THEPROTEUSPATCH SPC0800 USERSUPPLEMENTALINFORMATION TableofContents 1.TECHNICALINFORMATION ................................................................................................................ 2 1.1Classification .................................................................................................................................... 2 1.2EnvironmentalConditions .......................................................................................................... 2 1.3MinimizingSkinIrritation ............................................................................................................ 2 1.4ProtectionagainstIngressofSolidsandLiquids ................................................................. 2 1.5AvoidingUnsafeUseConditions .............................................................................................. 2 1.6InformationonElectromagneticandOtherInterferences ............................................... 3 1.7InformationontheRadioSubsystem ...................................................................................... 3 1.8EuropeanR&TTEDeclarationofConformity ......................................................................... 7 1.9CISPRInterferenceStatement .................................................................................................... 7 1.10FCCInterferenceStatement ..................................................................................................... 8 1.11FCCWirelessNotice ..................................................................................................................... 8 1.12FCCIdentifier ................................................................................................................................. 8 2DISPOSALOFWASTEPRODUCTS .................................................................................................. 8 3MANUFACTURERCONTACTINFORMATION ............................................................................. 9 LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page1of1 Effective:19DEC2013 1.TECHNICALINFORMATION 1.1Classification Caution:Federal(U.S.A)lawrestrictsthisdevicetosalebyorontheorderofaphysician. TheProteusPatchiscategorizedasClassII(inUS)andIIa(inEU). TheUser(patient)istheintendedOperatoroftheProteusPatch. 1.2EnvironmentalConditions TheProteusPatchisintendedforstorageandoperationinaroomtemperatureenvironment. Condition Operating Storage Transport 1.3MinimizingSkinIrritation TheProteusPatchhasbeendesignedtominimizethepossibilityofskinirritation.Observingthese cautionswillreducethelikelihoodofskinirritationorbruisingunderthePatch:
Pressure(Altitude) 700hPa1060hPa 700hPa1060hPa 700hPa1060hPa Temperature 20C28C 20C28C 2C38C Humidity 15%93%
15%93%
15%85%
DO NOT continue use until further instruction by a physician if your skin is irritated or inflamedaroundthepatch. DONOTplaceinlocationswhereyourskinisscraped,cracked,inflamed,orirritated. DONOTplaceinalocationthatoverlapstheareaofthemostrecentlyremovedPatch. DONOTuseifyouareallergictoadhesivetape. DONOTwearthesamePatchformorethanoneweek. DONOTdroporbumpwithexcessiveforce. 1.4ProtectionagainstIngressofSolidsandLiquids TheProteusPatchhasanIngressProtectionratingofIP27.Thismeansthattheenclosurehasno penetrationsandithasbeenratedforimmersioninliquidupto1mdepth.Forcontinuedsafety, shouldtheenclosurebecomepenetratedortorn,removethePatchimmediatelyandreplaceitwith anewone. 1.5AvoidingUnsafeUseConditions TheProteusPatchisnotadiagnosticdevice.DONOTattempttouseittodiagnoseheartrelated conditions,anincorrectdiagnosismayresult. LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page2of2 Effective:19DEC2013 TheProteusPatchhasnotbeentestedorapprovedassafeforoperationduringairtravel.DONOT usethePatchduringairtravel;itmayinterferewiththeaircraftnavigationalinstruments. TheProteusPatchhasnotbeentestedorapprovedforuseinthepresenceofstrongmagneticor 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 attractionmayresult.PleaseinformyourhealthcareprofessionalthatthePatchmustberemoved priortoengaginginoneoftheseprocedures. WARNING:Nomodificationofthisequipmentisallowed.ModifyingtheProteusPatchmaycausea safetyhazardfortheuser. 1.6InformationonElectromagneticandOtherInterferences TheProteusPatchhasbeenevaluatedanddeemedcompliantwiththerequirementsinEN606011 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 informationprovidedinthisUserManual.PortableandmobileRFcommunicationsequipmentcan affectMedicalElectricalEquipment.TheProteusPatchshouldnotbeusedadjacenttoorstacked with other electromagnetic equipment. If adjacent or stacked use with other electromagnetic equipmentisnecessary,verifythattheProteusPatchoperationisnormalintheconfiguration(s)in whichitwillbeused. 1.7InformationontheRadioSubsystem 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 6060112:
The Bluetooth radio transmits and receives on 40 frequency bands which are equally spaced at 2MHzintervalsbetween2402MHzand2480MHz. Theeffectivereceivebandwidthis1.25MHz. ThetransmitmodulationisfrequencyhoppingusingGFSK(GaussianFrequencyShiftKeying)witha bandwidthbitperiodproductBT=0.5.TheModulationindexisbetween0.28and0.35. Theeffectiveradiatedpoweris15dBm(P=0.032mW) Guidanceandmanufacturersdeclarationelectromagneticemissions The Proteus Patch is intended for use in the electromagnetic environment specified below. The customerortheuserofProteusPatchshouldassurethatitisusedinsuchanenvironment. Emissionstest Electromagneticenvironmentguidance RFemissions CISPR11 ThePatchusesRFenergyonlyforitsinternalfunction. Therefore,itsRFemissionsareverylowandarenotlikely Compliance Group1 LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page3of3 Effective:19DEC2013 tocauseanyinterferenceinnearbyelectronicequipment. ThePatchissuitableforuseinallestablishments, includingdomesticestablishmentsandthosedirectly connectedtothepubliclowvoltagepowersupply networkthatsuppliesbuildingsusedfordomestic purposes. RFemissions CISPR11 Harmonic emissions IEC6100032 Voltage fluctuations/
flickeremissions IEC6100033 ClassB Notapplicable Notapplicable LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page4of4 Effective:19DEC2013 Guidanceandmanufacturersdeclarationelectromagneticimmunity The Proteus Patch is intended for use in the electromagnetic environment specified below. The customerortheuserofthePatchshouldassurethatitisusedinsuchanenvironment. Immunitytest Electromagneticenvironment IEC60601testlevel Compliance Electrostatic discharge(ESD)IEC 6100042
+/6kVcontact
+/8kVair
+/2kVforpower supplylines
+/1kVfor input/output lines
+/1kVline(s)to line(s)
+/2kVline(s)toearth
<5%UT(>95%dipin UT) for0,5cycle 40%UT(60%dipinUT) for5cycles 70%UT(30%dipinUT) for25cycles
<5%UT(>95%dipin UT) for5s 3A/m Electricalfast transient/burst IEC6100044 SurgeIEC610004 5 Voltagedips,short interruptionsand voltagevariations onpowersupply inputlines IEC61000411 Powerfrequency
(50/60Hz) magneticfield IEC6100048 level
+/6kV contact
+/8kVair Notapplicable guidance Floorsshouldbewood,concrete orceramictile.Iffloorsare coveredwithsyntheticmaterial, therelativehumidityshouldbeat least30%. Notapplicable Notapplicable 3A/m Powerfrequencymagneticfields shouldbeatlevelscharacteristic ofatypicallocationinatypical commercialorhospital environment. NOTEUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel. Guidanceandmanufacturersdeclarationelectromagneticimmunity TheProteusPatchisintendedforuseintheelectromagneticenvironmentspecifiedbelow.The customerortheuseroftheProteusPatchshouldassurethatitisusedinsuchanenvironment. Electromagneticenvironment Immunitytest guidance PortableandmobileRF communicationsequipmentshouldbe Compliance level IEC60601 testlevel LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page5of5 Effective:19DEC2013 ConductedRF IEC6100046 RadiatedRF IEC6100043 3Vrms 150kHzto80 MHz 3V/m 80MHzto2,5GHz Not Applicable 3V/m usednoclosertoanypartofthe ProteusPatch,includingcables,than therecommendedseparation distancecalculatedfromtheequation applicabletothefrequencyofthe transmitter. Recommendedseparationdistance NotApplicable d=1,17P80MHzto800MHz d=2,33P800MHzto2,5GHz wherePisthemaximumoutput powerratingofthetransmitterin watts(W)accordingtothetransmitter manufactureranddisthe recommendedseparationdistancein metres(m). FieldstrengthsfromfixedRF transmitters,asdeterminedbyan electromagneticsitesurvey,ashould belessthanthecompliancelevelin eachfrequencyrange.b Interferencemayoccurinthevicinity ofequipmentmarkedwiththe followingsymbol:
NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies. NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedby absorptionandreflectionfromstructures,objectsandpeople. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcast cannotbepredictedtheoreticallywithaccuracy.Toassesstheelectromagneticenvironmentdueto fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strengthin thelocationinwhichthe ProteusPatchisusedexceeds theapplicableRF compliance level above, the Proteus Patch should be observed to verify normal operation. If abnormal performanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocating theProteusPatch. bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m. LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page6of6 Effective:19DEC2013 Recommendedseparationdistancesbetweenportableandmobile RFcommunicationsequipmentandtheProteusPatch 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 electromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRF communications equipment (transmitters) and the Proteus Patch as recommended below, accordingtothemaximumoutputpowerofthecommunicationsequipment. Ratedmaximum outputpowerof transmitter W 0.01 0.1 1 10 100 Separationdistanceaccordingtofrequencyoftransmitter 150kHzto80MHz 80MHzto800MHz 800MHzto2.5GHz d=1,2P Notapplicable Notapplicable Notapplicable Notapplicable Notapplicable d=1,2P d=2,3P 0.1 0.4 1.2 3.7 12 0.23 0.74 2.3 7.4 23 Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparation distancedinmeters(m) canbeestimatedusingtheequationapplicableto thefrequencyofthe transmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)according tothetransmittermanufacturer. NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies. NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedby absorptionandreflectionfromstructures,objectsandpeople. 1.8EuropeanR&TTEDeclarationofConformity 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/orothernormativedocuments:
Safety(art.3.1a):
EMC(art.3.1b):
Spectrum(art.3.2):
Other:
EN606011,3rdEd,IEC60601111 EN30148917v2.2.1 EN300328v1.8.1 EN6060112(2007) TheProteusPatchcanbeusedincountriesintheEuropeanUnion. 1.9CISPRInterferenceStatement 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 LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page7of7 Effective:19DEC2013 EQUIPMENT.TheProteusPatchmaybeinterferedwithbyotherequipment,evenifthatequipment complieswithCISPRemissionrequirements. 1.10FCCInterferenceStatement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:(1)thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemustacceptany interference received, including interference that may cause undesired operation. Changes or modificationsnotexpresslyapprovedbyProteusDigitalHealthcouldvoidyourauthoritytooperate theequipment. 1.11FCCWirelessNotice Thisproductemitsradiofrequencyenergy,buttheradiatedoutputpowerofthisdeviceisfarbelow theFCCradiofrequencyexposurelimits. Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuanttopart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotection against harmful interference in a residential installation. This equipment generates, uses and can radiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions, 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 interferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoff andon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowing measures:
Reorientorrelocatethereceivingantenna. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiveris Increasetheseparationbetweentheequipmentandreceiver. connected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. 1.12FCCIdentifier FCCID:X7906120 2DISPOSALOFWASTEPRODUCTS Productionofthisequipmentrequiredtheextractionanduseofnaturalresources.Theequipment maycontainsubstancesthatcouldbeharmfultotheenvironmentorhumanhealthifimproperly handled at the products end of life. In order to avoid release of such substances into the environmentandtoreducetheuseofnaturalresources,alldevices,bothusedandunused,should not be disposed with household waste. Return to a recycling point for electric and electronic devices. LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page8of8 Effective:19DEC2013 3MANUFACTURERCONTACTINFORMATION Torequesttechnicalinformationortoreportunexpectedevents,pleasecontactthemanufacturer atoneoftheselocations. UnitedStates ProteusDigitalHealth,Inc 2600BridgeParkway,Suite101 RedwoodCity,CA94065 PhoneNumber:6506324031 FaxNumber:6506324071 UnitedKingdom ProteusDigitalHealthUKLtd 6thFloor,4144GreatQueenSt. LondonWC2B5AD LBL0176,Rev1|UserSupplementalInformation, ProteusPatch Page9of9 Effective:19DEC2013