Zybio Z3 User manual

Z3
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:
[e-mail]
Tel:
[phone]
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
3.4 Dilution..........................................................................................................................17
3.5 WBC Measurement.........................................................................................................17
3.5.1 Measurement Principle:......................................................................................17
3.5.2 WBC-Related Parameters...................................................................................18
3.5.3 HGB Measurement ............................................................................................20
3.6 RBC/PLT Measurement...................................................................................................20
3.6.1 Impedance Method.............................................................................................20
3.6.2 RBC-Related Parameters....................................................................................21
3.6.3 PLT-Related Parameters......................................................................................22
3.7 Wash..............................................................................................................................23
4.Software and Interface ..................................................................................................................24
4.1. Login ................................................................................................................................24
4.2 Review...........................................................................................................................24
4.2.1 Trend Graph.......................................................................................................24
4.3 Calibration......................................................................................................................25
4.3.1 Calibration Factors.............................................................................................25
4.3.2 Calibration with Calibrator .................................................................................25
4.4 Gain Setup......................................................................................................................27
4.5 Performance ...................................................................................................................28
4.5.1 Background Count.............................................................................................28
4.5.2 Reproducibility..................................................................................................28
4.5.3 Carryover ..........................................................................................................28
4.6 Advanced Toolbox..........................................................................................................28
4.6.1 Export ...............................................................................................................28
4.7 Software Update .............................................................................................................29
4.8 Status Indicator ...............................................................................................................30
4.9 Buzzer............................................................................................................................30
5Fluidics ........................................................................................................................................31
5.1 Introduction to Fluidic Parts.............................................................................................31
5.1.1 Valves...............................................................................................................31
5.1.2 LVM fluidic valve..............................................................................................32
5.1.3 Linkage Syringe Device .....................................................................................32
5.1.4 Vacuum pump....................................................................................................33
5.1.5 Air pump...........................................................................................................33
5.1.6 Sample probe.....................................................................................................34
5.1.7 Probe wipes .......................................................................................................34
5.1.8 Baths.................................................................................................................35
5.2 Sample Dilution Flow Chart............................................................................................36
5.2.1 Whole Blood Mode............................................................................................36
5.2.2 Pre-dilute Mode.................................................................................................36
5.3 Introduction to Fluidic Channels ......................................................................................37
5.3.1 WBC/HGB channel............................................................................................37
5.3.2 RBC/PLT channel ..............................................................................................37
5.4 Sample Volume...............................................................................................................37

Table of Contents
5.5 Introduction to Sequences................................................................................................38
5.5.1 Fluidic diagram..................................................................................................38
5.5.2 Sample Aspiration..............................................................................................38
5.5.3 WBC Chamber Drain.........................................................................................39
5.5.4 Sample Probe Outside Wash...............................................................................39
5.5.5 WBC Diluent Adding.........................................................................................40
5.5.6 Add Sample with Diluent ...................................................................................40
5.5.7 Mix WBC and RBC Chamber.............................................................................41
5.5.8 Aspirate Lyse.....................................................................................................41
5.5.9 WBC Chamber Add Lyse with Diluent ...............................................................42
5.5.10 Counting Blood Cell ..........................................................................................42
5.5.11 Probe Cleanser Maintenance (Shutdown Sequence) .............................................43
5.5.12 Cleaning Procedure during Startup......................................................................43
5.5.13 Standby.............................................................................................................43
6Hardware System..........................................................................................................................44
6.1 Hardware System Function Block Diagram ......................................................................44
6.2 Electrical Connection Diagram ........................................................................................45
6.3 System Problem..............................................................................................................45
6.4 Main Control Board........................................................................................................47
6.4.1 Introduction.......................................................................................................47
6.4.2 Components.......................................................................................................47
6.4.3 Debugging and Troubleshooting .........................................................................50
6.4.4 Troubleshooting for Main Control Board.............................................................51
6.5 Motor drive board...........................................................................................................55
6.5.1 Introduction.......................................................................................................55
6.5.2 Components.......................................................................................................55
6.5.3 Debugging and Troubleshooting .........................................................................56
6.5.4 Troubleshooting for Motor drive Board...............................................................57
6.6 Power board....................................................................................................................58
6.6.1 Introduction.......................................................................................................58
6.6.2 Power Board Replacing and Wiring ....................................................................59
6.6.3 Power Board Problem ........................................................................................60
6.7 Touch Screen Control Board............................................................................................61
6.7.1 Introduction.......................................................................................................61
6.7.2 Components.......................................................................................................61
6.7.3 TouchScreen Control Board Problem..................................................................61
6.8 Indicator Board...............................................................................................................62
6.8.1 Introduction.......................................................................................................62
6.8.2 Components.......................................................................................................63
6.8.3 Indicator Board problem.....................................................................................63
6.9 Motors, Photocouplers and Micro-switches ......................................................................63
6.9.1 Introduction.......................................................................................................63
6.9.2 Motor and Photocoupler problem........................................................................64
6.10 Liquid Detection Board...................................................................................................65

Table of Contents
6.10.1 Introduction.......................................................................................................65
6.10.2 Components.......................................................................................................65
6.10.3 Liquid detection board problem ..........................................................................65
7Mechanical System.......................................................................................................................66
7.1 Introduction to Mechanical Structure................................................................................66
7.1.1 Front of the Analyzer .........................................................................................66
7.1.2 Front of the Analyzer (front cover open) .............................................................66
7.1.3 Back of the analyzer...........................................................................................67
7.1.4 Left Side of the Analyzer....................................................................................67
7.1.5 Left side of the analyzer (left door open).............................................................68
7.1.6 Right Side of the Analyzer (right door open)........................................................68
7.2 Overview of Assemblies..................................................................................................69
7.2.1 Introduction.......................................................................................................69
7.2.2 Whole Device Explosive view ............................................................................69
7.2.3 Sampling System ...............................................................................................70
7.2.4 Cell counting assembly.......................................................................................70
7.2.5 WBC chamber assembly.....................................................................................71
7.2.6 Power supply assembly ......................................................................................71
7.2.7 Vacuum tank assembly.......................................................................................72
7.2.8 Vacuum pump assembly.....................................................................................72
7.2.9 Air pump...........................................................................................................72
7.2.10 Valve assembly..................................................................................................73
7.2.11 Syringe assembly...............................................................................................73
7.2.12 Front cover assembly .........................................................................................73
8Troubleshooting............................................................................................................................74

1
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
Z3
××
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.

2
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.

3
 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.

4
WARNING
The operator is required to follow the instructions
below this symbol. Failure to do so may cause personal
injury.
CAUTION
The operator is required to follow the instructions below
this symbol. Failure to do so may cause malfunction or
damage of the product or affect the test results.
NOTE
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.
The analyzer system may contain the following symbols:
CAUTION
Ensure the labels are in good condition and not damaged while servicing the analyzer.
When you see…
It means…
CAUTION, CONSULT ACCOMPANYING
DOCUMENTS.
Note: It is recommended that the reader
refers to the accompanying documents
for important safety information.
BIOLOGICAL RISK
WARNING, LASER BEAM
PROTECTIVE EARTH (GROUND)
USB port
Network interface
ALTERNATING CURRENT
FOR IN VITRO DIAGNOSTIC USE

5
Batch code
USE BY (YYYY-MM-DD)
Serial number
DATE OF MANUFACTURE
Pricking danger
Manufacturer
TEMPERATURE LIMITATION
CONSULT INSTRUCTIONS FOR USE
The device fully complies with requirements
of EU IVD Directive 98/79/EC

6
2Product Specifications
2.1 Product Name
Name: Auto Hematology Analyzer
Model: Z3
Appearance:

7
2.2 Physical Specifications
Height
Width
Table 2-1 Dimensions and weight
Z3
Whole device
Z3
Length : 300 mm
Height : 400 mm (rubber feet included)
Depth : 410 mm
Weight
≤20Kg
2.3 Electrical Specifications
Table 2-2 Main unit power supply
Parameter
Value
Voltage
(100V-240V~) ±10%
Input Power
≤200VA
Frequency
50/60±1Hz
 Only fuses of specified specification shall be used.
Fuse Specification: 250 V T6.3 AH
Depth

8
2.4 Environment Requirements
Operating environment, storage environment and running environment:
Table 2-3 Overall environment requirements
Operating Environment
Requirements
Storage Environment
Requirements
Running Environment
Requirements
Ambient
Temperature
15℃～35℃
-10℃～40℃
10℃～40℃
Relative
Humidity
20%～85%
10%～90%
10%～90%
Atmospheric
Pressure
70kPa～106kPa
50kPa～106kPa
70kPa～106kPa
2.5 Product Specifications
2.5.1 Sample mode
Two sample modes are provided: WB (whole blood) mode and PD (pre-diluted) mode.
2.5.2 Throughput
The throughput of Z3 WB/PD is 70 samples/hour.
2.6 Testing Parameters
The analyzer provides quantified results for 21 report parameters (WBC, RBC, PLT, HGB, etc.)
and 3 histograms (WBC, RBC, and PLT). See the table below for details.
Table 2-4 Parameters
Name
Abbreviation
White Blood Cell count
WBC
Lymphocyte number
Lymph#
Mid-sized Cell number
Mid#
Granulocyte number
Gran#
Lymphocyte percentage
Lymph%
Mid-sized Cell percentage
Mid%
Granulocyte percentage
Gran%
Red Blood Cell count
RBC
Hemoglobin concentration
HGB
Mean Corpuscular Volume
MCV
Mean Corpuscular Hemoglobin
MCH

9
Mean Corpuscular Hemoglobin Concentration
MCHC
Red Blood Cell Distribution Width Coefficient of Variation
RDW-CV
Red Blood Cell Distribution Width Standard Deviation
RDW-SD
Hematocrit
HCT
Platelet count
PLT
Mean Platelet Volume
MPV
Platelet Distribution Width
PDW
Plateletcrit
PCT
Platelet Larger Cell Ratio*
P-LCR*
Platelet Larger Cell Count*
P-LCC*
Table 2-5 Histograms
White Blood Cell Histogram
WBC Histogram
Red Blood Cell Histogram
RBC Histogram
Platelet Cell Histogram
PLT Histogram
2.7 Performance Requirements
2.7.1 Background/Blank Count
Background refers to the background count performed automatically by the analyzer during the
startup process; its result shall meet the requirements in the following table.
The blank count requirements apply to both whole blood and pre-dilute modes.
Blank count test method: run diluent on the analyzer consecutively for 3 times, the highest
value among the 3 results shall meet the requirements in the following table.
Table 2-6 Background/blank count requirements
Parameter
Background/blank count requirements
WBC
≤ 0.20×109/ L
RBC
≤ 0.02×1012/ L
HGB
≤1 g/L
HCT
≤ 0.5 %
PLT
≤ 5×109/ L
2.7.2 Carryover
Carryover refers to the transfer of blood cells from high concentration sample to low concentration sample.
Verification method:
Prepare a high concentration sample (centrifuged high value control or special high value linearity
control) which is within the range specified in Table 2-6, mix and then test it consecutively for 3
times, and the test results are i1, i2, and i3; prepare a low concentration sample (diluted low value

10
control, dilution ratio: 1:10) which is within the range specified in Table 2-8, test it consecutively for
3 times, and the test results are j1, j2, and j3. Calculate the carryover according to the following
equation, and the result shall meet the requirements in Table 2-7.
Table 2-7 Carryover Requirements
Parameter
Carryover
WBC
≤0.5％
RBC
≤0.5％
HGB
≤0.5%
PLT
≤1.0%
Table 2-8 Sample Concentration Range of Carryover Test
Parameter
Unit
High concentration range
Low concentration range
WBC
×109/L
> 90.00
< 3.00
RBC
×1012/L
> 6.20
< 1.50
HGB
g/L
> 220
< 50
PLT
×109/L
> 900
< 30
2.7.3 Repeatability
Test a sample which meets repeatability requirement on the analyzer consecutively for 10 times,
calculate the CV(%) and absolute deviation (d) of each parameter, and the results shall meet the
requirements in the following table.
In the equation:
s
----standard deviation of sample test results;
x----mean value of sample testresults;
xi ----actual test result of the sample;
d ----absolute deviation of the sample test results.

11
Table 2-9 Whole Blood Repeatability Requirements
Parameter
Condition
Whole Blood Repeatability
(CV/absolute deviation d)
Pre-dilute Repeatability
(CV/absolute deviation d)
WBC
7.0～15.00×109/ L
≤2.0％
≤4.0％
4.0 ~ 6.9×109/ L
≤ 3.5
RBC
3.50 ~ 6.50×1012 / L
≤1.5%
≤2.0%
HGB
100 ~ 180 g/L
≤1.5%
≤2.0%
MCV
70.0～110.0 fL
≤1.0%
≤1.5%
PLT
100 ~ 149×109/ L
≤5.0%
≤8.0%
150 ~ 500×109/ L
≤4.0%
HCT
30～50%
/
≤ 2.5
MPV
-
≤4.0%
≤5.0%
2.7.4 Linearity
Linearity was determined by running diluted samples. Samples of different concentrations were
tested in both whole blood and pre-dilute modes; the slope and intercept were calculated per the
linear regression equation, and then the deviation between the theoretical value and test result was
obtained, which shall meet the requirements in the following table.
Table 2-10 Linearity Requirements
Para
meter
Linearity Range
Deviation Range
(Whole Blood)
Deviation Range
(Pre-dilute)
WBC
0.0～100.0×109/L
±0.30×109/L or 5％
±0.50×109/L or 5％
100.1～200.0×109/L
±9％
±18%
RBC
0.0～8.00×1012/L
±0.05 ×1012/L or
±5％
±0.05 ×1012/L or
±5％
HGB
0～280 g/L
±2g/L or ±2％
±2g/L or ±3％
PLT
0～1000×109/L
±10×109/L or ±10%
±10×109/L or ±10%
1001 ~ 4000×109/L
±12%
±20%
HCT
0~67%
±4% (HCT value) or
±6% (deviation
percent)
/
Note: The linearity ranges above are expressed in both absolute deviation and deviation percent, meeting
either of the ranges are OK.

12
2.8 Display Range
Table 2-11 Display Range
Parameter
Display Range
WBC
0.00×109/L～999.99×109/L
RBC
0.00×1012/L～18.00×1012/L
HGB
0 g/L～300g/L
PLT
0×109/L～9999×109/L
HCT
0%~80%
2.9 Product Description
Z3 Auto Hematology Analyzer is mainly composed of the analysis module, information management
module, result output module and accessories.

The analyzer is heavy. Do not try to carry it by oneself, or serious injury may be
caused. It requires at least two persons to transport the analyzer. Use necessary
tools if possible.
Figure 2-1 Front of the analyzer
1 ---- Display scree 2 ---- Sample probe
3 ---- [Aspiration] Key 4 ---- Power/status indicator

13
Figure 2-2 Back of the analyzer
1 --- Diluent inlet 2 --- Waste outlet
3 --- Waste sensor connector 4 --- Power input socket
5 --- Network interface 6 --- USB interface
Figure 2-3 Left side of the analyzer
1 --- Built-in recorder 2 --- Locker
3 --- Side door
2.9.1 Main unit
The main unit performs sample analysis and data processing. It is the main part of the instrument.
2.9.2 Power/status indicator
The power/status indicator tells you about the status of the analyzer including ready, running,
error, standby and on/off, etc.