Intended Use; Package Contents; Directions For Use - Boston Scientific Vercise M8 Adapter Instrucciones De Uso

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) Torque Wrench
Non-sterile
• (1 set) Product identification stickers
• (1) Device registration form
Med A is sold separately.
The Directions for Use (DFU) 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 setscrew in the Vercise M8 Adapter must
be retracted to insert the lead extension.
There is no stop feature to prevent excessive
retraction of the setscrew and disassembly
of the Adapter. To avoid damage to the
sealing grommet, do not retract the setscrew
assembly more than is needed to insert the
lead extension.
• Minimize the number of torque-wrench
insertions into the Vercise M8 Adapter to
prevent damage to the septum seal plug.

Directions 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 setscrews in all Adapters: insert the
torque wrench into the septum containing the
setscrew and turn the torque wrench counter-
clockwise (Figure 1).
Vercise M8 Adapter Directions for Use
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