Respironics ComfortLite 2 User manual

1067728
JDH 03/30/2010
© 2010 Koninklijke Philips Electronics N.V. All rights reserved. INSTRUCTIONS FOR USE
ComfortLite 2

INSTRUCTIONS FOR USE
1
3 Package Contents
4 Intended Use
5 Warnings
7 Symbols
8 Before Use
8 Cleaning Instructions
9 System One Resistance Control
10 Sizing & Attaching the Cushion
16 Achieving the Right Fit
19 Removing the the Mask from the Headgear
20 Specifications
21 Disposal
22 Limited Warranty
24 Reorder Information
Table of Contents
ComfortLite 2
Nasal Mask

ComfortLite 2
2
ComfortLite 2 Nasal Mask
AB
C
D
E
F
G
H
I
J
K
L
Figure 1
A = Crown Swivel
Connector
B = Top Connection Point
C = Middle Connection
Point
D = Upper Strap
E = Back Strap
F = Lower Strap (behind or
over ears)
G = Front Connection Point
H = Metal Support Band
(Pillows or Direct Seal)
I = Cradle
J = Vertical Tube
K = Vertical Tube
Adjustment
L= Angular Adjustment

INSTRUCTIONS FOR USE
3
Package Contents
ComfortLite 2 nasal interface assembly•
Headgear•
Cushions•
Instructions for use•
Quick fit tips•
NOTE:
Additional accessories
and replacement parts
are available. Please see
the reorder box located
in the back of these
instructions.
Figure 2
Nasal interface assembly,
headgear & cushions

ComfortLite 2
4
Intended Use
The ComfortLite 2 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 Notes:
An exhalation port is built into the ComfortLite 2 Nasal Mask so a•
separate exhalation port is not required
Device pressures should be verified when used by other vendor’s•
auto-titrating devices. ComfortLite 2 has been validated to work with all
Respironics CPAP and bi-level therapy devices.
Caution: U.S. 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 applies to most
models of CPAP systems. Rebreathing of exhaled
air for longer than several minutes can, in some
circumstances, lead to suffocation.
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 an
emphasis on an operating
characteristic.

ComfortLite 2
6
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.
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.
Hand wash prior to first use. Inspect the mask for damage or wear (cracking,•
crazing, tears, etc). Discard and replace any components as necessary.

INSTRUCTIONS FOR USE
7
Symbols
This table defines the symbols used on the ComfortLite 2 mask and/or in
these instructions.
Symbol Description
Warning or Caution
System One Control
Note
Tip

ComfortLite 2
8
Before Use
Hand wash the mask and cushions.•
Read and understand the instructions completely.•
Wash your face.•
Cleaning Instructions
Hand wash the mask before first use and daily.The headgear should be hand
washed weekly, or as needed.The headgear does not need to be removed for
daily cleaning of the mask.
Hand wash the mask and headgear in warm water with a mild liquid dish1.
washing detergent.
Caution: Do not use bleach, alcohol, cleaning solutions containing bleach
or alcohol, or cleaning solutions containing conditioners or moisturizers.
Rinse thoroughly with drinking quality water and air dry out of direct2.
sunlight. Make sure the mask is dry before use. Lay the headgear flat or
line dry. Do not place the headgear into the dryer.
Inspect all parts for damage or wear; replace any parts that have visibly3.
deteriorated (cracking, crazing, tears, etc). Replace the mask if the cushion
becomes hardened.

INSTRUCTIONS FOR USE
9
For multi-patient use in the hospital/institutional environment, use the Mask
Cleaning and Disinfection Instructions to reprocess the mask between patients.
These instructions can be obtained by visiting www.sleepapnea.com or
contacting Customer Service at 1-800-345-6443 (USA or Canada) or
1-724-387-4000.
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.