Intended Use - gce mediline SABRE ELITE Série Mode D'emploi

FOREWORD
1.
GCE SABRE ELITE
to the Medical Device Directive 93/42/EEC and Transportable Pressure
Equipment Directive 99/36/EEC.
Its compliance with the essential requirements 93/42/EEC Medical Device
Directive is based upon EN ISO 10524-3 standard.
2.

InTEnDED USE

The innovative ELITE oxygen conserving device conserves oxygen,
and thus prolongs the service life of the cylinder. Elite also increases the
mobility of the patient. Thanks to the system's precision metering, the O
cylinders last approximately three-times longer than with simple pressure
regulators without conserving system, without any loss of therapeutic
effect.
ELITE offers major advantages:
•
Ease of handling. Just screw a pressure regulator onto the cylinder,
turn the cylinder on, adjust the flow rate at the rotary switch and your
ready to go.
•
No batteries required. You can save money, and potential sources of
error are removed.
•
The special rotatable pressure gauge can be read easily from all
angles.
•
No expensive special masks needed. Wear your normal standard nose
mask.
•
The light weight, ease of handling and robust design offer the patients
optimum suitability for everyday use and maximum comfort
ELITE is delivered with a strapped carry bag Cylinder and Nasal Cannula.
Operational, transport and storage safety requirements
OPERATIOnAL, TRAnSPORT AnD STORAgE
3.
SAFETy REqUIREMEnTS
Keep the product and its associated equipment away from:
•
heat sources (fire, cigarettes,...),
•
flammable materials,
•
oil or grease (be careful in the use of tissues and creams),
•
water,
•
dust.
Do not drop or let the product falling down.
Always maintain oxygen cleanliness standards.
is medical device classified as class II b according
®
3/72
gB
2