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Content Page
1. Important Information – Read Before Use .....................................................................................................4
1.1. Intended Use/Indications for Use ..........................................................................................................4
1.2. Intended Patient Population ..................................................................................................................4
1.3. Intended User Profile .................................................................................................................................4
1.4. Clinical Benefits ............................................................................................................................................4
1.5. Contraindications ........................................................................................................................................4
1.6. Warnings and Cautions .............................................................................................................................4
1.7. Potential Adverse Events ..........................................................................................................................5
1.8. General Notes ...............................................................................................................................................5
2. Device Description ..................................................................................................................................................6
2.1. Displaying Unit Parts ..................................................................................................................................6
2.2. Product Compatibility ...............................................................................................................................6
2.3. Spare Parts .....................................................................................................................................................6
2.4. Description of Components ...................................................................................................................7
2.5. System Overview .........................................................................................................................................8
3. Explanation of Symbols Used .............................................................................................................................9
4. First-Time Setup .................................................................................................................................................... 10
5. Setting Up the Software .................................................................................................................................... 10
5.1. Software Installation .............................................................................................................................. 10
5.2. How to Log In ............................................................................................................................................. 10
5.3. User Profiles ................................................................................................................................................11
5.4. Language ......................................................................................................................................................14
5.5. Date and Time.............................................................................................................................................14
5.6. Network Setup ............................................................................................................................................15
5.7. PACS and Worklist Setup ........................................................................................................................18
5.8. General Settings ........................................................................................................................................20
5.9. Output Setup ...............................................................................................................................................21
5.10. Endoscope Buttons Configuration...................................................................................................22
6. Connect External Equipment ...........................................................................................................................23
6.1. Connecting to an External Monitor ...................................................................................................23
6.2. Connecting USB Flash Drives ...............................................................................................................23
6.3. Connecting to an External Medical Imaging Recorder .............................................................24
7. Operating the Displaying Unit..........................................................................................................................24
7.1. Preparation and Inspection of the Displaying Unit Before Use ..............................................24
7.2. Preparing and Operating the Ambu Visualization Device .......................................................24
7.3. Live View Functions .................................................................................................................................24
7.4. Archive ...........................................................................................................................................................33
7.5. After Use of the Displaying Unit ..........................................................................................................37
8. System Information and Upgrade ..................................................................................................................38
8.1. Device Information Page ........................................................................................................................38
8.2. Software Update/Upgrade....................................................................................................................38
8.3. Reporting a Problem................................................................................................................................39
8.4. Backup ...........................................................................................................................................................40
9. Cleaning and Disinfection of the Displaying Unit ....................................................................................40
10. Maintenance ..........................................................................................................................................................42
11. Disposal ...................................................................................................................................................................42
12. Technical Product Specifications ..................................................................................................................42
12.1. Standards Applied ...................................................................................................................................42
12.2. Specifications for the Displaying Unit ............................................................................................42
13. Troubleshooting ..................................................................................................................................................44
14. Warranty and Replacement ............................................................................................................................47
Appendix 1. Electromagnetic Compatibility .................................................................................................47
Appendix 2. Radio Frequency Compliance .......................................................................................
..............52
Appendix 3. Cybersecurity .....................................................................................................................................55
Appendix 3.1. Network Setup .......................................................................................................................55
Appendix 3.2. Data at Rest and In Transit ................................................................................................55
Appendix 3.3. Software Bill Of Materials (CBOM) .................................................................................56
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