32
Regulatory Information
Regulatory Information
33
Medical Equipment Standards
Table 5.
IEC 60601-1-2 Performance Criteria –
Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The Hub is intended for use in the electromagnetic environment specified below. The customer or the user of the Hub should ensure that it
is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The Hub must emit electromagnetic energy in order to perform its intended function
as a communication device. Nearby electronic equipment may be affected.
The Hub is not a Group 2 device as RF energy is not used as a form of patient
treatment.
RF emissions,
CISPR 11
Class B
The Hub is suitable for use in domestic establishments and those directly connected
to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions,
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions/
IEC 61000-3-3
Complies
