Boston Scientific Vercise PC Instrucciones De Uso página 7

Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used
on patients implanted with the Vercise PC DBS System, or any of the system components. The
Stimulator, whether it is turned on or off, may be critically damaged by the use of diathermy. The
energy generated by diathermy can be transferred to the Vercise PC DBS System, causing tissue
damage at the contact site resulting in severe injury or death.
Magnetic Resonance Imaging. Patients implanted with the Vercise PC DBS System,
or any of its components, should not be subjected to Magnetic Resonance Imaging (MRI). MRI
exposure may result in the following:
• Dislodgement of implanted components
• Heating of the contacts, or other system components, causing permanent tissue
lesioning
• Damage to the Stimulator's electronics
• Current induction through the DBS Leads and Vercise PC DBS System components
causing unpredictable levels of stimulation
• Distortion of the diagnostic image
• Personal injury or even death
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 such as those used at entrances/exits of 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 interference, such as RF transmitters at television or
radio broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family
Radio Service band transceivers.
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.
Safety Information
Vercise™ PC Information for Prescribers
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