GlucoRx AiDEX RC2101 User Manual page 97

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.
IEC 60601 test
Immunity test
level
Electrostatic
±6KV contact
discharge(ESD)
±8KV air
IEC 60601-4-2
Electrical fast
±2KV power cord
transient burst
±1KV input/output
IEC 61000-4-4
Surge IEC ±1KV line to GND
61000-4-5 ±2KV line to GND
<5% UT for 0.5
Voltage
weeks (>95% dip
dips, short
in UT) 40% UT for
interruptions
5 weeks (60% dip
and voltage
in UT) 70% UT for
variations on
25 weeks (30%
power supply
dip in UT) <5% UT
input lines IEC
for 5s (>95% dip
61000-4-11
in UT)
Power frequen-
cy (50/60 Hz)
3A/m
magnetic field
IEC 61000-4-8
immunity
Compliance level
±6KV contact
±8KV air
±2KV power cord
±1KV input/output
±1KV line to GND
±2KV line to GND
<5% UT for 0.5
weeks (>95% dip
in UT) 40% UT for
5 weeks (60% dip
in UT) 70% UT for
25 weeks (30% dip
in UT) <5% UT for
5s (>95% dip in
UT)
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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