Product Info
Safety Information
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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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 or Clinician Programmer 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 be causing
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 SCS Systems utilize Bluetooth Low Energy for
communication. The WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems supported devices
implement the following Bluetooth Low Energy security features:
• LE Privacy
• LE Secure Connections
Additionally, the WaveWriter Alpha and WaveWriter Alpha Prime SCS 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 Scientic devices.
Clinician Programmer Security
The Clinician Programmer (CP) is a hardened computer with the following security controls:
• Access to the CP is restricted to authorized users and the CP screen locks out if there is no activity
and may only be unlocked with a password to prevent unauthorized access.
• The CP Platform enforces a password lockout duration after a predened number of unsuccessful
login attempts.
• Only authorized incoming connections are allowed.
• The encrypted le system restricts access of the data in the le system to authorized users only.
• Non-whitelisted applications cannot be installed.
• All BSN applications are code signed so that any compromise to their integrity via USB or other data
channels may be detected and prevented from execution.
• User actions and login attempts are logged by Windows Event Log.
• The CP logs and noties the user upon detection of malicious software.