Users Manual Part 7

Immunity Test IEC 60601 Test Level
Compliance
Level
Electromagnetic Environment -
Guidance
27 V/m
380 MHz – 390 MHz
18 Hz PM carrier
28 V/m
430 MHz – 470 MHz
1 kHz FM carrier
9 V/m
704 MHz – 787 MHz
217 Hz PM carrier
27 V/m
380 MHz –
390 MHz
18 Hz PM
carrier
28 V/m
430 MHz –
470 MHz
1 kHz FM
carrier
10 V/m
704 MHz –
787 MHz
217 Hz PM
carrier
Mobile RF communications
equipment that transmit at
frequencies below 80 MHz (such as
radios in Police cars, Ambulances,
Fire trucks, and vehicle mounted
CB & HAM radios) should be kept
at least 4.5 m [14 ft 7 inches] away
from the Remunity
™
Pump for
Remodulin
®
(treprostinil) Injection.
Portable and mobile RF
communications equipment at
frequencies above 80 MHz (such as
Walkie-Talkies, hand held / vehicle
mounted HAM radios, radios in
Police cars, Ambulances, and Fire
trucks) should be kept at least 8.9
m [30 ft] away from the Remunity
™
Pump for Remodulin
®
(treprostinil)
Injection.
Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Appendix A
228 DKPI-09153-001-Rev. 1.4