Medela Clario, Instructions For Use Manual

Page: 327 / 332

EMC
Technical documentation
| 327
Electromagnetic Immunity
Clario is intended for use in the electromagnetic environment specified below� The cus-
tomer or the user of Clario 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
± 6 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
not applicable 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
line(s) to line(s)
± 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
line(s) to line(s)
not applicable
<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
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 Clario requires
continued operation during power
mains interruptions, it is recommended
that Clario be powered from an unin-
terruptible power supply or a battery�
Power frequency magnetic fields
should be at levels of a typical com-
mercial or hospital environment�
Electromagnetic Compatibility (EMC, IEC 60601-1-2:2007, Table 2)
Note:
U
T
is the a�c� mains voltage prior to application of test level�