GCE MEDIFLOW ULTRA II Instrucciones De Uso página 2

ENGLISH
INSTRUCTION FOR USE: MEDIFLOW® ULTRA II
EN
1. FOREWORD
GCE Medical Regulators are medical devices classifi ed as class IIa accord-
ing to the Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical De-
vice Directive is based upon EN 10524-4 standard.
This instruction for use covers essential information for the whole life cycle
of the regulators:
• Operation
• Cleaning
2. INTENDED USE
MEDIFLOW
intended for the administration of the following medical gases in the treat-
ment, management, diagnostic evaluation and care of patients:
• oxygen;
• oxygen-enriched air;
• nitrous oxide;
• medical air;
• synthetic air;
The product is not intended to be use with air or nitrogen for driving
surgical tool.
This low pressure regulator is intended to be fi tted 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 800 kPa.
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Keep away the product and its associated equipment from:
• heat sources (fi re, cigarettes, etc.),
• fl ammable materials,
• oil or grease
• water
• dust
The product and its associated equipment must be prevented from fall-
ing over.
Use only the product and its associated equipment in well vented area.
Always maintain oxygen cleanliness standards.
ULTRA is a low pressure regulator with fl ow-selector device
®
• Maintenance
• Disposal
• carbon dioxide;
• helium;
• xenon;
• specifi ed mixtures of the ga
ses listed above.
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