OMS-T10SB

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Indications, Safety, and WarningsIndicationsThe instrument 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 extra-peritoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.ContraindicationsThis device is not intended for use except as indicated. In addition, it is not intended for use when endoscopic techniques are contraindicated.Warnings and precautions

The structural balloon trocar has been designed with a sheath to aid balloon insertion. Do not remove the sheath.

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.

Verify mechanical and electrical compatibility of devices from different manufacturers prior to using them together in a procedure.

This device is provided sterile and is intended for use in a single procedure only. Discard after use. Do not resterilize.

After removing the structural balloon trocar from the abdominal or extraperitoneal cavity, always inspect the site for hemostasis. If hemostasis is not present, appropriate techniques should be utilized.

Overinflation of the balloon may result in balloon rupture.

Balloon products must be treated with care. Damage to balloons from instruments used during the procedure may cause product failure.

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