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Related Manuals for KERR ENDODONTICS elements 8:1
Summary of Contents for KERR ENDODONTICS elements 8:1
- Page 1 Instructions for use elements™ 8:1...
- Page 2 Manufactured for: Distributed by: Kerr Corporation Kerr Australia Pty. Limited 1717 West Collins Avenue Unit 6, 12 Mars Road Orange CA 92867 Lane Cove West, New South Wales 2066 U.S.A. Australia +1-800-KERR-123 +61-2-8870-3000 www.kerrdental.com Manufacturer: Importer KaVo Dental GmbH Ormco B.V. Bismarckring 39 Basicweg 20 NL-3821 BR 88400 Biberach...
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Page 3: Table Of Contents
Instructions for use elements™ 8:1 Table of contents Table of contents 1 User instructions ........................ 4 2 Safety..........................7 2.1 Infection hazard ......................7 2.2 Improper use ........................ 7 2.3 Technical condition ......................7 2.4 Accessories and combination with other equipment............8 2.5 Qualification of personnel .................... -
Page 4: User Instructions
Kerr Endodontics product. By following the instructions below you will be able to work smoothly, economically and safely. KaVo and elements 8:1 are either registered trademarks or trademarks of KaVo Dental GmbH. All other trademarks are property of their respective owners. - Page 5 Instructions for use elements™ 8:1 1 User instructions Temperature range Air pressure Relative humidity Caution: Federal (US) law restricts the sale of the device by or on the only order of a dentist. CE mark (European Conformity mark) Medical device, labeling of medical devices Importer Transport upright with the arrows pointing upwards! Fragile - protect against impact!
- Page 6 Instructions for use elements™ 8:1 1 User instructions CAUTION In cases which – if not prevented – can lead to minor or moderate in- jury. NOTICE In cases which – if not prevented – can lead to property damage. 6 / 30...
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Page 7: Safety
Instructions for use elements™ 8:1 2 Safety | 2.1 Infection hazard 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. -
Page 8: Accessories And Combination With Other Equipment
Instructions for use elements™ 8:1 2 Safety | 2.4 Accessories and combination with other equipment ▶ Check to make sure that the device is working properly and is in satisfac- tory condition before each use. ▶ Have parts with sites of breakage or surface changes checked by the Ser- vice. -
Page 9: Service And Repair
Instructions for use elements™ 8:1 2 Safety | 2.6 Service and repair 2.6 Service and repair Repairs, servicing and safety checks may only be performed by trained service personnel. The following persons are authorized to do this: ▪ Service technicians of KaVo branches after the appropriate product training ▪... -
Page 10: Description Of The Product
Instructions for use elements™ 8:1 3 Description of the product | 2.6 Service and repair 3 Description of the product elements™ 8:1, PN: 815-1655 The elements 8:1 electrical-driven handpiece is a dental handpiece according to 21 CFR § 872.4200 (dental handpieces and accessories) for the use by a trained professional in the field of general dentistry. -
Page 11: Intended Use
Instructions for use elements™ 8:1 3 Description of the product | 3.1 Intended use 3.1 Intended use Indications for use: The elements 8:1 handpiece is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. -
Page 12: Symbols On Product And Rating Plate
Instructions for use elements™ 8:1 3 Description of the product | 3.3 Symbols on product and rating plate 3.3 Symbols on product and rating plate The rating plates are affixed to the underside of the unit. Accompanying documents Caution Follow instructions for use Please note the instructions for use Please note the electronic instructions for use Certification... -
Page 13: Transportation And Storage Conditions
Instructions for use elements™ 8:1 3 Description of the product | 3.4 Transportation and storage conditions 3.4 Transportation and storage conditions ▶ Do not store in a refrigerated environment. Temperature: -20 °C to +70 °C (-4 °F to +158 °F) Relative humidity: 5% RH to 95% RH absence of condensation Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture (Keep dry) -
Page 14: Startup And Shut Down
Instructions for use elements™ 8:1 4 Startup and shut down 4 Startup and shut down WARNING Hazard from non-sterile products. Infection hazard for dentist and patient. ▶ Prior to initial startup and after each use, process the product and accessories. WARNING Dispose of the product in the appropriate manner. -
Page 15: Operation
Instructions for use elements™ 8:1 5 Operation | 5.1 Attaching the medical device 5 Operation 5.1 Attaching the medical device CAUTION Detachment of the medical device during treatment. Injury or property damage A medical device that is not properly locked in place can become disconnected from the motor coupling and fall off. - Page 16 Instructions for use elements™ 8:1 5 Operation | 5.3 Inserting the bur WARNING Use of unauthorized burs. Risk of injury. ▶ Comply with the instructions for use and the intended use of the bur. ▶ Only use burs that do not deviate from the specified data. WARNING Hazard from rotating bur.
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Page 17: Removing The Burs
Instructions for use elements™ 8:1 5 Operation | 5.4 Removing the burs 5.4 Removing the burs WARNING Hazard from rotating bur. Lacerations and damage to the chuck system. ▶ Do not touch rotating bur! ▶ Never push the push-button while the bur is rotating! ▶... -
Page 18: Checking For Malfunctions And Troubleshooting
Instructions for use elements™ 8:1 6 Checking for malfunctions and troubleshooting | 6.1 Check for malfunctions 6 Checking for malfunctions and troubleshooting 6.1 Check for malfunctions CAUTION Product heats up. Burn injury or product damage due to over-heating. ▶ Do not continue working if the product heats up irregularly. NOTICE Missing or damaged O-rings. - Page 19 Instructions for use elements™ 8:1 6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting ▶ Push the O-ring to the front, and remove it. ▶ Insert new O-rings into the grooves. 19 / 30...
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Page 20: Processing Steps In Accordance With Iso 17664
Instructions for use elements™ 8:1 7 Processing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use 7 Processing steps in accordance with ISO 17664 7.1 Preparations at the site of use WARNING Hazard from contaminated products. Contaminated products are associated with an infection risk. -
Page 21: Manual External Disinfection
Instructions for use elements™ 8:1 7 Processing steps in accordance with ISO 17664 | 7.2 Manual processing 7.2.3 Manual external disinfection WARNING Incomplete disinfection. Infection hazard. ▶ Only use disinfection procedures that are verified to be bactericidal, fungici- dal and virucidal. ▶... -
Page 22: Automated Processing
Instructions for use elements™ 8:1 7 Processing steps in accordance with ISO 17664 | 7.3 Automated processing 7.3 Automated processing WARNING Incomplete disinfection. Infection hazard. ▶ Only use disinfection procedures that are verified to be bactericidal, fungici- dal and virucidal. ▶... -
Page 23: Care Products And Systems - Servicing
Instructions for use elements™ 8:1 7 Processing steps in accordance with ISO 17664 | 7.4 Care products and systems - Servicing 7.4 Care products and systems - Servicing WARNING Sharp tool in the medical device. Injury hazard from sharp and/or pointed tool. ▶... -
Page 24: Packaging
Instructions for use elements™ 8:1 7 Processing steps in accordance with ISO 17664 | 7.5 Packaging Servicing the chuck KaVo recommends servicing the chuck system once a week using the chuck servicing program integrated in the device. Note Handpieces must be taken off the service couplings before the chuck service can be started and run. -
Page 25: Storage
Instructions for use elements™ 8:1 7 Processing steps in accordance with ISO 17664 | 7.7 Storage NOTICE Contact corrosion due to moisture. Damage to the product. ▶ Remove the product from the steam sterilization immediately after the sterilization cycle. The KaVo medical device has a maximum temperature resistance of up to 138 ℃... -
Page 26: Tools And Consumables
Instructions for use elements™ 8:1 8 Tools and consumables 8 Tools and consumables Available from dental suppliers. Availability may vary depending on region. Material summary Mat. No. INTRA instrument stand 3.005.5204 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 Spray head INTRA (KaVo Spray) 0.411.9911 INTRA service coupling... -
Page 27: Terms And Conditions Of Warranty
Instructions for use elements™ 8:1 9 Terms and conditions of warranty 9 Terms and conditions of warranty The following Terms and conditions of warranty apply to this KaVo medical de- vice: KaVo provides the end customer with a warranty of proper function and guar- antees zero defects in respect of material and processing for a period of 12 months from the date of the invoice, subject to the following conditions: In case of justified complaints, KaVo will honor its warranty with a free repair or...
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