Nouvag HighSurg 30 Instructions For Use Manual
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Nouvag HighSurg 30 Instructions For Use Manual

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Instructions for use
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HighSurg 30

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Summary of Contents for Nouvag HighSurg 30

  • Page 1 Instructions for use HighSurg 30...
  • Page 2 INSTRUCTIONS FOR USE CONGRATULATIONS ON YOUR PURCHASE OF A PRODUCT FROM NOUVAG. We are pleased that you have chosen a quality product from NOUVAG and thank you very much for the trust you have placed in us. These instructions for use will familiarize you with the device and its functions so that you can apply and use them correctly.

  • Page 3: Table Of Contents

    Electronic motor 21 MAINTENANCE Replacing the control unit fuse Safety inspections MALFUNCTIONS AND TROUBLESHOOTING ACCESSORIES AND SPARE PARTS Information on disposal TECHNICAL DATA WARRANTY AND SERVICE Post market surveillance Service points APPENDIX © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 4: Intended Purpose

    INTENDED PURPOSE MEDICAL INDICATIONS The HighSurg 30 is a control unit which is used in combination with an electronic motor, handpieces, sterile single use tubing set (independent medical devices) to perform surgery in the following medical indications: // Plastic Surgery...

  • Page 5: Safety Information

    The use of the devices outside of the intended purpose is prohibited. Non intended modifications to the control unit and accessories are not allowed. Use of third party‘s devices and accessories not indicated by NOUVAG is not allowed. Repairs must only be performed by authorized NOUVAG service centres.

  • Page 6: Scope Of Delivery

    Stand for irrigation fluid bottle 1170 Handpiece tray 19584 Spray adapter with thread, for lubricant spray (REF 2128) 31666 HighSurg 30 instructions for use OPTIONAL DESCRIPTION QUANTITY 2098nou Electronic motor 21, 80’000 rpm © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 7: Device Overview

    20 Potential equalization connection 21 Power plug socket 22 Main switch 23 Fuse compartment 24 Threaded spray adapter for the lubrication of the electronic motor (REF 19584) 25 Spray nozzle (blue) © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 8: Setup

    SETUP DEVICE AND ACCESSORIES SETUP ¬ Place the HighSurg 30 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 near other devices is prohibited due to EMC.

  • Page 9: Device Preparation

    Use only NOUVAG tube sets REF 6024 and REF 6025, otherwise the correct function cannot be guaranteed. Check the expiry date of the tubing set and ensure that the packaging is not damaged. Using non-sterile tubing sets can result in serious infection and, in extreme cases, can cause death.

  • Page 10: Assembly Of External Irrigation System

    ASSEMBLY OF EXTERNAL IRRIGATION SYSTEM Secure handpiece clips to the Connect the tube set with the Secure clips to the handpiece. irrigation tube. external cooling tube of the Instrument (Example: Shaver blade). © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 11: Operation

    «  » reduces the maximum supply quantity By pressing both « Pump  » and « Pump  » keys simultaneously, the pump will be put on call, pressing again will switch it off. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 12: Overview: Standard Display

    For handpieces with a selected speed greater than 50’000 rpm, the warning W34 appears for 1 second and the display lights up red. The user is reminded not to exceed the maximum speed of the handpiece. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 13: Adjusting The Programs

    1 : 1 80’000 fix 3 fix 3 Jacobs Chuck Jacobs Chuck 2600 fix 35 fix 35 Perforator Perforator 1200 fix 80 fix 80 Craniotome Craniotome 1’000 60’000 fix 3 fix 3 © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 14 STEP 2 TEST OF HANDPIECE AND CONTRA ANGLE To make sure the handpieces work in perfect condition, the HighSurg 30 can check them in a test run for their torque behavior. This is a simple procedure, which helps to detect disorders and defects in the handpieces at an early stage, to ensure safety during application to the patient.
  • Page 15 * The value before the slash refers to the use with the 50’000 rpm motor, the value after the slash to the 80’000 rpm motor. With the 80’000 rpm motor all the torques are fixed. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 16: Torque Limiter

    When switching the HighSurg 30 off, all the settings, made by the user are automatically stored in each program place. At switch off from the HighSurg 30 all the settings made by the user are automatically stored in each pro- gram place.

  • Page 17: Configuration Menu

    The setting returns to its previous value, without emitting a tone. EXIT FROM CONFIGURATION MENU To leave the Configuration Menu press « Enter » for 3 seconds, until a long tone is emitted. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 18 Because HP 04, 1:1 is permanently active, it’s not listed in this table. HP 15, OTO drill motor handpiece is also always activated and therefore does not appear on this list. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 19 Set the range where section 3 is active Pump switch mode on / off No / Yes No: Pump starts simultaneously with the handpiece drive. Yes: Pump starts separately by pressing the foot switch. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 20 HIGHSURG 30 INSTRUCTIONS FOR USE OPERATION The HighSurg 30 can recognize the type of plugged-in motor. This enables the adaption of the motors and their safe operation. SPEED RANGE FACTORY MOTOR 21 50’000 rpm DEFAULT DEFINITION Motor 21, 50’000 rpm / Min. speed 300 –...

  • Page 21: Operation Using The Vario Pedal

    For safety reasons, the unit can only be operated by pedal. The speed of the following handpieces is fixed and cannot be changed. © NOUVAG AG • 31666 • V20230324 • All rights  reserved ● Micro saws ● Dermatome...

  • Page 22: Functional Check

    By pressing the motor key again, the rotational direction is switched back to right rotation, which is shown on the display by the symbol of a changing arrow. PROGRAM The required program can be set by repeatedly pressing the button  P on the pedal. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 23: Cleaning And Disinfection

    Do not use tube set when packaging is already opened or damaged! Do not use tubing set if expired. Use only NOUVAG tubing sets with REF 6024 and REF 6025. Sterility cannot be guaranteed by reusing and re-sterilization of tubing sets. The characteristics of the mate- rial may change resulting in serious infections or, in worst case, the death of the patient.

  • Page 24: Maintenance

    Results shall be documented. The service manual, wiring diagrams, and descriptions are available upon request from the manufacturer. NOUVAG offers a safety inspection service for its customers. Addresses can be found in the appendix of this instructions for use under .

  • Page 25: Malfunctions And Troubleshooting

    [ Service points > 30 ] tions for use under If the display is illuminated red by an error warning, the error code can be found under [ Error-messages on Display > 26 ] © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 26 Plug in correct motor. plugged in. Right motor is connected to motor socket Send motor and control unit to Service 2, but motor, motor cable, motor plug or Center. control unit defective. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 27 NOU-dongle was plugged in. 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. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 28: Accessories And Spare Parts

    When disposing of the device, device components and accessories, the requirements specified in legislation must be followed. To ensure environmental protection, old devices can be returned to the dealer or manufac- turer. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 29: Technical Data

    300 – 50’000 rpm Speed 300 – 80’000 rpm Torque max. 7,5 Ncm Torque max. 4 Ncm Weight 340 g Weight 340 g Cable length 2,9 m Cable length 2,9 m © NOUVAG AG • 31666 • V20230324 • All rights  reserved...

  • Page 30: Warranty And Service

    6 months, wear parts are excluded from the warranty. During this warranty period, NOUVAG agrees to either repair or replace the product at its option if the product fails to function properly under normal use and service and such failure is due solely to a defect in workmanship or materials.

  • Page 31: Appendix

    Electromagnetic compatibility (EMC) Remark: The Product subsequently referred to herein always denotes the HighSurg 30. 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 32 Product should b observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Product. over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 33 At 80 MHz and 800 MHz, the separation distance fort the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 34 HIGHSURG 30 INSTRUCTIONS FOR USE © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 35 INSTRUCTIONS FOR USE HIGHSURG 30 © NOUVAG AG • 31666 • V20230324 • All rights  reserved...
  • Page 36 NOUVAG AG NOUVAG GmbH St. Gallerstrasse 25 Schulthaissstrasse 15 9403 Goldach 78462 Konstanz Switzerland Germany Phone +41 71 846 66 00 Phone +49 7531 1290 - 0 info@nouvag.com info-de@nouvag.com www.nouvag.com www.nouvag.com © NOUVAG AG • 31666 • V20230324 • All rights reserved...

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