Spectra S1 Plus - Electromagnetic Compatibility (EMC)

Spectra S1 Plus / S2 Plus Breast Pump Instructions for Use
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TABLE 1: Electromagnetic Emissions (IEC 60601-1-2:2007)
This equipment is intended for use in the electromagnetic environment specified below. It is the responsibility of the user
of the Spectra S1 Plus or Spectra S2 Plus breast pump to ensure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - Guidance
RF emissions
CISPR 11
Group 1
This equipment uses RF energy only for internal function. Its RF
emissions thus are very low and are not likely to cause interference with
nearby electronic equipment.
RF emissions
CISPR 11
Class B
This equipment is suitable for use in all establishments, including domestic
establishments and those directly connected to public low-voltage power
supply networks that supply buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations / Flicker emissions
IEC 61000-3-3
Complies
TABLE 2: Electromagnetic Immunity (IEC 60601-1-2:2007)
This equipment is intended for use in the electromagnetic environment specified below. It is the responsibility of the user
of the Spectra S1 Plus or Spectra S2 Plus breast pump to ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic
environment - Guidance
Electrostatic
discharge
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%.
Electric
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
typical of a 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
typical of a commercial or
hospital environment.
Power frequency
and magnetic
field
IEC 61000-4-8
3 A/m at 50 and 60 Hz
3 A/m at 50 and 60 Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Voltage dips and
interruptions
IEC 61000-4-11
<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 secs
U
T
= the a.c. mains voltage before
application of the test level.
<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 secs
U
T
= the a.c. mains voltage before
application of the test level.
Mains power quality should be
typical of a commercial or
hospital environment. During a
power outage, the equipment
should be powered from a battery
or other constant, appropriate
power supply.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz – 80 MHz
3 Vrms
150 kHz – 80 MHz
Portable and mobile RF
communications equipment
should be used no closer to the
Spectra S1 Plus or Spectra S2
Plus breast pump (including
cables) than the recommended
separation distance (d), based on
the following equations:
d = 1.2√P for 150 kHz – 80 MHz
d = 1.2√P for 80 MHz – 800 MHz
d = 2.3√P for 800 MHz – 2.5GHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz – 2500 MHz
3 V/m
80 MHz – 2500 MHz