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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 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 Table of contents Table of contents 1 User instructions....................... 2 Safety ..........................2.1 Infection hazard......................8 2.2 Air embolism and skin emphysema................. 8 2.3 Technical condition......................8 2.4 Accessories and combination with other equipment ............9 2.5 Qualification of personnel....................
  • Page 4 Instructions for use PROPHYflex 4 Table of contents 8 Consumables........................32 9 Terms and conditions of warranty ..................35 4 / 36...
  • Page 5: 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 6: Hazard Levels

    Instructions for use PROPHYflex 4 1 User instructions Serial number Unique Device Identifier Manufacturer Note: Please note accompanying documents Follow the electronic instructions for use HIBC Code CE mark for medical devices Authorized representative in Switzerland EAC conformity mark (Eurasian Conformity) UA Mark of conformity UA.TR.099...
  • Page 7 Instructions for use PROPHYflex 4 1 User instructions WARNING In cases which – if not prevented – can lead to death or severe injury. CAUTION In cases which – if not prevented – can lead to minor or moderate injury.
  • Page 8: Safety

    PROPHYflex is in the holder. 2.3 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 9: Accessories And Combination With Other Equipment

    Define the service interval depending on the frequency of use. 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: Protective Equipment

    2 Safety | 2.8 Protective equipment NOTE If a repair is done with NON-KaVo original spare parts, this may constitute a device modification that leads to the loss of CE conformity. In the event of damage, the company performing the service or the operator is responsible.
  • Page 11: 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) The three power levels are as follows: ▪...
  • Page 12: Proper Use

    Water pressure 1.0 - 2.5 bar (15 - 36 psi) Spray water flow 35 – 80 cm Spray air pressure 1.0 - 2.5 bar (15 - 36 psi) Can be attached to all MULTIflex (LUX) / MULTIflex LED couplings. PROPHYflex 4 S-Variants can be connected to Sirona quick couplings. 12 / 36...
  • Page 13: Scope Of Delivery

    3.4 Optional accessories PROPHYflex 4 Perio Kit (Mat. no. 1.011.9403) Accessories for subgingival bio-film removal and cleaning of implant surfaces, crowns and bridges Refill PROPHYflex perio tip (Mat. no. 1.010.0287) Set for refilling of PROPHYflex 4 Perio Kits 13 / 36...
  • Page 14: Transportation And Storage Conditions

    Instructions for use PROPHYflex 4 3 Product description | 3.5 Transportation and storage conditions 3.5 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 15: Putting Into Service And Shutting 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 16: Check O-Rings Of The Coupling

    Instructions for use PROPHYflex 4 4 Putting into service and shutting down | 4.2 Check O-rings of the coupling 4 Open the water supply all the way using the spray ring on the coupling. 4.2 Check O-rings of the coupling CAUTION Missing or damaged O-rings.
  • Page 17: Operation

    4 Only use original KaVo powder. 4 Reprocess and refill the powder container before each patient. 4 Comply with the safety data sheets for the KaVo powders. 4 Safety data sheets are available for inspection at www.kavo.com, "Safety data sheets".
  • Page 18: Adjusting The Powder Volume

    Instructions for use PROPHYflex 4 5 Operation | 5.4 Adjusting the powder volume 4 Unscrew the powder container in anticlockwise direction. 4 Before filling the powder container, shake the powder in the refilling bag well. 4 Fill the powder container up to the marking.
  • Page 19: Mounting The Gripping Sleeve

    Instructions for use PROPHYflex 4 5 Operation | 5.5 Mounting the gripping sleeve 5.5 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 4 Mount the ergonomically fitting gripping sleeve on the instrument without tilting it.
  • Page 20: Application Instructions Prophyflex Powder, Prophypearls, Prophyflex Perio Powder

    PROPHYflex Powder and other powders can be aspirated or get into the eyes of the user or patient during treatment. 4 Both patient and user have to wear protective goggles during the treat- ment. 4 KaVo recommends the use of dust extraction and face mask during the treatment with PROPHYflex. 20 / 36...
  • Page 21 Instructions for use PROPHYflex 4 5 Operation | 5.8 Application instructions PROPHYflex Powder, PROPHYpearls, PROPHYflex Perio Powder PROPHYflex Powder PROPHYpearls PROPHYflex Perio Powder Use: Use: Use: ▪ Conservative and aes- ▪ Conservative and ▪ Subgingival treatment thetic dentistry aesthetic dentistry ▪...
  • Page 22: Troubleshooting

    Instructions for use PROPHYflex 4 6 Troubleshooting | 6.1 Cleaning a clogged cannula / Power cannula 6 Troubleshooting Preventive measures ▪ After each treatment and before each sterilisation, unscrew the powder con- tainer in an anticlockwise direction and replace it with a clean powder con- tainer.
  • Page 23: 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 NOTE After using a nozzle needle or cleaning bur, the instrument must be repro- cessed before further use. 4 Pulling off the grip sleeve with cannula.
  • Page 24: Replacing The O-Ring For Powder Container

    Instructions for use PROPHYflex 4 6 Troubleshooting | 6.3 Replacing the O-ring for powder container If the clogging persists: 4 Use the wrench for cannula to unscrew the nozzle by placing the lateral re- cess of the wrench on the nozzle and unscrewing the nozzle.
  • Page 25 Instructions for use PROPHYflex 4 6 Troubleshooting | 6.3 Replacing the O-ring for powder container 4 Carefully push the spare O-ring into the recess using your fingers. 4 Do not damage the spare O-ring when you do this. 25 / 36...
  • Page 26: 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 27: Manual Reprocessing

    Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.3 Manual Reprocessing 4 Unscrew the powder container. 4 Pull the gripping sleeve off. 4 Remove the cannula from the gripping sleeve. 4 Set the powder regulation to the highest level.
  • Page 28: Overview Of The Automated Reprocessing Options

    Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.4 Automated reprocessing 7.4.1 Overview of the automated reprocessing options pre-cleaning Automated in- Automated Automated in- Sterilisation ternal clean- external ternal and ex-...
  • Page 29: Pre-Cleaning

    Instructions for use PROPHYflex 4 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.4 Automated reprocessing NOTE Adapters are needed for automated cleaning. Order adapter separately. Also refer to: 8 Consumables, Page 32 7.4.2 pre-cleaning CAUTION Do not process the medical device in an ultrasonic unit.
  • Page 30: 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. 7.5 Care products and systems – Servicing CAUTION Improper care.
  • Page 31: Sterilisation

    7.7 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with EN 13060 / EN ISO 17665-1 NOTE Cleaning seal PROPHYflex 4 (3.004.6658) remove prior to sterilisation. CAUTION Contact corrosion due to moisture. Damage to product. 4 Immediately remove the product from the steam steriliser after the steril- isation cycle.
  • Page 32 Instructions for use PROPHYflex 4 8 Consumables 8 Consumables Available from specialised dental dealers. Material summary Mat. no. Cannula 3.003.1138 Power cannula 1.012.1000 Powder container 3.002.8136 Rubber cover supragingival 3.004.4708 Rubber cover subgingival 3.004.4709 Cleaning bur 3.004.9870 Nozzle needle 0.573.6052 Nozzle 3.004.2324...
  • Page 33 PROPHYflex 4 Perio Kit Accessories for subgingival bio-film removal and 1.011.9403 cleaning of implant surfaces, crowns and bridges. Refill PROPHYflex perio tip, 10x Set for refilling of PROPHYflex 4 Perio Kits 1.010.0287 (1.011.9403) O-ring for powder container 3.003.0608 O-ring for coupling interface to 1.004.2776...
  • Page 34 Instructions for use PROPHYflex 4 8 Consumables Material summary Mat. no. PROPHYflex Perio Powder, 1.009.3732 4 bottles with 100g 34 / 36...
  • Page 35: Terms And Conditions Of Warranty

    12 months from the date of the invoice, subject to the following conditions: With regard to justified complaints KaVo grants warranty in the form of a free of charge repair or delivery of a replacement. Other claims of any kind whatso- ever, in particular with respect to compensation, are excluded.