Operating Instructions

6
of another device. Do not place another device’s transmitter over the Microstimulator. It may
accidentally disrupt the operation of the Microstimulator.
Exposure to Moisture
Do Not use your Remote Controller to activate your Microstimulator while showering, swimming, or
during other activities where the Remote Controller may get wet. The Remote Controller is not
waterproof and should be kept dry to avoid damage.
PRECAUTIONS
Doctor Instructions
Always follow your doctor’s instructions. Failure to do so may cause the therapy to be less effective in
providing headache relief.
Pulsante® SPG Microstimulator System Failure
Although it is unlikely, the System may unexpectedly malfunction, as does any implantable electronic
device. Autonomic Technologies has completed extensive testing under worst-case conditions to
develop and manufacture high-quality devices. However, malfunctions may be caused by things that
cannot be predicted and may result in the device not working and the need for additional surgery. If a
malfunction occurs, then your Remote Controller may not be able to wirelessly connect with your
Microstimulator or your Microstimulator may not deliver therapy.
Lack of Therapy
The communication between the Remote Controller and the Microstimulator is based on many
factors, including orientation and distance between the two devices. Swelling near the incision and/or
implant location may prevent communication between the Remote Controller and the implanted
Microstimulator, and therapy may not be possible. Your doctor will adjust your device settings over
time to optimize therapy based on your anatomy and device placement. If you have any difficulty
getting the Remote Controller to wirelessly connect with the Microstimulator, please consult your
doctor or consult the Troubleshooting section of this manual.
Device Migration
While unlikely, the “lead” of your Microstimulator (the part that contains the electrodes and sits near
your SPG) may move from its desired location. Lead movement may change how well your therapy
works. If lead movement does occur, additional surgery may be needed. To help minimize the chance
of lead migration, care should be taken (particularly in the two weeks after the Microstimulator
surgery) not to put excess pressure on the implant location.
Long-Term Stimulation
The effects of long-term SPG stimulation are not known. If you experience any unusual symptoms
that you think may be related to your Microstimulator, contact your doctor. If you or your doctor decide
that the System is not providing the therapy you need, it may be left implanted and not used for
stimulation or will require additional surgery to be explanted.
Prior Surgical Procedures
Alert your doctor if you have had a previous facial or skull surgery. If any metal objects have been
implanted in your face, these implanted objects may interfere with the System. Prior surgeries in
these areas may also affect the position of the Microstimulator. Tooth fillings will not interfere with the
System.