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4. 1 .
FOREWORD
GCE Flowmeters are medical devices classified as class IIa according to the Medi-
cal Device Directive 93/42/EEC.
The Compliance with essential requirements of 93/42/EEC Medical Device Direc-
tive is based upon ISO 15002 standard.
4. 2 .
INTENDED USE
Flowmeter is a device intended for the administration of the following medical
gases in the treatment and care of patients:
•
oxygen
•
medical air
•
nitrous oxide
The product is not intended to be use with air or nitrogen for driving surgical tool.
This low pressure regulator is intended to be fitted to medical gas pipeline system
terminal units in hospital or ambulance car or to quick connector outlet of medical
regulator, with nominal pressures up to 5 bar.
4. 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, (especially be careful if hand cream is used)
•
water,
•
dust.
•
The product and its associated equipment must be prevented from falling
over.
Use only the product and its associated equipment in well ventilated area.
Always maintain oxygen cleanliness standards.
Before initial use the product should be kept in its original packaging. GCE recom-
mends 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.
OPERATION CONDITIONS
-20/+60 °C
10/100%
600/1200 mbar
In case of storage at a temperature below -20 °C, do not operate the flow
selector until it has been allowed to increase its temperature to a minimum
of -20 °C.
O
2
Air
N
O
2
STORAGE AND TRANS-
PORT CONDITIONS
-30/+60 °C
10/100%
600/1200 mbar
3/32
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