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Summary of Contents for Storz TL400
- Page 1 Instructions for use Power LED Rubina...
- Page 2 08-2023 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.
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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 Indications .......................... - Page 4 Table of contents 6.1 Switching the light on and off ....................23 6.2 Manual light adjustment ......................23 6.3 Automatic light control ....................... 23 6.4 Changing the light mode ......................24 6.5 Settings ............................25 6.5.1 Service .......................... 25 6.5.2 Setting the language ..................... 25 6.5.3 Event protocol .......................
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Page 5: General Information
This instruction manual is valid for: NIR Fluorescence light sources Product name Item number Power LED Rubina TL400 1.4 General signs and symbols The signs and symbols used in this document have the following meaning: Practical tip This sign refers to useful and important information. -
Page 6: Description Of Warning Messages
General information Lists Numbered list – Unnumbered list, 1st level – 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
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near- infrared (NIR) fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard... -
Page 8: Safety And Warning
Observe the instruction manuals and interface specifications of the devices and components used in combination. Only make changes to the product if these changes are approved by KARL STORZ. Instructions for use • Power LED Rubina • 400WXD_EN_V1.0_08-2023_IFU_FDA... -
Page 9: Product Not Clean
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: Using The Product With An Argon Device
Safety and warning 3.12 Using the product with an Argon device If the product is used with an argon device, an insufficient power setting on the product can influence the argon device. This may present a risk to the patient due, for example, to the risk of gas embolism during argon coagulation. -
Page 12: Product Description
Product description 4 Product description 4.1 Product overview Power LED Rubina, front Standby button Light output point Touchscreen Power LED Rubina, rear KS HIVE connector Mains socket USB port Potential equalization connector External sync interface connector Footswitch connection Line fuse holder Instructions for use •... -
Page 13: Possible Combinations
Product description 4.2 Possible combinations It is recommended that the suitability of the products for the intended procedure be checked prior to use. Please note that the described products in this medium may not be available in all countries due to different regulatory requirements. -
Page 14: Symbols On The Product
EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives 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 product Symbol Meaning Follow the instructions for use. -
Page 15: Symbols On The Type Plate
EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. Prevention of pollution by electronic devices Separate collection of electrical and electronic devices. -
Page 16: Symbols On The User Interface
Product description 4.4.4 Symbols on the user interface Symbol Meaning Settings Cancel Confirm Scroll backwards Browse up Browse down Increase value Decrease value Footswitch Audio signal off Instructions for use • Power LED Rubina • 400WXD_EN_V1.0_08-2023_IFU_FDA... -
Page 17: Ambient Conditions
Product description Symbol Meaning Audio signal on Light on Light off 4.5 Ambient conditions Transport and storage conditions Temperature -10°C ... +60°C (14°F ... 140°F) Relative humidity 5 – 85% (non-condensing) Air pressure 600 – 1,080 hPa Operating conditions Temperature 0°C ... 40°C (50°F ... 104°F) Relative humidity 5 – 85% (non-condensing) Max. operating altitude 3,000 m Instructions for use •... -
Page 18: Preparation
Preparation 5 Preparation 5.1 Unpacking the product Carefully remove the product and accessories from the packaging. Check the delivery for missing items and possible damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. -
Page 19: Connecting The Product
Preparation 5.4 Connecting the product Connect the potential equalization cable. Connect the power cord. Push the power plug fully into the power socket. Insert the KS HIVE connecting cable into the socket until the plug audibly clicks into place. Instructions for use • Power LED Rubina • 400WXD_EN_V1.0_08-2023_IFU_FDA... -
Page 20: 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 21: Connecting The Footswitch
Preparation Connect the light cable by twisting the knurled screw on the endoscope screw base through a quarter turn. 5.6 Connecting the footswitch Insert the footswitch connecting cable fully into the socket. Instructions for use • Power LED Rubina • 400WXD_EN_V1.0_08-2023_IFU_FDA... -
Page 22: Putting The Product Into Operation
Preparation 5.7 Putting the product into operation Switch on the product using the Standby button. ð The start screen appears and the self-test is performed. ð After a successful self-test, the ready signal sounds and the light source is ready for use. ð... -
Page 23: Application
Application 6 Application 6.1 Switching the light on and off Tap the Light button to switch the light on and off: orange = on, white = off. 6.2 Manual light adjustment WARNING No visual contact! Risk of injury! Using the product outside the field of vision can cause injury to tissue and damage to accessories. Only activate the product under visual contact. -
Page 24: Changing The Light Mode
Application Tap the Manual button. Tap the Auto button. Tap the Light button to switch the light on. ð The light intensity is automatically controlled via the camera control unit. Tap the Manual button to deactivate the automatic light control. Switch on the automatic light control again via the camera control unit;... -
Page 25: Settings
Tap the Settings button. ð The Settings screen appears with the following sub-menus: 6.5.1 Service The service area is reserved for the service employees of KARL STORZ and is therefore password protected. The settings are described in the service manual. 6.5.2 Setting the language In the Settings screen, tap the Language sub-menu. -
Page 26: Event Protocol
Application Select the language and confirm with the Checkmark. ð The Settings screen appears. Cancel the selection with the Cross. Browse back through the screen with the Arrow. 6.5.3 Event protocol Alarms and information reports are saved in the event log at the time of occurrence. Each line contains the following event data: –... -
Page 27: Audio Settings
Application 6.5.5 Audio settings Tap on the Audio signal on and Audio signal off buttons to switch the acoustic signals on or off. ð The function is active when the button turns orange. ð When the audio signal is switched off, a crossed out bell appears in the screen header. Confirm the screen with the Checkmark or cancel it with the Cross. -
Page 28: Acoustic Information Signal
Application 6.7.2 Acoustic information signal The acoustic information signal is issued for as long as the signal conditions apply. However, at least one complete signal sequence sounds. Acoustic signals can be temporarily switched on or off in Settings and are are always active when the product is restarted. The pitch of the information signal is modulated at a frequency of 1.5 Hz by ±... -
Page 29: Maintenance, Servicing, Repairs, And Disposal
7 Maintenance, servicing, repairs, and disposal 7.1 Maintaining the product 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. 7.1.1 Maintenance The following maintenance intervals are recommended:... -
Page 30: 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 Rubina • 400WXD_EN_V1.0_08-2023_IFU_FDA... -
Page 31: 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 32: 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 Three-way adaptor for light source TL005 Power cord, length 300 cm 400A Power cord, US version, 200 cm 400B One-pedal footswitch, one-stage UF101 OR1 patch cable CAT6a 2.0 m UL... -
Page 33: Electromagnetic Compatibility
Electromagnetic compatibility 9 Electromagnetic compatibility 9.1 General notes on the operating 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 34 Electromagnetic compatibility WARNING Reduced immunity or increased emissions! Malfunction! Use of the product with accessories, transducers and cables other than those specified in this manual may result in increased emissions or decreased immunity. Only use the accessories specified in the manual. WARNING Degradation of performance! Malfunction! Portable RF communications equipment (including peripherals such as antenna cables and external...
- Page 35 Electromagnetic compatibility Immunity tests EN/IEC 60601-1-2 Compliance level Electromagnetic test level environment – guidance 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. equipment further from sources to IEC 61000-4-8 of power frequency magnetic fields or to install magnetic...
- Page 36 Electromagnetic compatibility Test frequency Frequency Radio service Modulation Immunity Compliance band test level level 800 – 960 GSM 800/900, Pulse modula- TETRA 800, tion iDEN 820, 18 Hz CDMA 850, LTE band 5 1720 1700 – 1990 GSM 1800, Pulse modula- CDMA 1900, tion 1845...
- Page 37 Electromagnetic compatibility Immunity tests EN/IEC 60601-1-2 test Compliance Electromagnetic environ- level level ment – guidelines transmitter manufacturer and d is the recommended sepa- ration distance in meters [m]. Field strengths from fixed HF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each...
- Page 38 Electromagnetic compatibility Interference emission measure- Compliance Electromagnetic environment – ments guidelines Voltage fluctuations/flicker emissions Complies low voltage power supply network that acc. to IEC 61000-3-3 supplies buildings used for domestic purposes. 9.7 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product The product is intended for use in an electromagnetic environment in which HF disturbances are controlled.
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Page 39: Errors And Messages
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 40: 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 41: 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 42 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 43 Subsidiaries Instructions for use • Power LED Rubina • 400WXD_EN_V1.0_08-2023_IFU_FDA...
- Page 44 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...