Transcript
ACCU-Beam
TTIMedical
CO2 Laser Handpieces P/N 6103, 6104, 6105, 6108
______________________________ INSTRUCTIONS FOR USE ______________________________
Non-Sterile / Multiple Use Caution: Please read all instructions prior to use
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL 220 Porter Drive, Suite 120 Camino Ramon • San Ramon • CA 94582 USA Tel: 925-553-7828 • 800-322-7373 • Fax: 925-718-8225
Intended Use: The ACCU-Beam CO2 laser Handpieces are intended to be used with all articulated arm CO2 lasers. It is a surgical tool used primarily for tissue incision / coagulation / ablation. There are focal lengths of 75mm, 100mm, 125mm and 200mm available. Pathology and/or surgeons choice will dictate the choice of focal length. Refer to the user manual of the laser manufacturer for full clinical use information and cleared indications. Warnings: 1. Always, test fire the CO2 laser (with handpiece installed on the articulated arm) prior to surgery. 2. Never use if the CO2 beam does not strike the same spot as the HeNe target beam.
INSTRUCTIONS FOR USE: 1. Unscrew plastic dust cap from the proximal end of the handpiece. Thread the handpiece onto the laser articulated arm. Use a thread adaptor if required. 2. Attach the positive airflow tube to the port on the handpiece. Use standard 3mm ID / 69mm OD tubing.
3.
Activate the laser and place a moist tongue blade against the spacer tip of the handpiece. Set the laser power to the desired level and make several test burns. If the CO2 laser does not strike the same spot as the HeNe target beam, call the laser manufacturer to check beam alignment.
Optical Lens Assembly
Positive airflow port Body
Tube Open Tip
Cleaning and Sterilization: 1. Unthread the Optical Lens Assembly from the Handpiece. The optics cannot be subject to any form of sterilization.
2.
The Body, Tube and Open Tip can be cleaned with soap and water. A cleaning brush should be used to clean the interior of the Body, Tube and Open Tip. After cleaning it can be sterilized by autoclave, ETO or liquid sterilization.
Cleaning procedure: 2-1.
The Body, Tube and Open Tip must be cleaned immediately after use of charred tissue, blood and debris. Ultrasonic cleaning with non-corrosive solutions is recommended.
2-2.
Rinse thoroughly and dry. Use an air gun to remove liquids from the Body, Tube and Open Tip.
Sterilization: Steam Autoclave: Autoclave sterilization should be performed in accordance with the instructions provided by the manufacturer of the autoclave. Recommended settings for unwrapped Body, Tube and Open Tip are as follows: Cycle Sterilizing Temp. Sterilizing Time Drying Time Pre-vac 270ºF (132ºC) 4 min. 15 min. Gravity 270ºF (121ºC) 20 min. 15 min. Gravity 250ºF (121ºC) 30 min. 15 min. Ethylene Oxide Gas: ETO gas sterilization should be performed in accordance with the instructions provided by the manufacturer of the sterilizer. Cold-Soak Disinfection: The Body, Tube and Open Tip may be disinfected or sterilized with a disinfectant solution. Note:
Only EPA registered hard surface disinfectants capable of high-level disinfection should be used.
Cleaning procedure (continued): A.
Carefully follow the disinfectant manufacturer instructions.
B. C. D.
Use a plastic basin to avoid electrolyte corrosion. Rinse thoroughly, paying careful attention to remove solution from the Tube and Open Tip. Use a bulb aspirator or syringe as required. The Body Tube and Open Tip to be completely dry prior to reassembly and use.
3. Optics should be inspected after use and cleaned if necessary. Clean with lens paper or a soft cotton swab (without adhesive) dipped in reagent grade acetone and or lens cleaner. Optics should be cleaned in a circular motion from the center to the outside. Caution: Do not use alcohol or other cleaning agents on lenses. Do not autoclave or otherwise sterilize lenses.
TTI Medical Product Numbers: 6103 6104 6105 6108
F75mm Handpiece F100mm Handpiece F125mm Handpiece F200mm Handpiece
Authorized Representative per Medical Device Directive Actimed LTD Commer House, Tadcaster North Yorkshire LS24 9JF, UK
220 Porter Drive, Suite 120 • San Ramon, CA 94583 • USA Tel: (925) 553-7828 • (800) 322-7373 • Fax: (925) 718-8225 e-mail:
[email protected] • website: www.ttimedical.com
Rev 082115
