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

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Summary of Contents for Storz C-MAC 8403XD

  • Page 1 Instructions for use ® C-MAC Pocket Monitor...
  • Page 2 10-2020 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 Intended conditions of use ........................ 6 Patient groups............................ 6 Target user populations .......................... 6 3 Safety ................................ 7...
  • Page 4 Table of contents Disassembling the product ........................ 28 8 Maintenance, servicing, repairs, and disposal.................... 29 Repairing the product .......................... 29 Disposing of the product ........................ 29 9 Accessories and spare parts ........................ 30 Accessories............................. 30 Spare parts ............................. 30 10 Electromagnetic compatibility........................ 31 10.1 General notes on the operating environment .................. 31 10.2 Table 1 –...

  • 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 ® C-MAC Pocket Monitors are used for visualizing anatomy and for storing videos and images ® during an endoscopic procedure. C-MAC Pocket Monitors 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, in the opinion of the responsible physician, inspection of the upper respiratory tract or endotracheal intubation is...

  • 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 Do not use damaged products. 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. 3.7 Combination with other components Combination of the product with non-suitable instruments and devices can result in uncontrolled behavior and injury to patients, users, and third parties.

  • Page 9: Product Description

    Product description 4 Product description 4.1 Product overview ® ® C-MAC  Pocket Monitor (PM) with OTI C-MAC Pocket Monitor Protective display (OTI = Open to Intubate) Cover ® Battery compartment C-MAC Video Laryngoscope ® Video connector for C-MAC  Video BlueButton multifunction button Unit 4.2 Possible combinations Video units from other manufacturers cannot be connected.

  • Page 10: Technical Specifications

    Product description Article Order no. ® C-MAC Video Laryngoscope MIL #1 8403GXC ® C-MAC Video Laryngoscope D-BLADE 8403HX ® C-MAC Video Laryngoscope D-BLADE, Ped. 8403HXP ® C-MAC Video Laryngoscope MAC #2 8403KXC ® C-MAC Video Laryngoscope MIL #2 8403MXC ® C-MAC Video Laryngoscope MIL #3 8403NXC...

  • Page 11: Symbols Employed

    Product description ® C-MAC Pocket Monitor 8403XD Storage capacity Photo: 80,000 Video: 44 minutes File format Photo: JPEG Video: Battery Charger 8403XDL Power supply: 100−240 V ~, 50−60 Hz Power consumption: Max. 8 W Power connection: Power adaptor for EU/UK/US/AUS/CN Cable length: 1.5 m Dimensions Wall power supply (W x H x D): Approx.

  • Page 12: Symbols On The Product

    Product description Symbol Meaning Fragile, handle with care Manufacturer Not MR safe Unique Device Identifier 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 Item number Number of products in the product packaging 4.4.2 Symbols on the product...
  • Page 13 Product description Operating conditions Temperature 0°C ...40°C Relative humidity 30–70% Air pressure 700–1,080 hPa Battery Charger 8403XDL / USB Data Cable 8403XDD / Connecting Cable 8403XDP Storage/transport conditions Temperature -10°C ...60°C Relative humidity 5–95% Operating conditions (transient area) Temperature 0°C ...40°C Relative humidity 5–95% ®...

  • Page 14: 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 15 Preparation   ATTENTION   Power cord damage! To remove the power cord from the socket, pull only on the plug housing. Do not pull on the cord! Charging station status display Symbol Status display (LED) Meaning Green (no battery inserted) Power supply unit is connected Green (battery inserted) Battery is fully charged Orange...
  • Page 16 Preparation Notify customer service. Inserting the battery in the charging station ® Insert the battery with the C-MAC  PM logo facing upwards into the charging station. The arrow on the battery must point in the same direction as the arrow on the charging station. ð...

  • Page 17: Inserting And Removing The Battery

    Preparation 5.2.2 Inserting and removing the battery Inserting the battery ® Insert the battery into the battery compartment of the C-MAC  Pocket Monitor. The arrow on the battery must point in the same direction as the arrow on the ® C-MAC  Pocket Monitor.

  • Page 18: Replacing The Power Supply Unit Adaptor

    Preparation 5.2.3 Replacing the power supply unit adaptor The battery charger’s power supply unit can be adapted to country-specific power sockets by using exchangeable adaptors. To replace the adaptor, push together the two branches of the U-shaped retainer. Pull the adaptor out towards the front and remove it. Insert the new adaptor into the guide and push it towards the cable until it clicks audibly into place.

  • Page 19: Connecting The Product

    Preparation Country-specific configuration Adaptor for China Adaptor for USA/Japan Adaptor for UK Adaptor for Australia Adaptor for Europe 5.3 Connecting the product ® ® The C-MAC Pocket Monitor can be connected to a C-MAC  Video Unit while folded up or down.

  • Page 20: Connecting The Product With The Connecting Cable

    Preparation ð Monitor is folded upwards: The product is ready for use. ð The BlueButton multifunction button lights up blue as soon as the image and video recording function is ready. Provided that the battery is still supplying power, the video unit’s LED lights up even if the ®...

  • Page 21: Application

    Application 6 Application 6.1 Switching on the product Fold the display upwards. Turn the display to the left. ð The product is ready for use. If the monitor is folded upwards, the product is immediately ready for use. 6.2 Checking the image quality Turn the display so that the image is easy to identify and the display quality is not impaired by lighting conditions.
  • Page 22 Application Blue information bar Approx. 5 seconds after the pocket monitor is switched on, the blue information bar is displayed at the top of the screen for a few seconds. Display Meaning Left Remaining storage capacity in minutes Center Current software version Right Number of the directory in which the saved data are stored Green information bar...

  • Page 23: Functions And Displays Of The Bluebutton Multifunction Button

    Application Display Meaning Left Remaining storage capacity in minutes Center (without function) Right Number of the directory in which the saved data are stored If the remaining storage capacity falls below 10 minutes, an orange-red information bar is displayed. © Displaying the C-MAC Power Save timer function The display turns off automatically after 10 minutes.

  • Page 24: Energy Management

    Application Meaning Blue, permanently lit up The recording function is enabled for images and videos. Green, flashing Video recording is active. Green, lights up briefly Single image capture is active. 6.5 Energy management ® C-MAC Power Save The product has a switch-off function with a timer to save energy. The display turns off automatically after 10 minutes.

  • Page 25: Video Recording

    Application ð The multifunction button briefly lights up green and then switches back to blue. ð The current image on the screen is saved to the product’s integrated memory card. 6.7 Video recording Starting video recording Press the BlueButton multifunction button for approx. 2 seconds. ð...
  • Page 26 Application Connect the product’s video connector to the data cable socket. The connector and socket orientation pins must be precisely aligned on top of each other. Connect the data cable’s USB plug to the computer. ð The product is powered by the computer. ð...

  • Page 27: Switching Off The Product

    Application Disconnecting the product from the computer Click on the "Eject" command on the computer. ð The "Hardware can be safely removed" message is displayed on the computer. Disconnect the data cable’s USB plug from the computer. Disconnect the product’s video connector from the data cable socket. 6.9 Switching off the product Turn the display to the right.

  • Page 28: Disassembly

    Disassembly 7 Disassembly 7.1 Disassembling the product The product can be removed during operation and connected to another video unit. Disconnect the product from the video unit. ® Instructions for use • C-MAC Pocket Monitor • DRE117_EN_V1.0_10-2020_IFU_CE-MDR...

  • Page 29: 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 30: Accessories And Spare Parts

    Accessories and spare parts 9 Accessories and spare parts 9.1 Accessories Item Order no. ® Charging Station for C-MAC  PM 8403XDL Rechargeable Battery 8403XDA ® C-MAC Pocket Monitor connecting cable 8403XDP USB Data Cable 8403XDD ® Protection cap for C-MAC System Interface 8403YZ ®...

  • Page 31: Electromagnetic Compatibility

    Electromagnetic compatibility 10 Electromagnetic compatibility 10.1 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 32 Electromagnetic compatibility Interference im- EN/IEC 60601 test Compliance level Electromagnetic envi- munity tests level ronment – guidelines 100 kHz repetition 100 kHz repetition Surges acc. to ± 1 kV voltage outer ± 1 kV voltage outer The power supply qual- IEC 61000-4-5 conductor – outer con- conductor –...
  • Page 33 Electromagnetic compatibility 10.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment Test fre- Frequency Radio service Modulation Immunity Compliance quency band test level level 380 – 390 TETRA 400 Pulse modula- tion 18 Hz 430 – 470 GMRS 460, FM ± 5 kHz FRS 460...
  • Page 34 Electromagnetic compatibility Interference immunity EN/IEC 60601 test Compliance Electromagnetic envi- tests level level ronment – guidelines Radiated HF distur- 3 V/m 3 V/m product, including cables, bances acc. to IEC than the recommended 80 MHz to 2.5 GHz 61000-4-3 separation distance calcu- lated from the equation applicable to the fre- quency of the transmitter.
  • Page 35 Electromagnetic compatibility 10.5 Table 4 – Emission class and group Guidelines and manufacturer’s declaration – electromagnetic emissions The product is intended for use in such an environment as specified below. The customer or user of the device should ensure that it is used in such an environment. Interference emission mea- Conformity Electromagnetic environment –...

  • Page 36: Faults And Messages

    No image, LED on videoendo- TFT screen defective. Send the scope illuminated. ® C-MAC  Pocket Monitor to KARL STORZ for repair. No picture, TFT screen dark. CMOS videoendoscope not Push in the CMOS fully inserted. videoendoscope as far as it will go.
  • Page 37 10 minutes; the device must remain connected to the power supply during this time. If the fault reoccurs, send the ® C-MAC  Pocket Monitor to KARL STORZ for repair. ® Instructions for use • C-MAC Pocket Monitor • DRE117_EN_V1.0_10-2020_IFU_CE-MDR...

  • Page 38: 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 39 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 40 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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