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BC 5500 Operation Mannual16pdf PDF
BC 5500 Operation Mannual16pdf PDF
Operator’s Manual
Copyright
© 2005-2007 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2007-12 (Version: 1.6).
Mindray intends to maintain the contents of this manual as confidential information. Disclosure
of the information in this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaption and translation of this manual
in any manner whatsoever without the written permission of Mindray is strictly forbidden.
.
Responsibility on the Manufacturer Party
Contents of this manual are subject to changes without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for
errors contained herein nor 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.
I
the product is used in accordance with the instructions for use.
z Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.
II
Warranty
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.
any Mindray product which has been subjected to misuse, negligence or accident.
any Mindray product from which Mindray's original serial number tag or product
identification markings have been altered or removed.
Return Policy
Return Procedure
In the event that it becomes necessary to return this product or part of this product to Mindray,
the following procedure should be followed:
Return authorization: Contact the Customer Service Department and obtain a Customer
Service Authorization number. This number must appear on the outside of the shipping
container. Returned shipments will not be accepted if the number is not clearly visible. Please
provide the model number, serial number, and a brief description of the reason for return.
Freight policy: The customer is responsible for freight charges when this product is shipped to
Mindray for service (this includes customs charges) .
Return address: Please send the part(s) or equipment to the address offered by the Customer
Service Department.
III
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan,ShenZhen518057, P. R. China,
Tel: +86 755 26582479 26582888
Tel: 0049-40-2513175
Fax: 0049-40-255726
IV
Table of Contents
1
6.5 Entering the “Count” screen................................................................... 6-6
6.6 Sample Collection and Handling.......................................................... 6-10
6.7 Open Vial Sampling Analysis ............................................................... 6-14
6.8 Closed Tube Sampling Analysis........................................................... 6-29
6.9 Autoloading Analysis ............................................................................ 6-43
6.10 Liquid Saver ......................................................................................... 6-65
6.11 Shutdown ............................................................................................. 6-66
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-5500 operation manual, which is shipped with your
BC-5500 AUTO HEMATOLOGY ANALYZER and contains reference information about the
BC-5500 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.
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-5500 Chapter 2 Understanding
Your Analyzer
learn about the hardware and software of the BC-5500 Chapter 2 Understanding
Your Analyzer
learn about how the BC-5500 works Chapter 3 Understanding the
System Principles
learn about the installation requirements of the BC-5500 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-5500 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-5500 Chapter 9 Using the
Calibration Programs
learn about how to maintain/service the BC-5500 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-5500 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-5500 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 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]; or
DELETE to move the cursor to the character or digit to the right of the
one you want to delete and press [BackSpace] (or the [←] key
at the upper right corner of the pop-up keyboard).
to CLICK and hold the mouse down while dragging the scroll
DRAG SCROLL BAR bar until the desired information is displayed; or
to CLICK and rest your finger there while dragging the scroll
bar until the desired information is displayed.
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.
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.
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
z 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 is used for the quantitative determination of the following 23 basic parameters, 4
parameters for research use, 2 histograms and 2 scattergrams of blood samples.
2-2
Understanding Your Analyzer
BC-5500 AUTO HEMATOLOGY ANALYZER consists of the main unit (analyzer), pneumatic
unit and accessories.
2-3
Understanding Your Analyzer
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 2-6 Inside front of the Analyzer(Front Cover Removed, Autoloader or Closed
tube Sampler 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
2-13
Understanding Your Analyzer
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.
2-14
Understanding Your Analyzer
z Do not adjust the pneumatic relief valve. Contact Mindray customer service
department or your local distributor if necessary.
2-15
Understanding Your Analyzer
2.4.1 Screen
After the starting procedure, you will enter the main screen shown in Figure 2-11. CLICK any
icon to enter the desired function screen.
2-16
Understanding Your Analyzer
CLICK the “Count” icon at the main screen to enter the “Count” screen shown in Figure 2-12.
Title area
The Title area displays the title of the current screen, which, in case of Figure 2-12, is “Count”.
CLICK this area and the help information of the “Count” screen will appear.
2-17
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.
z 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.
2-18
Understanding Your Analyzer
EN CN FR DE IT ES RU PT TR
z Please select the desired input language properly. Improper input language
may lead to confused screen display.
6. System time
2-19
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.
2-20
Understanding Your Analyzer
Because the analyzer, reagents (diluent, rinse, lyses, probe cleanser and E-Z cleanser),
controls, and calibrators are components of a system, performance of the system depends on
the combined integrity of all components. You should only use the Mindray-specified reagents
(see Appendix B Specifications), which are formulated specifically for the fluidic system of
your analyzer in order to provide optimal system performance. Do not use the analyzer with
reagents from multiple suppliers. In such use, the analyzer may not meet the performance
specified in this manual and may provide unreliable results. All references related to reagents
in this manual refer to the reagents specifically formulated for this analyzer.
Each reagent package must be examined before use. Inspect the package for signs of leakage
or moisture. Product integrity may be compromised in packages that have been damaged. If
there is evidence of leakage or improper handling, do not use the reagent.
z Store and use the reagents as instructed by instructions for use of the
reagents.
z When you have changed the diluent, cleansers or lyses, run a background
to see if the results meet the requirement.
z Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
z After installing a new container of reagent, keep it still for a while before use.
2.5.1 Reagents
M-50D Diluent
It applies to Mindray 5-part differential hematology analyzer.
M-50LEO(I) Lyse
M-50LEO(I) Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks
down red blood cell walls. It 4-differentiates WBCs.
M-50LEO(II) Lyse
M-50LEO(II) Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks
down red blood cell walls. It 4-differentiates WBCs.
2-21
Understanding Your Analyzer
M-50LH Lyse
M-50LH Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks down
red blood cell walls to determine the HGB.
M-50LBA Lyse
M-50LBA Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks
down red blood cell walls to analyze WBCs and basophils.
M-50 Cleanser
M-50 Cleanser cleaner applies to Mindray 5-part differential hematology analyzer. It is an
isotonic, cleaning solution formulated to clean the fluidic lines and maintain the analyzer daily.
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.
2-22
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, closed-tube 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 closed-tube
sampling mode and autoloading mode, the analyzer can process only whole blood samples.
If you are to analyze a whole blood sample in the autoloading mode or closed-tube sampling
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.
2.992mL of diluent
60µL
1.994mL of diluent
3-3
Understanding the System Principles
3-4
Understanding the System Principles
120µL of diluent
1:4 dilution
8.3µL
2.992mL of diluent
60µL
2.94mL 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%+Bas% .
By analyzing the BAS 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
3-14
Understanding the System Principles
PLT (109/L) is measured directly by counting the platelets passing through the aperture.
MPV
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
3-15
Understanding the System Principles
3.7 Wash
3-16
4 Installing Your Analyzer
4.1 Introduction
Your analyzer is tested before it is shipped from the factory. International symbols and special
handling instructions tell the carrier how to treat this electronic instrument. When you receive
your analyzer, carefully inspect the carton. If you see any signs of mishandling or damage,
contact Mindray customer service department or your local distributor immediately.
4-1
Installing Your Analyzer
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, cleansers, lyses,
pneumatic unit and waste containers.
z Before turning on the analyzer, make sure the input voltage meets the
requirements.
Running temperature: 10 ℃ - 40 ℃
4-2
Installing Your Analyzer
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.
4-3
Installing Your Analyzer
4-4
Installing Your Analyzer
4.3.2 Reagents
z 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.
z 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.
Connect the reagent lines as shown in Figure 4-2. Place lyses on the countertop, and the
diluent, cleanser and waste container below the countertop. Be sure to keep all reagent lines
isolated from anything electrical.
4-5
Installing Your Analyzer
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-5500 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.
1. CLICK the “Date” box and a dialog box shown in Figure 5-3 will pop up.
5-3
Customizing the Analyzer Software
2. CLICK the arrows of the month and the year respectively to select the desired month and
year.
4. CLICK the “OK” button to close the dialog box and refresh the system date. CLICK the
“Cancel” button to close the dialog box without saving the changes.
If the year selected is out of the range of 2000 – 2036, a dialog box shown in Figure 5-4 will
pop up when you close the date setting dialog box.
CLICK the “OK” button to close the dialog box and reselect the year within the range.
5-4
Customizing the Analyzer Software
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 5-5 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 5-6.
5-5
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
by a USB keyboard. The default setting is “Open”.
Two ID setup methods for new samples are provided for the open-vial/close-tube 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 “Manual entry” is selected, when there is a new sample to be run,
the default next ID is empty.
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.
z Disable the blood sensor when running samples with extreme low
concentrations, for example, samples of dialysis patients.
z The blood sensor only works in the closed-tube sampling and autloloading
modes.
5-6
Customizing the Analyzer Software
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 5-8 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.
Reagents
z 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, LH lyse and
cleanser at the “Reagent” screen.
At the “Setup” screen, CLICK the “Reagent” button to enter the screen shown in Figure 5-9.
5-7
Customizing the Analyzer Software
1. CLICK the box of the desired reagent and a dialog box shown in Figure 5-10 will pop up.
The date displayed at the screen is the current system date.
5-8
Customizing the Analyzer Software
2. CLICK the arrows of the month and the year respectively to select the desired month and
year. CLICK the desired number to select the desired day.
3. CLICK the “OK” button to close the dialog box and refresh the reagent expiration date.
CLICK the “Cancel” button to close the dialog box without saving the changes.
4. If the year selected is out of the range of 2000 – 2036, a dialog box shown in Figure 5-11
will pop up when you close the date setting dialog box. CLICK the “OK” button to close
the dialog box and reselect the year within the range.
If an external barcode scanner is connected, you can CLICK the “Barcode scanner” check
box shown in Figure 5-12 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.
5-9
Customizing the Analyzer Software
z 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 5-13 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. 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.
5-10
Customizing the Analyzer Software
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 5-15 will
pop up.
5-11
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 5-16 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 5-17.
5-12
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.
5-13
Customizing the Analyzer Software
5.3 Administrator
When you log in as an administrator, the “Setup” screen will be shown as Figure 5-18.
5.3.1 Settings
At the “Setup” screen, CLICK the “RBC count time” button to enter the screen shown in
Figure 5-19.
5-14
Customizing the Analyzer Software
The valid count time ranges from 8.0 to 18.0 seconds. The default setting is 10.0 seconds.
Enter the desired numbers in the “RBC count time” box. The analyzer will have one decimal
automatically.
The valid delay ranges from 4.0 to 7.0 seconds. The default setting is 5.5 seconds.
Enter the desired numbers in the “Start delay” box. The analyzer will have one decimal
automatically.
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 5-20 will pop up, prompting “Invalid input, exist?”.
5-15
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 5-21 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. 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
5-22.
5-16
Customizing the Analyzer Software
The default expected results of each parameter are displayed on the screen, 12 parameters a
screen. You can DRAG SCROLL BAR 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.
2. DRAG SCROLL BAR , CLICK the “H limit” or “L limit” of the parameter you want to
customize.
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 5-23 will pop up,
prompting “Invalid input, exist?”.
5-17
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 5-24 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.
5-18
Customizing the Analyzer Software
**.* mmol/L /
**.** fmol /
MCHC **** g/L Default
***.* g/dL /
***.* mmol/L /
HCT **.* % Default
.*** L/L /
At the “Setup” screen, CLICK the “Ref. unit” button to enter the screen shown in Figure 5-25.
5-19
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 5-26 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.
z 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 5-27.
5-21
Customizing the Analyzer Software
The analyzer provides four print formats in the pull-down list: 23 paras with H&S, 23 paras
without H&S, 23 paras compact and 13 paras with H. The default format is 23 paras with H&S.
z 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, yo ucan enter the desired number
(1 - 9) into the “Copies” field. The default number is 1.
Auto-print
If the auto-print function is on, the analyzer can automatically print the analysis results when
the results are shown at the “Count” screen.
CLICK “On” to activate the auto-print function; CLICK “Off” to deactivate it.
Print flag
You can select whether to print out the flag in the report.
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 5-28 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.
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 5-29.
Enter the legal addresses in the “IP address(I)”, “Subnet mask(U)” and “Default gateway(D)”
boxes respectively.
Auto-communication
5-23
Customizing the Analyzer Software
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
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 5-31 will pop up.
5-24
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.
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 5-32.
If the MCV results of most calibration or QC runs deviate from the expected result by 6%, you
need to follow the rule below to change the RBC gain to adjust the MCV results.
Assume the expected MCV result is 90.0fL and the obtained MCV result is 82.0fL.
Then
ExpectedMCV 90.0
× 100%= × 100% = 109.8%
ActualMCV 82.0
At the “Gain” screen, CLICK the current value of the “RBC” and enter the new value so that
5-25
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 5-33 will
pop up, prompting “Invalid input, exit?”.
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 5-34 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.
5-26
Customizing the Analyzer Software
Code
To facilitate the operation, you can set some simple codes for frequently used names of
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 5-35.
The created code and the name of the department or sender will be displayed at the screen,
10 codes a screen. If out of 10 codes are created, DRAG SCROLL BAR to view the rest
codes.
CLICK the “Dept.” or “Sender” radio button. If you have selected the “Sender”, CLICK the
“New” button and a dialog box shown in Figure 5-36 will pop up. Enter the desired information
in the “Code” and “Name” box. If you have selected the “Dept”, CLICK the “New” button and a
dialog box shown in Figure 5-37 will pop up. Enter the desired information in the “Code” and
“Dept.” box.
5-27
Customizing the Analyzer Software
If you have selected the “Dept.”, CLICK the “New” button and a dialog box shown below will
pop up. Enter the desired information in the “Code” and “Dept.” box.
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 5-38 will pop up.
5-28
Customizing the Analyzer Software
Enter the new information in the corresponding box. CLICK the “OK” button to save the
change. A dialog box of “Modification succeed!” shown below will pop up. 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 5-40 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.
5-29
Customizing the Analyzer Software
z You can delete the 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
5-41.
You can set here when to start the auto-protect procedure after the relevant fluidic operation
stops. Enter the desired time ranging from 15 to 30 minutes into the “Standby interval” box.
You can check here the accumulated runs from the last time the cleanser cleaning procedure
or the SRV cleaning procedure was conducted and the required number of runs to trigger the
auto-maintenance procedure again.
To exit the “Auto-protect” screen, CLICK any other button at the left of the screen or any button
5-30
Customizing the Analyzer Software
at the bottom. If the data entered are out of the valid range, a dialog box shown in Figure 5-42
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 5-43 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
5-44.
5-31
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. A dialog box shown in Figure 5-45 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.
5-32
Customizing the Analyzer Software
Autoloader (optional)
Entering the “Autoloader” screen
At the “Setup” screen, CLICK the “Autoloader” button to enter the screen shown in Figure
5-46.
You can set conditions to stop the autoloader at the “Autoloader” screen.
z To avoid personal injury and analyzer damage, setting the autoloader stop
conditions is recommended.
5-33
Customizing the Analyzer Software
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.
To exit the “Autoloader” 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.
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.
5-34
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.
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 5-49.
CLICK the radio button of the desired symbology and enter the character length in the “digits”
box. The character length of the first 4 symnologies is valid ranging from 1 to 15, while the
character length of the ITF is valid ranging from the even numbers of 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.
z Be sure that the symbology and the character length set match the actual
bar-code.
5-35
Customizing the Analyzer Software
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 5-50 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 5-51 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.
5-36
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.
5-37
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.
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 5-54 will pop up.
CLICK “Yes” to confirm the deletion and close the dialog box. CLICK “No” to abort the deletion
5-38
Customizing the Analyzer Software
z 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 5-55 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 5-56 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 5-57.
5-39
Customizing the Analyzer Software
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.
5-40
6 Operating Your Analyzer
6.1 Introduction
This chapter provides step-by-step procedures for operating your analyzer on a daily basis. A
flow chart indicating the common daily operating process is presented below.
Initial Checks
Power on
Daily Quality
Control
Sample
Collection and
Handling
Run Samples
Shutdown
6-1
Operating Your Analyzer
z 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.
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.
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.
6-2
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.
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.
6-3
Operating Your Analyzer
z Since the pneumatic unit is controlled by the analyzer, the power switch of
the pneumatic unit can be kept in the ON position (I).
z 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.
z If user switching is necessary, CLICK the “Logout” icon at the “Main” screen.
Enter the desired user name and the password into the popup dialog box
and CLICK the “OK” button to log in.
6-4
Operating Your Analyzer
Before running any samples, run the controls. See Chapter 8 Using the QC Programs for
details.
6-5
Operating Your Analyzer
At the “Main” screen, CLICK the “Count” icon to enter the “Count” screen shown in Figure
6-3.
z 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”.
CLICK it and the help information of the “Count” screen will appear.
6-6
Operating Your Analyzer
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.
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
for on.
6-7
Operating Your Analyzer
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 CN FR DE IT ES RU PT TR
z 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(or
CT-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
appear if the result exceeds the normal background. Refer to Appendix B Specifications for
normal background of parameters.
6-8
Operating Your Analyzer
z 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.
6-9
Operating Your Analyzer
z 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
closed-tube sampling mode and autoloading mode.
6-10
Operating Your Analyzer
z For the whole blood samples to be used for WBC differential or PLT count,
you shall store them at the room temperature and run them within 8 hours
after collection.
z If you do not need the PLT, MCV and WBC differential results, you can store
the samples in a refrigerator (2℃ - 8℃) for 24 hours. You need to warm the
refrigerated samples at room temperature for at least 30 minutes before
running them.
z 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.
6-11
Operating Your Analyzer
z 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.
z 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 Heading 5.2.1 Settings for the
setup method.
z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.
z 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.
6-12
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.
z You can also aspirate 120µL of diluent by pipette into the tube.
z After mixing the capillary sample with the diluent, be sure to wait 3 minutes
before running the sample.
z Be sure to run the prediluted samples within 30 minutes after the mixing.
z Be sure to mix any sample that has been prepared for a while before running
it.
6-13
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.
z 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.
z 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 Heading 5.2.1 Settings for the
setup method.
z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
6-14
Operating Your Analyzer
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the count results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.
z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.
z 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.
6-15
Operating Your Analyzer
z 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.
z You can edit the “Tester” box at the review screen only after the analysis is
finished.
z The previous operating mode and sample ID are default values in the “Work
list”. Modify them as instructed if necessary.
z 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.
z 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 Heading 5.2.1 Settings for the
setup method.
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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 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 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).
6-17
Operating Your Analyzer
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
“Tester” box or SELECT the desired name from the “Tester” 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.
6-18
Operating Your Analyzer
z The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
z The sample probe should be kept away from the tube bottom, when the
probe is aspirating sample. Otherwise, the aspirated volume may be
imprecisely.
z The probe tip should not contact the sample tube. Otherwise, the blood may
spill.
z 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”.
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Operating Your Analyzer
At the “Count” screen shown in Figure 6-9, 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.
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.
z During the analysis, CLICK the “Work list” button to enter the information for
the next sample.
z If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
6-20
Operating Your Analyzer
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.
z 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.
z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.
z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See
Heading 5.2.1 Settings for the setup method.
At the “Count” screen shown in Figure 6-10, 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
6-21
Operating Your Analyzer
z During the analysis, CLICK the “Mode” button or the “Work list” button to
select the operating mode for the next sample.
z 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.
z 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.
z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.
z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See
Heading 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 whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 109/L, this analyzer will not perform the differential analysis and all the related
6-22
Operating Your Analyzer
WBC Flag
Abnormal
Flag Meaning Judgment criterion
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
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# > 1.0×109/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
6-23
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 two 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
abnormal, or interference special analysis parameters
may exist
6-24
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
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 × √ × ×
Monocytosis × √ × ×
6-25
Operating Your Analyzer
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 *.** *.**
NEU,EOS *.** *.**
NEU,BASO *.** *.**
6-26
Operating Your Analyzer
z 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
6-11 will pop up.
2. CLICK the “Copy” button to copy the information of the last sample to the current work list,
6-27
Operating Your Analyzer
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 Heading 6.7.3
Running the samples.
Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually, provided
you have the administrator password. See Chapter 7 Reviewing Sample Results for details.
CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.
6-28
Operating Your Analyzer
1. CLICK the “CT-WB” radio button in the “Work mode” dialog box.
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.
z 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.
6-29
Operating Your Analyzer
setup method.
z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the count results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.
z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.
z 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 a dialog box shown in Figure 6-13
will pop up. Enter the work list information in the box for the next sample to be run.
6-30
Operating Your Analyzer
z 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.
z You can edit the “Tester” box at the review screen only after the analysis is
finished.
z The previous operating mode and sample ID are default values in the “Work
list”. Modify them as instructed if necessary.
z 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.
6-31
Operating Your Analyzer
CLICK the “WB” radio button in the current mode. 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).
6-32
Operating Your Analyzer
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
“Tester” box or SELECT the desired name from the “Tester” 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.
“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.
6-33
Operating Your Analyzer
z The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
z 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 6-14, do as follows to run whole blood samples.
6-34
Operating Your Analyzer
1. Be sure the “Mode” of the “Next sample” is “Closed-Whole blood” and the analysis
status icon is green.
2. CLICK the “Open door” button to open the sample compartment door.
3. Load the mixed sample to the tube holder and close the door.
5. When the analysis is finished, the result will be displayed on the screen. The sample
compartment door will automatically open and the sample tube can be removed. The
analyzer will be ready for the next analysis.
z During the analysis, CLICK the “Mode” button or the “Work list” button to
select the operating mode for the next sample.
z 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.
z 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.
z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.
z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See
Heading 5.2.1 Settings for the setup method.
z If abnormal power failure occurs after the analysis starts, open the front
cover to check for fallen test tube and take it out, if any.
Print
CLICK the “Print” button at the bottom of the screen to print the analysis results for the current
sample.
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Operating Your Analyzer
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 whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 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
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
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
6-36
Operating Your Analyzer
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.
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.
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
6-37
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
CT-WB
Cell Differential Flag
CBC CBC+5DIFF
WBC Abn × √
6-38
Operating Your Analyzer
Left Shift? × √
Immature Cell? × √
Abn./Atypical Lym? × √
Leucocytosis √ √
Leucopenia √ √
Neutrophilia × √
Neutropenia × √
Lymphocytosis × √
Lymphopenia × √
Monocytosis × √
Eosinophilia × √
Basophilia × √
HGB Abn./Interfere? √ √
Anisocytosis √ √
Microcytosis √ √
RBC/HGB
Macrocytosis √ √
Erythrocytosis √ √
Anemia √ √
Hypochromia √ √
Diamorphologic √ √
PLT Clump? √ √
Thrombocytosis √ √
6-39
Operating Your Analyzer
Thrombocytopenia √ √
Small PLT √ √
Parameters 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 “*.**” invalid result
z 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
6-15 will pop up.
6-40
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 Heading 6.8.3
Running the samples.
Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually, provided
you have the administrator password. See Chapter 7 Reviewing Sample Results for details.
CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.
6-41
Operating Your Analyzer
6-42
Operating Your Analyzer
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 “Int.
barcode” button and the ID for the next sample will be entered automatically.
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.
5. CLICK the “OK” button to save the change and return to the “Count” screen.
z You can not perform the autoloading analysis if the “Bi-directional LIS”
mode is seleted but without the barcode scanner.
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Operating Your Analyzer
LIS” mode. Thus, if the “AL-WB” mode is selected in the “work mode” box
in “Bi-directional LIS” mode, the “Int. barcode” button is selected as default.
z 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.
z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the count results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.
z The default first rack number is the number of the first detected sample
carrier after the analysis is started.
z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.
z 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 a dialog box shown in Figure 6-18
will pop up.
6-44
Operating Your Analyzer
CLICK the “New” button and a dialog box shown in Figure 6-19 will pop up. You can enter the
work list information of the sample to be run into the dialog box.
6-45
Operating Your Analyzer
z You can edit the “Tester” box at the review screen only after the analysis is
finished.
CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.
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.
You can load up to 5 racks at once. Each sample carrier has 10 tube positions. 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”.
z The number of empty tube positions of the same sample carrier shall be
within the setting. See Chapter 5 Customizing the Analyzer software for how
to set the setting.
z 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.
z Do not enter repeated sample ID, rack No., tube No and measuring mode
simultaneously.
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Operating Your 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.
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).
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Operating Your Analyzer
To enter the name of the person who sent the sample for analysis, enter the name into the
“Tester” box or SELECT the desired name from the “Tester” 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
“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 in the work list. 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.
z 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 6-20 will pop up. As up to 200
samples can be analyzed at the same batch, the dialog box will prompt you the maximum
sample information to be copied currently.
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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. 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
6-21 will pop up.
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Operating Your Analyzer
CLICK the desired radio button and then CLICK the “OK” button to confirm the deletion.
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.
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Operating Your Analyzer
z The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
z 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.
z 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”.
z The measuring modes of the same batch samples are the same.
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Operating Your Analyzer
If the built-in barcode scanner is not clicked, run the sample instructed as follows.
1. Be sure the “Mode” of the “Next sample” is “AL-WB”, the built-in barcode scanner is not
clicked 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.
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. You can load up to 5
racks at once.
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. After all samples are analyzed, all the racks come to the left tray of the autoloader.
Remove them safely.
If the built-in barcode scanner is clicked, run the sample instructed as follows.
1. Be sure the “Mode” of the “Next sample” is “AL-WB”, the built-in barcode scanner is
clicked and the analysis status icon is green.
3. Place the tubes into the corresponding tube positions as shown in Figure 6-23.
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Operating Your Analyzer
Figure 6-23
4. 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. You can load up to 5 racks at once.
5. CLICK the “Start Count” button at the “Count” screen. The analyzer will start the analysis
automatically.
6. 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.
7. After all samples are analyzed, all the racks come to the left tray of the autoloader.
Remove them safely.
z If “Invalid” appears on the sample ID box, it means the scan is invalid. You
can enter the sample ID again when reviewing sample results. See Chapter 7
Reviewing Sample Results for details.
z You can reedit or delete the information of the sample erroneously analyzed.
z 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.
z 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.
z If the samples to be run of the same batch need more than 5 racks, 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.
z 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.
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Operating Your Analyzer
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 following dialog box
will pop up.
Figure 6-24
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.
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Operating Your Analyzer
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 whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 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
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
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
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Operating Your Analyzer
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.
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.
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
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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 6-6 How the flags of Abnormal Blood Cell Differential or Morphology
AL-WB
Cell Differential Flag
CBC CBC+5DIFF
WBC Abn × √
Left Shift? × √
Immature Cell? × √
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Operating Your Analyzer
Abn./Atypical Lym? × √
Leucocytosis √ √
Leucopenia √ √
Neutrophilia × √
Neutropenia × √
Lymphocytosis × √
Lymphopenia × √
Monocytosis × √
Eosinophilia × √
Basophilia × √
HGB Abn./Interfere? √ √
Anisocytosis √ √
Microcytosis √ √
RBC/HGB
Macrocytosis √ √
Erythrocytosis √ √
Anemia √ √
Hypochromia √ √
Diamorphologic √ √
PLT Clump? √ √
Thrombocytosis √ √
Thrombocytopenia √ √
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Operating Your Analyzer
Small PLT √ √
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 “*.**” invalid result
z When the PLT value is less than 100 × 109 / L, a manual count by the
microscope is recommended.
Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually, provided
you have the administrator password. See Chapter 7 Reviewing Sample Results for details.
CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.
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Operating Your Analyzer
In the autoloading mode, the system provides a work list shown in .Figure 6-25, to preassign
the information such as patient name and age before sample analysis. The work list also
presents the current analysis status.
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 DRAG SCROLL BAR up
and down/left and right to review the sample records.
The measuring modes consist of CBC and CBC+5DIFF. The analysis status includes “Ready”,
“Analysing” and “Error”. The default ref. range is “General”. You can modify it if necessary.
Sample records in the work list very from whether built-in barcode scanner is used and
whether preassigned entries are available in the work list.
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Operating Your Analyzer
If you start the analysis immediately after the operating mode setting, the system will write into
the work list the corresponding record, which “State” changes from “Ready” to “Analysing”.
After the analysis, the sample record and results will be saved to the sample database, and the
sample record will disappear from the work list. The sequent samples are handled in the same
way.
z When the detected tube No. of the first sample is not the same with that
saved in the “Work mode” dialog box, the detected tube No. of the first
sample, and the sample ID, rack No. and measuring mode saved in the
“Work mode” dialog box will be written into the work list as the information
of the sample.
If you start the analysis after you enter the work list information into the work list, the system
will order the sample records ascendingly based on the “Rack - Tube” (eg. “1-1” is before
“1-2”). If sample records have the same “Rack - Tube”, the system will order them ascendingly
based on the “Sample ID”. During the analysis, the “State” in the work list will change into
“Analysing”. After the analysis, the sample record and results will be saved to the sample
database, and the sample record will disappear from the work list. The sequent samples are
handled in the same way.
z 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 you start the analysis immediately after the operating mode setting, the system will write into
the work list the corresponding record, which “State” changes from “Ready” to “Analysing”.
After the analysis, the sample record and results will be saved to the sample database, and the
sample record will disappear from the work list. The sequent samples are handled in the same
way. The sample ID of sequent samples will base on the scanning, the rack No.-tube No. will
automatically increase by 1 based on the last sample respectively, and the measuring mode
keeps the same with that of the last sample.
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Operating Your Analyzer
z When the detected tube No. or sample ID of the first sample is not the same
with that saved in the “Work mode” dialog box, the detected tube No. and
sample ID of the first sample, and the rack No. and measuring mode saved
in the “Work mode” dialog box will be written into the work list as the
information of the sample.
If you start the analysis after you enter the work list information into the work list, the system
will order the sample records ascendingly based on the “Rack - Tube” (eg. “1-1” is before
“1-2”). If sample records have the same “Rack - Tube”, the system will order them ascendingly
based on the “Sample ID”. During the analysis, the “State” in the work list will change into
“Analysing”. After the analysis, the sample record and results will be saved to the sample
database, and the sample record will disappear from the work list. The sequent samples are
handled in the same way.
z 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.
z Blood, scratches and powder from gloves reduces bar-code read rate. Keep
the bar-code label free of blood, scratches and powder from gloves to
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Operating Your Analyzer
To ensure the correct barcode can be read, you must place labels right on the region X as
shown in Figure 6-26.
z The bars on the label must be parallel to the stopper. Otherwise, the scanner
may not read it.
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Operating Your Analyzer
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Operating Your Analyzer
z To change the time when to start the liquid saver, see Heading 5.3.1 Settings
for details.
z At the screens of “Mechanical”, “Circuit” and “Valve”, the analyzer will not
enter the liquid saver status.
z If it is time for liquid saver, some current operations will pause. When the
analyzer is in the liquid saver status, you can continue the operations.
To cancel the liquid saver, press the aspirate key and a dialog box of “Restoring from Saving,
please wait…” will pop up. After the liquid saver is canceld, the dialog box will close
automatically.
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Operating Your Analyzer
6.11 Shutdown
CLICK the “Shutdown” button at the “Main” screen and the shutdown dialog box shown in
Figure 6-28 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.
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Operating Your Analyzer
6-67
7 Reviewing Sample Results
7.1 Introduction
The analyzer automatically saves analysis results. Totally 40,000 results can be saved,
including 23 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 Heading
7.2.2 Selecting/Deselecting sample results and Heading 7.2.3 Search for particular a sample
(s) results 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
z 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 line of the desired sample result. The selected sample results will be
highlighted as the sample “4” shown in Figure 7-2.
Once the sample result is deselected, the highlight will be canceled, as the sample “4” shown
in Figure 7-3.
7-3
Reviewing Sample Results
Example 1: To select sample results of positions 1 – 8 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 7-4 will pop up.
2. ENTER “1” in the “From” box and “8” 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 7-5 to view
7-4
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 7-6 will pop up.
2. CLICK the “All” button to save all sample results to the selected database, and enter the
7-5
Reviewing Sample Results
“Table Review” screen of the selected database shown in Figure 7-7 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 7-8 will pop up.
7-6
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 7-9.
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.
z 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.
z 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.
7-7
Reviewing Sample Results
and overwrite the last results. Maximum 500 results can be saved into the search database.
CLICK the “Search” button and a dialog box shown in Figure 7-10 will pop up.
CLICK the desired search condition button under the “keyword” to select or deselect search
condition. The selected condition will be ticked.
z You can select up to 500 samples 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” button, then CLICK “Male”, “Female” or “Unknown” radio button to select
the patient sex.
7-8
Reviewing Sample Results
CLICK the “Name” button and enter the patient name in the “Name” box.
CLICK the “Date” button. 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, 2006 and Jul. 1st, 2006.
CLICK the “From” button and CLICK the box behind it. The dialog box shown in Figure 7-11,
will pop up. CLICK the desired date (Jun. 1st, 2006) and CLICK the “OK” button to confirm the
starting date. CLICK the box behind “To” to enter the desired date (Jul. 1st, 2006) in the same
way to set the ending date for search.
CLICK the “Dept.” button and SELECT the desired department from the “Dept.” pull-down
list.
7-9
Reviewing Sample Results
CLICK the “Bed No.” button and enter the patient bed number in the “Bed No.” box.
CLICK the “Chart No.” button and enter the patient chart number in the “Chart No.” box.
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.
7-10
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.
z 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. The sample result found will be marked with an arrow at the head of the
line.
7-11
Reviewing Sample Results
CLICK the desired sample result and it will be marked with an arrow at the head of the line.
CLICK the “Edit” button and a dialog box shown in Figure 7-15 will pop up.
7-12
Reviewing Sample Results
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
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
“Tester” box or SELECT the desired name from the “Tester” pull-down list (if there are
previously saved names in the list).
7-13
Reviewing Sample Results
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 “Tester” pull-down list (if there are previously saved
names in the list). If the name of the tester is unavailable in the list, CLICK the “Sign” button to
the right of the “Tester” box. The login dialog box shown in Figure 7-16 will pop up.
Enter the name and password (administrator level) of the tester respectively into the “User
name” and “Password” boxes. CLICK the “OK” button to return to the Editing work list
information dialog box. The tester’s name will automatically appear in the “Tester” 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.
7-14
Reviewing Sample Results
∑x i
Mean= i=1
n
∑ (X − Mean )
2
i
SD =
n −1
SD
CV% = × 100
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis.
To check the reproducibility of the selected sample result, CLICK the “CV” button to enter the
“Calculate CV” screen shown in Figure 7-17.
7-15
Reviewing Sample Results
z 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
z 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.
For every parameter,the three numbers to the right of the trend graph are defined and
calculated as follows:
∑x i
Mean= i=1
n
∑ (X − Mean )
2
i
SD =
n −1
SD
CV% = × 100
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis.
Browse data
The 6 parameters are displayed in 2 screens. You can DRAG SCROLL BAR up and down to
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Reviewing Sample Results
switch screens. At each screen, the saved results are sequentially displayed in the trend graph,
the latest on the utmost left. If information cannot be displayed in one screen, DRAG SCROLL
BAR to scroll the screen.
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.
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.
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Reviewing Sample Results
1. CLICK the “DELETE” button and a dialog box shown in Figure 7-20 will pop up.
2. CLICK the “Current Record”, “Selected Record” or “All Records” radio button for
desired sample results.
3. CLICK the “DELETE” button and a dialog box shown in Figure 7-21 will pop up.
4. CLICK the “OK” button to close the dialog box and delete the desired sample results.
1. CLICK the “Print” button and a dialog box shown in Figure 7-22 will pop up.
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Reviewing Sample Results
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
the desired sample results.
4. CLICK the “Print” button and a dialog box shown in Figure 7-23 will pop up.
5. CLICK “Yes” to perform the print and close the print dialog box.
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Reviewing Sample Results
7.2.10 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 7-24 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.
4. To cancel the transmission, CLICK the “Com.” button again and the “Com.” dialog box will
pop up.
5. CLICK the “Stop” button and the transmission will stop after the current transmission is
completed.
To switch to the “Main” screen or the “Count” screen, CLICK the “Main” or “Count” button.
7-21
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 7-25.
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.
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Reviewing Sample Results
z CLICK the “RUO” button to browse the analysis results of RUO parameters.
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.
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Reviewing Sample Results
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 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
“Tester” box or SELECT the desired name from the “Tester” 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)
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Reviewing Sample Results
SELECT the desired name from the “Tester” pull-down list (if there are previously saved
names in the list). If the name of the tester is unavailable in the list, CLICK the “Sign” button to
the right of the “Tester” box. The login dialog box shown in Figure 7-27 will pop up.
Enter the name and password (administrator level) of the tester respectively into the “User
name” and “Password” boxes. CLICK the “OK” button to return to the editing work list
information dialog box. The tester’s name will automatically appear in the “Tester” 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.
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Reviewing Sample Results
z If you have logged in as a common user, you can only view the histograms
without changing them. To adjust the histograms, first log out and then
re-log in as the administrator.
The discriminators of histograms can be adjusted in case you are not satisfied with the result.
The first two discriminators of the RBC histogram are adjustable. Note that if the RBC result is
less than 0.2 or non-numeric (***), the RBC histogram is not adjustable. The first two
discriminators of the PLT histogram are adjustable. Note that if the PLT result is less than 10 or
non-numeric (***), the PLT histogram is not adjustable.
Example: To move the second discriminator of the following RBC histogram to 100fL, follow
the procedure below to do so.
1. CLICK the “Adjustment” button at the “Graph Review” screen and a dialog box shown in
Figure 7-28 will pop up.
3. CLICK the “←” button to move the second line of RBC to 100fL, as shown in Figure 7-29.
7-26
Reviewing Sample Results
4. CLICK the “OK” button to save the changes and close the dialog box.
To switch to the “Main” screen or the “Count” screen, CLICK the “Main” or “Count” button.
7-27
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.
8-1
Using the QC Programs
Using the “L-J QC” program, you can provide quality control for maximum 23 parameters and
another 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 12 QC files for you to save QC
settings and results. Every QC file can save 3 lot numbers respectively for high, normal and
low controls. The QC file of every lot can save results of maximum 31 QC runs. When the
saved QC results have reached the maximum number, the newest result 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 3 lot numbers respectively for high, normal and low controls.
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).
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Using the QC Programs
CLICK the “Exp. date” box and select the desired date from the calendar.
z 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.
z 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.
z 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.
z 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.
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.
8-4
Using the QC Programs
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.
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 8-5 will pop up when you want to switch screens.
8-6
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.
z The settings can be saved only when both the expected result and limit are
valid.
8-7
Using the QC Programs
z 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.
z Be sure to use the Mindray-specified controls. Using controls other than the
specified will lead to misleading results.
z Refer to the instructions for use of the controls for how to store and use
them.
z After mixing the control with the diluent, be sure to wait 3 minutes before
running the control.
z Be sure to run the prediluted control within 30 minutes after the mixing.
z Be sure to mix any control that has been prepared for a while before running
it.
8-8
Using the QC Programs
z The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
z 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 closed-tube sampling
mode and autoloading mode.
z 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.
z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be imprecise.
z 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.
8-9
Using the QC Programs
a) Be sure the mode is “OV-PD” and the analysis status icon is green.
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 8-7 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 8-8 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.
8-10
Using the QC Programs
z You can also aspirate 120µL of diluent by pipette into the tube.
z If abnormal power failure occurs after the analysis starts, open the front
cover to check for fallen test tube and take it out, if any.
Autoloading mode
z 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.
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Using the QC Programs
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.
z 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
automatically. The analyzer will switch the current screen to the corresponding QC file
according to the lot number scanned.
z 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.
z 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.
z 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.
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Using the QC Programs
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.
8-13
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.
z If the saved within control results of L-J QC graph are less than 3, 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.
For every parameter, its L-J graph can display maximum 31 points.
For every parameter, the upper dash line represents the expected result + limit.
8-14
Using the QC Programs
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= i=1
n
∑ (X − Mean )
2
i
SD =
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.
8-15
Using the QC Programs
The L-J analysis results are sequentially displayed on the graph, the latest on the utmost right
of the graph. DRAG SCROLL BAR up or down 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 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.
1. CLICK the “Calculate” button and a dialog box shown in Figure 8-10 will pop up.
8-16
Using the QC Programs
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
CV% calculated from all within control data will be redisplayed on the right of the QC
graph).
4. CLICK the “Save” button and a dialog box shown in Figure 8-11 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 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.
8-17
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.
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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. DRAG SCROLL BAR up and down 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 “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 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.
8-19
Using the QC Programs
8-20
Using the QC Programs
z 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 8-16 will pop up.
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Using the QC Programs
To transmit all the L-J analysis results, CLICK “Yes”. Otherwise, CLICK “No”.
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.
8-22
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 maximum 500 X-B QC results.
When the saved QC results have reached the maximum number, the newest result will
overwrite the oldest.
2. ENTER means and ranges for the parameters to be included in the X-B analysis into their
respective boxes.
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Using the QC Programs
z The expected results vary with areas. It is recommended they are obtained
by calculating the averages of at least 500 random patient samples.
z 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.
z 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.
z 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.
z CLICK the “Close” radio button of “X-B QC” to deactivate the X-B analysis.
The default setting is “OFF”.
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 8-18 will pop up.
8-24
Using the QC Programs
2. CLICK “Yes” to clear all the expected results (mean) and limits (range) at the current
screen.
Print settings
CLICK the “Print” button to print out the settings of 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 8-19 will pop up when you want to switch screens.
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.
8-25
Using the QC Programs
z The settings can be saved only when both the expected result and limit are
valid.
z 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 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.
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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 maximum 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:
For every parameter,the three numbers to the right of the X-B graph are defined and
calculated as follows:
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Using the QC Programs
∑x i
Mean= i=1
n
∑ (X − Mean )
2
i
SD =
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
of the graph. If the results cannot be view all at once, DRAG SCROLL BAR up or down to
review the preceding or following screen.
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Using the QC Programs
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.
CLICK the “Print” button to print out the current X-B graph.
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.
DRAG SCROLL BAR up and down 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.
8-29
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 8-23 will pop up.
CLICK the “Print” button to print out the X-B table of 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.
8-30
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.
9-1
Using the Calibration Programs
it is the first time this analyzer has been used (usually done by a Mindray-authorized
representative when installing the analyzer).
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 %
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.
z 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.
z 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.
z 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.
9-4
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.
z 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.
9-5
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.
z 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 select the proper expiration date from the date setting
dialog box shown in Figure 9-3. The default setting is the current system time.
9-6
Using the Calibration Programs
7. ENTER the reference values into the “Mean” line for the parameters to be calibrated.
z Refer to the instructions for use of the calibrator for information of the lot
number, expiration date and reference values.
z 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.
9-7
Using the Calibration Programs
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 9-4.
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 9-5 will pop up.
9-8
Using the Calibration Programs
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.
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.
9-9
Using the Calibration Programs
z You can also aspirate 120µL of diluent by pipette into the tube.
z 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.
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 9-7 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 a question mark. 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
9-10
Using the Calibration Programs
CLICK the “Main” or “Count” button at the bottom of the screen and a dialog box shown in
Figure 9-8will 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.
Other operations
Print
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.
9-11
Using the Calibration Programs
z 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.
9-12
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 a question mark. 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).
9-13
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.
9-14
Using the Calibration Programs
Printing
CLICK the “Print” button and the analyzer will automatically perform the printing procedure.
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 9-14will 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.
z Only one group of data can be deleted each time by clicking the “Delete”
button.
z You can not delete the obtained CVs and calibration factors at the “Blood”
screen.
1. Enter the “Main” as the administrator. CLICK the “Count” button to the screen shown in
Figure 9-15.
9-15
Using the Calibration Programs
z 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.
9-16
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.
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.
9-17
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
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.
9-18
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 DRAG
SCROLL BAR 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.
9-19
10 Maintaining Your Analyzer
10.1 Introduction
Preventive and corrective maintenance procedures are required to keep the BC-5500 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.
z Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
z All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
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.
z 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.
z 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.
z Be sure to keep the reagents still for a while before using them.
10-2
Maintaining Your Analyzer
10.2.1 Replacing/Priming
CLICK the “R / P” button at the “Maintain” screen to enter the “R / P” screen.
Diluent
LBA lyse
LH lyse
Cleanser
Diluent cistern
Cleanser cistern
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 “R / P” screen. CLICK “OK” to close it.
10-3
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 “R / P” 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 “R / P” 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 “R / P” screen. CLICK “OK” to close it.
10-4
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 “R / P” 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 “R / P” screen. CLICK “OK” to close it.
Do as follows:
2. The analyzer will start priming and the priming progress will be displayed.
3. Once the priming is complete, a dialog box “Reagent prime finished!” will be displayed at
the “R / P” screen. CLICK “OK” to close it.
Do as follows:
2. The analyzer will start priming and the priming progress will be displayed.
3. Once the priming is complete, a dialog box “Reagent prime finished!” will be displayed at
the “R / P” screen. CLICK “OK” to close it.
10-5
Maintaining Your Analyzer
Do as follows:
2. The analyzer will start priming and the priming progress will be displayed.
3. Once the priming is complete, a dialog box “Reagent prime finished!” will be displayed at
the “R / P” screen. CLICK “OK” to close it.
If the replacement or priming fails, the corresponding dialog box will be displayed at the screen.
CLICK “OK” to close it. Check if the tubing is pinched or disconnected. If so, remove the error
and perform the procedure again. If the procedure fails again, contact Mindray customer
service department or your local distributor for assistance.
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 10-2.
10-6
Maintaining Your Analyzer
z 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.
z 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.
1. CLICK the “WBC bath” button at the “Clean” screen to start the cleaning process.
2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.
3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.
1. CLICK the “RBC bath” button at the “Clean” screen to start the cleaning process.
2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.
3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.
1. CLICK the “Premix bath” button at the “Clean” screen to start the cleaning process.
2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.
3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.
1. CLICK the “HGB bath” button at the “Clean” screen to start the cleaning process.
2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.
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
Do as follows:
1. CLICK the “Open Vial unit” button at the “Clean” screen to start the cleaning process.
2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.
3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.
Do as follows:
1. CLICK the “Autoloader unit” button at the “Clean” screen to start the cleaning process.
2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.
3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.
Do as follows:
1. CLICK the “Remove bubbles” button at the “Clean” screen to start the process.
3. Once the removal is complete, a dialog box of “Remove bubbles finished!” will be
displayed at the “Clean” screen. CLICK “OK” to close it.
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 10-3.
10-8
Maintaining Your Analyzer
Emptying
CLICK the corresponding button to empty the desired bath or cistern.
You should perform this procedure to unclog the RBC aperture or prevent clogging. It functions
by putting high-voltage direct current on both sides of the aperture to clear the protein or dust
in the aperture.
Do as follows:
2. The analyzer will start zapping and the progress will be displayed at the screen.
3. Once the zapping is complete, a dialog box of “Maintenance finished!” will be displayed
at the “Maintenance” screen. CLICK “OK” to close it.
Flushing
After zapping the aperture, perform this procedure to help unclog the RBC aperture or prevent
clogging.
10-9
Maintaining Your Analyzer
Do as follows:
2. The analyzer will start flushing and the progress will be displayed at the screen.
3. Once the flushing is complete, a dialog box of “Maintenance finished!” will be displayed
at the “Maintenance” screen. CLICK “OK” to close it.
Unclogging
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 at the screen.
Do as follows:
1. CLICK the corresponding “RBC bath” button at the “Maintenance” screen. A progress bar
shown in Figure 10-4 will pop up and the maintaining preparation of the RBC bath will start.
2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-5 will pop up.
10-10
Maintaining Your Analyzer
3. Open the front cover of the analyzer and fix it with the stop bar as shown in Figure 10-6.
block groove
stop bar
z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
4. Once the front cover is open, you will see the premix bath and the external shielding box of
the RBC bath and HGB bath shown in Figure 10-7.
10-11
Maintaining Your Analyzer
external
shielding premix bath
box of the
RBC bath
and HGB
bath
5. Use your hand to counterclockwise unscrew the fixing screw as shown in Figure 10-8.
Gently remove the top cover of the external shielding box as shown in Figure 10-9.
10-12
Maintaining Your Analyzer
6. Once the top cover of the external shielding box is removed, you will see a small RBC
shielding box inside. Dispense about 1.5mL of probe cleanser into the RBC bath, as
shown in Figure 10-10.
z If the probe cleanser accidentally spills on your skin or clothing, wash it off
with plenty of water immediately.
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
10-13
Maintaining Your Analyzer
7. After the dispensation, reassemble the top cover as shown in Figure 10-11, relocate and
tighten the screw and then close the front cover.
8. The dialog box will close once the count-down is complete. If the dispensation is complete
before the end of the count-down, CLICK “OK” to close the dialog box. The analyzer will
start to maintain the RBC bath and a count-down dialog box shown in Figure 10-12 will
pop up.
9. It takes 5 minutes to maintain the bath. Once the count-down is complete, the dialog box
will close and the analyzer will start to clean the tubing with probe cleanser. Note that you
can choose to end the maintaining process before the time is due by clicking “OK”.
However, a shortened process may not be as effective as a complete one.
10. When “Maintenance finished” appears in the dialog box, CLICK “OK” to close the dialog
box. The RBC bath maintaining with probe cleanser is done.
The HGB bath maintaining has the similar process to the RBC bath maintaining. Do as follows:
1. CLICK the “HGB bath” button at the “Maintenance” screen. A progress bar shown in
Figure 10-13 will pop up and the maintaining preparation of the HGB bath will start.
10-14
Maintaining Your Analyzer
2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-14 will pop up.
3. Remove the top cover as instructed in the steps 3 to 5 of the Maintaining the RBC Bath.
Dispense about 1.5mL of probe cleanser into the HGB bath as shown in Figure 10-15.
HGB bath
z If the probe cleanser accidentally spills on your skin or clothing, wash it off
10-15
Maintaining Your Analyzer
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
4. After the dispensation, reassemble the top cover as instructed in step 7 of the Maintaining
the RBC Bath, and close the front cover.
5. The dialog box will close once the count-down is complete. If the dispensation is complete
before the end of count-down, CLICK “OK” to close the dialog box. The analyzer will start
to maintain the HGB bath and a count-down dialog box shown in Figure 10-16 will pop up.
6. It takes 5 minutes to maintain the bath. After the count-down, the dialog box will close and
the analyzer will start to clean the tubing with probe cleanser. Note that you can choose to
end the maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.
7. When “Maintenance finished” appears in the dialog box, CLICK “OK” to close the dialog
box. The HGB bath maintaining with probe cleanser is done.
The premix bath maintaining has the similar process to the RBC bath maintaining. Do as
follows:
1. CLICK the “Premix bath” button at the “Maintenance” screen. The maintaining
preparation of premix bath will start and a progress bar shown in Figure 10-17 will pop up.
10-16
Maintaining Your Analyzer
2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-18 will pop up.
3. Open the front cover of the analyzer and dispense about 1.5mL of probe cleanser into the
premix bath as shown in Figure 10-19.
premix bath
z If the probe cleanser accidentally spills on your skin or clothing, wash it off
10-17
Maintaining Your Analyzer
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
6. It takes 5 minutes to maintain the bath. After the count-down, the dialog box will close and
the analyzer will start to clean the tubing with probe cleanser. Note that you can choose to
end the maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.
7. When “Maintenance finished!” appears in the dialog box, CLICK “OK” to close the dialog
box. The premix bath maintaining with probe cleanser is done.
Before maintaining, you should prepare a special syringe used for injecting the probe cleanser
into the DIFF bath and BASO bath manually.
10-18
Maintaining Your Analyzer
2. Insert the tip of the syringe into the 15mm Tygon tubing as shown in Figure 10-22.
3. Insert the 80mm Teflon tubing from the tip of the 15mmTygon tubing into the syringe, until
it touches the plug of the syringe (be sure the plug is at the “0” scale) as shown in Figure
10-23.
10-19
Maintaining Your Analyzer
After preparing the syringe, you can start maintaining the WBC module. Do as follows:
1. CLICK the “WBC module” button at the “Maintenance” screen. The maintaining
preparation of WBC module will start and a progress bar shown in Figure 10-25 will pop
up.
10-20
Maintaining Your Analyzer
2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-26 will pop up.
3. Open the front cover of the analyzer and take off the two rubber plugs from the WBC
module as shown in Figure 10-27.
z If the probe cleanser accidentally spills on your skin or clothing, wash it off
with plenty of water immediately.
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
4. Aspirate 1.6ml probe cleanser by the prepared special syringe, then insert the extended
tubing of syringe down to the channels, until it reaches the bottom of the DIFF bath and
10-21
Maintaining Your Analyzer
BASO bath, then Inject about 0.8mL of probe cleanser into the DIFF bath and BASO bath
respectively as shown in Figure 10-28.
Figure 10-28 Inject the probe cleanser into the DIFF bath and BASO bath
5. Once the injection is complete, put the the two rubber plugs back as shown in Figure 10-29
and close the front cover.
6. The dialog box will close once the count-down is complete. If the injection is complete
before the end of count-down, CLICK “OK” to close the dialog box. The analyzer will start
to prime probe cleanser and a progress bar shown in Figure 10-30 will pop up.
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Maintaining Your Analyzer
7. Once the priming is completed, the analyzer will start to maintain the WBC module and a
count-down dialog box shown in Figure 10-31 will pop up.
8. It takes 5 minutes to maintain the WBC module and you can not end the maintaining
process. After the count-down, the dialog box will close and the analyzer will start to clean
the tubing, and a progress bar shown in Figure 10-32 will pop up.
9. When the cleaning is finished, CLICK “OK”, and then “Maintenance finished!” appears in
the dialog box, and then CLICK “OK” to close the dialog box. The WBC module
maintaining with probe cleanser is done.
Before maintaining, you should prepare a special syringe used for injecting the probe cleanser
into the DIFF bath and BASO bath manually. Do as instructed in Maintaining the WBC Module.
After preparing the syringe, you can start maintaining the five baths. Do as follows:
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Maintaining Your Analyzer
1. CLICK the “Five baths” button at the “Maintenance” screen. The maintaining preparation
will start and a progress bar shown in Figure 10-33 will pop up.
2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-34 will pop up.
3. Open the front cover of the analyzer and inject about 0.8mL of probe cleanser into the
DIFF bath and BASO bath respectively as instructed in Maintaining the WBC Module.
Then, inject 1.5ml porbe cleanser into both the HGB bath and the RBC premix bath as
instructed in Maintaing the HGB Bath and Maintaing the Premix Bath. Finally, inject 1.5ml
probe cleanser into the RBC bath as instructed in Maintaing the RBC Bath.
z If the probe cleanser accidentally spills on your skin or clothing, wash it off
with plenty of water immediately.
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
4. Once the injection is complete, reassembly the corresponding parts and close the front
cover.
5. The dialog box will close once the count-down is complete. If the injection is complete
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Maintaining Your Analyzer
before the end of count-down, CLICK “OK” to close the dialog box. The analyzer will start
to prime probe cleanser and a progress bar shown in Figure 10-35 will pop up.
6. Once the priming is complete, the analyzer will start to maintain the five baths and a
count-down dialog box shown in Figure 10-36 will pop up.
7. It takes 5 minutes to maintain the five baths and you can not end the maintaining process.
After the count-down, the dialog box will close and the analyzer will start to clean the
tubing, and a progress bar shown in Figure 10-37 will pop up.
8. When the cleaning is finished, CLICK “OK”, and then “Maintenance finished!” appears in
the dialog box, and then CLICK “OK” to close the dialog box. The five baths maintaining
with probe cleanser is done.
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Maintaining Your Analyzer
SRV Maintenance
Do the following steps to maintain the SRV:
1. At the “Maintenance” screen, CLICK the “SRV” button to start the SRV maintenance
preparation process.
2. Aspirate probel cleanser into the analyzer as prompted by the message box.
3. When the aspiration is done, the analyzer will start to prime probe cleanser and a progress
bar will pop up. Once the priming is done, the maintenance process begins. The probe
cleanser maintenance will repeat for three times together with the following count-down
box of five minutes. Thus, the whole process lasts 15 minutes.
10-26
Maintaining Your Analyzer
5. When the cleaning process is done, the SRV maintenance ends. You can CLICK the “Ok”
button to exit.
Note that every time the analyzed samples add up to 2,000, the analyzer will automatically
start the SRV maintenance process. You wlill see the following message when the analyzed
samples add up to 1,950.
If you CLICK the “Ok” button, the maintenance starts right away, and if you CLICK the
“Cancel” button the message will be closed and pop up again after every 10 more samples.
When analyzed samples add up to 2,000, the analyzer automatically starts the maintenance
process.
z After every SRV maintenance, the “Total runs for auto SRV maintenance ”
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Maintaining Your Analyzer
Cleanser Maintenance
After the WBC bath cleaning, if the background of WBC relative parameters is still high, do as
follows:
1. CLICK the “WBC bath” and a progress bar of the maintaining preparation shown in Figure
10-44 will pop up.
2. Once the progress bar disappears, a count-down dialog box shown in Figure 10-45 will
pop up.
3. It takes 5 minutes to maintain the bath. After the count-down, the dialog box will close and
the analyzer will start to clean the tubing with probe cleanser. Note that you can choose to
end the maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.
4. When “Maintenance finished!” appears in the dialog box, CLICK “OK” to close the dialog
box. The WBC bath maintaining with probe cleanser is done.
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Maintaining Your Analyzer
Do as follows:
2. The fluidic system initialization will start and the “Initializing. Please wait…” and the
progress bar will be displayed at the screen.
3. Once the screen shows “Initialization finished!”, the fluidic system initialization is
complete. If the screen shows “Initialization error!”, contact Mindray customer service
department or your local distributor for assistance.
Priming
If the analyzer has not been used for a long time, you should perform this procedure to prime
the overall fluidic system after startup.
Do as follows:
1. CLICK the “Prime all” button at the “Overall” screen and a dialog box of “This action will
take a long time, continue?” shown in Figure 10-47 will pop up.
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Maintaining Your Analyzer
2. CLICK “No” to ignore the priming. CLICK “Yes” to proceed with the priming; the “Priming.
Please wait…” and the progress bar will be displayed at the screen.
3. Once the screen shows “Prime finished!”, the fluidic system priming is complete. If the
screen shows “Prime error!”, contact Mindray customer service department or your local
distributor for assistance.
Emptying
If the analyzer is not to be used in 2 weeks, you should perform this procedure to empty the
fluidic system.
Do as follows:
1. CLICK the “Drain” button at the “Overall” screen and a dialog box of “Start drain?”
shown in Figure 10-48 will pop up.
2. CLICK “Yes” to ignore the emptying. CLICK “No” to proceed with the emptying; a dialog
box shown in Figure 10-49 will pop up.
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Maintaining Your Analyzer
3. Remove all reagent pickup tube assemblies from their containers per the prompt of the
dialog box. CLICK “OK” to close the dialog box. The fluidic system emptying will start and
the “Draining. Please wait…” and the progress bar will be displayed at the screen.
4. Once the screen shows “Drain finished!”, the fluidic system emptying is complete. If the
screen shows “Drain error!”, contact Mindray customer service department or your local
distributor for assistance.
Cleaning
If the background of all parameters is high, you should perform this procedure to clean the
fluidic system.
Do as follows:
1. CLICK the “Clean all” button at the “Overall” screen and a dialog box of “This action will
take a long time, continue?” shown in Figure 10-50 will pop up.
2. CLICK “No” to ignore the cleaning. CLICK “Yes” to proceed with the cleaning. The
“Cleaning. Please wait…” and the progress bar will be displayed.
3. Once the screen shows “Clean finished!”, the fluidic system cleaning is complete. If the
screen shows “Clean error!”, contact Mindray customer service department or your local
distributor for assistance.
Cleanser Soaking
If the background of all parameters is still high after the overall fluidic system cleaning, you
should perform this procedure to soak and clean the fluidic system.
Do as follows:
1. CLICK the “Dip in cleanser” button at the “Overall” screen and a dialog box of “This
action will take a long time, continue?” shown in Figure 10-51 will pop up.
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Maintaining Your Analyzer
2. CLICK “No” to ignore the soaking. CLICK “Yes” to proceed with the soaking. The
“Prepare for dip.Please wait…” and the progress bar will be displayed.
3. After the preparation, a count-down dialog box shown below will pop up. The soaking will
take 20 minutes. After the count-down, the dialog box will close and the analyzer will start
to empty and then clean the tubing with cleanser. Note that you can choose to end the
maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.
4. Once the screen shows “Dip finished!”, the fluidic system soaking is complete. If the
screen shows “Dip error!”, contact Mindray customer service department or your local
distributor for assistance.
If the accumulated sample runs have reached or exceeded 350 but not reached 400 yet, a
dialog box as shown in Figure 10-53 will pop up.
If you want to perform the “Dip in cleanser” procedure immediately, CLICK “OK” (the dip
procedure lasts 20 minutes). If not, CLICK “Cancel”.
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Maintaining Your Analyzer
If the “Dip in cleanser” procedure is not performed, the dialog box will pop up again to prompt
user for the procedure every 10 runs. The analyzer will start the “Dip in cleanser” procedure
automatically when the accumulated runs reach or exceed 400 (the dip procedure lasts 20
minutes).
Packing up
If the analyzer is not to be used for over 2 weeks, you should perform this procedure and
shutdown the analyzer.
Do as follows:
1. CLICK the “Pack-up” button at the “Overall” screen and a dialog box shown in Figure
10-54 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 10-55 will pop up.
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 10-56 will pop up.
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Maintaining Your Analyzer
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 10-57 will pop up.
6. Remove all the pickup tube assemblies of diluent, cleanser and lyse 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, place the power switch to the OFF (O) to turn off your analyzer.
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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 10-58.
10-35
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
10-59.
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.
10-36
Maintaining Your Analyzer
CLICK the “Vol. & Cur” button at the “Status” screen to enter the screen shown in Figure
10-60.
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:
CLICK the “Position” button at the “Status” screen to enter the screen shown in Figure 10-61.
10-37
Maintaining Your Analyzer
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
10-62.
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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.
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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 10-63.
10-40
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.
10-41
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 10-65 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.
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Maintaining Your Analyzer
CLICK the “Valve” button at the “Self-test” screen to enter the screen shown in Figure 10-66.
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 value self-test?” 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.
1. CLICK the “Dobber” button at the “Self-test” screen to enter the screen shown in
Figure 10-67.
10-43
Maintaining Your Analyzer
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 10-68.
10-44
Maintaining Your Analyzer
2. CLICK the “Calibrate” button in the middle of the screen and the screen will be shown as
Figure 10-69.
10-45
Maintaining Your Analyzer
3. CLICK the blue point at the upper left corner of the screen as prompted to start the
calibration.
4. Then CLICK the blue point at the lower right corner of the screen and the screen will be
shown as Figure 10-70.
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.
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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 maximum 1000 log records. When the maximum number has been
reached, the newest result 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 10-71.
Browse
As a common user, you can only CLICK the “All”, “Set paras” or “Others” button to browse
the interested information.
As an administrator, besides the above information, you can also CLICK the “Error info.”
button to check the lately reported error messages.
10-47
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.
10-48
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 10-72.
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.
10-49
Maintaining Your Analyzer
To exit the “Init” screen, CLICK any other button at the bottom of the screen.
10-50
Maintaining Your Analyzer
“Unclog” button
CLICK the “Unclog” button at the bottom of the “Count” screen directly to prevent or remove
the RBC clogging.
“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.
10-51
Maintaining Your Analyzer
Do as follows:
z 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 10-73.
z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
10-52
Maintaining Your Analyzer
SRV tray
z 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.
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
z Reassemble the SRV tray by facing the side with the groove up.
10-53
Maintaining Your Analyzer
z 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.
z 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.
z 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.
z 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.
z 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.
z Wear gloves when cleaning the SRV. Wash your hands with disinfector after
the SRV cleaning.
Do as follows:
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Maintaining Your Analyzer
z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
3. Remove the SRV tray and pull the probe wipe assembly down to the lowest position as
shown in Figure 10-74.
z 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.
10-55
Maintaining Your Analyzer
6. Remove the sampling valve and the rotor valve of the SRV respectively as shown in Figure
10-76.
z When the SRV is disassembled, reagent may leak from the tubes. Place a
dry cloth or tissue under the SRV to absorb any reagent.
z 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 10-77.
10-56
Maintaining Your Analyzer
8. Use clean lint-free damp tissues to wipe the valve contact surfaces clean with probe
cleanser, as Figure 10-78 shows. Then wash the valves with distilled water.
z 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.
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Maintaining Your Analyzer
z The valve contact surfaces must be damp when the SRV is reassembled.
z Position the metal knob between the two stoppers when reassembling the
rotor valve. Otherwise, the SRV may not function.
z 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.
z 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.
z 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.
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
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Maintaining Your Analyzer
z 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.
Unit
You should clean the probe wipe if residual blood or dirt is found in the probe wipe of the open
– tube sampling unit.
z 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.
z 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.
z 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.
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Maintaining Your Analyzer
2. Pull the probe wipe assembly down to the lowest position and remove the probe wipe from
the probe.
3. Separate the probe wipe from the probe wipe assembly as shown in Figure 10-80.
Disconnect the tubes from the probe wipe.
Figure 10-80 Separating the probe wipe of the open vial sampling unit
z 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.
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.
z 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.
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Maintaining Your Analyzer
z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z To avoid damage to the components of the analyzer, close the front cover
gently.
z 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.
z All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
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 10-81.
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Maintaining Your Analyzer
Accumulation tray
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.
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Maintaining Your Analyzer
10.9 Adjustment
10-63
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 10-84.
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.
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Maintaining Your Analyzer
z 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. Use a wrench to loosen the lock nut of the 0.16MPa pressure regulator shown in Figure
10-86.
lock nut
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, tighten the lock nut of 0.16MPa pressure regulator.
Do as follows:
1. Use a wrench to loosen the lock nut of the0.07MPa pressure regulator shown in Figure
10-87.
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Maintaining Your Analyzer
lock nut
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, tighten the lock nut of 0.07MPa pressure regulator.
Do as follows:
1. Pull up the adjustment knob of the - 0.04MPa pressure regulator as shown in Figure
10-88.
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.
10-66
Maintaining Your Analyzer
z The piercer tip is sharp and may contain biohazardous materials. Exercise
caution to avoid direct contact with the probe when working around it.
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 10-89 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 10-90 shows.
10-67
Maintaining Your Analyzer
fixing nut
Probe wipe
3. Unscrew the two fixing screws secured the fixing block, as Figure 10-91 shows. Remove
the block and then the piercer in the direction shown in Figure 10-92.
piercer
fixing block
10-68
Maintaining Your Analyzer
4. Take a new piercer from the accessory kit, insert it through the probe wipe, and
reassemble the fixing block to fix the new piercer.
5. 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 10-93.
Pincher
Protective cover
2. Unscrew the fixing screws shown in Figure 10-94 to remove the protective cover for the
pincher. Unscrew the fixing screw shown in Figure 10-95 to remove the pincher.
10-69
Maintaining Your Analyzer
4. Reassemble the protective cover and close the front cover of the analyzer.
10-70
11 Troubleshooting Your Analyzer
11.1 Introduction
This chapter contains information that is helpful in locating and correcting problems that may
occur during operation of your analyzer.
11-1
Troubleshooting Your Analyzer
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, orange, yellow, green and blue. 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.
Sample compartment error 1. Check whether the sample compartment door is unexpectedly
open.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator pinch error 1. Remove the rack(s) from the autoloader or the tube from the
11-3
Troubleshooting Your Analyzer
sample compartment.
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 or the tube from the
sample compartment.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator mix error 1. Remove the rack(s) from the autoloader or the tube from the
sample compartment.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Wipe block action error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Tube fallen off or piercing 1. Remove the tube(s) or rack(s) from the autoloader or the tube
error from the sample compartment.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator is working 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Sheath syringe action error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Pump syringe action error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Heater: preheat bath temp. 1. Perform the shutdown procedure to shut down the analyzer
sensor error and then restart it.
2. If the error still exists, contact our customer service
department.
Heater: reaction bath temp. 1. Perform the shutdown procedure to shut down the analyzer
sensor error and then restart it.
2. If the error still exists, contact our customer service
department.
Laser diode temp. sensor 1. Perform the shutdown procedure to shut down the analyzer
error and then restart it.
2. If the error still exists, contact our customer service
department.
No Diluent 1. Check whether the diluent container is empty.
11-4
Troubleshooting Your Analyzer
11-5
Troubleshooting Your Analyzer
Waste cistern is full 1. Empty the waste container or install a new waste container.
2. If the error still exists, contact our customer service
department.
No Cleanser 1. Check whether the cleanser container is empty.
2. If there is no cleanser, install a new container of cleanser.
Then press the "Remove error" button to prime the analyzer with
the cleanser.
3. See Heading 5.2.1 Settings to modify the reagent expiration
date.
4. If there is still plenty of cleanser, or if the error still exists after
a new container of cleanser is installed, contact our customer
service department.
Front cover open 1. Close the front cover.
2. If the error still exists, contact our customer service
department.
Laser box open 1. Close the laser box.
2. If the error still exists, contact our customer service
department.
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].
11-6
Troubleshooting Your Analyzer
11-7
Troubleshooting Your Analyzer
11-8
Troubleshooting Your Analyzer
LEO(II) expired 1. Check whether the LEO(II) lyse is out of the expiration date. If
yes, install a new container of LEO(II) lyse.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the LEO(II) lyse is set correctly.
LBA expired 1. Check whether the LBA lyse is out of the expiration date. If
yes, install a new container of LBA lyse.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the LBA lyse is set correctly.
LH expired 1. Check whether the LH lyse is out of the expiration date. If yes,
install a new container of LH lyse.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the LH lyse is set correctly.
Cleanser expired 1. Check whether the cleanser is out of the expiration date. If
yes, install a new container of cleanser.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the cleanser is set correctly.
Network connection 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.
Network communication 1. Reconnect to the data management software or the LIS
error system.
2. If the connection succeeds, the error will be removed
automatically.
3. If the error still exists, contact our customer service
department.
Auto communication 1. See Heading 5.2.1 Settings and check whether the auto
operation error communication is on
2. If the auto communication is on, check whether the data
management software or the LIS system is connected to the
analyzer successfully.
3. If the error still exists, contact our customer service
department.
IP address collision 1. Check whether there are repeated IDs within the LAN.
2. If no repeated IDs, this error will be removed automatically.
3. If the error still exists, contact our customer service
department.
Printer out of paper 1. Put in print paper.
2. If the error still exists, contact our customer service
department.
ps data generation error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Auto-print records full. 1. Print records full. Please wait. This error will be removed
11-9
Troubleshooting Your Analyzer
11-10
12 Appendices
A Index
A C
adapter, 6-41, 6-62 calibration
Adjustment, 10-56 auto calibration, 9-6
AL auto calibration, 9-5
unloading tray is full, 11-3 conditions, 9-2
analyzer manual calibration, 9-15
intended use, 2-2 calibrator, 2-21
name, 2-1 Carryover, B-4
Aspiration, 3-2 Cistern operation error, 11-3
auto calibration Cleaning, 10-6
commercial calibrators, 9-6 Cleaning Manually, 10-45
fresh blood samples, 9-11 Cleanser expired, 11-9
Auto communication operation error, 11-9 Close Tube Sampler, 2-12
Autoloader, 2-12 control, 2-21
Autoloader is working, 11-3 CV
Auto-print records full. Cannot add new job definition, 7-15
now., 11-9 formula, 7-15
B D
Background abnormal, 11-8 Data collection sub-system com. error,
barcode, B-7 11-7
barcode label, 6-61 DIFF stirring motor abnormal, 11-6
Bas# Diluent
definition, 3-9 definition, 2-20
formula, 3-9 Diluent expired, 11-8
Bas% Dilution, 3-3
definition, 3-9
formula, 3-9
E
BASO stirring motor abnormal, 11-6
blank photocurrent, 3-11 Electrical Impedance method, 3-12
Eos#
definition, 3-10
A-1
Appendices
F M
flag, 6-53 M-50 Cleanser
Flow Cytometry by Laser, 3-7 definition, 2-21
Front cover open, 11-6 M-50LBA Lyse
definition, 2-21
M-50LEO(I) Lyse
H
definition, 2-20
HCT M-50LEO(II) Lyse
formula, 3-14 definition, 2-20
Heater M-50LH Lyse
preheat bath temp. sensor error, 11-4 definition, 2-21
reaction bath temp. sensor error, 11-4 M-50P Probe Cleanser
HGB definition, 2-21
formula, 3-11 Main board chip error, 11-7
measurement, 3-11 Maintenance, 10-8
HGB adjust, 11-8 maintenance program, 10-2
HGB error, 11-8 Manipulator is working, 11-4
Manipulator elevation error, 11-4
Manipulator mix error, 11-4
I Manipulator pinch error, 11-3
A-2
Appendices
A-3
Appendices
A-4
B Specifications
B.1 Classification
According to the CE classification, the BC-5500 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.
B.3 Controls
Specified by manufacturer.
B.4 Reagents
M-50 Diluent M-50D DILUENT
M-50LEO (I) LYSE
M-50 Lyse M-50LEO (II) LYSE
M-50LH LYSE
M-50LBA LYSE
M-50 CLEANSER
M-50 Cleanser M-50P PROBE CLEANSER
B-1
Appendices
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 %
Mean Corpuscular Volume MCV fL
Mean Corpuscular Hemoglobin MCH pg
Mean Corpuscular Hemoglobin MCHC g/L
Concentration
Red Blood Cell Distribution Width RDW-SD fL
Standard Deviation
Red Blood Cell Distribution Width RDW-CV %
Coefficient of Variation
Platelet count PLT 109 / L
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW None
Plateletcrit PCT %
Red Blood Cell Histogram RBC Histogram None
Platelet Histogram PLT Histogram None
Basophils Scattergram BAS Scattergram None
4 differential Scattergram Diff Scattergram None
B-2
Appendices
B.7.3 Throughput
Autoloading 80 analyses / 1 hour
Open vial sampling (whole blood) 60 seconds / analysis
Open vial sampling (prediluted) 70 seconds / analysis
B-3
Appendices
B.8.4 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 Predilute
Reproducibility(CV% / Reproducibility (CV%)
absolute deviation d※)
WBC (6.0~15.0)×109/L ≤ 2.5% ≤ 9.0%
B.8.5 Carryover
Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 1.0 %
PLT ≤ 1.0 %
B-4
Appendices
B.9.5 Printer(optional)
The analyzer supports such printers:
Black-and-white laser printer: HP LaserJet1320, HP LaserJet2420d, HP LaserJet 1022(B&W),
LaserJet 1010(fast).
Color inkjet printer: HP DeskJet 1280, HP Office Pro K5300.
Dot-matrix printer: Epson LQ-630K.
B.10 Interfaces
One LAN interface, built-in 100M network card, TCP/IP compatible
4 USB interfaces
B-5
Appendices
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 %
Height
Depth
Width
B-6
Appendices
B-7
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 Warnings
z 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.
z Before turning on the analyzer, make sure the input voltage meets the
requirements.
z 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.
z 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.
z The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.
z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.
z The SRV tray may contain biohazardous materials. Exercise caution to avoid
direct contact with the tray.
z When removing the SRV tray, do not loosen the thumbscrew fixing the
C-2
Appendices
sample probe; otherwise air may enter the sample probe and unreliable
results may be obtained.
z 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-3
Appendices
C.3 Cautions
z 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.
z 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
closed-tube sampling mode and autoloading mode.
z 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 closed-tube sampling
mode and autoloading mode.
z 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.
z Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
z To avoid damage to the components of the analyzer, close the front cover
gently.
z 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.
C-4
Appendices
z 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.
z 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.
z When the SRV is disassembled, reagent may leak from the tubes. Place a
dry cloth or tissue under the SRV to absorb any reagent.
z 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.
z 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.
z 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.
z Once reagents spill on the surface of the analyzer, wipe them off with a
damp cloth or tissue as soon as possible.
z 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.
z 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.
z Position the metal knob between the two stoppers when reassembling the
rotor valve. Otherwise, the SRV may not function.
C-5
Appendices
C.4 Notes
z 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.
z Do not adjust the pneumatic relief valve. Contact Mindray customer service
department or your local distributor if necessary.
z Store and use the reagents as instructed by instructions for use of the
reagents.
z When you have changed the diluent, cleansers or lyses, run a background
to see if the results meet the requirement.
z Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.
z After installing a new container of reagent, keep it still for a while before use.
z Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.
z 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.
z If the impact printer is connected when the analyzer is on, you need to
restart the analyzer to use the printer.
z Be sure to check the printout if the print format is changed or a new printing
title is entered.
z To avoid personal injury and analyzer damage, setting the autoloader stop
conditions is recommended.
z Be sure that the symbology and the character length set match the actual
bar-code.
C-6
Appendices
z You can delete the only one piece of the code information each time.
z You can delete only one piece of user information each time.
z Since the pneumatic unit is controlled by the analyzer, the power switch of
the pneumatic unit can be kept in the ON position (I).
z 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.
z If user switching is necessary, CLICK the “Logout” icon at the “Main” screen.
Enter the desired user name and the password into the popup dialog box
and CLICK the “OK” button to log in.
z Running sample with the background abnormal error present will lead to
unreliable results.
z For the whole blood samples to be used for WBC differential or PLT count,
you shall store them at the room temperature and run them within 8 hours
after collection.
z If you do not need the PLT, MCV and WBC differential results, you can store
the samples in a refrigerator (2℃ - 8℃) for 24 hours. You need to warm the
refrigerated samples at room temperature for at least 30 minutes before
running them.
z Be sure to mix any sample that has been prepared for a while before running
it.
z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.
z WBC differential results obtained in the predilute mode are for reference
only.
z You can also aspirate 120µL of diluent by pipette into the tube.
C-7
Appendices
z After mixing the capillary sample with the diluent, be sure to wait 3 minutes
before running the sample.
z Be sure to run the prediluted samples within 30 minutes after the mixing.
z Repeat steps 7 and 8 and you can prepare more prediluted samples.
z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.
z If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.
z You can edit the “Tester” box at the review screen only after the analysis is
finished.
z The previous operating mode and sample ID are default values in the “Work
list”. Modify them as instructed if necessary.
z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be imprecise.
z When the aspiration is done, remove the control vial/sample tube only when
the sample probe is out of the tube.
z 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”.
z During the analysis, CLICK the “Work list” button to enter the information for
the next sample.
z 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.
z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.
z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See
C-8
Appendices
z When the PLT value is less than 100 × 109 / L, a manual count by the
microscope is recommended.
z The first default rack number is the number of the first detected sample
carrier after the analysis is started.
z You can reedit or delete the information of the sample erroneously analyzed.
z 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.
z Do not enter repeated sample ID, rack No. and tube No simultaneously.
z After the sample information is changed, the status of “Error” will become
“Ready”. You can rerun the corresponding sample.
z The measuring modes of the same batch samples are the same.
z If “Invalid” appears on the sample ID box, it means the scan is invalid. You
can enter the sample ID again when reviewing sample results. See Chapter 7
Reviewing Sample Results for details.
z If the samples to be run of the same batch need more than 5 racks, 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.
z When the detected tube No. of the first sample is not the same with that
saved in the “Work mode” dialog box, the detected tube No. of the first
sample, and the sample ID, rack No. and measuring mode saved in the
“Work mode” dialog box will be written into the work list as the information
of the sample.
z 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.
z When the detected tube No. or sample ID of the first sample is not the same
with that saved in the “Work mode” dialog box, the detected tube No. and
sample ID of the first sample, and the rack No. and measuring mode saved
in the “Work mode” dialog box will be written into the work list as the
information of the sample.
z Blood, scratches and powder from gloves reduces bar-code read rate. Keep
the bar-code label free of blood, scratches and powder from gloves to
C-9
Appendices
z The bars on the label must be parallel to the stopper. Otherwise, the scanner
may not read it.
z 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.
z 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 deselect
all sample results.
z 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.
z You can select up to 500 samples at a time. If the results found are more
than 500, the first 500 results found will be taken.
z Once you leave the “Table Review” screen, the sample results saved in the
search database will be cleared.
z 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.
z CLICK the “RUO” button to browse the analysis results of RUO parameters.
z 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
C-10
Appendices
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.
z 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.
z 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.
z 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.
z The settings can be saved only when both the expected result and limit are
valid.
z Be sure to use the Mindray- specified controls. Using controls other than
the specified will lead to misleading results.
z Refer to the instructions for use of the controls for how to store and use
them.
z After mixing the control with the diluent, be sure to wait 3 minutes before
running the control.
z Be sure to run the prediluted control within 30 minutes after the mixing.
z Be sure to mix any control that has been prepared for a while before running
it.
z When the built-in barcode scanner is not used, you can run only one control
each time.
z The QC file No. of the same batch of controls must be the same.
z If the saved within control results of L-J QC graph are less than 3, the
“Mean”, “SD” and “CV%” of every parameter are all empty.
z After every deletion, the following results will sequentially move forward
and their No. will be refreshed.
z The expected results vary with areas. It is recommended they are obtained
C-11
Appendices
z 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.
z 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.
z CLICK the “Close” radio button of “X-B QC” to deactivate the X-B analysis.
The default setting is “OFF”.
z Refer to the instructions for use of the calibration materials and reagents for
how to store and use them.
z Refer to the instructions for use of the controls and reagents for how to
store and use them.
z 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.
z Refer to the instructions for use of the calibrator for information on the lot
number, expiration date, open vial stability days and reference values.
z 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 +
C-12
Appendices
z You can delete only one group of data by clicking the “Delete” button once
on the screen.
z You cannot delete the calculated CVs and calibration factors at the “Blood”
count screen.
z Reassemble the SRV tray by facing the side with the groove up.
z Make sure no dust should be found in the holes and grooves and on the
surfaces after the cleaning.
z The valve contact surfaces must be damp when the SRV is reassembled.
z Be sure the sampling valve, rotor valve and rear fixed valve of the SRV
attach well after the reassembly.
z If the pressure is adjusted too high, you should adjust it to the lowest level
before readjusting it to the desired level.
z If abnormal power failure occurs after the analysis starts, open the front
cover to check for fallen test tube and take it out, if any.
z 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.
z 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.
z To change the time when to start the liquid saver, see Heading 5.3.1 Settings
for details.
z At the screens of “Mechanical”, “Circuit” and “Valve”, the analyzer will not
enter the liquid saver status.
C-13
Appendices
z If it is time for liquid saver, some current operations will pause. When the
analyzer is in the liquid saver status, you can continue the operations.
C.5 Biohazard
z All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.
C-14
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 whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 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
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
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# > 1.0×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L
C-15
Appendices
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
analyzer may be abnormal.
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.
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 two more peaks in the
distribution RBC histogram.
C-16
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-17
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-18
D Communication
D.1 Introduction
The BC-5500 can transmit the sample data and QC data to an external computer (a host)
through its network port. 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 Programming
D.2.1 Description
Data transmission communication port: 5500
Measurement mode inquiry communication port: 5501
Client terminal
1. The client terminal (the external computer) requests a network connection to establish a
TCP communication channel with the server terminal (the analyzer).
2. The blocking mode of client terminal receives data and sets the maximum waiting time of
receiving to be 5 seconds.
The client terminal starts to receive sample data once it receives the MS (0x05). When
receives the ME (0x0A), the client terminal will parse the data between MS and ME to
obtain a piece of sample data, and then go back to step 2.
If the client terminal receives data not begin with MS(0x05), it is invalid data and will be
abandoned directly.
Server terminal
1. The server terminal establishes the communication thread and monitors the network
connection requested outside.
2. The server terminal receives the network connection, establishes the TCP communication
channel with the client terminal (the external computer) and creates a special data
communication thread for communication.
3. The user sends the sample data package manually. After the sending, it will go back to
step 3.
4. The network connection will be closed data transmission thread will be destroyed.
D-2
Appendices
1. The client terminal requests the 5501 port of the analyzer to establish a network
connection.
2. The client terminal waits for receiving measurement mode inquiry request.
The client terminal obtains the requested sample ID from the measurement inquiry, and
returns the corresponding measurement mode to the analyzer through measurement
mode inquiry response, and then goes back to step 2.
1. The 5501 port of the server terminal monitors the TCP communication requested by LIS
system.
2. The server terminal receives the communication request from LIS system, establishes the
TCP measurement mode inquiry communication channel with the client terminal (LIS
system).
3. For bi-directional LIS mode, the server terminal requests the LIS system for measurement
mode inquiry first.
4. If the server terminal receives the measurement mode inquiry response within 2 seconds,
then the inquiry succeeded. Otherwise, the measurement mode inquiry failed, and then go
back to step 3.
D-3
Appendices
Protocol data package is the smallest unit of the transmission. Every transmission shall meet
the requirements of constructing a complete protocol data package, regardless the quantities
of the data.
Message: a complete data package is called the 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
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.
D-4
Appendices
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.
D-5
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-6
Appendices
FE field
FD field
D-7
Appendices
D-8
Appendices
D-9
Appendices
D-10
Appendices
D-11
Appendices
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 White Blood
WBC
Val Low High Unit Flag Mean Range 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
Basophils
Bas# The same with those of WBC
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
The same with those of WBC
Cell 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
D-12
Appendices
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# Abnormal
The same with those of WBC 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
Immature
The same with those of WBC
Cells
percentage
Low angle
WBC(Diff)
LasDiff The same with those of WBC
value of gain
calibration
D-13
Appendices
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
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
D-14
Appendices
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
WbcSepFlag 1 for
Val
differential; 0
for
non-differential
FD1 FD2 Discriminators
SepRBCLeft SepRBCRight of histogram
SepLine
FD3 FD4
SepPLTLeft SepPLTRight
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
Prompt of
FD16 FD17 FD18 FD19 FD20
AbnormalFlag abnormal
WMonHigh WEosHigh WBasHigh WBCHigh WBCLow
sample result
FD21 FD22 FD23 FD24 FD25
RDistri RAniso RMicro RMacro REryth
FD26 FD27 FD28 FD29 FD30
D-15
Appendices
D-16
Appendices
This section demonstrates the communication protocol through the description of sample data
and coding data.
For example, the MS field (0x05) will be displayed as “{” in the demonstration data in the
D-17
Appendices
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, data types and analysis parameters of coding data.
{CTR#WBC:Val,9.52;Low,4.00;High,10.00;Flag,0;Unit,10^9/L;$Neu#:Val,6.
20;Low,2.00;High,7.00;Flag,0;Unit,10^9/L;$Lymph#:Val,2.37;Low,0.80;Hi
gh,4.00;Flag,0;Unit,10^9/L;$Mon#:Val,0.71;Low,0.12;High,0.80;Flag,0;U
nit,10^9/L;$Eos#:Val,0.21;Low,0.02;High,0.50;Flag,0;Unit,10^9/L;$Bas#
:Val,0.03;Low,0.00;High,0.10;Flag,0;Unit,10^9/L;$Neu%:Val,65.1;Low,50
.0;High,70.0;Flag,0;Unit,%;$Lymph%:Val,24.9;Low,20.0;High,40.0;Flag,0
;Unit,%;$Mon%:Val,7.5;Low,3.0;High,8.0;Flag,0;Unit,%;$Eos%:Val,2.2;Lo
w,0.5;High,5.0;Flag,0;Unit,%;$Bas%:Val,0.3;Low,0.0;High,1.0;Flag,0;Un
it,%;$RBC:Val,482;Low,350;High,550;Flag,0;Unit,10^4/uL;$HGB:Val,134;L
ow,110;High,160;Flag,0;Unit,g/L;$HCT:Val,0.393;Low,0.370;High,0.500;F
lag,0;Unit,L/L;$MCV:Val,81.6;Low,80.0;High,100.0;Flag,0;Unit,fL;$MCH:
Val,27.8;Low,27.0;High,31.0;Flag,0;Unit,pg;$MCHC:Val,341;Low,320;High
,360;Flag,0;Unit,g/L;$RDW-CV:Val,15.1;Low,11.5;High,14.5;Flag,0;Unit,
%;$RDW-SD:Val,45.5;Low,35.0;High,56.0;Flag,0;Unit,fL;$PLT:Val,320;Low
,100;High,300;Flag,0;Unit,10^9/L;$MPV:Val,6.4;Low,7.0;High,11.0;Flag,
0;Unit,fL;$PDW:Val,15.5;Low,15.0;High,17.0;Flag,0;Unit,;$PCT:Val,0.20
5;Low,0.108;High,0.282;Flag,0;Unit,%;$ALY#:Val,0.08;Low,0.00;High,0.2
0;Flag,0;Unit,10^9/L;$ALY%:Val,0.8;Low,0.0;High,2.0;Flag,0;Unit,%;$LI
C#:Val,0.06;Low,0.00;High,0.20;Flag,0;Unit,10^9/L;$LIC%:Val,0.6;Low,0
.0;High,2.5;Flag,0;Unit,%;$LasDiff:Val,***.*;Low,***.*;High,***.*;Fla
g,0;Unit,fL;$MasDiff:Val,***.*;Low,***.*;High,***.*;Flag,0;Unit,fL;$L
asBaso:Val,***.*;Low,***.*;High,***.*;Flag,0;Unit,fL;$MasBaso:Val,***
.*;Low,***.*;High,***.*;Flag,0;Unit,fL;$GranX:Val,0;Low,*;High,*;Flag
,0;Unit,;$GranY:Val,0;Low,*;High,*;Flag,0;Unit,;$GranYW:Val,0;Low,*;H
igh,*;Flag,0;Unit,;$WBCBAX:Val,0;Low,*;High,*;Flag,0;Unit,;$WBCBAY:Va
l,0;Low,*;High,*;Flag,0;Unit,;$
Sample information
This section includes the following information: histogram discriminator information, particle
total information, mode, protocol version No., reference value group, WBC differential sign,
histogram adjustment sign, prompt of abnormal sample result, etc..
D-18
Appendices
SepLine:SepRBCLeft,30;SepRBCRight,166;SepPLTLeft,5;SepPLTRight,87;$To
tal:BasoTotal,952;DiffTotal,0;RbcTotal,485;PltTotal,329;$Mode:BloodMo
de,1;AnaMode,0;$ProtocolVer:Val,A;$SampGroup:Val,0;$WbcSepFlag:Val,0;
$HistoAdj:Val,0;$AlarmFlag:Val,0;$AbnormalFlag:WLeft,0;WRight,0;WGran
,0;WNrbc,0;WBlast,0;WAtl,0;WNeuLow,0;WNeuHigh,0;WLymLow,0;WLymHigh,0;
WMonHigh,0;WEosHigh,0;WBasHigh,0;WBCHigh,0;WBCLow,0;RDistri,0;RAniso,
0;RMicro,0;RMacro,0;REryth,0;RAgg,0;RUnnormal,0;RAnemia,0;RHypo,0;RTu
rbi,0;RDimor,0;RIron,0;PPenia,0;PSis,0;PDistri,0;PAgg,0;PMicro,0;$
Patient information
This section includes the following information: sample ID., name, gender, age, age type, bed
No., department, sender, tester, sending time, testing time, etc..
PatInfo:SampleID,1221kf9208;Gender,0;AgeType,1;Tester,Yang;$PatTime:T
estTime,2006-12-21 15:25:25;$
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. Take
the PLT histogram for example,
PLTHisto:DataLen,128;MetaDataLen,1;PHistoData,
".>Pdw 嫛 磁 愚 骒 蝓 鼯 ? 黩 脬 傥 梅 洃 噣
{wrmiffca^\[YXUTROKHD?<977789;;=<::86430.,*((&&&'''('))))*+**('&$"! -
;$
PLTHisto defines that the sequential contents are the PLT histogram information; DataLen,128
defines that the length of binary system data after PHistoData is 128 bytes; DataLen,128 and
MetaDataLen,1 define that the PLT histogram is (128/1=128) 128 channel data; Content after
PHistoData is the binary system data of PLT histogram.
D-19
Appendices
0x05 CMD 0x03 CTMR 0x0C SampleID 0x16 0x08 0x04 0x0A
FD separator V FE FD separator V FE SE ME
SampleID 0x16 0x08 AnaMode 0x16 0x08 0x04 0x0A
D-20
P/N: 3100-20-49382(1.6)