Essential Performance; Telemetry Information - Boston Scientific Vercise PC Instrucciones De Uso

Vercise™ PC Information for Prescribers
Table 1: Guidance and manufacturer's declaration – electromagnetic emissions
The Vercise PC System is intended for use in electromagnetic environment specified below.
The customer or the user of the Vercise PC 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 Vercise PC System is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC.

Essential Performance

Failure of the external electrical components will not result in an unacceptable risk to the user.

Telemetry Information

The following parameters describe the wireless communication link between the Stimulator and the
Remote Control:
• Frequency Band: 119 – 131 kHz
• Modulation type: FSK
• Effective Radiated Power: 0.05 mW (-13 dBm) maximum
• Magnetic Field Strength (at 3 m distance): 46 μA/m
Vercise™ PC Information for Prescribers
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Compliance Electromagnetic environment –
guidance
Group 1 The Vercise PC 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 Vercise PC System is suitable for use
in all establishments, including domestic
establishments and those directly connected
Not Applicable
to the public low voltage power supply
network that supplies buildings used for
Not Applicable
domestic purposes.