Instructions For Use; Ipg Handling And Storage; Pre-Op Instructions; Ipg Implantation - Boston Scientific SC-1132 Instrucciones De Uso

Implantable Pulse Generator

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 Scientific Neuromodulation
Corporation. 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.
Note: Using the IPG 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.
Implantable Pulse Generator
90970875-06 Rev A 6 of 285
Production
Boston Scientific Confidential. Unauthorized use is prohibited.
Spectra IPG Entrada 2.0 19L
92070451 A.1
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