Estimating Longevity (For Non-Rechargeable Systems); Elective Replacement (For Non-Rechargeable Systems); Quality Of Wireless Service; Timing - Boston Scientific WaveWriter Alpha Informacion Para Medicos

When the IPG battery is fully depleted, the End of Service (EOS) indicator will be displayed on the Remote Control and Clinician Programmer.
Stimulation will not be available. Surgery is required to replace the implanted non-rechargeable stimulator to continue providing stimulation.

Estimating Longevity (for Non-Rechargeable Systems)

After the optimal settings have been identified for a program, click on Battery Estimate in the Program Options Menu in the Bionic Navigator™ 3D
software to obtain the Energy Use Index. Use Figure 1 (if estimated usage of stimulation is 12 hours) or Figure 2 (if estimated usage of stimulation
is 24 hours) to identify the longevity that corresponds to this Energy Use Index. Figures 1 and 2 take into account nominal non-therapy power
consumption, including shelf-life and patient remote control use. If the estimate for longevity obtained by these Figures is below 12 months, consider
evaluating a Boston Scientific rechargeable system.
Energy Use Index
Figure 1: Longevity estimates based on 12 hour per day usage
Example: Estimating Battery Longevity with Nominal Program Settings
Nominal Program Settings*
4.1 mA, 280 us, 40 Hz, 1 area, 730 Ohms, 2 contacts
*Nominal settings based on Oakley et al. Stimulation Power by Disease Diagnosis in Spinal Cord Stimulation. Presented at American Academy of
Pain, 2006.

Elective Replacement (for Non-Rechargeable Systems)

When the battery is nearing depletion, the IPG will enter the Elective Replacement mode. The Elective Replacement Indicator (ERI) will appear on
the Remote Control and Clinician Programmer. Failure to replace the IPG may lead to reduced programming capabilities, limited communication
with the stimulator, and stimulation not being available soon. The stimulator must be replaced to continue receiving stimulation. Batteries that have
lasted 12 months or more without entering ERI mode will have a minimum of 4 weeks between entering ERI mode and reaching End of Battery Life.
Surgery is required to replace the implanted non-rechargeable Stimulator, although leads may stay in place while the stimulator is exchanged.

Quality of Wireless Service

The WaveWriter Alpha and WaveWriter Alpha Prime Systems use a Half-Duplex, direct point-to-point, primary-secondary communication system
based on Bluetooth® Low Energy technology with the following typical communication range:
• Between the Remote Control and IPG: 3 meters
• Between the Remote Control and ETS: 6 meters • Between the Clinician Programmer and ETS: 6 meters
Data will be resent if not successfully received on supported devices. Sources of in-band high interference may result in slow connection, difficulty
when pairing devices, or both. If you experience any of these, you may need to decrease the distance between the communicating devices. For
information on how to improve connection issues, see "Troubleshooting Wireless Coexistence Issues" on page 5.

Timing

When a user initiates a communication session, the system will typically respond in 1 to 6 seconds. The typical data throughput during active
programming session will be more than 10 kbs.

Troubleshooting Wireless Coexistence Issues

Other wireless and RF technology based equipments operating in the close proximity that uses similar frequency band may degrade the range and
responsiveness of the System. If you experience issues with the wireless communication behavior between the Remote Control and IPG or ETS, try
the following steps to correct the behavior:
• Decrease the distance between the two devices if possible.
• Ensure there are no objects between the communicating devices.
• Move the communicating devices away from other equipment or devices that may cause interference, such as Wi-Fi routers, Cordless Phones,
Bluetooth Wireless streaming devices, Baby Monitors, Microwave Ovens.

Wireless Security

The WaveWriter Alpha and WaveWriter Alpha Prime Systems utilize Bluetooth Low Energy for communication. The WaveWriter Alpha and
WaveWriter Alpha Prime Systems supported devices implement the following Bluetooth Low Energy security features:
Figure 2: Longevity estimates based on 24 hour per day usage
Energy Use Index Mode of Operation
10 Hours of stimulation per day: 12
• Between the Clinician Programmer and IPG: 3 meters
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
Quality of Wireless Service
Energy Use Index
Battery Longevity
Approximately 5.1 years
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