33
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below.
The customer or the user of this device 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
±2 kV, ±4 kV, ±6 kV, ±8 kV
contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Floors should be wood,
concrete or ceramic
tile. If floors are cov-
ered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast
transients/bursts
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
*1
IEC 61000-4-5
AC/DC power
±0.5 kV, ±1 kV line(s) to
line(s)
±0.5 kV, ±1 kV, ±2 kV line(s)
to earth
Signal input/output
±2 kV line(s) to earth
AC/DC power
±0.5 kV, ±1 kV line(s) to line(s)
±0.5 kV, ±1 kV, ±2 kV line(s) to
earth
Signal input/output
±2 kV line(s) to earth
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply lines
*1
IEC 61000-4-11
dips
0%
U
T
: 0.5 cycle (at 0, 45,
90, 135, 180, 225, 270, 315°)
0%
U
T
: 1 cycle (at 0°)
70%
U
T
: 25/30 cycles (at 0°)
25 (50 Hz)/30 (60 Hz)
short interruptions
0%
U
T
: 250/300 cycles
250 (50 Hz)/300 (60 Hz)
dips
0%
U
T
: 0.5 cycle (at 0, 45, 90,
135, 180, 225, 270, 315°)
0%
U
T
: 1 cycle (at 0°)
70%
U
T
: 25/30 cycles (at 0°)
25 (50 Hz)/30 (60 Hz)
short interruptions
0%
U
T
: 250/300 cycles
250 (50 Hz)/300 (60 Hz)
Mains power quality
should be that of a
typical commercial or
hospital environment.
If user of this device
requires continued
operation during power
mains interruptions, it
is recommended that
this device be powered
from an uninterruptible
power supply or a bat-
tery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m (r.m.s.)
50 Hz or 60 Hz
30 A/m (r.m.s.)
50 Hz or 60 Hz
Power frequency mag-
netic field should be at
levels characteristic of
a typical location in a
typical commercial or
hospital environment.
NOTE 1:
U
T
is the a.c. mains voltage prior to application of the test level.
NOTE 2: r.m.s.: root mean square
*1: The test is not applicable since the EUT does not have AC ports.
Operation 2018-10-21
