Microtech AiDEX User Manual page 63

Continuous glucose monitoring system
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IEC 60601-1-2: Table 204
Guidance and manufacturer's declaration – electromag-
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should ensure that it is used
in such an environment.
Immunity
IEC 60601 test
test
level
Conduct-
3V(Vrms)
ed RF IEC
150kHz~80MHz
61000-4-6
10V(engineering
medical
frequency
band)
150kHz~80MHz
Radiated
RF
IEC
10V/m
61000-4-3
80MHz~2.5GHz
netic immunity
Compliance
Electromagnetic environment -
level
guidance
Portable and mobile RF communica-
tions equipment should be used no
closer to any part of the device, includ-
ing cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
3V(Vrms)
Recommended separation distance
10V
d=1.2 √P
(engineering
d=1.2 √P 80MHz~800MHz
medical
d=2.3 √P 800MHz~2.5GHz
frequency
where P is the maximum output power
band)
rating of the transmitter in watts (W)
according to the transmitter manu-
facturer and d is the recommended
separation distance in metres (m).Field
10V/m
strengths from fixed RF transmitters,
as determined by an electromagnetic
site surveya, should be less than the
compliance level in each frequency
rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
59

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