2ACHL-AIR11M1G22Continuous Positive Airway Pressure (CPAP) Device

User guide English | Français | Español | Português User guide 398133 Pacific Cover CMYK_Muti_FPL.indd 2398133 Pacific Cover CMYK_Muti_FPL.indd 29/11/2021 2:20:09 PM9/11/2021 2:20:09 PM 398133 Pacific Cover CMYK_Muti_FPL.indd 3398133 Pacific Cover CMYK_Muti_FPL.indd 39/11/2021 2:20:09 PM9/11/2021 2:20:09 PM i ENGLISH Contents Welcome ........................................................................................................................................... 1 Indications for use ...................................................................................................................... 1 Contraindications ........................................................................................................................ 1 Adverse effects .......................................................................................................................... 1 Software functionality and device data ............................................................................................ 2 At a glance ........................................................................................................................................ 3 About your device ............................................................................................................................. 4 Setting up your device ...................................................................................................................... 5 Navigating the touch screen ............................................................................................................. 7 Additional features ..................................................................................................................... 8 Connecting your AirSense 11 device and smart device ........................................................... 9 Starting/Stopping therapy .............................................................................................................. 10 About the heated tubing ................................................................................................................. 11 Therapy data ................................................................................................................................... 12 Cleaning and caring for the device ................................................................................................. 14 Disassembling .......................................................................................................................... 15 Cleaning .................................................................................................................................... 15 Checking ................................................................................................................................... 16 Replacing the air filter .............................................................................................................. 16 Reassembling ........................................................................................................................... 17 Traveling ......................................................................................................................................... 17 Traveling by plane..................................................................................................................... 17 Troubleshooting.............................................................................................................................. 18 General warnings ............................................................................................................................ 20 Technical specifications .................................................................................................................. 21 Symbols .......................................................................................................................................... 25 Servicing ......................................................................................................................................... 26 Limited warranty ............................................................................................................................. 26 Further information......................................................................................................................... 27 ii Quick setup view Components 1. HumidAir™ 11 tub 2. AirSense™ 11 device 3. Power supply unit 4. ClimateLineAir™ 11 tubing 5. Mask English 1 Welcome The AirSense 11 AutoSet™ (including AutoSet for Her) device is ResMed's premium auto-adjusting pressure device. The AirSense 11 Elite and the AirSense 11 CPAP are ResMed's Continuous Positive Airway Pressure (CPAP) devices. WARNING • Read this entire guide before using the device. • This device is not suitable for ventilator-dependent patients. CAUTION In the US, Federal law restricts this device to sale by or on the order of a physician. Indications for use AirSense 11 AutoSet (including AutoSet for Her) The AirSense 11 self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg), including female patients with mild to moderate OSA in AutoSet for Her mode. The AirSense 11 self-adjusting system is intended for home and hospital use. AirSense 11 CPAP (including Elite) The AirSense 11 CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). The AirSense 11 CPAP system is intended for home and hospital use. Contraindications Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing conditions: • severe bullous lung disease • pneumothorax or pneumomediastinum • pathologically low blood pressure, particularly if associated with intravascular volume depletion • dehydration • cerebrospinal fluid lea…

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1 Addendum ENGLISH FCC information This document provides additional information regarding compliance of the AirSense 11 device with FCC Rules and Industry Canada Rules. FCC ID 4G/3G: 2ACHL-AIR114G FCC ID LTE Cat-M1: 2ACHL-AIR11M1 FCC ID LTE Cat-M1/BG22: 2ACHL-AIR11M1G22 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: • This device may not cause harmful interference • This device must accept any interference received, including interference that may cause undesired operation. This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF energy) set by the Federal Communications Commission of the U.S Government and Industry Canada. The exposure standard employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit relevant for the application described in the manual is 1.6W/kg. Tests for SAR are conducted using standard operating positions accepted by the FCC with the device transmitting at its highest certified power level in all tested frequency bands. Although the SAR is determined at the highest certified power level, the actual SAR level of the equipment while operating can be well below the maximum value. This is because the device is designed to operate at multiple power levels so as to use only the power required to reach the network. In general, the closer you are to a wireless base station antenna, the lower the power output. Equipment Authorization has been granted to this model with the reported SAR level(s) evaluated as in compliance with the FCC RF exposure guidelines. SAR information on this equipment is on file with the FCC and can be found under the Display Grant section of www.fcc.gov/oet/ea/fccid after searching on the FCC ID as printed on the equipment. The AirSense 11 device should be installed and operated with minimum distance of 0.59" (15 mm) between the equipment and the user's body. This device complies with the FCC radiation exposure limits set forth in an uncontrolled environment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try 2 to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna • Increase the separation between the equipment and receiver • Connect the equipment into an outlet on a circuit different to that which the receiver is connected • Consult the dealer or an experienced radio/TV techinican for help. Any change or modification to the product is not expressly approved by ResMed and could void the user's authority to operate the device. Industry Canada IC ID 4G/3G: 9103A-AIR114G IC ID LTE Cat-M1: 9103A-AIR11M1 IC ID LTE Cat- M1/BG22: 9103A-AIR11M1G22 This device complies with Industry Canada Rules. Operation is subject to the following two conditions: • This device may not cause interference • This device must accept any interference, including interference that may cause undesired operation. The device has been designed to comply with safety standards for exposure to radio waves (SAR) in accordance to RSS-102. FRANÇAIS Renseignements relatifs à la FCC Le présent document fournit des renseignements complémentaires relatifs à la conformité de l’appareil AirSense 11 aux règlements de la FCC et d’Industrie Canada. ID DE LA FCC ID 4G/3G: 2ACHL-AIR114G ID DE LA FCC LTE Cat-M1: 2ACHL-AIR11M1 ID DE LA FCC LTE Cat-M1/BG22: 2ACHL-AIR11M1G22 Cet appareil est conforme à la Section 15 des règlements de la FCC. Son fonctionnement est soumis aux deux conditions suivantes : • Cet appareil ne doit pas causer de brouillage préjudiciable, • Cet appareil doit accepter tout brouillage subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. Cet appareil est conçu et fabriqué afin de ne pas dépasser les limites d’émission pour une exposition aux fréquences radio (énergie RF) telles qu’établies par la Commission fédérale des communications du gouvernement des États-Unis (FCC) et par Industrie Canada. La norme d’exposition est fondée sur une unité de mesure appelée Débit d’absorption spécifique ou SAR (Specific Absorption Rate). Le SAR limite correspondant à l’utilisation décrite dans le manuel est de 1,6 W/kg. Les tests portant sur le SAR sont effectués en utilisant les positions de fonctionnement standard acceptées par la FCC lorsque l’appareil fonctionne à son niveau de puissance certifié le plus élevé dans toutes les bandes de fréquences testées. Bien que le SAR soit déterminé au niveau de puissance certifié le plus élevé, le niveau de SAR réel de l’appareil en cours d’utilisation peut être nettement inférieur à la valeur maximale. Cela est dû au fait que l’appareil est conçu pour fonctionner à différents niveaux de puissance de manière à n’utiliser que la puissance nécessaire pour atteindre le réseau. Généralement, plus vous êtes proche d’une antenne de station de base sans fil, plus la puissance de sortie est faible. ResMed.com La FCC a accordé une autorisation de commercialisation de ce modèle d’appareil, confirmant la conformité des niveaux SAR évalués avec les directives de la FCC relatives à l’exposition aux RF. Les renseignements relatifs au SAR pour cet appareil sont conservés par la FCC et se trouvent dans la section Display Grant (Afficher l’autorisation) du site www.fcc.gov/oet/ea/fccid a…

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Cellular Information Guide ENGLISH Cellular module Technology used: Frequencies (MHz)* Max RF power output (dBm) 2G 900/ 1800 33.0 3G 850/ 900/ AWS/ 1900/ 2100 23.5 4G LTE Cat-1 700/ 800/ 850/ AWS/ 1800/ 1900/ 2100 23.0 LTE Cat-M1 700/ 800/ 850/ 900/ 1700/ AWS/ 1800/ 1900/ 2100 20.0 *Bands may not be available in all regions. FCC ID - 4G/3G: 2ACHL-AIR114G IC ID - 4G/3G: 9103A-AIR114G FCC ID - LTE Cat-M1: 2ACHL-AIR11M1 IC ID – LTE Cat-M1: 9103A-AIR11M1 FCC ID – LTE Cat-M1/BG22: 2ACHL-AIR11M1G22 IC ID – LTE Cat-M1/BG22: 9103A-AIR11M1G22 The AirSense™11 device complies with FCC Rules and Industry Canada rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference; and 2. This device must accept any interference received, including interference that may cause undesired operation. The device should be installed and operated with minimum distance 0.59" (15 mm) between the equipment and the user's body. Additional information regarding the FCC Rules and IC compliance for this device can be found on ResMed.com/downloads/devices In Canada, the device has been designed to comply with safety standards to radio waves (SAR) in accordance to RSS-102. FRANÇAIS Module cellulaire Technologie utilisée: Fréquences (MHz)* Puissance de sortie RF max. (dBm) 2G 900/1800 33,0 3G 850/900/AWS/1900/2100 23,5 4G LTE Cat.-1 700/800/850/AWS/1800/1900/2100 23,0 LTE Cat.-M1 700/800/850/900/1700/AWS/1800/1900/2100 20,0 *Les bandes sont susceptibles de ne pas être disponible dans toutes les régions. Identifiant FCC — 4G/3G : 2ACHL-AIR114G ID IC — 4G/3G : 9103A-AIR114G Identifiant FCC — LTE Cat-M1 : 2ACHL-AIR11M1 ID IC — LTE Cat-M1: 9103A-AIR11M1 Identifiant FCC — LTE Cat-M1/BG22: 2ACHL-AIR11M1G22 ID IC — LTE Cat-M1/BG22: 9103A-AIR11M1G22 L’appareil AirSense11 est conforme aux règlements de la FCC et d’Industrie Canada. Son fonctionnement est soumis aux deux conditions suivantes : 1. Cet appareil ne doit pas causer de brouillage préjudiciable, et 2. Cet appareil doit accepter tout brouillage subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. L’appareil doit être installé et utilisé avec une distance minimale 0,59 po (15 mm) entre l’équipement et le corps de l’utilisateur. Le site ResMed.com/downloads/devices contient des renseignements supplémentaires au sujet de l’observance des règlements de la FCC et d’IC applicables à ce dispositif Au Canada, cet appareil a été conçu pour respecter les normes de sécurité relatives aux ondes radioélectriques (DAS) conformément à la norme RSS-102. ESPAÑOL Módulo celular Tecnología utilizada: Frecuencias (MHz)* Salida de potencia máxima de RF (dBm) 2G 900/1800 33.0 3G 850/900/AWS/1900/2100 23.5 4G LTE Cat.-1 700/800/850/AWS/1800/1900/2100 23.0 LTE Cat.-M1 700/800/850/900/1700/AWS/1800/1900/2100 20.0 *Es posible que las bandas no estén disponibles en todas las regiones. Identificación de la FCC - 4G/3G: 2ACHL-AIR114G Identificación de IC - 4G/3G: 9103A-AIR114G Identificación de la FCC – LTE Cat-M1: 2ACHL-AIR11M1 Identificación de IC – LTE Cat-M1: 9103A-AIR11M1 Identificación de la FCC – LTE Cat-M1/BG22: 2ACHL-AIR11M1G22 Identificación de IC – LTE Cat-M1/BG22: 9103A-AIR11M1G22 El dispositivo AirSense11 cumple con las reglas de la FCC y las reglas de Industry Canada. El funcionamiento está sujeto a las dos condiciones siguientes: 1. Este dispositivo no puede causar interferencias perjudiciales; y 2. Este dispositivo debe aceptar cualquier interferencia recibida, incluidas las interferencias que puedan provocar un funcionamiento no deseado. El dispositivo debe instalarse y operarse con una distancia mínima 0.59" (15 mm) entre el equipo y el cuerpo del usuario. Puede encontrarse más información sobre el cumplimiento con la IC y las normas de la FCC pertinentes a este dispositivo en www.ResMed.com/ProductSupport. En Canadá, el dispositivo se ha diseñado para cumplir con los estándares de seguridad para ondas de radio (SAR) de acuerdo con RSS-102. PORTUGUÊS (BRASIL) Módulo celular Tecnologia usada: Frequências (MHz)* Potência máxima de saída RF (dBm) 2G 900/1800 33,0 3G 850/900/AWS/1900/2100 23,5 4G LTE Cat-1 700/800/850/AWS/1800/1900/2100 23,0 LTE Cat-M1 700/800/850/900/1700/AWS/1800/1900/2100 20,0 *As bandas podem não estar disponíveis em todas as regiões. FCC ID - 4G/3G: 2ACHL-AIR114G ID IC - 4G/3G: 9103A-AIR114G FCC ID – LTE Cat-M1: 2ACHL-AIR11M1 ID IC – LTE Cat-M1: 9103A-AIR11M1 FCC ID – LTE Cat-M1/BG22: 2ACHL-AIR11M1G22 ID IC – LTE Cat-M1/BG22: 9103A-AIR11M1G22 O dispositivo AirSense11 atende às normas da FCC e da Industry Canada. O funcionamento está sujeito às duas seguintes condições: 1. Este dispositivo não pode causar interferência prejudicial; e 2. Este dispositivo deve aceitar qualquer interferência recebida, incluindo as que possam causar funcionamento indesejado. O dispositivo deve ser instalado e operado com uma distância mínima 0,59 pol. (15 mm) entre o equipamento e o corpo do usuário. Informações adicionais relacionadas às normas da FCC e compatibilidade com a IC para este dispositivo podem ser encontradas em ResMed.com/downloads/devices No Canadá, o dispositivo foi projetado para atender às normas de segurança para ondas de rádio (SAR), de acordo com a RSS-102. ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia See ResMed.com for other ResMed locations worldwide. Air11 and AirSense are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. © 2022 ResMed. 398138/2 2022-09

ResMed Pty Ltd 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia T +61 2 8884 1000 E [email protected] ResMed.com Date: 25-Oct-2022 DECLARATION OF EQUIVALENCE This document declares that the following designated products are equivalent to the unit under test 39485. Model Name / Product Code Marketing Name 39517 AirSense 11 AutoSet USA 39518 AirSense 11 CPAP USA 39519 AirSense 11 Elite USA 39520 AirSense 11 AutoSet CAN 39521 AirSense 11 CPAP CAN 39522 AirSense 11 Elite CAN All the above stated products and the unit under test - 39485 have the same cellular hardware and firmware. Applicant: Company Name: ResMed Pty Ltd Address: 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153 Australia By, ____________________ Christopher Jenkins Title: Manager – Systems Engineering Company: ResMed Pty Ltd Telephone: +61 2 8884 1517 e-mail: [email protected]

AIRSENSE 11 – US VARIANTS – SIMILARITIES AND DIFFERENCES FOR PACIFIC PROJECT ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way. © ResMed Ltd 2022 Date last saved: 29-Nov-22Objective id: A11_TT_M1_US_Similarities & Differences Page 1 of 2 Title: AIRSENSE 11- US VARIANTS – SIMILARITIES AND DIFFERENCES Project/Product PACIFIC AIRSENSE 11 – US VARIANTS – SIMILARITIES AND DIFFERENCES FOR PACIFIC PROJECT Company Confidential Date last saved: 29-Nov-22Objective id: A11_TT_M1_US_Similarities & Differences Page 2 of 2 1. Purpose This document discusses the similarities and differences between US variants of the AirSense 11 project applicable to the following device models: Model Name / Product Code Marketing Name 39517 AirSense 11 AutoSet USA 39518 Airsense 11 CPAP USA 39519 AirSense 11 Elite USA 39520 AirSense 11 AutoSet CAN 39521 AirSense 11 CPAP CAN 39522 AirSense 11 Elite CAN 2. Equivalence All the device models mentioned in Section 1 have the following same components/parts: • Hardware o Cellular o Bluetooth o Flow Generator • Software o Cellular o Bluetooth o Flow Generator • Device Colour (paint) 3. Differences Different models are derived for marketing purposes. The difference between Elite, AutoSet, and CPAP models are the therapy modes they support, whereas different variants of AutoSet, Elite, and CPAP are based on the customer centric features supported by the device. These settings are configured at manufacturing via a configuration file and is independent of the cellular, Bluetooth and FG software. In summary, the differences between the device models mentioned in Section 1 are: • Therapy modes • Data settings • UI language • Name plaque

ResMed Pty Ltd 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia T +61 2 8884 1000 E [email protected] ResMed.com Date: 26-Oct-2022 DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía C/ Severo Ochoa 2 & 6 29590 Campanillas Málaga, España Ref: Confidentiality request for FCC ID: 2ACHL-AIR11M1G22 To whom it may concern: Pursuant to §0.457(d)(1)(ii) and §0.459 of the Commission’s Rules (47 C.F.R.) and §552 (b)(4) of the Freedom of Information Act, ResMed Pty Ltd hereby request requests that a part of the subject FCC application be held confidential to avoid release of sensitive information of the product to the public. For the product stated above, we request that the following information be withheld from public disclose: Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term External Photos Short Term Internal Photos Short Term Permanent Operation Description Short Term Permanent Parts List & Placement/BOM Short Term Permanent Tune-Up Procedure Short Term Permanent Schematics Short Term Test Setup Photos Short Term User’s Manual Permanent Confidentiality: The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to us and provide unjustified benefits to our competitors. Short-Term Confidentiality: We hereby request short-term confidentiality for the product stated above to avoid premature release of sensitive information prior to marketing or release of the product to the public. Release date of short term confidentiality is: 45 days from grant date marked 90 days from grant date marked 135 days from grant date marked 180 days from grant date marked Specific date: We are also aware that we are responsible to notify DEKRA in the event information regarding the product or the product is made available to the public. DEKRA will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Sincerely, _________________________ By: Christopher Jenkins Title: Manager – Systems Engineering Company: ResMed Pty Ltd Telephone: +61 2 8884 1000 e-mail: [email protected]

ResMed Pty Limited 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia T +61 (2) 8884 1000 F +61 (2) 8884 2000 E [email protected] ABN 30 003 765 142 ResMed.com Date: 17-Nov-2022 DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía C/ Severo Ochoa 2 & 6 29590 Campanillas Málaga, España Ref: Agent letter for FCC ID: 2ACHL-AIR11M1G22 We, ResMed Pty Ltd, 1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, Australia hereby authorize DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía C/ Severo Ochoa nº 2 29590 Campanillas - Malaga Spain Agent: Mario Baudet Aranda e-mail: [email protected] Phone: +34 952 61 93 71 to act as our agent in the preparation of this application for equipment certification, including the signing of all documents relating to these matters. The present authorization considers the development of documents on behalf of the client, written under client’s own letterhead and related to the necessary information to be provided on client’s behalf to complete the certification process. We also hereby certify that neither we nor any party to this application are subject to a denial of U.S. Federal benefits, which include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, U.S.C. 862 because of conviction for possession or distribution of controlled substance. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by DEKRA Testing and Certification, S.A.U., still resides with us. This agreement expires one year from the current date. Sincerely, _____________________ Christopher Jenkins Title: Manager – Systems Engineering Company: ResMed Pty Ltd Telephone: +61 2 8884 1517 e-mail: [email protected]

AIRSENSE 11 EXTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way.  ResMed Ltd 2022 Date last saved: 1-Nov-22Objective id: 72943_72944_A11_P3.10_M1_US_External PhotographsPage 1 of 5 Title: AIRSENSE 11 EXTERNAL PHOTOGRAPHS - US VARIANT Project/Product PACIFIC AIRSENSE 11 EXTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project Company Confidential Date last saved: 1-Nov-22Objective id: 72943_72944_A11_P3.10_M1_US_External PhotographsPage 2 of 5 1. Purpose This document contains the external photographs for the Pacific Project, and is applicable to the following device models: Model Name / Product Code Marketing Name 39517 AirSense 11 AutoSet USA 39518 Airsense 11 CPAP USA 39519 AirSense 11 Elite USA 39520 AirSense 11 AutoSet CAN 39521 AirSense 11 CPAP CAN 39522 AirSense 11 Elite CAN 2. External Photographs View Photographs Front View AIRSENSE 11 EXTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project Company Confidential Date last saved: 1-Nov-22Objective id: 72943_72944_A11_P3.10_M1_US_External PhotographsPage 3 of 5 View Photographs Rear View Left Side View AIRSENSE 11 EXTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project Company Confidential Date last saved: 1-Nov-22Objective id: 72943_72944_A11_P3.10_M1_US_External PhotographsPage 4 of 5 View Photographs Right Side View Top View AIRSENSE 11 EXTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project Company Confidential Date last saved: 1-Nov-22Objective id: 72943_72944_A11_P3.10_M1_US_External PhotographsPage 5 of 5 View Photographs Bottom View

OF 4 6.0 eLB1392-074 Melanie Theaker 8 September 2022 PAGE REV SPEC NO. ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way. © 2022 ResMed. SPECIFICATION FCC & ISED Labelling Submission Air 11 OF 4 6.0 eLB1392-074 Melanie Theaker 8 September 2022 PAGE REV SPEC NO. ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way. © 2022 ResMed. SPECIFICATION R390-7396 Product Specific Labels for FCC Base code: 39517 AirSense 11 AutoSet USA PRODUCT NAME PLAQUES Foiled product variant badges “permanently” attached to front of product SERIAL NUMBER LABELS Thermally printed labels attached to rear of product NOTE: - The device ID is the base code, which can be packaged in different boxes of accessories - CO means it is packed with a humidifier. - TRI means it is packed with a humidifier and heated tube. R390-7397 Base Code: 39518 AirSense 11 CPAP USA R390-7398 Base Code: 39519 AirSense 11 Elite USA 2 FCC & ISED Labelling Submission Air 11 OF 4 6.0 eLB1392-074 Melanie Theaker 8 September 2022 PAGE REV SPEC NO. ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way. © 2022 ResMed. SPECIFICATION R390-7397 Base code: 39521 AirSense 11 CPAP CAN R390-7396 Product Specific Labels for ISED Base code: 39520 AirSense 11 AutoSet CAN PRODUCT NAME PLAQUES Foiled product variant badges “permanently” attached to front of product SERIAL NUMBER LABELS Thermally printed labels attached to rear of product R390-7398 39522 AirSense 11 Elite CAN 3 NOTE: - The device ID is the base code, which can be packaged in different boxes of accessories - CO means it is packed with a humidifier. - TRI means it is packed with a humidifier and heated tube. FCC & ISED Labelling Submission Air 11 OF 4 6.0 eLB1392-074 Melanie Theaker 8 September 2022 PAGE REV SPEC NO. ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way. © 2022 ResMed. SPECIFICATION 4 BOTTOM VIEW OF DEVICE REAR VIEW OF DEVICE R390-429 R390-429 Additional Label for AMER devices fits into cavity FCC & ISED Labelling Submission Air 11

AIRSENSE 11 INTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties without prior consent from ResMed and not to be used in any unauthorised way. © ResMed Ltd 2022 Date last saved: 29-Dec-22Objective id: 72943_72944_A11_P3.10_M1_US_Internal Photographs_v2 Page 1 of 3 Title: AIRSENSE 11 INTERNAL PHOTOGRAPHS - US VARIANT Project/Product PACIFIC AIRSENSE 11 INTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project Company Confidential Date last saved: 29-Dec-22Objective id: 72943_72944_A11_P3.10_M1_US_Internal Photographs_v2 Page 2 of 3 1.Purpose This document contains the internal photographs of the PCBA for the Pacific Project, and is applicable to the following device models: Model Name / Product Code Marketing Name 39517 AirSense 11 AutoSet USA 39518 Airsense 11 CPAP USA 39519 AirSense 11 Elite USA 39520 AirSense 11 AutoSet CAN 39521 AirSense 11 CPAP CAN 39522 AirSense 11 Elite CAN 2.Internal Photographs View Photograph PCBA Top View Cellular Antenna Bluetooth Antenna AIRSENSE 11 INTERNAL PHOTOGRAPHS - US VARIANT for PACIFIC project Company Confidential Date last saved: 29-Dec-22Objective id: 72943_72944_A11_P3.10_M1_US_Internal Photographs_v2 Page 3 of 3 View Photograph PCBA Bottom View Cellular Module Cellular Module (Shield Removed)

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/…

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