User's Manual

Implantable Pulse Generator

90655621-03 Rev A 4 of 11

Instructions for Use

IPG Handling and Storage

• Handle the IPG and all components with care.

• Keep sharp instruments away from the components.

• Do not use the IPG if it has been dropped on a hard surface.

• Do not incinerate an IPG. Improper disposal of the device could result in an explosion.

Devices should be explanted in the case of cremation, and returned to Boston Scientiﬁ c

Neuromodulation. An explant kit is available.

• Store the IPG between 0 °C and 45 °C ( 32°F and 113 °F). Devices should always

be kept in temperature regulated areas within the acceptable temperature range. IPG

damage can occur at temperatures outside of this range.

Pre-Op Instructions

1. Ensure that the IPG is fully charged prior to the permanent implant procedure. The

approximate location of the IPG is marked on the IPG kit. Turn on the Charger and place

it over the IPG to begin charging. Refer to “Charging Steps” in this manual for additional

instructions.

2. Check that the sterile package is intact. (See “Sterilization” in the Information for Prescribers

manual.)

3. If intra-operative stimulation testing is desired, ensure that a Trial Stimulator is available for

use. Refer to the Clinician Trial Manual for additional instructions.

IPG Implantation

1. Ensure that the area surrounding the lead entry site is incised to a dimension that will

accommodate the tunneling tool.

2. Check that the lead is securely anchored.

3. Select and mark the intended IPG site, using the IPG template, and create an incision for

the IPG pocket.

4. Create a subcutaneous pocket no larger than the IPG outline at a depth of up to 2.0 cm

from the surface. Implant charging could become ineffective at depths shallower than

0.5 cm or greater than 2.0 cm.

5. Tunnel the lead(s) to the IPG site.