58
IEC 60601-1-2: Table 202
Guidance and manufacturer’s declaration - electromagnetic
immunity
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
IEC 60601 test
level
Compliance level
Electromagnetic environment
- guidance
Electrostatic
discharge(ESD)
IEC 60601-4-2
±6KV contact
±8KV air
±6KV contact
±8KV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast
transient burst
IEC 61000-4-4
±2KV power cord
±1KV input/output
±2KV power cord
±1KV input/output
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Surge IEC
61000-4-5
±1KV line to GND
±2KV line to GND
±1KV line to GND
±2KV line to GND
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<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)
<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)
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.
Power frequen-
cy (50/60 Hz)
magnetic field
IEC 61000-4-8
3A/m
3A/m
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
Summary of Contents for AiDEX
Page 1: ...AiDEXTM Continuous Glucose Monitoring System User Guide MicroTech Medical Hangzhou Co Ltd...
Page 2: ......
Page 17: ...13 Sensor applicator Sensor base tape Glucose sensor Sterile packaging Sensor components...
Page 23: ...19...
Page 40: ...36 Enter the transmitter s serial number when prompted...