KaVo INTRAcompact contra-angle 2061 CHC Instructions For Use Manual
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KaVo INTRAcompact contra-angle 2061 CHC Instructions For Use Manual

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Instructions for use
INTRAcompact contra-angle 2061 CHC - REF 1.003.7714

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Summary of Contents for KaVo INTRAcompact contra-angle 2061 CHC

  • Page 1 Instructions for use INTRAcompact contra-angle 2061 CHC - REF 1.003.7714...
  • 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

    Content Content User instructions ..................................6 Terms and conditions of warranty ............................9 Safety ....................................12 Description of safety instructions ............................. 12 Purpose – Proper use ..............................16 Safety instructions ................................ 18 Product description .................................. 24 Technical Specifications ..............................25...
  • Page 4 Content Transportation and storage conditions ..........................27 First use ....................................29 Operation ....................................30 Attaching the medical device ............................30 Removing the medical device ............................33 Inserting the file ................................34 Removing the file ................................. 39 Application .................................. 41...
  • Page 5 Content Reprocessing methods according to ISO 17664 ..........................44 Preparations at the site of use ............................44 Cleaning ..................................45 6.2.1 Cleaning: Manual external cleaning ........................46 6.2.2 Cleaning: Automated external cleaning ....................... 48 6.2.3 Cleaning: Manual internal cleaning ........................49 6.2.4 Cleaning: Automated internal cleaning ........................
  • Page 6 Disinfection: Automated external and internal disinfection ..................56 Drying ..................................57 Care products and systems - Servicing ..........................59 6.5.1 Care products and systems - Servicing: Servicing with KaVo Spray ................61 6.5.2 Care products and systems - Servicing: Servicing with KaVo SPRAYrotor ..............62 6.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare .............
  • Page 7 Content Storage ..................................69 Tools and consumables ................................71...

  • Page 8: 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...
  • Page 9 User instructions Symbols Refer to the Chapter on Safety/Warning symbol Important information for users and service technicians Action request...
  • Page 10 User instructions CE mark (European Community). A product bearing this mark meets the requirements of the applicable EC directive. Can be steam-sterilised at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) Thermodisinfectable...

  • Page 11: 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 guarantees zero defects in respect of material and processing for a period of 12 months from the date of the invoice, subject to...
  • Page 12 User instructions 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. In the event of default, gross negligence or intent, this shall only apply in the absence of mandatory legal regulations to the contrary.
  • Page 13 All liability is excluded if defects or their consequences originate from manipulations or changes to the product made by the customer or a third party that is not authorised by KaVo. 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 or note of delivery.

  • Page 14: Safety

    Safety 2 Safety 2.1 Description of safety instructions Warning symbol...
  • Page 15 Safety Structure DANGER The introduction describes the type and source of the hazard. This section describes the potential consequences of non-observance. ▶ The optional step includes necessary measures for hazard prevention.
  • Page 16 Safety Description of hazard 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 to moderate injuries.
  • Page 17 Safety WARNING WARNING indicates a hazardous situation that can cause death or serious injury. DANGER DANGER indicates a hazardous situation that can directly cause death or serious injury.

  • Page 18: Purpose - Proper Use

    Safety 2.2 Purpose – Proper use This medical device is ▪ intended for dental treatment only. Any other type of use or alteration to the product is imper‐ missible and can be hazardous. The medical device is intended for the following uses: , cavity preparation, caries excavation.
  • Page 19 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, it is the responsibility of the user to: ▪...

  • Page 20: Safety Instructions

    Safety 2.3 Safety instructions WARNING Hazard to the care provider and patient. In case of damage, irregular noise during operation, excessive vibration, atypical heating or when the file cannot be firmly held. ▶ Stop working and contact service support.
  • Page 21 ▶ A note is to be included in the documents accompanying the dental treatment unit, referring to responsibilities arising from safety, reliability and performance. ▶ The medical device may only be combined with a treatment centre released by KaVo.
  • Page 22 Safety CAUTION Risk due to incorrectly stored handpiece. Injury and infection from clamped files. ▶ After treatment, place the handpiece properly in the holder without the file.
  • Page 23 Safety CAUTION Burning hazard from hot handpiece head and handpiece cover. Burn injuries in the mouth may be caused if the handpiece overheats. ▶ Never touch soft tissue with the handpiece head!
  • Page 24 Safety CAUTION Premature wear and malfunctioning from improper storage during long periods of nonuse. Reduced product life. ▶ The medical device should be cleaned, serviced and stored in a dry location, according to instructions, before long periods of nonuse. Note Before each treatment, insert a dental dam for safety reasons.
  • Page 25 KaVo Instructions for Use, and the care products and care systems described therein must be used. KaVo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device. This service interval should take into account the frequency of use.

  • Page 26: Product Description

    Product description 3 Product description INTRAcompact contra-angle handpiece 2061 CHC ( Mat. no. 1.003.7714...

  • Page 27: Technical Specifications

    Product description 3.1 Technical Specifications Drive speed max. 20,000 min Axial stroke movement 0.8 mm Identification 1 yellow ring Transmission ratio 1 : 1 36 latched positions. Shock absorption due to spring.
  • Page 28 Product description 0,8 mm A rotational movement inside the handpiece is converted to a damped axial stroke movement.

  • Page 29: Transportation And Storage Conditions

    Product description The contra-angle handpiece can be mounted on all INTRAmatic (LUX) motors, and motors with a connection in accordance with ISO 3964 / DIN 13940. 3.2 Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored refrigerated. This can cause the medical device to malfunction.
  • Page 30 Product description 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) Protect from moisture...

  • Page 31: First Use

    First use 4 First use WARNING Hazard from non-sterile products. Infection hazard for care provider and patient. ▶ Before first use and after each use, sterilise the medical device.

  • Page 32: Operation

    Operation 5 Operation 5.1 Attaching the medical device WARNING Detachment of the medical device during treatment. A medical device that is not properly locked in place can become disconnected 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 33 Operation CAUTION Removing and attaching the contra-angle handpiece while the drive motor is rotating. Damage to the drive. ▶ Never attach or remove the contra-angle handpiece while the drive motor is rotating!
  • Page 34 Operation ▶ Place the medical device on the (LUX) motor coupling and lock it into place.

  • Page 35: Removing The Medical Device

    Operation ▶ Before each treatment, pull on the medical device to check that it is securely seated in the motor coupling. 5.2 Removing the medical device ▶ Unlock the medical device from the (LUX) motor coupling by twisting it slightly and then pulling it along its axis.

  • Page 36: Inserting The File

    Operation 5.3 Inserting the file Note Manufacturer of files: Intensiv...
  • Page 37 Operation WARNING Use of non-approved files. Injury to the patient or damage to the medical device. ▶ Only use files that do not deviate from the specified data.
  • Page 38 Operation CAUTION Danger of injury from files Infections or cuts. ▶ Wear gloves or finger stalls.
  • Page 39 Operation ▶ Push the file into the segment in the retaining bore in the head and press it against the stop. ▶ Check that the tool is seated securely by pulling on it.
  • Page 40 Operation ▶ Turn the knurled wheel to fix the file. 36 individual locking positions can be selected.

  • Page 41: Removing The File

    Operation 5.4 Removing the file WARNING Danger from axial movement of file. Lacerations. ▶ Do not touch file when moving in axial direction! ▶ Never eject file while in mouth. ▶ Remove the file from the medical device after treatment to avoid injury and infection during storage.
  • Page 42 Operation ▶ When the file has stopped moving, push file out of the head with ejector and remove it.

  • Page 43: Application

    Operation 5.5 Application The INTRAcompact contra-angle 2061 CHC with fixing head can be used with files from Intensiv in the following areas: ▪ finishing box preparations with the Cavishape file, ® ▪ bevelling edges in composite fillings and in/onlay and in margin finishing for crown prepara‐...
  • Page 44 Operation CAUTION Overheating of the tooth due to insufficient amount of cooling water. Thermal damage to the dental pulp. ▶ Ensure that the water spray is ample! Note Before each treatment, insert a dental dam for safety reasons.
  • Page 45 Operation ▶ Use files with light pressure. ▶ For the specific method of operation, please refer to the description contained in the respective file kit.

  • Page 46: Reprocessing Methods According To Iso 17664

    Reprocessing methods according to ISO 17664 6 Reprocessing methods according to ISO 17664 6.1 Preparations at the site of use WARNING Hazard from nonsterile products. There is a risk of infection from contaminated medical devices. ▶ Take suitable personal protective measures. ▶...

  • Page 47: Cleaning

    Reprocessing methods according to ISO 17664 ▶ The medical device must be dry when transported for reconditioning. ▶ Do not place it in a solution or similar. ▶ Recondition the medical device as soon as possible after treatment. 6.2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit.

  • Page 48: Cleaning: Manual External Cleaning

    Reprocessing methods according to ISO 17664 6.2.1 Cleaning: Manual external cleaning Accessories required: ▪ Tap water 30 °C ± 5 °C (86 °F ± 10 °F) ▪ Brush, e.g. medium-hard toothbrush...
  • Page 49 Reprocessing methods according to ISO 17664 ▶ Brush off under flowing tap water.

  • Page 50: Cleaning: Automated External Cleaning

    Reprocessing methods according to ISO 17664 6.2.2 Cleaning: Automated external cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883-1, e.g. Miele G 7781 / G 7881. (Validation was performed with the program "VARIO-TD", the detergent "neodisher mediclean", the ® neutraliser "neodisher Z"...

  • Page 51: Cleaning: Manual Internal Cleaning

    Can only be done with KaVo CLEANspray or KaVo DRYspray. ▶ 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 52 Reprocessing methods according to ISO 17664 Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the fol‐ lowing countries: Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxembourg, Belgium, Netherlands, United Kingdom, Denmark, Sweden, Finland and Norway.

  • Page 53: Cleaning: Automated Internal Cleaning

    Reprocessing methods according to ISO 17664 6.2.4 Cleaning: Automated internal cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883-1, e.g. Miele G 7781 / G 7881. (Validation was performed with the program "VARIO-TD", the detergent "neodisher mediclean", the ® neutraliser "neodisher Z"...

  • Page 54: Disinfection

    Reprocessing methods according to ISO 17664 ▶ Directly after automated cleaning, treat the medical device with the care products and systems provided by KaVo. 6.3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. Defects in the product.

  • Page 55: Disinfection: Manual External Disinfection

    Reprocessing methods according to ISO 17664 6.3.1 Disinfection: Manual external disinfection KaVo recommends the following products based on material compatibility. The microbiological ef‐ ficacy must be ensured by the disinfectant manufacturer.
  • Page 56 Reprocessing methods according to ISO 17664 ▪ Microcide AF made by Schülke&Mayr (liquid or cloths) ▪ FD 322 made by Dürr ▪ CaviCide made by Metrex Consumables required: ▪ Cloths for wiping off the medical device. ▶ Spray the disinfectant on a cloth, then wipe down the medical device and allow the disinfectant to act according to the instructions of the disinfectant manufacturer.

  • Page 57: Disinfection: Manual Internal Disinfection

    Reprocessing methods according to ISO 17664 Note Follow the instructions for use of the disinfectant. 6.3.2 Disinfection: Manual internal disinfection For the effective re-preparation, the inside of the device must be cleaned automatically in a cleaning and disinfection unit in accordance with ISO 15883-1. The interior of this product is not designed for manual disinfection.

  • Page 58: Disinfection: Automated External And Internal Disinfection

    Reprocessing methods according to ISO 17664 6.3.3 Disinfection: Automated external and internal disinfection KaVo recommends thermodisinfectors in accordance with ISO 15883-1, e.g. Miele G 7781 / G 7881. (Validation was performed with the program "VARIO-TD", the detergent "neodisher mediclean", the ®...

  • Page 59: Drying

    Reprocessing methods according to ISO 17664 ▶ Directly after automated cleaning, treat the medical device with the care products and systems provided by KaVo. 6.4 Drying Manual Drying ▶ Blow off the outside and inside with compressed air until water drops are no longer visible.
  • Page 60 Reprocessing methods according to ISO 17664 Note Please observe the instructions for use of the thermodisinfector.

  • Page 61: Care Products And Systems - Servicing

    Reprocessing methods according to ISO 17664 6.5 Care products and systems - Servicing CAUTION Sharp files in the medical device. Danger of injury from sharp and/or pointed files. ▶ Remove the file...
  • Page 62 Premature wear and malfunctions from improper servicing and care. Reduced product life. ▶ Perform proper care regularly! 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 63: Care Products And Systems - Servicing: Servicing With Kavo Spray

    Reprocessing methods according to ISO 17664 6.5.1 Care products and systems - Servicing: Servicing with KaVo Spray KaVo recommends servicing the product after each time it is used, i.e. after each automatic cleaning and before each sterilisation. ▶ Remove file.

  • Page 64: Care Products And Systems - Servicing: Servicing With Kavo Sprayrotor

    Reprocessing methods according to ISO 17664 6.5.2 Care products and systems - Servicing: Servicing with KaVo SPRAYrotor KaVo recommends servicing the product after each time it is used, i.e. after each automatic cleaning and before each sterilisation. ▶ Remove file.

  • Page 65: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare

    Reprocessing methods according to ISO 17664 ▶ Place the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a Cleanpac bag. ▶ Servicing the product. See also: Instructions for use KaVo SPRAYrotor 6.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare...
  • Page 66 Reprocessing methods according to ISO 17664 KaVo recommends servicing the product after each time it is used, i.e. after each automatic cleaning and before each sterilisation. ▶ Remove file.

  • Page 67: Packaging

    The sterilisation bag must be large enough for the handpiece so that the bag is not stretched. The quality and use of the sterilisation packaging must satisfy applicable standards and be suitable for the sterilisation procedure! ▶ Individually weld the medical device in the sterilised item packaging (such as KaVo STERI‐ clave bags Mat. no. 0.411.9912)!

  • Page 68: Sterilisation

    Reprocessing methods according to ISO 17664 6.7 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 69 Reprocessing methods according to ISO 17664 CAUTION Contact corrosion due to moisture. Damage to product. ▶ Immediately remove the product from the steamsteriliserafter the sterilisation cycle!
  • Page 70 The medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F). KaVo recommends, e.g. - STERIclave B 2200/ 2200P from KaVo Citomat / K series from Getinge Depending on the device, select a suitable process from the following sterilisation processes.
  • Page 71 Reprocessing methods according to ISO 17664 Autoclave with a triple pre-vacuum for at least 4 minutes at 134 °C ± 1 °C (273 °F ± 1.8 °F) Autoclave with gravitation process for at least 10 minutes at 134 °C ± 1 °C (273 °F ± 1.8 °F) Autoclave with gravitation process for at least 60 minutes at 121°C ±...
  • Page 72 Reprocessing methods according to ISO 17664 Note Comply with the expiry date of the sterilised items.
  • Page 73 Tools and consumables 7 Tools and consumables Obtainable from the dentalmed. specialist supplier Material summary Mat. no. Handpiece stand 2151 0.411.9501 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 File kit 0.220.2826 Pusher 0.410.0634...
  • Page 74 Tools and consumables Material summary Mat. no. KaVo CLEANspray 1.007.0579 KaVo DRYspray 1.007.0580 KaVo Spray 2112 A 0.411.9640 ROTAspray 2142 A 0.411.7520 QUATTROcare plus Spray 2108 P 1.005.4525...

This manual is also suitable for:

1.003.7714

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