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Summary of Contents for Alfred SmartBag 430
- Page 1 User Manual FPL-2P08-02 SmartBag System Model 430 July 9, 2020...
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Page 2: Table Of Contents
Contents Indications For Use ............................3 Safety And Warnings ............................ 4 Components Of The SmartBag System ......................5 Instructions For Use ............................. 6 Register The SmartBag System ......................... 6 Preparing And Wearing Your SmartBag ....................6 Emptying Your SmartBag .......................... 7 Removing Your SmartBag ......................... -
Page 3: Indications For Use
SmartBag’s intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health’s care management platform known as alfred: SmartCare, designed for patients and medical professionals. The alfred: SmartBag System (including the SmartBag and SmartWafer), offers a continuous ostomy monitoring system and tracks the estimated volumetric filling of the bag using integrated sensor technology. -
Page 4: Safety And Warnings
Safety And Warnings Note to personnel who provide training to lay operators (i.e. patients) or lay responsible organizations: Be sure to include all the warnings below when providing training to lay operators, especially in a Home Care Environment in order to ensure the best device performance. Lay users should be instructed to contact Technical Support if there is a change in the performance of the SmartBag System. -
Page 5: Components Of The Smartbag System
Components Of The SmartBag System SmartWafer (SmartBaseplate): Operator and/or patient should replace the single-use SmartWafer on average every 2-3 days. SmartBag: Operator and/or patient should replace the single-use SmartBag on average every 2-3 days. -
Page 6: Instructions For Use
Instructions For Use Register The SmartBag System 1. Search for alfred: SmartCare from the App Store/Google Play to download and register. 2. Scan the code on the SmartBag System box to register your kit. Preparing And Wearing Your SmartBag 1. Clean and dry the stoma and the surrounding skin. -
Page 7: Emptying Your Smartbag
Emptying Your SmartBag 1. Undo the hook and loop at the bottom of your SmartBag, pinch in the edges, and empty the contents into the toilet. 2. Clean outlet with toilet paper or wet wipe. 3. Close outlet by folding the bottom upwards 3 times. On the final fold, firmly press the long hook and loop flap together to seal the bag. -
Page 8: Cleaning And Maintenance
Cleaning and Maintenance General Cleaning Directions As the SmartBag and SmartWafer are single use products, little to no cleaning is required as the SmartWafer is meant to be kept dry SmartBag may be cleaned at the drain tab while emptying bag by using a piece of toilet paper or wet wipe. -
Page 9: Troubleshooting
Troubleshooting If there are issues seeing data on the SmartCare App, here are a couple step to follow: Ensure the mobile application is connected to your Wi-Fi or on cellular data to communicate with the 11 Health Cloud Ensure that Bluetooth is enabled on your mobile device to pair with the SmartBag System Ensure the mobile device is within 10 feet of the SmartBag System Check the SmartCare App for the SmartBag System status to ensure the components are connected... -
Page 10: Specifications And Symbols
Specifications and Symbols Specifications Dimensions SmartBag – 13.59 cm (5.35”) W x 26.42 cm SmartBag System Service Life (10.40”) L with 4.25cm (1.67”) diameter SmartBag – 7 days opening SmartWafer – 7 days SmartWafer – 12.4cm (4.88”) x 12.4cm (4.88”) SmartBag System Shelf Life with 42mm (1 ”) maximum cut ring... - Page 11 Symbols Latex free Manufacturing date / Batch Code Single use only Manufacturer Caution: consult Instructions for use attached to the accompanying product documents Follow instructions for Type BF applied part Keep dry Do not use if package is damaged Storage temperature Class II equipment (degree of limit protection against electrical...
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Page 12: Electromagnetic Conformity Declaration
Electromagnetic Conformity Declaration The SmartBag System (model 430) has been built and tested according to IEC60601-1-2 and United States Federal Communications Commission (FCC) standards. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. - Page 13 Recommended separation distances between portable and mobile RF communications equipment and the SmartBag System The SmartBag System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SmartBag System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SmartBag System as recommended below, according to the maximum output power of the communications equipment.
- Page 14 385 MHz Recommended separation distance √ ���� 28 V/m d =1,17 √ ���� 80 MHz to 800 MHz 450 MHz d =1,17 √���� 800MHz to 2,7 GHz 9 V/m 710/745/780 MHz d =2,33 28 V/m where P is the maximum output power 810/870/930 MHz rating of the transmitter in watts (W) according...
- Page 15 11 Health and Technologies Inc. 8 Hughes Suite 200 Irvine, CA 92618 USA...
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