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User Manual | Users Manual | 653.78 KiB | January 07 2016 | |||
| 1 | Cover Letter(s) | January 07 2016 | ||||||
| 1 | External Photos | January 07 2016 | ||||||
| 1 | Internal Photos | January 07 2016 | ||||||
| 1 | ID Label/Location Info | January 07 2016 | ||||||
| 1 | Cover Letter(s) | January 07 2016 | ||||||
| 1 | Test Report | January 07 2016 | ||||||
| 1 | Test Setup Photos | January 07 2016 |
| 1 | User Manual | Users Manual | 653.78 KiB | January 07 2016 |
MSA100PeakFlowMeter InstructionManual Version:V1.9 PLEASEREADALLOFTHEINFORMATIONINTHEPACKAGEINSERTBEFOREUSINGTHEPEAKFLOWMETER. IFYOUDONOTUNDERSTANDTHEINSTRUCTIONS,CONSULTM&B,CALL(+86)1061253803(WorkingTime:
fromMondaytoFriday,8:30~17:30),ORWRITETOmarket@mbelec.com. BeijingM&BElectronicInstrumentsCo.,Ltd. May2016 MSA100PeakFlowMeterInstructionManualV1.9 Date Measurements Recommendation Signatureofthe PEF FEV1 physician I MSA100PeakFlowMeterInstructionManualV1.9 Aboutthismanual Firstly,thankyouverymuchforusingourM&Bproduct. ToensurecorrectuseofMSA100PeakFlowMeter(hereinbelowmentionedasMSA100or PeakFlowMeterortheMeter),readthefollowingpointscarefullyandadheretothem.After readingthismanual,keepitinasafeplacewhereitcanbereferredtoanytimeaquestionarises. ModelNumber:MSA100 ProductName:PeakFlowMeter Manufacturer:BeijingM&BElectronicInstrumentsCo.,Ltd. Address:Room6319,Building1,No.27,YongwangRoad,DaxingBioengineeringandMedicine IndustryBase,ZhongguancunSciencePark,DaxingDistrict,Beijing Issueddate:May2016,Version:V1.9 Intellectualproperty The intellectual property of MSA100 and its manual belong to Beijing M&B Electronic InstrumentsCo.,Ltd.(hereinbelowmentionedasM&B).Copying,reproductionortranslationof alloranypartofthecontentsofthismanualwithoutM&Bspermissionisstrictlyprohibited.All rightsreservedbyM&B. Statement M&Bhasthefinalrightstointerpretationforthismanual. M&Bisresponsiblefortheproductssafety,reliabilityandperformanceifbelowconditions aresatisfied:
Assembly,extensions,modificationsorrepairarecarriedoutbypersonsauthorizedby M&B. TheotherrelatedelectricalequipmentusedtogetherwiththeMeterconformstoCE standards. MSA100isusedinaccordancewiththeinstructionsmanual. MaintenanceService Freeservicerange:
FreeservicesareofferedinaccordancewithM&Bwarrantyregulations. Feebasedservicerange:
II MSA100PeakFlowMeterInstructionManualV1.9 BeyondM&Bwarrantyregulations. Duringthewarrantyperiod,warrantyshallnotextendtothefollowingconditions:
1) Itisdamagedfromimproperuse. 2) Batteryvoltageisbeyondthescopeofproductspecification. 3) Naturaldisasters. 4) Replacedaccessories,consumableswithoutM&Bauthorization. 5) ModificationorrepairbyanyoneexceptforBeijingM&Bauthorizedpersonorcompany. Contactus Servicetelephoneandproductsupport:
PleasecontactM&Bifyouhaveanyquestionsregardingproductsupport.
+861061253803(WorkingTime:Monday~Friday8:30~17:30);
Orcontacttheregionalservicepartnerordistributor. Orderconsumablesandrepairparts Pleasepurchaserepairparts(mouthpieceetc.)fromtheM&Bservicepartnerordistributorin yourcountry. Otherquestions Pleasecontactusasbeloworvisitourwebsitewww.mbelec.com. Headquarters Company:BeijingM&BElectronicInstrumentsCo.,Ltd. Address: Room 6319, Building 1, No.27, Yongwang Road, Daxing Bioengineering and Medicine IndustryBase,ZhongguancunSciencePark,DaxingDistrict,Beijing InformationforTheEuropeanUnionrepresentative:
EuropeanUnionRepresentativeName:ShanghaiInternationalHoldingCorp.GmbH(Europe). EuropeanUnionRepresentativeAddress:Eiffestrasse80,20537Hamburg,Germany. III MSA100PeakFlowMeterInstructionManualV1.9 CAUTION:Whenthepeakflowmeterisusedtowatchlungconditionssuchasasthma,theuser should be under the care of a physician or other licensed health care professional. A licensed health care professionals advice is required to understand the meaning and importance of the measuresyougetwithyourpeakflowmeterandtodecideonanappropriatetreatmentplan. Thetreatmentplangiventoyoubyyourphysicianorotherlicensedhealthcareprofessionalwill tellyouwhatactiontotakewhentherearechangesinyourpeakflownumber. No matter what your peak flow measures are, if you have signs and symptoms such as chest tightness,shortnessofbreath,coughingorwheezingyoushouldfollowyourlicensedhealthcare professionalsadviceforcontactinghimorher. Instructions for using the peak flow meter must be followed carefully in order to get correct measureofairflow. Ifyouareunabletoobtainareadingyoushouldcontactyourphysicianimmediately. Thepeakflowmetershouldnotbeusedbymorethanoneperson. Ifyouhaveanyquestionsaboutyourpeakflowmeteranditsuse,talktoyourlicensedhealthcare professional. IV MSA100PeakFlowMeterInstructionManualV1.9 Content 2 1 2.2 2.3 2.4 2.5 2.6 2.1.1 2.1.2 2.1.3 2.1.4 BRIEFINSTRUCTION.....................................................................................................................................1 FunctionDescription........................................................................................................................1 1.1 1.2 IntendedUse....................................................................................................................................1 1.3 IndicationsforUse...........................................................................................................................2 1.4 MeasuringPrinciple.........................................................................................................................2 1.5 StepbystepInstructions...............................................................................................................2 TechnicalSpecification.....................................................................................................................3 1.6 OtherSpecification..........................................................................................................................3 1.7 1.8 CompositionofPackage..................................................................................................................3 1.9 TransportationandStorageConditions..........................................................................................4 1.10 OperatingCondition........................................................................................................................4 1.11 DeviceComposition.........................................................................................................................4 SAFETYPRECAUTIONS.................................................................................................................................5 SafetyInformation...........................................................................................................................5 2.1 TermsandSymbols..............................................................................................................5 Environment.........................................................................................................................5 Preparation..........................................................................................................................5 OtherNotices.......................................................................................................................5 TransportationandStorage.............................................................................................................6 InterferenceInstruction...................................................................................................................6 Classification....................................................................................................................................6 SafeOperationandProcessingConditions.....................................................................................6 StandardsandRegulationCompliance...........................................................................................7 3 MAINTENANCE............................................................................................................................................8 BatteryAssemblage.........................................................................................................................8 AssembleMouthpieceandTurbineintoMainUnit.......................................................................8 Cleaning............................................................................................................................................8 4 OPERATION................................................................................................................................................10 4.1 LCDScreenDisplayIntroduction...................................................................................................10 4.2 FirstTimeUse................................................................................................................................11 4.3 TimeSetting...................................................................................................................................11 4.4 Poweron/Poweroff......................................................................................................................12 4.5 Measuring......................................................................................................................................12 ImportantInformationforMeasuringandMonitoringofPeakFlowValues..............................14 4.6 4.7 SimpleAssessment(TrafficLightScheme)....................................................................................16 RecordsPlayback...........................................................................................................................16 4.8 4.9 Deleterecords................................................................................................................................17 4.10 DataTransmission..........................................................................................................................17 5 TROUBLESHOOTING..................................................................................................................................17 6 GUIDANCEANDMANUFACTURESDECLARATIONS.................................................................................19 7 TECHNICALSPECIFICATION........................................................................................................................22 3.1 3.2 3.3 I MSA100PeakFlowMeterInstructionManualV1.9 1 BRIEFINSTRUCTION 1.1 FunctionDescription MSA100PeakFlowMeterisahandheldpulmonaryfunctionmeasuringmedicaldevicethat measuresyourmaximumpossibleexhalationwhichiscalledpeakexpiratoryflow(PEF)andforced expiratoryvolumein1second(FEV1).TheaccuracymeetsAmericanThoracicSociety(ATS) Standard2005Revision. Apeakflowmeterisusedtomeasureapersonspeakexpiratoryflow,whichisasimple measureofairflowthatcantellyouhowwellyouarebreathing.Ittellsyouhowwellairismoving throughtheairwaysinyourlungs.ForcedExpiratoryVolume(FEV1)isameasureofthevolumeof airexpelledin1second.Ifyouhaveabreathingconditionsuchasasthma,C.O.P.D.,orchronic bronchitis,yourphysician(orotherlicensedhealthcareprofessional)mayrecommendthatyou useapeakflowmetertowatchforchangesinyourairflow.Yourphysician(orlicensedhealthcare professional)willgiveyouatreatmentplanthatwilltellyouwhatactionstotakewhenyouhavea changeinairflow.Inaddition,youshouldrecordyourpeakflowmeasuresasrecommendedby yourphysician(orotherlicensedhealthcareprofessional).Reviewingpeakflowmeasurescan helpyouandyourphysician(orlicensedhealthcareprofessional)checkscloselyonyourasthma orC.O.P.D.toprovidethebesttreatmentforyou. MSA100issuitableforchildrenthroughadultswhoarecapableoffollowingtheinstructions foruse.BecausetheMeterhasanautomaticmemorythreehundredsreadings,youcantakethe Meter with you the next time you visit your doctor for a review of many readings. The doctor makesanappropriatetreatmentplanbasedonthem,andhelpspatientstorecuperatehealth. MSA100PeakFlowMetersupportsUSBconnection.Whenmeasurementrecordsaddupto maximumvolume,youcantransfertherecordstoPCviaUSB.Thenusingsoftwaretohelpsave andtrackforlongterm. Thepeakflowmetershouldnotbeusedbymorethanoneperson. 1.2 IntendedUse MSA100isintendedformonitoringPEF(PeakExpiredFlowRate)andFEV1(ForcedExpiratory Volume)forpatientuseathome.Thedeviceisdesignedforpediatrictoadultpatients.Whenthe MeterisusedtomonitorlungconditionssuchasasthmaorC.O.P.D.,theusershouldbeunderthe 1 MSA100PeakFlowMeterInstructionManualV1.9 careofalicensedhealthcareprofessional.Alicensedhealthcareprofessionalsadviceisrequired tounderstandthemeaningandimportanceofmeasurementsreportedbytheMeterandhowto decideonanappropriatetreatmentplan.Thistreatmentplanwilltellthepatientwhatactionto takewhentherearechangesintheirpeakflowmeasurements. 1.3 IndicationsforUse This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced ExpiratoryVolumeinonesecond)forpatienthomeuse.Thedeviceisdesignedforpediatricto adultpatients.Thedeviceisintendedformonitoringrespiratoryconditionssuchasasthma. 1.4 MeasuringPrinciple 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 displayedontheLCD. 1.5 StepbystepInstructions PLEASEREADALLOFTHEINFORMATIONINTHEPACKAGEINSERTBEFOREUSINGTHEPEAKFLOWMETER. IFYOUDONOTUNDERSTANDTHEINSTRUCTIONS,CONSULTM&B,CALL(+86)1061253803(WorkingTime:
fromMondaytoFriday,8:30~17:30),ORWRITETOmarket@mbelec.com. ASKYOURPHXSICIANOROTHERLICENSEDHEALTHCAREPROFESSIONALTOWATCHYOUUSETHEPEAKFlOW METER.THISWILLHELPASSURETHATYOUAREUSINGITCORRECTLY. NOMATTERWHATYOURPEAKFLOWMEASURESARE,IFYOUHAVESIGNSANDSYMPTOMSSUCHASCHEST TIGHTNESS, SHORTNESS OF BREATH, COUGHING OR WHEEZING YOU SHOULD FOLLOW YOUR LICENSED HEALTHCAREPROFESSIONAL'SADVICEFORCONTACTINGHIMORHER. IFYOUAREUNABLETOOBTAINAREADINGYOUSHOULDCONTACTYOURPHYSICIANIMMEDIATELY. a. Get the peak flow meter ready (take out of case, insert mouthpiece, position indicator;
directionswilldifferaccordingtodevice) b. Standup c. Takeadeepbreathin 2 MSA100PeakFlowMeterInstructionManualV1.9 d. Placethemeterinthemouthandcloselipsaroundthemouthpiece.Makesureyourlips formatightsealaroundthemouthpiece.Donotputyourtongueintothemouthpiece.Do notbendyourneck. e. Blowoutashardandfastasyoucan. f. Readthenumbernexttotheindicator.Thisisyourpeakflowmeasure.Writeitdown. g. After you move the indicator back to zero, repeat the steps two more times to get two morepeakflowmeasures. h. Choosethehighestnumberofyourthreepeakflowmeasures.Writethenumberinyour PeakPlowDiary."Directionsforthediaryarewrittenonthediary. i. Howtostoreyourpeakflowmeter(directionswilldifferaccordingtodevice). 1.6 TechnicalSpecification 1. Measuringmethod Flow Volume 2. Measuringrang Volume Flow 3. Accuracy Volume Turbinesensor FlowIntegration 0.01L~9.99L 50L/min~900L/min 3%or0.05L,whicheverisgreater Flow 4. Display 5. Memory 1.7 OtherSpecification 10%or20L/min,whicheverisgreater Segmentliquidcrystaldisplay 300measurementswithdataandtime TypeBappliedpart. Caution ModelMSA100 PowersourceAAA1.5V2alkalinebatteries 1.8 CompositionofPackage Name No. 1 Mainequipment Quantity Note 1 MSA100 Unit piece 3 MSA100PeakFlowMeterInstructionManualV1.9 2 Turbinesensor 3 Mouthpiece 4 Instructionmanual piece piece piece 1 1 1 5 1 USBcable piece 1.9 TransportationandStorageConditions 1. Environmenttemperatureof10degC~+55degC;
2. Relativehumidityof 93%;
3. Atmosphericpressureof500hPa~1060hPa. 1.10 OperatingCondition 1. Environmenttemperatureof+10DegC~+40DegC;
2. Relativehumidityof25%~85%;
3. Atmosphericpressureof860hPa~1060hPa. 1.11 DeviceComposition MSA100PeakFlowMeterisdividedintopartsbelowlikeFigure11. 1. Mainequipment. 2. AAA1.52alkalinebatteries. 3. Mouthpieceandturbinesensor. Figure11MakeupofMSA100PeakFlowMeter 4 MSA100PeakFlowMeterInstructionManualV1.9 2 SAFETYPRECAUTIONS 2.1 SafetyInformation 2.1.1 TermsandSymbols Asthemanufacturerofmedicaldevices,thecompanystrivestoensurethesecurity,reliability andperformanceoftheinstrument.Forcorrectuseofthisinstrument,readthefollowingpoints carefullyandadheretothem.Afterreadingthismanual,keepitinasafeplacewhereitcanbe referredtoanytimeaquestionarises. 2.1.1.1 TermsandDefinition This manual is using the term of "ATTENTION", etc. frombeginning to end, which aims to indicatethedangerandspecifiedseveritydegreeorlevel.Pleasebefamiliarwithitsdefinitionand importance. ATTENTION:Denotespotentialdangerorunsafetreatmentwhichmayresultinslightinjury ordamagetothedeviceorotherproperty.Thenoteprovidesapplicationhintsor otherusefulinformation.Readthenotecarefullytoensuresafeandcorrectuse. 2.1.1.2 ExplanationofSafetySymbols Symbols Explanation Denotesanoteorwarningcontent;
Denotesaprohibitedoperation.Theoperationmustneverbeperformed;
Performtheoperationaccurately.Theinstructionmustbestrictlyadheredto. 2.1.2 Environment ATTENTION:
Ambient temperature exceeding the range of technical specification will affecttheMetersaccuracy,whichwillcausethemachinedamagedormachine lifereduced. 2.1.3 Preparation ATTENTION:
Beforeusingthedevice,operatormustverifywhetherworkproceduresand conditionsareappropriatefortheuseofthisinstrument. 2.1.4 OtherNotices 5 MSA100PeakFlowMeterInstructionManualV1.9 ATTENTION:
Inordertoavoidelectricshockordetectorfailure,donotallowanyliquidto permeate into the device. If liquid has permeated into it, please contact your localservicepartnerordistributorofM&Btoinspectthemeter. ATTENTION: Donotusethedetectornearflammableanestheticgases,steamorliquid. ATTENTION:
For safe operation of the device, the user must follow this instruction manual. However, these instructions do not supersede established medical proceduresconcerningrespiratorysystemexamination. ATTENTION: Donotreplaceaccessories,consumableswithoutM&Bauthorization. 2.2 TransportationandStorage ATTENTION:
PuttheMeterintothespecifiedstoragecaseduringtransportation. 2.3 InterferenceInstruction ATTENTION:
TheMSA100hasfunctionsthatitdoesnotaffectnormaloperationofother devices,orisnotaffectedbyotherdevices. 2.4 Classification Typeofprotectionagainstelectricshock Internalpowerdevice Degreeofprotectionagainstelectricshock TypeBappliedpart objects of 12,5 mm and greater and IP22, Protected against solid foreign Degreeofprotectionagainstliquidpenetration Protection against vertically falling waterdropswhenENCLOSUREtiltedup to15 ATTENTION:
Theclassificationoftheelectricalshock,firedisaster,machineryandother specialrisksisdoneaccordingtoEN606011. 2.5 SafeOperationandProcessingConditions Thesterilizationordisinfectionmethod Notapplicable recommendbymanufacturer Electromagneticinterference Avoidtheusingofwirelesstelephonesorotherstrong interferenceequipmentneartheMeter 6 MSA100PeakFlowMeterInstructionManualV1.9 WorkMode Interval Electricsurgicalinterferencedamage Nodamage M&BElectronicInstrumentsCo.,Ltddoesnotacceptliabilityorresponsibilityforincorrect useoroperationoftheMSA100. ATTENTION:
Ifindoubt,consultyourPhysicianorHealthcareexpert ATTENTION: Nomodificationofthisequipmentisallowed. ATTENTION: Donotmodifythisequipmentwithoutauthorizationofthemanufacturer. ATTENTION:
If this equipment is modified, appropriate inspection and testing must be conductedtoensurecontinuedsafeuseoftheequipment. 2.6 StandardsandRegulationCompliance EN6060112006:MedicalElectricalEquipmentGeneralRequirementsforSafety;
IEC60601122004:MedicalElectricalEquipmentSafetyRequirementsEMC;
ATSStandardizationsofspirometry2005Revision. 7 MSA100PeakFlowMeterInstructionManualV1.9 3 MAINTENANCE 3.1 BatteryAssemblage Show as figuire31, slide the cover down, insert two AAA batteries in the shell following symbolinside,andclosethecover. Figure31MSA1000batteryassemble ATTENTION:
IfdonotuseMeterforlongtime,pleasetakeoutbatteriesfrombatterycase toavoidbatteryleakage. ATTENTION:
Pleaseselectbatterieswithregularfactoryinsteadoffakeandshoddy batteries. 3.2 AssembleMouthpieceandTurbineintoMainUnit. Insertmouthpiecetoturbinesensor,thentheassemblageofmouthpieceandturbinescrew clockwiseintomainunit.Seetheprocedureatfigure32. Figure32Assemblemouthpieceandturbine 3.3 Cleaning 8 MSA100PeakFlowMeterInstructionManualV1.9 ATTENTION:
Pleasecleanmouthpiecewhenfirsttimeuse,preventfromdustbecauseof transportorstorage. The Metershould be cleaned within 30 minutes after each use. Separate mouthpieceand 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 mouthpiecewithwater(distilledwaterisrecommended).Allowthedevicetoairdry. Figure33Disassembleturbineandmouthpiece ATTENTION: Dont use high pressure water or running water to rinse turbine, which maybeleadtodamageturbine,andmakeaccuracydeteriorative. Dontuseboilingwatertorinseturbine. Whendried,assemblemouthpieceandturbine,andinsertitintomainunit. UsecleananddampclothcleanmainbodyofMSA100,butneverputmainbodyintowater. Showasfigure34. Figure34cleaningtomainunit 9 MSA100PeakFlowMeterInstructionManualV1.9 4 OPERATION 4.1 LCDScreenDisplayIntroduction Figure41LCDdemonstration Figure41showsallsegmentofLCDdisplaying,andthecharactersandsymbolsmeaningis describedbelow.
:Fourrowsdigitdisplay,indicatingindividuallydate,time,measurementvalue,andrecord number. Day :Indicatenoworhistoricalmeasurementrecordday. Month:Indicatenoworhistoricalmeasurementrecordmonth. T :Indicatenoworhistoricalmeasurementrecordtime. Y :Indicatenoworhistoricalmeasurementrecordyear. AM :Indicatenoworhistoricalmeasurementrecordtimeisbefore12:00. PM :Indicatenoworhistoricalmeasurementrecordtimeisafter12:00. PEF :IndicatenoworhistoricalmeasurementPEFvalue. FEV1 :IndicatenoworhistoricalmeasurementFEV1value.
:Symbolofinsufficientbatteryvolume L/min :UnitofPEFvalue. L :UnitofFEV1value. MR :RecordsnumberorID.
:Indicatortotrafficcolouroutsidesurfaceofmainunit,thepositionofarrowmeansthe degreeofPEFnormalordeclined. 10 MSA100PeakFlowMeterInstructionManualV1.9
:IndicateUSBcablehasconnectedandtherecordscanberead. 4.2 FirstTimeUse Firstlyassemblemouthpieceandturbineaccordingsection3.2. Secondlyinsertbatteriesaccordingtosection3.1.PoweronMSA100,themainunitenters timesettingstate. 4.3 TimeSetting Afternewbatterieshavebeeninserted,theLCDdisplayisshownasfigure42.Whiletheyear 2012isblinking,itindicatestheyearwaitingforsetting.Systemdefaultsettingisyear:2012, month:1,day:1,time12:00amoclock.Assumetargetyearis2013,settingmethodsarebelow. Figure42Initialdisplayafterpoweron Pressleftkeyorrightkeytochangeyear.Ifpressleftkeyonce,theyeardisplayingdecrease1. Ifpressrightkeyonce,theyeardisplayingincrease1.Set2013,youshouldpressrightkeyonce. Thenpresspower/confirmkeyonceturntonextsetting,shownasfigure43.Pleasenote:ifyou holddownthekeymorethan2seconds,itspeedsup. ATTENTION:
Ifdateandtimeisnotset,youcantusetomeasure.Ifdateandtimeisnot setcorrectly,yourrecordsdatemaybewronglater,whichwillmakehistorical recordtimeincorrect. 11 MSA100PeakFlowMeterInstructionManualV1.9 Figure43yearsetting Nowtheyearcharactersarenotblinking,meaningtheyearhassetover.Followingthemonth 1beginsblinking,youshouldsetmonth.Thesettingwaylikemonth,day,hourandminute,is thesameasthatofyear.Whenalldateandtimeissetover,thedeviceentersintomeasurestatus. 4.4 Poweron/Poweroff Withthemeteroff,presspower/confirmkeyonce;themeterwillpoweron. Withthemeteron,presspower/confirmkeyuntilthebuzzerbeginbeep,thenreleasethe key, the meter will power off. Before the meter switches off, the highest vales of the current measurementsessionanditsrelatedmemorypositionMRXXXisdisplayed. Afterpoweron,thesystemcankeepactivestatuswithinoneminute,thenitwillpoweroff automatically.Ifpressanykeyormeasureoncemore,thesystemwillprolong1minutetopower off. 4.5 Measuring Whenthesystempoweron,thelastresultisshown,andthenthedeviceindicatesREADY 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. Showasfigure44.Alongbeepconfirmsthattheresultisrecorded.PEFisdisplayedforabout3 seconds followed by FEV1 and then the monitor is ready for a new measurement which is indicatedbytwoshortbeeps.Showasfigure45. It is recommended to perform three or moremeasurements sequentially. The device shall memorythebestvalueasthetestresult. After each measurement, at first the actual reading is shown in the display and then it switchesautomaticallytothehighestreadingofyourcurrentmeasurementsession. 12 MSA100PeakFlowMeterInstructionManualV1.9 StoretheMeterinacleananddustfreeplace. ATTENTION: Askyourphysician(orotherlicensedhealthcareprofessionals)towatchyou use this peak flow meter before you rely on any measurements. Read all informationinthisinstructionbookletbeforeusing. ContactM&Bat8008100520,+8601061253747+86010612537168020+86 010612537168001/80028AM5PMMondayFridaywithquestions;orcontact withM&Bservicepartnerordistributor. ATTENTION:
Ifyouhavesignsandsymptomssuchaschesttightness,shortnessofbreath, coughing or wheezing follow your physicians (or other licensed health care professionals)adviceforcontactingthemnomatterwhatreadingsyouobtain. Ifyoudonotgetareadingcontactsyourphysicianimmediately. ATTENTION: DonotmeasurePEFandFEV1understrongsunlight. Figure44Peakexpiremeasuringmethod Figure45PEFandFEV1measurementvaluedisplay Please note: MSA100 saves the highest PEF reading from switching the device on until 13 MSA100PeakFlowMeterInstructionManualV1.9 switchingthedeviceoff. 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 inhalingyourprescribeddrugs.Carryoutadditionalmeasurementwheneveryoufeelunwellor perceiveshortnessofbreath. Pleasenotethatasthmaattacksareindicatedinadvancebylowpeakflowvaluesbeforeyou feel it! Please contact your doctor in cases such as these. Also do so if you have signs and symptomssuchaschesttightness,shortnessofbreathcoughingorwheezing. Selfmeasurementmeanscontrol,notdiagnosisortreatment.Inanyevent,pleasebesureto discuss your measured values with your doctor. Your doctor will also explain which values are normalforyou. Youshouldneveralterthedosagesofanymedicationwithouttalkingtoyourdoctor. Pleasenotethatthedevicestoresupto300measuredvalueswithdateandtime.Whenthe memory is full, shown as figure45, erase all records yourself, or visit your doctor in time, let he/shetoanalyzeyourdata. Pleaseconfirmthatdateandtimesettingsarealwaysactual. DonotmeasurePEFandFEV1underoutdoorstrongsunlight. The performance of the Meter can be affected by extremes of temperature and humidity. Pleaserefertotechnicalspecificationsfordetails.
*Table41NormalPEFvaluesforMales(CaucasianAmerican) Height(cm) 180 170 160 150 140 120 130 190 200 171 208 249 292 339 388 441 496 554 185 222 262 306 352 402 454 510 568 246 283 324 367 414 463 516 571 629 347 384 425 468 515 564 616 672 730 354 392 432 475 522 571 624 679 738 357 395 435 479 525 575 627 682 741 357 394 435 478 525 574 626 682 740 352 390 430 474 520 570 622 677 736 344 382 422 465 512 561 614 669 727 332 369 410 453 500 549 601 657 715 Age
(Years) 8 10 15 20 25 30 35 40 45 50 14 MSA100PeakFlowMeterInstructionManualV1.9 55 60 65 70 75 80 85 90 316 353 394 437 483 533 585 641 699 296 333 373 417 463 513 565 621 679 272 309 349 393 439 489 541 597 655 244 281 322 365 411 461 513 569 627 212 249 290 333 380 429 482 537 595 176 214 254 298 344 393 446 501 560 137 174 215 258 304 354 406 462 520 93 131 171 215 261 310 363 418 477
*Table42NormalPEFvalueforFemales(CaucasianAmerican) Age
(Years) 8 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 Height(cm) 180 170 140 160 190 200 120 130 150 170 198 228 261 295 332 371 413 456 207 235 265 297 332 369 408 449 493 262 290 320 353 387 424 463 505 548 275 303 333 365 400 437 476 517 561 282 310 340 372 407 444 483 524 568 286 313 344 376 411 448 487 528 572 286 314 344 377 411 448 487 529 572 284 312 342 374 409 446 485 526 570 278 306 336 369 403 440 479 521 564 270 298 328 360 395 432 471 512 556 258 286 316 349 383 420 459 501 544 243 271 301 334 368 405 444 486 529 225 253 283 316 351 387 427 468 511 204 232 263 295 330 366 406 447 490 180 208 238 271 305 342 381 423 466 153 181 211 244 278 315 354 396 439 123 151 181 213 248 285 324 365 409 90 118 148 180 215 252 291 332 376
*SpirometricReferenceValuesfromaSampleoftheGeneralU.S.Population,JohnL.Hankinson,JohnR.Odencrantz,andKathleen B.Fedan,et.al.,DivisionofRespiratoryDiseaseStudies,NationalInstituteforOccupationalSafetyandHealth,CentersforDisease ControlandPrevention,Morgantown,WestVirginia,1999.TheThirdNationalHealthAndNutritionExaminationSurvey(NHANES III). Figure45Memoryisfull 15 MSA100PeakFlowMeterInstructionManualV1.9 4.7 SimpleAssessment(TrafficLightScheme) Usinggreen,yellowandredtrafficlighttoexpressthedegreeofyourillnessisastraightway. Greenindicatesillnessisundercontrol,dontrequirehighermedicationdosage.Yellowindicates you must caution, if your measured values frequently be located in this area, increase your medicationdosageasdiscussedwithyourphysician.Redindicatesitisdangerous.Actasdiscussed withyourphysicianorseekemergencymedicaltreatment. Simpleassessmentsettingsneedtoconsultwithyourdoctors(orotherlicensedhealthcare professionals).Thegeneralsettingmethodisbelow.
(1)MeasureyourpersonalbestvalueusingMSA100,whichisthehighestvalueyouachieve under optimum conditions (free of symptoms, feeling well). Or choose NHANES III or other effectivepredictiontocalculateanormalvalue,itistobeasabestvalue.
(2)PressandholdPowerKeyforalongtime,whileinstallthebattery.DonotloosenPower Key, until you can see predicted value of PEF blinked. It is traffic light scheme basic value or predictionvalue.
(3) Then use Right Keyor Left Keyto increaseor decrease value, enter your bestvalue or normalPEFvalueshownasTable4,
(4)PressPowerKeyonceagain,thendisplay
,settingsuccesses.
(5)Thegreenarealowerlimitusuallyreachesupto80%ofthepredictedvalue,theyellow arealowerlimitusuallyreachesupto50%ofthepredictedvalue,thepercentisnotallowedto edit,anditisdefaultintheMeter. 4.8 RecordsPlayback When the system enters into measuring status, press key left or right, you can watch historicalrecords.Ifyoukeeppressingthebuttonyoucanmovequicklythroughtherecords.At the same time record number will refresh with increasing or decreasing number. The records containmeasureddate,time,PEFvalue,FEV1valueandpositioninmemory.Presspower/confirm keyonceorwaitthecurrentrecorddisplayover,thesystemwillentersintomeasuringstate. 16 MSA100PeakFlowMeterInstructionManualV1.9 Figure46Recordsplayback 4.9 Deleterecords In measuring status press left and right key for five seconds long, and all records will be deleted.Thehintafterdeletedisshownasfigure47. Figure47Allrecordshasdeleted 4.10 DataTransmission MSA100 can transmit measured records to PC via USB. All records could be playback and statisticallyanalyzed.WhenMSA100isconnectedwithPC,MSA100displays
. ATTENTION:
Thisfunctionisoptional,youmayaskdistributorfordetail. 5 TROUBLESHOOTING Message Cause ThePEFresultishigherthan900L/min,or FEV1resultishigherthan9.99L Remedy thisisaverygoodresult 17 MSA100PeakFlowMeterInstructionManualV1.9 Means records address exceeds limit, or recorddateandtimeiserror,orsoftware isfailure Recordsdonotexist Restartsystem norecords Memoryisfull batteryinsufficient display NO screen Measuring error on Batteryislow,orbatterypoleisreversed. value It is better to delete records, ornewrecordisnotstored It is better to change new batteries Change new batteries, and notepoledirection Inspect whether the leaf of turbine is run freely. And the leaf consult whether the value is normal withyourdoctor is dirty. Or OtherquestionpleasecontactwithM&Bservicepartnerordistributor. 18 MSA100PeakFlowMeterInstructionManualV1.9 6 GUIDANCEANDMANUFACTURESDECLARATIONS ElectromagneticEmissions TheMSA100peakflowmeterisintendedforuseintheelectromagneticenvironmentspecifiedbelow. Thecustomerortheuserofthedeviceshouldensurethatitisusedinsuchanenvironment. Emissionstest RFemissions CISPR11 Compliance Electromagneticenvironmentguidance TheMSA100peakflowmeterdetectorusesRFenergyonly foritsinternalfunction.Therefore,itsRFemissionsarevery lowandarenotlikelytocauseanyinterferenceinnearby electronicequipment. TheMSA100peakflowmeterdetectorissuitableforuseinall establishments,otherthandomesticestablishmentsand powersupplyisinternal. Group1 ClassB RFemissions CISPR11 ElectromagneticImmunity TheMSA100peakflowmeterdetectorisintendedforuseintheelectromagneticenvironmentspecified below.Thecustomerortheuserofthedeviceshouldensurethatitisusedinsuchanenvironment. IEC60601testlevel 2kVcontact 4kVcontact 6kVcontact 8kVcontact 2kVair 4kVair 8kVair 15kVair 10A/m Compliancelevel 2kVcontact 4kVcontact 6kVcontact 8kVcontact 2kVair 4kVair 8kVair 15kVair 10A/m Immunitytest Electrostatic discharge(ESD) IEC6100042 Powerfrequency
(50/60Hz) magneticfield IEC6100048 Radiated RF IEC 6100043 3V/m 80MHzto2.5GHz 3V/m 19 Electromagnetic environmentguidance Floorsshouldbewood, concreteorceramictile.If floorsarecoveredwith syntheticmaterial,the relativehumidityshouldbe atleast30%. Powerfrequencymagnetic fieldsshouldbeatlevels characteristicofatypical locationinatypical commercialorhospital environment. d 2.3 P 800MHz to2,5GHz wherePisthemaximum outputpowerratingofthe transmitterinwatts(W)and distherecommended separationdistancein meters(m)b. MSA100PeakFlowMeterInstructionManualV1.9 FieldstrengthsfromfixedRF transmitters,asdetermined byanelectromagneticsite survey,ashouldbelessthan thecompliancelevelineach frequencyrange.b Interferencemayoccurin thevicinityofequipment markedwiththefollowing symbol:
a Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephones andlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbe predictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRF transmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthin thelocationinwhichMSA100peakflowmeterdetectorisusedexceedstheapplicableRF compliancelevelabove,MSA100peakflowmeterdetectorshouldbeobservedtoverifynormal operation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchas reorientingorrelocatingMSA100peakflowmeterdetector. b Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m. EMCDeclaration Withmanyelectronicdevicessuchasmicrowave,TV,wirelessrouter,PCs,andmobiles,medical devicesinusemaybesusceptibletoelectromagneticinterferencefromthesedevices.Thismay result in incorrect operation of the medical device and create a potentially unsafe situation. Medicaldevicesshouldbekeptdistance1mfromthoseelectronicdevices. InordertoregulatetherequirementsforEMCwiththeaimtopreventunsafeproductsituations, theEN6060112standardhasbeenimplemented. Thisstandarddefinesthelevelsofimmunitytoelectromagneticinterferencesaswellasmaximum levelsofelectromagneticemissionsformedicaldevices. MedicaldevicesmanufacturedbyM&BconformtothisEN6060112standardforbothimmunity andemissions. Themedicaldevicesshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacent orstackeduseisunavoidable,themedicaldeviceshouldbeseentooperatenormallyasitshould inthissituation. FCCDeclaration Note:ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable 20 MSA100PeakFlowMeterInstructionManualV1.9 protection against harmful interference in a residential installation. This equipment generates, uses,andcanradiateradiofrequencyenergy,andifnotinstalledandusedinaccordancewiththe instructions, may cause harmful interference to radio communications. However, there is no guaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescause harmful interference to radio or television reception, which can be determined by turning the equipmentoffandon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreof thefollowingmeasures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connect the equipment into an outlet on a circuit different from that to which the receiverisconnected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. Changesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecould voidtheusersauthoritytooperatetheequipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1)Thisdevicemaynotcauseharmfulinterference,and
(2)Thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycause undesiredoperation. 21 MSA100PeakFlowMeterInstructionManualV1.9 7 TECHNICALSPECIFICATION 0.01L Airflowresolution 0.01L~9.99L 0.050Lor3%
Airflowrange Airflowaccuracy 50L/min~900L/min 10%or20L/min Turbine FEV1/PEF 300 PEFandFEV1resultsdisplayedatBTPSconditions MSA100PeakFlowMeterisahandholdpulmonaryfunctionmeasuringmedicaldevicethat measuresyourmaximumpossibleexhalationwhichiscalledpeakexpiratoryflow(PEF)andforced expiratoryvolumein1second(FEV1).TheparametersaredisplayedontheLCDscreen.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 recordstoPCviaUSB,thenasoftwarehelptosaveandtrackforlongtime. General Sensortype Measurementparameters Memorysize BTPS Accuracy MeetATS2005Revisionaccuracyrequirement Volumerange Volumeaccuracy Resolution Volumeresolution Resistancetoflow Backpressure@660L/min Backpressure@900L/min Repeatability PEF FEV1 Displayscreen Size Type Control Standard Environmentspecification Powersource Design Batteryworktime Connection Operation Temperature Humidity AAA1.52batteries Interval,ordinarydevice Maximumoneyear Wherefitted,USBforPCconnection.RequireaUSBAtoUSBminiB 10oC40oC 25%~85%
5%or10L/min 3%or0.05L power/confirmkey,left/rightkey
<0.11KPa/sec
<0.15KPa/sec 1.8inches LCD 1L/min 22 860hPa1060hPa 10oC55oC 15%~93%
500hPa1060hPa MSA100PeakFlowMeterInstructionManualV1.9 Atmosphere Storage Temperature Humidity Atmosphere Zoning Green/Yellowthreshold Green/Yellowthreshold Physicalspecification Height Wide Thickness Weight 12.6centimeter 5.4centimeter 2.8centimeter 120gcontain batteries andmouthpiece 80%ofreference 50%ofreference Maintenancewarranty Oneyear Standard Provideotheroptions. Option ThedetailpleasecontactwithM&Banddistributors. 23
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2016-07-01 | JBP - Part 15 Class B Computing Device Peripheral | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 | Effective |
2016-07-01
|
||||
| 1 | Applicant's complete, legal business name |
Beijing M&B Electronic Instruments Co., LTD
|
||||
| 1 | FCC Registration Number (FRN) |
0025688680
|
||||
| 1 | Physical Address |
No 27,Yongwang Road,Beijing Bioengineering
|
||||
| 1 |
Huangcun Town Daxing district, Beijing, N/A
|
|||||
| 1 |
China
|
|||||
| app s | TCB Information | |||||
| 1 | TCB Application Email Address |
t******@timcoengr.com
|
||||
| 1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
| app s | FCC ID | |||||
| 1 | Grantee Code |
2AIV3
|
||||
| 1 | Equipment Product Code |
MB-MSA100
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 | Name |
y******** G****
|
||||
| 1 | Telephone Number |
010-6********
|
||||
| 1 | Fax Number |
010-6********
|
||||
| 1 |
3******@qq.com
|
|||||
| app s | Technical Contact | |||||
| n/a | ||||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 | Equipment Class | JBP - Part 15 Class B Computing Device Peripheral | ||||
| 1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Part 15 Class B Computing Device Peripheral | ||||
| 1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 | Modular Equipment Type | Does not apply | ||||
| 1 | Purpose / Application is for | Original Equipment | ||||
| 1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
| 1 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 | Firm Name |
Centre Testing International Group Co., Ltd
|
||||
| 1 | Name |
S******** L********
|
||||
| 1 | Telephone Number |
86755********
|
||||
| 1 | Fax Number |
86755********
|
||||
| 1 |
s******@cti-cert.com
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15B | |||||||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC