Intended Use - GCE MediFlowTec Instrucciones De Uso

ENGLISH
INSTRUCTION FOR USE:
MediFlowTec™, MEDIFLOW® II, MEDIFLOW +
1. FOREWORD
GCE Flow selectors are medical devices classified as class IIa according to
the Medical Device Directive 93/42/EEC.
The Compliance with essential requirements of 93/42/EEC Medical Device
Directive is based upon 15002 standard.

2. INTENDED USE

Mediflow are devices intended for the administration of the following med-
ical 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 flow selector 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.
Using variants with maximum flow 50 l/min is necessary to be more care-
ful and outlet of the flow selector MUST NOT be connected directly to the
patient, for example via cannula.
The set value on the flow selector does NOT indicate real the actual flow
of medical gas – the difference can be caused by different (missing) inlet
pressure or any fault on outlet hose (blocked, fold...)
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Keep away the product and its associated equipment from:
• heat sources (fire, cigarettes, ...),
• flammable materials,
• oil or grease
• water
• dust
The product and its associated equipment must be prevented from
falling over.
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