Ameda Platinum Instrucciones página 11

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Ameda Platinum Breast Pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the Ameda Platinum Breast Pump should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic ± 8 kV contact
discharge (ESD) ± 2 kV, ± 4 kV, ± 8 kV,
IEC 61000-4-2 ± 15 kV air
Electrical fast ± 2 kV for AC line;
transient/burst 100 kHz repetition
IEC 61000-4-4 frequency
Surge IEC 61000- ± 0,5 kV,
4-5 ± 1kV line-to-line;
± 0,5 kV, ± 1kV,
± 2kV line-to-ground
Voltage dips, short • 0% UT; 0,5 cycle At
interruptions and
voltage variations
on power
supply input lines • 0% UT; 1 cycle and
IEC 61000-4-11
• 0% UT; 250/300
Power frequency 30 A/m
(50/60Hz) 50 Hz or 60 Hz
magnetic field IEC
61000-4-8
Conducted RF IEC 3 V
61000-4-6 0,15 MHz – 80 MHz
80% AM at 1 kHz
6V in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80% AM at 1 kHz
Radiated RF IEC 10 V/m
61000-4-3 80 MHz – 2,7 GHz
80% AM at 1 kHz
9 – 28 V/m
At IEC 60601-1-2:
2014
Table 9 frequencies
NOTE 1 UT is the a.c. mains voltage prior to application of the test level.
NOTE 2 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 3 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people .
a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Ameda Platinum Breast Pump is used exceeds the applicable RF compliance level above, the Ameda Platinum Breast Pump should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Ameda Platinum Breast Pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
70% UT; 25/30
cycles Single phase:
at 0°
cycles
Compliance level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
± 2 kV for AC line;
100 kHz repetition
frequency
± 0,5 kV,
± 1kV line-to-line;
± 0,5 kV, ± 1kV,
± 2kV line-to-ground
• 0% UT; 0,5 cycle At
0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
• 0% UT; 1 cycle and
70% UT; 25 cycles
At 0°
• 0% UT; 250 cycles
30 A/m
50 Hz and 60 Hz
3 V
0,15 MHz – 80 MHz
80% AM at 1 kHz
6V in ISM and
amateur radio bands
between 0,15 MHz
and 80 MHz
80% AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
9 – 28 V/m
At IEC 60601-1-2:
2014
Table 9 frequencies
Electromagnetic environment – guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30% .
Mains power quality should be that of a
typical commercial or hospital environ-
ment .
Mains power quality should be that of a
typical commercial or hospital environ-
ment .
Mains power quality should be that of a
typical commercial or hospital environ-
ment. If the user of the Ameda Platinum
Breast Pump requires continued operation
during power mains interruptions, it is
recommended that the Ameda Platinum
Breast Pump be powered from an uninter-
ruptible power supply.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Portable and mobile RF communications
equipment should be used no closer to any
part of the Ameda Platinum Breast Pump.
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1,2√P
d = 1,2√P 80 MHz to 800 MHz
d = 2,3√P 800 MHz to 2,7 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m). Field strengths
from fixed RF transmitters, as determined
by an electromagnetic site survey,
be less than the compliance level in each
frequency range.
b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
a should
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