User Guide

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