Devilbiss Aloha Nasal Pillow System with Headgear

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• Warnings:
  - In the USA, federal law restricts this mask to sale by, or on the order of, a physician. (Rx ONLY) The device should be used only with the ventilation system recommended by your physician or respiratory therapist. A mask should not be used unless the ventilation system is turned on and operating properly. The exhalation ports should never be blocked. Explanation of warning: Ventilation systems are intended to be used with special masks with exhalation ports to allow a continuous flow of air out of the mask. When the ventilation system is turned on and functioning properly, new air from the ventilation system flushes the exhaled air out through the exhalation ports. However, when the ventilation system is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation. This warning applies to most models of ventilation systems. If you experience any reaction or notice any redness or irritation of your skin, discontinue use and contact your physician. The device consists of silicone, polycarbonate, polypropylene, polyethylene, nylon, polyester, and polyurethane. This device is intended for single-patient use only and thus use by multiple patients is to be avoided due to the risk of transmitting infection. Do not attempt to sterilize or use disinfectants on this device or any of its components.
• Cleaning Instructions After Each Use:
  - Remove the Headgear from the device by sliding each curved hook out of the Reservoir. The Headgear should be handwashed following the remaining instructions at least every 7 days. Do not machine wash.
  - Disassemble the Reservoir from the Tube Assembly by holding the Elbow and peeling away the Reservoir.
  - NOTE: Do not pull on the tubing to remove the Reservoir or the circuit tube, as this may damage the tubing.
  - Handwash all components in warm, soapy water.
  - NOTE: Only use pure soap and do not use alcohol, petroleum products, or strong cleaners as these may cause damage and reduce the life of the product.
  - Make sure that the exhalation ports on the Elbow are free of any obstructions.
  - Rinse thoroughly and shake excess water from interior surfaces of components. Allow all components to completely air-dry, away from direct sunlight.
  - Carefully inspect each component for any wear or damage. Discontinue use if you notice any cracks in the plastic, any tears or hardening of the silicone, or significant fraying or loss of elasticity of the headgear, and contact your healthcare provider for a replacement. Discoloration is normal after several washings and should not be considered sign of wear
• Fitting the Device:
  - Clean and thoroughly dry your face before putting on the interface
  - Turn on your ventilation system and make sure it is functioning properly
  - Attach the circuit tube of the ventilation system to the Swivel Coupling
  - The angle of the Reservoir may be adjusted by changing its position on the hooks of the Headgear. It is best to start with the hooks engaged into the Reservoir channels as far as possible and then to rotatable adjust the hooks outward as needed. Note that the hooks have four position marks and take care that the hooks on both sides of the Headgear are let out equally. Note that If the fourth position mark is showing significantly outside of the channel, reinsert the hook as it is not properly assembled in the channel
  - Pull the Headgear on over the top of your head and insert the Pillows into your nose. First adjust the back straps of the Headgear. Second adjust the top straps. Continue to adjust all straps until the interface fits comfortably on your face with minimal air leakage. NOTE: The side straps and the back straps should be worn close to the ears. NOTE: The back straps should be on the lower part of the head closer to the neck, not near the top of the head
  - Breathe normally, and continue making minor adjustments until you have a comfortable fit with minimal leaks. If you are unable to achieve a comfortable fit or resolve leaks at the nose, you may need an alternative Pillow size. You may also select a different slot in the Headgear for the top strap to achieve a better fit
  - The device can be worn with the Tubing on your chest or over your head (using the Velcro Ring) as you prefer
  - To remove the interface, you usually do not need to release the straps. Just grasp the Reservoir and pull it forward until it clears your nose, and then lift the interface off over your head
• Assembling the Device:
  - Prior to use, clean the device as described in the cleaning instructions
  - Select the size of Pillows that are appropriate for your nose
  - Insert the Inlet of the Tube Assembly into the Pillows Reservoir. NOTE: The outer flange on the Inlet should stop against the flange on the Reservoir
  - Note that the Reservoir has a size marking (either SM, MD, or LG) on its curved channel on one side. Note that one of the plastic supports of the Headgear has an marking near its curved hook. Fully insert the curved hook marked with the  into the curved channel on the Reservoir that has the size marking. If this is done properly, the should face outwardly. Fully insert the remaining curved hook of the Headgear into the opposite curved channel of the Reservoir

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