Electromagnetic Compatibility - Boston Scientific Vercise Gevia Instrucciones De Uso

Electromagnetic Compatibility

BS EN 60601-1-2 Classification Information
Testing to demonstrate compliance of the Vercise Gevia DBS System with the essential
requirements and other relevant provisions of Directive 1999/5/EC were leveraged from testing
performed on the Precision™ Montage SCS System.
• Internally powered
• Continuous operation
• Ordinary equipment
• Class II
Guidance and manufacturer's declaration – electromagnetic emissions
The Vercise Gevia System is intended for use in electromagnetic environment specified below.
The customer or the user of the Vercise Gevia 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
Compliance Electromagnetic environment –
guidance
Group 1 The Vercise Gevia 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 Gevia System is suitable for
use in all establishments, including domestic
establishments and those directly connected
Class B
to the public low voltage power supply
network that supplies buildings used for
Complies
domestic purposes.
Electromagnetic Compatibility
Vercise Gevia™ Information for Prescribers
91168753-02 Rev A 11 of 505