How Supplied

Contents are sterile for single use only.

Do not use if the package is opened or damaged.

Do not re-sterilise.

Contraindications

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

Cautions/Warnings

1. This device is designed for single use only, and is not to be reused or re-sterilised. Please do not re-use or re-process to avoid irreversible injury such as cross-infection or injury caused by device malfunction. Do not Use if package is opened or damaged.

2. Endoscopic 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.

3. Before endoscopic instruments and accessories from different manufacturers are utilised together in a procedure, verify compatibility and ensure that electrical isolation of ground is not compromised.

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

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

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

7. Instruments should not be opened while inside the cannula.

8. The site needs to be inspected for hemostasis after the trocar assembly is removed from cavity.

9. Do not attempt to use the trocar if the guard closes and does not move when you insert it into the cavity.

10.THE TROCAR TIP WILL BE BRIEFLY EXPOSED BEFORE INSERTION. STANDARD PROTECTIVE MEASURES USED FOR ALL TROCAR INSERTIONS MUST BE FOLLOWED. Intended Use

The Trocar and Cannula system has applications in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.

Instructions for Use

• The trocar is packed with the stopcock in the closed position. If insufflation is required, attach insufflation tubing to the stopcock on the cannula and open the stopcock (to stop insufflation, close the stopcock).

• Assemble the obturator and cannula together. To arm the blade, press the button on the obturator. Incise the skin in selected area adequately to accommodate trocar.

• Activate the protection shield by pressing the button on the front of obturator. Apply continuous downward pressure during entry of trocar. Once the cannula enters the cavity, the shield will advance forward and cover the exposed cutting edges. When the shield retracts, an audible “click” will be heard.

• With the trocar head in the palm of the hand apply continuous downward pressure progressing the trocar through the incision.

• When the instrument is in the desired position, remove the obturator and leave the cannula in place.