Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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 ......................8 2.4 Accessories and combination with other equipment............
SMARTmatic is a registered trademark of KaVo Dental GmbH. All other trademarks are property of their respective owners. KaVo Original Factory Repair In the event of a repair, please ship your product to the KaVo Original Factory Repair using www.kavobox.com. KaVo Technical Service...
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Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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)
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Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 2 Safety | 2.3 Technical condition 2.3 Technical condition A damaged product or damaged or NOT KaVo original components could injure patients, users or third parties. 4 Only operate devices or components if they show no signs of damage on the outside.
Define the service interval depending on the frequency of use. 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 other people.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 3 Description of the product | 3.1 Intended use 3 Description of the product SURGmatic S11 L (Mat. no. 1.009.1010) SURGmatic S11 C (Mat. no. 1.009.1005) 3.1 Intended use...
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 3 Description of the product | 3.2 Technical Specifications 3.2 Technical Specifications Drive speed max. 40,000 rpm Speed transmission 1 : 1 Identification 1 blue ring Can be attached to...
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 4 Startup and shut down | 4.1 Checking the amount of water 4 Startup and shut down WARNING Hazard from contaminated products. Patients, users or third parties could be infected by contaminated medical devices.
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Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 4 Startup and shut down | 4.1 Checking the amount of water 4 Cool the dental bur via an external supply. 4 During surgical interventions, comply with the necessary precautions re- garding cooling.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 5 Operation | 5.1 Attaching the medical device 5 Operation 5.1 Attaching the medical device WARNING Detaching the medical device during treatment. A medical device that is not properly locked can detach from the coupling dur- ing treatment.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 5 Operation | 5.3 Inserting the dental bur 5.3 Inserting the dental bur NOTE Only use carbide burs or diamond burs that conform to DIN EN ISO 1797 type...
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 5 Operation | 5.4 Removing the dental bur CAUTION Incorrectly clamped dental bur. Material damage to the chuck system, dental bur is difficult or impossible to re- move from the chuck system.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 6 Checking for malfunctions and troubleshooting | 6.1 Check for malfunctions 6 Checking for malfunctions and troubleshooting 6.1 Check for malfunctions CAUTION Overheating of the device. Burns or product damage from overheating.
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Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting 4 Use the nozzle needle (Mat. no. 0.410.0931) to free the water passage at the spray tubes. 18 / 28...
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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...
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.3 Automated reprocessing 7.3 Automated reprocessing WARNING Sharp dental bur in the medical device. Injury hazard from sharp and/or pointed dental bur.
NOTE Please comply with the instructions for use of the washer disinfector. 4 In order not to affect the KaVo medical device, make sure that the product is dry on the inside and outside after completion of the cycle. 4 Immediately after drying, lubricate the KaVo medical device with care agents from the KaVo care system.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.5 Packaging 4 Position the tip of the spray nipple in the opening, and apply the spray.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.6 Sterilisation 7.6 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with EN 13060 / EN ISO 17665-1 CAUTION Improper service and care.
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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...
Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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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