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INSTRUCTION FOR USE: MEDIREG® II, MEDISELECT® II
1. FOREWORD
GCE Medical Regulators are medical devices classifi ed 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 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
pressure and fl ow of medical gases to the patient. They are intended
for the administration of the following medical gases in the treatment,
management, diagnostic evaluation and care of the patient:
•
Oxygen;
•
Nitrous oxide;
•
Air for breathing;
•
Helium;
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 falling
over.
Always maintain oxygen cleanliness standards,
Use only the product and its associated equipment in a well ventilated
area.
•
Carbon dioxide;
•
Xenon;
•
Specifi ed mixtures of the gases listed.
•
Air or nitrogen to power surgical tools.
3/195
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