Microtech AiDEX User Manual page 62

Continuous glucose monitoring system
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IEC 60601-1-2: Table 202
Guidance and manufacturer's declaration - electromagnetic
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 test
Electrostatic
discharge(ESD)
IEC 60601-4-2
Electrical fast
transient burst
IEC 61000-4-4
Surge IEC
61000-4-5
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
Power frequen-
cy (50/60 Hz)
magnetic field
IEC 61000-4-8
58
immunity
IEC 60601 test
Compliance level
level
±6KV contact
±6KV contact
±8KV air
±8KV air
±2KV power cord
±2KV power cord
±1KV input/output
±1KV input/output
±1KV line to GND
±1KV line to GND
±2KV line to GND
±2KV line to GND
<5% UT for 0.5
<5% UT for 0.5
weeks (>95% dip
weeks (>95% dip
in UT) 40% UT for
in UT) 40% UT for
5 weeks (60% dip
5 weeks (60% dip
in UT) 70% UT for
in UT) 70% UT for
25 weeks (30%
25 weeks (30% dip
dip in UT) <5% UT
in UT) <5% UT for
for 5s (>95% dip
5s (>95% dip in
in UT)
UT)
3A/m
3A/m
Electromagnetic environment
- guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Mains power quality should
be that of a typical commer-
cial or hospital environment.
If the user of the device
requires continued operation
during power mains inter-
ruptions, it is recommended
that the device be powered
from an uninterruptible power
supply or a battery.
The power frequency
magnetic field should have
the characteristics of power
frequency magnetic field level
at atypical place in a typical
commercial and hospital
environment

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