Federal Communications Commission Notice; Electromagnetic Compatibility - Abiomed Automated Impella Controller Manual De Usuario

EQUIPMENT CLASSIFICATIONS
Type of protection against IEC 60601-1: Class I degree of protection: CF
electric shock defibrillation-proof and internally powered. Relies
not only on basic insulation against shock but also
includes additional protection. Accomplished by
providing means for connecting the equipment to
the protective earth conductor of the fixed wiring
of the installation in a way that prevents accessible
metal parts from becoming live if basic insulation
fails.
Degree of protection Class I Equipment
against electric shock
for Automated Impella
Controller
Mode of operation Continuous
Degree of protection Not suitable for use in the presence of a
against explosion hazard flammable anesthetic mixture with air or with
oxygen or nitrous oxide. Also not suitable for use
in an oxygen-enriched atmosphere.
Degree of protection IEC 60529: IPX1 protected against dripping
against harmful ingress water.
of water
EQUIPMENT DESIGN
The Automated Impella Controller conforms to the applicable requirements
of the following standards:
• IEC 60601-1: 2012 Edition 3.1 Medical Electrical Equipment Part 1:
General Requirements for Basic Safety and Essential Performance
• CSA C22.2#60601-1 (2014) Ed:3 Medical Electrical Equipment Part 1:
General Requirements for Basic Safety and Essential Performance
• AAMI ES60601-1:2005 +C1:A2 Medical Electrical Equipment Part 1:
General Requirements for Basic Safety and Essential Performance
• IEC 60601-1-2:2014 Edition 4, Medical Electrical Equipment – Part
1-2: General Requirements for Basic Safety and Essential Performance
– Collateral Standard: Electromagnetic Disturbances – Requirements
and Tests
• IEC 60601-1-6:2010, AMD1:2013 Medical Electrical Equipment – Part
1-6: General Requirements for Safety – Collateral Standard: Usability
• IEC 60601-1-8:2006, AM1:2012 Medical Electrical Equipment – Part
1-8: General Requirements for Safety – Collateral Standard: General
Requirements, Tests and Guidance for Alarm Systems in Medical
Electrical Equipment and Medical Electrical Systems
• IEC 62304:2015 Medical Device Software - Software Life-cycle
Processes
• RTCA DO160G Environmental Conditions and Test Procedures for
Airborn Equipment
• AIM 7351731 Medical Electrical Equipment and System
Electromagnetic Immunity Test for Exposure to Radio Frequency
Identification Readers
Complete list of standards available on request.
20

FEDERAL COMMUNICATIONS COMMISSION NOTICE

This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including
interference that may cause undesired operation.
Changes or modifications not expressly approved by Abiomed, Inc. could
void the user's authority to operate this device.

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.
The Automated Impella Controller (AIC) performs as intended when
exposed to radiofrequency (RF) disturbances below 20 V/m. During
transport, the AIC may be exposed to RF disturbances above 20 V/m,
which could cause minor problems, such as intermittent displays of
soft button menu selections, which have no effect on the operating
parameters of the Impella support system, and will resolve readily
once the disturbance ends. It could also potentially result in loss
of support. Patients must be closely monitored at all times during
transport.
Do not transport an Impella patient via commercial aircraft. Loss of
support may occur aboard a commercial aircraft due to exposure to
radiofrequency (RF) disturbances above the compliance level (<20
V/m) of the Automated Impella Controller.
NOTE: The EMC tables and other guidelines 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. For the electromagnetic testing (detailed in the following
tables), the AIC Essential Performance was specified as: during the entire
testing period, the AIC continues to provide support to the patient.
User Manual