Technical Documentation (Con't)
XXIX
IEC 60601-1-2, Table 202
Electromagnetic Immunity
The Medela Vario 18 AC/DC c/i are intended for use in the electromagnetic environment spe-
cified below. The customer or the user of the Medela Vario 18 AC/DC c/i should assure that
they are used in such 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 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
NOTE: UT is the a.c. mains voltage prior to application of the test level.
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV
for power
supply lines
± 1 kV
for input /
output lines
± 1 kV
differential mode
± 2 kV
common mode
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
3 A/m
Compliance
Electromagnetic
level
environment - guidance
± 6 kV contact
Floors should be wood, concrete or
± 8 kV air
ceramic tile. If floors are covered with
synthetic material, the relative humidi-
ty should be at least 30 %.
± 2 kV
Mains power quality should be that of
for power
a typical commercial or hospital envi-
supply lines
ronment.
± 1 kV
for input /
output lines
± 1 kV
Mains power quality should be that of
differential mode
a typical commercial or hospital envi-
± 2 kV
ronment.
common mode
<5 % UT
Mains power quality should be that of
(>95 % dip in UT)
a typical commercial or hospital en-
for 0.5 cycle
vironment. If the user of the Medela
Vario 18 AC/DC c/i requires conti-
40 % UT
nued operation during power mains
(60 % dip in UT)
interruptions, it is recommended that
for 5 cycles
the Medela Vario 18 AC/DC c/i be po-
wered from an uninterruptible power
70 % UT
supply or a battery.
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
3 A/m
Power frequency magnetic fields
should be at levels of a typical com-
mercial or hospital environment.