Boston Scientific RF 3000 Gebrauchsanweisung Seite 15

Sink cuRRent, aPPlied PaRt
Sink current (or "isolated leakage sink current") is measured between mains input
and all output receptacles, at both normal and reverse polarity of mains voltage. Sink
current must be below 50µA.
Field SeRvice PRoceduReS
The only field-replaceable components of the RFG are the fuses, which are identified
in "Fuses" . Be sure to use the correct fuses and replace the fuse drawer in the proper
position for the mains voltage of the RFG, as marked on the fuse drawer.
For all other service requirements, please contact Boston Scientific.
diSPoSal
The user should follow local and national regulations for disposal of electronics
when disposing of this unit.
RF 3000™ Radio Frequency Generator Safety Specifications
D D
evice escription
Class I, Defibrillation proof Type CF Equipment, IPX0, not AP/APG
Mode of Operation: Continuous
EMC Emissions and Susceptibility: The RF 30 0 0 Radio Frequency Generator
has been tested and found to comply with the limits for medical devices to the
IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This system generates, uses, and can
radiate radiofrequency energy and, if not installed and used in accordance with the instruction
given below, may cause harmful interference to other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular installation.
e i
lectrical solation
Leakage current conforms to IEC 60601-1
Dielectric withstand conforms to IEC 60601-1
G
uiDance anD manufacturer
The RF 3000 Radio Frequency Generator is intended for use in the electromagnetic
environment specified below. The customer or the user of the RF 3000 Radio Frequency
Generator should assure that it is used in such an environment.
e t
missions est
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
'
s Declaration
c e
ompliance
Group 2 The RF 3000 Radio Frequency Generator
must emit electromagnetic energy in order
to perform its intended function. Nearby
electronic equipment may be affected.
Class A The RF 3000 Radio Frequency Generator is
suitable for use in all establishments other
than domestic and those directly connected
Class A
to the public low-voltage power supply
network that supplies buildings used for
Complies
domestic purposes.
15
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electromaGnetic emissions
lectromaGnetic environment
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GuiDance