Storz LED nova 150 Instructions For Use Manual
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Storz LED nova 150 Instructions For Use Manual

Storz LED nova 150 Instructions For Use Manual

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LED nova 150

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Summary of Contents for Storz LED nova 150

  • Page 1 Instructions for use LED nova 150...
  • Page 2 05-2024 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.

  • Page 3: Table Of Contents

    5.2 Inspecting products  ........................17 5.3 Reprocessing the product  ......................17 5.4 Setting up the product  ....................... 17 5.5 Connecting the product  ......................18 5.6 Connecting the light cable  ......................18 6 Application  ............................20 Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 4 Table 3 – Emission class and group  ................28 10 Errors and messages  ........................30 10.1 Product malfunctions  ......................... 30 11 Overview of mitigating warnings  ....................31 12 Subsidiaries  ............................32 Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 5: General Information

    ð Interim result of an action Step 2 ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1 Lists Numbered list – Unnumbered list, 1st level Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 6: Description Of Warning Messages

    Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.   NOTICE    NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 7: Normal Use

    The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.7 Patient population There are no restrictions in terms of patient groups for this product. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 8: Safety And Warning

    Only use devices and components that have standardized interfaces and do not breach the normal use of the product. Observe the instruction manuals and interface specifications of the devices and components used in combination. Do not make any modifications to the product. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 9: Working In The Field Of Vision

    Ensure that all electrical installations of the operation room in which the product is connected and used conform with the applicable IEC standards. Use either the power cord supplied by KARL STORZ or a power cord which has the same properties and which bears a national mark of conformity.

  • Page 10: Electromagnetic Interference

    Set the output of the adjustable light sources to a level that is just high enough to ensure optimal illumination of the operating area. 3.12 Failure of products The product may fail during use. Have a replacement product ready for each application or plan for an alternative surgical technique. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 11: Observing Ambient Conditions

    If the device is stored, transported, operated or reprocessed under unsuitable conditions, patients, users or third parties may be injured and the device can be damaged. Observe the ambient conditions listed in the instructions for use and reprocessing. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 12: Product Description

    Light cable with endoscope or videoendoscope Compatibility with light cables Series 495xx light cables are compatible with the standard adapter. Only KARL STORZ Hopkins telescopes are recommended in combination with KARL STORZ light cables. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 13: Technical Data

    Product description Compatibility with camera control units (CCU) The light source can be connected to the KARL STORZ camera control unit (CCU). The following camera control units (CCUs) can be combined: – IMAGE1 S CONNECT (TC200) – IMAGE1 S CONNECT II (TC201) – IMAGE1 S H3-LINK (TC300) –...

  • Page 14: Symbols On The Type Plate

    The EU regulations relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. 4.4.2 Symbols on the type plate Symbol Meaning Manufacturer Article no. Medical device Prevention of pollution by electronic devices Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 15: Symbols On The Product

    The potential equalization complies with the requirements for a medical electri- cal system. Applied part of the type CF 4.5 Ambient conditions Transport and storage conditions Temperature -18°C ... +60°C (-0.4°F ... +140°F) Relative humidity 5–85% (non-condensing) Air pressure 500−1,080 hPa Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 16 Product description Operating conditions Temperature 10°C ... 40°C (50°F ... 104°F) Relative humidity 20–85% (non-condensing) Max. operating altitude 3,000 m Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 17: Preparation

    Place the product on a horizontal, flat surface. Make sure that the power cord can be unplugged at any time. Keep the product out of reach of patients. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 18: Connecting The Product

    This can cause burns to users and third parties. Switch off the light source before changing the light cable. Allow the product to cool down before changing the light cable. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 19 Plug the light cable into the socket as far as it will go. Hold the light cable only by the handle, never by the cable. Connect the light cable by twisting the knurled screw on the endoscope screw base through a quarter turn. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 20: Application

    Turn the control clockwise or counter-clockwise to increase or decrease the brightness. Only use the product if the brightness level control is working properly. 6.3 Switching off the product Switch the product off with the power switch. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 21: Maintenance, Servicing, Repairs, And Disposal

    ü The product is switched off. ü The power cord is disconnected from the product. Use a screwdriver to remove the screw inserts on the line fuse holder. Remove the defective fuse. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 22: Safety Inspection In Accordance With Iec 62353

    7.3.1 Visual inspection Check the product and accessories for any mechanical damage. Check labels for readability. 7.3.2 Electric measurements Limit values for electrical measurements can be found in the current IEC 62353. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 23: Functional Test

    Document the results of the safety inspection. 7.4 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries).

  • Page 24: Accessories And Spare Parts

    Power cord, length 300 cm 400A Power cord, US version, 200 cm 400B Not all articles are available in all regions. 8.2 Spare parts Article Order no. Line fuse T 1.6 AH 250 V, pack of 10 1973290 Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 25: Electromagnetic Compatibility

    Preferably use the accessories specified in the manual. When using other than those specified in this manual, it becomes the responsibility of the user to determine compliance with IEC 60601-1-2. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 26: Test-Tables

    0.5 cycles @ 0°, 45°, ible power supply or a battery. 90°, 135°, 180°, 90°, 135°, 180°, 225°, 270°, and 315° 225°, 270°, and 315° phase angles phase angles Voltage interruption: Voltage interruption: Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 27 8 A/m @ 30 kHz 8 A/m @ 30 kHz close proximity, (CW modulation) (CW modulation) IEC 61000-4-39 65 A/m @ 134.2 kHz 65 A/m @ 134.2 kHz (pulse modulation) (pulse modulation) 7.5 A/m @ 13.56 kHz 7.5 A/m @ 13.56 kHz (pulse modulation) (pulse modulation) Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 28 Guidelines and manufacturer’s declaration – electromagnetic emissions The product is intended for use in such an environment as specified below. The customer or user of the device should ensure that it is used in such an environment. Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 29 Harmonic emissions acc. to Class A the public low voltage power supply net- IEC 61000-3-2 work that supplies buildings used for do- mestic purposes. Voltage fluctuations/flicker emis- Compliant sions acc. to IEC 61000-3-3 Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 30: Errors And Messages

    Light cable or endoscope de- Replace the light cable or fective endoscope LED service life has been ex- Send product to ceeded KARL STORZ for repair Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 31: Overview Of Mitigating Warnings

    WARNING No modification of this equipment is allowed. WARNING Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 32: Subsidiaries

    E-Mail: info-lt-lv@karlstorz.com Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Istanbul, Turkey Phone: +90 216 442 9500, Fax: +90 216 442 9030 **Sales for Industrial Endoscopy Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 33 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. E-Mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut, Lebanon...
  • Page 34 Subsidiaries Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 35 Subsidiaries Instructions for use • LED nova 150 • MTH786_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 36 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...

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