biodex BioSway - Declaration of Conformity

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CONTENTS
APPENDIX E — E-2 —
Emissions
Manufacturer’s declaration electromagnetic emissions
The BioSway Balance is intended for use in the electromagnetic environment specified below. The customer or the user of
the BioSway Balance system should assure that it is used in such an environment
Emission test
Compliance
Electromagnetic environment
RF emissions
CISPR 11
Group 1
The BioSway Balance system generates RF energy only for its internal
functions. Therefore, its RF emission is very low and is not likely to
cause any interference in nearby electronic equipment
RF emissions
CISPR 11
Class A
Harmonic distortion
E
N 61000
-3-2
Class A
Voltage fluctuations
and flicker
EN 61000-3-3
Complies
The BioSway Balance system is suitable for use in all
establishments other than domestic and those directly connected to the
public low-voltage power supply network supplying buildings used
f
or domestic pur
p
oses.
Immunity
Manufacturer’s declaration electromagnetic immunity
The BioSway Balance is intended for use in the electromagnetic environment specified below. The customer or the user of
the BioSway Balance system should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
Test level
IEC 60601-1-2
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
Contact ± 6 kV
Air ± 8 kV *
Floor should be wood, concrete or ceramic
tiles. If floor is covered with synthetic
material, the relative humidity should be at
least 30%
Electrical fast
transients/burst
IEC 61000-4-4
± 2 kV for power lines
± 1 kV for input/output
lines
Power ± 2 kV
Signal ± 1 kV
Mains power quality should be that of a
typical commercial or hospital environment
Surge
IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
± 1 kV diff. mode
± 2 kV com. mode
Mains power quality should be that of a
typical commercial or hospital environment
* Reference test results for details
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