Table 1. (Table 201) 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
RF Emissions CISPR 11
Group 1
Class A
Harmonics IEC 61000-3-2
Class A
Flicker IEC 61000-3-3
Complies
RTCA DO-16G Section 21.4,
Category M
conducted emissions
RTCA DO-16G Section 21.5,
Category B
radiated emissions
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in
a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
Table 2. (Table 202) 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
Electrostatic Discharge (ESD)
±8 kV contact
IEC 61000-4-2
±15 kV air
Electrical Fast Transient/burst
±2 kV Mains
IEC 61000-4-4
±1 kV for input/output lines
Surge
±1 kV Differential
IEC 61000-4-5
±2 kV Common
Voltage dips, short
> 95% dip for 0.5 cycle
interruptions and voltage
60% dip for 5 cycles
variations on power supply
30% dip for 25 cycles
input lines
> 95% dip for 5 seconds
IEC 61000-4-11
Power Frequency
30 A/m
50/60 Hz Magnetic Field
IEC 61000-4-8
Automated Impella Controller with SmartAssist
Electromagnetic Enforcement – Guidance
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.
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.
Compliance Level
±8 kV contact
±15 kV air
±2 kV Mains
±1 kV for input/output lines
±1 kV Differential
±2 kV Common
> 95% dip for 0.5 cycle
60% dip for 5 cycles
30% dip for 25 cycles
> 95% dip for 5 seconds
30 A/m
®
Electromagnetic Environment – Guidance
The relative humidity should be at least 5%.
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 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 magnetic fields should be that of a typical location in a
typical commercial or hospital environment.
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