BC-5130 Auto Hematology Analyzer

Operator’s Manual
© 2015-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2016-10.

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of

Mindray is strictly forbidden.

, , are the trademarks, registered or otherwise, of Mindray in

China and other countries. All other trademarks that appear in this manual are used only for

informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
 all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;
 the electrical installation of the relevant room complies with the applicable national and
local requirements; and the product is used in accordance with the instructions for use.

I
 WARNING
 It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or personal injury.

 Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.

NOTE
 This equipment must be operated by skilled/trained clinical professionals.

II
Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
 Malfunction of the instrument or part whose serial number is not legible enough.
 Others not caused by instrument or part itself.

Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building,Keji 12th Road South,High-tech industrial
park,Nanshan,Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail Address: [email protected]
Tel: +86 755 81888998

Fax: +86 755 26582680

EC-Representative: Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestraβe 80, 20537 Hamburg, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

III
 Table of Contents
Table of Contents ....................................................................................................................... 1

1 Using This Manual ................................................................................................. 1-1

1.1. Introduction ............................................................................................................ 1-1
1.2. Who Should Read This Manual ............................................................................. 1-2
1.3. How to Find Information ........................................................................................ 1-3
1.4. Conventions Used in This Manual ......................................................................... 1-4
1.5. Safety Information ................................................................................................. 1-5
1.6. Symbols ................................................................................................................. 1-7

2 Understanding the Analyzer .................................................................................. 2-1

2.1. Introduction ............................................................................................................ 2-1
2.2. Parameters ............................................................................................................ 2-2
2.3. Product Description ............................................................................................... 2-5
2.4. Status Indicator ...................................................................................................... 2-9
2.5. Buzzer.................................................................................................................. 2-10
2.6. System Menu ....................................................................................................... 2-11
2.7. Reagents, Controls and Calibrators .................................................................... 2-12
2.7.1. Reagents ................................................................................................ 2-12
2.7.2. Controls and Calibrators ........................................................................ 2-13

3 Understanding the System Principles ................................................................... 3-1

3.1. Introduction ............................................................................................................ 3-1
3.2. Aspiration ............................................................................................................... 3-2
3.3. Dilution ................................................................................................................... 3-3
3.4. WBC Measurement ............................................................................................... 3-5
3.5. HGB Measurement ................................................................................................ 3-6
3.6. RBC/PLT Measurement ......................................................................................... 3-7

4 Installing Your Analyzer ......................................................................................... 4-1

4.1. Introduction ............................................................................................................ 4-1
4.2. Installation Requirements ...................................................................................... 4-2
4.2.1. Space Requirements ................................................................................ 4-2
4.2.2. Power Requirements ................................................................................ 4-2
4.2.3. General Environment ............................................................................... 4-3
4.2.4. Moving and Installing the Analyzer........................................................... 4-3
4.3. Connecting the Analyzer System .......................................................................... 4-4
4.4. Notes ..................................................................................................................... 4-8

5 Operating Your Analyzer ........................................................................................ 5-1

5.1. Introduction ............................................................................................................ 5-1

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 Table of Contents

5.2. Initial Checks ......................................................................................................... 5-3

5.3. Startup and Logon ................................................................................................. 5-4
5.4. Daily Quality Control .............................................................................................. 5-8
5.5. Sample Collection and Handling ........................................................................... 5-9
5.5.1. Sample Preparation ............................................................................... 5-11
5.5.2. Sample Analysis ..................................................................................... 5-13
5.5.3. Processing Analysis Results .................................................................. 5-19
5.6. Auto-Standby ....................................................................................................... 5-22
5.7. Shutdown ............................................................................................................. 5-24

6 Reviewing Sample Results .................................................................................... 6-1

6.1. Introduction ............................................................................................................ 6-1
6.2. Browsing in the "Table Review" mode ................................................................... 6-2
6.2.1. Table ......................................................................................................... 6-2
6.2.2. Graph Review........................................................................................... 6-3
6.2.3. Validate/Cancel Validate (for administrators only).................................... 6-5
6.2.4. Delete (for administrators only) ................................................................ 6-6
6.2.5. Edit info. ................................................................................................... 6-7
6.2.6. Edit results ................................................................................................ 6-7
6.2.7. Search ...................................................................................................... 6-8
6.2.8. Print .......................................................................................................... 6-9
6.2.9. Transmission ............................................................................................ 6-9
6.2.10. Export ..................................................................................................... 6-10

7 Using the QC Programs ........................................................................................ 7-1

7.1. Introduction ............................................................................................................ 7-1
7.2. L-J QC ................................................................................................................... 7-3
7.2.1. Editing L-J Settings (for administrators only) ........................................... 7-3
7.2.2. L-J QC Run .............................................................................................. 7-6
7.2.3. Reviewing L-J Results ............................................................................ 7-10
7.3. X-B QC Program ................................................................................................. 7-15
7.3.1. Introduction ............................................................................................. 7-15
7.3.2. Editing X-B settings (for administrators only) ......................................... 7-15
7.3.3. X-B QC Run ........................................................................................... 7-19
7.3.4. Reviewing X-B Results ........................................................................... 7-19

8 Calibrating Your Analyzer ...................................................................................... 8-1

8.1. Introduction ............................................................................................................ 8-1
8.2. When to Calibrate .................................................................................................. 8-3
8.3. How to Calibrate .................................................................................................... 8-4
8.3.1. Preparing Your Analyzer ........................................................................... 8-4
8.3.2. Manual Calibration ................................................................................... 8-4
8.3.3. Calibration with Calibrator ........................................................................ 8-6
8.3.4. Calibration with Fresh Blood .................................................................. 8-11

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 Table of Contents

9 Customizing the Analyzer Software ....................................................................... 9-1

9.1. Introduction ............................................................................................................ 9-1
9.2. Setting Up the Analyzer ......................................................................................... 9-2
9.2.1. System Setup ........................................................................................... 9-2
9.2.2. Access Setup ......................................................................................... 9-10
9.2.3. Auxiliary Setup ....................................................................................... 9-13
9.2.4. Parameter Setup .................................................................................... 9-15
9.2.5. Maintenance Setup (for administrators only) ......................................... 9-20
9.2.6. Reagent Setup ....................................................................................... 9-20
9.2.7. Gain Setup (for administrators only) ...................................................... 9-23
9.3. Save the settings ................................................................................................. 9-25

10 Servicing Your Analyzer ....................................................................................... 10-1

10.1. Introduction .......................................................................................................... 10-1
10.2. Maintaining Your Analyzer ................................................................................... 10-2
10.2.1. Maintenance ................................................................................... 10-2
10.2.2. Cleaning .......................................................................................... 10-4
10.2.3. Servicing the Fluidics ...................................................................... 10-5
10.3. Touch Screen Calibration .................................................................................... 10-9
10.4. Viewing Logs ..................................................................................................... 10-10
10.5. Checking the Analyzer Status ........................................................................... 10-12
10.5.1. Counter ......................................................................................... 10-12
10.5.2. Temp. & Pressure ......................................................................... 10-13
10.5.3. Voltage and Current ...................................................................... 10-14
10.5.4. Sensor .......................................................................................... 10-15
10.5.5. Version Info. .................................................................................. 10-16

11 Troubleshooting Your Analyzer ............................................................................ 11-1

11.1. Introduction .......................................................................................................... 11-1
11.2. Error Information and Handling ........................................................................... 11-2

12 Appendices ............................................................................................................ A-1

3
 1 Using This Manual

1.1. Introduction
This chapter explains how to use your BC-5130 Operator’s Manual, which is shipped with
your BC-5130 AUTO HEMATOLOGY ANALYZER (hereafter referred as “the analyzer”) and
contains reference information about the analyzer and procedures for operating,
troubleshooting and maintaining the analyzer. Read this manual carefully before operating
your analyzer and operate your analyzer strictly as instructed in this manual.

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 Using This Manual

1.2. Who Should Read This Manual

This manual is intended to be read by clinical laboratory professionals. This equipment must
only be operated by skilled/trained clinical professionals. This information contains
information for clinical laboratory professionals to:

 learn about the hardware and software of the analyzer.

 customize system settings.

 perform daily operating tasks.

 perform system maintenance and troubleshooting.

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 Using This Manual

1.3. How to Find Information

This operator’s manual comprises 11 chapters and 3 appendices. Refer to the table below to
find the information you need.

If you want to … See …

learn about the intended use and parameters of the Chapter 2 Understanding
analyzer Your Analyzer
learn about the hardware, interface and software of the Chapter 2 Understanding
analyzer Your Analyzer
learn about how the analyzer works Chapter 3 Understanding
the System Principles
learn about the installation requirements of the analyzer Chapter 4 Installing Your
Analyzer
learn about the process of sample collection and analysis Chapter 5 Operating Your
Analyzer
learn about how to use the analyzer to perform your daily Chapter 5 Operating Your
operating tasks Analyzer
learn about how to review sample results on the analyzer Chapter 6 Reviewing
Sample Results
learn about how to use the quality control programs of the Chapter 7 Using the QC
analyzer Programs
learn about how to calibrate the analyzer Chapter 8 Using the
Calibration Programs
learn about how to define/adjust system settings Chapter 9 Customizing the
Analyzer Software
learn about how to maintain/service the analyzer Chapter 10 Maintaining
Your Analyzer
learn about how to solve the problems of the analyzer Chapter 11
Troubleshooting Your
Analyzer
learn about the technical specifications of the analyzer Appendix B Specifications

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 Using This Manual

1.4. Conventions Used in This Manual

This manual uses certain typographical conventions to clarify meaning in the text:

Format Indication
[××] all capital letters enclosed in [ ] indicate a key name on the
analyzer or external keyboard, such as [ENTER]
"××" bold letters included in " " indicate text you may find on the
screen of BC-5130, such as “Clear”
×× bold letters indicate chapter titles, such as Chapter 1 Using
This Manual.

All illustrations in this manual are provided as examples only. They may not necessarily
reflect setup of the BC-5130 or data displayed.

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 Using This Manual

1.5. Safety Information

The following symbols are used to indicate danger and alert information in this manual.

When you see… Meaning

read the statement below the symbol. The statement is alerting
you to a potentially biohazardous condition.

read the statement below the symbol. The statement is alerting

WARNING you to an operating hazard that can cause personnel injury.

read the statement below the symbol. The statement is alerting

CAUTION you to a possibility of analyzer damage or unreliable analysis
results.
read the statement below the symbol. The statement is alerting
NOTE you to information that requires your attention.

 All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

 If leak happens to the analyzer, the leak liquid is potentially biohazardous.

WARNING
 Please check the firmness of all the doors and covers before running the
analyzer.

 Make sure all the safety measurements are adopted. Disable any safety
device or sensor is prohibited.

 Please take action to any alarm and problem indication immediately.

 Do not touch the moving parts.

 Contact Mindray or Mindray-authorized distributors in time if any damaged

part is found.

 Be careful when opening/closing and removing/installing the doors, covers

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 Using This Manual

and boards of the analyzer.

 Discard the analyzer according to government regulations.

 Do not contact the patients‟ sample blood directly.

 Be sure to dispose of reagents, waste, samples, consumables, etc.

according to government regulations.

 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.

 Keep your clothes, hairs and hands away from the moving parts to avoid
injury.

 The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

 Before maintaining or servicing the analyzer, its surface or the sample

probe and other parts concerned must be cleaned and sterilized (it is
recommend that the parts be wiped with alcohol of which the concentration
is 75%) to avoid biohazards or other damages.

CAUTION
 Please use the analyzer strictly according to this manual.

 Please adopt proper measurements to prevent the reagents from being

polluted.

NOTE
 Use the reagents specified by the manufacturer only. Store and use the
reagents as instructed by instructions for use of the reagents.

 Check if the reagent tubes are properly connected before using the analyzer.

1-6
 Using This Manual

1.6. Symbols
You will find the following symbols in this manual:

When you see… Meaning

read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.

read the statement below the symbol. The statement is

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

You may find the following symbols of the analyzer system:

CAUTION
 Make sure the symbols are in good condition during daily use and maintenance.

When you see… Meaning

CAUTION,
CONSULT ACCOMPANYING
DOCUMENTS.
BIOLOGICAL RISK

WARNING, LASER BEAM

PROTECTIVE EARTH (GROUND)

USB PORT

NETWORK PORT

1-7
Using This Manual

ALTERNATING CURRENT

FOR IN VITRO DIAGNOSTIC USE

SERIAL NUMBER

DATE OF MANUFACTURE

EXERCISE CAUTION WHEN WORKING

AROUND TO AVIOD PRICKING

MANUFACTURER

TEMPERATURE LIMITATION

CONSULT THE OPERATOR'S MANUAL

THE FOLLOWING DEFINITION OF THE

WEEE LABEL APPLIES TO EU MEMBER
STATES ONLY: THE USE OF THIS
SYMBOL INDICATES THAT THIS
PRODUCT SHOULD NOT BE TREATED
AS HOUSEHOLD WASTE. BY
ENSURING THAT THIS PRODUCT IS
DISPOSED OF CORRECTLY, YOU WILL
HELP PREVENT BRINGING POTENTIAL
NEGATIVE CONSEQUENCES TO THE
ENVIRONMENT AND HUMAN HEALTH.
FOR MORE DETAILED INFORMATION
WITH REGARD TO RETURNING AND
RECYCLING THIS PRODUCT, PLEASE
CONSULT THE DISTRIBUTOR FROM
WHOM YOU PURCHASED THE
PRODUCT.
THE DEVICE IS FULLY CONFORMANCE
WITH THE COUNCIL DIRECTIVE
CONCERNING IN VITRO DIAGNOSTIC

1-8
Using This Manual

MEDICAL DEVICES 98/79/EC.

AUTHORISED REPRESENTATIVE IN THE

EUROPEAN COMMUNITY

1-9
 Using This Manual

Figure 1-1 Back of the analyzer

(1)

 Connect only to a properly earth grounded outlet.

 To avoid electric shock, disconnect power cord prior to removing or replacing fuse.

 Replace fuse only with the type and rating specified.

(2)
 Warning, potential biological risk.

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 Using This Manual

Figure 1-2 Front of the analyzer

(1)
Warning, potential biohazardous risk.

(2)
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact
with the probe when working around it.

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 Using This Manual

Figure 1-3 Front of the analyzer (front cover open)

(1)

 Do not put hands under the syringe or in the guide slot when the analyzer is running.

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 Using This Manual

Figure 1-4 Right of the analyzer

(1)
Do not put hands under the syringe or in the guide slot when the analyzer is running.

1-13
 Using This Manual

Figure 1-5 Left of the analyzer

(1)
Caution: Class 3B Laser radiation when open and interlocks defeated avoid exposure to the
beam

1-14
 2 Understanding the Analyzer

2.1. Introduction
This chapter introduces the parameters, major components, interfaces, buttons, menus,
software help system, operation information and reagent system of the BC-5130 AUTO
HEMATOLOGY ANALYZER.

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 Understanding the Analyzer

2.2. Parameters

NOTE
 The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that
require additional studies.

The analyzer determines 25 parameters, 10 RUO parameters, 3 histograms and 1

scattergram of blood samples. The parameters under CBC and CBC+DIFF mode are listed
as follows:

Table 2-1 Parameters

Parameter
Name Abbreviation CBC CBC + DIFF
Group
White Blood Cell count WBC √ √
Basophils number Bas# / √
Basophils percentage Bas% / √
Neutrophils number Neu# / √
Neutrophils percentage Neu% / √
WBC group (11)

Eosinophils number Eos# / √

Eosinophils percentage Eos% / √
Lymphocytes number Lym# / √
Lymphocytes Lym% / √
percentage
Monocytes number Mon# / √
Monocytes percentage Mon% / √
Abnormal Lymphocytes ALY# √
RUO parameters(10)

/
number
Abnormal Lymphocytes ALY% / √
percentage
Large Immature Cells LIC# / √
number
Large Immature Cells LIC% / √
percentage
Platelet clump number PLT Clumps# / √
Platelet clump PLT Clumps% / √
percentage
Lipid granule number Lip# / √
Lipid granule percentage Lip% / √

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 Understanding the Analyzer

Nucleated red blood cell NRBC# / √

(NRBC) number
Nucleated red blood cell NRBC% / √
(NRBC) percentage
Red Blood Cell count RBC √ √
Hemoglobin HGB √ √
Concentration
Mean Corpuscular MCV √ √
Volume
Mean Corpuscular MCH √ √
Hemoglobin
√ √
RBC group (8)

Mean Corpuscular MCHC

Hemoglobin
Concentration
Red Blood Cell RDW-CV √ √
Distribution Width -
Coefficient of Variation
Red Blood Cell RDW-SD √ √
Distribution Width -
Standard Deviation
Hematocrit HCT √ √
Platelet count PLT √ √
Mean Platelet Volume MPV √ √
Platelet Distribution PDW √ √
PLT group (6)

Width
Plateletcrit PCT √ √
Platelet larger cell ratio P-LCR √ √
Platelet larger cell count P-LCC √ √

 Histograms

Table 2-2 Histograms

Name Abbreviation CBC CBC + DIFF

White Blood Cell Histogram WBC Histogram √ √
Red Blood Cell Histogram RBC Histogram √ √
Platelet Histogram PLT Histogram √ √

 Scattergram

Table 2-3 Scattergram

Abbreviation CBC CBC + DIFF

Diff Scattergram / √

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 Understanding the Analyzer

NOTE
 "√"means "available under the mode","/"means "not available under the
mode".

 ALY%, LIC%, PLT Clumps%, Lip%, NRBC% ,ALY#,LIC#, PLT Clumps#, Lip#,
and NRBC# are for research use only.

2-4
 Understanding the Analyzer

2.3. Product Description

BC-5130 AUTO HEMATOLOGY ANALYZER includes the Sample Processing Unit (SPU),
Data Managing Unit (DMU), Result Output Unit (ROU) and accessories.

WARNING
 Please check the firmness of all the doors and covers before running the
analyzer, and make sure they do not get loose when the analyzer is running.

Figure 2-1 Front of the analyzer

1 ---- [Aspirate] key 2 ---- Sample probe

3 ----Probe wipe block 4 ----Power/status indicator
5 ----Display

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 Understanding the Analyzer

Figure 2-2 Back view of the analyzer

1 --- M-52D diluent inlet 2 ---Waste outlet

3 --- Waste sensor 4 ---AC input
5 --- Power switch

2-6
 Understanding the Analyzer

Figure 2-3 Left view of the analyzer (left door open)

1 --- Left door 2 --- DIFF reagent bottle

3 --- LH reagent bottle 4 --- Front cover assembly
5 --- Network port/USB port

2-7
 Understanding the Analyzer

 Power switch
Power switch is located on the back of the analyzer.

CAUTION
 Do not turn on/off the switch repeatedly in a short time to avoid damaging
the analyzer.

 [Aspirate] key
The [Aspirate] key is on the front of the analyzer. Press the [Aspirate] key to start analysis,
dispense diluent or exit from standby mode.

 USB/network ports
The USB ports and network ports are on the left side of the analyzer. The USB ports connect
printer, barcode scanner, etc.. The network ports are used to transmit data.

The supported printer models include:

 EPSON LQ-590K
 HP Laser Jet P1505n
 HP OfficeJet Pro K5300
 HP LaserJet P1606dn.

2-8
 Understanding the Analyzer

2.4. Status Indicator

The status indicator is on the front of the analyzer. The indicator indicates the ready, running,
error and standby status of the analyzer.
The indicator illuminates in 3 colors to indicate different status of the analyzer.

Table 2-4 the indicator and analyzer status

Status Indicator Note

Ready Solid green The analyzer is ready to
operate

Running Flickering green The analyzer is running

Running with error Flickering red The analyzer is running

with error

Error Solid red An error has occurred, and

the analyzer is not running

No error, but fluidic Solid yellow This status occurs under

actions are not two situations:
allowed. 1. The analyzer is
initializing (not involving
fluidic actions) in
startup process;
2. The analyzer is standby

Entering/exiting Flickering yellow Entering/exiting standby

standby status status

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 Understanding the Analyzer

2.5. Buzzer
The buzzer indicates errors of the analyzer. Tap the touch screen orremove the error to clear
the alarming sound of the buzzer.

Table 2-5 Buzzer and analyzer status

When... How... Note

The startup process completes 1 short beep The startup process
completes and the analyzer is
ready to run analysis.

Open vial sample aspiration 2 short beeps

finishes

Press the [Aspirate] key at the 1 long beep When dialog box message is
analysis screens (including given, the buzzer may not
sample analysis, QC, calibration, beep.
Reproducibility, carryover,
background, aging, optical gain
calibration screens) when
analysis cannot be started.

Error Long beeps at intervals Tap the touch screen to turn

off the buzzer.
The analyzer enters ready status 1 short beep The analyzer enters ready
status from another status.

When the analyzer screen turns Turn off the buzzer. If error occurs during the
black and the message "Please shutdown process, please
power off the analyzer" appears turn off the buzzer when the
screen turns black.

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 Understanding the Analyzer

2.6. System Menu

2-11
 Understanding the Analyzer

2.7. Reagents, Controls and Calibrators

As the analyzer, reagents (diluent, lyses, and probe cleanser), controls, and calibrators are
components of a system. Performance of the system depends on the combined integrity of all
components. Only Mindray-specified reagents (see Appendix B Specifications), which are
formulated specifically for the fluidic system of your analyzer in order to provide optimal
system performance, could be used. Do not use the analyzer with reagents from multiple
suppliers. Otherwise, the analyzer may not meet the performance specified in this manual
and may provide unreliable results. All references related to reagents in this manual refer to
the reagents specifically formulated for this analyzer.
Each reagent package must be examined before use. Product integrity may be compromised
in packages that have been damaged. Inspect the package for signs of leakage or moisture.
If there is evidence of leakage or improper handling, do not use the reagent.

NOTE
 Store and use the reagents as instructed by instructions for use of the
reagents.

 When you have changed the diluents or lyse, implement a background test
to see if the results meet the requirement.

 Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.

2.7.1.Reagents
M-52D Diluent

M-52D diluent provides stable solution environment for blood cells, dilutes blood sample,
generates sheath fluid and provides conductance in blood cell analysis process.

M-52DIFF Lyse

M-52DIFF lyse dissolves RBCs in the blood cell analysis process. It processes WBCs to
intensify the difference of the WBC sub-populations, and incorporates laser scatter and flow
cytometry to realize DIFF channel WBC analysis.

M-52LH Lyse

M-52LH lyse further processes the blood cells that have been processed by M-52DIFF lyse. It
turns hemoglobin into methemoglobin, which then measured by the colorimetric method. It
also processes WBCs to intensify the difference between basophils and other WBC
sub-populations, and incorporates laser scatter and flow cytometry to realize basophil
analysis.

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 Understanding the Analyzer

Probe Cleanser

Probe Cleanser is used to clean the analyzer regularly.

2.7.2.Controls and Calibrators

The controls and calibrators are used to verify accurate operation of and calibrate the
analyzer.
The controls are commercially prepared whole-blood products used to verify that the analyzer
is functioning properly. They are available in low, normal, and high levels. Daily use of all
levels verifies the operation of the analyzer and ensures reliable results are obtained. The
calibrators are commercially prepared whole-blood products used to calibrate the analyzer.
Store and use the controls and calibrators as instructed by their instructions for use.
All references related to controls and calibrators in this manual refer to the controls and
calibrators specifically formulated for this analyzer by Mindray. You must buy those controls
and calibrators from Mindray or Mindray-authorized distributors.

2-13
3 Understanding the System Principles

3.1. Introduction
The measurement methods used in this analyzer are: the Electrical Impedance method for
determining the RBC and PLT data; the colorimetric method for determining the HGB; flow
cytometry by laser for determining the WBC data. Other parameter results are obtained via
calculation.

3-1
 Understanding the System Principles

3.2. Aspiration
If you are to analyze a whole blood sample in the open vial sampling mode, the analyzer will
aspirate 15μL (CBC+DIFF mode) or 11.7μL (CBC mode) of the sample.
If you are to analyze a capillary blood sample in the open vial sampling mode, you should first
manually dilute the sample (20μL of capillary sample needs to be diluted by 480μL of diluent,
dilution ratio: 1:25) and then present the diluted sample to the analyzer, which will aspirate
200μL of the sample.

3-2
 Understanding the System Principles

3.3. Dilution
The aspirated sample will be quickly and precisely diluted in RBC bath and then segmented
into two portions. One of these two portions will then be diluted again and processed by
different reagents. After this, they are ready for analysis.
This analyzer can process two types of blood samples – whole blood samples and pre-diluted
sample.

 Whole Blood Mode

Aspirate
sample 15ul

Diluent
550ul

Dilution ratio Aspirate 12ul of

1:37.67 sample

Aspirate 380ul of DIFF lyse 1ml

the compound

LH lyse 200ul Diluent 2.4ml

WBC DIFF sample WBC BASO sample RBC sample

Dilution ratio Dilution ratio Dilution ratio
1:105.8 1:123.8 1:7533.3

Figure 3-1 Dilution procedure of whole blood CBC+DIFF mode

3-3
 Understanding the System Principles

 Pre-diluted Mode

Capillary blood
sample 20ul

Diluent 480ul

Dilution ratio
1:25

Aspirate
200ul of
Diluent sample
358ul

Aspirate 21.6ul of
Dilution ratio sample
1:69.75

DIFF lyse 1ml

Aspirate 380ul of
the compound

LH lyse 200ul Diluent 2.4ml

WBC DIFF sample WBC BASO sample RBC sample

Dilution ratio Dilution ratio Dilution ratio
1:199.8 1:234.3 1:7750

Figure 3-2 Dilution procedure of pre-diluted CBC+DIFF mode

3-4
 Understanding the System Principles

3.4. WBC Measurement

 Flow Cytometry by Laser

Figure 3-3 WBC Measurement

After a predetermined volume of blood is aspirated and diluted by a certain amount of reagent,
it is injected into the flow cell. Surrounded with sheath fluid (diluent), the blood cells pass
through the center of the flow cell in a single column at a faster speed. When the blood cells
suspended in the diluent pass through the flow cell, they are exposed to a laser beam. The
intensity of scatter light reflects the blood cell size and intracellular density. The low-angle
scattered light reflects cell size, and the high-angle scattered light reflects intracellular density
(nucleus size and density). The optical detector receives this scatter light and converts it into
electrical pulses. Pulse data collected can be used to draw a 3-dimensional distribution
(scattergram).

3-5
 Understanding the System Principles

3.5. HGB Measurement

 Colorimetric Method
The WBC/HGB dilution is delivered to the HGB bath where it is bubble mixed with a certain
amount of lyse, which converts hemoglobin to a hemoglobin complex that is measurable at
530 nm. An LED is mounted on one side of the bath and emits a beam of monochromatic light,
whose central wavelength is 530nm. The light passes through the sample and is then
measured by an optical sensor that is mounted on the opposite side. The signal is then
amplified and the voltage is measured and compared to the blank reference reading
(readings taken when there is only diluent in the bath), and the HGB is measured and
calculated in the analyzer automatically.

 HGB
The HGB is calculated per the following equation and expressed in g/L.
HGB(g/L) = Constant × Log 10 (Blank Photocurrent/Sample Photocurrent)

3-6
 Understanding the System Principles

3.6. RBC/PLT Measurement

 Electrical Impedance Method
RBCs/PLTs are counted and sized by the Electrical Impedance method. This method is
based on the measurement of changes in electrical resistance produced by a particle, which
in this case is a blood cell, suspended in a conductive diluent as it passes through an
aperture of known dimensions. A pair of electrodes is submerged in the liquid on both sides
of the aperture to create an electrical pathway. As each particle passes through the aperture,
a transitory change in the resistance between the electrodes is produced. This change
produces a measurable electrical pulse. The number of pulses generated represents the
number of particles that passed through the aperture. The amplitude of each pulse is
proportional to the volume of each particle.

Figure 3-4 Electrical Impedance method

Each pulse is amplified and compared to the internal reference voltage channel, which only
accepts the pulses of certain amplitude. If the pulse generated is above the RBC/PLT lower
threshold, it is counted as a RBC/PLT. The analyzer presents the RBC/PLT histogram, whose
x-coordinate represents the cell volume (fL) and y-coordinate represents the number of the
cells.

 Derivation of RBC-Related Parameters

 RBC
12
RBC (10 /L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.

3-7
 Understanding the System Principles

 MCV

Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
expresses the result in fL.

 HCT, MCH, and MCHC

This analyzer calculates the HCT(%), MCH (pg) and MCHC (g/L) as follows:
RBC  MCV
HCT 
10

HGB
MCH 
RBC

HGB
MCHC   100
HCT
12
Where the RBC is expressed in 10 /L, MCV in fL and HGB in g/L.

 RDW-CV

Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation) of the
erythrocyte distribution width, it is expressed in %.

 RDW-SD

Based on the standard deviation of erythrocyte size distribution, this analyzer calculates the
RDW-SD, its unit is fL.

 Derivation of PLT-Related Parameters

 PLT
9
PLT (10 /L) is measured directly by counting the platelets passing through the aperture.

 MPV

Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).

 PDW

Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet
size distribution. Each PDW result is derived from the platelet histogram data and is reported
as 10(GSD).

 PCT

This analyzer calculates the PCT as follows and expresses it in ％.

9
Where the PLT is expressed in 10 /L and the MPV in fL.

3-8
 Understanding the System Principles

PLT  MPV
PCT 
10000

 P-LCR

Platelet larger cell ratio (P-LCR) is the ratio of the larger platelet (volume larger than 12fL)
count to the total PLT count. This analyzer calculates the P-LCR based on the PLT histogram
and expresses the result in %. In the following figure, S2 represents the number of larger
platelet cells, and S1+S2 represents the total PLT count.

 P-LCC

This analyzer calculates the platelet large cell count (P-LCC) and expresses the result in
9
10 /L.

P- 3-9
 4 Installing Your Analyzer

4.1. Introduction

WARNING
 Installation by personnel not authorized or trained by Mindray may cause
personal injury or damage your analyzer. Do not install your analyzer
without the presence of Mindray-authorized personnel.

 The installation, authorization, upgrade and modification of the analyzer

software must be performed by Mindray-authorized personnel.

Your analyzer is tested before it is shipped from the factory. International symbols and special
handling instructions tell the carrier how to treat this electronic instrument. When you receive
your analyzer, carefully inspect the carton. If you see any signs of mishandling or damage,
contact Mindray customer service department or your local distributor immediately.

4-1
 Installing Your Analyzer

4.2. Installation Requirements

4.2.1.Space Requirements
Check the site for proper space allocation. In addition to the space required for the analyzer
itself, also observe the following requirements:

 Arrange proper height to place the analyzer;

 At least 50 cm on each side, which is the preferred access to perform service procedures;

 At least 10 cm behind the analyzer for cabling and ventilation;

 Enough room on and below the countertop to accommodate the reagents and waste
containers;

 The diluent container shall be put within 1.0m under the analyzer, lyse containers are
placed inside the analyzer.

 The countertop (or the floor) where the analyzer is placed shall be able to withstand at
least 40kg of weight.

4.2.2.Power Requirements

WARNING
 Make sure the analyzer is properly grounded.

 Before turning on the analyzer, make sure the input voltage meets the
requirements.

CAUTION
 Using pinboard may bring the electrical interference and the analysis
results may be unreliable. Please place the analyzer near the electrical outlet
to avoid using the pinboard.

 Please use the original power cable shipped with the analyzer. Using other
power cable may damage the analyzer or cause unreliable analysis results.

Table 4-1 Power specification

Voltage Input power Frequency

Analyzer (100V-240V～)±10% 300VA （50Hz/60Hz）±1Hz

4-2
 Installing Your Analyzer

4.2.3.General Environment
 Optimal operating temperature: 10 ℃～30 ℃

 Optimal operating humidity: 20 %～85 %

 Atmospheric pressure: 70 kPa～106 kPa

 The environment shall be free from dust, mechanical vibrations, loud noises, and
electrical interference.

 It is advisable to evaluate the electromagnetic environment prior to operation of this

analyzer.

 Do not use this analyzer in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper operation.

 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.

 The environment shall be ventilated.

 Do not place the analyzer on a slope.

 Connect only to a properly earth grounded outlet.

 Only use this analyzer indoors.

4.2.4.Moving and Installing the Analyzer

WARNING
 Installation by personnel not authorized or trained by Mindray may cause
personal injury or damage your analyzer. Do not install your analyzer
without the presence of Mindray-authorized personnel.

NOTE
 Before the analyzer is shipped out, the sample probe is fixed by a plastic
cable tie to avoid damaging the sample probe during transportation.
Remove the cable tie before using the analyzer.

Moving and installation of the analyzer shall be conducted by Mindray-authorized personnel.

Do not move or install your analyzer without the presence of Mindray-authorized personnel.

4-3
 Installing Your Analyzer

4.3. Connecting the Analyzer System

Connect the analyzer and the reagents as shown in the following figures. Make sure the
connections are correct and firm.

Figure 4-1 Connecting the analyzer to power outlet

4-4
 Installing Your Analyzer

Figure 4-2 Connecting the network cable

WARNING
 Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.

 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.

4-5
 Installing Your Analyzer

Figure 4-3 Connecting reagents placed outside the analyzer

4-6
 Installing Your Analyzer

Figure 4-4 Connecting reagents placed inside the analyzer

CAUTION
 Make sure the diluent pipe and waste pipe are no longer than 1500mm.

 The waste and diluent containers must be placed lower than the countertop
that accommodates the analyzer.

4-7
 Installing Your Analyzer

4.4. Notes
 The analyzer performance may be undermined if it has been placed in environment of
high dustiness.

 The surface of the analyzer shall be cleaned and sterilized regularly with alcohol (75%).

 The probe wipe block of the analyzer (see Figure 4-5 Front of the analyzer) shall be wiped
with alcohol (75%) regularly.

 Sample collection and preparation must be done following standard procedures.

 If any of the pipes or fluidic components is worn out, stop using the analyzer and contact
Mindray customer service department immediately for inspection or replacement.

 Check and make sure the reagents, lyse and waste pipes are not pressed or bent.

 You must only use the Mindray-specified reagents, otherwise the analyzer may be
damaged or provide unreliable results.

 Pay attention to the expiration dates and open-container stability days of all the reagents.
Be sure not to use expired reagents.

4-8
 5 Operating Your Analyzer
5.1. Introduction
This chapter provides step-by-step procedures for operating your analyzer on a daily basis.
A flow chart indicating the common daily operating process is presented below.

 All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

WARNING
 Do not contact the patients' sample blood directly.

 Be sure to dispose of reagents, waste, samples, consumables, etc.

5-1
 Operating Your Analyzer

according to government regulations.

 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.

 Keep your clothes, hairs and hands away from the moving parts to avoid
injury.

 The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

CAUTION
 Do not reuse disposable products such as collection tubes, test tubes,
capillary tubes and so on.

NOTE
 Use the reagents specified by the manufacturer only. Store and use the
reagents as instructed by instructions for use of the reagents.

 Check if the reagent tubes are properly connected before using the analyzer.

 Be sure to use clean EDTAK2 or EDTAK3 anticoagulant collection tubes,

fused silica glass/plastic test tubes, centrifugal tubes and borosilicate glass
capillary tubes.

 Be sure to use the evacuated collection tubes recommended in the

Appendix B.3.

 Be sure to use the Mindray-specified disposable products including

evacuated blood collection tube, anticoagulant collection tubes and
capillary tubes etc.

5-2
 Operating Your Analyzer

5.2. Initial Checks

Perform the following checks before turning on the analyzer.

 Checking the waste container

Check and make sure the waste container is not full.

 Checking reagents

Check to see if the reagents are expired or frozen. Reagents must be equilibrated for 24 hours
before use.

 Checking tubing and power connections

Check and make sure the reagents, waste and pneumatic unit tubes are properly connected
and not bent.
Check and make sure the power cord of the analyzer is properly plugged into the power
outlet.

 Checking the printer

Check and make sure enough printer paper is installed. Check and make sure the power cord
of the printer is properly plugged into power outlet, and the printer is properly connected to
the analyzer.

5-3
 Operating Your Analyzer

5.3. Startup and Logon

Start up the analyzer:

1. Change the power switch at the backside to ON position ('I') will power on the instrument.
2. The indicator light turns on.
3. The analyzer will perform self-test and initialization.

NOTE
 Time needed for initializing the fluidic systems depends on how the analyzer
was previously shut down.

 Time needed for starting up the analyzer depends on the startup sequences
run. The startup time should be within 8 minutes.

 Background check is the measurement of particle and electric interference

by the analyzer.

 If the results of the first background check do not meet requirement, the
analyzer will perform background check again.

 The sample ID of background check results is "background".

 The error message "Background abnormal" will be given when the

background results are out of range.

5-4
 Operating Your Analyzer

4. Enter the current user name and the password respectively into the "User ID" box and the
"Password" boxes.

5-5
 Operating Your Analyzer

NOTE
 If the software cannot be started successfully after being launched for
several times, contact Mindray Customer Service Department or the
authorized distributors.

 After starting up the analyzer, check if the date/time is correct.

 The default user name and password for administrator are both "Admin".

 The user name and password may consist of 1-12 letters, and the password
cannot be null.

5. Tap "Login" to enter the system.

NOTE
 If error occurs during the initialization process (e.g., background check
fails), the analyzer will report the error. See Chapter 11 Troubleshooting Your
Analyzer for the solution.

 See Appendix B Specifications for the background range of each parameter.

5-6
 Operating Your Analyzer

 The system opens different function for the user according to the user level.
The user level depends on the user name and the password when the user
logs in.

 If user switching is necessary, tap the "Logout" icon on the system menu.
Enter the desired user name and the password into the pop-up dialog box
and tap the "OK" button to log in.

 Running sample with the background abnormal error present will lead to
unreliable results.

5-7
 Operating Your Analyzer

5.4. Daily Quality Control

Perform daily quality control before running any samples. See Chapter 7 Using the QC
Programs for details.

5-8
 Operating Your Analyzer

5.5. Sample Collection and Handling

 All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

WARNING
 The sample probe is sharp and potentially biohazardous. Do not contact the
sample probe during operations.

CAUTION
 Do not reuse disposable products such as collection tubes, test tubes,
capillary tubes and so on.

NOTE
 Make sure the probe tip does not contact the sample tube to avoid potential
spillage.

5-9
 Operating Your Analyzer

1）Whole blood
sample

5.5.1 Sample 2）Capillary whole

preparation blood sample

3）Predilute sample

1）Enter sample
info.

2）Select “Whole
Blood” or
“Predilute” mode

3）Press Aspirate
5.5.2 Sample analysis key

4）Remove the
sample when hear
the beep sound

5）Run sample
analysis and report
results

1）Save the results

2）Print or transmit to
LIS
5.5.3 Processing
analysis results 3）Parameter flags

4）Flag info.

5-10
 Operating Your Analyzer

5.5.1.Sample Preparation
The analyzer can run 3 types of samples: whole blood samples, capillary whole blood
samples and pre-diluted samples.

CAUTION
 Prepare samples following the recommend procedure of the manufacturer.

 All samples shall be mixed as shown in the following figure.

1) Whole blood samples

1. Use clean EDTAK2 or EDTAK3 anticoagulant collection tubes to collect venous blood
samples.
2. Mix the sample according to your laboratory's protocol.

CAUTION
 Be sure to collect at least 0.5 mL of blood to ensure the accuracy of the
results.

2) Capillary whole blood samples

1. Use tubes to collect capillary whole blood samples.

5-11
 Operating Your Analyzer

CAUTION
 Be sure to collect at least 120uL of capillary whole blood to ensure the
accuracy of the results.

NOTE
 Be sure to run the capillary whole blood samples within 3 minutes to 2
hours after being collected.

3) Pre-diluted samples
1. Tap the diluent dispensing icon, the following dialog box pops up.

2. Present a clean tube to the sample probe, press the aspirate key to dispense diluents
(480μL). The dispensing progress bar will be displayed on the screen.
3. To continue with diluent dispensing, repeat the step 1-2.
4. Add 20μL of venous blood or capillary blood to the diluent, close the tube cap and mix it
properly according to your laboratory's protocol.
5. Tap “Cancel” after preparing all the samples, the analyzer will clean the sample probe
automatically.

5-12
 Operating Your Analyzer

NOTE
 You can also use pipette to aspirate 480μL of diluent.

 Be sure to keep dust from the prepared diluent.

 After mixing the capillary sample with the diluent, be sure to wait 3 minutes
and then remix before running the sample.

 Be sure to run the pre-diluted samples within 30 minutes after the mixing.

 Be sure to mix any sample that has been prepared for a while before running
it. Do not mix the samples with massive force using swirl mixer.

 Be sure to evaluate pre-diluted stability based on your laboratory‟s sample

population and sample collection techniques or methods.

5.5.2.Sample Analysis
Tap "Sample Analysis" to enter the sample analysis screen. Tap "Mode" button to select
"Whole blood-CBC+DIFF", "Whole blood-CBC", "Capillary whole blood-CBC+DIFF",
"Capillary whole blood-CBC", "Pre-diluted-CBC+DIFF" or "Pre-diluted-CBC" mode.

1) Enter sample information

The analyzer provides two ways for you to enter sample information: entering sample ID only
and entering all sample information.
If you want to enter sample information after analysis, you may skip this chapter, and enter
sample information at the result review screen (see Chapter 6 Reviewing Sample Results).
You may first set up the way to enter sample information at the "Setup→Auxiliary" screen as
instructed in Chapter 9 Customizing the Analyzer Software, then you may enter sample
information at the “Analysis” screen.

 Entering Patient Demographics

When the way to enter patient demographic information is set to "Enter all information", tap
"Next Sample" at the sample analysis screen, the following dialog box will display.
When the analyzer is connected to LIS, you may tap the “LIS Fetch” button to get the
complete information of the next sample.
You may enter complete information of the next sample into the dialog box. The “Ref. group”
will be selected by the system.

5-13
 Operating Your Analyzer

 Entering the sample ID

Enter the sample ID in the "Sample ID" box.

NOTE
 Letters, numerics and all characters (including special characters)
supported by the keyboard are allowed for sample ID entering.

 The allowed length of sample ID is [1, 20], and the ID cannot be null.

 Entering the medical record number

Enter the medical record number in the "Patient ID" box.

 Entering the patient name

Enter the patient name into the “Name” box.

 Selecting patient gender

Select patient gender from the "Gender" pull-down list. There are two options: "Male" and
"Female".

5-14
 Operating Your Analyzer

 Entering the date of birth

Enter the patient's date of birth into the "Date of Birth" box. Its format must be the same with
the system date format.

 Entering the patient’s age

The analyzer provides four ways for you to enter the patient’s age – in years, in months, in
days and in hours. The first way is designed for the adult or pediatric patients no younger
than one year; the second for the infant patients one month to two years; the third for the
neonatal no older than one month, and the fourth for the neonatal no older than 48 hours. You
may choose one of the four ways to enter the patient age.

NOTE
 If the patient's date of birth is entered, his/her age will be calculated
automatically, and the age field will gray out and cannot be edited.

 If the entered date of birth is later than the current system, then it is
considered invalid.

 Entering the patient type

Select patient type from the "Patient Type" pull-down list.

 Entering the department name

Enter the name of the department into the “Department” box or select it from the
"Department" pull-down list (when there are previously saved records in the list). The saved
contents will be added in the pull-down list automatically.

 Entering the bed number

Enter the number of the patient’s bed into the “Bed No.” box.

 Entering the draw time

Enter the time when the sample is collected into the “Draw Time” box.

 Entering the delivery time

Enter the delivery time of analysis into the "Delivery Time" box.

 Entering the Clinician

To enter the name of the person who sent the sample for analysis, enter the name into the

5-15
 Operating Your Analyzer

“Clinician” box or SELECT the desired name from the “Clinician” pull-down list (if there are
previously saved names in the list). The saved contents will be added in the pull-down list
automatically.

 Entering comments

Enter comments in the “Comments” box.

 OK

When you have finished entering the work list information, tap the "OK" button to save the
changes and return to the "Sample Analysis" screen.

 Cancel

If you do not want to save the entered work list information, tap the "Cancel" button to return
to the "Analysis" screen without saving the changes.

 Entering sample ID only

When the way to enter patient demographic information is set to "Enter sample ID only", tap
"Next Sample" at the sample analysis screen, the following dialog box will display.

Enter the sample ID in the "Sample ID" box. Tap "OK" to save the ID and close the dialog box,
the ID will be displayed on the screen as the next sample ID.

2) Selecting mode
Make sure the analyzer indicator is green. Select whole blood (CBC+DIFF or CBC), capillary
whole blood (CBC+DIFF or CBC), or pre-diluted (CBC+DIFF or CBC) mode based on your
needs on the mode selection screen. The selected mode will be displayed at the bottom of
the screen.

5-16
 Operating Your Analyzer

3) Aspirate sample
Present the sample to the sample probe. Press the [Aspirate] key to start the analysis.

4) Remove the sample

The sample probe will automatically aspirate sample. Remove the sample when you hear the
beep sound.

5) Auto analysis and result reporting

The analyzer will automatically run the sample. When the analysis is finished, the results will
be displayed on the screen.

5-17
 Operating Your Analyzer

Tap “RUO Screen” button, and the RUO Screen pops up as the following figure shows:

5-18
 Operating Your Analyzer

NOTE
 During the analysis process, if errors like clog or bubble occur, the analyzer
will automatically display the results of related parameters as invalid, and
alarm information will show on the error information area. See Chapter 11
Troubleshooting Your Analyzer for the way to remove errors.

 If the ambient temperature is outside the specified operating range, thus

causing the analyzer temperature (the temperature tested by the sensor
inside the analyzer) goes out its specified range, the analyzer will alarm you
for abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.

5.5.3.Processing Analysis Results

1) Automatic saving of analysis results

This analyzer automatically saves sample results. When the maximum number of results that
can be saved has been reached (100,000 records), the newest result will overwrite the
oldest.

2) Printing and Transmission to LIS

If "Auto print after sample analysis" function is enabled, the analyzer will print reports
automatically; and if "Auto Communicate" function is enabled, the analysis results, sample
and patient information will be auto transmitted to LIS.

3) Parameter flags
See the following section for details about parameter flags.

 If the parameter is followed by an “H” or “L”, it means the analysis result has exceeded
the upper or lower limit of the reference range (See Section 9.2.4 Ref. range).

 If the parameter is followed by an “R”, it means the analysis result is questionable.

 If you see “*****”, as opposed to the result, it means the result is invalid; if you see
“+++++” as opposed to the result, it means the result is out of the display range (See
Table 5-1 Display Range for details).

Table 5-1 Display Range

Parameter Display Range

WBC, Bas#, Neu#, Eos#, Mon#, Lym#, ALY#, LIC #, PLT 9
0.00 ～ 999.99×10 /L
Clumps#*, Lip#*, NRBC#*
Bas%, Neu%, Eos%, Mon%, Lym%, ALY%, LIC %, PLT 0.0 ～ 99.9 %

5-19
 Operating Your Analyzer

Clumps%*, Lip%*, NRBC%*

12
RBC 0.00 ～ 18.00 ×10 /L
HGB 0 ～ 300 g/L
HCT 0.0 ～ 80.0 %
MCV 0.0 ～ 250.0 fL
MCH 0.0 ～ 999.9 pg
MCHC 0 ～ 9999 g/L
RDW-SD 0.0 ～ 999.9 fL
RDW-CV 0.0 ～ 99.9 %
9
PLT 0 ～ 9999×10 /L
PDW 0.0 ～ 99.9
MPV 0.0 ～ 99.9 fL
PCT 0.0 ～ 0.999 %
9
P-LCC 0 ～ 9999×10 /L
P-LCR 0.0 ～ 99.9 %

4) Flags of Abnormal Blood Cell Differential or Morphology

The following table lists all flags and their indications.

Table 5-2 Flags of Abnormal Blood Cell Differential or Morphology

Flag
Flag Meaning Judgment criterion
Type
Interference of PLT clump
The DIFF and BASO channels
WBC Abnormal or NRBC to WBC count and
are unproportionate.
differential may exist:
Many scatter-points in the
Immature cells or blasts
Immature Cell? immature cell area of the
may exist
scattergram
Abnormal lymphocytes or Many scatter-points in the
Abn./Atypical
atypical lymphocytes may abnormal/ atypical lymphocytes
Lym?
exist. area of the scattergram
WBC
Possible presence of PLT Many scatter-points in the PLT
Flag PLT Clump?
clump clump area of the scattergram
Possible presence of lipid Many scatter-points in the lipid
Lipid Particles?
particles particles area of the scattergram
Many scatter-points in the NRBC
NRBC？ Possible presence of NRBC
area of the scattergram
9
Leucopenia Low WBC analysis results WBC < 2.50×10 /L
9
Leucocytosis High WBC analysis results WBC > 18.00×10 /L
Low neutrophils analysis 9
Neutropenia NEUT# < 1.00×10 /L
results

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 Operating Your Analyzer

High neutrophils analysis 9

Neutrophilia NEUT# > 11.00×10 /L
results
Low lymphocytes analysis 9
Lymphopenia LYMPH# < 0.80×10 /L
results
High lymphocytes analysis 9
Lymphocytosis LYMPH# > 4.00×10 /L
results
High monocytes analysis 9
Monocytosis MONO# > 1.50×10 /L
results
High eosinophils analysis 9
Eosinophilia EO# > 0.70×10 /L
results
High basophils analysis 9
Basophilia BASO# > 0.20×10 /L
results
9
WBC < 4.0×10 /L and RBC <
Pancytopenia WBC, RBC and PLT low 12 9
3.5×10 /L and PLT < 100×10 /L
Possible presence of
microcytes, macrocytes,
RBC Histogram The distribution of RBC
anisocytosis, RBC
Abn. histogram is abnormal
agglutination and dimorphic
histogram
HGB abnormal or RBC
RBC HGB agglutination, or MCHC > 380 g/L
Flag Abn./Interfere? interference may exist (e.g., or HGB interference
WBC high)

Microcytosis MCV low MCV < 70fL

Macrocytosis MCV high MCV > 110fL

Anemia Anemia HGB < 90g/L

12
Erythrocytosis RBC high RBC > 6.5×10 /L
Possible presence of
PLT Scattergram microcytes, red blood cell The distribution of PLT
PLT Abn. debris, giant PLT or PLT scattergram is abnormal
Flag clump
9
Thrombopenia PLT low PLT < 60×10 /L
9
Thrombocytosis PLT high PLT > 600×10 /L

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 Operating Your Analyzer

5.6. Auto-Standby
When the time for which the analyzer is free from fluidic operations reaches whatyou have set
at the "Setup" screen of the analyzer (default setting is 15 minutes), a dialog box will pop up,
prompting "Entering standby status…".

And the analyzer will prompt you to backup data.

After entering standby status, the message " Standby. Press the aspirate key to exit. " will be
displayed at the bottom left of the screen.

NOTE
 The analyzer will not enter standby status from the Status screen.

 If it is time for auto-Standby and the analyzer is reporting error, then the
error must be resolved first.

 During this condition, you can still perform any other operations (e.g.,
printing and transmission) other than fluidic operations.

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 Operating Your Analyzer

 Refer to Section 9.2.5 Maintenance Setup for how to edit waiting time before
entering standby mode.

 Under stand-by mode, if there are unfinished printing or communication

tasks, the analyzer will go on processing them.

 Aspirate key

Press the [Aspirate] key to exit the standby status.

After exiting from standby status, the dialog box above will close automatically.

NOTE
 When exiting from the standby status, the analyzer will perform different
maintenance operations based on the time consumed entering standby
status.

 If error occurs when the analyzer is exiting from the standby status, see
Chapter 11 Troubleshooting Your Analyzer for solutions.

 After exiting the standby status, the analyzer will resume its original status.
The Analysis icon will turn into solid green. And the analyzer indicator will
also turn into solid green.

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 Operating Your Analyzer

5.7. Shutdown

CAUTION
 Do not start up the analyzer immediately after it is shut down. Wait for at
least 10 seconds.

NOTE
 To ensure stable analyzer performance and accurate analysis results, be
sure to perform the "Shutdown" procedure to shut down the analyzer after it
has been running continuously for 24 hours.

Perform the shutdown procedure to shut down the analyzer daily.

1. Tap the shutdown button on the menu and the following shutdown dialog box will display.

2. Tap "OK".
3. When dialog box prompting probe cleanser maintenance displays, present probe cleanser
to the sample probe, and press [Aspirate] key. The probe will aspirate probe cleanser
automatically.
4. After shutting down finishes, the message "Please turn off the power of the analyzer!" will
be displayed. Press the Power switch on back of the instrument to power off.

WARNING
 Be sure to dispose of reagents, waste, samples, consumables, etc.
according to government regulations.

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 Operating Your Analyzer

NOTE
 Do not disconnect power during the shutdown process.

 Time needed for shutting down the analyzer depends on the shutdown
sequences run. The shutdown time should be within 10 minutes.

 If error that will affect shutdown occurs during the showdown process, the
analyzer will resume to its original status and report the error. See Chapter
11 Troubleshooting Your Analyzer for solutions.

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 6 Reviewing Sample Results

6.1. Introduction
The analyzer automatically saves analysis results. The BC-5130 can store up to 150,000
analysis results.
You can review all the analysis results, scattergrams and histograms either in table or graph
mode.

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 Reviewing Sample Results

6.2. Browsing in the "Table Review" mode

Operators can review, validate, search, edit and export saved results at the "Table Review"
screen.
Tap "Table Review" to enter the following screen.

6.2.1.Table
The table lists all analyzed samples, including basic sample information like sample ID,
sample state and so on.

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 Reviewing Sample Results

NOTE
 The table displays the latest sample results at the top.

6.2.2.Graph Review
Tap "Graph Review" button at the table review screen, or tap the "Previous" button at the
graph review screen to view the analysis results of samples.

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 Reviewing Sample Results

Other Parameters
Tap “Other Para.” button, and the “Other Para.” screen pops up. In the “Microscopic Para.”
tab, you can see the following parameters.

In the “RUO Screen” tab, you can see the following parameters.

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 Reviewing Sample Results

6.2.3.Validate/Cancel Validate (for administrators only)

 Validate sample data

Select one or more sample records, tap "validate", the sample state of the record will be
marked with "validated".

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 Reviewing Sample Results

 Cancel validate

Select one or more validated sample records, tap "Cancel validate", the "validated" marks will
disappear.

6.2.4.Delete (for administrators only)

1. Select the sample record to be deleted.
2. Tap "Delete", the following dialog box will display.

3. Tap "OK" to delete the record, and the dialog box will be closed.

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 Reviewing Sample Results

6.2.5.Edit info.
Tap the desired sample result and it will be highlighted. Tap the "Edit Info." button and the
following dialog box will display.

You may edit the sample and patient information, and tap "OK" to save the change. The
information on the table review screen will be refreshed.

6.2.6.Edit results
Tap the desired sample result and it will be highlighted. Tap the "Edit Result" button and the
following dialog box will display.

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 Reviewing Sample Results

Modify the results and tap "OK" to save the changes. The information on the graph review
screen will be refreshed.

6.2.7.Search
1. Tap "Search", the following dialog box will display.

2. Enter search conditions into the edit boxes or select them from the pull-down lists.
3. Tap "OK" to start search, the results will displayed in the table.

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 Reviewing Sample Results

6.2.8.Print
 Print reports as per the default report template

Select sample records to be printed, and then tap "Print" to print them. In the table review
interface, a “printed” mark will be applied to each printed sample in the sample state sector.

NOTE
 In sample state sector, “Validated” mark is prior to „Printed‟ mark.

6.2.9.Transmission
 Transmit selected data

1. Select samples to be transmitted at the table review screen.

2. Tap "Comm.", the following dialog box will display.

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 Reviewing Sample Results

3. Tap the "Selected" radio button.

4. Tap "OK" to start transmitting specified results to the data management software.

 Transmit all data

1. Tap "Comm.", the following dialog box will display.

2. Tap the "All" radio button.
3. Tap "OK" to start transmitting all results to the data management software.

6.2.10. Export
1 Tap "Export", the following dialog box will display.

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 Reviewing Sample Results

2 Select "Selected" or "All" in the "Export range" area.

3 Check the type of information to be exported in the "Export data" area.

6-11
 7 Using the QC Programs
7.1. Introduction
The Quality Control (QC) programs consist of strategies and procedures that measure the
precision and stability of the analyzer. The results imply the reliability of the sample results.
QC involves measuring materials with known, stable characteristics at frequent intervals.
Analysis of the results with statistical methods allows the inference that sample results are
reliable. Mindray recommends you run the QC program daily with normal level controls.
A new lot of controls should be analyzed in parallel with the current lot prior to their expiration
dates.
This may be accomplished by running the new lot of controls twice a day for five days using
any empty QC files. The QC files calculate the mean, standard deviation and coefficient of
variation for each selected parameter. The instrument-calculated means of these ten runs
should be within the expected ranges published by the manufacturer.，
This analyzer provides 2 QC programs: L-J QC and X-B QC.

 All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

WARNING
 Keep your clothes, hairs and hands away from the moving parts to avoid
injury.

 The sample may spill from the uncapped collection tubes and cause
biohazard. Exercise caution to the uncapped collection tubes.

 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.

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 Using the QC Programs

CAUTION
 Running QC sample with analyzer error will lead to unreliable results. If
errors are reported during QC analysis, remove the errors first and then
continue with the analysis.

 Do not reuse disposable products such as collection tubes, test tubes,

capillary tubes and so on.

 Sample agglutination may result in inaccurate analysis results. Check the

control samples to see if there is any agglutination, if yes, process the
samples according to your laboratory's protocols.

NOTE
 Use the controls and reagents specified by the manufacturer only. Store and
use the controls and reagents as instructed by their instructions for use.
Store and use the controls and reagents as instructed by instructions for
use of the controls and reagents.

 Refer to the instructions for use of the control for its use and storage.

 Be sure to mix any control sample that has been prepared for a while before
running it.

 Be sure to use the Mindray-specified disposable products including

evacuated blood collection tube, anticoagulant collection tubes and
capillary tubes etc.

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 Using the QC Programs

7.2. L-J QC
7.2.1.Editing L-J Settings (for administrators only)
Before running a new lot of controls, you must set up a QC file for each lot of controls.

1 Tap the menu option "QC" > "L-J QC" > "Setup".

2 Enter the L-J QC setup screen.

You may set up QC information by any of the following two ways.

 Reading the information provided by the manufacturer

 Manual Entry

Reading the information provided by the manufacturer

1. Enter the L-J QC setup screen.

2. Tap "New", or select a QC file without QC results, and then tap "Edit".
3. Tap "Import File".

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 Using the QC Programs

4. Select the QC file to be imported.

5. Tap "OK" to close the dialog box and return to the L-J QC setup screen.

6. Tap "OK" to read the selected QC information to the current QC file.

NOTE
 The "Import target/limits" check box is selected by default. If it is
deselected, the operator must enter the target and limits of QC
parameters manually.

8. Select "Control type" from the pull-down list.

9. Select the QC mode.

10 Set QC sample ID: if you are used to analyzing control together with blood samples,
you can set a unique ID for the control. The analyzer will recognize the sample as
control when it reads the unique ID. After the analysis completes, the results will be
saved into the QC file of the QC sample ID.

11 Tap other icons to switch screen and save the QC information.

Manual Entry

1. Enter the L-J QC setup screen.

2. Tap "New", or select a QC file without QC results, and then tap "Edit".

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 Using the QC Programs

3. Manually enter the lot No. of the controls in the edit box.

NOTE
 The lot No. shall not be empty and up to 16 digits can be entered.
You can enter characters, numbers, letters and special characters.

4. Select the control level.

5. Enter the expiration date of the lot.

6. Select the control type.

7. Select the QC mode.

8. Set QC sample ID: if you are used to analyzing control together with blood samples,
you can set a unique ID for the control. The analyzer will recognize the sample as
control when it reads the unique ID. After the analysis completes, the results will be
saved into the QC file of the QC sample ID.

9. Enter the target and limits in the edit boxes according to the package insert of the
same lot of controls.

10 Tap other icons to switch screen and save the QC information.

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 Using the QC Programs

Setting limits

You can adjust the format of limits as per the following procedure:
1. Tap "Set Limits".

2. Tap “By SD” to display the limits in the form of absolute value;
Or tap “By CV” to display the limits in the form of percentage.

3. Tap the “OK” button to save the settings.

7.2.2.L-J QC Run
You can select one of the two ways below to run controls:

Run controls under the "QC" screen.

Put controls together with normal samples, and run the controls under the sample analysis
screen.

Run controls under the "QC" screen

After editing the QC information, you can start QC analysis by one of the following ways
according to the selected QC mode.

 Whole blood

 Pre-diluted

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 Using the QC Programs

CAUTION
 Running QC sample with error present will lead to unreliable results. If
errors are reported during QC analysis, remove the errors first and then
continue with the analysis.

 Sample agglutination may result in inaccurate analysis results. Check the

control samples to see if there is any agglutination, if yes, process the
samples according to your laboratory's protocols.

NOTE
 When switching mode from "Pre-diluted" to "Whole Blood", a progress bar
will be displayed while the analyzer runs mode switching sequence.

1. Tap "QC" > "L-J QC" > "Count" to enter the QC count screen.

NOTE
 Be sure that the level of the control to be run is the same with the
current QC file, and the control is not expired.

 The expiration date of expired controls is displayed in red.

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 Using the QC Programs

2. Prepare the control as instructed by instructions for use of the controls.

3. Run QC analysis:
1) Make sure the analysis mode is "Whole Blood" or "Pre-diluted" and the indicator of
the analyzer is green.
2) Shake the vial of sample as instructed by instructions for use of the control to mix
the sample thoroughly.
3) Present the control sample to the sample probe. Press the [Aspirate] key to start QC
run.
4) When you hear the beep, remove the control.

4. When analysis finishes, the QC results will be displayed in the current screen and be
saved in the QC file automatically.

NOTE
 Up to 100 QC results can be saved in each QC file.

5. Do the above procedures to continue running QC analysis if necessary.

7-8
 Using the QC Programs

Put controls together with normal samples, and run the

controls under the sample analysis screen

After setting special "QC Sample ID" for a control under the QC setup screen, you can put the
control together with normal samples, and run it under the “Count” screen.

When editing worklist or entering next sample information in the "Next Sample" dialog box
before daily analysis, enter the special "QC Sample ID" as "Sample ID".

Based on the QC mode selected, you can choose to run QC analysis from one of the
following ways:

 Whole blood

 Pre-diluted

1. Prepare the control as instructed by instructions for use of the controls.

Refer to section 5.5.1 Sample Collection and Handling for sample preparation under
whole blood and pre-diluted modes.

2. When it is ready to run a sample (i.e. the status icon and the analyzer indicator is
green), present the sample to the sample probe.
3. When you hear the beep, remove the control.

4. When analysis finishes, the QC results will be displayed in the current screen and be
saved in the QC file automatically.

NOTE
 Up to 100 QC results can be saved in each QC file.

5. Do the above procedures to continue running QC analysis if necessary.

NOTE
 When switching mode from "Pre-diluted" to "Whole Blood", a progress bar
will be displayed while the analyzer runs mode switching sequence.

Editing and saving results (for administrators only)

Tap "Edit Result" on the QC screen to edit results and tap "OK" to save the edited results. The
edited results will be marked with an "E".

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 Using the QC Programs

Restore results (for administrators only)

Operators of administrator access level can restore the edited results to the original
measurement results.
1. Tap "Restore" on the edit result screen.

2. Tap "OK" to restore the measurement values.

3. Tap "OK" to close the dialog box.

7.2.3.Reviewing L-J Results

After QC analysis, you can review the QC results in the following ways:

 QC Graph

 QC Table

L-J QC graph review

1. Tap "Graph" button on the "L-J QC" screen to enter the L-J QC graph screen.

2. You can tap the arrow buttons on the right of the graph to browse graphs of the
parameters. You can tap the arrow buttons under the graph horizontally to browse all
the QC results.

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 Using the QC Programs

NOTE
 With the QC files having QC results, when you have modified and saved a
parameter target/limit, other parameter targets/limits may change
accordingly; and all those changed data will be highlighted in yellow.

Print

Tap the "Print" icon in the status bar to print information of the current QC file and the QC
graph of all parameters.

NOTE
 The green vertical line and values of the corresponding QC points will not
be printed.

L-J QC table review

1. Tap "Table" button on the "L-J QC" screen to enter the L-J QC table screen.

2. You can tap the arrow buttons on the right of the graph to browse all QC records. You
can tap the arrow buttons under the graph horizontally to browse all the parameter
results.

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 Using the QC Programs

NOTE
 With the QC files having QC results, when you have modified and saved a
parameter target/limit, other parameter targets/limits may change
accordingly; and all those changed data will be highlighted in yellow.

Delete (for administrators only)

1. Tap "Delete", the following dialog box will display.

2. Tap "Yes" to delete the selected records.

NOTE
 The operation will be recorded in the system log.

Print

You can tap the "Print" icon in the status bar to print the QC table.

Transmission

To transmit QC data to external data management software or HIS/LIS/HIS, do as follows:

1. Tap "Comm.", the following dialog box will display.

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 Using the QC Programs

2. Select to transmit "Selected" or "All" records.

3. Tap "OK" to start transmitting specified results to the data management software.

NOTE
 If “Auto Communicate” is enabled for sample results (see 9.2.1 System
Setup), and a sample is run during the transmission of the QC data, then
only when the QC data transmission finishes will the auto-communication of
the sample result start.

 The QC data saved after the QC data transmission starts will not be
transmitted in this cycle.

Export

To export QC information and results of the current QC file, do as follows:

1. Insert a USB and then tap "Export".

2 The system will detect the USB and export data automatically.

3 The prompt "Export succeeded!" will display.

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Using the QC Programs

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 Using the QC Programs

7.3. X-B QC Program

7.3.1.Introduction
The X-B analysis is a weighted moving average analysis that uses values obtained from
patient samples. It uses the 3 red cell indices, namely MCV, MCH and MCHC, to indicate the
hematology instrument performance.
It is recommended to activate the X-B analysis when the sample volume of your laboratory is
greater than 100 samples per day. Effective use of X-B requires randomization of samples
and a normal cross section of patients to prevent skewing of indices. It observes the trend of
QC results in the reference range formed by the specified target and limits.
The analyzer implement X-B QC on the 3 parameters: MCV, MCH and MCHC, each group of
samples for X-B analysis consists of 20-200 sample results obtained from normal analysis of
both WB and PD modes. The analyzer can save up to 500 X-B QC results. When the saved
QC results have reached the maximum capacity, the newest result will overwrite the oldest.

7.3.2.Editing X-B settings (for administrators only)

1. Tap the menu option "QC" - "X-B QC" - "Setup", the following screen will display.

At the X-B QC setting screen, you may activate/deactivate X-B QC, set target/limits, and
configure the sample validity setup.

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 Using the QC Programs

Editing X-B settings

1. In the “Samples /Batch” edit box, you may enter the amount of samples [within the
range 20 (default) to 200] to be included in calculating for an X-B QC point.
2. Activate/deactivate X-B QC. If X-B QC is activated, the samples meeting validity
requirements will be included in X-B QC.

Set target/limits

Before the X-B QC analysis, you shall set up the target and limit for each parameter at the
X-B QC setup screen.

NOTE
 The units of target/limits of all parameters are the same as those in the
parameter unit setup screen.

1. In the “Target/Limit” area of the X-B QC setup screen, enter the targets and limits in
the “Target/Limit” table.

NOTE
 Do not leave any of the targets and limits for the QC parameters
blank.

 When first use, the default setting will provide the initial values for
the targets and limits of all QC parameters.

2. Tap other icons to switch screen and save the settings.

Setting sample validity

In X-B QC, following sample results will be considered as invalid and cannot be used in the
QC calculation.

 Sample results exceeding the linearity range;

 Background results;

 Sample results not conforming to the "Sample Validity Setup";

 QC data for QC programs other than X-B;

 Calibration data;

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 Using the QC Programs

 Results generated while there are errors which could affect the accuracy of the
results (insufficient aspiration volume or clogging for example).

"Sample Validity Setup" is to set up the valid ranges of RBC, MCV, MCH and MCHC results.
Only when the results of all these four parameters are within the specified ranges, the sample
results can be used for X-B QC calculation. Do as follows to set the sample validity:

1. Select "On" for X-B QC to activate X-B QC.

In the "Sample Validity Setup" of the X-B QC setup screen, set the upper and lower
limits of the 4 parameters in the sample validity setup area.

The default validity range of each parameter is shown in the following figure.

2. Tap "Save" to save the setup.

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 Using the QC Programs

NOTE
 In the sample validity setup, the upper limit shall be no smaller than the
lower limit.

 The entered valid ranges of the RBC parameters should not exceed their
linearity ranges; the entered valid ranges of other parameters should not
exceed their display ranges.

 All the entries shall be numbers with only one decimal point. The length of
the number entered cannot be longer than the length of the text box.

 Once the validity range is changed, the previous results before the change
will be discarded. For example, assuming 20 valid samples are needed for
the X-B QC calculation, and you have already acquired 10 groups of valid
sample results; then you change the validity range settings. Then only valid
sample results generated afterwards will be used in the QC calculation.

 The units of lower and upper limits of all parameters are the same as those
in the parameter unit setup screen. See section 9.2.4 Setup - Parameter Unit
Setup.

Setting limits

You can adjust the format of limits as per the following procedure:
1. Tap "Set Limits".

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 Using the QC Programs

2. Tap “By SD” to display the limits in the form of absolute value;
Or tap “By CV” to display the limits in the form of percentage.

3 Tap the “OK” button to save the settings.

Restore defaults

If you want to restore the default targets and limits of the parameter, tap "Restore Defaults".
The default values of the target and limits of each parameter are as follows:

Parameter Target Limits (#)

MCV 89.5 2.7
MCH 30.5 0.9
MCHC 340 10

7.3.3.X-B QC Run
After editing X-B setup, the system will start X-B run automatically.
After every 20~200 results (determined by the setting) are obtained, the system will perform
the X-B calculation at once. You can review the result in X-B QC graph or X-B QC table.

7.3.4.Reviewing X-B Results

After QC analysis, you can review the QC results in the following ways:

 QC Graph

 QC Table

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 Using the QC Programs

X-B QC graph review

1. Tap the menu option "QC" > "X-B QC" > "Graph", the following screen will display.

2. Select QC file No., the information of the file and the QC graph will be displayed on the
screen.

3. You can tap the arrow buttons under the graph horizontally to browse all the QC results.

X-B QC table review

1. Enter the X-B QC graph screen.

2. Tap "Table" button to enter the X-B QC table screen.

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 Using the QC Programs

3. You can tap the arrow buttons on the right of the graph to browse all QC records.

The delete, print and export operations can all be performed in the same way as stated in the
L-J QC table review section.

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 8 Calibrating Your Analyzer

8.1. Introduction
Calibration is a procedure to standardize the analyzer by determining its deviation under
certain specified conditions. In order to get accurate sample analysis results, you should
calibrate the analyzer per the procedure below when necessary.
There are three calibration programs available on this analyzer: manual calibration, auto
calibration using calibrators and auto calibration using fresh blood samples.
All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be
calibrated by the calibration programs.

 All the samples, controls, calibrators, reagents, wastes and areas contacted them
are potentially biohazardous. Wear proper personal protective equipment (e.g.
gloves, lab coat, etc.) and follow safe laboratory procedures when handling them
and they contacted areas in the laboratory.

WARNING
 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and they contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.

 Keep your clothes, hairs and hands away from the moving parts to avoid
injury.

 Be sure to dispose of reagents, waste, samples, consumables, etc.

according to government regulations.

CAUTION
 Do not reuse disposable products such as collection tubes, test tubes,
capillary tubes and so on.

8-1
 Calibrating Your Analyzer

NOTE
 Be sure to use the Mindray-specified disposable products including
evacuated blood collection tube, anticoagulant collection tubes and
capillary tubes etc.

 Calibration procedures can only be performed by users of the

administrator-level.

 Use the calibrators and reagents specified by the manufacturer only. Store
and use the calibrators and reagents as instructed by their instructions for
use.

 The analyzer identifies a sample as a calibration sample only if the analysis

is started from the "Calibration" screen.

 Calculation of reproducibility is included in the calibration procedure.

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 Calibrating Your Analyzer

8.2. When to Calibrate

This analyzer is calibrated at the factory just before shipment. It is electronically stable and
does not require frequent recalibration if you operate and maintain it as instructed by this
manual. You only need to recalibrate this analyzer if:

 You are going to use this analyzer for the first time (usually done by a Mindray-authorized
representative when installing the analyzer).

 An analytical component has been changed.

 You are going to re-use the analyzer after a long-term storage.

 The quality control results indicate there may be a problem.

 The operation environment has changed significantly.

NOTE
 All of the measured parameters must be calibrated before readings of this
analyzer can be used as valid analysis results.

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 Calibrating Your Analyzer

8.3. How to Calibrate

8.3.1. Preparing Your Analyzer
Do the following pre-calibration procedures before calibration. If problems are detected during
these checks, do not attempt to calibrate the analyzer. If necessary, call Mindray Customer
Service Department or your local distributor for assistance.
1. Check and make sure enough reagents have been prepared for the calibration. You need to
start over the calibration if the reagents run out during the process.
2. Check the background (for calibration right after startup) or blank count results .If the
analyzer alarms for abnormal background results, see Chapter 11 Troubleshooting for
solutions. ( see Appendix B Specifications for the background range).
3. Run a vial of normal control consecutively for 10 times under Whole Blood -CBC+DIFF
mode. Enter the "Table" review screen to check the reproducibility of the 10th runs and make
sure they meet the following requirements.

Parameter Range Whole Blood Pre-diluted

Reproducibility Reproducibility
(CV) (CV)
9 9
WBC 4.00×10 /L～15.00 10 / L ≤ 2.0% ≤ 4.0%
3.50  10 / L ~ 6.00  10 / L
12 12
RBC ≤ 1.5% ≤3.0%
HGB 110 g/L ~ 180 g/L ≤ 1.5% ≤3.0%
MCV 70 fL～120 fL ≤ 1.0% ≤2.0%
100  10 / L ~ 149  10 / L
9 9
PLT ≤ 6.0% ≤ 10.0%
150  10 / L ~ 500  10 / L ≤4.0% ≤8.0%
9 9

4. It is recommended that you create a log table for your analyzer. This log table should
contain all necessary information that is pertinent to your analyzer. Suggested items that you
may want to include in the log table are: calibration date, supplier of calibrator, lot number,
expected results and limits, and result of background check.

NOTE
 Be sure to use the evacuated collection tubes recommended in the
Appendix.

 If fresh blood samples are used for reproducibility test, make sure the
sample volume is enough to support the test.

8.3.2. Manual Calibration

Tap "Calibration" > "Manual" in the menu to enter the following screen.

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 Calibrating Your Analyzer

NOTE
 If you log in at the operator access level, you can only view the calibration
factors. To perform calibration, please log out and then log in at the
administrator access level.

Do as follows to calibrate the analyzer.

1. At the "Manual” calibration screen, check the calibration factors and calculate the new
factors per the following equation:

old factor  reference value

new factor 
calculatedmean
For example: Suppose the WBC reference value of a calibrator is 8.4, and the current
calibration factor of the whole blood mode is 98.90％.
Run the calibrator under the whole blood mode for 10 consecutive times and take the WBC
results of the 10 runs to calculate: 8.1, 8.0, 8.1, 8.1, 8.3, 8.3, 8.2, 8.0, 8.1, 8.3. The obtained
CV is 1.5% and Mean is 8.16, which meet the requirements.
The new calibration factor is obtained:

98.90%  8.4
New factor＝ ＝101.81%
8.16
The calculated calibration factors shall be between 75.00％～125.00％. In case of an invalid

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 Calibrating Your Analyzer

calibration factor, try to find out the reason (possible reasons include, calibration material not
thoroughly mixed, mis-operation, etc.). Then re-calibrate the analyzer and re-calculate the
calibration factors.
2. Enter the new calibration factors into the factor cell of the parameter that requires
calibration.
3. When you switch screen after entering the new calibration factor, a prompt will display.

If the entered calibration factors are valid, a dialog box will display asking you to save the new
factor when you are exiting the screen. And the calibration date of the corresponding
parameter changes to current system date.

If the entered calibration factors are invalid, a dialog box will pop up prompting "Invalid entry"
when you are switching to another screen. The new calibration factor will not be saved, and
the calibration date will not be refreshed.

Other Operations

Print

Tap "Print" to print the current calibration factor.

If the calibration factors are invalid, you will not be able to print them and the dialog box "New
calibration factor is invalid." will display.

If the calibration factors are valid but not saved, a dialog box will display asking you to save the
factors.

Tap "Yes" to save and print the factors. Or tap "No" to cancel the operation without saving or
printing them.

8.3.3. Calibration with Calibrator

Tap "Calibration" > "Calibrator" in the menu to enter the following screen.

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 Calibrating Your Analyzer

NOTE
 The calibrator calibration can be performed under Whole Blood -CBC+DIFF,
Whole Blood -CBC, pre-diluted -CBC+DIFF and pre-diluted -CBC mode.

 Only Mindray-specified calibrators shall be used. Mindray will not be

responsible for any erroneous result caused by using other calibrators.

 See the instruction for use of the calibrators for the lot No., expiration date
and the targets.

 The out-of-range CV% does not influence the display of calibration factors.

Do as follows to calibrate the analyzer with calibrators.

1. Check the mode on the analyzer screen.
2. Enter the lot No. of the calibrator into the "Lot No." box.
3. Enter the “Exp. date”. 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.
4. Enter the targets into the "Target" cells.
5. Prepare the calibrator as instructed by instructions for use of the calibrators.

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 Calibrating Your Analyzer

6. Press the aspirate key to start calibration.

7. After the analysis, the analyzer will have different responses to different analysis results.

 When the current running is done, if there is a parameter whose calibration data is out of
its linearity range but still within the display range, then the calibration data will be
displayed in the list and a message box will also pop up.

Tap “OK” to close the message box, and the data will be deleted from the table without saving
automatically.

 When the running is done, if there is a parameter whose calibration data is out of the
display range, then the non-numeric parameter values "***" will be displayed in the list
and a message box will pop up.

Tap “OK” to close the message box, and the data will be deleted from the table without saving.

The valid results within the linearity range will be displayed directly. Valid calibration results will
be marked with "√” per the default setting, and will be taken to calculate calibration factors.

8. If the calibration factors have not been calculated but you switch to another screen, then a
message box will pop up.

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 Calibrating Your Analyzer

Tap "Yes" to switch to another screen while discarding the calibration data and closing the
message box. The original calibration factors remain.
9. When calibration count has been performed to a sample for n times (n≥5), the analyzer will
calculate the Mean, CV% and calibration factors of all the calibration data marked with "√"
(calibration data of the first run is not marked with "√", so it is not included in the calculation).
You can select several data to calculate the calibration factors, but only after at least 5 groups
of the data are marked with "√" can you get the calibration factors. The calibration factors will
be refreshed whenever you select “√” or deselect “√”.
When the amount of valid calibration data in the list reaches 10, a message box "Calibration is
completed!" will pop up. Then, if you press the aspirate key again, the analyzer will beep
without starting analysis.

10. There may be two cases when you are switching to another screen:

 If the calibration factors of any parameter is out of the range [75%-125%] or the CV% of
any parameter exceeds the reproducibility range, then the calculated calibration factors of
all parameters will not be saved and a message box will also pop up.

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 Calibrating Your Analyzer

Tap "Yes" to close the dialog box and switch to another screen. The calibration factors and
dates of all parameters will not be changed.

 If the calculated calibration factors of all parameter are within the range [75%-125%] and
the CV% of all parameter are also within the reproducibility range, then a message box
will pop up.

Tap "Yes" to save the new calibration factors while closing the message box and switching to
another screen.

Other Operations

Print

If the calibration factors are invalid, tap “Print”, the dialog box "New calibration factor is invalid."
will display.
If the calibration factors are valid but not saved, tap "Print", a dialog box will display asking you
to save the factors.

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 Calibrating Your Analyzer

Tap "Yes" to close the dialog box, save and print the calibration results. Or tap "No" to cancel
the operation without saving or printing them.

8.3.4. Calibration with Fresh Blood

Tap "Calibration" > "Fresh Blood" in the menu to enter the following screen.

Do as follows to calibrate the analyzer with fresh blood.

1. Prepare 3 to 5 normal fresh blood samples as instructed by 5.5.1 Preparing Samples.
2. Run each of the prepared samples on the reference instrument (or by the reference method)
five times at least. Calculate the mean values and use them as the targets. Or perform
measurement and calculation as per the reference method and take the calculated data as the
targets.
3. Select mode for fresh blood calibration, which can be Whole Blood-CBC+DIFF, Whole
Blood-CBC, Pre-diluted-CBC+DIFF and Pre-diluted-CBC.
4. Select the ID of current sample from the pull-down box "Current Sample ID".
5. Enter the targets into the "Target" cells.

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 Calibrating Your Analyzer

6. Prepare fresh blood sample.

7. Press the aspirate key to start calibration.
8. After the analysis, the analyzer will have different responses to different analysis results.

If the results are out of the linearity range but still within the display range, a dialog box will pop
up when the results are displayed in the table.

Tap “Yes” to close the message box, and the data will be deleted from the table without saving.

If the results are out of the display rage, the non-numeric parameter values "***" are obtained
and a dialog box will pop up.

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 Calibrating Your Analyzer

Tap “Yes” to close the message box, and the data will be deleted from the table without saving.
The valid results within the linearity range will be displayed directly.
Valid calibration results will be marked with "√” per the default setting, and will be taken to
calculate calibration factors.
9. When calibration count has been performed to a sample for n times (n≥5), the analyzer will
calculate the Mean, CV% and calibration factors of all the calibration data marked with "√"
automatically.
You can select several data to calculate the calibration factors, but only after at least 5 groups
of the data are marked with "√" can you get the calibration factors. The calibration factors will
be refreshed whenever you select “√” or deselect “√”.
When the amount of valid calibration data in the list reaches 10, a message box "Calibration
with the current blood sample is completed." will pop up when you start calibration again.
10. Select other calibration sample ID from the "Current Sample ID" pull-down box, analyze
other samples according to step 7-9 above to obtain the calibration factors of all samples.
11. There may be several cases when switching to another blood sample:

If the calibration factors of the blood sample are invalid or the CV% of any parameter exceeds
the reproducibility range, a dialog box will pop up when switching to another blood sample.

Tap "Yes" to empty the entered target of the current sample, all the calibration data obtained
and each calculated value including calibration factors, then close the dialog box and switch to
another blood sample.

If the calibration factors have not been calculated, a dialog box will pop up.

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 Calibrating Your Analyzer

Tap “Yes” to empty the entered target of the current sample and all the calibration data
obtained, then close the dialog box and switch to another blood sample.
If the calibration factors of the sample are valid and the CV% of all the parameters do not
exceed the reproducibility range, you can switch to another blood sample directly.
12. After calibration factors of at least 3 fresh blood samples are obtained, tap the "Calculate"
button to enter the screen of calibration calculation.

Select or deselect the calibration factors of a blood sample for the calculation of the mean
calibration factors by tapping the check boxes before the calibration factors.
When 3 or more groups of calibration factors are checked, CV% will be re-calculated
automatically based on the checked calibration factors.
When 3 or more groups of calibration factors are checked, the mean calibration factor will be
re-calculated automatically based on the checked calibration factors. The mean calibration
factors are regarded as invalid if the deviation of absolute value between the calibration factors
included in calculating the mean and the original calibration factors reaches or exceeds 5%; a
dialog box will pop up when you exit the current fresh blood calibration screen.

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 Calibrating Your Analyzer

Tap "Yes" to close the dialog box and exit with the current calibration data emptied, and then
switch to another screen.
Tap "No" to return to the current screen. Invalid mean calibration factors are followed with a "?",
and displayed in red.
13. If the mean calibration factors have not been calculated, when you exit the fresh blood
screen or switch to another calibration mode, a dialog box will pop up.

Tap "Yes" to discard the calibration data, close the dialog box, and switch to another screen or
calibration mode. The original calibration factors and date remain the same.
14. If the calculated mean calibration factors are valid, when exiting the fresh blood calibration
screen or switching to another calibration mode, a dialog box will pop up.

Tap "Yes" to save the current mean calibration factors. Then, you can switch to another screen
or calibration mode. Tap "No" to close the dialog box and switch to another screen or
calibration mode without saving the mean calibration factors and all the calibration data.

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 Calibrating Your Analyzer

Other Operations

Print

If the mean calibration factors are invalid, tap print, the dialog box "Calibration factor is invalid."
will display.
If the mean calibration factors are valid, you can tap "Print" to print the calibration factors of a
group (or more) of blood samples in table form, no matter whether they are selected ("√") or
not. The results obtained in the calibration process and the mean calibration factors can also
be printed.

8-16
 9 Customizing the Analyzer Software

9.1. Introduction
The BC-5130 is a flexible laboratory instrument that can be tailed to your working
environment. You can use the “Setup” program to customize the software options as
introduced in this chapter.
For the security of the settings and data, two access levels are provided to the operators of
the analyzer. The administrator access level provides the operator with access to more
functions or settings, some of which can be configured to be accessible to operators.

See the following figure for the setup menu.

9-1
 Customizing the Analyzer Software

9.2. Setting Up the Analyzer

9.2.1.System Setup
Date/Time
Tap the menu option "Setup" > "System Setup" > "Date/Time" to enter the "Date/Time" screen
as shown below. You can set up the date, time and date format of the analyzer at the screen.

Print
Tap the menu option "Setup" > "System Setup" > "Date/Time" to enter the "Print Setup"
screen as shown below. You can set up the following contents:

Print setup
Printing content
Auto print

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 Customizing the Analyzer Software

 Print setup

Print device

There are 2 types of printing device available: printer and recorder. You can select either of
them from the pull-down list.

Printer driver

Tap the pull-down list to select printer driver of the analyzer.

Paper

Tap the pull-down list to select the paper type of the reports to be printed.

Parameter language

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 Customizing the Analyzer Software

Tap the pull-down list to select the parameter language of the reports.

Copies
Enter the number of copies to be printed for each report into the edit box "Copies".

Report title

Report template
Applicable report templates for printer are shown as below：

Applicable report templates for recorder are shown as below.

 Printing content

You can choose to select the functions based on your needs by tapping on the check boxes.

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 Customizing the Analyzer Software

 Auto print

You can choose to disable auto print or set up printing conditions.

Communication setup
Tap the menu option "Setup" > "System Setup" > "Communication" to enter the
communication setup screen as shown below. You can set up the following contents:
Protocol Setup
Transmission Mode

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 Customizing the Analyzer Software

 Protocol Setup

Tap the "IP Address", "Subnet Mask" and "Default Gateway" edit boxes to enter the contents.

Communication Protocol
Tap the "Comm. Protocol" pull-down list to select the communication protocol.

ACK synchronous transmission

Tap on the "ACK synchronous transmission" check box to activate the function.
When the function is activated, ACK overtime is 10 seconds by default. You can re-enter the
ACK overtime is the edit box.

 Transmission Mode

You can choose to select the functions based on your needs by tapping on the check boxes.

 Auto retransmit

 Auto Communicate

 Auto Fetch Info from LIS

 Transmit as Print Bitmap Data

Transmission mode of histogram and scattergram

Tap the pull-down lists to select the transmission modes of histogram and scattergram.

 Not to be transmitted

 Bitmap

 Data

Flag alarm sensitivity

Tap the menu option "Setup" > "System Setup" > "Flag alarm sensitivity" to enter the screen
as shown below. This function allows you to set up flag alarm sensitivity based on your own
needs.

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 Customizing the Analyzer Software

This screen shows the values that may trigger flag alarm. Operators of administrator access
level can modify the reference values of the flags, which indicated the possibility of triggering
flags. The lower the values are, the higher the possibility can be.

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 Customizing the Analyzer Software

Shortcut code setup

Tap the menu option "Setup" > "System Setup" > "Shortcut Code Setup" to enter the screen
as shown below. This function allows you to set up shortcut codes for the contents in sample
information setup screens.

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 Customizing the Analyzer Software

 Add shortcut codes

1. Select "Department" or "Clinician" tab.

2. Tap "Add", a line will be added in the table.
3. Enter the "Name", "Shortcut Code" and "Digital Code" based on your needs.

 Edit shortcut codes

1. Select "Department" or "Clinician" tab.

2. Select the line of the shortcut code to be edited.
3. Modify it directly in the table.

 Delete shortcut codes

1. Tap the shortcut code to be deleted.

2. Select the line of the shortcut code to be deleted.
3. Tap "Delete" to delete it.

Lab info. setup

Tap the menu option "Setup" > "System Setup" > "Lab Info. Setup" to enter the screen as
shown below. Operators may enter, save and view lab information. Tap on the edit boxes to
enter the information.

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 Customizing the Analyzer Software

NOTE
 The analyzer SN cannot be edited.

 The date of installation is the date the analyzer is installed by default. It can
be edited, but cannot be later than the current system date.

9.2.2.Access Setup
Tap "Setup" > "Access Setup" in the menu to enter the following screen.

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 Customizing the Analyzer Software

 Modify password

You can modify your own password.

1. Select the current user, and then tap "Modify password", the following dialog box will
display.

2. Enter the required information in the edit boxes.

3. Tap "OK" to save the change and close the dialog box.

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 Customizing the Analyzer Software

NOTE
 The password cannot be null, and 12 characters can be entered at most.

 Create new user

1. Tap "New", the following dialog box displays.

2. Enter the "User ID", "Name" and "Password" information.

3. Select access level of the user:
 Operator
 Administrator
4. Tap "OK" to save the change and close the dialog box.

NOTE
 The user ID cannot be null, and 12 characters can be entered at most.

 The password cannot be null, and 12 characters can be entered at most.

 The name cannot be null, and 20 characters can be entered at most.

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 Customizing the Analyzer Software

 Delete user

Select a user and then tap "Delete" to delete it.

NOTE
 The current login user cannot be deleted.

9.2.3.Auxiliary Setup
Tap "Setup" > "Auxiliary Setup" in the menu to enter the following screen. You can set up the
following contents:
Setting of the next sample
Setting of the first sample after startup
Other settings

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 Customizing the Analyzer Software

 Setting of the next sample

Entry of the next sample ID

Tap the pull-down list to select the way to enter the next sample ID.
 Auto Increase
 Manual Entry

Not counted as an auto increase character

Operators can set up the number of characters in the sample ID that will not be auto
increased.
When "Auto Increase" is selected as the way to enter the next sample ID, this edit box will be
activated.
Enter a number n into the edit box. The first n characters in the sample ID will not be auto
increased.

 Setting of the first sample after startup

Operators may:
Customize the first sample ID after startup by entering it into the edit box. Or select to
continue with the sample ID before last shutdown.

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 Customizing the Analyzer Software

 Other settings

On/Off radio buttons

Select "On" or "Off" to activate or deactivate the functions.

Flags
Operators may set up the suspect flag by entering a character into the edit box, or selecting a
letter from the pull-down list (the default character is "R").

Operators may set up the high/low flag by entering two characters into the edit boxes, or
selecting two letters from the pull-down lists (the default character of high flag is "H", and that
of low flag is "L").

9.2.4.Parameter Setup
Parameter unit setup
Tap the menu option "Setup" > "System Setup" > "Reference Unit Setup" to enter the screen
as shown below. You can set up parameter unit at this screen.

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 Customizing the Analyzer Software

 Select unit system

Tap the "Unit system" pull-down list to select unit system.

 Customizing parameter units

Under each unit system, you can tap the "Unit" cell to customize the parameter unit.
Tap the "Default" button to restore the default units.

NOTE
 The units displayed will be different when different unit system is selected.

Reference range setup

Tap the menu option "Setup" > "System Setup" > "Reference Range Setup" to enter the
screen as shown below. 5 factory reference groups and 10 customized reference groups are
provided for your choice. Each laboratory shall select a proper reference range of its own
based on its patient demographics. The reference range differs among races, genders, ages
and geographic locations.

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 Customizing the Analyzer Software

 Customizing reference groups

Select a reference group and tap "New" or "Edit" to enter the reference group setup screen.
You can set up the name, lower and upper limits of age and parameter range.

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 Customizing the Analyzer Software

Tap the "Set to Default" button, the reference ranges of the selected factory reference group
can be restored to the default settings.

NOTE
 The name of the reference group cannot be null.

 The names of the customized reference groups shall not repeat the names
of the 5 default groups, and they shall not repeat each other either.

 Setting as default reference group

Select a reference group and then tap "Set to Default" to set it as default reference group.

NOTE
 The name, lower and upper limits of age and gender of the factory reference
groups cannot be modified.

 The input range of age is [0,999].

 Modify reference range(s)

To modify the reference range of a reference group, select the group from the reference
group list on the left, and then tap the cells of upper and lower limits in the table and re-enter
the values.
To restore the reference ranges to default, tap the “Default” button on top right of the screen.

When "Match customized ref. group first" is selected, if the age ranges of the customized
reference group and the default reference group contradicts with each other, the customized
reference group will be matched first on the sample analysis and review screens.

Microscopic parameter setup

Tap the menu option "Setup" > "System Setup" > "Microscopic Para. Setup" to enter the
screen as shown below. You may modify microscopic parameter related settings.

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 Customizing the Analyzer Software

 Add new parameter

Tap the “New” button to add a new row in the table, and then you can enter the name of the
parameter in the row.

 Delete

Select a row in the table, tap the “Delete” button to delete the parameter.

 Editing parameter name

Tap a parameter name in the table to edit the name.

NOTE
 You can add up to 40 microscopic parameters.

 The reconfigured setup will not be applied to sample records which already
have microscopic results saved, but only applied to sample records with
unsaved microscopic results and records attained after the new setup is
applied.

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 Customizing the Analyzer Software

9.2.5.Maintenance Setup (for administrators only)

Tap "Setup" > "Maintenance" in the menu to enter the following screen. You can set up the
following contents:

Standby
Tap the text box "Wait" and enter the waiting time before entering the standby status. The
range allowed is 10 -30 minutes, and the default setting is 15 minutes.

Probe cleanser maintenance

Tap the first text box in the "Probe Cleanser Maintenance" area to enter the time to start
time-based probe cleanser maintenance. Tap the second text box to enter a time in the text
box. Then when the operator cancels the time-based maintenance, a reminder dialog box will
pop up after the defined minutes.

9.2.6.Reagent Setup
Tap "Setup" > "Reagent Setup" in the menu to enter the following screen.

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 Customizing the Analyzer Software

It is recommended that you replace the reagents when their residue volume icons turn from
BLUE to RED.
This function may also be used to refill reagent inside the fluidic system when a new
container of reagent is loaded.

NOTE
 The reagents must be kept still for at least for a day after long-term
transportation.

 When you have changed the diluents or lyse, run a background test to see if
the results meet the requirement.

You should replace reagents when:

 the reagent runs out and a new container of reagent is installed.

 the reagent in the tubing is contaminated.

 there are bubbles in the tubing.

You can replace the following reagents in the fluidics:

 Diluent

 DIFF lyse

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 Customizing the Analyzer Software

 LH lyse

 Do as follows to replace the reagents.

1. Tap the reagent you want to replace, and then tap "Setup".

2 Enter reagent information at the screen.

Or scan in the barcode. If the barcode is valid, the corresponding reagent information
will automatically display.
3 Tap "Replace" to save the expiration date and start to replace the reagent. A
progress bar will be displayed in the process.
4 Replace other reagents as per the above procedures if needed.

NOTE
 Please keep the diluent container from severe shock or crashing against
other object. Otherwise, the alarming would be unreliable.

 When replacing diluent container, do as follows: 1) Install the supporting

board under the cap of the diluent container as instructed below. 2) Insert
the diluent cap assembly into the container as shown in the figure below,
and tighten the cap. Otherwise the alarming may be unreliable.

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 Customizing the Analyzer Software

9.2.7.Gain Setup (for administrators only)

Tap "Setup" > "Gain Setup" in the menu to enter the following screen. Gain setup function
allows you to adjust the digital potentiometers. The operation shall not be performed
frequently.

 RBC gain

Tap the MCV-G "Set Value" cell, and enter the new value of RBC gain.

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 Customizing the Analyzer Software

 HGB gain

The purpose of adjusting HGB gain is to change HGB background voltage.

Tap the "Auto Cal. to 4.2V" button, and the HGB blank voltage will be set to 4.2V
automatically.

NOTE
 The gains of LAS, MAS and WAS cannot be modified.

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 Customizing the Analyzer Software

9.3. Save the settings

To save the modified settings, you may switch to another screen, the following dialog box will
display.

Tap "Yes" to save the settings and switch to the corresponding screen. Tap "No" to switch to
the corresponding screen without saving the settings.

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 10 Servicing Your Analyzer
10.1. Introduction
Preventive and corrective maintenance procedures are required to keep the analyzer in a
good operating condition. This analyzer provides multiple maintenance functions for this
purpose.
This chapter introduces how to use the provided functions to maintain and troubleshoot your
analyzer.

 All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.

WARNING
 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.

 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.

CAUTION
 Improper maintenance may damage the analyzer. Operators must follow the
instruction of this Operator's Manual to perform maintenance operations.

 For any questions, contact Mindray customer service department.

 Only Mindray-supplied parts can be used for maintenance. For any

questions, contact Mindray customer service department.

 Exercise caution to avoid contact with the sharp sample probe when
performing maintenance.

The following table lists the tools that may be used in maintenance.
No. Tools
1. Cross-headed screwdriver
2. Slotted head screwdriver
3. Medical gloves
4. Alcohol

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 Servicing Your Analyzer

10.2. Maintaining Your Analyzer

Maintenance options of the analyzer includes: maintenance, cleaning and fluidics
maintenance.

10.2.1. Maintenance
Tap "Service" > "Maintenance", and select the "Maintenance" tab to enter the following
screen.

Unclog aperture

Unclogging includes zapping and flushing the aperture. When clog error us reported, you
should unclog the aperture.
The unclogging procedures are:
1. Tap the "Unclog" button to start unclogging.
2. When the progress ends, a message will display indicating "Maintaining finished!".
3. Do the above procedures to continue unclogging aperture if necessary. If the error
persists, perform probe cleanser maintenance of the related channels.

Probe cleanser maintenance

You should perform the probe cleanser soaking procedure when:

 background results are out of range;

10-2
 Servicing Your Analyzer

 QC results or scattergrams abnormal due to long term idleness of the analyzer;

 or when other maintenance operations fail to solve the clog error;

 when analyzer shuts down due to abnormal power break-off; probe cleanser
maintenance must be performed after it is started up again.

The probe cleanser maintenance procedures are:

1. Tap "Overall Soak" button, the following dialog box will display.

2. Tap "Yes", the analyzer starts to prepare for the maintenance.

3. When the preparation is done, the following dialog box will display.

4. After aspirating probe cleanser, the analyzer performs probe cleanser soak
automatically, and a progress bar will display indicating the progress.

5. When the progress ends, the following dialog box will display, tap “OK” to close the
dialog box.

10-3
 Servicing Your Analyzer

10.2.2. Cleaning
You should clean the following components when:

 WBC and (or) HGB background results exceed their limits, perform WBC bath cleaning.
If WBC bath cleaning does not solve the problem, perform WBC probe cleanser
maintenance.

 RBC and (or) PLT background results exceed their limits, perform RBC bath cleaning. If
RBC bath cleaning does not solve the problem, perform RBC probe cleanser
maintenance.

 there are too many particles in the scattergram of background results, perform WBC
bath cleaning. If WBC bath cleaning does not solve the problem, perform WBC probe
cleanser maintenance.

 sample probe gets dirty, perform sample probe cleaning.

Tap "Service" > "Maintenance", and select the "Cleaning" tab to enter the following screen.

10-4
 Servicing Your Analyzer

You may perform cleaning operation to the following components:

 Fluidics

 Flow cell

 Sample probe

 Unclog flow cell

 WBC bath

 RBC bath

The cleaning procedures are:

1. Tap the button of the component you want to clean. The message "Cleaning in
process. Please wait..." will display.
2. When the progress ends, a message will display indicating "Cleaning finished!".
3. Clean other components as per the above procedures if needed.

10.2.3. Servicing the Fluidics

 Tap "Maintenance", and select the "Fluidics" tab to enter the following screen.

10-5
 Servicing Your Analyzer

Pack-up

If the analyzer is not to be used for over 2 weeks, you should perform this procedure.
Do as follows to pack up:
1. Tap "Pack-up", the dialog box "Start pack-up?" will pop up.
2. Tap "Yes" to perform the pack-up procedure. The following dialog box will display.

3. Take out the tubes as instructed and then tap "OK" to drain the fluidics.

10-6
 Servicing Your Analyzer

4. The following dialog box will display after draining the fluidics.

5. Put the tubes into distilled water as instructed, and tap "OK" to start priming.

6. When the priming progress ends, the following dialog box will be displayed.

7. Take out the tubes as instructed and then tap "OK" to drain the fluidics again.

10-7
 Servicing Your Analyzer

8. The following dialog box will be displayed after draining the fluidics.

9. When the pack-up is finished, shut down the analyzer as prompted.

NOTE
 This software can still be used after the pack-up.

Reset

When major components of the analyzer have been replaced, or the fluidic system has been
serviced, you must reset the fluidics.

Do as instructed below:
1. Tap "Reset Fluidics", a dialog box will pop up asking you to confirm the operation.
2. Tap "OK" to start initialization, the message "Resetting fluidics. Please wait..." will be
displayed.
3. When the progress ends, a dialog box will display indicating “Resetting fluidics
finished!”.
4. Do the above procedures to continue resetting fluidics if necessary.

10-8
 Servicing Your Analyzer

10.3. Touch Screen Calibration

Tap "Maintenance" > "Calibrate Touchscreen" in the menu to enter the following screen.

10-9
 Servicing Your Analyzer

10.4. Viewing Logs

Tap "Maintenance" > "Log" in the menu to enter the following screen.

You may view the error info., parameter modification info. and records of daily operation in
the log.
The “Log” screen records all activities of the analyzer. It contributes significantly to searching
for operation history and troubleshooting the analyzer.

NOTE
 The oldest record will be overwritten automatically when number of log
records reaches the utmost.

 Records of two years can be stored at most.

Exporting logs
1. Tap "Export", the following dialog box will display.

10-10
 Servicing Your Analyzer

2. Select the range of the logs that you want to export.

3. Tap "OK" to close the dialog box and export the logs.

10-11
 Servicing Your Analyzer

10.5. Checking the Analyzer Status

NOTE
 If the status is outside normal range, it will be highlighted with red
background.

10.5.1. Counter
The counter counts the running times of the analyzer and the occurrence times of some
major parameters.

 Viewing details

You may tap the "Detail..." buttons following "Runs", "QC Runs" or "Calibration Runs" to view
the related details.

 Print

Tap the "Print" icon to print all information on the screen.

10-12
 Servicing Your Analyzer

10.5.2. Temp. & Pressure

Tap "Status" > "Temp. & Pressure" in the menu to enter the following screen. You may check,
export or print the temperature and pressure values of different components of the analyzer.

10-13
 Servicing Your Analyzer

10.5.3. Voltage and Current

Tap "Status" > "Voltage & Current" in the menu to enter the following screen.
You may check the Voltage and Current values of different components of the analyzer.

10-14
 Servicing Your Analyzer

10.5.4. Sensor
Tap "Status" > "Sensor" in the menu to enter the following screen.
You may check the sensor status of the analyzer.

10-15
 Servicing Your Analyzer

10.5.5. Version Info.

Tap "Status" > "Version Info." in the menu to enter the following screen. You may view the
current version information of the analyzer.

10-16
 11 Troubleshooting Your Analyzer

11.1. Introduction
This chapter contains information that is helpful in locating and correcting problems that may
occur during operation of your analyzer.

NOTE
 This chapter is not a complete service manual and is limited to problems
that are readily diagnosed and/or corrected by the user of the analyzer.

11-1
 Troubleshooting Your Analyzer

11.2. Error Information and Handling

During the operation, if error(s) is(are) detected, the analyzer will beep and display the
corresponding error message in the error information area at the bottom right of the screen.
Meanwhile, the indicator will turn red.
According to the severity of the errors, the colors of error messages are red, orange, blue and
green.

 Red: fatal error. When this kind of error occurs, the analyzer will stop running
immediately, and any further operation is prohibited.

 Orange: error that stops operation. When this kind of error occurs, the analyzer will stop
running immediately.

 Blue: error that restricts certain operations. When this kind of error occurs, the analyzer
can still continue with the current operation, but any other operations related to the error
will be restricted.

The following Figure is the error info. dialog box.

The name and troubleshooting method of the errors are displayed. Names of the errors are
displayed by the order of their occurrence.
You may tap to select the error, and view its troubleshooting information in the
troubleshooting box. The troubleshooting information of the first error is displayed by default.
Please follow the troubleshooting to resolve the error by sequence.

11-2
 Troubleshooting Your Analyzer

The following functions are provided:

 Remove error

Tap the "Remove Error" button to clear all the errors that can be removed automatically. For
the errors that cannot be removed automatically, follow the troubleshooting method to solve
them.

 Close the error info. dialog box

Tap "Close" to close the dialog box, but the errors will still be displayed in the error info. area
on the screen. Tap the error info. area again, the dialog box will be displayed.

The possible error(s) and the corresponding troubleshooting information are listed below:

Error Name Actions

1. Tap “Remove Error” to see if the error can be removed.
Communication error 2. If the error still exists, contact our customer service
department.
1. Power off the analyzer directly, and then contact our
Digital board error
customer service department.
1. Power off the analyzer directly, and then contact our
System clock error
customer service department.
1. please modify the IP address in the interface of
IP address collision
communication settings
1. Tap "Remove Error", and enter the new barcode of the
diluent into the reagent setup dialog box.
2. After replacing the diluent container, tap "Apply" to prime
Diluent ran out
diluent.
3. If the error still exists after replacing the diluent, contact
our customer service department.
1. Tap "Remove Error", and enter the new barcode of the
LH lyse into the reagent setup dialog box.
2. After replacing the lyse container, tap "Apply" to prime
LH lyse ran out
the lyse.
3. If the error still exists after replacing the lyse, contact our
customer service department.
1. Tap "Remove Error", and enter the new barcode of the
DIFF lyse into the reagent setup dialog box.
2. After replacing the lyse container, tap "Apply" to prime
DIFF lyse ran out
the lyse.
3. If the error still exists after replacing the lyse, contact our
customer service department.
1. Tap "Remove Error", and enter the new barcode of the
Diluent expired LH lyse into the reagent setup dialog box.
2. After replacing the lyse container, tap "Apply" to prime

11-3
 Troubleshooting Your Analyzer

the lyse.
3. If the error still exists after replacing the lyse, contact our
customer service department.
1. Tap "Remove Error", and enter the new barcode of the
LH lyse into the reagent setup dialog box.
2. After replacing the lyse container, tap "Apply" to prime
LH lyse expired
the lyse.
3. If the error still exists after replacing the lyse, contact our
customer service department.
1. Tap "Remove Error", and enter the new barcode of the
DIFF lyse into the reagent setup dialog box.
2. After replacing the lyse container, tap "Apply" to prime
DIFF lyse expired
the lyse.
3. If the error still exists after replacing the lyse, contact our
customer service department.
Empty the waste container or use a new waste container.
2. Tap “Remove Error” to see if the error can be removed.
Waste container full
3. If the error still exists, contact our customer service
department.
1. Power off the analyzer directly, and then contact our
Power source error
customer service department.
1. Power off the analyzer directly, and then contact our
Temperature sensor error
customer service department.
1. Power off the analyzer directly, and then contact our
Preheat assembly error
customer service department.
1. Power off the analyzer directly, and then contact our
Laser error
customer service department.
1. Tap “Remove Error” to see if the error can be removed.
Syringe module error 2. If the error still exists, contact our customer service
department.
1. Tap “Remove Error” to see if the error can be removed.
Aspiration module lift
2. If the error still exists, contact our customer service
mechanism error
department.
1. Tap “Remove Error” to see if the error can be removed.
Aspiration module rotary
2. If the error still exists, contact our customer service
mechanism error
department.
1. Tap “Remove Error” to see if the error can be removed.
Background abnormal 2. If the error still exists, contact our customer service
department.
1. Tap “Remove Error” to see if the error can be removed.
Exiting standby mode failed 2. If the error still exists, contact our customer service
department.
1. Tap “Remove Error” to see if the error can be removed.
Replacing diluent failed
2. If the error still exists, contact our customer service

11-4
 Troubleshooting Your Analyzer

department.
1. Tap “Remove Error” to see if the error can be removed.
Replacing DIFF lyse failed 2. If the error still exists, contact our customer service
department.
1. Tap “Remove Error” to see if the error can be removed.
Replacing LH lyse failed 2. If the error still exists, contact our customer service
department.
1. Check if there is diluent reagent in the container. If not,
replace the container with a new one.
HGB blank voltage abnormal 2. Tap "Remove Error" to remove the error.
3. If the error persists, contact our customer service
department.
1.Please do "Probe Cleanser Maintenance".
2.Please do "Clear Flow Cell".
3. Power off the analyzer directly, and restart it after a
Liquid pressure overloaded
while.
4. If the error persists, contact our customer service
department.
1. Tap “Remove Error” to see if the error can be removed.
Vacuum pressure abnormal 2. If the error still exists, contact our customer service
department.
1. Tap “Remove Error” to see if the error can be removed.
Preheat bath temperature
2. If the error still exists, contact our customer service
error
department.
1. The ambient temperature shall be within [10℃, 30℃]
Machine temperature too high 2. Diluent temperature shall be within [10℃, 30℃].
3. Tap “Remove Error” to see if the error can be removed.
Diluent temperature is too 1. Diluent temperature shall be within [10℃, 30℃].
high
Diluent temperature is too low 1. Diluent temperature shall be within [10℃, 30℃].
1. Tap “Remove Error” to see if the error can be removed.
Clogging 2. If the error still exists, contact our customer service
department.
1. Tap “Remove Error” to see if the error can be removed.
Aperture voltage abnormal 2. If the error still exists, contact our customer service
department.
Impedance channel signal 1. Please eliminate sources of interference.
abnormal 2. Tap “Remove Error” to see if the error can be removed.
1. Tap "Remove Error" button to remove the error.
2. If the error persists, power off the analyzer and power on
Analysis is abnormal later.
3. If the error persists, contact our customer service
department.
RBC channel is abnormal 1. Please check the analysis mode.

11-5
 Troubleshooting Your Analyzer

2. Tap "Remove Error" button to remove the error.

3. If the error persists, power off the analyzer and power on
later.
4. If the error persists, contact our customer service
department.
1. Please check the DIFF lyse residue and the analysis
mode.
2. Tap "Remove Error" button to remove the error.
DIFF channel is abnormal 3. If the error persists, power off the analyzer and power on
later.
4. If the error persists, contact our customer service
department.
1. Please check the LH lyse residue and the analysis
mode.
2. Tap "Remove Error" button to remove the error.
BASO channel is abnormal 3. If the error persists, power off the analyzer and power on
later.
4. If the error persists, contact our customer service
department.
Abnormal liquid pressure fluctuation. Check if the diluent
Abnormal liquid pressure
has run out
Abnormal HGB blank voltage. Check if the diluent has run
Abnormal HGB blank voltage
out
Abnormal mean liquid pressure. Check if the diluent has
run out. Perform “Valve Self-test” to check the status of all
Abnormal liquid pressure
valves. Check if the if the liquid pressure sensor work
normally

11-6
 12 Appendices

A. Index
Analysis, 5-13 Logs, 10-10
Aspiration, 3-2 maintenance, 10-1
Auto-Sleep, 5-22 Manual Calibration, 8-4
buzzer, 2-11 Parameter flags, 5-19
Calibration, 8-1 Parameters, 2-2
calibrators, 2-14 Prediluted samples, 5-12
Capillary whole blood samples, 5-11 Quality Control, 7-1
Colorimetric Method, 3-6 Reagents, 2-13
controls, 2-14 Setup, 9-1
Dilution, 3-3 Shutdown, 5-24
Electrical Impedance Method, 3-7 software, 1-2
Flow Cytometry by Laser, 3-5 Startup, 5-4
Graph Review, 6-3 Table Review, 6-2
hardware, 1-2 Touch Screen Calibration, 10-9
Initial Checks, 5-3 Transmission, 6-9
Installation, 4-2 troubleshooting, 11-2
Logon, 5-4 Whole blood samples, 5-11

A-1
B. Specifications
B.1. Classification
According to the CE classification, the BC-5130 belongs to In vitro diagnostic medical devices
other than those covered by Annex II and devices for performance evaluation.

B.2. Reagents
Name Model

Diluent M-52D

Lyse M-52DIFF
M-52LH
Probe Cleanser /

B.3. Applicable Tubes

The following tubes can be used:
Ф12～15×75mm evacuated collection tube (without cap) for whole blood mode
Ф11×40mm (1.5ml centrifugal tube) and 0.5ml centrifugal tube for pre-dilute and capillary
whole blood mode.
Ф10.7×42mm small closed anticoagulated tube (without cap), 0.5ml, can be used with cap
opened, for capillary whole blood mode. Recommended tube: No. 365974 closed
anticoagulated tube (0.5ml) manufactured by BD.

B.4. Parameters
Parameter Abbreviation Default Unit
9
White Blood Cell count WBC 10 /L
9
Basophils number Bas# 10 /L
Basophils percentage Bas% %
9
Neutrophils number Neu# 10 /L
Neutrophils percentage Neu% %
9
Eosinophils number Eos# 10 /L
Eosinophils percentage Eos% %
9
Lymphocytes number Lym# 10 /L
Lymphocytes percentage Lym% %
9
Monocytes number Mon# 10 /L
Monocytes percentage Mon# %
9
Abnormal Lymphocyte number ALY# (RUO parameter) 10 /L

Abnormal Lymphocytes
percentage ALY% (RUO parameter) %

B-1
 Specifications

9
Large Immature Cell number LIC# (RUO parameter) 10 /L
Large Immature Cell percentage LIC% (RUO parameter) %
9
Platelet clump number PLT Clumps#(RUO parameter) 10 /L
Platelet clump percentage PLT Clumps%(RUO parameter) %
Lipid granule number Lip#(RUO parameter) 109 / L
Lipid granule percentage Lip%(RUO parameter) %
Nucleated red blood cell (NRBC)
number NRBC#(RUO parameter) 109 / L
Nucleated red blood cell (NRBC)
percentage NRBC%(RUO parameter) %
12
Red Blood Cell count RBC 10 /L
Hemoglobin Concentration HGB g/L
Mean Corpuscular Volume MCV fL
Mean Corpuscular Hemoglobin MCH pg
Mean Corpuscular Hemoglobin MCHC g/L
Red BloodConcentration
Cell Distribution Width RDW-CV %
Coefficient
Red Blood of VariationWidth
Cell Distribution RDW-SD fL
Standard Deviation
Hematocrit HCT %
9
Platelet count PLT 10 /L
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW None
Plateletcrit PCT %
Platelet-Large Cell Ratio P-LCR %
9
Platelet Larger Cell Count P-LCC 10 /L
White blood Cell Histogram WBC Histogram None
Red blood Cell Histogram RBC Histogram None
Platelet Histogram PLT Histogram None
Differential Scattergram Diff Scattergram None

B.5. Sampling Features

B.5.1. Sample Volumes Required for Each Analysis

Whole blood and capillary
≤15ul under both CBC and CBC+DIFF modes
whole blood mode

Pre-diluted mode ≤20ul under both CBC and CBC+DIFF modes

B.5.2. Throughput
Open vial-whole blood, open vial-pre-diluted and open vial-capillary whole blood modes: no
less than 60 samples per hour

B-2
 Specifications

B.6. Performance Specifications

B.6.1. Display Range
Parameter Display range
9 9
WBC 0.00×10 /L～999.99×10 /L
12 12
RBC 0.00×10 /L～18.00×10 /L

HGB 0 g/L～300g/L
9 9
PLT 0×10 /L～9999×10 /L

HCT 0%~80%

B.6.2. Background/Blank Count

Parameter Background/blank count requirements
9
WBC ≤ 0.2010 / L
12
RBC ≤ 0.02 10 / L
HGB ≤1g/L

HCT ≤ 0.5 %

≤ 10  10 / L
9
PLT

B.6.3. Linearity Range

Parameter Linearity Range Deviation Range Deviation Range
(Whole Blood) (Pre-diluted)
9 9 9
WBC 0.00×10 /L ～ ±0.30×10 /L or ±5％ ±0.60×10 /L or ±6%
9
100.00×10 /L
9
100.01×10 /L ～ ±10% ±12%
9
500.00×10 /L
12 12 12
RBC 0.00×10 /L ～ ±0.05×10 /L or ±5% ±0.10×10 /L or ±10%
12
8.00×10 /L

HGB 0 g/L～250g/L ±2g/L or±2％ ±4g/L or±4%

9 9 9 9
PLT 0×10 /L～1000×10 /L ±10×10 /L or ±8% ±20×10 /L or ±16%
9
1001×10 /L ～ ±12% ±20%
9
5000×10 /L

B.6.4. Deviation of Reading

Parameter Deviation of Reading
WBC ≤±10％

B-3
 Specifications

RBC ≤±6%
HGB ≤±7%
PLT ≤±15%

B.6.5. Compatibility
Deviation ranges: WBC ≤± 5%, RBC ≤±2%, HGB ≤±2%, PLT ≤±8%, HCT/MCV ≤±3%.

B.6.6. Reproducibility

Parameter Condition Whole Blood Pre-diluted

Reproducibility Reproducibility
(CV/absolute (CV/absolute
deviation d) deviation d)
9 9
WBC 4.00×10 /L～15.00 10 / 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  10 / L ~ 6.00  10 / L
12 12
RBC ≤1.5% ≤3.0%
HGB 110 g/L ~ 180 g/L ≤1.5% ≤3.0%
MCV 70 fL～120 fL ≤1.0% ≤2.0%
100  10 / L ~ 149  10 / L
9 9
≤6.0% ≤10.0%
PLT
150  10 / L ~ 500  10 / L
9 9
≤4.0% ≤8.0%
MPV / ≤4.0% ≤8.0%

B.6.7. Carryover
Parameter Carryover
WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.6%
HCT ≤0.5%
PLT ≤1.0%

B.7. Input/Output Device

WARNING
 Be sure to use the specified devices only.

B-4
 Specifications

NOTE
 If the analyzer is to be connected with LIS, the PC must be configured with
dual network cards.

B.7.1. External Computer (optional)

Recommended PC configurations: CPU Intel® 1.6GHz and above

RAM: 1G or above

Hard disk: 160GB or above

Recommended resolution of the display1280*1024(standard), 1680*1050 (wide screen)

Operating system: Microsoft Windows 7 or above, with DVD-ROM.

B.7.2. Keyboard (Optional)

101-Key alpha-numeric keyboard

B.7.3. Mouse (Optional)

B.7.4. External Barcode Scanner (Optional)

B.7.5. Printer (Optional)

B.8. Interfaces
4 USB ports

B.9. Power Supply

Voltage Input power Frequency

Analyzer (100V-240V～)±10% ≤300 VA (50Hz/60Hz)±1Hz

B.10. FUSE

WARNING
 Use specified fuse only.

Fuse specification: 250V T3.15AH

B-5
 Specifications

B.11. EMC Description

 Do not use this device in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper operation.

 This equipment complies with the emission and immunity requirements of the EN
61326-1:2013 and EN 61326-2-6:2013.

NOTE
 It is the manufacturer's responsibility to provide equipment electromagnetic
compatibility information to the customer or user.

 It is the user's responsibility to ensure that a compatible electromagnetic

environment for the equipment can be maintained in order that the device
will perform as intended.

B.12. Sound
Maximal sound: 65 dBA

NOTE
 Be sure to use and store the analyzer in the specified environment.

B.13. Operating Environment

Optimal operating temperature: 10 ℃～30 ℃

Optimal operating humidity: 20 %～85 %

Atmospheric pressure: 70 kPa～106 kPa

B.14. Storage Environment

Ambient temperature: -10 ℃～40 ℃

Relative humidity: 10 %～90 %

Atmospheric pressure: 50 kPa～106 kPa

B-6
 Specifications

B.15. Running Environment

Ambient temperature: 10 ℃～40 ℃

Relative humidity: 10 %～90 %

Atmospheric pressure: 70 kPa～106 kPa

B.16. Dimensions and Weight

Height

Depth
Width

BC-5130 Analyzer

Width(mm) ≤ 325
Dimensions Height (mm)≤ 435 (with foot)
Depth (mm) ≤ 410
Weight ≤25Kg

B.17. Contraindications
None

B.18. Safety Classification

Level of transient overvoltage: Category II.
Rated pollution degree: 2.

B-7
P/N: 046-010333-00(1.0)