User's Manual

SpinalModulation,Inc. PhysicianImplantManual
5
Limitedwaterproof.AppliestotheTNS
AppliestotheProgrammerinitscarryingcase
ContentsofPackageareNonSterile
KeepDry
Storagetemperature
Storebetween10%and90%humidity
SterileComponents
Storebetween0%and93%humidity
TNSandProgrammers
Thedeviceisaradiotransmitter
Magnet.ShowsthelocationoftheProgrammermagnet.
AuthorizedEuropeanRepresentative
RFOperatingFrequencies.Nearbyequipmentemittingstrongmagneticfieldscaninterferewith
RFcommunication,eveniftheotherequipmentcomplieswithCISPRemissionrequirements.The
operatingcharacteristicsareasfollows:
MICS/MedRadio band: 402405 MHz. The effective radiated power is below the limits as
specifiedin
Europe:ENETSI3018392
USAFCC47CFRPart95;95.60195.673SubpartE,95.120195.1219
FCCID:Y8LMN0200
This device may not interfere with stations operating in the 400.150–406.000 MHz band in the
Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must
acceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.
Introduction
This manual describes the Axium™ Neurostimulator System, including instructions for
implantation.Fordetailedoperationandclinicalprogramminginstructions,refertotheClinical
ProgrammerManual.