Sterilization; Technical Service; End Of Programmed Service; Ipg Battery Life - Boston Scientific WaveWriter Alpha Informacion Para Medicos

Information for Prescribers

Sterilization

All implantable and surgical components, of the WaveWriter Alpha and WaveWriter Alpha Prime Systems, are sterilized with ethylene oxide.
Inspect the condition of the sterile package before opening the package and using the contents. Do not use the contents if the package is broken or
torn, or if contamination is suspected because of a defective sterile package seal.
• Do not use any component that shows signs of damage.
• Do not resterilize the package or the contents. Obtain a sterile package from Boston Scientific.
• Do not use if the product is past the labeled expiration date.
• All components are for single use only. Do not reuse.
• Do not use if package is opened or damaged.
• Do not use if labeling is incomplete or illegible.
WARNING: Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call
your Boston Scientific representative.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of
the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also
create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Technical Service

There are no user serviceable parts. If you have a specific question or issue, please contact your Boston Scientific representative.

End of Programmed Service

The WaveWriter Alpha and WaveWriter Alpha Prime Systems use a software that programs the IPG to end service after 12 years. As the IPG nears
the end of the programmed period, the Remote Control and Clinician Programmer provide the following indicators to inform the user that the end of
the programmed period is approaching:
• Remote Control - Approximately six months before the end of programmed period, the Remote Control displays a weekly message indicating the
number of service days remaining. Approximately one month before the end of the programmed period, the message displays daily.
• Clinician Programmer - When less than six months of service remain, an indicator displays on the Connect screen of the Clinician Programmer.
When end of the programmed period has been reached, a message displays when connecting to the Stimulator to indicate that end of the
programmed period has been reached and programming is not allowed.
Patients should contact their healthcare provider upon first receiving a message regarding the number of service days remaining.
Note: End of Programmed Service is applicable to the WaveWriter Alpha Prime System only when battery longevity is greater than 12 years.

IPG Battery Life

Rechargeable Systems

The rechargeable battery in the WaveWriter Alpha System IPG should provide at least five years and up to 25 years or more of service
is dependent on your stimulation settings and conditions. In most cases, the Stimulator will need to be recharged at intervals ranging from once a
week to once a month. Over time, the IPG battery will need more frequent recharges. Like all rechargeable batteries, use over time and repeated
recharge cycles reduce the maximum charge capacity of the IPG battery.

Non-Rechargeable Systems

The WaveWriter Alpha Prime IPG has a non-rechargeable battery. The longevity of the non-rechargeable IPG battery depends on the following
factors:
• Programmed parameters (i.e., amplitude, rate, pulse width, number of electrodes used, and number of stimulation areas)
• System impedance
• Use of cycling or burst settings
• Hours per day of stimulation
• Changes made by the patient to programmed parameters
It is possible to estimate the battery longevity of a new IPG based on usage over 12 or 24 hours per day with a selected Program. The estimate is
based on the settings of a program, the system impedance at time of estimation, and the hours per day of stimulation.
These estimates will not reflect adjustments to stimulation parameters or changes in impedance. The estimate functions as a reference value to
approximate the period that a new WaveWriter Alpha Prime stimulator will last (see Estimating Longevity section). Battery life is dependent on your
stimulation settings and conditions.
Note: If the WaveWriter Alpha Prime System is being considered for permanent implant, it is recommended that the battery longevity of the
WaveWriter Alpha Prime IPG be estimated during the trial. It is also recommended to estimate the battery longevity at the initial programming
of the implant.
Note: Estimations made after initial programming of the IPG may overestimate the longevity of its battery.
1 The expected years of battery operation are defined as the longer of either:
A. Typical case: the time at which therapy cannot be maintained with daily charging.
or
B. High energy case: when the maximum recharge interval has decreased by more than 50 % from the initial recharge interval.
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
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