Table of Contents
Advertisement
Introduction
Hereby, W&H declares that the foot control is in compliance with Directive 2014/53/EU (RED).
The full text of the EU declaration of conformity is available at the following internet address https://wh.com
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.
> Only the components approved by the manufacturer may be replaced (O-ring).
> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 47).
> The foot control has no components that can be repaired by the user.
> 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.
Improper use, unauthorized assembly, modification or repair to the medical device, non-compliance with our instructions or the use
of accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any other claims.
Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the
competent authority!
10
Advertisement
Table of Contents
