Directions For Use - Boston Scientific Precision M8 Instrucciones De Uso

Precision™ M8 Adapter

Directions for Use

1. Refer to the appropriate Medtronic product
labeling for instructions on opening the
midline incision and explanting Medtronic lead
extensions or IPG.
2. Carefully open the Precision M8 Adapter
package and transfer the contents of the inner
tray to the sterile field.
3. Ensure that the Medtronic lead 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).
Septum
Torque Wrench
Setscrew
Figure 1: Location of setscrew in the
Precision M8 Adapter.
5. Ensure that stimulation is OFF before
connecting to the Precision M8 Adapter.
6. Ensure that the leads are clean before inserting
them into the Precision M8 Adapter.
7. Insert the proximal end of the lead into the
Precision M8 Adapter until the lead reaches the
end stop of the Adapter; use one Precision M8
Adapter for each 8-contact Medtronic lead tail
(Figure 2).
Medtronic Lead
M8 Adapter
Figure 2: Connection of Precision M8
Adapters to leads and IPG.
Precision™ M8 Adapter Directions for Use
90893429-10 REV B 2 of 80
M8 Adapter
Boston
Scientific
IPG
8. Ensure that the proximal end of the Precision
M8 Adapter is clean then:
• For permanent implant procedures, insert the
proximal end into a BSN Extension or BSN
IPG, referring to the section "Connecting the
Lead, Extension, Splitter or Connector to
the IPG" found in the IPG Directions for Use
or "Connecting to the IPG" in the Clinician
Manual for your spinal cord stimulator
system.
• For trial procedures, insert the proximal end
into a BSN Extension or BSN OR Cable,
referring to instructions for connecting the
External Trial Stimulator (ETS) in the Trial
Manual for your spinal cord stimulator
system. The Precision M8 Adapter can be
connected to a Boston Scientific ETS in
thesame manner as a Boston Scientific lead
orextension. Use standard aseptic dressing
technique at the exit site and at the Adapter/
lead junction for the duration of the trial
period.
9. Tighten the setscrew in the Precision M8
Adapter until the Torque wrench clicks,
indicating the setscrew is fully secured.
10. If the Precision M8 Adapter will be implanted,
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
setscrew 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