Cleaning And Sterilization Procedures; Procedural Recomendations - Ultradent Gemini EVO 810 Bedienungsanleitung

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CLEANING AND STERILIZATION PROCEDURES

GUIDELINES
The Gemini EVO 810+980 soft tissue 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, 3 mm, and 7 mm PBM adapters are also provided non-sterile by the manufacturer and should be cleaned and sterilized prior to initial use and after each use following these
instructions:
HANDPIECE CLEANING
Warning: The Gemini EVO 810+980 soft tissue laser or any of 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. Same procedure applies for 3 mm and 7 mm PBM adapters. PBM adapters must be removed from handpiece prior to cleaning.
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®.
HANDPIECE 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: 17.1)
1. Place the handpiece shell, 3 mm and/or 7 mm PBM adapters in a separate single-wrap, self-seal autoclave pouch.
2. Place on an autoclave tray with paper side down; 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 10 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, 3 mm and/or 7 mm PBM adapters must remain in the sterilization pouch until used in order to
maintain sterility.
5. Visually inspect handpiece shell or 3mm/7mm PBM adapter to ensure product is not degraded. Below are the criteria for the degradation for the respective items:
A visual and mechanical inspection of the PBM adapters and aluminum handpiece after each sterilization should be conducted to ensure adapters have not degraded and lost performance.
Unacceptable deterioration includes cracked glass (Figure: 16.1), delamination of anodized material (Figure: 16.2), a non-circular spot when checking the aiming light on a flat surface (Figure: 16.3)
and not being able to fully thread onto the handpiece. In the event the adapters have cracked glass or a non-circular aiming light spot, please send the adapters back to the manufacturer for review.
6. Remove / reassemble the handpiece shell or 3mm/7mm PBM adapter following the instructions below.
• 7mm PBM Tip turn counter clockwise to remove it. (Figure: 17.1, Option: 1)
• 3mm PBM Tip turn counter clockwise to remove it. (Figure: 17.1, Option: 2)
• Turn aluminum handpice shell counter-clockwise to be removed. (Figure: 17.1, Option: 3)
• Remove aluminum handpiece shell for cleaning and sterilization. (Figure: 17.1, Option: 4)
• Extreme care is needed not to accidentally damage LED lens. (Figure: 17.1, Option: 5)
• Clean from these threads down the fiber optic cable. (Figure: 17.1, Option: 6)
• To reassemble, slide the handpiece shell onto the handpiece body and turn clockwise to tighten.
NOTE: The exterior of the laser unit is not routinely contaminated by procedures. The Guided Touch Interface and Electroluminescent display should be covered with a protective clear adhesive barrier film,
replaceable after each patient. If the exterior of the laser unit should become contaminated, it should be wiped down with CaviWipes®, or equivalent product, then re-covered with a new protective plastic
cover. We recommend wringing out any cleaning wipes before use to avoid dripping liquid on the laser unit.
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.
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