Nouvag MD 11 Instructions For Use Manual

Nouvag MD 11 Instructions For Use Manual

Motor system for implantology
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Instructions for use
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MD 11
Motor System for Implantology

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Summary of Contents for Nouvag MD 11

  • Page 1 Instructions for use MD 11 Motor System for Implantology...
  • Page 2 Instructions for use MD 11 • 31665 • V20220914...
  • Page 3: Table Of Contents

    Replacing the control unit fuse   Safety inspections (STI) 10  Malfunctions and troubleshooting 11  Spare parts list with order numbers 12  Information on disposal 28  MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 4: Product Description

    800 – 1060 hPa Warranty coverage Purchasing the MD 11 entitles you to a 1-year warranty. If you return the warranty card for registration within four weeks of the date of purchase, warranty coverage will be extended for a further 6 months.
  • Page 5: Explanation Of Symbols

    Indication of the pump flow direction Dangerous goods Aerosol spray: Dangerous goods Aerosol spray: Environmentally hazardous Extremely flammable NouvaClean/NouvaOil NouvaClean/NouvaOil Dangerous goods Aerosol spray: European authorized representative Warning NouvaClean/NouvaOil MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 6: Safety Information

    Every use of the MD 11 different to the product description defined in chapter “Intended use and operation”, causes risks for patients and trained personnel. If physical examinations and therapies are carried out without use of the devices then the devices must be removed from the place of treatment.
  • Page 7: Modification And Misuse

    The warranty will be canceled.  Use of the MD 11 outside the indications described in Section 1.1 is prohibited. The user or operator is solely responsible for any such use.
  • Page 8: Scope Of Delivery

    Spray adapter for NouvaOil-Spray for the care of electronic motors, handpieces and contra- angles -------------------------------------------------------------------------------------------------------------------- 1 31665 Information for use, MD 11 on CD-ROM ------------------------------------------------------------------------- 1 In line with regulations pertaining to hazardous materials, the following items are not delivered with the control unit and must be ordered separately:...
  • Page 9: Device Overview

    10. Release key for tubing set bracket 21. Fuse compartment 11. Display 22. Spray adapter for the lubrication of the electronic motor 12. Peristaltic pump Rear view MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 10: Startup

    Device setup • Installation layout • Place the MD 11 and all required accessories and instruments on an even, non-slip surface and make sure you have good access to all controls. • The installation of the device in close proximity to other devices is prohibited due to EMC – please see section 3.1 and the manufacturer’s EMC declaration in the appendix of this manual.
  • Page 11: Device Preparation

    It indicates the flow direction of the cooling liquid. Do not regulate the amount of irrigation fluid using the roller clamp on the tubing set; with the MD 11, this is regulated instead using the integrated pump. For this reason, make sure to open the roller clamp as far as it will go (please refer to 7.4.5 Setting the pump supply quantity).
  • Page 12: Assembly Of External Irrigation System

    Attach grey clip, connected with the tubing set, to the cable of the electronic motor. G) Ready to use drill unit with attached external cooling system. If required, secure additional clips to the motor cable. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 13: Assembly Of Internal And External Irrigation System (Optional)

    L) Tubing set routing with Y-connector for internal and external cooling of the instrument. Essential accessories for internal cooling: REF 1777 REF 1873 Y-connector Motor cable clips REF 1773 16 cm connection tubes MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 14: Operation

    By pressing both “Pump” keys at the same time “Pump ▲ + ▼” the pump will be put on call, pressing again  will switch it off. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 15: Overview: Standard Display

    Information line Information and error messages are displayed here. Display is illuminated red at error messages. At standby the display shows “Nouvag AG – MD 11 V2.0” with the note of the device history. Program Shows the selected program number 1 to 6. The factory setting is adjusted to 4 usable programs.
  • Page 16: Adjusting The Programs

    Menu (refer to “7.8 configuration menu/handpiece existing”). As a result by pressing the button «Handpiece» not all handpieces will be recalled, but only those that belong to the assortment. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 17: Step 2: Calibrating Handpiece Or Contra Angles

    At the calibration procedure, the handpieces are tested on their torque delivery behavior. With the 1:1 handpiece the control unit is additionally adjusted to altered conditions of the handpiece to keep it delivering the appropriate torque. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 18: Step 3: Setting The Speed

    To activate or deactivate the pump, press both “Pump” keys at the same time, “Pump ▲ + ▼”, or push the foot switch “PUMP” shortly. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 19: Torque Limit Function, Al Mode (Automatic Limiter)

    To rpm: Storing various programs With the MD 11, up to 6 different settings can be set as fixed program (program 1 to program 6). Which program is currently active is shown on the display. At switch-off, the settings made by user are automatically saved. This includes the following parameters: •...
  • Page 20: Configuration Menu

    Shows operating hours of motor 1 Operating hours/Pump read Shows operating hours of pump Error memory/ 1 – 8 read 8 Error messages in chronological order. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 21 10 % Adjustment steps in section 3 Pump/Range 3 end 20 – 100 % 100 % Set the range where section 3 is active. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 22 Menu to factory default. Exit from Configuration Menu • To leave the Configuration Menu press “HP” and “PR” for 3 sec., until you hear a long tone. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 23: Operation Using The Vario Pedal

    (speed as set on the control unit) (speed as set on the control unit) For safety reasons, the unit can only be operated by pedal. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 24: Functional Check

    7.10 Functional check Prior to MD 11 startup or use of accessory equipment, the user must always ensure that each individual component is in good working order, free from defects, and is clean, sterile and operational. All inscriptions on the device and its accessories must be readable and there must be no loose parts in the device. Once the device is switched on, the most recent settings entered appear on the display.
  • Page 25: Cleaning, Disinfection And Sterilization

    Electronic motor 21 The reprocessing instructions for the electronic motor 21 can be found in the instructions for use, supplied with the electronic motor. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 26: Maintenance

    The STI (Safety technical inspection) for the MD 11 shall be executed every 2 years by authorized experts. Results shall be documented.
  • Page 27: Malfunctions And Troubleshooting

    If the display is illuminated red by an error warning, the error code can be found on the next page in this user manual under “MD 11 Error messages on display”. MD 11, Operating Instructions, REF 31665, V07/21...
  • Page 28 Service Center. Handpiece XX is Ok! Tested handpiece is OK. Calibrating HPXX is Ok! Calibrated handpiece is OK. Testing the handpiece XX Handpiece is testing. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 29 The red highlighted error messages are also illuminated red on the control device display. The other messages are for information and do not require any action by the user. MD 11, Operating Instructions, REF 31665, V07/21 Instructions for use MD 11 • 31665 • V20220914...
  • Page 30: Spare Parts List With Order Numbers

    Operation manual MD 11 -------------------------------------------------------------------------------------------------------------- 31665 The operating instructions are supplied by Nouvag AG as a PDF file on CD-ROM, in each case together with the device. If you prefer a printed copy, we will send it to you by post free of charge. If the operating instructions can no longer be found, we will be happy to send you a new copy as a PDF file by email.
  • Page 31 Anhang Appendix Appendice Appendice Apéndice...
  • Page 32 Electromagnetic compatibility (EMC) Remark: The Product subsequently referred to herein always denotes the MD 11. Changes or modifications to this product not expressly approved by the manufacturer may result in increased emissions or decreased immunity performance of the product and could cause EMC issues with this or other equipment. This product is designed and tested to comply with applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows.
  • Page 33 IEC 61000-4-11 is recommended that the Product be powered 70 % U ; for 25/30 cycles 70 % U ; for 25/30 cycles from an uninterruptible power supply or a battery. 0 % U for 5 sec 0 % U for 5 sec Power frequency 30 A/m...
  • Page 34 Electromagnetic immunity against high-frequency wireless communication devices Test frequency Frequency Communication Modulation Maximum distance Test level band service Performance Pulse modulation 380 to 390 TETRA 400 18 Hz GMRS 460, 430 to 470 ± 5 kHz Hub FRS 460 1 kHz Sinus Pulse modulation 704 to 787 LTE Band 13, 17...
  • Page 35 Nouvag GmbH • Schulthaissstrasse 15 • DE-78462 Konstanz Phone +49 7531 1290 - 0 info-de@nouvag.com • www.nouvag.com A complete list of Nouvag certified service centers are found on the Nouvag website at: www.nouvag.com/service Post market surveillance In the event of problems with the product or in the event of a serious incident, please immediately download, compile and send the following form https://nouvag.com/media/attachments/2022/05/19/for_8-308.pdf...
  • Page 36 Nouvag AG • St.Gallerstrasse 25 • CH-9403 Goldach Tel. +41 71 846 66 00 info@nouvag.com • www.nouvag.com Nouvag GmbH • Schulthaissstrasse 15 • DE-78462 Konstanz Tel. +49 7531 1290 - 0 info-de@nouvag.com • www.nouvag.com...

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