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Storz C-MAC S, Instructions For Use Manual

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Product description

Instructions for use • C-MAC S PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR

10

4.6 Symbols on the packaging

Symbol

Meaning

Manufacturer

Date of manufacture

Medical device

Unique Device Identifier

Article no.

Number of products in the product packaging

Serial number

Consult the printed or electronic instructions for use

Not MR safe

Federal (USA) law restricts this device to sale by or on the order of a
physician.

CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.

Summary of Contents for C-MAC S

Page 1: ...Instructions for use C MAC S PEDIATRIC IMAGER 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 rights reserved 03 2021 ...

Page 3: ...erview 7 4 2 Overview of accessories 8 4 3 Possible combinations 9 4 4 Technical data 9 4 5 Ambient conditions 9 4 6 Symbols on the packaging 10 5 Preparation 11 5 1 Unpacking the product 11 5 2 Inserting the C MAC S PEDIATRIC IMAGER into the blade 11 5 3 Connection to the C MAC monitor 11 5 4 Connection to the C MAC pocket monitor 13 5 5 Connection to the C HUB II 13 6 Application 16 6 1 Using th...

Page 4: ...tructions for use of the combinable products carefully and follow all the safety notes and warnings 1 3 Scope These instructions for use are valid for the following products C MAC S PEDIATRIC IMAGER 8403XSP Connecting cable 8403X Pressure compensation cap 11025E Leakage tester 13242 XL 1 4 Description of warning messages To prevent any injury to persons or damage to property the warnings and safet...

Page 5: ...dicated if in the opinion of the responsible 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 Laryngo...

Page 6: ...duct is not handled correctly patients users and third parties may be injured Only persons with the necessary medical qualification and who are acquainted with the application of the product may work with it Check that the product is suitable for the procedure prior to use Check the product for the following points before and after every use Completeness Good working order Rough surfaces left inad...

Page 7: ... overview 4 1 2 3 5 6 7 8 1 Telescope 2 C MAC S PEDIATRIC IMAGER 3 Socket for video connecting cable 4 Multifunction button BlueButton 5 Connection for leakage tester or pressure compensation cap 6 Video connecting cable 7 Connection socket for connection to the monitor 8 Connection socket for connection to the C MAC S PEDIATRIC IMAGER ...

Page 8: ...713_EN_V1 0_03 2021_IFU_CE MDR 8 4 2 Overview of accessories 1 2 3 1 C MAC monitor 8403 ZX 2 C MAC S video laryngoscope blade for single use 3 C MAC S video laryngoscope blade for single use with attached C MAC S PEDIATRIC IMAGER and connected C MAC POCKET MONITOR 8403XD ...

Page 9: ...PEDIATRIC IMAGER 8403XSP 051111 01 C MAC POCKET MONITOR 8403XD C MAC monitor 8403ZX software version 704v300 or higher External monitor in combination with C HUB II C HUB II 20290301 For use with an exter nal monitor software version 721v105 or higher 051110 01 4 4 Technical data C MAC S PEDIATRIC IMAGER 8403XSP Classification IEC class n a Line frequency DC Voltage 5 V Power input 2 VA Immersion ...

Page 10: ...Article no Number of products in the product packaging Serial number Consult the printed or electronic instructions for use Not MR safe Federal USA law restricts this device to sale by or on the order of a physician CE conformity mark With this mark the manufacturer declares the compliance of the prod ucts with the applicable regulation EU 2017 745 A code number after the CE mark indicates the res...

Page 11: ...yngoscope blade ð The C MAC S PEDIATRIC IMAGER locks into place with an audible click Check that the C MAC S PEDIATRIC IMAGER is securely in place in the C MAC S video laryngoscope blade by gently moving it to the right and left The distal end of the C MAC S PEDIATRIC IMAGER must lie flat on the lens of the C MAC S video laryngoscope blade The C MAC S PEDIATRIC IMAGER can be removed from the C MAC...

Page 12: ...gap 3 Connect the video connecting cable coming from the C MAC S PEDIATRIC IMAGER to the connection socket at the side 4 or at the rear of the C MAC monitor 5 Switch on the monitor by pressing the power switch The green power switch lamp on the monitor and the blue multifunction button on the C MAC S PEDIATRIC IMAGER light up The devices are now ready for use ...

Page 13: ... on the C MAC S PEDIATRIC IMAGER The orientation pin on the plug of the C MAC PM and the socket of the video laryngoscope blade facilitates connection 2 Make sure that the C MAC PM plug is fully inserted There must not be a gap The monitor can also be opened up when connecting both components The devices are now ready for use Once the C MAC PM has been opened up the TFT display will be activated a...

Page 14: ...te is required for the C HUB II 1 Connect the video connecting cable to the socket on the C MAC S PEDIATRIC IMAGER The orientation pin on the video connecting cable and connection socket facilitates connection 2 Make sure that the cable is fully inserted There must not be a gap 3 Connect the video connecting cable coming from the C MAC S PEDIATRIC IMAGER to the video input on the front of the C HU...

Page 15: ... for use C MAC S PEDIATRIC IMAGER PNO713_EN_V1 0_03 2021_IFU_CE MDR 15 ð The lamp on the front of the C HUB II and the multifunction button on the C MAC S PEDIATRIC IMAGER light up permanently The devices are now ready for use ...

Page 16: ...ght If memory capacity is less than 10 minutes the bar is displayed in orange red Data can only be stored on the C MAC monitor 8403ZX or 8404ZX if there is an SD memory card inserted into the monitor Single image capture Briefly press the multifunction button to activate single image capture ð The current image on the screen is saved on the SD memory card inserted into the connected monitor 8403ZX...

Page 17: ... the ejection mechanism on the side of the C MAC S laryngoscope blade 2 Take hold of the C MAC S PEDIATRIC IMAGER by the coupling mechanism between the connecting cable or C MAC PM and C MAC S PEDIATRIC IMAGER and pull the IMAGER out of the C MAC S video laryngoscope blade 3 Remove the connecting cable or C MAC PM from the C MAC S PEDIATRIC IMAGER ...

Page 18: ...act infections and airborne infections products must first be decontaminated KARL STORZ reserves the right to send back contaminated products 8 2 Disposing of the product The product 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 disposal of this product 1 ...

Page 19: ...m interface to C MAC video laryngo scope 8403xxx and C MAC PM 8403XD as well as C MAC connecting cable 8403X for protecting the plug contacts during reprocessing cap is reusable for use with C MAC connecting cable 8403X C MAC PM 8403XD C MAC video laryngoscopes 8403xxx electronics modules 8401X 8402X and flexible intubation video endoscopes FIVEs 8403YZ Leakage tester with blower and manometer 132...

Page 20: ...stem error Check the power supply Push the power supply plug firmly into the socket on the device Reset No picture TFT screen dark Connecting cable to C MAC monitor C MAC PM not connected properly Defective camera electronics TFT screen defective Connect the connecting cable to the C MAC monitor C MAC PM correctly Send C MAC PM or supply unit to KARL STORZ for repair Color distortions White balanc...

Page 21: ...ER PNO713_EN_V1 0_03 2021_IFU_CE MDR 21 Description of issue Possible causes Remedy Format the memory card on the PC with FAT standard SD memory card cannot be written on SD memory card is formatted incorrectly Format the SD memory card on the PC with FAT standard ...

Page 22: ...relevant 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 8403 ZX 96076008 D C MAC Pocket Monitor 8403 XD 96076020 D C HUB II 20 2903 20 96206529 D The EMC warning statements precautions notes and Emission Immunity limits specified in the instructi...

Page 23: ...KARL STORZ 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 Kęstučio st 59 Lenktoji st 27 08124 Vilnius Lithuania Phone 370 5 272 0448 Mobile 370 685 67 000 Email info lt lv karlstorz com KARL STORZ Endoskopi Danmark A S Skovlytoften 33 2840 Holte Denmark Phone 45 45162600 Fax 45...

Page 24: ...7 Building 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 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...

Page 25: ...Subsidiaries Instructions for use C MAC S PEDIATRIC IMAGER PNO713_EN_V1 0_03 2021_IFU_CE MDR 25 ...

Page 26: ...Subsidiaries Instructions for use C MAC S PEDIATRIC IMAGER PNO713_EN_V1 0_03 2021_IFU_CE MDR 26 ...

Page 27: ...Subsidiaries Instructions for use C MAC S PEDIATRIC IMAGER PNO713_EN_V1 0_03 2021_IFU_CE MDR 27 ...

Page 28: ...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 PNO713 EN V1 0 03 2021 IFU CE MDR ...

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