Boston Scientific AngioJet Ultra 5000A Console Manual Del Usuario página 12

Table 2� Guidance and manufacturer's declaration - electromagnetic immunity
The AngioJet™ System is intended for use in the electromagnetic environment specified below. The customer or the user of the AngioJet System should assure that it is used
in such an environment.
Immunity Test
Electrostatic Discharge (ESD)
IEC 61000-4-2
Electrical fast transient / burst
IEC 61000-4-4
Surge: Line-to-line
IEC 61000-4-5
Surge: Line-to-ground
IEC 61000-4-5
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
Conducted disturbances induced
by RF fields
IEC 61000-4-6
Radiated RF EM fields
IEC 61000-4-3
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3
NOTE 1: U is the a.c. mains voltage prior to application of the test level.
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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.
NOTE 4: The AngioJet System is intended for use in hospitals and outpatient facilities only. The equipment has not been assessed for use near high frequency surgical
equipment and interference may occur. If degradation of performance is observed, move the equipment away from the high frequency surgical equipment or contact
Boston Scientific for assistance. For additional corrective actions, refer to "Maintenance, Troubleshooting and Service" Section.
a Field strengths 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 AngioJet System is used exceeds the applicable RF compliance level above, the AngioJet
System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
AngioJet System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
Black (K) ∆E ≤5.0
IEC 60601 Test Level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
± 2 kV input AC power
± 1 kV SIP/SOP
100 kHz repetition frequency
± 0.5 kV, ± 1 kV input AC power
± 0.5 kV, ± 1 kV, ± 2 kV input AC power
0% U for 0.5 cycle
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At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% U for 1 cycle
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and
70% U for 25/30 cycles
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Single phase: at 0°
0% U for 250/300 cycles
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30 A/m
50 Hz or 60 Hz
3 V between 0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and
80 MHz
At 80% AM with 1 kHz modulation
frequency
3 V/m between 80 MHz – 2.7 GHz
At 80% AM with 1 kHz modulation frequency
380 MHz - 390 MHz: 27 V/m
430 MHz - 470 MHz: 28 V/m
704 MHz - 787 MHz: 9 V/m
800 MHz - 960 MHz: 28 V/m
1700 MHz - 1990 MHz: 28 V/m
2400 MHz - 2570 MHz: 28 V/m
5100 MHz - 5800 MHz: 9 V/m
Compliance Level
± 2 kV, ± 4 kV, ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
± 2 kV input AC power
± 1 kV SIP/SOP
100 kHz repetition frequency
± 0.5 kV, ± 1 kV input AC power
± 0.5 kV, ± 1 kV, ± 2 kV input AC power
0% U for 0.5 cycle
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At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0% U for 1 cycle
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and
70% U for 25 cycles (50 Hz) and
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30 cycles (60 Hz)
Single phase: at 0°
0% U for 250 cycles (50 Hz)
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and 300 cycles (60 Hz)
30 A/m
50 Hz and 60 Hz
3 V between 0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz
and 80 MHz
At 80% AM with 1 kHz modulation
frequency
3 V/m between 80 MHz – 2.7 GHz
At 80% AM with 1 kHz modulation
frequency
385 MHz: 27 V/m
450 MHz: 28 V/m
710 MHz: 9 V/m
745 MHz: 9 V/m
780 MHz: 9 V/m
810 MHz: 28 V/m
870 MHz: 28 V/m
930 MHz: 28 V/m
1720 MHz: 28 V/m
1845 MHz: 28 V/m
1970 MHz: 28 V/m
2450 MHz: 28 V/m
5240 MHz: 9 V/m
5500 MHz: 9 V/m
5785 MHz: 9 V/m
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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
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Console
requires continued operation during
power mains interruptions, it is
recommended that the Console be
powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Field strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey , should be less than the
a
compliance level in each
frequency range .
b
Interference may occur in the vicinity
of equipment marked with the following
symbol: