Related Manuals for W&H AlegraTE-97 LQ
Summary of Contents for W&H AlegraTE-97 LQ
- Page 1 Instructions for use Turbine handpieces with LED TE-97 LQ / TE-98 LQ Quick coupling with generator RQ-53 / RQ-54 Turbine handpieces without light TE-95 BC / TE-95 RM TE-97 / TE-97 BC / TE-97 RM TE-98 / TE-98 BC / TE-98 RM...
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Page 2: Table Of Contents
Contents Symbols....................................1. Introduction ..................................2. Safety notes ..................................3. Product description ................................Quick coupling with generator ................................14 Turbine TE-97 LQ / TE-98 LQ ................................16 Turbine TE-97 / TE-98 ..................................17 Turbine TE-95 BC / TE-97 BC / TE-98 BC............................. 18 Turbine TE-95 RM / TE-97 RM / TE-98 RM ............................ - Page 3 Manual disinfection ..................................36 Drying ........................................ 38 Inspection, Maintenance and Testing .............................. 39 Turbine packaging .....................................44 Sterilization ....................................... 45 Storage .......................................48 6. Maintenance ..................................Replacing the rotor .................................... 49 Cleaning/Replacing the water filter ..............................51 Replacing the generator ................................... 53 Replacing the O-rings ..................................55 7.
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Page 4: Symbols
Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of with (risk of injury) (to prevent without risk to domestic waste damage occurring) persons or objects on the Quick coupling Type B applied part (not suitable for intracardiac application) - Page 5 Symbols packaging /Quick coupling/turbine CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Catalogue number Thermo washer Sterilizable up to the disinfectable stated temperature Serial number...
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Page 6: Introduction
1. Introduction Customer satisfaction has absolute priority in the W&H quality policy. This medical device has been developed, manufactured and subjected to final inspection according to legal regulations, quality and industry standards. For your safety and the safety of your patients Prior to initial use please read the Instructions for use. - Page 7 Intended use The dental turbine handpiece is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces. The coupling is intended for the following applications: Connector for media transfer (air, water, electricity and light) between the supply hose and the dental unit and air driven motors.
- Page 8 Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions: > The medical device must be used in accordance with these Instructions for use. >...
- Page 9 Skilled application The medical device is intended only for skilled application according to the intended use as well as in compliance with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance with these Instructions for use. The medical device should be prepared for use and maintained by staff who have been trained in procedures forinfection control, personal safety and patient safety.
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Page 10: Safety Notes
2. Safety notes > The operation of the medical device is permitted only on supply units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). > Before using the medical device for the first time, store it at room temperature for 24 hours. >... - Page 11 > Do not use the medical device if there are soft tissue wounds in the mouth. The air pressure can cause septic substances to enter the tissue or trigger embolisms. > Do not lift the cheek or tongue with the medical device. Risk of burning due to the push-button heating up! >...
- Page 12 Risks due to electromagnetic fields TE-97 LQ, TE-98 LQ, RQ-53, RQ-54 The functionality of active implantable medical devices (AIMD) (e.g. cardiac pacemaker, ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if the patient has active implantable medical devices (AIMD) before using the medical device and inform about the risks.
- Page 13 Hygiene and maintenance prior to initial use > The medical device is sealed in PE film and not sterilized when delivered. > The PE film and the packaging are non-sterilizable. > Clean, disinfect and lubricate the medical device. > Sterilize the turbine and the nozzle cleaner.
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Page 14: Product Description
3. Product description Quick coupling with generator RQ-53 / RQ-54 O-rings Electrical contacts Gasket Water filter with resuction stop Generator Connections Drive air Water Spray air Exhaust ... - Page 15 All Quick couplings are equipped with a non-retraction valve which prevents contaminated cooling water from being sucked back into the turbine and the supply hose. The non-retraction valve is integrated in the cooling water supply system. In the event of blocked or incorrectly routed cooling water lines, please contact an authorized W&H service partner (see page 73).
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Page 16: Turbine Te-97 Lq / Te-98 Lq
Product description Turbine TE-97 LQ / TE-98 LQ Push-button Spray nozzles Light source (LED) Sheath Nozzle cleaner Roto Quick connection The turbine handpiece TE-97 LQ / TE-98 LQ may only be used with the Quick coupling RQ-53 / RQ-54. -
Page 17: Turbine Te-97 / Te-98
Product description Turbine TE-97 / TE-98 Push-button Spray nozzles Sheath Nozzle cleaner Roto Quick connection ... -
Page 18: Turbine Te-95 Bc / Te-97 Bc / Te-98 Bc
Product description Turbine TE-95 BC / TE-97 BC / TE-98 BC Push-button Spray nozzles Sheath Nozzle cleaner Gasket Water filter with resuction stop Supply hose Connections Drive air Water ... -
Page 19: Turbine Te-95 Rm / Te-97 Rm / Te-98 Rm
Product description Turbine TE-95 RM / TE-97 RM / TE-98 RM Push-button Spray nozzles Sheath Nozzle cleaner Gasket Water filter with resuction stop Supply hose Anschlüsse Drive air Water Spray air ... -
Page 20: Operation
4. Operation Assembly/Removal Quick coupling RQ-53 / RQ-54 Connect the Quick coupling to the supply hose. Firmly tighten the union nut of the supply hose by hand in a clockwise direction to ensure there are no leaks. Verify full engagement. ... - Page 21 Checking the Quick coupling for leak > Push an appropriate air driven medical device onto the Quick coupling. > Activate the medical device, or if possible just activate the spray water only. > No water should leak between the Quick coupling and the air driven medical device, and the coupling and the supply hose.
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Page 22: Assembly/Removal Turbine
Operation Assembly/Removal Turbine TE-97 LQ / TE-98 LQ / TE-97 / TE-98 Do not assemble or remove the medical device during the operation! Push the turbine handpiece onto the Quick coupling. Verify full engagement. Pull the retention sleeve of the Quick coupling ... - Page 23 > Always follow recommendations made by the manufacturer of air driven products. > Only connect air driven product with appropriate connection to the Quick coupling. > The user accepts sole responsibility if other air driven products are used. We accept no liability in such cases.
- Page 24 Operation Assembly/Removal Turbine TE-95 BC / TE-97 BC / TE-98 BC Do not assemble or remove the medical device during operation! Insert the turbine handpiece into the apertures of the supply hose. Screw the union nut on. Verify full engagement. ...
- Page 25 Operation Assembly/Removal Turbine TE-95 RM / TE-97 RM / TE-98 RM Do not assemble or remove the medical device during operation! Insert the turbine handpiece into the apertures of the supply hose. Screw the union nut on. Verify full engagement. ...
- Page 26 Rotary instruments > Use only rotary instruments which are in perfect condition. Follow the operating instructions of the manufacturer > Insert the rotary instrument only when medical device is stationary. > Never touch the rotary instrument while it is still rotating. >...
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Page 27: To Change Rotary Instrument
To change rotary instrument Insert the rotary instrument. Activate push-button, at the same time insert the rotary instrument until back stop. Verify full engagement. Remove the rotary instrument by pushing the push-button. -
Page 28: Test Run
Test run Do not hold the medical device at eye level! > Insert the rotary instrument. > Start the medical device. In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating, coolant failure or leakage) stop the medical device immediately and contact an authorized W&H service partner. -
Page 29: Hygiene And Maintenance
5. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > The information on the validated reprocessing procedures serves as an example of an ISO 17664 compliant processing of the medical device. >... - Page 30 Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. > Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic.
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Page 31: Limitations On Processing
Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner. -
Page 32: Initial Treatment At The Point Of Use
Hygiene and maintenance Initial treatment at the point of use Clean the medical device immediately after every treatment, to flush out liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. Turbine > Operate the medical device for at least 10 seconds at idle speed. >... -
Page 33: Manual Cleaning
Manual cleaning Do not place the medical device in liquid disinfectant or in an ultrasonic bath! > Clean the medical device under running tap water (<35°C / 95°F). > Rinse and brush off all internal and external surfaces. > Move moving parts back and forth several times. >... - Page 34 Cleaning of the spray nozzles > Clean coolant outlets carefully with the nozzle cleaner to remove dirt and deposits Clean and disinfect the nozzle cleaner in an ultrasonic bath / disinfection bath. Cleaning of the coolant tubes > Blow through the coolant tube using compressed air.
- Page 35 TE-97 LQ / TE-98 LQ Cleaning of the light source Avoid scratching of the light source! Wash the light source with cleaning fluid and a soft cloth. Blow the light source dry using compressed air or dry it with a soft cloth. >...
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Page 36: Manual Disinfection
Hygiene and maintenance Manual disinfection > W&H recommends wiping down with disinfectant. Evidence of the medical device’s basic suitability for effective manual disinfection was provided by an independent test laboratory using the disinfectants “mikrozid® AF wipes” (Schülke & Mayr GmbH, Norderstedt) and “CaviWipes™”... - Page 37 Hygiene and maintenance Automated cleaning and disinfection W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. Evidence of the medical device’s basic suitability for effective automated disinfection was provided by an independent test laboratory using the “Miele PG 8582 CD”...
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Page 38: Drying
Hygiene and maintenance Drying > Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. > Remove any liquid residues using compressed air. -
Page 39: Inspection, Maintenance And Testing
Hygiene and maintenance Inspection, Maintenance and Testing Inspection > Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices that are still soiled. > Sterilize the turbine following cleaning, disinfection and lubrication. - Page 40 Turbine lubrication > Lubricate the dry medical device immediately after TE-95 RM TE-95 BC cleaning and/or disinfection. TE-97 RM TE-97 BC > Direct the medical device downwards. TE-98 RM TE-98 BC Recommended lubrication cycles > Essential after every internal cleaning >...
- Page 41 Lubrication of the chucking system With W&H Service Oil F1, MD-400 > Fit the spray adaptor REF 02036100 onto the spray can. > Hold the medical device firmly. > Press the tip of the spray adaptor firmly into the chucking system >...
- Page 42 Lubrication of the generator (coupling) Recommended lubrication cycles RQ-54 > 1x a month see chapter “Maintenance” With W&H Service Oil F1, MD-400 > Follow the instructions on the oil spray can and on the packaging. RQ-53 With W&H Assistina > Follow the instructions in the Assistina Instructions for use.
- Page 43 Test after lubrication > Direct the medical device downwards. > Operate the medical device so that excess oil can escape. > Remove any oil that has escaped.
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Page 44: Turbine Packaging
Hygiene and maintenance Turbine packaging Pack the medical device and the accessories in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. >... -
Page 45: Sterilization
Hygiene and maintenance Sterilization W&H recommends sterilization according to EN 13060, EN 285 oder ANSI/AAMI ST55. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the medical device. >... - Page 46 Recommended sterilization procedures > “Dynamic-air-removal prevacuum cycle” (type B) / “Steam-flush pressure-pulse cycle” (type S)*/** 134⁰C (273⁰F) for at least 3 minutes, 132⁰C (270⁰F) for at least 4 minutes > “Gravity-displacement cycle” (type N)** 121⁰C (250⁰F) for at least 30 minutes >...
- Page 47 Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L* steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)), the Systec VE-150* steam sterilizer (Systec) and the CertoClav MultiControl MC2-S09S273** steam sterilizer (CertoClav GmbH, Traun).
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Page 48: Storage
Hygiene and maintenance Storage > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging. > The Quick coupling may be stored on the supply hose. -
Page 49: Maintenance
6. Maintenance Replacing the rotor Unscrew the push-button using the hexagon wrench. Push the rotor out of the turbine head using the tip of a pair of tweezers. Clean the inside of the turbine head and the push-button with a cloth soaked in isopropyl alcohol. - Page 50 Screw the push-button onto the turbine head. Tighten the push-button using the hexagon wrench. Check free running of the rotor. Activate the push-button and remove the mandrel. > Perform a test run. > Repeat the complete hygiene and maintenance process.
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Page 51: Cleaning/Replacing The Water Filter
Cleaning/Replacing the water filter RQ-53 / RQ-54 TE-95 BC / RM, TE-97 BC / RM, TE-98 BC / RM Remove the gasket. Pull the water filter out using a pair of tweezers. Clean the water filter Insert a new water filter ... - Page 52 Cleaning the water filter Clean outlets carefully with the nozzle cleaner to remove dirt and deposits. The water filter can be cleaned in an ultrasonic bath. > Perform a test run. > Repeat the complete hygiene and maintenance process.
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Page 53: Replacing The Generator
Replacing the generator RQ-53 / RQ-54 Remove the gasket. Pull out the old generator. ... - Page 54 Position the new generator with the mark aligned with the notch on the Quick coupling. Insert the new generator until back stop. Slide on the gasket. ...
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Page 55: Replacing The O-Rings
Replacing the O-rings RQ-53 / RQ-54 > Replace damaged or leaking O-rings immediately. > Always replace all the O-rings. > Do not use a sharp tool! Squeeze the O-ring between your thumb and index finger so that it forms a loop. Pull off the O-ring. -
Page 56: Troubleshooting
7. Troubleshooting Malfunction Correction of malfunction Insufficient power > Check the connection between the turbine handpiece /Quick coupling and supply hose > Check the operating pressure > Perform an oil service > Check/replace the O-rings > Replace the rotor Insufficient/no cooling >... - Page 57 Troubleshooting Malfunction Correction of malfunction Inadequate hold of rotary instrument > Perform an oil service > Replace the push-button > Replace the rotor Insufficient/no light > Check the operating pressure > Perform an oil service Attach another LED turbine handpiece to >...
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Page 58: Servicing
8. Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it. -
Page 59: W&H Accessories And Spare Parts
9. W&H Accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners Description RQ-53 RQ-54 Description 02015100 Nozzle cleaner 000301xx Assistina 301 plus 07508900 O-ring set (2x large, 1x small) 02685000 Base adaptor for RQ-54 / TE-95 RM / TE-97 RM / TE-98 RM 01000700 BC gasket 02690400 Adaptor for TE-97 LQ / TE-98 LQ / TE-97 / TE-98... - Page 60 W&H Accessories and spare parts Description TE-97 TE-97 LQ TE-98 TE-98 LQ 10940021 Service Oil F1, MD-400 (6 pcs) 02015100 Nozzle cleaner 02229200 Spray cap with nozzle 06641900 Push-button 07548000 Push-button 06787500 Rotor with hexagon wrench 07234100 Rotor with hexagon wrench 07508800 Torque wrench...
- Page 61 W&H Accessories and spare parts Bezeichnung TE-95 BC TE-97 BC TE-98 BC TE-95 RM TE-97 RM TE-98 RM 10940021 Service Oil F1, MD-400 (6 pcs) 02015100 Nozzle cleaner 02036100 Spray cap with nozzle 06641900 Push-button 07548000 Push-button 01000700 BC gasket 02207300 RM gasket 06787500...
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Page 62: Technical Data
10. Technical data Turbine TE-98 / TE-98 LQ TE-97 / TE-97 LQ Connection W&H Roto Quick Ø Rotary instruments ISO 1797 ( 1.6 – 0.01 Maximum length approved by W&H ** (mm) Minimum chucking length until back stop Maximum operating part diameter (mm) Maximum idle mode speed (±... - Page 63 Technical data Turbine TE-95 BC / TE-98 BC TE-97 BC Connection according to standard EN ISO 9168:2009 Type 1: Borden 2-hole Ø Rotary instruments ISO 1797 ( 1.6 – 0.01 Maximum length approved by W&H ** (mm) Minimum chucking length until back stop Maximum operating part diameter (mm)
- Page 64 Technical data Turbine TE-95 RM / TE-98 RM TE-97 RM Connection according to standard EN ISO 9168:2009 Type 3: Standard 4-hole Ø Rotary instruments ISO 1797 ( 1.6 – 0.01 Maximum length approved by W&H** (mm) Minimum chucking length until back stop Maximum operating part diameter (mm) Maximum idle mode speed (±...
- Page 65 Technical data Quick coupling RQ-53 RQ-54 Connection according to standard EN ISO 9168:2009 Type 1: Borden 2-hole Type 3: Standard 4-hole Recommended operating pressure (bar/psi) 2.2 – 2.8 bar / 32 - 40.6 psi Power and speed data are largely dependent on the quality of the turbine hoses used and may therefore differ from the specified values.
- Page 66 Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Temperature of the medical device on the patient side: maximum 50°C (122°F) Temperature of the working part (rotary instrument): maximum 41°C (105.8°F) Ambient conditions Temperature during storage and transport -40°C to +70°C (-40°F to +158°F) Humidity during storage and transport 8 % to 80 % (relative), non-condensing...
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Page 67: Information On Electromagnetic Compatibility According To Iec/En 60601-1-2
11. Information on electromagnetic compatibility according to IEC/EN 60601-1-2 Operating environment and EMC warning notes This medical device is neither life-sustaining nor coupled to the patient. It is suitable for operation both in domestic healthcare and in facilities used for medical purposes except rooms/areas, in which EMC interference of high-intensity may occur. - Page 68 RF communication equipment Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical device could result. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts.
- Page 69 Results of the electromagnetic tests Requirement Class / Test Level* Electromagnetic emissions Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011 [30 MHz – 1000 MHz] Class B Immunity to electromagnetic interference Electrostatic discharge (ESD) Contact discharge: ± 8 kV IEC/EN 61000-4-2 Air discharge: ±...
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Page 70: Disposal
12. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Accessories, consumables, spare parts > Packaging... -
Page 71: Explanation Of Warranty Terms
Explanation of warranty terms This W&H medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantee faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for use have been followed. -
Page 73: Authorized W&H Service Partner
Authorized W&H service partner Find your nearest authorized W&H service partner at http://wh.com Simply go to the menu option “Service” for full details. Or simply scan the QR code. - Page 74 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50817 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 004 / 11.07.2022 office@wh.com wh.com Subject to alterations...
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