St. Jude Medical Axium, Руководство пользователя

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• Activities Related to Lead Movement - Limit your activities to low or moderate
levels during your trial stimulation period and the first six weeks of implantation
of the INS. Failure to do so may result in migration of the leads causing loss of
stimulation therapy, muscle stimulation or painful stimulation thereby requiring
reoperation to reposition. You may turn off your device if stimulation becomes
uncomfortable.
◦ Do not rub or press on the implant site. This may cause the leads to move or
your skin to erode. It may also cause the INS to move.
◦ Avoid excessive bending, twisting and stretching. Do not lift objects over five
pounds. These activities may cause the leads to move. You may experience
higher or lower levels of stimulation.
• Theft Detectors and Metal Screening Devices – Certain types of antitheft
devices, such as those used at entrances/exits of department stores, libraries,
and other public establishments, and/or airport security screening devices
may affect stimulation. If you have implanted non-adjacent multiple leads or
are sensitive to low stimulation thresholds you may experience a momentary
increase in perceived stimulation, which has been described as uncomfortable
or jolting. Use caution when approaching such a device and request assistance
to bypass the device. If you must proceed through the device, turn off the NS
and proceed with caution, being sure to move through the detector quickly.
• Restricted Areas – Seek medical guidance before entering environments
which could adversely affect the operation of the implanted device, including
areas protected by a warning notice preventing entry by patients fitted with a
pacemaker.
• Scuba Diving and Hyperbaric Chambers –
Avoid scuba diving and entering
hyperbaric chambers above 150 kPa. These activities may damage the Axium
system.
• Cell Phones - While interference with cell phones is not anticipated, cell phone
technology continues to change, and interaction with a neurostimulator system
is possible. Contact your physician if you have a concern about cell phone
interaction with your neurostimulator system.
• Electromagnetic Interference (EMI) – Electromagnetic interference is a
field of energy generated by equipment found in the home, work, medical or
public environments that is strong enough to interfere with neurostimulator
function. Most electrical devices and magnets encountered in a normal day are
unlikely to affect the operation of a neurostimulator. Keep away from areas of
EMI and turn off the stimulator if they are in such an area. Sources of strong
electromagnetic interference can result in the following:
◦ Operational changes – Operational changes to the neurostimulator, causing it
to turn on or off (particularly in neurostimulators enabled for magnet use), or to
reset to power-on- reset (POR) settings, resulting in loss of stimulation, return
of symptoms, and in the case of POR, requiring reprogramming by a clinician.
◦ Unexpected changes in stimulation , causing a momentary increase in
stimulation or intermittent stimulation, which some patients have described as
a jolting or shocking sensation. Although the unexpected change in stimulation
may feel uncomfortable, it does not damage the device or injure you directly. In