Schlumbohm EndoPilot 2 Скачать руководство пользователя страница 1 | Manualshive

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EndoPilot Contra-Angle

User manual

Processing instruction

Schlumbohm

EN

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Содержание EndoPilot 2

Страница 1: ...609 2210 v04 12 05 2020 EndoPilot Contra Angle User manual Processing instruction Schlumbohm EN ...

Страница 2: ...user manual without prior notice On request the user manual can be provided in different languages This user manual has been prepared with the greatest possible care However as errors can never be fully excluded we would appreciate any information at any time so we can improve the documentation for you Please contact us directly in such an event Also should you have any further questions please do...

Страница 3: ... Storage 14 Accessories 14 Technical data 14 Temperature information 15 Ambient conditions 15 Disposal 15 Disposal of the contra angle 15 Disposal of the packaging material 15 Liability 16 Service 16 Introduction Customer satisfaction is our top priority The present device was developed manufactured and tested in line with all applicable legal and normative provisions For your safety and for the s...

Страница 4: ...recautions and the present instructions for use It may only be reprocessed and maintained by persons having undergone training on the prevention of infections self protection and protection of patients Improper use e g inadequate hygiene and improper maintenance non observance of the present instructions for use or the use of non authorised accessories and spare parts shall exempt us from any warr...

Страница 5: ...an or any other medical practitioner licensed by the law of the State in which he or she practices and who intends to use or order the use of this medical device First usage 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 6...

Страница 6: ...ngle has to be cleaned disinfected lubricate and sterilized See chapter 6 Hygiene and maintenance Product description Press button Handle sleeve Operation Assembly and removal Do not insert assemble or remove the contra angle while in operation 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...

Страница 7: ...lt in the root canal instrument loosening or the press button getting hot We recommend to use always a rubber dam 1 Insert the instrument until the stop position is reached a and turn it until it locks in place b 2 Check if the instrument is safely locked in place by pulling it in axial direction b 3 To remove the instrument press the press button Verify full engagement Test run Do not hold the me...

Страница 8: ...ents and disinfectants Read the notes follow the instructions and heed the warnings provided by the manufacturers of cleaning Agents and or disinfectants Use only detergents which are intended for cleaning and or disinfecting medical devices made of metal And plastic It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant Use disinfec...

Страница 9: ...ice 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 Ensure that all outlets are rinsed out Wipe the entire surface of the instrument with disinfectant Remove the root canal instrument Remove the contra angle from the motor Note that the disinfectant used dur...

Страница 10: ...ral times 2 Remove any liquid residues using oil free filtered compressed air Manual disinfection We recommend wiping down the contra angle 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 disinfectant Schülke Mayr GmbH Norderstedt Germany If this product is not availabl...

Страница 11: ... CD washer disinfector Miele Cie KG Gütersloh and the Dr Weigert neodisher MediClean forte cleaning agent Dr Weigert GmbH Co KG Hamburg Cleaning at 55 C 131 F 5 minutes Disinfection at 93 C 200 F 5 minutes Drying Ensure that the medical device is completely dry internally and externally after cleaning and disinfection Remove any liquid residues using oil free filtered compressed air Inspection Mai...

Страница 12: ...ontra angle in an automatic instrument maintenance device for example in the W H Assistina 301plus see instructions for use coming with the device After maintenance please place the contra angle in an upright position on a clean disposable cloth This way excessive oil may drip off so that it cannot get into the motor Testing after Lubrication 1 Hold the contra angle with the head pointing downward...

Страница 13: ...rogram selected must be suitable for the medical device Recommended sterilization procedure Fractionated pre vacuum process type B Gravity displacement process type N Sterilization time at least 30 minutes at 121 C 250 F or at least 3 minutes at 134 C 273 F Maximum sterilization temperature 135 C 275 F Evidence of the medical device s basic suitability for effective sterilization was provided by a...

Страница 14: ...n 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 Gear ratio 1 1 Motor coupling in compliance with standard ISO 3964 2016 Amm 2018 Recommended root canal instruments Shank diameter of the instruments Type 1 acc to ISO14457 2017 NiTi files for ...

Страница 15: ...mperature during operation 10 C to 35 C 50 F to 95 F Humidity during operation 5 to 80 relative non condensing Disposal Ensure that the parts are not contaminated on disposal Disposal of the contra angle Follow your local and national laws directives standards and guidelines for disposal Disposal of the packaging material The packaging materials were duly selected to allow an environmentally frien...

Страница 16: ...oduct are at the sender s expense Application errors exclude a warranty Schlumbohm does not warrant for wear and contamination of the handpieces and contra angles Schlumbohm declines all responsibility for any damage caused as a result of the clinical application of its products Irrespective of whether or not such use is associated with other medical devices e g pacemakers Service In case of opera...

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