Savi Dual - Page 25

SAVI Dual™ Migraine Therapy Instructions for Use 25
EMC Guidance (continued)
Electromagnetic Immunity
The System is intended for use in the electromagnetic environment of typical homes.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment
– Guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000
-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.7 GHz
3 Vrms
6 V rms in ISM and
amateur radio bands
10 V/m
The System is suitable for the electromagnetic
environment of typical homes, commercial or
hospital settings.
The System was also tested for radiated immunity to RF wireless communication equipment at the test levels below.
Frequency (Hz)
Modulation
Level V/m
385
Pulse, 18 Hz, 50% DC
27
450
FM, 1 kHz Sine, ±5 Hz Deviation
28
710, 745, 780
Pulse, 217 Hz, 50% DC
9
810, 870, 930
Pulse, 18 Hz, 50% DC
28
1720, 1845, 1970
Pulse, 217 Hz, 50% DC
28
2450
28
5240, 5500, 5785
9
The device and the method of use that comprise the eNeura SAVI Dual

are protected by U.S. Patents 6,402,678,
7,294,101, 7,494,458 and 7,601,116; by European Patents 1 307 260 B1 and 1 977 787 B1; and by Canadian Patent
2423840. Additional patents are pending.