Bovie LSE-01 Laparoscopic Smoke Evacuator Instruction Manual
- June 9, 2024
- Bovie
Table of Contents
Bovie LSE-01 Laparoscopic Smoke Evacuator
INDICATIONS FOR USE/CLINICAL BENEFITS
The Laparoscopic Smoke Evacuator is a single-use, sterile device used to capture and filter diathermy smoke generated during closed surgical procedures such as endoscopy or laparoscopy. The device captures & filters particulate cells, certain bacteria, viruses, and odor-causing chemicals from surgical diathermy smoke to provide a smoke-free vision to surgeons while maintaining pneumoperitoneum during minimally invasive surgeries (laparoscopic).
CONTRAINDICATIONS
The device is not intended for use except as indicated, and when laparoscopic procedures are contraindicated.
CAUTIONS/WARNINGS
- Inspect the package prior to use. DO NOT use if the sterile packaging is opened, damaged, or wet.
- The device is for single-patient use only. Re-use or re-processing may lead to devise failure and subsequent patient injury.
- DO NOT re-sterilize the device. Re-sterilization may compromise device integrity and create the risk of contamination and unintended patient infection.
- Extended use of smoke filtration, when connected to a trocar, may cause a reduction in pneumoperitoneum.
- DO NOT use past the expiry date. The device’s sterility may be compromised if used past the expiry date.
- The device is sterile if the package is dry, unopened, and undamaged. DO NOT use if the pouch is damaged or the packaged seal is broken.
INSTRUCTIONS FOR USE
Read and become familiar with the instructions for use and cautions/warnings before using the device (Figure 1.). You should have a thorough understanding of the principles and techniques of smoke evacuation and surgical laparoscopy before using the product.
- Remove the Laparoscopic Smoke Evacuator from its sterile packaging. Inspect the device for damage and discard if any damage is noted. Otherwise, place it on a sterile field.
- Attach and tighten the lower connector (1) of the tube to the stopcock on a trocar. Connect to the largest trocar that is closest to the smoke source.
- Secure the device to the surgical drape using the drape clamp (3) such that the filter housing (5) is away from the operative site. For best performance, the device should be positioned elevated above the trocar.
- The side port of the trocar should be fully opened before smoke is created. Rotate the wheel of the roller clamp (2) to adjust air flow rate. Rotating towards the trocar increases the flow rate. Rotating towards the filter decreases the flow rate.
- Upon completion of the procedure, the Laparoscopic Smoke Evacuator should be discarded in biohazardous waste in accordance with applicable federal, state, and local medical or hazardous waste guidelines.
Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is.
- Luer Lock
- Roller Clamp
- Drape Clamp
- PVC Tube
- Filter Housing
Safety Instruction
- The product conforms with the requirements of European Medical Device Regulation 2017/745.
- Caution, consult accompanying documents.
- Do not re-sterilize.
- Keep away from sunlight.
- Keep dry.
- Method of sterilization using ethylene oxide.
- Single sterile barrier system with protective packaging outside.
- Use-by date.
- Caution: US Federal Law restricts this device to sale by or on the order of a physician.
- Single sterile barrier system with protective packaging inside.
- Do not use it if the package is damaged.
- Consult Instructions for Use.
- Not made with natural rubber latex.
- Do not reuse.
- Medical Device.
- Trademark protected.
Distributed exclusively in the USA by Symmetry Surgical, 3034 Owen Drive, Antioch, TN 37013, USA Email: [email protected], Telephone: USA & CANADA +1 800-251-3000 (Monday-Friday, 7:00 AM – 5:30 PM CST).
The O R Company Pty Ltd, 4/47 Wangara Road, Cheltenham, Victoria 3192,
Australia. www.theorcompany.com.
OBELIS SA, Bd Général Wahis 53, 1030 Brussels, BELGIUM, Tel: +(32) 2 7325954.