Intended Use; General Warnings - ResMed NV Elbow F20 User Manual

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

Intended use

The NV (Non-Vented) Elbow F20 converts the AirFit F20 into a non-invasive mask used for
channeling airflow (with or without supplemental oxygen), intended to be used with active-
exhaust-valve ventilators, to provide ventilatory assistance to patients with respiratory
insufficiency and respiratory failure.
The NV Elbow F20 (when used with the AirFit F20 mask) is:
• to be used by patients weighing >66 lb (30 kg) requiring non-life support ventilatory
assistance.
• intended for single-patient reuse in the home and hospital/institutional environment.

GENERAL WARNINGS

Refer to the AirFit F20 User Guide for additional warnings related to using the mask. The
following warnings relate to the use of the NV Elbow F20.
• The NV Elbow F20 does not contain an exhaust vent or safety valve. The non-vented
elbow must be used with breathing circuits or PPV devices which provide their own
method of venting expired or supplemental gases.
• The mask must be used under qualified supervision for users who are unable to
remove the mask by themselves or when the patient is at risk of not responding to
severe hypoxia or hypercapnia by arousal. The mask may not be suitable for those
predisposed to aspiration.
• The mask should only be used with ventilators recommended by a physician or
respiratory therapist.
• The mask should not be worn unless the ventilator system is turned on and
operating properly.
• The technical specifications of the mask are provided for your clinician to check
that they are compatible with the ventilator. 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 ventilator function.
• Visible criteria for product inspection: If any visible deterioration of a system
component is apparent (cracking, discoloration, tears, etc.), the component should
be discarded and replaced.
Note: Any serious incidents that occur in relation to this device should be reported to ResMed
and to the competent authority in your country
Using the elbow
ResMed has tinted the NV Elbow F20 blue to identify it as a non-vented accessory. The elbow
has a standard female 22mm tapered fitting for external connection to the ventilator. Refer to
the Technical specifications section in this user guide for information about mask leak, dead
space and resistance.
Assembly
1. If the vented elbow is still assembled to the mask, squeeze the side buttons and pull the
elbow away from the frame.
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