Intended Use - gce mediline Varimed Instrucciones De Uso

FOREWORD
1.
GCE Medical Regulators are medical devices classified as class IIb according
to the Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical Device
Directive is based upon ISO 10524-2 standard.

INTENDED USE

2.
EN
Pressure regulators equipped with gas cylinder inlet connection are to be used
in emergency as back up gas supply for the hospital pipeline system. They
are NOT designed for direct use with patient. They are intended for the
administration of the following medical gases:
•
oxygen;
•
nitrous oxide;
•
air for breathing;
•
helium;
OPERATIONAL, TRANSPORT AND STORAGE
3.
SAFETY REQUIREMENTS
Keep the product and its associated equipment away from:
• All sources of heat
• Flammable materials
• Oil or grease (including all hand creams)
• Water
• Dust.
The product and its associated equipment must be prevented from
falling over.
Always maintain oxygen cleanliness standards.
Use only the product and its associated equipment in a well ventilated
area.
Before initial use the product should be kept in its original packaging. GCE
recommends use of the original packaging (including internal sealing bag and
caps) if the product is withdraw from operation (for transport, storage).
Statutory laws, rules and regulations for medical gases, accident prevention
and environmental protection must be observed.
PERSONNEL INSTRUCTIONS AND TRAINING
4.
The Medical Devices Directive 93/42/EEC states that the product provider must
ensure that all personnel using the product are provided with the instructions
for use and are fully trained in the use of the equipment.
Do not use the product without proper training! Trainees must be trained
by an experienced person who has been authorised by the manufacturer
and has an appropriate education, knowledge and experience.
•
carbon dioxide;
•
xenon;
•
specified mixtures of the gases listed.
•
air or nitrogen to power surgical tools.
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