User's Manual
SpinalModulation,Inc. PhysicianImplantManual
16
• Therapeutic Radiation – Therapeutic radiation may damage the electronic circuitry of
animplantedneurostimulationsystem,althoughnotestinghasbeenperformedandno
definite information on radiation effects is available.Sources of therapeutic radiation
includex‐rays,cobaltmachines,andlinearaccelerators.
Ifradiationtherapyisrequired,
theareaovertheimplantedINSshouldbeshieldedwithlead.
Precautions
ThefollowingprecautionsapplytotheuseoftheAxium™NeurostimulatorSystem:
• Physician Training – Implanting physicians should be experienced in the diagnosis and
treatment of chronic pain syndromes and have undergone surgical and device
implantationtraining.
• Patient Selection – It is extremely important to select patients appropriately for
neurostimulation and that thorough psychiatric screening be performed. Patients
should not be dependent on drugs and should be able to operate the spinal cord
stimulatorsystem.
• Infection – It is important to follow proper infection control procedures.Infections
relatedtosystemimplantationmightrequirethatthedevicebeexplanted.
• ImplantationofTwoSystems–Iftwosystemsareimplanted,ensurethatatleast15cm
(6 in) separates the implanted INSs to minimize the possibility of interference during
programming.
• Implantationof MultipleLeads – If multiple leadsareimplanted, leadsand extensions
shouldberoutedincloseproximity.Nonadjacentleadscanpossiblycreateaconduitfor
strayelectromagneticenergythatcouldcausethepatientunwantedstimulation.
• High Stimulation Outputs – Stimulation at high outputs may cause unpleasant
sensationsormotordisturbancesormayrenderthepatientincapableofcontrollingthe
patient programmer.If unpleasant sensations occur, the device
should be turned off
immediately.
• Stimulation Parameters – Patients should be cautioned that stimulation parameters
must be determined under the supervision of a physician and that they should not
adjuststimulationparameterswithinprescribedprogramsunlessorderedtodosobya
physician.
• Cellular Phones – The effect of
cellular phones on neurostimulation systems is
unknown;patientsshouldavoidplacingcellularphonesdirectlyoverthesystem.
• Trial Leads – Trial Leads are intended for use for up to 30 days.Use of these devices
mustbeperformedinaccordancewiththeinstructionsprovidedinthismanual.
• Overprogramming
– Excessive communication with the device can shorten the life of
the INS.The patient should be warned to communicate with the device only when
necessary.