OMS-TTSD

Indications, Safety, and WarningsThe Tacker™ fixation device is indicated to affix prosthetic material or approximate tissue in a variety of endoscopic or other surgical procedures. Warnings

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

The reusable handle may be resterilized four times for a total of five uses. Dispose of the handle after the intended five uses.

Resterilization of the reusable handle after the intended number of uses may compromise the integrity of the product, which may result in product malfunction.

Detergents and solutions should have a pH between 7.0 and 9.5.

Sterilization temperature should not exceed 275 F (135 C).

Contraindications

Do not use the Tacker™ fixation device on tissue(s) which cannot be inspected visually for hemostasis.

A minimum of 4 mm tissue thickness is required when applying the helical fastener over underlying bone, vessels, or viscera. If the total distance from the surface of the tissue to the underlying structure(s) is less than 4 mm, or may be compromised to a total distance of less than 4 mm, use of the device is contraindicated.

This device should not be used in tissues that have a direct anatomic relationship to major vascular structures. This would include the deployment of helical fasteners in the diaphragm in the vicinity of the pericardium, aorta, or inferior vena cava during diaphragmatic hernia repair.

Do not use in ischemic or necrotic tissue.

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

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