User's Manual
Withings Blood Pressure Monitor User’s Guide
2
WithingsisthetrademarkofthisproductandallothertrademarksorWebsitementionedinthis
documentarethepropertiesoftheirrespectiveowners.
Disclaimer
Informationinthisguidemaychangewithoutnotice.Themanufacturerassumesnoresponsibilities
forerrorsthatmayappearinthisguide.
ReferencetoStandards
Thisdevicecomplieswiththefollowingnormativedo
cuments:
COUNCILDIRECTIVE93/42/EECof14June1993concerningmedicaldevicesasamendedbyDirective2007/47/EC
*ENISO13485:2003/AC:2009:Medicaldevices‐Qualitymanagementsystems–Requirementsforregulatory
purposes(ISO13485:2003)Referencetostandardscontd.
*ENISO14971:2012:Medicaldevices‐Applicationofriskmanagementtomedicaldevices(ISO14971:2007,
Cor
rectedversion2007‐10‐01)
*IEC60601‐1:2005+CORR.1(2006)+CORR.2(2007);EN60601‐1:2006+AC(2010):
Medicalelectricalequipment‐Part1:GeneralrequirementsforbasicsafetyandessentialPerformance
*EN1060‐3:1997+A1:2005+A2:2009:Non‐invasivesphygmomanometers,Part3:Supplementaryrequirements
forelectromechanicalbloodpressuremeasuringsystems
*EN106
0‐4:2004Non‐invasivesphygmomanometers.Testprocedurestodeterminetheoverallsystem
accuracyofautomatednon‐invasivesphygmomanometers.
*IEC/EN60601‐1‐11:Generalrequirementsforbasicsafetyandessentialperformance–CollateralStandard:
Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcare
environment
*IEC80
601‐2‐30:2009(FirstEdition)foruseinconjunctionwithIEC60601‐1:2005
EN80601‐2‐30:2010/ANSI/AAMI80601‐2‐30:2009:Particularrequirementsforthebasicsafetyand
essentialperformanceofautomatednon‐invasivesphygmomanometers
*EN300328V1.8.1ElectromagneticcompatibilityandRadiospectrumMatters(ERM);W
idebandtransmission
systems;Datatransmissionequipmentoperatinginthe2,4GHzISMbandandusingwidebandmodulation
techniques;HarmonizedENcoveringtheessentialrequirementsofarticle3.2oftheR&TTEDirective
*EN301489‐1‐3V1.9.2(2011)ElectromagneticcompatibilityandRadiospectrumMatters(ERM);
ElectroMagneticCompatibility(EMC)standardforrad
ioequipmentandservices;Part1:Commontechnicalrequirements
*EN301489‐1‐17V2.2.1(2012)ElectromagneticcompatibilityandRadiospectrumMatters(ERM);
ElectroMagneticCompatibility(EMC)standardforradioequipmentandservices;
Part1:Commontechnicalrequirements
*EN60601‐1‐2:2007CISPR:2011:Medicalelectricalequipment:Part1‐2:Generalrequirementsforbasi
c
safetyandessentialperformance‐collateralstandardelectromagneticcompatibility
*EN55011:2009/A1:2010:Industrial,scientificandmedicalequipment‐Radio‐frequencydisturbance
characteristics‐Limitsandmethodsofmeasurement
*FCCpartB15B:2013ElectromagneticCompatibility
FCCRulePart:15.247Cat:DSS(Bluetooth)FCCRulePart:15.247Cat:DTS(BT4.0)
*ENISO1
0993‐1:2009Biologicalevaluationofmedicaldevices‐Part1:Evaluationandtestingwithin
ariskmanagementprocess(ISO10993‐1:2009)
*ANSI/AAMISP10:2002/A12003(R)2008:Manual,electronicorautomatedsphygmomanometers
*ANSI/AAMI/ISO81060‐2:2009Non‐invasivesphygmomanometersPart2:Clinicalvalidationofautomated
measurementtype
Requirements
2013
USImporter:WithingsInc.
16192CoastalHighwayLewesDE19
KahlHandelsvertretung
Add.:Isarstr.3340699Erkrath,Germany
Tel:+49210447754
WithingsSAS
20bisrueRougetdeLisle
92130Issy‐les‐Moulineaux
TypeBFAppliedPart(cuff)
WEEE
IP22Ingressofwaterorparticulate
matter
FCCID:XNAWPM02
EUREPRESENTATIVE