User guide English
Setting Up Device Power Cord Tub Power Supply Tubing Mask
ENGLISH Contents Welcome ............................................................................................................................................... 1 Indications for use .................................................................................................................. 1 Contraindications .................................................................................................................... 1 Adverse effects .................................................
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. CAUTION In the US, Federal law restricts this device to sale by or on the order of a physician.
ResMed Product Software License Terms Ownership: This ResMed product includes ResMed proprietary software owned or licensed to ResMed (the "Product Software"). The Product Software is licensed to the owner and user of the ResMed product as such license is described below.
At a glance WARNING Use only recommended ResMed masks and accessories or other vented masks as recommended by the prescribing doctor with this device. Using these components allows normal breathing and prevents potential asphyxiation. The AirSense 11 system includes the following: • Device • HumidAir™ 11 Standard tub • ClimateLineAir™ 11 heated tubing or SlimLine™ tubing • 65W AC adaptor • Travel bag • SD card (not available in all devices).
About your device Description Purpose 1 Start Therapy/ Standby button Press to start/stop therapy. The LED indicator is green during standby mode, and white during therapy, Test Drive, and Mask Fit functions. 2 Display touch screen Navigates between functions and displays information on the operating status of the device. 3 HumidAir 11 tub Water tub that provides heated humidification. 4 Device label Contains information relevant to the device.
Setting up your device WARNING Do not use any additives in the humidifier tub (eg, scented oils or perfumes). These may reduce humidification output and/or cause deterioration of the tub materials. CAUTION Use only ResMed parts (eg air inlet filter, power supplies), masks and accessories with the machine. Non ResMed parts may reduce the effectiveness of the treatment, may result in excess carbon dioxide rebreathing and/or damage the machine. For compatibility information, refer to ResMed.
To set up the device: 1. Place the device on a stable level surface. 2. Connect the power cord into the power inlet at the rear of the device. Connect one end of the power cord into the AC adaptor and the other end into the power outlet. 3. Connect the air tubing firmly to the outlet connector at the rear of the device. 4. Open the humidifier tub and fill it with distilled water under room temperature up to the maximum water level mark.
Navigating the touch screen The AirSense 11 device operates via a display touch screen, which allows you to access, view and change therapy and device settings. You can also track your sleep health progress. The status bar at the top of the screen may display icons at different times and may include: Icon Description Purpose Home Screen Return to the Home screen at any time. Humidifier fault Detects fault in the humidifier. Therapy will run without heating.
Using the touch screen: There are two actions to navigate through the touch screen: Flick: Flick up or down the screen to view menu options. A flick action will move the menu one full screen. Tap: Select a parameter setting to update. For other parameters (eg Pressure Relief, Airplane mode), tap the parameter to turn it on or tap to turn it off .
Connecting your AirSense 11 device and smart device RMDpulse is a smartphone app that guides you through the setup process. This includes device setup videos, mask fitting videos, trying therapy using the Test Drive feature, and tracking your sleep health progress. The app is not required to operate the AirSense 11 device. Before pairing the AirSense 11 device to a smartphone, ensure the app's latest version is installed on the smartphone. If not, download the app from the App Store® or on Google® Play.
About the heated tubing The ClimateLineAir 11 is a heated breathing tube that delivers air to a compatible mask. When used with the device humidifier tub, ClimateLineAir 11 heated air tubing allows you to use the Climate Control feature. Note: Not all types of air tubing are available in all regions. Climate Control Climate Control is designed to make therapy more comfortable by enabling constant temperature and maintaining humidity.
Tube Temperature Climate Control Humidity Level 1. Tap Tube Temp. 1. Tap Climate Control. 1. Tap Humidity Level. 2. Tap the preferred setting. 2. Tap Manual. 2. Tap the preferred setting. 3. Tap OK to save the change. 3. Tap OK to save the change. 3. Tap OK to save the change. Note: The temperature and humidity settings are not measured values. Therapy data The AirSense 11 device records your therapy data for viewing and adjusting by your care provider if required.
To remove the SD card cover and insert SD card: 1. 2. 3. 4. Push the SD card cover. Remove the SD card cover and keep the SD card cover in a safe place. Insert the SD card. Push in the SD card until it clicks in place. To remove the SD card: 1. Push in the SD card to release it. 2. Place the SD card in the protective folder and follow your care provider’s instructions. For more information on the SD card, refer to the SD card protective folder provided with your device.
CAUTION • • Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the device, the humidifier tub or air tubing. These solutions may cause damage or affect the humidifier performance and reduce the life of the products. Exposure to smoke, including cigarette, cigar or pipe smoke, as well as ozone or other gases, may damage the device. Damage caused by any of the foregoing, will not be covered by ResMed's limited warranty.
Daily: 1. Empty the humidifier tub and wipe it thoroughly with a clean disposable cloth. Allow it to dry out of direct sunlight. 2. Refill the humidifier tub with distilled water. Weekly: 1. Wash the humidifier tub, air tubing, and outlet connector in warm water using a household dishwashing liquid. They should not be washed in temperatures higher than 149°F (65°C). 2. Rinse each component thoroughly in water. 3. Allow to dry out of direct sunlight or heat. 4.
Replacing the air filter 1. Open the air filter cover and remove the old air filter. The air filter is not washable or reusable. 2. Place a new air filter onto the air filter cover and then close the cover. Make sure the air filter and air filter cover is fitted at all times to prevent water and dust from entering the device. Reassembling When the humidifier tub and air tubing are dry, you can reassemble the parts. To reassemble the AirSense 11 system: 1.
To turn on Airplane mode: 1. From the Home screen, tap MORE. 2. Flick down the menu to locate Airplane Mode. 3. Tap Airplane mode to switch it on. Troubleshooting If you have any problems, have a look at the following troubleshooting topics. If you are not able to fix the problem, contact your care provider or ResMed. Do not try to open the device. General Issues Problem/possible cause Solution Air is leaking from around my mask Mask may be fitted incorrectly. Make sure your mask is fitted correctly.
Problem/possible cause Solution SmartStop is enabled, but does not automatically stop when I remove the mask. Incompatible mask being used Only use equipment recommended by ResMed. Contact ResMed or see ResMed.com for more information. If you are using a nasal pillows mask with set pressure less than 7 cm H2O (7 hPa). SmartStop will not work and should be disabled. If you are using a conduit mask, SmartStop will not work and should be disabled.
Technical specifications 65W AC adaptor AC input range: 100-240v, 50-60Hz, 2.0A 115V, 400Hz, 1.5A (for aircraft use) 24 VDC ± 1 VDC, 2.71A 9.0W 71.9W Class II DC output: Typical power consumption: Peak power consumption: Class of Equipment: Environmental conditions Operating temperature: +41°F to +95°F (+5°C to +35°C) Note: The airflow for breathing produced by this therapy device can be higher than the room temperature. Under extreme ambient temperature conditions (104°F/40°C) the device remains safe.
Sound Pressure level measured according to ISO 80601-2-70:2015 and ISO 80601-2-79:2018: Device with SlimLine and humidifier tub (tub half filled) : 27 dBA with uncertainty of 2 dBA Power level measured according to ISO 80601-2-70:2015 and ISO 80601-2-79:2018: Device with SlimLine and humidifier tub (tub half filled): 35 dBA with uncertainty of 2 dBA Physical - device and humidifier tub Dimensions (H x W x D): Air outlet: Wight (device and standard humidifier tub): Weight (device and cleanable humidifier tub
Pneumatic flow path 1. Flow sensor 2. Blower 3. Pressure sensor 4. Mask 5. Air tubing 6. Humidifier 7. Device 8. Inlet filter Displayed values - Pressure at Mask Displayed mask pressure Range 4-20 cm H2O Accuracy ±0.5 cm H2O ±4% of measured reading Display resolution 0.1 cm H2O Pressure accuracy Maximum static pressure variation at 10 cm H2O (10 hPa) according to ISO 80601-2-70:2015 Device with humidifier tub and air tubing: ±0.
Wireless module Technology used 2G 3G 4G LTE Cat 1 Frequencies (MHz) 900/ 1800 * 850/ 900/ 1700/ 1900/ 2100* 700/ 850/ 1700/ 1900* Max RF power output (dBm) 33.0 23.5 23.0 *(bands may not be available in all regions) FCC ID: 2ACHL-AIR114G IC: 9103A-AIR114G 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.
Climate Control Auto2 - ClimateLineAir 11 Mask Pressure cm H2O (hPa) 4 10 20 1 2 Nominal % RH delivered to mask, tested in 72ºF (22ºC) ambient 85% 85% 85% Nominal system output mg/L AH1, BTPS2 ≥ 12 ≥ 12 ≥ 12 AH - Absolute Humidity in mg/L BTPS - Body Temperature Pressure Saturated Air tubing ClimateLineAir 11 60 to 86ºF (16 to 30ºC) 106ºF (41ºC) 25 cm H2O - SlimLine/ Standard 106ºF (41ºC) 25 cm H2O 106ºF (41ºC) Flexible plastic Inner diameter Flexible plastic and electrical components 0.
Guidance and manufacturer’s declaration electromagnetic emissions and immunity WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 3.9" (10 cm) to any part of the device. Otherwise, degradation of the performance of this equipment could result. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document.
Immunity test IEC60601-1-2 test Compliance level Electromagnetic environment — guidance Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Conducted RF IEC 61000-4-6 6 Vrms 150 kHz to 80 MHz 6 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 9 V/m to 28 V/m at 27 V/m to 85 V/m at frequencies up to 5.785 frequencies up to 5.
California Perchlorate Information: The coin-cell battery within this device may contain Perchlorate Material - special handling may apply. See: www.dtsc.ca.gov/hazardouswaste/perchlorate Servicing The AirSense device is intended to provide safe and reliable operation when operated in accordance with the instructions provided by ResMed. ResMed recommends that the AirSense device be inspected and serviced by an authorized ResMed Service Centre if there is any sign of wear or concern with device function.
Visit ResMed.com for the latest information on ResMed's Limited Warranty. Further information If you require additional information on how to setup, use or maintain the Air11™ system (including ClimateLineAir 11 heated tubing), or to report unexpected operation or events, please contact the ResMed Service Centre or your care provider.
ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia See ResMed.com for other ResMed locations worldwide. Air11, AirSense, AutoSet, ClimateLine, ClimateLineAir, HumidAir, SlimLine and SmartStart are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. SD Logo is a trademark of SD-3C, LLC. Google Play and the Google Play logo are trademarks o f Google LLC.
ENGLISH FCC information (4G) This document provides additional information regarding compliance of the AirSense 11device with FCC Rules and Industry Canada Rules. FCC ID: 2ACHL-AIR114G 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.
AirSense 11 aux règlements de la FCC et aux règles d’Industrie Canada. ID FCC : 2ACHL-AIR114G Cet appareil est conforme à la Section 15 des réglementations de la FCC. Son fonctionnement est soumis aux deux conditions suivantes : • • Cet appareil ne doit pas causer de brouillage préjudiciable, et Cet appareil doit accepter tout brouillage subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.
