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The everlinQ® endoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using the ulnar artery and ulnar vein in patients with minimum artery and yein diameters of 2.0 mm and less than 2.0 mm separation between the artery and vein at the fistula creation site who have chronic kidney disease and need hemodialysis.

The everlinQ® endoAVF System (everlinQ®) consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter, both of which are 6 Fr in diameter. The venous catheter contains an electrode for delivery of radiofrequency (RF) energy while the arterial catheter contains a ceramic backstop that serves as a mechanical stop for the electrode. The everlinQ® is used with a commercially available electrosurgical unit (ESU) and electrosurgical pencil.

The ESU-1 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The ESU-1 Electrosurgical Generator is a high frequency isolated generator that utilizes electrical current via an assortment of surgical devices to cut and coagulate different types of tissue. The ESU-1 Electrosurgical Generator features cutting up to 300 watts with 2 cut modes, including "Cut T", a blend mode with 4 levels, 3 coagulation modes and 4 bipolar modes with Auto Bipolar option. "Cut T" mode is a new feature that includes a timing feature which automatically ceases RF activation after a user selectable period of time that can be altered between 0.1 and 3.0 seconds. The RF activation for Cut T mode is initially pre-set at 2 seconds (Note: if the operator changed these settings, the generator will powerup with the mode and setting in which the operator last activated the generator). The generator offers 2 monopolar headpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode sensing feature allows the user to use either a split or solid return electrode site. The padsensing feature allows the user to use either a split or solid return electrode. The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).