MedicalDeviceScienceIntroduction医疗设备科学导论.ppt

LecturesonMedicalBiophysicsDepartmentofBiophysics MedicalFaculty MasarykUniversityinBrno 2 MedicalDevices Introduction LecturesonMedicalBiophysicsDepartmentofBiophysics MedicalFaculty MasarykUniversityinBrno 3 MedicalBiophysics InMedicalbiophysicswewillbedealingwiththephysicalprinciplesofbiomedicalmethodsanddevicesandtheirinteractionswiththehumanbody whichmakesthemusefulinhealthcare includingpatientandusersafetyaspectsandhealthcarequalityissues Thephysicalprocessesinlivingorganismsandtheeffectsofphysicalfactorsonthemareimportantasbackgroundinformation 4 Links Naturalsciences physics chemistryandbiochemistry biology MorphologicaldisciplinesPhysiologyandpathologicalphysiologyClinicaldisciplines almostall 5 Recommendedtextbook Thistextbookandallthepresentationsshowninthelecturesprovidetheinformationnecessarytobesuccessfulintheexam 6 Howtostudy Studyingmedicalbiophysics thereisnoproblemwiththeamountofknowledgewhichisnecessarytomaster butwithunderstandingthephysicalprinciplesandtheirapplication Memorisationwithoutunderstandingwillnotbesufficienttohaveasuccessattheexam 7 MedicalDevices Introduction 8 WhatisaMedicalDevice anyinstrument apparatus appliance materialorotherarticle whetherusedaloneorincombination includingthesoftwarenecessaryforitsproperapplicationintendedbythemanufacturertobeusedonhumanbeingsforthepurposeof diagnosis prevention monitoring treatmentoralleviationofdisease diagnosis monitoring treatment oralleviationoforcompensationforaninjuryorhandicap investigation replacementormodificationoftheanatomyorofaphysiologicalprocess controlofconceptionandwhichdoesnotachieveitsprincipalintendedactioninoronthehumanbodybypharmacological immunologicalormetabolicmeans butwhichmaybeassistedinitsfunctionbysuchmeans MDDArticle1 2a 9 TheEUMedicalDeviceDirectives TheMedicalDevicesDirective MDD 93 42 EEC OJL169p0001 0043 frombandages tonguedepressors thermometerstocontactlenses stethoscopes splints first aidkits breathalysers heartvalvesandimagingequipmentTheIn VitroDiagnosticMedicalDevicesDirective IVDD 98 79 ECOJL331p0001 0037 reagents controlstandards test kits equipment intendedforthein vitroexaminationofhumanspecimense g bloodgroupingreagents pregnancytestkits HepatitisBtestkitsTheActiveImplantableMedicalDevicesDirective AIMDD 90 385 EECOJL189p0017 0036 active i e includeanenergysource implantsorpartialimplantse g heartpacemakersMostcountrieshavetransposedthesedirectivesintoasinglenationallegislation e g UKMedicalDevicesRegulations2002 10 HealthCareActivities PreventionDiagnosisCurative therapeutic RehabilitationPalliativecare whencureisnotpossible 11 MedicalImagingDevices invivodiagnosis X rayprojectionimagingComputerisedTomography CT Ultrasound USI DopplerimagingMagneticresonanceimaging MRI Radionuclideimaging nuclearmedicine ThermographyEtc 12 Theoreticalbackground Ionisingradiation origin measurement interactionswithmatter propertiesofatomsandnucleus radioactivity basictermsofacoustics electromagneticspectrum MedicalImagingDevices invivodiagnosis 13 MedicalLaboratoryDevices invitrodiagnosis sampleseparation centrifugationetcelectrophoresis capillaryelectrophoresispH ISEmetersparticle cellcountersspectrophotometersflowcytometrymicroscopyHPLC chromatography clinicalchemistryhaematologyimmunologyscintillationsystemsgeneticanalysis 14 Theoreticalbackground Structureofbiopolymers propertiesofwaterandelectrolytes electricpropertiesoflivingmatter galvaniccell sedimentationofparticles dosimetry lightabsorption MedicalLaboratoryDevices invitrodiagnosis 15 PhysiologicalMeasurementDevices invivodiagnosis InstrumentsformeasuringphysicalandchemicalvariablesinvivoThermometersCardiovascularphysiology bloodpressuremonitors flowmeters pulsedDopplerUSsystemsElectrophysiology ECG EEG EMGAudiologyandophthalmologyRespiratoryphysiology spirometers pulseoximetry impedancepneumograph Endoscopes 16 PhysiologicalMeasurementDevices invivodiagnosis Theoreticalbackground Introductiontothermodynamics basiclawsofhydrodynamics originofbioelectricpotentials propertiesofsoundandlight earandhearing eyeandvision mechanicalpropertiesoflivingmatter 17 ECG akaEKG sphygmomanometer Screenofamultipurposeclinicalmonitor 18 PaediatricIntensiveCare 19 Endoscopy 20 RadiotherapyDevices X rayandelectron resp hadronbeamsfromaccelerators shape direction andintensityofbeamchangedoftencontinuously gamma raybeamsfromtele isotoperadioactivesourceslikeCo 60treatmentplanningsystemssimulatorsbrachytherapydosimeters Linearaccelerator Leksellgammaknife 21 RadiotherapyDevices Theoreticalbackground Ionisingradiation origin measurement interactionswithmatter propertiesofatomnucleus radioactivity biologicaleffectsofionisingradiation dosimetry 22 PhysicaltherapyDevices ElectrotherapyUVandIRtherapyShortwavediathermyUltrasoundtherapyLasertherapy Musclestimulator Lasertherapyunit Ultrasoundtherapyunit Shortwavediathermy 23 PhysiotherapyDevices TheoreticalbackgroundBiologicalinteractionsofultrasound electromagneticfields electriccurrent infrared visibleandultravioletlight laserprinciple 24 POC PointofCare Devices Addressclinicians requirementsforrapidaccesstoinformationtosupportcriticalcaredecisionsAdvancesinmicroelectronicsandbiosensortoolshavebroughttechnologytothebedsideinaminiaturizedform Examples Performingbloodtestsatthepatient ssideratherthaninacentrallaboratoryportableultrasoundimagingdevices 25 SurgicalTheatreDevices Lithotripsy Operatinglamps anaesthesia electrocautery cryosurgery 26 SurgicalTheatreDevices Lithotripsy TheoreticalbackgroundBiologicalinteractionsofultrasound electromagneticfields electriccurrent infrared visibleandultravioletlight laserprinciple lowtemperatures acousticshockwaves 27 SurgicalTheatreDevices 28 SurgicalTheatreDevices 29 ProstheticDevices Implants Roboticdeviceforkneeprosthesisimplantation 30 ProstheticDevices ArtificialOrgans Artificialheart Cochlearimplant Retinalimplant Ventilator Cardiopul monarybypass 31 ProstheticDevices ArtificialOrgans Stentsareinsertedintothedamagedbloodvessels oesophagusetc Theyareoftenmadeofametalwitha shapememory nitinol whichadoptstheintendedshapewhenheatedtobodytemperature 32 DisposableMedicalDevices Suctioncatheter Umbilicalcordclamp I V cannulae 33 DevicesforSelf testing homedevices deviceforself testing anydeviceintendedbythemanufacturertobeabletobeusedbylaypersonsinahomeenvironmentthermometers pressuremeasuringinstrumentsetctestkits pregnancy glucoselevelsinbloodusedbydiabetespatientsetc Bloodglucosemeter 34 DevicesforPerformanceEvaluationofDevices deviceforperformanceevaluation devicestochecktheperformanceofmedicaldevicesarealsoconsideredasmedicaldevices TestingcontrastresolutioninXRI 35 WhatisthePurposeofthisCourse Createawarenessthatmedicaldevicesshouldbeusedeffectivelyandsafely reducepatient occupationalandothers risktoaminimum UsemedicaldevicesinaprofessionalandscientificmannerAppreciateusesofmedicaldevicesintheclinicalareasandinresearchHaveanideaofthedevicesusedinotherprofessions 36 SomeCompetencesforUsersofMedicalDevicesWhatisexpectedthedoctordoeswithorknowsaboutthedevice Statethespecificdiagnostic therapeuticetcoutcomesexpectedwhenusingthedeviceExplainthephysicsprinciplesunderpinningthefunctioningofthedeviceandthedeviceuseprotocolsDescribethestructureofcommerciallyavailabledevicesincludinguseroptionsettingsandcontrolsIdentifypossiblehealthhazards e g mechanical electrical radiationetc topatient selfandcolleaguesDescribemeasurableobjectivedeviceperformanceindicatorswhicharedirectlyrelatedtodeviceeffectivenessorsafety 37 Cont Demonstratesalev