8
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 device and it applies to the
dental surgical units
> Implantmed SI-915 and
> Implantmed 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 manufacturer can only accept responsibility for the safety, reliability and performance
of the Implantmed when it is used in compliance with the following directions:
> The Implantmed must be used in accordance with these Instructions for use.
> The Implantmed has no components that can be repaired by the user. Assembly, modifications or repairs must only be
undertaken by an authorized W&H service partner (see page 52).
> The electrical installation at the premises must comply with the regulations of IEC 60364-7-710 (»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.
