ONB12STF

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<h2>Indications, Safety, and Warnings</h2> <h3><span style="font-weight: normal;">Indications</span></h3> <p>The VersaOne™ optical trocars are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.</p> <h3><span style="font-weight: normal;">Contraindications</span></h3> <ul> <li>This device is not intended for use when endoscopic techniques are contraindicated.</li> <li>This device is not intended for use except as indicated.</li> </ul> <h3><span style="font-weight: normal;">Warnings and precautions</span></h3> <ul> <li>Failure to establish and maintain appropriate pneumoperitoneum in abdominal procedures may reduce available free space, increasing the risk of injury to internal structures.</li> <li>Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. Medical literature relative to techniques, complications, and hazards should be consulted prior to use.</li> <li>An insufficient skin incision may cause increased penetration force which may reduce the surgeon’s control during entry. An incision too large may increase the potential for port instability.</li> <li>The optical features in the distal end of the obturator are intended to minimize the likelihood of penetrating injury to intra-abdominal and intra-thoracic structures, however, standard precautionary measures employed in all obturator insertions must be observed.</li> <li>Before and after removal of the VersaOne™ optical trocar from the abdominal or chest cavity, inspect the site for hemostasis. Bleeding may be controlled by electrocautery or manual sutures.</li> <li>Thoracoscopy is indicated when a limited intrapleural space exists (air or fluid filled). For this reason, needle aspiration through the selected site is indicated prior to inserting the trocar.</li> <li>Before endoscopic instruments and accessories from different manufacturers are used, verify compatibility and ensure that electrical isolation or grounding is not compromised.</li> <li>A thorough understanding of the principles and techniques involved in laser laparoscopy and electrosurgical procedures is essential to avoid shock and burn hazards to both patient and operator(s), and damage to the instrument.</li> <li>Closure of the fascia is at the discretion of the surgeon. Underlying fascia may be closed, e.g., by suturing to reduce the potential for incisional hernias.</li> <li>Use care when introducing or removing sharp-edged or sharp-angled endoscopic instruments to minimize the potential of inadvertent damage to the seal.</li> <li>In abdominal procedures, the incorrect perpendicular trocar insertion could result in an aortic puncture or abdominal aorta.</li> <li>This device is provided sterile and is intended for use in a single procedure only. Discard after use. Do not resterilize.</li> </ul>

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