Table of Contents
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Table of Contents
Related Manuals for Storz 8404 Series
Summary of Contents for Storz 8404 Series
- Page 1 Instructions for use C-MAC Video Laryngoscopes Series 8404...
- Page 2 11-2021 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
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 ... - Page 4 Table of contents 8.1 Repairing the product ...................... 23 8.2 Disposing of the product ....................23 9 Accessories and spare parts ....................24 9.1 Accessories ........................24 10 Electromagnetic compatibility ....................25 10.1 General information ......................25 11 Errors and messages ........................ 26 11.1 Product malfunctions ...
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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 Actions to be performed Action to be carried out by several steps: 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 Lists... -
Page 7: Normal Use
Normal use 2 Normal use 2.1 Intended use Video laryngoscopes Video laryngoscopes (CMOS) are used for visualizing the respiratory tracts and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video laryngoscopes (CMOS) are designed for transient use in invasive procedures through a body orifice. -
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. Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR... -
Page 9: Electromagnetic Interference
Observe the information on electromagnetic compatibility, see chapter Electromagnetic compatibility [p. 25]. In case of uncertainties, seek expert advice from KARL STORZ. Before use, a clinical/biomedical engineer or an EMC specialist should carry out an ad-hoc test of the electromagnetic radiation. -
Page 10: High Light Intensity
Safety 3.9 High light intensity 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. Set the output of the adjustable light sources to a level that is just high enough to ensure optimal illumination of the operating area. -
Page 11: Product Description
Product description 4 Product description 4.1 Product overview Video laryngoscope (e.g., 8404HX) Socket for video connecting cable Multifunction button Video laryngoscope (e.g., 8404BXC) with C-MAC Pocket Monitor Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR... -
Page 12: Possible Combinations
Product description Video connecting cable (8403X) Video unit connector Monitor connector 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 products listed here may not yet be available in all countries due to differences in approval requirements. -
Page 13: Symbols Employed
The EU legislation relevant to the product can be found in the EU Decla- ration of Conformity, which can be requested from KARL STORZ. Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR... -
Page 14: Symbols On The Product
EU directives. A code number after the CE mark indicates the responsible notified body. The EU legislation relevant to the product can be found in the EU Decla- ration of Conformity, which can be requested from KARL STORZ. 4.5 Ambient conditions Storage and transport conditions Temperature -20°C ... +50°C (-4°F ... +122°F) -
Page 15: 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 any 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 16: Functional Test
Preparation Ensure that the components and connections are complete, intact, and positioned correctly. Defect pattern: Defective socket, damaged multifunction button Check whether there are residues or moisture at the interfaces. Use a magnifying glass to check that the optics is complete, intact, and securely positioned. -
Page 17: Connecting The C-Mac Pocket Monitor
Preparation Make sure that the cable is fully inserted. Connect the other end of the video connecting cable to the socket on the C-MAC Monitor. Alternatively, connect the other end of the video connecting cable to the socket on the rear side. Another laryngoscope can be connected during use. - Page 18 Preparation Connect the C-MAC Pocket Monitor to the socket of the video laryngoscope. Pay attention to the orientation pin on the plug and socket. Make sure that the orientation pins are opposite each other and the plug is fully inserted. ð As soon as the recording function is ready, the multifunction button lights up blue. The monitor can be removed and connected to another laryngoscope during use.
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Page 19: Connecting The C-Hub Ii
Preparation 5.5 Connecting the C-HUB II Connect the video connecting cable to the socket of the video laryngoscope. Pay attention to the orientation pin on the plug and socket. Make sure that the cable is fully inserted. Connect the power supply unit to the C-HUB II. Connect the video connecting cable to the video input on the front of the C-HUB II. -
Page 20: Application
Application 6 Application 6.1 Using the product WARNING Wrong viewing mode! Risk of injury! If the viewing mode settings are changed, this can alter the image display and image position. Before each use, check whether a live image or a saved image is being displayed and whether a correct image position has been selected. -
Page 21: Inserting An Oxygen Catheter Or Suction Catheter
Application Press the multifunction button for around 2 seconds to start video recording. ð During the video recording, the multifunction button lights up in pulsating green. Press the multifunction button briefly to stop video recording. 6.2 Inserting an oxygen catheter or suction catheter Insert the catheter or the probe into the guide. -
Page 22: Disassembly
Disassembly 7 Disassembly 7.1 Disassembling the product Disconnect the C-MAC Pocket Monitor or the connecting cable from the video laryngoscope. Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR... -
Page 23: Maintenance, Servicing, Repairs, And Disposal
8 Maintenance, servicing, repairs, and disposal 8.1 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 24: Accessories And Spare Parts
Accessories and spare parts 9 Accessories and spare parts 9.1 Accessories Item Order no. Forceps acc. to MAGILL, modified acc. to BOEDEKER, 25 cm 809125 Forceps acc. to MAGILL, for children, modified acc. to 809120 BOEDEKER, 20 cm Bag for intubation set C22, ULM model 8403YE Protection cap for C-MAC system interface 8403YZ... -
Page 25: Electromagnetic Compatibility
Electromagnetic compatibility 10 Electromagnetic compatibility 10.1 General information The described product has been tested as a system with the following devices. Relevant electromagnetic compatibility (EMC) information can be found in the "Electromagnetic compatibility (EMC)" section of the instructions for use for the devices. Device Item number C-MAC Monitor... -
Page 26: Errors And Messages
Connecting cable and socket Push the connecting improperly connected cable firmly into the socket on the product Defective camera electronics Send product to KARL STORZ for repair Blurry picture, striping, Telescope is dirty Clean with cotton swab streaking and alcohol solution Connecting cable contacts... -
Page 27: Subsidiaries
E-mail: pisarna@karlstorz.si Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 E-mail: info@karlstorz.com.ar KARL STORZ Polska Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland KARL STORZ Endoskopi Norge AS Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Stamveien1, 1483 Hagan, Norway E-mail: info-pl@karlstorz.com... - Page 28 E-mail: info-az@karlstorz.com 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,...
- Page 29 Subsidiaries Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR...
- Page 30 Subsidiaries Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR...
- Page 31 Subsidiaries Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR...
- Page 32 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...