Abiomed Impella 2.5, Инструкция по эксплуатации

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9.9 Impella
®
System for Use During Cardiogenic Shock
Table 9.6 Guidance and manufacturer’s declaration - emissions, all equipment and systems
The Automated Impella
®
Controller is intended for use in the electromagnetic environment specified
below. The customer or user of the Automated Impella ® Controller should ensure that it is used in
such an environment.
Emissions Test Compliance Electromagnetic Enforcement – Guidance
RF Emissions
CISPR 11 Group 1
Class A The Automated Impella ® Controller uses RF energy only for
its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
Harmonics
IEC 61000-3-2 Class A
The Automated Impella
®
Controller is suitable for use in
all establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Flicker
IEC 61000-3-3 Complies
Table 9.7 Guidance and manufacturer’s declaration - immunity
The Automated Impella ® Controller is intended for use in the electromagnetic environment specified
below. The customer or user of the Automated Impella
®
Controller should ensure that it is used in
such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment –
Guidance
Electrostatic
Discharge (ESD) IEC
61000-4-2
±6 kV contact
±8 kV air ±8 kV contact
±15 kV air The relative humidity should be
at least 5%.
Electrical Fast
Transient/burst
IEC 61000-4-4
±2 kV Mains
±1
kV for input/
output lines
±2 kV Mains
±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 Differential
±2 kV Common ±1 kV Differential
±2 kV Common Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
> 95% dip for 0.5
cycle
60% dip for 5 cycles
30% dip for 25
cycles
> 95% dip for 5
seconds
> 95% dip for 0.5
cycle
60% dip for 5 cycles
30% dip for 25
cycles
> 95% dip for 5
seconds
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the Automated
Impella ® Controller requires
continued operation during
power mains interruptions,
it is recommended that
the Automated Impella ®
Controller be powered from an
uninterruptible power supply or
battery.
Power Frequency
50/60 Hz Magnetic
Field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be that of a
typical location in a typical
commercial or hospital
environment.
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