Intended Use; Lead Compatibility; Package Contents; Cautions - Boston Scientific Vercise M8 Mode D'emploi

Intended Use

The Vercise™ M8 Adapter is a 1 x 8 in-line
connector that is designed to connect specific
Medtronic™ Lead Extensions to the Boston
Scientific DBS System Stimulator, as part of a deep
brain stimulation procedure.

Lead Compatibility

The Boston Scientific Vercise M8 Adapter is
compatible with the following Medtronic Lead
Extensions:
• Model 3708640 Extension
• Model 3708660 Extension
• Model 3708695 Extension
• Model 3708540 Extension
• Model 3708560 Extension
• Model 3708595 Extension

Package Contents

Sterile
• (1) Vercise M8 Adapter
• (1) Hex Wrench
Non-sterile
• (1 set) Product identification stickers
• (1) Device registration form
Med A is sold separately.
The Instructions for Use (IFU) is provided
separately.

Cautions

• Inspect the condition of the sterile package
before opening the package and using the
contents. Do not use the contents if the
package is broken or torn, or if contamination
is suspected because of a defective sterile
package seal. Do not reuse, reprocess, or
resterilize.
• Do not use if the product is past the labeled
expiration date.
• Do not use if labeling is incomplete or
illegible.
• Do not bend, kink, or stretch the Extension
or Adapter; this may break its wires or
connections. Broken wires or connections
may create an open circuit, resulting in
component failure, loss of stimulation, and
potential surgical intervention.
• Do not handle the Vercise M8 Adapter with
instruments that were not supplied with
the Adapter. Other instruments may cause
damage to the device, including broken wires
or connections.
• The Set Screw in the Vercise M8 Adapter
must be retracted to insert the Lead
Extension. There is no stop feature to prevent
excessive retraction of the Set Screw and
disassembly of the Adapter. To avoid damage
to the sealing grommet, do not retract the
Set Screw assembly more than is needed to
insert the Lead Extension.
• Minimize the number of Hex Wrench
insertions into the Vercise M8 Adapter to
prevent damage to the septum seal plug.

Instructions for Use

1. Explant the Medtronic Stimulator, referring to
the appropriate Medtronic product labeling for
explant instructions.
2. Carefully open the Vercise M8 Adapter package
and transfer the contents of the inner tray to the
sterile field.
3. Ensure that the Medtronic Lead Extension is
clean and not damaged.
4. Retract the Set Screws in all Adapters: insert
the Hex Wrench into the septum containing
the Set Screw and turn the Hex Wrench
counter-clockwise (Figure 1).
Septum
Hex Wrench
Set Screw
Figure 1: The Set Screw assembly in the
Vercise M8 Adapter
Vercise M8 Adapter Instructions for Use
Intended Use
M8 Adapter
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