For this Operator’s Manual, the issued date is 2009-06.
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other
derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
, are the trademarks, registered or otherwise, of Mindray in China and
other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and
local requirements; and
the product is used in accordance with the instructions for use.
I
zIt is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or personal injury.
z Be sure to operate the analyzer under the situation specified in this manual;
otherwise , the analyze r will not w ork normall y and the ana lysis resul ts will
be unreliable, which would damage the analyzer components and cause
personal injury.
zThis equipment must be operated by skilled/trained clinical professionals.
II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Definitions
Main unit: Integrated facilities which implement the specified function separately.
Generally speaking, the main unit should include power supply, control system and
some functional modules.
Accessories: Materials connected to the main unit to extend or implement specified
function.
Consumables: Disposable or short-life parts which should be replaced each time after
use or periodically
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
The standard warranty period is as below:
Main unit: 18 months from shipment
Accessories: 15 months from shipment
Consumables: N/A
III
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:
1. Return authorization: Contact the international Customer Service Department and obtain
a Return Materials 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.
2. Freight policy: The customer is responsible for freight charges when this product is
shipped to Mindray for service (this includes customs charges).
3. Return address: Please send the part(s) or equipment to the address offered by the
A Index.........................................................................................................A-1
B Specifications ..........................................................................................B-1
4
Table of Contents
C Precautions, Limitations and Hazards...................................................C-1
D Communication (8ID communication protocol)....................................D-1
E Communication (15ID communication protocol)..................................E-1
5
1 Using This Manual
1.1 Introduction
This chapter explains how to use your operator’s manual, which is shipped with your
BC-2800 auto hematology analyzer and contains reference information about the BC-2800
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.
z Operate your analyzer strictly as instructed in this manual.
z All illustrations in this manual are provided as examples only. They may not
necessarily reflect your analyzer setup or data displayed and must not be
used for any other purpose.
1-1
Using This Manual
1.2 Who Should Read This Manual
This manual contains information written for clinical laboratory professionals to
learn about the BC-2800 hardware and software;
customize system settings;
perform daily operating tasks;
perform system maintenance and troubleshooting.
1-2
Using This Manual
1.3 How to Find Information
This operator’s manual comprises 11 chapters and 4 appendices. Refer to the table below to
find the information you need.
If you want to … See …
learn about the intended use and parameters of the BC-2800
learn about the hardware and software of the BC-2800
learn about how the BC-2800 works
learn about how to install the BC-2800
learn about how to define/adjust system settings
learn about how to use the BC-2800 to perform your daily
operating tasks
learn about how to review the saved analysis results
learn about how to use the quality control programs
Chapter 2 Understanding
Y our Analyzer
Chapter 2 Understanding
Y our Analyzer
Chapter 3 Understanding the
System Principles
Chapter 4 Installing Your
Analyzer
Chapter 5 Customizing the
Analyzer Software
Chapter 6 Operating Your
Analyzer
Chapter 7 Reviewing Sample
Results
Chapter 8 Using the QC
learn about how to calibrate the BC-2800
learn about how to maintain/service the BC-2800
learn about the meanings of the error messages and how to
correct the problems
learn about the technical specifications of the BC-2800
see the summary of all safety messages included in this
manual
learn about the communication protocol of the BC-2800
1-3
Programs
Chapter 9 Using the
Calibration Programs
Chapter 10 Maintaining Your
Analyzer
Chapter 11 Troubleshooting
Y our Analyzer
Appendix B Specifications
Appendix C Precautions,
Limitations and Hazards
Appendix D Communication
Using This Manual
1.4 Conventions Used in 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 built-in keypad or the
external keyboard), such as [ENTER].
All capital, bold and italic letters indicate a special operation defined in the following
section, such as SELECT.
Bold letters included in “ ” indicate text you can find on the screen, such as “Prepare to
ship”.
Bold letters indicate defined screen areas/fields, such as System Status area, or
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
1.5 Special Terms Used in This Manual
When you read … It means …
CLICK
ENTER
DELETE
to press the arrow keys ([←][→] [↑][↓]) as needed to move the
cursor to a certain software button on screen and press
[ENTER].
to press the arrow keys ([←][→] [↑][↓]) as needed to move
cursor to the desired edit box and use the built-in keypad or
the external keyboard to enter the desired characters or digits.
Note that besides the numeric keys you may also use the
[PgUp] or [PgDn] keys to enter digits; or to scan the number
using the bar-code scanner.
to press the arrow keys ([←][→] [↑][↓]) as needed to move the
cursor to the character or digit to the left of the one you want to
delete and press [DEL]; or to press the arrow keys
([←][→][↑][↓]) as needed to move the cursor to the character
or digit to the right of the one you want to delete and press
[BackSpace] on the external keyboard.
to move the cursor to the character or digit you want to change
MODIFY
SELECT from “ ** ”
pull-down list
SELECT
and re-enter the desired one using either the built-in keypad or
the external keyboard.
to press the arrow keys ([←][→] [↑][↓]) as needed to move the
cursor to the desired edit box and press [ENTER] to display
the pull-down list and press [↑] or [↓] to move the cursor to the
desired item and press [ENTER] to select it.
to press the arrow keys ([←][→] [↑][↓]) as needed to the
desired item and press [ENTER].
zThis analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.
1-5
Using This Manual
1.6 Symbols
You will find the following symbols in this manual.
When you see… Then…
read the statement below the symbol. The statement is
You may find the following symbols on the analyzer or the reagents.
When you see… It means…
alerting you to an operating hazard that can cause
personnel injury.
read the statement below the symbol. The statement is
alerting you to a possibility of analyzer damage or unreliable
analysis results.
read the statement below the symbol. The statement is
alerting you to information that requires your attention.
read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.
EQUIPOTENTIALITY
CAUTION, CONSULT ACCOMPANYING
DOCUMENTS.
BIOLOGICAL RISK
HIGH VOLTAGE
ALTERNATING CURRENT
USE BY
1-6
Using This Manual
SERIAL NUMBER
IN VITRO DIAGNOSTIC
DATE OF MANUFACTURE
TEMPERATURE LIMITATION
CONSULT INSTRUCTIONS FOR USE
THE DEVICE IS FULLY CONFORMANCE
WITH THE COUNCIL DIRECTIVE
CONCERNING IN VITRO DIAGNOSTIC
MEDICAL DEVICES 98/79/EC.
MANUFACTURER
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
IRRITATING SUBSTANCE
THE FOLLOWING DEFINITION OF THE
WEEE LABEL APPLIES TO EU MEMBER
STATES ONLY: THE USE OF THIS SYMBOL
INDICATES THAT THIS PRODUCT SHOULD
NOT BE TREATED AS HOUSEHOLD
WASTE. BY ENSURING THAT THIS
PRODUCT IS DISPOSED OF CORRECTLY,
YOU WILL HELP PREVENT BRINGING
POTENTIAL NEGATIVE CONSEQUENCES
TO THE ENVIRONMENT AND HUMAN
HEALTH. FOR MORE DETAILED
INFORMATION WITH REGARD TO
1-7
Using This Manual
RETURNING AND RECYCLING THIS
PRODUCT, PLEASE CONSULT THE
DISTRIBUTOR FROM WHOM YOU
PURCHASED THE PRODUCT.
1-8
Using This Manual
(4)
(3)
(2)
(1)
Figure 1-1 Back of the analyzer
(1)
Equipotentiality.
(2)
Connect only to a properly earth grounded outlet;
To avoid electric shock, disconnect power cord prior to removing or replacing fuse;
Replace fuse only with the type and rating specified.
(3)
Biological risk.
(4)
The following definition of the WEEE label applies to EU member states only: The use of this
symbol indicates that this product should not be treated as household waste. By ensuring that
1-9
Using This Manual
this product is disposed of correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For more detailed information with
regard to returning and recycling this product, please consult the distributor from whom you
purchased the product.
(5)
Figure 1-2 Warning label
(5)
To avoid being injured, do not put hand under the motor when the machine is running.
1-10
Using This Manual
(6)
Figure 1-3 Warning label
(6)
To avoid electrical shock, disconnect the power supply before maintaining this device.
1-11
Using This Manual
(7)
(7)
High Voltage
Figure 1-4 High voltage warning label
1-12
2 Understanding Your Analyzer
2.1 Introduction
The BC-2800 Auto Hematology Analyzer is a quantitative, automated hematology analyzer
and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories.
2-1
Understanding Your Analyzer
2.2 Intended Use
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 a maximum of 19 parameters and 3
3 --- RS-232 port2 4 --- Power Interface of Floppy Disk Drive
5 --- Keyboard interface
2-5
Understanding Your Analyzer
2.3.1 LCD
The LCD is located on the front panel of the analyzer, as Figure 2-4 shows. It displays all
alphanumeric and graphic data.
2.3.2 Input Devices
The input devices include the aspirate key, built-in keypad and PS/2 keyboard.
Aspirate key
The aspirate key is located behind the sample probe, as Figure 2-4 shows. You can press the
key to start the selected run cycle or dispense diluent.
Figure 2-4 Sample probe and aspirate key
1.Sample probe 2. Aspirate key
2-6
Understanding Your Analyzer
Built-in keypad
The 18-key keypad is located below the LCD, as Figure 2-5 shows.
Figure 2-5 Build-in keypad
PS/2 keyboard
The analyzer can also be controlled by an external PS/2 keyboard that should be connected
to the analyzer’s keyboard interface. See Table 2-1 for the correspondence between the
keypad keys and the keyboard keys and for their functions.
Table 2-1 Key functions
Keypad PS/2 keyboard Function
[MENU] [Esc] Press it to enter/exit the system menu.
[PRINT] [P] or [p] Press it to print out data by the recorder or printer.
[HELP] [H] or [h] Press it to call out the analyzer’s on-line help.
[DEL] [Delete] or [Del] Press it to delete data and characters.
[ENTER] [Enter] Press it to confirm or execute an operation
[↑], [↓],
[←], [→]
[F1], [F2], [F3],
[F4], [F5]
[PgUp][PgDn] [PageUp]
[↑], [↓],
[←], [→]
[F1], [F2], [F3],
[F4], [F5]
Press them to move the cursor.
Press them to use various functions. See the rest of this
manual or the analyzer’s on-line help for details.
Press them to scroll the screen.
[PageDown]
[MODE] [Ctrl+A] Switch to another analysis mode (works only in the
Count screen).
[DILUENT] In the prediluted mode, press it if you want to dispense
diluent into the sample tube.
/ Other keys Use them as needed. See the rest of this manual or the
analyzer’s on-line help for details.
2-7
Understanding Your Analyzer
2.3.3 Recorder
A thermal recorder is located on the front panel. It prints out analysis reports and other related
information.
2.3.4 Keyboard Interface
A PS/2 keyboard can be connected here.
2.3.5 Serial Ports
The analyzer provides two RS-232 ports, one for connecting the scanner and the other for
connecting a computer (host).
2.3.6 Parallel Port
The analyzer provides a parallel port to connect a printer or a floppy disk drive (a floppy disk
drive is needed to upgrade the system software; the drive can only be connected by a
Mindray-supplied cable).
2.3.7 Power Supply for the Floppy Disk Drive
It supplies power to the connected floppy disk drive. Only the drive power cable supplied by
Mindraycan be used.
2.3.8 Power Indicator
The power indicator tells you whether the analyzer is on, off or in the screen saver mode.
2.3.9 Optional Devices
Printer
An external printer can be connected to the parallel port at the left side of the analyzer. You
can use it to print out a detailed report and other desired information.
Bar-code scanner
A bar-code scanner can be connected to the RS-232 port 1 of the analyzer. You can use it to
scan the bar-coded sample IDs and reagent information into the analyzer.
zUse the printer and scanner of the specified model.
2-8
Understanding Your Analyzer
2.4 Instrument Software
2.4.1 Main Screen
After finishing the startup procedure, the analyzer enters the “Count” screen, which is the
screen to be used most frequently, hence the name is main screen.
Title Area Count Mode Area System Status Area
Error Message
Area
Title Area
The Title area displays the title of the current screen, which, in case of Figure 2-6, is “Count”.
Count Mode Area
The Count Mode area displays in which analysis (count) mode, the next sample is to be
analyzed. In case of Figure 2-6, the next sample is to be analyzed in the “Whole Blood-All”.
System Status Area
The System Status area displays whether this analyzer is ready for the next analysis. When
it displays “Ready”, it means this analyzer is ready and you can proceed to analyze the next
sample. When it displays “Waiting”, it means the analyzer is not ready for the next run yet.
When it displays “Running”, it means this analyzer is analyzing a sample.
Figure 2-6 “Count” screen
Help Area
Reagent Status
Area
System Time Area
2-9
Understanding Your Analyzer
The System Time area displays the system time.
Sample Information Area
The Sample Information area has two sub-areas, the upper titled “Current sample” and the
lower “Next sample”.
The “Current sample” refers to the sample, whose analysis result is displayed on the
“Count” screen. Its sample ID, time of analysis, analysis mode and patient information (name,
gender, age), are respectively displayed in the fields of the “Current sample” area.
The “Next Sample” refers to the sample to be analyzed next. Its sample ID and analysis
mode are displayed in the “Next sample” area.
Analysis Result Area
The Analysis Result area displays the analysis result, including histograms, of the current
sample.
Error Message Area
The Error Message area displays error messages one by one, alternating every two
seconds.
Reagent Status Area
The Reagents Status area displays how many counts the remaining reagents are enough for.
Note that when it displays “99 counts”, it indicates the reagents are enough for over 99
counts and there is also enough space left in the waste container for the counts; when it
displays “0 counts”, it indicates either at least one of the reagents is insufficient or the waste
container is full.
Menu Area
When you press [MENU], this area displays the system menu.
Help Area
The Help area reminds you how to proceed to the next step.
2.4.2 Screen saver
This analyzer will enter the screen saver if it has been idle at the “Count” screen for 10
minutes. When it happens, the sample probe will retract into the analyzer, the LCD will turn
dark and the power indicator will be flickering. You can press any key to resume the display
and reposition the sample probe.
2-10
Understanding Your Analyzer
2.4.3 System Menu
Press the [MENU] button and the system menu, shown in Figure 2-7 below, will pop up.
Figure 2-7 System menu
The system menu contains 7 programs. The programs followed by “>”s have further
sub-menus. See Figure 2-8 for the expanded menu.
Figure 2-8 Fully expanded system menu
2-11
Understanding Your Analyzer
You can select the desired program as instructed below.
If you want to… Select…
analyze samples
review sample results
run the QC program
customize system software
maintain/service the analyzer
calibrate the analyzer
shut down the analyzer
Count
Review
Quality Control
Setup
Service
Calibration
Shutdown
2-12
Understanding Your Analyzer
2.5 Reagents, Controls and Calibrator
Because the analyzer, reagents (diluent, rinse, lyse, probe cleanser and E-Z cleanser),
controls, and calibrator 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. If other reagents are used, 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.
zStore and use the reagents as directed by instructions for use of the
reagents.
z When you have changed the diluent, rinse or lyse, 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. Never use expired reagents.
z After installing new reagents, let the reagents stand for a while before using
them.
2.5.1 Diluent
The diluent is formulated to meet the following requirements:
To dilute the blood samples;
To provide the blood cells with an environment similar to the blood plasma;
To maintain the cell volume of each red blood cell and platelet during the count and
sizing portion of the measurement cycle;
To provide a conductive medium for impedance counting of white and red blood cells
and platelets.
2.5.2 Lyse
The lyse is formulated to meet the following requirements:
2-13
Understanding Your Analyzer
To rapidly break down red blood cell walls, release the hemoglobin from the cell, and
reduce the size of cellular debris to a level that does not interfere with white blood cell
counting.
To convert hemoglobin to a complex whose absorbance is determined by the
hemoglobin concentration.
2.5.3 Rinse
The rinse is formulated to rinse the bath and metering tubes and to provide proper meniscus
formation in the metering tubes and maintain it during each measurement cycle.
2.5.4 E-Z Cleanser
The E-Z (enzymatic) cleaner is an enzyme-based isotonic, cleaning solution and wetting
agent formulated to clean the fluidic lines and bath.
2.5.5 Probe Cleanser
The probe cleanser is an alkaline cleaning solution formulated to clean the fluidic lines,
apertures and bath.
2.5.6 Controls and Calibrator
The controls and calibrator are used to verify accurate operation of and calibrate the
analyzer.
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. Controls and calibrators can be purchased from
Mindray or Mindray-authorized distributors.
2-14
3 Understanding the System
Principles
3.1 Introduction
The two independent measurement methods used in this analyzer are:
the impedance method for determining the WBC, RBC, and PLT data;
the colorimetric method for determining the HGB.
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
This analyzer can process two types of blood samples – whole blood samples and prediluted
blood samples.
If you are going to analyze a whole blood sample, you can simply present the sample to the
sample probe and press the aspirate key to aspirate 13µL of the sample into the analyzer.
If you are going to analyze a capillary blood sample, you should first manually dilute the
sample (20 µL of capillary sample needs to be diluted by 1.6 mL of diluent) and then present
the pre-diluted sample to the sample probe and press the aspirate key to aspirate 0.7 mL of
the sample into the analyzer.
3-2
Understanding the System Principles
3.3 Dilution
Usually in blood samples, the cells are too close to each other to be identified or counted. For
this reason, the diluent is used to separate the cells so that they are drawn through the
aperture one at a time as well as to create a conductive environment for cell counting.
Moreover, red blood cells usually outnumber white blood cells by 1,000 times. For this reason,
lyse needs to be added to the sample to eliminate the red cells before the WBC counting.
3-3
Understanding the System Principles
3.4 WBC/HGB Measurement
3.4.1 Volumetric Metering
An accurate cell count cannot be obtained unless the precise volume of diluted sample that
passes through the aperture during the count portion of the analysis cycle (the count cycle) is
known. This analyzer uses a volumetric metering unit to control the count cycle and to ensure
that a precise volume of sample is analyzed.
The metering unit controlling the WBC count cycle consists of a metering tube with two
optical sensors mounted on it, as Figure 3-1 shows. 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 rinse is used to create a meniscus in the
metering tube. The count cycle starts when the meniscus reaches the upper sensor and
stops when the meniscus reaches the lower sensor. The amount of time required for the
meniscus to travel from the upper sensor to the lower sensor is called the WBC 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 (see Chapter 5.3 for details). If the former
is less than or greater than the latter by 2 seconds or more, the analyzer will report WBC
bubbles or WBC clog error. Seeing the error message, you can refer to Chapter 11
Troubleshooting Your Analyzer for solutions.
Figure 3-1 Volumetric metering process
3-4
Understanding the System Principles
3.4.2 Measurement Principles
WBC measurement
WBCs are counted and sized by the impedance method, as Figure 3-2 shows. This method is
based on the measurement of changes in electrical resistance produced by a particle, which
in this case is a blood cell, suspended in a conductive diluent as it passes through an
aperture of known dimensions. An electrode is submerged in the liquid on both sides of the
aperture to create an electrical pathway. As each particle passes through the aperture, a
transitory change in the resistance between the electrodes is produced. This change
produces a measurable electrical pulse. The number of pulses generated indicates the
number of particles that passed through the aperture. The amplitude of each pulse is
proportional to the volume of each particle. Each pulse is amplified and compared to the
internal reference voltage channels, which only accepts the pulses of certain amplitude. If the
pulse generated is above the WBC threshold, it is counted as a WBC.
Figure 3-2 Impedance method of counting and sizing
HGB measurement
HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the
bath where it is bubble mixed with a certain amount of lyse, which converts hemoglobin to a
hemoglobin complex that is measurable at 525 nm. An LED is mounted on one side of the
bath and emits a beam of monochromatic light, whose central wavelength is 525nm, and then
is measured by a photo-sensor that is mounted on the opposite side. The signal is then
amplified and the voltage is measured and compared to the blank reference reading
(readings taken when there is only diluent in the bath). The HGB is calculated per the
following equation and expressed in g/L.
3-5
Understanding the System Principles
HGB(g/L) = Constant×Log
(Blank Photocurrent/Sample Photocurrent)
10
3.4.3 Derivation of WBC-Related Parameters
WBC
WBC (10
passing through the aperture.
Note that NRBCs do not react with the lyse and can be mistaken by the analyzer for white
blood cells. If you observe NRBCs in the microscope, correct the system-generated result by
the following formula,
where WBC represents the system-generated white cell number, NRBC the number of
NRBCs counted in 100 white cells and WBC′ the corrected white cell number.
9
/ L) is the number of leukocytes measured directly by counting the white blood cells
9
WBC'WBC
=×
×=
100
+
L/10nWBC
NRBC100
WBC differentia
With the help of the diluent and lyse, this analyzer can size the white cells into three
sub-populations - lymphocytes, mid-sized cells (including monocytes, basophils and
eosinophils) and granulocytes. Based on the WBC histogram, this analyzer calculates Lymph
%, Mid% and Gran% as follows and express the results in percents.
PM
PG
PL
++
100
PGPMPL
++
100
PGPMPL
100
PGPMPL
++
9
L/10
)
9
L/10
)
9
L/10
).
where PL = particles in the lymphocyte region(
PM = particles in the mid size region(
PG = particles in the granulocyte region(
Lymph%×
Mid%×
Gran%×
=
=
=
Having achieved the three parameters above, this analyzer proceeds to calculate the
Lymph# , Mid# and Gran# per the following equations and express them in
3-6
9
L/10
.
Understanding the System Principles
×
×
×
=
WBC histogram
Besides the parameters mentioned above, this analyzer also presents a WBC histogram,
whose x-coordinate represents the cell volume(fL)and y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result area of the “Count” screen
when the analysis is done. You can also review the histograms of the stored patient results
(see Chapter 7 Reviewing Sample Results).
The first three discriminators of the WBC histogram can be adjusted in case you are not
satisfied with the result. Note that you cannot adjust them if the WBC result is less than 0.5 or
out of the operating range.
#Lymph
=
#Mid
100
=
#Gran
100
WBC%Lymph
100
WBC%Mid
WBC%Gran
3.4.4 HGB
Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L) as
follows.
HGB (g/L)=Constant×Log
(Blank Photocurrent/Sample Photocurrent)
10
3-7
Understanding the System Principles
3.5 RBC/PLT Measurement
3.5.1 Volumetric Metering
An accurate cell count cannot be obtained unless the precise volume of diluted sample that
passes through the aperture during the count cycle is known. This analyzer uses a volumetric
metering unit to control the count cycle and to ensure that a precise volume of sample is
analyzed for the measurement.
The metering unit controlling the RBC/PLT count cycle consists of a metering tube with two
optical sensors mounted on it, as Figure 3-3 shows. 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 rinse is used to create a meniscus in the
metering tube. The count cycle starts when the meniscus reaches the upper sensor and
stops when the meniscus reaches the lower sensor. The amount of time required for the
meniscus to travel from the upper sensor to the lower 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 (see Chapter 5.3for details). If the former
is less than or greater than the latter by 2 seconds or more, the analyzer will report RBC
bubbles or RBC clog error. Seeing the error message, refer to Chapter 11 Troubleshooting
Your Analyzer for solutions.
Figure 3-3 Volumetric metering process
3-8
Understanding the System Principles
3.5.2 Measurement Principles
RBC/PLT measurement
RBCs/PLTs are counted and sized by the impedance method, as Figure 3-4 shows. This
method is based on the measurement of changes in electrical resistance produced by a
particle, which in this case is a blood cell, suspended in a conductive diluent as it passes
through an aperture of known dimensions. An electrode is submerged in the liquid on both
sides of the aperture to create an electrical pathway. As each particle passes through the
aperture, a transitory change in the resistance between the electrodes is produced. This
change produces a measurable electrical pulse. The number of pulses generated indicates
the number of particles that passed through the aperture. The amplitude of each pulse is
proportional to the volume of each particle. Each pulse is amplified and compared to the
internal reference voltage channels, which only accepts the pulses of a certain amplitude. If
the pulse generated is above the RBC/PLT lower threshold, it is counted as an RBC/PLT.
Figure 3-4 Impedance method of counting and sizing
3.5.3 Derivation of RBC-Related Parameters
RBC
12
RBC (10
passing through the aperture.
MCV
Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
/L) is the number of erythrocytes measured directly by counting the erythrocytes
3-9
Understanding the System Principles
×
expresses the result in fL.
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows:
=
Where the RBC is expressed in 10
RDW-CV
Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation) of the
erythrocyte distribution width.
HCT
MCH =
MCHC×=
MCVRBC
10
HGB
RBC
HGB
100
HCT
12
/L, MCV in fL and HGB in g/L.
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 3-5 shows.
Figure 3-5 RBC Distribution Width – Standard Deviation
RBC Histogram
Besides the parameters mentioned above, this analyzer also presents an RBC histogram,
whose x-coordinate represents the cell volume(fL)and y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result area of the “Count” screen
when the analysis is done. You can also review the histograms of the stored patient results
(see Chapter 7 Reviewing Sample Results).
The two discriminators of the RBC histogram can be adjusted in case you are not satisfied
with the result. Note that you cannot adjust them if the RBC result is less than 0.2 or out of the
operating range.
3-10
Understanding the System Principles
3.5.4 Derivation of PLT-Related Parameters
PLT
PLT (10
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
9
/L) is measured directly by counting the platelets passing through the aperture.
This analyzer calculates the PCT as follows and express it in %.
9
Where the PLT is expressed in 10
PCT
=
/L and the MPV in fL.
MPVPLT
×
10000
PLT Histogram
Besides the parameters mentioned above, this analyzer also presents a PLT histogram,
whose x-coordinate represents the cell volume(fL)and y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result area of the “Count” screen
when the analysis is done. You can also review the histograms of the stored patient results
(see Chapter 7 Reviewing Sample Results).
The two discriminators of the PLT histogram can be adjusted in case you are not satisfied
with the result. Note that you cannot adjust them if the PLT result is less than 10 or out of the
operating range.
3-11
Understanding the System Principles
3.6 Wash
After each analysis cycle, each element of the analyzer is washed.
The sample probe is washed internally and externally with diluent;
The bath is washed with diluent and rinse;
The metering tube is washed with rinse;
The rest of the fluidic system is washed by diluent.
3-12
4 Installing Your Analyzer
4.1 Introduction
This chapter introduces how to install the BC-2800. To ensure all system components
function correctly and to verify system performance, Mindray-authorized representatives will
handle the installation and initial software setup.
zInstallation by personnel not authorized or trained by Mindray may damage
your analyzer. Do not install your analyzer without the presence of
Mindray-authorized personnel.
4-1
Installing Your Analyzer
4.2 Installation Requirements
Before installation, you should ensure that the following space, power and environmental
requirements are met.
4.2.1 Space Requirements
Check the site for proper space allocation. In addition to the space required for the analyzer
itself, arrange for
at least 28 cm on each side, which is the preferred access to perform service
procedures;
at least 10 cm behind for cabling and ventilation;
enough room on or below the countertop to accommodate the diluent, rinse and waste
containers.
4.2.2 Power Requirements
Check the availability of a power outlet that meets the following requirements
Voltage: 100 to 240 VAC;
Frequency: 50/60±1 Hz
Power: 180VA
Fuse: 250V T4A
z Make sure the analyzer is properly grounded.
z Replace fuse only with the type and rating specified.
z Make sure the electrical outlet meets the requirements.
z Before connecting the power cord, make sure the power switch at the back
of the analyzer is placed in the off (O) position.
4-2
Installing Your Analyzer
4.2.3 General Environment
Operating temperature: 15 ℃ to 30 ℃.
Relative humidity: 30% to 85%.
Atmospheric pressure: 60 kPa to 106 kPa.
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 place the analyzer in direct sunlight or in front of a source of heat or drafts.
z Do not place the analyzer in a flammable or explosive environment.
z Do not place any container on the top of the analy zer.
z If the ambient temperature is outside the specified operating range, the
analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting Your Analyzer for
solutions.
4-3
Installing Your Analyzer
4.3 Unpacking
4.3.1 Unpacking and Inspecting the Analyzer
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. When you
are sure the carton is fine, follow the steps below to unpack the analyzer:
Place the carton on the floor upright with the arrows on the side upwards;
Remove the tape and take out the accessory box. Check the accessories against the
packing list. Notify the Mindray customer service department or your local distributor
immediately if you find anything missing;
Open the main box and check the items inside against the packing list. Notify the
Mindray customer service department or your local distributor immediately if you find
anything missing;
Remove the top protective foam, carefully carry out the analyzer from the box and place
it on the countertop.
Remove the foam fixing the sample probe.
z Retain the shipping carton and all the packing materials, as they can be
used for packaging if analyzer must be reshipped.
4.3.2 How to move the analyzer
If the carton is intact, you may use a plate and fork-lifter to move the analyzer for a short
distance.
If your analyzer has been used, do the ”Empty tubing” procedure and shut it down
before moving it.
For a short - distance moving on a smooth ground, you may use a trolley to facilitate the
transportation.
During the moving process, protect the LCD and the sample probe from excessive force
and from contact with other objects.
Keep the analyzer upright during the moving process. Do not tilt or incline it.
Do your best to minimize the mechanical shock when moving the analyzer. After a
long-distance moving, check and tune the analyzer before using it.
4-4
Installing Your Analyzer
4.4 Installation Procedure
z Dispose of reagents, waste, samples, consumables, etc. according to
government regulations.
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 Use the specified reagents.
z After installing new reagents, keep the reagents still for a while before using
them.
z Never use expired reagents.
z T o prevent c ont amination, tighte n the cont ainer c ap s when the inst allation is
finished.
z Samples, controls, calibrator and waste are potentially infectious. Wear
proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.
4.4.1 Connecting Regents
On the back of the instrument you will find a fluidic connection equipped with 4 plastic plugs.
These plugs are closed by protection caps to prevent dust and the leaking of liquids during
transportation. Take off these caps by unscrewing them and keep them in a safe place for
future transportation.
Connecting the diluent container
1. Take out the diluent pickup tube (the one with a green connector) from the accessory box
4-5
Installing Your Analyzer
(Figure 4-1);
Figure 4-1 Diluent container
2. Take out the diluent container and place it on or below the countertop;
3. Remove the container cap and insert the tube end that has no connector into the diluent
container and tighten the cap until properly secured, as Figure 4-2 shows;
Figure 4-2 Insert the tube end into the container
4. Locate the green fitting marked “DILUENT” in the lower right corner of the back of the
analyzer;
5. Plug the green connector of the tube into the fitting and turn it clockwise until properly
secured.
Connecting the rinse container
1. Take out the rinse pickup tube (the one with a blue connector) from the accessory box, as
Figure 4-3 shows;
4-6
Installing Your Analyzer
Figure 4-3 Rinse container
2. Take out the rinse container and place it on or below the countertop;
3. Remove the container cap and insert the tube end that has no connector into the rinse
container and tighten the cap until properly secured, as Figure 4-4 shows;
Figure 4-4 Insert the tube end into the container
4. Locate the blue fitting marked “RINSE” in the lower right corner of the back of the
analyzer.
5. Plug the blue connector of the tube into the fitting and turn it clockwise until properly
secured.
Connecting the lyse container
1. Take out the lyse pickup tube (the one with an orange connector) from the accessory box,
as Figure 4-5 shows;
4-7
Installing Your Analyzer
Figure 4-5 Lyse container
2. Take out the lyse container;
3. Remove the container cap and insert the tube end that has no connector into the
container and tighten the cap until properly secured, as Figure 4-6 shows;
Figure 4-6 Insert the tube into the container
4. Locate the orange fitting marked “LYSE” in the lower right corner of the back of the
analyzer;
5. Plug the orange connector of the tube into the fitting and turn it clockwise until properly
secured.
Connect the waste container
1. Take out the waste tube (the one with a red connector) from the accessory box;
2. Locate the red fitting marked “WASTE” in the lower right corner of the back of the
analyzer;
3. Plug the red connector of the tube into the fitting and turn it clockwise until properly
secured;
4. Prepare a container to receive the waste and place it on or below the countertop;
5. Insert the waste tube into the waste container.
4-8
Installing Your Analyzer
4.4.2 Installing Recorder Paper
z Remove the protective paper between the recorder head and the roller
inside the recorder before installing recorder paper.
Follow the procedure below to install the recorder paper.
1. Use the latch at the upper right corner of the recorder door to pull the door open.
2. Insert a new roll into the compartment as shown below.
3. Close the recorder door.
4. Check if paper is installed correctly and the paper end is feeding from the top.
Paper roll
Figure 4-7 Installing recorder paper
zUse only specified recorder paper. Otherwise, it may cause damage to the
recorder head, or the recorder may be unable to print, or poor print quality
may result.
zNever pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.
zDo not leave the recorder door open unless you install paper or remove
trouble.
z Improper installation of recorder paper may jam the paper and/or result in
blank printout.
4-9
Installing Your Analyzer
4.4.3 Connecting the Keyboard
Take out the keyboard from the accessory kit and connect it to the keyboard interface marked
“KB”.
4.4.4 Connecting the Printer (Optional)
Follow the printer’s instructions for use to connect the printer to the parallel port.
4.4.5 Connecting the Bar-Code Scanner (Optional)
Follow the scanner’s instructions for use to connect the scanner to the serial port1.
zUse the printer and scanner of the specified model.
4-10
Installing Your Analyzer
4.5 Starting the Analyzer
Take out the power cord from the accessory box. Plug the non-pronged end into the AC input
at the back of the analyzer and the pronged end into an electrical outlet. Place the power
switch at the back of the analyzer in the ON position (1) to turn on the analyzer. The power
indicator light will be illuminated and the screen will display “Initializing…“. The analyzer will
sequentially initialize the file, hardware and fluidic systems and the whole initializing process
lasts about 4 to 7 minutes. When the initialization is finished, the analyzer will automatically
enter the “Count” screen.
4-11
5 Customizing the Analyzer Software
5.1 Introduction
The BC-2800 is a flexible laboratory instrument that can be tailored to your work environment.
You can use the “Setup” program to customize the software options as introduced in
Chapters5.2 to 5.3.
5-1
Customizing the Analyzer Software
5.2 Password
The BC-2800 classifies users into two categories: common users (default) and administrators.
You need to enter the administrator password to adjust certain options such as “Count”,
“Gain”, etc.
5.2.1 Entering the Administrator Password
Press [MENU] to enter the system menu.
Figure 5-1 System menu
SELECT “Setup → Password” ( Figure 5-1 ) to enter the ”Password” screen ( Figure 5-2 ).
Figure 5-2 “Password” screen
ENTER “2826” and press [MENU], a message box will pop up to remind you of the current
password level, as Figure 5-3 shows, to remind you of the current password level,
5-2
Customizing the Analyzer Software
Figure 5-3 A message box to confirm the user level
CLICK “Yes”to confirm the password andexit to the system menu.
5.2.2 Resuming the Common User Password
Enter the “Password” screen and the default password is the common user password. Press
[MENU] again and a message box will pop up to remind you of the current password level, as
Figure 5-4 shows.
Figure 5-4 A message box to confirm the user level
CLICK “Yes”to confirm the password andexit to the system menu.
5-3
Customizing the Analyzer Software
5.3 Editing Settings
You can use the “Settings” menu to edit system settings.
Press [MENU] to enter the system menu. SELECT “Setup→Settings“, as Figure 5-5 shows,
to enter the “Settings” screen, as Figure 5-6 shows.
Figure 5-5 System menu
Figure 5-6 “Settings” screen
This screen can be interpreted as follows:
Setting Groups area (on the left)
This area displays the visible or changeable setting groups. You can press [F1] to select the
desired group. The selected group is preceded by a ⊙.
Settings area (on the right)
You can change the settings of the items displayed in this area.
Help area (on the bottom)
5-4
Customizing the Analyzer Software
This area displays useful information to help you move to the next step.
At this screen, if you want to acquire help information, press [HELP]; if you want to return to
the system menu, press [MENU].
5.3.1 Reagent
You can select the “Reagent” group to change the settings regarding the reagents and the
waste, as Figure 5-7 shows.
Figure 5-7 “Reagent” settings
Selecting the “Reagent” group
Press [F1] to select the “Reagent” group.
Setting remaining volumes for reagents
You may set the remaining volumes for the diluent, rinse and lyse. When any of the entered
volumes is counted down to zero, the system will remind you to install a new container.
1. SELECT “Diluent”, “Rinse” or “Lyse” in the “Remains” field as needed;
2. ENTER the desired digits. See Table 5-1 for the valid reagent volumes.
Table 5-1 Valid reagent volumes
Allowed range
Entering the usable volume of the waste container
About 0 to 30.0 L About 0 to 30.0 L About 0 to 999.0 mL
Diluent Rinse Lyse
You may enter the usable volume of the waste container. When the system counts down the
entered volume to 0, it will alert you to empty the waste container. Follow the steps given
below to set the volume.
5-5
Customizing the Analyzer Software
1. SELECT “Waste Cont ainer”;
2. ENTER the desired digits.
Entering expiration dates of reagents
You can specify the expiration dates for the diluent, rinse and lyse. Once any of these
reagents is expired, the system will alert you to install a new container. Follow the steps given
below to enter the expiration dates.
1. SELECT “Exp. Date”;
2. ENTER the desired digits. You can use the bar-code scanner (if available) to scan the
bar-code of the reagents into the analyzer;
3. Note that open reagents are stable for 60 days. The entered expiration date should be
the open date + 60 days or the expiration date marked on the packaging of the reagent,
whichever is earlier.
Exiting the “Reagent” group
When you have finished changing all the desired reagent settings, you may
1. Press [F1] to select another setting group you want to change; or
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-8 shows. CLICK “Yes” to save the changes and exit to the system menu; or
CLICK “No” to exit to the system menu without saving the changes.
Figure 5-8 Saving changes
Note that if any entered value is beyond the valid range, a message box will pop up after you
have pressed [MENU]. CLICK “Yes” to close the message box and clear the invalid values.
Figure 5-9 A message box to remind you of the erroneous entry
5.3.2 Printing and Communication Settings
You can select the “Print & comm.” group to change the printing and communication settings
5-6
Customizing the Analyzer Software
to your own need, as Figure 5-10 shows.
Figure 5-10 Printing and communication settings
Selecting the “Print & comm.” group
Press [F1] to select the “Print & comm.” group.
Selecting the printing device
To select a printing device, SELECT “Recorder” or “Printer” from the “Device” drop-down list, as Figure 5-10 shows.
Selecting the printing format
If you have selected the printer, you can choose either of the following printing formats.
1. Format1 - One page with histogram;
2. Format2 - One page without histogram.
To select a printing format, SELECT desired format from the “Format” drop-down list,
If you have selected the recorder, you can choose any of the following 4 printing formats.
1. Format1 - parameter values + histograms;
2. Format2 – parameter values only;
3. Format3 - parameter values + histograms;
4. Format4 - parameter values only.
To choose the desired format, SELECT the desired format from the “Format” pull-down list,
as Figure 5-11 shows.
5-7
Auto printing
Customizing the Analyzer Software
Figure 5-11 Selecting printing format
The auto printing function refers to the analyzer’s ability to automatically print out the analysis
results once they are done. To activate this function, SELECT “ON” (or “OFF”) from the
“Auto” pull-down list, as Figure 5-12 shows.
Figure 5-12 Selecting auto-printing
Setting baud rate
To choose one of the four baud rates, “19200”, “9600”, “4800”, “2400” and “1200”, SELECT
the desired baud rate from the “Baud” drop-down list, as Figure 5-13 shows.
5-8
Customizing the Analyzer Software
Figure 5-13 Selecting baud rate
Selecting parity
To choose the “Odd”, “Even” or “None” (default) check, SELECT the desired check from the
“Parity” drop-down list, as Figure 5-14 shows.
Figure 5-14 Setting parity
Activating/deactivating handshake
If the “Handshake” function is activated, to start the transmission this analyzer will send a
handshake signal to an external computer and wait for the response. If the computer does not
respond, this analyzer will abort the transmission and give an alarm for the transmission error.
If the “Handshake” function is deactivated, this analyzer will transmit data to the external
computer regardless of the response. This function is deactivated by default.
5-9
Customizing the Analyzer Software
To activate or deactivate this option, SELECT “Yes” or ”No” from the “Handshake” drop-down list, as Figure 5-15 shows.
Figure 5-15 Setting handshake
Auto Communication
The auto communication function refers to the analyzer’s ability to automatically transmit the
analysis results to an external computer once they are done. To activate or deactivate this
function, SELECT “On” or ”Off” from the “Auto” drop-down list in the “Transmit” field, as
1. SELECT “Recorder” or ”Printer” in the “Report Title” field, depending on the selected
5-10
Customizing the Analyzer Software
printing device;
2. ENTER the desired report title.
Exiting the “Print & comm.” group
When you have finished changing all the desired printing and transmission settings, you may
press [F1] to select another setting group you want to change; or press [MENU] and a
message box will pop up to remind you to save the changes, as Figure 5-17 shows. CLICK
“Yes” to save the changes and exit to the system menu; or CLICK “No” to exit to the system
menu without saving the changes.
Figure 5-17 Saving changes
5.3.3 Date and Time
You can select the “Date & time” group to set the system date and time, as Figure 5-18
shows. Follow the instructions given below to do so.
Figure 5-18 Setting date and time
Selecting the “Date & time” group
Press [F1] to select the “Date & time” group.
Setting the system date
1. SELECT “Year”, ” Month” or ”Day”;
2. ENTER the desired digits.
5-11
Customizing the Analyzer Software
Selecting the date format
You may choose one of the three formats “YYYY-MM-DD”, “MM-DD-YYYY“ and
“DD-MM-YYYY”. To do so, SELECT the desired format from the “Format” drop-down list,
as Figure 5-19 shows.
Figure 5-19 Setting date format
Setting the system time
1. SELECT “Hour”, “Minute” or “Second”;
2. ENTER the desired digits.
Exiting the “Date & time” group
When you have finished changing all the desired date and time settings, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-20 shows. CLICK “Yes” to save the changes and exit to the system menu; or
CLICK “No” to exit to the system menu without saving the changes.
Figure 5-20 Saving changes
5-12
Customizing the Analyzer Software
5.3.4 Gain
You can select the “Gain” group to view or change (if you have the administrator password)
the WBC, RBC and HGB gains.
Figure 5-21 Setting gain
Selecting the “Gain” group
Press [F1] to select the “Gain” group, as Figure 5-21 shows.
Setting the WBC gain
When WBC histograms of most samples are similar to Figure 5-22, it implies too small a
WBC gain and you need to increase the gain appropriately.
Figure 5-22 WBC gain too small
When WBC histograms of most samples are similar to Figure 5-23, it implies too large a WBC
gain and you need to decrease the gain appropriately.
Figure 5-23 WBC gain too large
5-13
Customizing the Analyzer Software
To increase (or decrease) the gain
1. Enter the administrator password as introduced in Chapter 5.2.1.
2. At the ”Gain” screen and ENTER the desired gain into the “WBC (WB) ”, as Figure 5-24
shows, or “WBC (PB)”, as Figure 5-25 shows.
Figure 5-24 Setting WBC (WB) gain
Figure 5-25 Setting WBC (PB) gain
Setting the RBC gain
When the difference between the actual MCV result and the expected result exceeds 6%,
you need to change the RBC gain.
5-14
Customizing the Analyzer Software
For example, assuming the expected MCV result is 90.0fL, while the actual analysis result is
82.0fL, then
VExpectedMC
%100=××=
ActualMCV
You should adjust the RBC gain to 109.8% as close as possible. Follow the steps given below
to do so.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the “Settings” screen, press [F1] to select the “Gain” group;
3. SELECT “RBC”, as Figure 5-26 shows;
4. ENTER the desired gain so that the adjustment becomes as close to 109.8% as possible.
0.90
%8.109%100
0.82
Figure 5-26 Setting RBC gain
Setting the HGB gain
You may adjust the HGB gain to change the HGB blank voltage, which usually should be set
between 3.4 to 4.8V (4.5V recommended). Follow the steps given below to set the HGB gain.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the “Settings” screen, press [F1] to select the “Gain” group;
3. SELECT “HGB”;
4. ENTER the desired gain so that the HGB blank voltage is between 3.4 to 4.8V, as Figure
5-27 shows.
5-15
Exiting “Gain” group
Customizing the Analyzer Software
Figure 5-27 Setting HGB gain
When you have finished changing all the desired gain settings, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-28 shows. CLICK “Yes” to save the changes and exit to the system menu; or
CLICK “No” to exit to the system menu without saving the changes.
Figure 5-28 Saving changes
5.3.5 Count
You can select the “Count” group to view or change (if you have the administrator password)
the parameter units and count time.
5-16
Customizing the Analyzer Software
Figure 5-29 Setting unit and count time
Selecting the “Count” group
Press [F1] to select the “Count” group, as Figure 5-29 shows.
Selecting parameter units
This analyzer provides multiple units for certain parameters. Refer to Table 5-2 for all the
selectable units of all parameters. The 19 parameters are divided into 11 groups based on
their units and you can only select unit for the first parameter of a group. Pay special attention
to the HGB group, which includes HGB, MCHC and MCH. When you select g/L or g/dL as the
unit of HGB, the default unit for MCH is pg; when you select mmol/L as the unit of HGB, the
default unit of MCH is fmol.
Table 5-2 Units of Parameters
Parameter Display format Unit Remarks
WBC
Lymph#
Mid#
Gran#
***.* 109/L Default
***.* 103/uL /
**** 102/uL /
***.* /nL /
Mid%
Gran%
HGB, MCHC
**.* Lymph%
.***
%
Default
*** g/L Default
**.* g/dL /
**.* mmol/L /
5-17
Customizing the Analyzer Software
RBC
*.** 1012/L Default
*.** 106/uL /
*** 104/uL /
*.** /pL /
**.* % Default HCT
.*** L/L /
***.* fL Default MCV, RDW-SD
***.* um
3
/
RDW-CV **.* % Default
PLT
**** 109 /L Default
**** 103 /uL /
***.* 104 /uL /
**** /nL /
***.* fL Default MPV
***.* um3 /
PDW **.* / Default
.*** % Default PCT
*.** mL/L /
MCH
*.*** pg Default
**.** fmol /
Follow the steps given below to select the units.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the “Settings” screen, press [F1] to select the “Count” group;
3. SELECT the desired unit from the drop-down list of the desired parameter, as Figure
5-30 shows.
5-18
Setting count time
Customizing the Analyzer Software
Figure 5-30 Selecting parameter unit
If the WBC or RBC count time is inappropriately set, the system may give false alarms for
clogs or bubbles. When this happens, follow the steps given below to change the WBC or
RBC count time. Refer to the actual count time (see Chapter 10.5.1 for details) when editing
the count time. Follow the steps given below to set the count time.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the “Settings” screen, press [F1] to select the “Count” group;
3. SELECT “WBC” or “RBC”, as Figure 5-31 shows;
4. ENTER the desired digits.
Exiting the “Count” group
Figure 5-31 Setting count time
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Customizing the Analyzer Software
When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-32 shows. CLICK “Yes” to save the changes and exit to the system menu; or
CLICK “No” to exit to the system menu without saving the changes.
Figure 5-32 Saving changes
5.3.6 Reference Range
You can set a reference range for every parameter. The system will flag any analysis result
that exceeds this range with either an H or L. This analyzer divides the patients into 5 patient
groups, which are all listed in Table 5-3. The default ranges are given. Note that the default
ranges are for references only. Each laboratory is encouraged to establish its own
references.
Table 5-3 Demographic groups
Group Gender Age
Not specified, male or female. Not specified. General
Not specified.
Man Male
Woman Female
> 12 years
> 12 years
> 12 years
Child Male or Female
Neonate Male or Female
The upper and lower limits of the reference ranges are visible to all users but changeable
5-20
> 28 days and ≤12 years
≤ 28 days
Customizing the Analyzer Software
only to administrators, as Figure 5-33 shows. Follow the instructions below to set the ranges.
Figure 5-33 Reference range screen
Selecting patient group
Follow the steps given below to select the patient group you want.
1. At the “Settings” screen, press [F1] to select the “Ref. Range” group.
2. SELECT the combo box to the right of “Group”.
Figure 5-34 Selecting patient group
3. SELECT “General”, “Man”, “Woman”, “Child” or “Neonate” from the “Group”
pull-down list.
5-21
Customizing the Analyzer Software
Setting reference ranges (administrators only)
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the “Settings” screen, press [F1] to select the “Ref. Range” group, as Figure 5-35
shows;
3. When you have finished selecting the patient group, SELECT the desired parameter and
ENTER the desired digits for the upper and lower limits;
Figure 5-35 Setting reference range
4. Press [F2] to save the changes. If the changes are successfully saved, a message box
shown in Figure 5-36 will pop up; CLICK the “Yes” to close the message box;
Figure 5-36 A message box to note data saved
5. If some entered limits are invalid, a message box shown in Figure 5-37 will pop up.
CLICK “Yes” and enter valid number again;
5-22
Customizing the Analyzer Software
Figure 5-37 A message box to remind you of the erroneous entry
6. If you want to resume the default settings, press [F4].
Exiting the “Ref. Range” group
When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] to exit to the system menu.
5.3.7 Auto Maintain
You can select “Auto Maintain” group to view or set the how many WB samples can be run
after perform auto maintaining.
Selecting “Auto Maintain” group
Press [F1] to select the “Auto Maintain” group.
Figure 5-38 “Auto Maintain” screen(1)
The screen displays:
1) how many WB samples had been run after auto-cleaning and how many WB
samples can be run between two auto-cleanings;
2) how many WB samples had been run and how long the analyzer run after soak by
probe cleanser
5-23
Customizing the Analyzer Software
3) how many WB samples had been run after probe wipe cleaning.
For more information about auto maintain, see Chapter 10 Maintaining Y our Analyzer for
detail.
Change the WB samples can be run between two cleanings
1. Enter the administrator password as introduced in Chapter 5.2.1.
2. At the “Settings” screen, press [F1] to select the “Auto Maintain” group, as Figure 5-39
shows.
3. ENTER the desired digits.
Figure 5-39 Auto maintain screen(2)
Exiting the “Auto Maintain” group
When you have finished the changing, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-40 shows. CLICK “Yes” to save the changes and exit to the system menu; or
CLICK “No” to exit to the system menu without saving the changes.
Figure 5-40 Saving changes
5-24
Customizing the Analyzer Software
5.3.8 Other Settings
You can select the “Other” group to view or change other settings.
Selecting the “Other” group
Press [F1] to select the “Other” group.
Muting beeper
This analyzer beeps when an error occurs. You can mute the beeper by pressing any key or
leave it beeping until the errors are removed. If you prefer the former, SELECT “Enabled”
from the “Any key to mute” drop-down list ; if you prefer the latter, SELECT “Disabled”
from the “Any key to mute” drop-down list. See Figure 5-41 shows.
Figure 5-41 Selecting how to mute the beeper
Selecting LCD contrast
Follow the steps given below to adjust the LCD contrast.
1. SELECT “LCD contrast”, as Figure 5-42 shows;
2. ENTER the desired contrast (0 to 255).
5-25
Customizing the Analyzer Software
Figure 5-42 Select LCD contrast
Setting alarm time
Follow the steps given below to set for how long (2s to120s) the error messages listed in
Table 5-4 should be displayed on the screen.
Table 5-4 Error List
No. Error No.Error No.Error
1 Communication Error 2 Scanner Error 3 Scanner
Communication Error
4 Environmental
5 Background Abnormal 6 HGB Error
Temperature Abnormal
7 HGB Adjustment 8 WBC Clog 9 WBC Bubbles
10 RBC Clog 11 RBC Bubbles
1. SELECT “Alarm time(s)”, as Figure 5-43 shows;
2. ENTER the desired digits.
5-26
Customizing the Analyzer Software
Figure 5-43 Setting alarm time
Selecting PMB color (administrator password needed)
The PMB color refers to the background color of the screen when your analyzer is in the
prediluted mode. Follow the steps below to select the PMB color.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the “Settings” screen, press [F1] to select the “Other” group;
3. SELECT “Black” (default) or “Blue” from the “PMB color” drop-down list, as Figure
5-44 shows.
Figure 5-44 Setting PMB color
Delete data information list
You can delete the information in the list of “Dept.”, “Sender”, “Tester” and “Checker” stored
5-27
Customizing the Analyzer Software
in the edit window when input patient information.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the “Settings” screen, press [F1] to select the “Other” group;
3. SELECT “Not Delete” (default) or “Delete All” from the “Info. In list of Dept., Sender
etc.” drop-down list, as Figure 5-45 shows.
Figure 5-45 Delete the information
Exiting the “Other” group
When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-46 shows. SELECT “Yes” to save the changes and exit to the system menu; or SELECT “No” to exit to the system menu without saving the changes.
5-28
Customizing the Analyzer Software
Figure 5-46 Saving changes
5-29
6 Operating Your Analyzer
6.1 Introduction
This chapter provides step-by-step procedures for operating your analyzer on a daily basis.
Initial Checks
Power on
Daily Quality Control
Sample Collection and Handling
Whole Blood Mode?
Yes
Run Whole Blood Samples
Shutdown
No
Run Prediluted Samples
6-1
Operating Your Analyzer
6.2 Initial Checks
Perform the following checks before turning on the analyzer.
1. Check and make sure the waste container is empty;
2. Check and make sure there are enough reagents;
zSamples, controls, calibrator and waste are potentially infectious. Wear
proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.
z Dispose of reagents, waste, samples, consumables, etc. according to
government regulations.
3. Checking tubing and power connections ;
Check and make sure the diluent, rinse and waste tubes are properly connected and not
bent;
Check and make sure the power cord of the analyzer is properly plugged into an
electrical outlet.
4. Checking the printer (optional) and recorder;
Check and make sure enough printer or recorder paper is installed. Check and make sure the
power cord of the printer is properly plugged into an electrical outlet. Check and make sure
the printer cable is properly connected to the analyzer.
5. Check keyboard connection.
Check and make sure the keyboard is properly connected to the keyboard interface (marked
“KB”) of the analyzer.
6-2
Operating Your Analyzer
6.3 Power-on
Place the power switch at the back of the analyzer in the ON position (1) to turn on the
analyzer. The power indicator light will be illuminated and the screen will display
“Initializing…“.
The analyzer will sequentially initialize the file, hardware and fluidic systems and the whole
initializing process lasts 4 to 7 minutes, depending on how the analyzer was previously shut
down.
If any error occurs during the initialization, the analyzer will display the error messages in the
lower left corner of the screen. You should remove all the errors before running any sample.
See Chapter 11 Troubleshooting Your Analyzer for solutions.
zRunning samples with the abnormal background error present will lead to
unreliable results.
6-3
Operating Your Analyzer
6.4 Daily Quality Control
Before running any samples, run the controls. See Chapter 8 Using the QC Programs for
details.
6-4
Operating Your Analyzer
6.5 Selecting Analysis Mode
At the “Count” screen, press [MODE] to select one of the six analysis modes. The selected
mode will be displayed in the Count Mode area.
1. Whole - All
It means the sample to be analyzed is a whole blood sample and all the 19 parameters are to
be analyzed.
2. Whole - WBC/HGB
It means the sample to be analyzed is a whole blood sample and only the following
parameters are analyzed: WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran% and HGB,
plus the WBC histogram.
3. Whole -RBC/PLT
It means the sample to be analyzed is a whole blood sample and only the following
Collect and handle the whole blood sample as follows:
1. Collect venous blood with a K
2. Rapidly and thoroughly mix the blood with the anticoagulant.
EDTA (1.5 to 2.2mg/mL ) anticoagulant collection tube;
2
z You should collect at least 2mL venous blood sample.
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 4 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℃ to 8℃) for 24 hours. You need to warm the
6-6
Operating Your Analyzer
refrigerated samples at room temperature for at least 30 minutes before
running them.
z Mix any sample that has been prepared for a while before running it.
6.6.2 Prediluted Samples
Collect and handle the prediluted sample as follows:
1. Press [MENU] and SELECT ”Count” to enter the ”Count” screen;
2. Press [MODE] to select prediluted analysis mode (any mode preceded by Prediluted);
3. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 6-1 shows;
Figure 6-1 A message box showing you how to dispense diluent
4. Present a clean sample tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 6-2 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 0.7mL of diluent (the dispensing volume is controlled by the analyzer)
into the tube;
Figure 6-2 How to dispense diluent
5. When the dispensing is finished, press [ENTER] to close the message box;
6. Add 20µL of capillary blood to the diluent and shake the tube to mix the sample.
6-7
Operating Your Analyzer
z Keep dust from the prepared diluent.
z When preparing a prediluted sample, only use lint-free tissue to wipe the
external wall of the capillary tube; do not use cotton balls.
z After mixing the capillary sample with the diluent, wait 5 minutes before
running the sample.
z Run the prediluted samples within 30 minutes after the mixing.
z Mix any sample that has been prepared for a while before running it.
z Evaluate predilute stability based on your laboratory’s sample population
and sample collection techniques or methods.
6-8
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