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INDICATIONS FOR USE AS A RESECTION ELECTRODE:

The Dornier Bi Polar Electrode is designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation, or removal of soft tissue and where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedure for which the devices can be used are: Transurethral resection in saline (TURis), Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, Transurethral incision of the prostate (TUIP) or bladder neck, Transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

The following electrodes are intended to be used as resection electrodes:

• BIP12CLL: BIPOLAR 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIP12CLM: BIPOLAR 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIP30CLL: BIPOLAR 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIP30CLM: BIPOLAR 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIPMBLA: BIPOLAR Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use
• BIPNEEL: BIPOLAR Needle 24 Fr Electrode-Sterile, Single-Use

INDICATIONS FOR USE AS A VAPORIZATION ELECTRODE:

The Dornier Bi Polar Electrode is designed and intended for use in urological surgical procedures involving vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indication include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethal Electro vaporization (TUVP), (TVP), (TUEVP) also known as Transurethal Vapor Resection of the prostate (TUVRP), Transurethal Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

The following electrode is intended to be used for plasma vaporization:

• BIPDDSC: BIPOLAR Dornier Disc™ 24 Fr Electrode-Sterile, Single-Use

The Dornier Bipolar electrodes are sterile packaged, bipolar electrodes designed to deliver high frequency electrosurgical energy at the treatment area of the patient. Dornier bipolar electrodes are intended for single-use only.

The electrodes are designed to be connected through a compatible resectoscope to the electrosurgical unit for the delivery of electrosurgical energy at the treatment area of the patient. It is suitable for surgical cutting, coagulation and removal of soft tissues by controlled heating effect.

The Dornier Bipolar Electrode shall be used in conjunction with compatible resectoscopes such as Olympus Bipolar 12° and Olympus Bipolar 30° to the compatible bipolar electrosurgical generator such as Gyrus PlasmaKinetic™ SuperPulse Generator and Olympus ESG 400.

Electrical energy is supplied by the generator. A cable is connected from the generator to the working element of the Resectoscope. The Positive lead attaches to the bottom of the working element and the negative to the top of the working element. Electrical current flows from the generator into the Connector, down the Inner Tube and into the tip of the probe, creating a plasma field. The current returns via the saline, through Forks and Scope, into the negative lead and back to the generator. The strength of the plasma field can be adjusted by increasing or lowering the power setting on the generator. A foot switch is used to turn the electrode on and off.

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