Withings WPM02 Blood Pressure Monitor User Manual 20130826 BP801 manuel SGSx

Withings Blood Pressure Monitor 20130826 BP801 manuel SGSx

Users Manual

WithingsBloodPressureMonitorVersion2.0AUG.2013
Withings Blood Pressure Monitor User’s Guide 2WithingsisthetrademarkofthisproductandallothertrademarksorWebsitementionedinthisdocumentarethepropertiesoftheirrespectiveowners.DisclaimerInformationinthisguidemaychangewithoutnotice.Themanufacturerassumesnoresponsibilitiesforerrorsthatmayappearinthisguide.ReferencetoStandardsThisdevicecomplieswiththefollowingnormativedocuments:COUNCILDIRECTIVE93/42/EECof14June1993concerningmedicaldevicesasamendedbyDirective2007/47/EC*ENISO13485:2003/AC:2009:Medicaldevices‐Qualitymanagementsystems–Requirementsforregulatorypurposes(ISO13485:2003)Referencetostandardscontd.*ENISO14971:2012:Medicaldevices‐Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007‐10‐01)*IEC60601‐1:2005+CORR.1(2006)+CORR.2(2007);EN60601‐1:2006+AC(2010):Medicalelectricalequipment‐Part1:GeneralrequirementsforbasicsafetyandessentialPerformance*EN1060‐3:1997+A1:2005+A2:2009:Non‐invasivesphygmomanometers,Part3:Supplementaryrequirementsforelectromechanicalbloodpressuremeasuringsystems*EN1060‐4:2004Non‐invasivesphygmomanometers.Testprocedurestodeterminetheoverallsystemaccuracyofautomatednon‐invasivesphygmomanometers.*IEC/EN60601‐1‐11:Generalrequirementsforbasicsafetyandessentialperformance–CollateralStandard:Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment*IEC80601‐2‐30:2009(FirstEdition)foruseinconjunctionwithIEC60601‐1:2005EN80601‐2‐30:2010/ANSI/AAMI80601‐2‐30:2009:Particularrequirementsforthebasicsafetyandessentialperformanceofautomatednon‐invasivesphygmomanometers*EN300328V1.8.1ElectromagneticcompatibilityandRadiospectrumMatters(ERM);Widebandtransmissionsystems;Datatransmissionequipmentoperatinginthe2,4GHzISMbandandusingwidebandmodulationtechniques;HarmonizedENcoveringtheessentialrequirementsofarticle3.2oftheR&TTEDirective*EN301489‐1‐3V1.9.2(2011)ElectromagneticcompatibilityandRadiospectrumMatters(ERM);ElectroMagneticCompatibility(EMC)standardforradioequipmentandservices;Part1:Commontechnicalrequirements*EN301489‐1‐17V2.2.1(2012)ElectromagneticcompatibilityandRadiospectrumMatters(ERM);ElectroMagneticCompatibility(EMC)standardforradioequipmentandservices;Part1:Commontechnicalrequirements*EN60601‐1‐2:2007CISPR:2011:Medicalelectricalequipment:Part1‐2:Generalrequirementsforbasicsafetyandessentialperformance‐collateralstandardelectromagneticcompatibility*EN55011:2009/A1:2010:Industrial,scientificandmedicalequipment‐Radio‐frequencydisturbancecharacteristics‐Limitsandmethodsofmeasurement*FCCpartB15B:2013ElectromagneticCompatibilityFCCRulePart:15.247Cat:DSS(Bluetooth)FCCRulePart:15.247Cat:DTS(BT4.0)*ENISO10993‐1:2009Biologicalevaluationofmedicaldevices‐Part1:Evaluationandtestingwithinariskmanagementprocess(ISO10993‐1:2009)*ANSI/AAMISP10:2002/A12003(R)2008:Manual,electronicorautomatedsphygmomanometers*ANSI/AAMI/ISO81060‐2:2009Non‐invasivesphygmomanometersPart2:ClinicalvalidationofautomatedmeasurementtypeRequirements 2013USImporter:WithingsInc.16192CoastalHighwayLewesDE19KahlHandelsvertretungAdd.:Isarstr.3340699Erkrath,GermanyTel:+49210447754WithingsSAS20bisrueRougetdeLisle92130Issy‐les‐MoulineauxTypeBFAppliedPart(cuff)   WEEEIP22IngressofwaterorparticulatematterFCCID:XNAWPM02EUREPRESENTATIVE
Withings Blood Pressure Monitor User’s Guide 3InordertouseyourWithingsBloodPressureMonitor,youneedaniPhone,iPad,iPodtouch(iOS5andhigher)orAndroid(v2.3.3andhigher)  Packagecontent WithingsBloodPressureMonitor FourAAAalkaline(LR3)cells(alreadyinserted) Micro‐USBtoUSBadapter UsermanualImportantSafetyInformationConsultyourdoctorduringpregnancy,arrhythmiaandarteriosclerosis.Pleasereadthissectioncarefullybeforeusingthebloodpressuremonitor.Micro‐USBtoUSBadapter
Withings Blood Pressure Monitor User’s Guide 4IntendeduseThedeviceisadigitalmonitorintendedforuseinmeasuringbloodpressureandpulserateinadultpatientpopulationwitharmcircumferencerangingfrom9inchesto17inches(22cm‐42cm).Thisdeviceisnotintendedtobeadiagnosticdevice.Contactyourphysicianifhypertensivevaluesareindicated.Generalsafetyandprecautions Donotforciblybendthearmcuff Donotinflatethearmcuffwhenitisnotwrappedaroundyourarm Donotapplystrongshocksandvibrationstothebloodpressuremonitorordropit Donottakemeasurementafterbathing,drinkingalcohol,smoking,exercisingoreating. DonotimmersethearmcuffinwaterCautionGeneralusageAlwaysconsultyourdoctor.Self‐diagnosisofmeasurementresultsandselftreatmentaredangerousPeoplewithseverebloodflowproblems,orblooddisorders,shouldconsultadoctorbeforeusingthebloodpressuremonitor.Cuffinflationcancauseinternalbleeding.Operationalfactorssuchascommonarrhythmias,ventricularprematurebeats,atrialfibrillation,arterialsclerosis,poorperfusion,diabetes,age,pregnancy,pre‐eclampsiaorrenaldiseasecanaffecttheperformanceoftheautomatedsphygmomanometerand/oritsbloodpressurereading.Thisdeviceisaprecisionmeasuringequipmentliabletobeunderstoodbylayuserbutitstillshouldbehandledwithcare.Alongexposureofthedevicetolint,dustorsunlightmightreduceitslifetimeordamageit.Damagedcufforsensormightleadtoincorrectmeasurements.• Donotleavethebloodpressuremonitorunattendedwithinfantsorpersonswhocannotexpresstheirconsent.• Donotusethebloodpressuremonitorforanypurposeotherthanmeasuringbloodpressure.• Donotdisassemblethebloodpressuremonitor.• Donotoperatethebloodpressuremonitorinamovingvehicle(car,airplane)• Donotuseacellularphonenearthedeivce.Itmayresultinanoperationalfailure.• Impropercontinuouspressureofcuffortoofrequentmeasurementsmayinterferebloodflowandresultharmfulinjurytotheusers.• Donotapplythecuffovertheusers’armbearingawoundormedicaltreatmentandsoon,asthiscancausefurtherinflucenceonthetherapy.AAAalkalinecellsusage• IfAAAalkalinecellsfluidshouldgetinyoureyes,immediatelyrinsewithplentyofcleanwaterandcousultadoctorimmediately.• UseonlyfourAAAalkalinecellswiththisbloodpressuremonitor.DonotuseanyothertypesofAAAalkalinecells.• DonotinsertAAAalkalinecellswiththeirpolaritiesincorrectlyaligned.•ReplaceoldAAAalkalinecellswithnewonesimmediately.ReplaceallfourAAAalkalinecellsatthesametime.• DonotusenewandusedAAAalkalinecellstogether
Withings Blood Pressure Monitor User’s Guide 5TableofcontentsAboutBloodPressure.....................................................................................................................6Installation..........................................................................................................................................7Begintomeasure,takeandstoreareading............................................................................9AfterUse...........................................................................................................................................11ErrorMessages...............................................................................................................................12Troubleshooting............................................................................................................................13FCCStatement.................................................................................................................................14
Withings Blood Pressure Monitor User’s Guide 6AboutBloodPressureWhatisbloodpressure?Bloodpressure(BP)isthepressureexertedbycirculatingblooduponthewallsofbloodvessels,andisoneoftheprincipalvitalsigns.Duringeachheartbeat,BPvariesbetweenamaximum(systolic)andaminimum(diastolic)pressure.ThemeanBP,duetopumpingbytheheartandresistancetoflowinbloodvessels,decreasesasthecirculatingbloodmovesawayfromtheheartthrougharteries.Formoreinformationsaboutbloodpressure,pleaseconsultourwebsite:www.withings.com/bloodpressureHowtomeasureyourbloodpressurecorrectlyBeforetakingareading,youshouldsitstillforaround10minutes,andyoushouldwait1minutebetweeneachreading.Whiletakingameasurement,remainsittedandstaycalmandrelaxed.Youshouldalsotrynottotalk.Thisshouldimprovetheaccuracyofreadings.Itisrecommendedtoalwaysmeasureyourbloodpressureonthesamearm.CorrectpostureRestyourarmonatableandrelaxyourarm.CorrectcuffplacementPutthecuffaroundyourarmwiththetubepositionedontheinnersideofyourarm,around2cmabovetheelbow.Wrapthearmcuffsnugly.Themetalsheetmustbealignedwiththearterialveinwhenwrappingthecuffonthearm.CorrectlevelMakesurethecuffisatthesamelevelthanyourheart.Ifyoucannotplaceyourarmatthesamelevelthanyourheart,useacushion.Yourarmshouldlightlybendwhiletakingthemeasurement.
Withings Blood Pressure Monitor User’s Guide 7InstallationAlkalinecellsarealreadyinstertedinyourWithingsBloodPressureMonitorwhenyoubuyit.Replacingthe«AAA»alkalinecellsIfthelowbatterysymbolappearsintheWithingsapplication,replaceallfourAAAalkalinecellsatthesametime.1. RemovetheAAAalkalinecellscoveratthelowerendofthealuminumtube.2. InstallorreplacefourAAAalkalinecellssothatthe+(positive)and–(negative)polaritiesmatchthepolaritiesindicatedontheAAAalkalinecellscompartment.3. PuttheAAAalkalinecellscoverbackinplace.Ifthedevicewillnotbeusedforalongperiodoftime,itisadvisedtoremovethealkalinecells.FirstuseUseyourbloodpressuremonitorwirelesslyoniOS1. Pressthebuttonontopofthebloodpressuremonitortoturniton2. OnyouriOSdevice,goto«Settings»,enterthe«Bluetooth»sectionandturnBluetoothon3. Inthedeviceslist,chooseWithingsBPM4. Thedevicestatuswillchangeto«connected»andapop‐upwillbringyoutotheWithingsapplicationontheAppStore5. DownloadtheWithingsHealthMateapplicationfortheAppStoreandopenitUseyourbloodpressuremonitorwirelesslyonAndroid1. Pressthebuttonontopofthebloodpressuremonitortoturniton2. OnyourAndroiddevice,goto«Settings»,enterthe«Bluetooth»sectionandturnBluetoothon3. Inthedeviceslist,chooseWithingsBPM4. Thedevicestatuswillchangeto«connected»5. DownloadtheWithingsHealthMateapplicationforthePlayStoreandopenitUseyourbloodpressuremonitorwithyoursmartphonecableoniOS1. PlugthesmartphoneUSBadpaterprovidedwithyourbloodpressuremonitortoit2. PlugyoursmartphonecabletotheadapterandyouriOSdevice3. Pressthebuttonontopofthebloodpressuremonitortoturniton4. Apop‐upwillaskyoutodownloadtheWithingsHealthMateapplicationontheAppStore5. DownloadtheWithingsHealthMateapplicationfortheAppStoreandopenitUseyourbloodpressuremonitorwithyoursmartphonecableonAndroid1. PlugthesmartphoneUSBadpaterprovidedwithyourbloodpressuremonitortoit2. PlugyoursmartphonecabletotheadapterandyourAndroiddevice3. Pressthebuttonontopofthebloodpressuremonitortoturniton4. DownloadtheWithingsHealthMateapplicationfortheAppStoreandopenit
Withings Blood Pressure Monitor User’s Guide 8HowtoMeasureyourbloodpressureWirelesslyoniOS1. UnlockyouriOSdevice2. Pressthebuttonontopofthebloodpressuremonitortoturniton3. Afterafewseconds,theWithingsHealthMateapplicationwillopen4. Navigatethroughthequickstartinstructionsbytouching«next»untilyoureachthemeasurementscreen(fig.1)WirelesslyonAndroid1. UnlockyourAndroiddevice2. Pressthebuttonontopofthebloodpressuremonitortoturniton3. Afterafewseconds,theWithingsHealthMateapplicationwillopen4. Navigatethroughthequickstartinstructionsbytouching«next»untilyoureachthemeasurementscreen(fig.1)UsingyourcableoniOS1. UnlockyouriOSdevice2. Pressthebuttonontopofthebloodpressuremonitortoturniton3. Afterafewseconds,theWithingsHealthMateapplicationwillopen4. Navigatethroughthequickstartinstructionsbytouching«next»untilyoureachthemeasurementscreen(fig.1)UsingyourcableonAndroid1. UnlockyourAndroiddevice2. Pressthebuttonontopofthebloodpressuremonitortoturniton3. Afterafewseconds,theWithingsHealthMateapplicationwillopen4. Navigatethroughthequickstartinstructionsbytouching«next»untilyoureachthemeasurementscreen(fig.1)
Withings Blood Pressure Monitor User’s Guide 9Begintomeasure,takeandstoreareading1. Onthemeasurementscreen(fig.1),touchthe«start»buttontolaunchthemeasurement.Thebloodpressuremonitorisdesignedtotakemeasurementsandstorethemeasurementvaluesinthememoryofthedevice(iPhone,iPadoriPodTouch).Usingthesinglemode• Onthemeasurementscreen(fig.1)pressthe«Start»button.Thecuffstartstoinflateautomatically.Asthecuffinflates,thebloodpressuremonitorautomaticallydeterminesyouridealinflationlevel.Thisbloodpressuremonitordetectsthepulseduringinflation.Donotmoveyourarmandremainstilluntiltheentiremeasurementprocessiscompleted.Note:Tostoptheinflationormeasurement,touch«Stop»buttonorpushthedeviceontopofthetube.Thebloodpressuremonitorwillstopinflatingandstartdeflating.• Inflationstopsandthemeasurementisstopped.Asthecuffdeflates,theheartbeatsymbolflashesateveryheartbeat.• Whenthemeasurementiscomplete,thearmcuffcompletelydeflates.Yourbloodpressureandpulseratearedisplayed.• Press«OK»toseeyourresultsinadvancedmode.Rotateyourdevicetodisplayyourgraphs.Note:Self‐diagnosisofmeasuredresultsandtreatmentaredangerous.Pleasefollowtheinstructionsofyourdoctor.Fig.1
Withings Blood Pressure Monitor User’s Guide 10UsingtheautomodeTheautomodewilltakethreemeasurementsseparatedbyanintervaloftimeinordertocalculateapreciseaverageofyourbloodpressure.• Onthemeasurementscreen(fig.2),touchthepreferencesicon.Makecertaintheautomodeisenabled.Selecttheinterval,betweeneachmeasurement.• Pressthe«Start»button.Thecuffstartstoinflateautomatically.Asthecuffinflates(fig.6),thebloodpressuremonitorautomaticallydeterminesyouridealinflationlevel.Thisbloodpressuremonitordetectsthepulseduringinflation.Donotmoveyourarmandremainstilluntiltheentiremeasurementprocessiscompleted.Note:Tostoptheinflationormeasurement,pressandreleasethe«Stop»button.Thebloodpressuremonitorwillstopinflatingandstartdeflating.• Inflationstopsandthemeasurementisstarted.Asthecuffdeflates,theheartbeatsymbolflashesateveryheartbeat.• Whenthemeasurementiscomplete,thearmcuffcompletelydeflates.• Aftertheselectedinterval,asecondandathirdmeasurementwillstart.• Youraveragebloodpressureisdisplayed.• Press«OK»attheendofameasurementtoseeyourresultsinadvancedmode.Rotateyourdevicetodisplayyourgraphs.Notes• Thethreeindividualmeasurementresultsarenotdisplayedwhileautomodeistakingthemeasurements.• Self‐diagnosisofmeasuredresultsandtreatmentaredangerous.Pleasefollowthein‐structionsofyourdoctor.• Youwillhavetoactivatetheautomodeeachtimeyouwanttouseit.Fig.2
Withings Blood Pressure Monitor User’s Guide 11AfterUseCleaning Donotuseanalcoholic‐baseorsolventagenttocleanthedevice. Cleanthedevicewithasoft,drycloth. Thedirtonthecuffcanbecleanedbyamoistenclothandsoap. Donotflushthedeviceandcuffwithmuchwater Donotdismantlethedeviceordisconnectthecuffortrytorepairbyyourself.Ifanyproblemhappens,refertothedistributor. Donotoperatethedeviceundersevereenvironmentofextremetemperatureorhumidity,ordirectsunshine. Donotshaketheunitviolently. Donotsubmergethedeviceoranyofthecomponentsinwater. Donotletthedeviceunderstrongshocks,suchasdroppingtheunitonthefloorStorage Ifyouarenotusingthedeviceforanextendedperiod,removethealkalinecellsfromthealuminiumtubeforstorage. Storethedeviceandthecomponentsinaclean,safelocationMaintenanceIfyoucan’tfixtheproblemsusingthetroubleshootinginstructions,requestservicefromyourdealer.Manufacturerwillmakeavailableonrequestedcircuitdiagrams,componentpartlists,descriptions,calibrationinstructions,orotherinformationthatwillassistmanufacturer’sstafforauthorizedrepresentativeforrepair.Itisgenerallyrecommendedtohavethedeviceinspectedevery2years,toensureproperfunctioningandaccuracy.
Withings Blood Pressure Monitor User’s Guide 12ErrorMessagesErrormessageCausesCountermeasureMeasurementcouldnotbeperformed.Pleasetryagain.Iftheproblemoccursagain,pleasecontactcustomerservice.Hardwareauto‐checkerror.1‐Measurementcouldnotbeperformed.Pleasetryagain.Iftheproblemoccursagain,pleasecontactcustomerservice.Connectionerror.Quittheapplicationandreconnectyourbloodpressuremonitor.CommunicationerrorbetweentheBloodPressureMonitorandthecollateraldevice.1‐Pushthebloodpressuremonitorbuttonfor3secondstoturnitoff.Quittheapplicationandpushthebloodpressuremonitorbuttontoturniton.2‐Iftheproblemoccursagain,pleasecontactcustomerservice.Pleasewaituntilthecuffistotallydeflatedbeforestartinganewmeasurement.Staystillduringmeasurement.‐Cuffisnotdeflatedbeforemeasurement.‐Noiseinterference.‐Excessiveusermovements.1‐Pleasewaituntilthecuffistotallydeflatedbeforestartinganewmeasurement.Staystillduringmeasurement.2‐Iftheproblemoccursagain,pleasecontactcustomerservice.CheckthattheBloodPressureMonitoriscorrectlypositionedonyourarmandthatmeasurementisperformedingoodconditions.‐Usermovement,ornotrelaxed,ortalking…‐Cuffisnotcorrectlyfastened‐Cuffbroken‐Pumporvalvefailure‐Pressureoverflow‐Noiseinterference‐Usermovement,ornotrelaxed,ortalking…‐Userspecialcharacteristics‐Batterylevelistoolow1‐CheckthattheBloodPressureMonitoriscorrectlypositionedonyourarmandthatmeasurementisperformedingoodconditions.2‐Lowbatterylevel.UnplugtheBloodPressureMonitor.Replacethealkalinecells.3‐Ifuserhasspecialcharacteristics,pleasecontactyourphysician.4‐Iftheproblemoccursagain,pleasecontactcustomerservice.Lowbatterylevel.UnplugtheBloodPressureMonitor.Replacethealkalinecells.Batterylevelistoolow.1‐Lowbatterylevel.UnplugtheBloodPressureMonitor.Replacethealkalinecells.2‐Iftheproblemoccursagain,pleasecontactcustomerservice.
Withings Blood Pressure Monitor User’s Guide 13TroubleshootingProblemRemedyThoughthebatteriesareinstalled,thereisnothinghappeningwhenconnectedtoiOSorAndroiddevice1. CheckthatyouriOSorAndroiddeviceisunlocked2. CheckandcorrecttheAAAalkalinecellspolarities3. RemovetheAAAalkalinecellsandwaitforoneminute.TheninstalltheAAAalkalinecellsback.4. ReplacetheAAAalkalinecellsTheinflationactioncannotbedoneortheairpressurecannotrise1. Checkthecuffpositionandfastenthecuffcorrectlyadre‐measurethepressureagain2. CheckthebloodpressuremonitorconnectiontotheiOSdeviceThelowbatteryiconisshownintheapplicationReplacetheoldalkalinecellsbyfournewAAAalkalinecells.Thebloodpressurecannotbetakenandtheapplicationshowsanerrormessageorwrongresult1. Re‐fastenthecuff2. Relaxyourselfandsitdown3. Keepthecuffandheartatthesamelevelduringthemeasurementperiod4. Keepsilentandstillduringmeasurement5. Ifthepatienthasseverheartbeatproblem,thenthebloodpressuremaynotbereadcorrectlyUndernormalmeasuringcircumstance,thereadingathomeisdifferentfromthatoftheclinicsoreachmeasurementhasvariousreading1. Thevariationisduetothedifferentenvironments2. Thebloodpressureischangingaccordingtothephysiologicalorpsychologicalstatusofthehumanbody3. Showyourrecordedvaluestoyourphysician
Withings Blood Pressure Monitor User’s Guide 14FCCStatementFederalCommunicationsCommission(FCC)Statement15.21Youarecautionedthatchangesormodificationsnotexpresslyapprovedbythepartresponsibleforcompliancecouldvoidtheuser’sauthoritytooperatetheequipment.15.105(b)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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.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ofthedevice.FCCRFRadiationExposureStatement:ThisequipmentcomplieswithFCCradiationexposurelimitssetforthforanuncontrolledenvironment.EndusersmustfollowthespecificoperatinginstructionsforsatisfyingRFexposurecompliance.Thistransmittermustnotbeco‐locatedoroperatinginconjunctionwithanyotherantennaortransmitter.ThisdevicecomplieswithIndustryCanadalicense‐exemptRSSstandard(s).Operationissubjecttothefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevicemustacceptanyinterference,includinginterferencethatmaycauseundesiredoperationofthedevice.
Withings Blood Pressure Monitor User’s Guide 15RFStatement‐MedicalElectricalEquipmentneedsspecialprecautionsregardingEMCandneedstobeinstalledandputintoserviceaccordingtotheEMCinformationprovidedinthefollowing.‐Interferencemayoccurinthevicinityofequipmentmarkedwith ‐PortableandmobileRFcommunicationequipment(e.g.cellphones)canaffectMedicalElectricalEquipment.‐Theuseofaccessoriesandcablesotherthanthosespecifiedmayresultinincreasedemissionsordecreasedimmunity.‐Thedevice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.‐Thedeviceissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclowvoltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.‐PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartofthedevice,includingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.‐ThedeviceisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.Anyotheraccessories,transducersandcablesmayresultinincreasedemissionsordecreasedimmunityandEMCperformance.‐Thedeviceshouldnotbeusedadjacenttoorstackedwithotherequipmentandthatifadjacentorstackeduseisnecessary,whichshouldbeobservedtoverifynormaloperationintheconfigurationinwhichitwillbeused.MedicalElectricalEquipmentneedsspecialprecautionsregardingEMCandneedstobeinstalledandputintoserviceaccordingtotheEMCinformationprovidedinthefollowing.PortableandmobileRFcommunicationequipment(e.g.cellphones)canaffectMedicalElectricalEquipment.Theuseofaccessoriesandcablesotherthanthosespecifiedmayresultinincreasedemissionsordecreasedimmunityoftheunit.Guidanceandmanufacturer’sdeclaration‐electromagneticemissionsTheWirelessBloodPressureMonitorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheWirelessBloodPressureMonitorshouldassurethatitisusedinsuchanenvironment.EmissionstestComplianceElectromagneticenvironment‐guidanceCEemissionsCISPR11Group1TheBP‐801WirelessBloodPressureMonitor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.REemissionsCISPR11ClassBHarmonicemissionsIEC61000‐3‐2NotapplicableTheBP‐801WirelessBloodPressureMonitorissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclow‐voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.Voltagefluctuations/FlickeremissionsIEC61000‐3‐3Notapplicable
Withings Blood Pressure Monitor User’s Guide 16Declaration–electromagneticemissionsandimmunityforequipmentandsystemsthatarenotlife‐supportingandarespecifiedforuseonlyinashieldedlocationTheWirelessBloodPressureMonitordeclaration‐electromagneticimmunityDeclaration–electromagneticimmunityTheWirelessBloodPressureMonitorsystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheWirelessBloodPressureMonitorsystemshouldassurethatitisusedinsuchanenvironment.TheWirelessBloodPressureMonitorsystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheWirelessBloodPressureMonitorsystemshouldassurethatitisusedinsuchanenvironment.ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment‐guidanceImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment‐guidanceElectrostaticdischarge(ESD)IEC61000‐4‐26kVcontact8kVair6kVcontact8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%.ConductedRFIEC61000‐4‐63Vrms150kHzto80MHzN/APortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartoftheEQUIPMENTorSYSTEMincludingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol.Electricalfasttransient/burstIEC61000‐4‐42kVforpowersupplylines1kVforinput/outputlinesN/AMainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.SurgeIEC61000‐4‐51kVdifferentialmode2kVcommonmodeN/AMainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.RadiatedRFIEC61000‐4‐33V/m80MHzto2.5GHzN/AVoltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlinesIEC61000‐4‐11‐5%UT(95%dipinUT)for0.5cycle‐40%UT(60%dipinUT)for5cycles‐70%UT(30%dipinUT)for25cycles‐5%UT(95%dipinUT)for5secN/AMainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.IftheuseroftheEQUIPMENTorSYSTEMrequirescontinuedoperationduringpowermainsinterruptions,itisrecommendedthattheEQUIPMENTorSYSTEMbepoweredfromanuninterruptiblepowersupplyorabattery.Powerfrequency(50/60Hz)magneticfieldIEC61000‐4‐83A/mN/APowerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.
Withings Blood Pressure Monitor User’s Guide 17DISPOSALActuationofEuropeandirectives2002/95/EC,2002/96/ECand2003/108/EC,forreductioninuseofdangeroussubstancesintheelectricandelectronicdeviceandforgarbagedisposal.Thesymbolappliedonthedeviceoritspackagingmeansthatattheendofitsusefullifetheproductmustnotbedisposedofwithdomesticwaste.Attheendofdevicesusefullife,theusermustdeliverittotheablecollectingcentersforelectricandelectronicgarbage,orgivebacktotheretailerwhenpurchasinganewdevice.Disposingoftheproductseparatelypreventspossiblenegativeconsequencesfortheenvironmentandforhealth,derivingfrominadequatedisposal.Italsoallowstherecoveryofmaterialsofwhichit’smadeupinordertoobtainanimportantsavingofenergyandresourcesandtoavoidnegativeeffectstotheenvironmentandhealth.Incaseofabusivedisposalofdevicebytheuser,willbeappliedadministrativeendorsementsincompliancewithcurrentstandard.Thedeviceanditspartsismaredwithregardtodisposal,asappropriate,inaccordancewithnationalorregionalregulations.SpecificationsTechnicaldataProductdescription:DigitalautomaticBloodPressureMonitorModel:BP‐801(Withings)Measurementmethod:CuffoscillometricmethodCuffinflation:Automaticinflationwithairpumpat15mmHg/sPressuresensor:GaugesensorMeasurementrange(pressure):0to285mmHgMeasurementrange(pulse):40to180beats/minAccuracy(pressure):Within+‐3mmHgor2%ofreadingAccuracy(pulse):Within+‐5%ofreadingSensor:SemiconductorpressuresensorOperatingconditions:10to40°C,15to90%RH,atmospheric86Kpa~106kpa,altitude:2000mStorageandtransportconditions:‐25to70°C,10to95%RH,atmospheric86Kpa~106kpa,altitude:2000mArmtype:Circumference22‐42cm(9”‐17”)Dimensions:150(L)x140(W)x100(H)Powersource:AAAalkalinecells(x4)Weight:Approx.600gwithoutcellsAccessories:AAAAlkalinecellsx4,Micro‐USBtoUSBadapter,InstructionmanualProductlife:5yearsWirelesstransmissionV4.0dualmode(V2.1+EDR)Note:Specificationsaresubjecttochangewithoutpriornoticeoranyobligationonthepartsofthemanufacturer
Withings Blood Pressure Monitor User’s Guide 18Usermanualv2.0‐Aug.,2013©2013Withings.Allrightsreserved.iPad,iPhoneandiPodtoucharetrademarksofAppleinc.

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