You are on page 1of 228

BC-5300 / BC-5100

Auto Hematology Analyzer

Service Manual
© 2014 - 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2019-08.

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.

Service Contact
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Company Address: Mindray Building, Keji 12th Road South, High-tech Industrial Park,
Nanshan, Shenzhen, 518057, P. R. China

Website: www.mindray.com
E-mail Address: service@mindray.com
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
1 Using This Manual....................................................................................................... 1-1

1.1 Scope ......................................................................................................................... 1-1


1.2 Conventions Used in This Manual ............................................................................. 1-1
1.3 Symbols ...................................................................................................................... 1-2

2 Product Specification ................................................................................................... 2-1

2.1 Equipment Name ....................................................................................................... 2-1


2.2 Intended Use .............................................................................................................. 2-1
2.3 Product overview ........................................................................................................ 2-1
2.4 Specified reagents and volume .................................................................................. 2-2
2.5 Minimum Sample Volume .......................................................................................... 2-2
2.6 Throughput ................................................................................................................. 2-2
2.7 Measurement Mode ................................................................................................... 2-2
2.8 Sample Types............................................................................................................. 2-2
2.9 Sampling mode .......................................................................................................... 2-3
2.10 Operation mode ......................................................................................................... 2-3
2.11 General performance requirements of the system ..................................................... 2-3
2.12 Parameter................................................................................................................... 2-4
2.13 Performance requirements ......................................................................................... 2-8
2.13.1. Requirements of background ..................................................................... 2-8
2.13.2. Requirements of Carryover ........................................................................ 2-8
2.13.3. Reproducibility requirements ...................................................................... 2-9
2.13.4. Linearity requirements .............................................................................. 2-10
2.13.5. Display range of the main parameters ..................................................... 2-11
2.13.6. Correlation requirements of the compare device ..................................... 2-12
2.13.7. Correlation and accuracy requirements of the WBC differential parameters
.................................................................................................................. 2-13
2.13.8. Accuracy requirements............................................................................. 2-13
2.13.9. Identification capability of the abnormal samples .................................... 2-14

3 Software System ......................................................................................................... 3-1

3.1 Overview .................................................................................................................... 3-1


3.2 Password Function ..................................................................................................... 3-1
3.3 Analyzer Software Upgrade ....................................................................................... 3-1
3.4 Software Installation and Upgrade ............................................................................. 3-4
3.4.1. PC Configuration ........................................................................................ 3-4
3.4.2. Hard disk partition ...................................................................................... 3-4
3.4.3. IPU installation procedure .......................................................................... 3-4
3.4.4. IPU upgrade ............................................................................................... 3-8
3.4.5. IPU repair ................................................................................................... 3-8
3.5 Connection Setup of the IPU and Analyzer ................................................................ 3-9
3.5.1 Analyzer Network Setup ............................................................................. 3-9

1
Table of Contents

3.6 LIS Setup and Connection ....................................................................................... 3-10


3.6.1 LIS communication setup ......................................................................... 3-10
3.6.2 Unidirectional LIS communication ............................................................ 3-13
3.6.3 Error indication ......................................................................................... 3-15
3.6.4 Bidirectional LIS communication .............................................................. 3-16
3.6.5 Frequently asked questions and the answers .......................................... 3-17

4 Main Parameters Description ...................................................................................... 4-1

4.1. Parameter source ....................................................................................................... 4-1


4.2. WBC Measurement .................................................................................................... 4-3
4.2.1. Flow Cytometry by Laser ........................................................................... 4-3
4.2.2. Electrical Impedance Method ..................................................................... 4-4
4.2.3. WBC Parameters ....................................................................................... 4-5
4.3. HGB Measurement .................................................................................................... 4-5
4.3.1. Colorimetric Method ................................................................................... 4-5
4.3.2. HGB ............................................................................................................ 4-5
4.4. RBC/PLT Measurement ............................................................................................. 4-5
4.4.1. Electrical Impedance Method ..................................................................... 4-5
4.5. Time counting method ................................................................................................ 4-6
4.5.1. Structure ..................................................................................................... 4-6
4.5.2. Principle ...................................................................................................... 4-6
4.6. Parameter Flag Message Information ........................................................................ 4-6
4.6.1. Flag Message ............................................................................................. 4-6
4.6.2. Shield plan .................................................................................................. 4-9
4.6.3. Sensitivity adjustment mechanism ........................................................... 4-10

5 Error Information of the Analyzer ................................................................................ 5-1

5.1. Error Code .................................................................................................................. 5-1


5.1.1. Pressure Testing ......................................................................................... 5-1
5.1.2. Temperature Module .................................................................................. 5-1
5.1.3. Syringe Module .......................................................................................... 5-4
5.1.4. Sampling assembly module ..................................................................... 5-10
5.1.5. Power voltage ........................................................................................... 5-15
5.1.6. Analog signal board module ..................................................................... 5-15
5.1.7. Reagent test type ..................................................................................... 5-18
5.1.8. Flow cell clog ............................................................................................ 5-21
5.1.9. Background abnormal .............................................................................. 5-22
5.1.10. HGB abnormal.......................................................................................... 5-23
5.1.11. Clog .......................................................................................................... 5-23

6 Fluidic System ............................................................................................................. 6-1

6.1. Analysis Flow ............................................................................................................. 6-1


6.1.1. WBC&HGB channel ................................................................................... 6-2
6.1.2. DIFF & optical channel ............................................................................... 6-3
6.1.3. RBC/PLT channel ....................................................................................... 6-3

2
Table of Contents

6.2. Sample Volume .......................................................................................................... 6-4


6.3. Temperature Control of the Fluidic System ................................................................ 6-4
6.4. Reagent Volume ......................................................................................................... 6-5
6.5. Introduction of Fluidic Components ............................................................................ 6-5
6.5.1. Mindray valves ........................................................................................... 6-5
6.5.2. Two-way pressureproof Mindray valve....................................................... 6-6
6.5.3. LVM fluidic valve ......................................................................................... 6-7
6.5.4. Pinch valve ................................................................................................. 6-7
6.5.5. Liquid filter .................................................................................................. 6-7
6.5.6. Syringes ..................................................................................................... 6-8
6.5.7. Pressure pump ........................................................................................... 6-9
6.5.8. Vacuum pump ............................................................................................ 6-9
6.5.9. Sample probe ........................................................................................... 6-10
6.5.10. Probe wipe ............................................................................................... 6-10
6.5.11. Pressure relief valve ................................................................................. 6-11
6.5.12. Baths ........................................................................................................ 6-12
6.6. Introduction of Fluidic Structure ............................................................................... 6-13
6.6.1. Sample aspiration and dispensing channel ............................................. 6-13
6.6.2. WBC&HGB channel ................................................................................. 6-14
6.6.3. WBC analysis ........................................................................................... 6-15
6.6.4. HGB analysis ............................................................................................ 6-15
6.6.5. DIFF & optical channel ............................................................................. 6-15
6.6.6. RBC/PLT channel ..................................................................................... 6-16
6.7. Introduction of Sequences ....................................................................................... 6-17
6.7.1. Analysis sequences of open vial whole blood CBC+DIFF mode ............. 6-17
6.7.2. Analysis sequences of open vial predilute CBC+DIFF mode .................. 6-52
6.7.3. Analysis sequences of the CBC mode ..................................................... 6-52
6.8. Function of Fluidic Valves ........................................................................................ 6-52

7 Optical System ............................................................................................................ 7-1

7.1. Overview of Optical System Principle ........................................................................ 7-1


7.2. Optical Path and Workflow of the Optical System ..................................................... 7-1
7.3. Components of the Optical System............................................................................ 7-2
7.4. Optical System Status Determination ........................................................................ 7-3
7.5. Maintenance and Replacement of the Optical System .............................................. 7-5
7.5.1. Maintaining the Optical System .................................................................. 7-5
7.5.2. Replacing the Optical System .................................................................... 7-9
7.6. Optical System Gain Calibration .............................................................................. 7-10

8 Hardware System ........................................................................................................ 8-1

8.1. Overview .................................................................................................................... 8-1


8.2. Diagram of Hardware System .................................................................................... 8-1
8.3. Analog Board.............................................................................................................. 8-2
8.3.1. Overview .................................................................................................... 8-2
8.3.2. Function ...................................................................................................... 8-2

3
Table of Contents

8.3.3. Structure ..................................................................................................... 8-3


8.3.4. Interfaces .................................................................................................... 8-4
8.3.5. Indicators and test points ........................................................................... 8-6
8.3.6. Troubleshooting .......................................................................................... 8-7
8.4. Digital Control Board (including CPU module) ......................................................... 8-10
8.4.1. Overview .................................................................................................. 8-10
8.4.2. Function .................................................................................................... 8-10
8.4.3. Structure ................................................................................................... 8-11
8.4.4. Interfaces .................................................................................................. 8-11
8.4.5. Indicators and test points ......................................................................... 8-12
8.4.6. Troubleshooting ........................................................................................ 8-12
8.5. Drive Board .............................................................................................................. 8-13
8.5.1. Overview .................................................................................................. 8-13
8.5.2. Function .................................................................................................... 8-14
8.5.3. Structure ................................................................................................... 8-15
8.5.4. Interfaces .................................................................................................. 8-16
8.5.5. Indicators and test points ......................................................................... 8-17
8.5.6. Troubleshooting ........................................................................................ 8-19
8.6. Laser Control Board ................................................................................................. 8-20
8.6.1. Overview .................................................................................................. 8-20
8.6.2. Function .................................................................................................... 8-20
8.6.3. Structure ................................................................................................... 8-20
8.6.4. Interfaces .................................................................................................. 8-21
8.6.5. Indicators and test points ......................................................................... 8-22
8.6.6. Troubleshooting ........................................................................................ 8-23
8.7. Preamplification Board ............................................................................................. 8-25
8.7.1. Overview .................................................................................................. 8-25
8.7.2. Function .................................................................................................... 8-25
8.7.3. Structure ................................................................................................... 8-25
8.7.4. Interfaces .................................................................................................. 8-26
8.7.5. Indicators and test points ......................................................................... 8-27
8.7.6. Troubleshooting ........................................................................................ 8-27
8.8. Power Board............................................................................................................. 8-29
8.8.1. Overview .................................................................................................. 8-29
8.8.2. Function .................................................................................................... 8-29
8.8.3. Structure ................................................................................................... 8-31
8.8.4. Interfaces .................................................................................................. 8-32
8.8.5. Indicators and test points ......................................................................... 8-34
8.8.6. Troubleshooting ........................................................................................ 8-36
8.9. Fluid Detection Board ............................................................................................... 8-37
8.9.1. Overview .................................................................................................. 8-37
8.9.2. Function .................................................................................................... 8-37
8.9.3. Structure ................................................................................................... 8-37
8.9.4. Interfaces .................................................................................................. 8-38

4
Table of Contents

8.9.5. Indicators and test points ......................................................................... 8-38


8.9.6. Troubleshooting ........................................................................................ 8-39
8.10. Indicator Board ......................................................................................................... 8-39
8.10.1. Overview .................................................................................................. 8-39
8.10.2. Function .................................................................................................... 8-39
8.10.3. Structure ................................................................................................... 8-40
8.10.4. Interfaces .................................................................................................. 8-40
8.10.5. Indicators and test points ......................................................................... 8-41
8.10.6. Troubleshooting ........................................................................................ 8-41
8.11. Mini Network Board .................................................................................................. 8-41
8.11.1. Overview .................................................................................................. 8-41
8.11.2. Function .................................................................................................... 8-41
8.11.3. Structure ................................................................................................... 8-42
8.11.4. Interfaces .................................................................................................. 8-42
8.11.5. Indicators and test points ......................................................................... 8-43
8.11.6. Troubleshooting ........................................................................................ 8-43
8.12. List of Prefixes of Board Sockets ............................................................................. 8-44
8.13. Connections of Wires and Board ............................................................................. 8-45
8.14. Motors, Photocouplers and Micro-switches ............................................................. 8-49
8.15. Analyzer Status Indicated by the Indicators ............................................................. 8-50

9 Mechanical System ..................................................................................................... 9-1

9.1. Analyzer Structure ...................................................................................................... 9-1


9.2. Appearance ................................................................................................................ 9-1
9.3. Layout Introduction ..................................................................................................... 9-3
9.4. Sampling Assembly .................................................................................................... 9-4
9.4.1. Structure Introduction ................................................................................. 9-4
9.4.2. Maintaining the Assembly .......................................................................... 9-7
9.4.3. Replacing the X-Direction Start Position Sensors ...................................... 9-8
9.4.4. Replacing X-Direction Detection Sensor .................................................... 9-9
9.4.5. Replacing Y-Direction Sensor .................................................................... 9-9
9.4.6. Replacing X-Direction Motor .................................................................... 9-10
9.4.7. Replacing Y-Direction Motor ..................................................................... 9-12
9.5. Replace the Syringe Assembly ................................................................................ 9-13
9.5.1. Structure Introduction ............................................................................... 9-13
9.5.2. Relevant Troubleshooting Measures........................................................ 9-16
9.6. Debug Screen Introduction ...................................................................................... 9-20
9.7. Adjusting the Position of the Sample Probe ............................................................. 9-21
9.7.1. Sample Probe Up Position Adjustment .................................................... 9-21
9.7.2. DIFF Bath Up Position Adjustment........................................................... 9-22
9.8. HGB Assembly Replacement ................................................................................... 9-22
9.8.1. Maintenance Protocol .............................................................................. 9-23

5
1 Using This Manual

 Be sure to operate and service the analyzer strictly as instructed in this


manual and the operator's manuals.

1.1 Scope
To use this manual effectively, you need the following capabilities:

 Comprehensive knowledge of circuit and fluidics;

 Comprehensive knowledge of reagents;

 Comprehensive knowledge of controls;

 Comprehensive knowledge of troubleshooting;

 Mastering the way to operate this analyzer;

 Mastering the way to operate this analyzer;

 Using a digital voltmeter (DVM) and an oscilloscope;

 Reading pneumatic/hydraulic schematics and understand related terminology.

Introduction
This manual comprises 13 chapters and 1 appendix. Refer to the table below to find the
information you need.

1.2 Conventions Used in This Manual


When you read … It means …

to press the desired item lightly with your finger; or to


Click
left-CLICK it with the mouse.
to CLICK the desired edit box and use the external keyboard

ENTER or the pop-up keyboard to enter the desired characters or

digits; or to scan the number by using the bar-code scanner.

to move the cursor to the character or digit that you want to


DELETE
delete by clicking the left button of the mouse or using

1-1
Using This Manual

When you read … It means …

[←][→][Home][End], and then delete the character after the

cursor by pressing [Del], or delete the character before the

cursor by pressing [BackSpace] ([←] on the upper right part of

the soft keyboard).

to CLICK the arrow buttons at the ends of the scroll bar; or to


CLICK and hold the mouse button down while dragging the
DRAG SCROLL
scroll bar until the desired information is displayed; or to touch
BAR
the scroll bar and rest your finger there until the desired
information is displayed.

to CLICK the down arrow button of the desired box to display

SELECT from ×× the pull-down list, (and DRAG SCROLL BAR) to browse and

pull-down list then CLICK the desired item; or to press the keys

(for pull-down list) ([↑][↓][PageUp][PageDown]) to browse the current list and

press [ENTER] to select the desired item.

1.3 Symbols

You will find the following symbols in this manual.

When you see… Then…

read the statement below the symbol. The statement is

alerting you to an operating hazard that can cause

personnel injury.

read the statement below the symbol. The statement is

alerting you to a possibility of analyzer damage or unreliable

analysis results.

read the statement below the symbol. The statement is

alerting you to information that requires your attention.

read the statement below the symbol. The statement is

alerting you to a potentially biohazardous condition.

1-2
Using This Manual

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

When you see… It means…

Note: suggesting the users consult to


accompanying documents to get important
safety information.

BIOLOGICAL RISK

CAUTION, RISK OF ELECTRIC SHOCK

WARNING, LASER BEAM

CAUTION, HOT SURFACE

PROTECTIVE EARTH (GROUND)

EARTH (GROUND)

ALTERNATING CURRENT

FOR IN VITRO DIAGNOSTIC USE

TYPE B DEVICE

BATCH CODE

USE BY (YYYY-MM-DD)

SERIAL NUMBER

1-3
Using This Manual

When you see… It means…

DATE OF MANUFACTURE

MANUFACTURER

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

Be sure to observe the following precautions for the safety of patients and operators when
you are servicing the analyzer.

 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 harm to human health.

 Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g.


ethanol) around the analyzer. Otherwise, the risk of explosion may exist.

 When servicing the analyzer, be sure to turn off the power. Servicing the
analyzer when it is on may bring risk of electric shock or damage to electronic
components.

 Connect the analyzer to a socket having sole fuse and protective switch. Do
not use the same fuse and protective switch with other equipment (e.g. life
supporting equipment). Otherwise, the equipment failure, over current or
impulse current that occurs at the startup moment may lead to tripping.

 To prevent personal injury during maintenance, keep your clothes, hairs and
hands from the moving parts, such as sample probe, clipper and piercer.

 Possible mechanical movement of the warned position may lead to personal


injury during the normal operation, removal and maintenance.

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


to government regulations.

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

1-4
Using This Manual

 If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

 Improper maintenance may damage the analyzer. Maintain the analyzer strictly
as instructed by the service manual and inspect the analyzer carefully after the
maintenance.

 For problems not mentioned in the service manual, contact Mindray customer
service department for maintenance advice.

 To prevent personal injury or damage to equipment components, remove


metal jewelry before maintaining or servicing electronic components of the
equipment.

 Electrostatic discharge may damage electronic components. If there is a


possibility of ESD damage with a procedure, then do that procedure at an ESD
workstation, or wear an antistatic wrist strap.

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

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


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

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

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

1-5
2 Product Specification

2.1 Equipment Name


Name: Auto Hematology Analyzer
Models: BC-5300, BC-5100

2.2 Intended Use


The BC-5300 and BC-5100 are a quantitative, automated hematology analyzer and 5-part
differential counter used in clinical laboratories.
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.

 Scope: for in-vitro diagnostic and scientific research and application;

 Operation environment: well-managed clinical laboratory, not used as portable device;

 Operators: This equipment must be operated by skilled/trained clinical professionals.

2.3 Product overview


BC-5300 and BC-5100 are the open-vial model of the low-end hematology analyzer. As
the widespread model, it provide the functions of WBC, RBC and PLT measurements
and WBC 5 differential with 27 parameters which are divided into 3 types (WBC, RBC
and PLT), there are 4 RUO parameters for the WBC parameters. The 27 parameters
are directly measured parameters and parameters calculated indirectly. WBC diff is
realized by Flow Cytometry by Laser (which is dyed by chemical reagents and laser
scattered method) , Electrical Impedance Method, the WBC is gained by Electrical
Impedance Method; RBC, HCT and PLT count are gained by Electrical, HGB is gained
by Colorimetric Method, and other parameters are gained by calculation.
BC-5300 and BC-5100 use external PC computer, only the aspirate key is set on the
device for interaction between people and device, while other operation required to be
performed by the keyboard. The device has basic measurement and analysis function
and can be connected to the hospital test department by the PC, printer and barcode
scanner interface are also offered.
The whole system is formed by BC-5300, BC-5100 and specified reagents, reagents,
controls and calibrators.

2-1
Product Specification

2.4 Specified reagents and volume


It is recommended to use reagents specified by Mindary, namely the 4 test reagents, 2
maintenance reagents, controls and calibrators. See table 2 for detailed requirements.

Table 1 Specified reagents, controls, calibrators and volume

Volume used for single


Components sample
CBC+DIFF CBC
M-53diluent M-53D DILUENT ≤ 45mL ≤ 32mL
M-53LEO(I) LYSE 0
M-53 lyse M-53LEO(II) LYSE ≤ 2.5mL 0
M-53LH LYSE ≤ 1.0mL
Probe cleanser M-53P PROBE CLEANSER /
RD(BC-5D)
Controls /
Mindray(B55)
RD(SC-CAL PLUS)
Calibrators /
Mindray(S50)

Note: the single diluent consumable under the predilute mode includes the diluent volume for
dispensing the diluent.

2.5 Minimum Sample Volume


The two measurements under whole blood mode require no more than 20ul and the Minimum
Sample Volume is 0.5m, Ф12X75 (do not considering the size of the cap) evacuated

blood collection tube;

The two measurements under predilute blood mode require no more than 20ul.

2.6 Throughput
whole blood mode: no less than 60 samples/hour.
predilute blood mode: no less than 50 samples/hour.

2.7 Measurement Mode


Measurement Mode: CBC,CBC+DIFF.

2.8 Sample Types


Two sample types: whole blood and predilute blood.

2-2
Product Specification

Two measurement types can be used under two sample types.

2.9 Sampling mode


Open vial (when the probe meets the tube bottom, it can still aspirate).

2.10 Operation mode


Operation are performed by using the device key which include the switch, aspiration key and
external keyboard.
The run sequence and rules of the connection between analyzer and external PC.
The following two operation can be performed without considering the sequence, the
analyzer and PC are not required to be preconnected, and the analyzer and PC can perform
the following operations independently:
The startup and shutdown of the analyzer;
Start up the PC and software;
Only in the following condition the analyzer is powered on (Startup refers power on,
initialization and normal count status): power on the analyzer, startup the software, input
correct user name and password successfully and the software and analyzer can
communicate normally.

2.11 General performance requirements of the system

Table 2 General performance requirements of the system

Item Design requirements


Startup time(from power on to no more than 20 minutes
count status) requirements
Power off time requirements of no more than 15 minutes
the system

2-3
Product Specification

2.12 Parameter
1. Parameter classification
Measure the WBC, RBC, PLT and HGB of the blood and output 27 Parameters, 3 histogram
and 1scattergram, two measurement types CBC and CBC+DIF are offered as follows:

Table 3 Parameter description

Clone Name Abbreviation CBC CBC + DIFF


White Blood Cell count WBC * *
Basophils number Bas# / *
Basophils percentage Bas% / *
Neutrophils number Neu# / *
Leukon 15 parameters

Neutrophils percentage Neu% / *


Eosinophils number Eos# / *
Eosinophils percentage Eos% / *
Lymphocytes number Lym# / *
Lymphocytes Lym% / *
percentage

, Monocytes number Mon# / *
include 4 RUO parameters

Monocytes percentage Mon% / *


Abnormal Lymphocytes ALY# / *
number
Abnormal Lymphocytes ALY% / *
percentage
Large Immature Cells LIC# / *
number
Large Immature Cells LIC% / *
percentage

Red Blood Cell count RBC * *


Hemoglobin HGB * *
Concentration
RBC-related 8 parameters

Mean Corpuscular MCV * *


Volume
Mean Corpuscular MCH * *
( Hemoglobin
Mean Corpuscular MCHC * *
Hemoglobin
Concentration
Red Blood Cell RDW-CV * *

Distribution Width -
Coefficient of Variation

2-4
Product Specification

Clone Name Abbreviation CBC CBC + DIFF


Red Blood Cell RDW-SD * *
Distribution Width -
Standard Deviation
Hematocrit HCT * *
Platelet count PLT * *
PLT-Related(4

Mean Platelet Volume MPV * *


parameters)

Platelet Distribution PDW * *


Width
Plateletcrit PCT * *

“*” means that parameters are tested under the mode; “/” means that parameters are not
offered under the mode.

Table 4 Histogram description

Name Abbreviation CBC CBC + DIFF


White Blood Cell/ Basophils WBC/BASO / *
Histogram Histogram
White Blood Cell Histogram WBC Histogram * /
Red Blood Cell Histogram RBC Histogram * *
Platelet Histogram PLT Histogram * *

CBC mode:
corresponding histograms include WBC Histogram, RBC Histogram and PLT Histogram;

CBC+DIFF mode:

corresponding histograms include WBC/BASO Histogram, RBC Histogram and PLT


Histogram.

Table 5 Scattergram description

Name Abbreviation CBC CBC + DIFF


Differential Scattergram Diff Scattergram / *

2-5
Product Specification

2. Parameter unit and format

Table 6 Parameter unit and format

Parameter Format Unit Parameter Format Unit

WBC
Lym%
Lym#
Mon%
Mon# ***.** 109/L
Bas%
Bas# ***.** 103/uL **.* %
Eos%
Eos# ****.* 102/uL .***
Neu% None
Neu# ***.** /nL
ALY%
ALY#
LIC%
LIC#
**.** 1012/L **** 109/L
**.** 106/uL **** 103/uL
RBC PLT
**** 104/uL ***.* 104/uL
**.** /pL **** /nL
*** g/L **** g/L
HGB **.* g/dL MCHC ***.* g/dL
**.* mmol/L ***.* mmol/L
***.* pg
***.* fL
MCV MCH **.** fmol
***.* um3
**** amol
**.* % ***.* fL
RDW-CV RDW-SD
.*** None ***.* um3
**.* %
**.* fL
HCT .*** L/L MPV
**.* um3
.*** None

None ( 10
.*** %
PDW **.* PCT
*.** mL/L
GSD)

Note: Fast setup function of the units in different country mentioned in table 8 is provided;
users can set them by passwords. Customization functions are also offered. When there
are many units to be selected, user can customize all the units by the password. The
setup of some parameters unit are correlated.

2-6
Product Specification

Table 7 Units in different country

International SI America Canada


Parameter Format Unit Format Unit Format Unit
WBC ***.** × 109/L ***.** × 103/µ L ***.** × 109/L
RBC **.** × 1012/L **.** × 106/µ L **.** × 1012/L
HGB *** g/L **.* g/dL *** g/L
HCT .*** **.* % .*** L/L
MCV ***.* fL ***.* fL ***.* fL
MCH ***.* pg ***.* pg ***.* pg
MCHC **** g/L ***.* g/dL **** g/L
PLT **** × 109/L **** × 103/µ L **** × 109/L
Lym% .*** **.* % .***
Lym# ***.** × 109/L ***.** × 103/µ L ***.** × 109/L
RDW-SD ***.* fL ***.* fL ***.* fL
RDW-CV .*** **.* % .***
MPV **.* fL **.* fL **.* fL
None None None
**.* **.* **.*
PDW (10GSD) (10GSD) (10GSD)
PCT *.** mL/L . *** % . *** %

Holland England Domestic


Parameter Format Unit Format Unit Format Unit
WBC ***.** × 109/L ***.** × 109/L ***.** × 109/L
RBC **.** × 1012/L **.** × 1012/L **.** × 1012/L
HGB **.* mmol/L **.* g/dL *** g/L
HCT .*** L/L .*** **.* %
MCV ***.* fL ***.* fL ***.* fL
MCH **** amol ***.* pg ***.* pg
MCHC ***.* mmol/L ***.* g/dL **** g/L
PLT **** × 109/L **** × 109/L **** × 109/L
Lym% .*** **.* % **.* %
Lym# ***.** × 109/L ***.** × 109/L ***.** × 109/L
RDW-SD ***.* fL ***.* fL ***.* fL
RDW-CV .*** **.* % **.* %
MPV **.* fL **.* fL **.* fL
None None None
PDW **.* **.* **.*
(10GSD) (10GSD) (10GSD)
PCT *.** mL/L *.** mL/L . *** %

2-7
Product Specification

2.13 Performance requirements


2.13.1. Requirements of background

Table 8 Background Requirements

Parameter Background Requirements

WBC ≤ 0.3  109 / L

RBC ≤ 0.03 1012/ L

HGB ≤1g/L

HCT ≤ 0.5 %

PLT ≤ 10  109 / L
The background requirements are applicable to whole blood and predilute blood.
Background verification: Run the diluent as samples for 3 times, take the maximum value as
the background result.

2.13.2. Requirements of Carryover


Carryover means the carryover extent of the low concentrated sample from the high
concentrated sample.
Verification method:
Domestic: take high value samples within the range of table 12 (high value control centrifuged
or specified high value linear control), test 3 times consecutively, the value are i1,i2 and i3; and
then take low value samples within the range of table 12(the low control is diluent for 10

times),test 3 times consecutively, the value are j1,j2,j3, calculate the carryover with the

following formula, it shall meet the requirements of table 11.


International: take high value samples within the range of table 12,mix them well and test 3

times consecutively, the value are i1,i2,i3; take diluent as low value sample, test 3 times

consecutively, the value are j1,j2,j3, calculate the carryover with the following formula, it shall

meet the requirements of table 11.

2-8
Product Specification

Table 9 Carryover

Parameter Carryover

WBC ≤0.5%

RBC ≤0.5%

HGB ≤0.6%

HCT ≤0.5%

PLT ≤1.0%

Table 10 concentration range of test sample of the carryover

Parameter high value range low value range


WBC > 15.00×109/L < 3.00×109/L
RBC > 6.00×1012/L < 2.00×1012/L
HGB > 200 g/L < 40 g/L
HCT >54.0% <18.0%
PLT > 300×109/L < 100×109/L

2.13.3. Reproducibility requirements


Verification method:

Domestic: Take a sample within the following range, test for 10 times consecutively, and

calculate the (CV,%) or (d) with the formula.

International: Take a sample within the following range, test for 11 times consecutively, take

to results of 2-11 results to calculate the (CV,%) or (d) with the formula.

in the formula:

s ---- standard deviation of the sample test;


x ---- mean of the sample test;

xi
---- Test value of the sample;

d ---- Absolute deviation of the sample test value.

2-9
Product Specification

Table 11 Reproducibility requirements

Whole blood (CV /


Parameter Test range Predilute (CV)
Absolute deviation d*)

WBC 4.00×109/L~15.00 109 / L ≤2.0% ≤4.0%

50.0%~60.0% ±4.0(d) ±8.0(d)


Neu%

25.0%~35.0% ±3.0(d) ±6.0(d)


Lym%

5.0%~10.0% ±2.0(d) ±4.0(d)


Mon%

2.0%~5.0% ±1.5(d) ±2.5(d)


Eos%

0.5%~1.5% ±0.8(d) ±1.2(d)


Bas%

RBC 3.50  1012 / L ~ 6.00  1012 / L ≤1.5% ≤3.0%


HGB 110 g/L ~ 180 g/L ≤1.5% ≤3.0%

70 fL~120 fL ≤1.0% ≤2.0%


MCV

PLT 150  109 / L ~ 500  109 / L ≤4.0% ≤8.0%


MPV / ≤4.0% ≤8.0%

2.13.4. Linearity requirements


Under whole blood and predilute mode, prepare samples of different concentration and
test them in order, calculate the slope and intercept with linearity equation and gain the
theory value, get the deviation between the theory value and test value, it shall meet the
following requirements.

2-10
Product Specification

Table 12 Linearity requirements

Parameter Linearity range Whole Blood Mode* Predilute Mode

WBC
0.00×109/L ~ ±0.30×109/L or ±5% ±0.60×109/L or ±6%

99.99×109/L

RBC
0.00×1012/L ~ ±0.05×1012/L or ±5% ±0.10×1012/L or ±10%

8.00×1012/L

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

PLT
0×109/L~1000×109/L ±10×109/L or ±8% ±20×109/L or ±16%

(RBC≤7.0)

HCT 0%~67% ±2%(HCT) or ±3% ±4%(HCT) or ±6%


(error percentage) (error percentage )

2.13.5. Display range of the main parameters


Table 13 Linearity Requirements

Parameter Linearity range Display range

WBC 0.00~99.99×109/L 0~200.0×109/L

RBC 0.00~8.00×1012/L 0~18.00×1012/L

HGB 0~250g/L 0~300g/L

PLT 0~1000×109/L 0~2000×109/L

HCT 0~67% 0%~80%

2-11
Product Specification

2.13.6. Correlation requirements of the compare device

Correlation requirements to the compare device

Select a high end 5-diff analyzer to perform correlation evaluation. The compare analyzer and
the BC-5300 shall be calibrated before the correlation evaluation and count the regression
equation. In the statistical analysis, pick out the samples of which the accuracy will be
influenced by the principle, such as microcytes, existed nucleated red blood cell and so on. In

the statistical regression equation: Y = aX + b; count the correlation coefficient r.

Table 14 Correlation requirements of the whole blood count

Parameter r
WBC ≥ 0.99
RBC ≥ 0.99
HGB ≥ 0.98
MCV ≥ 0.98
PLT ≥ 0.95

Correlation analysis and regression calculation:

Correlation factor

n is sample quantity

Regression equation: Y=aX+b,meanwhile:

n 2
  ( Xij  X )(Yij  Y )
i 1 j 1
a
n 2 2
  ( Xij  X )
i 1 j 1

b  Y  a X ; n is sample quantity

2-12
Product Specification

2.13.7. Correlation and accuracy requirements of the WBC differential


parameters
Correlation requirements
Select 100 normal samples and 100 abnormal sample to perform correlation test with CLSI
reference method (H20, microscope method), take the mean and analyzer results to perform
correlation analysis.
In the equation of linear regression, pick out the sample whose accuracy is restricted by
the principle. In equation of linear regression: Y = aX + b; calculate the correlation
coefficient r, which shall meet the following requirements. Calibrate the analyzer before
performing the correlation test.

Table 15 correlation requirements of the whole blood differential

correlation coefficient r to the manually


Parameter
differential

Neutrophils (Neu%) ≥0.90

Lymphocytes (Lym%) ≥0.90


monocyte (Mon%) ≥0.75
Eosinophils (Eos%) ≥0.80
Basophils (Bas%) ≥0.50

2.13.8. Accuracy requirements


Select 20 samples tested with manual differentiate correlation at random,using the 99%
trustable range calculation method to gain the trastable range of manual differentiate
range. Compare the mean of results tested by the device with the trustable range,within
the range of ≥99% of the trustable range lower limit or≤99% of the upeer limint are
judged as qualified, those who are out of the range are judeged as unqualified.
1. Calculating standard deviation
pq
Equation: SEp=
n
In the equation, n=200; p= mean obtained with the reference method; q=100-p; when
freedom is 199, the t distribution factor of 99% credibility limit =2.57.
2. Calculating credibility range

The 99% credibility range of a parameter rate: p±2.57×SEp.


3. Requirement

The Lym%, Neu%, Mon%, Eos% and Bas% results tested by the analyzer must be within the
99% credibility range of the results tested by the reference method.

2-13
Product Specification

2.13.9. Identification capability of the abnormal samples


Microscopic Exam. Positive: the WBC differentiate are out of the normal reference range,
there are special particles, NRBCs, abnormal morphology and abnormal growth and so
on.
Analyzer positive: the differentiate results are out of the reference range, there are
histogram flag.

Table 16 Definition of the abnormal samples

Analyzer result
Microscopic exam result positive negative
positive TP (True Positive) FN (false negative)
Negative FP (false positive) TN (True Negative)
false positive flagging rate = FP /(TN + FP)*100%
false negative flagging rate = FN /(FN + TP)*100%
Capability requirements to identify the abnormal samples: analyze the differentiate results of

the analyzer and microscope exam. results,, false negative < 15%; false positive < 20%。

The verification method will be described in details in the clinical verification plan.

2-14
3 Software System

3.1 Overview
The software system is consisted of the analyzer software and the PC operation software -
IPU. The analyzer software runs in the analyzer CF card, the operation software IPU runs in
the Windows 7 Home Basic*32, Windows 7 Ultimate*32, Windows 7 Ultimate*64, Windows
8 Professional*32, Windows 8 Professional*64, Windows 8 Standard*32 and Windows 8
Standard*64 systems. The analyzer software analyzes sequences, collects and reads data;
while the IPU saves, displays and prints results, displays analysis and QC data, and realizes
data management, parameter setup and communication.

3.2 Password Function


There are 3 levels of passwords, general user, administrator and service engineer. The
administrator can access all functions of the general user, and the service engineer can
access all functions of the administrator. User name and password of the IPU:

Level User name Password


Service engineer service Se s700

3.3 Analyzer Software Upgrade


The installation & upgrade package shall be decompressed first. The package contains IPU
installation package, analyzer upgrade package and installation & upgrade instructions.
1.Upgrade package
Decompress the upgrade package, you will have:

Figure 3-1 Analyzer software upgrade package

The installation packages of open vial and closed tube models are consolidated into one.

2.Upgrade procedure
Start the upgrade tool:

3-1
Software System

Figure 3-2 Analyzer upgrade software menu

Select "Analyzer Upgrade"

Figure 3-3 Analyzer upgrade confirmation screen

Logon: only user of service access level or above may perform analyzer upgrade.

3-2
Software System

Figure 3-4 Analyzer upgrade software logon screen

Select upgrade file: the upgrade directory

Figure 3-5 Select upgrade file

After uploading, the upgrade process starts. If the kernel is upgraded, the above steps shall
be repeated to complete upgrade.
Kernel upgrade done.
Repeat the above steps to upgrade again.
When the process completes, restart the analyzer to complete upgrade.

Figure 3-6 Upgrade done

 Upgrade duration

3-3
Software System

Complete upgrade of the analyzer software requires 5~8 minutes.

Note:

1) Do not disconnect power of the analyzer during the upgrade process, even if the process

bar stays still for a while, or the upgrade may fail or the analyzer cannot be started.

2) Close the IPU before upgrade. The IPU shall be closed during analyzer upgrade process.
3) Power off the analyzer when prompt message instructs you so. Start up the analyzer 2
minutes later after the shutdown to continue with the upgrade.
4) If the upgrade fails, repeat the upgrade procedure again.

5) Ensure the completeness of the upgrade package, do not modify any file in the

package.

6) Keep anti-virus software and fire wall closed throughout the upgrade process.

3.Handling upgrade failure


Upgrade failed and insufficient disk space is reported, check the disk space.
If the upgrade fails, repeat the upgrade procedure again.
Ensure the completeness of the upgrade package, do not modify any file in the package.

3.4 Software Installation and Upgrade


3.4.1. PC Configuration
Hardware configuration Software configuration
CPU: E3300 Operation system:
Memory: 2GB Windows 7 and the versions above are
Hard disk: 320GB recommended
CD-ROM: DVD-RW
Network card: dual network card (1 integrated Database: SQLite

card, and 1 independent card)

3.4.2. Hard disk partition


Recommended hard disk partition:
Disk C: 40G system disk for installation of operation system and IPU
Disk D: 200G data disk store IPU data and backup data
Disk E: 80G file disk store other files

3.4.3. IPU installation procedure


1. Open the installation disk, right click the file setup.exe, and select "Run as administrator" to
start installation.

3-4
Software System

Figure 3-7 Run installation program

2. The "User Account Control" dialog box displays, select "Yes" to install the application.
3. The installation program checks system environment, such as operation system version
and database, and then the following dialog box displays.

Figure 3-8 Database installation

3-5
Software System

4. If there are modules missing for installation of the IPU, install the modules, and restart
the PC when the prompt message instructs so.
5. After all necessary modules are installed, the language selection screen displays,
select the desired language of the IPU here.

Figure 3-9 Language selection dialog box

6. Click OK to enter the model selection dialog box, select the desired product model
here (the following figure is given as an example, please select based on the actual
product model).

Figure 3-10 Model selection dialog box

8. Click "Next “to enter the installation path selection dialog box. The installation program
is normally installed in non-system disk. To make sure the "Analyzer IPU Software" can
run properly, the residual space of the installation disk shall be more than 100M.

3-6
Software System

Figure 3-11 Installation path selection dialog box

9. Click "Next" to start the installation process of "Analyzer IPU Software".


10. Click "OK" to conclude the installation process. An shortcut icon will be created on
the desktop and in the system menu.

Figure 3-12 Installation finished

Figure 3-13 Shortcut icon on the desktop

3-7
Software System

Figure 3-14 Shortcut icon in the system menu

3.4.4. IPU upgrade


"Analyzer IPU Software" upgrade refers to installation of higher version software on the
basis of the lower version. During the upgrade process, database installation directory
and installation path selection dialog box will be not displayed. The functions to be
completed are database structure upgrade, configuration file upgrade, print template
upgrade. During the upgrade process, the print template upgrade dialog box will be
displayed.

Figure 3-15 Upgrade the "Analyzer IPU Software"

3.4.5. IPU repair


When the "Analyzer IPU Software" fails to run as normal due to file damage, double click the
installation program, the "Repair and Upgrade" dialog box will display for you to repair or
upgrade the software.

3-8
Software System

Figure 3-16 Modify, repair or delete

This operation only affect program files.

3.5 Connection Setup of the IPU and Analyzer


3.5.1 Analyzer Network Setup
Install the IPU, the default analyzer IP is 10.0.0.7.
To modify analyzer IP, click "Setup - Advanced" to enter the following screen and input the
value of each field.

Figure 3-17 IP address setup

3-9
Software System

Click "Apply". After restart the analyzer, the IP address will be refreshed.

Connection status

Start the IPU and check the connection status icon on the top right; flickering blue
suggests the connection is alright.

Figure 3-18 Connection status icon

3.6 LIS Setup and Connection


3.6.1 LIS communication setup
The communication function supports unidirectional and bidirectional transmission of
analyzer data to LIS (HIS). The communication setup is done on the IPU. Scattergrams
and histograms can be transmitted in both binary and bitmap modes.
Network port communication is supported. Connection to LIS as client end or server is
supported. There are dynamic graphs or progress bars indicating communication
process. To ensure data safety during transmission, exiting from the IPU software is not
allowed. If you try to exit from the IPU, the dialog box "Transmitting, please try again
later...".
The communication setup of the IPU is as follows.

3-10
Software System

Figure 3-19 LIS connection setup screen

NOTE
1. Only support network port communication.
2. If IPU as server is not selected, then the IPU serves as a client end.
3. IP address: valid in the condition of IPU client end network port communication.
When the IPU communicates as client end, fill in the IP address of LIS server; when
the IPU communicates as server, the address is neglected.
4. Port: valid in the condition of IPU network port communication When the IPU
communicates as client end, fill in the LIS server port; when the IPU communicates
as server, and fill in name of the monitoring port of the local PC.
5. IPU as server: valid in the condition of network port communication; select this item,
the IPU will communicate as TCP server, or it will communicate as TCP client end.
6. Protocol type: select protocol and coding type, "HL7+UTF8" is supported by now.

3-11
Software System

7. ACK synchronous communication: this option applies to HL7 protocol in the


condition of network port communication, or this option will be neglected.
8. ACK overtime: valid if ACK synchronous communication applies; it refers to the
longest waiting interval of ACK message after the IPU sends analysis results.
9. Bidirectional LIS/HIS communication: if this option is selected, the analyzer will
search for sample information from LIS during analysis.
10. Auto Transmission: if this option is selected, sample results and L-J QC results with
special sample ID will be auto transmitted to IPU.
11. Histogram/scattergram transmitted as bitmap: if this option is not selected, the
bitmap data of histogram/scattergram transmitted is consistent with the screen
display; if it is selected, the bitmap data of histogram/scattergram transmitted is
consistent with the print output, with white background and the histogram only has
its profile.
12. L-J QC results transmitted in the format of sample results: if this option is selected,
L-J QC results will be transmitted in the format of sample results (for both auto
transmission and manual transmission); if it is not selected, L-J QC results will be
transmitted in the format of QC message.
13. Histogram transmission mode:
a. Not transmit, sample results do not include histogram data
b. Bitmap, sample results include histogram bitmap data
c. Data, sample results include binary raw data of the histogram.
14. Scattergram transmission mode:
a. Not transmit, sample results do not include scattergram data
b. Bitmap, sample results include scattergram bitmap data
c. Data, sample results include binary raw data of the scattergram.
15. Version
a. Default version is 1.0; it supports LIS communication of the former version.
b. If version 1.1 is selected, the transmitted contents will include new flags like WBC
system abnormal, DIFF system abnormal, RBC system abnormal, aspiration
abnormal, system abnormal and RBC clump.

3-12
Software System

3.6.2 Unidirectional LIS communication


Function overview
1. Auto transmission of normal samples
When IPU receives analysis results of normal samples, and auto transmission is on, the
results will be auto transmitted to LIS. If transmission succeeded, the samples will be
marked as transmitted samples in the review and report screen; if failed, prompt
message will be given.
2. Auto transmission of QC samples
a. When IPU receives analysis results of QC samples, and auto transmission is on,
the results will be auto transmitted to LIS. If transmission failed, prompt
message will be given.
b. If "L-J QC results transmitted in the format of sample results" is selected, the L-J
QC results will be encoded as normal sample information; if it is not selected,
the L-J QC results will be encoded QC information.
c. Only L-J QC sample with special sample ID will be auto transmitted.
3. Batch transmission of samples
Batch transmission of normal sample results can be initiated from the review and report
screen. If transmission succeeded, the sample results will be marked as transmitted. If
transmission ACK error occurs, prompt message will be given; if network connection
breaks off, prompt message will be given and the batching transmission will be
terminated.
4. Batch transmission of QC samples
Batch transmission of QC sample results can be initiated from the QC screen. If
transmission ACK error occurs, prompt message will be given; if network connection
breaks off, prompt message will be given and the batching transmission will be
terminated.
5. QC sample transmission parameters
a. The original value and display value of X-R, X Mean QC samples will be
transmitted.
b. For X-B QC, only the display value will be transmitted.
6. Batch transmission of samples in the review screen
Select samples in the review screen and click the Transmit button to transmit the
selected samples.

3-13
Software System

Figure 3-20 Batch transmission of samples in review screen

7. Click the Transmit button at the QC table screen, a dialog box displays, and then
click "Start" to send data. If no data is selected or the date range is illegal, prompt
message will be given.

3-14
Software System

Figure 3-21 Transmission of samples in QC table screen

3.6.3 Error indication


1. IPU as server
a. LIS off indication: no LIS connection, the LIS icon shows connection breaks off.
b. Error message for connection break-off during transmission: Connection breaks
off! The LIS icon shows connection breaks off.
2. IPU as client end
a. Connection establishment failed: LIS connection failed. The LIS icon shows
connection breaks off.
b. Error message for connection break-off during transmission: Connection breaks
off! The LIS icon shows connection breaks off.
c. ACK response failed: transmission is continued, and the message "ACK
response failed!" is given. The message bubble will keep showing. The LIS
icon shows connection is on.

3-15
Software System

3.6.4 Bidirectional LIS communication


Worklist of bidirectional LIS
On the worklist screen of bidirectional LIS, only the sample ID, loading mode, sample mode
and sample position boxes can be edited. Inquiry will be sent to LIS when saving records, a
progress bar will display at the bottom of the screen, and the sample list will be locked. When
legal result are found, the progress bar will disappear, the list will be unlocked and the screen
will be refreshed. If the inquiry times out, fails or the results are illegal, the saving operation
will be canceled.
Operation procedure:
Click the Add worklist button to create a blank worklist. Enter the sample ID, switch the cursor
or click Save directly. The IPU sends inquiry to LIS:
1. If the server fails to get started, the message "Monitoring initiation failed, restart the
IPU or modify the communication port and then try communication operation again."
will be displayed.
2. If the LIS function cannot be used at present, the message "No LIS/HIS connection
available" will be displayed, and saving operation will fail.
3. The communication module completes inquiry:
a. If communication error occurs or communication times out, the message
"Communication times out!" will be displayed.
b. If analysis mode is not obtained or illegal, the message "Invalid analysis mode"
will be displayed. If loading mode or sample mode is obtained, the information
will be displayed on the screen, and valid patient information will be displayed
too.
c. If patient information does not meet the requirement of the IPU data dictionary,
or pass the screen restriction check, the message "Obtained info. invalid" will
be displayed. If loading mode or sample mode is obtained, the information will
be displayed on the screen, analysis mode and valid patient information will be
displayed too.
d. If information obtained is legal, and loading mode or sample mode is obtained,
the information will be displayed on the screen, analysis mode and patient
information will be displayed too.

NOTE
The loading mode or sample mode editing can be done in the process of the inquiry,
they can be modified any time in the saving process.

Report pre-entry of bidirectional LIS


The bidirectional LIS function does not affect report pre-entry. Users can pre-enter
information, but when saving results, the information searched by the bidirectional LIS will be
used.

3-16
Software System

Analysis of bidirectional LIS


1. When bidirectional LIS is on, analysis with sample ID auto increment is not allowed.
2. Bidirectional LIS affects open vial analysis not following the worklist and autoloading
analysis not following the worklist (following built-in barcode instead).

3.6.5 Frequently asked questions and the answers


Q: Why does LIS connection fail?
A: IPU sends inquiry to LIS, the message includes sample ID. LIS shall respond to the inquiry
with results (including mode and patient information) within 10s; if the respond times out,
prompt message will be given, and the saving operation or analysis flow will be terminated.
Q: Why cannot the communication function be used?
A: Invalid or no LIS communication setup; IPU is the server and no LIS connection.
Q: How many kinds of bidirectional LIS inquiry failure are there?
A:
1) "No LIS/HIS connection available": users do not input legal connection settings,
communication cannot be started.
2) If the server fails to get started, the message "Monitoring initiation failed, restart the
IPU or modify the communication port and then try communication operation again."
will be displayed.
3) "Measurement mode invalid": there is no measurement mode in the message
received, or the measurement mode cannot be recognized.
4) "Communication times out": response times out; the response is not consistent with
the IPU data dictionary.
Q: Why does bidirectional LIS inquiry fail?
A: invalid or abnormal data.
Data sent from LIS will be considered invalid in the following conditions:
1) Character codes cannot be recognized.
2) String length exceeds storage limit.
3) Content is not the conventional type. For example: loading mode is not "OV", "AL" or
"CT".
For patient information, if content of a field is invalid, then the field is invalid, other patient
information fields are still valid.
Abnormal data refers to:
1) Communication times out;
2) Invalid data;
3) Missing field;
4) Not conforming to current mode.

3-17
Software System

Abnormal situations Data entry rules of the analyzer

Missing field Default mode will be used if users do not select mode
Invalid data after starting the analyzer or before turning on
Loading and bidirectional LIS. If users do select mode, the
sample mode selected mode will be used. If there are samples
already analyzed, mode of the previous sample will
be used.

Missing field Default mode will be used if users do not select mode

Invalid data after starting the analyzer or before turning on


bidirectional LIS. If users do select mode, the
Analysis mode
selected mode will be used. If there are samples
already analyzed, mode of the previous sample will
be used.

Patient Missing Blank


information Invalid data Blank

3-18
4 Main Parameters Description

4.1. Parameter source


Test the parameters such as WBC, RBC, PLT and HGB of the blood and output 27
parameters, see the following table for details.

Clone Name Abbreviation Parameter source

White Blood WBC Gain the WBC by electric impulse number


Cell count tested by the analyzer
Basophil Bas# Bas# = Bas%*WBC
number
Basophil Bas% Bas% = Baso particle numbers in the BAS
percentage area in the Baso channel *100%/WBC
Neutrophil Neu# Neu# = WBC*Neu%
number
Neutrophil Neu% Neu% = particle numbers in the Neu area in
percentage the DIFF channel*100%/ all particle numbers
Leukon

except the ghost area in the Diff channel


Eosinophil Eos# Eos# = WBC*Eos%

parameters

number
Eosinophil Eos% Eos% = particle numbers of the Eos area in the
percentage DIFF channel *100%/ all particle number
except the ghost area in the DIFF channel


Lymphocyte Lym# Lym# = WBC*Lym%
include 4 RUO parameters

number
Lymphocyte Lym% Lym% = particle numbers of the Lym area in
percentage the DIFF channel *100%/ all particle number
except the ghost area in the DIFF channel
Monocyte Mon# Mon# = WBC*Mon%
number
Monocyte Mon% Mon% = particle numbers of the Mon area in
percentage the DIFF channel *100%/ all particle number
except the ghost area in the DIFF channel
Abnormal ALY# ALY# = WBC*ALY%
Lymphocyte
number
Abnormal ALY% ALY% = particle numbers of the ALY area in
Lymphocyte the DIFF channel *100%/ all particle number
percentage except the ghost area in the DIFF channel

4-1
Main Parameters Description

Clone Name Abbreviation Parameter source


Large LIC# LIC# = WBC*LIC%
Immature Cell
number
Large LIC% LIC% = particle numbers of the LIC area in the
Immature Cell DIFF channel *100%/ all particle number
percentage except the ghost area in the DIFF channel
Red Blood Cell RBC Gain the RBC by electric impulse number
count tested by the analyzer
Hemoglobin HGB HGB=Constant*Ln(background permeate light
Concentration intensity/ sample permeate light intensity)
Mean MCV Gain the MCV by the RBC histogram
Corpuscular
Volume
Mean MCH MCH = HGB/RBC
Corpuscular
Hemoglobin
RBC-related(8 parameters)

Mean MCHC MCHC = HGB*100/HCT


Corpuscular
Hemoglobin
Concentration
Red Blood Cell RDW-CV Gain by the RBC histogram
Distribution
Width -
Coefficient of
Variation
Red Blood Cell RDW-SD Gain by calculating the SD of Corpuscular
Distribution Volume
Width -
Standard
Deviation
Hematocrit HCT HCT = RBC*MCV/10
Platelet PLT Gain the PLT by electric impulse number
PLT-related (4 parameters)

tested by the analyzer


Mean Platelet MPV Calculated by the PLT histogram
Volume
Platelet PDW Gain by the PLT histogram, which is 10GSD of
Distribution the PLT distribution
Width
Plateletcrit PCT PCT = PLT*MPV/10000

4-2
Main Parameters Description

4.2. WBC Measurement


4.2.1. Flow Cytometry by Laser

Figure 4-1 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 2-dimensional distribution
(scattergram). As shown in the following figure , X-axis represents the intracellular density
and Y-axis the blood cell size. Various types of analysis data can then be obtained from the
scattergrams.

4-3
Main Parameters Description

Figure 4-2 DIFF channel scattergram

By analyzing the DIFF channel scattergram, the analyzer presents the Lym%, Mon%, Eos%
and Neu%.

4.2.2. Electrical Impedance Method


WBCs/BASs 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. An electrode 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 signals the number
of particles that passed through the aperture. The amplitude of each pulse is proportional to
the volume of each particle.

Figure 4-3 Electrical Impedance method

4-4
Main Parameters Description

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

4.2.3. WBC Parameters


Based on the analysis of the DIFF channel scattergram and the Lym region, Neu region, Mon
region and Eos region, the analyzer calculates the Lym%, Mon%, Eos% and Neu%. Having
achieved the WBC, the analyzer proceeds to calculate Lym#, Neu#, Mon# and Eos# per the
following equations while Bas# is obtained directly by the Electrical Impedance method and
express them in 109/L.

4.3. HGB Measurement


4.3.1. Colorimetric Method
HGB is determined by the 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 525 nm. An LED is mounted on one side of
the bath and emits a beam of monochromatic light, whose central wavelength is 525nm. 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.

4.3.2. HGB
The HGB is calculated per the following equation and expressed in g/L.

 Blank Phot ocurrent 


HGB(g/L)  Constant  Ln  
 Sample Photocurr ent 

4.4. RBC/PLT Measurement


4.4.1. 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. An electrode 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 signals the number
of particles that passed through the aperture. The amplitude of each pulse is proportional to
the volume of each particle.

4-5
Main Parameters Description

4.5. Time counting method


4.5.1. Structure

1.Cancel the Volumetric Board and the 6 corresponding valves


2.Change the Vacuum chamber from 128mL to 200mL

4.5.2. Principle
Volumetric method of the 53 series: The sample volume of each count (WBC 500uL, RBC

300uL) are measured by tube of fixed volume and initiated by the photocoupler.

Volumetric tube is canceled of the 5300 series, the volume of the impedance channel are
guaranteed by stable count time and stable aperture flow.
Time counting method of the 5300 series: The volume of each count is guaranteed by the
following formula:
Measuring volume = Volumetric time x Aperture flow rate

4.6.Parameter Flag Message Information


4.6.1. Flag Message
There are 32 flag messages, which include suspective flag and confirmative flag. Suspective
flag indicates the flag is suspective while confirmative flag indicates the item is abnormal. See
the following table for the indication and criteria of each flag.

4-6
Main Parameters Description

Channel Flag Message Property Indication Criteria

Calculate and
Suspectable The WBC may be
WBC abnormal compare special
flag incorrect
parameters
Presence of
abnormally
RBC Lyse Suspectable Possibility of RBC distributed dots in
resistance flag lyse resistance WBC sensitive
region of the WBC
scattergram
The distribution of
WBC Suspectable Abnormal distribution
DIFF scattergram
Scattergram Abn. flag of WBC scattergram
is abnormal
The distribution of
WBC histogram Suspectable Abnormal distribution
histogram is
Abn. flag of WBC histogram
abnormal
Presence of
excessive dots in
Suspectable
Left Shift Possibility of left shift left shift sensitive
flag
region of the
scattergram
WBC Possible presence of Presence of
immature excessive dots in
Suspectable granulocytes immature
immature cells
flag granulocyte
sensitive region of
the scattergram
Abnormal
Suspectable possibility of scattergram/there
Abn./Atypical Lym
flag Abn./Atypical Lym are excessive dots
in the Atypical Lym
Confirmative WBC >
leukocytosis WBC high
flag 18.00×10^9/L
Confirmative WBC <
Leukopenia WBC low
flag 2.50×10^9/L
Confirmative Neu# >
Neutrophilia Neu# high
flag 11.00×10^9/L
Confirmative Neu# <
Neutropenia Neu# low
flag 1.00×10^9/L
Confirmative Lym# >
Lymphocytosis Lym# high
flag 4.00×10^9/L
Lymphopenia Confirmative Lym# low Lym# <

4-7
Main Parameters Description

Channel Flag Message Property Indication Criteria

flag 0.80×10^9/L
Confirmative Mon# >
Monocytosis Mon# high
flag 1.50×10^9/L
Confirmative Eos# >
Eosinophilia Eos# high
flag 0.70×10^9/L
Confirmative Baso# >
Basophils high Baso# high
flag 0.20×10^9/L
Hemoglobin abnormal Calculate and
Turbidity/HGB Suspectable
or there is HGB compare special
Interference flag
interference parameters
Calculate and
Suspectable RBC results possibly
RBC compare special
flag inaccurate
Agglutination parameters
Two or more wave Two or more wave
Dimorphic Suspectable
crests in the RBC crests in the RBC
Population flag
histogram histogram
The distribution of
Suspectable Abnormal distribution
RBC Histogram RBC histogram is
flag of RBC histogram
Abn. abnormal
Calculate and
Suspectable Possibility of iron
RBC Iron Deficiency compare special
flag deficiency
parameters
Confirmative RDW-CV> 22 or
Anisocytosis Anisocytosis
flag RDW-SD > 64fL
Microcytosis Confirmative MCV low
MCV < 70fL
flag
Macrocytosis Confirmative MCV high
MCV > 113fL
flag
Confirmative RBC >
erythrocytosis RBC high
flag 6.5×10^12/L
Confirmative
Anemia Anemia HGB < 90g/L
flag
Confirmative
Hypochromia Hypochromia MCHC<290
flag
Abnormal The distribution of
Suspectable Abnormal distribution
distribution of PLT PLT histogram is
flag of PLT histogram
histogram abnormal
Calculate and
PLT Suspectable Possibility of PLT
Platelet clumps compare special
flag clump
parameters
Confirmative PLT high
Thrombocytosis PLT>600×10^9/L
flag

4-8
Main Parameters Description

Channel Flag Message Property Indication Criteria

Confirmative PLT low


Thrombopenia PLT<60×10^9/L
flag

4.6.2. Shield plan


See the following table for the shield relation of each flag.

Channel
Flag message Property Shield relation
name
Shield related parameters
WBC Abn. Suspectable flag of the WBC clone or
prompt “R”
Shield related parameters
RBC Lyse
Suspectable flag of the WBC clone or
resistance
prompt “R”
Shield related parameters
WBC Scattergram
Suspectable flag of the WBC clone or
Abn.
prompt “R”
Shield related parameters
WBC Histogram
Suspectable flag of the WBC clone or
abn.
prompt “R”
related parameters of the
Left Shift Suspectable flag
WBC clone or prompt “R”

related parameters of the


Immature Cell Suspectable flag
WBC WBC clone or prompt “R”

related parameters of the


Abn./Atypical Lym Suspectable flag
WBC clone or prompt “R”
Leucocytosis Confirmative flag /
Leucopenia Confirmative flag /

Neutrophilia Confirmative flag /

Neutropenia Confirmative flag /

Lymphocytosis Confirmative flag /

Lymphopenia Confirmative flag /

Monocytosis Confirmative flag /

Eosinophilia Confirmative flag /

Basophilia Confirmative flag /

4-9
Main Parameters Description

Channel
Flag message Property Shield relation
name
Turbidity/HGB related parameters of the
Suspectable flag
Interference RBC clone or prompt “R”

Hemo related parameters of the


Suspectable flag
Agglutination RBC clone or prompt “R”
Shield related parameters
Dimorphic
Suspectable flag of the RBC clone or
Population
prompt “R”

RBC histogram related parameters of the


Suspectable flag
RBC abn. RBC clone or prompt “R”
Iron Deficiency Suspectable flag /

Anisocytosis Confirmative flag /

Microcytosis Confirmative flag /

Macrocytosis Confirmative flag /

Erythrocytosis Confirmative flag /


Anemia Confirmative flag /
Hypochromia Confirmative flag /

PLT Histogram related parameters of the


Suspectable flag
Abn RBC clone or prompt “R”

related parameters of the


PLT Platelet clumps Suspectable flag
RBC clone or prompt “R”
thrombocytosis Confirmative flag /
Thrombocytopenia Confirmative flag /

4.6.3. Sensitivity adjustment mechanism


Meet the requirements of each hospital by Sensitivity adjustment mechanism flag rate. There
are two types of the Sensitivity adjustment mechanism: QFLA Adjustment mechanism
/Sensitivity coefficient adjustment mechanism. There is no access restriction for the QFLA
Adjustment mechanism, the adjustable range is 0~100. Only access of the customer service
or above can adjust the Sensitivity adjustment mechanism, the adjustable range is 0~10.

Flag Property Venous blood capillary blood

QFLA Adjustment mechanism


Suspectable QFLA Adjustment /Sensitivity coefficient
WBC Abnormal flag mechanism adjustment mechanism
RBC Lyse Suspectable QFLA Adjustment QFLA Adjustment mechanism
resistance flag mechanism / Sensitivity coefficient

4-10
Main Parameters Description

Flag Property Venous blood capillary blood

adjustment mechanism
QFLA Adjustment
mechanism /
Sensitivity
WBC Scattergram Suspectable coefficient QFLA Adjustment mechanism
Abn. flag adjustment / Sensitivity coefficient
mechanism adjustment mechanism
WBC histogram Suspectable QFLA Adjustment
Abn. flag mechanism QFLA Adjustment mechanism
QFLA Adjustment mechanism
Suspectable QFLA Adjustment /Sensitivity coefficient
Left Shift flag mechanism adjustment mechanism
QFLA Adjustment mechanism
Suspectable QFLA Adjustment / Sensitivity coefficient
Immature Cell flag mechanism adjustment mechanism
QFLA Adjustment mechanism
Suspectable QFLA Adjustment Sensitivity coefficient
Abn./Atypical Lym flag mechanism adjustment mechanism
Turbidity/HGB Suspectable QFLA Adjustment
Interference flag mechanism QFLA Adjustment mechanism
Hemo Suspectable QFLA Adjustment
Agglutination flag mechanism QFLA Adjustment mechanism
Dimorphic Suspectable QFLA Adjustment
Population flag mechanism QFLA Adjustment mechanism
RBC histogram Suspectable QFLA Adjustment
abn. flag mechanism QFLA Adjustment mechanism
Suspectable QFLA Adjustment
Iron Deficiency flag mechanism QFLA Adjustment mechanism

PLT Abn Suspectable QFLA Adjustment


Distribution flag mechanism QFLA Adjustment mechanism

Suspectable QFLA Adjustment


Platelet clumps flag mechanism QFLA Adjustment mechanism

4-11
5 Error Information of the Analyzer

5.1. Error Code


5.1.1. Pressure Testing

Error ID Error Name Error Mechanism Troubleshooting and Solution


Pressure control The generated pressure 1. Check if the wires between the
0x01000601 error of the is out of the set pressure drive board and main board, wires
pressure chamber range between the main board and the
Pressure control The generated pressure analog signal board are connected
0x01000602 error of the is out of the set pressure properly, check if the pipe of the
vacuum chamber range pressure sensor on the analog signal
Pressure value of board is reliable.
the pressure The pressure test is out 2. Check if the pressure and vacuum
0x01000605
chamber is out of of set range chamber is installed correctly.
range 3. Click the "Remove error" button or
check if the status is OK in the
self-test screen, see if the error is
removed;
Pressure value of 4. Restart to see if it is normal.
the vacuum Out of the set range of 5. Check if the valve and pump work
0x01000606
chamber is out of pressure test properly.
range 6. If the problem cannot be solved,
the pressure sensor may be
ineffective, change the Analog signal
board.

5.1.2. Temperature Module

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
1. Check if the version information
of the drive MCU and FPGA are
correct;
The Reaction bath
Abnormal 2. Check if the temperature of the
temperature does not
temperature of reaction bath is within the range of
0x01003030 meet the design
the Reaction [34.5,31.5]℃;
requirements in the
bath The temperature is 0℃, the input
sequence design.
end of the photocoupler is short
circuit, the sensor maybe
damaged or the wires are

5-1
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
short-circuit
If the temperature value is 70℃,
confirm as the actual temperature
A. If yes, replace the drive board
B. If the input end of the sensor is
open circuit, the sensor maybe
damaged or the wires are not well
connected
3. If the temperature is lower than
the minimum range, confirm as the
heating light. If the light is on
constantly, confirm that the
heating wire is OK, otherwise the
heater is damaged, replace the
components
1. Check if the version information
of the drive MCU and FPGA;
2. Check if the actual temperature
Environment
Environment of the device is within the range of
temperature is
temperature is out of the [15,30]℃;
0x1003031 out of the range
range of work 3. Check if the wires of the
of work
environment temperature sensor are connected
environment
properly;
4. Replace the connecting wires of
the temperature sensor.
1. Check if the version information
of the drive MCU and FPGA are
correct;
2. Check if the actual temperature
of the device is within the range of
[10,40]℃;
The temperature is 0℃, the input
end of the photocoupler is short
0x1003032 circuit, the sensor maybe
damaged or the wires are
short-circuit
Environment If the temperature value is 70℃,
temperature is confirm as the actual temperature
out of the Environment A. If yes, replace the drive board
running temperature is out of the B. If the input end of the sensor is
environment running environment open circuit, the sensor maybe
range range damaged or the wires are not well

5-2
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
connected
3. Check if the wires of the
temperature sensor is OK;
4. Check if the wires and the
heater are OK;
5. Change the wires of the
temperature sensor.
1. Check if the version information
of the drive MCU and FPGA are
correct;
2. Check if the optical temperature
of the reaction bath is within the
range of [30,40]℃;
The temperature is 0℃, the input
end of the photocoupler is short
circuit, the sensor maybe
damaged or the wires are
short-circuit
Laser diode temperature If the temperature value is 70℃,
Laser diode
0x01003033 is out of the run confirm as the actual temperature
temp. abnormal
environment range A. If yes, replace the drive board
B. If the input end of the sensor is
open circuit, the sensor maybe
damaged or the wires are not well
connected
3. If the temperature is lower than
the minimum range, confirm as the
heating light. If the light is on
constantly, confirm that the
heating wire is OK, otherwise the
heater is damaged, replace the
components
1. Check if the version information
of the drive MCU and FPGA are
correct;
2. Check if the temperature is
Abnormal
Abnormal diluent within the range of [25,36]℃;
0x0100041D diluent
temperature If the temperature is higher than
temperature
36 ℃ , check if the diluent
temperature is within the range of
[25,33]℃;
The temperature is 0℃, the input

5-3
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
end of the photocoupler is short
circuit, the sensor maybe
damaged or the wires are
short-circuit
If the temperature value is 70℃,
confirm as the actual temperature
A. If yes, replace the drive board
B. If the input end of the sensor is
open circuit, the sensor maybe
damaged or the wires are not well
connected
3. If the temperature is lower than
the minimum range, confirm as the
heating light. If the light is on
constantly, confirm that the
heating wire is OK, otherwise the
heater is damaged, replace the
assembly

5.1.3. Syringe Module


 Errors occur at the user end

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
1. The initialization has The photocoupler may be
passed the photocoupler damaged or the resistance of
area, but the photocoupler is the motor assembly is too
still blocked; large, which results in the
2. The initialization has step missing or drive error.
Sampling syringe
0x01000301 returned to the photocoupler Low possibility.
photocoupler error
area, but the photocoupler is 1. Check if the software and
not blocked; hardware versions are
3. The reset shall not be at correct, and if the 24V, 12V
the initial position, but the and 5V power is normal;
photocoupler is blocked 2. Check if the wires of the
Sampling syringe It has returned to the initial photocoupler and motor are
0x01000302 aspirate and drain position theoretically, but the reliable, check if there is bad
action error 1 photocoupler is not blocked; connection of the plug;
Sampling syringe It is not in the initial position 3. Click the "Remove error"
0x01000303 aspirate and drain theoretically, but the button to see if the error can
action error 2 photocoupler is blocked; be removed;
0x01000304 Sampling syringe It shall be in the initial 4. Perform self-test at the

5-4
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
does not permit the position theoretically when self-test screen to see if the
aspirate and drain starts the action, but the error is removed;
action 1 photocoupler is not blocked; 5. See if the
Sampling syringe It shall not be in the initial LED(ASP-M3_LED2;
does not permit the position theoretically when SP-M4_LED2,
0x01000305
aspirate and drain starts the action, but the SH-M5_LED2,
action 2 photocoupler is blocked; DIL-M6_LED2,
1. The initialization has LYSE-M7_LED2) of relevant
passed the photocoupler light flashes during the motor
area, but the photocoupler is action. If not, replace the
still blocked; drive board;
2. The initialization has 6. Check if the photocoupler
Sampling syringe
0x01000311 returned to the photocoupler is OK: see if there is any
photocoupler error
area, but the photocoupler is changes of status when it is
not blocked; blocked or not;
3. The reset shall not be at 7. Remove the bad
the initial position, but the photocoupler and check if
photocoupler is blocked there is dusts to block the
Sampling syringe It has returned to the initial luminous surface or if there
0x01000312 aspirate and drain position theoretically, but the is fluids on the luminous
action error 1 photocoupler is not blocked; surface of the photocoupler;
Sampling syringe It is not in the initial 8. Wipe the photocoupler
0x01000313 aspirate and drain position theoretically, but the surface and see if the error is
action error 2 photocoupler is blocked; removed after the

Sampling syringe installation, if not, replace the


It has returned to the initial
does not permit the photocoupler;
0x01000314 position theoretically, but the
aspirate and drain 9. See if the installation of
photocoupler is not blocked;
action 1 the syringe assembly is OK;

Sampling syringe 10. If the error is not


It is not in the initial position
does not permit the removed, replace the
0x01000315 theoretically, but the
aspirate and drain relevant syringe assembly.
photocoupler is blocked;
action 2
1. The initialization has
passed the photocoupler
area, but the photocoupler is
still blocked;
Sheath fluid syringe 2. The initialization has
0x01000321
photocoupler error returned to the photocoupler
area, but the photocoupler is
not blocked;
3. The reset shall not be at
the initial position, but the

5-5
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
photocoupler is blocked
Sheath fluid syringe It has returned to the initial
0x01000322 aspirate and drain position theoretically, but the
action error 1 photocoupler is not blocked;
Sheath fluid syringe It is not in the initial position
0x01000323 aspirate and drain theoretically, but the
action error 2 photocoupler is blocked;
Sheath fluid syringe
It has returned to the initial
does not permit the
0x01000324 position theoretically, but the
aspirate and drain
photocoupler is not blocked;
action 1
Sheath fluid syringe
It is not in the initial position
does not permit the
0x01000325 theoretically, but the
aspirate and drain
photocoupler is blocked;
action 2
1. The initialization has
passed the photocoupler
area, but the photocoupler is
still blocked;
2. The initialization has
Hemolysin syringe
0x01000331 returned to the photocoupler
photocoupler error
area, but the photocoupler is
not blocked;
3. The reset shall not be at
the initial position, but the
photocoupler is blocked
Hemolysin syringe It has returned to the initial
0x01000332 aspirate and drain position theoretically, but the
action error 1 photocoupler is not blocked;
Hemolysin syringe It is not in the initial position
0x01000333 aspirate and drain theoretically, but the
action error 2 photocoupler is blocked;
Hemolysin syringe
It has returned to the initial
does not permit the
0x01000334 position theoretically, but the
aspirate and drain
photocoupler is not blocked;
action 1
Hemolysin syringe
It is not in the initial position
does not permit the
0x01000335 theoretically, but the
aspirate and drain
photocoupler is blocked;
action 2
Diluent syringe 1. The initialization has
0x01000341
photocoupler error passed the photocoupler

5-6
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
area, but the photocoupler is
still blocked;
2. The initialization has
returned to the photocoupler
area, but the photocoupler is
not blocked;
3. The reset shall not be at
the initial position, but the
photocoupler is blocked
Diluent syringe It has returned to the initial
0x01000342 aspirate and drain position theoretically, but the
action error 1 photocoupler is not blocked;
Diluent syringe It is not in the initial position
0x01000343 aspirate and drain theoretically, but the
action error 2 photocoupler is blocked;
Diluent syringe
It has returned to the initial
does not permit the
0x01000344 position theoretically, but the
aspirate and drain
photocoupler is not blocked;
action 1
Diluent syringe
It is not in the initial position
does not permit the
0x01000345 theoretically, but the
aspirate and drain
photocoupler is blocked;
action 2

 Low possibility to occur at user end


Troubleshooting and
Error ID Error Name Error Mechanism
Solution
1. Action time conflicts in the The errors mainly occur
Sample Syringe is sequence; during the R&D debugging,
0x01000300
working 2. Transmitting time error of when error occurs at the user
the software end, the main reason is time
1. Action time conflict in the command conflict, click the
Sampling syringe sequence; "Remove error" button, if the
0x01000310
is working 2. Transmitting time error of error is not removed, please
the software restart the device. Other
1. Action time conflict in the special troubleshooting is not
Sheath fluid sequence; required.
0x01000320
syringe is working 2. Transmitting time error of
the software
1. Action time conflict in the
Hemolysin
0x01000330 sequence;
syringe is working
2. Transmitting time error of

5-7
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
the software
1. Action time conflict in the
Diluent syringe is sequence;
0x01000340
working 2. Transmitting time error of
the software
Aspirate volume set by the
Aspirate volume sequence is out of range
of the sampling Use during the R&D phase
0x01000306
syringe is out of If occurs at the user end, it
range indicates software or
program error
Drain volume set by the
sequence is out of range
Drain volume of
It is use during the R&D
the sampling
0x01000307 phase
syringe is out of
If it occurs at the user end, it
range
indicates software or
program error
If the error occurs at the
Sampling syringe
0x01000308 user end, it is the software
action overtime
bug
Aspirate volume set by the
Aspirate volume sequence is out of range
of the Sample Use during the R&D phase
0x01000316
Injection Syringe If occurs at the user end, it
is out of range indicates software or
program error
Drain volume set by the
Drain volume of sequence out of range
the Sample Use during the R&D phase
0x01000317
Injection Syringe If occurs at the user end, it
is out of range indicated software or
program error
Sample Injection If the error occurs at the
0x01000318 Syringe action user end, it is the software
overtime bug
Aspirate volume set by the
Aspirate volume sequence out of range
of the Sheath fluid Use during the R&D phase
0x01000326
syringe out of If occurs at the user end, it
range indicated software or
program error

5-8
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
Drain volume set by the
Drain volume of sequence is out of range
the sheath fluid Use during the R&D phase
0x01000327
syringe is out of If occurs at the user end, it
range indicated software or
program error
Sheath fluid If the error occurs at the
0x01000328 syringe action user end, it is the software
overtime bug
Aspirate volume set by the
sequence is out of range
Aspirate volume
It is use during the R&D
of the hemolysin
0x01000336 phase
syringe is out of
If occurs at the user end, it
range
indicates software or
program error
Drain volume set by the
sequence is out of range
Drain volume of
It is use during the R&D
the hemolysin
0x01000337 phase
syringe is out of
If occurs at the user end, it
range
indicates software or
program error
Hemolysin If the error occurs at the
0x01000338 syringe action user end, it is the software
overtime bug
Aspirate volume set by the
Aspirate volume sequence out of range
of the Diluent Use during the R&D phase
0x01000346
syringe out of If occurs at the user end, it
range indicated software or
program error
Drain volume set by the
sequence is out of range
Drain volume of It is use during the R&D
0x01000347 the diluent syringe phase
is out of range If occurs at the user end, it
indicates software or
program error
If the error occurs at the
Diluent syringe
0x01000348 user end, it is the software
action overtime
bug

5-9
Error Information of the Analyzer

5.1.4. Sampling assembly module


Troubleshooting and
Error ID Error Name Error Mechanism
Solution
If it fails to move to the 1. Check if each software
correct position and hardware version is
horizontally, it indicates correct, check if the 24V,
horizontal motor action 12V and 5V voltage is
error or photocoupler error normal;
are as follows: 2. When checking the error,
1. The wires of position ensure that the relevant
X motor failed to
photocoupler or horizontal wires of the error are
0x01000201 move to target
motor are damaged connected properly, such as
position
2. Position photocoupler if the inner wires of the
error sample assembly are
3. Horizontal motor error reliable, if the labels of
4. Board error sensor wires match the
5. Larger resistance of the sensor positions, if the labels
sampling assembly of motor wires match the
horizontally motor position.
It shall move to the initial 3. Click the "Remove error"
position horizontally, but button;
the photocoupler is not 4. Click X or Y motor
blocked, it indicates the self-test button at the
horizontal motor action self-test screen to see if the
error or photocoupler error error is removed;
The reasons are as follows: See if the LED (X-M1_LED2;
X motor
1. The wires of position Y-M2_LED2) of relevant light
initialization fails
0x01000202 photocoupler or horizontal flashes during the motor
to move to initial
motor are damaged action. If not, replace the
position
2. Position photocoupler drive board;
error 6. Check if the photocoupler
3. Horizontal motor error is OK: check if the status of
4. Board error the two photocouplers at X
5. Larger resistance of the direction and one
sampling assembly photocoupler at Y direction
horizontally change when blocked or not
It shall leave the initial blocked;
position during the 7. Remove the bad
X motor
initialization, but the photocoupler and check if
initialization fails
0x01000203 photocoupler testing is still there is dusts to block the
to leave the initial
in the initial position, it luminous surface or if there
position
indicates the horizontal is fluids on the luminous
motor action error or surface of the photocoupler;

5-10
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
photocoupler error 8. Wipe the photocoupler
X motor adjusting The same as 0x201 error, it surface and see if the error
0x01000204 does not move to only occurs during the is removed after the
target position position adjusting process installation, if not, replace
If fail to move correct the photocoupler;
position vertically, it 9. If it is not removed, check
indicates the vertical motor if the motor fails to move to
action error or photocoupler position
photocoupler error are as because of step missing or
follows: clogging. (Low possibility, it
1. The wires of position seldom happens).
Y motor failed to
photocoupler or horizontal
0x01000211 move to target
motor are damaged
position
2. Position photocoupler
error
3. Horizontal motor error
4. Board error
5. Larger resistant of the
sampling assembly
vertically
It shall move to the initial
position vertically, but the
photocoupler of the initial
position is not blocked, it
indicates the vertical motor
action error or
Y motor
photocoupler error are as
initialization fails
0x01000212 follows:
to move to up
1. Vertical initial position
position
photocoupler error
3. Vertical motor error
4. Board error
5. Larger resistance of the
sampling assembly
vertically
It shall move from the initial
position vertically, but the
Y motor
photocoupler of the initial
initialization fails
0x01000213 position is blocked, it
to move to lower
indicates the vertical motor
position
action error or
photocoupler error are as

5-11
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
follows:
1. The wires of position
photocoupler or horizontal
motor are damaged
2. Position photocoupler
error
3. Horizontal motor error
4. Board error
5. Larger resistance of the
sampling assembly
vertically
Y motor The same as 0x211 which
adjustment fails to appears during the position
0x01000214
move to the target adjustment process and
position can be merged
Y motor
adjustment does
0x01000215
not return to the The same as 0x212 and
up position can be merged
If horizontal motor moves
in the following condition,
report the error:
X motor does not
0x01000223 1. The position
permit the action
photocoupler is blocked
2. Vertical initial position
photocoupler is not blocked
If the position is blocked,
Y motor does not
0x01000226 the vertical motor is
permit the action
working , report the error
The motor cannot drive the
Y motor does not sample probe to pierce the
0x01000228 pierce to the lower cap, when the sample
position probe returns to the up
position, error is reported
During the initialization, it
Horizontal initial shall return to the
position horizontal initial position,
0x01000231
photocoupler but the photocoupler at the
error horizontal initial position is
not blocked
Photocoupler on It shall return to the vertical
0x01000235
the sample probe initial position vertically, but

5-12
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
error the vertical initial position
photocoupler is not blocked
1. It only appears at the
position adjusting process
2.Check if the process,
adjusting process and if the
When adjusting the adjustment to the target
Y motor Adjusting position, if the vertical position are correct
0x01000218
Steps out of limit adjusting is out of the limit, 3.If the above items are all
it shall be readjust correct, check if the sample
assembly are correct
4.If the above items are all
correct, replace the sampling
assembly
1. It only appears at the
position adjusting process
2.Check if the adjusting
process and if the
When adjusting the adjustment to the target
X motor Adjusting position, if the vertical position are correct
0x01000208
Steps out of limit adjusting is out of the limit, 3.If the above items are all
it shall be readjusted correct, check if the sample
assembly are correct
4.If the above items are all
correct, replace the sampling
assembly
RBC position right 1. The error only occurs after
0x0100027E edge of the gap the position adjustment and
out of limit exit the screen
RBC position left 2. If 272-274, 277-278 or
0x01000272 edge of the gap 27E errors are reported,
out of limit check the installation of the
WBC position At the corresponding sampling assembly, if there
0x01000273 right edge of the position, the edges of is no problem, replace the
gap out of limit relevant position sampling assembly
WBC position left photocoupler are too close 3. If other errors are
0x01000274 edge of the gap reported, adjust the relevant
out of limit position
DIFF position right 4. If the error is still reported,
0x01000275 edge of the gap check if the adjusting
out of limit process and the adjustment
0x01000276 DIFF position left to the target position are

5-13
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
edge of the gap correct
out of limit 5. If the above are all correct,
Right edge of the check if the sampling
0x01000277 open-vial position assemblies are installed
gap out of limit correctly
Left edge of the 6. If the above are all correct,
0x01000278 open-vial position replace the sampling
gap out of limit assembly
During the adjustment, the
adjustment transmission is
Y motor adjusting Remove error, restart the
0x01000217 not reported at No. 0-6
position error analyzer failed
position, it is considered
not to occur at the user end
Disorder position
adjustment command
Y motor end Remove error, restart the
0x01000219 order transmission, it is
position error analyzer failed
software error, the software
shall be restarted
During the adjustment, the
adjustment transmission is
X motor adjusting Remove error, restart the
0x01000207 not reported at No. 0-9
position error analyzer failed
position, it is considered
not to occur at the user end
Disorder position
adjustment command
X motor end Remove error, restart the
0x01000209 order transmission, it is
position error analyzer failed
software error, the software
shall be restarted
1. Action time conflict in the
sequence;
The sample probe 2. Transmitting time error of It happens accidentally,
0x01000220
is working the software remove the error directly
3. Drive program count
error
If the initialization is not Remove error, restart the
The sample probe
started, perform left or right analyzer failed
does not permit
0x01000221 and up and down
adjustment
adjustment and adjustment
of the software bug
If the error occurs at the Remove error, restart the
X motor action
0x01000222 user end, it is the software analyzer failed
overtime
bug

5-14
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
If the error occurs at the
Y motor action Remove error, restart the
0x01000225 user end, it is the software
overtime analyzer failed
bug

5.1.5. Power voltage


Troubleshooting and
Error ID Error Name Error Mechanism
Solution
24V power Out of the range: Low possibility of circuit status
0x010030A3
voltage abnormal [22,30]V error
1. Check if the version
information is correct;
2. Check if the wires between
power board and each board
are OK;
12V power Out of the range:
0x010030A4 2. If outlet of relevant power is
voltage abnormal [11.4,12.6]V
OK, if the power is not within
the range, replace the power
3. Remove the error
4. If it can be removed,
replace the drive board

5.1.6. Analog signal board module


Troubleshooting and
Error ID Error Name Error Mechanism
Solution
+ 12v analogue Out of the range: Low possibility of circuit status
0x010030A1
voltage abnormal [11.4,12.6]V error
1. Check if the version
information is correct;
2. Check if the wires between
power board and each board
are OK;
- 12v analogue Out of the range: 2. If outlet of relevant power is
0x010030A2
voltage abnormal [-12.6,-11.4]V OK, if the power is not within
the range, replace the power
3. Remove the error
4. If it cannot be removed,
replace the Analog signal
board
1. First check if the versions of
The voltage monitor
56V power CPU, versions of main control
0x010030A0 value does not meet the
voltage abnormal board FPGA are correct
design requirements
2. Check if the wires of the

5-15
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
Analog signal board J8 are
connected properly;
3. Take out the wire
connectors of the J8 Analog
signal board;
4. Test the TP48 voltage with
the multimeter, if exceed the
range of 1.206V~1.474V,
replace the Analog signal
board;
5. If it does not exceed the
range, replace the J8 wires
(C-009-002228-00), connect
the J8 and click the "Remove
error" button
6. If the error cannot be
removed, replace the main
control board
1. First check if the versions of
CPU, versions of main control
board FPGA are correct
2. Check if the wires are
connected reliably, check if
there are scratching or
damage of the wires, the wires
include:
C-009-002226-00 control
wires of the optical system
During the HGB
C-009-002228-00 low-speed
measurements, the
Laser diode wires of the main control
0x01003061 current of laser board
current Analog signal board
does not meet the
C-009-002229-00 digit wire of
design expectation
the main control analog signal
board
3. Check if the analog signal
board is normal
a. Check if the analog signal
board TP32 is smaller than
0.1V, if yes, it indicates Analog
signal board error
b. Check if the power supply of
the laser control board is

5-16
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
normal: J1.1:[-12.6,-11.4]V;
J1.4:[11.4,12.6]V, if not,
replace the wire
C-009-002226-00, if it is still
not within the range, it
indicates analog signal board
error, replace the analog
signal board;
4. Check if the laser control
board is normal
a. Check if the TPILD voltage
of the laser control board is
within the range of 1.2V~4.5V,
if not, replace the laser control
board, test again, if the value
is still not within the range, it
indicates optical system error,
replace it
b. Check if the switch control
of the laser control is normal:
J1.6:5V;J1.5<0.8V, if it is
within the range, replace the
laser control board; Test
again, if not, it indicates the
optical system error, replace it
5. Check if the main control
board is normal
a. Check if the J8.9 voltage of
the analog signal board and
the TPILD voltage of the laser
control board, if yes, replace
the wire C-009-002228-00, if
the error still exists, it indicates
the main control board error,
replace it; if not, replace the
wire C-009-002226-00
b. Replace the wire
C-009-002229-00, if the error
still exists, it indicates the main
control board error, replace it
Open the side 1. Check if the right-side door
0x010030D0 Open the right side door
door of the can be opened, if yes, close

5-17
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
analyzer the door and remove the error;
2. If the error is reported when
the door is closed, check the
installation of the micro-switch,
see if the photocoupler can be
pressed when the door is
closed;
3. Check if the wires of the
micro switch are reliable and
see if they are damaged;
4. See if the micro switch is
OK: see if the status changed
when pressed or ejected the
micro switch;
5. If the error is not removed,
replace the photocoupler.
1. Check if the optical system
is locked tightly, if yes, close
the door and remove the error;
2. If the error is reported when
the door is closed, check the
installation of the micro-switch,
see if the micro switch can be
pressed when the door is
The optical
The optical assembly is closed;
0x010030D1 assembly is
loosen 3. Check if the wires of the
opened
micro switch are reliable and
see if they are damaged;
4. See if the micro switch is
OK: see if the status changed
when pressed or ejected the
micro switch;
5. If the error is not removed,
replace the micro switch.

5.1.7. Reagent test type


Troubleshooting and
Error ID Error Name Error Mechanism
Solution
Test if the diluent
Click the "Reagent" button,
reagent is expired after
0x01003070 Expired reagent load the valid reagent
starting up and 10:00
information
every morning

5-18
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
Test if the LH reagent is Click the "Reagent" button,
0x01003071 HGB lyse expired expired after starting up load the valid reagent
and 10:00 every morning information
Test if the LEOI reagent
Click the "Reagent" button,
is expired after starting
0x01003072 DIFF1 lyse expired load the valid reagent
up and 10:00 every
information
morning
Test if the LEOII reagent
Click the "Reagent" button,
is expired after starting
0x01003073 DIFF2 lyse expired load the valid reagent
up and 10:00 every
information
morning
0x01003096 Diluent insufficient 1. The software records
the remain reagent is
Click the Remove error
less than -20% of the
button, load the new valid
total amount;2.The
reagent in the prompt reagent
hardware reports there is
box and perform reagent
no reagent, the software
replacing
records the remain
reagent is less than 3%
0x01003097 HGB lyse 1. The software records
insufficient the remain reagent is
Click the Remove error
less than -20% of the
button, load the new valid
total amount;2.The
reagent in the prompt reagent
hardware reports there is
box and perform reagent
no reagent, the software
replacing
records the remain
reagent is less than 3%
0x01003098 DIFF1 lyse 1. The software records
insufficient the remain reagent is
Click the Remove error
less than -20% of the
button, load the new valid
total amount;2.The
reagent in the prompt reagent
hardware reports there is
box and perform reagent
no reagent, the software
replacing
records the remain
reagent is less than 3%
0x01003099 DIFF2 lyse 1. The software records
insufficient the remain reagent is Click the Remove error
less than -20% of the button, load the new valid
total amount;2.The reagent in the prompt reagent
hardware reports there is box and perform reagent
no reagent, the software replacing
records the remain

5-19
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
reagent is less than 3%
1. Check if the waste
container is full;
2. Check if the float sensor is
at reliable floating status.
3. Check if the wires and
0x01003085 Waste full Waste full connectors of the waste
sensor is OK.
4. Check if the connector of
the waste sensor on the drive
board is OK;
5. Replace the waste sensor
1. Check if the diluent
container is full;
2. Check if the float sensor is
at reliable floating status.
3. Check if the wires and
connectors of the diluent
sensor is OK.
4. Check if the connector of
the diluent sensor on the
drive board is OK;
0x01003080 No diluent No diluent 5. Replace the diluent float
sensor.
6. Check if the wires between
the reagent testing board and
the driver board are
connecting reliably and
properly;
7. Check if the reagent
sensor is OK;
8. Replace the reagent
testing board
0x01003081 No HGB lyse No HGB lyse 1. Check if the reagents are
0x01003082 No DIFF1 lyse No DIFF1 lyse used up;
2. Check if the wires between
the reagent testing board and
the driver board are
connecting reliably and
properly;
3. Check if the reagent
0x01003083 No DIFF2 lyse No DIFF2 lyse sensor is OK;

5-20
Error Information of the Analyzer

Troubleshooting and
Error ID Error Name Error Mechanism
Solution
4. Replace the reagent
testing board

5.1.8. Flow cell clog


Error
Error ID Error Name Troubleshooting and Solution
Mechanism
1. If the error cannot be removed by clicking the
remove error button, it indicates the photocoupler
of the relieve valve is blocked, the following
treatments are recommended:
1. a Ensure that it is not under the development
access, if yes, change the access and perform
fluidics initialization
1. b Check if the photocoupler of the relieve valve
is blocked,
1.b.1 If yes, disconnect the pipe at both ends of
the relieve valve
1.b.1.1 If it is still blocked, it indicates the relieve
valve error, please replace it
1.b.1.2 If not, the relieve valve is normal, there
may be error in other places
During the 1.b.2 If not, it indicates the circuit error, it maybe
sequence photocoupler or wires problems
running 1. C Check if there are errors at the pinch valve
0x01000611 Flow cell clog
process, the PV28 and its pinch pipes move the pinch valve
relieve valve is manually and see if the pinch pipe is folded.
block/not block 1. D Check if the fluids adding inlet of the DIFF
bath is clogged. If error is reported after
continuous testing, this step can be skipped, if
error is reported after startup, or there is
maintenance in the previous period or there is
error untreated before shutting down, which need
to be confirmed. Perform probe cleaner soak for
5 min
1.e Check if the valve V15 can be opened and
closed normally, or the tube TT39 and T40 are
folded
2. If the error can be removed, but "Flow cell clog"
error is reported in the next count
2.a It is recommended to perform flow cell
unclogging and DIFF channel Probe Cleanser
Maintenance, if the error still exists, it is

5-21
Error Information of the Analyzer

Error
Error ID Error Name Troubleshooting and Solution
Mechanism
recommended to perform per the order of the
suggestions.
2.b The valve V18 cannot be opened normally or
it is clogged or the pipes around the V18 is
folded, pay special attention to the T24 and T22;
2.b The valve V17 cannot be opened normally or
it is clogged or the pipes around the V17 is
folded, pay special attention to the T26;
2.c The flow cell is clogged by the foreign
materials, draw out the flow cell manually with the
syringe, if the device is installed recently or it is
place still for a long time, it is suggested to check
this item.
2.c The reset of the relieve valve is too small, the
cover is damaged and the spring is rusted, if the
device is installed recently or it is place still for a
long time, it is suggested to check this item.

5.1.9. Background abnormal


Troubleshooting and
Error ID Error Name Error Mechanism
Solution
1. If it is the diluent error,
ensure that there is no
2. If the analyzer has
been idle for a long time
The background test and cannot be shut down
during the startup with other abnormal
Background
0x01002000 exceeds the range operation, please perform
abnormal
specified in the Fluidics probe cleanser
corporate standard. maintenance and Fluidics
cleaning
3. If the user can operate
the device normally,
perform fluidics cleaning.

5-22
Error Information of the Analyzer

5.1.10. HGB abnormal


Troubleshooting
Error ID Error Name Error Mechanism
and Solution
1. When the count starts, the
HGB voltage exceeds the range
HGB blank voltage of [3.2V, 4.9V].
0x01003060 /
abnormal 2. When the device is idle, the
HGB voltage exceeds the range
of [3.2V, 4.9V].

5.1.11. Clog
Error ID Error Name Error Mechanism Troubleshooting and Solution
0x01002010 WBC Clog 1. Perform "Zap Apertures", "Flush
Apertures" and "Unclog" operation for
During the counting several times.
process, all or part of 2. If the clog error cannot be removed,
the apertures are perform "Probe Cleanser
clogged, which results Maintenance".
in the aperture flow 3. If the clog error cannot be removed,
0x01002030 RBC Clog
become slower and add the probe cleanser into the bath
aperture voltage higher directly and soak for 10 minutes.
which report the clog 4. If the clog error cannot be removed,
error. then take off the aperture and soak it in
the probe cleanser and clean the
aperture manually.

5-23
6 Fluidic System

6.1. Analysis Flow


The fluidic system of the analyzer contains 3 analyzing channels.
 DIFF & optical channel
 WBC&HGB channel
 RBC&PLT channel
The system flow chart of whole blood CD mode is as follows: (there is no DIFF or optical
channel of the CBC mode)

Figure 6-1 Fluidic system flow chart (whole blood CD mode)

The system flow chart of predilute CD mode is as follows: (there is no DIFF or optical channel
of the CBC mode)

6-1
Fluidic System

Figure 6-2 Fluidic system flow chart (predilute CD mode)

6.1.1. WBC&HGB channel


WBC analysis

Reagents used:

M-53LH lyse: dissolves RBC, PLT, and differentiates basophils from other WBCs by size.
Diluent: cleans the system, and provides environment for reaction and analysis.

Analysis principle: the impedance method

Analysis parameters: WBC, BASO#, BASO%

Graph information: WBC histogram

Dilution ratio: 1:500*1

Analysis duration: 12s

Analysis pressure: -32kpa

Measuring volume: the measuring volume is controlled by controlling the vacuum and analysis
duration. The stability of vacuum shall be ensured so that the aperture flow can be stable, thus
the measuring volume can be calculated by controlling the analysis duration.

1 Dilution ratio in this chapter refers to the dilution ratio of whole blood mode, if not otherwise
stated.

6-2
Fluidic System

Function description: 6μl of blood, 2.5ml of diluent and 0.5ml of LH lyse are mixed and reacted
in the counting bath, and then the compound is aspirated into the back bath via the aperture by
vacuum of the vacuum chamber, the cells are analyzed when they passes the aperture.

HGB analysis

Reagents used:

Diluent: for dilution and cleaning


LH lyse: dissolves RBCs and bonds HGB

Analysis principle: colorimetric method

Analysis parameter: HGB

Dilution ratio: 1:500

The analysis principle of HGB channel is colorimetric method. By comparing the scatter light
intensity of the diluent and the sample, the HGB concentration can be obtained.

6.1.2. DIFF & optical channel


Reagents used:

LEO(I), LEO(II) lyse: dissolves RBCs, and differentiates WBCs.


Diluent: for cleaning and forming of sheath fluid.

Analysis principle: flow cytometry, semi-conductive laser scatter method

Analysis parameter: MONO#, MONO%, LYMPH#, LYMPH %, NEUT#, NEUT%, EOS# and
EOS%.

Graph information: 4-DIFF scattergram

Dilution ratio:1:138

Analysis duration: 16s

Analysis flow: 0.0077216ml/s

Measuring volume: the sample flow is stable, by controlling the analysis duration, the
measuring volume can be calculated.

Function description: 0.6ml of Leo(I) lyse is dispensed to wash the DIFF bath, then 1.1 ml of
Leo(I)lyse is added before 9μl of blood is dispensed. 0.135ml of Leo(II) lyse is added after the
blood and Leo(I) react for a while. After a while again, the sample will be delivered to below the
flow cell, the sheath fluid syringe is started to form sheath fluid, and the sample syringe is
started to push the sample into the flow cell for analysis.

6.1.3.RBC/PLT channel
Reagents used:

Diluent: for dilution, cleaning, providing conducting environment and isometric processing of
cells.

Analysis principle: the impedance method

6-3
Fluidic System

Analysis parameters: RBC, PLT

Graph information: RBC histogram, PLT histogram

Dilution ratio:1:20000

Analysis duration: 16s

Analysis pressure: -32kpa

Measuring volume: the measuring volume is controlled by controlling the vacuum and analysis
duration. The stability of vacuum shall be ensured so that the aperture flow can be stable, thus
the measuring volume can be calculated by controlling the analysis duration.

Function description: the sample probe aspirates 52.08μl of sample (dilution rate: 1: 417.7)
from the WBC bath; the sample probe moves to RBC bath to mix the sample with 2.5ml of
diluent, the dilution rate of the sample is1:20000. The sample is then aspirated into the bath
back through the aperture by vacuum of the vacuum chamber, the cells are analyzed when
they pass the aperture.

6.2. Sample Volume

Table 6-1 Sample volume

Whole blood Capillary


Item Predilute mode
mode blood mode

Dilute 20uL of blood manually: 180uL of


CD mode 20L 20L
diluent, aspirate 80L
Dilute 20uL of blood manually: 180uL of
CBC mode 15L 15L
diluent, aspirate 40L

6.3. Temperature Control of the Fluidic System

Table 6-2 Temperature control of the fluidic system

Preheating
Item Optical system Reaction bath
bath

Target temperature ℃ 30 35 36

Alarming temperature ℃ ±6 ±5 ±1.5

6-4
Fluidic System

6.4. Reagent Volume

Table 6-3 reagent volume

Probe
diluent LEO(I) LEO(II) lyse LH lyse
Loading mode cleanser
(ml) (ml) (ml) (ml)
(ml)

CBC 32 0 0 0.5 0
Whole blood mode
CD 42 1.7 0.14 0.5 0

CBC 31 0 0 0.5 0
Predilute mode
CD 41 1.7 0.14 0.5 0

Shutdown 208 1.25 1.25 1.2 3.6

Normal startup 83 2 2 2 0

Startup after abnormal shutdown 130 3 3 3 0

Exit from standby status 1 13 0 0 0 0

Exit from standby status 2 65 0 0 0 0

Exit from standby status 3 98 0 0 0.25 0

6.5. Introduction of Fluidic Components


This section introduces the fluidic components and their functions, the symbols refers to the
symbols in the fluidic diagram.
6.5.1. Mindray valves
 Symbols:

Two way Mindray valve Three way Mindray valve

 Appearance:

wo way Mindray valve Three way Mindray valve

6-5
Fluidic System

Pin-lift

 Function:

Two-way valve: connects and disconnects channels. When the electromagnetic valve is
not electrified, the input and output ports are blocked; when the electromagnetic valve is
electrified, the input and output ports are connected.
Three-way valve: switches channels. When the electromagnetic valve is not electrified,
the common port and normally open port are connected; when the electromagnetic valve
is electrified, the common port and normally closed port are connected.

 Note: the working voltage of the Mindray valve is 12V, and the maximum pressure
is 200KPa. The Mindray valve works via the electromagnet, and restores by using
spring, it shall not be electrified for long term. When the electromagnetic valve is
electrified, the pin-lift of the valve goes down; when the valve is not electrified, the
pin-lift restores. By touching the pin-lift, you can feel its movement to judge its
status.

6.5.2. Two-way pressureproof Mindray valve


 Symbols:

Same as the two-way valve

 Appearance:

 Function: pressure resistance of the two-way pressureproof Mindray valve is


greater than that of the ordinary two-way Mindray valve, their operating principle is
the same.

 Note: Be sure to distinguish the ordinary two-way valve and the pressureproof
two-way valve when replacing the valves.

6-6
Fluidic System

6.5.3. LVM fluidic valve


 Symbols:

Same as the Mindray valves

 Appearance:

Two-way LVM fluidic valve Three-way LVM fluidic valve

 Function:

same as the Mindray valves. The pressure resistance of this valve is greater than that of the
two-way pressureproof Mindray valve, so it can adapt to greater temperature and pressure
change.
 Note: pressure resistance 200KPa, CV of the flow is about 0.03.
6.5.4. Pinch valve
 Symbols:

PV28

 Appearance:

 Function: clamp type, on/off controlled by electromagnetic power. The valve controls the
flow and break of fluid.
6.5.5. Liquid filter
 Symbols:

6-7
Fluidic System

 Appearance:
LF1 LF2

 Function: filters the impurities in diluent.


 Note: LF1 is probe wipe filter, LF2 is sheath fluid filter.
6.5.6. Syringes
 Symbols:

A A
A

100ul/250ul 2.5ml 10ml

 Appearance: N/A.
 Function: There are 5 types of syringes, there parameters and functions are as follows:

Table 6-4 List of syringe parameters and functions

Name Label Specification Function


The syringe aspirates fixed amount of
Aspirate Full range
Asp-Syringe blood sample and diluted sample, and
syringe 100μl
dispense the sample.
The syringe dispenses fixed amount of
Diluent
Dil-Syringe Full range10ml diluent to the WBC and RBC bath, provides
syringe
diluent to the probe wipe, and clean the

6-8
Fluidic System

Name Label Specification Function

sample probe and counting bath.


Full range
2.5m l, 3
Lyse The syringe dispenses M-53Leo(I),
Lyse-Syringe syringe tubes
syringe M-53Leo(II) and M-53LH lyse.
are driven by
one motor.
The syringe pushes sheath fluid into flow
cell, cleans the flow cell, prepares sample
Sheath
and cleans the DIFF bath and inside of the
fluid Sh-Syringe Full range10ml
sample probe. It aspirates and dispenses
syringe
probe cleanser in probe cleanser
maintenance procedure.

Sample Full range The syringe pushes sample into the flow
Sp-Syringe
syringe 250μl cell for measurement.

6.5.7. Pressure pump


 Symbols:

GP
 Appearance:

 Function: provides pressure to the pressure chamber.

6.5.8. Vacuum pump


 Symbols:

LP2

LP3

 Appearance:

6-9
Fluidic System

 Function:

LP2: the pump drains the DIFF bath and vacuum chamber, and generates vacuum of the
vacuum chamber.

LP3: the pump drains the probe wipe, WBC bath and RBC bath.

6.5.9. Sample probe


 Symbols:

 Appearance:
Open vial sample probe

 Function: provides a corrosion resistant cavity, which is able to aspirate and dispense
blood and probe cleanser.
Note: the probe tip of open vial sample probe is flat.

6.5.10. Probe wipe


 Symbols:

6-10
Fluidic System

 Appearance:

Open vial probe wipe


Function: provides a cavity to clean open vial sample probe under the effect of liquid flow,
and to collect the waste produced.
 Note:The open vial probe wipe is consisted of 2 parts.

6.5.11. Pressure relief valve


 Symbols:

RV

 Appearance:

6-11
Fluidic System

Block
Photocoupler plate

 Function: detects the pressure in the sheath fluid channel, when the pressure goes
beyond specified range, the photocoupler will be blocked, and alarm signal will be given.

6.5.12. Baths
WBC bath: the WBC bath is formed by the front bath, back bath and aperture. The bath
provides space for WBC sample mixing and reaction, HGB and WBC measurement.

RBC bath: the RBC bath is formed by the front bath, back bath and aperture. The bath provide
space for RBC sample mixing and reaction, RBC/PLT measurement.

DIFF reaction bath: provides space for DIFF sample mixing and reaction, and provides
prepared DIFF sample.

Vacuum chamber: generates and stores stable vacuum for WBC and RBC impedance
counting, cleans the back bath, and drains the flow cell when it is clogged to remove
impurities.

Pressure chamber: generates and stores stable pressure for bubble generation of the baths
and aperture flushing.

WBC isolating chamber: provides room to block interference signals from outside.

RBC isolating chamber: provides room to block interference signals from outside.

6-12
Fluidic System

6.6. Introduction of Fluidic Structure


See the following fluidic structure diagram:
1 2 3 4 5 6 7 8
MRSZ/R05N01.291.01(2.0)

SV18

C84 (T23)
C15 J19-T24-J20
J44-T174-J45 T175 C81 C80 C45 C49 DILUENT
T170 T169 T4
J1-T11-J2 DIL
A T25 C14 C46 C50 LEO(I) LYSE
T7 T3
LEO(I)
C83 C1 C47 C51 LEO(II) LYSE
DIFF bath T2
SV17

J40-T15-J12
T6

J39-T14-J11
LEO(II)
C2 C48 C52 LH LYSE

J17-T22-J18
LF2
C12 C13 C77 T5 T1

T164
J3-T12-J4 LH

T131
Flow

Fold the strip to fasten it


T173
J25-T26-J26

(T21)
T30 T31 T29

T27
T28

T49
cell Reagent
SV04 SV05 SV06
RV Transducer detection

T136
SV15
GF1 T70
C37
PV28

T172
T73 -T132
J7-T39-J8 J21-T40-J22

T171
T16

T10

T8
T134
C82 T133 T71 T72 PC

T9
J16-T17-J41
T33

C26 T43 T135 C41

J5-T18-J6
T38 C25 GP C16 T74
J23-T42-J24
T32

J15
SV16
SV14 GF2
J42-T165-J43

B T35
C28
T36
C27
C3

J9-T13-J10
T34

T75-T76
SV10
T37

C29
T41

C4 C30
T19 J13-T20-J14

T77
SP(250uL)
T45

Isolating C68
T47

SH(10mL)

chamber1

T155
LYSE(2.5mLX3)
C5
SV08 SV09

J35-T139-J36
J33-T138-J34
J31-T137-J32
T156

T140
C78 T68
C64 T166
Transducer

T78
C42 C69 C24
T149

C36 C17
T46 T60

T146 Fold the strip to fasten it


SV13 T80
C79
T167

T79
C18
T150

C T62

T81
T168
C19

T82
C67

T146
T64
C65

T83
T48

T152
T57

T153

C8 C38

T66

T69
C44 T50 T63
DH T61
SV07 名称: VC
T162 ASP(100uL)

T65
C66
T151 T58
T59
T54

SV01 SV03 SV02 TS


SV22 SV19
(T148)

C75 C76

T154
T163

T53
T55

T67
T51

J37-T52-J38

T84
T108
T96

C9
T56

C20 RBC C22 SV20


D WBC SV21 T104 C33

T85
T92
C32 T102
T90 T106
T94 C73 C74
(T147)

T95 T107

T161
T160
C53 C54 C55 C59
DIL(10mL)

T103
T91 SV27 SV26 C56 C57 C58 C60

LEO(II) reagent
T93 T105

LEO(I) reagent
C23

LH reagent
C21

container

container

T143
container
T87

T141

T142

T144
J29-T101-J30
J27-T89-J28

(T100)

Bath shielding
(T88)

Bath shielding C31 T86


SPB cover SV12 cover SV11
T127

T126
Isolating T97 T109 T111 C34
Isolating
LF1 chamber 2 T98 T110

T112
chamber 3
T123

Probe T113
wipe
T99

T114 C35
C62 C61
E C72 C70
C71
T159

T157

SV23
T158

SV25 SV24
T145

T130

T117
T122

C63 C39
C10 T118 T115
T128 T120 T119 C40
LP2
Waste C43 C11
T129 T121 T116
container
LP3

F 保密:此图及其全部知识产权(含著作权)归深圳迈瑞生物医疗电子股份有限公司所有。未经深圳迈瑞生物医疗电子股份有限公司预先书面许可,严禁出于任何目的,对此图的全部或部分内容(包括但不限于图中信息、数据、运算结果等)泄露、使用、拷贝或复制。
Classified documents, This set of drawing(s) and all it's intellectual property rights (including copyright) subsisting herein are property of Shenzhen Mindray Bio-medical Electronics Co.,Ltd. No disclosure,use,copies or reproductions
should be made of this drawing or any part(s) thereof for whatever purpose nor shall any information, data, calculations, or other contents contained in this drawing be disseminated without prior written permission of Shenzhen Mindray
Bio-medical Electronics Co.,Ltd

6.6.1. Sample aspiration and dispensing channel


The structure of the sample aspiration and dispensing channel is as follows:

6-13
Fluidic System

C36

T45
T46
SV14 Diluent
SV13

T57
C64 SV01 SV03 SV02

T150
C65

T149

T163
C76 T53
T34 T55

T48
T47
C44 T50

T56
C27

J37-T52-
J38
T35

T51

T162 ASP(100uL)
C28
T36

DIL(10mL)
C29
T37

T127
C75
SPB
SH(10mL)

T123
T126
LF1 Waste
Probe pump
wipe

Major functions:
1. Sample aspiration and dispensing. The ASP syringe and sample probe SPB works
together to aspirate 20uL of blood, and dispenses 9uL, 6uL and 52.08uL of blood sample
respectively.
2. Cleaning inside and outside of the sample probe. Cleaning inside of the sample probe
can be done by DIL syringe, SV01, 02, and 03 valves working together, it can also be done by
SH syringe, SV13 and 14 valves working together. Cleaning outside of the sample probe is
done by DIL syringe, SV02 and 03 valves working together. Waste is collected by the probe
wipe and waste pump.
3. Aspiration and dispensing probe cleanser. When aspirating probe cleanser, SV13 and
SV14 is electrified, the SH syringe aspirates 3.6mL of probe cleanser from the sample probe
SPB. The probe cleanser is stored in the reservoir T47 (marked in red in the figure above).
When dispensing probe cleanser, the sample aspirating assembly delivers the sample probe
to the reaction baths (DIFF, WBC and RBC bath), SV13 and SV14 is electrified, the SH syringe
dispenses certain amount of probe cleanser to the counting bath.

6.6.2. WBC&HGB channel


The structure of the WBC&HGB channel is as follows:
The blue lines are the flowing paths of diluent, the peach lines are the flowing paths of lyse,
and the wine lines are the sample flowing paths (this rule applies to all following figures in this
chapter).

6-14
Fluidic System

C67

T153
T152

J9-T13-
J10
DH T58
SV07 C2
C66
T151
T54
SV01 SV03 SV02
T5 C52 C48
T53 T1
T55

T49
SV04
WBC

J31-T137-
T56 C20 SV22
T92
C32 Diluent

J32
T90 Reagent

T10
T96

T61
T94
detection
T57

T91 SV21Vacuum
Diluent T93 T95
C21
T62chamber C53
DIL(10mL)

C56
Bath shielding
J27-T89-
Pressur
(T88)

SV12 e
J28
cover

container
LH lyse

T141
chamber
T114
Waste
T97 SV23
Isolating pump

T157

T117
T99
T98 LYSE(2.5mLX3)
chamber 2 C70

6.6.3. WBC analysis


The diluent syringe dispenses diluent into the WBC bath along the blue paths, the sample
probe dispenses blood sample into the WBC bath, and the lyse syringe dispenses LH lyse into
the WBC bath along the peach paths. The sample, diluent and lyse are mixed by bubbles
generated by the pressure chamber via SV12, and aspirated into the back bath by vacuum via
the aperture (wine lines). The calls are measured when they pass the aperture, and the
sample volume is calculated from the analysis duration. After analysis, the WBC bath is
drained by SV23 and the waste pump.

6.6.4. HGB analysis


The analysis principle of the HGB channel is colorimetric method. By comparing the intensity
of the transmitted light through the background and the blood, the HGB concentration can be
obtained. The intensity of the transmitted light through the diluent is detected first, and during
WBC analysis, the intensity of the transmitted light through the blood sample is detected, the
ratio of the two intensity values is the HGB result.

6.6.5. DIFF & optical channel


The structure of the DIFF & optical channel is as follows:

6-15
Fluidic System

C15 J19-T24- J1-T11-


SV17 J20 J2

C13 T25 C14 C46 C50


SV18 T7 T3

J39-T14 -
T31 T28 T29

J11

J40-T15-
LF2 DIFF bath C1 C47 C51
T6

J12
J25-T26- T2

T131
(T21)
J26 J3-T12 -
SV0 SV0

J35-T139-
C12 C48 C52

T27
J4
6

J36
C77 Flow 5

T164
T30

J17-T22-
cell

J33-T138-
Reagent

J18

T8
T9

J34
RV SV15 detection
T32

J7-T39- PV28

J42-T165-
J8 J21-T40- T16 C54 C55
SV14

J43
J22 T44 C57 C58
T34 J16-T17-

LEO(I) reagent
T33

C26 T43
J41 C25
Diluen T45

container
C29

container
reagent

T143
LEO(II)

T142
J23-T42-

J5-T18 -
T35
T38

J24

J6
t

C28

T41
T36
C27 SV16
T37
T47

LYSE(2.5mLX3)
C64
SV1
T149

SP(250uL) 0
SV08

C4 J13-T20- Pressure

T69
T19
SH(10mL)

J14 chamber
T68
SV13 Waste

T160
Isolating

T87
chamber 1 pump
SV27
T166
Pressure
chamber

Leo(I) lyse is dispensed into the DIFF bath by lyse syringe via T11, Leo(II) lyse is dispensed
into the DIFF bath by lyse syringe via T12. Bubbles are dispensed from the pressure chamber
to DIFF bath via SV10, after reaction, the sample is transmitted under the flow cell. The sheath
fluid syringe is started to form sheath fluid along the blue lines in the figure. The sample is
driven to the flow cell for analysis by the sample syringe. After the analysis, the sheath fluid
syringe cleans the flow cell and sample preparing tubes along the blue lines in the figure. The
DIFF bath is drained by waste pump and SV27.

6.6.6. RBC/PLT channel


The structure of the RBC/PLT channel is as follows:

C67
T153
T152

DH T58
SV07
C66
T151
T54
SV01 SV03 SV02
T53
T55

RBC C20 SV19


T56

T92
C32 Diluent
T90
T96

T61

T94
T57

T91 SV20Vacuum
Diluent T93 T95
C21
T62chamber
DIL(10mL)

Bath shielding
J27-T89-

Pressur
(T88)

SV11 e
J28

cover
chamber
T114
Waste
T97 SV24
Isolating pump
T157

T117
T99

T98
chamber 2 C70

6-16
Fluidic System

The diluent syringe dispenses diluent into the RBC bath along the blue paths, the sample
probe dispenses diluted blood sample into the RBC bath. The sample and diluent are mixed by
bubbles generated by the pressure chamber via SV11, and aspirated into the back bath by
vacuum via the aperture (wine lines). The calls are measured when they passes the aperture,
and the sample volume is calculated from the analysis duration. After analysis, the RBC bath is
drained by SV24 and the waste pump.

6.7. Introduction of Sequences


The sequences of open vial whole blood CBC+DIFF mode will be introduce as an example.

6.7.1. Analysis sequences of open vial whole blood CBC+DIFF mode


The diagram of the analysis sequences is as follows.

6-17
Fluidic System

0 5 10 15 20 25 30 35 40 45 50 55 60

SNH-MOTOR SNH-MOTOR

SNV-MOTOR SNV-MOTOR
15.2 15.8 18.3 51.1

Sample probe
+20 5 7.6 20.2 12.5 22.95
ASP- +2 14 +2 5
-9 11 -0.5 3 -6 5 -9 14 +52.08 ASP-
14 INIT 14
SYRINGE SYRINGE
V01 22.85 25.45 V01
V03 14.5 20.1 25.8
2.1 6.1 9.4 10.8 V03
16.9 21.9 27.6
V02 47.5
2.1 6.1 9.4 27.6 43.8 45.6 V02
51.1
V13 15 16.8 V13
V07 17.4 19 49.4 51.1 V07
V25 2.2
9.1 10.7 14.1 17.4 19.7 22.4
25.4
56 59 V25
6.6 6. 25.9 2827.2 38
2 2.5 5.7 9.55 11.6 14.6 16.1 17.5 20.2 22.95 +200 43.8 46.2 47.6 49.6
-2150 6 6 -1300 -700 6 8
+100 8 +6100 -1647.92 -800 2 INIT 13
DIL-SYRINGE +4700 13-150 8
13 -2500 -600 5 -450 6 10 7
+2300 -4100 13 DIL-SYRINGE
-800 6 10 +8550 10 -4100 13
15. 15. 16. 17. 19.7 13
6.7 43.7 45.3 46.8 49 50.7
3.7 1 7 2 2 5
SH-SYRINGE -300 -450 -7758 2
+1900 10
-1290 7
-1900 +1650 10 INIT 7 SH-SYRINGE
+1200 3 8
+8500 15 7 +250 7
-150 8 +150 8
7
V16 0 3.6 20.6 21.2 46.7 47.4 V16
V15 43.6 V15
17.15 19.7 46.7 48.6 50.6 53.2
45.2
V14 15 16.7 17.15 19.7
20.05
46.7 48.6 50.6 53.2 V14
45.2
V17 20.05 48.6 50.6 53.2 V17
V18 20.3 V18
42.7
V28 0 3.8
19.6 V28
0.3 42
4 51.1
DIFF 20.5 21.8
-140 2
INIT 5
SP-SYRINGE +190 12 SP-SYRINGE
+20 14 -60 14
0 2.8 4.2 6.7 12 15 17 20.7 40 49.6 50.7
LYSE- -145 14 INIT 5
+2000 14
-1100 14 +600 11 +50 5 +20 1 LYSE-
-600 -10 11 -50 9 -520 11
SYRINGE SYRINGE
14
V06 2.8 3.8 6.6 8.7 V06
V05 4.1 4.7 11.9 13 49.5 50.6 V05
V27 0 1.5 4.5 6
25.4
23.5 35.2 40.5 46.7 48.6 49.6 V27
27.7
V10 8.1 V10
13.9
DIFF_COUNT 34 DIFF_COUNT
50
V23 6.6 42.2 45.4 V23
9.1 43.8 47.6
V12 13.5 V12
4.6 5.1 20.5 23.6 44.9 45.4
16.1
V04 20.6 21.7 V04
V22 53.65 56.5 V22
WBC V21 26.2
53.65 56.5 V21
42.1
WBC_COUNT 28.9 WBC_COUNT
40.9
HGB_BLANK 2.5 HGB_BLANK
HGB_PARA 41 HGB_PARA
V24 12 48.1
V24
14 49.4
V11 25.8 56.2 V11
26.25 57.1
RBC V19 54 56 V19
V20 26.2
54 56 V20
48
RBC_COUNT 32.1 RBC_COUNT
46.1
V09 57.2 59.5 V09
V26 55.8 V26
58.2
PUMP_PRES PUMP_PRES
S 57.2 59.3 S
BUILD_PRES BUILD_PRES
Public SPUMP_VA
0
25.3
44.5 45.5 54.5 57 S
40.5 55.5
PUMP_VA
C 0 1.5 4.5 6 25.2 27.5 33.5 35 48.6 49.6 C
46.7 58.5
BUILD_VAC 8 12
16.5 22.1 49.6 BUILD_VAC
22 25 55.3
PUMP_WAST 1 25.4 41.7 PUMP_WAST
E 19.7 22.4 56 59
17.4 27.5 51 E
CONST 19 CONST
49
SELECT_WBC 18 SELECT_WBC
SELECT_RB SELECT_RB
Zap C 18 C
ZAP_WBC 50 ZAP_WBC
53
ZAP_RBC 51.2 ZAP_RBC
54

6-18
Fluidic System

0~1.9sAspirate 20uL of blood sample from the sample probe with the ASP syringe
0~2sAspirate 4700uL of diluent from the diluent container with the DIL syringe
2~2.3s The DIL syringe discharges 150uL of diluent to eliminate hysteresis error.
0~2.7sThe lyse syringe aspirates 2000uL of lyse (including LEO(I), LEO(II) and LH lyse)
0~1.5sStart vacuum pump LP3 to drain the DIFF bath
0~17.4sStart waste pump LP2 to drain probe wipe waste pipe, RBC bath and WBC bath
0~25.3s Generate and maintain pressure in the pressure chamber

6-19
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37

T34 C3
J42-T165-

C29 C28
0
J43

T75-T76
C4 J13-T20-
T19
T41

J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

C44 T50 C8 C38


T63
T57

T153

DH
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS

T66
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96

C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

cover J30 C31 T86


SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23
T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
LP2
Waste C43 C11
T129 T121 T116
container
LP3

6-20
Fluidic System

3~5.2sThe sample probe returns to inside of the probe wipe


2.5~5.6sClean outside of the sample probe with DIL bath, the waste pump is pumping waste during the process
2.8~3.8sOpen V06 valve, dispense 600uL of LEO(I) lyse into the DIFF bath with the lyse syringe
3.7~6.6sAspirate 5800uL of diluent with the SH syringe
4.5~6sStart vacuum pump LP3 to drain the DIFF bath

6-21
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
T126 T125 C34
( ( Isolating T97 Isolating T109 T111
T124

T98 chamber 3 T110


chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T159
T145

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
LP2
Waste C43 C11
T129 T121 T116
container
LP3

6-22
Fluidic System

6~6.5sSample aspirating assembly moves to the upper position of the DIFF bath
6.6~7.6sThe sample probe goes down to the DIFF bath
6.7~8.7sDispense 1100uL of LEO(I) lyse into the DIFF bath with the lyse syringe
7.7~8.2sThe sample probe wiggles
7.6~8.7sDispense 9uL of blood sample into the DIFF bath with the ASP syringe
8.1~13.9Turn on and off V10 continuously to generate bubbles to mix the sample in DIFF bath
6.6~9sAspirate 6100uL of diluent with the DIL syringe

6-23
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27

Fold the strip to fasten it


Reagent

T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
T126 T125 C34
( ( Isolating T97 Isolating T109 T111
T124

T98 chamber 3 T110


chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
LP2
Waste C43 C11
T129 T121 T116
container
LP3

6-24
Fluidic System

9.2~10.2sThe sample probe returns to inside of the probe wipe


9.5~10.8sClean the outside of the sample probe with probe wipe and the DIL bath

6-25
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
T126 T125 C34
( ( Isolating T97 Isolating T109 T111
T124

T98 chamber 3 T110


chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-26
Fluidic System

10.8~11.3The sample aspirating assembly moves to upper position of the WBC bath
11.4~7.6sThe sample probe goes down to the WBC bath
12.5~14.2sThe sample probe wiggles
12.5~13.5sDispense 6uL of blood sample into the WBC bath with the ASP syringe
13.5~16.1sTurn on and off V12 continuously to generate bubbles to mix the sample in WBC bath
11.6~13.1sDispense 2500uL of diluent into the WBC bath with the DIL syringe
12~13sDispense 135uL of LEO(II) lyse into the DIFF bath with the lyse syringe

6-27
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-28
Fluidic System

14.4~15.4sThe sample probe returns to inside of the probe wipe


14.6~15.7sClean outside of the sample probe with probe wipe and the DIL syringe
16.1~16.9sClean outside of the sample probe with probe wipe and the DIL bath
15.1~16.2sClean inside of the sample probe with the SH syringe
15~9sAspirate 600uL of lyse with the LYSE syringe

6-29
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten ir


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-30
Fluidic System

17.2~18.3sThe sample probe goes down to the WBC bath


18.3~20.2sAspirate 52.08uL of diluted sample with the ASP syringe
17.5~19sDispense 1648uL of diluent into the RBC bath with the DIL syringe
17.2~19.7Aspirate 1200uL of sample from the DIFF bath with the SH syringe, sample preparation process
19sSwitch to the constant current source
16.5~22sGenerate vacuum in the vacuum chamber for the first time

6-31
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-32
Fluidic System

20.3~21.3sThe sample probe returns to inside of the probe wipe


20.2~21.9sClean outside of the sample probe with probe wipe and the DIL syringe
20.7~21.8sDispense 500uL of LH lyse into the WBC bath with the LYSE syringe
20.5~23.6sTurn on and off V12 continuously to generate bubbles to mix the sample in WBC bath
19.75~43.7sThe SH syringe generates sheath fluid in the flow cell
20.5~21.5sThe SP syringe pushes the sample in reservoir into the flow cell rapidly
21.8~41sThe SP syringe pushes the sample in reservoir into the flow cell to flow stable sample flow

6-33
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-34
Fluidic System

21.4~22.1sSample aspirating assembly moves to the RBC bath


22.2~23.2sThe sample probe goes down to the RBC bath
22.93~25.1sASP syringe is initialized, and the 52.08uL of diluted sample in the sample probe is added to the RBC bath
22.95~25.2sDispense 800uL of diluent into the RBC bath with the DIL syringe
24~40sPerform DIFF analysis in the flow cell
25.8~26.3sTurn on and off V11 continuously to generate bubbles to mix the sample in RBC bath
22.1~25sGenerate vacuum in the vacuum chamber for the second time

6-35
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten ir


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-36
Fluidic System

25.7~26.8sThe sample probe returns to inside of the probe wipe


25.9~27sClean outside of the sample probe with the DIL syringe
25.4~27.5sStart waste pump LP2 to drain probe wipe waste pipe
22.5~27.5sStart vacuum pump LP3 to drain the DIFF bath
26.9~28sThe sample aspirating assembly moves to upper position of the WBC bath
26.2~42.1sOpen V21 to deliver fluid in the WBC front bath to the back bath through the aperture
28.9~40.9sWBC analysis
26.2~48sOpen V20 to deliver fluid in the RBC front bath to the back bath through the aperture
32.1~46.1sRBC analysis
33.5~35.2sStart waste pump LP3 to drain the DIFF bath

6-37
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
T126 T125 C34
( ( Isolating T97 Isolating T109 T111
T124

T98 chamber 3 T110


chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-38
Fluidic System

38~43sAspirate 8550uL of diluent with the DIL syringe


40.5~46.7sStart waste pump LP3 to drain the DIFF bath
42.2~43.8Turn on waste pump LP2 to drain WBC bath
41~42sMeasure HGB reference voltage

6-39
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1

T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)
chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-40
Fluidic System

43.8~45.6sDispense 4000uL of diluent into the WBC bath with the DIL syringe
44.9~45.4sTurn on and off V12 continuously to generate bubbles in WBC bath
43.7~45.3sClean sample preparing tubes and DIFF bath with the SH syringe
45.4~47.6sStart waste pump LP3 to drain the DIFF bath

6-41
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37

T34 C3
J42-T165-

C29 C28
0
J43

T75-T76
C4 J13-T20-
T19
T41

J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96

C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30 C31 T86


cover SV12 cover SV11
LF1
C6
T126 T125 C34
( ( Isolating T97 Isolating T109 T111
T124

T98 chamber 3 T110


chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23
T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-42
Fluidic System

45.3~46.7sAspirate 1900uL of diluent with the SH syringe


46.2~47.6sAspirate 2300uL of diluent with the DIL syringe
47.1~48.1sThe ASP syringe generates 2uL of separating bubbles in the sample probe

6-43
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37

T34 C3
J42-T165-

C29 C28
0
J43

T75-T76
C4 J13-T20-
T19
T41

J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Foldthe strip to fasten ir


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96

C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

Bath shielding (T100)


(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Sample T126 T125 C34
Isolating T97 Isolating T109 T111
T124

Probe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23
T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-44
Fluidic System

47.6~49.6sDispense 4000uL of diluent into the WBC bath with the DIL syringe
46.8~48.7sClean sample preparing tubes and DIFF bath with the SH syringe
48.6~49.6sStart waste pump LP3 to drain the DIFF bath
48.1~49.4Turn on waste pump LP2 to drain RBC bath

6-45
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37

T34 C3
J42-T165-

C29 C28
0
J43

T75-T76
C4 J13-T20-
T19
T41

J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96

C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

Bath shielding (T100)


(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-46
Fluidic System

49~50.6sAspirate 1500uL of diluent with the SH syringe


49.6~51.1sInitialize the DIL syringe and dispense 800uL of diluent into the RBC bath

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-47
Fluidic System

50.7~52.8sThe SH syringe dispenses 1500uL of diluent into the DIFF bath through sample preparing tubes
51.1~523.1sSP syringe initialization
50.7~52.7sLYSE syringe initialization
53.65~56.5sClean back bath of the WBC bath
54~56sClean back bath of the RBC bath
56.2~57.1sTurn on and off V11 continuously to generate bubbles in RBC bath

6-48
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37
T34 C3

J42-T165-
C29 C28
0

J43

T75-T76
C4 J13-T20-
T19

T41
J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96
C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30
C31 T86
cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23

T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-49
Fluidic System

55.8~58.2sOpen V26 and waste pump LP3 to drain the vacuum chamber
57.2~59.5sOpen V09 to release pressure in the pressure and vacuum chamber.
57.2~59.3sStart the pressure pump to help release vacuum of the vacuum chamber

6-50
Fluidic System

SV18
(T23)
J19-T24- J1-T11-
C15
J2
C45 C49 DILUENT
J20 T4
T25 C14 C46 C50 LEO( I( LYSE
T7 T3
LEO(I)
DIFF bath J3-T12 - C1 C47 C51 LEO( II( LYSE
T6

J39-T14 -
T2

J40-T15-
SV17 J4
LEO(II)

J17-T22-
(T21)

J11

J12
LF2 C2 C48 C52 LH LYSE

J18
C12 C13 T5 T1
J25-T26- C77 Flow LH

T164
T30 T31 T28 T29

T131
J26 cell

T27
Reagent

Fold the strip to fasten it


T49
RV SV15 SV0 SV0 Transduc detection
SV04
5 6 er
GF1

T136
T70
J21-T40- PV28

T10

T8
J7-T39-J8

T9
J22 T16 C37 T73 -T132
T44 T134
C26 J16-T17- T72 PC
T43 T133 T71
T33

T38 J41
T32

C25

J5-T18 -
T135C41 C16
SV14 SV16 GP T74

J6
J23-T42-

J9-T13-
J24

J15
J10
T36 C27 GF2
T35 SV1
T37

T34 C3
J42-T165-

C29 C28
0
J43

T75-T76
C4 J13-T20-
T19
T41

J14
T45

SP(250uL)
C30
Isolating LYSE(2.5mLX3)

T77
SH(10mL)

chamber 1
T47

C68

T140
T155
SV08
T68
C5
C78
SV09

J31-T137-

J33-T138-

J35-T139-
T156
C64 T166

J32

J34

J36
T149

Transducer

T78
C42 C69 C24
SV13

T146 Fold the strip to fasten it


T80
C17
C36 T167
C79
T46 T60
T150

C18

T79
T62

T168
C65

T82

T81
T146
C67 C19
T64

T83
T48

T69
T152

T153

C44 T50 C8 C38


T63
T57

DH

T66
SV07

T61
VC
T162 ASP(100uL)

C66 T65
T151 T58
T59 SV19
T54
SV01 SV03 SV02 TS
C75 C76 SV22

T154
T53
T163

T67
T55
J37-T52-
(T148)
T51

J38

T84
T108
T56

T96

C9
RBC C22 SV20 C73
WBC C20 SV21

T85
T92 T104 C33
C32 T102
T90 T106

T160
T94 C74
(T147)

T161
T95 T107
SV27 SV26 C53 C55 C59
C54
DIL(10mL)

T91 T103
C56 C57 C58
T127

T93 T105 C60

LEO(I) reagent
C21 C23

LH reagent

T144
container

container
T87

container
reagent

T143
LEO(II)
T141

T142
J29-T101-
J27-T89-

(T100)
Bath shielding
(T88)

SPB Bath shielding


J28

J30 C31 T86


cover SV12 cover SV11
LF1
C6
Probe T126 T125 C34
Isolating T97 Isolating T109 T111
T124

wipe
T98 chamber 3 T110
chamber 2 T112

T113
T99

C7
T114 C35
T123

C62 C61
C70
C72 C71
T157
T145

T159

SV23
T158
SV25
SV24
T130

T117
T122

C63
C10
T128 T120 T119 T118 T115
C39 C40
Waste LP2
C43 C11
containe T129 T121 T116
r LP3

6-51
Fluidic System

6.7.2. Analysis sequences of open vial predilute CBC+DIFF mode


The analysis sequences of open vial predilute CD mode are almost the same as those of the
whole blood mode, the only difference is:
1.Samples of the predilute mode are diluted before presented to the analyzer, the sample
aspiration volume is 80uL, and 40uL of sample is dispensed to the WBC and RBC bath
respectively.

6.7.3. Analysis sequences of the CBC mode


The analysis sequences of CBC mode does not involve fluidic actions of the DIFF & optical
channel, their differences from the analysis sequence of CD mode are:
1. Sample aspiration volume. The sample aspiration volume of whole blood CD and CBC
mode is 20uL and 15uL respectively; and the sample aspiration volume of predilute CD and
CBC mode is 80uL and 40uL respectively.
2. No actions related to the DIFF bath, including dispensing of blood, LEO(I) and LEO(II) lyse,
DIFF bath bubbling and cleaning.
3. No actions related to the flow cell, including sample preparation, sheath fluid, sample flow,
sample preparing tube cleaning, etc.

6.8. Function of Fluidic Valves

Name Function
Works with SV03 and SV07 to control the liquid dispensing
SV01
direction of DIL syringe
SV02 Controls the liquid aspiration and dispensing of DIL syringe
Works with SV01 and SV07 to control the liquid dispensing
SV03
direction of DIL syringe
Works with LYSE syringe to control the aspiration and
SV04
dispensing of LH lyse
Works with LYSE syringe to control the aspiration and
SV05
dispensing of LEO(II) lyse
Works with LYSE syringe to control the aspiration and
SV06
dispensing of LEO(I) lyse
Works with SV01 and SV03 to control the liquid dispensing
SV07
direction of DIL syringe
SV08 Works with the vacuum chamber to flush and drain the flow cell

SV09 Connecting vacuum and pressure chamber

SV10 Controls bubble generation of DIFF bath

6-52
7 Optical System

7.1. Overview of Optical System Principle


The optical system principle is based on that of the flow cytometer: when the stained cells pass
the facula detection area under the influence of "Hydrodynamic focusing", light scatter is
produced after exposure of the a cell under light beam, where the forward scatter reflects the
volume of the cell, and the side scatter reflects the complexity of the nucleus. Therefore,
BC-5300 is able to differentiate different cells by collecting and analyzing the forward scatter
and side scatter, and presents the result using 2D scattergram. The optical system is
composed of the laser radiation module and scatter sensors.

7.2. Optical Path and Workflow of the Optical System


The optical path of optical system is shown in Figure 7-1.

13

12

11

1 2 3 4 5 6 7 8 9 10

Figure 7-1 Optical path of optical system

1.Semiconductor laser (670nm) 2.Laser collimating lens


3.Cylindrical lens A 4.Cylindrical lens B
5.Flow cell 6.Posterior collimating lens
7.Light splitter 8.Forward scatter diaphragm
9.Forward scatter focusing lens 10.Forward scatter PD
11.Side scatter diaphragm 12.Side scatter focusing lens
13.Side scatter PD 14./

The optical system uses semiconductor laser (1) as the source of light, which emits a red laser
beam of 6670nm. The laser beam passes through the collimating lens and gets collimated,
and then adjusted by cylindrical lens A (3) and B (4) which are placed orthogonally, to form a
flat elliptic laser beam of 15um*300um (@13.5%) going through the sample flow (6) in the
center of the flow cell (5).

7-1
Optical System

Figure 7-2 Laser facula through the flow cell

After the sample probe releases the white blood cells treated with reagent, the sheath flow
wraps the cells and makes them passing through the flow cell one by one, as shown in Figure
7-2. The flat elliptic laser beam irradiate light on each white blood cell passing through the flow
cell( the red line shown in Figure 7-1).
After the light scatter comes out of the flow cell (5), it is collimated by posterior collimating lens
(6) into parallel light, and then split by the light splitter (7) into 2 scatter beams which are the
same in dimension. The forward scatter split by the light splitter passes through a forward
scatter diaphragm (8) and becomes the 2-5 degree scatter, and is then focused on the forward
scatter PD by the forward scatter focusing lens (9); the side scatter split by the light splitter
pass through a side scatter diaphragm (11) and becomes the 8-20 degree scatter, and is then
focused on the side scatter PD by the side scatter focusing lens.
The forward scatter and side scatter are transferred to electric signals by the PD, which are
then processed by the signal processing system based on which the 2D scattergrams are
generated, and thus the 5-part differentiation of white blood cells are achieved.

7.3. Components of the Optical System


The figure below shows the components of BC-5300 optical system, and the name of the
components are listed in Table 7-1.

7-2
Optical System

Figure 7-3 Components of BC-5300 optical system

Table 7-1 Components of BC-5300 optical system

1 Front optical assembly 7. Side scatter diaphragm


assembly
2 Flow cell measurement 8. Side scatter PD assembly
assembly
3 Rear optical assembly 9. Laser control board
4 Light splitter lens assembly 10. Rear cover assembly
5 Forward scatter diaphragm 11. Base plate assembly
assembly
6 Forward scatter PD assembly 12. /

7.4. Optical System Status Determination


The BC-5300 optical system status is determined using 7um standard particle. The operation
procedures and determination criteria are as follows:
1. Get a vial of 7μm standard particles, mix it by shaking the vial gently, and then dispense
3-4 drops into a 1.5ml centrifugal tube. Dilute the solution in the centrifugal tube to 1ml,
cap the tube and mix it well to prepare the standard particle solution for status
determination, as shown in Figure 7-4;

7-3
Optical System

Figure 7-4 Preparing the 7um standard particle solution

2. Select the venous whole blood mode (open-vial) for sample analysis, and run the 7um
standard particle. After the analysis is completed, select the analysis data in the "Review"
screen, and then click the "Optical" button on top right to go to the optical adjustment
screen, as shown in Figure 7-5.

Figure 7-5 Optical adjustment screen of standard particle


3. Select "Standard Particle Mode", and then click "Calculate". Check if the "FS Gravity
Center Position" falls in the range of 17.6±0.5, and "SS Gravity Center Position" 105.3±1.0.
If not, enter the FS peak target (17.6) and SS peak target (105.3) in the "Peak Target"
fields, and then the instrument will automatically calculate the gain. Click the "Gain Setup"
button to apply the gain;
4. At the "Run" screen, run the 7un particle solution again, and then check the "FS Gravity
Center Position" and "SS Gravity Center Position" against the ranges mentioned above.
Repeat Step 2-4 until these 2 values falls in the respective range.
5. If the "FS Gravity Center Position" and "SS Gravity Center Position" of particle 1 meet the
requirements, check if the following requirements are met:
FS 0.1max Width (SD) ≤6.8
SS 0.1max Width (SD) ≤15
Check if the FS and SS gains displayed on the "Gain" setup" (Setup>General

7-4
Optical System

Setup>Gain) meet the following requirements:


FS Gain ≤150
SS Gain ≤220
6. If the requirements are met, the optical system status determination is finished, and the
result is Pass. If the requirements are not met, see the next section below.

7.5. Maintenance and Replacement of the Optical System


When the optical system test using standard particle fails or when error occurs, service is
needed. Service of BC-5300 optical system includes maintenance and replacement, where
maintenance refers to the cleaning, wiping procedures when there is no component damage,
and replacement generally refers to the replacement of the whole optical system when there is
component damage or maintenance failure (considering the shortage of service tools and the
complexity of the service procedures).
7.5.1. Maintaining the Optical System
The maintenance of optical system is usually used when there are errors like flow cell clog.
See the details below.
 Flow cell exterior wall needs cleaning
 Error presentation: the gravity center in the scattergram descends, FS and SS values in
the gain setup screen slightly high, and the dots in the scattergram are more sporadic (but
still in a normal distribution).
 Error confirmation: open the top cover and right door using a cross-headed screwdriver,
loosen the 6 screws fixing the optical system shielding cover to remove the cover. Check
along the laser beam to see if there is brightened dot on the exterior wall of the flow cell.

Spot of light on
the exterior
wall of the flow
cell

Figure 7-6 Brightened dot on the exterior wall of the flow cell

 Troubleshooting: if evident brightened dot is found, wipe the place with dust-free cloth
dipped with anhydrous alcohol until the dot disappears.
 Note:
1. Avoid direct eye contact with the laser beam in the maintenance process;
2. Do not touch the radiation-proof diaphragm or damage the flow cell assembly while
wiping;
3. Check if there is any evident brightened dot on the exterior wall of the flow cell after
wiping.

7-5
Optical System

 Flow cell interior wall needs cleaning


 Error presentation: abnormal DIFF scattergram. The figures below show examples of
abnormal scattergrams of normal blood sample and standard particle.

Figure 7-7 Scattergram of normal blood sample when the flow cell interior wall needs
cleaning

Figure 7-8 Scattergram of standard particle when the flow cell interior wall needs
cleaning

 Error confirmation: open the top cover and right door using a cross-headed screwdriver,
loosen the 6 screws fixing the optical system shielding cover to remove the cover. Check if

7-6
Optical System

there is brightened dot on the interior wall of the flow cell. At the meantime, place a white
paper before the side scatter PD assembly, and check if there is a ring in the focal facula,
shown as follows:

Flow cell
interior wall
needs
cleaning
(exterior wall
also needs
cleaning in this
example)

Figure 7-9 Brightened dot on the interior wall of the flow cell

The focal facula


before the side
scatter PD
assembly with
an optical ring

Figure 7-10 The optical ring before the side scatter PD assembly

 Troubleshooting: click Menu>Service>Maintenance, and then select "Probe Cleanser


Soak" to perform automatic soaking and maintenance to the flow cell. If the optical ring in
the focal facula before the side scatter PD assembly still exists, manual probe cleanser is
needed to be performed as instructed below:
1. Take out 2 clean S-50 tubes or 3350 silicone tubes (length: about 10cm). Connect
one tube to the newly unpacked syringe, and the other one to the waste outlet
connector of the flow cell. Snip the plastic cable tie using a pair of diagonal pliers, and
then remove the flow cell tray using a screwdriver. Unplug the sheath fluid inlet tube,
and plug the tube which is connected to the syringe;
2. Draw the diluent from the flow cell assembly with the syringe, and then put the other
end of the tube connecting to the waste outlet into a small beaker. Inject a certain
volume of probe cleanser with the syringe, and make sure it is visible that the probe

7-7
Optical System

cleanser is flowing into the flow cell.

Figure 7-11 Manual probe cleanser maintenance

3. After the flow cell is fully filled with probe cleanser, wait 10-15 minutes. Slightly draw
the fluid with the syringe, and check if the brightened dot on the interior wall
disappears;
4. If the dot disappears, draw out the probe cleanser out of the flow cell assembly, and
then reset the tubing. In the PC software, click
Menu>Service>Maintenance>Clean>Flow cell to perform the flow cell cleaning until
the "DIFF Particles Total" of the background count "Special Info." becomes less than
50 (place the cursor on the background count result of the "Review" screen, and then
right-click the mouse to show the "Special Info.");
5. If the brightened dot still exist after manual cleaning, the optical system needs to be
replaced. See the next section for details.
 Note:
1. Generally speaking, if the scattergram distribution is similar to Figure 7 or it is judged that
the flow cell interior wall needs cleaning, perform automatic maintenance of the flow cell
first, and do not remove the cover for check until the automatic maintenance fails or does
not take effect;
2. Avoid direct eye contact with the laser beam; wear proper personal protective equipment
during manual cleaning, and wear the PVC gloves properly; do not drop the probe
cleanser on the instrument or on the clothes/skin of any people.
 Flow cell clog
 Error presentation: when flow cell clog occurs, the valve pressure ascends, and the "Flow
cell clog" error is reported by the instrument.
 Error confirmation: the error report of the instrument;
 Troubleshooting: click the "Remove Error" button to see if the error can be removed. If yes,
check if the fluid in the flow cell can flow out from the waste outlet smoothly while pulling
and pushing the syringe (as instructed by the manual maintenance procedure); If not,
replace the optical system as instructed by the next section.

7-8
Optical System

7.5.2. Replacing the Optical System


If there is component damage or maintenance failure, optical system replacement is needed.
Do as follows:
1) Perform the shutdown procedure, and then power off the analyzer;
2) Remove the top cover and right door of the analyzer;

Figure 7-12 Removal of the top cover and the right door

3) Snip the plastic cable tie fixing the flow cell tray with a pair of diagonal pliers, and then
unscrew the 2 M3x8 cross-recessed panhead screws (with washers) fixing the flow cell
tray with a cross-headed screwdriver to remove the tray;
4) Wear a pair of disposal PVC gloves, and then remove the T connector of the commutation
assembly and the tubing of SV18 valve in turn (marked by the arrows in the figure below).
If there is any fluid leakage, wipe it with tissue or wet cloth immediately to avoid corrosion
to the instrument;

Figure 7-13 Removing the flow cell tray and tubing of the T connector

7-9
Optical System

5) Get a clean S-50 tube or 3350 silicone tube of about 10cm, and connect one end to the
sheath fluid inlet, and the other end to the sample inlet. Connect the tube that is removed
from the SV18 valve to the sample outlet (marked by red arrows in the figure);
6) Disconnect the optical system signal transmission cable and control wire from the data
board;
7) Unscrew the 6 inner hexagon screws fixing the optical system shielding cover with a
screwdriver, and then remove the 4 M4x8 cross-recessed panhead screws (with washers)
from the base plate;

Figure 7-14 Screws on the base plate

8) Remove the whole optical system from the instrument, and install the shielding cover back
to the removed system, and put them into the packing box;
9) Install the new optical system based on the reversed procedure above.

7.6. Optical System Gain Calibration


Optical system gain calibration is necessary when the maintenance or replacement of the
optical system finishes, the analyzer is left unused for a long time, the ambient environment is
changed, and the analyzer has experienced a long-distance transportation, in order to make
sure the optical system can work properly. The calibration should be performed as instructed
below:
1)Select the venous whole blood mode (open-vial) for sample analysis, and run the BC-5D
control. After the analysis is completed, select the analysis data in the "Review" screen, and
then click the "Optical" button on top right to go to the optical adjustment screen.
2)Select "Control Mode" and click "Calculate" as shown in Figure 15. The "FS Gravity Center
Position" of particle 2 should fall in ±1.94 of the BC-5D control target, and the "SS Gravity

7-10
Optical System

Center Position" should fall in ±2.6 of the BC-5D control target. If one or both of the values are
out of range, perform the next step of gain calibration.

Figure 7-15 Optical adjustment screen of control

3)Enter the FS and SS gravity center targets of the BC-5D control into the "Particle 2 Peak
target" fields, and then the analyzer automatically calculate the gain values needed, which are
displayed in the "Gain" column. Click the "Gain Setup" button, and the FS and SS gain will be
updated to the new gain values.
4)Run the BC-5D control again, and go to the "Optical" adjustment screen. Perform Step 2 to
confirm. If the values are still out of range, repeat Step 1-3 until they fall in the respective
range.

7-11
8 Hardware System

8.1. Overview
This chapter introduces functions of the hardware system and its interfaces. The hardware
system includes data flow, user interface, control flow, power system, structure and
connections by logic.
Hardware System
Optical Product
detection application
principle interlink
Counting bath
Impedance Signal sorting
Laser tube
detection Signal collection Direct user Network cable
HGB sensor
principle Digital processing input
Photocell
Main control Key switch
Colorimetry
detection embedded
system Direct user Indicator
principle
Data stream design platform output Buzzer

Barcode
External scanner
interfaces

Motor Structure
Moving
Electromagne
mechanism and interlink User interaction design
t
drive and design
Valve detection
Pump Fluid
Float switch component
drive and
Heater detection
Fan Thermal Auxiliary
component control Power
Temperature drive and platform monitor
sensor detection
Pressure Power switch
sensor System status Grid power
monitor
Power Grid power
Barcode input
Fluid conversion
scanner
detection
Photocouplers Control stream design Power system design

Figure 8-1 The logical diagram of hardware system

8.2. Diagram of Hardware System

J81 Indicator
J78
Electrimagnetic J2/J3- Digital board/key board
valve P12V J13 control J8
Waste pump J4- Network patching
P12V board J1
board
D5V J11 Optical/right door
Fluid detection J7-D5V
J85/86/77 J79
board micro-switch
Temperature FS/SS
Power drive

J15 P24V
sensor and J8 preamplification
Diluent/waste board
wires
board

sensor- +- LaserHGB
control board
float&switch
Sample J9
PowerA12V Analog assembly
collection board WBC bath
assembly/relieve J10 AC120 board
valve V RBC bath
Syringe
photocoupler Pressure sensor
J11
photocouple J6 D5V/
r P12V
Fan J5-12V P12V/2
4V(
D5V
Diff/laser J14-
heater P24V
Sample
J16-J19
collection
assembly/syring
e motor

Figure 8-2 Diagram of haredware system

8-1
Hardware System

8.3. Analog Board


8.3.1. Overview
The analog board drives sensors, amplifies, filters and sorts primary signals of the sensors
into signals that meets A/D input requirement. Besides, the analog board supplies power to
all analog boards. Functional diagram of the analog board is as follows:

RBC/PLT RBC/PLT signal RBC/PLT


sensor adjusting RBC/PLT HOLE
Constant current
RBC/PLT aperture constant
source and
current source module and
zapping control module zapping control

WBC WBC signal WBC


sensor adjusting WBC HOLE
Zapping
WBC aperture constant
current source and zapping control
HGB control

HGB HGB signal Gain control Connector


sensor adjusting HGB to digital
Drive Drive control
HGB luminotron control buffer board
constant current drive modul
A±12V( e
Monitor signal
AC120V Analog power
Power adjusting
A±12V adjusting module
module
SS
preamplificati SS adjusting SS
on board channel
FS FS adjusting FS
preamplificati channel FS DC
on board background
Switch control signal
Laser
control Laser tube drive current monitor signal
board

Figure 8-3 Functional diagram of the analog board

8.3.2. Function
The analog board can be divided into 7 modules: analog power adjusting module,
voltage monitoring module, HGB channel module, impedance channel module, optical
channel module, drive buffering module, and pressure monitoring module.
Analog power adjusting module:
 This module filters the A±12V voltage and transforms it into the 5V/-5V analog
voltage required by the analog section; meanwhile it doubling rectifies the A+12V
voltage, and stabilizes it into 56V direct current.
Voltage monitoring module:
 This module converts level of the voltages to be monitored on the board to the level
that can be received by AD (0~5V), and makes the impedance fulfill requirement of

8-2
Hardware System

AD conversion.
 The monitored signals include: WBC/RBC aperture voltage, +/-12V, 56V zapping
power and FS direct current background.
HGB channel module:
 This module drives HGB sensor, amplifies and adjusts HGB signals.
Impedance channel module:
 This module drives the RBC/PLT and WBC sensors, amplifies and adjusts RBC/PLT
and WBC impedance signals. Besides, it provides counting bath zapping function.
Optical channel module:
 This module amplifies and adjusts FS/SS and SF signals input from the
preamplification board.
Pressure monitoring module:
 This module drives the pressure sensor, coverts pressure/vacuum change into
voltage change, and amplifies the voltage.
Drive buffering module:
 This module converts TTL control signals input from external boards into actuating
signals with certain driving capability.

8.3.3. Structure
The PCBA structure of the analog board is as follows.

Table 8-1 Modules of the analog board

Module No. Description


P1 Impedance channel module
P2 Pressure monitoring module
P3 Analog power adjusting module
P4 HGB channel module
P5 Voltage monitoring module
P6 Optical channel module
P7 Drive buffering module

8-3
Hardware System

P3

P6

P4

P5 P7
P2
P1

Figure 8-4 PCBA structure of the analog board (top)

8.3.4. Interfaces
 Interface layout and description

8-4
Hardware System

J2 J4 J3 J6
J5
4

J
HGB 8
drive
and Optical signal
Power adjusting amplifi amplification
module cation
J
9

Control
Monitor signal adjusting signal drive
circuit circuit

Shielding
region

Air pressure J1 Constant


Impedance
adjusting current Impedance J
preamplific
circuit source amplification 7
ation
circuit circuit

J2

Figure 8-5 Analog board sockets

Table 8-2 Analog board interfaces

Position No. Function


J1 Interface of the analog board and RBC/PLT sensor
J2 Interface of the analog board and WBC sensor
J3 Analog signal interface of the analog board and
optical preamplification board
J4 Interface of the analog board and HGB sensor
J5 Interface of analog power
J24 Interface of zapping power
J6 Interface of the analog board and laser control board
J7 High speed analog signal interface of the analog
board and digital control board
J8 Low speed analog signal interface of the analog
board and digital control board
J9 Digital signal interface of the analog board and digital
control board

8-5
Hardware System

8.3.5. Indicators and test points


The functions of the indicators are listed in the following table.

Table 8-3 Functions of the indicators in the analog board

Indicator Function
D47 Indicator of analog +12V, normal status: on
D48 Indicator of analog -12V, normal status: on
D49 Indicator of analog +5V, normal status: on
D50 Indicator of analog -5V, normal status: on

The functions of main test points in the board are listed in the following table.

Table 8-4 Test points in the analog board

Test
Printed label Function Note
point
TP16 2.5V Reference voltage in the Normal voltage range:
pressure monitoring circuit 2.4V~2.6V
TP17 2.5V Reference voltage in the Normal voltage range:
pressure monitoring circuit 2.4V~2.6V
TP18 1.25V Reference voltage in the Normal voltage range:
pressure monitoring circuit 1.2V~1.3V
TP19 2.5V Reference voltage in the Normal voltage range:
pressure monitoring circuit 2.4V~2.6V
TP22 12V Test point of 12V power Normal voltage range:
11.4V~12.6V
TP26 N12V Test point of -12V power Normal voltage range:
-11.4V~-12.6V
TP23 5V Test point of 5V power Normal voltage range:
4.75V~5.25V
TP27 N5V Test point of -5V power Normal voltage range:
-4.75V~-5.25V
TP1 56V Voltage test point of Normal voltage range:
impedance channel 47V~60V
constant-current source
TP48 VCONST_MON 56V monitoring voltage Normal voltage range:
1.8V~2.2V
TP44 12VM 12V monitoring voltage Normal voltage range:
2.2V~2.6V
TP47 N12VM -12V monitoring voltage Normal voltage range:
1.2V~1.5V
Output signal of HGB
TP37 HGB
channel
TP2 RBC Output signal of RBC

8-6
Hardware System

Test
Printed label Function Note
point
channel
Output signal of WBC
TP9 WBC
channel
Vacuum monitoring output
TP20 NP
signal
Pressure monitoring output
TP21 PP
signal
TP49 FS Output signal of FS channel
TP61 SS Output signal of SS channel

8.3.6. Troubleshooting
Table 8-5 lists the frequent errors and solutions of the analog board to guide the
troubleshooting actions. The error here refers to hardware error only, the same error situation
caused by the fluidic, optical, reagent or software systems (for which you can refer to the
related chapters for solution) are excluded.
Before troubleshooting analog board errors, the following checks shall be performed.
1. Check if the power output is normal;
2. Check if the wires are firmly connected to the analog board; if the wire No. and socket No.
match; and if the wires are damaged.
3. Check if the power input of the board is normal; and check if the indicators are normal
according to Table 8-4.
4. Restart the analyzer to see if the error is removed.
If all the above actions are done, and the error still exists, you may go on to troubleshoot the
error as instructed in the following table.

WARNING
 Be sure to wear antistatic gloves when assembling and disassembling the
board, and always hold on the edge of board.

 When using multimeter or other equipments to test a component, make sure


not to touch other components or wires to avoid board damage caused by
short circuit.

Table 8-5 Errors and troubleshooting list of the analog board

Error
No. Cause Error Diagnosis
Consequence
"+12V analog The following situations can all be diagnosed
voltage as analog error:
1 Circuit error
abnormal" is  D47 indicator turns off
reported  The voltage of test point TP22 (12V) is

8-7
Hardware System

Error
No. Cause Error Diagnosis
Consequence

outside 11.4~12.6V

 The voltage of test point TP44 (12VM) is


outside 2.2V~2.6V
The following situations can all be diagnosed
as analog error:
"-12V analog  D48 indicator turns off
voltage  The voltage of test point TP26 (N12V) is
2 Circuit error
abnormal" is
outside -11.4~-12.6V
reported
 The voltage of test point TP47 (N12VM) is
outside 1.2V~1.5V
The following situations can all be diagnosed
as luminotron error:
 The luminotron is off, the level of
TP72(HGBLED_N) is low (about 0V)
 The luminotron is on, the HGB voltage can
HGB luminotron be adjustable along with the gain, but when the
3
error gain is adjusted to its upper limit, the HGB
voltage is still lower than 3.2V. The situation
suggests the aging of the luminotron (when
fluidic problems are excluded)
 The error is removed after replacing the
HGB assembly
The following situations can all be diagnosed
"HGB Blank
as analog board drive circuit error:
Voltage
 The luminotron is off, and the
abnormal" is
TP31(HGB_ON_N) is of high level (3.3V) when
reported HGB luminotron
4 running analysis sequence
drive circuit error
 After replacing the HGB assembly, the
luminotron is still off
 The HGB luminotron is off even after it has
been replaced
HGB
photoelectric cell
HGB voltage is 0; the voltage of test point
error (usually the
TP38 (HGB1) is positive and greater than
5 anode and
0.6V. The error is removed after replacing
cathode are
HGB assembly.
incorrectly
connected)
6 HGB circuit error The following situations can all be diagnosed

8-8
Hardware System

Error
No. Cause Error Diagnosis
Consequence
as circuit error:
 HGB voltage is higher than 4.8V when the
gain is at its minimum
 The voltage of test point TP37 (HGB) is
3.2~4.8V, but the HGB voltage displayed on the
screen is not within the range
 HGB voltage is lower than 3.2V when the
gain is at its maximum, and replacing the HGB
bath fails to solve the problem
 D49 (+5V) indicator is off
 The voltage of test point TP40

(VCONST_HGB) is outside 2.4~2.9V

Error of the digital


HGB gain The gain changes from 50 to 200, but the HGB
7 potentiometer on
calibration fails tested is unchanged
the board
The following situations can all be diagnosed
as analog error:
 The voltage of 56V constant current source

is outside 47 ~ 60V, or the voltage of

Constant current TP48(VCONST_MON) is outside 1.8~2.2V


"Aperture source
 The voltage difference between pin 2 and
voltage error/monitoring
8 pin 3 of J1 is 12~18V when running RBC
abnormal" is circuit
analysis, but error is reported by the analyzer.
reported error//power
This situation suggests monitoring circuit error.
source error
 D49 (+5V) indicator is off
 Replace the counting bath with 20K resistor,
if the voltage tested by the two ends of the

resistor is outside 11.4 ~ 13.2V, that means

error occurs to the constant current source.


The following situations can all be diagnosed
as circuit error:
"Forward
 The scattergram is normal while "Forward
scatter blank
scatter blank voltage abnormal" is reported
9 voltage Circuit error
 D49 (+5V) indicator is off
abnormal" is
 The voltage of test point TP49(FS) is not
reported
1.5~1.9V when analysis is not running

8-9
Hardware System

Error
No. Cause Error Diagnosis
Consequence
Confirm as per the following procedure:
 Disconnect all wires connected to the
analog board and start up the analyzer, if the
error is removed, then short circuit of analog
board power source can be excluded; check
Auto power-off Short circuit of other wires and components connected to the
10
at startup power source analog board.
 Disconnect all wires connected to the
analog board and start up the analyzer, if the
error persists, then short circuit of analog board
power source can be concluded, and the
analog board should be replaced.

8.4. Digital Control Board (including CPU module)


8.4.1. Overview
The digital control board is consisted of the bottom plate and CPU module connected to each
other via socket, its structure is as follows:

Pinch plate
socket 2
60pin+60 AM1808 main Pinch
pin control module plate
socket 3
Signal
80pin
connecting
Analog board Pinaster main control board
line

Figure 8-6 Digital control board sockets

8.4.2. Function
Basic functions of the digital control circuit are:

1. Data processing: receiving data collected by the analog circuit, providing operation
system and software running platform for data processing,

2. System control: providing operation system and software running platform for
scheduling and monitoring of the analyzer operations.

3. User interacting: providing hardware platform for user interaction.

8-10
Hardware System

8.4.3. Structure

Optical system

Volumetric Power
J78 J79 J81 J8 board socket
socket(
Reserved analog Temperature
signal control
Fpga
configured control board Recorder J11) US US
J86 Pinaster main socket socket socket socket B-J B-J
control board Reserved FPGA Volumetric Key board
CAN port board socket socket
Valve control socket Analog board socket
USB-J
×2
J77
AM1808 CPU
60p module USB-J
socket
FPGA 80p ×2
Analog U2
socke
t
board Analog
ADC 7cm
circuit RJ45-J(J1)
RJ45 DDR2 60p
-J socket

RS232
RJ45 DB9
J85 DC/DC circuit
-J serial port
SD( ( J65
EEPRO
6cm J61 Mcircuit RTC
LCD back circuit
fpga-LCD display cpu-LCD display Touch
light screen
socket socket
socket port

Figure 8-7 Layout of the digital control board

8.4.4. Interfaces
Table 8-6 Hardware interfaces of the Pinaster main control board

No. Position Function


No.

1. J11 5V power input

2. J82 FPGA JTAG debug interface

3. J1 100M Ethernet interface

4. J78 Indicator and key board socket

5. J79 Door detection and aspirate key socket

6. J80 Volumetric board socket

7. J81 Drive board socket

8. J8 Autoloading board socket

9. J85 High speed analog signal socket

10. J86 Low speed analog signal socket

11. J77 Analog control signal socket

8-11
Hardware System

8.4.5. Indicators and test points


Power indicator

Board Position No. Function Description


CPU module D1 Power indicator If the indicator is on, the power
source is OK
Bottom plate D44 Power indicator If the indicator is on, the power
source is OK
Bottom plate D2 FPGA indicator If D2 flickers, FPGA is working
normally
Bottom plate D6 Network connection If the indicator is green, the
status indicator connection is OK; if it flickers, there
are data in transmission
Bottom plate D7 Network speed Yellow, on when the speed is
indicator 100Mbps, off when the speed is
10Mbps.
Test point

Board Position No. Function Description


CPU module TP1 Test point of 1.8V power Normal voltage range: 1.8V~±5%
CPU module TP2 Test point of 3.3V power Normal voltage range: 3.3V~±5%
CPU module TP3 Test point of 1.3V power Normal voltage range: 1.3V~±5%
Bottom plate TP1 Test point of 1.8V power Normal voltage range: 1.8V~±5%
Bottom plate TP2 Test point of 3.3V power Normal voltage range: 3.3V~±5%
Bottom plate TP3 Test point of 1.2V power Normal voltage range: 1.2V~±5%
Bottom plate TP36 Test point of 5V power Normal voltage range: 5V~±5%
Bottom plate TP39-43 GND Normal voltage range: 0V~±5%

8.4.6. Troubleshooting
Table 8-7 Errors and troubleshooting list of the digital control board

Error
No. Cause Error Diagnosis
Consequence
Confirm as per the following procedure:
1. Disconnect all wires connected to the digital control
board and start up the analyzer, if the error is
removed, then short circuit of digital control board
Short
power source can be excluded; check other wires
Auto power-off circuit of
1 and components connected to the digital control
at startup power
board.
source
2. Disconnect all wires connected to the digital control
board and start up the analyzer, if the error persists,
then short circuit of digital control board power
source can be concluded, and the digital control

8-12
Hardware System

Error
No. Cause Error Diagnosis
Consequence
board should be replaced.
The network Confirm as per the following procedure:
cannot be 1. Replace the PC to see if the error is removed
Hardwar
2 connected 2. Observe indicator D6 to see if it is off
e error
with upper 3. Check if the network cable is properly connected
device 4. Replace the board to see if the error is removed
Confirm as per the following procedure:
1. Observe the FPGA indicator D2, if it does not flicker,
Fail to collect FPGA
3 then the FPGA is not working normally.
analog data error
2. Check the connection wire to the analog board.
3. Check if the analog board is OK.

8.5. Drive Board


8.5.1. Overview
The drive board is an auxiliary control board, its control commands come from upper
modules, such as digital control board. The drive board analyzes control commands from
upper modules and transmits them into bottom layer control signals to realize drive
control of the moving parts (sample collection assembly, syringe assembly), heat
engineering parts (heater) and fluidic parts (valves, pumps); it gathers temperature and
position information of the analyzer or its components via the sensors, and sends some
or all of the information to the upper modules as necessary. Its functional diagram is as
follows:

8-13
Hardware System

Upper
control
system

Command and
data transmission
Thermal
Moving parts
parts drive
drive and Step motor
and
detection
detection
Heater

Valve
Pump

Control Sensor
platform (pressure, temperature,
etc)

Photocoupler
Float
Switch
System
Fluid parts
status Others
drive
monitor

Drive board Peripherals


Figure 8-8 Functional diagram of power drive board

8.5.2. Function
The functions of power drive board are:
1. Main control module: this module is consisted of the ARM+FPGA structure, it analyzers
upper layer commands, drives the execution parts, collects and sends reference data of the
sensors to the digital control board, so that it may control the power of the analyzer effectively.
2. Driving motor: it drives the sample collection mechanism and the syringe assembly via the
drive motor.
3. Moving mechanism detection (photocoupler detection): detects mechanism position via
sensors.
4. Driving valves and pumps: it drives valves and pumps so that samples or reagents may flow
in the fluidic system.
5. Driving heater: it forms a closed-loop control system with the temperature sensor to provide
proper temperature for operation of the components or reaction of the reagents.
6. Driving the fan: it drives the fan to eliminate heat.
7. Temperature detection: it detects the temperature of components, reagents and the
environment via temperature sensors.
8. Pressure detection: it detects output pressure of the pressure sensor to control pressure
generation of the gas system and monitor the pressure.

8-14
Hardware System

9. Fluid detection: it detects the electrical level signal of the fluid detection board to monitor if
there is any reagent.
10. Float switch detection: it detects the on/off status of the float switch to monitor the
full/empty status of waste container and diluent container.
11. Voltage detection: monitors the voltage of the board itself.
12. Parameter storage: it stores all types of calibration parameters so that necessary
information can be saved when power-fail occurs.
13. Power module: it realizes the conversion from 12V to 5V or 3.3V.

8.5.3. Structure
See Table 8-8 and Figure 8-8 for the modules of power drive board.

Table 8-8 Modules of power drive board

No. Module

P1 Motor drive module

P2 Heater drive module

P3 Moving mechanism detection (photocoupler detection) module

P4 Float switch detection module

P5 Temperature detection module

P6 Power module: (A: 5V and 12V; B: 3.3V)

P7 Fluid detection module

P8 Fan drive module

P9 Valve drive module

P10 Voltage detection module: (A: 12V detection; B: 24V detection)

P11 Pump drive module

P12 Parameter storage module

P13 Main control module

8-15
Hardware System

P P P P P
6-A 5 4 3 2

P
7
P
8
P P
9 1
P
10-A
P
11
P P P P
12 13 6-B 10-B
Figure 8-9 Modules of power drive board

8.5.4. Interfaces
Table 8-9 Interfaces of power drive board

Position
Interface
No.
J2
Valve drive interface
J3

J4 Pump drive interface

J6 D5V and P12V power input interface

J7 Fluid detection board interface

J8 Analog signal interface

J9 On/off detection interface

J10
Photocoupler detection interface
J11

J13 Interface to data board

J14 Heating drive interface

J15 P24V power input interface

J16

J17
Motor drive interface
J18

J19

8-16
Hardware System

8.5.5. Indicators and test points


See Table 8-10 and 8-11 for indicators and test points of the power drive board.

Table 8-10 Indicators of power drive board

Function Module LED_1 LED_2 Function

Sample collection
assembly X direction D51 D61
motor LED_1: flickers when
Sample collection there is motor pulse
assembly Y direction D52 D62 output; off when no pulse
motor output.
ASP motor D53 D63 LED_2: on when the
Motor indicator
residual step of motors is
SP motor D54 D64 not zero, which means the
motors are still working;
SH motor D55 D65
off when the actions are
DIL motor D56 D66 done.

LYSE motor D57 D67

P24V_LED D98 /

P12V_LED D97 / The LED is on when the


Power indicator power channel works
VCC_LED(5V) D96 / normally, and vice versa.

VDD_LED(3.3V) D99 /

HT1 D81 /
When the heating drive is
Heating drive
HT2 D82 / working, the LED is on;
indicator
and vice versa.
HT3 D83 /

When FPGA is running


FPGA indicator FPGA_LED D94 / normally, the indicator
flickers; and vice versa.

D88: when photocoupler


/ D87 / status changes, the
indicator flickers and then
Photocoupler turns off;
indicator D87: when photocoupler
/ D88 / status changes, the
indicator shows the last
photocoupler status. Off

8-17
Hardware System

Function Module LED_1 LED_2 Function

when being blocked; on


when not blocked.

When MCU is running


MCU indicator MCU_LED D91 / normally, the indicator
flickers; and vice versa.

When the fluid detection


board and MCU board are
Fluid detection
LIQ D95 / not properly connected,
board indicator
the indicator turns on; and
vice versa.

Test point
Power drive board has a complicated circuit, so there are many test points. Here we only list
some critical test points.

Table 8-11 Critical test points of power drive board

Test point Printed label Function Note

TP1 VCC 5V test point Normal voltage range 4.75V-5.25V

TP2 GND Ground test point Normal voltage range: 0V-0.2V

TP3 VDD 3.3V test point Normal voltage range: 3.2V-3.4V

TP4 GND Ground test point Normal voltage range: 0V-0.2V

TP5 1V2 1.2V test point Normal voltage range: 1.1V-1.3V

TP27 GND Ground test point Normal voltage range: 0V-0.2V

TP6 2V5 2.5V test point Normal voltage range: 2.4V~2.6V

TP37 GND Ground test point Normal voltage range: 0V-0.2V

TP7 P12V 12V test point Normal voltage range: 10.8V-13.2V

TP8 GND Ground test point Normal voltage range: 0V-0.2V

TP9 P24V 24V test point Normal voltage range: 21.6V-26.4V

TP10 GND Ground test point Normal voltage range: 0V-0.2V

8-18
Hardware System

8.5.6. Troubleshooting
This chapter introduces the troubleshooting process of the drive board based on its modules
and structure. The following preparations must be done before troubleshooting.
1.Check if the power supply of the analyzer is OK.
2.Check if the peripheral parts (motors, valves, and pumps), sensors (photocouplers,
temperature sensors), wires and other accessories related to the drive board are OK.
3.Check if the wires are firmly connected to the ports.
4.Restart the analyzer to see if the error is removed.
If the cause of the error still cannot be located, continue with error troubleshooting as
instructed in the following table.

Table 8-12 Troubleshooting Method of the power drive board

No. Error Type Cause Error Diagnosis Note

The following situations can be


Before
concluded as power drive board
troubleshooting errors
errors:
of other power
1. Indicator D97 turns off;
12V power Circuit modules that are
1 2. Voltage of TP7 is outside
error error related to the drive
11.4V-12.6V;
board, be sure to
3. Electrical components
check if the power
connected to 12V power module
supply is OK.
are burnt out.
The following situations can be The troubleshooting
concluded as drive board errors: method above can be
1. When executing motor used for modules with
Error of the
running command, indicators indicators, like the
sample
D51 and D61 turn off. main control module,
collection Circuit
2 2. Components of the drive heating module,
assembly X error
circuit are burnt out. photocoupler
direction
3. The components are not burnt detection module,
motor
out, but after replacing motor motor module and
and wire, the motor still fails to fluid detection
run as expected. module.
The troubleshooting
The following situations can be method above can be
concluded as drive board errors: used for modules
1. Components of the drive without indicators, like
Circuit circuit are burnt out. the float switch
3 Pump errors
error 2. The components are not burnt detection module, fan
out, but after replacing motor drive module,
and wire, the motor still fails to temperature detection
run as expected. module and pump
drive module.

8-19
Hardware System

8.6. Laser Control Board


8.6.1. Overview
The laser control board controls the laser so that it can emit stable laser with proper intensity.

8.6.2. Function
The functions of the laser control board are: power adjusting, laser drive current monitoring
and laser power control.
Power adjusting: this module filters the ±12V power from the analog board, the ripple after the
adjustment is lower than 100mV.
Laser drive current monitoring: measures the working current of laser, and sends the result to
analog board for monitoring.

Laser power control: laser control board controls the laser using constant power
control method, the photoelectric detector inside the laser monitors its output power
real-time, and the monitoring result forms a closed-loop system via negative feedback
to realize constant power output. The power is controlled by adjusting the
potentiometer VR1; it shall be within the range 3mW~5 mW.

Control
Laser constant power unit Laser
signal
(closed loop control unit) (HL6714G)

Laser drive Power


Monitor
current adjusting
voltage
monitoring (πfiltering)
module
A±12V Laser
control
board

Figure 8-10 Function diagram of laser control board

8.6.3. Structure
The PCBA structure of the laser control board is as follows.

Table 8-13 Modules of the laser control board

Module
Description
No.
P1 Power source adjustment
P2 Laser drive current monitoring
P3 Laser constant power control

8-20
Hardware System

P3 P2
P1

Figure 8-11 The PCBA structure of the laser control board (top)

8.6.4. Interfaces
The laser control board has two external interfaces, J1 to analog board and J2 to the
laser. See the following figure.

Figure 8-12 Interfaces of laser control board

8-21
Hardware System

Table 8-14 Definition of J1

PIN Definition Description I/O Level


1 AVSS -12V analog power I -12V

2 AGND Analog ground 0


3 LASER Laser drive current ≤5V



monitoring voltage

4 AVCC 12V analog power I 12V

5 #CONTROL Reference voltage I/O Low level: ≤0.8V


generation control signal High level: OC of 5V
6 VCC 5V digital power I 5V

Table 8-15 Definition of J2

No. Name Description I/O Level


1 LDA The anode of luminotron in O -

semiconductor laser

2 LDC The cathode of luminotron in I -

semiconductor laser

3 PDA The anode of receiver in I -

semiconductor laser

8.6.5. Indicators and test points


The laser control board does not have an indicator, as it may interfere the measurement of
the preamplification board. See the following table for the test points.

Table 8-16 Test point of the laser control board

No. Test point Tested signal Function


1 A+12V AVCC +12V power from the analog board
2 A-12V AVSS -12V power from the analog board
5V power from the analog board, turns on
3 D5V VCC
photocouplers on board
4 AGND Analog ground \
2.5V reference voltage generated by U1 on
5 TPVREF VREF
the board
2 times the ground voltage of the sliding end
of varistor (VR1), which control the intensity
6 TP2VREF 2VREF
of the laser. The higher the voltage is, the
higher the laser light intensity, and versa.

8-22
Hardware System

No. Test point Tested signal Function


Pressure loss of the current signal returned
7 TPIPD PDA by the photoelectric receiver in the
semiconductor laser on R1, R21 or R1//R21.
Signal of the working current of luminotron in
the semiconductor laser; the voltage of
8 TPILD LASER TPILD reflects the working current of
luminotron, which checks if the laser is
working as expected.

8.6.6. Troubleshooting
See the following table to troubleshoot errors of the laser control board:

Table 8-17 Troubleshooting errors of the laser control board

No. Error Name Criterion Cause Troubleshooting


The connection with Reconnect or replace the
the analog board is wire.
loose, or the wire is
damaged.
The voltage of
The power supplied Check if the power
test point
to laser control board supplied by the analog
+12V power A+12V is
1 is incorrect board is correct.
error outside the
The power control Check the circuits of the
range
circuit is not working board.
12V±0.6V
properly, like short
circuit to the ground,
so the power is
lowered or lifted.
The voltage of
test point
The cause is the
-12V power A-12V is
2 same as that of the Same as above
error outside the
+12V error.
range
-12V±0.6V
The connection with Reconnect or replace the
the analog board is wire.
The voltage of
loose, or the wire is
test point D5V
5V power damaged.
3 is outside the
error The power supplied Check if the power
range
to laser control board supplied by the analog
5V±0.25V
by the analog board board is correct.
is incorrect

8-23
Hardware System

No. Error Name Criterion Cause Troubleshooting


The voltage of The connection with Reconnect or replace the
signal the analog board is wire.
#CONTROL loose, or the wire is
Control signal under normal damaged.
4
error working Check if the signal sent by
The control signal
condition is no the analog board is
sent by the analog
higher than correct.
board is incorrect
0.8V.
Voltage of Reweld or replace U1.
If the -12V power is
TPVREF is
normal, the error may
Reference not 2.5V±0.1V
5 be caused by dry
voltage error (-12V is taken
joint or damage of
as the ground
U1.
reference)
The voltage of If TPVREF is normal, Reweld or replace the
TP2VREF is the error may be components.
Laser
not at the caused by dry joint or
intensity
normal damage of varistor
6 control
working value VR1, or improper
reference
(the voltage welding of U2 and the
voltage error
shall be R C components
4V~4.1V) around.
Laser tube damage Reconnect or replace the
or connection error wire, or replace the laser
The voltage of (the connection is tube.
Output error TPILD is not loose or the wire is
of laser within the damaged).
7 intensity range 1.0~3V 5V voltage error See error 3
monitoring (under current Control signal error or SEe error 4, and check
signal TPILD adjustment control circuit error the subsequent circuit.
conditions) Dry joint or damage Reweld or replace U3 and
of U3 and the the components around.
components around

8-24
Hardware System

8.7. Preamplification Board


8.7.1. Overview
The preamplification board performs photoelectric conversion and signal amplification of
the two scatters (FS--forward scatter, also called low angle scatter; SS--side scatter, also
called high angle scatter) from the flow cell. The low angle and high angle amplification
boards share 1 PCB, the amplification times is obtained by welding resistors.
8.7.2. Function
The functions of the preamplification board are: power adjustment, photoelectric conversion
and signal adjustment.
Power adjusting: this module filters the ±12V power from the analog board, the ripple after the
adjustment is lower than 50mV.
Photoelectric conversion: the photoelectric conversion unit converts optical signal to current
signal using photodiode.
Signal adjusting: converts current signal to voltage signal via I/V, and then sends the signal to
the amplification and adjustment unit to process it into signal that meets the input requirement
of the analog board.

Data
Signal adjusting unit
board

Photoelectric Power
FS( SS adjusting
conversion
(π filtering)
FS/SS
A±12V
preamplification
board

Figure 8-13 Functional diagram of the FS/SS preamplification board

8.7.3. Structure
The PCBA structure of the preamplification board is as follows.

Table 8-18 Modules of the preamplification board

Module No. Description


P1 Power source adjustment
P2 Photoelectric conversion
P3 Signal adjustment

8-25
Hardware System

P1

P2
P3

(a) (b)

Figure 8-14 PCBA structure of the preamplification board (a) top (b) bottom

8.7.4. Interfaces
The FS/SS preamplification board has 1 external interface, which is J1 to the motherboard.
The layout of the board is as follows:

Figure 8-15 Interface layout of the FS/SS preamplification board

8-26
Hardware System

8-19 Definition of J1

PIN Definition Description I/O Level


1 AGND Analog ground 0

2 FS/SS Preamplification board < 1V


output voltage signal

3 SHELL Shielding ground - 0

4 AVSS A-12V analog power I -12V±5%

5 AGND Analog ground 0


6 AVCC A+12V analog power I 12V±5%

8.7.5. Indicators and test points


The preamplification board does not have an indicator, as it may interfere its measurement.
See the following table for the test points.

Table 8-20 Definition of test points on the preamplification board

Test
No. Tested signal Function
point
1 AGND Analog ground \
2 +12V AVCC +12V power from the analog board
3 -12V AVSS -12V power from the analog board
4 OUT OUT Output signal of FS/SS preamplification board

8.7.6. Troubleshooting
See the following table to troubleshoot errors of the preamplification board:

Table 8-21 Troubleshooting errors of the preamplification board

Error
No. Criterion Cause Troubleshooting
Name
The voltage of The connection with the
Reconnect or replace
test point +12V is analog board is loose, or the
the wire.
12V outside the range wire is damaged.
1 power 12V±0.6V, or the Check if the power
error ripple noise is The 12V power sent by the supplied by the
higher than analog board is incorrect. analog board is
50mV. correct.

8-27
Hardware System

Error
No. Criterion Cause Troubleshooting
Name
Dry joint or damage of the
components related to test
Reweld or replace the
point +12V (such as inductor
components.
L1, capacitor C24, C27, C20
and C23).
The connection with the
Reconnect or replace
analog board is loose, or the
the wire.
wire is damaged.
The voltage of
Check if the power
test point -12V is
The -12V power sent by the supplied by the
-12V outside the range
analog board is incorrect. analog board is
2 power -12V±0.6V, or the
correct.
error ripple noise is
Dry joint or damage of the
higher than
components related to test
50mV. Reweld or replace the
point -12V (such as inductor
components.
L2, capacitor C22, C26, C25
and C21).
SS output signal The FS board is installed to
too weak the position of the SS board Replace the boards.
(assuming it is by mistake.
caused by circuit Incorrect resistance, dry joint Reweld or replace the
problem) or damage of R4, R5 or R6. components.

FS output signal The SS board is installed to


too strong the position of the FS board Replace the boards.
(assuming it is by mistake.
caused by circuit Incorrect resistance, dry joint Reweld or replace the
Output problem) or damage of R4, R5 or R6. components.
3
error No output signal
Dry joint or damage of Reweld or replace the
of the
photodiode D1 or R1. components.
preamplification
board (FF/SS), or
Dry joint or damage of U2 or Reweld or replace the
the signal is too
U3. components.
weak.
Check the related resistors
Bandwidth error
and capacitors, such as R4,
of the Reweld or replace the
R5, R6, C1, C5 and C4, to
preamplification components.
see if there is any dry joint or
board (FS/SS)
damage.

8-28
Hardware System

8.8. Power Board


8.8.1. Overview
The power board of BC-5300/BC-5100 Auto Hematology Analyzer provides six groups of
stable power, including D5V, A+12V, A-12V, AC130V, P12V and P24V.

EMI circuit 90( 390V


AC PFC D5V
and rectifier Standby circuit
input circuit
circuit
VCC

Linear
390V circuit Flyback Forward
protectiv protectiv
VDD e circuit e circuit

A+12V
A-12V
Flyback circuit
AC130V

P12V
Forward circuit
P24V

Figure 8-16 Functional diagram of the power board

8.8.2. Function
The power board works under the voltage of (50~60Hz) input by AC 90V~264V.
Once the power switch is on, all circuits start to work, the D5V, A+12V, A-12V, AC130V, P12V
and P24V all have voltage output.

See the following table for details:

Table 8-22 Characteristics of output voltages

Voltage Load
Minimum Rated Output voltage
Voltage adjustment adjustment Sound
current current range
rate rate
D5V 2A 5A 4.85/5.25V ±5% 100mV
±1%

+A12V 0mA 1A 11. 5/12. 5V ±1% ±5% 100mV


-A12V 0mA 650mA -11.5/-12.5V ±5% 100mV
±1%

8-29
Hardware System

Voltage Load
Minimum Rated Output voltage
Voltage adjustment adjustment Sound
current current range
rate rate
P12V 0.3A 5.5A 11.5/12.5V ±5% 150mV
±1%

P24V 0A 4A 22/27V ±10% 150mV


±1%

AC120V 0mA 60mA 115/145V(RMS) ±1% ±10% /

The highest current generated by the P24V power is 7.8A, whose duration is 2S, cycle is 60S.

8-30
Hardware System

8.8.3. Structure

Figure 8-17 Power board

8-31
Hardware System

8.8.4. Interfaces
The power board has 7 external interfaces, 2 of them are sockets (J1 and J2), and the others

are connected to external components with wires (the PCB numbers are TP1~TP20). See the

following figure for position of the interfaces.

Figure 8-18 Interfaces of power board

The functions of the interfaces are listed in the following table.

8-32
Hardware System

Welding
Interfaces Function Pin number Description
disk number
J1 AC input 3 / /
J2 Fan power output 6 / /
Analog section Output via wire
A-J12 power output 6 4 welded to PCB
Output via wire
A-J13 AC output part 3 2 welded to PCB
Power section power Output via wire
A-J35 output 10 10 welded to PCB
Digital section power Output via wire
A-J37 output 4 4 welded to PCB

Table 8-23 Interfaces of the power board

Definition of J1

Table 8-24 Input AC socket

Pin Definition
1 L, connect to the live wire of the grid power.
2 PG, connect to ground wire
3 N, connect to the null wire of the grid power.

Definition of J2:

Table 8-25 Fan socket

Pin Definition
P12V, connect to positive end of P12V output
1/3/5 voltage
PGND, connect to negative end of P12V output
2/4/6 voltage

Definition of pin A-J12

Table 8-26 Definition of analog board outputs

Welding disk Definition Pin


AGND, connect to the reference
ground of analog board output
TP16AGND\TP17AGND voltage 6,7
+A12V, connect to positive end of 5
TP15A12V +A12V output voltage

8-33
Hardware System

Welding disk Definition Pin


-A12V, connect to negative end of 8
TP18A-12V -A12V output voltage
/ NC 1/2/3/4

Definition of pin A-J13

Table 8-27 Definition of AC output

Weldi
ng disk Definition Pin
TP19\TP20 2 output ends of AC120 1/3
/ NC 2

Definition of pin A-J35

Table 8-28 Definition of power section power outputs

Welding disk Definition Pin


Positive end of P12V output
TP1P12V/TP2P12V 4/5
voltage
TP12PGND/TP13PGND/TP3P PGND, negative end of P12V
6/7/8/9/10
GND\TP4PGND\TP14PGND output voltage
TP9P24V\TP10P24V\TP11P24 Positive end of P24V output
1/2/3
V voltage

Definition of pin A-J37

Table 8-29 Definition of D5V outputs

Welding disk Definition Pin


Positive end of 5V output
TP5D5V/TP6D5V
voltage 1/2
DGND, negative end of 5V 3/4
TP7DGND/TP8DGND
output voltage

8.8.5. Indicators and test points


Table 8-30 Definition of debug and test points

No. Pin position Function Reference value


1 Q101.2 Q101 on/off waveform /
2 Q101.1 Q101 drive waveform /
3 C114.+ PFC output voltage 390±20V
4 U101.9 Chip reference voltage output 7.5V
5 U101.14 U101 oscillating waveform /
6 C206.+ VCC voltage 17V~22.5V

8-34
Hardware System

No. Pin position Function Reference value


7 C204 VDD voltage 12±1V
8 C223 Power supply voltage of U201 12±1V
9 Q201.1 Q201 drive waveform /
10 Q201.2 Q201 on/off waveform /
11 U201.8 U201 reference voltage 5V
12 U201.4 U201 oscillating waveform /
13 Q201.3 R235 voltage waveform, Q201 current /
waveform
14 C232.+ D5V output voltage and ripple voltage 5±0.5V
15 C311.+ U301 power supply voltage 12±1V
16 U301.4 U301 oscillating waveform /
17 U301.8 U301 reference voltage 8V
18 Q303.1 Q303 drive waveform /
19 Q303.2 Q303 on/off waveform /
20 Q303.3 Q303 current waveform, R313 voltage /
waveform
21 C326.+ 12VB voltage 12±0.5V
22 C328.+ 130V DC output 115V~150V
23 C332.+ A+12V output 12±0.5V
24 C338.- A-12V output -12±0.5V
25 U351.15 U351 power supply voltage 12±0.5V
26 U351.5 U351 oscillating waveform /
27 U351.11 U351 drive waveform /
28 U351.14 U351 drive waveform /
29 U351.16 U351 reference voltage 5V
30 Q361.1 Q361 drive waveform /
31 Q362.1 Q362 drive waveform /
32 Q363.1 Q363 drive waveform /
33 Q364.1 Q364 drive waveform /
34 U401 power supply voltage 12±1V
C409.+

35 U401.5 U401 oscillating waveform /


36 U401.14 U401 reference voltage 5V
37 U401.9 Q401 drive waveform /
38 Q406.1 Q406 drive waveform /
39 Q406.2 Q406 on/off waveform /
40 C423.+ P24V output voltage, ripple 22~27V
41 C442.+ P12V output voltage, ripple 12±0.5V

8-35
Hardware System

8.8.6. Troubleshooting
The errors of power board can be troubleshooted as per the following procedure.

Power error

Check the fuse N Are the D5V, VCC


and standby
outputs normal?
circuit

Check the PFC N Is the 390V output


circuit normal?

Is the VDD output N


Check the VDD linear circuit
normal?

A+12V/A-12V/AC130 abnormal
Are the A+12V/A- N indicates flyback converter error(
12V/AC130V( P12V/P24V
P12V/P24V abnormal indicates
normal?
forward converter error.

Other errors

Figure 8-19 Troubleshooting power board errors

It must be ensured that the power assembly and the main unit cabinet are firmly connected
by screws.

8-36
Hardware System

8.9. Fluid Detection Board


8.9.1. Overview
The fluid detection board detects if there is any reagent or diluent. The board gets power
supply from the drive board and sends its own signal to the drive board.

Fluidic tubes Fluid Power Drive


detection signal board
board

Figure 8-20 The connections of fluid detection board and other boards

8.9.2. Function
The functional diagram of fluid detection board is as follows:
Constant
current drive luminotron
Photoelectri Retarding OUT1
c receiver comparator
circuit

Constant
Switch of the current drive luminotron Photoelectri Retarding OUT2
Power constant circuit c receiver comparator

supply current drive


circuit
Constant
current drive luminotron Photoelectri Retarding OUT3
c receiver comparator
circuit

Constant
current drive luminotron Photoelectri Retarding OUT4
c receiver comparator
circuit
Fi
gure 8-21 Functional diagram of fluid detection board

8.9.3. Structure
The fluid detection board PCB:

Top

8-37
Hardware System

Bottom
Figure 8-22 Fluid detection board
8.9.4. Interfaces
Table 8-31 Interfaces of the fluid detection board to the motherboard

Pin Signal name I/O Description Level


1 DGND Ground 0V
2 D5V I Power supply +5V
3 LIQ1 O Fluid detection output signal, 0~+5V
4 LIQ2 high level 5V means there is
5 LIQ3 reagent detected; low level
6 LIQ4 0V means no reagent.
7 LIQ5
8 LIQ6
9 D_CTRL_N I Controls the on/off signals of Turn-off voltage:
photocoupler luminotron, high above 3.8V
level turns off the luminotron. Turn-on voltage:
below 2V
10 DGND Indicated the connection
status of fluid detection board

8.9.5. Indicators and test points


Table 8-32 Indicators of the fluid detection board

Position No. Color Description


D1~D4 Green On means there is no fluid in the photocoupler of the
luminotron.
Off means there is fluid in the photocoupler of the
luminotron.
D7 Red On means the fluid detection board is working,
D1~D4 can detect if there is fluid.
Off means the fluid detection board is in standby

8-38
Hardware System

Position No. Color Description


mode, D1~D4 cannot detect if there is fluid.

8.9.6. Troubleshooting
When error occurs to the fluid detection board, the analyzer will report "insufficient reagent".
Troubleshoot the fluid detection board error as per the following procedure:

The error “insufficient reagent” is reported

Is the voltage between


J1.2 and J1.10 about 5V?
NO NO
Is D7(red) in the fluid detection board
on when the analyzer is running?

Other errors

YES
YES

NO
Is the voltage between J1.9
Other errors
and J1.10 about 0V? Is the on/off status of D1~D4(green) in the NO Fluid detection
fluid detection board consistent with the fluid board error
status detected by the photocouplers?

YES

Fluid detection YES


board error

NO
Voltage of the LIQ locus of Fluid detection
D1~D4 in J1 is above 4V when board error
on, and below 1V when off

YES

Other errors

Figure 8-23 Troubleshooting procedure

8.10. Indicator Board


8.10.1. Overview
The indicator board is connected with the digital control board, it receives signals from
the digital control board to indicate analyzer status.
8.10.2. Function
The indicator board has 2 basic functions:
Status indicating: the indicating system of the indicator board consists of 3 colors, which are
red, yellow and green, indicating different status of the analyzer.

8-39
Hardware System

Sound alarming: the buzzer in the indicator board provides sound alarm function when error
occurs.
8.10.3. Structure

Top

Bottom
Figure 8-24 The indicator board

8.10.4. Interfaces
The indicator board has 1 interface, J1. The definition of J1 is listed in the following table.

Table 8-33 Definition of J1

PIN Signal Description


Green indicator control signal, on when the electric
1 GREEN_LED
level is high, off when the level is low.
Yellow indicator control signal, on when the electric
2 YELLOW_LED
level is high, off when the level is low.
Red indicator control signal, on when the electric level
3 RED_LED
is high, off when the level is low.
4 GND Digital ground
Buzzer control signal, the buzzer beeps when electric
5 BUZ_N
level is low, and vice versa.
6 GND Digital ground
7 VCC 5V power, supplies power to the buzzer and indicator.
8 \ Reserved

8-40
Hardware System

8.10.5. Indicators and test points


Definitions of test points on the indicator board are listed in the following table.

Table 8-34 List of indicator board test points

Test
Printed label Function Note
point

TP1 VCC Test point of 5V power Normal voltage range 4.75V-5.25V

TP2 GND Ground test point Normal voltage range 4.75V-5.25V

Test point of green indicator


TP3 / 3.3V TTL level
control signal
Test point of yellow indicator
TP4 / 3.3V TTL level
control signal
Test point of red indicator
TP5 / 3.3V TTL level
control signal
When the indicator is on, the
Test point of green indicator
TP6 / electric level is low; when it is off,
working status
the electric level is high (5V).
When the indicator is on, the
Test point of yellow indicator
TP7 / electric level is low; when it is off,
working status
the electric level is high (5V).
When the indicator is on, the
Test point of red indicator
TP8 / electric level is low; when it is off,
working status
the electric level is high (5V).
8.10.6. Troubleshooting
There are 2 types of frequent indicator board error:
 The indicator fails to work as intended
Possible cause: the wire is not firmly connected to J1, or the indicator is damaged.
Solution: reconnect or replace the wire, or replace the LED indicator.
 The buzzer fails to work as intended
Possible cause: the wire is not firmly connected to J1, or the buzzer is damaged.
Solution: reconnect or replace the wire, or replace the buzzer.

8.11. Mini Network Board


8.11.1. Overview
The mini network board divides the channel in which the data board communicates the
PC into 2 parts, it is the transit point of the internal and external network cable of the
analyzer.
8.11.2. Function
The mini network board provides direct connection to the 2 RJ45 connector in and
outside the analyzer. See the following figure:

8-41
Hardware System

Figure 8-25 Functional diagram of the network board

8.11.3. Structure
The PCB of the mini network board (top and bottom) is as follows:

Figure 8-26 Top and bottom of mini network board PCBA

8.11.4. Interfaces
The pin definition of J1 and J2 interfaces is the same, see the following table.

Table 8-36 Pin definition of the mini network board interfaces

Signal
Pin I/O Description Level
name
1 TX_P I Connecting to data board UTP
TX_P
2 TX_N I Connecting to data board UTP
TX_N
3 RX_P O Connecting to data board UTP
RX_P
4 CT1_P I/O Connecting to data board UTP

8-42
Hardware System

Signal
Pin I/O Description Level
name
CT1_P
5 CT1_N I/O Connecting to data board UTP
CT1_N
6 RX_N O Connecting to data board UTP
RX_N
7 CT2_P I/O Connecting to data board UTP
CT2_P
8 CT2_N I/O Connecting to data board UTP
CT2_N

8.11.5. Indicators and test points


There are no indicators or test points on the board due to its simple function.

8.11.6. Troubleshooting
Table 8-37 Troubleshooting mini network board errors

Error causes
Error that are related
Troubleshooting method
phenomenon to the mini
network board
Step 1: Check if the network cable is loose. If
so, reconnect the cable to see if the error is
removed; if not, go to step 2.
1. The network
Step 2: Disassemble the mini network board,
The PC fails to cable is
test the conducting state of the pins of J1 and
connect to disconnected;
J2 with a universal meter. See the table above
BC-5300 or 2. circuit error or
for the pin definition of J1 and J2. If pin 1-8 of J1
BC-5100 poor contact of
can be conducted with pin 1-8 of J2, the mini
the interfaces.
network board is in normal status, the error
must be caused by other parts of the analyzer;
if not, the mini network board shall be replaced.

See the following flow chart.

8-43
Hardware System

The PC fails to
communicate with
BC-5300/BC-5100

YES
Reconnect the Does the cable connected
cable to mini network board get
loose?

NO

YES
Can pin 1~8 of J1 be
Other errors
conducted with pin
1~8 of J2

NO

Mini network
board error

Table 8-27 Troubleshooting mini network board errors

8.12. List of Prefixes of Board Sockets

Table 8-40 List of Prefixes of Board Sockets

Labeling
No. Board code Board name Quantity Prefix
mode

1 051-001146-00 Power board PCBA 1 A A-J1…

Pinaster main control


2 051-000985-00 1 B B-J1...
board PCBA

3 051-000982-00 Analog board PCBA 1 C C-J1…

4 051-000981-00 Drive board PCBA 1 D D-J1…

5 051-001062-00 Indicator board PCBA 1 G G-J1…

6 3102-30-69197 Key Board 1 H H-J1…

Fluid detection board


7 051-000983-00 1 I I-J1…
PCBA

8 3101-30-68513 Laser Control Board 1 J J-J1…

FS preamplification
9 3101-30-68515 1 K K-J1…
board
SS preamplification
10 3101-30-68517 1 L L-J1…
board
Mini network board
11 051-001122-00 1 M M-J1…
PCBA

8-44
Hardware System

8.13. Connections of Wires and Board

Table 8-41 Wires and Boards

Position
Board name Wire name Part No. Connecting to
No.
P24VP12VD5V power
D5V P12V and P24V
J11 009-002601-00 patch line
power extension line
(009-002286-00)
Mini network board
J1 Network patch line 009-002561-00
(051-001122-00) -J2

Indicator/key board Indicator board


009-002245-00
connecting line (051-001062-00) -J1
J78 Indicator board
Indicator board
connecting line of open 009-002500-00
(051-001062-00) -J1
vial model
Sample compartment
Door detection and
door detection and
009-002519-00 optical module
optical module
micro-switch
J79 connecting line
Pinaster main
Door detection and
control board Door detection and
aspirate key connecting 009-002274-00
PCBA aspirate key micro-switch
line
051-000985-00
Digital control board
Drive board PCBA
J81 and drive board 009-002275-00
(051-000981-00) -J13
connecting line
Connecting line of data Autoloading board PCBA
J8 board and autoloading 009-002271-00 (051-000393-00) -J11,
board serial port J12
Main control analog
Analog board PCBA
J85 board high-speed 009-002227-00
(051-000982-00) -J7
analog line
Main control analog
Analog board PCBA
J86 board low-speed 009-002228-00
(051-000982-00) -J8
analog line
Main control analog Analog board PCBA
J77 009-002229-00
board digital line (051-000982-00) -J9

Analog board J1 RBC/PLT signal line 3102-20-69109 RBC bath


PCBA
051-000982-00 J2 WBC signal line 3102-20-69113 WBC bath

8-45
Hardware System

Position
Board name Wire name Part No. Connecting to
No.
FS preamplification
board (3101-30-68515)
Optical system signal
J3 009-002225-00 -J1 and SS
line
preamplification board
(3101-30-68517) -J1

J4 HGB signal line 3102-20-69112 WBC bath

A±12V and AC120V


A±12V and AC120V
J5 009-002603-00 power output line
power extension line
(009-002287-00)
A±12V and AC120V
A±12V and AC120V
J24 009-002603-00 power output line
power extension line
(009-002287-00)
Optical system control Laser control board
J6 009-002226-00
line (3101-30-68513) -J1
Main control analog Pinaster main control
J7 board high-speed 009-002227-00 board PCBA
analog line (051-000985-00) -J85
Main control analog Pinaster main control
J8 board low-speed 009-002228-00 board PCBA
analog line (051-000985-00) -J86
Pinaster main control
Main control analog
J9 009-002229-00 board PCBA
board digital line
(051-000985-00) -J77
Drive board valve 13-29
J2 009-002272-00 Valve 13-28
connecting line

Drive board valve 1-12


J3 009-002284-00 Valve 1-12
connecting line

J4 Pump connecting line 009-002279-00 Pump 1-4

Drive board D5V and P12V power


D5V and P12V power
PCBA J6 009-002602-00 output line
extension line
051-000981-00 (009-002514-00)
Fluid detection board Fluid detection board
J7 009-002280-00
connecting line (051-000983-00) -J1

Temperature sensor
J8 009-002276-00 Temperature sensor
connecting line

Float switch connecting


J9 009-002278-00 Float switch
line

8-46
Hardware System

Position
Board name Wire name Part No. Connecting to
No.
Sample collection
Sample collection
J10 assembly photocoupler 009-002288-00
assembly photocoupler
connecting line
Syringe photocoupler
J11 009-002289-00 Syringe photocoupler
connecting line
Digital control board Pinaster main control
J13 and drive board 009-002275-00 board PCBA
connecting line (051-000985-00) -J81

J14 Heater connecting line 009-002277-00 Heater

P24VP12VD5V power
D5V P12V and P24V
J15 009-002601-00 patch line
power extension line
(009-002286-00)
Sample collection
Sample collection
J16 assembly motor 009-002466-00
assembly motor
connecting line
ASP_SP syringe motor
J17 009-002458-00 ASP motor and SP motor
connecting line

SH syringe assembly
J18 009-002457-00 SH motor
motor connecting line
LYSE_DIL syringe
LYSE and DIL syringe
J19 assembly motor 009-002283-00
motor
connecting line
Optical system control Analog board PCBA
Laser control J1 009-002226-00
line (051-000982-00) -J6
board
3101-30-68513 J2 Laser connecting line 3101-21-68593 Laser

FS
preamplification Optical system signal Analog board PCBA
J1 009-002225-00
board line (051-000982-00) -J3
3101-30-68515
SS
preamplification Optical system signal Analog board PCBA
J1 009-002225-00
board line (051-000982-00) -J3
3101-30-68517
Connecting line of the
Power board J1 switch and the power 3101-20-68589 Power switch
PCBA board
051-001146-00 A±12V and AC120V A±12V and AC120V
A-J12 009-002287-00
power output line power extension line

8-47
Hardware System

Position
Board name Wire name Part No. Connecting to
No.
(009-002603-00)

A±12V and AC120V


A±12V and AC120V
A-J13 009-002287-00 power extension line
power output line
(009-002603-00)
D5V P12V and P24V
P24VP12VD5V power
009-002286-00 power extension line
patch line
(009-002601-00)
A-J35
D5V and P12V power
D5V and P12V power
009-002514-00 extension line
extension line
(009-002602-00)
D5V P12V and P24V
P24VP12VD5V power
A-J37 009-002286-00 power extension line
patch line
(009-002601-00)
Fluid detection
Fluid detection board Drive board PCBA
board J1 009-002280-00
connecting line (051-000981-00) -J7
051-000983-00
Network cable
J1 (connecting the 009-000043-00 PC of the analyzer
Mini network
analyzer to PC)
board
Pinaster main control
051-001122-00
J2 Network patch line 009-002561-00 board PCBA
(051-000985-00) -J1
P24VP12VD5V power
24V-to-13V D5V P12V and P24V
J1 009-002601-00 patch line
power module power extension line
(009-002286-00)
PCBA
Drive board valve 13-29
051-001130-00 J2 009-002272-00 Valve 28
connecting line
Pinaster main control
Indicator/key board
009-002245-00 board PCBA
connecting line
Indicator board (051-000985-00) -J78
J1
051-001062-00 Indicator board Pinaster main control
connecting line of open 009-002500-00 board PCBA
vial model (051-000985-00) -J78
Pinaster main control
Key board Indicator/key board
J1 009-002245-00 board PCBA
3102-30-69197 connecting line
(051-000985-00) -J78

8-48
Hardware System

8.14. Motors, Photocouplers and Micro-switches

Table 8-42 Connections of wires and components on the power drive board

Connecting to Wire label Connecting to

P1-PRESS Pressure pump

Pump P2-WASTE Waste pump

P3-VACUUM Vacuum pump

Valve V1-V28 Valve 1 - Valve 28

AMBIENT Ambient temperature sensor

T1-OPTI Optical system temperature sensor

Temperature sensor T2-DIFF DIFF bath temperature sensor

T3-DIL Diluent temperature sensor

T4-RBC_DIL RBC inlet temperature sensor

F1-WASTE Waste float switch


Float switch
F2-DIL Diluent float switch

Starting position photocoupler of


SEN1-X_INIT sample collection assembly X
direction motor
Position photocoupler of sample
SEN2-X_POS collection assembly X direction
Sample collection assembly
motor
photocoupler
Starting position photocoupler of
SEN3-Y_START sample collection assembly Y
direction motor
Pressure relief valve detection
SEN5-VALVE
photocoupler

SEN6-ASP ASP syringe photocoupler

SEN7-SP SP syringe photocoupler

Syringe photocoupler SEN8-SH SH syringe photocoupler

SEN9-DIL DIL syringe photocoupler

SEN10-LYSE LYSE syringe photocoupler

Heater assembly HT1-OPTI Optical system heater

8-49
Hardware System

Connecting to Wire label Connecting to

HT2-DIFF DIFF bath heater

HT3-DIL Diluent heater

TS1-OPTI Optical system temperature switch

TS2-DIFF DIFF bath temperature switch

TS3-DIL Diluent temperature switch

Sample collection assembly X


M1-X
direction motor
Sample collection assembly motor
Sample collection assembly Y
M2-Y
direction motor

M3-ASP ASP motor

M4-SP SP motor

Syringe motor M5-SH SH motor

M6-DIL DIL motor

M7-LYSE LYSE motor

Table 8-43 Wires and micro-switches on the digital control board

Connecting to Wire label Connecting to

K1-ASPIRATE Aspirate key micro-switch

Micro-switch K2-R_DOOR Right door micro-switch

K3-OPTICS Optical module micro-switch

8.15. Analyzer Status Indicated by the Indicators


The analyzer status can be told from the following two aspects.
Analyzer power indicator: the power indicator in is in the left plate of the analyzer, as
shown in the figure below. The power indicator is in static green after the power switch in
turned on, which shows the power supply of the analyzer is normal. If the indicator is off
after the power switch is turned on, that means the power supply of the analyzer is
abnormal or the indicator is damaged, the analyzer shall not be started until the problem
is solved.

8-50
Hardware System

Figure 8-28 Power indicator

Analyzer working status indicator: the indicator is in the front cover of the analyzer, it
indicated the analyzer status using 3 different colors.

Table 8-44 Analyzer status indicated by the indicator

Analyzer status Indicator status

Power-off Off

Ready Static green

Running Flickering green

Running with error Flickering red

Error, not running Static red

Fluidic actions not allowed, no error Static yellow

Supporting superimposition of sample analyzing sequences Flickering yellow

8-51
9 Mechanical System

9.1. Analyzer Structure


The instrument is composed of the main unit and the PC, as well as the 3 lyses and diluent
connected to it.

9.2. Appearance
The front of the analyzer is shown as Figure9-1.

Figure 9-1 Front of the analyzer

1 ---- Power/Status indicator 2 ---- Sample probe


3 ---- Aspirate key

9-1
Mechanical System

The back of the main unit is shown as Figure9-2.

Figure 9-2 Back of the analyzer

1 --- Network interface 2 --- M-53D Diluent connector


3 --- M-53LH Lyse connector 4 --- M-53LEO(II) Lyse connector
5 --- M-53LEO(I) Lyse connector 6 --- Power input socket
7 --- Waste connector

9-2
Mechanical System

9.3. Layout Introduction


The layout of the components on the right plate are shown in Figure 9-3.

Figure 9-3 Right side of the main (right door open)

1 --- Optical system 2 --- Sampling assembly


3 --- Vacuum chamber 4 --- Reagent heating chamber
5 --- Fluidic valves 6 --- Vacuum pump/Waste pump
7 --- Measurement bath 8 --- DIFF bath

9-3
Mechanical System

The layout of the components on the left plate are shown in Figure 9-4.

Figure 9-4 Left side of the analyzer (left door open)

1 --- Fluidic valves 2 --- Syringe


3 --- Air pump 4 --- Liquid level detection unit
5 --- Pressure chamber 6 --- Fluidic valves
7 --- Power switch 8 --- Circuit board

9.4. Sampling Assembly


9.4.1. Structure Introduction
The sampling assembly is designed to aspirate, dispense, and mix the samples. The
sample probe moves in two directions:
1. X-Direction: go to the sampling, DIFF, WBC, RBC positions, and complete sample
mixing;
2. Y-Direction: complete sample fetching, sample probe cleaning, etc.

9-4
Mechanical System

Figure 9-5 The structure of the sampling assembly

X-direction mechanism consists of the horizontal bracket, X-direction guide bar, guide
bar fixer, synchronous belt and pulley, X-direction start position sensor, and motor. There
are notches on the horizontal bracket, each of which matches a position detection sensor
to detect the position

Figure 9-6 The structure of the X-direction assembly

For the closed-tube model, there are 5 positions on the X direction for the sample probe,

9-5
Mechanical System

which are (from back to front): RBC bath position, WBC bath position, DIFF bath position,
autoloading sampling position, closed-tube sampling position.
For the open-vial model, there are 4 positions on the X direction for the sample probe,
which are (from back to front): RBC bath position, WBC bath position, DIFF bath position,
and open-vial sampling position.

Figure 9-7 The structure of the Y-direction assembly

The sample probe is driven by the piercing slide. The rotation of the motor is transferred
into the linear motion by the lead screw nut set, which is the Y-direction motion guided by

9-6
Mechanical System

the guiding axle. The Y-direction start position sensor is installed on the piercing bracket,
and the barrier of the piercing slide is used as the barrier of the sensor, in order to locate
the Y-direction positions of the sample probe.

9.4.2. Maintaining the Assembly


For piercing force deficiency in Y-direction (for closed-tube models, error 0228 is usually
reported), follow the instructions below:
Check if any set screw fixing the Y-direction motor shaft on the lead screw is loose;
Check if any screw in the piercing bracket is loose;
Check if the assembly is well lubricated, and add some lubricant to the parts which have
sliding friction in Y direction (e.g. the ring contact surface of the Y-direction guide bar and
the piercing slide, lead screw nut set, etc.);
Check if the Y-direction sensor or motor is damaged. Replace with a new one if damaged.
For X-direction motion not in place (error 0201 is usually reported), follow the instructions
below:
Check if the press bar of the fixing belt is loose;
Check if the X-direction detection sensor comes into contact with the horizontal bracket in
the whole motion process, which damages the sensors or influence the proper operation of
the sensors;
Check if the X-direction sensor barrier comes into contact with the X-direction start position
sensor;
Check if the assembly is well lubricated, and add some lubricant to the parts which have
sliding friction in X direction (e.g. the ring contact surface of the X-direction guide bar and
the piercing bracket, the contact surface of the horizontal bracket and the rotation stop
block, etc.);
Check if the X-direction motor is damaged. Replace with a new one if damaged.
The following sections introduce the replacing procedures of motors and sensors (taking
closed-tube model as an example, the replacing procedures of which is similar to that of
the open-vial model).

9-7
Mechanical System

9.4.3. Replacing the X-Direction Start Position Sensors

Figure 9-8 Replacing the X-direction start position sensors of the sampling assembly

Remove the 2 M3x8 screws fixing the X-direction start position sensor bracket using a
cross-headed screwdriver, and then remove the X-direction start position sensors
together with the bracket from the analyzer. Remove the 2 M3x6 screws fixing the
sensors using a cross-headed screwdriver, and then remove the sensors. Install the new
sensors in the reversed order of the steps above.
You can also replace the sensors after removing the sampling assembly.
After the replacement, pull the Y-direction movement module, and check if the
X-direction start position sensor barrier are between the 2 sensors.

9-8
Mechanical System

9.4.4. Replacing X-Direction Detection Sensor

Figure 9-9 Replacing the X-direction detection sensors of the sampling assembly

Remove the 2 M3x5 screws fixing the X-direction detection sensor bracket using an inner
hexagon spanner, and then remove the X-direction detection sensors together with the
bracket from the analyzer. Remove the 2 M3x6 screws fixing the sensors using a
cross-headed screwdriver, and then remove the sensors. Install the new sensors in the
reversed order of the steps above.
You can also replace the sensors after removing the sampling assembly.
After the replacement, pull the X-direction movement module, and check if the fold of the
horizontal bracket (used as the barrier) is between the 2 sensors. Make adjustment if
necessary.

9.4.5. Replacing Y-Direction Sensor


Remove the 2 M3x6 screws fixing the Y-direction sensors using a cross-headed
screwdriver (as shown in the figure above), and then remove the sensors. Install the new
sensors in the reversed order of the steps above.
You can also replace the sensors after removing the sampling assembly.

9-9
Mechanical System

9.4.6. Replacing X-Direction Motor

Figure 9-10 Replacing the X-direction motor of the sampling assembly-1

Open the side covers, and then the front cover (as for open-vial models, remove the front
cover after opening the left and right top cover).
Remove the M3x8 screw fixing the sample probe and the fixing plate, and then dismantle
the probe wipe circlip. Remove the probe wipe, sample probe, and the fixing plate from
the sampling assembly. Note that when removing the M3x8 screw, press the M3 nut at
the back of the piercing slide to prevent from falling off; make sure that the tubing is not
damaged when you remove the probe wipe and sample probe.
Unplug the 3 cables which come from the and connect to the Y-direction motor,
Y-direction motor, and X-direction detection sensors of the sampling assembly. Remove
the 3 M3x8 screws and 1 M3x5 inner hexagon screw of the frontal protective plate using
the cross-headed screwdriver and inner hexagon spanner, and then remove the frontal
protective plate from the sampling assembly.
Unplug the connector of the cable connecting the X-direction start position sensors of the
sampling assembly, and remove the 4 M4x8 screws fixing the sampling assembly using
a cross-headed screwdriver; hold the whole sampling assembly and take it away from
the analyzer, and then unplug the cable connecting the sampling assembly to the
X-direction motor to remove it.

9-10
Mechanical System

Figure 9-11 Replacing the X-direction motor of the sampling assembly-2

Remove the 4 M3x8 screws (with washers) fixing the X-direction motor with a
cross-headed screwdriver, and then remove the motor with the driving band wheel fixed
on it.
Remove or loosen the 2 M3x5 set screws fixing the driving band wheel with an inner
hexagon spanner, and then remove the driving band wheel from the X-direction motor
shaft.
Install the X-direction motor in the reversed order of the steps above after the
replacement. Pay attention to the notes below while installing:
1. The distance from the driving band wheel to the end of the X-direction motor shaft is
2.5mm;
2. One of the set screws of the driving band wheel should be pressed to the flat of the
X-direction motor shaft;
3. While installing the X-direction motor on the sampling assembly, the cable coming out
of the motor should stand upwards (pointing to the top of the instrument);
4. While installing the X-direction motor on the sampling assembly, adjust the lengthwise
position, making the synchronous belt properly stretched; after the installation of the
sampling assembly, lean it to the left and then right, to see if the Y-direction movement
module can slide down properly;

9-11
Mechanical System

5. While installing the sampling assembly on the analyzer, make sure all cables and
tubes are well protected.

9.4.7. Replacing Y-Direction Motor


To replace the Y-direction motor, it is needed to remove the whole sampling assembly
from the analyzer (as instructed in the section above).

Figure 9-12 Replacing the Y-direction motor of the sampling assembly-1

As shown in the figure above, remove the 2 M3x10 inner hexagon screws fixing the
press bar of the synchronous belt using an inner hexagon spanner, remove the M4x8
screw fixing the horizontal guide bar and guide bar fixing pedestal using a cross-headed
screwdriver, remove the 2 M4x20 inner hexagon screws fixing the driven wheel
assembly using an inner hexagon spanner, and then demount the Y-direction movement
mechanism from the sampling assembly.

Figure 9-13 Replacing the Y-direction motor of the sampling assembly-2

9-12
Mechanical System

As shown in the figure above, remove or loosen the 2 M3x5 set screws fixing the
Y-direction guide bar using an inner hexagon spanner, remove the 4 M3x10 inner
hexagon screws (with spring and flat washers) fixing the Y-direction motor using an inner
hexagon spanner, and then remove the Y-direction motor.
Install the Y-direction motor in the reversed order of the steps above after the
replacement. Pay attention to the notes below while installing:
1. One of the set screws of the Y-direction guide bar should be pressed to the flat of the
Y-direction motor shaft;
2. While installing the Y-direction motor on the Y-direction movement mechanism, the
cable coming out of the motor should point at the sensor;
3. For proper installation of the Y-direction motor: secure the 4 M3x10 screws (with
spring and flat washers) fixing the motor first, and then the 2 M3x5 set screws.

9.5. Replace the Syringe Assembly


9.5.1. Structure Introduction
Structure of the 100ul syringe assembly

2
8

Figure 9-14 250ul lead screw driving syringe assembly

1 ---Syringe fixing plate 2 --- M3X6 cross-recessed panhead screw


with washer
3 ---100ul Mindray syringe 4 --- Tailored screw

9-13
Mechanical System

5 --- Baseplate 6 --- M3X6 cross-recessed panhead screw


7 --- Shielding cover 8---Sensor
9 --- Motor
Structure of 250ul lead screw driving syringe assembly

10
2

3 9

8
4

7
5

Figure 9-15 250ul lead screw driving syringe assembly

1 --- Motor 2 ---Syringe fixing plate


3 ---250ul (100ul) Mindray syringe 4 --- Tailored screw
5 --- Guide bar 6 --- M3X6 cross-recessed panhead screw
7 --- Lead screw 8---Sensor
9 --- Shielding cover 10 --- M3X6 cross-recessed panhead screw
with washer

9-14
Mechanical System

Structure of 2.5ml lead screw driving syringe assembly

1
11

10
3

4 9

5
8

Figure 9-16 2.5ml lead screw driving syringe assembly

1 ---Syringe fixing plate 2 --- M3X6 cross-recessed panhead screw


with washer
3 ---2.5ml Mindray syringe (silicon rubber) 4 --- 2.5ml Mindray syringe (fluororubber)
5 --- Tailored screw 6 --- Guide bar
7 --- M3X6 cross-recessed panhead screw 8 --- Lead screw
9 --- Shielding cover 10---Sensor
11 --- Motor

9-15
Mechanical System

Structure of 10ml lead screw driving syringe assembly

9
1

8
2

7
3

Figure 9-17 10ml lead screw driving syringe assembly

1 ---10ml die sinking syringe 2 --- M3X25 cross-recessed panhead screw


3 --- Tailored screw 4 --- Guide bar
5 --- M3X6 cross-recessed panhead screw 6 --- Lead screw
7 --- Shielding cover 8 --- Sensor
9 --- Motor

9.5.2.Relevant Troubleshooting Measures


Troubleshooting/Solut
Error Code Error Name Trigger of Error Report
ion
1. Sensors are still blocked Sensor error or excessive
when the syringe is out of the motor assembly
detection area in initialization; resistance which leads to
2. Sensors are not blocked step loss or operation
Sampling syringe when the syringe is inside obstruction.
0x01000301
sensor error sensor detection area in Low possibility of
initialization; occurrence.
3. Should not be at the start 1. Check if the software
position after resetting, but the version and hardware
sensors are blocked. version are correct, and if
Sampling syringe the 24V, 12V and 5V
Sensor not blocked when the
aspiration/dispen power are proper;
0x01000302 syringe is supposed to be at
sation action 2. Check if the cables of
the start position;
failure 1 the sensors and motors

9-16
Mechanical System

Troubleshooting/Solut
Error Code Error Name Trigger of Error Report
ion
Sampling syringe are well connected and
Sensor blocked when the
aspiration/dispen make sure there is no
0x01000303 syringe is supposed to be out
sation action bad connection;
of the start position
failure 2 3. Click "Remove Error" to
Sample syringe When the syringe starts see if it can be removed;
aspiration/dispen moving, it is supposed to be at 4. Perform self-test at the
0x01000304
sation action not the start position, but the "Self-test" screen;
allowed 1 sensor is not blocked; 5. When the motor is
Sampling syringe When the syringe starts operating, check if the
aspiration/dispen moving, it is supposed to be LED indicator of the
0x01000305
sation action not out of the start position, but the corresponding channel
allowed 2 sensor is blocked; (ASP-M3_LED2;SP-M4_L
1. Sensors are still blocked ED2, SH-M5_LED2,
when the syringe is out of the DIL-M6_LED2,
detection area in initialization; LYSE-M7_LED2) is
2. Sensors are not blocked flickering. If not, replace
Sample injection
when the syringe is inside the driver board;
0x01000311 syringe sensor
sensor detection area in 6. Check if the sensor
error
initialization; states are different when it
3. Should not be at the start is blocked and unblocked;
position after resetting, but the 7. Find the sensor with
sensors are blocked. error and remove it. Check
Sample injection if there is dust or splashed
syringe Sensor not blocked when the fluid covering the glittering
0x01000312 aspiration/dispen syringe is supposed to be at side;
sation action the start position; 8. Wipe the sensor and
failure 1 mount it back to see if the

Sample injection error can be removed. If

syringe Sensor blocked when the not, replace with a new

0x01000313 aspiration/dispen syringe is supposed to be out one;

sation action of the start position 9. Check if the syringe

failure 2 assembly is well installed;

Sample injection remove the shielding

syringe Sensor not blocked when the cover, wipe the lead screw

0x01000314 aspiration/dispen syringe is supposed to be at and the guide bar, and add

sation action not the start position; lubricant;

allowed 1 10. If the error still exists,

Sample injection replace the corresponding

syringe Sensor blocked when the syringe assembly with a

0x01000315 aspiration/dispen syringe is supposed to be out new one.

sation action not of the start position


allowed 2

9-17
Mechanical System

Troubleshooting/Solut
Error Code Error Name Trigger of Error Report
ion
1. Sensors are still blocked
when the syringe is out of the
detection area in initialization;
2. Sensors are not blocked
Sheath fluid
when the syringe is inside
0x01000321 syringe sensor
sensor detection area in
error
initialization;
3. Should not be at the start
position after resetting, but the
sensors are blocked.
Sheath fluid
syringe Sensor not blocked when the
0x01000322 aspiration/dispen syringe is supposed to be at
sation action the start position;
failure 1
Sheath fluid
syringe Sensor blocked when the
0x01000323 aspiration/dispen syringe is supposed to be out
sation action of the start position
failure 2
Sheath fluid
syringe Sensor not blocked when the
0x01000324 aspiration/dispen syringe is supposed to be at
sation action not the start position;
allowed 1
Sheath fluid
syringe Sensor blocked when the
0x01000325 aspiration/dispen syringe is supposed to be out
sation action not of the start position
allowed 2
1. Sensors are still blocked
when the syringe is out of the
detection area in initialization;
2. Sensors are not blocked
Lyse syringe when the syringe is inside
0x01000331
sensor error sensor detection area in
initialization;
3. Should not be at the start
position after resetting, but the
sensors are blocked.
Lyse syringe Sensor not blocked when the
0x01000332
aspiration/dispen syringe is supposed to be at

9-18
Mechanical System

Troubleshooting/Solut
Error Code Error Name Trigger of Error Report
ion
sation action the start position;
failure 1
Lyse syringe
Sensor blocked when the
aspiration/dispen
0x01000333 syringe is supposed to be out
sation action
of the start position
failure 2
Lyse syringe
Sensor not blocked when the
aspiration/dispen
0x01000334 syringe is supposed to be at
sation action not
the start position;
allowed 1
Lyse syringe
Sensor blocked when the
aspiration/dispen
0x01000335 syringe is supposed to be out
sation action not
of the start position
allowed 2
1. Sensors are still blocked
when the syringe is out of the
detection area in initialization;
2. Sensors are not blocked
Diluent syringe when the syringe is inside
0x01000341
sensor error sensor detection area in
initialization;
3. Should not be at the start
position after resetting, but the
sensors are blocked.
Diluent syringe
Sensor not blocked when the
aspiration/dispen
0x01000342 syringe is supposed to be at
sation action
the start position;
failure 1
Diluent syringe
Sensor blocked when the
aspiration/dispen
0x01000343 syringe is supposed to be out
sation action
of the start position
failure 2
Diluent syringe
Sensor not blocked when the
aspiration/dispen
0x01000344 syringe is supposed to be at
sation action not
the start position;
allowed 1
Diluent syringe
Sensor blocked when the
aspiration/dispen
0x01000345 syringe is supposed to be out
sation action not
of the start position
allowed 2
10ml syringe Replace a new Mindray
/ /
leakage syringe. The replacement

9-19
Mechanical System

Troubleshooting/Solut
Error Code Error Name Trigger of Error Report
ion
should be performed as
follows: remove the
tailored screw, and then
the 4 MX25 screws fixing
the syringe. Unplug the
tubes, and replace the
syringe with a new one.
Replace a new Mindray
syringe. The replacement
should be performed as
follows: remove the
100ul/250ul/2.5m
/ / tailored screw, and then
l syringe leakage
the 4 MX25 syringing
fixing plate. Unplug the
tubes and remove the
syringe for replacement.

9.6. Debug Screen Introduction


For open-vial models, if any part of the sampling assembly is replaced, it is necessary to
check and adjust the mechanical positions (Sample Probe Up Position/Probe Wipe Position,
DIFF Bath Up Position)
The adjustment can be completed at the "Debug" screen.
Click "Menu→Service→Debug" to enter the "Debug" screen.

Figure 9-18 Debug screen of open-vial models

Note 1: after clicking "Start", the assembly should be at the default position, not the adjusted
position; after clicking "Start", the button changes into "Save". The adjustment only takes
effect if you click "Save" after the adjustment. The "Check" button is used to simulate the
actions in normal sample analysis process. Remember to remove the fixtures as instructed.
Note 2: Click the "Coarse Adjust" (bottom left) button to switch to "Fine Adjust", and click
again to switch back. When the button shows "Coarse Adjust", it means the current state of
motor adjustment is "Fine Adjust", when the motor moves 2 steps by one click; when the
button shows "Fine Adjust", it means the current state of motor adjustment is "Coarse Adjust",
when the motor moves 20 steps by one click

9-20
Mechanical System

Note 3: in the horizontal movement of the sampling assembly, the stride of one step is
0.16mm; in vertical movement, 0.04mm.

9.7. Adjusting the Position of the Sample Probe


The adjustment of sample probe positions include the adjustment of:
 Sample probe up position (probe wipe position)
 DIFF bath up position
Tools needed for the adjustment include:
 Cross-headed screwdriver
 Ruler
 Fitting pin or sample probe up position fixture

9.7.1. Sample Probe Up Position Adjustment


Adjustment: select "Sample Probe Position →Sample Probe Up Position", and then click
"Start". Use the "Up" and "Down" buttons to adjust the sample probe tip to be level with the
bottom surface of the probe wipe.
Check: click "Save", and then "Check". Use the sample probe wipe up position fixture to
check the adjusted position as instructed by the figures below:

Figure 9-19 Sample Probe Up Position Adjustment

If the requirements are not met, adjust again using the "Up" and "Down" buttons.
If there is no fixture, use a ruler and the fitting pin. For open-vial models, it is required that the
sample probe is inside the probe wipe, and the probe tip is 5.3±0.2mm up from the bottom of
the probe wipe; for closed-tube models, the probe tip should be 7.2±0.2mm up from the
bottom of the probe wipe.

9-21
Mechanical System

9.7.2. DIFF Bath Up Position Adjustment


Select "Sample Probe Position →Sample Probe Up Position", and then click "Check" to make
the sample probe inside the DIFF bath. Check if the distance from the center of the sample
probe to the inner surface of the DIFF bath (the side close to the frontal plate) is about
2.5mm.
1) If not, click "Start" in the "Sample Probe Position →Sample Probe Up Position" area, and
then use the "Forward" and "Backward" buttons to adjust the sampling position.
2) When the adjustment finishes, click "Save", and then "Check", to confirm the DIFF bath
sampling position.
Exit the "Debug screen" and run a blank count cycle. Make sure that the sample probe do not
touch the bath during DIFF bath mixing, WBC bath Mixing, and RBC bath mixing.

9.8.HGB Assembly Replacement


Table 9-1 Difference between old and new circuit boards

Circuit board figure/PN Compatible HGB assembly Dial method Applicable


version
Old Old HGB assembly Applicable
circuit (applicable to version to version
board before EJ295F) before
3101-30-68379 Transmitter EJ295F
and receiver assembly
3101-30-68541 HGB
Assembly
3101-30-68538 WBC
Assembly
3101-30-68540 Counting cell
assembly
PN:051-000982-00 115-059670-00 calculating
instrument assembly
New New HGB assembly with Applicable
circuit “new 新 ” label (applicable to EJ295F
board to EJ295F and later version) and later
version

New label
location

PN:051-000982-01

3101-30-68379 Transmitter
and receiver assembly

9-22
Mechanical System

Dial switch + label 3101-30-68541 HGB


Assembly
3101-30-68538 WBC
Assembly
3101-30-68540 Counting cell
assembly
115-059670-01 calculating
instrument assembly(New
LED)
Old HGB assembly
(applicable to version
before EJ295F)
3101-30-68379 Transmitter
and receiver assembly
3101-30-68541 HGB
Assembly
3101-30-68538 WBC
Assembly
3101-30-68540 Counting cell
assembly
115-059670-00 calculating
instrument assembly

9.8.1.Maintenance Protocol

9.8.1.1.Error Phenomenon
After replacing the HGB assembly, the HGB blank voltage can’t reach the required range.

9.8.1.2.Solution
Maintenance scenario 1: new circuit board + new HGB assembly
1.Replace a new HGB circuit board.
2.Adjust the dial switch on the circuit board according to the following method.

3.Verify whether the adjustment has achieved satisfactory results referring to “Verification
after Replacement and Adjustment (Applicable to Maintenance Scenario 1&2)”.

Maintenance scenario 2: new circuit board + old HGB assembly


1.Replace a new HGB circuit board.
2.Adjust the dial switch on the circuit board according to the following method.

9-23
Mechanical System

3.Verify whether the adjustment has achieved satisfactory results referring to “Verification
after Replacement and Adjustment (Applicable to Maintenance Scenario 1&2)”

Maintenance scenario 3: old circuit board + old HGB assembly


The HGB circuit can’t be adjusted by adjusting dial switch when the old HGB circuit
board is used. Adjust it on the “Gain Setup” screen if necessary.
If you cannot adjust the HGB circuit to the normal level on the “Gain Setup” screen, replace a
new circuit board, then adjust the circuit according to the “Maintenance scenario 2”.

9.8.1.3.Verification after Replacement and Adjustment (Applicable to


Maintenance Scenario 1&2)
Login to the analyzer software using the service account, go to “Gain Setup” screen, check
whether the HGB blank voltage reaches the required range. If not, adjust the HGB gain
according to the following flowchart.

Adjust the HGB gain using


service account

YES Whether the HGB blank


voltage reaches the
required range

NO

Adjust the HGB blank voltage


according to the dial method in
the above table

Finish

9-24
P/N: 3101-20-68567(5.0)

You might also like