KaVo PROPHYflex 4 Perio Kit Instructions For Use Manual

KaVo PROPHYflex 4 Perio Kit Instructions For Use Manual

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Instructions for use
PROPHYflex 4 Perio Kit – 1.011.9403
Refill PROPHYflex perio tip – 1.010.0287

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Summary of Contents for KaVo PROPHYflex 4 Perio Kit

  • Page 1 Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287...
  • 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...
  • Page 3: Table Of Contents

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 Table of contents Table of contents 1 User instructions ........................ 4 2 Safety..........................7 2.1 Infection hazard ......................7 2.2 Air embolism and skin emphysema ................. 7 2.3 Technical condition ......................
  • Page 4: User Instructions

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 1 User instructions 1 User instructions Dear User Congratulations on purchasing this KaVo quality product. By following the notes below you will be able to work smoothly, economically and safely.
  • Page 5 Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 1 User instructions Thermodisinfectable Information on the packaging Material number Serial number Manufacturer Note: Please note accompanying documents Follow the electronic instructions for use HIBC Code...
  • Page 6 Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 1 User instructions CAUTION In cases which – if not prevented – can lead to minor or moderate in- jury. NOTICE In cases which – if not prevented – can lead to material damage.
  • Page 7: Safety

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 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: Technical Condition

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 2 Safety | 2.3 Technical condition 2.3 Technical condition A damaged device or components could injure patients, users and third parties. ▶ Only operate devices or components if they are undamaged on the outside.
  • Page 9: Product Description

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 3 Product Description | 3.1 Intended use 3 Product Description PROPHYflex 4 perio Kit - REF 1.011.9403 Index ① 3x perio tip ② 1x Adapter ③...
  • Page 10: Transportation And Storage Conditions

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 3 Product Description | 3.2 Transportation and storage conditions Proper use: According to these regulations, this product may only be used for the described application by a properly trained user. You need to comply with the following: ▪...
  • Page 11: Startup And Shut Down

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 4 Startup and shut down | 4.1 Inserting the adaptor into the PROPHYflex 4 Startup and shut down WARNING Hazard from contaminated products. Infection hazard for care provider and patient.
  • Page 12: Screwing The Prophyflex Perio Tip Onto The Adaptor Using The Wrench

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 4 Startup and shut down | 4.3 Screwing the PROPHYflex perio tip onto the adaptor using the wrench 4.3 Screwing the PROPHYflex perio tip onto the adaptor...
  • Page 13 Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 4 Startup and shut down | 4.4 Removing the PROPHYflex perio tip ▶ Carefully pull the PROPHYflex perio tip out of the wrench. Take the adapter off ▶...
  • Page 14: Operation

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 5 Operation 5 Operation Preparation CAUTION Risk of increased development of emphysema. If the pressure is too high during the treatment, there is an increased risk of emphysema developing.
  • Page 15 Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 5 Operation Treating the patient CAUTION Hazard from overly frequent use or dropping of the handpiece. The PROPHYflex perio tip can fracture or be contaminated.
  • Page 16: Reprocessing Steps In Accordance With Iso 17664

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 6 Reprocessing steps in accordance with ISO 17664 | 6.1 Preparations at the site of use 6 Reprocessing steps in accordance with ISO 17664 Note The reprocessing procedures described in the following apply to the PROPHYflex perio tip, adaptor and wrench.
  • Page 17: Manual Reprocessing

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 6 Reprocessing steps in accordance with ISO 17664 | 6.3 Manual Reprocessing 6.3 Manual Reprocessing WARNING Sharp tool in the medical device. Injury hazard from sharp and/or pointed tool.
  • Page 18: Manual Disinfection - Internal

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 6 Reprocessing steps in accordance with ISO 17664 | 6.4 Automated reprocessing Consumables required: ▪ Cloths for wiping the medical device. ▶ Spray the disinfectant on a cloth, then wipe down the medical device and allow the disinfectant to act according to the instructions of the disinfectant manufacturer.
  • Page 19: Preparation For Automated Internal And External Cleaning As Well As Internal And External Disinfection

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 6 Reprocessing steps in accordance with ISO 17664 | 6.4 Automated reprocessing 6.4.1 Preparation for automated internal and external cleaning as well as internal and external disinfection Note For reprocessing, attach the PROPHYflex perio tip ③...
  • Page 20: Visual Inspection And Functional Check

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 6 Reprocessing steps in accordance with ISO 17664 | 6.5 Visual inspection and functional check 6.5 Visual inspection and functional check Note Plug the adaptor with the PROPHYflex perio tip onto the PROPHYflex with an empty powder container, and check it.
  • Page 21: Storage

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 6 Reprocessing steps in accordance with ISO 17664 | 6.9 Storage ▶ Use according to the manufacturer's Instructions for Use. 6.9 Storage Prepared products must be stored appropriately in a dry, dark, cool room such that they are protected from germs (as far as possible) and dust.
  • Page 22: Tools

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 7 Tools 7 Tools Available from specialised dental dealers. Adapter perio tip 1.011.9400 2.000.0901 Wrench for cannula 3.004.6351 Nozzle pin 0.410.0911 PROPHYflex perio tip Refill 1.010.0287...
  • Page 23: Terms And Conditions Of Warranty

    Instructions for use PROPHYflex 4 Perio Kit – 1.011.9403 Refill PROPHYflex perio tip – 1.010.0287 8 Terms and conditions of warranty 8 Terms and conditions of warranty The following warranty conditions apply to this KaVo medical device: KaVo provides the end customer with a warranty of proper function and guar-...

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Prophyflex perio tip1.011.94031.010.0287

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