Bernafon Acriva - Compliance with Requirements for Europe

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Compliance with Requirements
for Europe
All devices covered in these instructions for use
are in conformance with the requirements of the
Directive 93/42/EEC of the Council of the European
Communities concerning medical devices, MDD.
This is certied by applying the following marking:
All devices with wireless functionality (Juna, Acriva,
Carista, and Chronos, see also pages 6 – 8)
also comply with the essential requirements of the
Directive 1999/5/EC of the European Parliament on
radio equipment and telecommunications terminal
equipment, R&TTE. It operates as an inductive
application in a harmonized frequency band according
to the Commission Decision 2008/432/EC and may
be used in all member states of the EU and EFTA.
This is certied by applying the following marking:
Declaration of conformity is available at:
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland