Related Manuals for KaVo SONICflex 2003
Summary of Contents for KaVo SONICflex 2003
- Page 1 Instructions for use SONICflex 2003 - REF 1.000.4246 SONICflex LUX 2003 L - REF 1.000.4243...
- Page 2 Distributed by: Manufacturer: KaVo Dental GmbH Kaltenbach & Voigt GmbH Bismarckring 39 Bismarckring 39 D-88400 Biberach D-88400 Biberach Tel. +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...
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Page 3: Table Of Contents
Contents Contents 1 User instructions ............................... 5 1.1 Warranty terms and conditions ......................... 7 2 Safety ................................9 2.1 Description of safety instructions ......................9 2.1.1 Description 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 .......... - Page 4 Contents 3.2 Transport and storage conditions ......................22 4 First use ................................24 4.1 Connecting to devices ..........................26 4.2 Attaching the MULTIflex and MULTIflex LUX coupling ................27 4.3 Check O-rings ............................27 4.4 Check the pressure ..........................28 5 Operation ................................
- Page 5 Contents 6 Preparation methods according to ISO 17664 ....................38 6.1 Preparations at the site of use ........................ 38 6.2 Cleaning ..............................39 6.2.1 Cleaning: Manual cleaning - external ..................40 6.2.2 Cleaning: Automated external cleaning ..................41 6.2.3 Cleaning: Manual cleaning - internal ..................42 6.2.4 Cleaning: Automated internal cleaning ..................
- Page 6 6.5.2 Care products and systems - Servicing: 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 .............................
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Page 7: User Instructions
User instructions 1 User instructions 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 Symbols Refer to Safety/Warning symbol chapter... - Page 8 User instructions Action request CE mark (Communauté Européenne). 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 Target group This document is intended for dentists and their assistants.
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Page 9: Warranty Terms And Conditions
12 months from date 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. - Page 10 User instructions 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. 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.
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Page 11: Safety
Safety 2 Safety 2.1.1 Description of safety instructions: Warning symbol Warning 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. -
Page 12: Description Of Safety Instructions: Description Of Danger Levels
Safety 2.1.3 Description of safety instructions: Description of danger levels The safety 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. -
Page 13: Purpose - Proper Use
▪ 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‐... - Page 14 Safety 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, the user is required to: ▪...
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Page 15: Safety Instructions
Safety 2.3 Safety instructions WARNING Hazard to the care provider and 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. - Page 16 Safety CAUTION Injury or damage due to wear. Irregular operating noise, excessive or very low vibrations, or if the instru‐ ment tip becomes loose. ▶ Stop work and seek service support. CAUTION Premature wear and malfunctioning from improper storage during long periods of nonuse.
- Page 17 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.
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Page 18: Safety Instructions: Sonicflex Tips
Safety Service may only be carried out by KaVo-trained repair shops using original KaVo replacement parts. 2.3.1 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. - Page 19 Safety Note Regularly check the wear of the tip with the tip test card (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.
- Page 20 Safety ▶ For an additional safety check, mechanically apply approx. 10 N (1 kg) to the tip without operating the device.
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Page 21: Product Description
Product description 3 Product description SONICflex 2003, (Mat. no. 1.000.4246) SONICflex LUX 2003 L (Mat. no. 1.000.4243) -
Page 22: Technical Data
The SONICflex is a dental handpiece that complies with ISO 15606. The vibration is generated by a rotating steel sleeve. In connection with the dif‐ ferent KaVo tips, an oscillating elliptical tip movement is generated for the respective application. The internal water cooling (spray cooling) prevents the treatment field from heating up, and keeps the treatment surface clean. - Page 23 Product description 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 couplings. ▪ Oscillation level 1 = 120 +/- 15 μm ▪ Oscillation level 2 = 160 +/- 15 μm ▪...
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Page 24: Transport And Storage Conditions
Product description 3.2 Transport 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 temperature of 20°C to 25°C (68°F to 77°F). - Page 25 Product description Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture.
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Page 26: First Use
Infection danger to the care provider and patient. ▶ Before first use and after each use, sterilise the medical device. The SONICflex can be used in conjunction with KaVo tips for plaque re‐ moval, prophylaxis, endodontics, periodontology, surgery and conservative dentistry. - Page 27 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...
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Page 28: Connecting To Devices
First use 4.1 Connecting to devices CAUTION Damage 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. -
Page 29: Attaching The Multiflex And Multiflex Lux Coupling
First use 4.2 Attaching the MULTIflex and MULTIflex LUX coupling ▶ Screw 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. -
Page 30: Check The Pressure
First use Number of available O-rings: 5 4.4 Check the pressure A minimum drive pressure of 2.5 bar (36 psi) is required for operating the SONICflex. A higher drive pressure will be reduced automatically inside the SONICflex. The air consumption is approximately 20-40 NI/min. Insert the test manometer (Mat. - Page 31 First use...
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Page 32: Operation
Operation 5 Operation 5.1 Attaching SONICflex CAUTION Ensure that the 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. - Page 33 Operation CAUTION Imprecise coupling especially during the afterglow period. Imprecise 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.
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Page 34: Removing Sonicflex
Operation 5.2 Removing SONICflex ▶ Hold the MULTIflex / MULTIflex LUX coupling tightly, and pull the SONICflex forward while twisting slightly. -
Page 35: Inserting Sonicflex Tip
▶ 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. - Page 36 Operation ▶ Insert the desired tip with the tip end pointing down into the torque wrench and screw it into the handpiece by turning 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 ①.
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Page 37: Removing Sonicflex Tip
Operation Note When the SONICflex 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. -
Page 38: Power Setting
Operation 5.5 Power setting Use the control ring of the SONICflex to set performance levels 1, 2, and 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. -
Page 39: Check The Amount Of Water
Operation and anticlockwise to increase 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 /min! -
Page 40: Preparation Methods According To Iso 17664
Preparation methods according to ISO 17664 6 Preparation methods according to ISO 17664 Note The following preparation procedure applies for the SONICflex instrument, 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. -
Page 41: Cleaning
Preparation methods according to ISO 17664 ▶ The medical device must be dry when transporting it to the site of re‐ processing. ▶ Do not place it in a solution or the like. ▶ Reprocess the medical device as soon as possible after treatment. ▶... -
Page 42: Cleaning: Manual Cleaning - External
Preparation methods according to ISO 17664 6.2.1 Cleaning: Manual cleaning - external Accessories required: ▪ 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. -
Page 43: Cleaning: Automated External Cleaning
"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 of the thermodisinfector (com‐... -
Page 44: Cleaning: Manual Cleaning - Internal
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. - Page 45 Preparation methods according to ISO 17664 Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the following countries: Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxem‐ bourg, Belgium, Netherlands, United Kingdom, Denmark, Sweden, Fin‐ land and Norway.
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Page 46: Cleaning: Automated Internal Cleaning
"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 of the thermodisinfector (com‐... -
Page 47: Disinfection
Preparation methods according to ISO 17664 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. -
Page 48: Disinfection: Manual Disinfection - External
Preparation methods according to ISO 17664 6.3.1 Disinfection: Manual disinfection - external KaVo recommends the following products based on material compatibility. The microbiological efficacy must be ensured by the disinfectant manufac‐ turer. ▪ Microcide AF from Schülke&Mayr (liquid or cloths) ▪... -
Page 49: 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). -
Page 50: Disinfection: Machine Disinfection - External And Internal
Preparation methods according to ISO 17664 ▶ Immediately after internal disinfection, lubricate the KaVo medical de‐ vice immediately with care agents from the KaVo care system. 6.3.3 Disinfection: Machine disinfection - external and internal KaVo recommends thermodisinfectors in accordance with EN ISO 15883 that are operated with alkaline cleaning agents at a pH of max. -
Page 51: Drying
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. 6.4 Drying Manual drying ▶... -
Page 52: Care Products And Systems - Servicing
Preparation methods according to ISO 17664 Note Please follow the instructions for use of the thermodisinfector (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. - Page 53 Preparation methods according to ISO 17664 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. 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.
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Page 54: Care Products And Systems - Servicing: Torque Wrench Care
Preparation methods according to ISO 17664 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. - Page 55 Preparation methods according to ISO 17664 If the torque wrench runs roughly, it should be lubricated with silicone grease (Mat. no. 1.000.6403). The silicone grease 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).
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Page 56: Care Products And Systems - Servicing: Care With Kavospray
Preparation methods according to ISO 17664 6.5.2 Care products and systems - Servicing: 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... -
Page 57: Care Products And Systems - Servicing: Care Of The Kavo Sprayrotor
Preparation methods according to ISO 17664 6.5.3 Care products and systems - Servicing: Care of the KaVo SPRAYr‐ otor KaVo 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. -
Page 58: Care Products And Systems - Servicing: Care With Kavo Quattrocare
Preparation methods according to ISO 17664 6.5.4 Care products and systems - 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. -
Page 59: Packaging
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)! -
Page 60: Sterilisation
ISO 17665-1 (e.g. KaVo STERIclave 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. - Page 61 ▶ Immediately 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).
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Page 62: Storage
Preparation methods according to ISO 17664 (Depending on the available autoclave,) select a suitable procedure from the following sterilisation processes: ▪ Autoclave with three times initial vacuum: – at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) ▪... - Page 63 Preparation methods according to ISO 17664 Note Observe the expiration date of the sterilised item.
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Page 64: Tools
Tools 7 Tools Obtainable from dental and medical suppliers Material summary 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... - Page 65 Tools 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 2140 P 1.005.4525 Tip type Mat. no, Universal scaler Mat. no. 0.571.5171 Crescent scaler Mat. no. 0.571.5181 Perio scaler Mat.
- Page 66 Tools Tip type Mat. no, Retro T-shape left Mat. no. 0.571.5521 Retro T-shape Mat. no. 0.571.5561 Undercut Root planer, button, small left Mat. no. 0.571.5621 Root planer, button, small right Mat. no. 0.571.5631 Root planer, button, small uni‐ Mat. no. 0.571.5641 versal Rootplaner, button, large perio Mat.
- Page 67 Tools Tip type Mat. no, Micro small, hemispherical dis‐ Mat. no. 0.571.6801 Micro large, hemispherical me‐ Mat. no. 0.571.6831 sial Micro large, hemispherical distal Mat. no. 0.571.6821 Prep CAD-CAM mesial Mat. no. 1.002.1984 Prep CAD-CAM distal Mat. no. 1.002.1986 Cariex D 0.8, D 64 Mat.
- Page 68 Tools Tip type Mat. no, Clean brush no. 5 Refill Mat. no. 1.004.4129 Clean brush no. 6 Refill Mat. no. 1.004.4130 Prep gold mesial Mat. no. 0.571.7212 Prep gold distal Mat. no. 0.571.7222 Prep ceram mesial Mat. no. 0.571.7262 Prep ceram distal Mat.
- Page 69 Tools Tip type Mat. no, Perio straight Mat. no. 0.571.7402 Period left Mat. no. 0.571.7412 Perio right Mat. no. 0.571.7422 Endo button large 117° Mat. no. 1.000.5825 Endo conical 125° Mat. no. 1.000.5822 Endo conical 112° Mat. no. 1.000.5823 Endo button small 117° Mat.
- Page 70 Tools Tip type Mat. no, Bone saw axial Mat. no. 1.004.3879 Bone elephant foot Mat. no. 1.006.0645 Bone scaler Mat. no. 1.006.0741 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.
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