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Laser procedures
–
Safety has not been established for lasers within the vicinity
of the Freedom SCS System. Use of lasers may result in damage to the device or
harm to the patient.
Radiation therapy
–
Safety has not been established for high radiation sources
such as cobalt 60 or gamma radiation when implanted with the Freedom SCS
System. Use of radiation therapy could cause damage to the device or harm to
the patient.
Transcutaneous electrical nerve stimulation
–
Safety has not been established
for use of transcutaneous electrical nerve stimulation (TENS) when implanted
with the Freedom SCS System. Use of TENS could cause the device to turn off
or intermittent/increased stimulation.
Other medical procedures
–
EMI from the following medical procedures is
unlikely to affect the device:
•
Diagnostic ultrasound (e.g., carotid scan, Doppler studies)
•
Diagnostic x-rays or fluoroscopy
•
Magnetoencephalography (MEG)
•
Positron emission tomography (PET) scans
•
Therapeutic magnets (e.g., magnetic mattresses, blankets, wrist
wraps, elbow wraps)
–
Keep the magnet away from the stimulator
site. Magnetic fields will generally not affect the Stimulator.
WAA Skin Contact
–
Do not place the WAA directly on the skin. Direct skin
contact may cause irritation and/or sensitivity to the materials. The WAA must
be placed overtop a thin layer of clothing at all times.
Painful Stimulation
–
If the patient experiences painful stimulation, the
amplitude on the WAA should be decreased immediately and/or removed from
the patient’s body. Contact your clinician if this continues to occur.
Aircraft Usage
–
Safety has not been established for use of the Freedom SCS
System on aircrafts. Use of the Freedom SCS System on a commercial aircraft
may result in damage to the device or harm to the patient.
