Mindray BA-88A Service Manual
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Mindray BA-88A Service Manual

Semi-auto chemistry analyzer
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BA-88A Semi-auto Chemistry Analyzer

Service Manual

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Summary of Contents for Mindray BA-88A

  • Page 1: Service Manual

    BA-88A Semi-auto Chemistry Analyzer Service Manual...
  • Page 3 This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties.
  • Page 4 FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
  • Page 5 Company Contact Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, ShenZhen518057, P.R. China Tel: +86 755 26582479 26582888 Fax: +86 755 26582934 26582500 EC Representative Shanghai International Holding Corp. GmbH...
  • Page 7 This manual is geared for service personnel authorized by Mindray. What Can You Find in This Manual This manual covers principles, installation procedures, theories, maintenance and troubleshooting guidelines of the BA-88A. Please service the system strictly as instructed by this manual. Conventions Used in This Manual This manual uses the following typographical conventions to clarify meanings in the text.
  • Page 8 Date of Manufacture Manufacturer CE marking. The device is fully in conformity with the Council Directive Concerning In Vitro Diagnostic Medical Devices 98/79/EC. Authorized Representative European Community The following definition of the WEEE label applies to EU member states only: The use of this symbol indicates that this product should not be treated as household waste.
  • Page 9 Safety Precautions Observe theses safety precautions when using the system. Ignoring any of the precautions may lead to personal injury or equipment damage. WARNING If the instrument is used in a manner not specified by our company, the protection provided by the system may be impaired. Preventing Electric Shock Please observe the following instructions to prevent electric shock.
  • Page 10 Preventing Personal Injury Caused by Photometer Lamp Please observe the following instructions to prevent personal injury caused by photometer lamp. WARNING Light sent by the photometer lamp may hurt your eyes. Do not stare into the lamp when the system is in operation. If you want to replace the photometer lamp, first switch off the Main Power and then wait at least 15 minutes for the lamp to cool down before touching it.
  • Page 11 Treating Waste Liquids Please observe the following instructions to prevent environmental pollution and personal injury caused by waste. BIOHAZARD Some substances in reagent, control, enhanced wash solution and waste are subject to regulations of contamination and disposal. Dispose of them in accordance with your local or national guidelines for biohazard waste disposal and consult the manufacturer or distributor of the reagents for details.

  • Page 12: Intended Use

    The system is an analyzer designed for in vitro quantitative determination of clinical chemistries in serum, plasma, urine and CSF samples. Please consult Mindray first if you want to use the system for other purposes. To draw a clinical conclusion, please also refer to the patient’s clinical symptoms and other test results.
  • Page 13 Preventing Interference by Electromagnetic Noise CAUTION Electromagnetic noise may interfere with operations of the system. Do not install devices generating excessive electromagnetic noise around the system. The electromagnetic environment should be evaluated prior to operation of the device. Do not use such devices as mobile phones or radio transmitters in the room housing the system.
  • Page 14 Maintaining the System CAUTION Maintain the system strictly as instructed by this manual. Inappropriate maintenance may lead to unreliable results, or even equipment damage and personal injury. To wipe off dust from the system surface, use a soft, clean and wet (not too wet) cloth, soaked with mild soap solution if necessary, to clean the surface.
  • Page 15 Samples CAUTION Use samples that are completely free of insoluble substances like fibrin, or suspended matter; otherwise the probe may be blocked. Medicines, anticoagulants or preservative in the samples may lead to unreliable results. Hemolysis, icterus or lipemia in the samples may lead to unreliable test results, so a sample blank is recommended.
  • Page 16 External Equipment WARNING External equipment connected to the analogue and digital interfaces must be complied with the relevant Safety and EMC standards (e.g., IEC 60950 Safety of Information Technology Equipment Standard and CISPR 22 EMC of Information Technology Equipment Standard (CLASS B)). Any person, who connects additional equipment to the signal input or output ports and configures an IVD system, is responsible for ensuring that the system work normally and complies with the safety and EMC...

  • Page 17: Table Of Contents

    Contents Contents........................I System Specifications ................1-1 System specifications..................... 1-1 Parameters ......................1-1 Instrument Configuration ..................1-2 Overview........................ 1-2 System Installation..................2-1 Basic........................2-1 Installation Procedures ................... 2-2 System Description ................... 3-1 Operating Procedures .................... 3-1 Component Structure and Functions............... 3-2 3.2.1 Photometer Assembly ................
  • Page 18 Analogue Board ..................... 4-7 LCD&Touchscreen Board ..................4-8 Power board ......................4-9 4.8.1 Overview ....................4-9 4.8.2 The Basic Feature of the Power Module............. 4-9 LCD Background Adjustment ................4-10 4.10 Connection of the Hardware System ..............4-11 4.10.1 Definition of the CPU Board + CPU Extension Board Interface ....4-11 4.10.2 Analogue Board Interface ..............

  • Page 19: System Specifications

    System Specifications System specifications Dimension: ≤420mm ×350mm ×158mm(L×W×H) Weight: ≤7Kg Power supply: 100-240V～, 50/60Hz; Power consumption: maximum 140VA; Operating methods: touchscreen, USB key board and mouse. Parameters Reaction type: Endpoint, Kinetics, Fixed-time, Absorbance; Analyzing methods: single/double- wavelength; Clinical chemistries, immunoassays, TDM (Therapeutic Drug Monitoring) Aspiration volume: 200μl-9000μl ;...

  • Page 20: Instrument Configuration

    Instrument Configuration Wavelengths: 6 wavelengths (available): 340nm, 405nm, 510nm, 546nm, 578nm and 630nm.2 wavelengths (optional): 450nm and 670nm. Reaction container: flow cell or cuvette. Printing: thermal recorder. Overview Colorimetric system: The colorimetric analysis is realized through the combination of optical collimating, mono-color filter, mechanical parts and software, hardware module.

  • Page 21: System Installation

    System Installation Basic Make sure the installation site of the hospital meet the system installation requirements on space, power supply and environment. Please refer to the operator’s manual for details. If data management software or test and maintaenance software is used on PC, please make sure the configuration of the PC meet the system requirement.

  • Page 22: Installation Procedures

    Databse: SqlServer 2005 Express Network communication: 10/100M 10/100M Communication interface: RS-232C Hard disk ( the disk on which the software is installed): 10G Printer (connected with PC) Installation Procedures When you receive the system, carefully inspect the package. After opening the package, check the delivered goods against the packing list.

  • Page 23: System Description

    System Description Operating Procedures The typical operating procedure of BA-88A is shown as follows: Figure 3-1 Operating procedure Other tests All the tests Lamp stabilization Reaction finished Temperature stabilization Procedures: Empty the waste. Connect the waste tubing to the waste container. Prepare the samples, reagents and distilled water;...

  • Page 24: Component Structure And Functions

    Component Structure and Functions 3.2.1 Photometer Assembly 3.2.1.1 Introduction Photometer assembly is the core of BA-88A, integrating optical system, temperature control system and photoelectrical collection system. The photometer assembly is the key for reliability of the system. Photometer assembly includes lamp assembly, lamp base assembly, flow cell assembly and other components, which are used to position and install the optical components, thermal components and analogue board.

  • Page 25: Lamp Assembly

    Maintenance of the system, except for replacing the assemblies or components other than lamp assemblies will involve the assembly and disassembly of the photometer assembly as a whole. Please pay attention to the following: When disassembling the instrument, do not drag the cable with excessive force. If necessary, you can disconnect the connection of some cables in advance.
  • Page 26 The replacement of lamp assembly is shown in the following picture. Figure 3-4 Procedure for lamp replacement Components relevant to lamp replacement are shown in the following figure. For more details please refer to 5.3.3. 3 System Description...

  • Page 27: Lamp Base Assembly

    Figure 3-5 Lamp assembly structure WARNING If you want to replace the lamp, first switch off the power and then wait at least 15 minutes for the lamp to cool down before touching it. Do not touch the lamp before it cools down, or you may get burned. NOTE When replacing the lamp assembly, do not touch the surface of the bulb to avoid contamination.
  • Page 28 3.2.3.2 Components and Structure The assembly is composed of lamp base, filter wheel, step motor and etc. The structure is shown as the following figure. Figure 3-6 Lamp base assembly structure 3.2.3.3 Assembly and Disassembly of the Lamp Base Assembly Lamp base assembly is fixed on the instrument base by 4 M4 socket head screws and positioned by 2φ3 pins.
  • Page 29 surface of the lamp base. If obvious blow-up is found, skewed installation of the lens might be the cause and the readjustment might be needed. When disassembling, if it is not necessary to replace the motor, filter wheel or sensor stop plate, we recommend you to keep the connection between the motor and the filter wheel, thus the installing procedure would be simplified;...
  • Page 30 After completing the serial port setting, click Enable Para. Modification on the screen. Select the tab Photoele. And Fluid and then select Filter wheel home position to enter the following screen. Figure 3-8 Adjusting home position of the filter wheel It will take 3 minutes to complete the test.

  • Page 31: Flow Cell Base Assembly

    NOTE Wear clean cotton gloves, when replacing the filter or lens. If contaminant is found on the surface of the filter or lens, clean it with ethanol. NOTE The assembly or disassembly of the filter wheel, motor or home position sensor should be followed with home position deviation adjustment.
  • Page 32 Figure 3-10 Flow cell assembly structure 3.2.4.3 Assembly and Disassembly of the Flow Cell Base Assembly Flow cell assembly is fixed on the instrument base by 4 M4 socket head screws and positioned by 2φ3 pins. When maintaining the components on the side of analogue board and air duct, it is not necessary to dismount the flow cell base assembly and maintenance can be done on the dismounted photometer assembly.
  • Page 33 When replacing the optical components, take care to protect the components. Do not touch the surface of the optical elements with bare hand. Wear antistatic gloves to dismount and mount the analogue board; Do not drag the cable with excessive force. If necessary, you can disconnect the connection of some cables in advance.

  • Page 34: Base Plate Assembly

    NOTE If either of the temperature sensor or analogue board is damaged, both of the two should be replaced by one assembly at the same time. And the replacement should be followed with temperature paremter configuration. During configuration, modifying parameters other than temperature parameters should not be allowed.

  • Page 35: Enclosure Assembly

    refrigeration plate, lamp cable and the connection cable of analogue board. If necessary, you can disconnect the connection of some cables in advance. Replacement of the peristaltic pump should be followed with flow volume calibration (this is not for system configured with cuvette). Please refer to the operator’s manual for details.
  • Page 36 Cover Recorder Aspirate button movement lamp switch replacement window Hole for holding flow cell temporarily Enclosure fixing screw Aspirate button hole Enclosure Touchscreen Touch screen supporting board 3.2.6.3 Assembly and Disassembly of the Enclosure Assembly The enclosure assembly is fixed by 11 screws which are connected to the base plate. Of the 11 screws, 3 are located at the back of the system and the remaining which can be dismounted directly are located under the enclosure.
  • Page 37 Figure 3-14 LCD/touchscreen cable blue face Touchscreen The metal face The metal face should face FPC cable should face should face outward outward outward 3 System Description 3-15...

  • Page 39: Hardware

    Please wear the glove to protect the circuit boards from ESD or release the charge first when you detach the circuit boards. Introduction of the Modules The hardware system of the BA-88A is divided into the following modules or boards: Main unit: CPU board, CPU extension board; Data collection board: analogue board;...

  • Page 40: Cpu Board

    Figure 4-1 The structure of hardware system CPU Board CPU board which is the minimum structure system of CPU system uses 32 digit chip microcomputer as its core. CPU board and CPU extension board make up of the main module. The CPU communicates with the CPU extension board via CPU external interface in multiple-buses communication mode.

  • Page 41: Clock Module

    4.4.3 Clock Module The real time clock circuit which is composed of real time clock and battery, is to realize the function of real time clock on CPU board. 4.4.4 Interface Module CPU communicates with the CPU extension board via various bus interfaces on CPU board.

  • Page 42: Led Indicator

    Figure 4-2 Structure of the CPU extension board 4.5.2 LED Indicator D3: ＋+12V power indicator D6: ＋+24V power indicator D7: ＋+5.0V power indicator D17: ＋3.3V power indicator 4.5.3 USB Functions USB controller is configured on the CPU extension board which communicates with the CPU via bus and realizes the USB communication function via USB interface.

  • Page 43: Lcd&Touchscreen Driver Control

    Figure 4-4 Structure of USB functions 4.5.4 LCD&Touchscreen Driver Control CPU realizes the functions of LCD drive control, reading touch screen data, transforming data transfer protocol. Figure 4-5 Graph of LCD/touchscreen drive control 4.5.5 Serial Port Communication The COM0 of CPU board uses RS232 level translator to translate the level, realizing the serial port communication with PC.

  • Page 44: Driver Of The Step Motor

    4.5.6 Driver of the Step Motor Figure 4-7 Graph of the step motor driver The control module of the CPU extension board (including: MCU and FPGA) outputs motor control signal, which can control the step motor of the filter wheel via step motor driver circuit.

  • Page 45: Detection Of The Input Signal

    4.5.9 Detection of the Input Signal Figure 4-10 Graph of input signal detection The system should detect the signal from filter position sensor, aspirate button, cuvette temp. controlling fan blocking. Before detected by control module, all input signals should go through the level translation circuit. 4.5.10 Analogue Board Control Figure 4-11 Graph of analogue board controlling Three signals are controlled by analogue board: digital potentiometer control signal...

  • Page 46: Lcd&Touchscreen Board

    The temperature sensor outputs the voltage signal to the analogue board, where it will go through amplification and modulation. Finally, it will be output at the inputting end of the AD converter through selectable switch. The AD converter receives control signal from the CPU extension board and samples the processed photoelectric/temperature signal and sends the AD value to CPU extension board for processing.

  • Page 47: Power Board

    D5: touchscreen valid-clicking indicator Power board 4.8.1 Overview The power board provides stable and reliable DC power to the modules and devices of the system. The circuit is of Flyback converter structure, providing ＋24V, ±12V and ＋ 5V voltage to the system and the functions of over-current protection, over-power protection and over-voltage protection are available on the system.

  • Page 48: Lcd Background Adjustment

    LCD Background Adjustment If the power board or CPU extension board is serviced or replaced, the LCD background voltage might change. To ensure the voltage meet the requirement, it is necessary to adjust it. The procedure for adjusting is shown as follows: Install all the boards back and ensure all the connections are well connected;...

  • Page 49: Connection Of The Hardware System

    4.10 Connection of the Hardware System Figure 4-15 System connection 4.10.1 Definition of the CPU Board + CPU Extension Board Interface Figure 4-16 CPU board + CPU extension board interface 4 Hardware 4-11...

  • Page 50: Analogue Board Interface

    4.10.2 Analogue Board Interface Figure 4-17 Analogue board interface 4.10.3 Power Board Interface Figure 4-18 Power board interface 4-12 4 Hardware...

  • Page 51: Lcd&Touchscreen Board Interface

    4.10.4 LCD&Touchscreen Board Interface Figure 4-19 LCD& touchscreen board interface 4 Hardware 4-13...

  • Page 53: Service And Maintenance

    Service and Maintenance To ensure reliability, good performance and service life of the system, regular maintenance is required. Be sure to follow the instructions given below to maintain the system. Even you’re only an operator, it’s very important for you to learn this chapter.

  • Page 54: Maintenance

    Maintenance 5.1.1 Daily Maintenance Use neutral wash solution and wet cloth to clean the spillage on the instrument. Wash the tubing with distilled water or DI water before shutting down the analyzer (for instrument installed with flow cell). When the system is not in use, make sure that the tubing and the flow cell is filled with clean distilled water (or DI water).

  • Page 55: Software Upgrading

    If the optical surface of the flow cell is contaminated, use cloth soaked with certain amount of absolute alcohol to clean it. 5.1.3.2 Adjust the photoelectric gain Photoelectric gain should be adjusted, if it is low. After entering the Maintenance screen, click Gain adjust to pop up the Gain adjust page.

  • Page 56: Software List

    Figure 5-1 System structure of the software 5.2.2 Software List The software on CPU board that should be upgraded: Name Code Example File or file folder Version BA89 operating G87048 G87048-xxxxxx analyzer software BA89 operating G87057 G87057-xxxxxx mdres（file folder） software resource package BA89 printing template...

  • Page 57: Upgrading Procedures For Software On Cpu Board

    The software on CPU extension board that should be upgraded: Name Code Example File or file folder Version BA89 control software G87049 G87049-xx semiauto_mcu.hex （ lower computer ） _ijsresource packagepgraded: driver, printing software, printing software resource package, pringer dir CPU extension board G87045 G87045-xx ba89cpuextendboard.pof...
  • Page 58 It will take about 15 minutes for the system to initialize, then the interface to detect the upgrading program on the U disk will be displayed. Click Yes to pop up the interface for upgrading. The upgrading time is in direct proportion to the size of the file. It will take 10 minutes to upgrade the operating software.

  • Page 59: Upgrading Procedures For Software On Cpu Extension Board

    5.2.4 Upgrading Procedures for Software on CPU Extension Board Please make sure the FPGA software or lower computer software has been copied to relevant directories on U disk. If not, execute the CPU board software upgrading again. But only FPGA software or lower computer software is needed to be copied the U disk.
  • Page 60 After confirming that the FPGA software or the lower computer software has been copied to the instrument memory, enter the Maintenance interface. Click Advanced to pop up the dialog box shown in the following figure. Enter the password—analyzer and click OK. And the following screen will be displayed: 5 Service and Maintenance...
  • Page 61 Click Lower upgr and the Lower computer upgrading dialog box will be displayed. Click start and a dialog box notifying the user to shut down lower computer communication will be displayed. 5 Service and Maintenance...
  • Page 62 After upgrading is completed, a dialog box will pop up to notify the user to restart. Restart the system. 3 Click Advanced to enter the following screen; 5-10 5 Service and Maintenance...
  • Page 63 Click FPGA upgr and the FPGA upgrading dialog box will be displayed. Click Start and a dialog box notifying the user to shut down lower computer communication will be displayed. After upgrading is completed, a dialog box will pop up to notify the user to restart. 5 Service and Maintenance 5-11...

  • Page 64: Replacing The Tubing

    Restart the system. 4 When the software upgrading is completed, enter Setup-Basic to check whether the software is of the latest version. Maintenance 5.3.1 Replacing the tubing The tubing is a component that should be replaced regularly. When the instrument is in use, if you notice that the instrument can not aspirate or aspiration volume decreases obviously, check for leakage in the peristaltic pump.
  • Page 65 Locate the position where the peristaltic pump is installed. Pull out the tubing that goes through the backboard of the analyzer for 40-50mm until the adapter is exposed. Pinch the two buckles on the left and right side of the pump shell and detach the pump head carefully. Pull tubing slightly...
  • Page 66 After unplugging the adapters, pinch the buckles on the pump head and detach the pump shell. Pinch buckles pump head detach pump shell. After detaching the pump shell, press the roller inside the pump to take the used pump tubing out. Remove the red ring on the used tubing and install them on the new tubing.
  • Page 67 After mounting the pump shell, install the pump head on the pump. Install pump head on the pump, with motor shaft into installation hole Pinch buckles to lock the pump head After installing the pump head, connect the tubing with the tubing that goes through the backboard and the waste tubing.

  • Page 68: Replacing Aspiration Tubing

    BIOHARZARD When replacing the pump tubing, wear gloves and lab coat and, if necessary, goggles. In case your skin contacts the waste, follow standard laboratory safety procedure and consult a doctor. NOTE The service life of the pump tubing is 18 month. Tubing should be checked irregularly and replaced in time.

  • Page 69: Replacing Lamp

    Connect the thicker end of the new tube to the inlet metal tube and then guide the tube through the deflection tube. thicker connected with the metal tube Aspiration deflection tube BIOHAZARD When replacing the pump tubing, wear gloves and lab coat and, if necessary, goggles.
  • Page 70 Open the optical window cover, use cross screw driver to unscrew the screws on the lamp replacement window cover. Remove the cover. Unscrew screws remove replacement window cover Unscrew the fastening screw of the lamp base (if it is difficult to dismount, some tools like the clipper might be used).

  • Page 71: Replacing Cpu Board

    Pull the wire out and you can see the wire joint connecting the lamp assembly, with one end connecting to the lamp and the other end connecting to the inside of the instrument. Pinch both ends of the joint and press the buckle to disconnect the joint.
  • Page 72 deviation can not be directly measured in operating software, so they are configured by other methods. The configuration procedures are shown as follows: Find the “sensor parameter A, B and C”, “filter wheel home position deviation” and “340 nm peak wavelength” in parameter configuration based on the SN. Click Maintenance on the main screen of the instrument.

  • Page 73: Troubleshooting

    Troubleshooting This chapter presents all warning messages and recommended corrective actions, which should be taken in time once any error occurs. When an error or failure occurs, relevant alarm message will be displayed, and the system will take corresponding actions.The logs will record the time, level, code and detailed information of each warning to help user record and search errors.

  • Page 74: Errors To Warn User (0)

    6.2.1 Errors to Warn User (0) The movement of the system and the test result will not be affected, however, the user should be informed of the error.After calibration is completed, calibration formula can not be gained, but the previous calibration formula can be used to calculate the formula and the test will not be affected.

  • Page 75: Details

    Details Corrective measures Code Level Description Causes provided by log Above Reference ↑ High Above Reference ↓ （ ） Test Nonlinear calibration Recalibrate Calibration monotone curve is not monotone checking error When calculating Iterative nonlinear calibration convergent while result, if no qualified calculating Rerun result is obtained after...
  • Page 76 reaction curve has no limit are less than 3 linear interval （ XX Test ） （ xx sample or calibrator Reaction data does not control ） The Rerun or rerun after dilution meet linearity criteria reaction curve Out of linear range （...
  • Page 77 Confirm ambient Ambient temperature temperature; check connection too low; Temp. data collection error; semi-conductor refrigeration Temperature too low refrigeration plate error; plate; restart the system; main board error; replace refrigeration refrigeration plate plate; replace invalid. temperature sensor; replace the analogue board Too much fluctuation of ambient temperature;...
  • Page 78 Check whether connection of the CPU board or CPU extension board is Handshake failed Communication error! loosen; CPU board or CPU extension board is damaged and should be replaced Check whether connection of the CPU board communication Filter wheel does not or CPU extension board is between respond in maximum...
  • Page 79 P/N: BA89-20-87067 (V1.1)

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