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
8-6
Dialog
+
SW 9.xx
Electromagnetic Immunity, Table 204
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
electromagnetic 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
Portable and mobile RF communications equipment should be used no closer to any part of the Dialog
+
machine,
including cables, than the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
1.2
Recommended separation distance:
Conducted RF
acc. to IEC 61000-4-6
3 V
eff
150 kHz to 80 MHz
3 V
eff
P
d
2
.
1
=
Radiated RF
acc. to IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
80 MHz to 2.5 GHz
3 V/m
P
d
2
.
1
=
for 80 MHz to 800 MHz
Note:
The recommended distances are specified in the operating
instructions (for software
≥
9.xx), chapter 15.
P
d
33
.
2
=
for 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than
the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot
be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Dialog
+
machine is used exceeds the applicable RF compliance level above, the Dialog
+
machine should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Dialog
+
machine.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
