Intended Use - GCE MMR Gebrauchsanweisung

ENGLISH
INSTRUCTION FOR USE: MMR PRESSURE REGULATORS
1. FOREWORD
EN
GCE Medical Regulators are medical devices classified as class IIb accord-
ing to the Medical Device Directive 93/42/EEC.Their Compliance with essen-
tial requirements of 93/42/EEC Medical Device Directive is based upon ISO
10524-1 standard.

2. INTENDED USE

GCE Medical Regulators are designed for use with high-pressure medical gas
cylinders equipped with a medical cylinder shut-off valve and in pipeline sys-
tems. They regulate pressure and flow of medical gases to the patient. They
are intended for the administration of the following medical gases in the treat-
ment, management, diagnostic evaluation and care of the patient.
Basic variants (divided by gas type):
• oxygen;
• xenon;
• nitrous oxide;
• specified mixtures of the gases listed;
• air for breathing;
• air to power surgical tools;
• helium;
• nitrogen to power surgical tools;
• carbon dioxide
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Keep the product and its associated equipment from:
• heat sources (fire, cigarettes,...),
• flammable materials,
• oil or grease (especially be careful in use of hand cream),
• water,
• dust.
The product and its associated equipments must be prevented from falling
over.
Always maintain oxygen cleanliness standards.
Use the product and its associated equipment in well ventilated areas only.
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