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▪ A medical device according to relevant national statutory regulations.

Proper use:

According to these regulations, this medical device may only be used for

the described application by a knowledgeable user. You need to comply

with the following:

▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use

According to these regulations, the user is required to:

▪ only use equipment that is operating correctly,
▪ adhere to the specified intended use

3 Product description

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Содержание INTRAflex LUX 2 program 2307 LN 0.535.6190

Страница 1: ...Instructions for use INTRAflex LUX 2 program 2307 LN 0 535 6190 2320 LN 0 535 6180 2329 LN 0 535 6200 2313 LN 0 535 6220 2325 LN 0 535 6210...

Страница 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...

Страница 3: ...t description 18 3 1 Purpose Intended use 20 3 2 Technical Specifications 22 3 2 1 Reducing shank 2307 LN 22 3 2 2 Reducing shank 2320 LN 23 3 2 3 Reducing shank 2329 LN 24 3 2 4 Handpiece 2313 LN 25...

Страница 4: ...ases 2307 LN 2320 LN or 2329 LN 40 5 5 Insert handpiece or contra angle drill in handpiece 2313 LN 41 5 6 Remove handpiece or contra angle drill from handpiece 2313 LN 45 5 7 Modification of the handp...

Страница 5: ...Automated internal cleaning 58 7 3 Disinfection 59 7 3 1 Manual external disinfection 60 7 3 2 Manual internal disinfection 61 7 3 3 Automated external and internal disinfection 62 7 4 Care products...

Страница 6: ...7 4 5 Servicing with KaVo QUATTROcare 2140 A 75 7 5 Packaging 77 7 6 Sterilisation 78 7 7 Storage 80 8 Tools and consumables 81 9 Terms and conditions of warranty 84 Contents 6 88...

Страница 7: ...ality 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 Importan...

Страница 8: ...requirements of the applicable EC directive Can be steam sterilizes at 134 o C 1 o C 4 o C 273 o F 1 6 o F 7 4 o F Target group This document is intended for dentists and their assistants The section...

Страница 9: ...ons Warning symbol Structure DANGER The introduction describes the type and source of the haz ard This section describes potential consequences of non compliance The optional step includes necessary m...

Страница 10: ...ty instructions listed here together with 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 mil...

Страница 11: ...NG WARNING indicates a hazardous situation that can lead to serious or fatal injury DANGER DANGER indicates a maximal hazard due to a situation that can directly cause death or fatal injury 2 Safety 1...

Страница 12: ...G Hazards for the care provider and the patient In the case of damage irregular running noise excessive vibration un typical warming or when the cutter or grinder cannot be held Do not use further and...

Страница 13: ...contaminated products Take suitable personal protective measures CAUTION Risk of burn injury from hot handpiece head or hot hand piece lid Burn injuries in the mouth may be caused if the handpiece ove...

Страница 14: ...a light probe Do not use the device as a light probe since the rotating cutters or grind ers can cause injury Use an appropriate light probe for additional illumination of the oral cavity or site of...

Страница 15: ...ored 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 th...

Страница 16: ...use Reduced product life The medical device should be cleaned serviced and stored in a dry lo cation according to instructions before long periods of nonuse Note For safety reasons we recommend that t...

Страница 17: ...cribed 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 to...

Страница 18: ...3 Product description INTRAflex LUX base 2307 LN Mat no 0 535 6190 INTRAflex LUX base 2320 LN Mat no 0 535 6180 3 Product description 18 88...

Страница 19: ...INTRAflex LUX base 2329 LN Mat no 0 535 6200 INTRAflex LUX handpiece 2313 LN Mat no 0 535 6220 3 Product description 19 88...

Страница 20: ...r dental treatment only All other types of use or modifica tions of the product are not permitted and can be hazardous The medical device is intended for the following applications Removal of carious...

Страница 21: ...bed application by a knowledgeable user You need to comply with the following the applicable health and safety regulations the applicable accident prevention regulations these Instructions for use Acc...

Страница 22: ...cations 3 2 1 Reducing shank 2307 LN Identification 1 green ring Transmission ratio 2 7 1 Induction air 2 5 to 3 0 bar 29 to 44 psi Air consumption 50 to 60 Nl min Speed range 5 000 to 12 000 min 1 Id...

Страница 23: ...entification 1 blue ring Transmission ratio 1 1 Induction air 2 5 to 3 0 bar 29 to 44 psi Air consumption 50 to 60 Nl min Speed range 15 000 to 35 000 min 1 Idle torque at 3 0 bar 44 psi 1 6 Ncm The v...

Страница 24: ...io 7 4 1 Induction air 2 5 to 3 0 bar 29 to 44 psi Air consumption 50 to 60 Nl min Speed range 2 000 to 5 000 min 1 Idle torque at 3 0 bar 44 psi 5 5 Ncm The values apply for the application of the IN...

Страница 25: ...on air 2 5 to 3 0 bar 29 to 44 psi Air consumption 50 to 60 Nl min Speed range 5 000 to 12 000 min 1 Idle torque at 3 0 bar 44 psi 3 2 Ncm Handpiece drills can be used Contra angles drills can be used...

Страница 26: ...to 3 0 bar 29 to 44 psi Air consumption 50 to 60 Nl min Speed range 60 000 to 140 000 min 1 Idle torque at 3 0 bar 44 psi 0 32 Ncm Handpiece cutters or grinders can be used Attachable to all MULTIfle...

Страница 27: ...y refrigerated This can cause the medical device to malfunction Prior to start up very cold products must be heated to a temperature of 20o C to 25o C 68o F to 77o F Temperature 20 C to 70 C 4 F to 15...

Страница 28: ...Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture 3 Product description 28 88...

Страница 29: ...nt Before first use and after each use prepare and sterilise the medical device and accessories accordingly WARNING Disposal of the product in the appropriate manner Prior to disposal the product and...

Страница 30: ...se malfunctions Make sure that the supply of cooling air is dry clean and uncontami nated according to EN ISO 7494 2 4 1 Mount the MULTIflex LUX MULTIflex LED coupling Screw the MULTIflex LUX MULTIfle...

Страница 31: ...rder to regulate the fraction of water 4 2 Checking the 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...

Страница 32: ...3 4 Start up and shut down 32 88...

Страница 33: ...r leads to premature wear and tear Ensure that the cooling air is dry clean and uncontaminated in accord ance with EN ISO 7494 2 A minimum drive pressure of 2 5 bar 29 psi is required to operate the m...

Страница 34: ...MULTIflex LUX MULTIflex LED coupling and check the following pressures Drive air 2 5 to 3 0 bar 29 to 44 psi recommended 3 0 44 bar psi Return air 1 bar 15 psi Water 1 0 to 2 0 bar 15 to 29 psi Spray...

Страница 35: ...king the O rings CAUTION Missing or damaged O rings Malfunctions and premature failure Make sure that all O rings are on the coupling and undamaged Number of available O rings 5 4 Start up and shut do...

Страница 36: ...ing treatment A medical device that is not properly locked in place can release from the MULTIflex LUX MULTIflex LED coupling during treatment Before each use check if the medical device is securely l...

Страница 37: ...the LED of a MULTIflex LUX MULTIflex LED coupling or reduce its service life Pull on the medical device to make sure that it is securely affixed to the coupling Mount the medical device accurately on...

Страница 38: ...the medical device to make sure that it is securely affixed to the coupling 5 2 Removing the medical device Hold the coupling tight and pull the medical device off while twisting slight ly 5 Operatio...

Страница 39: ...atment If the head is not properly locked in place it can fall out during treatment Do not mount or remove the head while rotating Before each treat ment check that the head is firmly seated and that...

Страница 40: ...te the clamping ring in the opposite direction close and tight en it 5 4 Remove INTRA LUX head from bases 2307 LN 2320 LN or 2329 LN Rotate the clamping ring in the direction of the arrow to the stop...

Страница 41: ...to ISO 1797 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 leas...

Страница 42: ...missible cutters or grinders Injury to the patient or damage to the medical device Observe the instructions for use and use the cutter or grinder proper ly Only use cutters or grinders that do not dev...

Страница 43: ...or burs Drill bits or burs could fall out during treatment and injure the patient Never use drill bits or burs with worn shafts CAUTION Injury hazard from cutters or grinders Infections or cuts Wear...

Страница 44: ...der is securely held When checking inserting and removing use gloves or a fingerstall to prevent an injury or infec tion Rotate the clamping ring sleeve in the direction of the arrow to the stop and i...

Страница 45: ...system Do not touch the cutter or grinder when it is rotating Remove the cutter grinder from the contra angle handpiece after treat ment to avoid injury and infection when putting it away After the m...

Страница 46: ...3 LN for contra angle drills Note The handpiece must be converted to use contra angle handpiece drill bits Open the handpiece chuck Insert the enclosed drill stop in the chuck Press the contra angle d...

Страница 47: ...r diamond grinders in contra angle 2325 L Note Only use dental burs or diamond drill bits that correspond to ISO 1797 1 type 3 are made of steel or hard metal and meet the following criteria Shaft dia...

Страница 48: ...uctions for use and use the cutter or grinder properly Only use cutters or grinders that do not deviate from the specified da ta CAUTION Injury from using worn cutters or grinders Cutters or grinders...

Страница 49: ...CAUTION Danger of injury from cutters or grinders Infections or cuts Wear gloves or fingerstalls 5 Operation 49 88...

Страница 50: ...grinder to check that the chucking system is okay and the cutter or grinder is securely held When checking inserting and removing use gloves or a fingerstall to prevent an injury or infec tion Forcef...

Страница 51: ...ARNING Hazard from rotating cutter or grinder Lacerations and damage to the chucking system Do not touch rotating cutter or grinder Never press the press button while the cutter or grinder is rotating...

Страница 52: ...After the cutter or grinder has stopped rotating press the press but ton with your thumb and simultaneously pull out the drill bit or bur 5 Operation 52 88...

Страница 53: ...y hose CAUTION Hazard from improper care of the O rings Malfunctions or complete failure of the medical device Do not use Vaseline or other grease or oil Note The O ring on the coupling may only be lu...

Страница 54: ...new O rings into the grooves 6 2 Cleaning the spray nozzle CAUTION Hazard from insufficient amount of spray water Overheating of the medical device and damage to the tooth Check the spray water channe...

Страница 55: ...Clean and free the water passage in the spray nozzles by using the nozzle needle Mat no 0 410 0931 6 Troubleshooting 55 88...

Страница 56: ...is a risk of infection from contaminated medical devices Take suitable personal protective measures Remove all residual cement composite or blood immediately Reprocess the medical device as soon as po...

Страница 57: ...in solutions or the like 7 2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit Defects in the product Only clean manually 7 2 1 Manual external cleaning Accessories required Tap wate...

Страница 58: ...ated external cleaning Not applicable Do not wash the product in thermodisinfectants 7 2 3 Manual internal cleaning Not applicable 7 2 4 Automated internal cleaning Not applicable Do not wash the prod...

Страница 59: ...e to incomplete disinfection Principally KaVo recommends carrying out an final disinfection of the un packaged item if complete disinfection cannot be guaranteed without this measure 7 Reprocessing me...

Страница 60: ...only 7 3 1 Manual external disinfection KaVo recommends the following products based on compatibility of the materials The microbiological efficacy must be ensured by the disinfec tant manufacturer an...

Страница 61: ...wipe down the medical device and leave the disinfectant to soak in according to the instructions from the disinfectant manufacturer Follow the instructions for use of the disinfectant 7 3 2 Manual in...

Страница 62: ...wash the product in thermodisinfectants 7 4 Care products and systems Servicing WARNING Sharp cutters or grinders in the medical device Risk of injury from sharp and or pointed cutters or grinders Rem...

Страница 63: ...t life Perform regular proper care and maintenance Note KaVo only guarantees that its products will function properly when the care products are used that are listed as accessories since they were tes...

Страница 64: ...e i e after each cleaning disinfection and before each sterilisa tion Remove drill or grinder and close the clamping rings on handpiece 2313 LN Cover the product with the Cleanpac bag Place the produc...

Страница 65: ...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 spray Carry out the servicing according to the instructions i...

Страница 66: ...er each cleaning disinfection and before each sterilisa tion Remove drill or grinder and close the clamping rings on handpiece 2313 LN Place the product on the appropriate coupling of the KaVo SPRAYro...

Страница 67: ...104 2104 A is no longer included in the current delivery programme Follow up products QUATTROcare PLUS 2124 A QUATTROcare CLEAN 2140 A Servicing and cleaning device with expansion pressure for the int...

Страница 68: ...as part of the reprocessing after each use i e after each cleaning disinfection and before each sterilisa tion Remove drill or grinder and close the clamping rings on handpiece 2313 LN Servicing the...

Страница 69: ...Note Only possible for the INTRAflex contra angle KaVo recommends cleaning and servicing the chuck system once a week See also 2 Instructions for use KaVo QUATTROcare 2104 2104A 7 Reprocessing method...

Страница 70: ...specified care products and systems See also 2 Servicing with KaVo QUATTROcare 2104 2104A 7 4 4 Servicing with KaVo QUATTROcare PLUS 2124 A Servicing and cleaning device with expansion pressure for th...

Страница 71: ...processing after each use i e after each cleaning disinfection and before each sterilisa tion Remove the milling tool or grinder and close the chuck in the case of handpiece 2313 LN Service the produc...

Страница 72: ...Aflex contra angle KaVo recommends cleaning and servicing the chuck system once a week using the collet servicing program integrated in the device See also 2 Instructions for Use KaVo QUATTROcare PLUS...

Страница 73: ...upling chuck from the side hatch of the QUAT TROcare PLUS and attach it to coupling service point four on the far right A MULTIflex adaptor must be mounted there Press the handpiece together with the...

Страница 74: ...ndpieces in the QUATTROcare PLUS 2124 A close the front door and start theservice procedure Option 2 After three minutes with no service procedure running the de vice automatically switches back to no...

Страница 75: ...turbines KaVo recommends servicing the product as part of the reprocessing after each use i e after each cleaning disinfection and before each sterilisa tion Remove the drill or grinder and close the...

Страница 76: ...Only possible for the INTRAflex contra angle KaVo recommends cleaning and servicing the chuck system once a week using the collet servicing program integrated in the device See also 2 Instructions for...

Страница 77: ...hat 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 i...

Страница 78: ...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 KaVo...

Страница 79: ...cycle The KaVo medical device has a maximum temperature resistance of up to 138 280 4 F Select a suitable procedure depending on the available autoclave from the following sterilisation processes Aut...

Страница 80: ...F Use according to the manufacturer s Instructions for Use 7 7 Storage Prepared products must be stored protected from germs as far as possi ble and dust in a dry dark cool room Note Comply with the...

Страница 81: ...ial sum mary Mat No INTRAflex LUX reducing shanks 2307 LN 2320 LN 2329 LN INTRAflex LUX hand piece 2313 LN INTRAflex LUX contra angle hand piece 2325 LN Instrument stand 2151 0 411 9501 X X X Insert f...

Страница 82: ...2320 LN 2329 LN INTRAflex LUX hand piece 2313 LN INTRAflex LUX contra angle hand piece 2325 LN Cellulose pad 100 units 0 411 9862 X X X Cleanpac 10 units 0 411 9691 X X X Nozzle pin 0 410 0931 X X X S...

Страница 83: ...LN INTRAflex LUX hand piece 2313 LN INTRAflex LUX contra angle hand piece 2325 LN Drill stop 0 524 0892 X Hook 0 410 1633 X Material summary Mat no KaVo Spray 2112 A 0 411 9640 ROTAspray 2142 A 0 411...

Страница 84: ...h a free re placement or repair Other claims of any nature whatsoever in particular with respect to compensation are excluded In the event of default gross negligence or intent this shall only apply i...

Страница 85: ...ss 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 authorised by K...

Страница 86: ...9 Terms and conditions of warranty 86 88...

Страница 87: ......

Страница 88: ...1 005 3683 kb 20141204 07 en...

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