Surgical Saw handpieces Instructions for Use

Contents Symbole... 4 in the Instructions for use...4 on the medical device / packaging...5

1. Introduction... 6 2. Safety notes... 9 3. Product description... 12 4. Operation... 14 5. Hygiene and maintenance... 18 General notes... 18 Limitations on processing... 20 Initial treatment at the point of use...21 Manual cleaning... 22 Manual disinfection... 27 Automated cleaning and disinfection... 28

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Drying... 30 Inspection, Maintenance and Testing... 31 Packaging... 36 Sterilization... 37 Storage... 39

6. Servicing... 40 7. W&H Accessories and spare parts... 41 8. Technical data... 42 9. Disposal... 44 Explanation of warranty terms... 45 Authorized W&H service partners... 46

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Symbole

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

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

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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 Saw handpieces for cutting and separating bone substances mechanically in cranio-maxillo-facial surgery (CMF). 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 authorized W&H service partner (see page 46). 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 dental 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. >> In case of coolant supply failure, the medical device must be stopped immediately. >> 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 micromotor when the micromotor is at a complete standstill. >> Perform a test run each time before using. >> Avoid overheating at the treatment site. >> The maximum permitted drive speed of 40,000 rpm must not be exceeded. >> Tighten the clamping screw fully only when you have inserted a saw blade (risk of breakage). 9

Safety notes >> Only use saw blades that are in perfect condition and be careful when the saw blade is moving. >> Follow the operating instructions of the manufacturer. >> Use only saw blades approved by W&H. >> Change the saw blades after every treatment. >> Insert the saw blade only when the medical device is stationary. >> Do not interfere with the running or slowing down saw blade. >> Contact between the tissue and the saw blade may result in injury.

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Saw blades

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 saw blades, the coolant tube, the spanner and the nozzle cleaner.

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3. Product description  Clamping screw  Handpiece tip S-8R

S-8S S-8S

S-8R

S-8O

 Drive shaft  Shaft  Sheath  External coolant tube  Spanner  Nozzle cleaner  Symbol description

S-8O

❍ Sheath open ● Sheath locked S-8R / S-8S

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S-8O

Product description

W&H saw blades

 Reciprocating

R-15, R-20, R-30

 Sagittal

S-6, S-10  Oscillating O-8, O-15

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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. When using a locking pin between motor and medical device: See Instructions for use of the control unit.

 Verify full engagement.  Remove the medical device. 14

To change saw blade

 Undo the clamping screw with the spanner or by hand. Ensure that the sheath remains closed.

 Insert the blade up to the limit stop or remove it. Only for S-8O: Press the saw blade and turn it until it engages audibly.

S-8O

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 Guide the spanner to the clamping screw.

Use the spanner to tighten the clamping screw.

 Verify full engagement.

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Test run Do not hold the medical device at eye level! >> Insert saw blade. >> 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.

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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 500 processing cycles or one year.

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