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Appendix IV – EMC
Guidance and manufacturer's declaration – electromagnetic immunity
The Dena350 Electrocardiograph is intended for use in the electromagnetic environment
specified below. The customer or the user of the Dena350 should assure that it is used in such
an environment.
Immunity test
Electrostatic
±6 kV contact
discharge (ESD)
IEC 61000-4-2
±8 kV air
±2 kV for power
Electrical fast
supply lines
transient/burst
±1 kV for input/output
IEC 61000-4-4
lines
±1 kV differential
Surge
mode
IEC 61000-4-5
±2 kV common mode
<
5%
(>
95%
for 0.5 cycle
Voltage dips,
40%
short
(>
60%
interruptions and
for 5 cycles
voltage
variations on
70%
power supply
(
30%
input lines
for 25 cycles
IEC 61000-4-11
<
5%
(>
95%
for 5 sec
Power frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000-4-8
NOTE
U
is the a.c. mains voltage prior to application of test level
T
IEC 60601
Compliance
test level
±6 kV contact
±8 kV air
±2 kV for
power supply
lines
±1 kV for
input/output
lines
±1 kV
differential
mode
±2 kV
common
mode
U
T
dip in U
)
T
<
5%
for 0.5 cycle
U
T
dip in U
)
40%
T
for 5 cycles
U
70%
T
dip in U
)
for 25 cycles
T
<
5%
U
for 5 sec
T
dip in U
)
T
3 A/m
63
Electromagnetic environment -
level
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
U
T
Mains power quality should be that
of a typical commercial or hospital
U
T
environment. If the user of the
Dena350 requires continued
operation, it is recommended that
U
T
the Dena350 Electrocardiograph
be powered from an uninterruptible
U
power supply or a battery.
T
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
.
guidance
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