En 60601-1-2 Classification Information - Boston Scientific Precision SC-1110 Mode D'emploi

Système de stimulation médullaire
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EN 60601-1-2 Classification Information

• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
Table 1 – Guidance and manufacturer's declaration – electromagnetic emissions
The Precision System is intended for use in electromagnetic environment specified below.
The customer or the user of the Precision 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 System is in compliance with the essential requirements and other
relevant provisions of Directive 1999/5/EC.
Compliance
Electromagnetic Environment - guidance
Group 1
The Precision 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 System is suitable for use in all
establishments, including domestic establishments
Not Applicable
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Not Applicable
EN 60601-1-2 Classification Information
91173656-02
Clinician Manual
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