Programming Manual

8
Procedures of the Pterygopalatine Fossa
The SPG is located within a space behind your nose called the pterygopalatine fossa. This is where
part of your Microstimulator is implanted. The effects of other procedures on the Microstimulator in
this area are not known. Permanent damage to the Microstimulator may result from these
procedures. Procedures in this area include intra-nasal thermocoagulation and procedures to the
SPG, maxillary branch of the trigeminal nerve, vidian nerve or other neurovascular structures. NOTE:
Inform your doctor of the implanted Microstimulator before undergoing any procedure in the
pterygopalatine fossa.
Electrocautery / Electrosurgery
The use of electrocautery or electrosurgery may cause damage to the Microstimulator, particularly if
used in close proximity to the Microstimulator electrodes. To ensure proper functionality, interrogate
the Microstimulator and perform an electrode impedance test.
Electrical Therapies and Diagnostic Imaging
The effects of certain electrical therapies and diagnostic imaging on the Microstimulator are not well
understood. If you require such treatment, your doctor should consult Autonomic Technologies for
current information on how electrical therapies and diagnostic imaging could affect your device.
Electrical therapies and diagnostic imaging include, but are not limited to: nuclear imaging (for
example, PET Scans), brachytherapy, therapeutic radiation stereotactic radiosurgery,
electroconvulsive therapy, lithotripsy, therapeutic ultrasound, transcranial magnetic stimulation, bone
growth stimulators, and electrolysis. Do Not use your Remote Controller to apply therapy while
undergoing any electrical therapy or diagnostic imaging procedure.
Explosive or Flammable Gases
Do Not use your Remote Controller in an environment where explosive or flammable gases are
present.
Other Patient-Controlled Medical Devices
Do Not place the Remote Controller over other implantable devices (for example, pacemaker,
defibrillator, another neurostimulator). The Remote Controller may accidentally change the operation
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
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