Postural Changes. Patients should be
advised that changes in posture or abrupt
movements may cause decreases, or
uncomfortable or painful increases in the
perceived stimulation level. Patients should
be advised to turn down the amplitude or turn
off the IPG before making posture changes. If
unpleasant sensations occur, the IPG should
be turned off immediately.
Electromagnetic Interference. Strong
electromagnetic fields can potentially turn
the Stimulator off, or cause uncomfortable
or jolting stimulation. Patients should be
counseled to avoid or exercise care around:
• Theft detectors or security screeners
such as those used at entrances/exits
of department stores, libraries, and
other public establishments, and/or
airport security screening devices. It
is recommended thatpatients request
assistance to bypass the device.
If they must proceed through the
device, the patient should turn off the
Stimulator and proceed with caution,
ensuring to move through the center
of the screener as quickly as possible.
• Power lines or power generators
• Electric steel furnaces and arc
welders
• Large, magnetized stereo speakers
Precautions
Physician training is required.
Medical Devices/Therapies. The following
medical therapies or procedures may turn
stimulation off or may cause permanent
damage to the Stimulator, particularly if used
in close proximity to the device:
• lithotripsy
• electrocautery: Do not use monopolar
cautery. See "Instructions for the
Physician" on page 12
• external defibrillation
• radiation therapy
• ultrasonic scanning
• high-output ultrasound
If any of the above is required by medical
necessity, refer to "Instructions for the
Physician" on page 12 . Ultimately,
however, the device may require explantation
as a result of damage to the device.
Automobiles and Other Equipment.
Patients should not operate automobiles,
other motorized vehicles, or potentially
dangerous machinery/ equipment with
therapeutic stimulation switched on.
Stimulation must be turned off first. Sudden
stimulation changes, if they occur, may
distract patients from attentive operation of
the vehicle or equipment.
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Safety Information
Clinician Manual