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Summary of Contents for KaVo SONICflex 2003
- Page 1 Instructions for use SONICflex 2003 – 1.000.4246 SONICflex LUX 2003 L – 1.000.4243...
- 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 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 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.................... -
Page 4: User Instructions
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 If you have any technical questions or complaints, please contact the KaVo... - Page 5 Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 1 User instructions Serial number Manufacturer Manufacturing date Note: Please note accompanying documents Follow the electronic instructions for use HIBC Code UDI symbol CE mark for medical devices...
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Page 6: Hazard Levels
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 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... -
Page 7: Safety
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 2 Safety | 2.1 Infection hazard 2 Safety NOTE All serious events occurring in relation to the product must be reported to the manufacturer and the competent authority of the member state, in which the user and/or patient resides. -
Page 8: Accessories And Combination With Other Equipment
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 2 Safety | 2.3 Accessories and combination with other equipment 4 If the following defects occur, stop working and have the service personnel carry out repair work: ▪... -
Page 9: Protective Equipment
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 2 Safety | 2.6 Protective equipment As a result of the use of NON-KaVo original spare parts during the repair, parts may become detached and injure patients, users or third parties. This may res- ult in aspiration, swallowing of parts and possibly even a risk of suffocation. -
Page 10: Description Of The Product
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 3 Description of the product | 3.1 Intended use 3 Description of the product 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 11: Technical Specifications
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 3 Description of the product | 3.3 Technical Specifications Recommendation for use of scaler and paro tips It is important to remove all the plaque to ensure satisfactory oral hygiene and thorough periodontological treatment. - Page 12 Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 3 Description of the product | 3.4 Transportation and storage conditions Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture (Keep dry)
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Page 13: Startup And Shut Down
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 4 Startup and shut down | 4.1 Installing the MULTIflex coupling 4 Startup and shut down WARNING Hazard from contaminated products. Patients, users or third parties could be infected by contaminated medical devices. -
Page 14: Checking The Pressures
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 4 Startup and shut down | 4.2 Checking the pressures 4.2 Checking the pressures CAUTION Damage from soiled and moist cooling air/compressed air. Contaminated and moist cooling air can cause malfunctions. -
Page 15: Operation
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 5 Operation | 5.1 Attaching the medical device 5 Operation 5.1 Attaching the medical device CAUTION Inexact coupling. Reduces the service life of the lamp. 4 Avoid inexact coupling. -
Page 16: Removing The Sonicflex Tip
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 5 Operation | 5.4 Removing the SONICflex tip 4 Use the thin region of the handle ① for insertion. 4 Use the thick region of the handle ② for tightening or detachment. - Page 17 Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 5 Operation | 5.5 Setting the power on the SONICflex 4 Set the power level on the control ring of the SONICflex. 17 / 28...
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Page 18: Reprocessing Steps In Accordance With Iso 17664-1 / Iso 17664-2
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.1 Preparations at the site of use 6 Reprocessing steps in accordance with ISO 17664-1 /... -
Page 19: Manual Reprocessing
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.2 Manual reprocessing 6.2 Manual reprocessing WARNING Incomplete disinfection. Patients, users or third parties could be infected by contaminated medical devices. -
Page 20: Manual Drying
6.2.3 Manual drying Use KaVo DRYspray for subsequent drying of the air, water and gear unit ducts. 4 Cover the medical device with the KaVo Cleanpac bag, and place it on the corresponding care adapter. 4 Hold the can vertically. -
Page 21: 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. 4 Remove any residual liquids with KaVoDRYspray. -
Page 22: Servicing Sonicflex With Kavo Spray
6.4.2 Servicing SONICflex with KaVo Spray 4 Remove the tip from the medical device. 4 Cover the medical device with the KaVo Cleanpac bag, and place it on the corresponding care adapter. 4 Press the spray key for 1 to 2 seconds. -
Page 23: Storage
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 6 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 6.7 Storage Sterilisation parameters: Select a suitable process from the following sterilisation processes (depending on the available steriliser): ▪... -
Page 24: Other Products
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 7 Other products 7 Other products Available from specialised dental dealers. Consumables Material summary Mat.No. INTRA Instrument stand 3.005.5204 Insert for SONICflex 3.005.3089 Cellulose pad 100 units 0.411.9862... -
Page 25: Terms And Conditions Of Warranty
Instructions for use SONICflex 2003 – 1.000.4246, SONICflex LUX 2003 L – 1.000.4243 8 Terms and conditions of warranty 8 Terms and conditions of warranty This KaVo medical device is subject to the following warranty conditions: KaVo grants the end customer a warranty of proper function and guarantees...
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