Intended Use - GCE MEDIEJECT II Mode D'emploi

ENGLISH
INSTRUCTION FOR USE: MEDIEJECT II
1. FOREWORD
GCE medical suction ejectors 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 De-
vice Directive is based upon standards EN ISO 10079-3 and EN 1789, as
amended.

2. INTENDED USE

MediEject II is a medical device designed to generate continuous vacuum
with continuous regulation. It is an ejector that works on the principle of
Venturi effect. The propellant is compressed air or oxygen. The device is
connected in a system with a collecting container or with multiple contain-
ers and a filter connected by suction hoses.
The system may be fixed or portable for use inside healthcare facilities and
also in an ambulance.
The product is not intended for use during thoracic drainage.
The suitability for a specific procedure shall be decided by appropriately
qualified medical staff.
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Keep the product and its associated equipment away from:
• All sources of heat
• Flammable materials
• Oil or grease (including all hand creams)
• Water
• Dust.
The product and its associated equipment must be prevented from tip-
ping over and falling.
Always maintain oxygen cleanliness standards.
Use only the product and its associated equipment in a well ventilated
area.
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EN