Intended Use; Clinical Benefits; Intended Patient Population/Medical Conditions; General Warnings - ResMed NV Elbow F20 Guia Del Usuario

ENGLISH
The NV (Non-Vented) Elbow F20 accessory replaces the existing vented elbow in the AirFit™ F20 /
AirTouch™ F20 mask and converts it to a non-vented mask system.

Intended use

The NV Elbow F20 converts the AirFit F20 and AirTouch F20 Vented Masks into Non-Vented masks
for the purpose of delivering non-invasive positive pressure ventilation. The converted Non-Vented
mask systems are to be used with ventilators that have adequate alarms and safety systems for
ventilator failure, to administer continuous or intermittent ventilatory support.
The NV Elbow F20 (when used with the converted Non-Vented AirFit F20 and Non-Vented AirTouch
F20 masks) is:
• to be used by patients weighing more than 30 kg
intended for single-patient re-use in the home environment and/or multi-patient re-use in the
•
hospital/institutional environment

Clinical benefits

The clinical benefit of non-vented masks is the provision of effective therapy delivery from a therapy
device to the patient.

Intended patient population/medical conditions

Obstructive pulmonary diseases (eg, Chronic Obstructive Pulmonary Disease), restrictive pulmonary
diseases (eg, diseases of the lung parenchyma, diseases of the chest wall, neuromuscular
diseases), central respiratory regulation diseases, and obesity hypoventilation syndrome (OHS).

GENERAL WARNINGS

Refer to the AirFit F20 / AirTouch F20 User Guide for general warnings related to using the
mask. The following additional warnings relate to the use of the NV Elbow F20.
• This mask, fitted with the NV elbow, is to be used with patients requiring non-life support
ventilatory assistance.
• The NV elbow F20 is to be used with ResMed AirFit F20 and AirTouch F20 mask systems
only.
• This mask, fitted with the NV elbow, must be used with an external exhalation device. This
mask must be fitted, and therapy maintained by trained medical staff. Failure to monitor
the patient may result in loss of therapy, serious injury or death.
• This mask, fitted with the NV elbow, must be used under qualified supervision for users
who are unable to remove the mask by themselves or are at risk of not responding to an
issue. This mask is not suitable for individuals predisposed to aspiration. Failure to use
under supervision in these circumstances may result in serious injury or death.
• This mask, fitted with the NV elbow, does not contain an exhaust feature or anti-asphyxia
valve (AAV). This mask must be used with a non-invasive ventilation (NIV) circuit with an
exhaust system or a Positive Pressure Ventilator with an exhalation valve. When the
ventilator is functioning properly, the exhalation valve allows exhaled air to escape to
ambient. When the ventilator is not operating, exhaled air may be re-breathed. Re-
breathing exhaled air can, in some circumstances, lead to suffocation and/or injury.
Non-vented elbow
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