DENTSPLY Cavitron Manual

DENTSPLY®CAVITRON®ULTRASONIC INSERTS
DIRECTIONS FOR USE and INFECTION CONTROL PROCEDURES
INSERTS ULTRASONIQUES DENTSPLY®CAVITRON®
MODE D’EMPLOI et PROCÉDURES DE CONTRÔLE DE L’INFECTION
INSERTOS ULTRASÓNICOS DENTSPLY®CAVITRON®
INSTRUCCIONES DE USO y PROCEDIMIENTOS PARA EL CONTROL DE INFECCIONES
INSERTI ULTRASONICI DENTSPLY® CAVITRON®
ISTRUZIONI PER L'USO e PROCEDURE DI CONTROLLO DELLE INFEZIONI
DENTSPLY®CAVITRON®
ULTRASCHALL-INSTRUMENTENEINSÄTZE
GEBRAUCHSANLEITUNG und INFEKTIONSKONTROLLVERFAHREN
Cavitron
УЛЬТРАЗВУКОВЫЕ ВКЛАДЫШИ DENTSPLY®CAVITRON®
УКАЗАНИЯ ПО ПРИМЕНЕНИЮ и ПРОЦЕДУРЫ ПРОФИЛАКТИКИ ИНФЕКЦИЙ

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DIRECTIONS FOR USE
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INDICATIONS FOR USE
Cavitron®inserts are to be used with magnetostrictive
ultrasonic scalers to perform:
• All general supra and subgingival scaling applications.• Periodontal debridement for all types of periodontal diseases.• Endodontic Procedures.CONTRAINDICATIONS
• Cavitron inserts should not be used for restorative dental procedures involving condensation of amalgam.WARNING
• Tips with high usage which exceed the warranty period
should be discarded to avoid possible in-use breakage and
possible injury.• Handle insert with care. Improper handling of insert, specifically the insert tip, may result in injury and/or cross contamination.• It is strongly recommended that this insert be used in accordance with the current CDC Guidelines for Infection Control in dental healthcare settings.• Failure to follow properly validated sterilization processes and approved aseptic techniques for Cavitron inserts may result in cross contamination.PRECAUTIONS
• It is the responsibilty of the Dental Healthcare Professional to determine the approriate uses of this product and to
understand:
• The health of each patient; • The dental procedures being undertaken; • The applicable industry and government agency recommendations for the infection control in dental

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healthcare settings; • The requirements, and regulations for the safe practice of dentistry, and;  These Directions For Use in their entirety.• Operate the inserts only at the recommended power
settings.
• Check water spray to verify fluid is reaching the working end of the insert tip. Adjust the water lavage control until the water (lavage) flows with a rapid drip or small spray (approximately 35mL). Higher water flow settings provide cooler irrigation.• Do not bend or reshape insert. Inserts should be handled
with care at all times. Ultrasonic Inserts tips that have been bent, reshaped or otherwise damaged are susceptible to in-use breakage and should be discarded and replaced
immediately.• Cavitron ultrasonic scaling units and Cavitron ultrasonic inserts are designed and tested for safety and efficacy as a system. Use of any other brand ultrasonic equipment with Cavitron equipment has not been tested and may have a negative effect on the safety and effectiveness of your Cavitron equipment and their warranties. Please review the warranty statement enclosed before use.• Like bristles of a toothbrush, ultrasonic inserts “wear” with use. Refer to the Efficiency Wear Indicators supplied with your Cavitron system or insert and the How to Use the Efficiency Indicator section of these Directions for Use. If excessive wear is noted, discard the insert immediately.ADVERSE REACTIONS: None Known.UNIT POWER SETTINGS
• PEC, PEC-2, Focused Spray® Slimline®-10S, L&R and Slimline®-10S, L&R inserts should only be used up to medium power.• All other Cavitron inserts may be used up to maximum power.

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INSERT SELECTION
Base insert selection on the following:
• Patient’s health or disease status.• Root anatomy, considering concavities and furcations.• Type and location of deposits to be removed.For Gross Deposit Removal
Classic P, TFI®, and Focused Spray® Powerline™ InsertsFor Fine Definitive Debridement
Focused Spray Slimline® and Slimline®straight inserts and
Cavitron THINsert®for light calculus removal and deplaquing
pockets <4 mm deep. Focused Spray Slimline and Slimline®left and right inserts for
fine periodontal debridement, excellent access and adaptation to root anatomy in pockets >4 mm deep.For Endodontic Procedures
PEC and PEC2 Endosonic® Inserts used with DENTSPLY Professional Endosonic Files for root canal therapy. OPERATING INSTRUCTIONS
1. Select the appropriate insert for the tooth or root to be treated.2. Use the lowest effective power setting.3. Adjust the water control until the water (lavage) flows with a rapid drip or small spray.4. Use very light pressure with a light pen or modified pen grasp.5. Use a light but stable intraoral or extraoral fulcrum.6. Adapt the insert so the point is not directed into root surface.

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7. Use a light, smooth gentle touch.8. Keep the insert tip in motion at all times, using overlapping horizontal, vertical or oblique brush-like strokes.9. Use the inactivated insert to explore/evaluate root surface.O-RING CARE
Before placing the insert into the handpiece, performing the following steps will increase the o-ring life on Cavitron inserts:
• Fill entire handpiece with water.• Lubricate o-ring (black or green rubber material) with water.• Gently twist the insert down into the handpiece until the insert is fully seated in place.WARNINGS
• Instruments are not sterile upon receipt and must be sterilized
prior to use in accordance with the following instructions. • The use of cleaning and disinfectant solutions is not
recommended.LIMITATIONS ON PROCESSING
• Repeated cleaning and sterilization cycles have minimum
effect on these instruments. End of life is normally determined
by wear and damage due to use.• Do not use chemical disinfectants prior to sterilization or rapid
deterioration of the material may occur.• Cold liquid disinfection/sterilization, chemical vapor
sterilization, and dry heat sterilization methods have not been
tested or validated for efficacy and are not recommended for
use.INSTRUCTIONS
Point of use:
Remove excess soil with disposable cloth or paper.Containment and Transportation:
Protect instruments from damage. Instruments should be reprocessed as soon as is reasonably practical following use. Instruments left standing wet may stain or corrode.INFECTION CONTROL PROCEDURES

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Cleaning: Automated
• May be cleaned using an ultrasonic water bath for
15 minutes.
Cleaning: Manual
• Rinse all instruments under running water to remove any
gross debris.Disinfection:
Additional disinfection is not necessary prior to sterilization.Packaging:
Place instrument in a paper or paper/plastic steam sterilization pouch. Instruments may be loaded into dedicated instrument trays. Remove Endosonic Files from PEC and PEC2 inserts prior to packaging.Sterilization:
Use a steam autoclave. Place bagged instruments into the steam autoclave, paper side up when using a paper/plastic pouch. Gravity Steam SterilizationFull Cycle: Bagged -135°C (275°F) for 3.5 minutes
Pre-vacuum Steam SterilizationFull Cycle: Bagged -132°C (270°F) for 3 minutes Alternate Method:Place non-bagged instruments into the steam autoclave and run at the listed cycles.
NOTE: Instruments sterilized unbagged should be used immediately.Drying:
To dry, use the drying cycle of the autoclave. Set cycle for
20-30 minutes.Maintenance, inspection and testing:
• Visually inspect to ensure all contamination is removed.
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• Visually inspect all o-rings for wear. Replace worn o-rings
(Refer to O-Ring Replacement Kit Instructions). Lubricate o-rings with water before use.• Check for distortion, damage and wear (Refer to Efficiency Wear Indicator Instructions). Discard damaged, worn or
corroded instruments. Storage:
To maintain sterility, instruments should remain bagged until ready for use.1) For cards with notches, place the insert tip flat against the applicable Insert Tip diagram with the engraved line aligned with the edge of the card. For cards without notches, match the insert to the appropriate graphic. Hold the top of the grip flush against the edge of the wear guide. Rotate the insert so the tip is flat against the card.2) Compare length to the red and blue lines.3) Evaluate tip shape. If shape does not match profile, discard the insert.To re-order Inserts, call your local DENTSPLY Professional Distributor or call Customer Service 800-989-8826To order efficiency indicator cards for Cavitron®inserts: Call
DENTSPLY Professional Customer Service at 1-800-989-8826.Cavitron® ultrasonic inserts manufactured by DENTSPLY Professional are warranted against defects arising from faulty
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HOW TO USE THE EFFICIENCY WEAR INDICATOR
Tip touches
blue line
Reorder
Tip touches
red line
Discard
Tip extends beyond
blue line
Optimal Efficiency
Red Blue
WARRANTY

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materials or workmanship for ninety days from the date of purchase. This warranty extends to inserts purchased from an authorized DENTSPLY distributor and only to the original purchaser and is valid only for inserts purchased in the United States (U.S.) and for those countries without specific warranty requirements. For inserts purchased outside the U.S. in countries with specific warranty requirements, those applicable country warranties will apply. This warranty is subject to the following conditions:
1) Inserts must not be subjected to abuse or improper use or
application.2) Inserts must not be subjected to abuse or improper cleaning,
disinfection, or sterilization procedures.3) Bending or reshaping the inserts will void the warranty.4) Using inserts in units other than CAVITRON ultrasonic systems will void the warranty. There are no warranties, expressed or implied beyond the description on the face hereof. DENTSPLY neither assumes, nor authorizes any person to assume for it, any other liability for incidental and consequential damages resulting from the use
of the insert.To receive reimbursement for any defective Cavitron ultrasonic insert, you must send the defective product within the warranty period to the dealer or manufacturer with specification of the
defect and receipt of purchase.FOR TECHNICAL SUPPORT:
Call DENTSPLY PROFESSIONAL PRODUCT SERVICES
DEPARTMENT at 1-800-989-8826.

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MODE D'EMPLOI
INDICATIONS
Les inserts Cavitron®doivent être utilisés avec des détartreurs
ultrasoniques magnétostrictifs afin d’effectuer les procédures suivantes:
• Toutes les procédures générales de détartrage sus- et
sous-gingival.• Débridement parodontal pour tous les types de maladies
parodontales.• Les procédures endodontiques.CONTRE-INDICATIONS
Les inserts Cavitron ne doivent pas être utilisés pour des procédures de restauration dentaire nécessitant la
condensation d’un amalgame.AVERTISSEMENT
• Les embouts fortement usagés et dont la période de garan-
tie a expiré doivent être jetés afin d’éviter leur éventuelle cassure en cours d’utilisation et des blessures potentielles.• Manipuler l’insert avec soin. Une mauvaise manipulation de l’insert, en particulier de l’embout, risque de provoquer des blessures et/ou une contamination croisée.• Il est fortement recommandé d’utiliser cet insert conformé-
ment aux directives du CDC (“Center for Disease Control”, ou Centre américain de veille sanitaire) relatives au contrôle
des infections en cabinet dentaire.• Tout manquement aux procédures de stérilisation validées et aux techniques d’aseptisation homologuées pour les inserts Cavitron risque de provoquer une contamination
croisée.

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PRÉCAUTIONS
• Il est de la responsabilité du praticien dentaire de déterminerles cas dans lesquels ce produit peut être utilisé, et d’être au fait de :
• l’état de santé du patient ;• les procédures de soins dentaires actuellement entreprises;• les recommandations professionnelles et officielles en matière de contrôle des infections dans le cadre des soins
dentaires ;• es exigences et la réglementation nécessaires à une pratique sans danger de sa profession ; et• le présent Mode d’emploi dans son intégralité.• Vaporiser un peu d’eau pour s’assurer que le liquide atteint l’extrémité de l’embout de l’insert. Régler le débit de lavage jusqu’à ce que l’eau (de lavage) s’égoutte rapidement ou s’écoule en un mince jet (environ 35 mL). Un débit d’eau plus important entraîne une irrigation plus froide.• Ne pas tordre et ne pas déformer l’insert. Prendre garde à toujours le manipuler avec soin. Les pointes d’insert ultrasonique qui ont été tordues, endommagées ou déformées sont susceptibles de se casser en cours
d’utilisation et doivent être jetées et remplacées immédiatement.• Les unités de détartrage à ultra-sons Cavitron et les inserts Cavitron sont conçus et testés pour une utilisation
sans danger et un fonctionnement efficace du système. L’utilisation d’un dispositif à ultra-sons d’une autre marque avec le matériel Cavitron n’a pas été testée, des effets néfastes sont donc possibles pour la sécurité et l’efficacité du système Cavitron, ainsi que pour les garanties. Veuillez lire attentivement la déclaration de garantie ci-jointe avant
toute utilisation.
 Tout comme les poils d’une brosse à dents, les pointes d’insert ultrasonique s’émoussent avec l’usage. Utilisez