Chison ECO 6 - Appendix C: Guidance and Manufacturers Declaration

ECO 6 Digital Color Doppler Ultrasound System
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Appendix C: Guidance and Manufacturer’s Declaration
1. Guidance and manufacturer’s declaration – electromagnetic emissions
The ECO 6 is intended for use in the electromagnetic environment specified below. The customer or
the user of the ECO 6 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The ECO 6 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
CISPR 11
Class A
The ECO 6 is suitable for use in
medical establishments including
domestic establishments and those
directly connected to the public
high-voltage power supply network
that used for non-domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
2. Guidance and manufacturer’s declaration – electromagnetic immunity
The ECO 6 is intended for use in the electromagnetic environment the ECO 6 should assure that it is
used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment –
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power
supply lines
±1 kV for input/output
lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
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