Boston Scientific Vercise DBS Instrucciones De Uso página 80

Vercise™ DBS Programming Manual
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.
Vercise™ DBS Programming Manual
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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 to the public low
Not Applicable
voltage power supply network that supplies
buildings used for domestic purposes.
Not Applicable