Responsive Neurostimulator System 11
RNS
®
System User Manual
Electromagnetic interference is a field of energy generated by equipment found in the
home, work, medical, or public environments that is strong enough to interfere with
neurostimulator function. Sources of strong electromagnetic interference can result in
the following effects:
• Serious patient injury or death - It is possible for the interference sources to
couple enough energy into a neurostimulator system to damage brain tissue
• System damage - resulting in a loss or change in symptom control and requiring
reoperation
• Operational changes to the neurostimulator - causing stimulation to turn on or
off, or resetting or reprogramming the neurostimulator resulting in a return of
symptoms
• Unexpected changes in stimulation - causing a momentary increase in
stimulation which may be felt by the patient
Patients should exercise caution in avoidance of devices which generate a strong
electric or magnetic field. Refer to Electromagnetic Emissions and Immunity for
more information.
WARNING: R
ADIO FREQUENCY IDENTIFICATION (RFID) INTERFERENCE
Sources of RFID can result in signals that appear as ECoG activity to the
neurostimulator. Signals that appear as ECoG activity could also result in delivering
the programmed stimulation to the patient (per the device detection programming).
The physician should be aware of possible sensing artifacts when assessing the
ECoG recordings. Potential sources of RFID may occur in a health care environment,
retail stores, public libraries, airports and business environments.
Refer to Electromagnetic Emissions and Immunity for more information.
WARNING: S
ECURITY AND ELECTRONIC TRACKING SYSTEMS
Security screening devices (such as theft detectors and airport security screening
devices) can result in signals that appear as ECoG activity to the neurostimulator.
Signals that appear as ECoG activity could also result in delivering the programmed
stimulation to the patient (per the device detection programming). Such devices may
be found at retail stores, public libraries and airports. The physician should be aware
of possible sensing artifacts when assessing the ECoG recordings. Patients should be
instructed to walk through the center of such security screening units without stopping,
when possible, and exit the area of the screening device as soon as possible.
Refer to Electromagnetic Emissions and Immunity for more information.
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