Cleaning And Sterilization Procedures; Procedural Recomendations - Gemini 810 DIODE LASER Manual Del Usuario

CLEANING AND STERILIZATION PROCEDURES

GUIDELINES
The Gemini 810 + 980 diode laser is not supplied in sterile condition, nor must it be sterilized before use with the exception of the handpiece. The following cleaning and sterilization procedures are
recommended before the initial use and after each subsequent use:
1. The disposable fiber tips are supplied non-sterile by the manufacturer and should be wiped with Isopropyl alcohol wipes by the operator prior to use. The tips are to be discarded in an infectious
waste container (SHARPS) after each use. There is no re-use or re-processing procedure indicated for the disposable fiber tips.
2. The aluminum handpiece is also provided non-sterile by the manufacturer and should be cleaned and sterilized prior to initial use and after each use following these instructions:
CLEANING
Warning: The Gemini 810 + 980 diode laser and its components cannot be cleaned with an automated cleaning process.
The cleaning process is intended to remove blood, protein, and other potential contaminants from the surfaces and crevices of reusable accessories. This process may also reduce the quantity of
particles, microorganisms, and pathogens present. Cleaning must be performed within a maximum of 1 hour after the procedure and always prior to sterilization:
1. After use, carefully remove the disposable fiber tip from the handpiece and dispose of in an infectious waste container (SHARPS).
2. Clean the handpiece and attached fiber cable by using one CaviWipes® towelette, or equivalent product, to completely pre-clean exposed areas of all gross debris. Be sure to wipe the threaded
area where the disposable tip attaches.
3. Remove the handpiece shell following the instructions on the next page. Use a fresh towelette to pre-clean the newly exposed handpiece shell thread and the end cap (starting at the o-ring and
wiping towards the fiber cable).
4. Use a new towelette to thoroughly wet all pre-cleaned areas, keeping all areas wet for 2 minutes at room temperature (68° F/20° C). Repeated use of towelettes may be required to ensure that the
surfaces remain visibly wet.
5. Visually inspect the handpiece to ensure there is no visible debris remaining. If necessary, continue wiping with CaviWipes until all visible debris is removed.
6. Wipe all exposed areas of the handpiece with isopropyl alcohol wipes to remove any residue left by the CaviWipes®.
STEAM STERILIZATION
The steam sterilization process is intended to destroy infectious microorganisms and pathogens. Always perform the sterilization procedure immediately after cleaning and prior to use, and only use
FDA-cleared (USA) or CE-marked (Europe) sterilization accessories such as sterilization pouches and autoclave trays. (Figure: 6.1)
1. Place the handpiece shell in a separate single-wrap, self-seal autoclave pouch.
2. Place on an autoclave tray with paper side up; do not stack other instruments on top of the pouch.
3. Place the tray inside the autoclave chamber and set the cycle to 135° C (275° F) for a minimum of 15 minutes, with a dry time of 30 minutes.
4. Once the cycle is completed, remove the tray and let the sterilized item cool and dry. The handpiece must remain in the sterilization pouch until used in order to maintain sterility.
5. Reassemble the handpiece following the instructions below. (Figure 6.1)
1. Turn aluminum hand pice shell counter-clockwise to be removed. (Figure: 6.1, Option: 1)
2. Remove aluminum hand piece shell for cleaning and sterilization. (Figure: 6.1, Option: 2)
3. Extreme care needed not to accidentally damage LED lens. (Figure: 6.1, Option: 3)
NOTE: The exterior of the laser unit is not routinely contaminated by procedures. The keypad and electroluminescent display should be covered with a protective clear adhesive barrier film, replaceable
after each patient. If the exterior of the laser unit becomes contaminated, it should be wiped down with CaviWipes®, or equivalent product, then re-covered with a new protective plastic cover.
DO NOT spray any disinfectant directly on the laser unit, because it could damage the transparent electroluminescent display.
DO NOT use abrasive materials to clean the laser or the display.
Never point the Laser tip directly at the face, eyes or skin of anyone while emitting energy.
PROCEDURAL RECOMMENDATIONS
GUIDELINES
The following procedure guidelines are provided as a guide only and have been developed based on information provided by experienced laser users and educators. Always review the patient's history
to evaluate possible contra-indication for use of local anesthesia or other complications.
All clinical procedures performed with the Gemini 810 + 980 diode laser must be subjected to the same clinical judgment and care as with traditional techniques and instruments. Patient risk must
always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment.
INDICATIONS FOR USE
The particular and specific intended use of the Gemini 810+980 Diode Laser is to remove, ablate and coagulate tissue, mainly used for dental surgical procedures and is marketed as a dental soft tissue
surgical product. The main intended users for this particular device are general dentists, oral surgeons, orthodontists performing procedures where tissue needs to be removed, ablated or coagulated.
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