Alegra Turbine Handpieces and Quick Coupling with Generator Instructions for Use

Contents Symbols... 4 1. Introduction... 6 2. Safety notes... 10 3. Product description... 14

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... 19 4. Operation... 20 Assembly/Removal Quick coupling... 20 Assembly/Removal Turbine... 22 To change rotary instrument...27 Test run... 28 5. Hygiene and maintenance... 29 General notes... 29 Limitations on processing... 31 Initial treatment at the point of use... 32 Manual cleaning... 33 2

Manual disinfection... 36 Drying... 38 Inspection, Maintenance and Testing... 39 Turbine packaging...44 Sterilization... 45 Storage...48 6. Maintenance... 49 Replacing the rotor... 49 Cleaning/Replacing the water filter ...51 Replacing the generator ... 53 Replacing the O-rings ... 55 7. Troubleshooting... 56 8. Servicing... 58 9. W&H Accessories and spare parts... 59 10. Technical data... 62 11. Disposal... 67 Explanation of warranty terms... 68 Authorized W&H service partner... 69 3

Symbols

in the Instructions for use

WARNING! (risk of injury)

ATTENTION! (to prevent damage occurring)

General explanations, without risk to persons or objects

Do not dispose of with domestic waste

on the medical device/packaging Medical Device

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Type B applied part (not suitable for intracardiac application)

Symbols XXXX

packaging /Quick coupling/on the medical device

CE marking with identification number of the Notified Body

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

Data structure in accordance with Health Industry Bar Code

Catalogue number

Thermo washer disinfectable

Sterilizable up to the stated temperature

Serial number

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

Date of manufacture

Caution! According to Federal law restricts this device to sale by or on the order of a physician, dentist, veterinarian or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.

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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.

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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 Quick coupling is intended for the following applications: Connector for media transfer (air, water, electricity and light) between the turbine handpiece and the dental unit and air driven motors. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. 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.

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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, O-rings, generator and water filter). >> Modifications or repairs must only be undertaken by an authorised W&H service partner (see page 69). >> Correct the malfunction as described in the instruction for use. >> If it proves impossible to correct the malfunction, please contact an authorized W&H service partner. 8

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. Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the competent authority!

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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. >> 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. >> Avoid overheating at the treatment site.

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>> 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! >> Run the rinse function for the dental unit once per day. >> Do not use the medical device as a light probe. >> Do not look directly into the LED. >> The Quick coupling is a functional part of the supply hose and should therefore also be seen as an extension to it during reprocessing. It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the treatment water decontamination system, as well as its handling. If the Quick coupling is processed separately from the supply hose, you can refer to the information in the chapter “Hygiene and maintenance” as per ISO 17664 from the manufacturer of the quick coupling. TE-97 LQ, TE-98 LQ, RQ-53 and RQ-54 are not approved for operation in potentially explosive atmospheres.

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Risks due to electromagnetic fields TE-97 LQ, TE-98 LQ, RQ-53 and RQ-54 The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable cardioverter defibrillator) can be affected by electric, magnetic and electromagnetic fields. >> Find out if patient and user have implanted systems before using the medical device and consider the application. >> Weigh the risks and benefits. >> Keep the medical device away from implanted systems. >> Make appropriate emergency provisions and take immediate action on any signs of ill-health. >> Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD (implantable cardioverter defibrillator).

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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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3. Product description

Quick coupling with generator RQ-53 / RQ-54

 O-rings  Electrical contacts  Nut  Gasket  Water filter with resuction stop  Generator Connections

 Drive air  Water  Spray air  Exhaust 14

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. The cooling water lines must not be cleaned with sharp objects! (This could damage the sealing element and prevent the non-retraction valve from working.)

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Product description

Turbine TE-97 LQ / TE-98 LQ

 Push-button  Spray nozzles  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.

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Product description

Turbine TE-97 / TE-98

 Push-button  Spray nozzles  Sheath  Nozzle cleaner  Roto Quick connection

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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

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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  Exhaust 19

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.

Check the leak tightness.

or

 Unscrew the union nut.  Remove the Quick coupling from the supply hose. This method of assembly provides a connection for drive air, chip air, return air, water and electricity. 20