Boston Scientific Vercise Gevia Instrucciones De Uso página 7

External Devices: Boston Scientific external components (i.e., External Trial Stimulator, ETS
Adapter, and OR Cables, Remote Control and accessories, Battery Charger, Clinician Programmer)
are MR Unsafe. They must not be taken into any MR environment such as the MRI scanner.
Electromagnetic Interference. Strong electromagnetic fields can potentially turn the
Stimulator off, cause temporary unpredictable changes in stimulation, or interfere with the Remote
Control communication. Patients should be counseled to avoid or exercise care around the
following:
• Theft detectors and tag deactivators, such as those used at department stores, libraries,
and other public establishments. The patient should proceed with caution, ensuring to
move through the center of the detector as quickly as possible.
• Security screeners, such as those used in Airport Security or at entrances to government
buildings, including hand-held scanners. The patient should request assistance to
bypass the device. If the patient must pass through the security screener, they should
move quickly through the device staying as far from the physical device as allowable.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft
systems that can broadcast a radio frequency (RF) signal. The high energy fields
produced by these systems may interfere with the operation of the Remote Control and
its ability to control stimulation.
• Other sources of electromagnetic disturbance, such as RF transmitters at television or
radio broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family
Radio Service band transceivers.
Note: When in close proximity, equipment that generates strong electromagnetic fields might
cause unintended stimulation or interfere with wireless communication even if they comply
with International Special Committee on Radio Interference (CISPR) requirements.
DBS Extension Connector and Stimulator Placement. Implanting the DBS
Extension connector in the soft tissue of the neck may increase the chance of DBS Lead breakage.
Boston Scientific recommends placing the DBS Extension connector behind the ear such that
glasses or headgear do not interfere with the system. Boston Scientific recommends that the
Stimulator be placed subclavicularly.
Heat Due to Charging. The Charger may become warm while charging the stimulator. The
Charger should be handled with care. Failure to use either the Charging Collar or an Adhesive
Patch while charging, as directed, may result in a burn. The Patient should not charge while
sleeping. This may result in a burn. If the patient experiences pain or discomfort, they should cease
charging and contact their physician.
Stimulator Damage. Chemical burns may result if the Stimulator housing is ruptured or
pierced, exposing the patient's tissue to battery chemicals. Do not implant the Stimulator if the
housing is damaged.
Safety Information
Vercise Gevia™ Information for Prescribers
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