Users Manual Part 7

Immunity Test IEC 60601 Test Level
Compliance
Level
Electromagnetic Environment -
Guidance
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-
11
0% U
T
for 0.5 cycle at 0°, 45°,
90°, 135°, 180°, 225°, 270° and
315° phase angles
0% U
T
for 1 cycle
70% U
T
for 25 cycles at 50 Hz,
30 cycles at 60 Hz
0% U
T
for 250 cycles at 50 Hz,
300 cycles at 60 Hz
0% U
T
for 0.5
cycle at 0°,
45°, 90°,
135°, 180°,
225°, 270°
and 315°
phase angles
0% U
T
for 1
cycle
70% U
T
for
25 cycles at
50 Hz, 30
cycles at 60
Hz
Mains power quality should be that
of a typical professional healthcare
facility and home healthcare
environments.
If the user of the Remunity
™
Pump
for Remodulin
®
(treprostinil)
Injection requires continued battery
charging during power mains
interruptions, it is recommended
that the Remunity
™
Pump for
Remodulin
®
(treprostinil) Injection
be powered from an uninterruptible
power supply or a battery.
Table 30: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Appendix A
232 DKPI-09153-001-Rev. 1.4