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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.
When possible, it is best to avoid RFID emitters or remove the WAA while
passing near RFID emitters. Patients with an implanted device should inform
the attendant who may be able to assist them in bypassing any RFID emitter. If
unavoidable, the patient should walk through the RFID emitter and promptly
move away from the area. Patients should not lean on scanners or linger in the
area of RFID emitters.
Computed Tomography (CT) Scanning –
Safety has not been established for CT
scanning of patients with a Stimulator. X-rays from the scan could cause
unintended shocks or malfunctions of the Stimulator.
The CT operator should use CT scout views to determine if implanted medical
devices are present and their location relative to the programmed scan range.
For CT procedures in which the device is in or immediately adjacent to the
programmed scan range, the operator should:
•
Remove the WAA Programmer from the CT scan range.
•
Minimize X-ray exposure to the implanted device by:
o
Using the lowest possible X-ray tube current consistent with
obtaining the required image quality.
o
Making sure that the X-ray beam does not dwell over the
Stimulator for more than a few seconds.