KaVo SURGmatic S11 L Instructions For Use Manual
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KaVo SURGmatic S11 L Instructions For Use Manual

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Instructions for use
SURGmatic S11 L – 1.009.1010
SURGmatic S11 C – 1.009.1005

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Summary of Contents for KaVo SURGmatic S11 L

  • Page 1 Instructions for use SURGmatic S11 L – 1.009.1010 SURGmatic S11 C – 1.009.1005...
  • Page 2 Manufacturer: Distributed by: KaVo Dental Technologies, LLC KaVo Dental GmbH 11727 Fruehauf Drive Bismarckring 39 Charlotte, NC 28273 USA 88400 Biberach Germany Phone: 847 550 6800 Fax: 847 550 6825 www.kavo.com...

  • Page 3: Table Of Contents

    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............

  • Page 4: User Instructions

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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.
  • Page 5 Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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...
  • Page 6 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. NOTICE In cases which – if not prevented – can lead to property damage.

  • Page 7: Safety

    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.

  • Page 8: Technical Condition

    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 Use the device and components only if there is no damage on the outside.

  • Page 9: Service And Repair

    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 peo- ple.

  • Page 10: Product Description

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 3 Product description | 3.1 Intended use 3 Product description SURGmatic S11 L (Mat. No. 1.009.1010) SURGmatic S11 C (Mat. No. 1.009.1005) The electric driven SURGmatic handpieces are dental handpieces in accordance with 21 CFR §...
  • Page 11 Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 3 Product description | 3.1 Intended use Proper Use: According to these regulations, this product may only be used for the described application by a properly trained user. You need to comply with the following: ▪...

  • Page 12: Technical Specifications

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 3 Product description | 3.2 Technical Specifications 3.2 Technical Specifications Drive speed max. 40,000 rpm Speed transmission 1 : 1 Labeling 1 blue ring Can be attached to...

  • Page 13: Startup And Shut-Down

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 4 Startup and shut-down | 4.1 Checking the water quantity 4 Startup and shut-down WARNING Hazard from contaminated products. Patients, users or third parties can be infected by contaminated medical de- vices.
  • Page 14 Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 4 Startup and shut-down | 4.1 Checking the water quantity 4 Cool the bur via an external supply. 4 During surgical interventions, comply with the necessary precautions re- garding cooling.

  • Page 15: Operation

    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 Detachment of the medical device during treatment. A medical device that is not properly locked can detach from the coupling dur- ing treatment.

  • Page 16: Inserting The Bur

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 5 Operation | 5.3 Inserting the bur 5.3 Inserting the bur NOTE Only use carbide burs or diamond burs that conform to ISO 1797 type 1 and type 2, are made of steel or hard metal, and meet the following criteria: - Shaft diameter: 2.334 to 2.350 mm...

  • Page 17: Remove The Bur

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 5 Operation | 5.4 Remove the bur NOTICE Bur shaft slips inside the chuck due to excessive speed of the bur or abrupt engagement of the bur.

  • Page 18: Checking For Malfunctions And Troubleshooting

    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. Burn injury or product damage due to over-heating.
  • Page 19 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. 19 / 28...

  • Page 20: Processing Steps In Accordance With Iso 17664-1 / Iso 17664-2

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 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...

  • Page 21: Automated Processing

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.3 Automated processing 7.3 Automated processing WARNING Sharp bur in the medical device. Injury hazard from sharp and/or pointed bur.

  • Page 22: Care Products And Systems - Servicing

    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. 4 Press the spray key once for 1-2 seconds.

  • Page 23: Servicing With Kavo Quattrocare Plus

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.5 Packaging Servicing the chuck KaVo recommends servicing the chuck system once weekly. 4 Remove the bur from the medical device.

  • Page 24: Sterilization

    Instructions for use SURGmatic S11 L – 1.009.1010, SURGmatic S11 C – 1.009.1005 7 Processing steps in accordance with ISO 17664-1 / ISO 17664-2 | 7.6 Sterilization 7.6 Sterilization Sterilization in a steam sterilizer (autoclave) in accordance with ISO 17665-1 Sterilization has to be performed using a steam sterilizer (autoclave) approved by the U.S.

  • Page 25: Optional Aids And Consumables

    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 dental suppliers. Material summary Mat. no. INTRA Instrument stand 3.005.5204 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862...

  • Page 26: Terms And Conditions Of Warranty

    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 provides the end customer with a warranty of proper function and guar-...

This manual is also suitable for:

Surgmatic s11 c1.009.10101.009.1005

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