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Eversense E3 CGM User Guide
20
Electrical and Safety Standards (continued)
The Eversense E3 CGM System is intended to be used in the electromagnetic environment detailed in the table below.
Users of the System should ensure it is used according to these specifications.
System Electromagnetic Immunity Specifications
Immunity
Test
IEC 60601
Test Level
Transmitter
Compliance
Level
Electromagnetic
Environment
Guidance
Conducted RF
IEC 61000-4-6
(Smartphone only
(Receiving Device))
≥3 Vrms
(150 kHz to 80 MHz)
3 Vrms Interference may occur in the vicinity
of equipment marked with the
following symbol:
Radiated RF
IEC 61000-4-3
≥10 V/m at
80 MHz to 2700 MHz
(AM Modulation)
3 Vrms
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected 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 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 Eversense
E3 CGM System is used exceeds the applicable RF compliance level above, the Eversense E3 CGM System should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Eversense E3 CGM
System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
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