8 . A p p e n d i x
1 / 2 0 1 0
BA-TE-DE08C M.KAY
-
SW9xx_sm_Chapter 8_1-2010.doc/pdf <100329> yymmdd
B. Braun Avitum AG
8-5
Dialog
+
SW 9.xx
Electromagnetic Immunity, Table 202
Guidance and manufacturer’s declaration – electromagnetic immunity
The Dialog
+
machine is intended for use in the electromagnetic environment specified below. The customer or the user of the Dialog
+
machine should assure that it is used in such an
environment.
Immunity test
Immunity test
Immunity test
Immunity test
IEC 60601 test level
IEC 60601 test level
IEC 60601 test level
IEC 60601 test level
Compliance level
Compliance level
Compliance level
Compliance level
Electromagnetic environment – guidance
Electromagnetic environment – guidance
Electromagnetic environment – guidance
Electromagnetic environment – guidance
Electrostatic discharge (ESD) acc.
to IEC 61000-4-2
±
6 kV contact
±
8 kV air
±
6 kV contact
±
8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical fast transient/burst acc.
to IEC 61000-4-4
±
2 kV for power supply
lines
±
1 kV for input/output for
lines
±
2 kV for power supply
lines
±
1 kV for input/output for
lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge acc. to IEC 61000-4-5
±
1 kV line(s) to line(s)
±
2 kV line(s) to earth
±
1 kV differential mode
±
2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines acc. to IEC
61000-4-11
< 5 % U
T
(> 95 % dip in U
T
)
for 0.5 cycle)
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30% dip in U
T
)
for 25 cycles
< 5 % U
T
(>95 % dip in U
T
)
for 5 s
< 5 % U
T
(> 95 % dip in U
T
)
for 0.5 cycle)
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
< 5 % U
T
(>95 % dip in U
T
)
for 5 s
Mains power quality should be that of a typical commercial or hospital environment. If the user of
the Dialog
+
machine requires continued operation during power mains interruptions, it is
recommended that the Dialog
+
machine be powered from an uninterruptible power supply or a
battery.
Power frequency (50/60 Hz)
magnetic field acc. to IEC 61000-
4-8
3 A/m
3 A/m
The power frequency magnetic field should be measured in the intended installation location to
assure that it is sufficiently low.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
