Patient InterfaceInstructions for Use

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TABLE OF CONTENTS

DEVICE DESCRIPTION ..................................................... 2PATIENT INTERFACE COMPONENTS .............................. 2INDICATIONS FOR USE ..................................................... 3USING THE PATIENT INTERFACE .................................... 5PATIENT INTERFACE ASSEMBLY AND FITTING .............. 6 Mask & Valve Assembly ............................................... 6 Headgear & Mask Assembly ........................................ 8 Hose Connection .......................................................... 12CLEANING THE PATIENT INTERFACE ............................. 13TROUBLESHOOTING ........................................................ 15STORAGE .......................................................................... 16DISPOSAL ......................................................................... 16TECHNICAL SPECIFICATIONS ......................................... 16SYMBOLS ......................................................................... 17SOMNERA™ SYSTEM ORDERING INFORMATION ........... 18LIMITED 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 fits 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 flow 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 fluid 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 qualified 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 reflexes 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 difficulty or discomfort

• Difficulty 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 fits you best.b. The valve is universal, i.e., the same valve will fit 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 specific “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 fit securely but comfortably. To help you get comfortable with the feel and fit 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 final 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 flow 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 finger 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 finger 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 finger 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.

WarningDo 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.

CautionIf any visible deterioration of a system component is apparent (cracking, crazing, tears or cushion damage), the component should be discarded and replaced.

CautionThe frequency of cleaning, methods of cleaning, or the use of cleaning agents, other than those specified in this document can have an adverse effect on the materials or performance.

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TROUBLESHOOTING

Problem/Possible Cause SolutionPillows won’t seal properly, mask is uncomfortable or causes marks/ Mask or headgear may have been fitted 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-fit your mask according to the fitting instructions. Readjust the headgear so it is fitted 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. Refit 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 ScheduleContact 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 Schedule1 Mask 90 days2 Valve 90 days3 Hose 90 days4 Headgear 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 aphysician

ManufacturerNot 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-filter (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

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LIMITED WARRANTY INFORMATION

Somnera Inc. (hereafter ‘Somnera’) warrants that your Somnera product shall be free from defects in material and workmanship from the date of purchase for the period specified in the following table:

Product: Warranty period:

• Patient Interface (including valve, cushion, headgear and hose)

• Accessories

90 days

• Airbox device (including external power supply units) 2 years

This warranty is only available to the initial consumer. It is not transferable. If the product fails under conditions of normal use, Somnera will repair or replace, at its option, the defective product or any of its components. This Limited Warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by Somnera to perform such repairs; and c) any damage or contamination due to cigarette, pipe, cigar or other smoke. Warranty is void on product sold, or resold, outside the region of original purchase. Warranty claims on defective product must be made by the initial consumer at the point of purchase. This warranty replaces all other expressed or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. Somnera shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale, installation or use of any Somnera product. Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, 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 region to region. For further information on your warranty rights, contact your local Somnera dealer or Somnera office.

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Manufacturer: Somnera, Inc., 1291 Puerta Del Sol, Suite 200, San Clemente, CA 92673

See www.somnera.com for other Somnera locations worldwide. For patent information, see www.somnera.com/ip.

VELCRO® is a registered trademark of Velcro BVBA.

SOMNERA is a trademark of Somnera Inc. All rights reserved. © 2020 Somnera Inc.

03-5280 Rev AJuly 9, 2020