Intended Use - PHILIPS Respironics ComfortGel Blue Full Manual

Instructions for Use
ComfortGel Blue Full Face Mask

Intended Use

The ComfortGel Blue Full Face 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
(>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
Note: An exhalation port is built into the ComfortGel Blue Full Face Mask so a separate
exhalation port is not required.
Note: This mask does not contain natural rubber latex or DEHP.
Symbols
Warning or
Caution
Does not contain
natural rubber latex
Warnings:
This mask is not suitable for providing life support ventilation.
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.
Explanation of the Warning:
with connectors which have vent holes to allow continuous ow of air out of the mask. When
the CPAP machine is turned on and functioning properly, new air from the CPAP machine
ushes 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 ow must be turned o when the device is not
operating. Explanation of the Warning:
oxygen ow 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 re.
Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of
an open ame.
At a xed ow rate of supplemental oxygen ow, 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 mask 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 ow through the exhalation port may be inadequate to clear
all exhaled gas from the tubing. Some rebreathing may occur.
A minimum of 3cm H
This mask should not be used for patients who are uncooperative, obtunded, unresponsive, or
unable to remove the mask.
This mask is not recommended for patients who are taking a prescription drug that may
cause vomiting.
Tip
Note
System One Resistance
Control Setting
Do not block or try to seal the exhalation port.
CPAP systems are intended to be used with special masks
O (hPa) must be maintained when using this mask.
2
Consult instructions
for use
When the device is not in operation, and the
E N G L I S H
1