English; Intended Use - GCE MEDIREG II Manuel D'utilisation

ENGLISH

INSTRUCTION FOR USE: MEDIREG® II, MEDISELECT® II
1 .
FOREWORD
GCE Medical Regulators are medical devices classified as class IIb according
EN
to the Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical Device
Directive is based upon EN 10524-1 standard.
2 .

INTENDED USE

GCE Medical Regulators are designed for use with high-pressure medical
gas cylinders equipped with a medical cylinder valve. They regulate pres-
sure and flow of medical gases to the patient. They are intended for the ad-
ministration of the following medical gases in the treatment, management,
diagnostic evaluation and care of the patient:
• Oxygen;
•
Nitrous oxide;
•
Air for breathing;
•
Helium;
•
Carbon dioxide;
•
Xenon;
•
Specified mixtures of the gases listed.
• Air or nitrogen to power surgical tools.
3 . OPERATIONAL, TRANSPORT AND STORAGE
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 fall-
ing over.
Always maintain oxygen cleanliness standards,
Use only the product and its associated equipment in a well ventilated
area.
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