Operating Instructions

5
5. PULSANTE® SPG MICROSTIMULATOR SYSTEM CONTRAINDICATIONS
The Pulsante® SPG Microstimulator System should not be used in patients who have an opening to
the pterygopalatine fossa of less than 1.2mm or have had metal implants or facial surgery in an area
that would prevent proper placement of the Microstimulator.
6. WARNINGS & PRECAUTIONS
WARNINGS
Carefully read all instructions prior to use. Observe all warnings and precautions noted in this Manual.
Diathermy
Diathermy is the use of high-frequency electromagnetic currents as a form of physical therapy in
surgical procedures. Do Not undergo shortwave diathermy, microwave diathermy, or therapeutic
diathermy. Diathermy may cause damage to the tissue near your Microstimulator.
Magnetic Resonance Imaging (MRI)
Because a number of things affect MRI compatibility, your safety and the effectiveness of your
therapy after your Microstimulator has been exposed to MRI is unknown. MRI uses strong energy
that may interact with your Microstimulator and injure tissue near your Microstimulator. You should
not undergo MRI until you have talked with your doctor.
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.
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 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