Proteus Digital Health X7906120 User manual

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

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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

C–28C

15%‐93%

700hPa–1060hPa

Storage

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

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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heal thcare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 Bluetooth

 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1.25 MHz. 

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,

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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

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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,

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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fre quency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  electroma gnetic 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.



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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re commendedseparation

distance d in meters (m) can be estima ted  using the equation applicable to the frequency of the

transmitter,wherePisthemaximumoutputpowe r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,3

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caus e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fa r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 harm ful 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. How ever, there is no guarantee that

interference will not occur in a particular installation. If this equipment does cause harmful

interferencetoradioortelevisionrece ption,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CON TACT 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



Proteus Digital Health X7906120, SPC-0800 User manual

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