SYNEA High Speed Handpieces TA Series Instructions for Use Rev 000 July 2007

W&H Symbols

WARNING! (Risk of injury)

ATTENTION! (To prevent damage)

General explanations, without risk to persons and objects

Thermal washer disinfectable

Sterilizable up to the stated temperature

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Contents 1. 2. 3. 4.

Introduction... 4 Before use – Safety notes... 6 Product description... 8 Operation... 10 Assembly/Removal, To change dental bur, Test run 5. Cleaning and maintenance... 12 General, Pre-cleaning, Manual Cleaning, Automated cleaning and disinfection, Oil service, Sterilization W&H Accessories...22 Technical data...24 A-dec/W&H Contacts...26 Warranty... 27 3

1. Introduction Customer satisfaction has absolute priority in the W&H quality policy. This W&H product has been developed, manufactured and subjected to final inspection according to legal regulations, quality norms and industry standards. For your safety and the safety of your patients Prior to initial use please read the Instructions for use completely; they explain how to use your W&H product and ensure proper, efficient and safe operation. Intended use The high-speed handpiece is intended for the use in general dental applications: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filling and polishing.

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Production according to EU directive This high-speed handpiece is a medical product according to the EU directive 93/42/ECC. Device labeling statement Federal law restricts this device to sale by, or on the order of a licensed healthcare practicioner. Skilled application This medical product is intended only for informed use in the medical dental field according to its purpose of use in compliance with the valid health and safety at work regulations, the valid accident prevention regulations as well as in compliance with these Instructions for Use. The high-speed handpiece should be maintained according to the manufacturer’s recommendations and in line with infection control procedures for the safety and well-being of patients. Improper use, e.g. missing cleaning maintenance, or non-compliance with our Instructions or the use of accessories and spare parts which are not released by W&H, invalidates all claims under warranty and any other claims. Service In case of service or repair contact your local retail dealer or A-dec. Service and maintenance work must only be carried out by authorized A-dec/W&H repair locations.

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2. Before use – Safety notes > Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction. In case of coolant supply failure, the turbine handpiece must be stopped immediately. > Use only non-contaminated, filtered, oil-free and dry compressed air to operate the high-speed handpiece. > Check the high-speed handpiece for damage and loose parts prior to use (e.g. push button). > Ensure that the headcap is securely tightened and that the dental bur is fully seated in head of handpiece. > Do not use the high-speed handpiece at open soft tissue wounds in the mouth (the air pressure can cause septic substances to penetrate the tissue, resp. can result in air embolism). > Avoid contact between the instrument head and soft tissue (risk of burning due to the push button heating up). > Do not use the high-speed handpiece as an inspection tool. > Do not look directly into the light eye.

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> The high-speed handpiece is not suitable for use in an atmosphere of potentially explosive mixtures of anaesthetic gases containing oxygen or nitrous oxide, where these gases may accumulate in concentration (closed space), correspomding to the standards IEC 60601-1 / UL 60601-1. > The operation of the lighted high-speed handpiece is permitted only on dental units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). The power supply unit for the dental unit must comply with the following requirements: > The compliance with the leakage currents of the application section must be guaranteed by the system assembler. > The secondary voltage supply must be non-earthed. > The secondary circuits must be protected from short-circuiting and overloading. Cleaning and maintenance prior to initial use The high-speed handpiece is in a clean condition and sealed in PE-film when delivered. Lubricate the high-speed handpiece prior to initial use. Sterilize high-speed handpiece and cleaning wire. > Oil service Page 17 > Sterilization Page 21 7

3. Product description

TA-98 LED/ TA-98 LW

TA-98

TA-97 LED/ TA-97 LW

TA-97

High-speed handpiece with/without light for Roto Quick coupling ➊ push button ➋ spray ports ➌ LED* / Glass rod optic ➍ grip profile ➎ sleeve ➏ cleaning wire *

TA-97 LED / TA-98 LED/ TA-97 LW / TA-98 LW Glass rod Optics

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Product description

TA-98 LM

TA-97 LM

High-speed handpiece with/without light for Multiflex® ➊ push button ➋ spray port ➌ glass rod optic ➍ grip profile ➎ sleeve ➏ cleaning wire

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4. Operation CLICK

Assembly and removal Do not assemble/remove during the operation! ➊ Push the high-speed handpiece onto the Roto Quick coupling respectively Multiflex®. ➋ Check the secure hold on the Roto Quick coupling. ➌ Pull the retention sleeve of the Roto Quick coupling back and remove the high-speed handpiece by pulling in an axial direction. Remove the Multiflex® coupling by pulling in axial direction.

Dental burs > Use only dental burs which are in perfect condition. Follow the manufacturer´s operating instructions. > Insert dental burs only when the high-speed handpiece is stationary. > Do not interfere with the running or slowing down of dental burs. > Do not activate the push button of the high-speed handpiece during operation or slowing down. This leads to detachment of the dental bur resp. heating of the push button (risk of injury).

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To change dental bur ➊ Press the push button while simultaneously inserting the dental bur until it reaches the back stop. ➋ Check secure retention by applying slight axial tension. ➌ Remove the dental bur by pushing the push button.

Test run > Insert dental bur. > Start the high-speed handpiece. > If you observe problems (e.g. vibrations, unusual noise, overheating, coolant supply failure or leakage), or discoloration of the LED, stop the high-speed handpiece immediately and contact your local retail dealer or A-dec. 11

5. Cleaning and maintenance > Follow your country-specific directives, standards and guidelines for cleaning, disinfection and sterilization. > You can process the high-speed handpiece manually or automatically. > Wear protective clothing. > Remove the dental bur. > Remove the high-speed handpiece from the Roto Quick coupling respectively Multiflex®* coupling. > Disinfect and clean the high-speed handpiece immediately after every treatment, to flush out any liquid (e.g. blood, saliva etc.), which may have seeped in and to prevent settling on the internal parts. > Sterilize the high-speed handpiece following manual or automated disinfection, cleaning and lubrication.

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Pre-cleaning > If heavily soiled: Clean first with disinfectant cloths.

Manual cleaning internal and external ➊ Rinse under water (< 38 °C/<100 °F) with the aid of a brush (W&H recommends demineralized water). ➋ Then remove any liquid residues (absorbent cloth, blow dry with compressed air). Do not place the high-speed handpiece in liquid disinfectant or in an ultrasonic bath. 13

Clean spray ports ➌ Clean spray ports carefully with the cleaning wire from dirt and deposits.

Clean coolant tubes ➍ Blow through the coolant tube with the air syringe. In the case of clogged up spray ports or coolant tubes contact your authorized repair center. 14

Cleaning the light eye Avoid scratching of the light eye! ➊ Wash the light eye with cleaning fluid (e.g. alcohol) and a soft brush. ➋ Blow the light eye dry with air syringe or dry it carefully with a soft cloth.

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Automated cleaning and disinfection internal and external Lubricate high-speed handpiece immediately after thermal washer disinfection. High-speed handpieces with this symbol can be cleaned and disinfected in a thermal washer disinfector. W&H recommends processing with thermal washer disinfector. Note the manufacturer’s specifications on equipment, cleaning agents and detergents.

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Daily oil service with W&H Service Oil F1, MD-400 > Follow the instructions for use of the oil spray can. Daily oil service with W&H Assistina > See instructions for use of Assistina. Recommended lubrication cycles > essential after every internal cleaning > before each sterilization or > after 30 minutes of use or at least once daily

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Weekly oil service of the chuck system with W&H Service Oil F1, MD-400 > Fit the spray cap REF 02036100 on the spray can. > Grip the high-speed handpiece firmly. > Press the tip of the spray nozzle firmly into the chuck system. > Spray for approx.1 second.

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Weekly oil service of the chuck system with W&H Assistina > Fit the adaptor REF 02693000 onto the maintenance attachment. Direct spray exit nozzle downwards. > Press the dental bur side of the high-speed handpiece onto the adaptor from below. > Start the Assistina. > Press the high-speed handpiece onto the adaptor for approx. 10 seconds. > Remove the high-speed handpiece from the adaptor. > Close the cover of the Assistina and allow it to run for the remainder of the maintenance cycle (approx. 25 seconds).

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Test run following oil service ➊ Place the high-speed handpiece with the head downward. ➋ Start the high-speed handpiece for 30 seconds to remove excessive oil. > Repeat the complete cleaning and maintenance process at any sign of dirt re-emerging. ➌ Wipe with gauze or soft cloth the high-speed handpiece. > Sterilize the high-speed handpiece.

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