taBle of contents
IntroDUctIon ............................................................................................................................................................................................. 3
Figure 1: The Vessix™ System ........................................................................................................................................................ 3
DevIce operatIon ..................................................................................................................................................................................... 3
DevIce InstallatIon ................................................................................................................................................................................ 4
InDIcatIons ................................................................................................................................................................................................. 4
contraInDIcatIons ................................................................................................................................................................................ 4
potentIal aDverse effects ................................................................................................................................................................. 4
controls anD InDIcators ................................................................................................................................................................... 4
Buttons ...................................................................................................................................................................................................... 4
Bottom Connectors ................................................................................................................................................................................. 5
LED Indicators .......................................................................................................................................................................................... 5
UsInG the vessIx™ Generator systeM ......................................................................................................................................... 5
Figure 5: Splash Screens ................................................................................................................................................................ 5
Figure 6: "Waiting for Connection" Screen ................................................................................................................................. 5
Figure 7: Catheter Connection Verification Screen .................................................................................................................... 6
Figure 8: Apposition Screen ("blood contact") ........................................................................................................................... 6
Figure 9: Apposition Screen ("almost there") ............................................................................................................................. 6
Figure 10: Apposition Screen ("partial activation") ................................................................................................................... 7
Figure 11: Apposition Screen ("full contact").............................................................................................................................. 7
Figure 12: Treatment Screen ........................................................................................................................................................... 7
Figure 13: Treatment Summary Screen ........................................................................................................................................ 7
WarnInGs anD caUtIons ..................................................................................................................................................................... 9
Maintenance/ Cleaning ....................................................................................................................................................................... 10
Troubleshooting ..................................................................................................................................................................................... 10
Service ................................................................................................................................................................................................... 10
Warranty .................................................................................................................................................................................................. 10
specIfIcatIons ......................................................................................................................................................................................... 11
Electrical Specifications ...................................................................................................................................................................... 11
Physical Specifications........................................................................................................................................................................ 11
Environmental Specifications ............................................................................................................................................................. 11
Figure 14: Vessix Generator System Output Power & Voltage Curves ................................................................................ 12
Table 1: Guidance and manufacturer's declaration - electromagnetic emissions ........................................................... 12
Table 2: Guidance and manufacturer's declaration - electromagnetic immunity ............................................................. 13
Table 3: Guidance and manufacturer's declaration - electromagnetic immunity
Table 4: Recommended separation distances between portable and mobile RF communications equipment
and the Vessix Generator .............................................................................................................................................................. 15
Black (K) ∆E ≤5.0
...................................................... 14
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