Electromagnetic Immunity - Medela Invia Motion Instrucciones De Uso

IEC 60601-1-2, Table 2

Electromagnetic Immunity

The Invia Motion NPWT System is intended for use in the electromagnetic environment
specified below. The customer or the user of Invia Motion NPWT System should as-
sure that they are used in such environment.
Immunity Tests
Electrostatic
Discharge (ESD)
IEC 61000-4-2
NOTE:
At high levels of ESD, the system may reset itself. The Invia Motion NPWT Pump will
restart on its own at correct settings without interruption of therapy and requiring no
action from the user.
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
is the a.c. mains voltage prior to application of the test level.
NOTE:
U
T
38
200_4169_ifu_invia_motion_patient_EN_ES_FR.indd 38
IEC 60601 Compliance
test level level
± 6 kV contact ± 6 kV contact
± 8 kV air ± 16.5 kV air
without power supply
± 8 kV air
with power supply
± 2 kV ± 2 kV
for power for input / output lines
supply lines
± 1 kV
for input / not applicable
output lines
± 1 kV ± 1 kV
line(s) to line(s) differential mode
± 2 kV
line(s) to earth not applicable
<5 % U <5 % U
T
(>95 % dip in U ) (>95 % dip in U
T
for 0.5 cycle for 0.5 cycle
40 % U 40 % U
T
(60 % dip in U ) (60 % dip in U
T
for 5 cycles for 5 cycles
70 % U 70 % U
T
(30 % dip in U ) (30 % dip in U
T
for 25 cycles for 25 cycles
<5 % U <5 % U
T
(>95 % dip in U ) (>95 % dip in U
T
for 5 sec for 5 sec
3 A/m 30 A/m
Electromagnetic
environment - guidance
The relative humidity should
be at least 5 %.
Mains power quality should
be that of a typical domes-
tic or hospital environment.
Mains power quality should
be that of a typical domes-
tic or hospital environment.
Mains power quality should
T
) be that of a typical domestic
T
or hospital environment. If
the user of the Invia Motion
T
NPWT System requires
)
T
continued operation during
power mains interruptions,
it is recommended the Invia
T
) Motion NPWT System be
T
powered from an uninter-
ruptible power supply or a
T
battery.
)
T
Separation distance r =
Where I is the current in
amperes in a power bus or
an appliance wire and r is
the separation distance in
meters.
I
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