AirFit F40 - Respiratory medical device ResMed - Free user manual and instructions

Product Type	Nasal pillows mask for CPAP or bi-level ventilation
Brand	ResMed
Model	AirFit F40
Intended Use	Patients over 30 kg undergoing non-invasive positive pressure therapy
Target Populations	COPD, restrictive syndromes, central respiratory disorders, obstructive sleep apnea, obesity-hypoventilation syndrome
Treatment Pressure	4 to 30 cmH₂O
Resistance with anti-asphyxia valve closed	0.4 cmH₂O at 50 L/min; 1.7 cmH₂O at 100 L/min
Resistance with anti-asphyxia valve open	1.1 cmH₂O at 50 L/min (inhalation and exhalation)
Sound Level (QuietAir vent)	Acoustic power 20 dBA, acoustic pressure 13 dBA
Sound Level (Multi-hole vent)	Acoustic power 34 dBA, acoustic pressure 26 dBA
Operating Temperature	5 °C to 40 °C
Operating Humidity	15 to 95 % RH non-condensing
Storage Temperature	-20 °C to 60 °C
Storage Humidity	95 % RH max non-condensing
Magnetic Field (component surface)	< 400 mT
Magnetic Field (at 50 mm)	< 0.5 mT
Magnetic Components	Rigid frame and lower strap clips
Anti-Asphyxia Valve	Integrated, activates if device airflow is insufficient
Vent Options	QuietAir (silent) vent or Multi-hole vent
Size Options	Cushion Small Wide, Medium, Large; headgear Small, Standard, Large
Daily Cleaning	Cushion, elbow, short tube, vent: warm water + mild detergent
Weekly Cleaning	Headgear and rigid frame
Service Life	Varies by use and maintenance; replace any damaged component
Contraindications	Wearers of active medical implants or ferromagnetic objects (pacemakers, ICDs, etc.)
MRI Compatibility	Not compatible (do not use in an MRI suite)
Warranty	Complies with European Directive 1999/44/EC

Frequently Asked Questions - AirFit F40 ResMed

Which devices are compatible with the AirFit F40 mask?

The mask is compatible with ResMed AirSense, AirCurve, and S9 devices, as well as other CPAP or bi-level devices. Check the compatibility list at ResMed.com/downloads/masks to verify compatibility with your device.

How to properly clean the AirFit F40 mask?

Clean the cushion, elbow, short tube, and vent daily in warm water with mild liquid detergent. Hand wash with a soft-bristle brush, rinse thoroughly, and let dry away from sunlight. Clean the headgear and rigid frame once a week. Do not machine wash or dishwasher.

How to adjust the mask to avoid leaks?

Place the cushion comfortably under the nose, then attach the magnetic clips. For leaks around the nose, reposition the cushion and adjust the upper straps. For leaks around the mouth, adjust the lower straps without overtightening. If leaks persist, check the mask size with your provider.

What are the risks related to the mask magnets?

The magnets in the rigid frame and clips may interfere with active medical implants (pacemakers, ICDs, etc.) or ferromagnetic objects. Maintain a distance of at least 150 mm between the magnets and these devices. Consult your doctor if in doubt.

Can I use the mask with oxygen?

Yes, but take precautions: turn off the oxygen supply when the device is not in use to avoid fire risk. Do not smoke and keep away from naked flames. The inhaled oxygen concentration may vary depending on pressure settings, breathing, and leaks.

How to disassemble and reassemble the mask for cleaning?

Detach the magnetic clips, remove the headgear over the head. For disassembly: disconnect the breathing circuit, detach the tabs of the upper straps, press the side buttons of the elbow, then remove the cushion clip. Follow the reverse order for reassembly, ensuring the vent is properly engaged.

What is the service life of the AirFit F40 mask?

The service life depends on use, maintenance, and storage conditions. Regularly inspect components and replace them when signs of wear appear (cracks, tears). Follow cleaning frequencies to extend the lifespan.

Is the mask MRI compatible?

No, the mask contains magnetic components and should not be used in an MRI environment. It must remain outside the MRI room.

What to do in case of skin reaction or irritation?

If you develop redness, irritation, or any adverse reaction, stop using the mask and consult your doctor or a sleep specialist. Do not overtighten the headgear to avoid skin marks.

How to choose the right cushion and headgear size?

The mask is available in Small Wide, Medium, and Large cushion sizes, and Small, Standard, and Large headgear sizes. Ask your doctor or provider to verify the correct size for your face. Incorrect size can cause leaks and discomfort.

USER MANUAL AirFit F40 ResMed

A curved dotted line with black dots, resembling a stylized wave or curve (no text or symbols)

ResMed

AirFit™

Full face mask

Full face mask

Pillows Mask Setting

User guide

English | Deutsch | Français | Italiano | Nederlands Dansk | Suomi | Norsk | Svenska | Português | Español Polski | Česky | العربية | نيسي | اردو

Not all products are available in all regions

A Elbow and short tube
B Frame
C Cushion
D Headgear
1 Anti-asphyxia valve (AAV)
2 Side button
3 Frame stud hole
4 Frame magnet
5 QuietAir ^TM vent ring
6 Multi-hole vent ring
7 Cushion stud
8 Magnetic clip
9 Lower headgear strap
10 Upper headgear strap
11 Top headgear strap

Intended use

The AirFit F40 is intended for patients weighing more than 30 kg, who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. It is intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

Contraindications

Masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have the following:

• Active medical implants that interact with magnets (ie, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
• Metallic implants/objects containing ferromagnetic material (ie, aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye).

WARNING

Keep the mask magnets at a safe distance of at least 6" (150 mm) away from implants or medical devices that may be adversely affected by magnetic interference. This warning applies to you or anyone in close physical contact with your mask. The magnets are in the frame and lower headgear clips, with a magnetic field strength of up to 400 mT. When worn, they connect to secure the mask but may inadvertently detach while asleep.

Implants/medical devices, including those listed within contraindications, may be adversely affected if they change function under external magnetic fields or contain ferromagnetic materials that attract/repel to magnetic fields (some metallic implants, eg, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices). Consult your physician and manufacturer of your implant/other medical device for information on the potential adverse effects of magnetic fields.

Clinical benefits

The clinical benefit of vented masks is the provision of effective therapy delivery from a therapy device to the patient.

Intended patient population/medical conditions

Obstructive pulmonary diseases (eg, Chronic Obstructive Pulmonary Disease), restrictive pulmonary diseases (eg, diseases of the lung parenchyma, diseases of the chest wall, neuromuscular diseases), central

respiratory regulation diseases, obstructive sleep apnoea (OSA) and obesity hypoventilation syndrome (OHS).

WARNING

- The mask contains safety features, the exhaust vent holes and anti-asphyxia valve, to enable normal breathing and exhaust exhaled breath. Occlusion of the exhaust vent holes or anti-asphyxia valve needs to be prevented to avoid having an adverse effect on the safety and quality of the therapy. Regularly inspect the vent holes and anti-asphyxia valve to ensure they are kept clean, clear of blockages and are not damaged.

- Only use compatible CPAP or bi-level therapy devices or accessories. The technical specifications of the mask are provided for healthcare professionals to identify compatible devices. Use in combination with incompatible medical devices can decrease the safety or alter the performance of the mask.

- 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.

- 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 prone to aspiration.

- Discontinue using or replace this mask if the patient has ANY adverse reaction to the use of the mask. Consult your physician or sleep therapist.

- 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.

- 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.

WARNING

• If there is any visible deterioration of a mask component (cracking, crazing, tears etc.) the component should be discarded and replaced.
• The mask is Magnetic Resonance (MR) unsafe and must be kept outside of MRI scanner rooms.
• Always follow cleaning instructions and only use a mild liquid detergent. Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapours. Do not use a dishwasher or washing machine to clean the mask. Ozone or UV light products have not been validated for use with the mask and may lead to discoloration or damage.
• The mask is not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.
• For any serious incidents that occur in relation to this device, these should be reported to ResMed and the competent authority in your country.

CAUTION

• When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
• 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 mask should not be used unless the device is turned on. Once the mask is fitted, ensure the device is blowing air to reduce risk of rebreathing exhaled air.
• As with all masks, some rebreathing may occur at low pressures.
• Do not iron the headgear as the material is heat sensitive and will be damaged.

Fitting your mask

Remove all packaging before using the mask.

Illustration of a person wearing a respirator mask and head cover, with a hand adjusting the mask (no text or symbols present)

1. Twist and pull both magnetic clips away from the frame magnets.
2. Place the cushion under your nose and ensure it sits comfortably against your face. With the ResMed logo on the headgear facing out, pull the headgear over your head. The top headgear strap should sit on top of your head and not too far forward or back.
3. Bring the lower headgear straps under your ears and attach the magnetic clips to the frame.
4. If the mask needs adjusting, undo the fastening tabs on the upper headgear straps and pull evenly. Repeat with the lower headgear straps.

Mask setting options

Ensure that Pillows is selected in the mask setting options of your ResMed device. For a full list of compatible devices for this mask, see the Mask/Device Compatibility List at

ResMed.com/downloads/masks.

Adjusting your mask

• With the device turned on and blowing air, adjust the position of the cushion for the most comfortable fit under your nose. Ensure that the cushion is not creased and the headgear is not twisted.
• The top headgear strap should sit on top of your head and not too far forward or back. Reposition the strap if needed to ensure the cushion has a good seal under the nose.
• To fix any leaks around the nose, pull the cushion slightly away from the face and reposition the cushion so that it sits comfortably under the nose. Adjust the upper headgear straps, if required.
• To fix any leaks around the mouth, adjust lower headgear straps. Adjust only enough for a comfortable seal and do not overtighten.
• If you continue to have leaks around the face, you may have the wrong mask size. Talk to your clinician to have your mask size checked. Note that sizing across different masks is not always the same.

Scan this QR code with your mobile device or visit ResMed.com/downloads/masks for helpful documents and support videos for your mask.

Removing your mask

Illustration of a person using a respirator mask and cap, with arrows indicating motion (no text or symbols)

1. Twist and pull both magnetic clips away from the frame magnets.
2. Pull the mask away from your face and back over your head.

Disassembling your mask for cleaning

If your mask is connected to a device, disconnect the device air tubing from the short tube.

1. Undo the fastening tabs on the upper headgear straps and pull from the frame.
   Tip: Keep the magnetic clips attached to the lower headgear straps to easily distinguish the upper and lower straps when reassembling.
2. Squeeze the side buttons on the elbow and detach from the vent ring.
3. Pull the cushion stud out of the frame stud hole, repeat on the other side.
4. Pull the vent ring from the cushion.

Cleaning your mask

If there is any visible deterioration of a mask component (cracking, crazing, tears etc.) the component should be discarded and replaced.

Daily/After each use: Cushion, elbow and short tube, vent ring

Weekly: Headgear, frame

1. Soak the components in warm water with a mild liquid detergent. Ensure that there are no air bubbles while soaking.
2. Shake the components vigorously in the water and hand wash with a soft bristle brush. Pay particular attention to the vent holes in the QuietAir/Multi-hole vent ring.
3. Thoroughly rinse the components under running water.
4. Squeeze the fabric components to remove excess water.
5. Leave the components to air dry out of direct sunlight.

If the mask components are not visibly clean, repeat the cleaning steps. Make sure that the vents and anti-asphyxia valves are clean and clear.

Reassembling your mask

Illustration of hands performing a medical procedure on a wrist (no text or symbols visible)

1. Insert the cushion stud into the frame stud hole. Repeat on the other side.
2. Align the vent ring groove against the cushion opening. Press firmly to secure in place and ensure that the cushion opening sits into the vent ring groove.
3. Connect the elbow to the vent ring.
4. With dark grey fabric side facing inwards, insert both upper headgear straps into the frame from the inside and fold the fastening tabs over to secure.

Reprocessing the mask between patients

When using between patients, these masks must be reprocessed according to instructions available on ResMed.com/downloads/masks.

Technical specifications

Mask setting options: For AirSense™, AirCurve™, and S9™ devices, select 'Pillows'.

Compatible devices: For a full list of compatible devices for this mask, see the Mask/Device Compatibility List at ResMed.com/downloads/masks.

SmartStart may not operate effectively when using this mask with some CPAP or bi-level devices.

Pressure-flow curve

Pressure (cm H2O)	Flow (L/min)
4	20
11	35
17	44
24	54
30	61

Therapy pressure: 4 to 30 cmH _2 O

Resistance with Anti-Asphyxia Valve closed to atmosphere

Drop in pressure measured (nominal)

at 50 L/min: 0.4 cmH₂O

at 100 L/min: 1.7 cmH₂O

Resistance with Anti-Asphyxia Valve open to atmosphere

Inspiration at 50 L/min: 1.1 cmH₂O

Expiration at 50 L/min: 1.1 cmH2O

Anti-Asphyxia Valve pressure

open-to-atmosphere (activation): <4 cmH₂O

closed-to-atmosphere (deactivation): <4 cmH2O

Sound: Declared dual-number noise emission values in accordance with ISO4871:1996

and ISO3744:2010. A-weighted sound power level with uncertainty of 3dBA and

A-weighted pressure level at a distance of 1 m with uncertainty of 3 dBA are shown:

Sound power level (with QuietAir vent ring): 20 dBA

Pressure level (with QuietAir vent ring): 13 dBA

Sound power level (with Multi-hole vent ring): 34 dBA

Pressure level (with Multi-hole vent ring): 26 dBA

Environmental conditions

Operating temperature: 5°C to 40°C

Operating humidity: 15% to 95% RH non-condensing

Storage and transport temperature: -20°C to 60°C

Storage and transport humidity: up to 95% RH non-condensing

International Commission on Non-Ionizing Radiation Protection (ICNIRP)

Magnets used in this mask are within ICNIRP guidelines for general public use. The static magnetic field strength is less than 400 mT at component surface and less than 0.5 mT at 50 mm distance.

Service life: The service life of the 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 instructions in the ‘Cleaning your mask’ section of this guide.

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 and packaging do not contain any hazardous substances and may be disposed of with your normal household refuse.

Symbols

The following symbols may appear on your product or packaging:

See symbols glossary at ResMed.com/symbols.

Consumer Warranty

ResMed acknowledges all consumer rights granted under the EU Directive 1999/44/EC and the respective national laws within the EU for products sold within the European Union.

Illustration of a hand adjusting a mechanical component with a knob and threaded shaft (no text or symbols)

Illustration of a person wearing a full-face respirator mask and head cover, with a hand adjusting the mask (no text or symbols present)

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(International Commission on Non-Ionizing Radiation Protection – ICNIRP)

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Illustration of a person wearing a full-face respirator mask and head cover, with a hand adjusting the mask (no text or symbols present)

Pillows Mask Setting

ResMed.com/downloads/masks.

Illustration of a person using a respirator device with arrows indicating airflow direction (no text or symbols)

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Courbe pression/débit

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Pillows
Mask Setting

Cuscinetto Small Wide

Cuscinetto Medium

Cuscinetto Large

Copricapo Small

Copricapo Standard

Copricapo Large

Esalazione QuietAir

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Illustration of a person using a respirator device (no text or symbols visible)

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Pillows Mask Setting

ResMed.com/downloads/maskers.

Uw masker aanpassen

Illustration of a person wearing a respirator mask and head cover, with arrows indicating airflow direction (no text or symbols)

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open (activering): < 4 cmH₂O

gesloten (deactivering): < 4 cmH₂O

Illustration of a hand adjusting a mechanical component with a tool, no text or symbols present

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Pillows Mask Setting

ResMed.com/downloads/masks.

Justering af masken

Illustration of a person using a respirator mask and cap, with arrows indicating motion (no text or symbols)

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Mechanical assembly diagram showing a hand operating a valve with a close button (no text or symbols)

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Mechanical assembly diagram showing a hand operating a valve with a close button (no text or symbols)

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International Commission on Non-Ionizing Radiation Protection (ICNIRP)

5 QuietAir™ ventilring

6 Multi-hole ventilring

7 Putetapp

8 Magnetklips

9 Nedre hodestropp

10 ∅vre hodestropp

11 ∅verste hodestropp

Tiltenkt bruk

Pillows Mask Setting

ResMed.com/downloads/masks.

Justere masken

Illustration of a person using a respirator mask and cap (no text or symbols)

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Komponenten er resirkulerbar. Sorteres til resirkulering.

Ikke laget med naturgummilateks

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Pillows Mask Setting

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International Commission on Non-Ionizing Radiation Protection (ICNIRP)

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Pillows Mask Setting

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Pillows Mask Setting

Illustration of a person using a respirator device with arrows indicating airflow direction (no text or symbols)

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International Commission on Non-Ionizing Radiation Protection (ICNIRP)

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Illustration of a person wearing a full-face respirator mask and headlamp, with a hand adjusting the mask (no text or symbols present)

Pillows Mask Setting

ResMed.com/downloads/masks.

Seřízení masky

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Pillows Mail Tasting

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Pillows Mass Setting

ماسک تمام صورت

Full Face Mask

بالشتك متوسط

بالشتك پهن كوجك

سربند کوچک

بالشتك بزرگ

سربند بزرگ

سربند استاندارد

نامن MR

WITH NATURAL RUBBER LATEX

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Illustration of hands adjusting a mechanical component with a tool (no text or symbols visible)

Illustration of hands adjusting a mechanical component with an arrow indicating motion (no text or symbols present)

Illustration of a hand using a medical or surgical instrument to adjust a device (no text or symbols visible)

Illustration of hands using a tool to adjust or install a mechanical component, with no visible text or symbols.

Illustration of hands assembling a mechanical component with an arrow indicating motion (no text or symbols present)

Illustration of hands performing a medical procedure on a patient's arm (no text or symbols visible)

.1. 2. 3. 4.

.ResMed.com/downloads/masks-1

בְרָה בַרִי

AirSense™, AirCurve™, and S9™ .(הכלה) 'Pillows' (הכלה) (הכלה) ,הכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכלההכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia/הכchia

הכלה-הכלההוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָהוּרָה

(ICNIRP)

Pillovas Marsh Setting

הכלהה

Full Face Mark

תְבָרִי בְּרִי

Illustration of a person wearing a respirator mask and headlamp (no text or symbols)

Illustration of a hand adjusting a mechanical component with a circular arrow indicating rotation (no text or symbols present)

Line drawing of a person wearing a full-face respirator mask and headband (no text or symbols)

Illustration of hands assembling a mechanical component with an arrow indicating assembly (no text or symbols present)

Illustration of a hand using a tool to interact with a mechanical device (no text or symbols visible)

Illustration of hands performing a manual switch or grip operation (no text or symbols present)

Illustration of hands using a tool to adjust or install a mechanical component (no text or symbols visible)

Illustration of hands assembling a mechanical component with a numbered label (3), no text or symbols present.

Illustration of hands assembling a mechanical component with a tool (no text or symbols visible)

Illustration of hands performing a mechanical press or disassembly operation on a cylindrical component (no text or symbols visible)

1. بِدْ كَيْر كى بالانى پُتى پر باندهنى والى ئَيْبِز كَهولیين اور فريم سە دور کهینج لین. تجويز: م Concentطيسى کلپس کو بِدْ كَيْر كى نچلى پُتى كى ساتەه منسلک ركهین تاکد دوباره جورتى بونى بالانى اور نچلى پُتى مین آسانى سە فرق بو سکى.

2. ایلیو پر م baggageد سائیک بتنز کو سختی کے ساته دبائین اور وینک رنگ سے علیدده کرین.

3. کُشن استنّ کو فریم استنّ بول سے بابر نکالین، دوسری جانب بهی يپی عمل دېرانین.
4. کُشن سے وینک رنگ کو بابر کهینچ لین.

Illustration of hands assembling a mechanical component with an arrow indicating direction (no text or symbols)

Illustration of hands fastening a mechanical component with a tool (no text or symbols visible)

Illustration of hands performing a manual task on a mechanical component, no text or symbols present

Illustration of a hand adjusting a medical device with a cross symbol (no text or labels)

Illustration of hands using a tool to adjust or install a mechanical component, with no visible text or symbols.

Illustration of hands assembling a mechanical component with an arrow indicating motion (no text or symbols present)

Illustration of hands performing a medical procedure on a patient's arm, showing finger placement and a curved arrow (no text or symbols)

Simple curved dotted line with black dots, no text or symbols present

ResMed

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See ResMed.com for other ResMed locations worldwide. AirFit, AirCurve, AirSense, QuietAir and S9 are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. © 2023 ResMed. 638361/1 2023-11