Boston Scientific Vercise Mode D'emploi page 9

• 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.
• For DBS devices not using Bluetooth technology for communication, 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.
• For DBS devices using Bluetooth technology for communication, other sources of
electromagnetic disturbance, such as Wi‑Fi routers, cordless phones, Bluetooth wireless
streaming devices, baby monitors, and microwave ovens.
Note: When in close proximity to them, 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.
Heat Due to Charging: Patients should not charge while sleeping. This may result in a burn.
The Charger may become warm while charging the Stimulator. The Charger should be handled
with care. Failure to use the Charging Collar, Charging Belt, or an Adhesive Patch while charging,
as directed, may result in a burn. If the patient experiences pain or discomfort, they should stop
charging and contact their healthcare provider.
Intracranial Hemorrhage: Special precautions should be taken for patients who are prone
to hemorrhage, including patients with coagulopathy, high blood pressure, or those who are using
prescribed anticoagulants. Microelectrode penetration and DBS Lead insertion can put patients
who have a likelihood of intracranial hemorrhages at greater risk.
Magnetic Resonance Imaging (MRI): The Vercise Genus and Vercise Gevia
DBS Systems are "MR Conditional." This means that an MRI examination can be conducted safely
using a 1.5 Tesla horizontal closed bore MRI system when all instructions and safety information in
the supplemental manual ImageReady™ MRI Guidelines for Boston Scientific DBS Systems are
followed.
The ImageReady™ MRI Guidelines for Boston Scientific DBS Systems manual appears on the
Boston Scientific website www.bostonscientific.com/manuals or may be provided in your region. It
is important to read the information in this supplemental manual in its entirety before conducting or
recommending an MRI examination on a patient with a Boston Scientific DBS System.
External Devices: The external/non‑implantable components of the Boston Scientific DBS System
(External Trial Stimulator, ETS Adapter, OR Cables, Remote Control, Charging System,
Clinician Programmer, and accessories) are MR Unsafe. They must not be taken into any MR
environment such as the MRI scanner room.
Other Active Implantable Devices: Concurrent use of Stimulators such as the
Boston Scientific DBS Stimulator and other active implantable devices, such as pacemakers,
cardioverter defibrillators, or medication delivery pumps may result in interference with the
operation of the devices. If the patient requires concomitant implantable active devices, careful
programming of each system is necessary.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Safety Information
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