M
IRAGE
The M
V
™ nasal mask is
®
IRAGE
ISTA
intended for adult patients prescribed
continuous positive airway pressure
(CPAP) and bilevel therapy in hospital,
clinic, and/or home environments.
CAUTION
In the USA, federal law restricts this
device to sale by, or on the order
of, a physician.
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.
WARNINGS
•
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 and bilevel systems are
intended to be used with special
masks with connectors which have
vent holes or separate exhalation
devices to allow continuous flow
of air out of the mask. When the
CPAP or bilevel machine is turned
on and functioning properly, new
air from the machine flushes the
exhaled air out through the
attached mask exhalation port.
However, when the CPAP or
bilevel machine is not operating,
enough fresh air will not be
provided through the mask, and
V
ISTA
™
®
M
ASK
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 and bilevel
systems.
The M
V
•
features an
IRAGE
ISTA
elbow that can be easily removed
while the mask is fitted. The mask
should not be used with the elbow
attached unless the CPAP or
bilevel system is turned on and
operating properly.
•
If oxygen is used with this CPAP or
bilevel machine, the oxygen flow
must be turned off when the
CPAP or bilevel machine is not
operating.
•
Please refrain from smoking while
oxygen is in use.
Explanation of the Warnings:
When the CPAP or bilevel device
is not in operation, and the
oxygen flow is left on, oxygen
delivered into the ventilator tubing
may accumulate within the CPAP
or bilevel machine enclosure.
Oxygen accumulated in the CPAP
or bilevel machine enclosure will
create a risk of fire. This warning
applies to most types of CPAP or
bilevel machines.
Note: At a fixed rate of supplemental
oxygen flow, the inhaled oxygen
concentration will vary, depending on
the pressure settings, patient breathing
pattern, mask selection, and leak rate.
CAUTION
At low CPAP pressures, the flow
through the exhalation port may be
inadequate to clear all exhaled gas
from the tubing. Some rebreathing
may occur.