biodex 950-440 - Declaration of Conformity

116 Biodex Medical Systems, Inc. © 2017
Table 13.3. Emission Test Table
Table 13.4. Immunity Test Tables
Declaration of Conformity
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
Compliance
Electromagnetic environment
RF
emissions
CISPR 11
Group 1
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
RF
emissions
CISPR 11
Class A
The Balance System SD is suitable for use in all establishments
including domestic establishments and those directly connected
to the public low voltage power supply network supplying
buildings used for domestic purposes.
Harmonic
distortion EN
61000-3-2
Class A
Voltage
fluctuations and
flicker EN
61000-3-3
Complies
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
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
Contact ± 6
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.