Thoratec HeartMate III, Instructions For Use Manual, Page: 400 / 458

B
B-12 HeartMate III Left Ventricular Assist System Instructions for Use
Testing and Classification: Mobile Power Unit
Declaration and Guidance for Electromagnetic Disturbances for the
Mobile Power Unit
The HeartMate III LVAS (powered by the Mobile Power Unit) is suitable for use in the following
environments:
• Hospitals, including ORs and emergency rooms
• Treatment areas near active HF Surgical equipment.
• Homes, workplaces and retail places.
• Public or private passenger watercraft/boats, ferries, etc.
Table B.3 Declaration and Guidance Concerning Electromagnetic Disturbances for Mobile Power Unit
HeartMate III LVAS Powered By the Mobile Power Unit
EM Disturbance type /
Standards
IEC 60601-1-2 (2014)
Compliance Level
Use Environment Guidance
RF Emissions /
CISPR 11
EN 55011 Group 1, Class B
30 – 1,000 MHz
The HeartMate III LVAS with Mobile Power
Unit is suitable for use in all establishments,
including domestic establishments and
those directly connected to the public
low-voltage power supply (mains) network
that supplies domestic (residential)
buildings.
The HeartMate III LVAS with Mobile Power
Unit uses RF energy only for its internal
purposes and thus has low unintentional RF
emissions and is unlikely to cause
interference in nearby electronic equipment.
Harmonic Emissions /
IEC 61000-3-2
EN 61000-3-2
Class A
Voltage Fluctuations &
Flicker Emissions /
IEC 61000-3-3
EN 61000-3-3
Complies fully
Electrostatic Discharge
(ESD) Immunity /
IEC 61000-4-2
EN 61000-4-2
±8 kV Contact
±15 kV Air
The relative humidity where the HeartMate
III LVAS with Mobile Power Unit is used
should be at least 5%. Higher relative
humidity will reduce the severity of ESD
events.