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KaVo INTRAmatic contra-angle 14 ES 1.003.4831 Instructions For Use Manual

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Instructions for use
INTRAmatic contra-angle 14 ES - 1.003.4831

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Summary of Contents for KaVo INTRAmatic contra-angle 14 ES 1.003.4831

  • Page 1 Instructions for use INTRAmatic contra-angle 14 ES - 1.003.4831...
  • 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

    Table of contents Table of contents 1 User instructions ............................... 5 2 Safety ................................7 Description of safety instructions ......................7 Safety instructions ..........................9 3 Product description ............................14 Purpose – Intended use ........................15 Technical Specification ......................... 17 Transportation and storage conditions ....................
  • Page 4 Table of contents Remove the medical device ......................... 28 Insert the milling cutters or diamond grinders ..................28 Removing the milling tool or diamond grinder..................32 6 Troubleshooting .............................. 34 Check for malfunctions ......................... 34 Troubleshooting ............................ 35 6.2.1 Troubleshooting: Exchanging the O-rings on the motor coupling ...........
  • Page 5 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A ............................54 7.5.4 Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS 2124 A ............................. 57 7.5.5 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2140 A ... 60...
  • Page 6 Table of contents Packaging ............................. 62 Sterilisation ............................63 Storage ..............................65 8 Tools ................................67 9 Warranty terms and conditions ........................69...

  • Page 7: 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 the chapter on Safety/Warning symbol...
  • Page 8 User instructions Can be steam-sterilised at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) Thermodisinfectable CE mark (European Community). A product bearing this mark meets the requirements of the applicable EC directive. Action request Target group This document is intended for dentists and their assistants.

  • Page 9: Safety

    Safety 2 Safety 2.1 Description of safety instructions Warning symbol Structure DANGER The introduction describes the type and source of the hazard. This section describes potential consequences of non-compliance. ▶ The optional step includes necessary measures for hazard preven‐ tion.
  • Page 10 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. WARNING WARNING indicates a hazardous situation that can lead to serious or fatal injury.

  • Page 11: Safety Instructions

    Safety DANGER DANGER indicates a maximal hazard due to a situation that can directly cause death or fatal injury. 2.2 Safety instructions WARNING Hazards for the care provider and the patient. In the case of damage, irregular running noise, excessive vibration, un- typical warming or when the cutter or grinder cannot be held.
  • Page 12 ▶ A note is to be included in the documents accompanying the dental treatment unit, referring to responsibilities arising from safety, relia‐ bility and performance. ▶ The medical device may only be combined with a treatment centre released by KaVo.
  • Page 13 Safety CAUTION Risk due to incorrectly stored instrument. Injury and infection caused by chucked cutters or grinders. Damage to clamping system from dropping the instrument. ▶ After treatment, place the instrument properly in the cradle, without the cutter or grinder. CAUTION Burning hazard from hot instrument head or hot instruments cover.
  • Page 14 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 non‐ use. Note For safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires.
  • Page 15 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.

  • Page 16: Product Description

    Product description 3 Product description INTRAmatic contra-angle handpiece 14 ES (Mat. no. 1.003.4831)

  • Page 17: Purpose - Intended Use

    Product description 3.1 Purpose – Intended use Purpose: This medical device is ▪ intended for dental treatment only. All other types of use or altera‐ tions to the product are not permitted and can be hazardous. The medical product is intended for the following applications: The re‐ moval of caries, preparation of cavities, removal of fillings, surface processing as well as the polishing and smoothing of dental and re‐...
  • Page 18 Product description Proper use: 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 ▪...

  • Page 19: Technical Specification

    Product description 3.2 Technical Specification Drive speed identification 1 green ring Transmission 4 : 1 With press-button chuck. Short handpiece cutters or grinders can be used. The contra-angle handpiece can be mounted on all INTRAmatic (LUX) motors and motors with a connector in accordance with ISO 3964 / DIN 13940.

  • Page 20: Transportation And Storage Conditions

    Product description 3.3 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 tempera‐ ture of 20°C to 25°C (68°F to 77°F).
  • Page 21 Product description Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture...

  • Page 22: Start Up And Shut Down

    Start up and shut down 4 Start up and shut down WARNING Hazard from nonsterile products. Infection danger to the care provider and patient. ▶ Before first use and after each use, prepare and sterilise the medi‐ cal device if needed. WARNING Disposal of the product in the appropriate manner.

  • Page 23: Check The Amount Of Water

    Start up and shut down 4.1 Check the amount of water CAUTION Overheating of the tooth due to lack of cooling water. Thermal damage to the dental pulp. ▶ Adjust the water amount for the spray cooling to a minimum of 50 /min...
  • Page 24 Start up and shut down...
  • Page 25 Start up and shut down CAUTION Hazard from insufficient spray water. Insufficient spray water can cause the medical device to overheat and damage the tooth. ▶ Check the spray water channels and clean the spray nozzles with the nozzle needle Mat. no. 0.410.0931 if necessary.

  • Page 26: Operation

    Operation 5 Operation 5.1 Attach the medical device WARNING Detachment of the medical device during treatment. A medical device that is not properly locked in place can become dis‐ connected from the motor coupling and fall off. ▶ Carefully pull on the medical device before each treatment to en‐ sure that it is securely locked onto the motor coupling.
  • Page 27 Operation CAUTION Removing and attaching the contra-angle handpiece while the drive mo‐ tor is rotating. Damage to the drive. ▶ Never attach or remove the contra-angle handpiece while the drive motor is rotating!
  • Page 28 Operation CAUTION Damage If the footswitch is pressed while you are connecting and removing the medical device, you can damage the medical device and motor cou‐ pling. ▶ Do not connect or remove the medical device while pressing the footswitch. ▶...
  • Page 29 Operation ▶ Attach the medical device to the motor coupling and turn it until the guide stud audibly snaps into place. ▶ Pull on the medical device to make sure that it is securely affixed to the coupling.

  • Page 30: Remove The Medical Device

    Operation 5.2 Remove the medical device ▶ Unlock the medical device from the motor coupling by twisting it slightly and then pulling it along its axis. 5.3 Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond drill bits that conform to EN ISO 1797-1 type 1, are made of steel or hard metal, and meet the following criteria: - Shaft diameter: 2.334 to 2.35 mm...
  • Page 31 Operation WARNING Use of unauthorised cutters or grinders. Injury to the patient or damage to the medical device. ▶ Observe the instructions for use and use the cutter or grinder prop‐ erly. ▶ Only use cutters or grinders that do not deviate from the specified data.
  • Page 32 Operation CAUTION Injury hazard from cutters or grinders. Infections or cuts. ▶ Wear gloves or fingerstalls. CAUTION Hazard from defective chucking system. The cutter or grinder could fall out and cause injury. ▶ Pull on the cutter or grinder to check that the chucking system is okay and the cutter or grinder is securely held.
  • Page 33 Operation ▶ Insert the cutter or grinder into the segment of the head drive by twisting the tool slightly, and push to the stop. ▶ Check that the tool is seated by pulling on it.

  • Page 34: Removing The Milling Tool Or Diamond Grinder

    Operation 5.4 Removing the milling tool or diamond grinder. WARNING Hazard from rotating cutter or grinder. Lacerations and damage to the chucking system. ▶ Do not touch rotating cutter or grinder.! ▶ Never press the press-button while the cutter or grinder is rotating! ▶...
  • Page 35 Operation ▶ After the cutter or grinder has stopped rotating, press the press-but‐ ton with your thumb and simultaneously pull out the drill bit or bur.

  • Page 36: Troubleshooting

    Troubleshooting 6 Troubleshooting 6.1 Check for malfunctions CAUTION Missing or damaged O-rings. Malfunctions and premature failure. ▶ Make sure that all O-rings are on the coupling and undamaged. CAUTION Heating of the product. Burns or product damage from overheating. ▶ Do not use the product if it is irregularly heated.

  • Page 37: Troubleshooting

    Troubleshooting ▶ The medical device is too hot while idling: Check the amount of cooling air. ▶ The medical device is too hot while working: Caring for the medical device. ▶ When the speed drops or is uneven: Caring for the medical device. ▶...
  • Page 38 Troubleshooting Note The O-rings on the motor coupling may only be lubricated with a cotton ball wetted with KaVo spray. ▶ Press the O-ring between your fingers to form a loop. ▶ Shove the O-ring to the front, and remove it.

  • Page 39: Troubleshooting: Cleaning The Spray Nozzle

    Troubleshooting 6.2.2 Troubleshooting: Cleaning the spray nozzle CAUTION Hazard from insufficient amount of spray water. Insufficient spray water can cause the medical device to overheat and damage the tooth. ▶ Check spray water channels and if necessary clean spray nozzles with the nozzle needle (Mat.

  • Page 40: Preparation Methods According To Iso 17664

    Preparation methods according to ISO 17664 7 Preparation methods according to ISO 17664 7.1 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 41: Cleaning

    Preparation methods according to ISO 17664 7.2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. ▶ Only clean manually or in a thermodisinfector. 7.2.1 Cleaning: Manual cleaning - external Accessories required: ▪ Tap water 30 °C ± 5 °C (86 °F ± 10 °F) ▪...

  • Page 42: Cleaning: Automated External Cleaning

    10 (e.g. Miele G 7781/G 7881 – Validation was carried out with Programme "VARIO-TD", cleaning agent "neodisher mediclean", ® neutralisation agent "neodisher Z" and rinsing agent "neodisher miel‐ ® ® clear" and only applies to the material compatibility with KaVo products).

  • Page 43: Cleaning: Manual Cleaning - Internal

    KaVo CLEANspray and 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...
  • Page 44 Preparation methods according to ISO 17664 ▶ Afterwards, rinse for 3-5 seconds with KaVo DRYspray. See also: KaVo CLEANspray / KaVo DRYspray Instructions for Use Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the following countries: Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxem‐...

  • Page 45: Cleaning: Automated Internal Cleaning

    Preparation methods according to ISO 17664 7.2.4 Cleaning: Automated internal cleaning For alternative interior cleaning, KaVo recommends thermodisinfectors in accordance with EN ISO 15883-1, which are operated with alkaline cleaning agents with a pH value of max. 10 (e. g. Miele G 7781 / G 7881 –...

  • Page 46: Disinfection

    In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry after completion of the cycle, and then grease it immediately with servicing agents from the KaVo care system. 7.3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine.

  • Page 47: Disinfection: Manual Disinfection - External

    Preparation methods according to ISO 17664 7.3.1 Disinfection: Manual disinfection - external KaVo recommends the following products based on compatibility of the materials. The microbiological efficacy must be ensured by the disinfec‐ tant manufacturer and proven by an expert opinion.

  • Page 48: Disinfection: Manual Disinfection - Internal

    The efficacy of manual internal disinfection must be demonstrated by the manufacturer of the disinfection agent. With KaVo products, use only dis‐ infection agents that have been released by KaVo, with respect to the compatibility of materials (e.g. WL-cid / made by ALPRO).

  • Page 49: Disinfection: Machine Disinfection - External And Internal

    Follow the instructions for use of the disinfectant. 7.3.3 Disinfection: Machine disinfection - external and internal For mechanical disinfection, KaVo recommends unwrapped sterilisation in the autoclave at 135° C (preferentially B class). Alternatively, disinfection can be carried out in thermodisinfectors in ac‐...

  • Page 50: Drying

    In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry after completion of the cycle, and then grease it immediately with servicing agents from the KaVo care system. 7.4 Drying Manual Drying ▶...

  • Page 51: Care Products And Systems - Servicing

    Preparation methods according to ISO 17664 Automatic Drying The drying procedure is normally part of the cleaning program of the ther‐ modisinfector. ▶ Follow the instructions for use of the thermodisinfector. 7.5 Care products and systems - Servicing WARNING Sharp cutters or grinders in the medical device. Risk of injury from sharp or pointed cutters or grinders.
  • Page 52 Reduced product life. ▶ Perform regular proper care and maintenance! 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 53: Care Products And Systems - Servicing: Care With Kavo Spray

    Preparation methods according to ISO 17664 7.5.1 Care products and systems - Servicing: Care with KaVo Spray KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion.
  • Page 54 Preparation methods according to ISO 17664 Servicing of the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week. ▶ Remove the cutter or grinder, place the INTRA spray nipple tip in the opening and spray. ▶...

  • Page 55: Care Products And Systems - Servicing: Care With The Kavo Sprayrotor

    Preparation methods according to ISO 17664 7.5.2 Care products and systems - Servicing: Care with the KaVo SPRAYrotor KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐...

  • Page 56: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare 2104 / 2104A

    Preparation methods according to ISO 17664 7.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A Note QUATTROcare 2104 / 2104 A is no longer in the current delivery pro‐ gramme. Follow-up products: ▶ QUATTROcare PLUS 2124 A ▶...
  • Page 57 Preparation methods according to ISO 17664 KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion. ▶ Remove the cutter or grinder. ▶ Servicing the product. See also: Instructions for use KaVo QUATTROcare 2104 / 2104A...
  • Page 58 Preparation methods according to ISO 17664 ▶ Remove the cutter or grinder, place the spray nipple tip in the open‐ ing and spray. ▶ Subsequently treat with the care products and care systems speci‐ fied. See also: Servicing with KaVo QUATTROcare 2104 / 2104A...

  • Page 59: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare Plus 2124 A

    (no validated cleaning of the interior in accordance German RKI require‐ ments) KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion.
  • Page 60 Preparation methods according to ISO 17664 Servicing the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week using the collet servicing program integrated in the device. See also: Instructions for Use KaVo QUATTROcare PLUS 2124 A...
  • Page 61 Preparation methods according to ISO 17664 ▶ Press the handpiece together with the guide bush of the chuck to be serviced against the tip of the service coupling chuck. ▶ Press the button showing the chuck service symbol.

  • Page 62: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare 2140 A

    Option 2: After three minutes with no service procedure running, the de‐ vice automatically switches back to normal service mode. See also: Care with KaVo QUATTROcare PLUS 7.5.5 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2140 A Programme-controlled cleaning and servicing device for perfect care of...
  • Page 63 Preparation methods according to ISO 17664 KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion. ▶ Remove the cutter or grinder. ▶ Service the product in QUATTROcare PLUS.

  • Page 64: Packaging

    Preparation methods according to ISO 17664 7.6 Packaging Note 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! ▶...

  • Page 65: Sterilisation

    Preparation methods according to ISO 17664 7.7 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with 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 Ka‐ Vo care products.
  • Page 66 Preparation methods according to ISO 17664 CAUTION Contact corrosion due to moisture. Damage to product. ▶ Immediately remove the product from the steam steriliser after the sterilisation cycle! The KaVo medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F).

  • Page 67: Storage

    Preparation methods according to ISO 17664 (Depending on the available autoclave,) select a suitable procedure from the following sterilisation processes: ▪ Autoclave with three times initial vacuum: – at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) ▪...
  • Page 68 Preparation methods according to ISO 17664 Note Comply with the expiry date of the sterilised items.

  • Page 69: Tools

    Instrument stand 2151 0.411.9501 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 Nozzle pin 0.410.0931 Silicone hose 150 mm 0.593.0252 Material summary Mat. no. Adaptor INTRAmatic (CLEANspray 1.007.1776 and DRYspray) KaVo CLEANspray 2110 P 1.007.0579 KaVo DRYspray 2117 P 1.007.0580...
  • Page 70 Tools Material summary Mat. no. KaVo Spray 2112 A 0.411.9640 ROTAspray 2 2142 A 0.411.7520 QUATTROcare plus Spray 2140 P 1.005.4525...

  • Page 71: Warranty Terms And Conditions

    12 months from the date of the invoice, subject to the following con‐ ditions: In case of justified complaints, KaVo will honour its warranty with a free replacement or repair. Other claims of any nature whatsoever, in particu‐...
  • Page 72 Warranty terms and conditions or chemical or electrical factors deemed abnormal or impermissible in ac‐ cordance with KaVo's instructions for use or other manufacturer's instruc‐ tions. The warranty granted does not usually extend to lamps, light con‐ ductors made of glass and glass fibres, glassware, rubber parts, and the colourfastness of plastic parts.

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