User's Manual
SpinalModulation,Inc. PhysicianImplantManual
14
Ifthepatientwith anINSorTNSdeviceissubsequentlygivenanymedicaltreatmentin
which an electrical current is passed through his/her body from an external source,
either the device should first be deactivated, or care should be taken to monitor the
functioningoftheneurostimulatorduringtheinitialstagesoftreatment.
• Diathermy Therapy – Do not use short‐wave diathermy, microwave diathermy, or
therapeutic ultrasound diathermy (all now referred to as diathermy) on patients
implanted with a neurostimulation system. Energy from diathermy can be transferred
throughtheimplantedsystemandcausetissuedamageatthelocationoftheimplanted
electrodes,resultinginsevereinjuryordeath.Diathermyisfurtherprohibitedbecause
itmayalsodamagetheneurostimulationsystemcomponents.Thisdamagecouldresult
in loss of therapy, requiring additional surgery for system implantation and
replacement.Injury or damage can occur
during diathermy treatment whether the
neurostimulation system is turned on or off.All patients are advised to inform their
healthcareprofessionalsthattheyshouldnotbeexposedtodiathermytreatment.
• CardiacPacemakersandImplantableCardiacDefibrillators(ICD)–Itispossiblethatthe
device may affect the operation of
other implantable devices such as pacemakers or
implantable cardiac defibrillators. The physician should be aware of any other
implantabledevicesthepatientmayhaveorisscheduledtoreceive.
• Explosive or Flammable Gases – Do not use the patient programmer or clinical
programmertocommunicatewiththeINSorTNSinanenvironmentwhereexplosiveor
flammable gas fumes or vapors are present.The operation of the programmer could
causethemtoignite,causingsevereburns,injury,ordeath.
• CaseDamage–If the INScaseispiercedorruptured,anexplosioncan occur from the
batterychemicals,whichcanleadtosevereburnsorevendeath.
• Device Components – The use of non Spinal Modulation componentswith the system
mayresultindamagetothesystemandincreasedriskofharmtothepatient.
• ComponentDisposal – Return all explanted Neurostimulators to Spinal Modulation for
safe
disposal.Donot crush, puncture, or burn the Neurostimulator becauseexplosion
orfiremayresult.
• Exposure to Fluids – Exposure of the external TNS or the Connector Cable to water,
bodyfluids,saline,orcleaningagentscancausecorrosionandaffectstimulation.Ifthis
occurs, dry all components thoroughly prior to lead connection.Do not immerse the
externalTNSorConnectorCableinfluids.
• Device Handling ‐ The patient must be instructed to not remove their Trial Lead(s) or
ConnectorCable.Manipulationofthecomponentsmayresultinanundesiredoutcome,
such as the patient developing an infection, getting undesirable stimulation, or
accidentallyturningtheirstimulationoff.Thepatientmustbeinstructedtonotrubor
exertpressureonthe implantable neurostimulator through theskinasthismay cause:
leaddislodgementleadingtostimulationattheimplantsite,deviceinversionleadingto
the inability to communicate with the device, or skin erosion that can lead to another
surgicalprocedureorpossibleinfection.