®
MIRAGE
NV FULL FACE
MASK SERIES 2
The M
®
NV F
IRAGE
ULL
vented) is only indicated for the treatment of adult
patients using non-invasive ventilator systems that have
an active exhaust.
P
RECAUTION
In the USA, federal law restricts this device to sale by,
or on the order of, a physician.
C
ONTRAINDICATIONS
•
The M
NV F
IRAGE
be used without appropriately qualified supervision
either when the patient is at risk of not responding
to severe hypoxia or hypercapnia by arousal, or
when the patient, having aroused, is unable to
remove the mask.
W
ARNINGS
•
The mask must not be used on patients with
impaired laryngeal reflexes or other conditions
predisposing to aspiration in the event of
regurgitation or vomiting.
2
F
M
S
2 system (non-
ACE
ASK
ERIES
F
M
S
2 must not
ULL
ACE
ASK
ERIES
•
The mask should not be worn unless the ventilator
system is turned on and operating properly.
•
At a fixed rate of supplemental oxygen flow (if
used), the inhaled oxygen concentration will vary
depending on the pressure settings, patient
breathing pattern, mask selection, and the leak rate.
•
The mask must not be used if the patient is known
to be allergic to any of the following mask
component materials: polycarbonate, silicone
rubber, polyurethane rubber, nylon, polyester, and
cotton.
P
RECAUTIONS
•
The mask is not for use with ventilators which have
a combination of:
a) little or no ability to compensate for mask leak
and variation in mask leak (eg volume-cycled
ventilators with no compensation for leak, or
pressure-cycled ventilators which are unable to
deliver adequate extra flow in the presence of
increased leak); and