General Warnings; Technical Specifications - ResMed AirFit N20 Guia Del Usuario

GENERAL WARNINGS

•
The vent holes must be kept clear.
• The mask should only be used with CPAP or bilevel devices recommended by
a physician or respiratory therapist.
•
The mask should not be used unless the device is turned on. Once the mask is
fitted, ensure the device is blowing air. Explanation: CPAP and bilevel devices
are intended to be used with special masks (or connectors) which have vent
holes to allow continuous flow of air out of the mask. When the device is
turned on and functioning properly, new air from the device flushes the
exhaled air out through the mask vent holes. However, when the device is not
operating, insufficient fresh air will be provided through the mask, and the
exhaled air may be rebreathed. Rebreathing of exhaled air for longer than
several minutes can, in some circumstances, lead to suffocation. This applies
to most models of CPAP or bilevel devices.
•
Follow all precautions when using supplemental oxygen.
•
Oxygen flow must be turned off when the CPAP or bilevel device is not
operating, so that unused oxygen does not accumulate within the device
enclosure and create a risk of fire.
•
Oxygen supports combustion. Oxygen must not be used while smoking or in
the presence of an open flame. Only use oxygen in well ventilated rooms.
•
At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration
varies, depending on the pressure settings, patient breathing pattern, mask,
point of application and leak rate. This warning applies to most types of CPAP
or bilevel devices.
•
The technical specifications of the mask are provided for your clinician to
check that they are compatible with the CPAP or bilevel device. If used
outside specification or if used with incompatible devices, the seal and
comfort of the mask may not be effective, optimum therapy may not be
achieved, and leak, or variation in the rate of leak, may affect the CPAP or
bilevel device function.
•
Discontinue using this mask if you have ANY adverse reaction to the use of
the mask, and consult your physician or sleep therapist.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an existing
dental condition. If symptoms occur, consult your physician or dentist.
•
As with all masks, some rebreathing may occur at low CPAP pressures.
•
Refer to your CPAP or bilevel device manual for details on settings and
operational information.
•
Remove all packaging before using the mask.
•
The mask must be used under qualified supervision for users who are unable
to remove the mask by themselves.
•
This mask is not for use on patients with impaired laryngeal reflexes or other
conditions predisposing to aspiration in the event of regurgitation or vomiting.
• Avoid connecting flexible PVC products (eg, PVC tubing) directly to any part of
the mask. Flexible PVC contains elements that can be damaging to the
materials of the mask, and may cause the components to crack or break.
•
The N20 line of nasal CPAP masks are not intended to be used simultaneously
with nebuliser medications that are in the air path of the mask/tube.
•
The mask contains an exhaust port safety feature to enable normal breathing.
The mask should not be worn if this safety feature is damaged or missing.
Note: For any serious incidents that occur in relation to this device, these should
be reported to ResMed and the competent authority in your country.

Technical specifications

Pressure- The mask contains passive venting to protect against rebreathing.
flow curve As a result of manufacturing variations, the vent flow rate may
vary.
5
Pressure Flow
(cm H O) (L/min)
2
4 20
7 27
11 35
14 40
17 44
20 49
24 54
27 58
30 61