Mindray BA-88A, Operation Manual

Page 1: ...BA 88A Semi auto Chemistry Analyzer Operation Manual...

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Page 3: ...r whatsoever without the written permission of Mindray is strictly forbidden BeneView WATO BeneHeart are the registered trademarks or trademarks owned by Mindray in China and other countries All other...

Page 4: ...l not extend to any Mindray product which has been subjected to misuse negligence or accident any Mindray product from which Mindray s original serial number tag or product identification markings hav...

Page 5: ...ilding 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 Name Shanghai International Holding Cor...

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Page 7: ...structed by this manual Conventions Safety Symbols Safety symbols alert you to potentially dangerous conditions and information that requires your attention These safety symbols together with related...

Page 8: ...es that this product should not be treated as household waste By ensuring that this product is disposed of correctly you will help prevent bringing potential negative consequences to the environment a...

Page 9: ...3 Graphics All graphics including screens are for illustration purpose only and must not be used for any other purposes...

Page 10: ...quipment failure and even electric shock Do not place sample and reagent on the analyzer In case of spillage switch off the power immediately remove the spillage and contact our company customer servi...

Page 11: ...serve the following instructions to protect against the biohazardous infection BIOHAZARD Inappropriately handling samples may lead to biohazardous infection Do not touch the sample mixture or waste wi...

Page 12: ...sult the manufacturer or distributor of the reagents for details Wear gloves and lab coat and if necessary goggles Treating Waste Analyzer Please observe the following instructions to dispose of the w...

Page 13: ...system in an environment specified by this manual Installing and operating the system in other environment may lead to unreliable results and even equipment damage To relocate the system please conta...

Page 14: ...rate the system strictly as instructed by this manual Inappropriate use of the system may lead to unreliable test results or even equipment damage or personal injury Before using the system for the fi...

Page 15: ...cord before cleaning Take necessary measures to prevent water ingression into the system otherwise it may lead to equipment damage or personal injury Replacement of such major parts as lamp assembly...

Page 16: ...ed before being analyzed by the system Consult the reagent manufacturer or distributor for details Reagents Calibrators and Controls CAUTION Use appropriate reagents calibrators and controls on the sy...

Page 17: ...stem is responsible for ensuring that the system work normally and complies with the safety and EMC requirements If you have any problem consult the technical services department of your local represe...

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Page 19: ...Installation 2 1 2 2 1 System Specifications 2 1 2 2 2 Environmental Requirements 2 1 2 2 3 Space and Accessibility Requirements 2 2 2 2 4 Water Requirements 2 2 2 2 5 Waste Bottle 2 2 2 3 Installatio...

Page 20: ...enance 5 2 5 3 Irregular Maintenance 5 2 5 3 1 Cleaning Flow Cell 5 2 5 3 2 Adjusting the Photoelectric Gain 5 3 5 3 3 Calibrating the Peristaltic Pump 5 3 5 3 4 Replacing the tubing 5 3 5 3 5 Replaci...

Page 21: ...III Appendix C External Printer C 1 Appendix D Supplies D 1...

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Page 23: ...1 Introduction 1 1 1 Overview The system consists of the analyzer built in microprocessor popup keyboard internal printer and LCD screen 1 1 2 Outlook The front view of the semi auto chemistry analyz...

Page 24: ...1 2 Figure 1 1 Front View of the Semi Auto Chemistry Analyzer The rear view of the semi auto chemistry analyzer is shown in figure 1 2 Figure 1 2 Rear View of the Semi Auto Chemistry Analyzer...

Page 25: ...st storage capacity Up to 200 tests information 1000 control results Weight 7kg Dimension 420mm 350mm 158mm length width height Power supply 100V 240V 10 fluctuation 50 60Hz 3Hz fluctuation Input powe...

Page 26: ...ect and to switch between upper case and lower case Select and click a letter The letter is input in upper case but the following letters will be input in lower case Select All letters you then enter...

Page 27: ...w connecting to the power supply and USB port WARNING The printer must be connected to properly grounded power socket NOTE You are recommended to use printers that are compatible with the system and l...

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Page 29: ...check the delivered goods against the packing list as well as the appearance of the system If you find anything missing or damaged immediately alert Mindray customer service department or your local d...

Page 30: ...y grounded Improper grounding may lead to electric shock and or equipment damage Be sure to connect the system to a power socket that meets the above mentioned requirements and has a proper fuse insta...

Page 31: ...started The system will enter the main screen after self check and tubing washing If cuvette mode is selected tubing wash is not needed 7 After system is stabilized request 1 2 tests and run Evaluate...

Page 32: ...DI water for instrument with flow cell installed 2 5 Storage for Long Period When storing the analyzer for a long period please ensure that analyzer and accessory in the package be stored Temperature...

Page 33: ...g operations 1 Check the power supply and make sure it can supply proper voltage for the analyzer 2 Check if the power cord of the system is properly connected 3 Check and make sure sufficient printin...

Page 34: ...hermal recorder is applied skip this procedure 3 Place the power switch to On The system starts initialization which takes about 2 minutes During this process aspirate DI water as directed by the mess...

Page 35: ...You can determine whether it is necessary to enter linearity range reagent blank absorbance absorbance limit and linearity limit etc Refer to 4 2 1 2 Restriction for more information Click Parameter...

Page 36: ...box of S1 S8 Put the inlet tube into the calibrator to be tested and click Aspirate If it is multiple point calibration you can proceed to the next step only when the calibration tests of all the cal...

Page 37: ...with the reagent and click Aspirate Repeat this to test other samples 9 After calibration is finished Click QC and select controls from the drop down list box C1 C3 Put the inlet tube into the contain...

Page 38: ...to print the report On the main screen click Result Sample Select the sample to be edited and click Edit to enter the patient information including name gender age etc Click Print to print the patien...

Page 39: ...go through initialization procedure as shown in the following figure Figure 4 1 Initialization Screen After passing the self checking the system will prompt message to aspirate distilled water Press A...

Page 40: ...2 Main Screen 4 2 Parameter Click Parameter to enter the parameter screen as shown in figure 4 3 The tests include routine profile calculation and off system The left list indicates the name of the s...

Page 41: ...t is Endpoint Direction It refers to the changing direction of the absorbance during the reaction process including Inc and Dec If the absorbance increases select Inc otherwise select Dec Pri Primary...

Page 42: ...s usually more than 30sec The reading interval is 1 sec for single wavelength and 2sec for double wavelengths Unit Unit of the result Select from the drop down list The options include g L mmol L umol...

Page 43: ...ult and to note the operator Figure 4 4 Restriction information The following table explains the parameters on the Restriction Page Parameter Description Default reference Normal range of test result...

Page 44: ...lysis the absorbance limit is seen as the substrate depletion limit NOTE The absorbance limit is entered in the format of real value 10000 Lin Limit It is only valid for Kinetics The range is 0 1 The...

Page 45: ...set point The set point of the calibrator is arranged from lowest to highest The void means 0 concentration If set points are not set according to the above rules error message will appear S1 S8 NOTE...

Page 46: ...entrations and one QC rule for each test For any level of control once any one of the parameters control lot concentration or SD is entered you should enter the rest of the parameters to complete the...

Page 47: ...tons Function Add Add a new profile Enter the profile name in the Profile name text box select tests in the list below the box and then click save Delete Delete the selected profile The tests listed o...

Page 48: ...ill appear Unit Unit of the result Select from the drop down list The options include g L mmol L umol L U L mg dL IU L mg L and void The default is void The units can be added and deleted in Setup Pre...

Page 49: ...roduces the buttons on the screen Buttons Function Add Add a new calculation Delete Delete selected calculation Save Save the new calculation or the modified calculation Cancel After selecting a test...

Page 50: ...me should not exceed 10 characters Otherwise warning messages will appear Unit Unit of the result Select from the drop down list The options include g L mmol L umol L U L mg dL IU L mg L and void The...

Page 51: ...according to the testing order The following shows an example 001 ALT AST TP ALB 002 ALT AST GLU 003 TP ALB 004 ALT GLU The test list shows tests which have been requested but not yet run These tests...

Page 52: ...he patient Tests The names of the on board tests Profiles The names of the defined profiles The following table introduces the buttons on the screen Buttons Function Save Save the information of newly...

Page 53: ...heck the requesting information of all the samples Information can be arranged and printed by test or by sample Return Click this button to return to the main screen 4 3 2 Test Click Test on the main...

Page 54: ...ows Standby When sample or other solution to be tested is selected the area shows Please aspirate When system fails the area shows error When temperature is not stabilized the area shows Temperature s...

Page 55: ...e completion of a sample test the sample ID of the sample blank will increase by 1 if requesting is applied increase the sample ID according to requesting Calibrate Run selected tests of the calibrato...

Page 56: ...lowing introduces the buttons on the screen Buttons Function QC record Click this button to view the QC result of the selected test Please refer to 4 5 for more details Cal record Click this button to...

Page 57: ...liable We recommend you to wash the cuvette using ethanol solution the volume ratio of ethanol and water is 4 1 or wash solutions specific for cuvette For more details please refer to 5 3 1 1 Low Back...

Page 58: ...13 Calibration The following table explains the parameters on the Calibration Details Parameter Description Test Test that has been calibrated Date The date when calibration of the test is run Rule Ca...

Page 59: ...e calibration formula The following introduces the buttons on the screen Buttons Function Edit Edit the parameters in the linear calibration equation Enter new values in the K and R0 text box click OK...

Page 60: ...and check whether the test is out of control and print QC reaction curve in the QC screen Figure 4 14 QC The following table explains the parameters on the screen Parameter Description Test All the t...

Page 61: ...e QC curve and the result of the selected test and control within the specified time range The following introduces the buttons on the screen Buttons Function Delete Delete all the QC result of select...

Page 62: ...ll the test result of the current day in the list on the right side of the screen Patient Name of patient Sample ID Sample ID of the patient Unit Unit of the test result Test Date The date when test i...

Page 63: ...esult to enter the Edit page or enter the page directly The editing function will be elaborated separately in the following Delete Delete all the result of the selected test when it is displayed by te...

Page 64: ...er to the above for parameter on Test screen The following table introduces the buttons on the Test screen Buttons Function Query Click Query to pop up the following page Select data range or patient...

Page 65: ...to the main screen 4 6 2 Edit Click Edit or Add in Result window to enter the screen to edit the result report When you enter the screen by clicking Edit the sample ID can not be edited when you ente...

Page 66: ...of the test Conc Test result Unit Unit of the test result Reference Reference range of the test Response Response of the test Original Original result of the test If the result is edited the original...

Page 67: ...Off system tests and flags can be added or deleted in Setup Dictionary Edit After selecting a test result click Edit to pop up the following screen Enter new result in Quantitative area or select fla...

Page 68: ...ester Name of the doctor who tested the sample You can add or delete the names in Setup Dictionary Test Date The date when sample is tested Send Date The date when sample is sent to be tested Reviewed...

Page 69: ...on Pump speed 3 pump speeds are available 1 2 3 The default which is recommended to the user is 1 When there are some impurities in the flow cell or tubing that can not be cleared select pump speed 2...

Page 70: ...might be affected It is necessary to calibrate the touchscreen Follow the instructions on the screen to complete the touchscreen calibration as shown in the following figure Save Save the information...

Page 71: ...name of the doctor who reviews the sample result Qualitative result Add delete qualitative result type The following table introduces the buttons on the Dictionary screen Buttons Function Add Add new...

Page 72: ...time The following table introduces the button on the screen Buttons Function Top Move the selected test to the top of the list Up Move the selected test upward by one line Down Move the selected test...

Page 73: ...IS setup Figure 4 23 LIS setup Enter specified information in LIS manufacture and LIS Set the Index of Test config Result Setup Unit and Type according to the index No provided by LIS The operation is...

Page 74: ...rument reg Channel No setup the channel No of fields like test information sample type should be consistent with System LIS setup in BA 88A otherwise the information can not be uploaded correctly Afte...

Page 75: ...is screen Figure 4 25 Log Error list is on the left side of the Log screen On the right side of the screen detailed information about the selected item is shown including Error Info Causes and Correct...

Page 76: ...unction is only available to service personnel and authorized distributors Figure 4 26 Maintenance 4 8 3 1 Pump Calibration Figure 4 27 Pump calibration Pump Cal can facilitate the calibration of peri...

Page 77: ...After replacing the lamp cuvette filter or when alarm messages like Light signal too weak Light signal too strong appears the Gain adjust can be used to adjust the light intensity to proper degree Th...

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Page 79: ...rranty or service contract and even cause personal injury Do not spill water or reagent on mechanical or electrical components of the system BIOHARZARD Wear gloves and lab coat and if necessary goggle...

Page 80: ...r 10 seconds 3 Wash with ethanol solution for 5 seconds again and then wait for 10 seconds Wash the tubing with DI water for 10 20 seconds The cleaning is completed 4 Other recommended wash solutions...

Page 81: ...fected because of unstable light source NOTE The lamp must be replaced when its light intensity attenuates to the specified threshold When the range of background preset by the system can not be resto...

Page 82: ...apter is exposed Pinch the two buckles on the left and right side of the pump shell and detach the pump head carefully 3 After detaching the pump head unplug the tubing yellow whose adapters are close...

Page 83: ...out Remove the red ring on the used tubing and install them on the new tubing Install the new pump tubing on the pump and carefully pull it to make the tubing fit well with the inside of the pump with...

Page 84: ...se to the outside 9 Check the installation for any errors Connect the analyzer to the power supply and calibrate the pump Please refer to the relevant part of the operator s manual for calibration met...

Page 85: ...ck and forth slightly Calibrate the pump after replacing the pump tubing Otherwise the aspiration volume might not be correct and the test may be affected 5 3 5 Replacing Aspiration Tubing During oper...

Page 86: ...ld be on the same level with the installation surface Otherwise the test result might not be reliable NOTE When connecting the tube the tube should reach the root of the metal tube to ensure reliabili...

Page 87: ...ening screw of the lamp base if it is difficult to dismount some tools like the clipper might be used Put the screws in a proper place outside the instrument Pinch the lamp base directing line and the...

Page 88: ...ck the background after the instrument is stabilized to check whether the replacement is successful WARNING If you want to replace the lamp first switch off the power and then wait at least 15 minutes...

Page 89: ...sed for tests determined by colorimetry Nonlinear calibration includes Logit Log 4P Logit Log 5P Exponential 5P Polynomial 5P Parabola and Spline They are mainly used for tests determined by turbidity...

Page 90: ...rameters a and b This calibration method requires n n 3 calibrators i C is the concentration of calibrator i i R is the response of calibrator i a and b can be obtained through the method of least squ...

Page 91: ...this method has a higher fitting Exponential 5P Calibration formula ln ln ln exp 3 2 0 C c C b C a K R R This calibration method adopts five parameters 0 R K a b and c This calibration method require...

Page 92: ...tors The calibration parameters can be calculated through the method of polynomial least squares Spline Calibration formula 3 2 0 i i i i i i i C C c C C b C C a R R This calibration method requires 2...

Page 93: ...re 0 R K a b calibration parameters Logistic Log 5P The positive real root is obtained with the dichotomy method Exponential5P The positive real root is obtained with the dichotomy method Polynomial5P...

Page 94: ...e control value exceeds 2 standard deviations Warning 13S One control value exceeds 3 standard deviations Out of control random error systematic error 22S Two consecutive control values for one level...

Page 95: ...Figure 6 3 Westgard Multi rule QC Conclusion Flow For several controls the conclusion logic is similar to the above condition except for multiple continuous QC data which should be combined simultaneo...

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Page 97: ...rce tungsten halogen lamp 6V 10W Wavelength 340nm 405nm 510nm 546nm 578nm 630nm Optional 450nm 670nm A 2 Power Requirements Power supply 100 240V 50 60Hz Input power 140VA A 3 Environment Requirements...

Page 98: ...equipment powered by external equipment Overvoltage type II Pollution level 2 Device type fixed device Work type Continuous Protection degree against poisonous liquid common device Sterilization meth...

Page 99: ...ervice department or your local distributor Reagent blank out of range RBK Reagent goes wrong Cuvette is dirty Rerun after replacing the reagent or reset the limit parameters No Linear Interval NLN Me...

Page 100: ...lection error refrigeration plate error main board error refrigeration plate invalid Restart the system If the alarm continues contact Mindray customer service department or your local distributor Fan...

Page 101: ...uit error If it happens in two consecutive times contact the developer Light signal too strong 012 Photoelectric gain adjusting error Restart the system If the alarm continues contact Mindray customer...

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Page 103: ...C External Printer The system is compatible with not limited to the following printers HP DeskJet 5652 HP DeskJet 3820 HP DeskJet 5438 HP DeskJet 3668 HP DeskJet D2368 HP Photosmart D5168 HP Business...

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Page 105: ...n Lamp assembly BA89 30 86998 Lamp base Regularly replace d part Flow cell M90 000168 Cuvette installation hole inside the optical window Replace it when damaged Internal printer assembly BA89 30 8703...

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Page 107: ...P N BA89 20 87038 1 0...