Intended Use - GCE COMBILITE Serie Instrucciones De Uso

1 FOREWORD
The product complies with essential requirements of 93/42/EEC Medical Device Directive and
99/36/EEC Transportable Pressure Equipment Directive.
The valve is designed according to EN ISO 10524-3 standard.

INTENDED USE

2
Combilite Combination Valves are designed to be fitted to gas cylinders used for medical
gases.
These combination valves with a gas cylinder form medical gas packages used either as gas
supply point for medical devices (anaesthetic devices, ventilating devices, incubators etc.) or
EN
for direct gas supplying to a patient's breathing mask or cannula.
GCE Combination Valves are intended to be used with the following medical gases:
• oxygen;
•
nitrous oxide;
• air for breathing;
• helium;
•
carbon dioxide;
3 OPERATIONAL, TRANSPORT AND STORAGE SAFETY
REQUIREMENTS
Keep the product and its associated equipment from:
• heat sources (fire, cigarettes, e-cigarettes,...)
• flammable materials,
• oil or grease (take a great care in the use of hand creams),
• water,
• dust.
the product and its associated equipment must be prevented from tipping over, turning
over or falling.
Maintain always oxygen cleanliness standards.
Use only the product and its associated equipment in well ventilated area.
Before the first use the product shall be located in its genuine package. In case of removal
from service (for transport, storage) GCE recommends using the genuine package (including
inner cushioning materials).
National laws, rules and regulations for medical gases, accident prevention and environmental
protection must be observed.
OPERATING CONDITIONS
-20 / +60 °C
10 / 100 %
600 / 1200 mbar
• xenon;
•
specified mixtures of the gases listed;
• air for driving surgical tools;
• nitrogen for driving surgical tools.
STORAGE AND TRANSPORT
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CONDITIONS
-30 / +60 °C
10 / 100%
600 / 1200 mbar