Medela Symphony - Page 45

Electromagnetic immunity
The Symphony electric breastpump is intended for use in the electromagnetic environment
specified below. The customer or the user of the Symphony electric breastpump should assure
that it is used in such an environment.
The Symphony breastpump has no Essential Performance but was tested for immunity to
electromagnetic disturbances and passed using the following criteria:
•Change of operation mode except reset into standby mode (pump is switched off)
• Change of pressure value more than 20 mmHg (the specified tolerance), when the EUT
is operated as intended
•Change in programmable parameters, including mode and suction level
•Error codes, including the following:
-Error indicated; no further restriction in device performance
-Error indicated, the pump turns off but is restartable
-No error indicated; the pump turns off and is not restartable
•Permanent hardware failure is induced in the EUT
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic discharge
( ESD )
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
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
± 1 kV line( s ) to
line(s)
± 2 kV line( s ) to earth
± 1 kV differential
mode
± 2 kV common
mode
Mains Power quality
should be that of a
typical commercial or
hospital environment.
Electromagnetic Compatibility (EMC, IEC 60601-1-2:2007, Table 2)
Questions? Visit www.medela.com or call us at 1-800-435-8316.
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