Piezomed Classic and Plus Handpiece with Cable Instructions for Use

Contents Symbols... 4 1. Introduction... 7 2. Safety notes... 10 3.Description... 15 4. Instruments... 16 Insert...16 Remove ...17

5. Hygiene and maintenance... 18 General notes... 18 Limitations on processing... 20 Initial treatment at the point of use...21 Manual cleaning... 22 Automated cleaning and disinfection... 27 Drying... 29

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Inspection, maintenance and testing... 30 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)

Suitable for ultrasonic bath 4

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 / on the packaging

CE marking with identification number of the Notified Body

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

Type B applied part (not suitable for intracardiac application)

Catalogue number

Sterilizable up to the stated temperature

Date of manufacture

Serial number

Thermo washer disinfectable

Manufacturer

Data structure in accordance with Health Industry Bar Code

Batch code

5

Symbols +70 °C (+158°F) Max.

on the medical device / on the packaging Temperature limitation

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

Humidity limitation

Caution! 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.

-40 °C (-40°F) Min.

80 %

8%

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1. Introduction For your safety and the safety of your patients These Instructions for use explain how to use your medical device. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance to us. Observe the safety notes. Intended use Piezoceramic oscillating system for treatment of organic hard and soft tissue in dental surgery, implantology, maxillofacial surgery and periodontics. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. 7

Qualifications of the user Only suitably qualified medical, technical and specialist trained staff may use the medical device. 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. Only the components approved by the manufacturer may be replaced (LED socket). > Unauthorized opening of the medical device invalidates all claims under warranty and any other claims.

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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! 9

2. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > Check the medical device for damage and loose parts each time before using. > Do not operate the medical device if it is damaged. > Only put the medical device into operation when the handpiece sleeve is attached. > Avoid overheating at the treatment site. > If the LED fails, change the LED socket. > Only change the LED socket when the handpiece is stationary. > Always operate the handpiece with the LED socket fitted. > Do not look directly into the light source. > Perform a test run each time before using. > Do not twist or kink the cable! Do not coil it too tightly!

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Instruments > Only use instruments approved by W&H and the associated instrument changer. > Make sure that the instrument used complies with the instrument group displayed. > An overview for the correct power setting is included with each instrument. > Ensure that the original shape of the instrument is not changed (e.g. by dropping). > Instruments must not be bent back to shape or reground. > Only insert the instrument when the handpiece is at rest. > Never touch the instrument when vibrating. > Remove the instrument from the handpiece after every treatment and place it in the instrument stand (provides protection against injury and infection). > Ensure there is sufficient coolant directly at the treatment site. > The instruments Z25P and Z35P may only be operated with a coolant setting of max. 35%.

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> Keep the handpiece moving at all times when operating the instrument. > Do not exert too much pressure on the instrument. This can cause the instrument to heat up or break, resulting in injury to the patient. > Do not make any levering motions with the instrument. > Never let the instrument run freely without coolant.

Coolant supply The medical device is designed for use with physiological saline solution. > Always ensure the correct operating conditions and cooling function. > Use only suitable coolants and follow the manufacturer's medical data and instructions. > In case of coolant supply failure, the medical device must be stopped immediately. > Use the W&H irrigation tubing set or accessories approved by W&H. > Make sure that the coolant filling function has been carried out prior to every application. 12

Risks due to electromagnetic fields This medical device complies with the reference values defined in EN 50527-2-1/2016 for active implantable medical devices (AIMD) and cardiac pacemakers.

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Hygiene and maintenance prior to initial use > Clean and disinfect the handpiece with cable, the instruments and the instrument changer. > Sterilize the the handpiece with cable, the instruments and the instrument changer.

Test run Do not hold the handpiece with cable at eye level! > Attach the handpiece with cable to the control unit. > Insert the instrument. > Put the medical device into operation. 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. 14

3.Description  Handpiece cap  Light source  LED socket  Thread  Coolant tube  Nozzle cleaner

SA-40 L

SA-40

 

 

  15

4. Instruments

Insert  Position the instrument in the instrument changer on the handpiece thread. w Turn the instrument changer until it snaps into place. e Carefully pull off the instrument changer.



w e

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Verify full engagement.

Instruments

Remove  Attach the instrument changer to the instrument. w Unscrew the instrument with the instrument changer.



Keep the instrument in the stand until a hygiene and maintenance process is carried out. w

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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. > The instruments can be reprocessed in the instrument stand (REF 07134900). > The medical device must not be oiled > The medical device must not be disassembled.

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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. 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 handpiece with cable after 250 processing cycles or one year. > We recommend to replace the instrument changer after 1000 processing cycles. > We recommend checking the instruments for material wear after 60 reprocessing cycles.

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