Ambu is a registered trademark and aScope and aView are trademarks of Ambu A/S.
Contents
1. Important information – Read before use......................................................................................................... 5
1.1. Intended use ....................................................................................................................................................................................... 5
1.2. Indications for use............................................................................................................................................................................. 5
1.3. Intended patient population.........................................................................................................................................................5
1.4. Intended user prole........................................................................................................................................................................ 5
1.5. Clinical benets.................................................................................................................................................................................. 5
1.6. Contraindications.............................................................................................................................................................................. 5
1.7. Potential adverse events................................................................................................................................................................. 5
1.8. General notes...................................................................................................................................................................................... 5
1.9. Warnings and cautions.................................................................................................................................................................... 5
2. Device description............................................................................................................................................... 7
2.1. Displaying unit parts........................................................................................................................................................................ 7
2.2. Product compatibility...................................................................................................................................................................... 7
2.3. Description of components........................................................................................................................................................... 8
2.4. Spare parts........................................................................................................................................................................................... 9
2.5. System overview..............................................................................................................................................................................10
3. Explanation of symbols used............................................................................................................................10
4. Getting started ..................................................................................................................................................11
4.1. First-time setup................................................................................................................................................................................11
4.2. User proles ......................................................................................................................................................................................13
4.3. General settings...............................................................................................................................................................................14
4.4. Mounting the displaying unit on a pole ................................................................................................................................14
4.5. Battery and power...........................................................................................................................................................................15
5. Network setup....................................................................................................................................................15
5.1. Wi-Fi and LAN/Ethernet setup ....................................................................................................................................................15
5.2. PACS and Worklist setup...............................................................................................................................................................18
6. Operating the displaying unit .......................................................................................................................... 20
6.1. Preparation and inspection of the displaying unit before use .......................................................................................20
6.2. Setting up endoscope button conguration........................................................................................................................21
6.3. Starting and stopping a procedure...........................................................................................................................................22
6.4. Procedure workow using the Worklist ..................................................................................................................................22
6.5. Overview of Live View functions................................................................................................................................................22
6.6. Using image adjustments.............................................................................................................................................................23
6.7. Using the stopwatch......................................................................................................................................................................25
6.8. Using Dual View ...............................................................................................................................................................................25
6.9. Taking photos and recording videos........................................................................................................................................25
6.10. Current procedure folder ...........................................................................................................................................................26
6.11. After use of the displaying unit................................................................................................................................................26
7. File handling in the Archive .............................................................................................................................. 27
7.1. Accessing les in the Archive......................................................................................................................................................27
7.2. Exporting les to PACS server or USB ash drive.................................................................................................................27
7.3. Deleting les from the Archive...................................................................................................................................................29
8. Connect external equipment............................................................................................................................ 30
8.1. Connecting to an external monitor..........................................................................................................................................30
8.2. Connecting USB ash drives........................................................................................................................................................30
8.3. Connecting an audio device .......................................................................................................................................................30
8.4. Printing images via external medical printer........................................................................................................................31
9. System information and software updates/upgrades....................................................................................31
9.1. Device information page..............................................................................................................................................................31
9.2. Software updates/upgrades........................................................................................................................................................32
9.3. Reporting a problem......................................................................................................................................................................32
9.4. Data reset ...........................................................................................................................................................................................32
10. Cleaning and disinfection of the displaying unit..........................................................................................33
11. Maintenance ....................................................................................................................................................34
11.1. Maintenance of battery ..............................................................................................................................................................34
12. Disposal............................................................................................................................................................35
13. Technical product specications....................................................................................................................35
13.1. Standards applied.........................................................................................................................................................................35
13.2. Specications for aView 2 Advance........................................................................................................................................35
13.3. Specications for aView 2 Advance bracket........................................................................................................................36
13.4. Specications for aView 2 Advance power supply ...........................................................................................................36
14. Troubleshooting .............................................................................................................................................. 37
15. Warranty and replacement ............................................................................................................................. 39
Appendix 1. Electromagnetic compatibility .......................................................................................................40
Appendix 2. Radio frequency compliance...........................................................................................................42
Appendix 3. Cybersecurity....................................................................................................................................45
Appendix 3.1. Network setup .............................................................................................................................................................45
Appendix 3.2. Data at rest and in transit.........................................................................................................................................46
Appendix 3.3. Software Bill Of Materials (SBOM).........................................................................................................................47
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