W&H Assistina Twin MB-302 Instructions For Use Manual page 8

Introduction
Production according to EU Regulation
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 the exception of replacing the O-rings,
cartridges, filter and air filter). Assembly, modifications or repairs must only be undertaken by an authorized W&H service
partner (see page 53).
> 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 equipment invalidates all claims made under warranty and any other claims.
Improper use
Improper use and unauthorized assembly, installation and modification of or repairs to the medical device or failure to comply with
our instructions invalidates all claims under warranty and releases 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!
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