WPXLGR1117

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications/intended purpose</h3> <ul> <li>The SurgiSleeve™ wound protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery.</li> <li> Additionally, the small size wound protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. </li> <li>The extra small wound protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.</li> <li>The intended purpose of the device is to retract the incision while providing access to abdominal and thoracic cavities during surgical procedures while protecting the incision from surgical site infections.</li> </ul> <h3>Clinical benefits</h3> <p>The device provides the clinical benefit of protecting the surgical incision site from microbial infection.</p> <h3>Contraindications<br /> </h3> <p>Use of the SurgiSleeve™ wound protector is contraindicated when, in the judgment of the physician, use of this device would be contrary to the best interest of the patient.</p> <h3><span style="font-weight: normal;">Warnings and precautions</span></h3> <ul> <li>Use care when introducing or removing sharp-edged or sharp-angled endoscopic instruments to minimize the potential of inadvertent damage to the SurgiSleeve™ wound protector.</li> <li>This device is provided sterile for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.</li> <li>Anesthesiologists should carefully monitor for hypotension when a retractor with an inner-ring is used in lower abdominal surgery.</li> </ul>

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