W&H endea EB-62 Скачать руководство пользователя страница 7 | Manualshive

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Qualifications of the user

We have based our development and design of the medical device on the dentists target group.

Production according to EU Directive

The medical device meets the requirements of Directive 93/42/EEC.

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 41).

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Содержание endea EB-62

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

Страница 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...

Страница 3: ...nual cleaning 23 Automated cleaning and disinfection 24 Drying 25 Inspection Maintenance and Testing 26 Packaging 29 Sterilization 30 Storage 32 6 Servicing 33 7 W H Accessories and spare parts 34 8 T...

Страница 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...

Страница 5: ...mponent Recognition 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 Ac...

Страница 6: ...tients 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 Denta...

Страница 7: ...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 medic...

Страница 8: ...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 patie...

Страница 9: ...k the medical device for damage and 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 i...

Страница 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...

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

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

Страница 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...

Страница 14: ...e root canal instrument when the medical device is stationary Never touch the rotary instrument while it is still rotating Do not activate the push button of the medical device during operation This l...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 22: ...Hygiene and maintenance Automated cleaning and lubrication W H recommends automated cleaning and lubrication with W H Assistina 3x3 Follow the instructions in the Assistina Instructions for use 22...

Страница 23: ...ecommends 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 mikrozid AF wipes...

Страница 24: ...rs of washer 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 us...

Страница 25: ...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 25...

Страница 26: ...ection 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 reassembled me...

Страница 27: ...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...

Страница 28: ...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 28...

Страница 29: ...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...

Страница 30: ...mmends sterilization according to EN 13060 EN 285 oder ANSI AAMI ST79 Read the notes follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers The program select...

Страница 31: ...suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L steam sterilizer Firma W H Sterilization S r l Brusaporto BG and the CertoClav MultiCont...

Страница 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...

Страница 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...

Страница 34: ...and spare parts or accessories approved by W H Suppliers W H partners 000301xx W H Assistina 301 plus 19922000 W H Assistina 3x2 MB 200 19923000 W H Assistina 3x3 MB 300 30310000 W H Assistina TWIN MB...

Страница 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...

Страница 36: ...h 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...

Страница 37: ...tionspeedof rpm 5 000 312 600 300 max motor speed for NiTi files from 600 rpm produces an application speed of rpm 10 000 625 1 200 600 max motorspeedforNiTifilesfrom1 200 2 500rpm producesanapplicati...

Страница 38: ...um 50 C 122 F Temperature of the working part rotary 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 and...

Страница 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...

Страница 40: ...or 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 th...

Страница 41: ...Inc 6490 Hawthorne Drive Windsor Ontario N8T 1J9 Canada t 1 800 2656277 1 519 9446739 f 1 519 9746121 E Mail service ca wh com W H Impex Inc 33091 W Jefferson Ave Brownstown MI 48173 USA t 1 800 265 6...

Страница 42: ...Form Nr 50669 AEN Rev 004 24 10 2018 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...

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