Electromagnetic Compatibility; En 60601-1-2 Classification Information - Boston Scientific Vercise Mode D'emploi

Electromagnetic Compatibility

EN 60601‑1‑2 Classification Information
• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
Table 1: Guidance and Manufacturer's Declaration
Electromagnetic Emissions
The Boston Scientific DBS System is intended for use in electromagnetic environment specified below.
The customer or the user of the Boston Scientific DBS System should ensure 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
Compliance
Group 1
Class B
Class B
Complies
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Electromagnetic Compatibility
Electromagnetic Environment
– Guidance
The Boston Scientific DBS 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.
The Boston Scientific DBS System is
suitable for use in all establishments,
including domestic establishments
and those directly connected to the
public low voltage power supply
network that supplies buildings used
for domestic purposes.
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