Description:

The Balloon Cannula and Optical Trocar is a sterile and single-use product. It consists of a cannula with Balloon and gel anchor grip, a visible obturator, and an empty syringe.

Intended Use:

The Balloon Cannula and Optical Trocar has applications in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. This device has a gel anchor grip and balloon to provide inner and outer stabilization and minimize the fascial trauma during the surgery.

Contraindications

This product is not intended for use when endoscopic techniques are contraindicated.

Instructions for Use

1. The trocar is packed with the stopcock in the open position. Close the stopcock after removal from package. If insufflation is required, attach insufflation tubing to the stopcock on the cannula assembly and open the stopcock (close the stopcock to stop the insufflation).

Caution: Verify the balloon is fully deflated prior to use. Attach the syringe onto the balloon inflation port and pull out on the syringe to deflate the balloon.

2. Assemble obturator and cannula together. A laparoscope may be used by inserting it into port on the top rear of the obturator. This will aid visualizing the passage of the trocar through the tissue layers.

3. Balloon trocar 12mm is compatible with 4.8mm to 13.1mm sized instruments with its built-in universal seal without the use of converter. Balloon trocar 10mm is compatible with 4.8mm to 11.85mm sized instruments with its built-in universal seal without the use of converter. Balloon Trocar 5mm is compatible with 4.8mm to 5.85mm sized instruments.

4. An incision should be made smaller than the diameter of the cannula.

5. When the trocar is in the desired position, remove the obturator.

6. Pull the pistol of the syringe to the maximum and push the pistol to the end to inflate the air to the balloon. The maximum volume of the 10/11mm-12mm syringe is 10ml and the maximum volume of the 5mm syringe is 5ml, which is the exact volume of air needed to make a full balloon. Caution: Over inflation of the balloon can cause the balloon to burst.

7. Adjust the gel anchor grip so that the gel can softly fix the cannula to patient’s abdomen.

8. To remove the cannula, use the syringe to deflate the balloon and remove the cannula from the site.

9. For specimen removal, simply remove the upper cannula housing.

Warnings and Precautions

• Do not allow sharp instruments or objects to come into contact with balloon. Use caution around metal clamps, staple lines and during secondary port placement.

• This device is EO sterilized and for single use only. Please do not re-use or re-process to avoid irreversible injury, infection and device malfunction.

• Trocar procedures should be performed only by physicians with adequate training and knowledge of these procedures. In addition, medical literature should be consulted regarding techniques hazards, contraindications and complications prior to the performance of these procedures.

• Verify that the sizes of all surgical components selected are compatible.

• Instruments should not be opened while passing through the access port.

• The site should be inspected for hemostasis after the assembly is removed from cavity.

• Do not use when the package is opened or damaged.

• Store this device in a dry, clean and safe place. Keep the device away from flammable and combustible chemicals or materials.

• Please follow universal guidelines upon medical waste disposal to avoid any potential cross-infection, environmental contamination or injury caused by sharp waste.