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Table of Contents
Related Manuals for Storz C-MAC S
Summary of Contents for Storz C-MAC S
- Page 1 Instructions for use C-MAC S PEDIATRIC IMAGER...
- Page 2 03-2021 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............................ 4 Read the instructions for use ........................ 4 Read the instructions for use of combinable products................ 4 Scope................................ 4 Description of warning messages...................... 4 2 Normal use.............................. 5 Intended use ............................. 5 Indications for use............................. 5 Contraindications............................ 5 Target user populations .......................... 5 Patient population............................. 5 3 Safety ................................ 6 Serious incidents ............................ 6... -
Page 4: 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. Keep the instructions for use clearly visible next to the product. -
Page 5: Normal Use
Normal use 2 Normal use 2.1 Intended use C-MAC S IMAGERs are used in conjunction with C-MAC S video laryngoscopes for single use and a monitor to visualize the respiratory tracts and the vocal cords during endotracheal intubation and to inspect and examine the upper respiratory tract. C-MAC S IMAGERs are designed for transient use in invasive procedures through a body orifice and can be reused if reprocessed properly. -
Page 6: Safety
Safety 3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): – Death of a patient, user, or another person –... -
Page 7: Product Description
Product description 4 Product description 4.1 Product overview Telescope C-MAC S PEDIATRIC IMAGER Socket for video connecting cable Multifunction button (BlueButton) Connection for leakage tester or pressure compensation cap Video connecting cable Connection socket for connection to the monitor Connection socket for connection to the C-MAC S PEDIATRIC IMAGER Instructions for use •... -
Page 8: Overview Of Accessories
Product description 4.2 Overview of accessories ® C-MAC monitor 8403 ZX ® C-MAC S video laryngoscope blade for single use ® C-MAC S video laryngoscope blade for single use, with attached ® C-MAC S PEDIATRIC IMAGER and connected ® C-MAC POCKET MONITOR 8403XD Instructions for use •... -
Page 9: Possible Combinations
Product description 4.3 Possible combinations The C-MAC S PEDIATRIC IMAGER requires additional accessories for normal use: – C-MAC S video laryngoscope blade – Camera control unit (CCU), unless integrated in the monitor – Monitor C-MAC S PEDI- C-MAC S Monitor Camera control unit ATRIC IMAGER video laryn- goscope blade... -
Page 10: Symbols On The Packaging
Product description 4.6 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Unique Device Identifier Article no. Number of products in the product packaging Serial number Consult the printed or electronic instructions for use Not MR safe Federal (USA) law restricts this device to sale by or on the order of a physician. -
Page 11: 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 evidence of shipping damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. - Page 12 Preparation Make sure that the cable is fully inserted. There must not be a gap. Connect the video connecting cable coming from the C-MAC S PEDIATRIC IMAGER to the connection socket at the side .. or at the rear of the C-MAC monitor. Switch on the monitor by pressing the power switch.
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Page 13: Connection To The C-Mac Pocket Monitor
Preparation The C-MAC monitor 8403ZX/8404ZX enables two KARL STORZ CMOS video units to be connected with Lemo connectors. Video units from other manufacturers cannot be connected. If two cameras are connected, the user must select the camera for which the images are to be displayed in the menu (refer to the instructions for use for the C-MAC monitor 8403ZX/8404ZX). - Page 14 Preparation The C-HUB II with serial number 3044 and above is supplied with the latest software. Please check whether a live image is displayed if you have a C-HUB II with a serial number lower than 3044. If no live image is displayed, a software update is required for the C-HUB II.
- Page 15 Preparation ð The lamp on the front of the C-HUB II and the multifunction button on the C-MAC S PEDIATRIC IMAGER light up permanently. The devices are now ready for use. Instructions for use • C-MAC S PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 16: Application
Application 6 Application 6.1 Using the C-MAC S IMAGER The high-intensity light emitted by the C-MAC S IMAGER can result in increased temperatures at the light outlet. However, these always stay below the value which could cause burns. 6.2 Function of the multifunction button The multifunction button on the C-MAC S PEDIATRIC IMAGER can be used to activate single image capture and video recording for documentation purposes. -
Page 17: Disassembly
Disassembly 7 Disassembly 7.1 Disassembling the product ® Push on the ejection mechanism on the side of the C-MAC S laryngoscope blade. ® Take hold of the C-MAC S PEDIATRIC IMAGER by the coupling mechanism between ® ® the connecting cable or C-MAC PM and C-MAC S PEDIATRIC IMAGER and pull the ®... -
Page 18: 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 19: Accessories And Spare Parts
Accessories and spare parts 9 Accessories and spare parts 9.1 Accessories Item Order number MAGILL forceps, modified by B OEDEKER, length 25 cm, suitable for the 809125 endoscopic removal of foreign bodies, for use with video laryngoscopes of sizes 2–4 Protection cap, for the C-MAC, system interface to C-MAC, video laryngo- 8403YZ scope 8403xxx, and C-MAC PM 8403XD, as well as C-MAC connecting... -
Page 20: Faults And Messages
Carry out new white carried out correctly. balance. – C-MAC S PEDIATRIC – Send supply unit to IMAGER defective. KARL STORZ for repair. Color rendering alternates. – Camera connecting – Have a new camera cable is defect. connecting cable fitted. Image cannot be saved –... - Page 21 Faults and messages Description of issue Possible causes Remedy – Format the memory card on the PC with FAT (standard). SD memory card cannot be – SD memory card is – Format the SD memory written on formatted incorrectly card on the PC with FAT (standard).
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Page 22: Electromagnetic Compatibility
Electromagnetic compatibility 11 Electromagnetic compatibility 11.1 Electromagnetic compatibility The applied part described in these instructions for use has been tested as a system with the following basic devices. For relevant electromagnetic compatibility (EMC) information, refer to ‘Electromagnetic Compatibility (EMC) information’ in the instructions for use for these basic devices: Basic device Instructions for use... -
Page 23: Subsidiaries
KARL STORZ Veterinary Endoscopy-America, Inc. Email: info-be@karlstorz.com 1 South Los Carneros Road, Goleta, CA 93117, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 805 968-7776, Fax: +1 805 685-2588 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Email: info@karlstorzvet.com... - Page 24 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. Email: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 25 Subsidiaries Instructions for use • C-MAC S PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 26 Subsidiaries Instructions for use • C-MAC S PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 27 Subsidiaries Instructions for use • C-MAC S PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 28 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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