Turbine Instructions for Use

Contents Symbols... 4

in the Instructions for use...4 on the medical device / packaging...5 1. Introduction... 6 2. Safety notes... 9 3. Product description... 11 RC-90 BC/RM, RC-95 BC/RM, RC-98 BC/RM ... 11 4. Operation... 12 Assembly/Removal...12 To change rotary instruments... 14 Test run... 16 5. Hygiene and maintenance... 17 General notes...17 Limitations on processing...19 Initial treatment at the point of use... 20 Manual cleaning...21 2

Automated cleaning and lubrication...23 Manual disinfection... 24 Drying... 25 Inspection, Maintenance and Testing... 26 Packaging... 30 Sterilization... 31 Storage... 33 6. Servicing... 34 7. Maintenance... 35 To change the rotor ... 35 Removal/assembly of the water filter... 36 Cleaning of the water filter... 37 8. W&H Accessories and spare parts... 38 9. Technical data... 40 10. Disposal... 43 Authorized W&H Servicepartner... 44 Explanation of warranty terms... 45 3

Symbols

WARNING! (risk of injury)

in the Instructions for use

ATTENTION! (to prevent damage occurring)

General explanations, without risk to persons or objects

Do not dispose of with domestic waste

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Symbols XXXX

on the medical device / packaging

CE marking with identification number of the Notified Body

DataMatrix Code for product information including UDI (Unique Device Identification)

Catalogue number

UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements

Serial number

Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and who intends to use or order the use of this medical device.

Date of manufacture

Data structure in accordance with Health Industry Bar Code

Sterilizable up to the stated temperature 5

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. These explain how to use your medical device and guarantee a smooth and efficient operation. Observe the safety notes. Intended use The dental turbine is intended for the following applications: Removal of decayed materials, cavities and crown cement, removal of fillings, finishing of tooth and restoration surfaces. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. 6

Qualifications of the user We have based our development and design of the medical device on the dentists, dental hygienists, dental employees (prophylaxis) and dental assistants target group. Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. 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. >> Only the components approved by the manufacturer may be replaced (rotor). >> If it proves impossible to correct the malfunction, please contact an authorized W&H service partner. 7

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 for infection control, personal safety and patient safety. Improper use, (e.g., through poor hygiene and maintenance), non-compliance with our instructions or the use of accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any other claims.

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2. Safety notes

General

>> Before using the medical device for the first time, store it at room temperature for 24 hours. >> 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). >> Use only the supply hoses as specified by EN ISO 9168 >> 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 medical device must be stopped immediately. >> Use only the filtered, oil-free and cooled air supplied by dental compressors for drive air >> Check the medical device for damage and loose parts before each use (e.g. push-button). >> Do not operate the medical device if it is damaged. >> Perform a test run before each use.

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Safety notes

General

>> Avoid overheating at the treatment site. >> 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! (RC-95, RC-98). >> Run the rinse function for the dental unit once per day. 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 medical device. 10

3. Product description

RC-90 BC/RM, RC-95 BC/RM, RC-98 BC/RM

 Nozzle cleaner  Bur changer  Spray nozzles  Seal  Drive air  Exhaust air u Spray air i Coolant o Back cap (RC-90)

push-button (RC-95, RC-98)

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4. Operation

Assembly/Removal Do not assemble or remove the medical device during operation!

 Insert the medical product with BC/RM connection into the apertures of the supply hose.

 Screw the union nut on.

 Verify full engagement.

Check the leak tightness.

 Unscrew on the union nut. Remove the turbine handpiece from the supply hose.

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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. >> Do not interfere with the running or slowing down of the rotary instrument. >> Do not activate the medical device without a rotary instrument in place, or if the bur changer is still attached.(RC-90) >> Do not activate the push-button of the medical device during operation or slowing down. This leads to detachment of the rotary instrument resp. heating of the push-button (risk of injury).(RC-95, RC-98) >> Only use rotary instruments up to the maximum operating speed stipulated by the manufacturer.

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To change rotary instruments RC-90 BC/RM  Insert the rotary instrument. w Pull out the button and push the bur changer onto the turbine heade. r Release the button and turn until the rotary instrument is clamped tightly t. y Pull out the button and remove the bur changer from the turbine head. u Verify full engagement. i To remove the rotary instrument turn it counterclockwise (max. 1/4 turn) o. 14

To change rotary instruments RC-95 BC/RM, RC-98 BC/RM  Insert the rotary instrument. Activate push-button, at the same time insert the rotary instrument until back stop. w Verify full engagement. e Remove the rotary instrument by pushing the push-button.

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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.

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5. Hygiene and maintenance

General notes

>> Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. >> Wear protective clothing, safety glasses, face mask and gloves. >> Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying.

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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. >> It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant. >> Use disinfectants which have been tested and found effective, for example by: the Verbund für Angewandte Hygiene e.V (VAH = Association for Applied Hygiene), the Österreichischen Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin (ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the Food and Drug Administration (FDA) or the U.S. Environmental Protection Agency (EPA). The user is responsible for validating its process if the specified cleaning agents and disinfectants are not available. 18

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. >> Decommission worn or damaged medical devices and/or medical devices with material changes.Send those to an authorized W&H service partner. Processing cycles >> Safe use is guaranteed until at least 1,000 reprocessing cycles. For this W&H medical device we recommend to change the rotor after 1,000 recprocessing cycles or after one year.

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Hygiene and maintenance

Initial treatment at the point of use

Clean and disinfect the medical device immediately after every treatment, to flush out liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. >> Operate the medical device for at least 10 seconds at idle speed. >> Ensure that all outlets are rinsed out. >> Wipe the entire surface of the instrument with disinfectant. >> Remove the rotary instrument. >> Remove the medical device. Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfectant step after cleaning.

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