BC-30S BC-20S 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 ...............................................................................................................9

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 Reproducibility ................................................................................................................19
7.3 Verify accuracy ...............................................................................................................23

Chapter 8 Data Management Software .................................................................................26

Chapter 9 Installation Checklist .............................................................................................30

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

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℃～35℃ -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
 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 20Kg.

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.

3
 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:
1. Ф12-15×75mm (without cap) evacuated blood collection tube for whole-blood
analyses.
2. Ф11×40mm 1.5ml centrifugal tube and 0.5mlcentrifugal tube for predilute and
capillary whole-blood analyses.
3. Ф10.7×42mm (without cap) closed anticoagulant collection tube for capillary
whole-blood analyses (supports open-vial analyses). Recommended model: 0.5ml
closed anticoagulant collection tube manufactured by BD (ID: 365974).

4
 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.

5
 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

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.

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.

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.

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

Figure 4-2 Left of the analyzer, lyse connection

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

Waste sensor connector Power socket

Figure 4-3 Properly connected wires and lines

10
 Connections

lyse connector

Figure 4-4 Properly connected wires and lines

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.

Figure 4-5 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 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"," 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.

12
 Startup and Setup

Tap this button

Figure 5-2 Reagent Setup

2. Complete the setup and replacement of "Diluent",and " lyse" using the barcode
scanner or enter the numbers under the barcode 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.

13
 Startup and Setup

Figure 5-3 Maintenance Setup

14
 Other Functions

Chapter 6 Other Functions

6.1 Print
Tap "Menu”-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.

15
 Other Functions

Figure 6-2 Connecting the external scanner

16
 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 ≤ 5  109 / L

 Procedure
1. Tap "Menu”-“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 change blood sample 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.

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.

18
 Performance Test

Figure 7-4 Export test results

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

Paramet Range Whole blood sample Pre-diluted sample

er reproducibility reproducibility
(CV/Absolute deviation d) (CV/Absolute deviation d)
9
7.0 ~ 15.0  10 / L ≤ 2.0
WBC 9 CV%
4.0 ~ 6.9  10 / L ≤ 3.5
RBC 3.50 ~ 6.50  1012 / L ≤ 1.5 ≤ 4.0
HGB 100 ~ 180 g/L ≤ 1.5 ≤ 2.0
MCV 70.0~ 110.0 fL ≤ 0.5 ≤ 2.0
9
150 ~ 500  10 / L ≤ 4.0
PLT 9 ≤1.5
100~149 10 / L ≤ 5.0
Lymph% Lymph%≥15%
≤12% ≤12%
WBC≥4.0×109/L

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.

Figure 7-5 Reproducibility test

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

20
 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 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.

21
 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.

22
 Performance Test

Figure 7-9 Statistics

7.3 Verify accuracy

Brief description: Use coordinate calibrator or fresh blood specimen to verify the
accuracy of the instrument. Follow operation steps metioned below:

7.3.1 Using coordinate calibrator

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.

7.3.2 Using fresh blood specimen

1. Use EDTA.K2 anticoagulant vacuum tube( 1ml blood versus 1.5mg~2.2mg
anticoagulation) to obtaion as least 3~5 fresh blood specimens from healthy people,
2.5mL volume each. It is required that HGB, WBC, RBC, MCV, PLT parameters are
in the normal reference range(as table 7.2 reproducibility requirements).
2. Use laboratory certificated or calibrated equipments to implement 5~10 tests
continuously. Calculate the mean value of all the results. Use these means as target
value of the fresh blood specimens.

7.3.3Calibration Process

1：Calibration with Calibrator

1. Chose “calibratration” > “Calibrator” in drop-down manual, enter the interface as
below.

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.

2：Calibration with Fresh Blood

1. Chose “calibratration” > “Fresh blood” in drop-down manual, enter the interface as
below.

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

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 (default IP
address:10.0.0.2), 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.

26
 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:

27
 Data Management Software

Figure 8-3 Communication setup of the analyzer

default settings：IP address:10.0.0.2,Subnet Mask: 255.255.255.0,Default Gateway ：
10.0.0.254.Refer to your network administrator for certain setting.
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.

28
 Data Management Software

Figure 8-4 Network connected

29
 Installation Checklist

Chapter 9 Installation Checklist

No. Module Description Standard Result
Inspection Item Reference
1 Ambient Within the operating 10℃～35℃ □ Pass
Temperature temperature range □ Fail
2 Ambient Within the operating 20%～85% □ Pass
Humidity humidity range □ Fail
3 Atmospheric Within the operating 70KPa～ □ Pass
Operating
pressure atmospheric 106KPa □ Fail
Environment
pressure range
4 Electromagnet Be away from / □ Pass
ic interference electromagnetic □ Fail
interference
sources
5 Space Requirements Analyzer space Meets the □ Pass
installation □ Fail
requirements
6 Power Requirements Power, voltage and Meet the □ Pass
frequency requirements □ Fail
in 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
and appearance of appearance appearance are in □ Fail
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
sensor connected and not □ Fail
bent
4 Connection of diluent Waste pipe and Properly □ Pass
sensor connected and not □ Fail
bent
5 Connection of Lyse Connection of lyse Properly □ Pass
container cap connected and not □ Fail
bent
7 Height of diluent Height of the diluent No less than1m □ Pass
to the analyzer □ Fail

30
 Installation Checklist

No. Module Description Standard Result

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

No. Module Description Standard Measured Result

No. Inspection Item Reference value
Value
1 WBC □ Pass
≤ 0.20  109 / L
□ Fail
2 RBC □ Pass
≤ 0.02 1012/ L
□ Fail
3 HGB □ Pass
Background ≤1 g/L
□ Fail
4 HCT □ Pass
≤0.5 %
□ Fail
5 PLT □ Pass
≤ 5  109 / L
□ Fail
6 WBC □ Pass
≤2.0%
□ Fail
7 RBC □ Pass
≤1.5%
□ Fail
8 Reproducibility HGB □ Pass
≤1.5%
(whole blood) □ Fail
9 MCV □ Pass
≤0.5%
□ Fail
10 PLT □ Pass
≤4.0%
□ Fail
□ Pass
11 Verify accuracy / / /
□ Fail

31
P/N： 046-007157-00(1.0)