9
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 it applies to the
dental surgical unit
> Elcomed SA-310
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 Elcomed
when it is used in compliance with the following directions:
> The Elcomed must be used in accordance with these Instructions for use.
> The Elcomed 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 72).
> 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 device invalidates all claims under warranty and any other claims.