W&H Surgical Handpiece 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 4. Start-up... 12 Assembly/Removal...12 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

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Manual disinfection... 24 Automated cleaning and disinfection... 25 Drying... 27 Inspection, Maintenance and Testing... 28 Packaging... 32 Sterilization... 33 Storage... 35

6. Servicing... 36 7. W&H Accessories and spare parts... 37 8. Technical data ... 38 9. Disposal... 40 Explanation of warranty terms... 41 Authorized W&H service partners... 42

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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

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 intends to use or order the use of this medical device. 4

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 Date of manufacture

Medical Device UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements 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 Surgical treatment of organic hard tissue. 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 physician 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 authorised W&H service partner (see page 42). 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. 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 and cooling function. >> Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction. >> Always ensure that you have a second medical device ready for use during the operation. >> Check the medical device for damage and loose parts each time before using. >> 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. >> Perform a test run each time before using. >> Avoid overheating at the treatment site.

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The use of the medical device on surgical units other than the Implantmed SI-9xx, SI-10xx, Elcomed SA-2xx and SA-3xx, in particular those without a calibration function, represents a risk which must be considered by the user (risk of injury). W&H explicitly advises against doing this. The user is solely responsible. The manufacturer accepts no liability.

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, the nozzle cleaner, and the coolant tube. 10

3. Product description  Sheath  Chuck ring*  Handpiece head  Coolant tube  Nozzle cleaner

* Symbol on the part  = Chucking system open = Direction of rotation = Chucking system locked 11

4. Start-up

Assembly/Removal Coolant tube

 Fit the coolant tube.  Insert the coolant tube into the irrigation tubing. or

 Remove the irrigation tubing.  Pull off the coolant tube.

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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 and pay attention to the direction of rotation of the rotary instrument. 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.

When having a torque higher than 30 Ncm on the rotary instrument you have to use hardened shafts (>50 HRC, >520 HV) (risk of deformation).

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To change the rotary instrument >> With hexagon >> Instrument shaft diameter 2.35 mm To open the chucking system: Turn the chuck ring to the left To close the chucking system: Turn the chuck ring to the right

 Open the chucking system.  Insert the rotary instrument until limit stop.  Close the chucking system.  Verify full engagement.  Open the chucking system.  Remove the rotary instrument. 15

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, for example: 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.

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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 250 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 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 coolant outlets are rinsed out. >> Wipe the entire surface of the medical device 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. 20