PHILIPS Respironics ComfortGel User manual

1067752
JDH 3/3/2010 INSTRUCTIONS FOR USE
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 USA
ComfortGel

Instructions for Use
1
COMFORTGEL
Nasal Mask
2 Package Contents
4 Intended Use
5 Warnings
8 Symbols
9 Before Use
9 Cleaning Instructions
11 System One Resistance Control
12 Removing and Attaching the Headgear
16 Achieving the Right Fit
20 Removing the Headgear and Mask
21 Customizing the ComfortGel Cushion
23 Removing and Attaching the Flap and Integrated Ring
25 Specifications
27 Reorder Information
29 Limited Warranty
Table of Contents

COMFORTGEL
2
Package Contents
ComfortGel nasal mask•
Premium headgear w/ EZPeel tabs•
Mask assembly•
Gel cushion•
Comfort flap•
Instructions for use•
Quick fit tips•
Comfort Guide DVD•
Note: Visit www.respironics.com for a complete list of products
and reorder numbers, or contact Customer Service at
1-800-345-6443 (USA or Canada only) or at 1-724-387-4000 to
obtain a product catalog (REF 1027825).

Instructions for Use
3
A
B
C
D
EF
G
H
Figure 1
A = Forehead Pad
B = Forehead Support
Arm with Stability Selector
C = Exhalation Port - DO
NOT BLOCK
D = Mask Swivel
(Connects to Tubing)
E = Tubing (Connects to
CPAP Device)
F = Quick Clip
G = Gel Cushion &
Comfort Flap
H = EZPeel Tab

COMFORTGEL
4
Intended Use
The ComfortGel 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 (>66lbs/30kg) for whom CPAP or bi-level therapy has
been prescribed.
Important Note: An exhalation port is built into the
ComfortGel Nasal Mask so a separate exhalation port is not
required.
Important Note: The ComfortGel mask is designed to fit
comfortably on most adults. However, because of differences in facial
features, some users need a customized fit. You can customize this mask
by re-forming the gel to fit your face.
Caution: US federal law restricts this device to sale by or on the
order of a physician.

Instructions for Use
5
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. 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
Warning!
A warning indicates the
possibility of injury to the
user or operator.
Caution!
A caution indicates the
possibility of damage to
the device.
Note
A note places emphasis
on an operating
characteristic.

COMFORTGEL
6
applies to most models of CPAP systems. Rebreathing of exhaled air
for longer than several minutes can, in some circumstances, lead to
suffocation.
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.
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.

Instructions for Use
7
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.
Use of a nasal or full face mask may cause tooth, gum, or jaw soreness or•
aggravate an existing dental condition. Consult your physician or dentist
if symptoms occur.
If an additional exhalation device is added to the patient circuit, you may•
need to adjust the pressure level to compensate for the additional leak
of the exhalation device.
Disposal
Dispose of in accordance with local regulations

COMFORTGEL
8
Symbols
Symbol Description Symbol Description
Warning or
Caution
Does not contain
natural rubber
latex
Note
Does not contain
DEHP
(bis (2-ethylhexyl)
phthalate)
.
Tip
System One
Resistance
Control Setting
Consult
instructions
for use
Prescription
required

Instructions for Use
9
Before Use
Hand wash mask.•
Read and understand the instructions completely.•
Remove protective coverings.•
Wash face.•
Remove the quick fit tips.•
If the wearer has sensitive skin, condition the mask cushion and forehead pad
before use. To condition, create a bath of warm, soapy water and soak the cush-
ion and pad for 30-60 minutes. Use a mild liquid detergent free of conditioners,
moisturizers, or bleaching agents. Rinse thoroughly and air dry.
Cleaning Instructions
For Multi-Patient Use:Visit www.respironics.com or contact
Respironics Customer Service at 1-800-345-6443 (USA or Canada
only) or at 1-724-387-4000 to obtain Mask Disinfection Instructions
(REF 1011138).
For Home Use: The mask and tubing should be cleaned daily.

COMFORTGEL
10
Cleaning the Mask
Note: It is not necessary to disconnect the headgear for daily use
and cleaning.
1. Hand wash mask in warm water with a mild
dishwashing detergent.
Caution: Do not use bleach, alcohol, or cleaning solutions
containing bleach or alcohol, or cleaning solutions containing
conditioners or moisturizers.
2. Rinse thoroughly. Pat with a towel and air dry completely
before use.
3. Inspect all parts for damage or wear; replace any parts that have
visibly deteriorated (cracking, crazing, tears, etc). Replace the mask
if the cushion becomes hardened.
Cleaning the Headgear
The headgear should be cleaned weekly by hand or machine wash in
the gentle cycle. Lay the headgear flat or line dry. Do not place the
headgear into the dryer.

Instructions for Use
11
System One Resistance Control
This mask uses the System One Resistance Control setting .
This symbol may appear on your therapy device. This symbol
represents the level of mask resistance compensation. Match the
setting to the mask if appropriate.
Important Notes:
Verify the System One setting if the mask or mask cushion•
changes.
The System One setting is not compatible with masks requiring a•
separate/additional exhalation device.
If your provider has locked the resistance compensation setting,
you can view the setting but cannot change it, and the screen will
display a lock symbol. If your provider has disabled the resistance
compensation, you will not see this setting.

COMFORTGEL
12
Removing and Attaching
the Headgear
Please use one of the following methods to
remove the headgear from the mask.
Method 1
Undo the EZPeel tabs (Figure 2) on the
headgear and pull them through the slots in the
forehead support and through the slots on the
Quick Clips.
To reattach the headgear to the forehead
support arm, thread the top headgear straps
through the slots in the forehead support and
through the slots on the Quick Clips. Fold the
EZPeel tabs to latch onto the headgear straps.
A
B
Figure 2
A = Forehead Pad Slot
B= EZPeel Tab

Instructions for Use
13
Figure 3
Disconnect Quick Clips
Figure 4
Press Center Tab —Squeeze ribbed sides of the support
arm to engage and disengage.
Method 2
Disconnect the Quick Clips and Forehead
Support Arm from the Forehead Support.
Pull the Quick Clip ball up and away from the
socket (Figure 3).
Do not pull the ball through the socket.
Press in on the center tab of the forehead
support (Figure 4) and then squeeze the upper
sides of the support arm together to disengage
or re-engage the forehead support pad.

COMFORTGEL
14
Attach the Quick Clips to the mask by placing the ball against the
socket and gently pressing into place.Then connect the forehead
support arm by pressing in on the center of the forehead support pad
and then squeezing the upper sides of the support arm together and
sliding the tabs into the forehead support pad until they latch
into place.

Instructions for Use
15
Figure 5
Areas of the Face
A = Sides of nostrils
B = Bridge of nose zone
C = Below the nose tip,
above the lip
A
B
C
Getting the Right Cushion Size
Identify the areas of the face (Figure 5) A)sides of the nostrils, B)bridge
of the nose, and C)below the nose tip and above the lip. Use the sizing
gauge integrated into the product bag to get the right size cushion.
Choose the smallest size mask cushion that is wide enough to extend
beyond the nostrils but does not obstruct breathing.

COMFORTGEL
16
Achieving the Right Fit
1. Open the headgear to a large setting and
adjust the forehead arm (Figure 6) to the
highest position. To adjust, gently squeeze
the arms of the StabilitySelector and slide
the arm upwards.
To make it easier to place the mask and
headgear, we recommend disconnecting
one of the Quick Clips.
2. Put on the mask (Figure 7). Simply hold
the mask cushion gently over nose and
pull the headgear on over head.Then
reconnect the Quick Clip when the
headgear and mask is on.
3. Adjust the top (Figure 8) headgear strap
first by using the EZPeel tabs on the
headgear.The forehead pad should be
touching the forehead lightly. Adjust the
Figure 6
Adjust the forehead arm
to the highest position.
Figure 7
Put on the mask.

Instructions for Use
17
bottom strap so that the mask is sitting
gently on the face.
4. Connect the flexible tubing (Figure 9)
(included with the CPAP or bi-level
device) to the swivel on the mask elbow.
5. Turn on the airflow.
6. Lie down (Figure 10) and breathe
normally through nose, keeping lips closed.
If the forehead support does not rest
comfortably against the forehead, tighten
the top headgear strap on the mask.
Figure 8
Adjust the top strap.
Figure 9
Connect the flexible
tubing to the mask swivel.
The mask swivel connects
to the mask elbow.

COMFORTGEL
18
Figure 10
Lie down—Breathe
normally with lips closed.
Troubleshooting Leaks
Adjust the forehead support arm to reduce
leaks or reduce pressure points at the bridge
or above the lip. Follow these tips to adjust
for leaks:
For leaks around the bridge of the nose•
or into the eyes gently squeeze the arms
of the StabilitySelector and adjust to a
lower position.
For leaks under the nose or near the lip•
Figure 11
Troubleshooting—Adjust
the StabilitySelector to
lessen leaks.

Instructions for Use
19
gently squeeze the arms of the StabilitySelector and adjust to a
higher position.
Reseat the mask by pulling it directly away from the face and gently•
setting it back into place.
Comfort Tip:
If not able to minimize the air leaks and obtain a comfortable fit,
follow the directions for Customizing the ComfortGel Cushion.