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AmericanNationalStandardANSI/AAMISP10:1992AAMIAssociationfortheAdvancementofMedicalInstrumentationElectronicorautomatedsphygmomanometersAssociationfortheAdvancementofMedicalInstrumentation1110N.GlebeRd.,Suite220Arlington,VA22201-4795©2000bytheAssociationfortheAdvancementofMedicalInstrumentationAllRightsReservedCopyrightandPermissionsPublication,reproduction,photocopying,storage,ortransmission,electronicallyorotherwise,ofalloranypartofthesedocumentswithoutthepriorwrittenpermissionoftheAssociationfortheAdvancementofMedicalInstrumentationorthecopyrightholder(ifnotAAMI)isprohibitedbylaw.Itisillegalunderfederallaw(17U.S.C.§101,etseq.)tomakecopiesofalloranypartofthesedocuments(whetherinternallyorexternally)withoutthepriorwrittenpermissionofthecopyrightholder.Violatorsrisklegalaction,includingcivilandcriminalpenalties,anddamagesof$100,000peroffense.Forpermissionregardingtheuseofalloranypartofthesedocuments,contactAAMI,1110N.GlebeRoad,Suite220,Arlington,VA22201-4795.Phone:[phone];Fax:[phone].ViolatorsofthiscopyrightpolicyshouldbereportedtoAAMI’slegalcounsel:McKenna&Cuneo,L.L.P.1900KStreet,N.W.Washington,DC20006Attn:JacquelineA.Henson,Esq.Phone:[phone]SP10ElectronicorAutomatedSphygmomanometersAmericanNationalStandardANSI/AAMISP10-1992ElectronicorautomatedsphygmomanometersDevelopedbyAssociationfortheAdvancementofMedicalInstrumentationApproved16October1992byAmericanNationalStandardsInstitute,Inc.ABSTRACT:Thisstandardestablisheslabelingrequirements,safetyandperformancerequirements,andrefereetestmethodsforelectronicorautomatedsphygmomanometersusedintheindirectmeasurementofbloodpressure.Specificrequirementsforambulatorybloodpressuremonitorsareincluded.AssociationfortheAdvancementofMedicalInstrumentationSphygmomanometerCommitteeThisstandardwassubmittedtoAAMIbytheAAMISphygmomanometerCommittee.Committeeapprovalofthestandarddoesnotnecessarilyimplythatallcommitteemembersandreviewersvotedforitsapproval.Thecommitteecurrentlyhasthefollowingmembers:Cochairpersons:AlanS.BersonCarrollRobbinsMembers:AlanS.Berson,PhD,NationalHeart,Lung,andBloodInstitute,NIHCesarA.Caceres,MD,ClinicalSystemsAssociatesJaniceB.Flynn,Atlanta,GeorgiaSandraS.Garrett,MediFactsRodolfoI.Godinez,Children'sHospitalofPhiladelphiaMichaelHayes,W.A.BaumCo.MichaelJ.Jamieson,MD,UniversityofTexasHealthSciencesCenterRichardLiberace,FDAWinchesterEngineeringandAnalysisCenterJackMillay,SpaceLabsMedical,Inc.AnthonyV.Picardi,DefensePersonnelSupportCenterL.MichaelPrisant,MD,MedicalCollegeofGeorgiaCarrollRobbins,TycosInstrumentsSheldonG.Sheps,MD,MayoClinicIrvineA.Speelman,PropperManufacturingCompanyBrianSteffens,MarquetteElectronicsInc.LeonardSteinfeld,MD,MountSinaiMedicalCenterLeeTaylor,MD,ProtocolSystemsGregoryWelyczko,OhmedaAnesthesia©2000AssociationfortheAdvancementofMedicalInstrumentationWilliamWhite,MD,UniversityofConnecticutHealthCenterMichaelWillingham,EliLilly&CompanyAlternates:GlennPelikan,SpaceLabsMedical,Inc.ToddRoberts,MarquetteElectronicsInc.EdwardJ.Roccella,MD,NationalInstitutesofHealth,NIHNOTE—Participationbyfederalagencyrepresentativesinthedevelopmentofthisstandarddoesnotconstituteendorsementbythefederalgovernmentoranyofitsagencies.AcknowledgmentsThecommitteegratefullyacknowledgesthecontributionsofGailBrillo,NationalHeart,Lung,andBloodInstitute-NationalHighBloodPressureEducationProgramcontractstaff;LeoCostello,ClinicalDynamics;DavidFlaugherandEdPeart,TycosInstruments.ForewordThisstandardwasdevelopedbytheAAMISphygmomanometerCommittee.Theobjectiveofthisstandardistoprovidelabeling,safety,andperformancerequirementsthatwillhelpensurethatconsumersandhealthcareprofessionalsaresuppliedwithsafe,accuratedevicesfortheindirectmeasurementofbloodpressure.ItishopedthattheprovisionsofthisstandardwillcontributepositivelytotheaccuracyofnoninvasivebloodpressuremeasurementsofallsubjectsandspecificallytothedetectionandcontrolofhypertensionintheUnitedStatespopulation,bysettingforthrequirementsforthelabelingandperformanceofelectronic/automatedsphygmomanometersusedinthediagnosisofthedisease.Bloodpressuremeasuredwithinanarterygenerallydiffersfromthatmeasuredindirectlybytechniqueswhichdonotrequireintraarterialcatheters.Thenoninvasivecuff/stethoscopetechnique,basedonKorotkoffsoundsidentifiedbyanindividualtrainedinauscultation,hasbeenfound,however,toproduceresultsdirectlyrelatedtointraarteriallymeasuredbloodpressuresandtobevaluablefordeterminingwhetheranindividualhaselevatedbloodpressure.Thetechniqueisalsousedwithindividualswhoareonmedicationtoassesshowwelltheirbloodpressureisbeingcontrolled.Otherindirectbloodpressuremeasurementtechniquesshouldbeatleastasaccurateasthecuff/stethoscope,nonautomatedtechnique.Alternatively,theefficacyofanindirectbloodpressuremeasurementdevicecanbedeterminedbycomparingitsmeasurementswithdirectintraarterialmeasurements.Thisstandardpermitseithervalidationmethod.Theconceptsincorporatedinthisdocumentshouldnotbeconsideredinflexibleorstatic.Thisstandard,likeanyother,mustbemodifiedasadvancesaremadeintechnologyandasnewdatabecomeavailable.AAMIstandar