How Supplied

Contents are sterile for single patient 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. Keep the pouch out of sharp instruments or edges. Pouch rapture may result in spillage of fluid or tissue specimen.

Intended Use:

Clearflow™ is a passive flow filter system used in laparoscopic surgery to evacuate smoke, particulates and aerosolized pathogens from the abdominal cavity without loss of pneumoperitoneum.

Instructions for Use:

ClearFlowTM Ultra:

1. Attach the ClearFlowTM Ultra to the side port of the trocar that is largest and closest to the source of smoke or mist.

2. Position the ClearFlowTM Ultra filter housing away from the operative site. Secure it to the surgical drape at a level elevated above the trocar.

3. Open the side port of the trocar to its full open position before smoke or mist is created. The ClearFlowTM Ultra is not a catchup device.

ClearFlowTM:

1. Attach the ClearFlowTM to the side port of the trocar that is largest and closest to the source of smoke or mist.

2. Position the ClearFlowTM filter housing away from the operative site.

3. Open the side port of the trocar to its full open position before smoke or mist is created. The ClearFlowTM is not a catch-up device