The Axonics Sacral Neuromodulation System® complies to the EMC and wireless
requirements of the following standards:
• AIM 7351731:2017, Rev. 2.00
• ANSI IEEE C63.27:2017
• IEC 60601-1-2:2014, 4th ed
• IEC 60601-1-11:2015, 2nd ed.
• IEC /TR 60601-4-2:2016, 1st ed.
• ETSI EN 301 839 V2.1.1
• ETSI EN 302 537 V2.1.1
The Axonics Sacral Neuromodulation System® wireless communication uses
multiple MedRadio channels and includes Cyclic redundancy checks, packet
format checks, along with a retry scheme that improves the reliability of the
wireless link.
The Axonics RF wireless incorporates security measures that includes
authentication protocol comprising of a proprietary addressing scheme. The
majority of the RF wireless packets are short and infrequent. The operator
initiates all the interaction with the IPG/EPG, thus giving control to operator,
when to use the RF wireless function. Cyclic redundancy checks (CRC), packet
format checks, along with a retry scheme further assures the security &
reliability of the wireless link.
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