4
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. Lay operators
should be instructed on inappropriate environments for use (i.e. shower, MRI environment) for the
system. For guidance on training, please contact Technical Support.
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The patient is an intended operator of the SmartBag System.
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HANDLE SMARTBAG SYSTEM WITH CARE.
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Keep away from pets and children as the SmartBag System is not a toy.
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SmartBag System is not designed to be waterproof. Showering or swimming may affect its
function.
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Do not submerge in water.
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Do not store in direct sunlight.
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Keep clean of excessive dust or lint.
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Do not use microwave to heat the SmartWafer.
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Do not bend the SmartBag or SmartWafer.
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Place mobile phone on airplane mode prior to an airplane flight.
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Stop using the SmartBag System if peristomal skin or surrounding skin begins to experience
irritation.
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Stop using if you experience an allergic reaction to using the SmartBag System.
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Stop using if you notice the hydrocolloid around your stoma sticking to the bag and replace the
whole SmartBag System.
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Do not remove or replace any of the batteries in the SmartBag System.
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Do not tamper or modify any components of the SmartBag System as it may result in inaccurate
readings.
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Do not use outside accessories that are not described in the manual as they may interfere with
the performance and accuracy of the SmartBag System (i.e. sensor detection, EMC performance).
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Remove SmartBag System before entering a magnetic resonance environment (i.e. MRI) as this
type of environment may interfere with the performance and accuracy of the SmartBag System.
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Devices of known electromagnetic interference (EMI) may interfere with the performance and
accuracy of the SmartBag System.
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Avoid use of other equipment that may cause erratic operation or degradation in the performance
of this device due to uncontrolled electromagnetic interference.
Contraindications
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Do not wear if you have electronic implants, such as pacemakers.
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Do not wear if you require a convex wafer as the SmartBag System only works with the
SmartWafer, which is flat.
