KaVo SMARTmatic S80 K Instructions For Use Manual

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Instructions for use

SMARTmatic S80 K - 1.011.6771

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Summary of Contents for KaVo SMARTmatic S80 K

Page 1 Instructions for use SMARTmatic S80 K - 1.011.6771...
Page 2 Distributed by: Manufacturer: KaVo Dental Corporation Kaltenbach & Voigt GmbH 11729 Fruehauf Drive Bismarckring 39 Charlotte, NC 28273 USA D-88400 Biberach Phone: 847 550 6800 www.kavo.com Fax: 847 550 6825...
Page 3 Instructions for use SMARTmatic S80 K - 1.011.6771 Table of contents Table of contents 1 User instructions............................. 4 2 Safety ................................6 2.1 Infection hazard ............................. 2.2 Technical condition ..........................2.3 Accessories and combination with other equipment................2.4 Qualification of personnel ........................
Page 4 Instructions for use SMARTmatic S80 K - 1.011.6771 1 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 KaVo Repair Service...
Page 5 Instructions for use SMARTmatic S80 K - 1.011.6771 1 User instructions CE mark according to Medical Devices Directive EC 93/42 Consult instructions for use Caution: Consult instructions for use EAC conformity mark (Eurasian Conformity) GOST R certification Transportation and storage conditions...
Page 6 Instructions for use SMARTmatic S80 K - 1.011.6771 2 Safety | 2.1 Infection hazard 2 Safety The instructions for use are a component of the product and must be read carefully prior to use and be accessible at all times.
Page 7 The following persons are authorized to do this: ▪ Service technicians of KaVo branches after the appropriate product training ▪ Service technicians of KaVo authorized dealers after the appropriate product train- Comply with the following items during all servicing work: ▶...
Page 8 Instructions for use SMARTmatic S80 K - 1.011.6771 3 Description of the product | 3.1 Intended use 3 Description of the product SMARTmatic S80 K (Mat. No. 1.011.6771) The SMARTmatic electrical-driven handpieces are dental handpieces according to 21 CFR § 872.4200 (dental handpieces and accessories) for the use by a trained profes- sional in the field of general dentistry.
Page 9 Instructions for use SMARTmatic S80 K - 1.011.6771 3 Description of the product | 3.2 Technical Specifications In accordance with these regulations, the user is required to: ▪ only use equipment that is operating properly ▪ adhere to the specified intended use ▪...
Page 10 Instructions for use SMARTmatic S80 K - 1.011.6771 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.
Page 11 Property damage to the medical device. ▶ Do not connect or remove the medical device while pressing the foot switch. ▶ Lightly spray O-rings on motor coupling with KaVo Spray. ▶ Attach the medical device to the motor coupling and lock it into place.
Page 12 Instructions for use SMARTmatic S80 K - 1.011.6771 5 Operation | 5.4 Removing the burs WARNING Hazard from rotating bur. Lacerations. ▶ Do not touch the bur while it is rotating! ▶ Remove the bur from the medical device after treatment to avoid injury and infec- tion when putting it away.
Page 13 Instructions for use SMARTmatic S80 K - 1.011.6771 6 Checking for malfunctions and troubleshooting | 6.1 Check for malfunctions 6 Checking for malfunctions and troubleshooting 6.1 Check for malfunctions CAUTION Missing or damaged O-rings. Malfunctions and premature failure. ▶ Make sure that all O-rings are present on the coupling and are undamaged.
Page 14 ▶ Brush under flowing tap water. 7.2.2 Automated external cleaning KaVo recommends washer disinfectors in compliance with ISO 15883-1, which are operated using alkaline cleaning agents. ▶ The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector.
Page 15 Please comply with the instructions for use of the washer disinfector. 7.3 Disinfection WARNING Incomplete disinfection. Infection hazard. ▶ Principally, KaVo recommends carrying out an final disinfection of the unpack- aged item to guarantee the complete disinfection. NOTICE Using the disinfectant bath or chlorine-containing disinfectants. Functional damage and property damage.
Page 16 7.5.1 Servicing with KaVo Spray KaVo recommends servicing the product as part of the processing after each use, i.e. after each cleaning, disinfection, and before each sterilization. 16 / 24...
Page 17 (no validated internal cleaning in accordance with German RKI requirements) KaVo recommends servicing the product as part of the processing after each use, i.e. after each cleaning, disinfection, and before each sterilization. ▶ Remove the bur.
Page 18 (no validated internal cleaning in accordance with German RKI requirements) KaVo recommends servicing the product as part of the processing after each use, i.e. after each cleaning, disinfection, and before each sterilization. ▶ Remove the bur.
Page 19 Sterilization in a steam sterilizer (autoclave) in accordance with ISO 17665-1 NOTICE Improper service and care. Premature wear and reduced product service life. ▶ Before each sterilization cycle, service the medical device with KaVo care prod- ucts. NOTICE Contact corrosion due to moisture. Damage to the product.
Page 20 Instructions for use SMARTmatic S80 K - 1.011.6771 8 Tools and consumables 8 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 Spray head INTRA (KaVo Spray) 0.411.9911...
Page 21 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 re- placement, as needed. Other claims of any nature whatsoever, in particular with re- spect to compensation, are excluded.

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