Precautions - Boston Scientific Vercise DBS Mode D'emploi

Physician Manual

Precautions

Physician training is required for usage of the Vercise™ 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.
Connections. Before inserting any DBS Lead or DBS Extension into any connector
or header ports, including the Stimulator header, DBS Extension connectors, and
operating room cable assembly, always wipe the DBS Lead with a dry cotton sponge.
Contamination inside the ports may be difficult to remove and can cause high
impedances, preventing electrical connectivity which may compromise the integrity
of the stimulation circuit.
Components. The use of components other than those supplied by Boston
Scientific and intended for use with the Vercise DBS System may: damage the
system, diminish the effectiveness of therapy, and/or put the patient at unknown risk.
Excess DBS Extension. Coil excess DBS Extension around or below the
Stimulator. Excess wire on top of the Stimulator may increase the potential for tissue
erosion or damage during Stimulator replacement surgery and may interfere with
charging.
Other Models of External Devices. Only the Remote Control, Clinician
Programmer, and Charger that were provided with the Boston Scientific Vercise™
DBS System should be used with the Vercise DBS System. Other models of these
devices will not function with the Vercise DBS System.
Stimulator Orientation. To ensure proper charging, orient the Stimulator
parallel to the skin surface and at a depth less than 2 cm below the skin. The etched
writing "This Side Up" must be facing out of the pocket towards the patients skin.
Suboptimal placement of the Stimulator may result in the inability to recharge and/or
a revision surgery.
Never attempt to change the orientation of or turn over the Stimulator. Patients should
avoid touching the Stimulator site or incisions. If the Stimulator flips over in the
body, then it cannot be charged. If stimulation cannot be turned on after charging,
the Stimulator may have changed orientation or rotated; patients should contact their
physician to arrange an evaluation of the system.
If a patient notices a change in appearance of the skin at the Stimulator location, such
as the skin becoming thin over time, they should contact their physician.
Setscrews. Before tightening Setscrews, always test impedance to confirm
electrical connectivity. Tightening a Setscrew onto a contact may damage the contact
and may result in the need to replace the DBS Lead or DBS Extension.
Physician Manual
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