Boston Scientific Precision Novi Manual Del Usuario página 18

Information for Patients
EN 60601-1-2 Classification Information
• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
Table 1 – Guidance and Manufacturer's Declaration – electromagnetic emissions – for all ME Equipment and
ME Systems
Guidance and Manufacturer's Declaration - electromagnetic emissions
The Precision Novi System intended for use in the electromagnetic environment specified below.
The customer or user of the Precision Novi 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 Precision Novi System is in compliance with the essential requirements and other relevant
provisions of Directive 1999/5/EC.
Precision Novi™ System Information for Patients
90971728-03 REV A 16 of 491
Compliance Electromagnetic Environment Guide
Group 1 The Precision Novi 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 Precision Novi System is suitable for use in all establishments,
including domestic establishments and those directly connected to
Class B
the public low-voltage power supply network that supplies buildings
used for domestic purposes.
Complies