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Somnera System Instructions For Use Manual

Patient interface
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Patient Interface
Instructions for Use

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Summary of Contents for Somnera Somnera System

  • Page 1 Patient Interface Instructions for Use...

  • Page 3: Table Of Contents

    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...

  • Page 4: Device Description

    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 ™...

  • Page 5: Indications For Use

    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.
  • Page 6 • 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. •...

  • Page 7: Using The Patient Interface

    • 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. ™ ™...

  • Page 8: Patient Interface Assembly And Fitting

    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.
  • Page 9 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.

  • Page 10: Headgear & Mask Assembly

    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)
  • Page 11 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 ®...
  • Page 12 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...
  • Page 13 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.

  • Page 14: Hose Connection

    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).

  • Page 15: Cleaning The Patient Interface

    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.
  • Page 16 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.

  • Page 17: Troubleshooting

    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:...

  • Page 18: Storage

    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.

  • Page 19: Symbols

    SYMBOLS The following symbols may appear on your product or packaging: CAUTION: Federal law restricts Reference Lot Number this device to sale by Number or on the order of a physician CAUTION: Read Not made with natural all warnings and Manufacturer rubber latex precautions in...

  • Page 20: Somnera ™ System Ordering Information

    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.

  • Page 21: Limited Warranty Information

    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;...
  • Page 22 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 A July 9, 2020...

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