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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: [email protected]
www.karlstorz.com

CFH518 •

• V1.0 • 12-2021 • IFU • CE-MDR

Содержание 8404ZX

Страница 1: ...Instructions for use C MAC Monitor 8404ZX en ...

Страница 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 rights reserved 12 2021 ...

Страница 3: ... ingress of liquid in electrical components 9 3 8 Patient leakage current 9 3 9 Electromagnetic interference 9 3 10 National guidelines on airway management 10 4 Product description 11 4 1 Product overview 11 4 2 Possible combinations 12 4 3 Technical specifications 14 4 4 Ambient conditions 16 4 5 Symbols employed 17 4 5 1 Symbols on the packaging 17 4 5 2 Symbols on the product 18 4 5 3 Symbols ...

Страница 4: ... 43 6 8 Access and security concept 43 7 Maintenance servicing repairs and disposal 45 7 1 Updating the firmware 45 7 2 Replacing the battery 45 7 3 Maintenance 45 7 4 Safety inspection in accordance with IEC 62353 45 7 4 1 Visual inspection 46 7 4 2 Electric measurements 46 7 5 Repairing the product 46 7 6 Disposing of the product 46 8 Accessories and spare parts 47 8 1 Accessories 47 8 2 Spare p...

Страница 5: ...atible products are not followed patients users and third parties may be injured or the product may be damaged Read the instructions for use of the compatible products carefully and follow all the safety notes and warnings Read the reprocessing instructions of the compatible products carefully and follow all the safety notes and warnings 1 3 Scope This instruction manual is valid for Product name ...

Страница 6: ...y notes in the instructions for use must be observed The warnings use the following levels of danger WARNING WARNING Designates a possible imminent risk If this is not avoided it could lead to death or serious injuries CAUTION CAUTION Designates a possible imminent risk If this is not avoided it could lead to minor injuries NOTICE NOTICE Designates a possibly harmful situation If this is not avoid...

Страница 7: ...esponsible physician inspection of the upper respiratory tract or endotracheal intubation is indicated 2 3 Contraindications The use of laryngoscopes and video laryngoscopes is contraindicated if in the opinion of the responsible physician use is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition Laryngoscopes and video laryngoscopes mus...

Страница 8: ...ess and correct assembly Do not continue to use damaged products Dispose of the product properly Do not leave broken off components inside the patient Do not overload the product with mechanical stress Do not bend bent products back to their original position 3 3 Unsterile product The product is not sterile when delivered The use of non sterile products poses a risk of infection for patients users...

Страница 9: ... are used simultaneously the patient leakage currents of the product can accumulate Excessively high leakage current levels may result in the patient becoming injured Only use products of the same type together particularly if CF products are required If the product is connected to a type BF generator the product will also correspond to type BF 3 9 Electromagnetic interference Medical electrical p...

Страница 10: ... the operator is responsible for checking compliance with IEC 60601 1 2 for this particular product To prevent increased electromagnetic emissions or reduced electromagnetic immunity of the product only use accessories transducers and cables recommended or supplied by the manufacturer 3 10 National guidelines on airway management Failure to observe the national guidelines on airway management may ...

Страница 11: ...ct damage If sharp objects are inserted into the microphone opening the product may be damaged and leak Do not insert any objects into the microphone opening 1 2 7 8 9 9 3 5 4 6 C MAC Monitor 8404ZXK front 1 8 IPS display 6 Integrated microphone 2 Slot for SD card 7 USB plug 3 On Off button 8 HDMI port 4 Operational readiness LED 9 Connection for video unit 5 Battery charge state LED ...

Страница 12: ...onents Video units for anesthesia Item Order no C MAC connecting cable 8403X C MAC S Imager 8402XS C MAC S Imager 8403XS C MAC S Imager 8403XSI C MAC S Pediatric Imager 8403XSP C MAC S Video Laryngoscope MILLER 0 051110 10 C MAC S Video Laryngoscope MILLER 1 051111 10 C MAC S Video Laryngoscope MAC 3 051113 10 C MAC S Video Laryngoscope MAC 4 051114 10 C MAC S Video Laryngoscope D BLADE 051116 10 ...

Страница 13: ...403HXP C MAC Video Laryngoscope MAC 2 8403KXC C MAC Video Laryngoscope MIL 2 8403MXC C MAC Video Laryngoscope MAC 3 8404AX C MAC Video Laryngoscope MAC 4 8404BX C MAC Video Laryngoscope D BLADE 8404HX C MAC Video Laryngoscope MAC 3 8404AXC C MAC Video Laryngoscope MAC 4 8404BXC C MAC Video Laryngoscope MIL 0 8404DXC C MAC Video Laryngoscope MAC 0 8404EXC C MAC Video Laryngoscope MIL 1 8404GXC C MA...

Страница 14: ...deo Cystoscope 11272VU C View Video Cystoscope 11272VE C View Video Cystoscope 11272VUE Video uretero renoscope FLEX XC1 091271 06 Video uretero renoscope FLEX XC1 091279 06 Video units for imaging Item Order no C CAM 20290132 E BOX TP012 H1 Camera head TH130 C MAC Video Laryngoscope MAC 3 8403AX C MAC Video Laryngoscope MAC 4 8403BX C MAC Video Laryngoscope MIL 3 8403NXC 4 3 Technical specificati...

Страница 15: ...icrophone The IP degree of protection can only be ensured if the connection sockets are sealed using the designated rubber seals Charger ET27 30 0006091 Designation Value Power supply 100 240 V 50 60 Hz 600 300 mA Output current Max 2 5 A Output voltage power output 12 V up to 30 W Power connection Power adaptor for EU UK USA AUS JP Degree of protection acc to IEC 60259 IP 40 Cable length 2 m Dime...

Страница 16: ... License LGPL The free software used and the correspond ing licenses are shown in the License information menu see chapter Password protected settings p 29 The source code for this software is available via Technical Support which can be contacted via the German KARL STORZ website www karlstorz com 4 4 Ambient conditions Storage transport conditions Temperature 10 C 50 C 14 F 122 F Relative humidi...

Страница 17: ...ed 4 5 1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no Serial number Number of products in the product packaging Unique Device Identifier Consult the printed or electronic instructions for use Fragile handle with care Keep dry Temperature limit Humidity limit ...

Страница 18: ...ber after the CE mark indicates the responsible notified body The EU directives relevant to the product can be found in the EU Decla ration of Conformity which can be requested from KARL STORZ 4 5 2 Symbols on the product Symbol Meaning Follow the instructions for use The color may differ on the product The symbol is black white on the packaging label Power socket Applied part type BF Serial numbe...

Страница 19: ...usehold refuse CE marking With this marking the manufacturer declares the conformity of the prod uct with the applicable EU directives A code number after the CE mark indicates the responsible notified body The EU directives relevant to the product can be found in the EU Decla ration of Conformity which can be requested from KARL STORZ Medical device Date of manufacture Data matrix code example di...

Страница 20: ...holder and slide the holding arm through the holder 3 Release the holder in the desired position ð The monitor is secured in place on the holding arm 5 3 Connecting the power supply The C MAC Monitor can be powered using either a connected power supply unit or the integrated lithium ion battery 1 Before each use ensure that the power supply to the monitor for the planned procedure is provided eith...

Страница 21: ...ert the connector for the power supply unit into the socket on the monitor 2 Secure the connector using the swivel nut 3 Plug the power supply unit into the wall socket holding onto the plug housing not the cable itself ð The monitor is connected to the power supply ð The green indicator on the power supply unit lights up ð The orange status LED lights up ð The battery charges 5 3 2 Disconnecting ...

Страница 22: ...Country specific configuration The power supply unit has exchangeable adaptors which enable it to be adapted to suit the respective power sockets Adaptor for EUROPE Adaptor for UK Adaptor for USA Japan Adaptor for Australia IEC connection ROW Adaptor cable for USA Japan 5 4 Connecting a video unit Two KARL STORZ video units can be connected to the monitor either when the monitor is switched off or...

Страница 23: ...sing ð The video unit that is connected first is recognized as the primary video unit 5 5 Connecting the external monitor ü The external monitor supports a resolution of 1 920 x 1 080 pixels Full HD at a frame rate of 30 fps ü The HDMI cable has a maximum length of 1 80 m Active HDMI repeaters are required for longer cables Connect the external monitor to the HDMI port on the C MAC Monitor ...

Страница 24: ... the power supply unit is connected see chapter Connecting the power supply p 20 1 Press the On Off button to switch the monitor on ð The operational readiness status LED lights up green ð The symbol on the On Off button lights up blue ð The monitor is switched on ð The start screen is displayed If a video unit is connected the video image is transmitted to the monitor If a video unit is not conne...

Страница 25: ...es ð The monitor switches to standby mode After 5 minutes in standby mode the monitor switches off The monitor switches to standby mode after 20 minutes of inactivity Depending on which video unit is connected this time may be longer 6 3 Using storage media 6 3 1 Inserting the SD card ü The storage medium is formatted with FAT32 and only has one partition ü The monitor is switched off 1 Insert the...

Страница 26: ...the SD card and connecting cable are connected to the device during capture 6 3 2 Inserting the USB stick ü The storage medium is formatted with FAT32 and only has one partition 1 Insert the USB stick into the USB port on the side of the monitor ð The information area displays the available memory capacity 6 4 User interface 6 4 1 Start screen layout The user interface of the C MAC Monitor is subd...

Страница 27: ... The image and video area displays the field of view of the connected video units see chapter Images and videos p 35 Menu bar The menu bar contains the following areas Status bar The status bar provides information on the memory capacity of the connected storage media and the charge state of the battery see chapter Icons and functions on the user interface p 30 Information area The i icon is used ...

Страница 28: ...pace on the SD card being used Memory capacity and remaining storage space on the USB stick being used Battery charge state Firmware version of the C MAC Monitor The icons for the connected storage media and the battery charge state are also displayed on the status bar on the user interface see chapter Icons and functions on the user interface p 30 6 4 3 Function space The function space contains ...

Страница 29: ... not available and are therefore not displayed see chapter Icons and functions on the user interface p 30 and see chapter Password protected settings p 29 6 4 4 Password protected settings A default password is set when the product is delivered see chapter Access and security concept p 43 1 Enter the password ð The following dialog appears 2 Tap the checkmark to confirm the entry ð The menus of th...

Страница 30: ...nction space Selects video unit functions or changes the product settings Video recording Starts or stops a video recording see chapter Capturing stills and recording videos p 39 This function is only available if an SD card has been inserted Switch video unit The video unit connected at the side of the housing is the primary source This function is only available if two video units are connected ...

Страница 31: ...D card has not been inserted and the Freeze function has been enabled Full screen Displays the live image of the primary video unit see chapter Selecting the viewing mode p 35 This function is only available if the picture in picture or side by side viewing mode has been activated Picture in picture PiP The live image of the secondary video unit is shown at the bottom left of the live image of the...

Страница 32: ...ss of the monitor Hue Adjusts the hue of the monitor Saturation Adjusts the saturation of the monitor Contrast Adjusts the contrast of the monitor Timer Activates or deactivates the timer Image position The displayed live image is in its original position or has been rotated by 180 Still image freeze Enables or locks the Freeze function Operation via video unit Enables or locks the operating butto...

Страница 33: ...pter Copying data from an SD card to a USB stick p 42 Only available if an SD card and USB stick have been inserted Clear SD card Deletes the content of the SD card Only available if an SD card has been inserted Date and time Sets the date and time Password protected settings Calls up the protected system settings Confirm Cancel Select Play Pause Stop Increase value Decrease value ...

Страница 34: ...ed and the power supply is sufficient see chapter Updating the firmware p 45 Firmware update for video unit Updates the firmware of the connected video unit This function is only available if an SD card with update files has been in serted a video unit is connected and the power supply is sufficient see chapter Updating the firmware p 45 Exports the system log log files to the inserted SD card Lic...

Страница 35: ...rmware version of the connected video units Firmware version of the monitor Battery charge state Low charge state below 20 Critical charge state below 10 The red bar flashes Critical charge state operating time of approx 10 minutes The battery is charging Replace battery The maximum battery capacity is less than 50 of the origi nal maximum capacity 6 5 Images and videos 6 5 1 Selecting the viewing...

Страница 36: ...by side or Picture in picture button 6 5 1 2 Picture in picture display In the picture in picture viewing mode the minimized live image of the secondary video unit is shown in the bottom left corner of the image of the primary video unit 1 To change the primary video unit tap the Switch video unit button 2 To switch the view tap the Side by side or Full screen button 6 5 1 3 Side by side display T...

Страница 37: ... bar ð The Image position button changes in the function space 6 5 2 Screen settings The screen s display quality may be affected by bright light e g sunlight The hue saturation contrast and brightness of the primary video can be adjusted to optimize the display quality 1 Call up the Screen settings menu ð The function area appears at the bottom of the screen 2 Tap the Brightness button to adjust ...

Страница 38: ...8403MXC 47 45 54 50 8404AX 8404AXC 8404BX 8404BXC 8404HX 50 50 50 50 8404DXC 8404EXC 8404GXC 8404KXC 8404MXC 8404HXP 50 50 50 50 8403XS 8403XSI 50 50 47 50 8403XSP 40 54 53 50 10331BX 52 45 30 50 11102CM 52 45 30 50 11272V 11272VE 11272VU 11272VUE 40 34 25 50 11301ABX 52 45 30 30 11301BNX 40 40 35 50 11302BDX 52 45 30 50 11303BNX 52 45 30 50 11304BCX 52 45 30 50 13303E 52 45 30 50 TP012 52 40 30 5...

Страница 39: ... still of a live image can be created and saved if an SD card has been inserted ü An SD card with sufficient memory capacity has been inserted Tap the Image capture button ð The still is saved to the memory card 6 5 3 3 Freeze with SD card inserted If a memory card has been inserted the Freeze icon is added to the Image capture icon on the start screen ü A video unit with a freeze function has bee...

Страница 40: ...formation bar 2 To return to the live image display tap the Freeze button again 6 5 4 Viewing and deleting captures Captures can be viewed and deleted in the image and video area of the function space The most recently created stills and videos are displayed in a preview 2 3 4 1 1 Last saved image 3 Last saved video 2 Number of saved images 4 Number of saved videos ...

Страница 41: ...displayed 6 5 4 2 Deleting a capture 1 Tap a capture to mark it for deletion 2 Hold down the Delete button until the button has been completely filled in ð A progress bar shows the status of the deletion process ð Once the deletion process is complete a confirmation window appears 3 Confirm that you wish to delete the capture 6 5 5 Performing white balance To adapt the live image to the current li...

Страница 42: ...the timer that appears ð The timer starts 6 5 6 2 Stopping the timer The timer stops and is set to 00 00 if the monitor goes into standby mode or is switched off The recorded time is shown on saved images and videos 6 5 6 3 Resetting the timer Tap the timer to reset it to 00 00 ð The timer starts to count again from 00 00 without interruption 6 6 Copying data from an SD card to a USB stick The USB...

Страница 43: ... Enter the current date in the format DD MM YYYY 3 Enter the current time in the format hh mm 4 Tap del to correct any mistakes 5 Tap the checkmark to confirm the entry ð The settings are saved 6 8 Access and security concept Certain settings are password protected to prevent the product and the sensitive areas of the menu from being accessed by unauthorized parties The default password when the p...

Страница 44: ...o to the Password protected settings area and call up the Change password menu ð The following dialog appears 2 Enter a numerical password of between 4 and 8 digits in the top input field 3 Enter the new password again in the bottom input field 4 Tap the checkmark to confirm the entry ð The password is changed ...

Страница 45: ... unit 7 2 Replacing the battery 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 3 Maintenance Maintenance work may only be carried out by KARL STORZ or a company authorized by KARL STORZ Interval Maintenance work To be performed by annually Safety inspection KARL STORZ Servic...

Страница 46: ...ule Please contact your local KARL STORZ subsidiary or authorized dealer see the list of subsidiaries 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 6 Disposing of the product The product meets the requirements of the Directive on Waste Electrical ...

Страница 47: ...OLL E Airway Mobile Stand 20020085 C MAC TROLL E Mobile Stand 20020086 8 2 Spare parts Item Order no Power supply unit for C MAC Monitor 8404ZX ET27 30 0006091 VESA 75 Quick Clip with 4 clamping screws for mounting C MAC to holding arms up to diameter 25 mm 8401YCA Exchangeable adaptors for charger Item Order no Adaptor for EUROPE ET27 30 0004697 Adaptor for UK ET27 30 0004698 Adaptor for USA Japa...

Страница 48: ...magnetic envi ronment guidelines Electrostatic dis charge ESD acc to IEC 61000 4 2 8 kV contact dis charge 15 kV air discharge 8 kV contact dis charge 15 kV air discharge Floors should be made of wood concrete or covered with ceramic tiles If floors are cov ered with synthetic ma terial the relative hu midity must be at least 30 Electrical fast transients bursts acc to IEC 61000 4 4 2 kV for power...

Страница 49: ...ciently low Immunity test acc to IEC 61000 4 3 for radiated ra dio frequency electromagnetic fields 3 V m 80 MHz to 2 7 GHz Refer to Table 2 for wireless proximity RF field test levels 3 V m 80 MHz to 2 7 GHz Immunity to con ducted distur bances induced by radio fre quency fields acc to IEC 61000 4 6 3 Vrms on 150 kHz to 80 MHz 1 kHz 80 AM modu lation 6 Vrms in ISM band 3 Vrms on 150 kHz to 80 MHz...

Страница 50: ...the electromagnetic environment specified below The user of the product should make sure that it is used in such an environment Interference immunity tests EN IEC 60601 test level Compliance level Electromagnetic envi ronment guidelines Conducted HF distur bances acc to IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms Portable and mobile HF communications equip ment should be used no closer to any pa...

Страница 51: ...nt due to fixed transmitters an electromagnetic site survey should be considered If the measured field strength at the location where the device is used exceeds the above compli ance levels the device should be monitored to ensure proper function If abnormal perfor mance is observed additional measures may be necessary such as re orienting or relocating the product b Over the frequency range from ...

Страница 52: ...ment transmitters and the product as recommended below according to the output energy of the communications equipment Rated power of the transmitter W Separation distance d m according to the transmitter frequency 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters whose max...

Страница 53: ...m Send the product to KARL STORZ for repair Cloudy image stripes streaks or similar Video unit s telescope is dirty Video unit s contacts are dirty Clean the video unit s telescope with a cotton swab and alcohol solution or special cleaning paste Clean the video unit s contacts Color distortions White balance not carried out correctly Hue set incorrectly Screen or video unit defective Carry out ne...

Страница 54: ...one partition The battery charge state LED flashes when the power sup ply unit is connected Battery cannot be charged Remove the power supply unit Allow the monitor to cool down Reconnect the power supply unit If the status LED continues flashing send the product to KARL STORZ for repair The battery charge state LED lights up green but the dis play in the status bar does not show 100 The monitor i...

Страница 55: ... 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 Žalgirio St 94 LT9300 Vilnius Lithuania Phone 370 5 272 0448 Mobile 370 685 67 000 E mail info lt lv karlstorz com KARL STORZ Endoskopi Danmark A S Skovlytoften 33 2840 Holte Denmark Phone 45 45162600 Fax 45 45162609 E...

Страница 56: ...lding 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 Endoscopy Shanghai Ltd Shanghai Branch Room 701A Building 5 Room 501 Building 7 No 3000 Longdong Avenue Pilot Free Trade Zone 201203 Shanghai People s Republic of China Phone 86 21 60339888 Fax 86 21 60339808 E m...

Страница 57: ...Subsidiaries Instructions for use C MAC Monitor CFH518_EN_V1 0_12 2021_IFU_CE MDR 57 ...

Страница 58: ...Subsidiaries Instructions for use C MAC Monitor CFH518_EN_V1 0_12 2021_IFU_CE MDR 58 ...

Страница 59: ...Subsidiaries Instructions for use C MAC Monitor CFH518_EN_V1 0_12 2021_IFU_CE MDR 59 ...

Страница 60: ...ORZ 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 CFH518 EN V1 0 12 2021 IFU CE MDR ...

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