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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.
1 - 02
References to applicable directives and legislation
EU Directives
Reference
Title
2014/35/EU
Low Voltage Directive
2017/745/EU
European Medical Devices Regulation
2014/29/EU
Simple Pressure Vessels Directive
2014/68/EU
Pressure Equipment Directive
EU Standards
Reference
Title
UNI EN ISO 14971
Medical Devices - Risk Management
CEI EN 60601-1-6
Medical electrical equipment. General requirements for basic safety
and essential performance
CEI EN 60601-1-2
Electromagnetic compatibility
CEI EN 60601-1-6
Usability
CEI EN ISO 15223-1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General requirements
EN IEE 82079-1
Preparation of instructions for use - structuring, content and
presentation
