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Summary of Contents for Schlumbohm EndoPilot Contra-Angle
- Page 1 EndoPilot Contra-Angle User manual Processing instruction Schlumbohm...
- Page 2 Pilot² Manufacturer information: Schlumbohm GmbH & Co. KG Phone: +49 (0) 4324 - 8929 - 0 Klein Floyen 8-10 Telefax: +49 (0) 4324 - 8929 - 29 D-24616 Brokstedt post@schlumbohm.de Germany www.schlumbohm.de WEEE reg. no.: DE 88116129 The manufacturer reserves the right to change the information and data contained in this user manual without prior notice.
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Page 3: Table Of Contents
Pilot² Table of contents Page Introduction ...................... 3 Symbols used ....................4 First usage – Safety notes ................5 Product description................... 6 Operation ......................6 Assembly and removal ..................6 Changing of the root canal instruments ............7 Test run ......................7 Hygiene and maintenance ................... -
Page 4: Symbols Used
ISO 15223-1:2016 / Ref. 5.5.4 For example: Warning, risk of injuri Attention! (to prevent damages occurring) Thermo washer, disinfectable Steam sterilization up to he stated temperature General explanations © Schlumbohm GmbH & Co. KG... -
Page 5: First Usage - Safety Notes
Pilot² Catalogue Number Indicates catalogue number, part number of device ISO 15223-1:2016 / Ref. 5.1.6 Serial Number Serial number so the device can be identified ISO 15223-1:2016 / Ref. 5.1.7 Waste Collection Separate collection for waste of electrical and electronic equipment. EN 50419 - Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC Do not dispose of with domestic waste Data Matrix Code for product information... -
Page 6: Product Description
1. Connect the contra-angle to the motor until it snaps into place 2. Check if the contra-angle is tightly fastened to the motor 3. Remove the contra-angle by pulling it in axial direction Schlumbohm © GmbH & Co. KG... -
Page 7: Changing Of The Root Canal Instruments
1. Insert the root canal instrument. Start the contra-angle on the motor. In case of operating malfunctions (for example vibrations, unusual noise, overheating), please make sure to put the contra-angle out of operation immediately and contact the Schlumbohm ® customer service (see chapter 11). -
Page 8: Hygiene And Maintenance
The user is responsible for validating its process if the specified cleaning agents and disinfectants are not available. 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. Schlumbohm © GmbH & Co. KG... -
Page 9: Initial Treatment At The Point Of Use
Pilot² Send worn or damaged contra-angles or contra-angles with material changes to the Schlumbohm ® customer service. Processing cycles: We recommend a regular service for the contra-angle after 1000 processing cycles or one year. Initial treatment at the point of use •... -
Page 10: Manual Cleaning
»mikrozid® AF wipes« disinfectant (Schülke & Mayr GmbH, Norderstedt, Germany). If this product is not available, »CaviWipes®« dis- infectant (Metrex LLC, Orange, CA 92867 USA) is an alternative. © Schlumbohm GmbH & Co. KG... -
Page 11: Automated Cleaning And Disinfection
Pilot² Automated cleaning and disinfection We recommend 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 12: Lubrication
To do so, please start the calibration function of the EndoPilot. In case of dirt leaking from the contra-angle, the entire hygiene and maintenance procedure must be repeated. 3. Wipe the contra-angle with disinfectant wipes. © Schlumbohm GmbH & Co. KG... -
Page 13: Packaging
Pilot² Packaging Pack the contra-angle 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. (For the US: The package must follow the FDA requirements) The sterilization package must be large enough for the sterilization goods. -
Page 14: Storage
* By choosing the right conditions of operation, the user has to make sure to exclude any hazard to the user, patient or third persons. Please observe the instructions of the root canal instrument manufacturer (in terms of speed, torque and type of movement)) © Schlumbohm GmbH & Co. KG... -
Page 15: Temperature Information
Pilot² 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 (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 transport: 8% to 80% (relative), non-... -
Page 16: Liability
The customer service will give further instructions. Normally you will be asked to return the contra-angle. The costs of returning the product are at the sender’s expense. Application errors exclude a warranty. Schlumbohm does not warrant for wear and ®...
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