Philips Respironics DreamWear User manual

1
DreamWear
Full Face Mask
Instructions for use - e
1 Safety Information
Intended Use
This 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 therapy
or bi-level therapy has been prescribed.
Caution: U.S. Federal law restricts this device to sale by or on the
order of a physician.
Note: This mask is not made with natural rubber latex or DEHP.
Contraindications
This mask is not for use on patients with the following conditions:
recent eye surgery or dry eyes, hiatal hernia, excessive reux, impaired
cough reex, and impaired cardiac sphincter function. This mask is
not for use on patients who are dependent on mechanical ventilation
for their life support. This mask is not for use on patients who are
taking a prescription drug that induces vomiting, or on patients who
are uncooperative, unresponsive or unable to remove the mask by
themselves.
Warnings
•Use of this mask while the system is not on and operating may
cause rebreathing of exhaled air. Rebreathing of exhaled air for
longer than several minutes can in some circumstances lead to
suocation.

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•Discontinue use and contact your healthcare professional if any of
the following symptoms occur: skin redness, irritation, discomfort,
blurred vision, or drying of the eyes.
•Discontinue use and consult your healthcare professional if any of
the following symptoms occur: unusual chest discomfort, shortness
of breath, severe headache, eye pain or eye infections.
•Discontinue use and consult your healthcare professional if any of
the following symptoms occur: tooth, gum, or jaw soreness. Use of a
mask may aggravate an existing dental condition.
•A minimum of 3 cm H2O (hPa) must be maintained when using this
mask.
•Do not overtighten the headgear straps. Watch for signs of
overtightening, such as excessive redness, sores or bulging skin
around the edges of the mask. Loosen the headgear straps to
alleviate symptoms.
•The headgear clips and mask cushion contain magnets. Contact
your healthcare provider before you use this mask. Some medical
devices may be aected by magnetic elds. The magnetic clips in
this mask should be kept at least 2 in. (50 mm) away from any active
medical device with special attention to implanted devices such as
pacemakers, debrillators and cochlear implants.
•Do not use in or near magnetic resonance imaging (MRI) equipment.
•Do not block or seal the holes and exhalation ports.

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2 What’s in the Package
A
B
C
F
E
G
D
AHeadgear
BMagnetic headgear clip
CMask frame fabric sleeves (optional)
DMask cushion (available in S, M, L, MW)
EMask frame (available in small (SM), medium (MED), large (LG))
FElbow with built-in exhalation (do not block)
GTubing quick release (may remain in the CPAP hose)

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Back of the Cushion Front of the Cushion
HGuards
IMagnetic Clips
JFlaps
KLarge Holes (Two) in the Cushion (do not block)
LSmall Holes in the Cushion (do not block)
J
L
HH
I
K
K
J

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3 Before Use
DAILY BEFORE USE VERIFY FOR SAFETY
1. Look at the front of your mask cushion.
2. Find the two large holes.
3. Find the aps. The aps are clear, thin pieces that sit on the guards
behind the holes.
4. Do not use if the two large holes are blocked shut by the aps or
anything else (for example, mucus). a
Warning: Do not block any of the mask holes.
Note: The aps should cover the two large holes when the device
is on.
Before Use Read and Understand the Instructions Completely.
•Hand wash the entire mask before use (see Mask Care section).
•Wash your face. Do not use moisturizer or lotion on your hands or
face.
•Inspect the entire mask daily. Discard and replace any damaged or
worn parts.

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4 Achieving the Right Fit
Cushion Sizing
Four cushion sizes (S, M, L, MW)
are available. Place the cushion
sizing gauge under your nose
(as shown).
Tip: For the best
performance, use the
smallest cushion that ts
your nose.
1. Hold the gauge horizontally
under your nose and select
the cushion size based on
where the outer edge of your
nostrils and tip of your nose
contact the gauge. A mirror
or another person may assist
with sizing.
2. The cushion opening will be directly under your nostrils. The
cushion will hug your nose and mouth, and leak will be minimal.
3. At no time should your nose be inside of the cushion opening. If
any part of the cushion overlaps your nose, the cushion is being
worn incorrectly. A dierent size cushion may be needed.
Contact your healthcare provider for additional information.
Philips Respironics DreamStation Mask Type and System One
Resistance Control Settings
Using your mask with a Philips Respironics DreamStation or System
One device provides optimal comfort. The provider sets this value (X1)
on your device.

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Putting on the Mask
1. With the mask assembled (see Assembly section), place the
cushion under the nose. b
2. Position the frame on the top of your head. c
Tip: For proper sizing, see Cushion Sizing and Mask Frame
Selection sections.
3. Pull the headgear over the back of the head. d
4. Attach the magnetic headgear clips to the mask cushion. e
Adjusting the Mask
1. Peel the headgear tabs away from the fabric. Adjust the length of
the top straps. Press the tabs back against the fabric to reattach.
Repeat this step with the bottom straps. f
Note: Do not overtighten the headgear. Signs of overtightening
include redness, sores, or bulging skin around the edges of the
mask.
2. Position the mask until it ts comfortably. g
3. When nished the elbow should rest at the top of the head. h
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4
5
68
7

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Mask Frame Sizing
•Medium (MED) frame
•Small (SM) frame
•Large (LG) frame
The medium (MED) mask frame will comfortably t most faces. If the
MED frame does not t your face, contact your healthcare provider to
see if a small (SM) or large (LG) mask frame would better suit your
needs.
Tip: If the mask frame falls backward and is too close to your ears
you may need a smaller mask frame.

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Tip: If the mask frame falls forward on the head and is too close to
your eyes you may need a larger mask frame.
Using the Mask
1. Connect the CPAP tubing (included with the CPAP device) to the
tubing quick release on the elbow.
2. Turn the therapy device on. Lie down. Breathe normally.
3. Assume dierent sleeping positions. Move around until comfortable.
If there are any excessive air leaks, make nal adjustments. Some air
leaking is normal.
Tubing Quick Release
The elbow is equipped with a tubing
quick release. Pull on the tubing quick
release and it will disengage from
the elbow and come loose with the
tubing. i
Removing the Mask
To keep your adjustments, remove the
mask by grasping the cushion and pulling
forward away from the nose. Then pull
the cushion and mask up and o of the
head. j
5 Mask Care
Cleaning Instructions
Daily: Hand wash the non-fabric parts.
Weekly: Hand wash the fabric parts.
1. Disassemble the mask (see Disassembly section).
2. Submerge and hand wash the mask in warm water with liquid
dishwashing detergent.
Note: Ensure there are no air pockets present inside the mask parts
while submerged.
3. Rinse thoroughly.
4. Lay the headgear and fabric sleeves at or line dry. Make sure the
entire mask is dry before use.
Note: Do not place the fabric parts into a clothes dryer.
Caution: Any deviation from these instructions may impact the
performance of the product.
910

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Caution: Do not use bleach, alcohol, cleaning solutions containing
bleach or alcohol, or cleaning solutions containing conditioners or
moisturizers.
Dishwashing Instructions
In addition to hand washing, the mask may be cleaned in the
dishwasher once a week.
Caution: Use a mild liquid dish washing detergent only to wash the
mask.
1. Remove the fabric parts. Do not wash the fabric parts in the
dishwasher.
2. Wash in the top shelf of the dishwasher.
Note: Do not use the drying cycle on the dishwasher.
3. Air dry. Make sure the mask is dry before use.
Caution: Do not use bleach, alcohol, cleaning solutions containing
bleach or alcohol, or cleaning solutions containing conditioners or
moisturizers.
6 Assembly and Disassembly
Assembly
1. Cushion: Press into the mask frame
until the cushion clicks into place.
kl
Note: The end of the cushion and
the opening in the mask frame are
‘D’ shaped. The cushion end should
match the frame.
2. Elbow: Insert into the top of the mask
frame.
3. Tubing quick release: Push the tubing
quick release onto the elbow until it
clicks into place.
4. (Optional) Fabric sleeves: Wrap the
sleeves around the mask frame and
press the strips together.
Note: The sleeve seams should be on
the outside of the frame.
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5. Headgear: Slide the headgear top strap tabs into the slots on the
mask frame and fold backwards. Attach the magnetic headgear
clips.
Note: The Philips Respironics logo will be on the outside and facing
up when correctly assembled.
Disassembly
1. Headgear: Undo the headgear tabs and pull through the slots in the
mask frame. Turn the magnetic headgear clips away from the mask
frame.
2. Fabric sleeves: Undo the strips and remove from the mask frame.
3. Tubing quick release: Pull the tubing quick release from the elbow.
4. Elbow: Pull the elbow from the top of the frame.
5. Cushion: Pull the cushion away from the mask frame.
7 Healthcare Provider & Clinician Information
Useful Life
The useful life of the DreamWear Full Face mask depends on the
use conditions and maintenance (cleaning, institutional disinfection,
and component replacement) of the device. Inspect the mask parts
regularly for damage or wear. Replace components as deemed
necessary.
Multi-Patient Use
Refer to the Disinfection Guide for Professional Users to reprocess
between patients in a clinical setting. Access the latest version of the
Disinfection Guide at www.healthcare.philips.com or by contacting
customer service at 1-800-345-6443 (USA or Canada only) or
[phone].

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Specications
The technical specications of the mask are provided for your
healthcare professional to determine if it is compatible with your
CPAP or bi-level therapy device.
Warning: Use outside of these specications may result in
ineective therapy The pressure ow curve shown below is an
approximation of expected performance. Exact measurements
may vary.
Pressure Flow Curve
Flow Rate (SLPM)
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
0 5 10 15 20 25 30
Pressure (cm H
2
O)
Resistance with Flaps Closed to Atmosphere
Drop in Pressure (cm H
2
O) at 50 SLPM at 100 SLPM
All Cushion Sizes 0.9 3.1
Closed to Atmosphere: A minimum of 3 cm H
2
O must be maintained
to ensure that the aps close.
Open to Atmosphere: At an airway pressure less than -1 cm H
2
O, the
aps will be open.
Inspiratory and Expiratory Resistance with Flaps Open to
Atmosphere at 50 SLPM (cm H2O)
Inspiratory Resistance 0.4
Expiratory Resistance 1.8

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Deadspace (mL)
Frame size: SM MED LG
Cushion size:
S: 176.3 S: 179.3 S: 182.2
M: 182.7 M: 185.7 M: 188.6
L: 201.3 L: 204.3 L: 207.2
MW: 185.2 MW: 188.2 MW: 191.1
Sound Levels (dBA)
A-weighted Sound Power Level 24.0
A-weighted Sound Pressure Level at 1 m 16.5
Disposal
Dispose of in accordance with local regulations.
Storage Conditions
Temperature: -4° F to 140° F (-20° C to 60° C)
Relative Humidity: 15% to 95%, non-condensing

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8 Symbols Glossary
Symbol Title and Meaning Reference
X1 Philips Respironics DreamStation Mask
Type and System One Resistance
Control Value
Indicates the therapy device comfort
setting.
-
Prescription device
Caution: U.S. federal law restricts
this device by or on the order of a
physician.
-
Not Made with Natural Rubber Latex
Indicates that this mask is not made
with natural rubber latex.
-
Manufacturer
Indicates the medical device
manufacturer.
IEC 60878
ISO 7000-3082
Symbol 5.1.1,
ISO 15223-1
Humidity limitation
Indicates the range of humidity to
which the medical device can be safely
exposed.
IEC 60878
ISO 7000-2620
Symbol 5.3.8,
ISO 15223-1
Temperature limit
Indicates the storage temperature limits
to which the medical device can be
safely exposed.
IEC 60878
ISO 7000-0632
Symbol 5.3.7,
ISO 15223-1
Caution, consult accompanying
documents.
IEC 60878
Symbol 5.1.2,
ISO 15223-1
Batch code
Indicates the manufacturer’s batch
code so that the batch or lot can be
identied.
IEC 60878
ISO 7000-2492
Symbol 5.1.5,
ISO 15223-1

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Symbol Title and Meaning Reference
Reorder number
Indicates the manufacturer’s catalogue
number so the medical device can be
identied.
ISO 7000-2493
Symbol 5.1.6,
ISO 15223-1
Operator’s manual; operating
instructions
Consult instructions for use.
ISO 7000-1641
Symbol 5.4.3,
ISO 15223-1
Wash by hand
Indicates that cleaning the textile article
is allowed only by washing by hand.
ISO 7000-3125
Do not bleach
Indicates that bleaching textile article is
not allowed.
ISO 7000-3124
Do not tumble dry
Indicates that tumble drying is not
allowed in the drying process.
ISO 7000-3109
Do not iron
Indicates that ironing is not allowed.
ISO 7000-3113
Do not dry clean
Indicates that dry cleaning is not
allowed.
ISO 7000-3114
ISO 7000:2014, Graphical symbols for use on equipment - Registered
symbols
ISO 15223-1:2012, Medical devices - Symbols to be used with medical
devices labels - General requirements
IEC/TR 60878: 2015, Graphical symbols for electrical equipment in
medical practice

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9 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 nontransferable 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 jurisdictions
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
JURISDICTIONS 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 UNDER LAWS APPLICABLE IN YOUR
SPECIFIC JURISDICTION.
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, USA, or Respironics
Deutschland GmbH & Co KG, Gewerbestraße 17, 82211 Herrsching,
Germany.

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Limited Warranty for Australia and New Zealand only
Note: For Australian and New Zealand customers this warranty
replaces the warranty contained above.
1. Respironics, Inc., a Philips company (“Philips Respironics”),
warrants that the Products shall be free from defects of workmanship
and materials and will perform in accordance with the Product
specications. 2. This warranty is valid for a period of two (2) years
from the date of purchase from an authorized Philips Respironics
dealer. 3 If the Product is found to contain a defect of workmanship
or materials or fails to perform in accordance with the Product
specications during the applicable warranty period, Philips Respironics
will repair or replace, at its option, the defective material or part. 4. The
customer is responsible for returning the product to an authorised
Philips Respironics dealer, and collecting the product from the
authorised Philips Respironics dealer after repair or replacement, at its
own cost. Philips Respironics is responsible only for the freight cost of
transporting the product between the authorised Philips Respironics
dealer and Philips Respironics. Philips Respironics reserves the right
to charge an evaluation and postage fee for any returned Product as
to which no problem is found following investigation. 5. This warranty
does not cover damage caused by accident, misuse, abuse, alteration,
and other defects not related to materials or workmanship. 6. The
warranty provided by Philips Respironics herein is not transferrable by
the Buyer in the event of any sale or transfer of Products purchased
by the Buyer from an authorized Philips Respironics dealer. 7. To the
extent permitted by law, where the Buyer has the benet of an implied
guarantee under the Australian Consumer Law, but the Product is not
of a kind ordinarily acquired for personal, domestic or household use or
consumption Philips Respironics’ liability shall be limited, at the option
of Philips Respironics, to the replacement or repair of the Product or the
supply of an equivalent Product. 8. To exercise your rights under this
warranty, contact your local authorised Philips Respironics dealer. A list
of all authorised dealers is available at the following link:
http://www.philips.com.au/healthcare.

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Alternatively, you can make a claim under this warranty by contacting
Philips Respironics directly at: Philips Electronics Australia Limited,
65 Epping Road, North Ryde NSW 2113, Australia. Tel: [phone],
Email: pr[email protected]. 9. The following statement is provided
to a Buyer who is a “consumer” under the Australian Consumer Law:
Our goods come with guarantees that cannot be excluded under the
Australian Consumer Law. You are entitled to a replacement or refund
for a major failure and for compensation for any other reasonably
foreseeable loss or damage. You are also entitled to have the good
repaired or replaced if the goods fail to be of acceptable quality
and the failure does not amount to a major failure. 10. The following
statement is provided to a Buyer who is a “consumer” under the
Consumer Guarantees Act 1993, New Zealand: Our goods come with
guarantees that cannot be excluded under the Consumer Guarantees
Act 1993. This guarantee applies in addition to the conditions and
guarantees implied by that legislation.
AUSTRALIAN SPONSOR DETAILS:
Philips Electronics Australia Ltd.
65 Epping Road, North Ryde, NSW 2113
Australia.