ENGLISH Welcome The AirCurve™ 10 ST-A is a bilevel positive airway pressure device. WARNING Read this entire guide before using the device. CAUTION In the US, Federal law restricts this device to sale by or on the order of a physician. Indications for use AirCurve 10 ST-A The AirCurve 10 ST-A device is indicated to provide non-invasive ventilation for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnoea (OSA).
At a glance The AirCurve 10 includes the following: • Device with HumidAir™ integrated humidifier • Water tub • Air tubing • Power supply unit • Travel bag • SD card (already inserted).
About the control panel Start/Stop button Press to start/stop therapy. Press and hold for three seconds to enter power save mode. Dial Turn to navigate the menu and press to select an option. Turn to adjust a selected option and press to save your change. Home button Press to return to the Home screen.
Setup CAUTION Do not overfill the water tub as water may enter the device and air tubing. 1. With the device on a stable level surface, grip the retention clip on the back of the device and pull up to open. Note: The retention clip is shown in the open position. 2. (a) Plug the power connector into the device power inlet then (b) push down the retention clip to secure in place. Connect one end of the power cord into the power supply unit and the other end into the power outlet. 3.
Starting therapy 1. Fit your mask. 2. Press Start/Stop or breathe normally if SmartStart™ is enabled. You will know that therapy is on when the Monitoring screen is displayed. The pressure bar shows the inspiratory and expiratory pressures in green. The green bar will expand and contract as you breathe in and out. The screen will go black automatically after a short period of time. You can press Home or the dial to turn it back on.
Power save mode Your AirCurve 10 device records your therapy data. In order to allow it to transmit the data to your care provider, you should not unplug the device. However, you can put it into power save mode to save electricity. To enter power save mode: • Press and hold Start/Stop for three seconds. The screen goes black. To exit power save mode: • Press Start/Stop once. The Home screen is displayed.
Ramp Down Ramp Down is intended to make stopping therapy more comfortable by reducing your pressure over a fixed 15 minute period. This option will only be available to you via your care provider. To enable Ramp Down: 1. In My Options, turn the dial to highlight Ramp Down and then press the dial. 2. Turn the dial to select On and then press the dial to save the change. To start Ramp Down: 1. Press the Start/Stop button.
Mask Fit Mask Fit is designed to help you assess and identify possible air leaks around your mask. To check Mask Fit: 1. Fit the mask as described in the mask user guide. 2. In My Options, turn the dial to highlight Run Mask Fit and then press the dial. The device starts blowing air. 3. Adjust the mask, mask cushion and headgear until you get a Good result. To stop Mask Fit, press the dial or Start/Stop. If you are unable to get a good mask seal, talk to your care provider.
Muting activated alarms To mute the alarm: 1. Press the dial. A list of activated alarms will appear and the flashing alarm mute icon will be displayed in the top right corner of the screen. The alarm will be muted for 2 minutes. 2. To return to the previous screen, highlight OK and press the dial. Once the condition that activated the alarm is corrected, the alarm sound and flashing icon will stop. If the condition that activated the alarm remains after 2 minutes, the alarm will re-occur.
Caring for your device It is important that you regularly clean your AirCurve 10 device to make sure you receive optimal therapy. The following sections will help you with disassembling, cleaning, checking and reassembling your device. Disassembling 1. Hold the water tub at the top and bottom, press it gently and pull it away from the device. 2. Open the water tub and discard any remaining water. 3. Hold the cuff of the air tubing and gently pull it away from the device.
• Remove any white powder deposits using a solution of one part household vinegar to 10 parts water. 2. Check the air tubing and replace it if there are any holes, tears or cracks. 3. Check the air filter and replace it at least every six months. Replace it more often if there are any holes or blockages by dirt or dust. To replace the air filter: 1. Open the air filter cover and remove the old air filter. The air filter is not washable or reusable. 2.
SD card An alternative way for your therapy data to be transferred to your care provider is via the SD card. Your care provider may ask you to send the SD card by mail or to bring it in. When instructed by your care provider, remove the SD card. Do not remove the SD card from the device when the SD light is flashing. To remove the SD card: 1. Open the SD card cover. 2. Push in the SD card to release it. Remove the SD card from the device.
To turn on Airplane Mode: 1. In My Options, turn the dial to highlight Airplane Mode and then press the dial. 2. Turn the dial to select On and then press the dial to save the change. The Airplane Mode icon is displayed at the top right of the screen. CAUTION Do not use the device with water in the water tub on a plane due to the risk of inhalation of water during turbulence. Troubleshooting If you have any problems, have a look at the following troubleshooting topics.
Problem/possible cause Solution Air pressure in my mask seems too low (it feels like I am not getting enough air) Ramp may be in progress Wait for air pressure to build up or turn Ramp Time off. . Ramp Down may be in progress . Press Start/Stop to stop therapy then press Start/Stop to restart and continue therapy. Non-vented mask is used. Only use a vented mask. Mask vents might be blocked. Check if you have sufficient venting. Unblock mask vents if necessary.
Problem/possible cause Solution Data transfer is not enabled for your device. Talk to your care provider about your settings. My screen and buttons are flashing but there is no alarm sound or message Software upgrade is in progress. Software upgrade takes approximately 10 minutes to complete. Displays message: Read only card, please remove, unlock and re-insert SD card SD card switch may be in the lock (read-only) position.
Problem/possible cause Solution Displays message: Apnea detected The device detects an apnea that has exceeded the pre-set alarm. Breath normally to disable the alarm. If the problem persists contact your care provider. Displays message: Low Sp02 detected SpO2 has dropped below the pre-set alarm level. Check the attachment of the sensor. If the problem persists contact your care provider.
Reassembling parts Some parts of your device are designed to easily come off in order to avoid damage to the parts or the device. You can easily reassemble them as described below. To insert the water tub seal: 1. Place the seal into the lid. 2. Press down along all edges of the seal until it is firmly in place. To reassemble the water tub 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.
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. • Keep the power cord away from hot surfaces.
• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the device, the humidifier or air tubing. These solutions may cause damage or affect the humidifier performance and reduce the life of the products. • If you use the humidifier, always place the device on a level surface lower than your head to prevent the mask and air tubing from filling with water.
Sound Pressure level measured according to ISO 80601-2-70:2015 (CPAP mode): SlimLine: 27 dBA with uncertainty of 2 dBA Standard: 27 dBA with uncertainty of 2 dBA SlimLine or Standard and humidification: 30 dBA with uncertainty of 2 dBA Power level measured according to ISO 80601-2-70:2015 (CPAP mode): SlimLine: 35 dBA with uncertainty of 2 dBA Standard: 35 dBA with uncertainty of 2 dBA SlimLine or Standard and humidification: 38 dBA with uncertainty of 2 dBA Declared dual-number noise emission values in acc
Operating pressure range S, ST, T, PAC, iVAPS: CPAP 3 to 30 cm H2O 4 to 20 cm H2O Supplemental oxygen Maximum flow: 15 L/min (S, ST, T, PAC, CPAP), 4 L/min (iVAPS) Pneumatic flow path 1. Flow sensor 2. Blower 3. Pressure sensor 4. Mask 5. Air tubing 6. Water tub 7. Device 8. Inlet filter Design life Device, power supply unit: Cleanable water tub: Standard water tub, air tubing: 5 years 2.5 years 6 months General The patient is an intended operator.
Notes: • The manufacturer reserves the right to change these specifications without notice. • The electrical connector end of the heated air tubing is only compatible with the air outlet at the device end and should not be fitted to the mask. • Do not use electrically conductive or antistatic air tubing. • The temperature and relative humidity settings displayed are not measured values.
Pressure accuracy - CPAP Maximum static pressure variation at 10 cm H2O (10 hPa) according to ISO 80601-2-70:2015 Without humidification With humidification Standard air tubing ± 0.5 cm H2O (± 0.5 hPa) ± 0.5 cm H2O (± 0.5 hPa) SlimLine air tubing ± 0.5 cm H2O (± 0.5 hPa) ± 0.5 cm H2O (± 0.
20 BPM Breath rate 10 BPM 15 BPM 20 BPM -0.25, 0.02 / -0.25, 0.02 / -0.34, 0.02 / -0.36, 0.02 / -0.36, 0.03 / 0.52, 0.01 0.58, 0.01 0.62, 0.01 0.67, 0.02 0.69, 0.02 Expiratory pressure (cm H2O [hPa]) (Means, Standard Deviations) 0.36, 0.02 / 0.40, 0.02 2 -0.28, 0.01 / 0.43, 0.01 -0.24, 0.02 / 0.37, 0.01 0.05, 0.21 / 0.38, 0.01 25 -0.27, 0.01 / 0.30, 0.01 -0.33, 0.01 / 0.36, 0.01 -0.43, 0.02 / 0.45, 0.01 6 -0.30, 0.03 / 0.50, 0.01 -0.29, 0.02 / 0.47, 0.01 -0.31, 0.02 / 0.50, 0.02 12 -0.30, 0.01 / 0.
Environmental information This device should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse and recycling systems available in your region. The use of these collection, reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment. If you need information on these disposal systems, please contact your local waste administration.
Warranty claims on defective product must be made by the initial consumer at the point of purchase. This warranty replaces all other expressed or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.