Precautions - Boston Scientific Vercise Mode D'emploi

Precautions

Physician training is required for usage of the Boston Scientific DBS System. The implanting
physician should be experienced in the subspecialty of Stereotactic and Functional Neurosurgery.
The following is a list of precautions that should be taken when implanting or using the DBS
Stimulator.
Bathing: Patients should exercise reasonable caution when bathing.
Cell Phones and Other Portable RF Communication Devices: While interference
caused by cell phones is not anticipated, the full effects of interaction with cell phones are unknown
at this time. Patients should be instructed that portable RF communications equipment (for
example, mobile phones) should be kept a minimum distance of 6 inches (15 cm) from the area
of the implanted device. If interference does occur, move the cell phone away from the implanted
Stimulator or turn off the phone. If there is a concern or a problem is encountered, patients should
contact their healthcare provider.
Cleaning the Remote Control, External Trial Stimulator, Charger,
Base Station, Power Supply, and Programming Wand: Do not use abrasive
cleansers for cleaning. Do not clean any of the accessories while they are directly or indirectly
connected to a power outlet.
As an operator of the external devices, perform only the following maintenance tasks on the
external devices:
• Changing the battery
• Charging the battery
• Cleaning
Ensure that the devices are not in use while performing service and maintenance tasks.
Cleaning the Charging Belt or Charging Collar: Do not machine wash the Charging
Belt or Charging Collar.
Component Removal, Disposal, and Return: Any explanted components should be
returned to Boston Scientific. The Stimulator should be explanted in the case of cremation and
returned to Boston Scientific. Cremation may cause the Stimulator battery to explode.
The Remote Control or Charger should not be disposed of in fire, as these devices contain
batteries which may explode causing injury when exposed to fire. Used batteries should be
disposed of in accordance with local laws and regulations.
Dispose of non‑implantable components and packaging in accordance with hospital, administrative,
and/or local government policy.
Components: The use of components other than those approved and/or supplied by
Boston Scientific and intended for use with the Boston Scientific DBS System may damage the
DBS System, diminish the effectiveness of therapy, and/or put the patient at unknown risk.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Safety Information
92328649-04 7 of 149