Related Manuals for Storz C-MAC 8403 Series
Summary of Contents for Storz C-MAC 8403 Series
- Page 1 Instruction For Use ® C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X...
- 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 Product description ............................ 6 Product overview ............................ 6 Packaging symbols........................... 8 Symbols on the product ........................... 8 3 Intended use .............................. 9 Intended purpose............................ 9 Contraindications............................ 9 Target user populations .......................... 9 Training in the operation and function of the device ................ 9 Target patient populations ........................ 9 User qualifications ............................ 9... - Page 4 Table of contents 7.10 Sterilization ............................. 28 ® 7.10.1 Hydrogen peroxide (H₂O₂) sterilization - ASP STERRAD ............ 28 ® ® 7.10.2 Hydrogen peroxide (H₂O₂) sterilization - STERIS AMSCO V-PRO™ 1 ........ 29 7.10.3 Ethylene oxide sterilization (EO) .................... 29 ® ® 7.10.4 Chemical low-temperature sterilization with peracetic acid –...
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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, ®... -
Page 6: Product Description
Product description 2 Product description 2.1 Product overview ® Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3... - Page 7 Product description Models 8403 AXC/BXC/DXC/EXC/GXC/KXC/MXC/HXP 8403 AX/BX/HX with guidance for suction catheter without guidance for suction catheter ® C-MAC Video Laryngoscope Socket for video connecting cable (4) Multifunction button (BlueButton) Video connecting cable Connection socket on monitor Connection socket on laryngoscope ®...
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Page 8: Packaging Symbols
Product description 2.2 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 2.3 Symbols on the product Symbol... -
Page 9: Intended Use
3.4 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. 3.5 Target patient populations... - Page 10 Intended use – No physical impairments that could diminish perception of activation and alarm signals (visual and acoustic) ® Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3...
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Page 11: Safety
Safety 4 Safety 4.1 Serious incidents A "serious incident" includes, according to MDD incidents, those which, directly or indirectly, had, could have had or could have any of the following consequences (MDD, Art. 2, No. 65 [1]): – Death of a patient, user, or another person –... -
Page 12: Risks From Electric Current
Safety 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. ð This is not applicable to U.S. market. 4.6 Risks from electric current If several products supplied with energy are used simultaneously, the patient leakage currents accumulate. - Page 13 Safety ® – The C-MAC video laryngoscopes may not be sterilized with steam. ® Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3...
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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 Test for proper operation Check the instrument for the following characteristics: – Fully functional control keys – Securely positioned connecting cable – Functional image transmission – Sufficient image quality – Light transmission 5.2 Initial operation ® The C-MAC video laryngoscopes 8403 xxx can be operated with the following monitors: ®... - Page 16 Installation and commissioning WARNING Optical radiation The optical radiation of the instrument can injure the eyes of patients, users, and third parties. Never look into the light output of a connected light transmission or endoscope. Wear suitable protective equipment. ® To prevent the telescope from fogging up, the C-MAC , video laryngoscope should not be cooled below 18°C (64.4°F) and should be switched on in good time to allow the optical...
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Page 17: Application
(12) (primary connection) or the connection socket (11) of the C-MAC monitor. The Monitor 8403 ZX enables two CMOS video units from KARL STORZ to be connected with Lemo connectors. Video units from other manufacturers cannot be connected. -
Page 18: Connection To The C-Mac Pocket Monitor
Application If two cameras are connected, the user must select the camera for which the images are to be ® displayed in the menu (refer to the instruction manual for the C-MAC monitor 8403 ZX Art. no. 96076008D). Switch on the monitor by pressing the power switch (18). The green power switch lamp (17) on the monitor and the blue multi-function button (3) of the video laryngoscope go on. -
Page 19: Switching On The "Open-To-Intubate (Oti) Displays
Application ® When inserting the C-MAC PM into the video laryngoscope always ensure that the lugs of the plug connection are opposite each other. 6.2.1 Switching on the "Open-to-Intubate (OTI) displays" ® If the C-MAC PM is closed when connected to the video laryngoscope blade, the following steps must be performed (Fig. -
Page 20: Switching Off The "Open To Intubate" (Oti)-Displays
Application The image focus is adjusted automatically. Manual adjustment is not necessary. ® ® The C-MAC video laryngoscope with C-MAC PM is ready for operation. 6.2.2 Switching off the "Open to intubate" (OTI)-Displays 1. Turn the OTI display (8) to the right (Fig. D). 2. -
Page 21: Connection To The C-Hub
Application ® ® You can disconnect the C-MAC PM from the C-MAC video laryngoscope during ® operation and connect it to another C-MAC video laryngoscope without turning off the C ® -MAC WARNING Switching off the display ® After 10 minutes, the display of the C-MAC PM turns off automatically. -
Page 22: Multifunctional Button Of The Video Laryngoscope
Application ® 3. Connect the monitor to the S-Video or HDMI output on the rear of the C-HUB 6.4 Multifunctional button of the video laryngoscope Both single-image capture and video recording can be activated using the multifunctional button (3) on the video laryngoscope. Documentation with the multifunctional button of the ®... -
Page 23: Color Coding Meanings For The "Blue Button" Multifunction Button
Application 6.4.1 Color coding meanings for the "Blue Button" multifunction button ® Once the multifunction button on the C-MAC video laryngoscope lights up blue, videos and images can be recorded. The colors of the multifunction button have the following meanings: Blue: Permanently lit. -
Page 24: Insertion Of An Oxygen Or Suction Catheter (Only With 8403 Ax/Bx/Hx)
Application The video stream can only be viewed on a PC if an MPEG 4-codec is installed on the PC. ® If memory capacity for the C-MAC PM 8403 XD is less than 10 minutes, the information bar is displayed in orange-red. 6.4.4 Insertion of an oxygen or suction catheter (only with 8403 AX/ BX/HX) If a blade with oxygen or suction catheter guide is used, the probe/catheter must be advanced over the guide until visibility in the image is guaranteed. -
Page 25: Reprocessing
On the grounds of potential damage, this reprocessing step must NEVER be per- formed. NO symbol: This reprocessing step has neither been validated in respect of efficacy nor in respect of material compatibility by KARL STORZ. 7.2 General warnings (worldwide, does not apply to USA and Canada) - Page 26 Bear in mind the microbiological range of action of the chemicals used. 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. ® As a general rule, all system components 8403 xxx C-MAC video laryngoscopes and C- ®...
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Page 27: Preparation For Cleaning And Disinfection
The following machine decontamination procedures have been validated and approved in accordance with the process parameters described in the manual "Cleaning, Disinfection, Care and Sterilization of KARL STORZ Instruments" (Art. No. 96216003D). The selection of a suitable slide-in tray or instrument holder, which should ensure that the medical device is thoroughly rinsed out or through, must take place in consultation with the manufacturer of the device. -
Page 28: Assembly, Inspection And Care
The procedures as well as the process-relevant parameters for the individually validated methods are described in the manual "Cleaning, Disinfection, Care and Sterilization of KARL STORZ Instruments" (Art. no. 96216003D). The method must be selected taking into account the respective applicable national requirements and in consultation with the device and product manufacturers. -
Page 29: Hydrogen Peroxide (H₂O₂) Sterilization - Steris
Reprocessing ® – STERRAD 50, 100S, 200 without booster ® ® – STERRAD Standard Cycle ® ® – STERRAD 100NX Standard Cycle ® ® 7.10.2 Hydrogen peroxide (H₂O₂) sterilization - STERIS AMSCO PRO™ 1 Detailed information on choosing the appropriate cycles in the various device generations is ®... -
Page 30: Reprocessing Limits
Reprocessing 7.11 Reprocessing limits The end of the device's life span is largely determined by wear, reprocessing methods, the chemicals used and any damage resulting from use. ® Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3... -
Page 31: Reprocessing Usa And Canada
NO symbol: This reprocessing step has neither been validated in respect of efficacy nor in respect of material compatibility by KARL STORZ. 8.2 General warnings (applies only to USA and Canada) These products are not sterile when delivered. The use of unsterile products poses a risk of infection for patients, users, and third parties. -
Page 32: Brushing The Surfaces
Reprocessing USA and Canada 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. ® As a general rule, all system components 8403 xxx C-MAC video laryngoscopes and C- ®... -
Page 33: Assembly, Inspection And Care
STERRAD devices. ® The following STERRAD sterilization methods have been validated and approved for this medical device by KARL STORZ: ® Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3... -
Page 34: Hydrogen Peroxide (H₂O₂) Sterilization V-Pro Steris Amsco Vv-Propro
Reprocessing USA and Canada ® – STERRAD 50, 100S, 200 without booster ® ® – STERRAD Standard Cycle ® ® – STERRAD 100NX Standard Cycle 1. Place the device in a FDA-cleared sterilization tray. 2. Double wrap the sterilization tray with polypropylene wrap. 3. -
Page 35: Chemical Low-Temperature Sterilization With Peracetic Acid - Steris System 1E
Reprocessing USA and Canada 3. Start the sterilization using the following parameters: Conditioning Parameters: Temperature: 55°C (131°F) Humidity: 70% relative humidity Conditioning dwell time: 30 minutes Sterilization Parameters: Sterilant: 100% ethylene oxide Temperature: 55°C (131°F) Gas concentration: 735±30 mg/l Exposure Time: 180 minutes Aeration Parameters Time: At least 12 hours Temperature: 55°C (131°F) -
Page 36: High-Level Disinfection
2. Place device in disinfectant solution. Ensure that no air bubbles are present on the surface of the device. 3. The following KARL STORZ validated conditions must be met to achieve high-level disinfection: – CIDEX: Immerse for 45 minutes at 25°C (77°F). -
Page 37: 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 38: 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 39: 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 40: Electromagnetic Compatibility
Electromagnetic compatibility 12 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 41: Standards, Directives And Regulations
(for 8403 AX, BX, HX, AXC, BXC, DXC, EXC, GXC, KXC, MXC, HXP, X, XD, 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 42: 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 43: Technical Specifications
Technical specifications 15 Technical specifications Video laryngoscope 8403 AX/BX/HX/AXC/BXC/KXC/HXP Immersion protection: IPX8 Camera technology CMOS Resolution: 640 x 480 Illumination: LED, white, 1 W Video laryngoscope 8403 DXC/EXC/GXC/MXC/NXC Immersion protection: IPX8 Camera technology CMOS Resolution: 300 x 400 Illumination: LED, white, 1 W ®... -
Page 44: Fault Correction
– Defective camera – Send electronics 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. laryngoscope is soiled. - Page 45 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 46: Accessories And Spare Parts
Accessories and spare parts 17 Accessories and spare parts 17.1 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 47: 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 48 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 49 Subsidiaries ® Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3...
- Page 50 Subsidiaries ® Instruction For Use • C-MAC Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3...
- Page 51 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...