biodex BALANCE SYSTEM SD Operation & Service Manual page 95

CONTENTS
Declaration of Conformity
Emissions
manufacturer's declaration electromagnetic emissions
The Balance System SD is intended for use in the electromagnetic environment specified below. The
customer or the user of the Balance System SD should assure that it is used in such an environment.
Emission test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic distortion
EN 61000-3-2
Voltage fluctuations
and flickerEN 61000-3-3
Immunity
manufacturer's declaration electromagnetic immunity
The Balance System SD is intended for use in the electromagnetic environment specified below. The
customer or the user of the Balance System SD should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
Electrical fast
transients/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
APPENDIX E
Compliance
Group 1
Class A
Class A
Complies
IEC 60601-1-2
Test level
± 6 kV contact
± 2 kV for power lines
± 1 kV for
input/output lines
± 1 kV differential mode
± 2 kV common mode
— E-2 —
Electromagnetic environment
The Balance System SD 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
The Balance System SD 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 for domestic purposes.
IEC 60601-1-2 Electromagnetic
Compliance level environment – guidance
Contact ± 6 kV Floor should be wood,
concrete or ceramic tiles.
If floor is covered with
synthetic material, the
relative humidity should
be at least 30%
Power ± 2 kV Mains power quality
Signal ± 1 kV should be that of a
typical commercial or
hospital environment
± 1 kV diff. mode Mains power quality
± 2 kV com. mode should be that of a
typical commercial or
hospital environment