9
Introduction
Production according to EU Directive
The medical device meets the requirements of Directive 93/42/EEC.
The foot control meets the requirements of Directive 93/42/EEC and RED Directive 2014/53/EU.
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, coolant filter, pump cartridge).
> Modifications or repairs must only be undertaken by an authorised W&H service partner (see page 47).
> The medical device 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.
