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Manufacturer’s guide and declaration – electromagnetic immunities
INN-011 is intended to be used in the electromagnetic environment specified below. The patient or use of INN-
011 should assure it’s used in this environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 8kV contact
± 8kV contact
Floors must be made of wood,
concrete or ceramic tiles. If the
floors are covered with synthetic
material, the relative humidity
should be at least 30%.
± 2; 4; 8; 15 kV in air
± 2; 4; 8; 15 kV
in air
Fast electrical transients /
pulse sequence
±2kV for power lines
± 2kV for power
lines
The quality of the mains voltage
should be that of a typical com-
mercial or hospital environment.
Overvoltage
IEC 61000-4-5
± 0,5; 1kV between
phases
±0,5; 1kV between
phases
The quality of the mains voltage
should be that of a typical com-
mercial or hospital environment.
Voltage dips, brief
interruptions and voltage
variations on the power
input lines
IEC 61000-4-11
0% UT per 0,5 cycles
0% UT per 0,5
cycles
The quality of the mains voltage
should be that of a typical com-
mercial or hospital environment.
If the user of INN-011 requires
continued operation during
power mains interruptions, it is
recommended to use INN-011
with a UPS or batteries.
0% UT per 1 ciclo
0% UT per 1 ciclo
70% UT per 25 cycles
70% UT per 25
cycles
0% UT per 250 cycles
0% UT per 250
cycles
High frequeny electroma-
gnetic field (50/60Hz)
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should have features of a typical
location in a commercial or
hospital environment.
NOTE U
T
is the mains voltage before applying the test level.
