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SW9xx_sm_Chapter 8_1-2010.doc/pdf <100329> yymmdd
B. Braun Avitum AG
8-4
Dialog
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SW 9.xx
8.1.2
Electromagnetic Compatibility EMC
EMC
Electromagnetic compatibility EMC means that medical electrical equipment has the capability to work
satisfactory in an electromagnetic environment, without causing electromagnetic emissions, which would be
unacceptable for all other medical electrical equipment in this environment.
The following tables 201, 202 and 204 are guidelines from the IEC 60601-1-2 and must be observed.
Electromagnetic Emissions, Table 201
Guidance and manufacturer’s declaration – electromagnetic emissions
The Dialog
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machine is intended for use in the electromagnetic environment specified below. The customer or the user of the Dialog
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machine should assure that it is used in such an
environment.
Emissions test
Emissions test
Emissions test
Emissions test
Compliance
Compliance
Compliance
Compliance
Electromagnetic environment – guidance
Electromagnetic environment – guidance
Electromagnetic environment – guidance
Electromagnetic environment – guidance
RF emissions acc. to CISPR 11
Group 1
The Dialog
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machine uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions acc. to CISPR 11
Class B
The Dialog
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machine is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions acc. to IEC
61000-3-2
Class A
The Dialog
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machine is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/flicker
emissions acc. to IEC 61000-3-11
and DIN EN 60601-1-2:1993
Complies
The Dialog
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machine is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
If the network impedance of the supply network has a max. impedance of Z = (0.250 + j 0.150)
Ω
or the machine is
connected to a public low-voltage power supply network with a rated power supply of 230 V, measured between life L and
neutral N, connected to a one or three phase public power supply with a constant current load of the power supply
≥
100
A per phase, then it is also valid for the Dialog
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machine with the switch mode power supply microcontroller SMPS-MC.
