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

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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

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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

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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

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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

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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,

should

belessthanthecompliancelevelin

eachfrequencyrange.



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.

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.



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

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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

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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

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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



Floor,41‐44GreatQueenSt.

LondonWC2B5AD



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

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