Comen CM1200B - Page 66

EMC
V-2
Table 2
Guidance and manufacturer´s declaration - electromagnetic immunity
CM1200B Electrocardiograph is intended for use in the electromagnetic environment specified below. The
customer or the user of CM1200B Electrocardiograph 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
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Floors should be wood, concrete or
ceramic tie. 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
100 kHz repetition
frequency
± 2 kV for power
supply lines
± 1 kV for input/ output
lines
100 kHz repetition frequency
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 0.5kV, ± 1 kV line(s)
to lines
± 0.5kV, ± 1 kV, ± 2 kV
line(s) to earth
± 0.5kV, ± 1 kV line(s)
to lines
± 0.5kV, ± 1 kV, ± 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
input lines
IEC 61000-4-11
0 % U
T
; 0.5 cycle At
0°, 45°, 90°, 135°,
180°, 225°, 270°and
315°
0 % U
T
; 1 cycle Single
phase: at 0°
70 % U
T
; 25/30 cycles
Single phase: at 0°
0 % U
T
; 250/300 cycles
0 % U
T
; 0.5 cycle At
0°, 45°, 90°, 135°,
180°, 225°, 270°and
315°
0 % U
T
; 1 cycle
Single phase: at 0°
70 % U
T
; 25/30 cycles
Single phase: at 0°
0 % U
T
; 250/300 cycles
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
CM1200B Electrocardiograph
requires continued operation during
power mains interruptions, it is
recommended that the CM1200B
Electrocardiograph be powered
from an uninterruptible power
supply or a battery.
Power frequency
magnetic field
IEC 61000-4-8
30 A/m(50/60 Hz)
30 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Table 3
Guidance and manufacturer’s declaration - electromagnetic immunity
CM1200B Electrocardiograph is intended for use in the electromagnetic environment specified below. The
customer or the user of CM1200B Electrocardiograph should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic
environment - guidance