KaVo INTRA shank C 09 Instructions For Use Manual
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KaVo INTRA shank C 09 Instructions For Use Manual

KaVo INTRA shank C 09 Instructions For Use Manual

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Instructions for use
INTRA shank C 09 - REF 1.001.2278

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Summary of Contents for KaVo INTRA shank C 09

  • Page 1 Instructions for use INTRA shank C 09 - REF 1.001.2278...
  • Page 2 Distributed by: Manufacturer: KaVo Dental GmbH Kaltenbach & Voigt GmbH Bismarckring 39 Bismarckring 39 D-88400 Biberach D-88400 Biberach Tel. +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...

  • Page 3: Table Of Contents

    Table of contents Table of contents 1 User instructions ............................... 4 1.1 Warranty terms and conditions ......................... 6 2 Safety ................................8 2.1 Description of safety instructions ......................8 2.2 Purpose – Proper use ..........................10 2.3 Safety instructions ..........................12 3 Product description ............................
  • Page 4 Table of contents 5 Operation ................................ 21 5.1 Attach the medical device ........................21 5.2 Remove the medical device ........................24 5.3 Insert INTRA head ..........................24 5.4 Removing the INTRA head ........................25 6 Preparation methods according to ISO 17664 ....................26 6.1 Preparations at the site of use ........................
  • Page 5 6.7.1 Care products and systems - Servicing: Care with KaVo spray ..........39 6.7.2 Care products and systems - Servicing: Care with the KaVo SPRAYrotor ........ 40 6.7.3 Care products and systems - Servicing: Care with KaVo QUATTROcare ......... 41 6.8 Packaging ...............................

  • Page 6: User Instructions

    User instructions 1 User instructions Dear User Congratulations on purchasing this KaVo quality product. By following the instructions below you will be able to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH Symbols Refer to Safety/Warning chapter...
  • Page 7 User instructions Action request CE mark (Communauté Européenne). A product bearing this mark meets the requirements of the applicable EC directive. Sterilisable in steam up to 135°C (275°F) Thermodisinfectable Target group This document is intended for dentists and their assistants. The section on starting up is also intended for service technicians.

  • Page 8: Warranty Terms And Conditions

    12 months from date of invoice, subject to the following conditions: In case of justified complaints, KaVo will honour its warranty with a free replacement or repair. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded.
  • Page 9 User instructions cordance with KaVo's instructions for use or other manufacturer's instruc‐ tions. No liability is assumed when defects or their consequences are derived from manipulations or changes to the product by the customer or a third party. Service warranty claims will only be accepted if the product is submitted along with proof of purchase in the form of a copy of the invoice/delivery note.

  • Page 10: Safety

    Safety 2 Safety 2.1 Description of safety instructions Warning symbol Structure DANGER The introduction describes the type and source of the danger. This section illustrates the potential consequences of non-observance. ▶ The optional step covers necessary measures for avoiding hazards.
  • Page 11 Safety Description of danger levels The safety instructions listed here, together with the three levels of danger will help avert property damage and injury. CAUTION CAUTION indicates a hazardous situation that can cause damage to property, or mild or moderate physical harm. WARNING WARNING indicates a hazardous situation that can cause death or serious injury.

  • Page 12: Purpose - Proper Use

    Safety DANGER DANGER indicates the maximum hazard level. indicates a hazardous situation that can directly cause death or serious injury. 2.2 Purpose – Proper use This medical device is ▪ intended for dental treatment only. All other types of use or alterations to the product are not permitted and can be hazardous.
  • Page 13 Safety According to these regulations, this medical device may only be used for the described application by a knowledgeable user. The following must be observed: ▪ the applicable health and safety regulations ▪ the applicable accident prevention regulations ▪ these Instructions for use According to these regulations, the user is required to: ▪...

  • Page 14: Safety Instructions

    Safety 2.3 Safety instructions WARNING Hazard to the care provider and patient Damage, irregular noise during operation, excessive vibration, unusual build-up of heat. ▶ Stop work and seek service support.
  • Page 15 ▪ Technicians specially trained by KaVo To ensure proper function, the medical device must be set up according to the methods described in the KaVo instructions for use, and the care prod‐ ucts and methods described therein must be used. KaVo recommends...
  • Page 16 This service in‐ terval should take into account the frequency of use. Service may only be provided by repair shops that have undergone training by KaVo and that use original KaVo replacement parts.

  • Page 17: Product Description

    Product description 3 Product description INTRA shank C 09 (Mat. no. 1.001.2278)

  • Page 18: Technical Specification

    9 : 1 Maximum speed max. 4,400 rpm The INTRA shank C 09 can be disassembled. See also: 6.2 Disassemble medical device, Page 27 INTRA Heads can be inserted. The reducing shank can be mounted on all INTRAmatic motors, and motors...

  • Page 19: Transportation And Storage Conditions

    Product description 3.2 Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored strongly refrigerated. This can cause the medical device to malfunction. ▶ Prior to start-up, very cold products must be heated to a temperature of 20°C to 25°C (68°F to 77°F).
  • Page 20 Product description Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture.

  • Page 21: First Use

    First use 4 First use WARNING Hazard from non-sterile products. Infection danger to the care provider and patient. ▶ Before first use and after each use, sterilise the medical device. 4.1 Cooling medium supply CAUTION Hazard of air embolism and skin emphysema. There is a danger that the insufflation of spray in open wounds in the surgical area can cause air embolisms and skin emphysema.
  • Page 22 First use ▶ Switch off spray-air and spray-water supply on the treatment device. ▶ Cooling the drill bit or bur via external supply. ▶ During surgical interventions, comply with the necessary precautions regarding cooling. ▶ Use physiological, sterile cooling fluid. ▶...

  • Page 23: Attach The Medical Device

    Operation 5 Operation 5.1 Attach the medical device WARNING Loosening of the medical device during treatment. A medical device that is not properly locked in place can become discon‐ nected from the motor coupling and fall off. ▶ Carefully pull on the medical device before each treatment to ensure that it is securely locked onto the motor coupling.
  • Page 24 Operation CAUTION Removing and attaching the handpiece while the drive motor is rotating. Damage to the catch. ▶ Never attach or remove the reducing shank while the device is ro‐ tating!
  • Page 25 Operation ▶ Connect the medical device to the (LUX) motor coupling until it locks into place, and twist it until the catch audibly locks in place. ▶ Pull on it to make sure that the medical device is securely affixed to the coupling.

  • Page 26: Remove The Medical Device

    Operation 5.2 Remove the medical device ▶ Unlock the medical device from the (LUX) motor coupling by twisting it slightly and then pulling it along its axis. 5.3 Insert INTRA head CAUTION Loosening of the medical device during treatment. If the head is not properly locked in place, it can fall out during treatment. ▶...

  • Page 27: Removing The Intra Head

    Operation ▶ Rotate the clamping ring in the direction of the arrow against the stop and hold it there. ▶ Insert the head to the stop. Make sure that the catches engage prop‐ erly. ▶ Rotate the clamping ring against the direction of the arrow to close it and then tighten it.

  • Page 28: Preparation Methods According To Iso 17664

    Preparation methods according to ISO 17664 6 Preparation methods according to ISO 17664 6.1 Preparations at the site of use WARNING Hazard from non-sterile products. There is a risk of infection from contaminated medical devices. ▶ Observe suitable personal protective measures. Note Immediately disassemble and thoroughly clean the medical device after each surgical intervention since malfunctions could otherwise occur.

  • Page 29: Disassemble Medical Device

    Preparation methods according to ISO 17664 ▶ Do not place it in a solution or the like. ▶ Prepare the medical device directly after treatment. Note For rehabilitation, remove the head from the shank. 6.2 Disassemble medical device ▶ Remove the INTRA head from the medical device. ▶...

  • Page 30: Assembling The Medical Device

    Preparation methods according to ISO 17664 6.3 Assembling the medical device ▶ Place the gripping sleeve ① on the conical sleeve ② and screw tight. 6.4 Cleaning CAUTION Malfunctions from cleaning in an ultrasonic unit. Defects in the product. ▶ Only clean manually or in a thermodisinfector. 6.4.1 Cleaning: Manual cleaning - external Accessories required: ▪...

  • Page 31: Cleaning: Automated External Cleaning

    Preparation methods according to ISO 17664 ▶ Brush off under flowing tap water. Note Never use alkaline or chlorine-containing disinfectants. 6.4.2 Cleaning: Automated external cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883-1,...

  • Page 32: Cleaning: Manual Cleaning - Internal

    "neodisher mediclean", the neutraliser "neodisher Z" and rinse "neodish‐ ® ® mielclear" and only refers to the material compatibility with KaVo prod‐ ® ucts.) ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector.
  • Page 33 Preparation methods according to ISO 17664 ▶ Cover the medical device with the KaVo CLEANpac bag, and place it on the corresponding care adapter. Press the spray button three times for 2 seconds each time. Remove the medical device from the spray attachment and let the cleaner work for one minute.

  • Page 34: Cleaning: Automated Internal Cleaning

    "neodisher mediclean", the neutraliser "neodisher Z" and rinse "neodish‐ ® ® mielclear" and only refers to the material compatibility with KaVo prod‐ ® ucts.) ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector.

  • Page 35: Disinfection

    Preparation methods according to ISO 17664 6.5 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. Defects in the product. ▶ Only disinfect in a thermodisinfector or manually.

  • Page 36: Disinfection: Manual Disinfection - External

    Preparation methods according to ISO 17664 6.5.1 Disinfection: Manual disinfection - external KaVo recommends the following products based on material compatibility. The microbiological efficacy must be ensured by the disinfectant manufac‐ turer. ▪ Microcide AF from Schülke&Mayr (liquid or cloths) ▪...

  • Page 37: Disinfection: Manual Disinfection - Internal

    Preparation methods according to ISO 17664 Tools required: ▪ Cloths for wiping down the medical device. ▶ Spray the disinfectant on a cloth, then thoroughly wipe down the med‐ ical device and leave the disinfectant to soak in according to the in‐ structions from the disinfectant manufacturer.

  • Page 38: Disinfection: Machine Disinfection - External And Internal

    "neodisher mediclean", the neutraliser "neodisher Z" and rinse "neodish‐ ® ® mielclear" and only refers to the material compatibility with KaVo prod‐ ® ucts.) ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector.

  • Page 39: Drying

    Preparation methods according to ISO 17664 6.6 Drying Manual drying ▶ Blow off the outside and inside with compressed air until water drops are no longer visible. Machine drying The drying procedure is normally part of the cleaning program of the ther‐ modisinfector.

  • Page 40: Care Products And Systems - Servicing

    Note For care, remove the head from the reducing shank. Note KaVo only guarantees that its products will function properly when the care products used are those listed as accessories, as they were tested for proper use on our products.

  • Page 41: Care Products And Systems - Servicing: Care With Kavo Spray

    Preparation methods according to ISO 17664 6.7.1 Care products and systems - Servicing: Care with KaVo spray KaVo recommends servicing the project after each time it used, i.e. after each automatic cleaning and before each sterilisation. ▶ Cover the product with the Cleanpac bag.

  • Page 42: Care Products And Systems - Servicing: Care With The Kavo Sprayrotor

    Preparation methods according to ISO 17664 6.7.2 Care products and systems - Servicing: Care with the KaVo SPRAYr‐ otor KaVo recommends servicing the project after each time it used, i.e. after each automatic cleaning and before each sterilisation. ▶ Place the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a CLEANpac bag.

  • Page 43: Care Products And Systems - Servicing: Care With Kavo Quattrocare

    6.7.3 Care products and systems - Servicing: Care with KaVo QUAT‐ TROcare Cleaning and care unit with expansion pressure for effective cleaning and care. KaVo recommends servicing the project after each time it used, i.e. after each automatic cleaning and before each sterilisation. ▶ Servicing the product.

  • Page 44: Packaging

    The quality and use of the sterilised product packaging must satisfy ap‐ plicable standards and be suitable for the sterilisation procedure. ▶ Individually weld the medical device in the sterilised item packaging (such as KaVo STERIclave bags Mat. no. 0.411.9912)!

  • Page 45: Sterilisation

    Preparation methods according to ISO 17664 6.9 Sterilisation Sterilisation in a steam steriliser (Autoclave) EN 13060/ISO 17665-1 CAUTION Premature wear and malfunctions from improper servicing and care. Reduced product life. ▶ Before each sterilisation cycle, service the medical device with KaVo care products.
  • Page 46 ▶ Immediately remove the product from the steam steriliser after the sterilisation cycle! The medical device is resistant to temperatures up to 138℃ (280.4°F). KaVo recommends e.g. - STERIclave B 2200/ 2200P from KaVo Citomat / K series from Getinge...

  • Page 47: Storage

    Preparation methods according to ISO 17664 Depending on the device, select a suitable process from the following ster‐ ilisation processes. Autoclave with a triple pre-vacuum for least four minutes at 134°C ± 1°C (273°F ± 1.8°F) Autoclave with gravitation process for least ten minutes at 134°C ± 1°C (273°F ±...
  • Page 48 Preparation methods according to ISO 17664 Note Observe the expiration date of the sterilised item.

  • Page 49: Tools

    Obtainable from dental and medical suppliers Material summary Mat. no. Instrument stand 2151 0.411.9501 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 Spray hose, sterilisable 0.065.5188 (yard ware) Material summary Mat. no. KaVo CLEANspray 1.007.0579 KaVo DRYspray 1.007.0580 KaVo Spray 2112 A 0.411.9640...
  • Page 50 Tools Material summary Mat. no. ROTAspray 2142 A 0.411.7520 QUATTROcare plus Spray 2108 P 1.005.4525...

This manual is also suitable for:

1.001.2278

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