Advanced Neuromodulation Systems Inc. dba. St. Jude Medical Neuromodulation Division 001 Manuel D’Utilisation

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Genesis Programmer User’s Guide
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implanted with non-adjacent multiple leads and/or patients that are sensitive to low stimulation
thresholds may experience a momentary increase in their perceived stimulation, which has been
described by some patients as uncomfortable or jolting. It is recommended that patients use caution
when approaching such a device and 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 detector quickly.
Lead Movement — Avoid bending, twisting, stretching, or lifting objects over five pounds, for six
to eight weeks post-implantation. Extension of the upper torso or neck may cause lead movement
and alter the stimulation field (especially with leads in the cervical area), resulting in
overstimulation or ineffective stimulation.
Explosive or Flammable Gases — Do not use the programmer in an environment where explosive
or flammable gasses are present.
Cardiac Pacemakers — Implanted neurostimulation systems may adversely affect the operation of
implanted cardiac demand pacemakers.
Pediatric Use — Safety and effectiveness of spinal cord stimulation has not been established for
pediatric use.
Pregnancy — Safety for use during pregnancy has not been established.
Cardioverter Defibrillators — Neurostimulation systems may adversely affect the programming
of implanted cardioverter defibrillators.
Postural Changes — Changes in posture or abrupt movements can change the level of stimulation
and potentially cause unpleasant sensations. Turn your IPG off or lower the amplitude before
stretching, lifting your arms over your head, or exercising. If unpleasant sensations occur, the IPG
should be turned off.
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RECAUTIONS
This section lists the actions you should be aware of and avoid to prevent situations that may
cause uncomfortable sensations or damage to your neurostimulation system.
Keep the Programmer Dry — Do not use the programmer when engaging in activities that might
cause the programmer to get wet, such as exposure to rain, swimming, bathing, etc. Your
programmer is not waterproof and should be kept dry to avoid damage.
Handle the Programmer With Care — The programmer is a sensitive electronic device that can
be damaged by rough handling, including dropping on the ground or being crushed.
Battery Care — Batteries can explode, leak or melt if disassembled, shorted (when battery
connections contact metal), or exposed to high temperature or fire.
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