User's Manual

 The patient must not undergo any diathermy (high energy heat) procedures. Diathermy could
injure the patient or damage the NS device.
 The patient must not remove the lead(s) or Connector Cable from their body. Removal of the lead
(s) or Connector Cable may result in an infection.
 Changes in body position can affect the amount of stimulation felt, causing increased feelings of
pain or uncomfortable stimulation. The patient should use the Patient Programmer to adjust stimu-
lation levels or to turn stimulation off, if needed.
 Under certain conditions, strong electromagnetic fields may affect the NS device, possibly affecting
the level of stimulation and causing discomfort. The patient should avoid theft detection devices at
store and library exits and security screeners at airports. The patient must not stand near the screen-
ing equipment.
 Other equipment that may cause interference includes, but is not limited to: power generators, arc
welders and large magnetized speakers
The following precautions should be taken to avoid damage to and assure proper function of the Patient
Programmer and TNS device.
 The patient should not drop or mishandle the Patient Programmer or TNS device. Physical damage
to the units may impair their function.
 The patient should not wash or get the Patient Programmer or TNS device wet.
 The patient should not shower or bathe with the TNS device. (A sponge bath is acceptable as long
as the TNS device does not get wet.).
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PRECAUTIONS —DEVICES
 The patient should not use abrasive or caustic cleaning products on the Patient Programmer or TNS
device.
 The patient should not open the cases of the Patient Programmer or TNS device. Attempts to open
the cases may expose the units to elements that alter their function.
 The patient should not place the Patient Programmer close to credit cards or other cards with mag-
netic strips, as the Patient Programmer contains a magnet and may demagnetize your cards. Also, the
patient should keep the Patient Programmer away from computer hard drives or magnetic storage
devices.
 The patient should not operate the Patient Programmer or TNS device outside the temperature range
of -5°C to 45°C. Rapid temperature changes may affect device operation.
 The patient should not store the Patient Programmer outside the temperature range of -10°C to
50°C.
 The patient should not leave the Patient Programmer in a car or other places where temperatures can
exceed 50°C.
 Failure of your NS System, although unlikely, is possible due to random component failure. If any
part of the TNS System stops working, contact your doctor during normal business hours.
 The Patient Programmer and the TNS device must be returned at the end of the trial period. The
patient must not discard or burn the TNS device or Patient Programmer. Fire may cause its internal
battery to explode.
 The patient should not try to replace the TNS device battery, even if the TNS device does not func-
tion. The internal battery for the TNS device must be replaced by Spinal Modulation personnel only.
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