Related Manuals for W&H Endea Endo Cursor EB-62
Summary of Contents for W&H Endea Endo Cursor EB-62
- Page 1 Instructions for use 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...
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Page 2: Table Of Contents
Contents Symbols....................................in the Instructions for use .................................. 4 on the medical device / packaging ..............................5 1. Introduction ..................................2.Safety notes ..................................3. Product description ................................Endea Endo Cursor .................................... 11 Endea NiTi, Endea ....................................12 4. Operation .................................... Assembly / Removal ..................................13 Changing the root canal instrument .............................. - Page 3 Initial treatment at the point of use ..............................20 Manual cleaning ....................................21 Manual disinfection ..................................22 Automated cleaning and disinfection .............................. 23 Drying ........................................ 24 Inspection, Maintenance and Testing .............................. 25 Packaging ......................................28 Sterilization ....................................... 29 Storage ....................................... 32 6.
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Page 4: Symbols
Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of with (risk of injury) (to prevent without risk to domestic waste damage occurring) persons or objects... -
Page 5: On The Medical Device / Packaging
Symbols on the medical device / packaging CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Catalogue number Sterilizable up to the Thermo washer stated temperature disinfectable... -
Page 6: Introduction
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. - Page 7 Qualifications of the user We have based our development and design of the medical device on the physician 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: >...
- Page 8 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.
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Page 9: Safety Notes
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). >... - Page 10 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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Page 11: Product Description
3. Product description Endea Endo Cursor Endea Endo Cursor Push-button w grip profile e sheath... -
Page 12: Endea Niti Endea
3. Product description Endea NiTi, Endea Endea NiTi Endea push button w grip profile e sheath... -
Page 13: Operation
4. Operation Assembly / Removal Do not assemble / remove the medical device during operation! Fit the contra-angle handpiece onto the motor until it snaps into place. w Check the secure hold on the motor. e Remove the the medical device by pulling in an axial direction. - Page 14 Root canal instrument > Use only perfect root canal instruments and follow the manufacturer‘s instructions. > Only insert the root canal instrument 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 rotary instrument, damage to the chucking system and/or heating up of the medical device.
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Page 15: Changing The Root Canal Instrument
Changing the root canal instrument Endo NiTi / Endea: Insert root canal instrument until the 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 (d). -
Page 16: Test Run
Test run Do not hold the medical device at eye level! > Insert the root canal instrument. > Start the medical device. stop the medical device In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating) immediately and contact an authorized W&H service partner. -
Page 17: Hygiene And Maintenance
5. Hygiene and maintenance General notes Follow your local and 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 with a maximum operating pressure of 3 bar for manual drying. - Page 18 Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaningagents and/or disinfectants. > Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metaland plastic. >...
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Page 19: Limitations On Processing
Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly 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 service partner. -
Page 20: Initial Treatment At The Point Of Use
Hygiene and maintenance Initial treatment at the point of use Clean the medical device immediately after every treatment, to flush out any liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. > Operate the medical device for at least 10 seconds at idle speed. >... -
Page 21: Manual Cleaning
Hygiene and maintenance Manual cleaning Do not place the medical device 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. >... -
Page 22: Manual Disinfection
Hygiene and maintenance Manual disinfection > W&H recommends 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 wipes” (Schülke & Mayr GmbH, Norderstedt) and “CaviWipes™”... -
Page 23: Automated Cleaning And Disinfection
Hygiene and maintenance Automated cleaning and disinfection W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). > Read the notes, follow the instructions and heed the warnings provided by the manufacturers 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 using the “Miele PG 8582 CD”... -
Page 24: Drying
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. -
Page 25: Inspection, Maintenance And Testing
Hygiene and maintenance Inspection, Maintenance and Testing 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 device following cleaning, disinfection and lubrication. - Page 26 Lubrication > Lubricate the dry medical device immediately after cleaning and/or disinfection. Recommended lubrication cycles > Essential after every internal cleaning > Before each sterilization > After 30 minutes of use or at least once daily > Chucking system once a week With W&H Service Oil F1, MD-400 >...
- 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.
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Page 28: Packaging
Hygiene and maintenance Packaging Pack the medical device and the accessories in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. >... -
Page 29: Sterilization
Hygiene and maintenance Sterilization W&H recommends 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 selected must be suitable for the medical device. - Page 30 Recommended sterilization procedures > “Dynamic-air-removal 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 minutes >...
- Page 31 Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L* steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)), the Systec VE-150* steam sterilizer (Systec) and the CertoClav MultiControl MC2-S09S273** steam sterilizer (CertoClav GmbH, Traun).
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Page 32: Storage
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. -
Page 33: Servicing
6. Servicing Repairs and returns In the event of operating 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 been completely processed before returning it. -
Page 34: W&H Accessories And Spare Parts
7. W&H Accessories and spare parts 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-400 (6 pcs) 02038200 Spray adaptor... -
Page 35: Technical Data
8. Technical data Endea Endo Cursor EB-62 Transmission ratio Motor coupling in accordance with standard ISO 3964 Recommended root canal instruments* Root canal hand instruments Grip diameter (mm) Ø 3.6 – 4 min. chuck length (mm) until limit stop max. motor speed (rpm) 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. - Page 36 Technical data Endo NiTi WD-73 M WD-74 M Transmission ratio 70:1 128:1 Coupling in accordance with standard ISO 3964 Recommended root canal instruments* NiTi-Feilen for rotation root canal preparation Instrument shaft diameter according to standard ISO 1797 (mm) Ø 2.35 min.
- Page 37 Technical data Endea EB-75 EB-77 EB-79 Transmission ratio 16:1 Coupling ISO 3964 Recommended root canal instruments* NiTi-files for rotation root canal preparation Instrument shaft diameter according to standard ISO 1797 (mm) Ø 2.35 min. chuck length (mm) engaging max. motor speed for NiTi files from 300-350 rpm: 5,000 1,200 produces an application speed of:...
- Page 38 Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Temperature of the medical device on the patient side: maximum 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 and transport 8% to 80% (relativ), non-condensing...
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Page 39: Disposal
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... -
Page 40: Explanation Of Warranty Terms
Explanation of warranty terms This W&H medical device 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. -
Page 41: Authorized W&H Service Partner
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. - Page 42 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50669 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 005 / 24.08.2021 office@wh.com wh.com Subject to alterations...