Programming Manual

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power lines may generate sufficient EMI to cause paresthesia (a sensation of tingling, pricking or
numbness in the face) or interfere with the System. If a patient is uncomfortable or unable to apply
therapy when near such equipment, the patient should move away from the area of EMI. The system
has been designed to fail safely so strong EMI could prompt the Remote Controller to turn off.
Interaction with Electronic Systems
How the System interacts with other electronic devices including RFID systems (particularly within the
121 kHz to 130 kHz range) is not fully understood. Patients should not use the 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 the Remote Controller and the
patient’s cheek. If the patient is unable to apply therapy when you are near such objects, have the
patient 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, the 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
Remote Controller considerably (for example, patients should not leave the Remote Controller in a
car or under direct sunlight for long periods of time).
Charging the Pulsante® Remote Controller
Only use the Charger provided in the Remote Controller packaging to charge the Remote Controller.
Use of non-Pulsante® charging equipment to charge the Remote Controller can damage the Remote
Controller.
Scuba Diving or Hyperbaric Chambers
Patients should not dive below 30 meters (98 feet) of water or enter hyperbaric chambers above 4.0
atmospheres absolute (ATA), as greater pressures may damage your Microstimulator. Before diving
or using a hyperbaric chamber, patients should discuss the effects of high pressure with their
physician. Also, patients should leave the Remote Controller in a cool, dry play—they should not use
the Remote Controller while swimming or diving.
Excess Pressure or Trauma
Patients should avoid putting excess pressure on the Microstimulator and avoid trauma to that area.
Playing certain contact sports (for example, boxing) may damage the System or change how well it
works with their headaches. If a patient experiences excess pressure or trauma to the area around
your Microstimulator, they should contact their physician.
Pregnancy
The safety and effectiveness of this therapy have not been established for pregnancy, unborn fetus,
or delivery.
Pediatric
The safety and effectiveness of this therapy have not been established for patients under the age of
18.