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6-1

6

Calculating Calibration

Parameters and QC Rule

The system provides two calibration methods: linear calibration and nonlinear
calibration. Linear calibration includes one-point linear calibration, two-point linear
calibration and multi-point linear calibration. They are mainly used 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.

In this section,

R

- calibrator response

C

- calibrator concentration (activity)

K

,

R

0

,

a

,

b

,

c

- calibration parameters

6.1 Calculating Linear Calibration Parameters

One-point linear calibration

Calibration formula:

aC

R

=

This calibration method adopts only one calibration parameter

a

,

=

a

C

R

.

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Содержание BA-88A

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

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 6: ......

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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Страница 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...

Страница 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...

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

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 28: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 78: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 102: ......

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

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