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. This device is not intended for contraceptive coagulation on fallopian tissue. It may be used to achieve hemostasis following transaction of the fallopian tube.

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 crossinfection 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 utilizing endoscopic instruments and accessories supplied from different manufacturers, verify compatibility and ensure that electrical isolation of grounding is not compromised.

4. A thorough understanding of techniques and principals involved in electrosurgical procedures are necessary to avoid burn or shock hazards 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

1. The Laparoscopic Instruments are intended for use in general and gynaecologic endoscopic procedures for transection, dissection, and coagulation of tissue.

2. The disposal Hook or Spatula electrode is a sterile and single-use instrument to be used in a variety of laparoscopic procedures to coagulate, transect, mobilize and dissect tissue.

Instructions for Use

1. Remove the probe from the package.

2. For hand-controlled probe, connect it with the electrosurgical pencil.

3. Insert the sleeve through the desired 5mm trocar sheath. Note: Please use a converter for the insertion and removal of the 5mm probes 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. Note: Keep the product contact surfaces clean during the operation. Wipe off dry tissue residues or body fluids with a damp swab.

4. The foot-controlled probe is equipped with a standard 4mm male plug connector. To operate the monopolar feature, please follow instructions provided by the manufacturer of electrosurgical generator. For hand-controlled version, to operate the monopolar feature, please follow the instructions provided by the manufacturer of electrosurgical pencil and electrosurgical generator.

5. Some models come with a 4mm monopolar connecting cable. To connect the probes with the electrosurgical generator, simply connect the cable to the 4mm male plug connector and the distal end to the electrosurgical generator.