KaVo INTRA Micro head L22 Instructions For Use Manual
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KaVo INTRA Micro head L22 Instructions For Use Manual

KaVo INTRA Micro head L22 Instructions For Use Manual

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Instructions for use
INTRA Micro head L22 – 1.008.1835

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Summary of Contents for KaVo INTRA Micro head L22

  • Page 1 Instructions for use INTRA Micro head L22 – 1.008.1835...
  • Page 2 Distributed by: Manufacturer: KaVo Dental GmbH KaVo Dental GmbH Bismarckring 39 Bismarckring 39 88400 Biberach 88400 Biberach Germany Germany Phone +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...

  • Page 3: Table Of Contents

    Table of contents 3 / 82 Table of contents 1 User instructions......................... 2 Safety..........................2.1 Infection hazard ......................18 2.2 Improper use ......................... 19 2.3 Technical condition ......................21 2.4 Accessories and combination with other equipment............23 2.5 Qualification of personnel ....................24 2.6 Service and repair......................
  • Page 4 Table of contents 4 / 82 3.2 Technical Specifications ....................31 3.3 Transportation and storage conditions ................32 4 Startup and shut down ....................... 4.1 Checking the amount of water ..................36 5 Operation ..........................5.1 Attaching the medical device ................... 38 5.2 Removing the medical device...................
  • Page 5 Table of contents 5 / 82 6.2 Troubleshooting......................51 6.2.1 Replacing the O-rings on the motor coupling ............53 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2....... 7.1 Preparations at the site of use..................54 7.2 Manual reprocessing ....................... 58 7.2.1 Manual pre-cleaning ....................
  • Page 6 7.3.2 Automated internal and external cleaning and internal and external disinfection..68 7.3.3 Automated drying ....................69 7.4 Care products and systems - Servicing ................70 7.4.1 Servicing with KaVo Spray ..................71 7.4.2 Servicing with KaVo QUATTROcare PLUS..............72 7.5 Packaging ........................73 7.6 Sterilisation........................

  • Page 7: User Instructions

    7 / 82 1 User instructions Dear user, Congratulations on purchasing this KaVo quality product. By following the notes below you will be able to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH INTRA is a registered trademark of KaVo Dental GmbH.
  • Page 8 1 User instructions 8 / 82 KaVo Original Factory Repair In the event of a repair, please ship your product to the KaVo Original Factory Re- pair using www.kavobox.com.
  • Page 9 1 User instructions 9 / 82 KaVo Technical service If you have any technical questions or complaints, please contact the KaVo Tech- nical service: +49 (0) 7351 56-1000 service.instrumente@kavo.com Target group The instructions for use are intended for medical professionals, in particular dent- ists and dental practice personnel.
  • Page 10 1 User instructions 10 / 82 General marks and symbols See chapter on user instructions/hazard levels Important information for users and service technicians Action request CE- mark (European Community). A product bearing this mark meets the requirements of the applicable EC directives.
  • Page 11 1 User instructions 11 / 82 Medical device, labelling of medical devices Sterilisable by steam Thermodisinfectable Information on the packaging Material number...
  • Page 12 1 User instructions 12 / 82 Serial number Manufacturer UDI symbol Note: Please note accompanying documents Follow the electronic instructions for use...
  • Page 13 1 User instructions 13 / 82 HIBC Code CE mark for medical devices EAC conformity mark (Eurasian Conformity) Medical device, labelling of medical devices...
  • Page 14 1 User instructions 14 / 82 UA Mark of conformity Transportation and storage conditions (temperature range) Transportation and storage conditions (air pressure) Transportation and storage conditions (Humidity)
  • Page 15 1 User instructions 15 / 82 Protect from moisture (Keep dry) Protect from impact Original language German Hazard levels The warning and safety notes in this document must be observed to prevent per- sonal injury and material damage. The warning notes are designated as shown below:...
  • Page 16 1 User instructions 16 / 82 HAZARD In cases which – if not prevented – directly lead to death or severe injury. WARNING In cases which – if not prevented – can lead to death or severe injury. CAUTION In cases which – if not prevented – can lead to minor or moderate injury. CAUTION In cases which –...

  • Page 17: Safety

    2 Safety 17 / 82 2 Safety NOTE All serious events occurring in relation to the product must be reported to the manufacturer and the competent authority of the member state, in which the user and/or patient resides. The instructions for use are an integral part of the product and must be read care- fully prior to use and must be accessible at all times.

  • Page 18: Infection Hazard

    2 Safety 18 / 82 2.1 Infection hazard Patients, users or third parties could be infected by contaminated medical devices. 4 Take suitable personal protective measures. 4 Follow the instructions for use of the components. 4 Before initial startup and after each use, reprocess the product and accessor- ies appropriately.

  • Page 19: Improper Use

    2 Safety 19 / 82 4 Use gloves or a finger guard when you test, insert and remove the dental tool. 2.2 Improper use Because the operation with an electric motor involves a higher torque, patients, users and other people can suffer injuries and serious burns if an instrument is damaged or used improperly.
  • Page 20 2 Safety 20 / 82 4 Use an appropriate light probe for illumination of the oral cavity or site of pre- paration. 4 Do not operate the medical device at eye level.

  • Page 21: Technical Condition

    2 Safety 21 / 82 2.3 Technical condition A damaged product or damaged or NOT KaVo original components could injure patients, users or third parties. 4 Only operate devices or components if they show no signs of damage on the outside.
  • Page 22 2 Safety 22 / 82 • Irregular running noise • Excessive vibration • Overheating • Dental tool is not seated firmly in the handpiece To ensure optimum function and to prevent property damage, please comply with the following instructions: 4 Service the medical device regularly with care products and systems as de- scribed in the instructions for use.

  • Page 23: Accessories And Combination With Other Equipment

    4 Only use accessories that have been approved for combination with the product by the manufacturer. 4 Only combine with approved KaVo shanks. 4 Only use accessories that are equipped with standardised interfaces. 4 Do not make any modifications to the device unless these have been ap-...

  • Page 24: Qualification Of Personnel

    2 Safety 24 / 82 4 Use original KaVo spare parts only. The lack of control equipment for changing the speed range and the direction of rotation can lead to injury. 4 Control equipment for changing the speed and the direction of rotation must be present.

  • Page 25: Service And Repair

    Repairs, servicing and safety checks may only be performed by trained service personnel. The following persons are authorised to do this: • Service technicians of KaVo branches after the appropriate product training • Service technicians of KaVo authorised dealers after the appropriate product...
  • Page 26 Define the service interval depending on the frequency of use. As a result of the use of NON-KaVo original spare parts during the repair, parts may become detached and injure patients, users or third parties. This may result in aspiration, swallowing of parts and possibly even a risk of suffocation.
  • Page 27 27 / 82 NOTE If a repair is done with NON-KaVo original spare parts, this may constitute a product modification that leads to the loss of CE conformity. In the event of damage, the responsibility is with the service company or the operator.

  • Page 28: Product Description

    3 Product description 28 / 82 3 Product description INTRA Micro head L22 (Mat. no. 1.008.1835) 3.1 Intended use Indications for use: The medical device is:...
  • Page 29 3 Product description 29 / 82 • Intended for dental treatment only. All other types of use of or modifications to the product are not permitted and can be hazardous. • The medical device is intended for the following applications: –...
  • Page 30 • compliance with the specified intended use. • Protect themselves, patients and third parties from danger. • Contamination by the product must be avoided. NOTE Read and take note of Instructions for use of the KaVo shanks in which the head can be inserted.

  • Page 31: Technical Specifications

    31 / 82 3.2 Technical Specifications Drive speed max. 20,000 rpm Speed transmission 1 : 1 Drill change Changing of dental burs with special tool Insert KaVo round drill and KaVo inverted cone bur Can be attached to All KaVo shanks...

  • Page 32: Transportation And Storage Conditions

    3 Product description 32 / 82 3.3 Transportation and storage conditions CAUTION Startup after refrigerated storage. Malfunction. 4 Prior to startup, strongly refrigerated products must be allowed to warm up to a temperature of 20 °C to 25 °C (68 °F to 77 °F). Temperature: -29 °C to +50 °C (-20 °F to +122 °F)
  • Page 33 3 Product description 33 / 82 Relative humidity: 5% RH to 85% RH absence of condensation Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture (Keep dry)

  • Page 34: Startup And Shut Down

    4 Startup and shut down 34 / 82 4 Startup and shut down WARNING Hazard from contaminated products. Patients, users or third parties could be infected by contaminated medical devices. 4 Prior to initial startup and after each use, reprocess the product and accessor- ies.
  • Page 35 Dispose of and recycle the packaging appropriately in accordance with current packaging law, employing waste management / recycling companies. Comply with the comprehensive return system. KaVo has had its packaging licensed for this purpose. Please comply with the regional public waste-disposal system.

  • Page 36: Checking The Amount Of Water

    4 Startup and shut down 36 / 82 4.1 Checking the amount of water CAUTION Overheating of the tooth due to insufficient amount of cooling water. Insufficient spray water can cause the medical device to overheat and damage the pulp and tooth. 4 Adjust the water flow for the spray cooling to a minimum of 50 mL/min (3.1 inch...

  • Page 37: Operation

    5 Operation 37 / 82 5 Operation WARNING Rotating dental tool. Cuts, infection and burn injury. 4 Do not touch the dental tool while it is rotating. 4 Never contact soft tissue with the instrument head. NOTE At the beginning of each workday, the water-conducting systems should be rinsed for at least 2 minutes (without transmission handpieces being attached) and if there is a risk of contamination from reflux or back suction, the system may also need to be rinsed for 20 to 30 seconds after each patient.

  • Page 38: Attaching The Medical Device

    5 Operation 38 / 82 5.1 Attaching the medical device WARNING Detaching the medical device during treatment. If the head is not properly locked in place, it can become detached during treat- ment. 4 Do not mount or remove the head while it is rotating. 4 By pulling, check that the head is firmly seated and that the clamping ring is tightly fixed prior to every treatment.

  • Page 39: Removing The Medical Device

    5 Operation 39 / 82 4 Rotate the clamping ring in the opposite direction and tighten it. 5.2 Removing the medical device 4 Rotate the clamping ring in the direction of the arrow until it hits the stop and hold it there. 4 Removing the medical device.
  • Page 40 5 Operation 40 / 82 - Round drill size 0 blade diameter: 0.9 mm (Mat. no. 0.549.0042) - U inverted cone bur size 2 blade diameter: 1.1 mm (Mat. no. 0.549.0062) - U inverted cone bur size 0 blade diameter: 0.9 mm (Mat.
  • Page 41 5 Operation 41 / 82...
  • Page 42 5 Operation 42 / 82 WARNING Use of unauthorised dental burs. Injury to the patient or damage to the medical device. 4 Only use dental burs that do not deviate from the specified data. CAUTION Do not use damaged dental tools. Risk of injury from swallowing a dental tool that falls out.
  • Page 43 5 Operation 43 / 82 CAUTION Contaminated, sharp-edged dental tool. Patients, users or third parties could be infected by contaminated medical devices. 4 Use gloves or a finger guard when you test, insert and remove the dental tool. CAUTION Defective chuck system. Injury hazard, dental tool may fall out during treatment.
  • Page 44 5 Operation 44 / 82 CAUTION Hazard to patients. Set the direction of rotation of the round drill to clockwise only. 4 The blades work in clockwise rotation only.
  • Page 45 5 Operation 45 / 82 CAUTION Dental tool shaft slips inside the chucking system due to excessive speed of the dental tool or abrupt engagement of the dental tool. Material damage to dental tool shaft and chuck system, reduction of the service life of dental tool and chuck system.
  • Page 46 5 Operation 46 / 82 4 Insert the round drill or the inverted cone bur ② into the head housing. 4 Position the bearing cover ③ and tighten with screwdriver ④ and torque wrench with 22 Ncm in the direction of the arrow. 4 Check functioning by turning the knob ①.

  • Page 47: Removing The Dental Bur

    5 Operation 47 / 82 5.4 Removing the dental bur WARNING Rotating dental tool. Cuts, infection and burn injury. 4 Do not touch the dental tool while it is rotating. 4 Never contact soft tissue with the instrument head.
  • Page 48 5 Operation 48 / 82 4 Loosen the bearing cover ③ with screwdriver ④. 4 Remove the round drill or inverted cone bur ② from the head housing in the direction of the arrow, while turning the knob ① gently.

  • Page 49: Checking For Malfunctions And Troubleshooting

    6 Checking for malfunctions and troubleshooting 49 / 82 6 Checking for malfunctions and troubleshooting 6.1 Checking for malfunctions CAUTION Overheating of the device. Burns or product damage from overheating. 4 If the device overheats, stop working and have the service personnel repair the device.
  • Page 50 6 Checking for malfunctions and troubleshooting 50 / 82 4 If the medical device overheats while idling, check the cooling air flow. 4 If the medical device overheats when exposed to load, the medical device needs to be serviced. 4 When the speed drops or is uneven, the medical device needs to be serviced. 4 If there is no O-ring on the motor coupling, replace the O-ring.

  • Page 51: Troubleshooting

    6.2 Troubleshooting NOTE If a repair is done with NON-KaVo original spare parts, this may constitute a product modification that leads to the loss of CE conformity. In the event of damage, the responsibility is with the service company or the operator.
  • Page 52 6 Checking for malfunctions and troubleshooting 52 / 82 WARNING Repair WITHOUT using KaVo original spare parts. Parts could come loose and cause injury. Aspiration, swallowing of parts and danger of suffocation. 4 Only use spare parts that comply with the specification for repair; original...

  • Page 53: Replacing The O-Rings On The Motor Coupling

    Malfunction or complete failure. 4 Do not use Vaseline or other grease or oil. 4 Spray a lint-free cloth with KaVo Spray and apply it to the O-rings on the coupling. 4 Press the O-ring between your fingers to form a loop.

  • Page 54: Reprocessing Steps In Accordance With Iso 17664-1 / Iso 17664-2

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 54 / 82 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 7.1 Preparations at the site of use WARNING Hazard from contaminated products. Patients, users or third parties could be infected by contaminated medical devices. 4 Take suitable personal protective measures.
  • Page 55 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 55 / 82 WARNING Sharp dental tool in the medical device. Injury hazard from sharp and/or pointed dental tool. 4 Remove the dental tool. 4 To minimise the risk of infection during reprocessing, always wear protective gloves.
  • Page 56 Malfunction and material damage. 4 Reprocess in a washer disinfector or by hand only. KaVo recommends the following products based on the compatibility of the mater- ials. The microbiological efficacy must be ensured by the disinfectant manufacturer and proven by an expert opinion.
  • Page 57 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 57 / 82 4 Spray the disinfectant on a cloth, then wipe down the medical device and al- low the disinfectant to act according to the instructions of the disinfectant manufacturer.

  • Page 58: Manual Reprocessing

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 58 / 82 7.2 Manual reprocessing WARNING Incomplete disinfection. Patients, users or third parties could be infected by contaminated medical devices. 4 Only use disinfection procedures that are verified to be bactericidal, fungicidal and virucidal.
  • Page 59 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 59 / 82 CAUTION Never reprocess the medical device with chloride-containing products. Malfunction and material damage. 4 Reprocess in a washer disinfector or by hand only. CAUTION Never reprocess this medical device in an ultrasonic cleaner. Malfunction and material damage.

  • Page 60: Manual Pre-Cleaning

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 60 / 82 NOTE Before reprocessing, attach the head to the shank. The round drill or inverted cone bur also stays in the head during reprocessing. 7.2.1 Manual pre-cleaning 4 Rinse the instrument for 20 seconds with process water on the treatment centre.
  • Page 61 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 61 / 82 4 Rinse through the instrument for at least 3 x 2 seconds (solution must flow out visibly). 4 Take the instrument from the adapter and set it down. 4 Spray the surface of the instrument with CLEANspray until the entire surface is wet.

  • Page 62: Manual Internal And External Cleaning And Internal And External Disinfection

    • Brush, e.g. medium-hard toothbrush 4 Brush off under flowing tap water at least 10 seconds. Cleaning with KaVo CLEANspray (internal and external) Carry out non-protein-fixing internal cleaning with a CLEANspray and external cleaning with a cloth soaked with CLEANspray: 4 Attach fitting adapter to the CLEANspray can.
  • Page 63 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 63 / 82 4 Rinse through the instrument for at least 3 x 2 seconds (solution must flow out visibly). 4 Take the instrument from the adapter and set it down. 4 Spray the surface of the instrument with CLEANspray until the entire surface is wet.

  • Page 64: Manual Drying

    7.2.3 Manual drying Use KaVo DRYspray for subsequent drying of the air, water and gear unit ducts. 4 Cover the medical device with the KaVo Cleanpac bag, and place it on the corresponding care adapter. 4 Hold the can vertically.
  • Page 65 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 65 / 82 Also refer to: Instructions for use KaVo DRYspray 4 Immediately after drying, lubricate the KaVo medical device with care agents from the KaVo care system. Also refer to: 7.4 Care products and systems - Servicing, Page 70...

  • Page 66: Automated Reprocessing

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 66 / 82 7.3 Automated reprocessing CAUTION Never reprocess the medical device with chloride-containing products. Malfunction and material damage. 4 Reprocess it in a washer disinfector only. CAUTION Never reprocess this medical device in an ultrasonic cleaner. Malfunction and material damage.

  • Page 67: Pre-Cleaning

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 67 / 82 NOTE Before reprocessing, attach the head to the shank. The round drill or inverted cone bur also stays in the head during reprocessing. 7.3.1 Pre-cleaning Accessories required: •...

  • Page 68: Automated Internal And External Cleaning And Internal And External Disinfection

    68 / 82 7.3.2 Automated internal and external cleaning and internal and external disinfection KaVo recommends washer disinfectors in accordance with EN ISO 15883-1, which are operated using alkaline cleaning agents. The validations were performed using a Miele washer disinfector and the "VARIO-TD"...

  • Page 69: Automated Drying

    NOTE Please comply with the instructions for use of the washer disinfector. 4 In order not to affect the KaVo medical device, make sure that the product is dry on the inside and outside after completion of the cycle. 4 Remove any residual liquids with KaVoDRYspray.

  • Page 70: Care Products And Systems - Servicing

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 70 / 82 4 Immediately after drying, lubricate the KaVo medical device with care agents from the KaVo care system. 7.4 Care products and systems - Servicing CAUTION Improper service and care.

  • Page 71: Servicing With Kavo Spray

    71 / 82 NOTE KaVo guarantees the proper function of KaVo products only if the care products listed by KaVo as accessories are used, since these were tested for proper use on our products. 7.4.1 Servicing with KaVo Spray NOTE Head can be serviced alone or attached to a shank.

  • Page 72: Servicing With Kavo Quattrocare Plus

    72 / 82 4 Remove the dental tool from the medical device. 4 Cover the medical device with the KaVo Cleanpac bag, and place it on the corresponding care adapter. 4 Press the spray key for 1 to 2 seconds.

  • Page 73: Packaging

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 73 / 82 4 Service the device in the QUATTROcare PLUS. Also refer to: Instructions for use KaVo QUATTROcare PLUS 7.5 Packaging NOTE The sterile goods package must be large enough to accommodate the product without stretching the packaging.

  • Page 74: Sterilisation

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 74 / 82 7.6 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with EN 13060 / EN ISO 17665-1 CAUTION Improper service and care. Risk of injury. 4 Service regularly with suitable agents.
  • Page 75 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 75 / 82 CAUTION Contact corrosion due to moisture. Damage to product. 4 Immediately remove the product from the steam steriliser after the sterilisa- tion cycle. The medical device has a max. temperature resistance of up to 138 C (280.4 Sterilisation parameters: Select a suitable process from the following sterilisation processes (depending on...

  • Page 76: Storage

    7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 76 / 82 • Steriliser with triple pre-vacuum: – at least 3 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 • Steriliser using the gravity method: –...
  • Page 77 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 77 / 82 NOTE Comply with the expiry date of the sterilised items.

  • Page 78: Optional Aids And Consumables

    Available from specialised dental dealers. Material summary Mat.No. INTRA Instrument stand 3.005.5204 Service coupling for heads (QUATTROcare) 0.411.7941 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 KaVo CLEANspray 2110 P 1.007.0579 KaVo DRYspray 2117 P 1.007.0580 KaVo Spray 2112 A 0.411.9640...
  • Page 79 8 Optional aids and consumables 79 / 82 Material summary Mat.No. Spray head INTRA (incl. nipple) 0.411.9911 Chuck servicing set 1.003.1253 Adapter INTRAmatic 1.007.1776 QUATTROcare plus Spray 2140 P 1.005.4525 Screwdriver 1.008.5493 Torque handle 22 Ncm 1.003.1523 Universal bit holder 1.002.4577...

  • Page 80: Terms And Conditions Of Warranty

    24 months from the date of the invoice, subject to the following conditions: With regard to justified complaints KaVo grants warranty in the form of a free of charge repair or delivery of a replacement. Other claims of any kind whatsoever, in particular with respect to compensation, are excluded.
  • Page 81 Any liability is excluded if defects or the consequences thereof are due to the cus- tomer or third parties not authorized by KaVo interfering with or modifying the product. Warranty claims can only be asserted if proof of sale in the form of a copy of the invoice or delivery note is presented with the product.

This manual is also suitable for:

1.008.1835

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