Responsive Neurostimulator System
17
RNS
®
System User Manual
Precaution: Electronic Interference
Communications between the programmer and the implanted neurostimulator may be
interrupted by emissions from nearby electronic devices. Examples of sources of EMI
are lithotripsy, computer monitors, cellular telephones, motorized wheel chairs, x-ray
equipment and other monitoring equipment. Interruption of telemetry can result in
incomplete communication. If EMI disrupts programming, move the programmer away
from the likely source of EMI. Refer to the
Poor or No Communication Between the
RNS® Neurostimulator and the Programmer
Precaution: Placement of the Programmer Power Cords
Make sure nothing rests on the programmer power cable and that the cable is not
located where it can be tripped over or stepped on.
Precaution: Heating
The programmer AC adapter and the bottom of the laptop computer may become hot
during normal operation. Use care when handling the adapter during or immediately
after operation.
P
RECAUTIONS
–
H
OME OR
O
CCUPATIONAL
Precaution: Keep Magnets at least 4 inches Away from the Implanted RNS
®
Neurostimulator
Magnets that are contained in such products as stereo speakers, AM/FM radios,
power tools, cellular, cordless and conventional phones, as well as magnets used
therapeutically or worn on the body, should be kept at least 4 inches away from the
neurostimulator. The neurostimulator may not deliver stimulation while these magnets
are closer than 4 inches. Most headsets and earphones available in stores do not
interfere with the RNS
®
System, but not all have been tested.
Precaution: Magnet
Use care when handling the magnet as it may break if dropped and the broken pieces
may have sharp edges.
Precaution: Scuba diving or hyperbaric chambers
Patients should not dive below 10 meters (33 feet) of water or enter hyperbaric
chambers above 2.0 atmospheres absolute (ATA). Such pressures could damage the
system.
Precaution: Patient Population for which safety and efficacy have not been established
The safety and effectiveness of the device has not been established for the following:
•
Patients with generalized epilepsy
•
Patients with a seizure focus that cannot be adequately localized
•
Pregnant women
•
Nursing mothers
•
Less than age 18
•
Patients with simple partial sensory seizures only
•
Patients with less than three seizures a month on average
•
Patients who have more than two epileptic foci
•
Patients who have not failed two antiepileptic drugs
Precaution: Safety and Effectiveness beyond 24 months
The safety and effectiveness of the RNS
®
System beyond 24 months is unknown.
