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represent actual modulation, it would be worst case.
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey,
should be less than the compliance level in each frequency range.
d
Interference may occur in the vicinity of equipment marked with the following
symbol:
d
Field strengths from fixed transmitters, such as base stations for radio (mobile/wireless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Sensor is used exceeds the applicable RF compliance level above, the Sensor should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orientating or relocating the Sensor.
e
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Performance Characteristics
Note:
Please consult your healthcare team on how to use the information in this
section.
Performance Characteristics
Performance of the Sensor was evaluated in a controlled clinical study. The study
was conducted in 4 centres and a total of 100 subjects ages 4 years and older with
diabetes were included in the e"ectiveness analysis. Each subject wore up to two
Sensors for up to 14 days on the back of the upper arm. During the study, subjects
had their venous blood glucose analysed over up to three separate visits to the
clinical centre using the Yellow Springs Instrument Life Sciences 2300 STAT Plus™.
Three lots of Sensors were evaluated in the study.
Fig 1. Comparison of the Sensors vs. YSI reference.
ART42490-004_rev-A 10:30am 04-May-22
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