a log table for your analyzer. This log table should
contain all necessary information that is pertinent to your analyzer. Suggested items that
you may want to include in the log table are: calibration date, supplier of calibrator, lot
number, expected results and limits, and result of background check.
You can calibrate one of or more parameters by entering the expected results and limits of
WBC, RBC, HGB, MCV and PLT.
9-4
Using the Calibration Programs
WARNING
The probe is sharp and may contain biohazardous material. Exercise
caution when working around the probe!
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.
NOTE
Be sure to use the Mindray-specified controls. Using controls other than the
specified will lead to misleading results. Refer to the instructions for use of
the controls for how to store and use them.
9-5
Using the Calibration Programs
At the “Calibration” screen, CLICK the “Main” button to return to the “Main”, or CLICK the
“Count” button to enter the “Count” screen.
NOTE
If you have logged in as a common user, you can only view the current
calibration factors without changing them. To calibrate the analyzer, first log
out and then re-log in as the administrator.
9-6
Using the Calibration Programs
1. ENTER the password of administrator-level at the login screen to enter the “Main” screen.
3. CLICK the “Calibrator” button to enter the “Calibrator” screen shown in Figure 9-2.
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
5. ENTER the lot number of the calibrator into the “Lot No.” box.
6. CLICK the “Exp. date” box and ENTER the proper expiration date. The default setting is
the current system time.
7. ENTER the reference values into the “Mean” line for the parameters to be calibrated.
9-7
Using the Calibration Programs
CAUTION
Be sure to prepare at least 1mL of calibrator.
NOTE
Do not open the front cover after the analysis starts.
Refer to the instructions for use of the calibrator for information of the lot
number, expiration date and reference values.
The entered expiration date should be either the expiration date printed on
the labeling or the open-vial expiration date, whichever is earlier. The
open-vial expiration date is calculated as follows: the date that vial is
opened + the open-vial stability days.
b) Present the mixed calibrator to the sample probe so that the probe is well into the vial.
c) Press the aspirate key and the analyzer will aspirate 120 μL of calibrator.
a) Make sure the selected analysis mode is “OV-PD” and the “Calibration” screen is shown as
Figure 9-3.
9-8
Using the Calibration Programs
b) CLICK the “Diluent” button at the lower right of the screen, and a dialog box will pop up to
prompt that the analyzer is preparing for adding diluent. After the preparation, the dialog box
will close automatically and the other dialog box shown in Figure 9-4 will pop up.
c) Present a clean centrifugal tube to the sample probe and make sure the tube is tilted
towards the probe, as the figure below shows, to avoid spills and bubbles.
9-9
Using the Calibration Programs
d)Press the aspirate key to dispense 120μL of diluent (the dispensing volume is controlled by
the analyzer) into the tube. When you hear the beep, it means the dispensing is finished.
Remove the centrifugal tube.
e)Add 40μL of calibrator to the diluent, close the tube cap and shake the tube to mix the
sample.
f)After the prediluted sample is prepared, CLICK the “Ok” button to close the dialog box. The
analyzer will start to clean the sample probe.
g)After the cleaning is finished, present the prepared calibrator to the sample probe.
h)Press the aspirate key to start the analysis. When you hear the beep, remove the centrifugal
tube.
CAUTION
Do not re-use disposable products.
NOTE
Be sure to keep dust from the prepared diluent.
You can also aspirate 120μL of diluent by pipette into the tube.
If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.
9-10
Using the Calibration Programs
10. After the analysis, the analyzer will have different responses to different analysis results.
If non-numeric parameter values (“***”) are obtained, a dialog box of “This calibration
data is invalid!” shown in Figure 9-6 will pop up.
CLICK the “Ok” button to close the dialog box and clear the analysis results.
If the results obtained are valid, they will be shown on the screen.
Once you have done 3 valid calibration runs, the analyzer will automatically calculate the CVs
and calibration factors, both of which will be refreshed at every additional calibration run. The
calculated CVs shall be within the ranges specified in Table 9-1. The calculated calibration
factors shall be between 75% - 125%. Any calculated calibration factor that falls outside this
range will be flagged by "R". In case of this, CLICK the “Delete” button to delete the results
and rerun the calibrator. If these cases repeatedly happen, call Mindray customer service
department or your local distributor for assistance.
12. After new valid calibration factors are obtained, exit the calibration screen and verify the
new factors at the count screen.
CLICK the “Main” or “Count” button at the bottom of the screen and a dialog box shown in
Figure 9-7 will pop up.
CLICK “Yes” to save the new calibration factors (factors out of calibration range will not be
saved). CLICK “No” to switch to the corresponding screen without saving new calibration
factors.
9-11
Using the Calibration Programs
Other operations
Import file
You can use the "Import File" function to import the calibrator information (including lot No.,
mean values, etc.) stored in a USB drive.
CLICK the “Import File” button, and the dialog box shown in Figure 9-8 will pop up.
CLICK the file you want to import, and the selected file will be highlighted. CLICK “Ok” to
import the information in this file; or CLICK ”Cancel” to abort and close the dialog box.
If the import fails, a dialog box will pop up, prompting "Importing file error!". CLICK "Ok" to
close the two dialog boxes without importing, and the information at the "Calibrator" screen
will not be changed.
CLICK the “Print” button at the bottom of the screen to printout the calibration analysis results.
1. ENTER the password of administrator-level at the login screen to enter the “Main” screen.
2. CLICK the “Calibration” icon to enter the “Calibration” screen.
3. CLICK the “Blood” button to enter the “Blood” screen shown in Figure 9-9.
9-12
Using the Calibration Programs
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
If non-numeric parameter values (“***”) are obtained, a dialog box of “This calibration
data is invalid!” shown in Figure 9-10 will pop up.
9-13
Using the Calibration Programs
CLICK the “Ok” button to close the dialog box and clear the analysis results.
If the results obtained are valid, they will be shown on the screen.
The calculated CVs shall be within the ranges specified in Table 9-1 The calculated calibration
factors shall be between 75% - 125%. Any calculated calibration factor that falls outside this
range will be flagged by "R". In case of this, CLICK the “Delete” button to delete the results
and rerun the calibrator. If these cases repeatedly happen, call Mindray customer service
department or your local distributor for assistance.
10. SELECT other calibration samples from the “Sample ID” pull-down list, run the samples
as instructed in steps 7 to 9 to obtain the calibration factors of each sample.
11. After calibration factors of at least 3 fresh blood samples are obtained, CLICK the
“Calculate” button to enter the screen shown in Figure 9-11. Average the calibration
factors.
12. There may be several cases when saving the new calibration factors (Mean).
9-14
Using the Calibration Programs
If the new calibration factors (Mean) are within the valid range, a dialog box of “Save
average calibration factor?” shown in Figure 9-12 will pop up when you CLICK the
“Main” or “Count” button to exit.
CLICK “Yes” to save the new factors, close the dialog box and switch to the corresponding
screen. CLICK “No” to abort the new factors.
If the new calibration factors (Mean) are out of the valid range, a dialog box of invalid
calibration factors will pop up when you CLICK the “Main” or “Count” button to exit.
CLICK “Yes” and the analyzer will automatically clear all the data from the fresh blood
calibration.
If the new calibration factors (Mean) has not been obtained yet, a dialog box of “Discard
meta-data” shown in Figure 9-13 will pop up when you CLICK the “Main” or “Count”
button to exit.
CLICK “Yes” to abort the calibration data and switch to the corresponding screen. CLICK “No”
to stay at the fresh blood calibration screen.
Other operations
Cleaning
CLICK the “Clean” button and the analyzer will automatically perform the cleaning procedure.
Unclogging
CLICK the “Unclog” button and the analyzer will automatically perform the unclogging
procedure.
Printing
CLICK the “Print” button and the analyzer will automatically perform the printing procedure.
9-15
Using the Calibration Programs
Deleting
If you are not satisfy with calibration results of a certain run, CLICK any cell from the line at the
“Blood” calibration screen, and the selected line will be highlighted. CLICK the “Delete” button
and a dialog box shown in Figure 9-14 will pop up.
CLICK “Yes” to clear the selected data and the analyzer will recalculate the calibration factors
and the CVs of the current screen. CLICK “No” to abort the deletion. If calibration factors of a
certain sample are deleted at the calculation screen, the analyzer will refresh the average
factors of the current screen and the original calibration data of this sample will be deleted too.
NOTE
Only one group of data can be deleted each time by clicking the “Delete”
button.
You can not delete the obtained CVs and calibration factors at the “Blood”
screen.
1. Enter the “Main” as an administrator. CLICK the “Count” button to the screen shown in
Figure 9-15.
9-16
Using the Calibration Programs
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
2. Refer to relevant instructions in the Chapter 6 Operating Your Analyzer to select the
desired analysis mode at the “Count” screen.
3. Refer to the Heading 6.6 Sample Collection and Handling to run a calibration material with
known reference values 11 consecutive times.
4. Refer to the Chapter 7 Reviewing Sample Results for the CVs of the 2nd to 11th runs.
If any CV does not meet the requirements listed in Table 9-1, try to find out the reason and if
necessary, contact Mindray customer service department for assistance. If the CVs meet the
requirements, record the mean of the last 10 runs and calculate the new calibration factors as
follows:
5. Enter the “Manual” screen to check the calibration factors and calculate the new factors
per the following equation.
9-17
Using the Calibration Programs
Run the calibrator in the whole blood mode for 11 consecutive times and take the WBC results
of the 2nd to 11th runs (n=10) to calculate: 8.1, 8.0, 8.1, 8.1, 8.3, 8.3, 8.2, 8.0, 8.1, 8.3. The
obtained CV is 1.5% and Mean is 8.16, which meet the requirements in Table 9-1.
The calculated calibration factors shall be between 75% - 125%. In case of an invalid
calibration factor, try to find out the reason (e.g. calibration material not thoroughly mixed,
misoperation, etc.). Then recalibrate the analyzer and recalculate the calibration factors.
NOTE
The entered calibration factors shall be between 75.0% - 125.0% (calculate
to one decimal place).
6. ENTER the new calibration factors into the factor cell of the parameter that requires
calibration.
7. After the entry, CLICK any button at the bottom of the screen to exit the “Manual” screen. If
the new calibration factors are all between 75.0% - 125.0%, a dialog box shown in Figure
9-16 will pop up.
CLICK “Yes” to save the new calibration factors and close the dialog box. CLICK “No” to close
the dialog box without saving.
9-18
Using the Calibration Programs
If not all the new calibration factors are within the valid range, a dialog box of “Invalid
calibration factor input,quit?” will pop up.
CLICK “Yes” to switch to the corresponding screen without saving the new factors. CLICK
“No” to stay at the current screen and reenter the valid data into the box where the I-beam
stays.
Other operations
Data export
CLICK the “Export” button to export the calibration factors to a USB drive.
Printing
If the calibration factors are not modified, CLICK the “Print” button to printout the current
calibration factors directly.
If the calibration factors are modified but the new factors have not been saved yet, a dialog box
shown in Figure 9-18 will pop up when you CLICK the “Print” button.
CLICK “Yes” to printout the new calibration factors. CLICK “No” to printout the original
calibration factors.
1. Run the calibrator at least three times and check whether the means of the obtained
results are within the expected ranges.
2. Run the low, normal and high level controls, each for three times at least, and check
whether the means of the obtained results are within the expected ranges.
9-19
Using the Calibration Programs
3. Run at least three fresh blood samples with known reference values, each for three times
at least, and check whether the means of the obtained results are within the expected
ranges.
The “History” screen sequences the time, mode, calibration parameters and calibration mode
of the latest 30 calibrations. The latest calibration record is on the top of the list (No.1). The
latest record will overwrite the oldest if the calibration records are out of 30. You can use the
arrow buttons to view all records in the list but not modify or DELETE the records.
Printing
CLICK the “Print” button at the bottom of the screen to print the list information.
9-20
10 Maintaining Your Analyzer
10.1 Introduction
Preventive and corrective maintenance procedures are required to keep the BC-5800 in a
good operating condition. This analyzer provides multiple maintenance functions for this
purpose. This chapter introduces how to use the provided functions to maintain and
troubleshoot your analyzer.
All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
CAUTION
Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
10-1
Maintaining Your Analyzer
CLICK the “Service” icon at the “Main” screen to enter the “Service” screen shown in Figure
10-1, which is the default “Maintain” screen.
WARNING
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.
NOTE
Be sure to keep the reagents still for a while before using them.
10-2
Maintaining Your Analyzer
WARNING
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.
CLICK the “Replace Reagent” button at the “Maintain” screen to enter the “Replace
Reagent” screen shown in Figure 10-2.
LBA lyse
LH lyse
10-3
Maintaining Your Analyzer
Diluent
NOTE
Keep the reagent containers from any strong vibration or collision with
other objects. Otherwise unreliable error messages may be reported.
While replacing the diluent container, be sure to follow the following steps:
1) install the supporting board as shown in Figure 10-3; 2) insert the cap
assembly (shown in Figure 10-4) into the diluent container vertically, and
then secure the cap. Otherwise unreliable error messages may be reported.
10-4
Maintaining Your Analyzer
Do as follows:
1. CLICK the “LEO (I) lyse:” button at the “Replace Reagent” screen.
2. The replacement will start and the replacement progress will be displayed at the screen.
3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “Replace Reagent” screen. CLICK “Ok” to close it.
Do as follows:
1. CLICK the “LEO (II) lyse” button at the “Replace Reagent” screen.
2. The replacement will start and the replacement progress will be displayed at the screen.
3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “Replace Reagent” screen. CLICK “Ok” to close it.
Do as follows:
2. The replacement will start and the replacement progress will be displayed at the screen.
3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “Replace Reagent” screen. CLICK “Ok” to close it.
10-5
Maintaining Your Analyzer
Do as follows:
2. The replacement will start and the replacement progress will be displayed at the screen.
3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “Replace Reagent” screen. CLICK “Ok” to close it.
Do as follows:
2. The replacement will start and the replacement progress will be displayed at the screen.
3. Once the replacement is complete, a dialog box of “Reagent prime finished!” will be
displayed at the “Replace Reagent” screen. CLICK “Ok” to close it.
10.2.2 Cleaning
CLICK the “Service” icon at the “Main” screen and then CLICK the “Clean” button to enter the
“Clean” screen shown in Figure 10-5.
10-6
Maintaining Your Analyzer
Do as follows:
1. CLICK the “Remove bubbles” button at the “Clean” screen to start the process.
3. Once the removal is completed, a dialog box of “Remove bubbles finished!” will be
displayed at the “Clean” screen. CLICK “Ok” to close it.
Whole Divice
Perform this procedure when the background results of all the parameters are abnormal high.
Do as follows:
1. CLICK the “Whole Divice” button at the “Clean” screen to start the process.
2. The progress will be displayed at the screen with the message "Cleaning. Please wait...".
3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “Ok” to close it.
10-7
Maintaining Your Analyzer
10.2.3 Maintenance
CLICK the “Service” icon at the “Main” screen and then CLICK the “Maintenance” button to
enter the screen shown in Figure 10-6.
SRV
1. CLICK the "SRV" button at the “Maintenance” screen, and the dialog box shown in Figure
10-7 will pop up.
10-8
Maintaining Your Analyzer
2. CLICK "Yes" and the dialog box shown in Figure 10-8 will pop up.
3. Do as instructed by the information in the dialog box. The dialog box shown in Figure 10-9
will pop up after you press the ASPIRATE key.
4. Once the maintenance is completed, the dialog box shown in Figure 10-10 will pop up.
CLICK "Yes" to close the dialog box.
Flow Cell
1. CLICK the "Flow Cell" button at the “Maintenance” screen, and the dialog box shown in
Figure 10-11 will pop up.
10-9
Maintaining Your Analyzer
2. CLICK "Yes" and the dialog box shown in Figure 10-12 will pop up.
3. Operate as instructed by the information in the dialog box. The dialog box shown in Figure
10-13 will pop up after you press the ASPIRATE key.
4. Once the maintenance is completed, the dialog box shown in Figure 10-14 will pop up.
CLICK "Yes" to close the dialog box.
10-10
Maintaining Your Analyzer
RBC Bath
1. CLICK the "RBC Bath" button at the “Maintenance” screen, and the dialog box shown in
Figure 10-15 will pop up.
2. CLICK "Yes" and the dialog box shown in Figure 10-16 will pop up.
3. Operate as instructed by the information in the dialog box. The dialog box shown in Figure
10-17 will pop up after you press the ASPIRATE key.
4. Once the maintenance is completed, the dialog box shown in Figure 10-18 will pop up.
CLICK "Yes" to close the dialog box.
10-11
Maintaining Your Analyzer
Whole Device
1. CLICK the "Whole Device" button at the “Maintenance” screen, and the dialog box shown
in Figure 10-19 will pop up.
2. CLICK "Yes" and the dialog box shown in Figure 10-20 will pop up.
3. Operate as instructed by the information in the dialog box. The dialog box shown in Figure
10-21 will pop up after you press the ASPIRATE key.
4. Once the maintenance is completed, the dialog box shown in Figure 10-22 will pop up.
CLICK "Yes" to close the dialog box.
10-12
Maintaining Your Analyzer
WC
1. CLICK the "WC" button at the “Maintenance” screen, and the dialog box shown in Figure
10-23 will pop up.-
2. CLICK "Yes" and the dialog box shown in Figure 10-24 will pop up.
3. Operate as instructed by the information in the dialog box. The dialog box shown in Figure
10-25 will pop up after you press the ASPIRATE key.
10-13
Maintaining Your Analyzer
4. Once the maintenance is completed, the dialog box shown in Figure 10-26 will pop up.
CLICK "Yes" to close the dialog box.
Aperture
Unclog
Perform this procedure to zap and flush the aperture to unclog the RBC aperture or prevent
clogging.
Do as follows:
2. The analyzer will start unclogging and the progress will be displayed in a dialog box shown
in Figure 10-27.
3. Once the unclogging is completed, a dialog box shown in Figure 10-28 will pop up. CLICK
“Ok” to close it.
10-14
Maintaining Your Analyzer
10.2.4 Pack-up
CLICK the “Service” icon in the “Main” screen and then CLICK the “Pack-up” button to enter
the screen shown in Figure 10-29.
If the analyzer is not to be used for over 1 week, you should perform the pack-up procedure
and shutdown the analyzer.
Do as follows:
1. CLICK the “Pack-up” button at the “Pack-up” screen and a dialog box shown in Figure
10-30 will pop up.
2. CLICK “No” to close the dialog box and return to the “Maintenance” screen. CLICK “Yes”
to proceed with the pack-up and a dialog box shown in Figure 10-31 will pop up.
10-15
Maintaining Your Analyzer
3. Remove all reagent pickup tube assemblies from their containers per the prompt of the
dialog box.
4. CLICK “Ok” to start the fluidic system emptying. The progress bar will be displayed at the
screen. Once the progress bar disappears, a dialog box shown in Figure 10-32 will pop up.
5. Place all reagent pickup tube assemblies into a distilled water container per the prompt of
the dialog box. CLICK “Ok” to start to clean the analyzer with distilled water. After the
cleaning, a dialog box shown in Figure 10-33 will pop up.
6. Remove all the pickup tube assemblies from the distilled water container and place them
into the waste container. CLICK “Ok” to start to empty the fluidic system.
7. After the emptying, the analyzer starts backing up data automatically, and the dialog box
shown in Figure 10-34 will pop up.
10-16
Maintaining Your Analyzer
8. When the backup is completed, place the power switch to the OFF (O) position to turn off
your analyzer.
10.2.5 Sterilization
The user shall perform daily cleaning and sterilization to the cover of the analyzer. Use the
specified materials to sterilize the equipment only. For any damage to the instrument or other
accidents caused by using materials other than specified, Mindray will not provide any
warranty.
Mindray does not claim the validity of the listed chemicals in infection control. For effective
control of infection, please consult the Infection Prevention Department of the hospital or the
epidemic professionals.
The sterilization may damage the analyzer to some extent. It is recommended to perform
sterilization only when necessary according to your laboratory protocol. Remember to clean
the equipment before sterilizing.
Recommended disinfectant: 70% ethanol, 70% isopropyl alcohol and Cidex 2% Glutaral +
Activator.
Prohibited disinfectant: 3% hydrogen peroxide, Aerodesin 2000, Cidex OPA.
10-17
Maintaining Your Analyzer
The “Status” screen shows the current status of the analyzer. At the “Status” screen, you can
check:
the position
At the “Status” screen, you can only check the displayed status information without changing
them. The items displayed contribute significantly to troubleshooting your analyzer.
CLICK the “Status” button at the bottom of the “Service” screen and then CLICK the
“Version” button to enter the screen shown in Figure 10-35.
10-18
Maintaining Your Analyzer
To exit the “Version” screen, CLICK any other button at the left of the screen or any button at
the bottom.
CLICK the “Temp & Pres” button at the “Status” screen to enter the screen shown in Figure
10-36.
The screen also shows the normal range of each setting, which helps to troubleshoot the
analyzer.
To exit the “Temp & Pres” screen, CLICK any other button at the left of the screen or any
button at the bottom.
10-19
Maintaining Your Analyzer
CLICK the “Vol. & Cur.” button at the “Status” screen to enter the screen shown in Figure
10-37.
The “Vol. & Cur.” screen shows the voltages of the power supply +24V, +12V, +5V and AVCC
(5V) and the current of the laser diode. It also shows the normal range of each setting, which
helps to troubleshoot the analyzer.
To exit the “Vol. & Cur.” screen, CLICK any other button at the left of the screen or any button
at the bottom.
10.3.4 Position
At the “Position” screen, you can check:
10-20
Maintaining Your Analyzer
CLICK the “Position” button at the “Status” screen to enter the screen shown in Figure 10-38.
To exit the “Position” screen, CLICK any other button at the left of the screen or any button at
the bottom.
CLICK the “Func. Set” button at the “Status” screen to enter the screen shown in Figure
10-39.
10-21
Maintaining Your Analyzer
To exit the “Func. set” screen, CLICK any other button at the left of the screen or any button at
the bottom.
10-22
Maintaining Your Analyzer
The self-test program is an important method to troubleshoot the analyzer. At the “self-test”
screen, you can do:
Dobber self-test
At the “Self-test” screen, you can do only one self-test each time. Before proceeding with the
next self-test, make sure the current self-test is complete.
CLICK the “Self-test” button at the bottom of the “Service” screen to enter the “Mechanical”
screen shown in Figure 10-40.
10-23
Maintaining Your Analyzer
CLICK the corresponding button to check the desired item. A “Normal” or “Error” will appear
at the “Results” column after each self-test.
To exit the “Mechanical” screen, CLICK any other button at the left of the screen or any button
at the bottom.
10-24
Maintaining Your Analyzer
CLICK the corresponding button to check the desired item. Mostly, the “Normal” or “Error” will
appear at the “Results” column after the self-test. But for the ASPIRATE key self-test, there is
a little difference. CLICK the “ASPIRATE key” button, a dialog box shown in Figure 10-42 will
pop up and a count-down will begin.
Press the ASPIRATE key per the prompt, and a “Normal” will appear at the “Results” column
if the result is normal. An “Error” will appear at the “Results” column if the result is abnormal or
the key is not pressed within the given time.
For the “Laser box switch” self-test, an “On” or “Off” will appear at the “Results” column.
To exit the “Circuit” screen, CLICK any other button at the left of the screen or any button at
the bottom.
10-25
Maintaining Your Analyzer
At the “Valve” screen, each number circled represents a valve. To test a valve, CLICK the
corresponding number and the self-test to this valve will begin. If the corresponding number
area appears gray, the analyzer will not do the self-test to the valve.
Before the self-test begins, be sure the pneumatic unit is shut down. Otherwise, a prompt of
“Please turn off air compressor firstly.” will appears on the screen. CLICK the “Shut
compressor” button to close the pneumatic unit. The corresponding number area will appear
yellow during the test. It will turn red if the valve is abnormal. If the valve is normal, the
corresponding number area will turn green and the sounds of opening and closing the valve
are normal.
To do the self-test to all valves, CLICK the “Test all” button. During the self-test, the “Test all”
button will turn to the “Cancel” button. To stop the test, CLICK the “Cancel” button and a
dialog box of “Stop all valve self-tests?” will pop up. CLICK “Ok” to confirm the stop.
To exit the “Valve” screen, CLICK any other button at the left of the screen or any button at the
bottom. Then, the analyzer will open the pneumatic unit automatically.
10-26
Maintaining Your Analyzer
1. CLICK the “Dobber” button at the “Self-test” screen to enter the screen shown in
Figure 10-44.
2. CLICK the corresponding button to check the desired item. The “Normal” or “Error”
will appear at the “Results” column after the self-test.
To exit the “Dobber” screen, CLICK any other button at the left of the screen or any button at
the bottom.
Do as follows:
1. CLICK the “Touchscreen” button at the “Self-test” screen to enter the screen shown in
Figure 10-45.
10-27
Maintaining Your Analyzer
2. CLICK the “Calibrate” button in the middle of the screen and the screen will be shown as
Figure 10-46.
10-28
Maintaining Your Analyzer
NOTE
Do not click with the mouse to calibrate the touchscreen.
3. CLICK the red point at the upper left corner of the screen as prompted to start the
calibration.
4. Then CLICK the red point at the lower right corner of the screen and the screen will be
shown as Figure 10-47.
5. CLICK the blue rectangular area in the middle of the screen and the screen will display
“Calibration succeeded!”. The calibration screen will close automatically after several
seconds.
6. To exit the “Touchscreen” screen, CLICK any other button at the left of the screen or any
button at the bottom.
10-29
Maintaining Your Analyzer
The “Log” screen records all activities of the analyzer. It contributes significantly to searching
for operation history and troubleshooting the analyzer.
The analyzer can save up to 200,000 log records. When the maximum number has been
reached, the newest log will overwrite the oldest. You can only browse or print the logs without
changing them.
CLICK the “Log” button at the bottom of the “Service” screen to enter the screen shown in
Figure 10-48.
Browse
As a common user, you can only CLICK the “All”, “Set paras”, “Others” or “Error info.” button
to browse the corresponding information.
Detail
CLCK the “Detail…” button and a dialog box shown in Figure 10-66 will pop up.
10-30
Maintaining Your Analyzer
Exit
To exit the “Log” screen, CLICK any other button at the left of the screen or any button at the
bottom.
10-31
Maintaining Your Analyzer
You can enter the “Init” screen to resume the factory default, if you need to initialize the
touchscreen or resume the factory expected results.
CLICK the “Init” button at the “Service” screen to enter the screen shown in Figure 10-50.
1. CLICK the “Ref. ranges & units” check box to initialize the reference range and units.
2. CLICK the check box to select it. CLICK the check box again to deselect it.
3. After the selection, CLICK the “Init.” button on the screen. If the screen prompts that the
initialization succeeded, the initialization is complete. If the screen prompts that the
initialization failed, you need to contact Mindray customer service department or your local
distributor for assistance.
10-32
Maintaining Your Analyzer
To exit the “Init” screen, CLICK any other button at the bottom of the screen.
10-33
Maintaining Your Analyzer
You can perform some daily maintenance procedures using the shortcut buttons at the
"Count" screen shown in Figure 10-51.
“Background” button
CLICK the “Background” button at the bottom of the “Count” screen to do a background
count. The background count will work in the “OV-WB-CBC” mode. The results of background
count shall meet the background range in Appendix B.
“Clean” button
When the background values of each parameter are all high, CLICK the “Clean” button at the
bottom of the “Count” screen to clean the overall fluidic system. The cleaning will last about 2
minutes. Place an empty cup under the open vial sampling probe to prevent possible reagents
dripping on the countertop.
“Unclog” button
CLICK the “Unclog” button at the bottom of the “Count” screen directly to prevent or remove
the RBC clogging.
10-34
Maintaining Your Analyzer
Do as follows:
WARNING
The SRV tray may contain biohazardous materials. Exercise caution to avoid
direct contact with the tray.
2. After a few minutes, open the front cover and pull out the SRV tray shown in Figure 10-52.
CAUTION
To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
10-35
Maintaining Your Analyzer
SRV tray
CAUTION
When removing the SRV tray, do not loosen the thumbscrew fixing the
sample probe; otherwise air may enter the sample probe and unreliable
results may be obtained.
To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
NOTE
Reassemble the SRV tray by facing the side with the groove up.
10-36
Maintaining Your Analyzer
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.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.
The sample probe and the SRV may contain biohazardous materials.
Exercise caution to avoid direct contact with the probe and the SRV when
working around them.
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.
CAUTION
The SRV is so fragile that any knock or drop may damage it. Exercise
caution when disassembling/assembling or cleaning the SRV. Do not loosen
or bend the tiny steel tubes at sides of the SRV.
After the analyzer is turned off, wait at least 30 seconds to release the
pressure and vacuum accumulated in the pneumatic lines. Do not perform
any maintenance or replacing procedure immediately after you turn off the
analyzer.
Do as follows:
CAUTION
To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
10-37
Maintaining Your Analyzer
3. Remove the SRV tray and pull the probe wipe assembly down to the lowest position as
shown in Figure 10-53.
CAUTION
The sample probe should be completely separated from the probe wipe
when the SRV is disassembled. Otherwise, the probe may be deformed or
the probe wipe may be damaged.
10-38
Maintaining Your Analyzer
6. Remove the sampling valve and the rotor valve of the SRV respectively as shown in Figure
10-55.
NOTE
When the SRV is disassembled, reagent may leak from the tubes. Place a
dry cloth or tissue under the SRV to absorb any reagent.
Do not use too much force to pull tubes on sides of the SRV when
disassembling the SRV. Otherwise, the tubes may be disconnected and the
leakage may be caused.
7. Inject some probe cleanser into holes and grooves of the sampling valve, rotor valve and
rear fixed valve respectively. You can also brush holes and grooves gently with probe
cleanser, as shown in Figure 10-56.
10-39
Maintaining Your Analyzer
8. Use clean lint-free damp tissues to wipe the valve contact surfaces clean with probe
cleanser, as Figure 10-57 shows. Then wash the valves with distilled water.
NOTE
Make sure no dust should be found in the holes and grooves and on the
surfaces after the cleaning.
9. Reassemble the rotor valve and sampling valve in the reverse order.
10-40
Maintaining Your Analyzer
NOTE
The valve contact surfaces must be damp when the SRV is reassembled.
Position the metal knob between the two stoppers when reassembling the
rotor valve. Otherwise, the SRV may not function.
Be sure the sampling valve, rotor valve and rear fixed valve of the SRV
attach well after the reassembly.
10. Reassemble the constant screw by turning it clockwise and tightening it.
11. With sample probe through the center of the probe wipe, lift the probe wipe assembly back
to the original position when the analyzer is turned off.
12. Reassemble the SRV tray and close the front cover of the analyzer.
CAUTION
Be sure the sample probe is inserted through the probe wipe, and the probe
wipe is placed back to the original position when the analyzer is turned off.
Otherwise, the probe wipe will be stuck and cannot work after the analyzer is
turned on.
After the SRV tray is reassembled, check whether the thumbscrew on the top
of the sample probe is loose. If so, tighten it. Otherwise, it can cause air to
come into the probe and lead to unreliable analysis result.
To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
To avoid damage to the components of the analyzer, close the front cover
gently.
10-41
Maintaining Your Analyzer
NOTE
Once reagents spill on the surface of the analyzer, wipe them off with a damp
cloth or tissue as soon as possible.
13. Do a background check after the startup. Be sure the background values are within the
required range.
WARNING
The sample probe and the SRV may contain biohazardous materials.
Exercise caution to avoid direct contact with the probe and the SRV when
working around them.
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.
NOTE
When disassembling, cleaning and reassembling the probe wipe, do not use
too much force. Otherwise, the probe wipe of the open vial sampling unit
will be damaged.
Do as follows:
1. Turn off the power of the analyzer and open the front cover after a few minutes.
2. Pull the probe wipe assembly down to the lowest position and remove the probe wipe from
the probe.
10-42
Maintaining Your Analyzer
3. Separate the probe wipe from the probe wipe assembly as shown in Figure 10-59.
Disconnect the tubes from the probe wipe.
Figure 10-59 Separating the probe wipe of the open vial sampling unit
4. Wash the probe wipe with clean tap water, wipe it dry and reassemble it in the reverse
order. Place the probe wipe assembly to the original position when the analyzer is turned
off.
CAUTION
Be sure the sample probe is inserted through the probe wipe, and the probe
wipe is placed back to the original position when the analyzer is turned off.
Otherwise, the probe wipe will be stuck and cannot work after the analyzer is
turned on.
Disconnect the tubes by pinching the ends of connects, swaying them while
pulling them outward. Do not use too much force while disconnecting the
tubes. Otherwise, the probe wipe of the open vial sampling unit will be
damaged.
10-43
Maintaining Your Analyzer
All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
WARNING
To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
CAUTION
To avoid damage to the components of the analyzer, close the front cover
gently.
After the analyzer is turned off, wait at least 30 seconds to release the
pressure and vacuum accumulated in the pneumatic lines. Do not perform
any maintenance or replacing procedure immediately after you turn off the
analyzer.
If the tray under the piercing unit is accumulated with saline and dirt, you should clean the tray.
Do as follows:
2. Open the front cover of the analyzer after a few minutes and you will see the tray, as
shown in Figure 10-60.
10-44
Maintaining Your Analyzer
3. Remove the tray and flush it with clean tap water. Then wipe it dry.
4. Reassemble the tray after cleaning and close the front cover of the analyzer.
10-45
Maintaining Your Analyzer
10.9 Adjustment
10-46
Maintaining Your Analyzer
0.25MPa pressure
Do as follows:
1. Use a Philips screwdriver to loosen the fixing screw of 0.25MPa pressure regulator, as
shown in Figure 10-63.
fixing screw
2. Check the pressure value in the “PS1 (250)” column at the “Temp & Pres” screen, then
turn the adjustment knob clockwise to increase the pressure, counterclockwise to
decrease.
10-47
Maintaining Your Analyzer
NOTE
If the pressure is adjusted too high, you should adjust it to the lowest level
before readjusting it to the desired level.
3. Check whether the pressure value shown in the “PS1 (250)” column is within the normal
range of (250±10)Kpa. If not, repeat step 2 until it is within the normal range.
4. After the adjustment, tighten the lock screw of the 0.25MPa pressure regulator.
Do as follows:
1. Pull up the adjustment knob of the 0.16MPa pressure regulator as shown in Figure 10-65.
2. Check the pressure value in the “PS2 (160)” column at the “Temp & Pres” screen, then
turn the adjustment knob clockwise to increase the pressure, counterclockwise to
decrease.
3. Check whether the pressure value shown in the “PS2 (160)” column is within the normal
range of (160±1)Kpa. If not, repeat step 2 until it is within the normal range.
4. After the adjustment, push the knob of the 0.16MPa pressure regulator. If you are not able
to push the knob, turn the knob slightly and then try again.
10-48
Maintaining Your Analyzer
Do as follows:
1. Use a wrench to loosen the lock nut of the0.07MPa pressure regulator shown in Figure
10-66.
2. Check the pressure value in the “PS3 (70)” column at the “Temp & Pres” screen, then turn
the adjustment knob clockwise to increase the pressure, counterclockwise to decrease.
3. Check whether the pressure value shown in the “PS3 (70)” column is within the normal
range of (70±1)Kpa. If not, repeat step 2 until it is within the normal range.
4. After the adjustment, push the knob of the 0.07MPa pressure regulator. If you are not able
to push the knob, turn the knob slightly and then try again.
Do as follows:
1. Pull up the adjustment knob of the - 0.04MPa pressure regulator as shown in Figure
10-67.
10-49
Maintaining Your Analyzer
2. Check the pressure value in the “PS5 (-40)” column at the “Temp & Pres” screen, then
turn the adjustment knob clockwise to increase the pressure, counterclockwise to
decrease.
3. Check whether the pressure value shown in the “PS5 (-40)” column is within the normal
range of (- 40±1)Kpa. If not, repeat step 2 until it is within the normal range.
4. After the adjustment, push the knob of the - 0.04MPa pressure regulator.
10-50
Maintaining Your Analyzer
NOTE
To ensure the analyzer functions normally, check the piercer periodically
and replace it in time.
You should replace the piercer if it is worn out. Contact Mindray customer service department
or your local distributor for assistance, or follow steps below to replace it.
1. Turn off the power of the analyzer. Open the front cover of the analyzer after a few minutes;
loosen the fixing screws shown in Figure 10-68 to remove the piercer cover.
2. Disconnect tubes from the piercer and probe wipe. Loosen the fixing nut at the end of the
piercer, as Figure 10-69 shows.
10-51
Maintaining Your Analyzer
4. Figure 10-70 shows. Remove the block and then the piercer in the direction shown in
Figure 10-71.
10-52
Maintaining Your Analyzer
5. Take a new piercer from the accessory kit, insert it through the probe wipe, and
reassemble the fixing block to fix the new piercer.
6. Reconnect the tubes to the piercer and probe wipe, reassemble the piercer cover and
close the front cover of the analyzer.
Do as follows:
1. Turn off the power of the analyzer. Open the front cover of the analyzer after a few minutes
and you will see the pincher, as shown in Figure 10-72.
2. Unscrew the fixing screws shown in Figure 10-73 to remove the protective cover for the
pincher. Unscrew the fixing screw shown in Figure 10-74 to remove the pincher.
10-53
Maintaining Your Analyzer
4. Reassemble the protective cover and close the front cover of the analyzer.
10-54
Maintaining Your Analyzer
10-55
11 Troubleshooting Your Analyzer
11.1 Introduction
This chapter contains information that is helpful in locating and correcting problems that may
occur during operation of your analyzer.
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 analyzer. If the
recommended solution fails to solve the problem, contact Mindray customer
service department or your local distributor.
11-1
Troubleshooting Your Analyzer
During the operation, if error(s) is detected, the analyzer will beep and display the
corresponding error message. In the error message area, the severity levels are discriminated
from high to low by background colors in the order of red, carmine, yellow, green and
transparent. You can CLICK the left mouse button, the external keyboard or anywhere on the
touchscreen to stop the beep.
CLICK the error message area and the corresponding troubleshooting dialog box shown as
Figure 11-1 will pop up.
You can see the error name(s) and the corresponding troubleshooting information in the
pop-up dialog box. The error names are displayed in order. You can CLICK the error name to
select (highlight) it and check the troubleshooting information in the “Troubleshooting” box.
The troubleshooting information of the first error is displayed. Follow the instructions in the
dialog box to remove error(s). To close the dialog box, CLICK the “Close” button.
11-2
Troubleshooting Your Analyzer
department.
Cistern operation error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Rack(s) loading error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Rack(s) feeding error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Rack(s) unloading error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
AL: unloading tray is full 1. Remove the rack(s) from the unloading tray.
2. If the error still exists, contact our customer service
department.
Autoloader is working 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Tube ID read error 1. Check whether the barcode is pasted incorrectly, damaged, or
illegible.
2. If there is nothing wrong with the barcode, press the "Remove
error" button to check the built-in barcode scanner.
3. If the error still exists, contact our customer service
department.
Rack(s) moved manually 1. Reposition the rack(s).
2. If the error still exists, contact our customer service
department.
Scanner setup error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Tube barcode is too long 1. Check whether the character length of the barcode is longer
than 15.
2. If the barcode character length is not overlong, and this error
still exists, contact our customer service department.
Manipulator pinch error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator elevation error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
11-3
Troubleshooting Your Analyzer
11-4
Troubleshooting Your Analyzer
11-5
Troubleshooting Your Analyzer
DIFF stirring motor 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
BASO stirring motor 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
Laser diode temp. error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Laser diode current error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Preheat bath temp. error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Reaction bath temp. error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Temperature out of working 1. Make sure the ambient temperature is within the normal
range range [15, 30].
2. Analysis results may be incorrect if the ambient temperature
is out of the normal range.
3. If the ambient temperature is within the normal range, press
the "Remove error" button to remove the error.
Temperature out of 1. The ambient temperature is out of the analysis allowable
operating range range [4, 40].
2. Make sure the ambient temperature is within the normal
range [15, 30], and then press the "Remove error" button to
remove the error.
3. If the error still exists, contact our customer service
department.
250 KPA pressure 1. Check whether the pneumatic unit indicator is on.
abnormal 2. If the indicator is off, check the power cord connection of the
pneumatic unit, and check that the analyzer is properly
connected to the pneumatic unit.
3. If the indicator is on, see Heading 10.9 Adjustment and tune
the PS1(250) pressure until the pressure becomes normal.
4. When it is normal, press the "Remove error" button to remove
this error.
5. If the error still exists, contact our customer service
department.
160 KPA pressure 1. See Heading 10.9 Adjustment and tune the PS2(160)
abnormal pressure until the pressure becomes normal.
2. When it is normal, press the "Remove error" button to remove
11-6
Troubleshooting Your Analyzer
this error.
3. If the error still exists, contact our customer service
department.
70 KPA pressure abnormal 1. See Heading 10.9 Adjustment and tune the PS3(70) pressure
until the pressure becomes normal.
2. When it is normal, press the "Remove error" button to remove
this error.
3. If the error still exists, contact our customer service
department.
-40 KPA pressure 1. See Heading 10.9 Adjustment and tune the PS4(-40)
abnormal pressure until the pressure becomes normal.
2. When it is normal, press the "Remove error" button to remove
this error.
3. If the error still exists, contact our customer service
department.
-85 KPA pressure 1. Press the "Remove error" button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
Data collection sub-system 1. Press the “Remove error” button to remove this error.
com. error 2. If the error still exists, contact our customer service
department.
Main board chip error 1. Perform the shutdown procedure to shut down the analyzer
and then restart it.
2. If the error still exists, contact our customer service
department.
Real-time clock error 1. See Heading 5.2.1 Settings to reset the system time.
2. If the error still exists, or if it is removed yet appears again at
the next startup, contact our customer service department.
WBC background voltage 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
RBC aperture voltage 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
HGB error 1. See Heading 5.3.1 Settings to adjust the HGB background
voltage to 2.0-2.4 V. 2.28 V is recommended.
2. If the error still exists, contact our customer service
department.
HGB adjust 1. See Heading 5.3.1 Settings to adjust the HGB background
voltage to 2.0-2.4 V. 2.28 V is recommended.
2. If the error still exists, contact our customer service
department.
RBC clog 1. Press the “Remove error” button to remove this error.
2. If the error reports frequently, see Heading 10.2.3
11-7
Troubleshooting Your Analyzer
11-8
Troubleshooting Your Analyzer
11-9
12 Appendices
A Index
A C
adapter, 6-54 calibration
Adjustment, 10-46 auto calibration, 9-7
AL auto calibration, 9-6
unloading tray is full, 11-3 conditions, 9-2
analyzer manual calibration, 9-16
intended use, 2-2 calibrator, 2-23
name, 2-1 Carryover, B-8
Aspiration, 3-2 Cistern operation error, 11-3
auto calibration Cleaning, 10-6
commercial calibrators, 9-7 Cleaning Manually, 10-35
fresh blood samples, 9-12 Close Tube Sampler, 2-12
Auto communication operation error, 11-9 control, 2-23
Autoloader, 2-12 CV
Autoloader is working, 11-3 definition, 7-16
Auto-print records full. Cannot add new job formula, 7-15
now., 11-9
D
B
Data collection sub-system com. error,
Background abnormal, 11-8 11-7
barcode, B-11 DIFF stirring motor abnormal, 11-6
barcode label, 6-53 DILUENT
Bas# definition, 2-22
definition, 3-9 Diluent expired, 11-8
formula, 3-9 Dilution, 3-3
Bas%
definition, 3-9
E
formula, 3-9
BASO stirring motor abnormal, 11-6 Electrical Impedance method, 3-12
blank photocurrent, 3-11 Eos#
definition, 3-10
formula, 3-10
A-1
Appendices
F M
flag, 6-44 M-58LBA LYSE
Flow Cytometry by Laser, 3-7 definition, 2-23
Front cover open, 11-5 M-58LEO(I) LYSE
definition, 2-22
M-58LEO(II) LYSE
H
definition, 2-22
HCT M-58LH LYSE
formula, 3-14 definition, 2-22
Heater Main board chip error, 11-7
preheat bath temp. sensor error, 11-4 Maintenance, 10-8
reaction bath temp. sensor error, 11-4 maintenance program, 10-2
HGB Manipulator is working, 11-4
formula, 3-11 Manipulator elevation error, 11-3
measurement, 3-11 Manipulator mix error, 11-4
HGB adjust, 11-7 MCH
HGB error, 11-7 formula, 3-14
MCHC
formula, 3-14
I MCV
A-2
Appendices
PDW, 2-2
N PLT, 2-2
RBC, 2-2
Network communication error, 11-8
RDW-CV, 2-2
Network connection error, 11-8
RDW-SD, 2-2
Neu#
WBC, 2-2
definition, 3-9
PCT
formula, 3-9
formula, 3-15
Neu%
PDB
definition, 3-9
chip error, 11-2
formula, 3-9
PDW
No Diluent, 11-4
definition, 3-15
No LBA lyse, 11-5
PLT
No LEO(I) lyse, 11-5
definition, 3-14
No LEO(II) lyse, 11-5
Pneumatic Unit Control Interface, 2-12
No LH lyse, 11-4
Pop-up keyboard, 2-19
Power drive sub-system communication
O error, 11-2
predilute
Overall Maintenance, 10-15
samples collection and handling, 6-12
Preheat bath temp. error, 11-6
P Printer out of paper, 11-9
Printer paper jammed, 11-9
parameter PROBE CLEANSER
ALY# (RUO), 2-2 definition, 2-23
ALY% (RUO), 2-3 ps data generation error, 11-9
Bas#, 2-2 Pump syringe action error, 11-4
Bas%, 2-2
Eos#, 2-2
Eos%, 2-3 Q
HCT, 2-2
quality control
HGB, 2-2
L-J analysis, 8-2
LIC# (RUO), 2-2
X-B analysis, 8-28
LIC% (RUO), 2-3
Lym#, 2-2
Lym%, 2-3 R
MCH, 2-2
Rack(s) feeding error, 11-3
MCHC, 2-2
Rack(s) loading error, 11-3
MCV, 2-2
Rack(s) moved manually, 11-3
Mon#, 2-2
Rack(s) unloading error, 11-3
Mon%, 2-3
RBC
MPV, 2-2
definition, 3-13
Neu#, 2-2
RBC aperture voltage abnormal, 11-7
Neu%, 2-3
RBC bubbles, 11-8
PCT, 2-2
A-3
Appendices
A-4
B Specifications
B.1 Classification
According to the CE classification, the BC-5800 belongs to In vitro diagnostic medical devices
other than those covered by Annex II and devices for performance evaluation.
B.2 Calibrator
Blood samples with known values.
Specified by manufacturer.
B.3 Controls
Specified by manufacturer.
B.4 Reagents
M-58 DILUENT M-58D DILUENT
M-58LEO (I) LYSE
M-58 LYSE M-58LEO (II) LYSE
M-58LH LYSE
M-58LBA LYSE
M-58 CLEANSER PROBE CLEANSER
B-1
Appendices
B-2
Appendices
B-3
Appendices
B-4
Appendices
454235 Greiner VACUETTE Plastic K2EDTA with 13x75 Twist cap, pink
® GEL
Crossmatc
h tubes
B.6 Parameters
Parameter Abbreviation Default Unit
White Blood Cell count WBC 109/L
Neutrophils number Neu# 109/L
Lymphocytes number Lym# 109/L
Monocytes number Mon# 109/L
Eosinophils number Eos# 109/L
Basophils number Bas# 109/L
Abnormal Lymphocytes number ALY# (RUO) 109/L
Large Immature Cells number LIC# (RUO) 109/L
Neutrophils percentage Neu% %
Lymphocytes percentage Lym% %
Monocytes percentage Mon% %
Eosinophils percentage Eos% %
Basophils percentage Bas% %
Abnormal Lymphocytes percentage ALY% (RUO) %
Large Immature Cells percentage LIC% (RUO) %
Red Blood Cell count RBC 1012/L
Hemoglobin Concentration HGB g/L
Hematocrit HCT %
B-5
Appendices
B.7.2 Throughput
Autoloading 90 analyses / hour
Open vial sampling (whole blood) 80 seconds / analysis
B-6
Appendices
B.8.4 Compatibility
Deviation ranges: WBC ≤±5%, RBC ≤±2.5%, HGB ≤±2.5%, PLT ≤±8%, HCT/MCV ≤±3%.
B.8.6 Reproducibility
These reproducibility requirements apply only to the situation in which a qualified sample has
been run for 11 times and the results of the 2nd to 11th runs are used to calculate the
reproducibilities.
Parameter Condition Whole Blood Reproducibility CV /
absolute deviation d※
WBC (4.0~15.0)×109/L ≤ 2.5%
Neu% 50.0%~60.0% ±5.0%
Lym% 25.0%~35.0% ±3.0%
B-7
Appendices
B.8.7 Carryover
Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 1.0 %
HCT ≤ 0.5 %
PLT ≤ 1.0 %
NOTE
Be sure to use the specified devices only.
If you need to use a USB extension cable, be sure that the model and length
of the cable are as specified in this manual and only use it to connect the
USB drive and the analyzer.
B-8
Appendices
B.10 Interfaces
NOTE
The USB interfaces on the back of the analyzer shall only be used to
connect the peripheral devices specified in this manual. See Section B.9
Input/output device for details about supported devices and models.
4 USB interfaces
B-9
Appendices
WARNING
Be sure to use the fuse of the specified type and rating.
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.
B.13 Sound
Maximal sound: 77 dB.
Running temperature: 10 ℃ - 40 ℃.
Relative humidity: 10 % - 90 %
B-10
Appendices
Height
Depth
Width
CODE128 Self-checking(check ditgit is always included) No more than 15 characters (Sample ID)
CODE93 Self-checking(check ditgit is always included) No more than 15 characters (Sample ID)
B-11
Appendices
Notice:
For the presence of any invalid barcode shown below, replace it with a valid one.
B-12
Appendices
B-13
C Precautions, Limitations and Hazards
C.1 Introduction
You will find the following symbols in this manual.
C.1.2 Limitations
Whenever the results are outside the normal limits, it is recommended that the laboratory
following whatever written protocol is in place for validating results.
If an error occurs, the analyzer displays the corresponding error message In case of errors
related to the fluidic system (such as clogging or bubbles), it is recommended that you re-run
the sample after removing the error.
If the PLT value is less than 100 109 / L, it is recommended the result be verified by a
microscope.
C.1.3 Maintenance
The maintenance instructions in Chapter 10 describe corrective and preventive procedures
that must be followed to ensure proper operation and performance of your analyzer.
C-1
Appendices
C.2 Biohazard
All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
C-2
Appendices
C.3 Warnings
WARNING
It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or injury of human health.
Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.
Before turning on the analyzer, make sure the input voltage meets the
requirements.
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.
Keep your clothes, hair and hands away from the moving parts to avoid
injury.
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.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
The SRV tray may contain biohazardous materials. Exercise caution to avoid
C-3
Appendices
The sample probe and the SRV may contain biohazardous materials.
Exercise caution to avoid direct contact with the probe and the SRV when
working around them.
C-4
Appendices
C.4 Cautions
CAUTION
To avoid damage, do not turn on/off the power of the analyzer continually in
a short time.
Avoid the spillage of any reagent or liquid which may get into the analyzer
and cause damage.
The analysis results may be unreliable if the QC program is run with error(s)
reported. Be sure to troubleshoot your analyzer before moving on.
Be sure to collect at least 1mL of whole blood sample when running sample
in the open vial sampling mode; at least 2mL of whole blood sample in the
autoloading mode.
Be sure to prepare at least 1mL of control when running control in the open
vial sampling mode; at least 2mL of control in the autoloading mode.
Be sure the sample ID, rack No., tube No, and measuring mode entered are
completely the same with the information of the sample to be analyzed.
C-5
Appendices
Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
When removing the SRV tray, do not loosen the thumbscrew fixing the
sample probe; otherwise air may enter the sample probe and unreliable
results may be obtained.
To avoid damage to the components of the analyzer, close the front cover
gently.
The SRV is so fragile that any knock or drop may damage it. Exercise
caution when disassembling/assembling or cleaning the SRV. Do not loosen
or bend the tiny steel tubes at sides of the SRV.
After the analyzer is turned off, wait at least 30 seconds to release the
pressure and vacuum accumulated in the pneumatic lines. Do not perform
any maintenance or replacing procedure immediately after you turn off the
analyzer.
The sample probe should be completely separated from the probe wipe
when the SRV is disassembled. Otherwise, the probe may be deformed or
the probe wipe may be damaged.
When the SRV is disassembled, reagent may leak from the tubes. Place a
dry cloth or tissue under the SRV to absorb any reagent.
Do not use too much force to pull tubes on sides of the SRV when
disassembling the SRV. Otherwise, the tubes may be disconnected and the
leakage may be caused.
Be sure the sample probe is inserted through the probe wipe, and the probe
wipe is placed back to the original position when the analyzer is turned off.
Otherwise, the probe wipe will be stuck and cannot work after the analyzer
is turned on.
After the SRV tray is reassembled, check whether the thumbscrew on the
top of the sample probe is loose. If so, tighten it. Otherwise, it can cause air
to come into the probe and lead to unreliable analysis result.
Once reagents spill on the surface of the analyzer, wipe them off with a
C-6
Appendices
When disassembling, cleaning and reassembling the probe wipe, do not use
too much force. Otherwise, the probe wipe of the open vial sampling unit
will be damaged.
Disconnect the tubes by pinching the ends of connects, swaying them while
pulling them outward. Do not use too much force while disconnecting the
tubes. Otherwise, the probe wipe of the open vial sampling unit will be
damaged.
Position the metal knob between the two stoppers when reassembling the
rotor valve. Otherwise, the SRV may not function.
C-7
Appendices
C.5 Notes
NOTE
This equipment must be operated by skilled/trained medical professionals.
The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that
require additional studies.
Do not adjust the pneumatic relief valve. Contact Mindray customer service
department or your local distributor if necessary.
Please select the desired input language properly. Improper input language
may lead to confused screen display.
For bi-directional LIS mode, the “Entry of next sample ID” is set to “Manual
entry” and cannot be changed.
Disable the blood sensor when running samples with extreme low
concentrations, for example, samples of dialysis patients.
Store and use the reagents as instructed by instructions for use of the
reagents.
When you have changed the diluent or lyses, run a background to see if the
results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
After installing a new container of reagent, keep it still for a while before use.
Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.
For any reagent, the entered expiration date should be either the expiration
C-8
Appendices
If the impact printer is connected when the analyzer is on, you need to
restart the analyzer to use the printer.
Be sure to check the printout if the print format is changed or a new printing
title is entered.
If “Print ref. range” is selected, then the “Print ref. range flags” will be
selected by default and unavailable for you to edit. The ref. range and ref.
range flags (“H” or “L”) will be printed in the report together.
If you want to deselect “Print ref. range flags” when “Print ref. range” is
selected (i.e. print the report with ref. ranges but without ref. range flags),
please contact Mindray customer service department or your local
distributor.
If “Print ref. range” is not selected (i.e. print the report without ref. ranges),
then you can select whether to print the ref. range flags (“H” or “L”) in the
report at will.
To avoid personal injury and analyzer damage, setting the autoloader stop
conditions is recommended.
Be sure that the symbology and the character length set match the actual
bar-code in use, and it is suggested not select the symbology not used on
site, which may cause misreading of barcodes.It is suggested not select
more than one symbology and the “Unlimited number of digits” box at the
same time, which may cause misreading of barcodes.
When setting flag rules, the lower limit of the flag message indicating the
increase of cells (e.g. Leucocytosis, Neutrophilia, Lymphocytosis and
Thrombocytosis) shall not be lower than the upper limit of the flag message
indicating the decrease of cells (e.g. Leucopenia, Neutropenia,
Lymphopenia, and Thrombocytopenia).
You can delete the only one piece of the code information each time.
You can delete only one piece of user information each time.
You should only use the Mindray-specified reagents. Store and use the
C-9
Appendices
The bottom right of the Login dialog box is the button displaying the current
input language (default: English) of the pop-up keyboard. You can CLICK it
to switch to another language.
Since the pneumatic unit is controlled by the analyzer, the power switch of
the pneumatic unit can be kept in the ON position (I).
The system opens different function for the user according to the user level.
The user level depends on the user name and the password when the user
logs in.
In the open-vial mode, the flickering yellow icon indicates that the analyzer
is ready to aspirate the next sample.
Running sample with the background abnormal error present will lead to
unreliable results.
For the whole blood samples to be used for WBC differential, you shall store
them at the room temperature and run them within 8 hours after collection.
Be sure to mix any sample that has been prepared for a while before running
it.
In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 15 parameters, 2 histograms
and 1 scattergram. In the “CBC+5DIFF” mode, the analyzer counts blood
cells and 5-part differentiates WBCs; the results include 25 parameters, 2
histograms, 2 scattergrams and another 4 RUO parameters.
WBC differential results obtained in the predilute mode are for reference
only.
C-10
Appendices
You can also aspirate 120μL of diluent by pipette into the tube.
After mixing the capillary sample with the diluent, be sure to wait 3 minutes
before running the sample.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Repeat steps 7 and 8 and you can prepare more prediluted samples.
For bi-directional LIS mode, the measurement mode, as well as the sampling
and blood mode will be obtained by inquiring the LIS system (the
measurement mode must be obtained by inquiring the LIS system, while the
sampling and blood mode can be absent in the LIS system), so you don’t
need to set the “CBC” or “CBC+5DIFF” mode. You can set the sampling and
blood mode, however, if the mode obtained from LIS is different from the
current mode, a dialog box of “Error! Keep LIS and analyzer in the same
mode!” will prompt when you run the sample.
If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.
If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.
For bi-directional LIS mode, only the sampling mode and blood mode will be
displayed in the “Current” field, and you don’t need to set the “CBC” or
“CBC+5DIFF” measurement mode.
You can edit the “Checker” box at the review screen only after the analysis
is finished.
The predefined operating mode and sample ID are default values in the
“Work list”. Modify them as instructed if necessary.
Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be imprecise.
When the aspiration is done, remove the control vial/sample tube only when
the sample probe is out of the tube.
The default ref. range is “General” if you run a sample immediately after the
operating mode setting. After the analysis, the analyzer will flag, if any,
C-11
Appendices
During the analysis, CLICK the “Work list” button to enter the information
for the next sample.
If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.
CLICK the “>>>“ button to scroll to the "RUO Screen" button. CLICK it for
RUO parameters.
After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1, stay the same or be cleared according to the
setup. See Heading 5.2.1 Settings for the setup method.
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
You can not perform the autoloading analysis if the “Bi-directional LIS”
mode is selected but no barcode scanner is configured.
For bi-directional LIS mode, the measurement mode, as well as the sampling
and blood mode will be obtained by inquiring the LIS system (the
measurement mode must be obtained by inquiring the LIS system, while the
sampling and blood mode can be absent in the LIS system), so you don’t
need to set the “CBC” or “CBC+5DIFF” mode. You can set the sampling and
blood mode, however, if the mode obtained from LIS is different from the
current mode, this sample will be included in “Samples in wrong mode in
LIS” in the “Summary” dialog box popping up after counting (for more about
the “Summary” dialog box, see 6.9.3 Running the samples).
The first default rack number is the number of the first detected sample
carrier after the analysis is started.
You can reedit or delete the information of the sample erroneously analyzed.
The system sequences the “Rack - Tube” in ascending order. If the “New” or
“Edit” operation is performed, the system will again sequence the No. in the
work list.
Do not enter repeated sample ID, rack No. and tube No simultaneously.
After the sample information is changed, the status of “Error” will become
C-12
Appendices
The measuring modes of the same batch samples are the same.
During the autoloading process, if the entry rule of next sample ID is set as
“Auto-increment” and the starting sample ID ends with a character, all
sample IDs in the autoloading cycle will stay the same.
If the racks for the samples to be run of the same batch exceed the capacity
of the autoloader, you need to timely add the rest racks to the right tray of
the autoloader and take away the racks on the left tray of the autoloader.
When no record in the work list completely meets the detected sample ID,
rack No., tube No. and measuring mode of the sample, the actually detected
information will be written into the work list as the information of the
sample.
If several labels are stuck to one tube, or the label is misplaced, peeled or
wrinkled, it may cause autoloading error. To avoid such error, the notes
below shall be followed:
Do not use barcode label which is easily peeled to prevent the label from
peeling.
Ensure that the tube with barcode label can be taken out from and placed
back to the rack easily.
You can select up to 500 samples at a time. If the selected results are more
than 500, the first 500 results selected will be taken.
In the “Selected” dialog box, without entering any number in the “From” box
and the “To” box, you can CLICK the “Deselected” button directly to
C-13
Appendices
After exiting the “Table Review” screen, the sample results of the selected
database will be cleared and the sample results of the sample database will
not be highlighted any longer.
Once you leave the “Table Review” screen, the sample results saved in the
search database will be cleared.
If any selected result contains invalid parameter value (s), the Mean, SD and
CV% of that parameter(s) will also be non-numeric (***). The system will
automatically set the lower limit, mean value and the upper limit in the trend
graph to be within the preset “General” reference range by the operator. See
Chapter 5 Customizing the Analyzer Software for how to set the reference
range.
You can only calculate the percentage of samples with reexam prompts
when you log in as an administrator.
CLICK the "RUO Screen" button to browse the analysis results of RUO
parameters.
You can only edit the analysis results when you log in as an administrator.
If you edit the result of a parameter, all other related parameters will change
accordingly. The system will display the ref. range flags and suspect flags
based on the edited results.
For samples analyzed in the CBC mode, you can edit the WBC, RBC, HGB,
HCT and PLT results; for samples analyzed in the CBC+5DIFF mode, you
can edit the WBC, Neu%, Lym%, Mon%, Eos%, RBC, HGB, HCT and PLT
results, and you should calculate manually to ensure that the sum of the
differential percentages is 100%.
Once a result is edited, even if it has been checked, the edited result will be
flagged with an "E" after it, and each related result that changed accordingly
will be flagged with an "e".
You can not edit background results. When you click the "Edit Result"
button at the "Graph Review" screen of background results, a dialog box
will pop up, prompting that background results can not be edited.
You can only restore analysis results when you log in as an administrator.
C-14
Appendices
The analyzer stores the original analysis results of the previous 1000 edited
samples.
The “Del. Ref. Value” button appears gray when there are saved expected
results and limits at the “Setting” screen. You need to delete all the L-J
analysis results at the current QC file before editing. See Heading 8.2.3
Reviewing L-J analysis results for how to delete the results.
Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.
Refer to the instructions for use of the control for information on the lot
number, expiration date, open vial stability days, expected results and limits.
The entered expiration date should be either the expiration date printed on
the labeling or the open vial expiration date, whichever is earlier. The open
vial expiration date is calculated as follows: the date that vial is opened +
the open vial stability days.
In case that the expected result and limit for a certain parameter are not
predefined, you can enter them after you get the analysis result
(administrator level).
After one or more groups of L-J analysis results are obtained, the
administrator can modify or delete the expected results and limits of
parameters, or get preset values (see 8.2.1 Editing L-J settings for details). If
the expected result and limit of a certain parameter are changed, they will be
highlighted in yellow.
If there are analysis results corresponding to the current file No. and lot No.,
the “Import File” button will be grayed out to disable the import function.
The expected results entered should be within the display range; the limits
should be less than the expected results and neither of them should be “0”.
Otherwise, the entry is invalid.
The settings can be saved only when both the expected result and limit are
valid.
The settings can be saved only when both the expected result/limit and L/H
limits of sample validity setup are valid.
Be sure to use the Mindray- specified controls. Using controls other than
the specified will lead to misleading results.
C-15
Appendices
Refer to the instructions for use of the controls for how to store and use
them.
After mixing the control with the diluent, be sure to wait 3 minutes before
running the control.
Be sure to run the prediluted control within 30 minutes after the mixing.
Be sure to mix any control that has been prepared for a while before running
it.
When the built-in barcode scanner is not used, you can run only one control
each time.
The QC file No. of the same batch of controls must be the same.
If less than 3 within-control results of L-J QC graph are saved, the “Mean”,
“SD” and “CV%” of every parameter are all empty.
After every deletion, the following results will sequentially move forward
and their No. will be refreshed.
The expected results vary with areas. It is recommended they are obtained
by calculating the averages of at least 500 random patient samples.
The “Del. Ref. Value” button appears gray when there are saved expected
results and limits at the “Setting” screen. You need to delete all the X-B
analysis results before editing. See 8.3.3 Reviewing X-B analysis results for
how to delete the results.
Random samples are required for the X-B analysis. In case of known
samples of a particular type (oncology, neonatal and so forth) that will
seriously interfere with the X-B results, deactivate the X-B analysis.
CLICK the “Close” radio button of “X-B QC” to deactivate the X-B analysis.
The default setting is “OFF”.
C-16
Appendices
If you have logged in as a common user, you can only view the current
calibration factors without changing them. To calibrate the analyzer, first log
out and then re-log in as the administrator.
Refer to the instructions for use of the calibrator for information on the lot
number, expiration date, open vial stability days and reference values.
The entered expiration date should be either the expiration date printed on
the labeling or the open vial expiration date, whichever is earlier. The open
vial expiration date is calculated as follows: the date that vial is opened +
the open vial stability days.
You can delete only one group of data by clicking the “Delete” button once
on the screen.
You cannot delete the calculated CVs and calibration factors at the “Blood”
count screen.
Keep the reagent containers from any strong vibration or collision with
other objects. Otherwise unreliable error messages may be reported.
While replacing the diluent container, be sure to follow the following steps:
1) install the supporting board as shown inFigure 10-3; 2) insert the cap
assembly (shown in Figure 10-4) into the diluent container vertically, and
then secure the cap. Otherwise unreliable error messages may be reported.
C-17
Appendices
Reassemble the SRV tray by facing the side with the groove up.
Make sure no dust should be found in the holes and grooves and on the
surfaces after the cleaning.
The valve contact surfaces must be damp when the SRV is reassembled.
Be sure the sampling valve, rotor valve and rear fixed valve of the SRV
attach well after the reassembly.
If the pressure is adjusted too high, you should adjust it to the lowest level
before readjusting it to the desired level.
If abnormal power failure occurs after the analysis starts, remove the rack(s)
manually, open the front cover to check for fallen test tube and take it out, if
any.
If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.
To change the time when to start the auto-sleep, see Heading 5.3.1 Settings
for details.
If it is time for auto-sleep, some current operations will pause. When the
analyzer is in the auto-sleep status, you can continue the operations.
If you need to use a USB extension cable, be sure that the model and length
of the cable are as specified in this manual and only use it to connect the
USB drive and the analyzer.
1.0×1012/L≤RBC≤8.0×1012/L 50fL≤MCV≤150fL
20pg≤MCH≤40pg 240g/L≤MCHC≤440g/L
All the entries should be numbers with only one decimal point.
Once the validity range is changed, the previous results will not be used in
the QC calculation as valid results, for example, if 20 valid samples are
C-18
Appendices
needed for the X-B QC calculation, when you change the validity range after
10 groups of valid sample results have been acquired, these 10 groups of
results will be discarded, and only valid sample results generated
afterwards will be used in the QC calculation.
C-19
Appendices
Parameter flags
If parameter is followed by an “H” or “L”, it means the analysis result has exceeded the
upper or lower limit of the reference range, but still within the display range.
If you see *** as opposed to the result, it means the result is either invalid or out of the
display range. If the WBC result of the sample is less than 0.5 109/L or greater than 250
109/L, this analyzer will not perform the differential analysis and all the related
parameter values will be non-numeric (***).
WBC Flag
Abnormal
Flag Meaning Judgment criterion
Leucocytosis High WBC analysis results WBC > 18.0×109/L
Leucopenia Low WBC analysis results WBC < 2.5×109/L
Neutrophilia High neutrophils analysis NEUT# > 11.0×109/L
results
Neutropenia Low neutrophils analysis NEUT# < 1.0×109/L
results
Lymphocytosis High lymphocytes analysis LYMPH# > 4.0×109/L
results
Lymphopenia Low lymphocytes analysis LYMPH# < 0.8×109/L
results
Monocytosis High monocytes analysis MONO# > 1.5×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L
results
Basophilia High basophils analysis BASO# > 0.2×109/L
results
C-20
Appendices
Suspect
Flag Meaning Judgment criterion
Asp. Abn./Abn. Sample? The aspiration may be Results of primary
abnormal, or the sample itself parameters are severely low
may be abnormal simultaneously
WBC Abn. ? WBC numbers of BASO and WBC numbers of BASO and
DIFF channels are DIFF channels are
inconsistent. The sample inconsistent.
may be abnormal, or the
analyzer may be abnormal.
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
Left Shift? Left shift may exist. Many scatter-points exist in
the left shift area of the
scattergram.
Immature Cell? Immature cells may exist. The proportion of immature
cells is greater than 2.5%.
Abn./Atypical Lym? Abnormal lymphocytes or The proportion of
atypical lymphocytes may abnormal/atypical
exist. lymphocytes is greater than
2%.
RBC Lyse Resist? RBC hemolysis may be Scatter-points are thick
incomplete. between the lymphocytes
and ghost cells areas of the
scattergram.
Remark For the "WBC Abn." suspect flag, if the analyzer determines
that it is resulted from fragile WBCs, or the WBC result in the
predilute mode is between 0.5×109/L and 2.0×109/L, the
analysis result will be displayed; otherwise, the analysis result
shows "***".
RBC/HGB Flag
Abnormal
Flag Meaning Judgment criterion
RBC Abn. Distribution Abnormal RBC scattergram RBC scattergram is
abnormal.
Anisocytosis Sizes of RBCs are dissimilar RDW-SD>64 or RDW-CV>22
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Erythrocytosis Increased RBCs RBC# > 6.50×1012/L
Anemia Anemia HGB < 90g/L
C-21
Appendices
Suspect
Flag Meaning Judgment criterion
RBC or HGB Abn.? Results of RBC or HGB may Analyzing and comparing
be inaccurate results of HGB and RBC
HGB Abn./Interfere? HGB results may be Calculating and comparing
abnormal, or interference special analysis parameters
may exist
PLT Flag
Abnormal
Flag Meaning Judgment criterion
Thrombocytosis PLTs increase PLT > 600×109/L
Thrombocytopenia PLTs decrease PLT < 60×109/L
PLT Abn Distribution PLT histogram distribution is PLT histogram is abnormal.
abnormal.
Suspect
Flag Meaning Judgment criterion
PLT Clump? PLT clump may exist. Calculating and comparing
special analysis parameters
If you see any points fallen outside the control range, do the following steps until the problem is
solved. If all the steps have failed, contact Mindray customer service department or your local
distributor for assistance.
1. Check the screen for error messages. Refer to Chapter 11 Troubleshooting Your
Analyzer for solutions to any displayed error messages.
C-22
Appendices
1. Check the screen for error messages. Refer to Chapter 11 Troubleshooting Your
Analyzer for solutions to any displayed error messages.
4. Run a control.
C-23
D Communication
D.1 Glossary
Analyzer end: the BC-5800 analyzer which sends analysis results and supports bi-directional
LIS inquiry.
LIS end: the receiver end of communication which receiveds analysis results and responds to
inquiry messages.
Uni-directional LIS communication: including the communication of sample analysis results
and L-J QC data.
Bi-directional LIS communication: including the communication of worklist inquiry data and
worklist inquiry results.
D.2 Introduction
The BC-5800 can transmit the sample data and QC data to an external computer (a host)
through its network port, and inquire the host for worklist information. The analyzer end
supports both the 15ID and HL7 communication protocols This section gives detailed
discussion about the setup of transmission parameter and the data transmission format, etc.,
therefore, providing detailed information for the software engineers to program and for the user
to conveniently perform transmission.
D-1
Appendices
D-2
Appendices
D.4.1 Grammar
Protocol data package is the smallest unit of the transmission. Every transmission shall meet
the requirements of constructing a complete protocol data package, regardless of the
quantities of the data.
Message: a complete data package is called a message. There are three description
fields:
MS: Message start field. MS is the first data unit of all messages.
MD: Message description field. It describes the Message type/meaning.
ME: Message end field. ME is the last data unit of all messages.
Segment: Data segment. One piece of Message data consists of one or more Segment
data. There are two description fields.
Field: Property field. One Segment data consists of one or more field data. There are three
description fields.
For multi-host computer and multi-terminal compatible application and to response the control
flow processing in a fastest way, the following conventions are made.
Except the MS, ME, SE and FE in the protocol description field and the case that the
D-3
Appendices
transmission type is binary data as described, data is transmitted via ASCII text coding.
The string describing the meaning directly is transmitted in MD, SD and FD.
To identify Message from data flow and then identify the combined fields in the Message, we
need to set separation between fields in the protocol. The following shows how to separate
fields.
MD, SD, FD and V in the data package are transmitted by ASCII coding to be compatible with
the protocol field changes. The descriptions in V of data attribute can be transmitted via binary
data only when binary data are described in SD.
When data package and fields inside are transmitted via ASCII coding, the host and the
terminal must share the same character set.
Bi-directional LIS communication only supports utf-8 coding system.
D-4
Appendices
Note:
1. All definitions of SD and FD are transmitted in ASCII coding unless otherwise specified.
3. For graphic data flow, the order and number of FD fields cannot be changed.
SE field
D-5
Appendices
FE field
FD field
D-6
Appendices
D-7
Appendices
coordinate in the
scattergram, y for Y
coordinate and v for the
total particle number in the
position (x, y) of the
scattergram.
Byte binary data flow
(MetadataLen=1). The
contents are a complete
image of BASO scattergram
bitmap (including bitmap
BASOBmpData
head-of-file, palette and
data information). The data
length is related to the
scattergram bitmap size
setup of the main unit.
Byte binary data flow
(MetadataLen=1). The
contents are a complete
image of DIFF scattergram
bitmap (including bitmap
DIFFBmpData
head-of-file, palette and
data information). The data
length is related to the
scattergram bitmap size
setup of the main unit.
Binary data flow of
0 1 2 3 4 … 255
RHistoData 256*1(MetadataLen=1)
Byte
Binary data flow of
0 1 2 3 4 … 255
PHistoData 256*1(MetadataLen=1)
Byte
BloodMode Sample mode
0: Open vial-predilute; 1:
Open vial-whole blood; 2:
Autoloading-whole blood
AnaMode Analysis mode
0: CBC + 5DIFF mode; 1:
CBC mode
BasoTotal Particle total number of
BASO channel
DiffTotal Particle total number of
DIFF channel
WbcTotal WBC total number
D-8
Appendices
D-9
Appendices
D-10
Appendices
Tester Tester
Checker Checker
Remark Remark
CusRec1 Customized field 1
CusRec2 Customized field 2
CusRec3 Customized field 3
CusRec4 Customized field 4
Recheck Flag for samples to be
reexamed; value: "1" or "0";
for communication protocol
higher than 15ID 1.0
FileNo L-J analysis QC file No.
LotNo L-J analysis QC lot No.
Level L-J analysis QC level
0 for low, 1 for normal and 2
for high
ExpDate YYYYMMDD L-J analysis QC expiration
date
SampleID Inquiry sample ID
ST Ok , DENY Returning status
Ok means correct worklist
is obtained by inquiring
DENY means inquiry failed
AnaMode 0, 1 Analysis mode 0 means
CBC+5DIFF
1 means CBC
SD Field
Note: All FD fields corresponding to SD fields are from Table 5 FD field definition.
SD FD Description
FD1 FD2 FD3 FD4 FD5 FD6 FD7 FD8 FD9 White Blood
WBC
Val Low High Unit Flag Mean Range EditFlag HighLowFlag Cell count
Neu# Neutrophils
The same with those of WBC
number
Lymphocytes
Lymph# The same with those of WBC
number
Monocytes
Mon# The same with those of WBC
number
Eosinophils
Eos# The same with those of WBC
number
Bas# The same with those of WBC Basophils
D-11
Appendices
number
Neu% Neutrophils
The same with those of WBC
percentage
Lymphocytes
Lymph% The same with those of WBC
percentage
Monocytes
Mon% The same with those of WBC
percentage
Eosinophils
Eos% The same with those of WBC
percentage
Basophils
Bas% The same with those of WBC
percentage
RBC Red Blood Cell
The same with those of WBC
count
HGB Hemoglobin
The same with those of WBC
Concentration
HCT The same with those of WBC Hematocrit
MCV Mean
The same with those of WBC Corpuscular
Volume
MCH Mean
The same with those of WBC Corpuscular
Hemoglobin
MCHC Mean
Corpuscular
The same with those of WBC
Hemoglobin
Concentration
RDW-CV Red Blood Cell
Distribution
The same with those of WBC Width
Coefficient of
Variation
RDW-SD Red Blood Cell
Distribution
The same with those of WBC Width
Standard
Deviation
PLT The same with those of WBC Platelet count
MPV Mean Platelet
The same with those of WBC
Volume
PDW Platelet
The same with those of WBC Distribution
Width
PCT The same with those of WBC Plateletcrit
ALY# The same with those of WBC Abnormal
D-12
Appendices
Lymphocytes
number
ALY% Abnormal
The same with those of WBC Lymphocytes
percentage
LIC# Large
The same with those of WBC Immature Cells
number
LIC% Large
The same with those of WBC Immature Cells
percentage
Low angle
WBC(Diff)
LasDiff The same with those of WBC
value of gain
calibration
High angle
WBC(Diff)
MasDiff The same with those of WBC
value of gain
calibration
Low angle
WBC(Baso)
LasBaso The same with those of WBC
value of gain
calibration
High angle
WBC(Diff)
MasBaso The same with those of WBC
value of gain
calibration
QC parameter
GranX The same with those of WBC
GRAN-X
QC parameter
GranY The same with those of WBC
GRAN-Y
QC parameter
GranYW The same with those of WBC
GRAN-Y(W)
QC parameter
WBCBAX The same with those of WBC
WBC/BA-X
QC parameter
WBCBAY The same with those of WBC
WBC/BA-Y
P-LCC
parameter; for
P-LCC The same with those of WBC communication
protocol higher
than 15ID 1.0
P-LCR
P-LCR The same with those of WBC
parameter; for
D-13
Appendices
communication
protocol higher
than 15ID 1.0
FD1 FD2 FD3 RBC
RBCHisto
DataLen MetaDataLen RHistoData Histogram
FD1 FD2 FD3
PLTHisto PLT Histogram
DataLen MetaDataLen PHistoData
FD1 FD2 FD3
BASOType BASO type
DataLen MetaDataLen BASOTypeData
FD1 FD2 FD3
BASO BASO data
DataLen MetaDataLen BASOData
FD1 FD2 FD3
DIFFType DIFF type
DataLen MetaDataLen DIFFTypeData
FD1 FD2 FD3
DIFF DIFF data
DataLen MetaDataLen DIFFData
FD1 FD2 FD3 BASO bitmap
BASOBMP
DataLen MetaDataLen BASOBmpData data
FD1 Protocol
ProtocolVer
Val version No.
FD1 FD2 Mode
Mode
BloodMode AnaMode
Ref. range
0: General; 1:
FD1 Male; 2:
SampGroup
Val Female; 3:
Child; 4:
Neonate;
Particle total
FD1 FD2 FD3 FD4 FD5
Total number of
BasoTotal DiffTotal WbcTotal RbcTotal PltTotal
channels
WBC
differential sign
FD1 1 for
WbcSepFlag
Val differential; 0
for
non-differential
FD1 FD2 Discriminators
SepRBCLeft SepRBCRight of histogram
SepLine
FD3 FD4
SepPLTLeft SepPLTRight
D-14
Appendices
Histogram
adjustment
sign
If the
FD1
HistoAdj histogram is
Val
adjusted, the
VAL is 240. If
not, the VAL is
0.
Flag sign
FD1 1 for flag
AlarmFlag
Val exists; 0 for no
flag
FD1 FD2 FD3 FD3 FD4
WLeft WRight WGran WNrbc WBlast
FD5 FD6 FD7 FD8 FD9
WAtl WNeuLow WNeuHigh WLymLow WLymHigh
FD16 FD17 FD18 FD19 FD20
WMonHigh WEosHigh WBasHigh WBCHigh WBCLow
Prompt of
FD21 FD22 FD23 FD24 FD25
AbnormalFlag abnormal
AspirateAbn WBCAbn RDistri RAniso RMicro
sample result
FD26 FD27 FD28 FD29 FD30
RMacro REryth RAgg RUnnormal RAnemia
FD31 FD32 FD33 FD34 FD35
RHypo RTurbi RDimor RIron RRbcHgbAbn
FD36 FD37 FD38 FD39 FD40
PPenia PSis PDistri PAgg PMicro
Time
information of
samples
Including the
FD1 FD2 FD3 FD4
PatTime sample time,
SampTime SendTime TestTime RepTime
sending time,
analysis time
and reporting
time
FD1 FD2 FD3 FD3 FD4
SampleID Name Gender AgeType AgeVal
Basic
FD5 FD6 FD7 FD8 FD9
information of
PatInfo ChargeType SamSourc ChartNo BedNo InsNo
patient
FD10 FD11 FD12 FD13 FD14
samples
Dept Sender Tester Checker Remark
FD15 FD16 FD17 FD18 FD19
D-15
Appendices
D-16
Appendices
Coding data
Special note: To ensure the coding data to be displayed by text, this manual expresses the
delimiters in the communication protocol per the following rules.
For example, the MS field (0x05) will be displayed as “{” in the demonstration data in the
manual. The rest fields and delimiters will be displayed according to the table above.
According to character of the sample data, the demonstration data is listed in the following four
parts: analysis parameter, sample information, patient information and graph information.
Analysis parameter
This section includes start bits, message types and analysis parameters of coding data.
{CTR#WBC:Val,9.55;Low,4.00;High,10.00;Flag,0;Unit,10^9/L;EditFlag,;HighLowFlag,;$Ne
u#:Val,3.00;Low,2.00;High,7.00;Flag,0;Unit,10^9/L;EditFlag,;HighLowFlag,;$Lymph#:Val,2
.63;Low,0.80;High,4.00;Flag,0;Unit,10^9/L;EditFlag,;HighLowFlag,;$Mon#:Val,0.71;Low,0.
12;High,1.20;Flag,0;Unit,10^9/L;EditFlag,;HighLowFlag,;$Eos#:Val,0.34;Low,0.02;High,0.5
0;Flag,0;Unit,10^9/L;EditFlag,;HighLowFlag,;$Bas#:Val,2.87;Low,0.00;High,0.10;Flag,0;Un
it,10^9/L;EditFlag,;HighLowFlag,H;$Neu%:Val,31.5;Low,50.0;High,70.0;Flag,0;Unit,%;Edit
Flag,;HighLowFlag,L;$Lymph%:Val,27.5;Low,20.0;High,40.0;Flag,0;Unit,%;EditFlag,;High
LowFlag,;$Mon%:Val,7.4;Low,3.0;High,12.0;Flag,0;Unit,%;EditFlag,;HighLowFlag,;$Eos%
:Val,3.6;Low,0.5;High,5.0;Flag,0;Unit,%;EditFlag,;HighLowFlag,;$Bas%:Val,30.0;Low,0.0;
High,1.0;Flag,0;Unit,%;EditFlag,;HighLowFlag,H;$RBC:Val,3.95;Low,4.00;High,5.50;Flag,
0;Unit,10^12/L;EditFlag,;HighLowFlag,L;$HGB:Val,114;Low,120;High,160;Flag,0;Unit,g/L
;EditFlag,;HighLowFlag,L;$HCT:Val,37.5;Low,40.0;High,54.0;Flag,0;Unit,%;EditFlag,;High
LowFlag,L;$MCV:Val,95.0;Low,80.0;High,100.0;Flag,0;Unit,fL;EditFlag,;HighLowFlag,;$
MCH:Val,28.9;Low,27.0;High,34.0;Flag,0;Unit,pg;EditFlag,;HighLowFlag,;$MCHC:Val,304
;Low,320;High,360;Flag,0;Unit,g/L;EditFlag,;HighLowFlag,L;$RDW-CV:Val,14.4;Low,11.0;
D-17
Appendices
High,16.0;Flag,0;Unit,%;EditFlag,;HighLowFlag,;$RDW-SD:Val,60.7;Low,35.0;High,56.0;F
lag,0;Unit,fL;EditFlag,;HighLowFlag,H;$PLT:Val,362;Low,100;High,300;Flag,0;Unit,10^9/L
;EditFlag,;HighLowFlag,H;$MPV:Val,12.0;Low,6.5;High,12.0;Flag,0;Unit,fL;EditFlag,;High
LowFlag,;$PDW:Val,14.4;Low,9.0;High,17.0;Flag,0;Unit,;EditFlag,;HighLowFlag,;$PCT:Val
,0.434;Low,0.108;High,0.282;Flag,0;Unit,%;EditFlag,;HighLowFlag,H;$ALY#:Val,0.12;Low
,0.00;High,0.20;Flag,0;Unit,10^9/L;EditFlag,;HighLowFlag,;$ALY%:Val,1.3;Low,0.0;High,2
.0;Flag,0;Unit,%;EditFlag,;HighLowFlag,;$LIC#:Val,0.02;Low,0.00;High,0.20;Flag,0;Unit,1
0^9/L;EditFlag,;HighLowFlag,;$LIC%:Val,0.2;Low,0.0;High,2.5;Flag,0;Unit,%;EditFlag,;Hi
ghLowFlag,;$LasDiff:Val,77.2;Low,***.*;High,***.*;Flag,0;Unit,fL;EditFlag,;HighLowFlag
,;$MasDiff:Val,77.2;Low,***.*;High,***.*;Flag,0;Unit,fL;EditFlag,;HighLowFlag,;$LasBas
o:Val,68.3;Low,***.*;High,***.*;Flag,0;Unit,fL;EditFlag,;HighLowFlag,;$MasBaso:Val,75.
8;Low,***.*;High,***.*;Flag,0;Unit,fL;EditFlag,;HighLowFlag,;$GranX:Val,*;Low,*;High,*
;Flag,0;Unit,;EditFlag,;HighLowFlag,;$GranY:Val,*;Low,*;High,*;Flag,0;Unit,;EditFlag,;Hig
hLowFlag,;$GranYW:Val,*;Low,*;High,*;Flag,0;Unit,;EditFlag,;HighLowFlag,;$WBCBAX:
Val,75;Low,*;High,*;Flag,0;Unit,;EditFlag,;HighLowFlag,;$WBCBAY:Val,68;Low,*;High,*;
Flag,0;Unit,;EditFlag,;HighLowFlag,;$
Sample information
This section includes the following information: sample ID., name, gender, age, age type, bed
No., department, sender, tester, sending time, testing time, etc..
SepLine:SepRBCLeft,49;SepRBCRight,181;SepPLTLeft,5;SepPLTRight,121;$Total:BasoTot
al,17554;DiffTotal,16207;RbcTotal,397;PltTotal,364;$Mode:BloodMode,2;AnaMode,0;$Prot
ocolVer:Val,A;$SampGroup:Val,1;$WbcSepFlag:Val,0;$HistoAdj:Val,0;$AlarmFlag:Val,0;$P
atInfo:SampleID,ABCDEF-0YT-4;Name,NAME;Gender,2;AgeVal,32;AgeType,1;ChartNo,C
HARTNO;BedNo,BEDN11;Dept,DEPT;Sender,DELIVERY;Tester,Li;Remark,REMARK;Re
Check,0;$PatTime:SampTime,2000-07-06 05:00:00;SendTime,2000-07-06
07:00:00;TestTime,2009-06-26
10:38:51;$AbnormalFlag:WLeft,1;WRight,0;WGran,0;WNrbc,0;WBlast,0;WAtl,0;WNeuLo
w,0;WNeuHigh,0;WLymLow,0;WLymHigh,0;WMonHigh,0;WEosHigh,0;WBasHigh,1;WB
CHigh,0;WBCLow,0;AspirateAbn,0;WBCAbn,0;RDistri,0;RAniso,0;RMicro,0;RMacro,0;R
Eryth,0;RAgg,0;RUnnormal,0;RAnemia,0;RHypo,0;RTurbi,0;RDimor,0;RIron,0;RRbcHgbA
bn,0;PPenia,0;PSis,0;PDistri,0;PAgg,0;PMicro,0;$
Graph information
The graph information is transmitted in binary system data directly. The coding rules for BASO
scattergram, DIFF scattergram, RBC histogram and PLT histogram are exactly the same. See
D-18
Appendices
D-19
Appendices
D.5.1 Grammar
Bottom Protocol
TCP/IP is a byte stream protocol which does not provide message boundary. As the top
protocol, HL7 is based on messages, which does not provide any message termination
mechanism. Therefore, HL7 messages use MLLP lower layer protocol (refer to HL7 Interface
Standards Version 2.3.1 for related descriptions) to locate the message boundary.
The messages are transmitted in the following format:
<SB> ddddd <EB><CR>
where,
<SB> = Start Block character (1 byte)
ASCII <VT>, i.e., <0x0B>. Do not confuse with the SOH or STX character in ASCII.
Every HL7 message consists of several segments and ends up with the <CR> character.
Each segment consists of the segment name of three characters and field of changeable
characters, and each field consists of the component and subcomponent. Each message
begins with a MSH segment (including separators for the field, component and
subcomponent).
For example:
MSH|^~\&|BC5800|MINDRAY|||20361231235941||ORU^R01|2|P|2.3.1||||||UNICODE
In this message:
The five characters following "MSH" define the separators to distinguish each field, component
and subcomponent. Although they can be any non-text characters, HL7 standard recommends
the characters in the table below:
Character Meaning
| Field separator
^ Component separator
& Subcomponent separator
D-20
Appendices
~ Repetition separator
\ ESC
The first field of MSH includes every separator. Some field behind are empty because they are
optional and not used by Mindray HL7 interface. Detailed field definition and selection will be
stated in the following contents.
For message of any type, the segments behind MSH appear in the fixed order. The order will
be described in the following contents and the grammar is used to organize the segments
order.
The segment appeared in [] is optional.
The segment appeared in {} can be repeated once or more.
In the HL7 communication, you can see the 4 types of messages: ORU^R01, ACK^R01,
ORM^O01 and ORR^O02. ORU^R01 message and ACK^R01 message are mated for
message communication (communication of analysis results and QC data); ORM^O01
message and ORR^O02 message are mated for Order message communication (worklist
communication).
ORU^R01 message
It is mostly used for the transmission of the test results and QC data.
ORU Observational Results (Unsolicited) Description
MSH Message Header, mandatory, including the communication information of message
No., sending time, message separator and coding method, etc
{
PID Patient demographic information, including patient name, gender, patient ID,
birthday, etc
D-21
Appendices
[PV1] Patient visit information, including patient type, department, bed No. and charge,
etc
{
OBRsample information, including sample No., operator and run time, etc
{[OBX]} test data, including test results and work mode, etc
}
}
ACK^R01 message
ORM^O01 message
Common order message, all the actions related to order basically use the message of this type.
For example, create a new order or cancel an order. Here, the main unit requests LIS to re-fill
the order message.
ORM General Order Message Description
MSH Message Header
{ORC} Common message of Order, including the No. information of the sample inquired
ORR^O02 message
Affirming of the ORM^O01 message. Here, returning the completed information of order (i.e.
worklist).
ORR^O02 General Order Response Message Description
MSH Message header
MSAMessage affirm
[PIDPatient basic information
[PV1]]Patient visit information
{
ORCCommon message of Order, including the sample No.
[
OBRsample information
{[OBX]}Data of other sample information, including work mode, etc.
]
}
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
D-22
Appendices
follows:
1. No.: the HL7 message initiates with the segment name of 3 characters followed by the fields
which separated by separators. "No." refers to the position of the field in the HL7 message
segment.
E.g.:
PID |1 | |7393670^^^^MR|| Joan^JIang ||19950804000000|Female
↑ ↑ ↑
Segment name Field1 Field 3
2. Field name: the logic sense of the field.
3. Data type: the data type based on HL7 standards. See D.5.6 Definitions of HL7 Data
Typesfor 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 separators while analyzing the message segment.
5. Note: notes to the value of the field.
6. Samples: samples of the fields.
MSH
The MSH (Message Header) segment contains basic information of HL7 message including
separators’ value, message type and coding method etc. It is the first field of every HL7
message.
Message example:
MSH|^~\&|BC-5300|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
See Table 12-9 for the definition of each field used in MSH segment.
D-23
Appendices
“BC-5380”.
4 Sending EI 180 Device of sending terminal. If MINDRAY
Facility the main unit sends the
message, the value is
“Mindray”.
7 Date/Time TS 26 Created time of message (in 20361231235925
Of the format of
Message YYYY[MM[DD[HH[MM[SS]]]]]);
adopts the system time.
9 Message CM 7 Message type; in the format of ORU^R01
Type “message type^event type”.
e.g. ORU^R01
10 Message ST 20 Message control ID; be used 2
Control ID to mark a message uniquely.
11 Processing PT 3 Message processing ID P
ID values:
“P”- sample and worklist
searching information;
“D”- QC setup information;
“T” – QC results information;
In Ack messages, it is
consistent with the previously
received message.
12 Version ID VID 60 HL7 version information; the 2.3.1
value is “2.3.1”.
18 Character ID 10 Character set. UNICODE
Set The value is “UNICODE”,
indicating the message is
expressed in the form of a
UTF-8 string.
MSA
The MSA (Message Acknowledgement) segment contains message confirming information. It
is used in bi-directional LIS response messages.
Message example:
MSA|AA|1
See Table 12-10 for definition of the fields used.
D-24
Appendices
PID
The PID(Patient Identification) segment contains the patient basic information.
Message example:
PID|1||CHARTNO^^^^MR||^NAME|||Male
See Table 12-11 for definition of the fields used.
PV1
The PV1 (Patient Visit) segment contains the patient visit information.
Message example:
PV1|1||DEPT^^BEDN11
See Table 12-12 for definition of the fields used.
D-25
Appendices
OBR
The OBR (Observation Request) segment contains the test report information.
Message example:
OBR|1||ABCDEF-0YT-4|00001^Automated Count^99MRC||20000706050000|200906261
03851|||DELIVERY||||20000706070000||||||||||HM||||||||Li
See Table 12-13 for definition of the fields used.
D-26
Appendices
Date/time Date/time
To express the
sampling date and
time.
7 Observation TS 26 Run Time 20090626103851
Date/Time #
10 Collector XCN 60 Sample collector DELIVERY
Identifier * To indicate the
deliverer
13 Relevant ST 300 Relevant clinical
Clinical Info. information.
It can be used as
the clinical
diagnostic
information in the
patient info.
14 Specimen TS 26 Sample received 20000706070000
Received time
Date/Time * To express the
delivery time.
15 Specimen CM 300 Sample source
Source * Its value in HL7
message on the
auto hematology
analyzers:
“BLDV”- Venous
blood
“BLDC”- Capillary
blood
22 Results TS 26 Results
Rpt/Status report/Status
Chng - Change -
Date/Time + Date/Time
To be used as
validating time.
24 Diagnostic ID 10 Diagnostic ID, the HM
Serv Sect ID value is “HM”,
means Hematology.
28 Result Copies XCN 60 Result copies to
To To indicate the
validater.
32 Principal CM 200 Principal result Li
Result interpreter
Interpreter + To be used as
D-27
Appendices
OBX
The OBX(Observation/Result) segment contains the parameter information of each test result.
Message example:
OBX|7|NM|6690-2^WBC^LN||9.55|10*9/L|4.00-10.00||||F
See Table 12-14 for definition of the fields used.
D-28
Appendices
D-29
Appendices
ORC
The ORC(Common Order) segment contains the common information of order.
Message used for example:
ORC|RF||SampleID||IP
See Table 12-15 for definition of the fields used.
D.5.4 Examples
Sample message
MSH|^~\&|BC5800|MINDRAY|||20361231235941||ORU^R01|2|P|2.3.1||||||UNICODE
PID|1||CHARTNO^^^^MR||^NAME|||Male
PV1|1||DEPT^^BEDN11
OBR|1||ABCDEF-0YT-4|00001^Automated
Count^99MRC||20000706050000|20090626103851|||DELIVERY||||20000706070000||||||||
||HM||||||||Li
OBX|1|IS|08001^Take Mode^99MRC||A||||||F
D-30
Appendices
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC+5DIFF||||||F
OBX|4|IS|01002^Ref Group^99MRC||male||||||F
OBX|5|NM|30525-0^Age^LN||32|yr|||||F
OBX|6|ST|01001^Remark^99MRC||REMARK||||||F
OBX|7|NM|6690-2^WBC^LN||9.55|10*9/L|4.00-10.00||||F
OBX|8|NM|704-7^BAS#^LN||2.87|10*9/L|0.00-0.10|H|||F
OBX|9|NM|706-2^BAS%^LN||30.0|%|0.0-1.0|H|||F
OBX|10|NM|751-8^NEU#^LN||3.00|10*9/L|2.00-7.00||||F
OBX|11|NM|770-8^NEU%^LN||31.5|%|50.0-70.0|L|||F
OBX|12|NM|711-2^EOS#^LN||0.34|10*9/L|0.02-0.50||||F
OBX|13|NM|713-8^EOS%^LN||3.6|%|0.5-5.0||||F
OBX|14|NM|731-0^LYM#^LN||2.63|10*9/L|0.80-4.00||||F
OBX|15|NM|736-9^LYM%^LN||27.5|%|20.0-40.0||||F
OBX|16|NM|742-7^MON#^LN||0.71|10*9/L|0.12-1.20||||F
OBX|17|NM|5905-5^MON%^LN||7.4|%|3.0-12.0||||F
OBX|18|NM|26477-0^*ALY#^LN||0.12|10*9/L|0.00-0.20||||F
OBX|19|NM|13046-8^*ALY%^LN||1.3|%|0.0-2.0||||F
OBX|20|NM|10000^*LIC#^99MRC||0.02|10*9/L|0.00-0.20||||F
OBX|21|NM|10001^*LIC%^99MRC||0.2|%|0.0-2.5||||F
OBX|22|NM|789-8^RBC^LN||3.95|10*12/L|4.00-5.50|L|||F
OBX|23|NM|718-7^HGB^LN||114|g/L|120-160|L|||F
OBX|24|NM|787-2^MCV^LN||95.0|fL|80.0-100.0||||F
OBX|25|NM|785-6^MCH^LN||28.9|pg|27.0-34.0||||F
OBX|26|NM|786-4^MCHC^LN||304|g/L|320-360|L|||F
OBX|27|NM|788-0^RDW-CV^LN||14.4|%|11.0-16.0||||F
OBX|28|NM|21000-5^RDW-SD^LN||60.7|fL|35.0-56.0|H|||F
OBX|29|NM|4544-3^HCT^LN||37.5|%|40.0-54.0|L|||F
OBX|30|NM|777-3^PLT^LN||362|10*9/L|100-300|H|||F
OBX|31|NM|32623-1^MPV^LN||12.0|fL|6.5-12.0||||F
OBX|32|NM|32207-3^PDW^LN||14.4||9.0-17.0||||F
OBX|33|NM|10002^PCT^99MRC||0.434|%|0.108-0.282|H|||F
OBX|34|NM|10003^GRAN-X^99MRC||*||*-*||||F
OBX|35|NM|10004^GRAN-Y^99MRC||*||*-*||||F
OBX|36|NM|10005^GRAN-Y(W)^99MRC||*||*-*||||F
OBX|37|NM|10011^WBCBAX^99MRC||75||*-*||||F
D-31
Appendices
OBX|38|NM|10012^WBCBAY^99MRC||68||*-*||||F
OBX|39|NM|10007^GainLasDiff^99MRC||77.2|fL|***.*-***.*||||F
OBX|40|NM|10008^GainMasDiff^99MRC||77.2|fL|***.*-***.*||||F
OBX|41|NM|10009^GainLasBaso^99MRC||68.3|fL|***.*-***.*||||F
OBX|42|NM|10010^GainMasBaso^99MRC||75.8|fL|***.*-***.*||||F
OBX|43|IS|12010^Basophilia^99MRC||T||||||F
OBX|44|IS|17790-7^WBC Left Shift?^LN||T||||||F
OBX|45|NM|15051^RBC Histogram. Left Line^99MRC||49||||||F
OBX|46|NM|15052^RBC Histogram. Right Line^99MRC||181||||||F
OBX|47|NM|15053^RBC Histogram. Binary Meta Length^99MRC||1||||||F
OBX|48|NM|15057^RBC Histogram. Total^99MRC||397||||||F
OBX|49|ED|15050^RBC Histogram.
Binary^99MRC||^Application^Octer-stream^Base64^……RBC Histogram Binary
Data……||||||F
OBX|50|NM|15111^PLT Histogram. Left Line^99MRC||5||||||F
OBX|51|NM|15112^PLT Histogram. Right Line^99MRC||121||||||F
OBX|52|NM|15113^PLT Histogram. Binary Meta Length^99MRC||1||||||F
OBX|53|NM|15117^PLT Histogram. Total^99MRC||364||||||F
OBX|54|ED|15100^PLT Histogram.
Binary^99MRC||^Application^Octer-stream^Base64^……PLT Histogram Binary
Data……||||||F
OBX|55|NM|15203^WBC DIFF Scattergram. Meta len^99MRC||4||||||F
OBX|56|NM|15204^WBC DIFF Scattergram. Meta count^99MRC||8789||||||F
OBX|57|ED|15202^WBC DIFF Scattergram. BIN type
data^99MRC||^Application^Octer-stream^Base64^……DIFF Scattergram type
data……||||||F
OBX|58|ED|15201^WBC DIFF Scattergram.
BIN^99MRC||^Application^Octer-stream^Base64^……DIFF Scattergram Binary Data……
||||||F
OBX|59|NM|15253^Baso Scattergram. Meta Len^99MRC||4||||||F
OBX|60|NM|15254^Baso Scattergram. Meta count^99MRC||7946||||||F
OBX|61|ED|15252^Baso Scattergram. BIN type
data^99MRC||^Application^Octer-stream^Base64^……BASO Scattergram type
data……||||||F
OBX|62|ED|15251^Baso Scattergram.
BIN^99MRC||^Application^Octer-stream^Base64^……BASO Scattergram Binary
D-32
Appendices
Data……||||||F
Every time a sample result is received, a sample response message composed of two
message segments (MSH and MSA) will be sent. 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 of 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 2.
MSH|^~\&|LIS||||20361231235956||ACK^R01|1|P|2.3.1||||||UNICODE
MSA|AA|2
QC message
The content of the QC message differs from that of the sample analysis result: the MSH-11
value of the QC message is Q which indicates that it is a QC message
QC response message
The only difference between the QC response message and the analysis result response
message is that the MSH-11 value of the QC response message is Q.
A bidirectional LIS inquiry message contains a sample ID. After the LIS received the inquiry
message, it will search for the corresponding patient and sample information to provide a
response.
The inquiry message is composed of two message segments: MSH and ORC. The MSH
segment is almost the same with that of the analysis result, except that the MSH-9 value is
ORM^O01. The ORC-3 field should be filled with the receiver code (in this case, the sample ID;
where in the following sample, it is SampleID1). Note that in the autoloading analysis, if there
is a barcode scan error while sending an inquiry message, the sample ID will be “Invalid”.
An example of the inquiry message is shown as follows:
MSH|^~\&|BC5800|MINDRAY|||20081120174836||ORM^O01|4|P|2.3.1||||||UNICODE
ORC|RF||SampleID1||IP
When the LIS received an inquiry message, it needs to send back an inquiry response
message. The first two message segments of the inquiry response message are MSH and
MSA. The MSH-9 field (indicating the type of the segment) is filled with ORR^O02, while the
MSA segment should be filled up as shown in the following example of the inquiry response
D-33
Appendices
message. If the LIS gets searching results for the inquiry, 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 an inquiry response message with searching results, in which the ORC-1
value is AF, and ORC-2 is the filter (the sample ID). Note that the OBR-2 field indicates the
sample ID, which should be the same value as in the ORC-2 field; otherwise, the message will
be regarded as incorrect.
An example of the inquiry response message with searching results is shown as follows:
MSH|^~\&|LIS||||20081120174836||ORR^O02|1|P|2.3.1||||||UNICODE
MSA|AA|4
PID|1||ChartNo^^^^MR||^FName||19810506|NT
PV1|1|nk^^Bn4|||||||||||||||||NewCharge
ORC|AF|SampleID1|||
OBR|1|SampleID1||||20060506||||tester|||Diagnose
content....|20060504||||||||20080821||HM||||Tester||||Checker
OBX|1|IS|08001^Take Mode^99MRC||A||||||F
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC||||||F
OBX|4|IS|01002^Ref Group^99MRC||XXXX||||||F
OBX|5|NM|30525-0^Age^LN||1|hr|||||F
OBX|6|ST|01001^Remark^99MRC||remark content....||||||F
An example of the inquiry response message with no search result is shown as follows, where
the MSA-2 field indicates the result of the response. In this example, the MSA-2 value is “AR”,
indicating the inquiry was rejected; if it is “AE", then there is an error in the inquiry process.
MSH|^~\&|LIS||||20081120175238||ORR^O02|1|P|2.3.1||||||UNICODE
MSA|AR|9
D-34
Appendices
OBX-6, it contains the unit for the parameter, expressing in the ISO standard.
HL7
Coding
Data Type Name EncodeSys OBX-3 field example
(ID)
(OBX-2)
Other data
08001^Take
Take Mode IS 08001 Take Mode 99MRC
Mode^99MRC
08002^Blood
Blood Mode IS 08002 Blood Mode 99MRC
Mode^99MRC
08003^Test
Test mode IS 08003 Test Mode 99MRC
Mode^99MRC
Age NM 30525-0 Age LN 30525-0^Age^LN
01001^Remark^99M
Remark ST 01001 Remark 99MRC
RC
01002^Ref
Ref Group IS 01002 Ref Group 99MRC
Group^99MRC
05001^Qc
QC Level IS 05001 Qc Level 99MRC
Level^99MRC
01006^ Recheck
Recheck flag IS 01006 Recheck flag 99MRC
flag^99MRC
Analysis results data
WBC NM 6690-2 WBC LN 6690-2^WBC^LN
BAS NM 704-7 BAS# LN 704-7^BAS#^LN
BAS_PER NM 706-2 BAS% LN 706-2^BAS%^LN
NEU NM 751-8 NEU# LN 751-8^NEU#^LN
NEU_PER NM 770-8 NEU% LN 770-8^NEU%^LN
EOS NM 711-2 EOS# LN 711-2^EOS#^LN
EOS_PER NM 713-8 EOS% LN 713-8^EOS%^LN
LYM NM 731-0 LYM# LN 731-0^LYM#^LN
LYM_PER NM 736-9 LYM% LN 736-9^LYM%^LN
MON NM 742-7 MON# LN 742-7^MON#^LN
MON_PER NM 5905-5 MON% LN 5905-5^MON%^LN
ALY NM 26477-0 *ALY# LN 26477-0^*ALY#^LN
ALY_PER NM 13046-8 *ALY% LN 13046-8^*ALY%^LN
LIC NM 10000 *LIC# 99MRC 10000^*LIC#^99MRC
10001^*LIC%^99MR
LIC_PER NM 10001 *LIC% 99MRC
C
RBC NM 789-8 RBC LN 789-8^RBC^LN
HGB NM 718-7 HGB LN 718-7^HGB^LN
MCV NM 787-2 MCV LN 787-2^MCV^LN
MCH NM 785-6 MCH LN 785-6^MCH^LN
MCHC NM 786-4 MCHC LN 786-4^MCHC^LN
D-35
Appendices
D-36
Appendices
D-37
Appendices
Adjusted Mark
PLT 15116^PLT
PLT Histogram.
Histogram ED 15116 99MRC Histogram.
BMP
Bitmap Data BMP^99MRC
DIFF WBC DIFF 15200^WBC DIFF
Scattergram ED 15200 Scattergram. 99MRC Scattergram.
Bitmap Data BMP BMP^99MRC
DIFF 15201^ WBC DIFF
WBC DIFF
Scattergram ED 15201 99MRC Scattergram.
Scattergram. BIN
Binary Data BIN^99MRC
DIFF WBC DIFF 15202^ WBC DIFF
Scattergram ED 15202 Scattergram. BIN 99MRC Scattergram. BIN
Type Data type data type data^99MRC
DIFF 15203^ WBC DIFF
WBC DIFF
Scattergram Scattergram. Meta
NM 15203 Scattergram. 99MRC
Metadata len^99MRC
Meta len
Length
DIFF 15204^ WBC DIFF
WBC DIFF
Scattergram Scattergram. Meta
NM 15204 Scattergram. 99MRC
Metadata count^99MRC
Meta count
Count
BASO Baso 15250^ Baso
Scattergram ED 15250 Scattergram. 99MRC Scattergram.
Bitmap Data BMP BMP^99MRC
BASO 15251^ Baso
Baso
Scattergram ED 15251 99MRC Scattergram.
Scattergram. BIN
Binary Data BIN^99MRC
BASO Baso 15252^ Baso
Scattergram ED 15252 Scattergram. BIN 99MRC Scattergram. BIN
Type Data type data type data^99MRC
BASO 15253^ Baso
Baso
Scattergram Scattergram. Meta
NM 15253 Scattergram. 99MRC
Metadata Len^99MRC
Meta Len
Length
BASO 15254^ Baso
Baso
Scattergram Scattergram. Meta
NM 15254 Scattergram. 99MRC
Metadata count^99MRC
Meta count
Count
Abnormal alarm information
12000^WBC
WBC Abn WBC Abnormal
IS 12000 99MRC Abnormal
scattergram scattergram
scattergram^99MRC
Abnormal WBC Abnormal 12001^WBC
IS 12001 99MRC
WBC histogram Abnormal
D-38
Appendices
Histogram histogram^99MRC
12002^Leucocytosis^
Leucocytosis IS 12002 Leucocytosis 99MRC
99MRC
12003^Leucopenia^9
Leucopenia IS 12003 Leucopenia 99MRC
9MRC
12004^Neutrophilia^9
Neutrophilia IS 12004 Neutrophilia 99MRC
9MRC
12005^Neutropenia^
Neutropenia IS 12005 Neutropenia 99MRC
99MRC
Lymphocytosi 12006^Lymphocytosi
IS 12006 Lymphocytosis 99MRC
s s^99MRC
12007^Lymphopenia^
Lymphopenia IS 12007 Lymphopenia 99MRC
99MRC
12008^Monocytosis^
Monocytosis IS 12008 Monocytosis 99MRC
99MRC
12009^Eosinophilia^9
Eosinophilia IS 12009 Eosinophilia 99MRC
9MRC
12010^Basophilia^99
Basophilia IS 12010 Basophilia 99MRC
MRC
WBC 12011^WBC
IS 12011 WBC Abnormal 99MRC
abnormal Abnormal^99MRC
17790-7^WBC Left
Left Shift? IS 17790-7 WBC Left Shift? LN
Shift?^LN
Immature Imm 34165-1^Imm
IS 34165-1 LN
Granulocyte? Granulocytes? Granulocytes?^LN
Abnormal/Aty 15192-8^Atypical
pical IS 15192-8 Atypical Lymphs? LN Lymphs?^LN
Lymphocyte?
RBC Lyse 34525-6^rstRBC^LN
IS 34525-6 rstRBC LN
Resist?
12012^Erythrocytosis
Erythrocytosis IS 12012 Erythrocytosis 99MRC
^99MRC
RBC 12013^RBC
RBC Abnormal
abnormal IS 12013 99MRC Abnormal
distribution
distribution distribution^99MRC
15150-6^Anisocytosis
Anisocytosis IS 15150-6 Anisocytosis LN
^LN
15198-5^Macrocytes
Macrocytosis IS 15198-5 Macrocytes LN
^LN
15199-3^Microcytes^
Microcytosis IS 15199-3 Microcytes LN
LN
10379-6^RBC Dual
Dimorphologic IS 10379-6 RBC Dual Pop LN
Pop^LN
Anemia IS 12014 Anemia 99MRC 12014^Anemia^99M
D-39
Appendices
RC
15180-3^Hypochromi
Hypochromia IS 15180-3 Hypochromia LN
a^LN
HGB 12015^HGB
IS 12015 HGB Interfere 99MRC
Abn/Interfere? Interfere^99MRC
PLT Abnormal PLT Abnormal 12016^PLT Abnormal
IS 12016 99MRC
Distribution Distribution Distribution^99MRC
Thrombocytos 12017^Thrombocytos
IS 12017 Thrombocytosis 99MRC
is is^99MRC
12018^Thrombopenia
Thrombopenia IS 12018 Thrombopenia 99MRC
^99MRC
7796-6^Platelet
PLT Clump? IS 7796-6 Platelet Clump? LN
Clump?^LN
12020^ Right
Right Shift IS 12020 Right Shift 99MRC
Shift^99MRC
Sample 12021^ Sample
IS 12021 Sample Abnormal 99MRC
Abnormal Abnormal^99MRC
12022^ RBC
RBC Clump IS 12022 RBC Clump 99MRC
Clump^99MRC
32208-1^
Platelets.small IS 32208-1 Platelets.small LN
Platelets.small^ LN
RBC HGB RBC HGB 12023^ RBC HGB
IS 12023 99MRC
Abnormal Abnormal Abnormal^99MRC
Iron 12024^ Iron
IS 12024 Iron Deficiency 99MRC
Deficiency Deficiency^99MRC
RBC HGB 12025^ RBC HGB
IS 12025 RBC HGB doubt 99MRC
doubt doubt^99MRC
D-40
Appendices
g/L g/L
g/dL g/dL
L/L L/L
mmol/L mmol/L
% %
fL fL
um^3 um3
pg pg
fmol fmol
amol amol
Year (age unit) yr
Month (age unit) mo
Day (age unit) d
Hour (age unit) hr
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
D-41
Appendices
<ID (ST)> ^ <check digit (ST)> ^ <code identifying the check digit scheme employed (ID)> ^ <
assigning authority (HD)> ^ <identifier type code (IS)> ^ < assigning facility (HD)>
ED – Encapsulate Data
EI - Entity Identifier
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID (ST)> ^ <universal ID type (ID)>
FC – Financial Class
HD - Hierarchic designator
FT - Formatted text
This data type is derived from the string data type by allowing the addition of embedded
formatting instructions. These instructions are limited to those that are intrinsic and
independent of the circumstances under which the field is being used.
The value of such a field follows the formatting rules for an ST field except that it is drawn from
a site-defined (or user-defined) table of legal values. There shall be an HL7 table number
associated with IS data types.
The value of such a field follows the formatting rules for an ST field except that it is drawn from
a table of legal values. There shall be an HL7 table number associated with ID data types.
NM - Numeric
PL - Person location
<point of care (IS )> ^ <room (IS )> ^ <bed (IS)> ^ <facility (HD)> ^ < location status (IS )> ^
<person location type (IS)> ^ <building (IS )> ^ <floor (IS )> ^ <location description (ST)>
PT - Processing type
D-42
Appendices
SI - Sequence ID
A non-negative integer in the form of an NM field. The uses of this data type are defined in the
chapters defining the segments and messages in which it appears.
ST – String
TS - Time stamp
In Version 2.3, use instead of the CN data type. <ID number (ST)> ^ <family name (ST)> &
<last_name_prefix (ST) ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR
or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <source table (IS)> ^
<assigning authority (HD)> ^ <name type code (ID)> ^ <identifier check digit (ST)> ^ <code
identifying the check digit scheme employed (ID)> ^ <identifier type code (IS)> ^ <assigning
facility (HD)> ^ <name representation code (ID)>
In Version 2.3, replaces the PN data type. <family name (ST)> ^ <given name (ST)> &
<last_name_prefix (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^
<prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^ <name type code (ID) > ^ <name
representation code (ID)>
The histogram data are transmitted as binary data. In the OBX segment, the value of the data
type field is “ED”; the value of the data is in the form of
“^Application^Octet-stream^Base64^……histogram data……”; “Application" herein indicates
that the data transmitted are application program data, "Octer-stream” is the byte stream type,
and “Base64” indicates the coding method of the data.
The scattergram binary data are transmitted in a similar way.
Scattergram bitmap data communication: in the OBX segment, the value of the data type field
is “ED”; the value of data is in the form of “^Image^BMP^Base64^……scattergram bitmap
data……”. The “Image^BMP^Base64” indicates the bitmap data is of BMP type and coded
based on Base64.
D-43
Appendices
(1) Select the 3 adjacent bytes (i.e. 24 bit) from the data stream to be coded; from left to right,
divide them into 4 groups of 6-bit; then, ASCII string is obtained by mapping as per the
Table 12-18.
Initial data 15H A3H 4BH
Binary data 00010101 10100011 01001011
6-bit group obtained after dividing 000101 011010 001101 001011
Corresponding coding value 5H 1AH 0DH 0BH
Corresponding character F a N L
(2) Repeat the coding of procedure (1) continuously till finish coding the data stream.
When the data left is less than 3 bytes, 0 is used to complement to the right. If the whole 6-bit
group obtained is composed of 0, then it is mapped to the “=” character. When one byte is left,
then the obtained coding string consists of two “=” characters; when two bytes are left, then the
obtained coding string consists of one “=” character. The two cases are demonstrated below:
D-44
Appendices
Corresponding characters C g = =
D-45
P/N: 046-001967-00 (5.0)