FusionHealth SleepSMART DreamWear User manual

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DreamWear Mask Use and Fitting for the Run-In Night
General Approach
1. Fit all subjects with the DreamWear nasal mask with under-the-nose cushion.
2. Check the mask fit using the aCPAP mask fit function as described on page 17 of this
manual. Adjust the mask accordingly.
3. If a subject cannot use the nasal mask (e.g. uncomfortable, difficulty breathing through nose
because of nasal congestion), please visually show the subject both the DreamWear full face
mask and DreamWear nasal pillows, and have him/her select the preferred style. If the
subject has no preference, try the full face mask next. The full face mask contains magnets,
so do not select if this is contraindicated. Use the aCPAP mask fit function (pg 17) to confirm
fit. Make adjustments accordingly.
4. Use the fitted mask for the 15-20-minute daytime trial prior to the run-in night. Make
adjustments to optimize comfort.
Document contents:
This document reviews details about how to use the (1) DreamWear Nasal Mask (pg 2-5), (2)
DreamWear Full Face Mask (pg 6-11), and (3) DreamWear Nasal Pillows (pg 12-16), including:
•Cautions
•The contents of the box
•Assembly/disassembly
•Mask fit
•Mask placement
•Mask adjustment
•Mask use
•Mask removal
•Mask cleaning (for study teams to have knowledge to discuss with randomized
participants)
Page 17 reviews the aCPAP mask fit function. This is followed by an illustrated summary of
mask fitting for all three mask types (pg 18-20).
Mask Fitting Assistance/FusionHealth Technical Support:
Call: 470-655-6688, 8am-7pm M-F
Email: [e-mail], anytime

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1. DreamWear nasal mask with under-the-nose cushion.
The DreamWear nasal masks will include medium-sized headgear and 4 different sizes of
cushions (Small (S), Medium (M), MediumWide (MW), Large (L)).
Assembly/disassembly (nasal mask)
Assembly
Tip: Align the triangles on the cushion and frame for proper
assembly.
1. Cushion: Press into the mask frame until the cushion clicks into
place. 9 10
Note: The end of the cushion and the opening in the mask frame
are ‘D’ shaped. The cushion end should match the frame.
2. Connector (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. Fabric sleeves: Wrap the sleeves around the mask frame and
press the strips together (see 3rd diagram just below under
“Disassembly”).
Note: The sleeve seams should be on the outside of the frame.
5. Headgear: Slide the tabs into the slots on the mask frame and
fold backwards.
Note: The Philips Respironics logo will be on the outside and
facing up when correctly assembled.
Cautions:
•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.
•Do not block or seal off the exhalation ports.
Tubing quick release

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Disassembly
6. Headgear: Undo the headgear tabs and pull through the slots in the mask frame.
7. Fabric sleeves: Undo the strips and remove from the mask frame.
8. Tubing quick release: Pull the tubing quick release from the elbow.
9. Elbow: Pull the elbow from the top of the frame.
10. Cushion: Pull the cushion from the mask frame.
Achieving the Right Fit for the
Nasal Mask
1. Hold the gauge horizontally
under the nose and select the
cushion size based on where the
outer edge of your nostrils and tip
of the nose contact the gauge.
2. The cushion opening will be
directly under the nostrils. The
cushion will hug the nose and leak
will be minimal.
3. At no time should the nose be
inside the cushion opening. If any
part of the cushion overlaps the
nose, the cushion is being worn
incorrectly. A different size
cushion may be needed.

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Putting on the DreamWear Nasal Mask
1. With the mask assembled, place the cushion under the nose.
2. Position the frame on the top of the head.
3. Pull the headgear over the back of the head.
Adjusting the Mask
4. Peel the headgear tabs away from the fabric. Adjust the length of the strap. Press the
tabs back against the fabric to reattach.
Note: Do not overtighten the headgear. Signs of overtightening include redness, sores, or
bulging skin around the edges of the mask.
5. Position the mask until it fits comfortably.
6. When finished, the elbow should rest at the top of the head.

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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 different sleeping positions. Move around until comfortable. If there are any
excessive air leaks, make final adjustments. Some air leaking is normal.
Tubing Quick Release
7. 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.
Removing the Mask
8. To keep the adjustments, remove the mask by grasping the
cushion and pulling forward away from the nose. Then pull the
cushion and mask up and off the head.

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2. DreamWear Full Face Mask
The DreamWear Full Face mask comes with 4 cushion sizes (Small, Medium, MediumWide, Large).
Assembly and Disassembly (full face mask)
Assembly
1. Cushion: Press into the mask frame until the cushion clicks into place (figure steps 11, 12).
Note: The end of the cushion and the opening in the mask frame are ‘D’ shaped. The cushion
end should match the frame.
2. Connector (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.
Cautions:
•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. 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, defibrillators and cochlear implants.
•Do not use in or near magnetic resonance imaging (MRI) equipment.
•Do not block or seal the holes and exhalation ports.
Tubing quick release

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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.
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.

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Achieving the Right Fit for a Full Face Mask
1. Hold the gauge horizontally under the nose and select the cushion size based on
where the outer edge of the nostrils and tip of the nose contact the gauge.
2. The cushion opening will be directly under the nostrils. The cushion will hug the
nose and mouth, and the leak will be minimal.
3. At no time should the nose be inside the cushion opening. If any part of the cushion overlaps
the nose, the cushion is being worn incorrectly. A different size cushion may be needed.
Putting on the Mask
1. With the mask assembled, place the cushion under the nose (figure step 2)
2. Position the frame on the top of the head (figure step 3).
3. Pull the headgear over the back of the head (figure step 4).
4. Attach the magnetic clips to the mask cushion (figure step 5).

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Adjusting the DreamWear Full Face 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 (figure step 6).
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 fits comfortably (figure step 7).
3. When finished the elbow should rest at the top of the head (figure step 8).
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 different sleeping positions. Move around until comfortable. If there are any
excessive air leaks, make final adjustments. Some air leaking is normal.

10
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 (figure step 9).
Removing the mask
To keep the adjustments, remove the mask by grasping the cushion and pulling forward away
from the nose. Then pull the cushion and mask up and off the head (figure step 10).

11

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3. DreamWear Nasal Pillows
The DreamWear nasal pillows includes medium-sized headgear and 3 different sizes of
cushions (Small (S), Medium (M), Large (L)).
The nasal pillows are interchangeable with the nasal mask/headgear. To change from the
nasal mask to the nasal pillows, pop out the nasal cushion by simply releasing the nasal
mask and snapping on the nasal pillows.
Assembly and Disassembly (nasal pillows)
Assembly
1. Align the triangles on the cushion and mask frame. Press the cushion into the frame until it
clicks into place (figure steps 9, 10).
Note: The end of the cushion and the opening in the mask frame are “D” shaped. The cushion
end should match the frame.
2. Insert the connector (elbow) into the top of the mask frame.
3. Push the tubing quick release onto the elbow until it clicks into place.
4. Wrap the fabric sleeves around the mask frame and press the strips together.
Note: The sleeve seams should be on the outside of the frame.
5. Headgear assembly:
Cautions:
•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.
•Do not block or seal off the exhalation ports.
Tubing quick release

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a. Push the end of the right headgear arm (marked with an “R”) through the right mask frame
loop. Repeat on the left side with the left (“L) headgear arm and left frame loop.
b. Slide the fabric tabs into the slots on the arms and fold backward.
Note: Once the mask is on, the letters should face outward with the “L” on the left side of your
head and the “R” on the right side.
Note: The Philips Respironics logo will be on the outside and facing up when correctly
assembled.
Disassembly
1. Gently pull each headgear arm out of the mask frame loop.
2. Undo the strips on the fabric sleeves and remove them from the mask frame.
3. Pull the tubing quick release from the elbow.
4. Pull the elbow from the top of the frame.
5. Pull the cushion from the mask frame.
�

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Cushion Sizing
1. Place the pillow’s cushion tips into the nostrils.
2. Choose the cushion so the pillow’s cushion bases sit comfortably under the nose without any
gaps (figure label G).
Note: Do not push the pillow’s cushion bases into the nostrils.
Putting on the DreamWear Nasal Pillows:
1. With the mask assembled, place the cushion under the nose and insert the pillow’s
cushion tips into the nostrils.
2. Position the frame on top of the head
3. Pull headgear over the back of the head.
4. Peel the headgear tabs away from the fabric. Adjust the length of the straps. Press the tabs
back against the fabric to reattach.
Note: Do not overtighten the headgear. Signs of overtightening include redness, sores, or
bulging skin around the edges of the mask.
3. Position the mask until it fits comfortably. When finished, the elbow should
rest at the top of the head.

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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, and breathe normally.
3. Assume different sleeping positions and move around until you are comfortable. Some air
leaking is normal, but if you notice excessive air leaks, make final adjustments.
Tubing Quick Release
The elbow is equipped with a tubing quick release. Pull-on the tubing quick release and it
disengages from the elbow and comes loose with tubing (figure step 7).

16
Removing the mask
To keep your mask adjustments intact, remove the mask by
grasping the cushion and pulling it forward, away from your
nose. Then pull the cushion
and mask up and off your head (figure step 8).
Cleaning instructions

17
Mask Fit Function
The Mask Fit function is designed to help clinicians assess and identify possible air leaks
around the subject’s mask.
To check mask fit:
1. Place the fitted mask attached to the aCPAP on the
subject.
2. In My Options, turn the dial to highlight Run
Mask Fit and then press the dial. This will activate the
Mask Fit Function. The
aCPAP will temporarily deliver 10cmH₂O.
3. Note the Green Smiley Face or Red Frowny face on
the display of the aCPAP.
4. Adjust the mask, mask cushion, and headgear
until you get a Good result (Green Smiley Face).
5. To stop Mask Fit, press the dial or Start/Stop
button.
6. If you are unable to get a good mask seal,
consider changing to a different mask and repeat the
Mask Fit function.

To adjust the mask, peel the headgear
tabs away from the fabric. Adjust the
length of the straps. Press the tabs
back against the fabric to reattach.
Note: Do not overtighten the headgear.
Position the frame on the top of the
head. Pull the headgear over the back
of the head.
Position the mask until it ts comfortably.
When nished, the elbow should rest at
the top of the head.
The cushion opening will be directly under
the nostrils. The cushion will hug the nose
and leak will be minimal.
Note: At no time should the nose be inside the cushion opening. If any part
of the cushion overlaps the nose, the cushion is being worn incorrectly.
With the mask assembled, place the
cushion under the nose.
Note: Please read the Instructions for Use for further tting information.
Nasal
Using the nasal cushion sizing gauge (included with the mask),
hold it horizontally under the nose. Select the cushion size
based on where the outer edge of the nostrils and tip of the
nose contact the gauge.
Note: Four cushion sizes (small, medium, large, medium-wide) are available.
Gel pillows
Using the gel pillows sizing gauge, place the pillows cushion tips
into the nostrils. Choose the cushion size that allows the blue gel
bases to sit comfortably under the nose without any gaps.
Note: Three cushion sizes (small, medium, large) are available.

DreamWear patient tting guide
Follow the instructions to get started tting your full face, nasal or gel pillows mask
To adjust the mask, 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.
Note: Do not overtighten the headgear.
Position the frame on the top of the head. Pull the headgear
over the back of the head.
Attach the magnetic headgear clips to the mask cushion.
Position the mask until it ts comfortably. When nished, the
elbow should rest at the top of the head.
The cushion opening will be directly under the nostrils. The
cushion will hug the nose and mouth, and leak will be minimal.
With the mask assembled, place the cushion under the nose.
Note: Please read the Instructions for use for further tting information.
Note: At no time should the nose be inside of the cushion opening. If any part of the cushion overlaps the
nose, the cushion is being worn incorrectly. A dierent size cushion may be needed.
Full face
Using the full face sizing gauge, hold horizontally under the nose and select the cushion size based on where the outer edge of your nostrils and
tip of your nose contact the gauge. Note: Four cushion sizes (small, medium, large, medium-wide) are available.

Achieving the right t with DreamWear is easy
Making it simple to nd the right t
Mask too small Large correct frame
Medium correct frame Proper t
Proper t
Proper t
Small correct frame
Mask too large
Medium frame sizing
Large frame sizing
Small frame sizing
The medium mask frame
will comfortably t most
faces. If the medium
frame does not t a
patient’s face, a small
or large mask frame
might better suit your
patient’s needs.