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Image of the SpaceMaker™ Pro access and dissector system

Indications, Safety, and WarningsIndicationsThe Spacemaker™ dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.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.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.Warnings

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.

Over inflation of the dissection balloon may cause the balloon to rupture. Do not exceed 40 pumps.

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.

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 afater use. Do not resterilze.

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.

Contraindications

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.

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.

Please refer to instructions for use for complete contraindication and risk information.

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