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60822r2.book Page 1 Wednesday, August 6, 2003 9:10 AM
The U
M
F
F
LTRA
IRAGE™
ULL
ACE
accessory to a non-continuous ventilator
(respirator) intended for multipatient use
for adult patients prescribed continuous
positive airway pressure (CPAP) and bilevel
therapy in hospital, clinic and home
environments.
M
I
EDICAL
NFORMATION
Note: The mask system does not contain
latex materials. If you have ANY reaction to
any part of the mask system, discontinue use
and consult your sleep therapist.
C
ONTRAINDICATION
For patients who are unable to remove the
U
M
F
F
M
LTRA
IRAGE
ULL
ACE
ASK
used under qualified supervision.
W
ARNINGS
This mask should be used only with
•
CPAP or bilevel systems recommended
by your physician or respiratory
therapist. A mask should not be used
unless the CPAP or bilevel system is
turned on and operating properly. The
exhalation device should never be
blocked.
Explanation of the Warning: CPAP or
bilevel systems are intended to be used
with special masks with connectors
which have vent holes or separate
exhalation devices to allow continuous
Ultra Mirage
™
M
is an
flow of air out of the mask. When the
ASK
CPAP or bilevel device is turned on and
functioning properly, new air from the
flow generator flushes the exhaled air
out through the attached mask
exhalation port. However, when the
CPAP or bilevel device is not operating,
enough fresh air will not be provided
through the mask, and exhaled air may
be rebreathed. Rebreathing of exhaled
air for longer than several minutes can in
some circumstances lead to suffocation.
This warning applies to most models of
CPAP or bilevel systems.
The exhaust vent flow is lower at lower
•
mask pressures (see Pressure/Flow
Curve - Figure A). If the mask pressure
, it must be
during expiration is too low, there may
not be enough exhaust vent flow to
completely flush the air delivery hose of
exhaled air before the start of the next
inspiration. The possibility of rebreathing
should be assessed in patients with
prescribed expiratory pressures below
4 cmH
O.
2
The mask should not be worn if the
•
anti-asphyxia valve membrane is
damaged or missing. If the valve
membrane is damaged, distorted or
torn, it should be replaced with a new
valve membrane.
The mask may not be suitable for those
•
at increased risk of gastric regurgitation.
Full Face Mask