Withings WPM02 Blood Pressure Monitor User Manual 20130826 BP801 manuel SGSx

Withings Blood Pressure Monitor 20130826 BP801 manuel SGSx

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Withings

BloodPressureMonitor



Version2.0

AUG.2013

Withings Blood Pressure Monitor User’s Guide



2

Withings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

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In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

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Intended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

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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

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Withings Blood Pressure Monitor User’s Guide

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5

Table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

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6

About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.

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Withings Blood Pressure Monitor User’s Guide

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7

Installation



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



8

How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



9

Begin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



10

Using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



11

After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



12

Error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



13

Troubleshooting



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



14

FCC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



15

RF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emissions

The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

Compl

iance

level

Electromagnetic

environment‐

guidance

Immunity

test

IEC

60601

testlevel

Compli

ance

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

communication

s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



17

DISPOSAL

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

iPad,iPhoneandiPodtoucharetrademarksofAppleinc.

Withings WPM02 Blood Pressure Monitor User Manual 20130826 BP801 manuel SGSx

Withings Blood Pressure Monitor 20130826 BP801 manuel SGSx

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