Proteus X7906120 User manual

Type
User manual

This manual is also suitable for

LBL0176,Rev1|UserSupplementalInformation,
Proteus®Patch
Page1of1 Effective:19DEC2013
THEPROTEUSPATCH
SPC0800
USERSUPPLEMENTALINFORMATION
TableofContents
1.TECHNICALINFORMATION................................................................................................................2
1.1Classification....................................................................................................................................2
1.2EnvironmentalConditions..........................................................................................................2
1.3MinimizingSkinIrritation............................................................................................................2
1.4ProtectionagainstIngressofSolidsandLiquids.................................................................2
1.5AvoidingUnsafeUseConditions..............................................................................................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,
Proteus®Patch
Page2of2 Effective:19DEC2013
1.TECHNICALINFORMATION
1.1Classification
Caution:Federal(U.S.A)lawrestrictsthisdevicetosalebyorontheorderofaphysician.
TheProteusPatchiscategorizedasClassII(inUS)andIIa(inEU).
TheUser(patient)istheintendedOperatoroftheProteusPatch.
1.2
EnvironmentalConditions
TheProteus®Patchisintendedforstorageandoperationinaroomtemperatureenvironment.
Condition Temperature Humidity Pressure(Altitude)
Operating
20
C28C
15%‐93%
700hPa1060hPa
Storage
20
C28C
15%‐93%
700hPa1060hPa
Transport
2
C38C
15%‐85%
700hPa1060hPa
1.3MinimizingSkinIrritation
TheProteusPatchhasbeen designed to minimizethepossibilityofskinirritation.Observingthese
cautionswillreducethelikelihoodofskinirritationorbruisingunderthePatch:
DO NOT continue use until further instruction by a physician if your skin is irritated or
inflamedaroundthepatch.
DONOTplace
inlocationswhereyourskinisscraped,cracked,inflamed,orirritated.
DONOTplaceinalocationthatoverlapstheareaofthemostrecentlyremovedPatch.
DONOTuseifyouareallergictoadhesivetape.
DONOTwearthesamePatchformorethanoneweek.
DONOT
droporbumpwithexcessiveforce.
1.4ProtectionagainstIngressofSolidsandLiquids
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,
shouldtheenclosurebecomepenetratedortorn,removethePatchimmediatelyandreplaceitwith
anew
one.
1.5AvoidingUnsafeUseConditions
The Proteus Patch is not a diagnostic device. DO NOT attempt to use it to diagnose heartrelated
conditions,anincorrectdiagnosismayresult.
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Proteus®Patch
Page3of3 Effective:19DEC2013
TheProteusPatchhasnotbeentestedorapprovedassafeforoperationduringairtravel.DONOT
usethePatchduringairtravel;itmayinterferewiththeaircraftnavigationalinstruments.
The Proteus Patch hasnot been tested or approved for use in the presence ofstrong 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.Pleaseinformyourheal thcareprofessionalthatthePatch must be removed
priortoengaginginoneoftheseprocedures.
WARNING:No
modificationofthisequipmentisallowed.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
informationprovided in thisUser Manual. Portableandmobile RFcommunicationsequipment 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
equipmentisnecessary,verifythattheProteusPatchoperationisnormalin theconfiguration(s)in
whichitwillbeused.
1.7InformationontheRadioSubsystem
The Proteus Patch incorporates a Bluetooth
Tm
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.
Theeffectivereceivebandwidthis1.25 MHz.
ThetransmitmodulationisfrequencyhoppingusingGFSK(GaussianFrequencyShiftKeying)witha
bandwidthbitperiodproductBT=0.5.TheModulation index is between0.28and0.35.
Theeffectiveradiatedpoweris
15dBm(P=0.032mW)
Guidanceandmanufacturer’sdeclarationelectromagneticemissions
The Proteus Patch is intended for use in the electromagnetic environment specified below.The
customerortheuserofProteusPatchshouldassurethatitisusedinsuchanenvironment.
Emissionstest Compliance Electromagneticenvironmentguidance
RFemissions
CISPR11
Group1
ThePatchusesRFenergyonlyforitsinternalfunction.
Therefore,itsRFemissionsareverylowandarenotlikely
LBL0176,Rev1|UserSupplementalInformation,
Proteus®Patch
Page4of4 Effective:19DEC2013
tocauseanyinterferenceinnearbyelectronicequipment.
RFemissions
CISPR11
ClassB ThePatchissuitableforuseinallestablishments,
includingdomesticestablishmentsandthosedirectly
connectedtothepubliclowvoltagepowersupply
networkthatsuppliesbuildingsusedfordomestic
purposes.
Harmonic
emissions
IEC6100032
Notapplicable
Voltage
fluctuations/
flickeremissions
IEC6100033
Notapplicable
LBL0176,Rev1|UserSupplementalInformation,
Proteus®Patch
Page5of5 Effective:19DEC2013
Guidanceandmanufacturer’sdeclarationelectromagneticimmunity
TheProteusPatchisintendedforuseintheelectromagneticenvironmentspecifiedbelow.The
customerortheuseroftheProteusPatchshouldassurethatitisusedinsuchanenvironment.
Immunitytest IEC60601
testlevel
Compliance
level
Electromagneticenvironment
guidance
PortableandmobileRF
communicationsequipmentshouldbe
Guidanceandmanufacturer’sdeclarationelectromagneticimmunity
The Proteus Patch is intended for use in the electromagnetic environment specified below. The
customerortheuserofthePatchshouldassurethatitisusedinsuchanenvironment.
Immunitytest IEC60601testlevel Compliance
level
Electromagneticenvironment
guidance
Electrostatic
discharge(ESD)IEC
6100042
+/‐6kVcontact
+/‐8kVair
+/‐6kV
contact
+/‐8kVair
Floorsshouldbewood,concrete
orceramictile.Iffloorsare
coveredwithsyntheticmaterial,
therelativehumidityshouldbeat
least30%.
Electricalfast
transient/burst
IEC6100044
+/‐2kVforpower
supplylines
+/‐1kVfor
input/output
lines
Notapplicable
SurgeIEC610004
5
+/‐1kVline(s)to
line(s)
+/‐2kVline(s)toearth
Notapplicable
Voltagedips,short
interruptionsand
voltagevariations
onpowersupply
inputlines
IEC61000411
<5%UT(>95%dip in
UT)
for0,5cycle
40%UT(60%dipinUT)
for5cycles
70%UT(30%dipinUT)
for25cycles
<5%
UT(>95%dipin
UT)
for5s
Notapplicable
Powerfrequency
(50/60Hz)
magneticfield
IEC6100048
3A/m 3A/m Powerfrequencymagneticfields
shouldbeatlevelscharacteristic
ofatypicallocationinatypical
commercialorhospital
environment.
NOTEUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
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Proteus®Patch
Page6of6 Effective:19DEC2013
ConductedRF
IEC6100046
RadiatedRF
IEC6100043
3Vrms
150kHzto80
MHz
3V/m
80MHzto2,5GHz
Not
Applicable
3V/m
usednoclosertoanypartofthe
ProteusPatch,includingcables,than
therecommendedseparation
distancecalculatedfromtheequation
applicabletothefre quencyofthe
transmitter.
Recommendedseparationdistance
NotApplicable
d=1,17P80MHzto800MHz
d=2,33P800MHzto2,5GHz
wherePisthemaximumoutput
powerratingofthe
transmitterin
watts(W)accordingtothetransmitter
manufactureranddisthe
recommendedseparationdistancein
metres(m).
FieldstrengthsfromfixedRF
transmitters,asdeterminedbyan
electromagneticsitesurvey,
a
should
belessthanthecompliancelevelin
eachfrequencyrange.
b
Interferencemayoccurinthevicinity
ofequipmentmarkedwiththe
followingsymbol:
NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagnetic propagationisaffectedby
absorptionandreflectionfromstructures,objectsandpeople.
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
cannotbepredictedtheoreticallywithaccuracy.To assesstheelectromagneticenvironmentdueto
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
performanceisobserved,additional measuresmay benecessary,suchas reorienting orrelocating
theProteusPatch.
b
Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.
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Proteus®Patch
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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
electromagneticinterferencebymaintaining a minimum distancebetweenportableandmobileRF
communications equipment (transmitters) and the Proteus Patch as recommended below,
accordingtothemaximumoutputpowerofthecommunicationsequipment.
Ratedmaximum
outputpowerof
transmitter
W
Separationdistanceaccordingtofrequencyoftransmitter
150kHzto80MHz
d=1,2P
80MHzto800MHz
d=1,2P
800MHzto2.5GHz
d=2,3P
0.01 Notapplicable 0.1 0.23
0.1 Notapplicable 0.4 0.74
1 Notapplicable 1.2 2.3
10 Notapplicable 3.7 7.4
100 Notapplicable 12 23
Fortransmittersratedatamaximumoutputpowernotlistedabove,there commendedseparation
distance d in meters (m) can be estima ted using the equation applicable to the frequency of the
transmitter,wherePisthemaximumoutputpowe rratingofthetransmitterinwatts(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): EN606011,3
rd
Ed,IEC60601111
EMC(art.3.1b): EN30148917v2.2.1
Spectrum(art.3.2): EN300328v1.8.1
Other: 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,
Proteus®Patch
Page8of8 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)thisdevicemaynotcaus eharmfulinterference,and(2)thisdevicemustacceptany
interference received, including interference that may cause undesired operation. Changes or
modifications
notexpresslyapprovedbyProteusDigitalHealthcouldvoidyour authoritytooperate
theequipment.
1.11FCCWirelessNotice
Thisproductemitsradiofrequencyenergy,buttheradiatedoutputpowerofthisdeviceisfa rbelow
theFCCradiofrequencyexposurelimits.
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
interferencetoradioortelevisionrece ption,whichcanbedeterminedbyturningtheequipmentoff
and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
Reorientorrelocatethereceivingantenna.
Increasetheseparationbetweentheequipmentandreceiver.
Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiver
is
connected.
Consultthedealeroranexperiencedradio/TVtechnicianforhelp.
1.12FCCIdentifier
FCCID:X7906120
2DISPOSALOFWASTEPRODUCTS
Productionofthis equipmentrequiredtheextractionanduse ofnaturalresources.Theequipment
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
environmentandtoreducetheuseofnaturalresources,alldevices,bothusedandunused,should
not be disposed with household waste. Return to a recycling point for electric and electronic
devices.
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Proteus®Patch
Page9of9 Effective:19DEC2013
3MANUFACTURERCON TACT INFORMATION
Torequesttechnicalinformationortoreportunexpectedevents, pleasecontactthemanufacturer
atoneoftheselocations.

UnitedStates
ProteusDigitalHealth,Inc
2600BridgeParkway,Suite101
RedwoodCity,CA94065
PhoneNumber:6506324031
Fax
Number:6506324071
UnitedKingdom

ProteusDigitalHealthUKLtd
6
th
Floor,4144GreatQueenSt.
LondonWC2B5AD
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Proteus X7906120 User manual

Type
User manual
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