Users Manual Part 7

Appendix A
Immunity Test IEC 60601 Test Level
Compliance
Level
Electromagnetic Environment -
Guidance
Radiated RF IEC
61000-4-3
10 V/m
80 MHz to 2.7 GHz
1 kHz 80% AM carrier
20 V/m
1 MHz to 80
MHz
200 Hz 80%
AM carrier
10 V/m
80 MHz to 2.7
GHz
1 kHz 80%
AM carrier
Use in professional healthcare
facility and home healthcare
environments, excluding near high
frequency surgical equipment or
near MR machines.
Portable communications
equipment that transmit at
frequencies below 80 MHz (such as
Walkie-Talkies and hand held HAM
radios) should be kept at least 1.0
m [3 ft 3 inches] away from the
Remunity
™
Pump for Remodulin
®
(treprostinil) Injection.
Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
DKPI-09153-001-Rev. 1.4 227