Intended Use - GCE EASE II Mode D'emploi

ENGLISH
INSTRUCTION FOR USE: EASE II
1. FOREWORD
GCE EASE II low pressure medical demand valves are medical devices classified as class IIa
according to the Medical Device Directive 93/42/EEC. Their Compliance with essential
requirements of 93/42/EEC Medical Device Directive is based upon BS 4272:1996 standard.

2. INTENDED USE

The GCE EASE II low pressure demand valve is designed to be fitted to medical gas pipeline
systems or to quick connector outlet of medical gas regulator. EASE II demand valves are
intended to be used under supervision for the administration of a medical gas in response to the
patient´s inspiratory effort. The EASE II Demand valve is intended for use in the administration of
the following medical gases in the treatment and care of patients and is suitable for use in the
hospital or pre-hospital (emergency medical) environments:
Oxygen O
•
2
Nitrous oxygen mixture O
•
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 falling over.
Always maintain oxygen cleanliness standards.
Use only the product and its associated equipment in well ventilated area.
Before initial use the product shall be kept in its original packaging. GCE recommends use of
the original packaging (including internal sealing bag and caps) if the product is withdrawn from
operation (for transport and storage). Statutory laws, rules and regulations for medical gases,
accident prevention and environmental protection must be observed.
OPERATING CONDITIONS
MIN
O2 -20 °C
O2/N2O +5 °C
10 %
600 mbar
/N O - 50/50%
2 2
MAX
+60°C
+60°C
100 %
1200 mbar
3/88
STORAGE AND TRANSPORT
CONDITIONS
MIN
-30 °C
20 %
600 mbar
EN
MAX
+60 °C
70 %
1200 mbar