Storz 8403X Instructions For Use Manual Download Page 29

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Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR

Summary of Contents for 8403X

Page 1: ...Instructions for use C MAC Video Laryngoscopes Series 8404 en...

Page 2: ...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 ri...

Page 3: ...Electromagnetic interference 9 3 6 Patient leakage current 9 3 7 National guidelines on airway management 9 3 8 Hot components 9 3 9 High light intensity 10 4 Product description 11 4 1 Product overvi...

Page 4: ...6_EN_V1 2_11 2021_IFU_CE MDR 4 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 informa...

Page 5: ...ns in a safe place 1 2 Read the instructions for use of compatible products If the instructions for use of compatible products are not followed patients users and third parties may be injured or the p...

Page 6: ...t Unnumbered list 1st level Unnumbered list 2nd level 1 5 Description of warning messages To prevent any injury to persons or damage to property the warnings and safety notes in the instructions for u...

Page 7: ...accessories are non invasive and are designed for transient use in invasive procedures through a body orifice 2 2 Indications for use The use of laryngoscopes and video laryngoscopes is indicated if i...

Page 8: ...specting the product Do not continue to use damaged products Dispose of the product properly 3 3 Unsterile product The product is not sterile when delivered The use of non sterile products poses a ris...

Page 9: ...than those specified in the instruction manual may result in increased emissions or decreased immunity of the product When using other accessories and cables the operator is responsible for checking c...

Page 10: ...ht 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 sourc...

Page 11: ...aryngoscopes Series 8404 USB826_EN_V1 2_11 2021_IFU_CE MDR 11 4 Product description 4 1 Product overview 1 2 Video laryngoscope e g 8404HX 1 Socket for video connecting cable 2 Multifunction button Vi...

Page 12: ...quirements The product can be combined with the following monitors C MAC video laryngo scopes Monitor Series 8404 8403ZX software version 704v300 or higher 8404ZX 8403XD The series 8404 C MAC video la...

Page 13: ...uct packaging Unique Device Identifier Consult the printed or electronic instructions for use Federal USA law restricts this device to sale by or on the order of a physician CE marking With this marki...

Page 14: ...t with the applicable 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...

Page 15: ...plier immediately 5 2 Testing the product 5 2 1 Visual inspection Missing components surface changes or other damage limit the life span of the product and may mean that the product can no longer be u...

Page 16: ...ure at the interfaces 5 Use a magnifying glass to check that the optics is complete intact and securely positioned 5 2 2 Functional test Inspect the product for the following characteristics Fully fun...

Page 17: ...3 Connect the other end of the video connecting cable to the socket on the C MAC Monitor 4 Alternatively connect the other end of the video connecting cable to the socket on the rear side Another lar...

Page 18: ...he socket of the video laryngoscope Pay attention to the orientation pin on the plug and socket 2 Make sure that the orientation pins are opposite each other and the plug is fully inserted As soon as...

Page 19: ...e C HUB II 1 Connect the video connecting cable to the socket of the video laryngoscope Pay attention to the orientation pin on the plug and socket 2 Make sure that the cable is fully inserted 3 Conne...

Page 20: ...ing displayed and whether a correct image position has been selected Documentation can be carried out on the C MAC Monitor 8403ZX 8404ZX and C MAC Pocket Monitor 8403XD using the multifunction button...

Page 21: ...e multifunction button for around 2 seconds to start video recording During the video recording the multifunction button lights up in pulsating green 5 Press the multifunction button briefly to stop v...

Page 22: ...ons for use C MAC Video Laryngoscopes Series 8404 USB826_EN_V1 2_11 2021_IFU_CE MDR 22 7 Disassembly 7 1 Disassembling the product 1 Disconnect the C MAC Pocket Monitor or the connecting cable from th...

Page 23: ...t contact infections and airborne infections products must first be decontaminated KARL STORZ reserves the right to send back contaminated products 8 2 Disposing of the product The product meets the r...

Page 24: ...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 BOEDEKER 20 cm 809120 Bag for intubation set C2...

Page 25: ...AC Pocket Monitor 8403XD C HUB II 20290320 The EMC warning statements precautions notes and emission and immunity limits specified in the instructions for use for the devices also apply to the product...

Page 26: ...lurry picture striping streaking Telescope is dirty Clean with cotton swab and alcohol solution Connecting cable contacts are dirty Clean the cable contacts Screen is flickering Connecting cable not c...

Page 27: ...rlstorz se KARL STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 E mail asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representative Office algirio...

Page 28: ...05 1807 Building B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 E mail info karlstorz com cn KARL STORZ E...

Page 29: ...Subsidiaries Instructions for use C MAC Video Laryngoscopes Series 8404 USB826_EN_V1 2_11 2021_IFU_CE MDR 29...

Page 30: ...Subsidiaries Instructions for use C MAC Video Laryngoscopes Series 8404 USB826_EN_V1 2_11 2021_IFU_CE MDR 30...

Page 31: ...Subsidiaries Instructions for use C MAC Video Laryngoscopes Series 8404 USB826_EN_V1 2_11 2021_IFU_CE MDR 31...

Page 32: ...RZ SE Co KG Dr Karl Storz Stra e 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 USB826 EN V1 2 11 2021 IF...

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