Storz C-MAC 8403ZX Instructions For Use Manual
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Storz C-MAC 8403ZX Instructions For Use Manual

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C-MAC Monitor
8403ZX

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Summary of Contents for Storz C-MAC 8403ZX

  • Page 1 Instructions for use C-MAC Monitor 8403ZX...
  • Page 2 02-2021 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.

  • Page 3: Table Of Contents

    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...................... 5 2 Normal use.............................. 6 Intended use ............................. 6 Indications for use............................. 6 Contraindications............................ 6 Target user populations .......................... 6 Patient groups............................ 6 3 Safety ................................ 7 Serious incidents ............................ 7...
  • Page 4 Table of contents Switching the monitor to standby mode.................... 33 Switching off the monitor........................ 33 Performing a reset .......................... 34 7 Maintenance, servicing, repairs, and disposal.................... 35 Replacing the battery.......................... 35 Maintenance ............................ 35 Safety inspection in accordance with IEC 62353 ................... 35 7.3.1 Visual inspection..........................  35 7.3.2 Electric measurements ........................

  • 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. Keep the instructions for use clearly visible next to the product.

  • Page 6: Normal Use

    Normal use 2 Normal use 2.1 Intended use Monitors for the C-MAC® system are used for visualizing anatomy and for storing and playing back videos and images of an endoscopic procedure. Monitors for the C-MAC® system are non-invasive and are designed for transient or short-term use in invasive procedures through a body orifice or surgically invasive procedures.

  • Page 7: 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 8: Failure Of Products

    Safety Observe the instructions for use and interface specifications of the combined devices and system components. Only use approved accessories. 3.6 Failure of products The product may fail during use. Have a replacement product ready for each application or plan for an alternative surgical technique.
  • Page 9 Observe the information on electromagnetic compatibility; see chapter Electromagnetic compatibility [p. 39]. In case of uncertainties, seek expert advice from KARL STORZ. The use of accessories and cables other than those specified in the instructions for use may result in increased emissions or decreased immunity of the product. When using other accessories and cables, the operator is responsible for checking compliance with IEC 60601-1-2 for this particular product.

  • Page 10: Product Description

    Product description 4 Product description 4.1 Product overview Connection for CMOS videoendoscope 2 On/Off button (secondary camera) Connection for CMOS videoendoscope 1 Charging pilot lamp (orange) (primary camera) Mains connection: Control buttons Reset button Progress bar SD slot Function symbols Status bar USB port Operating pilot lamp (green)
  • Page 11 Product description Item Order no. Flex. Intubation Videoscope 11304BCX ® C-MAC 10331BX Electronic Module 8402X ® C-MAC Connecting Cable 8403X ® C-MAC Video Laryngoscope MAC #3 8401AX ® C-MAC Video Laryngoscope MAC #4 8401BX ® C-MAC Video Laryngoscope D-BLADE 8401HX ®...

  • Page 12: Technical Specifications

    Product description Item Order no. ® C-MAC S Imager 8402XS ® C-MAC S Imager 8403XS ® C-MAC S Imager 8403XSI ® C-MAC S Video Laryngoscope MAC #4 051114-10 ® C-MAC S Video Laryngoscope MAC #3 051113-10 ® C-MAC S Video Laryngoscope D-BLADE 051116-10 ®...
  • Page 13 This product contains free software which falls under the terms of the General Public License (GPL) and Lesser General Public License (LGPL). To obtain the source code for this software, contact Technical Support via the German KARL STORZ website (www.karlstorz.com). Recommended default settings for accessories...

  • Page 14: Symbols Employed

    Product description Recommended default settings for accessories Article Brightness Contrast Saturation Hue [%] 8403XS, 8403XSI 8403XSP 10331BX 11102CM 11272V, 11272VE, 11272VU, 11272VUE 11301ABX 11301BNX 11302BDX 11303BCX 11303BNX 11304BCX 13303E TP010, TP012 TH130 4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol Meaning Manufacturer...

  • Page 15: Symbols On The Product

    Product description Symbol Meaning Consult the printed or electronic instructions for use Fragile, handle with care Not MR safe Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way 4.4.2 Symbols on the product...

  • Page 16: Ambient Conditions

    Product description 4.5 Ambient conditions Operating conditions Temperature 0 °C ... 40 °C Charging conditions -10 °C ... +60 °C (rechargeable battery) Relative humidity 30 – 70 % (non-condensing) Air pressure 700 – 1,080 hPa Average product life cycle 5 years Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR...

  • Page 17: 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 18: Connecting The Power Supply Unit

    Damage due to incompatible charger The product may be damaged if an incompatible charger is used. Only use chargers supplied by KARL STORZ. Insert the connector for the power supply unit into the socket on the monitor. Secure the connector using the swivel nut.

  • Page 19: Connecting A Video Unit

    5.4 Connecting a video unit The video unit connecting cable can be inserted or removed while the monitor is in operation. All video units from KARL STORZ can be attached to both connections, see Possible combinations [p. 10]. Video units from other manufacturers cannot be connected.

  • Page 20: Connecting The Primary Camera

    ü The external monitor supports one of the following resolutions: 1024 x 768 pixels, 1280 x 720 pixels. ü When a KARL STORZ monitor is connected as an external monitor, the following adapters are available: HDMI-DVI adapter (20919010). ü The C-MAC monitor is switched off.

  • Page 21: Switching On The Monitor

    Preparation 5.6 Switching on the monitor Press the On/Off button to switch the monitor on. ð The green operating pilot lamp illuminates. ð The monitor is switched on. 5.7 Inserting the SD card ü Before using with the C-MAC monitor, the SD card must be formatted on a PC with FAT (standard).

  • Page 22: Application

    Application 6 Application 6.1 Basic information on operation The screen’s display quality may be affected by bright light (e.g. sunlight). 6.2 Monitor status bar The following information is displayed in the monitor's status bar: – Battery charge state – Free memory capacity on the connected storage media (SD card, USB stick) –...
  • Page 23 Application Symbol Meaning Replace battery: Maximum battery capacity is less than 50% of the original maxi- mum capacity SD card storage capacity 100% of memory capacity available 75% of memory capacity available 50% of memory capacity available 25% of memory capacity available 0% of memory capacity available USB stick storage capacity 100% of memory capacity available...

  • Page 24: Control Buttons And Functions

    Application Symbol Meaning 0% of memory capacity available Progress bar and action currently being carried out Left: Progress bar shows the progress of the action currently being carried out Right: Symbol shows the action currently being carried out Shows the progress of the camera update Shows the progress of the switch-on procedure Shows the progress of the reset Shows the progress of the SD card formatting...
  • Page 25 Application Certain functions can also be controlled via the camera. The following requirements must be met: – The camera has control buttons – The control buttons on the camera are enabled The menu consists of levels 1 to 10. Pressing the control button next to the Next level symbol accesses the functions one level down.
  • Page 26 Application Level 1 Wrench Switches to the level 2 functions. Level 2 Video selection menu Plays back and/or deletes video recordings saved on the SD card. Pressing the control button switches to the level 2A functions. Level 2A Scroll up through list Scrolls up through the list of saved video recordings.
  • Page 27 Application Level 2 Image selection menu View recorded images Views and deletes recorded still images on the SD card. Pressing the control button switches to the level 2A functions. Level 2A Scroll up through list Scrolls up through the list of saved images. Scroll down through list Scrolls down through the list of saved images.
  • Page 28 Application Level 4 Reset Restores all factory settings. The camera settings for brightness, contrast, saturation and hue are reset to the recommended values. The settings for image rotation, button lock and the Freeze function are reset to the default settings. Delete content of SD card Pressing the control button for an extended period deletes the entire content of the SD card.
  • Page 29 Application Level 6 Color saturation Calls up the +/– function symbols for adjusting the color saturation. The color sat- uration value is shown as a percentage and is saved for this endoscope/camera. Pressing the menu wheel closes the +/− function symbols level. Calls up the +/–...
  • Page 30 If no software is available on the SD card, the symbol is grayed out. A software update may only be performed by an authorized KARL STORZ em- ployee. Before starting the software update, ensure that the battery is charged or that the C-MAC Monitor is connected to the mains.

  • Page 31: Transferring Data From An Sd Card To A Usb Stick

    Application Level 10 Toggle Freeze/Still image capture Toggles between Freeze with still image capture and Still image capture. Freeze with still image capture freezes the live image on the screen and saves the image to the SD card. Still image capture saves the live image on the screen to the SD card. The setting is saved for this endoscope/camera.
  • Page 32 Application – The symbol indicating a critical situation appears in the bottom right-hand corner of the monitor Status messages Battery charge state SD card capacity USB stick capacity Warning messages Critical battery charge state The battery charge state has reached a critical level. Connect the monitor to the power supply.

  • Page 33: Switching The Monitor To Standby Mode

    Application Acknowledging warning message Press the control button next to the warning message. ð The symbol for the critical situation disappears. The Wrench symbol appears. 6.6 Switching the monitor to standby mode Standby mode enables the monitor to be quickly ready for operation again in the event of brief interruptions.

  • Page 34: Performing A Reset

    Application ð The monitor is switched off. 6.8 Performing a reset If the device stops responding although connections and power supply are in order, a system error has occurred and a system reset must be carried out. The reset switch is located in a recess to protect it from unintentional activation. Insert a ballpoint pen or similar into the reset switch next to the SD slot and carefully push downwards.

  • Page 35: Maintenance, Servicing, Repairs, And Disposal

    The battery’s capacity decreases over time. KARL STORZ recommends replacing the battery after 2 years. The battery may only be replaced by persons authorized by KARL STORZ. 7.2 Maintenance Maintenance work may only be carried out by KARL STORZ or a company authorized by KARL STORZ. Interval Maintenance work...

  • Page 36: Disposing Of The Product

    Maintenance, servicing, repairs, and disposal Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products. 7.5 Disposing of the product The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment (WEEE).

  • Page 37: Accessories And Spare Parts

    Accessories and spare parts 8 Accessories and spare parts 8.1 Accessories Item Order no. ® Stand, for C-MAC Monitor, height 120 cm, 8401YA five-feet roller stand with antistatic castors, crossbar 25 cm x Ø 25 mm, for positioning the monitor, with storage basket for laryngo- scopes, dimensions (W x D x H): 30 x 20 x 10 cm Crossbar, for stand 8401YA, 8401YAA...

  • Page 38: Spare Parts

    Accessories and spare parts 8.2 Spare parts Article Order no. Power supply unit, for C-MAC® Monitor ET27-30-0004695 8403ZX VESA 75 Quick Clip, with 4 clamping screws, 8401YCA ® for mounting C-MAC to holding arms up to diameter 25 mm Exchangeable adaptors for charger Article Order no.

  • Page 39: Electromagnetic Compatibility

    Electromagnetic compatibility 9 Electromagnetic compatibility 9.1 General notes on the operating environment The product is suitable for use in professional healthcare settings. Professional healthcare facilities include physician offices, dental offices, limited care facilities, freestanding surgical centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system for MRT).
  • Page 40 Electromagnetic compatibility Interference im- EN/IEC 60601 test Compliance level Electromagnetic envi- munity tests level ronment – guidelines 100% for 250/300 cy- 100% for 250/300 cy- ated with an uninter- cles cles ruptible power supply or a battery. Magnetic field at 30 A/m at 50 Hz / 30 A/m at 50 Hz / If image distortion oc- the power fre-...
  • Page 41 Electromagnetic compatibility Test fre- Frequency Radio service Modulation Immunity Compliance quency band test level level 1,720 1,700 – 1,990 GSM 1800, Pulse modula- CDMA 1900, tion 1,845 GSM 1900, 217 Hz DECT, 1,970 LTE band 1, 3, 4, 25, UMTS 2,450 2,400 –...
  • Page 42 Electromagnetic compatibility Interference immunity EN/IEC 60601 test Compliance Electromagnetic envi- tests level level ronment – guidelines Field strengths from fixed HF transmitters as deter- mined by an electromag- netic site survey should be less than the compli- ance level in each fre- quency range d = 1.2 √P 80 MHz to 800 MHz...
  • Page 43 Electromagnetic compatibility Emission measurements Compliance Electromagnetic environment – Guidelines Voltage fluctuations/flicker emis- complies power supply network that supplies sions as per IEC 61000-3-3 buildings used for domestic pur- poses. 9.6 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product The product is intended for use in an electromagnetic environment in which HF disturbances are controlled.

  • Page 44: Faults And Messages

    – Defective camera electronics – Send the videoendoscope or – Screen defective supply unit to KARL STORZ for repair. Cloudy image, stripes, – Videoendoscope – Clean the streaks, or similar telescope is soiled videoendoscope telescope with a cotton –...
  • Page 45 Faults and messages Video stream cannot be – No MPEG-4 Codec – Install an MPEG-4 played back on the PC moni- installed codec on the PC. Unable to write to the SD – SD card is formatted – Format the SD card on card incorrectly the PC with FAT...

  • Page 46: 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 47 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 48 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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