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Related Manuals for Storz C-MAC VS
Summary of Contents for Storz C-MAC VS
- Page 1 Instructions for use C-MAC VS...
- Page 2 03-2021 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.
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Page 3: Table Of Contents
8.1.1 Maintenance .......................... 19 Disposing of the product ........................ 19 9 Accessories and spare parts ........................ 20 Accessories............................. 20 10 Electromagnetic compatibility........................ 21 10.1 Electromagnetic compatibility ........................ 21 11 Faults and messages .......................... 22 11.1 Product malfunctions.......................... 22 12 Subsidiaries.............................. 24 Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 4: General Information
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. NOTICE ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 5: Normal Use
The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.5 Patient groups There are no restrictions in terms of patient groups for this product. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 6: Safety
3.4 National guidelines on airway management Failure to observe the national guidelines on airway management may put the patient at risk. National guidelines on airway management must be observed in addition to the documentation accompanying the product. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 7: Product Description
Socket for video connecting cable Tube holder Multifunction button (BlueButton) Handle Ventilation pipe Connecting cable (8403X) Connection point for endoscope Monitor connection socket Tube holder (10331BAX) Adaptor for tube fixing Knurled screw Connection for O insufflation Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 8: Technical Specifications
A tube holder (10331BAX) can be used to fix the endotracheal tube to the instrument. 4.4 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Fragile, handle with care Consult the printed or electronic instructions for use Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 9: Ambient Conditions
Temperature 0 °C ... 40 °C Relative humidity 30 – 70 % (non-condensing) Air pressure 700 – 1080 hPa The specifications for the atmospheric pressure can only be guaranteed if the pressure compensation cap is fitted to the ventilation pipe during transportation. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 10: Preparation
Two CMOS video units can be connected to the C-MAC Monitor (8403ZX, 8404ZX) using Lemo connectors. Both connections support all KARL STORZ CMOS videoendoscopes. Insert the plug of the connecting cable (8403X) into the serial port of the product until you feel a resistance. -
Page 11: Connecting The Product To The C-Mac Pocket Monitor
Insert the plug of the C-MAC Pocket Monitor into the serial port of the product until you feel a resistance. At the same time, correctly line up the visible and tangible noses. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... - Page 12 If the memory capacity is less than 10 minutes, the bar is displayed in orange-red. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 13: Connecting The Product To The C-Hub Ii
At the same time, correctly line up the visible and tangible noses. Check whether the cable is fully inserted, no gap should be visible. Attach the connecting cable to the video input on the front of the C-HUB II. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 14: Focus
The image will focus automatically. Manual adjustment is not necessary. 5.8 Assembling the endotracheal tube Push the endotracheal tube onto the product from distal. Surround the distal tip of the product with the endotracheal tube. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... - Page 15 Preparation Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 16: Application
Still images can be saved and video recordings can be documented using the multifunction ® "BlueButton". The documentation procedure can be carried out using the C-MAC Monitor ® (8403ZX, 8404ZX) and the C-MAC Pocket Monitor (8403XD). Functions of the multifunction button are indicated as follows: Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 17: Saving A Still Image
8404ZX) or to the internal memory of the C-MAC Pocket Monitor. Press the multifunction button again to stop video recording. The video stream can only be viewed on a PC if an MPEG 4 codec is installed on the PC. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 18: Disassembly
Pull the connecting cable off the C-MAC Monitor or C-HUB II. Remove the C-MAC Pocket Monitor from the product. Release the adaptor for the tube fixation by turning the knurled screw counterclockwise. Carefully pull out the tube holder. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 19: Maintenance, Servicing, Repairs, And Disposal
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. The product must be disposed of in accordance with the applicable national laws and regulations at a suitable collection point for the reprocessing of electrical and electronic equipment. -
Page 20: Accessories And Spare Parts
Intuba- 10331BXH tion Video Endoscope 10331 BX, made of plexiglass, distal end open, for fixation to a standard rail ® C-MAC Connecting Cable 8403X ® C-MAC Pocket Monitor connecting cable 8403XDP Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 21: Electromagnetic Compatibility
® C-HUB 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. Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 22: Faults And Messages
Memory card full Clean camera plug contacts Memory card is not recog- Insert the memory card nized while the monitor is switched off and then turn the monitor on again Perform reset Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... - Page 23 Faults and messages Fault Possible causes Actions Format the memory card on the PC with FAT Video stream cannot be No MPEG-4 codec installed Install an MPEG-4 played back codec Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 24: Subsidiaries
Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: info-gr@karlstorz.com *Repair & Service Subsidiary Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR... - Page 25 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 26 Subsidiaries Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 27 Subsidiaries Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 28 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...