Intended Use - GCE VARIMED S400 Instrucciones De Uso

ENGLISH
INSTRUCTION FOR USE: VARIMED / S400
1. FOREWORD
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 EN ISO 10524-1 standard.

2. INTENDED USE

Pressure regulators are designed for connection to high-pressure cylinders
equipped with shut-off valves, and to distribution systems. They regulate
pressure and flow 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;
carbon dioxide;
•
xenon;
•
• specified mixtures of the gases listed.
air or nitrogen to power surgical tools.
•
3. OPERATIONAL, TRANSPORT AND STORAGE SAFE-
TY 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.
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EN