ResMed Aria Health Manual
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ResMed Aria Health Manual

Pneumatic compression system
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Aria Free™ pneumatic compression system
Brought to you by
Aria Health,
a ResMed company
Aria
: Lymphedema Management
TM

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Summary of Contents for ResMed Aria Health

  • Page 1 Aria Free™ pneumatic compression system Brought to you by Aria Health, a ResMed company Aria : Lymphedema Management...

  • Page 2: Indications For Use

    In the US, federal law restricts this system to sale by or on the order of a physician. Indications for use The Aria Free system by Aria Health is intended for use by medical professionals and patients at home for the treatment of the following conditions: Lymphedema ...

  • Page 3: Adverse Effects

    Contraindications Use of pneumatic compression may be contraindicated in some patients with the following pre-existing conditions: Congestive heart failure  Any condition where increased lymphatic and venous return is  undesirable Adverse effects The following side effects may arise during the course of using the system: Mild to moderate pain and/or discomfort ...
  • Page 4 Your Aria Free system at a glance The Aria Free system includes the following: Air pump Pneumatic garment Connector tube Power supply unit Adjusters (x7) For accessories available for use with the Aria Free system, please contact us or visit our website: AriaHealth.com...
  • Page 5 Your Aria Free system in detail Air pump Start/Stop button Air pump connection point Bluetooth button ® Air filter cover Pneumatic garment Garment connection point Self-fastening tabs Adjusters (x7) Connector strip Connector tube Power connection point Electrical line Air line grey end Vent module Air line green end Power supply unit...
  • Page 6 Your assembled system Your fully assembled system will look similar to below. Detailed Setting up and assembly instructions can be found in the section starting therapy. Note: The adjusters are not represented as they are not necessary Using Your Garment Adjusters for use.
  • Page 7 Aria: Lymphedema Management app Your Aria Free system is designed to work with the Aria: Lymphedema Management app. However, the app is not required to operate the system. For more information, refer to the section Connecting your Aria Free system and smart device within this Help Bar manual or...

  • Page 8: Setting Up And Starting Therapy

    Setting up and starting therapy If the app has been downloaded, open it and follow the step-by- step instructions. You will also find helpful videos to assist you in your first time setup. Use your Aria Free system only as directed by your physician or healthcare provider.
  • Page 9 2. Plug the power line of the power supply unit into the remaining port on the power connection point. Plug other end of the power supply unit into the power outlet on your wall. 3. After following these steps, your pump connections should look like this.
  • Page 10 Wearing your garment WARNING Do not put on the garment if your affected leg has open wounds. The system is only intended to contact intact skin. Ensure any wounds are adequately covered with wound dressing prior to use. Prepare the garment by loosening the self-fastening tabs, except the tabs around the foot and ankle.
  • Page 11 Make sure it’s tucked into the Secure the bottom underside of your leg securely. tab first. Align the connector strip on the front and center of the leg (shown by the green dotted line) when fitting. As you move your way up the Once all tabs are secured, you are garment and secure each tab, pull ready for therapy.
  • Page 12 Your garment should have a tight but not restrictive fit, like a yoga pant. It is important to avoid wearing anything underneath your garment that may hamper the lymph flow. These items include: pants with heavy seams, compression stockings, zippers. You may wear loose-fitting, non-elastic clothes, sheer liners or place the garment directly on intact skin.
  • Page 13 Adjust the foot wrap Re-secure starting Followed by the left by evenly tucking the with the right side side tab. material around the tab. foot to create a close fitting wrap. Remove any bunching that might be present. Bring the toe tab Pull heel tab away Release the ankle tab over the top.
  • Page 14 You are now ready Place heel tab back on for therapy. the garment. Note: If your toes don't reach the end of the sole, do not pull the toe tab backwards to reduce the length. This might impact the inflation received on the toes and other parts of the foot. There are different sizes available for the garment.
  • Page 15 1. Extension: To extend the self-fastening tabs in cases where the pneumatic garment does not wrap around the entire leg. See the diagram below. Once you have attached the adjusters, follow the Wearing your garment instructions found in the section achieve a good fit.
  • Page 16 Your adjusters may have covers on one side of the self-fastening tabs: 1. For extension: Keep the cover on to ensure the self-fastening tab does not come into contact with exposed skin. 2. For tightening: Remove the cover to expose both self-fastening tabs if the method 2a is used.
  • Page 17 Start therapy by pressing the Start/Stop button. Stop therapy by pressing the Start/Stop button or wait until therapy session completes. Therapy session One full therapy session will take sixty (60) minutes. Once you press the Start/Stop button, a pre-inflation cycle will commence for around 30 seconds during which different parts of the garment will slightly inflate.

  • Page 18: Ending Therapy

    Using the therapy pause feature Therapy Pause is a comfort and convenience feature. It is designed to allow you to temporarily pause therapy and disconnect the garment from the air pump. This gives you the freedom to step away from therapy without having to completely remove the garment, and then resume therapy where you left off.
  • Page 19 2. Leave the garment with the tube and air pump connected for at least 5 minutes. This will allow for some (but not all) air to be removed from your garment. 3. If you would like to store for routine use, simply disconnect the connector tube from the garment and unplug the power supply unit from the air pump.
  • Page 20 Removing air from your garment A deflation mode is available in your Aria Free system. It is designed to allow you to remove trapped air from the garment. Follow the below steps to enter this mode and use it. 1. Connect your device as you would for therapy. However, leave the garment tabs unfastened.
  • Page 21 Management app Your Aria Free system can be used with or without the Aria: Lymphedema Management app by Aria Health. The app will help keep yourself accountable by providing a timer of your therapy session and tracking your usage against a personal goal over time.
  • Page 22 4. Create an account by selecting “Sign up Now” and fill the requested information. 5. To use the app, you will need to accept Aria Health’s terms of use and privacy policies. You will also have the option to allow Aria Health to use analytics to improve the app experience.
  • Page 23 If you decide not to Settings enroll at this time, you can enroll at any time from the page. You also have the option to allow Aria Health to use your email address to send you updates on our products. Once you Next.
  • Page 24 Connect g) On your smart device, tap h) The first time you pair your Aria Free system with your smart device, will need perform the authentication procedure. i) When prompted by the app, authenticate by entering the four-digit key located on the back of the Aria Free pump. Done 10.

  • Page 25: Cleaning And Maintenance

    Cleaning and maintenance It is important that you regularly clean your Aria Free system to make sure you receive optimal therapy. The following sections will help you with disassembly, cleaning and checking your machine. The air pump has an expected life of five years based on normal daily usage.
  • Page 26 Disconnect the garment Disconnect the connector tube from the garment connection point. Remove the garment 1. Loosen the self-fastening straps. 2. Remove your limb from the garment. 3. Flatten the garment for cleaning by opening all of the self- fastening straps and placing the garment on a flat surface (with the side you want to clean facing up).
  • Page 27 WARNING  As part of good hygiene, always follow cleaning instructions. Some cleaning products may damage the equipment and affect its function, or leave harmful residue that could irritate the skin.  Regularly clean, but do not launder, your Aria Free garment, following the detailed instructions provided below.
  • Page 28 Cleaning the garment and adjusters (including cover) Wipe clean the interior of the garment and adjusters with a damp  cloth each week: o Using a clean cloth, lightly moisten it with warm water to dampen. Mild liquid detergent may be used to address difficult soiling (for example Ultra Joy Dishwashing Liquid).
  • Page 29 Change the Air pump filter Replace the filter at least every 6 months. It cannot be washed. Check and replace it more often if there are any holes or blockages caused by dirt or dust. To change the filter: 1. Slide the filter cover off and remove the old filter. 2.
  • Page 30 Traveling You can take your Aria Free system with you wherever you go. It has a universal power supply that will accept voltage standards across the world. However, make sure you have the appropriate power plug adapter for the region where you will be traveling. Please contact us or visit our website for official Aria Free travel accessories.

  • Page 31: Troubleshooting

    Troubleshooting If you have any problems, consult the following troubleshooting topics. If you are not able to fix the problem, contact customer support. Do not try to open the machine. Problem/possible cause Solution Air pressure in my garment seems too low / It feels like I am not getting enough air.
  • Page 32 Problem/possible cause Solution I cannot start therapy. Power may not be connected. Connect the power supply unit and make sure the plug is fully inserted. The green indicator light on the power supply unit should be illuminated. Check that the green indicator light above the Start/Stop button on the pump is also illuminated.
  • Page 33 Problem/possible cause Solution Garment may be the wrong size. Please contact customer support, several sizes are available for the garment. The covers on the adjusters are no longer sticking to the self-fastening tabs. The covers have been detached too many Please contact customer support.

  • Page 34: General Warnings And Cautions

     Do not open or modify the system. There are no user-serviceable parts inside. Repairs and servicing should only be performed by an authorized Aria Health service agent.  Beware of electrocution. Do not immerse the air pump, garment, power supply unit, or power cord in water. If liquids are spilled into or onto the system, unplug the system and let the parts dry.
  • Page 35 MR environment. CAUTION  Use only Aria Health parts and accessories with the system. Non- Aria Health parts may reduce the effectiveness of the treatment and/or damage the machine.  Blocking the vent module on the tubing and/or air filter cover of the machine while in operation could lead to overheating of the machine.

  • Page 36: Technical Specifications

    Technical specifications System At sea level: 0 - 45 mmHG (Single Fault: < 70 mmHG) Pressure From 0 to 1250 m: 0 - 35 mmHG From 1250 m to 2591 m: 0 - 32 mmHG Note: up to 2591 m, delivered therapy is still effective. Materials Flame-retardant engineering thermoplastic Operating...
  • Page 37  Consult the dealer or an experienced radio/TV technician for help. Any change or modification to the product is not expressly approved by Aria Health and could void the user’s authority to operate the device. FCC ID: QOQBT121, IC: 5123A-BGTBT121...
  • Page 38 Aria Health confirms that machine meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air travel. Wireless technology Technology used: Bluetooth Connection types: SPP, iAP2, GATT Frequency: 2402 to 2480 MHz Max RF power output: +4 dBm...
  • Page 39 Symbols The following symbols may appear on the product or packaging. Description Symbol Read instructions before use (IEC 60601-1) Indicates a warning or caution (IEC 60601-1) Follow instructions before use (IEC 60601-1) Manufacturer. (ISO 15223-1) European Authorized Representative (ISO 15223-1) Batch code (ISO 15223-1) Catalog number (ISO 15223-1) Serial number (ISO 15223-1)
  • Page 40 Description Symbol Temperature limitation (ISO 15223-1) Non-ionising radiation (IEC60601-1-2) Bluetooth (Bluetooth Brand guide) Prescription only (In the US, Federal law restricts these devices to sale by or on the order of a physician) (21 CFR 801) Operating altitude Atmospheric pressure limitation (ISO 15223-1) Complies with RTCA DO-160 section 21, category M.
  • Page 41 Do not dry clean. Environmental information (EU directive 2012/19/EE Waste Electrical and Electronic Equipment (WEEE)). See symbols glossary at ResMed.com/symbols. If you need information on these disposal systems, please contact your local waste administration. The crossed-bin symbol invites you to use these disposal systems. If you require information on collection and disposal of your Aria Free system please contact customer support.

  • Page 42: Limited Warranty

    If you have a medical question, please contact your healthcare provider. Limited warranty Aria Health warrants that your Aria Free product shall be free from defects in material and workmanship from the date of purchase for the period specified in the following table:...
  • Page 43 If the product fails under conditions of normal use, Aria Health will repair or replace, at its option, the defective product or any of its components. This Limited Warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product;...

  • Page 44: Guidance And Manufacturer's Declaration Electromagnetic Emissions And Immunity

    Guidance and manufacturer’s declaration electromagnetic emissions and immunity Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document. Guidance manufacturer’s declaration—electromagnetic emissions This device is intended for use in the electromagnetic environment specified below.
  • Page 45 Immunity test Compliance Electromagnetic environment — guidance level Electrostatic ±8 kV contact Floors should be wood, concrete or ceramic discharge (ESD) ±15 kV air tile. If floors are covered with synthetic IEC 61000-4-2 material, the relative humidity should be at least 30%.
  • Page 46 Conducted 10 Vrms Portable and mobile RF communications IEC 61000-4-6 150 kHz to 80 equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from equation applicable frequency of the transmitter. Radiated RF IEC 9 V/m to 85 Portable and mobile RF communications...

  • Page 47: Further Information

    Aria Free system, contact customer support at: +1 866-647-0691 PM-D-001/5.0 2021-11 Aria and Aria Free are trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual property information, see ResMed.com/ip. © 2021 Aria Health The Bluetooth®...

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