Intended Use - GCE MEDICONNECT-DUOLINE Manuel D'utilisation

ENGLISH
INSTRUCTION FOR USE: MEDICONNECT-DUOLINE
1. FOREWORD
MEDICONNECT-DUOLINE are medical devices classified as class IIa medi-
cal devices according to the Medical Device Directive 93/42/EEC. Their
compliance with the requirements of the 93/42/EEC Medical Device Direc-
tive is based upon the EN ISO 5359 standard.

2. INTENDED USE

MEDICONNECT-DUOLINE are intended for the transfer of medical gases
or vacuum, and/or the connection of two medical products (e.g. a pressure
regulator with an emergency ventilator).
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:
• heat sources (fire, cigarettes, ...),
• Flammable materials
• oil or grease (especially be careful in use of hand cream)
• Water
• Dust.
The product and its associated equipments must be prevented from fall-
ing over.
Always maintain oxygen cleanliness standards.
Use the product and its associated equipment in well ventilated areas
only.
Statutory laws, rules and regulations for medical gases, accident preven-
tion and environmental protection must be observed.
All accidents must be reported to GCE immediately.
4. PERSONNEL INSTRUCTIONS AND TRAINING
According to Medical Devices Directive 93/42/EEC the product owner
must ensure that all personnel handling the product are provided with the
operating instructions & performance data and are fully trained
to carry out that operation. Trainees need to be supervised by an experi-
enced person.
Do not use the device without being trained. Training can be only done
by a person with an appropriate education, experience and knowledge
that has been also trained by the manufacturer.
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EN