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BC-20s&BC-30s - Installation Guide - V1.0 - EN PDF
BC-20s&BC-30s - Installation Guide - V1.0 - EN PDF
Warning!
I
Revision History
II
Symbols and Precautions
1. Symbols used in the guide
You may find the following symbols on the analyzer, reagents, controls or calibrators.
Symbol It means...
USB port
III
Network port
ALTERNATING CURRENT
IVD equipment
BATCH CODE
USE BY
SERIAL NUMBER
DATE OF MANUFACTURE
TEMPERATURE LIMITATION
IV
3. Precautions
Be sure to observe the following precautions during installation for the safety of patients
and operators.
WARNING
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.
Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g.
ethanol) around the analyzer. Otherwise, the risk of explosion may exist.
Contacting exposed electronic components while the equipment is attached to
power can cause personal injury from electric shock or damage to electronic
components. Power down before removing covers to access electronic
components.
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.
Possible mechanical movement of the warned position may lead to personal
injury during normal operation, removal and maintenance.
Be sure to dispose of reagents, waste, samples, consumables, etc. according
to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of
V
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.
CAUTION
Improper installation may damage the analyzer. Install the analyzer strictly as
instructed by the installation guide and inspect the analyzer carefully after the
installation.
For problems not mentioned in the installation guide, contact Mindray
customer service department for installation advice.
To prevent personal injury or damage to equipment components, remove
metal jewelry before maintaining or servicing electronic components of the
equipment.
Electrostatic discharge may damage electronic components. If there is a
possibility of ESD damage during installation, then work at an ESD
workstation, or wear an antistatic wrist strap while installing.
NOTE
This equipment must be operated by skilled/trained medical professionals.
VI
Preparations
Table of Contents
Chapter 1 Preparations ...............................................................................................................1
1.1 Purpose .............................................................................................................................1
1.2 Tools ...................................................................................................................................1
1.3 Consumables....................................................................................................................1
1
Preparations
Chapter 1 Preparations
1.1 Purpose
Installation can be performed at the client's according to the procedure in this installation
guide. This guide aims to ensure that the device runs efficiently at the client's.
1.2 Tools
1. Blade or clipper
2. USB
3. Pipette (200ul)
4. Cross-headed screwdriver
1.3 Consumables
1. Plastic test tube
2. Glass pipette
3. Gloves
4. Dust-free tissue
5. Calibrator
6. Control (normal)
1
Unpacking
Ambient
10℃~35℃ -10℃~40℃ 10℃~40℃
Temperature
Atmospheric
70kPa~106kPa 50kPa~106kPa 70kPa~106kPa
pressure
WARNING
Do not place the analyzer in a flammable or explosive environment.
Do not move the analyzer. Contact Mindray or your local distributor if
necessary.
2
Unpacking
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.
NOTE
Make sure all the requirements listed above are met. Otherwise, the
performance of the analyzer might be compromised.
Input
Voltage Frequency
Power
Analyzer (100V-240V~)±10% ≤300VA (50Hz/60Hz)±1Hz
WARNING
Make sure the analyzer is properly grounded.
Only install fuses of specified specification on the analyzer and the pneumatic
unit.
3
Unpacking
Before turning on the analyzer, make sure the input voltage meets the
requirements.
Use the original electrical wire shipped with the analyzer.
4
Unpacking
Chapter 3 Unpacking
3.1 Checking Before Unpacking
Check if the package is intact before unpacking.
5
Unpacking
3. Remove the protection foam from both sides of the main unit, as shown in Figure 3-3.
Protection
foam
6
Unpacking
4. Remove the plastic bag from the main unit. Grab the bottom of the main unit and lift it
onto a countertop. Note that the main unit must be lifted by 1 to 2 persons, as shown in
Figure 3-4.
7
Unpacking
Packing list
Figure 3-5 Packing list
NOTE
When moving the analyzer, do not incline and avoid impact.
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.
8
Connections
Chapter 4 Connections
1. See Figure 4-1 and 4-2 for connections of reagent and waste containers. lyse are
placed inside the left door of the analyzer, diluent and waste container are placed
under the countertop.
9
Connections
NOTE
Remove the plugs of the fluidic connectors on the back of the analyzer.
Make sure the lyse shall be placed on the same level of the analyzer, and the
tube assembly connectors are in good connection.
Make sure the length of the diluent pipe and waste pipe is no more than
1500mm.
The top of the waste container and diluent container must be lower than the
countertop.
2. Connect the pipes according to their order. Open the left door to connect the lyse pipe.
The color of each kind of pipe must be the same, as shown in Figure 4-3 and 4-4.
diluent inlet
Waste outlet
10
Connections
lyse connector
Bottle gap module should be screwed to avoid leak after connecting all reagents. Then
close the left door.
3. Connect the network cable to the network port, as shown in Figure 4-5. The supported
printer models of the USB port are: EPSON LQ-590K, HP Laser Jet P1505n, HP Office Jet
Pro K5300 and HP LaserJet P1606dn.
11
Startup and Setup
1. Place the power switch at the back of the analyzer to the ON position "I" to turn on the
analyzer.
Enter the correct user ID (service) and password (Se s700) into the logon dialog box, as
shown in Figure 5-1.
NOTE
The error messages "Diluent ran out"," lyse ran out" will be displayed as
reagent setup has not been done.
12
Startup and Setup
2. Complete the setup and replacement of "Diluent",and " lyse" using the barcode
scanner or enter the numbers under the barcode when needed.
NOTE
The default setting is recommended.
13
Startup and Setup
14
Other Functions
Print button
15
Other Functions
16
Performance Test
HGB ≤1 g/L
HCT ≤0.5 %
PLT ≤ 5 109 / L
Procedure
1. Tap "Menu”-“Performance"-“Background” to enter the screen shown in Figure 7-1.
17
Performance Test
4. When the test finishes, the analyzer will evaluate the background results and report
Pass or Fail at the bottom of the screen, as Figure 7-3 shows.
5. When test finishes, tap "Export" to export data to an USB, as shown in Figure 7-4.
18
Performance Test
7.2 Reproducibility
Introduction
Test reproducibility of the analyzer with fresh blood or control samples to ensure the
reproducibility is within specified range.
See Table 7-2 for the reproducibility requirements of the analyzer:
Table 7-2 Reproducibility requirements
19
Performance Test
Mid% Mid%≥5%
≤25% ≤25%
WBC≥4.0×109/L
Gran% Gran%≥30%
≤12% ≤12%
WBC≥4.0×109/L
RDW-CV - ≤3.5% ≤3.5%
RDW-SD - ≤3.5% ≤3.5%
MPV - ≤4.0% ≤5.0%
HCT 30~50% - ≤ 2.5
Procedure
Whole blood reproducibility test
1. Tap "Menu”-“Performance"-“Reproducibility” to enter the reproducibility test screen.
See Figure 7-5.
2. Tap the "Mode" button and select reproducibility test mode: whole blood, as shown
in Figure 7-6.
20
Performance Test
3. When control samples are used for the test, enter the lot No. of the control in to the
lot No. box.
4. Press the Aspirate key and test the normal control 10 times in a row, as Figure 7-7
shows.
21
Performance Test
22
Performance Test
1. It is required that the calibrator should be placed under room temperature (18~25)
for 15 minutes after been taken out of refrigerator (2~8), to restore its temperature to
room level.
2. Check if the calibrator is expired, degenerated or infected.
3. Refer to the instructions metioned in the calibrator manual for mixing protocol.
4. Using gauze or soft tissue to absorb the blood possibly splashed out when opening
the cap.
7.3.3Calibration Process
23
Performance Test
2. Follow the operation steps mentioned in chapter 8.3.3 in < Operator's Manual> to
calibrate.
3. To confirm result:
Repeatedly run 10 times, the instrument will automatically calculate the mean
values, SD, CV% of parameters WBC, RBC, HGB, MCV. The system will
automatically estimate if the calibiration process is successful. Save new calibration
factor when successful, if not, please contact service people to check and repair the
instrument and then implement performance verification.
24
Performance Test
2. Follow the operation steps mentioned in chapter 8.3.4 in < Operator's Manual > to
calibrate.
3. To confirm result:
Repeatedly run 10 times, the instrument will automatically calculate the mean
values, SD, CV% of parameters WBC, RBC, HGB, MCV. The system will
automatically estimate if the calibiration process is successful. Save new calibration
factor when successful, if not, please contact service people to check and repair the
instrument and then implement performance verification.
25
Data Management Software
26
Data Management Software
Select the actual analyzer model, the network (TCP/IP) communication parameters are
the same as those of the analyzer. Set up the network IP address according to the Help
system of the data management software (Note: the encoding mode of HL7
communication protocol is UTF-8, and that of 15ID protocol is GBK).
See Figure 8-3 for the communication setup of the analyzer:
27
Data Management Software
28
Data Management Software
29
Installation Checklist
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Installation Checklist
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P/N: 046-007157-00(1.0)