Boston Scientific Vercise DBS Mode D'emploi page 75

BS EN 60601-1-2 Classification Information
Testing to demonstrate compliance of the Vercise™ System with the essential
requirements and other relevant provisions of Directive 1999/5/EC were leveraged
from testing performed on the Precision™ SCS System.
• Internally powered
• Continuous operation
• Ordinary equipment
• Class II
Table 1: Guidance and manufacturer's declaration – electromagnetic emissions
The Vercise System is intended for use in electromagnetic environment specified
below. The customer or the user of the Vercise 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
Hereby, Boston Scientific declares that the Vercise System is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC.
Compliance Electromagnetic environment – guidance
Group 1 The Vercise 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 B The Vercise System is suitable for use in
all establishments, including domestic
establishments and those directly connected
Not
to the public low voltage power supply
Applicable
network that supplies buildings used for
Not
domestic purposes.
Applicable
Technical Support
Physician Manual
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