Electromagnetic Immunity - Medela Symphony Instrucciones De Uso

Electromagnetic Compatibility (EMC, IEC 60601-1-2:2007, Table 2)

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
Electrostatic discharge
( ESD )
IEC 61000-4-2
Electrical fast transient
/ burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Questions? Visit www.medela.com or call us at 1-800-435-8316.
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input /
output lines
± 1 kV line( s ) to
line(s)
± 2 kV line( s ) to earth
Electromagnetic
Compliance
environment –
level
guidance
Floors should be wood,
concrete or ceramic tile.
± 6 kV contact If floors are covered with
± 8 kV air synthetic material, the
relative humidity should
be at least 30%.
± 2 kV for power Mains Power quality
supply lines should be that of a
± 1 kV for input/ typical commercial or
output lines hospital environment.
± 1 kV differential Mains Power quality
mode should be that of a
± 2 kV common typical commercial or
mode hospital environment.
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