Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for Storz Power LED Saphira
Summary of Contents for Storz Power LED Saphira
- Page 1 Instructions for use Power LED Saphira...
- Page 2 06-2023 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.
-
Page 3: Table Of Contents
4.5 Ambient conditions ........................17 5 Preparation ............................18 5.1 Unpacking the product ......................18 5.2 Reprocessing the product ......................18 5.3 Setting up the product ....................... 18 5.4 Connecting the product ......................19 Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... - Page 4 9.7 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ................. 36 10 Errors and messages ........................38 10.1 Troubleshooting ......................... 38 11 Overview of mitigating warnings ....................40 12 Subsidiaries ............................41 Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR...
-
Page 5: General Information
ü Prerequisite that must be met before carrying out an action. Step 1 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 Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 6: Description Of Warning Messages
FCI both in technical literature and in common usage. Therefore, we will continue to refer to any procedures in- volving the Power LED Saphira (TL410) as PDD applications. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 7: Normal Use
The application of the products in question is carried out under the responsibility of a medical specialist. 2.7 Patient population There are no restrictions in terms of patient groups for this product. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
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. 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
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
The high level of light intensity produced by the light source may lead to permanent eye damage or blindness, and may cause tissue and items facing the light output to heat up. Do not look into the light output. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 11: Functionality Of The Touch Screen
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_V2.0_06-2023_IFU_CE-MDR... -
Page 12: Product Description
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. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 13: Technical Data
400–700 nm Blue light 390–430 nm 4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no. Serial number Number of products in the product packaging Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 14: Symbols On The Product
The color may differ on the product. The symbol is black/white on the packag- ing label. OPAL1 PDD ON/OFF (standby) Visible radiation Potential equalization connector Applied part of the type CF Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 15: Symbols On The Type Plate
4.4.3 Symbols on the type plate Symbol Meaning Manufacturer Date of manufacture Medical device Prevention of pollution by electronic devices Separate collection of electrical and electronic devices. Do not dispose of in household refuse. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
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 Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 17: Ambient Conditions
Light off 4.5 Ambient conditions Transport and storage 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_V2.0_06-2023_IFU_CE-MDR... -
Page 18: 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_V2.0_06-2023_IFU_CE-MDR... -
Page 19: 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 20: Connecting The Footswitch
5.6 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_V2.0_06-2023_IFU_CE-MDR... -
Page 21: 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_V2.0_06-2023_IFU_CE-MDR... -
Page 22: 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 4.0 or higher is connected. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 23: 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_V2.0_06-2023_IFU_CE-MDR... -
Page 24: 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 25: Product Information
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. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 26: 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_V2.0_06-2023_IFU_CE-MDR... -
Page 27: 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_V2.0_06-2023_IFU_CE-MDR... -
Page 28: 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_V2.0_06-2023_IFU_CE-MDR... -
Page 29: 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 Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 30: 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 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_V2.0_06-2023_IFU_CE-MDR... -
Page 32: Electromagnetic Compatibility
Guidance and manufacturer’s declaration – Electromagnetic immunity The product is intended for use in the electromagnetic environment specified below. The user should make sure that it is used in such an environment. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... - Page 33 Immunity test acc. 3 V/m 80 MHz to 3 V/m 80 MHz to to IEC 61000-4–3 2.7 GHz 2.7 GHz for high-frequency electromagnetic fields Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR...
- Page 34 4, 25, UMTS 2450 2400 – 2570 Bluetooth, Pulse modula- WLAN 802.11 tion b/g/n, 217 Hz RFID 2450, LTE Band 7 5240 5100 – 5800 WLAN 802.11 Pulse modula- tion 5500 217 Hz 5785 Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR...
- Page 35 Field strengths from fixed transmitters, e.g., base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment with regard to Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR...
- Page 36 The customer or user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment (transmitters) and the product as recommended below, according to the output energy of the communications equipment. Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR...
- Page 37 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. 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_V2.0_06-2023_IFU_CE-MDR...
-
Page 38: Errors And Messages
HIVE not connected) Patch cable defective Check the patch cable for damage and replace if necessary Touchscreen does not react Touchscreen was actuated dur- Switch the product off and ing the start process Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... - Page 39 Device certificate expired Certificate not up to date Check and set the date and time 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_V2.0_06-2023_IFU_CE-MDR...
-
Page 40: Overview Of Mitigating Warnings
WARNING No modification of this equipment is allowed. WARNING Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... -
Page 41: Subsidiaries
E-Mail: info-lt-lv@karlstorz.com Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Istanbul, Turkey Phone: +90 216 442 9500, Fax: +90 216 442 9030 **Sales for Industrial Endoscopy Instructions for use • Power LED Saphira • WXD410_EN_V2.0_06-2023_IFU_CE-MDR... - 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 Saphira • WXD410_EN_V2.0_06-2023_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...
Need help?
Do you have a question about the Power LED Saphira and is the answer not in the manual?
Questions and answers