INSTRUCTIONS FOR USE
I U
e ComfortGel Custom Nasal Mask and Headgear are
intended for use by adults as an interface with Respironics
CPAP or bi-level devices. e mask contains an exhalation
port and does not require the use of a separate exhalation
device.
I
e ComfortGel mask is designed to t comfortably on most
adults. However, because of dierences in facial features,
some users need a customized t. You can customize this
mask by re-forming the gel to t your face.
• is CPAP mask should be used only with CPAP
systems recommended by your physician or
respiratory therapist. A mask should not be used
unless the CPAP system is turned on and operating
properly. e vent hole or holes associated with the
mask should never be blocked. Explanation of the
Warning: CPAP systems are intended to be used
with special masks 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. Rebreathing of exhaled air for longer
than several minutes can in some circumstances lead
to suocation. is warning applies to most models
of CPAP systems.
• At low CPAP pressures, the ow through the
exhalation port may be inadequate to clear all exhaled
gas from the tubing. Some rebreathing may occur.
• 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. is warning applies to
most CPAP or bi-level systems.
• If oxygen is used with the CPAP or bi-level system,
the oxygen ow must be turned o when the system
is not in operation. Explanation of Warning: When
the CPAP or bi-level system is not in operation and
the oxygen ow is le on, oxygen delivered in the
ventilator tubing may accumulate within the CPAP or
bi-level system enclosure. Oxygen accumulated in the
CPAP or bi-level system will create a risk of re. is
warning applies to most CPAP or bi-level systems.
• Oxygen accelerates res. Keep the CPAP or bi-level
system and oxygen container away from heat, open
ames, any oil substance, or other sources of ignition.
Do not smoke in the area near the device or the
oxygen container.
• Some users may experience skin redness. If this
occurs, consult your healthcare professional.
Covered by the following patents: 5647357,
5884624. Other patents pending.
D P
Dispose of any damaged or broken parts in accordance with local regulations.
C R R
Remove the Gel cushion by detaching the Comfort
Flap® with its integrated retaining ring from the
faceplate. Do this by unhooking the side and bottom
clips of the ring from their connection points on the
faceplate. Clean or discard the cushion if necessary.
Place the cleaned or new Gel cushion into the faceplate.
Place the Comfort Flap over the Gel cushion and push
the retaining ring into the faceplate until you hear a
clicking sound.
1033261
GK 03/08/06
www.comfortseries.respironics.com
M-P U R
L F
W
Custom Nasal Mask & Premium
Headgear with EZPeel™ tabs
1033678 Premium Headgear w/ EZPeel™ tabs
1002801 Deluxe Headgear
1009044 Mask with Premium Headgear, P
1009045 Mask with Premium Headgear, S
1009046 Mask with Premium Headgear, M
1009047 Mask with Premium Headgear, L
1009052 Silicone Flap, P
1009053 Silicone Flap, S
1009054 Silicone Flap, M
1009109 Silicone Flap, L
1018401 Forehead Support and Pad
1009722 Silicone Forehead Pads, 4 pack
1009723 Headgear Swivel Clips, 2 pack
1010646 Diusion Elbow with Exhalation Kit
7041 Mask Swivel
1002720 Split Washer Kit
312710 O
2
Enrichment Attachment
1009048 Cushion, P
1009049 Cushion, S
1009050 Cushion, M
1009051 Cushion, L
CG R N
Visit www.respironics.com for a complete list of products and reorder numbers, or contact Customer
Service at 1-724-387-4000 or +49 (0) 8152 93060 to obtain a product catalog (#1027825).
© 2006 Respironics, Inc. and its aliates. All rights reserved.
Storage: Temperature -20° C to 60° C
Relative Humidity up to 95%, non-condensing
0
0
10
20
30
40
50
60
70
4 8 12 16 20
Pressure vs. Leak Rate for the ComfortGel™
and the Whisper Swivel
®
II
Whisper Swivel II ComfortGel
Exhaust Leak Rate (LPM)
Pressure cm H�0 (hPa)
Pressure Drop cm H2O(hPa)
50 LPM 100 LPM
All Cushion Sizes :
P-S-M-L 0.1 0.25
S e symbol shown below is used on the device.
Attention, consult accompanying documents.
I
Hand wash mask before use.
Deadspace
P 83.6 cc
S 111.4 cc
M 121.3 cc
L 142.6 cc
Exhalation Device
(DO NOT BLOCK)
Premium Headgear
w/ EZPeel™ tabs
Swivel
Connection
Point for Clip
Gel cushion Comfort Flap
with retaining
ring
Clip
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