Instructions For Use; Ipg Handling And Storage; Pre-Op Instructions; Ipg Implantation - Boston Scientific Precision Novi SC-1140 Instrucciones De Uso

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.
• 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 Scientific
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. Check that the sterile package is intact. (See "Sterilization" in the Information for Prescribers
manual.)
2. 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. The IPG pocket can be made
as deep as is comfortable for the patient.
5. Tunnel the lead(s) to the IPG site.
Note: Using the IPG template will help guide the correct pocket sizing. Select an IPG site
several inches away from the previously externalized trial lead site to reduce risk of
infection.
Precision Novi™ Implantable Pulse Generator Directions for Use
Instructions for Use
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