User's Manual
SpinalModulation,Inc. PhysicianImplantManual
15
Warnings–ForUseinHomeorWorkEnvironments
• Equipment Operation – During stimulation, patients should be advised to not operate
potentially dangerous equipment, such as power tools, automobiles, or other motor
vehicles.Theyshouldnotclimbladdersorparticipateinotheractivitieswherepostural
changeoran abrupt movement could alter theperceptionof stimulation intensity and
causepatientstofallorlosecontrolofequipmentorvehiclesorinjureothers.
• PatientActivity–Patientsshouldbeadvisedtolimittheiractivitiestolowormoderate
levelsduringtheirtrialstimulationperiodandthefirstsixweeksofimplantationofthe
INS.Failure to do so may result in migration of the leads causing loss of stimulation
therapy, muscle stimulation or painful stimulation thereby requiring reoperation to
reposition.
• TheftDetectorsandMetalScreeningDevices –Certaintypesofantitheftdevices,such
as those used at entrances/exits of department stores, libraries, and other public
establishments, and/or airport security screening devices may affect stimulation. It is
possible that patients who are implanted with non‐adjacent multiple leads and/or
patientswho are sensitivetolow stimulation thresholdsmay experiencea momentary
increase in their perceived stimulation, which has been described by some patients as
uncomfortable or jolting. It is recommended that patients use caution when
approachingsuchadeviceandthattheyrequestassistancetobypassthedevice.Ifthey
must proceed through the device, patients should turn off the NS and proceed with
caution,beingsuretomovethroughthedetectorquickly.
• Restricted Areas – The patient should be warned to seek medical guidance before
entering environments which could adversely affect the operation of the implanted
device,includingareasprotectedbyawarningnoticepreventingentrybypatientsfitted
withapacemaker.
• ElectromagneticInterference(EMI)–Certaincommercialequipmentsuchasresistance
weldersand induction furnaces,certain communication equipment such as microwave
transmitters, linear power amplifiers, and high voltage power lines may generate
sufficient EMI to interfere with the INS and TNS System resulting in understimulation,
overstimulation, or difficulty in device communications.Certain medical devices may
also cause EMI interference andmake it difficult to communicatewiththe INS
or TNS;
such devices include bone growth stimulators, transcutaneous electrical nerve
stimulation(TENS),andimplantedcardiacdevices.
• LeadMovement–Thepatientshouldbeinstructedtoavoidexcessivebending,twisting,
andstretching,enteringhyperbaricchambersabove2.0atmosphere,andoperatingthe
neurostimulator while driving or lifting objects of over 2Kg (5 lbs) for aminimum of 6
weeksafterimplantation. These activitiesmaycause lead movement, whichcanresult
in understimulation or overstimulation for the patient.Excessive lead migration may
leadtotheneedforreoperationtoreplacetheleads.