Fresenius Kabi Agilia SP, Technical Manual

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141
23.4.2
Table 2 - Guidance and Manufacturer's Declaration -
Electromagnetic Immunity
Warning

Agilia pump and its accessories are intended to be used in the
electromagnetic environments specified below.

The customer or the user of Agilia pump should ensure that it is
used in such environments.
Immunity Test
IEC 60601-1-2
- - - - - - - - - - - - - -
Compliance
Level
Obtained by
the Device
Electromagnetic Environment -
Guidance
IEC 60601-2-24
and ANSI/AAMI
ID26
Test Level
Electrostatic
Discharge (ESD)
IEC 61000-4-2 ± 6 kV contact
± 8 kV air
- - - - - - - - - - - - - -
± 8 kV contact
± 15 kV air
Floor coverings made from wood, tiles and
concrete, with relative humidity level at
least 30 %, make it possible to guarantee
the necessary level of conformity. If it is not
possible to guarantee this environment,
additional precautions must be taken, such
as: use of anti-static equipment,
preliminary user discharge and the
wearing of antistatic clothing.
± 8 kV contact
± 15 kV air
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
AC power quality should be that of a
typical commercial or healthcare facility
environment.
Surge
IEC 61000-4-5
± 1 kV
differential mode
± 2 kV
common mode
± 1 kV
differential mode
± 2 kV
common mode
AC power quality should be that of a
typical commercial or healthcare facility
environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
< 5% Ut
(> 95% dip in Ut)
for 0.5 cycles
< 5% Ut
(> 95% dip in Ut)
for 0.5 cycles
AC power quality should be that of a
typical commercial or healthcare facility
environment.
For short and long interruptions (< than
battery life) of AC power, the internal
battery provides continuity of service.
40% Ut
(60% dip in Ut)
for 5 cycles
40% Ut
(60% dip in Ut)
for 5 cycles
70% Ut
(30% dip in Ut)
for 25 cycles
70% Ut
(30% dip in Ut)
for 25 cycles
< 5% Ut
(> 95% dip in Ut)
for 5 s
< 5% Ut
(> 95% dip in Ut)
for 5 s