Boston Scientific Vercise M8 Mode D'emploi page 6

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).
Boston Scientific
DBS Stimulator
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 IFU for your Boston Scientific
DBS System as listed on your DBS Reference
Guide.
9. Perform the permanent Stimulator implantation
procedure. For instructions on implanting the
Stimulator, refer to the appropriate IFU for your
Boston Scientific DBS System as listed on your
DBS 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
Vercise M8 Adapter Instructions for Use
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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.
NOTE: If the Vercise M8 Adapter is placed or
moves superficial to the Stimulator, it could cause
communication or charging difficulties.
10. Tighten the Set Screw in the Vercise
M8 Adapter until the Hex Wrench clicks,
indicating the Set Screw 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.
12. To program Leads, refer to the contact-mapping
diagram (Figure 4) and instructions provided
in the programming manual provided for your
Boston Scientific DBS System.
Medtronic Lead M8 Adapter
Figure 4: Contact mapping with the Vercise
M8 Adapter
13. Complete the device registration form included
in the Vercise M8 Adapter package. Use the
product identification stickers, where necessary.
M8 Adapter