Instructions For Use; Pre-Conditions; Implanting The Dbs Lead - Boston Scientific Vercise DBS DB-2201-30AC Mode D'emploi

Vercise™ DBS Lead Directions for Use

Instructions for Use

Pre-Conditions

The described implant procedures start with implanting the DBS Lead. It is assumed that the
following procedures have been completed:
• The stereotactic frame and/or fiducials of a frameless system are attached to the patient.
• The desired trajectory of the DBS Lead insertion path has been determined.
• The incision in the scalp has been made and the burr hole drilled.
• If using the SureTek™ Burr Hole Cover, the Base of the Burr Hole Cover has been
affixed over the burr hole. (See the manual provided with the Burr Hole Cover Kit for
instructions for use.)
• The desired trajectory and DBS Lead depth may have been verified by microelectrode
recording or an appropriate means.

Implanting the DBS Lead

The DBS Lead will be implanted and the therapeutic benefit verified.
1. Prepare DBS Lead for implant. Visually inspect the DBS Lead and determine it to be
acceptable for implantation.
2. Pass the DBS Lead through the cannula to ensure proper fit.
3. Insert the cannula (with cannula stylet) into the brain to the desired depth.
Note: Cannula depth depends on physician's preference.
4. Assemble the Lead Stop (Figure 1) by partially screwing the threaded portion of the screw into
the threaded hole in the Ring.
5. Measure the desired depth of DBS Lead with a gauge or ruler and apply the DBS Lead Stop
at that length. To apply the DBS Lead Stop, push the DBS Lead to the center of the Lead Stop
and then tighten the Screw (Figure 2). This will ensure that the DBS Lead will be inserted to the
proper depth.
Note: Make sure the Lead Stop will not slide on the DBS Lead when engaged.
Vercise™ DBS Lead Directions for Use
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Figure 1: DBS Lead Stop