Philips Amara View - Amara View Mask Introduction and Safety; Intended Use; Warnings

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Amara View minimal contact full-face mask
Instructions for Use - English
Intended Use
This mask is intended to provide an interface for application of CPAP or bi-level
therapy to patients. The mask is for single patient use in the home or multi-patient
use in the hospital/institutional environment. The mask is to be used on patients
(>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
Caution: U.S. Federal law restricts this device to sale by or on the order of a
physician.
Note:
• An exhalation port is built into this mask so a separate exhalation port is not required.
• This mask is not made with natural rubber latex or DEHP.
Symbols
Warning or Caution Note
Tip
Consult Instructions for
Use
Not Made with Natural
Rubber Latex
X1 System One Resistance Control
Warnings
• This mask is not suitable for providing life support ventilation.
• 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. This warning applies to most models of CPAP
systems.
• 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.