Equipment Classifications; Federal Communications Commission Notice; Electromagnetic Compatibility - Abiomed Impella Manuel D'utilisation

EQUIPMENT CLASSIFICATIONS

Type of protection against
electric shock
Degree of protection against
electric shock for Automated
Impella Controller
Mode of operation
Degree of protection against
explosion hazard
Degree of protection against
harmful ingress 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 upon request.
Automated Impella Controller
IEC 60601-1: Class I degree of protection:
CF 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.
Class I Equipment
Continuous
Not suitable for use in the presence of a
flammable anesthetic mixture with air or
with oxygen or nitrous oxide. Also not
suitable for use in an oxygen-enriched
atmosphere.
IEC 60529: IPX1 protected against
dripping water.

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.
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