Synea Fusion 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... 12 4. Operation... 14 Assembly / Removal... 14 To change the rotary instrument... 16 Test run... 19

5. Hygiene and maintenance... 20

General notes... 20 Limitations on processing... 22 Initial treatment at the point of use... 23

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Manual cleaning... 24 Manual disinfection...27 Automated cleaning and disinfection... 28 Drying... 29 Inspection, Maintenance and Testing...30 Packaging... 34 Sterilization... 35 Storage... 38

6. Servicing... 39 7. W&H Accessories and spare parts... 40 8. Technical data... 41 9. Disposal... 45 Explanation of warranty terms... 46 Authorized W&H service partners... 47 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

Sterilizable up to the stated temperature

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

Serial number

Medical Device

Date of manufacture Thermo washer disinfectable

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. 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 / indications for use (only for USA) The dental handpiece/contra-angle 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.

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 47).

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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 > 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. > 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! > It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the treatment water decontamination system, as well as its handling.

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> 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).

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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, the nozzle cleaner, the bur limit stop and threaded pin.

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3. Product description

Straight handpiece  Handpiece sleeve with twist chucking w Spray nozzles e Grip profile r Threaded pin t Bur limit stop y Nozzle cleaner

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Product description

Contra-angles

WG-56 LT WG-57 LT WG-66 LT

WG-99 LT

 Push-button w Spray nozzle e Compact glass rod* r Grip profile t Nose* y Nozzle cleaner * only contra-angles with light

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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 and turn until it engages audibly. w Verify full engagement. e 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 medical device. Risk of burning due to the push-button heating up!

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Contra-angles To change the rotary instrument  Rotary instrument shank ø 1.6 mm: Insert rotary instrument. Activate the button firmly (c), at the same time insert the rotary instrument until the limit stop (a). Rotary instrument shank ø 2.35 mm: Activate the button (c), at the same time insert the rotary instrument and turn it until it engages (b). w Verify full engagement.

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e Remove the rotary instrument by pushing the push-button.

Straight handpieces Inserting the rotary instrument  Rotate the handpiece sheath in an anticlockwise (O ) direction (opening) until it clicks. w Handpiece bur: Insert the rotary instrument up to the limit stop. Contra-angle handpiece bur: Insert the bur limit stop and then insert the rotary instrument up to the limit stop. The bur limit stop compensates for the difference in length. e Rotate the handpiece sheath in a clockwise (O) direction (closing) until it clicks. r Verify full engagement. 17

Straight handpiece Removing the rotary instrument  Rotate the handpiece sheath in an anticlockwise ( O ) direction (opening) until it clicks. w Handpiece bur: Remove the rotary instrument. Contra-angle handpiece bur: Screw the threaded pin clockwise into the bur limit stop and pull the latter out. e Rotate the handpiece sheath in a clockwise (O) direction (closing) until it clicks.

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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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