Please read this instruction manual completely before using the Melio Leg Bag System for the first time.

Please read this instruction manual completely before using the Melio Leg Bag System for the first time.

Intended Use The Melio Leg Bag System is a urine collection device designed to be installed and operated by adults who use indwelling, sheath, or suprapubic catheters. The Melio Leg Bag System has a range of design features and accessories to help users manage their urine collection including: A discharge pump at the bottom of the bag instead of a drainage tap. A rechargeable controller unit provides power to the pump and alerts the user via a beep, vibration and/or lights when the bag is 2/3 full. The user then activates the pump to empty the collection bag automatically. Please be sure to read all instructions before using your Melio Leg Bag System. You may also watch the enclosed training video (Included in Controller box). It is also available to watch online at www.meliolegbag.com. The company accepts no liability for any injury or loss that may arise if this product is used in a manner contrary to company s current recommendations. Warnings Electrical Shock Hazard. Do NOT immerse the controller or charger in water or in any other liquid. Do not use the controller in the bath or shower. Only use the charger and cord supplied with the controller. Do not open the controller. The controller battery is not replaceable. Do not remove the battery. Always keep the Melio Leg Bag lower than your bladder to facilitate gravity drainage. Failure to keep the leg bag in the proper position can slow bladder emptying, cause discomfort and potentially increase infection risk. The leg bag, pump, tubing, and cable are sterile if package is unopened and undamaged. The controller is not sterile. The Leg Bag is designed for single use and not suitable for re-sterilization. Re-use of the single use product may create a potential harm to the user. Reprocessing, washing, disinfection and sterilization may compromise product characteristics, causing additional risk of physical harm to or infection of the user. Only connect the Melio Leg Bag controller cable to a controller. Do not use the controller when it is connected to the mains supply. Do not use bags or tubing after the expiry date (this is shown on the individual packaging). No modifi cation of the Melio Leg Bag system is allowed. Cautions Wash your hands thoroughly before and after you work with the leg bag. Do not a take Melio Leg Bag System out of the packaging before you are ready to use it. Do not use a leg bag if the packaging is damaged. The bags should be changed every 7 days, when dirty or damaged, or sooner when advised by a healthcare professional. Do not disconnect the pump from the leg bag. Do not touch the connector at the top of the connecting tube or allow it to touch anything other than the urinary catheter. <#> If the discharge tube is lowered below the level of the pump and the outlet cap is open, fl uid will fl ow out of the bag. Do not allow the controller battery to completely discharge; the pump will not have power to empty the bag and you will need to empty the leg bag via gravity to drain the bag. If the low battery alert activates, charge your controller as soon as practical. Do not drop the controller as this may cause damage. Do not submerge the pump in water or any other fl uids. Store and transport in clean, dry conditions at temperatures between 41ºF and 104ºF(5ºC and 40ºC) and humidity between 15% and 93%. Use at temperatures between 41ºF and 104ºF (5ºC and 40ºC) and humidity between 15% and 93%. If the product is used at 40 C then the temperature of the bag and pump may reach 41.9 C whilst the bag is being emptied. Dispose of the Melio Leg Bag System in accordance with applicable laws and regulations. Contains or Presence of Phthalates. 2

Self-Emptying Leg Bag System REF D1002 Albert Medical Devices Ltd. Liverpool, UK LV3 1SU Best Practice for Infection Prevention Wash hands before and after handling the Melio Leg Bag System. Minimize the number of times you open the system (disconnecting the drainage bag from the urinary catheter). Keep the drainage bag below the level of the bladder. Empty the leg bag when it is 2/3 full (or less). Do not let the bag or tube openings touch any surface: toilet, counter, wall, fl oor. Regularly ensure urine is fl owing freely into the drainage bag (no kinks or twists in the system). Melio Leg Bag The Melio Leg Bag has a standard 500 ml capacity. The fl uid level sensor is a small electrical cable inside the bag that monitors the level of fl uid. It activates the alert when the leg bag is approximately 2/3 full. The pump is part of the bag and is powered by the battery in the controller. It operates after pressing and holding either of the two gray buttons on the controller or by positioning the magnetic wristband in front of the controller. The pump will automatically shut off after 3 minutes of use. Your Melio Leg Bag System includes: Controller cable connector Controller Night bag hanger Controller cable Needleless sample valve Inlet tube Thigh strap Discharge tube with end cap 500 Night bag 400 300 200 100 50 Fluid level sensor Magnetic wristband Silicone connector melio 20cm M Charger Pump Extension Tube Extra leg straps Part Number Description Approval Z1001 Melio System Controller CE D1002 Melio System Leg Bag 20cm CE 0088 D1003 Melio System Leg Bag 30cm CE 0088 B1000 Melio System Silicone Connector CE B1003 Melio System Thigh Strap CE B1004 Melio System Leg Strap CE B1023 Melio System Night Bag CE 0197 B1024 Melio System Extension Tube CE 0197 B1041 Melio System Bed Hanger for Night Bag CE 3

Melio Leg Bag Controller The leg bag controller powers the leg bag pump via a rechargeable battery. It alerts you via vibration, lights and/or beeps when the leg bag is 2/3 full. The power ON/OFF, optional audible alarm, and pump ON buttons are located on the controller. The controller has a clip on the back to attach it to your waistband. Keep the controller ON when it is connected to the leg bag to enable the alerts and to power the drainage pump. OFF OFF ON ON To turn the controller ON, slide the controller switch down (bottom position). To turn OFF, slide the switch up (top position). The controller will vibrate and both lights will blink when switched on. To turn the audio alarm ON, slide the audio switch down (bottom position). To turn OFF, slide the switch up (top position). When the leg bag is 2/3 full, the controller will vibrate and the yellow light will fl ash; there is also an audio setting, which can be turned ON or OFF. The controller will vibrate and sound 5 beeps every 3 minutes until the leg bag is emptied or you turn the controller off. Melio Leg Bag Controller Alerts The chart below explains the controller alerts. Controller must be ON for alerts to work. Alerts Meaning Resolution Flashing green light Controller vibrates briefl y every 10 minutes Single beep every 10 minutes (if audio ON) Battery needs charging. Bag can be emptied ~ 10 more times before the battery runs out. Charge battery Solid green light Battery fully charged Unplug charger Green and yellow lights fl ash once Controller vibrates briefl y Single beep (if audio is ON) <#> Confi rms power ON None needed Yellow light fl ashes Controller vibrates Five beeps (if audio is ON) Leg bag is 2/3 full Empty leg bag Yellow light fl ashes 6 times Six beeps (if audio is set to ON) Controller vibrates briefl y Pumping will start in 4 seconds when user activates the pump with the controller None needed 4

Setting up the Melio Leg Bag System Charge the controller battery for 16 hours before using for the fi rst time. While a full battery charge can last up to a week, we recommend charging the battery at least twice a week, while you are sleeping to establish a simple routine that eliminates the risk you might forget to charge. (A battery charge will typically last at least a week.) When the controller is plugged in and the battery is fully charged, the green LED will remain on continuously. When the battery is low, the green light will fl ash. To charge the controller battery: Battery charge 1 2 3 indicator light Plug the charger into an AC power supply. Connect the charge cable to the back of the controller. Allow 16 hours for a full battery charge for fi rst-time use. When the fl ashing light becomes solid green, disconnect the charge cable and the controller is ready to use. The charger connects the Melio controller to the mains power supply. The socket used for the charger must remain accessible whilst the controller is charging. In order to disconnect the controller from the mains completely, the charger should be removed from the mains socket completely. 5

Setting up the Melio Leg Bag System Wash your hands with soap and water before and after handling your leg bag. Do not let the tip of the connecting tube or end of the discharge tube touch anything, including your hands. Be sure you have an alcohol wipe to clean the connections. Open the package and inspect the leg bag system components. If any part of the packaging or system is damaged, do not use it and notify customer support. 1 2 3 Wash your hands. 4 Make sure that the cap on the discharge tube is closed. 5 Remove the cap from the connecting tube on the leg bag and clean the connector with an alcohol wipe. Place the cap on the inlet tube of the used drainage bag. 6 Attach the connector to your catheter. 7 Use the leg straps to fasten the bag securely to your calf. Tip: Switch legs each day to protect your skin. 8 Use the thigh strap to secure the inlet tube on the same side of your thigh as the leg bag. 9 Position the discharge tube and the controller power cable on the opposite side of the thigh. Adjust the thigh strap as needed. 10 <#> After dressing, position the ends of the discharge tube and the controller cable, in the waistband of your clothing (if possible). 11 Check again to ensure the cap on the discharge tube is tight. 12 Wash your hands. Insert the power cable into the back of the controller until it clicks in place. 6 Slide the clip on the back of the controller over your waistband and or belt. Turn on the controller.

Emptying the Leg Bag Automatically The controller will alert you to empty the bag when it is 2/3 full. The controller will vibrate, the lights will fl ash, and if you have set the audio to ON, it will also beep. These alerts repeat every 3 minutes until the bag is emptied or you turn the controller OFF. The best practice is to empty your leg bag when you re alerted. Have a few alcohol wipes handy in case you need them. 1 2 3 Before emptying the leg bag, wash your hands. Free the discharge tube from your waistband and remove the protective end cap. 4 5 6 Hold the discharge tube over a toilet (or alternative container). Start the drainage pump one of two ways: Press and hold down either of the push buttons on the controller. OR hold the magnetic wristband against the center of the controller. There is a 4-second delay before the pump starts. During the delay the yellow light will fl ash and the controller will vibrate briefl y. If the audio alarm is ON it will also beep. This is to alert you in case of accidental activation. Continue to activate the pump until fl uid stops coming out of the discharge tube, (typically less than 60 seconds). You can stop the pump at any time by releasing the button or moving the magnetic wrist strap away from the controller. The pump will automatically shut off after 3 minutes. 7 8 9 Once the urine is drained, wipe the end of the tube with an alcohol wipe. There s nothing wrong if a small amount of urine remains in the discharge tube after the bag has emptied. As long as the cap is snug on the tube, it will not leak. Cap the discharge tube securely and tuck it back in your waistband. Wash your hands. 7

Emptying the Leg Bag via Gravity To empty the leg bag without the pump, the leg bag must be higher than the toilet or container into which you are emptying the bag. You can either raise your leg or remove the bag from the leg. 1 2 3 Wash your hands. 4 Position the leg bag so that it is above the toilet to allow for gravity drainage. Remove the discharge tube from the thigh strap and upper leg bag strap. Position it over the toilet. Remove the discharge tube cap. Make sure the end of the tube is below the leg bag and directed into the toilet. Allow urine to drain into the toilet. 5 6 Once the urine is drained, wipe the end of the discharge tube with an alcohol wipe. Recap the discharge tube. Nighttime Use Place the discharge tubing back under the upper leg bag strap and thigh strap and tuck it into your waistband. <#> 1 2 3 Wash your hands. Follow your health care provider s advice on overnight use. You may wear the Melio Leg Bag overnight. Connect the leg bag to a night drainage bag before you go to sleep. The leg bag will drain into the night bag by gravity while you are sleeping. Using this approach, you will not have to disconnect the leg bag from your urinary catheter every night in order to change bags. Wash your hands and then empty your leg bag. Turn off the controller, remove it from your waistband, and disconnect the controller cable. Cap the controller connector cover over the controller cable connector. Store the controller in a safe location; recharge if needed. Open the thigh strap and release the discharge tube and the controller cable. You may continue to use the thigh strap to secure the urinary catheter as you wish. Remove the thigh strap only if you have another method to secure the catheter during sleep. 8

4 5 6 Attach a silicone connector to the end of the night bag tubing. Remove the leg bag discharge tube end cap and connect to the silicone connector. Urine will drain through the leg bag and into the night bag. Position the controller cable and discharge tube so they will not become entangled while you sleep. Loosen the two leg bag straps, and release the tubing and cable if desired. In the morning, simply disconnect the discharge tube from the night bag, clean the end with an alcohol wipe and replace the cap. Empty and care for your night bag as directed by your health care provider. Continue with dressing and set up the leg bag system as usual. Using the Melio System When Showering Follow your health care provider s advice on leg bag use and showering. If needed, you may keep the Melio Leg Bag in place while showering as long as you remove the controller and cover the controller cable connector with the cable connector cover. After showering, it is essential that the controller cable connector is properly dried before it is inserted back into the controller, as this could damage the controller. 1. Wash your hands. 2. Empty your leg bag. 3. Turn off the controller and disconnect the controller cable. Place the controller in a dry place. 4. To keep the controller cable connector dry, insert it into the plastic ziplock bag with the bag opening facing downward. Seal the opening. Then secure the controller cable connector, the plastic ziplock bag, and discharge tube to your thigh with the thigh strap. After showering, dry the bag before removing. 5. After showering, dry the leg bag, the discharge tube, and the controller cable. Pay special attention to drying the connector on the controller cable and the cloth backing on the leg bag. 6. Replace any wet straps with the alternate dry straps provided and allow the wet straps to air dry. 7. Continue with dressing and set up the leg bag system as usual. If bathing, do not submerge the leg bag system. Instead, hang the bag outside the bath. Keep the thigh strap on and replace it after bathing. 4 Melio Leg Bag Disposal Dispose used Melio Leg Bags according to accepted medical practice and all applicable laws and regulations. Service & Maintenance The Melio Leg Bag controller does not require any service or maintenance. If the controller needs cleaning, wipe with a damp cloth or alcohol wipe. 9

Troubleshooting Problem Possible Causes Solution The controller doesn t switch on. The pump doesn t turn on and the pump alerts (lights, vibration, beep) do not activate. The pump doesn t turn on but the alerts (lights, vibration, beep) do activate. The bag isn t filling with urine. The pump sounds like it is activated but the leg bag doesn t empty. The fill alert does not activate when the bag is 2/3 full. Controller batteries start to run out more frequently than expected Controller battery is drained. You are activating the audio alarm switch instead of the ON/OFF switch. <#> Charge the controller. Check the correct switch is being used. Controller fault. Contact technical support or your distributor details on back page. If needed, drain the leg bag via gravity. The controller is OFF. Controller cable is not properly connected to the controller. The controller battery is drained. Controller fault. Pump fault. Connecting tubing or urinary catheter is blocked. Discharge tube cap still in place. Discharge tube is pinched, twisted or otherwise blocked. Pump fault. Controller is OFF. Leg bag is not connected to the controller. The controller battery is drained. Bag fault. Controller fault. Controller is not being fully charged Controller reaching end of service life Turn the controller ON. Connect the controller cable to the controller. Charge the controller. If needed, drain the leg bag via gravity. If needed, drain the leg bag manually. Contact technical support or your distributor details on back page. Replace the leg bag with a new bag. If needed, drain the leg bag via gravity. Check for twists or kinks in the connecting tubing and correct if present. Follow your health care provider s instructions for reduced urine fl ow. Remove the cap from the discharge tube. Check for narrowing or blockage by tracing the length of the discharge tube. Correct any visible blockage. Drain the leg bag manually. If problem recurs then replace with a new leg bag. Turn the controller ON. Connect the controller cable to the controller. Charge the controller. Replace with a new leg bag, or if you prefer, you can keep using the leg bag and use the appearance and/or weight of the bag to determine when it needs emptying. You can keep using the leg bag and use the appearance and/or weight of the bag to determine when it needs emptying. Contact technical support or your distributor details on back page. Check green LED is solidly lit before disconnecting controller from charger. A full charge takes between 12-16 hours. Contact your distributor about obtaining a new Controller 10

Ordering additional supplies To order additional leg bags, please contact your distributor or visit www.meliolegbag.com. Rough guidelines on the Melio Leg Bag sizes are as follows: Height Connecting Tube Discharge Tube Medium Up to 5 ft 10 inches 8 inches (20 cm) 4 ft (120 cm) Large Over 5 ft 10 inches 12 inches (30 cm) 4 ft 5 inches (135 cm) Melio System Specifications Controller Charger: Model no. UE15WCP1-120100SPA, AC input voltage: 100-240V, 50-60 Hz, Power Output 12V 1.0A. Accredited to IEC60601-1. Controller Battery: 3.6V Nickel metal hydride rechargeable. Controller Software Version: 150303. Controller has an IP rating of IP42 (Protected against solid objects over 1 mm and direct sprays of water up to 15 from the vertical). Leg bag has an IP rating of IP23 (protected against ingress of objects >12.5mm in diameter and water spray at any angle up to 60 from vertical). Safety Classifi cation: Internal Power Source. Designed for continuous use. Leg bag (in combination with catheter) and controller are Applied parts: Type BF. The Melio Leg Bag System is designed for use between 700hPa to 1060hPa Atmospheric pressure. Leg bag, Night Bag, and Extension tubing are sterilized by Ethylene Oxide. Typical services life of the controller and charger is expected to be 3 years. Safety and Regulatory Symbols Caution. Read Instructions for Use Temperature Limits Consult Instructions For Use Lot Number Keep Dry Waste Electrical and Electronic Equipment Directive Sterilized with Ethylene Oxide Type BF Applied part Single Use Only Do not re-sterilize Do Not Use if Packaging is Damaged European Conformity Expiry/Shelf Life Power supply connection Latex Free Manufactured By DEHP Contains Phthalates M Medium L Large Follow Instructions For Use Atmospheric Pressure Limitation Humidity Limitation WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm 11

Warranty Controller/Battery Charger Certificate of Limited Warranty Albert Medical Devices guarantees that the Melio Self-Emptying Leg Bag System Controller and Battery Charger shall be free from defects in material and workmanship provided it is not modifi ed, altered, or misused. This limited warranty applies only to purchases made within the USA and is granted for a period of 1 year from the purchase date or the delivery date of the component, whichever is later. This guarantee extends only to the original purchaser and is not assignable or transferable. The sole obligation of Albert Medical Devices under this warranty shall be limited to replacing the defective Melio Self-Emptying Leg Bag System Controller and/or Battery Charger with a new unit. NO OTHER WARRANTIES, EXPRESS OR IMPLIED, ARE MADE. ALBERT MEDICAL DEVICES SHALL NOT BE RESPONSIBLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES. Albert Medical Devices guarantees that the Melio Self-Emptying Leg Bag System Controller and Battery Charger are fi t for the purpose and indications described in the labeling when used in accordance with the directions for use. Unless the equipment is used in accordance with such instructions, this guarantee is void and of no effect. In the unlikely event that your Melio Self-Emptying Leg Bag System Controller and Battery Charger should fail, please contact Albert Medical Devices to request a replacement free of charge. Technical Support Phone: 800-482-2907 8 am to 8 pm EST, Monday through Friday Website: www.meliolegbag.com Albert Medical Devices Ltd ic1 Liverpool Science Park, Innovation Centre, 131 Mount Pleasant, Liverpool L3 5TF Email: info@meliolegbag.com www.meliolegbag.com 2014 by Albert Medical Devices, Inc. All rights are reserved. Melio is a trademark of Albert Medical Devices, Inc. Melio C1011 Rev 1.5