BC-6000 - Service Manual - V5.0 - EN PDF [PDF]

Zitiervorschau

BC-6000 Series Auto Hematology Analyzer

Service Manual Models: BC-6000/BC-6000Plus/ BC-6100/BC-6100Plus/BC-6200

© 2016-2019 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issued Date is 2019-11.

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. , China and other countries.

are the trademarks, registered or otherwise, of Mindray in 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 changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor 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.



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 injury of human health.



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

NOTE 

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

Repair Service Free Service: Free service is provided for any product within the scope specified by Mindray warranty rules. Paid Service: Mindray offers paid service for any product beyond the scope specified by Mindray warranty rules; Even during the warranty period, only paid service is available if the need for service is caused by the following reasons: artificial damage; improper use; grid voltage beyond the specified range of the device; irresistible natural disasters; replacement with parts and consumables not authorized by Mindray or service work by personnel not authorized by Mindray.

Return Procedure In the event that it becomes necessary to return this product or part of this product to Mindray, the following procedure should be followed: Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. Freight policy: The customer is responsible for freight charges when shipping the product to Mindray for service (including customs charges).

II

Customer Service Department Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057,P.R.China

Website:

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680 EC-Representative:

Shanghai International Holding Corp. GmbH(Europe)

Address:

Eiffestraβe 80, Hamburg 20537, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

III

Table of Contents Chapter 1 Using This Manual .................................................................................. 1-1 1.1

Who is to Using this Manual ............................................................................. 1-2

1.2

Using This Manual ........................................................................................... 1-3

1.3

Labels and Symbols on the Analyzer ................................................................ 1-4

1.4

Safety Information .......................................................................................... 1-12

1.5

Term Definition ............................................................................................... 1-15

Chapter 2 System Introduction ............................................................................... 2-1 2.1

Intended Use ................................................................................................... 2-1

2.2

Parameters ...................................................................................................... 2-2

2.3

Product Description .......................................................................................... 2-7 2.3.1 Product Structure and Components............................................................ 2-7 2.3.2 Modules and Components ......................................................................... 2-7 2.3.3 Accessories List of the Analyzer ............................................................... 2-15 2.3.4 Tubes and Tube Racks............................................................................. 2-16

2.4 2.5

Overview of Software Interfaces ..................................................................... 2-18 Reagents, Controls and Calibrators ................................................................ 2-22 2.5.1 Reagents ................................................................................................. 2-22 2.5.2 Controls and Calibrators........................................................................... 2-24

Chapter 3 System Principles ................................................................................... 3-1 3.1

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

3.2

WBC Measurement .......................................................................................... 3-2 3.2.1 SF CUBE Cell Analysis Technology ............................................................ 3-2 3.2.2 WBC-Related Parameters .......................................................................... 3-3

3.3

Derivation of NRBC-Related Parameters .......................................................... 3-6

3.4

Hemoglobin Concentration Measurement ......................................................... 3-7 3.4.1 A Test Model Using the Colorimetric Method ............................................... 3-7 3.4.2 HGB Measurement .................................................................................... 3-7

3.5

RBC/PLT Measurement.................................................................................... 3-8 3.5.1 Impedance Method .................................................................................... 3-8 3.5.2 SF CUBE Cell Analysis Technology ............................................................ 3-9 3.5.3 RBC-Related Parameters........................................................................... 3-9 3.5.4 PLT-Related Parameters ............................................................................ 3-9 3.5.5 Reticulocyte Parameters .......................................................................... 3-10

3.6

Body Fluid Parameters ................................................................................... 3-12

3.7

Flush.............................................................................................................. 3-13

Chapter 4 Software System ..................................................................................... 4-1 4.1

Login Password ............................................................................................... 4-1 4.1.1 System Self-test When Logging in at Service Access Level ........................ 4-1

4.2

Calibration........................................................................................................ 4-2 4.2.1 Manual Calibration ..................................................................................... 4-2 4.2.2 Calibration with Calibrators......................................................................... 4-3 1

Table of Contents

4.3

Optical Gain Calibration ................................................................................... 4-6

4.4

Review ............................................................................................................. 4-7 4.4.1 Export ........................................................................................................ 4-7 4.4.2 Special information .................................................................................... 4-8

4.5

Setup screen .................................................................................................... 4-9 4.5.1 Maintenance .............................................................................................. 4-9 4.5.2 Reagent Setup ........................................................................................... 4-9 4.5.3 Communication ........................................................................................ 4-12 4.5.4 Gain Setup............................................................................................... 4-13 4.5.5 Auxiliary Setup ......................................................................................... 4-13

4.6

Debug & Self-Test .......................................................................................... 4-15 4.6.1 Adjust. Sample Probe Positions................................................................ 4-15 4.6.2 Adjust Autoloader Position........................................................................ 4-16 4.6.3 Auto-loading Debug.................................................................................. 4-17 4.6.4 Sensor Debug .......................................................................................... 4-18 4.6.5 Optical Debug .......................................................................................... 4-19

4.7

Status ............................................................................................................ 4-20

4.8

Indicators ....................................................................................................... 4-20

4.9

Advanced Toolbox .......................................................................................... 4-22 4.9.1 Language Setup....................................................................................... 4-22 4.9.2 Debug Data Export .................................................................................. 4-22 4.9.3 Enable “Low Speed Scan” for Low Quality Sample Barcode ..................... 4-24

4.10

Software Update ............................................................................................ 4-26 4.10.1 Prepare the USB for update ................................................................... 4-26 4.10.2 Update ................................................................................................... 4-26 4.10.3 When Update Fails................................................................................. 4-27

4.11

Communication Troubleshooting .................................................................... 4-28

Chapter 5 Mechanical System ................................................................................. 5-1 5.1

Introduction to Mechanical Structure................................................................. 5-1 5.1.1 Front Side of the Analyzer .......................................................................... 5-2 5.1.2 Rear Side of the Analyzer........................................................................... 5-3 5.1.3 Left Side of the Analyzer ............................................................................ 5-4 5.1.4 Right Side of the Analyzer .......................................................................... 5-4

5.2

Mechanics Subsystem Introduction .................................................................. 5-6 5.2.1 Autoloader ................................................................................................. 5-6 5.2.2 Rotary Scanning Assembly (With Built-in Scanner) ................................... 5-25 5.2.3 Test Tube Stabilizing Mechanism.............................................................. 5-31 5.2.4 Mixing Assembly ...................................................................................... 5-35 5.2.5 Sampling assembly .................................................................................. 5-41 5.2.6 Syringe Assembly .................................................................................... 5-50 5.2.7 Temperature Control Module .................................................................... 5-51

Chapter 6 Optical System ........................................................................................ 6-1 6.1

Fundamentals of Optical System ...................................................................... 6-1

6.2

Composition of the Optical System ................................................................... 6-3 2

Table of Contents

6.3

Troubleshooting Optical Faults ......................................................................... 6-5 6.3.1 Scattergram Abnormal ............................................................................... 6-5 6.3.2 Laser Diode Current Abnormal ................................................................... 6-7 6.3.3 When the Optical Gain Cannot be Calibrated ............................................. 6-8 6.3.4 Maintenance and Replacement of Optical System ...................................... 6-9 6.3.5 Replacing Optical Assembly after Analyzer Upgrading with the New Optical Assembly and New Optical Signal Board (After EIV013) ................................... 6-12

Chapter 7 Fluidics System ...................................................................................... 7-1 7.1

Fluidics System Overview ................................................................................ 7-1

7.2

Measurement Flow........................................................................................... 7-3

7.3

Sample Dilution Flow Chart .............................................................................. 7-4 7.3.1 Whole blood mode ..................................................................................... 7-4 7.3.2 Prediluted mode ......................................................................................... 7-5

7.4

Sample Volume ................................................................................................ 7-6

7.5

Time of Preparation and Measurement ............................................................. 7-7

7.6

Temperature Control for Fluidics System .......................................................... 7-8

7.7

Reagent Consumption Volume ......................................................................... 7-9

7.8

Fluidic Parts and Functions ............................................................................ 7-12 7.8.1 Sample probe .......................................................................................... 7-12 7.8.2 Probe Wipe .............................................................................................. 7-12 7.8.3 Pumps ..................................................................................................... 7-12 7.8.4 Syringe .................................................................................................... 7-13 7.8.5 Valves ...................................................................................................... 7-13 7.8.6 Baths ....................................................................................................... 7-16 7.8.7 Filters....................................................................................................... 7-17 7.8.8 Liquid Pressure Detection Components.................................................... 7-18

7.9

Pneumatic System ......................................................................................... 7-19 7.9.1 Pneumatic System Introduction ................................................................ 7-19 7.9.2 Introduction of Pneumatic Parts and Functions ......................................... 7-19

7.10

Fluidic Channels and Fluidic Structure ............................................................ 7-20 7.10.1 WNB Channel ........................................................................................ 7-20 7.10.2 DIFF Channel ........................................................................................ 7-21 7.10.3 RET Channel ......................................................................................... 7-22 7.10.4 RBC/PLT Channel .................................................................................. 7-23 7.10.5 HGB Channel ......................................................................................... 7-24

7.11

Introduction to Sequences .............................................................................. 7-25 7.11.1 CT-WB Analysis Sequences ................................................................... 7-25 7.11.2 CT-micro-WB Analysis Sequences ......................................................... 7-29 7.11.3 CT-PD Analysis Sequences .................................................................... 7-30 7.11.4 Autoloading Whole-Blood Analysis Sequences ....................................... 7-30

7.12

Fluidics Diagram ............................................................................................. 7-31

7.13

Check the Particle Flow Stability..................................................................... 7-33

Chapter 8 Hardware System .................................................................................... 8-1 8.1

Hardware System Overview ............................................................................. 8-1 3

Table of Contents

8.1.1 Functional block diagrams .......................................................................... 8-1 8.1.2 Electrical Connection Block Diagram and the Positions in Analyzer ............ 8-2 8.2

Main control board and COME substrate assembly (115-042843-00) ................ 8-8 8.2.1 Overview.................................................................................................... 8-8 8.2.2 Function..................................................................................................... 8-8 8.2.3 Structure and Test .................................................................................... 8-10 8.2.4 Troubleshooting ....................................................................................... 8-13

8.3

Drive board (051-002835-00) ......................................................................... 8-15 8.3.1 Function................................................................................................... 8-15 8.3.2 Structure and Test .................................................................................... 8-16 8.3.3 Troubleshooting ....................................................................................... 8-19

8.4

Analog board (051-002815-00) ....................................................................... 8-20 8.4.1 Function................................................................................................... 8-20 8.4.2 Structure and Test .................................................................................... 8-20 8.4.3 Troubleshooting ....................................................................................... 8-22

8.5

Autoloader Board (051-002829-00) ................................................................ 8-23 8.5.1 Function................................................................................................... 8-23 8.5.2 Structure and Test .................................................................................... 8-23 8.5.3 Troubleshooting ....................................................................................... 8-25

8.6

Valve Drive Board (051-002805-00)................................................................ 8-26 8.6.1 Function................................................................................................... 8-26 8.6.2 Structure .................................................................................................. 8-26 8.6.3 Troubleshooting ....................................................................................... 8-27

8.7

Power Supply Module .................................................................................... 8-28 8.7.1 Overview.................................................................................................. 8-28 8.7.2 Structure and Test .................................................................................... 8-29 8.7.3 Power Indication ...................................................................................... 8-34 8.7.4 Troubleshooting ....................................................................................... 8-37

8.8

Boards in the Optical System ......................................................................... 8-38 8.8.1 Function................................................................................................... 8-38

8.9

Indicator Board (051-001240-00) .................................................................... 8-39 8.9.1 Function................................................................................................... 8-39 8.9.2 Troubleshooting ....................................................................................... 8-39

8.10

Keyboard (051-001568-00) ............................................................................ 8-40 8.10.1 Function ................................................................................................. 8-40 8.10.2 Troubleshooting ..................................................................................... 8-40

8.11

Mini Network Board (051-001122-00) ............................................................. 8-41 8.11.1 Function ................................................................................................. 8-41 8.11.2 Troubleshooting...................................................................................... 8-41

8.12

Liquid Position Detecting Board (051-000565-00) ........................................... 8-42 8.12.1 Function ................................................................................................. 8-42 8.12.2 Structure and Test .................................................................................. 8-42 8.12.3 Troubleshooting ..................................................................................... 8-43

8.13

Air Pressure Detection Board (051-000507-00) .............................................. 8-44 4

Table of Contents

8.13.1 Function ................................................................................................. 8-44 8.13.2 Structure ................................................................................................ 8-44 8.13.3 Troubleshooting ..................................................................................... 8-45 Chapter 9 FRU Replacement and Debugging ......................................................... 9-1 9.1

Overview.......................................................................................................... 9-1

9.2

Removal and Installation of the Panels ............................................................. 9-2 9.2.1 Opening the Front Cover Assembly ............................................................ 9-2 9.2.2 Opening the Left Panel, Right Panel and Top Cover ................................... 9-3

9.3

Replacing the Autoloader FRU ......................................................................... 9-5 9.3.1 Removing and Replacing the Loading Motor and Belt................................. 9-6 9.3.2 Removing and Replacing the Loading Sensor ............................................ 9-7 9.3.3 Removing and Replacing the Feeding Motor and Belt ................................ 9-8 9.3.4 Removing and Replacing the Feeding sensor........................................... 9-10 9.3.5 Removing and Replacing the Unloading Motor and Belt ........................... 9-10 9.3.6 Removing and Replacing the Unloading Sensor ....................................... 9-12 9.3.7 Removing and Replacing the Back Supporting Board ............................... 9-13

9.4

Replacing the Tube Stabilizing Assembly FRU ............................................... 9-14 9.4.1 Removing and Replacing the Compressing Spring Piece and Spring........ 9-14

9.5

Introduction to Rotatory Scanning Component ................................................ 9-16 9.5.1 Removing and Replacing the Motor and Roller Sleeve ............................. 9-17

9.6

Introduction to Pincher Roller Assembly.......................................................... 9-19 9.6.1 Removing and Replacing the Motor, Sensors and Pinch Roller Spring ...... 9-20

9.7

Introduction to Sampling Assembly and Replacement Procedure .................... 9-22 9.7.1 Removing and Replacing Detection Sensor .............................................. 9-22 9.7.2 Removing and Replacing Probe Wipe (Closed-Sampling) and Sampling Probe ......................................................................................................................... 9-23 9.7.3 Removing and Replacing Y Direction Motor and Z Direction Motor ........... 9-25

9.8

Introduction to mix assembly .......................................................................... 9-28 9.8.1 Removing and Replacing Detection Sensor .............................................. 9-29 9.8.2 Removing and Replacing Motor ............................................................... 9-30

9.9

Gain Adjustment............................................................................................. 9-33

9.10

Installing and Adjusting Rotary Scanning Device ............................................ 9-35

Chapter 10 Maintenance .......................................................................................... 10-1 10.1

Recommended Maintenance .......................................................................... 10-1

10.2

Active Maintenance ........................................................................................ 10-2 10.2.1 Pre-maintenance Preparations ............................................................... 10-2 10.2.2 Maintenance Plan and Content .............................................................. 10-2 10.2.3 Check the Instrument Status ................................................................ 10-23 10.2.4 Confirm the General Performance of the Instrument ............................. 10-24 10.2.5 Data Backup and Export ...................................................................... 10-25

10.3

Standard Operation Procedures of QC and Calibration ................................. 10-29 10.3.1 Quality Control ..................................................................................... 10-29 10.3.2 Calibration ........................................................................................... 10-29 10.3.3 Mixing Methods of Mindray Self-made Quality Controls and Calibrator . 10-29 5

Table of Contents

Chapter 11 Troubleshooting Information................................................................ 11-1 11.1

Introduction .................................................................................................... 11-1

11.2

Message Area Codes ..................................................................................... 11-3 11.2.1 Reagent Type ......................................................................................... 11-3 11.2.2 Waste-Related Errors ............................................................................. 11-6 11.2.3 Floater-Related Errors ............................................................................ 11-8 11.2.4 Syringe Type .......................................................................................... 11-9 11.2.5 Sampling Assembly-related Errors ........................................................ 11-14 11.2.6 Mix Assembly-Related Type.................................................................. 11-17 11.2.7 Autoloader-Related Errors .................................................................... 11-21 11.2.8 Sample Compartment Assembly Errors ................................................ 11-28 11.2.9 Temperature Type Errors ...................................................................... 11-30 11.2.10 Pressure Errors .................................................................................. 11-34 11.2.11 Voltage/Current Errors ........................................................................ 11-36 11.2.12 Fan Type ............................................................................................ 11-37 11.2.13 Signal type ......................................................................................... 11-38 11.2.14 Communication Type .......................................................................... 11-39 11.2.15 System Errors .................................................................................... 11-40 11.2.16 Additional Warning Messages in the “Message” Area (Since EIV012).. 11-41

A

List of Wearing Parts ............................................................................. A-1

B

New/Changed Functions Lists with each ECR ..................................... B-1

6

Chapter 1 Using This Manual This chapter describes how to use the service manual. In this manual, the repair methods of the BC-6000 series analyzers are described in detail. Before servicing the BC-6000 series analyzers, please carefully read and understand the content in order to properly carry out maintenance procedures and ensure the safety of service personnel. This manual must be used in conjunction with the BC-6000 series Operator’s manual. It does not contain information and procedures already covered in the Operator’s manual of the BC6000 series analyzers.

NOTE 

Be sure to operate and service the analyzer strictly as instructed in this manual and the operator's manual.

1-1

Using This Manual

1.1 Who is to Using this Manual This manual is intended to be read by service professionals who: 

Have comprehensive knowledge of circuitry and fluidics;



Have comprehensive knowledge of reagents;



Have comprehensive knowledge of quality control;



Have comprehensive knowledge of troubleshooting;



Are familiar with the operations of the system;



Are able to use basic mechanical tools and understand the terminology;



Are skilled users of the digital voltmeter and oscillograph;



Are able to analyze the circuit diagrams and fluidic charts.

1-2

Using This Manual

1.2 Using This Manual This manual comprises 11 chapters and 1 appendix. Refer to the table below to find the information you need. When you need to...

See...

learn about the analyzer's system composition and

Chapter

software structure

Introduction

learn about the analyzer's installation requirements and

Chapter

software upgrade methods

Principles

learn about the basic functions of the Analyzer software

Chapter 4 Software System

learn about the composition of the Analyzer's mechanical

Chapter

system components

System

learn about the analyzer's optical system and optical

Chapter 6 Optical System

2

System

3

System

5

Mechanical

system main fault repair methods learn about the composition, dosage, basic channels and

Chapter 7 Fluidics System

time sequence of the analyzer's fluidic system learn about the analyzer's hardware structure; composition,

Chapter

adjusting, testing points and troubleshooting of each board

System

learn about how to replace and debug analyzer FRUs

Chapter

8

Hardware 9

Replacement

FRU and

Debugging learn about the analyzer maintenance method

Chapter 10 Maintenance

learn about the analyzer's errors and troubleshooting

Chapter 11 Troubleshooting Information

learn about the analyzer's main accessories

A.1.1.1.1.A.1AList Wearing Parts

1-3

of

Using This Manual

1.3 Labels and Symbols on the Analyzer You may find the following symbols on package or the body of the instrument:

CAUTION 

During the daily use of the instrument, especially the cleaning process, the operator shall ensure the intactness of the labels.

When you see...

It means... Caution Consult the accompanying documents In all cases where this symbol is marked to find the nature of the potential HAZARDS and any actions have to be taken to avoid them BIOLOGICAL RISK WARNING, LASER BEAM PROTECTIVE EARTH (GROUND)

Off (Power) On (Power) CAUTION, RISK OF ELECTRIC SHOCK

Alternating current SERIAL NUMBER FOR IN VITRO DIAGNOSTIC USE DATE OF MANUFACTURE Temperature limitation

1-4

Using This Manual

HUMIDITY LIMITATION

Atmospheric Pressure limit

Biological risks (on the tube of the waste container cap assembly) Do not replace the waste container when the power indicator is flickering! THE DEVICE IS FULLY CONFORMANCE WITH THE COUNCIL DIRECTIVE

CONCERNING

IN

VITRO

DIAGNOSTIC MEDICAL DEVICES 98/79/EC. Applicable to closed-sampling type analyzers Warning The probe is sharp and may contain biological contaminants. Be careful when operating it! Applicable to closed-sampling models Indicate the tube positions for different types of tubes Note If the sample to be analyzed is a capillary or prediluted sample, be sure to uncap the tube before analysis.

1-5

Using This Manual

Figure 1-1 Tube position instruction label and uncapping tube reminder for capillary or prediluted samples (only for closed-sampling models)

Applicable to closed-sampling models Indicate the tube positions for different types of tubes Notes: If the sample to be analyzed is a capillary or prediluted sample, be sure to uncap the tube before analysis.

1-6

Using This Manual

Figure 1-2 Hand-pricking warning sign (Open-sampling types)

① Applicable to open-sampling type analyzers Warning The probe is sharp and may contain biological contaminants. Be careful when operating it!

1-7

Using This Manual

Figure 1-3 Bio-hazard warning sign at waste outlet and power warning label (all models)

① Warning 1. Connect only to a properly grounded outlet. 2. To avoid electrical shock, disconnect power prior to maintenance. 3. To prevent fire, only use the fuse of specified type and current rating.

② BIOLOGICAL RISK Biological risk

1-8

Using This Manual

Figure 1-4 Moving parts warning sign (both models)

Warning To avoid personal injury, do not put your hand under the syringe or inside the slot!

1-9

Using This Manual

Figure 1-5 Note and warning signs on autoloader (for all models)

① Note 1

Slide the tube into the tube rack. If it was not feasible, replace the tube barcode.

2

Make sure the tube cap is secured.

3

Make sure the unloading tray is not full and the detecting sensor is not covered, and then start analysis.

② BIOLOGICAL RISK Biological risk

1-10

Using This Manual

Figure 1-6 Optical assembly laser warning sign (for all models)

① Caution: Class 3B laser radiation when open and internal locks defeated Avoid exposure to the laser beam

1-11

Using This Manual

1.4 Safety Information You will find the following symbols in this manual: When you see...

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

WARNING

alerting you to an operating hazard that can cause personnel injury. Read the statement below the symbol. The statement is

CAUTION

alerting you to a possibility of system damage or unreliable analysis results.

Safety precautions: For the safety of patients and operators, be sure to follow the precautions below during the installation.

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 injury of human health.



Check the equipment state after repair. Make sure the equipment is safe before offering it to users.



Move and install the analyzer with a special-purpose tool (for example, a carrying handle).



Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol) around the analyzer. Otherwise, the risk of explosion may exist.



Contacting exposed electronic components while the equipment is attached to power can cause personal injury from electric shock or damage to electronic components. Power down before removing covers to access electronic components.



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

1-12

Using This Manual



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



Possible mechanical movement of the warned position may lead to personal injury during normal operation, removal and maintenance.



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



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



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



Before maintaining, transporting or servicing the instrument, clean and sterilize the instrument cover as well as the parts and components with biological risks (such as the sample probe). Remind the persons who handle the instrument of the related risks.



After maintenance, be sure to check the system status and confirm that it is safe before delivering it to the user.

CAUTION 

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



For problems not mentioned in this manual, contact Mindray customer service department for service advice.



To prevent personal injury or damage to equipment components, remove metal jewelry before maintaining or servicing electronic components of the equipment.



Electrostatic discharge may damage electronic components. If there is a possibility of ESD damage during servicing, then work at an ESD workstation, or wear an antistatic wrist strap while servicing the system.

1-13

Using This Manual

NOTE 

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, so take proper protective measures for operation and maintenance.



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

Laser warning CLASS 1 LASER PRODUCT

Caution: Class 3B laser radiation when open and internal locks defeated Please avoid the laser beam

Warning Laser radiation Please avoid the laser beam CLASS 3B LASER PRODUCT Max. Output 10mW Wavelength 635nm Standard: GB7247.1-2012 Issue date: Dec. 31, 2012

1-14

Using This Manual

1.5 Term Definition This series of analyzers have two sampling types: open-sampling and closed-sampling. 

Open-sampling type analyzers

The user manually places a vacuum tube with a blood sample or an open lid under an open sampling probe, and presses the [Aspirate] button to aspirate the blood sample. Those models using the open-sampling mode are called Open-sampling types 

Closed-sampling type analyzers

In this mode, closed-sampling devices are used to perform closed-cover piercing. Those models using the closed-sampling mode are called closed-sampling models

1-15

Chapter 2 System Introduction 2.1 Intended Use The Auto Hematology Analyzer is a quantitative, automated hematology analyzer for In Vitro Diagnostic Use in clinical laboratories; it provides Complete Blood Count, Leukocyte 5-part Differential, Hemoglobin Concentration Measurement, Reticulocyte Count, Nucleated Red Blood Cell Measurement, and Body Fluid Cell Count.

NOTE 

The subtypes of body fluid supported by the analyzer include cerebrospinal fluid, serous cavity fluid (pleural fluid and ascitic fluid) and synovial fluid samples. You may not get accurate results if you analyze body fluid samples other than specified above.



BC-6000Plus/BC-6100Plus/BC-6200 supports the RET test. BC-6000/BC6100 does not support the RET test.

2-1

System Introduction

2.2 Parameters NOTE 

The analyzer identifies the normal patient, with all normal systemgenerated parameters for In Vitro Diagnostic Use. The product flags or identifies patient results that require additional studies.

It outputs the following test parameters in blood sample analysis: Table 2-1 Blood Sample Test Report Parameters Series

English name

Abbreviation

WBC series (13) RET series (7)

White Blood Cell count

WBC

Basophils number

Bas#

Basophils percentage

Bas%

Neutrophils number

Neu#

Neutrophils percentage

Neu%

Eosinophils number

Eos#

Eosinophils percentage

Eos%

Lymphocytes number

Lym#

Lymphocytes percentage

Lym%

Monocytes number

Mon#

Monocytes percentage

Mon%

Immature Granulocyte number

IMG#

Immature Granulocyte percentage

IMG%

Reticulocyte percentage

*RET%

Reticulocyte number

*RET%

RBC

group (10)

Reticulocyte Hemoglobin Expression

RHE

Immature reticulocyte fraction

*IRF

Low fluorescent ratio

*LFR

Middle fluorescent ratio

*MFR

High fluorescent ratio

*HFR

Red Blood Cell count

RBC

Hemoglobin Concentration

HGB

Mean Corpuscular Volume

MCV 2-2

System Introduction

MCH

Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration

MCHC

Red Blood Cell Distribution Width - Coefficient of Variation

RDW-CV

Red Blood Cell Distribution Width - Standard Deviation

RDW-SD HCT

Hematocrit Nucleated red blood cell number

NRBC#

Nucleated red blood cell percentage

NRBC%

Platelet series (7)

Platelet count

PLT

Mean Platelet Volume

MPV

Platelet Distribution Width

PDW

Plateletcrit

PCT

Immature Platelet Fraction

IPF

Platelet-large cell ratio

P-LCR

Platelet-large cell count

P-LCC

Table 2-2 Blood Sample Test Research Use Only (RUO) Parameters English name

Abbreviation

High fluorescent Cell number

HFC#

High fluorescent Cell percentage

HFC%

Optical Red Blood Cell count

RBC-O

Optical Platelet count

PLT-O

Platelet count- Impedance

PLT-I

Optical white blood cell count

WBC-O

White blood cell count –DIFF

WBC-D

Total nucleated cell counts-DIFF

TNC-D

Immature eosinophil percentage

IME%

Immature eosinophil number

IME#

High forward scatter NRBC ratio

H-NR%

Low forward scatter NRBC ratio

L-NR%

Neutrophil-to-lymphocyte ratio

NLR

Platelet-to-lymphocyte ratio

PLR

White blood cell count-WNB

WBC-N

Total nucleated cell counts-NRBC

TNC-N

Infected Red Blood Cell count

InR#

Infected Red Blood Cell permillage

InR‰ 2-3

System Introduction

Microcyte count

Micro#

Microcyte percentage

Micro%

Microcyte count

Macro#

Macrocyte percentage

Macro% MRV

Mean Reticulocyte Volume

PDW-SD

Platelet Distribution Width Standard Deviation

RPI

Reticulocyte Production Index High Fluorescent Immature Platelet Fraction

H-IPF

Immature Platelet Count

IPF#

RBC Fragment Count

FRC#

RBC Fragment Percentage

FRC%

Table 2-3 Blood Sample Test Histograms RBC Histogram

RBC Histogram

PLT Histogram

PLT Histogram Table 2-4 Blood Sample Test Scattergrams

DIFF Scattergram

DIFF Scattergram

WNB Scattergram

WNB Scattergram

*RET Scattergram

RET Scattergram

*PLT-O Scattergram

PLT-O Scattergram

*RET-EXT Scattergram

RET-EXT Scattergram Table 2-5 Blood Sample Test-Test Panels

Throughput (samples/hour)

Sample Volume (ul)

WB

WB

Capillary

PD

Blood

Capillary

PD

Blood

CBC

110

71

71

64.5

30

83

CBC+ DIFF

110

71

71

64.5

30

83

*CBC+DIFF+RET

65

49

46

64.5

30

83

*CBC+ RET

65

49

46

64.5

30

83

*RET

65

49

46

64.5

30

83

Note: The items with * only apply to BC-6000Plus, BC-6100Plus and BC-6200. The analyzer outputs the following test parameters in body fluid sample analysis:

2-4

System Introduction

Table 2-6 Body fluid sample test report parameters Series

English name

Abbreviation

WBC series (6)

White Blood Cell count-body fluid

WBC-BF

Total nucleated cell counts-body fluid

TC-BF#

Mononuclear cell number

MN#

Mononuclear cell percentage

MN%

Polymorphonuclear cell number

PMN#

Polymorphonuclear cell percentage

PMN%

(1) RBC

Red Blood Cell count-body fluid

RBC-BF

series Table 2-7 Body Fluid Sample Test Research Use Only (RUO) Parameters English name

Abbreviation

Eosinophils number- body fluid

Eos-BF#

Eosinophils percentage- body fluid

Eos-BF%

Neutrophils number- body fluid

Neu-BF#

Neutrophils percentage- body fluid

Neu-BF%

Lymphocytes number- body fluid

LY-BF#

Lymphocytes percentage- body fluid

LY-BF%

Monocytes number- body fluid

MO-BF#

Monocytes percentage- body fluid

MO-BF%

High fluorescent cell number- body fluid

HF-BF#

High fluorescent cell percentage- body fluid

HF-BF%

Red Blood Cell count-body fluid

RBC-BF

Note: The report parameter RBC-BF shows 3 decimal places; while the RUO parameter RBCBF shows 4 decimal places. Table 2-8 Body Fluid Sample Test Histograms RBC Histogram

2-5

System Introduction

Table 2-9 Body Fluid Sample Test Scattergrams DIFF Scattergram Table 2-10 Body Fluid Sample Test-Test Panels Body fluid analysis mode

2-6



System Introduction

2.3 Product Description 2.3.1 Product Structure and Components The analyzer consists of the sample processing unit, data management unit, result output unit and accessories.

2.3.2 Modules and Components

WARNING 

Do not use anything sharp on the touch screen or strike on it.



Clean the touch screen with clean and soft cloth, as well as neutral cleanser or ethanol rather than chemical solution, acid or alkali solution.

Figure 2-1 Front side of BC-6000/BC-6000Plus/BC-6100/BC-6200Plus Open-sampling type

2-7

System Introduction

Figure 2-2 Front side of BC-6200, Open-sampling type

①

① ---- Touch screen

② ---- Status indicator

③ ---- Aspirate key

④ ---- Sample probe

⑤ ---- Autoloader

⑥ ---- Fluorescent dye compartment

⑦ ---- Count Key

⑧ ---- Mode switch key

Touch screen

The touch screen displays all alphanumeric and graphic data. You can use it to operate your analyzer

②

Status Indicator

The status indicator located under the touch

Ready: indicator

screen tells you about the status of the

stays in green

instrument including ready, running, error,

Running: indicator

standby and on/off, etc.

flickers in green Error: indicator stays in red standby: indicator stays in orange Off: indicator off Sample probe is lowering down: quickly flickers

③

Aspirate key

The [Aspirate] key is located behind the sample probe. Press the key to start analysis 2-8

/

System Introduction

or add diluent ④

Sample probe

The sample probe aspirates samples and

/

adds diluent ⑤

Autoloader

The autoloader is in the front of the analyzer.

/

You can use it to load tubes automatically. ⑥ ⑦

Fluorescent dye

Open the fluorescent dye compartment to

compartment

replace the fluorescent dyes

[Run] Key

When running samples under autoloading

/ /

mode, press the [Run] key to start analysis ⑧

Mode switch key

Press the mode switch key to quickly switch between the autoloading mode and the opensampling mode

2-9

/

System Introduction

Figure 2-3 Front side of BC-6000/BC-6000Plus/BC-6100/BC-6200Plus closed-sampling model

Figure 2-4 Front side of BC-6200 closed-sampling model

2-10

System Introduction

① ---- Touch screen

② ---- Fluorescent dye compartment

③ ----Autoloader

④ ---- Sample compartment

⑤ ---- Status indicator

⑥ ---- Count Key

⑦ ---- Mode switch key ①

Touch screen

The touch screen displays all alphanumeric and graphic data. You can use it to operate your analyzer

②

Status indicator

The status indicator located under

Ready: indicator stays in green

the touch screen tells you about

Running: indicator flickers in

the status of the instrument

green

including ready, running, error,

Error: indicator stays in red

standby and on/off, etc.

Sleep: indicator stays in orange Off: indicator off

③

Aspirate key

The [Aspirate] key is behind the sample probe. Press the key to start analysis or add diluent

④

Sample probe

The sample probe aspirates samples and adds diluent

⑤

Autoloader

The autoloader is in the front of the analyzer. You can use it to load tubes automatically.

⑥

Fluorescent dye

Open the fluorescent dye

compartment

compartment to replace the fluorescent dyes

⑧[Run] Key ⑧

Mode switch key

Press the key to start analysis Press the mode switch key to quickly switch between the autoloading mode and closedsampling mode

2-11

System Introduction

Figure 2-5 Back of the analyzer (both types) ① ---- Network interface

② ---- AC input

③ ---- M-6LH Lyse inlet

④ ---- M-6LN Lyse inlet

⑤ ---- M-6LD Lyse inlet

⑥ ---- M-6DR Diluent inlet

⑦ ---- DS Diluent inlet

⑧ ---- Waste outlet

2-12

System Introduction

Figure 2-6 Right side of the analyzer (both types) ① ---- USB ports

② ---- Power switch

Figure 2-7 Closed-sampling type (front cover open)

2-13

System Introduction

Figure 2-8 Open-sampling type (front cover open)

Figure 2-9 Both types (right side cover open)

2-14

System Introduction

Figure 2-10 Both types (left side cover open)

2.3.3 Accessories List of the Analyzer The configured and optional accessory list of the analyzer is shown below. Table 2-11 Configured and optional accessory list Configured Tube racks



Reagent cap assembly



Waste tube assembly



Main power cords



Optional

External barcode scanner



Autoloader Built-in barcode



scanner Printer



Sample transportation track



For any questions about the configured/optional accessories, consult your sales representative.

2-15

System Introduction

2.3.4 Tubes and Tube Racks Tube types supported by closed-sampling type analyzers Table 2-12 Tube types supported by closed-sampling type analyzers Mode

Tube types

Sample setting

Cap open?

positions Autoloading mode

Evacuated

blood

Tube racks

Capped

collection tube BD micro tube

Tube racks

Capped

Syringe tubes

Tube racks

Capped

CT-WB

Evacuated

(closed-sampling

collection tube

blood

WB tube position

Either

closed

PD/Micro-WB tube

Uncapped

type) CT-Micro-WB

Small

(closed-sampling

anticoagulated tube

type)

1.5ml centrifugal tube

position PD/Micro-WB tube

Uncapped

position 0.5ml centrifugal tube

PD/Micro-WB tube

Uncapped

position CT-PD

Small

(closed-sampling

anticoagulated tube

closed

type)

1.5ml centrifugal tube

PD/Micro-WB tube

Uncapped

position PD/Micro-WB tube

Uncapped

position CT-BF

Evacuated

blood

WB tube position

Either

(closed-sampling

collection tube

type)

Uncapped

hard/soft

WB tube position

Uncapped

tubes

WARNING 

Do not use BD micro tubes or syringe tubes to run samples in closed-tube mode.



Uncap the tube before capillary or prediluted sample analysis.

2-16

System Introduction

Recommended tube types used with open-sampling type analyzers Table 2-13 Recommended tube types used with open-sampling type analyzers Mode

Tube types

Sample setting

Cap open?

positions Autoloading mode

Evacuated blood

Tube racks

Capped

BD micro tube

Tube racks

Capped

Syringe tubes

Tube racks

Capped

collection tube

In the open-sampling mode, after removing the tube cap, make sure the tube length is within 85mm.

CAUTION 

Uncap the tube before capillary or prediluted sample analysis.

Use BD micro tubes and syringe tubes under autoloading mode If you are going to run samples collected with BD micro tubes and syringe tubes in autoloading mode, use tube racks specially made for the micro tubes and syringe tubes. The tube racks for BD micro tubes and syringe tubes have colored adapters installed at every tube position.

Figure 2-11 Special tube racks made for BD micro tubes and syringe tubes ① Colored adapters

2-17

System Introduction

2.4 Overview of Software Interfaces 2

1

3

4

5

① Menu Tap the

button at the top left of the software screen to display the system menu.

Below describes the software menu functions of the analyzer. Menu Level No. 1. 2.

Level 1

Level 2

Count

/

Table

/

Level 3

Review QC

L-J QC

Setup Count

3.

X-B QC

Setup Graph

Calibration

Manual Calibrator

4.

Fresh Blood CBC Gain Calibration Optical Gain Calibration

2-18

System Introduction

Calibration History Status

Statistics Temp.&Pressure Floater Status

5.

Sensor Voltage & Current Version Info. Setup

Print Setup Communication Barcode Date/Time Setup Lab Info. Setup System Setup

Signal Para. Flag Alarm Sensitivity Flag Rules Setup Alg-adjusted factors Tube Rack Type Setup Re-exam Setup

User Management 6.

Auxiliary Setup Parameter Unit Setup Reference Range Setup Para. Setup

RUO Para. Setup Microscopic Para. Setup

Maintenance Reagent Setup Auto-loading Gain Setup Re-exam Rules Setup Auto Startup/Shutdown Service

Adj. Sample Probe Pos. Adjust Autoload Pos.

7.

Debug & Self-Test

Self-Test Heating Debug Pressure Debug

2-19

System Introduction

Laser Diode Debug Sensor Debug Optical Debug

Maintenance Screen Cal. Log Advanced Toolbox 8.

Logout

/

9.

Shutdown

/

② Utility button area Name

Icon

Function

Count

Tap to enter the "Count" screen

Table

Tap to enter the "Table Review" screen

Review QC

Tap to enter the "QC" screen When the "QC" button lighted in orange, it means the analyzer is out of quality control

Reagent

Tap to enter the "Reagent Setup" screen, check

Setup

or set the remaining reagent value and expiration date, and replace the reagent; When the "Reagent Setup" button lights in orange, it means some reagent is expired or not sufficient

Diluent

When the analyzer switches to the Predilute (PD) analysis mode, tap "DILUENT" to dispense diluent

print



When the analyzer is on the "Count" screen, tap the "Print" button to print the analysis results, histograms and scattergrams of the current sample in accordance with operatorcustomized print template



When the analyzer is on the "Table Review" 2-20

System Introduction

screen, tap the "Print" button to print the analysis results for all or selected samples in the table print or graph print form 

When the analyzer is on the "Graph Review" screen, tap the "Print" button to print the analysis

results,

histograms

and

scattergrams of the current sample in accordance with operator-customized print template 

When the analyzer is on the "QC Table" screen, tap the "Print" button to print all QC results included in the selected QC file



When the analyzer is on the "QC Graph" screen, tap the "Print" button to print the QC graphs included in the selected QC file



When the analyzer is on the "Manual" screen, tap "Print" to print the manual calibration factors

③ Operation area It displays the contents of the corresponding screen. For example, on the "Count" screen, the area displays the corresponding keys for count operations and count results. ④ Auxiliary information area It displays the auxiliary information related to the current screen. For example, on the "Count" screen, the area displays the ID and analysis mode of the next sample; on the "Table Review" or "Graph Review" screen, the area displays the position and total number of the current sample. ⑤ Other information It displays the current system time; When error occurs, the area displays the error message.

2-21

System Introduction

2.5 Reagents, Controls and Calibrators As the analyzer, reagents, controls and calibrators are components of a system, performance of the system depends on the combined integrity of all components. Users must use the specified reagents (see the Specifications in the Appendix B), which are formulated specifically for the fluidic system of your analyzer in order to provide optimal system performance. Do not use the analyzer with reagents from multiple suppliers. In such use, the analyzer may not meet the performance specified in this manual and may provide unreliable results. All references related to reagents in this manual refer to the reagents specifically formulated for this analyzer.

CAUTION 

Each reagent package must be examined before use. Product integrity may be compromised in packages that have been damaged. Inspect the package for signs of leakage or moisture. If there is evidence of leakage or improper handling, do not use the reagent.



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



When you have changed the diluent, lyse or cleanser, run a background to see if the results meet the requirement.



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



After installing a new container of reagent, keep it still for a while before use.

2.5.1 Reagents 

DS DILUENT

The DS DILUENT participates in the measurement of parameters related to RBC, PLT, WBC, RET and NRBC. This product participates in cell differentiation, counting and HGB measurement which are accomplished by using the impedance method, colorimetric method and SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals). 

M-6DR DILUENT

The M-6DR DILUENT participates in the measurement of RET-related parameters together with M-6FR DYE. 2-22

System Introduction

This product is formulated to lyse red blood cells in blood cell measurement, facilitate the dyeing effect of reticulocytes by M-6FR DYE. It participates in the measurement of RET-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals). 

M-6LD LYSE

The M-6LD LYSE participates in WBC differentiation in the DIFF channel together with M-6FD DYE. This product is formulated to lyse red blood cells and process white blood cells in the blood cell measurement, amplify the differences among WBC sub-populations and facilitate the dyeing effect of white blood cells by M-6FD DYE. It participates in the measurement of WBC-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals). 

M-6LH LYSE

The M-6LH LYSE is formulated to measure the hemoglobin-related parameters. This product is formulated to lyse red blood cells, release hemoglobin in red blood cells and transform it into methemoglobin, which enables the measurement of hemoglobin-related parameters by using the colorimetric method. 

LM-6LN LYSE

This product participates in the measurement of NRBC-related parameters together with M6FN DYE. This product is formulated to lyse red blood cells in blood cell measurement, facilitate the dying effect of NRBCs by M-6FN DYE. It participates in the measurement of NRBC-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals). 

M-6FD DYE

The M-6FD DYE participates in WBC differentiation in the DIFF channel together with M-6LD LYSE. This product is formulated to dye the white blood cells with the assist of M-6LD LYSE. It participates in the measurement of WBC-related parameters in the DIFF channel which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals). 

M-6FR DYE

The M-6FR DYE participates in the measurement of RET-related parameters together with M6DR DILUENT. This product is formulated to dye reticulocytes with the assist of M-6DR DILUENT. It participates in the measurement of RET-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and 2-23

System Introduction

fluorescence signals). 

M-6FN DYE

The M-6FN DYE is formulated to dye blood cells, for observing their morphology and structure and facilitating the cell differentiation and counting. During blood cell measurement, the M-6FN DYE is formulated to dye NRBCs with the assistance of the M-6LN LYSE, and perform NRBC measurement by combining laser scattering and SF Cube cell analysis techniques. 

Probe Cleanser

The probe cleaner is formulated to clean the analyzer on a regular basis; it is a cleaning solution containing sodium hypochlorite, which can clean the measurement channels and pipelines and remove blood proteins. *Note: *M-6FR DYE and M-6DR DILUENT are only applicable to BC-6000Plus, BC-6100Plus and BC-6200 models.

2.5.2 Controls and Calibrators The controls and calibrators are used to verify the accurate operation and calibrate the analyzer. The controls are industrially prepared whole-blood products used to monitor and evaluate the analysis precision of the Hematology Analyzer. The controls are prepared with three levels, namely low, normal and high. Daily use of all levels verifies the operation of the analyzer and ensures reliable results are obtained. The calibrators are also industrially prepared whole-blood products, specifically manufactured for the calibration of WBC, RBC, HGB, MCV, PLT and other parameters of the Hematology Analyzer, so as to build the metrological traceability of analysis results. For the use and storage of controls and calibrators, please refer to the Instruction for Use of each product. All references related to "controls" and "calibrators" in this manual refer to the controls and calibrators specifically formulated for this analyzer by Mindray. You must buy those controls and calibrators from Mindray or Mindray-authorized distributors. There are 3 types of controls used with the analyzer: Table 2-14 Controls Name BR60

Hematology

Model BR60

Control BC-6D

Levels "High", "Low",

Type

QC Parameters

Others

All report parameters1*

Mindray

All

"Normal" Hematology

BC-6D

Controls

"High", "Low", "Normal"

report

parameters

except RET group parameters2*

BC-RET Hematology Controls

BC-RET

"High", "Low",

Mindray

RET group parameters4*

"Normal"

Note: 1.

The specific measurement parameters and reference values are available in the control reference

2-24

System Introduction value table; 2.

The specific measurement parameters and reference values are available in the control reference value table;

3.

Only applicable to BC-6000Plus, BC-6100Plus and BC-6200. The specific measurement parameters and reference values are available in the control reference value table.

The calibrators used with the analyzer: Table 2-15 Calibrators Name

Model

SC-CAL PLUS Hematology Calibrator

SC-CAL PLUS

2-25

Chapter 3 System Principles 3.1 Overview The principles used by the analyzer for measurement are: impedance method and SF Cube cell analysis technology for cell differentiation and counting; colorimetric method for hemoglobin measurement.

3-1

System Principles

3.2 WBC Measurement 3.2.1 SF CUBE Cell Analysis Technology In normal peripheral blood, white blood cells can be classified into 5 categories: lymphocytes, monocytes, neutrophils, eosinophils and basophils. Analyzing all types of white blood cells will provide a great deal of useful information for the clinical diagnosis of diseases. Under the influence of certain diseases, the peripheral blood may contain various abnormal cells apart from the five subpopulations of normal cells, such as atypical lymphocytes, immature cells, etc. Most of these abnormal cells are different kinds of immature cells in the cell generation process. But what they have in common is they contain a great deal of nucleic acid (DNA and RNA), the content of which decreases as the cell gets maturer. Therefore, normal cells and immature cells can be differentiated by detecting the content of nucleic acid in the cells. Body fluid refers to the fluid in side body cavities except blood vessels. There are many subtypes of body fluid, among which the most commonly seen sub-types are cerebrospinal fluid and serous cavity fluid. Both cerebrospinal fluid and serous cavity fluid are colorless and transparent in normal case, but in abnormal cases, there could be increase of cells (including leukocytes and erythrocytes). Leukocytes in body fluid can be categorized into mononuclear cells (MN) and polymorphonuclear cells (PMN). The analysis of the cells in body fluid can provide useful information for clinical diagnosis. The analyzer adopts the SF Cube cell analysis technology to recognize and detect the immature cells in blood accurately based on doing WBC 5-part differentiation, as well as identify the nucleated cells in body fluid.

Fluorescence

Light

RNA/DNA content

Side scatter

splitter

Internal cell structure

Laser beam Forward scatter Cell volume

Figure 3-1 SF Cube Technology The analyzer adopts the SF Cube cell analysis technology in its DIFF and WNB channels. The RBCs are lysed and the WBC subpopulations are made different in size and complexity by the lyse; the nucleic acid substances in WBCs are marked by the new asymmetric cyanine 3-2

System Principles

fluorescent substance. Due to the different content of nucleic acid in different WBC subpopulations, maturity stages or abnormal development status, the volume of fluorescent dye staining the nucleic acid substances can be different; the low-angle light scatter reflects cell size, the high-angle light scatter reflects intracellular granularity, and the intensity of fluorescent signal reflects the degree that the cell is stained. By sensing the difference in signal in three dimensions of the cells processed with lyse, the DIFF channel differentiates the subpopulations of WBCs (lymphocytes, monocytes, neutrophil and eosinophils), as well as identifies and flags abnormal cells like immature granulocytes, abnormal lymphocytes and blast cells. In the meanwhile, the WNB channel differentiates basophils and nucleated red blood cells and counts the WBCs. The lymphocytes are smaller in size with the nucleus taking most part of them. Lymphocytes have a high nucleus-to-cytoplasm ratio, but their nucleic acid content is low, therefore they are at a lower position in the direction of fluorescence and side scatter. The monocytes are larger in size, with high nucleus-to-cytoplasm ratio and high nucleic acid content, and less complex in structure, therefore they are at a higher position in the direction of fluorescence, and have stronger side scatter. The neutrophils and basophils are larger in size, and have medium nucleus-to-cytoplasm ratio and low nucleic acid content, therefore they are at a lower position in the direction of fluorescence, but they have stronger side scatter. The characteristics of the eosinophils are similar to those of the neutrophils, but they contain a lot of alkaline grains, so they have very strong side scatter. The blast cells, atypical lymphocytes and immature granulocytes have high nucleic acid content, so they are at a higher position in the direction of fluorescence on the scattergram. In body fluid samples, the mononuclear cells (MN) are less complex in intracellular granularity, so the side scatter is weaker, while polymorphonuclear cells are more complex in intracellular granularity, so the side scatter is stronger.

3.2.2 WBC-Related Parameters WNB Scattergram 1. WBC area 2. Bas area 3. Achromatocyte area 4. NRBC area

3-3

System Principles

WNB Scattergram 5. WBC area 6. Bas area 7. Achromatocyte area 8. NRBC area

Parameters WBC

Item

Formula/Test Methods

Unit 109/

White

WBC

blood cell

= Sum of all particles in the WBC reagion in the WNB channel L

count Bas# Bas%

109/

Basophils

Bas#

number

L = Sum of all particles in the Bas reagion in the WNB channel

Basophils percentag

Bas% =

Bas# × 100% WBC

%

e Lym%

Lymphoc ytes percentag

%

Lym% =

e

Particles in the Lym region in the DIFF channel Sum of all particles in DIFF channel except those in Ghost region

× 100%

Neu%

Neutrophi ls percentag

%

Neu% =

e

Particles in the Neu region in the DIFF channel Sum of all particles in DIFF channel except those in Ghost region

× 100%

Mon%

Monocyte s percentag

%

Mon% =

e

Particles in the Mon region in the DIFF channel Sum of all particles in DIFF channel except those in Ghost region

× 100%

Eos%

Eosinophi ls percentag e

%

Eos% =

Particles in the Eos region in the DIFF channel Sum of all particles in DIFF channel except those in Ghost region

× 100%

3-4

System Principles

IMG%

Immature Granuloc yte percentag

Lym#

%

IMG% =

Particles in the IMG region in the DIFF channel Sum of all particles in DIFF channel except those in Ghost region

e

× 100%

Lymphoc

Lym# = WBC × Lym%

ytes

109/ L

number Neu#

Neutrophi

Neu# = WBC × Neu%

ls number Mon#

Monocyte

L Mon# = WBC × Mon%

s number Eos#

Eosinophi Immature

109/ L

Eos# = WBC × Eos%

ls number IMG#

109/

109/ L

IMG# = WBC × IMG%

Granuloc

109/ L

yte number

3-5

System Principles

3.3 Derivation of NRBC-Related Parameters Parameters NRBC%

Item

Formula/Test Methods

Nucleated Red Blood

Cell

percentage

Unit %

NRBC% Particles in the NRBC region of the WNB channel = Sum of all particles in the WBC region of the WNB channel × 100%

NRBC#

Nucleated Red

NRBC#=Sum of all particles in the NRBC region of

Blood

the WNB channel

Cell

count

3-6

109/L

System Principles

3.4 Hemoglobin Concentration Measurement 3.4.1 A Test Model Using the Colorimetric Method

Figure 3-2 Colorimetric Method According to the Lambert-Beer Principle, when a beam of monochromatic light passes through a well-proportioned non-scattering light-absorbing solution, the absorbance A is proportional to the product of the thickness L and the concentration C. The sample in the HGB channel acts as the light absorbing substance after being treated by reagent, therefore the HGB concentration can be measured by measuring the absorbance.

3.4.2 HGB Measurement The Hemoglobin Concentration (HGB) is calculated per the following equation and expressed in g/L. Parameters HGB

Item

Formula/Test Methods

Hemoglobin

HGB

Concentration

Blank Photocurrent = Constant × Ln( ) Sample Photocurrent

Unit g/L

3-7

System Principles

3.5 RBC/PLT Measurement 3.5.1 Impedance Method RBCs/PLTs are counted by the Electrical Impedance method. The aspirated sample enters the RBC metering unit after two times of dilution. The little opening on the metering unit is called "aperture". A pair of electrodes is positioned on both sides of the aperture to create a constantcurrent supply. As cells are poor conductors, when each particle in the diluted sample passes through the aperture under the constant negative pressure, a transitory change in the directcurrent resistance between the electrodes is produced. The change in turn produces a measurable electrical pulse signal which is proportional to the particle size at both ends of the electrodes. And when the particles pass the aperture in succession, a series of pulses are produced between the electrodes. The number of pulses generated indicates the number of particles passed through the aperture; and the amplitude of each pulse is proportional to the volume of each particle.

Figure 3-3 Metering diagram Each pulse is amplified and compared to the internal reference voltage channel, which only accepts the pulses of a certain amplitude. All the collected pulses are thus classified based on the reference voltage thresholds of different channels, and the number of the pluses in the RBC/PLT channel indicates the number of the RBC/PLT particles. The number of cells in each channel range divided according to the pulse voltage amplitude determines the cell volume distribution. The 2-dimensional distribution diagram (scattergram), with the X-axis representing cell volume, and Y-axis representing relative cell numbers, shows the distribution of cell population.

3-8

System Principles

3.5.2 SF CUBE Cell Analysis Technology The RET channel also adopts the SF CUBE Cell Analysis Technology. The general measurement principle in RET channel is similar to that of WNB and DIFF channels, only that in the RET channel, the RBCs are not lysed, but are spherized by RET diluent. Then the nucleic acid of the spherized RBCs and the PLTs are stained by fluorescent dyes.

3.5.3 RBC-Related Parameters Parameters RBC

Item

Formula/Test Methods

Red Blood Cell count

Unit

The analyzer provides the number of red blood cells (RBC) directly by counting the red blood cells passing through the aperture.

MCV

Mean

Corpuscular

Volume

fL

histogram

HCT

Hematocrit

MCH

Mean

Corpuscular

Hemoglobin MCHC

Calculated based on the red blood cell

Mean

Corpuscular

Hemoglobin

HCT =

RBC × MCV 10

％

MCH =

HGB RBC

pg

MCHC =

HGB × 100 HCT

g/L

Concentration RDW-CV

Red

Blood

Distribution

Cells

Width

RBC Histogram

%

Standard deviation of RBC distribution

fL

-

Coefficient of Variation RDW-SD

Red

Blood

Distribution

Cells

Width

-

Standard Deviation

3.5.4 PLT-Related Parameters Parameters

Item

Formula/Test Methods

PLT

Platelet

Platelet number (PLT) is measured directly by

count

counting the platelets passing through the

Unit 109/L

aperture. MPV

Mean

Mean Platelet Volume (MPV) is calculated based

Platelet

on the PLT histogram.

fL

Volume PDW

PCT

Platelet

Platelet distribution width is derived from the

Distribution

platelet histogram, and is reported as 10

Width

geometric standard deviation (10 GSD)

Plateletcrit

PCT =

PLT×MPV 10000 3-9

/

％

System Principles

P-LCR1*

Plateletlarge

P-LCC

P-LCR is derived from the platelet histogram, it cell

%

represents the ratio of the number of platelets

ratio

with a size over 12fL to the total platelets number.

Platelet-

P − LCC = PLT × P − LCR

109/L

Immature

Derived based on PLT-O scattergram:

%

Platelet

IPF

large

cell

count IPF

、

Fraction

=

Immature platelet number in the optical channel Sum of all platelet particles in the optical channel

× 100%

Note: 1. Platelet-Large Cell Ratio (P-LCR) is derived from the platelet histogram; it represents the ratio of the number of platelets with a size over 12fL to the total platelets number. The ratio is represented in %. In the following figure, S2 represents the number of larger platelet cells, and S1+S2 represents the total PLT count.

2. Only applicable to BC-6000Plus, BC-6100Plus and BC-6200.

3.5.5 Reticulocyte Parameters Parameters *RET%

Name Reticulocy

Formula/Test Methods RET%

te percentag e

=

Unit ％

Number of cells in the reticulocyte region Number of cells in mature RBC region + Number of cells in RET region

× 100% RET#

RET# = RBC × RET%

Reticulocy te number

*HFR

High Fluoresce

1012/ L

HFR =

Number of cells in HFR region × 100% Number of cells in RET region

nt Reticulocy 3-10

％

System Principles

te Ratio *MFR

Middle Fluoresce

MFR =

Number of cells in MFR region × 100% Number of cells in RET region

％

nt Reticulocy te Ratio *LFR

LFR = 100 − HFR − MFR

％

IRF = MFR + HFR

%

Reticulocy

Calculated based on the light scatter information of

pg

te

RET

Low Fluoresce nt Reticulocy te Ratio

*IRF

Immature Reticulocy te Fraction

RHE

Hemoglobi n Expressio n *Note: The RET parameters are only applicable to BC-6000Plus, BC-6100Plus and BC-6200.

3-11

System Principles

3.6 Body Fluid Parameters Body fluid refers to the fluid in side body cavities except blood vessels. There are many subtypes of body fluid, among which the most commonly seen sub-types are cerebrospinal fluid and serous cavity fluid. Both cerebrospinal fluid and serous cavity fluid are colorless and transparent in normal case, but in abnormal cases, there could be increase of cells (including leukocytes and erythrocytes). Leukocytes in body fluid can be categorized into mononuclear cells (MN) and polymorphonuclear cells (PMN). The analysis of the cells in body fluid can provide useful information for clinical diagnosis. Parameters WBC-BF

Item White

Formula/Test Methods Blood

Cell count-body

WBC − BF

MN%

109/L

= The sum of all particles in DIFF channel except Those in ghost region and HFR region

fluid TC-BF#

Unit

109/L

Total nucleated

TC − BF

cell counts-body

= The sum of all particles in Diff channel except

fluid

those in ghost region

Mononuclear

MN%

cell percentage

=

％

Particles in MN reagion of DIFF channel WBC − BF

× 100% PMN%

Polymorphonucl ear

cell

percentage

PMN% =

％

Particles in PMN reagion of DIFF channel WBC − BF

× 100% MN#

MN# = WBC − BF × MN%

109/L

PMN# = WBC − BF × PMN%

109/L

Red Blood Cell

The analyzer provides the number of red blood

1012/

count-body fluid

cells in body fluid (RBC-BF) directly by counting

L

Mononuclear cell number

PMN#

Polymorphonucl ear cell number

RBC-BF

the red blood cells passing through the aperture.

3-12

System Principles

3.7 Flush After each analysis cycle, all elements of the analyzer that the sample runs through are washed to ensure no residue is left.

3-13

Chapter 4 Software System 4.1 Login Password Service level User ID: Service Password: Se s700 (note there is a space between Se and s700). Administrator level user ID: Admin Password: Admin

NOTE 

Password is case sensitive.

4.1.1 System Self-test When Logging in at Service Access Level When you log in at service access level, the analyzer will automatically run a check matching the backup data on the board card with the data in the SSD hard disk. If the board card or SSD hard disk has been replaced before, or the analyzer detects the configuration change before the abnormal shutdown, you will be prompted to restore the system or back up data. Tap "OK" to enter the backup and restoration screen, follow the prompts to complete the data backup or restoration: When the SSD hard disk has been replaced, follow the instruction and "restore" the important parameters to the new SSD hard disk. When the main control board has been replaced, follow the instruction and "backup" the data to the new main control board.

NOTE 

Always perform the shutdown procedure before replacing the SSD hard disk or main control board, so the data will be automatically backed up by the software.

4-1

Software System

4.2 Calibration 4.2.1 Manual Calibration Users logged in with a service level account can enter the manual calibration screen to modify WBC/RBC/HGB/MCV/PLT/RBC-O/PLT-O factory calibration factors, Micro-WB transfer factor, PD transfer factor, and WBC-D transfer factor. Out-of-factory calibration factors should only be modified when it is absolutely necessary; and after modification, you must run samples and make sure the tests results are correct.

Figure 4-1

4-2

Software System

Figure 4-2

4.2.2 Calibration with Calibrators

Figure 4-3 Calibrator Interface at Service Access Level When performing calibration with calibrator at service access level, the analyzer calculates all 4-3

Software System

factory calibration factors automatically. The AL-WB calibration is used first. When there are 6 or more calibrations, you will be prompted to run the PD transfer factor calibration; when 6 calibrations are counted, a dialog box will be displayed prompting you to run the MicroWB calibration; when 6 calibrations have been done, you will be prompted to save the new calibration factors when exiting the screen. Before calibration, make sure to set up the lot numbers, expiration dates, analysis modes and the target values for the calibrators.

Parameters

Range

9

WBC

Factor

CV

≥ 4×10 /L

WB ≤ 2.5%

≥0.75

≤2%

Not Need

PD

and

＞2%，≤6%

Recommended

≤1.25

＞6%

Not Recommended

≤

4.0%

HGB

(110 ～ 180)

WB ≤ 1.0%

g/L*

PD ≤ 2.0%

12

RBC

≥3.5×10 /L

MCV

(80～100) fL*

9

PLT

≥ 100×10 /L

12

RBC-O

≥3.5×10 /L

9

PLT-O

≥ 100×10 /L

WBC-D

Same as WBC

WB ≤ 1.5% PD ≤ 2.0%

WB ≤ 1.0% PD ≤ 3.0% WB ≤ 4.0% PD ≤ 8.0%

WB ≤ 1.5% PD ≤ 2.0%

WB ≤ 4.0% PD ≤ 8.0% Same

≥0.75 and ≤1.25 ≥0.75 and ≤1.25

≤1.5% ＞ 1.5% ， ≤4.5% ＞4.5% ≤1.5% ＞ 1.5% ， ≤4.5% ＞4.5%

Not Need Recommended Not Recommended Not Need Recommended Not Recommended

≥0.75

≤1%

Not Need

and

＞1%，≤3%

Recommended

≤1.25

＞3%

Not Recommended

≥0.75

≤4%

Not Need

and

＞4%，≤10%

Recommended

≤1.25

＞10%

Not Recommended

≥0.75 and ≤1.25

≤1.5% ＞ 1.5% ， ≤4.5% ＞4.5%

Not Need Recommended Not Recommended

≥0.5

≤4%

Not Need

and

＞4%，≤10%

Recommended

≤1.5

＞10%

Not Recommended

as

WBC

CAUTION 

Software prompts

range

Never use expired calibrators.

4-4

Software System

NOTE 

If the calibrated factors or CVs are out of allowable range, they will be displayed in red, and the values cannot be saved.



Running calibration at service access level will reset the user-defined calibration factor to 100%.

4-5

Software System

4.3 Optical Gain Calibration Menu - Calibration - Optical Gain Calibration 1

Select the Calibrator mode.

2

Enter the gain targets.

3

Place a tube at the first tube position in a tube rack.

4

Start autoloading test.

5

When autoloading is completed, place the tube rack back to the loading area and run it again.

6

When valid gains are calculated, click “Save” and exit the current screen.

Figure 4-4 Note that the optical gain calibration factors will affect the test results. Always confirm run tests after optical gain calibration, and make sure the tests results are correct.

4-6

Software System

4.4 Review 4.4.1 Export Table Review-Export

Figure 4-5 Follow the software instruction to select the content to be exported. When there are many sample records, keep in mind that it will take you a relatively long time to export a large volume of data if you select to export all records, with the inf. files and graphs.

4-7

Software System

4.4.2 Special information

Figure 4-6 Meanings of special information HGB background voltage

The voltage when diluent is added to the HGB reaction bath

HGB measurement voltage

The voltage when blood sample and lyses are added to the HGB reaction bath

DIFF channel particle number

Total particle count at the DIFF channel

WNB channel particle number

Total particle count measured at the WNB channel

RET channel particle number

Total particle count at the RET channel

RBC particle number

Total RBC particle count at the impedance channel

PLT particle number

Total PLT particle count measured at the impedance channel

4-8

Software System

4.5 Setup screen 4.5.1 Maintenance Menu Setup-Maintenance 

Set the wait time before the analyzer entering standby.



Set up the auto probe cleanser maintenance time



Set up other conditions to trigger Probe Cleanser maintenance, including intervals (after setting the interval, a more complicated Probe Cleanser maintenance time sequence will be called. For example, the setting in below graph requires for every 7 days, the more complicated Probe Cleanser procedure will be performed during analyzer shutdown or during auto maintenance), and the total test thresholds for different channels.

Figure 4-7

4.5.2 Reagent Setup When there is no reagent-related error warnings 1

Select the reagents that need to be set (multiple options allowed). And tap “Setup”.

4-9

Software System

2

Scan or manually enter the barcode.

3

After setting up all the reagents, you can tap the Replace button.

Figure 4-8 When there are reagent-related warnings (reagent expired, low volume, etc.) 1.

Tap “Setup” on the “Reagent Setup” screen.

4-10

Software System

2

Scan or manually enter the barcode, and tap “Replace” to replace the reagents.

When the warnings occur during the auto-loading analysis process, a “reagent setup” dialog box automatically displays.

4-11

Software System

4.5.3 Communication

Figure 4-9 Communication setup

Data Communication Channel 

Choose LIS or labXpert



Note that if labXpert is selected here, when there are QC settings on the main unit software and the labXpert, the labXpert QC setting will prevail. LIS

When LIS is used, set the analyzer as the server, and the LIS serves as the client. The port is 5100. When LIS is selected, configure ACK synchronization overtime, auto retransmit,

auto

communication,

print

bitmap

transmission,

scattergram or histogram transmit methods etc. as necessary. labXpert

When “labXpert” is selected, “Reexam communication timeout” is set. The default value is 5 seconds.

Protocol setup 

IP Address: Set the IP for the analyzer; 10.0.0.12 by default Subnet mask: Subnet mask for the analyzer network; use 255.255.255.0 for most cases 4-12

Software System



Default gateway: Gateway IP



Mac address: The Mac address of the analyzer is fixed by manufacturer and cannot be changed.

4.5.4 Gain Setup Setup - Gains Setup

Figure 4-10 Gain setup Tap the WB, PD, and BF mode tabs, and set FS, SS, FL and PMT gains for the DIFF, WNB and RET channels. The MCV_G and HGB gains set on the WB mode are shared by all modes.

NOTE 

As the gain settings will affect the test results, be careful when you adjust them.

4.5.5 Auxiliary Setup Setup - Auxiliary Setup: to set sample ID entry method: Auto Increase or Manual Entry. Set up for the “First sample after startup”. Set whether to use Auto-Scan rack No.

4-13

Software System

4-14

Software System

4.6 Debug & Self-Test 4.6.1 Adjust. Sample Probe Positions Menu - Service - Debug & Self-Test - Adj. Sample Probe Pos.

Figure 4-11 For information about how to adjust sample probe positions, refer to 5.2.5 Sampling assembly. 1

Select the position to be adjusted.

2

Tap "Start".

3

Select "Fine Adjustment" or "Coarse Adjustment”.

4

After completing the adjustment, tap "Save Steps" to exit the screen.

5

The buttons in the “Position Observe” area are used to observe the positions after adjustment. Tap “Horizontal Pos.”, the sample probe moves horizontally and stays at a position above the target position (around the centre of its working position in the Y direction). Tap “Vertical Pos.” the sample probe lowers down to the target position. You can check whether the adjustment gives satisfactory results by observing the sample probe position against the fixture.

6

After the adjustment, tap the “Verfity” button to verify the positions other than the Vertical Direction Home Pos.. The sample probe moves to its final working position.Before position verification, take away the fixtures.

4-15

Software System

Figure 4-12 Note: pressing “All to Factory Settings” will restore all position adjustment values to the factory configuration.

4.6.2 Adjust Autoloader Position Menu - Service - Debug & Self-Test - Adjust Autoload Pos. 1

Select the position to be adjusted.

2

Tap "Start".

3

Select "Fine Adjustment" or "Coarse Adjustment”

4

After completing the adjustment, tap "Save Steps" to exit the screen.

5

Calibrate the position.

4-16

Software System

Figure 4-13 Note: pressing “All to Factory Settings” will restore all position adjustment values to the factory configuration.

4.6.3 Auto-loading Debug Menu - Service - Debug & Self-Test - Adjust Autoload Pos. includes: Mix Mechanism, Feed end pos., etc.

4-17

Software System

Figure 4-14

4.6.4 Sensor Debug Menu - Service - Debug&Self-Test - Sensor Debug includes: Dye Sensors. Recalibrate the sensor after replacing the sensor or DYE connection tubing. Calibration method: After taping Calibrate, check whether the analysis voltage is within the reference range, and then tap Save.

Figure 4-15

4-18

Software System

4.6.5 Optical Debug Menu - Service - Debug&Self-Test - Optical Debug To confirm optical system debug. For debug details, see 9.40 Optical System.

Figure 4-16

4-19

Software System

4.7 Status The “Status” menu displays the analyzer’s temperature, pressures, voltages, current, floater status and sensor status. You can also find the software version information under the menu.

Figure 4-17 Status-Sensor Status When you tap Menu-“Status”-“Sensor”-“Drive Board” and enter the sensor status screen, all the motors displayed on the screen (except for that of the DIL (10mL) syringe, the ASP (100uL) syringe and SP (250uL) syringe) are relased of the moment placed on them. You will see the tube gripper lowers down, and you can now move the aspiration assembly in the horizontal direction. When you exit the screen, the analyzer initializes all these motors to their original status by placing moment on them again

4.8 Indicators The indicator on the front cover of the analyzer may light in 3 colors. When it flickers, it flickers every 2 seconds. The indicator changes according to the instrument status, the table below describes the corresponding meanings: Table 4-1 Main unit status indicator Analyzer status

Indicators

Notes

Ready

Stay in green

Waiting for actions

Running

Flicker in green

Performing actions

Running with error

Flicker in red

Running with error

Error and not running

Stay in red

There is/are error(s), and the analyzer is not running

No error, but fluidic actions are not

Stay in yellow

allowed

Startup initialization or standby, not involving fluidic actions

4-20

Software System

Enter/exit standby

Flicker in yellow

Enter/exit standby

Sample Probe is lowering down (for

Quickly flicker in

/

open-sampling type analyzers

yellow

4-21

Software System

4.9 Advanced Toolbox The "Advanced Toolbox" provides two functions: language switch and data export The screen is shown below.

Figure 4-18 Advanced toolbox

4.9.1 Language Setup The analyzer supports the Chinese and English languages.

NOTE 

New language setting will become effective after analyzer re-start.

4.9.2 Debug Data Export You can use this function to export instrument information, software debug information, reproducibility test results, accuracy test results, factory calibration results, background test results, carryover results, aging data, as well as gain calibration results, system self-test results, version information, configuration information, inf. files, user operation logs and LIS communication logs.

4-22

Software System

Figure 4-19 Debug Data Export

NOTE 

The USB should have been formatted to FAT32 before you copy and paste the "update" directory to it.



Recommended USB models: Kingston 8/16G, SanDisk 8/16G, Maxell 4/8G.



Make sure there is enough free space (at least 4G) on the USB.

See the table below for the specific exported data type when you select each software option. Table 4-2 Exported data by options Software option

Exported data

Instrument information

Software

Notes version,

The following items are all saved in

temperature and pressure,

a single csv file:

sensor status, floater status,

Software version, temperature and

voltage¤t,

gains,

pressure, sensor status, floater

calibration factors,

aging

status,

performance

data,

blank

calibration factors, heating debug

performance

data,

data (table), laser diode debug

count

4-23

voltage¤t,

gains,

Software System

Software option

Exported data

Notes

carryover

performance

data,

repeatability

performance

data,

logs,

calibration logs, L-J QC data,

X-B

accuracy

QC

data,

data, heating

debug data (table), pressure debug data (table), laser diode debug data, baseline debug data

data, baseline debug data

The following information are saved respectively, in different csv. Files: aging performance data,

blank

count performance data, carryover performance

data,

repeatability

performance data, logs, calibration logs, L-J QC data, X-B QC data, accuracy data, pressure debug data (table)

SW debug data

Information of Table Review

/

screen Inf file

Inf file, curve file

/

Sample data

Trace logs, update logs,

/

labXpert

communication

logs, pressure debug data, pressure

debug

data,

database file (6000.db), etc file folder, config file folder, optical debug data

4.9.3 Enable “Low Speed Scan” for Low Quality Sample Barcode This function is only available on analyzers configured with a built-in barcode scanner. When the barcode labels used at customer’s site are not of good quality, for example, not clear, or are contaminated, or get worn out, enable “Low speed scan”.

NOTE 

When “Low speed scan” is enabled, inform the user that the analyzer throughput will lower down a little.

1

Tap "Menu" > "Service" > "Advanced Toolbox" to enter the “Advanced Toolbox” screen.

4-24

Software System

2

Check “With internal barcode scanner” and “Low speed scan”.

4-25

Software System

4.10 Software Update 4.10.1 Prepare the USB for update Copy the update.tar.gz file to the root directory of the formatted USB.

NOTE 

The USB should have been formatted to FAT32 before you copy and paste the "update" directory to it.



Only the update.tar.gz file is in the root directory of the USB. You must not modify the file name. You must not unzip the file.

4.10.2 Update 1

Insert the USB to one of the USB ports on the analyzer, and perform update following either of the below methods:

2

Version Info. - Details - Update;

Figure 4-20 Version Info. The "Update" process includes two steps: Step 1: update the guide and operation system; 4-26

Software System

Step 2: update the software module. If the update guide and the operation system are also needed to be updated, the system will prompt you to restart the analyzer between step 1 and step 2; if only the software module need to be updated, the update will start from step 2 directly.

CAUTION 

Do not pull the USB or disconnect power during the update; otherwise the analyzer may not start.

NOTE 

The update usually takes about 10 minutes but depends on the number of modules to be updated. Do not leave the analyzer as the process requires user operation.

4.10.3 When Update Fails If the update fails, try again.

4-27

Software System

4.11 Communication Troubleshooting 

Physical connection

Check whether the network cable is properly connected; and whether the network physical connection is correct. 

Communication

Check whether the network settings (including the communication setup for both analyzer and LIS) are correct. 

Network firewall

4-28

Chapter 5 Mechanical System 5.1 Introduction to Mechanical Structure The analyzer is mainly composed of the following components: cover, rack, autoloader, optical assembly, sampling assembly, rotary scanning assembly, stabilizing assembly, power supply, hardware board, syringe, dosing pump, bath, valve assembly, wires, pipes, etc. And their specific positions are introduced in the following figure.

Figure 5-1 Main unit structure 1

Figure 5-2 Main unit structure 2

5-1

Mechanical System

Figure 5-3 Main unit structure 3 1

Autoloader

2

Pinch valve assembly

3

Power supply

4

Bürkert valve

5

Bath assembly

6

Optical assembly

7

Gas tank

8

Valve Drive Board

9

Heating control board

10

Valve Drive Board

11

Hard disk

12

Main Control Board

13

Preheating

14

Display

15

DYE detection sensor

18

Waste

bath

assembly 16

screen

and

cover

DYE bag

17

Sampling assembly

and

reagent

connector 19

Reagent

detection

20

Valve assembly

21

Dosing pump assembly

assembly 22

Valve assembly

23

Bath assembly

24

Gas Valve assembly

25

Syringe

26

Rotary

27

Scanner

30

RET

scanning

assembly 28

HGB

test

bath

29

assembly 31

RBC test assembly

DIFF

reaction

bath

assembly 32

Right

reaction

bath

assembly

side

valve

33

Network Interface

assembly 34

USB ports

5.1.1 Front Side of the Analyzer The front side of the analyzer mainly includes the touch screen and buttons, as well as the autoloader door (closed-sampling model). Their positions are as follows.

5-2

Mechanical System

Figure 5-4 Front side of the Analyzer 1 --- Touch screen

2 --- Count/Mode switch key

3 --- Indicator

4 --- Autoloader door (closed-sampling model)

5.1.2 Rear Side of the Analyzer The rear side of the analyzer mainly includes the network port, power socket, reagent inlets and exhaust fan. Their positions are as follows.

Figure 5-5 Rear side of the Analyzer

5-3

Mechanical System

1 --- Network port

2 --- AC input

3---- M-6LH Lyse inlet

4---- M-6LN Lyse inlet

5---- M-6LD Lyse inlet

6---- M-6DR Diluent inlet

7---- DS Diluent inlet

8---- Waste outlet

5.1.3 Left Side of the Analyzer On the left side of the analyzer, the reagent inlets and reagent detection are at the lower left side; the valves controlling various tubes, dosing pump assembly, and dosing pump are located in the middle part; the syringes are distributed at the lower right side to provide power for the accurate aspiration. See the following figure.

Figure 5-6 Left Side of the Analyzer 18

Fluid

and

reagent

19

connector 21

Dosing

Reagent

detection

20

Valve assembly

23

Bath assembly

assembly pump

22

Valve assembly

25

Syringe

assembly 24

Gas Valve assembly

5.1.4 Right Side of the Analyzer The right side of the analyzer mainly includes HGB bath, DIFF reaction bath, RET reaction bath (only for high-configuration models), RBC bath, and four USB ports. Refer to the following figure for their specific positions.

5-4

Mechanical System

Figure 5-7 Right Side of the Analyzer 28

HGB test bath assembly

29

DIFF

reaction

bath

30

assembly 31

RBC test assembly

32

Right

34

USB ports

5-5

reaction

bath

assembly side

assembly

RET

valve

33

Network Interface

Mechanical System

5.2 Mechanics Subsystem Introduction 5.2.1 Autoloader The autoloader is used for storing and transporting the tube rack. There are two types of autoloaders, the OV type autoloader which is used with the opensampling type analyzers, and the CT type autoloader, which is used with the closed-sampling type analyzers. The only differences between the two autoloaders is that the OV type autolader has an open loading space and an [Aspirate] key, and the latter has a closed sample compartment. However, the auto loading structure and functions of the two autoloaders are exactly the same. Front housing locking screw

OV aspirate key

Figure 5-8 Autoloader for open-sampling type analyzers Front housing locking screw

Closed sample compartment

Figure 5-9 Autoloader for closed-sampling type analyzers

The two types of autoloaders can either be used with the tube rotatory scanning mechanism (with the built-in barcode scanner) and the tube detection assembly. Therefore there are in total 5-6

Mechanical System

4 configurations:

For open-vial sampling type analyzer

It not only detects the presence of test tubes, but also scans tube and tube barcodes

The sample number can be either a barcode number or an auto-increment number

With tube detection assembly

Only detect the presence of test tubes

The sample number can be automatically increased

With rotary scan mechanism (including internal barcode scanner)

It not only detects the presence of test tubes, but also scans tube and tube barcodes

The sample number can be either a barcode number or an auto-increment number

Only detect the presence of test tubes

The sample number can be automatically increased

With rotary scan mechanism (including internal barcode scanner) Mutually exclusive, only one can be selected

OV autoloader

Autoloader

Mutually exclusive, only one can be selected

CT autoloader

With tube detection assembly For closed-tube sampling type analyzer

Figure 5-10 Different configurations for autoloaders In order to simplify the description, if there is a need for the explanation in later sections, only pictures of two configurations will be shown: a CT autoloader with a rotary scanning mechanism and an OV autoloader with a tube detection assembly. Test tube rotary scanning assembly

Loading in-position detection switch

Back supporting board assembly Loading tray face plate

Front supporting board assembly

Unloadin g tray face plate

Tray full detection sensor

Loading mechanism

Unloading mechanism

Feeding mechanism

Closed sample compartment assembly

Figure 5-11 Closed-sampling type autoloader + Rotary scanning mechanism

5-7

Mechanical System Tube Rack Loading InPosition Detection Switch

Tube detection assembly

Back supporting board assembly

Loading tray face plate

Front supporting board assembly

Loading mechanism

Unloading tray face plate OV tube Aspirate key stopper detection switch

Tray full detection sensor

Unloading mechanism

Feeding mechanism

Figure 5-12 Open -sampling type autoloader + Tube detection assembly Facing to the autoloader, the function positions in the autoloader analysis area are arranged as follows, where the tube detection position and the barcode scan position overlap. However, only the autoloader with a rotary scanning mechanism has the tube barcode rotary scanning function.

Empty Empty

Empty

Empty

Empty

Piercing

Mix

Empty

Tube detection Barcode scanning

Figure 5-13 Layout of positions in the autoloader analysis area

5-8

Empty

Mechanical System

Figure 5-14 Installation method of autoloader and main unit The main unit supports the autoloader with two crossbeams. When the autoloader is installed on the analyzer, make sure that the positioning pin of the autoloader is inserted into the corresponding pin hole of the main unit, and that the left and right sides of the autoloader back metal contact the baseplate of the main unit (refer to Figure 5-14 and Figure 5-15 . If they do not contact the main unit baseplate, which means that the wire is inserted or the autoloader is not pushed into the correct position). Then pre-tighten the connecting screws at the bottom of the autoloader to the crossbeam.

Figure 5-15 Autoloader needs to contact with the main unit (right side)

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Mechanical System

Figure 5-16 Autoloader needs to contact with main unit (left side) Before powering on the main unit, first confirm the relative position of the main unit to the autoloader. The procedure is as follows: pull the sampling assembly to the position in the upper front of the floating blood barrier, and visually inspect whether the center of the probe wipe groove is aligned with the center of the floating blood barrier limit slice (distance ≤± 0.5 mm). If it is not convenient to observe, you can press the sample probe downwards a little by hand to observe the alignment of the probe tip and the center of the blood barrier limit slice, but do not let the sample probe get into contact with any hard object. After confirming the alignment, lift the sample probe to avoid bending the sample probe when horizontally dragging the sampling assembly. If the center of the sampling assembly probe wipe groove is not aligned with the center of the floating blood barrier limit slice, or the tip of the sample probe is not aligned with the center of the blood barrier limit slice, you need to remove the right cover of the main unit, loosen the positioning pins on the main unit (refer to Figure 5-17). Then move the autoloader left or right to align the positions of the main unit and the autoloader. Make sure that there is no gap between the back of the autoloader and the main unit when moving the autoloader. After the alignment, tighten the positioning pin screw of the main unit and the connection screw between the bottom of the autoloader and the crossbeam.

5-10

Mechanical System

Probe wipe

Blood barrier limit slice

Figure 5-17 Main unit and autoloader position confirmation

Figure 5-18 Main unit and autoloader position confirmation

5-11

Mechanical System

Figure 5-19 Main unit positioning pin hole The autoloader's auto-loading mechanism includes a loading mechanism, a feeding mechanism, an unloading mechanism, a back supporting board assembly, a front supporting board assembly, etc. The closed autoloader also includes a closed sample compartment. Loading Mechanism The function of the loading mechanism is to achieve longitudinal loading of the tube rack in preparation for feeding the tube rack into the analysis area. If there is a tube rack on the loading tray, the loading mechanism will trigger the micro-switch when pushing the tube rack (does not trigger the end position sensor). If there isn't a tube rack on the loading tray, the loading mechanism will trigger the end position sensor. Loading motor

Loading end position sensor

Right pincher height adjustment bracket Loading home position Left pincher height sensor adjustment bracket

Figure 5-20 Loading mechanism The role of the pincher height adjustment bracket is to adjust the height of the pincher relative to the loading tray, and to ensure that the top of the pincher does not exceed the Figure 5-22 upper limit, the bottom of the pincher does not exceed the lower limit. 5-12

Mechanical System

Right pincher

Left pincher

Figure 5-21 Note height requirements of the pincher

Upper limit Lower limit

Figure 5-22 Loading pincher height limit for pushing tube rack Feeding mechanism The feeding mechanism sends the tube rack to be tested into the analysis area. The feed mechanism of the instrument is used to feed or retract the tube rack. When feeding, the retracting pincher is under the face plate. When retracting, the feeding pincher is under the face plate.

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Mechanical System

Retracting pincher 2

Feeding pincher 1

Retracting pincher 1

Feeding pincher 2

Feeding home position sensor

Feeding motor

Figure 5-23 Feeding mechanism Unloading mechanism The function of the unloading mechanism is to push the tested tube rack into the unloading tray. There is a reflective sensor at the end of the unloading tray to detect whether the tube rack of the unloading tray is full. Unloading pushing plate

Unloading motor

Unloading home position sensor

Figure 5-24 Unloading mechanism Front supporting board assembly The front supporting board assembly and back supporting board assembly form the feeding channel for a tube rack together, which limits the front-back position of the tube rack in the analysis area. The front supporting board is equipped with a floating blood barrier, which is used to prevent the blood from splashing on the bottom of the sampling assembly probe wipe and form the blood slag when puncturing the tube (falling the blood slag into the reaction bath will change the measurement result). The left-right position, the front-back position of the front supporting board can be adjusted, and the height of the floating blood barrier bracket relative to the front supporting board can also be adjusted. Adjust the front-back position of the front supporting board in order to make the 5-14

Mechanical System

feeding channel width suitable for passing through the tube rack, the purpose of adjusting the left-right position is to align the theoretical center of the floating blood barrier with the theoretical center of the tube rack. Adjust the height of the floating blood barrier to allow the tube to pass safely. Floating blood barrier Blood barrier limit bracket

Floating blood barrier bracket

Test tube limit slice

Front supporting board

Figure 5-25 Front supporting board assembly If the front supporting board is disassembled while repairing the autoloader, you need to readjust the front-back position and the left-right position of the front supporting board with the fixture shown below. Floating blood barrier height adjustment positioning surface

Floating blood barrier left-right position adjustment positioning surface

Feeding channel width adjustment positioning surface

Tube detection assembly left-right position adjustment positioning surface Rotary scanning mechanism rotating wheel assembly leftright position adjustment positioning surface

Left counter pinch roller groove

Right counter pinch roller groove

Figure 5-26 Autoloader feeding channel adjustment fixture

5-15

Mechanical System

Push th e fixtu re to th e ri ght from on e side of the unlo ading tray into th e feeding chann el

The left and right cou nte r pinch rolle rs ar e p ressed at the lowest position of the fixtu re groove

The bottom su rfa ce of the floating blood bar rier bracket is close to the positioning surface o f th e fixture, lock the flo atin g bloo d b arrier rack screw ① and ②

Move the front suppo rtin g boa rd l eft or r ight to make the left sid e o f the floating bloo d b arrier rack closely contact with th e fixtu re positioning surface (but do not mo ve the fixtu re)

Push th e fron t su pporting boa rd to th e d irection of the back supp orti ng b oard to make the fron t supporting boa rd closely contact with the fixtu re

Lock the fr ont suppo rtin g boa rd l ocking scr ew ③ and ④

Confirm with the test tub e r ack. When drag the te st tube ra ck through the fe eding channe l, there should be no obvious friction. If obvious friction is detecte d, adju st a gain

End

Figure 5-27 Front supporting board assembly adjustment step and method with fixture Before starting the adjustment, make sure that the left and right counter pinch rollers are pressed on the bottom of the groove

Push the fix ture into the feed ing channel from left to right

Figure 5-28 Fixture placement requirements

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Mechanical System

The bottom surface of the floating blood barrier assembly is close to the positioning surface of the fixture, and then tighten the screw ① and ②

①

②

④ ③

The left side of the floating blood barrier assembly is close to the fixture positioning surface, and push the front supporting board in the direction of the red arrow to make it close to the fixture, then tighten the screw ③ and ④

Figure 5-29 Front -back, left-right position adjustment for front supporting board assembly You can take the tube rack as a temporary fixture and adjust the front supporting board assembly as follows if the adjustment fixture is not available: Draw a vertical line in the center of the U-shaped groove which is in the middle of the front supporting board

Draw a tick mark in the center of the tube position 6's top surface on the test tube rack

Push the test tube position 6 to the auto-sampling position

The left and right counter pinch rollers are pressed at the lowest position of the test tube rack groove

Move the front supporting board assembly left or right to align the vertical line drawn on the front supporting board with the scale drawn on the test tube rack

Ensure that the front and back supporting boards are roughly parallel and the spacing between them is slightly wider than the test tube rack

Lock the front supporting board locking screw ③ and ④

Confirm with the test tube rack. When drag the test tube rack through the feeding channel, there should be no obvious friction. If obvious friction is detected, adjust again

Adjust the floating blood barrier bracket height to make the blood barrier and the sample probe wipe be separated by 2 to 3 mm, and lock the floating blood barrier bracket screw ① and ②

Put a test tube (length ≤ 85 mm) on the test tube rack to make the bottom of the blood barrier 1 mm higher than the top surface of the test tube, otherwise readjust the blood barrier rack height

End

Figure 5-30 Front supporting board assembly adjustment steps and methods without fixtures

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Mechanical System

Figure 5-31 Left-right position adjustment method for front supporting board assembly

The distance between the front and back supporting boards is slightly wider than the width above the test tube rack, and there is no obvious friction when dragging the tube rack through the feeding channel.

20.4mm 20mm

Figure 5-32 Front-back position requirements for front supporting board assembly

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Mechanical System

D=2~3mm

The bottom of the blood barrier is higher than the test tube

Figure 5-33 Height requirements for floating blood barrier bracket

The front-back position of the limit slice can be adjusted to ensure that the front of the limit slice abuts against the test tube rack

Figure 5-34 Installation requirements for tube rack limit slice The front-back position of the tube rack limit slice is adjusted with a tube rack. Make sure the frontal side of the limit slice is locked against the tube rack. Back supporting board assembly The back supporting board assembly and front supporting board assembly together form the feeding channel for a tube rack, which limits the front-back position of the tube rack in the 5-19

Mechanical System

analysis area. The back supporting board assembly is equipped with left and right counter devices. The left and right counter devices can not only press the tube rack (to prevent the lateral movement of the tube rack while puncturing or mixing the tubes), but also detect whether the tube rack has moved when feeding or retracting the tube rack. Back supporting board

Left counter pinch roller Left counter rotation block

Right counter pinch roller Right counter rotation block

Left counter photocoupler Right counter photocoupler

Left counter photocoupler barrier

Right counter photocoupler barrier

Figure 5-35 Back supporting board assembly

Groove Step

Figure 5-36 Test tube rack There are 10 grooves in front of the tube rack (one groove for each tube position), and there are steps between the grooves. When the tube rack enters the analysis area, the left counter pinch roller or right counter pinch roller presses in the groove of the test tube rack. When the test tube rack moves laterally, the pinch roller will go through the groove step groove process. The counter sensor will produce a change in the state of blocked non-blocked blocked and the corresponding test tube rack moves one position. In order to generate the correct sensor signal, the sensor barrier is required to completely block the sensor when the pinch roller is in the groove, and the sensor barrier is completely out of the sensor when the pinch roller is on the step. The position of the counter sensor barrier relative to the sensor is adjustable left or right. Adjust it referring to the following steps:

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Mechanical System

The left and right cou nte r p inch rolle rs ar e p ressed at the lowest position of the te st tube rack gr oove

Push th e test tube position 5 to the autosampling position

Push th e test tube rack to the left to make the pinch rolle r stop on the steps

Adju st the left-righ t positi on of th e pho tocoup ler barrier to make the barr ier block the photocoupler and at least 1 mm pa ss the pho tocoup ler end face

Make sure the photocouple r ba rrier is completely ou t of the photocouple r an d the distance from the ph oto cou pler end face is abo ut 1 mm. Otherwise, repe at ste p 3 to read just th e b arrier position

End

Figure 5-37 Counter sensor barrier adjustment steps and methods

The pinch roller is pressed at the lowest position of the groove

d≥1mm

When the pinch roller stops at the lowest position of the groove, the photocoupler barrier completely blocks the photocoupler detection zone and passes at least 1 mm beyond the end face of the photocoupler detection zone.

Figure 5-38 Counter sensor barrier adjustment method

d≈1mm

The pinch roller is pressed on the step

When the pinch roller stops on the step, the photocoupler barrier completely disengages from the photocoupler detection zone and is approximately 1 mm from the end face of the photocoupler detection zone.

Figure 5-39 Counter sensor barrier position confirmation 5-21

Mechanical System

Tube detection assembly For the analyzer that is not equipped with a rotary scanning mechanism, a tube detection assembly is mounted on the autoloader back supporting board. The tube detection assembly is located at the tube detection position. The function of this assembly is to detect whether there is a tube on the tube rack passing through the tube detection position. The tube detection assembly on the back supporting board can be adjusted left or right. You can adjust the left-right position of the tube detection assembly by using the same fixture for adjusting the front supporting board assembly as shown in the figure below. Tube detection assembly is tightly pressed to this positioning surface and tightly locked The premise is that the left and right counter pinch rollers of the back supporting board assembly are pressed at the fixture groove

Figure 5-40 Adjustment method for tube detection assembly position (with fixture) If the fixture is not available, you can also use the tube rack to execute the adjustment as follows.

The premise is that the left and right counter pinch rollers of the back supporting board assembly are pressed at the lowest position of the test tube rack groove

Visual inspection: The center of the tube detection assembly and the center of the tube rack hole position are roughly coincident

Figure 5-41 Adjustment method for tube detection assembly position (without fixture)

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Mechanical System

Sample compartment assembly The sample compartment assembly is used for measuring the inserted STAT samples Whole blood position Tube stopper

Micro WB position Photocoupler barrier

Micro-switch

Compartment home position photocoupler

Limit panel

Sample compartment motor

Micro-switch cable binding panel

Compartment body assembly

Rail protector

Figure 5-42 Sample compartment assembly Adapter Clamping block Compression nut

Micro-switch

Compression spring

Adapter base Adapter spring Adapter nut

Figure 5-43 Compartment body assembly There are 2 sample positions in the compartment body assembly. The whole blood position is used to measure whole blood samples and body fluid samples. The Micro-WB position is used to measure Micro-WB samples and pre-diluted samples. The sample compartment assembly is mounted on the bottom of the closed autoloader and the left-right position is adjustable relative to the bottom panel.

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Mechanical System

Sample compartment assembly locking screws, when loosening the screws, sample compartment assembly can be adjusted left or right

Figure 5-44 Sample compartment assembly fixing method on the bottom panel of the closed autoloader The left-right position of the sample compartment should be adjusted with reference to the sample probe. When using the probe in the whole blood position, make sure the probe can be roughly aligned with the center of the fixing hole. The sample probe is centered around the whole blood position of the sample compartment assembly

Figure 5-45 Left-right position adjustment method for sample compartment assembly In addition, the micro-switch connection wire of the sample compartment will move when opening or closing the sample compartment. In order to prevent the wires from being worn out due to wear, the wires should be avoided touching the face plate hem during the movement.

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Mechanical System The cable does not touch the panel during the movement

Figure 5-46 Wiring considerations for sample compartment micro-switch connection

5.2.2 Rotary Scanning Assembly (With Built-in Scanner) The rotatory scanning assembly supports sample barcode scanning and tube rack barcode scanning; besides, it has the tube detection function. The rotary scanning assembly includes a tube fixing mechanism, a tube rotary mechanism, and a scanner. The tube fixing mechanism and the scanner are fixed in front of the front panel of the main unit, and the tube rotary mechanism is fixed on the autoloader. Tube rotary motor

Coupling

Rotating wheel front-back adjustment panel

Rotating wheel Rubber wheel

Bracket

Figure 5-47 Test tube rotary mechanism The support rack is fixed with the autoloader and its left-right position is adjustable relative to the autoloader, while the front-back position of the rotating wheel front-back adjusting plate is adjustable relative to the support rack.

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Mechanical System

Rotating wheel frontback adjustment panel locking screws, when loosening the screws, the rotating wheel can be adjusted forward and backward

Figure 5-48 Fixing method for rotating wheel front and rear adjustment panels

Remove the rubber wheel to make the frontback, left-right directions of the rotating wheel be tangent to the curved surface set by the fixture The premise is that the left and right counter pinch rollers of the back supporting board assembly are pressed at the lowest position of the fixture groove

Figure 5-49 Front-back, left-right position adjustment method for tube rotary mechanism (with fixture) When the fixture is available, the left-right, and front-back positions of the tube fixing mechanism can be adjusted directly in accordance with the above figure. If there is no fixture, use the tube rack to visually inspect and adjust the left-right position first to make the rotating wheel roughly align with the tube rack tube position. Then adjust the front-back position: make the rotating wheel slightly protrude toward the tube rack tube position, to make the tube not only pass through normally but also contact with the rotating wheel. After the adjustment, push the tube gently in the direction of the rotating wheel, and try to rotate the rotating wheel to see if it can rotate normally. If the tube is stuck or does not move, you need to readjust the position.

5-26

Mechanical System The left and right sides of the rotating wheel are roughly aligned with the test tube rack hole

The premise is that the left and right counter pinch rollers of the back supporting board assembly are pressed at the lowest position of the test tube rack groove

Figure 5-50 Front-back, left-right position adjustment method for tube rotary mechanism (without fixture) Photocoupler lead binding hole

Test tube compression motor

Photocoupler lead fixing panel

Back photocoupler barrier Compression mechanism photocoupler

Sliding support Spring Front photocoupler barrier

Guide rod

Pinch roller fixed support Pinch roller

Figure 5-51 Tube fixing mechanism The fixing mechanism sensor is fixed on the sliding support and can be moved forward or backward following the sliding support; the front sensor barrier is fixed on the pinch roller fixing support, and can be moved forward or backward following the pinch roller fixing support. The principle of the tube fixing mechanism for detecting the presence or absence of a tube is: The stepping motor drives the sliding support forward through the synchronous belt, and the sliding support pushes the pinch roller fixing support moving forward together through a spring. 

If there is a tube at the tube detection position, when the pinch roller comes into contact with the tube, the forward movement of the pinch roller fixing support will be stopped. However, the sliding support keeps moving forward with the compression mechanism sensor. There will be a relative motion between the sensor and the front sensor barrier, 5-27

Mechanical System

and finally the compression mechanism sensor will be blocked by the front sensor barrier; 

When there is no tube at the tube detection position, there is no obstacles restricting the pinch roller movement, the compression mechanism sensor and front sensor barrier will move forward together, so the sensor will not be blocked by the front sensor barrier.

Therefore the sensor signal blocked/unblocked status indicate whether there is a tube at the tube detection position. The front-back position of the front sensor barrier located on the pinch roller fixing support is adjustable. In order not to miss or mistakenly detect tubes, adjust the front sensor barrier position referring to the following figure.

When the spring is not compressed, the end position photocoupler barrier is flush with the frontal side of the photocoupler

Figure 5-52 Front-back position adjustment requirements for front sensor barrier The compression mechanism sensor moves with the sliding support. In order to prevent the sensor cable from being worn out, the sensor cable must be bundled on the sensor lead fixing panel and fixed under the sensor lead binding hole as shown below:

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Mechanical System

Figure 5-53 Bundling requirements for compression mechanism sensor lead The tube fixing mechanism locking screws, when loosening the screws, the fixing mechanism can be adjusted left or right

Figure 5-54 Fixing method for compression mechanism on the front panel The compression mechanism can be adjusted left or right on the front panel. Insert a tube rack in the feeding area, making sure that the counter pinch roller is at the lowest position of the tube rack groove, and adjust the pinch roller of the tube fixing mechanism to be roughly centered with the tube rack hole position (use the left and right sides of this tube rack hole position for reference, deviation ≤ ± 0.5mm).

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Mechanical System

Figure 5-55 Left-right position adjustment method for compression mechanism After adjusting the tube fixing mechanism and tube rotary mechanism, the adjustment effect can be confirmed on the autoloader self-test screen. Select MenuServiceDebug&Self-TestSelf-Test, select the Autoloading Assembly to enter the autoloader self-test screen.

Figure 5-56 Path for entering self-test screen Tap the button first, and then put an empty tube rack on the first row of the loading tray. Put an empty tube into the first tube position of the tube rack, and tap the button twice to send the empty tube to the scanning position. Then tap to see if the tube can rotate. 5-30

Mechanical System

Figure 5-57 Autoloader assembly self-test screen

5.2.3 Test Tube Stabilizing Mechanism The stabilizing mechanism is used to eliminate the random oscillation of the tube in the tube rack during pinching and make the tube oscillate in a fixed direction, which can prevent the sample probe from sticking on the tube cap, then the probability of bending the probe can be reduced. Wheel

Front-back adjustment bracket

Stabilizing mechanism bracket

Clamping block

Rotating bracket Spring piece

Figure 5-58 Stabilizing mechanism The stabilizing mechanism is fixed below the sampling assembly of the main unit front panel. 5-31

Mechanical System

And the stabilizing mechanism can be adjusted in right-left direction relative to the main unit front panel.

Stabilizing mechanism locking screws, when loosening the screws, the stabilizing mechanism can be adjusted left or right

Figure 5-59 Fixing the stabilizing mechanism on the front panel Select MenuServiceDebug&Self-TestSelf-Test, select the Autoloading Assembly to enter the autoloader self-test screen.

Figure 5-60 Path for entering self-test screen

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Mechanical System

Figure 5-61 Autoloader assembly self-test screen Tap the button first, and then put an empty tube rack on the first row of the loading tray. Tap the button five times to send the first position of the tube rack to the piercing position. Use your hand to press the wheel of the stabilizing mechanism and observe whether the stabilizing mechanism clamping block is exactly centered with the front opening of the tube rack. If the right and left sides of the clamping block are close to the tube rack, you need to adjust the left-right position of the stabilizing mechanism.

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Mechanical System

Figure 5-62 Ideal position of the stabilizing mechanism clamping block relative to the tube rack

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Mechanical System

Front-back adjustment bracket locking screws, when loosening the screws, the clamping block can be adjusted forward or backward

Figure 5-63 Front and rear adjustment structure for stabilizing mechanism clamping block The front-back position adjustment requirements of the stabilizing mechanism are as follows: When the wheel is not pressed, the clamping block should be adjusted to a position about 1 mm behind the autoloader back supporting board (in order not to interfere with the tube rack feeding).

d≈1mm

Figure 5-64 Front and rear adjustment visual inspection method for stabilizing mechanism clamping block (top view)

5.2.4 Mixing Assembly The mixing assembly is used to reverse and mix samples during the auto-sampling measurement. The mixing assembly is fixed to the rear of the main unit front panel. 5-35

Mechanical System

Lift motor (Z direction motor)

Z direction end position photocoupler R direction photocoupler barrier

R direction home position photocoupler Z direction home position photocoupler

Mix motor (R direction motor)

Y direction end position photocoupler Y direction home position photocoupler

Shift motor (Y direction motor)

Y direction photocoupler barrier

Figure 5-65 Mixing assembly (rear view)

Z direction home position photocoupler

Tube gripper Gripper pressing panel

Figure 5-66 Mixing assembly (front view)

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Mechanical System

Mix assembly locking screws, when loosening the screws, mix assembly can be adjusted left or right

Figure 5-67 Fixing mixing assembly to the front panel of the main unit After disassembling the mixing mechanism, it is necessary to re-adjust the front-back position, left-right position, and height of the tube gripper relative to the tube rack so as to ensure the reliability of the gripper for removing the tube. In order to prevent interference during the adjustment process, it is necessary to loosen the screws on the power-off protection board of the mixing assembly first, then push the protection board to the right, and lock one screw (to prevent the protection board from moving). Mix assembly power-off protection board, loosen the 3 screws of the poweroff protection board before adjusting the mix assembly. Push the power-off protection board to the right and tighten 1 screw.

Figure 5-68 Mixing assembly power-off protection board

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Mechanical System

Enter the autoloader self-test screen (refer to Figure 5-69 and Figure 5-70), tap the button, and then put an empty tube rack on the first row of the loading tray. Tap the button five times to send the first position of the tube rack to the piercing position. Select Menu  Service  Debug & Self-Test  Adjust Autoload Pos., then select Mix mechanism, tap , and then tap .

Figure 5-69 Path for entering Adjust Autoload Pos. Adjust the left-right position of the mixing assembly on the front panel of the main unit, and tap the , , , and buttons on the Figure 5-70 screen to move the gripper until it is roughly aligned with the tube in front-back and left-right directions. After the adjustment, tighten the four locking screws of the mixing assembly (the gripper position may shift in the process of tightening the screws, which may require multiple adjustments), tap , and then tap . Place a tube into the mix position, and tap the button. When the tube is placed back into the tube rack, observe if the tube obviously interferes with the tube rack. If yes, you need to readjust the mixing assembly.

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Mechanical System

④

⑤

⑥

Figure 5-70 Mixing mechanism adjustment screen

Figure 5-71 Left-right, front-back position confirmation for mixing mechanism If you have exceeded the adjustment range when tapping the , , , and button but still failed to adjust the mixing mechanism to a proper position, loosen the 2 inner hexagon locking screws of the tube gripper (as shown in the following figure), and adjust the front-back position and angle of the gripper on the shaft. If it is hard to manage these 2 screws, you can tap  to raise the gripper and operate. After adjusting the front-back position and angles of the gripper relative to the shaft, 5-39

Mechanical System

tighten the screws (be sure to lock them tightly), tap to return the gripper back to the original position, and then readjust the left-right, front-back positions of the mixing gripper.

Tube gripper locking screw

Figure 5-72 Tube gripper locking screws After adjusting the front-back, left-right positions of the tube gripper, adjust the height of the tube gripper. The distance between the gripper bottom surface and the tube rack top surface needs to be controlled within (1.5-2.5) mm, and the bottom surface of the gripper pressing panel is slightly lower than the bottom surface of the blood barrier.

The bottom of the gripper pressing panel is slightly lower than the bottom surface of the blood barrier d=(1.5~2.5)mm

Figure 5-73 Tube gripper height adjustment method After adjusting the tube gripper height relative to the tube rack, adjust the distance between the power-off protection board and gripper. Tap   in Figure 5-70, adjust the distance between the power-off protection board and gripper to the range of (1.5 to 2.5) mm. After the adjustment, tap to restore the gripper position.

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Mechanical System

(1.5~2.5)mm

Figure 5-74 Distance requirements between tube gripper and power-off protection board After adjusting the above positions, put a tube into the mix position, and tap the button to confirm the adjustment effect.

5.2.5 Sampling assembly The sampling assembly is used to aspirate and dispense the sample. Hose fixing bracket

Vertical (Z direction) motor

Horizontal confirm position photocoupler Vertical home position photocoupler Horizontal (Y direction) motor

Probe wipe

Sample probe

Shielding cover

Horizontal home position photocoupler barrier Horizontal home position photocoupler

Figure 5-75 Sampling assembly

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Mechanical System

Piercing slide

When replacing the sample probe, pay attention to the mounting direction of the sample probe

Nut

Lead screw

Figure 5-76 Sampling assembly Table 5-1 Sample probe aspirating and dispensing positions Open-sampling type

Closed-sampling type

Aspiration

Auto-sampling position, open-

Auto-sampling position, CT-WB sampling

positions

vial sampling position

position, CT-micro-WB sampling position

Dispensing positions

HGB bath, WNB bath, DIFF bath, RET bath (high configuration type), RBC bath

Table 5-2 Situations that need to re-confirm or re-adjust sample probe position Situations for reconfirming or

Position

readjusting sample probe position (1) When having reassembled or replaced

Vertical direction home pos.

the vertical home position sensor

Vertical

(2) When having replaced the sampling assembly

Open-vial sampling position

/

Not required Only for closed-sampling type: (1) When having reassembled or replaced

CT sampling position

Front-back, left-

the sampling assembly

(common tube)

right, vertical

(2) When having replaced the autoloader (3) When having reassembled or replaced the sample compartment assembly Only for closed-sampling type:

CT sampling position

Front-back, left-

(1) When having reassembled or replaced

(micro tube)

right, vertical

the sampling assembly (2) When having replaced the autoloader 5-42

Mechanical System

(3) When having reassembled or replaced the sample compartment assembly (1) When having reassembled or replaced Auto-sampling

Front-back, left-

position

right, vertical

the sampling assembly (2) When having replaced the autoloader, or reassemble the autoloader's front or back supporting board assembly (1) When having reassembled or replaced

HGB bath pos.

Front-back,

the sampling assembly

vertical

(2) When having reassembled or replaced the HGB bath (1) When having reassembled or replaced

WNB bath pos.

Front-back,

the sampling assembly

vertical

(2) When having reassembled or replaced the WNB\DIFF bath (1) When having reassembled or replaced

DIFF bath pos.

Front-back,

the sampling assembly

vertical

(2) When having reassembled or replaced the WNB\DIFF bath (1) When having reassembled or replaced

RET bath pos.

Front-back,

the sampling assembly

vertical

(2) When having reassembled or replaced the RET bath (1) When having reassembled or replaced the sampling assembly

RBC bath pos.

Front-back, vertical

(2) When having replaced the horizontal home position sensor of the sampling assembly (3) When having reassembled or replaced the RBC bath

Note: check and confirm first, adjust the sample probe position if needed The positions of various reaction baths in the main unit are shown in the figure below:

5-43

Mechanical System

HGB bath DIFF bath WNB bath

RBC bath

RET bath

Figure 5-77 Positions of various reaction baths in the main unit Select Menu  Service  Debug & Self-Test  Adj. Sample Probe Pos. to enter the Adj. Sample Probe Pos. screen:

③

②

①

Figure 5-78 Path for entering the Adj. Sample Probe Pos. screen

5-44

Mechanical System

Check the saved steps of last adjustment

The tip moves to the last adjusted position for observation and debugging

The tip moves to the last adjusted position, start adjusting from the last adjusted position

The tip moves about 2 mm above the fixture, start adjusting from the default position

Restore factory configured position

Real work position

Figure 5-79 Adj. Sample Probe Pos. screen The probe wipe height-determining fixture is used to adjust the vertical direction home position, one end of the probe wipe height-determining fixture is 0.4mm longer than the other end. When adjusting the vertical direction home position, insert the probe wipe height-determining fixture into the probe wipe from the bottom, and adjust the sample probe position using the and buttons to make the longer end of the fixture touch the probe tip, while the shorter one can not touch.

Figure 5-80 Probe wipe height-determining fixture

5-45

Mechanical System

Figure 5-81 Operation method of probe wipe height-determining fixture When adjusting the sample probe position in the HGB bath, WNB bath, DIFF bath, RET bath, and RBC bath, you will use a fixture similar to the following figure: The front and rear direction of the sample probe should be within this area

The tip of the sample probe is flush with the surface

Step facade

Figure 5-82 Fixture for adjusting the sample probe position in the reaction bath Put the fixture into the round hole of the reaction bath to make the step facade face toward the right side of the main unit (be sure that the fixture should be flat and not to be topped by insulation wool or something else). Adjust the front-back, up-down position of the sample probe to make the probe align with the center of the round hole, and the probe tip is aligned with the lower step surface of the fixture.

5-46

Mechanical System

Figure 5-83 Adjusting the sample probe position in the reaction bath with fixture The adjusting fixture for the auto-sampling position is shown in the figure below. Remember to remove the floating blood barrier before adjusting. Otherwise, the fixture's cross-shape slot will not be found. The fixture is inserted into the analysis area from one side of the unloading tray towards the right, and the fixture should be tightly attached to the floating blood barrier bracket.

This facade closely contacts with the floating blood barrier bracket

The sample probe is flush with the center of the cross-shape slot The tip of the sample probe is flush with this surface

Figure 5-84 Fixture for adjusting the sample probe position at the auto-sampling position 5-47

Mechanical System

(2) Lower the blood barrier limit bracket

(3) Take out the blood barrier from the gap

(1) Insert a cross-head screwdriver into the hole to loosen this screw

When restoring, remember to raise the blood barrier limit bracket to the same height as the top surface of the blood barrier

Figure 5-85 Removal method of the floating blood barrier

Figure 5-86 Fixture operation method for adjusting the sample probe position at the auto-sampling position The fixtures for adjusting the CT-WB and CT-micro-WB positions are shown below. When placing the CT-micro-WB fixture, it is necessary to first remove the adapter at the CT-micro-WB position of the sample compartment assembly. When adjusting, align the sample probe with the center hole located on the fixture and align the probe tip with the upper surface of the fixture.

5-48

Mechanical System Adjusting fixture for the sample probe at the CT-WB position

Adjusting fixture for the sample probe at the CT-micro-WB position

Figure 5-87 Fixture for adjusting the sample probe position in the closed sample compartment One step of the sampling assembly horizontal motor equals 0.1626 mm, and one step of the vertical motor equals 0.04 mm. The following methods can be used for debugging if the fixture is not available: (1) Vertical direction home position Adjust the sample probe downward first until the probe tip is flush with the bottom of the probe wipe (you can feel it with your hand), and then move it upward 180 steps (7.2 mm) from this position. (2) WNB/DIFF/RET bath Tap the and buttons to align the sample probe with the center of the bath (visual inspection) first, then lower the sample probe until it is flush with the bath inlet (you can put a thin piece of paper on the bath inlet then adjust the tip until it touches the paper), and then move the sample probe upward 100 steps (4 mm) from this position. (3) HGB/RBC bath Disassemble the shield box of the HGB/RBC bath, and then adjust them using the same method with the WNB/DIFF/RET bath. (4) Auto-sampling position Before adjusting the auto-sampling position, it is recommended to remove the floating blood barrier in order to prevent the sample probe from pricking the floating blood barrier. Put a tube rack in the analysis area (note that the pinch roller is pressed in the groove of the tube rack), tap the and buttons to align the sample probe with the center of the tube rack tube position (visual inspection) , and then lower the sample probe to be flush with the top surface of the tube rack (you can put a thin piece of paper on the top of the tube rack then adjust the probe tip until it touches the paper), finally move the sample probe upward 975 steps (39 mm) from this position. (5) CT-WB sampling position Tap the and buttons to align the sample probe with the center of the CT-WB position (visual inspection), then lower the sample probe to be flush with the top of the sample compartment (you can put a thin piece of paper on the top of the sample compartment 5-49

Mechanical System

then adjust the probe tip until it touches the paper), and then move the sample probe upward 305 steps (12.2 mm) from this position. (6) CT-micro-WB position After adjusting the CT-WB sampling position, the U-D of the CT-micro-WB position can be adjusted to the same level as the CT-WB sampling position, and the F-B of the CT-micro-WB position are 123 steps more than that of the CT-WB sampling position.

5.2.6 Syringe Assembly Syringe motor

Syringe Home position photocoupler

Photocoupler barrier

Figure 5-88 Structure of ASP syringe (100uL) and SP syringe (250uL) ASP syringe assembly and SP syringe assembly have different motor models and syringe capacities, do not mix them together.

5-50

Mechanical System

Syringe motor

Syringe

Coupling

Home position photocoupler Lead screw

Figure 5-89 DIL Syringe (10mL) structure

5.2.7 Temperature Control Module The temperature control subsystem in the analyzer is used to heat the reagents such as diluents, lyses, and the assemblies such as reaction incubation baths, providing a suitable reaction environment for the analyzer reaction system.

5-51

Mechanical System

Figure 5-90 Exploded view of preheating bath structure

Figure 5-91 Explosive view of reaction bath assembly structure

5-52

Mechanical System

When the internal components of the preheating bath assembly and the reaction bath assembly are faulty, the entire assembly needs to be replaced in maintenance. The measurement assembly should be replaced using the modular design solution. 

Tools

NO.107 cross-head screwdriver 

Procedures

1

Make sure that the analyzer is powered off normally, and then pull out the power cord;

2

Fluidics exhaust;

3

Remove the components that need to be replaced;

4

screws need to be disassembled when replacing the preheating bath (refer to the left figure below); 8 screws need to be disassembled when replacing a set of reaction bath components (refer to the right figure below);

5-53

Chapter 6 Optical System 6.1 Fundamentals of Optical System The optical system uses a laser beam to irradiate reagent-treated blood cells through the flow cell, collecting forward scattered light, side scattered light, and lateral fluorescence from each blood cell. The forward scattered light reflects the volume information of the cell, the side scattered light reflects the internal nuclear and particle information of the cell, and the lateral fluorescence reflects the internal nucleic acid information of the cell. Through analyzing and processing the above three optical signals, the blood cells for the blood sample can be analyzed. The top view of the optical path of the analyzer's optical system is shown in the figure below: SFL Signal Output Laser drive board

FSC

Power

Fluorescent pre-amplification board

19

SSC

APD

Signal

Signal

18 1

17

Power

Fluorescent light collection assembly

20

Optical signal board

Side scattered light collection assembly Signal

3

Power

4

5

6

PD

Signal

14 13

Side scattered light collection system

Waste

15

16

PD 8 11

2

Beam control system

Flow cell

9

10 Forward scattered light collection assembly

7

Sheath fluid

12

Sample flow

Power Power supply system

Figure 6-1 Top view of optical path 1. Laser drive board

11. Forward light-suppressing diaphragm

2. Laser

12. Forward PD

3. Laser collimating lens

13. Lateral collection lens

4. Optical isolator

14 Dichroic mirror

5. Cylindrical len A

15. Lateral aperture diaphragm

6. Cylindrical len B

16. Lateral PD

7. Flow cell

17. Fluorescent aperture diaphragm

8. Radiation-proof diaphragm

18. Filter

9. Plano-convex lens

19 Fluorescent preamplification board

10. Lenticular lens

20. 6-1

Optical signal board

Optical System

The analyzer's optical system uses semiconductor laser (2) as the source of light. The laser drive board (1) provides power supply for the laser, which emits a red laser beam of 635nm. The laser beam passes through the collimating lens (3) and gets collimated, and passes the optical isolator (4), then it is adjusted by cylindrical lens A (5) and B (6) which are placed orthogonally, to form a flat elliptic laser beam going through the sample flow in the center of the flow cell (7).

Figure 6-2 Laser spot through the flow cell Blood cells treated with lyse and fluorescent reagents are wrapped by a sheath fluid that forms a hydrodynamic focusing phenomenon at the flow cell, which in turn passes through the flow cell as shown in Figure 6-2. The flat elliptic laser beam irradiates light on each blood cell passing through the flow cell, excites scattered light and fluorescence, and direct light that has not been scattered by the cell is blocked by the radiation-proof diaphragm (8). The 1~10° forward scattered light passes through the radiation-proof diaphragm, and is collected via a Plano-convex lens (9) and a lenticular lens (10), and then passes through a forward light-suppressing diaphragm (11). It converges on the forward PD (12) to form a forward scattered signal. Both side scattered light and side excited fluorescence are collected by the lateral collection lens (13); and then separated by a dichroic len (14): the side scattered light with a stable wavelength is reflected by the len; and the side excited fluorescence, with its wavelength becoming longer, passes through the len. Side scattered light converges on the lateral PD (16) via a light-suppressing diaphragm (15) to form a side scattered signal; side excited fluorescence passes through the fluorescent light-suppressing diaphragm (15) and the long-pass filter (18) to further filter the side scattered light and converges on the Si-PMT on the fluorescent preamplification board (19) to form a fluorescent signal. The three channels of optical signals are further amplified and processed by the optical signal board (20), and then are uploaded to the analyzer signal processing system to form a scattergram.

6-2

Optical System

6.2 Composition of the Optical System Remove the upper cover of the analyzer's optical system insulation box. The assemblies are shown in the figure below.

Figure 6-3 Optical system assemblies 1. Optical lateral cover assembly

8. Lateral PD assembly

2. Front optical assembly

9.Fluorescent

preamplification

board

assembly 3. Flow cell assembly

10. Optical signal board

4. Rear collection assembly

11. NTC nut

5. Forward PD assembly

12. Optical base plate assembly

6. Lateral collection assembly

13. Optical upper cover assembly

7. Dichroic len assembly The front optical module (2) has a semiconductor laser (635 nm), a collimator lens, optical isolator, cylindrical len A, and cylindrical len B. The laser drive board on the optical lateral cover assembly (1) provides a stable current input to the front optical assembly, and the front optical assembly is responsible for irradiating the shaped laser beam to the flow cell detection area. The flow cell assembly (3) includes a flow cell and a rectifying assembly, and creates a fluid state in the flow cell where the stable sheath fluid wraps the sample flow. The reagent-treated cells in the laser irradiation flow cell excite scattered light and fluorescence. The rear collection assembly (4) includes a radiation-proof diaphragm, a Plano-convex lens, and a lenticular lens. The 1~10° forward scattered light emitted by the cells converges on the PD photosensitive surface of the forward PD module (5). The lateral collection assembly (6) has a lateral collection lens near the flow cell, and the lens can be slightly adjusted in three dimensions to ensure the collection and convergence of side scattered light and fluorescence, which are then respectively 6-3

Optical System

reflected and transmitted by the dichroic mirror assembly (7). The side scattered light converges to the photosensitive surface of the lateral PD assembly (8). The fluorescent signals transmitted through the dichroic mirror converge at the diaphragm of the fluorescent aperture in the fluorescent preamplification board assembly (9) and reach the photosensitive surface of SiPMT after passing the filter. The above three channels of signals are transmitted to the optical signal board (10) at the same time, so as to further amplify and process the blood cell scattering signal, and then the signal is uploaded to the analyzer signal processing system, and finally a scattergram is formed. The optical assembly are all mounted on the base plate assembly (12), and a heating membrane is installed under the base plate assembly to perform overall temperature control of the optical system. The entire optical system is provided with an insulation box to shield outside light, heat, vibration, electromagnetic field and dust.

6-4

Optical System

6.3 Troubleshooting Optical Faults 6.3.1 Scattergram Abnormal 

Tools

NO.107 cross-head screwdriver 

Consumables

4k-07 standard particle (7um), calibrator, 1.5mL centrifuge tube, microfiber dust cloth, anhydrous alcohol 

Note

Many factors may cause abnormal scattergrams. Follow below steps to locate the problem. 1.

First, check whether the analyzer reports error. If so, remove the error. When the analyzer does not report any error, but the scattergrams are abnormal: first check whether all the 3 scattergrams (DIFF, RET and WNB) are abnormal. If only one of Themis abnormal, most probably the problem is not within the optical system. Check for the fluidic system, reagents system or temperature control system instead. (There are rare cases that when not all 3 scattergrams (DIFF, RET and WNB) are abnormal, and the fluidic system, reagent system, and temperature control system are OK too. Go to the next step to perform optical system investigation.)

2.

If all the 3 scattergrams are abnormal, it is most likely that the optical system is abnormal. Log in to the main unit with the service level account and click "Menu → Service → Debug & Self-Test→ Optical Debug” to enter the optical debug screen.

3.

Gently mix the 4k-07 standard particle vials, and add 4 drops of 4k-07 standard particles to 1 mL of deionized water, so as to prepare a standard particle sample.

4.

Place the standard particle sample under the sample probe and press the Aspirate key to run the standard particle sample. After the count is completed, the scattergrams of the standard particle sample will be automatically displayed. Note that the total of particles should be greater than 1000; if not, dispense more standard particles into the centrifuge tubes and run it again.

5.

The WNB and DIFF channels’ CV and optical background voltage values of Table 6-1 the 4k-07 standard particles counting results FS and SS should be within the range shown in , and the WNB and DIFF channels’ Gravity Center Pos. of FS and SS should also be within their ranges. Table 6-1 4k-07 standard particle CV range Items

Acceptance Criteria WNB

FS DIFF

Center of gravity

480.00~615.00

CV

≤2.5%

Center of gravity

480.00~615.00

CV

≤3.2% 6-5

Optical System

WNB SS DIFF

Center of gravity

998.0~1350.0

CV

≤19.0%

Center of gravity

998.0~1350.0

CV

≤19.0%

Forward optical background voltage

≤100mv

Total number of particles

1000~6000

6.

If the CV, blank count and the center of gravity all meet the requirements as in Table 6-1, but the blood sample scattergrams are still abnormal, then the optical system is OK. Check the fluidic system, reagent system, or temperature control system.

7.

If the CV and the blank count meet the requirements as in Table 6-1 but the center of gravity does not, perform the optical gain calibration in accordance with the instruction in the “Optical Gain Calibration” section.

8.

When either CV or the blank count does not meet the requirements in Table 6-1, the problem may be caused by a dirty flow cell.

9.

Click "Menu → Service → Maintenance" to enter the maintenance screen, click "Flow cell" button in the "Probe Cleanser Maint." area, and then follow the software instruction to perform probe cleanser maintenance to the flow cell (the purpose is to eliminate impurities on the internal wall of the flow cell, which always cause high blank count).

10. After that, click "Menu → Service → Cleaning" to enter the cleaning screen, click the "Flow Cell Flush" button to perform flow cell flushing, and then do 4k-07 standard particles test to confirm whether the scattergrams are improved. If the scattergram quality is not improved or still not good enough, repeat steps 9) to 10). If still not improved, do as follows (below procedure mainly intends to eliminate impurities attached to the exterior wall of flow cell. If the exterior wall is dirty, you can often see bright glitter on the surface of the flow cell). 11. Use a cross-head screwdriver to remove the top and right panels of the main unit, and the top cover of the optical system insulation box. 12. Wipe the surface of the flow cell with a clean, lint-free cloth and absolute alcohol. Check whether there is reagent leakage in the tube to the flow cell during wiping. If the tube is damaged and the reagent leaks to contaminate the surface of the flow cell, replace the tube. After that, restore the upper cover of the insulation box, and do 4k-07 standard particles and fresh blood test to confirm the effect. 13. If it does not work, replace the optical system. Note Laser radiation. ESD protection. Do not perform any counting operation when the top cover of the insulation box is not properly secured, otherwise the PMT is easily damaged.

6-6

Optical System

6.3.2 Laser Diode Current Abnormal 

Equipment

Multimeter 

Tools

NO.107 cross-head screwdriver 

Note

1.

Click Service - Debug & Self-Test - Laser Diode Debug to enter the laser diode debug screen.

2.

Check the “Optical system temperature” on the software screen. If the temperature is within the range, tap “Test” to start laser diode debugging. (When the temperature is out of range, address the “Optical system temperature abnormal” error.)

3.

After debugging, check the laser diode current again: 

When the current is within the range, tap “Save”, and end the debugging.



When the current is higher than 0mA, but is not within the range, replace the optical system;



When the current is at 0 mA, follow below instruction to check the wire connected to the laser diode:

(1) Power off the analyzer, disconnect the power cord. (2) Wear a pair of clean disposable rubber gloves to protect yourself from electrostatic damage; 6-7

Optical System

(3) Use a cross-head screwdriver to remove the top and right panels of the main unit, and the top cover of the optical system insulation box. (4) Check whether the laser diode wire connector is loose. If the laser cable is disconnected, replace the wire and install the top cover of the insulation box on the optical system. (5) Restart the analyzer to check if there is an error. If the laser diode current is still abnormal, replace the optical system. Note Laser radiation. ESD protection. Do not perform any counting operation when the top cover of the insulation box is not properly secured, otherwise the PMT is easily damaged.

6.3.3 When the Optical Gain Cannot be Calibrated If you have performed the optical gain calibration for several times, and the optical gain is still not in range, then the optical gain cannot be calibrated. 

Tools

NO.107 cross-head screwdriver 

Note

1. Make sure that the laser diode current is within the normal range; if it is abnormal, start the laser diode current troubleshooting according to section 6.3.2 ; if it is normal, perform the next step. 2. Make sure that the analyzer is shut down and powered off, and the plug is pulled out. 3. Wear a pair of clean disposable rubber gloves to protect yourself from electrostatic damage; 4. Use a cross-head screwdriver to remove the top and right panels of the main unit, and the top cover of the optical system insulation box. 5. Replace the front optical signal board and check the wires to make sure they are in place. 6. Perform a cleaning sequence after power-on, and perform optical gain calibration again. If the calibration is still not possible, replace the optical system. Note Laser radiation. ESD protection. Do not perform any counting operation when the top cover of the insulation box is not properly secured, otherwise the PMT is easily damaged. Make sure that all the cables connected to the pre-amplification board are OK.

6-8

Optical System

6.3.4 Maintenance and Replacement of Optical System Optical system maintenance 

Probe cleanser maintenance



Flow cell flushing



Analyzer cleaning



Flow cell exterior wall cleaning

Optical system FRU 

Main replaceable components of the optical system include the laser control board and its connecting cables, the optical signal board and its connecting cable.



Before the replacement, you need to shut down the analyzer and do ESD protection.



After replacing the corresponding assembly, turn on the analyzer, perform a cleaning sequence, and then enter the Optical Debug screen. Perform steps (2) to (5) in section 6.3.1 to further confirm that the analyzer meets the requirements in Table 6-1.

Optical system replacement procedure and precautions 1

Pull out the cables, optical system cable, flow cell connecting tube, and waste box connecting tube at the top of the analyzer that will affect the opening of board-fixing sheet metal;

2

As shown in Figure 6-4: Fix a new set of optical system to the main unit with the 6-M3x12 cross-recessed pan head screws (torque requirement is 4-6kfgcm); connect the base plate heating wire, optical base plate overheat protection switch wire to the back optical system; connect the optical temperature sensor connection wire; insert the optical system signal wire into the main control board J2, insert the optical system control wire into the main control board J4, insert the optical system power supply wire into the analog board J7, insert the laser control board connection wire into the main control board J3 and analog board J1 socket; reconnect the wire that has been previously pulled out due to affecting the opening of the fixing plate; fix the main control board assembly to the top cover of the main unit with the 2-M4x8 cross-recessed pan head combination screw (diagonal position, torque requirement is 6-8kfgcm).

6-9

Optical System

Figure 6-4 Assembly procedure for replacing optical system

光学系统控制线 连接于母板J6

Optical base plate overheat protection switch cable connects to socket J4 on the motherboard

Optical system temperature sensor

Optical system control cable connected to J6 on motherboard

Optical system signal cable connected to J7 on motherboard

Figure 6-5 Amplification diagram of connecting optical system wires 6-10

Optical System

3

Connect the flow cell and waste box tubing as shown below;

Figure 6-6 Flow cell and waste container tubing

Note Laser radiation. ESD protection. Do not perform any counting operation when the top cover of the insulation box is not properly secured, otherwise the PMT is easily damaged. Make sure that the optical system cable and flow cell tubing are connected correctly and securely. 4

After installing the optical system, start the analyzer, and tap “Service”-“Debug&Self-test”“Laser Diode Debug” to enter the “Laser Diode Debug” screen.

5

Check for the optical system temperature. When its value is within the range, tap “Test” to start laser diode debug. (When the temperature is out of range, address the “Optical system temperature abnormal” error.)

6

When the test completes, check whether the laser diode drive current falls into the allowed range. 6-11

Optical System



If it is within the range, tap “Save” and end the debugging.



If it is out of the range, follow the instruction in 6.3.2 Laser Diode Current Abnormal to troubleshoot the problem. If it is within the range, tap “Save” and end the debugging.

6.3.5 Replacing Optical Assembly after Analyzer Upgrading with the New Optical Assembly and New Optical Signal Board (After EIV013) All the analyzer produced after EIV013 uses the high-end optical assembly (new optical assembly). Table 6-2 Notes on the new and old optical assemblies PN

Matching

optical

Notes

signal board New

optical

115-062790-00

assembly Old

optical

115-044092-00

assembly

New optical signal

Use the new optical

board （051-002779-

signal

02）， blue

with the new optical

Old

optical

signal

board

only

assembly, and the

board （ 051-002779-

old

00）， green

board only with the

optical

old

signal optical

assembly. When you need to replace the problem optical assembly with a new optical assembly, follow below instruction: 1. Check the analyzer main unit software version. If the software version is below that of EIV013, update the software to the newest version. When you cannot remember the exact software version of EIV013, you can check the information using the following method: Tap Menu-“Service”-“Advanced Toolbox”-“System Configuration”, and check the “Other Configuration” area. If you can see the “With new optical assembly” option, the analyzer is at least with the EIV013 configuration.

6-12

Optical System

2. Make sure “With new optical assembly” is selected on the “Service”-“Advanced Toolbox”-“System Configuration” screen. 3. Repalce the optical assembly. 

Special Situation

When under certain special circumstances, you need to replace the optical assembly with an old optical assembly (“before EIV013” version), follow below instruction. 1. Check the analyzer main unit software version. (See the instruction in Step 1 of above section) 2. Replace the optical assembly. 

If the software version is before the EIV013 version, you can replace the optical assembly directly; or you can first upgrade the software to the newest version, but make sure the “With new optical assembly” option on the “Service”-“Advanced Toolbox”-“System Configuration” screen is not selected.



If the software version is the EIV013 version or after the EIV013 version, tap Menu“Service”-“Advanced Toolbox”-“System Configuration”, and make sure the “With new optical assembly” option is not selected.



Replacing the new optical signal board

Use the new optical signal board only with the new optical assembly, and the old optical signal board only with the old optical assembly (see .Table 6-2).

6-13

Chapter 7 Fluidics System 7.1 Fluidics System Overview The analyzer uses multi-section sample distribution method. The sample is dispensed into each channel in sequence after being aspirated into the probe. The procedure is shown as follows:

Figure 7-1 Sample probe dispensing sample procedure The sample will be incubated and measured in each channel individually after being dispensed. The HGB channel measures samples using the colorimetric method, the WNB, DIFF, and RET channels measure samples using the optical scattering sheath flow method, and the RBC channel uses the impedance method. The measurement principle is shown below:

7-1

Fluidics System

20uL 20uL 20uL

Flow cell LR lyse

LD Lyse LB Lyse

LD lyse

LB lyse

DR diluent

1mL

1mL

1mL

DIFF reaction bath 1：54

20uL

Sheath fluid heating bath

WNB reaction bath 1：69

15uL

RET reaction bath 1：266

4uL

Dispense blood segments

FCM bath

250uL syringe LH lyse

Diluent

Diluent

0.52mL

1.5mL

25uL

Dispense blood segments 6uL

HGB reaction bath 1：339

RBC count bath 1：20000

2mL

Figure 7-2 Measurement principles for various channels

7-2

Fluidics System

7.2 Measurement Flow Whole Blood

Test channel

RBC/PLT

HGB

Measurement Channel

RBC/PLT Channel

HGB

Test method

RBC/PLT Channel

HGB

Flag Message

PLT histogram

PLT

Parameters

WBC/RET

4DIFF Channel

MPV

RBC

4DIFF Scattergram

HGB

Lymph%

Mono%

Neut%

Eosi%

WNB Scattergram

RET Scattergram

Lymph#

Mono#

Neut#

Eosi#

NRBC% BASO%

WBC#

RET% RET# PLT-O

MCV RDW-SD

PDW

MCH RDW-CV

P-LCR

Reagents

RET Channel

WBC/RET

RBC histogram

HCT

WNB Channel

NRBC# BASO#

MCHC

M-60 Diluent

LD Lyse

LN Lyse

DR Diluent

LD fluorescent reagent

LN fluorescent reagent

DR fluorescent reagent

LH Lyse

Figure 7-3 Measurement Flow 7-3

LFR MFR HFR IRF

Fluidics System

7.3 Sample Dilution Flow Chart 7.3.1 Whole blood mode RET 4uL RET bath 1:266

DR 1040uL + FR 20uL

WNB 15uL WNB bath 1:69

LN 1000uL + FN 20uL Whole blood sample DIFF 20uL

DIFF bath 1:54

LD 1040uL + FD 20uL

LH 520uL

HGB 6uL

HGB (before lysing) 1:251

DIL 1500uL

Second aspiration 25uL

RBC 1:20000

DIL 1975uL

Figure 7-4 Whole blood sample dilution flow chart

7-4

HGB 1:339

Fluidics System

7.3.2 Prediluted mode RET 8uL RET bath 1:801

DR 1040uL + FR 20uL

WNB 25uL

Manually diluted sample 1:6

WNB bath 1:251

LN 1000uL + FN 20uL

DIFF 30uL DIFF bath 1:218

LD 1040uL + FD 20uL

LH 520uL

HGB 8uL

HGB (before lysing) 1:1131

DIL 1500uL

Secondary aspiration 80uL

RBC 1:28125

DIL 1975uL

Figure 7-5 Prediluted Sample dilution flow chart

7-5

HGB 1:1543

Fluidics System

7.4 Sample Volume Table 7-1 Sample volume Inspection

Whole blood

Micro-WB

Item

mode

mode

64.5L

30L

RET sample

4L

4L

8uL

HGB sample

6L

6L

8uL

WNB sample

15L

6L

25uL

DIFF sample

20L

6.5L

30uL

25uL

25L

65uL

Aspiration capacity

RBC diluted sample

7-6

Prediluted mode Manual dilution: 20uL blood sample and 100uL diluent; aspirate 83L

Fluidics System

7.5 Time of Preparation and Measurement Table 7-2 Time of Preparation and Measurement Channel Time of Preparation Time of Measurement

WNB

DIFF

RET

HGB

RBC

channel

Channel

Channel

Channel

Channel

≤10s

≤21s

≤46.5s

≤5.3s

≤9s

6s

6s

4s

/

10s

7-7

Fluidics System

7.6 Temperature Control for Fluidics System Table 7-3 Temperature Control for Fluidics System Inspection Item Target temperature (℃) Alarm temperature (℃)

Multi-channel diluent

Optical

Reaction

preheating bath

system

bath

32

32

42

±3

+6/-2

±3

7-8

Fluidics System

7.7 Reagent Consumption Volume The consumption volumes of various reagents in measurement mode are as follows (unit: mL): Table 7-4 Reagent consumption volume Scenario

Name

Diluent

HGB

DIFF

RET

WNB

Channel

Channel

Channel

channel

DIL

LH

LD

FD

DR

FR

LN

FN

Continuous

WB CBC

40

1.04

0

0

0

0

1.5

0.02

measurement

WB CD

40

0.52

1.56

0.02

0

0

1.5

0.02

WB CDR

55

0.52

1.56

0.02

1.56

0.02

1.5

0.02

WB CR

50

1.04

0

0

1.56

0.02

1.5

0.02

WB RET

50

1.04

0

0

1.56

0.02

1.5

0.02

Micro-WB CBC

45

1.04

0

0

0

0

1.5

0.02

Micro-WB CD

50

1.04

1.56

0.02

0

0

1.5

0.02

Micro-WB CDR

60

1.04

1.56

0.02

1.56

0.02

1.5

0.02

Micro-WB CR

55

1.04

0

0

1.56

0.02

1.5

0.02

Micro-WB RET

55

1.04

0

0

1.56

0.02

1.5

0.02

PD CBC

45

1.04

0

0

0

0

1.5

0.02

PD CD

50

1.04

1.56

0.02

0

0

1.5

0.02

PD CDR

60

1.04

1.56

0.02

1.56

0.02

1.5

0.02

PD CR

60

1.04

0

0

1.56

0.02

1.5

0.02

PD RET

60

1.04

0

0

1.56

0.02

1.5

0.02

OV enters shallow sleep (1H~3H)

1

0

0

0

0

0

0

0

Sleep

7-9

Fluidics System

Mode switch

Startup/shutdown

OV exits shallow sleep (1H~3H)

6

0.52

0

0

0

0

0

0

CT-AL enters shallow sleep (1H~3H)

0

0

0

0

0

0

0

0

CT-AL exits shallow sleep (1H~3H)

6

0.52

0

0

0

0

0

0

Enter deep sleep (3H~24H)

0

0

0

0

0

0

0

0

OV exits deep sleep (3H~24H)

120

5.2

3.12

0.06

3.12

0.06

3

0.06

CT exits deep sleep (3H~24H)

120

5.2

3.12

0.06

3.12

0.06

3

0.06

AL switches to CT

0

0

0

0

0

0

0

0

CT switches to AL

0

0

0

0

0

0

0

0

AL switches to OV

2

0

0

0

0

0

0

0

OV switches to AL

1

0

0

0

0

0

0

0

CT shutdown (routine shutdown every

145

0.52

1.56

0.06

0

0

3

0.06

RET

145

0.52

1.56

0.06

2.6

0.06

3

0.06

OV shutdown (routine shutdown every

140

0.52

1.56

0.06

0

0

3

0.06

140

0.52

1.56

0.06

2.6

0.06

3

0.06

Startup 1 (normal)

120

5.2

3.12

0.06

3.12

0.06

3

0.06

Startup 2 (abnormal)

240

10.4

6.24

0.12

6.24

0.12

6

0.12

Replace DIL

16

0

0

0

0

0

0

0

Replace LH

0.016

12.48

0

0

0

0

0

0

Replace LN

0.016

0

0

0

0

0

12

0.04

Replace LD

0.016

0

12.5

0.04

0

0

0

0

day) CT

shutdown

(accumulative

modes > 200) day) OV shutdown 4 (accumulative RET modes > 200)

Replace reagents

7-10

Fluidics System

Replace DR

0.003

0

0

0

12.5

0.04

0

0

Replace FN

3

0

0

0

0

0

0

0.84

Replace FD

3

0

0

0.84

0

0

0

0

Replace FR

3

0

0

0

0

0.84

0

0

7-11

Fluidics System

7.8 Fluidic Parts and Functions 7.8.1 Sample probe The sample probe is used to aspirate and dispense samples, move between each incubation bath through horizontal and vertical motors to dispense samples.

7.8.2 Probe Wipe The probe wipe is used to provide a cavity to clean the exterior walls of the sample probe using the liquid flow; and collect the waste produced by cleaning the interior walls.

7.8.3 Pumps 

Air pump (P1): provides pressure for the pneumatic system. It provides 120kPa and N40kPa pressure chambers directly to build the pressure.



Waste pump (P2): Collects probe wipe waste



Waste pump (P3): Drains WC1



Dosing pumps: meter the output of the reagent device. There are 11 dosing pumps set in the analyzer, and their functions are shown below: 

DP1~DP4 are used to quantitatively output DR, LD, LN, and LH reagents respectively;



DP5 and DP6 are used to quantitatively output the diluent to the RBC channel and HGB channel respectively;



DP8 is used to buffer the DIL bath during the filling process;



DP9~DP11 are used to quantitatively output FR, FD, and FN reagents respectively.

Figure 7-6 Dosing pump symbol

7-12

Fluidics System

Liquid chamber connector

Air cell connector

Figure 7-7 Dosing pump appearance

7.8.4 Syringe 

Aspiration syringe (Asp-Syringe): the full range is 100μl, quantitatively aspirates and dispenses the blood sample, and aspirates the secondary diluted sample.



Dilution syringe (Dil-Syringe): the full range is 10ml, pours the diluent into the FCM bath;



Sample injection syringe (Sp-Syringe): the full range is 250uL, pours the sample fluid into the flow cell to form a stable sample flow through working with the sheath fluid.

The syringe symbol is shown in the figure below.

Figure 7-8 Syringe symbol

7.8.5 Valves 

Mindray valves 

Two-way valve: to build up or cut off a passage. When power off, the passage from the inlet of the valve to outlet is cut off; when power on, the passage is build up.



Three-way valve: to switch among passages. When power off, the public end and the NO (normally open) end are connected; when power on, the public end and the N.O.(normally open) end are connected.



Note: the operating voltage of Mindray valves is 12V, and maximal bearable pressure is 200KPa. The internal movement of the valves is driven by electromagnet and the 7-13

Fluidics System

restoration is driven by the spring, so it is recommended not put the valves power-on for too long. When the electromagnet valve is working, the spring pole will lower down, and it will rise to the initial position when power off. You can touch the spring pole and feel the descending or ascending, in order to determine whether it is in action.

Figure 7-9 Symbols of two-way Mindray valve (left) and three-way Mindray valve (right)

Spring pole

Figure 7-10 Appearance of two-way Mindray valve (left) and three-way Mindray valve (right) 

Two-way/Three-way pressure proof Mindray valve 

Function: The two-way pressure proof Mindray valve has higher reserve pressure resistance compared with the ordinary two-way Mindray valve, while its operating principle is the same as that of the ordinary Mindray valve. The three-way pressure proof Mindray valve has higher reserve pressure resistance at the NC end compared with the ordinary three-way Mindray valve, while its operating principle is the same as that of the ordinary Mindray valve.



Note: when replacing valves, carefully distinguish ordinary two-way/three-way Mindray valves from pressure-proof valves. In the fluidics diagram, the pressure proof valve has the same symbol as the Mindray valve.

7-14

Fluidics System

Two-way/Threeway pressureproof Mindray valve

Two-way Mindray valve

Figure 7-11 Two-way/Three-way pressure proof Mindray valve 

LVMK two-way/three-way valve 

Function: LVMK two-way/three-way valve has the same function as the twoway/three-way Mindray valve, but the valve pump's working volume and pressure deformation are better than the Mindray valve. It is mainly used for sampling tubing and pipelines with high quantitative requirements.

Figure 7-12 LVMK two-way/three-way valve 

LVM valve of 20uL dosing pump 

Function: works with the 20ul dosing pump, dispensing the fluorescent dyes from the reagent bag in the optical reaction bath.



Note: the maximal bearable pressure of the LVM fluidic valve is 200KPa, and the CV of the flow is about 0.03.

Figure 7-13 LVM valve of 20uL dosing pump 7-15

Fluidics System



Check valve 

Function: only allow one-way flow of gas or liquid. Only allow gas or liquid to flow from A to B (B to A is not allowed).



Note: be aware of the direction of flow for the check valve (as indicated by the arrow in the figures above).

Figure 7-14 Symbol and appearance of check valve



Pinch valve 

Function: opens and closes the pipeline by clamping and releasing the hose using compressed gas as the power.



Note: when removing and installing the pinch valve, 120kPa positive pressure must be released first.

Figure 7-15 Appearance of pinch valve

7.8.6 Baths 

WNB bath, DIFF bath and RET bath: provide optical channel sample reaction place. The bath body has the temperature control function and can achieve constant temperature incubation.



RBC bath: consists of front bath, back bath and an aperture. It is where the RBC sample is mixed for analysis; supports the measurement of RBC/PLT.



HGB bath: provides HGB channel sample reaction place for HGB colorimetric analysis. 7-16

Fluidics System

7.8.7 Filters 

Waste filter LF1: filters impurities from the WC1 to protect the waste pump P3



Probe wipe filter LF2: filters impurities from the probe wipe to protect the waste pump P2;

Waste filter

Probe wipe filter

Figure 7-16 Appearance of probe wipe filter and waste filter 

Diluent filter LF3: filters impurities from the FCM bath to protect the optical channel;

Figure 7-17 Diluent filter 

Sheath fluid filter LF4: blocks tiny bubbles in the FCM channel.

7-17

Fluidics System

Figure 7-18 Appearance of sheath fluid filter

7.8.8 Liquid Pressure Detection Components 

Sampling pressure sensor LPS: collects the pressure condition of the sampling tubing for sampling abnormal flags.



Pressure sensors PS1~PS6: monitor the pressure in the pressure tank for the pressure feedback during the pressure build-up process.

7-18

Fluidics System

7.9 Pneumatic System 7.9.1 Pneumatic System Introduction P1

OPEN

OPEN

OPEN

120KPa SV61

SV62

SV60 PS6

SV64

PS1

PS5

SV65 PS3 PS2

GC-120KPa 600mL

GC-50KPa 600mL GC-N40KPa 600mL

GC-90KPa 600mL

SV63

50KPa

90KPa

N40KPa

Waste f rom the pressure flowing tubes

7.9.2 Introduction of Pneumatic Parts and Functions 

Air pump P1: provides the pressure for the entire pneumatic system.



Pressure chamber GC-120kPa: stores the 120kPa compressed gas to provide the pressure for the pinch valve, and fills the pressure for the 90kPa, 50kPa pressure tank;



Pressure chamber GC-90kPa: stores the 90kPa compressed gas to provide the stable pressure for the FCM bath, which is used to outputting the sheath fluid for the optical measurement;



Pressure chamber GC-50kPa: stores 50kPa compressed gas to provide fluid power for the various dosing pumps and DIL cistern;



Vacuum chamber GC-N40kPa: stores -40kPa compressed gas to provide the vacuum power for the WC1 and RBC analysis.



Pressure sensors PS1~PS6: monitor and feed back the pressure of each air reservoir.

7-19

Fluidics System

7.10 Fluidic Channels and Fluidic Structure 7.10.1 WNB Channel DT SV26

SV48

SV58

LN DP01 DP11 20uL FN DYE bag SV27

50kPa N40kP a

WNB

DIFF RH 2

DIFF

WNB

LN reagent container

RET RH 2

RH 3

RET

SV18

DP3 1.0mL

SV14

PV02/SV75 SP_SYRINGE

SV36

WC1-O

WC2-S

50kPa

SV33

SV44

WC1-N

SV08

PV01/SV74

OPEN

50kPa

FC

Figure 7-19 WNB measurement channel Process description: the M-6 LN LYSE is aspirated from the LN cistern and dispensed into the WNB preheating bath by DP3 (1mL), bringing the preheated LN LYSE into the WNB bath. The lyse first lyses the normal red blood cells, and then perforates other cells. The FN DYE is then dispensed into the WNB bath by DP11 (20uL), and combined with the nucleic acid in white blood cells or nucleated red blood cells. The solenoid valve SV08 controls the 50kPa pressure to bubble during the whole process (referred to as incubation process) to facilitate the reaction. After incubation, the sample is pushed by the vacuum of WC1 to go through pinch valves PV02 and PV01, and then aspirated into the sample preparation tubing. The syringe then pushes the sample to go to the flow cell. Wrapped by the sheath fluid, the sample flow goes through the flow cell while the optical system starts to identify the cells passing through the flow cell. These signals will then be analyzed and processed to get the WNB scattergram. After the measurement, the analyzer will clean the flow cell and downstream tubing with diluent, and the syringe will restore to the initial status, getting ready for the measurement of next channel (DIFF).

7-20

Fluidics System

7.10.2

DIFF Channel DT

SV47

SV57

LD

FD Dye bag

SV25

50kPa N40kPa

WNB

DIFF RH 2

WNB

LD reagent container

RET RH 3

RH 2

RET

SV17

DIFF

DP01 DP10 20uL

DP2 0.5mL

SV13

PV03/SV76

SV07

SP_SYRINGE

WC1-O

WC2-S

50kPa

SV36

SV43

WC1-D

PV01/SV74

SV33

OPEN

50kPa

FC

Figure 7-20 DIFF measurement channel Process description: the LD LYSE is aspirated from the LD cistern and dispensed into the DIFF preheating bath by DP2 (0.5mL), bringing the preheated LD LYSE into the DIFF bath. The lyse first lyses the normal red blood cells, and then perforates the white blood cells. The FD DYE is then dispensed into the DIFF bath by DP10 (20uL), and combine with the nucleic acid in the white blood cells. The solenoid valve SV07 controls the 50kPa pressure to bubble during the whole process (referred to as incubation process) to facilitate the reaction. After incubation, the sample is pushed by the vacuum of WC1 to go through pinch valves PV03 and PV01, and then aspirated into the sample preparation tubing. The syringe then pushes the sample to go to the flow cell. Wrapped by the sheath fluid, the sample flow goes through the flow cell while the optical system starts to identify the cells passing through the flow cell. These signals will then be analyzed and processed to get the DIFF scattergram. After the measurement, the analyzer will clean the flow cell and downstream tubing with diluent, and the syringe will restore to the initial status, getting ready for the measurement of next channel (RET).

7-21

Fluidics System

7.10.3

RET Channel DT

SV46

SV56

DR DP01 DP9 20uL FR DYE bag SV24

50kPa N40kPa

WNB

DIFF RH 2

RH 3

RH 2

DIFF

WNB

DR reagent container

RET RET

SV16

DP1 0.5mL

SV13

PV04/SV77 SP_SYRINGE

WC1-O

WC2-S

50kPa

SV36

SV38

WC1-R

SV06 PV01/SV74

SV33

OPEN

50kPa

FC

Figure 7-21 RET measurement channel Process description: the DR DILUENT is aspirated from the DR cistern and dispensed into the RET preheating bath by DP1 (0.5mL), bringing the preheated DR DILUENT into the RET bath. The DR diluent first spherizes the cells. The FR DYE is then dispensed into the RET bath by DP9 (20uL), and combined with the reticulocyte and the nucleic acid in the white blood cells. The solenoid valve SV06 controls the 50kPa pressure to bubble during the whole process (referred to as incubation process) to facilitate the reaction. After incubation, the sample is pushed by the vacuum of WC1 to go through pinch valves PV04 and PV07, and then aspirated into the sample preparation tubing. The syringe then pushes the sample to go to the flow cell. Wrapped by the sheath fluid, the sample flow goes through the flow cell while the optical system starts to identify the cells passing through the flow cell. These signals will then be analyzed and processed to get the RET scattergram. After the measurement, the analyzer will clean the flow cell and downstream tubing with diluent, and the syringe will restore to the initial status.

7-22

Fluidics System

RBC/PLT Channel

50kPa

RH1RBC

N40kPa

7.10.4

SV66 VC

TS1 SV30 DIL RBC SV32 VC-N30KPa 180mL

DP6 2.0mL

SV69 ICF1

SV12

50kPa

OPEN

T52

SV35 SV05

DP8 8mL

SV42

OPEN 50kPa

50kPa

WC1-RC

WC1-VC

SV67

SV41

Figure 7-22 RBC measurement channel Process description: The dosing pump DP06 (2mL) pushes the diluent in the DIL bath into the HGB bath, dispense the 25uL secondary dilution sample with the sample probe, bubble and mix the sample. The mixed sample passes through the aperture and generates a corresponding pulse signal under the vacuum of the VC bath.

7-23

Fluidics System

7.10.5

HGB Channel DT SV49

N40kPa

50kPa

LH

SV66

SV23

RH1HGB

LH reagent container

HGB SV29

SV28 DIL

DP4 0.5mL

DP5 1.5mL SV11 SV69

OPEN

DP8 8mL

OPEN

50kPa

50kPa

SV14

SV45

WC1-H

OPEN 50kPa

SV67

50kPa

SV09

Figure 7-23 HGB measurement channel Process description: The dosing pump DP05 (1.5mL) pushes the diluent in the DIL bath into the HGB bath; the dosing pump DP04 (0.52mL) pushes the LH lyse into the HGB bath. Then the sample is mixed by small bubbles. Place the well-mixed sample in still for a while and then obtain the measurement voltage. Since the blank voltage of the sample is attained before the measurement, the HGB can be calculated based on the colorimetric equation.

7-24

Fluidics System

7.11 Introduction to Sequences Taking the CBC+DIFF+RET analysis in the CT-WB mode as an example:

7.11.1

CT-WB Analysis Sequences

0~12s: as shown in the figure below The sample probe moves to the CT-WB position. The sampling tube builds vacuum through closing SV55 and opening SV54. When it is ready, the ASP syringe performs whole blood sample aspiration through the ASP syringe after the preparation. Clean the sample probe after piercing; Drain the RET bath, HGB bath, WNB bath, DIFF bath, RBC bath; Dispense 0.5ml RET diluent into the RET bath through DP1 and SV24, clean each involved tubing and bath, drain the bath and get ready for the subsequent procedure; Dispense 1.5ml diluent into the HGB bath through DP5 and SV29, measure the blank voltage, and drain the HGB bath after the measurement; Dispense 1ml lyse into the WNB bath through DP3 and SV27, clean each involved tubing and bath, drain the bath and get ready for the subsequent procedure; Dispense 0.5ml lyse into the DIFF bath through DP2 and SV25, clean each involved tubing and bath, drain the bath and get ready for the subsequent procedure; Dispense 2.0ml diluent into the RBC bath through DP6 and SV30, and then wash the bath, drain the RBC bath and get ready for the subsequent procedure; 9.0

V03-N40kPa SV01-50kPa

CV07

T53

T73

T54

DP8 8mL

SV67

WC2-S

WC2-C

OPEN PV05/SV50

DT LH

T42 SV34 T43

Waste Container

SV49

T41

C29 T35 C11 T38

C30 T39

T11

T15

LN

C36

SV48

C21 T19

T12

T16 T17

T13 T14

T36

C16

C12

C17

C13

C18

C14

C19 C20

C15

C1 C6

C2 C7

C3 C8

C4 C9

C5 C10 DIL reagent container

T32

T31 C50

T5

SV47

T33

LD

C35

DIL-V40

T48 T49

SV46 C33

T44

T113 WCT

P7-T4-P8

T28

T25

CV06

T26

10mL

T29

T30

T34

C34

PV06/SV51

FCM-90kPa V66-N40kPa

V66-50kPa

7-25

C22 T20

PUMP_WASTE T353

T361

T18

DIL

C165 T146

C23 T21

P3

LH T360

T359

T346

T352

C25

C157

C144

T351 C147

C143

P5-T3-P6

T243

T245

T244

T246 LH-1

T374 SV45 SV09

C156 LN

LF1

T338

T390 C152 C151 T391 T386 T356 T357 T387

C155

C24

SV72 T45

SV01

C134 T344 CV04

C150 T355

LD

T22

T392

T337

T370

T345 C146 T350

T10

WC1-B

C133 T114

T9 LH reagent container

C65

T389 T385

C135 T339 T343 CV03 C26

C161 WC2

C145 T349

P3-T2-P4 T7 LD reagent container

C66 T135

J11-T144-J12-P11 T373

T331

T336

T347 T348

T112

C56

T84

T383

T8 LN reagent container

SV41

T134

C164

T47

SV69 T52

C137

T91

SV73

C38

T332

C136 T340 T342 CV02 C27

T358

T46 C46 T110

T55

T50

T354 DR

C40

T51

C149

T388

C177

T59 T58

C28

C154

T396

T57

T341

T384

SV68

T56

C138

WC1

P1-T1-P2 T6 DR reagent container

WC2-C

T145

WC1-H

P2

DP4 0.5mL

SV09-50kPa

C58

T371 C162 T124

SV05-50kPa

T95

T118

T111

T393 ICF2

C139

T333

DIL

C37

T133 SV35

SV05 SV42 C47

SV29

C163 T372

DIL-V40

C57 LF2

T224 T211

TC T397 C178

C175 T394

T335

C41 T64 T61 C176 T60T395

T62

SV28 T210

T138 DP5 C70 1.5mL SV11

J6-T122-J7-P10 C54

SV04

SV09-50kPaT300

T315

CV01

T289

FCM

C39

SV12-50kPa OPEN

DIL-CL

T105

ICF1

C125

C174

LF3

T132 T108

WC1-VC

SV40 J2-T92-J3

T409

VCN30KPa 180mL

SV12 SV12-50kPa OPEN

10mL

J61-T85-J62

C51

T97

T410

T90

C124

T330

SV23

HGB

SV32

C153

T334

T63

C68

T121 T130 C64 T131

T119

T100 DP6 2.0mL

SV17-50kPa T364

CV05

WC1-N WC1-H WC1-D WC1-R WC1-VC WC1-S

T115 SV03 T116 T117

T295 SV08-50kPa T299

PV01

WC1-O WC1-RC C118

V66-50kPa

C123

SV07-50kPa T298

C130 T306 C132 T363

C140

T269

T294

C129

SV16-50kPa T314

SV66

C63 T129

T120

T106

T96

C188

ASP_SYRINGE

VC

T94 C187

T127 C62

LF4

C49

C69

SV30 RBC

T74

T75

T140

C95 T168 T177

DIL

T69

VC TS1 C45

LPS T76

T288

C122

PV02

SV75

SV74

T293

WC1-B

SV52

C61

T329

DR

C60

C59

T77 T82

SV39

C42

RH1HGB

DIL_SYRINGE

T89

J8-T126

T125

C121 T292

SV05-50kPa T296 SV06-50kPa T297

T305 SV14-50kPa T312

SV18-50kPa

C83

PS4

T128

SV55

C55

FCM1

T178

SV02 C48

C128

SV13-50kPa T311

C113

RH1 -CL

T65

T68

C127 T303

SV12-50kPa T310

T304

C112

LH

C43

C44

C126 T302

SV11-50kPa T309

V67-50kPa

T147 SV20

T179 C96

SV01-50kPa T308

LH-1

T362

T180

T102

T93

T227

T301

T323

SV18-N40kPa

T148

C67

T198

T328

FCM1

C171

T327

SV17-N40kPa

FCM2

T184 C97

RH1RBC

PWD

SV71

T229

T70

WC1-R

T194

SV16-N40kPa

C98

C52

PN

T149

DIL-CL

SP_SYRINGE

WC1-S

C169

T190

T66

T88

C94 T150

FCM-90kPa

SV38

T380

C93 T151

J27-T185-J28 T186

T67

SV53

T322

C92

T228

SV22

Piercing manifold

T87

C111

T320

T399

SV31 T401 PV07/SV78 SV37 T382 C180 J15-T163-J16 C173

SV54

C110 T321

T326

OPEN SV67-50kPa

PV04/SV77

PV03/SV76

PV02/SV75

SV43

T378

WC1-RC

WC2-S

T381

J13-T152-J14

C91 SV44

C99

T235

C53

T325

SV04-N40kPa

T209 C90

T153 C172

C89

OPEN

T167

T154 C170 T379

C88

WC1-D

T405

J48-T234-J49

WC1-O

T176

J17-T164-J18

J68-T404-J69 C181 T403

T375 SV36 C166

SV03-N40kPa SV07-50kPa

SV06-50kPa

T159 T197 C179 T398

T158 T155 C168 T377

C87

WC1-N

SV33

T156

T402

J23-T175-J24

T376 C167

T193

T157

C86 C182

SV07

SV06 T189

PV01/SV74

C85 J19-T165-J20

J66-T400-J67

J33-T195-J34-P26

T279

T268

T262

SV04-N40kPa

FCM2

J21-T166-J22

T162

C109

SV08-50kPa

C80 T161

T290

C120 T324

SV66-N40kPa

PV03

SV76 T265 OPEN

OPEN

SV13 SV08

T160 T181

FC

J31-T191-J32-P25

C79

RH1 -SH

T172

T173

50KPa

SV21

T169

SV70

C114

SV63

C117

T267

OPEN

T261

C186 T366 Positive pressure waste

GC-90KPa 600mL

T365

SV14-50kPa OPEN SV13-50kPa

GC-50KPa 600mL

C107 T250

90KPa

T171

T208 C71

T213 T221

C72

T318 GC-N40KPa 600mL T319

OPEN

C78

T170

T242

C183

T222

T230

SV14

PV04

SV77

T264

T23

C77

DP3 1.0mL

CV08

C76

T287

DP2 0.5mL

T27

C75

DP1 0.5mL

T266

OPEN

T260 C106 T282

T291

RH 3

T263

C105

C116

C119

T24

T219

PS2

PV07

SV78

OPEN

T278

PV06

SV51 T408

T259

J52-T281 T283

T274

N40KPa

T174 C81

LN

DR

RET

RH 2

RE T

SV18-50kPa SV18-N40kPa

DIFF

RH 2

T272

SV27

T258 OPEN T407

SV65 PS3

C101

T248

T284 SV25

J29-T187-J30-P24

C84 J54-T240-J55 C148 J56-T241-J57

C184 J50-T271

C115

T247

T285 C100

PV05

SV50

T255

T406

SV64

PS1

T286

GC-120KPa 600mL

J25-T182-J26 C82 T183

T280

T317

C160

T225 DI FF

WNB

SV17-50kPa SV17-N40kPa

C159

SV24

SV18

SV16-50kPa SV16-N40kPa

SV17

PS6

C104 T254 C108 T253

120KPa

T270

SV61 J51-T276-J53

C158

WNB

SV16

F D FN DYE bag

T201

C103

T252

SV60

T316

T257

OPEN C102

T251

PS5

C73

DP01 DP11 20uL

F D FD DYE bag

T200

T256

OPEN

C141

SV62

C74 P23-J43

DP10 20uL

FR FR DYE bag

T199

SV26 J46-T217-J47

T218

SV58 P22-J42

DP02 DP9 20uL

OPEN

P17

SV57 P21-J41

SV56

J36-T203-P14

P15

C142

OPEN

P13 J35-T202-P12

LD

P1

J38-T205-P18 J39-T206-P19 J40-T207-P20 J37-T204-P16

Fluidics System

12~31s: as shown in the figure below The sample probe sequentially moves to the RET bath, HGB bath, WNB bath, and DIFF bath for blood sample dispensing. The blood sample dispensed to the RBC bath is the diluted sample from the HGB bath. Clean the exterior and probe wipe after each blood dispensing. Dispense the DR Diluent into the RET bath through DP1 and SV24; at the same time, add the fluorescent dye into the RET bath through DP9 and SV56; open SV06 to bubble, and then the sample in the bath starts reacting; Dispense the diluent into the HGB bath through DP5 and SV29; at the same time, add the LH lyse into the HGB bath through DP4 and SV28; open SV09 to bubble, and then the sample in the bath starts reacting; Dispense the LN lyse into the WNB bath through DP3 and SV27, at the same time, add the fluorescent dye to the DIFF bath through DP11 and SV58; open SV08 to bubble, and then the sample in the bath starts reacting; Dispense the LD lyse into the DIFF bath through DP2 and SV25; at the same time, add the fluorescent dye into the DIFF bath through DP10 and SV57; open SV07 to bubble, and then the sample in the bath starts reacting; Dispense the diluent into the RBC bath through DP6 and SV30; open SV05 to bubble, and then the sample in the bath starts reacting; 9.0

7-26

CV07

C22

SV47

T33

T32

T53

T73

LH

C29 T35 C11 T38

C30 T39

T11

T15

T12

T16 T17

T13 T14

T18 T54

DP8 8mL

SV67

WC2-S

WC2-C

Waste Container

SV49 DT

LN

T43

OPEN

C21 T19

T41

LD

C36

SV48

T42 SV34

DIL-V40

C35

T113 WCT

T36

C16

C12

C17

C13

C18 C19

C14

C20

C15

C1 C6

C2 C7

C3 C8

T5

SV46 C33

T31 C50

PUMP_WASTE T353

T361

T20

T44

P3

P7-T4-P8

T34

C34

T352

C25

C157

C143 T346

P5-T3-P6

T25

T28

T29

T30

CV06

T26

C23 T21

T351 C147

LH T360

C144

C4 C9

C5 C10 DIL reagent container

C165 T146

C156 LN

T345 C146 T350 LF1

T338

T344 CV04

T370

T10

T374 SV45 SV09

T48 T49 SV69

T52

T343 CV03 C26

T359 C24

DR

T50

C134

T339

T390 C152 C151 T391 T386 T356 T357 T387

C155

T22

SV01

C150 T355

LD T358

SV72 T45

SV73

DIL

T373

T47 T55

T51

C133 T114

T392

T337

T91

SV68

C40

C38

C135

WC2

C145 T349

T9 LH reagent container

FCM-90kPa

10mL

C154

C136 T340 T342 CV02 C27

T389 T385

DR T46 C46 T110

C177

T59 T58

C28

C149 T354

WC1-B

V66-50kPa

C164

SV12-50kPa OPEN

WC1-B

CV05

DIL

C37 DP4 0.5mL

T341

T388

C41 T64 T61 C176 T60T395

T56

T336

C137

T331

C161

T348 T112

C56

T84

T383 T347

PV05/SV50

T393 ICF2

C138

T332

WC1

P3-T2-P4 T7 LD reagent container

C66 T135

C65

T394

C139

T333

T384

T396

T57

TC T397 C178

C175

T8 LN reagent container

T243

T245

T244

T246 FCM1

FCM2 LH

LH-1

SV29

WC1-H

SV41

WC1-VC

C47 WC2-C

T134 SV05-50kPa

P2

WC1-RC

T97

LF2

T371 C162 T124

SV09-50kPaT300

C153

CV01

SV66

T62

T224 T211

SV28 T210

SV09-50kPa

SV42 T118

T111

SV04

C174

LF3

T138 DP5 C70 1.5mL SV11

T133 SV35

SV05

DIL-V40

C125

T330

T289

FCM

C39

C163 T372

C54

C132 T363

T335

SV23

T132

C57

FCM-90kPa

WC1-R J8-T126

T105

DIL-CL

VCN30KPa 180mL

ICF1

C124

T295 SV08-50kPa T299

T315

C140

WC1-N WC1-H WC1-D WC1-R WC1-VC WC1-S

T115 SV03

T294

C130 T306

T334

T63

C69

SV32

LF4

C49

HGB

T106 C51

C95 T168 T177

C68

T121 T130 C64 T131

SV12 SV12-50kPa OPEN

10mL

J61-T85-J62

T140

T127 C62

T119

T100 DP6 2.0mL

SV16-50kPa T314

WC1-O WC1-RC

T116 T117

C123

PV01

SV74

C118

V66-50kPa

C122

SV07-50kPa T298

T305 SV14-50kPa T312

T269

T293

C129

SV13-50kPa T311

C113

T288

T292 SV05-50kPa T296 SV06-50kPa T297

T304

C112

T329

C63 T129

T120

SV30

C128

T323

C83

T69

RH1HGB

C61

C127 T303

SV12-50kPa T310

SV18-50kPa

DIL

PS4

VC

T90

C58

FCM1

T178

C42

OPEN

T125

C126 T302

SV11-50kPa T309

T262

V67-50kPa

PV02

SV75

OPEN

C121

T147 SV20

T179

T128

C60

SV01-50kPa T308

SV17-50kPa T364

SV02 C48

RBC

T95

T328

RH1 -CL

T362

TS1

T96

T410

ASP_SYRINGE

VC

C188

T327

SV17-N40kPa

T301

LH-1

T65

T68

C59

C45

T74

T409

T227

C96

SV52

SV40 J2-T92-J3

SV16-N40kPa

SV18-N40kPa

T148

C67

C43

T77

T94 C187

SV71

T229

T70

T198

C44

LPS T76

T93

T149

C98

T82

PWD

C94 T150

DIL_SYRINGE

SP_SYRINGE

T186

T89

T75

C93 T151

DIL-CL

C171

SV55

SV39

C92

J27-T185-J28

RH1RBC

C55

J13-T152-J14 T228

T180

T102

T88

C111

T209

T381 SV38

T380

T194

T184 C97

Piercing manifold

PN

C110 T321

T326

V66-N40kPa

PV04/SV77

PV03/SV76

PV02/SV75

C169

T190

C52

SV53

SV06-50kPa

SV22

T66

T87

T325

SV04-N40kPa

T320

T399

T67

SV54

SV03-N40kPa SV07-50kPa

T322

C90

T153 C172

C89

WC1-D

T405

WC1-S

SV43

T378

WC1-N

WC2-S

T154 C170 T379

C88

C91 SV44

C99

T235

C53

SV07

T159 T197 C179 T398

T158 T155 C168 T377

C87

SV31 T401 PV07/SV78 SV37 T382 C180 J15-T163-J16 C173

WC1-O

T176

T375 SV36 C166

T167

T402

J23-T175-J24

C167

T156 J17-T164-J18

J68-T404-J69 C181 T403 J48-T234-J49

T162

T279

T268

OPEN

SV04-N40kPa

FCM2

J66-T400-J67 SV33

C109

SV06 T193

T157

C86 J19-T165-J20 C182

T324

SV66-N40kPa SV08-50kPa

C80 T161

T189

PV01/SV74

C85

T173

T376

T160 T181

FC

C183

SV08

OPEN SV67-50kPa

RH1 -SH

T290

C120

SV13

C79

T169

T172

J21-T166-J22

50KPa

SV21

T242 SV70

90KPa

T174 C81

N40KPa

C72

T171

C117 OPEN SV13-50kPa

T221

C186 T366 Positive pressure waste

GC-90KPa 600mL

T365 C114

PV03

SV76 T265

C107 T250 SV63

C78

T170

C84 J54-T240-J55 C148 J56-T241-J57

T213

T318 GC-N40KPa 600mL T319

OPEN SV14-50kPa

V03-N40kPa

T222

T230

SV14 T208 C71

PV06/SV51

C77

DP3 1.0mL

P1-T1-P2 T6 DR reagent container

C76

DP2 0.5mL

T267

OPEN

T261

SV01-50kPa

DP1 0.5mL

PV04

SV77

T264

T282 GC-50KPa T287 600mL

T266

OPEN

T260 C106

T291

RH 3

T263

C105

C116

C119

PV07

SV78

OPEN

T283

PS2

T278

T23

RH 2

C75

T272

T274

CV08

RET

RE T

SV18-50kPa SV18-N40kPa

T219

T248

GC-120KPa 600mL

T225

DIFF

RH 2

T286

SV27

PV06

SV51 T408

T259

J52-T281

T284 SV25

T258 OPEN T407

SV65 PS3

C101

T317

C160

J25-T182-J26 C82 T183

C184 J50-T271

C115

T247

PV05

SV50

T255

T406

T27

C159

SV24

WNB

SV17-50kPa SV17-N40kPa

SV16-50kPa SV16-N40kPa

PS5

T24

C158

SV18

T280 SV64

PS1 J51-T276-J53

DI FF

SV17

F D FN DYE bag

T201

C104 T254 C108 T253

120KPa

T270

SV61

T285 C100

T257

OPEN C103

T252

SV60

T316

WNB

SV16

DP01 DP11 20uL

F D FD DYE bag

T200

T256 C102

T251

C141 PS6

C73 P23-J43

DP10 20uL

FR FR DYE bag

T199

P22-J42

P21-J41

DP02 DP9 20uL

C142

OPEN

SV62

C74

SV58

SV57

OPEN

T218 SV56

LN

DR

SV26 J46-T217-J47

OPEN

LD

P1

Fluidics System

31~42.6s: as shown in the figure below Open SV39 and SV53, and then the 10mL syringe pushes the diluent out of the sample probe cleaning channel. In the meanwhile, open SV40 to clean the exterior of the probe. When the cleaning is completed, the sample probe returns to its “ready for work” status; Keep the HGB bath sample still for a moment, and then start measurement; drain the HGB bath after the measurement; dispense diluent to wash the bath twice (1.5mL diluent each time); Open SV32 to form a sample flow, and start the RBC channel measurement; With the corporate efforts of SV36, PV01 and PV02, the sample in the WNB bath gets to the inlet of the three-way connector of the flow cell; open SV70 to form the sheath flow; With the help of SV33, the SP_SYRINGE sample syringe pushes the WNB sample located in the sample preparation tubing into the optical analysis area of the flow cell for the measurement; Drain the WNB bath; open SV71 and PV02 to dispense about 1.4ml diluent into the WNB bath. The WNB bath then gets ready for analysis; Open SV71, SV36 and PV01 to clean the optical analysis sample preparation channel; Other auxiliary actions: Prime the FCM cistern with diluent from the diluent container through the DIL_SYRINGE syringe; Prime the DIL cistern through the DIL vacuum; Drain WC1 to the waste container The WNB channel tests completes. 9.0

正压废液

SV41

C66 T135

WC1-B

SV45 SV09

C165

7-27

V03-N40kPa

SV47

T33

CV07

T28

T32

C36

T73

C29 T35 C11 T38

C30 T39

T11

T15

T12

T16 T17

T13 T14

T18 T54

DP8 8mL

SV67

WC2-S

OPEN PV05/SV50

DT LH

T43

Waste Container

SV49

T41 T42 SV34 LN

C35

T53

SV48

C21 T19

T36

C16

C12

C17

C13

C18

C14

C19 C20

C15

C1 C6

C2 C7

C3 C8

T5

SV46 C33

T44

T31 C50

P7-T4-P8

T26

T25

CV06

T29

T30

T34

C34

T113 WCT

P5-T3-P6

FCM-90kPa

T48 T49 SV69

T52

T20

PUMP_WASTE T353

C4 C9

C5 C10 T10

C65

C164

SV72 T45

T352

T361 C22

T21

C143 T346

DIL reagent container

C47 WC2-C

T134

WC1-VC

P2

T371 C162 T124 WC1-RC

T97

C58

T96

T95

T133 SV35

SV05 SV42 T118

T50

C23

C24 T22

C144

P3

LH T360

T359

T345 C146 T350

C25

C157

LN

LD

T370

T351 C147

C152 C151 T391 T357 T387 T356 C156

WC2

LF1

T338

T344 CV04

C161

C145 T349

P3-T2-P4 T7 LD reagent container

C54

J11-T144-J12-P11

T47 T55

T51 C38

C155

T386

SV01

C56

T84

T383 T347

T8 LN reagent container

C163 T372

DIL-V40 T111

SV68

C40

DIL

J6-T122-J7-P10

WC1-H

T108

SV09-50kPa

ICF1

DIL_SYRINGE

T132

C57

LF2

DP4 0.5mL

C133 T114

T392 C134

WC1

T348 T112

T337

T339 T343 CV03 C26 T390

C150 T355

C137

T331

C135

T91

SV73 C37

T138 DP5 C70 1.5mL SV11

T340 T342 CV02 C27

T358

C177

T59 T58

T56

T336

T389 T385

DR T46 C46 T110

T396

T57

C28

C149 T354 C154

C41 T64 T61 C176 T60T395

T62

T224 T211

SV28 T210

SV29 VCN30KPa 180mL

SV12 SV12-50kPa OPEN

C51

SV40 J2-T92-J3

T409

SV32

CV01 T388 T384

LF3 C69

C138

T332 C136

T341

CV05

SV23

HGB

C139

T333

DIL

FCM T63

T130

T106 T90

T315

C174

SV66

C63 T129

T100 DP6 2.0mL

T394

T330

T289

LF4

TC T397 C178

C175

T393 ICF2

T335

10mL

LH-1

C95

C49

C68

SV12-50kPa OPEN

ASP_SYRINGE

J61-T85-J62

PWD

DIL-CL

T74

SV04

C153

T334

T168 T177

C39

SV39

C125

LD

T127 C62

C64 RBC

SV09-50kPaT300

DIL-V40

T140

VC

SV30

C132 T363

WC1-B

C83 DIL

T69

RH1HGB

TS1 C45

C124

T295 SV08-50kPa T299

SV16-50kPa T314

C140

WC1-H WC1-D WC1-R WC1-VC WC1-S

T115 SV03 T116 T117

C123

SV07-50kPa T298

C130 T306

SV18-50kPa

LH

C42 PS4

C61

C129

SV14-50kPa T312

DR

SV52

LPS T76

10mL

FCM1

T178

WC1-N

T294

T147 SV20

T179

WC1-O WC1-RC C118

V66-50kPa

C122

PV01

SV74

T293

T305

T329

T288

T292 SV05-50kPa T296 SV06-50kPa T297

C128

SV13-50kPa T311

C113

V66-50kPa

WC1-R

T125 C60

T77 T82

VC

T362

T128

C59

C112 T323

V67-50kPa

C121

T304

SV17-50kPa T364

SV02 C48

C127 T303

SV12-50kPa T310

RH1 -CL

T65

T68

SV11-50kPa T309

LH-1

C67

C43

C44

T89

T410

T227

C96

SV55

C187

T328

SV18-N40kPa

T229

T70

T198

T327

SV17-N40kPa

C98

T102

T93

SV71

T228

J8-T126

T186

穿刺汇流板

C188

C94

J27-T185-J28

C52

T94

C93

FCM2

C171

SV16-N40kPa T209

T180

RH1RBC

C55

C111

DIL-CL

T184 C97

T66

T88

C110 T321

C126 T302

V66-N40kPa

SV38

T380

T194

PV07/SV78

T67

PN

SV06-50kPa

SV22

SP_SYRINGE

WC1-S

SV43 C169

SV31

SV53

T326

T301

SV01-50kPa T308

C92

T399

T235

T87

T325

SV04-N40kPa

OPEN SV67-50kPa

SV44

C99

SV37 T382 C180 C173

SV54

SV03-N40kPa SV07-50kPa

T279

T322

C90

C172

T381

C91

C181 J48-T234-J49

SV07

FCM1

C89

SV05-50kPa

WC1-O

T159 T197 C179 T398

C170 T379

OPEN

T167

C88

C168

WC1-N

T176 WC2-S

C167

T193 T158 C87

WC1-D

T375 SV36 C166

J33-T195-J34-P26

T320

FCM-90kPa

PV01/SV74 C86

C182

J66-T400-J67

T162

C109

T324

SV06

C85 C183 J21-T166-J22 SV33

T161

SV66-N40kPa SV08-50kPa

SV04-N40kPa

FCM2

FC

PV04/SV77

T181 T169

SV70

PV03/SV76

T242

T290

C120

SV13 SV08

C80 PV02/SV75

C81

J31-T191-J32-P25

C79

T269

WC2-C

50KPa

90KPa

SV21 RH1 -SH

PV02

SV75

T262 OPEN

C78 C84 J54-T240-J55 C148

PV03

T268

OPEN

T9 LH reagent container

C114

SV63

C117

C186 T366

GC-90KPa 600mL

T365

SV14-50kPa OPEN SV13-50kPa

T265

C107 T250

N40KPa

J29-T187-J30-P24

T208 C71

T213 T221

C72

T318 GC-N40KPa 600mL T319

OPEN

PV06/SV51

T222

T230

SV14

SV76

P1-T1-P2 T6 DR reagent container

T243

T245

T244

T246

DP3 1.0mL

T267

OPEN

T261

SV01-50kPa

C77

DP2 0.5mL

PV04

SV77

T264

T282 GC-50KPa T287 600mL

T266

OPEN

T260 C106

T23

DP1 0.5mL

T263

C105

C116

C119

CV08

C76

T283

PS2

T278

T291

RH 3

J25-T182-J26 C82 T183

C53

LN

DR

RET

RH 2

C75

T272

T274

PV07

SV78

OPEN

T27

SV18-50kPa SV18-N40kPa

SV17-50kPa SV17-N40kPa

T219

T248

GC-120KPa 600mL

T225

DIFF

RH 2

T286

SV27

PV06

SV51 T408

T259

J52-T281

T284 SV25

T258 OPEN T407

SV65 PS3

C101

T24

WNB

C184 J50-T271

C115

T247

T285 C100

PV05

SV50

T255

T406

SV64

PS1

T317

C160 SV24

SV18

SV16-50kPa SV16-N40kPa

C159

RE T

SV17

C104 T254 C108 T253

120KPa T280

J51-T276-J53

C158

WNB

SV16

F D FN染料袋

T201

C103

T252

T270

SV61

PS5 T316

T257

OPEN C102

T251 SV60

PS6

C73

DP01 DP11 20uL

F D FD染料袋

T200

T256

OPEN

C141

SV62

C74

DI FF

DP10 20uL

FR FR染料袋

T199

P22-J42

P21-J41

DP02 DP9 20uL

SV26 J46-T217-J47

T218

SV58

SV57

OPEN

P17

P23-J43

SV56

J36-T203-P14

P15

J40-T207-P20 J37-T204-P16

C142

OPEN

P13 J35-T202-P12

LD

P1

J38-T205-P18 J39-T206-P19

Fluidics System

42.8~59.7s: as shown in the figure below The RBC channel measurement completes; drain the RBC bath, and wash the RBC bath twice (with 2.0mL diluent each time); With the corporate efforts of SV36, PV01 and PV03, the sample in the DIFF bath gets to the inlet of the three-way connector of the flow cell; open SV70 to form sheath flow; With the help of SV33, the SP_SYRINGE sample syringe pushes the DIFF sample located in the sample preparation tubing into the optical analysis area of the flow cell for the measurement; Drain the DIFF bath; open SV71 and PV03 to dispense about 1.5ml diluent into the DIFF bath; the DIFF bath gets ready for analysis; Open SV71, SV36 and PV01 to clean the optical analysis sample preparation channel; Other auxiliary actions: Prime the FCM cistern with diluent from the diluent container through the DIL_SYRINGE syringe; Prime the DIL cistern through the DIL vacuum; Drain WC1 to the waste container; DIFF channel measurement completes. 9.0

SV41

T124

C66 T135

WC1-B

C165

7-28

CV07

SV47

T33

T32

C29 T35 C11 T38

C30 T39

T11

T15

T12

T16 T17

T13 T14

T18 T54

DP8 8mL

SV67

WC2-S

WC2-C

OPEN

DT LH

T43

Waste Container

SV49

T41 T42 SV34 LN

C36

T73

PV05/SV50

FCM-90kPa

C35

T53

SV48

C21 T19

T36

C16

C12

C17

C13

C18 C19

C14

C20

C15

C1 C6

C2 C7

C3 C8

T5

SV46 C33

T44

T31 C50

P7-T4-P8

T34

C34

T113 WCT

P5-T3-P6

T25

T28

T29

T30

CV06

T26

V66-50kPa

SV45 SV09

T20

PUMP_WASTE T353

C4 C9

C5 C10 T10

C65

SV72 T45

P3

T361 C22

T21

C143 T346

T352

C25

C157

C144

T351 C147

LH T360

C23

C24

T345 C146 T350

DIL reagent container

C47 WC2-C

WC1-VC

P2

WC1-RC

C58

T96

T95

T97

LF2

T134

T118

T111

C164

C156 LN

T359

T370

LF1

T338

T344 CV04

WC2

T9 LH reagent container

T133 SV35

SV05

DIL-V40

J11-T144-J12-P11

T48 T49 SV69

T52

T339 T343 CV03 C26

C161

C145 T349

P3-T2-P4 T7 LD reagent container

C163 T372

C57

T50

T51 C38

DIL

ICF1

DIL_SYRINGE

T132

WC1-H

SV40 J2-T92-J3

T409

DP4 0.5mL

T47 T55

SV01

C134

T91

SV68

C40 SV73

T392

T337

C135

T390 C152 C151 T391 T386 T356 T357 T387

C155

T22

C137

T331

C150 T355

LD T358

C177

T59 T58

T56

T340 T342 CV02 C27

T389 T385

DR T46 C46 T110

T396

T57

C37 T138 DP5 C70 1.5mL SV11

SV09-50kPa

C51

SV29 VCN30KPa 180mL

SV12 SV12-50kPa OPEN

T90

SV32

T100 DP6 2.0mL

SV12-50kPa OPEN

ASP_SYRINGE

J61-T85-J62

PWD

DIL-CL

T74

10mL

T62

T224 T211

SV28 T210

T354 C154

DIL

SV23

C69

T130

C28

C149

T388

LF3

C68

CV05

T384

C41 T64 T61 C176 T60T395

C136

T341 CV01

SV66

FCM

T336

T335

T289

T63

HGB

C64 RBC

C174 C138

T332

C56

T84

T383 T347 T348

T112

C133 T114

T330 C139

WC1

T8 LN reagent container

T243

T245

T244

T246 LH-1

LF4

C49

TC T397 C178

C175 T394

LD

T127 C62

C95 T168 T177

C39 SV30

SV04

T393 ICF2

T334

C63 T129

TS1 C45

LPS T76

C125

C153

T333

DIL-V40

T140

VC

T77 T82

SV09-50kPaT300

WC1-B

SV52

C61

C132 T363

T315

C140

DR

T125 C60

C59

T69

RH1HGB T128

C48

C83 DIL

PS4 SV02

T89

10mL

C42

T65

T68

SV55

VC

FCM1

T178

LH

C43

T102

T410

SV18-50kPa

C124

T295 SV08-50kPa T299

T147 SV20

WC1-N WC1-H WC1-D WC1-R WC1-VC WC1-S

T115 SV03

T294

C130 T306

SV17-50kPa T364

C98

C44

SV16-50kPa T314

RH1 -CL

T179 C96

T329

WC1-O WC1-RC

T116 T117

C123

PV01

SV74

C118

V66-50kPa

C122

SV07-50kPa T298

T305 SV14-50kPa T312

T269

T293

C129

SV13-50kPa T311

C113

T288

T292 SV05-50kPa T296

T304

C112 T323

LH-1

T362

J8-T126

T186

Piercing manifold

C188

T227

C67

T198

T328

FCM2

C171

T327

SV17-N40kPa SV18-N40kPa

J27-T185-J28

C52

T93 T94 C187

SV71

T229

T70

WC1-R

T194

SV16-N40kPa

FCM1

SV38

C94

V67-50kPa

PV02

SV75

T262 OPEN

C121

SV06-50kPa T297

C128

SV12-50kPa T310

FCM-90kPa

T380

C93

T228

T180

RH1RBC

SV39

C111

DIL-CL

C169

T184 C97

T66

C55

C110 T321

T209

SV22

SP_SYRINGE

WC1-S

SV43

PV07/SV78

T67

T88

SV06-50kPa

T399 SV31

SV53

T326

V66-N40kPa

PV04/SV77

PV03/SV76

SV44

C99

T235

T87

T325

SV04-N40kPa

T301

C126 SV01-50kPa T308 T302 SV11-50kPa T309 C127 T303

C92

C91

C181

SV37 T382 C180 C173

SV54

T320 SV03-N40kPa

SV07-50kPa

T279

T322

C90

T381

J48-T234-J49

SV07

C172

SV05-50kPa

WC1-O

C89

C170

OPEN

WC2-S

C88

C168

WC1-N

T167

C87

WC1-D

T375 SV36 C166

T176

J33-T195-J34-P26

T159 T197 C179 T398

T158

C86 C182

J66-T400-J67

T162

C109

T324

SV06 PV01/SV74

C85 C183 J21-T166-J22

C167

T161

SV66-N40kPa SV08-50kPa

OPEN

SV04-N40kPa

FCM2

FC

PV02/SV75

T181 T169

SV70

T290

C120

SV13 SV08

C80

T242

SV33

J31-T191-J32-P25

C79

OPEN SV67-50kPa

SV21 RH1 -SH

PV03

T268

V03-N40kPa

50KPa

90KPa

N40KPa

C186 T366 Positive pressure waste

GC-90KPa 600mL

T365 C114

SV63

C117 OPEN SV13-50kPa

T265

C107 T250

SV14-50kPa

T221

C72

J29-T187-J30-P24

T208 C71

T213

T318 GC-N40KPa 600mL T319

OPEN

PV06/SV51

T222

T230

SV14

PV04

T267 SV76

P1-T1-P2 T6 DR reagent container

C77

DP3 1.0mL

SV01-50kPa

C76

DP2 0.5mL

T266

OPEN

T261

T23

C75

DP1 0.5mL

GC-50KPa T287 600mL

SV77

T264

T282

T291

RH 3

OPEN

T260 C106

CV08

RET

RH 2

T263

C105

C116

C119

PV07

SV78

OPEN

T283

PS2

T278

C78 C84 J54-T240-J55 C148

C81

PN

LN

DR

T219

T272

T274

T27

SV18-50kPa SV18-N40kPa

SV17-50kPa SV17-N40kPa

T225

DIFF

RH 2

T248

GC-120KPa 600mL

PV06

SV51 T408

T259

J52-T281

T24

WNB

T286

SV27

T258 OPEN T407

SV65 PS3

C101

T284 SV25

PV05

SV50

T255

T406 C184

J50-T271

C115

T247

T317

C160

J25-T182-J26 C82 T183

C53

PS5

SV24

SV18

SV16-50kPa SV16-N40kPa

C159

RE T

SV17

T280 SV64

PS1 J51-T276-J53

C158

WNB

SV16

C104 T254 C108 T253

120KPa

T270

SV61

T285 C100

T257

OPEN C103

T252

SV60

T316

F D FN DYE bag

T201

T256 C102

T251

C141 PS6

C73

DP01 DP11 20uL

F D FD DYE bag

T200

C142

OPEN

SV62

C74

DI FF

DP10 20uL

FR FR DYE bag

T199

P22-J42

P21-J41

DP02 DP9 20uL

SV26 J46-T217-J47

T218

SV58

SV57

OPEN

P17

P23-J43

SV56

J36-T203-P14

P15

J40-T207-P20 J37-T204-P16

OPEN

P13 J35-T202-P12

LD

P1

J38-T205-P18 J39-T206-P19

Fluidics System

60~75.7s: as shown in the figure below With the corporate efforts of SV36, PV07 and PV04, the sample in the RET bath gets to the inlet of the three-way connector of the flow cell; open SV70 to form sheath flow; With the help of SV33, the SP_SYRINGE sample syringe pushes the RET sample located in the sample preparation tubing into the optical analysis area of the flow cell for the measurement; Drain the RET bath; open SV71 and PV04 to dispense about 2.6ml diluent into the RET bath. The RET bath gets ready for analysis; Open SV71, SV36 and PV07 to clean the optical analysis sample preparation channel; Other auxiliary actions: Prime the FCM cistern with diluent from the diluent container through the DIL_SYRINGE syringe; Prime the DIL cistern through the DIL vacuum; Drain WC1 to the waste container; The RET channel measurement completes. 9.0

T124

C65

WC1-B

V03-N40kPa

CV07

T34

SV46 C33

SV47

T33

T32

T44 C34

SV48 T73

T54

DP8 8mL

SV67

C165

WC2-S

OPEN

Waste Container

SV49 DT

LH

T43

PV05/SV50

C21 T19

T41

C29 T35 C11 T38

C30 T39

T11

T15

LN

C36

T31 C50

T42 SV34

T12

T16

LD

C35

T53

T113 WCT

T17

T13 T14

T36

C16

C12

C17

C13

C18 C19

C14

C20

C15

C1 C6

C2 C7

C3 C8

T5

T28

T25

T30

CV06

T26

T29

T20

PUMP_WASTE T353

P7-T4-P8

SV72 T45

P3

T361 C22

T21

C143 T346

T352

C25

C157

C144

P5-T3-P6

V66-N40kPa

V66-50kPa

SV45 SV09

C23

C24

T345 C146 T350

LH T360

T370

T351 C147

T18

DIL

C164

T48 T49 SV69

T52

C156 LN

T359

WC2

C145 T349

LF1

T338

T344 CV04

T390 C152 C151 T391 T386 T356 T357 T387

C155

T22

SV01

C150 T355

LD T358

DIL-V40

LH-1

LH

T50

T339 T343 CV03 C26

C161

C4 C9

C5 C10 DIL reagent container

C66 T135 WC1-VC

SV41

SV05-50kPa

C47 WC2-C

P2

WC1-RC

C58

T96

T95

T97

LF2

T134

T118

T111

10mL

FCM1

DIL-CL

FCM2

T133 SV35

SV05

DIL-V40

C57

J11-T144-J12-P11

DIL_SYRINGE

C163 T372

T47 T55

T51

C133 T114

T392 C134

C56

T84

T383 T347 T348

T112

T337

C135

T91

SV68

C40

C38

T340 T342 CV02 C27

C137

T331

WC1

T10

T409

DP4 0.5mL

T132 ICF1

C154

SV73 C37

T138 DP5 C70 1.5mL SV11

T336

T389 T385

DR

C177

T59 T58

T56

C28

C149 T354

T46 C46 T110

WC1-H

SV40 J2-T92-J3

SV29 VCN30KPa 180mL

SV09-50kPa

C51

SV32

CV01 T388

DIL

T396

T57

C138

T332 C136

T341

T384

C41 T64 T61 C176 T60T395

T62

T224 T211

SV28 T210

C139

T333

CV05

SV23

C69

SV12 SV12-50kPa OPEN

T90

T393 ICF2

C174

SV66

FCM

TC T397 C178

C175

T330

LF3

T130

T100 DP6 2.0mL

SV04

T394

T335

T289

T63

C68

SV12-50kPa OPEN

ASP_SYRINGE

J61-T85-J62

PWD

DIL-CL

T74

SV39

10mL

LF4

C49

HGB

C64

C125

C153

T334

C63 T129

SV30 RBC

C55

VC

T127 C62

C95 T168 T177

C39 C45

LPS T76

T410

T140

VC TS1

T82

SV09-50kPaT300

WC1-B

SV52 T77

C83 DIL

T69

RH1HGB

C61

C132 T363

T315

C140

DR

T125 C60

C59

J8-T126

T89

C188

C42 PS4

T128

C48

SV55

T93 T94 C187

FCM1

T178

SV02

T102

C124

T295 SV08-50kPa T299

T147

T65

T68

RH1RBC

Piercing manifold C52

T88

SV18-50kPa

WC1-H WC1-D WC1-R WC1-VC WC1-S

T115 SV03 T116 T117

C123

T294

C130 T306

SV17-50kPa T364

SV20

C43

T66

SV16-50kPa T314

RH1 -CL

T179 C96

T329

WC1-N

C118

V66-50kPa

C122

SV07-50kPa T298

T305 SV14-50kPa T312

WC1-O WC1-RC

T293

C129

SV13-50kPa T311

C113

T288

T292 SV05-50kPa T296 SV06-50kPa T297

T304

C112

LH-1

T362

T180

C44

C128

T323

C98

T67

C127 T303

SV12-50kPa T310

PV01

SV74

T9 LH reagent container

T227

J27-T185-J28 T186

T328

SV18-N40kPa

C67

T198 WC1-R

C171

FCM-90kPa

PV04/SV77

PV03/SV76

T184 C97

T327

SV17-N40kPa

C126 T302

SV11-50kPa T309

V67-50kPa

C121

P3-T2-P4 T7 LD reagent container

SV71

T229

SV22

SP_SYRINGE

WC1-S

T194

PV07/SV78

SV16-N40kPa

SV01-50kPa T308

T269

T8 LN reagent container

T243

T245

T244

T246

C94

FCM-90kPa

T402

SV38

OPEN

WC1-O

T380

WC1-D

WC2-S

SV43 C169

SV31

T235

SV53

C111

T301

C92

C91 SV44

C99

SV37 T382 C180 C173

T87

C110 T321

T326

T209 C93

C89

C170

T399

SV54

T325

SV04-N40kPa

T320

SV06-50kPa

C88

C168

T228

C181

SV03-N40kPa SV07-50kPa

T279

T322

C90 C87

WC1-N

T176

SV07

T158

C86 C182

T375 SV36 C166

T167

J33-T195-J34-P26

SV06 PV01/SV74

C85 C183 J21-T166-J22

C167

T161

C109

T262

SV04-N40kPa

FCM2

FC

PV02/SV75

T181 T169

SV70

T290

C120 T324

SV66-N40kPa SV08-50kPa

PV02

SV75

OPEN

SV13 SV08

C80

T242

SV33

J31-T191-J32-P25

C79

OPEN SV67-50kPa

SV21 RH1 -SH

T268

OPEN

WC2-C

50KPa

90KPa

C72

J29-T187-J30-P24

C117 OPEN SV13-50kPa

T221

C186 T366 Positive pressure waste

GC-90KPa 600mL

T365 C114

PV03

SV76 T265

C107 T250 SV63

N40KPa

T213

T318 GC-N40KPa 600mL T319

OPEN SV14-50kPa

PV06/SV51

T222

T230

SV14 T208 C71

PV04

T267

P1-T1-P2 T6 DR reagent container

C77

DP3 1.0mL

T266 SV77

T264 OPEN

T261

SV01-50kPa

C76

DP2 0.5mL

GC-50KPa T287 600mL

T23

C75

DP1 0.5mL

T263 OPEN

T282

T291

RH 3

T260 C106

CV08

RET

RH 2

C105

C116

C119

PV07

SV78

OPEN

T283

PS2

T278

C78 C84 J54-T240-J55 C148

C81

PN

LN

DR

T219

T272

T274

T27

SV18-50kPa SV18-N40kPa

SV17-50kPa SV17-N40kPa

T225

DIFF

RH 2

T248

GC-120KPa 600mL

PV06

SV51 T408

T259

J52-T281

T24

WNB

T286

SV27

T258 OPEN T407

SV65 PS3

C101

T284 SV25

PV05

SV50

T255

T406 C184

J50-T271

C115

T247

T317

C160

J25-T182-J26 C82 T183

C53

PS5

SV24

SV18

SV16-50kPa SV16-N40kPa

C159

RE T

SV17

T280 SV64

PS1 J51-T276-J53

C158

WNB

SV16

C104 T254 C108 T253

120KPa

T270

SV61

T285 C100

T257

OPEN C103

T252

SV60

T316

F D FN DYE bag

T201

T256 C102

T251

C141 PS6

C73

DP01 DP11 20uL

F D FD DYE bag

T200

C142

OPEN

SV62

C74

DI FF

DP10 20uL

FR FR DYE bag

T199

P22-J42

P21-J41

DP02 DP9 20uL

SV26 J46-T217-J47

T218

SV58

SV57

OPEN

P17

P23-J43

SV56

J36-T203-P14

P15

J40-T207-P20 J37-T204-P16

OPEN

P13 J35-T202-P12

LD

P1

J38-T205-P18 J39-T206-P19

7.11.2 CT-micro-WB Analysis Sequences The process of the CT-micro-WB analysis is almost the same as that of the CT-WB analysis; The differences between the two modes are: 1. the piercing action is not required for the microWB mode, and the building and balancing vacuum actions (which are related with tube piercing) are also canceled; 2. the dilution ratio and analysis time of the micro-WB mode are different from the WB mode.

7-29

Fluidics System

7.11.3 CT-PD Analysis Sequences The process of the CT-PD analysis is almost the same as that of the CT-WB analysis; The differences between the two modes are: 1. The piercing action is not required for the PD mode, he piercing action is not required for the micro-WB mode, and the building and balancing vacuum actions (which are related with tube piercing) are also canceled; 2. The dilution ratio and analysis time of the PD mode are different from the WB mode; 3. The sample in the PD mode is manually diluted in a certain proportion, and the sample in the whole blood mode is the venous blood without the dilution.

7.11.4 Autoloading Whole-Blood Analysis Sequences You can achieve automatic batch analyses of blood samples by using the autoloading presentation mode, which includes transporting and feeding of tube racks, tube grabbing, automatic aspiration of sample, etc.; Except the differences in the bulk tube delivery, tube loading, and auto mixing, the AL-WB measurement procedure is identical to the CT-WB measurement procedure.

7-30

Fluidics System

7.12 Fluidics Diagram The following are the fluidics diagram and assemblies involved: 1

2

3

4

5

6

7

8

MRSZ/R05N01.291.02（4.0）

V03-N40kPa

CV08

CV07

LN

T20

T73

T54

DP8 8mL

LH

C29 T35 C11 T38

C30 T39

T11

T15

T12

T16

LD

WC2-S

PV05/SV50

PV06/SV51

DT

LN

T43

Waste Container

SV49

T41

WC1-B

C36

DIL-V40

C35

T53

SV48

T17

T13 T14

SV67

C16

C12

C17

C13

C18 C19

C14

C20

C15

T36

C1 C6

C165 T146

C2 C7

C3 C8

T5

T32

C21

T19

C4 C9

C5 C10 T10

SV47

T33

T42 SV34

DR

T48 T49 SV69

SV46 C33

T44

T113

WCT

DIL reagent container

T34

C34

T31 C50

PUMP_WASTE T353

P7-T4-P8

SV72 T45

P3

T361 C22

T21

C143 T346

T352

P5-T3-P6

C23

C24

C144

T351 C147

LH T360

T359

T345 C146 T350

LF1

C25

C157

T370

T9 LH reagent container

T28

T25

C156

WC2

C145 T349

T338

T390 C152 C151 T391 T386 T356 T357 T387

LD

T22

C134 T344 CV04

C150 T355 C155

T358

SV01

T29

T30

CV06

T26

C135 T339 T343 CV03 C26

WC2-C

OPEN

SV01-50kPa

C133 T114

T392

T337

T18

T374 SV45 SV09

C136 T340 T342 CV02 C27

T84 C161

T348 T112

T23

FCM-90kPa

10mL

LH

LH-1

V66-N40kPa

V66-50kPa FCM1

FCM2

WC1-B

T336

C56

T383 T347

P3-T2-P4 T7 LD reagent container

C65

T47 T55

T52

C137

T331

T91

SV68

T50

C138

T332

T389 T385

DR

T46 C46 T110

C40

T51

T354 C154

SV73

C38

C28

C149

T388

C177

T59 T58

T56

C37 DP4 0.5mL T145

C164 J11-T144-J12-P11 T373

C66 T135

CV05

T384

T396

T57

T143

T138 DP5 C70 1.5mL SV11

WC1-VC

P2

T134 SV05-50kPa

SV41

WC1-RC

T97

T96

C47 WC2-C

T371 C162 T124

T62

T224 T211

SV28 T210

T137 SV29

T133 SV35

SV05 SV42 T118

T111

C69 T212

T341 CV01

SV23

C39

C163 T372

DIL-V40

C57 LF2

T393 ICF2

C139

T333

C31

WC1

T8 LN reagent container

J6-T122-J7-P10 T123 C54 T83

T394

C174

LF3 HGB

TC T397 C178

C175

T330

C41 T64 T61 C176 T60T395

T63

T132 T108

SV04

SV09-50kPaT300

T335

OPEN SV67-50kPa

VCN30KPa 180mL

T109

C125

T315

DIL

DIL

ICF1

C153

T289

FCM

DIL_SYRINGE

T121 C64 T130 T131

T107

SV17-50kPa T364

SV08-50kPa T299

WC1-H

C51

LF4

C49

SV09-50kPa

SV12

C124

T295

C132 T363

T334

WC1-H WC1-D WC1-R WC1-VC WC1-S

T115 SV03 T116 T117

C123

T294

SV16-50kPa T314

C140

WC1-N

C118

T288

C122

SV07-50kPa T298

C130 T306

PV01

WC1-O WC1-RC

T293

T305 SV14-50kPa T312

FCM-90kPa

DIL-CL

SP_SYRINGE

T90

C95 T168 T177

C68

T141

SV32

T236

T104

C121 T292

SV05-50kPa T296

SV06-50kPa T297

C129

SV13-50kPa T311

C113

SV66

C63 T129

T120

C128 T304

C112

T329

J9-T139-J10

T127 C62

T119

T100 DP6 2.0mL

T140

T136

SV12-50kPa OPEN

DIL-CL

RBC

C127 T303

SV12-50kPa T310

SV18-50kPa

DIL

T69

RH1HGB

C61

C126 T302

SV11-50kPa T309

T269 SV74

P1-T1-P2 T6 DR reagent container

T243

T245

T244

T246 OPEN

T369

J8-T126

C60

SV30

SV12-50kPa OPEN

10mL

J61-T85-J62

ASP_SYRINGE

VC

WC1-R OPEN

T125

J4-T101-J5

SV01-50kPa T308

T323

C83

C42 PS4

T105

T80-P9

FCM1

T178

T128

C48

T290

T147

SV20 T179

T106

C58

F

T362

VC

T74

T95

T328

SV18-N40kPa

T148

C67

TS1

SV40 J2-T92-J3

T327

SV17-N40kPa

RH1 -CL

SV02

C59

T99

T75

SV16-N40kPa

T301

LH-1

T65

T68

T103

C45

SV39

T409

T149

SV71 T227

C96

SV52

T82

C55

T410

T198

C43

RH1RBC

T77

C188

C171

C44

LPS T76

T93 T94 C187

C94 T150

C98

T89

PWD

C93 T151

T229

T70

T279

T322

C92

J27-T185-J28 T186

SV55

E

J13-T152-J14 T228

T180

T102

T88

SV38

T380

T194

T184 C97

T98

SV53

C111

T209

T381

WC1-D

T405

WC1-S

C169

T190

C52

PN

PV04/SV77

PV03/SV76

PV02/SV75

SV43

T378

T66

T87

C110 T321

T326

T320

SV06-50kPa

SV22

T67

SV54

T325

SV04-N40kPa

SV07-50kPa

T399

SV31 T401 PV07/SV78 SV37 T382 C180 J15-T163-J16 C173

穿刺汇流板

C53

SV07

C90

T153 C172

C89

C91 SV44

C99

T235

D

SV03-N40kPa

SV08-50kPa

J33-T195-J34-P26

T159 T197 C179 T398

T154 C170 T379

C88

WC1-N

WC2-S

T155 C168 T377

C87

J17-T164-J18

J48-T234-J49

WC1-O

T176

T156

J68-T404-J69 C181 T403

T375 SV36 C166 T167

T162

C109

PV02

SV75

T262 OPEN

C120 T324

SV66-N40kPa

SV06 T193

T158

T157

C86

SV33

正压废液

SV13

C80 T161

T189

PV01/SV74

C85

T402

J23-T175-J24

T376

C114

SV63

C117

OPEN SV13-50kPa

T268

OPEN

SV04-N40kPa

FCM2

FC

C167

SV14-50kPa

SV08

T160 T181

J66-T400-J67

T208 C71

T265

C186 T366

GC-90KPa 600mL

T365

PV03

SV76

C107 T250

T267

OPEN

T261

50KPa

RH1 -SH

J19-T165-J20 C182

T213

T318 GC-N40KPa 600mL T319

OPEN

T221

C72

J31-T191-J32-P25

C79

T169

SV70

T173

C

SV21

T172

C183

T222

T230

T196

SV14

90KPa

T171

DP3 1.0mL

PV04

SV77

T264

T282 GC-50KPa T287 600mL

T266

OPEN

T260 C106

C78

T170

T242

J21-T166-J22

DP2 0.5mL

T263

C105

C116

C119

T274

N40KPa

T174 C81

DP1 0.5mL

J29-T187-J30-P24

C84

J54-T240-J55 C148 J56-T241-J57

T283

PS2

T278 GC-120KPa 600mL

T214

T291

RH 3

T233 C77

T192

T272

SV27

T223

PV07

SV78

OPEN

T284 SV25 T231

T408

T259

J52-T281

PV06

SV51

T407

SV65 PS3

T27

J60-T239-P29

T226 C76

T188

J50-T271

C115 C101

T248

T258 OPEN

C184

J51-T276-J53 T247

T285 C100

T286

PV05

SV50

T255

T406

SV64

T317 T232 SV24

J25-T182-J26 C82 T183

LN

DR

T220 C75

B

T368

J59-T238-P28

T367

T219

C104 T254 C108 T253

120KPa T280

PS1

PS5

C160

RET

RH 2

C103

T252

T270 SV60

PS6

T257

OPEN C102

T251 SV61

T24

SV18-50kPa SV18-N40kPa

SV17-50kPa SV17-N40kPa

SV16-50kPa SV16-N40kPa

DIFF

RH 2

T225

RE T

WNB

SV18

C159

DI FF

SV17

WNB

SV16

C158

T256

OPEN

C141

T316

F D FN染料袋

T201

C142

SV62

T215

C73

DP01 DP11 20uL

F D FD染料袋

T200

J44-T216-J45

C74

J58-T237-P27

P22-J42

P21-J41

DP10 20uL

FR

FR染料袋

T199

SV26 J46-T217-J47

T218

SV58

SV57

DP02 DP9 20uL

P17

P23-J43

SV56

J36-T203-P14

P15

J40-T207-P20 J37-T204-P16

OPEN

P13 J35-T202-P12

LD

P1

J38-T205-P18 J39-T206-P19

A

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

1

2

3

4

5

6

7

8

MRSZ/R05N01.291.02（3.0）

A

B

C

D

E

保密密级：机密 CONFIDENTIAL

F

TITLE 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

7-31

DOC No.

BOM list of 3206 fluidics diagram A1-115-046144-00

3206 P.CODE SHEET 20 OF22

REV. SIZE

9.0

/ A3

Fluidics System 1

2

3

4

5

6

7

8

MRSZ/R05N01.291.02（3.0）

A

B

C

D

E

保密密级：机密 CONFIDENTIAL TITLE

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

BOM list of 3206 fluidics diagram

DOC No.

A1-115-046144-00

3206 P.CODE SHEET 21 OF 22

REV.

9.0

SIZE

Change description Compared with last version

EIV012

(service manual. 2.0), this version of fluidic diagram (service manual 3.0) has the

following

change:

added a Y shape connector to WC2

This version fluidic diagram

EIV013

(service manual 4.0) has the following changes: Connector C64 is changed

EIV013

from a I-shape connector to a L-shape connector

7-32

/ A3

Fluidics System

New

tube

is

added

EIV013

PharMed,1/16"IDX3/16"OD

7.13 Check the Particle Flow Stability When necessary, check the particle flow stability by looking into the particle numbers in different test channels, the PU pressure trends, and the HGB global voltage. On the “Table Review” screen, tap to select the desired sample, and tap “Stability” to check the information.

Below information/graphs are provided: The

particle

numbers

counted in

the

Tap “Setup” to configure the variation limit

DIFF/WNB/RBC/PLT test channels 250kPa/160kPa/70kPa/-40kPa trend

/

HGB Global Trend

Tap “Setup” to configure the variation limit

7-33

Fluidics System

7-34

Chapter 8 Hardware System 8.1 Hardware System Overview The hardware system is a support system for the analyzer operation. It is also a parameter sensor drive and signal detection system, and mainly includes the following functions. 

The hardware system provides a main control platform for the user end software, fluidics sequence, algorithm operation, which is the main control of the analyzer man-machine interaction and the whole system, and communicate with the PC;



The hardware system provides drive platforms and interfaces to drive the execution components such as motors, valves, pumps, to complete the test preparation of the sample collection, reaction, and delivery, and to monitor each state of the whole device during the execution process;



The hardware system provides drive and signal detection for the impedance bath, HGB sensor, optical system and other parameter sensors, obtains parameter signals then offers them to the algorithm to calculate the clinical parameters;



The hardware system provides the power supply for each module, board, and assembly;



The hardware system provides the wires for interconnection between modules, boards, and assemblies.

8.1.1 Functional block diagrams Temp. control system Heater Fan Temperature sensor

Thermal component drive and detection

Hardware system

System state monitoring

Fluidics system Valve Pump Air pressure sensor

Float sensor Hydraulic Sensor

Fluidic component drive and detection

Reagent detection

Auxiliary control embedded system platform

Signal acquisition digital processing

Dye detection

Main control embedded system platform Direct user input (key switch, touchscreen)

Direct user output (display, sound/light indication)

Data storage

Connection cable

Electromechanical system

Motor Photocoupler Micro-switch

Scanner

Motion mechanism drive and detection

Drive module

Main control module

Software System

Peripheral

Peripheral interface

USB device PC

Sensor Optical System

Optical detection principle

Count bath

Impedance detection principle

Colorimetric bath

Colorimetric detection principle

Power switch

Signal conditioning

Power conversion

Power module

Analog module

Grid power input

Figure 8-1 Functional block diagram of the hardware system

8-1

Grid power

Hardware System

8.1.2 Electrical Connection Block Diagram and the Positions in Analyzer Rotary sca nning motor(M2)

J15 J16

Autoloa der motor exte nsi on cab le 009-006 867-00

J14 Front cover Front cover detection sensor(SEN22) 009-001 198-00 Front cover protective earth wire

Key board*2（K） 051-001 568-00

Hinge bracket

J1

J1 J

LCD display 021-000 084-00 Touchscre en con trol boa rd((S) 051-000 881-00

Touch screen 021-000 005-00 PC

J1

USB pan el 042-002 231-00

J1

Indicato r b oard(G) 051-001 240-00

J1

Optical system earth wire 009-001 248-00

J13

J11

J19

P1

J38 J35/ J37

J20

Indicato r b oard connection ca ble 009-006 773-00

Optical system side co ver

J16 J50 J22 J33 J48

Syringe ea rth wire 009-002 604-00 J32

J1

Fluorescent prea mp lification boa rd(N) 051-002 783-00

Optical system base plate

Main co ntr ol b oard asse mb ly（A) 115-042 843-00

J PD board 1 051-002 814-00 J PD board 1 051-002 814-00

310 7 high an gle PD signal cable 009-002 608-00 Optical PD connection ca ble 200 9-006 809-00 Laser connection cable 310 1-21-685 93

Laser

J6 J1

J4 Optical sig nal boa rd(Q) 051-002 779-00

J4

Optical system signal cable 009-006 806-00

J3

Main co ntr ol b oard and drive boar d conn ection cable 009-006 767-00

J35

Drive b oard（C） 051-002 835-00

Laser control(L) 051-002 849-00

J42

J43 J2 J44

Laser control board connection ca ble 009-006 807-00

J2

J45

J3

J46 J51

Scanne r

Optical system NTC tempe ratu re sen sor OP T NTC temperature sensor connection cable 1 NTC te mp erature se nso r (ana lyzer te mp erature ENV, 009-006789-00 preh eating bath P RE, flow cell CELL) NTC temperature sensor connection cable 2 009-006790-00

Hyd raulic sen sor conne ction cable 009-006 793-00 Floater con nectio n cable 1 009-006 791-00

Floater con nectio n cable 2 009-006 792-00

NTC te mp erature se nso r (RBC ba th inle t diluen t RBC, DIFF b ath, RET ba th) Hyd raulic sen sor LP S Floater（WC1\WC2\LH\LD\LN\DR） Floater（DIL\FCM\N40\90KPa） Pump connection ca ble Waste container floater BNC 310 1-20-685 92

Ana log board power cable 009-006 764-00

J3

Ignition power board （R） J2 051-002 708-00

Power filte r 006-000 394-00 Power cable 002 0-20-125 22

Grounding

Switch M07-000 61S---

J2 J1 Ignition power boa rd 24V isolated inpu t ca ble power boa rd（T1） 009-007 339-00

24V power module 022-000 200-00

24V powe r module input c able 009-006 758-00 24V power module ea rth wire Power supply 009-006 759-00 assemb ly

24V power output cab le 009-006 755-00

J2

J3

Syringe motor and samp ling horizontal motor conn ection cable 009-006 781-00 Syringe motor co nnectio n cabl e 009-006 782-00 Mix assembly motor connection cable 009-006777-00 Mix mechanism sensor connection cable 009-006778-00

J4

Power conversion boa rd(D) 051-002 640-00

J6 J7

Fan co nnectio n cabl e 009-007 341-00

J12

Pump control cab le 009-008 077-00

J1

J5

J7

J8

Valve drive boa rd(F1) 051-002 805-00

J2 J4

Mix assembly cable 009-006 130-00

Syringe ea rth wire (*3) 009-002 604-00

Mix assembly shift moto r (M9), lift moto r (M10), mix motor (M11)

Mix assembly sensor （SEN4\SNE5\SEN6\SEN7\SEN8） Heater (preh eating bath PRE, DIFF b ath, RET ba th) Optical system(OPT)

Optical system earth wire(*3) 009-001 248-00

Fan

Air pump (P1_AIR), hydrau lic pump (P2_VAC, P3_WC)

Valve (14-channe l, V20V33)

Valve connection ca ble 2 009-006 799-00

Valve (18-channe l, V01V18)

J6

Valve connection ca ble 7 009-007 300-00

Valve (12-channe l, V34V45)

J1

J8

Valve connection ca ble 4 009-006 801-00

Valve (6-channe l, V46V51)

J3

Valve drive boa rd(F2) 051-002 805-00

J6

J5 J4 J2

J8

Figure 8-2 Connecting the Hardware System

8-2

Valve connection ca ble 1 009-006 798-00

Valve connection ca ble 3 009-006 800-00 Valve connection ca ble 5 009-006 802-00 Valve connection ca ble 6 009-007 299-00

Sampli ng assembly vertical motor（M7）

Syringe motor （100uL、250uL）

J3

J7

Valve drive board po we r cable 009-006 765-00

J11

Sampli ng motor sensor （SEN2\SEN3）

Sampli ng assembly horizontal mo tor（M8）

J34

J5

J9 J1

Valve drive board control cable 009-006796-00

J31

Ignition power ca ble 009-007 340-00

J1

J1

J3

Valve drive board serial connection cable 009-006 797-00

J11 J4

J28 Drive board analog power cable 009-006761-00

J9

J5

Autoloader board power cable 009-006762-00

HGB signal cable 009-006810-00

J2

Analog board control cable 009-006803-00 Analog board signal cable 009-006804-00

Drive board power digital power cable 009-006760-00

HGB se nsor

Ana log board(B) 051-002 815-00

Main co ntr ol b oard power cable 009-006 763-00

J10

Sampli ng assemb ly cable 009-006 779-00

Sampli ng assembly vertical mo tor connection ca ble009-006 780-00

J7

24V isolated power boa rd i nput cable 009-008 212-00

RBC signal cable 009-006811-00

Syringe motor se nso r（10ML、 100uL、250uL） Horizontal mo tor home position se nso r SEN1

Syringe an d samplin g motor se nsor connection ca ble 009-006 783-00

Heating co nnecti on cab le 009-006 786-00

J9

RBC count bath

Rotary sca nning compressi on mo tor(M1)

Scanne r e xtension cable 009-007 671-00

J8

J1

Micro switch（SW1\SW2）

Syringe motor （10mL）

J5

J2

J1

J8

Optical system control cab le 009-006 805-00

J3 PMT signal cable 009-006 815-00

Compression me cha nism connection cable 009-007 303-00

Liqu id dete ction boa rd Air-pressure detectio n connection ca ble boa rd con nection cable 009-006 794-00 009-006 795-00 DIFF a nd NRBC Dye se nso r conn ection cable J40 J29 Dye de tection se nso r（FD、FN） J18 009-006 784-00 Dye an d b lood sa mp le sen sor conne ction ca ble J19 Dye de tection se nso r（FR） 009-006 785-00

J24

USB cable 009-006 776-00

Autoloa der

sensor（SEN12-SEN20）

Air-pressure Liqu id dete ction boa rd(I) detectio n b oard(G) 051-000 565-00 051-000 507-00 J1 J1

J40

Touchscreen control board connection cable 009-006768-00 Network extension cable 009-002561-00

Sample compartment motor (M4)

J20

J21

Disp lay ba cklight connection ca ble 009-006 770-00

J17

Main co ntr ol b oard and autoloa der board conne ction cable 009-006 766-00

NTC temperature sensor Optical system hea ting membran e Micro-switch Micro switch connection ca ble 310 0-20-490 40

Optical assembly Front optical assemb ly

SSD hard disk signal cable 009-006771-00 Display signal connection cable 009-006769-00

J1

Mini netwo rk boa rd(H) 051-001 122-00

USB device

J14

Loa ding moto r (M5), feeding motor (M6) Unload ing mo tor (M3)

Tube fi xing de tection se nso r(SEN21)

J20

SSD hard disk power cable 009-006772-00

J

J7

J8

J18

Key micro switch connection cable 009-006774-00

J

SSD hard di sk 023-001 356-00

Autoloa der board(E) 051-002 829-00

Front cover se nsor connection ca ble 009-007 320-00

Autoloa der se nso r e xtension cable 009-006 866-00

Autoloa der motor connection ca ble 009-006 869-00 Autoloa der se nso r connection ca ble 009-006 868-00

Valve (7-channe l, V52V58) Valve (10-channe l, V60V69) Valve (10-channe l, V70V79)

Hardware System

Figure 8-3 Position of top boards

Figure 8-4 Position of front and left boards

8-3

Hardware System

Figure 8-5 Position of internal boards

Figure 8-6 Position of optical system boards

8-4

Hardware System

Figure 8-7 Position of front cover boards

Figure 8-8 Power supply assembly

8-5

Hardware System

Table 8-1 Hardware system board ID

Board name

Function

1

115-042843-00

Provides USB, display and other peripheral interfaces;

Main

control

Analog/digital conversion of analog signals (signals of optical,

board and COME

RBC/PLT, HGB, etc., and state monitoring signals of laser power,

substrate

aperture voltage, etc.)

assembly

Detection of optical shielded box micro-switches, cover sensor, other digital switching values, and so on.

2

SSD hard disk

3

051-002805-00

Valve drives

Valve drive board

Control signals come from the drive board

(2) 4

051-002640-00

Converts the 24V power supply to P24V, P12V, D5V, analog +/-

Power conversion

12V, analog +5V and others for each board

board 5

051-002835-00

Drives motors, pumps, heating mechanisms, fans and other

3206 drive board

power components; Detects the temperature, pressure, hydraulic pressure, sensors, floats, etc.

6

051-002990-00

Inputs 24V, then outputs galvanic isolation 24V and provides it to

24V

the ignition power board

isolated

power board 7

051-002708-00 Ignition

Converts the 24V power to AC120V for count bath ignition

power

board 8

9

051-002815-00

Count bath drive and RBC/PLT signal detection, HGB sensor

3206

drive and HGB signal detection;

analog

board

Outputs the optical signal to the main control board

051-002829-00

Drives and detects the autoloader motor and sensor/micro

Autoloader board

switch; Scanner communication;

10

051-000565-00

Detects diluents, lyses and other reagents;

Liquid

Outputs the air pressure detection board signal to the drive board

detection

board 11

12

051-000507-00

Detects 4-channel positive pressure, 2-channel negative

Air

pressure;

pressure

detection board

Outputs the air pressure detection board signal to the drive board

051-001122-00

Transfers the network port, one end provides users with a

8-6

Hardware System

Mini

network

network port, and the other end connects the main control board

board 13

051-002849-00

Constant power drive of the laser;

Laser

Detection of the laser drive current, laser power;

control

board 14

15

051-002783-00

Fluorescence detection sensor (SiPM) drive, preamplification of

Fluorescence

FL signal, SiPM temperature detection;

preamplification

Outputs the fluorescence drive board signal to the optical signal

board

board

051-002779-00

I/V conversion, amplification, and conditioning of the FS signal

Optical

and SS signal;

signal

board

Post-amplification and conditioning of the fluorescence signal; Outputs the optical signal to the main control board

16

17

051-002814-00

Realizes the photoelectric conversion of the FS optical signal

PD

and SS optical signal respectively, and outputs the PD mounting

mounting

board (2)

board signal to the optical signal board

051-000881-00

Detects the resistive touch screen contact position

Touch

screen

control board 18

19

20

051-001568-00

Respectively detects [RUN] key button's on/off and mode switch

Key board (2)

key's on/off

051-001240-00

Provides the analyzer status indication and alarm function,

Indicator board

including the RGB tricolor indicator array and buzzer

022-000200-00

Converts 110/220VAC power to DC 24V output

24V

power

module

8-7

Hardware System

8.2 Main control board and COME substrate assembly (115-042843-00) 8.2.1 Overview The main control board and COME substrate assembly (115-042843-00) mainly include a main control board PCBA (051-002780-00) and a COME assembly (115-047188-00). The latter is inserted into the main control board slot through a board-to-board method, mainly performs the signal acquisition (A/D conversion), data processing, system control, status detection, peripheral connection, and user interaction functions.

8.2.2 Function 

Provides sockets including USB port, network port, hard disk socket, display screen socket, touch screen socket, drive board serial interface communication and SPI socket, serial port communication socket of autoloader board, indicator board control socket, etc.;



Provides control sockets including impedance constant current source, ignition, HGB switch, laser switch, PMT voltage regulation, optical digital potentiometer adjustment and so on;



Provides the post-amplification and conditioning of optical signals, analog/digital conversion and digital processing of optical signals, impedance signals, HGB signals, and the pulse identification of optical signals;



Provides the analog-to-digital conversion of state signals (laser current, laser power, blank voltage, aperture voltage, PMT high voltage, PMT temperature, etc.)



Provides the detection of count key, mode switch key, optical shielded box micro-switches, cover 3-wire sensor and other digital switching values.

8-8

Hardware System

COME Module

mSATA socket

Analog board

ADC

Switch control socket

Drive board/ autoloader board

Communication serial port

SSD hard disk

Display screen control socket

LCD display

Touch screen control socket

Touch screen control board

IO socket

Indicator board

Switching value test

Key board（*2）

Touch screen

Mini network board

Main control board

PC

Peripheral socket USB socket*4

USB device Digital sensor

Switching value test

Micro-switch RFID card reader

RFID socket

Figure 8-9 Schematic diagram of the main control board function

8-9

Hardware System

8.2.3 Structure and Test Sockets J11

J8

J31

J

J

J16

J5

J4

J3 J18

J2

J1

J20

J21

J24

J40

Figure 8-10 Main control board socket Table 8-2 Main control board socket definition Position No. J1 J2

Socket function and definition Analog board RBC/HGB signal input socket, also includes aperture voltage signal Optical signal (FS/SS/FL) input socket, connects to the optical assembly internal board The laser control signal socket, provides power to the laser drive board

J3

and controls the laser switch, inputs the laser power signal and laser drive current signal

J4 J5

Optical signal board and fluorescence preamplification board control signal socket, mainly adjusts the signal of signal gains Analog board control signal socket, includes the constant current power switch, HGB LED switch, ignition switch

J8

Drive board socket

J11

Autoloader board socket 8-10

Hardware System

J16

Indicator board socket

J18

Cover sensor socket

J20

Key board socket

J21

Display screen control socket

J24

Touch screen socket

J31

Power socket (P12V/D5V)

J40

Display screen LED backlight socket Table 8-3 Definition of J1 analog board RBC/HGB signal input socket Pin

Signal characteristics RBC signal. The voltage is about 0.3V when measured with a multimeter

J1.3

under the standby condition

J1.7

Aperture voltage HGB signal. HGB voltage (V) displayed on the status screen = Voltage of this pin (V)*1.22*HGB gain.

J1.9

The voltage at this point is about 0.3V when the HGB signal cable is disconnected

J1.11

-5V

J1.12

+5V

J1.2/4/6

GND Table 8-4 Definition of J2 optical signal input socket

Pin J2.1 J2.3 J2.5 J2.9 J2.10 J2.12 J2.2/4/6/8

Signal characteristics FS signal. The voltage is about 83mV when measured with a multimeter under the standby condition SS signal. The voltage is about 83mV when measured with a multimeter under the standby condition FL signal. The voltage is about 83mV when measured with a multimeter under the standby condition FS blank voltage signal The voltage is about 0.1V under the normal condition PMT temperature signal PMT voltage. PMT voltage (V) displayed on the screen = Voltage of this pin (V)*12.66, which is about 1.5~2.4V under the normal condition. GND

8-11

Hardware System

Table 8-5 Definition of J3 laser control signal socket Pin

Signal characteristics Laser power monitoring voltage. The voltage is about 2V when the

J3.1

laser is on (automatically on when entering the voltage and current state screen), and is about 5.3V when the laser is off. Laser drive current monitoring voltage. The voltage is about 2.3V when

J3.2

the laser is on (automatically on when entering the voltage and current state screen), and is about 0V when the laser is off.

J3.3

GND

J3.4

+5V

J3.5

Laser switch control signal. Low level (0V) laser is on Table 8-6 J31 power socket definition

Position No.

Socket function and definition

J31.3

D5V. +4.75~5.25V

J31.4

D12V +11.5~12.5V

J31.1/2

GND

LED indicators Table 8-7 Main control board indicators Indicator position

Meaning

Normal status

D24

D5V power indicator

Green, steady on

D25

D12V power indicator

Green, steady on

D1

FPGA indicator

Green, blinking

Number

Figure 8-11 Main control board FPGA indicator 8-12

Hardware System

8.2.4 Troubleshooting Table 8-8 Troubleshooting of main control board Error

Cause

phenomenon

Troubleshooting

Power indicator

D5V/D12V power

See the "Power Module" section for

is off

supply failure

troubleshooting information.

Suspected crash,

no

response

from

the screen

Logic

error,

logic

or

burning

failed Network cable is

Network error

disconnected,

The FPGA indicator does not flash or is off. Analyzer restarts 1. Reconnect the network cable (including

or

COME module is

the mini network board) 2. Remove

failed Flickering screen,

blurred

screen

COME

module

and

reassemble it

Display cable is

Reconnect the display cable (including the

disconnected

display side)

Display cable is Display color is distorted

disconnected,

or

one of the control wires is broken, or

1. Reconnect the display cable (including the display side) 2. Replace the screen assembly

the screen is failed White screen (no

Display cable is

Reconnect the display cable (including the

content)

disconnected

display side)

1. SSD hard disk is full 2. Software failure

(such

as

time

sequence error) 3. Display Black screen

LED

backlight error, such as backlight wire disconnection ,

or

1. Empty SSD hard disk 2. Analyzer restarts 3. Reconnect the display backlight wire 4. Replace the screen assembly 5. Check the FPGA radiator

screen

failure 4. Overheat caused

by

FPGA radiator shedding 8-13

Hardware System

Flickering screen

The

(short

connection cable

black

key

board

screen) occurred

is

incorrectly

when you press

inserted into the

the count key or

touch

mode switch key

socket J24

screen

1. Touch Failed to control the touch screen

is open" alarm is reported

control cable is

(including the soft cable between the touch

disconnected

screen control board and touch screen)

2. COME module

2. Remove COME module and reassemble it 3. Replace the touch screen

Cover sensor is failed; wires are disconnected; control

The alarm is reported because it is detected that the front cover sensor is not blocked

board error

"Optical system

Micro switch in

shielding box is

the

open" alarm is

assembly

reported

incorrectly

continually

connected

System

time

error

after

startup

connector

1. Reconnect the touch screen control cable

Main

continually

consistent with that on the circuit board

screen

error "The front cover

1. Check whether the cable silk-screen is

optical is

Check the micro-switch connection in the optical assembly. Correctly insert the wire terminal into two separate pins (i.e., the middle pin is not connected). 1. Shut down and restart the analyzer after

Button used up

cell

is

the time calibration to see if the system time changes 2. Replace the button cell.

8-14

Hardware System

8.3 Drive board (051-002835-00) The drive board provides the drive for motors, valves, pumps, heating, fans etc., as well as the detection for the temperature, pressure, reagents, hydraulic pressure, sensor, floater, and micro-switches.

8.3.1 Function 

8-channel stepping motor drive;



Nearly 80-channel valve control;



1- channel fan drive



3- channel pump drive



4- channel heating drive



Sensor detection;



Float switch detection;



Fluid switching value detection;



Fluorescent dye detection



Temperature detection



Liquid pressure detection Stepping motor (8channel) Pump (3-channel)

Power component drive

Heating (4-channel) Fan (1-channel)

Digital sensors (11channel) Micro-switch (4channel) Floater (10-channel)

Drive board

Main control board

Switching value test Fluid detection board

Serial port

Photocoupler sensor

Air-pressure detection board Pressure sensor

Reagent (5-channel) Positive pressure (3channel) Vacuum (2-channel)

Analog value test Hydraulic (1-channel) NTC temperature (7channel) Analog sensors (3channel)

SPI

Valve drive board

Valve drive

Valves (48-channel)

Valve drive board

Valve drive

Valves (48-channel)

Figure 8-12 Schematic diagram of the drive board function

8-15

Hardware System

8.3.2 Structure and Test Sockets J8

J9

J11/J12

J

J12 J

J18

J19 J

J20

J45

J44

J22

J50

J43

J42

J28

J51

J29

J12 J35 J40

J34

J32

J33

Figure 8-13 Drive board socket diagram 8-16

Hardware System

Table 8-9 Drive board socket definition Position No.

Socket function and definition

J8

Heating socket

J9

Power supply socket (P24V/P12V/D5V)

J11

System fan socket

J12

Pump socket

J18

Dye sensor socket (FD, FN)

J19

Dye Sensor socket (FR) Temperature sensor socket (optical, preheating bath, flow cell,

J20

analyzer temperature)

J50

Temperature sensor socket (WBC bath, RET bath, RBC diluent)

J22

Plugging detection hydraulic sensor socket

J28

Analog power socket (A+12V, A-12V)

J29

Air-pressure detection board socket

J48

Floater socket (DIL\FCM\N40)

J33

Floater socket (WC1\WC2\LH\LD\LN\DR)

J32

Sensor socket (10ML\100Ul\250uL\SEN1\SEN2\SEN3)

J51

Mix assembly sensor socket (SEN4\SNE5\SEN6\SEN7\SEN8)

J34

Valve drive board socket

J35

Main control board socket

J40

Liquid detection board socket

J42

Motor socket (vertical motor)

J43

Motor socket (horizontal motor/10ml syringe motor)

J44

Motor socket (100ul/250ul syringe motor) Motor socket (mix assembly shift motor (M9)/lift motor (M10)/mix

J45/J46

motor (M11)) Table 8-10 Drive board J9 power supply socket definition

Position No.

Socket function and definition

J9.1/2

P12V. +11.5~12.5V

J9.3

D5V. +4.75~5.25V

J9.4/5

P24V. +22.8~25.2V

J9.6/7/8/9/10

GND

Table 8-11 Drive board J28 analog power socket definition Position No.

Socket function and definition

J28.1

A+12V. +11.5~12.5V

J28.2

GND

J28.3

A-12V. -11.5~12.5V

8-17

Hardware System

LED indicators Table 8-12 Indicators on the drive board Indicator position

Meaning

Normal status

D16

P12V power indicator

Green, steady on

D17

P24V power indicator

Green, steady on

D18

A+12V power indicator

Green, steady on

D19

A-12V power indicator

Green, steady on

D22

A+5V power indicator

Green, steady on

D96

D5V power indicator

Green, steady on

D66

MCU indicator

Green, steady on

D65

MCU indicator

Green, blinking

D94

FPGA indicator

Green, blinking

number

Figure 8-14 Indicators on the drive board

8-18

Hardware System

8.3.3 Troubleshooting Table 8-13 Drive board troubleshooting Error

Cause

phenomenon External power

Troubleshooting

input indicator

(D16/17/18/19/9

External

input

power is in error

See the "Power Module" section for troubleshooting information.

6) off Intra-board conversion

Drive board A+5V

power

power failure

indicator

operation

Logic logic

Temperature out upper

alarm

or

burning

failed 1.

of

error,

limit

cable on the drive board. If the indicator is still off, the drive board is damaged.

(D22) off Abnormal motor

Unplug the signal cables except the power

The FPGA indicator does not flash or is off. Analyzer restarts

Temperature

sensor

cable

is

1. Check

disconnected/brok en 2.

the

connection

cable

and

reconnect it 2. Replace the temperature sensor or

Temperature

drive board

sensor failure

8-19

Hardware System

8.4 Analog board (051-002815-00) 8.4.1 Function The analog board provides the drive and signal detection for the count bath and HGB sensor.

Analog Board Count bath

Main Control Board ADC

Sensor drive Signal amplified conditioning

HGB sensor

Figure 8-15 Schematic diagram of the analog board function

8.4.2 Structure and Test Sockets

Figure 8-16 Analog board socket diagram Table 8-14 Analog board socket definition Position No. J1

Socket function and definition Laser control board power output socket. HGB LED is off when unplugged

8-20

Hardware System

Analog board control signal socket (HGB LED switch, constant current

J2

power switch, ignition switch)

J3

A+12V/A-12V/A+5V analog power input socket

J4

AC120V ignition power input socket

J7

Power output socket of optical signal board

J9

HGB sensor socket

J10

RBC sensor socket (in the shielding box)

J11

RBC/HGB signal output socket, connected to the main control board Table 8-15 Analog board J3-analog power input socket definitions

Position No.

Socket function and definition

J3.1

A+12V. +11.5~12.5V

J3.2

GND

J3.3

A+5V.+4.75~5.25V

J3.4

A-12V. -11.5~12.5V

Table 8-16 Analog board J1-laser control board power output socket definitions Position No.

Socket function and definition

J1.1

A+12V. +11.5~12.5V

J1.2

GND

J1.3

A-12V. -11.5~12.5V

Table 8-17 Analog board J7- optical signal board power output socket definitions Position No.

Socket function and definition

J7.1/5

A+12V. +11.5~12.5V

J7.2/4

A-12V. -11.5~12.5V

J7.3/6

GND

J7.7

A+5V. +4.75~5.25V

J7.8

A-5V. -4.75~5.25V Table 8-18 Analog board J11-RBC/HGB signal output socket definitions

Position No.

Socket function and definition

J11.2

HGB signal. The voltage is about 0.3V when the HGB LED is off

J11.6

RBC signal. The voltage is about 0.3 V in the standby status

J11.11

A-5V. -4.75~5.25V

J11.12

A+5V. +4.75~5.25V

J11.10

GND

8-21

Hardware System

LED indicators Table 8-19 Indicators on the analog board Indicator position

Meaning

Normal status

D8

A+12V power indicator

Green, steady on

D9

A-12V power indicator

Green, steady on

D10

A+5V power indicator

Green, steady on

D11

A-5V power indicator

Green, steady on

Number

Figure 8-17 LED indicators position on an analog board

8.4.3 Troubleshooting Table 8-20 Analog board troubleshooting Error

Cause

phenomenon External power

input indicator

(D8/9/10) off Conversion power

(in

the

board) indicator (D11) off

External

Troubleshooting input

power is in error Analog board A5V power is in error

See the "Power Module" section for troubleshooting information. Remove all the signal cables on the analog board except for the analog power line. If the indicator is still off, the analog board is damaged.

8-22

Hardware System

8.5 Autoloader Board (051-002829-00) The autoloader board completes driving of the related motor and scanner of automatic sampler, and detection of the sensor and micro-switch.

8.5.1 Function

Autoloader Motor drive

Main Control Board

Serial port

Stepping motor (6-channel) Digital photocoupler (10channel)

Digital value test

Micro-switch (2-channel) Analog value test

Autoloader board

Analog sensor (1-channel)

Serial port

Scanner

Figure 8-18 Function diagram of autoloader board

8.5.2 Structure and Test (1) Sockets

8-23

Hardware System

Figure 8-19 Interface diagram of autoloader board Table 8-21 Autoloader board sockets definitions Position No.

Socket function and definition Autoloader sensor and micro-switch sockets (SEN12-SEN21 and

J7/J8

SW1/SW2)

J14/J15/J16

Autoloader motor socket (M2/M3/M4/M5/M6) Autoloader

J17

motor

socket

(rotatory

scanning&compressing

motor(M1)) Serial port communication socket (connected to the main control

J19

board) P24V power input socket (P12V and D5V output sockets are also

J20

reserved)

P1

Scanner socket Table 8-22 Autoloader J20 power socket definitions

Position No.

Socket function and definition

J20.1

P24V. +22.8~25.2V input

J20.2

GND

J20.3

P12V. +11.5~12.5V

J20.5

D5V. +4.75~5.25V

(2) LED indicators

Figure 8-20 LED indicators positions on autoloader board Table 8-23 Autoloader indicators Indicator position

Meaning

Normal status

D5

P24V power indicator

Green, steady on

D8

P12V power indicator

Green, steady on

D9

D5V power indicator

Green, steady on

D20

MCU indicator

Green, blinking

D21

FPGA indicator

Green, blinking

Number

8-24

Hardware System

8.5.3 Troubleshooting Table 8-24 Troubleshooting autoloader board Error

Cause

phenomenon External power

input indicator

(D5) off

External

Troubleshooting input

power is in error

Intra-card conversion

P12V

power

power are in error

indicator

and

D5V

(D8/D9) off

See the "Power Module" section for troubleshooting information. Remove all the signal cables on the board except for the power cord. If the indicator is still off, the autoloader board is damaged.

MCU Autoloader motor operation exception

software/FPGA

The MCU software /FPGA indicator does

logic

not blink or is off.

or

abnormal MCU

software/FPGA

Restart the machine. If the problem can't be solved, replace the autoloader board.

logic burning fails

8-25

Hardware System

8.6 Valve Drive Board (051-002805-00) 8.6.1 Function The valve drive board controls multiple -valves. The 12V power for the drive board is supplied by the motherboard, and the control signals are from drive control board. Two valve drive boards are used in the instrument, which are exactly the same and are exchangeable during service.

Valve drive board (F1) Valve control socket

Control socket

Drive board

Valve Valve drive Valve

Valve drive board(F2) Valve control socket

Valve Valve drive Valve

Figure 8-21 Valve drive boards series connection diagram

8.6.2 Structure Valve connection cable 1 009-006798-00

Valves (14-channel, V20-V33)

J3

J2 J4 J6

Valve connection cable 2 009-006799-00 Valve connection cable 7 009-007300-00

Valves (18-channel, V01-V18) Valves (12-channel, V34-V45)

J1

J8

Valve connection cable 4 009-006801-00

Valves (6-channel, V46-V51)

J7

J6

Valve connection cable 3 009-006800-00 Valve connection cable 5 009-006802-00 Valve connection cable 6 009-007299-00

Valves (7-channel, V52-V58) Valves (10-channel, V60-V69) Valves (10-channel, V70-V79)

J1

J5

J7

J8

Valve drive board (F1) 051-002805-00

Valve drive board(F2) 051-002805-00

J3

J5

J4 J2

Figure 8-22 Valve connection diagram

8-26

Hardware System

8.6.3 Troubleshooting Table 8-25 Troubleshooting for the valve control errors Error

Cause

phenomenon

Troubleshooting 1. Exchange the drive boards for the 2 same valves, and then switch on and off the problem valve to see whether it can be

Control

of

a

single valve fails

The most possible cause is that the valve is damaged

controlled, If yes, then the valve drive board fails; 2. If the valve still cannot be controlled, connect the valve to the other valve control line, and switch it on/off. If the valve still cannot be controlled, the valve is damaged; otherwise, the problem is with the cables. 1. Check whether the failed valves are

The most possible Control

of

cause is that the

consecutive

valve drive board

valves fails

fails or poor cable connection.

connected to the same valve connecting cables. If yes, the valve connecting cables connection may be bad (try to remove the error by unplug and then plug the line again), or the valve drive board fails (replace a valve drive board to confirm if it is the reason) 1. Check whether the valve drive board power

The most possible Control

of

valves fails

all

cause is that the valve drive board fails or poor cable connection.

cord and valve drive board control cable are good; and plug and unplug the cables 2. Connect the valve drive board control cable to the other valve drive board and observe valve control status. If control of some valves is effective, then the original valve drive board fails.

8-27

Hardware System

8.7 Power Supply Module 8.7.1 Overview The power supply module converts the grid voltage to voltages for the board card power supply and for all components. It consists of the 24V power supply module (022-000200-00), power conversion board (051-002640-00), 24V isolated power board (051-002990-00) and the 3206 power board PCBA for burning (051-002708-00). The module outputs various power of P24V, P12V, D12V, D5V, A+12V, A-12V, A+5V, AC120V etc.to the drive boards, main control boards, analog boards, valve drive boards, autoloader boards and other boards. The 24V power supply module supports 100~240V wide power input and outputs DC 24V. The power conversion board realizes the conversion of the main power. The +24V DC input and +24V DC output of the 24V isolated power board are electrically isolated. The 3206 power board PCBA for burning converts the isolated DC 24V output by the isolated power board into AC 120V, and then provides it to the count bath through the analog board for burning. P12V

P24V

Valve drive board

Autoloader Board

P24V P24V

P12V D5V

P12V D12V Power cable AC220V/110V

+24V 24V Power module

Power conversion board

Power supply assembly

Drive board

A+12V A-12V

D5V

D12V

A+12V

D5V

A-12V

A+12V A-12V

A+5V

A+5V

Main control board

Analog Board

AC120V

+24V

DC24V 24V isolated power board

Ignition power board

AC120V

Figure 8-23 Power supply module composition Table 8-26 Working power supplies of the main cards and components Power supply P24V

Supplying board Drive board, autoloader board, isolated

Purpose Motor, heating

power board P12V

Drive board, valve drive board

Valve, pump and fan drive

D12V

Main Control Board

COME module, display screen

D5V

Drive board, main control board

Digital circuit

A+12V

Analog board, drive board

Analog circuit

A-12V

Analog board, drive board

Analog circuit

A5V

Analog board

Analog circuit

AC120V

Analog board

Power supply for burning in the count bath 8-28

Hardware System

8.7.2 Structure and Test Notes: The red connection cords between the boards are the power cord. All the GNDs described in the following content connect to the main unit housing. Therefore, when using a multimeter to measure the voltage, insert the black probe to the housing. Table 8-27 Normal voltage ranges and measurement methods Type of power supply +24V

Normal voltage

Measurement method

range +22.8~25.2V

Use the multimeter DC mode to measure the J1 position of the isolated power board

P24V

+22.8~25.2V

Use the multimeter DC mode to measure the J9

P12V

+11.5~12.5V

position of drive board

D12V

+11.5~12.5V

Use the multimeter DC mode to measure the J31

D5V

+4.75~5.25V

position of main control board

A+12V

+11.5~12.5V

A-12V

-11.5~12.5V

Use the multimeter DC mode to measure the J3

A5V

+4.75~5.25V

position of analog board

DC24V

+22.8~25.2V

Use the multimeter DC mode to measure the pin1 and 3 of J2 on the isolated power board

AC120

+108~132V

Use the multimeter AC mode to measure the two terminals of J4 on the analog board

(1) Measure +24V and isolated DC24V Measure the +24V voltage at the input socket of the 24V isolated power board, where the +24V is directly connected. To measure the isolated DC24V, measure the voltage between pin1 and pin3 of the output socket of isolated power board. Note: Since DC24V and instrument do not share the same ground, when measuring DC 24V, the method of using the black probe of multimeter to measure the housing and the red probe to measure the output socket of isolated power board cannot be used to measure DC24V.

8-29

Hardware System

Figure 8-24 Measure +24V and isolated DC24V on the isolated power board (2) Measure P24V and P12V

Figure 8-25 Measure P24V, P12V, D5V, A+12V and A-12V on the drive board 8-30

Hardware System

(3) Measure D12V and D5V D12V and D5V power the main control board and can be measured at the power input socket J31 of main control board.

Figure 8-26 Measure D12V and D5V on the main control board (4) Measure A+12V, A-12V and A5V Connect A+12V, A-12V and A5V to the analog board. They can be measured conveniently at the analog power input socket J3 of analog board.

8-31

Hardware System

Figure 8-27 performing A+12V\A-12V\A5V measurement on the analog board (5) Measure the AC120V for zapping Use the multimeter AC mode to measure the voltage on AC120V input socket J4 on the analog board. Warning: High voltage! During measurement, DO NOT touch the power connector with your hand!

Figure 8-27 Measure AC120V on the analog board 8-32

Hardware System

(6) Measure the voltages on the power conversion board All the power come from the power conversion board. Therefore you can also measure the voltages on the corresponding sockets of the power conversion board. Read the socket number silkscreen on the board to find the desired sockets.

Figure 8-28 Power output sockets on the power conversion board

Figure 8-29 Definitions of the power sockets on the power conversion board (see the silk screen) 8-33

Hardware System

Note: The white triangular symbol besides the board connector indicates pin 1.

8.7.3 Power Indication The LED indicators on various power supply boards indicate the power on/off status. Note: The LED indicator status only reflects whether there is power or not; they do not show whether the voltages are in their normal ranges. (1) Power conversion board indicators There are six green LED indicators on the power conversion board, indicating the main power supply indicator. Table 8-28 Power conversion board indicators Indicator position

Meaning

Normal status

D1

A5V power indicator

Green, steady on

D3

A-12V power indicator

Green, steady on

D4

A+12V power indicator

Green, steady on

D5

D5V power indicator

Green, steady on

D1~D6

+24V/P24V power indicator

Green, steady on

D7

P12V power indicator

Green, steady on

Number

Figure 8-30 Power conversion board power indicators

8-34

Hardware System

(2) Drive board power indicators Table 8-29 Indicators on the drive board Indicator position

Meaning

Normal status

D16

P12V power indicator

Green, steady on

D17

P24V power indicator

Green, steady on

D18

A+12V power indicator

Green, steady on

D19

A-12V power indicator

Green, steady on

D22

A+5V power indicator

Green, steady on

D96

D5V power indicator

Green, steady on

Number

Note: The A+5V power supply is obtained through power conversion in the drive board.

Figure 8-31 Power indicators on the drive board (3) Main control board power indicators Table 8-30 Indicators on the main control board Indicator position

Meaning

Normal status

D24

D5V power indicator

Green, steady on

D25

D12V power indicator

Green, steady on

Number

8-35

Hardware System

Figure 8-32 Power indicators on the main control board (4) Analog board power indicators Table 8-31 Indicators on the analog board Indicator position

Meaning

Normal status

Number D8

A+12V power indicator

Green, steady on

D9

A-12V power indicator

Green, steady on

D10

A5V power indicator

Green, steady on

D11

A-5V power indicator

Green, steady on

Note: The A-5V power is obtained through power conversion in the analog board.

Figure 8-33 Power indicators on the analog board 8-36

Hardware System

8.7.4 Troubleshooting Power supply faults usually manifest as instrument power down or abnormal output of a certain channel of power causing by short circuit and open circuit. Table 8-32 Troubleshooting of the power supply Error

Cause

phenomenon

Troubleshooting 1. First confirm whether the instrument is powered down. In this case, the screen should blank out and all the boards’ indicators should be off.

Usually caused by

2. Unplug the input power cord to each board

+24V short circuit,

to identify whether they are short circuited.

Instrument

triggering

short

Check the boards one by one until you find

powers down

circuit

protection

the failed one. Since 24V is mainly provided

of the 24V power

to the drive board, autoloader board and

supply module.

isolated power board, check these boards first. 3. After you identified the problem board, check whether the short circuit happens in motor, heater or on the board itself. 1. Phenomenon: This power supply has no voltage and the indicator lights off; the other power supplies are normal. (In particular, if only the P24V or P12V

Single

power

supply

powers

down

Short circuit of this

output is abnormal, the instrument will

single

power

report error (the other supplies are not

supply

causes

short

circuit

protection or open circuit

of

the

monitored).) 2. Use the same method as above to check the power supply status. 3. In particular, if the indicator of this power

corresponding

supply on the power conversion board is on,

power

but the indicators on the other boards are

circuit.

converter

off, it is caused by open circuit. Open circuit may be caused by poor cable connection, broken cable, or fusing of board fuse. If the fuse burns out, then there is also short circuit on the board.

8-37

Hardware System

8.8 Boards in the Optical System 8.8.1 Function The boards in the optical system include the laser control board, PD board, fluorescent front board and optical signal board, which respectively implement constant power driving of laser, and collection, amplification and conditioning of the three channels of optical signals (FS, SS and FL), and then transmit them to the post stage main control board for analog/digital conversion. The power supply is provided from the analog board, including A+/-12V and A+/5V.

Ana log Board

Fluorescence preamplification board

Lateral fluorescence

Optical sig nal board

Main co ntr ol boa rd

PD board (FS)

Forward scatter

PD board (SS)

Lateral sca tter

Laser control board

Laser Optical System

Figure 8-34 Boards in the optical system

8-38

Hardware System

8.9 Indicator Board (051-001240-00) 8.9.1 Function The indicator board uses a tri-color indicator (red/yellow/green) and a buzzer to indicate the main unit working status. When the system is standby, the tri-color indicator is in yellow; when the system is working properly, the tri-color indicator is in green; and when the system is with error, the tri-color indicator is in red. When the system works properly, the buzzer is silent; but when there is any error with the system, the buzzer buzzes. The indicator board is directly connected to and controlled by the main control board.

8.9.2 Troubleshooting Phenomenon: The indicator is off or abnormal and the buzzer sounds abnormally. Possible causes: poor cable connection of the indicator board; the indicator board is damaged; the main control board is damaged.

8-39

Hardware System

8.10 Keyboard (051-001568-00) 8.10.1 Function There are two keyboards, one for the Start key (K1) and the other for the mode switch key. Keypad bo ard （K1) Main co ntr ol b oard

Microswitch

Start key

Switch detectio n

Keypad bo ard （K2) Mode switch key

Microswitch

Figure 8-35 Keyboard function diagram

8.10.2 Troubleshooting Table 8-33 Troubleshooting for keyboard errors Error

Cause

phenomenon

Troubleshooting

When the count key is pressed, the

sample

compartment opens; when the mode switch key is

pressed,

The

keypad

cables for K1 and K2 are reversely

Exchange the cables of the two keyboards.

connected.

sample analysis starts.

8-40

Hardware System

8.11 Mini Network Board (051-001122-00) 8.11.1 Function The mini network board divides the communication channel between the main control board and the PC into 2 segment. It acts as the connecting point of the external network cable and the network cable inside the instrument. And it offers two RJ45 connectors to connect the corresponding ports inside and outside the instrument. See the figure below.

Figure 8-36 Mini network board function diagram

8.11.2 Troubleshooting The fault possibility of the small network board is very low. The network disconnection fault related to it is usually caused by poor connection of the network cable. The fault can be eliminated according to the method in the following table. Table 8-34 Network troubleshooting Error

Cause

phenomenon 1. The PC cannot communicate with series

the

6000

analyzer

main unit.

The

cable

Troubleshooting

network is

not

properly

Check if the network cable connector gets loose.

connected;

If yes, reconnect the cable and see if the

2. The cable is

problem is solved

damaged

or

in

poor contact with the socket.

8-41

Hardware System

8.12 Liquid Position Detecting Board (051-000565-00) 8.12.1 Function The liquid position detection board is used to detect the reagents such as DIL Diluent, LH lyse, LN lyse, LD lyse and DR diluent. The principle is to use a sensor to detect whether there is liquid in the pipe. When there is liquid in the pipe, high light intensity is detected for the light transmission, and a high level is output; when there is no liquid (but only air or bubbles) in the pipe, only weak light is received due to light refraction, and low high level is output. The liquid position detection board output is connected to the drive board.

8.12.2 Structure and Test Each type reagent, there is an LED indicator to indicate reagent volume status. When the indicator is on, there is no liquid in the corresponding reagent pipe.

Figure 8-37 LED indicators on the liquid position detection board Table 8-35 Liquid position detection board indicators Indicator

Meaning

Normal status

position Number D1

DIL Diluent indicator

Yellow, always off. Light on when there is no reagent

D2

Yellow, always off. Light on when

LH lyse indicator

there is no reagent D3

Yellow, always off. Light on when

LN lyse indicator

there is no reagent D4

Yellow, always off. Light on when

LD lyse indicator

there is no reagent D5

DR diluent indicator

Yellow, always off. Light on when there is no reagent

D7

5V power indicator

8-42

Red, steady on

Hardware System

8.12.3 Troubleshooting Table 8-36 Troubleshooting the liquid position detection board Error

Cause

phenomenon

Troubleshooting

Poor cord contact, Power indicator is off

or liquid position

Remove and insert the wire again. If the

level board is in

restarting operation does not work, replace the

fault, or the drive

liquid level board or drive board.

board is in fault 1. Check to confirm if this reagent pipe is filled with fluid and there are no bubbles, but the corresponding

indicator

on

the

liquid

position detection board is on. 2. Take out the transparent object from the corresponding reagent sensor on the liquid

Unavailability of a reported mistake

reagent by

Fluid

detection

board error

position detection board, and check if the indicator

changes

when

blocking/not

blocking the sensor. If the indicator is always on or off without any change, replace the liquid position detection board. (Note: Most liquid position detection board faults are caused by leakage corrosion of the board. Check the board surface for reagent trace.)

8-43

Hardware System

8.13 Air Pressure Detection Board (051-000507-00) 8.13.1 Function The air pressure detection board uses the BC-6800 series analyzers' air pressure detection board to detect the +120 kPa (two channels), +90 kPa, +50 kPa, -30 kPa and -40 kPa air pressures. The air pressure detection board obtains the power supply through the drive board, and its output signal is transmitted to the drive board to implement analog-digital acquisition. Air pressure detection board

ADC Drive board

Figure 8-38 Air pressure detection board connection block diagram

8.13.2 Structure

Power indicator

Figure 8-39 Air pressure detection board layout diagram Table 8-37 Air pressure detection board indicator definitions Indicators

Definition

Function The LED indicator stays on under normal conditions. If this indicator is off, the analog +5V power supply of the air

D1

A+5V power supply

pressure detection board is abnormal. Check whether the

indicator

connection line between the air pressure detection board and drive board is inserted firmly or whether the analog +5V voltage of drive board is normal.

D2

Digital

3.3V

power

supply indicator

The LED indicator stays on under normal conditions. If this indicator is off, the digital 3.3V power supply of the air pressure detection board is abnormal. Check whether the 8-44

Hardware System

connection line between the air pressure detection board and drive board is inserted firmly or whether the digital 3.3V voltage of drive board is normal.

8.13.3 Troubleshooting Error with the air pressure detection board will cause abnormal pressure of the whole device and trigger error alarms. When the analyzer reports error of "abnormal pressure", follow the troubleshooting procedure below. Abnormal pressure of the analyzer

Error of all channels

N

Y

1. Check whether the pipeline is correctly connected

Check faulty channel pipeline

1. Check whether the air pressure detection board analog 5V indicator is on; 2. Check whether the drive control board analog power indicator is normal.

1. Reconnect the cable. If the fault is cleared, the maintenance is over; otherwise, go to step 2; 2. Replace the air pressure detection board. If the fault is cleared, the maintenance is over; otherwise, go to step 3; 3. Replace the drive board. If the fault is cleared, the maintenance is over; otherwise, go to step 4; 4. Replace the cable.

Any crystal or liquid in pipeline?

N

Y Replace air pressure detection board

Check pipeline leakage

Repair pipeline

End

Figure 8-40 Maintenance flows when the analyzer reports pressure errors The major factor of an air pressure detection board fault is failure of the pressure sensor, which occurs because impurities or fluid enters the sensor. Now, the fault cannot be eliminated by wiping the impurities or fluid, and the only way is to replace the board.

8-45

Chapter 9 FRU Replacement and Debugging 9.1 Overview This chapter introduces the FRU replacing procedures, and the corresponding FRU codes. The requirements for FRU replacing and servicing are as follows: 

For any service procedure involving electric parts, the power shall be switched off, and measures shall be taken to prevent statical electricity



For any service procedure involving fluidics, pay attention to the fluid inside the fluidic tubes. While servicing any piping with pressure, make sure you turn off the pneumatic unit before plugging/unplugging or replacing piping. Using tissue for protection during the service;



After the service is completed, restart the system and wait for the completion of the startup fluidic initialization. Confirm that the system is in a proper state after startup, and then run several fresh blood samples to make sure the instruments are in good state;



For important service related to performance or parameter result, make sure you re-adjust the gain or re-calibrate the system before putting it into use again. For example, after the service of the optical system, it is needed to re-adjust the optical gain, and re-calibrate the system. For other FRUs such as analog board and aperture, re-calibration is also needed after maintenance.

9-1

FRU Replacement and Debugging

9.2 Removal and Installation of the Panels 9.2.1 Opening the Front Cover Assembly 

Purpose:

The fluorescence reagent detection sensor, dosing pumps for fluorescent reagents, front cover open detection sensor, diluent preheating bath, rotatory scanning unit and autoloader control board are located on the front panel rack behind the housing. Sometimes these components need to be maintained. 

Tools

/ 

Removal

1

Power off the instrument, and then remove the power cord of main unit;

2

If the sample compartment is open, close it (skip this step if the sample compartment is closed or when you are dealing with an open-vial sampling model analyzer);

3

Use a hand to pull the right side of front cover to open it, as shown in Figure 9-1.

Figure 9-1 Opening the front cover assembly

9-2

FRU Replacement and Debugging



Installation Install the assembly in the reversed order of the disassembly steps.



Verification

1

Try to pull the front cover assembly to check whether it is firmly closed.

2

Plug the power cord, and start the instrument. Make sure it starts up normally.

9.2.2 Opening the Left Panel, Right Panel and Top Cover 

Purpose

To service/replace the circuit boards (including the main control board, analog board, valve drive board and power board PCBA for burning) or their cables, remove the top cover; to service/replace the syringes and valves, remove the left panel; to service/replace the reaction baths and the sample probe assembly, as well as certain valves and the power supply unit, remove the right panel. 

Tools

107 Phillips screwdriver (107X75) 

Removal

1

Power off the instrument, and then remove the power cord of main unit;

2

Open the front cover. To facilitate operation, the opening angle cannot be smaller than 60°;

3

Use a 107 Phillips screwdriver (107X75) to unscrew the 6 cross round head combination screws fixing the right panel (marked in the red rectangle in below diagram), and take out the left panel;

4

Use a 107 Phillips screwdriver (107X75) to unscrew the 6 cross round head combination screws locked on the left door in the red box of the following diagram, and take out the right door;

5

Use a 107 Phillips screwdriver (107X75) to unscrew the 3 cross round head combination screws fixing the right panel (marked in the red rectangle in below diagram), and take out the top cover.

9-3

FRU Replacement and Debugging

Figure 9-2 Instrument after removing the left panel, the right panel and the top cover 

Installation

Install the assembly in the reversed order of the disassembly steps. 

Verification

Try to pull the left panel, right panel and top cover to check whether they are closed and locked firmly.

9-4

FRU Replacement and Debugging

9.3 Replacing the Autoloader FRU BC-6000 series analyzers have two types of autoloaders, one for the Open-sampling type, and the other for the closed-sampling model. Both types have the loading assembly, feeding assembly, back supporting board assembly and the unloading assembly. When servicing the loading assembly, feeding assembly and loading assembly, the sample transportation platform must be removed first. See the figure below for the open-sampling type autoloader removing procedure:

See the figure below for the closed-sampling type autoloader removing procedure:

9-5

FRU Replacement and Debugging

9.3.1 Removing and Replacing the Loading Motor and Belt 

Tools

107 Phillips screwdriver 1.5 mm small inner hexagon spanner Tension measuring device 

Procedures

Removal: 1

Remove the cables connected to the motor;

2

Use a Phillips screwdriver to unscrew the 2 M3x8 screws fixing the belt clamp, and then unscrew the 4 M3x8 screws; then, incline the motor inward in the axis direction, remove the belt directly, and take out the motor together with the large pulley;

3

Use a 1.5 mm small inner hexagon spanner to take out the two lock screws of the large pulley, and separate the large pulley from the motor.

Installation: 1

Install the synchronous belt, adjust the synchronous belt tension to 7±2 N and belt width to 6.4 mm, and then tighten the belt. Use M3x5 inner hexagon screws to fix the motor. The motor wire outlet direction is shown in the figure.

2

Check whether the lock screws on the pulley get loose. If yes, adjust the spacing between 9-6

FRU Replacement and Debugging

the pulley and motor to about 0.5 mm, and then fasten the lock screws on the pulley.

Figure 9-3 Remove motor and belt No.

Name

1

M3x8

cross

head

combination

pan

FRU code

No.

Name

FRU code

M04-

4

Small pulley

BA30-21-

051140---

06582

screw 2

Synchronous

3

belt

M6C-

160MXL025

020003---

Inner hexagon set

M04-

screw with cup point

051102---

5

Motor

024-000863-00

9.3.2 Removing and Replacing the Loading Sensor 

Tools

107 cross-head screwdriver Nipper pliers 

Procedures

Removal: 1

Remove the cables connected to the sensor;

2

Use a cross-head screwdriver to remove the M4x12 screws fixing the sensor, and remove the sensor

Installation: 1

Install the sensor, and use the cross-head screwdriver to tighten the M4x12 screws.

2

Connect the cables.

9-7

FRU Replacement and Debugging

Figure 9-4 Removing and replacing loading sensor No.

Name

1

M4x12

FRU code cross M04-051152---

No.

Name

FRU code

2

Sensor

011-000021-00

panhead screw

9.3.3 Removing and Replacing the Feeding Motor and Belt 

Tools

107 Phillips screwdriver 1.5 mm small inner hexagon spanner Tension measuring device 

Procedures

Removal: 1

Remove the cables connected to the motor;

2

Use a Phillips screwdriver to unscrew the 2 M3x8 screws fixing the belt clamp, and then unscrew the 4 M3x8 screws; then, incline the motor inward in the axis direction, remove the belt directly, and take out the motor together with the large pulley;

3

Use a 1.5 mm small inner hexagon spanner to take out the two lock screws of the large 9-8

FRU Replacement and Debugging

pulley, and separate the large pulley from the motor. Installation: 1

Install the synchronous belt, adjust the synchronous belt tension to 7±2 N and belt width to 6.4 mm, and then tighten the belt. Use M3x5 inner hexagon screws to fix the motor. The motor wire outlet direction is shown in the figure.

2

Check whether the lock screws on the pulley get loose. If yes, adjust the spacing between the pulley and motor to about 0.5 mm, and then fasten the lock screws on the pulley.

Figure 9-5 Remove the motor and belt No.

Name

1

M3x8

cross

head

combination

pan

FRU code

No.

Name

FRU code

M04-

4

Small pulley

BA30-21-

051140---

06582

screw 2

Synchronous

belt

160MXL025 3

Inner screw

hex

M6C-

5

020003--lock

M04051102---

9-9

Motor

024-000863-00

FRU Replacement and Debugging

9.3.4 Removing and Replacing the Feeding sensor 

Tools

107 cross-head screwdriver Nipper pliers 

Procedures

Removal: 1

Remove the cables connected to the sensor;

2

Use a cross-head screwdriver to remove the M4x12 screws fixing the sensor, and remove the sensor

Installation: 1

Install the sensor, and use the cross-head screwdriver to tighten the M4x12 screws.

2

Connect the cables.

Figure 9-6 Remove and replace the loading sensor No.

Name

1

M4x12

cross

FRU code

No.

Name

FRU code

M04-051152---

2

Sensor

011-000021-00

panhead screw

9.3.5 Removing and Replacing the Unloading Motor and Belt 

Tools

107 Phillips screwdriver 1.5 mm small inner hexagon spanner Tension measuring device 

Procedures

Removal: 9-10

FRU Replacement and Debugging

1

Remove the cables connected to the motor;

2

Use a Phillips screwdriver to unscrew the 2 M3x8 screws fixing the belt clamp, and then unscrew the 4 M3x8 screws; then, incline the motor inward in the axis direction, remove the belt directly, and take out the motor together with the large pulley; Use a 1.5 mm small inner hexagon spanner to take out the two lock screws of the large

3

pulley, and separate the large pulley from the motor. Installation: Install the synchronous belt, adjust the synchronous belt tension to 7±2 N and belt width

1

to 6.4 mm, and then tighten the belt. Use M3x5 inner hexagon screws to fix the motor. The motor wire outlet direction is shown in the figure. Check whether the lock screws on the pulley get loose. If yes, adjust the spacing between

2

the pulley and motor to about 0.5 mm, and then fasten the lock screws on the pulley.

Figure 9-7 Remove motor and belt No.

Name

FRU code

No.

Name

FRU code

1

M3x8 cross pan head

M04-051140---

4

Inner hex lock

M04-051102---

combination screw 2 3

Synchronous

screw belt

M6C-020003--

160MXL025

-

Small pulley

BA30-21-

5

Motor

024-00086300

06582

9-11

FRU Replacement and Debugging

9.3.6 Removing and Replacing the Unloading Sensor 

Tools

107 cross-head screwdriver Nipper pliers 

Procedures

Removal: 1

Remove the cables connected to the sensor;

2

Use a cross-head screwdriver to remove the M4x12 screws fixing the sensor, and remove the sensor

Installation: 1

Install the sensor, and use the cross-head screwdriver to tighten the M4x12 screws.

2

Connect the cables.

Figure 9-8 Remove and replace the loading sensor No.

Name

1

M4x12

FRU code cross

panhead screw

No.

M04-

Name 2

051152---

Sensor

FRU code 011000021-00

9-12

FRU Replacement and Debugging

9.3.7 Removing and Replacing the Back Supporting Board 

Tools

107 cross-head screwdriver Nipper pliers 

Procedures

Removal: 1

Remove the cables connected to the sensor;

2

Use a cross-head screwdriver to remove the M4x12 screws fixing the sensor, and remove the sensor

Installation: 1

Install the sensor, and use the cross-head screwdriver to tighten the M4x12 screws.

2

Connect the cables.

Figure 9-9 Remove and replace the loading sensor No.

Name

1

M4x12

cross

FRU code

No.

Name

FRU code

M04-051152---

2

Sensor

011-000021-00

panhead screw When servicing the autoloader, if you remove the sample feeding platform, the front supporting board needs to be re-adjusted. For detailed instruction, see 5.2.1 Autoloader, Figure 5-29 Front -back, left-right position adjustment for front supporting board assembly.

9-13

FRU Replacement and Debugging

9.4 Replacing the Tube Stabilizing Assembly FRU 9.4.1 Removing and Replacing the Compressing Spring Piece and Spring 

Tools

Inner hexagon spanner 

Procedures

Remove the compressing spring piece: 1

Use an inner hexagon spanner to unscrew the M3x5 screw on the compressing spring piece and the rotary plate, and take down the compressing spring piece and finger pressure block at the same time;

2

Use the inner hexagon spanner to unscrew the M3x5 screw on the compressing spring piece and the finger pressure block, and separate the compressing spring piece from the finger pressure block.

Remove the pinch roller spring: Press the pinch roller spring tightly with a hand so that the spring is detached from the locating pin, and then take out the pinch roller spring. Install the compressing spring piece: 1

Use the inner hexagon spanner and one M3x5 screw to lock the compressing spring piece;

2

Use the inner hexagon spanner and one M3x5 screw to lock the compressing spring piece on the rotary plate;

Install the pinch roller spring: Manually insert one end of the pinch roller spring into the corresponding hole on the roller fixing plate, and press the other end of the spring to insert the spring into the locating pin.

9-14

FRU Replacement and Debugging

Figure 9-10 Remove the compressing spring piece and spring No.

Name

1

Inner

hexagon

FRU code

No.

Name

FRU code

M04-051095---

4

Rotary plate

041-024204-00

033-000675-00

5

Roller fixing plate

041-024203-00

041-026679-00

6

Pinch roller spring

033-000624-00

screw M3x5 2

Compressing spring piece

3

Finger

pressure

block 

Validation

1

Check whether the compressing spring piece can act normally;

2

Check whether the pinch roller spring is fixed in the hole and dowel.

9-15

FRU Replacement and Debugging

9.5 Introduction to Rotatory Scanning Component

Figure 9-11 Roller No.

Name

FRU code

No.

1

Motor

009-000446-00

7

Name Support

FRU code bracket

screen) 2

Inner

hexagon

m04-051110

8

Bearing fixing plate

041-005170-00

9

Vertical

screw M3x6 3

Mindray

syringe

coupler 4

Inner

plate

assembly hexagon

m04-051096

10

screw M3x8

Combination screw M3x8

5

Roller

041-023832-00

6

Roller sleeve

049-001272-00

11

9-16

Motor fixing plate-2

(silk 042-020561-00 041-023830-00 042-019147-00 030-000099-00 041-023829-00

FRU Replacement and Debugging

9.5.1 Removing and Replacing the Motor and Roller Sleeve 

Tools

Inner hexagon spanner 

Procedures

Remove the motor: 1

Remove the cables connected to the motor;

2

Use the inner hexagon spanner to loosen the two M3x8 screws of the self-made syringe coupler, unscrew the four M3x6 screws fixing the motor, and take out the motor;

Remove the roller sleeve: Manually take the roller sleeve from the roller Install the motor: 1

Insert the motor axis into the hole of Mindray syringe coupler, tighten the 4 M3x6 screws fixing the motor, and then tighten the 2 M3x8 screws fixing the Mindray syringe coupler;

2

Connect the motor cable.

Install the roller sleeve: 1

Manually install the roller sleeve into the roller.

Figure 9-12 Remove the motor and roller sleeve No.

Name

FRU code

No.

Name

1

Motor

009-000446-00

4

Inner

9-17

FRU code hexagon

m04-051096

FRU Replacement and Debugging

screw M3x8 2

Inner hexagon screw

m04-051110

5

Roller

M3x6 3

Mindray coupler

041-02383200

syringe

041-00517000

6

Roller sleeve

049-00127200



Validation

1

Make sure the motor works properly.

2

Make sure the roller sleeve is inside the roller.

9-18

FRU Replacement and Debugging

9.6 Introduction to Pincher Roller Assembly

Figure 9-13 Pinch roller assembly No.

Name

FRU code

No.

Name

1

Motor fixing plate-1

042-020562-00

8

Linear guide rail set

(silkscreen) 2

Stepping motor

024-000863-00

9

Guide shaft

3

Small pulley 1

BA30-21-

10

Pinch roller spring

11

Pinch roller drive

06582 4

Synchronous

031-000164-00

toothed belt

plate

FRU code 032-000083-00 041-023825-00 033-000624-00 042-018382-00

5

Synchronous pulley

M6C-010002--

12

Front sensor barrier

042-018383-00

6

Pinch roller

041-023828-00

13

Sensor

011-000021

7

Drive plate

042-018503-00

14

Rear sensor barrier

042-018384-00

9-19

FRU Replacement and Debugging

9.6.1 Removing and Replacing the Motor, Sensors and Pinch Roller Spring 

Tools

107 Phillips screwdriver Nipper pliers Inner hexagon spanner Tension measuring device 

Procedures

Remove the motor: 1

Remove the cables connected to the motor;

2

Use a Phillips screwdriver to unscrew the 4 M3x8 screws fixing the motor, and incline the motor axis inwards to take out the motor.

Remove the sensor: 1

Remove the cables connected to the sensor;

2

Use a Phillips screwdriver to unscrew the M4x12 screw fixing the sensor.

Remove the pinch roller spring: 1

Use a pair of nipper pliers to remove the split washer;

2

Push the guide shaft to the back of the assembly, and take out the spring.

Install the motor: 1

Insert the motor axis, install the synchronous belt, adjust the synchronous belt tension, and adjust the belt width to 6.4 mm to tighten the belt. Use four M3x8 inner hexagon screws to fix the motor. The wiring direction of the motor is shown in the figure.

2

Connect the motor cable.

Install the sensor: 1

Use the Phillips screwdriver to fix the sensor with one M4x12 screw;

2

Connect the sensor wire.

Install the pinch roller spring: 1

Set the spring into the guide shaft, and push the guide shaft to the front of the assembly;

2

Use the nipper pliers to fix the split washer on the guide shaft.

9-20

FRU Replacement and Debugging

Figure 9-14 Remove the motor, sensors and pinch roller spring No.

Name

FRU code

No.

Name

FRU code

1

Stepping motor

024-000863-00

5

Split washer

m04-021055

2

Combination screw

m04-051140

6

Pinch roller spring

M3x8

033-000624-00

3

Drive plate

042-018503-00

7

Sensor

011-000021

4

Guide shaft

041-023825-00

8

Screw M4x12

m04-051001



Validation

1

Check whether the motor can operate normally;

2

Check whether the spring can operate normally;

3

Check whether the sensors are installed at a proper position.

9-21

FRU Replacement and Debugging

9.7 Introduction

to

Sampling

Assembly

and

Replacement Procedure

Figure 9-15 Sampling assembly No.

Name

FRU code

No.

1

Sensor

011-000021-00

7

Name Probe

FRU code wipe

sampling) 2 2

Motor

position

(closed041-023727-00

2800-21-28878

8

Inner hexagon screw M3x6 M04-051110---

sensor assembly 3

Screw M3x6

M04-002505---

9

Piercing probe

4

Sensor

011-000021-00

10

Sample probe fixing plate

5

Screw M4x12

M04-051152---

11

6

Motor

024-000366-00

Motor

115-033912-00 042-019940-00 024-000366-00

9.7.1 Removing and Replacing Detection Sensor 

Tools

107 Phillips screwdriver 

Procedures

1

Before removing the sensor 1 and sensor 6, unplug the sensor connector, use a Phillips screwdriver to unscrew screws 2 and 5, replace the sensor, and then connect the sensor connector;

2

Before removing the sensor 3, unplug the sensor connector, use a Phillips screwdriver to unscrew two screws 4, replace the sensor, and then connect the sensor connector;

9-22

FRU Replacement and Debugging

Figure 9-16 Removing and replacing detection sensor No.

Name

1

Sensor

2 3

FRU code

No.

Name

FRU code

011-000021-00

4

Screw M3x6

M04-002505---

Screw M4x12

M04-051152---

5

Screw M4x12

M04-051152---

Motor

2800-21-28878

6

Sensor

011-000021-00

position

sensor assembly

9.7.2 Removing and Replacing Probe Wipe (Closed-Sampling) and Sampling Probe 

Tools

Cross-headed screwdriver Inner hexagon spanner 

Procedures

1

Before removing the probe wipe (closed-sampling), unplug the rubber hose fixed on the probe wipe (closed-sampling). Use an inner hexagon spanner to unscrew two screws 3, replace the probe wipe (closed-sampling), and then fix the rubber hose onto the probe wipe (closed-sampling); pay attention to the probe wipe (closed-sampling) installation direction.

2

Before removing the sample probe, first remove the probe wipe (closed-sampling) (step 1 in section 4.2.3), move the puncture slider to the top, unscrew the two screws 7 fixing the sample probe fixing plate, take down the sample probe fixing plate, and replace the sample probe; then assemble the parts in the reverse order. Pay attention to the sample probe 9-23

FRU Replacement and Debugging

installation direction when replacing the sample probe.

Figure 9-17 Removing and replacing the sample probe and probe wipe (closedsampling) No.

Name

1

Probe

wipe

FRU code

No.

Name

FRU code

041-023727-00

5

Puncture slider

041-026248-00

041-026247-00

6

Sample

042-019940-00

(closed-sampling) 2 2

Z

direction

support bracket 3

Screw M3x6

fixing plate M04-051110---

7

Combination screw M3x8

4

Piercing probe

probe

115-033912-00

9-24

030-000099-00

FRU Replacement and Debugging

9.7.3 Removing and Replacing Y Direction Motor and Z Direction Motor 

Tools

Cross-headed screwdriver Inner hexagon spanner Tension measuring device 

Procedures

Removing the Y direction motor Before removing the Y direction motor, use an inner hexagon spanner to unscrew the four M3x8 screws fixing the motor, incline the motor axis inwards to take out the motor together with the synchronous pulley, and then unscrew the two lock screws on the synchronous pulley; Installing the Y direction motor Install the new motor, the synchronous pulley and two lock screws, with one lock screw locked on the motor flat position, insert the motor axis, install the synchronous belt, adjust the synchronous belt tension, and adjust the belt width to 6.4 mm to tighten the belt. Use four M3x8 inner hexagon screws to fix the motor. The wiring direction of the motor is shown in the figure.

Figure 9-18 Removing and Replacing the Y direction motor

9-25

FRU Replacement and Debugging

No. 1

Name Y

direction

FRU code

No.

Name

FRU code

042-019935-00

4

Lock screw M3x5

M04-051102---

024-000366-00

5

Inner

M04-051096---

bracket 2

Motor

hexagon

screw M3x8 3

Small pulley 1

BA30-21-06582

6

Synchronous belt

031-000484-00

Remove the Z direction motor; 1

Loosen the two lock screws (No. 1) at the left end of the guide rail, unscrew the screw (No. 6) at the right end of the guide rail, draw out the guide rail (No. 2), and remove the Z direction support bracket shaft sleeve (No. 5);

2

Unscrew the three screws (No. 4) on the front protective board (silk screen) (No. 3), and take down the front protective board (silk screen) (No. 3); unscrew the two screws (No.12) fixed on the rotation stop block (No. 10);

3

Unscrew the two screws (No. 8) fixing the synchronous belt (No. 7) and synchronous belt clamp (No. 9), and take down the Z direction support bracket (No. 5) and the parts fixed on it;

4

Loosen the two lock screws (No. 15) fixed on the motor axis, unscrew the four screws (No. 13) fixing the motor, and take out the motor (No. 14) to be replaced.

Install the Z direction motor; 1

Insert the new motor into the corresponding hole (No. 11) on lead screw, use four screws (No. 13) to fix the motor, and then use two lock screws (No. 15) to fix the motor axis (one lock screw is installed on the flat position of motor axis); the motor outlet direction is shown in the figure;

2

Insert the guide rail (No. 2) into the Z direction support shaft sleeve (No. 5), use two lock screws (No. 1) to fix the left end of guide rail and use the screw (No. 6) to fix the right end of guide rail;

3

Use two screws (No. 12) to fix the rotation stop block (No. 10) onto the Z direction support bracket (No. 5);

4

Use three screws (No. 4) to fix the front protective board (silk screen) (No. 3);

5

Use two screws (No. 8) to fix the synchronous belt clamp (No. 9) and synchronous belt (No. 7) onto the Z direction support (No. 5).

9-26

FRU Replacement and Debugging

Figure 9-19 Removing and Replacing the Y direction motor No. 1

Name

FRU code

Guide rail front

No.

Name

FRU code 3100-20-40868

041-026246-00

9

Belt clamp

032-000594-00

10

Rotation

fixation block 2

Precision shaft

stop

043-002307-00

block 3

Front

protective

board

(silk

042-019964-00

11

Lead screw

041-007088-00

M04-051140---

12

Self-tapping

M04-000305---

screen) 4

Combination screw M3x8

5

Z

direction

screw PT3x12 041-026247-00

13

support bracket 6

Inner

hexagon

Inner

hexagon

M04-051026---

screw M3x10 M04-051101---

14

Motor

024-000366-00

15

Lock screw M3x5

M04-051102---

screw M4x8 7

Synchronous belt

031-000484-00

8

Inner

M04-051110---

hexagon

screw M3x6 

Validation

1

Check whether the motor can operate normally;

2

Check whether the Z direction support operates normally.

9-27

FRU Replacement and Debugging

9.8 Introduction to mix assembly

Figure 9-20 mix assembly diagram No. 1 2

Name

FRU code

Z direction support

042-015965-

bracket

00

No.

Z direction moving

Name

5

Tube pincher

6

Y direction motor

assembly 3 4

FRU code 115-035779-00 024-00015000

Y direction moving

M04-002505-

assembly

--

R direction motor

024-000150-

7

Z direction motor

024-00036600

00

9-28

FRU Replacement and Debugging

9.8.1 Removing and Replacing Detection Sensor 

Tools

107 Phillips screwdriver 

Procedures

1

When removing sensor 1, 2, 3 and 4, use a Phillips screwdriver to unscrew the corresponding fixing screw (pan head screw M3x5) (No.5), replace the sensor, and then lock the screw;

2

When removing sensor 7, use a Phillips screwdriver to unscrew the corresponding fixing screw (pan head screw M4x12) (No.6), replace the sensor, and then lock the screw;

Figure 9-21 Removing and replacing detection sensor

9-29

FRU Replacement and Debugging

No. 1

Name Motor

FRU code

No.

Motor

2800-21-28878

5

Pan head screw M3x5 M04-051031---

position

2800-21-28878

6

Pan head screw M4x12 M04-051001---

position

2800-21-28878

7

Sensor

position

2800-21-28878

sensor 3

Motor sensor

4

Motor

FRU code

position

sensor 2

Name

011-000021-00

sensor

9.8.2 Removing and Replacing Motor 

Tools

Inner hexagon spanner Tension measuring device 

Procedures

Removing the Z direction motor Before removing the Z direction motor, use an inner hexagon spanner to unscrew the four M3x8 screws fixing the motor, incline the motor axis inwards to take out the motor together with the synchronous pulley, and then unscrew the two lock screws on the synchronous pulley; Install the Z direction motor: Install the new motor, the synchronous pulley and two lock screws, with one lock screw locked on the motor flat position, insert the motor axis, install the synchronous belt, adjust the synchronous belt tension, and adjust the belt width to 6.4 mm to tighten the belt. Use four M3x8 inner hexagon screws to fix the motor.

Figure 9-22 Remove and replace the Z direction motor 9-30

FRU Replacement and Debugging

No.

Name

1

Z

FRU code direction

042-015965-00

No. 4

support bracket 2

Motor

3

Inner

hexagon

Name

FRU code

Synchronous

031-000451-00

pulley 024-000366-00

5

Lock screw M3x5

M04-051102---

M04-051096---

6

Synchronous belt

031-000452-00

screw M3x8 Removing the Y direction motor Use an inner hexagon spanner to unscrew the four M3x8 screws fixing the motor, incline the motor axis inwards to take out the motor together with the synchronous pulley, and then unscrew the two lock screws on the synchronous pulley; Install the Y direction motor: Install the new motor, the synchronous pulley and two lock screws, with one lock screw locked on the motor flat position, insert the motor axis, install the synchronous belt, adjust the synchronous belt tension, and adjust the belt width to 6.4 mm to tighten the belt. Use four M3x8 inner hexagon screws to fix the motor.

Figure 9-23 Removing and Replacing the Y direction motor

9-31

FRU Replacement and Debugging

No.

Name

FRU code

No.

Name

1

Synchronous belt

BA30-10-06618

4

Inner

FRU code hexagon

M04-051096---

screw M3x8 2

Small pulley 1

BA30-21-06582

5

Motor fixing plate

042-017479-00

3

Lock screw M3x5

M04-051102---

6

Motor

024-000150-00

Removing the R direction motor Use an inner hexagon spanner to unscrew the three M3x8 screws fixing the motor, incline the motor axis inwards to take out the motor together with the synchronous pulley, and then unscrew the two lock screws on the synchronous pulley; Install the R direction motor: Install the new motor, the synchronous pulley and two lock screws, with one lock screw locked on the motor flat position, insert the motor axis, install the synchronous belt, adjust the synchronous belt tension, and adjust the belt width to 6.4 mm to tighten the belt. Use three M3x8 inner hexagon screws to fix the motor.

Figure 9-24 Remove and replace the R direction motor No.

Name

FRU code

No.

Name

1

Synchronous belt

BA30-10-06618

4

Inner

FRU code hexagon

M04-051096---

screw M3x8 2

Small pulley 1

BA30-21-06582

5

Motor fixing plate

042-017479-00

3

Lock screw M3x5

M04-051102---

6

Motor

024-000150-00

9-32

FRU Replacement and Debugging

9.9 Gain Adjustment 

Purpose:

To set the gain to make the instrument operate in a specified status. Adjustment method: 1

Use the user service level account and password to log in, tap "Settings"  "Gain Settings" in the menu to enter the "Gain Settings" screen shown below.

Figure 9-25 Gain adjustment screen 2

The gain value can be adjusted only when the edit box is activated. If the gain setting is beyond the valid range or is set to be blank, the system will prompt that the input is invalid and restore the set gain value to the result before editing.

3

After setting, tap another button, the software displays the dialog box below. Tap "Yes" to save settings and switch the screen; tap "No" to switch the screen directly without saving the settings.

Figure 9-26 Dialog for confirming saving 9-33

FRU Replacement and Debugging

Note: As shown in the figure, confirm that the WBC bath is filled with reagent, the HGB lamp is on and naked eyes cannot see bubbles on the inner wall of cistern on the light path. If bubbles are found, see "Common Faults and Troubleshooting" to handle the problem. Enter the currently new voltage value on the screen shown in the figure so that the HGB background voltage is in the range of 4.5±0.2V, and then tap "Save".

Figure 9-27 WBC bath and HGB assembly (right side)

9-34

FRU Replacement and Debugging

9.10 Installing and Adjusting Rotary Scanning Device 

Purpose

To upgrade the instrument from tube detection to rotary scanning detection. Installation method (for the mechanical structure, see Section 5.2.2 ): 1. Rotary scanning fixing mechanism and rotary scanner installation and wiring

Install

the

rotary scanning fixing mechanism

Install

the

scanner

Figure 9-28

Figure 9-29 Install the rotary scanner and fixing mechanism as shown in Figure 9-30 and Figure 9-31, lead the wire through the inside of the machine and out of the threading hole at the lower part of the 9-35

FRU Replacement and Debugging

autoloader board, and connect it to the motor and sensor of the fixing mechanism (fixing mechanism connection cable 009-007303-00: connect the J17 socket on the autoloader board and the sensor connector on 009-006866-00).

CAN communication cable 1 8130

CAN communication cable 2 8131

J11 Autoloader board power cable 6762

J10 P1

J20

Scanner patching line 7671

Autoloader board 6k2 051-002829-00

J2 Valve board power supply and control extension cable 8127

J19

J6

J9

J7

J8

J17

Compression mechanism Autoloader Autoloader connection photocoupler sensor cable ext ension cable extension cable 7303 8125 6866

J16

J15

J14

Autoloader motor extension cable 6867

Figure 9-30

Samplin g plate

Fixing mechanism sensor connector

Figure 9-31 2. Install the roller mechanism on the autoloader board Place the auto-loading feeding channel assembling fixture (898-000201-00) as shown in the figure, making it closely pressed to the floating blood ring seat.

9-36

FRU Replacement and Debugging

1. Remove the rubber.

3. Push the assembly closely connected to the fixture and then tighten the two screws here.

2. First tighten the two screws here.

Figure 9-32

6. Small cable tie 5. Install the rubber ring 6. Cables connected to motor

6. Small cable clip 4. Loosen these two screws so that the edge of the assembly gets completely pressed to the arc edge of fixture

Figure 9-33 (1) Remove the rubber part of roller on the roller assembly, as shown in Figure 9-32; (2) Use the stainless steel cross pan head screw assembly M4x8 (torsion moment: 4~6 kgf.cm) to fix the roller assembly on the table board; (3) First push the roller assembly to the left, keep the component close to the fixture according to the arrow direction in Figure 9-33, and tighten the M3x8 cross pan head screw on it (torsion moment: 4~6kgf.cm); (4) Loosen the M4x8 screw in 2), push the roller assembly to the left to make the trolley completely pressed to the arc edge of fixture, and then tighten the screw (torsion moment: 4~6 kgf.cm). The screw must be tightened here, as shown in Figure 9-33; (5) Take down the fixture, and install the removed rubber ring; (6) Connect the reserved wire to the motor, and use the small cable clip and small cable tie to 9-37

FRU Replacement and Debugging

fix the cables, as shown in Figure 9-33. 3. Adjusting the rotary scanning fixing mechanism position and confirming its function 1

Tap "Settings" → "System Settings" → Barcode", select the appropriate code system and number of barcode digits used on the customer's site, exit and save the settings;

2

Place the rotary scanning fixing mechanism adjusting fixture (898-000303-00) into the tube rack, and place this tube rack on the autoloader; on the software screen, tap "Service" → "Debug&Self-test" → "Self-test" tap the "Autoloading Assembly" button, and then tap "Loading" → "Feeding" in turn. Move the fixture until it arrives below the compressing module (as shown in Figure 9-34 and Figure 9-35);

Figure 9-34

Figure 9-35 3

Manually pull out the rotary scanning fixing mechanism, and check whether the fixture is in the center of the compressing structure. Also check whether the tube rack moves to the 9-38

FRU Replacement and Debugging

left or right. If yes, feed the tube rack again from the initial position; 4

If there is any position deviation, loosen the screws fixing the rotary scanning assembly, adjust its position in the horizontal position, and fix it till the fixture falls into the center of the compacting structure;

5

Tap "Tube Detect", place a tube rack with five tubes in the loading area, tap "Start", and make sure that the instrument can correctly detect if there is a tube or not.

4. Adjusting the scanner position and confirming functions 1

Place the tube with a barcode on the tube rack, with the barcode facing the opening on the tube rack. Load and feed the tube rack to the scanning position, and tap "Scanner On" to check if the scanner can be turned on normally. Loosen the locking screw of the scanner as shown in Figure 9-35, adjust the scanner position and make sure that the scanner can scan the tube barcode. Tap the "Scanner Off" button. Note: The scanner blinks quickly when it correctly scans the barcode, but it is steady on when no barcode is scanned.

2

Tap the "Auto-Read Barcode" button to read the tube barcode. The barcode content will be displayed in the barcode content column. Make sure that the read barcode content is correct and the recognition rate is 100%.

Scanner locking screw

Figure 9-36

9-39

Chapter 10 Maintenance 10.1 Recommended Maintenance Frequency Daily

Program When the instrument works for 24 hours continuously without shutdown, perform "Probe Cleanser Soak" every day. Before running any samples, run the Controls to ensure reliable results of the analyzer. For the specific quality control analysis operation methods, see Chapter 8 "Quality Control" in the user manual.

Every week

Perform "Probe Cleanser Soak" every week as long as it works.

Half-year

Clean and maintain the count baths, including the scraps and crystals on the shielding box, and crystals on the bath surface, etc. Clean the baths with distilled water; as using other cleaning agent may leave crystals on the baths.

As needed

When the count baths may be contaminated, perform count cleaning procedures (on the software, tap "Menu-Service-Maintenance-Cleaning"; When the analyzer frequently reports that liquid sticks to the volume metering tube, check whether the air filter is covered with dust. If yes, replace the air filter. When the piercing count exceeds 100000, replace the sample probe to ensure accuracy of tests. If the analyzer will be idle for a long time (more than 2 weeks), the packup function needs to be implemented. If any other error is reported, follow the troubleshooting information on the software or in the Operator's Manual to remove it.

10-1

Maintenance

10.2 Active Maintenance 10.2.1 Pre-maintenance Preparations Tools Table 10-1 Tool List No.

Tool Names

Quantity

1

Cross-head screwdriver

1

2

Slot-headed screwdriver

1

3

M2.5 Allen wrench

1

4

Diagonal pliers

1

5

Tweezers

1

6

Blade

1

Notes

Consumables Table 10-2 Consumables List No.

Tool Names

Quantity

Notes

1

Gloves

Several

2

Tissues

1 roll

3

Medium cable tie

4

Cotton swab

1

5

Cleaning cloth

3

6

Lubricating grease

1

7

Probe Cleanser

1

8

5ml syringe

1

9

Low-level QC

1

For verifying instrument performance

10

Normal-level QC

1

For verifying instrument performance

Several

and test repeatability 11

High-level control

1

For verifying instrument performance

12

Calibrator

1

For calibrating the instrument (if needed)

10.2.2 Maintenance Plan and Content Maintenance package [3206 one year maintenance package (FRU)] Material ID 041-006857-00

Material Name Block ring

Instructions For replacement; for details see the maintenance guide.

10-2

Maintenance

115-011660-00

Probe wipe filter

115-011660-00

Waste filter

115-010567-00

Sheath fluid filter

M6G-020011---

Pinch valve tube

0010-10-12408

Diluent filter

For replacement; for details see the maintenance guide. For replacement; for details see the maintenance guide. For replacement; for details see the maintenance guide. For replacement; for details see the maintenance guide. For replacement; for details see the maintenance guide.

10-3

Maintenance

Maintenance plan and content Hospital Name:

Dpt.:

Frequency

Person in charge: Program

Analyzer model: 2 years

3 years

4 years

5 years

6 years

7 years

/60000

/120000

/180000

/240000

/300000

/360000

/420000

samples

samples

samples

samples

samples

samples

samples

Check the buffer bath Check tube pincher Replace the blocking ring (if needed) Check the drive pulley, driven pulley and slide rail Check the tube detection sensor status Verify the sample probe position in the reaction bath

samples maintenance

Telephone:

1 year

Check the waste cistern floater

1 year/60000

Serial number:

Check the HGB and optical reaction bath bubble mixing tube Check tube of reagent cap assembly Clean the crystal on the solenoid valve Clean the crystal on the syringe Maintain the pinch valve tube Clean the piercing probe, probe wipe and probe wipe barrier Replace the diluent filter Check piercing probe abrasion status Clean the HGB bath RBC bath and optical reaction bath Lubricate the moving parts

10-4

Maintenance

Check and replace the wearing parts Perform Probe Cleanser maintenance to the waste cistern Check the instrument status

Check the instrument according to the state checklist.

Confirm the

Confirm that the instrument performance,

general

status and graph are all normal, and

performance of

perform

the instrument

procedures as needed)

Data Backup and Export

debugging

and

calibration

Back up the database and export the sample records

Note: 1） Wear gloves during the cleaning, and wash hands with the cleanser or the disinfectant after the cleaning. 2） Probe cleanser is a kind of strong corrosive detergent. Be careful not to let it spill to your skin or clothes. If it spills to your skin or clothes, clean with plenty of water immediately or it may hurt your skin or damage your clothes. Detailed steps of active maintenance Inspection Item

Maintenance

Note

Tools and

Notes

Consumables Check the waste cistern floater

 Check WC1/WC2

the cistern

floaters  Check the waste container floater

1） Open the left door of the instrument;

Probe Cleanser

Caution:

2） Check the WC1 and WC2 cistern floaters, and observe if there is much dirt on the floater (no need

Syringe

Shut down the analyzer first before you clean

to clear the dirt at this stage. You will need to clean

floater

the dirt after servicing the waste cistern);

container.

Otherwise

when

instrument

3） If a waste container is used, take out the waste container cap assembly, and check whether there

in the

enters

the

the

waste

standby

are dirt on the waste cistern floater; if yes, soak the

status, waste fluid may

floater with Probe Cleanser for more than 10 minutes

spray out.

10-5

Maintenance

No.

Name

1 2

Inspection Item

FRU code

No.

Name

WC2 cistern floater

3

WC1 cistern floater

Buffer bath

4

Waste container floater

Maintenance

Note

FRU code

Tools and Consumables

Check the buffer bath

 Check the crystal and liquid in the buffer bath

1） Open the left door of the instrument; 2） Check the status of buffer bath besides WC2. If there are a lot of crystals or liquid in the buffer bath, If there is much crystal or liquid inside, check if there is liquid flowing back, or if there is any other problem to be dealt with.

10-6

Cross-headed screwdriver

Notes

Maintenance

Check tube pincher

 Check tube pincher

Cross-headed

1） Open the front cover of the instrument. 2） Check whether the tube gripper is deformed or

screwdriver

bent; or cannot grip the tube firmly

No.

Name

1

Tube gripper

FRU code

No.

10-7

Name

FRU code

Maintenance

Inspection Item

Maintenance

Note

Tools and

Notes

Consumables Replace

the

blocking

ring (if needed)

Replace the blocking ring (if

[Check whether the blocking ring is scratched or

Cross-headed

needed)

worn. If yes, check the piercing probe for bending.

screwdriver

If yes, correct it in time, and replace the blocking ring. After replacement, push the blocking ring to four limit positions (the four corners) to avoid interference with the piercing probe and blocking ring.]

Check the tube rotatory scanning mechanism (Applicable

Cross-headed screwdriver

the

which compress the tubes and see whether

Tube racks

configured

they can rotate smoothly; if the pulleys are

Lubricating oil

with barcode scanning

rusted by liquid and cannot move, use

assembly only)

lubricating oil to lubricate the inside of driven

instrument

to

Check the drive pulley, driven 1） Open the front cover of the instrument; pulley and slide rail 2） Use hands to rotate the two driven pulleys

pulleys and make sure that they can move easily. After service, clean the lubricating oil on the outer ring of driven pulleys, otherwise the barcode may get soiled; 3） Use a hand to drag forward and backward the support fixing the driven pulley, and feel if the linear slide rail can move smoothly; if you feel obvious friction, the slide rail may be rusted, and you need to use lubricating oil to lubricate

10-8

Limit position

Maintenance

it; 4） Tap

--- to enter the autoloading assembly self-test screen. Tap to load the tube rack to the scanning position. Tap and check if the tube can be steadily rotated; if not, finely tune the drive pulley position to the direction of main unit Check

the

tube

detection sensor status (Applicable

to

instrument

Check the tube detection sensor status

1） Make sure that there are no tube racks on the load tray;

the

2） Tap  

not

, select the [Tube Detection

configured

with

a

Sensor] tab. Tap , and observe the

barcode

scanning

blank voltage change rate. If the change rate

assembly only)

is greater than 1.1 or smaller than 0.9, tap , and then tap .

Check

the

tube

detection sensor status (Applicable

to

instrument

the

Check the tube detection sensor status

1） Make sure that there are no tube racks on the load tray

not

2） Tap   , select the [Tube Detection

configured

with

a

Sensor] tab. Tap , and observe the

barcode

scanning

blank voltage change rate. If the change rate

assembly only)

is greater than 1.1 or smaller than 0.9, tap , and then tap .

10-9

Maintenance

Inspection Item

Maintenance

Note

Tools and Consumables

Verify the sample probe

Verify

the

sample

probe

position in the reaction

position in the reaction bath

bath

[Procedure: Select "Service" → "Debug&Self-test" → "Adj. Sample Probe Pos. ", and tap WNB bath pos., DIFF bath pos. and RET bath pos. (if configured with the RET module) respectively, and check the probe position in each bath. For the DIFF/RET bath, the probe shall fall in the centre of the bath; but for the WNB bath, the probe should be about 2.5mm from the center of the bath.

Check the HGB and optical

reaction

bubble mixing tube

bath

 Check the HGB and optical reaction bath bubble mixing tube

instrument; 2） Take off the HGB bath shield cover;

 Check the HGB and optical reaction bath bubble mixing and

1） Open the front cover and right plate of the

liquid

function

discharging

3） Check the bubble mixing tube which is connected to one channel of the 3-way connector under the HGB bath. The interior Teflon tube shall exceed the three-way connector for 4 mm. 4） Perform the measurement, and check if the bubble mixing in the HGB bath works OK, and the waste is discharged smoothly. 5） Follow the same procedure to check the optical reaction bath.

10-10

Cross-headed screwdriver

Notes

Maintenance

No.

Name

1

HGB bath shield

Inspection Item

FRU code

No. 2

Maintenance

Name

FRU code

Three-way pipe

Note

Tools and Consumables

Check tube of reagent

Check tube of reagent cap

cap assembly

assembly

1） Check and make sure the lyse and diluent tubes connected to the back plate of the analyzer are not bent nor leaking air. 2） Organize the tubes, and make sure they are not pressed or bent. 3） Check and make sure the fluorescent reagent tubes are properly connected.

10-11

/

Notes

Maintenance

No.

Name

1

Lyse and diluent connection

FRU code

No. 2

tubes

10-12

Name Dye connection tubes

FRU code

Maintenance

Inspection Item

Maintenance

Note

Tools and

Notes

Consumables Clean the crystal on the

Check for the crystal on the

solenoid valve

electromagnetic valve

1） Open the left and right doors and front cover of the instrument;

Cross-headed

2） Check for the crystal status on the Mindray valves in the fluidic system and clean the

Cleaning cloth

screwdriver

crystal Clean the crystal on the syringe

Clean the crystal on the syringe

1） Open the left and right doors and front cover of the instrument;

Cleaning cloth

Caution: 1) Clean the parts when

2） Check for the crystallization status at the bottom of the plungers of the 10ml syringe,

the crystallization is not

250ul syringe and 100ul syringe; in case of

large amount of crystal,

liquid

directly

leakage,

replace

the

syringe

assembly; if crystal is found, use a clean cloth to wipe it clean; 3） After cleaning, run several samples and check the syringe, making sure there is no liquid leakage.

10-13

serious. When there is

parts.

replace

the

Maintenance

No. 1 2

Name

FRU code

10ml syringe 250ul syringe

10-14

No.

Name

3

100ul syringe

FRU code

Maintenance

Inspection Item

Maintenance

Note

Tools and

Notes

Consumables Maintain the pinch valve

Check and maintain the pinch

1)

Open the left and right doors of the instrument;

Cross-headed

tube

valve tube

2)

Release the pressure of the pressure chamber;

screwdriver

3)

Check the silica gel pinch valve tubes connected to valves PV01-PV07; make sure that the tubes are all OK, with no leakage or damage. If the tubes are all OK, adjust the pinching position as required. (Note the PV05 and PV06 are wearing parts, and need to be replaced regularly)

No.

Name

1

PV01/02/03/04/07

2

PV05

FRU code

10-15

No.

Name

3

PV06

FRU code

Maintenance

Inspection Item

Maintenance

Note

Tools and Consumables

Clean

the

piercing

probe, probe wipe and probe wipe barrier

 Clean

the

outer

wall

of

piercing probe  Clean the upper and lower end faces of probe wipe  Clean the probe wipe barrier

1） Disconnect the diluent and waste tubes to the probe wipe;

Cross-head

2） Unscrew the screw on the upper surface of the probe wipe and take down the probe wipe;

Tweezers

3） Drop some drops of Probe Cleanser on the

Probe Cleanser

bloodstain at the upper and lower end faces of probe wipe, and soak the bloodstain for about 3 minutes; 4） Use clean water to clean the probe wipe; 5） Use a piece of cleaning cloth dipped with Probe Cleanser to wipe the exterior wall of the sample probe. Soak the exterior wall of the sample probe for about 3 minutes, then clean the sample probe exterior wall with clean water. 6） Put the probe wipe back on the rack and connect the tube; 7） Dip a cotton swab into Probe Cleanser, and use the cotton swab to wipe the upper and lower end faces and inner ring of probe wipe barrier, Soak the probe wipe barrier for about 3 minutes, and then clean it wall with clean water. Note There are probe wipe barriers at both autoloading piercing position and at the closed-sampling piercing position (for closed-sampling type analyzers/open-sampling position (for the opensampling type analyzers)

10-16

screwdriver Cleaning cloth Cotton swab

Notes

Maintenance

8） After

the

above

cleaning

operation,

run

background tests for 3 to 5 times, and make sure that the probe cleanser attached to the probe wipe and sampling probe is cleaned;

10-17

Maintenance

No.

Name

FRU code

No.

Name

FRU code

1

Diluent tube

3001-10-07069

4

Probe wipe

041-023727-00

2

Waste tube

M90-100071---

5

Piercing probe

115-033912-00

3

Screw

6

Probe wipe barrier

Inspection Item

Maintenance

Note

Tools and

Notes

Consumables Replace the diluent filter

Replace the diluent filter

[Steps: 1. Remove the old filter (be careful when

/

handling the residue liquid in the tube, and make sure it is not sprayed to other positions). 2. Install a new filter (pay attention to the installation direction: the filter

Flow direction

has the Filter mark on it, and the liquid is supposed to flow in the direction from letter "F" to letter "r")] Check piercing probe

Check for the piercing probe

Power off the instrument, use a hand to push the

abrasion status

abrasion status

piercing probe out of the probe wipe, and check the wear condition of the outer wall of piercing probe; if the wear condition is found severe, replace the piercing probe

Clean the covers of the

Clean the crystals and dust on

HGB bath, RBC bath

the covers of the HGB bath,

and optical reaction bath

RBC bath and optical reaction bath

1) 2)

Use a cross-head screwdriver to open the right

Cross-head

door of the instrument;

screwdriver

Use a cotton swab dipped with water or alcohol

Cotton swab

to wipe the HGB bath cover, RBC bath cover and upper part of optical reaction bath

10-18

Maintenance

No.

Name

1

HGB bath cover

2

Optical reaction bath

Inspection Item

FRU code

Maintenance

No.

Name

3

RBC bath cover

Note

FRU code

Tools and Consumables

Lubricate parts

the moving

Check and lubricate the moving

1)

parts

Check the movements of the loading unit,

Cross-headed

feeding unit and unloading unit during sample

screwdriver

autoloading process. Use a small amount of

Lubricating

grease to lubricate guide rail and wheel shaft. 2)

Check movements of the sample compartment assembly and the piercing assembly, and take 10-19

grease

Notes

Maintenance

a small amount of grease to lubricate the guide rail and wheel shaft. 3)

Check for the motion of syringe assembly and lubricate linear motor lead screw.

Check and replace the

Check and replace the wearing

Check and replace the wearing parts by referring to

wearing parts

parts

the content in the replacement list of wearing parts. For details, see below table.

Table 10-3 List of wearing parts No. 1 2

Name Piercing probe and probe wipe Pinch valve tubes to PV05 and PV06 (pharmed pinch valve tubes)

FRU code

Position In the sample probe assembly on the middle baffle

Service Life 100,000 times

Left side of the instrument, on the back plate

60,000 times/1 year

3

Probe wipe filter

Left side of the instrument, on the back plate

60,000 times/1 year

4

Waste filter

Left side of the instrument, on the back plate

60,000 times/1 year

5

Sheath fluid filter

On the upper part of the left plate of the analyzer

45,000 times/1 year

6

Air pump

On the right plate of the analyzer

2000H

10-20

Notes Piercing times

Maintenance

No.

Name

1 2

No.

Name

Waste filter

3

Sheath fluid filter

Probe wipe filter

4

Air pump

Inspection Item

FRU code

Maintenance

Note

FRU code

Tools and Consumables

Perform Probe Cleanser

Perform

maintenance

maintenance to WC1 and WC2.

to

the

Probe

Cleanser

1）

Log in with a service account, and tap "Service"-"Maintenance"-"Fluidics"-"WC

waste cistern

Cistern Time-based Maintenance".

Follow

the software instruction and pour a whole bottle of Probe Cleanser into WC2. 2）

Add diluent to the WC2 cistern till the cistern is full;

3）

Remove a pipe connected to the WC1 cistern cover, and add diluent to the cistern till the

10-21

Syringe Probe Cleanser Tweezers

Notes

Maintenance

cistern is full; 4）

Leave the instrument alone for 40 minutes. The

instrument

cleaning.

10-22

automatically

performs

Maintenance

10.2.3 Check the Instrument Status Check the overall instrument status. Conduct the check according to the following table in every visit. Inspection Item

Description

Reference

Result

Notes

120KPa

110~125 kPa

□Pass

□Fail

/

90KPa

90±5 kPa

□Pass

□Fail

/

Analyzer pressure

50KPa

500±5 kPa

□Pass

□Fail

/

status

-30KPa

-30±5 kPa

□Pass

□Fail

/

-40kPa

-40±5 kPa

□Pass

□Fail

/

Fluid pressure

50~120 kPa

□Pass

□Fail

/

Optical system

31~38 °C

□Pass

□Fail

/

SPMT

31~38 °C

□Pass

□Fail

/

40~43 °C

□Pass

□Fail

/

RET reaction bath

40~43 °C

□Pass

□Fail

/

Preheating bath

29~34 °C

□Pass

□Fail

/

RBC diluent

12~36 °C

□Pass

□Fail

/

Instrument

12~36 °C

□Pass

□Fail

/

CPU temperature

0~100 °C

□Pass

□Fail

/

HGB blank

3.20~4.80V

□Pass

□Fail

Adjustable

2.10~2.60V

□Pass

□Fail

Adjustable

Whether they are

Not bent or

□Pass

□Fail

/

bent, damaged or

damaged, free

□Pass

□Fail

/

□Pass

□Fail

/

□Pass

□Fail

/

temperature WBC reaction bath

Analyzer temperature

temperature HGB blank voltage

voltage value Sensor Level

Fluorescent

Settings

reagent detect sensor

Power network

cord, cable,

reagent tubes

having

of bubbles

inside No

Waste tube

bubbles

crystal

and

No crystal and

blockage in the

blockage

tube Air whether

leakage, the

No air leakage, the

diluent floater

diluent

sensor

sensor

Reagent container

floater

moves

moves

tube cap assembly

smoothly,

and

smoothly, and

whether

the

the

Barcode scanner

sensor

sensor connectors

connectors do

get loose

not get loose

Whether

the

The scanning is

scanning

is

normal and the 10-23

Maintenance

normal

and the

operation

is

operation

is

standard

standard

10.2.4 Confirm the General Performance of the Instrument Run the controls of high, normal and low values on the instrument, and check if the QC results are in control. If not, calibrate the instrument. Do the background and repeatability tests to confirm that the instrument performance, status and graph are all normal. If not, perform necessary debugging and calibration (if needed) Inspection Item

Description

Reference

WBC

≤ 0.1  10 / L

□Pass

□Fail

WBC-D

9

≤ 0.2  10 / L

□Pass

□Fail

12

□Pass

□Fail

12

Background and

RBC

blank counting requirements-

test requirements-

≤ 0.02 10 / L

Result

RBC-O

≤ 0.02 10 / L

□Pass

□Fail

HGB

≤ 1 g/L

□Pass

□Fail

PLT

≤ 5  10 /L

□Pass

□Fail

PLT-O

≤ 5  10 /L

□Pass

□Fail

9

≤ 0.001 10 /L

□Pass

□Fail

≤ 0.003 10 /L

□Pass

□Fail

1000 ~ 6000

□Pass

□Fail

□Pass

□Fail

□Pass

□Fail

blood

Background/blank

Value

9

9 9

WBC-BF/ TC-BF RBC-BF

12

body fluid Standard particle

Total

number

of

particles WNB FS center of gravity DIFF FS center of gravity

480.0~615.0 480.0~615.0

WNB FS CV

≤ 2.5%

□Pass

□Fail

DIFF FS CV

≤ 3.2%

□Pass

□Fail

□Pass

□Fail

DIFF SS center of gravity

998.0~1350.0

DIFF SS CV

≤ 19.0%

□Pass

□Fail

WNB SS CV

≤ 19.0%

□Pass

□Fail

/

□Pass

□Fail

/

□Pass

□Fail

/

□Pass

□Fail

□Pass

□Fail

WNB channel

Graph are normal and in proper position

Fresh blood

DIFF Channel

Graph are

samples

normal and in

scattergram

proper position RET Channel

Graph are normal and in proper position

Repeatability -

WBC

≤ 2.5%

10-24

Notes

Maintenance

whole blood

RBC

≤ 1.5%

□Pass

□Fail

HGB

≤ 1.0% very

□Pass

□Fail

poor ≤ 3

Repeatability -

MCV

≤ 1.0%

□Pass

□Fail

HCT

≤ 1.5%

□Pass

□Fail

PLT

≤ 4.0%

□Pass

□Fail

□Pass

□Fail

□Pass

□Fail

WBC-BF/ TC-BF

≤ 30%

body fluid RBC-BF

≤ 40% or range ≤ 7000/μL

10.2.5 Data Backup and Export 

Be sure to export the client sample size data after active maintenance is completed. Requirements:



Export one-year's data to the maintenance date.



Upload the exported sample statistics to the CRM system.



You can use the following methods to export data:



Use a USB drive to export data:

Note to insert the USB drive first. 1

Enter the "Status" - "Statistics" screen. Tap the "Summary" button.

2

Tap “Export”.



Scan the 2D QR code to export data

It is recommended to use the QR Reader+ APP (For the iOS system, search and download the APP in the Apple Store; for the Android system, search and download it using the web browser) to your mobile phone for QR code scan. 1

Enter the "Status" - "Statistics" screen. Tap the "QR code" button.

10-25

Maintenance

The software generates a QR code. 2

Open the QR Reader+ APP and scan the QR code.

The following information displays.

10-26

Maintenance

a b

MATMSG

The email must be sent to: [email protected]; you cannont

To

change the email address

SUB

The subject of the email message, in the format of XXXXXXXXX-YYYYMM-DD (XXXXXXXXX indicating the analyzer serial number, YYYY-MM-DD indicating the export date.

c

Body

Main body of the message; manually enter the Country, City, Hospital information

d 3

Body

The coded data

Tap “Send email” on the APP to enter the “send email message” interface.

10-27

Maintenance

4

Enter necessary information such as “Country”, “City” and “Hospital”, and send the message to [email protected].

The encrypted message can be decrypted by ConvertDataTool. When using other QR code scan apps other than QR Reader+ APP, you may need to open your own mailbox, create a new message, manually copy the encrypted information to the message, and send it to [email protected].

10-28

Maintenance

10.3 Standard Operation Procedures of QC and Calibration 10.3.1 Quality Control Quality Control (QC) consists of strategies and procedures that measure the precision and stability of the analyzer. The results imply the reliability of the sample results. QC involves measuring materials with known, stable characteristics at frequent intervals. Analysis of the results with statistical methods allows the inference that sample results are reliable. Mindray recommends you run the QC program daily with normal level controls. A new lot of controls should be analyzed in parallel with the current lot prior to their expiration dates. This may be accomplished by running the new lot of controls for five days using any empty QC files. The QC files Calculate the mean, standard deviation and coefficient of variation for each selected parameter. The instrument calculated means of these ten runs should be within the expected ranges published by the manufacturer. For the quality control requirements and methods, see the Chapter "Using the QC Program" in the Operator's Manual.

10.3.2 Calibration Calibration is a procedure to standardize the analyzer by determining its deviation under certain specified conditions. In order to get accurate sample analysis results, calibrate the analyzer when necessary. For the calibration requirements and methods, refer to "Calibrating Your Analyzer" in the Operator's Manual.

10.3.3 Mixing Methods of Mindray Self-made Quality Controls and Calibrator Storage requirements The controls and calibrators should be stored in a refrigerator at about 2~8°C. Before use 1

Always check for the validity of the reagents before use. Never use a reagent that is beyond its expiry date. After taking the reagent out from the refrigerator, keep it still for at least 15 minutes at room temperature before mixing.

2

Record the open-vial date on the vial label for every newly opened vial of control/calibrator, so you can track whether the reagent has passed its open-vial validity.

Mixing method After keep the control/calibrator for 15 minutes at room temperature, follow below instruction to 10-29

Maintenance

mix it. Follow the time requirements in each step when mixing the reagent. And for each single vial of reagent, the whole mixing procedure should last for at least 5 minutes. 1

Keep the vial cap upward, and use two hands to rub it slowly and repeatedly for 1.5 to 2 minutes.

Figure 10-1 Keep the vial cap upward 2

Keep the vial cap downward, and use two hands to rub slowly and repeatedly for 1.5 to 2 minutes.

Figure 10-2 Keep the vial cap downward 3

Place the vial flat (parallel to the ground) between your hands, and rub slowly and repeatedly for 1.5~2 minutes.

Figure 10-3 Vial parallel to the ground 4

Keep the reagent vial upside down after mixing and check the vial bottom. It should meet the requirements shown in Figure 10-4. If not, continue to mix it, till it reaches the standard.

10-30

Maintenance

Poor mixing: the bottom of the vial is still covered by reagent residue, and there is no obvious transparent ring belt.

Good mixing: there should be no large and opaque black residues at the bottom of the vial; and there is a transparent reagentfree residue belt.

Figure 10-4 Comparison of good and poor mixing effects 5

Each time after running the control/calibrator, cap the vial as soon as possible to reduce the contact between the reagent and the air. Otherwise the reagent will get volatilized and resulting in inaccurate results.

6

When the mixing procedure is completely, before each test cycle, shake the vial gently.

7

If during or after a set of tests (including calibration tests and repeatability tests), the reagent has been kept for still for more than 5 minutes, if you are use it again, follow the instruction in step 4 to check for its status. Use it only when it meets the requirements. Otherwise mix it again.

Note Always place the controls and calibrators back to the refrigerator after work (either at noon, afternoon, or night). Before next use, the reagent should be kept in the refrigerator for at least 1 hour. During tests, never leave the reagent uncapped when it is not used. Otherwise the reagent will get volatilized and resulting in concentration change and inaccurate results. After the mixing procedure, do not mix the vials violently during tests. Excessive mixing also may result in inaccurate test results. Gently shake the control/calibrator for each test cycle. The open-vial validity for controls is 14 days at 2~8°C in a refrigerator, and the open-vial validity for calibrators is 7 days at 2~8°C in a refrigerator. Do not use the controls/calibrators which pass the validity period.

10-31

Chapter 11 Troubleshooting Information 11.1 Introduction At present, the fault prompt in the 6000 series instruments is mainly found in two places, as shown in Figure 11-1: the Message prompt area on the right of the screen, including the WBC Message, RBC Message and PLT Message; the fault alarm area at the lower part of the screen, which aims to distinguish the sample problems and instrument faults.

Message area

Error area

Figure 11-1 Fault display areas The Message area displays three types of messages: insufficient suction, plugging and HGB channel exception. The insufficient suction message is displayed in the WBC Message area, and the plugging and HGB channel exception messages are displayed in the RBC Message area. There are two main faults sources in the Message area: the test results identified by the algorithm are abnormal, the user needs to be prompted, and the warning message will be given in the Message area; an exception is found through signal detection, e.g., the sample suction pressure curve is found faulty during sample suction, and possibly a clot in the blood sample blocks the sample suction needle, which is not a fault of the instrument, so it is displayed in the Message area. The fault area is used to display the fault of the instrument such as the pressure, temperature fault and reagent depletion, which requires the user to perform some operations or the service personnel to provide on-site repair service. The fault area displays the alarm faults. When you tap the fault area, the fault code, fault summary and fault details (fault details can only be viewed 11-1

Troubleshooting Information

by the operator with the user service permission or above) will be displayed. The fault can be handled or repair can be conducted accordingly so long as the fault generation conditions and possible causes are clear. The fault display mode in the fault area is shown in Figure 11-2.

Error code Error summary

Error details

Figure 11-2 Fault codes and detailed breakdown information

11-2

Troubleshooting Information

11.2 Message Area Codes 11.2.1 Reagent Type Detection principle The reagent detection principle is the same for lyse and diluent. As shown in Figure 11-3, when the reagent flows in the detection tube, the sensor detects whether there is reagent in the detection tube by optical signals. When there is no reagent or bubbles pass through the detection tube, the detection sensor will detect the change of signal and send an alarm. The availability detection principle of fluorescent dye liquor detection is similar to that of lyse. The difference is that no lyse tube is used in fluorescent dye liquor detection, and the detection sensor detects the dye liquor pipe directly. Detection sensor

Tubing

Detection tube

Reagent container

Figure 11-3 Principle of reagent detection Errors for reagents consist of no reagent error, reagent insufficient error, and reagents need to be replaced or primed after being reloaded, and reagents expired error. Error codes and error report mechanism 

No reagent alarm Table 11-1 No reagent error messages Error ID

Error message

0x32060010

No DS reagent

0x32060011

No LD Lyse

0x32060012

No LH Lyse

0x32060013

No LN Lyse

0x32060014

No DR Diluent

0x32060015

No FN Dye

Error report mechanism

Reagent detection board detects bubbles or no reagent in DS diluent detection tube.

The sensor of the corresponding channel cannot

11-3

Troubleshooting Information

0x32060016

No FD Dye

detect dye liquor in the pipe or detects that bubbles

0x32060017

No FR reagent

flow through the pipe.

When the instrument reports no reagent error, check the corresponding reagent container or bag and see if there is really no reagent. When there is still reagent (the very little reagent left at the bottom of the container/bag which cannot be aspirated does not count), directly tap "Remove Error". If there is no reagent, install a new reagent container/bag, and reload the reagent by scanning the barcode information. If the error cannot be removed, possible causes include: the corresponding reagent tube leaks (air leakage will lead to air bubbles in the tube), the reagent tube connector is broken, the detection tube is not connected properly to the reagent detection, cables to the reagent detection board is not connected reliably, and the reagent detection board is damaged. The difference between the "no reagent" error and the "insufficient reagent" is, when a no reagent error is reported, the software-calculated reagent volume is usually not deducted to zero. Therefore when no reagent errors are reported, directly tap "Remove Error" to remove the errors (no need to reload the reagent by scanning barcode information). 

Reagent expired errors Table 11-2 Reagent expired error messages Error ID

Error message

0x32060020

DS Diluent expired

0x32060021

LD Lyse expired

0x32060022

LH Lyse expired

0x32060023

LN Lyse expired

0x32060024

DR Diluent expired

0x32060025

FN Dye expired

0x32060026

FD Dye expired

0x32060027

FR Dye expired

Error report mechanism

The reagent validity countdown starts at user registering the reagent information to the analyzer by scanning the reagent barcode. The analyzer reports error when a reagent passes its open-vial validity period or the expiry date.

When the analyzer reports the reagent expired errors, even the reagent is not actually used up, to remove the error, new barcode information needs to be registered, of a reagent that is the same type and is never used on the instrument. 

Insufficient reagent Table 11-3 Insufficient reagent errors Error ID

Error message

Error report mechanism

0x32060030

DS Diluent low volume

When a reagent is newly registered, the

0x32060031

LD Lyse low volume

software refreshes the reagent initial volume,

0x32060032

LH Lyse low volume

and each time a sequence is run, the software

0x32060033

LN Lyse low volume

reducts the corresponding consumption. When

0x32060034

DR Diluent low volume

the total consumption reaches the threshold, 11-4

Troubleshooting Information

0x32060035

FN Dye low volume

0x32060036

FD Dye low volume

0x32060037

FR Dye low volume

the analyzer reports error.

Insufficient reagent errors are reported when the software calculated reagent residue volume is deducted to zero. To remove the error, new barcode information needs to be registered, of a reagent that is the same type and is never used on the instrument. 

Reagent has not been replaced error Table 11-4 Reagent has not been replaced error messages Error ID 0x32060040

Error message

Error report mechanism

DS Diluent has not been replaced

0x32060041

LD Lyse has not been replaced

0x32060042

LH Lyse has not been replaced

0x32060043

LN Lyse has not been replaced

0x32060044

DR Diluent has not been replaced

0x32060045

FN Dye has not

The error is reported when the customer registers a new and valid reagent on the software. Tap "Remove Error" and the analyzer will automatically replace the reagents in the instrument and removes the error.

been replaced 0x32060046

FD Dye has not been replaced

0x32060047

FR Dye has not been replaced

The error is reported when the customer registers a new and valid reagent on the software. Tap "Remove Error" and the analyzer will automatically replace the reagents in the instrument and removes the error. 

Reagent not primed errors Table 11-5 Reagent not primed error messages Error ID 0x32060050

Error message DS

reagent

not

primed 0x32060051

LD LH primed

The error is reported when a certain reagent passes its expiry date, and the customer registers

Lyse

not

primed 0x32060052

Error report mechanism

a new and valid reagent on the software.

Tap

"Remove Error" and the analyzer will automatically Lyse

not

prime the instrument with the reagent and removes the error. 11-5

Troubleshooting Information

0x32060053

LN

Lyse

not

Diluent

not

primed 0x32060054

DR

primed 0x32060055

FN Dye not primed

0x32060056

FD Dye not primed

0x32060057

FR Dye not primed

The error is reported when a certain reagent passes its expiry date, and the customer registers a new and valid reagent on the software.

Tap "Remove Error" and the analyzer will

automatically prime the instrument with the reagent and removes the error. Different between reagent priming and reagent replacing: when priming the instrument with the reagents, the expired reagent in the cisterns and tubes will be completely discharged first, and then the new reagent will be absorbed from the new reagent container/bag; while when replacing the reagent, the old reagent in the cisterns and tubes will not be discharged; the instrument directly absorbs the reagent from the reagent container/bag to fill the cisterns or tubes.

11.2.2 Waste-Related Errors Detection principle The waste error is detected by the floater sensor. When the floater ball is at the lower position, the sensor is at "on" position; and when the floater ball is at the upper position, the sensor is at "off" position. The system thus determines the liquid level in the waste container by the sensor status.

Floater rod

Floater ball

Waste container

Figure 11-4 Waste liquid level detection principle

11-6

Troubleshooting Information

Error codes and error report mechanism Table 11-6 Waste container full error Error ID

Error message

Error report mechanism When the waste in the waste container has

0x32060001

Waste

container

full

reached a certain level, the floater ball floater upward, and the sensor status changes and triggers error report.

To remove the waste container error, empty the waste container first, and then tap "Remove Error" on the software. To avoid false report of this error, install the waste container in a carton box, and use a supporting board to lock the mouth of the container and prevent the container from collapsing (when the container collapses, the analyzer will report the error even when the waste is not half the container). When the waste container full error cannot be removed, check for the following possible causes: the floater ball or rod get stuck; the BNC connector at the back of the instrument are not properly connected; and the floater is damaged. When the instrument is set to direct discharge of waste, the error will not be reported. Select Menu  Settings  Auxiliary Settings  Other Settings, and check if the "Enable waste direct discharge" is enabled. When the customer is using waste containers, make sure the option is not checked. Otherwise even if the BNC connector is properly connected, the analyzer will not monitor waste level, or give any alarm...

Figure 11-5 Enable direct discharge of waste 11-7

Troubleshooting Information

11.2.3 Floater-Related Errors Detection principle Floater sensors are also used in the reagent cisterns, waste cisterns and air cell. The working principle is the same as for the waste cistern. Error codes and error report mechanism Table 11-7 Float error messages Error ID 0x32060070 0x32060071

Error message DIL

floater

Error report mechanism

status

abnormal FCM

floater

status

At the time points that the time sequence

abnormal

judges a certain cistern is about to full, the

0x32060072

LD floater status abnormal

system inquiries if the floater ball in that

0x32060073

LH floater status abnormal

cistern is at the upper position. If not, the

0x32060074

LN floater status abnormal

analyzer reports error.

0x32060076 0x32060076

0x32060077

0x32060078

DR

floater

status

abnormal WC1

floater

status

abnormal WC2

At the time points that the time sequence judges WC1/WC2 has been emptied, the

floater

status

abnormal

system inquiries if the floater ball in that cistern is at the lower position. If not, the analyzer reports error.

-40kPa air cell floater

Theoretically, the floater balls in -40kPa and

status abnormal

90kPa air cells should always be at their lower position. The software inquires the air cell floater status every second. When it detects the floater ball are not the lower

0x32060079

90kPa

air

cell

status abnormal

floater

position for 5 consecutive times, the analyzer reports error. When the floater in an air cells is not at lower position, it indicates there is liquid flowing back to the chambers.

Usually the reagent cistern floater errors can be removed by tapping "Remove Error". If the error cannot be removed, check whether there is reagent in the corresponding reagent container, whether the reagent tube is pressed or folded; or if the outlet tube of cistern leaks liquid. When all the above factors are excluded, check whether the floater sensor is damaged. Usually the WC1/WC2 floater errors can be removed by tapping "Remove Error". If the error cannot be removed, check whether the waste discharge tube get clogged, whether a tube is pressed or folded; or whether the floater ball and the rod are stuck together. When all the above 11-8

Troubleshooting Information

factors are excluded, check whether the floater sensor is damaged. For the -40kPa and 90kPa air cell floater errors, check whether there is any liquid in the air cell. If there is liquid, manually clear the liquid, and then tap "remove Error". If there is no liquid in the air cell but the error cannot be removed, check whether the air cell floater sensor line is connected reliably to the floater connector (if the floater is not connected to sensor, the instrument will report the floater status abnormal of the air cell). When all the above factors are excluded, check whether the floater sensor is damaged. Select "Menu"  "Status"  "Floater Status" to check the floater status in each baths, waste cisterns and waste container and that in the air cells. While "Empty" means that the floater ball is at the lower position, and "Full" means that the floating ball is at the upper position. Tap on the screen to test all floaters except for the floaters of the -40kPa air cell, 90 kPa air cell and the waste container. Use this function when it is absolutely necessary, as the procedure will consume reagents, and will take approximately 30 minutes.

Figure 11-6 Floater status screen

11.2.4 Syringe Type Detection principle There are 3 types of syringes, namely ASP syringe (100uL), SP syringe (250uL) and DIL syringe (10mL). Each syringe consists of one motor and one home position sensor. The system determines whether the syringe operates normally by monitoring the syringe aspiration amount, discharge amount, action time as well as the sensor status. Every time a syringe resets, the software starts to record and accumulate the aspiration amount 11-9

Troubleshooting Information

and from which, it deducts the dispensed liquid amount. For example, if the syringe performs three aspiration actions (aspirated amount being a1, a2 and a3 respectively), and two dispensed actions (dispensed amount being b1 and b2 respectively). Then, the amount of residual liquid in the syringe is v = a1+a2+a3-b1-b2. Firstly, v cannot be a negative value; otherwise the software will report "xx syringe dispensed volume too high", meaning that the total dispensed volume has exceeded the total aspirated volume, which is not acceptable. Secondly, v cannot exceed the maximum capacity of syringe; otherwise the software will report "xx syringe aspirated volume too high". Error codes and error report mechanism As long as the instrument has undergone the normal startup procedure (startup initialization is not skipped), the errors of "Conflicting XX syringe action", "XX syringe dispensed volume too high", "XX syringe aspirated volume too high" or "XX syringe action time out" are rarely reported. When any of these errors are reported, it often indicates time sequence errors or bugs. Syringe errors usually can be removed by tapping the "Remove Error" button. If the errors cannot be removed or after you remove the errors, they still frequently occur, check the following items: 1)

Check whether the cables connecting the motor and sensor of the corresponding syringe assembly are reliably connected; and whether there are liquid splashing or corrosion;

2)

Check whether the wiring to the motor and sensor is broken;

3)

Check whether the motor drive chip on the drive board is damaged;

4)

Check whether the rotating screw and the motor shaft gets slipping;

5)

Check whether the syringe plunger is bent and deformed.



ASP syringe (100 uL) errors

For users at administrator or common user level, all the following errors are displayed in the form of "ASP syringe action abnormal". Table 11-8 ASP syringe (100 uL) error messages Error ID

Error message

Error report mechanism This alarm will be triggered when the

0x32060131

Conflicting

ASP

syringe

actions

syringe is not initialized or is in the process of an action, while a new command is received.

0x32060132

0x32060133

0x32060134

Error

occurs

when

ASP

syringe leaves sensor area ASP syringe failed to return to home position ASP

The motor cannot drive the sensor blade to leave the sensor area home position during syringe initialization The motor cannot drive the sensor blade to the sensor area home position during syringe initialization

aspiration/dispensation

action failure 1

After

the

syringe

aspiration/dispensation

performs action,

the sensor

blade still blocks the home position sensor 11-10

Troubleshooting Information

while it should have already left the sensor detection area home position. After 0x32060135

ASP

aspiration/dispensation

action failure 2

the

syringe

aspiration/dispensation

performs action,

the sensor

blade dose not block the sensor while it should have returned to the sensor detection area. Before

ASP 0x32060136

syringe

aspiration/dispensation action not allowed 1

syringe

aspiration/dispensation

performs action,

system

detects that the sensor is blocked, but based on the system recorded syringe motor steps, the sensor should not be blocked. Before

ASP 0x32060137

syringe

syringe

aspiration/dispensation

performs action,

system

aspiration/dispensation action

detects that the sensor is not blocked, but

not allowed 2

based on the system recorded syringe motor steps, the sensor should be blocked. Before the syringe action, the software detects the total residue liquid volume after

0x32060138

ASP syringe aspirated volume too high

the

aspiration

action

exceeds

the

maximum capacity set for the syringe. This fault should not occur at the client site. If it occurs, it is the most likely a time sequence design problem. The actual action time used by the syringe is greater than the set time of time

0x32060139

ASP syringe action time out

sequence. This fault should not occur at the client. If it occurs, it is the most likely a time sequence design problem. Before the syringe action, the software detects the total residue liquid volume after

0x32060140

ASP syringe aspirated volume

the aspiration action is a negative value.

too high

This fault should not occur at the client site. If it occurs, it is the most likely a time sequence design problem.



SP syringe (250uL) alarm

For users at administrator or common user level, all the following errors are displayed in the form of "SP syringe action abnormal".

11-11

Troubleshooting Information

Table 11-9 SP syringe (250uL) error messages Error ID

Error message

Error report mechanism This alarm will be triggered when the

0x32060151

syringe is not initialized or is in the process

SP syringe action conflict

of an action, while a new command is received.

0x32060152

0x32060153

SP syringe failed to leave the initial position

The motor cannot drive the sensor blade to leave the sensor area home position during syringe initialization

SP syringe failed to return to the initial position

The motor cannot drive the sensor blade to the sensor area home position during syringe initialization After

0x32060154

SP syringe suction action failure 1

the

syringe

aspiration/dispensation

performs action,

the sensor

blade still blocks the home position sensor while it should have already left the sensor detection area home position. After

0x32060155

SP syringe suction action failure 2

the

syringe

aspiration/dispensation

performs action,

the sensor

blade dose not block the sensor while it should have returned to the sensor detection area. Before

SP 0x32060156

syringe

aspiration/dispensation action not allowed (1)

syringe

aspiration/dispensation

performs action,

system

detects that the sensor is blocked, but based on the system recorded syringe motor steps, the sensor should not be blocked. Before

SP 0x32060157

syringe

syringe

aspiration/dispensation

performs action,

system

aspiration/dispensation action

detects that the sensor is not blocked, but

not allowed (2)

based on the system recorded syringe motor steps, the sensor should be blocked. Before the syringe action, the software detects the total residue liquid volume after

0x32060158

SP syringe aspirated volume too high

the

aspiration

action

exceeds

the

maximum capacity set for the syringe. This fault should not occur at the client site. If it occurs, it is the most likely a time sequence design problem. The actual action time used by the syringe

0x32060159

SP syringe action time out

is greater than the set time of time sequence. This fault should not occur at the 11-12

Troubleshooting Information

client. If it occurs, it is the most likely a time sequence design problem. Before the syringe action, the software detects the total residue liquid volume after 0x32060160

SP syringe dispensed volume

the aspiration action is a negative value.

too high

This fault should not occur at the client site. If it occurs, it is the most likely a time sequence design problem.



DIL syringe (10 mL) alarm

For users at administrator or common user level, all the following errors are displayed in the form of "DIL syringe action abnormal". Table 11-10 DIL syringe (10 mL) error messages Error ID

Error message

Error report mechanism This alarm will be triggered when the

0x32060111

syringe is not initialized or is in the process

DIL syringe action conflict

of an action, while a new command is received. The motor cannot drive the sensor blade to

0x32060112

Conflicting DIL syringe actions

leave the sensor area home position during syringe initialization

0x32060113

DIL syringe failed to return to the initial position

The motor cannot drive the sensor blade to the sensor area home position during syringe initialization After

0x32060114

DIL

aspiration/dispensation

action failure 1

the

syringe

aspiration/dispensation

performs action,

the sensor

blade still blocks the home position sensor while it should have already left the sensor detection area home position. After

0x32060115

DIL

aspiration/dispensation

action failure 2

the

syringe

aspiration/dispensation

performs action,

the sensor

blade dose not block the sensor while it should have returned to the sensor detection area. Before

DIL 0x32060116

syringe

aspiration/dispensation action not allowed 1

syringe

aspiration/dispensation

performs action,

system

detects that the sensor is blocked, but based on the system recorded syringe motor steps, the sensor should not be blocked.

0x32060117

DIL

syringe

aspiration/dispensation action 11-13

Before

syringe

aspiration/dispensation

performs action,

system

Troubleshooting Information

not allowed 2

detects that the sensor is not blocked, but based on the system recorded syringe motor steps, the sensor should be blocked. Before the syringe action, the software detects the total residue liquid volume after

0x32060118

DIL syringe aspirated volume too high

the

aspiration

action

exceeds

the

maximum capacity set for the syringe. This fault should not occur at the client site. If it occurs, it is the most likely a time sequence design problem. The actual action time used by the syringe is greater than the set time of time

0x32060119

DIL syringe action time out

sequence. This fault should not occur at the client. If it occurs, it is the most likely a time sequence design problem. Before the syringe action, the software detects the total residue liquid volume after

0x32060120

DIL syringe dispensed volume

the aspiration action is a negative value.

too high

This fault should not occur at the client site. If it occurs, it is the most likely a time sequence design problem.

11.2.5 Sampling Assembly-related Errors Detection principle The sampling assembly enables the sample probe to move in both horizontal and vertical directions. The sampling assembly has a motor and a home position sensor in the vertical direction (Z-axis direction), and a motor, a home position sensor and a position verification sensor in the horizontal direction (Y-axis direction). The system determines whether the action is normal by the sampling assembly location, moving distance and sensor status. Error codes and error report mechanism As long as the instrument has undergone the normal startup procedure (startup initialization is not skipped), the errors of "Conflicting command to sampling assembly", "XX syringe dispensed volume too high", "Sampling assembly actions in horizontal direction time out" or "Sampling assembly actions in vertical direction time out" are rarely reported. When any of these errors are reported, it often indicates time sequence errors or bugs If the system reports "Sampling assembly failed to return to home position in vertical direction", "Sampling assembly failed to leave home position in vertical direction", "Sampling assembly failed to leave home position in horizontal direction" or "Sampling assembly failed to return to home position in horizontal direction", note to check whether the corresponding motor (in vertical or horizontal directions) makes a sound of being blocked. If not, check as follows: 1） Check whether the connectors of the motor cable and the patching cords are reliably 11-14

Troubleshooting Information

connected, and if the connector and transfer line connector are connected reliably, and if liquid splashing or corrosion at the connectors; 2） Check whether the motor cables are broken or damaged; 3） Check whether the drive on the drive board is damaged If the corresponding vertical motor or horizontal motor makes a sound of being blocked, in addition to the above procedures, also follow below instructions: 1） Find the position where the mechanism gets stuck, e.g., whether the screw gets loose and is too long, and if it hooks on or hits the rubber hose; 2） Check whether the connectors of the home position sensor and the patching cords are reliably connected, and if the connector and transfer line connector are connected reliably, and if liquid splashing or corrosion at the connectors; 3） Check whether the corresponding home position sensor cable is broken or damaged. When the system reports "Sampling assembly confirmation sensors in horizontal direction abnormally blocked" or "Sampling assembly notch count jumps in horizontal direction abnormal", check the following: 1） Whether the sample probe hooks on or hits the rubber hose during horizontal movement. 2） Whether the top and bottom surfaces of the sampling assembly horizontal position verification sensor are too close to the notched sheet metal; 3） Whether the connectors of the sensor and the patching cords are reliably connected, and if the sensor connector and transfer line connector are connected reliably, and if liquid splashing or corrosion at the connectors; 4） Whether the sensor cable is broken or damaged. If the system reports "Sample probe pierce action loses steps", check whether the probe tip making a small hole on the floating blood barrier at the piercing position of the autoloader. If not, the lock screw between the vertical motor rotation shaft and lead screw of sampling assembly gets loose; if there is a small hole on the blood barrier, operate as follows: 1） Check whether the bottom plate of autoloader is closely attached to the bottom plate of main unit; 2） Check whether the sample probe is bent; if yes, replace the sample probe first; 3） Remove the old floating blood barrier, tap -- to enter the sample probe adjustment screen. Select . Tap "Horizontal Pos." and then "Vertical Pos." under the "Position Observe" area, and check the sample probe position. When the sample probe is not aligned with the center of the tube position in the horizontal direction, tap "To Adjusted Pos." to adjust the sample probe position. 4） Install a new floating blood barrier, adjust the blocking plate of the floating blood barrier to the top position, and then adjust the floating blood barrier to the most front position and most back position respectively, tap on the sample probe adjustment screen  AL aspiration position, and observe whether the probe tip will pierce the floating blood barrier.

11-15

Troubleshooting Information

For users at administrator or common user level, all the following errors are displayed in the form of "Sampling assembly action abnormal". Table 11-11 Sampling assembly error messages Error ID 0x32060201

Error message

Error report mechanism

Sampling assembly failed to

The motor in the vertical direction cannot

return to home position in

drive the sensor blade to the sensor area

vertical direction

home position.

Sampling assembly failed to 0x32060202

return to home position in vertical direction

0x32060203

0x32060204

drive the sensor blade to leave the sensor area

home

during

sampling

assembly initialization The motor in the horizontal direction cannot

return to home position in

drive the sensor blade to the sensor area

horizontal direction

home position in horizontal direction.

Sampling assembly failed to

The motor in the horizontal direction cannot

return to home position in

drive the sensor blade to leave the sensor

horizontal direction

area home position in horizontal direction. assembly

confirmation

sensors

horizontal

in

direction

abnormally blocked

After the

horizontal motor

completed,

Sampling count

assembly

the

sampling

action

is

assembly

confirmation sensor in horizontal direction is not at the gap position or not blocked. After the

0x32060206

position

Sampling assembly failed to

Sampling 0x32060205

The motor in the vertical direction cannot

horizontal motor

action

is

notch

completed, the number of notches detected

jumps in horizontal

by the sampling assembly confirmation

direction abnormal

sensor

in

horizontal

direction

is

inconsistent with expectation. When the vertical motor is returning to the 0x32060207

Sample probe pierce action loses steps

upper position, the system detects that the sensor barrier triggers the home position sensor in the vertical direction at an earlier time than expected. When the vertical motor is returning to the upper position, the system detects that the sensor barrier triggers the home position sensor in the vertical direction at a later time than expected

0x32060208

Sample probe lifting action loses steps

Usually the error won't be reported at the client site. If it is reported, possible causes include: ① The sample probe pierces in the not-forpuncturing area (e.g., the plastic area) of 11-16

Troubleshooting Information

tube, causing the sample probe becoming bent. ② the lock screw between the vertical motor rotation shaft and lead screw of sampling assembly gets loose. This alarm will be triggered when the 0x32060209

Conflicting

command

to

sampling assembly

sampling assembly is not initialized or is in the process of an action, while a new command is received. The actually consumed time of sampling assembly horizontal movement is greater

0x32060210

Sampling assembly horizontal

than the set time of time sequence. This

action time out

fault should not occur at the client site. If it occurs more frequently, it is the most likely a time sequence design problem. The actually consumed time of sampling assembly vertical movement is greater

0x32060211

Sampling assembly vertical

than the set time of time sequence. This

action time out

fault should not occur at the client site. If it occurs more frequently, it is the most likely a time sequence design problem. Before

horizontal

movement

of

the

sampling assembly, the system detects that the home position sensor in the vertical Vertical home position sensor 0x32060212

not blocked before sampling assembly

horizontal

movement

direction is not blocked. An alarm is reported as this may lead to bending of the sample probe. Usually the client does not report this fault. If it is reported, check if the connector of vertical home position sensor is connected, leaks liquid or gets corroded, and if the sensor wire is broken or damaged.

11.2.6 Mix Assembly-Related Type Detection principle The mix assembly mixes the samples upside down. The sampling assembly has a motor and a home position sensor in the vertical direction (Z-axis direction), and a motor, 2 sensors in the horizontal direction (Y-axis direction), and a motor and a sensor in the rotatory direction (R direction). The system determines whether the action is normal by the mix assembly location, moving distance and sensor status. For the Y direction sensor, the one close to the back plate of instrument is the home position sensor (or front sensor), and the end position sensor (or rear sensor) is near the front cover. 11-17

Troubleshooting Information

The lower position sensor is Z direction is the home position sensor and the upper position sensor is the end position sensor. Error codes and error report mechanism The most possible causes for mix assembly errors: 

The tube gripper position in front-to-back or left-to-right directions become offset

A possible cause of this is that the autoloader is not installed closed to the main unit during installation, or the tube gripper position is not adjusted after the mix assembly is replaced, which makes the tube drops easily or causes the mix assembly to report error. 

Liquid corrosion

As the mix assembly is located near the sampling assembly and the flow cell is right above it, once there is a damaged tube, or any tubes are not properly inserted, leaked liquid easily enters the mix assembly. If fluid infiltrates into the motor rotation shaft, it will inevitably cause the motor rotation shaft to rust. If the liquid enters the motor or the sensor cable connector, it will cause short circuit or corrosion of the connector; if the liquid enters the Y direction home position or end position sensor, the sensor will be damaged, and need to be replaced. If the liquid is sprinkled on the sensor detection surface, crystal will be formed on the sensor detection surface, and the sensor detection capability will be affected. In this case, use a cotton swab dipped in alcohol to clean the sensor detection surface. 

Interference

When other objects (such as tubes) interfere with the mix assembly in its movement area, the system often will report error. When the cable tie of the sampling assembly faces the right of the instrument, the sampling assembly easily interferes with the mix assembly too. 

Cable or core wires get damaged

Although the wire harness in the mix assembly uses swing resisting design, but if the harness is not bound or fixed correctly, the harness or the core wires may get broken. For users at administrator or common user level, all the following errors are displayed in the form of "Mix assembly action abnormal". Table 11-12 Mix assembly error messages Error ID

Error message

Error report mechanism This alarm will be triggered when the mix

0x32060221

Mixing mechanism is busy

assembly is not initialized or is in the mixing action while a new command is received.

When 0x32060280

the

tube

gripper

When the mix assembly is initialized or the

returns, the Y direction home

Y motor is reset, the system detects that

position sensor is mistakenly

the Y direction home position sensor

11-18

Troubleshooting Information

triggered

generates a wrong jump signal. The Y-direction motor cannot drive the

0x32060281

Tube gripper failed to leave

sensor blade to leave the sensor area

the Y direction home position

home

position

during

mix

assembly

initialization 0x32060282

0x32060283

0x32060284

the tube gripper failed to

The Y-direction motor cannot drive the

return to the Y direction

sensor blade to the sensor area home

home position

position during mix assembly initialization

Tube gripper Y direction home

The Y direction home position sensor is still

position

blocked after the gripper is stretched out in

sensor

status

abnormal

the process of mixing action.

Tube gripper Y direction end

The Y direction end position sensor is still

position

blocked after the gripper is retracted in the

sensor

status

abnormal

process of mixing action.

Tube gripper Y direction end 0x32060285

position sensor is mistakenly triggered

The system detects that the Y direction end position sensor generates a wrong jump signal when the tube gripper is stretched out. The Y direction end position sensor is not

0x32060286

Tube gripper failed to stretch

triggered when the tube gripper is stretched

out in Y direction

out. It indicates that the gripper may fail to clamp the tube, so the alarm is sent. The Y direction home position sensor is not

0x32060287

tube gripper failed to retract in

triggered

when

the

tube

gripper

is

Y direction

retracted. It indicates that the gripper may fail to let go tube, so the alarm is sent.

When 0x32060290

the

tube

gripper

The system detects that the Z direction end

returns, the Z direction home

position sensor generates a wrong jump

position sensor is mistakenly

signal when the tube gripper lowers down

triggered

during the mixing action. The Z-direction motor cannot drive the

0x32060291

Tube gripper failed to leave

sensor blade to leave the sensor area

the Z direction home position

home

position

during

mix

assembly

initialization 0x32060292

0x32060293

0x32060294 0x32060295

tube gripper failed to return to the Z direction home position

The Z-direction motor cannot drive the sensor blade to the sensor area home position during mix assembly initialization

Tube gripper Z direction home

The Y direction home position sensor is still

position

blocked after the gripper lifts up in the

sensor

status

abnormal

process of mixing action.

Tube gripper Z direction end

The Y direction end position sensor is still

position

blocked after the gripper lowers down in the

sensor

status

abnormal

process of mixing action.

Tube gripper Z direction end

The system detects that the Z direction end

11-19

Troubleshooting Information

position sensor is mistakenly

position sensor generates a wrong jump

triggered

signal when the tube gripper lifts up during the mixing action.

0x32060296

0x32060297

The tube gripper fails to lift up

The Z direction end position sensor cannot

in the Z direction

be triggered when the tube gripper rises.

tube gripper fails to drop in the Z direction When

0x32060298

0x32060299

cannot be triggered when the tube gripper lowers down.

the

tube

gripper

When the mix assembly is initialized, the

returns, the Z direction home

system detects that the home position

position sensor is mistakenly

sensor in Z direction generates a wrong

triggered

jump signal.

Tube gripper Z direction end

The Z direction end position sensor is still

position

blocked after the gripper lowers down in the

sensor

status

abnormal When 0x32060300

The Z direction home position sensor

mix assembly initialization process. gripper

When the mix assembly is initialized or the

returns, the R direction home

the

tube

mixing action is performed, the system

position sensor is mistakenly

detects that the home position sensor in R

triggered

direction generates a wrong jump signal. The R-direction motor cannot drive the

0x32060301

Tube gripper failed to leave

sensor blade to leave the sensor area

the R direction home position

home

position

during

mix

assembly

initialization. 0x32060302

Tube gripper failed to return to the R direction home position Tube gripper R direction end

0x32060303

position

sensor

status

abnormal

The R-direction motor cannot drive the sensor blade to the sensor area home position during mix assembly initialization The R direction home position sensor is still blocked when the tube gripper shakes the tube, and the tube mouth is obliquely downward in the process of mixing action. The alarm is sent out when during the mixing action, when the tube gripper is

0x32060304

Tube gripper Z direction end

shaking the tube, the Z direction end

position

position

sensor

status

abnormal during mixing

sensor

suddenly

enters

the

unblocked status. It indicates the tube gripper drops down. Continuing mixing may damage the tube gripper. The R direction home position sensor is not

0x32060305

Tube gripper failed to go to the

triggered when the gripper shakes the tube

R direction home position

to the vertical direction in the process of mixing action.

Select Menu  Service  Debug&Self-test  Self-check  Mixing Mechanism to enter the mix assembly self-check screen. 11-20

Troubleshooting Information

Figure 11-7 Mix assembly self-test screen

11.2.7 Autoloader-Related Errors Detection principle The autoloader assembly is composed of the loading assembly, feeding assembly, unloading assembly, sample compartment assembly (for closed-sampling type instrument only), tube barcode rotatory scanning assembly, tube rack movement detection assembly, and tube detection assembly. Where: The loading assembly consists of one motor, one loading home position sensor, one loading end position sensor and one loading in-position micro-switch. The feeding assembly consists of one motor and one feed home position sensor. The unloading assembly consists of one motor and one unloading home position sensor. The sample compartment assembly consists of one motor and one sample compartment home position sensor. The rotatory scanning assembly consists of one tube fixing motor, one rotatory motor and one tube fixing detection sensor. The tube rack movement detection assembly consists of two sensors (one right counter sensor and one left counter sensor). The system determines whether the action is normal by the positions of the autoloader assemblies, moving distance and sensor status.

11-21

Troubleshooting Information

Error codes and error report mechanism 

Loading component alarms Table 11-13 Loading assembly error messages Error ID

Error message

Error report mechanism

Loading mechanism fails to 0x32060230

leave

sensor

area

in

initialization

The loading motor cannot take the sensor light barrier from the sensor detection area of home position when the automatic sampler is initialized. The loading motor cannot bring the sensor

0x32060231

Loading mechanism failed to

light barrier in the sensor detection area of

return to the home position

home position when the automatic sampler is initialized or loading is reset. When loading ends, the sensor at the

0x32060232

loading end position is not blocked and the

Loading stagnated

loading in-position detection switch is not triggered.

Abnormal status of the home 0x32060233

position sensor of loading mechanism Loading

0x32060234

position

mechanism sensor

After the autoloader is initialized or the

status

loading mechanism resets, the loading end position sensor is still blocked

returns, the home position sensor is mistakenly triggered

0x32060236

mechanism

end

position sensor is mistakenly triggered



the loading home position sensor is still

end

When the loading mechanism

Loading

blocked in the process of loading the tube, blocked.

abnormal

0x32060235

After the loading end position sensor is

When the loading mechanism claw returns to the home position, the system detects that the loading home position sensor generates a wrong jump signal. During the tube rack loading process, the system detects that the loading end position sensor generates a wrong jump signal.

Feeding mechanism alarms Table 11-14 Feeding mechanism error messages Error ID

Error message

Error report mechanism The feed motor cannot take the sensor light

Failed to break away from 0x32060250

sensor

during

feed

mechanism initialization

barrier from the sensor detection area of home position when the automatic sampler is initialized. The biggest possibility is that the sensor is damaged, e.g., the connector leaks.

11-22

Troubleshooting Information

The feed motor cannot bring the sensor 0x32060251

Feed mechanism failed to

light barrier into the sensor detection area

return to the home position

of home position when the automatic sampler is initialized.

0x32060253

0x32060254

Feed mechanism failed to move to the home position Feed mechanism failed to

The feed home position sensor is still

leave the home position

blocked when feeding ends.

the home position sensor to trigger the alarm by mistake Sensor mistakenly triggered

0x32060256

during feeding motor moving to home position



light barrier into the sensor detection area of home position when feeding is reset.

Feed mechanism returns to 0x32060255

The feed motor cannot bring the sensor

When the automatic sampler is initialized, the system detects that the feed home position sensor generates a wrong jump signal. During feeding mechanism resetting, the system detects that the feed mechanism home position sensor generates a wrong jump signal.

Tube rack movement detection errors

Every time the tube rack moves one step, the left/right pinch roller will undergo the following process: stopping at the tube rack groove  stopping at the tube rack step  stopping at the tube rack groove; the left/right counter will change status accordingly: blocked  not blocked  blocked, and the sensor output signal will have the level change process of ABA, i.e., a square signal is generated. When the left/right pinch roller stops at the tube groove or at the tube rack step, but the left/right counter sensor status are not consistent with expectation, the system sends out alarm. The system monitors the left/right counter sensor status based on the tube rack position and if the tube racks are continuously fed. Table 11-15 Feeding mechanism error messages Error ID

Error message

Error report mechanism During the tube rack feeding process, when the pinch roller should be at the groove, the

0x32060310

Counter sensor status error

left/right counter sensor is not blocked; or when the pinch roller should be at the step, the left/right counter sensor is blocked. When the tube rack is fed forward for one

0x32060311

Wrong counter count jump times

position, the left/right counter sensor does not generate the complete ABA square signal or has generated more than 1 square signal.

0x32060312

Manually move of tube rack

11-23

When the tube rack is not being fed (e.g., when the system is aspirating/mixing

Troubleshooting Information

sample or is waiting to aspirate/mix sample), the system monitors the ABA square signal generated by the left or right counter. In such cases, the system judges someone has manually move the tube rack, and reports error.



Unloading mechanism errors Table 11-16 Unloading mechanism error messages Error ID

Error message

Error report mechanism The unloading motor cannot drive the sensor blade to leave the sensor area

0x32060240

Unloading mechanism failed

home

position

during

autoloader

to leave home position

initialization. The biggest possibility is that the sensor is damaged, for example, by the leaked liquid at the connection position. The autoloader cannot drive the sensor blade to leave the sensor area home

0x32060241

Unloading mechanism failed

position during autoloader initialization.

to return to the home position

The biggest possibility is that the sensor is damaged, for example, by the leaked liquid at the connection position. The alarm is sent when the If the error cannot be removed, check whether there

0x32060242

are any foreign objects (e.g., screws) near

Unloading tray is full

the reflective sensor, and confirm whether the

reflective

sensor

connector

is

connected reliably. When the autoloader is initialized or 0x32060243

Sensor mistakenly triggered

unloading mechanism is reset, the system

during unloading mechanism

detects that the unloading mechanism

returning to home position

home position sensor generates a wrong jump signal. The unloading home position sensor is still blocked when the unloading action ends.

0x32060244

Unloading

mechanism

protruding failed

Check whether the sensor connector is connected reliably, if it is corroded by splashing liquid, and if the sensor cable skin is broken.



Rotatory scanning assembly errors

The tube fixing detection sensor in the rotatory scanning mechanism moves with the 11-24

Troubleshooting Information

mechanism, so the leading wire of sensor becomes a moving wire. If it is not fixed as required, the sensor wire skin may be broken or the inner core may be fractured. In this situation, the system may report any faults in Table 11-17 (except for "Scanner communication abnormal"), and the faults are accidental faults. Besides, the tube fixing mechanism in the rotatory scanning mechanism is just below the preheating bath. When servicing the preheating bath, avoid sprinkling reagent on the tube fixing mechanism; otherwise, the slide rail of tube fixing mechanism easily gets rusty or the motor or the sensor connector is easily corroded by the splashing liquid, causing a secondary fault. The following alarms will appear only on the instrument configured with the rotatory scanning mechanism. For users at administrator or common user level, all the following errors are displayed in the form of "Rotary scanning mechanism action error" except for "Scanner communication abnormal". Table 11-17 Rotatory scanning assembly error messages Error ID

Error message

Error report mechanism When executing the tube fixing command, the system detects that the tube fixing detection sensor has never left the rear

0x32060261

Tube fixing mechanism fixing

sensor barrier. Check whether the motor

tube error

and sensor connectors are connected reliably or get corroded by splashing liquid, and whether the sensor lead wire is broken or the internal core is fractured. After rotatory scanning, and during the whole processing of tube fixing mechanism returning to home position, and until the motor stops movements, the tube fixing

0x32060262

Tube

fixing

mechanism

releasing tube error

detection mechanism is always blocked by the rear sensor barrier. Check whether the motor

and

sensor

connectors

are

connected reliably or get corroded by splashing liquid, and whether the sensor lead wire is broken or the internal core is fractured. The tube fixing detection sensor cannot leave the sensor barrier when the rotatory scanning component is initialized. Check 0x32060263

Tube fixing mechanism failed

whether the motor and sensor connectors

to leave the home position

are connected reliably or get corroded by splashing liquid, and whether the sensor lead wire is broken or the internal core is fractured.

0x32060264

Tube fixing mechanism failed 11-25

The tube fixing detection sensor cannot

Troubleshooting Information

to return to home position

return to the sensor barrier position when the

rotatory

scanning

component

is

initialized. Check whether the motor and sensor connectors are connected reliably or get corroded by splashing liquid, and whether the sensor lead wire is broken or the internal core is fractured. The system detects wrong jump of the tube fixing detection sensor signal when the Sensor mistakenly triggered 0x32060265

during tube fixing mechanism returning to home position

rotatory scanning assembly is initialized or reset. Check whether the motor and sensor connectors are connected reliably or get corroded by splashing liquid, and whether the sensor lead wire is broken or the internal core is fractured. When autoloading is started, the system will check its communication with the scanner. The alarm will be triggered if communication cannot be established with the scanner.

0x32060266

Scanner

communication

abnormal

When this error occurs, check whether the scanner is connected to the autoloader board reliably (including connection of the scanner transfer line connector). If the connection is proper but the error cannot be

removed,

the

scanner

may

be

damaged. During the autoloading process, the system detects that the tube fixing detection sensor is triggered earlier than expected, which may happen because the tube fixing mechanism slide rail of getting rusted and cannot move due to splashing liquid.

0x32060267

Tube fixing mechanism slide

Usually this error can be removed by

rail is stuck

tapping "Remove Error" button. However, it will re-appear in the next autoloading process. When this error takes place, first check whether the slide rail of tube fixing mechanism gets rusted (when sliding the rail, the resistance is large). In this case, use lubricating oil to clean and lubricate the slide rail and make sure that the slide rail 11-26

Troubleshooting Information

can slide easily. Replace the whole tube fixing mechanism when necessary. If the slide rail does not get rusted, the greatest possibility is that the sensor lead wire is broken or the outer skin is damaged.



Tube detection errors

The following alarms will appear only on the instrument not configured with the rotatory scanning mechanism. Table 11-18 Tube detection sensor error messages Error ID

Error message

Error report mechanism When autoloading is started, the system will check for the tube detection sensor. The alarm will be triggered if it detects the sensor is blocked. This error may occur when after an abnormal shutdown, the tube racks in the analysis area are not taken away. If the error still cannot be removed when all the tube racks in the analysis area are taken away, tap . Tap and observe whether the turn-on voltage and turn-off voltage are in the acceptable ranges. If not, check whether the connector of tube detection sensor is connected reliably or gets corroded by leaking liquid. Replace the sensor with a new one when necessary. If the turn-on voltage and turn-off voltage are still not in the acceptable ranges, tap the button to observe the change rate of the current blank voltage from the blank voltage of last calibration. If the change rate exceeds 1.3 times, tap the

sensor.

11-27

button to

recalibrate the

Troubleshooting Information

Figure 11-8 Tube detection sensor debugging screen

11.2.8 Sample Compartment Assembly Errors Detection principle The sample compartment assembly (for closed-sampling type analyzers) contains one motor and one home position sensor. The system judges whether its action is normal by detecting the compartment close/open status and its home position blocked/unblocked status. The sample compartment error will occur on the closed-sampling type analyzers. Error codes and error report mechanism For users at administrator or common user level, all the following errors are displayed in the form of "Sample compartment action abnormal". Table 11-19 Sample compartment assembly error messages Error ID

Error message

Error report mechanism This alarm is triggered when the system

0x32060314

Sample compartment status

receives a command of opening/closing

error

sample compartment before the sample compartment completes initialization. The sample compartment motor cannot

0x32060270

Sample compartment failed to

drive the sensor blade to leave the sensor

leave home position

area

home

position

during

sample

compartment initialization 0x32060271

Sample compartment failed to

The sample compartment motor cannot

return to home position

drive the sensor blade to the sensor area 11-28

Troubleshooting Information

home position during sample compartment initialization The system performs the opening sample 0x32060272

Sample compartment failed to

compartment

action,

but

detects the

open

sample compartment home position sensor is still blocked. When

0x32060273

the

sample

compartment

is

Sensor mistakenly triggered

initialized or closed, the system detects that

during sample compartment

the home position sensor of the sample

returning to home position

compartment generates a wrong jump signal. The alarm is triggered when the system detects that the sample compartment home position sensor is blocked before the sample compartment is closed.

Sample compartment home 0x32060274

position

sensor

status

abnormal

If the error is not caused because someone has

manually

closed

the

sample

compartment, check whether the sample compartment home position sensor is connected reliably, or if the sensor is damaged. Select Menu  Service  Debug & Self-Test  Self-Test  Other Components  Sample Compartment to enter the sample compartment assembly self-check screen.

Figure 11-9 Sample compartment self-check screen

11-29

Troubleshooting Information

11.2.9 Temperature Type Errors Detection principle The system monitors the temperature of the following: WBC reaction bath temperature, RET reaction bath temperature, preheating bath temperature, optical system, instrument internal temperature, PMT temperature and RBC diluent temperature. Here, the WBC reaction bath, RET reaction bath, preheating bath, and optical system are modules with the heating function. After the instrument is powered on, the system will dynamically set the target temperature values for the WBC reaction bath, RET reaction bath and preheating bath according to the instrument internal temperature. And it controls the temperatures in WBC reaction bath, RET reaction bath and preheating bath in a relatively stable range through a closed loop control system composed of the heater and temperature sensor. The instrument internal temperature, PMT temperature and RBC diluent temperature are monitored, but the corresponding channels cannot be heated. The system has two thresholds for temperature, one for reporting alarm, the other for limiting analysis. When the temperature of one or more channels exceeds the alarm thresholds, but does not exceed the limiting analysis thresholds, the instrument prompts alarm but does not shield the results, and the measurement is not stopped; when the temperature of a certain or several channels exceeds the limiting analysis thresholds, the instrument prompts an alarm, shields the results, and stops the subsequent measurement. Error codes and error report mechanism When abnormal temperatures are reported, first judge if it is a positive or false alarm. For example, when the system reports "WBC reaction bath temperature out of the upper limit for counting", first put your hand near the WNB/DIFF reaction bath to feel if the reaction bath temperature is really high. If the reaction bath is cool, it is a false alarm. Another example, if the system reports "Temperature inside the analyzer out of the lower limit for counting", but the room temperature is 25°C, obviously it is a false alarm. Causes of the false alarm: The temperature sensor connector is not connected reliably or gets corroded by leaking liquid, or the temperature sensor is damaged (e.g., the welding of built-in chip is poor). Causes of the real alarm: The heater/temperature protection switch connectors are not connected reliably (which will lead to a low temperature fault), drive board closed loop temperature control fails, the power supply power is insufficient, etc. Table 11-20 Temperature error messages Error ID

Error message WBC

0x32061000

reaction

Error report mechanism bath

temperature out of the upper limit for counting

0x32061001

RET

reaction

The WBC reaction bath temperature is higher than the target temperature by +5℃. The alarm will shield the results and end autoloading analysis in advance.

bath

The RET reaction bath temperature is

temperature out of the upper

higher than the target temperature by +5℃.

11-30

Troubleshooting Information

limit for counting.

The alarm will shield the results and end autoloading analysis in advance.

0x32061002

0x32061003

Preheating bath temperature

The preheating bath temperature is higher

out of the upper limit for

than 45℃. The alarm will shield the results

counting.

and end autoloading analysis in advance.

Optical system temperature

The optical system temperature is higher

out of the upper limit for

than 45℃. The alarm will shield the results

counting.

and end autoloading analysis in advance.

Temperature 0x32061004

0x32061005

0x32061006

the

Temperature inside the analyzer is higher

analyzer out of the upper limit

than 45℃. The alarm will shield the results

for counting

and end autoloading analysis in advance.

PMT temperature out of the upper limit for counting.

of the upper limit for counting. reaction

bath

temperature out of the lower limit for counting RET

0x32061011

reaction

bath

temperature out of the lower

out of the lower limit for counting

0x32061015

0x32061016

end autoloading analysis in advance. The WBC reaction bath temperature is smaller than the target temperature by 5℃. The alarm will shield the results and The RET reaction bath temperature is lower than the target temperature by -5℃. The alarm will shield the results and end The preheating bath temperature is lower than the target temperature by -5℃. The alarm will shield the results and end

Optical system temperature

The optical system temperature is lower

out of the lower limit for

than 28℃. The alarm will shield the results

counting

and end autoloading analysis in advance. the

Temperature inside the analyzer is lower

analyzer out of the lower limit

than 3℃. The alarm will shield the results

for counting

and end autoloading analysis in advance.

inside

PMT temperature out of the lower limit for counting

of the lower limit for counting reaction

The PMT temperature is lower than 27℃. The alarm will shield the results and end autoloading analysis in advance.

RBC diluent temperature out

WBC 0x32061020

45℃. The alarm will shield the results and

autoloading analysis in advance.

Temperature 0x32061014

The RBC diluent temperature is higher than

autoloading analysis in advance.

Preheating bath temperature

0x32061013

The alarm will shield the results and end

end autoloading analysis in advance.

limit for counting

0x32061012

The PMT temperature is higher than 45℃. autoloading analysis in advance.

RBC diluent temperature out

WBC 0x32061010

inside

The RBC diluent temperature is lower than 3℃. The alarm will shield the results and end autoloading analysis in advance.

bath

The WBC reaction bath temperature is

temperature out of the upper

higher than the target temperature by +3℃

limit for alarm

but not higher than the target temperature 11-31

Troubleshooting Information

by +5 ℃ . The alarm is just a prompt message; the results are not shielded and measurement is not stopped. RET 0x32061021

reaction

bath

temperature out of the upper limit for alarm

The RET reaction bath temperature is higher than 38 ℃ . The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The preheating bath temperature is higher

0x32061022

Preheating bath temperature out of the upper limit for alarm

than the target temperature by 3℃ but not higher than 45 ℃ . The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The optical system temperature is higher

0x32061023

Optical system temperature out of the upper limit for alarm

than 38℃ but not higher than 45℃. The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The internal ambient temperature is higher

0x32061024

Internal ambient temperature out of the upper limit for alarm

than 36℃ but not higher than 45℃. The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The PMT temperature is higher than 38℃

0x32061025

PMT temperature out of the

but not higher than 45℃. The alarm is just

upper limit for alarm

a prompt message; the results are not shielded and measurement is not stopped. The RBC diluent temperature is higher than

0x32061026

RBC diluent temperature out of the upper limit for alarm

36℃ but not higher than 45℃. The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The WBC reaction bath temperature is

WBC 0x32061030

reaction

bath

temperature out of the lower limit for alarm

smaller than the target temperature by -3℃ but not smaller than the target temperature by -5 ℃ . The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The RET reaction bath temperature is

RET 0x32061031

reaction

bath

temperature out of the lower limit for alarm

smaller than the target temperature by -3℃ but not smaller than the target temperature by -5 ℃ . The alarm is just a prompt message; the results are not shielded and measurement is not stopped.

0x32061032

Preheating bath temperature 11-32

The preheating bath temperature is lower

Troubleshooting Information

out of the lower limit for alarm

than the target temperature by -3℃ but not lower than target temperature -5℃. The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The optical system temperature is lower

0x32061033

Optical system temperature out of the lower limit for alarm

than 30℃ but not lower than 28℃. The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The internal ambient temperature is lower

0x32061034

Internal ambient temperature out of the lower limit for alarm

than 12 ℃ but not lower than 3 ℃ . The alarm is just a prompt message; the results are not shielded and measurement is not stopped. The PMT temperature is lower than 29℃

0x32061035

PMT temperature out of the

but not lower than 27℃. The alarm is just a

lower limit for alarm

prompt message; the results are not shielded and measurement is not stopped. The RBC diluent temperature is lower than

0x32061036

RBC diluent temperature out

12℃ but not lower than 3℃. The alarm is

of the lower limit for alarm

just a prompt message; the results are not shielded and measurement is not stopped.

0x32061040

0x32061041

0x32061042

WBC reaction bath does not

At the end of the specified startup

achieve target temperature

completed

after startup procedure

temperature of the assembly (with heating

RET reaction bath does not

module)

achieve target temperature

temprature. Generally the fault occurs

after startup procedure

because the assembly is not heated or the

Preheating bath does not

heating power is not enough. Check the

achieve target temperature

follows:

after startup procedure Optical 0x32061043

system

does

not

achieve target temperature after startup procedure

0x32061044

time cannot

point, reach

the the

target target

① If the 24V power supply works normal; ② If the heating rod connector and the

PMT does not achieve target

temperature protection switch connector of

temperature

the corresponding channel are connected

after

startup

reliably.

procedure

Select Menu  Status  Temperature & Pressure to view the temperature value of each channel. When the temperature sensor and the circuit are normal, the temperature value displayed is close to the real temperature.

11-33

Troubleshooting Information

Figure 11-10 Temperature status screen

11.2.10 Pressure Errors Detection principle The system uses one pressure pump and three air tanks to build three positive pressures; and one vacuum pump and two air tanks to build two negative pressures. One pressure sensor is set for the 120 kPa and -40 kPa pressure channels respectively to control the pressure balance. When the pressure reaches the set range, the pressure pump or the vacuum pump stops working. When there is a problem in the pump control or the sealing property of the air tank is poor, then abnormal 120 kPa/-40 kPa pressure will be reported. While 90 kPa and 50 kPa are split from 120 kPa, with valves installed on both the splitting channels. When the 90 kPa/50 kPa pressure is lower than the set range, the valve is opened, and the high pressure air enters the 90 kPa/50 kPa air cell from the 120 kPa air tank to increase the 90 kPa/50 kPa air cell pressure; when the 90 kPa/50 kPa pressure is higher than the set range, the value is closed. When the valve on/off control does not work well, or the sealing of the 90kPa/50kPa air cell is poor, the system will report the abnormal 90 kPa/50 kPa pressure. The -30 kPa pressure is splitted from the -40 kPa, with a valve installed on the splitting channel. The principle is similar to that of the 90 kPa and 50 kPa channels. Error codes and error report mechanism Table 11-21 Pressure error messages Error ID

Error message

Error report mechanism The system detects that any one of three

0x32060401

Auto pressure building out of

pressure or the two vacuums fails to reach

time

the set pressure range in sequencedefined time. 11-34

Troubleshooting Information

At the sequence-defined time point, the 90 0x32060500

120kPa pressure out of range

kPa pressure build-up sensor detects a pressure exceeding the defined range. At the sequence-defined time point, the 90

0x32060501

90 kPa pressure out of range

kPa pressure build-up sensor detects a pressure exceeding the defined range. At the sequence-defined time point, the 90

0x32060502

50 kPa pressure out of range

kPa pressure build-up sensor detects a pressure exceeding the defined range. At the sequence-defined time point, the 90

0x32060503

-40 kPa pressure out of range

kPa pressure build-up sensor detects a pressure exceeding the defined range. At the sequence-defined time point, the 90

0x32060504

-30 kPa pressure out of range

kPa pressure build-up sensor detects a pressure exceeding the defined range. The 120 kPa pressure build-up sensor

0x32060505

120kPa pressure is higher

detects a pressure higher than 170 kPa. If

than upper limit

this situation is allowed to continue, there is a risk of tube damage. The hydraulic sensor detects the liquid pressure in the sampling tube exceeds the

0x32060410

Liquid pressure out of range

normal range. Possible causes include that the tube is broken, the probe is blocked, or the hydraulic sensor is damaged. The system detected that the blank voltage

Blank voltage of the liquid 0x32060414

pressure sensor is out of range

of the hydraulic sensor exceeds the normal range when there is no fluid pressure in the tube. Possible causes include that the tube is broken, the probe is blocked, or the hydraulic sensor is damaged.

Select Menu  Status  Temp & Pressure to view the pressure value of each channel. When the pressure sensor and the circuit are normal, the pressure values displayed are close to the real pressure. By tapping the and buttons on the screen, one can roughly judge the sealing property of the air tank/air cell and whether the valves on the splitting channels operate normally.

11-35

Troubleshooting Information

Figure 11-11 Pressure status screen

11.2.11 Voltage/Current Errors Detection principle / Error codes and error report mechanism Table 11-22 Voltage/current error messages Error ID

Error message

0x32061050

12V voltage abnormal

0x32061051

24V voltage abnormal

0x32061052

PMT voltage abnormal

Error report mechanism 12V is out of the [11.5V, 12.5V] range Power 24V is out of the [22.8V, 25.25V] range PMT is out of the [22V, 33V] range The actual PMT voltage exceeds the PMT

0x32061059

PMT gain abnormal

voltage alarm range in either the DIFF, WNB and RET channels. The HGB blank voltage exceeds the [3.2V, 4.8V] range. Possible causes include:

0x32061056

HGB blank voltage abnormal

(1) There are bubbles in the diluent in the HGB reaction bath; (2) Liquid leaks from the HGB reaction bath

11-36

Troubleshooting Information

and flows to the HGB lamp; (3) The light intensity of HGB lamp has been weakened or enhanced, and the HGB gain needs to be calibrated again. The laser power exceeds the [9.5 mW, 10.5

0x32061057

Laser power abnormal

0x32061058

Laser drive current abnormal

0x32061060 0x32061061 0x32061062

DIFF

channel

FS

mW] range.

blank

voltage abnormal WNB

channel

The laser driven current exceeds the allowable range. DIFF channel FS blank voltage exceeds the set threshold.

FS

blank

WNB channel FS blank voltage exceeds

voltage abnormal

the set threshold.

RET channel FS blank voltage

RET channel FS blank voltage exceeds the

abnormal

set threshold.

Select Menu  Status  Voltage & Current to view the voltage/current value.

Figure 11-12 Voltage and current status screen

11.2.12 Fan Type Detection principle The cooling fan has a built-in sensor. When the fan runs, the fan output end will generate a square wave signal. When the fan stops, there is no square wave signal. The system judges if the fan is stalled by checking whether there is square wave signals from the fan output end.

11-37

Troubleshooting Information

Error codes and error report mechanism Table 11-23 Fan error messages Error ID 0x32061070

Error message

Error report mechanism

Radiator fan in the analyzer is

The system detects that the fan at the back

blocked

of main unit stops.

Select Menu  Service  Debug & Self-test  Self-test  Other Components  Fan to test the fan.

Figure 11-13 Fan self-check screen

11.2.13 Signal type Detection principle The system checks the DC offset voltages of the FS, SS, FL and HGB channels at the specific time sequence nodes during the analyzer startup process, and reports error when any of the offset voltages exceed the allowable range. Error codes and error report mechanism Possible causes of reporting the abnormal FS, SS and FL baseline: The optical signal board in optical system is damaged; The main control board circuit is damaged; The signal line connection between the optical system signal board and the main control board is not reliable.

11-38

Troubleshooting Information

Possible causes of reporting abnormal HGB baseline: The analog board is damaged; The main control board circuit is damaged; The signal line connection between the analog board and the main control board is not reliable. Table 11-24 Signal error messages Error ID

Error message

Error report mechanism During analyzer startup, the system detects

0x32060090

FS baseline abnormal

that the FS channel baseline exceeds the allowable range. During analyzer startup, the system detects

0x32060091

SS baseline abnormal

that the SS channel baseline exceeds the allowable range. During analyzer startup, the system detects

0x32060092

FL baseline abnormal

that the FL channel baseline exceeds the allowable range. During analyzer startup, the system detects

0x32060093

HGB baseline abnormal

that the HGB channel baseline exceeds the allowable range.

11.2.14 Communication Type Detection principle When the main control board sends a command to the drive board or autoloader board, but receives no reply, the system reports the communication timeout error Error codes and error report mechanism The possible cause for the communication time out fault is that the communication line connection between the main control board and the drive board/autoloader board is not reliable. Table 11-25 Signal error messages Error ID 0x32060404

0x32060405

Error message Autoloader

Error report mechanism board

communication out of time

The main control board sends a command to the autoloader board, but receives a reply within the specified time.

Drive board communication out of time

The main control board sends a command to the drive board, but receives no reply within the specified time.

11-39

Troubleshooting Information

11.2.15 System Errors Detection principle The instrument judges whether there is any problem by checking the signals or results. Error codes and error report mechanism Table 11-26 System error messages Error ID

Error message

Error report mechanism The alarm is triggered when the startup process is interrupted. Solve the problem

0x32060402

Startup

initiation

not

performed

that interrupts the startup process, and this error can be removed. Tap the "Remove Error" button to remove the error, and the instrument will automatically perform the startup process. The background results tested during the

0x32060407

Background abnormal

startup process are out of specification range During the measurement, the average voltage of the aperture exceeds the set range. Possible causes include (1) The aperture is really clogged. Tap

0x32060409

Clogging

"Remove Error" to solve the problem. If the error still exists, try to perform Probe Cleanser maintenance procedure to the aperture. (2) The electrical conductivity drops after the diluent is frozen and rewarmed. This alarm will be triggered when the process of exiting shallow standby status is

0x32060411

Exiting shallow standby status failed

interrupted.

Solve

the

problem

that

interrupts the process, and this error can be removed. Tap the "Remove Error" button to remove the error. And the instrument will automatically perform the process again. This alarm will be triggered when the process of exiting deep standby status is

0x32060412

Exiting deep standby status

interrupted.

Solve

the

problem

that

failed

interrupts the process, and this error can be removed. Tap the "Remove Error" button to remove the error. And the instrument will

11-40

Troubleshooting Information

automatically perform the process again. This alarm will be triggered when the process of auto startup is interrupted. Solve the problem that interrupts the process, 0x32060413

Auto startup failed

and this error can be removed. Tap the "Remove Error" button to remove the error. And the instrument will automatically perform the process again. When the FCM bath sequence is being executed, the FCM bath floater does not

0x32060406

FCM priming out of time

float up as required at the sequencedefined time point (i.e. the FCM bath is not primed full)

0x32060415

FCM bath priming failed!

0x32061071

Front cover is open

0x32061072

The DIL syringe fails to respond to the FCM bath priming command. The front cover detection sensor is in the non-blocked status.

Optical system shielding box is open

The system detects that the optical system shielding box detection switch is not pressed down. The error only occurs when the main control board battery runs out of power. To

0x32061073

System time error

remove the error, replace the battery, and reset the date and time. Then tap "Remove Error".

11.2.16 Additional Warning Messages in the “Message” Area (Since EIV012) When “PLT analysis abnormal” displayed in the Message area, it means the PLT-I channel may have electrical interference. The PLT-related parameter results (PLT, MPV, PCT, PDW, P-LCR, P-LCC, PDW-SD) are flagged with the “R” flag or displayed as ****. When “PLT-O analysis abnormal” displayed in the Message area, it means the second time background test in the PLT-O channel sees unexpected/excessive particles. may have electrical interference. The PLT-related parameter results (PLT, MPV, PCT, PDW, P-LCR, PLCC, PDW-SD) are flagged with the “R” flag or displayed as ****.

11-41

A

List of Wearing Parts Frequency of replacement

Piercer

PN

115-033912-00

Probe wipe

PWD

041-023727-00

Liquid filter

LF1

115-011660-00

Liquid filter

LF2

115-011660-00

Liquid filter

LF4

115-010567-00

Pinch valve tube Air pump

PV05/PV06 pinch valve tube P1

M6G-020011--082-002562-00

A-1

Piercer Piercing probe wipe Waste filter

100000 times of piercing 100000 times of piercing 60000 times of working / one year

Probe wipe

60000 times of working /

filter

one year

Sheath fluid

45000 times of working /

filter

one year

Pinch valve

60000 times of working /

tube (yellow)

one year

Air pump

2000H

B

New/Changed Functions Lists with each ECR

This section records new or changed functions with each ECR. ECR

New/changed functions

Description

EIV012

Software debug: correct

Before EIV012, when tapping “Horizontal Pos.”

the sample probe position

observe button at the “Adj, Sample Probe

at WNB bath after tapping

Pos.”-“WNB bath pos.” screen,

“Horizontal

probe moves to a position about 2.5mm from

Observe”

button

the sample

the centre of the WNB bath. EIV012 corrects the design. After tapping “Horizontal Pos.”, the sample probe moves horizontally and stays at a position above the target position (around the centre of its working position in the Y direction). See 4.6.1 Adjust. Sample Probe Positions

EIV013

New optical assembly goes

6.3.5

Replacing

Optical

Assembly

after

on-line

Analyzer Upgrading with the New Optical Assembly and New Optical Signal Board (After EIV013)

When the operator goes to

4.7 Status

the sensor status screen, moments placed on certain motors will be released Software

supports

the

7.13 Check the Particle Flow Stability

Stability Graph labXpert

supports

Logging in labXpert with your service level

“importing” re-tests results

account, and click “import” on the tool bar. The

at service level

software now supports importing re-tests information (including sample imformation, blood sample tests analysis information, rules application results, parameter results and flag messages)

EIV014

The “Debug Data Export”

4.9.2 Debug Data Export

function supports export LIS logs. The

blank

adjustment

photovoltage screen

/

is

removed Software adjusts the layout

The sample compartment self-test and the fan

of the self-test screen.

self-test are placed under one tab. B-1

Troubleshooting Information

Correction：

Hardware diagram: remove the RFID board from the diagram 7.8.7, error correction, LF1 is for waste fitler, and LF2 is for wipe filter. 6.3.3-6.3.4, update the instruction for laser diode current adjustment and the replacement of optical system. Main changes include: 

Add instruction that service should always check diode current on the software after optical system debugging/maintenance;



When replacing the optical system, no need to replace the diode drive board.

B-2

P/N:046-011141-00(5.0)