Saadat Dena 640 User Manual page 77

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
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% U
(>95% dip in U
for 0.5 cycle
Voltage dips,
40% U
short
(>60% dip in U
interruptions and
for 5 cycles
voltage
variations on
70% U
power supply
(30% dip in U
input lines
for 25 cycles
IEC 61000-4-11
<5% U
(>95% dip in U
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
T
)
T
<5% U
for 0.5 cycle
T
) 40% U
T
for 5 cycles
70% U
T
) for 25 cycles
T
<5% U
for 5 sec
T
)
T
3 A/m
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.
T
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
T
Dena requires continued operation,
it is recommended that the Dena
T
Electrocardiograph be powered
from an uninterruptible 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.
9
guidance