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Table of Contents
Related Manuals for ResMed AirSense 10 AutoSet for Her Plus
Summary of Contents for ResMed AirSense 10 AutoSet for Her Plus
- Page 1 Clinical guide English...
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Page 2: Table Of Contents
Contents Welcome ........................... 1 Indications for use ........................ 1 AirSense 10 AutoSet Plus ....................1 AirSense 10 AutoSet for Her Plus .................. 1 AirSense 10 Elite Plus ....................1 Contraindications........................1 Adverse effects ........................2 At a glance ..........................2 About the control panel ...................... - Page 3 Cleaning ..........................21 Checking ........................... 22 Reassembling ........................22 Reprocessing .......................... 22 Surface disinfection ......................23 Reprocessing the air tubing and Air10 tubing elbow ............23 Disconnecting ......................23 Decontaminating ......................24 Disinfecting ......................... 24 Inspecting ........................25 Reconnecting the air tubing ..................25 Packaging and storage....................
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Page 4: Welcome
AirSense 10 AutoSet for Her Plus The AirSense 10 AutoSet for Her Plus self-adjusting device is indicated for the treatment of obstructive sleep apnea (OSA) in female patients with mild to moderate OSA weighing more than 30 kg. It is intended for home and hospital use. -
Page 5: Adverse Effects
DC/DC converter (12V/24V) • SD card reader • Air10 oximeter adapter Air10 USB adapter • • Power Station II • Air10 tubing elbow. Note: Make sure all parts and accessories used with the device are compatible. For compatibility information, refer to www.resmed.com. -
Page 6: About The Control Panel
Air outlet HumidAir humidifier Air filter cover Screen Power inlet Adapter cover Serial number and device number SD card cover About the control panel Press to start/stop therapy. Start/Stop button Press and hold for three seconds to enter power save mode. -
Page 7: Therapy Information
Therapy information The following modes are available on the AirSense 10 Plus device: Device Modes available AutoSet AutoSet for Her CPAP AirSense 10 AutoSet Plus AirSense 10 AutoSet for Her Plus AirSense 10 Elite Plus ... -
Page 8: Flow Limitation
Flow limitation As the upper airway begins to collapse, the shape of the inspiratory flow-time curve changes. The AirSense 10 Plus recognizes and treats traditional as well as less common flow-limited breath wave forms. 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. - Page 9 Obstructive apnea An obstructive apnea is when the upper airway becomes severely limited or completely obstructed. AutoSet generally prevents obstructive apneas from occurring by responding to flow limitation and snoring. If an obstructive apnea occurs, the device will respond by increasing pressure. Central apnea During a central apnea, the airway will remain open, but there is no flow.
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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: Reduced rate of pressure increments designed to help prevent arousals. -
Page 11: Reporting
(data availability depends on device mode and parameter measured). Central sleep apnea detection Available in all modes on the AirSense 10 AutoSet Plus, AirSense 10 AutoSet for Her Plus and the AirSense 10 Elite Plus. The device detects both obstructive and central sleep apneas (CSA). CSA detection uses the Forced Oscillation Technique (FOT) to determine the state of the patient’s airway during an apnea. -
Page 12: Respiratory Effort Related Arousals Reporting
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: Comfort Features
Comfort features Ramp Designed to make the beginning of treatment more comfortable, ramp is available in all modes. In AutoSet mode, ramp time defines the period during which the pressure gradually increases from a lower more comfortable start pressure to the minimum treatment pressure before the auto-adjusting algorithm commences. -
Page 14: 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 15: Humidity Level
Humidity Level The humidifier moistens the air and is designed to make therapy more comfortable. If the patient is getting a dry nose or mouth, turn up the humidity. If the patient is getting moisture in their mask, turn down the humidity. 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. -
Page 16: Setup
5. Close the humidifier and insert it into the side of the device. 6. Connect the free end of the air tubing firmly onto the assembled mask. See the mask user guide for detailed information. Recommended masks are available on www.resmed.com. English... -
Page 17: Supplemental Oxygen
Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and delivered pressure, particularly at high flows. ResMed recommends using an antibacterial filter with a low impedance [eg, 2 cm H O (2 hPa) at 60 L/min], such as PALL (BB50T), Filter without Luer Port (4222/702) or the Filter with Side Port 24966 (4222/701). -
Page 18: Adjusting The Clinical Settings
Adjusting the clinical settings 1. Access the Clinical Menu, highlight Settings and press the dial. The Settings menu is displayed. 2. Turn the dial to highlight the setting you want to adjust and then press the dial. 3. Turn the dial to adjust the setting and press the dial to save the change. The settings can be changed in different ways depending on the type of screen: Turn the dial to edit live in the Turn the dial to change the... -
Page 19: Settings Menu
O (0.2 hPa) increments Mask Select the type of mask used by Full Face / Nasal / Pillows the patient. Refer to Mask Device Compatibility List on www.resmed.com. Comfort Parameter Description Mode Range AutoSet AutoSet CPAP for Her... -
Page 20: Accessories
Parameter Description Mode Range AutoSet AutoSet CPAP for Her Tube Temp. Set the minimum temperature of Off /16–30°C, 1° increments air delivered by heated air tubing such as ClimateLineAir. Humidity Set the humidity level. Off / 1–8 ... -
Page 21: Configuration
Configuration Parameter Description Selection Language Set the display language. English /简体中文 / 繁體中文 (Not all languages available in all regions.) Date Set the current date. DD Mmm YYYY If you set a new date that occurs in the past then an error message is displayed. -
Page 22: Starting Therapy
Starting therapy 1. Direct the patient to fit their mask. 2. Direct the patient to press Start/Stop, or if the SmartStart feature is enabled, direct them to breathe into their mask. Therapy will begin and the Sleep Report screen is displayed. The current treatment pressure is shown in green. -
Page 23: Sleep Report Screen Parameters
Sleep Report screen parameters Parameter Description Usage hours Number of hours the device has been used during the last session. Events (AHI) per hour Apneas and hypopneas measured per hour for one day. An apnea is when the respiratory flow decreases by more than 75% for at least 10 sec. A hypopnea is when the respiratory flow decreases to 50% for at least 10 sec. -
Page 24: Cleaning And Maintenance
Cleaning and Maintenance It is important that the AirSense 10 Plus device is cleaned regularly to ensure optimal therapy. The following sections will help with disassembling, cleaning, checking and reassembling the device. WARNING Regularly clean the tubing assembly, humidifier and mask for optimal therapy and to prevent the growth of germs that can adversely affect the patient's health. -
Page 25: Checking
If the cleanable humidifier or the air tubing are being used for a single user in the home, refer to the cleaning instructions in this guide or in the User Guide. Described here are ResMed’s recommended and validated procedures for cleaning and disinfecting the cleanable humidifier, air outlet and air tubing. However, the steps for disinfection vary regionally and each healthcare facility should consult its own procedures before carrying out those within this guide. -
Page 26: Surface Disinfection
WARNING • ResMed cannot give any assurance that deviations from the procedures listed in this guide, and their effect on the performance of the product, will be acceptable. • When using detergents, disinfectants or sterilization agents, always follow the manufacturer's instructions. -
Page 27: Decontaminating
2. Run the detergent solution through the air tubing repeatedly until no contamination is visible. 3. Thoroughly rinse each component according to the detergent manufacturer's instructions. ResMed has tested the following detergents according to the manufacturer’s instructions: Detergent Water temperature... -
Page 28: Inspecting
High level chemical disinfection Part Validated number of cycles CIDEX ® OPA Ortho-phthalaldehyde ® Gigasept FF 5% for 15 minutes 0.55% for 12 minutes SlimLine – ClimateLineAir ClimateLineAir Oxy Standard – Air10 tubing elbow 1. Soak the air tubing/Air10 tubing elbow in a commercially available solution of a chemical sterilant. Take care that no air bubbles are trapped inside the air tubing. -
Page 29: Reprocessing The Humidifier And Air Outlet
Reprocessing the humidifier and air outlet Disassembling The following instructions provide guidance on how to correctly disassemble the cleanable humidifier and the air outlet. 1. Remove the humidifier from the device, open it and discard any remaining water. 2. Hold the humidifier base and then fully open the humidifier lid and pull it away so that it easily detaches from the base. -
Page 30: Decontaminating
1. Clean all components with a soft bristled brush for one minute while soaking in detergent solution (see table below). Pay particular attention to all crevices and cavities. 2. Thoroughly rinse each component according to the detergent manufacturer's instructions. ResMed has tested the following detergents according to the manufacturer’s instructions: Detergent Water temperature... -
Page 31: Inspecting
Inspecting Perform a visual inspection of all components. If any visible deterioration is apparent (cracking, crazing, tears, etc), the humidifier should be discarded and replaced. Slight discoloration of the silicone components may occur and is acceptable. Reassembling The following instructions provide guidance on how to correctly reassemble the air outlet and the humidifier. -
Page 32: Packaging And Storage
To reassemble the humidifier lid: 1. Insert one side of the lid into the pivot hole of the base. 2. Slide the other side down the ridge until it clicks into place. Packaging and storage Store in a dry, dust-free environment away from direct sunlight. Storage temperature: -20°C to 60°C. -
Page 33: Data Storage
• Make sure the patient has the appropriate power cord for the region of travel. For information on purchasing, contact your ResMed representative. When using an external battery, turn off the humidifier in order to maximize battery life. Do this •... -
Page 34: Traveling By Plane
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 35 Sleep report for the humidifier indicates Humidifier fault Contact your local ResMed dealer or ResMed office. SmartStart is enabled, but the device does not automatically start when the patient breathes into their mask Breath is not deep enough to trigger SmartStart.
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Page 36: Device Messages
All other error messages, for example, System fault, refer to user guide, Error 0XX An unrecoverable error has occurred on the device. Contact your local ResMed dealer or ResMed office. Do not open the device. English... -
Page 37: General Warnings And Cautions
CAUTION • Use only ResMed parts and accessories with the device. Non-ResMed parts may reduce the effectiveness of the treatment and/or damage the device. • Use only vented masks recommended by ResMed or by the prescribing doctor with this device. -
Page 38: Technical Specifications
IEC 60601-1-2:2014, for residential, commercial and light industry environments. It is recommended that mobile communication devices are kept at least 1 m away from the device. Information regarding the electromagnetic emissions and immunity of this ResMed device can be found on www.resmed.com/downloads/devices Classification: IEC 60601-1:2005+A1:2012 Class II (double insulation), Type BF, Ingress protection IP22. - Page 39 Declaration of Conformity (DoC to the R&TTE Directive) ResMed declares that the AirSense 10 device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. A copy of the declaration of conformity (DoC) can be found on www.ResMed.com/ProductSupport.
- Page 40 Pneumatic flow path 1. Flow sensor 2. Blower 3. Pressure sensor 4. Mask 5. Air tubing 6. Humidifier 7. Device 8. Inlet filter Design life Device, power supply unit: 5 years Cleanable humidifier: 2.5 years Air tubing: 6 months Humidifier performance Mask Pressure RH output % at 17°C RH output % at 22°C...
- Page 41 Displayed values Value Range Display resolution Pressure sensor at air outlet: Mask pressure 4–20 cm H 0 (4–20 hPa) 0.1 cm H O (0.1 hPa) Flow derived values: Leak 0–120 L/min 1 L/min Value Accuracy Pressure measurement Mask pressure ±[0.5 cm H 0 (0.5 hPa) + 4% of measured value] Flow and flow derived values Flow...
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Page 42: Symbols
ResMed. ResMed recommends that the AirSense 10 Plus device be inspected and serviced by an authorized ResMed Service Centre if there is any sign of wear or concern with device function. Otherwise, service and inspection of the products generally should not be required during their design life. -
Page 43: Limited Warranty
• Portable diagnostic/screening devices 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. - Page 44 See www.resmed.com for other ResMed locations worldwide. For patent and other intellectual property information, see www.resmed.com/ip. Air10, AirSense, AutoSet, ClimateLine, EPR, HumidAir, SlimLine and SmartStart are trademarks and/or registered trademarks of the ResMed family of companies. Actichlor is a trademark of Ecolab US Inc. Alconox is a trademark of Alconox Inc. Cavicide is a registered trademark of Metrex Research, LLC.
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