User's Manual

• The patient should not try to replace the TNS device battery, even if the TNS device does not function. The
internal battery for the TNS device must be replaced by Spinal Modulation personnel only.
• The NS device can only be programmed using Spinal Modulation’s Patient Programmer. The patient should
not attempt to use any other manufacturer’s device to program it.
• The patient should not allow unauthorized use of your Patient Programmer. This may cause unwanted
changes in the programming.
• The patient should not use the Patient Programmer or NS in the presence of explosive or flammable gases as
this may cause serious injury.
The patient should be instructed to take the following precautions to maintain appropriate therapy during this study:
• Follow proper wound care techniques as instructed by their doctor.
• Do not rub or exert pressure at the implant site as it may dislodge the leads or cause skin erosion.
• Avoid excessive bending, twisting and stretching, and do not lift objects over ten pounds. These activities may
result in lead movement producing either understimulation or overstimulation.
• Avoid driving a car or operating other potentially dangerous machinery while stimulation is turned on. If
sudden changes in stimulation were to occur, the patient may be distracted from vehicle or device operation.
• It is possible that the NS System may affect the operation of other implantable devices such as pacemakers or
implantable cardiac defibrillators. The physician should be aware of any other implantable devices the patient
may have or are scheduled to get.
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PRECAUTIONS –THERAPY
• The patient’s other healthcare providers should be aware of their NS. They should not undergo any elective
medical procedures during the trial stimulation period. Some medical devices or therapies, such as those
listed below, may produce interference with the TNS System:
• Electrocautery – Electric probe: to cauterize blood vessels and stop bleeding during surgery.
• Lithotripsy – High-output shock waves: breaks up gallstones and kidney stones.
• Therapeutic Radiation – Ionizing radiation: to destroy cancer cells.
• High-output ultrasound – High frequency sound waves: to treat bone and muscle injuries, or to
stimulate muscle or improve blood flow.
• RF Ablation – Radio frequency energy: causes controlled tissue damage.
• Microwave Ablation – High speed alternating electric field: causes controlled tissue damage.
• Dental procedures, electrolysis, static field therapeutic magnets and diagnostic X-ray.
• The patient should designate a representative (family member or friend) to notify emergency medical per-
sonnel of their trial stimulator, in case they require emergency care. The patient will be provided with a
Medical Alert Card to carry with them that will inform emergency medical personnel that they have an NS.
If there is any concern regarding the proper function of the NS System, they should discontinue use and contact
their physician during normal business hours.
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