BC-5000 BC-5150 INSTALLATION GUIDE

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.

I
 Revision History

Versi Date of Cause of Revision Page No. SER. Come into

on Revision
No.
(month/year /Revised by Revision Details No. Effect on
)

II
Symbols and Precautions
1. Symbols used in the guide

You will find the following cautionary symbols in this guide:

Symbol It means...
Read the statement below the symbol. The statement
WARNING is alerting you to an operating hazard that can cause
personnel injury.
Read the statement below the symbol. The statement
CAUTION is alerting you to a possibility of analyzer damage or
unreliable analysis results.
Read the statement below the symbol. The statement
NOTE is alerting you to information that requires your
attention.

Read the statement below the symbol. The statement

is alerting you to a potentially biohazardous condition.

2. Indication of Safety Symbols

You may find the following symbols on the analyzer, reagents, controls or calibrators.

Symbol It means...

CAUTION, CONSULT ACCOMPANYING

DOCUMENTS.
Note: Users are recommended to consult
accompanying documents to obtain
important safety information.
Biohazard

WARNING, LASER BEAM

PROTECTIVE EARTH (GROUND)

USB port

III
 Network port

ALTERNATING CURRENT

IVD equipment

BATCH CODE

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

EXERCISE CAUTION WHEN

WORKING AROUND TO AVIOD
PRICKING
Manufacturer

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

THE DEVICE IS FULLY

CONFORMANCE WITH THE COUNCIL
DIRECTIVE CONCERNING IN VITRO
DIAGNOSTIC MEDICAL DEVICES
98/79/EC.

IV
3. Precautions

Be sure to observe the following precautions during installation for the safety of patients
and operators.

 Samples, controls, calibrators and waste are potentially infectious. Wear

proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.
 All the analyzer components and surfaces are potentially infectious, so take
proper protective measures for operation and maintenance.
 The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

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

Chapter 2 Installation Requirements ......................................................................................2

2.1 Operating Environment ...................................................................................................2
2.2 Space Requirements .......................................................................................................3
2.3 Power Requirements .......................................................................................................3
2.4 Confirming the Tube Type on Site .................................................................................4

Chapter 3 Unpacking ...................................................................................................................5

3.1 Checking Before Unpacking...........................................................................................5
3.2 Unpacking the Main Unit.................................................................................................5
3.3 Checking Packing List .....................................................................................................7

Chapter 4 Connections ...............................................................................................................8

Chapter 5 Startup and Setup ...................................................................................................12

5.1 Initial start-up ..................................................................................................................12
5.2 Reagent Setup ...............................................................................................................12
5.3 Maintenance Setup ........................................................................................................13

Chapter 6 Other Functions ......................................................................................................15

6.1 Print ..................................................................................................................................15
6.2 External Barcode Scanner ...........................................................................................15

Chapter 7 Performance Test ....................................................................................................17

7.1 Background Verification ................................................................................................17
7.2 Repeatability ...................................................................................................................20

Chapter 8 Data Management Software .................................................................................24

Chapter 9 Installation Checklist .............................................................................................28

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)

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 Unpacking

Chapter 2 Installation Requirements

2.1 Operating Environment
Make sure the operating environment of the analyzer meets the requirements in Table
2-1before installation.

Table 2-1 Environment Requirements

Operating Storage Running

Environment Environment Environment
Requirements Requirements Requirements

Ambient
10℃～30℃ -10℃～40℃ 10℃～40℃
Temperature

Relative Humidity 20%～85% 10%～90% 10%～90%

Atmospheric
70kPa～106kPa 50kPa～106kPa 70kPa～106kPa
pressure

Besides, the installation environment must meet the requirements below:

a. The environment should be as free as possible from dust, mechanical vibrations,
and electrical interference;
b. It is advisable to evaluate the electromagnetic environment prior to the operation of
this analyzer. Make sure the electromagnetic interference is less than CLASS B. Do
not use this analyzer in close proximity to sources of strong electromagnetic
radiation;
c. Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close;
d. Do not place the analyzer on a slope;
e. Do not place the analyzer in direct sunlight or in front of a source of heat or drafts;
f. The environment shall be well ventilated.

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.

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 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.

2.2 Space Requirements

Check the site for proper space allocation. In addition to the space required for the
analyzer itself, arrange for:
a. at least 50 cm to both left and right sides;
b. at least 20 cm behind the analyzer;
c. enough room on or below the countertop to accommodate the diluent, lyse and
waste containers.
d. Diluent shall be placed within 1 meter height under the analyzer, and lyse is
placed inside the analyzer.
e. The countertop (or the floor) that accommodates the analyzer system shall be
able to withstand a weight of at least 40Kg.

NOTE
 Make sure all the requirements listed above are met. Otherwise, the
performance of the analyzer might be compromised.

2.3 Power Requirements

See Table 2-2 for the power requirements of the analyzer. Power specification must be
checked carefully before installation.

Table 2-2 Power Requirements

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.

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 Unpacking

 Before turning on the analyzer, make sure the input voltage meets the
requirements.
 Use the original electrical wire shipped with the analyzer.

2.4 Confirming the Tube Type on Site

The following tubes can be used:
Evacuated collection tube, Ф12～15×75mm (without cap), for whole blood mode;
Centrifugal tube, Ф11×40mm(1.5ml) and0.5ml, for predilute and capillary whole
blood mode.
Closed small anticoagulated tube, Ф10.7×42mm(without cap),(No. 365974 of BD),
0.5ml, can be used in open vial tests, for capillary whole blood mode.
Note: the height of the evacuated collection tube must be no more than 83mm (with
cap).

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 Unpacking

Chapter 3 Unpacking
3.1 Checking Before Unpacking
Check if the package is intact before unpacking.

3.2 Unpacking the Main Unit

1. The appearance of the main unit is shown in Figure 3-1. Cut off the binding straps
before unpacking.

Figure 3-1 Exterior package of the main unit

2. Cut off the binding straps and remove the wooden cover. Then, remove the accessory
box shown in Figure 3-2.

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 Unpacking

Figure 3-2 Taking off the accessory package

4. Remove the protection foam from both sides of the main unit, as shown in Figure 3-3.

Protection
foam

Figure 3-3 Remove the protection foam

5. 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

6
 Unpacking

Figure 3-4.

Figure 3-4 Lifting the main unit

3.3 Checking Packing List

Check the delivered components against the packing list to see if everything is delivered.
SeeFigure 3-5.

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.

7
 Connections

Chapter 4 Connections
1. SeeFigure 4-1 and 4-2 for connections of reagent and waste containers. M-52
DIFF lyse and M-52 LH lyse are placed inside the left door of the analyzer, M-52D
diluent and waste container are placed under the countertop.

Figure4-1 Back of the analyzer, reagent and waste connection

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 Connections

Figure 4-2 Left of the analyzer, lyse connection

NOTE
 Remove the plugs of the fluidic connectors on the back of the analyzer.
 Make sure the M-52DIFF lyse and M-52 LH lyse shall be placed on the same
level of the analyzer, and the tube assembly connectors are in good connection.
 Install a supporting board on the cap assembly of the M-52D diluent container,
as shown inFigure 4-3.
 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. Install the supporting board to the diluent container cap, as shown in Figure 4-3.

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 Connections

Install
supporting board

Figure 4-3 Install the supporting board

3. 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 4-4 and 4-5.

M-52D
diluent inlet

Figure 4-4Properly connected wires and lines

Waste outlet Waste sensor connector Power socket

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 Connections

M-52DIFF lyse connector

M-52LH lyse connector

Figure 4-5Properly connected wires and lines

Close the left door after connecting all reagents.

4. Connect the network cable to the network port, as shown inFigure 4-6. The supported
printer models of the USB port are: EPSON LQ-590K, HP Laser Jet P1505n, HP OfficeJet
Pro K5300 and HP LaserJet P1606dn.

Figure 4-6 USB port and network port

11
 Startup and Setup

Chapter 5 Startup and Setup

5.1 Initial start-up
Start up the analyzer:

1. Place the power switch at the back of the analyzer to the ON position "I" to turn on the
analyzer.

2. Make sure the indicator is on.

3. The analyzer will perform self-test and initialization.

Enter the correct user name (service) and password (Se s700) into the logon dialog box,
as shown in Figure 5-1.

Figure 5-1 Logon

NOTE
 The error messages "Diluent ran out", "DIFF lyse ran out" and "LH lyse ran
out" will be displayed as reagent setup has not been done.

5.2 Reagent Setup

1. Tap the "Reagent Setup" button to enter the screen shown in Figure 5-2.

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 Startup and Setup

Tap this button

Figure 5-2 Reagent Setup

2. Complete the setup and replacement of "Diluent", "DIFF lyse" and "LH lyse"
using the barcode scanner when needed.

5.3 Maintenance Setup

1. Click "Setup" - "Maintenance Setup" in the system menu.
2. Set up the waiting time before entering standby mode automatically, which
means for how long the analyzer stays inactive, it will enter the standby
mode automatically.
3. Set up the probe cleanser maintenance time by editing the time in the
"Time-based daily maintenance" edit box. See Figure 5-3.

NOTE
 The default setting is recommended.

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 Startup and Setup

Figure 5-3 Maintenance Setup

14
 Other Functions

Chapter 6 Other Functions

6.1 Print
Tap "Setup" - "System Setup" - "Print Setup" to enter the print screen. The print button is
activated, which means printer has been connected successfully and reports can be
printer, as shown in Figure 6-1.

Print button

Figure 6-1 Print setup screen

6.2 External Barcode Scanner

If the customer requires an external barcode scanner, plug the connector of the scanner
into the USB port on the left of the analyzer, as shown in Figure 6-2. The scanner can be
used to scan reagent barcodes and sample ID barcodes.

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 Other Functions

Figure 6-2 Connecting the external scanner

To scan reagent barcode, point the scanner to the barcode, and make sure the infrared
ray of the scanner covers the range of the barcode. The message "Barcode loading
succeeded." will be displayed as shown in Figure 6-3.

Figure 6-3 Loading reagent barcode

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 Performance Test

Chapter 7 Performance Test

7.1 Background Verification
 Introduction
Test the background results of the analyzer; make sure the results meet the
requirement of the analyzer specification. Note: use diluent for background test.
The specification requirements are as follows:

Table 7-1 Background/blank count requirement

Parameter Background/ blank count requirements

WBC ≤ 0.20 109 / L

RBC ≤ 0.02 1012/ L

HGB ≤1 g/L

HCT ≤0.5 %

PLT ≤ 10  109 / L

 Procedure
1. Tap "Performance"-“Background” to enter the screen shown in Figure 7-1.

Figure 7-1 Enter the "Background" screen

17
 Performance Test

2. Tap the "Mode" button to select blood sample mode, as shown in Figure 7-2;

Figure 7-2 Select background test mode

3. Run diluent 3 times in a row on the analyzer, the highest result of the 3 tests is
taken as the blank count result.

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.

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 Performance Test

Figure 7-3 Calculate "Background" test result

5. When test finishes, tap "Export" to export data to an USB, as shown in Figure 7-4.

Figure 7-4 Export test results

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 Performance Test

7.2 Repeatability
 Introduction
Test repeatability of the analyzer with fresh blood or control samples to ensure
the repeatability is within specified range.
See Table 7-2 for the repeatability requirements of the analyzer:
Table 7-2 Repeatability requirements

Parameter Range Whole blood Predilute sample

sample repeatability
repeatability (CV/Absolute
(CV/Absolute deviation d)
deviation d)
9 9
WBC 4.00×10 /L～15.00 10 / L ≤2.0% ≤4.0%
Neu% 50.0%～70.0% ±4.0(d) ±8.0(d)
Lym% 20.0%～40.0% ±3.0(d) ±6.0(d)
Mon% 5.0%～10.0% ±2.0(d) ±4.0(d)
Eos% 2.0%～5.0% ±1.5(d) ±2.5(d)
Bas% 0.5%～1.5% ±0.8(d) ±1.2(d)
12 12
3.50  10 / L ~ 6.00  10 / ≤1.5% ≤3.0%
RBC
L
HGB 110 g/L ~ 180 g/L ≤1.5% ≤3.0%
MCV 70 fL～120 fL ≤1.0% ≤2.0%
RDW-CV / ≤1.5% /
RDW-SD / ≤1.5% /
100  109 / L ~ 149  109 / L ≤6.0% ≤10.0%
PLT 9 9
150  10 / L ~ 500  10 / L ≤4.0% ≤8.0%
MPV / ≤4.0% ≤8.0%
PDW / ≤4.0% /

 Procedure
 Whole blood repeatability test
1. Tap "Performance"-“Repeatability” to enter the repeatability test screen. See Figure
7-5.

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 Performance Test

Figure 7-5 Repeatability test

2. Tap the "Mode" button and select repeatability test mode: whole blood CBC+DIFF,
as shown in Figure 7-6.

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 Performance Test

Figure 7-6 Select mode

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 for 5-DIFF analyzers 10 times in
a row, as Figure 7-7 shows.

Figure 7-7 Press the aspirate key

5. Select test data when the test finishes, the Pass or Fail result will be displayed at
the bottom right of the screen, as shown in Figure 7-8.

Figure 7-8 Repeatability test result

6. To research for repeatability information, tap "Statistics", the screen shown in Figure
7-9 will be displayed.

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 Performance Test

Figure 7-9 Statistics

23
 Data Management Software

Chapter 8 Data Management Software

NOTE
Refer to the user manual of the data management software for its installation.

Connection Setup of the Data Management Software

and the Analyzer
IP addresses of the PC and the analyzer shall be in the same IP segment, as Figure 8-1
shows.

Figure 8-1 Communication parameter setup

Start the Mindray Hematology Online Communication program, select communication

device management to setup network parameters. See Figure 8-2.

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 Data Management Software

Figure 8-2 Communication parameter setup

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:

25
 Data Management Software

Figure 8-3 Communication setup of the analyzer

Connection setup of the data management software and the analyzer is completed.
Start the Mindray Hematology Online Communication program, set up the
communication parameters and initiate the connection. When the screen in Figure 8-4 is
displayed, the data management software and the analyzer have been connected
successfully.

26
 Data Management Software

Figure 8-4 Network connected

27
 Installation Checklist

Chapter 9 Installation Checklist

No. Module Description Standard Result
No. Inspection Item Reference
1 Ambient Within the 10℃～30℃ □Pass
Temperature operating □Fail
temperature range
2 Ambient Within the 20%～85% □Pass
Humidity operating humidity □Fail
range
3 Operating Atmospheric Within the 70KPa～ □Pass
Environment pressure operating 106KPa □Fail
atmospheric
pressure range
4 Electromagnetic Be away from / □Pass
interference electromagnetic □Fail
interference
sources
5 Space Requirements Analyzer space Meets the □Pass
installation □Fail
requirements
6 Power Requirements Power, voltage Meet the □Pass
and frequency requirements in □Fail
Table2-2
7 Tube models Tubes meet the Meet the □Pass
specification requirement in □Fail
requirement section 2.4

No. Module Description Standard Result

No. Inspection Item Reference
1 The package box Package and Package and □Pass □Fail
and appearance of appearance appearance are in
the main unit good condition
2 Packing list Items in packing list All items are ready □Pass □Fail
3 Connection of waste Waste pipe and Properly □Pass □Fail
sensor connected and not
bent
4 Connection of diluent Waste pipe and Properly □Pass □Fail
sensor connected and not
bent
5 Connection of Lyse Connection of lyse Properly □Pass □Fail
container cap connected and not
bent
6 Supporting board Diluent container Install the □Pass □Fail

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 Installation Checklist

installation supporting board

7 Height of diluent Height of the diluent No less than1m □Pass □Fail
to the analyzer

No. Module Description Standard Result

No. Inspection Item Reference
1 Temperature status of Each temperature Within the □Pass □Fail
the analyzer value specified range
2 Voltage and current Each voltage and Within the □Pass □Fail
current value specified range
3 Reagent Setup Barcode and lot No. The settings are □Pass □Fail
setup correct
4 Maintenance Setup Maintenance setup Meet client □Pass □Fail
contents requirements

No. Module Description Standard Measured Result

No. Inspection Item Reference value
Value
1 WBC ≤ 0.20  109 / L □Pass □Fail
12
2 RBC ≤ 0.02 10 / L □Pass □Fail
3 Background HGB ≤1 g/L □Pass □Fail
4 HCT ≤0.5 % □Pass □Fail
9
5 PLT ≤ 10  10 / L □Pass □Fail
6 WBC ≤2.0% □Pass □Fail
7 RBC ≤1.5% □Pass □Fail
Repeatability
8 HGB ≤1.5% □Pass □Fail
(whole blood)
9 MCV ≤1.0% □Pass □Fail
10 PLT ≤4.0% □Pass □Fail

29
P/N： 046-004695-00(1.0)