Thoratec HeartMate III, Instructions For Use Manual, Page: 403 / 458

B
HeartMate III Left Ventricular Assist System Instructions for Use B-15
Conducted RF Immunity /
IEC 61000-4-6
EN 61000-4-6
3 Vrms
and
6 Vrms
(within ISM and amateur
bands)
150 kHz – 80 MHz
80% AM at 1 kHz
For many common 2-Watt (maximum)
transmitters and some ISM products and
their parts (cables, antennas, etc.)
operating in the 150 kHz to 80 MHz
range, the following minimum separation
distance to the HeartMate III LVAS with
Mobile Power Unit is recommended:
Outside ISM/Amateur bands -- 150 kHz -
80 MHz: 1.7 m (5.7 feet)
In ISM/Amateur bands -- 150 kHz - 80
MHz: 2.8 m (9.2 feet)
Equipment
[a]
examples include: CB Radios,
Amateur “HAM” radios, Diathermy medical
devices,
Note: 1,000 kHz = 1.0 MHz
Note: “ISM” = Industrial, Scientific and
Medical devices, as per the International
Technical Union
[a] – List is not comprehensive.
Power Frequency
Magnetic Field Immunity /
IEC 61000-4-8
EN 61000-4-8
30 A/m (50 or 60 Hz)
Power Frequency Magnetic Field should be
that of a typical commercial or hospital
environment where the HeartMate III LVAS
with Mobile Power Unit is used.
Voltage Dips, Short
Interruptions and Voltage
Variations on Power
Supply Input Lines
Immunity /
IEC 61000-4-11
EN 61000-4-11
0 % of U
T
; ½ cycle
0 % of U
T
; 1 cycle
and
70 % of U
T
; 25 or 30 cycles
(0.5 sec.)
0 % of U
T
; 250 or 300 cycles
(5 sec.)
Mains power quality should be that of a
typical commercial or hospital environment
where the HeartMate III LVAS with Mobile
Power Unit is used.
Note – U
T
: A.C. Mains voltage supply,
either 50 or 60 Hz (cycles per sec.)