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The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, incision, and hemostasis in soft tissue surgical procedures.

The subject device Soniquence Reusable 3 Button Fingerswitch Wand is an accessory to the Soniquence SmoothWave RF Generator. It is connected to a High Frequency Generator via the male end, and the female end termination connects to the Monopolar Electrode. This device will be provided non-sterile and is intended to be used with Soniquence Monopolar Electrodes. The 3-Button Fingerswitch Wand includes access to all three monopolar waveforms without unit manipulation. This patented, unique handpiece is utilized to activate CUT, BLEND, and HEMO modes via finqerswitch for general surqical procedures. The depressed button function will be the actual output function and disregards the front display settings. The fingerswitch operational features are as follows: a) The CUT button will activate CUT mode. When depressed, the vellow indicator (CUT) illuminates. b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates. c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.

The Soniquence Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Soniquence Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.

The Soniquence Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of the reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.

The Soniquence Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.

The subject device, Soniquence Reusable Bipolar Cable is a bipolar accessory designed to transfer the electrosurgical power to the Bipolar electrode. It is connected to a High Frequency Generator via the male end and the female end termination connects to the standard Bipolar instrument. The cable is made of Silicone material and Polypropylene H1500 which is flexible and autoclavable. The length of the cable is 3 meters, and it is provided non-sterile.

The Soniquence Bipolar Electrode is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed.

The Soniquence Bipolar Electrodes family is a line of disposable bipolar electrosurgical devices which is intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. The basic design of the Soniquence Bipolar Electrodes is a plastic handle, an elongated, insulated electrode shaft, a bipolar electrode tip, and an integrated cable and plug which is designed to connect exclusively to the Soniquence line of high-frequency RF energy sources. The operational principle of the device is common to all active bipolar electrosurgical devices; the active tip of the Soniquence Bipolar Electrode emits RF energy generated according to settings established on the Soniquence RF generator which emits high frequency, low temperature radiowaves directed to the electrode tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. This energy is capable of cutting or coagulating target tissue depending on the waveform associated with the mode and power setting of the generator. The devices are disposable and intended for single-use only. The devices are intended for transient contact with the patient, and are provided sterilized by ethylene oxide and has a shelf life of three years from the date of sterilization.

The Soniquence RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. The Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.

The Soniquence RF Generators® are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutuallyexclusive use with the Soniquence® line of generators. All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches. Soniquence Electrodes are used with the Soniquence RF Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Soniquence family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel). These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.