Instructions For Use; Securing The Base; Retaining Clip Placement - Boston Scientific SureTek DB-4600-C Mode D'emploi

Instructions for Use

Prior to securing the Base, a 14mm diameter burr hole should be prepared at the target site. Ensure
that the burr hole is free of obstructions, such as bone, that will prevent proper insertion of the Burr Hole
Cover. Visually inspect the Burr Hole Cover components to ensure that they are acceptable for implant.

Securing the Base

1. Place the Base attached to the Butterfly Holding Tool over the burr hole.
2. Using the Screwdriver gently push the Bone Screws through the Silicone Sleeve.
3. Tighten both Screws into the skull.
Note: Continue tightening the screws until the Base is flush to the skull and the screws are flush to the
Base. The Base should not move or rock once secured. Do not over-tighten the Screws or use
excessive force.
4. Grasp the handles of the Butterfly Holding Tool and remove it by pulling upward at an angle.
Note: The Butterfly Holding Tool can be replaced after rotating 90 degrees for full visibility of the screw
head position. This will allow for screw access while still covering the Burr Hole.

Retaining Clip Placement

For lead placement and removal instructions, refer to the appropriate DFU as listed on your DBS
Reference Guide.
1. Rotate the horseshoe end of the Placement/Removal Tool so that the tool is oriented as desired.
Instructions for Use
Burr Hole Cover Directions for Use
91062297-02 REV A 3 of 237