Renuvion RS3 Generator System - Salient Characteristics DRAFT.pdf

Salient Characteristics

Renuvion RS3 Generator

INDICATIONS FOR USE

The Renuvion System Generator (owned by Apyx Medical) is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/J-Plasma handpieces.

DEVICE DESCRIPTION

The Renuvion System Generator is an electrosurgical device that delivers radiofrequency (RF) energy to cut and coagulate soft tissue. It can also deliver Helium plasma energy for cutting, coagulation, and ablation of soft tissue. The Renuvion System Generator is essentially a combination of a standard electrosurgical generator and a Helium Plasma generator.

CONTRAINDICATIONS

None

OPERATING PRINCIPLE

RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut, coagulate and ablate tissue.

Input Voltage 100-240V~ ± 10%

KEY FEATURES

The generator includes the latest technology. This unit offers unsurpassed performance, flexibility, reliability, and convenience.

It includes the following features:

-Two Cut Modes, Cut I & Cut II

Two cut modes give the surgeon flexibility to cut all types of tissue without losing performance. Cut I generates constant output power over a wide range of impedances. Cut II is a softer cut that generates constant output power with a lower voltage over a small range of impedances suggested for laparoscopic procedures.

-Three Levels of Blend

The Blend mode is a combination of cutting and hemostasis. The Blend mode improves the rate of targeted tissue desiccation without increasing the power delivered by the generator.

Three Levels of Coagulation: Pinpoint, Spray and Gentle Coagulation

– Pinpoint – Pinpoint provides precise control of bleeding in localized areas.

– Spray – Spray provides greater control of bleeding in highly vascular tissue over broad surface areas.

– Gentle – Gentle offers more concentrated coagulation than in other modes. For instance, when coagulation is necessary in short amounts of time, reduced electrode carbonization is provided.

Three Bipolar Modes: Macro, Micro and Standard with an Auto Bipolar option

For procedures requiring Bipolar output power, the generator offers the surgeon three Bipolar modes.

– Macro Bipolar Mode - The Macro Bipolar Mode provides rapid Bipolar coagulation or bipolar cutting effects to prevent tip tissue adhesion and carbonization.

– Micro Bipolar Mode – The Micro Bipolar Mode provides precise Bipolar coagulation effects.

– Standard (Std) Bipolar Mode – The Standard Bipolar Mode provides power for conventional Bipolar output.

– Auto Bipolar – The Auto Bipolar feature is disabled by default. When the user manually enables this feature, if the generator senses that the impedance is between 20 -1000 ohms, the unit will activate the selected bipolar mode after a delay of 1 second without the need to activate the footswitch.

Settings

For procedures requiring energy dispensed helium gas plasma, the generator offers plasma with adjustable gas flow and pulsing energy. This setting is intended to be used along with the desired coagulation setting for “painting” of the designated surgical area with the powered plasma stream or for “spot” coagulation of limited and short activation duration.

– Power - The Plasma mode allows adjustable Power percentage (%) settings in increments of 5%.

– Pulse Settings - Adjustable pulse settings from Power ON: 0 - 980 ms to Power OFF: 0 - 980 ms, in steps of 20ms, to allow the user the ability to pulse the plasma output power on and off.

– Gas Flow - The gas flow rate can be adjusted in steps of 0.5L/min from 1.0 – 5.0L/Min.

– Energy Counter – When enabled by the user, this feature provides a time counter to calculate the accumulated energy in kilojoules based on the Power setting and the duration of activation. The user can set a value on the Energy Counter to notify when the accumulated energy has been reached. Simple interface lets the user configure a set point and reset the current accumulated value. Audio tones notify the user once a set point has been reached.

Presets

The surgeon can store 10 user-defined presets for easy recall of frequently used settings.

-Interface Dimming at Activation

This feature allows clear visualization of the activated mode. When a mode is activated, all other illuminated modes will dim leaving only the activated mode at full/bright illumination.

-Return electrode sensing and contact quality monitoring

-continually monitors the contact quality between the patient and the split return electrode.

This feature is designed to minimize patient burns at the return electrode site.

-The FDFS (Fast Digital Feedback System) measures voltage and current at 5,000 times a second

-immediately adjusts the power to varying impedance during the electrosurgical procedure.

-The unit’s digital technology senses and responds to changes in tissue density.

-this feature reduces the need to adjust power settings manually with varying tissue impedance.

-Digital interface with membrane switch feature selection.

-Front Panel Accessory Connections

-Three Rear Panel Footswitch Connections and Rear Panel Gas Connections

These connectors accept the latest monopolar, bipolar and plasma instruments.

-The unit automatically powers up to the last activated modes and power settings.

-Isolated RF output

This minimizes the potential of alternate site burns.

-Self-diagnostics

These diagnostics continually monitor the unit to ensure proper performance.

-user may adjust the power setting for the mode being activated up to 5 increments up or down.