9
Introduction
Production according to EU Directive
The medical device meets the requirements of Directive 93/42/EEC.
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in
compliance with the following directions:
> The medical device must be used in accordance with these Instructions for Use.
> The medical device has no components that can be repaired by the user.
> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 68).
> The electrical installation at the premises must comply with the regulations laid out in 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 medical device invalidates all claims under warranty and any other claims.
In addition to unauthorized assembly, installation, modification of or repairs to the control unit and non-compliance with our
instructions, improper use will void the warranty and release us from all other claims.
Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the
competent authority!
