User's Manual

 The patient should not allow unauthorized use of your Patient Programmer. This may cause un-
wanted 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 dur-
ing 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 personnel 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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