IEC 62366-可用性报告范例-Humidifier(1)

UsabilityFileMLD9.05eBSEN62366:2008DocumentationofComplianceProductDescriptionBubbleHumidifierProductSeriesACME001Issue:1Date:18.3.10Signed:JBloggs1InputstotheUSABILITYSPECIFICATION1.1SpecificationoftheINTENDEDUSE/INTENDEDPURPOSE1.1.1DescriptionTheACMEBubbleHumidifierhasbeendesignspecificallytobeusedwithOxygen.TheunitcanbeusedinmosttypesofmedicalenvironmentssuchasHospital,MedicalCentres,AmbulancesandDomesticpurposes.Thehumidifierworksbyconductinggasdownthesmallinternaltubethatissubmergedinwater.Thegaspassesthroughthediffuser(sinteredmetal),whichbreaksthegasintosmallbubbles,increasingthesurfacearea.Thebubblesfloatpassivelytothesurface,absorbingwatervapour.Thehumidifiedgasthenflowsoutthroughtheoutlet.ThebottlecomponentismouldedinautoclavableHDPE.TheHumidifierhasbeendesignedtoconnecttoFlowmeteringDevicesviaa9/16Connectorandthatcanprovideaflowratesfrom2to6Lpmwithabackpressureof4bar.1.1.2EQUIPMENTapplicationspecification1.1.2.1MedicalpurposeTohumidifythemedicalgasflow(Oxygen)toapatiente.g.viaattachedtubingandfacemask.1.1.2.2PATIENTpopulationa)Age:newborntogeriatricb)Weight:>2.5kgc)Health:notrelevantd)Nationality:multiplee)PATIENTstate:-PATIENTisnottheOPERATOR1.1.2.3PartofbodyortypeoftissueappliedtoorinteractedwithNodirectcontactwiththepatient–thoughattachedtubingandfacemaskwouldcontactnoseandmouth.1.1.2.4IntendedOPERATORTrainedmedicalorparamedicalstaffwhounderstandhowtoconnecttoaflowmeterandtheuseofhumidifiedoxygen.1.1.2.5Applicationa)EnvironmentGeneral:-Hospital-CareHome/Hospice-Ambulance-Couldbedamagedbyimpacte.g.droppingorcollision,thennotfunction.-Whenfunctioningisshallkeephumidifyingtheoxygen..Conditionsofvisibility:-Ambientluminance100–500lux-Viewingdistance20cmto1metre-Viewingangle:normaltothescale±20°Physical:-Workingpressure400kPa-Operationrange2to6Lpmrecommended-Permittedleakage-zero-Normalambientconditionsapply.b)Frequencyofuse:-Onceayearupto10timesadayc)Mobility:-Intendedtobefixedtogassupply,whichcouldbeonamobiletrolley.1.2PRIMARYOPERATINGFUNCTION1.2.1Frequentlyusedfunctionsa)Fillingwithwaterb)Readingscalec)Attachingto/removingfromgassupply/flowmeterd)Attachingtopatienttubing/facemask.e)Cleaning–canbesterilisedf)Storing1.2.2FunctionsrelatedtoSAFETYa)Readingscale–especiallywhenwatersupplyexhaustedb)Supplyingcorrectflowforcondition/patientc)Cleaningd)Servicing&maintenance1.3Riskanalysis1.3.1INTENDEDUSE/INTENDEDPURPOSESee1.11.3.2USERPROFILESee1.1.2.41.3.3ThingsThatcouldgowrongSources:Literature,DeviceAlerts,Sales,HealthcareStaff,RiskAnalysisetca)Duringnormaluse:-Waterhasrunout→levelnotvisibleb)UseErrors:-Notrefilling-Applyingexcessiveforce/mechanicalstress/tampering-Dropping/Impact-Blockage-Leakagec)Environment:-Explosionwhenexposedtoignitionsourced)Patient:-Tamperinge)Reading:-Notreadingwaterlevelcorrectlyf)Hygiene:-Cross-contamination1.3.4Taskrequirementsa)Clearlyrecognisableinstructionsonbottleb)Easilyassembled/disassembledc)Readable/legiblescaled)Easycleaningofdevicee)Light-weightdesignf)Easytoservice&maintain1.3.5ThecontextofuseSee1.1.2.51.3.6InformationonHAZARDSknownforexistingdeviceIncludedin1.3.31.3.7ResultingHAZARDOUSSITUATIONSandHARMSa)Nohumidification→impropertreatmentb)ToomuchO2administeredovertime–i.e.noCO2contentforbreathingresponsec)Ineffectivetherapye.g.forCOPDifAirratherthanO2administered/Hypoxiad)Introducingcontaminantstothebodye)Usedwithpatientswhosesupraglotticairwayshavebeenbypassed1.3.8PreliminaryreviewoftheUSERINTERFACEconceptNote:Thisreviewcouldbeconductedutilizingacombinationofcognitivewalkthroughs,mock-uptestingandearlyprototypetesting.a)Connectionintoappropriateoxygenflowmeter:-Flowmeterslabelled&body/knobcolourcoded(black–AIR;White–Oxygen)Conclusion:Noissuesb)Connectingpatienttubing/facemaskfromflowmeter:-CouldsupplyAirtopatientratherthanOxygenorviceversa-OperatingoutsiderecommendedflowrateConclusion:Trainingissuec)Preparinguse:-Easytoassemble/disassemble-Fillingtomaximumlevelwithwater-DetailedoperatingfunctionininstructionsConclusion:noissuesd)Readingdisplay:-Fontandlinesclearlylegible-Instructionsonbottle)Conclusion:noissuese)Cleaning:-Canbeautoclaved -Easyvisualidentificationofcontaminatedsurfaces-SurfacefinishessmoothConclusion:noissuesf)Removingfromgassource/flowmeter-Requiresunscrewingfromflowmeter-StraightforwardprocedureConclusion:noissues2USABILITYSPECIFICATION2.1Generala)MEDICALDEVICEBubbleHumidifier–H110b)Basis:-Intendeduse,see1.1-Possibleuseerrors,see1.3.3-Hazardoussituationsorharmsrelatedtouse,see1.3.7-ContextofuseoPatientattaches/un-attachesfacemaskconnectedtogassource–flowmeter/humidifierassembly-PreliminaryusescenariosoPatientsearchesforfacemask/tubingconnectedtoflowmeter/humidifierassemblybybedTerminalUnit(TU)oOperatesattachedflowmeterindependently2.2USESCENARIOSWorstcasescenariostoprovideabasisforvalidationwithpatient=usera)Breathinghumidifiedoxygeninbed:-user/patient=adult-aloneinroom,notsupervised-lyinginbedorinchairbybed-operatesflowmetercontrolknob-breathesthroughattachedfacemask/tubing-pullsoutnasalcannula-ignitionsource/materials-allowswatertorunout2.3USERactionsrelatedtoPRIMARYOPERATINGFUNCTIONSa)Turningattachedflowmeteron/offb)Placingconnectedfacemaskcorrectlyovernose/mouthorcannulainnosec)Observeswaterlevel–readingresultd)Cleaningdeviceafterusee)Arrangingservicingasnecessary(PPM)f)Removingdevicefromgassource/flowmeterg)Storingdevicecorrectlywhenremoved(stores/EBME)2.4USERINTERFACErequirementsforthePRIMARYOPERATINGFUNCTIONSa)Connectiontogassource/flowmeter:-easyconnectiontoflowmeterwithonehand-indicationonbottleinstructions(label)nottousewithpatientswhosesupraglotticairwayshavebeenbypassedb)Fillingwithwater-easytofillc)Readingdisplay:-scaleandbobbinclearlyvisibleunderconditionsofvisibility,see1.1.2.5-minimumandmaximumlevelindicated-textonbottleforcorrectflowrated)Surfaceandmaterial:-bodyimpactstrength80kJ/m2(NotchedCharpy)-smoothsurfacesforeasycleaninge)Holdingpart:-bottleheight104mm-bottlewidth76mmf)Measuringpart:-smoothtranslucentsurface–waterleveleasilyvisibleg)Cleaning:-canbeautoclaved-smoothsurfacesforeasyaccessh)Storage:-shouldbekeptincleanplasticbag(assupplied)i)AccompanyingDocument–issuestobeaddressed:-noleakageallowed-nogreaseoroiltobeused-nottobeexposedtonakedflamesorradiantheatsource-fillwithwatertomaximumlevelbeforeconnectingtogassupply/flowmeter-donotuseifdamaged-alwayscarryoutInspectionpriortouse2.5USERINTERFACErequirementsforthoseUSESCENARIOSthataremostfrequentorrelatedtoSAFETYa)Thewholesettingandmeasurementprocedureshallbeeasytodoafterreadingtheaccompanyingdocument-connectingtoflowmeter-fillingtocorrectlevel-readingwaterlevelscale