KERR Elements 8:1 Instructions For Use Manual
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KERR Elements 8:1 Instructions For Use Manual

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Instructions for use
elements™ 8:1

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Summary of Contents for KERR Elements 8:1

  • Page 1 Instructions for use elements™ 8:1...
  • Page 2 Manufactured for: Distributed by: Kerr Corporation Kerr Australia Pty. Limited 1717 West Collins Avenue Unit 6, 12 Mars Road Orange CA 92867 Lane Cove West, New South Wales 2066 U.S. Australia +1-800-KERR-123 +61-2-8870-3000 www.kerrdental.com Manufacturer: Importer KaVo Dental GmbH Ormco B.V.

  • Page 3: Table Of Contents

    Instructions for use elements™ 8:1 Table of contents Table of contents 1 User instructions ........................ 5 2 Safety..........................8 2.1 Infection hazard ......................8 2.2 Improper use ........................ 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 elements™ 8:1 Table of contents 9 Terms and conditions of warranty ..................30 4 / 32...

  • Page 5: User Instructions

    Congratulations on purchasing this Kerr Endodontics product. By following the instructions below you will be able to work smoothly, economically and safely. KaVo and elements 8:1 are either registered trademarks or trademarks of KaVo Dental GmbH. All other trademarks are property of their respective owners.
  • Page 6 Instructions for use elements™ 8:1 1 User instructions Temperature range Air pressure Relative Humidity Caution: Federal (USA) law restricts device to sale by or on the order only of a dental professional. CE mark (European Conformity mark) Medical device, labelling of medical devices Importer Transport upright with the arrows pointing upwards! Fragile - protect against impact!
  • Page 7 Instructions for use elements™ 8:1 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. 7 / 32...

  • Page 8: Safety

    Instructions for use elements™ 8:1 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

    Instructions for use elements™ 8:1 2 Safety | 2.4 Accessories and combination with other equipment ▶ Check that the device is working properly and is in satisfactory condition before each use. ▶ Have parts with sites of breakage or surface changes checked by the Ser- vice.

  • Page 10: Service And Repair

    Instructions for use elements™ 8:1 2 Safety | 2.6 Service and repair 2.6 Service and repair Repairs, servicing and safety checks may only be performed by trained service personnel. The following persons are authorised to do this: ▪ Service technicians of KaVo branches after the appropriate product training ▪...

  • Page 11: Product Description

    Instructions for use elements™ 8:1 3 Product description | 2.6 Service and repair 3 Product description elements™ 8:1, PN: 815-1655 11 / 32...

  • Page 12: Purpose - Intended Use

    Instructions for use elements™ 8:1 3 Product description | 3.1 Purpose – Intended use 3.1 Purpose – 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 13: Symbols On Product And Rating Plate

    Instructions for use elements™ 8:1 3 Product description | 3.3 Symbols on product and rating plate 3.3 Symbols on product and rating plate The rating plates are affixed to the underside of the unit. Accompanying documents Caution Follow instructions for use Consult instructions for use Please note the electronic instructions for use Certification...

  • Page 14: Transportation And Storage Conditions

    Instructions for use elements™ 8:1 3 Product description | 3.4 Transportation and storage conditions 3.4 Transportation and storage conditions NOTICE Startup after refrigerated storage. Malfunction. ▶ 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). Temperature: -20 °C to +70 °C (-4 °F to +158 °F) Relative humidity: 5% RH to 95% RH absence of condensation Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)

  • Page 15: Startup And Shut Down

    Instructions for use elements™ 8:1 4 Startup and shut down 4 Startup and shut down WARNING Hazard from non-sterile products. Infection hazard for dentist and patient. ▶ Prior to initial startup and after each use, reprocess the product and accessories. WARNING Dispose of the product in appropriate manner.

  • Page 16: Operation

    Instructions for use elements™ 8:1 5 Operation | 5.1 Attaching the medical device 5 Operation 5.1 Attaching the medical device CAUTION Detachment of the medical device during treatment. Injury or property damage A medical device that is not properly locked in place can become disconnected from the motor coupling and fall off.
  • Page 17 Instructions for use elements™ 8:1 5 Operation | 5.3 Inserting the dental bur or diamond grinder WARNING Use of unauthorised dental burs. Risk of injury. ▶ Comply with the instructions for use and the intended use of the dental bur. ▶...

  • Page 18: Removing The Milling Tool Or Diamond Grinder

    Instructions for use elements™ 8:1 5 Operation | 5.4 Removing the milling tool or diamond grinder 5.4 Removing the milling tool or diamond grinder WARNING Hazard from rotating dental bur. Lacerations and damage to the chuck system. ▶ Do not touch the rotating dental bur! ▶...

  • Page 19: Checking For Malfunctions And Troubleshooting

    Instructions for use elements™ 8:1 6 Checking for malfunctions and troubleshooting | 6.1 Check for malfunctions 6 Checking for malfunctions and troubleshooting 6.1 Check for malfunctions CAUTION Product heats up. Burn injury or product damage due to over-heating. ▶ Do not use the product if it is irregularly heated. NOTICE Missing or damaged O-rings.
  • Page 20 Instructions for use elements™ 8:1 6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting ▶ Push the O-ring to the front, and remove it. ▶ Insert new O-rings into the grooves. 20 / 32...

  • Page 21: Reprocessing Steps In Accordance With Iso 17664

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use 7 Reprocessing steps in accordance with ISO 17664 7.1 Preparations at the site of use WARNING Hazard from contaminated products. Contaminated products are associated with an infection hazard.

  • Page 22: Manual External Disinfection

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.2 Manual Reprocessing ▶ Hold the can vertically. ▶ Press the spray button three times for 2 seconds each time. ▶ Remove the medical device from the spray attachment and let the cleanser act for 1 minute.

  • Page 23: Manual Internal Disinfection

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.2 Manual Reprocessing 7.2.4 Manual internal disinfection WARNING Incomplete disinfection. Infection hazard. ▶ Only use disinfection procedures that are verified to be bactericidal, fungi- cidal and virucidal. ▶...

  • Page 24: Automated Reprocessing

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.3 Automated reprocessing 7.3 Automated reprocessing WARNING Incomplete disinfection. Infection hazard. ▶ Only use disinfection procedures that are verified to be bactericidal, fungi- cidal and virucidal. ▶...

  • Page 25: Care Products And Systems - Servicing

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Care products and systems - Servicing ▶ Immediately after drying, lubricate the KaVo medical device with care agents from the KaVo care system. 7.4 Care products and systems - Servicing WARNING Sharp tool in the medical device.

  • Page 26: Care With Kavo Sprayrotor

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.4 Care products and systems - Servicing ▶ Service the product in the QUATTROcare PLUS. See also: 2 Instructions for use KaVo QUATTROcare PLUS Servicing the chuck KaVo recommends servicing the chuck system once a week using the chuck servicing program integrated in the device.

  • Page 27: Servicing With Kavo Quattrocare

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.5 Packaging See also: 2 Instructions for use KaVo SPRAYrotor 7.4.4 Servicing with KaVo QUATTROcare Note QUATTROcare 2104 / 2104 A is no longer included in the current de- livery programme.

  • Page 28: Sterilisation

    Instructions for use elements™ 8:1 7 Reprocessing steps in accordance with ISO 17664 | 7.6 Sterilisation 7.6 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with EN 13060 / EN ISO 17665-1 CAUTION Improper service and care. Risk of injury. ▶...

  • Page 29: Tools And Consumables

    Instructions for use elements™ 8:1 8 Tools and consumables 8 Tools and consumables Available from dental suppliers. Availability may vary depending on region. Material summary Mat. No. INTRA instrument stand 3.005.5204 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 Spray head INTRA (KaVo Spray) 0.411.9911 Service coupling INTRA...
  • Page 30 Instructions for use elements™ 8:1 9 Terms and conditions of warranty 9 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- antees zero defects in respect of material and workmanship for a period of 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-...

This manual is also suitable for:

815-1655

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