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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>The Spacemaker™ dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.</p> <p>The Spacemaker™ blunt tip trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.</p> <p>The Spacemaker™ structural balloon trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy, or bladder neck suspension procedures.</p> <h3>Warnings</h3> <ul> <li>Care must be exercised during insertion of the balloon as well as during the course of the procedure to avoid damaging the balloon with other instruments.</li> <li>Over inflation of the dissection balloon may cause the balloon to rupture. Do not exceed 40 pumps.</li> <li>Over inflation of the Spacemaker™ Pro blunt tip trocar or Spacemaker™ Pro structural balloon trocar balloon may result in balloon rupture. Do not exceed the recommended fill volume.</li> <li>Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user and/or patient.</li> <li>Verify mechanical and electrical compatibility of devices from different manufacturers prior to using them together in a procedure.</li> <li>This device is provided sterile and is intended for use in a single procedure only. Discard afater use. Do not resterilze.</li> <li>Care must be exercised not to tunnel too deeply. Avoid forcing the balloon in a manner that may cause trauma to nearby organs and structures.</li> </ul> <h3>Contraindications<br /> </h3> <ul> <li>The Spacemaker™ structural balloon trocar, Spacemaker™ blunt tip trocar, and Spacemaker™ dissection balloon devices are not intended for use except as indicated. In addition, they are not intended for use when endoscopic techniques are contraindicated.</li> <li>Use of Spacemaker™ dissection balloons are contraindicated in situations where previous surgeries in the extraperitoneum may have created adhesions in the area of extraperitoneal organs.</li> </ul> <p>Please refer to instructions for use for complete contraindication and risk information.</p>

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