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Summary of Contents for KaVo Dental EXPERTmatic E31 C
- Page 1 Instructions for use EXPERTmatic E31 C – 1.008.4998...
- Page 2 Distributed by: Manufacturer: KaVo Dental Technologies, LLC KaVo Dental GmbH Bismarckring 39 11727 Fruehauf Drive Charlotte, NC 28273 USA 88400 Biberach Phone: 847 550 6800 Germany Fax: 847 550 6825 www.kavo.com...
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Page 3: Table Of Contents
Instructions for use EXPERTmatic E31 C – 1.008.4998 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 E31 C – 1.008.4998 1 User instructions 1 User instructions Dear User, Congratulations on purchasing this KaVo quality product. By following the in- structions 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 E31 C – 1.008.4998 1 User instructions Serial number UDI symbol Manufacturer Attention: Please consult the accompanying documents Follow the electronic instructions for use HIBC Code CE mark for medical devices EAC conformity mark (Eurasian Conformity)
- Page 6 Instructions for use EXPERTmatic E31 C – 1.008.4998 1 User instructions CAUTION In cases which – if not prevented – can lead to minor or moderate injury. NOTICE In cases which – if not prevented – can lead to property damage.
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Page 7: Safety
Instructions for use EXPERTmatic E31 C – 1.008.4998 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 E31 C – 1.008.4998 2 Safety | 2.4 Accessories and combination with other equipment ▪ Irregular running noise ▪ Excessive vibration ▪ Overheating ▪ Bur is not seated firmly in the handpiece To ensure optimum function and to prevent property damage, please comply... - Page 9 Instructions for use EXPERTmatic E31 C – 1.008.4998 2 Safety | 2.6 Service and repair As a result of the use of NON-KaVo original spare parts during the repair, parts such as covers may become undone and injure the patient, user or third par- ties.
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Page 10: Product Description
Instructions for use EXPERTmatic E31 C – 1.008.4998 3 Product description | 3.1 Intended use 3 Product description EXPERTmatic Contra-angle handpiece E31 C (Mat. No. 1.008.4998) The electric driven EXPERTmatic handpieces are dental handpieces in accor- dance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for use by a trained professional in the field of general dentistry only. -
Page 11: Technical Specifications E31 C (Without Light)
Instructions for use EXPERTmatic E31 C – 1.008.4998 3 Product description | 3.2 Technical Specifications E31 C (without light) ▪ Comply with the specified intended use. ▪ Protect himself or herself, the patient and third parties from hazards. ▪ Prevent contamination by the product. -
Page 12: Startup And Shut-Down
Instructions for use EXPERTmatic E31 C – 1.008.4998 4 Startup and shut-down 4 Startup and shut-down WARNING Hazard from contaminated products. Patients, users or third parties can be infected by contaminated medical de- vices. 4 Prior to initial startup and after each use, process the product and acces- sories. -
Page 13: Operation
Instructions for use EXPERTmatic E31 C – 1.008.4998 5 Operation | 5.1 Attaching the medical device 5 Operation WARNING Swallowing or aspiration of loose parts or substances by the patient. Danger of suffocation. 4 Place a rubber dam before each treatment. -
Page 14: Removing The Bur
Instructions for use EXPERTmatic E31 C – 1.008.4998 5 Operation | 5.4 Removing the bur WARNING Use of non-approved burs. Injury to the patient or damage to the medical device. 4 Comply with the instructions for use and the intended use of the bur. - Page 15 Instructions for use EXPERTmatic E31 C – 1.008.4998 5 Operation | 5.4 Removing the bur 4 Unscrew it or take it off the insert after it has stopped rotating. NOTE Follow the manufacturer's instructions for use when reusing the inserts.
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Page 16: Checking For Malfunctions And Troubleshooting
Instructions for use EXPERTmatic E31 C – 1.008.4998 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. Burn injury or product damage due to over-heating. - Page 17 Instructions for use EXPERTmatic E31 C – 1.008.4998 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: Processing Steps In Accordance With Iso 17664-1 / Iso 17664-2
Instructions for use EXPERTmatic E31 C – 1.008.4998 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.1 Preparations at the site of use 7 Processing 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 External Disinfection
Instructions for use EXPERTmatic E31 C – 1.008.4998 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.3 Automated preprocessing 7.2.3 Manual external disinfection WARNING Incomplete disinfection. Patients, users or third parties may get infected by contaminated medical de- vices. -
Page 20: Automated Internal And External Cleaning And Internal And External Disinfection
Instructions for use EXPERTmatic E31 C – 1.008.4998 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.4 Care products and systems - Servicing NOTICE Never process this medical device in an ultrasonic device. Malfunction and material damage. -
Page 21: Servicing With Kavo Quattrocare Plus
Instructions for use EXPERTmatic E31 C – 1.008.4998 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.5 Packaging 4 Remove the bur from the medical device. 4 Cover the medical device with the KaVo Cleanpac bag, and place it on the corresponding care adapter. -
Page 22: Storage
Instructions for use EXPERTmatic E31 C – 1.008.4998 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.7 Storage ▪ Sterilizer with gravity displacement method: – 10 minutes at 135 °C (275 °F) Drying time: 30 min. – 15 minutes at 132 ... -
Page 23: Optional Aids And Consumables
Instructions for use EXPERTmatic E31 C – 1.008.4998 8 Optional aids and consumables 8 Optional aids and consumables Available from dental suppliers. Material summary Mat. no. Holder 1.004.0596 INTRA Instrument stand 3.005.5204 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862... -
Page 24: Terms And Conditions Of Warranty
Instructions for use EXPERTmatic E31 C – 1.008.4998 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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