User's Manual
LBL‐0176,Rev1|UserSupplementalInformation,
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.
1.6–InformationonElectromagneticandOtherInterferences
TheProteusPatchhasbeenevaluatedanddeemedcompliantwiththerequirementsinEN60601‐1‐
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
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.
1.7–InformationontheRadioSubsystem
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
60601‐1‐2:
The Bluetooth radio transmits and receives on 40 frequency bands which are equally spaced at
2MHzintervalsbetween2402MHzand2480MHz.
Theeffectivereceivebandwidthis1.25 MHz.
Thetransmitmodulationisfrequency‐hoppingusingGFSK(GaussianFrequencyShiftKeying)witha
bandwidth‐bitperiodproductBT=0.5.TheModulation index is between0.28and0.35.
Theeffectiveradiatedpoweris
‐15dBm(P=0.032mW)
Guidanceandmanufacturer’sdeclaration–electromagneticemissions
The Proteus Patch is intended for use in the electromagnetic environment specified below.The
customerortheuserofProteusPatchshouldassurethatitisusedinsuchanenvironment.
Emissionstest Compliance Electromagneticenvironment–guidance
RFemissions
CISPR11
Group1
ThePatchusesRFenergyonlyforitsinternalfunction.
Therefore,itsRFemissionsareverylowandarenotlikely