Boston Scientific SPECTRA Manual Del Usuario página 19

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 Precision Spectra 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 Spectra System is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.
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 and those directly connected to the public low-voltage power supply network
Class B
that supplies buildings used for domestic purposes.
Complies
safety information
Precision spectra™ system information for Patients
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