Beijing M and B Electronic Instruments MB-MSA100 Part 15 Class B Computing Device Peripheral User Manual

Beijing M&B; Electronic Instruments Co., LTD Part 15 Class B Computing Device Peripheral

User Manual

BeijingM&BElectronicInstrumentsCo.,Ltd.May2016MSA100PeakFlowMeterInstructionManualVersion:V1.9PLEASEREADALLOFTHEINFORMATIONINTHEPACKAGEINSERTBEFOREUSINGTHEPEAKFLOWMETER. IFYOUDONOTUNDERSTANDTHEINSTRUCTIONS,CONSULTM&B,CALL(+86)1061253803(WorkingTime:fromMondaytoFriday,8:30~17:30),ORWRITETOmarket@mbelec.com.
MSA100PeakFlowMeterInstructionManualV1.9 IDate MeasurementsRecommendationSignatureofthephysicianPEFFEV1                                                               
MSA100PeakFlowMeterInstructionManualV1.9 IIAboutthismanualFirstly,thankyouverymuchforusingourM&Bproduct.ToensurecorrectuseofMSA100PeakFlowMeter(hereinbelowmentionedasMSA100orPeakFlowMeterortheMeter),readthefollowingpointscarefullyandadheretothem.Afterreadingthismanual,keepitinasafeplacewhereitcanbereferredtoanytimeaquestionarises.ModelNumber:MSA100ProductName:PeakFlowMeterManufacturer:BeijingM&BElectronicInstrumentsCo.,Ltd.Address:Room6319,Building1,No.27,YongwangRoad,DaxingBioengineeringandMedicineIndustryBase,ZhongguancunSciencePark,DaxingDistrict,BeijingIssueddate:May2016,Version:V1.9IntellectualpropertyTheintellectualpropertyofMSA100anditsmanualbelongtoBeijingM&BElectronicInstrumentsCo.,Ltd.(hereinbelowmentionedasM&B).Copying,reproductionortranslationofalloranypartofthecontentsofthismanualwithoutM&B’spermissionisstrictlyprohibited.AllrightsreservedbyM&B.StatementM&Bhasthefinalrightstointerpretationforthismanual.M&Bisresponsiblefortheproduct’ssafety,reliabilityandperformanceifbelowconditionsaresatisfied: Assembly,extensions,modificationsorrepairarecarriedoutbypersonsauthorizedbyM&B. TheotherrelatedelectricalequipmentusedtogetherwiththeMeterconformstoCEstandards. MSA100isusedinaccordancewiththeinstructionsmanual.MaintenanceServiceFreeservicerange: FreeservicesareofferedinaccordancewithM&Bwarrantyregulations.Feebasedservicerange:
MSA100PeakFlowMeterInstructionManualV1.9 III BeyondM&Bwarrantyregulations. Duringthewarrantyperiod,warrantyshallnotextendtothefollowingconditions:1) Itisdamagedfromimproperuse.2) Batteryvoltageisbeyondthescopeofproductspecification.3) Naturaldisasters.4) Replacedaccessories,consumableswithoutM&Bauthorization.5) ModificationorrepairbyanyoneexceptforBeijingM&Bauthorizedpersonorcompany.ContactusServicetelephoneandproductsupport:PleasecontactM&Bifyouhaveanyquestionsregardingproductsupport.+86‐10‐61253803(WorkingTime:Monday~Friday，8:30~17:30);Orcontacttheregionalservicepartnerordistributor.OrderconsumablesandrepairpartsPleasepurchaserepairparts(mouthpieceetc.)fromtheM&Bservicepartnerordistributorinyourcountry.OtherquestionsPleasecontactusasbeloworvisitourwebsite：www.mbelec.com.HeadquartersCompany:BeijingM&BElectronicInstrumentsCo.,Ltd.Address:Room6319,Building1,No.27,YongwangRoad,DaxingBioengineeringandMedicineIndustryBase,ZhongguancunSciencePark,DaxingDistrict,BeijingInformationforTheEuropeanUnionrepresentative:EuropeanUnionRepresentativeName:ShanghaiInternationalHoldingCorp.GmbH(Europe).EuropeanUnionRepresentativeAddress:Eiffestrasse80,20537Hamburg,Germany.
MSA100PeakFlowMeterInstructionManualV1.9 IVCAUTION:Whenthepeakflowmeterisusedtowatchlungconditionssuchasasthma,theusershouldbeunderthecareofaphysicianorotherlicensedhealthcareprofessional.Alicensedhealthcareprofessional’sadviceisrequiredtounderstandthemeaningandimportanceofthemeasuresyougetwithyourpeakflowmeterandtodecideonanappropriatetreatmentplan.Thetreatmentplangiventoyoubyyourphysicianorotherlicensedhealthcareprofessionalwilltellyouwhatactiontotakewhentherearechangesinyourpeakflownumber.Nomatterwhatyourpeakflowmeasuresare,ifyouhavesignsandsymptomssuchaschesttightness,shortnessofbreath,coughingorwheezingyoushouldfollowyourlicensedhealthcareprofessional’sadviceforcontactinghimorher.Instructionsforusingthepeakflowmetermustbefollowedcarefullyinordertogetcorrectmeasureofairflow.Ifyouareunabletoobtainareadingyoushouldcontactyourphysicianimmediately.Thepeakflowmetershouldnotbeusedbymorethanoneperson.Ifyouhaveanyquestionsaboutyourpeakflowmeteranditsuse,talktoyourlicensedhealthcareprofessional.
MSA100PeakFlowMeterInstructionManualV1.9 IContent1BRIEFINSTRUCTION.....................................................................................................................................‐1‐1.1FunctionDescription........................................................................................................................‐1‐1.2IntendedUse....................................................................................................................................‐1‐1.3IndicationsforUse...........................................................................................................................‐2‐1.4MeasuringPrinciple.........................................................................................................................‐2‐1.5Step‐by‐stepInstructions...............................................................................................................‐2‐1.6TechnicalSpecification.....................................................................................................................‐3‐1.7OtherSpecification..........................................................................................................................‐3‐1.8CompositionofPackage..................................................................................................................‐3‐1.9TransportationandStorageConditions..........................................................................................‐4‐1.10OperatingCondition........................................................................................................................‐4‐1.11DeviceComposition.........................................................................................................................‐4‐2SAFETYPRECAUTIONS.................................................................................................................................‐5‐2.1SafetyInformation...........................................................................................................................‐5‐2.1.1TermsandSymbols..............................................................................................................‐5‐2.1.2Environment.........................................................................................................................‐5‐2.1.3Preparation..........................................................................................................................‐5‐2.1.4OtherNotices.......................................................................................................................‐5‐2.2TransportationandStorage.............................................................................................................‐6‐2.3InterferenceInstruction...................................................................................................................‐6‐2.4Classification....................................................................................................................................‐6‐2.5SafeOperationandProcessingConditions.....................................................................................‐6‐2.6StandardsandRegulationCompliance...........................................................................................‐7‐3MAINTENANCE............................................................................................................................................‐8‐3.1BatteryAssemblage.........................................................................................................................‐8‐3.2AssembleMouthpieceandTurbineintoMainUnit.......................................................................‐8‐3.3Cleaning............................................................................................................................................‐8‐4OPERATION................................................................................................................................................‐10‐4.1LCDScreenDisplayIntroduction...................................................................................................‐10‐4.2FirstTimeUse................................................................................................................................‐11‐4.3TimeSetting...................................................................................................................................‐11‐4.4Poweron/Poweroff......................................................................................................................‐12‐4.5Measuring......................................................................................................................................‐12‐4.6ImportantInformationforMeasuringandMonitoringofPeakFlowValues..............................‐14‐4.7SimpleAssessment(TrafficLightScheme)....................................................................................‐16‐4.8RecordsPlayback...........................................................................................................................‐16‐4.9Deleterecords................................................................................................................................‐17‐4.10DataTransmission..........................................................................................................................‐17‐5TROUBLESHOOTING..................................................................................................................................‐17‐6GUIDANCEANDMANUFACTURE’SDECLARATIONS.................................................................................‐19‐7TECHNICALSPECIFICATION........................................................................................................................‐22‐
MSA100PeakFlowMeterInstructionManualV1.9 ‐1‐1 BRIEFINSTRUCTION1.1 FunctionDescriptionMSA100PeakFlowMeterisahand‐heldpulmonaryfunctionmeasuringmedicaldevicethatmeasuresyourmaximumpossibleexhalationwhichiscalledpeakexpiratoryflow(PEF)andforcedexpiratoryvolumein1second(FEV1).TheaccuracymeetsAmericanThoracicSociety(ATS)Standard2005Revision.Apeakflowmeterisusedtomeasureaperson’s“peakexpiratoryflow”,whichisasimplemeasureofairflowthatcantellyouhowwellyouarebreathing.Ittellsyouhowwellairismovingthroughtheairwaysinyourlungs.ForcedExpiratoryVolume(FEV1)isameasureofthevolumeofairexpelledin1second.Ifyouhaveabreathingconditionsuchasasthma,C.O.P.D.,orchronicbronchitis,yourphysician(orotherlicensedhealthcareprofessional)mayrecommendthatyouuseapeakflowmetertowatchforchangesinyourairflow.Yourphysician(orlicensedhealthcareprofessional)willgiveyouatreatmentplanthatwilltellyouwhatactionstotakewhenyouhaveachangeinairflow.Inaddition,youshouldrecordyourpeakflowmeasuresasrecommendedbyyourphysician(orotherlicensedhealthcareprofessional).Reviewingpeakflowmeasurescanhelpyouandyourphysician(orlicensedhealthcareprofessional)checkscloselyonyourasthmaorC.O.P.D.toprovidethebesttreatmentforyou.MSA100issuitableforchildrenthroughadultswhoarecapableoffollowingtheinstructionsforuse.BecausetheMeterhasanautomaticmemorythreehundredsreadings,youcantaketheMeterwithyouthenexttimeyouvisityourdoctorforareviewofmanyreadings.Thedoctormakesanappropriatetreatmentplanbasedonthem,andhelpspatientstorecuperatehealth.MSA100PeakFlowMetersupportsUSBconnection.Whenmeasurementrecordsadduptomaximumvolume,youcantransfertherecordstoPCviaUSB.Thenusingsoftwaretohelpsaveandtrackforlongterm.Thepeakflowmetershouldnotbeusedbymorethanoneperson.1.2 IntendedUseMSA100isintendedformonitoringPEF(PeakExpiredFlowRate)andFEV1(ForcedExpiratoryVolume)forpatientuseathome.Thedeviceisdesignedforpediatrictoadultpatients.WhentheMeterisusedtomonitorlungconditionssuchasasthmaorC.O.P.D.,theusershouldbeunderthe
MSA100PeakFlowMeterInstructionManualV1.9‐2‐careofalicensedhealthcareprofessional.Alicensedhealthcareprofessional’sadviceisrequiredtounderstandthemeaningandimportanceofmeasurementsreportedbytheMeterandhowtodecideonanappropriatetreatmentplan.Thistreatmentplanwilltellthepatientwhatactiontotakewhentherearechangesintheirpeakflowmeasurements.1.3 IndicationsforUseThisdeviceisintendedformonitoringPEF(PeakExpiredFlowRate)andFEV1(ForcedExpiratoryVolumeinonesecond)forpatienthomeuse.Thedeviceisdesignedforpediatrictoadultpatients.Thedeviceisintendedformonitoringrespiratoryconditionssuchasasthma.1.4 MeasuringPrincipleWhenairflowpassesthroughturbinesensor,itmakestheleafofturbinerotate.Rotaryspeedoftheleafislinearrelationshipwithairflowrate.Bythetechnologyofphotoelectricconversion,turningoftheleafisconvertedtobepulsesignal,whichisprocessedbythemaincontrolleraftersampling.ThePEFandFEV1valuearecalculatedbyanalgorithmformulaanddisplayedontheLCD.1.5 Step‐by‐stepInstructionsPLEASEREADALLOFTHEINFORMATIONINTHEPACKAGEINSERTBEFOREUSINGTHEPEAKFLOWMETER. IFYOUDONOTUNDERSTANDTHEINSTRUCTIONS,CONSULTM&B,CALL(+86)1061253803(WorkingTime:fromMondaytoFriday,8:30~17:30),ORWRITETOmarket@mbelec.com.ASKYOURPHXSICIANOROTHERLICENSEDHEALTHCAREPROFESSIONALTOWATCHYOUUSETHEPEAKFlOWMETER.THISWILLHELPASSURETHATYOUAREUSINGITCORRECTLY.NOMATTERWHATYOURPEAKFLOWMEASURESARE,IFYOUHAVESIGNSANDSYMPTOMSSUCHASCHESTTIGHTNESS,SHORTNESSOFBREATH,COUGHINGORWHEEZINGYOUSHOULDFOLLOWYOURLICENSEDHEALTHCAREPROFESSIONAL'SADVICEFORCONTACTINGHIMORHER.IFYOUAREUNABLETOOBTAINAREADINGYOUSHOULDCONTACTYOURPHYSICIANIMMEDIATELY.a. Getthepeakflowmeterready(takeoutofcase,insertmouthpiece,positionindicator;directionswilldifferaccordingtodevice)b. Standupc. Takeadeepbreathin
MSA100PeakFlowMeterInstructionManualV1.9‐3‐d. Placethemeterinthemouthandcloselipsaroundthemouthpiece.Makesureyourlipsformatightsealaroundthemouthpiece.Donotputyourtongueintothemouthpiece.Donotbendyourneck.e. Blowoutashardandfastasyoucan.f. Readthenumbernexttotheindicator.Thisisyourpeakflowmeasure.Writeitdown.g. Afteryoumovetheindicatorbacktozero,repeatthestepstwomoretimestogettwomorepeakflowmeasures.h. Choosethehighestnumberofyourthreepeakflowmeasures.Writethenumberinyour“PeakPlowDiary."Directionsforthediaryarewrittenonthediary.i. Howtostoreyourpeakflowmeter(directionswilldifferaccordingtodevice).1.6 TechnicalSpecification1. MeasuringmethodFlow：TurbinesensorVolume：FlowIntegration2. MeasuringrangVolume：0.01L~9.99LFlow：50L/min~900L/min3. AccuracyVolume：±3%or±0.05L,whicheverisgreaterFlow：±10%or±20L/min,whicheverisgreater4. Display：Segmentliquidcrystaldisplay5. Memory：300measurementswithdataandtime1.7 OtherSpecificationTypeBappliedpart.CautionModel：MSA100Powersource：AAA1.5V×2alkalinebatteries1.8 CompositionofPackageNo.NameUnitQuantityNote1Mainequipmentpiece1MSA100
MSA100PeakFlowMeterInstructionManualV1.9‐4‐2Turbinesensorpiece13Mouthpiecepiece14Instructionmanualpiece15USBcablepiece11.9 TransportationandStorageConditions1. Environmenttemperatureof‐10degC~+55degC;2. Relativehumidityof≤93%;3. Atmosphericpressureof500hPa~1060hPa.1.10 OperatingCondition1. Environmenttemperatureof+10DegC~+40DegC;2. Relativehumidityof25%~85%;3. Atmosphericpressureof860hPa~1060hPa.1.11 DeviceCompositionMSA100PeakFlowMeterisdividedintopartsbelowlikeFigure1‐1.1. Mainequipment.2. AAA1.5×2alkalinebatteries.3. Mouthpieceandturbinesensor.Figure1‐1Make‐upofMSA100PeakFlowMeter
MSA100PeakFlowMeterInstructionManualV1.9 ‐5‐2 SAFETYPRECAUTIONS2.1 SafetyInformation2.1.1 TermsandSymbolsAsthemanufacturerofmedicaldevices,thecompanystrivestoensurethesecurity,reliabilityandperformanceoftheinstrument.Forcorrectuseofthisinstrument,readthefollowingpointscarefullyandadheretothem.Afterreadingthismanual,keepitinasafeplacewhereitcanbereferredtoanytimeaquestionarises.2.1.1.1 TermsandDefinitionThismanualisusingthetermof"ATTENTION",etc.frombeginningtoend,whichaimstoindicatethedangerandspecifiedseveritydegreeorlevel.Pleasebefamiliarwithitsdefinitionandimportance.ATTENTION:Denotespotentialdangerorunsafetreatmentwhichmayresultinslightinjuryordamagetothedeviceorotherproperty.Thenoteprovidesapplicationhintsorotherusefulinformation.Readthenotecarefullytoensuresafeandcorrectuse.2.1.1.2 ExplanationofSafetySymbolsSymbolsExplanationDenotesanoteorwarningcontent;Denotesaprohibitedoperation.Theoperationmustneverbeperformed;Performtheoperationaccurately.Theinstructionmustbestrictlyadheredto.2.1.2 EnvironmentATTENTION:AmbienttemperatureexceedingtherangeoftechnicalspecificationwillaffecttheMeter’saccuracy,whichwillcausethemachinedamagedormachinelifereduced.2.1.3 PreparationATTENTION:Beforeusingthedevice,operatormustverifywhetherworkproceduresandconditionsareappropriatefortheuseofthisinstrument.2.1.4 OtherNotices
MSA100PeakFlowMeterInstructionManualV1.9‐6‐ATTENTION:Inordertoavoidelectricshockordetectorfailure,donotallowanyliquidtopermeateintothedevice.Ifliquidhaspermeatedintoit,pleasecontactyourlocalservicepartnerordistributorofM&Btoinspectthemeter.ATTENTION:Donotusethedetectornearflammableanestheticgases,steamorliquid.ATTENTION:Forsafeoperationofthedevice,theusermustfollowthisinstructionmanual.However,theseinstructionsdonotsupersedeestablishedmedicalproceduresconcerningrespiratorysystemexamination.ATTENTION:Donotreplaceaccessories,consumableswithoutM&Bauthorization.2.2 TransportationandStorageATTENTION:PuttheMeterintothespecifiedstoragecaseduringtransportation.2.3 InterferenceInstructionATTENTION:TheMSA100hasfunctionsthatitdoesnotaffectnormaloperationofotherdevices,orisnotaffectedbyotherdevices.2.4 ClassificationTypeofprotectionagainstelectricshockInternalpowerdeviceDegreeofprotectionagainstelectricshockTypeBappliedpartDegreeofprotectionagainstliquidpenetrationIP22,Protectedagainstsolidforeignobjectsof12,5mm∅andgreaterandProtectionagainstverticallyfallingwaterdropswhenENCLOSUREtiltedupto15°ATTENTION:Theclassificationoftheelectricalshock,firedisaster,machineryandotherspecialrisksisdoneaccordingtoEN60601‐1.2.5 SafeOperationandProcessingConditionsThesterilizationordisinfectionmethodrecommendbymanufacturerNotapplicableElectromagneticinterferenceAvoidtheusingofwirelesstelephonesorotherstronginterferenceequipmentneartheMeter
MSA100PeakFlowMeterInstructionManualV1.9‐7‐WorkModeIntervalElectricsurgicalinterferencedamageNodamageM&BElectronicInstrumentsCo.,LtddoesnotacceptliabilityorresponsibilityforincorrectuseoroperationoftheMSA100.ATTENTION:Ifindoubt,consultyourPhysicianorHealthcareexpertATTENTION:Nomodificationofthisequipmentisallowed.ATTENTION:Donotmodifythisequipmentwithoutauthorizationofthemanufacturer.ATTENTION:Ifthisequipmentismodified,appropriateinspectionandtestingmustbeconductedtoensurecontinuedsafeuseoftheequipment.2.6 StandardsandRegulationComplianceEN60601‐1‐2006:MedicalElectricalEquipment‐GeneralRequirementsforSafety;IEC60601‐1‐2‐2004:MedicalElectricalEquipment‐SafetyRequirements‐EMC;ATSStandardizationsofspirometry2005Revision.
MSA100PeakFlowMeterInstructionManualV1.9 ‐8‐3 MAINTENANCE3.1 BatteryAssemblageShowasfiguire3‐1,slidethecoverdown,inserttwoAAAbatteriesintheshellfollowingsymbolinside,andclosethecover.Figure3‐1MSA1000batteryassembleATTENTION:IfdonotuseMeterforlongtime,pleasetakeoutbatteriesfrombatterycasetoavoidbatteryleakage.ATTENTION:Pleaseselectbatterieswithregularfactoryinsteadoffakeandshoddybatteries.3.2 AssembleMouthpieceandTurbineintoMainUnit.Insertmouthpiecetoturbinesensor,thentheassemblageofmouthpieceandturbinescrewclockwiseintomainunit.Seetheprocedureatfigure3‐2.Figure3‐2Assemblemouthpieceandturbine3.3 Cleaning
MSA100PeakFlowMeterInstructionManualV1.9‐9‐ATTENTION:Pleasecleanmouthpiecewhenfirsttimeuse,preventfromdustbecauseoftransportorstorage.TheMetershouldbecleanedwithin30minutesaftereachuse.Separatemouthpieceandturbinefrommainbody.Disconnectmouthpieceandturbine.Immersethemouthpieceandturbineinapreparedsoapsolution.Cleanthoroughlybyswirling.Thoroughlyrinsethemouthpiecewithwater(distilledwaterisrecommended).Allowthedevicetoairdry.Figure3‐3DisassembleturbineandmouthpieceATTENTION:Don’tusehighpressurewaterorrunningwatertorinseturbine,whichmaybeleadtodamageturbine,andmakeaccuracydeteriorative.Don’tuseboilingwatertorinseturbine.Whendried,assemblemouthpieceandturbine,andinsertitintomainunit.UsecleananddampclothcleanmainbodyofMSA100,butneverputmainbodyintowater.Showasfigure3‐4.Figure3‐4cleaningtomainunit
MSA100PeakFlowMeterInstructionManualV1.9 ‐10‐4 OPERATION4.1 LCDScreenDisplayIntroductionFigure4‐1LCDdemonstrationFigure4‐1showsallsegmentofLCDdisplaying,andthecharactersandsymbolsmeaningisdescribedbelow.:Fourrowsdigitdisplay,indicatingindividuallydate,time,measurementvalue,andrecordnumber.Day:Indicatenoworhistoricalmeasurementrecordday.Month:Indicatenoworhistoricalmeasurementrecordmonth.T:Indicatenoworhistoricalmeasurementrecordtime.Y:Indicatenoworhistoricalmeasurementrecordyear.AM:Indicatenoworhistoricalmeasurementrecordtimeisbefore12:00.PM:Indicatenoworhistoricalmeasurementrecordtimeisafter12:00.PEF:IndicatenoworhistoricalmeasurementPEFvalue.FEV1:IndicatenoworhistoricalmeasurementFEV1value.:SymbolofinsufficientbatteryvolumeL/min:UnitofPEFvalue.L:UnitofFEV1value.MR:RecordsnumberorID.:Indicatortotrafficcolouroutsidesurfaceofmainunit,thepositionofarrowmeansthedegreeofPEFnormalordeclined.
MSA100PeakFlowMeterInstructionManualV1.9‐11‐:IndicateUSBcablehasconnected，andtherecordscanberead.4.2 FirstTimeUseFirstlyassemblemouthpieceandturbineaccordingsection3.2.Secondlyinsertbatteriesaccordingtosection3.1.PoweronMSA100,themainunitenterstimesettingstate.4.3 TimeSettingAfternewbatterieshavebeeninserted,theLCDdisplayisshownasfigure4‐2.Whiletheyear“2012”isblinking,itindicatestheyearwaitingforsetting.Systemdefaultsettingisyear:2012,month:1,day:1,time12:00amo’clock.Assumetargetyearis2013,settingmethodsarebelow.Figure4‐2InitialdisplayafterpoweronPressleftkeyorrightkeytochangeyear.Ifpressleftkeyonce,theyeardisplayingdecrease1.Ifpressrightkeyonce,theyeardisplayingincrease1.Set2013,youshouldpressrightkeyonce.Thenpresspower/confirmkeyonceturntonextsetting,shownasfigure4‐3.Pleasenote:ifyouholddownthekeymorethan2seconds,itspeedsup.ATTENTION:Ifdateandtimeisnotset,youcan’tusetomeasure.Ifdateandtimeisnotsetcorrectly,yourrecordsdatemaybewronglater,whichwillmakehistoricalrecordtimeincorrect.
MSA100PeakFlowMeterInstructionManualV1.9‐12‐Figure4‐3yearsettingNowtheyearcharactersarenotblinking,meaningtheyearhassetover.Followingthemonth“1”beginsblinking,youshouldsetmonth.Thesettingwaylikemonth,day,hourandminute,isthesameasthatofyear.Whenalldateandtimeissetover,thedeviceentersintomeasurestatus.4.4 Poweron/PoweroffWiththemeteroff,presspower/confirmkeyonce;themeterwillpoweron.Withthemeteron,presspower/confirmkeyuntilthebuzzerbeginbeep,thenreleasethekey,themeterwillpoweroff.Beforethemeterswitchesoff,thehighestvalesofthecurrentmeasurementsessionanditsrelatedmemoryposition“MRXXX”isdisplayed.Afterpoweron,thesystemcankeepactivestatuswithinoneminute,thenitwillpoweroffautomatically.Ifpressanykeyormeasureoncemore,thesystemwillprolong1minutetopoweroff.4.5 MeasuringWhenthesystempoweron,thelastresultisshown,andthenthedeviceindicates“READY”forameasurementbytwoshortbeeps.Inhalecompletelyandholdyourbreathformoment.Coverthemouthpiecetightlywithyourlips.Blowintoturbineashardandasfastasyoucan.Showasfigure4‐4.Alongbeepconfirmsthattheresultisrecorded.PEFisdisplayedforabout3secondsfollowedbyFEV1andthenthemonitorisreadyforanewmeasurementwhichisindicatedbytwoshortbeeps.Showasfigure4‐5.Itisrecommendedtoperformthreeormoremeasurementssequentially.Thedeviceshallmemorythebestvalueasthetestresult.Aftereachmeasurement,atfirsttheactualreadingisshowninthedisplayandthenitswitchesautomaticallytothehighestreadingofyourcurrentmeasurementsession.
MSA100PeakFlowMeterInstructionManualV1.9‐13‐StoretheMeterinacleananddustfreeplace.ATTENTION:Askyourphysician(orotherlicensedhealthcareprofessional’s)towatchyouusethispeakflowmeterbeforeyourelyonanymeasurements.Readallinformationinthisinstructionbookletbeforeusing.ContactM&Bat800‐810‐0520,+8601061253747、+8601061253716‐8020、+8601061253716‐8001/80028AM‐5PMMonday–Fridaywithquestions;orcontactwithM&Bservicepartnerordistributor.ATTENTION:Ifyouhavesignsandsymptomssuchaschesttightness,shortnessofbreath,coughingorwheezingfollowyourphysician’s(orotherlicensedhealthcareprofessional’s)adviceforcontactingthemnomatterwhatreadingsyouobtain.Ifyoudonotgetareadingcontactsyourphysicianimmediately.ATTENTION:DonotmeasurePEFandFEV1understrongsunlight.Figure4‐4PeakexpiremeasuringmethodFigure4‐5PEFandFEV1measurementvaluedisplayPleasenote:MSA100savesthehighestPEFreadingfromswitchingthedeviceonuntil
MSA100PeakFlowMeterInstructionManualV1.9‐14‐switchingthedeviceoff.4.6 ImportantInformationforMeasuringandMonitoringofPeakFlowValuesItisimportanttoregularlymonitoryourpeakflowvalues.Doctorsgenerallyrecommendtakingonemeasurementinthemorningandoneintheevening,everydaynormallybeforeinhalingyourprescribeddrugs.Carryoutadditionalmeasurementwheneveryoufeelunwellorperceiveshortnessofbreath.Pleasenotethatasthmaattacksareindicatedinadvancebylowpeakflowvaluesbeforeyoufeelit!Pleasecontactyourdoctorincasessuchasthese.Alsodosoifyouhavesignsandsymptomssuchaschesttightness,shortnessofbreathcoughingorwheezing.Self‐measurementmeanscontrol,notdiagnosisortreatment.Inanyevent,pleasebesuretodiscussyourmeasuredvalueswithyourdoctor.Yourdoctorwillalsoexplainwhichvaluesarenormalforyou.Youshouldneveralterthedosagesofanymedicationwithouttalkingtoyourdoctor.Pleasenotethatthedevicestoresupto300measuredvalueswithdateandtime.Whenthememoryisfull,shownasfigure4‐5,eraseallrecordsyourself,orvisityourdoctorintime,lethe/shetoanalyzeyourdata.Pleaseconfirmthatdateandtimesettingsarealwaysactual.DonotmeasurePEFandFEV1underoutdoorstrongsunlight.TheperformanceoftheMetercanbeaffectedbyextremesoftemperatureandhumidity.Pleasereferto“technicalspecifications”fordetails.*Table4‐1NormalPEFvaluesforMales(Caucasian‐American)AgeHeight(cm)(Years) 120130 140 150 160 170 180 190200817120824929233938844149655410 18522226230635240245451056815 24628332436741446351657162920 34738442546851556461667273025 35439243247552257162467973830 357395 43547952557562768274135 35739443547852557462668274040 35239043047452057062267773645 34438242246551256161466972750 332369410453500549601657715
MSA100PeakFlowMeterInstructionManualV1.9‐15‐55 31635339443748353358564169960 29633337341746351356562167965 27230934939343948954159765570 24428132236541146151356962775 21224929033338042948253759580 17621425429834439344650156085 13717421525830435440646252090 93131171215261310363418477*Table4‐2NormalPEFvalueforFemales(Caucasian‐American)AgeHeight(cm)(Years) 120130 140 150 160 170 180 1902008170198228261 29533237141345610 20723526529733236940844949315 26229032035338742446350554820 27530333336540043747651756125 28231034037240744448352456830 28631334437641144848752857235 28631434437741144848752957240 28431234237440944648552657045 27830633636940344047952156450 27029832836039543247151255655 25828631634938342045950154460 24327130133436840544448652965 22525328331635138742746851170 20423226329533036640644749075 18020823827130534238142346680 15318121124427831535439643985 12315118121324828532436540990 90118148180215252291332376*SpirometricReferenceValuesfromaSampleoftheGeneralU.S.Population,JohnL.Hankinson,JohnR.Odencrantz,andKathleenB.Fedan,et.al.,DivisionofRespiratoryDiseaseStudies,NationalInstituteforOccupationalSafetyandHealth,CentersforDiseaseControlandPrevention,Morgantown,WestVirginia,1999.TheThirdNationalHealthAndNutritionExaminationSurvey(NHANESIII).Figure4‐5Memoryisfull
MSA100PeakFlowMeterInstructionManualV1.9‐16‐4.7 SimpleAssessment(TrafficLightScheme)Usinggreen,yellowandredtrafficlighttoexpressthedegreeofyourillnessisastraightway.Greenindicatesillnessisundercontrol,don’trequirehighermedicationdosage.Yellowindicatesyoumustcaution,ifyourmeasuredvaluesfrequentlybelocatedinthisarea,increaseyourmedicationdosageasdiscussedwithyourphysician.Redindicatesitisdangerous.Actasdiscussedwithyourphysicianorseekemergencymedicaltreatment.Simpleassessmentsettingsneedtoconsultwithyourdoctors(orotherlicensedhealthcareprofessional’s).Thegeneralsettingmethodisbelow.(1)MeasureyourpersonalbestvalueusingMSA100,whichisthehighestvalueyouachieveunderoptimumconditions(freeofsymptoms,feelingwell).OrchooseNHANESIIIorothereffectivepredictiontocalculateanormalvalue,itistobeasabestvalue.(2)PressandholdPowerKeyforalongtime,whileinstallthebattery.DonotloosenPowerKey,untilyoucanseepredictedvalueofPEFblinked.Itistrafficlightschemebasicvalueorpredictionvalue.(3)ThenuseRightKeyorLeftKeytoincreaseordecreasevalue,enteryourbestvalueor“normalPEFvalue”shownasTable4,(4)PressPowerKeyonceagain,thendisplay“”,settingsuccesses.(5)Thegreenarealowerlimitusuallyreachesupto80%ofthepredictedvalue,theyellowarealowerlimitusuallyreachesupto50%ofthepredictedvalue,thepercentisnotallowedtoedit,anditisdefaultintheMeter.4.8 RecordsPlaybackWhenthesystementersintomeasuringstatus,presskeyleftorright,youcanwatchhistoricalrecords.Ifyoukeeppressingthebuttonyoucanmovequicklythroughtherecords.Atthesametimerecordnumberwillrefreshwithincreasingordecreasingnumber.Therecordscontainmeasureddate,time,PEFvalue,FEV1valueandpositioninmemory.Presspower/confirmkeyonceorwaitthecurrentrecorddisplayover,thesystemwillentersintomeasuringstate.
MSA100PeakFlowMeterInstructionManualV1.9‐17‐Figure4‐6Recordsplayback4.9 DeleterecordsInmeasuringstatuspressleftandrightkeyforfivesecondslong,andallrecordswillbedeleted.Thehintafterdeletedisshownasfigure4‐7.Figure4‐7Allrecordshasdeleted4.10 DataTransmissionMSA100cantransmitmeasuredrecordstoPCviaUSB.Allrecordscouldbeplaybackandstatisticallyanalyzed.WhenMSA100isconnectedwithPC,MSA100displays“”.ATTENTION:  Thisfunctionisoptional,youmayaskdistributorfordetail.5 TROUBLESHOOTINGMessageCauseRemedyThePEFresultishigherthan900L/min,orFEV1resultishigherthan9.99Lthisisaverygoodresult
MSA100PeakFlowMeterInstructionManualV1.9‐18‐Meansrecordsaddressexceedslimit,orrecorddateandtimeiserror,orsoftwareisfailureRestartsystemRecordsdonotexistnorecordsMemoryisfullItisbettertodeleterecords,ornewrecordisnotstoredbatteryinsufficientItisbettertochangenewbatteriesNOdisplayonscreenBatteryislow,orbatterypoleisreversed. Changenewbatteries,andnotepoledirectionMeasuringvalueerrorInspectwhethertheleafofturbineisrunfreely.Andtheleafisdirty.OrconsultwhetherthevalueisnormalwithyourdoctorOtherquestionpleasecontactwithM&Bservicepartnerordistributor.
MSA100PeakFlowMeterInstructionManualV1.9 ‐19‐6 GUIDANCEANDMANUFACTURE’SDECLARATIONSElectromagneticEmissionsTheMSA100peakflowmeterisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerortheuserofthedeviceshouldensurethatitisusedinsuchanenvironment.EmissionstestComplianceElectromagneticenvironment–guidanceRFemissionsCISPR11Group1TheMSA100peakflowmeterdetectorusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipment.RFemissionsCISPR11 ClassBTheMSA100peakflowmeterdetectorissuitableforuseinallestablishments,otherthandomesticestablishmentsandpowersupplyisinternal.ElectromagneticImmunityTheMSA100peakflowmeterdetectorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerortheuserofthedeviceshouldensurethatitisusedinsuchanenvironment.ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment–guidanceElectrostaticdischarge(ESD)IEC61000‐4‐2±2kVcontact±4kVcontact±6kVcontact±8kVcontact±2kVair±4kVair±8kVair±15kVair±2kVcontact±4kVcontact±6kVcontact±8kVcontact±2kVair±4kVair±8kVair±15kVairFloorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.Powerfrequency(50/60Hz)magneticfieldIEC61000‐4‐810A/m 10A/mPowerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.RadiatedRFIEC61000‐4‐33V/m80MHzto2.5GHz3V/m P2.3d  800MHzto2,5GHzwherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)anddistherecommendedseparationdistanceinmeters(m)b.
MSA100PeakFlowMeterInstructionManualV1.9‐20‐FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey,ashouldbelessthanthecompliancelevelineachfrequencyrange.bInterferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichMSA100peakflowmeterdetectorisusedexceedstheapplicableRFcompliancelevelabove,MSA100peakflowmeterdetectorshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingMSA100peakflowmeterdetector.bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.EMCDeclarationWithmanyelectronicdevicessuchasmicrowave,TV,wirelessrouter,PC’s,andmobiles,medicaldevicesinusemaybesusceptibletoelectromagneticinterferencefromthesedevices.Thismayresultinincorrectoperationofthemedicaldeviceandcreateapotentiallyunsafesituation.Medicaldevicesshouldbekeptdistance1mfromthoseelectronicdevices.InordertoregulatetherequirementsforEMCwiththeaimtopreventunsafeproductsituations,theEN60601‐1‐2standardhasbeenimplemented.Thisstandarddefinesthelevelsofimmunitytoelectromagneticinterferencesaswellasmaximumlevelsofelectromagneticemissionsformedicaldevices.MedicaldevicesmanufacturedbyM&BconformtothisEN60601‐1‐2standardforbothimmunityandemissions.Themedicaldevicesshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisunavoidable,themedicaldeviceshouldbeseentooperatenormallyasitshouldinthissituation.FCCDeclarationNote:ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonable
MSA100PeakFlowMeterInstructionManualV1.9‐21‐protectionagainstharmfulinterferenceinaresidentialinstallation.Thisequipmentgenerates,uses,andcanradiateradiofrequencyenergy,andifnotinstalledandusedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowingmeasures:–Reorientorrelocatethereceivingantenna.–Increasetheseparationbetweentheequipmentandreceiver.–Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected.–Consultthedealeroranexperiencedradio/TVtechnicianforhelp.Changesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoidtheuser’sauthoritytooperatetheequipment.ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowingtwoconditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)Thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.
MSA100PeakFlowMeterInstructionManualV1.9 ‐22‐7 TECHNICALSPECIFICATIONMSA100PeakFlowMeterisahandholdpulmonaryfunctionmeasuringmedicaldevicethatmeasuresyourmaximumpossibleexhalationwhichiscalledpeakexpiratoryflow(PEF)andforcedexpiratoryvolumein1second(FEV1).TheparametersaredisplayedontheLCDscreen.MSA100alsocanrecordmeasurementsupto300pieces,andsupportsUSBconnection.Whenmeasurementrecordsadduptomaximumorotherpatientwoulduse,youcantransfertherecordstoPCviaUSB,thenasoftwarehelptosaveandtrackforlongtime.GeneralSensortypeTurbineMeasurementparametersFEV1/PEFMemorysize300BTPSPEFandFEV1resultsdisplayedatBTPSconditionsAccuracyMeetATS2005RevisionaccuracyrequirementVolumerange0.01L~9.99LAirflowrange50L/min~900L/minVolumeaccuracy±0.050Lor±3%Airflowaccuracy±10%or±20L/minResolutionVolumeresolution0.01LAirflowresolution 1L/minResistancetoflowBackpressure@660L/min<0.11KPa/secBackpressure@900L/min<0.15KPa/secRepeatabilityPEF±5%or±10L/minFEV1±3%or±0.05LDisplayscreenSize1.8inchesTypeLCDControlStandardpower/confirmkey,left/rightkeyEnvironmentspecificationPowersource AAA1.5×2batteriesDesignInterval,ordinarydeviceBatteryworktimeMaximumoneyearConnectionWherefitted,USBforPCconnection.RequireaUSB‘A’to‘USB’mini‘B’OperationTemp erat ure Humidity10oC～40oC25%~85%
MSA100PeakFlowMeterInstructionManualV1.9‐23‐Atmosphere860hPa～1060hPaStorageTemp erat ure HumidityAtmosphere‐10oC～55oC15%~93%500hPa～1060hPaZoningGreen/Yellowthreshold80%ofreferenceGreen/Yellowthreshold50%ofreferencePhysicalspecificationHeight12.6centimeterWide5.4centimeterThickness2.8centimeterWeight120g（containbatteriesandmouthpiece）MaintenancewarrantyStandardOneyearOptionProvideotheroptions.ThedetailpleasecontactwithM&Banddistributors.

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