User's Manual

5. Use the clinician programmer app to communicate with the IPG and perform intraoperative
testing to confirm that the system is operational. See the clinician's manual of the clinician
programmer app for instructions.
NOTE:
IPG output may not be identical to that of the trial stimulator at the same
settings.
6. Ensure that the IPG is away from the pocket incision suture line, close the pocket incision,
and apply the appropriate dressings.
Replacing the IPG
The following steps outline the suggested procedure to replace an IPG:
1. Turn off stimulation or verify that it is turned off.
CAUTION: Exercise care when using sharp instruments or electrocautery around
leads or extensions, or they may be damaged.
2. Open the IPG implant site per normal surgical procedure.
3. Insert the torque wrench through the septum of the IPG header and loosen the setscrew by
turning it counterclockwise.
CAUTION: When performing the following step, do not bend the lead or extension
sharply; or it may be damaged.
4. Gently remove the lead or extension from the IPG header; then clean and dry all
connections, ensuring they are free of fluid and tissue.
5. To complete the IPG replacement procedure, see the following sections: “Connecting a Lead
or Extension to the IPG (page 9) and Implanting the IPG” (page 10).
Disposing of Explanted Components
Explanted components should be returned to St. Jude Medical for proper disposal. To return an
explanted component, place it in a container or bag marked with a biohazard label and coordinate
the return with your St. Jude Medical™ representative or Technical Support.
Checking the Status of the IPG Battery
The IPG contains a nonrechargeable battery. The amount of time that the battery will provide
active stimulation depends on the patient’s stimulation settings and daily usage time. To check
the status of the IPG battery, use the clinician programmer app or patient controller app. The
clinician programmer app can also estimate how much time remains until the IPG battery can no
longer support stimulation. For more information about these functions, refer to the clinician’s
programming manual and the user’s guide for the patient controller app. For more information
about the estimated longevity of the IPG battery, see the product specifications in the appropriate
appendix in this manual.
NOTE:
Measurements of the IPG battery’s remaining life are unavailable until 8 days
after initial communication between the IPG and the clinician programmer app.
The following information provides general guidelines for the battery status:
A battery status icon on the patient controller app shows a decreasing fill as the battery is
used.
A warning will appear on the clinician programmer app or patient controller app when the
battery is almost depleted.
Stimulation will automatically stop when the battery cannot support stimulation.
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