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Les langues disponibles
Les langues disponibles
s
pecIfIcatIons
Intentional Leak
60.0
60.0
50.0
50.0
40.0
40.0
30.0
30.0
20.0
20.0
10.0
10.0
0.0
0.0
Pressure cm H
O (hpa)
2
Pressure Drop cm H
O (hPa)
2
50 LPM
100 LPM
All mask sizes:
0.4
1.0
Deadspace
Small 260 mL
Medium 280 mL
Large 300 mL
o
s
c
peratIng and
torage
ondItIons
Operating:
+5°C to +40°C
15% to 95% RH, non-condensing
Storage:
-20°C to +60°C
15% to 95% RH, non-condensing
6
I
U
ntended
se
The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level
therapy to patients. For multi-patient use in the home or hospital/institutional environment. The mask is
to be used on patients (>30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or
bi-level system.
An exhalation port is built into the mask so that a separate exhalation port is not required.
This mask is latex free.
General caution or warning
General caution or warning
Consult instructions for use
Consult instructions for use
W
arnIngs
•
The ComfortGel Full face 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.
•
At low CPAP pressures the flow through the exhalation port may be inadequate to clear all exhaled gas
from the tubing. Some rebreathing may occur.
•
If oxygen is used with the CPAP or bi-level device, the oxygen flow must be turned off when the device
is not operating. Explanation of the Warning: When the CPAP or bi-level 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 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, nasal interface selection, and the leak rate.
•
This mask should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to
remove the mask.
•
Contact a health care professional if patient experiences unusual chest discomfort, shortness of breath,
stomach distention, belching, or severe headache when patient awakens or when using this mask.
•
To minimize the risk of vomiting during sleep, the patient should avoid eating or drinking for three hours
before using the mask. This mask is not recommended if the patient is taking a prescription drug that
may cause vomiting.
•
If the patient has respiratory insufficiency, he/she should wear this mask ONLY when therapy is being
delivered.
•
If a nasogastric tube or similar device is in place, use the optional nasogastric tube sealing pad. Position
the pad so that its flat surface is against the patient's face and the C-shaped opening surrounds the tube.
•
Some users may experience skin redness. If this happens, contact your health care professional.
•
Should the barrier of the ComfortGel Full gel cushion rupture or leak, discard immediately. If gel material
comes in contact with the patient's skin, flush with water. If skin irritation or rash occurs, please contact a
heath care professional.
Hand wash mask
Hand wash mask
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