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

Motor system for surgery
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Instructions for use
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HighSurg 30
Motor System for Surgery

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Summary of Contents for Nouvag HighSurg 30

  • Page 1 Instructions for use HighSurg 30 Motor System for Surgery...
  • Page 2 Instructions for use HighSurg 30 • 31666 • V20221117...
  • Page 3 Vorwort Herzlichen Glückwunsch zum Kauf eines Produktes der Firma NOUVAG AG. Wir freuen uns, dass Sie sich für ein NOUVAG Erzeugnis entschieden haben und danken Ihnen für Ihr entgegengebrachtes Vertrauen. Diese Bedienungsanleitung wird Sie mit dem Gerät und seinen Eigenschaften vertraut machen, damit eine möglichst lange und problemlose Funktion gewährleistet werden kann.
  • Page 4 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 5: Table Of Contents

    Electronic motor 21 Maintenance Replacing the control unit fuse Safety inspections (STI) Malfunctions and troubleshooting Spare parts list with order numbers Information on disposal HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 6: Product Description

    Saws as well as by straight and angled Shaver Handpieces (Micro Debriders). The patient group is not limited by age, weight, or gender. The setting up and operation of the HighSurg 30 must be carried out by the physician or by a qualified especially trained medical personnel.

  • Page 7: Ambient Conditions

    800 – 1060 hPa Warranty coverage Purchasing the HighSurg 30 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 8: Explanation Of Symbols

    European authorized representative Distributor Dangerous good! Warning! Extremely flammable Dangerous goods Aerosol spray: “Lubrifluid” Aerosol spray: “Lubrifluid” Medical device Environmentally hazardous Aerosol spray: “Lubrifluid” Biohazard HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 9: Safety Information

    Every use of the HighSurg 30 different to the product description defined in chapter 1.1, “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 10: Modification And Misuse

    Modification and misuse • If modifications to the HighSurg 30 and accessories are made by the user/operator or a third party, or if these items are used by these individuals for a purpose other than that for which the items were designed for (according to chapter 1.1 Intended use and operation), the manufacturer assumes no...

  • Page 11: Scope Of Delivery

    Lubricant spray “Lubrifluid”, including spray nozzle (Blue) --------------------------------------------------- 1 Optional: 2098nou Electronic motor 21 High Speed, 3 m motor cable, max. speed 80,000 rpm ------------------------------ 1 HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 12: Device Overview

    12. Release key for tubing set bracket for the lubrification of handpieces and contra-angles 13. Peristaltic pump 14. Tubing set 15. Stand for irrigation fluid bottle Rear view HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 13: Startup

    Device and accessories setup ● Installation layout ● 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 – please see section 3.1 and the manufacturer’s EMC declaration in the appendix of this manual.

  • Page 14: Device Preparation

    Do not regulate the amount of irrigation fluid using the roller clamp on the tubing set; with the HighSurg 30, 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 15 Open the bleed valve beneath the drip chamber. Connect the control unit to the power socket. Ensure that the operating voltage setting corresponds to the local mains voltage. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 16: Assembly Of External Irrigation System

    REF 1881 B) Connect the tube set with the external cooling tube of the Instrument (Example: Shaver blade). C) Secure clips to the handpiece. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 17: Operation

    By pressing both “Pump” keys at the same time “Pump ▲ + ▼” the pump will be put on call, pressing again will switch it off. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 18: 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. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 19: Adjusting The Programs

    Handpiece, 1:1 1: 1 80,000 fix 3 Jacobs Chuck Jacobs Chuck 2600 fix 35 Perforator Perforator 1200 max. Craniotome Craniotome 1000 60,000 fix 3 HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 20: Step 2: Handpiece And Contra Angle Test

    7.4.2 Step 2: Handpiece and Contra Angle test 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 21: Step 3: Setting The Speed

    * 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. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 22: Step 5: Setting The Pump Supply Quantity

    The bar chart on the display regresses and the instrument speed increases again. Program memory 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 program place.

  • Page 23: Configuration Menu

    Exit from Configuration Menu: • To leave the Configuration Menu press “Enter” for 3 seconds, until a long tone is emitted. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...
  • Page 24 Osc.Shaver yes/no Handpiece existing/HP 11 Jacobs Chuck yes/no Handpiece existing/HP 12 Perforator yes/no Handpiece existing/HP 13 Craniotome yes/no Handpiece existing/HP 14 4: 1 yes/no HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...
  • Page 25 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. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...
  • Page 26 HighSurg 30 The HighSurg 30 can recognize the type of a plugged-in motor. This enables the adaption of the motors and their safe operation. Motor 21, 50,000 rpm Range Factory Definition default Motor 21, 50,000 rpm/Min. speed 300 – 5000 rpm 300 rpm Set the min.

  • Page 27: 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. ● Micro saws ● Dermatome HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 28: Functional Check

    HighSurg 30 Functional check Prior to HighSurg 30 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.

  • Page 29: Cleaning, Disinfection, And Sterilization

    Do not use tubing sets when packaging is already open or damaged! Do not use tubing sets when expiry date has passed. 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 material change in a manner that can result in failure of the system.

  • Page 30: Maintenance

    The STI (Safety technical inspection) for the HighSurg 30 shall be executed every 2 years by authorized experts. Results shall be documented.

  • Page 31: 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 “HighSurg 30 Error messages on the display”. HighSurg 30 Operating Instructions, REF 31666, V23/22...
  • Page 32 2, but motor, motor cable, motor plug or Control Unit is defective. Unknown motor 1/ a) Motor 2 is selected but wrong motor is a) Plug in correct motor. plugged in. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...
  • Page 33 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. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...

  • Page 34: Spare Parts List With Order Numbers

    Motors must be sterilized before disposal. Please observe currently valid national disposal regulations for infectious waste. Contaminated single-use tubing sets are subject to specific disposal requirements. Please observe currently valid national disposal regulations for infectious waste. HighSurg 30 Operating Instructions, REF 31666, V23/22 Instructions for use HighSurg 30 • 31666 • V20221117...
  • Page 35 Anhang Appendix Appendice Appendice Apéndice Apêndice...
  • Page 36 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 37 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 38 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 39 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 40 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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