Full face mask
`
`User guide
`English
`
`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 1
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`

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`Fitting / Mise en place / Colocación / Colocação
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`1
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`3
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`6
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`2
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`4
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`5
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`7
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`i
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 2
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`

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`Adjustment / Ajustement / Ajuste / Ajuste
`
`Removal / Retrait / Remoción / Remoção
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`1
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`2
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`ii
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 3
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`

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`Disassembly / Démontage / Desensamblado /
`Desmontagem
`
`2
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`1
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`3
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`iii
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 4
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`

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`Reassembly / Remontage / Reensamblado / Remontagem
`
`1
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`2
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`iv
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 5
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`

`

`Cleaning the vent / Nettoyage de l’orifice de ventilation
`/ Limpieza del orificio de ventilación / Limpeza do
`respiradouro
`
`v
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 6
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`

`

`ENGLISH
`
`Full face mask
`
`
`
`
`
`
`
`Thank you for choosing the AirFit F20. This document provides the user
`instructions for the AirFit F20 and AirFit F20 for Her masks referred to
`collectively as AirFit F20 throughout this manual.
`Using this guide
`Please read the entire guide before use. When following instructions,
`refer to the images at the front of the guide.
`Intended use
`The AirFit F20 is a non-invasive accessory used for channeling airflow
`(with or without supplemental oxygen) to a patient from a positive airway
`pressure (PAP) device such as a continuous positive airway pressure
`(CPAP) or bilevel system.
`The AirFit F20 is:
`•
`to be used by patients weighing more than 66 lb (30 kg) for whom
`positive airway pressure therapy has been prescribed
`intended for single-patient reuse in the home environment and multi-
`patient reuse in the hospital/institutional environment.
`
`•
`
`
`
`
`
` WARNING
`Magnets are used in the lower headgear straps and the frame of the
`AirFit F20. Ensure the headgear and frame is kept at least 2" (50 mm)
`away from any active medical implant (eg, pacemaker or
`defibrillator) to avoid possible effects from localized magnetic fields.
`The magnetic field strength is less than 400 mT.
`Contraindications
`Use of masks with magnetic components is contraindicated in patients
`with the following pre-existing conditions:
`• a metallic hemostatic clip implanted in your head to repair an
`aneurysm
`• metallic splinters in one or both eyes following a penetrating eye
`injury.
`
`
`
`English
`
`1
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`
`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 7
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`

`

` GENERAL WARNINGS
`• The mask must be used under qualified supervision for users who
`are unable to remove the mask by themselves. The mask may not
`be suitable for those predisposed to aspiration.
`• The mask must be fitted with the supplied elbow (containing the
`valve and vent assembly) to ensure safe and functional usage
`unless otherwise specified. Do not use the mask if the valve or
`vent assembly is damaged or missing.
`• The elbow, valve and vent assembly have specific safety
`functions. The mask should not be worn if the valve is damaged
`as it will not be able to perform its safety function. The elbow
`should be replaced if the valve is damaged, distorted or torn. The
`vent holes and valve should be kept clear.
`• The mask should only be used with CPAP or bilevel devices
`recommended by a physician or respiratory therapist.
`• Avoid connecting flexible PVC products (eg, PVC tubing) directly
`to any part of the mask. Flexible PVC contains elements that can
`be damaging to the materials of the mask, and may cause the
`components to crack or break.
`• The mask should not be used unless the device is turned on. Once
`the mask is fitted, ensure the device is blowing air.
`Explanation: CPAP and bilevel devices are intended to be used
`with special masks (or connectors) which have venting to allow
`continuous flow of air out of the mask. When the device is turned
`on and functioning properly, new air from the device flushes the
`exhaled air out through the mask holes. When the device is
`turned off, the mask valve opens to atmosphere allowing fresh air
`to be breathed. However, a higher level of exhaled air may be
`rebreathed when the device is off. This applies to most full face
`masks for use with CPAP and bilevel devices.
`• Follow all precautions when using supplemental oxygen.
`• Oxygen flow must be turned off when the CPAP or bilevel device
`is not operating, so that unused oxygen does not accumulate
`within the device enclosure and create a risk of fire.
`• Oxygen supports combustion. Oxygen must not be used while
`smoking or in the presence of an open flame. Only use oxygen in
`well ventilated rooms.
`
`2
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 8
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`

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`• At a fixed rate of supplemental oxygen flow, the inhaled oxygen
`concentration varies, depending on the pressure settings, patient
`breathing pattern, mask, point of application and leak rate. This
`warning applies to most types of CPAP or bilevel devices.
`• The technical specifications of the mask are provided for your
`clinician to check that they are compatible with the CPAP or
`bilevel device. If used outside specification or if used with
`incompatible devices, the seal and comfort of the mask may not
`be effective, optimum therapy may not be achieved, and leak, or
`variation in the rate of leak, may affect the CPAP or bilevel device
`function.
`• Discontinue using this mask if you have ANY adverse reaction to
`the use of the mask, and consult your physician or sleep therapist.
`• Using a mask may cause tooth, gum or jaw soreness or aggravate
`an existing dental condition. If symptoms occur, consult your
`physician or dentist.
`• The F20 line of full face CPAP masks are not intended to be used
`simultaneously with nebulizer medications that are in the air path
`of the mask/tube.
`• As with all masks, some rebreathing may occur at low CPAP
`pressures.
`• Refer to your CPAP or bilevel device manual for details on
`settings and operational information.
`• Remove all packaging before using the mask.
`
`
`
`Using your mask
`When using your mask with ResMed CPAP or bilevel devices that have
`mask setting options, refer to the Technical specifications section in this
`user guide for the correct setting.
`For a full list of compatible devices for this mask, see the Mask/Device
`Compatibility List on www.resmed.com/downloads/masks. If you do not
`have internet access, please contact your ResMed representative.
`Use a standard conical connector if pressure readings and/or
`supplemental oxygen are required.
`
`
`
`English
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`3
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 9
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`

`

`Fitting
`1. Twist and pull both magnetic clips away from the frame.
`2. Ensure that the ResMed logo on the headgear is facing outwards and
`is upright. With both lower headgear straps released, hold the mask
`against your face and pull the headgear over your head.
`3. Bring the lower straps below your ears, and attach the magnetic clip
`to the frame.
`4. Undo the fastening tabs on the upper headgear straps. Pull the straps
`evenly until the mask is stable and positioned as shown in the
`illustration. Reattach the fastening tabs.
`5. Undo the fastening tabs on the lower headgear straps. Pull the straps
`evenly until the mask is stable and sits comfortably on the chin.
`Reattach the fastening tabs.
`6. Connect the device air tubing to the elbow. Attach the elbow to the
`mask by pressing the side buttons and pushing the elbow into the
`mask, ensuring it clicks in on both sides.
`7. Your mask and headgear should be positioned as shown in the
`illustration.
`
`
`
`Adjustment
`If necessary, slightly adjust the position of the mask for the most
`comfortable fit. Ensure that the cushion is not creased and the headgear
`is not twisted.
`
`
`
`
`
`
`
`
`
`1. Turn on your device so that it is blowing air.
`Adjustment tips:
` With air pressure applied, pull the mask away from your face to
`allow the cushion to inflate and reposition onto your face.
` To resolve any leaks at the upper part of the mask, adjust the
`upper headgear straps. For the lower part, adjust the lower
`headgear straps.
` Adjust only enough for a comfortable seal. Do not overtighten as
`this may cause discomfort.
`Removal
`1. Twist and pull both magnetic clips away from the frame.
`2. Pull the mask away from your face and back over your head.
`
`
`
`
`
`
`
`4
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 10
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`

`

`Disassembly
`If the mask is connected to your device, disconnect the device air tubing
`from the elbow.
`1. Undo the fastening tabs on the upper headgear straps. Pull the straps
`out of the frame.
`Tip: Keep the magnetic clips attached to the lower headgear straps to
`easily distinguish the upper and lower straps when reassembling.
`2. Remove the elbow from the mask by pressing the side buttons and
`pulling the elbow away.
`3. Hold the side of the frame between the upper and lower arms. Gently
`pull the cushion away from the frame.
`
`
`
`Reassembly
`1. Attach the cushion to the frame by aligning the circular openings and
`pushing together until retained.
`2. With the ResMed logo on the headgear facing outside and upright,
`thread the upper headgear straps into the frame slots from the inside.
`Fold them over to secure.
`
`
`
`Cleaning your mask at home
`Handwash your mask and headgear by gently rubbing in warm
`(approximately 86°F/30°C) water using mild liquid detergent. Rinse all
`components well under running water and allow to air dry out of direct
`sunlight.
`
`
`
` WARNING
`• As part of good hygiene, always follow cleaning instructions and
`use a mild liquid detergent. Some cleaning products may damage
`the mask, its parts and their function, or leave harmful residual
`vapours that could be inhaled if not rinsed thoroughly.
`• Regularly clean your mask and its components to maintain the
`quality of your mask and to prevent the growth of germs that can
`adversely affect your health.
`
`
`
`English
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`5
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 11
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`

`

`
`
` CAUTION
`Visible criteria for product inspection: If any visible deterioration of a
`system component is apparent (cracking, discoloration, tears etc.),
`the component should be discarded and replaced.
`Daily/After each use:
`1. Disassemble the mask according to the disassembly instructions.
`2. Rinse the frame, elbow and cushion under running water. Clean with a
`soft brush until dirt is removed.
`3. Soak the components in warm water with a mild liquid detergent for
`up to ten minutes.
`4. Shake the components in the water.
`5. Brush the moving parts of the elbow and around the vent holes.
`6. Brush the areas of the frame where the arms connect, and inside and
`outside the frame where the elbow connects.
`7. Rinse the components under running water.
`8. Leave the components to air dry out of direct sunlight. Make sure to
`squeeze the arms of the frame to ensure that excess water is
`removed.
`
`
`
`Weekly:
`1. Disassemble the mask. The magnets can remain attached to the
`headgear during cleaning.
`2. Handwash the headgear in warm water with mild liquid detergent.
`3. Rinse the headgear under running water. Inspect to ensure the
`headgear is clean and detergent free. Wash and rinse again, if
`necessary.
`4. Squeeze the headgear to remove excess water.
`5. Leave the headgear to air dry out of direct sunlight.
`
`
`
`Reprocessing the mask between patients
`Reprocess this mask when using between patients. Cleaning, disinfection
`and sterilization instructions are available on
`www.resmed.com/downloads/masks. If you do not have internet access,
`please contact your ResMed representative.
`
`
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`6
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 12
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`

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`Troubleshooting
`Problem/possible cause
`Mask is uncomfortable.
`Headgear straps are too tight.
`
`Mask could be the wrong size.
`
`Mask is too noisy.
`Elbow incorrectly installed or incorrect
`assembly of the mask system.
`
`Vent is dirty.
`Mask leaks around the face.
`Cushion membrane is creased. Mask is
`incorrectly positioned or adjusted.
`
`Mask could be the wrong size.
`
`
`
`
`
`Solution
`
`The cushion membrane is designed to inflate
`against your face to provide a comfortable
`seal with low headgear tension. Adjust straps
`evenly. Ensure that the headgear straps are
`not too tight and that the cushion is not
`creased.
`Talk to your clinician to have your face size
`checked against AirFit F20 fitting template.
`Note that sizing across different masks is not
`always the same.
`
`Remove the elbow from your mask, then
`reassemble according to the instructions.
`Check that the mask is correctly assembled
`according to the instructions.
`Use a soft bristle brush to clean the vent.
`
`Refit your mask according to the instructions.
`Ensure that you position the cushion correctly
`on your face before pulling headgear over
`your head. Do not slide the mask down your
`face during fitting as this may lead to
`creasing of the cushion.
`Talk to your clinician to have your face size
`checked against fitting template. Note that
`sizing across different masks is not always
`the same.
`
`English
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`7
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 13
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`

`

`Technical specifications
`Pressure-flow curve
`The mask contains passive venting to protect
`against rebreathing. As a result of manufacturing
`variations, the vent flow rate may vary.
`Flow
`Pressure
`(L/min)
`(cm H2O)
`19
`3
`32
`8
`37
`10
`41
`12
`48
`16
`54
`20
`60
`24
`66
`28
`69
`30
`72
`32
`77
`36
`82
`40
`Physical dead space is the empty volume of the mask to the end
`of the swivel. Using the large cushions it is 240 mL.
`3 to 40 cm H2O
`Drop in pressure measured (nominal)
`at 50 L/min: 0.2 cm H2O
`at 100 L/min: 0.6 cm H2O
`
`
`
`Dead space
`information
`Therapy pressure
`Resistance with
`Anti Asphyxia Valve
`(AAV) closed to
`atmosphere
`Inspiratory and
`expiratory
`resistance with Anti
`Asphyxia Valve
`(AAV) open to
`atmosphere
`
`
`Inspiration at 50 L/min:
`Expiration at 50 L/min:
`
`0.6 cm H2O
`0.7 cm H2O
`
`8
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 14
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`

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`Anti Asphyxia Valve
`(AAV) open-to-
`atmosphere
`pressure
`Anti Asphyxia Valve
`(AAV) closed-to-
`atmosphere
`pressure
`Environmental
`conditions
`
`Sound
`
`Gross dimensions
`
`International
`Commission on
`Non-Ionizing
`Radiation
`Protection (ICNIRP)
`Service life
`
`≤3 cm H2O
`
`≤3 cm H2O
`
`Operating temperature: 41°F to 104°F (5°C to 40°C)
`Operating humidity: 15% to 95% non-condensing
`Storage and transport temperature: -4°F to 140°F (-20°C to +60°C)
`Storage and transport humidity: up to 95% non-condensing
`DECLARED DUAL-NUMBER NOISE EMISSION VALUES in
`accordance with ISO 4871. The A-weighted sound power level of
`the mask is 30 dBA, with uncertainty of 3 dBA. The A-weighted
`sound pressure level of the mask at a distance of 1 m is 23 dBA,
`with uncertainty of 3 dBA.
`Mask fully assembled with elbow assembly (no headgear)
`6.1" (H) x 6.3" (W) x 5.8" (D)
`(154 mm (H) x 159 mm (W) x 147 mm (D))
`Magnets used in this mask are within ICNIRP guidelines for
`general public use.
`
`The service life of the AirFit F20 mask system is dependent on the
`intensity of usage, maintenance, and environmental conditions to
`which the mask is used or stored. As this mask system and its
`components are modular in nature, it is recommended that the
`user maintain and inspect it on a regular basis, and replace the
`mask system or any components if deemed necessary or
`according to the ‘visual criteria for product inspection’ in the
`‘Cleaning your mask at home’ section of this guide. Refer to the
`‘Mask components’ section of this guide for information of how to
`order replacement parts.
`
`English
`
`9
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 15
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`

`

`
`Mask setting options
`
`For AirSense, AirCurve or S9: Select 'Full Face'.
`For other devices: Select 'MIR FULL' (if available), otherwise
`select 'FULL FACE' as the mask option.
`
`
`
`
`
`Notes:
`• This product is not made with PVC or phthalates such as DEHP, DBP
`or BBP.
`• This product is not made with natural rubber latex.
`• The manufacturer reserves the right to change these specifications
`without notice.
`
`
`
`Storage
`Ensure that the mask is thoroughly clean and dry before storing it for any
`length of time. Store the mask in a dry place out of direct sunlight.
`
`
`
`Disposal
`This mask does not contain any hazardous substances and may be
`disposed of with your normal household refuse.
`
`
`
`10
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`
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 16
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`

`

`Symbols
`The following symbols may appear on your product or packaging:
`
`Catalog number
`
`Humidity limitation
`
`Fragile, handle with care
`
`Manufacturer
`
`
`
`Keep away from rain
`
`Full face mask
`
`Size - small
`
`Batch code
`
`Temperature limitation
`
`Not made with natural rubber
`latex
`
`European Authorized
`Representative
`
`This way up
`
`Device setting - Full Face
`
`Size - medium
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Size - large
`
`
`
`
`
`Indicates a Warning or Caution and alerts you to a possible injury or explains
`special measures for the safe and effective use of the device
`
`Caution, consult accompanying documents
`
`Prescription only (In the US, Federal law restricts these devices to sale by or on
`the order of a physician)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`English
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`11
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 17
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`

`

`Limited warranty
`ResMed Ltd (ResMed) warrants that your ResMed mask system
`(including mask frame, cushion, headgear and tubing) will be free from
`defects in material and workmanship from the date of purchase for 90
`days, or in the case of disposable masks and disposable mask
`components for 7 days. This warranty is only available to the initial
`consumer. It is not transferable. If the product fails under conditions of
`normal use, ResMed 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 ResMed 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.
`ResMed will not be responsible for any incidental or consequential
`damages claimed to have resulted from the sale, installation or use of any
`ResMed 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 ResMed
`dealer or ResMed office.
`
`
`12
`
`
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`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 18
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`

`

`Mask components / Composants du masque /
`Piezas de la mascarilla / Componentes da máscara
`AirFit F20
`AirFit F20
`for Her
`—
`
`—
`
`—
`
`—
`
`63467 (S)
`63468 (M)
`63469 (L)
`63473 (Std)
`
`63467 (S)
`63468 (M)
`63469 (L)
`63470 (S)
`63471 (Std)
`63472 (L)
`
`A
`1
`
`2
`
`3
`
`4
`
`B
`
`C
`
`D
`
`5
`
`6
`
`7
`
`Elbow / Coude / Codo / Cotovelo
`Valve (AAV) / Valve (VAA) / Válvula (AAV)
`/ Válvula (VAA)
`Vent / Orifice de ventilation /
`Ventilación / Respiradouro
`Side buttons / Boutons latéraux /
`Botones laterales / Botões laterais
`Swivel / Pièce pivotante /
`Pieza giratoria / Peça giratória
`Frame / Entourage rigide /
`Armazón / Armação
`Cushion / Bulle / Almohadilla /
`Almofada
`
`Headgear / Harnais / Arnés / Arnês
`
`Magnetic clips / Clips magnétiques /
`Broches magnéticos (paquete de /
`Presilhas magnéticas
`Lower headgear straps /
`Sangles inférieures du harnais /
`Correas inferiores del arnés /
`Correias inferiores do arnês
`Upper headgear straps /
`Sangles supérieures du harnais / Correas
`superiores del arnés /
`Correias superiores do arnês
`
`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 19
`
`

`

`AirFit F20
`
`AirFit F20
`for Her
`
`A+B+C
`Frame system / Entourage complet /
`Sistema de armazón /
`Sistema de armação
`A+B+C+D
`Complete system / Masque complet
`/ Sistema completo / Sistema
`completo
`
`63460 (S)
`63461 (M)
`63462 (L)
`
`63400 (S)
`63401 (M)
`63402 (L)
`
`63463 (S)
`63464 (M)
`
`63403 (S)
`63404 (M)
`
`S: Small / Small / Pequeña / Pequeno
`M: Medium / Medium / Mediana / Médio
`L: Large / Large / Grande / Grande
`Std: Standard / Standard / Estándar / Padrão
`
`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 20
`
`

`

`A
`
`B
`
`C
`
`1
`
`2
`
`3
`
`4
`
`D
`
`5
`
`6
`
`7
`
`Distributed by
`ResMed Ltd
`ResMed Corp 9001 Spectrum Center Boulevard San Diego
`1 Elizabeth Macarthur Drive
` ResMed (UK) Ltd 96 Jubilee Ave
`CA 92123 USA
`Bella Vista NSW 2153
`Australia
`Milton Park Abingdon Oxfordshire OX14 4RW UK
`See ResMed.com for other ResMed locations worldwide. AirFit, AirSense and AirCurve are trademarks
`and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property
`information, see ResMed.com/ip. © 2016 ResMed Ltd. 638035/2 2016-11
`
`ResMed.com
`
`638035
`
`Sleep Number Corp. - EXHIBIT 2086 - IPR2019-00514 - Page 21
`
`