Medela Thopaz+ Gebruiksaanwijzing pagina 412
Electromagnetic compatibility
(EMC, IEC 60601-1-2:2014 4th Edition, 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
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
NOTE U
is the a�c� mains voltage prior to application of the test level�
T
412 |
Technical documentation
IEC 60601
Compliance
test level
level
± 8 kV contact
± 8 kV contact
± 15 kV air
± 15 kV air
± 2 kV
± 2 kV
for power
for power
supply lines
supply lines
± 1 kV
± 1 kV
for input /
for input /
output lines
output lines
± 1 kV
± 1 kV
differential mode
differential mode
± 2 kV
± 2 kV
line-to-earth
line-to-earth
not applicable
<0 % U
<0 % U
T
for 0�5 cycle at 0°,
for 0�5 cycle at 0°,
45°, 90°, 135°,
45°, 90°, 135°,
180°, 225°, 270°
180°, 225°, 270°
and 315°
and 315°
0 % U
0 % U
T
for 1 cycle
for 1 cycle
70 % U
70 % U
T
for 25 cycles at
for 25 cycles at
50 Hz single
50 Hz single
phase: at 0°
phase: at 0°
and for 30 cycles
and for 30 cycles
at 60 Hz single
at 60 Hz single
phase: at 0°
phase: at 0°
<0 % U
<0 % U
T
for 250 cycles at
for 250 cycles at
50 Hz
50 Hz
and for 300 cycles
and for 300 cycles
at 60 Hz
at 60 Hz
30 A/m
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
T
of a typical commercial or hospital
environment� If the user of Thopaz +
requires continued operation during
power mains interruptions, it is
recommended that Thopaz + be
powered from an uninterruptible
T
power supply or a battery�
T
T
Power frequency magnetic fields should
be at levels of a typical commercial or
hospital environment�
