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KaVo 1.000.4243, Instructions For Use Manual

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KaVo 1.000.4243 Instructions For Use Manual Download Page 13

DANGER

DANGER

indicates a hazardous situation that can directly cause death or serious

injury.

2.2   Purpose – Proper 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 SONICflex can be used in conjunction with KaVo tips for plaque

removal, prophylaxis, endodontics, periodontology, surgery and con‐

servative dentistry.

▪ A medical device according to relevant national statutory regulations.

 

 

Safety

11

Summary of Contents for 1.000.4243

Page 1: ...Instructions for use SONICflex 2003 REF 1 000 4246 SONICflex LUX 2003 L REF 1 000 4243 ...

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: ...cription of safety instructions Warning symbol 9 2 1 2 Description of safety instructions Structure 9 2 1 3 Description of safety instructions Description of danger levels 10 2 2 Purpose Proper use 11 2 3 Safety instructions 13 2 3 1 Safety instructions SONICflex tips 16 3 Product description 19 3 1 Technical data 20 Contents 1 ...

Page 4: ...MULTIflex and MULTIflex LUX coupling 27 4 3 Check O rings 27 4 4 Check the pressure 28 5 Operation 30 5 1 Attaching SONICflex 30 5 2 Removing SONICflex 32 5 3 Inserting SONICflex tip 33 5 4 Removing SONICflex tip 35 5 5 Power setting 36 5 6 Regulating spray 36 5 7 Check the amount of water 37 Contents 2 ...

Page 5: ...leaning Manual cleaning internal 42 6 2 4 Cleaning Automated internal cleaning 44 6 3 Disinfection 45 6 3 1 Disinfection Manual disinfection external 46 6 3 2 Disinfection Manual disinfection internal 47 6 3 3 Disinfection Machine disinfection external and internal 48 6 4 Drying 49 6 5 Care products and systems Servicing 50 6 5 1 Care products and systems Servicing Torque wrench care 52 Contents 3...

Page 6: ... Care with KAVOspray 54 6 5 3 Care products and systems Servicing Care of the KaVo SPRAYrotor 55 6 5 4 Care products and systems Servicing Care with KaVo QUATTROcare 56 6 6 Packaging 57 6 7 Sterilisation 58 6 8 Storage 60 7 Tools 62 Contents 4 ...

Page 7: ...KaVo 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 Safety Warning symbol chapter Important information for users and service technicians User instructions 5 ...

Page 8: ... 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 Target group This document is intended for dentists and their assistants The section on starting up is also intended for service technicians User instructions 6 ...

Page 9: ...pair 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 the contrary KaVo cannot be held liable for defects and their consequences that have arisen or may arise from to natural wear improper handling cleaning or maintenance non complia...

Page 10: ...rived from manipulations or changes to the product by the customer or a third party 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 The dealer purchase date type and serial number must be clearly visible on this document User instructions 8 ...

Page 11: ...g symbol 2 1 2 Description of safety instructions Structure DANGER 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 preven tion Safety 9 ...

Page 12: ...ed 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 WARNING WARNING indicates a hazardous situation that can cause death or serious injury Safety 10 ...

Page 13: ...ntended for dental treatment Any other type of use or alteration to the product is impermissible and can be hazardous The SONICflex can be used in conjunction with KaVo tips for plaque removal prophylaxis endodontics periodontology surgery and con servative dentistry A medical device according to relevant national statutory regulations Safety 11 ...

Page 14: ...ble 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 and avoid contamination from the product Safety 12 ...

Page 15: ...nd patient Stop working in case of damage irregular noise during operation exces sive vibration unusual build up of heat or if the tip cannot be firmly held The instrument must be cleaned serviced and stored dry if it has not been used for a long period Safety 13 ...

Page 16: ... ment tip becomes loose Stop work and seek service support CAUTION Premature wear and malfunctioning from improper storage 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 Safety 14 ...

Page 17: ...st injury To ensure proper function the medical device must be set up according to the reprocessing 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 depen...

Page 18: ... 1 Safety instructions SONICflex tips CAUTION Risk of injury and infection when changing the SONICflex tips This can substantially endanger the user To test use and remove the SONICflex tips use a glove or other finger protection Note We recommend replacing the SONICflex tips every 9 12 months Safety 16 ...

Page 19: ...d Mat no 1 001 6958 The tips may break from continuous stress or damage such as being drop ped on the floor or being bent Therefore check the tip to see if it is safe before each use by applying a slight amount of pressure with your thumb or index finger Safety 17 ...

Page 20: ... For an additional safety check mechanically apply approx 10 N 1 kg to the tip without operating the device Safety 18 ...

Page 21: ...3 Product description SONICflex 2003 Mat no 1 000 4246 SONICflex LUX 2003 L Mat no 1 000 4243 Product description 19 ...

Page 22: ...espective application The internal water cooling spray cooling prevents the treatment field from heating up and keeps the treatment surface clean Note The device should be operated with the described operating pressure Af ter starting the intensity can be regulated using the foot switch at maxi mum drive pressure 3 1 Technical data Drive pressure 2 5 29 to 4 2 44 bar psi Air consumption 20 40 NL m...

Page 23: ... MULTIflex couplings Oscillation level 1 120 15 μm Oscillation level 2 160 15 μm Oscillation level 3 240 15 μm CAUTION Observe the SONICflex recommended setting Non compliance with the recommendations can endanger the patient When using level 3 the recommended settings must be observed Product description 21 ...

Page 24: ...ice after it 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 temperature of 20 C to 25 C 68 F to 77 F Temperature 20 C to 70 C 4 F to 158 F Relative humidity 5 RH to 95 RH Product description 22 ...

Page 25: ...Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 23 ...

Page 26: ...hylaxis endodontics periodontology surgery and conservative dentistry The amount of water needs to be set on the dental unit so that the instru ment tip sprays the water with the proper oscillating intensity It is important to remove all the plaque to ensure satisfactory oral hygiene and thorough periodontological treatment The vibration cleaning of the SONICflex is gentle fast and easy to use Usi...

Page 27: ...f the tooth and guided parallel to the tooth The in strument should be moved parallel to the surface of the tooth and not the edge to prevent forming notches in the tooth substance Professionals rec ommend polishing the tooth surface with the KaVo prophylaxis head using the provided rubber cup and a fine paste to improve the effect of caries prophylaxis First use 25 ...

Page 28: ...ge from soiled and moist cooling air Contaminated and moist cooling air can cause malfunctions and lead to premature bearing wear Make sure that the supply of cooling air is dry clean and unconta minated according to ISO 7494 2 First use 26 ...

Page 29: ...crew the MULTIflex LUX MULTIflex LED coupling onto the turbine hose and tighten with the wrench 4 3 Check O rings CAUTION Missing or damaged O rings Malfunctions and premature failure Make sure that all O rings are on the coupling and undamaged First use 27 ...

Page 30: ...utomatically inside the SONICflex The air consumption is approximately 20 40 NI min Insert the test manometer Mat no 0 411 8731 between the MULTIflex coupling and the SONICflex Pressure displayed Drive air T R 2 5 to 4 2 bar 36 to 61 psi Return air R L 0 4 bar 6 psi Spray air Sp L max 2 29 bar psi Spray air not required however Water W 1 0 to 2 0 bar 15 to 29 psi First use 28 ...

Page 31: ...First use 29 ...

Page 32: ...e SONICflex is tightly seated on the coupling If the SONICflex unintentionally comes off the coupling during treatment it can endanger the patient and user Before each treatment pull on the SONICflex to see if it is securely seated in the coupling Operation 30 ...

Page 33: ...mprecise coupling can destroy the high pressure bulb of a MULTIflex LUX coupling or reduce its life Make sure that the coupling is precise Place the SONICflex precisely on the MULTIflex MULTIflex LUX cou pling and push it to the rear until it locks audibly Operation 31 ...

Page 34: ...5 2 Removing SONICflex Hold the MULTIflex MULTIflex LUX coupling tightly and pull the SONICflex forward while twisting slightly Operation 32 ...

Page 35: ... wrench This may result in a risk of injury for the user When inserting the tip into the torque spanner make sure that the tip s end always faces into the opening of the torque spanner Note In view of the substantial liability risks we recommend using exclusively original KaVo SONICflex tips Operation 33 ...

Page 36: ...it clockwise The torque wrenches are for changing the working tips of the SONICflex and protect against injury The torque wrench can be screwed in more quickly by holding it at the rear thin grip area The large diameter helps tighten and remove it Note The tip is properly gripped when the torque wrench slips Operation 34 ...

Page 37: ...Cflex is in the holder the torque wrench should be placed on the tip to protect against injury 5 4 Removing SONICflex tip Insert attach the torque wrench in on the SONICflex and unscrew the tip anticlockwise Operation 35 ...

Page 38: ...nce levels 1 2 and 3 5 6 Regulating spray Turn the spray ring on the MULITflex LUX MULTIflex LUX coupling in order to regulate the water content The water volume can be regu lated by selecting different stop positions Turn clockwise to reduce the water volume Operation 36 ...

Page 39: ...ease the volume 5 7 Check 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 spray cooling to a minimum of 30 cm3 min Operation 37 ...

Page 40: ... torque wrench and nozzle needle 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 Remove all residual cement composite or blood without delay Preparation methods according to ISO 17664 38 ...

Page 41: ...the like Reprocess the medical device as soon as possible after treatment Remove the tip from the SONICflex using the torque wrench 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 39 ...

Page 42: ...ed Tap water 30 C 5 C 86 F 10 F Brush e g medium hard toothbrush Brush it off under running tap water using for example a medium hard toothbrush Prepare the tip according to the manufacturer s instructions for use Preparation methods according to ISO 17664 40 ...

Page 43: ...her mielclear rinsing agent and extends only to the compatibility of materials with respect to KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector com plying with max pH value of 10 In order to prevent negative effects on the medical device make sure that the interior and the exterior of the medical ...

Page 44: ... 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 Preparation methods according to ISO 17664 42 ...

Page 45: ...bourg Belgium Netherlands United Kingdom Denmark Sweden Fin land and Norway In other countries only automated interior cleaning with thermodisinfec tors in accordance with ISO 15883 1 Note Do not place the tips in the drill bit bath as the fine capillaries would cor rode badly making it impossible to rinse them under running water Preparation methods according to ISO 17664 43 ...

Page 46: ...her mielclear rinsing agent and extends only to the compatibility of materials with respect to KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector com plying with max pH value of 10 In order to prevent negative effects on the medical device make sure that the interior and the exterior of the medical ...

Page 47: ...tion 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 45 ...

Page 48: ... on material compatibility The microbiological efficacy must be ensured by the disinfectant manufac turer Microcide AF from Schülke Mayr liquid or cloths FD 322 from Dürr CaviCide from Metrex Tools required Cloths for wiping down the medical device Preparation methods according to ISO 17664 46 ...

Page 49: ... instructions for use for the disinfectant 6 3 2 Disinfection Manual disinfection internal The efficacy of manual internal disinfection must be demonstrated by the manufacturer of the disinfection agent With KaVo products use only dis infection agents that have been released by KaVo with respect to the com patibility of materials e g WL cid made by ALPRO Preparation methods according to ISO 17664 ...

Page 50: ...ents at a pH of max 10 e g Miele G 7781 G 7881 validation was performed with the VARIO TD programme neodisher mediclean cleaning agent neodisher Z neu tralisation agent and neodisher mielclear rinsing agent and extends only to the compatibility of materials with respect to KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use ...

Page 51: ... then lubricate immediately with care agents from the KaVo care system 6 4 Drying Manual drying Blow off the outside and inside with compressed air until water drops are no longer visible Machine drying The drying procedure is normally part of the disinfection program of the thermodisinfector Preparation methods according to ISO 17664 49 ...

Page 52: ...or com pressed air quality see the Warning under Start up 6 5 Care products and systems Servicing CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Perform proper care regularly Preparation methods according to ISO 17664 50 ...

Page 53: ...ose listed as accessories as they were tested for proper use on our products Note If you are bothered by some oil leaking during the treatment the technical set up allows for switching from servicing with oil prior to sterilisation to once weekly servicing Preparation methods according to ISO 17664 51 ...

Page 54: ...tems Servicing Torque wrench care CAUTION Malfunctions from cleaning in the ultrasonic unit Defects in the torque wrench Do not place the torque wrench in ultrasonic cleaning devices Preparation methods according to ISO 17664 52 ...

Page 55: ... is pressed into the tor que wrench in the slots or grease pockets of the locking springs Then place a small amount of grease on your fingertip and press it into the torque wrench at the indicated location see arrow Then rotate the torque wrench and regrease if necessary Preparation methods according to ISO 17664 53 ...

Page 56: ...Care with KAVOspray KaVo recommends servicing the product once per week Remove tip Cover the product with the Cleanpac bag Place the product on the cannula and press the spray button for one second Preparation methods according to ISO 17664 54 ...

Page 57: ...o recommends servicing the product once per week Remove tip Place 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 55 ...

Page 58: ...s Servicing Care with KaVo QUAT TROcare Cleaning and care unit with expansion pressure for effective cleaning and care KaVo recommends servicing the product once per week Remove the tip Preparation methods according to ISO 17664 56 ...

Page 59: ...strument so that the bag is not stretched The quality and use of the sterilised product packaging must satisfy ap plicable 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 57 ...

Page 60: ...TERIclave B 2200 2200 P CAUTION Premature weary and malfunctions from improper servicing and care Reduced product life Before each sterilisation cycle service the medical device with KaVo care products However if over oiled the SONICflex will differ from the guidelines Preparation methods according to ISO 17664 58 ...

Page 61: ...tely remove the product from the steam steriliser after the sterilisation cycle Note Remove the tips to be sterilized and dry the medical device The KaVo medical device has a maximum temperature resistance up to 138 280 4 F Preparation methods according to ISO 17664 59 ...

Page 62: ...es at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Autoclave using the gravitation method at least 10 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F or alternatively at least 60 minutes at 121 C 1 C 4 C 250 F 1 6 F 7 4 F 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 60 ...

Page 63: ...Note Observe the expiration date of the sterilised item Preparation methods according to ISO 17664 61 ...

Page 64: ... Mat no Instrument stand 2151 0 411 9501 Cellulose pad 100 units 0 411 9862 Cleanpac 10 units 0 411 9691 Torque wrench 1 000 4887 Coupling 1 006 5966 Open ended wrench 0 411 0892 Silicone grease 1 000 6403 Nozzle needle 0 410 0911 Insert for SONICflex 0 411 9902 Tools 62 ...

Page 65: ...plus Spray 2140 P 1 005 4525 No Tip type Mat no 5 Universal scaler Mat no 0 571 5171 6 Crescent scaler Mat no 0 571 5181 7 Perio scaler Mat no 0 571 5191 8 Perio extra long scaler Mat no 0 571 5371 12 Cem Mat no 0 571 5431 Cem attachment Mat no 0 571 7142 16 Retro cylinder left Mat no 0 571 5541 17 Retro cylinder right Mat no 0 571 5581 Tools 63 ...

Page 66: ...Mat no 0 571 5621 25 Root planer button small right Mat no 0 571 5631 26 Root planer button small uni versal Mat no 0 571 5641 27 Rootplaner button large perio Mat no 0 571 5651 28 Micro torpedo shape mesial Mat no 0 571 6741 29 Micro torpedo shape distal Mat no 0 571 6731 30 Micro small hemispherical me sial Mat no 0 571 6811 Tools 64 ...

Page 67: ... mesial Mat no 1 002 1984 35 Prep CAD CAM distal Mat no 1 002 1986 42 Cariex D 0 8 D 64 Mat no 1 000 7105 43 Cariex D 1 2 D 64 Mat no 1 000 7167 45 Seal conical D 46 Mat no 1 000 2568 48 Clean brush holder Mat no 0 571 0401 Clean brush no 1 Refill Mat no 1 004 4125 Clean brush no 2 Refill Mat no 1 004 4126 Clean brush no 3 Refill Mat no 1 004 4127 Clean brush no 4 Refill Mat no 1 004 4128 Tools 65...

Page 68: ...sial Mat no 0 571 7262 52 Prep ceram distal Mat no 0 571 7272 53 Angle distal Mat no 0 571 7302 54 Angle mesial Mat no 0 571 7292 55 Retro anterior tooth Mat no 0 571 7342 56 Retro finder left Mat no 0 571 7322 57 Retro finder right Mat no 0 571 7332 Retro plug left Mat no 0 571 5601 Retro plug right Mat no 0 571 5611 58 Bevel mesial Mat no 0 571 7392 59 Bevel distal Mat no 0 571 7382 Tools 66 ...

Page 69: ... Mat no 1 000 5822 68 Endo conical 112 Mat no 1 000 5823 69 Endo button small 117 Mat no 1 000 5827 70 Endo conical 117 Mat no 1 000 5821 71 Cariex TC 1 0 Mat no 1 000 7362 72 Cariex TC 1 4 Mat no 1 000 7363 80 Bone rectangular cutting Mat no 1 004 3875 81 Bone sphere large D 46 Mat no 1 004 3876 82 Bone sphere large Mat no 1 004 3877 83 Bone saw sagittal Mat no 1 004 3878 Tools 67 ...

Page 70: ...aler Mat no 1 006 0741 87 Bone saw blade Mat no 1 006 1275 Bone saw blade refill Mat no 1 006 1405 Implant Set Mat no 1 003 8167 Implant Pin Refill Mat no 1 003 8168 Swing Set Mat no 1 006 2045 Swing 015 Refill Mat no 1 006 2042 Swing 020 Refill Mat no 1 006 2043 Swing 025 Refill Mat no 1 006 2044 Tools 68 ...

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