Guidance And Manufacturer's Declaration - Boston Scientific Vessix Generator Mode D'emploi

Output Power vs. Load Resistance
20
15
10
5
0
0 500 1000 1500
Load Resistance ( )
figure 14: vessix™ Generator system output power & voltage curves

GUIDance anD ManUfactUrer's DeclaratIon

This equipment has been tested and found to comply with applicable safety portions of the IEC 60601-1:2005 standard as
modified by the particular standard IEC 60601-2-2:2009.
This equipment has been tested and found to comply with the following EMC standard: EN 60601-1-2:2007. as modified by
the particular standard EN 60601-2-2:2007.
table 1: Guidance and manufacturer's declaration – electromagnetic emissions
The Vessix™ System is intended for use in the electromagnetic environment specified below. The customer or the user of
the Vessix 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)
Black (K) ∆E ≤5.0
2000 2500 3000 3500
compliance electromagnetic environment – guidance
The Vessix Generator intentionally emits RF energy at 480 kHz as
Group 1 this is the therapy being delivered. It must comply with Group 1
emissions when switched "on" with the RF output not energized.
Class A
Class A The Vessix Generator is suitable for use in all commercial
establishments.
Complies
12
Output Voltage vs. Load Resistance
50
40
30
20
10
0
0 500 1000 1500 2000
Load Resistance ( )
2500 3000 3500