Product Info

Vercise™ Deep Brain Stimulation Systems Information for Prescribers

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Precautions

Physician training is required for usage of the Boston Scientic 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.

Cell Phones: 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 to avoid placing

cell phones directly over the implanted Stimulator. If interference does occur, move the cell phone

away from the implanted Stimulator or turn off the cell phone.

Cleaning the Charging Belt or Charging Collar: Do not machine wash the Charging

Belt or Charging Collar.

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.

Component Removal, Disposal, and Return: Any explanted components should be

returned to Boston Scientic. The Stimulator should be explanted in the case of cremation and

returned to Boston Scientic. Cremation may cause the Stimulator battery to explode.

The Remote Control or Charger should not be disposed of in re, as these devices contain

batteries which may explode causing injury when exposed to re. 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 Scientic and intended for use with the Boston Scientic DBS System may damage the

DBS System, diminish the effectiveness of therapy, and/or put the patient at unknown risk.

Connections: Before inserting any DBS Lead or DBS Lead Extension into any Connector

or Header ports, including the Stimulator Header, DBS Lead Extension Connectors, and

OR Cable Assembly, always wipe the DBS Lead with a sterile, dry cotton sponge. Contamination

inside the Connector or Header ports may be difcult to remove and can cause high impedances,

preventing electrical connectivity which may compromise the integrity of the stimulation circuit.