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KaVo 1.003.7714, Instructions For Use Manual

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KaVo 1.003.7714 Instructions For Use Manual Download Page 19

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

by a knowledgeable user. The following must be observed:

▪ the applicable health 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 operating correctly,

▪ use the equipment for the proper purpose,

▪ protect him or herself, the patient and third parties from danger, and

▪ avoid contamination from the product.

Safety

17

Summary of Contents for 1.003.7714

Page 1: ...Instructions for use INTRAcompact contra angle 2061 CHC REF 1 003 7714 ...

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: ...uctions 6 1 1 Terms and conditions of warranty 9 2 Safety 12 2 1 Description of safety instructions 12 2 2 Purpose Proper use 16 2 3 Safety instructions 18 3 Product description 24 3 1 Technical Specifications 25 Content 1 ...

Page 4: ...tation and storage conditions 27 4 First use 29 5 Operation 30 5 1 Attaching the medical device 30 5 2 Removing the medical device 33 5 3 Inserting the file 34 5 4 Removing the file 39 5 5 Application 41 Content 2 ...

Page 5: ... use 44 6 2 Cleaning 45 6 2 1 Cleaning Manual external cleaning 46 6 2 2 Cleaning Automated external cleaning 48 6 2 3 Cleaning Manual internal cleaning 49 6 2 4 Cleaning Automated internal cleaning 51 6 3 Disinfection 52 6 3 1 Disinfection Manual external disinfection 53 Content 3 ...

Page 6: ...Drying 57 6 5 Care products and systems Servicing 59 6 5 1 Care products and systems Servicing Servicing with KaVo Spray 61 6 5 2 Care products and systems Servicing Servicing with KaVo SPRAYrotor 62 6 5 3 Care products and systems Servicing Servicing with KaVo QUATTROcare 63 6 6 Packaging 65 6 7 Sterilisation 66 Content 4 ...

Page 7: ...6 8 Storage 69 7 Tools and consumables 71 Content 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 Refer to the Chapter on Safety Warning symbol Important information for users and service technicians Action request User instructions 7 ...

Page 10: ...mark European Community A product bearing this mark meets the requirements of the applicable EC directive Can be steam sterilised at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Thermodisinfectable User instructions 8 ...

Page 11: ...1 Terms and conditions of warranty The following warranty conditions apply to this KaVo medical device KaVo provides the end customer with a warranty of proper function and guarantees zero defects in respect of material and processing for a period of 12 months from the date of the invoice subject to the following conditions User instructions 9 ...

Page 12: ... consequences that have arisen or may arise from natural wear improper handling cleaning or maintenance non compliance with operating mainte nance or connection instructions calcination or corrosion contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in accordance with KaVo s in structions for use or other manufacturer s instructions The warranty g...

Page 13: ...the customer or a third party that is not authorised by KaVo 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 or note of delivery The dealer purchase date type and serial number must be clearly evident from this document User instructions 11 ...

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

Page 15: ...ANGER The introduction describes the type and source of the hazard This section describes the potential consequences of non observance The optional step includes necessary measures for hazard prevention Safety 13 ...

Page 16: ...afety 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 to moderate injuries Safety 14 ...

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

Page 18: ...tment only Any other type of use or alteration to the product is imper missible and can be hazardous The medical device is intended for the following uses cavity preparation caries excavation A medical device according to relevant national statutory regulations Safety 16 ...

Page 19: ...th 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 operating correctly use the equipment for the proper purpose protect him or herself the patient and third parties from danger and avoid contamination from the product Safety 17 ...

Page 20: ...WARNING Hazard to the care provider and patient In case of damage irregular noise during operation excessive vibration atypical heating or when the file cannot be firmly held Stop working and contact service support Safety 18 ...

Page 21: ...e 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 to responsibilities arising from safety reliability and performance The medical device may only be combined with a treatment centre released by KaVo Safety 19 ...

Page 22: ...CAUTION Risk due to incorrectly stored handpiece Injury and infection from clamped files After treatment place the handpiece properly in the holder without the file Safety 20 ...

Page 23: ...CAUTION Burning hazard from hot handpiece head and handpiece cover Burn injuries in the mouth may be caused if the handpiece overheats Never touch soft tissue with the handpiece head Safety 21 ...

Page 24: ...age during long periods of nonuse Reduced product life The medical device should be cleaned serviced and stored in a dry location according to instructions before long periods of nonuse Note Before each treatment insert a dental dam for safety reasons Safety 22 ...

Page 25: ...ing methods 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 to clean service and check the functioning of the medical device This service interval should take into account the frequency of use Service may only be carried out by KaVo trained repair ...

Page 26: ...3 Product description INTRAcompact contra angle handpiece 2061 CHC Mat no 1 003 7714 Product description 24 ...

Page 27: ...chnical Specifications Drive speed max 20 000 min 1 Axial stroke movement 0 8 mm Identification 1 yellow ring Transmission ratio 1 1 36 latched positions Shock absorption due to spring Product description 25 ...

Page 28: ...0 8 mm A rotational movement inside the handpiece is converted to a damped axial stroke movement Product description 26 ...

Page 29: ...SO 3964 DIN 13940 3 2 Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored refrigerated This can cause the medical device to malfunction Prior to start up very cold products must be heated to a temperature of 20 C to 25 C 68 F to 77 F Product description 27 ...

Page 30: ...Temperature 20 C to 70 C 4 F to 158 F Relative humidity 5 RH to 95 RH absence of condensation Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 28 ...

Page 31: ...4 First use WARNING Hazard from non sterile products Infection hazard for care provider and patient Before first use and after each use sterilise the medical device First use 29 ...

Page 32: ...ical device during treatment A medical device that is not properly locked in place can become disconnected from the motor coupling and fall off Carefully pull on the medical device before each treatment to ensure that it is securely locked onto the motor coupling Operation 30 ...

Page 33: ...TION Removing and attaching the contra angle handpiece while the drive motor is rotating Damage to the drive Never attach or remove the contra angle handpiece while the drive motor is rotating Operation 31 ...

Page 34: ... Place the medical device on the LUX motor coupling and lock it into place Operation 32 ...

Page 35: ...he medical device to check that it is securely seated in the motor coupling 5 2 Removing the medical device Unlock the medical device from the LUX motor coupling by twisting it slightly and then pulling it along its axis Operation 33 ...

Page 36: ...5 3 Inserting the file Note Manufacturer of files Intensiv Operation 34 ...

Page 37: ...WARNING Use of non approved files Injury to the patient or damage to the medical device Only use files that do not deviate from the specified data Operation 35 ...

Page 38: ...CAUTION Danger of injury from files Infections or cuts Wear gloves or finger stalls Operation 36 ...

Page 39: ... Push the file into the segment in the retaining bore in the head and press it against the stop Check that the tool is seated securely by pulling on it Operation 37 ...

Page 40: ... Turn the knurled wheel to fix the file 36 individual locking positions can be selected Operation 38 ...

Page 41: ...r from axial movement of file Lacerations Do not touch file when moving in axial direction Never eject file while in mouth Remove the file from the medical device after treatment to avoid injury and infection during storage Operation 39 ...

Page 42: ... When the file has stopped moving push file out of the head with ejector and remove it Operation 40 ...

Page 43: ...tensiv in the following areas finishing box preparations with the Cavishape file bevelling edges in composite fillings and in onlay and in margin finishing for crown prepara tions with the Bevelshape file and the removal of proximal filling surfaces and crown margins with the Proxshape file Operation 41 ...

Page 44: ...heating of the tooth due to insufficient amount of cooling water Thermal damage to the dental pulp Ensure that the water spray is ample Note Before each treatment insert a dental dam for safety reasons Operation 42 ...

Page 45: ... Use files with light pressure For the specific method of operation please refer to the description contained in the respective file kit Operation 43 ...

Page 46: ...he site of use WARNING Hazard from nonsterile products There is a risk of infection from contaminated medical devices Take suitable personal protective measures Remove residual cement composite or blood at the site of use Reprocessing methods according to ISO 17664 44 ...

Page 47: ... it in a solution or similar Recondition the medical device as soon as possible after treatment 6 2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit Defects in the product Only clean manually or in a thermodisinfector Reprocessing methods according to ISO 17664 45 ...

Page 48: ...6 2 1 Cleaning Manual external cleaning Accessories required Tap water 30 C 5 C 86 F 10 F Brush e g medium hard toothbrush Reprocessing methods according to ISO 17664 46 ...

Page 49: ... Brush off under flowing tap water Reprocessing methods according to ISO 17664 47 ...

Page 50: ...h the program VARIO TD the detergent neodisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the material compatibility with KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector Reprocessing methods according to ISO 17664 48 ...

Page 51: ...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 Afterwards rinse for 3 5 seconds with KaVo DRYspray See also KaVo CLEANspray KaVo DRYspray Instructions for Use Reprocessing methods according to ISO ...

Page 52: ...ing countries 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 Reprocessing methods according to ISO 17664 50 ...

Page 53: ...h the program VARIO TD the detergent neodisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the material compatibility with KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector Reprocessing methods according to ISO 17664 51 ...

Page 54: ... 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 Reprocessing methods according to ISO 17664 52 ...

Page 55: ...nual external disinfection KaVo recommends the following products based on material compatibility The microbiological ef ficacy must be ensured by the disinfectant manufacturer Reprocessing methods according to ISO 17664 53 ...

Page 56: ...e by Metrex Consumables required Cloths for wiping off the medical device Spray the disinfectant on a cloth then wipe down the medical device and allow the disinfectant to act according to the instructions of the disinfectant manufacturer Reprocessing methods according to ISO 17664 54 ...

Page 57: ...rnal disinfection 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 interior of this product is not designed for manual disinfection Reprocessing methods according to ISO 17664 55 ...

Page 58: ...formed with the program VARIO TD the detergent neodisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the material compatibility with KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector Reprocessing methods according to ISO 17664 56 ...

Page 59: ...stems provided by KaVo 6 4 Drying Manual Drying Blow off the outside and inside with compressed air until water drops are no longer visible Automatic Drying The drying procedure is normally part of the cleaning program of the thermodisinfector Reprocessing methods according to ISO 17664 57 ...

Page 60: ...Note Please observe the instructions for use of the thermodisinfector Reprocessing methods according to ISO 17664 58 ...

Page 61: ...6 5 Care products and systems Servicing CAUTION Sharp files in the medical device Danger of injury from sharp and or pointed files Remove the file Reprocessing methods according to ISO 17664 59 ...

Page 62: ...Reduced product life Perform proper care regularly Note KaVo only 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 Reprocessing methods according to ISO 17664 60 ...

Page 63: ...servicing the product after each time it is used i e after each automatic cleaning and before each sterilisation Remove file Cover the product with the Cleanpac bag Place the product on the cannula and press the spray button for one second Reprocessing methods according to ISO 17664 61 ...

Page 64: ...ms Servicing Servicing with KaVo SPRAYrotor KaVo recommends servicing the product after each time it is used i e after each automatic cleaning and before each sterilisation Remove file Reprocessing methods according to ISO 17664 62 ...

Page 65: ...ith a Cleanpac bag Servicing the product See also Instructions for use KaVo SPRAYrotor 6 5 3 Care products and systems Servicing Servicing with KaVo QUATTROcare Cleaning and care unit with expansion pressure for effective cleaning and care Reprocessing methods according to ISO 17664 63 ...

Page 66: ...KaVo recommends servicing the product after each time it is used i e after each automatic cleaning and before each sterilisation Remove file Reprocessing methods according to ISO 17664 64 ...

Page 67: ...ag is not stretched The quality and use of the sterilisation 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 STERI clave bags Mat no 0 411 9912 Reprocessing methods according to ISO 17664 65 ...

Page 68: ... Autoclave 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 care products Reprocessing methods according to ISO 17664 66 ...

Page 69: ...CAUTION Contact corrosion due to moisture Damage to product Immediately remove the product from the steamsteriliserafter the sterilisation cycle Reprocessing methods according to ISO 17664 67 ...

Page 70: ...istance up to 138 280 4 F KaVo recommends e g STERIclave B 2200 2200P from KaVo Citomat K series from Getinge Depending on the device select a suitable process from the following sterilisation processes Reprocessing methods according to ISO 17664 68 ...

Page 71: ...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 Comply with the manufacturer s instructions for use with regard to the application range 6 8 Storage Prepared products must be stored protected from germs as far as possible and dust in a dry dark cool room Reprocessing methods according to ISO 17664 69 ...

Page 72: ...Note Comply with the expiry date of the sterilised items Reprocessing methods according to ISO 17664 70 ...

Page 73: ...ainable from the dentalmed specialist supplier Material summary Mat no Handpiece stand 2151 0 411 9501 Cleanpac 10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 File kit 0 220 2826 Pusher 0 410 0634 Tools and consumables 71 ...

Page 74: ...Material summary Mat no KaVo CLEANspray 1 007 0579 KaVo DRYspray 1 007 0580 KaVo Spray 2112 A 0 411 9640 ROTAspray 2142 A 0 411 7520 QUATTROcare plus Spray 2108 P 1 005 4525 Tools and consumables 72 ...

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