Thoratec HeartMate III, Instructions For Use Manual, Page: 409 / 458

B
HeartMate III Left Ventricular Assist System Instructions for Use B-21
Portable RF
Communication Equipment
Immunity /
IEC 61000-4-3
EN 61000-4-3
380 - 390 MHz, 27 V/m
[1]
;
430 - 470 MHz, 28 V/m
[3]
;
704 - 787 MHz, 9 V/m
[2]
;
800 - 960 MHz, 28 V/m
[1]
;
1.7 - 1.99 GHz, 28 V/m
[2]
;
2.4 - 2.57 GHz, 28 V/m
[2]
;
and
5.1 - 5.8 GHz, 9 V/m
[2]
------------------------------
[1] 18 Hz Pulse Modulation
[2] 217 Hz Pulse Modulation
[3] FM at +/- 5 kHz Deviation
Portable RF Communication Equipment
(up to 2-Watt max. of transmit power) and
its parts (cables, antennas, etc.) operating
in the frequencies shown here should not
be closer to the HeartMate Battery
Charger, and its parts, than 0.3 m (12
inches).
Equipment
[a]
examples: TETRA 400,
GMRS, LTE Bands, GSM and CDMA
Phones, UMTS, Bluetooth, WLAN, Wi-Fi,
and RFID systems.
Note: 1,000 MHz = 1.0 GHz
[a] – List is not comprehensive.
Electrical Fast Transient &
Burst Immunity /
IEC 61000-4-4
EN 61000-4-4
± 2 kV for power supply lines
100 kHz repetition rate
Mains power quality should be that of a
typical commercial or hospital
environment where the HeartMate Battery
Charger is used.
Surge Immunity /
IEC 61000-4-5
EN 61000-4-5
± 0.5, ± 1 kV line to line
and
± 0.5, ± 1 kV, and ± 2 kV line
to earth