Boston Scientific Precision Novi Guia De Informacion página 13

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 IPG 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.
Notice to the User Per Industry Canada Radio Standards Specifications:
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
1. This device may not cause interference, and
2. This device must accept any interference, including interference that may cause undesired
operation of the device.
Compliance
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
Class B
establishments and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domestic
Complies
purposes.
Precision Novi™ System Information for Prescribers
Electromagnetic Environment Guide
90962628-03 Rev A
Safety Information
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