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Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Genesis DM is intended for use in the electromagnetic environment specified below. The customer
or the user of the Genesis DM should assure that it is used in such an environment.
Immunity Test
Electrostatic Discharge (ESD)
IEC 61000-4-2
Electrical Fast Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips, Short Interruptions and Voltage
Variations on Power Supply Input Lines
IEC 61000-4-11
Power Frequency (50/60 Hz) Magnetic Field
IEC 61000-4-8
U
NOTE:
is the a.c. mains voltage prior to application of the test level.
T
P.4510EN.01
GENESIS DM CLINICAL GUIDE
IEC 60601 Test
Compliance Level
Level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
±2 kV for power supply
±2 kV for power supply
lines
lines
±1 kV for input/output
±1 kV for input/output
lines
lines
±1 kV line(s) to line(s)
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±2 kV line(s) to earth
U
U
<5%
(>95% dip
0%
T
T
in U
) for 0.5 cycle
in U
) for 0.5 cycle
T
T
U
U
40%
(60% dip
40%
T
in U
) for 5 cycles
in U
) for 5 cycles
T
T
U
U
70%
(30% dip
70%
T
in U
) for 25 cycles
in U
) for 25 cycles
T
T
U
U
<5%
(>95% dip
<5%
T
in U
) for 5 sec
in U
) for 5 sec
T
T
3 A/m
3 A/m
12/5/2007
Electromagnetic Environment
- Guidance
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.
Mains power quality should be that
(100% dip
of a typical commercial or hospital
environment. If the user of the
(60% dip
T
Genesis DM requires continued
operation during power mains
(30% dip
interruptions, it is recommended
T
that the Genesis DM be powered
(>95% dip
from an uninterruptible power
T
supply or a battery.
Power frequency magnetic fields
should be at levels characteristic of
a typical commercial or hospital
environment.
Index
81
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