Respironics ComfortLite 2 Instructions For Use Manual

1067728

JDH 03/30/2010

© 2010 Konink lijke Ph ilips El ectro nics N.V. All ri ghts re serve d.

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

A

B

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 dish 1.
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 direct 2.
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 visibly 3.
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.

ComfortLite 2

10

Direct Seal Pillows Simple

Size 1 X2 P X4 P X1

Size 2 X2 S X4 S X1

Size 3 X2 M X2 M X1

Size 4 X1 L X1 L X1

Size 5 X2

Size 6 X2

Sizing & Attaching the Cushion

The ComfortLite 2 may come with an assortment
of nasal interface cushions in multiple sizes (Figure 3).

A

B C

Figure 3

Cushion assortment

A = Pillows Cushion
B = Simple Cushion
C = Direct Seal Cushion

INSTRUCTIONS FOR USE

11

Figure 4a

Pillows cushion

A = Elbow
B = Pillows
C = Exhalation Vent

(Do not block)

D = Metal Support

A

B

C

D

Sizing the Pillows Cushion

To determine the proper size, (Figure 4a) select the
Pillows cushion that fills the nostrils without any gaps
between the cushion and the nostril walls
(Figure 4b & c).

Figure 4b

Correct fit:
Pillows inside
nostrils

Figure 4c

Incorrect fit:
Pillows outside nostrils

ComfortLite 2

12

Sizing the Simple Cushion

To determine the proper size, start
with the smallest Simple cushion in the
package. Choose the size that fits over the
entire nose without blocking the nostrils
(Figure 5b & c).

Slide the smaller opening of the Simple
cushion over the ball and socket connector
(Figure 5a).

Tip: Position the Simple cushion so the
narrower end fits over the bridge of the nose
and the wider end is under the nostrils.

A

B

C

D

Figure 5a

Simple cushion

A = Simple Cushion
B = Ball & Socket

Connector

C = Exhalation vent

(Do not block)

D = Elbow

Figure 5b

Correct fit ­cushion fits over
the nose

Figure 5c

Incorrect fit

- cushion is
placed too high
& blocks the
nostrils

INSTRUCTIONS FOR USE

13

Comfort Tips

The Simple cushion should cover but not •
obstruct the nostrils.

Pivot the Simple cushion to angle it to your •
features and to correct leaks.

Sizing the Direct Seal Cushion

To determine the correct size, start with the largest
Direct Seal cushion (Figure 6a) in the package. The
bulbs of the Direct Seal cushion should rest on the
edge of the nostrils, blocking the ends (Figure 6b).

The bulbs should not be inserted into the nostrils
(Figure 6c). Therefore, choose a cushion with bulbs
larger than your nostrils.

Figure 6a

Direct Seal cushion

A = Direct Seal Bulb
B = Metal Support
C = Exhalation Vent

(Do not block)

D = Elbow

A

B

C

D

ComfortLite 2

14

Figure 6c

Incorrect fit - bulbs
inside the nostrils

Figure 6b

Correct fit - bulbs
rest against the
nostrils

INSTRUCTIONS FOR USE

15

Attaching the Cushion to the Vertical Tube

After you have chosen the proper cushion size and
type, align the vertical tube knob with the notch in
the rim of the exhalation elbow (Simple cushion) or
cradle (Pillows & Direct Seal cushions). Slide the two
pieces together and turn the cushion until it clicks
into place (Figure 7).

Figure 7

Connecting the
cushion to the
vertical tube

A = Vertical Tube

Knob
B = Vertical Tube
C = Exhalation Elbow

A

B

C

ComfortLite 2

16

Achieving the Right Fit

The headgear and mask only require a one-time
sizing and fitting.

Place the headgear against your forehead and 1.
pull the straps over your head (Figure 8a).

Tighten the lower strap to provide a firm yet 2.
comfortable level of stability. The bottom edge
of the headgear should rest just above the
eyebrows (Figure 8b). The back strap of the
headgear should be pulled down toward the
back of the neck for maximum support. The
straps can be worn behind or over the ears.

Adjust the upper strap (if necessary) to 3.
improve the fit of the headgear over the top of
the head. Do not over-tighten the upper strap.
Over-tightening may cause the headgear to
rise off of the head.

Note: If the headgear slides on your head or
irritates your ears, move the upper strap to a
different (upper or middle) connection point.

Figure 8a

Pull the straps over
your head

Figure 8b

Proper position of mask
on head

INSTRUCTIONS FOR USE

17

To do this, simply unfasten the hook and loop
tab, pull the strap through the connection
point, and refasten.

Note: Make sure the front of the headgear
rests on the brow line.

Comfort Tip: Wear the backstrap under your
hair if it is long or silky..

To move the cushion closer to or farther from 4.
your face, squeeze the tabs on the angular
adjustment and pull them outward or inward
(Figure 9).

To move the cushion up or down, twist the 5.
dial on the vertical tube adjustment until the
cushion is at the proper height (Figure 10).

Bend the metal support band to adjust the 6.
Pillows or Direct Seal bulbs to the width of
your nostrils (Figure 11).

Note: Do not squeeze the metal band on the
Pillows and Direct Seal cushions to move the
cushion up or down; always use the angular
and/or vertical tube adjustment.

Figure 9

Angular adjustment

Figure 10

Vertical tube adjustment

ComfortLite 2

18

Connect the tubing of the CPAP or bi-7.
level device to the crown swivel connector
(Figure 12). Turn on the device and adjust the
ComfortLite 2 to correct any leaks.

Troubleshooting Leaks

Try a different size cushion. •
Use the angular and vertical tube adjusters to •

change the cushion position.
Tighten or loosen the headgear. •
If you are using the Simple Cushion, verify that it •

is properly connected to the exhalation elbow.
Verify that the front of the headgear rests on •

the brow line (Figure 8b,).

Figure 11

Metal support band
adjustment

Figure 12

Connect the
ComfortLite 2 to the
CPAP or bi-level device

A = Device Tubing
B = Crown Swivel

Connector

A

B

INSTRUCTIONS FOR USE

19

Removing the Mask from the
Headgear

First, unfasten the white retaining strap from the
crown swivel. Squeeze the clear tabs behind the
angular adjuster (Figure 13) and slide them up
and off the track. This will completely remove the
assembly from the headgear.

Figure 13

Headgear removal

A = Crown Swivel
B = White Retaining Strap

A

B

ComfortLite 2

20

Specications

Warning: The technical specifications of the mask are provided for your

healthcare professional to determine if it is compatible with your CPAP
or bi-level therapy device. If used outside these specifications, or if used
with incompatible devices, the mask may be uncomfortable, the seal of
the mask may not be effective, optimum therapy may not be achieved,
and leak, or variation in the rate of leak, may affect device function.

Intentional Leak

Exhaust Leak Rate (SLPM)

0

10

20

30

40

50

60

Whisper Swivel II

Simple

Pillows/Direct Seal

3020161284

Pressure cm H2O (hPa)

INSTRUCTIONS FOR USE

21

Deadspace Volume

Pillows cushion: 19 - 36cc
Simple cushion: 27 - 65cc
Direct Seal cushion: 14 - 38cc

Storage Conditions

-4º F to 140º F (-20º C to +60º C)
15% to 95% relative humidity, non-condensing

Disposal

Dispose of in accordance with local regulations.

ComfortLite 2

22

LIMITED WARRANTY

Respironics, Inc. warrants that its mask systems (including mask frame and
cushion) (the “Product”) shall be free from defects of workmanship and
materials for a period of ninety (90) days from the date of purchase (the
“Warranty Period”).

If the Product fails under normal conditions of use during the Warranty
Period and the Product is returned to Respironics within the Warranty Period,
Respironics will replace the Product. This warranty is non-transferable and
only applies to the original owner of the Product. The foregoing replacement
remedy will be the sole remedy for breach of the foregoing warranty. This
warranty does not cover damage caused by accident, misuse, abuse, negligence,
alteration, failure to use or maintain the Product under conditions of normal
use and in accordance with the terms of the product literature, and other
defects not related to materials or workmanship. This warranty does not apply
to any Product that may have been repaired or altered by anyone other than
Respironics.

INSTRUCTIONS FOR USE

23

Respironics disclaims all liability for economic loss, loss of profits, overhead, or
indirect, consequential, special or incidental damages which may be claimed
to arise from any sale or use of the Product. Some states do not allow the
exclusion or limitation of incidental or consequential damages, so the above
limitation or exclusion may not apply to you.

THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS
WARRANTIES. IN ADDITION, ANY IMPLIED WARRANTY, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, IS SPECIFICALLY DISCLAIMED. SOME STATES DO
NOT ALLOW DISCLAIMERS OF IMPLIED WARRANTIES, SO THE ABOVE
LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU
SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS,
WHICH VARY FROM STATE TO STATE.

To exercise your rights under this limited warranty, contact your local
authorized Respironics, Inc. dealer or Respironics, Inc. at 1001 Murry Ridge
Lane, Murrysville, Pennsylvania 15668, 1-800-345-6443 (USA and Canada only)
or 1-724-387-4000.

ComfortLite 2

24

Reorder Numbers

1030493 ComfortLite 2 w/ Headgear, S,M,L Pillows Cushion
1025111 ComfortLite 2 w/ Headgear, S,M,L Simple Cushion
1025127 ComfortLite 2 w/ Headgear, 4,5,6 Direct Seal Cushion
1025225 Sub-assembly w/ Headgear, No Cushions
Combo Packs
1030494 ComfortLite 2 Combo w/ Headgear, S,M Pillows & Simple Cushions
1030495 ComfortLite 2 Combo w/ Headgear, M,L Pillows & Simple Cushions
1025112 ComfortLite 2 Combo w/ Headgear, 4,5 Direct Seal, S,M Simple Cushions
1025113 ComfortLite 2 Combo w/ Headgear, 5,6 Direct Seal, M,L Simple Cushions
Replacement Parts
1025114 ComfortLite 2 Headgear strap only
1025117 ComfortLite 2 Headgear w/ Strap
1027999 Small Accessory Pouch
1032007 ComfortLite 2 Pillows Sizing Gauge (5 pk)
1031154 ComfortLite 2 Pillows Sizing Gauge (20 pk)
1018624 ComfortLite 2 Simple Cushion Sizing Gauge (20 pk)
1018665 ComfortLite 2 Direct Seal Cushion Sizing Gauge (20 pk)
Cushions (1 pk)
Pillows Simple Direct Seal
1030502 - PETITE 1021835 - PETITE 1021802 - SIZE 1 1021816 - SIZE 5
1030503 - SMALL 1021830 - SMALL 1021806 - SIZE 2 1021817 - SIZE 6
1030504 - MEDIUM 1021823 - MEDIUM 1021807 - SIZE 3
1030505 - LARGE 1021821 - LARGE 1021815 - SIZE 4

Visit www.sleepapnea.com for a complete list of products and reorder numbers, or contact Customer Service
at 1-800-345-6443 (US and Canada) or 1-724-387-4000 to obtain a product catalog (#1027825).