Axonics 2501 Bedienungsanleitung Seite 5

healthcare environment. If it is used in a residential environment (for which
CISPR 11 Class B is normally required) this equipment might not offer
adequate protection to radio communication service. The user might need
to take mitigation measures, such as relocating or re-orienting equipment.
Essential Performance
Any failure within the Axonics Sacral Neuromodulation System does not result in
performance that can lead to unacceptable risk to the user or patient.
Quality of Wireless Service
The Axonics Sacral Neuromodulation System uses the Half-Duplex, Direct
point-to-point, primary-secondary communication system in the FCC MedRadio
frequency band (401 MHz – 406 MHz) with the following characteristics:
• Typical communication range: Clinician Programmer and Stimulator
communication range is 3 m.
• Typical RF output transmit power: 25 uW EIRP (Effective Isotropic Radiated
Power)
• Typical Timing: Once a command is initiated by the user, the system will
respond within 5 seconds (Note: Once the initial link is established, further
packets are transmitted and received with typical latencies that are less than
half a second)
• Communication failures:
◊ The Axonics RF wireless authentication protocol comprises of a proprietary
scheme to allow communication to only the other Axonics system
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