GCE MEDIMETER Gebrauchsanleitung Seite 3

ENGLISH
INSTRUCTIONS FOR USE: MEDIMETER®
1. FOREWORD
GCE Tube Flowmeters are medical devices classifi ed as class IIa according
to the Medical Device Regulation (EU) 2017/745. Compliance with the
General Safety and Performance Requirements of (EU) 2017/745 Medical
Device Regulation is partly based upon EN ISO 15002 standard.
2. INTENDED USE
Tube fl owmeter MEDIMETER is intended to be connected either directly or by
means of fl exible connecting assemblies and disconnected by the operator
• at terminal unit of a medical gas pipeline system
or
• at gas specifi c connection points of devices such as medical pressure
regulator
for accurate fl ow adjustment, fl ow indication and delivery medical gases
directly to a patient under varying conditions of temperature and inlet
pressure.
The gas fl ow is to be supplied via gas outlet under atmospheric pressure to
an open environment, e.g. through a nasal cannula or a facemask.
Tube fl owmeter is not intended to be used with gases for driving surgical
tool.
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Always maintain oxygen cleanliness standards:
Keep the medical device and its associated equipment away from:
• heat sources (fi re, cigarettes, ...),
• fl ammable 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
falling over.
Use only the medical device and its associated equipment in well ventilated
area.
Before initial use the medical device should be kept in its original packaging.
GCE recommends use of the original packaging (including internal sealing
bag and caps) if the medical device is withdraw from operation (for transport,
storage). Statutory laws, rules and regulations for medical gases, accident
prevention and environmental protection must be observed.
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