Proxeo Straight and Contra- Angle 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... 11 4. Operation... 12 Assembly/Removal...12 To change the rotary instrument... 15 Test run... 23

5. Hygiene and maintenance... 24

General notes... 24 Limitations on processing... 26 Initial treatment at the point of use...27

2

Manual cleaning... 28 Manual disinfection... 29 Automated cleaning and disinfection...30 Drying... 31 Inspection, Maintenance and Testing... 32 Packaging... 36 Sterilization...37 Storage...40

6. Servicing... 41 7. W&H Accessories and spare parts... 42 8. Technical data... 43 9. Disposal... 45 Explanation of warranty terms... 46 Authorized W&H service partners... 47 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

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 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 authorized W&H service partner (see page 47).

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!

8

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 supply units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). >> Use only filtered, oil-free and cooled air supplied by dental compressors to operate the medical device. >> 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.

9

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.

10

3. Product description

Straight handpiece/contra-angle handpiece 



HP-44 M, HP-44 T, HP-44 TS

 HP-44 T SD

 HP-44 T MW 



WP-64 MU

 Nose  StarDental® connection  Retention sleeve  Midwest® connection  Thread  Shaft  Spanner i Snap-on adaptor  Push-button (WP-66 M)

WP-64 M, WP-64 T, WP-64 TS





i WP-66 M 11

4. Operation

Assembly/Removal ISO connection Do not assemble or remove the medical device during the operation!  Push the medical device onto the motor. w Verify full engagement. e Remove the medical device. HP-44 TS, WP-64 TS can only be operated on dental motors with an ISO coupling measuring no longer than 23 mm.

12

Midwest® connection Do not assemble or remove the medical device during the operation!

 

 Push the medical device onto the motor.

 

w Verify full engagement.  Press the locking sheath.  Remove the medical device from the motor.

13

StarDental® connection



Do not assemble or remove the medical device during the operation!



 Push the handpiece onto the motor. w Verify full engagement.



14

 Pull the retention sleeve of the handpiece to remove it from the motor.

Operation

To change the rotary instrument

Rotary instruments >> Prophy Angle Cup or Brush >> Prophy Cup or Brush >> Snap-on adaptor for Prophy Cup or Brush

2 >> The rotary instruments are disposable articles and must be discarded after each treatment. >> Use only rotary instruments which are in perfect condition. Follow the operating instructions of the manufacturer. >> Use only rotary instruments (for WP-66 M) which have shanks that meet the requirements of the ISO 1797 standard. >> Insert the rotary instrument only when the medical device is stationary. >> Never touch the rotary instrument while it is still rotating. 15

>> Only use the medical device in forward operation. The rotary instrument can come loose in reverse operation (risk of injury). >> 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! HP-44 M, HP-44 T, HP-44 TS, HP-44 T MW, HP-44 T SD straight handpiece (Prophy Angle with plastic shank, Doriot system) >> The straight handpiece has an automatic clamping chuck system. >> Only use Prophy Angles with plastic shanks for the Doriot system. Prophy Angles with metal shanks damage the clamping chuck system.

16

WP-64 M, WP-64 T, WP-64 TS contra-angle handpiece (Young system) >> The contra-angle handpiece head is equipped with a triple seal from Young Dental. >> To ensure tightness only use Young Dental Prophy Cups or Brushes for the screw-in system.

WP-64 MU contra-angle handpiece (Universal system) >> The contra-angle handpiece head is equipped with a W&H seal. >> You can use any popular screw-in (screw thread 1-72 UNF 2A) or snap-on Prophy Cups or Brushes.

17

HP-44 M, HP-44 T, HP-44 TS, HP-44 T MW, HP-44 T SD straight handpiece >> Prophy Angle Cup or Brush  Position the groove on the Prophy Angle with the nose of the straight handpiece. w Push the Prophy Angle onto the straight handpiece until the limit stop.  Verify full engagement.  Remove the Prophy Angle.

18

WP-64 M, WP-64 MU, WP-64 T, WP-64 TS contra-angle handpiece >> Prophy Cup or Brush a) b)

c)

 Lock the shaft of the contra-angle handpiece with the spanner. w a) Screw the Cup or Brush in until the limit stop. b) Verify full engagement. c) Unscrew the Cup or Brush.

19

WP-64 MU contra-angle handpiece >> Snap-on adaptor >> Prophy Cup or Brush  Lock the shaft of the contra-angle handpiece with the spanner. w Screw the adaptor in until the limit stop. e Fit the Cup or Brush on the adaptor.  Verify full engagement. or

20