45
USER GUIDE miniBTE
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 certified by
applying the following marking:
All devices with wireless functionality 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 certified by applying the
following marking:
Declaration of conformity is available at:
Sonic Innovations, Inc.
2501 Cottontail Lane
Somerset, NJ 08873
0543 0682
Waste from electronic
equipment must be handled
according to local regulations.
E2832
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