Summary Of Safety And Clincial Performance; Guidelines For It Security; Intended Use Environment - Advanced Bionics Sky CI M90 Mode D'emploi

SUMMARY OF SAFETY AND
CLINCIAL PERFORMANCE
A summary of safety and clinical performance (SSCP)
is available in the European database on medical devices
(Eudamed), where it is linked to the Basic
UDI-DI:- 08400944CI5295YJ
https://ec.europa.eu/tools/eudamed
Users of the Sky CI M90 sound processor in the
European Union should report any serious incident to
their local competent authority and to Advanced Bionics.

GUIDELINES FOR IT SECURITY

Intended Use Environment

The Sky CI M90 sound processor system is intended for
use in healthcare and home environments. The home
environment is extended to include use outdoors and
during travel (e.g., airplanes). The Sky CI M90 sound
processor system is intended to operate with the AB Remote
application, the Phonak RemoteControl, the Target CI fitting
software, and with any Bluetooth-enabled device used for
audio streaming. The user is responsible for security of
connections with other devices, including pairing the sound
processor with other devices in a secure environment.
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