Endea & Endo Contra-angle handpieces 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 Endea Endo Cursor... 11 Endea NiTi, Endea...12 4. Operation... 13 Assembly / Removal... 13 Changing the root canal instrument... 15 Test run... 16 5. Hygiene and maintenance... 17 General notes...17 Limitations on processing... 19 2

Initial treatment at the point of use... 20 Manual cleaning...21 Manual disinfection... 22 Automated cleaning and disinfection... 23 Drying... 24 Inspection, Maintenance and Testing... 25 Packaging... 28 Sterilization... 29 Storage... 32 6. Servicing... 33 7. W&H Accessories and spare parts... 34 8. Technical data... 35 9. Disposal... 39 Explanation of warranty terms... 40 Authorized W&H service partner... 41 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! Federal law restricts this device to sale by or on the order of a dentist, physician, 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.

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 / indications for use (only for USA) Dental contra-angle handpiece for mechanical root canal preparation on patients, using rotary root canal instruments or root canal hand instruments with alternating 60° movement. Misuse may damage the handpiece 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 physician target group.

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 41).

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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. 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 >> 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). >> Always ensure the correct operating conditions. >> 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. >> Only attach the medical device onto the motor when the motor is at a complete standstill. >> Do not activate the push-button 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! >> Perform a test run each time before using. >> Do not touch the soft tissue with the contra-angle head (risk of burning due to the push-button heating up)! 9

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

Endea Endo Cursor Endea Endo Cursor  Push-button w grip profile e sheath

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3. Product description

Endea NiTi, Endea Endea NiTi Endea  push button w grip profile e sheath

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4. Operation

Assembly / Removal Do not assemble / remove the medical device during operation!  Fit the contra-angle handpiece onto the motor until it snaps into place. w Check the secure hold on the motor.

e Remove the the medical device by pulling in an axial direction. 13

Root canal instrument >> Use only perfect root canal instruments and follow the manufacturer‘s instructions. >> Only insert the root canal instrument when the medical device is stationary. >> Never touch the root canal instrument while running. >> Do not activate the push-button 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! >> W&H recommend the use of rubber dam.

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Changing the root canal instrument  Endo NiTi / Endea: Insert root canal instrument until the limit stop (a) and turn until it engages (b). Endea Endo Cursor: Insert the root canal hand instrument. Push the press button (c) firmly, at the same time insert the root canal hand instrument until limit stop (d). wVerify full engagement. e Remove the root canal instrument by pushing the push button.

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Test run Do not hold the medical device at eye level! >> Insert the root canal instrument. >> Start the medical device. In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating) 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 cleaningagents and/or disinfectants. >> Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metaland 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, for example: the Verbund für Angewandte Hygiene e.V. (VAH = Association for Applied Hygiene), the Österreichische 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. >> 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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Hygiene and maintenance

Initial treatment at the point of use

Clean the medical device immediately after every treatment, to flush out any 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 root canal 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. 20