KaVo GENTLEpower LUX handpiece 10 LP Instructions For Use Manual
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KaVo GENTLEpower LUX handpiece 10 LP Instructions For Use Manual

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Instructions for use
GENTLEpower LUX handpiece 10 LP - 1.001.5660

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Summary of Contents for KaVo GENTLEpower LUX handpiece 10 LP

  • Page 1 Instructions for use GENTLEpower LUX handpiece 10 LP - 1.001.5660...
  • 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 ............................13 Purpose – Intended use ........................14 Technical Specifications ........................16 Transportation and storage conditions ....................
  • Page 4 Table of contents Remove the medical device ......................... 25 Insert the handpiece or contra-angle handpiece drill bit............... 26 Remove the handpiece or contra-angle handpiece drill bit ..............30 Conversion for contra-angle handpiece drill bit ..................31 6 Preparation methods according to ISO 17664 ....................32 Preparations at the site of use ......................
  • Page 5 6.5.1 Care products and systems - Servicing: Care with KaVo Spray ..........45 6.5.2 Care products and systems - Servicing: Care with the KaVo SPRAYrotor ......47 6.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A ............................
  • Page 6 Table of contents 7 Tools and consumables ..........................61 8 Warranty terms and conditions ........................63...

  • 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 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 Hazard from use as a light probe.
  • Page 13 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 14 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 15: Product Description

    Product description 3 Product description GENTLEpower LUX Handpiece 10 LP (Mat. no. 1.001.5660)

  • Page 16: Purpose - Intended Use

    Product description 3.1 Purpose – Intended use Purpose: This medical device is ▪ Only intended for dental treatment. Any other type of use or altera‐ tion to the product is impermissible and can be hazardous. The med‐ ical device is intended for the following uses: Removal of carious ma‐ terial, cavity preparation, removal of fillings, processing of surfaces, and polishing and smoothing tooth and restoration surfaces.
  • Page 17 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 18: Technical Specifications

    Product description 3.2 Technical Specifications Drive speed max. 40,000 rpm identification 1 blue ring Transmission 1 : 1 Maximum speed max. 40,000 rpm Handpiece cutters or grinders can be used. Short handpiece cutters or grinders can be used after conversion.

  • Page 19: 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 20 Product description Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture...

  • Page 21: 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 22: 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 23 Start up and shut down...
  • Page 24 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. 0.410.0921 if necessary.

  • Page 25: Operation

    Operation 5 Operation 5.1 Attach the medical device WARNING Release of the medical device during treatment. 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 26 Operation 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. ▶ Never attach or remove the handpiece while the device is rotating!

  • Page 27: Remove The Medical Device

    Operation ▶ Attach medical device to the motor coupling and turn it until the latch audibly snaps into place. ▶ Pull on the medical device to make sure that it is securely affixed to the coupling. 5.2 Remove the medical device ▶...

  • Page 28: 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 handpieces that correspond to 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 a drill bit stop: - Shaft clamping length: min.
  • Page 29 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 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 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 31 Operation ▶ Rotate the clamping ring all the way in the direction of the arrow, and insert the handpiece cutter or grinder into the chuck. ▶ Turn the clamping ring back into its initial position. ▶ Check that the cutter or grinder is seated by pulling on it.

  • Page 32: Remove The Handpiece Or Contra-Angle Handpiece Drill Bit

    Operation 5.4 Remove the handpiece or contra-angle handpiece 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! ▶ Remove the cutter/grinder from the contra-angle handpiece after treatment to avoid injury and infection when putting it away.

  • Page 33: 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 enclosed drill stop in the chuck. ▶ Press the contra-angle drill bit onto the stop, close the clamping ring, and check for firm seating.

  • Page 34: 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. There is a risk of infection from contaminated medical devices. ▶ Take suitable personal protective measures. ▶...

  • Page 35: Cleaning

    Preparation methods according to ISO 17664 6.2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. ▶ Clean manually or in a thermodisinfector only! 6.2.1 Cleaning: Manual cleaning - external Accessories required: ▪ Tap water 30 °C ± 5 °C (86 °F ± 10 °F) ▪...

  • Page 36: Cleaning: Automated External Cleaning

    Z" and rinsing agent "neodisher miel‐ ® ® clear" and only applies to the material compatibility with KaVo products). ▶ For program settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the thermodisinfec‐...

  • Page 37: 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 spray attachment and let the cleaner work for one minute.

  • Page 38: 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 39 "neodisher mielclear" rinsing agent and applies only to ® the compatibility of materials with KaVo products). ▶ For program settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the thermodisinfector (complying with max.

  • Page 40: Disinfection

    Preparation methods according to ISO 17664 6.3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. Defects in the product. ▶ Disinfect in a thermodisinfector or, without packaging, in an auto‐ clave or manually only!

  • Page 41: Disinfection: Manual Disinfection - External

    Preparation methods according to ISO 17664 6.3.1 Disinfection: Manual disinfection - external KaVo recommends the following products based on compatibility of the materials. The microbiological efficacy must be ensured and demonstra‐ ted by means of an expert report by the disinfectant manufacturer.

  • Page 42: 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 43: Disinfection: Machine Disinfection - External And Internal

    Follow the instructions for use of the disinfectant. 6.3.3 Disinfection: Machine disinfection - external and internal For automatic disinfection, KaVo recommends unwrapped sterilisation in an autoclave at 135 °C (preferably B-class). Alternatively, the disinfection can be carried out using thermodisinfectors in accordance with EN ISO 15883-1, which are operated with alkaline cleaning agents with a pH value of max.

  • Page 44: 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. 6.4 Drying Manual Drying ▶...

  • Page 45: Care Products And Systems - Servicing

    Preparation methods according to ISO 17664 Automatic Drying The drying procedure is usually part of the cleaning program of the ther‐ modisinfector. ▶ Follow the instructions for use of the thermodisinfector. 6.5 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 46 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 47: Care Products And Systems - Servicing: Care With Kavo Spray

    Preparation methods according to ISO 17664 6.5.1 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 48 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 spray nipple tip in the open‐ ing and spray. ▶...

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

    Preparation methods according to ISO 17664 6.5.2 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 50: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare 2104 / 2104A

    Preparation methods according to ISO 17664 6.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A Note QUATTROcare 2104 / 2104 A is no longer available for delivery. Successor products: ▶ QUATTROcare PLUS 2124 A ▶ QUATTROcare CLEAN 2140 A Cleaning and servicing device with expansion pressure for internal clean‐...
  • Page 51 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 52 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 53: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare Plus 2124 A

    (not a validated internal cleaning in accordance with 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 54 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 55 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 56: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare Clean 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 6.5.5 Care products and systems - Servicing: Servicing with KaVo QUATTROcare CLEAN 2140 A Programme-controlled cleaning and servicing device for perfect instru‐...
  • 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. ▶ Service the product in QUATTROcare PLUS.

  • Page 58: Packaging

    Preparation methods according to ISO 17664 6.6 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 59: Sterilisation

    Preparation methods according to ISO 17664 6.7 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 60 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 61: 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 62 Preparation methods according to ISO 17664 Note Comply with the expiry date of the sterilised items.
  • Page 63 Tools and consumables 7 Tools and consumables Available from dental 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 Spray hose, sterilisable 0.065.5188 Drill stop 0.524.0892 Hook 0.410.1963...
  • Page 64 Tools and consumables 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 KaVo Spray 2112 A 0.411.9640 ROTAspray 2 2142 A 0.411.7520 QUATTROcare plus Spray 2140 P 1.005.4525...
  • Page 65 24 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 particu‐...
  • Page 66 Warranty terms and conditions 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 au‐...

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1.001.5660

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