Related Manuals for Storz C-MAC 8401 Series
Summary of Contents for Storz C-MAC 8401 Series
- Page 1 Instruction For Use ® C-MAC video laryngoscope 8401xxx, Electronic ® Module 8401/8402 X, C-MAC PM 8401 XD...
- Page 2 © KARL STORZ It is not permitted to forward or reproduce this document or to use or disclose the contents thereof unless express consent is given. Publisher KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Tel.: +49 7461 708-0...
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Page 3: Table Of Contents
Table of contents Table of contents 1 General information............................ 5 Reading the instructions for use ....................... 5 Scope................................ 5 2 Intended use .............................. 6 Intended use ............................. 6 Contraindications............................ 6 Target user populations .......................... 6 User qualifications ............................ 6 ® Safety precautions when using the C-MAC video laryngoscope ............ 6 ®... - Page 4 Table of contents 10 Guarantee .............................. 27 11 Standards, directives and regulations ...................... 28 11.1 Standards, directives and regulations .................... 28 11.2 Standard compliance.......................... 28 12 Disposal .............................. 29 13 Technical data............................. 30 14 Fault correction ............................ 32 14.1 Troubleshooting ............................ 32 15 Accessories and spare parts ........................ 34 15.1 Accessories............................. 34 16 Electromagnetic compatibility........................ 35 17 Subsidiaries.............................. 36...
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Page 5: General Information
General information 1 General information 1.1 Reading the instructions for use It is recommended that the suitability of the products for the planned procedure be checked prior to use. These instructions for use are intended to serve as an aid in the proper handling, cleaning and, if need be, sterilization of the C-MAC®... -
Page 6: Intended Use
Intended use 2 Intended use 2.1 Intended use ® The C-MAC video laryngoscope 8401 AX/BX/HX/AXC/BXC/DXC/GXC/KXC/HXP is used in conjunction with the Electronic Module 8401 X/8402 X and the monitor 8401 ZX/8402 ZX/8403 ® ZX or the C-MAC PM for endotracheal intubation and the inspection of the oropharynx. The Monitor 8403 ZX has separate instructions for use (96076008D). -
Page 7: Safety Precautions When Using The C-Mac
PM has been successfully tested on the MIL-STD-461F, RE102 (Fixed Wing). 2.7 Training in the operation and function of the device Your local representative or responsible KARL STORZ member of staff is available to provide training and information on further training alternatives. 2.8 Target patient populations... -
Page 8: Safety
3.4 Correct reprocessing Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection. The instructions for use "Cleaning, Disinfection, Care, and Sterilization of KARL STORZ Instruments" (item no. 96216003) must be downloaded from http://www.karlstorz.com and followed. -
Page 9: Combination With Other Devices And Accessories
Safety Functionality Inspect products for visible contamination before use. Do not use contaminated products. Reprocess the products before use. Do not leave missing or broken-off components inside the patient. 3.6 Combination with other devices and accessories Combinations of medical devices are only assured to be safe if –... -
Page 10: Product Description
Product description 4 Product description 4.1 Product overview ® ® Instruction For Use • C-MAC video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC PM 8401 XD • 96076011EN-US • V3.1... - Page 11 Product description * Models 8401 AXC/BXC/DXC/GXC/KXC/HXP ** 8401 AX/BX/HX with guidance for suction without guidance for suction catheter catheter Laryngoscope blade with holder for elec- Electronic module tronic module Connecting cable for video monitor Function key for video recording Function key for single image capture Video connection socket on laryngoscope blade LED illumination...
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Page 12: Packaging Symbols
Product description 4.2 Packaging symbols Symbol Meaning Consult the instructions for use Keep away from sunlight Keep dry Temperature limit In accordance with US federal law (21 CFR 801.109), this product may only be sold to or on prescription from a licensed physician. Humidity limitation 4.3 Symbols on the product Symbol... - Page 13 Product description 3. Test for proper operation. ® ® Instruction For Use • C-MAC video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC PM 8401 XD • 96076011EN-US • V3.1...
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Page 14: Installation And Commissioning
Installation and commissioning 5 Installation and commissioning 5.1 Visual and functional test Visual inspection The medical device must be inspected for completeness, damage and integrity before and after every use. Tools such as a magnifying glass may be necessary to carry out the inspections. -
Page 15: Initial Operation
Installation and commissioning – Residues and/or moisture present at the interfaces – All components present and correctly positioned – Mobility of all mobile components, if necessary once the components have been assembled in the case of instruments that can be dismantled Test for proper operation Check the instrument for the following characteristics: –... - Page 16 Installation and commissioning Depending on the composition of the image, there may be slight image deterioration in the first 5-8 seconds. ® ® The C-MAC video laryngoscope with C-MAC PM is ready for operation. WARNING Switching off the display ® After 10 minutes, the display of the C-MAC PM turns off automatically and must be turned back on again by closing it and reopening it.
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Page 17: Energy Management
Installation and commissioning 5.2.2 Energy management The battery charge status is shown on the display for the first 10 seconds of operation. ® ® Instruction For Use • C-MAC video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC PM 8401 XD • 96076011EN-US • V3.1... -
Page 18: Putting The Electronic Module Into Service
Installation and commissioning The lithium ion battery can be used for approx. 1 hour when fully charged. WARNING Low battery ® If the charge status symbol flashes red, the charge of the C-MAC PM is too low. In this state, it will only function for another 10 minutes. -
Page 19: Application
Application 6 Application 6.1 Function keys for the video laryngoscope ® Video recording: When the function key "Video recording" (4) is pressed, the C-MAC video laryngoscope saves a video stream on the SD memory card incorporated in the connected Monitor 8403 ZX. Pressing the key a second time stops the recording. The video stream can only be viewed on a PC if an MPEG 4-codec is installed on the PC. -
Page 20: Disassembly
Application 6.4 Disassembly ® 1. Unplug the connecting cable from the C-MAC monitor connection. ® 2. Push the connecting cable or the C-MAC electronic module (2) (Fig. A) from the video ® laryngoscope or the C-MAC PM (12) (Fig. B) out of the video laryngoscope. ®... -
Page 21: Reprocessing
7.1 Cleaning and disinfection CAUTION Damage to the product! Only perform reprocessing using chemicals approved by KARL STORZ. A list of approved chemicals can be requested from hygiene@karlstorz.com. The instructions for use "Cleaning, Disinfection, Care, and Sterilization of KARL STORZ Instruments" (item no. 96216003) must be downloaded from http://www.karlstorz.com and followed. -
Page 22: Manual Cleaning And Disinfection
Reprocessing CAUTION Damage due to corrosion The laryngoscope and electronic module are equipped with gold contacts that prevent corrosion. However, particularly in the case of manual reprocessing, the contacts must be thoroughly rinsed using microbiologically pure/sterile water when rinsed for the last time. Afterwards, the contacts and the instrument must be carefully dried, preferably with sterile compressed air. -
Page 23: Overview Table
Reprocessing ® Clean the optical surfaces of the image chip (8) and LED illuminator (7) on the C-MAC video laryngoscope with a cotton tip applicator soaked in 70% isopropyl alcohol. Electrical contacts must be dried very carefully. 7.4 Overview table Cleaning, disinfection and sterilization ®... - Page 24 Reprocessing ® Chemically sterilize the C-MAC video laryngoscope in dismantled condition. ® ® Instruction For Use • C-MAC video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC PM 8401 XD • 96076011EN-US • V3.1...
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Page 25: Service And Repair
To bridge the repair period, you will generally receive a device on loan, which must then be returned to KARL STORZ as soon as you receive the repaired device. In Germany you can refer repairs directly to: KARL STORZ SE &... -
Page 26: Limitation Of Liability
As a supplier of this instrument, we consider ourselves responsible for the safety, reliability and performance of the instrument only if: Assembly, extension, new adjustments, changes or repairs are carried out by persons authorized by KARL STORZ and the instrument is used in accordance with the instructions for use. -
Page 27: Guarantee
For information concerning the guarantees provided, please see the Standard Conditions of Business of KARL STORZ. The medical device must always be sent to your local subsidiary (see the section ‘Subsidiaries’), even during the warranty period. Opening of the equipment or performance of any repairs or modifications to the equipment by unauthorized persons shall relieve us of any liability for its performance. -
Page 28: Standards, Directives And Regulations
(for 8401 AX, BX, HX, AXC, BXC, DXC, GXC, KXC, HXP, X, XD, ZX, for 8402 X/ZX, 8403 ZX) Complies with EN 60601-1, EN 60601-2-18, UL 2601, CSA 601.1: – Provides Type BF protection when used in conjunction with a KARL STORZ camera control unit with a BF symbol on the connection port. -
Page 29: Disposal
(WEEE). At the end of its useful operating life, dispose of the unit as electronic scrap. Please ask KARL STORZ SE & Co. KG, a KARL STORZ subsidiary or your authorized dealer about the collection point in your area. Within the scope of application of this directive, KARL STORZ SE &... -
Page 30: Technical Data
Technical data 13 Technical data Electronic module 8401 X/8402 X Classification: IEC Class II Line frequency: Voltage: 5 V Power consumption: 2 VA Immersion protection: IPX8 Blade 8401 AX/BX/HX/AXC/BXC/DXC/GXC/KXC/HXP Immersion protection: IPX8 Camera technology CMOS Resolution: 320 x 240 Illumination: LED, white, 1 W Average life cycle Reprocessing cycles: 200*... - Page 31 Technical data Charging station 8401 XDL Classification: IEC Class II Line frequency: Voltage: 5 V Power consumption: 2 VA Weight: Approx. 230 g ® C-MAC PM 8401 XD Line frequency: Voltage: 3.7 V Power consumption: 1.5 W Immersion protection: IPX8 ® ® Instruction For Use • C-MAC video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC PM 8401 XD •...
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Page 32: Fault Correction
– Defective camera – Send electronic module/ ® electronics. C-MAC PM or supply unit to KARL STORZ for – TFT screen defective. repair. Cloudy picture, stripes, – Telescope of the – Clean with cotton swab streaks, or similar. - Page 33 Fault correction Video stream cannot be – No MPEG-4 Codec – Install an MPEG-4 Codec played back on the PC moni- installed. on the PC. tor. SD memory card cannot be – SD memory card is – Format the SD memory written on.
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Page 34: Accessories And Spare Parts
Accessories and spare parts 15 Accessories and spare parts 15.1 Accessories 809125 MAGILL forceps, modified by B OEDEKER, length 25 cm, suitable for the endoscopic removal of foreign bodies, for use with video laryngoscopes of sizes 2 – 4 809120 MAGILL forceps, for children, modified by ... -
Page 35: Electromagnetic Compatibility
Electromagnetic compatibility 16 Electromagnetic compatibility The applied part described in these instructions for use has been tested as a system with the following basic devices. For 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... -
Page 36: Subsidiaries
E-Mail: pisarna@karlstorz.si Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 E-Mail: info@karlstorz.com.ar KARL STORZ Endoskop Polska Marketing Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland KARL STORZ Endoskopi Norge AS Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Stamveien1, 1483 Hagan, Norway E-Mail: info-pl@karlstorz.com... - Page 37 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. E-Mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 38 Subsidiaries ® ® Instruction For Use • C-MAC video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC PM 8401 XD • 96076011EN-US • V3.1...
- Page 39 Subsidiaries ® ® Instruction For Use • C-MAC video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC PM 8401 XD • 96076011EN-US • V3.1...
- Page 40 KARL STORZ SE & Co. KG KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 (0)7461 708-0 Fax: +49 (0)7461 708-105 E-Mail: info@karlstorz.com www.karlstorz.com...