Related Manuals for KaVo SONICflex impant
Summary of Contents for KaVo SONICflex impant
- Page 1 Instructions for use SONICflex impant SONICflex implant set - 1.003.8167 SONICflex implant set A - 1.006.2027 SONICflex implant refill - 1.003.8168...
- Page 2 Distributed by: Manufacturer: KaVo Dental GmbH KaVo Dental GmbH Bismarckring 39 Bismarckring 39 88400 Biberach 88400 Biberach Germany Germany Phone +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...
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Page 3: Table Of Contents
Instructions for use SONICflex impant Table of contents Table of contents 1 User instructions....................... 2 Safety ..........................2.1 Infection hazard......................7 2.2 Technical condition......................7 2.3 Accessories and combination with other equipment ............8 2.4 Qualification of personnel....................8 2.5 Protective equipment ....................8 3 Product description...................... -
Page 4: User Instructions
SONICflex is a registered trademark of KaVo Dental GmbH. All other trademarks are property of their respective owners. KaVo Original Factory Repair In the event of a repair, please ship your product to the KaVo Original Factory Repair using www.kavobox.com. KaVo Technical Service... - Page 5 Instructions for use SONICflex impant 1 User instructions Original language German Information on the packaging Material number Production batch LOT T Manufacturer Note: Please note accompanying documents Follow the electronic instructions for use HIBC Code UDI symbol CE mark for medical devices...
- Page 6 Instructions for use SONICflex impant 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
4 Place the torque wrench on the tip when the handpiece is in its holder. 2.2 Technical condition A damaged product or damaged or NOT KaVo original components could injure patients, users or third parties. 4 Only operate devices or components if they show no signs of damage on the outside. -
Page 8: Accessories And Combination With Other Equipment
Working with sharp or pointed products can lead to injuries or infections. 4 Use a glove or finger guard when you test, insert and remove the tips. KaVo recommends always working with a rubber dam and a dust extraction system. -
Page 9: Product Description
Instructions for use SONICflex impant 3 Product description | 3.1 Intended use 3 Product description 3.1 Intended use Indications for use: This medical device is ▪ Intended for dental treatment only. All other types of use of or modifications to the product are not permitted and can be hazardous. -
Page 10: Identification Of Tip Type
Instructions for use SONICflex impant 3 Product description | 3.4 Identification of tip type 3.4 Identification of tip type Identification of tip type Tips without "A" can be used for: all versions of KaVo SONICflex 2003 KaVo SONICflex 2000 (Tips with long thread) Tips with "A"... -
Page 11: Startup And Shut Down
Dispose of and recycle the packaging appropriately in accordance with current packaging law, employing waste management / recycling companies. Comply with the comprehensive return system. KaVo has had its packaging licensed for this purpose. Please comply with the regional public waste-disposal system. -
Page 12: Inserting The Polymer Pin
Instructions for use SONICflex impant 4 Startup and shut down | 4.2 Inserting the polymer pin CAUTION Tip incorrectly inserted in the torque wrench. Danger of injury to the user. 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. -
Page 13: Removing The Polymer Pin
Instructions for use SONICflex impant 4 Startup and shut down | 4.3 Removing the polymer pin 4.3 Removing the polymer pin Do not reuse – single use only 4 Screw out the polymer pin anticlockwise by hand. 4.4 Removing the SONICflex tip 4 Place the torque wrench on the SONICflex tip and unscrew it in counter- clockwise direction. -
Page 14: 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 SONICflex as shown in the table. LEVEL 1 = LEVEL 2 =... -
Page 15: Reprocessing Steps In Accordance With Iso 17664-1 / Iso 17664-2
Malfunction and material damage. 4 Reprocess it in a washer disinfector only. 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: Manual Reprocessing
Instructions for use SONICflex impant 6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.2 Manual Reprocessing ▪ FD 322 made by Dürr Consumables required: ▪ Cloths for wiping the medical device. 4 Spray the disinfectant on a cloth, then wipe down the medical device and al- low the disinfectant to act according to the instructions of the disinfectant manufacturer. -
Page 17: Automated Internal And External Cleaning And Internal And External Disinfection
NOTE Please comply with the instructions for use of the washer disinfector. 4 In order not to affect the KaVo medical device, make sure that the product is dry on the inside and outside after completion of the cycle. 6.4 Care products and systems - Servicing Not applicable. -
Page 18: Packaging
Instructions for use SONICflex impant 6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.5 Packaging 6.5 Packaging NOTE The sterile goods package must be large enough to accommodate the product without stretching the packaging. The quality and use of the packaging of the... -
Page 19: Other Products
Instructions for use SONICflex impant 7 Other products 7 Other products Available from specialised dental dealers. Consumables Material summary Material number Torque wrench 1.000.4887 Nozzle needle 0.410.0911 SONICflex Implant refill 1.003.8168 Cleaning adapter Material summary Material number Cleaning adapter for SONICflex tips, 1.009.7875...
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