KaVo PROPHYflex 4 Instructions For Use Manual

KaVo PROPHYflex 4 Instructions For Use Manual

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Instructions for use
PROPHYflex 4

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Summary of Contents for KaVo PROPHYflex 4

  • Page 1 Instructions for use PROPHYflex 4...
  • Page 2 Distributed by: Manufacturer: KaVo Dental GmbH Kaltenbach & Voigt GmbH Bismarckring 39 Bismarckring 39 D-88400 Biberach D-88400 Biberach Phone +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...
  • Page 3: Table Of Contents

    Instructions for use PROPHYflex 4 Table of contents Table of contents 1 User instructions ........................ 5 2 Safety..........................7 2.1 Infection hazard ......................7 2.2 Air embolism and skin emphysema.................. 7 2.3 Technical condition......................8 2.4 Accessories and combination with other equipment ............8 2.5 Qualification of personnel....................
  • Page 4 Instructions for use PROPHYflex 4 Table of contents 7.4.5 Automated drying ....................27 7.5 Care products and systems - Servicing................27 7.6 Packaging ........................27 7.7 Sterilisation........................28 7.8 Storage ........................28 8 Auxiliary equipment ......................29 9 Terms and conditions of warranty ..................31...
  • Page 5: User Instructions

    1 User instructions 1 User instructions Dear User Congratulations on purchasing this KaVo quality product. By following the in- structions below you will be able to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH KaVo Technical Service...
  • Page 6 Instructions for use PROPHYflex 4 1 User instructions Please note the electronic instructions for use Note: observe accompanying documents EAC conformity mark (Eurasian Conformity) GOST R certification Transportation and storage conditions (Temperature range) Transportation and storage conditions (Air pressure) Transportation and storage conditions...
  • Page 7: Safety

    Instructions for use PROPHYflex 4 2 Safety | 2.1 Infection hazard 2 Safety The instructions for use are a component of the product and must be read care- fully prior to use and be accessible at all times. The device may only be used in accordance with the intended use, any other type of use is not permitted.
  • Page 8: Technical Condition

    Instructions for use PROPHYflex 4 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. ▶ Check that the device is working properly and is in satisfactory condition before each use.
  • Page 9: Service And Repair

    ▶ Both patient and user have to wear protective goggles during the treat- ment. ▶ KaVo recommends the use of dust extraction equipment and mouth protec- tion during the treatment with PROPHYflex. 9 / 34...
  • Page 10: Product Description

    PROPHYflex 4 Wave (Mat. no. 3.002.8000) PROPHYflex 4 Lime (Mat. no. 3.002.8200) PROPHYflex 4 Flamingo (Mat. no. 3.002.8800) PROPHYflex 4 S Wave (Mat. no. 3.004.5900) PROPHYflex 4 S Lime (Mat. no. 3.004.5930) PROPHYflex 4 S Flamingo (Mat. no. 3.004.5950) 3.1 Purpose – Intended use...
  • Page 11: Technical Data

    Instructions for use PROPHYflex 4 3 Product description | 3.2 Technical data ▪ adhere to the specified intended use ▪ to protect him or herself, the patient and third parties from hazards, and ▪ to prevent contamination from the product 3.2 Technical data...
  • Page 12: Scope Of Delivery

    Instructions for use PROPHYflex 4 3 Product description | 3.3 Scope of delivery 3.3 Scope of delivery The set consists of: No./ Description Mat.No. Item no. 1 x ① PROPHYflex 4 with: Long gripping sleeve 3.003.0520 Cannula 3.003.1138 Powder container 3.002.8136...
  • Page 13: Transportation And Storage Conditions

    Instructions for use PROPHYflex 4 3 Product description | 3.4 Transportation and storage conditions 3.4 Transportation and storage conditions NOTICE Startup after refrigerated storage. Malfunction. ▶ Prior to startup, very cold products must be heated up to a temperature of 20 °C to 25 °C (68 °F to 77 °F).
  • Page 14: Start Up And Shut Down

    Instructions for use PROPHYflex 4 4 Start up and shut down | 4.1 Installing the MULTIflex coupling 4 Start up and shut down WARNING Hazard from non-sterile products. Infection hazard for dentist and patient. ▶ Before first use and after each use, prepare and sterilise the medical device and accessories appropriately.
  • Page 15: Operation

    ▶ Only use original KaVo powder. ▶ Reprocess and refill the powder container before each patient. ▶ Comply with the safety data sheets for KaVo powders. ▶ Safety data sheets are available for inspection at www.kavo.com, "Safety data sheets". 15 / 34...
  • Page 16 Instructions for use PROPHYflex 4 5 Operation | 5.3 Filling the powder container ▶ Unscrew the powder container anticlockwise. ▶ Before filling the powder container, shake the powder in the refilling bag well. ▶ Fill the powder container up to the marking.
  • Page 17: Mounting The Gripping Sleeve

    Instructions for use PROPHYflex 4 5 Operation | 5.4 Mounting the gripping sleeve 5.4 Mounting the gripping sleeve The gripping sleeve is available in two different lengths. ▪ Long gripping sleeve: 3.003.0520 ▪ Short gripping sleeve: 3.003.2607 ▶ Mount the ergonomically fitting gripping sleeve on the instrument without tilting it.
  • Page 18: Instructions For Use For Prophyflex Powder, Prophypearls®, Prophyflex Perio Powder

    Instructions for use PROPHYflex 4 5 Operation | 5.7 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder 5.7 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder ® PROPHYflex powder PROPHYpearls PROPHYflex Perio Powder When: When: When: ▪...
  • Page 19: Troubleshooting

    Instructions for use PROPHYflex 4 6 Troubleshooting | 6.1 Cleaning a blocked cannula 6 Troubleshooting Preventive measures ▶ After each treatment and before each sterilisation, unscrew the powder container in an anticlockwise direction and replace it with a clean powder container.
  • Page 20: Cleaning A Clogged Main Body

    Instructions for use PROPHYflex 4 6 Troubleshooting | 6.2 Cleaning a clogged main body 6.2 Cleaning a clogged main body ▶ Pulling off the grip sleeve with cannula. ▶ Unscrew the powder container anticlockwise. ▶ Push the nozzle needle through the aperture of the nozzle.
  • Page 21 Instructions for use PROPHYflex 4 6 Troubleshooting | 6.2 Cleaning a clogged main body ▶ Use the cleaning drill to clean or remove obstructions from the media tube from the front and the back. ▶ Tighten the nozzle with the wrench again.
  • Page 22: Reprocessing Steps In Accordance With Iso 17664

    Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparation at the site of use 7 Reprocessing steps in accordance with ISO 17664 7.1 Preparation at the site of use WARNING Hazard from contaminated products.
  • Page 23: Manual Internal Cleaning

    7 Reprocessing steps in accordance with ISO 17664 | 7.3 Manual Reprocessing 7.3.2 Manual internal cleaning Manual internal cleaning of the PROPHYflex 4 is not applicable. For effective re- processing, the inside of the device must be subjected to automated cleaning in a cleaning and disinfection unit in accordance with ISO 15883-1.
  • Page 24: Automated Reprocessing

    Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing 7.4 Automated reprocessing WARNING Incomplete disinfection. Infection hazard. ▶ Only use disinfection procedures that are verified to be bactericidal, fungi- cidal and virucidal.
  • Page 25: Overview Of The Reprocessing Options

    Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing 7.4.1 Overview of the reprocessing options Pre-clean- Automated Automated Automated Sterilisa- external internal internal tion cleaning cleaning and ex- ternal dis- infection Main body...
  • Page 26: Pre-Cleaning

    Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing 7.4.2 Pre-cleaning Accessories required: ▪ Tap water 30 C ± 2 C (86 F ± 4 ▪ Brush, e.g. medium-hard toothbrush ▶ Disassemble the instrument completely.
  • Page 27: Automated Internal And External Cleaning And Internal And External Disinfection

    Note Please observe the instructions for use of the thermodisinfector. ▶ In order to prevent impairment of the KaVo medical device, make sure that the inside and outside of the device is dry after the end of the cycle. 7.5 Care products and systems - Servicing NOTICE Improper care.
  • Page 28: Sterilisation

    Screw together the powder container and handpiece only in the cold state. The KaVo medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F). Select a suitable procedure (depending on the available autoclave) from the fol- lowing sterilisation processes: ▪...
  • Page 29: Auxiliary Equipment

    Instructions for use PROPHYflex 4 8 Auxiliary equipment 8 Auxiliary equipment Available from dental suppliers. Cannula Mat. no. 3.003.1138 Powder container Mat. no. 3.002.8136 Rubber cover supragingival Mat. no. 3.004.4708 Rubber cover subgingival Mat. no. 3.004.4709 Cleaning drill Mat. no. 0.573.0321 Nozzle pin Mat.
  • Page 30 Instructions for use PROPHYflex 4 8 Auxiliary equipment PROPHYflex Powder orange, Mat. no. 1.007.0014 Pack of 80 sticks PROPHYflex Powder, berry, Mat. no. 1.007.0015 Pack of 80 sticks PROPHYflex Powder, cherry Mat. no. 1.007.0016 Pack of 80 sticks PROPHYflex Powder, mint Mat.
  • Page 31: Terms And Conditions Of Warranty

    12 months from the date of the invoice, subject to the following conditions: In case of justified complaints, KaVo will honour its warranty with a free re- placement or repair. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded.

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