Boston Scientific Vessix Generator Mode D'emploi page 6

4. At this time, the generator will verify catheter connection (Figure 7). Prepare the Vessix Reduce™ Catheter according
to the catheter DFU.
5. The generator will display a model of the catheter with colored rings representing electrodes. During normal use with
the balloon in the folded state, electrodes may touch each other. If this occurs, a ring will display as red. If electrode
contact continues, an error message will indicate "Position balloon and inflate".
When the catheter is connected to the generator with the balloon exposed to air, electrode rings will be displayed
in grey. Navigate the catheter to the area of the renal artery to be treated and inflate the balloon as described in the
catheter DFU. Electrodes in contact with blood will display in purple (Figure 8).
6. Electrodes that achieve proper apposition against the vessel wall will be displayed in green. If the balloon is fully
inflated and electrodes remain purple, consider deflating and repositioning the balloon. If apposition is still not
achieved, replace catheter with one of a larger size and repeat from step 4.
7. As the balloon is inflated and apposition is achieved, electrodes may transition through an "almost there" zone and
display in yellow (Figure 9). Slowly continue to inflate until they transition from yellow to green. It is possible to treat
using electrodes displayed in yellow or green. The number of electrodes ready for treatment is displayed underneath
the bipolar electrode icon:
Press the Treat Button to begin therapy.
Black (K) ∆E ≤5.0
figure 7: catheter connection verification screen
figure 8: apposition screen ("blood contact")
figure 9: apposition screen ("almost there")
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