Thoratec HeartMate III, Instructions For Use Manual, Page: 417 / 458

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HeartMate III Left Ventricular Assist System Instructions for Use B-29
Field strengths from fixed RF transmitters, such as base stations for radios (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theoretically with accuracy.
The HeartMate III LVAS with 14V Li-Ion Batteries meets the electromagnetic radiated emissions
requirements of RTCA/DO-160G (also EUROCAE ED-14G), Sec. 21, for Category "M" location
devices.
The HeartMate III LVAS with 14V Li-Ion Batteries meets the radiated and conducted (due to RF)
electromagnetic immunity requirements of RTCA/DO-160G (also EUROCAE ED-14G), Sec. 20,
for Category "R" location devices.
To assess the electromagnetic environment (home, office, etc.) due to fixed RF transmitters, an
electromagnetic (EMC) “site survey” (measurement) should be considered. If the measured field
strength (in Volts per meter, V/m) in the location(s) in which the HeartMate III Left Ventricular
Assist System is used exceeds the applicable RF compliance level for the frequency bands above,
the HeartMate III LVAS should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the
HeartMate III LVAS.
These guidelines may not apply in all situations.
WARNING !
• Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 20 cm (8 inches) to any part of the
HeartMate III LVAS (powered by the 14V Li-Ion Batteries), including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.
• Use of accessories or cables other than those specified or provided by Thoratec Corp. could
result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
• Avoid use of HeartMate III LVAS (and its cables and parts) within 5 cm (2 inches) of a
microwave oven or its cord.
• Use of accessories or cables other than those specified or provided by Thoratec Corp. could
result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
• To help ensure good electromagnetic performance throughout the usable life of the
HeartMate III LVAS, be certain to follow the maintenance schedule and procedures as
described in Equipment Storage and Care.