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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
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
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
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.
