Storz C-MAC 8403 Series Instructions For Use Manual Download Page 6 | Manualshive

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Instruction For Use • C-MAC

®

Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US •

V4.3

6

2 Product description

2.1 Product overview

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Summary of Contents for C-MAC 8403 Series

Page 1: ...Instruction For Use C MAC Video Laryngoscope 8403xxx and Connection Cable 8403X en...

Page 2: ...to use or disclose the contents thereof unless express consent is given Publisher KARL STORZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Tel 49 7461 708 0...

Page 3: ...Damage to the instrument 12 5 Installation and commissioning 14 5 1 Visual and functional test 14 5 2 Initial operation 15 6 Application 17 6 1 Connection to the C MAC monitor 17 6 2 Connection to the...

Page 4: ...32 8 5 Pre cleaning 32 8 6 Manual cleaning 32 8 7 Assembly inspection and care 33 8 8 Packaging 33 8 9 Sterilization 33 8 9 1 Hydrogen peroxide H O sterilization ASP STERRAD 33 8 9 2 Hydrogen peroxide...

Page 5: ...e thus ask that you read these instructions carefully before proceeding to work with the instrument Keep these instructions available for ready reference If the instructions for use are not followed p...

Page 6: ...Product description Instruction For Use C MAC Video Laryngoscope 8403xxx and Connection Cable 8403X 96076019EN US V4 3 6 2 Product description 2 1 Product overview...

Page 7: ...oscope 2 Socket for video connecting cable 4 3 Multifunction button BlueButton 4 Video connecting cable 5 Connection socket on monitor 6 Connection socket on laryngoscope 7 C MAC Pocket Monitor 8 TFT...

Page 8: ...bol Meaning Consult the instructions for use Keep away from sunlight Keep dry Temperature limit In accordance with US federal law 21 CFR 801 109 this product may only be sold to or on prescription fro...

Page 9: ...table as an introduction to laryngoscopy technique The use of the C MAC video laryngoscopes must be used in accordance with the airway algorithm in the respective country of application or the officia...

Page 10: ...e Instruction For Use C MAC Video Laryngoscope 8403xxx and Connection Cable 8403X 96076019EN US V4 3 10 No physical impairments that could diminish perception of activation and alarm signals visual an...

Page 11: ...to death or serious injuries CAUTION CAUTION Designates a possible imminent risk If this is not avoided it could lead to minor injuries ATTENTION ATTENTION Designates a possibly harmful situation If t...

Page 12: ...not use damaged products 4 9 Combination with other devices and accessories Combinations of medical devices are only assured to be safe if they are identified as such in the respective instructions f...

Page 13: ...Safety Instruction For Use C MAC Video Laryngoscope 8403xxx and Connection Cable 8403X 96076019EN US V4 3 13 The C MAC video laryngoscopes may not be sterilized with steam...

Page 14: ...e device can no longer be used for its intended purpose Check the instrument for Mechanical damage and changes for example sharp edges burred edges rough surfaces protruding and bent parts examples Fi...

Page 15: ...th other monitors via the camera control unit C HUB II 20 2903 01 software version 721v105 or higher WARNING Danger due to user error in the wrong viewing mode Wrong viewing mode Before each use or af...

Page 16: ...users and third parties Never look into the light output of a connected light transmission or endoscope Wear suitable protective equipment To prevent the telescope from fogging up the C MAC video lar...

Page 17: ...g cable 6 to the socket 2 of the video laryngoscope The orientation pin on the plug and socket facilitates connection 2 Make sure that the cable is fully inserted There must not be a visible gap 2 6 C...

Page 18: ...e photo video recording function is ready the multi function button 3 goes on 17 18 3 6 2 Connection to the C MAC pocket monitor The 8403 xxx video laryngoscopes can only be connected to the C MAC PM...

Page 19: ...e that the lugs of the plug connection are opposite each other 6 2 1 Switching on the Open to Intubate OTI displays If the C MAC PM is closed when connected to the video laryngoscope blade the followi...

Page 20: ...s is adjusted automatically Manual adjustment is not necessary The C MAC video laryngoscope with C MAC PM is ready for operation 6 2 2 Switching off the Open to intubate OTI Displays 1 Turn the OTI di...

Page 21: ...t is not necessary to perform a white balance 6 3 Connection to the C Hub II The video laryngoscopes 8403 xxx can only be connected to the C HUB II 20 2903 01 software version 721v105 or higher Older...

Page 22: ...vated using the multifunctional button 3 on the video laryngoscope Documentation with the multifunctional button of the video laryngoscope can be performed on the C MAC monitor 8403 ZX and C MAC PM 84...

Page 23: ...le image capture by pressing the multifunction button 3 once and briefly The current image on the screen is saved on the SD memory card inserted into the connected monitor 8403 ZX During single image...

Page 24: ...ertion of an oxygen or suction catheter only with 8403 AX BX HX If a blade with oxygen or suction catheter guide is used the probe catheter must be advanced over the guide until visibility in the imag...

Page 25: ...tem 1 Steris System 1E Steris System AMSCO1 V PRO TM 1 C MAC Video laryngoscopes Connecting ca ble This reprocessing process is part of the validated process This reprocessing process may be additiona...

Page 26: ...ological range of action of the chemicals used CAUTION Damage to the product Only perform reprocessing using chemicals approved by KARL STORZ A list of approved chemicals can be requested from hygiene...

Page 27: ...lization 7 6 Manual disinfection Required materials Cleaning gun with accessories item no 27660 1 Immerse the product completely in the disinfectant solution 2 To ensure bubble free wetting fill the l...

Page 28: ...for the individually validated methods are described in the manual Cleaning Disinfection Care and Sterilization of KARL STORZ Instruments Art no 96216003D The method must be selected taking into accou...

Page 29: ...already assembled products does not lead to sufficient sterilization Sterilize only products that are not oiled and not greased Sterilize products in disassembled state CAUTION Airing times For gas st...

Page 30: ...Video Laryngoscope 8403xxx and Connection Cable 8403X 96076019EN US V4 3 30 7 11 Reprocessing limits The end of the device s life span is largely determined by wear reprocessing methods the chemicals...

Page 31: ...ther been validated in respect of efficacy nor in respect of material compatibility by KARL STORZ 8 2 General warnings applies only to USA and Canada These products are not sterile when delivered The...

Page 32: ...cal Devices Tap water is acceptable for pre cleaning and cleaning of the instruments Specially treated water Water that has generally been treated by a multistep treatment process for example carbon f...

Page 33: ...or care of the product refer to the articles in the Care Sterilization and Storage Technology catalog 8 8 Packaging Only use standardized and approved packaging materials and packaging systems EN 868...

Page 34: ...Cycle V PRO 60 Non Lumen Cycle CAUTION Changes to the camera head V PRO sterilization may cause cosmetic changes to the camera head that do not necessarily impact the camera s functionality For steri...

Page 35: ...735 30 mg l Exposure Time 180 minutes Aeration Parameters Time At least 12 hours Temperature 55 C 131 F 8 9 4 Chemical low temperature sterilization with peracetic acid STERIS System 1E CAUTION Proces...

Page 36: ...cals used This device may be chemically disinfected using CIDEX a 2 4 glutaraldehyde solution CIDEX OPA a 0 55 ortho phthaldehyde solution or Resert XL HLD a 2 concentration of hydrogen peroxide 1 Act...

Page 37: ...to KARL STORZ as soon as you receive the repaired device In Germany you can refer repairs directly to KARL STORZ SE Co KG Abt Reparaturservice Take off Gewerbepark 83 78579 Neuhausen Germany Service h...

Page 38: ...tation of Liability As a supplier of this instrument we consider ourselves responsible for the safety reliability and performance of the instrument only if Assembly extension new adjustments changes o...

Page 39: ...usiness of KARL STORZ The medical device must always be sent to your local subsidiary see the section Subsidiaries even during the warranty period Opening of the equipment or performance of any repair...

Page 40: ...electromagnetic compatibility EMC information refer to Electromagnetic Compatibility EMC information in the instructions for use for these basic devices Basic device Instructions for use C MAC Monitor...

Page 41: ...g to Medical Device Directive MDD Class I medical devices These medical devices bear the CE mark in accordance with the Medical Device Directive MDD 93 42 EEC 13 2 Standard compliance for 8403 AX BX H...

Page 42: ...ctrical and electronic equipment WEEE At the end of its useful operating life dispose of the unit as electronic scrap Please ask KARL STORZ SE Co KG a KARL STORZ subsidiary or your authorized dealer a...

Page 43: ...on IPX8 Camera technology CMOS Resolution 300 x 400 Illumination LED white 1 W Operating storage conditions for C MAC Operating conditions 0 C 40 C 30 70 rel humidity Conditions of storage 20 C 50 C 5...

Page 44: ...C MAC PM correctly Send electronics module C MAC PM or supply unit to KARL STORZ for repair Cloudy picture stripes streaks or similar Telescope of the laryngoscope is soiled Contacts of the connectio...

Page 45: ...ion Cable 8403X 96076019EN US V4 3 45 Video stream cannot be played back on the PC moni tor No MPEG 4 Codec installed Install an MPEG 4 Codec on the PC SD memory card cannot be written on SD memory ca...

Page 46: ...el ULM made of water repellent and hard wearing surface material washable the bag contains two compart ments with several holding possibilities for C MAC video laryngoscopes with C MAC pocket monitor...

Page 47: ...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 Representation Office K stu io st 59 Len...

Page 48: ...il inquiry karlstorz com hk KARL STORZ Endoscopy Shanghai Ltd Beijing Branch Room 1805 1807 Building B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of C...

Page 49: ...Subsidiaries Instruction For Use C MAC Video Laryngoscope 8403xxx and Connection Cable 8403X 96076019EN US V4 3 49...

Page 50: ...Subsidiaries Instruction For Use C MAC Video Laryngoscope 8403xxx and Connection Cable 8403X 96076019EN US V4 3 50...

Page 51: ...KG KARL STORZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone 49 0 7461 708 0 Fax 49 0 7461 708 105 E Mail info karlstorz com www karlstorz com 96076019EN...

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