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 resterilised. 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. A thorough understanding of techniques and principles involved in electrosurgical procedures is necessary to avoid burn or shock hazard to patient and or operator.

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

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

7. LaproSurge Laparoscopic instruments can only be used with monopolar electrosurgical generators in compliance with safety standards, IEC60601- 1, IEC60601-1-2 and IEC60601-2-2, including applicable national/regional differences. The instruments are compatible with monopolar electrosurgical generators of 2000V & 390kHz in cutting mode, 3500V & 390kHz in coagulating mode.

8. Recommended Maximum Diathermy Setting: Spatula: 30W, Cutting: 50W, Coag: 70W.

9. Do not embed the tip of electrode in the tissue for more than 10 seconds.

10. This instrument should be used with certified monopolar electrosurgical generators.

11. Keep the HF power output as low as possible to achieve the desired end effect. Refer to instructions for use provided by the manufacturer of electrosurgical generator to ensure that all safety precautions are followed.

12. Using a metal trocar sheath in conjunction with a plastic site stability device creates a potential hazard when using electrosurgical instruments.

13. Certain applications of the HF device can cause sparks. Follow the safety instructions in the HF device’s instructions for use very carefully.

14. Prior to switching on the HF device, make sure that the product’s working tip is not touching any accessory or fluid that conducts electricity. Keep the working tip in the user’s visual field whenever HF power is activated.

15. Do not put down the instrument on the patient or in the immediate vicinity of the patient.

Intended Use

This device is intended to be used in laparoscopic operation. Probe intends to grasp, manipulate, cut, and cauterize soft tissue and organs or take samples from the body of patient during the surgical procedures requiring the use of Monopolar electrosurgery.

Instructions for Use

1. Remove the instrument from the package.

2. Insert the instrument through the desired 3mm or 5mm trocar sheath. Please note the tip must be closed prior to insertion into or removal from the sheath.

Note: Please note the 3mm instruments should be used with 3mm trocars. Please use a converter for the insertion and removal of the 5mm forceps through a 10mm or 12mm trocar cannula. It may cause air leakage or desufflation of the abdominal cavity when using a 10mm or 12mm trocar cannula without an appropriate converter.

3. Use the handle to manipulate the tip of the forceps during the operation. If needed, activate the ratchet to secure the grasp of tissue.

Note: Keep the product contact surfaces clean during the operation. Wipe off dry tissue residues or body fluids with a damp swab.

Note: To avoid damage to the working tip: Handle the instrument with care. Insert the instrument carefully into the trocar. Do not exert excessive force on them and protect the working tip from hits and knocks.

4. The device is equipped with a standard 4mm male plug connector. To operate the monopolar electrosurgical feature, please follow instructions provided by the manufacturer of electrosurgical generator