KaVo RONDOflex plus 360 Instructions For Use Manual
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KaVo RONDOflex plus 360 Instructions For Use Manual

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Instructions for use
RONDOflex plus 360 - 1.002.2179

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Summary of Contents for KaVo RONDOflex plus 360

  • Page 1 Instructions for use RONDOflex plus 360 - 1.002.2179...
  • Page 2 Distribution: 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 RONDOflex plus 360 - 1.002.2179 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 RONDOflex plus 360 - 1.002.2179 Table of contents 8.8 Sterilisation........................26 8.9 Storage ........................26 9 Consumables ........................27 10Terms and conditions of warranty ..................29 4 / 32...

  • Page 5: User Instructions

    RONDOflex® 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 https://www.kavobox.com. KaVo Technical Service...
  • Page 6 Instructions for use RONDOflex plus 360 - 1.002.2179 1 User instructions Manufacturer Manufacturing date Note: Please note accompanying documents Follow the electronic instructions for use HIBC Code CE mark for medical devices Medical device, labelling of medical devices Transportation and storage conditions...
  • Page 7 Instructions for use RONDOflex plus 360 - 1.002.2179 1 User instructions CAUTION In cases which – if not prevented – can lead to material damage. 7 / 32...

  • Page 8: Safety

    Instructions for use RONDOflex plus 360 - 1.002.2179 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 9: Accessories And Combination With Other Equipment

    4 Do not make any modifications to the device unless these have been ap- proved by the manufacturer of the product. 4 Use original KaVo spare parts only. 4 The RONDOflex plus 360 is designed solely for use with KaVo RONDOflex Powder. Also refer to: Instructions for use KaVo RONDOflex Powder 2.5 Qualification of personnel...

  • Page 10: Protective Equipment

    KaVo Repair Service directly: www.kavobox.com NOTE If a repair is done with NON-KaVo original spare parts, this may constitute a product modification that leads to the loss of CE conformity. In the event of damage, the responsibility is with the service company or the operator.

  • Page 11: Description Of The Product

    Instructions for use RONDOflex plus 360 - 1.002.2179 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 only for dental treatment by a dental professional, the product...

  • Page 12: Technical Specifications

    Instructions for use RONDOflex plus 360 - 1.002.2179 3 Description of the product | 3.2 Technical specifications ▪ Powder jets are not an efficient means for removal of major amalgam res- torations since a concerning amount of mercury is released during the abra- sion of amalgam.
  • Page 13 Instructions for use RONDOflex plus 360 - 1.002.2179 3 Description of the product | 3.3 Scope of delivery Description Mat. no. Cannula 110/0.6 mm Mat. no. 1.002.6251 Powder container blue 50µm Mat. no. 1.003.1236 Accessories: Cannula 110°/0.46 mm Mat. no. 1.002.9176 Key for fixing the cannula Mat.

  • Page 14: Transportation And Storage Conditions

    Instructions for use RONDOflex plus 360 - 1.002.2179 4 Transportation and storage conditions 4 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: 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 16: Checking The Pressures

    Instructions for use RONDOflex plus 360 - 1.002.2179 5 Startup and shut down | 5.2 Checking the pressures 5.2 Checking the pressures CAUTION Damage from soiled and moist cooling air/compressed air. Contaminated and moist cooling air can cause malfunctions. 4 Make sure that the supply of cooling air is dry, clean and uncontaminated according to DIN EN ISO 7494-2.

  • Page 17: Operation

    4 Reprocess and refill the powder container before each patient 4 Comply with the safety data sheets for KaVo powders 4 Safety data sheets are available for inspection at www.kavo.com, "Safety data sheets". 4 Unscrew the powder container to the left against the direction of the arrow.

  • Page 18: Inserting The Cannula

    Instructions for use RONDOflex plus 360 - 1.002.2179 6 Operation | 6.4 Inserting the cannula 4 RONDOflex Pulver powder is durable for a virtually unlimited time. 4 Screw on the powder container straight on to the right in the direction of the arrow.

  • Page 19: Use

    Instructions for use RONDOflex plus 360 - 1.002.2179 6 Operation | 6.6 Use 6.6 Use 4 For practicing with the RONDOflex plus, produce a cavity on a disposable mirror to familiarise yourself with the handpiece. NOTE KaVo recommends to use a disposable mirror during treatment.

  • Page 20: Checking For Malfunctions And Troubleshooting

    Instructions for use RONDOflex plus 360 - 1.002.2179 7 Checking for malfunctions and troubleshooting | 7.1 Cleaning a blocked cannula 7 Checking for malfunctions and troubleshooting Possible application errors: Cause Remedy The distance from the tooth surface is Keep a work in distance of 1 mm...
  • Page 21 Instructions for use RONDOflex plus 360 - 1.002.2179 7 Checking for malfunctions and troubleshooting | 7.2 Cleaning a clogged main body 4 Then blow through with compressed air. 4 Re-attach the nozzle carefully and with gentle force with the wrench.

  • Page 22: Reprocessing Steps In Accordance With Iso 17664

    Instructions for use RONDOflex plus 360 - 1.002.2179 8 Reprocessing steps in accordance with ISO 17664 | 8.1 Preparations at the site of use 8 Reprocessing steps in accordance with ISO 17664 8.1 Preparations at the site of use WARNING Hazard from contaminated products.

  • Page 23: Manual External Cleaning

    Malfunction and material damage. 4 Reprocess in a washer disinfector or by hand 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 24: Automated Reprocessing

    Instructions for use RONDOflex plus 360 - 1.002.2179 8 Reprocessing steps in accordance with ISO 17664 | 8.5 Automated reprocessing 8.5 Automated reprocessing WARNING Incomplete disinfection. Infection hazard. 4 Only use disinfection procedures that are verified to be bactericidal, fungi- cidal and virucidal.

  • Page 25: 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. 8.6 Care products and systems - Servicing CAUTION Improper care.

  • Page 26: Sterilisation

    Instructions for use RONDOflex plus 360 - 1.002.2179 8 Reprocessing steps in accordance with ISO 17664 | 8.8 Sterilisation 8.8 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with EN 13060 / EN ISO 17665-1 CAUTION Contact corrosion due to moisture.

  • Page 27: Consumables

    Instructions for use RONDOflex plus 360 - 1.002.2179 9 Consumables 9 Consumables Available from specialised dental dealers. Cleaning cover Mat. no. 3.005.4213 Cleaning adapter Mat. no. 3.006.4667 Protective goggles Mat. no. 1.000.9006 for patient and user RONDOflex Powder 27μm Mat. no. 1.000.5957 1000g RONDOflex Powder 50μm...
  • Page 28 Instructions for use RONDOflex plus 360 - 1.002.2179 9 Consumables O-ring for cannulas Mat. no. 0.200.6019 28 / 32...

  • Page 29: 10Terms 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.

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1.002.2179

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