Boston Scientific DB-1110-C, Physician'S Manual

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BS EN 60601-1-2 Classification Information
Testing to demonstrate compliance of the Vercise™ System with the essential
requirements and other relevant provisions of Directive 1999/5/EC were leveraged
from testing performed on the Precision™ SCS System.
• Internally powered
• Continuous operation
• Ordinary equipment
• Class II
Table 1: Guidance and manufacturer’s declaration – electromagnetic emissions
The Vercise System is intended for use in electromagnetic environment specified
below. The customer or the user of the Vercise System should assure that it is used
in such an environment.
Emissions Test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The Vercise 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.
RF emissions
CISPR 11
Class B The Vercise System is suitable for use in
all establishments, including domestic
establishments and those directly connected
to the public low voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not
Applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
Applicable
Hereby, Boston Scientific declares that the Vercise 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: 0.4 mW (-4 dBm) maximum
• Magnetic Field Strength (at 3 m distance): 94 μA/m