Operating Instructions

7
Post-Implant Medical Tests and Procedures
Before you undergo any medical tests or procedures, you should contact your doctor to determine if
the procedure will cause damage to your System. The following procedures or tests should only be
performed and the following devices should only be used after talking to your doctor: facial nerve
blocks (for example, infra-orbital or maxillary), orthodontic or dental procedures, and cosmetic
procedures.
Therapeutic Radiation
Therapeutic radiation may damage the electronic circuitry of the System. Sources of therapeutic
radiation include, but are not limited to: therapeutic x-rays, cobalt machines, and linear accelerators. If
radiation therapy is required, the area over the implanted device should be shielded with lead.
Implantable and External Devices
How your System works with other medical devices, including pacemakers, defibrillators,
neurostimulators, hearing aids and other implantable and external devices, is not well understood. If
you require such a device, your doctor should consult Autonomic Technologies for current information
concerning the use of these devices.
Cardiac Defibrillation/Cardioversion
The effect of internal or external defibrillation or cardioversion on your implanted Microstimulator is
not known. If you undergo defibrillation, see your doctor to confirm your Microstimulator settings
before using your Remote Controller.
Electromagnetic Interference (EMI)
If you approach certain commercial electrical equipment (for example, arc welders, induction
furnaces, resistance welders), communication equipment (for example, microwave programmers,
linear induction motors, linear power amplifiers, high-power amateur transmitters, and cellular
phones), and high-voltage power lines too closely, it may generate sufficient EMI to cause
paresthesia (a sensation of tingling, pricking or numbness in the face) or interfere with your System. If
you are uncomfortable or unable to apply therapy when you are near such equipment, move away
from the area of EMI. The system has been designed to fail safely so strong EMI could prompt your
Remote Controller to turn off.
Interaction with Electronic Systems
How your System interacts with other electronic devices including RFID systems (particularly within
the 121 kHz to 130 kHz range) is not fully understood. Do not use your remote controller close to
other electronic devices, particularly keyless entry FOBs or near automobile electronics. The strong
electromagnetic fields from the remote controller can disrupt electronic systems that are close by.
Interaction with Metallic or Magnetic Objects
Using the System close to metal or magnetic objects (for example, heavy metal jewelry, metal
headphones, magnetic earrings) may prevent your Remote Controller from communicating properly
with your Microstimulator, especially if that metal object is between your Remote Controller and your
cheek. If you are unable to apply therapy when you are near such objects, move away from the object
and try again. Metallic objects in the mouth (for example, a metal retainer) may get warm if they are
not removed prior to applying therapy. For clarification, your Remote Controller is safe to use with
tooth fillings.
Handling of the Pulsante® Remote Controller
Use care when handling your Remote Controller. The Remote Controller is a sensitive electronic
device that may be damaged by rough handling, including dropping on the ground or being crushed.
Store the Remote Controller in a cool, dry place. Excess heat can reduce the battery life of the