Product Options; Summary Of Safety And Clinical Performance; Guidelines For It Security; Intended Use Environment - Advanced Bionics CI-6058-001 Instrucciones De Uso

PRODUCT OPTIONS

N/A
SUMMARY OF SAFETY AND
CLINICAL 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:- 08400944CI6058Y9
https://ec.europa.eu/tools/eudamed
Users of the AB Remote 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 AB Remote 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 AB Remote application is intended to operate with
Advanced Bionics Naída CI M and Sky CI M sound
processors and Phonak Naída Link M and Sky Link M
hearing instruments. 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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