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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 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.
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.
Psychotherapeutic procedures
–
Safety has not been established for
psychotherapeutic
procedures
using
equipment
that
generates
electromagnetic interference (e.g., electroconvulsive therapy, transcranial
magnetic stimulation) in patients who have spinal cord stimulators. Induced
electrical currents can cause heating that may result in tissue damage.
Radiofrequency Identification (RFID) Emitters - Theft detectors, electronic
article surveillance (EAS) systems, and radiofrequency identification systems
–
Tests have been performed with an array of simulated RFID emitter systems,
and have demonstrated that the Freedom SCS System (implanted device and
WAA) can be affected by separation distances between the Freedom SCS
System and the RFID emitter of less than 3m (~10 ft.). More powerful RFID
Emitters might cause effect at farther distances. RFID emitters can be hidden or
portable and not obvious to the Stimwave user. Any RFID emitter may
temporarily interrupt stimulation, or cause elevated levels of stimulation. It is
recommended that if a patient feels a change in stimulation near a potential
RFID emitter, they promptly move away from the area and remove the WAA
from the body.
