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Table 2. Electromagnetic Emissions
Guidance and manufacturer's declaration – electromagnetic emissions
The Visual-ICE Cryoablation System is intended for use in a professional healthcare facility electromagnetic
environment with the compliance levels specified below� The customer or the user of the Visual-ICE Cryoablation
System should assure that it is used in such an environment�
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions, IEC 61000-3-2
Voltage fluctuations/ flicker emissions,
IEC 61000-3-3
NOTE: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A)� If it is used in a residential environment (for which CISPR 11 class B is normally required) this
equipment might not offer adequate protection to radio-frequency communication services� The user might need
to take mitigation measures, such as relocating or reorienting the equipment�
Compliance Electromagnetic environment – guidance
Group 1
The Visual-ICE Cryoablation System 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�
Class A
Class A
Complies
19
Black (K) ∆E ≤5.0
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