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EN-18
Manufacturer’s declaration-electromagnetic immunity
FORA IR20/IR21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
The customer or the user of FORA IR20/IR21 should assure that it is used in the environment specified below.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment-guidance
(for home healthcare and professional healthcare environment)
Electrostatic discharge (ESD)
IEC 61000-4-2
Contact: ±8 kV
Air ±2 kV, ±4 kV, ±8 kV, ±15 kV
Contact: ±8 kV
Air ±2 kV, ±4kV, ±8 kV, ±15 kV
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 for power supply lines
±1 kV for input/output lines
Not applicable
Not applicable
Mains power quality should be that of a typical home and
professional healthcare environment.
Surge IEC 61000-4-5
±0.5 kV, ±1 kV line(s) to line(s)
±0.5 kV, ±1 kV, ±2 kV line(s) to earth
Not applicable
Not applicable
Mains power quality should be that of a typical home and
professional healthcare environment.
Voltage Dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Voltage dips:
0 %
U
T
; 0,5 cycle
0 %
U
T
; 1 cycle
70 %
U
T
; 25/30 cycles
Voltage interruptions:
0 %
U
T
; 250/300 cycle
Voltage dips:
Not applicable
Not applicable
Not applicable
Voltage interruptions:
Not applicable
Mains power quality should be that of a typical home healthcare
and professional healthcare environment. If the user of FORA
IR20/IR21 requires continued operation during power mains
interruptions, it is recommended that FORA IR20/IR21 be
powered from an uninterruptible power supply or a battery.
Power frequency (50, 60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
FORA IR20/IR21 power frequency magnetic fields should be
at levels characteristic of a typical location in a typical home
healthcare and professional healthcare environment.
NOTE
U
T
is the a.c. mains voltage prior to application of the test level.