8
Introduction
Production according to EU Directive
The medical device meets the requirements of Regulation (EU) 2017/745
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 (with exception of replacing the o-rings, cartridges,
filter and air filter). Assembly, modifications or repairs must only be undertaken by an authorised W&H service partner.
(see page 37)
> 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!
