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AF811 Gel Full Face Mask
Intended Use
The AF811 Gel Full Face Mask is intended to provide an interface for application of CPAP
or bi-level therapy to patients. The mask is for single use in the hospital/institutional
environment only. 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 not built into the AF811 Gel Full Face Mask. A separate
exhalation device must be used with this mask.
Note
: This mask does not contain natural rubber latex or DEHP.
Caution
: U. S. federal law restricts this device to sale by or on the order of a physician.
Symbols
Warnings:
•
This mask is not suitable for providing life support ventilation.
•
This mask requires a separate exhalation device.
•
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. This warning applies to most models of CPAP systems. Rebreathing of
exhaled air for longer than several minutes can, in some circumstances, lead to suffocation.
•
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.
•
Oxygen supports combustion. Oxygen should not be used while smoking or in the presence
of an open flame.
•
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.
•
Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue
use and contact your healthcare professional.
•
The patient’s physician should be contacted if the patient experiences the following
symptoms while using the masks or after removing it: Unusual chest discomfort, shortness
of breath, stomach distension, belching, or severe headache; drying of the eyes, eye pain, or
eye infections; blurred vision. (Consult an ophthalmologist if
symptoms persist.)
•
At low CPAP or EPAP pressures the flow through the exhalation
Warning or
Caution
Note
Consult instructions
for use
Does not contain
natural rubber latex
Do Not
Reuse
Leak symbol
and value
ENGLISH
Instructions for Use
