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Model BC-5800/5600
Warning!
1. Reproduction or photocopy of this manual in any manner whatsoever
without the written permission is forbidden.
2. The manufacturer takes no legal obligation to inform the users before
making any change to this guide.
Revision History
2. Symbols on products
You may find the following symbols on the analyzer, reagents, controls or calibrators.
BIOLOGICAL RISK
HIGH VOLTAGE
I
PROTECTIVE EARTH (GROUND)
EARTH (GROUND)
ALTERNATING CURRENT
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
MANUFACTURER
TEMPERATURE LIMITATION
II
3. Precautions
Be sure to observe the following precautions during installation for the safety of patients and
operators.
All the analyzer components and surfaces are potentially infectious, so take
proper protective measures for operation or maintenance.
The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.
III
It is important for the hospital or organization that employs this equipment
to carry out a reasonable installation plan. Neglect of this may result in
machine breakdown or injury of human health.
Connect the analyzer to a socket having sole fuse and protective switch. Do
not use the same fuse and protective switch with other equipment (e.g. life
supporting equipment). Otherwise, the equipment failure, over current or
impulse current that occurs at the startup moment may lead to tripping.
To prevent personal injury during the maintenance, keep your clothes, hairs
and hands from the moving parts, such as sample probe, pincher and
piercer.
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.
IV
Improper installation may damage the analyzer. Install the analyzer strictly
as instructed by the installation guide and inspect the analyzer carefully
after the installation.
V
Table of Contents
1 Preparations.................................................................................................................... 1-1
1.1 Purpose ............................................................................................................... 1-1
1.2 Tools .................................................................................................................... 1-1
1.3 Accessories ......................................................................................................... 1-1
2 Installation Requirements................................................................................................ 2-1
2.1 Space Requirements ........................................................................................... 2-1
2.2 Power Requirements ........................................................................................... 2-1
2.3 Environment Requirements ................................................................................. 2-2
2.4 Confirming the Tube Type on Site ....................................................................... 2-2
3 Package Checking and Unpacking ................................................................................. 3-1
3.1 Checking before unpacking ................................................................................. 3-1
3.2 Unpacking the main unit ...................................................................................... 3-1
3.3 Unpacking the pneumatic unit ............................................................................. 3-3
3.4 Unpacking the accessories.................................................................................. 3-5
3.5 Unpacking the autoloader (optional).................................................................... 3-6
3.6 Packing list check ................................................................................................ 3-8
4 Removal and Installation................................................................................................. 4-1
5 Connections .................................................................................................................... 5-1
6 Start-up............................................................................................................................ 6-1
6.1 Inspection before Startup..................................................................................... 6-1
6.2 Initial start-up ....................................................................................................... 6-1
6.3 Inspection after Startup........................................................................................ 6-5
7 Setup and Adjustment..................................................................................................... 7-1
7.1 Setting Parameters.............................................................................................. 7-2
7.2 Adjusting the HGB blank voltage......................................................................... 7-7
7.3 Adjusting Positions .............................................................................................. 7-8
7.4 Testing Other Functions..................................................................................... 7-19
8 Calibration and Performance Test................................................................................... 8-1
8.1 Background Count............................................................................................... 8-1
8.2 Confirming the Gain of the Optical System ......................................................... 8-1
8.3 Checking the scattergrams.................................................................................. 8-6
8.4 Calibration............................................................................................................ 8-8
8.5 Reproducibility ................................................................................................... 8-11
9 Appendices .....................................................................................................................A-1
A Fluidic diagrams ......................................................................................................A-1
B Method to Identify the Cross Network Cable and the Direct-Connected Network
Cable ...............................................................................................................................B-1
1
1 Preparations
1.1 Purpose
Install the instrument and update the software properly as per the procedures introduced in this
chapter, in order to ensure the safe and effective operation of the analyzer on site.
1.2 Tools
Blade or clipper
Monkey wrench
Pipette (200ul)
Cross-headed screwdriver
1.3 Accessories
Plastic test tube
Glass pipette
7m standard particles
Gloves
Tissues
Calibrator
1-1
2 Installation Requirements
enough room on or below the countertop to accommodate the diluent, rinse and waste
containers.
Make sure all the requirements listed above are met. Otherwise, the
performance of the analyzer might compromise.
WARNING
Make sure the analyzer is properly grounded.
Before turning on the analyzer, make sure the input voltage meets the
requirements.
2-1
Installation Requirements
The environment should be as free as possible from dust, mechanical vibrations, loud
noises and electrical interference;
Do not use this analyzer in close proximity to sources of strong electromagnetic radiation;
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;
WARNING
Do not place the analyzer in a flammable or explosive environment.
Do not move the analyzer or pneumatic unit. Contact Mindray or your local
distributor if necessary.
NOTE
If the ambient temperature is out of the specified operating range, the
analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable.
2-2
3 Package Checking and Unpacking
Binding straps
2. Cut off the binding straps and remove the wooden cover, as shown in Figure 3-2.
3-1
Package Checking and Unpacking
3. Remove the cardboard upward. You can see the main unit protected by foams, as shown in
Figure 3-3.
Accessories of
the main unit
4. Remove the foams on the left and right of the main unit, as shown in Figure 3-4. Then
remove the plastic package and the foam protecting the sample probe shown in Figure 3-5.
Grasp the handles at bottom left and right of the analyzer and move it to the countertop (at
least 2 people are required), as shown in Figure 3-6.
3-2
Package Checking and Unpacking
NOTE
When lifting the main unit, keep it as level as possible and avoid strong
impact. Never lift the autoloader to move the main unit.
Always lift the left and right side of the main unit to move it, as lifting the
front of the analyzer may damage the front cover.
3-3
Package Checking and Unpacking
2. Cut off the binding straps and the adhesive tape. Open the top cover of the pneumatic unit
package, and remove the paper protective corners. Take out the accessory kit of the
pneumatic unit first, as shown in Figure 3-8.
Figure 3-8 Removing the top cover of the pneumatic unit package
3. Firmly grip the two ends of the cardboard and lift the pneumatic unit out of the box. Then
remove the top foam and take out the pneumatic unit, as shown in Figure 3-9.
3-4
Package Checking and Unpacking
NOTE
Do not use the relief valve as a handle to move the pneumatic unit.
2. Cut off the adhesive tape, and take out the waste container, cap assemblies and other
accessories, as shown in Figure 3-11.
3-5
Package Checking and Unpacking
Take out the cardboard, and then the data management software, operator's manual, packing
list, and material kit of the barcode scanner (optional), as shown in Figure 3-12.
Figure 3-12 Taking out the data management software and the operator's manual
3-6
Package Checking and Unpacking
2. Cut off the binding straps and the adhesive tape. Open the top cover of the package and
remove the protective cardboard. Take out the tube racks as shown in Figure 3-14.
3. Hold the foams on both sides of the autoloader to lift it out of the box. Then remove the
foams to take out the autoloader and the stop bars, as shown in Figure 3-15.
3-7
Package Checking and Unpacking
NOTE
If any inconformity between the delivered parts and items on the packing list
is found, contact Mindray Customer Service department or you local
distributor.
3-8
4 Removal and Installation
Removing the fixing bolts and their sleeves at the bottom of the pneumatic unit
To protect the air pump from damage during transportation, the pump is fixed by four bolts at
the bottom of the pneumatic unit. Before using the pneumatic unit, place the pneumatic unit at
the edge of the countertop to remove the bolts.
Figure 4-1 Removing the fixing bolts and sleeves at the bottom of the pneumatic unit
Use a monkey wrench to loosen one of the four bolts (as shown in Figure 4-1 (a)); Use a
cross-head screwdriver to loosen the two M3X8 screws on the bracket that fixes the bolt (as
shown in Figure 4-1 (b)); move the bracket, and then remove the bolt with its sleeve (as
shown in Figure 4-1 (c)). Re-fix the bracket. Repeat the steps above to remove the other
three bolts.
Removing the adhesive tapes fixing the stop bar of the front cover
Open the front cover, and then remove the adhesive tapes fixing the stop bar shown in Figure
4-2.
Adhesive
tapes
Figure 4-2 The adhesive tape fixing the stop bar of the front cover
4-1
Removal and Installation
Open the front cover, and then use diagonal pliers or scissors to cut off the plastic cable tie
fixing the wipe block, as shown in Figure 4-3.
Removing the plastic cable ties fixing the cylinder and the tube pincher
Open the front cover, and then you can see the plastic cable ties fixing the cylinder and the
tube pincher next the sample mixing assembly. Use a pair of scissors to cut off the plastic
cable ties, as shown in Figure 4-4.
Plastic
cable tie
Figure 4-4 Plastic cable ties fixing the cylinder and the tube pincher
Removing the adhesive tapes fixing the communication cables of the autoloader
To facilitate the connection with the autoloader, remove the adhesive tapes to fix the
communication cables of the autoloader at the lower part of the front cover, as shown in Figure
4-5.
4-2
Removal and Installation
Adhesive tapes
Figure 4-5 Adhesive tapes fixing the communication cables of the autoloader
Removing the adhesive tape and plastic cable ties on the autoloader
Remove the adhesive tape on the autoloader and cut off the plastic cable ties fixing the
accumulation tray and the stop bars of the autoloader, as shown in Figure 4-6.
Figure 4-6 Removing the adhesive tape and plastic cable ties
Removing the plastic cable tie that fixes the longitudinal feeding pusher
Cut off the plastic cable tie fixing the longitudinal feeding pusher, as shown in Figure 4-7.
4-3
Removal and Installation
Figure 4-7 Plastic cable tie fixing the longitudinal feeding pusher
4-4
5 Connections
Installing the autoloader (optional)
5-1
Connections
Note: The
communication cable of
the autoloader cannot be
pressed against the
lower cover of the main
unit or against the
enclosure of the
autoloader. Otherwise,
short-circuit will occur to
burn the chip of the
driver board.
The cable is first led through this hole, then along the edge of the
sample transport unit, and finally inserted to the adapter plate.
Figure 5-2 Installing the communication cable
If the hospital uses the 1475 (mm) or 1575 (mm) tubes, remove the adapter from the tube
rack before loading the tubes, as shown in Figure 5-4.
5-2
Connections
See Figure 5-5 for connections of reagents and the waste container. Note that the M-58LEO(I)
lyse, M-58LEO(II) lyse, M-58LH lyse and M-58LBA lyse are placed on the same level as the
analyzer; the M-58D diluent, M-58 cleanser, and waste container should be placed under the
countertop where the analyzer is placed; a supporting board for the diluent container shall be
installed as instructed by the operator's manual; as shown in Figure 5-7. Make sure none of
the tubes are pressed or bent.
5-3
Connections
NOTE
Make sure the M-53LEO (I) lyse, M-53LEO (II) lyse, M-53LH lyse and M-53
cleanser are placed on the same level as the analyzer.
Figure 5-7 Installing the supporting board for the diluent container
5-4
Connections
See Figure 5-8 for connections between the analyzer and the pneumatic unit.
Ensure proper and reliable connections.
Figure 5-8 Connections between the analyzer and the pneumatic unit
See Figure 5-9 for connections between the analyzer and the optional equipments.
Ensure proper and reliable connections.
5-5
Connections
Be sure to use the cross network cable to connect the analyzer and the PC.
Connect the main unit and the pneumatic unit to their specified power outlets. Pay attention
that the power requirements of the main unit are not totally the same to those of the pneumatic
unit. Be sure they are connected to the right power outlets.
5-6
6 Start-up
6-1
Start-up
on the pneumatic unit first and then the main unit, switch on the main unit by pressing the
power button on the front cover.
Since the fluidic system of the analyzer has been drained before delivery, the fluidics
initialization procedure runs automatically at the initial startup to prime the fluidics. This
process takes about 20 minutes. During the startup, a login dialog box will pop up after the
self-test and the fluidics initialization.
Enter the service engineer ID "Service" and password "Se s700" (note: there is a space
between "e" and "s") in the box to enter the main screen, as shown in Figure 6-3.
If error occurs during startup, the analyzer will not run the fluidics initialization, and a dialog box
shown in Figure 6-4 below will pop up.
6-2
Start-up
Click "No", and then go to the "Count" screen to check the error report, as shown in Figure 6-5.
Perform the troubleshooting procedures, and then click "Remove Error". The initialization runs
automatically and lasts for about 15 minutes.
6-3
Start-up
After entering the "Main" screen (shown in Figure 6-3), click the "Setup" icon to go to the
screen shown in Figure 6-6.
After entering the "Setup" screen, click "Advanced" button to go to the advanced setup screen
shown in Figure 6-7.
6-4
Start-up
In the advanced setup screen, select "Laser Diode Test temp." to activate the laser diode
temperature detecting function. For the autoloading model, select "Barcode configured" (if the
barcode scanner is configured) and "Sensor configured" (select as required by the customer)
to activate the barcode scan and blood volume detecting functions.
Check whether the version of the installation CD is the latest. If not, consider whether it is
necessary to update it.
Click "Vol. & Cur." to enter the voltage and current screen. Check if all the values at this screen
are within the predefined normal ranges. If not, perform troubleshooting according to relevant
6-5
Start-up
sections in the service manual until all the values are within corresponding normal ranges, as
shown in Figure 6-9.
Click the "Temp & Pres" button at the "Status" screen to enter the screen shown in Figure 7-9.
Check if all the values at this screen are within the predefined normal ranges. If not, adjust the
pressure/vacuum regulators to make the pressure values fall within corresponding ranges. For
how to adjust the temperature and pressure, see "Adjusting pressure and temperature" in
Section 7.1 "Setting Parameters".
6-6
7 Setup and Adjustment
Selecting reminder of
the predilute mode
Setting reagent-related
information
Adjusting the
temperature and
pressure
Adjusting the
autoloading positions
7-1
Setup and Adjustment
You can customize the date, time and the date format of the analyzer. The date and time at the
screen and the printout will change if the settings are changed.
The "Date/Time" screen is the default screen after you click the "Setup" button. If the current
screen is not the "Date/Time" screen, click the "Date/Time" button to enter the "Date/Time"
screen shown in Figure 7-2.
Enter the current date and time in the date field and time field respectively.
If the year entered is out of the range of 2000 2036, a dialog box shown in Figure 7-3 will pop
up when you try to exit the date/time setup screen. Click "OK" to close the dialog box. Change
the date into a valid one.
7-2
Setup and Adjustment
There are three date formats available: "YYYY-MM-DD", "MM-DD-YYYY" and "DD-MM-YYYY".
To select the desired format, click the corresponding radio button.
At the "Setup" screen, click the "Assistant" button to enter the screen shown in Figure 7-4.
If you have activated the reminder and selected the predilute mode, a dialog box will pop up
when the sample will be analyzed in the predilute mode. Click the "OK" button to proceed with
the analysis or click the "Cancel" button to exit.
To activate the reminder, click the "Prompt" radio button. To deactivate the reminder, click the
"No prompt" radio button. The default setting is "Prompt". The default setting is "Prompt".
7-3
Setup and Adjustment
Two ID setup methods for new samples are provided for the open-vial sampling mode.
If "Auto increment" is selected, when there is a new sample to be run, the next ID increases by
1 based on the current ID; if "Manual entry" is selected, when there is a new sample to be run,
the default next ID is empty; as shown in Figure 7-4.
For bi-directional LIS mode, the "Entry of next sample ID" is set to "Manual
entry" and cannot be changed.
Disable the blood sensor when running samples with extreme low
concentrations, for example, samples of dialysis patients.
Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.
You can set the expiration date of the diluent, LEO (I) lyse, LEO (II) lyse, LBA lyse, LH lyse and
cleanser at the "Reagent" screen.
At the "Setup" screen, click the "Reagent" button to enter the screen shown in Figure 7-6.
7-4
Setup and Adjustment
Click the box of the desired reagent and enter the expiration date.
If the year entered is out of the range of 20002036, a dialog box shown in Figure 7-7 will pop
up when you try to exit the reagent setup screen. Click "OK" to close the dialog box. Change
the date into a valid one.
If an external barcode scanner is connected, you can click the "Barcode scanner" check box
shown in Figure 7-8 to enable it. Scan the barcode with the external barcode scanner. If you
hear a beep, it means the entry is finished. The expiration date of reagents will appear in the
corresponding boxes.
7-5
Setup and Adjustment
For any reagent, the entered expiration date should be either the expiration
date printed on the labeling or the open-container expiration date,
whichever is earlier. The open-container expiration date is calculated as
follows: the date that container is opened + the open-container stability
days.
Click "Service" at the main screen to go to the "Service" screen. Click "Status" "Temp &
Pres", and then check if all the values at this screen are within the predefined normal ranges,
as shown in Figure 7-9. If not, adjust the pressure/vacuum regulators to make the pressure
values fall within corresponding ranges. See the next step for how to make adjustment.
7-6
Setup and Adjustment
Adjust PS1 to PS4 in turn. Wait 10-15 seconds for the values to stop changing after adjustment.
Check if the P5 value is within the normal range (as shown in
Figure 7-10). Tighten the pressure/vacuum regulators after you finish adjusting and make sure
all the values are still within corresponding normal ranges.
7-7
Setup and Adjustment
factory setting. In this case, you can adjust the HGB blank voltage through gain setup.
7-8
Setup and Adjustment
2. Pull down the wipe block to make it apart from the sample probe. Check if the probe aims
right at the hole in the wipe block. If not, loosen the four screws shown in Figure 7-14 to make
adjustment.
7-9
Setup and Adjustment
Loosen these four socket cap screws to adjust the height of the wipe block
Figure 7-14 Adjusting the positions of the wipe block and the sample probe
3. Check if the belt is properly strained and there is no strident noise while the wipe block is
moving.
7-10
Setup and Adjustment
Check if the front and back of the tube rack distance adjusting fitting is close to the front and
back supporting boards. If the fitting is too far away from either supporting board or unable to
get through, remove the 2 screws fixing the front supporting board to adjust the distance.
7-11
Setup and Adjustment
On the mix unit debugging screen, click "Initialization" in the "Manipulator" area to initialize the
manipulator; then click "Initialization" in the "Autoloader" area to initialize the autoloader. Note:
if the buttons gray out, click the "Open compressor" button. After the compressor is open, the
buttons will be activated.
Place an empty tube rack onto the autoloader load platform, and click the "Load" button in the
"Autoloader" area. When the tube rack comes to the loading position, click the "Feed" button 3
to 4 times to load the tube until it comes to the pinching position. Note: Do not click the "Feed"
button before the former movement is done.
Click the "Pinch cylndr fwd" button in the "Manipulater" area to move the manipulator to the
pinching position and place the alignment fixture into the pincher (with the bottom of the fixture
fully covering the upper surface of the tube rack).
7-12
Setup and Adjustment
Adjust the position of the autoloader so that the center of the tube position coincides with that
of the fixture.
a) Right-and-left adjustment: move the autoloader left and right until the center of the tube
position coincides with that of the fixture, and then tighten the two screws fixing the autoloader
(as shown in Figure 5-3). Check after the adjustment and then remove the fixture.
b) Fore-and-aft adjustment (this step is for reference in manufacture): Do the following before
installing the lower cover. Loosen the four screws shown in Figure 7-19 to move the mix unit
forward and backward until the center of the tube position coincides with that of the fixture (as
shown in Figure 7-18) and then tighten the four screws.
c) Verification: remove the fixture, click the "Pinch cylndr bkwd" button in the "Manipulater"
area to reposition the manipulator and then place the fixture into the tube position (as shown in
Figure 7-20); Verify the autoloader position as per the following steps:
7-13
Setup and Adjustment
Click the "Pinch cylndr fwd" button to pinch the fixture (as shown in Figure 7-21), and then click
the "Elvt cylndr up" button to remove the fixture out of the rack. Click the "Elvt cylndr down"
button to place the fixture back into the rack, and then click the "Pinch cylndr bkwd" button to
reposition the pincher. Repeat these steps 3 to 5 times to confirm that the fixture can be placed
in the rack smoothly. Otherwise, repeat steps a) and b) until it passes the inspection.
Click the "Feed" and "Unload" buttons to remove the rack and the adjustment of the autoloader
position is completed.
7-14
Setup and Adjustment
After the adjustment, fix the autoloader cover to the front cover by 2 screws, as Figure 7-22
shows.
2. Click the "Initialization" button in the "Mix motor", and "Initialization" and "Pinch cylndr
bkwd" buttons in the "Manipulator" area. Check if the position of the pincher arm is 1mm from
7-15
Setup and Adjustment
the connecting pedestal, as shown in Figure 7-24. If not, adjust its position.
3. Click "Mix" and check if the distance between the top of the pincher and the wipe block is
28mm, as shown in Figure 7-25. If not, loosen the corresponding screws to make adjustment.
4. Use a gummed paper to envelop the opening of a standard test tube and place the tube
into the rack. When the tube is placed back after sampling, check the position of the piercing
hole to determine if the tube and the piercing needle are coaxial. If not, make adjustment as
per Figure 7-26 until they become coaxial.
7-16
Setup and Adjustment
Loosen these five screws to adjust the position of the test tube
relative to the locating axis and piercing hole central axis.
5. Place a standard tube in the tube rack, and click "Sample&Mix&pierce". Check if the
distance between the probe wipe pedestal and the probe fixing pedestal is 1-2mm; if not,
adjust the stroke of the pierce cylinder by tuning the cylinder stroke adjusting knob and then
secure the cylinder stroke fixing ring, as shown in Figure 7-27.
For analyzers equipped with autoloaders, click the "Initialization", "Load", "Feed" and "Unfeed"
buttons in the "Autoloader" area in turn to check if the unit moves properly, as shown in Figure
7-28.
7-17
Setup and Adjustment
Click "Service""Self-test""Valve" to enter the screen shown in Figure 7-29. Click the "Test
all" button to check if all the valves are functioning properly (the valves make clicking sounds if
they function well).
7-18
Setup and Adjustment
Click "Service""Self-test""Dobber" to enter the screen shown in Figure 7-30. Check the
dobbers in turn to see whether they are functioning properly or need to be repaired or
replaced.
Network connection
Connect the analyzer and the PC with a network cable, and check if the corresponding icon
shows that they are successfully connected.
Data communication
Go to the "Review" screen and choose the table review or graph review. Select the sample
results you need and perform transmission.
Printing
Go to the "Review" screen and choose the graph review. Select results with sample data and
graphs to print, and the printer shall print out all these data and graphs in a clear and correct
way.
7-19
8 Calibration and Performance Test
Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.
8-1
Calibration and Performance Test
"LAS CG Position" and "MAS CG Position" of the 3 analyses, and make sure the following
requirements are met: LAS CG position mean within 2.80 from the target; MAS CG position
mean within 3.20 from the target. Record the mean values, as shown in Figure 8-2.
If the mean values is out of the range, enter the "LAS CG Target" and "MAS CG Target" and
click ">>>" to get the gain values. Click "Gain setup" to apply the calculated gain values, as
shown in Figure 8-3.
8-2
Calibration and Performance Test
Configure gain setup of the other 2 analyses in the same way, and record the gain values.
Calculate the mean values of the LAS gain and MAS gain of the 3 analyses as the final gains.
Click "Setup""Gain", and enter the final gains in the "WBC_LAS(DIFF)" and
"WBC_MAS(DIFF)" fields, as shown in Figure 8-4. In the "Corresponding Factor of DIFF and
BASO" area, enter 1.87 in the LAS field and 1.48 in the MAS field.
Run the calibrator again, and check if the following requirements are met: LAS CG position
within 2.00 from the target; MAS CG position within 2.00 from the target.
Perform the optical gain confirmation with the CBC-5DMR control only when
the specified calibrator is not available.
At the "Count" screen, select the mode "OV-WB" and "CBC+5DIFF", and then run the
specified control three times. Select the first analysis record of the control, and click
"OpAdjust". Select "Control" mode and click "Calculate". Record the "LAS CG Position" and
"MAS CG Position" of the particle with larger "LAS 0.1max Number", and then check the "LAS
CG Position" and "MAS CG Position" of the other 2 analyses. Calculate the mean values of the
"LAS CG Position" and "MAS CG Position" of the 3 analyses, and make sure the following
requirements are met: LAS CG position mean within 2.80 from the target; MAS CG position
8-3
Calibration and Performance Test
mean within 3.20 from the target. Record the mean values, as shown in Figure 8-5.
If the mean values is out of the range, enter the "LAS CG Target" and "MAS CG Target" and
click ">>>" to get the gain values. Click "Gain setup" to apply the calculated gain values, as
shown in Figure 8-6.
8-4
Calibration and Performance Test
Configure gain setup of the other 2 analyses in the same way, and record the gain values.
Calculate the mean values of the LAS gain and MAS gain of the 3 analyses as the final gains.
Click "Setup""Gain", and enter the final gains in the "WBC_LAS(DIFF)" and
"WBC_MAS(DIFF)" fields, as shown in Figure 8-7. In the "Corresponding Factor of DIFF and
BASO" area, enter 1.87 in the LAS field and 1.48 in the MAS field.
Run the control again, and check if the following requirements are met: LAS CG position within
2.00 from the target; MAS CG position within 2.00 from the target.
8-5
Calibration and Performance Test
No larger than 9
No larger than 13
Go to the gain setup screen, and enter the gain value you've just recorded in the
WBC_MAS(DIFF) field.
Scattergrams of the selected samples shall be in normal status (all the sub-populations are
well separated from each other, and each of them is well aggregated), as shown in Figure 1;
the scattergram is not qualified if the sub-populations are not well separated from each other,
not well aggregated, too loose in a general view, or have too many unidentified spots, as
shown in Figure 2; samples which is clearly mis-differentiated by the algorithm are not qualified,
as shown in Figure 3;
8-6
Calibration and Performance Test
8-7
Calibration and Performance Test
8.4 Calibration
Both the specified calibrator and fresh blood samples can be used for calibration.
OV-WB calibration
Go to the "Calibration" screen, click "Calibrator" and select "OV-WB" mode (as shown in Figure
8-10). Enter the lot No., expiration date and assigned values (into the "Mean" fields) of the
calibrator. Run the calibrator in the open-vial module and perform auto calibration.
The CV values and the new calibration factors calculated by the system are displayed at the
bottom of the table. The calibration factors shall be 75%-125% of the assigned values, and the
CV values shall meet the specifications.
OV-PD calibration
Select the "OV-PD" mode (as shown in Figure 8-11), and enter the assigned values (into the
"Mean" fields) of the calibration. Click "Diluent" to get ready to dispense diluent.
8-8
Calibration and Performance Test
Present a centrifugal tube to the sample probe. Press the aspirate key to dispense 120ul of
diluent into the tube. Repeat this procedure until you get 600ul diluent.
Add 200ul of specified calibrator by pipette into the tube of diluent and shake the tube to mix
the sample. Present the well mixed sample to the sample probe and press the aspirate key.
The analyzer will perform the auto calibration.
The CV values and the new calibration factors calculated by the system are displayed at the
bottom of the table. The calibration factors shall be 75%-125% of the assigned values, and the
CV values shall meet the specifications.
If the analyzer is equipped with an autoloader (optional), select the "AL-WB" mode (as shown
in Figure 8-12), and enter the lot number, expiration date and assigned values (into the "Mean"
fields) of the specified calibrator.
8-9
Calibration and Performance Test
Place a vial of specified calibrator in the tube rack. Run the calibrator in the AL-WB mode and
OV-WB mode, no less than 3 times for each mode.
The CV values, the new calibration factors calculated by the system, and the factory
correlation coefficients are displayed at the bottom of the table. The calibration factors shall be
75%-125% of the assigned values, and the CV values shall meet the specifications.
8-10
Calibration and Performance Test
In the "Mean" fields, enter the analyses results of the blood sample on the instrument (which
shall be in good condition) specified by the customer. After the calibration in the whole blood
mode, run a blood sample consecutively for 3 times in the WB-CBC+5DIFF mode, and then
use the mean values of the 3 analyses as the targets (rounded up to 2 decimal digits) for the
following calibration in the predilute mode.
After the calibration with fresh blood samples, run 5 vials of sample consecutively for 3 times in
the AL-WB-CBC+5DIFF mode, OV-WB-CBC+5DIFF mode and OV-PD-CBC+5DIFF mode
respectively. Then check and make sure the mean values of the analyses are within the limits
from the assigned values (as specified for the batch of calibrator)
Note: Perform the calibration either with the calibrator or fresh blood samples, unless required
by the customer.
8.5 Reproducibility
It is necessary to perform the reproducibility test to delivered analyzers for reliable
performance. Do as follows:
Enter the "Count" screen and run a vial of specified normal-level control consecutively for 10
times in the OV-WB-CBC+5DIFF mode and AL-WB-CBC+5DIFF mode respectively.
Enter the "Review" screen to check the reproducibility of the 1-10 runs. Click the "CV" button to
check if the CV values meet the following requirements (shown in Figure 8-15), as shown in
Figure 8-14.
8-11
Calibration and Performance Test
If fresh blood samples (see the Operator's Manual for detailed specifications) can be attained,
perform the OV-WB-CBC+5DIFF reproducibility test in the WB-CBC+5DIFF mode, and then
record the CV values of WBC, RBC, HGB, MCV and PLT.
8-12
9 Appendices
A Fluidic diagrams
A-1
Appendices
A-2
B Method to Identify the Cross Network Cable and the
Direct-Connected Network Cable
2. Define one end of the cable to be A randomly. Then, the other end is B. The way to connect
the end A and B is shown in Figure B-2.
End A: white and green, green, white and orange, blue, white and blue, orange, white and
brown, and brown (1 and 3 is exchanged; 2 and 6 is exchanged)
End B: white and orange, orange, white and green, blue, white and blue, green, white and
brown, and brown
B-1
Appendices
2. Define one end of the cable to be A randomly. Then, the other end is B. The way to connect
the end A and B is shown in Figure B-4.
End A: white and orange, orange, white and green, blue, white and blue, green, white and
brown, and brown
End B: white and orange, orange, white and green, blue, white and blue, green, white and
brown, and brown
B-2
P/N: 046-000685-001.0