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Related Manuals for KaVo Dental INTRAmatic 14 ES
Summary of Contents for KaVo Dental INTRAmatic 14 ES
- Page 1 Instructions for use INTRAmatic contra-angle 14 ES - REF 1.003.4831...
- 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...
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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 milling cutters or diamond grinders Removing the milling tool or diamond grinder. Preparation methods according to ISO 17664 Preparations at the site of use Cleaning 6.2.1 Cleaning: Manual cleaning - external 6.2.2 Cleaning: Automated external cleaning... -
Page 5: Table Of Contents
Table of contents 6.3.2 Disinfection: Manual disinfection - internal 6.3.3 Disinfection: Machine disinfection - external and internal Drying 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
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.
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Page 8: Warranty Terms And Conditions
User instructions 1.1 Warranty terms and conditions The following warranty conditions apply to this KaVo medical device: KaVo provides the end customer with a warranty of proper function and guarantees zero defects in respect of material and processing for a period of 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. - 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.
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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.
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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: ▪...
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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 Safety Note For safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires. Authorized to repair and service KaVo products: ▪ Technicians at the KaVo branches throughout the world ▪ 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‐...
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Page 17: Product Description
Product description 3 Product description INTRAmatic contra-angle handpiece 14 ES (Mat. no. 1.003.4831) 3.1 Technical Specification Drive speed identification 1 green ring Transmission 4 : 1... - Page 18 Product description With pushbutton chuck. Short handpiece cutters or grinders can be used. The contra-angle handpiece can be mounted on all INTRAmatic (LUX) mo‐ tors, and motors with a connection in accordance with ISO 3964 / DIN 13940.
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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...
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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. 0.410.0931 if necessary.
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Page 23: Operation
Operation 5 Operation 5.1 Attach the medical device 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 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.
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Page 25: Remove The Medical Device
Operation ▶ Place the medical device on the (LUX) motor coupling and lock it into place. ▶ Before each treatment, pull on the medical device to see if it is securely seated in the motor coupling. 5.2 Remove the medical device ▶... -
Page 26: Insert The Milling Cutters Or Diamond Grinders
Operation 5.3 Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond drill bits that correspond to 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 - Overall length: max. - Page 27 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 28 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 29 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.
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Page 30: 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 the cutter or grinder when it is rotating! ▶ Never press the pushbutton while the cutter or grinder is rotating! ▶... - Page 31 Operation ▶ After the cutter or grinder has stopped rotating, press the push button with your thumb and pull out the cutter or grinder.
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Page 32: 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 33: 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 34: 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 (Validation was performed with the program "VARIO-TD", the cleaner "ne‐ odisher mediclean", the neutraliser "neodisher Z"... -
Page 35: Cleaning: Manual Cleaning - Internal
Preparation methods according to ISO 17664 ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector. ▶ Directly after automated cleaning, treat the medical device with the care products and systems provided by KaVo. -
Page 36: 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. In other countries,only automated interior cleaning with thermodisinfectors in accordance with ISO 15883-1. - Page 37 Preparation methods according to ISO 17664 (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 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.
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Page 38: 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 39: 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 40: Disinfection: Manual Disinfection - Internal
Preparation methods according to ISO 17664 ▶ 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. Note Observe the instruction for use for the disinfectant. 6.3.2 Disinfection: Manual disinfection - internal To effectively set up, the inside of the machine must be cleaned automat‐... - Page 41 Preparation methods according to ISO 17664 e.g. Miele G 7781/G 7881 (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 the material compatibility with KaVo products.) ▶...
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Page 42: 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 43: 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 44: 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 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 45: Care Products And Systems - Servicing: Care With The Kavo Sprayrotor
Preparation methods according to ISO 17664 ▶ 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 46: Care Products And Systems - Servicing: Care With Kavo Quattrocare
Preparation methods according to ISO 17664 6.5.3 Care products and systems - Servicing: Care with KaVo QUAT‐ 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 47: Packaging
Preparation methods according to ISO 17664 6.6 Packaging Note The sterilisation bag must be large enough for the instrument 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 48: 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 49 Preparation methods according to ISO 17664 CAUTION Contact corrosion from moisture. 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...
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Page 50: 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 51 Preparation methods according to ISO 17664 Note Observe the expiration date of the sterilized item.
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Page 52: Tools
Tools 7 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 0.410.0931 Silicone hose 150 mm 0.593.0252 KaVo CLEANspray 1.007.0579 KaVo DRYspray 1.007.0580... - Page 53 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...