Boston Scientific Vercise M8 Gebrauchsanweisung Seite 4

Vercise™ M8 Adapter
Septum
Set Screw
Figure 1: The setscrew assembly in the
Vercise M8 Adapter
5. Ensure that stimulation is OFF before
connecting to the Vercise M8 Adapter.
6. Ensure that the lead extension is clean before
inserting into the Vercise M8 Adapter.
7. Insert the proximal end of the Medtronic lead
extension into the Vercise M8 Adapter until the
extension reaches the end stop of the Adapter;
use one Vercise M8 Adapter for each Medtronic
lead extension (Figure 2).
Figure 2: Connection of Vercise M8 Adapters to
Medtronic lead extensions and Boston Scientific
DBS Stimulator.
8. Ensure that the proximal end of the Vercise
M8 Adapter is clean then insert the proximal
end of the Adapter into the Boston Scientific
DBS Stimulator. For further instructions on
connecting to the stimulator, refer to the
appropriate DFU for your Boston Scientific DBS
System as listed on your Reference Guide.
Vercise M8 Adapter Directions for Use
90903595-06 2 of 84
Torque Wrench
M8 Adapter
Boston Scientific
DBS Stimulator
9. Perform the permanent Stimulator implantation
procedure. For instructions on implanting the
stimulator, refer to the appropriate DFU for your
Boston Scientific DBS System as listed on your
Reference Guide.
NOTE: Do not place the distal segment of the
Vercise M8 Adapter between its proximal end and
the Boston Scientific DBS Stimulator. Placement
of wires between these two devices could result in
damage to the wire insulation resulting in loss of
stimulation.
NOTE: Do not wrap or coil the excess extension
wires or the distal Adapter segment around the
perimeter or in front of the stimulator. Wrapping
around the stimulator may cause wires to slip in
front of the stimulator. Placing wires in front of the
stimulator may cause kinking of the extension and
Adapter wires, potential interference with telemetry
and/or recharge operation, and damage during
future stimulator replacement surgery.
10. Tighten the setscrew in the Vercise M8 Adapter
until the Torque Wrench clicks, indicating the
setscrew is fully secured
11. Apply a medical adhesive (e.g. Dow Corning
Silastic® Medical Adhesive Silicone, Type-A
Sterile, as available from Boston Scientific, part
no. SC 4320) to coat and seal the top of the set
screw port (Figure 3).
Medical Adhesive
Figure 3: Medical adhesive covering the septum
seal plug.
NOTE: Damage to the septum seal may lead to
unintended stimulation at the implantation site if
medical adhesive is not used as intended.
M8 Adapter