Storz POWER LED 175 Instructions For Use Manual
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Storz POWER LED 175 Instructions For Use Manual

Storz POWER LED 175 Instructions For Use Manual

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Instructions for use
POWER LED 175

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Summary of Contents for Storz POWER LED 175

  • Page 1 Instructions for use POWER LED 175...
  • 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

    Table of contents Table of contents 1 General information  ......................... 1.1 Read the instructions for use  ..................... 1.2 Read the instructions for use of compatible products ............... 1.3 Scope ............................1.4 General signs and symbols ......................1.5 Description of warning messages ....................2 Normal use ............................2.1 Intended use ...
  • Page 4 Table of contents 5.7 Putting the product into operation  ..................... 20 6 Application  ............................21 6.1 Activating the most recent setting  ..................... 21 6.2 Setting the brightness  ........................ 21 6.3 Activating the lowest setting  ...................... 22 6.4 Switching off the product ......................22 7 Maintenance, servicing, repairs, and disposal ...

  • Page 5: General Information

    General information 1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use carefully and follow all the safety notes and warnings. Read the reprocessing instructions carefully and follow all the safety notes and warnings.

  • Page 6: Description Of Warning Messages

    General information – Unnumbered list, 2nd level 1.5 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warnings use the following levels of danger: WARNING WARNING Designates a possible imminent risk.

  • Page 7: Normal Use

    Positioning on a level, vibration-free surface Mobility Can be moved if placed on a cart. Combination Can be used on the patient at the same time as other devices. Control Can be controlled via the KARL STORZ SCB. Instructions for use • POWER LED 175 • TRZ380_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 8: Safety And Warning

    Safety and warning 3 Safety and warning WARNING Danger due to non-observance of warnings and safety notes This chapter contains warnings and safety notes structured according to hazards and risks. Carefully read and observe all warnings and safety notes. Follow the instructions. 3.1 Serious incidents A ‘serious incident’...

  • 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

    Safety and warning When using explosive narcotic gases: Operate the product outside of the hazard zone. Do not use the product in the presence of flammable anesthetics. The product must not be operated in oxygenated environments. Only connect or disconnect the power plug to or from the power supply outside explosive atmospheres.

  • Page 11: Observing Ambient Conditions

    Safety and warning 3.13 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 •...

  • Page 12: Product Description

    Product description 4 Product description 4.1 Product overview  POWER LED 175 – Front view Power switch LED display for current light intensity SCB indicator display* Standby button Button to reduce/increase brightness Light outlet point * If an SCB system can manage several light sources and multiple POWER LED 175 light sources are available simultaneously, the SCB system assigns each light source its own number.

  • Page 13: Possible Combinations

    Only KARL STORZ Hopkins telescopes are recommended in combination with KARL STORZ light cables. 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: –...

  • Page 14: Technical Data

    Product description 4.3 Technical data Description Value Power supply (AC) 100 – 240 V (±10%) Operating frequency 50/60 Hz Line fuse 2 x T 1.6 AH 250 V Power input 1.1 A Electrical protection class Applied part type according to IEC 60601-1 Dimensions (L x H x W) 233 x 110 x 305 mm Weight 4.6 kg 4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol...

  • Page 15: Symbols On The Type Plate

    EU regulations. A code number after the CE mark indicates the responsible notified body. 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...

  • Page 16: Symbols On The Product

    Symbol Meaning Follow the instructions for use. The color may differ on the product. The symbol is black/white on the packag- ing label. KARL STORZ SCB interface Remote control of functions and remote display of parameters Brightness Lamp/light source Ready/standby button...

  • Page 17: Preparation

    Preparation 5 Preparation 5.1 Unpacking the product Carefully remove the product and accessories from the packaging. Check the delivery for possible damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. Keep packaging for further transport.

  • Page 18: Connecting The Product

    Connect the power cord. Push the power plug fully into the power socket. Connect the SCB cable. Connect the other end of the SCB cable to a KARL STORZ control device or other SCB devices; see the instruction manual for the KARL STORZ SCB control NEO system.

  • Page 19: Connecting The Light Cable

    The light outlet point is provided with an antiglare flap, which does not allow any direct outlet of light. Light only appears when the light cable is attached. We recommend using original KARL STORZ light cables, because light cables from other manufacturers may not be optimized for light transmission.

  • Page 20: Putting The Product Into Operation

    Preparation 5.7 Putting the product into operation Monitor the product as it is starting up for signs of any button or display faults. Switch the product on with the power switch. ð On successful completion of the self-test, a short signal sounds and the product starts up in standby mode.

  • Page 21: Application

    Application 6 Application 6.1 Activating the most recent setting Press the standby button to activate the most recent light intensity setting. ð The LED integrated in the standby button goes out. 6.2 Setting the brightness Press the plus or minus button to increase or reduce the brightness. ð...

  • Page 22: Activating The Lowest Setting

    Application 6.3 Activating the lowest setting Press the standby button to activate the lowest light intensity. ð The LED integrated in the standby button lights up. 6.4 Switching off the product Switch the product off with the power switch. Instructions for use • POWER LED 175 • TRZ380_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 23: Maintenance, Servicing, Repairs, And Disposal

    Patients, users and third parties may be injured as a result of product and accessory degradation. Shut down the product. Have the deficiencies repaired by persons authorized by KARL STORZ. If they are not described in more detail here, maintenance activities may only be performed by KARL STORZ or by a company authorized by KARL STORZ.

  • Page 24: Safety Inspection In Accordance With Iec 62353

    Risk of injury due to product degradation! Patients, users and third parties may be injured as a result of product and accessory degradation. Shut down the product. Have the deficiencies repaired by persons authorized by KARL STORZ. Instructions for use • POWER LED 175 • TRZ380_EN_V2.0_05-2024_IFU_CE-MDR...

  • Page 25: Visual Inspection

    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 26: Accessories And Spare Parts

    Accessories and spare parts 8 Accessories and spare parts 8.1 Accessories Article Order no. All KARL STORZ light cables 495xx SCB Connecting Cable, 100 cm 20090170 Power cord, length 300 cm 400A Power cord, US version, 200 cm 400B Not all articles are available in all regions.

  • Page 27: Electromagnetic Compatibility

    Electromagnetic compatibility 9 Electromagnetic compatibility 9.1 General notes on the operating environment Special environment The product is suitable for use in close proximity to an active HF electrosurgical device in professional healthcare facility environments. Professional healthcare facility includes physician offices, dental offices, limited care facilities, freestanding surgical centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms, intensive care, surgical rooms, outside the RF shielded room of an ME system for MRT).

  • Page 28: Test-Tables

    Electromagnetic compatibility WARNING Degradation of performance! Malfunction! Portable RF communications equipment (including peripherals such as antenna cables and external antennas) could result in degradation of the performance of the product. Use portable communications equipment no closer than 30 cm (12 inches) to any part of the product, including cables.
  • Page 29 Electromagnetic compatibility Interference immu- EN/IEC 60601-1-2 Compliance level Electromagnetic nity tests test level environment – guidance 100% for 100% for 250/300 cycles 250/300 cycles Magnetic field at the 30 A/m 30 A/m If image distortion occurs, it may supply frequency at 50 Hz/60 Hz at 50 Hz/60 Hz be necessary to position the (50 Hz/60 Hz) acc.
  • Page 30 Electromagnetic compatibility 9.3.2 Table 2 – Test levels for proximity fields from RF wireless communications equipment Test fre- Frequency Radio service Modulation Immunity test Compliance quency band level level 380–390 TETRA 400 Pulse modula- tion 18 Hz 430–470 GMRS 460, ± 5 kHz FRS 460 deviation 1 kHz sine wave...
  • Page 31 Electromagnetic compatibility Interference emission measure- Conformity Electromagnetic environment – Guide- ments lines RF emissions according to Group 1 The product uses RF energy for its inter- CISPR 11 nal function only. Therefore, its RF emis- sions are very low and are not likely to cause any interference affecting nearby electronic equipment.

  • Page 32: Errors And Messages

    Possible causes Actions Constant tone after switching Hardware problem Send product to on and dark light intensity dis- KARL STORZ for repair play Overheating Switch off the product and let it cool down Warning signal (2 short beeps) Overheating, critical tempera- The product remains in opera- sounds every 15 seconds and...
  • Page 33 Power supply unit or LED defec- Send product to tive KARL STORZ for repair Insufficient light Soiled end faces of the light ca- Clean the end faces of the ble or the endoscope light cable and the light...

  • Page 34: Overview Of Mitigating Warnings

    Overview of mitigating warnings 11 Overview of mitigating warnings The original English warning text is as follows: To avoid the risk of electric shock, this equipment must only be connected to a sup- ply mains with protective earth. WARNING Portable RF communications equipment (including peripherals such as antenna ca- bles and external antennas) should be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified by the man- ufacturer.

  • Page 35: Subsidiaries

    KARL STORZ Endoscopy-America, Inc. E-Mail: info-be@karlstorz.com 2151 East Grand Avenue, El Segundo, CA 90245-5017, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 424 218-8100, Fax: +1 424 218-8525 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Toll free phone: 800 421-0837 (USA only) Téléphone: +33 1 30484200, Fax: +33 1 30484201...
  • Page 36 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 37 Subsidiaries Instructions for use • POWER LED 175 • TRZ380_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 38 Subsidiaries Instructions for use • POWER LED 175 • TRZ380_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 39 Subsidiaries Instructions for use • POWER LED 175 • TRZ380_EN_V2.0_05-2024_IFU_CE-MDR...
  • Page 40 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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