9
Guidance and manufacturer's declaration – electromagnetic immunity
The Dena Electrocardiograph is intended for use in the electromagnetic environment specified
below. The customer or the user of the Dena 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
±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
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(>60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
<5% U
T
for 0.5 cycle
40% U
T
for 5 cycles
70% U
T
for 25 cycles
<5% U
T
for 5 sec
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Dena
requires continued operation,
it is recommended that the
Dena
Electrocardiograph
be powered
from an uninterruptible power
supply or a 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 U
T
is the a.c. mains voltage prior to application of test level.
