proxeo Twist 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. Operation... 12 Assembly/Removal...12 To change the rotary instrument... 13 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... 25 Automated cleaning and disinfection... 26 Drying...27 Inspection, Maintenance and Testing... 28 Packaging... 31 Sterilization... 32 Storage... 35

6. Servicing... 36 7. Accessories, consumables, spare parts and other recommended medical devices by W&H... 37 8. Technical data... 38 9. Disposal... 40 Explanation of warranty terms... 41 Authorized W&H service partners... 43 3

Symbols

in the Instructions for use

WARNING! (risk of injury)

2

Not for re-use

4

ATTENTION! (to prevent damage occurring)

General explanations, without risk to persons or objects

Do not dispose of with domestic waste

Symbols XXXX

CE marking with identification number of the Notified Body Catalogue number

on the medical device / packaging DataMatrix Code for product information including UDI (Unique Device Identification)

Serial number

Sterilizable up to the stated temperature

Date of manufacture

Thermo washer disinfectable

Manufacturer Consult Instructions for use

Data structure in accordance with Health Industry Bar Code Medical Device UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements

Caution! According to 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.

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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 The Proxeo straight/contra-angle handpiece is intended for cleaning and polishing the tooth surface and fillings. 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 authorised W&H service partner (see page 43).

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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! 8

2. Safety notes > Use only the medical device with the drive handpiece PL-40 HW. > Before using the medical device for the first time, store it at room temperature for 24 hours. > Always ensure the correct operating conditions. > 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.

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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.

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3. Product description

Handpiece-/contra-angle head PL-66 W System LatchShort  Push-button





PL-64 System Screw-in Young  Thread PL-44 System Doriot e Nose

w e

 W&H connection 11

4. Operation

Assembly/Removal Do not assemble or remove the medical device during operation!   Push the medical device onto the handpiece drive.

w e

w Verify full engagement. or e Remove the medical device.

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Operation

To change the rotary instrument

Rotary instruments > Prophy Cup or Brush System LatchShort > Prophy Cup or Brush System Screw-in Young > Prophy Angle Cup or Brush System Doriot

2 > The rotary instruments are disposable articles and must be discarded after each treatment. > Use only rotary instruments which are in perfect condition and approved by W&H (LatchShort). 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. 13

Contra-angle head PL-66 W (System LatchShort) > Use only rotary instruments which have shanks that meet the requirements of the ISO 1797 standard. > 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! > To reach a low working height and ensure tightness, use only W&H Prophy Cups or Brushes for the LatchShort system. Contra-angle head PL-64 (System Screw-in Young) > Only use the straight/contra-angle handpiece in forward operation. The rotary instrument can come loose in reverse operation (risk of injury).

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> The head of the contra-angle head is equipped with a Triple Seal from Young Dental. > To ensure tightness and functionality, use only Young Dental Prophy Cups or Brushes for the Screw-in system. Handpiece head PL-44 (System Doriot) > Only use Prophy Angles with plastic shanks for the Doriot system. Prophy Angles with metal shanks damage the clamping chuck system. > Follow the recommendations of the disposable contra-angle handpiece manufacturers. > The handpiece head has an automatic clamping chuck system.

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 (c)

(b)

Contra-angle head PL-66 W > Prophy Cup or Brush (System LatchShort) > Instrument shaft diameter 2.35 mm

(a)

 Push the Cup or Brush in until the limit stop (a). Press the push-button (b) and turn the Cup or Brush until it clicks into place (c). e

w Verify full engagement.

w or

 Press the push-button and remove the Cup or Brush. 16

Contra-angle head PL-64 > Prophy Cup or Brush (System Screw-in Young)  Screw the Cup or Brush in until the limit stop. w



or

e  

w Verify full engagement.



 Hold the Cup or Brush firmly.  Keep pressed the ON/OFF button of the handpiece drive.  And press the foot control.  The Cup or Brush is unscrewed. 17

Handpiece head PL-44 > Prophy Angle Cup or Brush (System Doriot)   Position the groove on the Prophy Angle with the nose of the handpiece head and push it on until the limit stop.

w

w Verify full engagement. e

or  Remove the Prophy Angle.

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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 noises or overheating) 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. The information on the validated reprocessing procedures serves as an example of an ISO 17664 compliant processing of the medical device. > 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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