4tek MIRAGE Operating And Maintenance Manual page 7

MIRAGE Line Compressors Instruction Manual
Contents and purpose of the manual
This manual contains technical specifi cations, performance details, transport and installation
instructions, operating instructions and preventive and corrective maintenance operations of
the equipment manufactured by 4tek S.r.l.
Any change, addition, or removal of elements, components or functions of the equipment,
unless agreed beforehand with 4tek S.r.l., will automatically relieve the manufacturer of all
liability.
This manual, which is intended for the users of the equipment and technicians entrusted with
its maintenance , provides the main technical data of the system , a technical description of
the various functional units of which it is composed, as well as the main operating procedures
and information needed to perform preventive and corrective maintenance operations.
The manual is addressed to persons with a sound knowledge of the manufacturing or
processing method and is intended for the use both of operators and of service technicians.
This manual contains information on the equipment to ensure conditions of safety for all users
and to guarantee perfect effi ciency of the equipment throughout its entire working life.
To ensure correct use of the equipment, the workplace must be compliant with current health
and safety regulations.
References to applicable directives and legislation
EU Directives
Reference
2014/35/EU
2017/745/EU
2014/29/EU
2014/68/EU
EU Standards
Reference
UNI EN ISO 14971
CEI EN 60601-1-6
CEI EN 60601-1-2
CEI EN 60601-1-6
CEI EN ISO 15223-1 Medical devices - Symbols to be used with medical device labels,
EN IEE 82079-1
This manual is the property of
Title
Low Voltage Directive
European Medical Devices Regulation
Simple Pressure Vessels Directive
Pressure Equipment Directive
Title
Medical Devices - Risk Management
Medical electrical equipment. General requirements for basic safety
and essential performance
Electromagnetic compatibility
Usability
labelling and information to be supplied - Part 1: General requirements
Preparation of instructions for use - structuring, content and
presentation
. No part of it may be reproduced in any form.
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