监护仪、除颤仪临床应用质量保障

上海交通大学硕士学位论文监护仪、除颤仪临床应用质量保障姓名：张红蕾申请学位级别：硕士专业：生物医学工程指导教师：王一抗;李斌20090506IIITHEQUALITYASSURANCEOFCLINICALAPPLICATIONOFMONITORANDDEFIBRILLATORABSTRACTWiththedevelopmentofmodernbiomedicalengineeringtechnologyindustry,medicaldeviceshavebecomeanimportanttoolformedicalstaff,thequalityofmedicalequipmentsisoneofthemostimportantfactorswhichaffectthemedicalserviceslevel.Therefore,establishingandconsummatingthehospitalmedicalequipmentsqualitycontrolmechanismswiththediscussingofcorrespondingtheoriesandmethodshaveagreatsignificance.Monitoranddefibrillator,whichusedforthefirstaidandintensivepatientscare,playimportantrolesandhavespecialpositionsinmedicalequipments.However,comparedwithotherlargeequipmentsinthehosptials,thesetwoequipmentsarecharacterizedbylowpriceandlargernumber,whichmakethembepaidlessattentionofcareandmaintenanceintheusingprocess.Soitisdifficulttoguaranteethelevelofquality.Atthesametime,monitoranddefibrillatorwillalsohavevariouserrorsinusingbecauseoftheimpactofdifferentfactors.Howtominimizetheamountoferrorswillbecomearesearchofqualitycontrol.Thisthesis,basedonthequalitytestingandexperimentsoftheexistingShanghaiSixthPeople'sHospital'smonitoranddefibrillator,graspsthequalityofexistingequipments.italsobasedontheexperimentaldataandtesting,combinedwiththeclinicalworkproblems,toanalyseandimproveconclusionsandrecommendationsrelatedIIItoqualitymanagementstandards,whichwillcontributetotheplannedscientificmanagement,therationaluseofmedicalequipmentresources,thereductionofmedicalequipmentduplicationandthefullutilizationofmedicalequipmentinthehospitals.Keywords:qualitycontrol,maintenanceandmonitoring,monitor,defibrillatorIII[t1]:200956IV[t2]200951220095126[l3]72.12.1.12.1.2200041“”82.1.3,,(Qualityassurance;QA)(Qualitycontrol;QC),2.22.2.1XCTPACS,,,,912%8020061041690(GHTF)20022002102.2.219894119939119954320004120066342.2.35060701976FDA1990(SMD90)2070FDA(Foodanddrugadministration),,FDA1984,19911992,56220,383811,,,,,,(clinicalengineeringdepartment)90(GHTF)98000200417110120150122.3,,,,,,,,;,,,,,,133.1,3-1Graph3-1Multi-ParameterMonitor143-2Graph3-2MonitorblockdiagramECCEEG12ECG34153.23-3Graph3-3DefibrillatorICUCCU3.2.1163-4Graph3-4Defibrillatorblockdiagram3.3.2VT/VF3-5Graph3-5WorkingprincipleofdefibrillatorCKC17LRLCR3.3.3RRRRRRR3.3.41962AED80AED90ICDICD1999FDA2000184.14.254.2.14.2.2ICUCCU9040%4.2.3194.2.44.2.54.34.4,,,,,(),,,50204.5215.1(1)(2)(3)20025.2(1)3155%5%2218792%70%5.3200412273070731235-15-1Graph5-1Goalofqualitycontrolandmethodsofpromote20053200820095.4FlukeBiomedicalFLUKE197820198552002LionhartBio-TekDNINevada,2430ISO9001Fluke2004FlukeBiomedicalFluke256.16.1.1SpO26.1.26.1.36.1.468266.26.2.16.2.26.2.36.36.3.112726.3.2119901998199865300100%20015200520062008(ACCE)287152105351831051841FLUKEBPPump2NIBPMs2FLUKEPS4203FLUKEIndex246.3.3(1),,“”.[l4]ISO9000:2000CEFDATÜVGMP--------------------“”-----29--------------------“”-----GB9706.1-1995YY0089-1992YY91079-19996.4SPSSSPSSStatisticalPackagefortheSocialSciences“”SPSSSPSS2000StatisticalProductandServiceSolutions“”SPSSSPSS11.03200M2060SPSS1975SPSS1984SPSSSPSS/PC+SPSSSPSSSPSS302530SPSS19941998SPSSSYSTATBMDPQuantimeISLSPSSSPSS“”“”SASSPSS11SPSSSPSSBaseAdvancedModelsRegressionModelsTablesTrendsCategoriesConjointExactTestsMissingValueAnalysisMapsBaseSPSS11SPSSSmartViewerSPSSReportWriterSPSSSPSSWindowsWindowsSASBMDPGLIMGENSTATEPILOGMiniTabSPSSEXCELSPSS“”SPSS6.4.1SPSSWindows31WindowsSASBMDPGLIMGENSTATEPILOGMiniTabSPSSEXCELSPOHTMLSPSS“”SPSS6.4.2SPSSanalysisofvarianceANOVA,knnkKkkT1T2…Tj…TkX11X21…Xi1…Xn1X12X22…Xi2…Xn2………………X1jX2j…Xij…Xnj………………X1kX2k…Xik…Xnk32Xijjiµµjjτjjτj=µj–µεijiddHoτ2j33=+jkSSt(sumofsquare,total)SSw(withingroup)nnSSb(betweengroup)SSt=SSb+SSwFMSbMSwMSeS21S22…S2mσ2MSbσ2F1134FkknnkkSStSSbF35αFFF36GB9706.1.119951YY0089-1992YY9107919997.1,FLUKE7.1.1BPPump2BPPump2NIBPMsBP-Pump27.1.2PS420PS4207.1.3Index2Index2Index2Index2Index2Index2%377.2,7.37.3.17.3.21mmHg120/809360/3040200/150166110/8090150/1101232BPPump2447-1Figure7-1BloodpressuretestingequipmentconnectiondiagramBPPump238343.2.2.17.3.31/min60802008-27-2Figure7-2Heartratetestingequipmentconnectiondiagram27-27.3.4128-238-2PS420397.3.51%909610028-38-3Figure8-3Oxygensaturationtestequipmentconnectiondiagram38-33.3.5.17.4:YY91079-1999YY0089-1992OPV-1500KYZB/JAP0565-200311.3kPa(10mmHg)(2.)2/34SpO22%Index2408.1Bio-TekQED-68.2,8.3QED-68.41l.53J215s3R30ms430-2205411621621621629.19.1169.1List9.1ECGpulsetestingdataofmonitor60802001infinityvista551373646059791992GammaXL5513494965559791993GammaXL5513494965559791994Vista539520227159792005Kappa549335516160802006Kappa549337045660802007Kappa549337235660802008Kappa549334085460802009Kappa5493373355607920010Kappa5493368949608020011Kappa5493341452608020014Kappa5493321260608020015Kappa5493303262608020016GammaXL5513139668597919917Delta5395102272608020019Delta539518965960802004260DescriptiveStatisticsNMinimumMaximumMeanStd.DeviationVAR0000216596059.69.479ValidN(listwise)16NValidN596059.690.47980DescriptiveStatisticsNMinimumMaximumMeanStd.DeviationVAR0000216798079.62.500ValidN(listwise)16NValidN7