Abiomed Impella Manuel D'utilisation page 18

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
RF Emissions CISPR 11
Harmonics IEC 61000-3-2
Flicker IEC 61000-3-3
RTCA DO-16G Section 21.4,
conducted emissions
RTCA DO-16G Section 21.5,
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
Electrostatic Discharge (ESD)
IEC 61000-4-2
Electrical Fast Transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Power Frequency
50/60 Hz Magnetic Field
IEC 61000-4-8
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Compliance Electromagnetic Enforcement – Guidance
Group 1 The Automated Impella Controller uses RF energy only for its internal function. Therefore, its RF emissions are
Class A very low and are not likely to cause any interference in nearby electronic equipment.
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.
Complies
Category M
Category B
IEC 60601 Test Level Compliance Level
±8 kV contact ±8 kV contact
±15 kV air ±15 kV air
±2 kV Mains ±2 kV Mains
±1 kV for input/output lines ±1 kV for input/output lines
±1 kV Differential ±1 kV Differential
±2 kV Common ±2 kV Common
> 95% dip for 0.5 cycle > 95% dip for 0.5 cycle
60% dip for 5 cycles 60% dip for 5 cycles
30% dip for 25 cycles 30% dip for 25 cycles
> 95% dip for 5 seconds > 95% dip for 5 seconds
30 A/m 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.
User Manual