Somnera Somnera System User manual

Patient Interface
Instructions for Use

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TABLE OF CONTENTS
DEVICE DESCRIPTION ..................................................... 2
PATIENT INTERFACE COMPONENTS .............................. 2
INDICATIONS FOR USE..................................................... 3
USING THE PATIENT INTERFACE .................................... 5
PATIENT INTERFACE ASSEMBLY AND FITTING .............. 6
Mask & Valve Assembly ............................................... 6
Headgear & Mask Assembly ........................................ 8
Hose Connection .......................................................... 12
CLEANING THE PATIENT INTERFACE ............................. 13
TROUBLESHOOTING ........................................................ 15
STORAGE .......................................................................... 16
DISPOSAL ......................................................................... 16
TECHNICAL SPECIFICATIONS ......................................... 16
SYMBOLS ......................................................................... 17
SOMNERA™SYSTEM ORDERING INFORMATION ........... 18
LIMITED WARRANTY INFORMATION .............................. 19

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DEVICE DESCRIPTION
The Somnera™Patient Interface connects to the Somnera™Airbox to treat obstructive sleep
apnea in the home environment by providing positive airway pressure during each sleep night.
The components of the Somnera™Patient Interface include: a Mask Cushion (Nasal Pillow or
Nasal Mask), Valve, Headgear, and Hose. The nasal pillow or nasal mask ts under or over
the nose, respectively. The valve inserts into the mask and allows connection to the hose. All
components have custom connections to ensure that they can only be connected to compatible
Somnera devices.
PATIENT INTERFACE COMPONENTS
1. Mask Cushion [Either a Nasal Pillow
(P1) or a Nasal Mask (M1)]
2. Valve (V1)
3. Hose (H1)
4. Headgear Straps (S1) [Comprised of
two silicone straps and one VELCRO®
backstrap]
1.
2.
3.
4.

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This manual describes the operating methods, technical parameters and maintenance instructions
of the device. For future reference, keep this manual in a convenient, easily accessible place.
Warning: Read this entire manual before using this device.
Caution: In the US, federal law restricts this device to sale by or on the order of a physician.
Caution: The components of the Somnera™System are not compatible with any other, non-
Somnera positive airway pressure devices.
INDICATIONS FOR USE
The Somnera™System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic
breathing pressure to a patient. It provides positive airway pressure during expiration and also
during an incipient apnea. The system includes a dedicated ow generator and a patient interface,
and is intended for use in the home environment. This system is to be used by adult patients
weighing more than 66 lbs (30 kg).
Contraindications
• Severe bullous lung disease
• A pneumothorax
• Pathologically low blood pressure
• Dehydration
• Cerebrospinal uid leak, recent cranial surgery or trauma
Warnings
• This device should only be used with the Somnera™Airbox. The Somnera™System Mask,
Hose, Valve and Accessories are not compatible with any other respiratory systems or
accessories and use with other systems could reduce the effectiveness of the treatment,
result in improper operation or cause potential safety hazards.
• Do not use this device in an MR environment.
• Make sure you arrange the Hose so that it will not twist around your head or neck.

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• If you notice unexplained changes in the performance of this device or if it is making unusual
or harsh sounds, discontinue use, then contact your care provider or supplier. Failure to do
so could result in improper operation or potential safety hazards.
• The Mask must be used under qualied supervision for patients who are unable to remove
the Mask by themselves. The Mask may not be suitable for those predisposed to aspiration.
• This Mask is not for use on patients with impaired laryngeal reexes or other conditions
predisposing to aspiration in the event of regurgitation or vomiting.
• This Mask is not compatible with supplemental oxygen.
• Discontinue using this Mask if you have ANY adverse reaction to the use of the mask and
consult your healthcare provider.
Precautions
• Carefully inspect the package prior to use for damage to the contents. If the contents are
damaged, DO NOT USE and contact your supplier.
• Replace any damaged equipment immediately. If damage is found call your supplier.
• Follow the cleaning instructions in this user guide.
• Do not attempt to operate the system before thoroughly reading the Instructions for Use. For
future reference, keep these documents in a convenient, easily accessible place.
• An acute upper respiratory tract infection, sinusitis or an ear infection may require temporary
discontinuation of treatment. Consult your healthcare provider.
• Keep the area around the device dry, clean and clear of anything (e.g., clothes, pillows,
bedding) that could cover the device.
• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or
antibacterial soaps or scented oils to clean the device. These solutions may cause damage
and reduce the life of the device.
• Consult your healthcare provider to determine whether you should use a chinstrap accessory
(sold separately) to prevent mouth breathing.

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Adverse Effects
You should report unusual chest pain, severe headache or increased breathlessness to you
prescribing physician. The following side effects may arise during the course of therapy with
the device:
• Drying of the nose, mouth or throat
• Nosebleed
• Nasal congestion
• Ear or sinus discomfort
• Skin, nose or eye irritation
• Skin rash
• Headache
• Breathing difculty or discomfort
• Difculty sleeping
• Bloating
USING THE PATIENT INTERFACE
The Somnera™System Patient Interface should only be used with the Somnera™Airbox.

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PATIENT INTERFACE ASSEMBLY AND FITTING
1. Mask & Valve Assembly
a. The mask is available in a selection of sizes. Choose the size the ts you best.
b. The valve is universal, i.e., the same valve will t all sizes of either the nasal pillow or the
nasal mask.
c. When assembled correctly, the mask sits within a circumferential groove in the valve (Fig. 1).
NOTE: The valve does not require any specic “clock face” orientation within the mask.
Fig. 1: Unassembled Mask and Valve

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d. To insert valve into mask, gently squeeze the valve aperture of the mask (Fig. 2a) and
position part of it to sit within the groove on the valve (Fig. 2b).
Fig. 2a: Gently squeeze mask Fig. 2b: Position mask within valve groove
e. While holding the valve in place, move clockwise or counterclockwise around the entire
circumference, stretching the mask over the valve until it seats in the valve groove (Fig. 3a).
Continue until the mask is fully seated within the valve groove (Fig. 3b).
Fig. 3a: Stretch mask to seat in groove Fig. 3b: Assembled Mask & Valve

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2. Headgear & Mask Assembly
a. Orient the two headgear silicone straps as shown in Fig. 4.
Fig. 4: Silicone Headstraps (disconnected)
b. Connect the silicone straps together as shown in Fig. 5.
Fig. 5: Silicone Headstraps (connected)

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c. Place each headgear strap notch over each mask button to connect the headgear to the
mask (Figures 6a and 6b).
Fig. 6a: Orient notch with button Fig. 6b: Assembled straps
d. Insert the backstrap tabs into each slot in the silicone straps. Ensure that the VELCRO®side
is facing away from the mask (Fig. 7a and 7b).
Fig. 7a: Insert backstrap tab Fig. 7b: Mask & Headgear assembled

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e. When worn, the mask should be oriented such that the size letter (S, M, or L) is on the top of
the mask (Fig. 8).
Fig. 8: Size letter on top side of mask

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f. To place the mask on, position the assembled mask at the nose while pulling the headgear
over the head (Fig. 9a). The silicone straps should be positioned on the crown of the head
and the backstrap should be positioned around the back of the head (Fig. 9b). Tighten the
silicone straps and/or the backstrap, as needed, to t securely but comfortably. To help you
get comfortable with the feel and t of the mask, it is recommended that you wear the mask
(without the hose) several times while awake before using it when you go to sleep.
Fig. 9a: Pull mask over head Fig. 9b: Correct nal positioning
Caution: Do not overtighten the headgear.

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3. Hose Connection
a. To connect the hose to the valve, gently squeeze the wings on either side of the hose
connection, insert into center valve ring then release the wings (Fig. 10a and 10b). To
disconnect the hose from the valve, gently squeeze the wings while pulling the hose
connector away from the valve ring.
Fig. 10a: Squeeze wings on hose. Fig. 10b: Release tension on wings.
b. The hose magnetically connects to the
Somnera™Airbox via a magnet within the
ow generator hose connector. Insert the
hose into the hose connector (Fig. 11a).
To disconnect, pull the hose back.
Fig. 11a: Insert hose connector.

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CLEANING THE PATIENT INTERFACE
Note: Patient Interface Components should only be hand washed in warm water using mild,
unscented dishwashing soap. All components should be rinsed well with drinking quality water
and allowed to air dry out of direct sunlight.
Daily/After each use:
1. Disassemble into the 5 individual components before cleaning: Mask (nasal pillow or nasal
mask), valve, hose, and 2 headgear straps.
2. Fill a clean basin or container with warm water and add enough mild, unscented dishwashing
soap (e.g., Dawn) until soap bubbles form.
3. Mask Cleaning
3.1. Submerge the mask in the soapy water and agitate for at least 5 seconds.
3.2. While submerged, use a nger or soft brush to gently rub the inside and outside
of the mask.
3.3. Clean until you do not see any visible debris on the mask.
4. Valve Cleaning
4.1. Submerge the valve in the soapy water and agitate for at least 5 seconds.
4.2. While submerged, use a nger or soft brush to gently rub both sides of the valve.
4.3. Clean until you do not see any visible debris on the valve.
5. Hose Cleaning
5.1. Submerge the hose in the soapy water and agitate for at least 5 seconds.
5.2. Then use your thumbs to plug both ends of the hose, remove from the sink or basin,
and move the hose ends up and down to help clean the inside of the hose.
5.3. Return the hose to the sink or basin and clean until you do not see any visible debris
on the hose.

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6. Headgear Cleaning
6.1. Submerge the headgear straps in the soapy water and agitate for at least 5 seconds.
6.2. While submerged, use a nger or soft brush to gently rub both sides of each strap
6.3. Clean until you do not see any visible debris on the straps.
7. Remove all of the components from the basin or container.
8. Rinse each of the components under warm running water for at least 5 seconds. Continue
rinsing until no visible soap remains, then set aside each component on a towel to dry.
8.1. Make sure to rinse both the inside and outside of the mask and hose with warm
running water.
9. Hang the hose over a hook so that both ends are facing downwards to allow the hose to
drain and facilitate drying.
10. Allow all of the components to air dry out of direct sunlight before reassembling for the
next use.
Warning
Do not use aromatic-based solutions or scented oils, (e.g. eucalyptus or essential oils) bleach,
alcohol or products that smell strongly (e.g. citrus) to clean any of the mask components. Residual
vapors from these solutions can be inhaled if not rinsed thoroughly. They may also damage the
mask, causing cracks.
Caution
If any visible deterioration of a system component is apparent (cracking, crazing, tears or cushion
damage), the component should be discarded and replaced.
Caution
The frequency of cleaning, methods of cleaning, or the use of cleaning agents, other than those
specied in this document can have an adverse effect on the materials or performance.

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TROUBLESHOOTING
Problem/Possible Cause Solution
Pillows won’t seal properly, mask is uncomfortable
or causes marks/ Mask or headgear may have
been tted or adjusted incorrectly
Check that the orientation of the mask is
correct. The “S, M, or L” should be oriented so
it is on the top of the mask. Re-t your mask
according to the tting instructions. Readjust
the headgear so it is tted comfortably.
Patient interface is making noises/Air is leaking
at one or several of the components of the system
Check that the mask sits within the groove
of the valve properly. Check that the hose is
connected to the valve properly. Check that
the valve is not damaged. Check that the hose
is connected to the Airbox properly. Ret or
reposition your mask. Adjust your headgear.
One or both of the nasal pillows are squashed or
misshapen or the inner wall of the nasal mask or
one or both of the nasal pillows is incorrect
Squeeze individual nasal mask or nasal pillow
sides to return it to original shape. If it does not
return to shape or it is damaged replace the
part. Contact your local Somnera dealer.
Headgear is too loose Adjust the headgear straps & VELCRO®backstrap.
Component appears damaged or worn Replace the part. Contact your local Somnera
dealer.
Replacement Schedule
Contact your supplier to replace the components of the Somnera System Patient Interface
according to the following replacement schedule, or if any components become cracked, torn,
discolored or damaged in any way:
Item Description Replacement Schedule
1 Mask 90 days
2Valve 90 days
3Hose 90 days
4Headgear 90 days

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STORAGE
Ensure that the Patient Interface is thoroughly clean and dry before storing it for any length of time.
Store it in a dry place out of direct sunlight.
DISPOSAL
This Patient Interface does not contain any hazardous substances and may be disposed of with
your normal household refuse.
TECHNICAL SPECIFICATIONS
• Dead space information
• Physical dead space is the empty volume of the mask.
• For the Nasal Pillow, the dead space is 29 ml, 31 ml and 33 ml for the small, medium
and large sizes, respectively.
• For the Nasal Mask, the dead space is 79 ml, 86 ml and 91 ml for the small, medium
and large sizes, respectively.
• Therapy pressure
• 4 to 20 [cm H2O]
• Environmental conditions
• Store in a dry place out of direct sunlight
• Sound
• When operating pressure is 10 cm H2O, the device sound pressure level should be less
than or equal to 23 dBA with uncertainty of 2.5 dBA

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SYMBOLS
The following symbols may appear on your product or packaging:
Reference
Number Lot Number
CAUTION:
Federal law restricts
this device to sale by
or on the order of a
physician
Manufacturer Not made with natural
rubber latex
CAUTION: Read
all warnings and
precautions in
instructions for use
Keep away
from sunlight
MR unsafe. Do not use
in the vicinity of a MRI
device.
Humidity limitation
Temperature
limitation
Refer to instruction
manual
Do not use if package
is damaged

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SOMNERA™SYSTEM ORDERING INFORMATION
Manufacturer Product Name Catalog Number
SOMNERA, INC. Somnera™System (Pillow) 67890
SOMNERA, INC. Somnera™System (Nasal Mask) 98765
SOMNERA, INC. Somnera™Airbox – A1 10101
SOMNERA, INC. Air-lter (Pack) 10005
SOMNERA, INC. Airbox A/C Plug & Cord 10010
SOMNERA, INC. H1 - Hose 33333
SOMNERA, INC. V1 - Valve 11111
SOMNERA, INC. P1 - Pillow (Small) 44444
SOMNERA, INC. P1 - Pillow (Medium) 55555
SOMNERA, INC. P1 - Pillow (Large) 66666
SOMNERA, INC. M1- Nasal Mask (Small) 77777
SOMNERA, INC. M1- Nasal Mask (Medium) 88888
SOMNERA, INC. M1- Nasal Mask (Large) 99999
SOMNERA, INC. P3 - Pillow Kit 45600
SOMNERA, INC. M3 - Nasal Mask Kit 78900
SOMNERA, INC. S1 - Headgear Straps 22222
SOMNERA, INC. B1 - VELCRO®Backstrap Replacement 20202
SOMNERA, INC. Airbox Travel Bag Replacement 10000