Warnings - Boston Scientific Vercise Manual De Uso

Warnings

Intracranial Hemorrhage. Special precautions should be taken for patients who
are prone to hemorrhage including patients with coagulopathy, with high blood
pressure, or who are using prescribed anticoagulants. Microelectrode penetration
and DBS Lead insertion can put patients who have a likelihood of intracranial
hemorrhages at greater risk.
Charge Density. High levels of stimulation may damage brain tissue. Whenever
possible, the current amplitude and pulse width should be programmed such that the
charge density is below 30 µC/cm
the software will display a warning when the level of stimulation exceeds 30 µC/cm
per stimulation phase; however, the software allows the stimulation to be adjusted
above this level by the physician.
Patients may have the ability to change the amplitude with the Remote Control.
Set and verify the maximum and minimum amplitude levels allowed by the Remote
Control to ensure that current levels remain safe.
Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should
not be used on patients implanted with the Vercise™ 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™ DBS System, causing tissue damage at the contact site
resulting in severe injury or death.
Magnetic Resonance Imaging. Patients implanted with the full Vercise DBS
System (leads, extensions and stimulator) should not be subjected to Magnetic
Resonance Imaging (MRI). MRI exposure may result in:
• 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 DBS System
components causing unpredictable levels of stimulation.
• Distortion of the diagnostic image.
• Personal injury or even death.
Note: Vercise DBS Lead-only system (before Stimulator is implanted) is MR
conditional. An MRI examination can be conducted safely when all
instructions in the supplemental manual MRI Guidelines for Boston Scientific
DBS Systems are followed.
For the latest version of the manual go to www.bostonscientific.com/manuals.
per stimulation phase. To maintain safety limits,
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Safety Information
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Physician Manual
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