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KaVo SONICflex quick 2008 Instructions For Use Manual Download Page 54

6.6   Packaging

Note
The sterilisation bag must be large enough for the handpiece so 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 in the sterilised item packaging.

 

 

Preparation methods according to ISO 17664

52

Summary of Contents for SONICflex quick 2008

Page 1: ...Instructions for use SONICflex quick 2008 REF 1 005 9311 SONICflex quick 2008 L REF 1 005 9310 ...

Page 2: ...Distributed by KaVo Dental Corporation 11729 Fruehauf Drive Charlotte NC 28273 USA Tel 847 550 6800 Fax 847 550 6825 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com ...

Page 3: ...symbol 7 2 1 2 Description of safety instructions Structure 7 2 1 3 Description of safety instructions Description of danger levels 8 2 2 Safety instructions 9 2 2 1 Safety instructions SONICflex tips 12 3 Product description 15 3 1 Purpose Intended use 17 3 2 Technical data 19 3 3 Transportation and storage conditions 20 Contents 1 ...

Page 4: ...s 25 4 3 Mounting the MULTIflex LUX MULTIflex LED coupling 25 4 4 Check O rings 26 4 5 Check pressures 27 5 Operation 28 5 1 Attaching SONICflex 28 5 2 Removing SONICflex 30 5 3 Inserting SONICflex tip 31 5 4 Removing SONICflex tip 33 5 5 Power setting 34 5 6 Regulating spray 34 Contents 2 ...

Page 5: ...aning Manual cleaning of the inside 39 6 2 4 Cleaning Automated internal cleaning 40 6 3 Disinfection 41 6 3 1 Disinfection Manual disinfection external 42 6 3 2 Disinfection Manual disinfection internal 43 6 3 3 Disinfection Machine disinfection external and internal 43 6 4 Drying 45 6 5 Care products and systems Servicing 46 6 5 1 Care products and systems Servicing Torque wrench care 47 Content...

Page 6: ...oducts and systems Servicing Servicing with KaVo QUATTROcare 2104 2104A 49 6 5 4 Care products and systems Servicing Servicing with KaVo QUATTROcare PLUS 51 6 6 Packaging 52 6 7 Sterilisation 53 6 8 Storage 56 7 Tools and consumables 57 8 Terms and conditions of warranty 65 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 Important information for users and service technicians User instructions 5 ...

Page 8: ...equirements 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: ...ing symbol 2 1 2 Description of safety instructions 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 measures for hazard preven tion Safety 7 ...

Page 10: ...ted 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 lead to death or fatal injury Safety 8 ...

Page 11: ...y cause death or fatal injury 2 2 Safety instructions WARNING Hazard to the care provider and patient In case of damage irregular noise during operation excessive vibration atypical heating or when the tip cannot be firmly held Stop working and contact service support Safety 9 ...

Page 12: ...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 non use Note When the SONICflex is in the holder the torque wrench should be placed on the tip to protect against injury Safety 10 ...

Page 13: ... 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 depends on the frequency of use and should be adjusted accordingly Service may only be carried out by KaVo train...

Page 14: ... 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 12 ...

Page 15: ...Note Regularly check the wear of the tip with the tip test card Mat no 1 001 6958 Safety 13 ...

Page 16: ...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 For an additional safety check mechanically apply approx 10 N 1 kg to the tip without operating the device Safety 14 ...

Page 17: ...3 Product description SONICflex quick 2008 Mat no 1 005 9311 SONICflex quick 2008 L Mat no 1 005 9310 Product description 15 ...

Page 18: ...elliptical tip motion is generated for the respective application The internal water cooling spray cooling pre vents the treatment field from heating up and keeps the treatment sur face clean Note The device should be operated with the described operating pressure After starting the intensity can be regulated using the foot switch at maximum drive pressure Product description 16 ...

Page 19: ...e or altera tion 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 Product description 17 ...

Page 20: ...h 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 Product description 18 ...

Page 21: ... 20 40 NL min Water use 30 50 ml min Frequency 6 6 5 kHz Recommended pressure 0 1 2 N The SONICflex can be mounted on all MULTIflex LUX MULTIflex LED couplings Oscillation level 1 120 15 μm Oscillation level 2 160 15 μm Oscillation level 3 240 15 μm Product description 19 ...

Page 22: ...ended settings must be observed 3 3 Transportation and storage conditions CAUTION It is hazardous to start up the medical device 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 tempera ture of 20 C to 25 C 68 F to 77 F Product description 20 ...

Page 23: ...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 21 ...

Page 24: ...re 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 must be appropriately prepared or steri lised if this is necessary Start up and shut down 22 ...

Page 25: ...the SONIC flex is gentle fast and easy to use Using the neighbouring tooth for sup port makes the technique easier and and offers easier guidance The in strument must be guided back and forth easily gently and quickly The instrument is placed on the side of the tooth and guided parallel to the tooth The instrument should be moved parallel to the surface of the tooth and not the edge to prevent for...

Page 26: ...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 Start up and shut down 24 ...

Page 27: ...oling air can cause malfunctions Make sure that the supply of cooling air is dry clean and unconta minated according to ISO 7494 2 4 3 Mounting the MULTIflex LUX MULTIflex LED coupling Screw the MULTIflex LUX MULTIflex LED coupling onto the tur bine hose and tighten with the wrench Start up and shut down 25 ...

Page 28: ... 4 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 Number of available O rings 5 Start up and shut down 26 ...

Page 29: ...lex The air consumption is approximately 20 to 40 NI min Insert test gauge Mat no 0 411 8731 between the MULTIflex LUX MULTIflex LED 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 Start up and shut down 27 ...

Page 30: ... SONICflex is tightly seated on the coupling If the SONICflex unintentionally comes off the coupling during treat ment 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 28 ...

Page 31: ...pling can destroy the high pressure lamp of a MULTIflex LUX MULTIflex LED coupling or reduce its service life Make sure that the coupling is accurate Place the SONICflex properly on the MULTIflex LUX MULTIflex LED coupling and push it to the rear until it locks audibly Operation 29 ...

Page 32: ...5 2 Removing SONICflex Holding the MULTIflex LUX MULTIflex LED coupling pull the SONICflex forward while twisting slightly Operation 30 ...

Page 33: ... 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 31 ...

Page 34: ...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 32 ...

Page 35: ...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 33 ...

Page 36: ...ulating spray Rotate the spray ring on the MULTIflex LUX MULTIflex LED cou pling in order to regulate the fraction of water The water volume can be regulated by selecting different stop positions Turn clockwise to reduce the water volume Turn counterclockwise to increase the water volume Operation 34 ...

Page 37: ...nt torque wrench and nozzle needle 6 1 Preparations at the site of use WARNING Hazard from nonsterile products There is a risk of infection from contaminated medical devices Take suitable personal protective measures Remove all residual cement composite or blood without delay Preparation methods according to ISO 17664 35 ...

Page 38: ...orted for reconditioning Do not place it in a solution or similar Remove the tip from the SONICflex using the torque wrench 6 2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit Defects in the product Only clean manually or in a thermodisinfector Preparation methods according to ISO 17664 36 ...

Page 39: ...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 37 ...

Page 40: ...arried out with pro gramme VARIO TD cleaning agent neodisher mediclean neutralisa tion agent neodisher Z and rinsing agent neodisher mielclear and only applies 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 complying with max pH value of 10 Preparation methods ...

Page 41: ...ediately with care agents from the KaVo care system 6 2 3 Cleaning Manual cleaning of the inside Not applicable This product is suitable for automated cleaning only 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 39 ...

Page 42: ...arried out with pro gramme VARIO TD cleaning agent neodisher mediclean neutralisa tion agent neodisher Z and rinsing agent neodisher mielclear and only applies 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 complying with max pH value of 10 Preparation methods ...

Page 43: ...cal device are dry and then lubricate immediately with care agents from the KaVo care system 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 41 ...

Page 44: ...the following products based on material compatibili ty The microbiological efficacy must be ensured by the disinfectant man ufacturer CaviCide made by Metrex Consumables required Cloths for wiping off the medical device Preparation methods according to ISO 17664 42 ...

Page 45: ...isinfection internal Not applicable This product is suitable for automated disinfection only 6 3 3 Disinfection Machine disinfection external and internal KaVo recommends thermodisinfectors in accordance with ISO 15883 1 which are operated with alkaline cleaning agents with a pH value of max 10 e g Miele G 7781 G 7881 Validation was carried out with pro gramme VARIO TD cleaning agent neodisher med...

Page 46: ...sinfectants to be used please refer to the Instructions for Use of the thermodisinfector complying 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 device are dry and then lubricate immediately with care agents from the KaVo care system Preparation methods according to ISO 17664 44 ...

Page 47: ...ompressed air until water drops are no longer visible Automatic Drying The drying procedure is normally part of the disinfection program of the thermodisinfector Follow the instructions for use of the thermodisinfector Preparation methods according to ISO 17664 45 ...

Page 48: ... servicing and care 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 Preparation methods according to ISO 17664 46 ...

Page 49: ...vicing with oil prior to sterilisation to once weekly servicing 6 5 1 Care products and systems 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 47 ...

Page 50: ... 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 tor que wrench at the indicated location see arrow Then rotate the torque wrench and regrease if necessary Preparation methods according to ISO 17664 48 ...

Page 51: ...tip Cover the product with the Cleanpac bag Plug the product onto the cannula and press the spray button for one second 6 5 3 Care products and systems Servicing Servicing with KaVo QUATTROcare 2104 2104A Cleaning and care unit with expansion pressure for effective cleaning and care Preparation methods according to ISO 17664 49 ...

Page 52: ...KaVo recommends servicing the product once per week Remove the tip Servicing the product See also Instructions for use KaVo QUATTROcare 2104 2104A Preparation methods according to ISO 17664 50 ...

Page 53: ...g Servicing with KaVo QUATTROcare PLUS KaVo recommends servicing the product once per week Remove tip Servicing the product in QUATTROcare PLUS See also Instructions for use KaVo QUATTROcare PLUS Preparation methods according to ISO 17664 51 ...

Page 54: ...so 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 in the sterilised item packaging Preparation methods according to ISO 17664 52 ...

Page 55: ...1 CAUTION Premature weary and malfunctions from improper servicing and care Reduced product life Before each sterilisation cycle service the medical device with Ka Vo care products However if over oiled the SONICflex will differ from the guidelines Preparation methods according to ISO 17664 53 ...

Page 56: ...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 54 ...

Page 57: ...t 134 C 1 C 4 C 273 F 1 6 F 7 4 F Drying time 20 min Autoclave using the gravity method at least 10 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F or alternatively Drying time 30 min at least 60 minutes at 121 C 1 C 4 C 250 F 1 6 F 7 4 F Drying time 30 min Use according to the manufacturer s Instructions for Use Preparation methods according to ISO 17664 55 ...

Page 58: ...eprocessed products should be stored protected from dust with minimum exposure to germs in a dry dark and cool space Comply with the expiry date of the sterilised items Preparation methods according to ISO 17664 56 ...

Page 59: ... 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 and consumables 57 ...

Page 60: ...0 571 7142 16A Retro cylinder left Mat no 1 006 2036 17A Retro cylinder right Mat no 1 006 2035 20A Retro T shape left Mat no 1 006 2037 21A Retro T Form undercut Mat no 1 006 2038 24A Root planer button small left Mat no 1 006 1957 25A Root planer button small right Mat no 1 006 1959 26A Root planer button small uni versal Mat no 1 006 1961 27A Root planer button large perio Mat no 1 006 1963 Too...

Page 61: ...mall hemispherical dis tal Mat no 1 006 1971 32A Micro large hemispherical me sial Mat no 1 006 1973 33A Micro large hemispherical dis tal Mat no 1 006 1975 34A Prep CAD CAM mesial Mat no 1 006 1977 35A Prep CAD CAM distal Mat no 1 006 1979 42A Cariex D 0 8 D 64 Mat no 1 006 1980 43A Cariex D 1 2 D 64 Mat no 1 006 1981 45A Seal conical D 46 Mat no 1 007 1503 Tools and consumables 59 ...

Page 62: ...28 Clean brush no 5 Refill Mat no 1 004 4129 Clean brush no 6 Refill Mat no 1 004 4130 49A Prep gold mesial Mat no 1 006 1983 50A Prep gold distal Mat no 1 006 1984 51A Prep ceram mesial Mat no 1 006 1985 52A Prep ceram distal Mat no 1 006 1986 55A Retro anterior tooth Mat no 1 006 2039 56A Retro finder left Mat no 1 006 2040 57A Retro finder right Mat no 1 006 2041 Retro plug left Mat no 0 571 56...

Page 63: ...t Mat no 1 006 1936 66A Endo button large 117 Mat no 1 006 1992 67A Endo conical 125 Mat no 1 006 1994 68A Endo conical 112 Mat no 1 006 1996 69A Endo button small 117 Mat no 1 006 1998 70A Endo conical 117 Mat no 1 006 2000 71A Cariex TC 1 0 Mat no 1 006 2002 72A Cariex TC 1 4 Mat no 1 006 2004 80A Bone square cutting Mat no 1 006 2006 81A Bone ball large D 46 Mat no 1 006 2008 Tools and consumab...

Page 64: ...A Bone saw blade Mat no 1 007 1626 Bone saw blade refill Mat no 1 006 1405 Implant set Mat no 1 006 2027 Implant pin refill Mat no 1 003 8168 Endo clean Set Mat no 1 007 1142 Endo clean 015 Refill Mat no 1 006 2042 Endo clean 020 Refill Mat no 1 006 2043 Endo clean 025 Refill Mat no 1 006 2044 96 A Endo clean needle holder Mat no 1 008 5164 Endo clean needle white 015 Mat no 1 006 2042 Tools and c...

Page 65: ... clean needle red 025 Mat no 1 006 2044 97 A Prep crown round Mat no 1 008 6384 98 A Prep crown plain Mat no 1 008 6386 Only for the USA Material summary Mat no KaVo Spray America 2113 A 0 411 9660 QUATTROcare plus Spray Ameri ca 2141 P 1 005 4524 Tools and consumables 63 ...

Page 66: ...Only for Canada Material summary Mat no KaVo Spray Canada 2114 A 0 411 9680 QUATTROcare plus Spray Canada 2149 P 1 005 4523 Tools and consumables 64 ...

Page 67: ...ranty 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 apply in the absence of manda tory legal regulations to the contrary KaVo shall not be liable for defects and their consequences that have arisen or may arise from natural wear improper handling cle...

Page 68: ...ourfastness 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 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 deliv ery The dealer purchase date type and ...

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