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Electromagnetic Immunity - Medela Thopaz+ Gebrauchsanweisung

Cardiothoracic drainage
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Electromagnetic compatibility (EMC, IEC 60601-1-2:2007, Table 2)

Electromagnetic immunity

Thopaz + is intended for use in the electromagnetic environment specified below.
The customer or the user of Thopaz + should assure that they are used in such an
environment.
Immunity Tests
IEC 60601
test level
Electrostatic
± 6 kV contact
Discharge (ESD)
± 8 kV air
IEC 61000-4-2
Electrical fast
± 2 kV
transient/burst
for power
IEC 61000-4-4
supply lines
± 1 kV
for input /
output lines
Surge
± 1 kV
IEC 61000-4-5
differential mode
± 2 kV
line(s) to earth
Voltage dips,
<5 % U
short interrup-
(>95 % dip in U
tions and voltage
for 0.5 cycle
variations on
power supply
40 % U
input lines
(60 % dip in U
IEC 61000-4-11
for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 sec
Power frequency
3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
392 |
Technical documentation
Compliance
level
± 4 kV contact
± 8 kV air
± 2 kV
for power
supply lines
± 1 kV
for input /
output lines
± 1 kV
differential mode
± 2 kV
line(s) to earth
<5 % U
T
T
)
(>95 % dip in U
T
for 0.5 cycle
40 % U
T
T
)
(60 % dip in U
T
for 5 cycles
70 % U
T
T
)
(30 % dip in U
T
for 25 cycles
<5 % U
T
T
)
(>95 % dip in U
T
for 5 sec
30 A/m
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
)
of a typical commercial or hospital
T
environment. If the user of Thopaz +
requires continued operation during
power mains interruptions, it is recom-
mended that Thopaz + be powered
)
T
from an uninterruptible power supply
or a battery.
)
T
)
T
Power frequency magnetic fields
should be at levels of a typical
commercial or hospital environment.

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