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Radiofrequency (RF) ablation
– Safety has not been established for
radiofrequency (RF) ablation in patients with a Stimulator. RF ablation may
cause induced electrical currents that result in heating and tissue damage. Do
not use RF ablation anywhere near the Stimulator. If RF ablation is used, ensure
that ablation is not performed over or near the Stimulator.
Electrocautery
– If electrocautery tools are used near the Stimulator then the
insulation can be damaged. The Stimulator may fail or conduct induced
currents. Induced electrical currents can cause heating that results in tissue
damage.
When electrocautery is necessary, these precautions must be followed:
•
The WAA Programmer should be taken off.
•
Bipolar cautery should be used.
•
If unipolar cautery is necessary:
o
Only low-voltage modes should be used.
o
The lowest possible power setting should be used.
o
The current path (ground plate) should be kept as far away as
possible from the Stimulator.
o
Full-length operating room table ground pads should not be used.
•
After electrocautery, confirm that the Stimulator is working as
intended.
Electrostatic Discharge (ESD) –
Testing indicates the WAA can be susceptible to
damage resulting from ESD greater than +/-6kV that can occur in certain
environments, such as home use, when the relative humidity is below 30%.
Freedom users and caregivers should avoid approaching or touching the WAA
in these situations and avoid contact with highly charged conductors,
particularly synthetic materials (e.g., nylon, polyester) during periods of low
relative humidity (less than 30%). ESD might result in temporary or permanent
loss of function. If ESD with the WAA is observed, remove the device from your
body and power off then power on the device. Confirm the device
indicators/lights are operating correctly before resuming therapy. If the device
will not power on, your stimulation therapy will not be delivered and you
should contact Stimwave for assistance or replacement.
High-output ultrasonics / lithotripsy
– Safety has not been established for
high-output ultrasonics or lithotripsy when implanted with the Freedom SCS
System. Use of lithotripsy may result in damage to the device or harm to the
patient.
