8.6
ELECTROMAGNETIC COMPATIBILITY
Medical electrical equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the electromagnetic compatibility
(EMC) information provided in this document.
Portable and mobile RF communications equipment can affect medical electrical
equipment.
The equipment or system should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the equipment or system should
be observed to verify normal operation in the configuration in which it will be used.
Use of cables, other than those sold by Abiomed, may result in increased emissions
or decreased immunity of the Automated Impella® Controller.
The Automated Impella® Controller uses RFID (radio frequency identification) to
identify and communicate with the purge cassette. Other equipment may interfere
with the Automated Impella® Controller even if that other equipment complies with
CISPR emission requirements.
During transport, the Automated Impella® Controller may be exposed to stronger
electromagnetic disturbance than during in-hospital use. Strong electromagnetic
disturbance may cause the Automated Impella® Controller to display soft button
menu selections that were not selected by the user. Operators should be aware
that, under these conditions, the operating parameters are not affected. No
user intervention is required. Monitor Impella® RP Catheter flow and patient
hemodynamics to confirm normal operation. The condition will resolve itself once
the Automated Impella® Controller is no longer exposed to the disturbance.
NOTE
: The EMC tables and other guidelines that are included in this manual provide
information to the customer or user that is essential in determining the suitability of the
equipment or system for the electromagnetic environment of use, and in managing the
electromagnetic environment of use permit the equipment or system to perform to its intended
use without disturbing other equipment and systems or non-medical electrical equipment.
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
CI SP R 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
Instructions for Use & Clinical Reference Manual (US)
Compliance Electromagnetic Enforcement – Guidance
Group 1
Class A
Class A
Complies
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.
