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Appendix
User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference I
1
User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference
:
apply to all the equipments and systems
2
WIT-601A Infusion Pump is intended to be used in the following specified electromagnetic environments.
Buyers or users should ensure that the pump is used in such environments.
3
Emission test
Compliance
Guide to electromagnetic environment
4
RF emission CLSPR 11
Group 1
WIT-601A Infusion Pump’s RF energy only acts in the
device. As a result, the RF emission is very low and would
not interfere with nearby electronic equipment.
5
RF emission CLSPR 11
Class B
6
IEC
61000-3-2
harmonic current
Class A
7
IEC 61000-3-3 voltage
fluctuation and flicker
Complies
User's Guide and Manufacturer’s Statement of Anti-electromagnetic Interference
:
apply to all the
equipments and systems
WIT-601A Infusion Pump is intended to be used in the following specified electromagnetic environments.
Buyers or users should ensure that the pump is used in such environments.
Immunity test
IEC 60601
Test level
Compliance
Guide to electromagnetic
environment
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact-type
± 8 kV air-type
± 6 kV contact-type
± 8 kV air-type
Wooden, concrete or ceramic tile
flooring preferred. If composite
material flooring is used, the
relative humidity should not be
less than 30%.
Electrical
fast
transient/burst
IEC61000-4-4
± 2kV power cord
± 1kV input/output
± 2kV power cord
± 1kV input/output
Network power quality should be
qualified for typical hospital or
commercial environments.
Surge
IEC 61000-4-5
± 1kV differential
mode
± 2kV common mode
± 1kV differential
mode
± 2kV common
mode
Network power quality should be
qualified for typical hospital or
commercial environments.