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KaVo SURGmatic S11 C, Instructions For Use Manual, Page: 17 / 68

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KaVo SURGmatic S11 C Instructions For Use Manual Download Page 17

3.1   Purpose – Proper use

Purpose:

This medical device is

▪ Only intended for dental treatment. Any other type of use or altera‐

tion to the product is impermissible and can be hazardous. The med‐

ical device is intended for the following uses: Surgery such as setting

an implant, bone augmentation, sinus lift, tooth extraction, implantol‐

ogy and oral, jaw and facial surgery.

▪ A medical device according to relevant national statutory regulations.

 

 

 

Product description

15

Summary of Contents for SURGmatic S11 C

Page 1: ...Instructions for use SURGmatic S11 L 1 009 1010 SURGmatic S11 C 1 009 1005...

Page 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Phone 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com...

Page 3: ...s 7 2 2 Safety instructions 9 3 Product description 14 3 1 Purpose Proper use 15 3 2 Technical Specification 17 3 3 Transportation and storage conditions 18 4 Start up and shut down 20 4 1 Checking th...

Page 4: ...Troubleshooting 33 6 1 Check for malfunctions 33 6 2 Troubleshooting 34 6 2 1 Troubleshooting Cleaning the spray tube 34 7 Reprocessing steps in accordance with ISO 17664 36 7 1 Preparation at the si...

Page 5: ...systems Servicing Care with KaVo Spray 47 7 6 2 Care products and systems Servicing Care with KaVo SPRAYrotor 49 7 6 3 Care products and systems Servicing Servicing with KaVo QUATTROcare 2104 2104A 50...

Page 6: ...7 9 Storage 59 8 Tools 61 9 Terms and conditions of warranty 63 Table of contents 4...

Page 7: ...quality product By following the instructions below you will be able to work smoothly economically and safely Copyright by KaVo Dental GmbH Symbols Refer to the chapter on Safety Warning symbol Import...

Page 8: ...mark European Community A product bearing this mark meets the requirements of the applicable EC directive Action request Target group This document is intended for dentists and their assistants The se...

Page 9: ...ctions Warning symbol Structure DANGER The introduction describes the type and source of the hazard This section describes potential consequences of non compliance The optional step includes necessary...

Page 10: ...the three levels of danger will help avert property damage and injury CAUTION CAUTION indicates a hazardous situation that can cause damage to property or mild to moderate injuries WARNING WARNING ind...

Page 11: ...use death or fatal injury 2 2 Safety instructions WARNING Hazards for the care provider and the patient In the case of damage irregular running noise excessive vibration un typical warming or when the...

Page 12: ...dental treatment unit connected must have control equipment for changing the speed and direction of rotation A note is to be included in the documents accompanying the dental treatment unit referring...

Page 13: ...stored instrument Injury and infection caused by chucked cutters or grinders Damage to clamping system from dropping the instrument After treatment place the instrument properly in the cradle without...

Page 14: ...onuse Reduced product life The medical device should be cleaned serviced and stored in a dry location according to instructions before long periods of non use Note For safety reasons we recommend that...

Page 15: ...described in the KaVo Instructions for Use and the care products and care systems described therein must be used KaVo recommends specifying a service interval at the dental office for a licensed shop...

Page 16: ...3 Product description S11 L SURGmatic SURGmatic S11 L Mat no 1 009 1010 S 11 C SURGmatic SURGmatic S11 C Mat no 1 009 1005 Product description 14...

Page 17: ...o the product is impermissible and can be hazardous The med ical device is intended for the following uses Surgery such as setting an implant bone augmentation sinus lift tooth extraction implantol og...

Page 18: ...and safety regulations the applicable accident prevention regulations these instructions for use According to these regulations it is the responsibility of the user to only use equipment that is oper...

Page 19: ...ion 1 1 Maximum speed max 40 000 rpm Handpiece cutters or grinders can be used Short handpiece cutters or grinders can be used after conversion The handpiece can be mounted on all INTRAmatic LUX motor...

Page 20: ...t has been stored strongly refrigerated This can cause the medical device to malfunction Prior to start up very cold products must be heated to a tempera ture of 20 C to 25 C 68 F to 77 F Temperature...

Page 21: ...Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 19...

Page 22: ...e provider and patient Before first use and after each use prepare and sterilise the medi cal device if needed WARNING Disposal of the product in the appropriate manner Prior to disposal the product m...

Page 23: ...he amount of water CAUTION Overheating of the tooth due to lack of cooling water Thermal damage to the dental pulp Adjust the water amount for the spray cooling to a minimum of 50 cm3 min Start up and...

Page 24: ...oth Check spray water channels and if necessary clean spray nozzles with the nozzle needle Mat no 0 410 0931 Switch off spray air and spray water supply on the treatment device Cooling the drill bit o...

Page 25: ...Use physiological sterile cooling fluid Start up and shut down 23...

Page 26: ...device during treatment A medical device that is not properly locked in place can become dis connected from the motor coupling and fall off Carefully pull on the medical device before each treatment...

Page 27: ...handpiece when the chuck is closed CAUTION Removing and attaching the handpiece while the drive motor is rotating Damage to the catch Never attach or remove the handpiece while the device is rotating...

Page 28: ...tic S11 L the latch must lock into place audibly Pull on the medical device to make sure that it is securely affixed to the coupling 5 2 Remove the medical device Unlock the medical device from the mo...

Page 29: ...1 type 1 and type 2 are made of steel or hard metal and meet the following criteria Shaft diameter 2 334 to 2 35 mm In contra angle drills with drill bur stop Shaft clamping length at least 12 mm Over...

Page 30: ...nstructions for use and use the cutter or grinder prop erly Only use cutters or grinders that do not deviate from the specified data CAUTION Injury from using worn drill bits or burs Drill bits or bur...

Page 31: ...om defective chucking system The cutter or grinder could fall out and cause injury Pull on the cutter or grinder to check that the chucking system is okay and the cutter or grinder is securely held Wh...

Page 32: ...the cutter or grinder is securely attached by pulling on it 5 4 Remove the handpiece or contra angle drill bit WARNING Hazard from rotating cutter or grinder Lacerations and damage to the chucking sys...

Page 33: ...clamping ring back into its initial position 5 5 Conversion for contra angle handpiece drill bit Note The handpiece must be converted to use contra angle handpiece drill bits Open the handpiece chuck...

Page 34: ...To remove the drill bit stop use the accompanying hook Operation 32...

Page 35: ...g of the product Burns or product damage from overheating Do not use the product if it is irregularly heated The medical device is too hot while working Service the medical device When the speed drops...

Page 36: ...Troubleshooting Cleaning the spray tube CAUTION Hazard from insufficient amount of spray water Insufficient spray water can cause the medical device to overheat and damage the tooth Check spray water...

Page 37: ...Use the nozzle needle Mat no 0 410 0931 to free the water pas sage at the spray tubes Troubleshooting 35...

Page 38: ...ical devices Take suitable personal protective measures Remove the cutter or grinder from the medical device Remove all residual cement composite or blood immediately Recondition the medical device as...

Page 39: ...3 6 F Nozzle pin Brush e g medium hard toothbrush Disposable syringe Check the patency of spray tube and clean it using the nozzle pin Mat no 0 410 0931 Rinse through the spray tube with at least 20 m...

Page 40: ...er water for at least 20 sec onds using a medium hard toothbrush The non fixing preliminary cleaning is a central constituent and must be carried out prior to the automatic reconditioning In the KaVo...

Page 41: ...In the cleaning and disinfecting device validated internal cleaning of the spray tube necessitates preliminary non fixing cleaning Reprocessing steps in accordance with ISO 17664 39...

Page 42: ...rom cleaning in the ultrasonic unit Defects in the product The instrument must not be cleaned in ultrasonic devices 7 3 1 Cleaning Manual external and internal cleaning Not applicable Reprocessing ste...

Page 43: ...rried out with Programme VARIO TD cleaning agent neodisher mediclean neutralisation agent neodisher Z and rinsing agent neodisher miel clear and only applies to the material compatibility with KaVo pr...

Page 44: ...th servicing agents from the KaVo care system Manual external and internal cleaning cannot be performed Follow ing the non fixing preliminary cleaning item 7 2 the reprocessing must be continued in th...

Page 45: ...ng a disinfectant bath or disinfectant containing chlorine Defects in the device Only disinfect in the thermodisinfector 7 4 1 Disinfection Manual external and internal disinfection Not applicable Rep...

Page 46: ...ion was carried out with Programme VARIO TD cleaning agent neodisher mediclean neutralisation agent neodisher Z and rinsing agent neodisher miel clear and only applies to the material compatibility wi...

Page 47: ...cycle and then grease it immediately with servicing agents from the KaVo care system 7 5 Drying Manual Drying Blow off the outside and inside with compressed air until water drops are no longer visib...

Page 48: ...Sharp cutters or grinders in the medical device Risk of injury from sharp or pointed cutters or grinders Remove cutter or grinder CAUTION Premature wear and malfunctions from improper servicing and c...

Page 49: ...d for proper use on our products 7 6 1 Care products and systems Servicing Care with KaVo Spray KaVo recommends servicing the product after each time it is used i e af ter each automatic cleaning and...

Page 50: ...button for one second Servicing of the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week Remove the cutter or grinder place the spray nipple tip in the open ing and sp...

Page 51: ...tor KaVo recommends servicing the product after each time it is used i e af ter each automatic cleaning and before each sterilisation Place the product on the appropriate coupling of the KaVo SPRAYrot...

Page 52: ...h expansion pressure for the cleaning of inorganic residues and optimum care KaVo recommends servicing the product after each disinfection and be fore each sterilisation in the scope of the reprocessi...

Page 53: ...s servicing the product after each disinfection and be fore each sterilisation in the scope of the reprocessing Remove the cutter or grinder Servicing the product in QUATTROcare PLUS See also Instruct...

Page 54: ...2124 A Note Handpieces must be taken off the service couplings before the chuck service can be started and performed Remove the service coupling chuck from the side hatch of the QUATTROcare PLUS and a...

Page 55: ...andpiece together with the guide bush of the chuck to be serviced against the tip of the service coupling chuck Press the button showing the chuck service symbol Reprocessing steps in accordance with...

Page 56: ...minutes with no service procedure running the de vice automatically switches back to normal service mode See also Care with KaVo QUATTROcare PLUS 7 6 5 Care products and systems Servicing Servicing wi...

Page 57: ...nder Service the product in QUATTROcare PLUS See also Instructions for use KaVo QUATTROcare CLEAN 2140 A Servicing the clamping chuck KaVo recommends cleaning and servicing the chuck system once a wee...

Page 58: ...that the bag is not stretched The quality and use of the sterilisation packaging must satisfy applicable standards and be suitable for the sterilisation procedure Individually seal the medical device...

Page 59: ...accordance with EN 13060 ISO 17665 1 CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Before each sterilisation cycle service the medical device with Ka V...

Page 60: ...ure Damage to product Immediately remove the product from the steam steriliser after the sterilisation cycle The KaVo medical device has a maximum temperature resistance up to 138 280 4 F Reprocessing...

Page 61: ...inutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Autoclave using the gravity method at least 10 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Use according to the manufacturer s Instructions for Use 7 9 Storage...

Page 62: ...Comply with the expiry date of the sterilised items Reprocessing steps in accordance with ISO 17664 60...

Page 63: ...9501 Cleanpac 10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 Drill stop 0 524 0892 Hook 0 410 1963 Nozzle needle 0 410 0931 Coupling piece 0 593 0361 Spray head INTRA KaVo Spray 0 411 9911 Ser...

Page 64: ...aptor INTRAmatic CLEANspray and DRYspray 1 007 1776 KaVo CLEANspray 2110 P 1 007 0579 KaVo DRYspray 2117 P 1 007 0580 KaVo Spray 2112 A 0 411 9640 ROTAspray 2 2142 A 0 411 7520 QUATTROcare plus Spray...

Page 65: ...anty with a free replacement or repair Other claims of any nature whatsoever in particu lar with respect to compensation are excluded In the event of default gross negligence or intent this shall only...

Page 66: ...urfastness of plastic parts All liability is excluded if defects or their consequences originate from ma nipulations or changes to the product made by the customer or a third party that is not authori...

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