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instructions for Use
Amara SE Full Face Mask
Intended Use
The Amara SE Full Face Mask is intended to provide a patient interface for application
of noninvasive ventilation. The mask is to be used as an accessory to ventilators which
have adequate alarms and safety systems for ventilation failure, and which are intended
to administer CPAP or positive pressure ventilation for treatment of respiratory failure,
respiratory insufficiency or obstructive sleep apnea. The mask is for multi-patient use in
the hospital/institutional environment only. The mask is to be used on patients (>66 lbs/30
kg) who are appropriate candidates for noninvasive ventilation
Note: An exhalation port is not built into the mask. A separate exhalation device must be used with
this mask.
Note: This mask does not contain natural rubber latex or DEHP.
symbols
Warning
or
Caution
Warnings:
• This mask is not suitable for providing life support ventilation.
• Hand wash prior to use. Inspect the mask for damage or wear (cracking, crazing, tears,
etc). Discard and replace any components as necessary.
• This mask requires a separate exhalation device.
• This mask is designed for use with CPAP or bi-level systems recommended by your health
care professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level
system is turned on and operating properly. Do not block or try to seal the exhalation port.
Explanation of the Warning: CPAP systems are intended to be used with special masks with
connectors which have vent holes to allow continuous flow of air out of the mask. When the
CPAP machine is turned on and functioning properly, new air from the CPAP machine flushes
the exhaled air out through the attached mask exhalation port. However, when the CPAP
machine 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 systems.
• This mask does not include an anti-asphyxia valve that would allow a patient to breathe if the
ventilator failed.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not
operating. Explanation of the Warning: When the device is not in operation, and the oxygen
flow is left on, oxygen delivered into the ventilator tubing may accumulate within the device
enclosure. Oxygen accumulated in the device enclosure will create a risk of fire.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary,
depending on the pressure settings, patient breathing pattern, mask selection, and the leak
rate. This warning applies to most types of CPAP and bi-level machines.
• At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate to
clear all exhaled gas from the tubing. Some rebreathing may occur.
• Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue
use and contact your healthcare professional.
Note
Tip
E n g l i s h
Does Not
Contain
Natural
Rubber Latex
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