Flowonix Prometra Patient Therapy Controller, Manual

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Patient Therapy Controller (PTC ® ) Guide, For use with Prometra ® Programmable Infusion Systems
25
Appendix
Technical Specifications and EMC Tables (continued)
Table 2: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Patient Therapy Controller is intended for use in the electromagnetic environment specified
below. The customer and/or the user of this device should assure that it is operated in such an
environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level Electromagnetic Environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2 ± 8 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air ± 6 kV contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV air The home healthcare environment
can be assumed to be uncontrolled
with respect to relative humidity and
the use of anti-static (or low static)
flooring and material. The relative
humidity can be quite low in some
locations, as low as 5 %
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be that
of a typical home healthcare
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth Mains power quality should be that
of a typical home healthcare
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11 0 % UT for 0.5
cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % UT for 1 cycle
and
70 % UT for 25/30
cycles
Single phase: at 0°
0 % UT; 250/300
cycle
0 % UT for 0.5
cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % UT for 1 cycle
and
70 % UT for 25/30
cycles
Single phase: at
0°
0 % UT; 250/300
cycle Mains power quality should be that
of a typical commercial or hospital
environment. If the user of this
equipment requires continued
operation during power mains
interruptions, it is recommended that
this equipment be powered from an
uninterruptible power supply or
a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.