Storz C-MAC 8403ZX, Instructions For Use Manual

Page 1: ...Instructions for use C MAC Monitor 8403ZX 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: ...eakage current 8 3 11 High light intensity 8 3 12 Electromagnetic interference 8 4 Product description 10 4 1 Product overview 10 4 2 Possible combinations 10 4 3 Technical specifications 12 4 4 Symbo...

Page 4: ...5 7 5 Disposing of the product 36 8 Accessories and spare parts 37 8 1 Accessories 37 8 2 Spare parts 38 9 Electromagnetic compatibility 39 9 1 General notes on the operating environment 39 9 2 Table...

Page 5: ...the product may be damaged Read the instructions for use of the combinable products carefully and follow all the safety notes and warnings 1 3 Scope This instruction manual is valid for Product name A...

Page 6: ...f 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 phy...

Page 7: ...oduct for the following points before and after every use Completeness Good working order Rough surfaces left inadvertently Sharp corners Burred edges Correct assembly of the components Functionality...

Page 8: ...patients users and third parties may be injured Do not store liquids near the product or on the product If liquid has entered the product pull out the plug and allow the product to dry completely 3 1...

Page 9: ...ral devices e g antenna cables and external antennas should be used no closer than 30 cm from the product including cables specified by the manufacturer Observe the information on electromagnetic comp...

Page 10: ...3 Mains connection 10 Control buttons 4 Reset button 11 Progress bar 5 SD slot 12 Function symbols 6 Status bar 13 USB port 7 Operating pilot lamp green 14 HDMI port 4 2 Possible combinations The pro...

Page 11: ...MAC Video Laryngoscope MAC 3 8403AXC C MAC Video Laryngoscope MAC 4 8403BX C MAC Video Laryngoscope MAC 4 8403BXC C MAC Video Laryngoscope MIL 0 8403DXC C MAC Video Laryngoscope MAC 0 8403EXC C MAC V...

Page 12: ...m Order no CMOS Video Rhino Laryngoscope 11101CM CMOS Video Rhino Laryngoscope 11102CM Video Esophagoscope 13303E Video units for urology Item Order no C View Video Cystoscope 11272VU C View Video Cys...

Page 13: ...ower adaptor Weight Approx 130 g SD card Data rate 10 MB s Compatibility Compatible with SD and SDHC cards up to 32 GB class 4 or higher USB stick Compatibility USB 2 0 compatible FAT formatted up to...

Page 14: ...M 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 11303BCX 20 5 25 50 11303BNX 52 45 30 50 11304BCX 52 45 30 50 13303E 52 45 30 5...

Page 15: ...The device must not be modified in any way 4 4 2 Symbols on the product Symbol Meaning Type BF device Power socket CE conformity mark With this mark the manufacturer declares the compliance of the pr...

Page 16: ...NDQ566_EN_V1 0_02 2021_IFU_CE MDR 16 4 5 Ambient conditions Operating conditions Temperature 0 C 40 C Charging conditions rechargeable battery 10 C 60 C Relative humidity non condensing 30 70 Air pre...

Page 17: ...or using 4 screws 2 Press together the holder and slide the holding arm through the holder 3 Release the holder in the desired position The monitor is secured in place on the holding arm 5 3 Connectin...

Page 18: ...using the swivel nut 3 Plug the power supply unit into the wall socket holding onto the plug housing not the cable itself The monitor is connected to the power supply The green indicator on the power...

Page 19: ...kets concerned 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 The video unit connecting cable...

Page 20: ...secondary camera s connector to the camera connection on the left housing side of the product 5 5 Connecting the external monitor The external monitor supports one of the following resolutions 1024 x...

Page 21: ...be formatted on a PC with FAT standard The SD card has only one partition The C MAC monitor is switched off 1 Insert the SD card into the C MAC monitor in the correct position 2 Switch on the C MAC mo...

Page 22: ...s bar Battery charge state Free memory capacity on the connected storage media SD card USB stick Secondary camera connection Progress bar Symbols on the status bar Symbol Meaning Connection of a secon...

Page 23: ...iginal 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...

Page 24: ...rogress of the switch on procedure Shows the progress of the reset Shows the progress of the SD card formatting Shows the progress of emptying the trash Shows the progress of the data export to the US...

Page 25: ...not possible Stop video recording Stops the video recording Video recording stops automatically under the following conditions The battery is empty The SD card is full The device has been switched to...

Page 26: ...the list of saved video recordings Play Plays the selected video recording Pressing the control button switches to the level 2B functions Level 2B Delete Pressing the control button longer deletes th...

Page 27: ...he next level You can move through sev eral levels by repeatedly pressing the menu wheel Wrench Back to level 1 Level 3 White balance Enables the user to run a manual white balance The progress bar in...

Page 28: ...ion process Keep the button held down until the progress bar is complete Menu wheel Activates the functions of the next level You can move through several levels by repeatedly pressing the menu wheel...

Page 29: ...g and confirm by pressing the arrow button Enter the month using and confirm by pressing the arrow button Enter the year using and confirm by pressing the arrow button Pressing the arrow button again...

Page 30: ...product to restart Menu wheel Activates the functions of the next level You can move through several levels by repeatedly pressing the menu wheel Wrench Back to level 1 Level 9 Rotate image Rotates t...

Page 31: ...B port serves exclusively to transfer data from the SD card to the USB stick Data cannot be saved directly to a connected USB stick Before use with the C MAC monitor the USB stick must be formatted on...

Page 32: ...nitor to the power supply SD card full The SD card is full or write protected and will not allow any more data to be saved Remove the write protection or change the SD card No data can be saved to the...

Page 33: ...he monitor to be quickly ready for operation again in the event of brief interruptions Press the On Off button briefly The green status LED flashes The monitor switches to standby mode After 5 minutes...

Page 34: ...re 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 1 Insert a ballpoint pen or similar i...

Page 35: ...ed by KARL STORZ Regardless of the national accident prevention regulations and testing intervals for medical devices for this device safety checks must be performed as repeat inspections according to...

Page 36: ...roduct meets the requirements of the Directive on Waste Electrical and Electronic Equipment WEEE Within the scope of application of this directive KARL STORZ SE Co KG is responsible for the proper dis...

Page 37: ...monitors 8401ZX 8402ZX 8403ZX 8401YB Protective bag blue for C MAC system made from water resistant and hard wearing material washable separate compartments for monitor and three C MAC Video Laryn go...

Page 38: ...004695 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 Article Order no Adaptor for EUROPE ET27 30 0004697 A...

Page 39: ...ic 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 f...

Page 40: ...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...

Page 41: ...e in 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 leve...

Page 42: ...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...

Page 43: ...ers 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...

Page 44: ...or similar Videoendoscope telescope is soiled Videoendoscope contacts are soiled Clean the videoendoscope telescope with a cotton swab and alcohol solution or special cleaning paste Clean videoendosco...

Page 45: ...rite to the SD card SD card is formatted incorrectly SD card is write protected Format the SD card on the PC with FAT standard The SD card must have only one partition Remove the write protection on t...

Page 46: ...RZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 Email asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representation Office K stu io st 59 Lenktoji st 2...

Page 47: ...ding 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 Email info karlstorz com cn KARL STORZ Endoscopy Shan...

Page 48: ...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 NDQ566 EN V1 0 02 2021 IF...