KaVo INTRA 3610 N3 Instructions For Use Manual
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KaVo INTRA 3610 N3 Instructions For Use Manual

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Instructions for use
INTRA surgical handpiece 3610 N3 - REF
0.524.5620

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Summary of Contents for KaVo INTRA 3610 N3

  • Page 1 Instructions for use INTRA surgical handpiece 3610 N3 - REF 0.524.5620...
  • Page 2 Sales: 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

    Contents Contents Contents User instructions Warranty terms and conditions Safety Description of safety instructions Purpose – Proper use Safety instructions Product description Technical data Transportation and storage conditions First use Cooling medium supply...

  • Page 4: Contents

    Contents Operation Attach the medical device Remove the medical device Insert the milling cutters or diamond grinders Removing the milling tool or diamond grinder Conversion for short handpiece cutters or grinders Preparation methods according to ISO 17664 Preparations at the site of use Disassemble the medical device Assembling the medical device Cleaning...

  • Page 5: Contents

    6.5.3 Disinfection: Machine disinfection - external and internal Drying Care products and systems - Servicing 6.7.1 Care products and systems - Servicing: Care with KaVo Spray 6.7.2 Care products and systems - Servicing: Care with KaVo QUATTROcare Packaging Sterilization 6.10...

  • Page 6: User Instructions

    User instructions 1 User instructions Dear user, KaVo hopes that you enjoy your new high-quality product. Following the instructions below will allow you to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH Symbols See the section Safety/Warning Symbols...
  • Page 7 User instructions Disinfectable with heat Sterilizable 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

    24 months from data of invoice, subject to the following conditions: In case of justified complaints, KaVo will honour its warranty with a repair or free replacement. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded.
  • Page 9 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. 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 describes the possible consequences of misuse. ▶ The optional step contains necessary measures for avoiding haz‐ ards.
  • Page 11 Safety Description of hazardous steps 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 lead to property damage or minor to moderate injury. WARNING WARNING indicates a hazardous situation that can lead to serious injury or death.

  • Page 12: Purpose - Proper Use

    Safety DANGER DANGER indicates a maximum hazardous situation that can directly cause serious injury or death. 2.2 Purpose – Proper use This medical device is ▪ only for dental treatment by a dental professional. The product may not be changed or used for any other purpose since this may be hazard‐ ous.
  • 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. Shortened product life. ▶ 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 Safety Service may only be provided by repair shops that have undergone training by KaVo and that use original KaVo replacement parts.

  • Page 18: Product Description

    Product description 3 Product description INTRA surgical handpiece 3610 N3 (Mat. no. 0.524.5620) 3.1 Technical data Drive speed max. 40,000 rpm Identification 1 blue ring Transmission Maximum speed max. 40,000 rpm...
  • Page 19 Product description The INTRA surgical handpiece 3610 N3 can be disassembled. See also: 4 First use, Page 22 Handpiece cutters or grinders can be inserted. After conversion, short handpiece cutters or grinders can be inserted. The handpiece can be mounted on all INTRAmatic Lux motors, and motors with a connection in accordance with ISO 3964 / DIN 13940.

  • Page 20: Transportation And Storage Conditions

    Product description 3.2 Transportation and storage conditions CAUTION Starting up the medical device can be hazardous after it has been stored in an excessively cold location. The medical device can malfunction. ▶ Prior to start-up, very cold products must be heated to a temperature of 20 °C (68 °F) to 25 °C (77 °F).
  • Page 21 Product description Air pressure: 700 hPa (10 psi) to 1060 hPa (15 psi) Protect from moisture.

  • Page 22: First Use

    First use 4 First use WARNING Hazard from unsterile products. Infection hazard to the dentist and patient. ▶ Sterilize the medical device before initial use and after each treat‐ ment.

  • Page 23: Cooling Medium Supply

    First use 4.1 Cooling medium supply CAUTION Hazard of air embolism and skin emphysema The insufflation of irrigation in open wounds in the surgical area can cause air embolisms and skin emphysema. ▶ Avoid the insufflation of irrigation in open wounds in surgical area! ▶...
  • Page 24 First use ▶ Do not use a different coolant.

  • Page 25: Operation

    Operation 5 Operation 5.1 Attach the medical device CAUTION Connection with the drive motor. Lock the handpiece. ▶ Only start the hand piece when the chuck is closed. CAUTION Removing and attaching the handpiece while the device is rotating. Damage to the catch. ▶...
  • Page 26 Operation WARNING Release of the medical device during treatment. A medical device that is not properly locked in place can release from the supply hose. ▶ Carefully pull on it before each treatment to ensure that the medical device is securely locked on the supply hose. ▶...

  • Page 27: Remove The Medical Device

    Operation ▶ Pull on it to make sure that the medical device is securely affixed to the coupling. 5.2 Remove the medical device ▶ Unlock the medical device from the motor coupling and remove it, or pull it off by twisting it slightly on its axis.

  • Page 28: Insert The Milling Cutters Or Diamond Grinders

    Operation 5.3 Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond grinders that correspond to ISO 1797-1 type 3, are made of steel or hard metal and meet the following criteria: - shaft diameter: 2.334 to 2.350 mm without drill stop - Overall length: max.
  • Page 29 Operation WARNING Use of impermissible cutters or grinders. Injury to the patient or damage to the medical device. ▶ Observe instructions for use, and use the cutter or grinder properly. ▶ Only use cutters or grinders that do not deviate from the indicated data.
  • Page 30 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 damage. ▶ Pull on the cutter or grinder to check if the chucking system is okay and the cutter or grinder is securely held.
  • Page 31 Operation ▶ Rotate the grip sleeve all the way in the direction of the arrow, and insert the handpiece cutter or grinder into the chuck. ▶ Turn the grip sleeve back into its initial position. ▶ Check that the cutter or grinder is seated by pulling on it.

  • Page 32: Removing The Milling Tool Or Diamond Grinder

    Operation 5.4 Removing the milling tool or diamond grinder WARNING Hazard from rotating cutter or diamond grinder. Lacerations and damage to the chucking system. ▶ Do not touch rotating cutters or grinders! ▶ Never press the pushbutton while the cutter or grinder is rotating! ▶...

  • Page 33: Conversion For Short Handpiece Cutters Or Grinders

    Operation ▶ After the cutter or grinder has stopped rotating, turn the grip sleeve all the way in the direction of the arrow, and remove the cutter or grinder. ▶ Turn the grip sleeve back into its initial position. 5.5 Conversion for short handpiece cutters or grinders Note The handpiece must be converted when short cutters or grinders are used.
  • Page 34 Operation ▶ Remove the drill stop using the accompanying hook.

  • Page 35: 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 CAUTION Hazard from nonsterile products. An infection hazard exists from contaminated medical devices. ▶ Observe suitable personal protective measures. Note After each operation, immediately disassemble the medical device and clean it thoroughly to prevent malfunctions.

  • Page 36: Disassemble The Medical Device

    Preparation methods according to ISO 17664 ▶ The medical device must be dry when transporting it to be prepared. (Do not place it in a solution or the like). ▶ Prepare the medical device directly before treatment. ▶ Remove cutters or burs from the medical device. 6.2 Disassemble the medical device ▶...

  • Page 37: Assembling The Medical Device

    Preparation methods according to ISO 17664 6.3 Assembling the medical device ▶ Place the grip sleeve ① on the sleeve ② and snap it into place. 6.4 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. ▶...

  • Page 38: Cleaning: Automated External Cleaning

    For a medical device with 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 spray attachment and let the cleaner work for one minute.

  • Page 39: Cleaning: Automated Internal Cleaning

    Preparation methods according to ISO 17664 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‐ bourg, Belgium, Netherlands, United Kingdom, Denmark, Sweden, Fin‐ land and Norway.
  • Page 40 (Validation was performed with the program "VARIO-TD", the cleaner "ne‐ odisher® mediclean", the neutraliser "neodisher® Z" and rinse "neodisher® mielclear") and only refers to 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 41: Disinfection

    Preparation methods according to ISO 17664 6.5 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 42: 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. ▪ CaviCide by Metrex...

  • Page 43: Disinfection: Manual Disinfection - Internal

    Preparation methods according to ISO 17664 Required tools: ▪ 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 44: Disinfection: Machine Disinfection - External And Internal

    Preparation methods according to ISO 17664 6.5.3 Disinfection: Machine disinfection - external and internal KaVo recommends thermodisinfectors in accordance with ISO 15883-1 e.g. Miele G 7781/G 7881. ▶ The program settings and cleansers and disinfectants that need to be used can be found in the instructions for use for the thermodisinfector.

  • Page 45: Care Products And Systems - Servicing

    Preparation methods according to ISO 17664 Machine drying The drying process is usually part of the cleaning program of the thermo‐ disinfector. 6.7 Care products and systems - Servicing CAUTION Sharp cutters or grinders in the medical device. Injury hazard from sharp and/or pointed cutters or grinders. ▶...
  • Page 46 Premature wear and malfunctions from improper servicing and care. Shortened product life. ▶ Regularly perform proper care. 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.

  • Page 47: 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 twice daily (at noon and in the evening after hours), after each time the machine is cleaned, and before each sterilisation.
  • Page 48 Preparation methods according to ISO 17664 Chuck care KaVo recommends cleaning and maintaining the chucking system every evening. ▶ Remove the cutter or grinder, place the spray nipple tip in the opening and spray.

  • Page 49: Care Products And Systems - Servicing: Care With Kavo Quattrocare

    6.7.2 Care products and systems - Servicing: Care with KaVo QUAT‐ TROcare Cleaning and care unit with expansion pressure for thorough 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 sterilization.
  • Page 50 Preparation methods according to ISO 17664 ▶ Remove the cutter or grinder. ▶ Servicing the product. Chuck care KaVo recommends cleaning and maintaining the chucking system once a week. See also: Instructions for use KaVo QUATTROcare.
  • Page 51 Preparation methods according to ISO 17664 ▶ Remove the cutter or grinder, place the spray nipple tip in the opening and spray. ▶ Subsequently treat with the care products and systems listed below.

  • Page 52: Packaging

    Preparation methods according to ISO 17664 6.8 Packaging Note The sterilization bag must be large enough for the instrument so that the package is not taut. The quality and use of the sterilized product packaging must satisfy ap‐ plicable standards and be suitable for the sterilization procedure. ▶...

  • Page 53: Sterilization

    Preparation methods according to ISO 17664 6.9 Sterilization Sterilize in a steam sterilizer (Autoclave) EN 13060/ISO 17665-1 CAUTION Premature weary and malfunctions from improper servicing and care. Reduced production time. ▶ Before each sterilization cycle, treat the medical device with KaVo care products.
  • Page 54 Preparation methods according to ISO 17664 CAUTION Contact corrosion from moisture. Damage to product ▶ After the sterilization cycle, immediately remove the product from the Steam sterilizer . The medical device has a maximum temperature resistance up to 138℃ (280.4°F). Autoclave with prevacuum for at least 4 minutes at 134°C ±...

  • Page 55: Storage

    Preparation methods according to ISO 17664 Autoclave using the gravitation method for at least 10 minutes at 134°C ± 1°C (273°F ± 1.8°F) Drying time: 30 min. Autoclave using the gravitation method for at least 60 minutes at 121 °C ± 1°C (250 °F ± 1.8°F) Drying time: 30 min.

  • Page 56: Tools

    Available 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 0.410.0931 Spray hose, sterilisable 0.065.5188 Drill stop 0.524.0892 Hook 0.410.1963 KaVo CLEANspray 1.007.0579 KaVo DRYspray 1.007.0580...
  • Page 57 Tools Only for the USA Material summary Mat. no. KAVOspray America 2113 A 0.411.9660 QUATTROcare plus Spray America 1.005.4524 2141 P...

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0.524.5620

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