En 60601-1-2 Classification Information - Boston Scientific Precision Spectra Manual Del Usuario

Information for Prescribers

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 Spectra™ 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 Spectra 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.
Precision Spectra™ System Information for Prescribers
90668524-11 REV A 8 of 165
Compliance Electromagnetic Environment Guide
Group 1 The Precision Spectra 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 Spectra System is
suitable for use in all establishments.
Including domestic establishments
Class B
and those directly connected to the
public low-voltage power supply
network that supplies buildings
Complies
used for domestic purposes.