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Summary of Contents for KaVo Dental EXPERTmatic E61 C
- Page 1 Instructions for use EXPERTmatic E61 C – 1.008.4999...
- 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...
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Page 3: Table Of Contents
Instructions for use EXPERTmatic E61 C – 1.008.4999 Table of contents Table of contents 1 User instructions....................... 2 Safety ..........................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
Instructions for use EXPERTmatic E61 C – 1.008.4999 1 User instructions 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 EXPERTmatic is a registered trademark of KaVo Dental GmbH. - Page 5 Instructions for use EXPERTmatic E61 C – 1.008.4999 1 User instructions Serial number UDI symbol Manufacturer Note: Please note accompanying documents Follow the electronic instructions for use HIBC Code CE mark for medical devices EAC conformity mark (Eurasian Conformity) Medical device, labelling of medical devices...
- Page 6 Instructions for use EXPERTmatic E61 C – 1.008.4999 1 User instructions CAUTION In cases which – if not prevented – can lead to minor or moderate injury. CAUTION In cases which – if not prevented – can lead to material damage.
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Page 7: Safety
Instructions for use EXPERTmatic E61 C – 1.008.4999 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 EXPERTmatic E61 C – 1.008.4999 2 Safety | 2.4 Accessories and combination with other equipment ▪ Malfunctions ▪ Damage (e.g., from dropping) ▪ Irregular running noise ▪ Excessive vibration ▪ Overheating ▪ Dental bur is not seated firmly in the handpiece... - Page 9 Instructions for use EXPERTmatic E61 C – 1.008.4999 2 Safety | 2.6 Service and repair 4 Have the service and testing tasks carried out according to the Medical Device Operator Ordinance. 4 KaVo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a func- tion check.
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Page 10: Description Of The Product
Instructions for use EXPERTmatic E61 C – 1.008.4999 3 Description of the product | 3.1 Intended use 3 Description of the product EXPERTmatic Contra-angle handpiece E61 C (Mat. no. 1.008.4999) 3.1 Intended use Indications for use: This medical device is: ▪... -
Page 11: Transportation And Storage Conditions
Instructions for use EXPERTmatic E61 C – 1.008.4999 3 Description of the product | 3.3 Transportation and storage conditions Spray water pressure 0.8 to 2.0 bar (12 to 29 psi) Spray air pressure 1.0 to 2.0 bar (15 to 29 psi) Spray air flow rate min. -
Page 12: Startup And Shut Down
Instructions for use EXPERTmatic E61 C – 1.008.4999 4 Startup and shut down 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 ac- cessories. -
Page 13: Operation
Instructions for use EXPERTmatic E61 C – 1.008.4999 5 Operation | 5.1 Attaching the medical device 5 Operation WARNING The patient swallows or aspirates loose parts or substances. Danger of suffocation. 4 Place a rubber dam before each treatment. WARNING Axially moved files. -
Page 14: Inserting The Dental Bur
Instructions for use EXPERTmatic E61 C – 1.008.4999 5 Operation | 5.3 Inserting the dental bur 5.3 Inserting the dental bur NOTE Files from the firm Intensiv can be used. WARNING Use of unauthorised dental burs. Injury to the patient or damage to the medical device. -
Page 15: Use
Instructions for use EXPERTmatic E61 C – 1.008.4999 5 Operation | 5.5 Use 4 When the file has stopped moving, push file forward with ejector and re- move it from the head. 5.5 Use CAUTION Overheating of the tooth due to insufficient amount of cooling water. -
Page 16: Checking For Malfunctions And Troubleshooting
Instructions for use EXPERTmatic E61 C – 1.008.4999 6 Checking for malfunctions and troubleshooting | 6.1 Checking for malfunctions 6 Checking for malfunctions and troubleshooting 6.1 Checking for malfunctions CAUTION Overheating of the device. Burns or product damage from overheating. - Page 17 Instructions for use EXPERTmatic E61 C – 1.008.4999 6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting 4 Spray a lint-free cloth with KaVo Spray, apply it to the new O-rings and in- sert them in the recesses. 17 / 28...
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Page 18: Reprocessing Steps In Accordance With Iso 17664-1 / Iso 17664-2
Instructions for use EXPERTmatic E61 C – 1.008.4999 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.1 Preparations at the site of use 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. -
Page 19: Manual Reprocessing
Instructions for use EXPERTmatic E61 C – 1.008.4999 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.2 Manual Reprocessing 7.2 Manual Reprocessing WARNING Incomplete disinfection. Patients, users or third parties could be infected by contaminated medical devices. -
Page 20: Manual Drying
Instructions for use EXPERTmatic E61 C – 1.008.4999 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.3 Automated reprocessing 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 21: Pre-Cleaning
Instructions for use EXPERTmatic E61 C – 1.008.4999 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.4 Care products and systems - Servicing CAUTION Never reprocess this medical device in an ultrasonic cleaner. Malfunction and material damage. -
Page 22: Servicing With Kavo Spray
Instructions for use EXPERTmatic E61 C – 1.008.4999 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.5 Packaging NOTE Remove the servicing dental bur. 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. -
Page 23: Storage
Instructions for use EXPERTmatic E61 C – 1.008.4999 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.7 Storage 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 the available steriliser): ▪... -
Page 24: Optional Aids And Consumables
Instructions for use EXPERTmatic E61 C – 1.008.4999 8 Optional aids and consumables 8 Optional aids and consumables Available from specialised dental dealers. Material summary Mat. no. INTRA Instrument stand 3.005.5204 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 Set of files 1.003.5452... -
Page 25: Terms And Conditions Of Warranty
Instructions for use EXPERTmatic E61 C – 1.008.4999 9 Terms and conditions of warranty 9 Terms and conditions of warranty This KaVo medical device is subject to the following warranty conditions: KaVo grants the end customer a warranty of proper function and guarantees...
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