Philips Amara Mode D'emploi

Instructions for Use
Amara Full Face Mask
Intended Use
The Amara Full Face 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.
Note: An exhalation port is built into the mask so a separate exhalation port is not
required.
Note: This mask is not made with natural rubber latex or DEHP.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or Caution
Not made with
natural rubber latex
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 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.
• 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.
• Consult a physician if any of the following symptoms occur: Unusual chest discomfort,
shortness of breath, stomach distension, belching, severe headache, blurred vision, drying of
the eyes, eye pain or eye infections.
Note
System One
Resistance Control
Setting
Tip
1