Sleepnet Aura Mode D'emploi page 6

ENGLISH
!
The Aura Nasal Vented Mask is intended to provide an interface for application of positive airway pressure therapy,
such as Continuous Positive Airway Pressure (CPAP) or bi-level. The mask is intended for single patient, multi-use in
the home, hospital, or institutional environment on adult patients (>66lbs/30kg) for whom CPAP or bi-level therapy has
been prescribed.
h The mask system does not contain DEHP or phthalates. If the patient has ANY reaction to any part of
the mask system, discontinue use.
h This product is not manufactured with natural rubber latex.
h An exhalation port is built into this mask so a separate exhalation port is not required.
h In the U.S., Federal Law restricts this device for sale by or on the order of a physician.
h Do not expose the mask to temperatures above 122˚F (50˚C).
h The mask may be cleaned and used repeatedly on the same person. Do not sterilize or disinfect.
h This mask is not suitable for providing life support ventilation.
h At low pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas from
the tubing. Some rebreathing may occur.
h Do not use this mask with baseline pressure less than 4 cm H
h This mask should be used with the positive airway pressure device recommended by a physician or
respiratory therapist.
h Do not block or try to seal the vent holes or non-rebreathing valve. The vent holes allow a continuous
flow of air out of the mask.
h The mask should not be used unless the positive airway pressure device is turned on and operating
properly. Explanation of the warning: When the positive airway pressure device is turned on and
functioning properly, new air from the device flushes the exhaled air out through the mask's vent holes.
When the positive airway pressure device is not operating, exhaled air may be rebreathed. Rebreathing of
exhaled air can, in some circumstances, lead to suffocation. This warning applies to most models of
CPAP machines and masks.
h If oxygen is used with this CPAP mask, the oxygen flow must be turned off when the CPAP machine is
not operating. Explanation of the warning: When the CPAP device is not in operation, and the oxygen
flow is left on, oxygen delivered into the device tubing may accumulate within the CPAP machine
enclosure. Oxygen accumulated in the CPAP machine enclosure will create a risk of fire.
h At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will vary, depending on
pressure settings, patient breathing, and leak rate.
h No smoking or open flames such as candles may be used when oxygen is in use.
h Any unusual skin irritation, chest discomfort, shortness of breath, gastric distension, abdominal pain,
belching or flatulence from ingested air, or severe headache experienced during or immediately after use
should be reported to a healthcare professional.
h Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If
symptoms occur, consult a physician or dentist.
h Consult a physician if you experience any of the following symptoms while using the mask: Drying of
the eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if symptoms persist.
Do not overtighten the headgear straps. Signs of overtightening include: excessive redness, sores, or
h
bulging skin around the edges of the mask. Loosen headgear straps to alleviate symptoms.
h Significant unintentional leak may occur without properly fitting the mask.
This mask has a non-transferable three month limited warranty for manufacturer's defects from the date of purchase
by the initial consumer. If a mask used under normal conditions should fail, Sleepnet will replace the mask or its
components. For additional information about the Sleepnet Warranty, please visit http://www.sleepnetmasks.com/. Per
EU MDR 2017/745, please report serious incidents to manufacturer and EU Member State competent authority.
NOTE: The mask has a service life of 6 months.
NOTE: Please dispose of the mask and accessories in accordance with local and regional guidelines.
6
Aura Nasal Vented Mask
®
®
Contents: Aura Nasal Vented Mask with headgear
Rx only
Made in the U.S.A of U.S. and imported parts
NOTES
CAUTIONS
WARNINGS
GENERAL INFORMATION
O.
2