Zybio Z3 Manuale utente

AUTO HEMATOLOGY ANALYZER

SERVICE MANUAL

Intellectual Property

ZYBIO INC. (hereinafter called ZYBIO) owns the intellectual property rights to this ZYBIO 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 ZYBIO, or of others.

ZYBIO 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

ZYBIO 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

ZYBIO is strictly forbidden.

is the trademarks, registered or otherwise, of ZYBIO in China and other countries.

All other trademarks that appear in this manual are used only for informational or editorial

purposes. They are the property of their respectiveowners.

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. ZYBIO 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.

ZYBIO 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 ZYBIO 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.

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 analyzer under the situation specified in this manual; otherwise,

the analyzer will not work normally and the analysis results will be unreliable, which

would damage the analyzer components and cause personal injury.

Table of Contents

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

Warranty

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

IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR

PURPOSE.

Exemptions

ZYBIO's obligation or liability under this warranty does not include any transportation or other

charges or liability for direct, indirect or consequential damages or delay resulting from the

improper use or application of the product or the use of parts or accessories not approved by

ZYBIO or repairs by people other than ZYBIO authorized personnel.

This warranty shall not extend to:

Malfunction or damage caused by improper use or man-made failure.

Malfunction or damage caused by unstable or out-of-range power input.

Malfunction or damage caused by force majeure such as fire and earthquake.

Malfunction or damage caused by improper operation or repair byunqualified or

unauthorized service people.

Malfunction of the instrument or part whose serial number is not legible enough.

Others not caused by instrument or part itself.

Customer Service Department

Manufacturer:

ZYBIO INC.

Address:

Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao

Industrial Park, Dadukou District, Chongqing 400082, P. R. China.

Website:

www.zybio.com

E-mail Address:

service@zybio.com

Tel:

+86 023 68655509

NOTE

Table of Contents 
 
 
 
 
Contents 
1 Using This Manual..........................................................................................................................1
1.1
 Overview..........................................................................................................................1
1.2
 Who Should Read This Manual..........................................................................................1
1.3
 Conventions Used in This Manual......................................................................................1
1.4
 Safety Information ............................................................................................................2
1.5
 When you see....................................................................................................................3
2Product Specifications.....................................................................................................................6
2.1
 Product Name...................................................................................................................6
2.2
 Physical Specifications......................................................................................................7
2.3
 Electrical Specifications ....................................................................................................7
2.4
 Environment Requirements................................................................................................8
2.5
 Product Specifications.......................................................................................................8
2.5.1 Sample mode.......................................................................................................8
2.5.2 Throughput..........................................................................................................8
2.6 Testing Parameters ............................................................................................................8
2.7 Performance Requirements................................................................................................9
2.7.1 Background/Blank Count .....................................................................................9
2.7.2 Carryover ............................................................................................................9
2.7.3 Repeatability......................................................................................................10 
2.7.4 Linearity............................................................................................................11 
2.8 Display Range ................................................................................................................12 
2.9 Product Description.........................................................................................................12 
2.9.1 Main unit...........................................................................................................13 
2.9.2 Power/status indicator ........................................................................................13 
2.9.3 Power input socket.............................................................................................14 
2.9.4 [Aspiration] Key................................................................................................14 
2.9.5 USB ports..........................................................................................................14 
2.10 Product Configuration .....................................................................................................14 
2.11 Reagents, Controls and Calibrators...................................................................................14 
2.11.1 Reagents............................................................................................................15 
2.11.2 Controls and Calibrators.....................................................................................15 
2.12 Information StorageCapacity.............................................................................................15 
3System Principles..........................................................................................................................16 
3.1
 Introduction....................................................................................................................16 
3.2
 Analyzer Workflow.........................................................................................................16 
3.3
 Aspiration.......................................................................................................................17 

Table of Contents 
 
 
 
4
 Dilution..........................................................................................................................17 
5
 WBC Measurement.........................................................................................................17 
5.1 Measurement Principle:......................................................................................17 
5.2 WBC-Related Parameters...................................................................................18 
5.3 HGB Measurement ............................................................................................20 
6
 RBC/PLT Measurement...................................................................................................20 
6.1 Impedance Method.............................................................................................20 
6.2 RBC-Related Parameters....................................................................................21 
6.3 PLT-Related Parameters......................................................................................22 
7
 Wash..............................................................................................................................23 
Software and Interface ..................................................................................................................24 
1. Login ................................................................................................................................24 
2
 Review...........................................................................................................................24 
2.1 Trend Graph.......................................................................................................24 
3
 Calibration......................................................................................................................25 
3.1 Calibration Factors.............................................................................................25 
3.2 Calibration with Calibrator .................................................................................25 
4
 Gain Setup......................................................................................................................27 
5
 Performance ...................................................................................................................28 
5.1 Background Count.............................................................................................28 
5.2 Reproducibility..................................................................................................28 
5.3 Carryover ..........................................................................................................28 
6
 Advanced Toolbox..........................................................................................................28 
6.1 Export ...............................................................................................................28 
7
 Software Update .............................................................................................................29 
8
 Status Indicator ...............................................................................................................30 
9
 Buzzer............................................................................................................................30 
5Fluidics ........................................................................................................................................31 
1
 Introduction to Fluidic Parts.............................................................................................31 
1.1 Valves...............................................................................................................31 
1.2 LVM fluidic valve..............................................................................................32 
1.3 Linkage Syringe Device .....................................................................................32 
1.4 Vacuum pump....................................................................................................33 
1.5 Air pump...........................................................................................................33 
1.6 Sample probe.....................................................................................................34 
1.7 Probe wipes .......................................................................................................34 
1.8 Baths.................................................................................................................35 
2
 Sample Dilution Flow Chart............................................................................................36 
2.1 Whole Blood Mode............................................................................................36 
2.2 Pre-dilute Mode.................................................................................................36 
3
 Introduction to Fluidic Channels ......................................................................................37 
3.1 WBC/HGB channel............................................................................................37 
3.2 RBC/PLT channel ..............................................................................................37 
4
 Sample Volume...............................................................................................................37 

Table of Contents 
 
 
 
 
5
 Introduction to Sequences................................................................................................38 
5.1 Fluidic diagram..................................................................................................38 
5.2 Sample Aspiration..............................................................................................38 
5.3 WBC Chamber Drain.........................................................................................39 
5.4 Sample Probe Outside Wash...............................................................................39 
5.5 WBC Diluent Adding.........................................................................................40 
5.6 Add Sample with Diluent ...................................................................................40 
5.7 Mix WBC and RBC Chamber.............................................................................41 
5.8 Aspirate Lyse.....................................................................................................41 
5.9 WBC Chamber Add Lyse with Diluent ...............................................................42 
5.10 Counting Blood Cell ..........................................................................................42 
5.11 Probe Cleanser Maintenance (Shutdown Sequence) .............................................43 
5.12 Cleaning Procedure during Startup......................................................................43 
5.13 Standby.............................................................................................................43 
6Hardware System..........................................................................................................................44 
1 Hardware System Function Block Diagram ......................................................................44 
2 Electrical Connection Diagram ........................................................................................45 
3 System Problem..............................................................................................................45 
4 Main Control Board........................................................................................................47 
4.1 Introduction.......................................................................................................47 
4.2 Components.......................................................................................................47 
4.3 Debugging and Troubleshooting .........................................................................50 
4.4 Troubleshooting for Main Control Board.............................................................51 
5 Motor drive board...........................................................................................................55 
5.1 Introduction.......................................................................................................55 
5.2 Components.......................................................................................................55 
5.3 Debugging and Troubleshooting .........................................................................56 
5.4 Troubleshooting for Motor drive Board...............................................................57 
6 Power board....................................................................................................................58 
6.1 Introduction.......................................................................................................58 
6.2 Power Board Replacing and Wiring ....................................................................59 
6.3 Power Board Problem ........................................................................................60 
7 Touch Screen Control Board............................................................................................61 
7.1 Introduction.......................................................................................................61 
7.2 Components.......................................................................................................61 
7.3 TouchScreen Control Board Problem..................................................................61 
8 Indicator Board...............................................................................................................62 
8.1 Introduction.......................................................................................................62 
8.2 Components.......................................................................................................63 
8.3 Indicator Board problem.....................................................................................63 
9 Motors, Photocouplers and Micro-switches ......................................................................63 
9.1 Introduction.......................................................................................................63 
9.2 Motor and Photocoupler problem........................................................................64 
10 Liquid Detection Board...................................................................................................65 

Table of Contents 
 
 
 
 
10.1 Introduction.......................................................................................................65 
10.2 Components.......................................................................................................65 
10.3 Liquid detection board problem ..........................................................................65 
7Mechanical System.......................................................................................................................66 
1 Introduction to Mechanical Structure................................................................................66 
1.1 Front of the Analyzer .........................................................................................66 
1.2 Front of the Analyzer (front cover open) .............................................................66 
1.3 Back of the analyzer...........................................................................................67 
1.4 Left Side of the Analyzer....................................................................................67 
1.5 Left side of the analyzer (left door open).............................................................68 
1.6 Right Side of the Analyzer (right door open)........................................................68 
2 Overview of Assemblies..................................................................................................69 
2.1 Introduction.......................................................................................................69 
2.2 Whole Device Explosive view ............................................................................69 
2.3 Sampling System ...............................................................................................70 
2.4 Cell counting assembly.......................................................................................70 
2.5 WBC chamber assembly.....................................................................................71 
2.6 Power supply assembly ......................................................................................71 
2.7 Vacuum tank assembly.......................................................................................72 
2.8 Vacuum pump assembly.....................................................................................72 
2.9 Air pump...........................................................................................................72 
2.10 Valve assembly..................................................................................................73 
2.11 Syringe assembly...............................................................................................73 
2.12 Front cover assembly .........................................................................................73 
8Troubleshooting............................................................................................................................74 

1 Using This Manual

1.1

Overview

This chapter describes how to use the service manual. In this manual, the repair methods of Z3

are described in detail. Before servicing Z3, 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 Z3 Operator’s manual. It does not contain

information and procedures already covered in the Operator’s manualof Z3.

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

this manual and the operator’s manual.

1.2

Who Should Read 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 diagramsand fluidic charts.

1.3

Conventions Used in This Manual

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

Format

Meaning

[××]

all capital letters enclosed in [ ] indicate a key name (either on

the pop-up keyboard or the external keyboard)

“××”

letters included in " " indicate text you can find on the screen of

××

italic letters indicate titles of the chapters that are referred to

All illustrations in this manual are provided as examples only. They may not necessarily reflect your

analyzer setup or data displayed.

1.4

Safety Information

You will find the following symbols in this manual.

Symbols

Meaning

Read the statement below the symbol. The statement is alerting you

to a potentially biohazardous condition.

WARNING

Read the statement below the symbol. The statement is alerting you

to an operating hazard that can cause personnel injury.

CAUTION

Read the statement below the symbol. The statement is alerting you

to a possibility of analyzer damage or unreliable analysis results.

NOTE

Read the statement below the symbol. The statement is alerting you

to information that requires your attention.



All the samples, controls, calibrators, reagents, wastes and areas contacted by them are

potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab

coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.



If the main unit of the instrument leaks, the leaked liquid is potentially biohazardous.

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.



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

the analyzer. Otherwise, the risk of explosion may exist.



Contacting exposed electronic components while the equipment is attached to power can

cause personal injury from electric shock or damage to electronic components. Power

down before removing covers to access electronic components.



Connect the analyzer to a socket having sole fuse and protective switch. Do not use the

same fuse and protective switch with other equipment (e.g. life supporting equipment).

Otherwise, the equipment failure, over current or impulse current that occurs at the

startup moment may lead to tripping.



To prevent personal injury during the maintenance, keep your clothes, hairs and hands

from the moving parts, such as the sample probe.



Possible mechanical movement of the warned position may lead to personal injury during

normal operation, removal, maintenance and verification.



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

government regulations.



The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective

equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when

handling them in the laboratory.



If the reagents accidentally spill on your skin, wash them off with plenty of water and if

necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off

with plenty of water and immediately go see a doctor.

CAUTION



Improper maintenance may damage the analyzer. Maintain the analyzer strictly as

instructed by the service manual and inspect the analyzer carefully after the

maintenance.



For problems not mentioned in the service manual, contact ZYBIO customer service

department for maintenance advice.



Toprevent 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 ofESD

damage with a procedure, then do that procedure at an ESD workstation, or wear an

antistatic wrist strap.



The operator is required to follow the instructions below this symbol.



The instructions will emphasize important information or information that requires particular

attention of the operator.

1.5

When you see...

Symbols used in this service manual:

Symbol

Meaning

The operator is required to follow the instructions below

this symbol. Failure to do so may place the operator at a

potential risk of biohazard.

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