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Instructions for Use
ComfortGel Blue SE
intended Use
The ComfortGel Blue SE Nasal Mask is intended to provide an interface for application of CPAP or
bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in
the hospital/institutional environment. The mask is to be used on patients (>30 kg) for whom CPAP
or bi-level therapy has been prescribed.
important note: An exhalation port is not built into the ComfortGel Blue SE Nasal Mask. A
separate exhalation device must be used with this mask.
symbols
Warning or
Caution
Does not contain
natural rubber latex
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.
•
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.
•
This product may contain chemcials (phthalates) which may cause adverse health effects. If you
are pregnant or breast feeding, contact your healthcare professional before use.
•
Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue
use and contact your healthcare professional.
•
At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate to clear
all exhaled gas from the tubing. Some rebreathing may occur.
•
After attaching an additional exhalation device to the patient circuit, you will need to adjust the
pressure level to compensate for the additional leak of the exhalation device.
•
The gel mask is not customizable. Do not attempt to heat.
•
Hand wash prior to first use. Inspect the mask for damage or wear (cracking ,crazing, tears,
cushion damage resulting in gel exposure, etc). Discard and replace any components as
necessary.
Note
Tip
Does not contain DEHP
(bis (2-ethylhexyl)phthalate)
Consult instruc-
tions for use
Contains PHT
(phthalates)
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