W&H Endea Endo Cursor EB-62, Instructions For Use Manual

Page 1: ...Contra angle handpieces Endea Endo Cursor EB 62 Endea EB 75 EB 77 EB 79 Contra angle handpieces Endo NiTi WD 73 M WD 74 M Instructions for use...

Page 2: ...ackaging 5 1 Introduction 6 2 Safety notes 9 3 Product description 11 Endea Endo Cursor 11 Endea NiTi Endea 12 4 Operation 13 Assembly Removal 13 Changing the root canal instrument 15 Test run 16 5 Hy...

Page 3: ...Automated cleaning and disinfection 23 Drying 24 Inspection Maintenance and Testing 25 Packaging 28 Sterilization 29 Storage 32 6 Servicing 33 7 W H Accessories and spare parts 34 8 Technical data 35...

Page 4: ...in the Instructions for use WARNING risk of injury ATTENTION to prevent damage occurring General explanations without risk to persons or objects Do not dispose of with domestic waste Symbols 4...

Page 5: ...ecognition Mark indicates compliance with Canadian and U S requirements Serial number Date of manufacture XXXX Thermo washer disinfectable Sterilizable up to the stated temperature Caution Federal law...

Page 6: ...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 o...

Page 7: ...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 Ins...

Page 8: ...ld 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 co...

Page 9: ...nd loose parts each time before using e g push button Do not operate the medical device if it is damaged Only attach the medical device onto the motor when the motor is at a complete standstill Do not...

Page 10: ...rior 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 Steril...

Page 11: ...3 Product description Endea Endo Cursor Endea Endo Cursor Push button w grip profile e sheath 11...

Page 12: ...Endea NiTi Endea push button w grip profile e sheath 3 Product description Endea NiTi Endea 12...

Page 13: ...not assemble remove the medical device during operation Fit the contra angle handpiece onto the motor until it snaps into place wCheck the secure hold on the motor e Remove the the medical device by p...

Page 14: ...ent when the medical device is stationary Never touch the root canal instrument while running Do not activate the push button of the medical device during operation This leads to detachment of the rot...

Page 15: ...limit 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 limit stop...

Page 16: ...e at eye level Insert the root canal instrument Start the medical device In the event of operating malfunctions e g vibrations unusual noise overheating stop the medical device immediately and contact...

Page 17: ...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 wi...

Page 18: ...fied by the manufacturer of the disinfectant Use disinfectants which have been tested and found effective by for example the Verbund f r Angewandte Hygiene e V VAH Association for Applied Hygiene the...

Page 19: ...ainly determined by mechanical stress during use and chemical influences due to processing Send worn or damaged medical devices and or medical devices with material changes to an authorized W H servic...

Page 20: ...on the internal parts Operate the medical device for at least 10 seconds at idle speed Ensure that all outlets are rinsed out Wipe the entire surface of the instrument with disinfectant Remove the ro...

Page 21: ...evice in liquid disinfectant or in an ultrasonic bath Clean the medical device under running tap water 35 C 95 F Rinse and brush off all internal and external surfaces Move moving parts back and forth...

Page 22: ...wiping down with disinfectant Evidence of the medical device s basic suitability for effective manual disinfection was provided by an independent test laboratory using the disinfectants mikrozid AF w...

Page 23: ...disinfectors cleaning agents and or disinfectants Evidence of the medical device s basic suitability for effective automated disinfection was provided by an independent test laboratory using the Miel...

Page 24: ...Hygiene and maintenance Drying Ensure that the medical device is completely dry internally and externally after cleaning and disinfection Remove any liquid residues using compressed air 24...

Page 25: ...e Inspection Check the medical device after cleaning and disinfection for damage visible residual soiling and surface changes Reprocess any medical devices that are still soiled Sterilize the medical...

Page 26: ...sential after every internal cleaning Before each sterilization or After 30 minutes of use or at least once daily Chucking system once a week With W H Service Oil F1 MD 400 Follow the instructions on...

Page 27: ...Testing after lubrication Direct the medical device downwards Operate the medical device so that excess oil can escape Excess oil may result in the medical device overheating 27...

Page 28: ...ollowing requirements The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method The sterilization package must be lar...

Page 29: ...mmends sterilization according to EN 13060 EN 285 oder ANSI AAMI ST55 Read the notes follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers The program select...

Page 30: ...al prevacuum cycle type B Steam flush pressure pulse cycle type S 134 C 273 F for at least 3 minutes 132 C 270 F for at least 4 minutes Gravity displacement cycle type N 121 C 250 F for at least 30 mi...

Page 31: ...CertoClav GmbH Traun Dynamic air removal prevacuum cycle type B 134 C 273 F 3 minutes 132 C 270 F 4 minutes Steam flush pressure pulse cycle type S 134 C 273 F 3 minutes 132 C 270 F 4 minutes Gravity...

Page 32: ...Hygiene and maintenance Storage Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging 32...

Page 33: ...perating malfunctions immediately contact an authorized W H service partner Repairs and maintenance work must only be undertaken by an authorized W H service partner Ensure that the medical device has...

Page 34: ...Use only original W H accessories and spare parts or accessories approved by W H Suppliers W H partners 000301xx W H Assistina 301 plus 30310000 W H Assistina TWIN MB 302 10940021 Service Oil F1 MD 40...

Page 35: ...Root canal hand instruments 3 6 4 min chuck length mm until limit stop max motorspeed rpm 6 000 In choosing the correct operating conditions the user must ensure that there is no risk to the user the...

Page 36: ...mm einrastend max motor speed for NiTi files from 300 350 rpm produces an application speed of rpm 25 000 357 40 000 312 max motor speed for NiTi files from 600 rpm produces an application speed of rp...

Page 37: ...312 1 200 300 600 300 max motor speed for NiTi files from 600 rpm produces an application speed of rpm 10 000 625 2 500 625 1 200 600 max motorspeedforNiTifilesfrom1 200 2 500rpm producesanapplicatio...

Page 38: ...50 C 122 F Temperature of the working part root canal instrument maximum 41 C 105 8 F Ambient conditions Temperature during storage and transport 40 C to 70 C 40 F to 158 F Humidity during storage an...

Page 39: ...9 Disposal Ensure that the parts are not contaminated on disposal Instrument disposal Follow your local and national laws directives standards and guidelines for disposal Medical device Packaging 39...

Page 40: ...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...

Page 41: ...Authorized W H service partners Find your nearest authorized W H service partner at http wh com Simply go to the menu option Service for full details Or simply scan the QR code 41...

Page 42: ...Form Nr 50669 AEN Rev 005 24 08 2021 Subject to alterations Manufacturer W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com...