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Summary of Contents for KaVo SONICflex
- Page 1 Instructions for use SONICflex seal tips SONICflex seal tip no. 45 - 1.000.8323 SONICflex seal tip no. 45A - 1.007.1506...
- Page 2 Distribution: Manufacturer: KaVo Dental GmbH KaVo Dental GmbH Bismarckring 39 Bismarckring 39 88400 Biberach 88400 Biberach Germany Germany www.kavo.com Phone +49 7351 56-0 Fax +49 7351 56-1488...
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Page 3: Table Of Contents
4.1 Inserting the SONICflex tips ................... 11 4.2 Removing the SONICflex tip ................... 12 5 Operation........................... 13 5.1 Setting the power on the SONICflex ................13 5.2 Notes for application ...................... 13 6 Reprocessing steps in accordance with ISO 17664 ............14 6.1 Preparations at the site of use.................. -
Page 4: User Instructions
All other trademarks are property of their respective owners. KaVo Technical Service If you have any questions or complaints, please contact the KaVo Technical Service: +49 (0) 7351 56-1000 service.instrumente@kavokerr.com... - Page 5 Instructions for use SONICflex seal tips 1 User instructions Information on the packaging CE mark according to Medical Devices Directive EC 93/42 Note: Please note accompanying documents EAC conformity mark (Eurasian Conformity) Follow the electronic instructions for use GOST R certification...
- Page 6 Instructions for use SONICflex seal tips 1 User instructions Hazard levels The warning and safety notes in this document must be observed to prevent personal injury and material damage. The warning notes are designated as shown below: HAZARD In cases which – if not prevented – directly lead to death or severe injury.
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Page 7: Safety
Worn tips can fracture or be contaminated and thus cause injury or infection. 4 SONICflex tips need to be replaced every 9 to 12 months. 4 Have parts with sites of breakage or surface changes checked by the service personnel. -
Page 8: Accessories And Combination With Other Equipment
4 Do not make any modifications to the device unless these have been ap- proved by the manufacturer of the product. 4 Do not use SONICflex tips with products manufactured by third parties. 2.4 Qualification of personnel Application of the product by users without the appropriate medical training could injure the patients, the users or third parties. -
Page 9: Product Description
3 Product description 3.1 Intended use Indications for use: The SONICflex seal tip is designed for use in combination with the SONICflex for exposing and expanding fissures before sealing. Please refer also to the In- structions for Use. Proper use:... -
Page 10: Transportation And Storage Conditions
Instructions for use SONICflex seal tips 3 Product description | 3.4 Transportation and storage conditions The tip is identifiable by: ① 2-digit number and capital letter A 3.4 Transportation and storage conditions CAUTION Startup after refrigerated storage. Malfunction. 4 Prior to startup, strongly refrigerated products must be allowed to warm up to a temperature of 20 °C to 25 °C (68 °F to 77 °F). -
Page 11: Startup And Shut Down
4 When inserting the tip into the torque wrench, make sure that the end of the tip always faces the recess of the torque wrench. The torque wrench is used for changing the working tips of the SONICflex and for protection against injury. -
Page 12: Removing The Sonicflex Tip
Instructions for use SONICflex seal tips 4 Startup and shut down | 4.2 Removing the SONICflex tip 4.2 Removing the SONICflex tip 4 Place the torque wrench on the SONICflex tip and unscrew it in counter- clockwise direction. 12 / 20... -
Page 13: Operation
5.1 Setting the power on the SONICflex CAUTION Improper or excessive power setting. Tip fracture and malfunction. 4 It is essential to comply with the recommended settings for the KaVo SON- ICflex as shown in the table. LEVEL 1 = LEVEL 2 =... -
Page 14: Reprocessing Steps In Accordance With Iso 17664
NOTE If you use sterile coolant liquid, the SONICflex tips must be rinsed with spray water after each use in order to prevent crystallisation in the tips. 4 Reprocess the medical device as soon as possible after treatment. -
Page 15: Manual Internal Cleaning
4 Do not disinfect the device in the disinfection bath or with chloride-contain- ing disinfectants. KaVo recommends the following products based on the compatibility of the ma- terials. The microbiological efficacy must be ensured by the disinfectant manu- facturer and proven by an expert opinion. -
Page 16: Automated Reprocessing
1.009.7876 ① Service adaptor ② SONICflex tip 4 Use the wrench to screw the SONICflex tip ② onto the service adaptor ① in clockwise direction. 4 Pull the wrench off. 4 Plug the service adaptor ① onto the Miele adaptor (ADS). -
Page 17: Packaging
Instructions for use SONICflex seal tips 6 Reprocessing steps in accordance with ISO 17664 | 6.4 Packaging NOTE Please comply with the instructions for use of the washer disinfector. 6.4 Packaging NOTE The sterile goods package must be large enough to accommodate the product without stretching the packaging. -
Page 18: Consumables
Instructions for use SONICflex seal tips 7 Consumables 7 Consumables Available from dental suppliers. Material summary Material number Torque wrench 1.000.4887 Nozzle pin 0.410.0911 Service adaptor Material summary Material number Service adaptor SONICflex 2003 tips, 1.009.7875 long thread Service adaptor SONICflex quick tips, 1.009.7876...
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