Philips OptiLife User manual

1067740
JDH 03/30/2010
Murrysville, PA 15668 USA
OptiLife
© 2010 Koninklijke Philips Electronics N.V. All rights reserved. Instructions for Use

INSTRUCTIONS FOR USE
1
OptiLife
Nasal Mask
3 Intended Use
4 Warnings
6 Symbols
7 Before Use
7 Cleaning Instructions
9 System One Resistance Control
10 Attaching the Cushion
11 Sizing the Pillows Cushion
11 Sizing the Cradle Cushion
13 Fitting the Mask and Headgear
15 Removing the Headgear and Interface
16 Tube Management
16 Disposal
17 Specifications
19 Limited Warranty
Table of Contents

OptiLife Nasal Mask
2
OptiLife
Nasal Mask
OptiLife
I
A
B
C
D
EF
G
H
Figure 1
A = Top Strap
B = Side Strap
C = Cushion
D = Headgear Slots
E = Exhalation Port (Do
not block)
F = Mask
G = Support Band
H = 6”Tube
I = Tube Management Clip

INSTRUCTIONS FOR USE
3
Intended Use
The OptiLife Nasal Mask is intended to provide an interface for ap-
plication of CPAP or bi-level therapy to patients.The mask is for single
patient use in the home and multi-patient use in the hospital/institu-
tional 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 OptiLife Nasal
Mask so a separate exhalation port is not required.
CAUTION
US federal law restricts this device to sale by or on the order of a physician.

OptiLife Nasal Mask
4
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.
If oxygen is used with the device, the•
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.

INSTRUCTIONS FOR USE
5
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.
Hand wash prior to first use. Inspect the mask for damage or•
wear (cracking, crazing, tears, etc). Discard and replace any
components as necessary.
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.

OptiLife Nasal Mask
6
Symbols
Symbol Description
General Caution or Warning
Consult instructions for use
Note
Tip
System One Resistance Control Setting
Does not contain natural rubber latex

INSTRUCTIONS FOR USE
7
Before Use
Hand wash mask.•
Read and understand the instructions completely.•
Remove the Quick Fit Tips from the headgear.•
Clean your face before wearing the mask.•
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 mild1.
liquid dish 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 out2.
of direct 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 have3.
visibly deteriorated (cracking, crazing, tears, etc). Replace the
mask if the cushion becomes hardened.

OptiLife Nasal Mask
8
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 Respironics Customer
Service at 1-724-387-4000 or Respironics Germany at
[phone].
Dishwashing Instructions
In addition to hand washing, the mask may be cleaned in the dish-
washer once a week.
Caution: Use a mild liquid dish washing detergent only.
Remove the headgear. Do not wash the headgear in the1.
dishwasher.
Separate the cushion and the faceplate and wash in the top shelf2.
of the dishwasher.
Air dry. Make sure the mask is dry before use.3.
Inspect all parts for damage or wear; replace any parts that have4.
visibly deteriorated (cracking, crazing, tears, etc). Replace the
mask if the cushion becomes hardened.

INSTRUCTIONS FOR USE
9
System One Resistance Control
This mask uses the System One Resistance Control setting
(e.g., ). The following symbol may appear on your therapy
device (e.g., ). This represents the level of mask resistance
compensation. Match the setting to the mask if appropriate.
Pillows Cradle Cushion
P X3 S X1
S X4 M X1
M X2 LN X1
L X1 L X1
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.

OptiLife Nasal Mask
10
Attaching the Cushion
Your mask may come with a Cradle Cushion
in addition to the Pillows Cushion. Both
cushions attach to the mask in the same way.
Look at the markings on the cushion1.
to determine the correct placement of
the cushion onto the attachment hub
(Figure 2). The OptiLife name should be
on the front (away from your face) and the
arrows on the cushion and mask should be
on the inside (closer to your face).
To attach a cushion, place one of the2.
cushion attachment holes over the
appropriate post, pull the cushion over the
cushion attachment hub, and attach the
other side in the same manner (Figure 3).
The cushion will stretch without tearing.
To remove a cushion, simply peel it off3.
of the cushion attachment hub. For best
results, grab the bottom of one side of the
cushion near the attachment post and pull
the cushion over the hub.
Figure 2
Figure 3
A = Hole
B = Cushion Attachment
Hub
C = Post
M
OptiLife
A
B
C

INSTRUCTIONS FOR USE
11
Figure 5
Sizing the Pillows Cushion
The OptiLife Pillows Cushions are available
in multiple sizes to provide the most
comfortable fit and to deliver the best
therapy. To determine which size to use,
select a cushion that fills your nostrils
comfortably without any gaps between the
cushion and the walls of your nostrils.
Rotate the pillows cushion so it is at an1.
angle (approximately 45°) with the cushion
attachment hub before inserting it into
your nose (Figure 4).
Place the pillows cushion into your nostrils.2.
Your chin should rest comfortably in the
support band (Figure 5).
Sizing the Cradle Cushion
The OptiLife Cradle Cushions are available
in multiple sizes to provide the most
comfortable fit and to deliver the best
therapy. In most cases, the sizing of the
Cradle Cushion matches the sizing of the
Figure 4
Fr ont
Slot
Back
Slot

OptiLife Nasal Mask
12
Pillows Cushion. To determine which size Cradle Cushion to use,
first determine the correct pillows size to use. Then, use the table
below as a starting point for the Cradle Cushion.
Pillows Cushion Size Cradle Cushion Size
P S
S S or M
M M
L L or LN
Before putting on the mask, make su1. re the Cradle Cushion is in
an upright position (Figure 6).
Place the cushion so that it rests underneath your nose. No part2.
of your nose should be inserted into the cushion. Your chin should
rest comfortably in the support band.
Figure 6
Front
Slot
Back
Slot
Figure 7

INSTRUCTIONS FOR USE
13
Comfort Tip
Position headgear in either slot to optimize fit
and comfort. For the Pillows Cushion, start
in the back slot and move to the front slot
if necessary. For the Cradle Cushion, start
in the front slot and move to the back slot if
necessary.
Fitting the Mask and
Headgear
Pull the elastic headgear on over your1.
head. The adjustable top strap should be
placed comfortably over the top of your
head so that the headgear side straps rest
just above the ears. The back strap will sit
at the base of your head.
Adjust the side straps so that the cushion2.
fits snugly and comfortably in your nostrils
(Pillows Cushion) or under your nose
(Cradle Cushion). Do not overtighten the
headgear side straps.

OptiLife Nasal Mask
14
Adjust the support band so that it3.
rests snugly against your chin. Do not
overtighten the support band (Figure 8).
Adjust the angle of the cushion to achieve4.
the best fit and comfort by rotating the
cushion backward or forward on the
cushion attachment hub.
Connect the interface to the tubing of5.
your CPAP or bi-level device. Lie down
and turn on the airflow.
Make final adjustments while lying down.6.
Headgear Fitting Tips
If the side headgear straps are sitting on1.
or covering the ears, tighten the top strap
to move the side straps up and off of the
ears. Re-adjust the side straps and chin
support band for comfort.
If the back headgear strap is sliding up on2.
the head, loosen the top strap and move
the back strap down toward the neck.
Re-adjust the side straps and chin support
band for comfort.
If you have long and silky hair, place your3.
hair over the back headgear strap to help
secure the headgear.
Figure 8

INSTRUCTIONS FOR USE
15
Cushion Seal Fitting Tips
If you experience leaks,
Try a different size cushion.1.
Verify that the support band is not2.
overtightened on your chin.
Move the headgear to a different slot on3.
the interface.
Rotate the cushion forward or backward4.
on the attachment hub.
Re-adjust the mask fitting while lying5.
down.
Review Tube Management suggestions for6.
additional tips.
Removing the Headgear and
Interface
You can quickly and easily remove the
interface by grabbing the back headgear strap
and sliding it forward over your head.

OptiLife Nasal Mask
16
Tube Management
Use the tube management clip to position the
CPAP or bi-level tubing to accommodate your
needs (Figure 9). The fabric ring can be placed
anywhere along the tube and the clip can be
attached to your clothing or pillow case for
easier tube management.
Disposal
Dispose of in accordance with local
regulations.
Figure 9

INSTRUCTIONS FOR USE
17
10
20
30
40
50
60
Whisper Swivel 2
Pillows/Cradle Cushion
403632282420161284
Pressure cm H2O (hPa)
Exhaust Leak Rate (SLPM)
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

OptiLife Nasal Mask
18
Pressure Drop cm H2O (hPa)
50 slpm 100 slpm
All Sizes < 2.9 < 9.5
Deadspace
Pillows Cushion ≤ 16.1 mL
Cradle Cushion ≤ 42.0 mL
Storage Conditions
Temperature -4° F to 140° F (-20° C to 60° C)
15% to 95% relative humidity, non-condensing

INSTRUCTIONS FOR USE
19
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.
Respironics disclaims all liability for economic loss, loss of prots, 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 ADDI-
TION,ANY IMPLIED WARRANTY, INCLUDING ANY WARRANTY OF MERCHANTABIL-
ITY 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.