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KaVo 1.003.7191, Instructions For Use Manual, Page: 19 / 84

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KaVo 1.003.7191 Instructions For Use Manual Download Page 19

2.2

   

Purpose – Intended use

This medical device is

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

to the product is impermissible and can be hazardous. The medical

device is intended for the following uses: Endodontics and cavity

preparation.

▪ a medical device according to relevant national statutory regulations.

Safety

17

Summary of Contents for 1.003.7191

Page 1: ...Instructions for use INTRA LUX head 66 LU REF 1 004 4587 INTRA LUX head 68 LU REF 1 003 7191 ...

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

Page 3: ...tructions 6 1 1 Warranty terms and conditions 9 2 Safety 12 2 1 Description of safety instructions 12 2 2 Purpose Intended use 17 2 3 Safety instructions 19 3 Product description 25 3 1 Technical Data 66 LU 27 Contents 1 ...

Page 4: ...e conditions 29 4 First use 31 5 Operation 32 5 1 Attaching the medical device 32 5 2 Removing the medical device 34 5 3 Inserting contra angle handpiece drill bits or endodon tic files 35 5 4 Removing contra angle handpiece drill bits or files 42 Contents 2 ...

Page 5: ... 45 6 2 Cleaning 47 6 2 1 Cleaning Manual cleaning external 48 6 2 2 Cleaning Automated external cleaning 50 6 2 3 Cleaning Manual cleaning of the inside 51 6 2 4 Cleaning Automated internal cleaning 54 6 3 Disinfection 55 6 3 1 Disinfection Manual disinfection external 56 Contents 3 ...

Page 6: ...nfection Automatic External and InternalDisinfection 59 6 4 Drying 60 6 5 Care products and systems Servicing 62 6 5 1 Care products and systems Servicing Care with KaVo Spray 65 6 5 2 Care products and systems Servicing Care of the KaVo SPRAYrotor 68 Contents 4 ...

Page 7: ...6 5 3 Care products and systems Servicing Care with KaVo QUATTROcare 70 6 6 Packaging 73 6 7 Sterilisation 74 6 8 Storage 77 7 Tools 79 Contents 5 ...

Page 8: ...tions Dear User Congratulations on purchasing this KaVo quality product By following the instructions below you will be able to work smoothly economically and safely Copyright by KaVo Dental GmbH User instructions 6 ...

Page 9: ...Symbols See the Safety Warning Symbols chapter Important information for users and technicians Disinfectable by heat Steriliseable in steam up to 135 C 275 F User instructions 7 ...

Page 10: ...h this mark meets the requirements of the applicable EC directive Call to Action Target group This document is intended for dentists and their assistants The section on starting up is also intended for service technicians User instructions 8 ...

Page 11: ...ing for a period of 12 months from data of invoice subject to the following conditions In case of justified complaints KaVo will honour its warranty with a free replacement 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 in the absence of mandatory legal regulations to t...

Page 12: ...nnection instructions calcination or corrosion contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in ac cordance with KaVo s instructions for use or other manufacturer s instruc tions No liability is assumed when defects or their consequences are derived from manipulations or changes to the product by the customer or a third party User instruction...

Page 13: ...Service warranty claims will only be accepted if the product is submitted along with proof of purchase in the form of a copy of the invoice delivery note User instructions 11 ...

Page 14: ...2 Safety 2 1 Description of safety instructions Warning symbol Safety 12 ...

Page 15: ...DANGER The introduction describes the type and source of the danger This section describes the potential consequen ces of non observance The optional step covers measures necessary for avoiding hazards Safety 13 ...

Page 16: ...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 mild or moderate phys ical harm Safety 14 ...

Page 17: ...WARNING WARNING indicates a hazardous situation that can cause death or serious injury Safety 15 ...

Page 18: ...DANGER DANGER indicates the maximum hazard level indicates a directly hazardous situation that can cause death or serious injury Safety 16 ...

Page 19: ...tal treatment Any other type of use or alteration to the product is impermissible and can be hazardous The medical device is intended for the following uses Endodontics and cavity preparation a medical device according to relevant national statutory regulations Safety 17 ...

Page 20: ...cable 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 use the equipment for the proper purpose protect him or herself the patient and third parties from danger avoid contamination from the product Safety 18 ...

Page 21: ...RNING Hazards for the care provider and the patient In the case of damage irregular running noise excessive vibration un typical warming or when the drill bit or bur cannot be held Do not use further and notify Service Safety 19 ...

Page 22: ...jury and infection caused by chucked contra angle handpiece drill bits or files Damage can be caused to the chucking system if the instrument is dropped After treatment place the instrument properly in the cradle without the contra angle handpiece drill bit or file Safety 20 ...

Page 23: ...CAUTION Burning hazard from hot instrument head and instrument cover If the instrument overheats burns may arise in the oral area Never touch soft tissue with the instrument head Safety 21 ...

Page 24: ...alfunctioning from im proper storage during long periods of nonuse Reduced product life The medical device should be cleaned serviced and stored in a dry location according to instruc tions before long periods of nonuse Safety 22 ...

Page 25: ...The following individuals are authorized to repair and service KaVo prod ucts Technicians at KaVo branches throughout the world Technicians specially trained by KaVo To ensure proper function the medical device must be set up according to the methods described in the KaVo instructions for use and the care prod Safety 23 ...

Page 26: ...dental office for a licensed shop to clean service and check the functioning of the medical device This service in terval should take into account the frequency of use Service may only be provided by repair shops that have undergone training by KaVo and that use original KaVo replacement parts Safety 24 ...

Page 27: ...3 Product description INTRA LUX reducing head 66 LU Mat no 1 004 4587 Product description 25 ...

Page 28: ...INTRA LUX Head 68 LU Mat no 1 003 7191 Product description 26 ...

Page 29: ...speed max 20 000 rpm 1 Identification green Transmission 3 1 With press button chuck Contra angle handpiece drill bits and root canal instruments can be used The head can be inserted in all KaVo reducing shanks Product description 27 ...

Page 30: ... Data 68 LU Drive speed max 40 000 rpm identification blue Transmission 1 1 With press button chuck Contra angle handpiece bits can be used The head can be inserted in all KaVo reducing shanks Product description 28 ...

Page 31: ...ON Starting up the medical device can be hazard ous after it has been stored in an excessively cold location The medical device can malfunction Products that are very cold must be warmed to 20 C to 25 C 68 F to 77 F before use Product description 29 ...

Page 32: ...Temperature 20 C to 70 C 4 F to 158 F Relative humidity non condensing 5 to 95 Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 30 ...

Page 33: ...4 First use WARNING Hazard from non sterile products Infection danger to the care provider and pa tient Before first use and after each use sterilise the medical device First use 31 ...

Page 34: ...5 Operation 5 1 Attaching the medical device CAUTION Loosening of the medical device during treat ment If the head is not properly locked in place it can fall out during treatment Operation 32 ...

Page 35: ...e each treatment check that the head is firmly seated and that the clamping ring is tight Rotate the clamping ring in the direction of the arrow to the stop Insert the medical device to the stop Make sure that the catches are properly seated Operation 33 ...

Page 36: ...ing in the opposite direction and tighten it 5 2 Removing the medical device Hold the clamping ring tight turn it all the way in the direction of the arrow and pull the medical device off while twisting slightly Operation 34 ...

Page 37: ...es Note Only use contra angle drill bits or Endo files that corre spond to ISO 1797 1 type 1 and ISO 3630 1 shaft diameter 2 334 to 2 35 mm Contra angle drill bit for INTRA LUX reducing head 66 LU overall length max 22 mm shaft clamping length min 12 mm Operation 35 ...

Page 38: ...ing diameter max 5 mm Contra angle drill bit for INTRA LUX head 68 U overall length max 22 mm Endo file for INTRA LUX reducing head 66 LU overall length max 45 mm shaft clamping length min 12 mm Operation 36 ...

Page 39: ...se of non approved contra angle handpiece drill bits or files Injury to the patient or damage to the medical device Only use contra angle handpiece drill bits or files that match the indicated data Operation 37 ...

Page 40: ... worn contra angle handpiece drill bits or files Contra angle handpiece drill bits or files can fall out during treatment and injure the patient Never use contra angle handpiece drill bits or files with worn shafts Operation 38 ...

Page 41: ...CAUTION Danger of injury from contra angle handpiece drill bits or files Infections or cuts Wear gloves or finger protection Operation 39 ...

Page 42: ...ll out and cause injury Pull on the contra angle handpiece drill bit or file to check if the chucking system is okay and the contra angle handpiece drill bit or file is securely held For checking inserting and removing use gloves or finger protection to prevent any injury or infection Operation 40 ...

Page 43: ... Insert the contra angle handpiece drill bit or file into the segment of the head drive by twisting the tool slightly and push to the stop Check that the tool is seated by pulling on it Operation 41 ...

Page 44: ...r files WARNING Hazard from rotating drill bit or file Lacerations and damage to the chucking sys tem Do not touch rotating contra angle drill bit or file Do not press the pushbutton while the contra an gle drill bit or file is rotating Operation 42 ...

Page 45: ... Remove the contra angle drill bit or file from the contra angle handpiece after treatment to avoid injury and infection during storage Operation 43 ...

Page 46: ...After the contra angle handpiece drill bit or file has stopped rotating forcefully press the pushbutton with your thumb and simultaneously remove the contra angle handpiece drill bit or file Operation 44 ...

Page 47: ...O 17664 6 1 Preparations at the site of use WARNING Hazard from non sterile products There is a risk of infection from contaminated medical devices Observe suitable personal protective measures Preparation methods according to ISO 17664 45 ...

Page 48: ...ry the medical device before transporting it to be prepared Do not place it in a solution or the like Prepare the medical device directly after treatment Remove the contra angle drill bit or file from the medical device Preparation methods according to ISO 17664 46 ...

Page 49: ...6 2 Cleaning CAUTION Malfunctions from cleaning in an ultrasonic unit Defects in the product Only clean manually or in a thermodisinfector Preparation methods according to ISO 17664 47 ...

Page 50: ...6 2 1 Cleaning Manual cleaning external Required accessories Tap water 30 C 5 C 86 F 10 F Brush such as a medium hard toothbrush Preparation methods according to ISO 17664 48 ...

Page 51: ... Brush off under flowing tap water Preparation methods according to ISO 17664 49 ...

Page 52: ... the program VARIO TD the detergent neodisher mediclean the neutraliser neodisher Z and rinse neodish er mielclear and only refers to the material compatibility with KaVo prod ucts The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Preparation methods according to ISO 17664 50 ...

Page 53: ...ide Can only be done with KaVo CLEANspray or KaVo DRYspray Cover the medical device with the KaVo CLEANpac bag and place it on the corresponding care adapter Press the spray button three times for 2 seconds each time Remove the medical device from the spray attachment and let the cleaner work for one minute Preparation methods according to ISO 17664 51 ...

Page 54: ... Afterwards rinse for 3 5 seconds with KaVo DRYspray See also KaVo CLEANspray KaVo DRYspray Instructions for Use Preparation methods according to ISO 17664 52 ...

Page 55: ...ing coun tries Germany Austria Switzerland Italy Spain Portugal France Luxembourg Belgium Netherlands United Kingdom Denmark Sweden Finland and Norway In other countries only automated interior cleaning with thermodisinfectors in accordance with ISO 15883 1 Preparation methods according to ISO 17664 53 ...

Page 56: ... the program VARIO TD the detergent neodisher mediclean the neutraliser neodisher Z and rinse neodish er mielclear and only refers to the material compatibility with KaVo prod ucts The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Preparation methods according to ISO 17664 54 ...

Page 57: ... care products and systems provided by KaVo 6 3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine Defects in the product Only disinfect in a thermodisinfector or manually Preparation methods according to ISO 17664 55 ...

Page 58: ...nual disinfection external KaVo recommends the following products based on material compatibility The microbiological efficacy must be ensured by the disinfectant manufac turer Preparation methods according to ISO 17664 56 ...

Page 59: ...ex Tools required Cloths for wiping off the medical device Spray the disinfectant on a cloth then thoroughly wipe down the medical device and leave the disinfectant to soak in according to the instructions of the disinfectant manufacturer Preparation methods according to ISO 17664 57 ...

Page 60: ... disinfection internal For the effective re preparation the inside of the device must be cleaned automatically in a cleaning and disinfection unit in accordance with ISO 15883 1 The inside of this product should not be disinfected manually Preparation methods according to ISO 17664 58 ...

Page 61: ...ormed with the program VARIO TD the detergent neodisher mediclean the neutraliser neodisher Z and rinse neodish er mielclear and only refers to the material compatibility with KaVo prod ucts The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Preparation methods according to ISO 17664 59 ...

Page 62: ...reat the medical device with the care products and systems provided by KaVo 6 4 Drying Manual drying Blow off the outside and inside with compressed air until water drops are no longer visible Preparation methods according to ISO 17664 60 ...

Page 63: ...rying The drying procedure is normally part of the cleaning program of the ther modisinfector Note Please observe the instructions for use of the thermo disinfector Preparation methods according to ISO 17664 61 ...

Page 64: ...harp contra angle handpiece drill bits or files in the medical device Injury hazard from sharp and or pointed contra angle handpiece drill bits or files Removing contra angle handpiece drill bits or files Preparation methods according to ISO 17664 62 ...

Page 65: ...CAUTION Premature wear and malfunctions from improp er servicing and care Reduced product life Perform proper care regularly Preparation methods according to ISO 17664 63 ...

Page 66: ...nly guarantees that its products will function properly when the care products used are those listed as accessories as they were tested for proper use on our products Preparation methods according to ISO 17664 64 ...

Page 67: ...ems Servicing Care with KaVo Spray KaVo recommends servicing the project after each time it used i e after each automatic cleaning and before each sterilisation Remove head from shank Preparation methods according to ISO 17664 65 ...

Page 68: ...e the contra angle drill bit or file Cover the product with the CLEANpac bag Place the product on the cannula and press the spray button for one second Chuck care Preparation methods according to ISO 17664 66 ...

Page 69: ...huck system once a week Remove the drill bit or file and spray into the opening with the tip of the spray nipple Note Carry out servicing according to instructions in the sec tion Care with KaVo Spray Preparation methods according to ISO 17664 67 ...

Page 70: ... Servicing Care of the KaVo SPRAYrotor KaVo recommends servicing the project after each time it used i e after each automatic cleaning and before each sterilisation Remove head from shank Preparation methods according to ISO 17664 68 ...

Page 71: ...the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a CLEANpac bag Servicing the product See also Instructions for use KaVo SPRAYrotor Preparation methods according to ISO 17664 69 ...

Page 72: ...ATTROcare Cleaning and care unit with expansion pressure for effective cleaning and care KaVo recommends servicing the project after each time it used i e after each automatic cleaning and before each sterilisation Preparation methods according to ISO 17664 70 ...

Page 73: ...e the contra angle drill bit or file Servicing the product Chuck care KaVo recommends cleaning and servicing the chuck system once a week See also Instructions for use KaVo QUATTROcare Preparation methods according to ISO 17664 71 ...

Page 74: ...drill bit or bur place the spray nipple tip in the opening and spray Subsequently treat with the care products and systems specified See also Care with KaVo QUATTROcare Preparation methods according to ISO 17664 72 ...

Page 75: ...retched The quality and use of the sterilised product packaging must satisfy applicable standards and be suitable for the sterilisation procedure Individually weld the medical device in the sterilised item packaging such as KaVo STERIclave bags Mat no 0 411 9912 Preparation methods according to ISO 17664 73 ...

Page 76: ...ation Sterilisation in a steam steriliser Autoclave EN 13060 ISO 17665 1 CAUTION Premature wear and malfunctions from improp er servicing and care Reduced product life Preparation methods according to ISO 17664 74 ...

Page 77: ...ce the medi cal device with KaVo care products CAUTION Contact corrosion due to moisture Damage to product Immediately remove the product from the steam steriliser after the sterilisation cycle Preparation methods according to ISO 17664 75 ...

Page 78: ...up to 138 280 4 F KaVo recommends for example STERIclave B 2200 2200P from KaVo Citomat K series from Getinge Depending on the device select a suitable process from the following ster ilisation processes Preparation methods according to ISO 17664 76 ...

Page 79: ...en minutes at 134 C 1 C 273 F 1 8 F Autoclave with gravitation process for at least 60 minutes at 121 C 1 C 250 F 1 8 F Follow the manufacturer s instructions for use 6 8 Storage Prepared products must be stored protected from germs as far as possi ble and dust in a dry dark cool room Preparation methods according to ISO 17664 77 ...

Page 80: ...Note Observe the expiration date of the sterilised item Preparation methods according to ISO 17664 78 ...

Page 81: ...al and medical suppliers Material summary Mat no Instrument stand 2151 0 411 9501 Cleanpac 10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 Material summary Mat no KaVo CLEANspray 1 007 0579 KaVo DRYspray 1 007 0580 Tools 79 ...

Page 82: ...Material summary Mat no KaVo Spray 2112 A 0 411 9640 ROTAspray 2142 A 0 411 7520 QUATTROcare plus Spray 2108 P 1 005 4525 Tools 80 ...

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