Description

The Insufflation Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Insufflation Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

Contraindications

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

Intended Use

1. Insufflation Needle is used with insufflation tubing to insufflate abdominal cavity in order to create working space for endoscopic procedure. The Insufflation Needle available in 120mm and 150mm lengths, has applications in gynaecological laparoscopy and other laparoscopic procedures.

2. The Insufflation Needle consists of stainless steel 14 gauge needle and spring loaded stylet that retracts backward while the needle is pushed through the abdominal tissue. The stylet then advances forward once the end of the needle exits through anterior wall of the abdomen. The Insufflation Needle has a stopcock with a luer lock connector for insufflation tubing attachment.

Instructions for Use:

1. Prior to insertion, inspect the Insufflation Needle to ensure that the stylet moving freely in and out of the needle with minimal pressure applied to the stylet. Do not attempt to use the Insufflation Needle if the stylet does not return over the sharp end when tension on the stylet is halted.

2. The Insufflation Needle is inserted into the abdomen per standard insertion technique.

3. Check to ensure that the Insufflation Needle is in the abdominal cavity and insufflate to desired pressure.

4. Once insufflation is complete and the desired abdominal pressure is accomplished, remove the Needle and proceed with procedure. Please follow instructions provided by the manufacturer of insufflator.

5. Upon completion of the endoscopic procedure, dispose of this device in accordance with local regulations.

Warnings and Precautions

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

• Procedures for endoscopic surgery should be performed only by qualified and trained physicians familiar with endoscopic surgical techniques.

• 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 sharps waste.