I
ntended
U
se
The ComfortFull 2 Reusable Full Face Mask and Premium
Headgear are intended for use by adults as an interface with Respironics
CPAP or bi-level devices. The mask covers the nose and mouth. An
exhalation port is built into the ComfortFull 2 mask so that a separate
exhalation port is not required. Before using this mask, the home care
provider should verify device pressure(s). This mask is not suitable for
providing life support ventilation.
d
Isposal
of
p
arts
Dispose of any damaged or broken parts according to local regulations.
• The ComfortFull 2 mask is designed for use with
CPAP and bi-level systems. Do not place the mask
on the patient unless the system is turned on and
operating properly. Do not block or try to seal the
exhalation port. Explanation of Warning: CPAP
and bi-level systems have the potential to allow
rebreathing of exhaled air. These systems are de-
signed for use with masks (or connectors) that have
vent holes or exhalation ports. When the CPAP
or bi-level system is turned on, fresh air from the
system flushes the exhaled air out through the port
holes. If the system is not operating, the exhaled air
may be rebreathed.
• If oxygen is used with this CPAP or bi-level
machine, the oxygen flow must be turned off
when the machine is not operating. Explanation
of 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 machine enclosure. Oxygen accumulated in
the machine enclosure will create a risk of fire. This
warning applies to most types of CPAP and bi-level
machines.
• At a fixed flow rate of supplemental oxygen flow,
the inhaled oxygen concentration will vary, de-
pending on the pressure settings, patient breath-
ing pattern, mask selection, and the leak rate. This
warning applies to most types of CPAP and bi-level
machines.
• 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
the ComfortFull 2 mask.
• To minimize the risk of vomiting during sleep,
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.
• Oxygen accelerates fires. Keep the system and the
oxygen container away from heat, open flames, any
oily substance, or other sources of ignition. Do not
smoke in the area near the CPAP or bi-level system
or the oxygen container.
• Some users experience skin redness. If this happens,
contact a health care professional.
Full Face Mask and Premium Headgear with EZPeel™ tabs
Instructions for Use
Covered by one or more of the following US patents:
Des 464,728 and DES 475,453. Other patents pending.
1033271
GK 03/10/06
MULTI-PATIENT USE REUSABLE
LATEX-FREE
0
10
20
30
40
50
60
70
Pressure vs. Leak Rate
Exhaust Leak Rate (LP
M)
Pressure cm H
2
0 (hPa)
4
8
12
16
20
© 2006 Respironics, Inc. and its affiliates. All rights reserved.
Storage: Temperature -20° C to 60° C
Relative Humidity up to 95%, non-condensing
C
ontraIndICatIons
This mask may not be suitable for persons with the following conditions: impaired cardiac sphincter function,
excessive reflux, impaired cough reflex, and hiatal hernia. It should not be used if the person is
uncooperative, obtunded, unresponsive, or unable to remove the mask.
W
arnIngs
s
ymbol
The symbol shown below is used on the device.
Attention, consult accompanying documents
I
mportant
!
Hand wash mask before use.
www.comfortseries.respironics.com
Deadspace
S 280 cc
M 391.6 cc
L 434.4 cc
Pressure Drop cm H�0(hPa)
50 LPM 100 LPM
All Sizes: S-M-L
0.4
1.0
1033678 Premium Headgear w/ EZPeel™ tabs
1014334 ComfortHeadgear
1004881 ComfortFull 2 w/ Premium Headgear, S
1004873 ComfortFull 2 w/ Premium Headgear, M
1004951 ComfortFull 2 w/ Premium Headgear, L
452040 NG Tube Sealing Pad (10/pack)
1018401 Forehead Support and Pad
1009722 Silicone Forehead Pads, 4 Pack
1009723 Ball-and-Socket Headgear Swivel Clips (2 pk.)
1004871 Entrainment Valve Swivel
1010872 Portcap (5/pack)
ComfortFull 2 Reorder Numbers
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).
H
ome
C
are
p
rovIders
If a nasogastric (NG) tube or similar device is in place, use the optional NG tube sealing pad. Position the pad so
that its flat surface is against the user’s face and the C-shaped opening surrounds the tube.
English
