Roto Quick coupling Instructions for Use

Contents W&H Symbols... 4 1. Introduction... 6 2. Safety notes... 10 3. Product description...14 4. Operation...16 Connecting the Quick coupling... 16 Disconnecting the Quick coupling... 17 Changing air driven products... 19 Test run...22 5. Hygiene and maintenance...23 General notes...23 Limitations on processing...25 2

Initial treatment at the point of use...26 Manual cleaning...27 Manual disinfection...28 Inspection, Maintenance and Testing... 29 Packaging...30 Sterilization... 31 Storage...34 6. Maintenance... 35 7. Servicing...40 8. W&H Accessories and spare parts ... 41 9. Technical data ...42 10. Disposal...44 Explanation of warranty terms... 45 Authorized W&H service partner... 47 3

W&H Symbols

WARNING! (Risk of injury)

in the Instructions for use

ATTENTION! (to prevent damage occurring)

General explanations, without risk to persons or objects

W&H Symbols Medical Device 4

Do not dispose of with domestic waste on the medical device/packaging

Type B applied part (not suitable for intracardiac application)

W&H 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)

Catalogue number

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

Serial number Date of manufacture

Data structure in accordance with Health Industry Bar Code Sterilizable up to the stated temperature

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 is the main priority under the W&H quality policy. This medical device has been developed, manufactured and subjected to final inspection according to legal regulations, quality norms and industry standards. For your safety and for 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.

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Intended use Connector for media transfer (air, water, electricity an light) between the supply hose and the dental unit and air driven motors Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. 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 Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. 7

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. >> Only the components approved by the manufacturer may be replaced (e.g. o-rings). >> Modifications or repairs must only be undertaken by an authorized W&H service partner. (see page 47) >> Correct the malfunction as described in the Instructions for use.

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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. > 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). The power supply unit for the dental unit must satisfy the following requirements to be guaranteed by the system assembler (Relates to externally electrically supplied couplings and applied parts): > Double insulation for the highest expected supply voltage must be provided between the primary and secondary power circuits. > Double insulation for the highest expected secondary voltage must be provided between the secondary voltage and protective earth (PE). 10

> The secondary circuits must be galvanically isolated from each other. > The secondary circuits must be protected against short-circuiting and overloading. (maximum 700 mA only for RA-24) > The leakage currents of and between the applied parts must be kept. > The secondary voltage to supply this medical device must must be limited to a maximum of 4.2 V AC or 6 V DC. (3.3 V AC/DC only for RA-24) > > > > > > > >

Never touch the patient and the electrical contacts on the medical device simultaneously. Use only the supply hoses as specified by EN ISO 9168. Always ensure the correct operating conditions and cooling function. Check the medical device for damage and loose parts before using. Do not operate the medical device if it is damaged. Perform a test run each time before using. Do not look directly into the light source. Do not use the medical device as a light probe.

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> The Quick coupling is a functional part of the supply hose and should therefore also be seen as an extension to it during reprocessing. 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. (except RQ-14, RQ-34) If the Quick coupling is processed separately from the supply hose, you can refer to the information in the chapter “Hygiene and maintenance” as per ISO 17664 from the manufacturer of the quick coupling. The medical device is not approved for operation in potentially explosive atmospheres (only for RA-24).

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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 and disinfect the medical device. >> Sterilize the medical device (only for sterilizable types).

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3. Product description  O-rings  Retention sleeve  Spray regulation ring (for RQ-14, RQ-34)  Water filter with resuction stop

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All Quick couplings are equipped with a non-retraction valve which prevents contaminated cooling water from being sucked back into the turbine and the supply hose. The non-retraction valve is integrated in the cooling water supply system. In the event of blocked or incorrectly routed cooling water lines, please contact an authorized W&H service partner (see page 47). The cooling water lines must not be cleaned with sharp objects! (This could damage the sealing element and prevent the non-retraction valve from working.)

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4. Operation

Connecting the Quick coupling  Connect the Quick coupling to the supply hose.  Firmly tighten the union nut of the supply hose by hand in a clockwise direction to ensure there are no leaks. Verify full engagement. Check the leak tightness.

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This method of assembly provides a connection for drive air, chip air, return air, water. Possible variants with electricity: RQ-24, RQ-34 or with light: RA-24, RA-25.

Operation

Disconnecting the Quick coupling  Unscrew the union nut of the supply hose by hand in an anticlockwise direction.  Carefully remove the Quick coupling from the supply hose.

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Checking the Quick coupling for leaks > Push an appropriate air driven medical product onto the Quick coupling. > Activate the medical device, or if possible just activate the spray water only. > No water should leak between the Quick coupling and the air driven medical product, and the coupling and the supply hose.

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Operation

Changing air driven products

> Always follow recommendations made by the manufacturer of air driven products. > Only connect air driven product with appropriate connection to the Quick coupling. > The user accepts sole responsibility if other air driven products are used. We accept no liability in such cases.

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Operation

Changing air driven products Do not assemble or remove the medical device during the operation.

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 Attach the air driven instrument onto the Quick coupling until it audibly engages.

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 Verify full engagement 

 Pull the retention sleeve of the Quick coupling back.  To disconnect the air driven instrument, pull it off in axial direction.