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Electromagnetic compatibility

Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR

21

10 Electromagnetic compatibility

10.1 Electromagnetic compatibility

The described product has been tested as a system with the following devices. Relevant
electromagnetic compatibility (EMC) information can be found in the "Electromagnetic
compatibility (EMC)" section of the instructions for use for the devices.

Device

Article number

C-MAC

®

Monitor

8403ZX

C-MAC

®

Monitor

8404ZX

C-MAC

®

Pocket Monitor

8403XD

C-HUB

®

II

20290320

The EMC warning statements, precautions, notes, and emission/immunity limits specified in
the instructions for use for the devices also apply to the product described in these
instructions for use.

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Содержание C-MAC VS

Страница 1: ...Instructions for use C MAC VS 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 ri...

Страница 3: ...9 5 Preparation 10 5 1 Unpacking the product 10 5 2 Testing the product 10 5 3 Fitting the tube holder 10 5 4 Connecting the product to the C MAC Monitor 10 5 5 Connecting the product to the C MAC Po...

Страница 4: ...e 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 Article number C MAC VS...

Страница 5: ...to Endotracheal intubation with a difficult respiratory tract Endoscopic inspection and monitoring of the mouth nose and throat region Monitoring of percutaneous tracheostomy Anesthesiological bronch...

Страница 6: ...ndling If the product is not handled correctly patients users and third parties may be injured Check the product for the following points before and after every use Completeness Good working order Cor...

Страница 7: ...Distal tip 5 Deflection lever 2 Flexible sheath for deflection 6 Socket for video connecting cable 3 Tube holder 7 Multifunction button BlueButton 4 Handle 8 Ventilation pipe 2 1 Connecting cable 8403...

Страница 8: ...IPX8 Electrical protection class II 4 3 Possible combinations The product can be combined with the following components Monitor CCU Connecting cable C MAC Monitor 8403ZX in software version 704v300 o...

Страница 9: ...ares 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 4 5 Ambient conditions Storage transport conditi...

Страница 10: ...if contaminated 2 Inspect the product for the following characteristics Good working order Functionality Correct assembly of the components Completeness 5 3 Fitting the tube holder 1 Push the tube hol...

Страница 11: ...or lights up green The multifunction button on the product lights up blue 5 If two cameras are connected select the camera for which images are to be displayed from the menu The product is ready for u...

Страница 12: ...cket Monitor can be removed and connected to a different laryngoscope during operation Each time the C MAC Pocket Monitor 8403XD is switched on a blue bar briefly appears at the top of the screen afte...

Страница 13: ...opening it or by removing and inserting it 5 6 Connecting the product to the C HUB II 1 Insert the plug of the connecting cable 8403X into the serial port of the product until you feel a resistance At...

Страница 14: ...ear of the C HUB II The multifunction button on the product lights up blue The product is ready for use 5 7 Focus The image will focus automatically Manual adjustment is not necessary 5 8 Assembling t...

Страница 15: ...Preparation Instructions for use C MAC VS PNO715_EN_V1 0_03 2021_IFU_CE MDR 15...

Страница 16: ...t the endotracheal tube threaded on 2 Press the deflection lever No deflection Distal tip in the neutral position Deflection 90 without tube 60 with the endotracheal tube threaded on 3 If the view is...

Страница 17: ...rd in the monitor 8403ZX 8404ZX or to the internal memory of the C MAC Pocket Monitor 6 3 2 Recording videos 1 Press the multifunction button for around 2 seconds to start video recording A flashing r...

Страница 18: ...ace the distal tip in the neutral position 2 If necessary pull off the endotracheal tube 3 Pull the connecting cable off the C MAC Monitor or C HUB II Remove the C MAC Pocket Monitor from the product...

Страница 19: ...y annually Safety test KARL STORZ service techni cians 8 2 Disposing of the product The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment WEEE Within the sco...

Страница 20: ...MDR 20 9 Accessories and spare parts 9 1 Accessories Item Order no Endoscope holder for C MAC rigid Intuba tion Video Endoscope 10331 BX made of plexiglass distal end open for fixation to a standard r...

Страница 21: ...ectromagnetic compatibility EMC information can be found in the Electromagnetic compatibility EMC section of the instructions for use for the devices Device Article number C MAC Monitor 8403ZX C MAC M...

Страница 22: ...ailed Power supply failure Check power supply Power plug and socket im properly connected Push the power plug firmly into the socket on the product System error Perform reset No picture TFT screen dar...

Страница 23: ...structions for use C MAC VS PNO715_EN_V1 0_03 2021_IFU_CE MDR 23 Fault Possible causes Actions Format the memory card on the PC with FAT Video stream cannot be played back No MPEG 4 codec installed In...

Страница 24: ...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 27...

Страница 25: ...g 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 Shangha...

Страница 26: ...Subsidiaries Instructions for use C MAC VS PNO715_EN_V1 0_03 2021_IFU_CE MDR 26...

Страница 27: ...Subsidiaries Instructions for use C MAC VS PNO715_EN_V1 0_03 2021_IFU_CE MDR 27...

Страница 28: ...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 PNO715 EN V1 0 03 2021 IF...

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