Instructions for Use. Contra-angle handpieces. Endea Endo Cursor EB-62 Endea EB-75 / EB-79. Contra-angle handpieces. Endo NiTi WD-73 M / WD-74 M

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1 Instructions for Use Contra-angle handpieces Endea Endo Cursor EB-62 Endea EB-75 / EB-79 Contra-angle handpieces Endo NiTi WD-73 M / WD-74 M

2 Contents W&H Symbols Introduction Before use Safety notes Product description Operation Assembly/Removal, Changing root canal instruments, Test run 5. Hygienic Maintenance General, Pre-disinfection, Manual cleaning, Manual disinfection, Mechanical cleaning and disinfection, Oil service, Sterilization 6. W&H Accessories Technical Data Recycling and Disposal...26 Letter of Indemnity Authorized W&H service partner

3 W&H Symbole WARNING! (risk of injury) ATTENTION! (to prevent damage occurring) General explanations, without risk to persons or objects Thermo washer disinfectable Sterilizable up to the stated temperature Data Matrix Code for product identification, e.g. in hygienic maintenance process Only for USA Caution! Federal law restricts this device to sale by or on the order of a dentist, physician or any other practitioner licensed by the law of the State in which he or she practices to use or order the use of the device. 3

4 1. Introduction Customer satisfaction is the main priority under the W&H quality policy. This W&H product has been developed, manufactured and subjected to final inspection according to legal regulations, quality norms 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 W&H product and guarantee a smooth and efficient operation. Intended use Dental contra-angle handpiece for mechanical root canal preparation on patients, using rotary root canal instruments or root canal hand instruments with alternating 60 movement. Misuse can damage the handpiece and involves risk and danger to the user and third parties. 4

5 Production according to EU directive This contra-angle handpiece is a medical product according to the EU-directive 93/42/EEC. Skilled application This medical product is intended only for informed use in the medical dental field according to its purpose of use in compliance with the valid health and safety at work regulations, the valid accident prevention regulations as well as in compliance with these Instructions for Use. The contra-angle should be maintained according to the manufacturer s recommendations and in line with infection control procedures for the safety and well-being of patients. Improper use, e.g. poor hygienic 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. Service In case of service or repair contact an authorized W&H service partner (see Page 29). Service and maintenance work must only be carried out by authorized W&H service partner. 5

6 2. Before use Safety notes > Always ensure the correct operating conditions. > Check the contra-angle handpiece for damage and loose parts prior to use (e.g. press button). > Use only non-contaminated, filtered, oil-free and dry compressed cooling air to operate the contra-angle handpiece. > The operation of the contra-angle with light is permitted only on dental units which correspond to the standards IEC (EN ) and IEC (EN ). Hygienic maintenance prior to initial use The contra-angle handpiece is in a clean condition and sealed in PE-film when delivered. Lubricate prior to initial use and sterilize the contra-angle handpiece and the nozzle cleaner. > Oil service Page 18 > Sterilisation Page 20 6

7 3. Product description Endea Endo Cursor press button grip profile sheath 7

8 Endo NiTi Endea Endo NiTi press button grip profile sheath Endea 8

9 4. Operation Assembly and removal Do not assemble/remove during the operation! Fit the contra-angle handpiece onto the motor until it snaps into place. Check the secure hold on the motor. Remove the contra-angle handpiece from the motor by pulling in an axial direction. 9

10 Root canal instrument > Use only perfect root canal instruments and follow the manufacturer s instructions. > Only insert the root canal instrument when the contra-angle is stationary. > Never touch root canal instruments while running or slowing down. > Never touch the press button of the contra-angle handpiece during use or while slowing down. This can cause loosening of the root canal instrument or the press button to become hot. > W&H recommend the use of rubber dam. 10

11 Changing the root canal instrument Endo NiTi / Endea: Insert root canal instrument until back stop (a) and turn until it engages (b). Endea Endo Cursor: Insert the root canal hand instrument. Push the press button (c) firmly, at the same time insert the root canal hand instrument until back stop (d). Check secure location by applying slight axial tension. Remove the root canal instrument by pushing the press button. 11

12 Test run > Insert root canal instrument. > Start the contra-angle handpiece. > If you observe problems (e.g. vibrations, unusual noise, overheating) stop the contra-angle handpiece immediately and contact an authorized W&H service partner (see page 29). 12

13 5. Hygienic Maintenance > Follow your country-specific directives, standards and guidelines for cleaning, disinfection and sterilization. > The contra-angle handpiece can be prepared manually or mechanically. > Wear protective clothing. > Remove the root canal instrument. > Remove the contra-angle handpiece from the motor. > Clean and disinfect the contra-angle handpiece immediately after every application to flush out any liquid (e. g. blood, saliva, etc.), which may have seeped in and to prevent settling on the internal parts. > Sterilize the contra-angle following manual or mechanical cleaning, disinfection, and lubrication. 13

14 Pre-disinfection > If heavily soiled: Clean first with disinfectant cloths. Only use disinfectants that have no proteinfixing effects. 14

15 Manual cleaning internal and external Rinse under demineralized water (< 38 C) with the aid of a brush. Remove any liquid residues (absorbent cloth, blow dry with compressed air). Do not place the contra-angle handpiece in liquid disinfectant or in an ultrasonic bath! 15

16 Manual disinfection W&H recommends wiping down with disinfection. > Use only disinfectants which do not contain chlorine and which are certified by officially recognized institutes. For USA: Use EPA registered disinfectants. > Note the manufacturer s specifications for the use of the disinfectants. After manual cleaning, disinfection and lubrication you must carry out a final thermal disinfection (unwrapped) or sterilization (wrapped) in the class B or S steam sterilizer (according to EN 13060). 16

17 Mechanical cleaning and disinfection internal and external Contra-angles handpieces with this symbol can be cleaned and disinfected in a thermo washer disinfector. W&H recommends processing with thermo washer disinfector. > Note the manufacturer s specifications on equipment, cleaning agents and detergents. > Make sure, that the contra-angle handpiece is completely dry internally and externally after thermo washer disinfection. Remove any liquid residues with compressed air. > Lubricate the dry contra-angle handpiece immediately after thermo washer disinfection. 17

18 Oil service With W&H Service Oil F1, MD-400 > Follow the Instructions for use of the oil spray can. With W&H Assistina > See Instructions for use of Assistina. Recommended lubrication cycles: > Essential after every internal cleaning > Before each sterilization or > After 30 minutes of use or. at least once daily 18

19 Test run following oil service Place the contra-angle handpiece with the instrument head downwards. Start the contra-angle handpiece for 30 seconds to remove excess oil. Start at the minimum speed and increase to the maximum speed within 5 to 10 seconds. > Repeat the entire hygienic maintenance process if dirt emerges. Wipe the contra-angle handpiece with gauze or a soft cloth. 19

20 Sterilization and storage W&H recommends sterilization according to EN 13060, class B > Note the instructions of the unit manufacturer. > Clean, disinfect and lubricate before sterilizing. > Wrap the contra-angle handpiece and accessories in sterile goods packaging according to EN > Make sure, that you only remove dry sterile goods. > Store sterile goods dust-free and dry. 20

21 Approved sterilization methods Observe your country-specific guidelines, standards and requirements. > Steam sterilization class B with sterilizers in accordance with EN Sterilization holding time a minimum of 3 minutes at 134 C or > Wasserdampf-Sterilisation Klasse S mit Sterilisatoren gemäß EN The sterilizer manufacturer must give their express approval for the sterilization of contra-angle handpieces. Sterilization holding time a minimum of 3 minutes at 134 C 21

22 6. W&H Accessories Use only original W&H accessories and spare parts! Suppliers: W&H partners 301 W&H Assistina W&H Service Oil F1, MD-400 (6 pcs) Spray cap with nozzle for contra-angle handpieces 22

23 7. Technical data Endea Endo Cursor EB-62 Transmission ratio 4:1 Motor coupling in accordance with standard ISO 3964 Recommended root canal instruments* Grip diameter (mm) Root canal hand instruments Ø Min. chuck length (mm) until back stop Max. motor speed (Upm) 6,000 * In choosing the correct operating conditions, the user must ensure that there is no risk to the user, the patient or third parties. Always follow the instructions of the manufacturer of the root canal instruments (e.g. in terms of speed, chuck length, described application). 23

24 Technical data Endo NiTi WD-73 M WD-74 M Transmission ratio 70:1 128:1 Motor coupling in a accordance with standards ISO 3964 Recommended root canal instruments* NiTi files for rotation root canal preparation Instrument shaft diameter (type 1) in accordance with EN ISO :1995 (mm) Ø 2.35* min. chuck length (mm) engaging max. motor speed for NiTi files from rpm: produces an application speed of: max. motor speed for NiTi files from 600 rpm: produces an application speed of: 25, rpm 40, rpm 40, rpm * In choosing the correct operating conditions, the user must ensure that there is no risk to the user, the patient or third parties. Always follow the instructions of the manufacturer of the root canal instruments (e.g. in terms of speed, chuck length, described application). 24

25 Technical data Endea EB-75 EB-79 Transmission ratio 16:1 2:1 Motor coupling ISO 3964 Recommended root canal instruments* NiTi files for rotation root canal preparation Instrument shaft diameter (Ttyp 1) according to standard EN ISO :1995 (mm) Ø 2.35* Min. chuck length (mm) engaging Max. motor speed for NiTi files from rpm: produces an application speed of:: 5, rpm rpm Max. motor speed for NiTi files from 600 rpm: produces an application speed of: 10, rpm 1, rpm Max. motor speed for NiTi files from 1,200-2,500 rpm: produces an application speed of: 25,000 1,562 rpm 2,500 1,250 rpm 5,000 2,500 rpm * In choosing the correct operating conditions, the user must ensure that there is no risk to the user, the patient or third parties. Always follow the instructions of the manufacturer of the root canal instruments (e.g. in terms of speed, chuck length, described application). 25

26 8. Recycling and Disposal Recycling W&H is committed to environmental protection. The contra-angle handpiece along with its packaging has been designed to be as environmentally friendly as possible. Disposal of the contra-angle handpiece Follow your country-specific laws, directives, standards and guidelines. Disposal of the packaging material All packaging materials can be recycled and have been selected for environmetal compliance. Please dispose of packaging materials at your local recycling facility. In this way, you will contribute to the recycling of raw materials and avoid waste. 26

27 Letter of indemnity This W&H product has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantee faultless operation. Please note that claims under warranty can only be validated when all the directions in the instructions for use have been followed. As manufacturer, W&H is liable for material or manufacturing defects within a warranty period of 24 months from the date of purchase. We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized to do so by W&H! Claims under warranty accompanied by proof of purchase must be sent to the vendor or to an authorized W&H service partner. The provision of service under warranty extends neither the warranty period nor any other guarantee period. 24 months warranty

29 Authorized W&H service partner Find you nearest W&H service partner at Simply go to the menu option»service«for full details. Alternatively please contact: W&H (UK) LIMITED, 6 Stroud Wood Business Centre, Park Street, St Albans, Herts AL2 2NJ, United Kingdom t , f , technical.uk@wh.com W&H Impex Inc., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9, Canada t , , f , service.ca@wh.com W&H Impex Inc., Henn Rd., Dearborn, MI 48126, USA t , , f , service.us@wh.com W&H Austria GmbH, Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria t , f , office.at@wh.com A-DEC AUSTRALIA CO. INC., Unit 8, 5-9 Ricketty Street, Mascot NWS 2020, Australia t , f , a-dec@a-dec.com.au 29

30 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria t , f office@wh.com wh.com Form-Nr AEN Rev. 002 / Subject to alterations

Instructions for use. 400 series. Highspeed Air Handpieces. valid since serial no

Instructions for use. 400 series. Highspeed Air Handpieces. valid since serial no Instructions for use 400 series Highspeed Air Handpieces valid since serial no. 01001 Contents A-dec W&H symbols... 3 4 1. Introduction... 5 7 2. Safety notes... 8 11 3. Product description...12 13 4.