Otsuka America Pharmaceutical 06120 Proteus Patch, Model SPC-0800 User Manual2

Proteus Digital Health, Inc. Proteus Patch, Model SPC-0800 Users Manual2

Contents

Users Manual2

LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage1of1Effective:19DEC2013THEPROTEUSPATCHSPC‐0800USERSUPPLEMENTALINFORMATIONTableofContents1.TECHNICALINFORMATION................................................................................................................21.1–Classification....................................................................................................................................21.2–EnvironmentalConditions..........................................................................................................21.3–MinimizingSkinIrritation............................................................................................................21.4–ProtectionagainstIngressofSolidsandLiquids.................................................................21.5–AvoidingUnsafeUseConditions..............................................................................................21.6–InformationonElectromagneticandOtherInterferences...............................................31.7–InformationontheRadioSubsystem......................................................................................31.8–EuropeanR&TTEDeclarationofConformity.........................................................................71.9–CISPRInterferenceStatement....................................................................................................71.10–FCCInterferenceStatement.....................................................................................................81.11–FCCWirelessNotice.....................................................................................................................81.12–FCCIdentifier.................................................................................................................................82–DISPOSALOFWASTEPRODUCTS..................................................................................................83–MANUFACTURERCONTACTINFORMATION.............................................................................9
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage2of2Effective:19DEC20131.TECHNICALINFORMATION1.1–ClassificationCaution:Federal(U.S.A)lawrestrictsthisdevicetosalebyorontheorderofaphysician.TheProteusPatchiscategorizedasClassII(inUS)andIIa(inEU).TheUser(patient)istheintendedOperatoroftheProteusPatch.1.2–EnvironmentalConditionsTheProteus®Patchisintendedforstorageandoperationinaroom‐temperatureenvironment.ConditionTemperatureHumidityPressure(Altitude)Operating20C–28C 15%‐93%700hPa–1060hPaStorage20C–28C15%‐93%700hPa–1060hPaTransport2C–38C15%‐85%700hPa–1060hPa1.3–MinimizingSkinIrritationTheProteusPatchhasbeendesignedtominimizethepossibilityofskinirritation.ObservingthesecautionswillreducethelikelihoodofskinirritationorbruisingunderthePatch:DONOTcontinueuseuntilfurtherinstructionbyaphysicianifyourskinisirritatedorinflamedaroundthepatch.DONOTplaceinlocationswhereyourskinisscraped,cracked,inflamed,orirritated.DONOTplaceinalocationthatoverlapstheareaofthemostrecentlyremovedPatch.DONOTuseifyouareallergictoadhesivetape.DONOTwearthesamePatchformorethanoneweek.DONOTdroporbumpwithexcessiveforce.1.4–ProtectionagainstIngressofSolidsandLiquidsTheProteusPatchhasanIngressProtectionratingofIP27.Thismeansthattheenclosurehasnopenetrationsandithasbeenratedforimmersioninliquidupto1mdepth.Forcontinuedsafety,shouldtheenclosurebecomepenetratedortorn,removethePatchimmediatelyandreplaceitwithanewone.1.5–AvoidingUnsafeUseConditionsTheProteusPatchisnotadiagnosticdevice.DONOTattempttouseittodiagnoseheart‐relatedconditions,anincorrectdiagnosismayresult.
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage3of3Effective:19DEC2013TheProteusPatchhasnotbeentestedorapprovedassafeforoperationduringairtravel.DONOTusethePatchduringairtravel;itmayinterferewiththeaircraftnavigationalinstruments.TheProteusPatchhasnotbeentestedorapprovedforuseinthepresenceofstrongmagneticorelectricfields.DONOTwearthePatchduringmagneticresonanceimaging(MRI),cautery,andexternaldefibrillationprocedures.DamagetothePatch,yourskin,oranunexpectedmagneticattractionmayresult.PleaseinformyourhealthcareprofessionalthatthePatchmustberemovedpriortoengaginginoneoftheseprocedures.WARNING:Nomodificationofthisequipmentisallowed.ModifyingtheProteusPatchmaycauseasafetyhazardfortheuser.1.6–InformationonElectromagneticandOtherInterferencesTheProteusPatchhasbeenevaluatedanddeemedcompliantwiththerequirementsinEN60601‐1‐2ClassBforElectromagneticCompatibility(EMC).MedicalElectricalEquipmentneedsspecialprecautionsregardingEMCandneedstobeinstalledandputintoserviceaccordingtotheEMCinformationprovidedinthisUserManual.PortableandmobileRFcommunicationsequipmentcanaffectMedicalElectricalEquipment.TheProteusPatchshouldnotbeusedadjacenttoorstackedwithotherelectromagneticequipment.Ifadjacentorstackedusewithotherelectromagneticequipmentisnecessary,verifythattheProteusPatchoperationisnormalintheconfiguration(s)inwhichitwillbeused.1.7–InformationontheRadioSubsystemTheProteusPatchincorporatesaBluetoothTmradiosubsystemwhichiscompliantwiththeBluetoothstandard.ThefollowinginformationisprovidedtosatisfytherequirementsofEN/IEC60601‐1‐2:TheBluetoothradiotransmitsandreceiveson40frequencybandswhichareequallyspacedat2MHzintervalsbetween2402MHzand2480MHz.Theeffectivereceivebandwidthis1.25MHz.Thetransmitmodulationisfrequency‐hoppingusingGFSK(GaussianFrequencyShiftKeying)withabandwidth‐bitperiodproductBT=0.5.TheModulationindexisbetween0.28and0.35.Theeffectiveradiatedpoweris‐15dBm(P=0.032mW)Guidanceandmanufacturer’sdeclaration–electromagneticemissionsTheProteusPatchisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuserofProteusPatchshouldassurethatitisusedinsuchanenvironment.EmissionstestComplianceElectromagneticenvironment–guidanceRFemissionsCISPR11Group1ThePatchusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikely
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage4of4Effective:19DEC2013tocauseanyinterferenceinnearbyelectronicequipment.RFemissionsCISPR11ClassBThePatch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.HarmonicemissionsIEC61000‐3‐2NotapplicableVoltagefluctuations/flickeremissionsIEC61000‐3‐3Notapplicable
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage5of5Effective:19DEC2013Guidanceandmanufacturer’sdeclaration–electromagneticimmunityTheProteusPatchisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheProteusPatchshouldassurethatitisusedinsuchanenvironment.ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment–guidancePortableandmobileRFcommunicationsequipmentshouldbeGuidanceandmanufacturer’sdeclaration–electromagneticimmunityTheProteusPatchisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuserofthePatchshouldassurethatitisusedinsuchanenvironment.ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment–guidanceElectrostaticdischarge(ESD)IEC61000‐4‐2+/‐6kVcontact+/‐8kVair+/‐6kVcontact+/‐8kVairFloorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.Electricalfasttransient/burstIEC61000‐4‐4 +/‐2kVforpowersupplylines +/‐1kVforinput/outputlinesNotapplicableSurgeIEC61000‐4‐5+/‐1kVline(s)toline(s)+/‐2kVline(s)toearthNotapplicable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sNotapplicablePowerfrequency(50/60Hz)magneticfieldIEC61000‐4‐83A/m3A/mPowerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.NOTEUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage6of6Effective:19DEC2013ConductedRFIEC61000‐4‐6RadiatedRFIEC61000‐4‐33Vrms150kHzto80MHz3V/m80MHzto2,5GHzNotApplicable3V/musednoclosertoanypartoftheProteusPatch,includingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.RecommendedseparationdistanceNotApplicabled=1,17√P80MHzto800MHzd=2,33√P800MHzto2,5GHzwherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmetres(m).FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey,ashouldbelessthanthecompliancelevelineachfrequencyrange.bInterferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheProteusPatchisusedexceedstheapplicableRFcompliancelevelabove,theProteusPatchshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasre‐orientingorrelocatingtheProteusPatch.bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage7of7Effective:19DEC2013RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipmentandtheProteusPatchTheProteusPatchisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuserofthePatchcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheProteusPatchasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.RatedmaximumoutputpoweroftransmitterWSeparationdistanceaccordingtofrequencyoftransmitter150kHzto80MHzd=1,2√P80MHzto800MHzd=1,2√P800MHzto2.5GHzd=2,3√P0.01Notapplicable0.10.230.1Notapplicable0.40.741Notapplicable1.22.310Notapplicable3.77.4100Notapplicable1223Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.1.8–EuropeanR&TTEDeclarationofConformityHereby,Proteus®DigitalHealth,Inc.,declaresthattheProteusPatchisincompliancewiththeessentialrequirementsandotherrelevantprovisionsofR&TTE(RadioandTelecommunicationsTerminalEquipment)Directive1999/5/EC.Theproductiscompliantwiththefollowingstandardsand/orothernormativedocuments:Safety(art.3.1a):EN60601‐1,3rdEd,IEC60601‐1‐11EMC(art.3.1b):EN301489‐17v2.2.1Spectrum(art.3.2):EN300328v1.8.1Other:EN60601‐1‐2(2007)TheProteusPatchcanbeusedincountriesintheEuropeanUnion.1.9–CISPRInterference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thissectionofthemanual.PortableandmobileRFcommunicationsequipmentcanaffectMEDICALELECTRICAL
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage8of8Effective:19DEC2013EQUIPMENT.TheProteusPatchmaybeinterferedwithbyotherequipment,evenifthatequipmentcomplieswithCISPRemissionrequirements.1.10–FCCInterferenceStatement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.ChangesormodificationsnotexpresslyapprovedbyProteusDigitalHealthcouldvoidyourauthoritytooperatetheequipment.1.11–FCCWirelessNoticeThisproductemitsradiofrequencyenergy,buttheradiatedoutputpowerofthisdeviceisfarbelowtheFCCradiofrequencyexposurelimits.Note:ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttopart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonable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.1.12–FCCIdentifierFCCID:X79061202–DISPOSALOFWASTEPRODUCTSProductionofthisequipmentrequiredtheextractionanduseofnaturalresources.Theequipmentmaycontainsubstancesthatcouldbeharmfultotheenvironmentorhumanhealthifimproperlyhandledattheproduct’sendoflife.Inordertoavoidreleaseofsuchsubstancesintotheenvironmentandtoreducetheuseofnaturalresources,alldevices,bothusedandunused,shouldnotbedisposedwithhouseholdwaste.Returntoarecyclingpointforelectricandelectronicdevices.
LBL‐0176,Rev1|UserSupplementalInformation,Proteus®PatchPage9of9Effective:19DEC20133–MANUFACTURERCONTACTINFORMATIONTorequesttechnicalinformationortoreportunexpectedevents,pleasecontactthemanufactureratoneoftheselocations.UnitedStatesProteusDigitalHealth,Inc2600BridgeParkway,Suite101RedwoodCity,CA94065PhoneNumber:650‐632‐4031FaxNumber:650‐632‐4071UnitedKingdom ProteusDigitalHealthUKLtd6thFloor,41‐44GreatQueenSt.LondonWC2B5AD

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