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Summary of Contents for Storz Power LED Saphira
- Page 1 Instructions for use Power LED Saphira...
- Page 2 08-2021 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
5.2 Setting up the product ..................... 17 5.3 Connecting the product ....................18 5.4 Connecting the light cable ....................18 5.5 Connecting the footswitch ....................19 5.6 Putting the product into operation .................. 20 Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... - Page 4 9.7 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ..............36 10 Faults and messages ....................... 38 10.1 Troubleshooting ....................... 38 11 Overview of mitigating warnings ....................40 12 Subsidiaries ..........................41 Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
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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 • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 6: Description Of Warning Messages
FCI both in technical literature and in common usage. Therefore, we will con- tinue to refer to any procedures involving the Power LED Saphira (TL410) as PDD applications. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 7: Normal Use
The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.5 Patient groups There are no restrictions in terms of patient groups for this product. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 8: Safety
Only use devices and components that have standardized interfaces and do not breach the intended use of the product. Only make changes to the product if these changes are approved by KARL STORZ. Note the following when using the product with HF devices: Certain devices or accessories can represent a hazard in lower power settings. -
Page 9: Dangers From Electrical Current
All electrical installations in the operating room in which the product is connected and used must meet 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: Dangers From Uv Radiation
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 • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 11: Risk Of Explosion And Fire
If the functionality of the touchscreen is limited, the product cannot be used correctly. Patients, users, and third parties may be injured. Do not use the product if the touch screen is defective. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 12: Product Description
Please note that the products listed here may not yet be available in all countries due to differences in approval requirements. The product can be combined with the following components: – Light cables Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 13: Technical Data
Date of manufacture Medical device Article no. Serial number Number of products in the product packaging Unique Device Identifier Consult the printed or electronic instructions for use Fragile, handle with care Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 14: Symbols On The Product
4.4.2 Symbols on the product Symbol Meaning Follow instructions for use OPAL1 PDD ON/OFF (standby) Visible radiation Potential equalization connector Applied part of the type CF KS HIVE socket Connection socket, e.g., for footswitch Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 15: Symbols On The Type Plate
Prevention of pollution by electronic devices Separate collection of electrical and electronic devices. Do not dispose of in household refuse. 4.4.4 Symbols on the user interface Symbol Meaning Settings Cancel Confirm Scroll backwards Browse up Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 16: Ambient Conditions
Light on Light off 4.5 Ambient conditions Storage/transport conditions Temperature -18°C ... +60°C (16.4°F ... 140°F) Relative humidity 5 – 85% (non-condensing) Air pressure 600–1,080 hPa Operating conditions Temperature 0°C ... 40°C (32°F ... 104°F) Relative humidity 5 – 85% (non-condensing) Max. operating altitude 3,000 m Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 17: Preparation
Set the product down on a horizontal, flat surface or a video cart. Make sure that the power cord can be unplugged at any time. Keep the product out of reach of patients (> 1 m). Ensure adequate air circulation. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 18: Connecting The Product
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 19: Connecting The Footswitch
5.5 Connecting the footswitch Insert the footswitch connecting cable fully into the socket. To do this, align the red dot on the cable with the red dot on the footswitch socket. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 20: Putting The Product Into Operation
Check whether the product is correctly connected. ð The product is in manual white-light mode after being switched on, and the light is switched off. Tap the Settings button to adjust the settings. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 21: Application
If the product is connected to the IMAGE1 S camera control unit via the KS HIVE connecting cable, the light is controlled automatically and optimally adjusted to each situation. ü IMAGE1 S with software release version 4.3 is connected. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 22: Activating Fluorescence Mode
Press the footswitch again to return to white-light mode. 6.5 Settings Make sure that the light is switched off and the Light button turns white. Tap the Settings button. ð The Settings screen appears with the following sub-menus: Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 23: 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 24: Product Information
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. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 25: Switching Off The Product
The pitch of the information signal is modulated at a frequency of 1.5 Hz by ± 2 Hz at a time. 5 different harmonics are generated and the sound sequence occurs once. Signals indicating the product's safety state are repeated and sound every 15 s. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 26: Availability Signal
6.7.3 Availability signal The pitch of the availability signal is modulated with a frequency of 1.5 Hz by ± 2 Hz each time. 5 different harmonics are generated. Harmonics of the availability signal Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 27: 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 • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... - Page 28 Insert a new fuse. Only use fuses with the specified values; see chapter Technical data [p. 13]. Place the screw inserts back into the line fuse holder. Connect to the power supply. Switch on the product and test for proper operation. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
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Page 29: Safety Inspection In Accordance With Iec 62353
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 30 Contact KARL STORZ SE & Co. KG, a KARL STORZ branch or an authorized dealer to find out the address of the collection point in your area. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
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Page 31: Accessories And Spare Parts
One-pedal footswitch, one-stage UF101 OR1 patch cable CAT6a 2.0 m UL WO10275 8.2 Spare parts Article Order no. Mains fuse, 100 – 240 V, T 4.0 AH 250 V AC, IEC 127 format 2027690 Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 32: Electromagnetic Compatibility
The power supply qual- transients/bursts ity should be that of a ± 1 kV for input and ± 1 kV for input and acc. to IEC typical commercial or output lines output lines 61000-4-4 hospital environment. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... - Page 33 80 MHz 80 MHz ence, induced by 1 kHz 80% AM modu- 1 kHz 80% AM modu- high-frequency lation lation fields acc. to IEC 6 V in ISM band 6 V in ISM band 61000-4-6 Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
- Page 34 Guidelines Conducted RF distur- 3 V 10 V Portable and mobile RF bances acc. to IEC communications equip- 150 kHz to 80 MHz 61000-4-6 ment should be used no closer to any part of the Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
- Page 35 If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
- Page 36 Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range ap- plies. Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
- Page 37 Electromagnetic compatibility The product was tested for compatibility with HF surgical devices in accordance with IEC 60601-2-2 Appendix BB. Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
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Page 38: Faults And Messages
Patch cable defective Check the patch cable for damage and replace if necessary Touchscreen does not react Touchscreen was actuated Switch the product off during the start process and on Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... - Page 39 Wipe with a clean, dry cloth Device certificate expired Certificate not up to date Contact Service Incorrect time stamp Date and time are not set Check and set the date and time Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
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Page 40: Overview Of Mitigating Warnings
WARNING No modification of this equipment is allowed. WARNING Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... -
Page 41: Subsidiaries
Phone: +358 (0)96824774, Fax: +358 (0)968247755 E-mail: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 E-mail: info-gr@karlstorz.com *Repair & Service Subsidiary Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR... - Page 42 Room 701A Building 5 & Room 501 Building 7, No. 3000 Longdong Avenue, Pilot Free Trade Zone, 201203, Shanghai, People’s Republic of China Phone: +86 21 60339888, Fax: +86 21 60339808 E-mail: info@karlstorz.com.cn Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_IFU_CE-MDR...
- Page 43 Subsidiaries Instructions for use • Power LED Saphira • WXD410_EN_V1.0_08-2021_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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