Electromagnetic Compatibility Declaration Tables
The Trial Stimulator is intended for use in the electromagnetic environment
specified in the following EMC Declaration tables. The user of the Trial Stimulator
should assure that they are used in such an environment.
Note: The emission characteristics of this equipment make it suitable for use in
professional healthcare environment as well as residential environment
(CISPR 11 Class B). This equipment offers adequate protection to radio
communication service. In the rare event of interference to the 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.
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