Table of contents Table of contents 1 General information............................ 5 Read the instructions for use ........................ 5 Read the instructions for use of combinable products................ 5 Scope................................ 5 Description of warning messages...................... 6 2 Normal use.............................. 7 Intended use ............................. 7 Indications for use............................. 7 Contraindications............................ 7 Target user populations .......................... 7 Patient groups............................ 7 3 Safety ................................ 8 Serious incidents ............................ 8...
Page 4
Table of contents 11 Fault correction ............................ 27 11.1 Product malfunctions.......................... 27 12 Subsidiaries.............................. 28 ® Instructions for use • C-MAC Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR...
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.
General information 1.4 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 warning messages describe the following levels of danger. WARNING WARNING Designates a possible imminent risk.
Normal use 2 Normal use 2.1 Intended use 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.
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 –...
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. 3.6 Electromagnetic interference Medical electrical products are subject to special precautions regarding electromagnetic compatibility and must be installed and commissioned according to the tables on electromagnetic compatibility.
Safety 3.7 Patient leakage current Patient leakage currents from products may add up if powered endoscopes and powered endotherapy devices are used simultaneously. Excessively high leakage current levels may result in the patient becoming injured. Only use products of the same type together; e.g., CF. 3.8 National guidelines on airway management Failure to observe the national guidelines on airway management may put the patient at risk.
Product description 4 Product description 4.1 Product overview Video laryngoscope (8403AXC/BXC/DXC/GXC/KXC/MXC/HXP) without guidance for suction catheter Socket for video connecting cable Multifunction button Video laryngoscope (8403EXC) without guidance for suction catheter Video laryngoscope (8403AX/BX/HX) with guidance for suction catheter Video connecting cable (8403X) Laryngoscope connection socket Monitor connection socket ®...
Product description 4.2 Possible combinations ® The C-MAC Video Laryngoscopes from series 8403 can be operated with the following monitors: ® – C-MAC Monitor 8403ZX (software version: 704v300 or higher) ® – C-MAC Monitor 8404ZX ® – C-MAC Pocket Monitor 8403XD ®...
Product description 4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol Meaning Number of products in the product packaging Article no. CE conformity mark With this mark, the manufacturer declares the compliance of the prod- ucts with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body.
Product description 4.4.2 Symbols on the product Symbol Meaning Follow instructions for use Type BF device Serial number CE conformity mark With this mark, the manufacturer declares the compliance of the prod- ucts with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body.
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 16
Preparation Check whether the coating is damaged. Defect pattern: Poor general condition Ensure that the components and connections are complete, intact, and positioned correctly. Check whether there are residues and/or moisture at the interfaces. Check the mobility of the components. Instruments that can be dismantled should be assembled for this purpose.
Preparation 5.2.2 Functional test Inspect the product for the following characteristics: – Fully functional control keys – Securely positioned connecting cable – Functional image transmission – Sufficient image quality – Light transmission ® 5.3 Connecting the C-MAC Monitor Insert the video connecting cable into the socket of the video laryngoscope. Pay attention to the orientation pin on the plug and socket.
Page 18
Preparation ® 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. ®...
Preparation ® 5.4 Connecting the C-MAC Pocket Monitor The Pocket Monitor can be connected to the product while folded up or down. ® 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 lugs of the plug connection are opposite each other and the plug is fully inserted.
Preparation ® 5.5 Connecting C-Hub Connect the video connecting cable to the socket on the product. 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 ®...
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 22
Application ® Instructions for use • C-MAC Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR...
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 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR...
8 Maintenance, servicing, repairs, and disposal 8.1 Repairs to 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).
Accessories and spare parts 9 Accessories and spare parts 9.1 Accessories Item Order no. Forceps acc. to MAGILL, modified acc. to 809125 BOEDEKER, 25 cm Forceps acc. to MAGILL, for children, modi- 809120 fied acc. to BOEDEKER, 20 cm Bag for intubation set C22, ULM model 8403YE ®...
Electromagnetic compatibility 10 Electromagnetic compatibility 10.1 Electromagnetic compatibility 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 ®...
Page 27
Connecting cable not con- Push the cable firmly nected correctly into the socket on the product Defective camera electronics Send product to KARL STORZ for repair TFT screen defective Blurry picture, striping, Telescope is dirty Clean with cotton swab streaking and alcohol solution or...
Page 28
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 29
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 30
Subsidiaries ® Instructions for use • C-MAC Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR...
Page 31
Subsidiaries ® Instructions for use • C-MAC Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_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...
Need help?
Do you have a question about the C-MAC 8403 Series and is the answer not in the manual?
Questions and answers