Electromagnetic Compatibility (Emc) - Abbott FreeStyle Libre 2 User Manual

Additional notes for Health Care Professionals
A clinical study was conducted to evaluate the effect of ascorbic acid on Sensor performance.
Data from 57 adult subjects with diabetes was collected over a 13-hour period. Each subject had a
one-hour baseline phase where venous blood was collected every 10 minutes. After this first hour,
a dose of 1000 mg ascorbic acid was given with a meal and venous samples were collected every
20 minutes for the next four hours. A maximum average sensor bias of 9.3 mg/dL was observed
around 3 hours after the 1000 mg ascorbic acid dose. Subjects then received a second dose of
1000 mg ascorbic acid with a meal and the same process was continued for another 4 hours. A
third dose of 1000 mg ascorbic acid was then given and study subjects were followed for 4 more
hours. After the second dose of ascorbic acid the maximum average sensor bias increased, with
minimal change in sensor bias after the third dose, suggesting that saturation had occurred by the
second 1000 mg dose of ascorbic acid. The maximum average sensor bias after the three 1000 mg
doses of ascorbic acid was less than 20 mg/dL.
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Electromagnetic Compatibility (EMC)

FreeStyle Libre 2 Reader - FCC ID: QXS-LIB02
FreeStyle Libre 2 Sensor - FCC ID: QXS-LIB02S
• The System needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
• Portable and mobile RF communications equipment can affect the System.
• The use of accessories, transducers and cables other than those specified by Abbott Diabetes Care
may result in increased EMISSIONS or decreased IMMUNITY of the System.
• The System should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, the System should be observed to verify normal operation in the
configuration in which it will be used.
• 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.
• Changes or modifications not approved by Abbott could void the user's authority to operate the
equipment.
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