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 qualied 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 reexes 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 difculty or discomfort
• Difculty 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 specic “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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