Medela Thopaz - Page 47

47 | Technical documentation
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 environment.
Immunity Tests
Electrostatic
Discharge (ESD)
IEC 61000-4-2
IEC 60601
test level
± 6 kV contact
± 8 kV air
Compliance
level
± 4 kV contact
± 8 kV air
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 %.
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
Voltage dips,
short interrup-
tions and voltage
variations on
power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
± 1 kV
differential mode
± 2 kV
line(s) to earth
<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
3 A/m
± 1 kV
differential mode
± 2 kV
line(s) to earth
<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
30 A/m
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 envi-
ronment. If the user of Thopaz requires
continued operation during power
mains interruptions, it is recommended
that Thopaz be powered fr
om an unin-
terruptible power supply or a battery.
Power frequency magnetic fields
should be at levels of a typical
commercial or hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.