Regulators IFU GB,FR,DE,NL Rev 03
Page 2/44
12/02/2010
1. Foreword
GCE Medical Regulators are medical devices classified as class IIb according to the
Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical Device Directive is
based upon EN 10524-1 standard.
2. Intended use
GCE Medical Regulators are designed for use with high-pressure medical gas cylinders
equipped with a medical cylinder valve. They regulate pressure and flow of medical
gases to the patient. They are intended for the administration of the following medical
gases in the treatment, management, diagnostic evaluation and care of the patient:
- oxygen;
- nitrous oxide;
- air for breathing;
- helium;
- carbon dioxide;
- xenon;
- specified mixtures of the gases listed.
- air or nitrogen to power surgical tools.
3. Operational, transport and storage safety requirements
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Keep the product and its associated equipments away from
- heat sources (fire, cigarettes, …),
- flammable materials,
- oil or grease, (especially be carefull if hand cream is
used)
- water,
- dust.
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The product and its associated equipments must be prevented
from falling over.
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Always maintain oxygen cleanliness standards.
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Use only the product and its associated equipments in well
ventilated area.
Before initial use the product should be kept in its original packaging. GCE recommends
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.
