Instructions for Use
Percutaneous Leads Directions for Use
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9. Use the hex wrench supplied to tighten down the setscrews until the wrench clicks.
Medical Adhesive
10. If using the Splitter 2x8, prior to closing the wound, clean the top of the splitter set-screw seal plug and
use silicone medical adhesive (e.g. Dow Corning Silastic® Medical Adhesive Silicone, Type A - Sterile,
as available from Boston Scientific, part number SC-4320) to coat and seal the top of the seal plug that
has been penetrated by the hex wrench.
Note:
Inadvertent damage to the septum seal may lead to unintended stimulation at the Splitter
2x8 if the Medical Adhesive is not used as intended.
11. To connect to a Trial Stimulator for intraoperative testing, or to connect to an IPG, proceed to the
applicable instructions in the appropriate DFU for your SCS System as listed in your
Reference Guide
.
Intraoperative Stimulation Testing
Note:
The following steps are for procedural reference only. For detailed stimulation testing
procedures and guidelines refer to the appropriate programming manual for your SCS
system as listed in the Reference Guide.
1. If using a splitter
•
Visually check splitter to leads connection
•
Check impedance
Note:
If using the 2x4 Splitter, make note of splitter configuration in the Programming software.
Refer to the appropriate programming manual for your SCS System as listed in your
Reference Guide.
2. After linking the Clinician Programmer to the Trial Stimulator, check impedances to verify that components
are properly connected. Lead impedance is measured and displayed for each of the IPG’s contacts.
Impedances, indicated by an x or an orange circle in your Programming Software, are considered
to be resultant from open or unconnected wires. Refer to your
Programming Manual
for additional
information.
3. Using test stimulation, enlist patient feedback to verify lead placement and pain coverage.
Note:
If lead repositioning is necessary, turn stimulation off before proceeding.
4. Reposition leads as necessary. If using a splitter, gently pull on lead attached to splitter to reposition
caudad or disconnect splitter from leads, re-insert stylet, and advance leads to reposition cephalad.
CAUTION:
Do not force stylet into lead.
5. Steer lead to new position.
6. Remove stylet, wipe proximal ends of leads, and reconnect splitter.
7. Check impedances.
8. Repeat steps 1-3 if lead has been repositioned.
