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The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.

The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components: - RF Ablation System - Ultrasound Visualization System - Guidance System The following accessories connect to the console: - Dual Foot pedal (one for RF ablation and one for coagulation) - Video Cable - Power Cord - Acessa Pads and Acessa Pad Cable - Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable - Acessa Transducer, either: - Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (embedded with sensor), or - Acessa ProVu Transducer with (embedded) sensor - Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator - Monitor (hospital-owned accessory monitor, not provided by Acessa) The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal. The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended as an optional accessory for use during the Acessa System procedure.

The Acessa Guidance System consists of the following components: Guidance Controller (Model Number 5100), Guidance Ultrasound Transducer Sleeve (Model Number 5500), Guidance Field Generator (Model Number 5200), Guidance Handpiece Cable (Model Number 5400), and Power Cord (Model Number 4110). The Acessa Guidance System uses electromagnetic tracking technology to track the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Guidance Handpiece shaft's future path in relation to the features in the ultrasound slice. The Acessa Guidance System is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The Acessa Guidance Handpiece is indicated for use in percutaneous laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

Acessa Guidance Handpiece (Model Number 5300): The Acessa Guidance Handpiece, when used with the tracking system, is meant to guide the tip of the Handpiece up to the uterine serosa. Once the device is advanced into the uterus, standard ultrasound views are used to guide the tip to the fibroid. Ultrasound visualization for fibroid penetration and treatment remain unchanged. The Acessa Guidance Handpiece is a single-use only, sterile, radiofrequency (RF) applicator that connects to the Acessa Generator by a custom Cable. The Handpiece consists of a handle with a trocar shaft, active needle tip, and seven deployable needle electrodes each with embedded thermocouple sensors for real-time temperature feedback. The Acessa Guidance Handpiece also has control buttons that allow the user to access the User Interface. This Acessa Guidance Handpiece also contains the magnetic guidance sensor used to determine spatial location. The embedded sensor and SROM can be used with the electromagnetic tracking technologies to track the positions of an Ultrasound Transducer and the Handpiece shaft, and draws virtual representations of them in their spatial relationship, so that a physician can predict the Handpiece shaft's future path in relation to the features in the ultrasound slice. These electromagnetic tracking technologies are considered optional accessories to Acessa System procedure.

The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa System includes the following system components: Generator (Model Number 1000): Provides RF energy to the Handpiece through the Handpiece Cable. Handpiece (Model Number 2000): Consisting of a disposable handle with a trocar-pointed shaft and 7 deployable needle electrodes. For use only disposable electrosurgical devices provided by Halt Medical, Inc. Handpiece Cable (Model Number 4200): Connects Handpiece to the Generator. This extension cable is provided with the Generator. Pads (Model Number 3000): A disposable set of 2 units, providing the return path for the RF energy applied by the Handpiece. Use only the Pads provided by Halt Medical, Inc. Pad Cable (Model Number 4300): Connects the Pads to the Generator. This extension cable is provided with the RF Generator. Power Cord (Model Number 4110): A medical grade power cord that provides AC power to the Generator. The Power cord is provided with the Generator. Foot Pedal (Model Number 4100): Pneumatic foot pedal with tubing used to turn RF energy on and off. The Foot Pedal with tubing is provided with the Generator. The Acessa System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Manual Control and Coagulation Mode. A touch screen with a graphical user interface (GUI) enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal. NOTE: The Acessa System must be used under laparoscopic ultrasound guidance. Laparoscopic ultrasound equipment is not included with the Acessa System.

The MicroMed PD-8K system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.

The MicroMed PD-8K system (MMPD-8K) is comprised of a reusable hand-held instrument probe, a detector or control/base unit, a ground wire and a high voltage wire in which the appropriate electrode (instrument probe) is control with and a fight vone in a mich in appropriate electrode housed at the end of the detector (control/base) unit The battery adaptor (recharger) is provided with the system for recharging the battery. The MicroMed PD-8K electrodes are reusable. MicroMed PD-8K System includes: - Detector (base unit) - Battery with Charging adaptor - Probe handle with 2m (6ft) lead-Red HV Wire - 2m (6ft) lead ground wire with clamp-Green Wire - Brush electrode 8mm (0.31inch) wide brass wires - Ring Electrode with brass wires - Carrying case - Standard Operating Instruction manuals. CD With additional information.

The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.

The InsulScan™ system is comprised of a disposable hand-held instrument probe, a control unit, a cable adapter, and a ten-foot long connection cable. The InsulScan™ system is powered by a rechargeable battery housed in the control unit. A battery recharger unit and battery charger cable are provided for recharging. The InsulScan™ probe is provided sterile, single use and may not be resterilized.

The Laparoscopic Unipolar Tips will serve as accessories to the Endo-Tech, Ltd, Inc.,Endo-Aid, which is an Aspiration- Irrigation Device. These tips will thread into the laparoscopic irrigation and aspiration control handle. The tips will be used during laparoscopic procedures and electrosurgical procedures.

The Laparoscopic Unipolar Tips will be threaded into the Endo-Tech, Ltd., Inc. Endo-Aid (K#930756) and will be used during Laparoscopic procedures. These tips will be used by a range of surgeons for various abdominal procedures in a hospital operating room environment. The Laparoscopic Unipolar Tips consist of the following components: Threaded adapter (Male), Thread on probe and stainless tip (Female:Spatula, L Hook, J Hook, and Needle), Insulation Sheath for Electrosurgical Tips (Ratcheting).