EarlySense InSight AME-01350-US, User Manual

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Manufacturer declaration
31
Table 11: Electromagnetic Immunity for Non-Life-Supporting Systems
The EarlySense InSight System is intended for use in the electromagnetic environment specified below.
The customer or the user of the EarlySense system should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level
Compliance
Level Electromagnetic Environment
– Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2 ± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air ± 8 kV contact
discharge
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
air discharge 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 ± 2 kV
100 kHz repetition
frequency ± 2 kV
100 kHz
repetition
frequency Mains power quality should be
that of a typical commercial
or hospital environment.
Surge IEC 61000-4-5 ± 0.5 kV
±1 kV
± 2 kV ± 0.5 kV
±1 kV
± 2 kV
Mains power quality should be
that of a typical commercial
or hospital environment.
Voltage dips
IEC 61000-4-11 0 % UT; 0.5 cycle
At 0%, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0% UT; 1 cycle and
70% UT; 25/30
cycles
Single phase at 0° 0 % UT; 0.5
cycle
At 0%, 45°, 90°,
135°, 180°,
225°, 270° and
315°
0% UT; 1 cycle
and 70% UT;
25/30 cycles
Single phase
at 0° Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the system requires
continued operation during
power mains interruptions, it is
recommended that the
EarlySense InSight System be
powered from an
uninterruptible power supply.
Voltage interruptions
IEC 61000-4-11 0% UT; 250/300
cycle 0% UT; 250/300
cycle
Rated Power
frequency magnetic field IEC
61000-4-8 30 A/m
50 Hz or 60 Hz 30 A/m
50 Hz or 60 Hz Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment and are not
expected to affect the
EarlySense InSight System.
NOTE
U
T
is the AC Mains voltage prior to application of the test level.