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The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This system monitors the power, resistance, current and temperature. The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient. VIVA combo RF System consists of S_VCS_F, MRFALogger and STAR Logger. The S VCS F software continuously monitors impedance, current, power and temperature. The unit automatically monitors rises in impedance and adjust RF output accordingly. MRFALogger software can be stored and monitored on PC or tablet the RF output parameter (power, impedance, current, temperature and energy). STAR Logger can be stored and monitored on a tablet PC the RF output parameter (power, impedance, current, temperature and energy).

VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux.

VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump. The generator generates, controls and monitors RF energy and delivers energy to the active electrode. The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels. The single footswitch works as an on/off switch and the double footswitch works to increase the power output. A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes.

The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and billiary tracts.

The ELRA Electrode is a bipolar electrode. ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides. The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French. The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.

Star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

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The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

The ELRA Electrode is a bipolar electrode. ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides. The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French. The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.

The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This system monitors the power, resistance, current and temperature. The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient. The VIVA combo RF system consists of S VCS F, MRFALogger and VIVALogger software. The S_VCS_F software continuously monitors impedance, current, power and temperature. The unit automatically monitors rises in impedance and adjust RF output accordingly. MRFALogger software can be stored and monitored on PC the RF output parameter (power, impedance, current, temperature and energy). VIVALogger software can be stored and monitored on a tablet PC the RF output parameter (power, impedance, current, temperature and energy).

The EUSRA RF Electrode is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

The EUSRA RF Electrode is a monopolar electrode. The EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The EUSRA RF Electrode consists of the tubing set and grounding pad. The grounding pad is FDA cleared (K163450). The EUSRA RF Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of EUSRA RF Electrode are stainless steel 304, polyimide, polyether block polyamide copolymer and PTFE. Cooling of the EUSRA RF Electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.

star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

The star/VIVA RF Electrodes are a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The star/VIVA RF Electrodes consists of the tubing set, PC pipe, PC plug and grounding pad. The grounding pad is FDA cleared (K163450). The star/VIVA RF Electrodes consist of an electrode tip, insulation part, handle and tubing. Patient contacting materials of star RF Electrode are stainless steel 304 and polyester, and patient contacting materials of VIVA RF Electrode are stainless steel 304 and polyimide. Cooling of the electrode is provided by chilled water which is pumped the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient. The star/VIVA RF Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the star RF Electrode range from 7 cm to 20 cm and VIVA RF Electrode range from 15 cm to 20 cm. The tip exposures available for the star RF Electrode range from 5 mm to 20 mm and VIVA RF Electrode range from 5 mm to 30 mm. The exposed length of the VIVA RF Electrode can be adjusted by the control button on the handle. The diameters available for the star RF Electrode diameters are 17 Gauge. The diameters available for the VIVA RF Electrode diameters are 15 Gauge and 17 Gauge.

The VIVA combo RF Ablation System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature. The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.