Vessix ™ Generator; Introduction; Device Operation - Boston Scientific Vessix Generator Mode D'emploi

Vessix Generator
™
Operator's Manual
ONLY
caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

IntroDUctIon

The Vessix Generator is part of the Vessix™ System, which includes the Vessix Generator mounted on a roll cart or table
stand, Vessix Reduce™ Catheter, patient extension cable and external power supply (Figure 1). The Vessix Generator is a
portable bipolar radio frequency generator (RFG). It interfaces with the Vessix Reduce Catheter, which is a low-pressure,
percutaneous angioplasty balloon catheter designed to deliver low-power radio frequency (RF) energy into the renal
artery. After catheter connection, there is a single button that activates therapy. Please refer to the Vessix Catheter or
Vessix Reduce Catheter Directions for Use (DFU) for more information regarding catheter usage.
figure 1: the vessix system

DevIce operatIon

The Vessix Generator has a bright 9 inch diagonal color LCD screen, user-friendly user interface, indicator lights (LEDs)
and two physical buttons. The RF treatment frequency is 480 kHz. An external power supply converts wall mains AC to 15
VDC to power the RFG. An internal rechargeable lithium-ion battery allows the RFG to perform therapy while disconnected
from mains power.
The Vessix Reduce Catheter connects directly into the RFG or via a 3 meter patient extension cable. The RFG and patient
extension cable reside outside the sterile field. The Vessix Generator is mounted to a 42 inch tall mobile cart or a table
stand via a universal GCX mount. Since the Vessix Generator uses bipolar technology, it does not use a neutral/external
return electrode. Only one Vessix Reduce Catheter can connect to the generator at a time.
the vessix system should only be used by physicians trained in angiography and percutaneous interventional
techniques.
carefUlly reaD all InstrUctIons prIor to Use. oBserve all WarnInGs anD precaUtIons noteD In these
DIrectIons anD In the vessIx reDUce catheter DIrectIons for Use. faIlUre to Do so May resUlt In
serIoUs coMplIcatIons.
3
Black (K) ∆E ≤5.0