Telemetry Information; Wireless Charging Information; Essential Performance; External Trial Stimulator - Boston Scientific WaveWriter Alpha Informacion Para Medicos

Information for Prescribers
• LE Privacy
• LE Secure Connections
Additionally, the WaveWriter Alpha and WaveWriter Alpha Prime Systems implement proprietary authentication and encryption that supports:
• Authenticated pairing sequences that are initiated by the healthcare provider
• Establishing a bonded connection only after successfully completing the authentication sequence
• Creating a validated and encrypted communication link during each connection with a previously paired device
The additional application level authentication and encryption ensures that communication with the Stimulator is only accomplished by authorized
Boston Scientific devices.

Telemetry Information

The following parameters describe the wireless communication link between the Remote Control or Clinician Programmer and IPG or ETS.
Frequency Band: 2.402 to 2.480 GHz
Modulation Type: GFSK
Maximum Radiated Power: 5 dBm
Protocol: Bluetooth Low Energy technology

Wireless Charging Information

Charging Frequency: 77 – 90 kHz
The charging distance between the Charger and the IPG is between 0.5 to 2 cm. Centering the charger over the stimulator ensures the shortest
charging time. The Charger will beep as it searches for the IPG and will stop beeping when it is aligned with the IPG. Please refer to the instructions
provided in the "Charging Steps" Section of IPG Directions for Use for instructions on aligning the Charger.

Essential Performance

External Trial Stimulator

The stimulation pulse shall meet the requirements for charge balance and amplitude while stimulation is on.

Other External Devices

Failure of the external electrical components will not result in an unacceptable risk to the user.

Electromagnetic Compatibility - EN 60601-1-2 Classification Information

• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
Guidance and Manufacturer's Declaration - electromagnetic emissions - for all ME Equipment and ME Systems
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in the electromagnetic environment specified below. The
customer or user of the IPG should assure that it is used in such an environment.
Emissions Test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are intended for use in the electromagnetic environment specified below. The
customer or the user of the WaveWriter Alpha or WaveWriter Alpha Prime System should assure that it is used in such an environment.
Wavewriter Alpha™ & WaveWriter Alpha™ Prime System Information for Prescribers
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Compliance Electromagnetic Environment Guide
Group 1 The WaveWriter Alpha and WaveWriter Alpha Prime Systems use RF energy only for its
internal function. Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class B The WaveWriter Alpha and WaveWriter Alpha Prime Systems are suitable for use in all
establishments. Including domestic establishments and those directly connected to the public
Class B
low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer's declaration – electromagnetic immunity