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INSTRUCTIONS FOR USE: MediVitop®
1. FOREWORD
This medical device classified as class IIb complies the General Safety and Performance
Requirements of the Medical Device Regulation (EU) 2017/745 and also comply with
Transportable Pressure Equipment Directive 2010/35/EU and CDG TPE (Amendment) & (EU
Exit) Regulations 2020.
Pressure regulators integrated with cylinder valves (also referred to as "combination valves")
are designed according to EN ISO 10524-3 and EN ISO 10297 standards.
Note: The precautions/warnings specified for oxygen are valid for all gases
(gas specification is stated in Appendix Nr. 1), if not specified differently.
2. INTENDED USE
Medical combination valves MediVitop® are designed to be fitted to gas cylinders used for
medical gases up to 300 bar. These combination valves together with gas cylinders form gas
packages used as gas supply points for medical devices and allow management of the medical
gases and their mixtures supply. Medical combination valves are used to reduce high cylinder
pressure to lower pressure or to specific outlet flow suitable for the administration of medical
gases in the treatment of patients.
MediVitop® combination valve is not intended for use with flammable anaesthetics and
substances.
3. OPERATIONAL, TRANSPORT AND STORAGE SAFETY
REQUIREMENTS
Always maintain oxygen cleanliness standards:
KEEP THE MEDICAL DEVICE AND ITS ASSOCIATED EQUIPMENT AWAY FROM:
Heat sources (fire, cigarettes...),
•
Flammable materials,
•
Oil or grease (take a great care in the use of hand creams),
•
Water,
•
Dust.
•
The medical device and its associated equipment must be prevented from tipping over,
turning over or falling.
Use the medical device and its associated equipment in well ventilated area only. Otherwise
there is a danger of ignition, which can damage and dysfunction the medical device and
endanger the user.
Before the first use the medical device shall be kept in its original package. If removed from
service (for transport, storage) GCE recommends using the original package (including inner
packing materials). National laws, rules and regulations for medical gases, accident prevention
and environmental protection must be observed.
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