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Summary of Contents for KaVo 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: Manufacturer: KaVo Dental Corporation Kaltenbach & Voigt GmbH 11729 Fruehauf Drive Bismarckring 39 Charlotte, NC 28273 USA D-88400 Biberach Tel.: 847 550 6800 www.kavo.com Fax: 847 550 6825...
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Page 3: Table Of Contents
Contents Contents 1 User instructions ............................... 5 2 Safety ................................7 Description of safety instructions ......................7 2.1.1 Description of safety instructions: Warning symbol ..............7 2.1.2 Description of safety instructions: Structure ................7 2.1.3 Description of safety instructions: Description of danger levels ..........8 Safety instructions .......................... - Page 4 Contents 4 Start up and shut down ..........................22 Checking the amount of water ......................24 Connecting to devices .......................... 25 Mounting the MULTIflex (LUX) / MULTIflex LED coupling ..............25 Check O-rings ............................26 Check pressures ..........................27 5 Operation ................................ 28 Attaching SONICflex ..........................
- Page 5 Contents 6 Preparation methods according to ISO 17664 ....................35 Preparations at the site of use ......................35 Cleaning ............................... 36 6.2.1 Cleaning: Manual cleaning - external ..................37 6.2.2 Cleaning: Automated external cleaning ................... 38 6.2.3 Cleaning: Manual cleaning of the inside .................. 39 6.2.4 Cleaning: Automated internal cleaning ...................
- Page 6 6.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A ............................49 6.5.4 Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS ..... 51 Packaging ............................. 52 Sterilisation ............................53 Storage ..............................56 7 Tools and consumables ..........................57...
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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 the chapter on Safety/Warning symbol... - Page 8 User instructions Action request CE 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 Target group This document is intended for dentists and their assistants.
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Page 9: 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 potential consequences of non-compliance. ▶ The optional step includes necessary measures for hazard preven‐ tion. -
Page 10: 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 11: Safety Instructions
Safety DANGER DANGER indicates a maximal hazard due to a situation that can directly 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. - Page 12 Safety 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 non‐ use. Note When the SONICflex is in the holder, the torque wrench should be placed on the tip to protect against injury.
- Page 13 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 14: Safety Instructions: Sonicflex Tips
Safety 2.2.1 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. - Page 15 Safety Note Regularly check the wear of the tip with the tip test card (Mat. no. 1.001.6958).
- Page 16 Safety The tips may break from continuous stress or damage (such as being dropped 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.
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Page 17: Product Description
Product description 3 Product description SONICflex quick 2008 (Mat. no. 1.005.9311) SONICflex quick 2008 L (Mat. no. 1.005.9310) - Page 18 The SONICflex is a dental handpiece in accordance with ISO 15606. The vibrations are generated by a rotating steel sleeve. In combination with the different KaVo tips, an oscillating elliptical tip motion is generated for the respective application. The internal water cooling (spray cooling) pre‐...
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Page 19: Purpose - Intended Use
▪ Only intended for dental treatment. Any other type of use 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‐... - Page 20 Product description Proper use: 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 ▪...
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Page 21: Technical Data
Product description 3.2 Technical data Drive pressure 2.5 – 4.2 bar (29 – 44 psi) Air consumption 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. -
Page 22: Transportation And Storage Conditions
Product description 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. 3.3 Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored strongly refrigerated. - Page 23 Product description 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...
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Page 24: Start Up And Shut Down
Start up and shut down 4 Start up and shut down WARNING Hazard from nonsterile products. Infection danger to the care 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. - Page 25 Start up and shut down The SONICflex can be used in conjunction with KaVo tips for plaque re‐ moval, prophylaxis, endodontics, periodontology, surgery and conserva‐ tive dentistry. The amount of water needs to be set on the dental unit so that the instru‐...
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Page 26: Checking The Amount Of Water
Start up and shut down 4.1 Checking 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 27: Connecting To Devices
Start up and shut down 4.2 Connecting to devices CAUTION Damage from contaminated and moist cooling air. Contaminated and moist cooling 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 ▶... -
Page 28: Check O-Rings
Start up and shut down 4.4 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... -
Page 29: Check Pressures
Start up and shut down 4.5 Check pressures A minimum drive pressure of 2.5 bar (36 psi) is required for operating the SONICflex. Any higher drive pressure will be reduced automatically in the SONICflex. The air consumption is approximately 20 to 40 NI/min. Insert test gauge (Mat. -
Page 30: 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 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. - Page 31 Operation CAUTION Inaccurate coupling especially during the afterglow period. Inaccurate coupling 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.
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Page 32: Removing Sonicflex
Operation 5.2 Removing SONICflex ▶ Holding the MULTIflex (LUX)/ MULTIflex LED coupling, pull the SONICflex forward while twisting slightly. -
Page 33: 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 34 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 35: 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 36: 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 ▶ 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. -
Page 37: 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 instru‐ ment, 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. -
Page 38: Cleaning
Preparation methods according to ISO 17664 ▶ Reprocess the medical device as soon as possible after treatment. ▶ The medical device must be dry when transported 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. -
Page 39: 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 40: Cleaning: Automated External Cleaning
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... -
Page 41: Cleaning: Manual Cleaning Of The Inside
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. 6.2.3 Cleaning: Manual cleaning of the inside Not applicable. -
Page 42: Cleaning: Automated Internal Cleaning
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... -
Page 43: Disinfection
▶ 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. 6.3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. -
Page 44: 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 compatibili‐ ty. The microbiological efficacy must be ensured by the disinfectant man‐ ufacturer. ▪ CaviCide made by Metrex Consumables required:... -
Page 45: Disinfection: Manual Disinfection - Internal
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‐... - Page 46 (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.
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Page 47: Drying
Preparation methods according to ISO 17664 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 disinfection program of the thermodisinfector. -
Page 48: Care Products And Systems - Servicing
Premature wear and malfunctions from improper 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. -
Page 49: Care Products And Systems - Servicing: Torque Wrench Care
Preparation methods according to ISO 17664 Note If you are bothered by some oil leaking during the treatment, the techni‐ cal set-up allows for switching from servicing 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. - Page 50 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 tor‐...
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Page 51: Care Products And Systems - Servicing: Servicing With Kavo Spray
Preparation methods according to ISO 17664 6.5.2 Care products and systems - Servicing: Servicing with KaVo Spray KaVo recommends servicing the product once per week. ▶ Remove tip. ▶ Cover the product with the Cleanpac bag. ▶ Plug the product onto the cannula, and press the spray button for one second. - Page 52 Preparation methods according to ISO 17664 KaVo recommends servicing the product once per week. ▶ Remove the tip. ▶ Servicing the product. See also: Instructions for use KaVo QUATTROcare 2104 / 2104A...
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Page 53: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare Plus
Preparation methods according to ISO 17664 6.5.4 Care products and systems - Servicing: 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... -
Page 54: Packaging
Preparation methods according to ISO 17664 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! ▶... -
Page 55: Sterilisation
Preparation methods according to ISO 17664 6.7 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with ISO 17665-1 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. - Page 56 ▶ 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).
- Page 57 Preparation methods according to ISO 17664 Select a suitable procedure (depending on the available autoclave) from the following sterilisation processes: ▪ Autoclave with pre-vacuum: – at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) Drying time: 20 min.
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Page 58: Storage
Preparation methods according to ISO 17664 6.8 Storage ▶ Reprocessed 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. -
Page 59: Tools And Consumables
Tools and consumables 7 Tools and consumables Available from dental 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 60 Tools and consumables Tip type Mat. no. Universal scaler Mat. no. 1.005.8949 Sickle scaler Mat. no. 1.005.8950 Perio scaler Mat. no. 1.005.8951 Perio extra long scaler Mat. no. 1.006.1953 Mat. no. 1.006.2021 Cem attachment Mat. no. 0.571.7142 Retro cylinder, left Mat.
- Page 61 Tools and consumables Tip type Mat. no. Micro Torpedo shape, mesial Mat. no. 1.006.1965 Micro Torpedo shape, distal Mat. no. 1.006.1967 Micro small, hemispherical me‐ Mat. no. 1.006.1969 sial Micro small, hemispherical dis‐ Mat. no. 1.006.1971 Micro large, hemispherical me‐ Mat.
- Page 62 Tools and consumables Tip type Mat. no. Clean (brush holder) Mat. no. 1.006.1982 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.
- Page 63 Tools and consumables Tip type Mat. no. Retro plug right Mat. no. 0.571.5611 Bevel mesial Mat. no. 1.006.1988 Bevel distal Mat. no. 1.006.1990 Paro straight Mat. no. 1.006.1934 Paro left Mat. no. 1.006.1935 Paro right Mat. no. 1.006.1936 Endo button large 117° Mat.
- Page 64 Tools and consumables Tip type Mat. no. Bone ball large Mat. no. 1.006.2010 Bone saw sagittal Mat. no. 1.006.2012 Bone saw axial Mat. no. 1.006.2014 Bone elephant foot Mat. no. 1.007.1624 Bone scaler Mat. no. 1.007.1625 Bone saw blade Mat. no. 1.007.1626 Bone saw blade refill Mat.
- Page 65 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‐ 1.005.4524 ca 2141 P...
- Page 66 Tools and consumables Only for Canada Material summary Mat. no, KaVo Spray Canada 2114 A 0.411.9680 QUATTROcare plus Spray Canada 1.005.4523 2149 P...
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Page 67: Terms And Conditions Of Warranty
24 months from the date of the invoice, subject to the following con‐ ditions: In case of justified complaints, KaVo will honour its warranty with a free replacement or repair. Other claims of any nature whatsoever, in particu‐... - Page 68 Terms and conditions of warranty or chemical or electrical factors deemed abnormal or impermissible in ac‐ cordance with KaVo's instructions for use or other manufacturer's instruc‐ tions. The warranty granted does not usually extend to lamps, light con‐ ductors made of glass and glass fibres, glassware, rubber parts, and the colourfastness of plastic parts.
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