19
EMC Declaration
Guidance and Manufacturer's Declaration
–
Electromagnetic Immunity
This blood pressure monitor is intended for use in the electromagnetic environments specified below. The customer or
the user of this 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
61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV 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
±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
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
<5% UT
(>95% dip in UT) for
0.5 cycle
40% UT
(60% dip in UT) for
5 cycles
70% UT
(30% dip in UT) for
25 cycles
<5% UT
(>95% dip in UT) for
5 seconds
<5% UT
(>95 % dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT) for
5 cycles
70% UT
(30% dip in UT) for
25 cycles
<5% UT
(>95% dip in UT) for
5 seconds
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the blood pressure monitor
requires continued
operation during power
mains interruptions, it is
recommended that the
device be powered from an
uninterruptible power
supply or battery.
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.
