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Table of Contents
Related Manuals for ResMed AirSense 11
Summary of Contents for ResMed AirSense 11
- Page 1 Clinical guide English...
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Page 2: Table Of Contents
Setting up your device ........................12 Navigating the touch screen ......................14 Accessing the Clinical menu ....................15 Adjusting Clinical settings ......................17 Connecting your AirSense 11 device and smart device ............17 Settings Menu ..........................18 Therapy Settings ........................18 Comfort Settings ........................18 Options ............................. - Page 3 Disinfection ..........................30 Reassembling ........................... 30 Packing and storing ........................31 Data management and therapy compliance .................. 32 Remote monitoring ........................32 Data storage ............................ 33 Troubleshooting ..........................34 General Warnings ........................... 36 Technical specifications ......................... 37 Symbols ............................41 Limited warranty ..........................
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Page 4: Welcome
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... -
Page 5: Software Functionality And Device Data
ResMed via the cloud to enable ResMed to deliver various benefits to you and your care provider(s). Additionally, some of that data may be used by ResMed (1) to comply with its legal obligations; these legal obligations include collection and analysis of device data for... -
Page 6: At A Glance
SD card cover Notes: • The AirSense 11 device is compatible with ResMed masks. For a complete list, see the Mask/Device compatibility list on ResMed.com/downloads/devices. • It is the responsibility of the equipment provider or clinician to ensure that parts and accessories are compatible with this device prior to use by the patient. -
Page 7: About Your Device
About your device Description Purpose 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. Display touch screen Navigates between functions and displays information on the operating status of the device. -
Page 8: Therapy Information
Flow limitation As the upper airway begins to collapse, the shape of the inspiratory flow-time curve changes. The AirSense 11 recognizes and treats traditional as well as less common flow-limited breath wave forms. English... -
Page 9: Snore
Snore Snoring is sound generated by vibrations of the walls of the upper airway. It is often preceded by flow limitation or a partial obstruction of the airway. Apnea The enhanced AutoSet algorithm detects both obstructive and central apneas. If an apnea occurs, the device responds appropriately. -
Page 10: Autoset For Her Mode
AutoSet for Her mode AutoSet for Her mode is based on key aspects of ResMed’s AutoSet algorithm and delivers therapeutic responses tailored to the characteristics of female OSA patients. The AutoSet for Her is similar to ResMed’s AutoSet algorithm with the following modifications: •... -
Page 11: Cheyne-Stokes Respiration Detection
OSA period. The AirSense 11 device reports the time during therapy in which it detected breathing patterns indicative of CSR. It analyzes the patient's respiratory flow for apnea/hypopnea events, calculates the time between... -
Page 12: Respiratory Effort Related Arousals Reporting
Respiratory effort related arousals reporting Respiratory Effort Related Arousals (RERA) reporting is available on the AirSense 11 AutoSet and AirSense 11 Elite in all modes. RERAs are periods of increasing respiratory effort which are terminated by an arousal. Increasing respiratory effort will be seen as airflow limitation.These flow-based RERA events are logged and stored as summary and/or detailed data and can then be viewed in one of ResMed's patient management systems. -
Page 13: Autoset Response
Standard or Soft. If set to soft, patients will receive gentler pressure rises during therapy. Patients who use the AutoSet Response feature will still get the benefits of ResMed's AutoSet technology including improved sensitivity to flow-limitation and CSA Detection with Forced Oscillation Technique. - Page 14 • The Humidity Level can be set to: Off or between 1 and 8, where 1 is the lowest humidity setting and 8 is the highest humidity setting. For each humidifier setting, the Climate Control system delivers a constant amount of water vapor, or absolute humidity (AH), to the patient's upper airway.
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Page 15: Setting Up Your Device
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. - Page 16 Recommended masks for use with this device are listed on ResMed.com. Notes: • Do not insert any USB cable into the AirSense 11 device or attempt to plug the AC adaptor into a USB device. This may cause damage to the AirSense 11 device or USB device. •...
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Page 17: Navigating The Touch Screen
Navigating the touch screen The AirSense 11 device operates via a display touch screen. This allows you to access, view and change therapy and device settings and to track the sleep health progress of your patient. The status bar at the top of the screen may display icons at different times and may include:... -
Page 18: Accessing The Clinical Menu
Accessing the Clinical menu From the Welcome screen, tap CLINICIAN The Clinician handover screen will appear. Tap OK to continue or BACK to return to previous screen. The Home screen will appear. This is also the Patient Home screen. The menu options are: MY OPTIONS: for the patient to view and adjust therapy settings (eg, Adjust Ramp time) MY SLEEP VIEW: for the patient to track their sleep health (eg, check... - Page 19 Using the touch screen: There are two actions to navigate through the touch screen: Swipe: Swipe up or down the screen to view menu options.. 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 To update settings: Tap SETTINGS.
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Page 20: Adjusting Clinical Settings
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 ®... -
Page 21: Settings Menu
Settings Menu Therapy Settings Mode Parameter Description Range AutoSet AutoSet CPAP for Her Mode Sets the therapy mode available on the device. Pressure Range Sets the pressure range for Select Min Pres.: treatment. 4-20 cm H O (hPa), 0.2cm H O (hPa) increments. -
Page 22: Options
Options Parameter Description Range Patient View Set the level of access available to the patient. Simple/ Advanced SmartStart™* Enable/disable the SmartStart feature. If you enable the SmartStart feature, the On/ Off device will start automatically when the patient breathes into the mask. SmartStop* Enable/disable the SmartStop feature. -
Page 23: Setting The Time Zone
The patient data will need to be erased before changing the time zone. The AirSense 11 device is set up with GMT (Greenwich Mean Time) time zone settings. To change Time Zone: 1. -
Page 24: Starting/Stopping Therapy
Starting/stopping therapy WARNING The machine is not intended to be operated by persons (including children) with reduced physical, sensory or mental capabilities without adequate supervision by a person responsible for the patient’s safety. To start therapy: 1. Direct the patient to fit their mask. 2. -
Page 25: Viewing Sleep Data And Option Controls
Viewing sleep data and option controls The Sleep View screen shows sleep quality and mask seal status for the most recent therapy session. The parameters displayed will depend on the therapy mode. In the Patient view, there are two types of access levels: Simple and Advanced. The Simple view is designed to: •... -
Page 26: Supplemental Oxygen
Adding oxygen may affect the delivered pressure and the accuracy of the displayed and reported values • Oxygen concentration can be affected by a partial obstruction downstream of the AirSense 11 system. Fitting an oxygen port 1. Firmly connect the Oxygen Connector Port (A) directly to the air outlet (B) of the flow generator. -
Page 27: Cleaning And Caring For The Device
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. -
Page 28: Disassembling
Disassembling 1. Hold the humidifier tub at the top and bottom, press it gently and pull it away from the device. Note: take care when handling the humidifier tub as the humidifier tub may be hot. Allow 10 minutes for the heater plate and any excess water to cool. 2. -
Page 29: Checking
Checking WARNING • Discontinue use and contact your care provider or ResMed Service Center if any of the following occur: • device does not perform as usual • device is making unusual sounds • device is damaged • If using a bacterial/viral filter, regularly check it for signs of moisture or other contaminants, particularly during nebulization or humidification. -
Page 30: Preparing The Device For Use Between Patients
Do not connect to power while the device is wet. Make sure that all parts are dry before plugging it in. General summary ResMed has validated the following number of cycles for cleaning and disinfection using a manual cleaning method. Components... -
Page 31: Disassembling
Disassembling Before disassembly, turn off the device and ensure the AC adapter has been removed. Cleanable Humidifier tub 1. Hold the humidifier tub at the top and bottom, press it gently and pull it away from the device. Note: take care when handling the humidifier tub as the humidifier tub may be hot. Allow 10 minutes for the heater plate and any excess water to cool. -
Page 32: Device Enclosure
Device enclosure Cleaning Clean the device enclosure using an alcohol based cleaning and disinfection wipe. ResMed has validated CaviWipes1. 1. Wipe the exterior of the device using a wipe until visually clean following the manufacturer's instruction for cleaning. Use a minimum of two wipes. -
Page 33: Disinfection
Higher temperatures may damage the components. 3. Allow the components to dry out of direct sunlight. High level chemical disinfection 1. Make a solution of Ortho-phthalaldehyde 0.55% as directed by the disinfectant manufacturer. ResMed has validated: • CIDEX® OPA Ortho-phthalaldehyde 2. -
Page 34: Packing And Storing
Cleanable HumidAir 11 tub 1. Insert one side of the lid into the pivot hole of the base. Insert the other side of the lid into the pivot hole. 2. Push the lid down until it clicks in place. Air tubing 1. -
Page 35: Data Management And Therapy Compliance
ResMed's AirView ™ therapy management solution. The AirSense 11 device also stores data on the SD card. This data can be transferred via an SD Card Reader to ResMed's ResScan ™ therapy management system. The SD card should not be used for any other purpose as it may corrupt therapy data stored on the card. -
Page 36: Data Storage
Data storage The AirSense 11 device stores summary data such as AHI, Total Hours Used and Leak. Detailed data such as snore is stored on the SD card and can be viewed with AirView and ResScan. High resolution flow and pressure data are stored on the SD card. -
Page 37: Troubleshooting
Troubleshooting If there is a problem, try the following suggestions. If you are not able to fix the problem, contact your local ResMed dealer or ResMed office. Do not open the device. General troubleshooting Problem/possible cause Solution Air is leaking from around the mask Mask may be fitted incorrectly. - Page 38 SmartStop is enabled but does not automatically stop when the patient removes their mask Incompatible mask being used Only use equipment recommended by ResMed. Contact ResMed or see ResMed.com for more information If the patient is using a nasal pillows mask with set pressure less than 7cm H O (7 hPa), SmartStop will not work and should be disabled.
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Page 39: General Warnings
• Make sure that the humidifier tub is empty before transporting the device. For any serious incidents that occur in relation to this device, these should be reported to ResMed and the competent authority in your country. -
Page 40: Technical Specifications
4.0 cm H O (4 hPa). Flow (maximum) at set pressures The following are measured according to ISO 80601-2-70 201.12.1.103: Pressure AirSense 11, humidifier tub AirSense 11, humidifier tub AirSense 11, humidifier tub and Standard air tubing and SlimLine... - Page 41 3.94" (10 cm) separation distance. The AirSense 11 has been designed to meet EMC standards. However, should you suspect that the device performance (eg. pressure or flow) is affected by other equipment, move the device away from the possible cause of interference.
- Page 42 ±0.5 cm H O (±0.5 hPa) Note: Refer to the relevant measurement uncertainty from the Measurement system uncertainties table. Maximum dynamic pressure variation according to ISO 80601-2-70:2015 AirSense 11 with humidifier tub and air tubing Breath rate 10 BPM 15 BPM...
- Page 43 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 AirSense 11 device should be installed and operated with minimum distance of 0.59" (15 mm) between the equipment and the user's body.
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Page 44: Symbols
Note: The manufacturer reserves the right to change these specifications without notice. Air tubing resistance to flow and compliance information Refer to the Air tubing compliance guide in ResMed.com. Characteristics of compatible Bacterial/ Viral (B/V) filters Resistance over the flow range: Recommend a B/V filter with resistance of <... -
Page 45: Limited Warranty
ResMed shall 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... -
Page 46: Further Information
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. Visit ResMed.com for the latest information on ResMed's Limited Warranty. - Page 47 ResScan 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 of Google LLC. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S and other countries.