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BC-2800 Operation's Manual V10.0 Neutral
BC-2800 Operation's Manual V10.0 Neutral
BC-2800 Operation's Manual V10.0 Neutral
Operator’s Manual
Product name: Auto Hematology Analyzer
I
Table of Contents
1 Using This Manual ................................................................................... 1-1
1.1 Introduction ............................................................................................ 1-1
1.2 Who Should Read This Manual ............................................................. 1-2
1.3 How to Find Information......................................................................... 1-3
1.4 Conventions Used in This Manual ......................................................... 1-4
1.5 Special Terms Used in This Manual....................................................... 1-5
1.6 Symbols ................................................................................................. 1-6
1
Table of Contents
2
Table of Contents
3
Table of Contents
12 Appendices ..............................................................................................A-1
A Index .........................................................................................................A-1
B Specifications ..........................................................................................B-1
4
Table of Contents
D Communication .......................................................................................D-1
5
1 Using This Manual
1.1 Introduction
This chapter explains how to use your operator’s manual, which is shipped with your auto
hematology analyzer and contains reference information about the analyzer 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.
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
Using This Manual
This operator’s manual comprises 11 chapters and 4 appendices. Refer to the table below to
find the information you need.
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 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
This 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 may find the following symbols on the analyzer or the reagents.
BIOLOGICAL RISK
HIGH VOLTAGE
ALTERNATING CURRENT
USE BY
1-6
Using This Manual
SERIAL NUMBER
IN VITRO DIAGNOSTIC
DATE OF MANUFACTURE
TEMPERATURE LIMITATION
IRRITATING SUBSTANCE
1-7
Using This Manual
1-8
Using This Manual
(4)
(3)
(2)
(1)
(1)
Equipotentiality.
(2)
To avoid electric shock, disconnect power cord prior to removing or replacing fuse;
(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)
(5)
To avoid being injured, do not put hand under the motor when the machine is running.
1-10
Using This Manual
(6)
(6)
To avoid electrical shock, disconnect the power supply before maintaining this device.
1-11
Using This Manual
(7)
(7)
High Voltage
1-12
2 Understanding Your Analyzer
2.1 Introduction
2-1
Understanding Your Analyzer
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
histograms of blood samples.
Coefficient of Variation
Red Blood Cell (erythrocyte) Distribution Width RDW-SD
Standard Deviation
Hematocrit HCT
Platelet PLT
Mean Platelet Volume MPV
Platelet Distribution Width PDW
Plateletcrit PCT
2-2
Understanding Your Analyzer
2-3
Understanding Your Analyzer
2-4
Understanding Your Analyzer
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.
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.
2-6
Understanding Your Analyzer
Built-in keypad
The 18-key keypad is located below the LCD, as Figure 2-5 shows.
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.
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.
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.
2-8
Understanding Your Analyzer
Title Area
The Title area displays the title of the current screen, which, in case of Figure 2-6, is “Count”.
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”.
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.
2-9
Understanding Your Analyzer
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.
The Analysis Result area displays the analysis result, including histograms, of the current
sample.
The Error Message area displays error messages one by one, alternating every two
seconds.
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.
2-10
Understanding Your Analyzer
The system menu contains 7 programs. The programs followed by “>”s have further
sub-menus. See Figure 2-8 for the expanded menu.
2-11
Understanding Your Analyzer
2-12
Understanding Your Analyzer
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 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.
Store and use the reagents as directed by instructions for use of the
reagents.
When you have changed the diluent, rinse or lyse, run a background to see
if the results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Never use expired reagents.
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 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.
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.
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
us or our authorized distributors.
2-14
3 Understanding the System
Principles
3.1 Introduction
the impedance method for determining the WBC, 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
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 or 18μL 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
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.
3-4
Understanding the System Principles
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.
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
WBC (109/ L) is the number of leukocytes measured directly by counting the white blood cells
passing through the aperture.
WBC n 109 / L
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,
100
WBC'=WBC
100+NRBC
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.
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.
PL
Lymph% 100
PL PM PG
PM
Mid% 100
PL PM PG
PG
Gran% 100
PL PM PG
9
where PL = particles in the lymphocyte region( 10 / L )
9
PM = particles in the mid size region( 10 / L )
9
PG = particles in the granulocyte region( 10 / L ).
Having achieved the three parameters above, this analyzer proceeds to calculate the
9
Lymph# , Mid# and Gran# per the following equations and express them in 10 / L .
3-6
Understanding the System Principles
Lymph% WBC
Lymph#
100
Mid % WBC
Mid #
100
Gran % WBC
Gran #
100
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.
3.4.4 HGB
Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L) as
follows.
3-7
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, 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 5.3 for 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.
3-8
Understanding the System Principles
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.
RBC
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.
MCV
Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
3-9
Understanding the System Principles
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 3-5 shows.
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
PLT
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
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
3-12
4 Installing Your Analyzer
4.1 Introduction
This chapter introduces how to install the analyzer. To ensure all system components function
correctly and to verify system performance, our authorized representatives will handle the
installation and initial software setup.
4-1
Installing Your Analyzer
Before installation, you should ensure that the following space, power and environmental
requirements are met.
enough room on or below the countertop to accommodate the diluent, rinse and waste
containers.
Voltage: (100V-240V~)±10%;
Frequency: 50/60±1 Hz
Power: 180VA
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
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.
4-3
Installing Your Analyzer
4.3 Unpacking
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 our customer device 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 our
customer device 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.
Retain the shipping carton and all the packing materials, as they can be
used for packaging if analyzer must be reshipped.
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
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
After installing new reagents, keep the reagents still for a while before using
them.
4-5
Installing Your Analyzer
(Figure 4-1);
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;
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.
4-6
Installing Your Analyzer
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;
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.
4-7
Installing Your Analyzer
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.
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;
4-8
Installing Your Analyzer
Remove the protective paper between the recorder head and the roller
inside the recorder before installing recorder paper.
1. Use the latch at the upper right corner of the recorder door to pull the door open.
4. Check if paper is installed correctly and the paper end is feeding from the top.
Paper roll
Use 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.
Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.
Do not leave the recorder door open unless you install paper or remove
trouble.
Improper installation of recorder paper may jam the paper and/or result in
blank printout.
4-9
Installing Your Analyzer
4-10
Installing Your 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 analyzer 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
Chapters 5.2 to 5.3.
5-1
Customizing the Analyzer Software
5.2 Password
The analyzer 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.
SELECT “Setup → Password” ( Figure 5-1 ) to enter the ”Password” screen ( Figure 5-2 ).
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
CLICK “Yes” to confirm the password and exit to the system menu.
CLICK “Yes” to confirm the password and exit to the system menu.
5-3
Customizing the Analyzer Software
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.
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 ⊙.
You can change the settings of the items displayed in this area.
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.
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.
2. ENTER the desired digits. See Table 5-1 for the valid reagent volumes.
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
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.
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.
When you have finished changing all the desired reagent settings, you may
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.
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.
5-6
Customizing the Analyzer Software
To select a printing device, SELECT “Recorder” or “Printer” from the “Device” drop-down
list, as Figure 5-10 shows.
If you have selected the printer, you can choose any of the following 4 printing formats.
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.
5-7
Customizing the Analyzer Software
To choose the desired format, SELECT the desired format from the “Format” pull-down list,
as Figure 5-11 shows.
Auto printing
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.
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
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.
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.
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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.
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
Figure 5-16 shows.
1. SELECT “Recorder” or ”Printer” in the “Report Title” field, depending on the selected
5-10
Customizing the Analyzer Software
printing device;
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.
5-11
Customizing the Analyzer Software
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.
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.
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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.
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.
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.
5-13
Customizing the Analyzer Software
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.
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
ExpectedMCV 90.0
100%= 100% 109.8%
ActualMCV 82.0
You should adjust the RBC gain to 109.8% as close as possible. Follow the steps given below
to do so.
4. ENTER the desired gain so that the adjustment becomes as close to 109.8% as possible.
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.
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
Customizing the Analyzer Software
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.
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
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.
5-17
Customizing the Analyzer Software
*** 104/uL /
*.** /pL /
HCT **.* % Default
.*** L/L /
MCV, RDW-SD ***.* fL Default
***.* um3 /
***.* um3 /
PDW **.* / Default
PCT .*** % Default
*.** mL/L /
MCH *.*** pg Default
**.** fmol /
3. SELECT the desired unit from the drop-down list of the desired parameter, as Figure
5-30 shows.
5-18
Customizing the Analyzer Software
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.
5-19
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.
The upper and lower limits of the reference ranges are visible to all users but changeable
5-20
Customizing the Analyzer Software
only to administrators, as Figure 5-33 shows. Follow the instructions below to set the ranges.
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.
5-21
Customizing the Analyzer Software
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;
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;
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
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;
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 Your Analyzer for
detail.
2. At the “Settings” screen, press [F1] to select the “Auto Maintain” group, as Figure 5-39
shows.
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.
5-24
Customizing the Analyzer Software
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.
5-25
Customizing the Analyzer Software
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.
5-26
Customizing the Analyzer Software
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.
3. SELECT “Black” (default) or “Blue” from the “PMB color” drop-down list, as Figure
5-44 shows.
You can delete the information in the list of “Dept.”, “Sender”, “Tester” and “Checker” stored
in the edit window when input patient information.
5-27
Customizing the Analyzer Software
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.
Follow the steps given below to enable or disable the function of resetting sample ID after
startup. If you SELECT “On” from the “Reset sample ID after startup” pull-down list, the
default ID of the next sample will be reset to 1 after you restart the analyzer, and other sample
information will be empty; if you SELECT “Off” from the “Reset sample ID after startup”
pull-down list, the ID and other information of the next sample will remain the same after you
restart the analyzer.
3. SELECT “On” (default) or “Off” from the “Reset sample ID after startup” pull-down list,
as Figure 5-46 shows.
5-28
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 5-47 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.
5-29
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
No
Whole Blood Mode? Run Prediluted Samples
Yes
Shutdown
6-1
Operating Your Analyzer
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.
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.
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.
Running samples with the abnormal background error present will lead to
unreliable results.
6-3
Operating Your Analyzer
Before running any samples, run the controls. See Chapter 8 Using the QC Programs for
details.
6-4
Operating Your Analyzer
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
parameters are analyzed: RBC, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV,
PDW and PCT, plus the RBC and PLT histograms.
4. Prediluted - All
It means the sample to be analyzed is a prediluted blood sample and all the 19 parameters
are to be analyzed, plus 3 histograms.
5. Prediluted - 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.
6. Prediluted -RBC/PLT
It means the sample to be analyzed is a prediluted blood sample and only the following
parameters are analyzed: RBC, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV,
PDW and PCT, plus the RBC and PLT histograms.
6-5
Operating Your Analyzer
1. Collect venous blood with a K2EDTA (1.5 to 2.2mg/mL ) anticoagulant collection tube;
6-6
Operating Your Analyzer
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.
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
refrigerated samples at room temperature for at least 30 minutes before
running them.
Mix any sample that has been prepared for a while before running it.
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;
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;
6-7
Operating Your Analyzer
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.
When preparing a prediluted sample, only use lint-free tissue to wipe the
external wall of the capillary tube; do not use cotton balls.
After mixing the capillary sample with the diluent, wait 5 minutes before
running the sample.
Mix any sample that has been prepared for a while before running it.
6-8
Operating Your Analyzer
Press [MENU] and SELECT ”Count” to enter the ”Count” screen, as Figure 6-3 shows.
Press [MODE] to select whole blood mode (any mode preceded by Whole blood);
When you save the next sample information, run sample analysis;
Otherwise, the input sample information cannot be displayed when
restarting the analyzer.
ID only
All Info
ID only mode
To enter the sample ID of the next sample, you may
6-9
Operating Your Analyzer
At the “Count” screen, use the bar-code scanner (if available) to scan the sample ID into the
analyzer; or
At the “Count” screen, press [F1] to enter the “ID” window and ENTER the sample ID.
When you have finished entering the sample ID, you may press [MENU] and a dialog box will
pop up, as Figure 6-5 shows. To ignore the entered number, CLICK “No”; otherwise, CLICK
“Yes”.
6-10
Operating Your Analyzer
At the “Count” screen, press [F1] and an edit window will pop up, as Figure 6-6 shows.
Entering sample ID
ENTER the ID number in the “ID” box, or if you have the bar-code scanner installed, you can
simply scan the sample ID into the analyzer.
SELECT the desired item from the “Gender” drop-down list, as Figure 6-7 shows. Note
that you can select blank in case you are not aware of the patient gender.
6-11
Operating Your Analyzer
This analyzer provides three ways for you to enter the patient age –in years, in months and in
days.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the “Years” box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the “Months” box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
“Days” box.
ENTER the number of the patient’s medical chart into the “Chart No.” box.
ENTER the number of the patient’s bed into the ”Bed No.“ box.
You can either directly ENTER the name of the department, from which the sample came,
into the “Department” box or SELECT the desired department from the “Department”
pull-down list (if there are previously saved departments in the list, as Figure 6-8 shows).
6-12
Operating Your Analyzer
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, 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) ; to enter the name of
the person who is to review the sample results, enter the name into the “Reviewer” box, or
SELECT the desired name from the “Checker” pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
Exit edit
When you have finished entering all the desired sample information, CLICK the “Yes” button
to save the changes and return to the “Count” screen. If you do not want to save the entered
information, CLICK the “No” button to return to the ”Count” screen without saving the
changes.
Entering Edit
At the “Count” screen, press [F4] and an edit window will pop up, as Figure 6-9 shows.
Follow the instructions to enter the information of the first sample.
6-13
Operating Your Analyzer
Save
Next/Prev
If you want to review the entered information of a specific sample, press the appropriate
arrow keys to CLICK “Prev.” or “Next” to review the previous or next sample until the desired
sample is reached.
Delete
If you want to delete the currently displayed sample information, CLICK “Delete” to complete
the deletion.
Exit
When you are done with the batch, CLICK “Exit” to exit to the “Count” screen. After a sample
is analyzed, its corresponding sample information will be automatically displayed in the
Current sample area.
6-14
Operating Your Analyzer
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
1. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display “Running” and the analyzer
will start aspirating sample;
2. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
3. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be repositioned. And if the
auto print function is enabled, the analysis result will be automatically printed out;
6-15
Operating Your Analyzer
If you don’t want to re-count this sample, CLICK “No”; otherwise, CLICK “Yes” to enter the
“Re-count” screen, as Figure 6-11 shows. This “Re-count” screen is similar to the “Count”
screen, except the lower sub-area of the Sample Information area is tiled “Re-count” as
opposed to “Next sample”. The sample ID remains unchanged.
Follow the previously introduced procedure to re-analyze the sample in question. The new
6-16
Operating Your Analyzer
result will overwrite the old result while the sample information keeps unchanged.
Parameter flags
If the analysis result is followed by an ”H” or “L”, it means the analysis result has
exceeded the upper or lower limit of the reference range.
If you see *** as opposed to the result, it means the result is either unreliable or out of the
operating range.
If the WBC result is less than 0.5 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).
Histogram flags
The system will flag abnormal histograms.
Abnormal WBC histograms will be flagged by one of the markings: R1, R2, R3, R4 and
Rm.
R1: indicates abnormality on the left side of the lymphocyte hump and possible presence of
platelet clumps, giant platelets, nucleated red cell, insolvable red cell, protein and lipoid
debris in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mid-sized cell area and
possible presence of abnormal lymphocyte, plasma cell, atypical lymphocyte, original
granulocytes in the sample and eosinophilia or basophilia.
R3: indicates abnormality between the mid-sized cell area and the granulocytes and possible
presence of immature granulocytes, abnormal sub-population in the sample, or eosinophilia.
R4: indicates abnormality on the right side of the granulocytes hump and netrophilia.
Rm: indicates at least two R flags.
Abnormal PLT histograms will be flagged by one of the markings: Pm, PS and PL.
Pm: indicates blur demarcation between the platelet and red blood cell area and possible
presence of large platelet, platelet coagulation, small red blood cell, cell debris or fibrin.
PS: indicates excessive small PLTs.
PL: indicates excessive large PLTs.
6-17
Operating Your Analyzer
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
6-18
Operating Your Analyzer
Press [MENU] and SELECT ”Count” to enter the ”Count” screen, as Figure 6-12 shows.
ID only
All Info
ID only
To enter the sample ID of the next sample, you may
At the “Count” screen, use the bar-code scanner (if available) to scan the sample ID into the
analyzer; or
At the “Count” screen, press [F1] to enter the “ID” window and ENTER the sample ID.
6-19
Operating Your Analyzer
When you have finished entering the sample ID, you may press [MENU] and a dialog box will
pop up, as Figure 6-14 shows. To ignore the entered number, CLICK “No”; otherwise, CLICK
“Yes”.
6-20
Operating Your Analyzer
At the “Count” screen, press [F1] and an edit window will pop up, as Figure 6-15 shows.
Entering sample ID
ENTER the ID number in the “ID” box, or if you have the bar-code scanner installed, you can
simply scan the sample ID into the analyzer.
SELECT the desired item from the “Gender” drop-down list, as Figure 6-16 shows. Note
that you can select blank in case you are not aware of the patient gender.
6-21
Operating Your Analyzer
This analyzer provides three ways for you to enter the patient age –in years, in months and in
days.
To enter the patient’s age in years: ENTER the desired number, an integer from 0 to 200, into
the “Years” box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the “Months” box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
“Days” box.
ENTER the number of the patient’s medical chart into the “Chart No.” box.
ENTER the number of the patient’s bed into the ”Bed No.“ box.
You can either directly ENTER the name of the department, 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, as Figure 6-17 shows).
6-22
Operating Your Analyzer
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, 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) ; to enter the name of
the person who is to review the sample results, enter the name into the “Reviewer” box, or
SELECT the desired name from the “Checker” pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
Exit edit
When you have finished entering all the desired sample information, CLICK the “Yes” button
to save the changes and return to the “Count” screen. If you do not want to save the entered
information, CLICK the “No” button to return to the ”Count” screen without saving the
changes.
Entering Edit
At the “Count” screen, press [F4] and an edit window will pop up, as Figure 6-21 shows.
Follow the instructions to enter the information of the first sample.
6-23
Operating Your Analyzer
Save
Next/Prev
If you want to review the entered information of a specific sample, press the appropriate
arrow keys to CLICK “Prev.” or “Next” to review the previous or next sample until the desired
sample is reached.
Delete
If you want to delete the currently displayed sample information, CLICK “Delete” to complete
the deletion.
Exit
When you are done with the batch, CLICK “Exit” to exit to the “Count” screen. After a sample
is analyzed, its corresponding sample information will be automatically displayed in the
Current sample area.
6-24
Operating Your Analyzer
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
1. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display “Running” and the analyzer
will start aspirating sample;
2. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
3. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be repositioned. And if the
auto print function is enabled, the analysis result will be automatically printed out;
6-25
Operating Your Analyzer
If you don’t want to re-count this sample, CLICK “No”; otherwise, CLICK “Yes” to enter the
“Re-count” screen. This “Re-count” screen is similar to the “Count” screen, except the lower
sub-area of the Sample Information area is tiled “Re-count” as opposed to “Next sample”.
The sample ID remains unchanged.
Follow the previously introduced procedure to re-analyze the sample in question. The new
result will overwrite the old result while the sample information keeps unchanged.
Parameter flags
If the analysis result is followed by an ”H” or “L”, it means the analysis result has
exceeded the upper or lower limit of the reference range.
If you see *** as opposed to the result, it means the result is either unreliable or out of the
operating range.
If the WBC result is less than 0.5 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).
Histogram flags
The system will flag abnormal histograms.
Abnormal WBC histograms will be flagged by one of the markings: R1, R2, R3, R4 and
Rm.
R1: indicates abnormality on the left side of the lymphocyte hump and possible presence of
platelet clumps, giant platelets, nucleated red cell, insolvable red cell, protein and lipoid
debris in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mid-sized cell area and
possible presence of abnormal lymphocyte, plasma cell, atypical lymphocyte, original
granulocytes in the sample and eosinophilia or basophilia.
R3: indicates abnormality between the mid-sized cell area and the granulocytes and possible
presence of immature granulocytes, abnormal sub-population in the sample, or eosinophilia.
R4: indicates abnormality on the right side of the granulocytes hump and netrophilia.
Rm: indicates at least two R flags.
Abnormal PLT histograms will be flagged by one of the markings: Pm, PS and PL.
6-26
Operating Your Analyzer
Pm: indicates blur demarcation between the platelet and red blood cell area and possible
presence of large platelet, platelet coagulation, small red blood cell, cell debris or fibrin.
PS: indicates excessive small PLTs.
PL: indicates excessive large PLTs.
When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.
6-27
Operating Your Analyzer
6.9 Shutdown
1. Press [MENU] to enter the system menu and SELECT ”Shutdown”, as Figure 6-20
shows;
2. A message box will pop up to ask you to confirm the shutdown, as Figure 6-21 shows;
3. CLICK “Yes” and a window will pop up to instruct you how to shut down the analyzer, as
Figure 6-22 shows;
6-28
Operating Your Analyzer
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
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.
4. Present the E-Z cleanser to the sample probe and press the aspirate key. The analyzer
will aspirate the E-Z cleanser and automatically clean the fluidic lines and the bath. The
cleaning progress will be displayed on the screen, as Figure 6-23 shows;
5. When the cleaning is finished, place the switch at the back of the analyzer to OFF (O) to
turn off the analyzer;
6-29
Operating Your Analyzer
6-30
7 Reviewing Sample Results
7.1 Introduction
The analyzer automatically saves analysis results. Totally 20,000 results can be saved. You
can either browse all the saved sample results in general or search for the results of a
particular sample or samples.
7-1
Reviewing Sample Results
To browse all the saved sample results, you can choose either of the following modes:
In this mode, you can review both parameter values and histograms of the saved sample
results, one sample result per screen.
In this mode, the sample results are presented in a columnar fashion without histograms
(namely you can only see the parameter values). One screen displays a maximum of 8
sample results.
7-2
Reviewing Sample Results
ENTER the location into the “Location” box and press [ENTER] to jump to the desired
sample result.
7-3
Reviewing Sample Results
ID
Selecting gender
SELECT the desired item from the “Gender” drop-down list. Note that you can select blank
in case you are not aware of the patient gender.
This analyzer provides three ways for you to enter the patient age – in years, in months and
in days. The first way is designed for the patients no younger than one year; the second for
the patients older than one month and younger than one year; the third for the patients
younger than one month. You can choose only one of the three ways to enter the patient age.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the “Years” box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the “Months” box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
“Days” box.
ENTER the number of the patient’s medical chart into the “Chart No.” box.
7-4
Reviewing Sample Results
ENTER the number of the patient’s bed into the ”Bed No.“ box.
You can either directly ENTER the name of the department, 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).
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, 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) ; to enter the name of
the person who is to review the sample results, enter the name into the “Reviewer” box, or
SELECT the desired name from the “Checker” pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
“Yes” button
When you have finished entering all the desired sample information, CLICK the “Yes” button
to save the changes and return to exit the edit window.
“No” button
If you do not want to save the entered information, CLICK the “No” button to return to exit the
edit window.
Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually after you
have entered the administrator password.
The first three discriminators of the WBC histogram are adjustable. Note that if the WBC
result is less than 0.5 or non-numeric (***), the WBC histogram is not adjustable.
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.
For example, to move the third discriminator of the following WBC histogram, follow the
procedure below to do so.
7-5
Reviewing Sample Results
1. Press [ENTER] and the discriminator will become adjustable. See Figure 7-5;
2. Press [↑] or [↓] as needed to select the WBC histogram, as Figure 7-6 shows;
7-6
Reviewing Sample Results
5. Press [ENTER] and a message box will pop up, as Figure 7-9 shows.
6. CLICK “Yes” to save the changes and return to the “Review” screen.
The sample results are sequentially displayed on the screen, The “Loc/Total” displayed in the
7-7
Reviewing Sample Results
lower right corner of the screen indicates the location of the current sample result (the one
whose “ID” is backlit) and the total number of the sample results.
ENTER the location into the “Location” box and press [ENTER] to jump to the desired
sample result.
Press [←] or [→] to move the cursor to the desired sample result and press [ENTER] to select
it. The selected sample result will be marked with a “*”, as sample “117” in Figure 7-12 shows.
7-8
Reviewing Sample Results
Press [ENTER] again to deselect the sample result. Once the sample is deselected, the “*”
will disappear, as Figure 7-13 shows.
Example1: To select the sample results of locations 1 to 5 (sample IDs:114 to 118 ), follow the
procedure below to do so:
7-9
Reviewing Sample Results
4. CLICK “Select” and the lower left corner of the “Select” window will display “Select
samples”, as Figure 7-15 shows;
5. CLICK “Exit” to return to the sample table review screen. The selected sample results
will be marked with “*”, as Figure 7-16 shows.
Example2: To deselect the sample results of locations 1 to 5, follow the procedure below to
do so:
2. CLICK “De-select” and the lower left corner of the “Select” window will display
7-10
Reviewing Sample Results
3. CLICK “Exit” to return to the sample table review screen. The “*” above those sample
results will disappear, as Figure 7-18 shows.
Example3: To select the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
3. CLICK “Exit” to return to the sample table review screen. The selected sample results
will be marked with “*”, as Figure 7-19 shows.
7-11
Reviewing Sample Results
Example4: To deselect the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
3. CLICK “Quit” to return to the sample table review screen. The “*” above those sample
results will disappear, as Figure 7-20 shows.
7-12
Reviewing Sample Results
Special functions
To access the “Special Functions” screen, you must first select several (1 to 500) sample
results and then press [F5] to enter the “Special Functions” screen, as Figure 7-23 shows.
7-13
Reviewing Sample Results
Two special functions are included in “Special Functions” screen – “Reprodu.” and “Trend”.
The former is open to all users, as Figure 7-23 shows, while the latter to administrators only,
as Figure 7-24 shows.
Reproducibility
See Figure 7-23 for the “Special Functions” screen open to all users. The screen consists of
two fields, the left displaying the available functions and the right displaying the 19
parameters and their reproducibility indices (“Mean”, “Diff” and “CV”).
If the selected samples are less than 3, the reproducibility indices are all 0. If the analysis
result of certain parameter is invalid (***), the corresponding index will also be invalid (***).
7-14
Reviewing Sample Results
Trend
After entering the administrator password, you can enter the “Special Functions” screen
open to administrators, as Figure 7-24 shows. Press [F1] to access the “Trend”, which
displays the WBC, RBC, PLT, HGB, MCV and RDW-CV trends of the selected sample results.
The six trends are displayed in two screens, three trends in one, as Figure 7-25 and Figure
7-26 show. You can press [↑][↓] to switch between the screens. The selected results are
sequentially presented in the trend, newest at the utmost left (No. 1).
At either screen, you can press [←] or [→] to view the results (displayed below the parameter
box) of every point presented in the graph. The current cursor position is displayed to the
right of “No.” and the time at which the sample was analyzed is displayed to the right of
“Time”. You can also press [PgUp] or [PgDn] to jump forward or backward by 20 samples.
7-15
Reviewing Sample Results
The x-coordinate represents how many sample results have been selected. The
y-coordinate represents the analysis results of the displayed parameters.
For every parameter, the upper dash line of its trend represents the upper limit of the
expected range, 10% above the mean, of the analysis result. In case of WBC in Figure
7-25, the upper limit is “10.2”.
For every parameter, the lower dash line of its trend represents the lower limit of the
expected range, 10% below the mean, of the analysis result. In case of WBC in Figure
7-25, the lower limit is “8.4”.
For every parameter, its mean is displayed between the values of the upper dash line
and of the lower dash line. In case of WBC in Figure 7-25, the mean is “9.3”.
For every parameter, the three numbers on the right of its trend represents:
“Mean” – the mean value of the saved results
“Diff” – standard deviation of the saved analysis results
“CV” - Coefficient of Variation
X
i 1
i
Mean
n
Diff
X i Mean 2
n 1
Diff
CV 100%
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis. If the selected samples are less than 3, the three indices will all be 0. If the analysis
result of certain parameter is invalid (***), the three indices will also be invalid (***). Under
these two circumstances, the three values on the left of the trends are the parameter’s means
and expected ranges set by the user (see Chapter 5.3.6).
7-16
Reviewing Sample Results
To include a search condition, press [↑] or [↓] to move the cursor to the desired condition and
press [ENTER] to select the condition, as Figure 7-28 shows.
7-17
Reviewing Sample Results
SELECT the desired item from the “Gender” drop-down list. Note that you can select blank
in case you are not aware of the patient gender.
You can either directly ENTER the name of the department, 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,
Entering sample ID
ENTER the number of the patient’s bed into the ”Bed No.“ box.
ENTER the number of the patient’s medical chart into the “Chart No.” box.
ENTER the start date into the “Start” box; ENTER the end date into the “End” box.
CLICK “Yes” to start the search. The analyzer will search the saved sample results for
matches and report the conclusion at “Search Result” window, as Figure 7-29 shows. CLICK
“Yes” of the “Search Result” window to return to the searched sample review screen,. The
matches found are saved in a database called “Searched” and you can review them in either
the “Table” mode or the “Histogram” mode.
7-18
Reviewing Sample Results
For every search, the analyzer can display a maximum of 500 matches.
The matches will be deleted if you have run another sample (including
background check), or deleted a sample result, or restarted the analyzer
after the search.
7-19
Reviewing Sample Results
The sample results are sequentially displayed on the screen, The “Loc/Total” displayed in the
lower right corner of the screen indicates the location of the current sample result (the one
whose “ID” is backlit) and the total number of the sample results matching the search
conditions.
7-20
Reviewing Sample Results
ENTER the location into the “Location” box and press [ENTER] to jump to the desired
sample result.
Press [←] or [→] to move the cursor to the desired sample result and press [ENTER] to select
it. The selected sample result will be marked with a “*”, as sample “118” in Figure 7-32 shows.
Press [ENTER] again to deselect the sample result. Once the sample is deselected, the “*”
will disappear, as Figure 7-33 shows.
7-21
Reviewing Sample Results
Example1: To select the sample results of locations 1 to 5 (sample IDs:114 to118 ), follow the
procedure below to do so:
4. CLICK “Select” and the lower left corner of the “Select” window will display “Select
samples”, as Figure 7-35 shows;
7-22
Reviewing Sample Results
5. CLICK “Exit” to return to the sample table review screen. The selected sample results
will be marked with “*”, as Figure 7-36 shows.
Example2: To deselect the sample results of locations 1 to 5, follow the procedure below to
do so:
2. CLICK “De-select” and the lower left corner of the “Select” window will display
“De-select the result”, as Figure 7-37 shows;
3. CLICK “Exit” to return to the sample table review screen. The “*” above those sample
results will disappear, as Figure 7-38 shows.
7-23
Reviewing Sample Results
Example3: To select the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
3. CLICK “Exit” to return to the sample table review screen. The selected sample results
will be marked with “*”, as Figure 7-39 shows.
Example4: To deselect the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
7-24
Reviewing Sample Results
3. CLICK “Exit” to return to the sample table review screen. The “*” above those sample
results will disappear, as Figure 7-40 shows.
7-25
Reviewing Sample Results
Special functions
To access the “Special Functions” screen, you must first select several (1 to 500) sample
results and then press [F5] to enter the “Special Functions” screen, as Figure 7-43 shows.
Two special functions are included in this screen – “Reprodu.” and “Trend”. The former is
open to all users, as Figure 7-43 shows, while the latter to administrators only, as Figure 7-44
shows.
7-26
Reviewing Sample Results
Reproducibility
See Figure 7-43 for the “Special Functions” screen open to all users. The screen consists of
two fields, the left displaying the available functions and the right displaying the 19
parameters and their reproducibility indices (“Mean”, “Diff” and “CV”).
If the selected samples are less than 3, the reproducibility indices are all 0. If the analysis
result of certain parameter is invalid (***), the corresponding index will also be invalid (***).
Trend
After entering the administrator password, you can enter the “Special Functions” screen
open to administrators, as Figure 7-44 shows. Press [F1] to access the “Trend”, which
displays the WBC, RBC, PLT, HGB, MCV and RDW-CV trends of the selected sample results.
The six trends are displayed in two screens, three trends in one, as Figure 7-45 and Figure
7-46 show. You can press [↑][↓] to switch between the screens. The selected results are
sequentially presented in the trend, newest at the utmost left (No. 1).
7-27
Reviewing Sample Results
At either screen, you can press [←] or [→] to view the results (displayed below the parameter
box) of every point presented in the graph. The current cursor position is displayed to the
right of “No.” and the time at which the sample was analyzed is displayed to the right of
“Time”. You can also press [PgUp] or [PgDn] to jump forward or backward by 20 samples.
The x-coordinate represents how many sample results have been selected. The
y-coordinate represents the analysis results of the displayed parameters.
For every parameter, the upper dash line of its trend represents the upper limit of the
expected range, 10% above the mean, of the analysis result. In case of WBC in Figure
7-45, the upper limit is “10.2”.
7-28
Reviewing Sample Results
For every parameter, the lower dash line of its trend represents the lower limit of the
expected range, 10% below the mean, of the analysis result. In case of WBC in Figure
7-45 , the lower limit is “8.4”.
For every parameter, its mean is displayed between the values of the upper dash line
and of the lower dash line. In case of WBC in Figure 7-45, the mean is “9.3”.
For every parameter, the three numbers on the right of its trend represents:
“Mean” – the mean value of the saved results
“Diff” – standard deviation of the saved analysis results
“CV” - Coefficient of Variation
X
i 1
i
Mean
n
Diff
X i Mean 2
n 1
Diff
CV 100%
Mean
where n represents how many sample results are selected and Xi is the result of the ith
analysis. If the selected samples are less than 3, the three indices will all be 0. If the analysis
result of certain parameter is invalid (***), the three indices will also be invalid (***). Under
these two circumstances, the three values on the left of the trends are the parameter’s means
and expected ranges set by the user (see Chapter 5.3.6).
7-29
Reviewing Sample Results
7-30
Reviewing Sample Results
ENTER the location into the “Location” box and press [ENTER] to jump to the desired
sample result.
ID
Selecting gender
SELECT the desired item from the “Gender” drop-down list. Note that you can select blank
in case you are not aware of the patient gender.
This analyzer provides three ways for you to enter the patient age – in years, in months and
in days. The first way is designed for the patients no younger than one year; the second for
the patients older than one month and younger than one year; the third for the patients
younger than one month. You can choose only one of the three ways to enter the patient age.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the “Years” box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the “Months” box.
7-31
Reviewing Sample Results
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
“Days” box.
ENTER the number of the patient’s medical chart into the “Chart No.” box.
ENTER the number of the patient’s bed into the ”Bed No.“ box.
You can either directly ENTER the name of the department, 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).
To enter the name of the person who sent the sample for analysis, enter the name into the
“Sender” box or SELECT the desired name from the “Sender” pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, 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) ; to enter the name of
the person who is to review the sample results, enter the name into the “Reviewer” box, or
SELECT the desired name from the “Checker” pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.
“Yes” button
When you have finished entering all the desired sample information, CLICK the “Yes” button
to save the changes and return to exit the edit window.
“No” button
If you do not want to save the entered information, CLICK the “No” button to return to exit the
edit window.
Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually after you
have entered the administrator password.
The first three discriminators of the WBC histogram are adjustable. Note that if the WBC
result is less than 0.5 or non-numeric (***), the WBC histogram is not adjustable.
The first two discriminators of the RBC histogram are adjustable. Note that if the RBC result
7-32
Reviewing Sample Results
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.
For example, to move the third discriminator of the following WBC histogram, follow the
procedure below to do so.
1. Press [ENTER] and the discriminator will become adjustable. See Figure 7-50;
2. Press [↑] or [↓] as needed to select the WBC histogram, as Figure 7-51 shows;
7-33
Reviewing Sample Results
5. Press [ENTER] and a message box will pop up, as Figure 7-54 shows.
CLICK “Yes” to save the changes and return to the “Review” screen.
7-34
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.
We recommend you run the QC program daily. 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 files. 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.
This analyzer provides two QC programs – QC with controls and X-B analysis.
Use the specified controls. Using controls other than the specified will lead
to misleading results.
Refer to the instructions of use of the controls for how to store and use the
controls.
8-1
Using the QC Programs
Selecting a QC file
The analyzer provides 9 QC files for you to save QC settings and results. Every QC file can
save the results of a maximum of 31 QC runs. When the saved QC results have reached the
maximum number, the newest result will overwrite the oldest. You can press [F1] to switch the
QC files and the number will be given on the upper left of the screen. After selecting the QC
file, press [F2] to select the “Whole Blood” or “Prediluted” mode.
8-2
Using the QC Programs
Editing QC settings
If there are saved QC results and settings, you need to delete them first. You can press [F5]
to enter “QC Table” screen to delete all the results, see Chapter 8.2.3 for details.
Press [F3] at “Controls” screen to enter the “QC Edit” screen (Figure 8-3).
ENTER the lot number of the control to be used into the “Lot No.” box, as Figure 8-4 shows.
ENTER the expiration date of the control to be used into the “Exp. Date” box, as Figure 8-5
8-3
Using the QC Programs
shows.
ENTER the expected results (mean) and limits (range) respectively into the “Mean” and
“Range” boxes of the parameters to be included in the QC analysis, as Figure 8-6 shows.
8-4
Using the QC Programs
Refer to the instructions of use of the control for information on the lot
number, expiration date, open-vial stability days, expected results and limits.
The entered expiration date should be either the expiration date printed on
the labeling or the open-vial expiration date. It is earlier.
The open-vial expiration date is calculated as follows: the date that vial is
opened + the open-vial stability days.
At the “QC Edit” screen, if you want to correct an erroneous entry, MODIFY
the wrong digit.
Deleting settings
Printing settings
Press [MENU] to exit to the system menu. A message box shown in Figure 8-7 will pop up, if:
1. There is a parameter for which you have entered only the expected result or the limit; or
2. There is a parameter whose expected result is less than or equal to the limit.
CLICK “Yes” to close the box and clear the erroneous entries. Re-enter the correct values
before trying to exit the screen again. The settings can be saved only when both the expected
result and limit are valid.
If all the entries are correct, a message box will pop up to remind you to save the changes, as
Figure 8-8 shows. CLICK “Yes” to save the changes and exit to the “Controls” screen;
CLICK “No” to abort the changes and exit to the “Controls” screen.
8-5
Using the QC Programs
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
Keep the sample probe tip away from the tube bottom; otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
8-6
Using the QC Programs
3. Present a vial of control to the sample probe so that the tip is well into the vial, and press
the aspirate key. The System Status area will display “Running” and the analyzer will
start aspirating sample;
4. When you hear a beep and the sample probe is out of the vial, remove the vial. The
sample probe will retract into the analyzer and the analysis progress will be displayed on
the screen;
5. When the analysis is finished, the result will be displayed on the screen and the
“NO./Total” in the upper left corner of the screen will automatically increase by 1 and the
sample probe will be repositioned.
To delete the current result, press [DEL] and a message box will pop up, as Figure 8-9 shows.
CLCIK “Yes” to confirm the deletion.
Printing QC results
8-7
Using the QC Programs
Prediluted Mode
3. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 8-10 shows;
4. Present a clean sample tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 8-11 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 0.7ml of diluent (the dispensing volume is controlled by the analyzer) into
the tube;
5. When the dispensing is finished, press [ENTER] to close the message box;
6. Add 20μL of control to the diluent and shake the tube to mix the sample;
7. Present the mixed control to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display “Running” and the analyzer
will start aspirating sample;
8. When you hear the beep and the sample probe is out of the tube, remove the sample
8-8
Using the QC Programs
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
9. When the analysis is finished, the result will be displayed on the screen and the
“NO./Total” in the upper left corner of the screen will automatically increase by 1 and the
sample probe will be repositioned.
To delete the current result, press [DEL] and a message box will pop up, as Figure 8-12
shows. CLICK “Yes” to confirm the deletion.
Printing QC results
You can review the saved results in either of the two modes – “L-J Graph” and “QC Table”.
8-9
Using the QC Programs
L-J Graph
At the “Controls” screen, press [F4] to enter the” L-J Graph” screen, as Figure 8-13, Figure
8-14 and Figure 8-15 shows.
8-10
Using the QC Programs
The 12 parameters are divided into 3 groups for display, one group for one screen. You can
press [↑] or [↓] to switch among the screens. At every” L-J Graph” screen, you can press [←]
or [→] to view the results (displayed below the parameter box) of every point presented in the
graph. The current cursor position is displayed to the right of “No.” field and the time at which
this QC run was done is displayed to the right of ”Time” field.
The x-coordinate represents how many times the QC program has been run. The
y-coordinate represents the analysis results of the displayed parameters.
For every parameter, the upper dash line of its L-J graph represents the upper limit of the
expected range of the analysis result. The corresponding value (4.9 in case of the WBC
in Figure 8-13) equals Mean + Range and is displayed to the left of the line.
For every parameter, the lower dash line of its L-J graph represents the lower limit of the
expected range of the analysis result. The corresponding value (4.1 in case of the WBC
in Figure 8-13) equals Mean - Range is displayed to the left of the line.
For every parameter, its expected result (4.5 in case of the WBC in Figure 8-13) is
displayed between the values of the upper dash line and of the lower dash line.
For every parameter, the three numbers displayed to the right of its L-J graph represents:
“Mean” – the mean value of the saved results, as the equation below defines,
n
X i
Mean i 1
n
where n represents how many times the QC program has been run and Xi is the result
acquired from every QC analysis.
8-11
Using the QC Programs
“Diff” – standard deviation of the saved analysis results, as the equation below defines,
Diff
X i Mean 2
n 1
where n represents how many times the QC program has been run and Xi is the result
acquired from every QC analysis and “Mean” is the mean value derived from the first
equation.
“CV” – Coefficient of Variation, as the equation below defines
Diff
CV 100%
Mean
where Mean is the mean value derived from the first equation and Diff is the standard
deviation derived from the second equation.
The darkened square ■ that falls between the upper and the lower dash lines is within the
control range. Otherwise, it is not. The blank square □ represents the QC analysis either ran
into errors or is out of 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 our customer device department or your local
distributor for assistance.
1. Check the lower left corner of the screen for error messages. Refer to Chapter 11
Troubleshooting Your Analyzer for solutions to any displayed error messages;
Other operations:
To print out the currently displayed L-J graph, press [PRINT]. To acquire help information,
press [HELP]. To return to the ”Controls” screen, press [MENU]
QC Table
At the “Controls” screen, press [F5] to enter the “QC Table” screen, as Figure 8-16 shows,
where every screen displays the results of 6 QC analyses. You can press [PgUp] or [PgDn] to
switch to the previous or next screen to view other results.
8-12
Using the QC Programs
If you want to delete all the saved results, press [DEL] and a message box will pop up to
confirm the deletion, as Figure 8-17 shows.
CLICK “Yes” to delete current result; CLICK “No” to abort the deletion.
If you want to transmit the saved QC results to an external computer, follow the steps given
below:
1. Press [F1] at “QC Table” screen to enter the dialog box shown in Figure 8-18;
8-13
Using the QC Programs
8-14
Using the QC Programs
One weakness of quality control using control materials is that the control material is usually
assayed only once a shift. If a significant change in calibration occurs, it might go undetected
for the remainder of the shift. The X-B represents the moving average of hematology values
calculated using an algorithm developed by Dr. Brian Bull. The X-B analysis uses the Bull
algorithm to monitor the performance of the analyzer by tracking the average red cell indices
MCV, MCH, and MCHC on the patient samples run through the instrument in batches of 20.
The Target Value for X-B is similar to the assay value for a commercial control. It is derived
from the patient population analyzed on the instrument. The Limit is the acceptable limit of
variation around the target value.
The X-B analysis demands random samples and therefore, the samples categorized by
diseases are not suitable for its use.
8.3.1 QC Editing
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Using the QC Programs
You must empty the X-B table before editing the X-B settings. If there are saved QC results
and settings, you need to delete them first. Press [DEL] and a message box will pop up to
confirm the deletion, as Figure 8-21 shows.
CLICK “Yes” to confirm the deletion; CLICK “No” to abort the deletion.
8-16
Using the QC Programs
"Sample Validity Setup" is to set up the ranges of valid RBC, MCV, MCH and MCHC results.
Only when the results of all these four parameters are within the specified ranges, the sample
results can be used for X-B QC calculation.To set the sample validity, in the “Lower” or
“Upper” field of the parameter you want to customize, Enter the desired numbers within the
ranges shown in the table below for the four parameters.
1.00×1012/L≤RBC≤8.00×1012/L 50.0fL≤MCV≤150.0fL
20.0pg≤MCH≤40.0pg 240g/L≤MCHC≤440g/L
All the entries should be numbers with only one decimal point.
Once the validity range is changed, the previous results will not be used in
the QC calculation as valid results, for example, if 20 valid samples are
needed for the X-B QC calculation, when you change the validity range after
10 groups of valid sample results have been acquired, these 10 groups of
results will be discarded, and only valid sample results generated afterwards
will be used in the QC calculation.
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Using the QC Programs
SELECT the combo box to the right of “X-B analysis”, SELECT “On” or “Off” from the
pull-down list to enable or disable the X-B analysis, as Figure 8-23 shows.
ENTER the expected mean and range respectively into the “Mean” box and “Range” boxes
of the parameters to be included in the QC run.
Deleting settings
Printing settings
Press [MENU] to exit the “X-B Edit” screen. a message box will pop up to remind you to save
the changes, as shows. CLICK “Yes” to save the changes; CLICK “No” to abort the changes.
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Using the QC Programs
X-B Table
Follow the steps introduced in Chapter 8.3.1.
X-B Graph
At the “X-B Table” screen, press [F2] to enter the “X-B Graph” screen, as Figure 8-25 shows.
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Using the QC Programs
The x-coordinate represents the number of X-B analyses performed; the y-coordinate
represents the results of the X-B analyses;
For every parameter, its X-B graph can display a maximum of 500 points, 30 points per
screen. The time at which the sample was analyzed is displayed to the right of “Time”. The
current cursor position and the number of all the saved points are displayed to the right of
“Loc./Total”.
For every parameter, the upper dash line represents the expected result + limit;
For every parameter, the upper dash line represents the expected result – limit;
For every parameter (e.g. MCV), the three numbers to the left of the X-B graph are
defined as follows:
The “■”points fallen between the upper and lower dash lines are within the expected ranges;
The “■”points fallen outside the upper and lower dash lines are out of the expected ranges
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 our customer device department or your local
distributor for assistance.
1. Check the lower left corner of the screen for error messages. Refer to Chapter 11
Troubleshooting Your Analyzer for solutions to any displayed error messages;
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Using the QC Programs
Press [↑] or [↓] to review the preceding or following screen; press [PgUp] or [PgDn] to review
the preceding or following result. The parameter value of the current point (the one the cursor
is located at) is displayed below the parameter. The location of the current point is displayed
in the “No.” field. The analysis time is displayed in the “Time” field.
8-21
9 Using the Calibration Programs
9.1 Introduction
The purpose of the calibration is to maintain system accuracy. Quality of the calibration
depends on the calibration materials and reagents used. You should only use the calibrator
and reagents specified by the manufacturer for the calibration. Store and use the calibrator
and reagents as directed by their instructions for use.
Calibration may be performed with commercial calibrator or fresh whole blood samples. Only
the directly measured parameters WBC, RBC, HGB, MCV, PLT, and MPV may be calibrated.
9-1
Using the Calibration Programs
9-2
Using the Calibration Programs
Check and make sure there are enough reagents for the calibration. You need to start over
the calibration if the reagents run out during the process.
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 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.
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 following requirements: WBC, RBC and HGB shall
be no greater than 0.5 % ; PLT shall be no greater than 1%.
It is recommended that you create a log table for your analyzer. This log table should contain
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Using the Calibration Programs
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
Enter the administrator password as instructed in Chapter 5.2.1 and then choose one or
several parameters among WBC, RBC, HGB, MCV and PLT for calibration.
ENTER the administrator password in the “Password” screen. Press [MENU] to enter the
system menu.
SELECT “Calibration→ Calibrator” (Figure 9-1) to enter the “Calibrator” screen (Figure
9-2).
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Using the Calibration Programs
ENTER the lot number of the calibrator to be used into the “Lot No.” box.
ENTER the expiration date of the calibrator to be used into the “Exp. Date” box.
ENTER the expected results (mean) into the “Mean” box of the parameters to be included in
the calibration.
Refer to the instructions of use of the calibrator for information on the lot
number, expiration date, expected results and limits.
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.
9-5
Using the Calibration Programs
Exit editing
When you have finished editing the desired settings, press [F2] to deactivate the edit boxes.
Use the specified calibrator. Using calibrator other than the specified will
lead to misleading results.
Refer to the instructions of use of the calibrator for how to store and use the
calibrator.
In the prediluted calibration mode, you cannot dispense diluent from the
analyzer. It is recommended that you prepare at least 7 cups of diluent
before starting calibrating the analyzer in the prediluted mode.
Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
2. Present a vial of mixed calibrator to the sample probe so that the tip is well into the tube,
and press the aspirate key and the analyzer will start aspirating sample;
3. When you hear the beep and the sample probe is out of the vial, remove the calibrator.
The sample probe will retract into the analyzer and the analysis progress will be
9-6
Using the Calibration Programs
4. When the analysis is finished, the result will be displayed on the screen and the sample
probe will be repositioned.
2. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 9-4 shows;
3. Present a clean sample tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 9-5 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.
4. When the dispensing is done, press [ENTER] to close the message box;
6. Add 20μL of calibrator into one of the prepared sample cups and mix them well;
8. Press the aspirate key to start the run. When you hear a beep and the sample probe is
out of the cup, remove the sample;
9. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
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Using the Calibration Programs
10. When the analysis is finished, the result will be displayed on the screen and the sample
probe will be repositioned.
Figure 9-6 A message box to warn you about the invalid results
If the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure 9-7 shows.
9-8
Using the Calibration Programs
CLICK “Yes” to save the results; CLICK “No” to abort the result. The saved results will be
displayed on the screen.
Repeat the above steps to run the calibrator 3 to 5 times (5 is recommended) and the
analyzer will automatically calculate the CVs and calibration factors, as Figure 9-8 shows.
The calculated calibration factor should be within the 75% to 125%. If not, there will be
flagged with a “*”. Other values will not be displayed. In case of an empty calibration factor, try
to find out the reason and if necessary, contact our customer device department or your local
distributor for assistance.
9-9
Using the Calibration Programs
CLICK ”Yes” to save the new calibration factors and enter the “Count” screen from the
system menu.
At the “Count” screen, run the calibrator or a normal-level control at least 3 consecutive times
and calculate the mean of the results. Compare the obtained means to the expected means.
Other operations
Printing new calibration factors
SELECT “Calibration → Fresh Blood” (Figure 9-10) to enter the “Fresh Blood” screen
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Using the Calibration Programs
(Figure 9-11).
At “Fresh Blood” screen, press [F1] to select the “Whole Blood” or “Prediluted” mode.
Selecting sample
When the mode is selected, press [F3] to choose the fresh blood sample whose reference
values you want to set.
Press [F2] to enable the edit boxes in the “Mean” column, as Figure 9-12 shows.
9-11
Using the Calibration Programs
ENTER the reference value into the “Mean” edit box. To correct any erroneous entry,
MODIFY the digit. After you have finished the editing, press [F2] to exit the editing state.
Figure 9-13 A message box to warn you about the invalid results
9-12
Using the Calibration Programs
If all the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure 9-14 shows. CLICK “Yes” to save the results to the “Fresh
Blood” screen; CLICK “No” to abort the result.
Repeat the above steps to run the sample 3 to 5 times (5 is recommended) and the analyzer
will automatically calculate the CV and calibration factor, as shows. Note that the CVs should
be within the ranges specified in Table 9-1.
The calculated calibration factors should be within the 75% to 125%. Any calculated value
that falls out of the calibration range will be flagged with a “*” at the upper right corner. Other
values will not be displayed. In case of an empty calibration factor, try to find out the reason
and if necessary, contact our customer device department or your local distributor.
9-13
Using the Calibration Programs
Follow the calibration steps of sample 1 to run at least another two fresh blood samples.
When you have obtained the calibration factors of at least 3 fresh blood samples, you can
press [F1] to enter the “Calculate” screen as Figure 9-16 shows.
This screen can maximum display the calibration factors for 5 fresh blood samples. Any factor
out of the calibration range will be flagged by “*” at the upper right corner. Other values will
not be displayed. In case of an empty calibration factor, try to find out the reason and if
necessary, contact our customer service department or your local distributor. For every
parameter, the analyzer will calculate the average calibration factor, which serves as the new
calibration factor, only when there are at least 3 valid calibration factors, as the WBC in
Figure 9-16 indicates. Otherwise the new factor will be blank, as the RBC in Figure 9-16
indicates.
9-14
Using the Calibration Programs
CLICK ”Yes” to save the new calibration factors; CLICK “No” to abort the result.
Method one:
1. Prepare 3 to 5 normal fresh blood samples and run each one of them on a reference
analyzer at least 3 consecutive times. Calculate the mean (MEAN 1) and SD (SD 1) of
every sample.
2. Run the same samples on your analyzer for the same number of times and calculate the
mean (MEAN 2). The MEAN 2 should be within MEAN 1 ± 2SD. If any of the samples
fails to reach the criterion, call our customers service department or your local distributor.
Method two:
At the “Count” screen, run the calibrator at least 5 consecutive times and calculate the
means of the results. The means should be within the expected ranges supplied by the
manufacturer. If not, contact our customer service department or your local distributor.
Other operations
If calibration data (calibration results, CV or new factors) exist
If you press [F2], a dialog box will pop up to warn you, as Figure 9-18 shows. Press [ENTER]
to return to the “Fresh Blood” screen.
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Using the Calibration Programs
If the valid results are less than three (the CV and new factors are not available yet).
If you press [F3], a dialog box will pop up to warn you about the data loss, as Figure 9-19
shows.
To switch the modes, CLICK “Yes” and the saved data will be cleared; Otherwise, CLICK
“No” to exit.
9-16
Using the Calibration Programs
SELECT “Calibration → Manual” (Figure 9-20) to enter the “Manual” screen ( Figure 9-21).
The left of the “Manual" screen displays the available calibration modes – “Whole blood”
and “Prediluted”. The right of the “Manual” screen displays the calibration factors of WBC,
RBC, HGB, MCV, PLT and the time the factors are saved.
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Using the Calibration Programs
mentioned in the formula above) is 8.4 and the current whole blood calibration factor is 98.9
%, analyze this calibrator in the whole blood mode for ten times (n=10)and the results are
8.1, 8.0, 8.1, 8.1, 8.3, 8.3, 8.2, 8.0, 8.1, 8.3, CV=1.5%, Mean=8.16。
Since the calculated CV meets the requirement of Table 9-1, the mean value, 8.12, is valid
and the new calibration factor can be calculated as follows:
The calculated new calibration factor should be within 75% to 125%. If not, try to find out the
reason and if necessary, call our customer service department or your distributor for
assistance.
If the reproducibility of the calibrated parameter does not meet the requirements of Table 9-1,
you must try to find out the reason and re-run the calibrator after you have solved the problem.
If necessary, contact our customer service department or your local distributor for assistance.
3. ENTER the calculated calibration factor into the corresponding boxes. To correct an
erroneous entry, DELETE the wrong digit and enter the correct digit.
9-18
Using the Calibration Programs
Seeing the box, CLICK “Yes” and re-enter the factors. If the changed factors are all within the
calibration range, a dialog box will pop up to remind you to save the new factors, as Figure
9-24 shows. CLICK ”Yes” to save the new calibration factors
At the “Count” screen, run the calibrator or a normal-level control at least 3 consecutive times
and calculate the mean of the results. Compare the obtained means to the expected means.
If not, contact our customer device department or your local distributor for assistance.
Other operations
Printing new calibration factors
9-19
10 Maintaining Your Analyzer
10.1 Introduction
Preventive and corrective maintenance procedures are required to keep the analyzer 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.
Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
Only parts supplied by us can be used for maintenance. For any questions,
contact our customer service department or your local distributor.
10-1
Maintaining Your Analyzer
Everyday If you are to use this analyzer 24 hours a day, perform the “Probe
cleanser cleaning” procedure everyday.
When the analyzed samples add up to 20, the analyzer will perform
the auto-cleaning procedure.
Run the QC program everyday. See Chapter 8 Using the QC
Programs for details.
Every Month You should use the supplied probe localizer to calibrate the
position of the probe to that of the probe wipe. The analysis result
is sensitive to their alignment.
As needed When you think the bath might be contaminated, perform the
“Clean the bath” procedure.
When the analyzed add up to 600, the analyzer will remind you to
perform the “Probe cleanser cleaning” procedure.
When the analyzed samples add up to 150, the analyzer will
remind you to perform the “Clean Probe Wipe” procedure.
When the analyzed samples add up to 100, the analyzer will
remind you to perform the “E-Z Cleanser Cleaning” procedure.
When this analyzer is not to be used for two weeks, perform the
“Prepare to Ship” procedure to empty and wash the fluidic lines
and then wipe the analyzer dry and wrap it up for storage.
To obtain reliable analysis results, this analyzer needs to work in a
normal status. Run the “Self-test” items regularly to check the
status of this analyzer.
When this analyzer gives alarms for clogging, you can perform the
“Flush Aperture” or “Zap Aperture” procedure, or press [F2] to
unclog the aperture.
If you see other error messages, see Chapter 11
Troubleshooting Your Analyzer for solutions.
10-2
Maintaining Your Analyzer
Press [MENU] to enter the system menu. SELECT “Service → Maintenance” (Figure 10-1)
to enter the “Maintenance” screen (Figure 10-2).
Diluent Prime
Rinse Prime
Lyse Prime
Zap Aperture
Flush Aperture
10-3
Maintaining Your Analyzer
Lyse Test
Clean Bath
Drain Bath
Drain Tubing
Prepare to Ship
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
After installing new reagents, let the reagents stand for a while before using
them.
You should perform the “Diluent prime” procedure to prime the diluent tubing when
you have installed a new container of diluent without shutting the analyzer.
At the “Maintenance” screen, SELECT “Diluent prime” to prime the tubing and the priming
progress will be displayed at the bottom of the screen, Figure 10-3 shows. When the priming
is done, the screen will return to the initial state.
10-4
Maintaining Your Analyzer
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
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.
After installing new reagents, let the reagents stand for a while before using
them.
You should perform the “Rinse prime” procedure to prime the rinse tubing when
you have installed a new container of rinse without shutting the analyzer.
10-5
Maintaining Your Analyzer
At the “Maintenance” screen, SELECT “Rinse prime” to prime the tubing and the priming
progress will be displayed at the bottom of the screen, as Figure 10-4 shows. When the
priming is done, the screen will return to the initial state.
After installing new reagents, let the reagents stand for a while before using
them.
You should perform the “Lyse prime” procedure to prime the lyse tubing when
you have installed a new container of lyse without shutting the analyzer.
10-6
Maintaining Your Analyzer
At the “Maintenance” screen, SELECT “Lyse prime” to prime the tubing and the priming
progress will be displayed at the bottom of the screen, as Figure 10-5 shows. When the
priming is done, the screen will return to the initial state.
At the “Maintenance” screen, SELECT “Zap aperture” to zap the apertures and the zapping
progress will be displayed at the bottom of the screen, as Figure 10-6 shows. When the
zapping is done, the screen will return to the initial state.
10-7
Maintaining Your Analyzer
At the “Maintenance” screen, SELECT “Flush aperture” to flush the aperture and the
flushing progress will be displayed at the bottom of the screen, as Figure 10-7 shows. When
the flushing is done, the screen will return to the initial state.
You can soak the bath and fluidic lines with the probe cleanser, an alkaline detergent, by
10-8
Maintaining Your Analyzer
performing the “Probe cleanser cleaning” procedure. If your analyzer is to run 24 hours a
day, you should perform this procedure.
2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser. When you
hear the beep and the sample probe is out of the bottle, remove the cleanser. The
analyzer will start priming process, as Figure 10-8 shows;
3. When the priming is done, the analyzer will start the 5-minute soaking process, as Figure
10-9 shows and you may press [ENTER] to stop it before the time is due. Note that a
shortened priming process may not be as effective as a complete one;
10-9
Maintaining Your Analyzer
4. When the soaking is done, the analyzer will start the cleaning process, as Figure 10-10
shows, after which screen will return to the initial state;
To make sure this analyzer functions normally, every time the accumulated analyzed samples
reach 600, a message box will pop up to remind you to perform the “probe cleanser
cleaning” procedure, as Figure 10-11 shows. CLICK “Yes” to proceed with the cleaning;
CLICK “No” to cancel the cleaning.
You can use the E-Z cleanser, an enzyme based, isotonic cleaning solution and wetting agent,
to clean the tubing and bath by performing the “E-Z cleanser cleaning” procedure.
Follow the steps given below to perform the procedure:
10-10
Maintaining Your Analyzer
2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser. When you
hear the beep and the sample probe is out of the bottle, remove the cleanser. This
analyzer will automatically prime the bath and fluidic lines with the aspirated cleanser and
the progress is displayed on the screen, as Figure 10-12 shows;
3. When the priming is done, the analyzer will start the 10-minute soaking process, as
Figure 10-13 shows.
4. When the soaking is done, the analyzer will start the draining process, as Figure 10-14
shows. When the draining is done, the whole procedure is over and the screen will return
10-11
Maintaining Your Analyzer
If the accumulated analyzed samples reach 100, a message box, as Figure 10-15 shows, will
pop up to remind you to perform the “E-Z cleanser cleaning” procedure. If you want to do so,
CLICK “Yes “. Otherwise, CLICK “No” to cancel the cleaning.
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
10-12
Maintaining Your Analyzer
In case of any abnormal WBC counts or histograms, you can perform the “Lyse test”
procedure to check whether the lyse can be dispensed properly.
Follow the steps given below to do so:
1. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-16) on the right plate;
2. Follow the arrow shown in Figure 10-17 to push and remove the right plate;
3. Remove the screws fixing the shielding box of the bath, as Figure 10-18 shows;
10-13
Maintaining Your Analyzer
4. Remove the shielding box to expose the bath, as Figure 10-19 shows;
5. SELECT “Lyse test”. The analyzer will automatically drain the bath and then dispense
2ml of lyse into the bath;
6. Check the scale to see whether the lyse has reached the expected line (the second from
the bottom). If so, press [ENTER] and the analyzer will automatically flush the bath and
dispense lyse and the test is done;
7. If not, repeat steps 5 and 6 several times. If all the tries have failed, check whether the
lyse has run out or the lyse pickup tube is not properly connected to this analyzer. If the
lyse is still enough and the tube is well connected to the analyzer, contact us or your local
distributor for assistance.
10-14
Maintaining Your Analyzer
SELECT “Clean bath” to start the cleaning procedure, as Figure 10-20 shows. When the
cleaning is done, the screen will return to the initial state;
10-15
Maintaining Your Analyzer
3. When the draining is done, the screen will display the residual time of draining bath;
4. Check the bath and the tubing below them for residual fluid. If there is no fluid, press
[ENTER] to prime the bath with diluent, as Figure 10-23 shows. When the priming is done,
the screen will return to the initial state;
10-16
Maintaining Your Analyzer
5. If there is fluid left, turn off the analyzer and call our customer service department or your
local distributor for assistance.
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
You can perform the “Drain tubing” procedure to drain the fluidic system. Follow the steps
given below to do so:
1. Press the appropriate arrow keys ([←][→] [↑][↓]) as needed to move the cursor to “Drain
tubing”;
2. Remove the diluent, rinse and lyse pickup tubes from the back of the analyzer;
10-17
Maintaining Your Analyzer
4. When the draining is done, the screen will display “Turn off this analyzer” and you
should turn off the power switch.
2. Press [ENTER] on the keypad, and a message box shown in will pop up;
3. SELECT “Yes”, and then present the probe cleanser to the sample probe as instructed
by the pop-up message box. Press [ENTER] to aspirate the probe cleanser;
4. When you hear the beep and the sample probe is out of the bottle, remove the cleanser;
10-18
Maintaining Your Analyzer
5. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-26) on the right plate as instructed by the pop-up message
box;
6. Follow the arrow shown in Figure 10-27 to push and remove the right plate;
7. Follow the instructions displayed on the screen to place an empty cup, whose diameter
should be no less than 8cm, below the sample probe (as shown in Figure 10-28);
10-19
Maintaining Your Analyzer
Probe wipe
Place an empty
cup right under
the probe wipe
8. Press [ENTER] to soak the probe wipe with the aspirated cleanser. The soaking progress
will be displayed on the screen, as Figure 10-29 shows;
9. When the soaking is done, wipe the bottom of the probe wipe with a probe
cleanser-dipped cloth that does not leave debris as instructed by the pop-up message
box;
10. Press [ENTER] to flush the block and the interior of the probe and the flushing progress is
displayed on the screen, as Figure 10-30 shows;
10-20
Maintaining Your Analyzer
Figure 10-30 Flush the block and the interior of the probe
11. After the flushing is done, the screen returns to the initial state.
When the accumulated analyzed samples reach 2000, a message box will pop up to remind
to clean the probe wipe, as Figure 10-31 shows. CLICK “Yes” to do the procedure; CLICK
“No” to abort the procedure.
1. Press the appropriate arrow keys ([↑][↓][←][→]) to move the cursor to ”Prepare to
ship”. Remove the diluent, rinse and lyse tubing from the containers following the
instructions displayed on the screen;
2. Press [ENTER] and a message box will pop up to ask you to confirm this operation, as
Figure 10-32 shows;
10-21
Maintaining Your Analyzer
3. CLICK “No” if you want to abort this operation; CLICK “Yes” to proceed with the
operation. The analyzer starts to drain the fluidic lines and the progress is displayed on
the screen, as Figure 10-33 shows.
4. After draining the tubing, follow the instructions displayed on the screen (Figure 10-34) to
put the rinse, diluent and lyse tubing into distilled water and press [ENTER] to flush this
analyzer with the distilled water;
10-22
Maintaining Your Analyzer
5. When the washing is over, follow the instructions displayed on the screen to remove the
rinse, diluent and lyse tubing from the distilled water and press [ENTER] to drain the
tubing again;
6. Turn off the analyzer when the screen displays “Turn off the analyzer”;
10-23
Maintaining Your Analyzer
The items displayed in the “System Status” screen reflect how the analyzer is functioning
and contribute significantly to diagnosing analyzer errors. You may follow the instructions
given below to check those items.
Press [MENU] to enter the system menu and SELECT “Service → Status”, as Figure 10-35
shows, to enter the “Status” screen, as Figure 10-36 shows.
At the “Status” screen you can only view the displayed status information and reference
ranges without changing them.
10-24
Maintaining Your Analyzer
Press [MENU] to enter the system menu and SELECT “Service → Self-test”, as Figure
10-37 shows, to enter the “Self-test” screen, as Figure 10-38 shows.
This area displays the test groups. The available self-test items are divided into four groups,
“Tubing”, “Machine”, “Valve” and “Circuit”.
Press [F1] to select the desired group. The selected group is preceded by a ⊙.
10-25
Maintaining Your Analyzer
This area displays the items included in the test group and the test results.
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 print out
the test results (except for the results of the tests), press [PRINT].
Count Time
It measures the duration of a WBC and RBC count, namely how many seconds it takes for
the aspirated fluid flows from the first sensor to the second.
Aperture(v)
It measures the voltage (v) over the aperture.
Vacuum
It checks whether the vacuum system functions normally.
Pressure
It checks whether the system flushes the aperture at a normal pressure.
Filter
It checks whether the filter functions normally.
10-26
Maintaining Your Analyzer
To conduct the following tests, SELECT the desired test and the results will be displayed
later.
Syringe motor
The syringe motor controls the aspiration volume. This test checks whether the motor
functions normally.
Rotation motor
The rotation motor rotates the sample probe inside the analyzer. This test checks whether the
motor functions normally.
Elevator motor
The elevator motor controls elevation of the sample probe. This test checks whether the
motor functions normally.
Print
This test checks whether the recorder or printer functions normally. If normal, when you press
[ENTER], the recorder or printer will print out a test page; if abnormal, the screen will display
the corresponding error message and you can see Chapter 11 Troubleshooting Your
Analyzer for solutions.
10-27
Maintaining Your Analyzer
To test a valve, SELECT the valve. If the valve goes through an Off-On-Off sequence without
making any abnormal sound, it passes the test. Otherwise, something may be wrong with the
valve.
To conduct the test, SELECT “A/D interrupt” and the test result will be displayed later.
10-28
Maintaining Your Analyzer
10.6 Log
The log records all the major events taking place during the running of this analyzer. It helps
the service engineers diagnose system errors.
Press [MENU] to enter the system menu and SELECT “Service→Log”, as Figure 10-42
shows to enter the “Log” screen, as Figure 10-43 shows.
The recorded events are divided into three groups, “All”, “Settings” and “Other”(including
setting discriminators, system self-test and updating system software), which are all listed on
the left of the screen. All the recorded events are listed on the right of the screen by default.
You can press [F1] to select the desired group and the right of the screen will display the
events of the selected group only. Every screen displays 10 events. You can press [↑] or [↓]
to check the events one by one or press [PgUp] or [PgDn] to check the events on the
previous or next screen. If you want to print out the displayed events, press [PRINT]. If you
want to acquire help information, press [HELP].
10-29
Maintaining Your Analyzer
For every recorded event, the “NO.” column displays the sequences of the recorded events;
the “Time” column displays the time when this event occurred; the “Type” column displays
the event type; the “Times” column displays how many times (1 to 255) this event occurred
and if it occurred more than 255 times, the excessive events will be recorded from 1 to
another log file; the “Information” column displays extra information regarding the event.
This analyzer can save a maximum of 1000 log files and once the maximum number has
been reached, the newest log will automatically cover the oldest one.
10-30
Maintaining Your Analyzer
To view the system configuration, press [MENU] to enter the system menu, and SELECT
“Service→Config.” , as Figure 10-44 shows, to enter the “Config.” screen, as Figure 10-45
shows.
Every screen displays 13 items and you can press [↑] or [↓] to select the item you want to
see, or press [PgUp] or [PgDn] to go to the previous or next screen. If you want to print out
the configuration, press [PRINT]. If you want to acquire help, press [HELP].
10-31
Maintaining Your Analyzer
Press the [MENU] to enter the system menu and SELECT “Service→Print.” , as Figure
10-46 shows, to enter the “Print” screen, as Figure 10-47 shows.
The printing tasks are queued in this screen, where you can view the all and delete those
waiting to be processed. Once something goes wrong with the printing device, the task being
processed will be deleted and the queued tasks will keep waiting. Once the system finds the
error has been removed, it will resume printing and process the tasks from the first one. Note
that you cannot change the sequence of the queued tasks.
You can perform the following operations at the “Print” screen:
10-32
Maintaining Your Analyzer
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
The relative position between the sample probe and probe wipe has influence on the analysis
results. In the accessory box, there is a sample probe localizer, as Figure 10-48 shows. You
need to use the localizer to adjust the position of the sample probe if you have replaced probe
wipe, or observed motor error, or incorrect analysis result. Also, as required by regular
maintenance, you should use the localizer to adjust the position of the sample probe monthly.
2. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-49) on the right plate.
3. Follow the arrow shown into push and remove the right plate;
10-33
Maintaining Your Analyzer
4. Press [F1] to select the “Machine” group and SELECT “Elevator motor”, as Figure
10-51 shows;
10-34
Maintaining Your Analyzer
6. Press [↑] to move the sample probe upward and press [→] to move the probe to above
the bath, as Figure 10-53 shows;
10-35
Maintaining Your Analyzer
8. Remove the probe from the probe wipe and insert the localizer into the probe wipe from
the bottom, as Figure 10-55 shows;
9. Insert the probe into the probe wipe until it reaches the localizer, as Figure 10-56 shows;
10. Retighten the screw to fix the probe and remove the localizer to wrap up the adjustment.
10-36
Maintaining Your Analyzer
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
2. Pull the loosen probe wipe upward to remove the probe wipe and disconnect the tubes
from the probe wipe (pay attention to the correspondence between the tubes and the
connectors), as Figure 10-57 shows;
3. Install a new block and connect the tubing end with the black marking to the connector
below the block;
4. Calibration to the sample probe position should be performed after replacing the probe
wipe. Refer to Chapter 10.9.
10-37
Maintaining Your Analyzer
1. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-58 ) on the right plate;
2. Follow the arrow shown in Figure 10-59 to push and remove the right plate;
10-38
Maintaining Your Analyzer
4. Remove the filter and take a new one from the accessory kit and install it.
10-39
Maintaining Your Analyzer
Make sure the power supply of the analyzer has been cut off before
maintenance.
If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.
Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.
Make sure the alcohol volatilizes completely before using the recorder to
print.
You should maintain the recorder every two months. Do as follows to maintain your recorder:
1. Turn off the analyzer and cut off the power supply;
2. Open the recorder door and take out the recorder paper;
3. Gently wipe the roller from left to right using cotton swabs;
4. Roll the roller and repeat step 3 to clean off all debris and stains on the roller;
5. Gently wipe the heating part of the recorder head from left to right using cotton swabs
dipped with alcohol (no drops) to clean off all debris and stains on the head;
6. Wipe off the alcohol remaining on the heating part of the recorder head using dry cotton
swabs;
7. Wait at least 20 minutes till alcohol on the heating part of the recorder head volatilizes
completely, and then install recorder paper and close the recorder door.
10-40
Maintaining Your Analyzer
See the figure above to find the heating part of the recorder head and the roller when the
recorder door is opened.
10-41
11 Troubleshooting Your Analyzer
11.1 Introduction
The analyzer continuously monitors the status of the system and displays pertinent
information in the left corner of the “Count” screen (the Error Message area). If a problem is
detected, the Error Message area displays the corresponding error message. This chapter
contains information that is helpful in locating and correcting problems that may occur during
operation of your analyzer.
Unless otherwise instructed, always turn off the power before trying to fix
the error.
11-1
Troubleshooting Your Analyzer
Liquid drips Damaged pump hose or blocked 1. Turn off the power and wipe the
from analyzer filter. analyzer dry;
11-2
Troubleshooting Your Analyzer
The analyzer can provide error messages. See the tables below for the error messages and
their probable causes and recommended actions. If the problem still remains after you have
tried the recommended solutions, contact our customer device department or your local
distributor.
HGB error HGB blank voltage within 0 V 1. Do the Probe cleanser cleaning
to 3.2 V or 4.9 V to 5 V. procedure as instructed in Chapter
10.3.6.;
11-3
Troubleshooting Your Analyzer
HGB adjust HGB blank voltage within 3.2 1. Do the probe cleanser cleaning
V to 3.4 V or 4.8 V to 4.9 V. procedure as instructed in Chapter
10.3.6.;
11-4
Troubleshooting Your Analyzer
WBC bubbles 1. Diluent or rinse running 1. Check if the diluent or rinse has run
out; out. If so, change a new container of
11-5
Troubleshooting Your Analyzer
RBC bubbles 1. Diluent or rinse running 1. Check if the diluent or rinse has run
out; out. If so, change a new container of
11-6
Troubleshooting Your Analyzer
Barcode error 1. Poor connection between 1. Check if the analyzer is well connected
the scanner and the to the analyzer;
analyzer; 2. Check if the bar-code is valid;
2. Invalid bar-code. 3. If the problem remains, contact our
customer device department or your
local distributor.
Barcode com Poor connection between the 1. Check if the analyzer is well connected
scanner and the analyzer. to the analyzer;
error
2. If the problem remains, contact our
customer device department or your
local distributor.
Printer out of Printer paper running out or 1. Check if there is printer paper;
not properly installed.
paper 2. Check if the printer paper is well
installed.
Printer offline Poor connection between the Check if the printer is well connected to the
printer and the analyzer. analyzer.
Recorder com 1. Poor connection between 1. Print again;
the recorder and the 2. If the problem remains, shut down the
error
analyzer; analyzer and restart it again, and then
print again;
2. Damaged recorder.
3. If the problem remains, shut down the
analyzer and contact our customer
device department.
Recorder out of Recorder paper running out 1. Check if the recorder paper has run
or not properly installed. out. If so, install the paper as
paper
instructed by Chapter 4.4.2;
11-7
Troubleshooting Your Analyzer
Recorder too hot Recorder head too hot. 1. Stop using recorder and cool it for 10
minutes and then print again;
2. If the problem remains, shut down the
analyzer and restart it again, and then
print again;
Lyse out Insufficient lyse or wrong lyse 1. Check if there is sufficient lyse left. If
volume setting. so, access “Setup → Settings →
Reagents” and adjust the remaining
lyse volume as instructed by Chapter
5.3.1;
Diluent expired Expired diluent or wrong 1. Check if the diluent has expired. If so,
expiration setting change a new container of diluent as
instructed by Chapter 4.4.1;
Rinse expired Expired rinse or wrong 1. Check if the rinse has expired. If so,
expiration setting change a new container of rinse as
instructed by Chapter 4.4.1;
Lyse expired Expired lyse or wrong 1. Check if the lyse has expired. If so,
expiration setting change a new container of lyse as
instructed by Chapter 4.4.1;
Vacuum filter The air inside the vacuum 1. Enter “Service → Self–test →
chamber is not extracted Tubing”to test the filter as instructed
error
within the given time. in Chapter 10.5.1;
11-8
Troubleshooting Your Analyzer
local distributor.
Real-time clock 1. Someone tempered with 1. Enter “Setup → Settings → Date &
error the on-board battery off the Time” screen and reset the time as
board; instructed by Chapter 5.3.3;
3. Poor connection between 2. If the test result is normal, the error will
Rotation motor 1. Jammed sample probe; 1. Open the front door and check if the
error 2. Poor contact of the signal sample probe is jammed;
Elevator motor 1. Jammed sample probe; 1. Open the front door and check if the
error 2. Poor contact of the signal sample probe is jammed;
11-9
Troubleshooting Your Analyzer
A/D error Something is wrong with the 1. Enter the “Service → Self-test →
A/D part of the CPU board. Circuit” screen to test the A/D
interrupt as instructed by Chapter
10.5.4.;
Vacuum error The vacuum degree does not 1. Check whether the external tubing is
reach the expected value pressed;
within the given time.
2. If not, enter “Service→ Self-test →
Tubing” to check the vacuum as
instructed by Chapter 10.5.1..;
Pressure error The pressure inside the 1. Check whether the external tubing is
pressure chamber does not pressed;
reach the expected value
2. If not, enter “Service→ Self-test →
within the given time
Tubing”screen to check the pressure
as instructed by Chapter 10.5.1..;
Diluent empty Insufficient diluent or wrong 1. Check if there is sufficient diluent left. If
diluent volume setting. so, access “Setup → Settings →
Reagents” and adjust the remaining
diluent volume as instructed by
Chapter 5.3.1;
Rinse empty Insufficient rinse or wrong 1. Check if there is sufficient rinse left. If
rinse volume setting. so, access “Setup → Settings →
11-10
Troubleshooting Your Analyzer
Waste full The waste container is full. Empty the waste container and reset
usable volume of the waste container as
instructed by Chapter 5.3.1.
File error Something is wrong with the Turn off the power and contact our
analyzer’s file system. customer device departmentor your local
distributor.
Dynamic Something is wrong with the Turn off the power and contact our
analyzer’s memory. customer service department or your local
memory error
distributor.
+12 V power Something is wrong with the Shut down the analyzer and contact our
error power board. customer service department or your local
distributor.
-12 V power Something is wrong with the Shut down the analyzer and contact our
error power board. customer service department or your local
distributor.
56V power error Something is wrong with the Shut down the analyzer and contact our
power board. customer service department or your local
distributor.
11-11
12 Appendices
A Index
count
principle, 3-1
A
procedure, 6-9
aspiration, 3-2 CV
definition, 7-16
formula, 7-16
B
bath D
clean, 10-15
drain, 10-15 diluent
calibration E
calibrator, 2-14, 9-4
manual, 9-17 environment, B-5
preparations, 9-3 error
procedures, 9-3 +12V power error, 11-11
purpose, 9-1 -12V power error, 11-11
clog 56V power error, 11-11
RBC, 11-5 A/D error, 11-10
WBC, 11-4 ambient temp. abnormal, 11-3
controls, 2-14 barcode com error, 11-7
A-1
Appendices
A-2
Appendices
N table, 8-12
NRBC, 3-6
R
O RBC
definition, 3-9
optical sensors, 3-4 measurement, 3-9
operating range, B-2
RDW-CV, 3-10
P
reagent
PCT recorder
PLT
definition, 3-11 S
operating range, B-2
power sample
fuse, 4-2 analysis, 6-9
voltage, 4-2 review, 7-1
prediluted mode sample probe
analyzer, 6-19 adjust, 10-33
sample collection and handling, 6-7 sample probe localizer, 10-33
prepare to ship, 10-21 shutdown, 6-28
printer specification, B-1
connection, 4-10 system
format, 5-7 self-test, 10-25
probe cleanser status, 10-24
A-3
Appendices
T V
table valve
sample, 7-7 test, 10-27
searched, 7-29
throughput, B-2
W
transmission
at QC table screen, 8-13 WBC
at review screen, 7-25 definition, 3-6
troubleshooting, 11-1 operating range, B-2
weight, B-6
unpacking, 4-4
A-4
B Specifications
B.1 Classification
According to the CE classification, the analyzer is an In Vitro Diagnostic device.
B.2 Reagents
Diluent M-18D DILUENT
Rinse M-18R RINSE
Lyse M-18CFL LYSE
E-Z Cleanser(Enzyme cleanser) M-18E E-Z CLEANSER
Probe Cleanser M-18P PROBE CLEANSER
Calibrator Specified by manufacturer
Controls Specified by manufacturer
B.3 Parameters
Table B-1 Directly measured parameters and histograms
Parameter Abbreviation Default
9
White Blood Cell or leukocyte WBC 10 /L
Red Blood Cell or erythrocyte RBC 1012/L
Hemoglobin Concentration HGB g/L
Platelet PLT 109/L
WBC histogram WBC Histogram /
RBC histogram RBC Histogram /
PLT histogram PLT Histogram /
B-1
Appendices
Diameter Length
Aperture 80 μm 70 μm
B.4.3 Throughput
B-2
Appendices
B.5.4 Carryover
Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 0.5 %
PLT ≤ 1.0 %
B-3
Appendices
B.5.6 Compatibility
Deviation ranges: WBC≤2.5%, RBC≤1.9%, HGB≤1.9%, PLT≤5.3%, HCT≤3.0%, MCV≤1.2%
B.6.1 Keypad
18-key keypad.
B.6.2 Keyboard
PS/2 keyboard.
B.6.4 Display
TFT LCD (LED backlight), 800×600
B.6.5 Recorder
Built-in thermal recorder that supports two printing formats and auto printing
Width: 50 00.7 mm
B.6.7 Printer(optional)
Epson LQ300k+ II
Epson 630K
B.6.8 Interfaces
A keyboard interface
B-4
Appendices
A power supply for the floppy disk drive(only to be used with the power cable supplied by
us).
Fuse: 250 V T4 A
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.9 Sound
Maximal sound: 65 dB
Relative humidity: 30 % to 85 %;
B-5
Appendices
Relative humidity: 10 % to 93 %
B.12 Dimensions
Depth Width Height
38.6 cm 32.2 cm 43.7 cm
B.13 Weight
Less than 23 kg
B.14 Contraindications
None.
B-6
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
Before turning on the analyzer, make sure the input voltage meets the above
requirements.
When moving the analyzer, face the front of the analyzer and carry it from
the bottom with hands!
The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
To avoid personal injury, keep your clothes, hair and hands away from such
moving parts as the sample probe.
Unless otherwise instructed, always turn off the power before trying to fix
the error.
Make sure the power supply of the analyzer has been cut off before
maintenance.
C-2
Appendices
C.3 Cautions
Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.
Only parts supplied by us can be used for maintenance. For any questions,
contact our customer service department or your local distributor.
Use 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.
Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.
Do not leave the recorder door open unless you install paper or remove
trouble.
Improper installation of recorder paper may jam the paper and/or result in
blank printout.
If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.
Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.
Make sure the alcohol volatilizes completely before using the recorder to
print.
C-3
Appendices
C.4 Notes
This analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.
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.
Before connecting the power cord, make sure the power switch at the back
of the analyzer is placed in the off (O) position.
Retain the shipping carton and all the packing materials, as they can be
used for packaging if analyzer must be reshipped.
Store and use the reagents as directed by instructions for use of the
reagents.
When you have changed the diluent, rinse or lyse, run a background to see
if the results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all
the reagents. Never use expired reagents.
After installing new reagents, let the reagents stand for a while before using
them.
The recorder paper is treated on one side for printing. To determine which
side is the printing side, gently scratch both sides with a fingernail and the
one with visible nail trace left is the printing side.
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
C-4
Appendices
after collection.
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
refrigerated samples at room temperature for at least 30 minutes before
running them.
Mix any sample that has been prepared for a while before running it.
After mixing the capillary sample with the diluent, wait 5 minutes before
running the sample.
Keep the sample probe tip away from the tube bottom; otherwise the
aspiration volume may be inaccurate.
When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.
Fur and skin debris may block the aperture. Keep the sample clean before
using the analyzer to analyze it.
Use the specified controls. Using controls other than the specified will lead
to misleading results.
Refer to the instructions of use of the controls for how to store and use the
controls.
1.00×1012/L≤RBC≤8.00×1012/L 50.0fL≤MCV≤150.0fL
C-5
Appendices
20.0pg≤MCH≤40.0pg 240g/L≤MCHC≤440g/L
All the entries should be numbers with only one decimal point.
Once the validity range is changed, the previous results will not be used in
the QC calculation as valid results, for example, if 20 valid samples are
needed for the X-B QC calculation, when you change the validity range after
10 groups of valid sample results have been acquired, these 10 groups of
results will be discarded, and only valid sample results generated afterwards
will be used in the QC calculation.
Refer to the instructions of use of the control for information on the lot
number, expiration date, open-vial stability days, expected results and limits.
The entered expiration date should be either the expiration date printed on
the labeling or the open-vial expiration date. It is earlier.
The open-vial expiration date is calculated as follows: the date that vial is
opened + the open-vial stability days.
At the “QC Edit” screen, if you want to correct an erroneous entry, MODIFY
the wrong digit.
Use the specified calibrator. Using calibrator other than the specified will
lead to misleading results.
Refer to the instructions of use of the calibrator for how to store and use the
calibrator.
When installing the analyzer, our authorized personnel will select a proper
communication protocol that matches the data management software
configured.
Remove the protective paper between the recorder head and the roller
inside the recorder before installing recorder paper.
C-6
Appendices
recommended that you purchase the recorder paper from the analyzer
manufacturer.
C-7
Appendices
C.5 Biohazard
C-8
D Communication
D.1 Introduction
The analyzer provides two communication protocols to match the data management software
in the PC connected to the analyzer based on the supported sample ID length. If the software
supports sample IDs of up to 8 digits, select the 8ID communication protocol; if the software
supports sample IDs of up to 15 digits, select the 15ID communication protocol.
While installing the analyzer, the authorized personnel will choose the
appropriate communication protocol based on the data management
software configured on site.
The analyzer can transmit the sample data and QC data to an external computer (a host)
through its RS-232 serial port. The transmission can be conducted either automatically or
through the command of the operator after the completion of the sample analysis. This
section gives detailed discussion about the setup of transmission parameter, RS-232 serial
port and the data transmission format, therefore, providing detailed information for the
software engineers to program and for the user to conveniently perform transmission.
D-1
Appendices
D.2 Connection
The analyzer can be connected with an external computer through a DB9 connector. The
pins of the DB9 connector are shown in Figure D-1.
Pin description:
DCD: Carrier Detect
RXD: Receive Data
TXD: Transmit Data
DTR: Data Terminal Ready
GND: Signal Ground
DSR: Data Set Ready
RTS: Request to Send
CTS: Clear to Send
RI: Ring Indicator
The analyzer communicates with a host through serial port 2, using Pin2, Pin 3 and Pin 5.
The maximum transmission distance is 12 meters.
D-2
Appendices
D.3.2 Description
Symbols
[ENQ] 0x05
[STX] 0x02
[EOT] 0x04
[EOF] 0x1A
[ETX] 0x03
[ACK] 0x06
[NACK] 0x15
"A" 0x41
"B" 0x42
"C" 0x43
"#" 0x30-0x39
"*" 0x2A
D.3.3 Programming
If the Handshake is off, the analyzer will transmit the body of the text without acknowledging
the presence of an external computer.
If the Handshake is on, the analyzer will communicate with the external computer in following
procedures:
1. The analyzer sends an ENQ (05 Hex), then waits up to 4 seconds for the external
computer to respond. If the external computer does not respond, then one more ENQ (05
Hex) is tried. If it fails again, the analyzer aborts the transmission and reports a
transmission error;
2. The external computer must respond by sending an ACK (06 Hex). If any other response
is received, another ENQ (05 Hex) will be sent by the analyzer (maximum two ENQ [05
Hex] will be sent);
Body of text
EOT (04 Hex)
ETX (03 Hex)
D-3
Appendices
4. Disconnection.
The analyzer sends an ETX (03 Hex), then waits 4 seconds for the external computer to
respond. If no response is received, one more ETX ( 03 Hex) is sent, the analyzer waits 4
seconds before giving up and gives alarm of communication error.
If the external compute responds ACK, the transmission is done successfully. If the external
computer responds NACK(15 Hex), the analyzer repeat the transmission from step 3. If the
received response from the computer is neither ACK(06 Hex) nor NACK(15 Hex), the
analyzer sends ETX ( 03 Hex) again.
D-4
Appendices
Reserved ###############
Rm #
R1 #
R2 #
R3 #
R4 #
Pm #
Ps #
Pl #
L1 Region ###
L2 Region ###
L3 Region ###
L4 Region ###
L5 Region ###
L6 Region ###
L7 Region ###
L8 Region ###
Reserved ################
WBC Histo (256 channels) ###
RBC Histo (256 channels) ###
PLT Histo (256 channels) ###
Body of the text end
If handshake is enabled [EOT]
If handshake is disabled [EOF]
If handshake is enabled [ETX]
For all the data formats, if the data are marked “*”, then “*” (2A Hex) will be transmitted to the
host.
D-5
Appendices
Figure D-2 L1 to L8
D-6
Appendices
D-7
Appendices
D.4.2 Description
Handshake symbols
During the communication, the two parties acknowledge the communication using
these symbols.
Special symbols
The start and end marks of messages and data fields.
Special delimiter
Delimiter marks between message bodies, data segments and attribute fields
D-8
Appendices
D.4.3 Programming
The analyzer must communicate with the external PC when the Handshake is on in the
following procedure:
When setting up communication connection,The analyzer sends an ENQ (10 Hex), then
waits up to 4 seconds for the external computer to respond with ACK(06 Hex). If the
external computer does not respond, then one more ENQ (10 Hex) will be sent. If it fails
again, the analyzer aborts the transmission and reports a transmission error;
After the ACK(06 Hex) is received, the analyzer then sends data block;
The analyzer sends an ETX(0F Hex), then waits up to 4 seconds for the external
computer to respond with ACK(06 Hex). If the external computer does not respond, then
one more ETX(0F Hex) will be sent. If it fails again, the analyzer aborts the transmission
and reports a transmission error;
D-9
Appendices
Day; 4: Hour)
Dept Department
Tester Tester
Checker Checker
Analysis parameter
Val Parameter value (transmitted per the
default unit)
Low Lower limit of parameters
High Upper limit of parameters
Unit Parameter unit (the unit of which the
default index is 0 is pure text)
Flag Suspect sign
Histogram alarm
Rm Indicates at least two R flags.
R1 Indicates abnormality on the left side of the
lymphocyte hump
R2 Indicates abnormality between the
lymphocyte hump and the mid-sized cell
area.
D-10
Appendices
SD field
FD13
Checker
Lymph# Lymphocyte
The same with those of WBC
count
D-11
Appendices
Gran# Granulocyte
The same with those of WBC
count
Lymph% Lymphocyte
The same with those of WBC
percentage
MCH Mean
The same with those of WBC Corpuscular
Hemoglobin
MCHC Mean
Corpuscular
The same with those of WBC
Hemoglobin
Concentration
RDWCV Red Blood
Cell
Distribution
The same with those of WBC
Width -
Coefficient of
Variation
D-12
Appendices
PDW Platelet
The same with those of WBC Distribution
Width
PCT The same with those of WBC Plateletcrit
AlarmFlag FD1 FD2 FD3 FD4 FD5 FD6 FD7 FD8 Histogram
Rm R1 R2 R3 R4 Pm Ps P1 alarm
D-13
Appendices
Unit Unit
SD field
SD definition of standard QC
SD FD Description
StQCInfo FD1 FD2 FD3 Standard QC
FileNo LotNo ExpDate information
Gran% Granulocyte
The same with those of WBC
percentage
HCT The same with those of WBC Hematocrit
MCV Mean
The same with those of WBC Corpuscular
Volume
MCH Mean
The same with those of WBC Corpuscular
Hemoglobin
MCHC Mean
Corpuscular
The same with those of WBC
Hemoglobin
Concentration
D-14
Appendices
SD field
SD definition of running QC
SD FD Description
RunQCInfo FD1 FD2 FD3 Running QC
FileNo LotNo TestTime information
D-15
Appendices
MCV Mean
The same with those of WBC Corpuscular
Volume
MCH Mean
The same with those of WBC Corpuscular
Hemoglobin
MCHC Mean
Corpuscular
The same with those of WBC
Hemoglobin
Concentration
D-16
Appendices
D.5 Transmission
Enter ”Setup → Settings→ Print & comm.” screen and edit the communication settings as
instructed by Chapter 5.3.2.
D-17
P/N: 2800-20-28882 (10.0)