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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.
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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.
Table of Contents Contents 1 Using This Manual..........................1 Overview ..........................1 Who Should Read This Manual..................1 Conventions Used in This Manual..................1 Safety Information ......................2 When you see........................3 2 Product Specifications ........................6 Product Name ........................6 Physical Specifications ......................7 Electrical Specifications ....................7 Environment Requirements....................8 Product Specifications .......................8 2.5.1 Sample mode .......................8...
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Table of Contents 6.10.1 Introduction ....................... 65 6.10.2 Components....................... 65 6.10.3 Liquid detection board problem ................65 7 Mechanical System ........................66 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 ...................
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.
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. Read the statement below the symbol. The statement is alerting you WARNING to an operating hazard that can cause personnel injury.
For problems not mentioned in the service manual, contact ZYBIO customer service department for maintenance advice. To prevent personal injury or damage to equipment components, remove metal jewelry before maintaining or servicing electronic components of the equipment.
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The operator is required to follow the instructions WARNING below this symbol. Failure to do so may cause personal injury. The operator is required to follow the instructions below this symbol. Failure to do so may cause malfunction or CAUTION damage of the product or affect the test results.
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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...
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).
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 Platelet count Mean Platelet Volume Platelet Distribution Width Plateletcrit Platelet Larger Cell Ratio* P-LCR* Platelet Larger Cell Count* P-LCC* Table 2-5 Histograms White Blood Cell Histogram...
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...
/L~9999×10 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.
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...
2.9.3 Power input socket The power input socket is at the back of the main unit. It is used to turn on or off the analyzer. CAUTION Once you turn on/off the analyzer, do not operate the power switch again in 10 seconds, or it may cause damage to the analyzer.
Instruction for Use of each product. All references related to the controls and calibrators in this manual refer to the "controls" and "calibrators" ZYBIO specifically formulated for Z3 by ZYBIO. 2.12 Information Storage Capacity Table 2-12 Data storage requirements...
3 System Principles 3.1 Introduction The analyzer uses the electrical impedance method to determine the count and size distribution of RBC, WBC and PLT, and uses the colorimetric method to determine HGB. Based on the above data, the analyzer calculates other parameters. 3.2 Analyzer Workflow We have defined the whole operation workflow of the analyzer by its major functions: reagent system, sample loading and distribution, sample preparation, sample measurement,...
System Principles 3.3 Aspiration If you want to analyze a whole blood sample, present the sample to the analyzer directly, and the analyzer will aspirate 10μL of the whole blood sample. If you want to analyze a capillary blood sample under the pre-dilute mode, you should first manually dilute the sample (20μL capillary sample needs to be diluted by 0.58 mL of diluent to form a 1:30 dilution), and then present the pre-diluted sample to the analyzer, which will aspirate 183uL of the sample.
System Principles Figure 3-1 Metering diagram 3.5.2 WBC-Related Parameters White Blood Cell count WBC (10 /L) is the number of leukocytes measured directly by counting the leukocytes passing through the aperture. Sometimes there are nucleated red blood cells (NRBC) presenting in the sample. While the lyse will not be able to break their nuclear membrane, these NRBCs will also be counted as WBCs.
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System Principles In the formulae: PL indicates the number of cells falling in the lymphocyte region, PM the number of cells falling in the mid-sized cell region, and PG the number of cells falling in the granulocyte region. All three parameters are presented in 10 When the three percentages are obtained, the analyzer automatically proceeds to calculate the lymphocyte number (Lym#), mid-sized cell number (Mid#) and granulocyte number (Gran#) by below formulae, all parameters expressed in 10...
System Principles After each analysis cycle, you can either check the WBC histogram in the analysis result area on the "Sample Analysis" screen or review the histogram on the "Review" screen. 3.5.3 HGB Measurement The HGB is determined by the colorimetric method. The diluted sample is delivered to the WBC count bath where it is bubble mixed with a certain amount of lyse, which breaks red blood cells, and converts hemoglobin to a hemoglobin complex.
System Principles Figure 3-2 Metering diagram 3.6.2 RBC-Related Parameters Red Blood Cell count RBC (10 /L) is the number of erythrocytes measured directly by counting the erythrocytes passing through the aperture. Mean Corpuscular Volume The analyzer calculates the mean cell volume (MCV, in fL) based on the RBC histogram. ...
System Principles RDW-CV Red Blood Cell Distribution Width - Coefficient of Variation (RDW-CV) is derived based on RBC histogram. It is expressed in %, and indicates the variation level of RBC size distribution. RDW-SD Red blood cells distribution width - standard deviation (RDW-SD, in fL) measures the width of the 20% level (with the peak taken as 100%) on the RBC histogram, as shown in Figure 3-3.
System Principles Platelet distribution width (PDW) is derived from the platelet histogram, and is reported as 10 geometric standard deviation (10 GSD). he analyzer calculates the PCT (%) as follows: where the PLT is expressed in 10 /L and the MPV in ...
Software and Interface 4. Software and Interface 4.1. Login User ID and Password for Service Level Access User ID: Service Password: Service123 4.2 Review 4.2.1 Trend Graph Figure 4-1 Trend graph screen When the mean value of the selected parameter results are calculated, then the ordinates corresponding to the mean value point, the upper limit point and the lower limit point are Mean, Mean + Mean * 10%, and Mean –...
Software and Interface Figure 4-2 4.3 Calibration 4.3.1 Calibration Factors Calibration is performed to ensure the analyzer may deliver accurate sample analysis results. During the calibration process, a calibrator factor will be calculated. This factor will be used to multiply with the analysis results to output the final results.
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Software and Interface Figure 4-3 Calibration at Service Access Level When performing calibration with calibrator at service access level, the analyzer calculates all factory calibration factors automatically. You need to run calibrator at least 5 times to calculate and save calibration factors.
Software and Interface 4.4 Gain Setup You can set up the gain for HGB on the "Gain Setup" screen. Gains for other parameters are obtained by gain calibration and cannot be edited. Figure 4-4 Gain Setup Adjust the HGB gain by clicking + or – button to change HGB gain value to get HGB blank value around 4.5±0.1V, then save HGB gain.
Software and Interface 4.5 Performance 4.5.1 Background Count Press the [Aspirate] key to start background count. You do not need to run actual samples. The background is acceptable only when all the result boxes display "pass" on the background count screen.
Software and Interface 4.7 Software Update Prepare the USB for update Unzip the file named "update.tar.gz", and then copy the "update" directory in the unzipped 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.
4.8 Status Indicator 4.9 Buzzer When there is any error, the buzzer gives out an alarm sound. Tap the touch screen to silent the buzzer; or when the errors are removed the alarm sound will stop automatically. The buzzer also sounds in other ways indicating different system status.
5 Fluidics 5.1 Introduction to Fluidic Parts 5.1.1 Valves Symbol: 2-way valve 3-way valve Appearance: 2-way valve 3-way valve Function: 2-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;...
5.1.2 LVM fluidic valve Symbol: Appearance: 3-way LVM fluidic valve Function: 3-way valve: to switch among passages. When power off, the public end (COM) and the NO (normally open) end are connected; when power on, the public end and the NC (normally closed) end are connected.
Table 5-1 Syringe specifications and functions Name Specification Function Full range is Aspirate and dispense blood sample of precise volume, and Low volume syringe 250ul perform second aspiration. Dispense fixed volume of diluent to the WBC and RBC Full range is bathes, dispense liquid to the probe wipes, and supports High volume syringe 10ml...
Appearance: Function: to provide pressure and generate bubbles for WBC and RBC chamber mixing. 5.1.6 Sample probe Symbol: Appearance: Function: provides a rigid, blood corrosion-resistant cavity for aspiration and dispensing of sample and probe cleanser. 5.1.7 Probe wipes ...
Appearance: Function: provide a cavity where the interior and exterior walls of open-vial probe or piercing probe can be cleaned by liquid flow; and the waste thus produced is also collected here. 5.1.8 Baths WBC bath: consists of front bath, back bath and an aperture. It is where the WBC sample is mixed for analysis;...
5.3 Introduction to Fluidic Channels 5.3.1 WBC/HGB channel Reagent used: 1) cyanide-free lyse (break out RBCs and PLTs and 3-differentiate WBCs based on cell size); 2) diluent (used for cleaning, and providing appropriate environment for reaction and measurement) Measurement principle: impedance method (for WBC count);...
5.5.5 WBC Diluent Adding Sample and reagent syringe push diluent goes through SV1-SV6-SV7 to WBC chamber. Fig. 5-7 WBC Diluent Adding 5.5.6 Add Sample with Diluent Sample and reagent syringe push sample with diluent goes through SV1-SV6-SV2 to WBC or RBC chamber.
5.5.7 Mix WBC and RBC Chamber Air pump push bubble to WBC and RBC chamber by going through SV9 and SV8. Fig. 5-9 Mix WBC and RBC Chamber 5.5.8 Aspirate Lyse Sample and reagent syringe aspirate lyse by going through SV1-SV6-SV7. Fig.
5.5.9 WBC Chamber Add Lyse with Diluent Sample and reagent syringe push lyse by going through SV1-SV6-SV7 to WBC chamber. Fig. 5-11 WBC Chamber Add Lyse with Diluent Counting Blood Cell 5.5.10 Vacuum tank aspirate sample by going through chamber’s aperture and SV4. Fig.
5.5.11 Probe Cleanser Maintenance (Shutdown Sequence) The probe cleanser maintenance during the shutdown process involves the following parts: the front and back baths of WBC and RBC baths, back bath tubing, sample probe as well as sampling tubing. The analyzer will perform "enhanced" probe cleanser maintenance after 1000 analyses. Compared with normal probe cleanser maintenance, the enhanced process uses a longer probe cleanser soak time (1 minute longer than normal maintenance).
Hardware System The hardware system not only consists of power board, main control board, indicator board, touch screen control board and liquid detection board, but also the electrified drives and components (e.g. motors, valves, pumps, sensors, screens, and power filters), as well as the cables connecting different boards or connecting boards and components.
printer, keyboard, and barcode scanner) and Ethernet interface. Besides, peripheral interfaces also include those to the working status indicator and the [Aspirate] key. 6.2 Electrical Connection Diagram The electrical connection of the analyzer is shown as below: Figure 6-2 Electrical Connection 6.3 System Problem Hardware system errors mainly include board errors, cable errors and component errors.
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Figure 6-3 Troubleshooting for power supply problem Figure 6-4 Power Filter Figure 6-5 shows the troubleshooting flowchart for power-on protection.
Figure 6-5 Troubleshooting for power-on protection problem 6.4 Main Control Board 6.4.1 Introduction The main control board consists of analog module, digital module and power drive module; among which, the analog module conditions and amplifies the signals from the impedance channel and HGB channel as well as other analog signals like monitoring voltages, and converts them into digital signals through the A/D converter.
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Data processing Peripheral interface enabling Control interface extending Figure 6-6 Main control board structure Introduction Drive module Consists of motor drive and power component drive. A/D conversion Converts analog signals to digital signals which can be processed by FPGA or CPU. ...
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Figure 6-7Sockets on the main control board Definition of sockets The main control board has 18 sockets. See Table 6-1 for the socket functions; see Figure 6-4 for their positions. Table 6-1 Socket functions on the main control board Sockets Function PIN function description Description...
PIN5: GND backlight port LCD data cable port Touch screen port HGB signal cable PIN1: LED power + port PIN2: LED power- PIN3,4: AGND PIN5: HGB signal input RBC signal cable PIN1,3: AGND port PIN2: RBC signal input WBC signal cable PIN1,3: AGND port PIN2: WBC signal input...
TP10 12V power input test voltage is not 12V: main board is defective or power point supply is defective 5V power input test voltage is not 5V: main board is defective or power point supply is defective TP23 Digital earth TP18 3.3V power input test voltage is not 3.3V: main board is defective...
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When you have confirmed all the cables are properly connected, all the input power and indicators work normally, follow the instruction in Table 6-4 for troubleshooting. Table 6-4 Troubleshooting for main control board Error Troubleshooting Solution 1. Check whether the cable connecting the main Unplug and reconnect screen control board and the backlight socket, and the cable...
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is removed. If not, proceed to next step. connecting the main control board and the LCD screen. 2. Replace the cable connecting the main control Replace cable board and the backlight and the cable connecting the connecting the main main control board and the LCD screen. If the error control board and the still exists, proceed to next step.
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connection is OK. If the network connection still fails, proceed to next step. 2. When the analyzer is powered on and connected Reconnect or replace to PC, but network port LEDs do not light on, then the the network cable. network connection is bad or the network cable is damaged.
key is see whether there is liquid split on the switch. If yes, pressed clean the liquid and re-install the board. 6.5 Motor drive board 6.5.1 Introduction The motor drive board consists of power drive module which is controlled by ARM to drive motors valves and pumps.
Figure 6-9 Sockets on the motor drive board Definition of sockets The motor drive board has 7 sockets. See Table 6-5 for the socket functions; see Figure 6-9 for their positions. Table 6-5 Socket functions on the motor drive board Sockets Function PIN function description...
LED indicator functions The functions of the LED indicators on the main control board are defined in Table 6-6. Table 6-6 Functions of LED indicators on the motor drive board Possible causes when the LED does Indicators Functions not light DC circuit LED8 Power supply defective,...
problem. Also many errors need to be detected by software. Check the following items before troubleshooting the main control board: Check whether the cables connecting to the motor drive board get loose or insecure. Check whether the position No. marked on the cable correspond to the sockets there are connected to;...
Figure 6-10 Interface connections on the power board The functions of the interfaces are listed below: Table 6-9 AC input connection cable Definition AC-L Live line terminal to AC AC-N Zero line terminal to AC Table 6-10 Outlet sockets Name Description V3:5V 12V, 24V...
Take out the power assembly from the main unit case; Open the power unit, remove the screws on the power board, and take out the board from the power unit. WARNING Wear an antistatic wrist strap while removing the board; ...
6.7 Touch Screen Control Board 6.7.1 Introduction As the interface between the touch screen and the main control board, the touch screen control board transfers the touch actions from the users to recognizable signals by main control board. You may need to make some adjustment to the touch screen control board during use.
The cable The cursor only 1. 1. Check whether is any crack on the touch screen. If yes, connecting the moves in replace the touch screen. touch screen horizontal or 2. 2. Reconnect the cable connecting the touch screen control board and the touch screen vertical control board and the touch screen.
6.8.2 Components The indicator board consists of a three color indicator (red, yellow and green) with its control circuit. You do not need to make adjustment to the indicator board during use. 6.8.3 Indicator Board problem Table 6-12 Troubleshooting for indicator problem Troubleshooting Problem type Problem...
Figure 6-15 Photocouplers illustrations 6.9.2 Motor and Photocoupler problem Table 6-13 Troubleshooting for motors, photocouplers and micro-switches Problem type Problem Troubleshooting description Motors The motor does 1. 1. Check whether the problem is caused by main control not rotate. board problem (whether LCD may display properly, if there is any power-related alarms);...
6.10 Liquid Detection Board 6.10.1 Introduction The liquid detection board detects whether there is liquid in the tubes by monitoring the index of refraction. Figure 6-16 Liquid detection board 6.10.2 Components The most important components of the board are the photocouplers. You can use a piece of paper to block the photocoupler and check whether the board is working properly.
This section demonstrates the positions of major serviceable components in the analyzer so our service people may find these component quickly to remove or replace them. Figures, pictures and drawings in this manual are prepared based on Z3. 7.1.1 Front of the Analyzer...
7.1.3 Back of the analyzer Figure 7-3 Back of the analyzer 1 ---- Diluent inlet 2 ---- Waste outlet 3 ---- Waste sensor connector 4 ---- Power input socket 5 ---- Network interface 6 ---- USB interface 7.1.4 Left Side of the Analyzer Figure 7-4 Left side of the analyzer 1 ---- Recorder 2 ---- Side door...
7.1.5 Left side of the analyzer (left door open) Figure 7-5 Left side of the analyzer (left door open) 1 ---- Motor Drive Board 2 ---- Main control board 3 ----Shielding Box 7.1.6 Right Side of the Analyzer (right door open) Figure 7-6 Right side of the analyzer (right door open) 1 --- Sampling track 2 --- Vacuum tank...
7.2 Overview of Assemblies 7.2.1 Introduction This section displays the explosive views of various assemblies of the analyzer, so our service people may find the component quickly to remove or replace them. NOTE The material IDs listed in the BOM shall only be used by service people to find the material numbers of maintenance spare parts.
7.2.3 Sampling System Figure 7-8 Sampling system 1 --- Sample system vertical motor 2 --- Vertical motor belt 3 --- Sampling system horizontal sliding rail Figure 7-9 Sampling system 1 --- Sample system vertical motor 2 --- Wash wiper 3 --- Vertical motor belt 7.2.4 Cell counting assembly...
8 Troubleshooting Error Code Troubleshooting Solution Abnormal Reconnect communication cable or 0x01000001 Communication error. communication replace PCBA board. Voltage Abnormal 0x01000002 AD out of range [2.44-2.55]V 1. Check whether the button cell of the main control board is installed; 2. Replace with a new button cell, and set up the date and time in the setup The time indicated by the system System Time Error...
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Clog 0x01000901 Aperture signal does not stable Unclog and test blank Aperture Voltage Maintenance chamber or replace 0x01000902 Aperture voltage is lower than 14V Abnormal main control board. Impedance Signal 1.Signal interference 0x01000903 Interference 2.PLT noise signal more than 10% Clog 0x01000904 Aperture signal does not stable...
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