BC-5000 BC-5150 BC-5120

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.
 Revision History

Version Date of Cause of Page No. SER. Come into

No. Revision Revision

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

2.0 09/2013 Software interfac Chapter 5,6,7,8

e have been ch
anged.

/ liu lijia

3.0 02/2014 Add the Chapter 4

requirement that
Bottle gap
module should
be screwed to
avoid leak /liu
lijia

4.0 06/2014 Add the function Chapter 6.1

of the recorder
/liu lijia

5.0 10/2014 Software interfac Chapter 6.1,7.2

e have been ch
anged.

/ liu lijia

6.0 12/2015 Add a bidding Cover

model

7.0 2020/12 Update reagent Chapter 5.2

setup/Qi Yufan
Chapter 6.3
Add external
RFID card/Qi
Yufan
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

I
 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.

II
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

III
 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.

IV
 Table of Contents
Chapter 1 Preparations............................................................................................................... 1-1
1.1 Purpose ........................................................................................................................ 1-1
1.2 Tools ............................................................................................................................ 1-1
1.3 Consumables ............................................................................................................... 1-1

Chapter 2 Installation Requirements ........................................................................................ 2-1

2.1 Operating Environment ............................................................................................... 2-1
2.2 Space Requirements .................................................................................................... 2-2
2.3 Power Requirements ................................................................................................... 2-2
2.4 Confirming the Tube Type on Site .............................................................................. 2-3

Chapter 3 Unpacking .................................................................................................................. 3-1

3.1 Checking Before Unpacking ....................................................................................... 3-1
3.2 Unpacking the Main Unit ............................................................................................ 3-1
3.3 Checking Packing List ................................................................................................ 3-3

Chapter 4 Connections................................................................................................................ 4-1

Chapter 5 Startup and Setup...................................................................................................... 5-1

5.1 Initial start-up .............................................................................................................. 5-1
5.2 Reagent Setup ............................................................................................................. 5-2
5.3 Maintenance Setup ...................................................................................................... 5-3

Chapter 6 Other Functions ......................................................................................................... 6-1

6.1 Print ............................................................................................................................. 6-1
6.2 External Barcode Scanner ........................................................................................... 6-1
6.3 External RFID Reader ................................................................................................. 6-2

Chapter 7 Performance Test....................................................................................................... 7-1

7.1 Background Verification ............................................................................................. 7-1
7.2 Reproducibility............................................................................................................ 7-4

Chapter 8 Data Management Software ..................................................................................... 8-1

8.1 Connection Setup of the Data Management Software and the Analyzer .................... 8-1

Chapter 9 Installation Checklist ................................................................................................ 9-1

1
 Chapter 1 Preparations
1.1Purpose
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.

1.2Tools
1. Blade or clipper
2. USB
3. Pipette (200ul)
4. Cross-headed screwdriver

1.3Consumables
1. Plastic test tube
2. Glass pipette
3. Gloves
4. Dust-free tissue
5. Calibrator
6. Control (normal)

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

2-1
 Installation Requirements

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.

2-2
 Installation Requirements

⚫ 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) and 0.5ml, for pre-diluted 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).

2-3
 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.

3-1
 Unpacking

Figure 3-2 taking off the accessory package

3. 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

4. Remove the plastic bag from the main unit. Grab the bottom of the main unit and lift

3-2
 Unpacking

it onto a countertop. Note that the main unit must be lifted by 1 to 2 persons, as
shown in 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.
See Figure 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.

3-3
 Chapter 4 Connections
1. See Figure 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.

Figure 4-1 Back of the analyzer, reagent and waste connection

4-1
 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 in Figure 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.

4-2
 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

4-3
 Connections

M-52DIFF lyse connector

M-52LH lyse connector

Figure 4-5 Properly connected wires and lines

Bottle gap module should be screwed to avoid leak after connecting all reagents. Then
close the left door.

4. Connect the network cable to the network port, as shown in Figure 4-6. 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.

Figure 4-6 USB port and network port

4-4
 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 ID (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.

5-1
 Startup and Setup

5.2 Reagent Setup

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

Tap this button

Figure 5-2 Reagent Setup

2. Tap “OK” and switch to the RFID Closed-reagent as per the guidance on the screen.
Setup and replace the diluent and lyse according to your instrument configuration.
◼ Reagent Setup for Non-Indian Clients
1. Tap the "Reagent Setup" button to enter the screen shown in Figure 5-3.

5-2
 Startup and Setup

Tap this button

Figure 5-3 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 5-4.

NOTE
⚫ The default setting is recommended.

5-3
 Startup and Setup

Figure 5-4 Maintenance Setup

5-4
 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.

Figure 6-2 Connecting the external scanner

6-1
 Other Functions

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

6.3 External RFID Reader

If you need to use external RFID reader, you need to insert the micro USB connector to the
external RFID reader (on the side) and insert the USB connector to the USB socket on the
left side of the main unit, as shown in the following figure. The external RFID reader is used
for reading RFID card.

Figure 6-4 Connect external RFID reader

6-2
 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

7-1
 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.

7-2
 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

7-3
 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

Parameter Range Whole blood Pre-diluted

sample sample
reproducibility reproducibility
(CV/Absolute (CV/Absolute
deviation d) deviation d)
WBC 4.00×109/L～15.00 109 / L ≤2.5% ≤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)
3.50  1012 / L ~ 6.00  1012 / ≤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
150  109 / L ~ 500  109 / L ≤4.0% ≤8.0%
MPV / ≤4.0% ≤8.0%
PDW / ≤4.0% /

◼ Procedure
◆ Whole blood reproducibility test
1. Tap "Performance"-“Reproducibility” to enter the reproducibility test screen. See
Figure 7-5.

7-4
 Performance Test

Figure 7-5 Reproducibility test

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

7-5
 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.

7-6
 Performance Test

Figure 7-8 Reproducibility test result

6. To research for reproducibility information, tap "Statistics", the screen shown in

Figure 7-9 will be displayed.

7-7
 Performance Test

Figure 7-9 Statistics

7-8
 Chapter 8 Data Management Software

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

8.1 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.

8-1
 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:

8-2
 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.

8-3
 Data Management Software

Figure 8-4 Network connected

8-4
 Chapter 9 Installation Checklist
No. Module Description Standard Result
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

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

9-1
 Installation Checklist

No. Module Description Standard Result

Inspection Item Reference
installation supporting board
7 Height of diluent Height of the diluent No less than1m □Pass □Fail
to the analyzer

No. Module Description Standard Result

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

Inspection Item Reference value
Value
1 WBC ≤ 0.20  109 / L □Pass □Fail
2 RBC ≤ 0.02 1012/ L □Pass □Fail
3 Background HGB ≤1 g/L □Pass □Fail
4 HCT ≤0.5 % □Pass □Fail
5 PLT ≤ 10  109 /L □Pass □Fail
6 WBC ≤2.0% □Pass □Fail
7 RBC ≤1.5% □Pass □Fail
Reproducibility
8 HGB ≤1.5% □Pass □Fail
(whole blood)
9 MCV ≤1.0% □Pass □Fail
10 PLT ≤4.0% □Pass □Fail

9-2
P/N： 046-004695-00(7.0)