Pre-Op Instructions; Ipg Implantation - Boston Scientific WaveWriter Alpha Mode D'emploi

Implantable Pulse Generator

Pre-Op Instructions

1. For rechargeable IPGs, 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. See"Charging Steps" section in this manual for additional instructions.
2. Check that the sterile package is intact. (See "Sterilization" section in the Information for Prescribers
manual.)
3. If intraoperative stimulation testing is desired, ensure that an External Trial Stimulator (ETS) is
available for use. Ensure that stimulation is off (the ETS indicator light is not blinking) before opening
the battery compartment of the ETS. 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.
CAUTION: Do not use polypropylene sutures as they may damage the Suture Sleeve. Do not suture
directly onto the Lead, or use a hemostat on the Lead body. This may damage the Lead insulation. In
addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage
or serious patient injury.
3. Using the IPG Pocket Template, select and mark the intended IPG site, and create an incision for the
IPG pocket.
4. Create a subcutaneous pocket no larger than the IPG outline. For non-rechargeable IPGs, implant
at a depth of up to 2.5 cm from the surface. For Rechargeable IPGs, implant charging could become
ineffective at depths shallower than 0.5 cm or greater than 2.0 cm.
Note: Using the IPG Pocket Template will help guide the correct pocket sizing. It is important to keep the
pocket small to reduce the chances of patient manipulation and IPG flipping. Select an IPG site
several inches away from the previously externalized Trial Lead site to reduce risk of infection.
Note: For full-body MRI scan eligibility, confirm that the subcutaneous pocket for the IPG has been
created in the upper buttock or lower flank. (See the caution in "SCS Implant Conditions for Full
Body MRI Eligibility" section in this manual).
5. Tunnel the Lead(s) to the IPG site.
Implantable Pulse Generator
92469342-02 6 of 353