Programming Manual

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using the Surgical Introducer (SI‑100 or SI‑110) as a guide. Remove the Surgical Introducers leaving
the lead in the fossa. Anchor the Microstimulator Body to the anterior zygomatic process of the
maxilla using the Bone Fixation Plate and at least two bone screws.
NOTE: Bone screws are not supplied by Autonomic Technologies.
7. 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.
8. WARNINGS & PRECAUTIONS
WARNINGS
Carefully read all instructions prior to use. Observe all warnings and precautions noted in this Manual.
Implantation
Only physicians with sufficient skill and expertise in the surgical anatomy of the midface, anterior skull
base, pterygopalatine fossa and infratemporal fossa should perform this procedure. Additionally, only
physicians with sufficient skill and expertise in trans-oral surgical techniques, including proper sterile
techniques, should perform this procedure. The surgery is performed under anesthesia, which has its
accompanying risks. Infection may result from the implantation procedure or the implanted device.
Use only specified Pulsante® devices and accessories, specifically the Microstimulator, Remote
Controller, Charger, Surgical Tools and Programmer Software.
Electrostatic Discharge
The integral Microstimulator lead electrodes provide a low-impedance pathway to the Microstimulator
electronics. It is recommended that all healthcare personnel handling the Microstimulator avoid
directly touching the electrodes. Placing the Microstimulator within physiologic saline (only), as
described in the Implant Procedure section, is recommended before handling the Microstimulator.
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. Patients should be
advised to contact their doctor before undergoing diathermy.
Magnetic Resonance Imaging (MRI)
The Pulsante® System is MRI Unsafe. Patients should be advised to contact their doctor before
undergoing MRI.
Chronic SPG Stimulation
The effects of chronic SPG stimulation on peripheral nerve structures are not known. In addition, the
effect of chronic SPG stimulation on cognitive function is not known. Patients should be advised to
contact their doctor if they experience any unusual symptoms that they think may be related to the
Microstimulator. If you decide that the System is not providing the therapy needed, it may be left
implanted and not used for stimulation or will require additional surgery to be explanted.