Ipg Explant Or Replacement; Rechargeable Stimulator System; Charging Steps - Boston Scientific SC-1132 Instrucciones De Uso

IPG Explant or Replacement

1. Turn off the IPG.
2. Surgically open the IPG pocket and withdraw the device. Please try to preserve the integrity of all
components so that complete device assessment can be performed.
3. Loosen the connector set screws to release and remove the leads, extensions, or splitters.
4. For replacement, connect the new IPG following the instructions for "Connecting the Lead, Extension,
Splitter, or Connector to the IPG" on page 9. Or, to terminate therapy, surgically remove the
implanted lead system.
5. Notify Boston Scientific to document the reason for explant or replacement and to arrange for return of
IPG and components.

Rechargeable Stimulator System

The Precision Spectra™ Stimulator is rechargeable. Boston Scientific recommends any recharge routine
that fits the patient's schedule and lifestyle while maintaining sufficient charge to maintain stimulation.
Developing a patient's recharge routine involves finding the right balance among the following:
• How much power is required for the patient to experience effective therapy.
• How often the patient wants to recharge.
• How long the patient wants to recharge.
• How the patient would like to manage their personal schedule.
The Precision Spectra Clinician Programmer will estimate charging time based on 24 hours per day of
stimulation at the programmed settings. To charge fully, wait until the Charger emits an end of charge
beep signal or the Remote Control display indicates that the battery is charged. Refer to the Patient's
Charger Handbook and the Physician's Remote Control Directions for Use for additional information. The
recharging process is simple, but important.

Charging Steps

WARNINGS:
• Patient should not charge while sleeping. This may result in a burn.
• While charging, the Charger may become warm. It should be handled with care.
• Failure to use the Charger with either the Charger Belt or an adhesive patch, as shown, may result
in a burn. If pain or discomfort is felt, cease charging and contact Boston Scientific.
The Charger Base Station should be plugged in and the Charger placed in the Base Station when not
in use. When the indicator light is green, the Charger is fully charged. When the indicator is amber, the
Charger is partially charged, but is still able to deliver a charge to the Stimulator.
1. When the indicator light is green, remove the Charger from the Base Station. The indicator light will
then turn off.
2. Press the power button. The indicator light will come on again, and the Charger will begin beeping as it
searches for the Stimulator.
3. Place the Charger over the Stimulator. When the Charger is aligned with the Stimulator, the beeping
will stop.
• Centering the Charger over the Stimulator will ensure the shortest charging time.
• Many patients are able to feel the implanted Stimulator and can place the Charger directly on
top of it.
Production
Boston Scientific Confidential. Unauthorized use is prohibited.
Spectra IPG Entrada 2.0 19L
Rechargeable Stimulator System
Implantable Pulse Generator
90970875-06 Rev A 11 of 285
92070451 A.1
Page 15 of 290