5
Introduction
Production according to EU Directive
EU Directive 93/42/EEC has been used as a basis in the design and manufacture of this medical product and
this applies to the dental surgical units
– OsseoSet
TM
200 SI-915 and
– OsseoSet
TM
200 SI-923
in the condition as supplied by us. This declaration does not apply to non-specified fittings, mountings etc.
Responsibility of the manufacturer
The W&H Dentalwerk (dental factory) in Bürmoos can only accept responsibility for the safety, reliability and
performance of the OsseoSet
TM
200 when there is compliance with the following directions:
– OsseoSet
TM
200 must be used in accordance with these Instructions for Use.
– OsseoSet
TM
200 has no components which can be repaired by the user. Assembly, modifications or repairs
must only be undertaken by skilled personnel authorized by W&H.
– The electrical installation at the premises must comply with the regulations of ÖVE-EN 7 ("Installation of
electrical equipment in rooms used for medical purposes") or with the regulations applicable in your country.
– Unauthorized opening of the equipment invalidates all claims under warranty and any other claims.
