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Related Manuals for Storz TL410US
Summary of Contents for Storz TL410US
- Page 1 INSTRUCTION MANUAL TL410US Cold Light Fountain power LED saphira...
- Page 3 Thank you for your expression of confidence in the KARL STORZ brand name. Like all of our other products, this product is the result of years of experience and great care in manu facture. You and your organization have decided in favor of a modern, high-quality item of equipment from KARL STORZ.
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Page 4: Images Of The Device
Images of the device Images of the device... -
Page 5: Controls, Displays, Connectors, And Their Uses
‘Photodynamic Diagnosis’ from IEC 60601-2-75. However, for historical reasons, the term Photodynamic Diagnosis persists in the technical literature as well as in general usage as a synonym for FCI. In reference to TL410US, the established term PDD is therefore still used. -
Page 6: Symbols Employed
Symbols employed Symbols employed 3. 1 Symbols on the device Follow instructions for use Standby/ON/OFF Potential equalization connector Type CF applied part according to IEC 60601-1 Alternating current Fuse Ethernet Connection socket for footswitch Electronic information product pollution control (China RoHS) This device has been labelled in accordance with the European Directive on waste electrical and electronic equipment (WEEE). -
Page 7: Label And Packaging Symbols
Symbols employed 3. 2 Label and packaging symbols Manufacturer Catalogue number Serial number Number of products in the product packaging Keep dry Fragile, handle with care Consult instructions for use... -
Page 8: User Interface Symbols
Symbols employed 3. 3 User interface symbols White light Mode display for white light and PDD applications Footswitch (only shown if the footswitch is connected) Menu (only shown if the light source on stand-by) ON/OFF (white = Off) ... -
Page 9: Table Of Contents
Safety precautions at the site of installation ................. 12 5. 12 Safety features ..........................12 5. 12. 1 Self-test ............................12 6. KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System ......13 6. 1 Saphira Rigid PDD Cystoscope System..................13 7. Installation and operating instructions ................14 7. - Page 10 Contents 7. 4. 3 Using manual light intensity regulation ..................19 7. 4. 4 Changing the light mode......................20 7. 4. 5 Switching off the device (decommissioning) ................. 20 7. 5 Settings ............................21 7. 5. 1 Service ............................21 7.
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Page 11: General Information
PDD or blue light (Mode 2) mode for identification of fluorescent images. The Saphira Rigid PDD Cystoscope System is a subsystem of the KARL STORZ D-Light C PDD System. Refer to Chapter 6.1 Saphira Rigid PDD Cystoscope System for system configuration diagram. -
Page 12: Safety Instructions
Safety instructions Safety instructions Safety instructions are measures intended to protect the user and patients from the risks which could arise through the use of the system. 5. 1 Explanation of warnings and cautions Please read this manual and follow its instructions carefully. The words Warning, Caution, and Note convey special meanings. Wherever they are used in this manual, they should be carefully reviewed to ensure the safe and effective opera tion of this product. - Page 13 It should be noted that the local legal regulations have priority over the above‑mentioned requirements. If in doubt, contact your representative on site or the technical customer service. Use KARL STORZ model UG300 (included on UG130U Cor cart) or UG890 Isolation Transformer when configuring the IMAGE1 S Saphira TC205US, TC305US with the TL410US light source.
- Page 14 WARNING: Test this device prior to each surgical procedure to ensure that it is functioning correctly. It should not be used if any damage is evident. WARNING: The device may only be operated with the power cable delivered by KARL STORZ or a similar power cable which has a national inspection seal.
- Page 15 Safety instructions Warnings and cautions WARNING: The compatibility of this device with any accessories and/or energized endotherapy devices should be checked in the individual instructions for use. WARNING: The line voltage to the device is only definitively disconnected once the power plug has been unplugged. WARNING: The signal input and signal output parts of this device are designated by the manufacturer for exclusive connection to equipment which complies with IEC 60601‑1.
- Page 16 WARNING: The KARL STORZ D‑Light C PDD System is restricted to use only by physicians who have completed appropriate training in cystoscopy, and who have been trained in the use of the KARL STORZ D‑Light C PDD System and the optical imaging agent Cysview ®...
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Page 17: Normal Use
5. 2 Normal use It is only allowed to use the power LED saphira light source in combination with approved accessories from KARL STORZ or with equipment that is approved as safety-related uncritical. Use of the device in fields other than those indicated above is not allowed for safety reasons. -
Page 18: User Qualification
Only qualified doctors and medical assistant staffs are allowed to use the cold light fountain power LED saphira light source after training. Training should only be provided by persons equipped to do so on the basis of their skills. Your local representative or responsible KARL STORZ sales representative is available to provide training on your premises and to give you information about further training options. -
Page 19: Intended Conditions Of Use
Safety instructions 5. 9 Intended conditions of use 5. 9. 1 Use The device is intended for use in hospitals and doctors’ offices. The technical data and ambient conditions are described in the instruction manual. It is the user’s responsibility to make sure the device is safe and operates properly before using it. During treatment using the power LED saphira cold light fountain, the patient must be treated and kept under observation with the usual medical care. -
Page 20: Safety Precautions At The Site Of Installation
Safety instructions 5. 11 Safety precautions at the site of installation The device may only be used in medical rooms in which the electrical equipment has been installed in accordance with applicable national regulations. It is not intended for use in hazardous zones. WARNING: The device is not intended for use in potentially explosive zones. -
Page 21: Karl Storz D-Light C Photodynamic Diagnostic (Pdd) System
KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System 6. 1 Saphira Rigid PDD Cystoscope System Monitor NOTE: This is the only valid configuration. Light Source TL410US Camera Control Unit TC205US / TC305US Camera Head Fiber Light Cable TH113US 495NAC Rigid PDD Cystoscope 27005AIA/FIA/BIA/CIA... -
Page 22: Installation And Operating Instructions
If possible, retain the original packing materials for later use; these can come in handy if the device has to be transported. 7. 2 Basic equipment KARL STORZ Set No.: TL410US 1 power LED saphira cold light fountain 1 400B power cord, length 300 cm 1 Instruction manual 96286016US 1 Patch cable CAT6a, 2.0 m, UL, WO10275... -
Page 23: Connecting The Ground Line
Installation and operating instructions 7. 3. 1 Connecting the ground line WARNING: The device is equipped with a connector for attaching a ground line. Carry out potential equalization as per the applicable national regulations. The device is equipped with a connector 5 for attaching a ground line. The device’s ground line should be installed by a qualified electrician (Fig. -
Page 24: Connecting Light Cable
7. 3. 5 Connecting the light cable to the endoscope Connect the light cable to the endoscope (Fig. 6). NOTE: The use of original KARL STORZ light cables only is recommended. Light cables from other manufacturers may not be optimally adjusted for light transmission. -
Page 25: Connecting The Footswitch
Installation and operating instructions 7. 3. 6 Connecting the footswitch Connect the cable from the footswitch to its mating connector 4 (Fig. 7). General applications The power LED saphira is suitable for use in a wide range of applications. The correct light intensity depends on the particular application, the instrument being used, and the connected light cable. -
Page 26: Switching The Light On And Off
Once the device has been switched on, the first thing that is displayed on the screen is the KARL STORZ logo (Fig. 9). The device is now running a self test. Once the test has successfully completed, an acoustic availability signal sounds and the light source is ready for use. -
Page 27: Using The Automatic Light Source Control
Installation and operating instructions 7. 4. 2 Using the automatic light source control If the power LED saphira is connected to the camera control unit IMAGE1 S via KS HIVE cable, automatic light intensity regulation can be used. Prerequisite: IMAGE1 S with software release version 4.2 as a minimum Press the button ... -
Page 28: Changing The Light Mode
Installation and operating instructions 7. 4. 4 Changing the light mode For decommissioning, switch off the unit at the power switch. The light mode (white light and PDD applications) can only be changed using the buttons of a compatible camera head connected to the IMAGE1 S, via the IMAGE1 S (see IMAGE1 S instruction manual) or with a footswitch connected to the light source. -
Page 29: Settings
Installation and operating instructions 7. 5 Settings Click on the menu icon to call up the Settings menu (Fig. 16). NOTE: The setting menu symbol is only visible and the setting menu can only be called up if the light source is in stand‑by (symbol on the ON/OFF button ... -
Page 30: Event Protocol
Installation and operating instructions 7. 5. 3 Event protocol The corresponding window is opened by pressing the ‘Event protocol’ button in the Settings menu (Fig. 17). The Event protocol contains the saved information and alarms. Each entry occupies one row and consists of date, time and alarm/ information ID. Scroll if necessary using the arrow buttons (... -
Page 31: Maintenance
Maintenance Maintenance 8. 1 Fuse replacement WARNING: The line voltage to the device is only definitively disconnected once the power plug has been unplugged. Switch off the device and remove the power plug from the electrical outlet (Fig. 23). Remove the fuse holder 8 with a screwdriver or other suitable tool (Fig. 24). WARNING: Only use fuses of the correct rating. -
Page 32: Reprocessing
Maintenance 8. 2 Reprocessing 8. 2. 1 General warnings for medical devices WARNING: Risk of infection: Incorrectly reprocessed medical devices expose patients, users and third parties to a risk of infection as well as the risk that the medical device may malfunction. WARNING: When carrying out any work on contaminated medical devices, the guidelines of the Employers’... -
Page 33: Maintenance And Safety Check
Maintenance 8. 3 Maintenance and safety check WARNING: Always unplug the unit and disconnect the endoscope before carrying out any maintenance or cleaning. 8. 3. 1 Maintenance Preventive maintenance is not essential. Regular maintenance can, however, contribute to identifying potential problems before they become serious, thus enhancing the instrument’s reliability and extending its useful service life. -
Page 34: Servicing And Repair
WARNING: At the end of its useful operating life, dispose of the device as electronic scrap. Please ask either KARL STORZ SE & Co. KG, a KARL STORZ subsidiary or your specialist dealer for information on your local collection point. -
Page 35: Limitation Of Liability
8. 8 Limitation of liability KARL STORZ shall be liable for the safe operation, op erational reliability, and performance of this equipment only subject to the following conditions: • all assembly operations, system expansions, readjustments, modifications, or repairs have been performed by a person or persons duly authorized by KARL STORZ;... -
Page 36: Technical Description
Technical description Technical description 9. 1 Information signals 9. 1. 1 Configuration All of the information signals created, with the exception of those which display the cause of an inoperable device (‘Malfunction’, see e.g. page 16 Self test), are not self-retaining. This means that the signal is only issued whilst the signal conditions are present. If the signal conditions are only very brief, there are rules as to the minimum visual/acoustic signal duration, with which the described information signals also comply. -
Page 37: Acoustic Signals
Technical description 9. 1. 3 Acoustic signals The acoustic signals described below satisfy the requirements in terms of distinctiveness. The acoustic signal is issued for as long as the signal conditions apply. But at least one complete signal sequence is played. The acoustic signal can be switched on or off in the Settings menu. -
Page 38: Troubleshooting
Technical description 9. 2 Troubleshooting Issue Complete failure of the device. Possible cause 1. Power supply failure. 2. Defective power fuse. 3. Power cord connector is not properly connected to device socket. Recommended remedy 1. Check that there is electricity to the wall outlet. 2. - Page 39 Technical description Troubleshooting Issue Too little light. Possible cause 1. Ends of light cable and/or endoscope are soiled. 2. Light cable or endoscope is defective. 3. LED service life has been exceeded. Recommended remedy 1. Clean ends of light cables, and light entrances and exits on the endoscope. 2.
- Page 40 1. Turning the device off and on again. 2. Remove any moisture on the front of the device with a clean, dry cloth. Issue Device certificate expired. Possible cause The device certificate is no longer up-to-date or invalid. Recommended remedy Contact KARL STORZ Customer Service.
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Page 41: Technical Data
Technical description 9. 3 Technical data power LED saphira TL410US Line voltage 100…240 V∼ Line frequency 50/60 Hz Power consumption 180 VA Line fuse 2 x T4.0 AH 250V Dimensions (w x h x d) 305 mm x 120 mm x 370 mm Weight 7.4 kg... - Page 42 Technical description Standard compliance (for TL410US) According to IEC 60601-1, IEC 60601-1-6, ANSI/ AAMI ES60601-1, CAN/CSA-C22.2 No. 60601-1: • Type of protection against electric shocks: Protection Class I • Degree of protection against electric shock: Applied part type CF • Type of protection against moisture: Drip-water protection as per IPX0 According to IEC 60601-1-2: Observe the information on electromagnetic compatibility in chapter 11 (p.
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Page 43: Technical Documentation
Software is the property of KARL STORZ, (III) that Customer neither owns nor acquires any claim or intellectual property right in or to the Software, and (IV) KARL STORZ retains all right, title, and interest in and to the Software, at all times, regardless of the form or media in or on which the original or other copies of the Software may exist. -
Page 44: Spare Parts, Recommended Accessories
10. 2 Recommended accessories Item Cat. no. Light cable 495NAC Power cord ‘Hospital Grade’ (USA) 400B One-pedal footswitch, one-stage UF101 WO10275 Patch cable, CAT6a, length 2.0 m, UL-listed For detailed information please contact: KARL STORZ SE & Co. KG Postfach 230 78503 TUTTLINGEN/GERMANY... -
Page 45: Electromagnetic Compatibility (Emc) Information
(EMC) Information 11. Electromagnetic Compatibility (EMC) Information NOTE: In this chapter, the term device is used instead of ‘cold light fountain power LED saphira TL410US’. The device is suitable for use in professional healthcare facility environment. 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 magnetic resonance imaging). - Page 46 Electromagnetic Compatibility (EMC) Information Table 1 – Compliance level for Immunity tests Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment.
- Page 47 Electromagnetic Compatibility (EMC) Information Table 2 Test levels for Proximity fields from RF wireless communications equipment Test Band Immunity Compliance Frequency Service Modulation Test Level V/m level V/m 380 – 390 TETRA 400 Pulse modulation 18 Hz GMRS 460 FM ± 5 kHz deviation 1 kHz Sine 430 –...
- Page 48 Electromagnetic Compatibility (EMC) Information Table 3 – Test levels for Radiated and conducted Immunity Tests Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment.
- Page 49 Electromagnetic Compatibility (EMC) Information Table 4 – Emission class and group Guidelines and manufacturer’s declaration – electromagnetic emissions The device 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.
- Page 50 Electromagnetic Compatibility (EMC) Information Table 5 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
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Page 51: Subsidiaries
KARL STORZ SE & Co. KG KARL STORZ Endoscopy Suomi OY KARL STORZ Polska Sp. z o.o. KARL STORZ ENDOSKOPE KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou Branch Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Taivaltie 5 ul. Bojkowska 47 East Mediterranean & Gulf (branch) Room 02B &... - Page 52 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Telefon: +49 7461 708-0 Telefax: +49 7461 708-105 E-Mail: info@karlstorz.com Web: www.karlstorz.com...