Alfred SmartBag 430 User Manual Download | Manualshive

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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.

The SmartBag System is for adult use only (22 years and above).

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Summary of Contents for SmartBag 430

Page 1: ...1 User Manual FPL 2P08 02 SmartBag System Model 430 July 9 2020 ...

Page 2: ...ons For Use 6 Register The SmartBag System 6 Preparing And Wearing Your SmartBag 6 Emptying Your SmartBag 7 Removing Your SmartBag 7 Cleaning and Maintenance 8 General Cleaning Directions 8 General Maintenance 8 Troubleshooting 9 Specifications and Symbols 10 Electromagnetic Conformity Declaration 12 ...

Page 3: ...ement 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 The SmartBag System is for adult use only 22 years and above ...

Page 4: ...g the SmartBag System if peristomal skin or surrounding skin begins to experience irritation Stop using if you experience an allergic reaction to using the SmartBag System Stop using if you notice the hydrocolloid around your stoma sticking to the bag and replace the whole SmartBag System Do not remove or replace any of the batteries in the SmartBag System Do not tamper or modify any components of...

Page 5: ...ag System 1 SmartWafer SmartBaseplate Operator and or patient should replace the single use SmartWafer on average every 2 3 days 2 SmartBag Operator and or patient should replace the single use SmartBag on average every 2 3 days ...

Page 6: ... 1 Clean and dry the stoma and the surrounding skin 2 Cut the SmartWafer to your stoma size according to the provided guideline and apply onto skin 3 Roll up the drain tab of the SmartBag prior to wear and firmly press closed for 5 seconds 4 Attach your SmartBag to the SmartWafer Make sure the coupling mechanism is fully clicked closed Tip To ease application you can click the SmartBag and SmartWa...

Page 7: ...hook and loop flap together to seal the bag Removing Your SmartBag 1 Empty your SmartBag 2 Remove SmartBag by pulling away from the SmartWafer using the belt tab of the coupling system Gently remove SmartWafer by pulling from top to bottom Tip Use one hand to hold the abdominal skin taut by applying gentle pressure while using the second hand to gently pull off the wafer 3 Dispose of the SmartBag ...

Page 8: ... be cleaned at the drain tab while emptying bag by using a piece of toilet paper or wet wipe Option to use water to rinse out SmartBag depending on operator and or patient preference SmartWafer is not meant to be cleaned as once SmartWafer is stuck onto the skin it should be kept dry to prevent unnecessary absorption of liquid General Maintenance Keep the SmartBag and SmartWafer dry during storage...

Page 9: ...ice 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 Restart the SmartCare App on mobile device Log off SmartCare App on mobile device and log back in For more questions please refer to the FAQs that are listed at www 11 health For more assistance or quest...

Page 10: ...terial SmartBag EVA non woven PE SmartWafer Hydrocolloid PE foam Power SmartBag SmartWafer Lithium coin cell 3V 225mAh Communication Method BLE Module SmartBag System Service Life SmartBag 7 days SmartWafer 7 days SmartBag System Shelf Life SmartBag 8 months SmartWafer 8 months Operating Environment 10 42 C 14 107 F 10 85 R H 700 1060hPa Storage Temperature 10 32 C 14 91 F 10 90 R H 500 1060hPa Op...

Page 11: ... instructions for use Type BF applied part Keep dry Do not use if package is damaged Storage temperature limit Class II equipment degree of protection against electrical shock double insulated Storage humidity limit Non ionizing electromagnetic radiation Storage atmospheric limit Degree of protection against ingress of particulates 12 5 mm and ingress from dripping water ...

Page 12: ...sult Electromagnetic Environment Guidance Emissions Testing IEC 60601 1 2 CISPR 11 Radiated Emissions Compliant Class B The SmartBag System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 Conducted Emissions NT1 IEC 61000 3 2 Harmonic Current NT1 IEC 61000 3 3 Voltage Fluctuat...

Page 13: ... 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation dist...

Page 14: ...cinity of equipment marked with the following symbol Note 1 At 80 MHz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio...

Page 15: ...15 11 Health and Technologies Inc 8 Hughes Suite 200 Irvine CA 92618 USA ...

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