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Instructions for use
INTRAmatic handpiece 10 ES - REF 1.003.1111

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Summary of Contents for KaVo INTRAmatic 10 ES

  • Page 1 Instructions for use INTRAmatic handpiece 10 ES - REF 1.003.1111...
  • 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 Table of contents User instructions Warranty terms and conditions Safety Description of safety instructions Purpose – Intended use Safety instructions Product description Technical Specification Transportation and storage conditions First use Check the amount of water...
  • Page 4: Table Of Contents

    Table of contents Operation Attach the medical device Remove the medical device Insert the handpiece or contra-angle handpiece drill bit. Remove the handpiece or contra-angle drill bit Conversion for contra-angle handpiece drill bit Preparation methods according to ISO 17664 Preparations at the site of use Cleaning 6.2.1 Cleaning: Manual cleaning - external...
  • Page 5: Table Of Contents

    Care products and systems - Servicing 6.5.1 Care products and systems - Servicing: Care with KaVo Spray 6.5.2 Care products and systems - Servicing: Care with the KaVo SPRAYrotor 6.5.3 Care products and systems - Servicing: Care with KaVo QUATTROcare Packaging...
  • Page 6: User Instructions

    User instructions 1 User instructions Dear user, Congratulations for purchasing this KaVo quality product. Following the in‐ structions below will allow you to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH Symbols Refer to chapter Safety/Warning Important information for users and technicians...
  • Page 7 User instructions Thermodisinfectable Sterilisable in steam up to 135°C (275°F) CE mark (Communauté Européenne). A product with this mark meets the requirements of the applicable EC directive. Action request 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 data 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. The warranty does not usually cover lamps, light conductors made of glass and glass fibres, glassware, rubber parts and the colourfastness of plastic parts. Defects or their consequences that can be attributed to interventions on or changes made to the product by the customer or a third party not authorised by KaVo are excluded from the warranty.
  • 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 portrays the possible consequences of non-observance. ▶ The optional step covers necessary measures for avoiding hazards.
  • Page 11 Safety Description of danger levels The safety instructions cited herein 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 - Intended Use

    Safety DANGER DANGER indicates the maximum hazard level. indicates a directly hazardous sit‐ uation that can cause death or serious injury. 2.2 Purpose – Intended use This medical device is ▪ Only intended for dental treatment. Any other type of use or alteration to the product is impermissible and can be hazardous.
  • Page 13 Safety According to these provisions, this medical device may only be used for the described application by a knowledgeable user. The following must be ob‐ served: ▪ 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 CAUTION Premature wear and malfunctioning from improper storage during long periods of nonuse. Reduced production time. ▶ The instrument must be cleaned, serviced and stored dry if it has not been used for a long period.
  • Page 15 Safety WARNING Hazard to the care provider and patient Damage, irregular noise during operation, excessive vibration, unusual build-up of heat or if the cutter or grinder cannot be firmly held. ▶ Stop work and seek service support. CAUTION Hazard from improperly putting away instruments. Injury and infection caused by chucked cutters or grinders.
  • Page 16 ▪ 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 specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.
  • Page 17: Product Description

    Product description 3 Product description INTRAmatic handpiece 10 ES (Mat. no. 1.003.1111) 3.1 Technical Specification Drive speed identification 1 blue ring...
  • Page 18 Product description Transmission 1 : 1 Maximum speed Handpiece cutters or grinders can be used. Short handpiece cutters or grinders can be used after conversion. The handpiece can be mounted on all INTRAmatic Lux motors, and motors with a connection in accordance with ISO 3964 / DIN 13940.
  • 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 re‐ frigerated. 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 1,060 hPa (10 psi to 15 psi) Protect from moisture...
  • Page 21: First Use

    First use 4 First use WARNING Hazard from nonsterile products. Infection danger to the care provider and patient. ▶ Before first use and after each use, sterilise the medical device. 4.1 Check the amount of water CAUTION Overheating of the tooth due to lack of cooling water. Thermal damage to the pulp.
  • Page 22 First use 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. 0.410.0921 if necessary.
  • Page 23: Operation

    Operation 5 Operation 5.1 Attach the medical device CAUTION Connect to the drive motor. Handpiece blocked. ▶ Only start the handpiece when the chuck is closed. CAUTION Removing and attaching the handpiece while the drive motor is rotating. Damage to the catch. ▶...
  • Page 24 Operation WARNING Damage to the medical device. A medical device that is not properly locked in place can release from the motor coupling and fall off. ▶ Carefully pull on it before each treatment to ensure that the medical device is securely locked on the motor coupling.
  • Page 25 Operation ▶ Place the medical device on the motor coupling and lock it into 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 and remove it by twisting it slightly on its axis.
  • Page 27: Insert The Handpiece Or Contra-Angle Handpiece Drill Bit

    Operation 5.3 Insert the handpiece or contra-angle handpiece drill bit. Note Only use handpiece or contra-angle handpiece drill bits that correspond to DIN EN ISO 1797-1 type 1 and type 2, are made of steel or hard metal and meet the following criteria: - Shaft diameter: 2.334 to 2.35 mm with bit stop: - Shaft clamping length: 12 mm...
  • Page 28 Operation WARNING Use of impermissible 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 indicated data.
  • Page 29 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 can fall out and cause injury. ▶ Pull on the cutter or grinder to check if the chucking system is okay and the cutter or grinder is securely held.
  • Page 30 Operation ▶ Hold the grip sleeve, rotate the sleev all the way in the direction of the arrow, and insert the handpiece cutter or grinder into the chuck. ▶ Hold the grip sleeve, and turn the sleeve into the initial position. ▶...
  • Page 31: Remove The Handpiece Or Contra-Angle Drill Bit

    Operation 5.4 Remove the handpiece or contra-angle drill bit WARNING Hazard from rotating cutter or grinder. Lacerations and damage to the chucking system. ▶ Do not touch the cutter or grinder when it is rotating! ▶ Do not touch soft tissue with the head/tip that can heat and burn the soft tissue.
  • Page 32: Conversion For Contra-Angle Handpiece Drill Bit

    Operation 5.5 Conversion for contra-angle handpiece drill bit Note The handpiece must be converted to use contra-angle handpiece drill bits. ▶ Open the handpiece chuck. ▶ Insert the accompanying drill bit stop into the chuck. ▶ Press the contra-angle handpiece drill bit against the stop, close the clamping ring and make sure that the bit is firmly seated.
  • Page 33: 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 nonsterile products. An infection hazard exists from contaminated medical devices. ▶ Observe suitable personal protective measures. ▶ Remove residual cement, composite or blood at the site of use.
  • Page 34: Cleaning

    Preparation methods according to ISO 17664 6.2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. ▶ Only clean in a thermodisinfector or manually. 6.2.1 Cleaning: Manual cleaning - external Required accessories: ▪ Tap water 30°C ± 5°C (86°F ± 10°F) or a 60 to 70% alcohol solution ▪...
  • Page 35: Cleaning: Automated External Cleaning

    Preparation methods according to ISO 17664 ▶ Brush off under flowing tap water, or clean with a 60-70% alcohol solution. 6.2.2 Cleaning: Automated external cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883-1, e.g. Miele G 7781/G 7881...
  • Page 36: Cleaning: Manual Cleaning - Internal

    Z" and rinse "neodisher ® ® ® mielclear" and only refers to the material compatibility with KaVo products.) ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector.
  • Page 37 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 38: Cleaning: Automated Internal Cleaning

    Z" and rinse "neodisher ® ® ® mielclear" and only refers to the material compatibility with KaVo products.) ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector.
  • Page 39: Disinfection

    Preparation methods according to ISO 17664 6.3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or chlorine-containing dis‐ infectant. Defects in the product. ▶ Only disinfect in a thermodisinfector or manually.
  • Page 40: Disinfection: Manual Disinfection - External

    Preparation methods according to ISO 17664 6.3.1 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 by Schülke&Mayr (liquid or cloths) ▪...
  • Page 41: Disinfection: Manual Disinfection - Internal

    Preparation methods according to ISO 17664 Required tools: ▪ Cloths for wiping off 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 42: Disinfection: Machine Disinfection - External And Internal

    Z" and rinse "neodisher ® ® ® mielclear" and only refers to the material compatibility with KaVo products.) ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector.
  • Page 43: Drying

    Preparation methods according to ISO 17664 6.4 Drying Manual drying ▶ Blow off the outside and inside the compressed air until no water drops are visible. Machine drying The drying procedure is normally part of the cleaning program of the ther‐ modisinfector.
  • Page 44: Care Products And Systems - Servicing

    Preparation methods according to ISO 17664 6.5 Care products and systems - Servicing CAUTION Sharp cutters or grinders in the medical device. Injury hazard from sharp and/or pointed cutters or grinders. ▶ Remove the cutter or grinder. CAUTION Premature weary and malfunctions from improper servicing and care. Reduced production time.
  • Page 45: Care Products And Systems - Servicing: Care With Kavo Spray

    Preparation methods according to ISO 17664 Note KaVo only guarantees that its products will function properly when the care products are used that are listed as accessories since they were tested for proper use on our products. 6.5.1 Care products and systems - Servicing: Care with KaVo Spray...
  • Page 46: Care Products And Systems - Servicing: Care With The Kavo Sprayrotor

    ▶ Place the product on the cannula, and press the spray button for one second. 6.5.2 Care products and systems - Servicing: Care with the KaVo SPRAYr‐ otor KaVo recommends servicing the project twice daily (at noon and in the evening after hours), after each time the machine is cleaned, and before each sterilisation.
  • Page 47: Care Products And Systems - Servicing: Care With Kavo Quattrocare

    TROcare Cleaning and care unit with expansion pressure for effective cleaning and care. KaVo recommends servicing the project twice daily (at noon and in the evening after hours), after each time the machine is cleaned, and before each sterilisation. ▶...
  • Page 48: Packaging

    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 STERIclave bags Mat. no. 0.411.9912)!
  • Page 49: Sterilisation

    Preparation methods according to ISO 17664 6.7 Sterilisation Sterilise in a steam steriliser (Autoclave) EN 13060/ISO 17665-1 CAUTION Premature weary and malfunctions from improper servicing and care. Reduced production time. ▶ Before each sterilisation cycle, treat the medical device with KaVo care products.
  • Page 50 Damage to product ▶ Immediately remove the product from the steam steriliser after the sterilisation cycle! The medical device is temperature resistant up to 138℃ (280.4°F). KaVo recommends for example - STERIclave B 2200/ 2200P by KaVo - Citomat/ K-series by Getinge...
  • Page 51: Storage

    Preparation methods according to ISO 17664 Depending on the device, select a suitable method from the following grav‐ itation methods. Autoclave with a triple pre-vacuum for least four minutes at 134°C ± 1°C (273°F ± 1.8°F) Autoclave using the gravitational method: sterilise for at least 10 min. at 134°C ±...
  • Page 52 Preparation methods according to ISO 17664 Note Observe the expiration date of the sterilized item.
  • Page 53: 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 Nozzle needle 0.410.0921 Sterilisable spray hose 0.065.5188 Drill stop 0.524.0892 Hook 0.410.1963 KaVo CLEANspray 1.007.0579 KaVo DRYspray 1.007.0580...
  • Page 54 Tools Material summary Mat. no, KaVo Spray 2112 A 0.411.9640 ROTAspray 2142 A 0.411.7520 QUATTROcare plus Spray 2108 P 1.005.4525...

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