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W
ARNINGS
Electromagnetic interference (EMI)
–
EMI is a field of energy generated by
equipment found in the home, work, medical or public environments. EMI that
is very strong can interfere with System. The device includes features that
provide protection from EMI. Most electrical device and magnets encountered
in a normal day will not affect the operation of the System. However, strong
sources of EMI could result in the following:
•
Serious patient injury resulting from heating of the implanted device
and damage to surrounding tissue.
•
System damage, resulting in a loss of, or change in, symptom control
and requiring additional surgery.
•
Operational changes to the WAA. This may cause either external
device to turn on, turn off, or to reset to factory settings. If this occurs,
the WAA need to be reprogrammed.
•
Unexpected changes in stimulation, causing a momentary increase in
stimulation or intermittent stimulation. Some patients have described
as a jolting or shocking sensation. Although the unexpected change in
stimulation could feel uncomfortable, it does not damage the device
or cause a patient direct injury. In rare cases, as a result of the
unexpected changes in stimulation, patients have fallen down and
been injured.
If you suspect that your Freedom SCS System is being affected by EMI then you
should:
•
Immediately move away from the equipment or object.
•
Remove the WAA from the vicinity.
Machinery or heavy equipment
–
Machinery and heavy equipment (including
vehicles) should not be operated while using the Freedom SCS System.
Malfunction of the System could result in loss of body control, body function,
or a feeling that could render the patient incapable of controlling the system.
Stimulator fracture
–
If the Stimulator insulation is ruptured or pierced due to
extensive forces, unexpected changes in stimulation could result.
Electromagnetic
equipment/environments
–
Avoidance
of
high
electromagnetic equipment radiators or environments is highly encouraged.
Examples of equipment and/or environments include the following:
•
High-power amateur transmitters/antennas or citizen band (CB) radio
or Ham radio used for private recreation, communication, and wireless
experimentation.
