The ResMed AirSense 11 is a premium auto-adjusting pressure device (AutoSet, including AutoSet for Her) or a Continuous Positive Airway Pressure (CPAP) device (Elite, CPAP), designed for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for both home and hospital use.
Function Description:
The AirSense 11 operates via a display touch screen, allowing users to access, view, and change therapy and device settings, as well as track sleep health progress. It delivers positive airway pressure therapy, with or without heated humidification, to maintain an open airway during sleep. The device includes software functionalities that enable cloud connectivity, allowing remote access to therapy data and regular software updates via Bluetooth® wireless technology, WiFi, and/or cellular networks.
Important Technical Specifications:
- Operating pressure range: 4 to 20 cm H₂O (4 to 20 hPa).
- Maximum single fault steady-state pressure: The device will shut down if the steady-state pressure exceeds 40 cm H₂O (40 hPa) for more than 1 second.
- Pressure measurement tolerance: ± 0.5 cm H₂O (0.5 hPa) ±4% of measured reading.
- Flow measurement tolerance: ± 6 L/min or 10% of reading, whichever is greater, at 0 to 150 L/min positive flow.
- Device dimensions (H x W x D): 5.45" x 10.21" x 3.72" (138.5 mm x 259.4 mm x 94.5 mm).
- Weight (device and standard humidifier tub): 40 oz (1130 g).
- Water capacity (humidifier tub): 380 mL.
- Power supply unit: 65W AC adaptor, with an AC input range of 100-240V, 50-60Hz, 2.0A (115V, 400Hz, 1.5A for aircraft use) and a DC output of 24 VDC ± 1 VDC, 2.71A.
- Operating temperature: +41°F to +95°F (+5°C to +35°C).
- Operating humidity: 10 to 95% relative humidity, non-condensing.
- Operating altitude: Sea level to 9,870' (3,010 m); air pressure range 1060 hPa to 700 hPa.
- Air filter: Standard (Polyester non-woven fiber, >75% average arrestance) and Hypoallergenic (Blended synthetic fibers in a polypropylene carrier, >80% average efficiency).
- Bluetooth: Bluetooth Low Energy (BLE), 2400 to 2483.5 MHz frequency, +4 dBm max RF power output, 10 m (Class 2) operation range.
- Cellular module: Supports 2G, 3G, and 4G LTE Cat 1 bands (frequencies and max RF power output vary by band).
- Design life: Device and power supply unit: 5 years; Standard humidifier tub and air tubing: 6 months.
Usage Features:
- Initial Setup: The device guides users through an initial setup process via the touch screen, prompting them to select "USER" and follow instructions.
- Navigation: The touch screen allows users to "Swipe" up or down to view menu options and "Tap" to select or adjust parameters.
- Therapy Start/Stop: Therapy can be started by pressing the Start therapy/Standby button or by breathing normally if SmartStart™ is enabled. It can be stopped by removing the mask or pressing the Start therapy/Standby button, or automatically if SmartStop is enabled.
- Personalized Settings: Users can adjust settings such as Ramp Time (period for pressure to increase to prescribed level), Pressure Relief (EPR) for easier exhalation, SmartStart™ for automatic therapy initiation, and SmartStop for automatic therapy cessation.
- Climate Control: When used with the HumidAir™ 11 tub and ClimateLineAir™ 11 heated tubing, this feature provides constant temperature and humidity. It can be set to "Auto" (recommended default, 80ºF/27ºC tube temperature, 85% relative humidity, rainout protection) or "Manual" (allows independent adjustment of temperature and humidity, but rainout protection is not guaranteed).
- Humidity Level: Adjustable from Off to 8 (highest humidity) to address dry nose/mouth or mask moisture.
- Therapy Data: The device records therapy data, which can be viewed by care providers via wireless transmission (cellular communication) or an SD card (if provided). Data transfer occurs after therapy stops, requiring the device to be connected to power and not in Airplane Mode.
- myAir App: A smartphone app (available on App Store® and Google Play®) that guides users through setup, mask fitting, therapy trials, and sleep health tracking. The app connects via Bluetooth®.
- Airplane Mode: A feature to disable wireless communication when traveling by plane.
Maintenance Features:
- Daily Cleaning: Empty and wipe the humidifier tub with a clean disposable cloth, allowing it to dry out of direct sunlight. Refill with distilled water.
- Weekly Cleaning: Wash the humidifier tub, air tubing, and outlet connector in warm water with household dishwashing liquid (not exceeding 149°F/65°C), or use a solution of 1 part vinegar to 9 parts water for the tub and connector. Rinse thoroughly and allow to dry out of direct sunlight or heat. Wipe the exterior of the device with a dry cloth. The humidifier tub is dishwasher-safe (delicate cycle, top shelf only). Heated air tubing should not be washed in a dishwasher or washing machine.
- Checking Components: Regularly inspect the humidifier tub for leaks, cracks, cloudiness, pitting, or torn seals. Check air tubing for holes, tears, or cracks.
- Air Filter Replacement: Replace the air filter every six months, or more often if there are holes or blockages. The air filter is not washable or reusable.
- Troubleshooting: The manual provides solutions for common issues like air leaks, dry/blocked nose, water droplets, dry mouth, black screen, humidifier tub leaks, and data transmission problems.
- Servicing: ResMed recommends inspection and servicing by an authorized ResMed Service Centre if there are signs of wear or functional concerns. Otherwise, routine service is not typically required during the device's design life.
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