Intended Use - GCE MediVital Instrucciones De Uso

1.
FOREWORD
The product complies with the essential requirements of 93/42/EEC Medical Device Directive
and Transportable Pressure Equipment Directive 2010/35 EU. The combination valve is
designed according to EN ISO 10524-3 and EN ISO 10297 standards.
EN
2.

INTENDED USE

MediVital
gases. These combination valves together with a gas cylinder form gas packages used either
as gas supply point for medical devices (anaesthetic devices, ventilating devices, incubators
etc.) or for direct gas supply 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
•
Mixtures of the gases listed above
3.
OPERATIONAL, TRANSPORT AND STORAGE SAFETY
REQUIREMENTS
KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:
•
Heat sources (fire, 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.
Always maintain oxygen cleanliness standards.
Only use the product and its associated equipment in well ventilated area.
Before the first use the product shall be kept in its original package. If removed from service
(for transport, storage) GCE recommends using the original package (including inner packing
materials).
National laws, rules and regulations for medical gases, accident prevention and environmental
protection must be observed.
*for inner tightness of the shut-off valve, during transport and storage of the combination valve
mounted on a cylinder, the valid lower temperature limit is -40°C.
Combination Valves are designed to be fitted to gas cylinders used for medical
®
OPERATING CONDITIONS
-20* / +65 °C
10 / 100 %
600 / 1200 mbar
STORAGE AND TRANSPORT CONDITIONS
2/104
-40 / +70 °C
10 / 100 %
600 / 1200 mbar