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General| Device Type | CPAP Machine |
|---|---|
| Model | AirSense 10 |
| Operating Mode | CPAP, AutoSet, AutoSet for Her |
| Pressure Range | 4-20 cm H2O |
| Ramp Feature | Yes |
| Sound Level | 26 dBA |
| Data Storage | SD card |
| Compliance Tracking | Yes |
| Auto On/Off | Yes |
| Altitude Adjustment | Automatic |
| Ramp Time | 0 to 45 minutes |
| Humidifier | Integrated HumidAir Humidifier |
| Heated Tubing | Optional |
| Weight | 2.75 lbs |
| Power Consumption | 53 Watts (max) |
| Power Supply | 100-240V AC |
| Operating Conditions Temperature | 41°F to 95°F (5°C to 35°C) |
| Operating Conditions Humidity | 10 to 95% non-condensing |
| Display | LCD |
| Connectivity | Bluetooth |
Details the intended use of the AirSense 10 devices for treating obstructive sleep apnea (OSA).
Describes the AutoSet, AutoSet for Her, Elite, and CPAP models of the AirSense 10 device.
Lists conditions where therapy is contraindicated and potential side effects.
Lists conditions where therapy is contraindicated and potential side effects.
Details the functions of the Start/Stop button, Dial, and Home button.
Illustrates and explains various icons displayed on the device screen.
Explains how the AutoSet algorithm adjusts pressure based on breathing parameters.
Describes the normal breathing pattern and its corresponding flow-time curve.
Explains the ramp feature for comfort and Expiratory Pressure Relief (EPR).
Details Auto, Manual, Tube Temperature, and Humidity Level adjustments.
Guides on connecting supplemental oxygen and using antibacterial filters.
Explains the importance and procedure for setting the device's date and time.
Details how to configure patient therapy and device settings within the menu.
Explains setting Mode, Min Pressure, and Max Pressure for therapy.
Explains Ramp Time, Start Pressure, EPR, Climate Control, Tube Temp, Humidity Level.
Guides on selecting air tubing, antibacterial filters, and oximeter settings.
Details Language, Date, Time, Units, Restore Defaults, Erase Data, and About.
Provides step-by-step instructions for initiating and concluding a therapy session.
Explains how to access and interpret the Sleep Report on the device.
Explains Usage Hours, Events (AHI), Days Used, and Avg. Usage parameters.
Details Pressure, Leak, AHI, Total AI, and Central AI parameters.
Guides on taking apart and cleaning the water tub and air tubing.
Details how to check the water tub, air tubing, and air filter for damage.
Details surface disinfection and steps for air tubing disconnection, decontamination, thermal disinfection.
Guides on disassembling and decontaminating the water tub and air outlet.
Details high-level thermal disinfection for water tub and air outlet.
Instructions for reassembling the air outlet and inserting the water tub seal.
Explains device's cellular communication and SD card for data transfer.
Explains the types of patient compliance data stored on the device and SD card.
Explains the two access levels, Essentials and Essentials Plus, for patient menu.
Details the device's ability to transmit therapy data via cellular communication.
Provides guidance for traveling with the AirSense 10 device on an airplane.
Offers solutions for common problems and possible causes.
Details power supply unit specs and environmental operating/storage conditions.
Addresses EMC requirements and the device's IEC 60601-1 classification.
Lists dimensions, weight, construction, and material of device and water tub.
States water capacity and material for standard and cleanable water tubs.
Details humidifier performance tested at ambient temperature.
Lists types of air tubing with material, length, and inner diameter.
Specifies heated tubing cut-out and provides important notes.
Shows pressure sensor, flow, and leak measurement ranges and resolutions.
Provides accuracy specifications for pressure and flow measurements.
Shows dynamic pressure variation data for different tubing and humidification settings.
Tabulates maximum flow rates at various pressure settings for different tubing types.
Provides information on proper disposal of the device and environmental considerations.
Recommends inspection and servicing by authorized centers for device maintenance.
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