Alegra Contra-angle handpieces Models WE-56 LED G, WE-66 LED G, WE-99 LED G Rev 4 Instructions for Use Oct 2018

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... 13 4. Operation... 14 Assembly/Removal...14 To change rotary instruments... 16 Test run... 17

5. Hygiene and maintenance... 18 General notes... 18 Limitations on processing... 20 Initial treatment at the point of use...21

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Manual cleaning... 22 Automated cleaning and lubrication... 25 Manual disinfection... 26 Automated cleaning and disinfection... 27 Drying... 28 Inspection, Maintenance and Testing... 29 Packaging... 33 Sterilization... 34 Storage... 36

6. Servicing... 37 7. W&H Accessories and spare parts... 38 8. Technical data... 39 9. Disposal... 41 Explanation of warranty terms... 42 Authorized W&H service partner... 43 3

Symbols

WARNING! (risk of injury)

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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

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)

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, 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

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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. Intended use The dental straight/contra-angle handpiece is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing and polishing 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. >> The medical device has no components that can be repaired by the user. >> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 43).

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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

>> 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 filtered, oil-free and cooled air supplied by dental compressors to operate the medical device. >> Check the medical device for damage and loose parts each time before using (e.g., push-button). >> Do not operate the medical device if it is damaged. >> Perform a test run each time before using. >> Avoid overheating at the treatment site. >> Do not touch the soft tissue with the head of the medical device. Risk of burning if the medical device overheats! >> 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. >> Avoid contact between LED and soft tissue (risk of burning due to the LED heating up). 9

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). The light is only available from a motor speed of 9,000 rpm. The brightness depends on the motor speed. The medical device is not approved for operation in potentially explosive atmospheres.

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Risks due to electromagnetic fields 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 product 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 medical device.

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3. Product description  Push-button  Spray nozzle  LED  Sheat  Nozzle cleaner

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4. Operation

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

 Push the medical device onto the motor.  Verify full engagement.  Remove the medical device.

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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 the medical device is stationary. >> Never touch the rotary instrument while it is still rotating. >> Do not activate the chucking system of the medical device during operation. This leads to detachment of the rotary instrument, damage to the chucking system and/or heating up of the medical device. Risk of burning! >> Do not lift the cheek or tongue with the contra-angle head. Risk of burning due to the push-button heating up!

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To change rotary instruments

 Rotary instrument shank ø 1.6 mm:

Insert rotary instrument. Activate the push-button (a) and at the same time insert the rotary instrument until it reaches the limit stop (b). Rotary instrument shank ø 2.35 mm: Activate the push-button (a) and at the same time insert the rotary instrument and turn it until it snaps into place (c).

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. >> Operate 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 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) and 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. 19

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. Processing cycles >> We recommend a regular service for the W&H medical device after 1,000 processing cycles or one year.

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