Boston Scientific Vercise PC Mode D'emploi page 13

• Seroma, edema or hematoma
• Skin irritation or burns at neurostimulator site
• Speech or swallowing problems such as dysphasia, dysarthria or dysphagia, as well as
complications of dysphagia such as aspiration pneumonia
• Systemic symptoms-autonomic (tachycardia, sweating, fever, dizziness), changes in
renal function, urinary retention, sexual effects, gastrointestinal (nausea, bowel retention,
bloating)
• Thrombosis
• Visual disturbances or periorbital symptoms, such as diplopia, eyelid movement difficulty,
oculomotor difficulties or other visual field effects
• Weight changes
BS EN 60601-1-2 Classification Information
Testing to demonstrate compliance of the Vercise PC DBS 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 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.
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.
Safety Information
Vercise™ PC Information for Prescribers
90985313-04 Rev A 9 of 423