Operating Instructions

8
Remote Controller considerably (for example, do not leave the Remote Controller in your 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 your
Remote Controller.
Scuba Diving or Hyperbaric Chambers
Yes, you can enjoy swimming and diving with your Microstimulator. However, you 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, discuss the effects of high pressure with your doctor. And, remember to leave your Remote
Controller in a dry place—do not use the Remote Controller while swimming or diving.
Excess Pressure or Trauma
You can enjoy a wide variety of sports with your Microstimulator. However, you should avoid putting
excess pressure on your Microstimulator and avoid trauma to that area. Playing certain contact
sports (for example, boxing) may damage your System or change how well it works with your
headaches. If you experience excess pressure or trauma to the area around your Microstimulator,
contact your doctor.
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
22.
7. RISKS AND SIDE EFFECTS
Please discuss the risks and benefits with your doctor to determine if the device is right for you. Risks
of neurostimulation therapy can include surgical risks, possible side effects, or device complications.
Your doctor can provide more information about these and other potential risks. Please follow your
doctor’s instructions after surgery to minimize surgical risk.
Similar to other oral procedures, most patients will experience some or all of the following effects
post-surgery and most effects resolve within 60 days:
• Sensory and/or motor dysfunction, including numbness, other sensations, and/or facial paresis
(slight or incomplete paralysis)
• Post-operative pain, swelling and/or tenderness at the surgery site
Other risks of surgery may include:
• Seroma/Hematoma (a collection of serum/blood in the body)
• Abcess
• Bruising
• Permanent numbness and other sensations
• Dry eye and tearing