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WaveWriter Alpha™and WaveWriter Alpha™ Prime Implantable Pulse Generator
Instructions for Use
Boston Scientific recommends that healthcare providers who are implanting the Boston Scientific System
read all product labeling prior to using the Boston Scientific devices.
Preparation
1. Check that the sterile package is intact. See "Sterilization" on page 5 for additional instructions.
2. 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.
3. 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.
Charging Steps
The following instructions are to charge the rechargeable IPG without removing it from the packaging. For
instruction on charging an implanted IPG, refer to the Charger Handbook.
WARNING: While charging, the Charger may become warm. It should be handled with care.
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 light is amber, the
Charger is partially charged, but is still able to deliver a charge to the IPG.
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 IPG.
3. Place the Charger over the IPG. When the Charger is aligned with the IPG, the beeping will stop.
• Centering the Charger over the IPG will ensure the shortest charging time.
• Centering the Charger within the alignment area (the area where the Charger does not beep)
will also ensure that the Charger is aligned.
4. When the Charger emits a series of double beeps, the Stimulator is fully charged. Turn off the Charger,
and return it to the Base Station. Do not confuse the end of charge signal (a series of double beeps)
with the continuous beeps that indicate that the Charger is searching for the IPG.
Note: The Remote Control or the Clinician Programmer will not be able to communicate with the IPG
when charging.
IPG Battery Status
The patient Remote Control displays the IPG battery status when communicating with the IPG. Refer to
the Clinician Remote Control Instructions for Use for additional information. When the Remote Control
indicates that the IPG battery is low, the IPG should be recharged as soon as possible.
Failure to recharge may result in a loss of stimulation in less than 24 hours. After stimulation stops,
communication with the IPG will also cease. Until a sufficient level of charge has been attained, the IPG
may not communicate with the Remote Control.
Implantable Pulse Generator
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