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Related Manuals for Storz POWER LED 300
Summary of Contents for Storz POWER LED 300
- Page 1 Instructions for use POWER LED 300...
- 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.
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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 Intended use ... - Page 4 Table of contents 5.6 Connecting the light cable ......................20 5.7 Putting the product into operation ..................... 22 6 Application ............................23 6.1 User interface ..........................23 6.2 Switching the light on and off ....................23 6.3 Manual light adjustment ......................24 6.4 Automatic light control ...
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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 300 • WXD587_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 Safety and warning Have a replacement product ready for each application or plan for an alternative surgical technique. Instructions for use • POWER LED 300 • WXD587_EN_V2.0_05-2024_IFU_CE-MDR...
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Page 12: Product Description
Product description 4 Product description 4.1 Product overview POWER LED 300 – Front view Power switch Light outlet point TFT touch screen Instructions for use • POWER LED 300 • WXD587_EN_V2.0_05-2024_IFU_CE-MDR... -
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 – IMAGE1 S D3-LINK (TC302) – IMAGE1 S 4U-LINK (TC304) 4.3 Technical data Description Value Power supply (AC) 100–240 V Operating frequency 50/60 Hz Line fuse 2 x T 4.0 AH 250 V Power consumption 175 VA Electrical protection class Applied part type according to IEC 60601-1 Dimensions (L x H x W) 313 x 155 x 305 mm Weight 8.6 kg 4.4 Symbols employed... -
Page 15: 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 16: 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. 4.4.4 Symbols on the user interface Symbol... -
Page 17: Ambient Conditions
Product description Symbol Meaning Confirm Cancel Remove Scroll back Scroll forward Audio signals on/off 4.5 Ambient conditions Transport and storage conditions Temperature -10°C ... +60°C (14°F ...140°F) Relative humidity 5 – 95 % (non-condensing) Air pressure 500 – 1,080 hPa Operating conditions Temperature 10°C ... 40°C (50°F ... 104°F) Relative humidity 20–85% (non-condensing) Max. -
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
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 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. The degree of protection against electric shock at the applied part as type CF according to IEC 60601-1 is guaranteed when... - Page 21 Preparation Instructions for use • POWER LED 300 • WXD587_EN_V2.0_05-2024_IFU_CE-MDR...
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Page 22: Putting The Product Into Operation
Preparation 5.7 Putting the product into operation Switch the product on with the power switch. ð The following 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 User interface The product is in manual standby mode after being switched on. The light switches off at a light intensity of 5%. The most recently used light intensity is displayed. Adjust the brightness Light on/off Settings The Settings button appears only when the light is switched off. -
Page 24: Manual Light Adjustment
Application 6.3 Manual light adjustment The brightness can be adjusted when the light is switched on or off. Tap the Plus button to increase the brightness. Tap the Minus button to decrease the brightness. ð The set brightness is shown in %. ð... -
Page 25: Service
Application 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. ð The Language screen appears. -
Page 26: Product Information
Application In the Settings screen, tap the Event protocol sub-menu. ð The Event protocol screen appears. Browse back through the screen with the Arrow. 6.5.4 Product information Information on the product can be retrieved, e.g., serial number, software version, and operating hours. -
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
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 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 300 • WXD587_EN_V2.0_05-2024_IFU_CE-MDR... -
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 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 33: 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 34: 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 35 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 36 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 37 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.
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Page 38: 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 39: 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 40: 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 41 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 42 Subsidiaries Instructions for use • POWER LED 300 • WXD587_EN_V2.0_05-2024_IFU_CE-MDR...
- Page 43 Subsidiaries Instructions for use • POWER LED 300 • WXD587_EN_V2.0_05-2024_IFU_CE-MDR...
- 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...
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