Table of Contents
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Table of Contents
Related Manuals for ResMed Defy Mini
Summary of Contents for ResMed Defy Mini
- Page 1 Clinical guide English...
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Page 2: Table Of Contents
Contents Welcome ............................1 AirCurve 10 CS PaceWave indications for use ............... 1 Contraindications ........................1 Adverse effects ........................1 At a glance ........................... 2 About the control panel ......................3 Therapy information ........................4 ... - Page 3 Decontaminating ......................22 Disinfecting ........................22 Inspecting ........................23 Reassembling ......................... 23 Packaging and storage ....................24 Data management and therapy compliance ................25 Remote monitoring ....................... 25 SD card ..........................25 ...
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Page 4: Welcome
Welcome ™ ™ The AirCurve 10 CS PaceWave is a positive airway pressure device that belongs to the adaptive servo-ventilator category. WARNING Read this entire guide before using the device. Use the device according to the intended use provided in this guide. ... -
Page 5: At A Glance
At a glance The AirCurve 10 includes the following: Device ™ HumidAir humidifier Air tubing Power supply unit Travel bag SD card (already inserted). A range of accessories are available for use with the device including: ... -
Page 6: About The Control Panel
About the control panel Press to start/stop therapy. Start/Stop button Press and hold for three seconds to enter power save mode. Turn to navigate the menu and press to select an option. Dial Turn to adjust a selected option and press to save your change. -
Page 7: Therapy Information
Therapy information ASV, ASVAuto and CPAP mode are available on the AirCurve 10 CS PaceWave device. ASV therapy ResMed's ASV therapy targets the patient’s own recent Minute Ventilation (MV). It treats central sleep apnoea and/or mixed apnoea and periodic breathing by automatically adjusting the pressure support (PS) in a defined pressure range to maintain Minute Ventilation at the target. -
Page 8: Backup Rate
Backup rate The AirCurve 10 CS PaceWave device uses breath phase mapping to provide a timed backup rate that is synchronised with the patient’s own breathing. When the patient deviates from the ventilatory target, the CS PaceWave device aims to stabilise the patient by adjusting Pressure Support. -
Page 9: Climate Control
Climate Control Climate Control is an intelligent system that controls the humidifier and the ClimateLineAir heated air tubing to deliver constant, comfortable temperature and humidity levels during therapy. Designed to prevent dryness of the nose and mouth, it maintains the set temperature and relative humidity during sleep. -
Page 10: Setup
Setup CAUTION Do not overfill the humidifier as water may enter the device and air tubing. 1. Place the device on a stable level surface. 2. Plug the power connector into the rear of the device. Connect one end of the power cord into the power supply unit and the other end into the power outlet. -
Page 11: Supplemental Oxygen
Supplemental oxygen The AirCurve 10 device is designed to be compatible with up to 15 L/min of supplemental oxygen in CPAP and ASV modes and up to 4 L/min in ASVAuto mode. At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary depending on the pressure settings, patient breathing pattern, mask selection and the leak rate. -
Page 12: Accessing And Exiting The Clinical Menu
Accessing and exiting the Clinical Menu You can access, view and set parameters relating to a patient's therapy and device configuration in the Clinical Menu. To access the Clinical Menu: Press and hold the dial and the Home button for three seconds. The Home screen is displayed with an unlock icon in the top right corner of the screen. -
Page 13: Setting The Date And Time
The settings can be changed in different ways depending on the type of screen: Turn the dial to edit live in Turn the dial to change Select from a list of options. the menu. the setting. Setting the date and time Before you set up a new patient and start therapy for the first time, make sure you set the correct local date and time on the device. -
Page 14: Comfort
Min EPAP Sets the minimum EPAP (minimum 4–15 cm H O (4–15 hPa) expiratory pressure) delivered by the device. Max EPAP Sets the maximum EPAP delivered 4–15 cm H O (4–15 hPa) by the device. Dependent on Min EPAP. -
Page 15: Options
Ext. Select Yes if you connect an external humidifier. No / Yes humidifier View Displayed at all times when an oximeter is connected. 0-300 hrs oximeter 0-100% SpO Options Parameter Description Range Essentials Set the level of access available to the patient. On / Plus Leak Alert Enable / disable the Leak Alert feature. - Page 16 Press. Units Set the unit of pressure in which pressure is displayed. cm H O / hPa Temp. Units Set the temperature units. °F / °C Restore Reset to default settings (except for language, date and time). Yes / No Defaults Erase Data Erase all data stored on the device and the SD card.
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Page 17: 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 pressure bar shows the inspiratory and expiratory pressures in green. -
Page 18: 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 Apnoeas and hypopnoeas measured per hour for one day. An apnoea is when the respiratory flow decreases by more than 75% for at least 10 sec. A hypopnoea is when the respiratory flow decreases to 50% for at least 10 sec. -
Page 19: Cleaning And Maintenance
Cleaning and Maintenance It is important that the AirCurve 10 device is cleaned regularly to ensure optimal therapy. The following sections will help with disassembling, cleaning, checking and reassembling the device. Disassembling 1. Hold the humidifier at the top and bottom, press it gently and pull it away from the device. 2. -
Page 20: Checking
Checking You should regularly check the humidifier, air tubing and the air filter for any damage. 1. Check the humidifier: Replace it if it is leaking or has become cracked, cloudy or pitted. Replace it if the seal is cracked or torn. ... -
Page 21: Reprocessing
Reprocessing When the device is used for multiple patients, for example, in a sleep lab, clinic, hospital or at a health care provider, the cleanable humidifier, air outlet and air tubing should be reprocessed between each patient use. 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. -
Page 22: Reprocessing The Air Tubing
Reprocessing the air tubing Disconnecting 1. Hold the cuff of the air tubing and gently pull it away from the device. 2. Hold both the cuff of the air tubing and the swivel of the mask, then gently pull apart. Decontaminating Before the disinfection process, each component must be cleaned and rinsed so no visible contamination is present. -
Page 23: Inspecting
High level chemical Part Validated number of cycles ® CIDEX OPA Ortho-phthalaldehyde 0.55% for 12 minutes SlimLine ClimateLineAir Standard 1. Soak the air tubing in a commercially available solution of a chemical sterilant. Take care that no air bubbles are trapped inside the air tubing. 2. -
Page 24: 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 25: Decontaminating
Decontaminating Before the disinfection process, each component must be cleaned and rinsed so no visible contamination is present. 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. -
Page 26: 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 27: 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 28: Data Management And Therapy Compliance
Data management and therapy compliance For therapy management, the AirCurve 10 device stores patient therapy data on the device and has the ability to transfer it remotely to the care provider. Data can then be accessed via ResMed's ™ AirView therapy management solution. -
Page 29: Data Storage
Data storage The AirCurve 10 device stores summary data such as AHI, Total Hours Used and Leak. Night profile data such as snore and pulse rate are stored on the SD card and can be viewed with AirView and ResScan. -
Page 30: Managing Patient Care
Managing patient care The following section has been provided to assist you with managing your patients' care. Patient menu In the patient menu there are two types of access levels, Essentials and Essentials Plus. Essentials is designed to make the device interaction and menu navigation easier for patients. It is a simple choice for patients who do not want to worry about settings or menu navigation. -
Page 31: 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 32 Problem/possible cause Solution Humidifier may be damaged or cracked. Replace the humidifier. The patient's therapy data has not been transmitted Wireless coverage may be poor. Advise the patient to place the device where there is coverage (ie, on their bedside table, not in a drawer or on the floor).
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Page 33: Device Messages
Device messages Device message/possible cause Solution High leak detected, check your water tub, tub seal or side cover Humidifier may not be inserted properly. Make sure the humidifier is correctly inserted. Humidifier seal may not be inserted properly. Open the humidifier and make sure that the seal is correctly inserted. -
Page 34: General Warnings And Cautions
General warnings and cautions WARNING Make sure that you arrange the air tubing so that it will not twist around the head or neck. Make sure the power cord and plug are in good condition and the equipment is not damaged. -
Page 35: Technical Specifications
Do not overfill the humidifier as water may enter the device and air tubing. Leave the humidifier to cool for ten minutes before handling to allow the water to cool and to make sure that the humidifier is not too hot to touch. ... - Page 36 Physical - device and humidifier Dimensions (H x W x D): 116 mm x 255 mm x 150 mm Air outlet (complies with ISO 5356-1:2004): 22 mm Weight (device and cleanable humidifier): 1248 g Housing construction: Flame retardant engineering thermoplastic Water capacity: To maximum fill line 380 mL Cleanable humidifier - material:...
- Page 37 Humidifier performance The following settings have been tested at 22°C ambient temperature: Mask Pressure RH output % Nominal system output AH , BTPS cm H O (hPa) Setting 4 Setting 8 Setting 4 Setting 8 >10 >10 >10 >10 >10 AH - Absolute Humidity in mg/L BTPS - Body Temperature Pressure Saturated...
- Page 38 Pressure accuracy Maximum static pressure variation at 10 cm H O (10 hPa) according to EN ISO 17510-1:2009 Standard air tubing SlimLine air tubing Without humidification ± 0.5 cm H O (± 0.5 hPa) ± 0.5 cm H O (± 0.5 hPa) With humidification ±...
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Page 39: Symbols
Symbols The following symbols may appear on the product or packaging. Read instructions before use. Indicates a warning or caution. Follow instructions before use. Manufacturer. European Authorised Representative. Batch code. Catalogueue number. Serial number. Device number. On / Off. Device weight. -
Page 40: Limited Warranty
Limited warranty ResMed Ltd (hereafter 'ResMed') warrants that your ResMed product shall be free from defects in material and workmanship from the date of purchase for the period specified below. Product Warranty period Mask systems (including mask frame, cushion, headgear and tubing)—excluding 90 days single-use devices ... - Page 41 ResMed Ltd DISTRIBUTED BY 1 Elizabeth Macarthur Drive ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA Bella Vista NSW 2153 Australia ResMed (UK) Ltd 96 Jubilee Ave Milton Park Abingdon Oxfordshire OX14 4RW UK See www.resmed.com for other ResMed locations worldwide. For patent and other intellectual property information, see www.resmed.com/ip.