User's Manual

SpinalModulation,Inc. PhysicianImplantManual
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PercutaneousExtensionTunneling–ImplantLeadTrialOnly ........................................32
RemovingLeadExtension–ImplantLeadTrialOnly ......................................................33
CreatingtheINSPocket–Implant..................................................................................34
LeadorExtensionTunneling ..........................................................................................35
ConnectingLeadtoExtension ........................................................................................35
ConnectingtheINS.........................................................................................................36
ImplantingtheINS .........................................................................................................37
CheckingSystemIntegrity..............................................................................................38
CompletingtheProcedure .............................................................................................38
REPLACINGANINS ......................................................................................................................38
DisposingofanExplantedDevice...................................................................................39
A
PPENDIXA:TRIALLEADKIT/IMPLANTLEADKIT .............................................................................40
HowSupplied.................................................................................................................40
PackageContents...........................................................................................................40
DeviceSpecification .......................................................................................................41
APPENDIXB:TRIALNEUROSTIMULATOR ..........................................................................................42
DeviceDescription .........................................................................................................42
PackageContents...........................................................................................................42
DeviceSpecifications .....................................................................................................42
Handling ........................................................................................................................43
APPENDIXC:IMPLANTABLENEUROSTIMULATOR ................................................................................44
HowSupplied.................................................................................................................44
DeviceDescription .........................................................................................................44
PackageContents...........................................................................................................44
DeviceSpecifications .....................................................................................................44
Handling ........................................................................................................................45
DeviceLongevity............................................................................................................45
COMPANYANDAUTHORIZEDREPRESENTATIVECONTACTINFORMATION ..................................................46
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