Table 16. Guidance and Manufacturer's Declaration —Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the
user of the system should ensure that it is used in such an environment.
Immunity Tests
Conducted
3 Vrms at 0.15 MHz–80
RF: conducted
MHz AC/DC/Signal lines
immunity on all
6 Vrms at ISM bands
ports
between 0.15 MHz–80
IEC 61000‑4‑6
MHz
Conducted
RF: conducted
3 Vrms at 0.15 MHz–80
immunity on
MHz and 480.0498 kHz
patient coupling
6 Vrms at ISM Band, 3
ports
sec dwell time
IEC 61000‑4‑6
IEC 60601 Test Level
Compliance
Electromagnetic Environment –
Level
Portable and mobile RF
communications equipment should
be used no closer to any part of the
system, including cables, than the
recommended separation distance
calculated from the equation
In compliance
applicable to the frequency of the
transmitter.
Recommended separation
distance d (m)
d=1.2 √P
Guidance
271
0900‑4788 REV‑10